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Development Of A Mortality Risk Prediction Tool For Patients With Heart Failure Or Chronic Kidney Disease At Risk Of Hyperkalaemia
A682
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
T-NOTECHS. Mean scores between two evaluators were 3.76 and 4.01, respectively. Chronbach’s alpha was 0.70 with inter-item correlation of 0.54. Intraclass correlation coefficient was 0.54 (95% CI, 0.34-0.70) and coefficient of repeatability was 1.53 (95% CI, 1.29-1.94). Conclusions: The T-NOTECHS instrument was successfully translated into Finnish. The Finnish version of the T-NOTECHS proved to have fair reliability. The Finnish T-NOTECHS can now be used to assess efficacy of trauma team performance in real-life resuscitations and in resuscitation simulation training. PHP174 Quantifying The Relationship Between Hyperkalaemia And Outcomes In Patients With Heart Failure Or Chronic Kidney Disease Bennett H1, Ayoubkhani D1, Evans M2, McEwan P1, Qin L3, Grandy S4, Palaka E5 1Health Economics and Outcomes Research Ltd, Cardiff, UK, 2University Hospital Llandough, Cardiff, UK, 3AstraZeneca, Gaithersburg, MD, USA, 4Astrazeneca Phamaceuticals , LP, Gaithersburg, MD, USA, 5AstraZeneca, Cambridge, UK
Objectives: Hyperkalaemia (HK) is associated with increased risk of mortality. Renin-angiotensin-aldosterone system inhibitors (RAASi) can reduce mortality risk and slow disease progression in heart failure (HF) and chronic kidney disease (CKD); however, their use may be limited by their potential to cause HK. This study aimed to quantify the relationship between elevated serum potassium (K+) levels and risk of mortality and RAASi discontinuation in HF and CKD. Methods: Poisson Generalized Estimating Equations, derived from time-updated serum K+ data in 23,541 HF and 144,388 CKD patients in Clinical Practice Research Datalink (01/01/2006–31/12/2015), were used to predict the incidence of all-cause mortality and RAASi discontinuation. Five-year event rates were estimated across a range of K+ levels, adjusting for demographics, comorbidities and concomitant medication. Results were reported for male (and female) CKD and HF patients of average age: 74 and 75 years, respectively. Results: Expected five-year mortality rates in CKD patients prescribed RAASi were 0.114, 0.116, and 0.142 (0.079, 0.080, and 0.098) for K+ levels of 4.5, 5.5 and 6.5 mEq/L, respectively; equivalent mortality rates for HF patients were 0.196, 0.210, and 0.316 (0.152, 0.164, and 0.246). RAASi discontinuation rates were 0.326, 0.419, and 0.576 (0.278, 0.358, and 0.492) in CKD and 0.407, 0.473, and 0.674 (both genders) in HF, for K+ levels of 4.5, 5.5 and 6.5 mEq/L, respectively. Discontinuing RAASi was associated with increased mortality risk: 0.263, 0.269, and 0.329 (0.182, 0.186, and 0.228) in CKD and 0.652, 0.701, 1.055 (0.508, 0.546, and 0.821) in HF, for K+ levels of 4.5, 5.5 and 6.5 mEq/L, respectively. Conclusions: Based on real-world UK data, this study highlights the strong association between elevated K+ levels and increased incidence of RAASi discontinuation and mortality. The risk outputs from this study are fit for use within long-term cost-effectiveness models assessing the benefits of effective K+ management in CKD and HF. PHP175 Willingness-To-Pay For Life-Saving Treatments In Thailand: A Discrete Choice Experiment Nimdet K1, Ngorsuraches S2 1Suratthani Provincial Public Health Office, Surat thani, Thailand, 2South Dakota State University, Brookings, SD, USA
Objectives: Many countries currently use cost-effectiveness threshold to guide their decisions on the selection of new healthcare technologies. However, individual’s willingness-to-pay (WTP) is essential to justify these decisions, especially for life-saving treatments since they tend to be more expensive. This study aimed to examine WTP for life-saving treatments. Methods: Dimensions and levels from EQ-5D-3L, and cost were used to develop a discrete choice experiment questionnaire. Each questionnaire was composed of five choice sets. Each choice set contained two alternatives with different levels across all dimensions and a reference alternative (death and cost= 0). Four hundred and eighty five respondents were conveniently sampled from three provinces in Thailand. They were asked to imagine that they had a life-threatening disease for one year. If they did not get any treatment, they