[Effectiveness of COVID-19 mRNA vaccine against hospitalization during the alpha and delta variant surges in Tokyo].

Objective　Evidence on COVID-19 vaccine effectiveness outside of clinical trials is insufficient. We aimed to determine the real-world effectiveness of mRNA vaccines in preventing hospitalization via data from the Health Center Real-time Information-sharing System on COVID-19 (HER-SYS), a national public database on COVID-19 cases in Japan.Methods　This case-control study targeted residents of Minato-ward, Tokyo, aged ≥50 years, who were COVID-19 positive between May 17 and Sep 30, 2021 (the alpha and delta strains-dominant period). Those hospitalized within 10 days of onset or diagnosis were considered the case group and control patients were not hospitalized. Patients were grouped according to vaccination status; group 1, unvaccinated, groups 2 and 3, who received the first dose ≤14 days and ≥15 days, respectively, and groups 4 and 5, who received the second dose ≤14 and ≥15 days before onset, respectively. To estimate vaccine effectiveness, adjusted odd ratios (OR) were calculated for each group against group 1. Furthermore, to determine other risk factors for hospitalization, OR were calculated for age, sex, and presence of any underlying diseases.Results　This study analyzed 192 case and 366 control patients. The adjusted OR were 1.48 (95% Cl=0.88-2.50), 0.71 (95% Cl=0.27-1.80), 0.58 (95% Cl=0.20-1.66), and 0.30 (95% Cl=0.13-0.67) for groups 2-5, respectively. Additionally, the adjusted OR were 1.57 (95% Cl=1.07-2.29), 1.05 (95% Cl=1.03-1.07), and 1.69 (95% Cl=1.15-2.48) for presence of underlying disease, 1-year increase of age, and men, respectively.Conclusion　Patients aged ≥50 years who received the second dose of the mRNA vaccine ≥15 days before onset had a significantly lower risk of hospitalization. Additionally, older age, men, and presence of underlying diseases were risk factors for hospitalization. Further studies on vaccine effectiveness to prevent severe diseases, hospitalization, and death following booster immunization during the omicron strain-dominant period are warranted.

Calcium Intake Contributed by Whole Foods and Gastric Cancer in Viet Nam: A Case­Control Study.

BACKGROUND: Recent studies revealed the potential tumor-suppressive effects of calcium. We aimed to investigate the association between dietary calcium intake contributed by whole foods and gastric cancer. METHODS: 466 gastric cancer cases and 1531 controls were extracted from the completed case-control studies in hospitals in Hanoi from 2017 to 2019. A validated semi-quantitative food frequency questionnaire was used to obtain data via face-to-face interviews with the trained interviewer. Calcium intake was calculated based on the food frequency intake per year. Adjusted odds ratios (OR) and 95% confidence intervals (95% CI) were calculated. RESULTS: The study participants consumed less than 50% of 700 mg/day compared to the recommended calcium intake. With increasing calcium intake, we found a reduction in gastric cancer in both genders, men and women (adjusted OR and 95%CI, 5th vs. 1st quintile: 0.50 (0.36, 0.70), p_trend 0.000; 0.62 (0.42, 0.92), p_trend 0.019; and 0.30 (0.16, 0.57), p_trend 0.000, respectively). The inverse association remained in the subgroups of never-smokers and those with positive H. pylori infection. CONCLUSION: We observed substantial benefits of calcium intake from whole foods against gastric cancer in the Vietnamese population with a low nutritious status.

A prospective cohort study on the association between waterpipe tobacco smoking and gastric cancer mortality in Northern Vietnam.

