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Symptoms of schizophrenia fall into three categories (positive, negative and cognitive symptoms), which probably impact differently on patient’s health-related quality of life (HRQoL). The present study aimed to explore HRQoL in patients with prominent negative symptoms.
In the 323 patients with prominent negative symptoms included in a multicenter Phase II trial investigating the safety and efficacy of bitopertin, HRQoL was assessed using the Schizophrenia Quality of Life Scale (SQLS), symptoms severity using the Positive and Negative Syndrome Scale and functioning using the Personal and Social Performance Scale. SQLS measurement properties were assessed; HRQoL was compared between treatment arms, and relationships between HRQoL, symptoms and functioning at baseline were explored.
Both SQLS scores (Vitality/Cognition and Psychosocial Feelings) demonstrated good test–retest (ICC = 0.77 and 0.74) and internal consistency reliability (Cronbach’s α = 0.86 and 0.93). Clinical validity with regard to schizophrenia severity and ability to detect change in severity of symptoms of schizophrenia were satisfactory. The SQLS structure was not formally disconfirmed. No statistically significant difference was observed between treatment arms. Negative symptoms were more strongly associated with functioning than positive symptoms. Functioning and Anxiety/Depression were strongly related to both SQLS domains.
Overall, SQLS measurement properties were supported in these patients with prominent negative symptoms of schizophrenia. The impact of negative symptoms on functioning and HRQoL suggests that improving these symptoms will be a meaningful benefit in this population of patients.
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U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. (2009). Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf
McCabe, R., Saidi, M., & Priebe, S. (2007). Patient-reported outcomes in schizophrenia. British Journal of Psychiatry. Supplement,50, s21–s28. CrossRef
Noetzel, M. J., Jones, C. K., & Conn, P. J. (2012). Emerging approaches for treatment of schizophrenia: Modulation of glutamatergic signaling. Discovery of Medicine,14(78), 335–343.
Pinard, E., Alanine, A., Alberati, D., Bender, M., Borroni, E., Bourdeaux, P., et al. (2010). Selective GlyT1 inhibitors: discovery of [4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl][5-methanesulfonyl-2-((S)-2,2,2-trifluoro-1-methylethoxy)phenyl]methanone (RG1678), a promising novel medicine to treat schizophrenia. Journal of Medicinal Chemistry,53(12), 4603–4614. PubMedCrossRef
Patrick, D. L., Burns, T., Morosini, P., Rothman, M., Gagnon, D. D., Wild, D., et al. (2009). Reliability, validity and ability to detect change of the clinician-rated Personal and Social Performance scale in patients with acute symptoms of schizophrenia. Current Medical Research and Opinion,25(2), 325–338. PubMedCrossRef
Schumacker, R. E., & Lomax, R. G. (1996). A beginner’s guide to structural equation modeling. Mahwah, NJ: Lawrence Erlbaum Associates.
Chassany, O., Sagnier, P., Marquis, P., Fullerton, S., & Aaronson, N. (2002). Patient-reported outcomes: The example of health-related quality of life: A European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Information Journal,36, 209–238. CrossRef
Zumbo, B. D. (1999). A handbook on the Theory and Methods of Differential Item Functioning (DIF): Logistic Regression Modeling as a Unitary Framework for Binary and Likert-type (Ordinal) Item Scores. Ottawa, ON: Directorate of Human Resources Research and Evaluation, Department of National Defense.
Gelin, M. N., & Zumbo, B. D. (2003). Differential Item Functioning results may change depending on how an item is scored: an illustration with the Center for Epidemiologic Studies Depression Scale. Educational and Psychological Measurement,63(1), 65–74. CrossRef
Jodoin, M. G., & Gierl, M. J. (2001). Evaluating Type I error and power rates using an effect size measure with the logistic regression procedure for DIF detection. Applied Measurement in Education,14, 329–349. CrossRef
Hays, R. D., Anderson, R. & Revicki, D. (1998). Assessing reliability and validity of measurement in clinical trials. In Quality of life assessment in clinical trials: Methods and practice (pp. 169–182). Oxford: Oxford University Press.
Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric theory. New York: McGraw-Hill Inc.
Cohen, J. (1977). Statistical power analysis for the behavioral sciences. New York: Academic Press.
Kline, R. B. (2005). Principle and practice of structural equation modeling. New York: Guilford Press.
Arango, C., Nasrallah, H., Lawrie, S., Ochi Lohmann, T., Zhu, J., Garibaldi, G., et al. (2013) Efficacy and safety of adjunctive bitopertin (5 and 10 mg) versus placebo in subjects with persistent predominant negative symptoms of schizophrenia treated with antipsychotics—Results from the Phase III DayLyte study. In 4th Biennial Schizophrenia International Research Society Conference, 5–9 April 2013. Florence, Italy.
Blaetter, T., Bugarski-Kirola, D., Fleischhacker, W. W., Bressan, R. A., Arango, C., Abi-Saab, D., et al. (2013). Efficacy and safety of adjunctive bitopertin (10 and 20 mg) versus placebo in subjects with persistent predominant negative symptoms of schizophrenia treated with antipsychotics—Results from the Phase III FlashLyte Study. In 4th Biennial Schizophrenia International Research Society Conference, 5–9 April 2013. Florence, Italy.
Taha, N. A., Ibrahim, M. I., Rahman, A. F., Shafie, A. A., & Rahman, A. H. (2012). Validation of the Schizophrenia Quality of Life Scale Revision 4 among Chronic Schizophrenia Patients in Malaysia. Value in Health Regional Issues,1(1), 82–86. CrossRef
Wilkinson, G., Clayson, D., Wild, D., Doll, H., Martin, C., & De Hert, M. (2004) The development and psychometric validation of the Schizophrenia Quality of Life Scale-revision 4 (SQLS-R4). Abstracts of the XIIth Biennal Winter Workshop on Schizophrenia. Schizophrenia Research. July 2, 2004.
Lipkovich, I. A., Deberdt, W., Csernansky, J. G., Sabbe, B., Keefe, R. S., & Kollack-Walker, S. (2009). Relationships among neurocognition, symptoms and functioning in patients with schizophrenia: A path-analytic approach for associations at baseline and following 24 weeks of antipsychotic drug therapy. BMC Psychiatry,9, 44. PubMedPubMedCentralCrossRef
- Health-related quality of life in patients with prominent negative symptoms: results from a multicenter randomized Phase II trial on bitopertin
Stéphanie le Scouiller
Carmen Galani Berardo
- Springer International Publishing