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Background: Irritable bowel syndrome, characterised by abdominal pain and a change in stool form or frequency, is most often managed in primary care. When first-line therapies are ineffective, National Institute for Health and Care Excellence guidelines suggest considering low-dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown and they are infrequently prescribed by general practitioners., Objective: To evaluate the clinical and cost-effectiveness of low-dose titrated amitriptyline as a second-line treatment for irritable bowel syndrome in primary care., Design: A pragmatic, randomised, multicentre, two-arm, double-blind, placebo-controlled trial. A nested, qualitative study explored participant and general practitioner experiences of treatments and trial participation, and implications for wider use of amitriptyline for irritable bowel syndrome in primary care. Participants, clinicians, investigators and analysts were masked to allocation., Setting: Fifty-five general practices in three regions in England (Wessex, West of England, West Yorkshire)., Participants: Patients aged ≥ 18 years meeting Rome IV criteria for irritable bowel syndrome with ongoing symptoms after trying first-line treatments and no contraindications to TCAs., Intervention: Amitriptyline 10 mg once-daily, self-titrated by participants to a maximum of 30 mg once-daily or matched placebo for 6 months. Participants randomised 1 : 1 with most having the option to continue blinded treatment for a further 6 months., Main Outcome Measures: The primary participant-reported outcome was the effect of amitriptyline on global irritable bowel syndrome symptoms at 6 months, measured using the irritable bowel syndrome Severity Scoring System, with a 35-point between-group difference defined as the minimum clinically important difference. The key secondary outcome was the proportion of participants reporting subjective global assessment of relief at 6 months, defined as somewhat, considerable, or complete relief of symptoms. Other secondary outcomes included: effect on global symptoms, via the irritable bowel syndrome Severity Scoring System, and subjective global assessment of relief of irritable bowel syndrome symptoms at 3 and 12 months; effect on somatic symptom-reporting at 6 months; anxiety an-d depression scores; ability to work and participate in other activities at 3, 6 and 12 months; acceptability, tolerability and adherence to trial medication., Results: Four hundred and sixty-three participants were randomised to amitriptyline (232) or placebo (231). An intention-to-treat analysis of the primary outcome showed a significant difference in favour of amitriptyline for irritable bowel syndrome Severity Scoring System score between arms at 6 months [-27.0, 95% confidence interval (CI) -46.9 to -7.10; p = 0.008]. For the key secondary outcome of subjective global assessment of relief of irritable bowel syndrome symptoms, amitriptyline was superior to placebo at 6 months (odds ratio 1.78, 95% CI 1.19 to 2.66; p = 0.005). Amitriptyline was superior to placebo across a range of other irritable bowel syndrome symptom measures but had no impact on somatoform symptom-reporting, anxiety, depression, or work and social adjustment scores. Adverse event trial withdrawals were more common with amitriptyline (12.9% vs. 8.7% for placebo) but most adverse events were mild. The qualitative study thematically analysed 77 semistructured interviews with 42 participants and 16 GPs. Most participants found the self-titration process acceptable and empowering., Conclusions: General practitioners should offer low-dose amitriptyline to patients with irritable bowel syndrome whose symptoms do not improve with first-line therapies. Guidance and resources should support GP-patient communication to distinguish amitriptyline for irritable bowel syndrome from use as an antidepressant and to support patients managing their own dose titration., Study Registration: This trial is registered as ISRCTN48075063., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/162/01) and is published in full in Health Technology Assessment Vol. 28, No. 66. See the NIHR Funding and Awards website for further award information.

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., Competing Interests: The authors have declared that no competing interests exist.

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.

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.

Background: The cancer strategy for England (2015-2020) recommends GPs prescribe tamoxifen for breast cancer primary prevention among women at increased risk., Aim: To investigate GPs' attitudes towards prescribing tamoxifen., Design and Setting: In an online survey, GPs in England, Northern Ireland, and Wales ( n = 928) were randomised using a 2 × 2 between-subjects design to read one of four vignettes describing a healthy patient seeking a tamoxifen prescription., Method: In the vignette, the hypothetical patient's breast cancer risk (moderate versus high) and the clinician initiating the prescription (GP prescriber versus secondary care clinician [SCC] prescriber) were manipulated in a 1:1:1:1 ratio. Outcomes were willingness to prescribe, comfort discussing harms and benefits, comfort managing the patient, factors affecting the prescribing decision, and awareness of tamoxifen and the National Institute for Health and Care Excellence (NICE) guideline CG164., Results: Half (51.7%) of the GPs knew tamoxifen can reduce breast cancer risk, and one-quarter (24.1%) were aware of NICE guideline CG164. Responders asked to initiate prescribing (GP prescriber) were less willing to prescribe tamoxifen than those continuing a prescription initiated in secondary care (SCC prescriber) (68.9% versus 84.6%, P <0.001). The GP prescribers reported less comfort discussing tamoxifen (53.4% versus 62.5%, P = 0.01). GPs willing to prescribe were more likely to be aware of the NICE guideline ( P = 0.039) and to have acknowledged the benefits of tamoxifen ( P <0.001), and were less likely to have considered its off-licence status ( P <0.001)., Conclusion: Initiating tamoxifen prescriptions for preventive therapy in secondary care before asking GPs to continue the patient's care may overcome some prescribing barriers., (© British Journal of General Practice 2017.)

