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Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.
We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.
The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.
To investigate the association between emotional responses to climate change, antenatal anxiety, and maternal–fetal attachment in primigravida women.
A multi-site cross-sectional research design study.
This study was conducted at four primary health care (PHC) facilities in Damanhur district, El-Behera, from February 2024 to April 2024. Two hundred eighty-five women completed a comprehensive questionnaire that included a Woman's Social and Reproductive Form, The inventory of climate emotions (ICE) scale, The Stirling Antenatal Anxiety Scale (SAAS) and the Maternal–Fetal Attachment Scale (MFAS-HU-20).
The study revealed that emotional responses to climate change show strong positive correlations with each other, ranging from 0.689 to 0.840, all significant at p < 0.001 level. Additionally, antenatal anxiety demonstrates substantial positive correlations with emotional responses to climate change, albeit with associations ranging from 0.239 to 0.287, all significant at p < 0.001 level. Moreover, maternal–fetal attachment displays substantial negative correlations with emotional responses to climate change, indicating that as emotional responses to climate change increase, maternal–fetal attachment tends to decrease. The correlations range from −0.263 to −0.426, all significant at p < 0.001.
The emotional impact of climate change can adversely affect the bonding process between mother and fetus.
Healthcare professionals, including obstetricians, midwives, and mental health counsellors, should integrate climate-related emotional distress into their assessments and interventions. Providing targeted psychological support for expectant mothers.
The study's findings highlight the need for nursing to integrate climate-related emotional distress screening into prenatal care and for research to explore long-term effects and intervention effectiveness. In practice, healthcare providers should adopt holistic approaches that combine environmental and psychological support, developing comprehensive guidelines and community-based programs to support pregnant women.
The research adhered to that is STROBE.
Public contributions by women in community health centers.
To investigate the relationship between a quality of life (QOL) score and clinical parameters in patients with hypertrophic cardiomyopathy (HCM).
A multicentre cross-sectional study.
We analysed data from the Searching for Atrial Fibrillation and Early Recruitment of Heart Failure in HCM registry, collected between 2018 and 2023.
Patients with HCM (n=499) aged ≥18 years from 12 institutions (Shizuoka Prefecture, Japan) were consecutively enrolled.
Clinical parameters, along with data from a short form of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), were collected. The association between each clinical parameter and the KCCQ-12 score was analysed. Clinical parameters with a significant univariable association (p
In the univariable analysis, KCCQ-12 scores exhibited significant associations with 21 clinical parameters, including sex, left ventricular morphology and the Pittsburgh Sleep Quality Index (PSQI). The multiple regression model with 12 parameters that had a significant univariable association exhibited an adjusted R2 of 0.48. In this model, the PSQI (standardised coefficient –0.39; p
In patients with HCM, we investigated the association between the KCCQ-12 score and various clinical parameters. PSQI, as well as known heart failure-related clinical parameters, was significantly associated with the KCCQ-12 score. Visualising the associations of various clinical parameters with the KCCQ-12 score will help physicians to consider factors linked to the decline in QOL in patients with HCM.
Sleep disturbances and delirium are prevalent problems in the intensive care unit. Evidence suggests that these conditions negatively impact patient outcomes by increasing the length of hospital stays, delaying recovery, and raising healthcare costs.
This study aimed to investigate the effect of implementing a sleep care bundle on sleep quality and delirium among critically ill patients.
A quasi-experimental research design was used. A purposive sample of 66 patients was divided equally into two groups: a bundle group that received a sleep care bundle and a control group that received routine unit care in the chest intensive care units at Mansoura University in Egypt. Data were collected using the critically ill patients' outcome evaluation tool based on the Richards-Campbell Sleep Questionnaire Scale and the Intensive Care Delirium Screening Checklist.
Compared to the control group, the bundle group demonstrated statistically significant improvements across all sleep quality domains measured by the Richards-Campbell Sleep Questionnaire by Day 3. Specifically, sleep depth improved from 1.24 ± 0.44 to 1.82 ± 0.39 (effect size = 0.600), ability to fall asleep from 1.21 ± 0.42 to 1.91 ± 0.29 (effect size = 0.703), number of awakenings from 1.27 ± 0.45 to 1.79 ± 0.42 (effect size = 0.483), sleep efficiency from 1.24 ± 0.44 to 1.76 ± 0.44 (effect size = 0.600), and overall sleep quality from 1.24 ± 0.44 to 1.85 ± 0.36 (effect size = 0.600). In addition, the occurrence of delirium on Day 3 was significantly lower in the bundle group (0.0%) compared with the control group (15.2%) (χ 2 = 7.471, p = 0.023). Subsyndromal delirium was observed in 6.1% of the bundle group and 15.2% of the control group. The overall percentage of patients without delirium was significantly higher in the bundle group (93.9%) compared to the control group (69.7%).
