Tadashi Kusunoki

Unidimensional scale for dementia

A cognitive test comprising 27 subscales was administered to 262 demented patients and 92 normal subjects. Principal factor analysis followed by varimax and Harris-Kaiser rotation and Guttman’s scalogram analysis was performed. The analysis yielded three factors, i.e. ‘recent memory’, ‘immediate memory or attention’ and ‘remote memory’. The relationships between the three-dimensional distribution of the scores and the DSM-IIIR grade of dementia indicated the existence of a continuum of dementia severity. Scalogram analysis showed unidimensionality in the difficulty level of the subscales as well as in the severity of the cases. Thus, the simple summary score can be used as a good measure of the severity of dementia.

Reliability Study on the Japanese Version of the Clinician’s Interview-Based Impression of Change

The Japanese version of the Clinician’s Interview-Based Impression of Change (CIBIC-plus J) is a semistructured interview format including a 7-point Likert type scale for the Clinician’s Global Impression of Change. It comprises subscales of DAD for ADL, Behave-AD for behavioral and psychiatric symptoms and MENFIS for cognitive and emotional impairment. DAD and Behave-AD are used for caregivers and MENFIS for both caregivers and patients. The objective of this study was to examine the interrater reliability of the CIBIC-plus J by the videotape method. Twenty videotaped patients including 13 real and 7 virtual patients were independently assessed by 11 raters. The kappa coefficient from the full set of data of 20 patients and 11 raters was 0.453, and from the limited data of 13 real patients, 0.383. By permitting one-point disagreements on the 7-point scale or by collapsing it into the 3-point scale (improved, no change, or worsened), kappa improved to 0.894 and 0.731, or 0.734 and 0.504, respectively. From these results, it was concluded that the reliability of a 7-point Clinician’s Global Impression of Change was halfway, i.e., neither sufficient nor insufficient. However, if one-point disagreements or collapsing into 3-point scale are allowable, the CIBIC-plus J will be sufficiently reliable.

Long-term event monitoring study of fluvastatin in Japanese patients with hypercholesterolemia: Efficacy and incidence of cardiac and other events in elderly patients (≥ 65 years old).

OBJECTIVE This long-term event monitoring (LEM) study was designed to evaluate the long-term lipid-lowering efficacy and safety of fluvastatin (Lochol®, Novartis A.G.) along with the incidence of cardiac and other events, and safety of fluvastatin in Japanese patients with hypercholesterolemia. METHODS Patients (n = 21,139) who started fluvastatin between April 1, 2000 and March 31, 2002, across 2563 centers in Japan were prospectively registered and followed up for 3 years (secondary prevention cohort) or 5 years (primary prevention cohort). RESULTS Of the patients registered, 19,084 were included in this analysis. Levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) decreased significantly in the primary (-27.1% and -18.8%) and secondary (-25.3% and -18.4%) prevention cohorts. Reductions in LDL-C (-22.1 vs. -18.2%, p < 0.0001) and TC (-16.1 vs. -13.1%, p < 0.0001) levels were significantly greater among patients aged ≥ 65 than < 65 years old. Overall, 1.7% (146/8563) and 1.1% (93/8563) of patients aged ≥ 65 years old experienced confirmed cardiac and cerebral events, compared with 1.1% (112/10,517) and 0.3% (28/10,517) of patients aged < 65 years old (p = 0.0002 and < 0.0001, respectively). Incidence of cardiac and cerebral events was lowest in patients aged < 65 years old in the primary prevention cohort and highest among patients aged ≥ 65 years old in the secondary prevention cohort. Adverse events were reported in 7.9% (1501/19,084) of patients. CONCLUSION This large-scale, prospective, uncontrolled study confirmed the lipid-lowering efficacy and safety of long-term fluvastatin treatment for hypercholesterolemia in Japanese patients aged ≥ 65 years old. The higher incidence of cardiac and cerebral events in patients aged ≥ 65 years old in the secondary prevention cohort reflects a high-risk clinical profile with multiple classic risk factors warranting multifactorial interventions.

