Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale 'HENRY' (Health, Exercise, Nutrition for the Really Young): protocol for the HENRY III cluster randomised controlled trial.

INTRODUCTION: One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named 'centres') in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children. We aim to establish the effectiveness and cost-effectiveness of HENRY, including its potential role from a wider systems perspective. METHODS AND ANALYSIS: This is a multicentre, open-labelled, two-group, prospective, cluster randomised controlled trial, with cost-effectiveness analysis, systems-based process evaluation and internal pilot. Primary analysis will compare body mass index (BMI) z-score at 12 months in children (n=984) whose parents have attended HENRY to those who have not attended. Secondary outcomes include parent and staff BMI and waist circumference, parenting efficacy, feeding, eating habits, quality of life, resource use and medium term (3 years) BMI z-scores (child and siblings). 82 centres in ~14 local authority areas will be randomised (1:1) to receive HENRY or continue with standard practice. Intention-to-treat analysis will compare outcomes using mixed effects linear regression. Economic evaluation will estimate a within-trial calculation of cost-per unit change in BMI z-score and longer-term trajectories to determine lifelong cost savings (long-term outcomes). A systems process evaluation will explore whether (and how) implementation of HENRY impacts (and is impacted by) the early years obesity system. An established parent advisory group will support delivery and dissemination. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of York, Health Sciences' Research Governance Committee (HSRGC/2022/537/E). Dissemination includes policy reports, community resources, social media and academic outputs. TRIAL REGISTRATION NUMBER: ISRCTN16529380.

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.

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 randomised fractional factorial screening experiment to predict effective features of audit and feedback.

BACKGROUND: Audit and feedback aims to improve patient care by comparing healthcare performance against explicit standards. It is used to monitor and improve patient care, including through National Clinical Audit (NCA) programmes in the UK. Variability in effectiveness of audit and feedback is attributed to intervention design; separate randomised trials to address multiple questions about how to optimise effectiveness would be inefficient. We evaluated different feedback modifications to identify leading candidates for further "real-world" evaluation. METHODS: Using an online fractional factorial screening experiment, we randomised recipients of feedback from five UK NCAs to different combinations of six feedback modifications applied within an audit report excerpt: use effective comparators, provide multimodal feedback, recommend specific actions, provide optional detail, incorporate the patient voice, and minimise cognitive load. Outcomes, assessed immediately after exposure to the online modifications, included intention to enact audit standards (primary outcome, ranked on a scale of -3 to +3, tailored to the NCA), comprehension, user experience, and engagement. RESULTS: We randomised 1241 participants (clinicians, managers, and audit staff) between April and October 2019. Inappropriate repeated participant completion occurred; we conservatively excluded participant entries during the relevant period, leaving a primary analysis population of 638 (51.4%) participants. None of the six feedback modifications had an independent effect on intention across the five NCAs. We observed both synergistic and antagonistic effects across outcomes when modifications were combined; the specific NCA and whether recipients had a clinical role had dominant influences on outcome, and there was an antagonistic interaction between multimodal feedback and optional detail. Among clinical participants, predicted intention ranged from 1.22 (95% confidence interval 0.72, 1.72) for the least effective combination in which multimodal feedback, optional detail, and reduced cognitive load were applied within the audit report, up to 2.40 (95% CI 1.88, 2.93) for the most effective combination including multimodal feedback, specific actions, patient voice, and reduced cognitive load. CONCLUSION: Potentially important synergistic and antagonistic effects were identified across combinations of feedback modifications, audit programmes, and recipients, suggesting that feedback designers must explicitly consider how different features of feedback may interact to achieve (or undermine) the desired effects. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN41584028.

Explaining variable effects of an adaptable implementation package to promote evidence-based practice in primary care: a longitudinal process evaluation.