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.

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., (© The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Despite the availability of evidence-based guidance, many patients with type 2 diabetes do not achieve treatment goals., Aim: To guide quality improvement strategies for type 2 diabetes by synthesising qualitative evidence on primary care physicians' and nurses' perceived influences on care., Design and Setting: Systematic review of qualitative studies with findings organised using the Theoretical Domains Framework., Method: Databases searched were MEDLINE, Embase, CINAHL, PsycInfo, and ASSIA from 1980 until March 2014. Studies included were English-language qualitative studies in primary care of physicians' or nurses' perceived influences on treatment goals for type 2 diabetes., Results: A total of 32 studies were included: 17 address general diabetes care, 11 glycaemic control, three blood pressure, and one cholesterol control. Clinicians struggle to meet evolving treatment targets within limited time and resources, and are frustrated with resulting compromises. They lack confidence in knowledge of guidelines and skills, notably initiating insulin and facilitating patient behaviour change. Changing professional boundaries have resulted in uncertainty about where clinical responsibility resides. Accounts are often couched in emotional terms, especially frustrations over patient compliance and anxieties about treatment intensification., Conclusion: Although resources are important, many barriers to improving care are amenable to behaviour change strategies. Improvement strategies need to account for differences between clinical targets and consider tailored rather than 'one size fits all' approaches. Training targeting knowledge is necessary but insufficient to bring about major change; approaches to improve diabetes care need to delineate roles and responsibilities, and address clinicians' skills and emotions around treatment intensification and facilitation of patient behaviour change., (© British Journal of General Practice 2016.)

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.

Background: The place of opioids in the management of chronic, non-cancer pain is limited. Even so their use is escalating, leading to concerns that patients are prescribed strong opioids inappropriately and alternatives to medication are under-used. We aimed to understand the processes which bring about and perpetuate long-term prescribing of opioids for chronic, non-cancer pain., Methods: We held semi-structured interviews with patients and focus groups with general practitioners (GPs). Participants included 23 patients currently prescribed long-term opioids and 15 GPs from Leeds and Bradford, United Kingdom (UK). We used a grounded approach to the analysis of transcripts., Results: Patients are driven by the needs for pain relief, explanation, and improvement or maintenance of quality of life. GPs' responses are shaped by how UK general practice is organised, available therapeutic choices and their expertise in managing chronic pain, especially when facing diagnostic uncertainty or when their own approach is at odds with the patient's wishes. Four features of the resulting transaction between patients and doctors influence prescribing: lack of clarity of strategy, including the risk of any plans being subverted by urgent demands; lack of certainty about locus of control in decision-making, especially in relation to prescribing; continuity in the doctor-patient relationship; and mutuality and trust., Conclusions: Problematic prescribing occurs when patients experience repeated consultations that do not meet their needs and GPs feel unable to negotiate alternative approaches to treatment. Therapeutic short-termism is perpetuated by inconsistent clinical encounters and the absence of mutually-agreed formulations of underlying problems and plans of action. Apart from commissioning improved access to appropriate specialist services, general practices should also consider how they manage problematic opioid prescribing and be prepared to set boundaries with patients.

Background: Detection of depression can be difficult in primary care, particularly when associated with chronic illness. Patient beliefs may affect detection and subsequent engagement with management. Q-methodology can help to identify viewpoints that are likely to influence either clinical practice or policy intervention., Aim: To identify socially shared viewpoints of comorbid depression, and characterise key overlaps and discrepancies., Design and Setting: A Q-methodology study of patients registered with general practices or community clinics in Leeds, UK., Method: Patients with coronary heart disease or diabetes and depression from three practices and community clinics were invited to participate. Participants ranked 57 statements about comorbid depression. Factor analyses were undertaken to identify independent accounts, and additional interview data were used to support interpretation., Results: Thirty-one patients participated; 13 (42%) had current symptoms of depression. Five accounts towards comorbid depression were identified: overwhelmed resources; something medical or within me; a shameful weakness; part of who I am; and recovery-orientated. The main differences in attitudes related to the cause of depression and its relationship with the patient's chronic illness, experience of shame, and whether medical interventions would help recovery., Conclusion: There are groups of patients who do not perceive a relationship between their depression and chronic illness; they may not understand the intention behind policy initiatives to identify depression during chronic illness reviews. Tailoring detection strategies for depression to take account of different clusters of attitudes and beliefs could help improve identification and personalise management., (© British Journal of General Practice 2015.)

