A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. METHODS: This was a multi-site, exploratory, two-arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. RESULTS: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3-month and 70 (88.6%) at 6-month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire-12), QoL (work and social adjustment scale), health-related QoL (functional assessment of cancer therapy[FACT] general and FACT-ES-19/23), distress (generalised anxiety disorder -7, patient health questionnaire-9) and psychological flexibility (valuing questionnaire). CONCLUSIONS: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. TRIAL REGISTRATION: ISRCTN12027752.

Opportunities to improve feedback to reduce blood component wastage: Results of a national scheme evaluation.

BACKGROUND: Blood components are costly and scarce. The Blood Stocks Management Scheme (BSMS) was established in the United Kingdom (UK) to support hospital transfusion services and national blood services through collection, analysis, and monthly feedback of data on blood component inventory and wastage management. There is a growing evidence base on how best to deliver feedback for quality improvement. We assessed the quality and utility of the monthly BSMS component reports. METHODS: We assessed the content of BSMS reports issued in March 2023 against established criteria for effective feedback. Two researchers independently rated whether criteria spanning the five domains of goal setting, data collection, feedback content, feedback display and feedback delivery were fully, partially or not met. Disagreements were resolved through discussion. We conducted an online questionnaire survey of recipients of BSMS reports during March 2023 to assess their use of reports and seek suggestions for improvement. RESULTS: Five out of 20 criteria for effective feedback were fully met. Areas for improvement included placing more emphasis in the feedback on positive change, linking data and summary messages, and including specific suggestions for action. Respondents highlighted the value of benchmarked comparisons with other hospital transfusion services. CONCLUSION: There is scope for enhancing the effectiveness and utility of BSMS feedback reports and hence reducing wastage of blood components. This methodology for evaluation of feedback could be utilized to improve other areas of transfusion practice.

PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial.

BACKGROUND: Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic changes in health because of relatively small problems. Older people with frailty are at increased risk of adverse outcomes including disability, hospitalisation, and care home admission, with associated reduction in quality of life and increased NHS and social care costs. Personalised Care Planning offers an anticipatory, preventative approach to supporting older adults to live independently for longer, but it has not been robustly evaluated in a population of older adults with frailty. METHODS: Following an initial feasibility study, this multi-centre, individually randomised controlled trial aims to establish whether personalised care planning for older people improves health-related quality of life. It will recruit 1337 participants from general practices across Yorkshire and Humber and Mid-Mersey in the North of England. Eligible patients will be aged 65 and over with an electronic frailty index score of 0.21 or above, living in their own homes, without severe cognitive impairment and not in receipt of end-of-life care. Following confirmation of eligibility, informed consent and baseline data collection, participants will be individually randomised to the PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) intervention or usual care in a 2.6:1 allocation ratio. Participants will not be blinded to allocation, but data collection and analysis will be blinded. The intervention will be delivered over 12 weeks by a Personal Independence Co-ordinator worker based within a voluntary sector organisation, Age UK. The primary outcomes are health-related quality of life, measured using both the physical and mental components of the Short-Form 12 Item Health Questionnaire at 12 months after randomisation. Secondary outcomes comprise activities of daily living, self-management capabilities and loneliness, admission to care homes, hospitalisations, and health and social care resource use at 12 months post randomisation. Parallel cost-effectiveness and process evaluations will be conducted alongside the trial. DISCUSSION: The PROSPER study will evaluate the effectiveness and cost-effectiveness of a personalised care planning approach for older people with frailty and inform the process of its implementation. TRIAL REGISTRATION: ISRCTN16123291 .  Registered on  28 August 2020.

Qualitative research in dental traumatology-A narrative review.

This review highlights the recent contributions of qualitative research in advancing understanding of dental trauma injury and the barriers and enablers to guide policy for improved patient-centred care including transitional care. It summarises the common approaches and methods used and outlines the key factors that guide the appraisal of qualitative studies. It highlights the importance of the application of qualitative research methods in dental research to generate rich and detailed data to provide explanations and insights into people's experiences, beliefs and attitudes and the complexity of human decision-making and behaviour. In the past decade while there have been a growing number of publications of qualitative studies in dental journals, qualitative studies remain a small percentage of the published dental traumatology research. This may be because of limited understanding about the background, methods and rigour of qualitative research.

Tailored implementation of national recommendations on fall prevention among older adults in municipalities in Norway (FALLPREVENT trial): a study protocol for a cluster-randomised trial.

