Abstract
This pilot study was conducted to evaluate the practicality, patient acceptance, and initial impact of a psychoeducational program designed for hemodialysis (HD) patients and their families. The study involved a single group of six patient-family dyads over six weeks, utilizing a multifamily group format. The program’s feasibility was assessed through screening, eligibility, content relevance, retention, completion, and adherence rates. Acceptability was gauged via a post-intervention focus group interview. Patient-reported anxiety and depression levels, along with inter-dialytic weight gain (IDWG), were also measured. The study demonstrated satisfactory screening (93.5%), retention (85.7%), and completion (100%) rates. However, eligibility (22.8%), consent (18.4%), and intervention adherence (16.7–50%) rates indicated areas for improvement. Participants expressed positive feedback, highlighting the educational and emotional benefits of the intervention. Statistical analysis using the Wilcoxon Signed-Rank Test revealed a significant reduction in anxiety symptoms (p = 0.025, r = 0.646). Medium to large within-group effect sizes were observed for changes in depression symptoms (p = 0.261, r = 0.325) and patients’ IDWG (p = 0.248, r = 0.472). Overall, the findings suggest that this family-centered psychoeducational intervention holds promise for HD patients and their family caregivers. However, refinements are necessary to enhance its practicality and ease of implementation within routine dialysis care before broader trials are undertaken.
Keywords: chronic kidney disease, dialysis, family-based intervention, psychoeducation, feasibility study
1. Introduction
End-stage renal disease (ESRD), a critical condition characterized by irreversible kidney failure, necessitates renal replacement therapy (RRT) for patient survival [1]. The global prevalence of ESRD is on the rise, particularly among individuals aged 65 and older, largely driven by age-related chronic conditions such as diabetes and cardiovascular disease [2,3].
Hemodialysis (HD) stands as the most prevalent RRT method, typically administered 3–4 times weekly in dialysis centers, with each session lasting 4–5 hours [4]. Beyond dialysis sessions, patients must adhere to a stringent regimen encompassing fluid restriction, dietary adjustments, medication schedules, vascular access maintenance, and regular exercise [5,6].
Furthermore, individuals undergoing HD often grapple with significant psychosocial challenges stemming from ESRD and its treatment, including emotional distress and diminished quality of life [7,8]. Notably, the incidence of psychiatric disorders, such as depression, is substantially higher in ESRD patients compared to those with other chronic illnesses like cancer or congestive heart failure [9]. Depression in ESRD is also linked to poorer treatment adherence [10], which in turn can lead to adverse clinical outcomes and reduced survival rates [11,12].
Family support plays a vital role in patient adherence to ESRD treatment regimens [13] and is associated with improved survival and quality of life [14,15,16,17]. However, providing care for HD patients can be demanding, often leading to social isolation, sleep disturbances, and emotional distress for family members [18,19,20]. Despite the profound impact on both patients and their families, conventional renal rehabilitation programs primarily focus on patient education, covering aspects like nutrition, lifestyle modifications, disease pathology, treatment, and self-management [21,22]. Psychosocial support is often limited, and the broader impact of ESRD on family life is frequently overlooked.
Recognizing these shortcomings, there has been a growing emphasis on family-based psychoeducational interventions for various chronic conditions, including cancer [23], stroke [24], and respiratory diseases [25,26]. These interventions aim to equip families with health education and psychosocial support to enhance coping and adaptation through practical guidance for crisis management, problem-solving, and stress reduction [27]. This family-centered approach prioritizes the educational, relational, and emotional needs of the entire family unit. Meta-analyses have indicated that family-oriented psychosocial interventions yield better physical and mental health outcomes for both patients and family members compared to patient-focused interventions or standard medical care [28,29,30,31].
Despite the increasing recognition of the benefits of family-based interventions in chronic disease management, and specific recommendations for their development in ESRD [22], current interventions for ESRD/HD management remain largely patient-centric. To date, there is limited evidence supporting this approach. Therefore, this pilot study primarily aimed to assess the feasibility and acceptability of a family-based psychoeducational intervention for ESRD patients undergoing HD and their family members. Secondarily, it sought to explore the intervention’s preliminary effects on psychological distress and patients’ weight and fluid management. Given the novelty of this research and uncertainties regarding the intervention’s operational feasibility and acceptance among ESRD patients and families, a pilot study is crucial for informing the design and justification of future randomized controlled trials [32,33,34].
