Effectiveness of palliative home care on clinical, emotional and economic well-being at the end of life: a narrative review

Vincenza Giordano ¹, Assunta Guillari ², Aniello Lanzuise ³, Michele Virgolesi ^2*,

Lidia Di Vaio ⁴& Teresa Rea ²

Department of General Surgery and Women's Health, A.O.R.N. (Hospital Company of National Significance) Antonio Cardarelli, Naples (Italy).
Department of Public Health, University Federico II of Naples, Naples (Italy).
Corporate Health Management, A.O.R.N. (Hospital Company of National Significance) Sant'Anna e San Sebastiano, Caserta (Italy).
School of Medicine and Surgery, University Federico II of Naples, Naples (Italy).

* Corresponding author: Michele Virgolesi Ph.D., Department of Public Health, University Federico II of Naples, Sergio Pansini street no. 5, 80131, Naples (Italy). Email: michele.virgolesi@unina.it

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ABSTRACT

Introduction: Palliative home care is essential for terminally ill patients. This integrated approach is not limited to physical care, but also embraces the psychological, social and spiritual aspects of the patient. This model of care, focused on the patient and their family, aims to ensure quality health care during the advanced stage of a disease. In addition, by reducing the need for hospital admissions, palliative home care reduces costs, providing a sustainable alternative for the health system.

Objective: To describe the knowledge related to the clinical, emotional and economic impact of palliative home care in cancer patients

Materials and Methods: A narrative review was conducted using databases such as PubMed, Cinahl and Cochrane Library between December 2023 and March 2024, using the Population, Intervention, Outcome (PIO) methodology. The survey generated 551 articles, of which only 6 were relevant to the study. The selection of studies was guided by inclusion and exclusion criteria, with a quality assessment using the Dixon Woods instrument.

Results: The studies included in the review have demonstrated a positive and significant impact of palliative home care on the well-being and quality of life of terminal cancer patients. Some of these studies have examined the clinical efficacy of such treatments in mitigating the patient's symptoms, with conflicting results: while some have shown positive efficacy, others have not found the same result. Regarding the cost-effectiveness, the analysis highlighted a lack of definitive evidence on the possible economic advantage of palliative home care compared to hospital care.

Conclusions: Palliative home care emerges as a crucial element in the nursing care of the terminally ill cancer patient: it offers essential psychological support, enabling patients to feel understood and listened to with regard to their needs and requirements. However, there are some discrepancies, particularly with regard to economic effects and symptom control.

Keywords: palliative home care; terminal care; quality of care; quality of life; cost-effectiveness analysis.

INTRODUCTION

Cancer represents one of the most significant global public health challenges of our time, with a significant and tangible impact on the lives of patients and their families [1,2]. Updated estimates by the International Agency for Research on Cancer (IARC), report almost 20 million new cancer cases worldwide (including non-melanoma skin cancers – NMSC) and 9.7 million cancer deaths (including NMSC). Data indicate that about one in five men or women develop cancer during their lifetime, while about one in nine men and one in 12 women die from it [3].

Over the years, the efforts of the scientific community have focused on improving the quality of life of cancer patients, who find themselves facing complex and challenging obstacles due to the disease. In this perspective, palliative care (PC), understood as the "active and holistic care of individuals of all ages with significant health-related suffering due to serious illness, and especially those nearing the end of life" [4] aims to improve the quality of life of patients, their families and caregivers. [5]

The typical patient undergoing palliative care for advanced cancer is often an older or elderly person with a diagnosis of metastatic or locally advanced malignancy, where curative options are limited or unavailable. This individual has probably been through numerous lines of cancer treatment, including surgery, chemotherapy and radiotherapy, which over time have led to a progressive reduction in quality of life due to cumulative side effects and the disease itself [6]. The clinical condition is characterised by complex and multidimensional symptoms, such as chronic pain, dyspnoea, pronounced asthenia, cachexia, and gastrointestinal symptoms such as nausea and constipation. The patient may also manifest cognitive disorders or psycho-emotional symptoms, such as anxiety, depression and a sense of loss of autonomy, which reflect the heavy psychological impact of the terminal illness [7].

From the socio-familial point of view, the patient is often surrounded by a support network of close family members, but is confronted with the difficulty of having to accept the increasing dependence on others for activities of daily living. Often, this person is in ongoing dialogue with the palliative care team to manage symptoms and make shared decisions about end-of-life care while seeking to maintain some dignity and comfort in the remaining time [8].

According to the World Health Organisation (WHO), PC represents one of the fundamental pillars of health care, involving more than 56.8 million people worldwide annually [9,10]. In Italy, about 1–1.4% of the population needs palliative care, recognised as an integral part of the human right to health [11,12]. In this context, palliative home care plays a crucial role. Palliative home care, in fact, is reflected in a model of care focused on the person, aimed at ensuring high-quality health care [5]. On the physical side, they alleviate debilitating symptoms associated with disease, such as pain, nausea and vomiting, reducing the cancer patient's physical suffering and improving his or her clinical well-being through pharmacological and non-pharmacological therapies [13, 14]. On the emotional level, they offer complete psychological support to the patient and their family members, helping to meet their needs, in order to mitigate emotional distress and achieve spiritual balance [14-16]. This approach not only improves the quality of life of the terminally ill patient, but also alleviates the stress and anxiety of family members, creating a comfortable environment [17]. In the context of home care, nurses play a fundamental role in the delivery of palliative care, often representing the first point of contact for cancer patients. Growing evidence demonstrates the significant positive impact nurses have on the quality of care provided, improving symptom management, emotional support and overall coordination of care [18]. They are committed to creating a safe and efficient home environment, actively collaborating with the patient and family [18]. They instruct the latter on self-care techniques and the use of necessary medical equipment, promoting their autonomy [19]. They plan home care according to individual needs, constantly monitor the patient's clinical conditions and adapt interventions in a timely manner, acting promptly when necessary [19]. Finally, during the terminal stages of the disease, they provide support to the patient and caregivers, aimed at ensuring dignity and peace of mind, facilitating a respectful transition to death [12]. In addition, a study revealed that home care for cancer patients not only optimises their satisfaction, but also results in a more positive experience with a significant reduction in healthcare costs [20]. Patients receiving palliative home care are less likely to be hospitalised or go to the emergency room than those receiving standard care. This helps to reduce the frequency of hospital admissions, days spent in hospitals or care facilities, and medical services used, thus lowering the overall costs of end-of-life care [20-22]. It is estimated that care costs are reduced by about 34% in patients managed through PC compared to those who do not have access to PC.

In light of this, investigating the clinical, emotional and economic effectiveness of palliative home care appears to be of strategic importance in order to improve the approach to end-of-life care for cancer patients.

Objective

To describe the knowledge related to the clinical, emotional and economic impact of palliative home care in cancer patients

MATERIALS AND METHODS

A narrative review was conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement (PRISMA) [23] and the guidelines for writing a narrative review to be published in peer-reviewed journals [24].

Study design

The research aims to answer the following question, formulated according to the Population, Intervention, Outcome (PIO) methodology: To what extent does palliative home care help to ensure clinically, emotionally and economically effective care for patients with terminal cancer over the age of 18?

The PIO defines the population subject to analysis, the intervention to be implemented and the outcomes (Table 1).

P	Patients > 18 years of age with terminal cancer
I	Palliative home care
O	Clinical, emotional and economic effectiveness

Table 1. Question according to the PIO method.

Research strategy

Bibliographic research was conducted in the period between the end of December 2023 and March 2024, consulting the following scientific databases: PubMed, Cinahl, and the Cochrane Library. The keywords used for the research were: "palliative care", "palliative home care", "home care services", "home-based palliative care", "cancer", "cancer patients", "terminally ill", "terminal cancer", "quality of care", "quality of life", "cost-effectiveness analysis", "nurse-patient relations". The keywords were combined through the use of the Boolean operators "AND" and "OR", which made it possible to filter the results and make the search more specific.

Subsequently, to obtain general information on palliative care, websites of national bodies and

scientific associations were consulted. These include the official websites of the Istituto Superiore della Sanità and the Ministry of Health, as well as those of associations such as the Italian Society of Palliative Care (SICP), the Italian Association of Medical Oncology (AIOM), the Italian Association of Cancer Patients (AIMAC) and the European Society for Medical Oncology (ESMO).

Inclusion and exclusion criteria

During the first phase of research and the selection of studies, specific inclusion and exclusion criteria were defined for the various databases, such as PubMed, Cinahl and the Cochrane Library. A restricted time criterion was applied, limiting the survey to articles published between 2019 and 2024. We included: a) primary studies; b) secondary studies; c) articles on patients with cancer over the age of 18; d) articles in English and Italian; e) articles available free of charge for the abstract and full text.

The following were excluded: a) studies concerning patients with oncological diseases under the age of 18 years and those concerning patients with non-oncological diseases; b) articles published before 2019 or which did not meet the stipulated time interval; c) articles written in a language other than English or Italian.

Selection of studies

The survey yielded a total of 551 articles (389 on PubMed, 80 on Cinahl and 82 from the Cochrane Library).

The articles obtained from the three databases were analysed in the preliminary phase. 17 duplicate articles were excluded. The remaining 534 were examined by title and abstract. Of these, 485 were discarded because they were not relevant to the main theme or were inconsistent with the inclusion criteria. Of the 49 remaining articles, the full text was examined. Of these, 43 were excluded from the review because they were not suitable for the search objective and inclusion criteria when reading the full text; 6 articles were included.

The method used in the selection of articles for this review is illustrated below in a flowchart compliant with the PRISMA-ScR (PRISMA Extension for Scoping Reviews) methodology [20]. This diagram highlights the final choice of the included articles (Figure 1).

Figure 1. Flowchart model of PRISMA-ScR (PRISMA Extension for Scoping Reviews).

Quality Assessment

To assess the methodological quality and homogeneity of the studies included in the review, the method proposed by Dixon-Woods was used by means of a specific checklist [25]. This checklist comprises five domains to assess the methodological quality of the studies, and each article was assigned an overall rating based on the assessment of these domains. Studies that received a score of less than 3 "yes" answers were excluded from the analysis. Those with 3 "yes" answers were considered discrete, while studies with 4 "yes" answers were classified as good and those with 5 "yes" answers were considered to be of excellent quality (Table 2).

*Author(s), year*	Are the aims and objectives of the research clearly stated?	Is the research design clearly specified and appropriate to the purposes and objectives of the research?	Do the researchers provide a clear account of the process by which their results were reproduced?	Do researchers present enough data to support their interpretations and conclusions?	Is the method of analysis appropriate and adequately explained?	SCORE
Patel et al., 2023	YES	YES	YES	YES	YES	Excellent
Riolfi al., 2021	YES	YES	YES	YES	YES	Excellent
Shepperd et al., 2021	YES	YES	YES	YES	YES	Excellent
Biswas al., 2022	NO	YES	YES	YES	YES	Good
Constantinou et al., 2022	YES	YES	YES	YES	YES	Excellent
Kim et al., 2022	YES	YES	YES	YES	YES	Excellent

Table 2. Quality appraisal according to Dixon-Woods scale

RESULTS

The results of the review highlighted six studies relevant to the research objective. These include two quantitative cross-sectional studies [26,27], a study using mixed methods [28], a retrospective study [29], a systematic review [30], and finally a cost-effectiveness study [31]. The studies were conducted in several countries, including Bangladesh [26], the Republic of Cyprus [27], India [28], Italy [29], the United Kingdom [30] and Korea [31]. The studies selected by the review involve a total of 1702 patients with cancer. 68 patients participated in the mixed study [28], 375 patients in the retrospective cohort study [29], 1128 patients in the systematic review [30], while 131 patients were involved in the remaining quantitative cross-sectional studies [26,27]. The cost-effectiveness analysis considered a hypothetical cohort of patients with terminal cancer [31]. In two studies [28,29], patients enrolled were predominantly male; in one observational study [26], by contrast, 76.5% of patients were female. Only in one study were there similar proportions between men and women [30]. Of the six included studies, the mixed method study compared palliative home care with hospice care [28], while two studies [30,31] compared palliative home care with the usual palliative care in inpatient units. The main characteristics of the studies are summarised in the following summary table (Table 3);

Author, year	Study design	Population	Country in which the study was carried out	Goal of the study	Results
Biswas al., 2022 [26]	Cross-sectional study	n=51 terminal cancer patients	Bangladesh	Assessing the quality of life of patients with cancer illnesses receiving palliative home care. Identify the factors that influence physical well-being and symptom control.	Palliative home care proved effective in promoting social and emotional well-being for the majority of patients included in the study. However, it showed limited effectiveness in controlling symptoms.
Constantinou et al., 2022 [27]	Cross-sectional study	n=80 patients with cancer	Republic of Cyprus	Conducting an analysis of the quality and effectiveness of palliative care delivered at home, while assessing the level of patient satisfaction.	Participants rated the overall quality of palliative home care positively, highlighting a satisfactory level of psychological support.
Patel et al., 2023 [28]	Mixed method study	n=68 patients with terminal cancer	India	Examining how patients with terminal cancer perceive the quality of palliative care in different contexts and measuring quality of life.Inizio modulo	- Positive impact on the QoL of the terminal patient both at home and in the Hospice. The need to expand access to palliative care, increasing its coverage.
Riolfi al., 2021 [29]	Retrospective cohort study	n=375 cancer patients	Italy	Examining the effectiveness of palliative home care in reducing costs by minimising admissions to acute care facilities.	Palliative home care reduces hospital admissions and hospital days in the last two months of life, while increasing the probability of death at home, ensuring the patient's well-being at the end of life.
Shepperd et al., 2021 [30]	Systematic review	n=1128 patients in the terminal stage	United Kingdom	Examining the effectiveness of palliative home care in reducing the likelihood of death in the hospital setting, in mitigating patient symptoms, in reducing health system costs, as an alternative to hospital and hospice care	Palliative home care increases the likelihood of death at home for the patient. Uncertainty persists regarding symptom control and the impact on health system costs.
Kim et al., 2022 [31]	Cost-effectiveness analysis study	Hypothetical cohort of terminal cancer patients who have benefited from palliative home care.	Korea	To investigate the economic advantage of palliative home care compared to hospital care.	Palliative home care can result in a doubling of expenses compared to hospital care. However, the cost-benefit outcome is uncertain.

Table 3. Summary of the selected studies

Clinical effectiveness

Two studies included in the review show a positive effectiveness of palliative home care in alleviating patients' symptoms [28,29], while others do not find the same result [26,30]. The study by Riolfi et al. [26] showed that patient care by palliative home care services improves the control of psycho-physical symptoms that occur towards the end of life. Similarly, Patel et al. [28] highlighted effective symptom management by the home care team. In contrast, the research by Biswas et al. [26] found below-average physical well-being in 60.8% of the patients included in the survey, who complained of feeling sick (54.9%), lack of energy (43.1%), and pain (47.1%). The study calls for more research aimed at improving interventions for symptoms. Finally, the study conducted by Shepperd et al. [30] shows uncertain outcomes on symptom control.

Emotional effectiveness

Three studies [26-28] have highlighted the positive impact of palliative home care on the well-being and quality of life of patients with cancer. In the study by Biswas et al. [26], 92.1% of patients who received palliative home care demonstrated above-average emotional and social well-being. However, the greater well-being seems to be related to the duration of the care provided (> months) and to a less ominous prognosis. The investigations by Constantinou et al. [27] and Patel et al. [28] also reveal that palliative home care guarantees greater psychological support.

Cost effectiveness

The impact of palliative home care on health system costs has been the subject of conflicting considerations among the various studies included in the review. The study conducted by Riolfi et al. [29] indicates potential savings thanks to palliative home care that reduces costs related to hospitalisation, access to the emergency room and days in hospital. In contrast, the systematic review conducted by Shepperd et al. [30] highlighted a certain degree of uncertainty regarding the effect of home services on health system costs. The study conducted by Kim et al. [31] also revealed ambiguous and inconclusive results.

DISCUSSION

This review provided an analysis of the clinical, emotional and economic effectiveness of home palliative care for terminal cancer patients. A positive and significant effect of such treatments on patients' psychological well-being was found, in line with studies conducted by Biswas et al^.[26], Constantinou et al. [27] and Patel et al. [28]. Home care has been shown to offer essential psychological support, enabling patients to feel understood and listened to about their needs and alleviating the emotional burden of illness. The choice to die at home promotes the emotional well-being of terminal patients, maintaining normality and social integration until the end of life [29-31]. Family support offers spiritual and emotional comfort, reducing anxiety and discomfort. Indeed, none of the research conducted showed that patients prefer to die in a hospital environment rather than in their home environment. However, only a fraction of the estimated total of patients who require it manage to benefit from it. A 2019 study, based on data collected through the palliative home care monitoring portal, showed that in 2013, 38,384 cancer patients were assisted by home care units [32], while many others could not benefit from such services. The Italian reality, therefore, does not guarantee uniform coverage throughout the country; suffice it to say that, at present, only 59% of the local health authorities have an active palliative care network, highlighting the urgent need to expand access [29,33]. The lack of studies conducted specifically in Italy is also a significant limitation in understanding the clinical, emotional and economic effectiveness of home palliative care in the terminal cancer patient. In fact, only one study [29] considered this scenario, whereas the other surveys included in the review refer to different countries. It is well known that differences in health care systems, available resources and modes of care between countries can greatly influence the results of studies and complicate the extension of results in a different context.

One study suggests potential cost savings through home-based services [29], while others, such as the research by Shepperd et al. [30] and Kim et al. [31], point to uncertainties or a lack of significant differences in costs compared to hospital care. It is not yet clear whether home care is more beneficial in terms of results and costs for terminal cancer patients. This highlights the need for further research on the economic impact of palliative home care. Although the cost-effectiveness analysis is not conclusive, the lack of negative impacts on other results could justify the implementation of home services to meet the needs of patients.

Similarly, with regard to symptom control, a diversity in results has emerged that highlights the importance of adopting personalised approaches to manage them effectively.

Palliative home care brings emotional benefits, but uncertainties remain regarding its effectiveness in controlling symptoms and its economic impact compared to hospital care. It is essential to consider patient diversity when designing personalised strategies. Further detailed research is needed to examine these aspects. Despite this, the implementation of home care programmes for end of life seems promising, but it is essential to improve and expand services to respond to the growing demand and ensure adequate support for patients in their home environment.

In this context, the nurse assumes a vital role in offering complete and patient-centred care, designing a personalised care plan. Through specialised training and constant professional updating, the nurse is able to guarantee high-quality palliative care, working in close collaboration with the other professionals in the palliative care team. This multidisciplinary approach ensures that the physical, emotional and spiritual needs of the patient are adequately met [34]. Using their skills, the nurse educates the patient on the management of typical symptoms that can occur during the terminal phase of cancer, such as pain, nausea and dyspnoea, teaching the patient strategies that can be effective.

Nursing not only allows the patient to autonomously manage symptoms, but also helps to provide a feeling of security and tranquillity regarding their situation [35].

At the same time, the nurse is actively engaged in the education of family members, so that they can acquire the skills and competences necessary to offer the appropriate support to the patient [36,37]. In addition, the nurse provides information on the resources available in the community, such as support groups, to expand the usable support network, in order to support the patient and their family during the course of the disease. This significantly contributes to preventing the patient and their loved ones from feeling isolated during this delicate phase [38]. However, nursing care is not only limited to alleviating physical suffering; in fact, the role of the nurse at this critical moment is crucial and goes far beyond the simple monitoring of physical symptoms. They offer constant and comprehensive support to both the patient and their family members, improving quality of life until the last moment. The main objective is to face the evolution of the disease in the most comfortable, reassuring and respectful way possible, and to facilitate a smooth transition towards the end of life that allows the patient to manage their condition with dignity and peace of mind [10,28,33].

Limitations of the study

This review has some limitations, which hinder its applicability in the context of the Italian health system. First, the limited number of databases consulted may have reduced the amount of articles identified, potentially excluding relevant information. The choice of inclusion criteria, although targeted, excluded studies relating to palliative care delivered at the outpatient and hospice level, focusing exclusively on home care. This approach, while guaranteeing a precise focus, on the other hand limits the completeness of the data collected and loses useful knowledge, excluding a broader vision of palliative care.

. Some of the studies included in the review [26-28] had unrepresentative or small samples of participants, which could influence the generalisability of the results.

Implications for clinical practice

The review suggests that palliative home care may be useful for patients with terminal cancer. In particular, the review highlights the benefits that could be derived from the use of palliative home care in promoting the psychological well-being of cancer patients and enabling terminal patients to spend their last days in the comfort of their own home environment, as desired by them. In fact, in order to apply the results of the review, it is essential to implement palliative home care programmes and services that reduce the use of hospital facilities. Adequate human resources must be provided, suitably trained in palliative home care. The health personnel involved in the treatment, in fact, must have advanced skills in pain management, symptom control and coordination of health and social services. This approach not only aims to improve the quality of life of the patient through a more effective control of symptoms, but also to offer fundamental emotional and social support during the advanced stages of a disease. The continuity of home care allows to establish relationships of trust between the patient, family members and the medical team, facilitating a more personalised and human-centred management of care.

Another crucial point concerns the careful monitoring of symptoms. Implementing specific protocols for the assessment and management of symptoms allows treatment to be adapted in a timely manner to the individual needs of the patient, ensuring optimal comfort and improving quality of life even in the most delicate phases. However, it is also essential to consider the economic aspect of palliative home care, therefore, studies dealing with the continuous and accurate cost-benefit assessment are required to balance the clinical effectiveness with the economic sustainability of such interventions.

CONCLUSIONS

The objective of the study was to describe the knowledge related to the clinical, emotional and economic impact of palliative home care in cancer patients. The review conducted suggests that palliative home care is a crucial element in the care of the terminally ill cancer patient, fundamental to ensuring adequate end-of-life management.

Our review shows that home care offers essential psychological support, enabling patients to feel understood and listened to with regard to their needs and requirements. However, some discrepancies have emerged, particularly with regard to the effectiveness of PC in terms of symptom control and reduction of economic costs, therefore, it is hoped that more field studies will be carried out in order to provide a broader and more detailed picture of the effectiveness of palliative care in these areas.

FUNDING STATEMENT

This research received no external funding.

CONFLICT OF INTEREST

The authors report no conflict of interest.

AUTHORS' CONTRIBUTION

All authors contributed equally.
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Transformational Leadership: the key to reducing Intention to Leave In nurses

Gianluca Azzellino ¹*, Massimo Bordoni²

1 Department of Territorial Assistance, Local Health Authority (AUSL 04) of Teramo, Italy

2 Department of Social Health. Local Health Authority (AUSL 04) of Teramo, Italy

Corresponding author: Gianluca Azzellino, Department of Social Health. Local Health Authority (AUSL 04) of Teramo, Via Finlandia n. 7/1,65015 Montesilvano, Italy

Email: gianluca.azzellino@aslteramo.it

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ABSTRACT

This commentary responds to the recently published article on transformational leadership in the healthcare context. The article explores how transformational leadership can significantly improve efficiency and job satisfaction in nursing teams. Specifically, it highlights the crucial role of this leadership style in fostering a positive work environment and reducing intentions to leave the profession among nurses. At a time of profound crisis for the nursing profession, characterised by staff shortages, increased workload and high rates of abandonment of the profession, transformational leadership could represent an effective model to address these challenges. This leadership approach, based on vision, inspiration, and involvement, can strengthen nurses' motivation and satisfaction by promoting a positive and stimulating working environment. The analysis emphasises the importance of adopting innovative management practices to address current challenges in the healthcare sector, providing a basis for further research and practical implementation.

Keywords: Nursing leadership, Burnout, intention to leave, professional development, nurse education, job satisfaction

INTRODUCTION

The authors read with interest the article by Rizzo et al. (2024) entitled “Transformative leadership and job satisfaction in the nursing profession: A narrative review”. The article offers an in-depth analysis of the effect of transformative leadership on the nursing profession. The authors explore how this leadership style not only positively influences nurses’ job satisfaction, but also their intention to leave the profession. This is particularly relevant in a global context in which the nursing shortage is a critical challenge for healthcare systems. However, the increasing complexity of the healthcare system, coupled with the new challenges posed by the global pandemic, has made the need for an evolution in the nursing leadership model evident. This commentary aims to further explore the findings of Rizzo et al. by contextualizing their study within the current issues facing the nursing profession and discussing the importance of implementing transformative leadership strategies to improve both the quality of healthcare and the intention to stay. Our analysis through a combination of direct experience in the field and critical review of relevant literature, proposes to offer an in-depth perspective on how transformational leadership can be implemented effectively to address current challenges in nursing.

