Associations between exemption and survival outcomes in the UK's primary care pay-for-performance programme:a retrospective cohort study

PublishedJournal ArticleThis is the final version of the article. Available from BMJ Publishing Group via the DOI in this record.OBJECTIVES: The UK's Quality and Outcomes Framework permits practices to exempt patients from financially-incentivised performance targets. To better understand the determinants and consequences of being exempted from the framework, we investigated the associations between exception reporting, patient characteristics and mortality. We also quantified the proportion of exempted patients that met quality targets for a tracer condition (diabetes). DESIGN: Retrospective longitudinal study, using individual patient data from the Clinical Practice Research Datalink. SETTING: 644 general practices, 2006/7 to 2011/12. PARTICIPANTS: Patients registered with study practices for at least one year over the study period, with at least one condition of interest (2 460 341 in total). MAIN OUTCOME MEASURES: Exception reporting rates by reason (clinical contraindication, patient dissent); all-cause mortality in year following exemption. Analyses with logistic and Cox proportional-hazards regressions, respectively. RESULTS: The odds of being exempted increased with age, deprivation and multimorbidity. Men were more likely to be exempted but this was largely attributable to higher prevalence of conditions with high exemption rates. Modest associations remained, with women more likely to be exempted due to clinical contraindication (OR 0.90, 99% CI 0.88 to 0.92) and men more likely to be exempted due to informed dissent (OR 1.08, 99% CI 1.06 to 1.10). More deprived areas (both for practice location and patient residence) were non-linearly associated with higher exception rates, after controlling for comorbidities and other covariates, with stronger associations for clinical contraindication. Compared with patients with a single condition, odds ratios for patients with two, three, or four or more conditions were respectively 4.28 (99% CI 4.18 to 4.38), 16.32 (99% CI 15.82 to 16.83) and 68.69 (99% CI 66.12 to 71.37) for contraindication, and 2.68 (99% CI 2.63 to 2.74), 4.02 (99% CI 3.91 to 4.13) and 5.17 (99% CI 5.00 to 5.35) for informed dissent. Exempted patients had a higher adjusted risk of death in the following year than non-exempted patients, regardless of whether this exemption was for contraindication (hazard ratio 1.37, 99% CI 1.33 to 1.40) or for informed dissent (1.20, 99% CI 1.17 to 1.24). On average, quality standards were met for 48% of exempted patients in the diabetes domain, but there was wide variation across indicators (ranging from 8 to 80%). CONCLUSIONS: Older, multimorbid and more deprived patients are more likely to be exempted from the scheme. Exception reported patients are more likely to die in the following year, whether they are exempted by the practice for a contraindication or by themselves through informed dissent. Further research is needed to understand the relationship between exception reporting and patient outcomes.NIHR School for Primary Care Research (Project #141); Medical Research Council; Health eResearch Centre grant MR/K006665/1

Applications of simple and accessible methods for meta-analysis involving rare events: A simulation study

Meta-analysis of clinical trials targeting rare events face particular challenges when the data lack adequate number of events and are susceptible to high levels of heterogeneity. The standard meta-analysis methods (DerSimonian Laird (DL) and Mantel–Haenszel (MH)) often lead to serious distortions because of such data sparsity. Applications of the methods suited to specific incidence and heterogeneity characteristics are lacking, thus we compared nine available methods in a simulation study. We generated 360 meta-analysis scenarios where each considered different incidences, sample sizes, between-study variance (heterogeneity) and treatment allocation. We include globally recommended methods such as inverse-variance fixed/random-effect (IV-FE/RE), classical-MH, MH-FE, MH-DL, Peto, Peto-DL and the two extensions for MH bootstrapped-DL (bDL) and Peto-bDL. Performance was assessed on mean bias, mean error, coverage and power. In the absence of heterogeneity, the coverage and power when combined revealed small differences in meta-analysis involving rare and very rare events. The Peto-bDL method performed best, but only in smaller sample sizes involving rare events. For medium-to-larger sample sizes, MH-bDL was preferred. For meta-analysis involving very rare events, Peto-bDL was the best performing method which was sustained across all sample sizes. However, in meta-analysis with 20% or more heterogeneity, the coverage and power were insufficient. Performance based on mean bias and mean error was almost identical across methods. To conclude, in meta-analysis of rare binary outcomes, our results suggest that Peto-bDL is better in both rare and very rare event settings in meta-analysis with limited sample sizes. However, when heterogeneity is large, the coverage and power to detect rare events are insufficient. Whilst this study shows that some of the less studied methods appear to have good properties under sparse data scenarios, further work is needed to assess them against the more complex distributional-based methods to understand their overall performances

