General dental practitioners (GDPs) regularly prescribe antibiotics to manage dental infections although most infections can be treated successfully by local measures. Published guidance to support GDPs to make appropriate prescribing decisions exists but there continues to be wide variation in dental antibiotic prescribing. An interview study was conducted as part of the Reducing Antibiotic Prescribing in Dentistry (RAPiD) trial to understand the barriers and facilitators of using local measures instead of prescribing antibiotics to manage bacterial infections. Thirty semi-structured one-to-one telephone interviews were conducted using the Theoretical Domains Framework (TDF). Responses were coded into domains of the TDF and sub-themes. Priority domains (high frequency: ≥50 % interviewees discussed) relevant to behaviour change were identified as targets for future intervention efforts and mapped onto ‘intervention functions’ of the Behaviour Change Wheel system. Five domains (behavioural regulation, social influences, reinforcement, environmental context and resources, and beliefs about consequences) with seven sub-themes were identified as targets for future intervention. All participants had knowledge about the evidence-based management of bacterial infections, but they reported difficulties in following this due to patient factors and time management. Lack of time was found to significantly influence their decision processes with regard to performing local measures. Beliefs about their capabilities to overcome patient influence, beliefs that performing local measures would impact on subsequent appointment times as well as there being no incentives for performing local measures were also featured. Though no knowledge or basic skills issues were identified, the participants suggested some continuous professional development programmes (e.g. time management, an overview of published guidance) to address some of the barriers. The domain results suggest a number of intervention functions through which future interventions could change GDPs’ antibiotic prescribing for bacterial infections: imparting skills through training, providing an example for GDPs to imitate (i.e. modelling) or creating the expectation of a reward (i.e. incentivisation). This is the first theoretically informed study to identify barriers and facilitators of evidence-based management of patients with bacterial infections among GDPs. A pragmatic approach is needed to address the modifiable barriers in future interventions intended to change dentists’ inappropriate prescribing behaviour.

Background Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications. Methods and analysis C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot). Primary outcome measure Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation. The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months. Secondary outcome measures Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation. A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used. The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021. Statistical analysis Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs. Ethics and dissemination The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals. Trial registration number ISRCTN55215960; pre-results.

Non-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and loss to follow-up and thus outcome data cannot be obtained. The majority of existing interventions targeting retention fail to describe any theoretical basis for the observed improvement, or lack of improvement. Moreover, most of these interventions lack involvement of participants in their conception and/or design, raising questions about their relevance and acceptability. Many of the causes of non-retention involve people performing a behaviour (e.g. not returning a questionnaire). Behaviour change is difficult, and the importance of a strong theoretical basis for interventions that aim to change behaviour is increasingly recognised. This research aims to develop and pilot theoretically informed, participant-centred, evidence-based behaviour change interventions to improve retention in trials. This research will generate data through semi-structured interviews on stakeholders’ perspectives of the reasons for trial non-retention. It will identify perceived barriers and enablers to trial retention using the Theoretical Domains Framework. The intervention development work will involve identification of behaviour change techniques, using recognised methodology, and co-production of retention interventions through discussion groups with end-users. An evaluation of intervention acceptability and feasibility will be conducted in focus groups. Finally, a ready-to-use evaluation framework to deploy in Studies Within A Trial as well as an explanatory retention framework will be developed for identifying and tackling modifiable issues to improve trial retention. We believe this to be one of the first studies to apply a theoretical lens to the development of interventions to improve trial retention that have been informed by, and are embedded within, participants’ experiential accounts. By developing and identifying priority interventions this study will support efforts to reduce research waste.

Background: The national breast screening programme in the United Kingdom is under pressure due to workforce shortages and having been paused during the COVID-19 pandemic. Artificial intelligence has the potential to transform how healthcare is delivered by improving care processes and patient outcomes. Research on the clinical and organisational benefits of artificial intelligence is still at an early stage, and numerous concerns have been raised around its implications, including patient safety, acceptance, and accountability for decisions. Reforming the breast screening programme to include artificial intelligence is a complex endeavour because numerous stakeholders influence it. Therefore, a stakeholder analysis was conducted to identify relevant stakeholders, explore their views on the proposed reform (i.e., integrating artificial intelligence algorithms into the Scottish National Breast Screening Service for breast cancer detection) and develop strategies for managing ‘important’ stakeholders. Methods: A qualitative study (i.e., focus groups and interviews, March-November 2021) was conducted using the stakeholder analysis guide provided by the World Health Organisation and involving three Scottish health boards: NHS Greater Glasgow & Clyde, NHS Grampian and NHS Lothian. The objectives included: (A) Identify possible stakeholders (B) Explore stakeholders’ perspectives and describe their characteristics (C) Prioritise stakeholders in terms of importance and (D) Develop strategies to manage ‘important’ stakeholders. Seven stakeholder characteristics were assessed: their knowledge of the targeted reform, position, interest, alliances, resources, power and leadership. Results: Thirty-two participants took part from 14 (out of 17 identified) sub-groups of stakeholders. While they were generally supportive of using artificial intelligence in breast screening programmes, some concerns were raised. Stakeholder knowledge, influence and interests in the reform varied. Key advantages mentioned include service efficiency, quicker results and reduced work pressure. Disadvantages included overdiagnosis or misdiagnosis of cancer, inequalities in detection and the self-learning capacity of the algorithms. Five strategies (with considerations suggested by stakeholders) were developed to maintain and improve the support of ‘important’ stakeholders. Conclusions: Health services worldwide face similar challenges of workforce issues to provide patient care. The findings of this study will help others to learn from Scottish experiences and provide guidance to conduct similar studies targeting healthcare reform. Study registration: researchregistry6579, date of registration: 16/02/2021.

Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprising generic Weight Watchers® referral offered to women treated for breast cancer with or without additional breast cancer-tailored dietetic support is feasible and shows promise for improving weight and quality of life (QoL). Participants were randomly allocated to 3 groups: Weight Watchers® referral (for 12 sessions of meetings and digital tools) plus 5 breast cancer-tailored dietitian-led group support sessions (WW Plus: n = 14), Weight Watchers® referral only (WW: n = 16) or control (Weight Watchers® referral after 3 months, n = 15). Feasibility was assessed based on retention rate, recruitment and randomisation process, meeting attendance, suitability of the setting and outcome measurement tools, unintended consequences, cost and observations of the dietetic sessions. Outcomes were measured at 0, 3 (‘trial exit’) and 12 months post intervention. The response rate to the invitation was 43% (140/327) of whom 58 were eligible and 45 (median age 61.0 years; body mass index 30.2 kg/m2) were randomised. Data from 38 (84%) and 30 (67%) participants were available at trial exit and 12 months respectively. Feasibility issues included slow recruitment process, lack of blinding throughout, weighing scales not measuring > 150 kg, lack of clear instructions for completing QoL questionnaire and workload and time pressures in delivering dietetic sessions. Participants had good attendance rate at group meetings and no serious unintended consequences were reported. WW Plus was most expensive to run. Mean (95% CI) weight change at trial exit was − 3.67 kg (− 5.67, − 2.07) in WW Plus, − 6.03 kg (− 7.61, − 4.44) in WW group and + 0.19 kg (− 1.45, + 1.83) in control group. About 40% of the WW Plus, 64% of the WW group and 56% of the control group lost ≥ 5% of their baseline weight by 12 months. All groups showed promise for improving QoL at trial exit but only the WW group maintained significant improvements from baseline at 12 months. The trial procedures were feasible, with some modifications. This pilot trial indicates the benefits of providing free WW vouchers for weight loss maintenance and improving QoL but provided no evidence that including additional dietetic support would add any extra value. Further research with WW with long-term follow-up should be undertaken to assess weight loss sustainability and benefit on health outcomes in this patient group. ISRCTN-29623418 .

Poor recruitment and retention are widely reported as problematic for many randomized controlled trials (RCTs). However, there is limited evidence on the context-specific challenges faced by trial staff recruiting to mental health trials. Consequently, evidence to inform effective interventions that could support trial staff in mental health trials is lacking. To address this gap, an evidence synthesis is needed to better understand the experiences and influences on trial staff recruiting to mental health RCTs to inform the development of strategies for improvement. This article aims to address this gap by synthesizing the qualitative evidence on trial staff (eg, clinicians, researchers) experiences of recruitment and retention to mental health RCTs (trials where mental health is the primary indication under investigation). A rapid qualitative evidence synthesis (rQES) was conducted in accordance with rQES guidance and Thomas and Harden's approach to thematic synthesis. We searched MEDLINE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials, Social Science Citation Index, and Applied Social Sciences Index and Abstracts, Web of Science, as well as key reviews and gray literature. Altogether, 4253 records were screened, resulting in 33 full-text reviews, of which 15 were eligible for inclusion. Confidence was assessed using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual). The review protocol is publicly available (PROSPERO: CRD42024601854). All studies reported on recruitment, with only one briefly reporting retention data alongside recruitment; therefore, findings of this review focus on recruitment to mental health trials. We identified 4 interrelated analytical themes capturing the influences on trial staff recruiting to mental health trials, extending beyond organizational and trial eligibility issues: (1) recruitment within existing care pathways; (2) understanding and judgments of RCTs and interventions; (3) weighing decisions to approach patients; and (4) engaging in trial conversations. Findings from this rQES highlight the complex interplay of factors shaping the context-specific challenges faced by trial staff recruiting to mental health trials. Specific concerns that trial participation could destabilize some patients, disrupt care, undermine therapeutic relationships, or trigger risk-taking behavior were identified as impacting recruitment. Findings highlight key recruitment challenges for trialists to consider in developing interventions to better support staff recruiting to mental health trials.