简化研究你所选择的结果measurement instrument

The need for establishing core outcome sets for use in clinical trials is becoming well defined though special attention should be given to the instruments used for measuring these outcomes. Here, Cecilia Prinsen and Lidwine Mokkink, members of the COSMIN Steering Committee, discuss the implications and importance of a new consensus based guideline for selecting outcome measurement instruments, whichpublished today in试验.

Standardization in outcome reporting is vital.

临床试验用于通过评估干预对(主要)结果的影响来研究干预措施是否有效且安全。

The instrument chosen to measure the outcome of interest is of utmost importance: conclusions are merely based on the scores of this instrument of choice. Scores should therefore be reliable, valid, and responsive to change over time so the conclusions of your clinical trial can be trusted.

It is known, however, that the quality of outcome measurement instruments used in clinical trials varies considerably. Moreover, it is usually not apparent if the most reliable and valid outcome measurement instrument has been selected to measure the outcome of interest.

… the quality of outcome measurement instruments used in clinical trials varies considerably…

因此,令我们惊讶的是,在判断系统评价中临床试验研究的方法论质量时,几乎没有或什至没有关注纳入试验中使用的结果测量工具的质量。

What if the selected outcome measurement instrument is of poor quality? Not surprisingly, scores obtained cannot be interpreted nor be trusted. Consequently, wrong conclusions can be drawn.

The importance of uniformity in outcome reporting

使用不充分的结果测量工具是不道德的,也是浪费研究。因此,应仔细选择结果测量工具。目前,它应该是目前可用的最佳结果测量工具,因为我们需要确保我们可以依靠基于这些测量的结果。

使用不充分的结果测量工具是不道德的,也是浪费研究。

除了选择最佳结果测量仪器外,我们还有另一个重要方面要突出。

Multiple trials will often be used to answer a single research question. Our best evidence is found in a systematic review and meta-analysis in which the results of multiple clinical trials are compared and pooled, if possible.

We know thatdifferent outcome measurement instruments are continuously being used在特定健康领域的临床试验中测量相同的结果。

In arecent systematic review, written on behalf of the HOME (协调湿疹的结果指标) initiative, we identified 17 different outcome measurement instruments to measure health-related quality-of-life in adult patients with atopic eczema.

在结果测量和报告中缺乏标准化,使得在系统评价和荟萃分析的临床试验中比较和池结果非常困难甚至不可能。这是对比较有效性研究的严重威胁,因为它阻碍了临床试验证据的有用性来为医疗保健的决定提供信息。

而且,也已经证明了这些不合格的outcomes are not always the outcomes that patients say matter to them.

Towards standardization

A solution to the issues highlighted above is standardization in outcome reporting by means of developing and using Core Outcome Sets (COS).

ACOS是一组商定的最低结果that should be measured and reported in all clinical trials of a specific disease or trial population. It is a recommendation of what should be measured and reported in all clinical trials,howthe core outcomes should be measured, i.e. which outcome measurement instruments should be used.

The COMET (Core Outcome Measures in Effectiveness Trials) initiative brings together people interested in the development, reporting and application of COS.
The COMET (Core Outcome Measures in Effectiveness Trials) initiative brings together people interested in the development, reporting and application of COS.

COS的结果是基于共识的,涉及患者,医疗保健提供者和其他主要利益相关者;它们是对患者重要的结果。

但是,这不仅是重要的结果的选择,而且还选择了结果测量工具来衡量这些核心结果。基于对结果测量工具的全面评论,COS中包含的结果测量工具是目前可用的最佳仪器。

New guidelines for selecting your outcome measurement instrument

Published today in试验,我们提出了一项基于共识的指南,该指南描述了选择结果测量工具的方法,以涉及COS和临床试验中的任何疾病或健康和社会护理状况的结果。

…我们提出了一项基于共识的指南,该指南描述了选择结果测量工具的方法,以供COS和临床试验中的结果……

使用COS的确绝不意味着研究人员仅限于这些结果。实际上,特定临床试验的感兴趣结果可能与COS中的结果有所不同。相反,报告核心结果as a minimumin all clinical trials for a specific health area makes it possible to compare and combine results in systematic reviews and meta-analyses; it is key in comparative effectiveness research and evidence-based medicine.

To bring a medical field forward, without wasting resources, standardization in outcome reporting is considered vital.


cosminAre you interested in reading more about selecting outcome measurement instruments? The COSMIN (CO基于NSENSUSStandards for the selection of healthMeasurementINStruments)小组不断致力于通过开发选择最合适的工具的工具,从而改善研究和临床实践中的结果测量工具的选择,请参阅https://www.cosmin.nl/.

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