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EVALUATION OF OUTCOMES IN INTERVENTION RANDOMIZED CLINICAL TRIALS - DISTAL RADIUS FRACTURES
Davi Amorim Meira1, Lukas Eiki Moriyama2, Cássio Conceição Santana Santos3
1Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brazil.
Objectives:
Describe the frequency and types of outcomes in randomized clinical trials (RCT) of intervention for distal radius fractures, analyze how confusing outcome presentations can lead to misinterpretations, and suggest strategies to improve the reader's understanding of the decision-making process.
Methods:
A retrospective study was conducted through a systematized search on the PubMed® database in the last 10 years, in which only intervention RCT was included for distal radius fractures, and outcomes were analyzed.
Results:
Of the primary outcomes analyzed in the 75 selected articles, 46.6% were classified as clinical outcomes, 20% as surrogate, 30.6% as composite, 1.3% as complex scales, and 1.3% as safety outcomes. 34.7% of the articles did not report adverse events.
Conclusion:
The presentation of outcomes with little clinical relevance represented more than half of the sample (53.4%) - such studies can harm the reader since they confuse the interpretation of scientific evidence; the Core Outcome Measures in Effectiveness Trials (COMET) initiative could help health professionals in understanding and selecting the most appropriate therapeutic interventions for patients. .
