dc.contributor.author |
Elobeid, Mai A |
|
dc.contributor.author |
Padilla, Miguel A |
|
dc.contributor.author |
McVie, Theresa |
|
dc.contributor.author |
Thomas, Olivia |
|
dc.contributor.author |
Brock, David W |
|
dc.contributor.author |
Musser, Bret |
|
dc.contributor.author |
Lu, Kaifeng |
|
dc.contributor.author |
Coffey, Christopher S |
|
dc.contributor.author |
Desmond, Renee A |
|
dc.contributor.author |
St-Onge, Marie-Pierre |
|
dc.contributor.author |
Gadde, Kishore M |
|
dc.contributor.author |
Heymsfield, Steven B |
|
dc.contributor.author |
Allison, David B |
|
dc.coverage.spatial |
United States |
|
dc.date.accessioned |
2011-06-21T17:31:26Z |
|
dc.date.issued |
2009-08-13 |
|
dc.identifier |
https://www.ncbi.nlm.nih.gov/pubmed/19675667 |
|
dc.identifier.uri |
https://hdl.handle.net/10161/4515 |
|
dc.description.abstract |
BACKGROUND: Dropouts and missing data are nearly-ubiquitous in obesity randomized
controlled trails, threatening validity and generalizability of conclusions. Herein,
we meta-analytically evaluate the extent of missing data, the frequency with which
various analytic methods are employed to accommodate dropouts, and the performance
of multiple statistical methods. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed
and Cochrane databases (2000-2006) for articles published in English and manually
searched bibliographic references. Articles of pharmaceutical randomized controlled
trials with weight loss or weight gain prevention as major endpoints were included.
Two authors independently reviewed each publication for inclusion. 121 articles met
the inclusion criteria. Two authors independently extracted treatment, sample size,
drop-out rates, study duration, and statistical method used to handle missing data
from all articles and resolved disagreements by consensus. In the meta-analysis, drop-out
rates were substantial with the survival (non-dropout) rates being approximated by
an exponential decay curve (e(-lambdat)) where lambda was estimated to be .0088 (95%
bootstrap confidence interval: .0076 to .0100) and t represents time in weeks. The
estimated drop-out rate at 1 year was 37%. Most studies used last observation carried
forward as the primary analytic method to handle missing data. We also obtained 12
raw obesity randomized controlled trial datasets for empirical analyses. Analyses
of raw randomized controlled trial data suggested that both mixed models and multiple
imputation performed well, but that multiple imputation may be more robust when missing
data are extensive. CONCLUSION/SIGNIFICANCE: Our analysis offers an equation for predictions
of dropout rates useful for future study planning. Our raw data analyses suggests
that multiple imputation is better than other methods for handling missing data in
obesity randomized controlled trials, followed closely by mixed models. We suggest
these methods supplant last observation carried forward as the primary method of analysis.
|
|
dc.language |
eng |
|
dc.language.iso |
en_US |
|
dc.publisher |
Public Library of Science (PLoS) |
|
dc.relation.ispartof |
PLoS One |
|
dc.relation.isversionof |
10.1371/journal.pone.0006624 |
|
dc.subject |
Data Interpretation, Statistical |
|
dc.subject |
Humans |
|
dc.subject |
Obesity |
|
dc.subject |
Randomized Controlled Trials as Topic |
|
dc.subject |
Weight Loss |
|
dc.title |
Missing data in randomized clinical trials for weight loss: scope of the problem,
state of the field, and performance of statistical methods.
|
|
dc.title.alternative |
|
|
dc.type |
Journal article |
|
duke.contributor.id |
Gadde, Kishore M|0116136 |
|
dc.description.version |
Version of Record |
|
duke.date.pubdate |
2009-8-13 |
|
duke.description.issue |
8 |
|
duke.description.volume |
4 |
|
dc.relation.journal |
Plos One |
|
pubs.author-url |
https://www.ncbi.nlm.nih.gov/pubmed/19675667 |
|
pubs.begin-page |
e6624 |
|
pubs.issue |
8 |
|
pubs.organisational-group |
Clinical Science Departments |
|
pubs.organisational-group |
Duke |
|
pubs.organisational-group |
Medicine |
|
pubs.organisational-group |
School of Medicine |
|
pubs.publication-status |
Published online |
|
pubs.volume |
4 |
|
dc.identifier.eissn |
1932-6203 |
|