Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials

Ying Wang; Sheri Keitz; Matthias Briel; Paul Glasziou; Romina Brignardello-Petersen; Reed A C Siemieniuk; Dena Zeraatkar; Elie A Akl; Susan Armijo-Olivo; Dirk Bassler; Carrol Gamble; Lise Lotte Gluud; Jane Luise Hutton; Luz M Letelier; Philippe Ravaud; Kenneth F Schulz; David J Torgerson; Gordon H Guyatt

doi:10.1136/bmj-2024-081199

Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials

Ying Wang^*, Sheri Keitz, Matthias Briel, Paul Glasziou, Romina Brignardello-Petersen, Reed A C Siemieniuk, Dena Zeraatkar, Elie A Akl, Susan Armijo-Olivo, Dirk Bassler, Carrol Gamble, Lise Lotte Gluud, Jane Luise Hutton, Luz M Letelier, Philippe Ravaud, Kenneth F Schulz, David J Torgerson, Gordon H Guyatt

^*Corresponding author for this work

Institute for Evidence-Based Healthcare

Research output: Contribution to journal › Article › Research › peer-review

Abstract

Recent innovations in evidence based medicine methods, in particular instruments assessing risk of bias in randomised trials, have focused on methodological rigour at the expense of simplicity and practicability. Such a focus could lead to challenges in application and loss of reliability of instruments. To deal with these shortcomings, the Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials (ROBUST-RCT) was created—a rigorously developed, simply structured, and user friendly instrument for assessing risk of bias of randomised controlled trials included in systematic reviews. This paper describes the development of ROBUST-RCT and provides associated documents and a manual of instructions.

Original language	English
Article number	e081199
Journal	BMJ (Clinical research ed.)
Volume	388
DOIs	https://doi.org/10.1136/bmj-2024-081199
Publication status	Published - 25 Mar 2025

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Wang, Y., Keitz, S., Briel, M., Glasziou, P., Brignardello-Petersen, R., Siemieniuk, R. A. C., Zeraatkar, D., Akl, E. A., Armijo-Olivo, S., Bassler, D., Gamble, C., Gluud, L. L., Hutton, J. L., Letelier, L. M., Ravaud, P., Schulz, K. F., Torgerson, D. J., & Guyatt, G. H. (2025). Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials. BMJ (Clinical research ed.), 388, Article e081199. https://doi.org/10.1136/bmj-2024-081199

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title = "Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials",

abstract = "Recent innovations in evidence based medicine methods, in particular instruments assessing risk of bias in randomised trials, have focused on methodological rigour at the expense of simplicity and practicability. Such a focus could lead to challenges in application and loss of reliability of instruments. To deal with these shortcomings, the Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials (ROBUST-RCT) was created—a rigorously developed, simply structured, and user friendly instrument for assessing risk of bias of randomised controlled trials included in systematic reviews. This paper describes the development of ROBUST-RCT and provides associated documents and a manual of instructions.",

author = "Ying Wang and Sheri Keitz and Matthias Briel and Paul Glasziou and Romina Brignardello-Petersen and Siemieniuk, {Reed A C} and Dena Zeraatkar and Akl, {Elie A} and Susan Armijo-Olivo and Dirk Bassler and Carrol Gamble and Gluud, {Lise Lotte} and Hutton, {Jane Luise} and Letelier, {Luz M} and Philippe Ravaud and Schulz, {Kenneth F} and Torgerson, {David J} and Guyatt, {Gordon H}",

year = "2025",

month = mar,

day = "25",

doi = "10.1136/bmj-2024-081199",

language = "English",

volume = "388",

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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 2025, 'Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials', BMJ (Clinical research ed.), vol. 388, e081199. https://doi.org/10.1136/bmj-2024-081199

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AU - Wang, Ying

AU - Keitz, Sheri

AU - Briel, Matthias

AU - Glasziou, Paul

AU - Brignardello-Petersen, Romina

AU - Siemieniuk, Reed A C

AU - Zeraatkar, Dena

AU - Akl, Elie A

AU - Armijo-Olivo, Susan

AU - Bassler, Dirk

AU - Gamble, Carrol

AU - Gluud, Lise Lotte

AU - Hutton, Jane Luise

AU - Letelier, Luz M

AU - Ravaud, Philippe

AU - Schulz, Kenneth F

AU - Torgerson, David J

AU - Guyatt, Gordon H

PY - 2025/3/25

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AB - Recent innovations in evidence based medicine methods, in particular instruments assessing risk of bias in randomised trials, have focused on methodological rigour at the expense of simplicity and practicability. Such a focus could lead to challenges in application and loss of reliability of instruments. To deal with these shortcomings, the Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials (ROBUST-RCT) was created—a rigorously developed, simply structured, and user friendly instrument for assessing risk of bias of randomised controlled trials included in systematic reviews. This paper describes the development of ROBUST-RCT and provides associated documents and a manual of instructions.

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Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials

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