Opinions on research involving human embryo models by researchers and the general public.

Rules and ethical considerations regarding research on embryo models have been debated across numerous countries. In this paper, we provide insights from our attitude survey conducted among Japanese researchers, including members of the Japanese Society for Regenerative Medicine, and among the general public residing in Japan, the US, the UK, Canada, and Australia. Our survey revealed that many researchers expressed the need for clear guidelines for embryo model research. Furthermore, a minority but significant portion of the general public in each country expressed opposition to research on embryo models but did not oppose research involving real embryos.

Patient survey on cancer genomic medicine in Japan under the national health insurance system.

In Japan, comprehensive genomic profiling (CGP) tests have been reimbursed under the national health care system for solid cancer patients who have finished standard treatment. More than 50,000 patients have taken the test since June 2019. We performed a nation-wide questionnaire survey between March 2021 and July 2022. Questionnaires were sent to 80 designated Cancer Genomic Medicine Hospitals. Of the 933 responses received, 370 (39.7%) were web based and 563 (60.3%) were paper based. Most patients (784, 84%) first learned about CGP tests from healthcare professionals, and 775 (83.1%) gave informed consent to their treating physician. At the time of informed consent, they were most worried about test results not leading to novel treatment (536, 57.4%). On a scale of 0-10, 702 respondents (75.2%) felt that the explanations of the test result were easy to understand (7 or higher). Ninety-one patients (9.8%) started their recommended treatment. Many patients could not receive recommended treatment because no approved drugs or clinical trials were available (102/177, 57.6%). Ninety-eight patients (10.5%) did not wish their findings to be disclosed. Overall satisfaction with the CGP test process was high, with 602 respondents (64.5%) giving a score of 7-10. The major reason for choosing 0-6 was that the CGP test result did not lead to new treatment (217/277, 78.3%). In conclusion, satisfaction with the CGP test process was high. Patients and family members need better access to information. More patients need to be treated with genomically matched therapy.

Using the AllerSearch Smartphone App to Assess the Association Between Dry Eye and Hay Fever: mHealth-Based Cross-Sectional Study.

BACKGROUND: Dry eye (DE) and hay fever (HF) show synergistic exacerbation of each other's pathology through inflammatory pathways. OBJECTIVE: This study aimed to investigate the association between DE and HF comorbidity and the related risk factors. METHODS: A cross-sectional observational study was conducted using crowdsourced multidimensional data from individuals who downloaded the AllerSearch smartphone app in Japan between February 2018 and May 2020. AllerSearch collected the demographics, medical history, lifestyle and residential information, HF status, DE symptoms, and HF-related quality of life. HF symptoms were evaluated using the nasal symptom score (0-15 points) and nonnasal symptom score (0-12 points). HF was defined by the participants' responses to the questionnaire as HF, non-HF, or unknown. Symptomatic DE was defined as an Ocular Surface Disease Index total score (0-100 points), with a threshold score of 13 points. HF-related quality of life was assessed using the Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire (0-68 points). We conducted a multivariable linear regression analysis to examine the association between the severity of DE and HF symptoms. We subsequently conducted a multivariable logistic regression analysis to identify the factors associated with symptomatic DE (vs nonsymptomatic DE) among individuals with HF. Dimension reduction via Uniform Manifold Approximation and Projection stratified the comorbid DE and HF symptoms. The symptom profiles in each cluster were identified using hierarchical heat maps. RESULTS: This study included 11,284 participants, classified into experiencing HF (9041 participants), non-HF (720 participants), and unknown (1523 participants) groups. The prevalence of symptomatic DE among individuals with HF was 49.99% (4429/9041). Severe DE symptoms were significantly associated with severe HF symptoms: coefficient 1.33 (95% CI 1.10-1.57; P<.001) for mild DE, coefficient 2.16 (95% CI 1.84-2.48; P<.001) for moderate DE, and coefficient 3.80 (95% CI 3.50-4.11; P<.001) for severe DE. The risk factors for comorbid symptomatic DE among individuals with HF were identified as female sex; lower BMI; medicated hypertension; history of hematologic, collagen, heart, liver, respiratory, or atopic disease; tomato allergy; current and previous mental illness; pet ownership; living room and bedrooms furnished with materials other than hardwood, carpet, tatami, and vinyl; discontinuation of contact lens use during the HF season; current contact lens use; smoking habits; and sleep duration of <6 hours per day. Uniform Manifold Approximation and Projection stratified the heterogeneous comorbid DE and HF symptoms into 14 clusters. In the hierarchical heat map, cluster 9 was comorbid with the most severe HF and DE symptoms, and cluster 1 showed severe HF symptoms with minimal DE-related symptoms. CONCLUSIONS: This crowdsourced study suggested a significant association between severe DE and HF symptoms. Detecting DE among individuals with HF could allow effective prevention and interventions through concurrent treatment for ocular surface management along with HF treatment.

