TY - JOUR

T1 - Instruments assessing risk of bias of randomized trials frequently included items that are not addressing risk of bias issues

AU - Wang, Ying

AU - Ghadimi, Maryam

AU - Wang, Qi

AU - Hou, Liangying

AU - Zeraatkar, Dena

AU - Iqbal, Atiya

AU - Ho, Cameron

AU - Yao, Liang

AU - Hu, Malini

AU - Ye, Zhikang

AU - Couban, Rachel

AU - Armijo-Olivo, Susan

AU - Bassler, Dirk

AU - Briel, Matthias

AU - Gluud, Lise Lotte

AU - Glasziou, Paul

AU - Jackson, Rod

AU - Keitz, Sheri A.

AU - Letelier, Luz M.

AU - Ravaud, Philippe

AU - Schulz, Kenneth F.

AU - Siemieniuk, Reed A.C.

AU - Brignardello-Petersen, Romina

AU - Guyatt, Gordon H.

N1 - Publisher Copyright: © 2022 Elsevier Inc.

PY - 2022

Y1 - 2022

N2 - Objectives: To establish whether items included in instruments published in the last decade assessing risk of bias of randomized controlled trials (RCTs) are indeed addressing risk of bias. Study Design and Setting: We searched Medline, Embase, Web of Science, and Scopus from 2010 to October 2021 for instruments assessing risk of bias of RCTs. By extracting items and summarizing their essential content, we generated an item list. Items that two reviewers agreed clearly did not address risk of bias were excluded. We included the remaining items in a survey in which 13 experts judged the issue each item is addressing: risk of bias, applicability, random error, reporting quality, or none of the above. Results: Seventeen eligible instruments included 127 unique items. After excluding 61 items deemed as clearly not addressing risk of bias, the item classification survey included 66 items, of which the majority of respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items. Conclusion: Existing risk of bias instruments frequently include items that do not address risk of bias. For many items, experts disagree on whether or not they are addressing risk of bias.

AB - Objectives: To establish whether items included in instruments published in the last decade assessing risk of bias of randomized controlled trials (RCTs) are indeed addressing risk of bias. Study Design and Setting: We searched Medline, Embase, Web of Science, and Scopus from 2010 to October 2021 for instruments assessing risk of bias of RCTs. By extracting items and summarizing their essential content, we generated an item list. Items that two reviewers agreed clearly did not address risk of bias were excluded. We included the remaining items in a survey in which 13 experts judged the issue each item is addressing: risk of bias, applicability, random error, reporting quality, or none of the above. Results: Seventeen eligible instruments included 127 unique items. After excluding 61 items deemed as clearly not addressing risk of bias, the item classification survey included 66 items, of which the majority of respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items. Conclusion: Existing risk of bias instruments frequently include items that do not address risk of bias. For many items, experts disagree on whether or not they are addressing risk of bias.

KW - Instrument

KW - Methodological quality

KW - Randomized controlled trials

KW - Risk of bias

KW - Systematic reviews

KW - Systematic survey

U2 - 10.1016/j.jclinepi.2022.10.018

DO - 10.1016/j.jclinepi.2022.10.018

M3 - Journal article

C2 - 36424692

AN - SCOPUS:85142200952

VL - 152

SP - 218

EP - 225

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -