Consolidated Standards of Reporting Trials

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Consolidated Standards of Reporting Trials (CONSORT) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials. It is part of the larger EQUATOR Network initiative to enhance the transparency and accuracy of reporting in research.

Contents

CONSORT Statement

The main product of the CONSORT Group is the CONSORT Statement, [1] which is an evidence-based, minimum set of recommendations for reporting randomized trials. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.

The most recent version of the Statement—the CONSORT 2010 Statement—consists of a 25-item checklist and a participant flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial. The Statement has been translated into several languages.

The CONSORT "Explanation and Elaboration" document [2] explains and illustrates the principles underlying the CONSORT Statement. It is strongly recommended that it be used in conjunction with the CONSORT Statement. [1]

Considered an evolving document, [2] the CONSORT Statement is subject to periodic changes as new evidence emerges; the most recent update was published in March 2010. The current definitive version of the CONSORT Statement and up-to-date information on extensions are placed on the CONSORT website.

Extensions

The main CONSORT Statement is based on the "standard" two-group parallel design. Extensions of the CONSORT Statement have been developed to give additional guidance for randomized trials with specific designs (e.g., cluster randomized trials, [3] noninferiority and equivalence trials, [4] pragmatic trials [5] ), data (e.g., harms, [6] abstracts [7] ), type of target outcome, [8] and various types of intervention (e.g., herbals, [9] non-pharmacologic treatments, [10] acupuncture [11] ). A number of guidelines have been designed to complement CONSORT, including TIDieR (encouraging adequate descriptions of interventions) [12] and TIDieR-Placebo (encouraging adequate descriptions of placebo or sham controls). [13] This list is by no means exhaustive, and work is ongoing.

History

In 1993, 30 experts—medical journal editors, clinical trialists, epidemiologists, and methodologists—met in Ottawa, Canada to discuss ways of improving the reporting of randomized trials. This meeting resulted in the Standardized Reporting of Trials (SORT) statement, [14] a 32-item checklist and flow diagram in which investigators were encouraged to report on how randomized trials were conducted.

Concurrently, and independently, another group of experts, the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, convened in California, USA, and were working on a similar mandate. This group also published recommendations for authors reporting randomized trials. [15]

At the suggestion of Dr. Drummond Rennie, from JAMA, [16] in 1995 representatives from both these groups met in Chicago, USA, with the aim of merging the best of the SORT and Asilomar proposals into a single, coherent evidence-based recommendation. This resulted in the Consolidated Standards of Reporting Trials (CONSORT) Statement, which was first published in 1996. [17] Further meetings of the CONSORT Group in 1999 and 2000 led to the publication of the revised CONSORT Statement in 2001. [18]

Since the revision in 2001, the evidence base to inform CONSORT has grown considerably; empirical data highlighting new concerns regarding the reporting of randomized trials. Therefore, a third CONSORT Group meeting was held in 2007, resulting in publication of a newly revised CONSORT Statement [1] and explanatory document [2] in 2010. Users of the guideline are strongly recommended to refer to the most up-to-date version while writing or interpreting reports of clinical trials.

Impact

The CONSORT Statement has gained considerable support since its inception in 1996. Over 600 journals and editorial groups worldwide now endorse it, including The Lancet, BMJ, JAMA, New England Journal of Medicine, World Association of Medical Editors, and International Committee of Medical Journal Editors. The 2001 revised Statement has been cited over 1,200 times and the accompanying explanatory document over 500 times. Another indication of CONSORT's impact is reflected in the approximately 17,500 hits per month that the CONSORT website has received. It has also recently been published as a book for those involved in the planning, conducting and interpretation of clinical trials. [19]

A 2006 systematic review suggest that use of the CONSORT checklist is associated with improved reporting of randomized trials. [20]

Similar initiatives to improve the reporting of other types of research have arisen after the introduction of CONSORT. They include: Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), [21] Standards for the Reporting of Diagnostic Accuracy Studies (STARD), [22] Strengthening the Reporting of Genetic Association studies (STREGA), [23] Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), [24] Transparent Reporting of a multivariable model for Individual Prognosis Or Diagnosis (TRIPOD+AI), [25] Standards for Quality Improvement Reporting Excellence (SQUIRE), [26] among others. These reporting guidelines have been incorporated into the EQUATOR Network initiative to enhance the transparent and accurate reporting of research studies. [27]

See also

Related Research Articles

<span class="mw-page-title-main">Randomized controlled trial</span> Form of scientific experiment

A randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments.

In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints.

In clinical trials, a surrogate endpoint is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint".

A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose

  1. Results in death
  2. Is life-threatening
  3. Requires inpatient hospitalization or causes prolongation of existing hospitalization
  4. Results in persistent or significant disability/incapacity
  5. May have caused a congenital anomaly/birth defect
  6. Requires intervention to prevent permanent impairment or damage

In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes.