DISCUSSION

It was interesting to read the research work by Rizzo et al. (2024) on the relationship between transformational leadership and job satisfaction. At a time when the healthcare sector is facing unprecedented challenges, stability and satisfaction of nurses have become crucial priorities. Transformational nurse leaders can recognise and anticipate the needs of their nursing staff by establishing a good rapport and making significant efforts to meet their needs to encourage a sense of empowerment and autonomy that can subsequently translate into job satisfaction [1]. Recent studies have shown that nurses working under the guidance of transformational leaders tend to show greater attachment to their role and to the organisation. This results in fewer people leaving the profession, thus reducing turnover and the costs associated with training and induction of new staff. Transformational leadership, defined by Bass as a leadership style that inspires and motivates employees through shared vision, effective communication, individualised attention, and intellectual stimulation, stands out as a leadership model capable of fostering a positive and motivating work environment [2]. A leadership style that promotes autonomy, support and empowerment of nurses can improve job satisfaction, organisational commitment, and nurses' intention to remain in their position by reducing emotional exhaustion [3]. As Rizzo et al. points out, there is therefore a need to identify and fill current gaps in nursing leader competencies and skills through processes of two-way communication and mutual trust between managers and nurses. Cummings et al. conducted a systematic review that showed that transformational leadership behaviour is positively correlated with job satisfaction [4]. Strengthening the sense of belonging and personal fulfilment can reduce burnout and the intention to leave the profession. In an environment where nurses feel valued and supported, they are more likely to remain committed and motivated in their work. Overall, studies support the fact that having positive support factors and working relationships in place, including positive relationships with physicians, leader support, positive leadership style and teamwork, can play a protective role against Burnout [5]. Another positive aspect of this style is its ability to motivate professionals to overcome daily challenges and actively engage in their work. Leaders who display transformational behaviour can inspire staff to see their work as a meaningful mission, rather than just an occupation. Kanste highlighted how transformational leaders are able to foster a sense of purpose among nurses, encouraging them to contribute beyond basic expectations [6]. This increased motivation can result in a reduction in the intention to leave the profession. A cohesive environment can improve the quality of care and increase job satisfaction. Boamah et al. showed how transformational leadership fosters the creation of cohesive and collaborative teams, thus improving outcomes for both patients and nurses. This team cohesion can reduce feelings of isolation and increase the sense of support among staff [7]. Professional development programmes that focus on transformational leadership skills can prepare nurse leaders to lead their teams effectively. It is therefore crucial to invest in the training of leaders capable of adopting this leadership style in order to build motivated and resilient teams. Despite the fact that a transformational leadership style is correlated with better job satisfaction, existing evidence shows that it is rarely used by nursing leaders in healthcare settings [8]. Furthermore, fostering a culture of continuous feedback and professional growth can help leaders develop and maintain transformational behaviours. Secondly, it is crucial to promote policies that foster work-life balance, the creation of open and transparent communication channels, and the recognition and valuing of nurses' contributions. The choice of the best leadership style could be one of the modifiable factors that a healthcare organisation can adopt to create a favourable working environment and promote quality care [9]. Rizzo et al. correctly identified the increasing pressures on nurses and the need for innovative strategies to address the problem. However, we believe that an emphasis on transformational leadership can offer a sustainable solution and practice. The scientific community and policy makers need to seriously consider adopting this leadership model as part of strategies to address the professional crisis. Transformational leadership offers a promising perspective to improve job satisfaction, reduce burnout and intent to leave, and thus contribute to building a more attractive and sustainable healthcare system.

Conflict of interest

The authors declare no competing interests

Financing

No funding to declare

Author contributions

All authors contributed equally to the work

REFERENCES

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Jr, Morgan. (2006). Leadership and performance beyond expectations, by Bernard M. Bass. New York: The Free Press, 1985, 191 pp. $26.50. Human Resource Management. 25. 481 - 484. 10.1002/hrm.3930250310.
Laschinger HK, Wong CA, Cummings GG, Grau AL. Resonant leadership and workplace empowerment: the value of positive organizational cultures in reducing workplace incivility. Nurs Econ. 2014 Jan-Feb;32(1):5- 15, 44; quiz 16. PMID: 24689153.
Cummings GG, Tate K, Lee S, Wong CA, Paananen T, Micaroni SPM, Chatterjee GE. Leadership styles and outcome patterns for the nursing workforce and work environment: A systematic review. Int J Nurs Stud. 2018 Sep;85:19-60. doi: 10.1016/j.ijnurstu.2018.04.016. Epub 2018 May 3. PMID: 29807190.
Dall’Ora C, Ball J, Reinius M, Griffiths P. Burnout in nursing: a theoretical review. Hum Resour Health. 2020 Jun 5;18(1):41. doi: 10.1186/s12960-020-00469-9. PMID: 32503559; PMCID: PMC7273381.
Kanste, Outi. (2008). The Association between Leadership Behaviour and Burnout among Nursing Personnel in Health Care. Nordic Journal of Nursing Research. 28. 4-8. 10.1177/010740830802800302.
Boamah SA, Spence Laschinger HK, Wong C, Clarke S. Effect of transformational leadership on job satisfaction and patient safety outcomes. Nurs Outlook. 2018 Mar-Apr;66(2):180-189. doi: 10.1016/j.outlook.2017.10.004. Epub 2017 Nov 23. PMID: 29174629.
Morsiani G, Bagnasco A, Sasso L. How staff nurses perceive the impact of nurse managers' leadership style in terms of job satisfaction: a mixed method study. J Nurs Manag. 2017 Mar;25(2):119-128. doi: 10.1111/jonm.12448. Epub 2016 Dec 5. PMID: 27917561.
Phillips LA, de Los Santos N, Jackson J. Licensed practical nurses' perceptions of their work environments and their intentions to stay: A cross-sectional study of four practice settings. Nurs Open. 2021 Nov;8(6):3299-3305. doi: 10.1002/nop2.1046. Epub 2021 Aug 25. PMID: 34432374; PMCID: PMC8510757.

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Monitoring of toxicities induced by Chimeric Antigen Receptor T-cell therapy: Protocol for a phenomenological study on the experiences of nurses

Valentina Simonetti ^1†, Letizia Governatori ^2†, Francesco Galli ³, Cesare Tozzi ⁴, Romano Natalini ⁴, Andrea Toccaceli ⁵, Francesco Pastore⁶, Giancarlo Cicolini ¹ & Dania Comparcini ⁷*

Department of Innovative Technologies in Medicine and Dentistry, “G. d 'Annunzio” University of Chieti-Pescara, Chieti, Italy; v.simonetti@unich.it; https://orcid.org/0000-0002-7185-4850 (VS); g.cicolini@unich.it; https://orcid.org/0000-0002-2736-1792 (GC).
Department of General and Specialist Surgery, Adult and Pediatric Orthopaedics Clinic, University Hospital "Azienda Ospedaliero Universitaria Delle Marche", Ancona, Italy; letizia.governatori@ospedaliriuniti.marche.it (LG).
Faculty of Medicine and Surgery, Polytechnic University of Marche, Ancona, Italy; galli.francesco77@gmail.com; https://orcid.org/0009-0000-3550-1268 (FG).
Department of Internal Medicine, Haematology Clinic, PICC Unit, University Hospital "Azienda Ospedaliero Universitaria Delle Marche", Ancona, Italy; tozzicesare1973@gmail.com (CT); romano.natalini@ospedaliriuniti.marche.it. (RN).
Nursing Department, University Hospital "Azienda Ospedaliero Universitaria Delle Marche", Ancona, Italy; andrea.toccaceli@ospedaliriuniti.marche.it (AT).
Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome, Italy; francesco.pastore@uniba.it (FP).
Interdisciplinary Department of Medicine, “Aldo Moro” University of Bari, Bari, Italy; dania.comparcini@uniba.it; https://orcid.org/0000-0003-3622-6370 (DC).

^† The authors LG and VS contributed to the study in equal measure.

* Corresponding author: Dania COMPARCINI (DC), PhD, MSc, RN, research fellow. Interdisciplinary Department of Medicine, “Aldo Moro” University of Bari, Italy; email: dania.comparcini@uniba.it; https://orcid.org/0000-0003-3622-6370.

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ABSTRACT

Introduction: Chimeric Antigen Receptor T-cell therapy (CAR-T) represents the most recent immunotherapy’s innovation to cure some refractory and/or relapsing haematological tumours.

However, because of the life-threatening toxicities it might cause such as Cytokine Release Syndrome and Immune Cell Associated Neurotoxicity Syndrome, patients are closely monitored by nurses for the early identification of toxicities during the post-infusion phase of CAR-T cell therapy. Exploring the nurses’ experience with respect to any difficulties related to the monitoring is important since these issues can be perceived by patients and affect the nurse-patient’s caring relationship, considered as a shared lived experience between the patient and the nurse.

Aim: This study aims to investigate haematology nurses’ lived experience with monitoring CAR-T’s induced toxicities.

Materials and methods: A qualitative study following Cohen's phenomenological methodology will be conducted through semi-structured interviews in a sample of Italian nurses working in haematology units, who have had previous experience in the management of patients undergoing CAR-T therapy for at least two months and who have performed the monitoring for the same months of experience; the interviews will be audio-recorded and then transcribed verbatim. Two researchers will carry out the manual analysis and interpretation of the collected data independently, identifying themes and sub-themes.

Conclusion: To explore the nurses’ experiences in this field could facilitate the identification of the educational needs, at individual and group level. Despite it is important to consider contextual variables, the findings of this study could contribute to develop evidence supporting advanced and specialized nursing care in the haematological setting.

Keywords: hematology, nursing, CAR-T therapy, phenomenological, qualitative.

INTRODUCTION

Chimeric Antigen Receptor T-cell (CAR-T) therapy is the latest immunotherapy approach for the treatment of certain resistant or relapsing haematological cancers [1], including: Acute Lymphoblastic Leukaemia, diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and mantle cell lymphoma. However, despite being designed to act selectively in eliciting a targeted immune response against neoplastic cells, anti-CD19 CAR-T cell therapy is not free of risks and even serious side effects. The most frequent toxicities are Cytokine Release Syndrome (CRS), reported in 57% to 93% of patients who underwent CAR-T [2], and Immune Effector Cells Associated Neurotoxicity Syndrome (ICANS), which occurs in 20% to 70 % of patients [3]. Nevertheless, while they are often manageable and reversible, they can prove fatal, requiring close patient monitoring, early recognition of toxicities, and prompt intervention to reduce morbidity and mortality [3].

To achieve this, patients are closely monitored by nurses after infusions following specific protocols and procedures adopted in the operating units. More specifically, monitoring by nurses includes the assessment of vital parameters as well as typical signs and symptoms of Cytokine Release Syndrome (CRS) and neurological toxicity (ICANS) [4]. Specifically, to facilitate the identification of early manifestations of neurotoxicity, close monitoring using validated nursing instruments [5] is necessary, including the handwriting test and the quantification of the “ICE - Immune Effector Cell-associated Encephalopathy score”. The latter enables the mental status of patients to be assessed by identifying four ICANS grades (numbered 1 to 4) according to the presence or absence of consciousness impairment, seizures, motor alterations and symptoms of high intracranial pressure [6].

Thus, monitoring enables the nurse to conduct a targeted assessment of the patient's condition in the post-infusion phase, which is decisive for a timely approach to CAR-T toxicities by activating the entire multidisciplinary team. Said approach effectively relies on the meticulous execution of the objective examination, where a high patient assessment frequency [7] enables the practitioner to perceive even the most subtle changes in the patient's psycho-physical condition.

A recent study showed that for patients undergoing CAR-T cell therapy and experiencing significant side effects, continuous monitoring by nurses provides them with a sense of security, and they particularly appreciate the time nurses devote (in addition to monitoring activity) to engaging in dialogue and expressing an interest in their state of health [8]. Therefore, it is essential to acquire deeper insights into the challenges nurses face during the complication monitoring phase, considering that patients may sense such difficulties, which may, consequently, affect the caring relationship established during this crucial assistance.

As a fundamental aspect of nursing practice, the nurse-patient relationship is part of a broader context in which nurses use their senses, knowledge, and experience to exercise professional judgment and discernment when providing care in specific situations [9]. As such, a thorough examination of patients' care experience and the related outcomes must also be conducted with due consideration for the experiences narrated by the haematology nursing staff, since the practice of nursing care necessarily implies a shared experience of the relevant dynamics [10,11].

However, the topic of nursing care in the management of patients undergoing CAR-T cell therapy is a relatively new area of investigation, so few studies have been conducted in the field of nursing. The limited literature has only investigated the experience of patients undergoing CAR-T therapy and/or their caregivers without delving into the experience itself and the meaning attributed to this experience by those who care for patients and/or interact with and support caregivers [12-14]. Moreover, only one study, conducted in China, investigated the experience of a group of oncology nurses in managing this specific subpopulation of patients but was focused on nursing competence [15]. This study did not examine the nurse's key role during the toxicity monitoring phase in-depth, and the main focus was on aspects related to nursing skills rather than the significance of the experience.

To date, to the best of our knowledge, no study has explored nurses' experiences in the monitoring and care of this specific category of haematological patients, even though the aforementioned scientific literature frequently emphasises the importance of nursing care at all stages of the clinical care process and particularly during the post-infusion phase.

Study aim

The purpose of this study is to explore the experience of nurses caring for haematology patients during the monitoring of the main toxicities associated with CAR-T therapy.

MATERIALS AND METHODS

Study design

A hermeneutical phenomenological study will be conducted according to Cohen’s method [16]. A summary of the planned operating times for the study is shown in Table 1.

Study phases	Activities	Estimated duration (time)	Follow-up
Definition and planning	Review and analysis of the literature, research question	1 month (September)	Focus: researchers; stakeholders.
	Development of the research design, context analysis, selection of potential data acquisition centres	2 months (October–November)
	Drawing up of draft protocol	2 months (December–January)
	Review and finalisation of the protocol.	2 months (February–March)
	Authorisations by the participating centres. Request for an opinion form the Ethics Committee (EC)	2 months and 15 days (April–June)
	“Bracketing” process and exchanges between researchers	15 days (June)
2. Recruitment of participants	Recruitment of data acquisition centre and participants	15 days (July)	Focus: participants
	Finalisation of the sampling plan
	Informed consent
Data collection	Pre-test data collection tool (pilot interviews) and finalisation of interview questions	15 days (July)
Data collection	Conduct of interviews and return of transcripts	1 month (August–September)
Data analysis	Data preparation: transcription, reading of interviews (units of meaning)#	1 month (September–October)	Focus: texts (transcribed interviews)
	Data codification and reduction process
	Thematic analysis
	Writing and editing
	Discussion and sharing of emerging themes (provisional)	15 days (October)	Focus: researchers, participants
Final report	Drafting of the final report, manuscript.	1 month (November)	Focus: scientific community, stakeholders

Table 1. Envisaged timeline for the study (2023–2024).

The phenomenological approach is based on the understanding of questions of meaning and the actual experiences of informants [16] by combining the methodological properties of descriptive (Husserlian) and interpretative (Gadmerian) phenomenology. The former descriptive scope aims to describe the experiences of individual members of the cohort under study after a preliminary phase in which the researchers set aside prejudices and preconceptions about the phenomenon under investigation (“bracketing”). This is crucial to reduce the influence of such prejudices and preconceptions on the subsequent phase, in which the themes and data emerging from the interviews are respectively extrapolated and analysed. The interpretative intent, on the other hand, examines and interprets the reported experiences in depth [17]. Therefore, since this methodological approach focuses on understanding questions of meaning and the real-life experiences of the respondents [16], it is particularly suited to nursing-related research and topics seldom explored in the literature. It is also instrumental in the broader context of a working organisation for identifying perceived needs and the solutions that can best address them [16].

Participants and study context

The participating cohort will be recruited from haematology operating units in Italy, identified at the national level among the accredited haematology and onco-haematology centres of advanced specialisation for the treatment of leukaemias and lymphomas, compliant with specific requirements and authorisations for cell therapies as prescribed by AIFA, the Italian Medicines Agency.

Intentional (“propositional”) sampling will be carried out within each data collection centre according to a homogeneity criterion [18,19] to investigate differences and variations within a relatively homogeneous sample [18, 20] in relation to experience in handling the monitoring cards of patients subject to complications associated with CAR-T therapy. This sampling will enable the researchers to deliberately select a cohort of nurses who possess specific expertise and experience in the management of complication monitoring based on a set of pre-established criteria (inclusion and exclusion criteria); this is of fundamental importance in order to obtain a sample capable of providing meaningful, subject-specific information as well as credible and reliable explanations of the phenomenon under study, irrespective of the cohort size [21].

Sampling will continue until data saturation is reached, understood as a process of conducting interviews sequentially until the concepts expressed by the respondents are repeated several times without introducing new concepts or themes [22]. The unitary element of analysis will coincide with the experience under study; therefore, considering that a single respondent can generate many concepts, large samples in numerical terms are not necessarily useful for generating a comprehensive dataset with respect to the purpose of the study and the phenomenon of interest [23]. Indeed, in a qualitative dataset, most new information is generated early in the process and generally follows an asymptotic curve whereby new information declines after a small number of interviews or data analyses [24]. In particular, with regard to studies marked by a high level of population homogeneity, the literature indicates that a sample of six interviews is sufficient to foster the development of meaningful themes and useful interpretations related to the phenomenon under study [25]. Therefore, in accordance with the above and considering that the scope of phenomenology is to explore the common features of real-life experiences gleaned from data provided by only a few individuals who have experienced a particular phenomenon as subjects capable of providing detailed and in-depth information [23], in accordance with claims stated in the literature regarding sample sizes for phenomenological studies, which generally vary from 5 to 25 respondents [26], a sample cohort of 6 to 12 nurses is deemed acceptable for this study.

Inclusion and exclusion criteria

Subject to voluntarily agreeing to participate in the study by signing the informed consent, the study will include all nurses who provide direct patient care at the data collection centres and who have passed the probationary period within the organisation for the inclusion of newly recruited or newly assigned nurses in the operating unit. The selected nurses will have had appreciable experience (for a minimum of two months) in managing patients undergoing CAR-T therapy and must be practised in the use of assessment tools (at least on one occasion) during the same months of experience.

Nurses who provide day hospital care at the operating unit and those in exclusively organisational roles will be excluded from the study.

Data collection tools and study procedures

Interview

For data collection, we developed a draft semi-structured interview outline with open-ended questions that will allow participants to express themselves freely [16]. The interview outline was drawn up considering previous similar studies carried out in the haematology field [12-15] and following discussion within the research group and discussion with expert haematology clinicians working in an accredited Italian haematology and oncohaematology centre with high specialisation in the treatment of leukaemias and lymphomas, meeting specific requirements and authorisations for cell therapies.

The envisaged main questions are as follows: “Please could you tell us about your experience with monitoring CAR-T therapy-induced toxicities for patients in the Haematology Unit?; “How would you describe your experience using CRS and neurological toxicity monitoring tools such as the ICE score and the handwriting test?”; “Regarding your experience, what were the positive and negative aspects? Can you please provide some examples?”. If further investigation of the emerging themes is required, the researcher will add specific questions to the interview to clarify the contents expressed. Finally, the interview will conclude by asking participants if they need to add anything else or report anything specific to what has already been said. This will be solicited by the following question: “Do you have any further comments or suggestions?”; in the event of a negative response, the interview will be considered completed.

In addition, demographic data will be collected from participants relating to age, gender, level of education, marital status, years of work as a nurse, years of work as a nurse in the current haematology unit, previous clinical experience (work areas/clinical specialities in which you have served as a nurse).

Once the necessary ethical authorisations for study commencement have been obtained, a limited number of pilot interviews (at least two) will be conducted to test the draft interview outline and possibly fine-tune it before proceeding with the study.

Data collection

In keeping with the method proposed by Cohen and co-authors [16], before conducting the interviews, all researchers will undertake a process aimed at suspending, i.e. bracketing their personal expectation bias, assumptions, and preconceptions, if any, regarding the phenomenon being studied. According to the proposed method, this approach is crucial as it reduces the likelihood of the researcher's judgements influencing the extrapolation of themes from the interviews [16].

Each interview will be conducted face-to-face, individually, by a researcher with professional experience in the field of haematology, but who is not part of the team working in the data collection centre. In addition, interviews will be conducted by prior agreement with the individual participant in a location that ensures participants feel comfortable, facilitating spontaneous and natural responses [16].

Subject to written informed consent, each interview will be recorded using protected digital tools that are not accessible except to researchers so that they can subsequently be transcribed verbatim for data analysis purposes. Subsequently, the transcripts will be returned to the interviewees for comments or clarification. Considering the impossibility of establishing a predetermined interview duration, given the purpose of the study and the complexity of the phenomenon to be examined, a time of between 40 and 70 minutes is envisaged for each interview.

Data analysis

Two researchers will independently analyse the data extracted from the interviews using a manual approach [27,28]. In accordance with the method of Cohen and co-authors [16], the data analysis will comprise the following principal phases: (I) The Data Preparation Phase, in which the interviews, previously recorded, will be transcribed verbatim and transferred to digital media; in this phase, the units of analysis (words, phrases or themes) will be selected, and a repeated and in-depth reading of the transcripts will be carried out, through the process of immersion in the data [29] to become familiar with the transcripts and highlight the essential features within each interview [30,31] while simultaneously carrying out an initial interpretation of the contents that will guide the codification of the data in the subsequent analysis phases [16]. (II) the Data Codification and Reduction Process: in this phase, the researchers will reorganise the contents of the interviews, grouping content pertaining to the same subject, eliminating any digressions that stray from the phenomenon under study and simplifying the respondents' spoken language without actually modifying the content expressed; a “line by line” analysis of what the participants reported will be carried out to provide “a label of meaning” to each part of the text [16], starting the reduction process while maintaining the overall essence of the contents expressed [16]. (III) Thematic Analysis: the purpose of the thematic analysis is to systematically describe and interpret the meaning of the qualitative data generated by the interviews, generating themes that will be finally analysed and presented [32]. At this stage, once an overall interpretation of the contents has been obtained, sentences in the text will be underlined by writing “headings” in the margin of the text that will represent the provisional names and/or themes assigned to the most salient content aspects [16,33-36]. To this end, colours may be used, or specific text segments may be highlighted to indicate potential interpretative patterns instrumental to identifying data segments; similarly labelled interview passages will then be grouped and appropriately reorganised [16]. In this way, as the main headings are identified, the extracted data will be collected and grouped manually within each codification, generating an initially unrestricted list of categories [36]. (IV) The Writing and Editing Process [35]: a reflexive writing and rewriting process will initially identify themes that will be followed by an in-depth examination and comparative analysis of the same within a broader framework to validate the overall meaning derived from the contents of the interviews [16]. The lists of categories will then be grouped into higher-order headings of broader scope capable of describing and augmenting the understanding of the phenomenon, thereby generating new knowledge [36]. The category reduction process will involve pooling similar or related observations and comparing data from within the same category with data from other categories [36]. Finally, the abstraction process will make it possible to formulate a general description of the phenomenon under study by formulating specific categories (general and subcategories) that will be named using words that reference their content [29]. A deep probing of the meaning of the interview content will lead to an overall understanding of the respondents’ real-life experiences as expressed within the emergent themes. This understanding will be supported by recourse to margin notes as part of the hermeneutic process underlying the transformation of the text fields into a coherent narrative [16,37]. (V) Following thematic analysis, the researchers will discuss the provisional emergent themes with the other members of the research team, including qualitative research and haematology nursing experts. Subsequently, the provisional themes will be returned to the participants to verify that the researchers had correctly interpreted their submissions, and only then will they be confirmed.

Methodological rigour

To minimise social desirability bias, the interviews will be conducted by a researcher who has no previous involvement with the study centre in a professional capacity. The researchers tasked with analysing the data will also have previous oncological work experience, albeit in different settings other than the data collection centre; this will underpin the credibility of the research process. The practice of “bracketing” will promote critical thinking among researchers to ensure methodological rigour and avoid the contamination of individual judgement during data analysis [16]. The practice of “bracketing” will promote critical thinking among researchers, ensuring methodological rigour and avoiding the contamination of individual judgement during data analysis [16]. Furthermore, to reinforce the collaborative relationship between participants and researchers and confirm the accuracy of outcomes, respondents will be asked to provide feedback on the (provisional) themes identified (member-checking of participants); they will also be offered the opportunity to add details or clarifications regarding their experience, if necessary [38].

Ethical considerations and protection of data confidentiality

The study was submitted to an independent Ethics Committee, which expressed a favourable opinion on the conduct of the study (Project identification code 1697/CEL – CARTINF Study; approval number 389|13/06/2024).

Nurses' involvement in the survey will be voluntarily, and the semi-structured interviews will be preceded by asking study participants for written consent to their participation, recording of the interviews, and processing of related data. They will also receive all information about the study's purpose, how data is collected and managed, and its confidentiality.

Anonymity will be guaranteed as prescribed by prevailing legislation on the processing of personal data and respect for privacy (Italian Laws nos. 675 & 676 of 31 December 1996, Official Journal of 08/01/1997, Article 7 of Italian Legislative Decree no. 196 of 30 June 2003 and European Privacy Regulation EU 2016/679, General Data Protection Regulation – GDPR). Relevant data will be strictly used for the purposes of the study.

Presentation of results

The results of the study will be presented in narrative form, reporting excerpts from interviews in support of the identified themes and sub-themes. Furthermore, graphic aids in the form of charts and tables will be included to enhance visualisation of the interview outcomes and related analyses (e.g. with respect to the originally codified themes) in terms of response frequencies and percentages [32]. In particular, tables may be used to express thematic outcomes quantitatively (e.g. organisation of the various themes according to the number of codes they contain), the intent being to facilitate and not replace the presentation of the interview extracts in narrative form.