BACKGROUND: Despite substantial research evidence indicating the effectiveness of a range of interventions to prevent falls, uptake into routine clinical practice has been limited by several implementation challenges. The complexity of fall prevention in municipality health care underlines the importance of flexible implementation strategies tailored both to general determinants of fall prevention and to local contexts. This cluster-randomised trial (RCT) investigates the effectiveness of a tailored intervention to implement national recommendations on fall prevention among older home-dwelling adults compared to usual practice on adherence to the recommendations in health professionals. METHODS: Twenty-five municipalities from four regions in Norway will be randomised to intervention or control arms. Each municipality cluster will recruit up to 30 health professionals to participate in the study as responders. The tailored implementation intervention comprises four components: (1) identifying local structures for implementation, (2) establishing a resource team from different professions and levels, (3) promoting knowledge on implementation and fall prevention and (4) supporting the implementation process. Each of these components includes several implementation activities. The Consolidated Framework for Implementation Research (CFIR) will be used to categorise determinants of the implementation process and the Expert Recommendations for Implementing Change (ERIC) will guide the matching of barriers to implementation strategies. The primary outcome measure for the study will be health professionals' adherence to the national recommendations on fall prevention measured by a questionnaire. Secondary outcomes include injurious falls, the feasibility of the intervention, the experiences of the implementation process and intervention costs. Measurements will be carried out at baseline in August 2023, post-intervention in May 2024 and at a follow-up in November 2024. DISCUSSION: This study will provide evidence on the effectiveness, intervention costs and underlying processes of change of tailored implementation of evidence-based fall prevention recommendations. TRIAL REGISTRATION: The trial is registered in the Open Science Registry: https://doi.org/10.17605/OSF.IO/JQ9T5 . Registered: March 03, 2023.

Patient influence on general practice service improvement decision making: a participatory research mixed-methods intervention study.

BACKGROUND: Health policy promotes patient participation in decision making about service organisation. In English general practice this happens through contractually required patient participation groups (PPGs). However, there are problems with the enactment of PPGs that have not been systematically addressed. AIM: To observe how a co-designed theory-informed intervention can increase representational legitimacy and facilitate power sharing to support PPGs to influence decision making about general practice service improvement. DESIGN AND SETTING: Participatory action research to implement the intervention in two general practices in the North of England was undertaken. The intervention combined two different participatory practices: partnership working involving externally facilitated meetings with PPG members and staff; and consultation with the wider patient population using a bespoke discrete choice experiment (DCE). METHOD: To illustrate decision making in PPGs, qualitative data are presented from participant observation notes and photographed visual data generated through participatory methods. The DCE results are summarised to illustrate how wider population priorities contributed to overall decision making. Observational data were thematically analysed using normalisation process theory with support from a multi-stakeholder co-research group. RESULTS: In both general practices, patients influenced decision making during PPG meetings and through the DCE, resulting in bespoke patient-centred action plans for service improvement. Power asymmetries were addressed through participatory methods, clarification of PPG roles in decision making, and addressing representational legitimacy through wider survey consultation. CONCLUSION: Combining participatory practices and facilitated participatory methods enabled patients to influence decision making about general practice service improvement. The policy of mandatory PPGs needs updating to recognise the need to resource participation in a meaningful way.

Acceptability of aspirin for cancer preventive therapy: a survey and qualitative study exploring the views of the UK general population.

OBJECTIVES: Aspirin could be offered for colorectal cancer prevention for the UK general population. To ensure the views of the general population are considered in future guidance, we explored public perceptions of aspirin for preventive therapy. DESIGN: We conducted an online survey to investigate aspirin use, and awareness of aspirin for cancer prevention among the UK general population. We conducted semistructured interviews with a subsample of survey respondents to explore participants' acceptability towards aspirin for cancer preventive therapy. We analysed the interview data using reflexive thematic analysis and mapped the themes onto the Theoretical Domains Framework, and the Necessity and Concerns Framework. SETTING: Online survey and remote interviews. PARTICIPANTS: We recruited 400 UK respondents aged 50-70 years through a market research company to the survey. We purposefully sampled, recruited and interviewed 20 survey respondents. RESULTS: In the survey, 19.0% (76/400) of respondents were aware that aspirin can be used to prevent cancer. Among those who had previously taken aspirin, 1.9% (4/216) had taken it for cancer prevention. The interviews generated three themes: (1) perceived necessity of aspirin; (2) concerns about side effects; and (3) preferred information sources. Participants with a personal or family history of cancer were more likely to perceive aspirin as necessary for cancer prevention. Concerns about taking aspirin at higher doses and its side effects, such as gastrointestinal bleeding, were common. Many described wanting guidance and advice on aspirin to be communicated from sources perceived as trustworthy, such as healthcare professionals. CONCLUSIONS: Among the general population, those with a personal or family history of cancer may be more receptive towards taking aspirin for preventive therapy. Future policies and campaigns recommending aspirin may be of particular interest to these groups. Multiple considerations about the benefits and risks of aspirin highlight the need to support informed decisions on the medication.

