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.

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).

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.

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.

Cancer patients' needs assessment in primary care: study protocol for a cluster randomised controlled trial (cRCT), economic evaluation and normalisation process theory evaluation of the needs assessment tool cancer (CANAssess).

INTRODUCTION: Unmet needs in patients with cancer and their carers are common but poorly identified and addressed. The Needs Assessment Tool-Cancer (NAT-C) is a structured consultation guide to identify and triage patient and carer unmet needs. The NAT-C is validated, but its effectiveness in reducing unmet patient and carer needs in primary care is unknown. METHODS AND ANALYSIS: Cluster randomised controlled trial with internal pilot and embedded process evaluation to test the clinical and cost effectiveness of the NAT-C in primary care for people with active cancer in reducing unmet patient and carer need, compared with usual care. We will recruit 1080 patients with active cancer (and carers if relevant) from 54 general practices in England.Participating practices will be randomised 1:1 to either deliver an NAT-guided clinical consultation plus usual care or to usual care alone. Consenting participants with active cancer and their carers (if nominated) will be asked to complete study questionnaires at baseline, 1 and 3 months for all, 6 months except for those recruited outside of the last 3 months of recruitment, and attend an NAT-C appointment if allocated to an intervention practice. An internal pilot will assess: site and participant recruitment, intervention uptake and follow-up rates. The primary outcome, the proportion of patients with an unmet need on the Supportive Care Needs Survey Short Form 34 at 3 months postregistration, will be analysed using a multilevel logistic regression. Mixed-methods process evaluation informed by Normalisation Process Theory will use quantitative survey and interview data from clinicians and key stakeholders in cancer care to develop an implementation strategy for nationwide rollout of the NAT-C if the intervention is cost-effective. ETHICS AND DISSEMINATION: Ethical approval from London-Surrey REC (20/LO/0312). Results will be peer-reviewed, published and made available to research participants. TRIAL REGISTRATION NUMBER: ISRCTN15497400.

Quality indicators and performance measures for prison healthcare: a scoping review.

BACKGROUND: Internationally, people in prison should receive a standard of healthcare provision equivalent to people living in the community. Yet efforts to assess the quality of healthcare through the use of quality indicators or performance measures have been much more widely reported in the community than in the prison setting. This review aims to provide an overview of research undertaken to develop quality indicators suitable for prison healthcare. METHODS: An international scoping review of articles published in English was conducted between 2004 and 2021. Searches of six electronic databases (MEDLINE, CINAHL, Scopus, Embase, PsycInfo and Criminal Justice Abstracts) were supplemented with journal searches, author searches and forwards and backwards citation tracking. RESULTS: Twelve articles were included in the review, all of which were from the United States. Quality indicator selection processes varied in rigour, and there was no evidence of patient involvement in consultation activities. Selected indicators predominantly measured healthcare processes rather than health outcomes or healthcare structure. Difficulties identified in developing performance measures for the prison setting included resource constraints, data system functionality, and the comparability of the prison population to the non-incarcerated population. CONCLUSIONS: Selecting performance measures for healthcare that are evidence-based, relevant to the population and feasible requires rigorous and transparent processes. Balanced sets of indicators for prison healthcare need to reflect prison population trends, be operable within data systems and be aligned with equivalence principles. More effort needs to be made to meaningfully engage people with lived experience in stakeholder consultations on prison healthcare quality. Monitoring healthcare structure, processes and outcomes in prison settings will provide evidence to improve care quality with the aim of reducing health inequalities experienced by people living in prison.

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).

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.

BACKGROUND: Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. METHODS/DESIGN: The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. DISCUSSION: This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot trial is planned to determine the practicality of undertaking a definitive trial to robustly evaluate the effectiveness and cost-effectiveness of the optimised intervention on childhood obesity prevention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02675699 . Registered on 4 February 2016.

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.

Implementation science: a reappraisal of our journal mission and scope.