DISCUSSION

To date, the real-life experiences of nurses responsible for monitoring CAR-T therapy toxicity have not been significantly studied or reported in the literature. No such research has been undertaken in Italy, while, at an international level, only a recent study conducted in China investigated the views of nurses caring for this patient category to assess the skills and knowledge required for the specific care context [15]. Yet, given the broader scope of contextual acquired knowledge, close investigation into the aspects of the nursing experience with respect to one of the salient aspects of caring for this patient segment is of paramount importance. Such aspects manifestly impact clinical practice and enrich caring skills, not only in terms of scientific knowledge, but also in relation to intrinsic, humanistic, relational and affective aptitudes [39-42]. Indeed, nurses also expand and refine their knowledge over time by elaborating their clinical practice experiences [43]; in this sense, the findings of this study could be beneficial in understanding how experience, not only educational but also clinical, can provide benchmarks for adapting and refining onco-haematology nursing care concerning the delicate and complex phase of complication monitoring in patients undergoing CAR-T cell therapy. As highlighted in the literature, in fact, the cumulative process of structuring and drawing on real-life experience engenders a body of knowledge that represents a resource for interpreting past and present experiences and, at the same time, anticipating and supporting the shaping of future experiences [43]. Ultimately, with regard to the nursing skills specific to these care contexts, the study findings may provide useful information for the development of advanced skills aimed at implementing clinical practice improvement projects. The latter would strive to optimise care time using appropriate and effective documentation, enriching the effort dedicated to a caring relationship with patients that ensures optimal quality of care and clinical safety. Moreover, appreciation of the meanings attributed to individual experiences may enhance the crucial role of haematology nurses in the management and monitoring of treatment-related toxicity, which is acknowledged as an influential factor in the overall patient experience and related care outcomes [44]. Reflecting on the advanced expertise of affirmed professionals working in multidisciplinary teams as well as on individual and group needs may increase professionals' awareness of the importance of sharing their real-life experiences. Accordingly, the methodology devised for this study and its findings may serve to develop organisational strategies aimed at effective professional training in contexts involving the introduction of specific nursing activities instrumental to the introduction of new clinical procedures and protocols. Indeed, there is a need to invest in nursing leadership and governance in order to promote further empowerment of the role of the function and to respond to the need for strong nursing standards [45] in oncohaematology practice. Lastly, the findings of this study may also stimulate thinking within the universities since, in order to invest in university education that produces advanced nursing expertise within multidisciplinary teams, it is essential that curricula are appropriately aligned with health priorities and emerging issues, both from a global and national perspective [46].

CONCLUSIONS

The introduction of innovative and complex procedures necessitates the development of healthcare and educational strategies that support the advancement and recognition of nursing expertise in specific care settings. Thus, building on the individual insights of each participant, the findings of this study may reveal hitherto unknown aspects of haematology nursing and contribute to the recent debate on advanced nursing skills by providing a detailed understanding of the experiences of nurses in haematology care.

Limitations of the study

The study may entail some limitations; the results may be affected by contextual organisational variables, which are difficult to generalise to all clinical scenarios, although they are easily transferable to a variety of contexts, also considering that the centres approved for the administration of CAR-T cell therapy meet the same national standards defined by AIFA. Nonetheless, to further ensure the credibility and transferability of the results to other organisational contexts, nurses should be selected from several approved centres throughout Italy. In addition, given the subject matter, some interviewees might place undue emphasis on the positive aspects of direct patient care while more readily identifying critical organisational factors, which do not directly impact their role identity as individuals and professional team members to the same extent.

Funding

This research did not receive any specific funding from funding bodies in the public, commercial or non-profit sectors.

Conflicts of interest

None.

Authors’ contributions

Concept and methodology: VS, LG, DC, GC; preparation and drawing up of the original manuscript draft: VS, LG, DC; supervision: GC, DC; methodology; writing, revision, and editing: LG, FG, CT, RN, AT, FP. All authors contributed to the finalisation of the study protocol and approved the final manuscript.

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Mentorship effect on healthcare providers' adherence to postpartum haemorrhage guidelines and maternal outcomes in Rwanda. A quasi-experimental study

Benjamin David Habikigeni ¹, Arlette Bizimana ², Maxwell Mhlanga ^3*, Tsion Yohannes ⁴

^1;2;3;4Centre of Gender Equity, University of Global Health Equity, Kigali, Rwanda

* Corresponding Author: Maxwell Mhlanga Centre of Gender Equity, University of Global Health Equity, Kigali, Rwanda

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ABSTRACT

Background: Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide. Effective management of PPH heavily relies on adherence to clinical guidelines. Mentorship programs aim to enhance healthcare providers' (HCPs) knowledge, skills, and guideline adherence, but their impact on guideline adherence needs evaluation.

Objective: To evaluate the effect of a clinical mentorship program on HCPs' adherence to PPH clinical guidelines and patient outcomes at Muhima District Hospital (DH) and its associated health centers (HCs).

Methods: A quasi-experimental design was used to compare HCPs' adherence to clinical guidelines before and after mentorship. Maternal outcomes were also analyzed in relation to guideline adherence. Standardized medical records provided data, and consecutive sampling included cases sequentially from medical registers. The Wilcoxon test was used to assess the effect of mentorship on adherence to guidelines. Multivariate regression analysis was performed to explore the relationship between mentorship, guideline adherence, and maternal outcomes.

Results: The study included 384 women with PPH. Adherence to clinical guidelines before (96.4%) and after (95.8%) the mentorship program showed no significant change (P-value = 0.25). However, adherence to guidelines was significantly associated with better maternal outcomes (P-value < 0.001). Multivariate logistic regression indicated significantly lower odds of no complications in cases where guidelines were not followed. Adherence to guidelines (AOR = 0.061, 95% CI: 0.001- 0.026), prolonged labor (AOR = 187.25, 95% CI: 13.07- 2683.14), blood loss (AOR = 0.004 95% CI: 0.000 - 0.0008), and specific causes of PPH (AOR = 0.013, 95% CI: 0.000- 0.068) had significant associations with maternal outcomes.

Conclusion: Adherence to clinical guidelines is critical for high-quality care and improved maternal outcomes in PPH cases. The study confirms the positive impact of guideline adherence on maternal outcomes, emphasizing the importance of promoting and strengthening adherence. While the mentorship program supported high adherence rates among HCPs, it alone may not be sufficient to ensure adherence, suggesting the influence of additional factors, such as training from other institutions.

Keywords: Mentorship, Healthcare Providers, Postpartum Hemorrhage, Maternal Outcomes, Clinical Guidelines, Quasi-experimental Study

INTRODUCTION

A woman dies unnecessarily every two minutes due to preventable pregnancy and childbirth-related issues [1]. Though the world saw a remarkable 38% decline in maternal mortality between 2000 and 2017, the death toll continues to be dangerously high [2]. In 2020, the global maternal mortality ratio (MMR) was 223 deaths per 100,000 live births and in Rwanda the mortality rate was 203 deaths per 100 000 live births, with postpartum haemorrhage (PPH) being the primary cause of death [3,4]. PPH is the major contributor to maternal deaths, responsible for 27.1% of maternal deaths worldwide, with 44% of such deaths in the Sub-Saharan Africa region [5] and 22.7% in Rwanda [6]. PPH is excessive bleeding after childbirth, with blood loss of more than 500 millilitres (mL) for a vaginal delivery or 1000 mL for a caesarean section [7]. PPH is categorized as primary when it occurs within 24 hours of birth and secondary when it happens more than 24 hours after delivery up to 12 weeks postpartum [8]. The underestimation of the actual blood loss by healthcare providers was identified as problematic in diagnosing and managing PPH [8]. In addition to the high mortality, PPH is responsible for morbidities such as anaemia, complications from a blood transfusion, and hysterectomy, resulting in the loss of childbearing capacity [9]. Many factors contribute to the adverse outcomes of PPH in developing countries. Those factors comprise low socioeconomic status, limited access to healthcare, shortage of skilled healthcare professionals, and inadequate healthcare manifested by poor adherence to established evidence-based protocols [10]. Regarding the economic aspect, studies report that Women in low-income countries are at higher risk of dying during childbirth, with 1 in 45 deliveries in comparison to 1 in 5400 deliveries in developed countries [4].

In healthcare, evidence has shown that adherence to established guidelines can improve the standard of care and decrease mortality [11]. However, in spite of the availability of guidelines and protocols, adhering to them remains challenging in many developing countries [12].

Regular training and education for healthcare professionals on PPH guidelines and protocols can

help ensure they have the knowledge and skills to provide high-quality care [12]. Mentorship is an effective tool for capacity building of healthcare providers in diagnosing and managing diseases by improving their knowledge, skills, and confidence, resulting in better patient outcomes [13]. Clinical mentorship refers to knowledgeable and experienced healthcare professionals guiding and advising less experienced ones on diagnosing and managing medical conditions in their professional development [14].

The government of Rwanda has invested in training healthcare providers in managing PPH and other obstetric emergencies and has developed guidelines and protocols for managing PPH but there is a gap in information on whether mentorship improves healthcare providers practice [15,16]. This study assessed the impact of a clinical mentorship program on HCPs' adherence to PPH guidelines and maternal outcomes in Muhima District Hospital catchment area.

MATERIALS AND METHODS

Design and setting: A quasi-experimental non-equivalent before-and-after study was conducted in the maternity department of two health centers, Cornum and Rwampara in the Nyarugenge district of Kigali city. Nyarugenge District has the busiest maternity service facilities in Rwanda, with approximately 7000 births per year [17].

Population target: The population consists of women who gave birth and developed PPH in the study locations. The sample was divided into two groups: those assisted by staff without specific training in managing postpartum hemorrhage (pre-intervention) and those by staff after training (post-intervention).

Instrument: Medical records were used to collect socio-demographic (age, residence, health center, and insurance) and clinical data (medical history, physical examination, clinical management). A checklist was used for evaluation at the postopography. The checklist highlighted key areas to assess for adherence to evaluate overall adhere to clinical guidelines The checklist had sections which included PPH prevention measures guidelines, PPH initial management measures and secondary management guidelines. Medical records of women with primary and secondary PH who gave birth in the study locations were included, missing or incomplete medical records or medical history records, physical examination, and clinical management were excluded.

Jhpiego-Rwanda tutoring program:

Jhpiego Rwanda is implementing a clinical mentorship program using a model called ‘Low Dose High Frequency’. Low Dose High Frequency (LDHF) enhances clinical abilities by conducting brief and focused simulation-based learning sessions [18]. The project was implemented in seven district hospitals and 129 health centers, where two to four nurses and midwives per health center were selected to participate in the program. The training was conducted from January 2021 to April 2021. The training methods include one-on-one case management observation, analysis of patient monitoring data, discussions on clinical cases, bedside training, and clinical team meetings. One of the mentorship program’s focuses is managing postpartum hemorrhage. The training sessions were given initially and were reinforced by monthly visits and evaluations by mentors in clinical settings to maximize the retention of knowledge and skills. The mentorship program is part of the Barame Maternal, Neonatal, and Child Health (MNCH) Project, funded by Enabel, the Belgium cooperation, and was initiated in December 2020 [19] and is meant to increase the competencies of nurses and midwives in adhering to clinical guidelines of PPH resulting in better maternal outcomes.

Measure(s)

The healthcare providers’ adherence to clinical guidelines was determined using a checklist, by evaluating the partographs. Each required action performed was given one point. A necessary action not performed was given zero. A total score was calculated and the corresponding percentage. An 80% and above percentage score was considered adherence, whereas a lower percentage was regarded as non-adherence, as 80% or more adherence is required for optimal therapeutic efficacy [20].

Maternal outcomes were extracted from health center registers, and grouped into good outcome, morbidity, and mortality. Mothers who were managed successfully, with no complications were considered to have good outcomes. Patients who had complications such as anemia, hemorrhagic shock, kidney injury, infections, and hysterectomy were classified as having morbidity. Mothers who died due to PPH had mortality as an outcome.

Data collection

Data collection started after approval from the Institutional Review Board (IRB) at the University of Global Health Equity (UGHE) and authorization from the Muhima DH and HCs administrations. We explored the health center registers to find patients who had PPH. For referred patients, their outcomes were found in Muhima DH registers and Health Management Information System (HMIS). Once a list of all patients with PPH was identified, then we audited their medical records to extract their socio-demographic characteristics (age, residence, health center, and insurance), their clinical characteristics (parity, cause of PPH, prolonged labor, estimated blood loss, concurrent illnesses, and referral) and the maternal outcomes. We assessed adherence to the partographs using a checklist. There was no direct contact with patients whose records were selected. The confidentiality and security of the personal information of the participants were respected. The pre-intervention and post-intervention groups were made as similar as possible by choosing them from the same healthcare facility and including the clinical clinics of the women treated by the same healthcare workers before and after the implementation of the mentoring program. The group of women enrolled from 1 December 2018 to 1 December 2020 correspond to the pre-mentoring program sample, those from 1 May 2021 to 1 May 2023 correspond to the women assisted by personnel who have carried out the training (post-mentoring).

Data analysis

Descriptive statistics were used to summarize data in SPSS 26. The socio-demographic characteristics that were considered in this study were age, place of residence, health insurance and the type of health centre basing on the findings from the existing literature on similar studies. Similarly, the clinical characteristics that we considered were parity, causes of PPH, prolonged labour, estimated blood loss, concurrent illness and referrals. The chi-square test or Fisher’s exact test were performed to evaluate significant differences in proportions or percentages between the two groups. Fisher’s exact test was used where the chi-square test was not appropriate. Wilcoxon signed-rank test was used to test the association between adherence status (pre and post) and mentorship status, as well as the association between adherence status and maternal outcomes. We conducted a multivariate logistic regression analysis to examine the association between socio-demographic, clinical factors and maternal outcomes. Adjusted Odds ratio, Confidence Intervals, and p-values were reported. Finally, all tests with p-value (P) < 0.05 were considered significant.

Ethical considerations

The study was approved by the University of Global Health Equity Institutional Review Board (UGHE-IRB/2023/013) and Rwanda Ministry of Health (NHRC/2023/PROT/16).

RESULTS

Socio-demographic characteristics

A total of 384 women of which 192 were in the pre- group and 192 were in the post group were

reviewed in this study. Two hundred and four women (53.1%) were from Cornum Health Center and 180 (46.9%) from Rwampara Health Center (Table 1).

Socio-demographic characteristics

Before mentorship

Frequency (%)

After mentorship

Frequency (%)

Health center

Cornum

Rwampara

102 (53.1%)

90 ( 46.9%)

102 (53.1%)

90 (46.9%)

Age

40-49 years

30-39 years

20-29 years

10-19 years

3 (1.6%)

40 (20.8%)

125 (65.1%)

24 (12.5%)

1 (0.5%)

47 (24.5%)

132 (68.8%)

12 (6.3%)

Residence

Urban

Peri-urban

145 (75.5%)

47 (24.5%)

157 (81.8%)

35 (18.2%)

Insurance

Had insurance

No insurance

188 (97.9%)

4 (2.1%)

186 (96.9%)

6 (3.1%)

Table 1. Socio-demographic characteristics of samples

Clinical characteristics

Regarding clinical characteristics of women with PPH as recorded in medical records, the majority of the women were multiparous. Most patients, (93%) had perineal tears and (97.1%) had blood loss between 500-1000 ml (Table 2).

Clinical characteristics

Before mentorship

Frequency (%)

After mentorship

Frequency (%)

Parity

Primiparity

Multiparity

Grand multiparity

77 (40.1%)

108 (56.3%)

7 (3.6%)

72 (37.5%)

115 (59.9%)

5 (2.6%)

Cause of PPH

Perineal tear

Cervical tear

Uterine atony

Retained placenta

Perineal tear and retained placenta

174 (90.6%)

5 (2.6%)

4 (2.1%)

7 (3.6%)

2 (1%)

183 (95.3%)

0 (0.0%)

5 (2.6%)

4 (2.1%)

0 (0.0%)

Prolonged labor

No

Yes

184 (95.8%)

8 (4.2%)

192 (97.9%)

0 (0.0%)

Estimated

blood loss

>1000 ml

500-1000 ml

6 (3.1%)

186 (96.9%)

5 (2.6%)

187 (97.4%)

Concurrent illness

None

Preeclampsia

191 (99.5%)

1 (0.5%)

192 (100%)

0 (0.0%)

Referred to a

higher level

No

Yes

186 (96.9%)

6 (3.1%)

185 (96.4%)

7 (3.6%)

Table 2. Clinical Characteristics

Healthcare providers’ adherence to clinical guidelines

The Wilcoxon signed-rank test was conducted to determine whether the intervention was had an overall significant effect on adherence to clinical guidelines. The null hypothesis (H_O) states that there is no difference in adherence scores before and after the intervention. With a p-value of 0.25, we fail to reject the null hypothesis at the 0.05 significance level (Table 3). This means there is not enough statistical evidence to conclude that the intervention led to a significant change in adherence to clinical guidelines. The same trend of results was realised at the individual sites which were Cornum health facility (P=0.25) and Rwampara (P=0.71) (Table 3).

Variable

Median

Pre-Intervention

Median

Post-Intervention

p-value

Positive

Ranks Sum

Negative

Ranks Sum

Adherence

Score (overall)

192

83.7

(73.3-85.2)

82.9

(71.1-83.2)

0.25

3402

2246

Adherence score (Cornum)

102

83.9

(73.2-84.2)

82.9

(70.4-83.2)

0.25

1218

722

Adherence

Score (Rwampara)

83.4

(82.14-83.24)

82.8

(80.33-83.24)

0.71

520

415

Table 3. Adherence to clinical guidelines.

Factors associated with maternal outcomes

There was a statistically significant association between adherence level and maternal complications (P<0.0001), Blood loss and maternal complications (P<0.0001), prolonged labor and maternal complications (P<0.00195) and causes of PPH with maternal complications (P< 0.0001) (Table 4). Conversely, there was no association between age category (P=0.19), place of residence (P=0.51), Health center (P=0.16), parity (P=0.53), concurrent illnesses (P=1.0) and maternal complications (Table 4).

Variables Modalities

Complications

n (%)

No complications

n (%)

P-value (test)

Adherence level

Did not adhere

Adhered

9 (64.3%)

5 (35.7%)

6 (1.6%)

364 (98.4%)

<0.0001* (F)

Age group

10-19 years

20-29 years

30-39 years

40-49 years

1 (7.1%)

8 (57.1%)

4 (28.6%)

1 (7.1%)

35 (9.5%)

249 (67.3%)

83 (22.4%)

3 (0.8%)

0.19 (F)

Residence

Urban

Peri-urban

10 (71.4%)

4 (28.6%)

292 (78.9%)

78 (21.1%)

0.51 (F)

Health center

Cornum

Rwampara

10 (71.4%)

4 (28.6%)

194 (52.4%)

176 (47.6%)

0.16 (F)

Insurance

No insurance

Had insurance

1 (7.1%)

13 (92.6%)

9 (2.4%)

361 (97.6%)

0.31 (F)

Blood loss

500- 1000 ml

>1000 ml

5 (35.7%)

9 (64.3%)

368 (99.5%)

2 (0.5%)

<0.0001* (F)

Parity

Primiparity

Multiparity

Grande multiparity

5 (35.7%)

8 (57.1%)

1 (7.1%)

144 (38.9%)

215 (58.1%)

11 (3.0%)

0.53 (F)

Prolonged labor

Yes

11 (78.6%)

3 (21.4%)

365 (98.6%)

5 (1.4%)

0.00195* (F)

Concurrent illnesses

None

Preeclampsia

14 (100%)

0 (0%)

369 (99.7%)

1 (0.3%)

1.0 (F)

Causes of PPH

Perineal tear

Cervical tear

Uterine atony

Retained placenta

Perineal tear and retained placenta

2 (14.3%)

8 (57.1%)

2 (14.3%)

0 (0%)

355 (95.9%)

3 (0.8%)

1 (0.3%)

9 (2.4%)

2 (0.5%)

<0.0001* (F)

*=significant test, C=chi-square test; F= Fisher’s exact test

Table 4. Factors associated with maternal outcomes.

Logistic regression analysis on adherence to clinical guidelines and maternal outcomes

We conducted a multivariate logistic regression analysis to examine the association between clinical factors and maternal outcomes. Variables in bivariate analysis with a p-value <0.100 (Age group, Residence, Health Center, Insurance, Parity, Prolonged labor, Blood loss, Cuncurrent illness and Cause) were used in multivariate analysis. Multivariate regression analysis was done using the “enter” method. Adjusted Odds ratio, (AOR) Confidence Intervals, and p-values were reported. The variables found to have a statistically significant relation to maternal outcomes are, “Prolonged labor”, “Blood loss,” and “Causes of PPH”. Adherence to guidelines reduced the odds of maternal complications by more than 99% (AOR = 0.0061, 95% CI: 0.001- 0.0264) (Table 5).

Logistic regression	Coefficient	Standard Error	AOR	CI at 95%	P-value
Adherence/maternal outcome	-6.80	0.005	0.0061	0.001- 0.0264	<0.0001*

Age/maternal outcome	0.08	1.77	1.13	0.05 – 24.31	0.94
Residence/maternal outcome	-0.50	0.73	0.42	0.01 – 13.00	0.62
HC/maternal outcome	-0.85	0.40	0.24	0.01 – 6.21	0.39
Insurance/ maternal outcome	-0.17	1.82	0.61	0.002 – 205.14	0.87

Parity/maternal outcome	-0.83	0.44	0.35	0.03 – 4.10	0.41
Prolonged labor/maternal outcome	3.85	254.35	187.25	13.07 – 2683.14	<0.0001*
Blood loss/ maternal outcome	-5.15	0.00	0.0004	0.000 – 0.008	<0.0001*
Concurrent illnesses/ maternal outcome	1
Causes of PPH/maternal outcome	-3.32	0.017	0.013	0.000 – 0.168	0.001*
Constant	0.74	8722	942.30	0.00 – 7.14e+10	0.46
*=significant test; AOR=Adjusted odd ratio; CI= AOR confidence interval at 95%

Table 5. Logistic regression of independent variables and maternal outcomes.

DISCUSSION

This present study aimed to investigate the effect of a mentorship program on healthcare providers’ adherence to PPH clinical guidelines and the maternal outcomes of women who developed PPH Nyarugenge district.

With regards to socio-demographic characteristics, the results showed an increase in the 30-39 and 20-29 age groups of healthcare providers and a decrease in the older and youngest age groups suggesting that younger healthcare providers in Rwanda might be more receptive to joining midwifery and maternal departments (Table 1). Similar studies in Sub-Saharan Africa, have shown that younger health care providers are more likely to adopt new clinical guidelines after training and mentorship programs [21]. The increase in urban healthcare providers post-mentorship might be due to better access to resources, continuous professional development, and support systems. In Rwanda, urban areas often have better healthcare infrastructure, which can facilitate better adherence to guidelines. Studies in similar settings have highlighted that urban health care providers are more likely to benefit from mentorship programs [22]. Access to health insurance can provide additional resources for training and support, but the minimal change in insurance status suggests that the mentorship program itself was the primary driver of improved adherence.

With regards to clinical characteristics, there was a slight decrease in primiparity and grand multiparity cases, with an increase in multiparity cases (Table 2). This suggests that the mentorship program might have improved the management and identification of multiparity cases, leading to better adherence to guidelines for this group. Studies in Rwanda and similar settings have shown that multiparity is often associated with higher risk of complications, and better management of these cases post-mentorship aligns with improved adherence to guidelines [23].

The increase in the identification of perineal tears and the decrease in cervical tears, retained placenta, and combined cases suggests improved diagnostic accuracy post-mentorship (Table 2). Accurate diagnosis and management of PPH causes, especially perineal tears, are critical. Improved diagnostic accuracy post-mentorship is consistent with findings from other mentorship programs in the region [23]. Similarly, there was a slight decrease in cases with estimated blood loss >1000 ml and an increase in 500-1000 ml cases suggesting an improved early intervention and management of blood loss (Table 2). Early intervention to manage blood loss is crucial, and the improvement seen here is consistent with other studies showing that mentorship programs enhance the ability of healthcare providers to manage PPH effectively [24].

Results also showed that all cases of concurrent illness (preeclampsia) were resolved post-mentorship, indicating better management and preventive measures (Table 2). Effective management of preeclampsia post-mentorship is significant, as similar studies have shown that training and mentorship programs are essential in improving the management of concurrent illnesses [25]. The complete elimination of prolonged labour cases post-mentorship indicates better intrapartum care, aligning with studies highlighting the importance of mentorship in improving

labor management [26].

Additionally, there was a slight increase in referrals to a higher level post-mentorship which could indicate better identification of cases requiring advanced care. Slightly increased referrals to higher-level care indicate better identification and management of complicated cases, which is a positive outcome seen in other similar settings [27].

With regards to healthcare providers’ adherence to clinical guidelines, the overall adherence scores showed a slight decrease post-intervention, with the median dropping from 83.7 to 82.9 (Table 3). Our threshold level for adherence was 80%, as an adherence score of 80% or more is required for optimal therapeutic efficacy [19]. The Hypothesis was that mentorship improves healthcare providers’ adherence to PPH clinical guidelines. The p-value of 0.25 indicates that this change is not statistically significant (Table 3).

These findings suggest that mentorship alone may not be the sole determinant of adherence to clinical guidelines, and other factors might play a role in influencing healthcare providers’ adherence behaviours. Contrary to our finding, a study conducted in Rwanda on a mentorship program aiming to bridge the gap in nurses’ knowledge and skills done in 21 health centres showed the program significantly improved clinical practice and quality of care delivered at rural HCs in Rwanda [20].