Implementing a sleep care bundle enhances sleep quality and reduces the occurrence of delirium in critically ill patients. Therefore, it can be integrated as an adjunctive intervention alongside routine care for these patients. To strengthen future applications, incorporating fidelity monitoring is recommended to ensure consistent implementation of the sleep care bundle and to optimize its effectiveness in clinical practice.
by Prakasit Tonchoy, Nestor Asiamah, Rufus Akintimehin, Pannawadee Singkaew
Occupational exposure to polycyclic aromatic hydrocarbons (PAHs) has been associated with adverse health effects, yet evidence on the cognitive consequences of such exposure remains fragmented and has not been systematically synthesized across occupational groups. This protocol outlines a systematic review that will examine the relationship between occupational PAH exposure and cognitive impairment across eight predefined occupational categories. Relevant studies will be identified through electronic searches of major databases, including PubMed, Web of Science, Scopus, Embase, ProQuest, PsycINFO, CINAHL, the Cochrane Library, and Google Scholar. Eligible studies must assess PAH exposure in occupational settings and evaluate cognitive outcomes using validated instruments, with domain-specific neuropsychological tests prioritized as primary outcomes and global screening tools (e.g., MoCA, MMSE) included as supportive outcomes. Both observational and comparative study designs will be considered. Titles and abstracts will be screened by two independent reviewers, and full texts of potentially eligible articles will be assessed using predefined criteria. Data will be synthesized narratively, with contingency meta-analysis conducted where sufficient comparable data are available and heterogeneity is acceptable. Prespecified subgroup analyses will be undertaken by occupational category, biomarker, cognitive domain, and exposure context, with meta-regression considered if an adequate number of studies are identified. Risk of bias will be assessed using JBI tools at the study level and ROBIS at the review level, with planned sensitivity analyses. The review will consolidate current evidence on PAH-related cognitive outcomes across occupational groups, including under-studied populations such as wildland firefighters, and will inform occupational health policy, workplace screening initiatives, and future research aimed at safeguarding cognitive health in exposed populations.Preventing loss of autonomy has become a public health issue due to the increase in healthcare costs associated with ageing. It has become even more pressing with the arrival of the baby-boomer generation. This has given rise to several initiatives. This is the background to the VIVADOM project. The project provides a complete kit for older adults aged 60 years and over living at home. First, the kit includes a technological package (telecare, light path and digital tablet). Then, these older adults benefit from personalised human support provided by postal workers trained in gerontology. The aim of this study will be to carry out a health economic assessment (HEA) of the VIVADOM project as part of the prevention of frailty and/or dependency (by comparing beneficiaries of the complete kit with non-beneficiaries). The comparator will be the fact of not benefiting from the complete kit. In addition, the efficiency of the project in preventing falls and cognitive problems will be studied. We will calculate three incremental cost-effectiveness ratios (ICER) for these three issues.
The economic model used will be the Markov model. Transition probabilities, average costs and average quality-adjusted life year (QALY) will be calculated for the two groups being compared. The ICER will be obtained by dividing the difference in average costs by the difference in average QALYs. Finally, ICERs will be compared with willingness-to-pay (WTP) to assess the efficiency of the system. Thus, the VIVADOM project will be efficient when these ICERs are lower than the WTP. Univariate and probabilistic sensitivity analysis will be carried out to ensure the robustness of the analysis results.
The HEA of the VIVADOM project has been approved by the research unit of the University of Limoges in France. The results will be published in a peer-reviewed journal and presented at relevant national and international conferences.
To assess the extent to which cancer centres in Arab countries adhere to the 2016 American Society of Clinical Oncology/Oncology Nursing Society (ASCO/ONS) chemotherapy administration safety standards.
Multicentre cross-sectional survey.
Sample of the largest cancer treatment facilities across 10 Arab countries, including governmental, private, university-affiliated and daycare centres where chemotherapy is administered.
A multidisciplinary team of healthcare professionals (including head nurses, oncologists, oncology pharmacists and quality staff) at each centre completed a structured survey on adherence to the ASCO/ONS chemotherapy administration safety standards.
The primary outcome was the proportion of cancer centres fully implementing each of the 46 ASCO/ONS safety standards, grouped into four domains: (1) creating a safe environment—staffing and general policy; (2) treatment planning, patient consent and education; (3) ordering, preparing, dispensing and administering chemotherapy; and (4) monitoring after chemotherapy administration.
Of the 25 centres invited, 19 (76%) participated. The domain most frequently fully implemented was treatment planning, patient consent and education (12/19 centres, 63.2%). The remaining domains were fully implemented by four centres or fewer. The lowest implementation was observed for standards requiring policies for documentation and follow-up of patients who miss or cancel scheduled visits or chemotherapy treatments. Centres accredited by the Joint Commission International and those that specifically reported adherence to internationally recognised oncology guidelines were more likely to fully implement specific domains of the ASCO/ONS chemotherapy administration safety standards.
Significant gaps exist in the implementation of ASCO/ONS chemotherapy administration safety standards at cancer centres across Arab countries. These findings highlight opportunities for targeted interventions and policy development to improve chemotherapy safety in the region.
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