Routine care for chronic disease is an ongoing major challenge. We aimed to evaluate the global impact of COVID-19 on routine care for chronic diseases. An online survey was posted 31 March to 23 ...April 2020 targeted at healthcare professionals. 202 from 47 countries responded. Most reported change in routine care to virtual communication. Diabetes, chronic obstructive pulmonary disease, and hypertension were the most impacted conditions due to reduction in access to care. 80% reported the mental health of their patients worsened during COVID-19. It is important routine care continues in spite of the pandemic, to avoid a rise in non-COVID-19-related morbidity and mortality.
External comparator (EC) studies are increasingly being used to generate evidence that supports the evaluation of emerging pharmacological treatments for regulatory and health technology assessment ...(HTA) purposes. However, the reliability of evidence generated from EC studies can vary. In this paper, we outline how an existing framework for causal inference, the target trial emulation (TTE) framework, can be appropriately applied to improve the design and analysis of EC studies. Applying the TTE framework involves specifying the protocol of an ideal target trial which would answer the causal question of interest, then emulating its key elements under real-world (RW) settings. We describe each component of the original TTE framework and explain how it can be applied to EC studies, supplemented with practical recommendations. We also highlight special considerations and limitations in applying the TTE framework to EC studies. We describe how the TTE framework can be applied to improve the clarity, transparency, and reliability of evidence generated from EC studies.
Aims/Introduction
The aim of this study was to examine ethnicity‐specific associations between type 2 diabetes mellitus and the risk of a cardiovascular disease (CVD) event as well as risk of ...specific CVD phenotypes in England.
Methods
We obtained data from the Clinical Practice Research Datalink for adults with and without type 2 diabetes mellitus diagnosed 2000–2006. The outcome was the first CVD event during 2007–2017 and the following components: aortic aneurysm, cerebrovascular accidents, heart failure, myocardial infarction, peripheral vascular disease and other CVD‐related conditions. Flexible parametric survival models were used to estimate ethnicity‐specific adjusted hazard ratios.
Results
A total of 734,543 people with and without type 2 diabetes mellitus (29,847; 4.1%) were included; most were of white ethnicity (93.0% with and 92.3% without type 2 diabetes mellitus) followed by South Asian (3.2 and 4.6%). During a median follow‐up period of 11.0 years, 67,218 events occurred (6,156 in individuals with type 2 diabetes mellitus). Type 2 diabetes mellitus was associated with a small increase in CVD events (adjusted hazard ratio 1.06, 95% confidence interval 1.02–1.09) in individuals of white ethnicity; whereas the adjusted hazard ratios were considerably higher in individuals of South Asian ethnicity (1.28, 95% confidence interval 1.09–1.51), primarily due to an increased risk of myocardial infarction (1.53, 95% confidence interval 1.08–2.18).
Conclusions
Despite universal access to healthcare, there are large disparities in CVD outcomes in people with and without type 2 diabetes mellitus. Other non‐traditional risk factors might play a role in the higher CVD risk associated with type 2 diabetes mellitus in individuals of South Asian ethnicity.
Despite universal access to healthcare, there are large ethnic disparities in cardiovascular disease outcomes in people with and without type 2 diabetes mellitus. Type 2 diabetes mellitus was associated with a small increase in cardiovascular disease events (adjusted hazard ratio 1.06, 95% confidence interval 1.02–1.09) in individuals of white ethnicity; whereas the adjusted hazard ratio was considerably higher in individuals of South Asian ethnicity (1.28, 95% confidence interval 1.09–1.51), primarily due to an increased risk of myocardial infarction (adjusted hazard ratio 1.53, 95% confidence interval 1.08–2.18).
Abstract
Background
Worldwide, high systolic blood pressure is the leading risk factor for deaths and disability-adjusted life-years but has been historically under-detected. This study aimed to ...quantify differences between estimated and practice-detected prevalences of hypertension across English general practices, and to determine how variations in detected prevalence could be explained by population-level and service-level factors.
Methods
Descriptive statistics, pair wise correlations between the independent variables and a multivariable regression analysis were undertaken. In the regression model, the outcome was detected hypertension prevalence, adjusted for estimated prevalence, person-related and disease-related determinants of illness and characteristics of general practices.
Results
Detected prevalence was substantially lower than estimated prevalence (mean difference 16.23%; standard deviation 2.88%). Higher detected prevalence was associated with increased deprivation, increased non-white ethnicity and urban location. Lower detected prevalence was associated with larger list sizes, more general practitioners and being located in the South outside London. The final multivariable model’s adjusted R2 value was 0.75.
Conclusions
Substantial under-detection of hypertension is widespread across England. Independent of estimated prevalence, factors associated with greater morbidity and population density predicted higher detected prevalence. Identifying patients with undetected hypertension and coordinating care for these patients will require further resources and logistical support in community settings.
