ArticleJournal of clinical epidemiology2023
Methodology reporting improved over time in 176,469 randomized controlled trials.
Article in Journal of clinical epidemiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Large Language Model Analysis of Reporting Quality of Randomized Clinical Trial Articles: A Systematic Review.JAMA network open · 2025Pooled it
- SPIRIT-CONSORT-ELM: Element-Level Annotated Dataset and Large Language Model Approach for Assessing Randomized Controlled Trial Reporting.medRxiv : the preprint server for health sciences · 2026Article
- Can artificial intelligence accurately assess systematic review quality? Benchmarking large language models for AMSTAR 2 appraisal in dental evidence synthesis.Evidence-based dentistry · 2026Article
- What influences whether researchers adhere to healthcare reporting guidelines successfully? A thematic synthesis.Research integrity and peer review · 2026Article
- CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.BMJ (Clinical research ed.) · 2025Article
- SPIRIT-CONSORT-TM: a corpus for assessing transparency of clinical trial protocol and results publications.Scientific data · 2025Article
- SPIRIT-CONSORT-TM: a corpus for assessing transparency of clinical trial protocol and results publications.medRxiv : the preprint server for health sciences · 2025Article
- Text classification models for assessing the completeness of randomized controlled trial publications based on CONSORT reporting guidelines.Scientific reports · 2024Article
- Automatic categorization of self-acknowledged limitations in randomized controlled trial publications.Journal of biomedical informatics · 2024Article
- CONSORT-TM: Text classification models for assessing the completeness of randomized controlled trial publications.medRxiv : the preprint server for health sciences · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectivesTo describe randomized controlled trial (RCT) methodology reporting over time. STUDY DESIGN AND
settingWe used a deep learning-based sentence classification model based on the Consolidated Standards of Reporting Trials (CONSORT) statement, considered minimum requirements for reporting RCTs. We included 176,469 RCT reports published between 1966 and 2018. We analyzed the reporting trends over 5-year time periods, grouping trials from 1966 to 1990 in a single stratum. We also explored the effect of journal impact factor (JIF) and medical discipline.
resultsPopulation, Intervention, Comparator, Outcome (PICO) items were commonly reported during each period, and reporting increased over time (e.g., interventions: 79.1% during 1966-1990 to 87.5% during 2010-2018). Reporting of some methods information has increased, although there is room for improvement (e.g., sequence generation: 10.8-41.8%). Some items are reported infrequently (e.g., allocation concealment: 5.1-19.3%). The number of items reported and JIF are weakly correlated (Pearson's r (162,702) = 0.16, P < 0.001). The differences in the proportion of items reported between disciplines are small (<10%).
conclusionOur analysis provides large-scale quantitative support for the hypothesis that RCT methodology reporting has improved over time. Extending these models to all CONSORT items could facilitate compliance checking during manuscript authoring and peer review, and support metaresearch.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.