Standards for implementation of neonatal screening and informed consent

わが国における新生児マス・スクリーニングについて，新規プログラムの導入条件，あるいは既存プログラムの再評価の基準について，その評価枠組みの検討を行った。また，その際，スクリーニングを実施する上でのインフォームド・コンセントの条件についても併せて検討を行った。実施条件については，系統的なWilsonらの指針および米国特別委員会の最良根拠の評価基準を参照して，評価枠組みを設定した。また，インフォームド・コンセントとしては，日常臨床での一般的な内容と条件が，スクリーニングにおいても適用されることを認識し，患者基準に基づき，医療行為の内容，危険と利益，選択性に関する情報の提供が必要であることが指摘された

Helicobacter pylori カンセン ノ シンダン ケンサ ノ ユウコウセイ ト ヒヨウ

Objective : To evaluate and compare efficacy, costs and efficiency of three diagnostic tests for Helicobacter pylori (H.pylori) infection among patients with peptic ulcer and dyspepsia patients. Methods : All English and Japanese articles from 1988 to 1999 about diagnostic tests for H.pylori were identified by MEDLINE (for English) and JAPICDOC (for Japanese) search. They are complemented by manual search. As diagnostic tests, invasive (culture and histological detection) and non-invasive (13C-UBT) tests were used. Meta-analysis of sensitivity, specificity and accuracy of tests was done. Costs were identified and caluculated from reimbursement rate in the National Health Insurance. Cost-effectiveness analysis from a perspective of the third party payer was done to evaluate efficiency of these tests. Sensitivity analysis was carried out to examine the stability of the results of economic evaluation. Results : While 13C-UBT had the highest sensitivity (97%), culture test had the highest specificity (100%). Accuracy was the highest in 13C-UBT (96%). Direct costs were the lowest in 13C-UBT ($112). Cost-effectiveness analysis showed that 13C-UBT was dominant among these tests. Sensitivity analysis of test sensitivity, costs and prevalence confirmed these results. Conclusion : These results suggest that 13C-UBT is an effective and efficient diagnostic test for H.pylori infection. 13C-UBT may warrant wide utilization. Since there are several limitations in this study, further research should be done to confirm this study

Needs assessment for healthcare technology assessment in Japan

Objective: Healthcare technology assessment (HTA) plays an essential role to support decision making in both health policy and clinical practice. To identify needs for HTA among general practitionners in Japan, a questionnaire survey carried out. Methods: A questionnaire survey was carried out. The subjects were 42 members of a association of general practitionner at Osaka in Japan. The valid response (rate) was 33 (79%). A questionnaire consisted of two parts. The first part dealt with needs and benefits for HTA. The second part dealt with prioritization of HTA. Results: A proportion of respondents who strongly pointed out the need of assessment for clinical effectiveness, efficiency, and ethical problems was 69%, 38%, and 63%, respectively. The most frequently suggested organizations for HTA was medical and dental associations (27%). A high priority was given to medical procedures as a type of healthcare technologies (HTs). Frequently mentioned HTs for HTA were as follows ; gene therapy, cancer chemotherapy, organ tansplantation, cancer screening, minimally invasive therapy, emergency medicine and so on. Conclusion : Most general pracititionners in an associations in Osaka, Japan have great concerns for needs of HTA. HTs identified as candidates for HTA were gene therapy, cancer chemotherapy, organ tansplantation and so on. On the basis of these results, further evaluations and discussions on priority settings for HTA should be done

