Validation of computer-administered clinical rating scale: Hamilton Depression Rating Scale assessment with Interactive Voice Response technology--Japanese version.

AIM: The aim of this study was to examine the reliability and validity of the Interactive Voice Response (IVR) program to rate the 17-item Hamilton Rating Scale for Depression (HAM-D) score in Japanese depressive patients. METHODS: Depression severity was assessed in 60 patients by a clinician and psychologists using HAM-D. Scoring by the IVR program was conducted on the same and the following days. Test-retest reliability, internal consistency, and concurrent validity for total HAM-D scores were examined by calculating intraclass correlation coefficient, Cronbach's alpha, and Pearson's correlation coefficient. Inter-rater consistency for each HAM-D item was examined by Cohen's kappa. RESULTS: Test-retest reliability of the IVR program was high (intraclass correlation coefficient: 0.93). Internal consistency of each total score obtained by the clinician, psychologists, and IVR program was high (Cronbach's alpha: 0.77, 0.79, 0.78, and 0.83). Regarding concurrent validity, correlation coefficients between total scores obtained by the clinician versus IVR and that by the clinician versus psychologists were high (0.81 and 0.93). The HAM-D total score rated by the clinician was 3 points lower than that of IVR. Inter-rater consistency for each HAM-D item evaluated by the clinician versus IVR was estimated to be fair (Cohen's kappa coefficient: 0.02-0.50). CONCLUSION: Our results suggest that the Japanese IVR HAM-D program is reliable and valid to assess 17-item HAM-D total score in Japanese depressive patients. However, the current program tends to overestimate depression severity, and the score of each item did not always show high agreement with clinician's rating, which warrants further improvement in the program.

Single-Dose Pharmacokinetics of the CCR9 Receptor Antagonist Vercirnon in Healthy US and Japanese Subjects.

Two randomized, single-dose, crossover studies were carried out to assess different formulations and doses of the CCR9 receptor antagonist vercirnon in healthy subjects. US study (n = 24): a five-period crossover study in healthy US subjects to assess the bioavailability of four new GlaxoSmithKline formulations compared with a "reference" formulation. Each subject received a single 500 mg dose of each of the five vercirnon formulations in a fed state. Primary pharmacokinetic (PK) endpoints were maximum plasma concentration, (Cmax ), and exposure as assessed by area under the curve (AUC). There was no significant difference in PK parameters and bioavailability between the formulations tested. Japanese study (n = 30): a four-period crossover study in healthy Japanese male subjects to assess PK and dose proportionality following single, ascending, oral doses of 250, 500, and 1,000 mg vercirnon under fasted and fed conditions. Vercirnon Cmax and AUC parameters in the fasted state increased in a less than dose proportional manner and were on average 20% higher in fed subjects compared with fasted subjects. Overall, these results support the premise that vercirnon has similar PK/safety profiles within US and Japanese populations. There was no evidence to preclude the use of the new vercirnon formulation in future studies.

Validation of the care notebook for measuring physical, mental and life well-being of patients with cancer.

To measure patients' QOL in the daily practice of clinical oncology, we developed and tested the Care Notebook. This instrument has 24 questions expressed in single words or short phrases to make it more acceptable to patients. The Care Notebook, EORTC QLQ-C30 and FACIT-Sp-12 were administered to 249 outpatients with cancer. Construct validity was investigated by cluster analysis and multitrait scaling analysis. The results showed that three scales (physical well-being, mental well-being, and life well-being) could explain 55% of the variance in scores. The life well-being scale could be divided into subscales of Daily Functioning, Social Functioning, and Subjective QOL. Multitrait scaling analysis confirmed convergent and discriminant validity of these scales and subscales. Internal consistency and test-retest reliability were favorable. Differences in Care Notebook scores were also consistent with differences in performance status rating (known-groups validity), and Care Notebook scores correlated with EORTC QLQ-C30 and FACT-Sp-12 scores (concurrent validity). The Care Notebook allows clinical oncologists to easily collect valid and reliable QOL information of physical, mental, and life well-being repeatedly and with minimal burden on patients.