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BackgroundHigh-risk primary care prescribing is common and is known to vary considerably between practices, but the extent to which high-risk prescribing varies among individual general practitioners (GPs) is not known.ObjectivesTo create prescribing safety indicators usable in existing electronic clinical data and to examine (1) variation in high-risk prescribing between patients, GPs and practices including reliability of measurement and (2) changes over time in high-risk prescribing prevalence and variation between practices.DesignDescriptive analysis and multilevel logistic regression modelling of routine data.SettingUK general practice using routine electronic medical record data.Participants(1) For analysis of variation and reliability, 398 GPs and 26,539 patients in 38 Scottish practices. (2) For analysis of change in high-risk prescribing, ≈ 300,000 patients particularly vulnerable to adverse drug effects registered with 190 Scottish practices.Main outcome measuresFor the analysis of variation between practices and between GPs, five indicators of high-risk non-steroidal anti-inflammatory drug (NSAID) prescribing. For the analysis of change in high-risk prescribing, 19 previously validated indicators.ResultsMeasurement of high-risk prescribing at GP level was feasible only for newly initiated drugs and for drugs similar to NSAIDs which are usually initiated by GPs. There was moderate variation between practices in total high-risk NSAID prescribing [intraclass correlation coefficient (ICC) 0.034], but this indicator was highly reliable (> 0.8 for all practices) at distinguishing between practices because of the large number of patients being measured. There was moderate variation in initiation of high-risk NSAID prescribing between practices (ICC 0.055) and larger variation between GPs (ICC 0.166), but measurement did not reliably distinguish between practices and had reliability > 0.7 for only half of the GPs in the study. Between quarter (Q)2 2004 and Q1 2009, the percentage of patients exposed to high-risk prescribing measured by 17 indicators that could be examined over the whole period fell from 8.5% to 5.2%, which was largely driven by reductions in high-risk NSAID and antiplatelet use. Variation between practices increased for five indicators and decreased for five, with no relationship between change in the rate of high-risk prescribing and change in variation between practices.ConclusionsHigh-risk prescribing is common and varies moderately between practices. High-risk prescribing at GP level cannot be easily measured routinely because of the difficulties in accurately identifying which GP actually prescribed the drug and because drug initiation is often a shared responsibility with specialists. For NSAID initiation, there was approximately three times greater variation between GPs than between practices. Most GPs with above average high-risk prescribing worked in practices which were not themselves above average. The observed reductions in high-risk prescribing between 2004 and 2009 were largely driven by falls in NSAID and antiplatelet prescribing, and there was no relationship between change in rate and change in variation between practices. These results are consistent with improvement interventions in all practices being more appropriate than interventions targeted on practices or GPs with higher than average high-risk prescribing. There is a need for research to understand why high-risk prescribing varies and to design and evaluate interventions to reduce it.FundingFunding for this study was provided by the Health Services and Delivery Research programme of the National Institute for Health Research.

ObjectivesHigh-risk prescribing in primary care is common and causes considerable harm, with for example, ~6% of emergency hospital admissions caused by adverse drug effects. Our aim is to rigorously develop and evaluate complex interventions to improve primary care prescribing safety using routine clinical and administrative data. ApproachCo-design of interventions by joint academic and clinical teams with implementation embedded in NHS Scotland information and contractual systems. Routine data from general practice electronic medical records (EMRs) or from the NHS Scotland prescribing payment system are used to both underpin the interventions and allow evaluation. Two cluster-randomised trials in 295 general practices have been completed (EFIPPS and DQIP), and two trials in 298 practices are in progress (EPIPP and POEMS), involving ~55% of Scottish general practices in total. The completed EFIPPS trial was a three-arm cluster randomised trial of a routine data feedback intervention +/- a theory-informed behaviour intervention involving 262 (~95%) of practices in three health boards. The completed DQIP trial was a stepped-wedge cluster randomised trial in 33 (50%) practices in one Health Board, the intervention comprising a web-based informatics tool to identify patients needing review from practice EMRs and to facilitate and structure review, an educational outreach visit, and financial incentives to review patients. EPIPP is evaluating a more complex feedback intervention, where both arms receive an active intervention on a different topic, involving all 242 practices in one Health Board. POEMS is evaluating an ‘enhanced medication summary’ to support contractually required-polypharmacy reviews in older people taking 10 or more regular medications, involving all 56 practices in one Health Board. ResultsThe simpler EFIPPS intervention reduced high-risk prescribing by 12% by 15 months after feedback started. We are currently examining what happened in the year after feedback ceased. The more intensive DQIP intervention reduced high-risk prescribing by 37% at 12 months. This effect was sustained in the 12 months after the financial incentives ceased because the intervention reduced new high-risk prescribing. The DQIP intervention also led to large reductions in related emergency hospital admissions with gastrointestinal bleeding, acute kidney injury and heart failure. ConclusionWe have shown that informatics-based interventions using routine data and co-designed with clinicians and managers are effective in improving primary care prescribing safety. The presentation will describe our approach to intervention development and implementation, show examples of the interventions, and present outcomes and process evaluation data from the two completed trials.

