研究者詳細 - 後藤　励

論文 - 後藤　励

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Trends in the integration of medical corporation hospitals in Japan: a national wide longitudinal study between 2017 and 2021

Funada S., Luo Y., Kato H., Yoshioka T., Uno S., Honda K., Akune Y., Goto R.

BMC Health Services Research 24 （ 1 ） 2024年12月

Background: Medical corporations, which are non-profit organizations that aim to operate hospitals, clinics, or long-term care facilities, account for more than half of all hospital beds and play a central role in the health care system in Japan. However, limited analysis of hospital integration has been performed. Examining the hospital integration trends of medical corporations can provide valuable insights for optimizing health care delivery and resource allocation in Japan. This study conducted a comprehensive analysis of trends in the hospital integration of medical corporations and market concentration in Japan using nationwide longitudinal data. Methods: This longitudinal study evaluated the hospital integration of medical corporations in Japan between 2017 and 2021 using medical corporation financial data provided by the Neostage Company. The target population was medical corporations that own hospitals in Japan. The primary outcomes were the horizontal and vertical integration of medical corporation hospitals. Horizontal integration was defined as the integration of two or more hospitals within the same corporation, while vertical integration was defined as the integration of a hospital with different types of health care facilities, such as clinics or long-term care facilities, within a single medical corporation. The Herfindahl–Hirschman Index (HHI) was calculated to measure hospital market concentration using hospital bed data for medical corporations in all prefectures. Results: The number of hospitals and hospital beds within medical corporations decreased from 5,670 to 848,174 in 2017 to 5,486 and 814,462 in 2021, respectively. Both horizontal and vertical integration among medical corporation facilities showed a gradual upward trend, increasing from 24.92% to 55.75% in 2017 to 26.92% and 59.42% in 2021, respectively. The mean (standard deviation [SD]) HHI increased slightly from 262.7 (178.6) in 2017 to 275.2 (187.9) in 2021, with rural areas being more concentrated than urban areas, although both remained unconcentrated. Conclusions: This longitudinal study revealed a gradual downward trend in the number of hospitals and hospital beds owned by medical corporations, while horizontal and vertical integration gradually progressed without any particular medical corporation dominating the market. These findings are expected to contribute to policymaking efforts aimed at providing optimal health care services in Japan.

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A cost-effectiveness analysis of three surgical options for treating displaced femoral neck fractures in active older patients in Japan: A full economic evaluation

Yokoyama K., Akune Y., Katoh H., Bito S., Fujita Y., Goto R., Yamauchi K.

PLoS ONE 19 （ 10 October ） 2024年10月

For older patients with displaced femoral neck fractures, in which primary osteosynthesis is usually not indicated, there are three primary prosthetic options—bipolar hemiarthroplasty (BHA), single-bearing total hip arthroplasty (SB-THA), and dual-mobility THA (DM-THA). However, the optimal choice for managing displaced femoral neck fractures remains controversial. Accordingly, this study aimed to evaluate the cost-effectiveness of BHA, SB-THA, and DM-THA in active older patients with displaced femoral neck fractures. A decision tree combined with a Markov model was employed to analyze the cost and quality-adjusted life years (QALYs) of BHA, SB-THA, and DM-THA for the management in the Japanese healthcare system. By simulating the five-year trajectory of a 75-year-old woman treated for a displaced femoral neck fracture, the cost-effectiveness of the three surgical options was evaluated. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were used to assess parameter uncertainty. Additionally, two scenario analyses were conducted for other settings. The treatment was considered to be cost-effective when the incremental cost-effectiveness ratio (ICER) was below the 5,000,000 yen/QALY threshold. Compared with BHA, SB-THA exhibited higher costs but greater health benefits, resulting in an ICER of 1,499,440 yen/QALY. DM-THA offered additional health benefits compared with SB-THA, with an ICER of 4,145,777 yen/QALY. One-way sensitivity analysis revealed some influential parameters. PSA indicated that the probability of DM-THA, SB-THA, and BHA being cost-effective was 40.1%, 38.5%, and 21.4%, respectively. SB-THA was more cost-effective than BHA in patients aged 65–85 years, while DM-THA was more cost-effective than SB-THA in patients aged 65–75 years. The results suggest that SB-THA is a cost-effective alternative to BHA for displaced femoral neck fractures in active older patients, whereas DM-THA is more cost-effective than SB-THA in relatively younger patients. It is, therefore, recommended that orthopedic surgeons select the most appropriate surgical option based on the individual patient’s physiological age.

