| 1. |
Megumi Maeda, Fumiko Murata, Haruhisa Fukuda, Effect of COVID-19 vaccination on household transmission of SARS-CoV-2 in the Omicron era: The Vaccine Effectiveness, Networking, and Universal Safety (VENUS) study., International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 10.1016/j.ijid.2023.06.017, 134, 200-206, 2023.09, OBJECTIVES: To evaluate the effectiveness of vaccination on reducing household transmission of SARS-CoV-2 among common household types in Japan during the Omicron variant wave. METHODS: This retrospective study was conducted using vaccination records, COVID-19 infection data, and resident registry data from two Japanese municipalities. Households that experienced their first COVID-19 case between January and April 2022 were categorized into two groups according to the presence/absence of children aged ≤11 years. We constructed multivariable logistic regression models with generalized estimating equations to calculate the odds ratios (ORs) and 95% confidence intervals for household transmission according to the vaccination statuses of primary cases and household contacts. RESULTS: We analyzed 7326 households with 17,586 contacts. In all households, the OR for household transmission was |
| 2. |
Haruhisa Fukuda, Fumiko Murata, Sachie Azuma, Masahiro Fujimoto, Shoma Kudo, Yoshiyuki Kobayashi, Kenshi Saho, Kazumi Nakahara, Rei Ono, Development of a data platform for monitoring personal health records in Japan: The Sustaining Health by Integrating Next-generation Ecosystems (SHINE) Study, PLOS ONE, 10.1371/journal.pone.0281512, 18, 2, e0281512-e0281512, 2023.02, Background
The Sustaining Health by Integrating Next-generation Ecosystems (SHINE) Study was developed as a data platform that incorporates personal health records (PHRs) into health-related data at the municipal level in Japan. This platform allows analyses of the associations between PHRs and future health statuses, and supports the production of evidence for developing preventive care interventions. Herein, we introduce the SHINE Study’s profile and describe its use in preliminary analyses.
Methods
The SHINE Study involves the collection of participants’ health measurements and their addition to various health-related data from the Longevity Improvement & Fair Evidence (LIFE) Study. With cooperation from municipal governments, measurements can be acquired from persons enrolled in government-led long-term care prevention classes and health checkups who consent to participate in the SHINE Study. For preliminary analyses, we collected salivary test measurements, lifelog measurements, and gait measurements; these were linked with the LIFE Study’s database. We analyzed the correlations between these measurements and the previous year’s health care expenditures.
Results
We successfully linked PHR data of 33 participants for salivary test measurements, 44 participants for lifelog measurements, and 32 participants for gait measurements. Only mean torso speed in the gait measurements was significantly correlated with health care expenditures (r = -0.387, P = 0.029).
Conclusion
The SHINE Study was developed as a data platform to collect and link PHRs with the LIFE Study’s database. The analyses undertaken with this platform are expected to contribute to the development of preventive care tools and promote health in Japan.. |
| 3. |
Nobuhiro Narii, Tetsuhisa Kitamura, Sho Komukai, Ling Zha, Masayo Komatsu, Fumiko Murata, Megumi Maeda, Kosuke Kiyohara, Tomotaka Sobue, Haruhisa Fukuda, Association of pneumococcal vaccination with cardiovascular diseases in older adults: The vaccine effectiveness, networking, and universal safety (VENUS) study., Vaccine, 10.1016/j.vaccine.2023.02.077, 41, 13, 2307-2313, 2023.03, The protective effect of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) against cardiovascular disease has been investigated in the United States and Europe; however, its effect has not been fully established. This study aimed to investigate the protective effect of PPSV23 on cardiovascular events in adults aged ≥ 65 years. This population-based nested case-control study was conducted using the claims data and vaccine records between April 2015 and March 2020 from the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study. PPSV23 vaccination was identified using vaccination records in each municipality. The primary outcome was acute myocardial infarction (AMI) or stroke. The adjusted odds ratios (aORs) with 95% confidence intervals (CIs) for PPSV23 vaccination were calculated using conditional logistic regression. Among 383,781 individuals aged ≥ 65 years, 5,356 and 25,730 individuals with AMI or stroke were matched with 26,753 and 128,397 event-free controls, respectively. Individuals who were PPSV23 vaccinated, compared with the unvaccinated individuals, had significantly lower odds of AMI or stroke events (aOR, 0.70 [95% CI, 0.62-0.80] and aOR, 0.81 [95% CI, 0.77-0.86], respectively). More recent PPSV23 vaccination was associated with lower odds ratios (AMI, aOR 0.55 [95% CI, 0.42-0.72] for 1-180 days and aOR 1.11 [95% CI, 0.84-1.47] for 720 days or longer; stroke, aOR 0.83 [95% CI, 0.74-0.93] for 1-180 days and aOR 0.90 [95% CI, 0.78-1.03] for 720 days or longer). Among Japanese older adults, individuals who were PPSV23 vaccinated, compared with unvaccinated individuals, had significantly lower odds of AMI or stroke events.. |
| 4. |
Kiyomasa Nakatsuka, Rei Ono, Shunsuke Murata, Toshihiro Akisue, Haruhisa Fukuda, Claimed-based frailty index in Japanese older adults: a cohort study using LIFE Study., Journal of epidemiology, 10.2188/jea.JE20220310, 2023.03, BACKGROUNDS: We aimed to assess whether the U.S. developed claimed-based frailty index (CFI) can be implemented in Japanese older adults using claim data. METHODS: We used the monthly claims data and certification of long-term care (LTC) insurance data of residents from 12 municipalities from April 2014 to March 2019. The 12 months from first recording was defined as the "baseline period," and the time thereafter as "follow-up period". Participants aged ≥65 years and those with no certified LTC insurance or who died at baseline were included. New certification of LTC insurance and all-cause mortality during the follow-up period were defined as outcome events. CFI categorization consisted of three steps including: 1) using 12 months deficit-accumulation approach that assigned different weights to each of the 52 items; 2) the accumulated score to derive the CFI; and 3) categorizing the CFI as "robust" ( |
| 5. |
Both new-onset and pre-existing hypertension are favorable indicators of clinical outcomes in patients treated with vascular endothelial growth factor inhibitors.. |
| 6. |
Risk of cardiovascular events leading to hospitalization after Streptococcus pneumoniae infection: A retrospective cohort LIFE study.. |
| 7. |
The Effect of renin-angiotensin system inhibitors in cancer patients treated with anti-VEGF therapy.. |
| 8. |
Association between periodontal pocket depth determined during dental check-ups and new onset of diabetes in community residents: the LIFE study. |
| 9. |
Wataru Mimura, Chieko Ishiguro, Megumi Maeda, Fumiko Murata, Haruhisa Fukuda, Effectiveness of messenger RNA vaccines against infection with SARS-CoV-2 during the periods of Delta and Omicron variant predominance in Japan: the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) study, International Journal of Infectious Diseases, 10.1016/j.ijid.2022.10.001, 125, 58-60, 2022.12. |
| 10. |
Wataru Mimura, Chieko Ishiguro, Megumi Maeda, Fumiko Murata, Haruhisa Fukuda, Effectiveness of a Third Dose of COVID-19 mRNA Vaccine During the Omicron BA.1- and BA.2-Predominant Periods in Japan: The VENUS Study., Open forum infectious diseases, 10.1093/ofid/ofac636, 9, 12, ofac636, 2022.12, BACKGROUND: Vaccine effectiveness against the severe acute respiratory syndrome coronavirus 2 Omicron BA.2 sublineage in Japan is unknown. We assessed the effectiveness of a third dose of COVID-19 mRNA vaccine compared with that of 2 doses. METHODS: We performed a population-based cohort study using a municipality database located in the Chubu region of Japan during the Omicron BA.1- and BA.2-predominant periods (January 1-March 31, 2022 and April 1-27, 2022, respectively). We included residents aged ≥16 years who received a second vaccine dose at ≥14 days before the start of each period, regardless of the third dose. We compared the data at 14 days after the second and third dose and at 2-week intervals from 14 days to 10 weeks after the third dose using a Cox regression model. Vaccine effectiveness was defined as (1 - hazard ratio) × 100 (%). RESULTS: In total, 295 705 and 288 184 individuals were included in the BA.1- and BA.2-predominant periods, respectively. The effectiveness of a third dose against infection was 62.4% and 48.1% in the BA.1- and BA.2-predominant periods, respectively. Vaccine effectiveness at 2-3 weeks and ≥10 weeks after the third dose decreased from 63.6% (95% confidence interval [CI], 56.4-69.5%) to 52.9% (95% CI, 41.1-62.3%) and from 54.5% (95% CI, 3.0-78.7%) to 40.1% (95% CI, 15.1-57.7%) in the BA.1- and BA.2-predominant periods, respectively. CONCLUSIONS: A third dose was moderately effective against BA.1 and BA.2 sublineages, but its effectiveness decreased by approximately 10% age points from 2-3 weeks to ≥10 weeks after the third vaccination.. |
| 11. |
Mimura W, Ishiguro C, Fukuda H., Influenza vaccine effectiveness against hospitalization during the 2018/2019 season among older persons aged ≥75 years in Japan: LIFE-VENUS Study., Vaccine, 40, 34, 5023-5029, 2022.11. |
| 12. |
Ishiguro C, Mimura W, Murata F, Fukuda H., Development and Application of a Japanese Vaccine Database for Comparative Assessments in the Post-Authorization Phase: The Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study., Vaccine, 40, 42, 6179-6186, 2022.11. |
| 13. |
Adomi M, Maeda M, Murata F, Fukuda H., Comparative risk of fracture in community-dwelling older adults initiating suvorexant versus Z-drugs: Results from LIFE Study., Journal of the American Geriatrics Society, 10.1111/jgs.18068, in press, 2022.11. |
| 14. |
Fukuda H, Maeda M, Murata F, Murata Y., Anti-Dementia Drug Persistence Following Donepezil Initiation Among Alzheimer's Disease Patients in Japan: LIFE Study., Journal of Alzheimer's Disease, 10.3233/JAD-220200, in press, 2022.11. |
| 15. |
Mimura W, Ishiguro C, Maeda M, Murata F, Fukuda H., Effectiveness of mRNA vaccines against SARS-CoV-2 infections during the periods of Delta and Omicron variant predominance in Japan: The VENUS Study., International Journal of Infectious Disease, 10.1016/j.ijid.2022.10.001, in press, 2022.11. |
| 16. |
Nishimura N, Fukuda H., Risk of cardiovascular events leading to hospitalization after Streptococcus pneumoniae infection: A retrospective cohort LIFE study. BMJ Open, BMJ Open, in press, 2022.11. |
| 17. |
Comparative risk of fracture in community‐dwelling older adults initiating suvorexant versus Z‐drugs: results from LIFE study. |
| 18. |
Chieko Ishiguro, Wataru Mimura, Fumiko Murata, Haruhisa Fukuda, Development and application of a Japanese vaccine database for comparative assessments in the post-authorization phase: The Vaccine Effectiveness, Networking, and Universal Safety (VENUS) study., Vaccine, 10.1016/j.vaccine.2022.08.069, 2022.09. |
| 19. |
Wataru Mimura, Chieko Ishiguro, Haruhisa Fukuda, Influenza vaccine effectiveness against hospitalization during the 2018/2019 season among older persons aged ≥ 75 years in Japan: The LIFE-VENUS Study., Vaccine, 10.1016/j.vaccine.2022.07.002, 40, 34, 5023-5029, 2022.08. |
| 20. |
Medical visits and health-care expenditures of patients attending orthopedic clinics during the COVID-19 pandemic in Japan: LIFE Study
Abstract
Background
The first state of emergency for coronavirus disease 2019 (COVID-19) in Japan was imposed from April to May 2020. During that period, people were urged to avoid non-essential outings, which may have reduced their access to health care.
