A comparison of hospital episode statistics and traditional methods to identify outcomes in a randomized trial; a sub-study of HEAT-PPCI

Blake, Sarah R; Roome, Claire; Shahzad, Adeel; Kemp, Ian; Mars, Christine; Wilson, Keith; Stables, Rod

doi:10.1093/pubmed/fdy225

Cited by 3 publications

(4 citation statements)

References 8 publications

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“…Fourth, participants in ASCEND had a mean follow-up of 7.4 years, and routine data may have greater utility in long-term chronic disease trials such as these, compared with trials of acute interventions where follow-up may be limited to a number of weeks meaning that precise timing of outcomes is important. 13 Finally, the ASCEND trial was carried out in the UK which has a national health service; the study therefore was not able to assess the reliability of routine data in non-UK countries, including those that do not have a single national healthcare provider nor if trials are conducted across different countries.…”

Section: Discussionmentioning

confidence: 99%

Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data

Harper

Mafham

Herrington

et al. 2023

Heart

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ObjectiveTo assess how reliable UK routine data are for ascertaining major bleeding events compared with adjudicated follow-up.MethodsThe ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo. The primary safety outcome was major bleeding (including intracranial haemorrhage, sight-threatening eye bleeding, serious gastrointestinal bleeding and other major bleeding (epistaxis, haemoptysis, haematuria, vaginal and other bleeding)) ascertained by direct-participant mail-based follow-up, with >90% of outcomes undergoing adjudication. Nearly all participants were linked to routinely collected hospitalisation and death data (ie, routine data). An algorithm categorised bleeding events from routine data as major/minor. Kappa statistics were used to assess agreement between data sources, and randomised comparisons were re-run using routine data.ResultsWhen adjudicated follow-up and routine data were compared, there was agreement for 318 major bleeding events, with routine data identifying 281 additional-potential events, and not identifying 241 participant-reported events (kappa 0.53, 95% CI 0.49 to 0.57). Repeating ASCEND’s randomised comparisons using routine data only found estimated relative and absolute effects of allocation to aspirin versus placebo on major bleeding similar to adjudicated follow-up (adjudicated follow-up: aspirin 314 (4.1%) vs placebo 245 (3.2%); rate ratio (RR) 1.29, 95% CI 1.09 to 1.52; absolute excess +6.3/5000 person-years (mean SE±2.1); vs routine data: 327 (4.2%) vs 272 (3.5%); RR 1.21, 95% CI 1.03 to 1.41; absolute excess +5.0/5000 (±2.2)).ConclusionsAnalyses of the ASCEND randomised trial found that major bleeding events ascertained via UK routine data sources provided relative and absolute treatment effects similar to adjudicated follow-up.Trial registration numberISRCTN60635500;NCT00135226.

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Section: Discussionmentioning

confidence: 99%

Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data

Harper

Mafham

Herrington

et al. 2023

Heart

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“…We ascertained index cardiovascular event from the start of the cohort to 1 January 2015 (ascertainment period) if an eligible International Classification of Diseases (ICD)-9 or ICD-10 code for cardiovascular disease was listed in the main diagnostic fields of their hospital admission ( online supplemental e-table 1 ) in the HES database. 10 We defined an index composite cardiovascular event as: myocardial infarction (ICD-9 410–11, ICD-10 I21-22), ischaemic heart disease including angina (ICD-9 412–414, ICD-10 I20) or stroke or transient ischaemic attack (TIA) (ICD-9 430–431, 434, 436, 3623, ICD-10 I60-64, H340-341, G45 except G456 and G457). We excluded participants who did not have a cardiovascular event during the ascertainment period, and those who died within 30 days following the index cardiovascular event (fatal event).…”

Section: Methodsmentioning

confidence: 99%

“…Cardiovascular event recurrence was ascertained based on a previously validated definition of first-ever hospital admission where the main diagnosis of the hospitalisation was listed as either stroke, TIA, myocardial infarction or ischaemic heart disease ( online supplemental e-table 1 ). 10 If another event occurred during follow-up, only the first event was included. Death due to cardiovascular disease was ascertained based on the death certificate listing cardiovascular disease as one of the responsible causes of death.…”

