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Background: Diagnostic error is a global patient safety priority., Objectives: To estimate the incidence, origins and avoidable harm of diagnostic errors in English general practice. Diagnostic errors were defined as missed opportunities to make a correct or timely diagnosis based on the evidence available (missed diagnostic opportunities, MDOs)., Method: Retrospective medical record reviews identified MDOs in 21 general practices. In each practice, two trained general practitioner reviewers independently conducted case note reviews on 100 randomly selected adult consultations performed during 2013-2014. Consultations where either reviewer identified an MDO were jointly reviewed., Results: Across 2057 unique consultations, reviewers agreed that an MDO was possible, likely or certain in 89 cases or 4.3% (95% CI 3.6% to 5.2%) of reviewed consultations. Inter-reviewer agreement was higher than most comparable studies (Fleiss' kappa=0.63). Sixty-four MDOs (72%) had two or more contributing process breakdowns. Breakdowns involved problems in the patient-practitioner encounter such as history taking, examination or ordering tests (main or secondary factor in 61 (68%) cases), performance and interpretation of diagnostic tests (31; 35%) and follow-up and tracking of diagnostic information (43; 48%). 37% of MDOs were rated as resulting in moderate to severe avoidable patient harm., Conclusions: Although MDOs occurred in fewer than 5% of the investigated consultations, the high numbers of primary care contacts nationally suggest that several million patients are potentially at risk of avoidable harm from MDOs each year. Causes of MDOs were frequently multifactorial, suggesting the need for development and evaluation of multipronged interventions, along with policy changes to support them., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objective: To estimate the incidence of avoidable significant harm in primary care in England; describe and classify the associated patient safety incidents and generate suggestions to mitigate risks of ameliorable factors contributing to the incidents., Design: Retrospective case note review. Patients with significant health problems were identified and clinical judgements were made on avoidability and severity of harm. Factors contributing to avoidable harm were identified and recorded., Setting: Primary care., Participants: Thirteen general practitioners (GPs) undertook a retrospective case note review of a sample of 14 407 primary care patients registered with 12 randomly selected general practices from three regions in England (total list size: 92 255 patients)., Main Outcome Measures: The incidence of significant harm considered at least 'probably avoidable' and the nature of the safety incidents., Results: The rate of significant harm considered at least probably avoidable was 35.6 (95% CI 23.3 to 48.0) per 100 000 patient-years (57.9, 95% CI 42.2 to 73.7, per 100 000 based on a sensitivity analysis). Overall, 74 cases of avoidable harm were detected, involving 72 patients. Three types of incident accounted for more than 90% of the problems: problems with diagnosis accounted for 45/74 (60.8%) primary incidents, followed by medication-related problems (n=19, 25.7%) and delayed referrals (n=8, 10.8%). In 59 (79.7%) cases, the significant harm could have been identified sooner (n=48) or prevented (n=11) if the GP had taken actions aligned with evidence-based guidelines., Conclusion: There is likely to be a substantial burden of avoidable significant harm attributable to primary care in England with diagnostic error accounting for most harms. Based on the contributory factors we found, improvements could be made through more effective implementation of existing information technology, enhanced team coordination and communication, and greater personal and informational continuity of care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: For the first 5 years of the UK primary care pay for performance scheme, the Quality and Outcomes Framework (QOF), quality indicators were introduced without piloting. However, in 2009, potential new indicators were piloted in a nationally representative sample of practices. This paper describes an in-depth exploration of family physician, nurse and other primary-care practice staff views of the value of piloting with a particular focus on unintended consequences of 13 potential new QOF indicators., Method: Fifty-seven family-practice professionals were interviewed in 24 representative practices across England., Results: Almost all interviewees emphasised the value of piloting in terms of an opportunity to identify unintended consequences of potential QOF indicators in 'real world' settings with staff who deliver day-to-day care to patients. Four particular types of unintended consequences were identified: measure fixation, tunnel vision, misinterpretation and potential gaming. 'Measure fixation,' an inappropriate attention on isolated aspects of care, appeared to be the key unintended consequence. In particular, if the palliative care indicator had been introduced without piloting, this might have incentivised poorer care in a minority of practices with potential harm to vulnerable patients., Conclusions: It is important to identify concerns and experiences about unintended consequences of indicators at an early stage when there is time to remove or adapt problem indicators. Since the UK government currently spends over £1 billion each year on QOF, the £150,000 spent on each piloting cohort (0.0005% of the total QOF budget) appears to be good value for money.

