Background and Objective: Japanese Stroke Society updated the Guideline for the Treatment of Stroke in 2021, recommending stricter lipid management in patients with non-cardioembolic stroke. We aimed to investigate the real-world practice of lipid management in patients with ischemic stroke admitted to a convalescent rehabilitation ward, and the impact of the new recommendations in the updated guidelines on the attainment rates of lipid management goal.

Methods: A retrospective review of medical records was conducted in patients aged 20 years or older with ischemic stroke admitted to a rehabilitation hospital between April 2017 and August 2022. The status of lipid management and use of lipid-lowering drugs before and after update of the guideline were analyzed according to the stroke subtype.

Results: Among a total of 682 patients enrolled, 267 patients who had atherothrombotic stroke were analyzed. The proportion of patients attaining the lipid management goal was approximately 70％ both before and after the guideline update. The percentage of patients using statins increased significantly to 47％ after update compared with 33％ before update.

Conclusion: The results suggest that update of the guideline is associated with a trend of strengthening of lipid-lowering therapy in patients with atherothrombotic stroke in convalescent rehabilitation hospital.

Japan's Action Plan for Whole Genome Analysis states the need for patient and public involvement (PPI). We conducted an online survey and group discussion with members of the “Patient and Public Panel” at the National Cancer Center. The objective of our activities was to clarify cancer patients' interest in whole genome analysis (WGA) and their thoughts about PPI for WGA. The online survey was conducted before and after the group discussion. Respondents expected their genetic information to be used “for basic research on diseases at universities and other institutions for the benefit of future generations” and were concerned about “information leakage and misuse.” The percentage of respondents who had no concerns about the utilization of their genetic information decreased by 17.1 points and the percentage of those who were concerned about “finding out the risk of diseases I do not want to know about” increased by 11.8 points after the group discussion. The participants discussed the provision of information about WGA, concerns about WGA, willingness to participate in WGA, reasons why PPI is needed in WGA and its challenges, and the PPI activities they can join. Based on the results of the group discussion and online survey, potential WGA participants will be likely to value the information on measures against information leakage, support when a genetic disease is detected, and measures to protect genetic information and prevent disadvantages regarding genetic information. Collaboration with potential WGA participants will be instrumental in promoting PPI in WGA. Clarifying and sharing the patients' benefits of PPI with the public will motivate them to become involved.

Serious non-compliance in specified clinical trials is defined as a deviation that affects the human rights and safety of research subjects, or the reliability of the results. This survey aimed to clarify processes that were likely to cause non-compliance based on non-compliance reports. We also identified the kinds of non-compliance cases that were judged as serious.

We analyzed 67 non-compliance reports from 131 specific clinical trials conducted at our institution between April 2018 and May 2022. Non-compliance was categorized, and the trend of being judged as serious non-compliance for each category was examined using correspondence analysis.

Twenty-five of these reports were serious non-compliance reports and 42 were non-serious. We extracted 75non-compliance codes and classified them into nine categories. Most incidences of non-compliance occurred in the process of administering the study drug and obtaining study data, with each accounting for 26.7％ of the total non-compliance. With inclusion of the processes of obtaining consent and eligibility determination, 85.4％ of the total was accounted for. Serious non-compliance occurred in the processes of obtaining consent, eligibility determination, and administering the study drug in 73.3％ of the cases. The correspondence analysis showed obtaining consent and administering the study drug were processes in which determining whether there was serious non-compliance was less consistent.

We revealed the processes in which non-compliance was likely to occur in specific clinical trials and where judging whether a case constituted serious non-compliance was inconsistent. To further improve the quality of specific clinical trials in Japan, it is necessary to standardize the criteria for judging serious non-compliance.

Objective: In recent years, with increased use of health foods mainly due to raising health awareness, appropriate handling of safety information of health food products, as well as efficacy, has attracted attention. Public and businesses institutions have started developing tools to collect and provide safety information on health foods, but the application is unclear in clinical practice. In this study, we investigated exploratory the use of these information tools in insurance pharmacies to handle safety consultations from health food users and evaluated their usability in clinical practice.

Methods: Information tools were introduced for pharmacists working in insurance pharmacies. Video materials were used to provide explanations. Pharmacists evaluated and responded to consultations related to safety information from health food users.

Results: A survey was conducted on 19 pharmacists. Analysis was performed on 43 consultations. Among these, 33 (77％) of the consultants were 60 years old or older, and the contents of consultations (multiple responses allowed) were as follows: drug-health food interactions, 32 (74％); acceptability of health food use, 12 (28％); and ingredients and characteristics of health food, 3 (7％). Adverse event was consulted in one case. While information tools were helpful in responding when product information and information on drug-health food interactions were available, a lack of information on the frequency of adverse events was also noted.

Discussion: This survey highlighted the status of consultations related to health food safety information, using information tools at insurance pharmacies. We found that pharmacists could decide on whether or not to use health foods and provide information on precautions depending on the user's condition, thereby avoiding adverse events associated with health foods. In contrast, it was also considered to provide adequate and sufficient safety information for decision making of risk avoidance.