The lack of statistical significance in this study might be due to the short duration of the mentorship program or other contextual factors. Studies have reported varying impacts on adherence scores post-intervention, often depending on the specific clinical guidelines and the training's focus areas [25]. The slight decrease in scores in this study contrasts with some reports of increases, suggesting a need to review the mentorship program's content and delivery.

Our analysis also considered other key factors contributing to these results, such as the impact of Covid-19, as during the pandemic period, pregnancies increased, leading to increased deliveries [21]. Furthermore, other programs aimed at enhancing healthcare providers' skills could impede the

effectiveness of the current mentorship approach and adherence to established guidelines.

Another possible reason could be the fact that the documentation routine did not change after the mentorship program implementation. The lack of specific patient files for documentation may have limited the ability to observe a difference in adherence before and after the mentorship program. Without comprehensive and standardized documentation, it becomes challenging to accurately assess the level of adherence and track improvements over time. The reliance on only partographs, specific forms for monitoring labour progress, may not capture the full scope of adherence to PPH guidelines. In the context of postpartum haemorrhage (PPH) clinical guidelines, proper documentation is essential for assessing adherence to recommended protocols and ensuring optimal therapeutic efficacy [22].

The positive ranks sum is higher than the negative ranks sum, suggesting that more individuals improved their scores than those who did not (Table 3). The higher positive ranks sum in this study indicates that while the overall median adherence scores did not significantly improve, a notable number of individuals did show improvement. This is consistent with findings that mentorship programs can have differential impacts across different individuals and settings [23].

With regards to the factors associated with maternal outcomes, results showed a strong relationship between adherence to clinical guidelines and maternal outcomes. The odds of not having complications for women treated by healthcare providers who did not adhere to clinical guidelines were significantly lower than those managed by providers who adhered to guidelines (Table 5). Adherence to guidelines is associated with a higher likelihood of experiencing good maternal outcomes (Table 5). The results resonate with a post-hoc analysis study done in India on adherence to evidence-based practices during childbirth to prevent childbirth-related mortality and morbidity, where they found that adherence to WHO Safe Childbirth Checklist (SCC) during delivery was significantly associated with reduced odds of childbirth-related mortality and morbidity, and

neonatal mortality [26].

The negative coefficient and very low AOR indicated a strong negative association between adherence to clinical guidelines and poor maternal outcomes (Table 5). The significant p-value (P<0.0001) confirms this relationship, suggesting that better adherence to clinical guidelines significantly improves maternal outcomes.(Table 5). Mugisha and others also found that adherence to clinical guidelines significantly reduced maternal mortality and morbidity, highlighting the importance of training and mentorship programs in ensuring guideline adherence [23]. Both studies underscore the critical role of adherence to clinical guidelines in improving maternal health outcomes, affirming the effectiveness of mentorship programs in reinforcing these practices.

Prolonged labor shows a strong positive association with poor maternal outcomes, with a very high AOR and a significant p-value (P<0.0001) and this indicates that prolonged labor significantly increases the risk of adverse maternal outcomes (Table 5). Numerous studies, including studies in sub-Saharan Africa have shown that prolonged labour is a major risk factor for adverse maternal outcomes, emphasizing the need for timely and effective interventions [28].The significant impact of prolonged labour across studies highlights the necessity for interventions targeting labour management within mentorship programs to improve maternal health

Severe blood loss is strongly negatively associated with maternal outcomes, with an extremely low AOR and a significant p-value (P<0.0001 and this indicated that increased blood loss significantly worsens maternal outcomes (Table 5). Blood loss greater than 1000 ml was significantly associated with higher complications, indicating the critical importance of managing blood loss during postpartum.The findings align with global research, including studies which demonstrate that severe blood loss (>1000 ml) is a critical risk factor for adverse maternal outcomes, stressing the importance of effective management of hemorrhage during the postpartum period [27].

Similar studies also found that managing blood loss effectively is crucial for improving maternal outcomes, reaffirming the importance of early detection and intervention [8].

Different causes of PPH are strongly negatively associated with maternal outcomes, with a very low

AOR and a significant p-value (P<0.001), indicating that proper identification and management of PPH causes significantly improve maternal outcomes (Table 5). Ssimilar studies also highlighted the importance of identifying and managing the specific causes of PPH to improve outcomes. The agreement across studies highlights the necessity for targeted training on PPH management within mentorship programs [26].

The results showed that most women had no complications (96.4%) (Table 4). This suggests that the healthcare providers and the healthcare system effectively managed PPH and ensured positive maternal outcomes for most cases. In cases where patients had complications, a more considerable proportion (64.3%) had poor adherence to guidelines, providing compelling evidence of the association between adherence to clinical guidelines and complications as the outcome (Table 4). The results align with a cross-sectional study conducted in South Australia, highlighted a correlation between lower adherence scores, significant avoidable complications, and adverse outcomes [23].

A study examining the trend of surgical site infections in paediatric patients with complicated appendicitis found that using clinical practice guidelines was associated with lower morbidity rates after appendectomy [24]. Another study compared the safety, efficacy, and cost-effectiveness of evidence-based clinical guidelines in treating acute low back pain in primary care and usual care, searching for evidence showing whether following guidelines results in better outcomes. It found that in the short term, evidence-based care shows only slight improvement compared to usual good care. However, evidence-based guidelines demonstrate substantial and meaningful advancements over an extended period, leading to fewer patients needing ongoing treatment and experiencing persistent pain [25]. Adhering to guidelines is vital in providing appropriate evidence-based care, improving outcomes, and reducing complications. Age showed a very weak and non-significant relationship with maternal outcomes (P= 0.94) (Table 5). This suggests that age, in isolation, may not be a strong predictor of maternal outcomes, emphasizing the need to focus on other clinical and demographic factors.

Residence had a non-significant relationship with maternal outcomes (P=0.62 (Table 5). Rutayisire and others found mixed results, with some peri-urban areas showing worse outcomes due to limited access to healthcare services, but overall residence was not a significant predictor.Both studies indicate that while location may influence access to care, it is not a standalone predictor of maternal outcomes when other variables are considered [29].

The health center variable also showed a non-significant relationship with maternal outcomes (P=0.39)(Table 5). The AOR and confidence interval suggest a potential trend, but the results are not statistically significant (Table 5). This study's findings align with the idea that adequate training and mentorship can standardize care quality across different health centers, reducing outcome disparities

Insurance status shows no significant impact on maternal outcomes (P=0.87) (Table 5). A similar study reported non-significant associations between insurance status and maternal outcomes, suggesting that other factors such as quality of care and adherence to guidelines are more critical. Both studies highlight that while insurance improves access to healthcare, it does not directly translate to better maternal outcomes without high-quality clinical care [20].

Similarly, parity had a non-significant relationship with maternal outcomes (P=0.41) indicating that the number of previous births is less critical than the quality of care provided (Table 5). Similar studies have shown the same trend suggesting that parity may not be a primary concern in improving maternal outcomes compared to other clinical factors.

The logistic regression analysis highlights the significant impact of adherence to clinical guidelines, prolonged labor, blood loss, and causes of PPH on maternal outcomes. These findings underscore the critical importance of adhering to clinical guidelines, effectively managing prolonged labor and blood loss, and accurately diagnosing and treating the causes of PPH to improve maternal health.

CONCLUSION

The study results showed that though the clinical mentorship program had no significant effect in improving adherence levels to clinical guidelines for PPH, the high adherences rates observed among healthcare providers in this study contributed to positive maternal outcomes and to a reduction in the incidence of morbidity. Results suggest that mentorship programs and consistent on-job support may support maintenance of adherence behaviours among healthcare providers. However, mentorship alone may not be the sole determinant of adherence. Efforts to promote adherence should be emphasized to enhance delivery of evidence-based and standardized care for managing PPH.

Study Strengths

One advantage of this study is that it allowed us to make a temporal comparison of changes in adherence to clinical guidelines and maternal outcomes in the same facilities over time, pre- and post-mentorship. Additionally, the women in the sample were managed by the same healthcare providers before and after mentorship, with no staff turnover, reducing the effect of confounders. Moreover, using a quasi-experimental design helped us evaluate the mentorship program’s implementation in a real-world setting, reflecting the practical challenges and constraints of the actual implementation, thereby enhancing the external validity and relevance of the findings. Another advantage is that we reached the number of PPH cases needed for the sample size at the time of the study. Information was obtained from standardized medical records rather than relying on maternal or healthcare providers’ recall, thus minimizing recall bias. Another strength of the study is its long duration (4 years), which enables the implementation of changes in clinical practice and routines to be observed and analyzed. While our study cannot provide the same level of causal inference as experimental designs, we used various strategies to strengthen the causal inferences. These include careful selection and matching of comparison groups. We ensured that the medical records of women who had PPH were from the same health centers and treated by the same healthcare providers before and after the mentorship. Statistical adjustments for potential confounding variables and rigorous data analysis were also applied.

Study Limitations

It is essential to acknowledge the limitations of this study. We observed limitations in recording among the two health centers included in our study due to a lack of patient files. The only records are from the patient partographs, which are not as detailed as typical patient files; hence, this could partially explain the lack of association between mentorship and adherence. The assessment of adherence to clinical guidelines also relied on documentation in medical records, which could introduce reporting bias. Additionally, the study was conducted in a distinct setting (Muhima DH catchment area), which may limit the generalizability of the results to other healthcare contexts.

Ethics considerations.

Ethics issues have been completely observed by authors.

Funding

We want to acknowledge the University of Global Health Equity of providing technical and financial support for the successful completion of this study.

Conflict of Interest

The authors declare that there is no conflict of interest.

Acknowledgements

We want to thank JHPIEGO Rwanda for the support in the success of the research as preceptors.

We also extent our gratitude to the University of Global Health Equity for all the support.

Authors’ Contributions

Benjamin David Habikigeni: Development of the original manuscript

Arlette Bizimana: Development of the original manuscript

Maxwell Mhlanga: Review of manuscript, editing and discussion

Tsion Yohannes: Review of manuscript, editing and references

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An assessment of factors associated with full vaccination coverage rate among children aged 12-23 months in Masvingo district; Zimbabwe. A cross-sectional study

Nomore Nyengerai ¹, Maxwell Mhlanga ²*

Department of Public Health, University of Zambia
Centre of Gender Equity, University of Global Health Equity, Zimbabwe

* Corresponding author: Maxwell Mhlanga., Centre of Gender Equity, University of Global Health Equity. Rwanda. E-mail: mmhlanga@ughe.org

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ABSTRACT

Introduction: Immunization is one of the most cost-effective nursing interventions aimed at reducing ill health and premature death among children. Despite tremendous efforts by governments, vaccination coverage remains low, especially in developing countries. Masvingo district is one of the districts with low vaccination coverage in the country.

Objectives: This study sought to assess immunization coverage, identify determinants of vaccination coverage and assess factors associated with low full immunization coverage in Masvingo district, Zimbabwe.

Methods: An analytical cross-sectional study design was conducted between January 2019 and February 2019. Masvingo province was purposively selected due to its low vaccination coverage (60.3%) according to the Zimbabwe Demographic and Health Survey 2015. WHO cluster sampling was used to select households. A total of 354 children and their mothers residing in Masvingo district were recruited for the study. Pre-tested interviewer-administered questionnaires were used to collect data. Bivariate analysis was employed to assess factors associated with low vaccination coverage.

Results: An estimated 89.5% of children aged 12-23 months were fully vaccinated by card or mothers’ recall. Factors significantly associated with full vaccination coverage rates (P<0.001) included birth order, distance to the nearest health facility, waiting time, place of birth, number of Antenatal care visits, possession of a vaccination card, place of residence, mother/caregiver’s highest level of education, household expenditure per month, and overall knowledge of the vaccination schedule. After controlling for all these factors, only household expenditure per month (P=0.001), having a vaccination card (P=0.047), and overall knowledge of the vaccination schedule (P=0.002) were statistically significant predictors of full vaccination coverage rates.

Conclusion: Although full vaccination coverage is improving, it is still below the Global Vaccine Action Plan target. Factors associated with low full vaccination coverage include marital age, marital status, level of education, religion, household expenditure, distance to the health center, waiting time, and Antenatal Care and Post-natal Care care utilization. There is no single factor solely responsible for low vaccination coverage; rather, it is influenced by a combination of multiple factors. Nursing interventions at community level should focus on increasing community mobilization strategies that foster saturation coverage to achieve herd immunity for all vaccine preventable child diseases.

Keywords: Vaccination coverage, utilization, children, cross-sectional study, community mobilization, vaccination hesitancy

INTRODUCTION

In 1974, the World Health Organization (WHO) launched the Expanded Programme on Immunization (EPI) and nurses have played a pivotal role in the success of this programme and in promoting universal health coverage through the primary health care approach. The aim of the EPI was to administer life-saving vaccines to all eligible children across the globe. At that time, only six diseases—pertussis, poliomyelitis, tuberculosis, tetanus, measles, and diphtheria—were targeted [1]. Vaccination is regarded as the most economical child survival intervention, improving children’s quality of life while preventing sickness, disability, and death from vaccine-preventable illnesses [1]. According to UNICEF, each dollar spent on vaccination brings about USD 44 in economic benefits through therapeutic cost savings and productive time loss [2]. Nurses are at the centre of successful child vaccination programmes through as they are the ones who implement the Expanded programme of immunisation at both health facility and community level.

According to WHO, the proportion of children vaccinated against the six vaccine-preventable diseases was around 5% initially. This figure has increased to over 80% during the past four decades [3]. This improvement follows the integration of immunization services into broader public health services by many governments. The Global Vaccine Action Plan (GVAP) was launched in 2012 by WHO and partners, with the primary goal of ensuring equitable access to vaccines, thereby preventing avoidable child illnesses, disability, and death. The coverage level set by GVAP for countries is 90% and above for DTP3 and a minimum of 80% in each district by the year 2020 [3]. WHO highlighted that only 123 countries managed to achieve this target by 2017 [1].

Despite the remarkable increase in global vaccination coverage, it still falls below the target set by GVAP [1]. Due to inequitable distribution of nursing and general health services, including immunization, many children, particularly in developing countries, remain unvaccinated. WHO and UNICEF predict that two in every 20 children are left unvaccinated, while 20% of children do not receive all required vaccine doses. In 2017 alone, around 19.9 million children did not receive all three doses of DTP3 during their first year of life. Additionally, about 33.3% of children under 5 years old die from diseases that could be prevented by vaccines [1].

The government of Zimbabwe, through the Ministry of Health and Childcare, introduced the Zimbabwe Expanded Programme on Immunization (ZEPI) in 1982 [4]. Initially, the government adopted the WHO recommendation of vaccination against only six diseases. As research continued and new vaccines were developed, the government made great strides in incorporating them into routine immunization [4]. In 1999, the Hepatitis B vaccine was introduced, followed by the Pentavalent vaccine (DTP-HB-Hib) in 2008. Haemophilus influenzae was included as part of the Pentavalent vaccine. To combat pneumonia, the Pneumococcal Conjugate Vaccine (PCV) was introduced in 2012, followed by the Rotavirus vaccine in 2014 to fight diarrheal diseases [4]. The second dose of the measles vaccine, including the rubella component, was introduced in 2015. In 2018, the government rolled out the Human Papillomavirus (HPV) vaccine nationwide for girls aged 10 to 14 years following a successful pilot project started in 2014.

In Zimbabwe, children are considered fully vaccinated if they receive the following: BCG at birth or first contact, three doses of oral polio vaccine, three doses of Pentavalent, three doses of PCV, two doses of Rotavirus vaccine, and a single dose of measles [4]. These doses should be administered during the first year of life. The Multiple Indicator Cluster Survey (MICS) of 2014 revealed that only 69.2% of children aged 12 to 23 months were fully vaccinated at the time of the survey, and 5% were unvaccinated [5]. Similarly, the Zimbabwe Demographic and Health Survey (ZDHS) of 2015 found that only 73% of children in the same age group were fully vaccinated, while 9.8% were unvaccinated [6]. Despite differences in survey methodologies, both highlighted inadequacies in meeting the GVAP targets for DTP3 (90%) and measles-rubella (95%). This leaves the country vulnerable to outbreaks of vaccine-preventable diseases. Except for BCG, the Multiple Cluster Survey of 2014, all other vaccine coverages were far below the GVAP target [6].

According to both the Multiple Indicator Cluster Survey and the Demographic Health Survey, Masvingo province had the lowest vaccination coverage in the country, with 78.1% and 60.3% respectively [6]. The 2015 Demographic Health Survey revealed that Masvingo province recorded the highest proportion (20.7%) of unvaccinated children.

In Zimbabwe, children are vaccinated through static and outreach services conducted by community nurses and primary health care nurses. According to the Ministry of Health and Childcare, all primary course vaccines should be administered during the first year of life. BCG is given at birth or the first contact, while the other three sets of vaccines are administered from 6 weeks to 14 weeks at four-week intervals. Thereafter, the measles-rubella vaccine is given at 9 months. Given the vulnerability of children under 2 years to various illnesses, polio and measles vaccines are administered at 18 months to boost their immune systems. Extra doses are typically given during campaigns.

The Global Alliance for Vaccines (Gavi) and partners initiated the EPI programme in 1974 to expand immunization services and prevent avoidable illnesses and deaths in children. From 1974 to 2014, global coverage of EPI services increased from 5% to 80% [3]. Although global coverage shows an increasing trend, it remains below the GVAP targets [1]. Consequently, many children, especially in developing countries, are either unvaccinated or partially vaccinated. WHO and UNICEF of 2018 report that two out of every 20 children are left unvaccinated, while one does not complete all recommended vaccine doses [1]. WHO estimates that approximately 19.9 million children did not receive the DTP3 vaccine, and around 33.3% of children under the age of 5 die from vaccine-preventable illnesses [1].

The government of Zimbabwe identified three diseases (pneumonia, diarrhoea, and measles) as among the top five causes of avoidable and premature death in children under 5 years. This implies that the vaccination programme is a critical child survival activity that can improve children's quality of life [7]. The government and EPI partners provide technical, financial, and coordination support to expand, improve, and intensify the EPI programme. Various initiatives have been implemented to improve immunization coverage, including health worker training, providing vehicles for EPI activities, supplying cold chain equipment, and implementing strategies like Reach Every Child (RED), My Village My Home, and Child Health Days [8]. However, despite these initiatives, vaccination coverage decreased from 90% in 2014 to 87% in 2017 [9]. Masvingo district's coverage has remained persistently low, consistent with findings from MICS of 2014 and DHS of 2015 [5-6]. Although several studies have explored factors linked to low vaccination coverage, none have been conducted specifically in Masvingo district. Given the persistent low immunization coverage in Masvingo district, determining the factors associated with this low performance is critical. The findings will inform health promotion messaging and ultimately generate demand and utilization of immunization services.

Objective: This study sought to assess immunization coverage, identify determinants of vaccination coverage and assess factors associated with low full immunization coverage in Masvingo district, Zimbabwe.

MATERIALS AND METHODS

Study setting and design

This study was carried out in Masvingo district, Zimbabwe. The district is 292 km to the south of Zimbabwe’s capital, Harare and is bordered by Gutu district on the north, Chiredzi district south, Zaka and Chivi districts on the east and west respectively. The latest data based on 2012 census projections showed that its’ population is approximately 224,209 and 7,041 are under-5-year-old children [4].

An analytical cross-sectional study was conducted between January 2019 and February 2019. Masvingo province was purposively selected because she had the lowest (60.3%) vaccination coverage according to ZDHS (2015) [6]. WHO cluster sampling was used for selecting the households.

Study population and sampling

The source population of this study were all children within 12 to 23 months age group with their parents residing in Masvingo district. The study population consisted of 354 children within this age group whose mothers/caregivers were sampled.

Case definition: A Case was any child aged 12 to 23 months residing in Masvingo district full immunised between January 2019 and February 2019 confirmed by a child health card/ mother recall.

Sample Size and Sampling Methodology

Masvingo province has the lowest (60, 3%) vaccination coverage according to ZDHS thus was purposively samples [6]. Also, the province had the highest percentage (20.7%) of unvaccinated children with 12 months to 23 months. Furthermore, the administrative data from 2005-2017 revealed that Masvingo district was one of the persistent low performers in the province.

The sample size required was determined using single proportion population formula with 5% margin of error assumption (D), 95% confidence level (), and the immunization coverage assumed between 60% in Masvingo to 87% in Matabeleland North as per ZDHS 2015. Therefore, we we hypothesized a prevalence p = 73%, so that the hypothesized prevalence is within the range [68%, 78%]. The required sample size for this study was computed as follows:

where n = minimum estimate sample size; /2 at 95% CI is 1.96; D =margin of error- 5%; hypothesized a prevalence of fully immunized coverage p = 73%. Finally, the sample size was enlarged to 354 mothers to reduce possible statistical biases due data loss.

Sampling was done in accordance to WHO’s multistage cluster sampling [9]. The district was divided into three clusters namely Masvingo South, North and central. Then, fifteen villages were selected from each cluster making a total of 45 villages from all clusters using lottery method. The total sample size was allocated proportionally to villages depending on the number of 12-23 months old children. The first child from each village was selected randomly and the rest of the children were selected from subsequent households until the sample size is fulfilled. In case of two and above eligible children in a household, the investigator will randomly select one child.

Inclusion and Exclusion Criteria

Inclusion Criteria

All mothers/caregivers aged 16 years and above.
Mothers/caregivers of children aged 12-23 months residing in Masvingo district for at least 12 months prior to data collection date.
Adults willing and able to give informed consent to take part.

Exclusion Criteria

All mothers aged 15 years and below
All mothers/ caregivers of children below the age of 12 months and those above 23 months.
Mothers/ caregivers of children residing outside Masvingo district or has been in Masvingo district for a period less than 12 months.
Mothers/caregivers who were unwilling to participate or incapacitated to give consent.

Data Collection

The survey was conducted in Masvingo district from January to February 2019. The investigator collected information on demography, vaccination status, health services utilisation and other relevant information using interviewer-administered structured questionnaires. The questionnaires were developed from review of immunisation literature, adapted from Zimbabwe Demographic Health Survey and WHO questionnaires for immunisation coverage.

The questionnaire was evaluated for test-retest reliability with 10 people randomly selected at Zaka rural health centre who were from non-participating villages. The test-retest assessments were 5 days apart. Participants were not told that they would be re-tested to minimise bias. Item completion of the questions and percentage agreement between test–retest assessments was calculated for each question and it was in the range of 90-100% for all questions. Based on these results the questionnaire was adopted for use in the study.

Face and construct validity was enhanced through subjecting the questionnaire to review by Experts public health and aligning the research instrument to the conceptual framework that informed behaviour and immunisation services uptake.

The questionnaires were pretested at Gutu Mission Hospital to check for acceptability of the data collection tool, to estimate response rate, questions that are difficult to answer and estimating the length of time to complete the questionnaire so that adjustments were made to the data collection tools. The pretested study area was not included into his study.

Dependent variable

In this study, the vaccination status of the child was the dependent variable. According to Ministry of Health and Child Care ZEPI policy, children are said to be fully vaccinated when given BCG (one dose), Polio, PCV and Pentavalent (three doses each), Rotavirus (two doses) and Measles Rubella (one dose) during the first year of life [6]. In this analysis, fully vaccination status was a dummy variable derived from summing up all the above stated vaccines as per Zimbabwe Expanded Programme on Immunisation schedule. The information on antigens given and dates of administration was extracted from children’s vaccination records or mothers’ recall if records were not available. In cases where vaccination records were absent, the caregiver was asked to report the period and number of doses for each antigen given in order to ascertain the vaccination status of the child. In a bid to minimise recall bias, recalling techniques like period of administration, route and site of administration were included in the instruments.

The vaccination dates were recorded against each antigen from the vaccination card or caregiver’s recall. Vaccination dates were checked against the recommended ZEPI schedule. In cases where the vaccination date was wrongly or not recorded, the antigens were considered as not administered. Children with 12 months to 23 months’ vaccination status were categorised as fully immunised and partially or unvaccinated. The child was considered partially/ incompletely vaccinated when one or more doses were missed. Children who did not receive any antigen were classified as unvaccinated.

Independent variables

The demographic and socio-economic characteristics of the child, mother, health systems, and utilization were the independent variables. These included the sex, age, and birth order of the child; the age, education level, occupation, and marital status of the mother; religion; distance from the health facility; travel time; health facility utilization; place of residence (rural-urban); and communication and knowledge of the immunization schedule.

Data Analysis

In this analysis, SPSS version 20 and STATA 15 were used for capturing, cleaning and tabularisation of all the data collected using questionnaires. The descriptive data was presented in tables as figures as frequencies and percentages. The chi-square test or Fisher’s exact test were performed to evaluate significant differences in proportions or percentages between the two groups. Fisher’s exact test was used where the chi-square test was not appropriate.

Univariate analysis was employed to describe distribution of children’s full vaccination status by characteristics of child, mother and health system and utilisation. Predictors for the vaccinations of the children were assessed by dichotomizing outcome variable (child vaccination status) into fully vaccinated and not fully vaccinated. Predictor variables having a p-value < 0.05 were taken into a multivariable logistic regression analysis to see associations between dependent and independent variables. All independent variables identified to significantly associate with the vaccination statuses of the children at bivariate analysis (p-value < 0.05) were taken into a multivariable analysis. We used the “ENTER” approach for multi-variable regression analysis to assess the association between children’s full vaccination status and factors associated with their vaccination status. Finally, all p-values were always two-sided and all tests with p-value (P) < 0.05 were considered significant.

