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Open Access Research article

Construct validity of 2 measures to assess reasons for antipsychotic discontinuation and continuation from patients’ and clinicians’ perspectives in a clinical trial

Douglas Faries1*, Haya Ascher-Svanum1, Glenn Phillips1, Allen W Nyhuis1, Tomoko Sugihara2, Virginia Stauffer1 and Bruce J Kinon1

Author Affiliations

1 Eli Lilly and Company, Lilly Corporate Center, DC 5024, Indianapolis, IN, 46285, USA

2 Medfocus, LLC, 8600 West Bryn Mawr Avenue, Chicago, IL, 60631, USA

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BMC Medical Research Methodology 2012, 12:142  doi:10.1186/1471-2288-12-142

Published: 13 September 2012

Abstract

Background

Little is known about the specific reasons for antipsychotic discontinuation or continuation from patients’ or clinicians’ perspectives. This study aimed to assess the construct validity of 2 new measures of the Reasons for Antipsychotic Discontinuation/Continuation (RAD): RAD-I (a structured interview assessing the patient’s perspective) and RAD-Q (a questionnaire assessing the clinician’s perspective).

Methods

Data were used from a 12-week antipsychotic trial of schizophrenia patients in which the RAD was administered at study entry and at study completion (or discontinuation). Construct validity was assessed through comparisons of RAD responses, clinicians’ responses to a standard patient disposition form identifying reasons for patient’s study discontinuation, and several standard psychiatric measures. Percent agreement quantified the correspondence between patient and clinician scores.

Results

Patients indicating lack of improvement/worsening of positive symptoms as a ‘somewhat’ to ‘primary’ reason for medication discontinuation had statistically significantly less improvement in Positive and Negative Syndrome Scale positive score than patients not reporting these as a reason (concurrent validity). Similar results were observed for the RAD negative symptom, functional, social support, and adherence items, whereas the mood and cognitive items were not significantly associated with change scores on standard psychiatric measures. Responses to the RAD were also weakly associated with variables that theoretically should not be related to them (divergent validity). Level of agreement between the clinician- and patient-rated RAD scores was high (60%-100%).

Conclusions

Initial validation of the RAD suggests that the instruments are valid tools for gathering detailed information regarding reasons for antipsychotic discontinuation and continuation from patients’ and clinicians’ perspectives.

Keywords:
Schizophrenia; Concurrent validity; Antipsychotic