2. Methods
2.1. Design and Setting
This study employed a single-group, pre-post pilot design over six weeks, involving six dyads, totaling 12 participants (six patients and six family members). Recruitment was conducted at a dialysis center in Portugal between September and October 2019. The multifamily group intervention sessions were held from October 26 to November 30, 2019.
2.2. Participants
Patient inclusion criteria comprised: adult age (≥18 years), ESRD diagnosis, and undergoing HD for at least three months. Exclusion criteria included: return to dialysis post-kidney transplant failure, comorbidities such as cancer or infectious diseases, and severe mobility or sensory impairments hindering study participation. Family members were required to be adults and identified as the patient’s primary support provider. Exclusion criteria for both patients and family members were: current psychotherapeutic intervention, neuropsychiatric conditions, and inability to understand or engage in the study. All participants were required to understand the study’s purpose and provide voluntary consent.
2.3. Recruitment
Researchers screened patients for eligibility based on the defined criteria. Eligible patients were then approached, the intervention explained, and their willingness to participate was solicited. Verbal consent was obtained, followed by permission to contact their primary caregiver to assess their eligibility and willingness. Written consent was obtained from both patient and family member one week before the intervention commenced. Reasons for declining participation were documented.
2.4. Intervention
The intervention’s design was informed by a comprehensive review of ESRD literature [5,35,36,37,38], evidence on family-based interventions in chronic conditions [25,26], researchers’ clinical experience, and insights from interviews with HD patients and family caregivers. Recognizing the limited systematic data on the educational and support needs of individuals and families affected by ESRD, the study prioritized understanding patient and caregiver perspectives to ensure the intervention’s relevance, adequacy, and effectiveness [39,40]. Pre-pilot study interviews with patients, family members, and dyads revealed a shared expectation that a family-based intervention would improve access to information about ESRD and HD management (e.g., fistula care, nutrition, physical activity, social and financial support), enhance emotional support, improve coping skills and communication with healthcare providers, and strengthen family involvement in disease management [41,42,43,44]. Existing research suggests that family psychoeducation typically includes information on treatments, symptom management, community resources, skills training for disease-related problems, and strategies for problem-solving and emotional management during stressful periods in chronic disease progression [27].
Consequently, the intervention consisted of six weekly 120-minute sessions delivered in a multifamily group format to reduce family isolation and foster mutual support and idea exchange among families facing similar challenges [27]. Each session had educational and supportive components. Education aimed to provide ESRD and HD information, enhance disease management skills, and promote strategies for diet, fluid intake, exercise, weight control, and vascular access care. Psychosocial support focused on managing emotional challenges of living with ESRD and HD, developing communication skills for interacting with healthcare professionals, and fostering family identity and cohesion.
Sessions were facilitated by a multidisciplinary team (psychologist, nurse, physician) coordinated by two clinical psychologists experienced in psychoeducational interventions for chronic diseases. Facilitators supported participants, encouraged experience sharing, normalized emotions, and used empathetic communication. Active learning methods included group discussions, role-playing, brainstorming, and educational quizzes. Sessions were held at the dialysis center. Session content is detailed in Table 1.
Table 1. Content of the intervention program.