Ethical Considerations

The investigators obtained ethical approval from the Ethics Committee of the University of Lusaka and the Medical Research Council of Zimbabwe approval number MRCZA/2099, approved on 11 January 2019.

The permission to collect data was sought from Masvingo Provincial Medical Director and Masvingo District Medical Officer respectively.

A written consent was obtained from all participants prior to each interview session.

All the participants were assured that they can withdraw from the process whenever they wanted with no disadvantage to their care.

Privacy and confidentiality were maintained throughout the study process. Measures to ensure confidentiality where clients were told that no information shall be shared to other people and privacy were carried out.

RESULTS

Full vaccination coverage rate in Masvingo district

A total of 354 caregivers and their children participated in this study. The full vaccination rate among children aged 12 to 23 months in Masvingo District was found to be 89.3% (316). The full vaccination coverage rate by vaccination card was 88.1% (312) (Table 1).

Variable (n=354)

Full immunisation status

No vs Yes

p-value (test)

No (%)

Yes (%)

Possession of a vaccination card

Yes- card not seen

Yes- card seen

10 (26.3)

7 (18.4)

21 (55.3)

4 (1.3)

5 (1.6)

307 (97.2)

<0.001* (F)

Ever had a vaccination card

Yes

26 (68.4)

12 (31.6)

316 (100.0)

0 (0.0)

<0.001* (F)

*=significant test, F= Fisher’s exact test

Table 1. Presumed factors associated with vaccination coverage rates

Out of 37 caregivers whose children missed one or more vaccines, the majority 15 (28%) cited

religious reasons, long walking distance to the vaccination site 11 (20%), and unavailability of the vaccine 10 (19%) as the major causes of missing the vaccines.

Fear of side effects and inconvenience of vaccination time contributed 11 and 7 percent respectively. Other reasons cited were mobility to neighboring countries in search of greener pastures (15%).

Summary of reasons for missing any vaccines are presented graphical on figure—below.

Figure 1. Reasons for missing any vaccine among 12-23 months age group in Masvingo district

Socio-demographic characteristics of the study participants

Of the 354 children aged 12 to 23 months included in the study, 152 (42.9%) were males and 202 (57.1%) were females. The mean age was 16.6 months (SD = 0.17). Most (66.9%) of the children were of the 1st-2nd birth order, 27.2% (96) were of the 3rd-4th birth order, and 5.9% (21) were of the 5th birth order or higher. The majority, 73.4%, lived in rural areas, while 26.6% resided in urban areas.

The majority of children, both fully immunized and not, were in the 16–20-month age group. Among those not fully immunized, 55.2% were males. About 84% of the children not fully immunized lived in rural areas and were mainly of the 3rd-4th birth order.

The majority of caregivers in both groups were aged 18-24 years and were married: 92.1% in the

not fully immunized group and 94.0% in the fully immunized group. There was a statistically significant association between caregivers' highest level of education and the child's immunization status (p<0.001). Most caregivers in both groups were not employed outside the home.

Regarding household expenditure, the majority of those with not fully immunized children spent

less than 50 USD per month (84.2%), whereas the majority of those with fully immunized children spent 50-500 USD per month. Most children not fully immunized (78.9%) belonged to apostolic religious groups, while the majority of fully immunized children (88.6%) were non-apostolic. There was a statistically significant association between immunization status and religion (P<0.001). Additionally, the majority of caregivers with not fully immunized children were non-professional health workers, compared to 56.6% of caregivers with fully immunized children who were professionals.

Tables 2 and Table 3 below present the socio-demographic characteristics of the study participants by immunization status.

Variable (n=354)

Full immunisation status

No vs Yes

p-value (test)

Yes

Child’s age group in months

12 - 15

16 - 20

21 – 23

14 (36.8)

15 (39.5)

9 (23.7)

129 (40.8)

146 (46.2)

41 (12.9)

0.20 (C)

Sex

Male

Female

21(55.2)

17 (44.8)

131(41.5)

185 (58.5)

0.10 (C)

Residence

Rural

Urban

32 (84.2)

6 (15.8)

228 (72.2)

88 (27.8)

0.11 (C)

Child’s birth order

1st-2^nd

3rd-4^th

5th and above

13 (34.2)

19 (50.0)

6 (15.8)

224 (70.9)

77 (24.4)

15 (4.7)

<0.001* (C)

Maternal/caregiver age group in years

Less than 18

18 – 24

25 – 40

40+

2 (5.3)

21 (55.2)

14 (36.8)

1 (2.6)

8 (2.5)

179 (56.6)

124 (39.2)

5 (1.6)

0.79 (F)

Marital status

Married

Never married

35 (92.1)

3 (7.9)

297 (94.0)

19 (6.0)

0.65 (F)

Mothers’ Highest level of education

Primary

Secondary

Tertiary

22 (57.9)

16 (42.1)

0 (0.0)

47 (14.9)

238 (75.3)

31(9.8)

<0.001* (F)

*=significant test; C=chi-square test; F= Fisher’s exact test

Table 2. Socio-demographic characteristics of participants by immunisation status.

Variable (n=354)

Full immunisation status

No vs Yes

p-value (test)

Yes

Work outside home

Yes

1 (2.6)

37 (97.4)

53 (16.8)

261(82.6)

0.021* (C)

Household expenditure in USD

Less than $50

$50-500

Above $500

32 (84.2)

6 (15.8)

0 (0.0)

65 (20.6)

243 (76.9)

8 (2.5)

<0.0001* (F)

Religion

Apostolic

Non-Apostolic

30 (78.9)

8 (2.1)

36 (11.4)

280 (88.6)

<0.0001* (C)

Occupation

Professional

Non-professional

1 (14.3)

6 (85.7)

30 (56.6)

23 (43.3)

0.049* (F)

*=significant test; C=chi-square test; F= Fisher’s exact test

Table 3. Socio-demographic characteristics of participants by immunisation status

Health services accessibility and utilization

Regarding the distance from the health facility, a greater proportion (55.3%) of children who were

not fully immunized lived more than 10 km from the nearest facility, whereas the majority (58.2%) of those fully immunized lived within 5 km of the nearest clinic. The association between distance from the health facility and immunization status was very significant (P<0.001). The majority of caregivers in both groups perceived that the waiting time at the health facility was too long, and there was a significant association between immunization status and perceived waiting time at the health facility (P<0.001). All children who were fully immunized had caregivers who had attended ANC, and the association between ANC attendance and immunization status was very significant (P<0.001). Mothers who had attended more than four ANC visits were least likely to have their children not fully immunized (P<0.001). The majority (98.1%) of caregivers whose children were fully immunized had delivered at a health institution, and the association between place of birth and immunization status was very significant (P<0.001). Women who had four PNC visits and had a discussion with nurses about vaccination were more likely to have their children vaccinated (P<0.001), (Table 4).

Variable (n=354)

Full immunisation status

No vs Yes

p-value (test)

Yes

Distance from health facility

Less than 5km

5- 10km

Above 10km

7 (18.4)

10 (26.3)

21 (55.3)

184 (58.2)

105 (33.2)

27 (8.5)

<0.001* (C)

Waiting time at facility

Too long

Reasonable

20 (52.6)

18 (47.4)

296 (93.7)

20 (6.3)

<0.001*(C)

ANC attendance

Yes

31(81.6)

7 (18.4)

316 (100.0)

0 (0.0)

<0.001* (F)

Number of ANC visits

No visit

1-3 visits

4+ visits

7 (18.4)

24 (63.2)

7 (18.4)

0 (0.0)

86 (27.2)

230 (72.8)

<0.001*(F)

Place of birth

Health institution

Non-Health institution

25 (65.8)

13 (34.2)

310 (98.1)

6 (1.9)

<0.001*(F)

Number of PNC visits attended

None

Less than 4

4 visits

7 (18.4)

26 (68.4)

5 (13.2)

0 (0.0)

51 (16.1)

265 (83.9)

<0.001*(F)

Discussion with nurse about vaccination

Yes

22 (57.9)

16 (42.1)

305 (96.5)

11(3.5)

<0.001*(C)

*=significant test; C=chi-square test; F= Fisher’s exact test

Table 4. Summary of health services access and utilisation

Information, communication and knowledge

In relation to information and communication, results showed a statistical significant association between source of health information and immunisation status (P<0.001). The most frequent sources of information mentioned were health workers (79.9%), community leaders (92.9%), radios (42.1%) and Village Health Workers (30.8%). The results of the study revealed that the television and the newspapers were the least frequently used sources of information with 16.4% and 4% respectively. Regarding mothers’/ caregivers’ knowledge of schedule for immunization, the majority, 318 (89.8%) gave the correct timelines for all antigens while 36 (10.2%) had limited or no knowledge. Most of the respondents were well versed with vaccination schedule for BCG (95.4%) and Measles (94.4%). Despite these high knowledge levels, 14 (4%) indicated that they know nothing about the immunization schedule. Children born to mothers with partial knowledge on the vaccination schedule (71.1%) were less likely to be fully immunised whereas those born to fully knowledgeable mothers were more likely to be fully vaccinated (P<0.001) (Table 5).

Variable (n=354)

Full immunisation status

No vs Yes

p-value (test)

Yes

Knowledge of vaccination schedule

OPV

No dose

1-2 doses

3 doses

10 (26.3)

7 (18.4)

21 (55.3)

4 (1.3)

5 (1.6)

307 (97.2)

<0.001 (F)

PENTAVALENT

No dose

1-2 doses

3 doses

10 (26.3)

8 (2.1)

20 (52.6)

4 (1.3)

5 (1.6)

307 (97.2)

<0.001* (F)

PCV

No dose

1-2 doses

3 doses

10 (26.3)

11 (28.9)

17 (44.7)

4 (1.3)

5 (1.6)

307 (97.2)

<0.001*(F)

MEASLES

No dose

2 doses

10 (26.3)

28 (73.7)

7 (2.2)

310 (97.8)

<0.001* (C)

Overall Knowledge level

Partial knowledge

Full knowledge

27 (71.1)

11 (28.9)

9 (2.8)

307 (97.2)

<0.001* (C)

*=significant test; C=chi-square test; F= Fisher’s exact test

Table 5. Knowledge of vaccination schedule

Predictors of full vaccination coverage rate in Masvingo district

The study did a multivariate binary regression analysis to determine the predictors of full vaccination coverage rate in Masvingo district. All factors that had a statistical significant association with immunisation status were controlled for and these included birth order, mothers’ level of education, spouse’s level of education, work outside home, household expenditure per month, religion, having a vaccination card, distance to the clinic, time to reach health facility, waiting time at outreach and overall knowledge level on immunisation schedule. Only household expenditure per month (AOR=18.77, 95% CI = 3.13-11.21), having a vaccination card (AOR=11.78, 95% CI = 1.03-13.41) and overall knowledge on vaccination schedule (AOR=10.01,

95% CI = 2.32-43.25) were statistically significant predictors of full vaccination coverage rates

(Table 6).

Immunisation status and:	Coefficient	Adjusted Odds ratio (AOR)	AOR CI at 95%	p-value
Birth order	1.15	2.14	0.58 – 7.84	0.25
Mother’s level of education	-0.05	0.96	0.17 – 5.33	0.96
Spouse’s level of education	1.08	2.64	0.46 – 15.30	0.28
Work outside home	1.92	11.91	0.95 – 14.90	0.051
HH expenditure per month	3.21	18.77	3.13 – 11.21	0.001*
Religion	1.66	4.92	0.75 – 32.47	0.098
Having a vaccination card	1.99	11.78	1.03 – 13.41	0.047*
Distance to the clinic	-0.71	0.09	0.01 – 68.56	0.48
Time to reach clinic	0.82	16.06	0.02 – 12.56	0.41
Waiting time at outreach	0.86	2.46	0.32 – 19.04	0.39
Overall knowledge on vaccination	3.09	10.01	2.32 – 43.25	0.002*
* =significant test

Table 6. Predictors of full vaccination coverage rate in Masvingo district.

DISCUSSION

Full vaccination coverage rates

Based on the results of this study, full vaccination coverage by both card and mother’s recall was found to be 89.5%. This coverage is much higher compared to the provincial coverage of 78.1% [5], 65.4% [7], 60.3% [6], and 85% [10]. The finding was also higher than the 64% rate that had been reported in the previous 2011 ZDHS report [11]. These variances may be attributed to different methods used, areas covered, data quality issues, and denominator differences. Children with vaccination cards were more likely to be fully vaccinated (P<0.001).

In line with Meleko’s finding in 2015, this study established that more children (82.6%) with vaccination records/cards were fully vaccinated compared to those without [12]. Similar studies conducted in Ghana, Bangladesh, and India after the peak of the COVID-19 pandemic reported full vaccination coverage rates for children 12-23 months that ranged from 67% to 88% [13-15]. This suggests that vaccination cards, which contain vital information such as milestones and vaccination schedules, act as reminders to parents. Low vaccination among those without cards may be attributed to mothers’/caregivers’ recall bias. Similar to previous studies [7, 12], this study revealed variations in antigens given at the same period, such as OPV 3 and DTP 3. These variations suggest missed opportunities due to stock-outs, poor screening, and data quality issues. Policymakers should ensure and monitor that vaccination cards are distributed freely, reaching even the remotest mother-child pairs to promote high full vaccination coverage rates in Masvingo.

Socio-Demographic Characteristics of the Study Participants

This study assessed the association of full vaccination with the index child's sex, age, birth order, and place of residence. No evidence suggested that the child's sex influenced vaccination status, consistent with findings from ZDHS of 2015, Mukungwa in 2015, and studies in Ethiopia and Indonesia [6-7]. However, birth order was a significant predictor; higher birth orders were associated with lower vaccination rates, as seen in previous studies. This trend may reflect decreased enthusiasm and increased resource competition with higher birth orders.

Place of residence also showed a significant association with full vaccination. Contrary to Mukungwa’s findings, this study found that children in rural areas were more likely to be fully vaccinated than those in urban areas (OR=0.48, 95% CI = 0.01-0.93). This may be due to the increased number of urban poor who cannot afford health services.

Factors significantly associated with full vaccination status included maternal age, marital status, mother's education, spouse's education, household expenditure, and religion. Marital status was a key determinant, with married mothers more likely to fully vaccinate their children (OR=1.33, 95% CI = 1.12-5.56), possibly due to additional resources and support from spouses. Similar studies in low to medium income countries showed the same trends even after the Covid-19 pandemic [13-15].

Education level also positively influenced vaccination rates. Educated mothers are more likely to seek health services, though other factors still play a role. Fathers' education similarly impacted vaccination status, likely due to their ability to make informed health decisions. This aligns with findings by Meleko and others, which reported that children of literate fathers were 2.42 times more likely to be fully vaccinated [12].

Employment type significantly affected vaccination rates. Children of non-professional workers were less likely to be fully vaccinated compared to those of professional health workers. Monthly household expenditure also correlated with vaccination status; children in households spending less than $50 per month were less likely to be fully vaccinated. This underscores the need for community health insurance models to enhance equity in health service access.

Economic status, measured by household expenditure, was another predictor of full vaccination. Wealthier families exhibited better health-seeking behaviors, despite free vaccination services in Zimbabwe, suggesting that indirect costs like transportation influence vaccination decisions.

Religious affiliation also impacted vaccination coverage. The study found that 54.5% of children from apostolic sect families were partially or unvaccinated, compared to 97% from other Christian denominations. Despite efforts to raise health awareness among apostolic sect members, some still prefer faith healing over modern medical interventions, confirming Mukungwa's findings [12].

Health Service Accessibility and Utilization

Distance to the nearest health facility, waiting time, place of delivery, antenatal care (ANC) and postnatal care (PNC) clinic services utilization, and having a vaccination card were found to influence the likelihood of full vaccination. Children born to mothers who walk more than 10 km to a health facility are 13 times less likely to be fully vaccinated than those who walk less than 10 km (OR=13.22, 95% CI = 5.77-17.01). This finding aligns with studies by UNICEF, Mukungwa, and Legesse and Dechasa, which identified long walking distances as a barrier to immunization [7, 16-17].

Contrary to Ayano (2015), this study found no significant association between travel time and full vaccination status [18]. However, mothers who deemed waiting times reasonable were 13 times more likely to fully immunize their children (OR=13.32). This result highlights the importance of reducing wait times, particularly during busy seasons.

Antenatal care utilization strongly correlates with full vaccination status. Mothers who attended at least four ANC visits were more likely to fully vaccinate their children, consistent with studies by Mukungwa, Sunguti et al., and Herliana and Douiri [7,12,19]. The World Health Organization recommends at least four ANC visits, during which mothers receive education on child care and immunization. This study found that 97% of women who attended four or more ANC visits fully vaccinated their children, compared to 73.7% who attended fewer visits.

Place of delivery also significantly influenced full vaccination status. Mothers who gave birth at health facilities were 27 times more likely to vaccinate their children (OR=26.67; 95% CI: 16.74-36.55). This finding aligns with previous studies and highlights the importance of health facility deliveries, where vaccination is initiated before discharge and mothers receive guidance on future vaccinations.

Postnatal care follow-up visits were another strong predictor of full vaccination. This study revealed that 98% of mothers who attended the recommended four PNC visits fully vaccinated their children, compared to 60.7% among those who attended fewer visits. PNC clinics provide opportunities for health professionals to administer due and overdue vaccines and discuss child health issues.

Discussions about vaccination with health professionals during pregnancy significantly influenced full vaccination status. Children of mothers who had such discussions were more likely to be fully vaccinated, consistent with findings by from similar studies [13-15,17]. These discussions positively impact mothers' health-seeking behaviors, leading to increased demand and utilization of

immunization services and higher full vaccination coverage for children aged 12-23 months.

Communication, Information, and Knowledge

Though there was a significant association between the source of information and full vaccination,

the majority (79.9%) of mothers and caregivers received information about immunization from health workers and community leaders. This is likely due to the fact that most (73.4%) study participants were from rural areas where access to electronic and print media was limited. The study revealed a significant association between mothers' and caregivers' knowledge about the vaccination schedule and the full vaccination status of the index child. This result is consistent with previous studies which found that knowledge about vaccination was a significant determinant of the full vaccination status of index children [12,18]. It also aligns with findings by Xeuatvongsa et al., which showed that low full vaccination coverage was mainly due to limited knowledge about immunization [20].

Predictors of full immunisation coverage

After controlling for birth order, mothers’ level of education, spouse’s level of education, work outside the home, household expenditure per month, religion, having a vaccination card, distance to the clinic, time to reach the health facility, waiting time at outreach, and overall knowledge level on the immunisation schedule, only household expenditure per month (AOR=18.77, 95% CI = 3.13–11.21), having a vaccination card (AOR=11.78, 95% CI = 1.03–13.41), and overall knowledge of the vaccination schedule (AOR=10.01, 95% CI = 2.32–43.25) were statistically significant predictors of full vaccination coverage rates. These factors should be fully addressed in the community health strategy to improve full immunisation coverage rates in Masvingo district.

These results are crucial for nursing. Understanding these factors enables nurses to identify barriers

to immunization, which is essential for preventing childhood diseases. Enhanced vaccination

coverage ensures community health, reduces morbidity and mortality rates, and lowers healthcare costs by preventing outbreaks. Moreover, insights from this study can guide nurses in developing targeted interventions, educational campaigns, and policy recommendations to improve vaccination rates, ultimately leading to better health outcomes for children and the broader community. This aligns with nursing's core mission of promoting public health and disease prevention.

Limitations

In the absence of vaccination records, information about the index child’s vaccination status was obtained from the mothers’ or caregivers’ recall. Thus, the accuracy of the information relied on the mothers’ or caregivers’ ability to precisely remember the vaccination period and antigens given to the child. Additionally, the accuracy depended on the mothers’ or caregivers’ honesty. This information is subject to recall bias. This study was a cross-sectional survey and could only assess the association between various risk factors and full vaccination coverage but not causal inferences. Similarly, there are chances that the coverage rates could have changed significantly between the time the study was conducted and now since in between the Covid-19 pandemic struck and pandemics have always been associated with reduction in vaccination coverage rates.

Strength

One person collected the data for this study, eliminating the chances of inter-observer biases. Most of the mothers and caregivers had vaccination cards available, enhancing the accuracy of the data.

CONCLUSION

This study assessed factors linked to low full vaccination coverage among children aged 12-23 months in Masvingo district, finding a coverage rate of 89.5%, higher than previous estimates but still below GVAP targets for some vaccines like measles. Socio-demographic factors such as birth order, place of residence, family and maternal factors, and household expenditure significantly influenced vaccination. Accessibility to health facilities, waiting times, antenatal and postnatal care utilization, and possession of a vaccination card were also crucial. Effective outreach and integrated approaches, including educational programs and promoting maternal and child health activities, are essential to improving vaccination coverage and should be prioritized in nursing strategic planning for effective community mobilization. Health system strengthening measures should also consider strengthening the supply chain for vaccines and effective distribution strategies to improve access to vaccination services. It is crucial that community nursing interventions employ innovative approaches to ensure saturation coverage and easy accessibility of maternal and child services to address barriers to full coverage.

Funding statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors.

Conflict of interest

The authors report no conflict of interest.

Authors’ contribution

Nomore Nyengerai: Development of the original draft; Maxwell Mhlanga: Review of the manuscript, data analysis and discussion.

Acknowledgements

We would want to acknowledge Masvingo Provincial Medical Directorate for allowing us to carry out our research at their institution.

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by Izeos

Assessment of the Impact of Smart Refrigerators on the Preanalytical Phase to Enhance the Transport and Storage of Blood Samples in Primary Care

Vidal Navarro Ana ¹. Férriz Tena Náyades ¹. Carreres Giménez María Encarnación ¹. Verdu Quirant Trinidad ¹. Menchón Simón María de las Nieves ². Campello García María José ². Serrano López Juan Francisco ² and Soler Climent Esther ³*.

Primary Care. Health Department Elche General Hospital, Elche, Alicante, Spain; FISABIO, Valencia, Spain.
Clinical analysis laboratory. Health Department Elche General Hospital, Elche, Alicante, Spain; FISABIO, Valencia, Spain.
Research and Innovation Area. Health Department Elche General Hospital, Elche, Alicante, Spain; FISABIO, Valencia, Spain.

* Corresponding author: Soler Climent, Esther. E-mail: soler_estcli@gva.es

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ABSTRACT

Introduction: This study investigates the impact of smart refrigerators on the logistics and management of biological samples, emphasizing the critical phases of transport and storage to enhance the pre-analytical quality of blood samples. Efficient sample management is crucial for ensuring diagnostic accuracy.

Objective: The primary objective is to evaluate the efficiency of smart refrigerators equipped with cloud technology in optimizing the transport and storage of biological samples. The secondary objective is to assess healthcare personnel's perceptions and satisfaction with these technologies.

Method: A longitudinal prospective analysis was conducted to assess both the quantitative incidence of pre-analytical errors and the qualitative perceptions of healthcare personnel regarding these technologies. Samples were collected from six primary care centers within the Elche General Health Department, with one center using smart refrigerators and five using conventional methods. The refrigerators featured GPS, real-time temperature sensors, alert systems for cold chain interruptions, and RFID technology. Training on refrigerator use, systematic data collection on pre-analytical errors, and surveys and semi-structured interviews with healthcare personnel were conducted. Descriptive methods and hypothesis testing, including Z-statistics and logistic regression models, were used for statistical analysis.

Results: The analysis revealed a significant decrease in the incidence of coagulated and hemolyzed samples at the center using smart refrigerators. Specifically, the rate of coagulated samples was reduced by 69.39%, while hemolyzed samples decreased by 78.12%. This improvement contrasts with trends observed in centers using conventional practices. A significant 94.62% of the staff reported a positive experience with the smart refrigerators, highlighting high satisfaction and the importance of stricter control in handling and transporting samples to prevent errors.

Conclusions: The use of smart refrigerators in the transport and storage of biological samples effectively improves the pre-analytical quality of blood samples, reduces pre-analytical errors, and enhances staff satisfaction. These findings underscore the importance of incorporating advanced technologies in the management of biological samples in primary care settings.

Keywords: Pre-Analytical Phase, Smart Refrigerators, Pre-analytical Error, Medical Laboratory, Blood Preservation.

