Developing a guideline for clinical trial protocol content: Delphi consensus survey

Trials

An-Wen Chan¹  David Moher²  Jennifer Marie Tetzlaff³ 

[1] Women’s College Research Institute at Women’s College Hospital, University of Toronto, 790 Bay Street, Toronto, ON, M5G 1N8, Canada;Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada;Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada

关键词: Reporting guideline;    Clinical trials;    Protocols;    SPIRIT Initiative;    Delphi consensus survey;    Randomized controlled trials;   

Others  :  1095311
DOI  :  10.1186/1745-6215-13-176

 received in 2012-03-31, accepted in 2012-09-07,  发布年份 2012

【 摘 要 】

Background

Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols.

Methods

Panellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance) and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages.

Results

Ninety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25^th percentile rating of 8 or greater), 13 of moderate importance (median 6 or 7) and 12 of low importance (median less than or equal to 5) for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions.

Conclusions

This Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of a guideline for protocol content.

【 授权许可】

   
2012 Tetzlaff et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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