Completeness, agreement, and representativeness of ethnicity recording in the United Kingdom's Clinical Practice Research Datalink (CPRD) and linked Hospital Episode Statistics (HES).

BACKGROUND: This descriptive study assessed the completeness, agreement, and representativeness of ethnicity recording in the United Kingdom (UK) Clinical Practice Research Datalink (CPRD) primary care databases alone and, for those patients registered with a GP in England, when linked to secondary care data from Hospital Episode Statistics (HES). METHODS: Ethnicity records were assessed for all patients in the May 2021 builds of the CPRD GOLD and CPRD Aurum databases for all UK patients. In analyses of the UK, English data was from combined CPRD-HES, whereas data from Northern Ireland, Scotland, and Wales drew from CPRD only. The agreement of ethnicity records per patient was assessed within each dataset (CPRD GOLD, CPRD Aurum, and HES datasets) and between datasets at the highest level ethnicity categorisation ('Asian', 'black', 'mixed', 'white', 'other'). Representativeness was assessed by comparing the ethnic distributions at the highest-level categorisation of CPRD-HES to those from the Census 2011 across the UK's devolved administrations. Additionally, CPRD-HES was compared to the experimental ethnic distributions for England and Wales from the Office for National Statistics in 2019 (ONS2019) and the English ethnic distribution from May 2021 from NHS Digital's General Practice Extraction Service Data for Pandemic Planning and Research with HES data linkage (GDPPR-HES). RESULTS: In CPRD-HES, 81.7% of currently registered patients in the UK had ethnicity recorded in primary care. For patients with multiple ethnicity records, mismatched ethnicity within individual primary and secondary care datasets was < 10%. Of English patients with ethnicity recorded in both CPRD and HES, 93.3% of records matched at the highest-level categorisation; however, the level of agreement was markedly lower in the 'mixed' and 'other' ethnic groups. CPRD-HES was less proportionately 'white' compared to the UK Census 2011 (80.3% vs. 87.2%) and experimental ONS2019 data (80.4% vs. 84.3%). CPRD-HES was aligned with the ethnic distribution from GDPPR-HES ('white' 80.4% vs. 80.7%); however, with a smaller proportion classified as 'other' (1.1% vs. 2.8%). CONCLUSIONS: CPRD-HES has suitable representation of all ethnic categories with some overrepresentation of minority ethnic groups and a smaller proportion classified as 'other' compared to the UK general population from other data sources. CPRD-HES data is useful for studying health risks and outcomes in typically underrepresented groups.

The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England.

We estimated the frequency of non-specific influenza-associated clinical endpoints to inform the feasibility of pragmatic randomized controlled trials (RCT) assessing relative vaccine effectiveness (rVE). Hospitalization rates of respiratory, cardiovascular and diabetic events were estimated from Denmark and England's electronic databases and stratified by age, comorbidity and influenza vaccination status. We included a seasonal average of 4.5 million Danish and 7.2 million English individuals, 17 and 32% with comorbidities. Annually, approximately 1% of Danish and 0.5% of English individuals were hospitalized for selected events, ~50% of them respiratory. Hospitalization rates were 40-50-fold and 2-10-fold higher in those >50 years and with comorbidities, respectively. Our findings suggest that a pragmatic RCT using non-specific endpoints is feasible. However, for outcomes with rates <2.5%, it would require randomization of ~100,000 participants to have the power to detect a rVE difference of ~13%. Targeting selected groups (older adults, those with comorbidities) where frequency of events is high would improve trial efficiency.

Use of prescribing safety quality improvement reports in UK general practices: a qualitative assessment.