would die. They could choose only one alternative in each choice set. A multinomial logit model using effect codes was developed and used to calculate the WTP of each level change for each attribute. The WTP for saving life and getting back to current health state was calculated. Results: A total of 459 respondents (approximately 94% of all sampled respondents) completed the questionnaire. The average utility score of their current health states was 0.826 + 0.170. Intuitively, the respondents preferred better health states. They were willingness to pay 161,000 Baht, 153,000 Baht, 126,000 Baht, 114,000 Baht, and 80,000 Baht for having no problem in pain/ discomfort, mobility, usual activities, self-care, and anxiety/depression, respectively. Their average WTP for saving life and getting back to current health state after having a treatment for one year was 1,250,000 Baht. Conclusions: Thai citizens might be willing to pay for life-saving treatments higher than the cost-effectiveness threshold (160,000 Baht per QALY) that the country guideline currently suggests. Policy makers can use this finding when they select life-saving treatments. PHP176 Development Of A Mortality Risk Prediction Tool For Patients With Heart Failure Or Chronic Kidney Disease At Risk Of Hyperkalaemia Bennett H1, McEwan P1, Ayoubkhani D1, Evans M2, Qin L3, Kim K4, Palaka E5 Economics and Outcomes Research Ltd, Cardiff, UK, 2University Hospital Llandough, Cardiff, UK, 3AstraZeneca, Gaithersburg, MD, USA, 4AstraZeneca, Södertälje, Sweden, 5AstraZeneca, Cambridge, UK
1Health
Objectives: Hyperkalaemia (HK) is associated with increased risk of mortality. This study aimed to develop a risk prediction tool to assess the probability of mortality in patients with heart failure (HF) or chronic kidney disease (CKD) at risk of HK, based on relevant demographics and clinical risk factors. Methods: Poisson Generalized Estimating Equations fitted to 23,541 HF and 144,388 CKD patients in Clinical Practice Research Datalink (Jan 2006–Dec 2015) were incorporated within an Excel-based tool to predict annual probabilities of mortality using demographic, comorbidity, concomitant medication and clinical measurement data. An illustration of the tool’s output is presented relative to a baseline probability for a male/
female with CKD/HF, non-smoker, aged 60, eGFR 50 ml/min/1.73m2, serum potassium (K+) 4.5 mEq/L, without diabetes or renin-angiotensin-aldosterone system inhibitor (RAASi) prescription. Results were expressed as percentage increase/ decrease from baseline. Results: The listed characteristics were all statistically significant predictors of mortality. Baseline annual mortaility probability was 0.016 and 0.068 in males and 0.008 and 0.055 in females, with CKD and HF, respectively. RAASi use was associated with decreased probability of death compared to baseline in CKD (56.6%) and HF (69.3%). Older age, increased K+, diabetes, smoking and reductions in eGFR all increased estimated probability of death. The influence of eGFR was greater for CKD patients (36.4%–153% for 10–30 ml/min/1.73m2 reduction) compared to HF (18.4%–65.2% for 10–30 ml/min/1.73m2 reduction). While the impact of K+ was greater for HF: 7.2% and 58.4% for K+ 5.5 and 6.5 mEqL, respectively, compared to 2.1% and 24.9% for CKD. Conclusions: Utilising real-world UK data, this evaluation of the impact of clinical risk factors on mortality risk in patients with CKD or HF serves as the structural framework for a broader tool to enhance the assessment of risk of outcomes in patients susceptible to HK. PHP177 The First EQ-5D-5L Value Set In Central And Eastern Europe Golicki D1, Jakubczyk M2, Graczyk K3, Niewada M1 of Clinical & Experimental Pharmacology, Medical University of Warsaw, Warsaw, Poland, 2SGH Warsaw School of Economics, Warsaw, Poland, 3HealthQuest, Warsaw, Poland 1Department