BACKGROUND: Implementing evidence-based recommendations is challenging in UK primary care, especially given system pressures and multiple guideline recommendations competing for attention. Implementation packages that can be adapted and hence applied to target multiple guideline recommendations could offer efficiencies for recommendations with common barriers to achievement. We developed and evaluated a package of evidence-based interventions (audit and feedback, educational outreach and reminders) incorporating behaviour change techniques to target common barriers, in two pragmatic trials for four "high impact" indicators: risky prescribing; diabetes control; blood pressure control; and anticoagulation in atrial fibrillation. We observed a significant, cost-effective reduction in risky prescribing but there was insufficient evidence of effect on the other outcomes. We explored the impact of the implementation package on both social processes (Normalisation Process Theory; NPT) and hypothesised determinants of behaviour (Theoretical Domains Framework; TDF). METHODS: We conducted a prospective multi-method process evaluation. Observational, administrative and interview data collection and analyses in eight primary care practices were guided by NPT and TDF. Survey data from trial and process evaluation practices explored fidelity. RESULTS: We observed three main patterns of variation in how practices responded to the implementation package. First, in integration and achievement, the package "worked" when it was considered distinctive and feasible. Timely feedback directed at specific behaviours enabled continuous goal setting, action and review, which reinforced motivation and collective action. Second, impacts on team-based determinants were limited, particularly when the complexity of clinical actions impeded progress. Third, there were delivery delays and unintended consequences. Delays in scheduling outreach further reduced ownership and time for improvement. Repeated stagnant or declining feedback that did not reflect effort undermined engagement. CONCLUSIONS: Variable integration within practice routines and organisation of care, variable impacts on behavioural determinants, and delays in delivery and unintended consequences help explain the partial success of an adaptable package in primary care.

Embedded trials within national clinical audit programmes: A qualitative interview study of enablers and barriers.

BACKGROUND: Audit and feedback entails systematic documentation of clinical performance based on explicit criteria or standards which is then fed back to professionals in a structured manner. There are potential significant returns on investment from partnerships between existing clinical audit programmes in coordinated programmes of research to test ways of improving the effect of their feedback to drive greater improvements in health care delivery and population outcomes. We explored barriers to and enablers of embedding audit and feedback trials within clinical audit programmes. METHODS: We purposively recruited participants with varied experience in embedded trials in audit programmes. We conducted qualitative semi-structured interviews, guided by behavioural theory, with researchers, clinical audit programme staff and health care professionals. Recorded interviews were transcribed, and data coded and thematically analysed. RESULTS: We interviewed 31 participants (9 feedback researchers, 14 audit staff and 8 healthcare professionals, many having dual roles). We identified barriers and enablers for all 14 theoretical domains but no relationship between domains and participant role. We identified four optimal conditions for sustainable collaboration from the perspectives of stakeholders: resources, that is, recognition that audit programmes need to create capacity to participate in research, and research must be adapted to fit within each programme's constraints; logistics, namely, that partnerships need to address data sharing and audit quality, while securing research funding to ensure operational success; leadership, that is, enthusiastic and engaged audit programme leaders must motivate their team and engage local stakeholders; and relationships, meaning that trust between researchers and audit programmes must be established over time by identifying shared priorities and meeting each partner's needs. CONCLUSION: Successfully embedding research within clinical audit programmes is likely to require compromise, logistical expertise, leadership and trusting relationships to overcome perceived risks and fully realise benefits.

The effects of an evidence- and theory-informed feedback intervention on opioid prescribing for non-cancer pain in primary care: A controlled interrupted time series analysis.

