A report on small team clinical ethics consultation programmes in Japan.

Clinical ethics support, including ethics consultation, has become established in the field of medical practice throughout the world. This practice has been regarded as useful, most notably in the UK and the USA, in solving ethical problems encountered by both medical practitioners and those who receive medical treatment. In Japan, however, few services are available to respond to everyday clinical ethical issues, although a variety of difficult ethical problems arise daily in the medical field: termination of life support, euthanasia and questions about patient autonomy. In light of these conditions, a group of 17 volunteer educators and researchers from the area of biomedical ethics, including the authors, have formed the Clinical Ethics Support and Education Project, and began providing Japan's first small team clinical ethics consultation service in October, 2006. Members include scholars of biomedical ethics, scholars of philosophy and ethics, legal professionals and legal scholars, nurses and doctors, consisting of five women and 12 men. Consultation teams, made up of a small number of members, were organised each time a request for consultation was received. Over approximately 15 months (October 2006-December 2007), the programme received 22 consultation requests from medical practitioners and medical institutions, and three from the families of patients. In this paper, we will discuss the status of our consultation service and examples of consultation cases we have handled. In addition, we will examine the process of evaluating small team clinical ethics consultation services, as well as the strengths and weakness of such programmes.

Relationship between having a home doctor and outpatient utilization.

While universal insurance coverage should eliminate or substantially reduce financial and certain structural barriers to medical care, inequity in utilization of care may continue to exist. We conducted a questionnaire survey of a national random sample of 4500 Japanese age 16 or over in October, 1995. Separate analyses were conducted to predict the physician visit rates for the entire respondents (N=3395) and for those with chronic conditions (N=777). Forty-three percent of the total subjects reported an ambulatory physician visit within the past three months. About 17% of subjects with one chronic condition and 14% of those with two or more chronic conditions did not have any physician visits within recent three months. The regression model demonstrated that having a home doctor, as well as comorbidity and perceived health status, is significantly associated with outpatient visit both among all subjects (p < 0.0001) and among those with chronic conditions (p < 0.01). The Japanese health system still has unevenness in outpatient resource utilization. This mainly pertains to whether they have their own regular physician. The failure of some persons with chronic diseases to be seen requires further investigation.

[Meningococcemia associated with C7 deficiency].

We report a 20-year-old woman who developed meningococcemia. The patient developed fever, vomiting and skin rash, then was sent to our hospital for shock. Physical and laboratory examination revealed septic shock and DIC. Her blood culture grew Neisseria meningitidis (W135). She recovered promptly with PCG, gabexate mesilate and intensive care for shock. Hemolytic activities of the patient's complement were less than 12/CH50 during the course. Screening for each component of the complements suggested that this patient had deficiency of C7. Meningococcal disease has seldom seen in Japan. Early recognition is essential so that appropriate antibiotic therapy and supportive care can be promptly started because shock and death may ensure within hours after onset of symptoms.

Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan.

Development of the Japanese SF-36 was completed in two phases: Phase 1: Japanese version 1.1 was produced according to International Quality of Life Assessment (IQOLA) project guidelines, but some results of psychometric tests were unexpected. First, scores varied little across physical-functioning items. Second, using factor analysis, we could not clearly distinguish the scales designed to measure the "physical" component of quality of life from those designed to measure the "mental" component. Phase 2: Focus-group discussions revealed that limited had often been interpreted as limited by a doctor. Therefore, is difficult to do was used instead (version 1.2). Results of two surveys indicated that version 1.2 yields scores that are reliable by internal consistency and test-retest standards and yields two principal components. In Japan, however, the pattern of correlations between some scales and the principal components differs from that in the United States. Iterative use of qualitative and quantitative methods was very important in developing the Japanese SF-36.

[Validation of interviewer administration of the Short Form 36 Health Survey, and comparisons of health-related quality of life between community-dwelling and institutionalized elderly people].

The Short Form 36 Health Survey (SF-36) is a questionnaire that is widely used to measure health-related quality of life. Because self-administered questionnaires may not be appropriate for seriously ill or elderly people, we administered the SF-36 to institutionalized elderly people by face-to-face interviews, and tested its reliability and validity. We also compared the SF 36 score of those subjects with the scores of community-dwelling elderly people. We studied 117 people aged 65 or over who were living in residential facilities on Sado island and 62 randomly sampled elderly people who were living in the community. The SF-36 scores of the institutionalized subjects had acceptable ceiling and floor effects, and their internal consistency, concurrent validity, and construct validity were high. The only exceptions were the scores of the "vitality" subscale. Adjusted mean scores on four subscales were higher among the institutionalized subjects than among those living in the community: role limitation due to physical condition, role limitation due to emotional condition, social functioning, and bodily pain. The two groups did not differ with regard to scores on the "mental health" scale, the "vitality" scale, or the "general health perception" scale. We conclude that the SF-36 can be useful for measuring health-related quality of life among institutionalized elderly people, if it is administered in face-to-face interviews.

[Detection of neural crest tumors by 123I-MIBG scintigraphy].

