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


Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.
Lancet 2001;357:1191-1194. 
PMID: 11323066
JAMA 2001;285:1987-1991.
PMID: 11308435
Ann Intern Med 2001; 134(8):657-662.
PMID: 11304106

Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration.
Ann Intern Med 2001; 134(8):663-694.
PMID: 11304107


The CONSORT group extended the Statement to cover some specific issues:

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


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

STRICTA

Controlled trials of acupuncture

MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trials of Acupuncture.
Complement Ther Med 2001;9(4):246-9. PMID: 12184354
Acupunct Med 2002; 20(1):22-25. PMID: 11926601
J Altern Complement Med 2002; 8(1):85-9. PMID: 11890439

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
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

New

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: 13 January 2010