https://orcid.org/0000-0003-4254-4420
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Abstract
Background
Generic health-related quality of life (HRQoL) scales are increasingly being used to assess the effects of new treatments in schizophrenia. The objective of this study is to better understand the usefulness of generic and condition specific HRQoL scales in schizophrenia by analyzing their correlates.
Methods
Data formed part of the Pattern study, an international observational study among 1379 outpatients with schizophrenia. Patients were evaluated with the Mini International Neuropsychiatric Inventory, the Clinical Global Impression-Schizophrenia (CGI-SCH) Scale and the Positive and Negative Syndrome Scale (PANSS) and reported their HRQoL using the Schizophrenia Quality of Life Scale (SQLS), the Short Form-36 (SF-36), and the EuroQol-5 Dimension (EQ-5D). The two summary values of the SF-36 (the Mental Component Score and the Physical Component Score, SF-36 MCS and SF-36 PCS) were calculated.
Results
Higher PANSS positive dimension ratings were associated with worse HRQoL for the SQLS, EQ-5D VAS, SF-36 MCS, and SF-36 PCS. Higher PANSS negative dimension ratings were associated with worse HRQoL for the EQ-5D VAS, SF-36 MCS, and SF-36 PCS, but not for the SQLS or the EQ-5D tariff. PANSS depression ratings were associated with lower HRQoL in all the scales. There was a high correlation between the HRQoL scales. However, in patients with more severe cognitive/disorganized PANSS symptoms, the SQLS score was relatively higher than the EQ-5D tariff and SF-36 PCS scores.
Conclusion
This study has shown substantial agreement between three HRQoL scales, being either generic or condition specific. This supports the use of generic HRQoL measures in schizophrenia.
Clinicaltrials.gov identifier
NCT01634542 (July 6, 2012, retrospectively registered).
Acknowledgements
We want to thank all participating patients, families, and clinicians. We thank Jaume Aguado for his help with the statistical analysis and Ellen Vorstenbosch for her critical review of the manuscript.
Abbreviations
CGI-SCH, Clinical Global Impression-Schizophrenia; EQ-5D, EuroQol-5 Dimension; EQ-5D VAS, EQ-5D visual analogue scale; HRQoL, Health-related quality of life; PANSS, Positive and Negative Syndrome Scale; PCC, Pearson Correlation Coefficient; PRO, Patient-reported outcome; SF-36, Short Form-36; SF-36 MCS, SF-36 mental component score; SF-36 PCS, SF-36 physical component score; SQLS, Schizophrenia Quality of Life Scale.
Ethics Approval
The protocol and consent procedures of the original study were approved by all local Institute Review Boards/Ethics Committees before study initiation. All patients and caregivers provided written informed consent. This project was approved by the Fundació Sant Joan de Déu Ethics Committee.
Data Sharing Statement
Roche provides qualified researchers access to individual patient level data. Details for Roche’s Data Sharing Policy are available from the corresponding author on reasonable request.
Author Contributions
CD designed the study, Conducted the statistical analysis and produced the first version of the manuscript. ACA, CB, RC, HE, JE, AM, MOK, ALN, MZ, and JMH participated in the study design, data collection and critically revised the manuscript for important intellectual content. AP and FM participated in data analysis and interpretation and revised the manuscript for important intellectual content. All authors approved the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of the work are appropriately investigated and resolved.
Disclosure
Carlo Altamura has served as a consultant or advisory board member for F. Hoffmann- La Roche, Ltd., Lundbeck, Merck, Astra Zeneca, Bristol Myers Squibb, Janssen-Cilag, Sanofi, Eli Lilly, Pfizer and Otsuka. Corrado Bernasconi is a contractor of F. Hoffmann- La Roche, Ltd. Helio Elkis has received research grants from the São Paulo Research Foundation (FAPESP), Janssen-Cilag and Roche, participated on advisory boards for Janssen-Cilag and Roche, and received honoraria and travel support from Janssen-Cilag and Roche. Ashok Malla has received honoraria or participated in advisory boards or educational conferences or received research funding for investigator-initiated projects from Janssen Canada, Pfizer Canada, Bristol-Myers-Squib, F. Hoffmann- La Roche, Ltd., Otsuka, Lundbeck and Astra-Zeneca. Francesco Margari has no conflict of interest. Anna-Lena Nordstroem is an employees of F. Hoffmann- La Roche, Ltd. Mathias Zink has received unrestricted scientific grants from the European Research Advisory Board, German Research Foundation, Servier, Pfizer Pharma GmbH, Bristol-Myers Squibb GmbH & CoKGaA, further speaker and travel support from Pfizer Pharma GmbH, Bristol-Myers Squibb, Otsuka, Astra Zeneca, Eli-Lilly, Janssen Cilag, Servier, Trommsdorff and F. Hoffmann- La Roche Ltd. Marie-Odile Krebs has received honoraria and participated in advisory boards F. Hoffmann- La Roche, Ltd. Josep Maria Haro has acted as a consultant, participated in advisory boards or given educational presentations for Eli Lilly and Co., Lundbeck, Otsuka, F. Hoffmann- La Roche Ltd. and Takeda. The authors report no other conflicts of interest in this work.