Long-term glycemic variability and risk of adverse outcomes: a systematic review and meta-analysis

OBJECTIVE: Glycemic variability is emerging as a measure of glycemic control, which may be a reliable predictor of complications. This systematic review and meta-analysis evaluates the association between HbA1c variability and micro- and macrovascular complications and mortality in type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS: Medline and Embase were searched (2004–2015) for studies describing associations between HbA1c variability and adverse outcomes in patients with type 1 and type 2 diabetes. Data extraction was performed independently by two reviewers. Random-effects meta-analysis was performed with stratification according to the measure of HbA1c variability, method of analysis, and diabetes type. RESULTS: Seven studies evaluated HbA1c variability among patients with type 1 diabetes and showed an association of HbA1c variability with renal disease (risk ratio 1.56 [95% CI 1.08–2.25], two studies), cardiovascular events (1.98 [1.39–2.82]), and retinopathy (2.11 [1.54–2.89]). Thirteen studies evaluated HbA1c variability among patients with type 2 diabetes. Higher HbA1c variability was associated with higher risk of renal disease (1.34 [1.15–1.57], two studies), macrovascular events (1.21 [1.06–1.38]), ulceration/gangrene (1.50 [1.06–2.12]), cardiovascular disease (1.27 [1.15–1.40]), and mortality (1.34 [1.18–1.53]). Most studies were retrospective with lack of adjustment for potential confounders, and inconsistency existed in the definition of HbA1c variability. CONCLUSIONS: HbA1c variability was positively associated with micro- and macrovascular complications and mortality independently of the HbA1c level and might play a future role in clinical risk assessment

Modelling Conditions and Health Care Processes in Electronic Health Records : An Application to Severe Mental Illness with the Clinical Practice Research Datalink

BACKGROUND: The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. METHODS: We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. RESULTS: We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. CONCLUSION: We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists

How to identify when a performance indicator has run its course

The official published version can be found at the link below.Increasing numbers of countries are using indicators to evaluate the quality of clinical care, with some linking payment to achievement. For performance frameworks to remain effective the indicators need to be regularly reviewed. The frameworks cannot cover all clinical areas, and achievement on chosen indicators will eventually reach a ceiling beyond which further improvement is not feasible. However, there has been little work on how to select indictors for replacement. The Department of Health decided in 2008 that it would regularly replace indicators in the national primary care pay for performance scheme, the Quality and Outcomes Framework, making a rigorous approach to removal a priority. We draw on our previous work on pay for performance and our current work advising the National Institute for Health and Clinical Excellence (NICE) on the Quality and Outcomes Framework to suggest what should be considered when planning to remove indicators from a clinical performance framework

Patient experience of access to primary care: identification of predictors in a national patient survey.

