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Guidance for reporting experimental studies
Shortcuts:
- Randomised controlled trials (RCTs)
- Neuro-oncology trials (Phase I and II and surgery)
- Phase II trials with historical data
- Non-randomised studies
- Infection control intervention studies
- Basic research in homeopathy
| Reporting guidance provided for: | Name of guideline website (where available) | References including PMID |
|---|---|---|
| Randomised controlled trials |
|
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. |
| 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. 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.
|
|
| 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. 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. |
|
| 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. |
|
| Other attempts have also been made by groups independent from the CONSORT group to expand CONSORT criteria to other areas of clinical research: | ||
|
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 |
|
|
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. |
| 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 |
|
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