Tobacco consumption, as a worldwide problem, is a risk factor for several types of cancer. In Vietnam, tobacco consumption in the form of waterpipe tobacco smoking is common. This prospective cohort study aimed to study the association between waterpipe tobacco smoking and gastric cancer mortality in Northern Vietnam. A total of 25,619 eligible participants were followed up between 2008 and 2019. Waterpipe tobacco and cigarette smoking data were collected; semi-quantitative food frequency and lifestyle questionnaires were also utilized. Gastric cancer mortality was determined via medical records available at the state health facilities. A Cox proportional hazards model was used to estimate hazard ratios (HR) and 95% confidence intervals (95% CI). During 314,992.8 person-years of follow-up, 55 men and 25 women deaths due to gastric cancer were identified. With never-smokers as the reference, the risk of gastric cancer mortality was significantly increased in participants who were ever-smoking (HR = 2.43, 95% CI = 1.35-4.36). The positive risk was also observed in men but was not significantly increased in women. By types of tobacco use, exclusive waterpipe smokers showed a significantly increased risk of gastric cancer mortality (HR = 3.22, 95% CI = 1.67-6.21) but that was not significantly increased in exclusive cigarette smokers (HR = 1.90, 95% CI = 0.88-4.07). There was a significant positive association between tobacco smoking and gastric cancer death for indicators of longer smoking duration, higher frequency per day, and cumulative frequency of both waterpipe and cigarette smoking. Waterpipe tobacco smoking would significantly increase the risk of gastric cancer mortality in the Vietnamese population. Further studies are required to understand the waterpipe tobacco smoking-driven gastric cancer burden and promote necessary interventions.

Cost-effectiveness analysis of lemborexant for treating insomnia in Japan: a model-based projection, incorporating the risk of falls, motor vehicle collisions, and workplace accidents.

BACKGROUND: Lemborexant has demonstrated statistically significant improvements in sleep onset and sleep maintenance compared with placebo and zolpidem tartrate extended release, measured both objectively using polysomnography and subjectively using sleep diaries, in the phase 3 clinical trial SUNRISE 1. This study evaluated the cost-effectiveness of lemborexant compared with suvorexant, zolpidem immediate release (IR), and untreated insomnia. METHODS: A decision-tree model was developed for falls, motor vehicle collisions, and workplace accidents associated with insomnia and insomnia treatments from a Japanese healthcare perspective and with a 6-month time horizon. The model extracted subjective sleep onset latency treatment responses and disutility values for non-responders from SUNRISE 1. Cost-effectiveness was assessed using incremental cost per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were conducted to evaluate the impact of parameter uncertainty on the results. RESULTS: In the base-case analysis, the mean estimated QALYs for lemborexant, suvorexant, zolpidem-IR, and untreated insomnia were 0.4220, 0.4204, 0.4113, and 0.4163, and expected medical costs were JPY 34 034, JPY 38 371, JPY 38 139, and JPY 15 383, respectively. Lemborexant saved JPY 4337 and JPY 4105 compared with suvorexant or zolpidem-IR, respectively, while conferring QALY benefits. The incremental cost-effectiveness ratio (ICER) of lemborexant compared with that of untreated insomnia was JPY 3 220 975 /QALY. Lemborexant was dominant over suvorexant and zolpidem-IR and was cost-effective when compared with untreated insomnia. Sensitivity analyses supported the results' robustness. CONCLUSIONS: In a Japanese clinical practice setting, lemborexant may represent a better investment for treating insomnia in the healthcare system in Japan.

Signal Detection of Acute Renal Failure Following the Use of SGLT-2 Inhibitors: Stratified Analysis and Time Trend Analysis in Japan and the United States.

The results of previous studies that have used databases to investigate the associations between sodium-glucose-cotransporter-2 (SGLT-2) inhibitors and acute renal failure (ARF) have differed, and the impact of biases such as the Weber effect and stimulated reporting has not been fully examined. This study aimed to determine the associations between SGLT-2 inhibitors and ARF using signal detection, the effects on signals of regulatory agency alerts for ARF, and the publication of prominent studies by measuring changes in signals over time. Data registered in the Food and Drug Administration's Adverse Event Reporting System from January 2013 to March 2020 were downloaded, signals were detected, and reporting odds ratios (RORs) were calculated for each country of occurrence (Japan/the United States). Quarterly changes in the number of reports and RORs were examined. Although an association between SGLT-2 inhibitor use and ARF was suggested in the United States, this study did not suggest such an association in Japan. The number of reports and RORs fluctuated when regulatory alerts and prominent studies were published, and events affecting the number of reports and RORs varied by country. This study revealed the difference in the associations between SGLT-2i and ARF in Japan and the United States. Additionally, the signal was identified to be influenced by alerts and the publication of studies. Therefore, these results should be interpreted cautiously as there could be a possibility of overestimation due to alert biases and publication of studies.

