Predicting risk of endometrial cancer in asymptomatic women (PRECISION): Model development and external validation.

OBJECTIVES: Develop an endometrial cancer risk prediction model and externally validate it for UK primary care use. DESIGN: Cohort study. SETTING: The UK Biobank was used for model development and a linked primary (Clinical Practice Research Datalink, CPRD) and secondary care (HES), mortality (ONS) and cancer register (NRCAS) dataset was used for external validation. POPULATION: Women aged 45-60 years with no history of endometrial cancer or hysterectomy. METHODS: Model development was performed using a flexible parametric survival model and stepwise backward selection aiming to minimise the Akaike information criterion. Model performance on external validation was assessed through flexible calibration plots, calculation of the expected to observed ratio and C-statistic and decision curve analysis. MAIN OUTCOME MEASURES: Endometrial cancer diagnosis within 1-10 years of the index date. RESULTS: Model development included 222 031 women (902 incident endometrial cancer cases) and external validation 3 094 371 women (8585 endometrial cancer cases). The final model (with equation provided) incorporated age, body mass index, waist circumference, age at menarche, menopause and last birth, hormone replacement, tamoxifen and oral contraceptive pill use, type 2 diabetes, smoking and family history of bowel cancer. It was well calibrated on external validation (calibration slope 1.14, 95% confidence interval [CI] 1.11-1.17, E/O 1.03, 95% CI 1.01-1.05), with moderate/good discrimination (C-statistic 0.70, 95% CI 0.69-0.70) and had improved net benefit compared with previously developed models. CONCLUSIONS: The Predicting risk of endometrial cancer in asymptomatic women model (PRECISION), using easily measurable anthropometric, reproductive, personal and family history, accurately quantifies a woman's 10-year risk of endometrial cancer. Its use could determine eligibility for primary endometrial cancer prevention trials and for targeted resource allocation in UK general practices.

Sex differences in the etiology and burden of heart failure across country income level: analysis of 204 countries and territories 1990-2019.

BACKGROUND: Heart failure (HF) is a global epidemic. OBJECTIVE: To assess global sex differences in HF epidemiology across country income levels. METHODS AND RESULTS: Using Global Burden of Disease (GBD) data from 204 countries and territories 1990-2019, we assessed sex differences in HF prevalence, etiology, morbidity, and temporal trends across country sociodemographic index or gross national income. We derived age-standardized rates. Of 56.2 million (95% uncertainty interval [UI] 46.4-67.8 million) people with HF in 2019, 50.3% were females and 69.2% lived in low- and middle-income countries; age-standardized prevalence was greater in males and in high-income countries. Ischaemic and hypertensive heart disease were top causes of HF in males and females, respectively. There were 5.1 million (95% UI 3.3-7.3 million) years lived with disability, distributed equally between sexes. Between 1990 and 2019, there was an increase in HF cases, but a decrease in age-standardized rates per 100 000 in males (9.1%, from 864.2 to 785.7) and females (5.8%, from 686.0 to 646.1). High-income regions experienced a 16.0% decrease in age-standardized rates (from 877.5 to 736.8), while low-income regions experienced a 3.9% increase (from 612.1 to 636.0), largely consistent across sexes. There was a temporal increase in age-standardized HF from hypertensive, rheumatic, and calcific aortic valvular heart disease, and a decrease from ischaemic heart disease, with regional and sex differences. CONCLUSION: Age-standardized HF rates have decreased over time, with larger decreases in males than females; and with large decreases in high-income and small increases in low-income regions. Sex and regional differences offer targets for intervention.

Impact of COVID-19 on percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: The objective of the study was to identify any changes in primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) in England by analysing procedural numbers, clinical characteristics and patient outcomes during the COVID-19 pandemic. METHODS: We conducted a retrospective cohort study of patients who underwent PCI in England between January 2017 and April 2020 in the British Cardiovascular Intervention Society-National Institute of Cardiovascular Outcomes Research database. Analysis was restricted to 44 hospitals that reported contemporaneous activity on PCI. Only patients with primary PCI for STEMI were included in the analysis. RESULTS: A total of 34 127 patients with STEMI (primary PCI 33 938, facilitated PCI 108, rescue PCI 81) were included in the study. There was a decline in the number of procedures by 43% (n=497) in April 2020 compared with the average monthly procedures between 2017 and 2019 (n=865). For all patients, the median time from symptom to hospital showed increased after the lockdown (150 (99-270) vs 135 (89-250) min, p=0.004) and a longer door-to-balloon time after the lockdown (48 (21-112) vs 37 (16-94) min, p<0.001). The in-hospital mortality rate was 4.8% before the lockdown and 3.5% after the lockdown (p=0.12). Following adjustment for baseline characteristics, no differences were observed for in-hospital death (OR 0.87, 95% CI 0.45 to 1.68, p=0.67) and major adverse cardiovascular events (OR 0.71, 95% CI 0.39 to 1.32, p=0.28). CONCLUSIONS: Following the lockdown in England, we observed a decline in primary PCI procedures for STEMI and increases in overall symptom-to-hospital and door-to-balloon time for patients with STEMI. Restructuring health services during COVID-19 has not adversely influenced in-hospital outcomes.

