Japanese Initiative for Education in Pharmaceutical Medicine and Clinical Research Training

Development of new medicines has become increasingly difficult with less possibility of success in seeds-finding and ever rising operational costs. Failure to comply with ethical standards for human research protection also erodes social trust in clinical development. In order to develop competence of professionals in medicines development such as clinical investigators and drug development scientists, a variety of educational courses and training programs have been developed and executed worldwide. As Japan is no exception and shares the same concerns, significant governmental and non-governmental efforts have been made to invest in the development of academic educational courses and adherence to international standards. This article introduces examples of the adoption of technologies to realize a user-friendly and sustainable learning management as well as an adaptation of syllabuses and core curricula to meet international standards in the era of global medicines development

J-CKD-DB: a nationwide multicentre electronic health record-based chronic kidney disease database in Japan

The Japan Chronic Kidney Disease (CKD) Database (J-CKD-DB) is a large-scale, nation-wide registry based on electronic health record (EHR) data from participating university hospitals. Using a standardized exchangeable information storage, the J-CKD-DB succeeded to efficiently collect clinical data of CKD patients across hospitals despite their different EHR systems. CKD was defined as dipstick proteinuria ≥1+ and/or estimated glomerular filtration rate <60 mL/min/1.73 m² base on both out- and inpatient laboratory data. As an initial analysis, we analyzed 39, 121 CKD outpatients (median age was 71 years, 54.7% were men, median eGFR was 51.3 mL/min/1.73 m²) and observed that the number of patients with a CKD stage G1, G2, G3a, G3b, G4 and G5 were 1, 001 (2.6%), 2, 612 (6.7%), 23, 333 (59.6%), 8, 357 (21.4%), 2, 710 (6.9%) and 1, 108 (2.8%), respectively. According to the KDIGO risk classification, there were 30.1% and 25.5% of male and female patients with CKD at very high-risk, respectively. As the information from every clinical encounter from those participating hospitals will be continuously updated with an anonymized patient ID, the J-CKD-DB will be a dynamic registry of Japanese CKD patients by expanding and linking with other existing databases and a platform for a number of cross-sectional and prospective analyses to answer important clinical questions in CKD care

Validation of U.S. mortality prediction models for hospitalised heart failure in the United Kingdom and Japan

Aims Prognostic models for hospitalized heart failure (HHF) were developed predominantly for patients of European origin in the United States of America; it is unclear whether they perform similarly in other health care systems or for different ethnicities. We sought to validate published prediction models for HHF in the United Kingdom (UK) and Japan. Methods and results Patients in the UK (n =894) and Japan (n =3158) were prospectively enrolled and were similar in terms of sex (∼60% men) and median age (∼77 years). Models predicted that British patients would have a higher mortality than Japanese, which was indeed true both for in‐hospital (4.8% vs. 2.5%) and 180‐day (20.7% vs. 9.5%) mortality. The model c‐statistics for the published/derivation (range 0.70–0.76) and Japanese (range 0.75–0.77) cohorts were similar and higher than for the UK (0.62–0.75) but models consistently overestimated mortality in Japan. For in‐hospital mortality, the OPTIMIZE‐HF model performed best, providing similar discrimination in published/derivation, UK and Japanese cohorts [c‐indices: 0.75 (0.74–0.77); 0.75 (0.68–0.81); and 0.77 (0.70–0.83), respectively], and least overestimated mortality in Japan. For 180‐day mortality, the c‐statistics for the ASCEND‐HF model were similar in published/derivation (0.70) and UK [0.69 (0.64–0.74)] cohorts but higher in Japan [0.75 (0.71–0.79)]; calibration was good in the UK but again overestimated mortality in Japan. Conclusion Calibration of published prediction models appears moderately accurate and unbiased when applied to British patients but consistently overestimates mortality in Japan. Identifying the reason why patients in Japan have a better than predicted prognosis is of great interest

Validation of U.S. mortality prediction models for hospitalized heart failure in the United Kingdom and Japan: Validation of risk models in decompensated heart failure

Aims: Prognostic models for hospitalised heart failure (HHF) were developed predominantly for patients of European origin in the United States of America; it is unclear whether they perform similarly in other health-care systems or for different ethnicities. We sought to validate published prediction models for HHF in the United Kingdom (UK) & Japan.Methods and Results: Patients in the UK (894) and Japan (3,158) were prospectively enrolled and similar in terms of sex (~60% men) and median age (~77 years). Models predicted that British patients would have a higher mortality than Japanese, which was indeed true both for in-hospital [4.8% vs 2.5%] and 180-day [20.7% vs 9.5%] mortality. The model c-statistics for the published/derivation [range 0.70-0.76] and Japanese [range 0.75-0.77] cohorts were similar and higher than for the UK [0.62-0.75] but models consistently over-estimated mortality in Japan. For in-hospital mortality, OPTIMIZE-HF performed best, providing similar discrimination in published/derivation, UK and Japanese cohorts [c-indices: 0.75 (0.74-0.77); 0.75 (0.68 - 0.81) and 0.77 (0.70 - 0.83)], and least over-estimated mortality in Japan. For 180-day mortality, the cstatistics for ASCEND-HF were similar in published/derivation [0.70] and UK [0.69 (0.64 - 0.74)] cohorts but higher in Japan [0.75 (0.71 - 0.79)]; calibration was good in the UK but again over-estimated mortality in Japan.Conclusion: Calibration of published prediction models appear moderately accurate and unbiased when applied to British patients but consistently overestimate mortality in Japan. Identifying the reason why patients in Japan have a better than predicted prognosis is of great interest