Section: Methodsmentioning

confidence: 99%

Cardiovascular disease recurrence and long-term mortality in a tri-ethnic British cohort

Vyas

Chaturvedi

Hughes

et al. 2020

Heart

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ObjectiveEthnic differences in cardiovascular disease incidence, but not cardiovascular disease recurrence, are reported. We characterised long-term risk of major adverse cardiovascular event (MACE) and mortality following a non-fatal cardiovascular event in a British cohort of South Asians, African Caribbeans and Europeans.MethodsWe identified index and recurrent cardiovascular events and mortality between 1988 and 2017 using hospital records and death registry. Using multivariable hazards models, we separately calculated the adjusted HR of MACE and death following index event, adjusting for demographics, vascular and lifestyle risk factors. Using interaction terms, we evaluated if decade of index event modified the association between ethnicity and outcomes.ResultsSouth Asians were younger at the index event (median age 66 years, n=396) than Europeans (69 years, n=335) and African Caribbeans (70 years, n=70). During 4228 person-years, of the 801 patients, 537 developed MACE and 338 died, with the highest crude rate of MACE in South Asians. On adjustment of baseline factors, compared with the Europeans, the higher risk of MACE (HR 0.97, 95% CI 0.77 to 1.21) and the lower risk of mortality (HR 0.95, 95% CI 0.72 to 1.26) in South Asians was eliminated. African Caribbeans had similar outcomes to Europeans (HR MACE 1.04, 95% CI 0.74 to 1.47; and HR death 1.07, 95% CI 0.70 to 1.64). Long-term survival following an index event improved in South Asians (ptrend 0.02) and African Caribbeans (ptrend 0.07) compared with Europeans.ConclusionsBaseline vascular risk factors explained the observed ethnic variation in cardiovascular disease recurrence and long-term mortality, with a relative improvement in survival of minority ethnic groups over time.

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“…To reduce potential inaccuracies, the endpoints used in this study were matched to specific International Classification of Diseases-codes. 13 Variables Used in the Equation of the ASCVD Score…”

Section: What Is Relevant?mentioning

confidence: 99%

Aortic Pulse Wave Velocity as Adjunct Risk Marker for Assessing Cardiovascular Disease Risk: Prospective Study

et al. 2022

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Background: Aortic pulse wave velocity is a noninvasive measure of aortic stiffness and arterial aging. Its current value in cardiovascular risk estimation practice is unknown. We aimed to establish whether aortic pulse wave velocity identified individuals with higher risk of incident major adverse cardiovascular events and improved performance of the American Heart Association/American College of Cardiology atherosclerotic cardiovascular disease risk score. Methods: This prospective analysis included 3837 Whitehall II cohort participants screened in 2008 to 2009, and followed for 11.7 years (mean=10.3, SD=1.81), without history of stroke, myocardial infarction, or coronary heart disease. Results: Mean age of the sample was 65.0 years (SD=5.6), 2831 participants (73.8%) were male and mean atherosclerotic cardiovascular disease risk score was 13.8%. At the end of follow-up, 411 individuals (10.7%) had suffered a major cardiovascular event. Those in the highest aortic pulse wave velocity quartile were at high risk (hazard ratio, 2.99 [95% CI, 2.25–3.97]) and reached the threshold for statin medication (7.5% risk) after 5 years whereas others reached it after 10 years (difference P <0.001). The addition of aortic pulse wave velocity to the risk score improved the C statistic (0.68 versus 0.67, P =0.03) and net reclassification index (4.6%, P =0.04 and 11.3%, P =0.02). Conclusions: Our results show that aortic stiffness predicted major adverse cardiovascular events in a cohort of elderly individuals, improving the performance of a widely used cardiovascular disease risk estimator. Aortic pulse wave velocity measurement is scalable, radiation-free, and easy to perform. Further studies on its applicability in cardiovascular disease risk assessment in primary care settings are needed.

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A comparison of hospital episode statistics and traditional methods to identify outcomes in a randomized trial; a sub-study of HEAT-PPCI

Cited by 3 publications

References 8 publications

Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data

Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data

Cardiovascular disease recurrence and long-term mortality in a tri-ethnic British cohort

Aortic Pulse Wave Velocity as Adjunct Risk Marker for Assessing Cardiovascular Disease Risk: Prospective Study

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