| Session | Component | Intervention/Aims |
|---|---|---|
| 1 | Supportive | The psychosocial impacts of ESRD and HD on family life: to explore the current beliefs and representations about the disease and treatment and ascertain its negative and positive impacts on family life. |
| 2 | Educative | The benefits of physical activity and exercise for patients with ESRD and their family members: to explore the barriers and motivators for exercise and how to integrate physical activity into daily routines. |
| 2 | Supportive | Emotional regulation: to improve and explore emotion-management strategies by clarifying the interface between emotions, thoughts, and behaviors with examples from experiences with ESRD and HD demands. A guided imagery relaxation technique was also used. |
| 3 | Educative | Care with vascular access: to inform about the importance of caring for the vascular access and improve knowledge on the different precautions to be taken with the arteriovenous fistula (before, during, and after each dialysis session). Obs.: The educational component of this session was supported by a nurse with extensive clinical experience in vascular access management in patients undergoing HD. |
| 3 | Supportive | Interpersonal communication: to provide dyads with communication skills to facilitate interaction with other patients, healthcare professionals, and family members. |
| 4 | Educative | Social and community resources: to increase the involvement of families with the community in order to avoid social isolation (by delivering information about patients’ and caregivers’ associations, social events in the community, traveling while on HD, and clarifying patients’ and caregivers’ social rights). |
| 4 | Supportive | Problem solving: to increase skills to deal with problematic situations associated with ESRD, HD, its side effects, and consequences in daily life (e.g., strategies to increase adherence to poly-medication protocols, to improve memorization, to manage fluids and dietary restrictions in social situations). |
| 5 | Educative | Fluids and dietary restrictions in ESRD: to improve dyads’ knowledge about fluids and dietary requirements and how to manage them. |
| 5 | Supportive | Family identity beyond ESRD: to explore the impacts of chronic disease on family identity; to increase family cohesion through the development of a common identity decentralized from the limitations that ESRD imposes. |
| 6 | Supportive | Meaning in life: to encourage the family to identify the different sources of meaning from past and present experiences, reframe the experience with the disease, and establish future life goals. Ritualization and finalization. |
Table 1 provides a detailed breakdown of the content covered in each session of the family-based psychoeducational intervention program for ESRD and HD.
ESRD = end-stage renal disease; HD = hemodialysis.
2.5. Primary Outcome Measures
2.5.1. Feasibility
Intervention feasibility was assessed through screening rate, eligibility rate and reasons for exclusion, consent rate and reasons for non-participation, retention rate, completion rate, adherence rate, and intervention acceptability.
2.5.2. Screening Rate
Screening rate was defined as the proportion of ESRD patients assessed for study eligibility by researchers based on inclusion/exclusion criteria.
2.5.3. Eligibility Rate and Reasons for Exclusion
Eligibility rate was the proportion of screened patients meeting inclusion criteria, calculated by dividing eligible patients by the total number of HD patients at the recruitment site. Reasons for exclusion were documented.
2.5.4. Consent Rate and Reasons for Not Participating in the Study
Consent rate was calculated as the proportion of eligible patients who verbally consented to participate. Family member consent was contingent on patient consent. Reasons for non-participation were recorded.
2.5.5. Retention Rate
Retention rate was defined as the proportion of participants who remained in the study without formal dropout.
2.5.6. Completion Rate
Completion rate was the proportion of participants completing self-reported measures at baseline and T1 (two weeks post-intervention).
2.5.7. Intervention Adherence
Intervention adherence was measured by the total number of sessions attended by participants. Reasons for session absence were recorded.
2.5.8. Acceptability
Acceptability, defined as the extent to which users find an intervention appropriate and meeting their needs [45], was assessed post-intervention via a focus group interview. This method is recommended for evaluating healthcare intervention acceptability, revealing areas for modification before large-scale trials [45]. To minimize response bias, the interview was conducted eight weeks post-intervention by researchers not involved in intervention delivery. A semi-structured guide explored participant perspectives on intervention impacts, benefits, disadvantages, participation barriers and facilitators, and suggestions for content, structure, and organization. The focus group interview lasted approximately 111 minutes.
2.6. Secondary Outcome Measures
2.6.1. Symptoms of Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) [46,47] was used to assess anxiety and depression symptoms. This 14-item instrument has two 7-item subscales for anxiety and depression symptoms in the past week, using a 4-point Likert scale (0-3). Subscale scores range from 0 to 21. Internal consistency in this sample ranged from 0.714 to 0.849 for anxiety and 0.779 to 0.828 for depression, indicating good reliability. The HADS was administered at baseline and post-intervention.