Priorities for implementation research on diagnosing cancer in primary care: a consensus process.

BACKGROUND: The early detection and diagnosis of cancer to reduce avoidable mortality and morbidity is a challenging task in primary health care. There is a growing evidence base on how to enable earlier cancer diagnosis, but well-recognised gaps and delays exist around the translation of new research findings into routine clinical practice. Implementation research aims to accelerate the uptake of evidence by health care systems and professionals. We aimed to identify priorities for implementation research in early cancer diagnosis in primary care. METHODS: We used a RAND/UCLA modified Delphi consensus process to identify and rank research priorities. We asked primary care physicians, patients and researchers to complete an online survey suggesting priorities for implementation research in cancer detection and diagnosis. We summarised and presented these suggestions to an 11-member consensus panel comprising nine primary care physicians and two patients. Panellists independently rated the importance of suggestions on a 1-9 scale (9 = very high priority; 1 = very low priority) before and after a structured group discussion. We ranked suggestions using median ratings. RESULTS: We received a total of 115 suggested priorities for implementation research from 32 survey respondents (including 16 primary care professionals, 11 researchers, and 4 patient and public representatives; 88% of respondents were UK-based). After removing duplicates and ineligible suggestions, we presented 37 suggestions grouped within 17 categories to the consensus panel. Following two rounds of rating, 27 suggestions were highly supported (median rating 7-9). The most highly rated suggestions concerned diagnostic support (e.g., access to imaging) interventions (e.g., professional or patient education), organisation of the delivery of care (e.g., communication within and between teams) and understanding variations in care and outcomes. CONCLUSIONS: We have identified a set of priorities for implementation research on the early diagnosis of cancer, ranked in importance by primary care physicians and patients. We suggest that researchers and research funders consider these in directing further efforts and resources to improve population outcomes.

Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies for IBS are ineffective, the UK National Institute for Health and Care Excellence guideline suggests considering low- dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown, and they are infrequently prescribed in this setting. METHODS: This randomised, double-blind, placebo-controlled trial (Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment [ATLANTIS]) was conducted at 55 general practices in England. Eligible participants were aged 18 years or older, with Rome IV IBS of any subtype, and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥75 points) despite dietary changes and first-line therapies, a normal full blood count and C-reactive protein, negative coeliac serology, and no evidence of suicidal ideation. Participants were randomly assigned (1:1) to low-dose oral amitriptyline (10 mg once daily) or placebo for 6 months, with dose titration over 3 weeks (up to 30 mg once daily), according to symptoms and tolerability. Participants, their general practitioners, investigators, and the analysis team were all masked to allocation throughout the trial. The primary outcome was the IBS-SSS score at 6 months. Effectiveness analyses were according to intention-to-treat; safety analyses were on all participants who took at least one dose of the trial medication. This trial is registered with the ISRCTN Registry (ISRCTN48075063) and is closed to new participants. FINDINGS: Between Oct 18, 2019, and April 11, 2022, 463 participants (mean age 48·5 years [SD 16·1], 315 [68%] female to 148 [32%] male) were randomly allocated to receive low-dose amitriptyline (232) or placebo (231). Intention-to-treat analysis of the primary outcome showed a significant difference in favour of low-dose amitriptyline in IBS-SSS score between groups at 6 months (-27·0, 95% CI -46·9 to -7·10; p=0·0079). 46 (20%) participants discontinued low-dose amitriptyline (30 [13%] due to adverse events), and 59 (26%) discontinued placebo (20 [9%] due to adverse events) before 6 months. There were five serious adverse reactions (two in the amitriptyline group and three in the placebo group), and five serious adverse events unrelated to trial medication. INTERPRETATION: To our knowledge, this is the largest trial of a tricyclic antidepressant in IBS ever conducted. Titrated low-dose amitriptyline was superior to placebo as a second-line treatment for IBS in primary care across multiple outcomes, and was safe and well tolerated. General practitioners should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration, such as the self-titration document developed for this trial. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme (grant reference 16/162/01).

Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial.

Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant's trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration: ISRCTN registry ( ISRCTN10487576, 16/12/2021).

BACKGROUND: The majority of women with early-stage breast cancer are recommended adjuvant endocrine therapy (AET) to reduce the chances of their cancer coming back. Many women given this medication don't take it every day or stop taking it earlier than they should. We have developed four different interventions to help women take AET. These are; text messages reminding women to take AET; an information leaflet explaining how AET works and its benefits and side-effects; a therapy programme to reduce distress, consisting of five support sessions and four module booklets; and a website with strategies to manage AET side-effects. We are now testing whether these interventions can be delivered within the NHS in different combinations, in a small trial. STUDY METHODS: We have three aims: 1. To find out if the interventions can be given and are received in the way they were supposed to (fidelity).2. To find out if the support received as part of the trial was acceptable to women with breast cancer (acceptability).3. To find out what women's experience was of taking part in the trial overall (trial experience). To do this we will: 1. Interview participants to ask them how acceptable they found the interventions, what they understood, whether they used the interventions, and how they found participating in the trial.2. Interview therapists who delivered the therapy programme to see if they delivered it as they were supposed to, and how they found delivering the intervention.3. Ask participants to complete questionnaires about how acceptable the interventions were, and whether they read and used them.4. Ask the staff involved in finding participants for the trial about challenges and improvements. We will use what we find to make improvements in a future trial where we will test whether the interventions help women to take AET.

Evaluating an intervention to improve the safety and experience of transitions from hospital to home for older people (Your Care Needs You): a protocol for a cluster randomised controlled trial and process evaluation.

BACKGROUND: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home. METHODS: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. DISCUSSION: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. TRIAL REGISTRATION: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

Understanding the organisational influences on the quality of and access to primary care in English prisons: a qualitative interview study.

BACKGROUND: Primary care for routine healthcare conditions is delivered to thousands of people in the English prison estate every day but the prison environment presents unique challenges to the provision of high-quality health care. Little research has focused on the organisational factors that affect quality of and access to prison health care. AIM: To understand key influences on the quality of primary care in prisons. DESIGN AND SETTING: This was a qualitative interview study across the North of England from 2019 to 2021. METHOD: Interviews were undertaken with 43 participants: 21 prison leavers and 22 prison healthcare professionals. Reflexive thematic analysis was undertaken. RESULTS: The overarching organisational issue influencing quality and access was that of chronic understaffing coupled with a workforce in flux and dependence on locum staff. This applied across different prisons, roles, and grades of staff, and was vocally discussed by both patient and staff participants. Intricately related to understaffing (and fuelled by it) was the propensity for a reactive and sometimes crisis-led service to develop that was characterised by continual firefighting. A persistent problem exacerbated by the above issues was unreliable communication about healthcare matters within some prisons, creating frustration. Positive commentary focused on the characteristics and actions of individual healthcare professionals. CONCLUSION: This study highlights understaffing and its consequences as the most significant threat to the quality of and access to prison primary care. Strategies to address health care affecting prison populations urgently need to consider staffing. This issue should receive high-profile and mainstream attention to address health inequalities.

The quality of prison primary care: cross-sectional cluster-level analyses of prison healthcare data in the North of England.

Background: Prisoners have significant health needs, are relatively high users of healthcare, and often die prematurely. Strong primary care systems are associated with better population health outcomes. We investigated the quality of primary care delivered to prisoners. Methods: We assessed achievement against 30 quality indicators spanning different domains of care in 13 prisons in the North of England. We conducted repeated cross-sectional analyses of routinely recorded data from electronic health records over 2017-20. Multi-level mixed effects logistic regression models explored associations between indicator achievement and prison and prisoner characteristics. Findings: Achievement varied markedly between indicators, prisons and over time. Achieved processes of care ranged from 1% for annual epilepsy reviews to 94% for blood pressure checks in diabetes. Intermediate outcomes of care ranged from only 0.2% of people with epilepsy being seizure-free in the preceding year to 34% with diabetes having sufficient blood pressure control. Achievement improved over three years for 11 indicators and worsened for six, including declining antipsychotic monitoring and rising opioid prescribing. Achievement varied between prisons, e.g., 1.93-fold for gabapentinoid prescribing without coded neuropathic pain (odds ratio [OR] range 0.67-1.29) and 169-fold for dried blood spot testing (OR range 0.05-8.45). Shorter lengths of stay were frequently associated with lower achievement. Ethnicity was associated with some indicators achievement, although the associations differed (both positive and negative) with indicators. Interpretation: We found substantial scope for improvement and marked variations in quality, which were largely unaltered after adjustment for prison and prisoner characteristics. Funding: National Institute for Health and Care Research Health and Social Care and Delivery Research Programme: 17/05/26.