BACKGROUND: Quality improvement (QI) initiatives are increasingly used to improve the quality of care and reduce prescribing errors. The Royal College of General Practitioners (RCGP) and Clinical Practice Research Datalink (CPRD) QI initiative uses routinely collected electronic primary care data to provide bespoke practice-level reports on prescribing safety. The aim of this study was to explore how the QI reports were used, barriers and facilitators to use, long-term culture change and perceived impact on patient care and practices systems as a result of receiving the reports. METHODS: A qualitative study using purposive sampling of practices contributing to the CPRD, semi-structured interviews and inductive thematic analysis. We interviewed general practitioners, pharmacists, practice managers and research nurses. RESULTS: We conducted 18 interviews, and organised themes summarising the use of QI reports in practice: receiving the report, facilitators and barriers to acting upon the reports, acting upon the report, and how the reports contribute to a quality culture. Effective dissemination of reports, and a positive attitude to audit and the perceived relevance of the clinical topic facilitated use. Lack of time and failure to see or act upon the reports meant they were not used. Factors influencing use of the reports included the structure of the report, ease of identifying cases, and perceptions about coding accuracy. GPs and pharmacists used the reports to conduct case reviews and directly contact patients to discuss unsafe prescribing and patient medication preferences. Finally, the reports contributed to the development of a quality culture within practices through promoting audit activity and acting as a reminder of good prescribing behaviours, promoting future patient safety initiatives, contributing to continuing professional development and improving local networks. CONCLUSIONS: This study found the reports facilitated individual case review leading to an enhanced sense of quality culture in practices where they were utilised. Our findings demonstrate that the reports were generally considered useful and have been used to support patient safety and clinical practice in specific cases.

Evaluating the Effectiveness of an Additional Risk Minimization Measure to Reduce the Risk of Prescribing Mirabegron to Patients with Severe Uncontrolled Hypertension in Four European Countries.

BACKGROUND: Mirabegron, indicated for the treatment of overactive bladder, is contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg). In September 2015, a Direct Healthcare Professional Communication (DHPC) letter was disseminated as an additional risk minimisation measure. PURPOSE: To assess the effectiveness of the DHPC in reducing the proportions of patients with severe or non-severe uncontrolled hypertension at mirabegron initiation. METHODS: An observational multi-database cohort study was undertaken using routinely collected healthcare data (December 2012-December 2016) from the PHARMO Database Network (Netherlands), SIDIAP database (Spain), CPRD (United Kingdom, UK) and national healthcare registers and electronic medical records from Finland. DHPC effectiveness was evaluated using interrupted time series analyses comparing trends and changes in monthly proportions of severe or non-severe uncontrolled hypertensive mirabegron initiations relative to the timing of the DHPC dissemination. RESULTS: The study population comprised 52,078 patients. Prior to DHPC dissemination, across the four databases, 0.3-1.3% had severe uncontrolled hypertension. Estimated absolute changes (EAC) in proportions of severe uncontrolled hypertension post-DHPC indicated a tendency towards a lower proportion in the Netherlands (EAC -0.36%, p=0.053), unchanged proportions in Spain and the UK and a higher proportion in Finland (EAC +0.73%, p=0.016). For non-severe uncontrolled hypertension (13-16% pre-DHPC), post-DHPC proportions tended to be lower in the Netherlands (EAC -2.02%, p=0.038) and Spain (EAC -1.04%, p=0.071), and unchanged in the UK and Finland. CONCLUSION: Severe uncontrolled hypertension prior to mirabegron initiation was uncommon in these four European countries even before DHPC dissemination. This suggests that other risk minimisation communications (prior to the DHPC dissemination) had worked adequately with respect to minimising mirabegron use among patients with severe uncontrolled hypertension. No strong and consistent evidence of further risk minimisation after the DHPC dissemination was observed in this study.

Quality improvement of prescribing safety: a pilot study in primary care using UK electronic health records.

