Evidence map›Paper›PMID 27436797›Full record

ArticleStatistics in medicine2016

Adaptive pre-specification in randomized trials with and without pair-matching.

Laura B Balzer, Mark J van der Laan, Maya L Petersen, SEARCH Collaboration

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Statistics in medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01864603 (Sustainable East Africa Research in Community Health), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01864603 nacompletednot on this map

Sustainable East Africa Research in Community Health

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2021Enrolled150,395ConditionsHIV, Tuberculosis, Hypertension, DiabetesArmsUniversal ART in a streamlined care model, Annual Community Health Campaigns, Targeted PrEP and Targeted testing interventions, Baseline community-based HIV and multi-disease testing
3 · Its place in the literature

Who cites it

33 citing papers in PubMed.

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  7. SEARCH Human Immunodeficiency Virus (HIV) Streamlined Treatment Intervention Reduces Mortality at a Population Level in Men With Low CD4 Counts.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Laura B BalzerDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, 02115, MA, U.S.A.. lbbalzer@hsph.harvard.edu.ORCID 0000-0002-3730-410X
Mark J van der LaanDivision of Biostatistics, University of California, Berkeley, 94110-7358, CA, U.S.A.
Maya L PetersenDivision of Biostatistics, University of California, Berkeley, 94110-7358, CA, U.S.A.
SEARCH CollaborationDivision of HIV, Infectious Diseases and Global Medicine, University of California, San Francisco, 94143-0874, CA, U.S.A.

Funding

Reducing Failure-to-Initiate ART: Streamlined ART Start Strategy (START)U01AI099959 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2012 to 2016
$39.7M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
UCSF HIV Clinical Trials UnitUM1AI069502 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2012 to 2013
$10.3M
Targeted Learning using adaptive designs for HIV Epidemic control in East AfricaR01AI074345 · NIAID · UNIVERSITY OF CALIFORNIA BERKELEY · PI PETERSEN, MAYA LIV, VANDERLAAN, MARK J · 2007 to 2023
$6.6M
NIAID NIH HHS R01 AI074345NIAID NIH HHS U01 AI099959NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069502PEPFAR
6 · The paper itself

Abstract

In randomized trials, adjustment for measured covariates during the analysis can reduce variance and increase power. To avoid misleading inference, the analysis plan must be pre-specified. However, it is often unclear a priori which baseline covariates (if any) should be adjusted for in the analysis. Consider, for example, the Sustainable East Africa Research in Community Health (SEARCH) trial for HIV prevention and treatment. There are 16 matched pairs of communities and many potential adjustment variables, including region, HIV prevalence, male circumcision coverage, and measures of community-level viral load. In this paper, we propose a rigorous procedure to data-adaptively select the adjustment set, which maximizes the efficiency of the analysis. Specifically, we use cross-validation to select from a pre-specified library the candidate targeted maximum likelihood estimator (TMLE) that minimizes the estimated variance. For further gains in precision, we also propose a collaborative procedure for estimating the known exposure mechanism. Our small sample simulations demonstrate the promise of the methodology to maximize study power, while maintaining nominal confidence interval coverage. We show how our procedure can be tailored to the scientific question (intervention effect for the study sample vs. for the target population) and study design (pair-matched or not). Copyright © 2016 John Wiley & Sons, Ltd.

Indexed as

Randomized Controlled Trials as TopicResearch DesignHIV InfectionsHumansMaleProbabilitycausal inferencecovariate selectiondata-adaptivepair-matchedrandomized trialstargeted maximum likelihood estimation (TMLE)

Identifiers

PMID27436797
PMCPMC5084457

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.