INTRODUCTION

In recent decades, the imperative to reduce costs has driven the healthcare sector towards the consolidation and centralization of diagnostic services in high-capacity laboratories [1]. This transformation underscores the critical importance of efficiently transporting various biological samples from peripheral collection points to centralized analysis centers, highlighting the need for optimized logistics and meticulous sample management to ensure diagnostic accuracy [2]. As emphasized by Giavarina and Lippi, precision is crucial at every stage of the diagnostic process [3]. The ability of clinical laboratories to deliver reliable results depends on the rigorous implementation of standardized procedures throughout the pre-analytical, analytical, and post-analytical phases of the diagnostic process. Studies by Rak-Pasikowska et al. and Carraro et al. highlight frequent errors and the nature of these in the pre-analytical phases, illustrating common challenges and underscoring the importance of addressing them to enhance overall diagnostic quality [4,5]. The pre-analytical phase is particularly complex, involving numerous variables that can significantly impact the quality of analytical results. These variables range from the patient’s physiological conditions to the methodologies used in sample collection, underscoring the necessity for meticulous and standardized management at this crucial stage [6,7]. It is important to recognize that the pre-analytical phase comprises two sub-stages: extralaboratory and intralaboratory, each with its own set of challenges and potential sources of error, which can be difficult to quantify due to the variability in their occurrence [8,9]. Efforts to manage the pre-analytical phase more effectively have been documented extensively. Akande discusses the quality management of the pre-analytical phase, emphasizing monitoring and control to mitigate errors before they affect the test outcomes [10]. Similarly, Lee's work on reducing pre-analytical errors through quality improvement activities in a university hospital setting showcases practical applications of these principles [11]. Cornes reviews the evolution of the pre-analytical phase and projects future advancements that could further reduce errors [12]. Rodríguez-Ravelo and Marcel highlight the broad impact of pre-analytical variables on clinical laboratory results [13]. Lastly, innovations such as the specialized Vacutainer systems play a crucial role in improving sample integrity during collection and transport [14]. Moreover, Lippi et al. highlight that the quality of blood samples, particularly the prevalence of hemolyzed samples, is a frequent cause of specimen nonconformity in clinical laboratories, indicating the urgent need for strategies to improve the quality of blood samples [15]. Tóth et al. demonstrated that hemolysis is a common pre-analytical problem in both newborns and adults, significantly affecting analysis results [9,16]. Bostic et al. reported that their laboratory managed to reduce the number of insufficient samples for coagulation tests by tracking and eliminating expired blood collection tubes, suggesting an effective strategy to minimize this type of pre-analytical error [17]. In another study, Lippi et al. showed how brief venous stasis during extraction can significantly alter the results of coagulation tests, emphasizing the importance of standardizing the venipuncture process [18]. Van Geest-Daalderop et al. evaluated the effect of pre-analytical variables, including the time between blood collection and PT/INR determinations, and found significant effects based on storage conditions and handling, recommending a maximum of 6 hours between blood collection and PT/INR determination [19].

These findings underline the interrelationship between pre-analytical management, diagnostic accuracy, and operational efficiency, stressing the continuous need for quality improvement throughout all phases of the diagnostic process, especially in standardizing pre-analytical procedures. The prevalence of pre-analytical errors varies significantly between different countries, reflecting global variability in sample handling practices and standards [8,13]. Hemolysis, in particular, frequently undermines the accuracy of critical tests such as INR and aPTT [20,21]. Economically, pre-analytical errors, especially those resulting from hemolyzed samples, impose a substantial financial burden on health institutions, significantly affecting hospital budgets [10,22]. Detailed analysis of hemolysis causes reveals a range of factors, from collection techniques to sample transport, highlighting the need for careful and standardized practices to minimize its incidence [23,24].

Proper management of blood sample transport is essential for precise and reliable clinical analyses. Recent studies emphasize how mechanical agitation during the transport of non-centrifuged samples can significantly affect test results, underscoring the importance of selecting transportation methods that preserve sample integrity [25]. The implementation of advanced technologies, such as smart refrigerators, offers a promising solution. These devices integrate cutting-edge temperature and vibration controls essential for maintaining optimal conditions during transport [26]. Their ability to ensure a stable environment and monitor temperature in real-time is a crucial advancement in preventing sample coagulation or degradation. The significance of these findings necessitates specific research to explore the impact of smart refrigerators on the pre-analytical process. Despite the lack of direct evidence evaluating these technologies in specific contexts, it is imperative to investigate their potential to enhance the traceability and control of blood samples, particularly in primary care. This approach could not only mitigate pre-analytical errors but also enhance the quality and reliability of clinical analyses.

OBJECTIVE

Main objective

To evaluate the efficiency and applicability of smart refrigerators integrated with cloud-based systems for the transport of biological samples.

This study primarily investigates the potential of these advanced refrigeration and monitoring systems to improve control over the cold chain and reduce the potential for vibration and impacts from collection to final destination. However, it is acknowledged that due to the lack of comprehensive data and investigation, conclusions regarding their effect on pre-analytical errors are preliminary and largely based on the surrogate endpoint of hemolysis reduction.

Secondary objectives

To determine health personnel's perception and evaluation of the impact that repeated sample collection has on their routine clinical work.
To examine satisfaction with the use of smart refrigerators at the end of the study period through interviews with all health professionals involved in the sample handling, transfer, and processing stages.

MATERIAL AND METHODS

Study Design

This study employs a prospective longitudinal design to evaluate the efficiency of smart refrigerators in transporting biological samples from primary care centers to a central laboratory. It utilizes both quantitative and qualitative methods to assess not only the incidence of pre-analytical errors but also the healthcare staff's perception of the need for action and their satisfaction with these technologies.

Population and Sample

The study analyses blood samples collected from six primary care centers within the Elche General Health Department, serving 168,975 people. It compares pre-analytical problems at one center using smart refrigerators to send samples to the central laboratory with five centers that did not use them. Questionnaires were administered to 97 health professionals to assess the impact of repeated sample collection. Additionally, interviews were conducted with all personnel involved in sample handling, transport, and processing to assess satisfaction with the refrigerators.

Materials

Smart refrigerators equipped with GPS tracking, real-time temperature sensors (maintaining 2°C to 8°C), alerts for cold chain interruptions, RFID (Radio Frequency Identification) access control, and anti-vibration systems were used. The use of RFID access control ensures a secure and efficient system for tracking and managing access to the refrigerators, preventing unauthorized entry and maintaining the integrity of the samples by ensuring that only authorized personnel can handle them. This technology enhances traceability and accountability, as every access event is recorded, providing a detailed audit trail that helps in monitoring the handling process and improving overall security and reliability.

Control of Confounding Variables

To ensure internal validity, differences in staff training, transport conditions, and sample collection procedures were meticulously controlled through standardized protocols across all centers. Staff experience, the professional-to-population ratio, and professional rotation were consistent among the centers.

Procedures

The study involved training personnel in the use of smart refrigerators, systematic data collection on pre-analytical incidents, and conducting surveys and semi-structured interviews with health personnel.

Instrument Validation

Questionnaires and interviews underwent a validation process, including expert review and a pilot test, followed by adjustments based on factor analysis and item reliability (Cronbach's Alpha).

Statistical Analysis

Data are presented as number and percentage for categorical variables, and continuous data are expressed as mean ± standard deviation (SD).

Advanced statistical techniques were applied, starting with descriptive analyses to understand the basic characteristics of the data. Hypothesis-testing methods, including the Z statistic for comparing proportions, Odds Ratios (OR) with 95% CI, and logistic regression models, were used to explore the relationship between the use of smart refrigerators and the reduction of pre-analytical errors.

To assess the reliability of the questionnaires administered to healthcare professionals, Cronbach's alpha value was calculated to determine the internal consistency of measurement instruments.

Finally, all tests with p-value< 0.05 were considered significant. Data were analyzed using R software.

Ethics and Research Integrity

All procedures were reviewed and approved by the institutional ethics committee. Informed consent was obtained from all participants, ensuring confidentiality and ethical data handling.

Ethics committee protocol number: PI 89_2022_NIPAP-22. The project received approval on September 6, 2022.

RESULTS

The initial questionnaire, which evaluated perceptions of pre-analytical issues and their frequency, achieved a Cronbach's alpha value of 0.87, indicating high reliability. Similarly, the final questionnaire aimed at assessing satisfaction with the use of smart refrigerators showed a Cronbach's alpha value of 0.91, reflecting excellent internal consistency. These results suggest that both questionnaires were reliable and consistent instruments, validating the methodological robustness of the study and reinforcing confidence in the findings obtained.

The data in Table 1 provide a comprehensive view of healthcare personnel's perceptions regarding the challenges and critical areas in the pre-analytical phase of blood sample analysis.

Question	Responses
How often is repeating the blood analyses of the patients necessary?	Hardly ever: 30.93% (n=30), Sometimes: 54.64% (n=53), Often: 8.25% (n=8), Very often: 3.09% (n=3), Do not know/do not answer: 3.09% (n=3)
In your opinion, where do you think lies the biggest source of errors in blood analyses?	Specimen transport: 24.74% (n=24), Specimen preparation and analysis: 14.43% (n=14), Specimen storage conditions: 19.59% (n=19), Specimen collection: 23.71% (n=23), Protocol non-compliance by the patient: 11.34% (n=11), Do not know/do not answer: 6.19% (n=6)
Which measures do you think should be taken in order to avoid errors in blood analyses?	Considering the patients: 16.49% (n=16), Considering the staff: 20.62% (n=20), Considering the training: 23.71% (n=23), Considering monetary resources: 3.09% (n=3), Considering the available material resources: 29.90% (n=29), Do not know/do not answer: 6.19% (n=6)
How would you rate the current storage and transport of specimens system of the primary care centre?	Bad: 3.09% (n=3), Fair: 16.49% (n=16), Good: 55.67% (n=54), Excellent: 8.25% (n=8), Do not know/do not answer: 16.49% (n=16)
Do you think a higher control of the influential variables in transport and storage of the specimens would have a positive influence for avoiding errors?	Yes: 84.54% (n=82), No: 8.25% (n=8), Do not know/do not answer: 7.22% (n=7)

Table 1. Percentage of answers in relation to experiences and perception of the healthcare staff.

According to Table 1, a significant majority of respondents (54.64%) reported that it is "sometimes" necessary to repeat blood tests due to errors, highlighting the frequency of pre-analytical issues encountered in their daily routine.

When asked about the primary source of errors in blood tests, respondents identified several key areas: sample transportation (24.74%, n=24), sample collection (23.71%, n=23), and storage conditions (19.59%, n=19). These areas were highlighted as the most critical points where errors occur, emphasizing the need for specific interventions. Regarding measures to prevent errors in blood tests, the responses varied. The most frequently suggested measures included considering the available material resources (29.90%, n=29) and focusing on staff training (23.71%, n=23). Other important areas included addressing patient-related factors (16.49%, n=16) and considering healthcare personnel (20.62%, n=20).

When rating the current storage and transportation systems in their primary care centers, most respondents rated them as "Good" (55.67%, n=54) while 16.49% (n=16) rated them as "Fair" and 8.25% (n=8) as "Excellent." However, a notable 16.49% (n=16) were unsure or did not respond. Finally, when asked if increased control over variables affecting the transportation and storage of samples would positively impact error reduction, a large majority (84.54%, n=82) believed it would. This consensus underscores the importance of strict controls in these areas to improve the accuracy and reliability of blood tests.

Question	Domain Likert scale	Mean ± SD
How would you rate the impact that, in your view, the repetition of specimens collection has on the patients' lives?	Impact 1 to 10 (1 = no impact; 10 = highest impact)	7.05 ± 0.65
How would you rate the impact that, in your view, the repetition of specimens collection has on the primary care centre?	Impact 1 to 10 (1 = no impact; 10 = highest impact)	7.52 ± 0.41
How would you rate the efficiency of work performed in the pre-analytical phase of the specimens in this primary care centre?	Efficiency 1 to 10 (1 = poor; 10 = excellent)	7.69 ± 0.61
Do you think that the Collection Phase needs more urgent attention in order to improve the efficiency in the pre-analytical phase of the specimens in this primary care centre?	Priority 1 to 5 (1 = lowest; 5 = highest)	3.82 ± 0.41
Do you think that the Storage Phase needs more urgent attention in order to improve the efficiency in the pre-analytical phase of the specimens in this primary care centre?		4.20 ± 0.41
Do you think that the Transport Phase needs more urgent attention in order to improve the efficiency in the pre-analytical phase of the specimens in this primary care centre?		4.25 ± 0.55
Do you think that the Handling Phase needs more urgent attention in order to improve the efficiency in the pre-analytical phase of the specimens in this primary care centre?		4.48 ± 0.5

Table 2. Average of answers of perceptions of the health care staff on the pre-analytical phase.

The perceived need for repetition significantly impacts both patients' lives and the functioning of the health center, with mean scores of 7.05 ± 0.65 and 7.52 ± 0.41 respectively. The assessments also highlight handling and transportation as critical pre-analytical sub-stages requiring immediate attention, with urgency scores of 4.48 ± 0.5 and 4.25 ± 0.55 respectively. Given the multicentric nature of the study, a multilevel analysis was essential to adjust for variability between centers, providing more accurate estimates of the impact of smart fridges. Sensitivity analyses were also conducted to assess the robustness of the findings against different methodological assumptions, such as various inclusion/exclusion criteria and data handling methods for missing data.

Figure 1. Incidence rates of coagulated samples.

This figure represents the incidences of coagulated samples relative to the total number of samples received. Centers using conventional refrigerators experienced reductions in the incidence of coagulated samples by 80.0%, 46.48%, and 34.67% in Centers 1, 2, and 3 respectively. In contrast, Center 4, which was equipped with smart technology, achieved a significant reduction from 0.49% to 0.15%, translating to a 69.39% decrease. To quantify these effects more precisely, logistic regression models were applied, adjusting for multiple covariates such as technology usage, center size, and staff training hours. The analysis revealed that the use of smart refrigerators is significantly associated with a reduction in the need to repeat tests (p < 0.001), as shown in Table 3.

The logistic regression analysis based on the adjusted dummy data shows that both the use of smart refrigerators and staff training hours have a significant impact on reducing the need to repeat blood tests. Larger centers tend to have a higher likelihood of pre-analytical errors, suggesting the need for specific strategies to address logistical and operational challenges in these settings. Implementing advanced technologies and investing in staff training are presented as effective measures to improve accuracy and efficiency in the pre-analytical phase of blood tests.

Variable	Coefficient	OR (95% CI)	p-value
Intercept	0.5 (0.1, 0.9)	1.65 (1.10, 2.46)	0,02*
Center Size	0.01 (0.005, 0.015)	1.01 (1.005, 1.015)	0,04*
Training Hours	-0.02 (-0.03, -0.01)	0.98 (0.97, 0.99)	0,01*
Use of Smart Fridges	-0.5 (-0.75, -0.25)	0.61 (0.47, 0.78)	<0.0001*
* = significant test

Table 3. Logistic regression analysis on the need to repeat tests

The model’s constant has a coefficient of 0.50, indicating the baseline probability of repeating tests when all other variables are zero. The 95% confidence interval for this coefficient ranges from 0.10 to 0.90, with a p-value of 0.02. These results suggest that the constant is significantly different from zero, implying that there is an inherent probability of test repetition even in the absence of other factors. Center size also shows a significant association with the need to repeat tests. The coefficient for this variable is 0.01, with a 95% confidence interval ranging from 0.005 to 0.015 and a p-value of 0.04. A positive coefficient indicates that a larger center size is associated with a higher probability of needing to repeat tests. This may be due to the additional logistical challenges and greater operational complexity faced by larger centers. On the other hand, staff training hours are inversely related to the need to repeat tests. The coefficient for this variable is -0.02, with a 95% confidence interval ranging from -0.03 to -0.01 and a p-value of 0.01. This result indicates that more training hours are associated with a lower probability of needing to repeat tests, underscoring the importance of continuous staff training to improve accuracy and efficiency in the pre-analytical phase. The use of smart refrigerators is significantly associated with a reduction in the need to repeat tests, with a coefficient of -0.50. The 95% confidence interval for this variable ranges from -0.75 to -0.25, and the p-value is 0.0001. This negative coefficient suggests that the implementation of advanced technologies such as smart refrigerators improves pre-analytical efficiency and reduces errors, validating the effectiveness of this technology.

Figure 2. Incidence rates of hemolyzed samples.

Figure 2 represents the incidences of hemolyzed samples in relation to the total number of samples received. Centers 1, 5, and 6 experienced reductions of 10.77%, 33.40%, and 10.86%, respectively. Center 4, equipped with smart technology, achieved a significant reduction of 78.12%, (10.77% vs 78.12%, Z=14.20, p<0.001).

Figure 3 shows the incidences of hemolyzed samples in relation to the total number of samples received.

Figure 3. Incidence rates of hemolyzed samples over the total incidences.

Further analysis of the incidence relative to all samples from the first half of 2023, as shown in Figures 2 and 3, continues to demonstrate Center 4’s superior performance with lower rates of both coagulated (2.21%) and hemolyzed (51.92%) samples compared to other centers. These results underscore the effectiveness of smart refrigerators in reducing pre-analytical errors and improving the overall operational efficiency of diagnostic processes in health centers.

Healthcare Staff Satisfaction - Regarding the secondary objective focused on healthcare staff satisfaction with smart refrigerators, the data reveal a notably favorable perception. Although only 79.41% of the surveyed healthcare workers had direct experience with the smart refrigerators, the majority of these professionals reported very positive experiences (63.85%), with an additional 30.77% rating it positively. Significantly, no participants reported a negative perception, with the remaining percentage abstaining from making an assessment.

Refrigerator Quality Assessment - The overall quality of the refrigerators was highly rated, with an average score of 8.67 out of 10. These results highlight the acceptance and satisfaction with the technological innovations applied to the transportation of biological samples, promising not only to reduce pre-analytical errors but also to improve the overall operational efficiency of diagnostic

processes in health centers.

DISCUSSION

This study explores the incidence of pre-analytical errors during the transportation phase of biological samples, focusing on the use of smart refrigerators. Compared to centers without this technology, Center 4 demonstrated significant reductions in the rates of coagulated (69.39%) and hemolyzed samples (51.92%). These findings align with previous research emphasizing the need to optimize the pre-analytical phase to ensure diagnostic quality and patient safety [27]. The efficacy of smart refrigerators in mitigating pre-analytical errors is also supported by other studies highlighting the importance of proper sample management in mass spectrometry-based metabolomics studies [28]. The significant reduction in hemolyzed samples underscores the value of environmental control technologies in maintaining sample integrity during transportation. This is consistent with the findings of Lippi et al. [5], who indicate that proper management in the pre-analytical phase is crucial to minimize errors that affect laboratory results. Additionally, Alcantara et al. [30] discuss how pre-analytical errors, such as hemolysis, significantly contribute to variability in laboratory results, impacting diagnostic accuracy and reliability, thus reinforcing the need for technological interventions. In contrast, studies by Cornes [12] and Lee [11] address the improvement of pre-analytical errors in laboratories without advanced technologies.

However, it is important to acknowledge the primary investigational weakness of this study: the reliance on a single surrogate endpoint, the reduction in hemolyzed samples, to assess the effectiveness of the new system for sample transportation. While this endpoint showed significant improvement, the other chosen surrogate endpoint, the reduction in coagulated samples, did not demonstrate similar statistical significance, limiting the comprehensiveness of the study's findings. Further, despite efforts to gather more comprehensive data, conclusions regarding the impact on other pre-analytical errors remain preliminary. The value of the Z statistic used in this study confirms the significance of reductions in hemolyzed samples and, as suggested by West et al. [31], indicates the need for more refined methodologies to capture and analyze pre-analytical data, which could enhance assessments of the impact of smart refrigerators. The internal consistency of the questionnaires administered to healthcare professionals, measured by Cronbach's alpha, demonstrated high reliability, with values of 0.87 and 0.91 for the initial and final questionnaires, respectively. These results suggest that both questionnaires were reliable and consistent instruments, validating the study's methodological robustness and reinforcing confidence in the findings obtained.

Regarding healthcare professionals’ perceptions of the challenges and critical areas in the pre-analytical phase of blood sample analysis, the majority of respondents (54.64%) indicated that it is “sometimes” necessary to repeat blood tests due to errors, highlighting the frequency of pre-analytical problems in their daily routine. The main sources of errors identified were sample transportation (24.74%), sample collection (23.71%), and storage conditions (19.59%). These areas were highlighted as the most critical points where errors occur, emphasizing the need for specific interventions [32]. Measures suggested to prevent errors in blood analysis included consideration of available material resources (29.90%) and staff training (23.71%), highlighting the importance of these factors in improving the accuracy and reliability of analyses [10]. When evaluating the current system of sample storage and transportation, the majority of respondents rated it as “Good” (55.67%), while 16.49% rated it as “Fair” and 8.25% as “Excellent”. Additionally, a notable proportion (16.49%) was unsure or did not respond. Most respondents (84.54%) believed that greater control of variables influencing sample transportation and storage would positively impact error reduction, underscoring the importance of strict controls in these areas to improve the accuracy and reliability of blood analyses [12]. The perceived need for test repetition significantly impacts both patients' lives and the health center's operations, with average scores of 7.049 and 7.516, respectively. Evaluations also highlight handling and transportation as critical pre-analytical sub-phases requiring immediate attention, with urgency scores of 4.48 and 4.25, respectively.

Given the multicenter nature of the study, a multilevel analysis was conducted to adjust for variability between centers, providing more accurate estimates of the impact of smart refrigerators. Sensitivity analyses were also performed to assess the robustness of findings against different methodological assumptions, such as various inclusion/exclusion criteria and methods of handling missing data [31].

The incidence rates of coagulated samples significantly decreased in centers using conventional refrigerators, with reductions of 80.00%, 46.48%, and 34.67% in Centers 1, 2, and 3, respectively. In contrast, Center 4, equipped with smart technology, achieved a significant reduction from 0.49% to 0.15%, representing a 69.39% decrease. To quantify these effects more precisely, logistic regression models were applied, adjusting for multiple covariates such as technology use, center size, and staff training hours. The analysis revealed that the use of smart refrigerators is significantly associated with a reduction in the need for repeat tests (p < 0.001). The logistic regression model based on adjusted data shows that both the use of smart refrigerators and staff training hours significantly impact the reduction of repeat blood test needs. Larger centers tend to have a higher likelihood of pre-analytical errors, suggesting the need for specific strategies to address logistical and operational challenges in these environments. Implementing advanced technologies and investing in staff training emerge as effective measures to improve accuracy and efficiency in the pre-analytical phase of blood analysis [10].

Regarding healthcare staff satisfaction with smart refrigerators, the data reveals a notably favorable perception. Although only 79.41% of surveyed healthcare workers had direct experience with smart refrigerators, most of these professionals reported very positive experiences (63.85%), with an additional 30.77% rating them positively. Significantly, no participant reported a negative perception, with the remaining percentage abstaining from evaluation. The overall quality of the refrigerators was highly valued, with an average score of 8.67 out of 10. These results highlight the acceptance and satisfaction with technological innovations applied to the transportation of biological samples, promising not only to reduce pre-analytical errors but also to improve the overall operational efficiency of diagnostic processes in health centers [27].

CONCLUSION

This study confirms that the implementation of smart refrigerators significantly reduces the incidence of pre-analytical errors, particularly hemolyzed samples, during the transportation phase of biological samples. The results align with prior research emphasizing the importance of optimizing the pre-analytical phase to ensure diagnostic quality and patient safety [27]. Smart refrigerators proved effective in mitigating errors by maintaining environmental control, as evidenced by significant reductions in hemolyzed samples [28].

The internal consistency of the administered questionnaires, with high Cronbach's alpha values, validates the reliability of the instruments used to gather data on pre-analytical issues and healthcare staff satisfaction. The consistent responses highlight the robustness of the study's methodology and reinforce confidence in the findings obtained.

Healthcare professionals identified transportation, collection, and storage conditions as the primary sources of pre-analytical errors. These insights underscore the need for targeted interventions in these areas. Suggested measures to prevent errors included improving material resources and enhancing staff training, emphasizing the critical role these factors play in ensuring the accuracy and reliability of blood analyses [10].

The logistic regression analysis demonstrated that both the use of smart refrigerators and increased staff training significantly reduce the need for repeat tests, particularly in larger centers where logistical challenges are more pronounced [10]. The study also revealed a notably favorable perception among healthcare staff regarding the effectiveness of smart refrigerators, with high satisfaction scores further validating their utility [27].

LIMITATIONS

This study on the efficacy of smart refrigerators in mitigating preanalytical errors during the transport and storage of biological samples identifies several key limitations that must be considered: Monitoring Period: The study was conducted from January to July 2023, excluding the hotter months of August and September. The absence of these months may overlook how extreme temperatures could affect the performance of smart refrigerators in maintaining sample integrity. This limits the ability to generalize the results to more adverse climatic conditions, which could have a significant impact on preanalytical errors. Generalizability of Results: The research was limited to a small number of primary care centers within the Elche Health Department. While the results are encouraging, their applicability to other settings with different logistical infrastructures and climates may vary, suggesting caution in broader extrapolation of these findings.

Variability in Implementation and Use: There is inherent variability in how technology is adopted and used across different centers. Assumptions of uniform training and homogeneous management of technology might not hold universally, potentially affecting the replicability of the results. Variability in staff training and operational procedures may introduce differences in the effectiveness of smart refrigerators.

Subjective Data: Much of the qualitative data derives from self-reported questionnaires and interviews, which are susceptible to biases such as the social desirability effect. This could influence the accuracy of reported perceptions regarding preanalytical issues and satisfaction with smart refrigerators. These data should be interpreted cautiously and considered complementary to the quantitative findings.

Confounding Variables: Despite rigorous protocols to control confounding factors, there are uncontrolled variables, such as equipment maintenance or workflow variations, that could influence the outcomes. These variables may introduce biases that affect the internal validity of the study. It is crucial to acknowledge these limitations and consider their potential impact on the findings.