BACKGROUND: Quality improvement (QI) is a priority for general practice, and GPs are expected to participate in and provide evidence of QI activity. There is growing interest in harnessing the potential of electronic health records (EHR) to improve patient care by supporting practices to find cases that could benefit from a medicines review. AIM: To develop scalable and reproducible prescribing safety reports using patient-level EHR data. DESIGN AND SETTING: UK general practices that contribute de-identified patient data to the Clinical Practice Research Datalink (CPRD). METHOD: A scoping phase used stakeholder consultations to identify primary care QI needs and potential indicators. QI reports containing real data were sent to 12 pilot practices that used Vision GP software and had expressed interest. The scale-up phase involved automating production and distribution of reports to all contributing practices that used both Vision and EMIS software systems. Benchmarking reports with patient-level case review lists for two prescribing safety indicators were sent to 457 practices in December 2017 following the initial scale-up (Figure 2). RESULTS: Two indicators were selected from the Royal College of General Practitioners Patient Safety Toolkit following stakeholder consultations for the pilot phase involving 12 GP practices. Pilot phase interviews showed that reports were used to review individual patient care, implement wider QI actions in the practice, and for appraisal and revalidation. CONCLUSION: Electronic health record data can be used to provide standardised, reproducible reports that can be delivered at scale with minimal resource requirements. These can be used in a national QI initiative that impacts directly on patient care.

Antidepressant utilisation and incidence of weight gain during 10 years' follow-up: population based cohort study.

OBJECTIVE: To evaluate the long term association between antidepressant prescribing and body weight. DESIGN: Population based cohort study. SETTING: General practices contributing to the UK Clinical Practice Research Datalink, 2004-14. PARTICIPANTS: 136 762 men and 157 957 women with three or more records for body mass index (BMI). MAIN OUTCOME MEASURES: The main outcomes were antidepressant prescribing, incidence of ≥5% increase in body weight, and transition to overweight or obesity. Adjusted rate ratios were estimated from a Poisson model adjusting for age, sex, depression recording, comorbidity, coprescribing of antiepileptics or antipsychotics, deprivation, smoking, and advice on diet. RESULTS: In the year of study entry, 17 803 (13.0%) men and 35 307 (22.4%) women with a mean age of 51.5 years (SD 16.6 years) were prescribed antidepressants. During 1 836 452 person years of follow-up, the incidence of new episodes of ≥5 weight gain in participants not prescribed antidepressants was 8.1 per 100 person years and in participants prescribed antidepressants was 11.2 per 100 person years (adjusted rate ratio 1.21, 95% confidence interval 1.19 to 1.22, P<0.001). The risk of weight gain remained increased during at least six years of follow-up. In the second year of treatment the number of participants treated with antidepressants for one year for one additional episode of ≥5% weight gain was 27 (95% confidence interval 25 to 29). In people who were initially of normal weight, the adjusted rate ratio for transition to overweight or obesity was 1.29 (1.25 to 1.34); in people who were initially overweight, the adjusted rate ratio for transition to obesity was 1.29 (1.25 to 1.33). Associations may not be causal, and residual confounding might contribute to overestimation of associations. CONCLUSION: Widespread utilisation of antidepressants may be contributing to long term increased risk of weight gain at population level. The potential for weight gain should be considered when antidepressant treatment is indicated.

Socioeconomic inequality in morbid obesity with body mass index more than 40 kg/m2 in the United States and England.

INTRODUCTION: This study evaluated socioeconomic inequality in morbid obesity (body mass index, BMI ≥40 kg/m2) through an analysis of population health survey data in the United States (US) and England (UK). METHODS: We analysed data for the National Health and Nutrition Examination Survey and the Health Survey for England for 2011 to 2014. Age-adjusted odds ratios (AOR) were used to evaluate income- and education-inequality. RESULTS: There were 26,898 eligible UK and 10,628 US participants. Morbid obesity was more frequent in women than men, and higher in the US than the UK (men: US, 4.8%; UK, 1.7%; women US, 9.6%; UK, 3.7%). In the UK, morbid obesity showed graded income-inequality in both genders (AOR, for lowest income quintile: men, 1.83, 95% confidence interval 1.16 to 2.88; women, 2.18, 1.55 to 3.07), as well as education-inequality (AOR for no school qualifications, men 2.57, 1.64 to 4.02; women, 2.18, 1.55 to 3.07). In the US, morbid obesity showed a consistent gradient only for income in women (AOR for lowest income quintile 1.97, 1.19 to 3.25). When compared with all other US groups, having college education (AOR, men, 0.56, 0.29 to 1.08; women, 0.36, 0.22 to 0.60) or household income ≥$75 000 (AOR, men 0.52, 0.27 to 0.98; women, 0.51, 0.33 to 0.80) appeared to protect against morbid obesity. CONCLUSIONS: Morbid obesity is associated with lower socioeconomic status in men and women in the UK. In the US, morbid obesity was twice as prevalent, but less strongly associated with socioeconomic status, suggesting that morbid obesity may now have spread to all but the highest socioeconomic groups.

