Guidelines for reporting experimental studies

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Randomised controlled trials (RCTs)
Neuro-oncology trials (Phase I and II and surgery)
Phase II trials with historical data
Non-randomised studies
Comparative effectiveness research
Infection control intervention studies
Basic research in homeopathy

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)
Protocols for clinical trials	SPIRIT 2013 Statement	Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013;158(3):200-7. PMID: 23295957 Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586 PMID: 23303884
	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 PRO: Reporting of patient-reported outcomes in randomized trials	Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814-22. PMID: 23443445
	CONSORT Non-inferiority: Reporting noninferiority and equivalence RCTs	Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594-604. PMID: 23268518 Note: reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement replaces reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement published in 2006 (PMID: 16522836)
	CONSORT Cluster: Reporting cluster RCTs	Campbell MK, Piaggio G, Elbourne DR, Altman DG; for the CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. PMID: 22951546 Note: the CONSORT 2010 statement: extension to cluster trials replaces the CONSORT statement: extension to cluster randomised trials published in 2004 (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; 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:
	Allergen-specific immunotherapy	Bousquet PJ, Brozek J, Bachert C, Bieber T, Bonini S, Burney P, et al. The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper. Allergy 2009; 64(12):1737-45. PMID: 19860788
	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
Behavioural medicine RCTs	WIDER recommendations	WIDER recommendations for reporting of behaviour change interventions. On behalf of the Workgroup for Intervention Development and Evaluation Research. Full-text (in pdf format) available from: WIDER recommendations
	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
Tailored intervention studies		Harrington NG, Noar SM. Reporting standards for studies of tailored interventions. Health Educ Res. 2012;27(2):331-42. PMID: 22156230
Vibration intervention studies		Rauch F, Sievanen H, Boonen S, Cardinale M, Degens H, Felsenberg D, Roth J, Schoenau E, Verschueren S, Rittweger J. Reporting whole-body vibration intervention studies: recommendations of the International Society of Musculoskeletal and Neuronal Interactions. J Musculoskelet Neuronal Interact. 2010;10(3):193-8. PMID: 20811143
	Music-based interventions (expanding CONSORT and TREND)	Robb SL, Carpenter JS, Burns DS. Reporting guidelines for music-based interventions. J Health Psychol. 2010 PMID: 20709884
eHealth interventions		Baker TB, Gustafson DH, Shaw B, Hawkins R, Pingree S, Roberts L, Strecher V. Relevance of CONSORT reporting criteria for research on eHealth interventions. Patient Educ Couns. 2010;81 Suppl:S77-86. PMID: 20843621
	CONSORT-EHEALTH	Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13(4):e126. PMID: 22209829
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
Quality of life assessed in clinical trials		Staquet M, Berzon R, Osoba D, Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. QUAL LIFE RES 1996; 5(5):496-502. PMID: 8973129
Quality of life in cancer clinical trials		Lee CW, Chi KN. The standard of reporting of health-related quality of life in clinical cancer trials. J Clin Epidemiol 2000; 53(5):451-458. PMID: 10812316
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
Complex interventions	CReDECI	Möhler R, Bartoszek G, Köpke S, Meyer G. Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development. Int J Nurs Stud. 2012;49(1):40-6. PMID: 21924424
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
	Music-based interventions (expanding CONSORT and TREND)	Robb SL, Carpenter JS, Burns DS. Reporting guidelines for music-based interventions. J Health Psychol. 2011; 16 (2):342-52. PMID: 20709884
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
Comparative effectiveness research		Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: Defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: The ISPOR good research practices for retrospective database analysis task force report - Part i. Value in Health 2009; 12(8):1044-52. PMID: 19793072
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(4):282–288. PMID: 17376385
Intervention studies of health benefits of foods		Welch RW, Antoine JM, Berta JL, Bub A, de Vries J, Guarner F, Hasselwander O, Hendriks H, Jäkel M, Koletzko BV, Patterson CC, Richelle M, Skarp M, Theis S, Vidry S, Woodside JV; International Life Sciences Institute Europe Functional Foods Task Force. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr. 2011;106 Suppl 2:S3-15. PMID: 22129662
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;98(4):287-98. PMID: 19945681
Mixed research in counselling (quantitative and qualitative)		Leech NL, Onwuegbuzie AJ. Guidelines for conducting and reporting mixed research in the field of counseling and beyond. Journal of Counseling and Development 2010; 88(1):61-9.

Page last edited: 15 March 2013