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Cost-effectiveness of behavioural counselling intervention compared with non-intervention for adult patients with metabolic syndrome to prevent cardiovascular diseases and type 2 diabetes in Japan: a microsimulation modelling study

Akune Y., Anezaki H., Nakao Y.M., Goto R.

BMJ Open （BMJ Open） 14 （ 4 ） 2024年04月

Objectives Nationwide lifestyle intervention—specific health guidance (SHG) in Japan—employs counselling and education to change unhealthy behaviours that contribute to metabolic syndrome, especially obesity or abdominal obesity. We aimed to perform a model-based economic evaluation of SHG in a low participation rate setting. Design A hypothetical population, comprised 50 000 Japanese aged 40 years who met the criteria of the SHG, used a microsimulation using the Markov model to evaluate SHG’s cost-effectiveness compared with non-SHG. This hypothetical population was simulated over a 35-year time horizon. Setting SHG is conducted annually by all Japanese insurers. Outcome measures Model parameters, such as costs and health outcomes (including quality-adjusted life-years, QALYs), were based on existing literature. Incremental cost-effectiveness ratios were estimated from the healthcare payer’s perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to evaluate the uncertainty around the model input parameters. Results The simulation revealed that the total costs per person in the SHG group decreased by JPY53 014 (US$480) compared with that in the non-SHG group, and the QALYs increased by 0.044, wherein SHG was considered the dominant strategy despite the low participation rates. PSA indicated that the credibility intervals (2.5th–97.5th percentile) of the incremental costs and the incremental QALYs with the SHG group compared with the non-SHG group were −JPY687 376 to JPY85 197 (−US$6226 to US$772) and −0.009 to 0.350 QALYs, respectively. Each scenario analysis indicated that programmes for improving both blood pressure and blood glucose levels among other risk factors for metabolic syndrome are essential for improving cost-effectiveness. Conclusions This study suggests that even small effects of counselling and education on behavioural modification may lead to the prevention of acute life-threatening events and chronic diseases, in addition to the reduction of medication resulting from metabolic syndrome, which results in cost savings.

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ビジネスパーソンのための医療経済学

後藤励

医療経済研究（医療経済学会/医療経済研究機構） 35 （ 2 ） 63 - 64 2024年03月

ISSN 1340895X

Cost-effectiveness Analysis of Nivolumab Plus Ipilimumab Combination Therapy as First-line Treatment for Advanced Renal Cell Carcinoma in Japan

Maeda T., Moriwaki K., Morimoto K., Mo X., Yoshioka T., Goto R., Shimozuma K.

Value in Health Regional Issues （Value in Health Regional Issues） 40 118 - 126 2024年03月

ISSN 22121099

Objectives: The purpose of this study is to examine the cost-effectiveness of nivolumab (NIVO) plus ipilimumab (IPI) combination therapy (NIVO + IPI) compared with the sunitinib (SUN) therapy for Japanese patients with advanced renal cell carcinoma from the perspective of a Japanese health insurance payer. Methods: A lifetime horizon was applied, and 2% per annum was set as the discount rate. The threshold was set as $ 75 000 per quality-adjusted life-year (QALY) gained. For the analytical method, we used a partitioned survival analysis model to estimate the incremental cost-effectiveness ratio (ICER), which is calculated by dividing incremental costs by incremental QALYs. Progression-free survival, progressive disease, and death were set as health states. Additionally, cost parameters and utility weights were set as key parameters. We set the intermediate/poor-risk population as the base case. Scenario analysis was conducted for the intention-to-treat population and the favorable risk population. Furthermore, one-way sensitivity analysis and probabilistic sensitivity analysis were conducted for each population. Results: In the base-case analysis, the QALYs of NIVO + IPI and SUN were 4.32 and 2.99, respectively. NIVO + IPI conferred 1.34 additional QALYs. Meanwhile, the total costs in the NIVO + IPI and SUN were $692 288 and $475 481, respectively. As a result, the ICER of NIVO + IPI compared with SUN was estimated to be $162 243 per QALY gained. The parameter that greatly affected the ICER was the utility weight of progression-free survival in NIVO + IPI. Conclusions: NIVO + IPI for advanced renal cell carcinoma seems to be not cost-effective compared with the SUN in the Japanese healthcare system.

