Evidence map›Paper›PMID 36747254›Full record

ArticleTrials2023

Can multisite clinical trial results change clinical practice? Use of long-acting injectable risperidone nationally in the Veterans Health Administration.

Robert Rosenheck, Sonia T Anand, Stephen G Kurtz, Cynthia Hau, Diane Smedberg, James F Pontzer, Ryan E Ferguson, Cynthia R Davis

Open access · goldAbstract read
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 98% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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 at 4 institutions in 1 country.

Robert RosenheckVA New England Mental Illness, Research, Education and Clinical Center, 151D, 950 Campbell Ave., West Haven, CT, 06516, USA. robert.rosenheck@yale.edu.ORCID http://orcid.org/0000-0003-4314-4592
Sonia T AnandVA Cooperative Studies Program Coordinating Center, Boston, MA, USA.
Stephen G KurtzVA Cooperative Studies Program Coordinating Center, Boston, MA, USA.
Cynthia HauVA Cooperative Studies Program Coordinating Center, Boston, MA, USA.
Diane SmedbergVA Cooperative Studies Program Coordinating Center, Boston, MA, USA.
James F PontzerVA Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA.
Ryan E FergusonVA Cooperative Studies Program Coordinating Center, Boston, MA, USA.
Cynthia R DavisHarvard Medical School, Boston, MA, USA.
Program Support Center · USHarvard University · USVA Office of Research and Development · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundMultisite practical clinical trials evaluate treatments in real-world practice. A multisite randomized Veterans Health Administration (VHA) cooperative study (CSP#555) published in 2011 compared the first long-acting injectable (LAI) second-generation antipsychotic (SGA), Risperidone Consta®, in veterans with a diagnosis of schizophrenia or schizoaffective disorder, to oral antipsychotics, with unexpected null results for effectiveness and cost-effectiveness. Whether null results of this type could change VHA practice has not been studied.

methodsA longitudinal observational analysis was used to evaluate the impact of the trial findings on VHA clinical practices. National administrative data compared new starts on LAI risperidone during the 4 years before the publication of CSP#555 in 2011 to new starts on LAI risperidone during the 4 years after.

resultsAmong 119,565 Veterans with the indicated diagnoses treated with antipsychotics from 2007 to 2015, the number and proportion of new starts on LAI risperidone declined significantly following the study publication, as did the total number of annual users and drug expenditures. However, data from 2007 to 2010 showed the decline in new starts actually preceded the publication of CSP#555. This change was likely explained by the increase in new starts, total use, and expenditures on a newer medicine, LAI paliperidone, a 4-week LAI treatment, in the 2 years prior to the publication of CSP#555.

conclusionsThe declining use of LAI risperidone likely primarily reflects the substitution of a longer-acting LAI SGA, paliperidone, that came to market 2 years before the study publication, a substitution that may have been reinforced by null CSP#555 study results for LAI risperidone.

Indexed as

Antipsychotic AgentsRisperidoneDelayed-Action PreparationsHumansInjectionsPaliperidone PalmitateVeterans HealthAntipsychotic AgentsDelayed-Action PreparationsPaliperidone PalmitateRisperidoneClinical trial impactDissemination of researchLong-acting antipsychotic medicationSchizophrenia

Identifiers

PMID36747254
PMCPMC9900548
OpenAlexW4319298228

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.