BackgroundAs quality improvement (QI) programmes have become progressively larger scale, the risks of implementation having unintended consequences are increasingly recognised. More routine use of balancing measures to monitor unintended consequences has been proposed to evaluate overall effectiveness, but in practice published improvement interventions hardly ever report identification or measurement of consequences other than intended goals of improvement.MethodsWe conducted 15 semistructured interviews and two focus groups with 24 improvement experts to explore the current understanding of balancing measures in QI and inform a more balanced accounting of the overall impact of improvement interventions. Data were analysed iteratively using the framework approach.ResultsParticipants described the consequences of improvement in terms of desirability/undesirability and the extent to which they were expected/unexpected when planning improvement. Four types of consequences were defined: expected desirable consequences (goals); expected undesirable consequences (trade-offs); unexpected undesirable consequences (unpleasant surprises); and unexpected desirable consequences (pleasant surprises). Unexpected consequences were considered important but rarely measured in existing programmes, and an improvement pause to take stock after implementation would allow these to be more actively identified and managed. A balanced accounting of all consequences of improvement interventions can facilitate staff engagement and reduce resistance to change, but has to be offset against the cost of additional data collection.ConclusionImprovement measurement is usually focused on measuring intended goals, with minimal use of balancing measures which when used, typically monitor trade-offs expected before implementation. This paper proposes that improvers and leaders should seek a balanced accounting of all consequences of improvement across the life of an improvement programme, including deliberately pausing after implementation to identify and quantitatively or qualitatively evaluate any pleasant or unpleasant surprises.

Current international guidelines promote the use of stroke risk stratification tools to inform decision making about oral anticoagulant (OAC) use in atrial fibrillation (AF).To examine (a) differences between CHADS2 and CHA2DS2VASc in classifying stroke risk in a primary care population of AF patients; (b) patterns of use of antithrombotics by stroke risk; and (c) patient and practice characteristics associated with use of oral anticoagulants in patients with AF.Cross-sectional multilevel modelling study of all patients with AF and without rheumatic heart disease or valve replacement (n = 21 564) from 315 Scottish General Practices.(a) CHADS2 characterized 30.3% in the intermediate and 53.8% in the high-risk category, compared to CHA2DS2VASC only 9.7% intermediate and 85.1% high-risk. (b) Of included patients, 17.8% were currently not prescribed any antithrombotic and 43.3% were on OAC. OAC use was only weakly related to stroke risk. (c) Patients with paroxysmal AF and those with dementia and previous peptic ulcer (adjusted ORs 0.26, 0.25 and 0.79) were less likely to be prescribed OAC. OAC use varied over five-fold between practices after adjustment for patient case mix, with remote and non-training practices and those with high levels of high-risk prescribing being more likely to prescribe OAC.Evidence was found of both underuse and overuse of OAC in patients with AF. Promoting instruments for stroke risk assessment in AF is a plausible but untested strategy to improve decision making in AF, and its impact on OAC prescribing and patient outcomes should be evaluated in pragmatic trials.

This article provides a summary of main messages of the annual Steve Hudson memorial lecture presented by Tobias Dreischulte at the 42nd European Society of Clinical Pharmacy symposium in Prague in 2013. An exploration of what is meant by integrated pharmaceutical care, the design and pilot testing of a model for continuous quality improvement of medication use designed to facilitate care integration, and opportunities and challenges of implementing the model in practice are discussed.