BACKGROUND: The rise in opioid prescribing in primary care represents a significant international public health challenge, associated with increased psychosocial problems, hospitalisations, and mortality. We evaluated the effects of a comparative feedback intervention with persuasive messaging and action planning on opioid prescribing in primary care. METHODS AND FINDINGS: A quasi-experimental controlled interrupted time series analysis used anonymised, aggregated practice data from electronic health records and prescribing data from publicly available sources. The study included 316 intervention and 130 control primary care practices in the Yorkshire and Humber region, UK, serving 2.2 million and 1 million residents, respectively. We observed the number of adult patients prescribed opioid medication by practice between July 2013 and December 2017. We excluded adults with coded cancer or drug dependency. The intervention, the Campaign to Reduce Opioid Prescribing (CROP), entailed bimonthly, comparative, and practice-individualised feedback reports to practices, with persuasive messaging and suggested actions over 1 year. Outcomes comprised the number of adults per 1,000 adults per month prescribed any opioid (main outcome), prescribed strong opioids, prescribed opioids in high-risk groups, prescribed other analgesics, and referred to musculoskeletal services. The number of adults prescribed any opioid rose pre-intervention in both intervention and control practices, by 0.18 (95% CI 0.11, 0.25) and 0.36 (95% CI 0.27, 0.46) per 1,000 adults per month, respectively. During the intervention period, prescribing per 1,000 adults fell in intervention practices (change -0.11; 95% CI -0.30, -0.08) and continued rising in control practices (change 0.54; 95% CI 0.29, 0.78), with a difference of -0.65 per 1,000 patients (95% CI -0.96, -0.34), corresponding to 15,000 fewer patients prescribed opioids. These trends continued post-intervention, although at slower rates. Prescribing of strong opioids, total opioid prescriptions, and prescribing in high-risk patient groups also generally fell. Prescribing of other analgesics fell whilst musculoskeletal referrals did not rise. Effects were attenuated after feedback ceased. Study limitations include being limited to 1 region in the UK, possible coding errors in routine data, being unable to fully account for concurrent interventions, and uncertainties over how general practices actually used the feedback reports and whether reductions in prescribing were always clinically appropriate. CONCLUSIONS: Repeated comparative feedback offers a promising and relatively efficient population-level approach to reduce opioid prescribing in primary care, including prescribing of strong opioids and prescribing in high-risk patient groups. Such feedback may also prompt clinicians to reconsider prescribing other medicines associated with chronic pain, without causing a rise in referrals to musculoskeletal clinics. Feedback may need to be sustained for maximum effect.

General practice responses to opioid prescribing feedback: a qualitative process evaluation.

BACKGROUND: The rise in opioid prescribing in primary care represents a significant public health challenge, associated with increased psychosocial problems, hospitalisations, and mortality. An evidence-based bimonthly feedback intervention to reduce opioid prescribing was developed and implemented, targeting 316 general practices in West Yorkshire over 1 year. AIM: To understand how general practice staff received and responded to the feedback intervention. DESIGN AND SETTING: Qualitative process evaluation involving semi-structured interviews, guided by Normalisation Process Theory (NPT), of primary care healthcare professionals targeted by feedback. METHOD: Participants were purposively recruited according to baseline opioid prescribing levels and degree of change following feedback. Interview data were coded to NPT constructs, and thematically analysed. RESULTS: Interviews were conducted with 21 staff from 20 practices. Reducing opioid prescribing was recognised as a priority. While high achievers had clear structures for quality improvement, feedback encouraged some less structured practices to embed changes. The non-prescriptive nature of the feedback reports allowed practices to develop strategies consistent with their own ways of working and existing resources. Practice concerns were allayed by the credibility of the reports and positive experiences of reducing opioid prescribing. The scale, frequency, and duration of feedback may have ensured a good overall level of practice population reach. CONCLUSION: The intervention engaged general practice staff in change by targeting an issue of emerging concern, and allowing adaption to different ways of working. Practice efforts to reduce opioid prescribing were reinforced by regular feedback, credible comparative data showing progress, and shared experiences of patient benefit.

Testing the feasibility of a sustainable preschool obesity prevention approach: a mixed-methods service evaluation of a volunteer-led HENRY programme.

