The O'Leary-Sant Interstitial Cystitis Symptom Index is a clinically useful indicator of treatment outcome in patients with interstitial cystitis/bladder pain syndrome with Hunner lesions: A post hoc analysis of the Japanese phase III trial of KRP-116D, 50% dimethyl sulfoxide solution.

OBJECTIVES: To evaluate the efficacy of intravesical KRP-116D, 50% dimethyl sulfoxide solution, in interstitial cystitis/bladder pain syndrome patients with Hunner lesions (Hunner-type interstitial cystitis), and to evaluate the correlations between efficacy variables and global response assessment to determine what constitutes a minimal clinically important change. METHODS: We performed a post hoc analysis of the Japanese phase III trial of KRP-116D. Changes at Week 12 from baseline in objective and subjective outcomes were compared between the KRP-116D and placebo groups in Hunner-type interstitial cystitis or non-Hunner-type interstitial cystitis patients. Correlations between efficacy variables at Week 12 and global response assessment were analyzed. Area under the receiver operating characteristic curve and the cut-off value of efficacy valuables were calculated to determine clinically meaningful changes. RESULTS: The effectiveness of intravesical treatment with KRP-116D was demonstrated in Hunner-type interstitial cystitis, but not in non-Hunner-type interstitial cystitis patients. Global response assessment was closely correlated with subjective outcomes including O'Leary-Sant Interstitial Cystitis Symptom Index, O'Leary-Sant Interstitial Cystitis Problem Index, and a numeric rating scale for bladder pain, but was less correlated with voiding variables including micturition frequency, voided volume, and maximum voided volume. In the receiver operating characteristic curve analyses, the cut-off value for the O'Leary-Sant Interstitial Cystitis Symptom Index was -5 (sensitivity 81.3%, specificity 83.3%). CONCLUSIONS: Clinical benefit of intravesical KRP-116D in Hunner-type interstitial cystitis patients was confirmed in this post hoc analysis. A five-point reduction in O'Leary-Sant Interstitial Cystitis Symptom Index is a clinically meaningful indicator for assessing patient satisfaction with KRP-116D treatment in patients with Hunner-type interstitial cystitis.

Do staffing levels determine outcome in psychiatric inpatient care? - Factors related to the ratio of period hospitalized in Japan.

The aim of this study was to determine the factors related to outcome, as measured by the cumulative number of days hospitalized, of a cohort group of inpatients with a diagnosis of schizophrenia followed up for 6 years. Comprehensive data were obtained from 18 psychiatric hospitals from two surveys conducted in 1993 and 1999. Outcome was evaluated by calculating the cumulative number of days between the two surveys that the cohort group was hospitalized. Tree-based models analysis was used to explore the factors related to outcome. Patient characteristics at the time of the first survey that were related to outcome were the number of days hospitalized, cumulative number of years hospitalized, age, Global Assessment of Functioning score and relationship to the main visitor. The number of beds in each hospital and changes in their number were also related. Increasing staffing levels is not likely to impact on deinstitutionalization since their levels were not related to outcome.

Factors related to prescription dosage in Japanese psychiatric hospitals.

A point prevalence study of prescription dosage was made among psychiatric inpatients in Japan with the following aims: (i) to analyze whether total chlorpromazine equivalent dose was related to patient characteristics or hospital and physician characteristics; and (ii) to analyze whether the usage of the two major categories of antipsychotics, butyrophenone and phenothiazine, were related to their expected pharmacological reactions. A comprehensive database of prescription contents and characteristics of patients, physicians and hospitals was developed from a survey of 1674 patients in 18 psychiatric hospitals. Using the tree-based model analysis, factors related to the total chlorpromazine equivalent dose were analyzed. Factors included hospital ownership, staffing levels, physician specialty and patient length of stay, symptoms etc. The same analysis was then done for the two major categories of antipsychotics, in order to evaluate whether their expected pharmacological reactions were related to their usage. Factors related to the total chlorpromazine equivalent dose were age of patient, presence of hallucination, age of first psychiatric hospitalization, and change(s) in attending physician (while hospitalized). For the chlorpromazine equivalent dose of the butyrophenone category, the clinical factors related were abnormality in thought and hallucination, and for the phenothiazine category, it was bizarre behavior. Total chlorpromazine equivalent doses had no relationship with hospital or physician characteristics, and appeared to be determined by patient age and psychiatric symptoms. Doses in the butyrophenone category were related to pathological experiences and that in the phenothiazine category to behavioral aspects.