In a randomized experiment, allocation concealment hides the sorting of trial participants into treatment groups so that this knowledge cannot be exploited. Adequate allocation concealment serves to prevent study participants from influencing treatment allocations for subjects. Studies with poor allocation concealment are prone to selection bias.

<span class="mw-page-title-main">Risk difference</span>

The risk difference (RD), excess risk, or attributable risk is the difference between the risk of an outcome in the exposed group and the unexposed group. It is computed as , where is the incidence in the exposed group, and is the incidence in the unexposed group. If the risk of an outcome is increased by the exposure, the term absolute risk increase (ARI) is used, and computed as . Equivalently, if the risk of an outcome is decreased by the exposure, the term absolute risk reduction (ARR) is used, and computed as .

<span class="mw-page-title-main">Doug Altman</span> English statistician (1948–2018)

Douglas Graham Altman FMedSci was an English statistician best known for his work on improving the reliability and reporting of medical research and for highly cited papers on statistical methodology. He was professor of statistics in medicine at the University of Oxford, founder and Director of Centre for Statistics in Medicine and Cancer Research UK Medical Statistics Group, and co-founder of the international Equator Network for health research reliability.

A clinical prediction rule or clinical probability assessment specifies how to use medical signs, symptoms, and other findings to estimate the probability of a specific disease or clinical outcome.

The STROBE(STrengthening the Reporting of OBservational studies in Epidemiology) Statement is a reporting guideline including a checklist of 22 items that are considered essential for good reporting of observational studies. It was published simultaneously in several leading biomedical journals in October and November 2007 and comprises both the checklist and an explanation and elaboration article which gives examples of good reporting and provides authors with more guidance on good reporting. It is also referred to in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals established by the International Committee of Medical Journal Editors and is endorsed by hundreds of biomedical journals.

The Jadad scale, sometimes known as Jadad scoring or the Oxford quality scoring system, is a procedure to assess the methodological quality of a clinical trial by objective criteria. It is named after Canadian-Colombian physician Alex Jadad who in 1996 described a system for allocating such trials a score of between zero and five (rigorous). It is the most widely used such assessment in the world, and as of May 2024, its seminal paper has been cited in over 24,500 scientific works.

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A cluster-randomised controlled trial is a type of randomised controlled trial in which groups of subjects are randomised. Cluster randomised controlled trials are also known as cluster-randomised trials, group-randomised trials, and place-randomized trials. Cluster-randomised controlled trials are used when there is a strong reason for randomising treatment and control groups over randomising participants.

The Enhancing the Quality and Transparency of health research Network is an international initiative aimed at promoting transparent and accurate reporting of health research studies to enhance the value and reliability of medical research literature. The EQUATOR Network is hosted by the University of Oxford, and was established with the goals of raising awareness of the importance of good reporting of research, assisting in the development, dissemination and implementation of reporting guidelines for different types of study designs, monitoring the status of the quality of reporting of research studies in the health sciences literature, and conducting research relating to issues that impact the quality of reporting of health research studies. The Network acts as an "umbrella" organisation, bringing together developers of reporting guidelines, medical journal editors and peer reviewers, research funding bodies, and other key stakeholders with a mutual interest in improving the quality of research publications and research itself. The EQUATOR Network comprises five centres at the University of Oxford, Bond University, Paris Descartes University, Ottawa Hospital Research Institute, and Hong Kong Baptiste University.

<span class="mw-page-title-main">Preferred Reporting Items for Systematic Reviews and Meta-Analyses</span> Scientific reporting standard

PRISMA is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care intervention. PRISMA focuses on ways in which authors can ensure a transparent and complete reporting of this type of research. The PRISMA standard superseded the earlier QUOROM standard. It offers the replicability of a systematic literature review. Researchers have to figure out research objectives that answer the research question, states the keywords, a set of exclusion and inclusion criteria. In the review stage, relevant articles were searched, irrelevant ones are removed. Articles are analyzed according to some pre-defined categories.

Isabelle Boutron is a professor of epidemiology at the Université Paris Cité and head of the INSERM- METHODS team within the Centre of Research in Epidemiology and Statistics (CRESS). She was originally trained in rheumatology and later switched to a career in epidemiology and public health. She is also deputy director of the French EQUATOR Centre, member of the SPIRIT-CONSORT executive committee, director of Cochrane France and co-convenor of the Bias Methods group of the Cochrane Collaboration.

Allegiance bias in behavioral sciences is a bias resulted from the investigator's or researcher's allegiance to a specific school of thought. Researchers/investigators have been exposed to many types of branches of psychology or schools of thought. Naturally they adopt a school or branch that fits with their paradigm of thinking. More specifically, allegiance bias is when this leads therapists, researchers, etc. believing that their school of thought or treatment is superior to others. Their superior belief to these certain schools of thought can bias their research in effective treatments trials or investigative situations leading to allegiance bias. Reason being is that they may have devoted their thinking to certain treatments they have seen work in their past experiences. This can lead to errors in interpreting the results of their research. Their “pledge” to stay within their own paradigm of thinking may affect their ability to find more effective treatments to help the patient or situation they are investigating.