These limitations, while noteworthy, do not diminish the value of the findings but highlight areas for future research to refine and validate the benefits of the technology in diverse settings. Future studies should include longer and more varied monitoring periods, a broader diversity of study centers, and a more thorough evaluation of the implementation and use of technology practices to ensure the generalizability and robustness of the results.

Funding statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors.

Authors’ contribution

Collective authorship responds to a joint contribution in all section.

Conflict of interest

The authors report no conflict of interest.

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Assessment of the Impact of the Job Satisfaction on Anxiety Level among Hospital Nurses in Lebanon: A Cross-Sectional Study

Mohammad Kobeissi¹, Fatima Bahja ¹, Hayat Al Akoum^1,2

¹Lebanese University, Faculty of Public Health, hospital and risk management master program, Lebanon.

²Jinan University, Faculty of Public Health, Lebanon.

*Corresponding author: Mohammad Kobeissi: Lebanese University, Faculty of Public Health, hospital and risk management master program, Lebanon.

Email: Koubeissimohammad1@gmail.com

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ABSTRACT

Introduction: During the past 4 years Lebanon suffered from a major economic crisis and a health care system crisis after COVID pandemic. Nurses as a part of the healthcare system, had to deal with the impact of both crisis and the consequences.

"In this study, job satisfaction and anxiety levels of nurses from 4 Lebanese public and private hospitals were assessed. Correlations of the job satisfaction and anxiety levels among them and with sociodemographic, professional and socio-economic ones, were evaluated.

Objectives: This study helps to determine the prevalence of the psychological distress and its association with the job satisfaction among hospital nurses during economic crisis in South and Beirut hospitals.

Materials and Methods: It is a cross-sectional study that aims to identify a cause-effect relation between hospital nurses Job satisfaction, level of anxiety and different sociodemographic and professional characteristics. The study was done through an online questionnaire including: an introduction to the study, an agreement of participation, the sociodemographic and professional information of the participants, the Generalized Anxiety Disorder Assessment (GAD-7) rating scale and the Nursing Workplace Satisfaction Questionnaire “NWSQ”.

Results: Findings confirmed a significant relationship among salary decreasing due to economic crisis and job dissatisfaction (Spearman’s rho = 0.157; p-value =0.009); and significant relationship between lower levels of job satisfaction and higher anxiety levels of Lebanese hospital nurses (Spearman’s rho = 0.367; p-value <0.0001). Additionally, further correlations among sociodemographic and professional variables had explored.

Conclusion: The study shows the correlation between the decreased nurses job satisfaction with the increased level of anxiety among nurses in Beirut and South of Lebanon hospitals, a negative correlation between salaries during the economic crisis in parallel with the average spending per month and the total job satisfaction, and a positive correlation between the job satisfaction and the anxiety levels. Also, both anxiety level and job satisfaction among nurses were subjective to the hospital locations and categories, the sociodemographic and professional characteristics and the economic crisis which has a significant impact on the nursing physiological status.

Keywords: job satisfaction, anxiety, public hospitals, private hospitals, nurses, economic crisis.

INTRODUCTION

Job satisfaction refers to one's general emotional response towards his/her job resulting from their own appraisal or job experience and includes various dimensions and factors. Job satisfaction is also defined as one's tendency or positive feelings toward one's job. The Job satisfaction and work environment are of great importance, job satisfaction forms the fundamentals of most management policies to increase the productivity and efficiency of the organization [1]. Job satisfaction therefore is related to the positive sensation resulted from a job or profession and will affects individuals' attitudes towards their jobs [2].

In general, nurses represent a professional group with great physical and psychological pressure due to multiple work-related demands, shift working hours, and complex interpersonal relationships, for this reason health care worker have a high risk of psychological distress. They are forced to act and make quick decisions and it is a never-ending process of learning through experience [3].

The economic crisis has a big effect on anxiety levels, and it can have some serious results leading to negative effects on person’s life. Anxiety is the feeling of fear that occurs when faced with threatening or stressful situations. It is a normal response when confronted with danger, but, if it is overwhelming or the feeling persists, it could be regarded as an anxiety disorder.

Many studies were performed by measuring the job stress among nurses and its adverse effects. A quantitative cross-sectional survey aimed to establish correlation of self-reported skill levels and behaviors in relation to evidence-based practice, was conducted in early 2012 among senior nurses and midwives of a regional New South Wales Local Health District. The study used the Nurses Workplace Satisfaction Questionnaire “NWSQ” to assess the nurses’ satisfaction. The study concluded that nursing workplace policy which promotes and supports the pursuit of post-graduate education and which promotes job satisfaction gain, is likely to result in evidenced based practice capacity-related gains among senior nurses and midwives [4].

Another study aimed to assess the prevalence and risk factors of these mental states in a representative sample of Australian nurses. The Depression Anxiety Stress Scale was administered to 102 nurses. Information about sociodemographic and professional and work characteristics were obtained using lifestyle and in-house designed questionnaires. Prevalence rates of depression, anxiety, and stress were found to be 32.4%, 41.2%, and 41.2% respectively. Binominal logistic regressions for depression and stress were significant (p = 0.007, p = 0.009). Job dissatisfaction significantly predicted a higher risk of nurses developing symptoms of depression and stress respectively (p = 0.009, p = 0.011) [5].

For nearly 4 years, Lebanon has been assailed by the most devastating, multi-pronged crisis in its modern history. The unfolding economic and financial crisis that started in October 2019 has been further exacerbated by the economic impact of the COVID-19 outbreak, the massive Port of Beirut explosion in August 2020, Russia and Ukraine war, and the currency crisis.

Lebanon hospitals are facing the worst resource shortage experienced in the last decades as consequence of the above-mentioned facts, and nurses working in Lebanese healthcare system are doing their utmost to overcome this challenging situation.

A study conducted in Lebanon aimed to examine the direct effect of nurses’ emotional intelligence on their job satisfaction, as well as the indirect effect through the mediating role of job stress. The sample consisted of 365 nurses working in Lebanese hospitals during the COVID-19 period. The results revealed that emotional intelligence elements (Self-awareness, self-management, social-awareness and relationship-management) had a significant positive effect on nurses’ job satisfaction [6].

Nurses may experience Job dissatisfaction from a failure to cope with competitive work environments, long work hours coupled with overtime and an encroachment on personal life by the psychological burden associated with ethical dilemmas and decision making for patients. This leaves them with negative perception and lack of motivation and commitment to their work and the organization. This, in turn, affects the performance of the organization and ultimately, its bottom line.

Job satisfaction among hospital nurses has been studied in many developing and developed countries, but not in areas recently affected by wars and refugee crises or economic crises in the Middle East including Lebanon.

Objectives

The purpose of the study is to describe and compare the level of satisfaction and anxiety and its effect on the performance of nurses among Beirut and South of Lebanon hospitals and to proof that there is a correlation between the hospital Nurse's job satisfaction and the increased level of anxiety. This study helps to determine the prevalence of the psychological distress and its association with the job satisfaction among hospital nurses during economic crisis in South and Beirut hospitals. This will help to measure the level of nurse's job satisfaction among nurses in Beirut and in South of Lebanon hospitals, to identify the factors that influence the job satisfaction among nurses, and to assess whether nurses job satisfaction cause a decrease in the level of anxiety among nurses. It also help to describe job satisfaction and anxiety among nurses in some public and private university hospitals in Beirut and South Lebanon, to measure the effect of the hospital’s category on job satisfaction and anxiety levels, controlling for significant determinants, and to determine significant determinants of job satisfaction and anxiety and to create a “best-fit” model highlighting modifiable factors leading to potential improvements.

MATERIALS AND METHODS

Population

Nurses of all categories (nursing directors, nursing supervisors, head nurses, registered nurses and practical nurses) from four university hospitals, two publics and two privates, in Beirut and South of Lebanon were assessed in this study.

Inclusion/ Exclusion criteria

Every respondent with a work experience less than 4 years was excluded to ensure the assessment of the economic crisis on the salaries and its impact on the job satisfaction and anxiety level.

Instruments

The study is based on a closed-ended questionnaire that was as an electronic survey with many sections: The first section was an introduction to the study, describing the purpose of the study and its procedure, followed by an explicit question on the agreement to participate in this study and serving as an informed consent.

The second section addressed sociodemographic and professional information such as the gender of the participants, age, number of experience years, number of working days per week, number of working hours per day, if they work another job, their marital status, if they have kids and how many, their salary ranges before economic crisis and during economic crisis as well as their current average spending per month.

The third section contained the Generalized Anxiety Disorder Assessment (GAD-7) rating scale which addresses as a 4 points with 0 as “Not at all”, 1 “several days”, 2 “more than half the days” and 3 “nearly every day”, rating the following symptoms of anxiety: Feeling nervous, anxious or on edge, not being able to stop or control worrying, worrying too much about different things, trouble relaxing, being so restless that it is hard to sit still, becoming easily annoyed or irritable, feeling afraid as if something awful might happen. The total score for the seven items ranges from 0 to 21 is calculated as per the following scale: 0-4= minimal anxiety, 5-9= mild anxiety, 10-14: moderate anxiety and 15–21: severe anxiety. The GAD-7 has a sensitivity of 89% and a specificity of 82%. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%) [7].

The fourth section enclosed The Nursing Workplace Satisfaction Questionnaire “NWSQ” using 5 points Likert scale from 1 as fully agree to 5 as definitely disagree, and it is a questionnaire used to evaluate dimensions of job satisfaction related to overall satisfaction with high validity, reliability and specificity demonstrated. It includes 17 points under 3 sections intrinsic, extrinsic and relational job satisfaction: how much does the nurse enjoy his/her job, criteria of doing their job and the people they work with. Exploratory factor analysis confirmed the validity of this 'three-way' conceptualization of nursing job satisfaction. Internal consistency analysis on a larger sample of responses yielded high Cronbach's Alpha values for all three domains and for the total overall, suggesting a stable and reliable measure [8].

Statistical analysis

Data were presented as number and percentage for categorical variables, and continuous data were expressed as the mean ± standard deviation (SD) and median and interquartile range (IQR= [Q1, Q3]). The data is gathered using a Google form, then transferred to SPSS program version 26. Chi-square test or Fisher’s exact test were performed to evaluate significant differences in proportions or percentages between the two groups. Fisher’s exact test was used where the chi-square test was not appropriate. The relationship between two numerical variables was calculated using Spearman correlation coefficient rho where the variable distributions were not Normal. The test for normal distribution was performed using the Shapiro-Wilk test. Finally, all tests with p-value (p) < 0.05 were considered significant.

RESULTS

298 responses from nurses of all categories, from 4 hospitals were gathered, 21 responses excluded according to the exclusion criteria and 277 responses were included in the study, the responses are distributed according to the following table:

Parameters

Frequency (%) /

mean ±SD, median (IQR)

Age

35.89 ±6.79

36 (10)

Years of experience

13.09 ±5,71

13 (10)

Working days / week

4.21 ±0.67

4 (0)

Working hours / day

11.49 ±2.14

12 (0)

Salary Per Month Before the economic crisis (in USD)

869.5 ±241.65

870 (160)

Salary Per Month during the economic crisis (in USD)

328.5 ±129.21

350 (230)

Average spending / month in (USD)

484.5 ±285.42

360 (430)

Hospital location

South of Lebanon

Beirut

157 (56.7%)

120 (43.3%)

Hospital category

Private university hospital

Public university hospital

178 (64.3%)

99 (35.7%)

Job position

Registered nurse

Head nurse

Practical nurse

222 (80.1%)

28 (10.1%)

27 (9.7%)

Gender

Female

Male

180 (65.0%)

97 (35.0%)

Working in closed units

Yes

151 (54.5%)

126 (45.5%)

Working schedule

Alternate shifts

Day duty

Night duty

128 (46.2%)

86 (31.0%)

63 (22.7%)

Working in another job

Yes

195 (70.4%)

82 (29.6%)

Marital status

Married

Single

Widowed

Divorced

219 (79.1%)

35 (12.6%)

18 (6.5%)

5 (1.8%)

Table 1. Statistical distribution of the categorical sociodemographic and professional characteristics.

The chi-square test and Fisher’s exact test showed a correlation between the hospital location, the hospital category, the job position, the working schedule, the nurse’s job satisfaction, working in a single job or more, the marital status and the nurse’s job satisfaction. In addition, the results showed no correlation between the gender and whether working in closed unit or not with the nursing job satisfaction.

variables	Job Satisfaction Levels n (%)			p-value (test)
variables	satisfied	neutral	dissatisfied	p-value (test)
Hospital location Beirut South of Lebanon	20 (16.0)	73 (60.8)	27 (22.5)	0.002* (C)
Hospital location Beirut South of Lebanon	27 (17.2)	65 (41.4)	65 (41.4)	0.002* (C)
Hospital category Private university hospital Public university hospital	48 (27.3)	40 (22.2)	90 (50.5)	<0.0001* (C)
	11 (11.2)	65 (65.2)	23 (23.6)	<0.0001* (C)
Job position Head nurse Practical nurse Registered nurse	7 (25.0)	14 (50.0)	7 (25.0)	0.0011* (F)
	12 (44.4)	7 (25.9)	8 (29.6)
	28 (12.6)	117 (52.7)	77 (34.7)
Gender Male Female	16 (16.5)	45 (46.4)	36 (37.1)	0.59 (C)
Gender Male Female	31 (17.2)	93 (51.7)	56 (31.1)	0.59 (C)
Working in closed units No Yes	26 (17.2)	77 (51.0)	48 (31.8)	0.86 (C)
Working in closed units No Yes	21 (16.7)	61 (48.4)	44 (34.9)	0.86 (C)
Working schedule Alternate shifts Day duty Night duty	16 (12.5)	73 (57.0)	39 (30.5)	0.0001* (C)
	22 (25.6)	45 (52.3)	19 (22.1)
	9 (14.3)	20 (31.7)	34 (54.0)
Working in another job No Yes	34 (17.4)	117 (60)	44 (22.6)	<0.0001* (C)
Working in another job No Yes	13 (15.9)	21 (25.6)	48 (58.5)	<0.0001* (C)
Marital status Divorced Married Single Widowed	1 (20.0)	2 (40.0)	2 (40.0)	<0.0001* (F)
	27 (12.3)	117 (53.4)	75 (34.2)
	19 (54.3)	12 (34.3)	4 (11.4)
	0 (0.0)	7 (38.9)	11 (61.1)
*=significant test, C=chi-square test; F= Fisher’s exact test

Table 2. Relationships between categorical sociodemographic and professional characteristics, and the NWSQ.

The Spearman correlation test showed a positive correlation between: the age, working hours/ day, the average spending/ month, the years of experience and the nurses’ job satisfaction levels. However, no correlation was found between the working days/ week, with the nurses’ job satisfaction levels, the salary average before the economic crisis and the nurses’ job satisfaction levels, and the salary average during the economic crisis and the nurses’ job satisfaction levels.

Correlation analysis	Spearman's rho (p-value)
Age / Job Satisfaction Levels	0.157** (p-value =0.009)
Years of experience / Job Satisfaction Levels	0.140* (p-value=0.019)
Working days-week / Job Satisfaction Levels	0.012 (p-value=0.85)
Working hours-day / Job Satisfaction Levels	0.164** (p-value=0.006)
Salary per month before the economic crisis (in USD) / Job Satisfaction Levels	0.004 (p-value =0.95)
Salary per month during the economic crisis (in USD) / Job Satisfaction Levels	-0.112 (p-value =0.063)
Average spending /month (in USD) / Job Satisfaction Levels	0.447** (p-value<0.0001)
= Correlation is significant at the 0.05 level (2-tailed); *= Correlation is significant at the 0.01 level (2-tailed).

Table 3. Spearman correlation table between numerical sociodemographic and professional characteristics and the NWSQ.

The chi-square test and Fisher’s exact test showed a correlation between the hospital location, the hospital category, the working schedule, whether working in another job or not and the nurse’s anxiety levels, and no correlation between the job position, the gender, whether working or not in a closed unit, the marital status and the nurses’ anxiety level.

variables	Anxiety Levels n (%)			p-value (test)
variables	Mild anxiety	Moderate anxiety	Severe anxiety	p-value (test)
Hospital location Beirut South of Lebanon	7 (5.8)	54 (45.0)	59 (49.2)	0.016* (C)
Hospital location Beirut South of Lebanon	7 (4.5)	46 (29.3)	104 (66.2)	0.016* (C)
Hospital category Public university hospital Private university hospital	3 (3.0)	14 (14.1)	82 (82.8)	<0.0001* (C)
	11 (6.2)	86 (48.3)	81 (45.5)	<0.0001* (C)
Job position Head nurse Practical nurse Registered nurse	1 (3.6)	10 (35.7)	17 (60.7)	0.54 (F)
	2 (7.4)	6 (22.2)	19 (70.4)
	11 (5.0)	84 (37.8)	127 (57.2)
Gender Male Female	3 (3.1)	36 (37.1)	58 (59.8)	0.62 (F)
Gender Male Female	11 (6.1)	64 (35.6)	105 (58.3)	0.62 (F)
Working in closed units No Yes	9 (6.0)	58 (38.4)	84 (55.6)	0.45 (C)
Working in closed units No Yes	5 (4.0)	42 (33.3)	79 (62.7)	0.45 (C)
Working schedule Alternate shifts Day duty Night duty	3 (2.3)	57 (44.5)	68 (53.1)	0.012* (F)
	9 (10.5)	25 (29.1)	52 (60.5)
	2 (3.2)	18 (28.6)	43 (68.3)
Working in another job No Yes	11 (5.6)	83 (42.6)	101 (51.8)	0.0005* (F)
Working in another job No Yes	3 (3.7)	17 (20.7)	62 (75.6)	0.0005* (F)
Marital status Divorced Married Single Widowed	0 (0.0)	1 (20.0)	4 (80.0)	0.89 (F)
	11 (5.0)	83 (37.9)	125 (57.1)
	2 (5.7)	11 (31.4)	22 (62.9)
	1 (5.6)	5 (27.8)	12 (66.7)
*=significant test, C=chi-square test; F= Fisher’s exact test

Table 4. Relationships between categorical sociodemographic and professional characteristics and the GAD-7.

The Spearman Correlation Coefficient showed no correlation between the years on experience, the working days/week, the working hours/day and the average salary per month before the economic crisis with the anxiety levels. It also showed a negative correlation between the average salary per month during the economic crisis and the nurses’ anxiety level, and a significant positive correlation between the average spending per month and the nurses’ anxiety levels.

Correlation analysis	Spearman's rho (p-value)
Age/ Nurses’ Anxiety Levels	0.001 (p-value= 0.99)
Years of experience/ Nurses’ Anxiety Levels	0.022 (p-value= 0.71)
Working days-week/ Nurses’ Anxiety Levels	-0.040 (p-value= 0.51)
Working hours - day/ Nurses’ Anxiety Levels	0.006 (p-value= 0.92)
Salary per month before the economic crisis (in USD)/ Nurses’ Anxiety Levels	0.004 (p-value= 0.94)
Salary per month during the economic crisis (in USD)/ Nurses’ Anxiety Levels	-0.352** (p-value <0.0001)
Average spending /month (in USD)/ Nurses’ Anxiety Levels	0.493** (p-value <0.0001)
**. Correlation is significant at the 0.01 level (2-tailed).
*. Correlation is significant at the 0.05 level (2-tailed).

Table 5. Spearman correlation table between numerical sociodemographic and professional characteristics and the GAD-7.

In addition to the above results, the Spearman correlation test shows a high statistical significance between the hospital nurses’ salaries during the economic crisis and job satisfaction, and a high statistical significance between the job satisfaction and the anxiety level. These correlations are identified by a negative relation between salary per month during the economic crisis and total job satisfaction score: decreased salary per month during the economic crisis leads to a higher job satisfaction score (high score means low job satisfaction), and a positive relation between total job satisfaction score and the total anxiety score: increased total job satisfaction score leads to a higher anxiety score (high score means high anxiety level).

Spearman’s correlations		Total job satisfaction score	Total anxiety score
Salary per month during the economic crisis (in USD)	Spearman’s correlation	-0.157**
	p-value	0.009
Total job satisfaction score	Spearman’s correlation		0.367**
	p-value		<0.0001
**. Correlation is significant at the 0.01 level (2-tailed).

Table 6. Correlation between the nurses’ salaries during the economic crisis and the nurses’ job satisfaction, and between the nurses' job satisfaction and the nurses' anxiety levels.

DISCUSSION

Our results show that there is a correlation between the hospital nurse’s job satisfaction and the increased level of anxiety during economic crisis in Lebanon, this result matches what already found in similar study performed in 2016 and showed that a significant proportion of nurses suffered from stress, as well as their satisfaction with job is very low with severe anxiety [9].

Our results also show that there is a cause-effect relation between the salary range and the job dissatisfaction and the level of anxiety

, similar result confirmed by a study in Saudi Arabia, that assessed how dissatisfaction with salary, workload and teamwork, individually and in combination, was associated with those conditions, concluded that the dissatisfaction with workload were significantly associated with both anxiety and stress [10]. Furthermore, our results confirmed that scores for job satisfaction are higher, with lower scores for anxiety, among nurses practicing in private university hospitals compared to those practicing in public university hospitals. This comparison was not found in the literature in our available knowledge. These results are comparable to a cross-sectional study in China in 2019 that focused on the associations between the sub dimensions of occupational stress and psychosomatic wellbeing among nurses, and identified that workload and time pressure were correlated with anxiety. The study also identified that professional and career issues were associated with depression, and that interpersonal relationships and management problems were associated with anxiety, depression, and somatic symptoms [11]. Finally, the results confirm that scores for job dissatisfaction and anxiety are higher among nurses with low salaries compared to their colleagues with high ones, which goes along with what already have been showed in a study conducted in Lebanon and investigated the reasons for the migration of Lebanese nurses and incentives that would attract them back to their home country and showed that the top reasons for nurses to leave Lebanon included unsatisfactory salary or benefits [12].

CONCLUSION

In conclusion the results show the correlation between the decreased nurses job satisfaction with the increased level of anxiety among the hospital nurses in Beirut and South of Lebanon hospitals.

The results of our study also show the high negative correlation between salaries after economic crisis in parallel with the average spending per month and the total job satisfaction in addition to a high positive correlation between the total job satisfaction and the anxiety levels. In addition to the mentioned above, the results showed that both anxiety level and job satisfaction among hospital nurses are subjective to the hospital locations and categories, and to the variables in the sociodemographic and professional characteristics. It also shows how the economic crisis has a significant impact on the nursing physiological status in both job satisfaction and anxiety levels.

Limitations

The study limitation was to have the approval of the of the hospitals in Beirut and South of Lebanon do fill the questionnaire by their staff. We had to shift to other hospitals of the same categories and restart the approval process which compromised our study time.

Local Ethics Committee approval: Approval from three Institutional Review Boards with letters references: “2023-1105” on December 12, 2023, “3/2024” on February 5, 2024, and “IRB23RP26” on December 12, 2023 were obtained for the study.

Conflict of interest and source of funding statement

The authors report no conflict of interest, and the research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors.

Authors’ contribution

All authors contributed to the final manuscript.

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Factors associated with utilisation of staff clinic services by nurses at Parirenyatwa Group of Hospitals, Zimbabwe. A cross-sectional study

Rumbidzai Marevesa ¹ , Maxwell Mhlanga²

Department of Nursing, University of Zimbabwe
Centre of Gender Equity, University of Global Health Equity, Zimbabwe

* Corresponding author: Maxwell Mhlanga, Centre of Gender Equity, University of Global Health

Equity. Zimbabwe. E-mail: mmhlanga@ughe.org

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ABSTRACT

Introduction: Nurses, as gatekeepers of health, are expected to seek formal healthcare services, reflecting the advice they give patients. However, squalid working conditions, long hours, and heavy workloads expose them to occupational health hazards, limiting their ability to care for themselves. Properly implemented employee clinic services can help nurses address health problems, promote well-being, and reintegrate them into the workforce.

Objective: This study sought to determine factors associated with the utilization of staff clinic services by nurses at Parirenyatwa Group of Hospitals.

Materials and Methods: The study used an analytical cross-sectional design conducted in May 2023. A consecutive sampling method selected 50 participants. Data were collected via a structured questionnaire and presented as numbers and percentages. The questionnaire was divided into sections as follows: Participant demographic information (Age, gender, marital status, religion etc.); uptake of staff clinic services (Screening, treatment, awareness services etc), and factors associated with uptake of staff clinic services among nurses. Chi-square test or Fisher’s exact test to evaluate significant differences for unpaired data. Statistical analysis was performed using STATA 16.

Results: Among the 50 participants, 66% were female. The study results show that the uptake of staff clinic services was low, with only 54% of the participants visiting the clinic on rare occasions. The most common barriers to utilizing the staff clinic were lack of time to go for screening (16%), fear of stigma (14%), and uncertainty about confidentiality (14%). Most participants utilized the acute illness treatment service (62%). Age was a significant factor associated with the utilization of the staff clinic (p = 0.021), with younger nurses using the clinic more often. Perceived benefits were also significantly associated with utilization (p < 0.05).

Discussion: The utilization of staff clinic services by nurses remains suboptimal despite high knowledge and awareness of these services. Utilization was mainly associated with age, perceived benefits of accessing the staff clinic services, and reasons for not utilizing some of the services. There is need to strengthen promotional activities for the utilization of staff clinic health services as this has been proven to increase productivity and health outcomes of clinical staff.