2.6.2. Interdialytic Weight Gain (IDWG)
IDWG, a common indicator of fluid control in HD patients and a potential marker of nutritional status [48,49], was measured as a monthly average (12 consecutive sessions) before and after intervention, retrieved from medical records. National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines [50] recommend IDWG be less than 4.0–4.5% of dry weight for patients on HD three times weekly.
2.7. Quantitative Data Analysis
Descriptive statistics were calculated for sociodemographic and clinical variables. Pre- and post-intervention within-group differences were analyzed using the Wilcoxon Signed-Rank Test. A p-value < 0.05 was considered statistically significant. Effect sizes were interpreted using Cohen’s r (0.10 = small effect, 0.30 = medium effect, and 0.50 = large effect) [51].
2.8. Qualitative Data Analysis
The focus group interview was audio-recorded, transcribed verbatim, and analyzed by two independent researchers using content analysis, following Braun and Clark’s recommendations [52]. The transcript was reviewed for overall understanding. Expressions and sentences relevant to research questions were highlighted and grouped into similar concepts, forming categories with supporting quotes. Initial themes were compared, reviewed, and consensus was reached. A third author was consulted in case of disagreement. Final decisions were based on theme/subtheme richness. Trustworthiness, confirmability, and reflexivity were enhanced through the involvement of three authors in data analysis, with final subthemes resulting from critical dialogues and discussion. All researchers had experience with chronic disease patients and families but no personal ESRD experience.
2.9. Ethical Considerations
The study received ethical approval from the Fresenius Medical Care-Portugal Ethics Committee (Reference 03/2019) and adhered to the Helsinki Declaration. Written informed consent was obtained from all participants. Confidentiality was maintained by assigning numerical codes to patients.
3. Results
3.1. Participants’ Characteristics
Table 2 presents participant sociodemographic and clinical characteristics. ESRD patients (n = 6) had a mean age of 65.3 years (SD = 13.3), with an even gender distribution. Most were married (n = 5) and retired (n = 5). Patients had been on HD for an average of 50.7 months (SD = 59.2). Family members (n = 6) were all women with a mean age of 47.3 years (SD = 15.6).
Table 2. Participants’ characteristics (n = 12).
| Participants’ Characteristics | Patients (n = 6) | Family Members (n = 6) |
|---|---|---|
| Gender, n (%) | ||
| Male | 3 (50%) | 0 (0%) |
| Female | 3 (50%) | 6 (100%) |
| Marital Status, n (%) | ||
| Single | 0 (0%) | 1 (16.7%) |
| Married | 5 (83.3%) | 5 (83.3%) |
| Widower | 1 (16.7%) | 0 (0%) |
| Employment Situation, n (%) | ||
| Employee | 1 (16.7%) | 3 (50%) |
| Student | 0 (0%) | 1 (16.7%) |
| Housewife | 0 (0%) | 1 (16.7%) |
| Retired | 5 (83.3%) | 1 (16.7%) |
| Family Relationship, n (%) | ||
| Spouse–Partner | 3 (50%) | |
| Parent–Child | 3 (50%) | |
| Mean (± SD) (Min–Max) | Mean (± SD) (Min–Max) | Mean (± SD) (Min–Max) |
| Age (years) | 65.3 (± 13.3) (48–77) | 47.3 (± 15.6) (21–67) |
| Length of time on dialysis (months) | 50.7 (± 59.2) (6–153) |
Table 2 summarizes the demographic and clinical profiles of both patient and family member participants in the study.
SD = Standard Deviation.
3.2. Primary Outcomes
3.2.1. Screening Rate
The screening rate was 93.5%. Out of 167 HD patients at the recruitment site over four months (July-October 2019), 156 were assessed for eligibility.
3.2.2. Eligibility Rate and Reasons for Exclusion
The eligibility rate was 22.8%, with 38 of 167 patients meeting criteria. Exclusion reasons for the remaining 118 patients included: neuropsychiatric disorder (n = 36), limited mobility/sensory impairment (n = 22), anticancer treatment (n = 16), kidney transplant failure (n = 14), inability to read (n = 8), infectious disease (n = 7), no family caregiver (n = 6), receiving psychotherapeutic intervention (n = 5), caregiver receiving psychotherapeutic intervention (n = 3), and HD for less than three months (n = 1).