Clinical Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusion in Native Coronary Arteries vs Saphenous Vein Grafts.

BACKGROUND: There are limited data comparing outcomes of patients with previous coronary artery bypass grafting (CABG) presenting with stable angina who undergo percutaneous coronary intervention (PCI) to either a saphenous vein grafts (SVG) or a chronic total occlusion (CTO) in the native coronary arteries. We compared clinical characteristics and outcomes of these two groups in a national cohort. METHODS AND RESULTS: We formed a longitudinal cohort (2007-2014; n = 11,132) of patients who underwent SVG-PCI (group 1; n = 8619) or CTO-PCI in native arteries (group 2; n = 2513) in the British Cardiovascular Intervention Society (BCIS) database. Median age was 68 years in both groups, but patients in group 2 were less likely to be female, had a higher prevalence of diabetes mellitus, hypertension, hypercholesterolemia, and previous myocardial infarction, as well as worsened angina and breathlessness, but history of prior stroke, renal diseases, and the presence of left ventricular systolic dysfunction were similar to group 1. Following multivariable analysis, no significant difference in mortality was observed during index hospital admission (odds ratio [OR], 1.70; 95% confidence interval [CI], 0.63-4.58; P=.29), at 30 days (OR, 1.81; 95% CI, 0.99-3.3; P=.05), and 1 year (OR, 1.11; 95% CI, 0.85-1.44; P=.43), nor was a significant difference found in in-hospital MACE rates (OR, 1.36; 95% CI, 0.85-2.19; P=.19). However, CTO-PCI was associated with more procedural complications (OR, 2.88; 95% CI, 2.38-3.47; P<.01) and vessel perforation (OR, 4.82; 95% CI, 2.80-8.28; P<.01) as compared with the SVG-PCI group. Risk of target-vessel revascularization at 1 year was similar (SVG-PCI 5.6% vs CTO-PCI 6.9%; P=.08). CONCLUSION: In this national cohort, CTO-PCI was performed in higher-risk patients, and was associated with more procedural complications but similar short-term or long-term mortality and in-hospital MACE.

Coronary perforation complicating percutaneous coronary intervention in patients presenting with an acute coronary syndrome: An analysis of 1013 perforation cases from the British Cardiovascular Intervention Society database.

BACKGROUND: The evidence base for coronary perforation occurring during percutaneous coronary intervention in patients presenting with an acute coronary syndrome (ACS-PCI) is limited and the specific role of acute pharmacology in its clinical presentation unclear. METHODS AND RESULTS: Using the BCIS PCI database, data were analysed on all ACS-PCI procedures performed in England and Wales between 2007 and 2014. Multiple regressions were used to identify predictors of coronary perforation and its association with outcomes. Propensity score matching was used to evaluate the association between differing P2Y12 inhibitors or glycoprotein inhibitors (GPI) and CP. During 270,329 ACS-PCI procedures, 1013 coronary perforations were recorded (0.37%) with a stable annual incidence. In multiple regression analysis, covariates associated with increased frequency of coronary perforation included age, female gender, CTO intervention, number and length of stents used, and rotational atherectomy use, whilst differing P2Y12 inhibitors were not predictive. Using propensity score matching, use of a GPI was independently associated with tamponade (OR 1.50, [1.08-2.06], p = 0.014). The adjusted odds ratios for all clinical outcomes were adversely affected by coronary perforation. CONCLUSIONS: Coronary perforation is an infrequent event during ACS-PCI but is closely associated with adverse clinical outcomes. GPI use was associated with higher rates of tamponade.

Timing and Causes of Unplanned Readmissions After Percutaneous Coronary Intervention: Insights From the Nationwide Readmission Database.