Improvement in prescriptions while maintaining overall health outcomes: a prospective observational study conducted in Japanese facilities for older people.

BACKGROUND: Improvements in the use of polypharmacy or potentially inappropriate medication (PIM) may reduce medication costs in Japan. We aimed to evaluate the impact of improvement in prescription on both overall health outcomes and medication costs in Japanese facilities for older people. METHODS: Residents in Japanese facilities for older people between March 2019 and March 2020 were included in this study. The following five indices were used to evaluate overall health outcomes: EuroQoL-5D-5L, Barthel Index, Mini Mental State Examination, Dementia Behaviour Disturbance Scale, and Vitality Index. The team, which consisted of one physician and several pharmacists, suggested improved prescriptions for the attending physicians of the participants. The impact of improvement in prescriptions on the health outcomes score, medication costs, and the number of medications were evaluated through two comparison groups: those whose number of medications decreased (decrement group, DG) and those whose medications did not (not decrement group, NDG); those prescribed PIMs in March 2019 and those not prescribed PIMs in March 2020 (improvement group, IG) and those prescribed PIMs both in March 2019 and March 2020 (not improvement group, NIG). In both comparison groups, propensity score matching was performed to balance demographics, and all health outcome scores, medication costs, and the number of medications in March 2020 were assessed using a t-test. Statistical significance was set at a p-value of < 0.05. RESULTS: Eight-hundred-and-ninety-one participants (75.5% women, 86.2 ± 7.9 years old) were enrolled. After matching, in the comparison between the DG (N = 232, 77.2%, 85.7 ± 8.5) and NDG (N = 232, 78.5%, 86.0 ± 3.1), changes in the health outcomes score were nonsignificant. However, the medication costs and the number of medications significantly decreased. After matching, in the comparison between IG (N = 141, 75.2%, 86.7 ± 8.1) and NIG (N = 273, 74.2%, 86.2 ± 8.3), changes in health outcome scores and medication costs were not significant. However, the number of medications significantly decreased. CONCLUSIONS: Improvements in prescriptions did not adversely affect the overall health outcomes. However, it impacted medication costs and the number of medications. Improvement in prescriptions could decrease medication costs while maintaining overall health outcomes.

Occupation- and industry-specific cancer mortality among Japanese women from 1980 to 2015.

BACKGROUND: The number of women in Japan who continue working after childbirth is on the rise. Over the past few years, Japan's cancer mortality rate has increased. About 50% of all cancer deaths among Japanese women aged 25-64 are caused by lung, gastric, pancreatic and colorectal cancers. This study aims to examine the difference in mortality risk for key cancers among women and explore the effect of the economic crisis in the mid-1990s separately for occupational and industrial categories. METHODS: Data from 1980 to 2015 were gathered from the Japanese Population Census and National Vital Statistics conducted in the same year. A Poisson regression analysis was used to estimate mortality risk and mortality trends for lung, gastric, pancreatic and colorectal cancer among Japanese working women aged 25-64 years. RESULTS: Across most industrial and occupational groups, the trends in age-standardised cancer mortality rate for women have declined. Workers in management, security and transportation have a higher cancer mortality risk than sales workers. The risk of death from all four cancers is higher for workers in the mining and electricity industries than for wholesale and retail workers. CONCLUSION: To improve the health and well-being of employed Japanese women, it is crucial to monitor cancer mortality trends. Using these population-level quantitative risk estimates, industry- and occupation-specific prevention programmes can be developed to target women at higher cancer risk and enable the early detection and treatment of cancer.

Mapping naso-ocular symptom scores to EQ-5D-5L utility values in Japanese cedar pollinosis.

