Guideline created for 'transparent and complete' clinical trial reporting

By Melissa Fassbender contact

- Last updated on GMT

The new guideline focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. (Image: iStock/thomas-bethge)
The new guideline focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. (Image: iStock/thomas-bethge)
Researchers have developed a new international guideline to help standardize how clinical trial study results are reported.

According to the researchers' paper recently published​ in PLOS, "There is growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials​."

To address these issues, Dr Jamie Kirkham and Professor Paula Williamson from the University of Liverpool led an international group of researchers to develop the Core Outcome Set–STAndards for Reporting Statement, as a reporting guideline for core outcome set (COS) studies.

(Image: Core Outcome Set–STAndards for Reporting: The COS-STAR Statement. Jamie J. Kirkham Sarah Gorst Douglas G. Altman Jane M. Blazeby Mike Clarke Declan Devane Elizabeth Gargon David Moher Jochen Schmitt Peter Tugwell Sean Tunis Paula R. Williamson)
(Image: Core Outcome Set–STAndards for Reporting: The COS-STAR Statement. Jamie J. Kirkham Sarah Gorst Douglas G. Altman Jane M. Blazeby Mike Clarke Declan Devane Elizabeth Gargon David Moher Jochen Schmitt Peter Tugwell Sean Tunis Paula R. Williamson)

The statement outlines a checklist of 18 items which have been deemed essential for “transparent and complete​” reporting in all COS studies (see right).

The consensus process was informed by the views of nearly 200 participants across key stakeholder groups in a two-round international, online Delphi survey​,” Kirkham told Outsourcing-Pharma.com.

We regard the COS-STAR Statement to be relevant to all COS developers wishing to report their studies, regardless of the methodology used to develop the COS and the various participant groups who may have been involved in selecting outcomes​,” he added.

A better outcome with core outcome sets?

According to the researchers, the use of core outcome sets can help improve consistency in outcome measurement and reduce outcome reporting bias, which Kirkham said “has led to much unnecessary waste in the production and reporting of research​.”

However, Kirkham explain, “Recent work has shown that reporting quality of COS studies is currently variable, restricting the ability of potential users of COS, for example clinical trialists, systematic reviewers and guideline developers, to assess the relevance to their own work​.”

Furthermore, the reporting quality of COS development studies is also relevant to implementation​,” Kirkham added. 

With over 100 COS studies either ongoing or planned, the COS-STAR guideline is a resource to improve the reporting of COS studies for the benefit of all core outcome set users​.”

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