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non-pharmacological intervention (NPI) is any type of healthcare intervention which is not primarily based on medication. Some examples include exercise, sleep improvement, and dietary habits.

Outcome switching is the practice of changing the primary or secondary outcomes of a clinical trial after its initiation. An outcome is the goal of the clinical trial, such as survival after five years for cancer treatment. Outcome switching can lead to bias and undermine the reliability of the trial, for instance when outcomes are switched after researchers already have access to trial data. That way, researchers can cherry pick an outcome which is statistically significant.

References

  1. 1 2 3 Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar23;340:c332
  2. 1 2 3 Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869
  3. ↑ Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328(7441):702-708. Archived 2012-03-04 at the Wayback Machine
  4. ↑ Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 2006; 295:1152-1160. Archived 2012-03-04 at the Wayback Machine
  5. ↑ Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D for the CONSORT and Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337;a2390. Archived 2012-03-09 at the Wayback Machine
  6. ↑ Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141(10):781-788. Archived 2012-03-04 at the Wayback Machine
  7. ↑ Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF and the CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 2008 5(1): e20. Archived 2012-05-11 at the Wayback Machine
  8. ↑ Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Blazeby J, Butcher NJ, Bujkiewicz S, Chan AW, Dawoud D, Offringa M, Ouwens M, Hróbjartssson A, Amstutz A, Bertolaccini L, Bruno VD, Devane D, Faria CDCM, Gilbert PB, Harris R, Lassere M, Marinelli L, Markham S, Powers JH 3rd, Rezaei Y, Richert L, Schwendicke F, Tereshchenko LG, Thoma A, Turan A, Worrall A, Christensen R, Collins GS, Ross JS, Taylor RS, Ciani O. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. BMJ 2024 Jul 9:386:e078524. doi : 10.1136/bmj-2023-078524
  9. ↑ Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006; 144(5):364-367. Archived 2012-03-04 at the Wayback Machine
  10. ↑ Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT Group. Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008: 148(4):295-309. Archived 2012-03-04 at the Wayback Machine
  11. ↑ MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010 Jun 8;7(6):e1000261 Archived 2012-03-09 at the Wayback Machine
  12. ↑ Hoffmann M, Glasziou P, Milne R, Moher D, Barbour V, Johnston M, Lamb SE, Dixon-Woods M, Wyatt JC. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687
  13. ↑ Howick J, Webster RK, Rees JL, Turner R, Macdonald H, Price A, Evers AWM, Bishop F, Collins GS, Bokelmann K, Hopewell S, Knottnerus A, Lamb S, Madigan C, Napadow V, Papanikitas AN, Hoffmann T. TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. PLOS Medicine 17(9): e1003294. https://doi.org/10.1371/journal.pmed.1003294.
  14. ↑ The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994; 272(24):1926-1931.
  15. ↑ Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med. 1994; 121(11):894-895.
  16. ↑ Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers. JAMA 1995; 273(13):1054-1055.
  17. ↑ Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276(8):637-639.
  18. ↑ Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials . Ann Intern Med 2001; 134(8):657-662. Archived 2012-03-04 at the Wayback Machine
  19. ↑ Keech A, Gebski VJ, Pike R. Interpreting and reporting clinical trials. A guide to the CONSORT Statement and the principles of randomised controlled trials. 2007: Australasian Medical Publishing: NSW, Australia.
  20. ↑ Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006; 185(5):263-267.
  21. ↑ Vandenbroucke JP. The making of STROBE. Epidemiology 2007;18: 797e9.
  22. ↑ Knottnerus JA, Tugwell P. The standards for reporting of diagnostic accuracy. J Clin Epidemiol 2003;56:1118e27
  23. ↑ Little J, Higgins JPT, Ioannidis JPA, Moher D, Gagnon F, Von Elm E, et al. STrengthening the REporting of Genetic Association studies (STREGA)-an extension of the STROBE Statement. J Clin Epidemiol 2009;62:597e608
  24. ↑ Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche P, et al. and the PRISMA Group (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. PLoS Med 6: e1000100. doi : 10.1371/journal.pmed.1000100
  25. ↑ Collins, Gary; et al. (2024-04-16). "TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods". BMJ . doi:10.1136/bmj-2023-078378. PMC   11019967 . PMID   38626948.
  26. ↑ Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S, SQUIRE Development Group. Publication guidelines for improvement studies in health care: evolution of the SQUIRE Project. Ann Intern Med 2008;149:670e6
  27. ↑ Simera I, Altman DG, Moher D, Schulz K, Hoey J. The EQUATOR Network: facilitating transparent and accurate reporting of health research. Serials 2008 Nov 21 (3): 183-87
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