Desfechos combinados em ensaios clínicos randomizados sobre intervenções farmacológicas para doença arterial coronária: meta-pesquisa
Data
2024-11-13
Autores
Barros, Valéria Mozetic de 
Orientadores
Riera, Rachel
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Objetivos: Identificar os desfechos combinados utilizados nas análises de ensaios clínicos randomizados na doença arterial coronária, mostrar a frequência da a ocorrência deste fenômeno e os riscos que a presença deste tipo de relato impõe. Desenho de estudo e local: Estudo transversal de ensaios clínicos randomizados publicados em revistas biomédicas indexadas no MEDLINE (via PubMed) entre 2020 e 2021, conduzido na Universidade Federal de São Paulo (Unifesp). Métodos: Buscamos por ensaios clínicos randomizados indexados no MEDLINE (via PubMed) e publicados entre 1º de janeiro de 2020 e 31 de dezembro de 2021 incluindo pacientes portadores de doença arterial coronária que tivessem sido submetidos restritamente a intervenção farmacológica cardiovascular alopática e que não fosse suplementação alimentar. Os ensaios clínicos foram identificados por estratégia de busca e selecionados por dois autores independentes. Os títulos selecionados foram lidos na íntegra para identificação e qualificação dos desfechos combinados. Divergências no processo de seleção e extração de dados foram resolvidas por um terceiro pesquisador. Resultados: Buscas eletrônicas recuperaram 12.294 referências, sendo 12.241 eliminadas na primeira fase por não preencherem os critérios de inclusão. Após leitura do texto completo de 53 referência pré- selecionadas, 34 referências foram incluídas. Desses 34 ensaios clínicos randomizados 28 (82,35%) apresentavam desfechos combinados. Treze desfechos primários combinados foram usados, sendo mais frequente "morte cardiovascular- infarto do miocárdio-acidente vascular cerebral" (12/28, 42,86%). O termo MACE (Maiores eventos adversos cardiovasculares) foi usado para cinco desfechos primários combinados distintos. Uma combinação de 12 componentes diferentes resultou nos 28 desfechos combinados primários, sendo o AVC o componente mais frequente presente em 96,43% (27/28) dos desfechos combinados primários. Dos estudos incluídos nenhum discutiu possíveis limitações e/ou vantagens relacionadas aos desfechos combinados. Conclusão: Em ensaios clínicos randomizados sobre intervenção farmacológica para doença arterial coronária o uso de desfechos combinados são frequentemente utilizados. A apresentação dos componentes dos desfechos é heterogênea e muitas vezes a estimativa para cada componente de forma individual não é apresentada. Causando uma análise muitas vezes errônea para os leitores que irão usar estes dados na prática clínica.
Objectives: To list the combined outcomes that occurred in randomized clinical trials in coronary artery disease, explain the occurrence of this phenomenon, the risks that the presence of this type of report imposes and seek solutions to this problem. Study design and setting: Cross-sectional study of randomized clinical trials published in PubMed between 2020 and 2021, conducted at the Federal University of São Paulo (Unifesp). Methods: We searched for randomized clinical trials published in PubMed between January 1, 2020, and December 31, 2021, in patients with coronary artery disease who had been strictly submitted to allopathic cardiovascular pharmacological intervention other than dietary supplementation. Clinical trials were identified by search strategy and selected by two independent authors according to the search criteria. The selected titles were read in full to identify and qualify the composite outcomes. Differences in the selection process and data extraction were resolved by a third researcher. Quantitative analysis and discussion were presented. Results: Electronic searches retrieved 12,294 references, 12,241 of which were eliminated in the first phase because they did not meet the inclusion criteria. After reading the full text of 53 pre-selected references, thirty-four references were included. Of these 34 randomized clinical trials, 28 (82.35%) had combined outcomes. Thirteen unique combined primary outcomes were used, the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term MACE was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. None of the included studies discussed possible limitations and/or advantages related to combined outcomes. Conclusion: The findings of this study showed that the main justifications for presenting the composite outcomes were the small sample and the high cost that randomized clinical trials require, thus using the subterfuge of combined outcomes to complete the studies, which can cause an analysis many times erroneous for readers who will use these data in clinical practice.
Objectives: To list the combined outcomes that occurred in randomized clinical trials in coronary artery disease, explain the occurrence of this phenomenon, the risks that the presence of this type of report imposes and seek solutions to this problem. Study design and setting: Cross-sectional study of randomized clinical trials published in PubMed between 2020 and 2021, conducted at the Federal University of São Paulo (Unifesp). Methods: We searched for randomized clinical trials published in PubMed between January 1, 2020, and December 31, 2021, in patients with coronary artery disease who had been strictly submitted to allopathic cardiovascular pharmacological intervention other than dietary supplementation. Clinical trials were identified by search strategy and selected by two independent authors according to the search criteria. The selected titles were read in full to identify and qualify the composite outcomes. Differences in the selection process and data extraction were resolved by a third researcher. Quantitative analysis and discussion were presented. Results: Electronic searches retrieved 12,294 references, 12,241 of which were eliminated in the first phase because they did not meet the inclusion criteria. After reading the full text of 53 pre-selected references, thirty-four references were included. Of these 34 randomized clinical trials, 28 (82.35%) had combined outcomes. Thirteen unique combined primary outcomes were used, the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term MACE was used for five distinct composite primary outcomes. A combination of 12 different components resulted in the 28 primary composite outcomes, with stroke being the most frequent component present in 96.43% (27/28) of the primary composite outcomes. None of the included studies discussed possible limitations and/or advantages related to combined outcomes. Conclusion: The findings of this study showed that the main justifications for presenting the composite outcomes were the small sample and the high cost that randomized clinical trials require, thus using the subterfuge of combined outcomes to complete the studies, which can cause an analysis many times erroneous for readers who will use these data in clinical practice.
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Citação
BARROS, Valéria Mozetic de. Desfechos combinados em ensaios clínicos randomizados sobre intervenções farmacológicas para doença arterial coronária: meta-pesquisa. 2024. 107 f. Tese (Doutorado em Saúde Baseada em Evidências) - Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP). São Paulo, 2024.