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Cost-Effectiveness of School Urinary Screening for Early Detection of IgA Nephropathy in Japan

Honda K., Akune Y., Goto R.

JAMA Network Open （JAMA Network Open） 7 （ 2 ） 2024年02月

IMPORTANCE The evidence for and against screening for chronic kidney disease in youths who are asymptomatic is inconsistent worldwide. Japan has been conducting urinary screening in students for 50 years, allowing for a full economic evaluation that includes the clinical benefits of early detection and intervention for chronic kidney disease. OBJECTIVES To evaluate the clinical effectiveness and cost-effectiveness of school urinary screening in Japan, with a focus on the benefits of the early detection and intervention for IgA nephropathy, and to explore key points in the model that are associated with the cost-effectiveness of the school urinary screening program. DESIGN, SETTING, AND PARTICIPANTS This economic evaluation with a cost-effectiveness analysis used a computer-simulated Markov model from the health care payer's perspective among a hypothetical cohort of 1 000 000 youths aged 6 years in first grade in Japanese elementary schools, followed up through junior and high school. The time horizon was lifetime. Costs and clinical outcomes were discounted at a rate of 2%per year. Costs were calculated in Japanese yen and 2020 US dollars (¥107 = US $1). INTERVENTIONS School urinary screening for IgA nephropathy was compared with no screening. MAIN OUTCOMES AND MEASURES Outcomes were costs and quality-adjusted life-years (QALYs). Cost-effectiveness was determined by evaluating whether the incremental cost-effectiveness ratio (ICER) per QALY gained remained less than ¥7 500 000 (US $70 093). RESULTS In the base case analysis, the ICERwas ¥4 186 642 (US $39 127)/QALY, whichwas less than the threshold. There were 60.3 patients/1 000 000 patients in the no-screening strategy and 31.7 patients/1 000 000 patients in the screening strategy with an end-stage kidney disease. Costeffectiveness improved as the number of screenings decreased (screening frequency <3 times: incremental cost, -¥75 [US $0.7]; incremental QALY, 0.00025; ICER, dominant), but the number of patients with end-stage kidney disease due to IgA nephropathy increased (40.9 patients/1 000 000 patients). Assuming the disutility due to false positives had a significant impact on the analysis; assuming a disutility of 0.01 or more, the population with no IgA nephropathy had an ICER greater than the threshold (¥8 304 093 [US $77 608]/QALY). CONCLUSIONS AND RELEVANCE This study found that Japanese school urinary screening was cost-effective, suggesting that it may be worthy of resource allocation. Key factors associated with cost-effectiveness were screening cost, the probability of incident detection outside of screening, and IgA nephropathy incidence, which may provide clues to decision-makers in other countries when evaluating the program in their own context.

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Protocol digest of a randomized controlled Phase III study comparing surgery alone versus adjuvant nivolumab versus adjuvant S-1 for locally advanced oesophageal squamous cell carcinoma with no pathological complete response after neoadjuvant chemotherapy followed by curative esophagectomy: Japan Clinical Oncology Group study JCOG2206 (SUNRISE Trial)

Kita R., Matsuda S., Nomura M., MacHida R., Sasaki K., Kato K., Goto R., Yoshioka T., Yamamoto S., Tsushima T., Fukuda H., Takeuchi H., Kitagawa Y.

Japanese Journal of Clinical Oncology （Japanese Journal of Clinical Oncology） 54 （ 2 ） 212 - 216 2024年02月

ISSN 03682811

Although the efficacy of postoperative therapy with nivolumab after preoperative chemoradiotherapy for locally advanced oesophageal cancer has been proven in Western countries, the survival benefits of postoperative therapy after preoperative chemotherapy with docetaxel, cisplatin and 5-FU or cisplatin plus 5-FU as the Japanese standard therapy remain controversial. This randomized Phase III trial was designed to confirm the superiority of postoperative therapy with nivolumab over observation alone and S-1 over observation alone in patients with locally advanced oesophageal squamous cell carcinoma with no pathological complete response after preoperative chemotherapy followed by curative esophagectomy. A total of 450 patients will be enrolled from 56 hospitals in Japan over 5.5 years. The primary endpoint is relapse-free survival, and the secondary endpoints are disease-free survival, overall survival, adverse events and incremental cost-effectiveness ratio. This trial has been registered in the Japan Registry of Clinical Trials as jRCTs031230219 (https://jrct.niph.go.jp/latest-detail/jRCTs031230219).