シンゾウ イショク ノ ベンエキ : シハライ イシ ニヨル ヒョウカ

Objective : Since heart transplantation (HT) is expensive high medical technology, its benefitsand costs should be examined for appropriate utilization. In Japan, this issue has becomemore and more controversial. To estimate benefits of HT, economic evaluation usingwillingness to pay (WTP) carried out.Subjects and methods : Subjects were 85 medical students in Japan. An interview surveywas carried out to estimate the value of HT. Contingent valuation using WTP was done tovalue HT in monetary terms. As WTP, direct method (open-ended questions) and biddinggames were used. Household income among the subjects and improvement of quality of lifeby HT were assessed. As scope tests, correlation between them and WTP was examined.The valid response (rate) was 85 (100). The average age (standard deviation) was 22.4 (2.5).The proportion of men was 59%.Results : The average (standard deviation) WTP for HT by direct and bidding game methodswere $45,200 (38900) and$46,700 (44400), respectively. They were higher than costs of HTreported in the published papers. There was no statistical significance in correlation betweenWTP and income. However, statistically significant correlation was observed between WTPand improvement of quality of life by HT.Conclusion : This study shows that WTP is applicable to evaluate benefits of HT in monetaryterms. WTP was higher than costs of HT reported. These results indicate that HT iscost-benefit. Based on this study, further research among patients with heart diseases andthe general population should be done for healthcare policy decision

Description and valuation of health-related quality of life among the general public in Japan by the EuroQol

Objective. Health-related quality of life plays an important role in assessing the effectiveness of health care. The EuroQol is a generic instrument for describing and valuing health-related quality of life. To elicit health state descriptions and their preferences among the general public in Japan and compare them with cross-national data, a feasibility study for applying the EuroQol to the general public in Japan was carried out. Subjects and methods. The subjects were 120 people aged 40s-60s randomly selected in a suburban area at Aichi Prefecture in Japan. In assessing health states and their preferences, the EuroQol valuation instrument (version 12, 1991) translated into Japanese was used. The questionnaires were distributed and collected by public health nurses. The valid responses (rate) were 89 (74%). Results. The mean scores (raw scores) using the visual analogue scale (VAS) for one’s own health was 89.2. No statistically significant difference in VAS scores was observed for both sex and age. The contribution ratio of own health status, sex and age was 0.326 (p<0.0001). The main independent variables were three dimensions of health status.Valuations for core health states varied from 96.3 (no problems in each health status) to 6.8 (dead). These VAS scores in Japan were correlated with those from other countries (p<0.001). A multivariate analysis indicated that bias from own health status on preference valuations for core health states was not observed. Conclusion. The health states and their preferences among the general public in Japan were estimated by using the EuroQol. The results show the feasibility of evaluation for health states quantitatively. Moreover, this study suggested cross-national and cross-cultural applicability of the EuroQol

Development of the Japanese 15D Instrument of Health-Related Quality of Life: Verification of Reliability and Validity among Elderly People

<div><p>Objective</p><p>The 15D is a self-administered questionnaire for assessment of health-related quality of life, which contains 15 questions with 5 response options each. This study was conducted to evaluate the reliability and validity of the Japanese 15D.</p> <p>Methods</p><p>The subjects were 430 community-dwelling elderly people. Each item of the 15D was scored on a 5-point Likert scale, with level 1 being the best, score 1. Reliability was assessed by determination of the internal consistency and test-retest reliability. Criterion-based validity was assessed using the Japanese version of the Nottingham Health Profile (NHP) and Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG index). Acceptability was assessed by inquiring about the time required to complete the questionnaire and the burden felt in responding to it.</p> <p>Results</p><p>The answers of 423 individuals who responded to all items were analyzed. The median time required to complete the questionnaire was 5.0 minutes, and the proportion of subjects who indicated that the questionnaire was easy to complete was 98.3%. The Cronbach’s alpha coefficients for all 15 items in the 2 surveys were 0.793 and 0.792, respectively. The intraclass correlation coefficients for the 15 items ranged from 0.44 to 0.72. In the relationship between the 15D and the NHP, the correlation coefficients between the corresponding domains were higher than those between non-corresponding domains. The prevalence of disability in higher-level functional capacity was higher in the “level 2 to 5” group than in the “level 1” group.</p> <p>Conclusions</p><p>The Japanese version of the 15D showed sufficient internal consistency and moderate repeatability. Because of the short time required to complete the Japanese 15D and the significant relationships between the scores on the 15D and the NHP, and between the 15D and higher-level functional capacity, the acceptability and validity of the Japanese 15D were considered to be sufficient.</p> </div

Demographic characteristics of the subjects (N = 423).

<p>Demographic characteristics of the subjects (N = 423).</p