ObjectiveUsing primary care data, develop and validate sex-specific prognostic models that estimate the 10-year risk of people with non-diabetic hyperglycaemia developing type 2 ...diabetes.DesignRetrospective cohort study.SettingPrimary care.Participants154 705 adult patients with non-diabetic hyperglycaemia.Primary outcomeDevelopment of type 2 diabetes.MethodsThis study used data routinely collected in UK primary care from general practices contributing to the Clinical Practice Research Datalink. Patients were split into development (n=109 077) and validation datasets (n=45 628). Potential predictor variables, including demographic and lifestyle factors, medical and family history, prescribed medications and clinical measures, were included in survival models following the imputation of missing data. Measures of calibration at 10 years and discrimination were determined using the validation dataset.ResultsIn the development dataset, 9332 patients developed type 2 diabetes during 293 238 person-years of follow-up (31.8 (95% CI 31.2 to 32.5) per 1000 person-years). In the validation dataset, 3783 patients developed type 2 diabetes during 115 113 person-years of follow-up (32.9 (95% CI 31.8 to 33.9) per 1000 person-years). The final prognostic models comprised 14 and 16 predictor variables for males and females, respectively. Both models had good calibration and high levels of discrimination. The performance statistics for the male model were: Harrell’s C statistic of 0.700 in the development and 0.701 in the validation dataset, with a calibration slope of 0.974 (95% CI 0.905 to 1.042) in the validation dataset. For the female model, Harrell’s C statistics were 0.720 and 0.718, respectively, while the calibration slope was 0.994 (95% CI 0.931 to 1.057) in the validation dataset.ConclusionThese models could be used in primary care to identify those with non-diabetic hyperglycaemia most at risk of developing type 2 diabetes for targeted referral to the National Health Service Diabetes Prevention Programme.
Aim
To estimate the prevalence of both cardiometabolic and other co‐morbidities in patients with COVID‐19, and to estimate the increased risk of severity of disease and mortality in people with ...co‐morbidities.
Materials and Methods
Medline, Scopus and the World Health Organization website were searched for global research on COVID‐19 conducted from January 2019 up to 23 April 2020. Study inclusion was restricted to English language publications, original articles that reported the prevalence of co‐morbidities in individuals with COVID‐19, and case series including more than 10 patients. Eighteen studies were selected for inclusion. Data were analysed using random effects meta‐analysis models.
Results
Eighteen studies with a total of 14 558 individuals were identified. The pooled prevalence for co‐morbidities in patients with COVID‐19 disease was 22.9% (95% CI: 15.8 to 29.9) for hypertension, 11.5% (9.7 to 13.4) for diabetes, and 9.7% (6.8 to 12.6) for cardiovascular disease (CVD). For chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), cerebrovascular disease and cancer, the pooled prevalences were all less than 4%. With the exception of cerebrovascular disease, all the other co‐morbidities presented a significantly increased risk for having severe COVID‐19. In addition, the risk of mortality was significantly increased in individuals with CVD, COPD, CKD, cerebrovascular disease and cancer.
Conclusions
In individuals with COVID‐19, the presence of co‐morbidities (both cardiometabolic and other) is associated with a higher risk of severe COVID‐19 and mortality. These findings have important implications for public health with regard to risk stratification and future planning.
The objective was to develop and test a pragmatic critical appraisal tool, the Assessment of Real-World Observational Studies (ArRoWS), to quickly and easily assess the quality of real-world evidence ...studies using electronic health records.
The initial ArRoWS tool was developed by identifying items frequently found in existing validated assessment instruments and adapting these items to specifically assess real-world evidence studies. The tool was revised based on recommendations from an expert panel of 14 senior academic individuals specializing in epidemiology and content validity was measured. During March 2018–January 2019, 47 large, observational studies related to cardiometabolic medicine were identified through a search algorithm and assessed by three pairs of raters using the ArRoWS tool.
The final version of the ArRoWS had 16 items including nine core items and seven study design-specific items with item-specific content validity indexes ranging from 0.64 to 1.00. The scale-level content validity index of the ArRoWS appraisal tool was 0.91. When the ArRoWS tool was pilot tested, the observed agreement between assessor pairs on whether the study provided high-quality real-world evidence was 85.7%, 68.8%, and 58.8%. The prevalence adjusted bias-adjusted kappa for the assessor pairs was 0.71, 0.38, and 0.18.
The ArRoWS is a simple tool to standardize the assessment of real-world evidence studies.
Aim
To quantify the risk of cardiovascular disease (CVD) events, all‐cause mortality and cardiovascular mortality in patients diagnosed with type 2 diabetes (T2D) and multimorbidity.