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Cost-Effectiveness of Universal Asymptomatic Preoperative SARS-CoV-2 Polymerase Chain Reaction Screening: A Cost-Utility Analysis

Uno S., Goto R., Honda K., Uchida S., Uwamino Y., Namkoong H., Yoshifuji A., Mikita K., Takano Y., Matsumoto M., Kitagawa Y., Hasegawa N.

Clinical Infectious Diseases （Clinical Infectious Diseases） 78 （ 1 ） 57 - 64 2024年01月

ISSN 10584838

Background: An early report has shown the clinical benefit of the asymptomatic preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening test, and some clinical guidelines recommended this test. However, the cost-effectiveness of asymptomatic screening was not evaluated. We aimed to investigate the cost-effectiveness of universal preoperative screening of asymptomatic patients for SARS-CoV-2 using polymerase chain reaction (PCR) testing. Methods: We evaluated the cost-effectiveness of asymptomatic screening using a decision tree model from a payer perspective, assuming that the test-positive rate was 0.07% and the screening cost was 8500 Japanese yen (JPY) (approximately 7601 US dollars [USD]). The input parameter was derived from the available evidence reported in the literature. A willingness-to-pay threshold was set at 5 000 000 JPY/quality-adjusted life-year (QALY). Results: The incremental cost of 1 death averted was 74 469 236 JPY (approximately 566 048 USD) and 291 123 368 JPY/QALY (approximately 2 212 856 USD/QALY), which was above the 5 000 000 JPY/QALY willingness-to-pay threshold. The incremental cost-effectiveness ratio fell below 5 000 000 JPY/QALY only when the test-positive rate exceeded 0.739%. However, when the probability of developing a postoperative pulmonary complication among SARS-CoV-2-positive patients was below 0.22, asymptomatic screening was never cost-effective, regardless of how high the test-positive rate became. Conclusions: Asymptomatic preoperative universal SARS-CoV-2 PCR screening is not cost-effective in the base case analysis. The cost-effectiveness mainly depends on the test-positive rate, the frequency of postoperative pulmonary complications, and the screening costs; however, no matter how high the test-positive rate, the cost-effectiveness is poor if the probability of developing postoperative pulmonary complications among patients positive for SARS-CoV-2 is sufficiently reduced.

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特集リハビリテーションの医療経済学医療政策の経済学的評価

後藤励

総合リハビリテーション（株式会社医学書院） 52 （ 1 ） 35 - 41 2024年01月

ISSN 03869822

Willingness to pay for nationwide wastewater surveillance system for infectious diseases in Japan

Yoo B.K., Goto R., Kitajima M., Sasaki T., Himmler S.

Environmental Science: Water Research and Technology （Environmental Science: Water Research and Technology） 11 （ 1 ） 29 - 38 2024年

ISSN 20531400

COVID-19 motivated the US and the European Union to establish a regular pathogen surveillance system at wastewater treatment plants, but other countries, including Japan, have been reluctant to adopt such a system. To determine whether a continuous pathogen surveillance system at wastewater treatment plants is economically justifiable in Japan, we conducted a contingent valuation experiment to estimate a hypothetical willingness to pay (WTP) for such a surveillance system. To collect primary data, an online WTP experiment was administered to a nationally representative sample in Japan in spring 2023 (N = 2457). Results indicated that mean WTP was US $23.47 (Median $8.83) per household per year, and that around 97% of individuals had a non-zero WTP. The monetary valuation aggregated to the national level ($497 million based on the median value) exceeds the likely costs of maintaining the system in Japan ($33 million). Based on the population's valuation of the nationwide wastewater surveillance system, its establishment would be economically justifiable in Japan. Our results are expected to inform stakeholders in Japan, the US, the European Union, and other countries considering expanding or maintaining wastewater surveillance systems that are applicable for diverse infectious diseases including COVID-19. For a future epidemic with uncertain risks, the surveillance systems' economic efficiency (e.g., cost-effectiveness and return-on-investment) is difficult to assess. Eliciting taxpayers' WTP can be informative for that purpose.