Objectives: There is no EQ-5D-5L value set for any Central and Eastern European country. Our objective was to derive a tariff for the EQ-5D-5L in Poland. Methods: Quota sampling was used to achieve a representative sample of the Polish population with regard to age, sex, education, geographical region, and the size of locality. The study design followed the EQ-VT protocol (v2.0). Fifteen trained professional interviewers performed computer-assisted face-to-face interviews between June and October 2016. Each respondent valued ten health states using composite time trade-off (cTTO) and completed seven discrete choice experiment (DCE) tasks. Quality control was performed according to EQ-VT rules. All the flagged interviews were removed. The hybrid model was estimated in Bayesian setting, with noninformative priors, using JAGS/R environment. Results: Data from 1252 respondents (52.5% females, age 18 - 91 years) were available. In the estimation, we used: 11,480 TTO valuations and 8,764 DCE pairs. In TTO, in 10.7% experiments, the time was not traded, and eight respondents did not trade for any state. The average utility of 55555 state in TTO amounted to -0.433. In the final model, the estimated decrease of utility for level five amounts to: 0.341 (Mobility), 0.312 (Self-Care), 0.237 (Usual Activities), 0.592 (Pain/Discomfort), and 0.249 (Anxiety/Depression). In the final value set we got u(22222) = 0.889, u(33333) = 0.832, u(44444) = 0.375, u(55555) = -0.731 (compare to u(33333) = -0.523 in the Polish EQ-5D-3L tariff). Conclusions: New value set is available and should be used in health technology assessment in Poland. It may be considered as a second best choice in other CEE countries, lacking their own directly measured or cross-walk value sets. The new tariff does not introduce revolutionary changes as compared to the previous EQ-5D-3L version but offers greater sensitivity to subtle health state changes thanks to five levels. PHP178 The Role Of Disability On Early Retirement Laires PA1, Gouveia M2, Canhão H3, Branco JC4 1Escola Nacional de Saúde Pública. Universidade NOVA de Lisboa, Lisbon, Portugal, 2Católica Lisbon School of Business and Economics, Lisbon, Portugal, 3Sociedade Portuguesa de Reumatologia, Lisboa, Portugal, 4Sociedade Portuguesa de Reumatologia, Lisbon, Portugal
Objectives: To examine the role of disability on early retirement in Portugal. Methods: We analyzed data from a nationwide epidemiological study performed between September 2011 and December 2013 (EpiReumaPt Study) consisting of a representative sample of the population with 10,661 surveyees. Data was self-reported and comprises sociodemographic and clinical variables (including major chronic diseases, such as cardiovascular, respiratory, gastrointestinal, mental disorders, neurological, rheumatic diseases and cancer). We analyzed those aged 50-64, near the official retirement age. Disability was measured according with the Health Assessment Questionnaire (HAQ). The association between disability and early retirement was estimated using multivariable logistic regression. Results: About 30% (29.9%) of the Portuguese population aged between 50 and 64 was retired and had a mean HAQ score of 0.33 (95% CI: 0.31-0.36). Women self-reported worse HAQ scores (mean: 0.45 versus men: 0.20, p< 0.001), while those with at least one major chronic disease were more likely to have higher mean HAQ scores (0.38 vs. 0.11, p< 0.001). Retirees presented worse disability compared with any other occupational status (mean HAQ average for retired: 0.44; unemployed: 0.34; and employed: 0.22). In fact, disability was significantly associated with early retirement (age- region- and sex-adjusted OR: 1.77; 95% CI: 1.39-2.27; p< 0.001), while the relationship between morbidity and this occupational outcome is only significant when disability is high (OR: 1.97; 95% CI: 1.44-2.70; p= NS). On the other hand, those with low disability are more likely to be employed regardless of their self-reported morbidity (OR: 1.94; 95% CI: 1.50-2.51; p< 0.001). Conclusions: Disability is an important intermediate step in the causal chain between morbidity and early retirement and should be addressed in policies aiming to reduce premature work withdrawal. HAQ assessment could be a relevant tool to be applied regularly in the workplace for those at risk of early retirement, namely sick employees near the statutory retirement age. PHP179 Reliability And Validity Of Two Proxy Versions Of EQ-5D-5L In Japan Noto S1, Igarashi A2, Shiroiwa T3, Fukuda T3, Ikeda S4, Moriwaki K5, Saito S6, Shimozuma K7, Ishida H8, Kobayashi M9 1Niigata University of Health and Welfare, Niigata, Japan, 2University of Tokyo, Tokyo, Japan, 3National Institute of Public Health, Wako, Japan, 4International University of Health and Welfare, Ohtawara, Japan, 5Kobe Pharmaceutical University, Kobe, Japan, 6Okayama University, Okayama, Japan, 7Ritsumeikan University, Kusatsu, Japan, 8Yamaguchi University Graduate School of Medicine, Ube, Japan, 9CRECON Medical Assessment Inc., Tokyo, Japan
