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Initial development of a patient-reported outcome measure of experience with cognitive impairment associated with schizophrenia

Authors Welch LC, Trudeau JJ, Silverstein SM, Sand M, Henderson DC, Rosen RC

Received 27 September 2016

Accepted for publication 6 March 2017

Published 8 June 2017 Volume 2017:8 Pages 71—81


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Dr Liana Bruce (formerly Castel)

Video abstract presented by Lisa C Welch, Michael Sand, and Raymond C Rosen

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Lisa C Welch,1 Jeremiah J Trudeau,2 Steven M Silverstein,3 Michael Sand,4 David C Henderson,5 Raymond C Rosen6

1Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, MA, 2Health Economics and Outcomes Research, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, 3University Behavioral Health Care, Department of Psychiatry, Rutgers University, Piscataway, NJ, 4Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, 5Boston Medical Center, School of Medicine, Boston Univeristy, Boston, 6Epidemiology, New England Research Institutes, Watertown, MA, USA

Abstract: Cognitive impairment is a serious, often distressing aspect of schizophrenia that affects patients’ day-to-day lives. Although several interview-based instruments exist to assess cognitive functioning, a reliable measure developed based on the experiences of patients facing cognitive difficulties is needed to complement the objective performance-based assessments. The present article describes the initial development of a patient-reported outcome (PRO) measure to assess the subjective experience of cognitive impairment among patients with schizophrenia, the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS). The phases of development included the construction of a conceptual model based on the existing knowledge and two sets of qualitative interviews with patients: 1) concept elicitation interviews to ensure face and content validity from the perspective of people with schizophrenia and 2) cognitive debriefing of the initial item pool. Input from experts was elicited throughout the process. The initial conceptual model included seven domains. The results from concept elicitation interviews (n=80) supported these domains but yielded substantive changes to concepts within domains and to terminology. Based on these results, an initial pool of 53 items was developed to reflect the most common descriptions and languages used by the study participants. Cognitive debriefing interviews (n=22) resulted in the removal of 18 items and modification of 22 other items. The remaining 35 items represented 23 concepts within six domains plus two items assessing bother. The draft PRO measure is currently undergoing psychometric testing as a precursor to broad-based clinical and research use.

Keywords: cognition, subjective experience, qualitative methods, face validity, content validity, disability, mental disorder

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