The implementation of research findings into healthcare practice has become increasingly recognised as a major priority for researchers, service providers, research funders and policymakers over the past decade. Nine years after its establishment, Implementation Science, an international online open access journal, currently publishes over 150 articles each year. This is fewer than 30% of those submitted for publication. The majority of manuscript rejections occur at the point of initial editorial screening, frequently because we judge them to fall outside of journal scope. There are a number of common reasons as to why manuscripts are rejected on grounds of scope. Furthermore, as the field of implementation research has evolved and our journal submissions have risen, we have, out of necessity, had to become more selective in what we publish. We have also expanded our scope, particularly around patient-mediated and population health interventions, and will monitor the impact of such changes. We hope this editorial on our evolving priorities and common reasons for rejection without peer review will help authors to better judge the relevance of their papers to Implementation Science.

Does a local financial incentive scheme reduce inequalities in the delivery of clinical care in a socially deprived community? A longitudinal data analysis.

BACKGROUND: Socioeconomic deprivation is associated with inequalities in health care and outcomes. Despite concerns that the Quality and Outcomes Framework pay-for-performance scheme in the UK would exacerbate inequalities in primary care delivery, gaps closed over time. Local schemes were promoted as a means of improving clinical engagement by addressing local health priorities. We evaluated equity in achievement of target indicators and practice income for one local scheme. METHODS: We undertook a longitudinal survey over four years of routinely recorded clinical data for all 83 primary care practices. Sixteen indicators were developed that covered five local clinical and public health priorities: weight management; alcohol consumption; learning disabilities; osteoporosis; and chlamydia screening. Clinical indicators were logit transformed from a percentage achievement scale and modelled allowing for clustering of repeated measures within practices. This enabled our study of target achievements over time with respect to deprivation. Practice income was also explored. RESULTS: Higher practice deprivation was associated with poorer performance for five indicators: alcohol use registration (OR 0.97; 95 % confidence interval 0.96,0.99); recorded chlamydia test result (OR 0.97; 0.94,0.99); osteoporosis registration (OR 0.98; 0.97,0.99); registration of repeat prednisolone prescription (OR 0.98; 0.96,0.99); and prednisolone registration with record of dual energy X-ray absorptiometry (DEXA) scan/referral (OR 0.92; 0.86,0.97); practices in deprived areas performed better for one indicator (registration of osteoporotic fragility fracture (OR 1.26; 1.04,1.51). The deprivation-achievement gap widened for one indicator (registered females aged 65-74 with a fracture referred for a DEXA scan; OR 0.97; 0.95,0.99). Two other indicators indicated a similar trend over two years before being withdrawn (registration of fragility fracture and over-75 s with a fragility fracture assessed and treated for osteoporosis risk). For one indicator the deprivation-achievement gap reduced over time (repeat prednisolone prescription (OR 1.01; 1.01,1.01). Larger practices and those serving more affluent areas earned more income per patient than smaller practices and those serving more deprived areas (t = -3.99; p =0.0001). CONCLUSIONS: Any gaps in achievement between practices were modest but mostly sustained or widened over the duration of the scheme. Given that financial rewards may not reflect the amount of work undertaken by practices serving more deprived patients, future pay-for-performance schemes also need to address fairness of rewards in relation to workload.

The evaluation of a tailored intervention to improve the management of suspected viral encephalitis: protocol for a cluster randomised controlled trial.

BACKGROUND: Viral encephalitis is a devastating condition for which delayed treatment is associated with increased morbidity and mortality. Clinical audits indicate substantial scope for improved detection and treatment. Improvement strategies should ideally be tailored according to identified needs and barriers to change. The aim of the study is to evaluate the effectiveness and cost-effectiveness of a tailored intervention to improve the secondary care management of suspected encephalitis. METHODS/DESIGN: The study is a two-arm cluster randomised controlled trial with allocation by postgraduate deanery. Participants were identified from 24 hospitals nested within 12 postgraduate deaneries in the United Kingdom (UK). We developed a multifaceted intervention package including core and flexible components with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. The primary outcome will be a composite of the proportion of patients with suspected encephalitis receiving timely and appropriate diagnostic lumbar puncture within 12 h of hospital admission and aciclovir treatment within 6 h. We will gather outcome data pre-intervention and up to 12 months post-intervention from patient records. Statistical analysis at the cluster level will be blind to allocation. An economic evaluation will estimate intervention cost-effectiveness from the health service perspective. TRIAL REGISTRATION: Controlled Trials: ISRCTN06886935.

'Just another incentive scheme': a qualitative interview study of a local pay-for-performance scheme for primary care.

