- Resource Centre
- Library for health research reporting
- Reporting Guidelines
- Experimental studies
- Observational studies
- Diagnostic accuracy studies
- Biospecimen reporting
- Reliability and agreement studies
- Systematic reviews and meta-analysis
- Qualitative research
- Mixed methods studies
- Economic evaluations
- Quality improvement studies
- Other reporting guidelines
- Reporting data
- Statistical methods and analyses
- Sections of research reports
- Specific conditions or procedures
- Reporting guidelines under development
- Reporting guidelines in other research fields
- Guidance on scientific writing
- Guidance developed by editorial groups
- Research funders' guidance on reporting requirements
- Industry sponsored research - additional guidance
- Research ethics, publication ethics and good practice guidelines
- Development and maintenance of reporting guidelines
- Editorials introducing RGs
- Examples of guidelines for peer reviewers
- Case studies: RG implementation
- Examples of good research reporting
- EQUATOR 'pick'
- Reporting Guidelines
- Authors of research reports
- Editors and peer reviewers
- Reporting guidelines developers
- Promote responsible reporting
- Monitoring use of our resources
Guidelines for reporting experimental studies
- 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||
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.
| 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.
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
|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):|
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.
|| 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.
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.
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)
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)
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.
|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.
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.
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.
|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.
|Behavioural medicine RCTs||
| 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.
|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.
|Tailored intervention studies||
|| Harrington NG, Noar SM. Reporting standards for studies of tailored interventions. Health Educ Res. 2012;27(2):331-42.
|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|
|| 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
|| 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.
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.
|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.
|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.
|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.
| Complex interventions
|| 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.
|| 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.
| 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.
| 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.
| 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