The detection and management of attempted fraud during an online randomised trial.

BACKGROUND: Online studies offer an efficient method of recruiting participants and collecting data. Whilst delivering an online randomised trial, we detected unusual recruitment activity. We describe our approach to detecting and managing suspected fraud and share lessons for researchers. METHODS: Our trial investigated the single and combined effects of different ways of presenting clinical audit and feedback. Clinicians and managers who received feedback from one of five United Kingdom national clinical audit programmes were emailed invitations that contained a link to the trial website. After providing consent and selecting their relevant audit, participants were randomised automatically to different feedback versions. Immediately after viewing their assigned feedback, participants completed a questionnaire and could request a financial voucher by entering an email address. Email addresses were not linked to trial data to preserve participant anonymity. We actively monitored participant numbers, questionnaire completions, and voucher claims. RESULTS: Following a rapid increase in trial participation, we identified 268 new voucher claims from three email addresses that we had reason to believe were linked. Further scrutiny revealed duplicate trial completions and voucher requests from 24 email addresses. We immediately suspended the trial, improved security measures, and went on to successfully complete the study. We found a peak in questionnaires completed in less than 20 seconds during a likely contamination period. Given that study and personal data were not linked, we could not directly identify the trial data from the 268 duplicate entries within the 603 randomisations occurring during the same period. We therefore excluded all 603 randomisations from the primary analysis, which was consequently based on 638 randomisations. A sensitivity analysis, including all 961 randomisations over the entire study except for questionnaire completions of less than 20 seconds, found only minor differences from the primary analysis. CONCLUSION: Online studies offering incentives for participation are at risk of attempted fraud. Systematic monitoring and analysis can help detect such activity. Measures to protect study integrity include linking participant identifiers to study data, balancing study security and ease of participation, and safeguarding the allocation of participant incentives. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN41584028. Registration date is August 17, 2017.

A cluster randomised controlled trial, process and economic evaluation of quality improvement collaboratives aligned to a national audit to improve the care for people with diabetes (EQUIPD): study protocol.

BACKGROUND: People with type 1 diabetes and raised glucose levels are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. The UK National Institute for Health and Care Excellence (NICE) recommends continuous subcutaneous 'insulin pump' therapy for people with type 1 diabetes whose HbA1c is above 69 mmol/mol. Insulin pump use can improve quality of life, cut cardiovascular risk and increase treatment satisfaction. About 90,000 people in England and Wales meet NICE criteria for insulin pumps but do not use one. Insulin pump use also varies markedly by deprivation, ethnicity, sex and location. Increasing insulin pump use is a key improvement priority. Audit and feedback is a common but variably effective intervention. Limited capabilities of healthcare providers to mount effective responses to feedback from national audits, such as the National Diabetes Audit (NDA), undermines efforts to improve care. We have co-developed a theoretically and empirically informed quality improvement collaborative (QIC) to strengthen local responses to feedback with patients and carers, national audits and healthcare providers. We will evaluate whether the QIC improves the uptake of insulin pumps following NDA feedback. METHODS: We will undertake an efficient cluster randomised trial using routine data. The QIC will be delivered alongside the NDA to specialist diabetes teams in England and Wales. Our primary outcome will be the proportion of people with type 1 diabetes and an HbA1c above 69 mmol/mol who start and continue insulin pump use during the 18-month intervention period. Secondary outcomes will assess change in glucose control and duration of pump use. Subgroup analyses will explore impacts upon inequalities by ethnicity, sex, age and deprivation. A theory-informed process evaluation will explore diabetes specialist teams' engagement, implementation, fidelity and tailoring through observations, interviews, surveys and documentary analysis. An economic evaluation will micro-cost the QIC, estimate cost-effectiveness of NDA feedback with QIC and estimate the budget impact of NHS-wide QIC roll out. DISCUSSION: Our study responds to a need for more head-to-head trials of different ways of reinforcing feedback delivery. Our findings will have implications for other large-scale audit and feedback programmes. TRIAL REGISTRATION: ISRCTN82176651 Registered 18 October 2022.

What is the role of randomised trials in implementation science?