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
T-NOTECHS. Mean scores between two evaluators were 3.76 and 4.01, respectively. Chronbach’s alpha was 0.70 with inter-item correlation of 0.54. Intraclass correlation coefficient was 0.54 (95% CI, 0.34-0.70) and coefficient of repeatability was 1.53 (95% CI, 1.29-1.94). Conclusions: The T-NOTECHS instrument was successfully translated into Finnish. The Finnish version of the T-NOTECHS proved to have fair reliability. The Finnish T-NOTECHS can now be used to assess efficacy of trauma team performance in real-life resuscitations and in resuscitation simulation training. PHP174 Quantifying The Relationship Between Hyperkalaemia And Outcomes In Patients With Heart Failure Or Chronic Kidney Disease Bennett H1, Ayoubkhani D1, Evans M2, McEwan P1, Qin L3, Grandy S4, Palaka E5 1Health Economics and Outcomes Research Ltd, Cardiff, UK, 2University Hospital Llandough, Cardiff, UK, 3AstraZeneca, Gaithersburg, MD, USA, 4Astrazeneca Phamaceuticals , LP, Gaithersburg, MD, USA, 5AstraZeneca, Cambridge, UK
Objectives: Hyperkalaemia (HK) is associated with increased risk of mortality. Renin-angiotensin-aldosterone system inhibitors (RAASi) can reduce mortality risk and slow disease progression in heart failure (HF) and chronic kidney disease (CKD); however, their use may be limited by their potential to cause HK. This study aimed to quantify the relationship between elevated serum potassium (K+) levels and risk of mortality and RAASi discontinuation in HF and CKD. Methods: Poisson Generalized Estimating Equations, derived from time-updated serum K+ data in 23,541 HF and 144,388 CKD patients in Clinical Practice Research Datalink (01/01/2006–31/12/2015), were used to predict the incidence of all-cause mortality and RAASi discontinuation. Five-year event rates were estimated across a range of K+ levels, adjusting for demographics, comorbidities and concomitant medication. Results were reported for male (and female) CKD and HF patients of average age: 74 and 75 years, respectively. Results: Expected five-year mortality rates in CKD patients prescribed RAASi were 0.114, 0.116, and 0.142 (0.079, 0.080, and 0.098) for K+ levels of 4.5, 5.5 and 6.5 mEq/L, respectively; equivalent mortality rates for HF patients were 0.196, 0.210, and 0.316 (0.152, 0.164, and 0.246). RAASi discontinuation rates were 0.326, 0.419, and 0.576 (0.278, 0.358, and 0.492) in CKD and 0.407, 0.473, and 0.674 (both genders) in HF, for K+ levels of 4.5, 5.5 and 6.5 mEq/L, respectively. Discontinuing RAASi was associated with increased mortality risk: 0.263, 0.269, and 0.329 (0.182, 0.186, and 0.228) in CKD and 0.652, 0.701, 1.055 (0.508, 0.546, and 0.821) in HF, for K+ levels of 4.5, 5.5 and 6.5 mEq/L, respectively. Conclusions: Based on real-world UK data, this study highlights the strong association between elevated K+ levels and increased incidence of RAASi discontinuation and mortality. The risk outputs from this study are fit for use within long-term cost-effectiveness models assessing the benefits of effective K+ management in CKD and HF. PHP175 Willingness-To-Pay For Life-Saving Treatments In Thailand: A Discrete Choice Experiment Nimdet K1, Ngorsuraches S2 1Suratthani Provincial Public Health Office, Surat thani, Thailand, 2South Dakota State University, Brookings, SD, USA
Objectives: Many countries currently use cost-effectiveness threshold to guide their decisions on the selection of new healthcare technologies. However, individual’s willingness-to-pay (WTP) is essential to justify these decisions, especially for life-saving treatments since they tend to be more expensive. This study aimed to examine WTP for life-saving treatments. Methods: Dimensions and levels from EQ-5D-3L, and cost were used to develop a discrete choice experiment questionnaire. Each questionnaire was composed of five choice sets. Each choice set contained two alternatives with different levels across all dimensions and a reference alternative (death and cost= 0). Four hundred and eighty five respondents were conveniently sampled from three provinces in Thailand. They were asked to imagine that they had a life-threatening disease for one year. If they did not get any treatment, they would die. They could choose only one alternative in each choice set. A multinomial logit