Methods
Using health-care claims data from a city in Fukuoka prefecture, Japan, we conducted a retrospective cohort study of the state of emergency’s impact on patients’ medical visits to orthopedic clinics and their associated health-care expenditures. These measures were compared between 2019 and 2020 using a year-over-year analysis and unpaired t-tests.
Results
The analysis showed that medical visits in 2020 significantly decreased by 23.7% in April (P < 0.01) and 17.6% in May (P < 0.01) when compared with the previous year. Similarly, monthly outpatient health-care expenditure significantly decreased by 2.4% (P < 0.01) in April 2020 when compared with April 2019. In contrast, the health-care expenditure per capita per visit significantly increased by 1.5% (P < 0.01) in June 2020 (after the state of emergency was lifted) when compared with June 2019.
Conclusion
As orthopedic clinics in Japan are reimbursed using a fee-for-service system, the increases in per capita expenditures after the state of emergency may be indicative of physician-induced demand. However, we posit that it is more likely that a post-emergency increase in anti-inflammatory and analgesic treatments for spondylopathies, low back pain and sciatica induced a temporary rise in these expenditures.. |
| 21. |
Fumiko Murata, Megumi Maeda, Chieko Ishiguro, Haruhisa Fukuda, Acute and delayed psychiatric sequelae among patients hospitalised with COVID-19: a cohort study using LIFE study data., General psychiatry, 10.1136/gpsych-2022-100802, 35, 3, e100802, 2022.06, Background: Characterising the psychiatric sequelae of coronavirus disease 2019 (COVID-19) can inform the development of long-term treatment strategies. However, few studies have examined these sequelae at different time points after COVID-19 infection. Aims: The study aimed to investigate the incidences and risks of acute and delayed psychiatric sequelae in patients hospitalised with COVID-19 in Japan. Methods: This retrospective cohort study was conducted using a database comprising healthcare claims data from public health insurance enrollees residing in a Japanese city. We analysed a primary cohort comprising patients hospitalised with COVID-19 between March 2020 and July 2021 and two control cohorts comprising patients hospitalised with influenza or other respiratory tract infections (RTI) during the same period. We calculated the incidences of acute (1-3 months after infection) and delayed (4-6 months after infection) psychiatric sequelae. These sequelae were identified using diagnosis codes and categorised as mood/anxiety/psychotic disorder, mood disorder, anxiety disorder, psychotic disorder or insomnia. Multivariable logistic regression models were used to estimate the odds ratios (ORs) of psychiatric sequelae occurrence after COVID-19 infection compared with influenza and other RTI. Results: The study population with acute psychiatric sequela consisted of 662 patients with COVID-19, 644 patients with influenza, and 7369 patients with RTI who could be followed for 3 months; the study population with delayed psychiatric sequelae consisted of 371 patients with COVID-19, 546 patients with influenza, and 5397 patients with RTI who could be followed for 6 months. In the analysis of acute psychiatric sequelae, COVID-19 had significantly higher odds of mood/anxiety/psychotic disorder (OR: 1.39, p=0.026), psychotic disorder (OR: 2.13, p |
| 22. |
Risk factors for pneumococcal disease in persons with chronic medical conditions: Results from the LIFE Study.. |
| 23. |
Tomokazu Shoji, Natsu Sato, Haruhisa Fukuda, Yuichi Muraki, Keishi Kawata, Manabu Akazawa, Clinical Implication of the Relationship between Antimicrobial Resistance and Infection Control Activities in Japanese Hospitals: A Principal Component Analysis-Based Cluster Analysis., Antibiotics (Basel, Switzerland), 10.3390/antibiotics11020229, 11, 2, 2022.02, There are few multicenter investigations regarding the relationship between antimicrobial resistance (AMR) and infection-control activities in Japanese hospitals. Hence, we aimed to identify Japanese hospital subgroups based on facility characteristics and infection-control activities. Moreover, we evaluated the relationship between AMR and hospital subgroups. We conducted a cross-sectional study using administrative claims data and antimicrobial susceptibility data in 124 hospitals from April 2016 to March 2017. Hospitals were classified using cluster analysis based the principal component analysis-transformed data. We assessed the relationship between each cluster and AMR using analysis of variance. Ten variables were selected and transformed into four principal components, and five clusters were identified. Cluster 5 had high infection control activity. Cluster 2 had partially lower activity of infection control than the other clusters. Clusters 3 and 4 had a higher rate of surgeries than Cluster 1. The methicillin-resistant Staphylococcus aureus (MRSA)/S. aureus detection rate was lowest in Cluster 1, followed, respectively, by Clusters 5, 2, 4, and 3. The MRSA/S. aureus detection rate differed significantly between Clusters 4 and 5 (p = 0.0046). Our findings suggest that aggressive examination practices are associated with low AMR whereas surgeries, an infection risk factor, are associated with high AMR.. |
| 24. |
Economic Status and Mortality in Patients with Alzheimer's Disease in Japan: The Longevity Improvement and Fair Evidence Study. |
| 25. |
Fukuda H, Ono R, Maeda M, Murata F, Medical care and long-term care expenditures attributable to Alzheimer's disease onset: Results from the LIFE Study., Journal of Alzheimer's Disease, 10.3233/JAD-201508, 84, 2, 807-817, 2021.11. |
| 26. |
Fukuda H, Changes to hospital inpatient volume after newspaper reporting of medical errors., Journal of Patient Safety, 17, 5, e401-e405, 2021.08. |
| 27. |
The background occurrence of selected clinical conditions prior to the start of an extensive national vaccination program in Japan
Introduction
The COVID-19 pandemic caused by SARS-CoV-2 has now affected tens of millions of people globally. It is the hope that vaccines against SARS-CoV-2 will deliver a comprehensive solution to this global pandemic; however, this will require extensive national vaccination programs. Ultimately, clinical conditions and even sudden unexplained death will occur around the time of vaccination, thus a distinction needs to be made between events that are causally related to the vaccine or temporally related to vaccination. This study aimed to estimate the background occurrence of 43 clinical conditions in the Japanese population.
Methods
A retrospective cohort study was conducted from 2013 to 2019 using data from two large healthcare claims databases (MDV and JMDC) in Japan. The estimated number of new cases and incidence were calculated based on the actual number of new cases identified in the databases. The PubMed and Ichushi-web databases, as well as grey literature such as guidelines and government statistics, were also searched to identify any publications related to incidence of these conditions in Japan.
Results and conclusion
The estimates of the number of total cases and incidence were similar for the MDV and JMDC databases for some diseases. In addition, some estimates were similar to those in the scientific literature. For example, from the MDV and JMDC databases, estimates of incidence of confirmed Bell’s palsy in 2019 were 41.7 and 47.9 cases per 100,000 population per year, respectively. These estimates were of the same order from the scientific publication. Determining whether clinical conditions occurring around the time of vaccination are causally or only temporally related to vaccination will be critical for public health decision makers as well as for the general public. Comparison of background occurrence at the population level may provide some additional objective evidence for the evaluation of temporality or causality.. |
| 28. |
National database study of trends in bacteraemia aetiology among children and adults in Japan: a longitudinal observational study.. |
| 29. |
Haruhisa Fukuda, Kosuke Kiyohara, Daisuke Sato, Tetsuhisa Kitamura, Satoshi Kodera, A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements: SAPIEN 3 Versus CoreValve Versus Evolut R, Value in Health, 10.1016/j.jval.2020.10.022, 24, 4, 497-504, 2020.12, OBJECTIVES: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data. METHODS: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes. RESULTS: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P |
| 30. |
Healthcare resources attributable to methicillin-resistant Staphylococcus aureus orthopedic surgical site infections.. |
| 31. |
Low-intensity pulsed ultrasound is frequently used to treat fractures after osteosynthesis in elderly patients: A study using open data from the National Database of Health Insurance Claims of Japan.. |
| 32. |
Shigemichi Takito, Yoshiki Kusama, Haruhisa Fukuda, Satoshi Kutsuna, Pharmacist-supported antimicrobial stewardship in a retirement home, Journal of Infection and Chemotherapy, 10.1016/j.jiac.2020.04.008, 26, 8, 858-861, 2020.08, In an 80-bed fee-based retirement home with nursing care, the dispatched-pharmacist has provided prescription recommendations to visiting physicians based on pathogen identification using Gram staining as part of an antimicrobial stewardship program. Thus, we evaluated the effects of pharmacist-supported antimicrobial stewardship. We calculated the total number of all antimicrobials and macrolides, fluoroquinolones, and cephalosporins prescriptions per 100 residents per month at the retirement home from January 2013 to December 2017. Using log-transformed monthly resident numbers with an offset before and after the intervention, we performed Poisson regression analyses that adjusted for monthly mean age. Interrupted time series analyses (ITSA) were conducted to examine the changes in the incidence rate ratios for the baseline and slope before and after the intervention. The total number of all antimicrobial prescriptions per 100 residents per month from 2013 to 2017 was 14.10, 18.51, 10.59, 5.41, and 3.90, respectively. Although there was a significant pre-intervention increase in the total number of all antimicrobial prescriptions, the intervention was followed by a significant decrease. There was also a significant reduction in the slope. ITSA of the changes in the prescription of macrolides and fluoroquinolones showed that there were significant pre-intervention increase and followed by a significant post-intervention decrease in the slope. There was no significant change in cephalosporin prescriptions by the intervention. Our study shows that pharmacist-supported AS can reduce antimicrobial prescriptions in a retirement home. Nevertheless, further studies are needed to collect and analyse more data on similar interventions.. |
| 33. |
The effects of raising the long‐term care insurance co‐payment rate on the utilization of long‐term care services. |
| 34. |
Comparing Retreatments and Expenditures in Flow Diversion Versus Coiling for Unruptured Intracranial Aneurysm Treatment: A Retrospective Cohort Study Using a Real-World National Database. |
| 35. |
Yugo Soga, Fumiko Murata, Megumi Maeda, Haruhisa Fukuda, The effects of raising the long-term care insurance co-payment rate on the utilization of long-term care services, Geriatrics and Gerontology International, 10.1111/ggi.13935, 20, 7, 685-690, 2020.07, Aim: The effect of raising insurance co-payment rates on healthcare service utilization in Japan remains unclear. In this study, we utilized patient-level long-term care (LTC) insurance claims data to analyze these effects. Methods: Claims data were obtained on individuals certified as requiring LTC in City A and City B, Fukuoka Prefecture, Japan during August 2014–July 2016. Individuals whose LTC insurance co-payment rate increased from 10% to 20% in August 2015 were regarded as high-income individuals; individuals whose co-payment rate remained at 10% were regarded as non–high-income individuals. We examined the changes in LTC service utilization between high-income individuals and non–high-income individuals during the study period. Monthly LTC insurance charges were analyzed to evaluate service utilization. We created monthly panel data for the study participants, and quantified the differences in LTC service utilization before and after August 2015 between the high-income and non–high-income groups. Care needs levels and age were included as covariates in a fixed-effects model. Results: The sample comprised 7711 individuals (1000 high-income individuals and 6711 non–high-income individuals) in City A and 647 individuals (84 high-income individuals and 563 non–high-income individuals) in City B. After adjusting for care needs levels and age, the co-payment rate increase was associated with reductions in monthly LTC insurance charges of $34.3 (P |
| 36. |