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Transportation for Patients with Stroke in Need of Mechanical Thrombectomy: A Simulation-Based Study in Hyogo Prefecture, Japan

Yamasaki Bumpei, Goto Rei, Imamura Hirotoshi, Sakai Nobuyuki

脳神経血管内治療（一般社団法人日本脳神経血管内治療学会） 18 （ 12 ） 305 - 312 2024年

ISSN 18824072

Objective: This study aimed to simulate patient transportation to a mechanical thrombectomy (MT)-capable hospital within 60 minutes, taking into account patient volume (demand side of healthcare) and hospital capacity to accept patients (supply side of healthcare).Methods: Simulations were conducted in Hyogo Prefecture, Japan. The estimates of the annual number of patients with stroke eligible for MT in 2020 were based on the incidence of stroke by age group and the percentage of patients with stroke indicated for MT in existing publications. Patients were then randomly placed on a 1 km2 mesh map. The patients were randomly generated 100 times using R software (version 4.1.2; R Foundation for Statistical Computing, Vienna, Austria). Hospitals were selected based on 2 criteria: (1) actual provision patterns (39 hospitals) and (2) consolidated patterns (12 hospitals). Simulations were performed using ArcGIS Pro (version 10.8; Esri, Redlands, CA, USA) and Network Analyst extension (Esri) in 3 cases: (1) number of patients estimated from the population in 2020 transported to hospitals that provided MT, (2) number of patients estimated based on the 2020 population transported to selected hospitals in the case of consolidation, and (3) number of patients estimated based on 2040’s projected population and transportation to the selected hospitals.Results: In Case 1, the estimated annual number of patients undergoing MT in 2020 was 976. The average number of patients undergoing MT and transported was 961, indicating that 98% (961/976) of the total generated patients could be transported within 60 min. In Case 2, the average number of patients undergoing MT and transported was 940, indicating that 96.3% (940/976) of the total patients could be transported within 60 min. In Case 3, the average number of patients undergoing MT and transported was 1184, showing that 95.1% (1184/1244) of the total generated patients could be transported within 60 min. A few patients in rural areas and remote islands required longer transport times.Conclusion: The simulations showed that patient estimates from the incidence of cerebral infarction by age group and the percentage of patients with stroke indicated for MT were similar to the actual values. The simulation was closed to reality when both the supply and demand sides of healthcare were considered. Thus, this simulation study informs future healthcare policy by demonstrating the geographic distribution of human and capital resources and potential cost reduction through consolidation, taking into account demographic changes.

The estimation of healthcare cost of kidney transplantation in Japan using large-scale administrative databases

Hasegawa M., Kato H., Yoshioka T., Goto R.

Clinical and Experimental Nephrology 29 （ 3 ） 350 - 358 2024年

ISSN 13421751

Background: The financial burden of kidney replacement therapy (KRT) is considerable, and detailed information on KRT costs is essential for managing these huge healthcare costs. However, cost analyses for kidney transplantation (KTx) are limited in Japan. This study aimed to report the healthcare costs of KTx recipients in Japan based on large medical receipt data. Methods: This cost analysis of KTx recipients using the Japan Medical Data Center Claims Database between January 2005 and August 2020 identified living donor KTx (LDKT) and deceased donor KTx (DKT) recipients. The primary outcome was the total direct healthcare costs of KTx recipients. As an exploratory analysis, we examined the factors that contributed to the increase in the costs of LDKT. Results: In total, 84 LDKT and 17 DKT recipients were included in this study. The total healthcare costs for LDKT and DKT recipients during the first year after KTx were 6,639,982 and 6,840,450 JPY/year, respectively. However, after the second year post-KTx, total healthcare costs decreased to 1,735,931 and 1,348,642 JPY/year for LDKT and DKT recipients, respectively. During the first year, inpatient costs accounted for > 70% of the total healthcare costs, whereas pharmaceutical costs accounted for more than half after the second year post-KTx. The use of everolimus and male sex were associated with higher and lower total healthcare costs in the first and subsequent years after LDKT, respectively. Conclusion: Using large-scale administrative databases, this study revealed the total healthcare costs of KTx in Japan and provided valuable information for the health technology assessment of KTx.