3.2.3. Consent Rate and Reasons for Not Participating in the Study
The consent rate was 34.2%, with 13 of 38 eligible patients providing verbal consent. The 25 patients who declined cited: lack of transport to the dialysis unit on intervention days (n = 8), unwillingness to engage in more “disease-related activities” (n = 6), family member unavailability (n = 6), and perceived lack of need (n = 5). Family member consent rate was 76.9% (10 of 13 contacted).
One week before intervention, the consent rate was recalculated. Six patients withdrew due to: family member unavailability/disinterest (n = 3), medical reasons (n = 2), and transportation issues (n = 1). The final consent rate was 18.4%.
Ultimately, seven dyads (14 participants) provided written consent and were enrolled.
3.2.4. Retention Rate
The retention rate was 85.7%, with one dyad (two participants) dropping out after the first session due to caregiver work responsibilities.
3.2.5. Completion Rate
The completion rate was 100% for all self-report measures at both assessment points.
3.2.6. Intervention Adherence
Intervention adherence varied: 16.7% completed all six sessions, 50% attended five sessions, and 33.3% attended four sessions. Reasons for missing sessions included family member unavailability due to work/family duties, participation in other activities, and patient clinical condition worsening.
3.2.7. Acceptability
Focus group interview findings indicated positive participant experiences. Content analysis revealed four themes: (i) perceived educational and emotional benefits; (ii) intervention downsides; (iii) participation barriers and facilitators; and (iv) suggestions for intervention content, structure, and organization.
Participants reported improved knowledge of ESRD, HD, diet, vascular access care, and exercise, along with enhanced problem-solving and emotional regulation skills. They also reported reframing ESRD and realizing that negative impacts could be managed. Family member presence was seen as beneficial, and provided pamphlets and infographics were helpful for information retention. The main downside mentioned was insufficient session time to explore themes in depth.
Barriers to participation included difficulty attending sessions, especially on dialysis days due to patient fatigue. Facilitators included psychologist support and bonding among participants, fostering mutual support.
Suggestions for future interventions included more information on social benefits, dietary management, kidney transplantation, and longer session durations. Participants agreed this intervention type would be most beneficial for patients starting dialysis, and they would recommend it to others.
3.3. Secondary Outcomes
Preliminary Effects
The Wilcoxon Signed-Ranked Test (Table 3) showed a significant decrease in anxiety symptoms (p = 0.025, r = 0.646). Depression symptoms also decreased, though not significantly (p = 0.261, r = 0.325), but with a medium effect size. IDWG decreased post-intervention, also non-significantly (p = 0.248, r = 0.472), but with a large effect size.
Table 3. Results from the Wilcoxon Signed-Ranked Test for pre and post-intervention scores (n = 12 participants).
| Pre-Intervention | Post-Intervention | ||||
|---|---|---|---|---|---|
| Q1 | Median | Q3 | Q1 | Median | |
| HADS-Anxiety | 3.00 | 6.50 | 10.8 | 1.25 | 4 |
| HADS-Depression | 2.25 | 6.50 | 9.00 | 1.00 | 6.50 |
| IDWG (patients only, n = 6) | 2.18 | 2.60 | 3.15 | 1.63 | 2.15 |
Table 3 presents the statistical results of the Wilcoxon Signed-Ranked Test, comparing pre- and post-intervention scores for anxiety, depression, and interdialytic weight gain.
HADS = Hospital Anxiety and Depression Scale; IDWG = Interdialytic Weight Gain.
4. Discussion
Family support is a crucial resource for HD patients, aiding in various aspects of treatment adherence and overall well-being [17,18,19]. However, the effectiveness of family-based interventions in ESRD remains under-explored. This pilot study is among the first to investigate the feasibility, acceptability, and preliminary effects of a family-based psychoeducational intervention for HD patients and their families. Findings suggest the intervention is feasible, acceptable, and potentially effective, though some aspects require further consideration before large-scale trials.
