The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

By David Moher, K. F. Schulz, Douglas G. Altman. Annals of Internal Medicine, 2001

3,748 citations recorded by the source corpus.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement.The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis.In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Subfields: Economics and Econometrics, Public Health, Environmental and Occupational Health, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/ea27bb33e2897cdea5f1c7a7dda41d710cecc08a

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Citations in the corpus

Effectiveness of school-based programs to reduce bullying: a systematic and meta-analytic review (2011, background): “Future reports should provide key information about features of evaluations, according to a checklist that should be developed, inspired perhaps by the CONSORT Statement for medical research (see Altman et al. 2001; Moher et al. 2001; Perry and Johnson 2008).”
On the Plurality of (Methodological) Worlds: Estimating the Analytic Flexibility of fMRI Experiments (2012, background): “Such guidelines, which have been widely adopted by academic journals that publish studies of randomized controlled trials (Moher et al., 2001), diagnostic accuracy (Bossuyt et al., 2003), and observational epidemiology (von Elm et al., 2007), can significantly improve the quality of methods…”
Parametric versus non-parametric statistics in the analysis of randomized trials with non-normally distributed data (2005, neutral): “results should not be re ported solely as p-values" [17].”
Lower protein in infant formula is associated with lower weight up to age 2 y: a randomized clinical trial. (2009, methodology): “The study followed the recommendations made in the CONSORT guidelines (26).”
Systematic evaluation of observational methods assessing biomechanical exposures at work. (2010, positive): “Future development and evaluation of methods would probably benefit from a set of guidelines on “minimal requirements for reporting”, similar to those adopted for clinical trials (146) and epidemiological studies (147).”
RAMESES II reporting standards for realist evaluations (2016, background): “Within health services research, reporting standards are common and increasingly expected (for example, [14–16]).”
Social psychological factors in lifestyle change and their relevance to policy (2007, background): “Acceptance of this statement has helped standardize reporting of intervention evaluations by insisting that researchers provide “precise details of the interventions intended for each group and how and when they were actually administered” (Moher et al., 2001, p. 1192).”
Mind The Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation (2017, neutral): “Despite CONSORT requirements (Moher et al., 2001), and compared to 100% of pharmacology trials (Vaughan, Goldstein, Alikakos, Cohen, & Serby, 2014), less than 25% of meditation trials actively assess AEs (Goyal et al., 2014; Jonsson, Alaie, Parling, & Arnberg, 2014), relying instead on spontaneous…”
Methodological quality (risk of bias) assessment tools for primary and secondary medical studies: what are they and which is better? (2020, methodology): “Of them, someone used the reporting checklist to assess the methodological quality, such as used the Consolidated Standards of Reporting Trials (CONSORT) statement [103] to assess methodological quality of RCT, used the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) st”
Why Most Published Research Findings Are False (2005, neutral): “, randomized controlled trials [18–20] or meta-analyses [21,22], there have been efforts to standardize their conduct and reporting.”