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.

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.

Background: Data on the uptake of clinical guidelines into practice are essential to guide and evaluate quality improvement interventions. Organizations responsible for service specification, monitoring and improvement need to consider the practicality of and trade-offs made in different data collection methods. We examined the feasibility of deriving and applying review criteria for clinical guidelines in English primary care., Methods: We selected two sets of guidance, on osteoporosis and depression, and used a consensus process to derive review criteria. We manually extracted data on adherence to review criteria from patient records in 20 general practices from three NHS primary care trusts in northern England. We compared the relative utility of extracted data with that of routinely available data, summarizing feasibility using what we termed a Resource Ratio., Results: Of 53 proposed review criteria we assessed, 41 were judged clinically important, valid, relevant and measurable. Thirty-one could be assessed in 10% or more of sampled patients, whereas 15 could be readily extracted (resource ratio of 15 or less). Only eight met all desirable attributes for use as review criteria. Resource ratios correlated poorly with local stakeholders' prior views on feasibility of data collection. We observed wide variations in compliance with review criteria, with notably low levels among self-care standards., Conclusions: A minority of guideline recommendations were suitable for review criteria development, fewer still when using routinely available data. Local stakeholders tend to underestimate the actual resource requirements of data collection. Although improved design and use of clinical records may facilitate measurement of adherence to recommended practice, detailed assessments are still likely to rely upon some degree of manual data collection in the foreseeable future.

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., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Clinicians are encouraged to screen people with chronic physical illness for depression. Screening alone may not improve outcomes, especially if the process is incompatible with patient beliefs. The aim of this research is to understand people's beliefs about depression, particularly in the presence of chronic physical disease., Methods: A mixed method systematic review involving a thematic analysis of qualitative studies and quantitative studies of beliefs held by people with current depressive symptoms. MEDLINE, EMBASE, PSYCHINFO, CINAHL, BIOSIS, Web of Science, The Cochrane Library, UKCRN portfolio, National Research Register Archive, Clinicaltrials.gov and OpenSIGLE were searched from database inception to 31st December 2010. A narrative synthesis of qualitative and quantitative data, based initially upon illness representations and extended to include other themes not compatible with that framework., Results: A range of clinically relevant beliefs was identified from 65 studies including the difficulty in labeling depression, complex causal factors instead of the biological model, the roles of different treatments and negative views about the consequences of depression. We found other important themes less related to ideas about illness: the existence of a self-sustaining 'depression spiral'; depression as an existential state; the ambiguous status of suicidal thinking; and the role of stigma and blame in depression., Conclusions: Approaches to detection of depression in physical illness need to be receptive to the range of beliefs held by patients. Patient beliefs have implications for engagement with depression screening.

Background: Regular laboratory test monitoring of patient parameters offers a route for improving the quality of chronic disease care. We evaluated the effects of brief educational messages attached to laboratory test reports on diabetes care., Methods: A programme of cluster randomised controlled trials was set in primary care practices in one primary care trust in England. Participants were the primary care practices' constituent healthcare professionals and patients with diabetes. Interventions comprised brief educational messages added to paper and electronic primary care practice laboratory test reports and introduced over two phases. Phase one messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control, and foot inspection. Main outcome measures comprised practice mean HbA1c and cholesterol levels, diastolic and systolic BP, and proportions of patients having undergone foot inspections., Results: Initially, 35 out of 37 eligible practices participated. Outcome data were available for a total of 8,690 patients with diabetes from 32 practices. The BP message produced a statistically significant reduction in diastolic BP (-0.62 mmHg; 95% confidence interval -0.82 to -0.42 mmHg) but not systolic BP (-0.06 mmHg, -0.42 to 0.30 mmHg) and increased the odds of achieving target BP control (odds ratio 1.05; 1.00, 1.10). The foot inspection message increased the likelihood of a recorded foot inspection (incidence rate ratio 1.26; 1.18 to 1.36). The glycaemic control message had no effect on mean HbA1c (increase 0.01%; -0.03 to 0.04) despite increasing the odds of a change in likelihood of HbA1c tests being ordered (OR 1.06; 1.01, 1.11). The cholesterol message had no effect (decrease 0.01 mmol/l, -0.04 to 0.05)., Conclusions: Three out of four interventions improved intermediate outcomes or process of diabetes care. The diastolic BP reduction approximates to relative reductions in mortality of 3% to 5% in stroke and 3% to 4% in ischaemic heart disease over 10 years. The lack of effect for other outcomes may, in part, be explained by difficulties in bringing about further improvements beyond certain thresholds of clinical performance., Trial Registration: Current Controlled Trials, ISRCTN2186314.