BACKGROUND: Over the last 10 years HENRY has been working to reduce and prevent child obesity by training health and early years professionals to deliver its evidence-based programme to parents. The aim and unique contribution of this study was to evaluate whether training volunteers to deliver this programme on a one-to-one basis was feasible. METHODS: Mixed-methods service evaluation with parent-reported pre- and post-programme outcomes and focus groups conducted with parents and volunteer facilitators. The programme consisted of 8 one-to-one sessions delivered weekly by volunteers (n = 18) to build food and activity-related knowledge, skills, and understanding, and improve parenting efficacy, and parent and child eating and physical activity. Programmes took place at parent's (n = 69) home or local community venues in four London boroughs, United Kingdom. Parent-reported parenting efficacy, emotional wellbeing, eating, and physical activity data were captured, alongside parent ratings of the programme and volunteer ratings of the training. Parent and volunteer focus groups explored involvement, expectations, and experiences of the programme, training and delivery, feedback, and impact. RESULTS: Parents were mostly female, had varied ethnic backgrounds, and were often not working but well educated. There were statistically significant improvements of a medium-to-large size in parent and child emotional wellbeing, parenting efficacy, fruit and vegetable consumption, family eating and food purchasing behaviours. Parent ratings of the programme were positive and qualitative data highlighted the holistic nature of the programme, which focused on more than just food, and the relationships with volunteers as key facets. Volunteers were also mostly female, had varied ethnic backgrounds, and were often well educated, but more likely to be employed than parents. Volunteers rated the training and delivery as useful in enabling them to deliver the programme confidently and for their own wellbeing. Despite finding some sessions challenging emotionally, volunteers reported positive family lifestyle improvements by parents and children and that the experience would be useful for future employment. CONCLUSIONS: It is feasible to recruit and train volunteers to deliver a structured preschool obesity prevention programme, which parents considered acceptable and enjoyable, with preliminary reports of parent and child benefits.

An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation.

BACKGROUND: In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. METHODS AND FINDINGS: We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. CONCLUSIONS: In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. TRIAL REGISTRATION: The study is registered with the ISRCTN registry (ISRCTN91989345).

What are medical students' attitudes to clinical risk-scoring tools? An exploratory study.

Background: Clinical risk-scoring tools are increasingly recommended for use in general practice. Yet adoption of the tools has been variable and often low. Reasons for this have been explored, but medical students' perspectives have not previously been sought.Aim: To explore medical students' attitudes towards clinical risk-scoring tools.Methods: Qualitative, semi-structured interviews were conducted with eight medical students. Interviews were recorded, transcribed and analysed thematically.Results: Participants had a good understanding of the use of risk-scoring tools. They would trust them to enable evidence-based practice provided they are easy to use, not time-consuming and their results can help direct management. They were considered useful tools, especially for students and junior doctors. However, many believed the tools hold less value for experienced doctors. Their attitudes seem to have developed from discussions with clinicians, observation on placement, teaching received and exam content.Conclusion: This research recommends that implementation of risk-scoring tools will be increased if they are easier to use and if the belief that they hold less value for experienced doctors is challenged. The role of targeted teaching in changing these perceptions should be explored further, both for students and clinicians, who act as role models.

The impact of HENRY on parenting and family lifestyle: Exploratory analysis of the mechanisms for change.

BACKGROUND: Childhood obesity is a major public health concern. In the United Kingdom, a quarter of children are overweight or obese at age 5 years. Overweight and obese children are more likely to develop serious health issues such as diabetes later in life. Consequently, there is an urgent need for effective, early obesity prevention and intervention. This study investigated the impact of an 8-week child obesity intervention-HENRY (Health Exercise Nutrition for the Really Young)-designed to help parents with preschool children develop the skills and knowledge needed to improve family lifestyle and well-being. We were particularly interested in exploring the potential mechanisms by which HENRY may have a positive impact. METHOD: Focus groups (n = 7, total participants = 39) were completed with mothers attending the HENRY programme at one of seven locations across England. They took place within 2 weeks of programme completion. Follow-up telephone interviews were completed with a subsample of participants (n = 10) between 17 and 21 weeks later. RESULTS: Parents consistently reported enhanced self-efficacy in terms of improved confidence in their ability to encourage healthier behaviours such as eating fruit and vegetables and increasing physical activity, and improvements to family health behaviours. Many changes were reportedly sustained at follow-up. Data provided insights into the potential mechanisms that created the conditions for the positive changes. Participants described the importance of mutual support, being listened to by facilitators, and encouragement to identify their own ideas. Their comments indicated the success of a solution-focused, strength-based, partnership approach to supporting family lifestyle change. CONCLUSION: The results of this study contribute to the body of evidence suggesting that HENRY may have a positive impact on parenting and family lifestyle behaviour. Although data were collected in 2011, the findings contribute to an understanding of the components of effective obesity prevention in young children.