BACKGROUND: The total naso-ocular symptom score (TSS) is widely used as an endpoint to evaluate the severity of seasonal allergic rhinitis. However, it is not a generic preference-based measure. We sought to develop an algorithm for mapping between the TSS and health utility in Japanese cedar pollinosis (JCP). We also performed a cost-utility analysis of sublingual immunotherapy (SLIT) for JCP by using this algorithm. METHODS: Patients with JCP filled out the TSS questionnaire and EQ-5D-5L simultaneously during the pollen season in 2019 and in 2020. We estimated a direct utility mapping model by regressing responses to individual TSS questions directly onto utility. The incremental cost-effectiveness ratio (ICER) of active SLIT to a placebo was determined by examining the drug expense and the estimated quality-adjusted life year (QALY) using a dataset from a double-blind placebo-controlled clinical trial. RESULTS: A total of 238 records were included for analysis. The estimated utility decreased with increasing severity of rhinitis. Patients with comorbid asthma showed lower utility. A negative and significant correlation was seen between the TSS and utility in both 2019 and 2020. The estimated equations were: Y(utility) = -0.0161∗X(TSS) + 1.005 in non-asthmatic JCP patients. The ICER of active SLIT to the placebo was estimated to be 4,049,720 and 6,011,218 JPY/QALY in the first and second year, respectively. CONCLUSIONS: It is possible to reasonably predict utility from the total naso-ocular symptom score by using regression models. In the estimated algorithm, pre-seasonal SLIT for JCP is cost-effective.

Malaria rapid diagnostic test (HRP2/pLDH) positivity, incidence, care accessibility and impact of community WASH Action programme in DR Congo: mixed method study involving 625 households.

BACKGROUND: Malaria is one of the most prevalent and deadliest illnesses in sub-Saharan Africa. Despite recent gains made towards its control, many African countries still have endemic malaria transmission. This study aimed to assess malaria burden at household level in Kongo central province, Democratic Republic of Congo (DRC), and the impact of community participatory Water, Sanitation and Hygiene (WASH) Action programme. METHODS: Mixed method research was conducted in two semi-rural towns, Mbanza-Ngungu (a WASH action site) and Kasangulu (a WASH control site) in DRC between 1 January 2017 through March 2018, involving 625 households (3,712 household members). Baseline and post-intervention malaria surveys were conducted with the use of World Bank/WHO Malaria Indicator Questionnaire. An action research consisting of a six-month study was carried out which comprised two interventions: a community participatory WASH action programme aiming at eliminating mosquito breeding areas in the residential environment and a community anti-malaria education campaign. The latter was implemented at both study sites. In addition, baseline and post-intervention malaria rapid diagnostic test (RDT) was performed among the respondents. Furthermore, a six-month hospital-based epidemiological study was conducted at selected referral hospitals at each site from 1 January through June 2017 to determine malaria trend. RESULTS: Long-lasting insecticide-treated net (LLIN) was the most commonly used preventive measure (55%); 24% of households did not use any measures. Baseline malaria survey showed that 96% of respondents (heads of households) reported at least one episode occurring in the previous six months; of them only 66.5% received malaria care at a health setting. In the Action Research, mean incident household malaria cases decreased significantly at WASH action site (2.3 ± 2.2 cases vs. 1.2 ± 0.7 cases, respectively; p < 0.05), whereas it remained unchanged at the Control site. Similar findings were observed with RDT results. Data collected from referral hospitals showed high malaria incidence rate, 67.4%. Low household income (ORa = 2.37; 95%CI: 1.05-3.12; p < 0.05), proximity to high risk area for malaria (ORa = 5.13; 95%CI: 2-29-8.07; p < 0.001), poor WASH (ORa = 4.10; 95%CI: 2.11-7.08; p < 0.001) were predictors of household malaria. CONCLUSION: This research showed high prevalence of positive malaria RDT among the responders and high household malaria incidence, which were reduced by a 6-month WASH intervention. DRC government should scale up malaria control strategy by integrating efficient indoor and outdoor preventive measures and improve malaria care accessibility.

Synthesis of 1-(1-Arylvinyl)pyridin-2(1H)-ones from Ketones and 2-Fluoropyridine.

We describe a simple and efficient procedure for the synthesis of N-vinyl-substituted pyridones from ketones and 2-fluoropyridine in the presence of trifluoromethane sulfonic anhydride, followed by a base treatment. Various ketones with electron-donating or electron-withdrawing groups at the benzene rings can be used in this reaction. A preliminary mechanistic study indicates that it is not very likely that both vinyl triflates and vinyl cations play major roles as intermediates in this transformation.