BACKGROUND: There is a consistent demand for implementation science to inform global efforts to close the gap between evidence and practice. Key evaluation questions for any given implementation strategy concern the assessment and understanding of effects. Randomised trials are generally accepted as offering the most trustworthy design for establishing effectiveness but may be underused in implementation science. MAIN BODY: There is a continuing debate about the primacy of the place of randomised trials in evaluating implementation strategies, especially given the evolution of more rigorous quasi-experimental designs. Further critiques of trials for implementation science highlight that they cannot provide 'real world' evidence, address urgent and important questions, explain complex interventions nor understand contextual influences. We respond to these critiques of trials and highlight opportunities to enhance their timeliness and relevance through innovative designs, embedding within large-scale improvement programmes and harnessing routine data. Our suggestions for optimising the conditions for randomised trials of implementation strategies include strengthening partnerships with policy-makers and clinical leaders to realise the long-term value of rigorous evaluation and accelerating ethical approvals and decluttering governance procedures for lower risk studies. CONCLUSION: Policy-makers and researchers should avoid prematurely discarding trial designs when evaluating implementation strategies and work to enhance the conditions for their conduct.

Improving data quality from routine clinical appointments-Development of a minimum dataset for traumatic dental injuries in children and adolescents.

BACKGROUND/AIMS: It is currently difficult to evaluate the success or not of treatment for dental injuries due to poor recording of diagnostic and treatment codes in clinical dentistry. A minimum dataset comprises a standardised minimum set of outcomes along with a specified outcome measurement instrument, to allow aggregated use of data from routine clinical care appointments. This study aimed to determine which outcomes should be included in a minimum dataset for traumatic dental injuries (TDI). MATERIALS AND METHODS: This is a three-stage sequential, mixed-methods study, using evidence-based best practice for dataset development. Normalisation process theory informed the development of the study protocols. In Stage 1, semi-structured interviews with patients and their parent or guardian were undertaken to identify outcomes of importance to patients. In Stage 2, an online Delphi survey was undertaken to identify outcomes of importance to clinicians. In Stage 3, a National Consensus Meeting was undertaken involving patient representatives, clinicians and other stakeholders, to agree which outcomes should be included in the minimum dataset. RESULTS: Stage 1: Eleven participants were recruited, five children and six parents. Two key themes emerged from the analysis-communication and aesthetics. In Stage 2, 34 dentists were recruited, and 32 completed both rounds of the survey (97% retention). Most outcomes were deemed by participants to be of 'critical importance', with three outcomes deemed 'important' and none to be 'of limited importance'. In Stage 3, 15 participants took part in the consensus meeting. Participants agreed that the dataset should comprise a list of clinician-important outcomes (pulp healing, periodontal healing, discolouration, tooth loss) and a list of patient-important outcomes (communication, aesthetics, pain, quality of life). CONCLUSION: A Minimum Dataset for TDI has been developed using a robust and transparent methodology.

GPs' willingness to prescribe aspirin for cancer preventive therapy in Lynch syndrome: a factorial randomised trial investigating factors influencing decisions.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) 2020 guidelines recommends aspirin for colorectal cancer prevention for people with Lynch syndrome. Strategies to change practice should be informed by understanding the factors influencing prescribing. AIM: To investigate the optimal type and level of information to communicate with GPs to increase willingness to prescribe aspirin. DESIGN AND SETTING: GPs in England and Wales (n = 672) were recruited to participate in an online survey with a 23 factorial design. GPs were randomised to one of eight vignettes describing a hypothetical patient with Lynch syndrome recommended to take aspirin by a clinical geneticist. METHOD: Across the vignettes, the presence or absence of three types of information was manipulated: 1) existence of NICE guidance; 2) results from the CAPP2 trial; 3) information comparing risks/benefits of aspirin. The main effects and all interactions on the primary (willingness to prescribe) and secondary outcomes (comfort discussing aspirin) were estimated. RESULTS: There were no statistically significant main effects or interactions of the three information components on willingness to prescribe aspirin or comfort discussing harms and benefits. In total, 80.4% (540/672) of GPs were willing to prescribe, with 19.7% (132/672) unwilling. GPs with prior awareness of aspirin for preventive therapy were more comfortable discussing the medication than those unaware (P = 0.031). CONCLUSION: It is unlikely that providing information on clinical guidance, trial results, and information comparing benefits and harms will increase aspirin prescribing for Lynch syndrome in primary care. Alternative multilevel strategies to support informed prescribing may be warranted.

Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial.

INTRODUCTION: Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component. METHODS AND ANALYSIS: The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 24-1 fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data. ETHICS AND DISSEMINATION: The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRTCN10487576.