Shigemichi Takito, Yoshiki Kusama, Haruhisa Fukuda, Satoshi Kutsuna, Pharmacist-supported antimicrobial stewardship in a retirement home., Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 10.1016/j.jiac.2020.04.008, 26, 8, 858-861, 2020.04, In an 80-bed fee-based retirement home with nursing care, the dispatched-pharmacist has provided prescription recommendations to visiting physicians based on pathogen identification using Gram staining as part of an antimicrobial stewardship program. Thus, we evaluated the effects of pharmacist-supported antimicrobial stewardship. We calculated the total number of all antimicrobials and macrolides, fluoroquinolones, and cephalosporins prescriptions per 100 residents per month at the retirement home from January 2013 to December 2017. Using log-transformed monthly resident numbers with an offset before and after the intervention, we performed Poisson regression analyses that adjusted for monthly mean age. Interrupted time series analyses (ITSA) were conducted to examine the changes in the incidence rate ratios for the baseline and slope before and after the intervention. The total number of all antimicrobial prescriptions per 100 residents per month from 2013 to 2017 was 14.10, 18.51, 10.59, 5.41, and 3.90, respectively. Although there was a significant pre-intervention increase in the total number of all antimicrobial prescriptions, the intervention was followed by a significant decrease. There was also a significant reduction in the slope. ITSA of the changes in the prescription of macrolides and fluoroquinolones showed that there were significant pre-intervention increase and followed by a significant post-intervention decrease in the slope. There was no significant change in cephalosporin prescriptions by the intervention. Our study shows that pharmacist-supported AS can reduce antimicrobial prescriptions in a retirement home. Nevertheless, further studies are needed to collect and analyse more data on similar interventions.. |
| 37. |
Fumiko Murata, Akira Babazono, Haruhisa Fukuda, Effect of income on length of stay in a hospital or long-term care facility among older adults with dementia in Japan., International journal of geriatric psychiatry, 10.1002/gps.5248, 35, 3, 302-311, 2020.03, OBJECTIVE: We aimed to ascertain the degree of influence of income disparity among older people with newly developed dementia on the probability and duration of stay in a hospital or long-term care facility and the degree of influence on medical expenses for hospitalization and care costs. METHODS: This was a retrospective cohort study. Study participants included 12 829 individuals aged 75 years or older not diagnosed with dementia between April 2012 and March 2013 but newly diagnosed with dementia between April 2013 and March 2014. Participants were categorized according to income. We evaluated the associations of income with the probability and duration of stay in a hospital or long-term care facility and the costs for hospitalization and care. RESULTS: In the adjusted analyses, high-income individuals had a lower probability of admission to a hospital or long-term care facility than middle- and high-income individuals. In all hospitals, low-income individuals had the longest duration of stay, but in long-term care facilities, income categories varied by facility type. Medical expenses for hospitalization and care costs were highest in the low-income group. CONCLUSION: Income category affects the probability and duration of stay in the hospital or a long-term care facility, as well as expenses for hospitalization and care. It is necessary to consider a policy to enable low-income older patients with dementia to continue living at home.. |
| 38. |
Haruhisa Fukuda, Yoshihiko Yano, Daisuke Sato, Sachiko Ohde, Shinichi Noto, Ryo Watanabe, Osamu Takahashi, Healthcare Expenditures for the Treatment of Patients Infected with Hepatitis C Virus in Japan., PharmacoEconomics, 10.1007/s40273-019-00861-x, 38, 3, 297-306, 2020.03, AIM: The recently developed direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infections are costly. Cost-effectiveness analyses of DAAs require accurate healthcare expenditure estimates for the various HCV disease states, but few studies have produced such estimates using national-level data. This study utilized nationally representative data to estimate the healthcare expenditure for each HCV disease state. METHODS: We identified all patients infected with HCV between April 2010 and March 2018 from a nationwide administrative claims database in Japan. Monthly patient-level healthcare expenditures were calculated for the following disease states: chronic hepatitis C (CHC), compensated cirrhosis (CC), decompensated cirrhosis (DC), and hepatocellular carcinoma (HCC). The expenditures for the CHC and CC states were also compared before DAA treatment and after sustained virologic response (SVR) was achieved. A longitudinal two-part model was employed to estimate the healthcare expenditures for each state. RESULTS: During the study period, 1,564,043 patients with 146,488,137 patient-months of data met the inclusion criteria. The year of valuation was 2017. The mean monthly healthcare expenditures per patient (95% confidence intervals) for the pre-DAA CHC, CC, DC, and HCC states were US$267 (US$267-268), US$428 (US$427-429), US$666 (US$663-669), and US$969 (US$966-972), respectively. The mean monthly healthcare expenditures per patient for the post-SVR (≥ 2 years) CHC and CC states were US$176 (US$176-177) and US$238 (US$236-240), respectively. Healthcare expenditure increased with increasing age in all disease states (P |
| 39. |
Wataru Mimura, Haruhisa Fukuda, Manabu Akazawa, Antimicrobial Utilization and Antimicrobial Resistance in Patients With Haematological Malignancies in Japan: A Multi-Centre Cross-Sectional Study, Ann Clin Microbiol Antimicrob, 10.1186/s12941-020-00348-0, 19, 1, 7-7, 2020.02, BACKGROUND: Infection is a major complication for patients with haematological malignancies. It is important to better understand the use of antimicrobial agents and antibiotic resistance for appropriate treatment and prevention of drug resistance. However, very few multi-centre analyses have focused on the use of antimicrobial agents and antibiotic resistance have been carried out in Japan. This study aimed to describe the characteristics of the use of antimicrobial agents and antibiotic resistance in patients with haematological malignancies. METHODS: We conducted a cross-sectional study using administrative claims data and antimicrobial susceptibility data in Japan. We included patients diagnosed with haematological malignancies, who were hospitalized in a haematology ward between 1 April 2015 and 30 September 2017 in 37 hospitals. Descriptive statistics were used to summarize patient characteristics, antimicrobial utilization, bacterial infections, and antibiotic resistance. RESULTS: In total, 8064 patients were included. Non-Hodgkin lymphoma (50.0%) was the most common malignancy. The broad-spectrum antibiotics displayed a following antimicrobial use density (AUD): cefepime (156.7), carbapenems (104.8), and piperacillin/tazobactam (28.4). In particular, patients with lymphoid leukaemia, myeloid leukaemia, or myelodysplastic syndromes presented a higher AUD than those with Hodgkin lymphoma, non-Hodgkin lymphoma, or multiple myeloma. The most frequent bacterial species in our study cohort was Escherichia coli (9.4%), and this trend was also observed in blood specimens. Fluoroquinolone-resistant E. coli (3.6%) was the most frequently observed antibiotic-resistant strain, while other antibiotic-resistant strains were rare. CONCLUSIONS: Broad-spectrum antibiotics were common in patients with haematological malignancies in Japan; however, antibiotic-resistant bacteria including carbapenem-resistant or multidrug-resistant bacteria were infrequent. Our results provide nationwide, cross-sectional insight into the use of antimicrobial agents, prevalence of bacteria, and antibiotic resistance, demonstrating differences in antimicrobial utilization among different haematological diseases.. |
| 40. |
Longitudinal trends of and factors associated with inappropriate antibiotic prescribing for non-bacterial acute respiratory tract infection in Japan: A retrospective claims database study, 2012–2017. |
| 41. |
Chie Teramoto, Tatsuro Ishizaki, Seigo Mitsutake, Haruhisa Fukuda, Takashi Naruse, Sayuri Shimizu, Hideki Ito, Impact of a national medical fee schedule revision on the cessation of physician home visits among older patients in Tokyo: A retrospective study., Health & social care in the community, 10.1111/hsc.12707, 27, 4, 899-906, 2019.07, As Japan's population continues to age rapidly, the national government has implemented several measures to improve the efficiency of healthcare services and to control rising medical expenses for older patients. One such measure was the revision of the medical fee schedule for physician home visits in April 2014, in which eligibility for these visits was restricted to patients who are unable to visit outpatient clinics without assistance. Through an investigation of patients who were receiving physician home visits in Tokyo, this study examines whether this fee schedule revision resulted in an increase in patients who transitioned from home visits to outpatient care. In a retrospective analysis of health insurance claims data, we examined 80,914 Tokyo residents aged 75 years or older who had received at least one physician home visit between January and May 2014. The study period was divided into four periods (January-February, February-March, March-April, and April-May), and we examined the number of patients receiving home visits in the index month of each period who subsequently transitioned to outpatient care in the following month. Potential factors associated with this transition to outpatient care were examined using a generalised estimating equation. The March-April period that included the fee schedule revision was significantly associated with a higher number of patients who transitioned from home visits in the index month to outpatient care in the following month (odds ratio: 4.46, p |
| 42. |
A comparative analysis of treatment costs for home-based care and hospital-based care in enteral nutrition patients: A retrospective analysis of claims data. |
| 43. |
Cost-effectiveness of implementing guidelines for the treatment of glucocorticoid-induced osteoporosis in Japan. |
| 44. |
Fukuda H, Yano T, Shimono N, Inpatient expenditures attributable to hospital-onset Clostridium difficile infection: a nationwide case-control study in Japan., PharmacoEconomics, 36, 11, 1367-1376, 2018.11. |
| 45. |
Hirose Masahiro, Nishimura Nobuhiro, Kumakura Shiyunichi, Telloyan John Arthur, Igawa Mikio, Fukuda Haruhisa, Imanaka Yuichi, Do pharmacists have the most potential for patient safety in Japan? Learning from a 2010 nationwide survey, Journal of Hospital Administration, 7, 3, 40-48, 2018.04, Background: Unlike in many other countries, patient safety (PS) in Japan has been promoted under the social insurance medical fee schedule, with the implementation of preferential medical fee paid to medical institutions as incentives. Meanwhile, many hospitals do not assign a full-time physician as PS manager at PS division due to the shortage of physicians.Objective: The Health Ministry in Japan has been promoting PS by utilizing the preferential patient safety countermeasure fee (PPSCF) since 2006. This study aims to address the potential of pharmacists for PS at hospitals implementing the PPSCF.Methods: A nationwide questionnaire survey targeting 2,674 hospitals with the PPSCF was performed from 2010 to 2011. Of the 669 hospitals that responded, 627 hospitals were eligible for analysis, including 178 hospitals implementing PPSCF 1 with 400 beds or more (group A), 286 hospitals implementing PPSCF 1 with 399 beds or fewer (group B), and 163 hospitals implementing PPSCF 2 (group C).Results: Although the mean values of PS activities for nurses were the highest among physicians, nurses, and pharmacists, the values per person recalculated for pharmacists were the highest, and the ranges of the values per person for pharmacists were narrowest across the three professional groups. For example, the number per person of incident reports filed in group A was 2.37 ± 0.30 for pharmacists, 1.14 ± 0.11 for physicians, and 2.09 ± 0.31 for nurses (p = .002). For pharmacists, those values were 2.37 ± 0.30 in group A, 2.43 ± 0.14 in group B and 2.35 ± 0.19 in group C (p = .802).Conclusions: Across health professionals, pharmacists may have the most potential for PS under the social insurance medical fee schedule in Japan.. |
| 46. |
Effects of changes in eating speed on obesity in patients with diabetes: a secondary analysis of longitudinal health check-up data
Objective
Few studies have examined the causal relationships between lifestyle habits and obesity. With a focus on eating speed in patients with type 2 diabetes, this study aimed to analyse the effects of changes in lifestyle habits on changes in obesity using panel data.