Changing Epidemiology of Bariatric Surgery in the UK: Cohort Study Using Primary Care Electronic Health Records.

BACKGROUND: This study aimed to use primary care electronic health records to evaluate the epidemiology of bariatric surgery in the UK. METHODS: A cohort comprising all obese patients with a bariatric surgical procedure was drawn from the Clinical Practice Research Datalink (CPRD). Rates of bariatric surgery were estimated using the registered CPRD population as denominator. RESULTS: There were 3039 adult obese patients with first bariatric surgery procedures between 2002 and 2014, including laparoscopic adjustable gastric banding (LAGB), 1297; gastric bypass (GBP), 1265; and sleeve gastrectomy (SG), 477. Annual procedures increased from one in 2002 to a maximum of 525 in 2010. Intervention rates were greatest among those aged 35-54, with a peak of 37 procedures per 100,000 population per year in women and 10 per 100,000 per year in men. The mean age and body mass index of participants increased, as did the proportion of men and proportion with diabetes. Between 2002 and 2006, LAGB accounted for >90 % of procedures; in 2014, GBP accounted for 52 % and SG 26 %. Among patients initially receiving LAGB, the rate of band removal was 1.6 (95 % confidence interval 1.3-2.0) per 100 patient years; the rate of a second procedure of a different type was 1.2 (0.9-1.5) per 100 patient years. CONCLUSIONS: Numbers of bariatric surgical procedures have increased with increasing use of GBP and SG. Rates of bariatric surgery per 100,000 population remain low and provide evidence of limited access to bariatric surgical procedures in relation to need.

Access to weight reduction interventions for overweight and obese patients in UK primary care: population-based cohort study.

OBJECTIVES: To investigate access to weight management interventions for overweight and obese patients in primary care. SETTING: UK primary care electronic health records. PARTICIPANTS: A cohort of 91 413 overweight and obese patients aged 30-100 years was sampled from the Clinical Practice Research Datalink (CPRD). Patients with body mass index (BMI) values ≥25 kg/m(2) recorded between 2005 and 2012 were included. BMI values were categorised using WHO criteria. INTERVENTIONS: Interventions for body weight management, including advice, referrals and prescription of antiobesity drugs, were evaluated. PRIMARY AND SECONDARY OUTCOME MEASURES: The rate of body weight management interventions and time to intervention were the main outcomes. RESULTS: Data were analysed for 91 413 patients, mean age 56 years, including 55 094 (60%) overweight and 36 319 (40%) obese, including 4099 (5%) with morbid obesity. During the study period, 90% of overweight patients had no weight management intervention recorded. Intervention was more frequent among obese patients, but 59% of patients with morbid obesity had no intervention recorded. Rates of intervention increased with BMI category. In morbid obesity, rates of intervention per 1000 patient years were: advice, 60.2 (95% CI 51.8 to 70.4); referral, 75.7 (95% CI 69.5 to 82.6) and antiobesity drugs 89.9 (95% CI 85.0 to 95.2). Weight management interventions were more often accessed by women, older patients, those with comorbidity and those in deprivation. Follow-up of body weight subsequent to interventions was infrequent. CONCLUSIONS: Limited evidence of weight management interventions in primary care electronic health records may result from poor recording of advice given, but may indicate a lack of patient access to appropriate body weight management interventions in primary care.

