使用推荐评估、制定与评估（GRADE）证据决策（EtD）框架定义健康获益和危害判断的决策阈值：一项随机方法学研究（GRADE-THRESHOLD）方案。
Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD).
机构信息
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres, McMaster University, Hamilton, Ontario, Canada.
出版信息
BMJ Open. 2022 Mar 10;12(3):e053246. doi: 10.1136/bmjopen-2021-053246.
INTRODUCTION
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) and similar Evidence to Decision (EtD) frameworks require its users to judge how substantial the effects of interventions are on desirable and undesirable people-important health outcomes. However, decision thresholds (DTs) that could help understand the magnitude of intervention effects and serve as reference for interpretation of findings are not yet available.The objective of this study is an approach to derive and use DTs for EtD judgments about the magnitude of health benefits and harms. We hypothesise that approximate DTs could have the ability to discriminate between the existing four categories of EtD judgments (Trivial, Small, Moderate, Large), support panels of decision-makers in their work, and promote consistency and transparency in judgments.
METHODS AND ANALYSIS
We will conduct a methodological randomised controlled trial to collect the data that allow deriving the DTs. We will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, we will investigate the validity of our DTs by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that our DTs approach would suggest if applied on the same guideline data.
ETHICS AND DISSEMINATION
The Hamilton Integrated Research Ethics Board reviewed this study as a quality improvement study and determined that it requires no further consent. Survey participants will be required to read a consent statement in order to participate in this study at the beginning of the trial. This statement reads: You are being invited to participate in a research project which aims to identify indicative DTs that could assist users of the GRADE EtD frameworks in making judgments. Your input will be used in determining these indicative thresholds. By completing this survey, you provide consent that the anonymised data collected will be used for the research study and to be summarised in aggregate in publication and electronic tools.
PROTOCOL REGISTRATION NUMBER
NCT05237635.
简介
推荐分级评估、制定与评价（GRADE）和类似的证据决策（EtD）框架要求其使用者判断干预措施对理想和不理想的人群重要健康结局的影响有多大。然而，用于理解干预效果的幅度并作为解释发现的参考的决策阈值（DT）尚不存在。本研究的目的是提出一种方法，用于推导和使用 EtD 判断健康收益和危害幅度的 DT。我们假设近似 DT 能够区分现有 EtD 判断的四个类别（微不足道、小、中、大），为决策者小组的工作提供支持，并促进判断的一致性和透明度。
方法和分析
我们将进行一项方法学随机对照试验，以收集允许推导 DT 的数据。我们将邀请临床医生、流行病学家、决策科学家、健康研究方法学家、健康技术评估（HTA）专家、指南制定小组的成员和公众参与试验。然后，我们将通过测量过去由指南小组做出的判断与我们的 DT 方法如果应用于相同的指南数据会建议的判断之间的一致性，来研究我们的 DT 的有效性。
伦理和传播
汉密尔顿综合研究伦理委员会将这项研究作为一项质量改进研究进行了审查，并确定它不需要进一步的同意。在试验开始时，调查参与者将被要求阅读一份同意声明，以参与这项研究。该声明写道：您被邀请参加一项研究项目，旨在确定可以帮助 GRADE EtD 框架使用者做出判断的指示性 DT。您的意见将用于确定这些指示性阈值。通过完成此调查，您同意将收集的匿名数据用于研究，并在发表和电子工具中以汇总形式进行总结。
协议注册编号
NCT05237635。
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