Evidence map›Paper›PMID 38026054›Full record

ArticleSchizophrenia bulletin open2023

Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.

William P Horan, Colin A Depp, Samantha Hurst, Jared Linthicum, Gabriela Vargas, Hans Klein, Richard S E Keefe, Philip D Harvey

Abstract read
In one paragraph

Article in Schizophrenia bulletin open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Mend the Gap: Online User-Led Adjuvant Treatment for Psychosis: A Systematic Review on Recent Findings.International journal of environmental research and public health · 2025
    Pooled it
  2. Article
  3. Article
  4. Article
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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

8 authors.

William P HoranWCG Clinical Endpoint Solutions, Cary, NC.
Colin A DeppHerbert Wertheim School of Public Health & Human Longevity Science, University of California, San Diego, CA.
Samantha HurstHerbert Wertheim School of Public Health & Human Longevity Science, University of California, San Diego, CA.
Jared LinthicumWCG Clinical Endpoint Solutions, Cary, NC.
Gabriela VargasDepartment of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Research Service Bruce W. Carter VA Medical Center, Miami, FL.
Hans KleinWCG Clinical Endpoint Solutions, Cary, NC.
Richard S E KeefeDepartment of Psychiatry, Duke University, Durham, NC.
Philip D HarveyDepartment of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Research Service Bruce W. Carter VA Medical Center, Miami, FL.

Funding

Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in SchizophreniaU01FD006872 · FDA · VERASCI, LLC · PI HORAN, WILLIAM P. · 2019 to 2019
$250k
FDA HHS U01 FD006872
6 · The paper itself

Abstract

The US Food and Drug Agency (FDA) requires clinical trials targeting cognitive impairment associated with schizophrenia (CIAS) to demonstrate the functional relevance of cognitive improvements by employing a functional co-primary measure. Although quantitative evidence supports the suitability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for this purpose, FDA guidelines for qualification of clinical outcome assessments require evidence of content validity, defined as qualitative evidence that key stakeholders view the measure as relevant and important. To collect this important qualitative data, semi-structured interviews were conducted with outpatients with schizophrenia (

Indexed as

caregiverclinical outcome assessmentco-primary measurefunctional independence

Identifiers

PMID38026054
PMCPMC10664622

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.