OBJECTIVES: The aim of this study was to describe the rates and causes of unplanned readmissions at different time periods following percutaneous coronary intervention (PCI). BACKGROUND: The rates and causes of readmission at different time periods after PCI remain incompletely elucidated. METHODS: Patients undergoing PCI between 2010 and 2014 in the U.S. Nationwide Readmission Database were evaluated for the rates, causes, predictors, and costs of unplanned readmission between 0 and 7 days, 8 and 30 days, 31 and 90 days, and 91 and 180 days after index discharge. RESULTS: This analysis included 2,412,000 patients; 2.5% were readmitted between 0 and 7 days, 7.6% between 8 and 30 days, 8.9% between 31 and 90 days, and 8.0% between 91 and 180 days (cumulative rates 2.5%, 9.9%, 18.0%, and 24.8%, respectively). The majority of readmissions during each time period were due to noncardiac causes (53.1% to 59.6%). Nonspecific chest pain was the most common identifiable noncardiac cause for readmission during each time period (14.2% to 22.7% of noncardiac readmissions). Coronary artery disease including angina was the most common cardiac cause for readmission during each time period (37.4% to 39.3% of cardiac readmissions). The second most common cardiac cause for readmission was acute myocardial infarction between 0 and 7 days (27.6% of cardiac readmissions) and heart failure during all subsequent time periods (22.2% to 23.7% of cardiac readmissions). CONCLUSIONS: Approximately 25% of patients following PCI have unplanned readmissions within 6 months. Causes of readmission depend on the timing at which they are assessed, with noncardiovascular causes becoming more important at longer time points.

Term sets: A transparent and reproducible representation of clinical code sets.

OBJECTIVE: Clinical code sets are vital to research using routinely-collected electronic healthcare data. Existing code set engineering methods pose significant limitations when considering reproducible research. To improve the transparency and reusability of research, these code sets must abide by FAIR principles; this is not currently happening. We propose 'term sets', an equivalent alternative to code sets that are findable, accessible, interoperable and reusable. MATERIALS AND METHODS: We describe a new code set representation, consisting of natural language inclusion and exclusion terms (term sets), and explain its relationship to code sets. We formally prove that any code set has a corresponding term set. We demonstrate utility by searching for recently published code sets, representing them as term sets, and reporting on the number of inclusion and exclusion terms compared with the size of the code set. RESULTS: Thirty-one code sets from 20 papers covering diverse disease domains were converted into term sets. The term sets were on average 74% the size of their equivalent original code set. Four term sets were larger due to deficiencies in the original code sets. DISCUSSION: Term sets can concisely represent any code set. This may reduce barriers for examining and reusing code sets, which may accelerate research using healthcare databases. We have developed open-source software that supports researchers using term sets. CONCLUSION: Term sets are independent of clinical code terminologies and therefore: enable reproducible research; are resistant to terminology changes; and are less error-prone as they are shorter than the equivalent code set.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

BACKGROUND: Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. METHODS/DESIGN: The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. DISCUSSION: The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. TRIAL REGISTRATION: Trial registration reference: ISRCTN45433299.

Combining multiple indicators of clinical quality: an evaluation of different analytic approaches.

OBJECTIVE: To compare different methods of combining quality indicators scores to produce composite scores that summarize the overall performance of health care providers. METHODS: Five methods for computing a composite quality score were compared: the "All-or-None," the "70% Standard," the "Overall Percentage," the "Indicator Average," and the "Patient Average." The first 2 "criterion-referenced" methods assess the degree to which a provider has reached a threshold for quality of care for each patient (100% or 70%). The remaining "absolute score" methods produce scores representing the proportion of required care successfully provided. Each method was applied to 2 quality indicator datasets, derived from audits of UK family practitioner records. Dataset A included quality indicator data for 1178 patients from 16 family practices covering 23 acute, chronic, and preventative conditions. Dataset B included data on 3285 patients from 60 family practices, covering 3 chronic conditions. RESULTS: The results varied considerably depending on the method of aggregation used, resulting in substantial differences in how providers scored. The results also varied considerably for the 2 datasets. There was more agreement between methods for dataset B, but for dataset A 6 of the 16 practices moved between the top and bottom quartiles depending upon the method used. CONCLUSIONS: Different methods of computing composite quality scores can lead to different conclusions being drawn about both relative and absolute quality among health care providers. Different methods are suited to different types of application. The main advantages and disadvantages of each method are described and discussed.