Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response.

OBJECTIVE: This study investigated the suitability of the Montgomery-Asberg Depression Rating Scale (MADRS), with a 24-hour recall period (MADRS-24hr), to assess the rapid onset of the antidepressant effect of a treatment in patients with treatment-resistant depression (TRD). Psychometric properties of the MADRS-24hr were assessed together with qualitative assessment of content validity. METHODS: Content validity was assessed using semistructured interviews conducted from November 2013 to December 2013 in patients (18-64 years old) with TRD who met DSM-IV diagnostic criteria and health care professionals (HCPs) experienced in treating major depressive disorder and familiar with using the MADRS. The psychometric properties of MADRS-24hr were evaluated using data from 2 randomized clinical studies involving patients with TRD. RESULTS: A total of 23 patients (15 [65%] women) with TRD (mean age = 45 years) and 11 HCPs were interviewed. With the exception of reduced sleep, the majority of patients and HCPs reported that the items captured in the MADRS can fluctuate in a 24-hour period. The majority of participants also reported that a meaningful change in depression symptoms could be assessed in a 24-hour recall period, except for reduced sleep and appetite. Assessment of the psychometric properties of the MADRS-24hr showed that this instrument had high internal consistency reliability (Cronbach α of 0.84 and 0.91) and test-retest reliability (intraclass correlation coefficients of 0.96 and 0.91), had construct validity, and was responsive to change following an intervention. CONCLUSIONS: Overall, results suggest that MADRS-24hr can be used to assess the rapid onset of antidepressant efficacy of a treatment in patients with TRD. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01627782 and NCT01640080.

Reliability, validity, and interpretation of the dependence scale in mild to moderately severe Alzheimer's disease.

INTRODUCTION: The Dependence Scale (DS) was designed to measure dependence on others among patients with Alzheimer's disease (AD). The objectives of this research were primarily to strengthen the psychometric evidence for the use of the DS in AD studies. METHODS: Patients with mild to moderately severe AD were examined in 3 study databases. Within each data set, internal consistency, validity, and responsiveness were examined, and structural equation models were fit. RESULTS: The DS has strong psychometric properties. The DS scores differed significantly across known groups and demonstrated moderate to strong correlations with measures hypothesized to be related to dependence (|r| ≥ .31). Structural equation modeling supported the validity of the DS concept. An anchor-based DS responder definition to interpret a treatment benefit over time was identified. DISCUSSION: The DS is a reliable, valid, and interpretable measure of dependence associated with AD and is shown to be related to--but provides information distinct from--cognition, functioning, and behavior.

Item selection, reliability and validity of the Shortness of Breath with Daily Activities (SOBDA) questionnaire: a new outcome measure for evaluating dyspnea in chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterized by irreversible, progressive obstruction of lung airflow. Dyspnea (shortness of breath [SOB]) is the COPD symptom which most negatively impacts patients' daily activities. To assess how SOB affects daily activities, 37 items were drafted through focus group discussions and cognitive interviews with COPD patients to develop a patient-reported outcome instrument: the Shortness of Breath with Daily Activities questionnaire (SOBDA). Psychometric analysis was conducted to reduce the number of items and evaluate the measurement properties of the final SOBDA. METHODS: Prospective, observational study of 334 COPD patients, recruited from 24 pulmonology and internal medicine clinics in the United States. The 37-item SOBDA was administered to patients each evening for 28 days using an electronic diary. Patients answered every item and rated their level of SOB experienced that day during specific activities. Item selection was conducted by examining item characteristics, dimensionality, and Rasch model analysis results. The decision to delete an item was based on psychometric evidence, content validity, and expert clinical input. The final SOBDA instrument was evaluated for internal consistency, reproducibility, convergent validity, known-groups validity, and responsiveness. RESULTS: Twenty-four items from the 37-item pool were removed following the item selection process: nine items were removed due to high item-to-item correlations; five due to floor effects; three due to infrequent activity; one due to gender bias; two due to low factor loadings; three due to unordered response options; and one due to expert's discretion. Internal consistency and reproducibility of the final SOBDA were demonstrated by Cronbach Alpha = 0.87, and intra-class correlation coefficient = 0.91. Convergent validity was demonstrated by high correlation with the CRQ-SAS (0.60) and SGRQ-C (0.61). Known groups validity was demonstrated by significant difference between ratings of the mMRC and clinical global rating of severity. Evaluation of the ability to detect change was not performed owing to too few responders at the end of the study. CONCLUSIONS: Through the empirical item reduction process, 13 items were selected from the 37-item pool generated during qualitative development. The final 13-item SOBDA is a reliable and valid instrument for use in clinical trials.

Undertreatment of osteoporosis in residents of nursing homes: population-based study with use of the Systematic Assessment of Geriatric Drug Use via Epidemiology (SAGE) database.

OBJECTIVE: To determine the proportion of nursing home residents >65 years of age with osteoporosis who were receiving antiosteoporosis pharmacotherapy and to identify the predictors of administration of such drugs. METHODS: We identified 29,357 patients with osteoporosis documented on the Minimum Data Set collected on residents of all nursing home facilities in 5 states during the period from 1992 through 1996. A multiple logistic regression model was used for analysis, with the dependent variable being use of any antiosteoporosis drug. RESULTS: Among the nursing home residents with osteoporosis, 25% received antiosteoporosis drugs. Women were more likely than men to receive antiosteoporosis drugs (adjusted odds ratio [OR], 1.41; 95% confidence interval [CI], 1.26 to 1.57). Both increasing age and level of cognitive impairment were inversely related to receipt of antiosteoporosis drugs. A history of fracture or falls was not predictive of use of such drugs. Treatment was less likely for nursing home residents with > or = 6 medical conditions (OR 0.55, 95% CI 0.51 to 0.59); those admitted to a nursing home from a hospital (OR 0.86, 95% Cl 0.80 to 0.92); and those with a terminal prognosis (OR 0.60,95% CI 0.42 to 0.87). CONCLUSION: The majority of nursing home residents with osteoporosis in this study did not receive drug therapy for this disabling and treatable disease. Although acceptable reasons may exist in some of these residents,others--especially the oldest old--may not be receiving adequate care.