Exploring virtual funding committee practices in the allocation of National Institute for Health and Care Research funding: A netnographic study.

Background: 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); 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.

Mapping Theories, Models, and Frameworks to Evaluate Digital Health Interventions: Scoping Review.

BACKGROUND: Digital health interventions (DHIs) are a central focus of health care transformation efforts, yet their uptake in practice continues to fall short of their potential. In order to achieve their desired outcomes and impact, DHIs need to reach their target population and need to be used. Many factors can rapidly intersect between this dynamic of users and interventions. The application of theories, models, and frameworks (TMFs) can facilitate the systematic understanding and explanation of the complex interactions between users, practices, technology, and health system factors that underpin research questions. There remains a gap in our understanding of how TMFs have been applied to guide the evaluation of DHIs with real-world health system operations. OBJECTIVE: This study aims to map TMFs used in studies to guide the evaluation of DHIs. The objectives are to (1) describe the TMFs and the constructs they target, (2) identify how TMFs have been prospectively used (ie, their roles) in primary studies to evaluate DHIs, and (3) to reflect on the relevance and utility of our findings for knowledge users. METHODS: This scoping review was conducted in partnership with knowledge users using an integrated knowledge translation approach. We included papers (eg, reports; empirical quantitative, qualitative, and mixed methods studies; conference proceedings; and dissertations) if primary insights resulting from the application of TMFs were presented. Any type of DHI was eligible. Papers published from 2000 and onward were mainly identified from the following databases: MEDLINE (Ovid), CINAHL Complete (EBSCOhost), PsycINFO (Ovid), EBM Reviews (Ovid), and Embase (Ovid). RESULTS: A total of 156 studies published between 2000 and 2022 were included. A total of 68 distinct TMFs were identified across 85 individual studies. In more than half (85/156, 55%) of the included studies, 1 of following 6 prevailing TMFs were reported: Consolidated Framework for Implementation Research (n=39); the Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework (n=17); the Technology of Acceptance Model (n=16); the Unified Theory on Acceptance and Use of Technology (n=12); the Diffusion of Innovation Theory (n=10); and Normalization Process Theory (n=9). The most common intended roles of the 6 TMFs were to inform data collection (n=86), to inform data analysis (n=69), and to identify key constructs that may serve as barriers and facilitators (n=52). CONCLUSIONS: As TMFs are most often reported to be applied to support data collection and analysis, researchers should consider more clearly synthesizing key insights as practical use cases to both increase the relevance and digestibility of their findings. There is also a need to adapt or develop guidelines for better reporting DHIs and the use of TMFs to guide evaluation. Hence, it would contribute to ensuring ongoing technology transformation efforts are evidence and theory informed rather than anecdotally driven.

Treating acute exacerbations of COPD with Chinese herbal medicine to aid antibiotic use reduction (Excalibur): a randomised double-blind, placebo-controlled feasibility trial.

Background: Although many acute exacerbations of COPD (AECOPD) are triggered by non-bacterial causes, they are often treated with antibiotics. Preliminary research suggests that the Chinese herbal medicine "Shufeng Jiedu" (SFJD), may improve recovery and therefore reduce antibiotic use in patients with AECOPD. Aims: To assess the feasibility of conducting a randomised placebo-controlled clinical trial of SFJD for AECOPD in UK primary care. Methods: GPs opportunistically recruited patients experiencing an AECOPD. Participants were randomised 1:1 to usual care plus SFJD or placebo for 14 days. Participants, GPs and research nurses were blinded to treatment allocation. GPs could prescribe immediate, delayed or no antibiotics, with delayed prescribing encouraged where appropriate. Participants were asked to complete a participant diary, including EXACT-PRO and CAT™ questionnaires for up to 4 weeks. Outcomes included recruitment rate and other measures of study feasibility described using only descriptive statistics and with no formal comparisons between groups. We also conducted qualitative interviews with recruited and non-recruited COPD patients and clinicians, analysed using framework analysis. Results: Over 6 months, 19 participants (6 SFJD, 13 placebo) were recruited. Sixteen (84%) participants returned diaries or provided a diary by recall. Overall, 1.3 participants were recruited per 1,000 patients on the COPD register per month open. Median duration of treatment was 9.8 days in the intervention group vs 13.3 days in the placebo group. The main reason for discontinuation in both groups was perceived side-effects. in both groups. Point estimates for both the EXACT-PRO and CAT™ outcomes suggested possible small benefits of SFJD. Most patients and clinicians were happy to try SFJD as an alternative to antibiotics for AECOPD. Recruitment was lower than expected because of the short recruitment period, the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from "rescue packs" before seeing their GP, and workforce challenges in primary care. Conclusion: Recruitment was impaired by the COVID-19 pandemic. Nevertheless, we were able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges such as including the trial medication in COPD patients' "rescue packs" and delegating recruitment to a central trials team. Clinical Trial Registration: Identifier, ISRCTN26614726.

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.

BACKGROUND: 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.

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.

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.

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

BACKGROUND: Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT. METHODS: MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed. DISCUSSION: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice. TRIAL REGISTRATION: ISRCTN reference 58720120 . Registered 13 December 2022.