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回到临床:没有依据,就不存在有价值的研究问题。

De vuelta a la clínica: sin justificación no existe pregunta de investigación que valga.

作者信息

Talavera Juan O, Rivas-Ruiz Rodolfo, Pérez-Rodríguez Marcela, Roy-Garcia Ivonne Analí, Palacios-Cruz Lino

机构信息

Dirección de Enseñanza e Investigación, Centro Médico ABC. Ciudad de México, México.

Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Centro Médico Nacional Siglo XXI, Centro de Adiestramiento en Investigación Clínica. Ciudad de México, México.

出版信息

Gac Med Mex. 2019;155(2):168-175. doi: 10.24875/GMM.19004942.

Abstract

A clinical research question requires the concurrence of clinical experience and knowledge on methodology and statistics in that who formulates it. Initially, a research question should have a structure that clearly establishes what is that which is being sought (consequence or outcome), in whom (baseline status), and by action of what (maneuver). Subsequently, its reasoning must explore four aspects: feasibility and reasonableness of the questioning, lack of a prior answer, relevance of the answer to be obtained, and applicability. Once these aspects are satisfactorily covered, the question can be regarded as being "clinically relevant", which is different from being statistically significant, which refers to the probability of the result being driven by chance, which does not reflect the relevance of the question or the outcome. One should never forget that every maneuver entails adverse events that, when serious, discredit good results. It is imperative to have the possible answer estimated from within the structure of the question. The function of clinical research is to corroborate or reject a hypothesis, rather than to empirically test to find out what the outcome is.

摘要

一个临床研究问题需要在提出问题的人身上同时具备临床经验以及方法学和统计学知识。最初,一个研究问题应具备一种结构,该结构要明确确立所寻求的是什么(结果或结局)、针对谁(基线状态)以及通过何种行动(策略)来实现。随后,其推理必须探讨四个方面:问题的可行性和合理性、不存在预先的答案、所获得答案的相关性以及适用性。一旦这些方面得到令人满意的涵盖,该问题就可被视为“具有临床相关性”,这与具有统计学显著性不同,统计学显著性指的是结果由偶然因素导致的概率,它并不反映问题或结局的相关性。绝不能忘记,每一种策略都可能带来不良事件,严重时会使良好的结果大打折扣。必须从问题的结构中预估可能的答案。临床研究的功能是证实或否定一个假设,而不是通过实证检验去找出结果是什么。

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