彗星VI:让每个人都参与核心结果集

TheISRCTN注册表邀请介绍有关改善今年临床试验记录中列出的结果指标的发现COMET VI meetingin Amsterdam. Here, Alison Cuff discusses what she learned about the exciting research in this area and possible future developments.

在临床试验中,测量了生物医学或与健康相关的结果(例如生活质量,副作用或疼痛),以评估特定治疗的工作状况,通常将新疗法与标准护理进行比较。核心结果集是商定成果的列表,可以通过使人们能够比较相同健康状况的不同临床试验之间的发现来帮助确定哪种治疗方法最有效。但是,只有在以下方式时才能进行这些比较

  1. An agreed core outcome set exists; and
  2. Researchers running clinical trials on the same medical condition all measure these outcomes.

This is where the有效性试验(COMET)倡议中的核心成果指标进来。2010年推出,这是一项国际合作,旨在提供资源来帮助人们交流思想和信息,并支持相关研究,以开发核心成果集。

该彗星倡议于2010年启动

TheISRCTN注册表have been working with the COMET Initiative to improve how outcome measures are listed in the clinical trial records submitted for registration, by providing guidance to trialists submitting their studies for registration and referring them to the COMET Initiative resource, as appropriate. I was invited to present our findings so far at the年度彗星会议, which this year was held in Amsterdam on 10–11 November.

核心结果集的发展

会议的开幕会议设定了我认为是整个会议的主题,即公众和患者参与的主题。关于患者和普通成员所做的贡献不断提高,他们自己如何看待他们的贡献以及他们认为与他们最相关的结果措施的贡献都有很多讨论。

这包括有关COMET People Participation Involvement and Engagement (PoPPIE) Working group。The COMET initiative set up this group to support researchers working with patients, parents, carers and other members of the public to help develop core outcome sets; here they showcased the group’s current resources and describing their plans for the future.

The increasing emphasis on public and patient participation became clearer still as groups described how they developed their individual core outcome sets; most talked about consensus meetings with patient groups and health professionals and how each group facilitated the process.

Pixabay
A group at Imperial College London are currently working on a neonatal core outcome set
Pixabay

One study that was slightly different, however, involved looking at pre-existing data, such as published papers, systematic reviews and “grey literature” databases to develop parent and patient outcomes for a新生儿核心结果集。分析中包括超过1000篇论文,从中获得了新生儿结局对以前的患者,父母和卫生专业人员很重要的数据。现在正在完成工作以确定此现有数据是否足以开发新生儿核心结果集。

核心结果集的实施

但是happens once a core outcome set has been agreed upon? This question was tackled by a range of talks from researchers investigating different ways of promoting the use of outcome sets and how to implement them. Of particular interest to me was some research taking place at the University of Liverpool,将引文视为衡量有多少人使用核心结果集的手段

Classification of Core Outcome Sets

关于不同结果指标的分类也有一些谈判。其中包括开发从彗星数据库中包括的Cochrane系统评价中确定的核心结果集中包含的结果的分类系统。CFAST项目

我个人的亮点之一是描述Cochrane PICO。This ontology is used for the annotation of evidence using a variety of tools including a PICO annotator, PICOfinder browser and vocabulary browser. As part of this work, Cochrane uses a 14-item categorisation of outcomes as developed by the COMET initiative.

My other highlight, of course, was being given the opportunity to describe the work undertaken by the ISRCTN over the course of this year to improve the quality of the outcome measures included as part of a registered study record. The results so far, which do indeed show an improvement, are qualitative in nature but do raise several intriguing questions for the future, such as (1) to what extent do ISRCTN outcome measures reflect core outcome sets and (2) whether clinical trial records have a role to play in promoting them.

The ISRCTN registry have been working to improve the quality of outcome measures listed in registered study records.

Final Thoughts on Core Outcome Sets

I found the conference to be very enlightening and I learned a significant amount about how core outcome sets are developed, how important is it to involve patients and the general public in the process and what people are doing with existing core outcome sets now. I look forward to seeing how the COMET Initiative resource expands to include an ever-increasing number of core outcome sets and what future developments unfold.

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