ROBUST-RCT is a rigorously developed, simply structured, and user friendly instrument for assessing risk of bias of randomized controlled trials in systematic reviews.
ROBUST-RCT provides six core items, each of which includes two steps: to evaluate what happened in individual trials and to judge the risk of bias based on what happened. ROBUST-RCT also provides eight optional items that systematic reviewers might consider relevant in specific circumstances.
- Preparatory work, including a systematic survey of existing risk of bias instruments for candidate item collection and a systematic survey of meta-epidemiological studies addressing the impact of potential risk of bias items on effect estimates, supported development of ROBUST-RCT.
- The panel used six criteria to help decisions regarding item selection. These criteria measured the items from different dimensions in a comprehensive and clear way.
- User testing with both junior and experienced senior systematic reviewers confirmed the simplicity and ease of practical application of ROBUST-RCT.
- ROBUST-RCT is the risk of bias instrument recommended by Core GRADE.
Download the ROBUST-RCT in PDF or Word format, or access the accompanying Manual for detailed elaborations and examples.
Systematic reviewers can use this visualization tool to generate a color-coded risk-of-bias figure. See example risk-of-bias figure below.
Wang Y, Keitz S, Briel M, Glasziou P, Brignardello-Petersen R, Siemieniuk RAC, Zeraatkar D, Akl EA, Armijo-Olivo S, Bassler D, Gamble C, Gluud LL, Hutton JL, Letelier LM, Ravaud P, Schulz KF, Torgerson DJ, Guyatt GH. Development of ROBUSTRCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials. BMJ. 2025;388:e081199. doi: 10.1136/bmj-2024-081199.
Questions, suggestions and collaborations are welcome.
Contact Ying Wang: yingwwy@163.com