Methods
Patient-level panel data from 2008 to 2013 were generated using commercially available insurance claims data and health check-up data. The study subjects comprised Japanese men and women (n=59 717) enrolled in health insurance societies who had been diagnosed with type 2 diabetes during the study period. Body mass index (BMI) was measured, and obesity was defined as a BMI of 25 or more. Information on lifestyle habits were obtained from the subjects’ responses to questions asked during health check-ups. The main exposure of interest was eating speed (‘fast’, ‘normal’ and ‘slow’). Other lifestyle habits included eating dinner within 2 hours of sleeping, after-dinner snacking, skipping breakfast, alcohol consumption frequency, sleep adequacy and tobacco consumption. A generalised estimating equation model was used to examine the effects of these habits on obesity. In addition, fixed-effects models were used to assess these effects on BMI and waist circumference.
Results
The generalised estimating equation model showed that eating slower inhibited the development of obesity. The ORs for slow (0.58) and normal-speed eaters (0.71) indicated that these groups were less likely to be obese than fast eaters (P
Discussion
Changes in eating speed can affect changes in obesity, BMI and waist circumference. Interventions aimed at reducing eating speed may be effective in preventing obesity and lowering the associated health risks.. |
| 47. |
Koki Kato, Haruhisa Fukuda, Comparative economic evaluation of home-based and hospital-based palliative care for terminal cancer patients, GERIATRICS & GERONTOLOGY INTERNATIONAL, 10.1111/ggi.12977, 17, 11, 2247-2254, 2017.11, AimTo quantify the difference between adjusted costs for home-based palliative care and hospital-based palliative care in terminally ill cancer patients.
MethodsWe carried out a case-control study of home-care patients (cases) who had died at home between January 2009 and December 2013, and hospital-care patients (controls) who had died at a hospital between April 2008 and December 2013. Data on patient characteristics were obtained from insurance claims data and medical records. We identified the determinants of home care using a multivariate logistic regression analysis. Cox proportional hazards analysis was used to examine treatment duration in both types of care, and a generalized linear model was used to estimate the reduction in treatment costs associated with home care.
ResultsThe case and control groups comprised 48 and 99 patients, respectively. Home care was associated with one or more person(s) living with the patient (adjusted OR 6.54, 95% CI 1.18-36.05), required assistance for activities of daily living (adjusted OR 3.61, 95% CI 1.12-10.51), non-use of oxygen inhalation therapy (adjusted OR 12.75, 95% CI 3.53-46.02), oral or suppository opioid use (adjusted OR 5.74, 95% CI 1.11-29.54) and transdermal patch opioid use (adjusted OR 8.30, 95% CI 1.97-34.93). The adjusted hazard ratio of home care for treatment duration was not significant (adjusted OR 0.95, 95% CI 0.59-1.53). However, home care was significantly associated with a reduction of $7523 (95% CI $7093-7991, P = 0.015) in treatment costs.
ConclusionsDespite similar treatment durations between the groups, treatment costs were substantially lower in the home-care group. These findings might inform the policymaking process for improving the home-care support system. Geriatr Gerontol Int 2017; 17: 2247-2254.. |
| 48. |
Tatsuro Ishizaki, Masaya Shimmei, Haruhisa Fukuda, Eun-Hwan Oh, Chiho Shimada, Tomoko Wakui, Hiroko Mori, Ryutaro Takahashi, Cumulative number of hospital bed days among older adults in the last year of life: A retrospective cohort study, GERIATRICS & GERONTOLOGY INTERNATIONAL, 10.1111/ggi.12777, 17, 5, 737-743, 2017.05, Aim: To determine whether age, proximity to death and long-term care insurance certification are related to receiving hospital inpatient care; the number of hospital bed days (HBD) among older Japanese adults in the last year of life; and to estimate the total number of HBD.
Methods: Using health insurance claims and death certificate data, the present retrospective cohort study examined the HBD of city residents aged >= 65 years who died between September 2006 and October 2009 in Soma City, Japan. Using a two-part model, factors associated with receiving hospital inpatient care and the total number of HBD in each quarter in the last year of life were examined.
Results: The total number of HBD in the last year of life varied widely; 13% had no admission, and 27% stayed >= 90 days. Younger age, approaching death and having long-term care insurance certification were significantly associated with being more likely to receive hospital inpatient care during each quarterly period in the last year of life. In contrast, having long-term care insurance certification and the last 3-month period before death, compared with the first 3-month period, were significantly associated with a fewer number of HBD.
Conclusions: The present study showed that older age was associated with being less likely to receive hospital inpatient care. The findings regarding the risk of inpatient care and total number of HBD in the last year of life help to understand resource use among older dying adults, and to develop evidence-based healthcare policies within aging societies.. |
| 49. |
Haruhisa Fukuda, Miki Mizobe, Impact of nonadherence on complication risks and healthcare costs in patients newly-diagnosed with, DIABETES RESEARCH AND CLINICAL PRACTICE, 10.1016/j.diabres.2016.11.007, 123, 55-62, 2017.01, Aims: To investigate the association between nonadherence to diabetes treatment and the occurrence of diabetes complications.
Methods: Our study retrospectively identified adherence and nonadherence to diabetes treatment in patients during the first year of observation after new diagnoses of type 2 diabetes enrolled in commercial database from 52 health insurers in Japan. Participants were insurance enrollees with type 2 diabetes who received healthcare between 2005 and 2013, and who could be tracked for more than 12 months from the initiation of diabetes treatment. We compared the occurrence of diabetes-related complications (retinopathy, nephropathy, neuropathy, ischemic heart disease, cerebrovascular disease, and chronic arterial occlusion) and all-cause healthcare expenditure during the second to eighth years.
Results: We identified 1784 nonadherent patients and 9547 adherent patients. Cox proportional hazard models showed that the occurrence of microvascular complications was significantly higher in the nonadherent group: the hazard ratios (95% confidence intervals) for retinopathy, nephropathy, and neuropathy were 2.04 (1.57-2.66), 1.91 (1.35-2.72), and 1.83 (1.02-3.27), respectively. However, no significant differences were observed between the adherent and nonadherent groups for the macrovascular complications (ischemic heart disease, cerebrovascular disease, and chronic arterial occlusion). In addition, the nonadherent group had a significantly higher cumulative healthcare expenditure than the adherent group during the second-to-fifth-year period (p = 0.029) and the second-to-sixth-year period (p = 0.009) after treatment initiation.
Conclusions: Nonadherence in the first year of diabetes may increase the incidence of complications and result in higher expenditures for patients and payers. (C) 2016 Elsevier Ireland Ltd. All rights reserved.. |
| 50. |
Haruhisa Fukuda, Shunya Ikeda, Takeru Shiroiwa, Takashi Fukuda, The Effects of Diagnostic Definitions in Claims Data on Healthcare Cost Estimates: Evidence from a Large-Scale Panel Data Analysis of Diabetes Care in Japan, PHARMACOECONOMICS, 10.1007/s40273-016-0402-3, 34, 10, 1005-1014, 2016.10, Background Inaccurate estimates of diabetes-related healthcare costs can undermine the efficiency of resource allocation for diabetes care. The quantification of these costs using claims data may be affected by the method for defining diagnoses.
Objectives The aims were to use panel data analysis to estimate diabetes-related healthcare costs and to comparatively evaluate the effects of diagnostic definitions on cost estimates.
Research design Monthly panel data analysis of Japanese claims data.
Subjects The study included a maximum of 141,673 patients with type 2 diabetes who received treatment between 2005 and 2013.
Measures Additional healthcare costs associated with diabetes and diabetes-related complications were estimated for various diagnostic definition methods using fixed-effects panel data regression models.
Results The average follow-up period per patient ranged from 49.4 to 52.3 months. The number of patients identified as having type 2 diabetes varied widely among the diagnostic definition methods, ranging from 14,743 patients to 141,673 patients. The fixed-effects models showed that the additional costs per patient per month associated with diabetes ranged from US$180 [95 % confidence interval (CI) 178-181] to US$223 (95 % CI 221-224). When the diagnostic definition excluded rule-out diagnoses, the diabetes-related complications associated with higher additional healthcare costs were ischemic heart disease with surgery (US$13,595; 95 % CI 13,568-13,622), neuropathy/extremity disease with surgery (US$4594; 95 % CI 3979-5208), and diabetic nephropathy with dialysis (US$3689; 95 % CI 3667-3711).
Conclusions Diabetes-related healthcare costs are sensitive to diagnostic definition methods. Determining appropriate diagnostic definitions can further advance healthcare cost research for diabetes and its applications in healthcare policies.. |
| 51. |
Haruhisa Fukuda, Kensuke Moriwaki, Cost-Effectiveness Analysis of Safety-Engineered Devices, INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY, 10.1017/ice.2016.110, 37, 9, 1012-1021, 2016.09, OBJECTIVE. To estimate the cost-effectiveness of safety-engineered devices (SEDs) relative to non-SEDs for winged steel needles, intravenous catheter stylets, suture needles, and insulin pen needles.
DESIGN. Decision analysis modeling.
PARTICIPANTS. Hypothetical cohort of healthcare workers who utilized needle devices.
METHODS. We developed a decision-analytic model to estimate and compare the life-cycle costs and benefits for SED and non-SED needle devices. For this cost-effectiveness analysis, we quantified the total direct medical cost per needlestick injury, number of needlestick injuries avoided, and incremental cost-effectiveness ratio. Sensitivity analyses were performed to examine the robustness of the base-case analysis.
RESULTS. In the base-case analysis, we calculated the incremental cost-effectiveness ratios of SED winged steel needles, intravenous catheter stylets, suture needles, and insulin pen needles to be $2,633, $13,943, $1,792, and $1,269 per needlestick injury avoided, respectively. Sensitivity analyses showed that the calculated incremental cost-effectiveness ratio values for using SEDs did not fall below zero even after adjusting the values of each parameter.
CONCLUSION. The use of SED needle devices would not produce cost savings for hospitals. Government intervention may be needed to systematically protect healthcare workers in Japan from the risk of bloodborne pathogen infections.. |
| 52. |
Kazunori Toyoda, Ken Okumura, Yoichiro Hashimoto, Takanori Ikeda, Takashi Komatsu, Teruyuki Hirano, Haruhisa Fukuda, Kazuo Matsumoto, Masahiro Yasaka, Identification of Covert Atrial Fibrillation in Cryptogenic Ischemic Stroke: Current Clinical Practice in Japan, JOURNAL OF STROKE & CEREBROVASCULAR DISEASES, 10.1016/j.jstrokecerebrovasdis.2016.05.012, 25, 8, 1829-1837, 2016.08, Background and aim: A new insertable cardiac monitor, Reveal LINQ (Medtronic, Dublin, Ireland), was approved for clinical use in Japan in March 2016 for detecting atrial fibrillation in patients who develop ischemic stroke with no clearly definable etiology even after extensive workup, so-called cryptogenic ischemic stroke. Cooperation between a specialist of the Japan Stroke Society and a trained cardiologist or cardiac surgeon is needed both for appropriate patient selection and appropriate management of the device. In this paper, the clinical significance of and diagnostic methods for cryptogenic stroke and covert atrial fibrillation are explained, along with our proposal for the clinical indications for this new device. Methods, results, and conclusion: The majority of cryptogenic ischemic strokes are considered to be embolic. In particular, covert atrial fibrillation is drawing attention as the causal emboligenic disease, and it was identified in 30% of patients with long-term observation using an insertable cardiac monitor. Should atrial fibrillation be present, there is a high risk of recurrent stroke, and the cardioembolic stroke that appears is generally severe. The ability to identify atrial fibrillation would be beneficial for preventing stroke recurrence, as anticoagulants can then be used as an established method of secondary prevention. Because the use of insertable cardiac monitors is somewhat invasive, and long-term care systems are also needed, patients suitable for examination using the new device would need to be identified on the basis of detailed diagnostics in accordance with current medical practice in Japan.. |
| 53. |
H. Fukuda, Patient-related risk factors for surgical site infection following eight types of gastrointestinal surgery, JOURNAL OF HOSPITAL INFECTION, 10.1016/j.jhin.2016.04.005, 93, 4, 347-354, 2016.08, Objective: To identify patient-related risk factors for surgical site infection (SSI) following eight types of gastrointestinal surgery that could be collected as part of infection surveillance efforts.