Background: At present there is no internationally agreed definition of occupational asthma and there is a lack of guidance regarding the resources that should be readily available to physicians running specialist occupational asthma services., Aims: To agree a working definition of occupational asthma and to develop a framework of resources necessary to run a specialist occupational asthma clinic., Method: A modified RAND appropriateness method was used to gain a consensus of opinion from an expert panel of clinicians running specialist occupational asthma clinics in the UK., Results: Consensus was reached over 10 terms defining occupational asthma including: occupational asthma is defined as asthma induced by exposure in the working environment to airborne dusts vapours or fumes, with or without pre-existing asthma; occupational asthma encompasses the terms "sensitiser-induced asthma" and "acute irritant-induced asthma" (reactive airways dysfunction syndrome (RADS)); acute irritant-induced asthma is a type of occupational asthma where there is no latency and no immunological sensitisation and should only be used when a single high exposure has occurred; and the term "work-related asthma" can be used to include occupational asthma, acute irritant-induced asthma (RADS) and aggravation of pre-existing asthma. Disagreement arose on whether low dose irritant-induced asthma existed, but the panel agreed that if it did exist they would include it in the definition of "work-related asthma". The panel agreed on a set of 18 resources which should be available to a specialist occupational asthma service. These included pre-bronchodilator FEV1 and FVC (% predicted); peak flow monitoring (and plotting of results, OASYS II analysis); non-specific provocation challenge in the laboratory and specific IgE to a wide variety of occupational agents., Conclusion: It is hoped that the outcome of this process will improve uniformity of definition and investigation of occupational asthma across the UK.

Background: While mental health is a core part of primary care, there are few validated quality measures and little relevant internationally published research. Consensus panel methods are a useful means of developing quality measures where evidence is sparse and/or opinions are diverse. However, little is known about the dynamics of consensus techniques and the factors that influence the judgements and ratings of panels and individual panelists., Objectives: (1) To describe differences in panel ratings on the quality of primary mental health care services by patient, carer, professional and managerial panels within a Delphi procedure; and (2) to explore why different panels and panelists rate quality indicators of primary mental health care differently., Design: Two round postal Delphi technique and exploratory semi-structured interviews., Participants: 115 panelists across 11 panels. Eleven panelists were subsequently interviewed., Results: 87 of 334 indicators (26%) were rated face valid by all 11 panels. There was little disagreement within panel ratings but significant differences between panels. The GP panel rated the least number of indicators valid (n = 138, 41%) and carers the most (n = 304, 91%). The way in which panelists interpreted and conceptualised the indicators and their definition of quality of mental health care affected the way in which participants made their ratings., Conclusions: Stakeholders in primary mental health care have diverse views of quality of care and these differences translate into how they rate quality indicators. Exploratory interviews suggest that ratings are influenced by past experience, expectations, definitions of quality of care, and perceived power relationships between stakeholders.

