Work

Evaluation of methodology, reporting and transparency of 50 highly cited randomised trials in neurology: a cross-sectional analysis

Year: 2026

Type: article

Abstract: Background Highly cited randomised controlled trials (RCTs) have a high impact on medical decision making. However, their quality has not been systematically evaluated. This cross-sectional study evaluates the methodological and reporting quality, and aspects of transparency of 50 highly cited RCTs in the field of neurology published between 2018 and 2022. Methods We searched Web of Science to identify the 10 most-cited neurology RCTs per year from 2018 to 2022. Methodological quality was assessed using the Revised Cochrane Risk-of-Bias tool (RoB 2), and reporting quality was evaluated based on the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement. Additionally, we analysed data sharing statements, document availability and trial registration details according to current recommendations and regulations. Two independent reviewers evaluated each study. Results Included studies were mostly multicentred multinational (36/50) RCTs; 25/50 investigated stroke. We rated 16% (8/50) as low risk of bias, 72% (36/50) with some concerns and 12% (6/50) as high risk. Reporting quality was generally adequate for intervention description and primary outcome analysis (>80% reported), but lacked detail on randomisation and trial design (<50% reported). Data sharing statements were provided in 36/50 publications. Most RCTs provided protocol (48/50) and statistical analysis plan (46/50) while analytic code was rarely available (8/50) for most publications. Most studies were prospectively registered (41/50). Yet, only a minority (18/50) documented results in the registry within 12 months. Conclusions Most studies had some concerns in risk of bias evaluation and a generally acceptable reporting quality. However, quality of methods reporting, results documentation in registries and analytic code access need improvement. Trial registration Open Science Framework (OSF) (DOI 10.17605/OSF.IO/4RV7A).

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-117895

Authors: Alexander Benkendorff, Elida Sina, Anneke Clara Bergt, Julia Stadelmaier, Joerg J Meerpohl

Institutions: University of Freiburg, University Medical Center Freiburg, Cochrane Deutschland Stiftung, Cochrane

Language: English

Topic: Meta-analysis and systematic reviews

Subfield: Statistics, Probability and Uncertainty

Field: Decision Sciences

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,839