Evidence map›Paper›PMID 32841462›Full record

Trial reportInternational journal of methods in psychiatric research2021

Evaluating functional disability in clinical trials of lisdexamfetamine dimesylate in binge eating disorder using the Sheehan Disability Scale.

Karen S Yee, Robin Pokrzywinski, Asha Hareendran, Shannon Shaffer, David V Sheehan

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of methods in psychiatric research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 34% of its field
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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

5 authors at 4 institutions in 1 country.

Karen S YeeShire, a Member of the Takeda Group of Companies, Cambridge, Massachusetts, USA.ORCID 0000-0002-6026-1435
Robin PokrzywinskiPatient-Centered Research, Evidera, Bethesda, Maryland, USA.
Asha HareendranPatient-Centered Research, Evidera, London, UK.
Shannon ShafferPatient-Centered Research, Evidera, Bethesda, Maryland, USA.
David V SheehanUniversity of South Florida College of Medicine, Tampa, Florida, USA.
Institute for Patient- and Family-Centered Care · USIthaka Harbors · USTakeda (United States) · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study examined Sheehan Disability Scale (SDS) performance in binge eating disorder (BED) and explored relationships between SDS and BED outcomes using data from three placebo-controlled lisdexamfetamine (LDX) studies (two short-term, dose-optimized studies and one double-blind, randomized-withdrawal study) in adults with Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR)-defined BED.

methodsAnalyses evaluated the psychometric properties of the SDS.

resultsConfirmatory factor analysis supported a unidimensional total score in the short-term studies, with internal consistency (Cronbach's α) being 0.878. Total score exhibited good construct validity, with moderate and statistically significant correlations observed with Yale-Brown Obsessive Compulsive Scale modified for binge eating, Binge Eating Scale (BES), and EuroQol Group 5-Dimension 5-Level health status index scores. Known-groups validity analysis for the short-term studies demonstrated a significantly lower total score at end of study in participants considered "not ill" versus "ill" based on Clinical Global Impressions-Severity scores. SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score. In the randomized-withdrawal study, SDS scores increased relative to baseline to a greater extent in participants randomized to placebo than LDX.

conclusionsThese analyses support the reliability, validity, and responsiveness to change of the SDS in individuals with BED.

Indexed as

Binge-Eating DisorderLisdexamfetamine DimesylateAdultDouble-Blind MethodHumansPsychometricsReproducibility of ResultsLisdexamfetamine Dimesylatebinge eating disorderpsychometric propertiesreliabilityresponsivenessvalidity

Identifiers

PMID32841462
PMCPMC7992284
OpenAlexW3080676224

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.