model using effect codes was developed and used to calculate the WTP of each level change for each attribute. The WTP for saving life and getting back to current health state was calculated. Results: A total of 459 respondents (approximately 94% of all sampled respondents) completed the questionnaire. The average utility score of their current health states was 0.826 + 0.170. Intuitively, the respondents preferred better health states. They were willingness to pay 161,000 Baht, 153,000 Baht, 126,000 Baht, 114,000 Baht, and 80,000 Baht for having no problem in pain/ discomfort, mobility, usual activities, self-care, and anxiety/depression, respectively. Their average WTP for saving life and getting back to current health state after having a treatment for one year was 1,250,000 Baht. Conclusions: Thai citizens might be willing to pay for life-saving treatments higher than the cost-effectiveness threshold (160,000 Baht per QALY) that the country guideline currently suggests. Policy makers can use this finding when they select life-saving treatments. PHP176 Development Of A Mortality Risk Prediction Tool For Patients With Heart Failure Or Chronic Kidney Disease At Risk Of Hyperkalaemia Bennett H1, McEwan P1, Ayoubkhani D1, Evans M2, Qin L3, Kim K4, Palaka E5 Economics and Outcomes Research Ltd, Cardiff, UK, 2University Hospital Llandough, Cardiff, UK, 3AstraZeneca, Gaithersburg, MD, USA, 4AstraZeneca, Södertälje, Sweden, 5AstraZeneca, Cambridge, UK
1Health
Objectives: Hyperkalaemia (HK) is associated with increased risk of mortality. This study aimed to develop a risk prediction tool to assess the probability of mortality in patients with heart failure (HF) or chronic kidney disease (CKD) at risk of HK, based on relevant demographics and clinical risk factors. Methods: Poisson Generalized Estimating Equations fitted to 23,541 HF and 144,388 CKD patients in Clinical Practice Research Datalink (Jan 2006–Dec 2015) were incorporated within an Excel-based tool to predict annual probabilities of mortality using demographic, comorbidity, concomitant medication and clinical measurement data. An illustration of the tool’s output is presented relative to a baseline probability for a male/
female with CKD/HF, non-smoker, aged 60, eGFR 50 ml/min/1.73m2, serum potassium (K+) 4.5 mEq/L, without diabetes or renin-angiotensin-aldosterone system inhibitor (RAASi) prescription. Results were expressed as percentage increase/ decrease from baseline. Results: The listed characteristics were all statistically significant predictors of mortality. Baseline annual mortaility probability was 0.016 and 0.068 in males and 0.008 and 0.055 in females, with CKD and HF, respectively. RAASi use was associated with decreased probability of death compared to baseline in CKD (56.6%) and HF (69.3%). Older age, increased K+, diabetes, smoking and reductions in eGFR all increased estimated probability of death. The influence of eGFR was greater for CKD patients (36.4%–153% for 10–30 ml/min/1.73m2 reduction) compared to HF (18.4%–65.2% for 10–30 ml/min/1.73m2 reduction). While the impact of K+ was greater for HF: 7.2% and 58.4% for K+ 5.5 and 6.5 mEqL, respectively, compared to 2.1% and 24.9% for CKD. Conclusions: Utilising real-world UK data, this evaluation of the impact of clinical risk factors on mortality risk in patients with CKD or HF serves as the structural framework for a broader tool to enhance the assessment of risk of outcomes in patients susceptible to HK. PHP177 The First EQ-5D-5L Value Set In Central And Eastern Europe Golicki D1, Jakubczyk M2, Graczyk K3, Niewada M1 of Clinical & Experimental Pharmacology, Medical University of Warsaw, Warsaw, Poland, 2SGH Warsaw School of Economics, Warsaw, Poland, 3HealthQuest, Warsaw, Poland 1Department
