Validation of a clinician questionnaire to assess reasons for antipsychotic discontinuation and continuation among patients with schizophrenia☆
Introduction
When evaluating antipsychotic medication, treatment discontinuation is often considered to be an indicator of overall effectiveness because it incorporates patients' and clinicians' judgments of efficacy and tolerability (Ascher-Svanum et al., 2006, Davis et al., 2003, Dunayevich et al., 2007, Lieberman et al., 2005). Discontinuation is usually quantified as time to treatment discontinuation or rates of discontinuation. These discontinuation variables have been the primary outcomes in key antipsychotic trials (Kahn et al., 2008, Lieberman et al., 2005). Like poor treatment adherence, antipsychotic discontinuation is an important area of research because it is associated with negative outcomes such as relapse, exacerbation of symptoms, and decreased functional status (Dunayevich et al., 2007, Gitlin et al., 2001, Liu-Seifert et al., 2005).
Despite the frequent use of antipsychotic discontinuation as an outcome measure, little is known about specific reasons for discontinuation. Clinical trials usually assess only a single general reason for discontinuation, without capturing the complex interaction among multiple factors leading to the decision to discontinue treatment. Reasons for discontinuation may include insufficient improvement in positive, negative, depressive, or cognitive symptoms; failure to improve functional status; adverse events; financial cost; and psychosocial factors such as lack of social support (Weiden and Ross, 2002). Furthermore, trials do not assess reasons why patients continue medication.
Although measures are available for assessing subjective effects of antipsychotics and influences on treatment compliance (Hogan et al., 1983, Naber, 1995, Weiden et al., 1994), these measures do not identify specific reasons for the decision to continue or discontinue antipsychotic treatment. Specific data on reasons for discontinuation and continuation could improve our understanding of patients' experiences with antipsychotics, while providing guidance for treatment decisions in clinical settings. Consequently, the Reasons for Antipsychotic Discontinuation Questionnaire (RAD-Q) was designed to assess the clinician's perceptions of why treatment with a specific antipsychotic is discontinued or continued. The RAD-Q was developed based on literature review, patient interviews, expert panel input, and cognitive debriefing interviews with clinicians (Matza et al., 2011). The purpose of the current study was to validate the RAD-Q by examining individual item responses, deriving domain scores, and examining reliability and validity of these scores. The RAD-Q includes items assessing reasons for discontinuation or continuation within three domains: treatment benefits, adverse events, and distal reasons other than direct effects of the medication.
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Study design and sample selection
Data were collected in the United States at 17 clinical sites including three Veterans Administration hospitals; seven university hospitals or medical centers; three private healthcare organizations; two private medical research organizations; and two private psychiatric inpatient/outpatient services. Patients diagnosed with schizophrenia or schizoaffective disorder attended one study visit. Patients were categorized as either discontinuation patients or continuation patients. Discontinuation
Patient and clinician characteristics
Data are from 121 patients and their treating clinicians. Patient demographic and clinical characteristics are presented in Table 1. All patients had a diagnosis in their medical chart beginning with the DSM-IV code 295, representing schizophrenia (58.7%) or schizoaffective disorder (41.3%). Of the 121 patients, 81 were discontinuation patients, and 40 were continuation patients. The continuation patients were significantly older than the discontinuation patients (p<0.01). Compared with
Discussion
Current findings provide encouraging initial support for reliability and validity of the RAD-Q. Although analyses of inter-rater reliability should be interpreted with caution due to the small sample of available clinician pairs, results suggest an acceptable degree of agreement between clinicians. Findings also support the validity of the RAD-Q, as indicated by associations with measures of clinician-rated symptoms, interviewer-rated symptoms, and patient-reported adverse events. In addition,
Acknowledgments
The authors thank Jodi Shorr, Julie Meilak, and Aria Gray for production assistance; Meghan Werner and Kimberly Walter for assistance with data collection; and Chris Thompson for statistical programming.
References (24)
- et al.
Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial
Lancet
(2008) - et al.
Development of a clinician questionnaire and patient interview to assess reasons for antipsychotic discontinuation
Psychiatry Research
(2011) Practical Statistics for Medical Research
(1991)- et al.
Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives
Current Medical Research and Opinion
(2010) - et al.
Time to discontinuation of atypical versus typical antipsychotics in the naturalistic treatment of schizophrenia
BMC Psychiatry
(2006) - et al.
The positive and negative syndrome scale and the brief psychiatric rating scale: reliability, comparability, and predictive validity
The Journal of Nervous and Mental Disease
(1992) Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit
Psychological Bulletin
(1968)- et al.
Statistical approaches to effectiveness measurement and outcome-driven re-randomizations in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) studies
Schizophrenia Bulletin
(2003) - et al.
Longer time to antipsychotic treatment discontinuation for any cause is associated with better functional outcomes for patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder
Journal of Clinical Psychiatry
(2007) - et al.
Clinical outcome following neuroleptic discontinuation in patients with remitted recent-onset schizophrenia
American Journal of Psychiatry
(2001)
The Clinical Global Impression-Schizophrenia scale: a simple instrument to measure the diversity of symptoms present in schizophrenia
Acta Psychiatrica Scandinavica (Suppl)
Application of structural equation modeling to health outcomes research
Evaluation & the Health Professions
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Assessing patient-rated vs. clinician-rated adherence to the therapy in treatment resistant schizophrenia, schizophrenia responders, and non-schizophrenia patients
2017, Psychiatry ResearchCitation Excerpt :Despite being more reliable and valid compared with subjective measures, several practical considerations challenge the possibility to use direct monitoring and objective measures in real-world settings, limiting their use to short time-window or to high controlled settings (as in the case of sponsored clinical trials). Therefore, subjective methods are the most-widely employed tools to study medication adherence (Matza et al., 2012), and research in their reliability and consistency are warranted. The goals of the present study were: (1) to evaluate whether patient-rated attitude toward medication was consistent with clinician rating on the patient’s adherence to drug prescription, and which one of these two tools could be more reliable; (2) to define the factors, among a wide set of clinical variables, that associate significantly and may predict adherence in a sample of schizophrenia vs. non-schizophrenia patients, and in the subset of TRS patients among schizophrenia ones; (3) to assess whether adherence may predict psychosocial functioning and quality of life in the samples of patients described above, since insight has been report to contribute to quality of life in stable schizophrenia (Rocca et al., 2010), possibly via the mediator effect of cognitive functioning (Sigaudo et al., 2014).
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This study was funded by Eli Lilly and Company.