Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program.

Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information

Participants will receive a novel return of results report that is tailored to their choices.

Return of Genetic Results: Biomarker information from cancer cells

Return of Genetic Results: Inherited mutations related to cancer

Return of Genetic Results: Inherited mutations related to other medical issues

Graham Colditz, M.D., DrPH, MPH

Bettina Drake, Ph.D., MPH

Li Ding, Ph.D.

Bettina Drake, Ph.D.

Ryan Fields, M.D.

Yin Cao, ScD, MPH

Feng Chen, Ph.D.

Patricia Dickson, M.D.

Eric Duncavage, M.D.

Mark Fiala, MSW

Aimee James, Ph.D., MPH

Reyka Jayasinge, Ph.D.

Kian-Huat Lim, M.D., Ph.D.

Erin Linnenbringer, Ph.D., MS

Jessica Mozersky, Ph.D.

Mary Politi, Ph.D.

David Spencer, M.D., Ph.D.

Tunji Toriola, M.D., Ph.D., MPH

Ravi Vij, M.D., MBA

Mark Watson, M.D., Ph.D.

Fei Wan, Ph.D.

Mike Wendl, DSC, MS, PHS

Matthew Wyczalkowski, Ph.D.

Stephanie Solomon Cargill, Ph.D., MSPH

당뇨병성 망막증과 연령 관련 황반변성을 조기 발견하기 위해 AI 지원 진단 소프트웨어의 효과를 평가하는 연구입니다.

Intervention group (physicians assisted by AI): After the fundus photography is completed, the AI software (VeriSee AMD and VeriSee DR) will automatically retrieve and analyze the image data from Picture Archiving and Communication System (PACS) to generate the results. The research team will immediately provide the AI-generate results to physicians, enabling participants to receive their reports and results during the same visit. If any abnormalities are detected, the physicians will refer the participants for further ophthalmologic evaluation.

VeriSee DR is an AI-assisted diagnosis screening tool for diabetic retinopathy, the software received medical device license approval from the TFDA in 2020 (MOHW-MD-No.006966). VeriSee AMD is an AI-assisted diagnosis screening tool for age-related macular degeneration, the software also received medical device license approval from the TFDA in 2022 (MOHW-MD-No.007652).

VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration

Control group (physicians diagnosing without AI assistance): After the fundus photography is completed, participants will need to schedule a follow-up appointment with the attending physicians to receive their report and have preliminary assessment of the possibility of DR or AMD. If the physician detects any abnormalities, the physicians will refer the participants for further ophthalmologic evaluation.

The control group will undergo the fundus photography without AI-functionality, with reports interpreted solely by physicians. Participants must schedule a follow-up visit to receive their results.

Standard fundus photography with physician interpretation

중재 그룹(AI 지원 의사): 안저 촬영이 완료되면 AI 소프트웨어(VeriSee AMD 및 VeriSee DR)가 PACS(영상저장전송시스템)에서 이미지 데이터를 자동으로 검색하고 분석하여 결과를 생성합니다. 연구팀은 AI가 생성한 결과를 즉시 의사에게 제공하여 참여자가 같은 방문 중에 보고서와 결과를 받을 수 있도록 합니다. 이상 소견이 발견되면 의사는 참여자를 추가 안과 검사를 위해 의뢰합니다.

VeriSee, 당뇨병성 망막증 및 연령 관련 황반변성을 위한 AI 지원 스크리닝 도구

대조군(AI 지원 없이 의사의 진단): 안저 촬영 완료 후, 참가자는 담당 의사와 후속 진료 예약을 하여 결과를 받고 DR 또는 AMD 가능성에 대한 예비 평가를 받아야 합니다. 의사가 이상을 발견하면, 담당 의사는 참가자를 추가 안과 검사에 의뢰합니다.

의사의 해석을 통한 표준 안저 사진 촬영

Yi-Ting Hsieh, Medical Doctor

가정의학과 및 노인의학과 외래 진료소에서 당뇨망막병증 및 연령관련 황반변성 환자를 위한 인공지능 지원 검진

The participants in the intervention group will be added to a chat group in the Zalo app, created and managed by one investigator, which is named The Dementia Caregiver Support group. Weekly, the investigator will post one of the topics identified in Phase 1. Before posting the information, the investigator will ask the participants what topic they would like to read and discuss the week after by voting the answer. The posted information will be based on evidence-based resources and consulted by geriatricians, the neurologist, and the psychologist who specialize in dementia. Immediately after posting the topic, one investigator will call the participants to ensure they read and understand the post. The chat group monitor will also collect the questions or comments from the carers who are encouraged to share their feelings or experiences with relevant questions. Then the monitor will post the answers after consulting with the experts.

The intervention will be administered to the participants via a smartphone app (Zalo app). Weekly, the investigator will post one of the eight topics identified in Phase 1 in the chat room. After posting the topic, one investigator will call the participants to ensure they read and understand the contents.

Information including knowledge and skills related to dementia patient care

The participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information.

Caregivers will be introduce to the website www.alzheimer.org to search for eligible information

Usual care

University of Medicine and Pharmacy at Ho Chi Minh City

Participants in this arm will undergo the full diagnostic procedure under investigation. This includes :

* A blood sample collected for analysis by the investigational in vitro diagnostic device targeting biomarkers associated with bipolar disorder,
* Completion of validated psychiatric questionnaires, including the Mood Disorder Questionnaire (MDQ), used as clinical reference standards,
* Collection of sociodemographic and clinical data relevant to the psychiatric profile. This arm does not involve any therapeutic intervention. The objective is to evaluate the diagnostic concordance between the blood test and psychiatric screening tools.

Participants will undergo a venous blood draw for analysis by an investigational composite medical device designed to aid in the diagnosis of bipolar disorder. The device analyzes specific circulating biomarkers hypothesized to differ between patients with bipolar disorder and those with unipolar depression.

Venous blood sample for measuring blood biomarkers related to bipolar disorder

Participants will complete validated psychiatric screening tools used as reference standards to evaluate bipolar disorder, including the Mood Disorder Questionnaire (MDQ). These tools will be used to compare their diagnostic output with that of the investigational blood test.

유전자 검사 결과 반환: 암세포의 바이오마커 정보, 유전자 검사 결과 반환: 암과 관련된 유전적 돌연변이, 유전자 검사 결과 반환: 기타 의학적 문제와 관련된 유전적 돌연변이

가정의학과 및 노인의학과 외래 진료소에서 당뇨망막병증 및 연령관련 황반변성 환자를 위한 인공지능 지원 검진

치매 환자 치료, 일반적인 치료와 관련된 지식 및 기술을 포함한 정보

양극성 장애와 관련된 혈액 바이오마커 측정을 위한 정맥혈 샘플, 표준화된 정신과적 평가 도구