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Relationship between hospital surgical volume and the perioperative esophagectomy costs for esophageal cancer: a nationwide administrative claims database study

Sakamoto T., Nishigori T., Goto R., Kawakami K., Nakayama T., Tsunoda S., Hisamori S., Hida K., Obama K.

Esophagus 22 （ 1 ） 27 - 36 2024年

ISSN 16129059

Background: Numerous studies have described positive relationships between hospital volume (HV) and clinical outcomes in highly complex procedures, including esophagectomies. Although the centralization of surgery has been considered a possible solution for improving clinical outcomes, the HV impact on perioperative healthcare costs is unknown. This study aimed to determine the relationship between HV and perioperative healthcare costs for patients undergoing esophagectomy for esophageal cancer. Methods: This retrospective, nationwide cohort study used Japanese Administrative Claims Database data. Data on esophagectomies performed nationwide in 2015 were extracted. The outcome measure was perioperative healthcare costs per person from the perspective of the insurer. The healthcare costs in outpatient or inpatient settings of any hospital and clinic where patients received treatment were summed up from the month the surgery was performed to 3 months after. Linear regression analyses were conducted to assess the risk-adjusted effects of the HV category (1–4/5–9/10–14/15–) on perioperative costs. Results: A total of 5232 patients underwent an esophagectomy at 584 hospitals. The overall perioperative cost was 20.834 billion Japanese yen (JPY). The median perioperative costs per person for each HV category (1–4/5–9/10–14/15–) were 3.728 (709 patients), 3.740 (658 patients), 3.760 (512 patients), and 3.760 (3253 patients) million JPY, respectively (P = 0.676). Multivariate analyses revealed that each HV category had no significant impact on perioperative costs. Conclusions: There were no significant differences in the perioperative costs between high- and low-volume centers. Esophageal cancer surgery centralization may be achievable without increasing healthcare costs.

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連載医療システムの質・効率・公正--医療経済学の新たな展開・Vol.18 保健医療の経済学と行動経済学

後藤励

医学のあゆみ（医歯薬出版） 287 （ 10 ） 789 - 794 2023年12月

ISSN 00392359

Healthcare costs for hospitalized COVID-19 patients in a Japanese university hospital: a cross-sectional study

Uno S., Goto R., Honda K., Tokuda M., Kamata H., Chubachi S., Yamamoto R., Sato Y., Homma K., Uchida S., Namkoong H., Uwamino Y., Sasaki J., Fukunaga K., Hasegawa N.

Cost Effectiveness and Resource Allocation （Cost Effectiveness and Resource Allocation） 21 （ 1 ） 2023年12月

Background: A health-economic evaluation related to COVID-19 is urgently needed to allocate healthcare resources efficiently; however, relevant medical cost data in Japan concerning COVID-19 are scarce. Methods: This cross-sectional study investigated the healthcare cost for hospitalized COVID-19 patients in 2021 at Keio University Hospital. We calculated the healthcare costs during hospitalization using hospital claims data and investigated the variables significantly related to the healthcare cost with multivariable analysis. Results: The median healthcare cost per patient for the analyzed 330 patients was Japanese yen (JPY) 1,304,431 (US dollars ~ 11,871) (interquartile range: JPY 968,349–1,954,093), and the median length of stay was 10 days. The median healthcare cost was JPY 798,810 for mild cases; JPY 1,113,680 for moderate I cases; JPY 1,643,909 for moderate II cases; and JPY 6,210,607 for severe cases. Healthcare costs increased by 4.0% for each additional day of hospitalization; 1.26 times for moderate I cases, 1.64 times for moderate II cases, and 1.84 times for severe cases compared to mild cases; and 2.05 times for cases involving ICU stay compared to those not staying in ICU. Conclusions: We clarified the healthcare cost for hospitalized COVID-19 patients by severity in a Japanese university hospital. These costs contribute as inputs for forthcoming health economic evaluations for strategies for preventing and treating COVID-19.