From January 1993 to January 1994, scintigraphy with 123I-MIBG and/or 131I-MIBG were performed in 22 patients and their scintigraphic usefulness was evaluated. Iodine-123 MIBG and 131I-MIBG scintigrams were obtained 24 hours after injection of 222 MBq of 123I-MIBG and 48 hours after injection of 20 MBq of 131I-MIBG, respectively. In two patients with pheochromocytoma, the 123I-MIBG and 131I-MIBG scans were performed and both images were compared. In a patient with single intraadrenal pheochromocytoma, the lesion not detected with 131I-MIBG was clearly visualized with 123I-MIBG. In the other patient with multiple metastatic pheochromocytoma, much more lesions were distinctly demonstrated on the 123I-MIBG images than on the 131I-MIBG images. All of the lesions were detected with 123I-MIBG in a patient with pheochromocytoma, 3 patients with neuroblastoma and a patient with medullary thyroid cancer. Most of the normal adrenal glands (86%) were visualized on the 123I-MIBG scintigrams, in 7 patients without neural crest tumor and adrenal diseases, while 131I-MIBG scintigraphy failed to visualize normal adrenal glands in 2 hypertensive patients. The main reason for the superiority of 123I-MIBG to 131I-MIBG is considered to be as follows: 1) higher specific activity of 123I-MIBG. 2) the larger amount of 123I-MIBG used. 3) gamma ray energy of 123I is ideal for gamma camera. In conclusion, 123I-MIBG appears to be a more suitable imaging agent than 131I-MIBG in depicting neural crest tumors.

Clinical usefulness of a highly sensitive enzyme-immunoassay of TSH.

Using a recently developed sensitive enzyme immunoassay (EIA) for TSH, serum TSH levels in normal subjects and patients with various thyroid disorders were measured. The minimum detectable concentration was less than 0.005 mU/l. An excellent correlation was observed between TSH values measured by EIA and by sensitive radioimmunoassay (r = 0.932). In 26 normal subjects, serum TSH ranged from 0.30 to 2.65 mU/l (geometric mean 0.97 mU/l). In 27 untreated hyperthyroid Graves' patients, serum TSH was detected in all but one, ranging from 0.005 to 0.19 mU/l (geometric mean 0.040). These values were proved to be specific for human TSH by absorption, recovery, cross-reactivity and dilution studies; non-specific serum effects were also ruled out. In 10 patients with destructive thyroiditis, similar TSH values (0.005-0.20 mU/l, mean 0.032) were observed. However, no significant correlations between TSH and circulating thyroid hormone levels were observed in these thyrotoxic conditions. Furthermore, 9 untreated Graves' patients did not respond to a single i.v. injection of TRH. In 13 hypothyroid patients with hypothalamo-pituitary disorders, 10 had basal TSH levels of less than 0.4 mU/l, and TRH tests in five gave peak TSH values of more than 0.8 mU/l, which were associated with significant increases in serum T3. In three patients with Sheehan's syndrome, elevated basal TSH levels were observed. Two of them responded to TRH, but these TSH elevations were not associated with T3 increases. In conclusion, this sensitive EIA could measure TSH levels in most patients with thyrotoxicosis and central hypothyroidism. However, the true significance of these measured values needs to be elucidated by future studies.

[Clinical evaluation of routinely applied highly sensitive TSH-RIA].

Forty-one routine TSH assays were carried out by applying newly developed, highly sensitive TSH RIA (T. Mori, et al., Folia Endocrinol. Jap., 56: 1231, 1980). B/B0 percent of the least standard point (0.156 microU/ml) was consistently lower than B0 and higher than that of 0.31 microU/ml. The distributions of assayed TSH concentrations in 1394 sera revealed that 34.8% of the total were in an undetectable range when measured by conventional method (less than 1.0 microU/ml), but this method picked up 16.4% (0.156-1.0 microU/ml), and only 5.4% exceeded the upper limit (20 microU/ml). TRH test results (500 micrograms i.v. bolus) in 45 cases of thyroid disorders with low or normal basal TSH revealed that the peak TSH of those with basal TSH of 0.156-1.0 microU/ml (8.98 +/- 4.15 microU/ml) was significantly different from those of less than 0.156 microU/ml or 1.0-3.2 microU/ml. Further, TSH concentrations in 19 patients after T3 administration (75 micrograms X 7 days) were 0.183 +/- 0.073 microU/ml, and all but one (0.43 microU/ml) showed values lower than the normal range (0.31-3.2 microU/ml). Thyroid hormone concentrations in cases with TSH of 0.156-1.0 microU/ml were limited in the ranges of less than 300 ng/dl T3 and/or less than 15 micrograms/dl T4, and these were considered to be the threshold of definite TSH inhibition.(ABSTRACT TRUNCATED AT 250 WORDS)

[The development of a sensitive radioimmunoassay for H-TSH and its clinical application (author's transl)].

Using a commercially available h-TSH RIA kit (Daiichi), a sensitive RIA method was developed. When pooled serum from patients with active Graves' disease was used as a carrier, combined applications of a delayed addition of 125-I TSH and utilization of X2 diluted anti-TSH antibody resulted in the consistent detection of 0.156 microunits/ml level of serum TSH. Further, 0.078 microunits/ml level could also be detected when 200 microliter of serum samples were applied. However, usage of 200 microliter sample volume should be determined after further studies concerning possible non specific effects of human serum. Assay results of 29 patient sera by the sensitive assay correlated quite well (r = 0.953, Y = 0.97X-0.06) with those by the regular assay. Serum TSH in all of the 20 normal subjects were detectable and ranged from 0.31 to 3.2 microunits/ml giving mean values of 1.48 +/- 0.65 (s.d.) microunits/ml. Values less than 0.156 microunits/ml were observed in patients with untreated Graves' disease, acute stage of subacute thyroiditis, and panhypopituitarism, and in postoperative cancer patients under suppressive doses of T-4. In conclusion, this sensitive TSH RIA made clear discrimination of low and normal serum TSH possible, and the clinical application of this method was considered quite useful.