Development of a clinician questionnaire and patient interview to assess reasons for antipsychotic discontinuation.

Time to treatment discontinuation and rates of discontinuation are commonly used when evaluating effectiveness of antipsychotic medication. However, less is known about reasons for discontinuation. The purpose of this study was to develop two measures of reasons for discontinuation or continuation of antipsychotics for the treatment of schizophrenia. Based on literature review, a patient interview pilot study, and expert panel input, two measures were drafted: the clinician-reported Reasons for Antipsychotic Discontinuation/Continuation Questionnaire (RAD-Q) and the patient-reported Reasons for Antipsychotic Discontinuation/Continuation Interview (RAD-I). Patients and clinicians completed the draft measures and structured cognitive debriefing interviews. For the draft instruments, reasons for discontinuation/continuation were divided into 3 categories: therapeutic benefits (positive symptoms, negative symptoms, mood, cognition, functional status), adverse events, and reasons other than direct effects of the medication (e.g., cost, inadequate social support). In cognitive debriefings, 10 clinicians and 15 patients indicated that the RAD-Q and RAD-I were clear, easy to complete, and comprehensive. Clinicians and patients suggested minor revisions, and the instruments were revised accordingly. The RAD-Q and RAD-I appear to be useful instruments for assessing reasons for antipsychotic discontinuation and continuation. The next step is a psychometric evaluation of the measures in a larger sample.

Obese versus non-obese patients with type 2 diabetes: patient-reported outcomes and utility of weight change.

INTRODUCTION: This study (1) used patient-reported outcome measures to assess and compare the health status of type 2 diabetes patients with and without obesity and (2) assessed the value of weight change among obese and non-obese subgroups, using standard gamble (SG) utility methodology. METHODS: Among a sample with type 2 diabetes in the United Kingdom, individuals with obesity (BMI > or = 30 kg/m2) were identified and compared to non-obese patients. Patients completed the EQ-5D, Psychological General Well-Being Index, Appraisal of Diabetes Symptoms, and Diabetes Symptom Checklist-Revised (DSC-R). SG interviews assessed the utility of the 'basic' type 2 diabetes health state anchored to respondents' body weight, as well as health states with altered weight. RESULTS: A total of 129 patients (74 obese; 55 non-obese) completed interviews (mean age 55.9 years; 64.3% male). Obese patients reported lower health status (EQ-5D VAS; between-group difference: p < 0.001) and greater symptom impact (several DSC-R scales, p < 0.05). Utilities of the basic health state were 0.86 (obese) and 0.91 (non-obese; p = 0.02). Hypothetical health states with higher weight received lower utilities, whereas reduced weight was associated with increased utility. There was a between-group difference in the disutility associated with 5% higher weight (obese 0.068; non-obese 0.051; p = 0.03). DISCUSSION: Compared with non-obese patients, the obese group reported lower health status and greater symptom impact. SG interviews found an inverse relationship between weight and utility. Furthermore, obese patients with type 2 diabetes may value weight change differently than non-obese patients. Study limitations include the sample size and the use of a patient sample, rather than a sample selected from the general population. Overall, the results demonstrate that utilities can differ by patient subgroups, even among patients with the same diagnosis.

Utilities and disutilities for type 2 diabetes treatment-related attributes.

INTRODUCTION: Although cost-utility analyses are frequently used to estimate treatment outcomes for type 2 diabetes, utilities are not available for key medication-related attributes. The purpose of this study was to identify the utility or disutility of diabetes medication-related attributes (weight change, gastrointestinal side effects, fear of hypoglycemia) that may influence patient preference. METHODS: Patients with type 2 diabetes in Scotland and England completed standard gamble (SG) interviews to assess utility of hypothetical health states and their own current health state. The EQ-5D, PGWB, and Appraisal of Diabetes Symptoms were administered. Construct validity and differences among health states were examined with correlations, t-tests, and ANOVAs. RESULTS: A total of 129 patients (51 Scotland; 78 England) completed interviews. Mean utility of diabetes without complications was 0.89. Greater body weight was associated with disutility, and lower body weight with added utility (e.g., 3% higher = -0.04; 3% lower = +0.02). Gastrointestinal side effects and fear of hypoglycemia were associated with significant disutility (p < 0.001). SG utility of current health (mean = 0.87) demonstrated construct validity through correlations with patient-reported outcome measures (r = 0.08-0.31). DISCUSSION: The vignette-based approach was feasible and useful for assessing added utility or disutility of medication-related attributes.

Impact of atomoxetine on health-related quality of life and functional status in patients with ADHD.

In children and adults, attention-deficit hyperactivity disorder is strongly associated with impairment in health-related quality of life as well as social, academic and occupational functioning. Thus, evaluation of treatment for attention-deficit hyperactivity disorder should assess the impact on functional status and health-related quality of life as well as potential symptom improvement. Atomoxetine is a relatively new nonstimulant medication indicated for the treatment of attention-deficit hyperactivity disorder in children and adults. The purpose of the current paper is to review studies examining the functional and health-related quality of life outcomes of atomoxetine treatment. Studies in this review included four types of measures: generic health-related quality of life instruments, condition-specific health-related quality of life instruments, functional status measures and utility-based assessments. A literature search identified 11 relevant outcome studies and two additional studies using a utility approach. Among children and adolescents, atomoxetine was associated with greater benefits than placebo on generic and condition-specific health-related quality of life measures (domains included children's behavior, mental health, self-esteem and parental impact) as well as measures of classroom behavior and evening behavior. Although findings from adult trials were not as consistent, initial results suggest that adults may also experience functional improvement (e.g., work, social and family functioning) associated with atomoxetine treatment. Overall, findings provide compelling support for the hypothesis that treatment of attention-deficit hyperactivity disorder can have broad positive effects beyond symptom improvement. Studies with active comparators are needed to determine whether the health-related quality of life benefits of atomoxetine are superior or comparable to those of stimulant medications.