Leading Healthy Lives: Lifestyle Medicine for Medical Students.

Background. Doctors have a special role in helping patients make lifestyle changes, and they are more credible and effective if they are role models. Yet few medical schools have incorporated lifestyle medicine into their curricula. We ascertained the influence of a lifestyle medicine curriculum during the first year of medical school. Methods. The curriculum, involving 140 students, consisted of one intensive day at medical school entry and 16 hours of teaching 8 months later. It addressed students' own lifestyle choices and topics related to lifestyle medicine. A survey was delivered at the beginning and end of the academic year. Results. A total of 114 students completed the first survey and 64 the second. They rated the course highly for personal and professional value. At baseline, students exhibited lifestyle behaviors typical for young adults and showed an appreciation of the physician's role in lifestyle change. However, over time they showed a significant reduction in quality of lifestyle, with increased stress, weight gain, and fast food consumption and less exercise. Conclusions. Although lifestyle medicine knowledge is valued by medical students, a 24-hour intensive lifestyle medicine curriculum delivered over 3 days appears to be ineffective in preventing worsening lifestyle behaviors over the course of the year. This is especially concerning as physicians are unlikely to provide effective guidance if they cannot sustain healthy behaviors themselves.

Role of patient and public involvement in implementation research: a consensus study.

BACKGROUND: Patient and public involvement (PPI) is often an essential requirement for research funding. Distinctions can be drawn between clinical research, which generally focuses on patients, and implementation research, which generally focuses on health professional behaviour. There is uncertainty about the role of PPI in this latter field. We explored and defined the roles of PPI in implementation research to inform relevant good practice guidance. METHODS: We used a structured consensus process using a convenience sample panel of nine experienced PPI and two researcher members. We drew on available literature to identify 21 PPI research roles. The panel rated their agreement with roles independently online in relation to both implementation and clinical research. Disagreements were discussed at a face-to-face meeting prior to a second online rating of all roles. Median scores were calculated and a final meeting held to review findings and consider recommendations. RESULTS: Ten panellists completed the consensus process. For clinical research, there was strong support and consensus for the role of PPI throughout most of the research process. For implementation research, there were eight roles with consensus and strong support, seven roles with consensus but weaker support and six roles with no consensus. There were more disagreements relating to PPI roles in implementation research compared with clinical research. PPI was rated as contributing less to the design and management of implementation research than for clinical research. CONCLUSIONS: The roles of PPI need to be tailored according to the nature of research to ensure authentic and appropriate involvement. We provide a framework to guide the planning, conduct and reporting of PPI in implementation research, and encourage further research to evaluate its use.

To what extent can behaviour change techniques be identified within an adaptable implementation package for primary care? A prospective directed content analysis.

BACKGROUND: Interpreting evaluations of complex interventions can be difficult without sufficient description of key intervention content. We aimed to develop an implementation package for primary care which could be delivered using typically available resources and could be adapted to target determinants of behaviour for each of four quality indicators: diabetes control, blood pressure control, anticoagulation for atrial fibrillation and risky prescribing. We describe the development and prospective verification of behaviour change techniques (BCTs) embedded within the adaptable implementation packages. METHODS: We used an over-lapping multi-staged process. We identified evidence-based, candidate delivery mechanisms-mainly audit and feedback, educational outreach and computerised prompts and reminders. We drew upon interviews with primary care professionals using the Theoretical Domains Framework to explore likely determinants of adherence to quality indicators. We linked determinants to candidate BCTs. With input from stakeholder panels, we prioritised likely determinants and intervention content prior to piloting the implementation packages. Our content analysis assessed the extent to which embedded BCTs could be identified within the packages and compared them across the delivery mechanisms and four quality indicators. RESULTS: Each implementation package included at least 27 out of 30 potentially applicable BCTs representing 15 of 16 BCT categories. Whilst 23 BCTs were shared across all four implementation packages (e.g. BCTs relating to feedback and comparing behaviour), some BCTs were unique to certain delivery mechanisms (e.g. 'graded tasks' and 'problem solving' for educational outreach). BCTs addressing the determinants 'environmental context' and 'social and professional roles' (e.g. 'restructuring the social and 'physical environment' and 'adding objects to the environment') were indicator specific. We found it challenging to operationalise BCTs targeting 'environmental context', 'social influences' and 'social and professional roles' within our chosen delivery mechanisms. CONCLUSION: We have demonstrated a transparent process for selecting, operationalising and verifying the BCT content in implementation packages adapted to target four quality indicators in primary care. There was considerable overlap in BCTs identified across the four indicators suggesting core BCTs can be embedded and verified within delivery mechanisms commonly available to primary care. Whilst feedback reports can include a wide range of BCTs, computerised prompts can deliver BCTs at the time of decision making, and educational outreach can allow for flexibility and individual tailoring in delivery.