Hope for the best, but prepare for the worst: Social media posted by participants in stem cell clinical trials.

This article examines the influence of social media posts on clinical trials involving stem cell-based interventions. Based on the literature review, we identified three potential risks associated with social media posts regarding clinical trials that involve stem cell-based interventions: (1) threats to scientific validity, (2) amplification of excessive expectations, and (3) breaches of confidentiality. Additionally, preliminary recommendations are provided to safeguard the value of stem cell clinical trials for future patients in the age of social media. Our approach aims to safeguard the well-being of forthcoming participants and ensure the scientific validity of stem cell research, as well as possibly aid in the further development of shared guidelines for posting stem cell clinical trial information on social media platforms.

Attitudes towards human fetal tissue research: Survey of researchers and the public in Japan.

Introduction: The rules for human fetal tissue (HFT) research in Japan are unclear. Methods: In this paper, we conducted a web survey to examine the attitudes of Japanese researchers (n=535) and the public (n=3,000) toward HFT research. Results: The results demonstrated that 5.8% of researchers and 18.8% of the public explicitly opposed HFT research, and 71.8% of the researchers thought that the rules for HFT research need to be clarified. Even among researchers who intended to consider conducting HFT research, 74.2% responded that the rules should be clarified. Although different from attitudes to make decisions regarding HFT donation, being non-religious and in their reproductive age among women in the public group were factors for accepting attitudes toward HFT research. Conclusion: To establish the rules, it is necessary to develop a system that can adequately protect vulnerable women who are asked to provide HFT.

Is legislation to prevent genetic discrimination necessary in Japan? An overview of the current policies and public attitudes.

Genetic discrimination (GD) has not been discussed in East Asia as extensively as in Europe and North America. Influenced by UNESCO's universal declaration in 1997, the Japanese government took a stringent approach toward GD by releasing the Basic Principles on Human Genome Research in 2000. However, Japanese society has mostly been ignoring the prevention of GD for decades, and the principle of prohibiting GD was never adhered to in any of the Japanese laws. We conducted anonymous surveys among the general adult population in 2017 and 2022 to explore their experiences of GD and attitudes toward laws carrying penalties to prevent GD in Japan. In both years, approximately 3% of the respondents had experienced some unfavorable treatment regarding their genetic information. They showed higher recognition of the benefits of using genetic information and lower recognition of concerns about using genetic information and GD in 2022 than in 2017. However, the awareness regarding the need for legislation with penalties on GD had increased over the five-year period. In 2022, the framework of a bill to promote genomic medicine and prevent GD without any relevant penalties was released by the Bipartisan Diet Members Caucus. Considering that the absence of regulations may be a barrier to obtaining genomic medicine, as the initial step toward making the prohibition of GD more effective, legislation that no form of GD will be tolerated may stimulate education and awareness regarding respect for the human genome and its diversity.

Current situation of the hospitalization of persons without family in Japan and related medical challenges.