Background Medication assessment tools (MATs) may be implemented in routine electronic data sources in order to identify patients with opportunities for optimisation of medication therapy management (MTM) and follow-up by a multi-disciplinary team. Objective (1) To demonstrate the use of a MAT for cardiovascular conditions (MAT(CVC)) as a means of profiling potential opportunities for MTM optimisation in primary care and (2) to assess the performance of MAT(CVC) in identifying actual opportunities for better care. Setting Members of a pharmacotherapy discussion group, i.e. two single-handed general practitioners (GPs), three GP partners, and community pharmacists (CPs) from each of two community pharmacies, in a rural part of the Netherlands. Methods MAT(CVC) comprises 21 medication assessment criteria, each of which is designed to detect a specific care issue and to check whether it is 'addressed' by provision of guideline recommended care or 'open' in the presence ('open explained') or absence ('open unexplained') of pre-specified explanations for guideline deviations. (1) Relevant data was extracted from linked GP and CP electronic records and MAT(CVC) assessment was conducted to profile the population of CVC patients registered with both, participating CPs and GPs, in terms of 'open unexplained' care issues. (2) A purposive sample of patients with 'open unexplained' care issues was reviewed by each patient's GP. Main outcome measures Number and proportion of 'open unexplained' care issues per MAT(CVC) criterion and per patient. The number of patients with MAT(CVC) detected 'open unexplained' care issues to be reviewed (NNR) in order to identify one that requires changes in MTM. Results In 1,876 target group patients, MAT(CVC) identified 6,915 care issues, of which 2,770 (40.1 %) were 'open unexplained'. At population level, ten MAT(CVC) criteria had particularly high potential for quality improvement. At patient level, 1,277 (68.1 %) target group patients had at least one 'open unexplained' care issue. For patients with four or more 'open unexplained' care issues, the NNR was 2 (95 % CI 2-2). Conclusion The study demonstrates potential ways of using MAT(CVC) as a key component of a collaborative MTM system. Strategies that promote documentation and sharing of explanations for deviating from guideline recommendations may enhance the utility of the approach.

BACKGROUND High-risk prescribing and preventable drug-related complications are common in primary care. We evaluated whether the rates of high-risk prescribing by primary care clinicians and the related clinical outcomes would be reduced by a complex intervention. METHODS In this cluster-randomized, stepped-wedge trial conducted in Tayside, Scotland, we randomly assigned participating primary care practices to various start dates for a 48-week intervention comprising professional education, informatics to facilitate review, and financial incentives for practices to review patients’ charts to assess appropriateness. The primary outcome was patient-level exposure to any of nine measures of high-risk prescribing of nonsteroidal antiinflammatory drugs (NSAIDs) or selected antiplatelet agents (e.g., NSAID prescription in a patient with chronic kidney disease or coprescription of an NSAID and an oral anticoagulant without gastroprotection). Prespecified secondary outcomes included the incidence of related hospital admissions. Analyses were performed according to the intention-to-treat principle, with the use of mixed-effect models to account for clustering in the data. RESULTS A total of 34 practices underwent randomization, 33 of which completed the study. Data were analyzed for 33,334 patients at risk at one or more points in the preintervention period and for 33,060 at risk at one or more points in the intervention period. Targeted high-risk prescribing was significantly reduced, from a rate of 3.7% (1102 of 29,537 patients at risk) immediately before the intervention to 2.2% (674 of 30,187) at the end of the intervention (adjusted odds ratio, 0.63; 95% confidence interval [CI], 0.57 to 0.68; P

