Use of the single-item Patient Global Impression-Severity scale as a self-reported assessment of insomnia severity.

We evaluated a single-item Patient Global Impression-Severity (PGI-S) scale for assessing insomnia severity during the clinical development programme for suvorexant. The analyses used data from two randomised, double-blind, placebo-controlled, 3-month, Phase III clinical trials of suvorexant in patients with Diagnostic and Statistical Manual of Mental Disorders IV criteria insomnia. Patients assessed insomnia severity during the previous week using the PGI-S, a one-item questionnaire containing six response options ranging from 0 (none) to 5 (very severe), at baseline and at Week 2, and Months 1, 2, and 3 after randomisation. The seven-item Insomnia Severity Index (ISI) and other subjective and objective assessments were also completed by patients. PGI-S responses were compared primarily with the ISI using descriptive statistics and correlations. The PGI-S demonstrated favourable measurement characteristics (validity, reliability, responsiveness and sensitivity). PGI-S scores decreased from baseline to Month 3 in a similar pattern to the ISI total score, and the Spearman correlation coefficient between PGI-S and the ISI was .73. An improvement of ≥2 points on the PGI-S defined a treatment responder, based on comparison to the ISI definition of a responder (improvement of ≥6 points). Our present findings suggest that the PGI-S is a simple but valid, reliable, responsive, sensitive, and meaningful patient-reported assessment of insomnia severity. The PGI-S may be particularly useful as a companion outcome to sleep monitoring using wearable sleep devices or smartphones in at-home settings.

Rating Patients in Different Languages: Reliability and Validity.

Research outcomes in mental health disciplines are usually assessed using rating instruments that were developed as English language versions. However, in countries such as India, English is not the native language, and patients at even a single research center may speak in different regional tongues. It is permissible to assess such patients using rater-administered English language instruments designed to be scored after an unstructured interview conducted in the patient's preferred language. For many reasons, related to reliability and validity, it is not permissible to assess such patients in their preferred language by translating, impromptu, from English language versions of instruments that were designed to be self-administered or administered as a structured interview. In such situations, standardized, local language versions of the instruments should be used; that is, local language versions with established reliability and validity.

Analyzing rating distributions with heaps and censoring points using the generalized Craggit model.

In this article, we introduce a new, highly flexible model to analyze distributions with heaps and censoring points, which we call the generalized Craggit model. Distributions with heaps and censoring points can be found in many social science applications. For example, such distributions can be the result of sequential or multistep rating processes. Our model is a combination of a Craggit model and a generalized ordered probit model. It can account for multiple heaps and censoring points in distributions. We used this model to analyze a factorial survey experiment on earnings justice attitudes in the SOEP-Pretest 2008. In this experiment, a three-step rating instrument was used, which resulted in a rating distribution with heaps and censoring. Our generalized Craggit model fits the data of this experiment much better than a hierarchical linear model, which is the method that is usually implemented to analyze factorial survey experiments.

Integrating Measurement-Based Care into Trainee Education.

Although there is no published literature on the use of rating scales in child and adolescent psychiatry fellowships, there is evidence of use of rating scales in other residency programs including general psychiatry, pediatrics, and family medicine. The authors surveyed the American Association of Directors of Psychiatric Residency Training listserv inquiring how rating scales are used in child and adolescent psychiatry training programs. Results included the use of specific rating scales, if they are optional or required, presence or absence of didactics, perception of rating instruments by fellows and faculty, integration with quality improvement projects, and use in practice after graduation.

Factor Structure of the Positive and Negative Syndrome Scale (PANSS) Differs by Sex.

Although the Positive and Negative Syndrome Scale (PANSS) is widely used in clinical research, factor analytic studies of the scale have been inconsistent and questions remain about the underlying factor structure of schizophrenia symptoms. The purpose of this study was to examine whether the factor structure of the PANSS differs in men and women with schizophrenia. Principal components analysis (PCA) with equamax rotation was used to examine the factor structure of the PANSS separately in 124 males and 74 females with schizophrenia-related psychoses. In males, a four-factor structure was identified: 1) Negative, 2) Cognitive, 3) Positive, and 4) Hostility. In females, a four-factor structure also emerged: 1) Negative, 2) Cognitive, 3) Positive, and 4) Depression. The most notable difference between the male and female PCAs was the presence of a depression factor in the females and a hostility factor in males. These results support sex differences in the factor structure of schizophrenia symptoms, which has important implications for clinical research.

