1,720,971 research outputs found
COPD patients’ attitudes towards Chinese herbal medicine for the treatment of acute exacerbations: a qualitative study
No full textStudies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
No full textBackground: trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research.Methods: in November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings.Results: 125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them.Conclusions: this study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work
Role, function, and expectations of research funding committees: perspectives from committee members
Full text linkResearch funding committees play an integral role in the research funding process, consisting of a range of skills, knowledge, and expertise (e.g., professional, and public contributors). Although there is some evidence that has explored the efficiency and effectiveness of funding committees in terms of the funding process, there is a lack of published evidence about the purpose, role, and function of funding committees, from the perspective of committee members.A subset of survey data from a cohort of six National Institute for Health and Care Research (NIHR) research programmes, exploring the purpose of a funding committee, and the expectations and role of a funding committee member between October 2020 to December 2021. All committee members were eligible to participate in the survey.Using an inductive approach, 50 completed responses (22.5% response rate) were analysed, focusing on the role of a funding committee member and the functions of a funding committee. Participants highlighted seven key areas for the purpose of a funding committee: prioritising and recommending what research to fund (n=36) and assessment of quality (n=24) being the most common responses. Four areas were considered important to the expectations and role of funding committee members, with reviewing, critically appraising, and discussing applications (n=44); and being fair, objective, and unbiased (n=27) being the most common responses.The findings offer a unique insight into committee members’ expectations about the role, purpose and function of a funding committee and their contribution to the funding recommendation process. There was high agreement that the purpose and role of committees and their members was to offer expert advice to make fair, impartial decisions on which research should be prioritised. Exploring the purpose, role, and function of funding committees has relevance and importance for funding organisations seeking to enhance and optimise the decision-making practice of funding committees
Exploring virtual funding committee practices in the allocation of National Institute for Health and Care Research funding: a netnographic study
Full text linkObjectives: funding committees, comprising members with a range of knowledge, skills, and experience, are considered integral to the decision-making process of funding organisations for recommending or allocating research funding. However, there is limited research investigating the decision-making processes, the role of members and their social interactions during funding committee meetings conducted both virtually and face-to-face.Methods: using a mixed-methods design and following netnography principles, the study observed nine National Institute for Health and Care Research programmes funding committee meetings conducted virtually during October 2020 to December 2021; complemented by interviews with committee chairs and members (18 interviews) and NIHR staff (12 interviews); an online survey (50 responses); and documentary analysis. Personal reflections through immersive journals also formed part of the analysis.Results: three main themes were identified from the observations, interviews, and online survey: efficiency of virtual committee meetings (importance of preparation, and the role of formality, process, and structure); understanding the effect of virtual committee meetings on well-being (effects of fatigue and apprehension, and the importance of work life balance); and, understanding social interactions and engagement (levels of engagement, contribution and inclusivity, awareness of unconscious bias and the value of social networking).Conclusions: examining the decision-making practices of one funding organisation across several research programmes, across multiple committee meetings over one year has generated new insights around funding committee practices that previous studies have not been able to explore or investigate. Overall, it was observed that fair and transparent funding recommendations and outcomes can be achieved through virtual funding committees. However, whilst virtual funding committees have many benefits and opportunities, such as the potential to increase membership diversity and inclusivity, and be more environmentally sustainable, more evidence is needed to evaluate their effectiveness, with particular focus on issues of fatigue, engagement, and committee cohesion, especially when new committee members join
Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial
No full textBackground: hot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice.Methods: qualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs.Results: BCNs (n=8), managers (n=2), surgeons (n=3) and trial participants (n=8) from six sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments.Conclusions: both healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support.Trial registration: NCT02623374 – Last updated 07/12/2015 on ClinicalTrials.gov PR
Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial
No full textAbstract Background Hot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice. Methods Qualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs. Results BCNs (n = 10), managers (n = 2), surgeons (n = 3) and trial participants (n = 8) across six recruiting sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments and organisational priorities. Conclusions Both healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support. Trial registration NCT02623374 – Last updated 07/12/2015 on ClinicalTrials.gov PRS.</span
Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial
No full textBackground: The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferences of the public to inform trial methodologies that appeal to different populations. We report participant experiences of SAFA, a partially decentralised randomised clinical trial, to inform the methodology used in future dermatology trials that aim to appeal to women aged 18 and over. Methods: Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g. social media advertising), in addition to the decentralised trial visit and data collection methods used throughout. Interviews were conducted remotely, recorded, and transcribed. Data were analysed using reflexive thematic analysis. Results: Twelve SAFA participants (all women, age range 22–36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel valued and enabled them to engage in the trial with minimal interference to existing commitments. SAFA participants were generally accepting of trial demands, such as the text-heavy paperwork and on-site visits for blood collection and highlighted several areas relevant for trial conduct going forwards including where decentralised methods may (and may not) be accepted and how trial accessibility and understanding could be improved. Conclusions: The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralised methods should be considered favourably when designing a dermatology trial as they can potentially enhance both recruitment and retention. Trial registration number: ISRCTN 12892056. Registered on October 15, 2018.</p
The role of intersectionality in shaping participant engagement with health research through digital methods : findings from a qualitative study
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Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
Full text linkFunding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the Trials Methodology Research Partnership (MR/S014357/1). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.Peer reviewe
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