CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials

By K. F. Schulz, Douglas G. Altman, David Moher. Obstetrics and Gynecology, 2010

3,909 citations recorded by the source corpus.

Randomized controlled trials (RCTs), when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions. That lofty position in the medical research hierarchy does not mean, however, that readers should uncritically accept the results of all RCTs. Indeed, randomized trials can yield biased results if they lack methodological rigor. (1) To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information. (2-4) That lack of adequate reporting fueled the development of the original CONSORT (Consolidated Standards of Reporting Trials) Statement in 1996 (5) and its revision five years later. (6-8) While those Statements positively impacted reporting quality for some RCTs, (9) (10) many trial reports still remain inadequate. (2) Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organized a CONSORT Group meeting to update the 2001 Statement. (6-8) We introduce here the result of that process, CONSORT 2010.

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

View Paper: https://www.semanticscholar.org/paper/b9c81077f198e32dc6a3f45696db278781ae7822

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

In Economics and Econometrics

1. David Moher
2. Douglas G. Altman
3. J. Gagnier
4. H. Sox
5. G. Kienle
6. David Riley
7. C. Gluud
8. E. Loder

In Public Health, Environmental and Occupational Health

1. David Moher
2. Douglas G. Altman
3. H. Sox
4. J. Gagnier
5. G. Kienle
6. David Riley
7. Mark D. Griffiths
8. G. Dobos

In Statistics and Probability

1. Douglas G. Altman
2. David Moher
3. C. Gluud
4. J. Gagnier
5. J. Jakobsen
6. H. Sox
7. G. Kienle
8. David Riley

Citations in the corpus

• Are Health Behavior Change Interventions That Use Online Social Networks Effective? A Systematic Review (2014, methodology): “After extensive discussion among the research team, a tool was devised based upon the CONSORT checklist [17].”
• International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma (2013, background): “Further well designed and rigorously executed randomized trials that measure and properly report [252, 253] patientimportant outcomes are needed, as are studies of patients identified to have an eosinophilic phenotype.”
• Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. (2013, methodology): “, Consolidated Standards of Reporting Trials, CONSORT for randomized trials [27]; Strengthening the Reporting of Observational Studies in Epidemiology, STROBE for observational studies [67]).”
• Interventions for increasing the use of shared decision making by healthcare professionals. (2018, methodology): “Authors should report the methods and results of their trials in more detail by following reporting guidelines more strictly (Campbell 2012; Schulz 2010).”
• Effects of psycho-oncologic interventions on emotional distress and quality of life in adult patients with cancer: systematic review and meta-analysis. (2013, methodology): “Detailed reporting according to the requirements presented by the CONSORT statement will make it easier to reach clear conclusions regarding study quality.(62) Although there are some clear limitations regarding the body of research reviewed in this study, a tentative conclusion can be reached, that”
• A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results (2015, methodology): “Background Appropriately designed and executed randomized controlled trials (RCTs) represent the current gold-standard primary study design for the determination of the efficacy and safety of medical interventions [1].”
• YOGA FOR DEPRESSION: A SYSTEMATIC REVIEW AND META‐ANALYSIS (2013, methodology): “Future RCTs should ensure rigorous methodology and reporting, mainly adequate sample size, adequate randomization, allocation concealment, intention-to-treat analysis, and blinding of at least outcome assessors.[96] As exercise seems to be an effective means to improve depressive symptoms in depress”