Background: Incidence of acute kidney injury (AKI), requiring dialysis, is on the rise globally and is associated with high mortality and morbidity. Aim: This study is aimed at examining the incidence of AKI requiring renal replacement therapy (RRT) in the Tayside region of Scotland and the impact of RRT for AKI on morbidity, mortality and length of hospital stay. Methods: One hundred seventy eight patients (>18 years of age) who received acute RRT between January 1, 2012 and December 31, 2012 were retrospectively selected for inclusion in the longitudinal cohort study. Incidence rate was calculated. Length of hospital stay, likely cause of AKI, renal recovery and mortality data were collected for a follow-up period of 1 year or until death. Chi-square test was used to compare the morbidity and mortality data between subgroups. RRT-free survival and time-until-event (death or RRT) analysis was performed using Kaplan-Meier plots. Cox-regression was used to examine the relationship between age, sex, diabetes and chronic kidney disease (CKD) on survival. Results: Incidence of AKI requiring RRT was 430 per million population per year. Median length of hospital stay was 21 days. In-patient mortality was 36%, mortality at 90 days was 44% and at 1 year 54%. Median time from start of RRT until death or chronic RRT was 90 days (95% CI 14-166). One-year cumulative RRT-free survival was 26% in the ward, 36% in high dependency units and 48% in intensive care unit subgroups. Diabetes, gender and CKD at baseline did not affect RRT-free survival in the cohort being studied. A quarter of the cohort regained full renal function and 15% of survivors were on a chronic dialysis programme at 1 year. Conclusions: This study gives a comprehensive summary of renal outcomes and mortality after a single episode of AKI requiring RRT. The findings of the study confirm that dialysis-dependent AKI is associated with increased length of hospital stay, high mortality and loss of renal function long term, emphasizing the importance of recognition, classification and prevention of AKI.

To test a method to quantify adherence of medication use to clinical guideline recommendations in a primary care setting. (Abstracts from the ESCP 36th European Symposium on Clinical Pharmacy 'Implementing Clinical Pharmacy in Community and Hospital Settings: Sharing the Experience', Istanbul, Turkey 25-27 October 2007; published in 'Pharmacy World and Science': http://www.springerlink.com/content/b4u765154t051245/fulltext.pdf)

Aims To measure the prevalence of beta-blocker eye drop prescribing and respiratory effect of ocular beta-blocker administration in people with asthma. Methods We measured the prevalence of ocular beta-blocker prescribing in people with asthma and ocular hypertension, and performed a nested case–control study (NCCS) measuring risk of moderate exacerbations (rescue steroids in primary care) and severe exacerbations (asthma hospitalization) using linked data from the UK Clinical Practice Research Datalink. We then performed a systematic review and meta-analysis of clinical trials evaluating changes in lung function following ocular beta-blocker administration in people with asthma. Results From 2000 to 2012, the prevalence of non-selective and selective beta-blocker eye drop prescribing in people with asthma and ocular hypertension fell from 23.0% to 13.4% and from 10.5% to 0.9% respectively. In the NCCS, the relative incidence (IRR) of moderate exacerbations increased significantly with acute non-selective beta-blocker eye drop exposure (IRR 4.83, 95% CI 1.56–14.94) but not with chronic exposure. In the meta-analysis, acute non-selective beta-blocker eye drop exposure caused significant mean falls in FEV1 of −10.9% (95% CI −14.9 to −6.9), and falls in FEV1 of ≥20% affecting one in three. Corresponding values for selective beta-blockers in people sensitive to ocular non-selective beta-blockers was −6.3% (95% CI −11.7 to −0.8), and a non-significant increase in falls in FEV1 of ≥20%. Conclusion Non-selective beta-blocker eye drops significantly affect lung function and increase asthma morbidity but are still frequently prescribed to people with asthma and ocular hypertension despite safer agents being available.

Objectives Primary care high-risk prescribing causes significant harm, but it is unclear if it is largely driven by individuals (a ‘bad apple’ problem) or by practices having higher or lower risk prescribing cultures (a ‘spoiled barrel’ problem). The study aimed to examine the extent of variation in high-risk prescribing between individual prescribers and between the practices they work in. Design, setting and participants Multilevel logistic regression modelling of routine cross-sectional data from 38 Scottish general practices for 181 010 encounters between 398 general practitioners (GPs) and 26 539 patients particularly vulnerable to adverse drug events (ADEs) of non-steroidal anti-inflammatory drugs (NSAIDs) due to age, comorbidity or co-prescribing. Outcome measure Initiation of a new NSAID prescription in an encounter between GPs and eligible patients. Results A new high-risk NSAID was initiated in 1953 encounters (1.1% of encounters, 7.4% of patients). Older patients, those with more vulnerabilities to NSAID ADEs and those with polypharmacy were less likely to have a high-risk NSAID initiated, consistent with GPs generally recognising the risk of NSAIDs in eligible patients. Male GPs were more likely to initiate a high-risk NSAID than female GPs (OR 1.73, 95% CI 1.39 to 2.16). After accounting for patient characteristics, 4.2% (95% CI 2.1 to 8.3) of the variation in high-risk NSAID prescribing was attributable to variation between practices, and 14.2% (95% CI 11.4 to 17.3) to variation between GPs. Three practices had statistically higher than average high-risk prescribing, but only 15.7% of GPs with higher than average high-risk prescribing and 18.5% of patients receiving such a prescription were in these practices. Conclusions There was much more variation in high-risk prescribing between GPs than between practices, and only targeting practices with higher than average rates will miss most high-risk NSAID prescribing. Primary care prescribing safety improvement should ideally target all practices, but encourage practices to consider and act on variation between prescribers in the practice.

