Conectar
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.
Diets high in ultraprocessed food (UPF) are associated with poor health outcomes and weight gain. Healthcare workers are particularly at risk of consuming diets high in UPF due to erratic work patterns, high stress and limited access to fresh food at work. Despite this, no interventions to date have specifically targeted a reduction in UPF intake in healthcare workers.
This article describes the development and content of a 6-month behavioural support intervention targeting a reduction in UPF intake in UK healthcare workers. The intervention was offered to all participants who took part in the UltraProcessed versus minimally processed Diets following UK dietAry guidance on healTh outcomEs trial—a two-stage study in which Stage 1 was a controlled-feeding crossover randomised controlled trial of provided UPF versus minimally processed food (MPF) diets (published previously) and was completed before the start of Stage 2. Stage 2, reported here, aimed to support participants to reduce their UPF consumption, increase MPF and increase physical activity in real-world settings. The intervention was developed using the behaviour change wheel framework, which systematically links behavioural diagnoses to intervention functions, incorporating the capability, opportunity and motivation model for behaviour change. It included tailored one-to-one and group support sessions, bespoke digital and print resources and a mobile-optimised website. The detailed description is intended to support future replication and adaptation. The acceptability and feasibility of the intervention will be assessed using quantitative and qualitative data in a future paper.
Sheffield Research Ethics Committee approved the trial (22/YH/0281). Findings will be disseminated through peer-reviewed publications, conference presentations and summaries shared with participants and stakeholders.
Frequent haemodialysis creates close-knit communities within treatment units, where high patient mortality contributes to significant grief among patients and staff. Despite the emotional toll, support for grief and bereavement in these settings remains limited, and recent data are lacking. This scoping review aims to explore how patients and nursing staff within haemodialysis units experience and cope with bereavement, and to identify support strategies currently used or desired to inform future, culturally sensitive approaches, particularly in Australia.
Scoping review conducted in accordance with the Joanna Briggs Institute methodology.
A comprehensive search was conducted using the Clinical Information Access Portal, supplemented by grey literature and the Elicit AI Research Assistant tool.
We included literature exploring patient and nurse perspectives on grief and bereavement in haemodialysis units. Studies outside the haemodialysis setting and non-English studies were excluded. There were no geographical or publication year limitations.
Two reviewers independently screened titles, abstracts and full texts, with discrepancies resolved by consensus. A data extraction table was used to collect study characteristics and key findings. Thematic analysis was applied to synthesise data across studies.
17 publications from 1998 to 2021 were identified across five countries. Grief and bereavement following patient death profoundly shape haemodialysis unit dynamics. Patients form familial bonds and experience deep grief when peers die, while nurses face emotional stress and burnout. Reported support strategies include memorial services, peer and staff support, counselling and debriefing and spiritual care.
This study describes grief experiences, support strategies and cultural implications in haemodialysis units, which serve a culturally diverse group of people. By consolidating available knowledge, this review provides a critical platform for future empirical work and calls for culturally sensitive support and larger, diverse samples in future research.
Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.
The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.
Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.
This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.
Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.
The high prevalence of loneliness in young people, aged 10–24 years, is increasingly recognised as an urgent global health concern. The experience of loneliness is linked to a wide range of adverse physical and mental health outcomes. A lack of loneliness scales that can accurately capture the authentic experiences of young people has hampered progress in our understanding of the aetiology and sequelae of youth loneliness, as well as the development of preventative policies and interventions. Here, we provide a protocol for developing and validating an age-sensitive loneliness scale for young people aged 10–24 years: the Youth Loneliness Scale (YLS). The scale is designed to measure loneliness in the general population of young people in the UK.
The scale is coproduced with young people from design to dissemination. The scale development process follows a three-phased, multistep approach that includes item development, scale construction and scale evaluation. Item development is achieved via deductive (literature review) and inductive methods (arts workshops and focus groups), as well as a Delphi survey of experts (by profession and experience) for initial refinement. The scale is then constructed via pretesting items in cognitive interviews with young people, and exploratory testing for preliminary evaluation and refinement. Finally, the scale is administered in confirmatory testing, where a full psychometric evaluation is provided.
The project was approved by the Queen Mary University of London Research Ethics Committee (Reference: 2024-0231-341) as the lead site and subsequently endorsed by the University of Manchester Research Ethics Committee. The YLS scale and results of its psychometric evaluation will be published open-access. The protocol provided here will allow researchers to evaluate the final scale generated against the plans set out. We also encourage the use and adaptation of the protocol to develop age-sensitive loneliness scales for other populations.
FreshRSS 