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Consolidated Standards of Reporting Trials

May 04, 2023

CONSORT (Consolidated Standards Of Reporting Trials) 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.

The 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]), and various types of intervention (e.g., herbals,[8] non-pharmacologic treatments,[9] acupuncture[10]). A number of guidelines have been designed to complement CONSORT, including TIDieR (encouraging adequate descriptions of interventions) [11] and TIDieR-Placebo (encouraging adequate descriptions of placebo or sham controls).[12] 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,[13] 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.[14]

At the suggestion of Dr. Drummond Rennie, from JAMA,[15] 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.[16] Further meetings of the CONSORT Group in 1999 and 2000 led to the publication of the revised CONSORT Statement in 2001.[17]

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.[18]

A 2006 systematic review suggest that use of the CONSORT checklist is associated with improved reporting of randomized trials.[19]

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),[20] Standards for the Reporting of Diagnostic Accuracy Studies (STARD),[21] Strengthening the Reporting of Genetic Association studies (STREGA),[22] Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA),[23] Standards for Quality Improvement Reporting Excellence (SQUIRE),[24] among others. These reporting guidelines have been incorporated into the EQUATOR Network initiative to enhance the transparent and accurate reporting of research studies.[25]

See also

References

  1. ^ a b c 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. ^ a b c 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. [1]
  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. [2]
  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. [3]
  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. [4]
  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. [5]
  8. ^ 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. [6]
  9. ^ 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. [7]
  10. ^ 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 [8]
  11. ^ 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 [9]
  12. ^ 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. [10]
  13. ^ 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.
  14. ^ 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.
  15. ^ Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers. JAMA 1995; 273(13):1054-1055.
  16. ^ 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.
  17. ^ 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. [11]
  18. ^ 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.
  19. ^ 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.
  20. ^ Vandenbroucke JP. The making of STROBE. Epidemiology 2007;18: 797e9.
  21. ^ Knottnerus JA, Tugwell P. The standards for reporting of diagnostic accuracy. J Clin Epidemiol 2003;56:1118e27
  22. ^ 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
  23. ^ 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
  24. ^ 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
  25. ^ 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

External links

  • CONSORT Statement website

May 04, 2023
consolidated, standards, reporting, trials, consort, consolidated, standards, reporting, trials, encompasses, various, initiatives, developed, consort, group, alleviate, problems, arising, from, inadequate, reporting, randomized, controlled, trials, part, larg. CONSORT Consolidated Standards Of Reporting Trials 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 1 The CONSORT Statement 1 1 Extensions 2 History 3 Impact 4 See also 5 References 6 External linksThe CONSORT Statement EditThe 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 Edit 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 and various types of intervention e g herbals 8 non pharmacologic treatments 9 acupuncture 10 A number of guidelines have been designed to complement CONSORT including TIDieR encouraging adequate descriptions of interventions 11 and TIDieR Placebo encouraging adequate descriptions of placebo or sham controls 12 This list is by no means exhaustive and work is ongoing History EditIn 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 13 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 14 At the suggestion of Dr Drummond Rennie from JAMA 15 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 16 Further meetings of the CONSORT Group in 1999 and 2000 led to the publication of the revised CONSORT Statement in 2001 17 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 EditThe 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 18 A 2006 systematic review suggest that use of the CONSORT checklist is associated with improved reporting of randomized trials 19 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 20 Standards for the Reporting of Diagnostic Accuracy Studies STARD 21 Strengthening the Reporting of Genetic Association studies STREGA 22 Preferred Reporting Items for Systematic Reviews and Meta Analyses PRISMA 23 Standards for Quality Improvement Reporting Excellence SQUIRE 24 among others These reporting guidelines have been incorporated into the EQUATOR Network initiative to enhance the transparent and accurate reporting of research studies 25 See also EditMetascience STROBEReferences Edit a b c Schulz KF Altman DG Moher D CONSORT Group CONSORT 2010 statement updated guidelines for reporting parallel group randomised trials BMJ 2010 Mar23 340 c332 a b c Moher D Hopewell S Schulz KF Montori V Gotzsche 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 Campbell MK Elbourne DR Altman DG CONSORT statement extension to cluster randomised trials BMJ 2004 328 7441 702 708 1 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 2 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 3 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 4 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 5 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 6 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 7 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 8 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 9 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 10 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 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 Rennie D Reporting randomized controlled trials An experiment and a call for responses from readers JAMA 1995 273 13 1054 1055 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 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 11 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 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 Vandenbroucke JP The making of STROBE Epidemiology 2007 18 797e9 Knottnerus JA Tugwell P The standards for reporting of diagnostic accuracy J Clin Epidemiol 2003 56 1118e27 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 Liberati A Altman DG Tetzlaff J Mulrow C Gotzsche 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 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 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 87External links EditCONSORT Statement website Retrieved from https en wikipedia org w index php title Consolidated Standards of Reporting Trials amp oldid 1118575652, wikipedia, wiki, book, books, library,

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