Document Detail

Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature.
MedLine Citation:
PMID:  23166608     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Authors of randomized trial reports seem to hold a variety of views regarding the relationship between missing outcome data (MOD) and intention to treat (ITT). The objectives of this study were to systematically investigate how authors of methodology articles define ITT in the presence of MOD, how they recommend handling MOD under ITT, and to make a proposal for potential improvement in the definition and use of ITT in relation to MOD.
METHODS AND FINDINGS: We systematically searched MEDLINE in February 2009 for methodological articles written in English that devoted at least one paragraph to ITT and two other paragraphs to either ITT or MOD. We excluded original trial reports, observational studies, and clinical systematic reviews. Working in teams of two, we independently extracted relevant information from each eligible article. Of 1007 titles and abstracts reviewed, 66 articles met eligibility criteria. Five (8%) did not provide a definition of ITT; 25 (38%) mentioned MOD but did not discuss its relationship to ITT; and 36 (55%) discussed the relationship of MOD with ITT. These 36 articles described one or more of three statements: complete follow-up is required for ITT (58%); ITT and MOD are separate issues (17%); and ITT requires a specific strategy for handling MOD (78%); 17 (47%) endorsed more than one relationship. The most frequently mentioned strategies for handling MOD within ITT were: using the last outcome carried forward (50%); sensitivity analysis (50%); and use of available data to impute missing data (46%).
CONCLUSION: We found that there is no consensus on the definition of ITT in relation to MOD. For conceptual clarity, we suggest that both reports of randomized trials and systematic reviews separately consider and describe how they deal with participants with complete data and those with MOD.
Mohamad Alshurafa; Matthias Briel; Elie A Akl; Ted Haines; Paul Moayyedi; Stephen J Gentles; Lorena Rios; Chau Tran; Neera Bhatnagar; Francois Lamontagne; Stephen D Walter; Gordon H Guyatt
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2012-11-15
Journal Detail:
Title:  PloS one     Volume:  7     ISSN:  1932-6203     ISO Abbreviation:  PLoS ONE     Publication Date:  2012  
Date Detail:
Created Date:  2012-11-20     Completed Date:  2013-05-06     Revised Date:  2013-07-11    
Medline Journal Info:
Nlm Unique ID:  101285081     Medline TA:  PLoS One     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e49163     Citation Subset:  IM    
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
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MeSH Terms
Intention to Treat Analysis / methods*,  standards
Randomized Controlled Trials as Topic / methods*
Research Design / standards*
Selection Bias*
Terminology as Topic*
Grant Support
//Canadian Institutes of Health Research

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