Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial
| Autor: | Dennis E. Niewoehner, Julie C. Yates, Camilo R Gomez, Courtney Crim, Pierre Amarenco, Matthew P.A. Jones, Robert A. Wise, Julie A. Anderson, Martin A. Denvir, Andrea Morris, Nicholas J. Cowans |
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| Rok vydání: | 2020 |
| Předmět: |
unstable angina
medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Endpoint Determination Myocardial Infarction Pulmonary disease 030204 cardiovascular system & hematology Chlorobenzenes Pulmonary Disease Chronic Obstructive 03 medical and health sciences 0302 clinical medicine Risk Factors Internal medicine Humans Medicine major adverse cardiovascular event adjudication In patient Angina Unstable Myocardial infarction Stroke Benzyl Alcohols Randomized Controlled Trials as Topic Adjudication Pharmacology geography Summit geography.geographical_feature_category business.industry Unstable angina Articles General Medicine medicine.disease stroke Bronchodilator Agents Androstadienes Drug Combinations Chronic obstructive pulmonary disease mortality 030228 respiratory system Cardiovascular Diseases Cardiology Clinical Trials Data Monitoring Committees business |
| Zdroj: | Wise, R A, Anderson, J A, Amarenco, P, Cowan, N J, Crim, C, Denvir, M, Gomez, C R, Jones, M PA, Morris, A, Niewoehner, D & Yates, J C 2020, ' Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial ', Clinical Trials . https://doi.org/10.1177/1740774520920897 Clinical Trials (London, England) |
| ISSN: | 1740-7753 1740-7745 |
| DOI: | 10.1177/1740774520920897 |
| Popis: | Background: Adjudicated cause-specific mortality has been used in major trials of chronic obstructive pulmonary disease. However, there is less experience with adjudicated major adverse cardiovascular events as a key efficacy outcome in chronic obstructive pulmonary disease trials. The Study to Understand Mortality and Morbidity in chronic obstructive pulmonary disease trial required a Clinical Endpoint Committee to adjudicate the outcomes of modified major adverse cardiovascular events and cause-specific mortality. Methods and results: A six-member Clinical Endpoint Committee reviewed adverse event and serious adverse event reports included in a list of 204 Medical Dictionary for Regulatory Activities terms. Adverse events were triaged by one Clinical Endpoint Committee member, and then reviewed by three reviewers (round 1). If these three disagreed on the adjudication, the event was discussed by the full committee to reach a consensus (round 2). Among 16,485 participants, 48,105 adverse events were reported, among which 3314 were reviewed by the Clinical Endpoint Committee. After triage, 1827 were adjudicated in round 1; 338 required committee consensus in round 2, yielding 450 myocardial infarctions, strokes, unstable anginas or transient ischaemic attacks. Only 20/1627 (1%) non-serious adverse events were adjudicated as cardiovascular events. Only 45/204 Medical Dictionary for Regulatory Activities terms reviewed yielded cardiovascular events. A total of 430 deaths were adjudicated in round 1 and 631 in round 2, yielding 459 cardiovascular deaths. Adjudication of chest pain and sudden death often required additional information from site investigators. Site assessment of cardiovascular death was moderately specific (501/602 = 83%) but not sensitive (256/459 = 56%). Conclusion: A Clinical Endpoint Committee is useful for adjudication of major adverse cardiovascular events in chronic obstructive pulmonary disease trials but requires considerable resources and effort by investigators. This process can be streamlined by reviewing only serious adverse events and filtering by selected Medical Dictionary for Regulatory Activities terms. |
| Databáze: | OpenAIRE |
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