Design: Record linkage from existing datasets comprising the Japan Nosocomial Infections Surveillance (JANIS) and Diagnosis Procedure Combination (DPC) programmes.
Methods: Patient data from 35 hospitals were retrieved using JANIS and DPC from 2007 to 2011. Patient-related factors and the incidence of SSI were recorded and analysed. Risk factors associated with SSI were examined using multi-level mixed-effects logistic regression models.
Results: In total, 2074 appendectomies; 2084 bile duct, liver or pancreatic procedures; 3460 cholecystectomies; 7273 colonic procedures; 482 oesophageal procedures; 4748 gastric procedures; 2762 rectal procedures and 1202 small bowel procedures were analysed. Using multi-variate analyses, intra-operative blood transfusion was found to be a risk factor for SSI following all types of gastrointestinal surgery, except appendectomy and small bowel surgery. In addition, diabetes was found to be a risk factor for SSI following colon surgery [odds ratio (OR) 1.23, P = 0.028] and gastric surgery (OR 1.70, P Conclusions: Intra-operative blood transfusion, diabetes and use of steroids are risk factors for SSI following gastrointestinal surgery, and should be included as part of SSI surveillance for these procedures. (C) 2016 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.. |
| 54. |
Quantifying Additional Healthcare Resource Consumption Associated with MRSA Infection
This study tried to quantify the additional healthcare resources (indicated by length of hospital stay and healthcare expenditure) consumed by MRSA infections. The study included patients who had been discharged from our hospital (a 380–bed tertiary hospital) between December 2012 and December 2014. The database for analysis involved the combination of 2 administrative datasets: JANIS infection surveillance data for all admissions, and data from a government survey on the post-implementation effects of the diagnosis procedure combination system. The data were analyzed through propensity score matching. Propensity scores were estimated using a logistic regression model in which the independent variable was a dichotomous MRSA infection variable (1: infected; 0: uninfected). Using the propensity score, 1:1 matching was performed between cases (MRSA infection) and controls (no MRSA infection). The data was also analyzed using another matching method that addressed time-dependent bias. The additional healthcare resources associated with MRSA infections were calculated from the differences in the mean quantities of resources consumed between cases and controls. The total of 24,538 patients in the study included 47 identified as MRSA-infected patients. Including time-dependent bias, infected patients were associated with an additional length of stay of 13.1 days (95% confidence intervals [CI] 3.7–22.4, p=0.008) and an additional incremental healthcare cost of 1.07 million yen (95% CI 0.317–1.822, p=0.007). Excluding time-dependent bias, the additional length of stay was 21.2 days (95% CI 11.7–30.8, p. |
| 55. |
Cryptogenic ischemic stroke and embolic stroke of undetermined source: clinical implications and importance for detection of covert atrial fibrillation in Japan
Cryptogenic ischemic stroke, stroke with no clear definable cause even after extensive workup, does not have fixed diagnostic criteria. Proportion of this type of stroke among overall ischemic stroke varies much, ranging from 16% to 39%. Majority of cryptogenic ischemic stroke is considered as embolism, and the concept of embolic stroke of undetermined source has been recently proposed. In particular, covert atrial fibrillation is drawing attention, and it was identified in 30% of patients in long-term observation using an insertable cardiac monitor. A next-generation insertable cardiac monitor is small and has the capability of remote monitoring. Thus, it has been in clinical use to detect atrial fibrillation in patients with cryptogenic ischemic stroke in the United States, Europe, and Australia. If atrial fibrillation would be identified, anticoagulants can be legally used for prevention of stroke recurrence, and could reduce its recurrence in patients with cryptogenic ischemic stroke. A request has been submitted by the Japan Stroke Society to the Ministry of Health, Labor and Welfare, Japan, indicating the high medical needs of the next-generation insertable cardiac monitor to detect covert atrial fibrillation after cryptogenic ischemic stroke. If the use of the device is approved, patients appropriate for the use should be selected based on detailed examination including head MRI in accordance with the current situation of medical practice in Japan.. |
| 56. |
Haruhisa Fukuda, Cost-effectiveness analysis for diabetes care, Nippon rinsho. Japanese journal of clinical medicine, 74, 707-712, 2016.04. |
| 57. |
Haruhisa Fukuda, Manabu Kuroki, The Development of Statistical Models for Predicting Surgical Site Infections in Japan: Toward a Statistical Model-Based Standardized Infection Ratio, INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY, 10.1017/ice.2015.302, 37, 3, 260-271, 2016.03, OBJECTIVE. To develop and internally validate a surgical site infection (SSI) prediction model for Japan.
DESIGN. Retrospective observational cohort study.
METHODS. We analyzed surveillance data submitted to the Japan Nosocomial Infections Surveillance system for patients who had undergone target surgical procedures from January 1, 2010, through December 31, 2012. Logistic regression analyses were used to develop statistical models for predicting SSIs. An SSI prediction model was constructed for each of the procedure categories by statistically selecting the appropriate risk factors from among the collected surveillance data and determining their optimal categorization. Standard bootstrapping techniques were applied to assess potential overfitting. The C-index was used to compare the predictive performances of the new statistical models with those of models based on conventional risk index variables.
RESULTS. The study sample comprised 349,987 cases from 428 participant hospitals throughout Japan, and the overall SSI incidence was 7.0%. The C-indices of the new statistical models were significantly higher than those of the conventional risk index models in 21 (67.7%) of the 31 procedure categories (P<.05 no significant overfitting was detected.>CONCLUSIONS. Japan-specific SSI prediction models were shown to generally have higher accuracy than conventional risk index models. These new models may have applications in assessing hospital performance and identifying high-risk patients in specific procedure categories.. |
| 58. |
H. Fukuda, N. Yamanaka, Reducing needlestick injuries through safety-engineered devices: results of a Japanese multi-centre study, JOURNAL OF HOSPITAL INFECTION, 10.1016/j.jhin.2015.09.019, 92, 2, 147-153, 2016.02, Background: Quantitative information on the effectiveness of safety-engineered devices (SEDs) is needed to support decisions regarding their implementation.
Aim: To elucidate the effects of SED use in winged steel needles, intravenous (IV) catheter stylets and suture needles on needlestick injury (NSI) incidence rates in Japan.
Methods: Japan EPINet survey data and device utilization data for conventional devices and SEDs were collected from 26 participating hospitals between 1 April 2009 and 31 March 2014. The NSI incidence rate for every 100,000 devices was calculated according to hospital, year and SED use for winged steel needles, IV catheter stylets and suture needles. Weighted means and 95% confidence intervals (CI) were used to calculate overall NSI incidence rates.
Findings: In total, there were 236 NSIs for winged steel needles, 152 NSIs for IV catheter stylets and 180 NSIs for suture needles. The weighted NSI incidence rates per 100,000 devices for SEDs and non-SEDs were as follows: winged steel needles, 2.10 (95% CI 1.66-2.54) and 14.95 (95% CI 2.46-27.43), respectively; IV catheter stylets, 0.95 (95% CI 0.60-1.29) and 6.39 (95% CI 3.56-9.23), respectively; and suture needles, 1.47 (95% CI -1.14-4.09) and 16.50 (95% CI 4.15-28.86), respectively. All devices showed a significant reduction in the NSI incidence rate with SED use (P Conclusion: SED use substantially reduces the incidence of NSIs, and is therefore recommended as a means to prevent occupational infections in healthcare workers and improve healthcare safety. (C) 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.. |
| 59. |
Haruhisa Fukuda, Sayuri Shimizu, Tatsuro Ishizaki, Has the Reform of the Japanese Healthcare Provision System Improved the Value in Healthcare? A Cost-Consequence Analysis of Organized Care for Hip Fracture Patients, PLOS ONE, 10.1371/journal.pone.0133694, 10, 7, e0133694, 2015.07, Objectives
To assess the value of organized care by comparing the clinical outcomes and healthcare expenditure between the conventional Japanese "integrated care across specialties within one hospital" mode of providing healthcare and the prospective approach of "organized care across separate facilities within a community".
Design
Retrospective cohort study.
Setting
Two groups of hospitals were categorized according to healthcare delivery approach: the first group included 3 hospitals autonomously providing integrated care across specialties, and the second group included 4 acute care hospitals and 7 rehabilitative care hospitals providing organized care across separate facilities.
Participants
Patients aged 65 years and above who had undergone hip fracture surgery.
Measurements
Regression models adjusting for patient characteristics and clinical variables were used to investigate the impact of organized care on the improvements to the mobility capability of patients before and after hospitalization and the differences in healthcare resource utilization.
Results
The sample for analysis included 837 hip fracture surgery cases. The proportion of patients with either unchanged or improved mobility capability was not statistically associated with the healthcare delivery approaches. Total adjusted mean healthcare expenditure for integrated care and organized care were US$28,360 (95% confidence interval: 27,787-28,972) and US$21,951 (21,511-22,420), respectively, indicating an average increase of US$6,409 in organized care.
Conclusion
Our cost-consequence analysis underscores the need to further investigate the actual contribution of organized care to the provision of efficient and high-quality healthcare.. |
| 60. |
Increased Burden on Medical Resources of Penicillin-Resistant Streptococcus Pneumoniae Infections: Estimates Using JANIS Data
Drug-resistant bacterial infections in patients can aggravate disease conditions and prolong treatment durations, resulting in increased use of medical resources, and hinder measures aimed at moderating already strained health care costs. This study quantitatively estimated the additional medical resources used for drug-resistant bacterial infections, focusing on cases with penicillin-resistant Streptococcus pneumoniae (PRSP) infections judged by the Japan Nosocomial Infection Surveillance (JANIS). JANIS data and Diagnosis Procedure Combination/Per-Diem Payment System data were analyzed. The JANIS program collects data directly from voluntarily participating hospitals. The patients with PRSP infection were defined by the JANIS data. All subjects were categorized based on their diseases and surgical procedures as recorded in the data. Pairs of subjects with and without PRSP infections in each category were then matched according to a propensity score. To investigate the additional medical resources used due to PRSP infections, the differences in mean length of stay (LOS) and hospitalization costs were calculated between the matched pairs. The results showed that among all subjects, patients with PRSP infections had a mean LOS duration that was 2.79 days longer than uninfected patients. For patients under 5 years of age, PRSP infections resulted in an increase of 2.08 days in LOS and an additional 110,634 yen in hospitalization costs. This study presents a quantitative estimate of additional medical resources used due to PRSP infections. These drug-resistant bacterial infections resulted in clear increases in LOS among all patients, as well as increases in LOS and hospitalization costs in patients under 5 years of age. These findings have wide potential applications and can support technical assessments for infection control based on cost effectiveness. Comprehensive infection control measures that target drug-resistant bacterial infections are expected to be further developed.