Abbreviation of the Follow-Up NIH Stroke Scale Using Factor Analysis.

BACKGROUND: The NIH Stroke Scale (NIHSS) is a 15-item measure of stroke-related neurologic deficits that, when measured at 24 h, is highly predictive of long-term functional outcome. We hypothesized that a simplified 24-h scale that incorporates the most predictive components of the NIHSS can retain prognostic accuracy and have improved interrater reliability. METHODS: In a post hoc analysis of the Interventional Management of Stroke-3 (IMS-3) trial, we performed principal component (PC) analysis to resolve the 24-h NIHSS into PCs. In the PCs that explained the largest proportions of variance, key variables were identified. Using these key variables, the prognostic accuracies (area under the curve [AUC]) for good outcome (3-month modified Rankin Scale [mRS] 0-2) and poor outcome (mRS 5-6) of various abbreviated NIHSS iterations were compared with the total 24-h NIHSS. The results were validated in the NINDS intravenous tissue plasminogen activator (NINDS-TPA) study cohort. Based on previously published data, interrater reliability of the abbreviated 24-h NIHSS (aNIHSS) was compared to the total 24-h NIHSS. RESULTS: In 545 IMS-3 participants, 2 PCs explained 60.8% of variance in the 24-h NIHSS. The key variables in PC1 included neglect, arm and leg weakness; while PC2 included level-of-consciousness (LOC) questions, LOC commands, and aphasia. A 3-variable aNIHSS (aphasia, neglect, arm weakness) retained excellent prognostic accuracy for good outcome (AUC = 0.90) as compared to the total 24-h NIHSS (AUC = 0.91), and it was more predictive (p < 0.001) than the baseline NIHSS (AUC = 0.73). The prognostic accuracy of the aNIHSS for good outcome was validated in the NINDS-TPA trial cohort (aNIHSS: AUC = 0.89 vs. total 24-h NIHSS: 0.92). An aNIHSS >9 predicted very poor outcomes (mRS 0-2: 0%, mRS 4-6: 98.5%). The estimated interrater reliability of the aNIHSS was higher than that of the total 24-h NIHSS across 6 published datasets (mean weighted kappa 0.80 vs. 0.73, p < 0.001). CONCLUSIONS: At 24 h following ischemic stroke, aphasia, neglect, and arm weakness are the most prognostically relevant neurologic findings. The aNIHSS appears to have excellent prognostic accuracy with higher reliability and may be clinically useful.

Early perception of medication benefit predicts subsequent antipsychotic response in schizophrenia: "the consumer has a point" revisited.

BACKGROUND: An easy-to-administer tool for predicting response to antipsychotic treatment could improve the acute management of patients with schizophrenia. We assessed whether a patient's perception of medication benefit early in treatment could predict subsequent response or nonresponse to continued use of the same treatment. METHOD: This post hoc analysis used data from a randomized, open-label trial of antipsychotics for treatment of schizophrenia in which attitudes about medication adherence were assessed after two weeks of antipsychotic treatment using the Rating of Medication Influences (ROMI) scale. The analysis included 439 patients who had Positive and Negative Syndrome Scale (PANSS) and ROMI scale data at Weeks 2 and 8. Scores on the ROMI subscale Perceived Medication Benefit factor were used to predict subsequent antipsychotic response at Week 8, defined as a .20% reduction from baseline on the PANSS. Logistic regression was used to identify a cut-off score for the Perceived Medication Benefit factor that could accurately identify antipsychotic responders vs. nonresponders at Week 8. RESULTS: A score of .2.75 (equal to a mean subscale score of .11.00) on the ROMI scale Perceived Medication Benefit factor at Week 2 predicted response at Week 8 with high specificity (72%) and negative predictive value (70%), moderate sensitivity (44%) and positive predictive value (47%), and with a 38% misclassification rate. CONCLUSIONS: A brief assessment of the patient's perception of medication benefit at two weeks into treatment appears to be a good predictor of subsequent response and nonresponse after eight weeks of treatment with the same antipsychotic.