Best (but oft-forgotten) practices: Intention-to-treat, treatment adherence, and missing participant outcome data in the nutrition literature1

American Journal of Clinical Nutrition

Volumn 104, Issue 5, 2016, Pages 1197-1201

  Johnston, Bradley C ^a,b,c   Guyatt, Gordon H ^d,e  

^a Prevention Lab   (United States)

^b HOSPITAL FOR SICK CHILDREN   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

^d Department of Clinical Epidemiology and Biostatistics ^*  (Canada)

^e MCMASTER UNIVERSITY   (Canada)

Author keywords

Adherence; Clinical trials; Intention to treat; Missing outcome data; Patient dropouts; Per protocol; Randomization

Indexed keywords

CLINICAL STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FOLLOW UP; HUMAN; NUTRITION; PATIENT DROPOUT; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; INTENTION TO TREAT ANALYSIS; METHODOLOGY; NUTRITIONAL STATUS; PATIENT COMPLIANCE; PROCEDURES; ADULT; CASE REPORT; CLINICAL ARTICLE; FEMALE; MALE; NOTE; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC);

FOLLOW-UP STUDIES; HUMANS; INTENTION TO TREAT ANALYSIS; LOST TO FOLLOW-UP; NUTRITIONAL STATUS; PATIENT COMPLIANCE; PATIENT DROPOUTS; RESEARCH DESIGN;

EID: 84994223704     PISSN: 00029165     EISSN: 19383207     Source Type: Journal    
DOI: 10.3945/ajcn.115.123315     Document Type: Review

References (17)

1. Guyatt G, Meade MO, Cook DJ, Rennie D. Users' guides to the medical literature: a manual for evidence-based clinical practice, 3rd ed. New York: McGraw-Hill; 2014.
2. Gadbury GL, Coffey CS, Allison DB. Modern statistical methods for handling missing repeated measurements in obesity trial data: beyond LOCF. Obes Rev 2003;4:175-84.
3. Elobeid MA, Padilla MA, McVie T, Thomas O, Brock DW, Musser B, Lu K, Coffey CS, Desmond RA, St-Onge MP, et al. Missing data in randomized clinical trials for weight loss: scope of the problem, state of the field, and performance of statistical methods. PLoS One 2009; 4:e6624.
4. Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ 2001; 165:1339-41.
5. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002;325:652-4.
6. Heshka S, Anderson JW, Atkinson RL, Greenway FL, Hill JO, Phinney SD, Kolotkin RL, Miller-Kovach K, Pi-Sunyer FX. Weight loss with self-help compared with a structured commercial program: a randomized trial. JAMA 2003;289:1792-8.
7. Dunn G, Maracy M, Tomenson B. Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods. Stat Methods Med Res 2005; 14:369-95.
8. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999;319:670-4.
9. Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J. Intention to treat analysis is related to methodological quality. BMJ 2000;320:1007-8.
10. Kruse RL, Alper BS, Reust C, Tevermer JJ, Shannon S, Williams RH. Intention-to-treat analysis: who is in? Who is out? J Fam Pract 2002; 51:969-71.
11. Gravel J, Opatrny L, Shapiro S. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? Clin Trials 2007;4:350-6.
12. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340:c332.
13. Ioannidis JP, Bassett R, Hughes MD, Volberding PA, Sacks HS, Lau J. Predictors and impact of patients lost to follow-up in a long-term randomized trial of immediate versus deferred antiretroviral treatment. J Acquir Immune Defic Syndr Hum Retrovirol 1997;16:22-30.
14. Alshurafa M, Briel M, Akl EA, Haines T, Moayyedi P, Gentles SJ, Rios L, Tran C, Bhatnagar N, Lamontagne F, et al. Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PLoS One 2012;7:e49163.
15. Akl EA, Johnston BC, Alonso-Coello P, Neumann I, Ebrahim S, Briel M, Cook DJ, Guyatt GH. Addressing dichotomous data for participants excluded from trial analysis: a guide for systematic reviewers. PLoS One 2013;8:e57132.
16. Akl EA, Briel M, You JJ, Sun X, Johnston BC, Busse JW, Mulla S, Lamontagne F, Bassler D, Vera C, et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ 2012;344:e2809.
17. Erdeve O, Tiras U, Dallar Y. The probiotic effect of Saccharomyces boulardii in a pediatric age group. J Trop Pediatr 2004;50:234-6.