Effectiveness of behavioural weight loss interventions delivered in a primary care setting: a systematic review and meta-analysis.

BACKGROUND: Overweight and obesity have negative health effects. Primary care clinicians are best placed to intervene in weight management. Previous reviews of weight loss interventions have included studies from specialist settings. The aim of this review was to estimate the effect of behavioural interventions delivered in primary care on body weight in overweight and obese adults. METHODS: The review included randomized controlled trials (RCTs) of behavioural interventions in obese or overweight adult participants in a primary care setting, with weight loss as the primary outcome, and a minimum of 12 months of follow-up. A systematic search strategy was implemented in Medline, Embase, Web of Science and the Cochrane Central Registry of Controlled Trials. Risk of bias was assessed using the Cochrane Risk of Bias tool and behavioural science components of interventions were evaluated. Data relating to weight loss in kilograms were extracted, and the results combined using meta-analysis. RESULTS: Fifteen RCTs, with 4539 participants randomized, were selected for inclusion. The studies were heterogeneous with respect to inclusion criteria and type of intervention. Few studies reported interventions informed by behavioural science theory. Pooled results from meta-analysis indicated a mean weight loss of -1.36 kg (-2.10 to -0.63, P < 0.0001) at 12 months, and -1.23 kg (-2.28 to -0.18, P = 0.002) at 24 months. CONCLUSION: Behavioural weight loss interventions in primary care yield very small reductions in body weight, which are unlikely to be clinically significant. More effective management strategies are needed for the treatment of overweight and obesity.

Impact of body mass index on prevalence of multimorbidity in primary care: cohort study.

BACKGROUND: Multimorbidity is the co-occurrence of long-term conditions. Obesity is associated with an increased risk of long-term conditions including type 2 diabetes and depression. OBJECTIVE: To quantify the association between body mass index (BMI) category and multimorbidity in a large cohort registered in primary care. METHODS: The sample comprised primary care electronic health records of adults aged ≥30 years, sampled from the Clinical Practice Research Datalink between 2005 and 2011. Multimorbidity was defined as the co-occurrence of ≥2 of 11 conditions affecting seven organ systems. Age- and sex-standardized prevalence of multimorbidity was estimated by BMI category. Adjusted odds ratios associating BMI with additional morbidity were estimated adjusting for socioeconomic deprivation and smoking. RESULTS: The sample comprised 300 006 adults. After excluding participants with BMI never recorded, data were analysed for 223 089 (74%) contributing 1 374 109 person-years. In normal weight men, the standardized prevalence of multimorbidity was 23%, rising to 27% in overweight, 33% in category I obesity, 38% in category II and 44% in category III obesity. In women, the corresponding values were 28%, 34%, 41%, 45% and 51%. In category III obesity, the adjusted odds, relative to normal BMI, were 2.24 (2.13-2.36) for a first condition; 2.63 (2.51-2.76) for a second condition and 3.09 (2.92-3.28) for three or more conditions. In a cross-sectional analysis, 32% of multimorbidity was attributable to overweight and obesity. CONCLUSIONS: Multiple morbidity is highly associated with increasing BMI category and obesity, highlighting the potential for targeted primary and secondary prevention interventions in primary care.

Validity of smoking prevalence estimates from primary care electronic health records compared with national population survey data for England, 2007 to 2011.