Variations in achievement of evidence-based, high-impact quality indicators in general practice: An observational study.

BACKGROUND: There are widely recognised variations in the delivery and outcomes of healthcare but an incomplete understanding of their causes. There is a growing interest in using routinely collected 'big data' in the evaluation of healthcare. We developed a set of evidence-based 'high impact' quality indicators (QIs) for primary care and examined variations in achievement of these indicators using routinely collected data in the United Kingdom (UK). METHODS: Cross-sectional analysis of routinely collected, electronic primary care data from a sample of general practices in West Yorkshire, UK (n = 89). The QIs covered aspects of care (including processes and intermediate clinical outcomes) in relation to diabetes, hypertension, atrial fibrillation, myocardial infarction, chronic kidney disease (CKD) and 'risky' prescribing combinations. Regression models explored the impact of practice and patient characteristics. Clustering within practice was accounted for by including a random intercept for practice. RESULTS: Median practice achievement of the QIs ranged from 43.2% (diabetes control) to 72.2% (blood pressure control in CKD). Considerable between-practice variation existed for all indicators: the difference between the highest and lowest performing practices was 26.3 percentage points for risky prescribing and 100 percentage points for anticoagulation in atrial fibrillation. Odds ratios associated with the random effects for practices emphasised this; there was a greater than ten-fold difference in the likelihood of achieving the hypertension indicator between the lowest and highest performing practices. Patient characteristics, in particular age, gender and comorbidity, were consistently but modestly associated with indicator achievement. Statistically significant practice characteristics were identified less frequently in adjusted models. CONCLUSIONS: Despite various policy and improvement initiatives, there are enduring inappropriate variations in the delivery of evidence-based care. Much of this variation is not explained by routinely collected patient or practice variables, and is likely to be attributable to differences in clinical and organisational behaviour.

Using the Theoretical Domains Framework (TDF) to understand adherence to multiple evidence-based indicators in primary care: a qualitative study.

BACKGROUND: There are recognised gaps between evidence and practice in general practice, a setting posing particular implementation challenges. We earlier screened clinical guideline recommendations to derive a set of 'high-impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. Here, we explore health professionals' perceived determinants of adherence to these indicators, examining the degree to which determinants were indicator-specific or potentially generalisable across indicators. METHODS: We interviewed 60 general practitioners, practice nurses and practice managers in West Yorkshire, the UK, about adherence to four indicators: avoidance of risky prescribing; treatment targets in type 2 diabetes; blood pressure targets in treated hypertension; and anticoagulation in atrial fibrillation. Interview questions drew upon the Theoretical Domains Framework (TDF). Data were analysed using framework analysis. RESULTS: Professional role and identity and environmental context and resources featured prominently across all indicators whilst the importance of other domains, for example, beliefs about consequences, social influences and knowledge varied across indicators. We identified five meta-themes representing more general organisational and contextual factors common to all indicators. CONCLUSIONS: The TDF helped elicit a wide range of reported determinants of adherence to 'high-impact' indicators in primary care. It was more difficult to pinpoint which determinants, if targeted by an implementation strategy, would maximise change. The meta-themes broadly underline the need to align the design of interventions targeting general practices with higher level supports and broader contextual considerations. However, our findings suggest that it is feasible to develop interventions to promote the uptake of different evidence-based indicators which share common features whilst also including content-specific adaptations.

Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.

BACKGROUND: There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive a set of 'high impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice. METHODS/DESIGN: The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an 'opt-out' recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data extracted 1 year after randomisation. Economic modelling will estimate intervention cost-effectiveness. A process evaluation involving eight non-trial practices will examine intervention delivery, mechanisms of action and unintended consequences. DISCUSSION: ASPIRE will provide 'real-world' evidence about the effects, cost-effectiveness and delivery of adapted intervention packages targeting high impact recommendations. By implementing our adaptable intervention package across four distinct clinical topics, and using 'opt-out' recruitment, our findings will provide evidence of wider generalisability. TRIAL REGISTRATION: ISRCTN91989345.

Optimizing primary care research participation: a comparison of three recruitment methods in data-sharing studies.

BACKGROUND: Recruitment of representative samples in primary care research is essential to ensure high-quality, generalizable results. This is particularly important for research using routinely recorded patient data to examine the delivery of care. Yet little is known about how different recruitment strategies influence the characteristics of the practices included in research. OBJECTIVE: We describe three approaches for recruiting practices to data-sharing studies, examining differences in recruitment levels and practice representativeness. METHODS: We examined three studies that included varying populations of practices from West Yorkshire, UK. All used anonymized patient data to explore aspects of clinical practice. Recruitment strategies were 'opt-in', 'mixed opt-in and opt-out' and 'opt-out'. We compared aggregated practice data between recruited and not-recruited practices for practice list size, deprivation, chronic disease management, patient experience and rates of unplanned hospital admission. RESULTS: The opt-out strategy had the highest recruitment (80%), followed by mixed (70%) and opt-in (58%). Practices opting-in were larger (median 7153 versus 4722 patients, P = 0.03) than practices that declined to opt-in. Practices recruited by mixed approach were larger (median 7091 versus 5857 patients, P = 0.04) and had differences in the clinical quality measure (58.4% versus 53.9% of diabetic patients with HbA1c ≤ 59 mmol/mol, P < 0.01). We found no differences between practices recruited and not recruited using the opt-out strategy for any demographic or quality of care measures. CONCLUSION: Opt-out recruitment appears to be a relatively efficient approach to ensuring participation of typical general practices. Researchers should, with appropriate ethical safeguards, consider opt-out recruitment of practices for studies involving anonymized patient data sharing.

Developing 'high impact' guideline-based quality indicators for UK primary care: a multi-stage consensus process.

BACKGROUND: Quality indicators (QIs) are an important tool for improving clinical practice and are increasingly being developed from evidence-based guideline recommendations. We aimed to identify, select and apply guideline recommendations to develop a set of QIs to measure the implementation of evidence-based practice using routinely recorded clinical data in United Kingdom (UK) primary care. METHODS: We reviewed existing national clinical guidelines and QIs and used a four-stage consensus development process to derive a set of 'high impact' QIs relevant to primary care based upon explicit prioritisation criteria. We then field tested the QIs using remotely extracted, anonymised patient records from 89 randomly sampled primary care practices in the Yorkshire region of England. RESULTS: Out of 2365 recommendations and QIs originally reviewed, we derived a set of 18 QIs (5 single, 13 composites - comprising 2-9 individual recommendations) for field testing. QIs predominantly addressed chronic disease management, in particular diabetes, cardiovascular and renal disease, and included both processes and outcomes of care. Field testing proved to be critical for further refinement and final selection. CONCLUSIONS: We have demonstrated a rigorous and transparent methodology to develop a set of high impact, evidence-based QIs for primary care from clinical guideline recommendations. While the development process was successful in developing a limited set of QIs, it remains challenging to derive robust new QIs from clinical guidelines in the absence of established systems for routine, structured recording of clinical care.