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Comprehensive analysis of long COVID in a Japanese nationwide prospective cohort study

Terai H., Ishii M., Takemura R., Namkoong H., Shimamoto K., Masaki K., Tanosaki T., Chubachi S., Matsuyama E., Hayashi R., Shimada T., Shigematsu L., Ito F., Kaji M., Takaoka H., Kurihara M., Nakagawara K., Tomiyasu S., Sasahara K., Saito A., Otake S., Azekawa S., Okada M., Fukushima T., Morita A., Tanaka H., Sunata K., Asaoka M., Nishie M., Shinozaki T., Ebisudani T., Akiyama Y., Mitsuishi A., Nakayama S., Ogawa T., Sakurai K., Irie M., Yagi K., Ohgino K., Miyata J., Kabata H., Ikemura S., Kamata H., Yasuda H., Kawada I., Kimura R., Kondo M., Iwasaki T., Ishida N., Hiruma G., Miyazaki N., Ishibashi Y., Harada S., Fujita T., Ito D., Bun S., Tabuchi H., Kanzaki S., Shimizu E., Fukuda K., Yamagami J., Kobayashi K., Hirano T., Inoue T., Haraguchi M., Kagyo J., Shiomi T., Lee H., Sugihara K., Omori N., Sayama K., Otsuka K., Miyao N., Odani T., Watase M., Mochimaru T., Satomi R., Oyamada Y., Masuzawa K., Asakura T., Nakayama S., Suzuki Y., Baba R., Okamori S., Arai D., Nakachi I., Kuwahara N., Fujiwara A., Oakada T., Ishiguro T., Isosno T., Makino Y., Mashimo S., Kaido T., Minematsu N., Ueda S., Minami K., Hagiwara R., Manabe T., Fukui T.

Respiratory Investigation （Respiratory Investigation） 61 （ 6 ） 802 - 814 2023年11月

ISSN 22125345

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly since 2019, and the number of reports regarding long COVID has increased. Although the distribution of long COVID depends on patient characteristics, epidemiological data on Japanese patients are limited. Hence, this study aimed to investigate the distribution of long COVID in Japanese patients. This study is the first nationwide Japanese prospective cohort study on long COVID. Methods: This multicenter, prospective cohort study enrolled hospitalized COVID-19 patients aged ≥18 years at 26 Japanese medical institutions. In total, 1200 patients were enrolled. Clinical information and patient-reported outcomes were collected from medical records, paper questionnaires, and smartphone applications. Results: We collected data from 1066 cases with both medical records and patient-reported outcomes. The proportion of patients with at least one symptom decreased chronologically from 93.9% (947/1009) during hospitalization to 46.3% (433/935), 40.5% (350/865), and 33.0% (239/724) at 3, 6, and 12 months, respectively. Patients with at least one long COVID symptom showed lower quality of life and scored higher on assessments for depression, anxiety, and fear of COVID-19. Female sex, middle age (41–64 years), oxygen requirement, and critical condition during hospitalization were risk factors for long COVID. Conclusions: This study elucidated the symptom distribution and risks of long COVID in the Japanese population. This study provides reference data for future studies of long COVID in Japan.

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Efficacy and safety of a telemedicine system in subjects with gestational diabetes mellitus (TELEGLAM): Study protocol for a randomized controlled trial

Aoyama K., Nakajima Y., Meguro S., Sato Y., Goto R., Hida M., Arimitsu T., Kasuga Y., Tanaka M., Itoh H.

Heliyon （Heliyon） 9 （ 11 ） 2023年11月

ISSN 24058440

Background: Strict glycemic control is important to prevent perinatal complications in patients with gestational diabetes mellitus (GDM). Patients often require insulin injection, and frequent hospital visits are necessary to adjust the dose of insulin, which is considered burdensome for pregnant patients. Telemedicine may reduce the burden of hospital visits, and previous studies have reported its safety in GDM patients. This study aimed to evaluate the efficacy of telemedicine in GDM patients, focusing on patient satisfaction and health economic indicators. Methods: This is a single-center, two-arm, randomized, open-label parallel-group study. Subjects will be selected from the patient population attending the Department of Endocrinology, Metabolism, and Nephrology, Keio University School of Medicine, Japan. Patients diagnosed with GDM by an oral glucose tolerance test (OGTT) by 29 weeks and 6 days of gestation who have undergone self-monitoring of blood glucose (SMBG) and insulin injection are eligible for inclusion. In the intervention group, telemedicine will be administered using the MeDaCa telemedicine system developed by the Medical Data Card, Inc., Tokyo, Japan. Subjects in the control group will be examined face-to-face every 2–3 weeks, as usual. We set health economic indicators and patient satisfaction as the primary endpoints, and will perform a cost-consequence analysis. Glycemic control indicators and perinatal outcomes will be evaluated as secondary endpoints. Conclusions: Eligible patients are currently being recruited. Recruitment will be completed when the expected number of patients are enrolled.

