Development, content validation and reliability of the Assessment of Real World Observational Studies (ArRoWS) critical appraisal tool

ObjectiveThe 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.MethodsThe 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 specialising 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.ResultsThe 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 0.64-1.00. 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.ConclusionThe ArRoWS is a simple tool to standardise the assessment of real world evidence studies.</div

Cardiovascular events and mortality in people with type 2 diabetes and multimorbidity: a real world study of patients followed up to 19 years

AimTo quantify the risk of cardiovascular disease (CVD) events, all‐cause mortality and cardiovascular mortality in patients diagnosed with type 2 diabetes (T2D) and multimorbidity.MethodsThis 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.ResultsIn 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.ConclusionIn people with T2D, level of multimorbidity and, in particular, CVD multimorbidity increased the risk of subsequent CVD events, mortality and cardiovascular mortality.</div

Is socio-economic deprivation associated with one-year post-operative mortality following major amputation for chronic limb-threatening ischaemia?

There is growing appreciation for the consequences of socio-economic deprivation on the development, recognition, and outcomes for patients with chronic limb threatening ischaemia (CLTI). Recently, it was identified that deprivation may influence the recognition of CLTI.1 Two contemporary studies, which investigated major UK based healthcare databases, also identified that deprivation was associated with increased risk of major amputation following revascularisation.2,3 However, whether this continues for outcomes following amputation is unknown. This study therefore aimed to investigate whether local area, neighbourhood socio-economic deprivation is associated with one year mortality following major amputation

Prediction of type 2 diabetes risk in people with non-diabetic hyperglycaemia: model derivation and validation using UK primary care data.

OBJECTIVE:Using 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. DESIGN:Retrospective cohort study. SETTING:Primary care. PARTICIPANTS:154 705 adult patients with non-diabetic hyperglycaemia. PRIMARY OUTCOME:Development of type 2 diabetes. METHODS:This 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. RESULTS:In 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. CONCLUSION:These 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

Cardiovascular events and mortality in people with and without type 2 diabetes: An observational study in a contemporary multi-ethnic population.

AimsExamine ethnicity‐specific associations between type 2 diabetes (T2DM) and risk of a cardiovascular disease (CVD) event as well as risk of specific CVD phenotypes in England.MethodsWe obtained data from the Clinical Practice Research Datalink for adults with and without T2DM diagnosed 2000‐2006. The outcome was the first CVD event during 2007‐2017 and 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 (aHR).Results734,543 people with and without T2DM (29,847; 4.1%) were included; most were of White ethnicity (93.0% with and 92.3% without T2DM) followed by South Asian (3.2% and 4.6%). During a median follow‐up of 11.0 years, 67,218 events occurred (6,156 in individuals with T2DM). T2DM was associated with a small increase in CVD events (aHR: 1.06; 95% CI: 1.02, 1.09) in individuals of White ethnicity; while the aHR was considerably higher in South Asians (1.28; 1.09, 1.51), primarily due to an increased risk of myocardial infarction (1.53; 1.08, 2.18).ConclusionsDespite universal access to healthcare, there are large disparities in CVD outcomes in people with and without T2DM. Other, non‐traditional risk factors may play a role in the higher CVD risk associated with T2DM in South Asians.</div

COVID-19 cumulative mortality rates for frontline healthcare staff in England

We aimed to determine the mortality rates of the main groups of frontline healthcare providers (HCPs) with COVID-19.Data on deaths of frontline HCPs in England with COVID-19 were collected through searches of news media reports.1,2 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 category3,4 and calculated crude cumulative weekly mortality rates per 1000 for each category, as well as for the general population.5,6 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.Although frontline HCPs may have had greater exposure than the general population, the relatively lower mortality rates in the HCP groups may be due to a number of factors: greater access to professional protection equipment (PPE), lower rates of comorbidity, and fewer very older people than the general population, although levels of non-white ethnicity are higher in HCPs. COVID-19 mortality has been under-reported, but over one-third of the doctors in our list were GPs despite rises in remote consulting. The increased risks to community-based HCPs should not be overlooked.</div

Rates and estimated cost of primary care consultations in people diagnosed with type 2 diabetes and comorbidities: A retrospective analysis of 8.9 million consultations