BACKGROUND: A range of policy initiatives have addressed inequalities in healthcare and health outcomes. Local pay-for-performance schemes for primary care have been advocated as means of enhancing clinical ownership of the quality agenda and better targeting local need compared with national schemes such as the UK Quality and Outcomes Framework (QOF). We investigated whether professionals' experience of a local scheme in one English National Health Service (NHS) former primary care trust (PCT) differed from that of the national QOF in relation to the goal of reducing inequalities. METHODS: We conducted retrospective semi-structured interviews with primary care professionals implementing the scheme and those involved in its development. We purposively sampled practices with varying levels of population socio-economic deprivation and achievement. Interviews explored perceptions of the scheme and indicators, likely mechanisms of influence on practice, perceived benefits and harms, and how future schemes could be improved. We used a framework approach to analysis. RESULTS: Thirty-eight professionals from 16 general practices and six professionals involved in developing local indicators participated. Our findings cover four themes: ownership, credibility of the indicators, influences on behaviour, and exacerbated tensions. We found little evidence that the scheme engendered any distinctive sense of ownership or experiences different from the national scheme. Although the indicators and their evidence base were seldom actively questioned, doubts were expressed about their focus on health promotion given that eventual benefits relied upon patient action and availability of local resources. Whilst practices serving more affluent populations reported status and patient benefit as motivators for participating in the scheme, those serving more deprived populations highlighted financial reward. The scheme exacerbated tensions between patient and professional consultation agendas, general practitioners benefitting directly from incentives and nurses who did much of the work, and practices serving more and less affluent populations which faced different challenges in achieving targets. CONCLUSIONS: The contentious nature of pay-for-performance was not necessarily reduced by local adaptation. Those developing future schemes should consider differential rewards and supportive resources for practices serving more deprived populations, and employing a wider range of levers to promote professional understanding and ownership of indicators.

The effects of financial incentives for case finding for depression in patients with diabetes and coronary heart disease: interrupted time series analysis.

OBJECTIVE: To evaluate the effects of Quality and Outcomes Framework (QOF) incentivised case finding for depression on diagnosis and treatment in targeted and non-targeted long-term conditions. DESIGN: Interrupted time series analysis. SETTING: General practices in Leeds, UK. PARTICIPANTS: 65 (58%) of 112 general practices shared data on 37,229 patients with diabetes and coronary heart disease targeted by case finding incentives, and 101,008 patients with four other long-term conditions not targeted (hypertension, epilepsy, chronic obstructive pulmonary disease and asthma). INTERVENTION: Incentivised case finding for depression using two standard screening questions. MAIN OUTCOME MEASURES: Clinical codes indicating new depression-related diagnoses and new prescriptions of antidepressants. We extracted routinely recorded data from February 2002 through April 2012. The number of new diagnoses and prescriptions for those on registers was modelled with a binomial regression, which provided the strength of associations between time periods and their rates. RESULTS: New diagnoses of depression increased from 21 to 94/100,000 per month in targeted patients between the periods 2002-2004 and 2007-2011 (OR 2.09; 1.92 to 2.27). The rate increased from 27 to 77/100,000 per month in non-targeted patients (OR 1.53; 1.46 to 1.62). The slopes in prescribing for both groups flattened to zero immediately after QOF was introduced but before incentivised case finding (p<0.01 for both). Antidepressant prescribing in targeted patients returned to the pre-QOF secular upward trend (Wald test for equivalence of slope, z=0.73, p=0.47); the slope was less steep for non-targeted patients (z=-4.14, p<0.01). CONCLUSIONS: Incentivised case finding increased new depression-related diagnoses. The establishment of QOF disrupted rising trends in new prescriptions of antidepressants, which resumed following the introduction of incentivised case finding. Prescribing trends are of concern given that they may include people with mild-to-moderate depression unlikely to respond to such treatment.

Incentivised case finding for depression in patients with chronic heart disease and diabetes in primary care: an ethnographic study.

