scholarly journals Impact and acceptability of HIV self-testing for trans men and trans women: A mixed-methods subgroup analysis of the SELPHI randomised controlled trial and process evaluation in England and Wales

2021 ◽  
Vol 32 ◽  
pp. 100700
Author(s):  
T. Charles Witzel ◽  
Talen Wright ◽  
Leanne McCabe ◽  
Michelle M. Gabriel ◽  
Aedan Wolton ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Subgroup Analysis ◽  
Controlled Trial ◽  
England And Wales ◽  
Trans Men ◽  
Self Testing ◽  
Trans Women ◽  
Randomised Controlled

Self-testing for HIV could increase diagnoses in the trans community

BMJ ◽  
2021 ◽  
pp. n2633
Author(s):  
Helen Saul ◽  
Deniz Gursul
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Subgroup Analysis ◽  
Controlled Trial ◽  
England And Wales ◽  
Trans Men ◽  
Trans People ◽  
Self Testing ◽  
Randomised Controlled

The study Witzel TC, Wright T, McCabe L, et al. Impact and acceptability of HIV self-testing for trans men and trans women: A mixed-methods subgroup analysis of the SELPHI randomised controlled trial and process evaluation in England and Wales. EClinicalMedicine 2021;32:100700. To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/hiv-self-testing-increases-diagnoses-trans-people/

Understanding implementation factors and participant experiences of a cluster randomised controlled trial to prevent falls among older Aboriginal people: a process evaluation protocol

2021 ◽  
pp. injuryprev-2020-043980
Author(s):  
Rona Macniven ◽  
Julieann Coombes ◽  
Roland Wilson ◽  
Aaron Simon ◽  
Tamara Mackean ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Aboriginal People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mixed Methods Design ◽  
Programme Implementation ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionProcess evaluations examining programme implementation are often conducted in conjunction with effectiveness studies. Their inclusion in studies with Aboriginal participants can give an understanding of programme delivery in Aboriginal community contexts. The Ironbark: Standing Strong and Tall programme was codesigned with Aboriginal communities and includes exercise and facilitated ‘yarning’ discussion about fall risk and prevention strategies. The programme pilot showed favourable outcomes and acceptability for Aboriginal people aged 45 years and over. The Ironbark: Standing Strong and Tall programme is now being compared with a ‘Healthy Community’ programme in a cluster randomised controlled trial within Aboriginal health and community services. An embedded process evaluation aims to explore relationships between participation and programme outcomes and the quality of programme implementation.Methods and analysisThe process evaluation will use a mixed methods design, guided by Indigenous research methodology. It will evaluate quantitative data (number of completed sessions, site coaching checklist tool, participant and facilitator questionnaire data and a participant habit formation scale), as well as qualitative data (open-ended responses from project and site staff and semistructured interviews using yarning with study participants and site managers). A programme logic model was developed to explain the intended inputs, activities, outputs and outcomes, which guided this process evaluation design.ConclusionThis process evaluation of a fall prevention programme for older Aboriginal people using a mixed methods design and data triangulation will allow for a comprehensive understanding of study findings. Multiple study sites allow for generalisability of findings and exploration of variation across sites.Trial registration numberACTRN12619000349145.

scholarly journals Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026039 ◽  
Author(s):  
Julia Frost ◽  
Jennifer Wingham ◽  
Nicky Britten ◽  
Colin Greaves ◽  
Charles Abraham ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Intervention Fidelity ◽  
Reduced Ejection Fraction ◽  
Randomised Controlled

ObjectiveTo identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.DesignMixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).SettingFour centres in the UK (Birmingham, Cornwall, Gwent and York).ParticipantsPeople with heart failure with reduced ejection fraction (HFrEF) and their caregivers.MethodsThe REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.Outcome measuresQuantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.ResultsIntervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.ConclusionsBy combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.Trial registration numberISRCTN25032672; Pre-results.

scholarly journals Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anne Christin Rahn ◽  
Lisa Wenzel ◽  
Andrea Icks ◽  
Alexander Stahmann ◽  
Jutta Scheiderbauer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Decision Making ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Web Based ◽  
Link Type ◽  
Oral Corticosteroids ◽  
Randomised Controlled

Abstract Introduction Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. Methods The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. Discussion We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management. Trial registration ClinicalTrials.govNCT04233970. Registered on 18 January 2020

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

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