Mortality due to HIV/AIDS in Viet Nam: time trend and related socio-economic status in some populations and periods from 2005 to 2014.

The study examined mortality due to HIV/AIDS and its time trend and ecological variables of socio-economic status during 2005-2014. Mortality data were obtained from the database of population-based mortality registration. Five variables including name, age, sex, date of death, and cause of death were collected from 10,184 of 10,769 local state health centers. Mortality rates ratio and 95% confidence interval (MRR, 95%CI) were calculated to observe the risk of death from HIV/AIDS-related to socio-economic status and time trends. The age-adjusted HIV/AIDS mortality rate increased from 5.49 per 100,000 during 2005 to 6.03 during 2006 and 6.20 during 2007. An elevated risk of death was seen in high mountain districts in Nghe An province, adjusted MRR = 5.38, 95%, CI: 4.76-6.08 relative to the urban areas of Vinh and Cua Lo cities. The highest age-adjusted mortality rate (147.1 per 100,000) was observed in a commune located in Thai Nguyen province. There was a statically significant decrease in HIV/AIDS mortality in Nghe An province from 2005-2006 to 2013-2014 (p < 0.05). The findings suggest that people living with HIV/AIDS in disadvantaged regions have a higher risk of death but there was a significant decrease in HIV/AIDS mortality in Nghe An province by 2013-2014.

Systematic literature review of clinical outcomes in adults with metastatic or advanced synovial sarcoma.

Background: Synovial sarcoma (SS) is a rare, aggressive soft tissue sarcoma with a poor prognosis after metastasis. The objective of this study was to conduct a systematic review of the clinical evidence for therapeutic options for adults with metastatic or advanced SS. Materials & methods: Relevant databases were searched with predefined keywords. Results: Thirty-nine publications reported clinical data for systemic treatment and other interventions. Data on survival outcomes varied but were generally poor (progression-free survival: 1.0-7.7 months; overall survival: 6.7-29.2 months) for adults with metastatic and advanced SS. A high frequency of neutropenia with systemic treatment and low quality of life post-progression were reported. Conclusion: Reported evidence suggests poor outcomes in adults with metastatic and advanced SS and the need for the development of new treatment modalities.

Dimensions of women's empowerment on access to skilled delivery services in Nepal.

BACKGROUND: Each day, approximately 810 women die during pregnancy and childbirth and 94% of the deaths take place in low and middle income countries. Only 45% of the births in South Asia are attended by skilled professionals, which is lower than that in other Asian regions. Antenatal and postnatal care received from skilled providers can help prevent maternal and neonatal mortality by identifying pregnancy-related complications. Women's empowerment is considered to be a significant determinant of maternal health care outcomes; however, studies on the contextual influences of different dimensions of empowerment in Nepal are relatively limited. Therefore, this study analyzed nationwide survey data to examine the influence of women's economic empowerment, sociocultural empowerment, familial/interpersonal empowerment and media and information technology empowerment on accessing skilled delivery services among the married women in Nepal. METHODS: This study examined the influence of women's empowerment on skilled delivery services among married women (n = 4400) aged 15-49 years using data from the 2016 Nepal Demographic and Health Survey. Descriptive analysis and binary logistic regression analysis were employed to analyze the data. RESULTS: Significant associations were found between women's media and information technology empowerment, economic empowerment and sociocultural empowerment and access to skilled birth attendants. Specifically, the education of women, their occupation, owning a bank account, media exposure, and internet use were significantly associated with the use of skilled birth attendants. CONCLUSION: Focusing on women's access to media and information technology, economic enhancement and education may increase the use of skilled birth attendants in Nepal.

Environmental and sociodemographic factors associated with household malaria burden in the Congo.