Background The escalating use of prescribed drugs has increasingly raised concerns about polypharmacy. This study aims to examine changes in rates of polypharmacy and potentially serious drug-drug interactions in a stable geographical population between 1995 and 2010. Methods This is a repeated cross-sectional analysis of community-dispensed prescribing data for all 310,000 adults resident in the Tayside region of Scotland in 1995 and 2010. The number of drug classes dispensed and the number of potentially serious drug-drug interactions (DDIs) in the previous 84 days were calculated, and age-sex standardised rates in 1995 and 2010 compared. Patient characteristics associated with receipt of ≥10 drugs and with the presence of one or more DDIs were examined using multilevel logistic regression to account for clustering of patients within primary care practices. Results Between 1995 and 2010, the proportion of adults dispensed ≥5 drugs doubled to 20.8%, and the proportion dispensed ≥10 tripled to 5.8%. Receipt of ≥10 drugs was strongly associated with increasing age (20–29 years, 0.3%; ≥80 years, 24.0%; adjusted OR, 118.3; 95% CI, 99.5–140.7) but was also independently more common in people living in more deprived areas (adjusted OR most vs. least deprived quintile, 2.36; 95% CI, 2.22–2.51), and in people resident in a care home (adjusted OR, 2.88; 95% CI, 2.65–3.13). The proportion with potentially serious drug-drug interactions more than doubled to 13% of adults in 2010, and the number of drugs dispensed was the characteristic most strongly associated with this (10.9% if dispensed 2–4 drugs vs. 80.8% if dispensed ≥15 drugs; adjusted OR, 26.8; 95% CI 24.5–29.3). Conclusions Drug regimens are increasingly complex and potentially harmful, and people with polypharmacy need regular review and prescribing optimisation. Research is needed to better understand the impact of multiple interacting drugs as used in real-world practice and to evaluate the effect of medicine optimisation interventions on quality of life and mortality. Electronic supplementary material The online version of this article (doi:10.1186/s12916-015-0322-7) contains supplementary material, which is available to authorized users.

Background Three arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations. Methods We identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript. Results Our analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals. Conclusions The logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.

Objective To explore how different practices responded to the Data-driven Quality Improvement in Primary Care (DQIP) intervention in terms of their adoption of the work, reorganisation to deliver the intended change in care to patients, and whether implementation was sustained over time. Design Mixed-methods parallel process evaluation of a cluster trial, reporting the comparative case study of purposively selected practices. Setting Ten (30%) primary care practices participating in the trial from Scotland, UK. Results Four practices were sampled because they had large rapid reductions in targeted prescribing. They all had internal agreement that the topic mattered, made early plans to implement including assigning responsibility for work and regularly evaluated progress. However, how they internally organised the work varied. Six practices were sampled because they had initial implementation failure. Implementation failure occurred at different stages depending on practice context, including internal disagreement about whether the work was worthwhile, and intention but lack of capacity to implement or sustain implementation due to unfilled posts or sickness. Practice context was not fixed, and most practices with initial failed implementation adapted to deliver at least some elements. All interviewed participants valued the intervention because it was an innovative way to address on an important aspect of safety (although one of the non-interviewed general practitioners in one practice disagreed with this). Participants felt that reviewing existing prescribing did influence their future initiation of targeted drugs, but raised concerns about sustainability. Conclusions Variation in implementation and effectiveness was associated with differences in how practices valued, engaged with and sustained the work required. Initial implementation failure varied with practice context, but was not static, with most practices at least partially implementing by the end of the trial. Practices organised their delivery of changed care to patients in ways which suited their context, emphasising the importance of flexibility in any future widespread implementation. Trial registration number NCT01425502.