OBJECTIVE: To examine the process of case finding for depression in people with diabetes and coronary heart disease within the context of a pay-for-performance scheme. DESIGN: Ethnographic study drawing on observations of practice routines and consultations, debriefing interviews with staff and patients and review of patient records. SETTING: General practices in Leeds, UK. PARTICIPANTS: 12 purposively sampled practices with a total of 119 staff; 63 consultation observations and 57 patient interviews. MAIN OUTCOME MEASURE: Audio recorded consultations and interviews with patients and healthcare professionals along with observation field notes were thematically analysed. We assessed outcomes of case finding from patient records. RESULTS: Case finding exacerbated the discordance between patient and professional agendas, the latter already dominated by the tightly structured and time-limited nature of chronic illness reviews. Professional beliefs and abilities affected how case finding was undertaken; there was uncertainty about how to ask the questions, particularly among nursing staff. Professionals were often wary of opening an emotional 'can of worms'. Subsequently, patient responses potentially suggesting emotional problems could be prematurely shut down by professionals. Patients did not understand why they were asked questions about depression. This sometimes led to defensive or even defiant answers to case finding. Follow-up of patients highlighted inconsistent systems and lines of communication for dealing with positive results on case finding. CONCLUSIONS: Case finding does not fit naturally within consultations; both professional and patient reactions somewhat subverted the process recommended by national guidance. Quality improvement strategies will need to take account of our results in two ways. First, despite their apparent simplicity, the case finding questions are not consultation-friendly and acceptable alternative ways to raise the issue of depression need to be supported. Second, case finding needs to operate within structured pathways which can be accommodated within available systems and resources.

Advancing the science of patient safety.

Despite a decade's worth of effort, patient safety has improved slowly, in part because of the limited evidence base for the development and widespread dissemination of successful patient safety practices. The Agency for Healthcare Research and Quality sponsored an international group of experts in patient safety and evaluation methods to develop criteria to improve the design, evaluation, and reporting of practice research in patient safety. This article reports the findings and recommendations of this group, which include greater use of theory and logic models, more detailed descriptions of interventions and their implementation, enhanced explanation of desired and unintended outcomes, and better description and measurement of context and of how context influences interventions. Using these criteria and measuring and reporting contexts will improve the science of patient safety.

How does context affect interventions to improve patient safety? An assessment of evidence from studies of five patient safety practices and proposals for research.

BACKGROUND: Logic and experience suggest that it is easier in some situations than in others to change behaviour and organisation to improve patient safety. Knowing which 'context factors' help and hinder implementation of different changes would help implementers, as well as managers, policy makers, regulators and purchasers of healthcare. It could help to judge the likely success of possible improvements, given the conditions that they have, and to decide which of these conditions could be modified to make implementation more effective. METHODS: The study presented in this paper examined research to discover any evidence reported about whether or how context factors influence the effectiveness of five patient safety interventions. RESULTS: The review found that, for these five diverse interventions, there was little strong evidence of the influence of different context factors. However, the research was not designed to investigate context influence. CONCLUSIONS: The paper suggests that significant gaps in research exist and makes proposals for future research better to inform decision-making.

Health research funding agencies' support and promotion of knowledge translation: an international study.

CONTEXT: The process of knowledge translation (KT) in health research depends on the activities of a wide range of actors, including health professionals, researchers, the public, policymakers, and research funders. Little is known, however, about health research funding agencies' support and promotion of KT. Our team asked thirty-three agencies from Australia, Canada, France, the Netherlands, Scandinavia, the United Kingdom, and the United States about their role in promoting the results of the research they fund. METHODS: Semistructured interviews were conducted with a sample of key informants from applied health funding agencies identified by the investigators. The interviews were supplemented with information from the agencies' websites. The final coding was derived from an iterative thematic analysis. FINDINGS: There was a lack of clarity between agencies as to what is meant by KT and how it is operationalized. Agencies also varied in their degree of engagement in this process. The agencies' abilities to create a pull for research findings; to engage in linkage and exchange between agencies, researchers, and decision makers; and to push results to various audiences differed as well. Finally, the evaluation of the effectiveness of KT strategies remains a methodological challenge. CONCLUSIONS: Funding agencies need to think about both their conceptual framework and their operational definition of KT, so that it is clear what is and what is not considered to be KT, and adjust their funding opportunities and activities accordingly. While we have cataloged the range of knowledge translation activities conducted across these agencies, little is known about their effectiveness and so a greater emphasis on evaluation is needed. It would appear that "best practice" for funding agencies is an elusive concept depending on the particular agency's size, context, mandate, financial considerations, and governance structure.