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Effect of influenza vaccine subsidies for older adults on vaccination coverage and mortality before and during the COVID-19 pandemic: an ecological study in Japan

Ando T., Ibuka Y., Goto R., Haruta J., Le D.D., Fujishima S.

Public Health （Public Health） 224 152 - 158 2023年11月

ISSN 00333506

Objective: We aimed to determine how municipal subsidies for seasonal influenza vaccines for the elderly affected vaccination coverage and health outcomes and how responses to vaccine prices changed during the COVID-19 pandemic. Study design and methods: This ecological study includes 1245 municipalities in Japan between 2019 and 2020. Fixed-effects regression analysis was performed to evaluate the effect of influenza vaccine cost subsidy for people aged 65 years or older on vaccination coverage, all-cause mortality, and influenza-related mortality. Results: The vaccination rate increased when patients' copayments decreased, and reducing the copayment by 1000 Japanese Yen (JPY) was estimated to increase the vaccination rate by 6.3% (95% confidence interval [CI] 4.5–8.2%) in the adjusted model. When examining the additional effect of a zero price compared to a nearly zero price, we found that a zero price increased the immunization rate by 6.4% (95% CI 1.4–11.5%). The effect of copayment on the increase in vaccination coverage was significantly lower during the pandemic than in the pre-pandemic period. The municipal and prefectural analyses found no association between influenza vaccine copayments and all-cause, influenza, or pneumonia mortality. Conclusion: Cost subsidies and the zero-price effect were shown to increase vaccination coverage but were not associated with relevant mortality measures. Although the impact was attenuated under pandemic conditions, cost subsidy effectively increases the vaccination rate.

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Effect of aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on incidence of surgical site infections in gastrointestinal surgery: multicentre randomised controlled clinical trial (OEDO trial) protocol

Takeuchi M., Obara H., Furube T., Kawakubo H., Kitago M., Okabayashi K., Aoyama J., Amemiya R., Fujisaki H., Sano J., Goto R., Sato Y., Kitagawa Y.

BMJ Open （BMJ Open） 13 （ 8 ） 2023年08月

Introduction Surgical site infections (SSIs) are among the most common nosocomial infections in surgery patients. Two types of preparations, povidone-iodine and chlorhexidine-alcohol, are commonly used in preoperative antiseptic procedures worldwide. However, there are inconsistencies among international guideline recommendations concerning skin antiseptics. This trial aimed to evaluate the superiority of olanexidine, which reduced SSI rates more than povidone-iodine in our previous randomised trial, over chlorhexidine-alcohol in clean-contaminated surgery. Methods and analysis This multicentre randomised controlled clinical trial will compare two antiseptics (1.5% olanexidine and 1.0% chlorhexidine-alcohol) to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. On providing consent, patients aged <18 years will be included. The primary outcome will be the postoperative 30-day overall SSI rate, while the secondary outcomes will be the postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, positive bacterial wound culture rate, cultured bacterial strains, rates of intervention-related toxicity and allergic events (eg, erythema, pruritus, dermatitis and other symptoms of allergy around the region disinfected by the antiseptic during surgery), rate of reoperations due to SSI, medical economic effect indicators (based on health insurance claims) and hospital duration. The Mantel-Haenszel method will be used to estimate the adjusted risk ratio and its 95% CI for the primary analysis, which will compare the treatment effects. Ethics and dissemination The protocol was approved by the Institutional Review Board of Keio University School of Medicine and subsequently by the board of each participating site. Participant recruitment began in January 2023. The final results will be published in medical journals after international peer review. Trial registration number UMIN000049712.

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【連載】行動変容をそっと促す　ナッジを使ったアプローチ(14) 「記録しないこと」には理由がある?

竹林正樹, 後藤励

コミュニティケア（株式会社日本看護協会出版会） 25 （ 9 ） 42 - 44 2023年07月

ISSN 27580008

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