Objectives To determine the extent to which practice level scores mask variation in individual performance between doctors within a practice. Design Analysis of postal survey of patients’ experience of face-to-face consultations with individual general practitioners in a stratified quota sample of primary care practices. Setting Twenty five English general practices, selected to include a range of practice scores on doctor-patient communication items in the English national GP Patient Survey. Participants 7721 of 15 172 patients (response rate 50.9%) who consulted with 105 general practitioners in 25 practices between October 2011 and June 2013. Main outcome measure Score on doctor-patient communication items from post-consultation surveys of patients for each participating general practitioner. The amount of variance in each of six outcomes that was attributable to the practices, to the doctors, and to the patients and other residual sources of variation was calculated using hierarchical linear models. Results After control for differences in patients’ age, sex, ethnicity, and health status, the proportion of variance in communication scores that was due to differences between doctors (6.4%) was considerably more than that due to practices (1.8%). The findings also suggest that higher performing practices usually contain only higher performing doctors. However, lower performing practices may contain doctors with a wide range of communication scores. Conclusions Aggregating patients’ ratings of doctors’ communication skills at practice level can mask considerable variation in the performance of individual doctors, particularly in lower performing practices. Practice level surveys may be better used to “screen” for concerns about performance that require an individual level survey. Higher scoring practices are unlikely to include lower scoring doctors. However, lower scoring practices require further investigation at the level of the individual doctor to distinguish higher and lower scoring general practitioners.

Background Safety is increasingly conceptualised as a system rather than an individual physician problem, but few studies examine whether high-risk behaviour varies more between physicians or between primary care practices. Primary care prescribing is a common cause of serious harm, being associated with ∼6.5% of all emergency hospital admissions. The aim of this study was to examine variation in high-risk risk prescribing between physicians and between practices. Methods Multilevel logistic regression modelling …

Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of acute kidney injury (AKI) when used in triple combination with renin–angiotensin system inhibitors and diuretics, but previous research reported that NSAIDs in dual combinations with either renin–angiotensin system inhibitors or diuretics alone were not. However, earlier studies relied on hospital coding to define AKI, which may underestimate true risk. This nested case–control study characterized the risk of community-acquired AKI associated with NSAID use among 78,379 users of renin–angiotensin system inhibitors and/or diuretics, where AKI was defined as a 50% or greater increase in creatinine from baseline. The AKI incidence was 68/10,000 person-years. The relative increase in AKI risk was similar for NSAID use in both triple (adjusted rate ratio 1.64 (95% CI 1.25–2.14)) and dual combinations with either renin–angiotensin system inhibitors (1.60 (1.18–2.17)) or diuretics (1.64 (1.17–2.29)). However, the absolute increase in AKI risk was higher for NSAIDs used in triple versus dual combinations with renin–angiotensin system inhibitors or diuretics alone (numbers needed to harm for 1 year treatment with NSAID of 158 vs. over 300). AKI risk was highest among users of loop diuretic/aldosterone antagonist combinations, in those over 75 years of age, and in those with renal impairment. Thus, the nephrotoxic potential of both dual and triple combinations of NSAIDs with renin–angiotensin system inhibitors and/or diuretics yields a higher incidence of AKI than previously thought.

Objectives (A) To measure the extent to which different candidate outcome measures identified high-risk prescribing that is potentially changeable by the data-driven quality improvement in primary care (DQIP) intervention.(B) To explore the value of reviewing identified high-risk prescribing to clinicians.(C) To optimise the components of the DQIP intervention. Design Mixed method study. Setting General practices in two Scottish Health boards. Participants 4 purposively sampled general practices of varying size and socioeconomic deprivation. Outcome measures Prescribing measures targeting (1) high-risk use of the non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelets; (2) ‘Asthma control’ and (3) ‘Antithrombotics in atrial fibrillation (AF)’. Intervention The prescribing measures were used to identify patients for review by general practices. The ability of the measures to identify potentially changeable high-risk prescribing was measured as the proportion of patients reviewed where practices identified a need for action. Field notes were recorded from meetings between researchers and staff and key staff participated in semistructured interviews exploring their experience of the piloted intervention processes. Results Practices identified a need for action in 68%, 25% and 18% of patients reviewed for prescribing measures (1), (2) and (3), respectively. General practitioners valued being prompted to review patients, and perceived that (1) ‘NSAID and antiplatelet’ and (2) ‘antithrombotics in AF’ were the most important to act on. Barriers to initial and ongoing engagement and to sustaining improvements in prescribing were identified. Conclusions ‘NSAIDs and antiplatelets’ measures were selected as the most suitable outcome measures for the DQIP trial, based on evidence of this prescribing being more easily changeable. In response to the barriers identified, the intervention was designed to include a financial incentive, additional ongoing feedback on progress and reprompting review of patients, whose high-risk prescribing was restarted after a decision to stop. Trial registration number Clinicaltrials.gov NCT01425502.