This study aims to determine the approximate number of hospitalizations of persons without family and the medical challenges they encounter in hospitals across Japan. Self-administered questionnaires were mailed to 4,000 randomly selected hospitals nationwide to investigate the actual conditions and problems, decision-making processes, and use of the government-recommended Guidelines for the hospitalization of, and decision-making support for, persons without family. To identify the characteristics of each region and role of hospitals, chi-square tests were used to make separate group comparisons by hospital location and type. Responses were received from 1,271 hospitals (31.2% response rate), of which 952 hospitals provided information regarding the number of admissions of persons without family. The mean (SD) and median number of hospitalizations (approximate number per year) of patients without family was 16 (79) and 5, respectively. Approximately 70% of the target hospitals had experienced the hospitalization of a person without family, and 30% of the hospitals did not. The most common difficulties encountered during the hospitalization were collecting emergency contact information, decision-making related to medical care, and discharge support. In the absence of family members and surrogates, the medical team undertook the decision-making process, which was commonly performed according to manuals and guidelines and by consulting an ethics committee. Regarding the use of the government-recommended Guidelines, approximately 70% of the hospitals that were aware of these Guidelines responded that they had never taken any action based on these Guidelines, with significant differences by region and hospital type. To solve the problems related to the hospitalization of persons without family, the public should be made aware of these Guidelines, and measures should be undertaken to make clinical ethics consultation a sustainable activity within hospitals.

Public attitudes toward cloud computing and willingness to share personal health records (PHRs) and genome data for health care research in Japan.

Japan's government aims to promote the linkage of medical records, including medical genomic testing data and personal health records (PHRs), via cloud computing (the cloud). However, linking national medical records and using them for health care research can be controversial. Additionally, many ethical issues with using cloud networks with health care and genome data have been noted. However, no research has yet explored the Japanese public's opinions about their PHRs, including genome data, being shared for health care research or the use of the cloud for storing and analyzing such data. Therefore, we conducted a survey in March 2021 to clarify the public's attitudes toward sharing their PHRs, including genome data and using the cloud for health care research. We analyzed data to experimentally create digital health basic literacy scores (BLSs). Our results showed that the Japanese public had concerns about data sharing that overlapped with structural cloud computing issues. The effect of incentives on changes in participants' willingness to share data (WTSD) was limited. Instead, there could be a correlation between WTSD and BLSs. Finally, we argue that it is vital to consider not only researchers but also research participants as value cocreators in health care research conducted through the cloud to overcome both parties' vulnerability.

Survey of Japanese researchers and the public regarding the culture of human embryos in vitro beyond 14 days.

The International Society for Stem Cell Research (ISSCR) has eliminated its prohibition on research involving the culturing of human embryos beyond 14 days within the updated 2021 guidelines. We conducted a survey of Japanese researchers working in stem cell- or embryo-related research (n = 535) and the public (n = 3,000) about their attitudes toward the 14-day rule. Among the researchers, 46.2% agreed that embryos could be cultured beyond 14 days, a result that was slightly lower among the public (37.9%). Among those that disagreed with embryo culturing beyond 14 days, 9.5% of researchers and 5.1% of the public agreed with culturing embryos within 14 days. Among the public, higher comprehension levels correlated with both agreement and disagreement with the culture of embryos beyond 14 days compared with "cannot judge." Further research and pubic discourse are necessary in order to better understand the factors informing participant decisions regarding the 14-day rule.

Expectations, concerns, and attitudes regarding whole-genome sequencing studies: a survey of cancer patients, families, and the public in Japan.

Whole-genome sequencing (WGS) is being used in research and clinical settings in cancer genomics. Studies show that cancer patients generally have positive attitudes toward tumor profiling tests; however, few works revealed their attitudes toward WGS. This study clarifies the expectations, concerns, and result preferences of cancer patients (CPs), family members (FMs) and general adults (GAs) regarding WGS study in Japan. We conducted an anonymous survey with 1204 CPs, 5958 FMs, and 2915 GAs in 2021. Despite low awareness of the WGS studies, CPs had the highest expectations for it. FMs had a higher level of concern than CPs and GAs; feeling anxious by knowing the results, being treated unfavorably if germline findings were detected. Both the FMs and CPs were highly concerned about the protection of genetic information. CPs preferred results with actionability, however, only half preferred to know germline findings. Given the possibility of detecting variants across multidisciplinary diseases and the long-term continuity of WGS research, a system is needed in which study participants can consult and receive decision-making support at any time according to their needs.

