健康结局指标效应量决策阈值制定方法指南

A guideline for determining the effect size decision threshold of health outcomes

临床循证决策过程中需要基于最佳证据,综合考虑干预措施利弊大小、证据确信度、成本与可行性等因素。通过制定患者健康结局指标效应量决策阈值(decision threshold of effect size,DTES),能够帮助利益相关者理解干预措施利弊大小、评估证据确信度和解读研究结果。MERGE工作组充分借鉴国际经验,通过小组讨论、半结构化访谈、专家共识和试点应用,开发了一套包括8个步骤的健康结局指标DTES制定方法指南,包括:必要性评估、组建工作组、遴选患者重要结局、基于最佳证据制作情景示例、设计专家函询问卷、分析专家涵询结果、面对面专家共识以及推广应用与后效评价。DTES指南的开发,以期为利益相关者制定不同领域健康结局指标的DTES提供方法指导。

In the clinical evidence-based decision-making process,factors including benefits and harms,evidence certainty,cost and feasibility of interventions should be considered based on the best evidence.The development of decision threshold of effect size(DTES)for patient health outcomes can help stakeholders understand the benefits and harms of interventions,assess evidence certainty,and interpret research results.Based on international experience,the MERGE Working Group through group discussions,semi-structured interviews,expert consensus,and pilot application developed a set of 8-step guidelines for the development of DTES for health outcomes.These steps included necessity assessment,formation of working groups,selection of patient important outcomes,creation of scenarios based on the best evidence,design of expert consultation questionnaires,analysis of expert consultation results,face-to-face expert consensus,dissemination of the application and reevaluation.The DTES guideline development is intended to provide methodological guidance for stakeholders to develop DTES for health outcome indicators in different domains.