PURPOSE: Primary care electronic health records (EHRs) are increasingly used as a resource for epidemiological research. Cigarette smoking is an important variable in many epidemiological studies. We evaluated the validity of smoking records in primary care EHRs by comparing estimates for smoking prevalence from primary care EHRs with national health survey data. METHODS: Data were analysed for adults over 30 years of age from the Clinical Practice Research Datalink (CPRD) in comparison with data from the Health Survey for England between 2007 and 2011. Electronic health records in the CPRD were searched for records of smoking status and smoking cessation treatment. Annual age- and sex-standardised prevalence of current-, non- and former smoking were calculated, and compared with equivalent data from the Health Survey for England (HSE). RESULTS: The difference between estimates of current smoking in CPRD and HSE was generally <1% from 2007 to 2011. In 2011, the prevalence of current smoking in men was: CPRD 24.3%, HSE 24.2%. The mean difference was 0.1% (95% confidence interval −1.5 to 1.7%). In women, current smoking prevalence was CPRD 20.3%, HSE 19.0%; mean difference 1.3% (0.0 to 2.6%). Estimates for former smoking were lower in CPRD than HSE for men (CPRD 26.7%, HSE 31.3%) and women (CPRD 22.9%, HSE 25.0%). CONCLUSIONS: Prevalence estimates for current smoking, and non-smoking, from primary care EHRs are similar to those from nationally representative surveys, but former smoking may be under-recorded.

Overtreatment of COPD with inhaled corticosteroids--implications for safety and costs: cross-sectional observational study.

INTRODUCTION: Combined inhaled long-acting beta-agonists and corticosteroids (LABA+ICS) are costly. They are recommended in severe or very severe chronic obstructive pulmonary disease (COPD). They should not be prescribed in mild or moderate disease. In COPD ICS are associated with side-effects including risk of pneumonia. We quantified appropriateness of prescribing and examined the risks and costs associated with overuse. METHODS: Data were extracted from the electronic and paper records of 41 London general practices (population 310,775) including spirometry, medications and exacerbations. We classified severity, assessed appropriateness of prescribing using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 2009, and performed a sensitivity analysis using the broader recommendations of the 2011 revision. RESULTS: 3537 patients had a diagnosis of COPD. Spirometry was recorded for 2458(69%). 709(29%) did not meet GOLD criteria. 1749(49%) with confirmed COPD were analysed: 8.6% under-treated, 38% over-treated. Over-prescription of ICS in GOLD stage I or II (n=403, 38%) and in GOLD III or IV without exacerbations (n=231, 33.6%) was common. An estimated 12 cases (95%CI 7-19) annually of serious pneumonia were likely among 897 inappropriately treated. 535 cases of overtreatment involved LABA+ICS with a mean per patient cost of £553.56/year (€650.03). Using the broader indications for ICS in the 2011 revised GOLD guideline 25% were still classified as over-treated. The estimated risk of 15 cases of pneumonia (95%CI 8-22) in 1074 patients currently receiving ICS would rise by 20% to 18 (95%CI 9.8-26.7) in 1305 patients prescribed ICS if all with GOLD grade 3 and 4 received LABA+ICS. CONCLUSION: Over-prescription of ICS in confirmed COPD was widespread with considerable potential for harm. In COPD where treatment is often escalated in the hope of easing the burden of disease clinicians should consider both the risks and benefits of treatment and the costs where the benefits are unproven.

Epidemiology of clinical body mass index recording in an obese population in primary care: a cohort study.

BACKGROUND: Protecting and promoting the health of obese people is an important public health concern. This study evaluated the recording of body mass index and medical diagnostic codes for obesity in obese patients in UK primary care. METHODS: A cohort study was implemented in the UK General Practice Research Database. Subjects were aged 18-100 years and were diagnosed with obesity between 1997 and 2007. The frequency of obesity monitoring was evaluated. RESULTS: There were 67 000 obese patients at 127 family practices. The proportion of obese patients with no annual body mass index (BMI) record reached 65% of men and 63% of women in 2000, declining to 55 and 48% in 2009. Medical diagnostic codes for obesity were infrequently recorded. The mean BMI of obese patients increased to 35.5 kg/m(2) [95% confidence interval (CI): 35.4-35.7] in men and 37.0 kg/m(2) (95% CI: 36.9-37.1) in women by 2009. In 2009, 37% of obese men with BMI records, and 39% of women, showed a BMI increase of ≥1 kg/m(2) since the previous reading. CONCLUSIONS: Obese patients do not have BMI values recorded regularly. The mean BMI of obese patients, and the proportion gaining weight over time, is increasing. Improved strategies for monitoring and managing obesity are required.