Research in primary care has much to offer researchers and ultimately efforts to improve population health and health care. There is a need for capacity building and efforts to improve the science of research in this field. This article outlines a relatively structured career pathway for primary care researchers and offers advice on opportunities and commonly encountered pitfalls. It is largely based upon the authors' experiences and personal reflections as medically trained researchers but many of the implications and lessons are relevant to other clinical and research disciplines.

Background: Improving the quality of health care requires a range of evidence-based activities. Audit and feedback is commonly used as a quality improvement tool in the UK National Health Service [NHS]. We set out to assess whether current guidance and systematic review evidence can sufficiently inform practical decisions about how to use audit and feedback to improve quality of care., Methods: We selected an important chronic disease encountered in primary care: diabetes mellitus. We identified recommendations from National Institute for Clinical Excellence (NICE) guidance on conducting audit and generated questions which would be relevant to any attempt to operationalise audit and feedback in a healthcare service setting. We explored the extent to which a systematic review of audit and feedback could provide practical guidance about whether audit and feedback should be used to improve quality of diabetes care and, if so, how audit and feedback could be optimised., Results: National guidance suggests the importance of securing the right organisational conditions and processes. Review evidence suggests that audit and feedback can be effective in changing healthcare professional practice. However, the available evidence says relatively little about the detail of how to use audit and feedback most efficiently., Conclusion: Audit and feedback will continue to be an unreliable approach to quality improvement until we learn how and when it works best. Conceptualising audit and feedback within a theoretical framework offers a way forward.

Background: Failure to recruit adequate numbers of participants represents a major barrier to the completion of randomized controlled trials in primary care and is associated with substantial opportunity costs. However, uncertainty exists regarding the relative effectiveness of different methods to promote recruitment., Objectives: The purpose of this study was to estimate the proportion of strategies used to promote patient recruitment to randomized controlled trials in primary care that are evidence based., Methods: Investigators from seven primary care-based clinical trials of dyspepsia management aiming to recruit a total of 6070 patients participated. Following a survey of trial organization, a Delphi technique was used to reach consensus on levels of evidence on the effectiveness of interventions or organizational characteristics in influencing recruitment. The main outcome measures were the proportions of interventions or organizational characteristics for influencing patient recruitment that are based upon randomized controlled trials, on convincing non-experimental evidence or meeting neither of these criteria., Results: Out of a total of 56 interventions used across the trials, 35 (63%) were judged as evidence based. Out of a total of 29 organizational characteristics possessed by the trials, five (17%) were judged as evidence based. Across the seven dyspepsia trials, the presence of 'favourable' organizational characteristics appeared to be important contributors towards successful recruitment., Conclusions: A wide range of interventions and organizational characteristics with the potential to promote recruitment were used or possessed by seven primary care trials. Many were not evidence based. Our experience suggests that organizational characteristics could be more influential in trial recruitment than the use of specific interventions. Given the costs of primary care-based trials, researchers need more rigorous evidence to inform recruitment strategies.

Background: Recent guidelines have suggested that testing young dyspeptic patients for Helicobacter pylori infection will produce more appropriate referrals for endoscopic investigation. Our aim was to describe how awareness of patient H. pylori status changes the practice of general practitioners (GPs) who do not currently use H. pylori testing and/or eradication in their management of dyspepsia. We studied a 5 per cent systematic sample (n = 177), stratified by health authority, of GPs in the North West region of England., Methods: A questionnaire-based assessment of self-reported practice of young patients with dyspepsia was carried out., Results: Over three-quarters of GPs would choose eradication therapy rather than ulcer healing drugs if they knew the patient was positive for H. pylori infection. Twenty-nine per cent of GPs would refer for endoscopy when the patient's H. pylori status was unknown, 32 per cent when it was positive, and 22 per cent when it was negative. However, GPs responded in an inconsistent manner to knowledge of patient H. pylori status. Some chose to refer positive patients only, others only patients with negative status, and a minority would refer both positive and negative patients., Conclusions: Until the use of H. pylori tests in primary care populations has been evaluated in appropriate prospective randomized controlled trials, advocates of testing as a means to reduce endoscopy referrals should be cautious about its potential impact on service workload.