Background: A series of government initiatives in the UK have included strategies to improve the quality of services received by patients, including fundholding, the development of National Service Frameworks, clinical governance, and Personal Medical Services (PMS). PMS represents a new contractual arrangement between government and general practitioners (GPs) which provides new investment in return for more detailed specification of processes and outcomes of care., Objectives: To evaluate the effects of PMS on the quality of primary mental health care between 1998 and 2001., Design: Multiple longitudinal case studies. Semi-structured interviews with key staff within practices (GPs, nurses, practice managers) and outside (health authority and primary care group/trust managers)., Sample: Six first wave PMS sites which had specifically planned to improve their mental health care., Results: Improvements in mental health care were found in some PMS practices and not in others. Five mechanisms associated with successful quality improvement in mental health were identified: clear goals, effective teamwork within the practice, routine use of protocols and audits, additional resources, and effective collaboration with community and secondary care. Sites where these factors were not present struggled to meet their objectives., Conclusion: The five mechanisms which resulted in improved mental health care were facilitated by the new contractual arrangements in PMS. The new contracts were not a necessary part of these changes, but they enabled sites with an identified interest and motivation to make the changes. The contractual changes were not in themselves sufficient to improve care.

Objective: To investigate practical and methodological problems in assessing the quality of care of multiple conditions in general practice., Setting: Sixteen general practices from two socioeconomically diverse regions in the UK., Method: Quality of care was assessed in 100 randomly selected patient records in each practice using an established set of quality indicators covering 23 conditions commonly seen in primary care. Inter-rater reliability assessment was carried out for five of the conditions., Results: Conducting simultaneous quality assessment across multiple conditions is highly resource intensive. Poor data quality and the low prevalence of some items of care defined by the indicators are significant problems. Scores for individual indicators require very large samples for reliable assessment. Quality scores are more reliable when reported at a higher unit of analysis. This is particularly true for indicators and conditions with low prevalence where data may need to be aggregated to the level of groups of conditions or organisational providers. There is no single ideal way of aggregating quality scores., Conclusion: The study identified some of the practical and methodological difficulties in assessing quality of care across multiple conditions. For improved quality assessment, advances in information technology and improvements in data quality are required for more efficient and reliable data extraction from medical records, together with the development of methods for combining scores across indicators, conditions, and practices. However, electronic data extraction methods will still be based on the assumption that the care recorded reflects the care provided.

Quality indicators have been developed throughout Europe primarily for use in hospitals, but also increasingly for primary care. Both development and application are important but there has been less research on the application of indicators. Three issues are important when developing or applying indicators: (1). which stakeholder perspective(s) are the indicators intended to reflect; (2). what aspects of health care are being measured; and (3). what evidence is available? The information required to develop quality indicators can be derived using systematic or non-systematic methods. Non-systematic methods such as case studies play an important role but they do not tap in to available evidence. Systematic methods can be based directly on scientific evidence by combining available evidence with expert opinion, or they can be based on clinical guidelines. While it may never be possible to produce an error free measure of quality, measures should adhere, as far as possible, to some fundamental a priori characteristics (acceptability, feasibility, reliability, sensitivity to change, and validity). Adherence to these characteristics will help maximise the effectiveness of quality indicators in quality improvement strategies. It is also necessary to consider what the results of applying indicators tell us about quality of care.

Objectives: To field test the reliability, validity, and acceptability of review criteria for angina, asthma, and type 2 diabetes which had been developed by expert panels using a systematic process to combine evidence with expert opinion., Design: Statistical analysis of data derived from a clinical audit, and postal questionnaire and semi-structured interviews with general practitioners and practice nurses in a representative sample of general practices in England., Setting: 60 general practices in England., Main Outcome Measures: Clinical audit results for angina, asthma, and type 2 diabetes. General practitioner and practice nurse validity ratings from the postal questionnaire., Results: 54%, 59%, and 70% of relevant criteria rated valid by the expert panels for angina, asthma, and type 2 diabetes, respectively, were found to be usable, valid, reliable, and acceptable for assessing quality of care. General practitioners and practice nurses agreed with panellists that these criteria were valid but not that they should always be recorded in the medical record., Conclusion: Quality measures derived using expert panels need field testing before they can be considered valid, reliable, and acceptable for use in quality assessment. These findings provide additional evidence that the RAND panel method develops valid and reliable review criteria for assessing clinical quality of care.

