Evidence map›Paper›PMID 25828873›Full record

Observational studyPsychiatric services (Washington, D.C.)2015

Predicting Participation in Psychiatric Randomized Controlled Trials: Insights From the STEP-BD.

Alisa B Busch, Yulei He, Katya Zelevinsky, Alistair J O'Malley

Abstract readComparative StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Psychiatric services (Washington, D.C.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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.

Alisa B BuschDr. Busch and Ms. Zelevinsky are with the Department of Health Care Policy, Harvard Medical School, Boston (e-mail: abusch@hcp.med.harvard.edu ), where Dr. He was affiliated when this work was done. Dr. Busch is also with McLean Hospital, Belmont, Massachusetts. Dr. He is now with the Office of Research and Methodology, National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Maryland. Dr. O'Malley is with the Dartmouth Institute of Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire.
Yulei HeDr. Busch and Ms. Zelevinsky are with the Department of Health Care Policy, Harvard Medical School, Boston (e-mail: abusch@hcp.med.harvard.edu ), where Dr. He was affiliated when this work was done. Dr. Busch is also with McLean Hospital, Belmont, Massachusetts. Dr. He is now with the Office of Research and Methodology, National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Maryland. Dr. O'Malley is with the Dartmouth Institute of Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire.
Katya ZelevinskyDr. Busch and Ms. Zelevinsky are with the Department of Health Care Policy, Harvard Medical School, Boston (e-mail: abusch@hcp.med.harvard.edu ), where Dr. He was affiliated when this work was done. Dr. Busch is also with McLean Hospital, Belmont, Massachusetts. Dr. He is now with the Office of Research and Methodology, National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Maryland. Dr. O'Malley is with the Dartmouth Institute of Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire.
Alistair J O'MalleyDr. Busch and Ms. Zelevinsky are with the Department of Health Care Policy, Harvard Medical School, Boston (e-mail: abusch@hcp.med.harvard.edu ), where Dr. He was affiliated when this work was done. Dr. Busch is also with McLean Hospital, Belmont, Massachusetts. Dr. He is now with the Office of Research and Methodology, National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Maryland. Dr. O'Malley is with the Dartmouth Institute of Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire.

Funding

Accounting for confounding bias and heterogeneity in comparative effectivenessRC4MH092717 · NIMH · HARVARD MEDICAL SCHOOL · PI O'MALLEY, ALISTAIR JAMES · 2010 to 2010
$1.5M
Quality of Care for Bipolar DisorderK01MH071714 · NIMH · HARVARD MEDICAL SCHOOL · PI BUSCH, ALISA B · 2006 to 2010
$886k
NIMH NIH HHS K01 MH071714NIMH NIH HHS K01MH071714NIMH NIH HHS RC4 MH092717
6 · The paper itself

Abstract

objectiveDifferences between patients who do and do not participate in randomized controlled trials (RCTs) could diminish the generalizability of results. This study examined whether RCT participants differ from non-RCT participants who are recruited from the same patient and provider population.

methodsThe Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) was an observational study in which participants also could enroll in an RCT during exacerbations of acute depression. The odds that a patient was enrolled in the STEP-BD acute depression RCTs (pharmacotherapy or psychotherapy) were estimated by fitting logistic regression models to STEP-BD participants with acute bipolar depression (total N=2,222; RCT, N=413; observational arm, N=1,809). Predictor variables included demographic characteristics, clinical information (including severity scales and comorbidities), and study site. The extent to which site determined RCT participation was estimated by using the area under the receiver operating characteristic curve (AUC).

resultsRCT participation was associated with having no insurance (odds ratio [OR]=1.58, 95% confidence interval [CI]=1.16-2.15), a Clinical Global Impression score indicating greater severity (severe versus mild: OR=1.52, CI=1.08-2.15), and site (predicted probability range 8%-31%). Site was the most significant predictor of RCT enrollment (model excluding site, AUC=.61, CI=.58-.64; full model, AUC=.70, CI=.67-.73).

conclusionsSTEP-BD RCT participants differed from those in the observational arm in few clinical or demographic characteristics. Site was the strongest predictor of RCT participation. Future study is needed to understand site characteristics associated with RCT participation and whether these characteristics are associated with patient outcomes and to test these findings in usual-care settings.

Indexed as

Patient SelectionRandomized Controlled Trials as TopicAdultBipolar DisorderFemaleHumansMaleMiddle AgedMulticenter Studies as TopicOutcome Assessment, Health Care

Identifiers

PMID25828873
PMCPMC4888778

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Registered trials

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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.