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Trial exclusion criteria and their impact on the estimation of antipsychotic drugs effect: A case study using the SOHO database

dc.rights.licenseopenen_US
dc.contributor.authorNORDON, C.
dc.contributor.authorBOVAGNET, T.
dc.contributor.authorBELGER, M.
dc.contributor.authorJIMENEZ, J.
dc.contributor.authorOLIVARES, R.
dc.contributor.authorCHEVROU-SEVERAC, H.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorVERDOUX, Helene
IDREF: 115951903
dc.contributor.authorHARO, J. M.
dc.contributor.authorABENHAIM, L.
dc.contributor.authorKARCHER, H.
dc.date.accessioned2020-12-14T07:54:10Z
dc.date.available2020-12-14T07:54:10Z
dc.date.issued2018-03
dc.identifier.issn1573-2509 (Electronic) 0920-9964 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/21416
dc.description.abstractEnOBJECTIVES: To explore the impact upon estimation of drug effect as a result of applying exclusion criteria in randomized-controlled trials (RCT) measuring the efficacy of antipsychotics (AP) in schizophrenia. METHODS: Three characteristics which may act as effect-modifiers of AP, while also common exclusion criteria in RCTs, were identified through literature review: schizophrenia duration, substance use disorder and poor adherence. The SOHO cohort was used to estimate the effect of initiating antipsychotic drugs "A", "B" or "C" (pooled) upon symptom evolution at 3months from baseline (CGI-S scale). "Estimated effectiveness" and "estimated efficacy" were drawn from the "SOHO" and "RCT-like" (patients with none of the above-listed exclusion criteria) samples, respectively. Effect-modification and impact of each exclusion criterion on AP effect estimates were explored using non-adjusted statistics. RESULTS: The "SOHO sample" included 8250 patients initiating drug A, B or C at baseline, whose AP "estimated effectiveness" was DeltaCGI-S=-0.78 (95% CI=-0.80, -0.76). The "RCT-like" sub-sample included 5348 (65%) patients whose AP "estimated efficacy" was DeltaCGI-S=-0.73 (95% CI=-0.75, -0.70). Patients with short illness duration (</=3years since first AP; n=2436) experienced significant symptom improvement (DeltaCGI-S=-0.89; 95%CI=-0.93, -0.85) compared to patients with duration >3years (mean DeltaCGI-S=-0.73; 95%CI=-0.76, -0.71). Excluding patients with short illness duration led to a change in AP effect estimates but this was not the case for substance use disorder or poor adherence. CONCLUSION: Using certain exclusion criteria in RCTs may impact the drug's effect estimate, particularly when exclusion criteria are AP effect-modifiers representing frequent characteristics among patients with schizophrenia.
dc.language.isoENen_US
dc.subject.enPharmacoEpi-Drugs
dc.title.enTrial exclusion criteria and their impact on the estimation of antipsychotic drugs effect: A case study using the SOHO database
dc.title.alternativeSchizophr Resen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.schres.2017.07.031en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed28712965en_US
bordeaux.journalSchizophrenia Researchen_US
bordeaux.page146-153en_US
bordeaux.volume193en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03194205
hal.version1
hal.date.transferred2021-04-09T11:42:44Z
hal.exporttrue
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=Schizophrenia%20Research&amp;rft.date=2018-03&amp;rft.volume=193&amp;rft.spage=146-153&amp;rft.epage=146-153&amp;rft.eissn=1573-2509%20(Electronic)%200920-9964%20(Linking)&amp;rft.issn=1573-2509%20(Electronic)%200920-9964%20(Linking)&amp;rft.au=NORDON,%20C.&amp;BOVAGNET,%20T.&amp;BELGER,%20M.&amp;JIMENEZ,%20J.&amp;OLIVARES,%20R.&amp;rft.genre=article


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