. |
| 61. |
The effect of counter-referral of outpatients on the subsequent admission rate
Laying stress on the referral system is expected to promote functional differentiation. However, reduction in outpatient hospital services, which also enables functional differentiation, has not progressed. The purpose of this study was to identify the problems in, and factors influencing counter-referral for functional differentiation and to clarify the relationship between counter-referral, which is considered to affect policy making on reduction of outpatient services, and the subsequent admission rate. Data of patients with chronic obstructive pulmonary disease （COPD） or asthma who returned to the outpatient clinic of the Department of Respiratory Medicine, Nanpuh Hospital, were analyzed using a logistic regression model. Admission rates were compared by survival time analysis using propensity score matching. The analyses revealed that factors such as long-term prescription and outpatient visits to multiple departments were associated with increased counter-referral. In addition, comparison of the admission rates by survival time analysis showed no relationship between the counter-referral of outpatients and reduction in the subsequent admission rate. Thus, promotion of counter-referral of outpatients for reduction in general outpatient services may be expected to lead to functional differentiation of regional medical care in outpatient medical services.. |
| 62. |
Ryu Matsuo, Masahiro Kamouchi, Haruhisa Fukuda, Jun Hata, Yoshinobu Wakisaka, Junya Kuroda, Tetsuro Ago, Takanari Kitazono, Intravenous Thrombolysis with Recombinant Tissue Plasminogen Activator for Ischemic Stroke Patients over 80 Years Old: The Fukuoka Stroke Registry, PLOS ONE, 10.1371/journal.pone.0110444, 9, 10, e110444., 2014.10, Objectives: The benefit of intravenous recombinant tissue plasminogen activator (rt-PA) therapy for very old patients with acute ischemic stroke remains unclear. The aim of this study was to elucidate the efficacy and safety of intravenous rt-PA therapy for patients over 80 years old.
Methods: Of 13,521 stroke patients registered in the Fukuoka Stroke Registry in Japan from June 1999 to February 2013, 953 ischemic stroke patients who were over 80 years old, hospitalized within 3 h of onset, and not treated with endovascular therapy were included in this study. Among them, 153 patients were treated with intravenous rt-PA (0.6 mg/kg). For propensity score (PS)-matched case-control analysis, 148 patients treated with rt-PA and 148 PS-matched patients without rt-PA therapy were selected by 1:1 matching with propensity for using rt-PA. Clinical outcomes were neurological improvement, good functional outcome at discharge, in-hospital mortality, and hemorrhagic complications (any intracranial hemorrhage [ICH], symptomatic ICH, and gastrointestinal bleeding).
Results: In the full cohort of 953 patients, rt-PA use was associated positively with neurological improvement and good functional outcome, and negatively with in-hospital mortality after adjustment for multiple confounding factors. In PS-matched case-control analysis, patients treated with rt-PA were still at lower risk for unfavorable clinical outcomes than non-treated patients (neurological improvement, odds ratio 2.67, 95% confidence interval 1.61-4.40; good functional outcome, odds ratio 2.23, 95% confidence interval 1.16-4.29; in-hospital mortality, odds ratio 0.30, 95% confidence interval 0.13-0.65). There was no significant association between rt-PA use and risk of hemorrhagic complications in the full and PS-matched cohorts.
Conclusions: Intravenous rt-PA therapy was associated with improved clinical outcomes without significant increase in risk of hemorrhagic complications in very old patients (aged. 80 years) with acute ischemic stroke.. |
| 63. |
Haruhisa Fukuda, Kazuhide Okuma, Yuichi Imanaka, Can Experience Improve Hospital Management?, PLOS ONE, 10.1371/journal.pone.0106884, 9, 9, e106884, 2014.09, Background: Experience curve effects were first observed in the industrial arena as demonstrations of the relationship between experience and efficiency. These relationships were largely determined by improvements in management efficiency and quality of care. In the health care industry, volume-outcome relationships have been established with respect to quality of care improvement, but little is known about the effects of experience on management efficiency. Here, we examine the relationship between experience and hospital management in Japanese hospitals.
Methods: The study sample comprised individuals who had undergone surgery for unruptured abdominal aortic aneurysms and had been discharged from participant hospitals between April 1, 2006 and December 31, 2008. We analyzed the association between case volume (both at the hospital and surgeon level) and postoperative complications using multilevel logistic regression analysis. Multilevel log-linear regression analyses were performed to investigate the associations between case volume and length of stay (LOS) before and after surgery.
Results: We analyzed 909 patients and 849 patients using the hospital-level and surgeon-level analytical models, respectively. The odds ratio of postoperative complication occurrence for an increase of one surgery annually was 0.981 (PConclusion: Experience at the hospital level may contribute to the improvement of hospital management efficiency.. |
| 64. |
Guideline for economic evaluation of healthcare technologies in Japan. |
| 65. |
Haruhisa Fukuda, Keita Morikane, Manabu Kuroki, Shinichiro Taniguchi, Takashi Shinzato, Fumie Sakamoto, Kunihiko Okada, Hiroshi Matsukawa, Yuko Ieiri, Kouji Hayashi, Shin Kawai, Toward the rational use of standardized infection ratios to benchmark surgical site infections, AMERICAN JOURNAL OF INFECTION CONTROL, 10.1016/j.ajic.2012.10.004, 41, 9, 810-814, 2013.09, Background: The National Healthcare Safety Network transitioned from surgical site infection (SSI) rates to the standardized infection ratio (SIR) calculated by statistical models that included perioperative factors (surgical approach and surgery duration). Rationally, however, only patient-related variables should be included in the SIR model.
Methods: Logistic regression was performed to predict expected SSI rate in 2 models that included or excluded perioperative factors. Observed and expected SSI rates were used to calculate the SIR for each participating hospital. The difference of SIR in each model was then evaluated.
Results: Surveillance data were collected from a total of 1,530 colon surgery patients and 185 SSIs. C-index in the model with perioperative factors was statistically greater than that in the model including patient-related factors only (0.701 vs 0.621, respectively, P Conclusion: Because surgical approach and duration of surgery each serve as a partial proxy of the operative process or the competence of surgical teams, these factors should not be considered predictive variables. Copyright (c) 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.. |
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Haruhisa Fukuda, Assessment of Methodology to Compare Surgical-Site Infection Rates Across Institutions
A Nationwide Multi-Center Study Using JANIS Data, Japanese Journal of Environmental Infections, 10.4058/jsei.28.63, 28, 2, 63-73, 2013.01, Comparison of surgical site infection (SSI) rates across institutions has been an effective infection control measure, but success relies on the quality of risk adjustments. This study assessed desirable risk-adjustment methodologies for use in the Japan Nosocomial Infections Surveillance (JANIS) network. Patients who underwent 1 of 6 digestive system procedures (APPY, BILI, CHOL, COLN, GAST, or REC) were included. Logistic regression analysis was performed to predict the risk of developing SSI in the following two models: (1) selected variables that consist of an NNIS Risk Index, or (2) all variables that were collected at SSI surveillance. Model performances were assessed using the c-index. Two regression models were also developed that included or excluded factors regarding surgery duration as well as laparoscopic surgery. The difference in the standardized infection ratio (SIR) in each model was then evaluated. Surveillance data were collected from a total of 37,251 procedures from 37 institutions. Odds ratios regarding the development of SSI were generally different between procedures and risk factors. Except for APPY, the c-index was statistically greater in the model with all variables than in the model including risk index factors only (p |
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H. Fukuda, K. Morikane, M. Kuroki, S. Kawai, K. Hayashi, Y. Ieiri, H. Matsukawa, K. Okada, F. Sakamoto, T. Shinzato, S. Taniguchi, Impact of surgical site infections after open and laparoscopic colon and rectal surgeries on postoperative resource consumption, INFECTION, 10.1007/s15010-012-0317-7, 40, 6, 649-659, 2012.12, Purpose To estimate the impact of surgical site infection (SSI) on postoperative resource consumption for colon and rectal open and laparoscopic surgeries after accounting for infection depth and patient characteristics, and to compare these estimates among institutions.
Methods We collected administrative and SSI-related data from eight Japanese hospitals, and used generalized linear models to estimate excess postoperative length of stay (LOS) and charges attributable to SSI. Covariates included wound class, American Society of Anesthesiologists (ASA) score, operation time, emergency, colostomy, trauma, implant, and comorbidities.
Results We examined 1,108 colon surgery (CS) and 477 rectal surgery (RS) patients. For open surgery, the postoperative LOS in non-SSI patients was 13.5 (CS) and 15.9 days (RS). Compared with non-SSI patients, the postoperative LOS increased by 4.5 (CS) and 2.8 days (RS) for superficial SSI, 6.8 (CS) and 8.5 days (RS) for deep SSI, and 7.8 and 9.5 days for space/organ SSI. For laparoscopic surgery, the postoperative LOS was 9.8 (CS) and 14.6 days (RS). SSI was significantly associated with increased postoperative LOS for superficial SSI [by 4.8 (CS) and 3.6 days (RS)], deep SSI [by 10.3 (CS) and 23.9 days (RS)], and space/organ SSI [by 8.9 days (RS)]. The postoperative LOS among hospitals was 3.8-10.4 days (CS) and 1.3-12.2 days (RS). Postoperative SSI-attributable charges ranged from $386 to $2,873, depending on organ, procedure, and infection depth.
Conclusions This study quantified the impact of SSIs on resource consumption and confirmed significant cost variations among hospitals. These variations could not be explained by patient characteristics or infection type.. |
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CLINICAL EPIDEMIOLOGY OF FALLS/SLIPS BASED ON INCIDENT REPORTING DATA AT A TEACHING HOSPITAL IN JAPAN : A RETROSPECTIVE CASE STUDY
To understand how Falls/Slips (Falls) occurred at hospitals, the epidemiological aspects were explored by using incident reporting and administrative profiling data. There were 7,717 incident reports collected between 2007 and 2009 FY at a teaching hospital in Japan. They included 1,764 reports for Falls and Falls rate (FR) was 1.84/1,000 patient-days (1,000 pt･dys). Of 1,764 cases for Falls, Mean age±SD (standard deviation) were 66.9±19.2 y.o. for male (950 cases) and 69.9±19.2 y.o. for female (814 cases). FRs were 2.06 for male and 1.87/1,000 pt･dys for female.
FR in 70's (555 cases) was 2.82/1,000 pt･dys and the highest by age. With clinical services, FR of orthopedics was 1.14 and FR of cardiovascular and respiratory medicine were 1.97. FRs at internal medical services was higher than those at surgical services.
Furthermore, with respect to duration between admission and Falls, FR for the second day after admission was 0.16/1,000 pt･dys （118 cases） and the highest, 0.12 （84 cases） for the third day after admission, and 0.11 （78 cases） for the date of admission, and FR was getting lower day by day. The mean of duration was 12.4 days, and the cumulative percentage exceeded 50% on the eleventh day after admission.
Since the epidemiological characteristics of Falls are explored from the viewpoint of FR, appropriate and effective actions for patient safety are needed.. |
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ANALYSIS OF CHANGES IN ACCESSIBILITY BY TRANSFERRING PATIENTS FROM ACUTE CARE HOSPITALS TO CONVALESCENT HOSPITALS USING GEOGRAPHIC INFORMATION SYSTEM (GIS) : A regional cooperative critical-path for femoral neck fracture as an example
Promotion of regional referral systems, such as regional cooperative critical-paths, enables patients to effectively and safely receive medical care, while benefiting from the advancement and specialization of technology. On the other hand, the influence of the promotion of referral systems on accessibility, such as trends in the movement of patients has scarcely been elucidated.