Learning to listen: A complementary approach to informed consent for patients with visual impairments.

This forum describes an exploratory approach for assisting individuals with visual impairment during the informed consent (IC) process to participate in a cutting-edge trial. Our approach has been developed to focus on potential participants' preparedness to give IC, along with the creation of supporting audio material.

[Patient and Public Involvement in Cancer Clinical Research].

The involvement of patients and the public with researchers is essential in clinical research on cancer treatment. In recent years, patient and public involvement(PPI)has been required in all medical research processes. This paper summarizes practical considerations and examples of the PPI process referred to in the"Patient and Public Involvement(PPI)Guidebook"of the Japan Agency for Medical Research and Development(AMED). The process consists of the introduction of PPI, recruitment of PPI participants, conflict of interest management and rewards for PPI participants, the confidentiality of PPI participants, and reporting results and feedback. It is difficult to provide a standardized procedure because PPI activities vary among the research projects. It is recommended to implement PPI activities into your research project by utilizing the actual cases or existing information sources.

Patient and public involvement in mobile health-based research for hay fever: a qualitative study of patient and public involvement implementation process.

BACKGROUND: Smartphones are being increasingly used for research owing to their multifunctionality and flexibility, and crowdsourced research using smartphone applications (apps) is effective in the early detection and management of chronic diseases. We developed the AllerSearch app to gather real-world data on individual subjective symptoms and lifestyle factors related to hay fever. This study established a foundation for interactive research by adopting novel, diverse perspectives accrued through implementing the principles of patient and public involvement (PPI) in the development of our app. METHODS: Patients and members of the public with a history or family history of hay fever were recruited from November 2019 to December 2021 through a dedicated website, social networking services, and web briefing according to the PPI Guidebook 2019 by the Japan Agency for Medical Research and Development. Nine opinion exchange meetings were held from February 2020 to December 2021 to collect opinions and suggestions for updating the app. After each meeting, interactive evaluations from PPI contributors and researchers were collected. The compiled suggestions were then incorporated into the app, establishing an active feedback loop fed by the consistently interactive infrastructure. RESULTS: Four PPI contributors (one man and three women) were recruited, and 93 items were added/changed in the in-app survey questionnaire in accordance with discussions from the exchange meetings. The exchange meetings emphasized an atmosphere and opportunity for participants to speak up, ensuring frequent opportunities for them to contribute to the research. In March 2020, a public website was created to display real-time outcomes of the number of participants and users' hay-fever-preventative behaviors. In August 2020, a new PPI-implemented AllerSearch app was released. CONCLUSIONS: This study marks the first research on clinical smartphone apps for hay fever in Japan that implements PPI throughout its timeline from research and development to the publication of research results. Taking advantage of the distinct perspectives offered by PPI contributors, a step was taken toward actualizing a foundation for an interactive research environment. These results should promote future PPI research and foster the establishment of a social construct that enables PPI efforts in various fields.

Patient and public involvement (PPI) plays an important role in promoting effective execution of health science research, as well as in the establishment of a social agreement and infrastructure for the care of various diseases, including cancer, chronic diseases, and allergic illnesses. Hay fever is one of the most common allergic diseases, affecting more than 30 million people in Japan. It is known for its myriad factors and diverse presentations. Previously, we developed a mobile health (mHealth) smartphone application (app) for hay fever­AllerSearch­released in February 2018. This app is capable of collecting relevant digital phenotypes and user-provided information, which are used in providing tailored, evidence-based suggestions. To our knowledge, no other studies have been conducted on the implementation of PPI in mHealth. Since hay fever presents with a wide variety of symptoms and risk factors, PPI principles appear well-suited for eliciting insights from the patient/public population and for incorporating new, expert perspectives into the research process. In this study, we included PPI contributors in the research plan, app development, and evaluation. Most notably, the survey questionnaire and user interface of the app was tailored based on PPI feedback. The updated AllerSearch app was released during this study period. Since hay fever is a widespread and variable illness, the multifaceted input from patients and public experts enabled by PPI implementation holds promise for improving society-wide healthcare and in empowering a culture toward medical involvement.