Objectives: To investigate the concept of clinical governance being advocated by primary care groups/trusts (PCG/Ts), approaches being used to implement clinical governance, and potential barriers to its successful implementation in primary care., Design: Qualitative case studies using semi-structured interviews and documentation review., Setting: Twelve purposively sampled PCG/Ts in England., Participants: Fifty senior staff including chief executives, clinical governance leads, mental health leads, and lay board members., Main Outcome Measures: Participants' perceptions of the role of clinical governance in PCG/Ts., Results: PCG/Ts recognise that the successful implementation of clinical governance in general practice will require cultural as well as organisational changes, and the support of practices. They are focusing their energies on supporting practices and getting them involved in quality improvement activities. These activities include, but move beyond, conventional approaches to quality assessment (audit, incentives) to incorporate approaches which emphasise corporate and shared learning. PCG/Ts are also engaged in setting up systems for monitoring quality and for dealing with poor performance. Barriers include structural barriers (weak contractual levers to influence general practices), resource barriers (perceived lack of staff or money), and cultural barriers (suspicion by practice staff or problems overcoming the perceived blame culture associated with quality assessment)., Conclusion: PCG/Ts are focusing on setting up systems for implementing clinical governance which seek to emphasise developmental and supportive approaches which will engage health professionals. Progress is intentionally incremental but formidable challenges lie ahead, not least reconciling the dual role of supporting practices while monitoring (and dealing with poor) performance.

Objectives: Little is known about the quality of clinical care provided outside the hospital sector, despite the increasingly important role of clinical generalists working in primary care. In this study we aimed to summarise published evaluations of the quality of clinical care provided in general practice in the UK, Australia, and New Zealand., Design: A systematic review of published studies assessing the quality of clinical care in general practice for the period 1995-9., Setting: General practice based care in the UK, Australia, and New Zealand. Main outcome measures-Study design, sampling strategy and size, clinical conditions studied, quality of care attained for each condition (compared with explicit or implicit standards for the process of care), and country of origin for each study., Results: Ninety papers fulfilled the entry criteria for the review, 80 from the UK, six from Australia, and four from New Zealand. Two thirds of the studies assessed care in self-selected practices and 20% of the studies were based in single practices. The majority (85.5%) examined the quality of care provided for chronic conditions including cardiovascular disease (22%), hypertension (14%), diabetes (14%), and asthma (13%). A further 12% and 2% examined preventive care and acute conditions, respectively. In almost all studies the processes of care did not attain the standards set out in national guidelines or those set by the researchers themselves. For example, in the highest achieving practices 49% of diabetic patients had had their fundii examined in the previous year and 47% of eligible patients had been prescribed beta blockers after an acute myocardial infarction., Conclusions: This study adopts an overview of the magnitude and the nature of clinical quality problems in general practice in three countries. Most of the studies in the systematic review come from the UK and the small number of papers from Australia and New Zealand make it more difficult to draw conclusions about the quality of care in these two countries. The review helps to identify deficiencies in the research, clinical and policy agendas in a part of the health care system where quality of care has been largely ignored to date. Further work is required to evaluate the quality of clinical care in a representative sample of the population, to identify the reasons for substandard care, and to test strategies to improve the clinical care provided in general practice.

Objective: To develop review criteria to assess the quality of care for three major chronic diseases: adult asthma, stable angina, and non-insulin dependent diabetes mellitus., Subjects and Methods: Modified panel process based upon the RAND/UCLA (University College of Los Angeles) appropriateness method. Three multiprofessional panels made up of general practitioners, hospital specialists, and practice nurses., Results: The RAND/UCLA appropriateness method of augmenting evidence with expert opinion was used to develop criteria for the care of the three conditions. Of those aspects of care which were rated as necessary by the panels, only 26% (16% asthma, 10% non-insulin dependent diabetes, 40% angina) were subsequently rated by the panels as being based on strong scientific evidence., Conclusion: The results show the importance of a systematic approach to combining evidence with expert opinion to develop review criteria for assessing the quality of three chronic diseases in general practice. The evidence base for the criteria was often incomplete, and explicit methods need to be used to combine evidence with expert opinion where evidence is not available.