BACKGROUND: Malaria is one of the most severe public health issues that result in massive morbidity and mortality in most countries of the sub-Saharan Africa (SSA). This study aimed to determine the scope of household, accessibility to malaria care and factors associated with household malaria in the Democratic Republic of Congo (DRC). METHODS: This was a community-based cross-sectional study conducted in an urban and a rural sites in which 152 households participated, including 82 urban and 70 rural households (1029 members in total). The 'malaria indicator questionnaire' (MIQ) was anonymously answered by household heads (respondents), reporting on malaria status of household members in the last 12 months. RESULTS: There were 67.8% of households using insecticide-treated bed nets (ITN) only, 14.0% used indoor residual spraying (IRS) only, 7.3% used ordinary bed nets (without insecticide treatment), 1.4% used mosquito repelling cream, 2.2% combined ITN and IRS, whereas 7.3% of households did not employ any preventive measure; p < 0.01). In addition, 96.7% of households were affected by malaria (at least one malaria case), and malaria frequency per household was relatively high (mean: 4.5 ± 3.1 cases reported) in the last 12 months. The mean individual malaria care expenditure was relatively high (101.6 ± 10.6 USD) in the previous 12 months; however, the majority of households (74.5%) earned less than 50 USD monthly. In addition, of the responders who suffered from malaria, 24.1% did not have access to malaria care at a health setting. Furthermore, a multivariate analysis with adjustment for age, education level and occupation showed that household size (OR = 1.43 ± 0.13; 95% CI 1.18-1.73; p < 0.001), inappropriate water source (OR = 2.41 ± 0.18; 95% CI 1.17-2.96; p < 0.05) absence of periodic water, sanitation and hygiene (WASH) intervention in residential area (OR = 1.63 ± 1.15; 95% CI 1.10-2.54; p < 0.05), and rural residence (OR = 4.52 ± 2.47; 95% CI 1.54-13.21; p < 0.01) were associated with household malaria. CONCLUSION: This study showed that household size, income, WASH status and rural site were malaria-associated factors. Scaling up malaria prevention through improving WASH status in the residential environment may contribute to reducing the disease burden.

Mirabegron or tolterodine for the treatment of overactive bladder in Japan: Which drug is more cost-effective as the first-line treatment?

OBJECTIVES: To assess the cost-effectiveness of mirabegron 50 mg relative to tolterodine extended release 4 mg for the treatment of overactive bladder if used as the first-line treatment in Japan. METHODS: A Markov model was developed to simulate the cost-effectiveness of the mirabegron first-line treatment (and tolterodine second-line) versus tolterodine first-line treatment (and mirabegron second-line) taken for 5 years from the randomized European-Australian study (SCORPIO trial) and single technology appraisal assessment report by the National Institute for Health and Care Excellence. The incremental cost-effectiveness ratio was calculated with utility value by quality-adjusted life year with cost using the medical fee and the drug price tariff in 2016. For the study of transition of treatment status, our analytical model was established. The transition probabilities of severity states were calculated based on the probabilities for the mean numbers of incontinence episodes/day and micturition episodes/day in mirabegron-treated and tolterodine-treated patients in the single technology appraisal assessment report. RESULTS: The 5-year expected effect per patient was 3.860 quality-adjusted life years for first-line mirabegron and 3.839 quality-adjusted life years for first-line tolterodine. The 5-year expected cost per patient was ¥526 191 for first-line mirabegron, and ¥472 390 for first-line tolterodine. The incremental cost-effectiveness ratio was ¥2 565 927/quality-adjusted life year. This value was below the willingness-to-pay threshold of ¥5 million/quality-adjusted life year. In more severe states, the incremental cost-effectiveness ratio exceeded ¥5 million. CONCLUSIONS: First-line mirabegron appears to be more cost-effective than first-line tolterodine. In patients with severe symptoms, first-line mirabegron is not economically preferable.

Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan.

OBJECTIVES: In Japan, cost-effectiveness evaluation was implemented on a trial basis from fiscal year 2016. The results will be applied to the future repricing of drugs and medical devices. On the basis of a request from the Central Social Insurance Medical Council (Chuikyo), our research team drafted the official methodological guideline for trial implementation. Here, we report the process of developing and the contents of the official guideline for cost-effectiveness evaluation. METHODS: The guideline reflects discussions at the Chuikyo subcommittee (e.g., the role of quality-adjusted life-year) and incorporates our academic perspective. Team members generated research questions for each section of the guideline and discussions on these questions were carried out. A draft guideline was prepared and submitted to the Ministry of Health, Labour and Welfare (MHLW), and then to the subcommittee. The draft guideline was revised on the basis of the discussions at the subcommitte, if appropriate. RESULTS: Although the "public health care payer's perspective" is standard in this guideline, other perspectives can be applied as necessary depending on the objective of analysis. On the basis of the discussions at the subcommittee, quality-adjusted life-year will be used as the basic outcome. A discount rate of 2% per annum for costs and outcomes is recommended. The final guideline was officially approved by the Chuikyo general assembly in February 2016. CONCLUSIONS: This is the first officially approved guideline for the economic evaluation of drugs and medical devices in Japan. The guideline is expected to improve the quality and comparability of submitted cost-effectiveness data for decision making.

