Guidance for reporting experimental studies

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Reporting guidance provided for: Name of guideline website (where available) References including PMID
Randomised controlled trials

CONSORT Statement

Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.
Ann Int Med 2010;152 (11):726-32. PMID: 20335313
BMC Medicine 2010, 8:18. PMID: 20334633
BMJ 2010;340:c332. PMID: 20332509
J Clin Epi 2010; 63(8): 834-40 PMID: 20346629
Lancet 2010; 375(9721):1136 supplementary webappendix
Obstet Gynecol 2010;115(5):1063-70. PMID: 20410783
Open Med 2010;4(1):60-68.
PLoS Med 2010;7(3): e1000251. PMID: 20352064
Trials 2010, 11:32. PMID: 20334632

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, for the CONSORT Group. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial.
BMJ 2010;340:c869. PMID: 20332511
J Clin Epi 2010; 63(8): e1-e37  PMID: 20346624

Note: CONSORT 2010 replaces CONSORT 2001 (PMID: 11323066; PMID: 11304107)


Official CONSORT extensions: The CONSORT group extended the CONSORT 2001 Statement to cover some specific issues (please note that work is underway to modify various CONSORT extensions to reflect the revised CONSORT 2010):

CONSORT Harms:
Reporting harms in randomised controlled trials (RCTs)		 Ioannidis JPA, Evans SJW, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, for the CONSORT Group*. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. Ann Intern Med 2004; 141(10):781-788.
PMID: 15545678

CONSORT Non-inferiority:
Reporting noninferiority and equivalence RCTs		 Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW, for the CONSORT Group. Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement. JAMA: The Journal of the American Medical Association 2006; 295(10):1152-1160.
PMID: 16522836

CONSORT Cluster:
Reporting cluster RCTs		 Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328(7441):702-708.
PMID: 15031246

CONSORT Herbal:
Reporting of herbal interventions RCTs		 Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group*. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann Intern Med 2006; 144(5):364-367.
PMID: 16520478

CONSORT Non-pharmacological treatment interventions

Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008:W60-W67.
PMID: 18283201

Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008 Feb 19;148(4):295-309.
PMID: 18283207


CONSORT Abstracts

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF and the CONSORT Group (2008) CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 5(1): e20. doi:10.1371/journal. pmed.0050020.
PMID: 18215107

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008 Jan 26;371(9609):281-3.
PMID: 18221781


CONSORT Pragmatic Trials

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
PMID: 19001484


STRICTA

Controlled trials of acupuncture

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. PMID: 20543992

This revised guidance replaces STRICTA 2001 (PMID: 12184354 , PMID: 11926601 PMID: 11890439)

Unofficial CONSORT extensions: Other attempts have also been made by groups independent from the CONSORT group to expand CONSORT criteria to other areas of clinical research:

Paediatric RCTs CONSORT -C(hildren)
Saint-Raymond A, Hill S, Martines J, Bahl R, Fontaine O, Bero L. CONSORT 2010. Lancet. 2010; 376(9737):229-30. PMID: 20656114

Behavioural medicine RCTs Davidson KW, Goldstein M, Kaplan RM, Kaufmann PG, Knatterud GL, Orleans CT, Spring B, Trudeau KJ, Whitlock EP. Evidence-based behavioral medicine: what is it and how do we achieve it? Ann Behav Med 2003; 26(3):161-171.
PMID: 14644692

Occupational therapy RCTs Moberg-Mogren E, Nelson D. Evaluating the quality of reporting occupational therapy randomized controlled trials by expanding the CONSORT criteria. The American journal of occupational therapy : official publicationof the American Occupational Therapy Association 2006; 60(2):226-235.
PMID: 16596926

RedHot

Homeopathic treatments 

Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): A supplement to CONSORT. Forschende Komplementarmedizin und Klassische Naturheilkunde 2006; 13(6):368-371.
PMID: 17200612

Adjudication committees in clinical trials
Dechartres A, Boutron I, Roy C, Ravaud P. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal. J Clin Epidemiol 2009 Jul;62(7):695-702.
PMID: 19135860

Data monitoring committees, interim analysis and early termination in clinical trials
Fernandes RM, van der Lee JH, Offringa M. A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials. BMC Pediatr 2009;9:77.
PMID: 20003383
Neuro-oncology trials - phase I and II GNOSIS Chang SM, Reynolds SL, Butowski N, Lamborn KR, Buckner JC, Kaplan RS, Bigner DD. GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials. Neuro oncol 2005; 7(4):425-434.
PMID: 16212807
Neuro-oncology trials - surgery GNOSIS

Chang S, Vogelbaum M, Lang FF, Haines S, Kunwar S, Chiocca EA, et al. GNOSIS: Guidelines for Neuro-Oncology: Standards for Investigational Studies - reporting of surgically based therapeutic clinical trials. Journal of Neuro-Oncology 2007;82(2):211-20.
PMID: 17146595
Phase II trials with historical data
Vickers AJ, Ballen V, Scher HI. Setting the bar in phase II trials: the use of historical data for determining “go/no go” decision for definitive phase III testing. Clin Cancer Res 2007; 13(3):972-976.
PMID: 17277252
Non-randomised evaluations of behavioural and public health interventions TREND Des Jarlais DC, Lyles C, Crepaz N, Trend Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. American Journal of Public Health 2004; 94(3):361-366.
PMID: 14998794
Non-randomised studies
Reeves BC, Gaus W. Guidelines for reporting non-randomised studies. Forsch Komplementarmed Klass Naturheilkd 2004; 11 Suppl 1:46-52.
PMID: 15353903
Infection control intervention studies ORION Stone SP, Cooper BS, Kibbler CC, Cookson BD, Roberts JA, Medley GF, Duckworth G, Lai R, Ebrahim S, Brown EM, Wiffen PJ, Davey PG. The ORION statement: guidelines for transparent reporting of Outbreak Reports and Intervention studies Of Nosocomial infection.
J Antimicrob Chemother 2007; 59(5):833-840. PMID: 17387116
Lancet Infect Dis 2007; 7: 282–288.
PMID: 17376385

Basic research in homeopathy


 REHBaR
 Stock-Schroer B, Albrecht H, Betti L, Endler PC, Linde K, Ludtke R, et al. Reporting experiments in homeopathic basic research (REHBaR)--a detailed guideline for authors. Homeopathy 2009 Oct;98(4):287-98.
PMID: 19945681

Page last edited: 29 July 2010