The stepped wedge design, under which all trial participants receive the intervention but the order in which the intervention is received is randomised, is potentially useful to rigorously evaluate organisational interventions to improve quality and safety. We use two examples of cluster-randomised stepped-wedge trials (DQIP and GP-POLY) to illustrate advantages and disadvantages of the design in evaluations of complex prescribing improvement interventions in primary care. DQIP is nearing completion and GP-POLY will start in 2013. The intervention in both DQIP and GP-Poly involves outreach visits by researchers for education and informatics tool training, making sequential roll out a logistic necessity. The stepped wedge allows for this by design, but trial durations may be prolonged compared to parallel-arm trials and other designs, and arranging initiation visits to fit with randomisation schedules is challenging. Since all participants receive the intervention and there are multiple repeated measurements, practice sample size requirements in DQIP and GP-POLY were reduced compared to a parallel-arm design, but power calculations are more complex. Recruitment may be improved by offering the intervention to all participants, but creates potential problems for retention and avoiding contamination in practices with long lags between recruitment and intervention start. Because of the vulnerability of stepped wedge trials to time varying confounding, avoiding changes in intervention delivery to successive cohorts is important and needs careful planning. The stepped wedge design is attractive for cluster randomised trials of quality improvement interventions, especially when staggering of intervention delivery is inevitable, but presents challenges for implementation that need careful planning. Oral presentation presented at the 2nd Clinical Trials Methodology Conference 2013: Methodology matters, 18-19 November 2013, Edinburgh, UK.

Background: Addressing the problem of preventable drug related morbidity (PDRM) in primary care is a challenge for health care systems internationally. The increasing implementation of clinical information systems in the UK and internationally provide new opportunities to systematically identify patients at risk of PDRM for targeted medication review. The objectives of this study were (1) to develop a set of explicit medication assessment criteria to identify patients with sub-optimally effective or high-risk medication use from electronic medical records and (2) to identify medication use topics that are perceived by UK primary care clinicians to be priorities for quality and safety improvement initiatives.\ud \ud Methods: For objective (1), a 2-round consensus process based on the RAND/UCLA Appropriateness Method (RAM) was conducted, in which candidate criteria were identified from the literature and scored by a panel of 10 experts for 'appropriateness' and 'necessity'. A set of final criteria was generated from candidates accepted at each level. For objective (2), thematically related final criteria were clustered into 'topics', from which a panel of 26 UK primary care clinicians identified priorities for quality improvement in a 2-round Delphi exercise.\ud \ud Results: (1) The RAM process yielded a final set of 176 medication assessment criteria organised under the domains 'quality' and 'safety', each classified as targeting 'appropriate/necessary to do' (quality) or 'inappropriate/necessary to avoid' (safety) medication use. Fifty-two final 'quality' assessment criteria target patients with unmet indications, sub-optimal selection or intensity of beneficial drug treatments. A total of 124 'safety' assessment criteria target patients with unmet needs for risk-mitigating agents, high-risk drug selection, excessive dose or duration, inconsistent monitoring or dosing instructions. (2) The UK Delphi panel identified 11 (23%) of 47 scored topics as 'high priority' for quality improvement initiatives in primary care.\ud \ud Conclusions: The developed criteria set complements existing medication assessment instruments in that it is not limited to the elderly, can be implemented in electronic data sets and focuses on drug groups and conditions implicated in common and/or severe PDRM in primary care. Identified priorities for quality and safety improvement can guide the selection of targets for initiatives to address the PDRM problem in primary care.