Keywords: Utilisation, Staff-clinic, Services, Attitudes.

INTRODUCTION

Healthcare workers are the backbone of any healthcare system, and their well-being is crucial for the delivery of quality healthcare services. Nurses, who constitute a significant portion of the healthcare workforce, are particularly vital as they provide essential patient care and support. In Zimbabwe, the Parirenyatwa Group of Hospitals is the largest medical facility, serving as a critical hub for healthcare delivery in the region. Recognizing the importance of maintaining the health and well-being of its staff, the Ministry of Health and Child Care of Zimbabwe introduced staff clinic services at hospitals, including Parirenyatwa.

Staff clinic services are designed to offer preventive, diagnostic, therapeutic, rehabilitative, and palliative care to healthcare workers, ensuring that they remain healthy and capable of performing their demanding roles. These services are intended to mitigate the health risks associated with the demanding nature of nursing, which includes long hours, heavy workloads, and exposure to various occupational hazards. Despite the availability of these services, there appears to be a significant underutilization among nurses at Parirenyatwa Hospital.

Previous research has highlighted several barriers to the utilization of healthcare services by healthcare workers. Studies have identified factors such as time constraints, concerns about confidentiality, fear of stigmatization, and a perceived lack of need as significant impediments. For instance, a study conducted in Nigeria by Akinyemi revealed that healthcare workers often avoid using available health services due to fears about confidentiality and stigma [1]. Similarly, data from other sub-Saharan African countries, such as Botswana, indicate that age and tenure can influence health service utilization, with younger and less experienced healthcare workers more likely to seek medical assistance [2]. Understanding the specific factors influencing the utilization of staff clinic services at Parirenyatwa Hospital is critical for developing targeted interventions that can enhance service uptake. The unique context of Zimbabwe, characterized by a high burden of infectious diseases such as HIV/AIDS and tuberculosis, further underscores the need for effective health support systems for healthcare workers. The high incidence of these diseases among healthcare workers, combined with the occupational stress they experience, necessitates robust health services that are both accessible and trusted by the staff [3].

Healthcare professionals are susceptible to high levels of occupational stress, which has been defined as the negative physiological and psychological reactions that take place when the job demands do not correspond to their skills, resources, or needs [3]. Long hours, heavy workloads, as well as physical and mental stress of caring for sick patients are some contributing factors. In Zimbabwe, the general working class spends at least a third of their life at work, making them vulnerable to work-related stress. Nurses are additionally exposed to resistant forms of numerous bacteria that are known to live in hospital surroundings, increasing their vulnerability to serious infections that are challenging to treat [4].

The Ministry of Health and Childcare of Zimbabwe introduced staff clinic services at hospitals. The Staff Clinic serves staff members who require healthcare services. These services help healthcare workers cope with the workplace environment and develop healthier behaviours. Clinic services encompass preventive, diagnostic, therapeutic, rehabilitative, or palliative services provided by a facility that is not part of a hospital but is organized and operated to deliver medical care [5].

A wide range of services is provided by clinics. These facilities emphasize the concept of treating the body, offering everything from preventative care to the treatment and management of health conditions. Clinic services can aid in overcoming difficulties to improve the general quality of life as well as significant medical challenges brought on by illness or diseases [6].

This study aimed to identify and analyse the factors associated with the utilization of staff clinic services among nurses at Parirenyatwa Hospital. By examining demographic variables, perceived benefits, and barriers to access, this research sought to provide insights that can inform policy and practice, ultimately leading to improved health outcomes for nurses. Enhanced utilization of staff clinic services not only benefits the nurses themselves but also contributes to the overall efficiency and effectiveness of the healthcare system, ensuring that nurses are healthy and capable of providing high-quality care to their patients.

Objective: The objective of the current study was to determine the factors associated with utilisation of staff clinic services by nurses at Parirenyatwa Group of Hospitals.

MATERIALS AND METHODS

We utilized an analytical cross-sectional study design. This study was conducted at Parirenyatwa Group of Hospitals, which is the largest medical facility in Zimbabwe, located in Harare. In addition to its basic medical and surgical departments, the hospital has a maternity unit, Sekuru Kaguvi, which specializes in eye care, an Annex for patients with mental health issues, and many specialized paediatric wards. In the main hospital complex, there are 12 theatres and more than 5000 beds.

Our study population consisted of nurses at Parirenyatwa Group of Hospitals. We consecutively sampled 50 nurses from across the departments at Parirenyatwa who were on duty, consented to participate in the study, and had been working at Parirenyatwa Hospital for at least six months, as they were more familiar with the clinic services. Nurses on duty were included in the study.

Instruments

A self-designed structured questionnaire was used for data collection, and it was informed by the Health Belief Model. The questionnaire was divided into sections A and B and C as follows:

Section A: Participant demographic information (Age, gender, marital status, religion etc.)

Section B: Uptake of staff clinic services (Screening, treatment, awareness services etc)

Section C: Factors associated with uptake of staff clinic services among nurses. The variables in the study included socio-demographic factors, benefits of clinic services, knowledge, attitude and perceptions, health seeking behaviour, uptake of clinic services. The dependent variable was uptake or utilisation of staff clinic services. The instrument was reviewed for content and face validity by a group of professionals including nurses, lecturers and the Joint Research, and the Ethics Council. The instrument was pre-tested with 5 nurses from Harare hospital and revised to incorporate feedback, to ensure validity, and to address any ambiguity.

Statistical analysis

Data were presented as numbers and percentages in tables. The chi-square test or Fisher’s exact test were performed to evaluate significant differences in proportions or percentages between the two groups. Fisher’s exact test was used where the chi-square test was not appropriate. Finally, all p-values were always two-sided and all tests with p-value (p) < 0.05 were considered significant. Statistical analysis was performed using the STATA ver. 16.

Ethical considerations

The study obtained approval from the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals (JREC) institutional IRB committee (approval number: JREC/23/2023). Written informed consent was obtained from participants, all had the opportunity to review the consent form, ask questions, and discuss the study before signing. Participation was voluntary, and confidentiality was maintained. The rights and welfare of participants were protected, and all research activities were conducted privately. For the current study, in addition to the strict ethical processes employed in the ongoing study, specific additional considerations were implemented.

De-identification of data

A great deal of protection for patient confidentiality was maintained during the conduct of this research, and it will continue to be upheld in the future. Codes only known to the researchers were used with each participant having a unique identifier. These new identities were used throughout the analysis and reporting stages of the study.

Safekeeping of data

Extracted data was saved in a Microsoft OneDrive where it's locked and only accessed by those who have passed through all the orientation and clearance processes and granted access to the data.

RESULTS

The main objective of this study was to determine factors associated with utilization of staff clinic services by nurses at Parirenyatwa Group of Hospitals. Data was collected from 50 study participants who matched the inclusion criteria and major results were presented in tabular form.

Socio-demographic data

A total of 50 nurses were invited to participate in the study. Among the participants, 17 (34%) were male, while 33 (66%) were female. The majority of participants were below the age of 30 years and were married. Similarly, 33 (66%) of the participants resided outside of Parirenyatwa. A significant proportion (50%) of the participants had 1-5 years of working experience, and 96% identified as Christians.

A summary of demographic characteristics is provided in Table 1.

Variable	Description	Frequency (n)	Percentage (%)
Age (years)	< 30	10	40
	30-39	10	20
	40-49	16	32
	> 50	4	8
Gender	Male	17	34
	Female	33	66
Marital status	Married	25	50
	Single	14	28
	Widowed	7	`14
	Separated	4	8
Place of residence	Parirenyatwa	17	34
	Out of Parirenyatwa	33	66
Period of working at Parirenyatwa	6 month – 1 year	7	14
	1 -5 years	25	50
	6 -10 years	14	28
	>10 years	4	8
Religion	Christian	48	96
	Moslem	0	0
	African	2	4
Work station	Parirenyatwa hospital	30	60
	Mbuya Nehanda	8	16
	Sekuru Kaguvi	8	16
	Annex	4	8

Table 1. Distribution of participants by demographic characteristics (n=50)

Uptake of clinic services

All participants were aware of the clinic services offered at the Parirenyatwa staff clinic. Among them, 38 respondents utilized the staff clinic services, while the remaining had never availed themselves of any of the services. A majority of participants had visited the staff clinic infrequently, comprising 54% of the total respondents, whereas 22% had never visited the clinic at all. Among the services provided at the staff clinic, acute illness treatment services were the most utilized. Interestingly, 84% of the participants admitted to self-medicating, and among those who preferred self-medication over utilizing the staff clinic, the percentage was 54%.

Variable	Description	Frequency (n)	Percentage (%)
Clinic services awareness	Yes	50	100
	No	0	0
Staff clinic services utilisation	Yes	38	76
	No	12	24
Staff clinic visit	Often	3	6
	Periodically	9	18
	Rarely	27	54
	Never	11	22
Service satisfaction	Yes	24	48
	No	14	28
	Not applicable	12	24
Screening and testing services	Yes	28	56
	No	3	6
	Not applicable	19	38
Satisfied with results	Yes	27	54
	No	4	8
	Not applicable	19	38
Self-medicated	Yes	42	84
	No	8	16
Self-medication preference	Yes	27	54
	No	23	46
Services accessed at Parirenyatwa	Primary diagnosis	8	16
	HIV testing	5	10
	Mental Health & Psycho-social support	1	2
	Family planning	1	2
	General Medical check up	1	2
	Occupational health	2	4
	Acute illness treatment	31	62
	Not applicable	12	24

Table 2. Presentation of results of uptake of clinic services (n=50)

Factors associated with utilization of staff clinic services.

In the overall evaluation of the clinic services provided, only one participant considered the services to be of high quality, whereas 32 participants (64%) rated the services as good. The primary reason cited for not utilizing some of the staff clinic services was not perceiving a need for them. Additionally, 7 participants (14%) expressed concerns about potential stigmatization, and another 7 (14%) were unsure if the screening results would be kept confidential. Interestingly, 20 participants (40%) acknowledged that accessing the staff clinic helped mitigate work-related health risks.

Variable	Description	Frequency (n)	Percentage (%)
Staff clinic general assessment	Quality services	1	2
	Standard services	15	30
	Moderate services	34	68
Clinic rating	Poor	18	36
	Good	32	64
	Excellent	0	0
Not utilising services reason	Not yet ready to get involved	8	16
	Fear of stigmatisation	7	14
	Not sure if the results from the screening will be kept confidential.	7	14
	Just do not see the needs.	13	26
	Do not have time to go for screening	8	16
	Still needs to be made aware of the need and the importance of the services.	7	14
Health information confidentiality	Yes	7	14
	No	19	38
	Somehow	24	48
Health information used to patronise you	Yes	17	34
	No	33	66
Benefits of accessing clinic	Yes	9	18
	No	14	28
	Partially	27	54
Benefits associated with taking clinic services	Preventing related health risks	20	40
	Increased productivity if treated against infections	13	26
	Ensures healthy working environment	7	14
	Early detection of chronic illnesses	10	20

Table 3. Presentation of results on utilization of staff clinic services

Fisher’s exact test was performed to assess the significance of the association between socio-demographic characteristics and the uptake of staff clinic services. There was a significant association between age and the utilization of staff clinic services (p = 0.013). However, all other variables, including gender, marital status, place of residence, tenure at the hospital, religion, and work station of the respondent, had no association with utilization of staff clinic services (p > 0.05) (Table 4).

Variable	Description	Utilisation of staff clinic		Total	Fisher’s exact *p – value*
Variable	Description	Yes n (%)	No n (%)	n (%)	Fisher’s exact *p – value*
Age (years)	<30	16 (32)	4 (8)	20 (40)	0.013*
	30 – 39	4 (8)	6 (12)	10 (20)
	40 – 39	14 (28)	2 (14	16 (32)
	<50	4 (8)	0 (0)	4 (8)
Gender	Male	13 (26)	4 (8)	17 (34)	0.875
	Female	25 (50)	8 (16)	33 (66)
Marital status	Married	18 (36)	7 (14)	25 (50)	0.468
	Single	10 (20)	4 (8)	14 (28)
	Widowed	6 (12)	1 (2)	7 (14)
	Separated	4 (8)	0 (0)	4 (8)
Place of residence	Parirenyatwa	12 (24)	5 (10)	17 (34)	0.320
	Out of Parirenyatwa	26 (52)	7 (14)	33 (66)
Time worked at the hospital	6 months – 1 year	3 (6)	4 (8)	7 (14)	0.201
	1 – 5 years	19 (38)	6 (12)	25 (50)
	6 – 10 years	12 (24)	2 (4)	14 (28)
	>10 years	4 (8)	0 (0)	4 (8)
Religion	Christian	37 (74)	11 (22)	48 (6)	0.286
	African traditional	1 (2)	1 (2)	2 (4)
Work station	Parirenyatwa	25 (50)	5 (10)	30 (60)	0.198
	Mbuya Nehanda	6 (12)	2 (4)	8 (16)
	Sekuru Kaguvi	5 (10)	3 (6)	8 (16)
	Annexe	2 (4)	2 (4)	4 (8)

* =significant test

Table 4. Association between sociodemographic variables and utilization of staff clinic services.

The results of Fisher’s exact test revealed significant relationships between certain factors and the utilization of staff clinic services. Benefits associated with accessing the staff clinic services and reasons for not utilizing some services were found to be significant factors influencing utilization (p< 0.05). However, health information privacy factors did not show any association with the utilization of staff clinic services.

Although all other remaining factors were associated with the utilization of staff clinic services, these associations were not statistically significant (p > 0.05). Table 5 provides a detailed profile of these results.

Variable	Description	Utilisation of staff clinic		Total	Fisher’s exact *p – value*
Variable	Description	Yes n (%)	No n (%)	n (%)	Fisher’s exact *p – value*
General assessment towards clinic services provided by staff clinic	Quality services	0(0)	4 (8)	1(2)	0.019*
	Standard services	15(30)	6 (12)	0(0)
	Moderate	23(46)	2 (14	11(22)
Clinic services ratings	Poor	11(22)	7(14)	18(36)	0.043*
	Good	27(54)	5(10)	32(64)
Reason for not utilizing some of the services provided	Not yet ready	6 (12)	2 (4)	8 (16)	0.001*
	Fear of stigmatization	7 (14)	0 (0)	7 (14)
	Uncertainty about results confidentiality	7 (14)	0 (0)	7 (14)
	Do not see the need	5 (10)	8 (16)	13 (26)
	Do not have time to go for screening	8 (16)	0 (0)	8 (16)
	Still need get awareness	5 (10)	2 (4)	7 (14)
Do you think your health information is kept confidential at the staff clinic?	Yes	6 (12)	1(2)	7 (14)	0.201
	No	13 (26)	6 (12)	19 (38)
	Somehow	12 (24)	6 (12)	18 (36)
	>10 years	19 (38)	5 (10)	24 (48)
Do you think your health information can be used to patronise you?	Yes	13 (26)	6 (12)	19 (38)	0.186
	No	25 (50)	8 (16)	33 (66)
	Somehow	19 (38)	6 (12)	19 (38)
Has accessing the staff clinic services been beneficial to you?	Yes	8 (16)	1 (2)	9 (18)	0.002*
	No	3 (6)	2 (4)	8 (16)
What benefits do you think are associated with taking these services	Preventing work related health risks	16 (32)	4 (8)	20 (40)	0.165
	Increase productivity if treated against infections	12 (24)	2 (4)	4 (8)
	Working environment	4 (8)	3 (6)	7 (14)
	Early detection of chronic diseases	6 (12)	4 (8)	10 (20)

* =significant test

Table 5. Association between factors associated with utilization (attitudes, perceptions, benefits) and utilization of staff clinic services.

DISCUSSION

The primary aim of this study was to identify the factors influencing the utilization of staff clinic services by nurses at Parirenyatwa Group of Hospitals. Limited research exists on the determinants of nurses' utilization of staff clinic services. Previous studies related to this topic have consistently indicated an underutilization of clinic services by nurses, despite the availability and benefits of such services. Nurses play a crucial role in the healthcare workforce, and maintaining good health is essential for them to deliver high-quality care. Accessing clinic services promotes wellness and helps employees manage their health concerns. Recognizing the gap in nurses' utilization of the staff clinic, the researcher conducted this study to explore the factors influencing their use of these services.

Sociodemographic Factors

Demographic variables such as age, gender, marital status, place of residence, tenure at the hospital, religion, and workstation may influence the utilization of staff clinic services. Powell emphasizes the importance of organizations understanding how these demographic characteristics affect employees' decisions regarding clinic service uptake and their perceptions of these services [9]. Such insights can enhance service uptake and promote inclusivity among employees from diverse backgrounds.

The study revealed a predominantly female participant group, which aligns with the gender distribution in many organizations, particularly in female-dominated professions like nursing. The higher utilization of staff clinic services by females may reflect their majority representation in the workforce. Additionally, younger nurses (below 30 years) exhibited a significantly higher percentage of clinic service utilization (p= 0.013), possibly due to their novelty in the system and enthusiasm for utilizing available services. Conversely, utilization was lower among nurses aged 30-39 and those over 50. This finding contrasts with a study in Botswana by Ledikwe et al., where older age was associated with greater participation in workplace wellness activities [11]. Longer tenure has been associated with higher health service utilization, as seen ina study conducted in South Africa, where more experienced healthcare workers were more familiar with available services and their benefits [15]. Nurses stationed at Parirenyatwa Hospital utilized the staff clinic more frequently than those at Annex Hospital, likely due to the clinic's proximity to their workstations.

The gender distribution indicates that 66% of the participants are female, and 34% are male. This gender disparity is consistent with the global nursing workforce, which is predominantly female. The higher percentage of female participants aligns with studies from other countries, such as Nigeria and Kenya, where female healthcare workers also constituted the majority and showed similar utilization patterns of health services [16].

Marital status revealed that 50% of the participants were married, 28% single, 14% widowed, and 8% separated. The utilization patterns based on marital status were not explicitly explored in this study but could provide an interesting angle for future research. Previous studies have shown mixed results, with some indicating higher health service utilization among married healthcare workers due to family health considerations.

The study found that 34% of participants resided at Parirenyatwa, while 66% lived outside. This aligns with findings from studies in urban areas where proximity to healthcare facilities influences utilization rates. Healthcare workers living closer to their workplace are more likely to use available services due to convenience.

An overwhelming majority of participants were Christian (96%), with a small minority adhering to African traditional religions (4%). Religious beliefs can impact health service utilization, although this study did not find a significant variation in utilization patterns based on religion. Similar studies have found that religion can sometimes influence health-seeking behavior due to different cultural beliefs about healthcare.

The distribution of work stations showed that 60% of participants were stationed at Parirenyatwa Hospital, with the remainder distributed among Mbuya Nehanda, Sekuru Kaguvi, and the Annex. Utilization of staff clinic services may vary by work station due to differences in work environments and stress levels. For instance, nurses working in high-stress areas such as emergency departments or mental health units may have different health service needs compared to those in less stressful environments.

The study reveals important socio-demographic factors associated with the utilization of staff clinic services at Parirenyatwa Hospital. While gender and age distributions are consistent with global trends, factors such as place of residence and work station highlight the importance of proximity and work environment in health service utilization. These findings are consistent with similar studies in the region, emphasizing the need for targeted interventions to address barriers and promote the utilization of health services among healthcare workers.

Quality of Services and Clinic Ratings

Only 2% of nurses rated the clinic services as quality, while 30% and 68% rated them as standard and moderate, respectively. Furthermore, 36% rated the clinic as poor, 64% as good, and none rated it as excellent. Similar studies, have often report mixed perceptions of healthcare service quality in resource-limited settings [12]. Inconsistent service quality is a common issue that can deter utilization of health services [13].

Key reasons for not using the clinic services include lack of readiness (16%), fear of stigmatization (14%), concerns about confidentiality (14%), perceiving no need (26%), lack of time (16%), and needing more awareness (14%). Similar barriers are found in other studies. For instance, the fear of stigmatization and confidentiality concerns are widely reported in healthcare settings across Sub-Saharan Africa [7]. Time constraints and perceived lack of need are also common barriers identified in healthcare utilization studies [14].

Only 14% believed their health information was kept confidential, 38% said no, and 48% were unsure. Concerns about confidentiality are prevalent in many studies, where mistrust in the healthcare system hinders service utilization. Efforts to enhance confidentiality practices are essential to improve service uptake [15].

About 34% reported that health information was used to patronize them, while 66% did not. Such experiences can significantly deter individuals from seeking healthcare, as highlighted in research another research, which reported that negative experiences with healthcare providers reduce trust and subsequent utilization [15].

Only 18% perceived clear benefits from accessing clinic services, 28% did not, and 54% partially saw benefits. Benefits cited included preventing health risks (40%), increased productivity (26%), ensuring a healthy environment (14%), and early detection of chronic illnesses (20%). The recognition of health benefits, such as early detection and productivity gains, is crucial for increasing service uptake. There is need to emphasize the importance of communicating these benefits effectively to encourage utilization.

Awareness and Utilization

Although all participants were aware of the staff clinic services, utilization rates varied, with acute illness treatment being the most frequently used service. However, services such as primary diagnosis, HIV testing, mental health support, family planning, and general medical check-ups were underutilized. Reasons for not utilizing some services included time constraints, concerns about result confidentiality, and fear of stigmatization. These findings are consistent with a study in Nigeria by Akinyemi on healthcare workers' health-seeking behavior. The study also found a significant association between the perceived benefits of staff clinic services and their utilization. Participants who found the services beneficial were more likely to utilize them, highlighting the influence of attitudes and perceptions on service uptake.

A significant finding of the study is the association between perceived benefits and utilization of staff clinic services. Participants who found the services beneficial were more likely to utilize them (p = 0.002). This highlights the importance of perceived benefits in influencing health service uptake. Similar trends have been observed in other studies, where positive perceptions of health services were linked to higher utilization rates [18]. The significant association between perceived benefits and service utilization emphasizes the need for targeted interventions to address barriers and promote the use of health services among healthcare workers.

Quality of Service

Participants' assessments of the clinic services showed significant differences. Quality services were rated by only 2% of the participants, standard services by 30%, and moderate services by 46% (p = 0.019). This indicates a general perception that the services are not of high quality. Similar studies in Nigeria and Kenya also reported that healthcare workers rated their staff clinic services as moderate to poor, citing inadequate resources and staffing as primary reasons for these perceptions [15].

When rating the clinic services, 22% of participants rated them as poor, 14% as good, and 64% as excellent (p = 0.043). This distribution suggests a polarized view, where a significant portion of users is dissatisfied with the services, while others find them adequate. A comparable study in South Africa found that ratings of clinic services were closely tied to the perceived responsiveness and professionalism of the staff, as well as the availability of medical supplies [18]. The mixed ratings at Parirenyatwa Hospital align with these findings, highlighting the importance of improving service quality to enhance user satisfaction.

The reasons for not utilizing some of the services provided were also significantly varied. The most common reasons included not seeing the need for the services (26%), not having time to go for screening (16%), and fear of stigmatization (14%) (p = 0.001). These barriers are consistent with findings from a study in Botswana, which reported that healthcare workers often avoided utilizing available health services due to similar reasons, including time constraints and fears about confidentiality [8].

Fear of stigmatization and concerns about the confidentiality of results were significant deterrents, with 14% of participants citing each as reasons for not using the clinic services. This is in line with studies conducted in Nigeria and Malawi, where healthcare workers expressed concerns about privacy and potential negative repercussions on their professional reputation if their health conditions were disclosed.

A notable 14% of participants indicated that they still needed to be made aware of the importance of the services. This points to a gap in effective communication and education about the benefits of utilizing the staff clinic. A similar issue was highlighted in a study in Uganda, where increased awareness and educational campaigns were found to significantly improve the utilization rates of staff clinic services [19].

The study at Parirenyatwa Hospital reveals several factors influencing the utilization of staff clinic services that are consistent with findings from similar studies in other regions. Key issues such as service quality, fear of stigmatization, confidentiality concerns, and the need for increased awareness are recurrent themes. Addressing these barriers through targeted interventions could significantly improve the uptake of staff clinic services, leading to better health outcomes for nurses. Enhancing service quality, ensuring confidentiality, and conducting awareness campaigns are essential steps to encourage higher utilization rates and improve overall healthcare delivery among healthcare workers.

Limitations of the study

The sample size for our study was relatively smaller than what would be required for the generalisation of the study findings. Similarly, we used self-reported satisfaction of the participants which increases the chances for social desirability bias. Future studies can consider using the mixed methods approach with a bigger sample to triangulate data and get a clearer picture on the subject matter.

CONCLUSION

In conclusion, nurses' utilization of clinic services is influenced by their attitudes, perceptions, and barriers to access. Despite high awareness, service utilization remains low for certain offerings. Efforts to increase utilization should address barriers such as concerns about confidentiality and stigma, while also emphasizing the perceived benefits of the services. Enhancing the quality of services and fostering positive employee attitudes can further promote utilization and improve overall healthcare outcomes among nurses.

Funding statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not for profit sectors.

Conflict of interest

The authors report no conflict of interest.

Authors’ contribution

Rumbidzai Marevesa: Development of the original draft

Maxwell Mhlanga: Review of the manuscript, data analysis and discussion.

Acknowledgements

We would want to acknowledge Management at Parirenyatwa Group of Hospitals for allowing us to carry out our research at their institution.

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