Comparison of the 2021 International Society for Stem Cell Research (ISSCR) guidelines for "laboratory-based human stem cell research, embryo research, and related research activities" and the corresponding Japanese regulations.

This paper presents a comparison of the 2021 guidelines for stem cell research and clinical translation outlined by the International Society for Stem Cell Research (ISSCR) with the current regulations in Japan regarding the performance of such research. This paper provides a convenient English-language summary of the Japanese regulations, and illustrates the difference between the ISSCR guidelines and Japanese regulations regarding the conditions of implementation of study activities using human embryos or stem cells, for researchers outside Japan. The regulations governing the performance of research activities using human embryos or stem cells in Japan are relatively complex and comprise a range of laws and guidelines; the specific rules applied depend on the characteristics of each study. Therefore, even similar research activities may differ in terms of not only the guidelines or laws implemented, but also the procedures required. Such situations may confuse researchers.

Public attitudes in the clinical application of genome editing on human embryos in Japan: a cross-sectional survey across multiple stakeholders.

Recent advances in genome editing technology are accompanied by increasing public expectations on its potential clinical application, but there are still scientific, ethical, and social considerations that require resolution. In Japan, discussions pertaining to the clinical use of genome editing in human embryos are underway. However, understanding of the public's sentiment and attitude towards this technology is limited which is important to help guide the debate for prioritizing policies and regulatory necessities. Thus, we conducted a cross-sectional study and administered an online questionnaire across three stakeholder groups: the general public, patients and their families, and health care providers. We received responses from a total of 3,511 individuals, and the attitudes were summarized and compared among the stakeholders. Based on the distribution of responses, health care providers tended to be cautious and reluctant about the clinical use of genome editing, while patients and families appeared supportive and positive. The majority of the participants were against the use of genome editing for enhancement purposes. Participants expressed the view that clinical use may be acceptable when genome editing is the fundamental treatment, the risks are negligible, and the safety of the technology is demonstrated in human embryos. Our findings suggest differences in attitudes toward the clinical use of genome editing across stakeholder groups. Taking into account the diversity of the public's awareness and incorporating the opinion of the population is important. Further information dissemination and educational efforts are needed to support the formation of the public's opinion.

Individual characteristics and associated factors of hay fever: A large-scale mHealth study using AllerSearch.

BACKGROUND: The prevalence of hay fever, a multifactorial allergic disease, is increasing. Identifying individual characteristics and associated factors of hay fever is essential for predictive, preventive, personalized, and participatory (P4) medicine. This study aimed to identify individual characteristics and associated factors of hay fever using an iPhone application AllerSearch. METHODS: This large-scale mobile health-based cross-sectional study was conducted between February 2018 and May 2020. Individuals who downloaded AllerSearch in Japan and provided a comprehensive self-assessment (general characteristics, medical history, lifestyle habits, and hay fever symptoms [score range 0-36]) were included. Associated factors of hay fever (vs. non-hay fever) and severe hay fever symptoms were identified using multivariate logistic and linear regression analyses, respectively. RESULTS: Of the included 11,284 individuals, 9041 had hay fever. Factors associated with hay fever (odds ratio) included age (0.98), female sex (1.33), atopic dermatitis (1.40), history of dry eye diagnosis (1.36), discontinuation of contact lens use during hay fever season (3.34), frequent bowel movements (1.03), and less sleep duration (0.91). The factors associated with severe hay fever symptoms among individuals with hay fever (coefficient) included age (-0.104), female sex (1.329), history of respiratory disease (1.539), history of dry eye diagnosis (0.824), tomato allergy (1.346), discontinuation of contact lens use during hay fever season (1.479), smoking habit (0.614), and having a pet (0.303). CONCLUSIONS: Our large-scale mobile health-based study using AllerSearch elucidated distinct hay fever presentation patterns, characteristics, and factors associated with hay fever. Our study establishes the groundwork for effective individualized interventions for P4 medicine.