Therefore, the purpose of this study was (1) to visualize the areas from which patients are drawn to hospitals, and (2) to elucidate changes in accessibility by transferring patients to convalescent hospitals using geographic information system (GIS), in acute care hospitals in regions with advanced regional cooperation.
In this study, substantial areas covered by acute care hospitals were wider than secondary medical areas, and 32.5% patients were transferred to convalescent hospitals outside the secondary medical areas. Geographic dissociation between secondary medical areas established by the Medical Service Act and the actual areas covered by hospitals were clarified. It was suggested that the evaluation of accessibility using GIS can be utilized in developing health resources reflecting the actual state of health care and in making health plans.. |
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The challenge of conducting the effectiveness analysis for patient safety measures: lessons from measures to boost incident reporting.. |
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THE FEATURES OF THE IMPLEMENTATION OF REGIONAL LIAISON CRITICAL PATHWAYS FOR HIP FRACTURE AND STROKE
Objective:The objective of this study is (1) to reveal hospital factors associated with the strength of a local healthcare network, and (2) to assess whether the implementation of a liaison critical pathway promotes differentiated functionality of the hospitals.
Methods:This study utilized a questionnaire to collect patient volume, average length of stay, details of the pathways used, and characteristics of the regions from all 625 hospitals that implemented a liaison critical pathway. The data was analyzed using linear regression modeling.
Results:Of the 625 hospitals surveyed, 232 (37.1%) hospitals participated in the study. In terms of hip fracture, hospitals with high patient volume (p=0.002) and short average length of stay (p=0.005) were related to high applicability of a liaison critical pathway. The average length of stay was significantly shorter by 12.8% in hospitals implementing the liaison critical pathway with specific criteria for discharge from acute hospital (p=0.036) when compared to hospitals without specific discharge criteria.
Conclusions:This study suggested an importance of discharge criteria in the liaison critical pathway.. |
| 72. |
Haruhisa Fukuda, Estimates of Postoperative Resource Utilization Attributable to Surgical Site Infection in Gastrectomy Patients
Evidence from the JANIS/DPC Integrated Database, Japanese Journal of Environmental Infections, 10.4058/jsei.27.389, 27, 6, 389-396, 2012.01, Issues of introducing cost-effectiveness analysis in the field of infection control are inevitably controversial. However, cost of illness studies, which are essential for cost-effectiveness analysis, have not been adequately carried out in Japan. This study estimated postoperative resource consumption attributable to surgical site infection (SSI) in gastrectomy patients who underwent gastrectomy between July 2007 and December 2010 at six participating hospitals. The JANIS/DPC Integrated Database was developed after collecting JANIS-related data and administrative DPC data. The generalized linear model was used to estimate excess postoperative length of stay (LOS) and charges (based on fee-for-service) attributable to SSI. A total of 42 SSI cases were identified among 857 surgeries. The generalized linear model was used to estimate the impact of SSI and revealed that compared with non-SSI patients, postoperative LOS and charges increased by 6.6 days and 206,000 yen for superficial SSI patients, 12.8 days and 398,000 yen for deep SSI patients, and 18.3 days and 1,021,000 yen for organ/space SSI patients, respectively. The JANIS/DPC Integrated Database was developed by combining JANIS-related data and DPC data and used to estimate postoperative extra resource consumption in gastrectomy patients at six hospitals. These data may prove useful in cost-effectiveness analysis for future infection control programs in Japan.. |
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H. Fukuda, J. Lee, Y. Imanaka, Costs of hospital-acquired infection and transferability of the estimates: a systematic review, INFECTION, 10.1007/s15010-011-0095-7, 39, 3, 185-199, 2011.06, Hospital-acquired infections (HAIs) present a substantial problem for healthcare providers, with a relatively high frequency of occurrence and considerable damage caused. There has been an increase in the number of cost-effectiveness and cost-savings analyses of HAI control measures, and the quantification of the cost of HAT (COHAI) is necessary for such calculations. While recent guidelines allow researchers to utilize COHAI estimates from existing published literature when evaluating the economic impact of HAI control measures, it has been observed that the results of economic evaluations may not be directly applied to other jurisdictions due to differences in the context and circumstances in which the original results were produced. The aims of this study were to conduct a systematic review of published studies that have produced COHAI estimates from 1980 to 2006 and to evaluate the quality of these estimates from the perspective of transferability. From a total of 89 publications, only eight papers (9.0%) had a high level of transferability in which all components of costs were described, data for costs in each component were reported, and unit costs were estimated with actual costing. We also did not observe a higher citation level for studies with high levels of transferability. We feel that, in order to ensure an appropriate contribution to the infection control program decision-making process, it is essential for researchers who estimate COHAI, analysts who use COHAI estimates for decision-making, as well as relevant journal reviewers and editors to recognize the importance of a transferability paradigm.. |
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Haruhisa Fukuda, Hirohisa Imai, Cost effectiveness analysis of liver transplantation, Liver Cancer: Causes, Diagnosis and Treatment, 195-222, 2011.04. |
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H. Fukuda, J. Lee, Y. Imanaka, Variations in analytical methodology for estimating costs of hospital-acquired infections: a systematic review, JOURNAL OF HOSPITAL INFECTION, 10.1016/j.jhin.2010.10.006, 77, 2, 93-105, 2011.02, Quantifying the additional costs of hospital-acquired infections (COHAI) is essential for developing cost-effective infection control measures. The methodological approaches to estimate these costs include case reviews, matched comparisons and regression analyses. The choice of cost estimation methodologies can affect the accuracy of the resulting estimates, however, with regression analyses generally able to avoid the bias pitfalls of the other methods. The objective of this study was to elucidate the distributions and trends in cost estimation methodologies in published studies that have produced COHAI estimates. We conducted systematic searches of peer-reviewed publications that produced cost estimates attributable to hospital-acquired infection in MEDLINE from 1980 to 2006. Shifts in methodologies at 10-year intervals were analysed using Fisher's exact test. The most frequent method of COHAI estimation methodology was multiple matched comparisons (59.6%), followed by regression models (25.8%), and case reviews (7.9%). There were significant increases in studies that used regression models and decreases in matched comparisons through the 1980s, 1990s and post-2000 (P = 0.033). Whereas regression analyses have become more frequently used for COHAI estimations in recent years, matched comparisons are still used in more than half of COHAI estimation studies. Researchers need to be more discerning in the selection of methodologies for their analyses, and comparative analyses are needed to identify more accurate estimation methods. This review provides a resource for analysts to overview the distribution, trends, advantages and pitfalls of the various existing COHAI estimation methodologies. (C) 2010 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.. |
| 76. |
S. E. Regenbogen, M. Hirose, Y. Imanaka, E-H Oh, H. Fukuda, A. A. Gawande, T. Takemura, H. Yoshihara, A comparative analysis of incident reporting lag times in academic medical centres in Japan and the USA, QUALITY & SAFETY IN HEALTH CARE, 10.1136/qshc.2008.029215, 19, 6, e10, 2010.12, Background Delays in reporting of medical errors may signal deficiencies in the performance of hospital-based incident reporting. We sought to understand the characteristics of hospitals, providers and patient injuries that affect such delays.
Setting and Methods All incident reports filed between May 2004 and August 2005 at the Kyoto University Hospital (KUH) in Japan and the Brigham and Women's Hospital (BWH) in the USA were evaluated. Lag time between each event and the submission of an incident report were computed. Multivariable Poisson regression with overdispersion, to control for previously described confounding factors and identify independent predictors of delays, was used.
Results Unadjusted lag times were significantly longer for physicians than other reporters (3.6 vs 1.8 days, pConclusions Lag time provides a novel and useful metric for evaluating the performance of hospital-based incident reporting systems. Across two very different health systems, physicians reported far fewer events, with significant delays compared with other providers. Even after controlling for important confounding factors, lag times at KUH were nearly triple those at BWH, suggesting significant differences in the performance of their reporting systems, potentially attributable to either the ease of online reporting at BWH or to the greater attention to patient safety reporting in that hospital.. |
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H. Fukuda, Y. Imanaka, M. Hirose, K. Hayashida, Impact of system-level activities and reporting design on the number of incident reports for patient safety, QUALITY & SAFETY IN HEALTH CARE, 10.1136/qshc.2008.027532, 19, 2, 122-127, 2010.04, Background Incident reporting is a promising tool to enhance patient safety, but few empirical studies have been conducted to identify factors that increase the number of incident reports.
Objective To evaluate how the number of incident reports are related to system-level activities and reporting design.
Methods A questionnaire survey was administered to all 1039 teaching hospitals in Japan. Items on the survey included number of reported incidents; reporting design of incidents; and status for system-level activities, including assignment of safety managers, conferences, ward rounds by peers, and staff education. Staff education encompasses many aspects of patient safety and is not limited to incident reporting. Poisson regression models were used to determine whether these activities and design of reporting method increase incident reports filed by physicians and nurses.
Results Educational activities were significantly associated with reporting by physicians (53% increase, p Conclusion In accordance with the suggestions by previous studies that examined staff perceptions and attitudes, this study empirically demonstrated that to decrease burden to reporting and to implement staff educations may improve incident reporting.. |
| 78. |
Haruhisa Fukuda, Yuichi Imanaka, Tatsuro Ishizaki, Kazuhide Okuma, Takako Shirai, Change in clinical practice after publication of guidelines on breast cancer treatment, INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE, 10.1093/intqhc/mzp037, 21, 5, 372-378, 2009.10, Objective. Several studies raise questions about whether clinical practice guidelines actually guide practice. We evaluated patterns of use of breast-conserving surgery (BCS) over time to examine the effect of guideline publication.
Design. Retrospective analysis of time-series data on breast cancer treatment. Multiple logistic regression analysis was performed, adjusting for covariates including the patient's age, comorbidity status and admission year, to assess whether the use of BCS was higher after publication of treatment guidelines.
Setting. Five teaching hospitals participating in the Quality Improvement/Indicator Project (QIP) in Japan.
Participants. Female breast cancer patients who received surgical treatment at five teaching hospitals from January 1996 through December 2007 (n = 2199).
Main Outcome Measure. Rates of use of BCS.
Results. The proportion of BCS use increased from 26.4% before guideline publication to 59.9% after guideline publication in Japan. After controlling for other characteristics, the use of BCS has increased significantly over time, especially since 2001. Women aged 70 years and older (P=0.004) and those with any comorbidity (P Conclusions. This study demonstrated that the adjusted proportion of BCS has increased dramatically since 2001, 2 years after guideline publication in Japan and this is consistent with a relationship between guideline publication and a change in this clinical practice.. |
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Haruhisa Fukuda, Yuichi Imanaka, Assessment of transparency of cost estimates in economic evaluations of patient safety programmes, JOURNAL OF EVALUATION IN CLINICAL PRACTICE, 10.1111/j.1365-2753.2008.01033.x, 15, 3, 451-459, 2009.06, Transparency of costing is essential for decision-makers who require information on the efficiency of a health care programme, because effective decisions depend largely on applicability to their settings. The main objectives of this study were to assess published studies for transparency of cost estimates.
We first developed criteria with two axes by reviewing publications dealing with economic evaluations and cost accounting studies: clarification of the scope of costing and accuracy of method evaluating costs. We then performed systematic searches of the literature for studies which estimated prevention costs and assessed the transparency and accuracy of costing based on our criteria.
Forty studies met the inclusion criteria. Half of the studies reported data for both the quantity and unit price of programmes in regard to prevention costs. Although 30 studies estimated costs of adverse events, 19 of these described the scope of costing only, and just five studies used a micro-costing method. Among 30 studies that estimated 'gross cost savings' and 'net cost savings', there was a huge discrepancy in labels.