Objective To examine the prevalence and patterns of high risk prescribing, defined as potentially inappropriate prescribing of drugs to primary care patients particularly vulnerable to adverse drug events.Design Cross sectional population database analysis.Setting General practices in Scotland.Participants 315 Scottish general practices with 1.76 million registered patients, 139 404 (7.9%) of whom were defined as particularly vulnerable to adverse drug events because of age, comorbidity, or co-prescription.Main outcome measures How reliably each of 15 indicators-four each for non-steroidal anti-inflammatory drugs, co-prescription with warfarin, and prescribing in heart failure, two for dose instructions for methotrexate, and one for antipsychotic prescribing in dementia-and a composite of all 15 could distinguish practices in terms of their rates of high risk prescribing; and characteristics of patients and practices associated with high risk prescribing in a multilevel model.Results 19 308 of 139 404 (13.9%, 95% confidence interval 13.7% to 14.0%) patients had received at least one high risk prescription in the past year. This composite indicator was a reasonably reliable measure of practice rates of high risk prescribing (reliability >0.7 for 95.6% of practices, >0.8 for 88.2%). The patient characteristic most strongly associated with high risk prescribing was the number of drugs prescribed (>11 long term prescribed drugs v 0; odds ratio 7.90, 95% confidence interval 7.19 to 8.68). After adjustment for patient characteristics, rates of high risk prescribing varied by fourfold between practices, which was not explained by structural characteristics of the practices.Conclusions Almost 14% of patients defined as particularly vulnerable to adverse drug events were prescribed one or more high risk drugs. The composite indicator of high risk prescribing used could identify practices as having above average or below average high risk prescribing rates with reasonable confidence. After adjustment, only the number of drugs prescribed long term to patients was strongly associated with high risk prescribing, and considerable unexplained variation existed between practices. High risk prescribing will often be appropriate, but the large variation between practices suggests opportunities for improvement.

Background Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants’ perceptions about which intervention elements were active in changing their practice. Methods Data generation was by in-depth interview with key staff exploring participant’s perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory. Results All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness. Conclusions This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention. Trial registration ClinicalTrials.gov, NCT01425502. Electronic supplementary material The online version of this article (doi:10.1186/s13012-016-0531-2) contains supplementary material, which is available to authorized users.

Background High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT)-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable. Methods/design We will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters) that agree to take part will receive the data-driven quality improvement in primary care (DQIP) intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patient's relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR) up front and a small payment of 15 GBP (24 USD; 17 EUR) for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will additionally be a process and economic evaluation alongside the main trial. Discussion The DQIP intervention is an example of a potentially sustainable safety improvement intervention that builds on the existing National Health Service IT-infrastructure to facilitate systematic management of high-risk prescribing by existing practice staff. Although the focus in this trial is on Non-steroidal anti-inflammatory drugs and antiplatelets, we anticipate that the tested intervention would be generalisable to other types of prescribing if shown to be effective. Trial registration ClinicalTrials.gov, dossier number: NCT01425502

Process evaluations are recommended to open the 'black box' of complex interventions evaluated in trials, but there is limited guidance to help with design, with most guidance focused on the use of qualitative methods rather than processes to evaluate. We have developed a framework that identifies a range of candidate processes that an evaluation could examine to understand clusterrandomised intervention implementation and maintenance. These include processes involving clusters (recruitment, delivery of the intervention to the cluster, adoption by the cluster), involving the individuals on whom outcomes are measured (reach, delivery of the intervention to the individual, response of the individual), maintenance, and unintended consequences. Researchers will often have to choose what to focus on because of resource constraints, the framework aims to help researchers make explicit their choices of research questions and methods. We will illustrate application of the framework to the design and conduct of a parallel process evaluation of the Data-driven Quality Improvement in Primary Care trial, which evaluates a complex intervention to improve prescribing safety in 40 general practices. This mixed method process evaluation includes a dominant case study approach in a purposeful sample of practices and hypothesis?testing quantitative analysis of data from all practices examining how key processes are associated with variation in outcome between practices. We will present analysis of qualitative data from the 10 case study practices participating (6 reducing and 4 not reducing targeted prescribing), and focus groups with patients who have had their medication changed as a result of the intervention. Oral presentation presented at the 2nd Clinical Trials Methodology Conference 2013: Methodology matters, 18-19 November 2013, Edinburgh, UK.