English version of the interim report published in 1998 by the members of the Advisory Committee on Atopic Dermatitis Severity Classification Criteria of the Japanese Dermatological Association

The Japanese Dermatological Association established an advisory committee in 1995 to set up severity scoring systems for atopic dermatitis (AD). Its interim report was published in Japanese in the Japanese Journal of Dermatology (108: 1491–1496, 1998) by Chairman Hikotaro Yoshida. Because of the strong demand for an English version, we have decided to publish the report in English. This prospective study was designed to evaluate the status of 259 AD patients using Method 1, which involves a simple global evaluation of disease severity; Method 2, which involves global evaluation by summing severity scores obtained from five body regions (i.e. the head and neck, anterior and posterior trunks, and upper and lower limbs); Method 3, which consists of both assessment of the extent of involved areas at each of the five body regions and that of the severity scores of each eruption component observed in the most severely affected body region; and Method 4, which consists of the evaluation of only subjective components (daytime pruritus and sleep disturbance). Employing the results obtained with Method 1 as a tentative benchmark, we analyzed its correlation with those of Methods 2, 3 and 4 to statistically assess the validity and reliability of these methods. Method 2, Method 3 and the portion of Method 4 involving evaluation of only the subjective symptom of daytime pruritus but not the sleep disturbance were considered useful in evaluating AD severity.

Hypertension management in diabetic patients: prescribing trends from 1999 to 2005 in three Japanese university hospitals

In hypertensive patients with diabetes, antihypertensive therapy is important in reducing the risk of macro‐ and microvascular complications. In contrast to the guidelines issued by the American Diabetes Association (ADA) in and after 2002, the guidelines issued by the Japanese Society of Hypertension (JSH) in 2000 and 2004 maintained the traditional view that β‐blockers and thiazides should be rated as second‐line drugs. However, both sets of guidelines recommended angiotensin converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) as first‐line agents for such patients.

An application of meta-analysis techniques in the evaluation of adverse experiences with antihypertensive agents.

To investigate the profiles of adverse events (AEs) in randomized controlled trials of antihypertensive agents therapy with the technique of meta‐analysis.

Reliability study on the Japanese version of the Clinician's Interview-Based Impression of Change. Analysis of subscale items and 'clinician's impression'.

Background/Aims: The Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus J) consists of 3 subscales: Disability Assessment of Dementia Scale (DAD), Behavioral Pathology in Alzheimer’s Disease Rating Scale (Behave-AD), and Mental Function Impairment Scale (MENFIS), as well as the Clinician’s Global Impression of Change (CGIC). While the interrater reliability of CGIC has already been reported, that of the 3 subscales has not. The aim of the present report was to examine the reliabilities of the subscale items and investigate their relationships with CGIC. Methods: Eleven raters who were clinical physicians watched videotapes of 20 patients with Alzheimer’s disease, completed the CIBIC-plus J assessment form, and assigned a CGIC score to the patients. Reliability was assessed using the kappa coefficient. Results: The kappa coefficient of the subscale items was in most instances higher than that of CGIC (0.453) and substantial reliability was observed. The Spearman rank correlation that was calculated between CGIC and the total score change of items was very high for MENFIS (0.990) and DAD (0.910), and moderate for Behave-AD items (0.576). The incidence of comments by the raters was highest for MENFIS (89%), followed by DAD (70%). The incidence was low for Behave-AD items (48%). Conclusion:Based on the results, it is concluded that DAD, Behave-AD, and MENFIS are necessary constituents of CIBIC-plus J, and indispensable for the reliability of CGIC.

Reliability of a Rating Scale to Assess Post-stroke Psychiatric Symptoms

Background: Various rating scales for post‐stroke psychiatric symptoms such as cognitive impairment have long been used in drug efficacy trials in Japan. However, their reliability has not been established. The purpose of the present study was to examine the inter‐rater and intra‐rater reliability of a rating scale, which has been conventionally used in Japan.

English version of the concluding report published in 2001 by the Advisory Committee on Atopic Dermatitis Severity Classification Criteria of the Japanese Dermatological Association

The Japanese Dermatological Association established an advisory committee in 1995 to develop a severity scoring system for atopic dermatitis (AD). Its interim and concluding reports were published in Japanese in the Japanese Journal of Dermatology (108: 1491–1496, 1998 and 111: 2023–2033, 2001). Because of the strong demand for an English version, we have decided to publish the reports in English. This manuscript is the English version of the concluding report. The interim report suggested that eruption components such as erythema, papule, erosion, crust, excoriation and lichenification with extent of involved areas in five body regions, including the head and neck, anterior and posterior trunks, and upper and lower limbs, were important items for assessing AD severity. Additionally, it was recommended that streamlining of eruption components was mandatory for improving the statistical validity and reliability. The committee members subsequently concentrated their efforts on this task, and finally proposed an Atopic Dermatitis Severity Classification Criteria of the Japanese Dermatological Association.