BACKGROUND: The 2007/8 GP Access Survey in England measured experience with five dimensions of access: getting through on the phone to a practice, getting an early appointment, getting an advance appointment, making an appointment with a particular doctor, and surgery opening hours. Our aim was to identify predictors of patient satisfaction and experience with access to English primary care. METHODS: 8,307 English general practices were included in the survey (of 8,403 identified). 4,922,080 patients were randomly selected and contacted by post and 1,999,523 usable questionnaires were returned, a response rate of 40.6%. We used multi-level logistic regressions to identify patient, practice and regional predictors of patient satisfaction and experience. RESULTS: After controlling for all other factors, younger people, and people of Asian ethnicity, working full time, or with long commuting times to work, reported the lowest levels of satisfaction and experience of access. For people in work, the ability to take time off work to visit the GP effectively eliminated the disadvantage in access. The ethnic mix of the local area had an impact on a patient's reported satisfaction and experience over and above the patient's own ethnic identity. However, area deprivation had only low associations with patient ratings. Responses from patients in small practices were more positive for all aspects of access with the exception of satisfaction with practice opening hours. Positive reports of access to care were associated with higher scores on the Quality and Outcomes Framework and with slightly lower rates of emergency admission. Respondents in London were the least satisfied and had the worst experiences on almost all dimensions of access. CONCLUSIONS: This study identifies a number of patient groups with lower satisfaction, and poorer experience, of gaining access to primary care. The finding that access is better in small practices is important given the increasing tendency for small practices to combine into larger units. Consideration needs to be given to ways of retaining these and other benefits of small practice size when primary care services are reconfigured. Differences between population groups (e.g. younger people, ethnic minorities) may be due to differences in actual care received or different response tendencies of different groups. Further analysis is needed to determine whether case-mix adjustment is required when comparing practices serving different populations.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischaemic heart disease: a cohort study with nested case-control analysis

Objective To conduct a fully independent and external validation of a research study based on one electronic health record database, using a different electronic database sampling the same population. Design Using the Clinical Practice Research Datalink (CPRD), we replicated a published investigation into the effects of statins in patients with ischaemic heart disease (IHD) by a different research team using QResearch. We replicated the original methods and analysed all-cause mortality using: (1) a cohort analysis and (2) a case-control analysis nested within the full cohort. Setting Electronic health record databases containing longitudinal patient consultation data from large numbers of general practices distributed throughout the UK. Participants CPRD data for 34 925 patients with IHD from 224 general practices, compared to previously published results from QResearch for 13 029 patients from 89 general practices. The study period was from January 1996 to December 2003. Results We successfully replicated the methods of the original study very closely. In a cohort analysis, risk of death was lower by 55% for patients on statins, compared with 53% for QResearch (adjusted HR 0.45, 95% CI 0.40 to 0.50; vs 0.47, 95% CI 0.41 to 0.53). In case-control analyses, patients on statins had a 31% lower odds of death, compared with 39% for QResearch (adjusted OR 0.69, 95% CI 0.63 to 0.75; vs OR 0.61, 95% CI 0.52 to 0.72). Results were also close for individual statins. Conclusions Database differences in population characteristics and in data definitions, recording, quality and completeness had a minimal impact on key statistical outputs. The results uphold the validity of research using CPRD and QResearch by providing independent evidence that both datasets produce very similar estimates of treatment effect, leading to the same clinical and policy decisions. Together with other non-independent replication studies, there is a nascent body of evidence for wider validity

rEHR: An R package for manipulating and analysing Electronic Health Record data

Research with structured Electronic Health Records (EHRs) is expanding as data becomes more accessible; analytic methods advance; and the scientific validity of such studies is increasingly accepted. However, data science methodology to enable the rapid searching/extraction, cleaning and analysis of these large, often complex, datasets is less well developed. In addition, commonly used software is inadequate, resulting in bottlenecks in research workflows and in obstacles to increased transparency and reproducibility of the research. Preparing a research-ready dataset from EHRs is a complex and time consuming task requiring substantial data science skills, even for simple designs. In addition, certain aspects of the workflow are computationally intensive, for example extraction of longitudinal data and matching controls to a large cohort, which may take days or even weeks to run using standard software. The rEHR package simplifies and accelerates the process of extracting ready-for-analysis datasets from EHR databases. It has a simple import function to a database backend that greatly accelerates data access times. A set of generic query functions allow users to extract data efficiently without needing detailed knowledge of SQL queries. Longitudinal data extractions can also be made in a single command, making use of parallel processing. The package also contains functions for cutting data by time-varying covariates, matching controls to cases, unit conversion and construction of clinical code lists. There are also functions to synthesise dummy EHR. The package has been tested with one for the largest primary care EHRs, the Clinical Practice Research Datalink (CPRD), but allows for a common interface to other EHRs. This simplified and accelerated work flow for EHR data extraction results in simpler, cleaner scripts that are more easily debugged, shared and reproduced