An exploration of differences between Japan and two European countries in the self-reporting and valuation of pain and discomfort on the EQ-5D.

PURPOSE: To investigate the systematic differences in the self-reporting and valuation of overall health and, in particular, pain/discomfort between three countries (England/UK, Japan, and Spain) on the EQ-5D. METHODS: Existing datasets were used to explore differences in responses on the EQ-5D descriptive system between Japan (3L and 5L), the UK (3L), England (5L), and Spain (5L), particularly on the dimension of pain/discomfort. The role of different EQ dimensions in determining self-reported overall health scores for the EuroQol visual analog scale (EQ-VAS) was investigated using ordinary least squares regression. Time trade-off (TTO) results from Japanese and UK respondents for the EQ-5D-3L as well as Japanese and English respondents for the EQ-5D-5L were compared using t tests. RESULTS: For the EQ-5D-3L, a higher percentage of respondents in Japan than in the UK reported 'no pain/discomfort' (81.6 vs 67.0%, respectively); for the EQ-5D-5L, the proportions were 79.2% in Spain, 73.2% in Japan, and 63-64% in England, after adjusting for age differences in samples. The 'pain/discomfort' dimension had the largest impact on respondents' self-reported EQ-VAS only for EQ-5D-3L in Japan. Using the EQ-5D-3L, Japanese respondents were considerably less willing to trade off time to avoid pain/discomfort than the UK respondents; for example, moving from health state, 11121 (some problems with pain/discomfort) to 11131 (extreme pain/discomfort) represented a decrement of 0.65 on the observed TTO value in the UK compared with 0.15 in Japan. Using the EQ-5D-5L, Japanese respondents were also less willing to trade off time to avoid pain/discomfort than respondents in England; however, the difference in values was much smaller than that observed using EQ-5D-3L data. CONCLUSIONS: This study provides evidence of between-country differences in the self-reporting and valuation of health, including pain/discomfort, when using EQ-5D in general population samples. The results suggest a need for caution when comparing or aggregating EQ-5D self-reported data in multi-country studies.

Comparison of Value Set Based on DCE and/or TTO Data: Scoring for EQ-5D-5L Health States in Japan.

BACKGROUND: The valuation study of the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) involved composite time trade-off (cTTO) and a discrete choice experiment (DCE). The DCE scores must be anchored to the quality-of-life scale from 0 (death) to 1 (full health). Nevertheless, the characteristics of the statistical methods used for converting the EQ-5D-5L DCE results by using TTO information are not yet clearly known. OBJECTIVES: To present the Japanese DCE value set of the EQ-5D-5L and compare three methods for converting latent DCE values. METHODS: The survey sampled the general population at five locations in Japan. 1098 respondents were stratified by age and sex. To obtain and compare the value sets of the EQ-5D-5L, the cTTO and DCE data were analyzed by a linear mixed model and conditional logit, respectively. The DCE scores were converted to the quality-of-life scale by anchoring to the worst state using cTTO, mapping DCE onto cTTO, and a hybrid model. RESULTS: The data from 1026 respondents were analyzed. All the coefficients in the cTTO and DCE value sets were consistent throughout all the analyses. Compared with the cTTO algorithm, the mapping and hybrid methods yielded very similar scoring coefficients. The hybrid model results, however, produced a lower root mean square error and fewer health states with errors exceeding 0.05 than did the other models. The DCE anchored to the worst state overestimated the cTTO scores of almost all the health states. CONCLUSIONS: Japanese value sets based on DCE were demonstrated. On comparing the observed cTTO scores, we found that the hybrid model was slightly superior to the simpler methods, including the TTO model.