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Journal of Market Access & Health Policy (JMAHP) is published by MDPI from Volume 12 Issue 1 (2024). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Taylor & Francis.
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Article

A Tolerability Burden Index in Schizophrenia: Incorporating Patient Perspective in Clinical Trial Adverse Event Reporting

by
Clément François
1,*,
Alice Guiraud-Diawara
2,
Christophe Lançon
3,
Pierre Michel Llorca
4,
Ann Hartry
1,
Lene Hammer-Helmich
5,
Djamel A. Zighed
6,
Adrian Tanasescu
7 and
Mondher Toumi
8
1
Health Economics Outcome Research, Lundbeck LLC, 6 Parkway North, Deerfield, IL, USA
2
Health Economics Outcome Research, Lundbeck SAS, Issy-les-Moulineaux, France
3
Laboratoire de Santé Publique Évaluation des Systèmes de Soins et Santé Perçue, Université de la Méditerranée–EA 3279–Faculté de Médecine, Marseille 5, France
4
Centre Hospitalier Universitaire Clermont-Ferrand, EA 7280 Université Clermont-Auvergne, Clermont Ferrand, France
5
Health Economics Outcome Research, Lundbeck A/S, Valby, Denmark
6
ERIC Lab, Université de Lyon, Bron, France
7
Rithme Consulting, Villeurbanne, France
8
Department of Public Health, Aix Marseille University, Marseille 5, France
*
Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2017, 5(1), 1372026; https://doi.org/10.1080/20016689.2017.1372026
Submission received: 27 March 2017 / Revised: 1 January 2017 / Accepted: 21 August 2017 / Published: 13 September 2017

Abstract

Background: Adverse event (AE) reporting in clinical trials does not fully capture the patient-level perspective and comparing tolerability across treatments or among studies is difficult. Objective: This study was designed to develop a treatment tolerability index algorithm that combines AE reporting with physician- and patient-level AE information into a global burden score to allow comparison of the overall tolerability of antipsychotic medications used in treating schizophrenia. Study design: Data from a 4-arm, placebo-controlled clinical trial were used in the proposed tolerability index algorithm. For each patient, AEs were adjusted by frequency, severity, duration, and patient-experienced importance, and average tolerability-related burden scores were calculated. Setting: Algorithm development analyses. Patients: This study analyzed data from a previously completed clinical trial that evaluated a potential antipsychotic medication; no patients were involved in the current study. Intervention: No interventions were administered in this study; the analyses described used data derived from a previously completed clinical trial in which patients received bifeprunox, risperidone, or placebo. Main outcome measure: Burden scores and tolerability index scores were compared for patients who did or did not discontinue treatment because of AEs. Results: The number of AEs varied widely among patients. Burden scores were significantly worse for patients who discontinued treatment because of AEs. Mean tolerability index scores, adjusted based on AE frequency, severity-adjusted duration, and patient-experienced impact, were poorer for active medications than placebo, and increased with dose. Conclusion: The treatment tolerability index will allow comparison of AE burden and tolerability between treatments using existing clinical trial information. This suggests that scoring is possible, is clinically relevant, and allows standardized comparison of antipsychotic tolerability.
Keywords: adverse event; antipsychotic; schizophrenia; standardization; tolerability index adverse event; antipsychotic; schizophrenia; standardization; tolerability index

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MDPI and ACS Style

François, C.; Guiraud-Diawara, A.; Lançon, C.; Llorca, P.M.; Hartry, A.; Hammer-Helmich, L.; Zighed, D.A.; Tanasescu, A.; Toumi, M. A Tolerability Burden Index in Schizophrenia: Incorporating Patient Perspective in Clinical Trial Adverse Event Reporting. J. Mark. Access Health Policy 2017, 5, 1372026. https://doi.org/10.1080/20016689.2017.1372026

AMA Style

François C, Guiraud-Diawara A, Lançon C, Llorca PM, Hartry A, Hammer-Helmich L, Zighed DA, Tanasescu A, Toumi M. A Tolerability Burden Index in Schizophrenia: Incorporating Patient Perspective in Clinical Trial Adverse Event Reporting. Journal of Market Access & Health Policy. 2017; 5(1):1372026. https://doi.org/10.1080/20016689.2017.1372026

Chicago/Turabian Style

François, Clément, Alice Guiraud-Diawara, Christophe Lançon, Pierre Michel Llorca, Ann Hartry, Lene Hammer-Helmich, Djamel A. Zighed, Adrian Tanasescu, and Mondher Toumi. 2017. "A Tolerability Burden Index in Schizophrenia: Incorporating Patient Perspective in Clinical Trial Adverse Event Reporting" Journal of Market Access & Health Policy 5, no. 1: 1372026. https://doi.org/10.1080/20016689.2017.1372026

APA Style

François, C., Guiraud-Diawara, A., Lançon, C., Llorca, P. M., Hartry, A., Hammer-Helmich, L., Zighed, D. A., Tanasescu, A., & Toumi, M. (2017). A Tolerability Burden Index in Schizophrenia: Incorporating Patient Perspective in Clinical Trial Adverse Event Reporting. Journal of Market Access & Health Policy, 5(1), 1372026. https://doi.org/10.1080/20016689.2017.1372026

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