A first step to assess harm and benefit in clinical trials in one scale
A first step to assess harm and benefit in clinical trials in one scale
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DOI：
10.1016/j.jclinepi.2009.07.002
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发表时间：
2010-06-01
影响因子：
7.2
通讯作者：
Tugwell, Peter
中科院分区：
文献类型：
--
作者：
Boers, Maarten;Brooks, Peter;Tugwell, Peter
目的：开发一个简单的系统来评估治疗的好处和伤害在一个单一的规模。需要从正确的角度来看待试验中的损害和益处信号，以决定治疗的价值。已经开发了几种评估系统，但很少有人尝试将获益和风险纳入同一指标，同时保留足够的简单性，以帮助患者和临床医生做出决策。（流变学结局指标[OMERACT] 3 x 3），包括有益和有害结局的三个等级：对于益处，这些是“无”、“实质性”和“（接近）缓解”;对于损害，这些是“无”、“严重”和“（接近）死亡”。“患者的利益和伤害都进行了排名，随后在一个3 × 3的表中计算。结果：该系统是可行的，当应用于一个试验少女（患者水平的信息）和荟萃分析。要成为适用的工具，几个问题需要解决，在进一步的发展，特别是定义和cutoffs的ranks.Conclusion：一个简单的3 × 3的表来排名的好处和伤害的结果是可行的。对于风湿病学，这将在OMERACT倡议的背景下进一步发展。(C)2010年爱思唯尔公司All rights reserved.
Objective: To develop a simple system to assess benefit and harm of treatment on a single scale. Harm and benefit signals from trials need to be placed in the proper perspective to decide on the value of a treatment. Several systems have been developed for assessment, but few attempt to incorporate both benefit and risk in the same metric while retaining enough simplicity to aid patients and clinicians in their decision making.Study Design and Setting: We designed a very simple 3 x 3 table (Outcome Measures in Rheumatology [OMERACT] 3 x 3) that comprises three ranks for both beneficial and harm outcomes: for benefit, these are "none," "substantial," and "(near) remission"; for harm, these are "none," "severe," and "(near) death." Patients are ranked both for benefit and harm and subsequently counted in a 3 x 3 table.Results: The system was feasible when applied to one trial damsel (patient-level information) and a meta-analysis. To become applicable as a tool, several issues need to be resolved in further development, especially the definitions and cutoffs for the ranks.Conclusion: A simple 3 x 3 table to rank both benefit and harm outcomes is feasible. For rheumatology this will be further developed in the context of the OMERACT initiative. (C) 2010 Elsevier Inc. All rights reserved.