EVALUATION OF OUTCOMES IN INTERVENTION RANDOMIZED CLINICAL TRIALS - DISTAL RADIUS FRACTURES.

IF 0.5 4区医学 Q4 ORTHOPEDICS

Acta Ortopedica Brasileira Pub Date : 2023-01-01 DOI:10.1590/1413-785220233103e267872

Davi Amorim Meira, Lukas Eiki Moriyama, Cássio Conceição Santana Santos, Fernando Delmonte Moreira, Alex Guedes, Enilton de Santana Ribeiro de Mattos

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Abstract

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. Level of Evidence III; Retrospective comparative study .

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干预随机临床试验的结果评价-桡骨远端骨折。

目的:描述干预桡骨远端骨折的随机临床试验(RCT)结果的频率和类型，分析混乱的结果如何导致误解，并提出提高读者对决策过程理解的策略。方法:通过系统化检索PubMed®数据库近10年的回顾性研究，其中仅纳入桡骨远端骨折的干预RCT，并对结果进行分析。结果:在选定的75篇文章中分析的主要结局中，46.6%为临床结局，20%为替代结局，30.6%为综合结局，1.3%为复杂结局，1.3%为安全结局。34.7%的文章未报告不良事件。结论:半数以上的样本(53.4%)所呈现的结果与临床无关——这类研究可能会损害读者，因为它们混淆了对科学证据的解释;有效性试验的核心结果测量(COMET)倡议可以帮助卫生专业人员了解和选择最适合患者的治疗干预措施。证据等级III;回顾性比较研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta Ortopedica Brasileira Orthopedics-

CiteScore

0.90

自引率

14.30%

发文量

审稿时长

25 weeks

期刊介绍： A Revista Acta Ortopédica Brasileira, órgão oficial do Departamento de Ortopedia e Traumatologia da Faculdade de Medicina da Universidade de São Paulo (DOT/FMUSP), é publicada bimestralmente em seis edições ao ano (jan/fev, mar/abr, maio/jun, jul/ago, set/out e nov/dez) com versão em inglês disponível nos principais indexadores nacionais e internacionais e instituições de ensino do Brasil. Sendo hoje reconhecidamente uma importante contribuição para os especialistas da área com sua seriedade e árduo trabalho para as indexações já conquistadas.

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