AimsTo determine whether telephone and face‐to‐face primary care consultation rates, costs, and temporal trends during 2000 to 2018 differed by the number of comorbidities in people with type 2 diabetes (T2DM).MethodsA total of 120 409 adults with newly diagnosed T2DM between 2000 and 2018 were classified by the number of prevalent and incident comorbidities. Data on face‐to‐face and telephone primary care consultations with a nurse or physician were obtained. Crude and sex‐ and age‐adjusted annual consultation rates and associated costs were calculated based on the number of comorbidities at the time of consultation.ResultsThe crude rate of face‐to‐face primary care consultations for patients without comorbidities was 10.3 (95% confidence interval [CI] 10.3‐10.4) per person‐year, 12.7 (95% CI 12.7‐12.7) for patients with one comorbidity, 15.1 (95% CI 15.1‐15.2) for those with two comorbidities, and 18.7 (95% CI 18.7‐18.8) for those with three or more comorbidities. The mean annual inflation‐adjusted cost for face‐to‐face consultations was £412.70 per patient without comorbidities, £516.80 for one comorbidity, £620.75 for two comorbidities, and £778.83 for three or more comorbidities. The age‐ and sex‐adjusted face‐to‐face consultation rate changed by an average of −3.3% (95% CI −4.4 to −2.3) per year from 2000 to 2018 for patients without comorbidities, −2.7% (95% CI −4.0 to −1.3) for those with one comorbidity, −2.2% (95% CI −3.3 to −1.2) for those with two comorbidities, and −4.3% (95% CI −8.7 to +0.3) for those with three or more comorbidities.ConclusionsAlthough consultation rates for all patients decreased from 2000 to 2018, there was a significant disparity between the rate for patients with and without comorbidities. Patients with T2DM and comorbidities may require different models of service delivery.</div

Impact of COVID-19 on routine care for chronic diseases: A global survey of views from healthcare professionals

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

Missed opportunities for timely recognition of chronic limb-threatening ischaemia in patients undergoing a major amputation: a population-based cohort study utilising the United Kingdom’s Clinical Practice Research Datalink

ObjectivesOpportunities for timely recognition of chronic limb-threatening ischaemia (CLTI) within primary care, such as performing cardiovascular assessment during clinical consultation, are possibly being missed. This study aims to investigate for potential ‘missed opportunities’ within primary care.MethodsPopulation-based cohort study, utilising the UK’s Clinical Practice Research Datalink (CPRD). Patients undergoing a major amputation for CLTI between 01/01/2000-31/12/2016 were included. Primary care consultation and patient clinical data within the one-year period prior to amputation were extracted from the CPRD. Dates of last primary care consultation and cardiovascular assessment prior to amputation were evaluated. Timings of latest cardiovascular assessments were stratified into ‘recent’ (7-90 days before amputation) and ‘late’ (>91 days).Results3260 patients were included. In the year prior to amputation, patients attended a median of 19 [9-32] primary care consultations, however prescription of secondary preventative medications was poor (antiplatelet=49.7%, lipid lowering agent=40.7%). Overall, 2175 patients (66.7%) attended a primary care consultation 7-30 days before their amputation. However, only 416 (12.8%) underwent a cardiovascular assessment within this period, with 2073 (63.6%) undergoing no assessment within 90 days of their amputation. Of these 2073 patients, 1230 (59.3%) had a primary care consultation 7-30 days before their procedure. Patients undergoing ‘late’ assessment were younger (p=.003), with higher systolic (p=.008) and diastolic (p=.001) blood pressures than those undergoing ‘recent’ assessment. Differences were also observed between timings of assessment by deprivation (p=.003) and ethnicity (p=.006).ConclusionMissed opportunities for timely recognition potentially exist and may be related to age, deprivation and ethnicity. Further work is required to investigate these factors, as well as individual amputations to identify the causes precipitating amputation. Greater emphasis on the medical management of peripheral arterial disease and identifying cardiovascular risk factors in patients who may not fit the ‘at risk’ stereotype, are also required.</p

Mortality in a Multiethnic Population Attending a One-Stop TIA Clinic

Introduction: Studies indicate a 13–27% mortality rate following a transient ischaemic attack (TIA). However, outcomes following TIA/minor stroke since the introduction of rapid-access TIA clinics and prompt vascular risk factor intervention are not known. Specifically, there is paucity of data comparing outcomes between people who are diagnosed with an “acute cerebrovascular” (CV) event or an alternative non-cardiovascular diagnosis (non-CV) in a rapid-access TIA clinic. We aimed to assess the mortality in such a setting. Methods: A retrospective observational study was undertaken at the Leicester rapid-access secondary care TIA clinic. Data included information collected at the first clinic visit (including comorbidities, and primary diagnosis, categorized as CV and non-CV) and the date of death for people dying during follow-up. Results: 11,524 subjects were included with 33,164 years of follow-up data; 4,746 (41.2%) received a CV diagnosis. The median follow-up time was 2.75 years (interquartile range 1.36–4.32). The crude mortality rate was 37.3 (95% CI: 35.3–39.5) per 1,000 person-years (PTPY). The mortality rate was higher following a CV diagnosis (50.8 [47.2–54.7] PTPY) compared to a non-CV diagnosis (27.9 [25.7–30.4] PTPY), and for males, older people, those of white ethnicity, and people with orthostatic hypotension (OH). Discussion: This study identified possible risk factors associated with a higher mortality in TIA clinic attendees, who may benefit from specific intervention. Future research should explore the underlying causes and the effect of specific targeted management strategies.</p