共识研究：一项混合方法研究的方案，旨在确定口咽癌核心结局集应包含哪些结局。

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

作者信息

Waters Aoife Mi, Tudur Smith Catrin, Young Bridget, Jones Terry M

机构信息

Department of Biostatistics, University of Liverpool, 1st Floor Duncan Building, Daulby Street, Liverpool L69 3GA, UK.

出版信息

Trials. 2014 May 13;15:168. doi: 10.1186/1745-6215-15-168.

DOI:10.1186/1745-6215-15-168

PMID:24885068

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4023496/

Abstract

BACKGROUND

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare.

METHODS/DESIGN: This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study.

DISCUSSION

A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research.

TRIALS AND REGISTRATION

This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

摘要

背景

在发达国家，口咽癌的发病率正在上升。这导致该领域的研究活动和临床试验大幅增加，但对于应测量哪些结果尚无共识。因此，在可比干预措施的试验中，所测量的结果往往存在差异，使得不同试验结果的合并或比较变得不可能。结果也可能被“挑选”，即只报告有利的结果，而隐瞒不太有利的结果。制定一个最低结果报告标准，即核心结局集，在一定程度上解决了这些问题。核心结局集理想情况下采用以患者为中心的方法来制定，以便所测量的结果与患者和临床实践相关。核心结局集通过确保在特定健康或医疗领域的试验中始终测量和报告正确的结果，提高了研究的质量和相关性。

方法/设计：这是一项混合方法研究，包括三个阶段，以制定口咽癌临床试验的核心结局集。首先，系统评价将确定已发表的口咽癌随机对照试验（RCT）中测量了哪些结果。其次，对英国和美国的患者及护理人员进行定性访谈，旨在确定哪些结果对这些利益相关者很重要。前两个阶段的数据将用于制定一份可纳入核心结局集的全面结果清单。在第三阶段，患者和临床医生将参与一项名为德尔菲研究的迭代共识练习，以完善核心结局集的内容。本方案列出了将在共识研究中实施的方法。