The intention-to-treat principle: How to assess the true effect of choosing a medical treatment

JAMA

Volumn 312, Issue 1, 2014, Pages 85-86

  Detry, Michelle A ^a   Lewis, Roger J ^a,b,c,d  

^a BERRY CONSULTANTS   (United States)

^b HARBOR UCLA MEDICAL CENTER   (United States)

^c LOS ANGELES BIOMEDICAL RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ERYTHROPOIETIN; PLACEBO;

ADVERSE DRUG REACTION; ANEMIA; BLOOD TRANSFUSION; CLINICAL EFFECTIVENESS; EXPERIMENTAL THERAPY; FACTORIAL DESIGN; GLASGOW COMA SCALE; HUMAN; INTENTION TO TREAT ANALYSIS; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; TRAUMATIC BRAIN INJURY;

ANEMIA; BRAIN INJURIES; ERYTHROCYTE TRANSFUSION; ERYTHROPOIETIN; FEMALE; HEMOGLOBINS; HUMANS; MALE;

EID: 84903555283     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.7523     Document Type: Review

References (8)

1. Cook T, DeMets DL. Introduction to Statistical Methods for Clinical Trials. Boca Raton, FL: Chapman & Hall/CRC; Taylor & Francis Group; 2008:chp 11.
2. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726-732.
3. Food and Drug Administration. Guidance for industry e9 statistical principles for clinical trials. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm073137.pdf. September 1998. Accessed May 11, 2014.
4. Robertson CS, Hannay HJ, Yamal J-M, et al; and the Epo Severe TBI Trial Investigators. Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial. JAMA. doi:10.1001/jama.2014.6490.
5. Montedori A, Bonacini MI, Casazza G, et al. Modified versus standard intention-to-treat reporting: are there differences inmethodological quality, sponsorship, and findings in randomized trials? a cross-sectional study. Trials. 2011;12:58.
6. 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):2594-2604.
7. Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA. 2006;295(10):1147-1151. (Pubitemid 43352344)
8. Mulla SM, Scott IA, Jackevicius CA, et al. How to use a noninferiority trial: Users' Guides to the Medical Literature. JAMA. 2012;308:2605-2611.