Methods
This ...retrospective study used English primary and secondary care data to identify 120 409 adults newly diagnosed with T2D during 2000–2018 with follow‐up until death or 31 December 2018. Patients were classified according to the level and type of multimorbidity at T2D diagnosis, and adjusted hazard ratios (aHRs) were calculated for each outcome.
Results
In total, 66 977 (55.6%) patients had T2D only, 37 894 (31.5%) had one co‐morbidity, 11 357 (9.4%) had two co‐morbidities, 3186 (2.6%) patients had three co‐morbidities and 995 (0.8%) patients had four or more co‐morbidities. Co‐morbidities were associated with increased aHRs for all outcomes. Compared with patients with T2D only, at 19 years after diagnosis of T2D the aHR for four or more co‐morbidities was 2.57 (95% CI 2.45‐2.69) for a CVD event, 1.73 (1.68‐1.78) for all‐cause mortality and 2.68 (2.52–2.85) for cardiovascular mortality. Also, 100 183 (83.2%) patients had no CVD co‐morbidities, 16 874 (14.0%) patients had one CVD co‐morbidity and 3352 (2.8%) patients had two or more co‐morbidities. Compared with patients with no CVD co‐morbidities, at 19 years after diagnosis of T2D the aHR for two or more CVD co‐morbidities was 2.42 (2.35‐2.49) for a CVD event, 1.44 (1.42‐1.47) for all‐cause mortality and 2.44 (2.35‐2.54) for cardiovascular mortality.
Conclusion
In people with T2D, level of multimorbidity and, in particular, CVD multimorbidity increased the risk of subsequent CVD events, mortality and cardiovascular mortality.
Data on deaths of frontline HCPs in England with COVID-19 were collected through searches of news media reports. HCPs were categorised as doctor, nurse, or other (including ambulance, scientific, ...technical, and support staff, and direct care staff in general practices). We used December 2019 data for the corresponding numbers of registered HCPs in each occupation category and calculated crude cumulative weekly mortality rates per 1000 for each category, as well as for the general population. We were unable to stratify analyses by ethnicity as the ethnic composition of each occupation category was not available. Of the 147 frontline HCPs in England who died from COVID-19 between 25 March 2020 and 13 May 2020 for whom we had data, doctors accounted for 19.1% (n = 28, including 10 GPs), nurses 42.9% (n = 63), and other HCPs 38.1% {n = 56). Doctors experienced the earliest reported deaths among HCPs, but the cumulative mortality rate for nurses was comparable with doctors by the week of 18 April. The cumulative mortality rates were 0.15 per 1000 doctors, 0.17 per 1000 nurses, and 0.10 per 1000 other HCPs, compared with 0.74 per 1000 people in the English general population. From the available information, 35 out of 97 {36.1 %) were aged 60 years or more, 68 out of 147 (46.3%) were male, and 97 out of 128 (75.8%) were from non-white ethnic backgrounds. The mean age of white HCPs was 59.2 years compared with 54.6 years for non-white HCPs.
Introduction
As new glucagon-like peptide 1 receptor agonist (GLP-1 RA) formulations are available, the aim of this study was to understand dulaglutide and subcutaneous (s.c.) semaglutide dosing ...patterns in people with type 2 diabetes mellitus (T2DM) in the UK and Germany as well as oral semaglutide in the UK.
Methods
Adults with evidence of T2DM and a prescription of dulaglutide or semaglutide between August 2020 and December 2021 were identified using the IQVIA Longitudinal Prescription Data (LRx). Patients were divided into cohort 1 (incident users) and cohort 2 (prevalent users) based on previous exposure to GLP-1 RAs and were followed up to 12 months post-index.
Results
During the patient selection window in Germany and the UK, 368,320 and 123,548 patients respectively received at least one prescription of a study GLP-1 RA. Among dulaglutide users in Germany at 12 months post-index, the 1.5-mg dosage formulation was the most common for both cohort 1 (65.6%) and 2 (71.2%). Among s.c. semaglutide users at 12 months post-index, 39.2% and 58.4% of cohort 1 received 0.5 mg and 1.0 mg, respectively. In the UK, at 12 months post-index, the most common dulaglutide dosage formulation was 1.5 mg (71.7% cohort 1 and 80.9% cohort 2). Among s.c. semaglutide users at 12 months post-index, 0.5- and 1.0-mg formulations were the most common for both cohort 1 (38.9% and 56.0%, respectively) and cohort 2 (29.5% and 67.1%, respectively). Prescribing of the more recently introduced 3.0- and 4.5-mg formulations for dulaglutide and oral semaglutide was also reported in the study.
Conclusion
Dosing patterns of GLP-1 RAs, although similar between the UK and Germany, were heterogeneous over time. Given that the higher dulaglutide doses and oral semaglutide were recently introduced to the market, additional real-world evidence studies which include clinical outcomes is required.
Graphical Abstract
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