Machine learning to help researchers evaluate biases in clinical trials: a prospective, randomized user study

Objective Assessing risks of bias in randomized controlled trials (RCTs) is an important but laborious task when conducting systematic reviews. RobotReviewer (RR), an open-source machine learning (ML) system, semi-automates bias assessments. We conducted a user study of RobotReviewer, evaluating time saved and usability of the tool. Materials and methods Systematic reviewers applied the Cochrane Risk of Bias tool to four randomly selected RCT articles. Reviewers judged: whether an RCT was at low, or high/unclear risk of bias for each bias domain in the Cochrane tool (Version 1); and highlighted article text justifying their decision. For a random two of the four articles, the process was semi-automated: users were provided with ML-suggested bias judgments and text highlights. Participants could amend the suggestions if necessary. We measured time taken for the task, ML suggestions, usability via the System Usability Scale (SUS) and collected qualitative feedback. Results For 41 volunteers, semi-automation was quicker than manual assessment (mean 755 vs. 824 s; relative time 0.75, 95% CI 0.62–0.92). Reviewers accepted 301/328 (91%) of the ML Risk of Bias (RoB) judgments, and 202/328 (62%) of text highlights without change. Overall, ML suggested text highlights had a recall of 0.90 (SD 0.14) and precision of 0.87 (SD 0.21) with respect to the users’ final versions. Reviewers assigned the system a mean 77.7 SUS score, corresponding to a rating between “good” and “excellent”. Conclusions Semi-automation (where humans validate machine learning suggestions) can improve the efficiency of evidence synthesis. Our system was rated highly usable, and expedited bias assessment of RCTs.