The high screening rate (93.5%) suggests good representation of the target population [34]. However, the modest eligibility rate (22.8%) aligns with previous feasibility studies of psychological interventions for HD patients [53]. Cognitive impairment, mobility limitations, and cancer diagnosis were primary exclusion reasons, consistent with the reported prevalence of cognitive impairment in ESRD patients [54]. ESRD is associated with cognitive deficits across various domains [55,56,57], potentially hindering participation in psychoeducational interventions. Future research should focus on interventions tailored for cognitively impaired dialysis patients and their caregivers, who are at higher risk of depression and burden [62].
The suboptimal consent rate (18.4%) compared to cancer intervention studies [63] highlights the importance of understanding non-participation reasons to improve consent in future trials [34]. Transportation issues were the main barrier, as free patient transport to dialysis treatment does not extend to intervention sessions, creating a potential financial burden. Monetary compensation, while ethically complex, could improve accessibility and consent rates [64].
The satisfactory retention rate (85.7%) [65] and excellent completion rate (100%) contrast with the low intervention adherence. Only 16.7% completed all sessions, raising concerns about intervention rejection due to non-adherence [34]. However, qualitative findings from the focus group indicated high acceptability and perceived benefits, including increased knowledge, mutual support, emotional validation, coping skills development, and hope. Time and effort to attend sessions were identified as barriers, consistent with other HD patient support trials [53]. The demanding HD treatment schedule might make additional dialysis center visits burdensome. Online interventions could offer a solution, potentially improving consent and adherence by reducing transportation burdens and allowing home participation. A feasibility study of technology-assisted cognitive-behavioral therapy for HD patients showed promising results with good adherence and satisfaction [66]. Further research is needed to explore the feasibility and acceptability of family-based psychoeducational online interventions in ESRD.
Preliminary effectiveness was indicated by a significant decrease in anxiety symptoms and medium to large effect sizes for depression symptoms and IDWG. Larger sample sizes could increase the likelihood of statistically significant findings [67].
Limitations
This pilot study has limitations including single-center recruitment and no control group, limiting generalizability for large-scale trials. Strict inclusion criteria excluded patients with common comorbidities and transplant failure, further limiting generalizability. The small sample size restricts definitive conclusions about treatment effectiveness. Participant recruitment over two months and subsequent waiting time for intervention start may have contributed to dropouts before intervention commencement.
5. Conclusions
This pilot study provides valuable initial evidence suggesting that family-based psychoeducational interventions are feasible, acceptable, and potentially beneficial for HD patients and their families. Participants positively received the intervention, which appeared to reduce psychological distress. The study also highlighted recruitment and adherence challenges. Strategies to improve eligibility, consent, and adherence are needed to enhance the prospects of successful large-scale trials. Multicenter recruitment and broader outcome measures would strengthen future research. Further research is essential to optimize the attractiveness and practicality of family-based psychoeducational interventions for routine dialysis care implementation.
Acknowledgments
The authors gratefully acknowledge the healthcare professionals who contributed to the educational component of the intervention program.
Author Contributions
Conceptualization, D.F.; methodology, D.F., H.S., O.R. and R.F.; formal analysis, H.S. and D.F.; data curation: D.F.; Supervision: D.F., O.R., C.P. and F.R.; investigation, H.S., R.F., J.O., O.R. and D.F.; resources: E.C. and V.M.; writing—original draft preparation, H.S. and D.F.; writing and supervision, D.F. and O.R.; project administration, D.F. and O.R.; funding acquisition, D.F. All authors have read and agreed to the published version of the manuscript.
Funding
This research was funded by the project POCI-01-0145-FEDER-030228, funded by FEDER, through COMPETE2020 Programa Operacional Competitividade e Internacionalização (POCI), and by national funds (OE), through FCT/MCTES. Additionally, Helena Sousa has a PhD grant scholarship (reference number DFA/BD/4821/2020) financed by FCT (Fundação para a Ciência e Tecnologia) through FSE (Fundo Social Europeu).
Institutional Review Board Statement
The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethical Committee of the Fresenius Medical Care—Portugal (Reference number 03/2019).
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Conflicts of Interest
The authors declare no conflict of interest.
Footnotes
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