Objectives: There is no EQ-5D-5L value set for any Central and Eastern European country. Our objective was to derive a tariff for the EQ-5D-5L in Poland. Methods: Quota sampling was used to achieve a representative sample of the Polish population with regard to age, sex, education, geographical region, and the size of locality. The study design followed the EQ-VT protocol (v2.0). Fifteen trained professional interviewers performed computer-assisted face-to-face interviews between June and October 2016. Each respondent valued ten health states using composite time trade-off (cTTO) and completed seven discrete choice experiment (DCE) tasks. Quality control was performed according to EQ-VT rules. All the flagged interviews were removed. The hybrid model was estimated in Bayesian setting, with noninformative priors, using JAGS/R environment. Results: Data from 1252 respondents (52.5% females, age 18 - 91 years) were available. In the estimation, we used: 11,480 TTO valuations and 8,764 DCE pairs. In TTO, in 10.7% experiments, the time was not traded, and eight respondents did not trade for any state. The average utility of 55555 state in TTO amounted to -0.433. In the final model, the estimated decrease of utility for level five amounts to: 0.341 (Mobility), 0.312 (Self-Care), 0.237 (Usual Activities), 0.592 (Pain/Discomfort), and 0.249 (Anxiety/Depression). In the final value set we got u(22222) = 0.889, u(33333) = 0.832, u(44444) = 0.375, u(55555) = -0.731 (compare to u(33333) = -0.523 in the Polish EQ-5D-3L tariff). Conclusions: New value set is available and should be used in health technology assessment in Poland. It may be considered as a second best choice in other CEE countries, lacking their own directly measured or cross-walk value sets. The new tariff does not introduce revolutionary changes as compared to the previous EQ-5D-3L version but offers greater sensitivity to subtle health state changes thanks to five levels. PHP178 The Role Of Disability On Early Retirement Laires PA1, Gouveia M2, Canhão H3, Branco JC4 1Escola Nacional de Saúde Pública. Universidade NOVA de Lisboa, Lisbon, Portugal, 2Católica Lisbon School of Business and Economics, Lisbon, Portugal, 3Sociedade Portuguesa de Reumatologia, Lisboa, Portugal, 4Sociedade Portuguesa de Reumatologia, Lisbon, Portugal
Objectives: To examine the role of disability on early retirement in Portugal. Methods: We analyzed data from a nationwide epidemiological study performed between September 2011 and December 2013 (EpiReumaPt Study) consisting of a representative sample of the population with 10,661 surveyees. Data was self-reported and comprises sociodemographic and clinical variables (including major chronic diseases, such as cardiovascular, respiratory, gastrointestinal, mental disorders, neurological, rheumatic diseases and cancer). We analyzed those aged 50-64, near the official retirement age. Disability was measured according with the Health Assessment Questionnaire (HAQ). The association between disability and early retirement was estimated using multivariable logistic regression. Results: About 30% (29.9%) of the Portuguese population aged between 50 and 64 was retired and had a mean HAQ score of 0.33 (95% CI: 0.31-0.36). Women self-reported worse HAQ scores (mean: 0.45 versus men: 0.20, p< 0.001), while those with at least one major chronic disease were more likely to have higher mean HAQ scores (0.38 vs. 0.11, p< 0.001). Retirees presented worse disability compared with any other occupational status (mean HAQ average for retired: 0.44; unemployed: 0.34; and employed: 0.22). In fact, disability was significantly associated with early retirement (age- region- and sex-adjusted OR: 1.77; 95% CI: 1.39-2.27; p< 0.001), while the relationship between morbidity and this occupational outcome is only significant when disability is high (OR: 1.97; 95% CI: 1.44-2.70; p= NS). On the other hand, those with low disability are more likely to be employed regardless of their self-reported morbidity (OR: 1.94; 95% CI: 1.50-2.51; p< 0.001). Conclusions: Disability is an important intermediate step in the causal chain between morbidity and early retirement and should be addressed in policies aiming to reduce premature work withdrawal. HAQ assessment could be a relevant tool to be applied regularly in the workplace for those at risk of early retirement, namely sick employees near the statutory retirement age. PHP179 Reliability And Validity Of Two Proxy Versions Of EQ-5D-5L In Japan Noto S1, Igarashi A2, Shiroiwa T3, Fukuda T3, Ikeda S4, Moriwaki K5, Saito S6, Shimozuma K7, Ishida H8, Kobayashi M9 1Niigata University of Health and Welfare, Niigata, Japan, 2University of Tokyo, Tokyo, Japan, 3National Institute of Public Health, Wako, Japan, 4International University of Health and Welfare, Ohtawara, Japan, 5Kobe Pharmaceutical University, Kobe, Japan, 6Okayama University, Okayama, Japan, 7Ritsumeikan University, Kusatsu, Japan, 8Yamaguchi University Graduate School of Medicine, Ube, Japan, 9CRECON Medical Assessment Inc., Tokyo, Japan