Even if a cost study was conducted in accordance with existing techniques of economic evaluation which mostly paid attention to internal validity of cost estimates, without adequate explanation of the process of costing, reproducibility cannot be assured and the study may lose its value as scientific information. This study found that there is tremendous room for improvement.. |
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Haruhisa Fukuda, Yuichi Imanaka, Hiroe Kobuse, Kenshi Hayashida, Genki Murakami, The subjective incremental cost of informed consent and documentation in hospital care: a multicentre questionnaire survey in Japan, JOURNAL OF EVALUATION IN CLINICAL PRACTICE, 10.1111/j.1365-2753.2008.00987.x, 15, 2, 234-241, 2009.04, Objective To reveal the amount of time and financial cost required to obtain informed consent and to preserve documentation.
Methods The questionnaire was delivered to all staff in six acute care public hospitals in Japan. We examined health care staff perceptions of the time they spent obtaining informed consent and documenting information. All data were collected in 2006 and estimates in the past week in 2006 were compared to estimates of time spent in a week in 1999. We also calculated the economic costs of incremental amounts of time spent in these procedures.
Results In 2006, health care staff took about 3.89 hours [95% Confidence Interval (CI) 3.71-4.07] per week to obtain informed consent and 6.64 hours (95% CI 6.40-6.88) per week to write documentation on average. Between 1999 and 2006, the average amount of time for conducting informed consent was increased to 0.67 (P Conclusions We found a considerable increase in time spent on informed consent and documentation, and associated cost over a 7-year time period. Although greater attention to the informed consent process should be paid to ensure the notions of patient autonomy and self-determination, the increased resources devoted to these practices must be considered in light of current cost containment policies.. |
| 81. |
Haruhisa Fukuda, Yuichi Imanaka, Masahiro Hirose, Kenshi Hayashida, Factors associated with system-level activities for patient safety and infection control, HEALTH POLICY, 10.1016/j.healthpol.2008.04.009, 89, 1, 26-36, 2009.01, Objective: We examined the relationship between hospital structural characteristics and system-level activities for patient safety and infection control, for use in designing, an incentive structure to promote patient safety.
Methods: This study utilized a questionnaire to collect institutional data about hospital infrastructure and volume of patient safety activities from all 1039 teaching hospitals in Japan. The patient safety activities were focused on meetings and conferences, internal audits, staff education and training, incident reporting and infection surveillance. Generalized linear modeling was used.
Results: Of the 1039 hospitals surveyed, 418 (40.2%) hospitals participated. The amount of activities significantly increased by over 30% in hospitals with dedicated patient safety and infection control full-time staff (P Conclusions: Hospitals with increased resources had greater spread of patient safety and infection control activities. To promote patient safety programs in hospitals, it is imperative that policy makers require the assignment of dedicated full-time staff to patient safety. Economic Support for hospitals will also be required to assure that safety programs are Sustainable. (C) 2008 Elsevier Ireland Ltd. All rights reserved.. |
| 82. |
Haruhisa Fukuda, Yuichi Imanaka, Masahiro Hirose, Kenshi Hayashida, Economic evaluations of maintaining patient safety systems in teaching hospitals, HEALTH POLICY, 10.1016/j.healthpol.2008.04.004, 88, 2-3, 381-391, 2008.12, Objective: The aim of this study was to assess the status and the cost of hospital patient safety systems. Methods: We conducted a national questionnaire survey of all the 1039 teaching hospitals in Japan. The study was constructed to evaluate the costs of the systems for patient safety focused on staff assignment, meetings and conferences, internal audit, staff education and training, incident reporting, infection surveillance, infectious disposal, management of medication use, clinical engineering, and patient counseling.
Results: The status to maintain patient safety systems might be at least as decent. The mean estimated total cost of systems for patient safety was US$ 20,449 (95% confidence interval [CI], 19,632-21,266) per 100 bed-months or US$ 8.52 (95% CI, 8.18-8.86) per inpatient-day. The ratio of costs to revenue was 1.68% (95% CI, 1.61-1.75). The annual necessary costs occurring in hospitals where the costs of patient safety were under the average level across all the 1032 teaching hospitals in Japan was US$ 259.7 million.
Conclusions: Our results show that hospital-wide activities for patient safety pose significant costs to hospitals and national healthcare systems. Our data may provide financial information for designing and improving patient safety systems. (C) 2008 Elsevier Ireland Ltd. All rights reserved.. |
| 83. |
Haruhisa Fukuda, Yuichi Imanaka, Kenshi Hayashida, Cost of hospital-wide activities to improve patient safety and infection control: A multi-centre study in Japan, HEALTH POLICY, 10.1016/j.healthpol.2008.02.006, 87, 1, 100-111, 2008.07, Objective: The aim of this study was to assess the financial costs to hospitals for the implementation of hospital-wide patient safety and infection control programs.
Methods: We conducted questionnaire surveys and structured interviews in seven acute-care teaching hospitals with an established reputation for their efforts towards improving patient safety. We defined the scope of patient safety activities by use of an incremental activity measure between 1999 and 2004. Hospital-wide incremental manpower, material, and financial resources to implement patient safety programs were measured.
Results: The total incremental activities were 19,414-78,540 person-hours per year. The estimated incremental costs of activities for patient safety and infection control were calculated as US$ 1.100-2.335 million per year, equivalent to the employment of 17-40 full-time healthcare staff. The ratio of estimated costs to total medical revenue ranged from 0.55% to 2.57%. Smaller hospitals tend to shoulder a higher burden compared to larger hospitals.
Conclusions: Our study provides a framework for measuring hospital-wide activities for patient safety. Study findings suggest that the total amount of resources is so great that cost-effective and evidence-based health policy is needed to assure the sustainability of hospital safety programs. (c) 2008 Elsevier Ireland Ltd. All rights reserved.. |
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Tatsuro Ishizaki, Yuichi Imanaka, Miho Sekimoto, Haruhisa Fukuda, Hanako Mihara, Comparisons of risk-adjusted clinical outcomes for patients with aneurysmal subarachnoid haemorrhage across eight teaching hospitals in Japan, JOURNAL OF EVALUATION IN CLINICAL PRACTICE, 10.1111/j.1365-2753.2007.00882.x, 14, 3, 416-421, 2008.06, Objectives To assess predictive value of patient characteristics and severity of aneurysmal subarachnoid haemorrhage (SAH) patients for clinical outcomes, and thereby estimate risk-adjusted clinical outcomes and compare the outcomes across hospitals.
Methods We selected 256 aneurysmal SAH patients from eight teaching hospitals in Japan. The clinical outcomes of patients at the time of discharge were assessed by the Glasgow Outcome Scale (GOS). A multiple logistic regression analysis was performed to identify predictors for the GOS status at the time of discharge. The risk-adjusted proportion of patients with a favourable GOS outcome was then estimated for each facility and compared across hospitals.
Results The logistic regression analysis revealed that younger age (P Conclusion After comparison of risk-adjusted values across hospitals, the clinical management methods of the hospital that showed the best performance were examined and shared among providers.. |
| 85. |
PROFILING OF DEVELOPMENT AND IMPLEMENTATION OF PATIENT SAFETY SYSTEMS IN TEACHING HOSPITALS. |
| 86. |
Kenshi Hayashida, Yuichi Imanaka, Haruhisa Fukuda, Measuring hospital-wide activity volume for patient safety and infection control: a multi-centre study in Japan, BMC HEALTH SERVICES RESEARCH, 10.1186/1472-6963-7-140, 7, 140, 2007.09, Background: In Japan, as in many other countries, several quality and safety assurance measures have been implemented since the 1990' s. This has occurred in spite of cost containment efforts. Although government and hospital decision-makers demand comprehensive analysis of these activities at the hospital-wide level, there have been few studies that actually quantify them. Therefore, the aims of this study were to measure hospital-wide activities for patient safety and infection control through a systematic framework, and to identify the incremental volume of these activities implemented over the last five years.
Methods: Using the conceptual framework of incremental activity corresponding to incremental cost, we defined the scope of patient safety and infection control activities. We then drafted a questionnaire to analyze these realms. After implementing the questionnaire, we conducted several in-person interviews with managers and other staff in charge of patient safety and infection control in seven acute care teaching hospitals in Japan.
Results: At most hospitals, nurses and clerical employees acted as the main figures in patient safety practices. The annual amount of activity ranged from 14,557 to 72,996 person-hours ( per 100 beds: 6,240; per 100 staff: 3,323) across participant hospitals. Pharmacists performed more incremental activities than their proportional share. With respect to infection control activities, the annual volume ranged from 3,015 to 12,196 person-hours ( per 100 beds: 1,141; per 100 staff: 613). For infection control, medical doctors and nurses tended to perform somewhat more of the duties relative to their share.
Conclusion: We developed a systematic framework to quantify hospital-wide activities for patient safety and infection control. We also assessed the incremental volume of these activities in Japanese hospitals under the reimbursement containment policy. Government and hospital decision makers can benefit from this type of analytic framework and its empirical findings.. |
| 87. |
Edward Evans, Yuichi Imanaka, Miho Sekimoto, Tatsuro Ishizaki, Kenshi Hayashida, Haruhisa Fukuda, Eun-Hwan Oh, Risk adjusted resource utilization for ami patients treated in Japanese hospitals, HEALTH ECONOMICS, 10.1002/hec.1177, 16, 4, 347-359, 2007.04, Though risk adjustment is necessary in order to make equitable comparisons of resource utilization in the treatment of acute myocardial infarction patients, there is little in the literature that can be practically applied without access to clinical records or specialized registries. The aim of this study is to show that effective models of resource utilization can be developed based on administrative data, and to demonstrate a practical application of the same models by comparing the risk-adjusted performance of the hospitals in our dataset. The study sample included 1748 AMI cases discharged front 10 large, private teaching hospitals in Japan, between 10 April 2001 and 30 June 2004. Explanatory variables included procedures (CABG and PCI), length of stay, outcome, patient demographics, diagnosis and comorbidity status. Multiple linear regression models constructed for the study were able to account for 66.5, 27.7, and 58.4% of observed variation in total charges, length of stay and charges per day, respectively. The performance of models constructed for this study was comparable to or better than performance reported by other studies that made use of explanatory variables extracted from clinical data. The use of administrative data in risk adjustment makes broad scale application of risk adjustment feasible. Copyright (c) 2006 John Wiley & Soils, Ltd.. |
| 88. |
K. Hayashida, Y. Imanaka, M. Sekimoto, H. Kobuse, Haruhisa Fukuda, Evaluation of acute myocardial infarction in-hospital mortality using a risk-adjustment model based on Japanese administrative data, Journal of International Medical Research, 10.1177/147323000703500502, 35, 5, 590-596, 2007.01, This study aimed to develop a new risk-adjustment method to assess acute myocardial infarction (AMI) in-hospital mortality. Risk-adjustment was based on variables obtained from administrative data from Japanese hospitals, and included factors such as age, gender, primary diagnosis and co-morbidity. The infarct location was determined using the criteria of the International Classification of Diseases (10th version). Potential comorbidity risk factors for mortality were selected based on previous studies and their critical influence analysed to identify major co-morbidities. The remaining minor co-morbidities were then divided into two groups based on their medical implications. The major co-morbidities included shock, pneumonia, cancer and chronic renal failure. The two minor co-morbidity groups also demonstrated a substantial impact on mortality. The model was then used to assess clinical performance in the participating hospitals. Our model reliably employed the available data for the risk-adjustment of AMI mortality and provides a new approach to evaluating clinical performance.. |