Otterbein Aegis Spring 2020

Contents: Editors\u27 Introduction, Editorial Board Members, How the Harlem Hellfighters Would be Remembered as America\u27s Most Celebrated African American Military Unit, War Requiem, The Virtues of Scrutiny and Tenacity, Should We Shorten Grieving, The Effects of Baseball During the Fifty-Year Japanese Occupation of Taiwan, Parasitic Poverty, A View of American Society in 1967 and 1968 Through Ladies Home Journal, Sex and the Early Novel, The Closet of a Drag Queen, Hubble\u27s University, Educated, Go Ahead in the Rain: Notes to a Tribe Called Quest, Sing Unburied Sing, Children of Blood and Bone, Living a Feminist Life, The Crowded Hour Theodore Roosevelt The Rough Riders and the Dawn of the American Century, Someone Who Will Love You In All Your Damaged Glory, The Silent Patient, The Sympathizerhttps://digitalcommons.otterbein.edu/aegis_humanity/1017/thumbnail.jp

Antithrombotic Therapy To Prevent Cognitive Decline In People With Small Vessel Disease On Neuroimaging But Without Dementia

Protocolpublished_or_final_versio

Validation of U.S. mortality prediction models for hospitalized heart failure in the United Kingdom and Japan.

AIMS: Prognostic models for hospitalized heart failure (HHF) were developed predominantly for patients of European origin in the United States of America; it is unclear whether they perform similarly in other health care systems or for different ethnicities. We sought to validate published prediction models for HHF in the United Kingdom (UK) and Japan.METHODS AND RESULTS: Patients in the UK (n?=894) and Japan (n?=3158) were prospectively enrolled and were similar in terms of sex (~60% men) and median age (~77?years). Models predicted that British patients would have a higher mortality than Japanese, which was indeed true both for in-hospital (4.8% vs. 2.5%) and 180-day (20.7% vs. 9.5%) mortality. The model c-statistics for the published/derivation (range 0.70-0.76) and Japanese (range 0.75-0.77) cohorts were similar and higher than for the UK (0.62-0.75) but models consistently overestimated mortality in Japan. For in-hospital mortality, the OPTIMIZE-HF model performed best, providing similar discrimination in published/derivation, UK and Japanese cohorts [c-indices: 0.75 (0.74-0.77); 0.75 (0.68-0.81); and 0.77 (0.70-0.83), respectively], and least overestimated mortality in Japan. For 180-day mortality, the c-statistics for the ASCEND-HF model were similar in published/derivation (0.70) and UK [0.69 (0.64-0.74)] cohorts but higher in Japan [0.75 (0.71-0.79)]; calibration was good in the UK but again overestimated mortality in Japan.CONCLUSION: Calibration of published prediction models appears moderately accurate and unbiased when applied to British patients but consistently overestimates mortality in Japan. Identifying the reason why patients in Japan have a better than predicted prognosis is of great interest

Analysis of orthopaedic device development in South Africa: Mapping the landscape and understanding the drivers of knowledge development and knowledge diffusion through networks

An orthopaedic medical device refers to a part, implant, prosthetic or orthotic which is used to address damage to the body's musculoskeletal system, primarily by providing stability and mobility. Orthopaedic medical devices play a role in injury-related disorders, which have been highlighted as a key element of the quadruple burden of disease in South Africa. In this thesis, orthopaedic devices are conceptualised as a technological field and a technological innovation system (TIS) framework is applied to understand orthopaedic device development in South Africa. Knowledge development and knowledge diffusion are fundamental components of any innovation system. The thesis hypothesises that the functions “knowledge development” and “knowledge diffusion through networks” of the orthopaedic devices TIS are influenced by contextual factors. The objectives of the study are: to identify the actors who generate knowledge for orthopaedic device development and to characterise the relationships between them; to identify focus areas of orthopaedic device development; to provide insight into the drivers and barriers to knowledge development and diffusion in the TIS; and to identify the contextual factors that influence knowledge dynamics in the TIS. These objectives are investigated using social network analysis based on bibliometric data (scientific publications and patents), keyword networks, a review of institutions, and a set of case studies where the primary data source are interviews with actors. Actors producing knowledge were from the university, healthcare, industry and science council sectors, although science councils played a small role. International actors were shown to bring new ideas into the TIS. The networks were fragmented, illustrating that knowledge diffusion through the networks was limited. This was especially the case in the patent networks as many actors patent in isolation. The keyword networks highlighted unrealised collaboration potential between actors based on their common research interests. The case studies revealed features of cross-sector interaction for orthopaedic device development not evident from network analysis based on bibliometric data. Drivers of knowledge development and knowledge diffusion were: inter-sectoral collaboration; the availability of resources; the affordability of available devices; and the positive externalities of allied TISs. The main barrier to knowledge development and diffusion was in the form of barriers to intersectoral collaboration. These include unmatched expectations from partners in collaboration, different views on intellectual property ownership, and burdensome university administrative processes. The orthopaedic devices TIS was structurally coupled to the embedded TIS and sectoral contexts, and externally linked and structurally coupled to its political context. Knowledge development and diffusion was found to be positively enhanced by innovation in the additive manufacturing TIS, with shared structural elements and resources. Knowledge development and diffusion was influenced by sectoral dynamics of the university, healthcare and industry sectors. This thesis makes the following contributions. First, it applies the TIS framework to a new focus area, namely medical device development, in a developing country context. Second, it makes two unique methodological contributions: it presents an index to capture the extent of sectoral collaboration in a network; and it develops a method for determining the collaboration potential of actors in a network based on cognitive distance