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CURE OM Patient Registry Update - Jacqueline Kraska

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Jacqueline Kraska provides an update on the CURE OM Patient Registry at the 2017 CURE OM Patient & Caregiver Symposium.

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CURE OM Patient Registry Update - Jacqueline Kraska

  1. 1. 2016 CURE OM Scientific Meeting The CURE OM Registry Jacqueline Kraska – CURE OM Advisor on Patient Centered Outcomes Research
  2. 2. Agency for Healthcare Research and Quality – Community Forum White Paper “Experts agree that patient-powered registries are transforming patient/caregiver support and advocacy groups into research organizations. They also provide patients and family members another way to become engaged in research beyond the role of advisor or informant to research-generated studies.” 1
  3. 3. Patient registry “An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).” Registries for Evaluating Patient Outcomes: A User’s Guide – AHRQ 2
  4. 4. Patient-powered registry Patient-powered registries are developed, sponsored and managed by patients, family members and advocacy organizations in collaboration with disease experts. The patient community drives the collection, maintenance, analysis and dissemination of research data. 3
  5. 5. Type of study data Demographics and patient history Diagnosis Treatment and patient outcomes The natural history of disease Clinical and/or cost-effectiveness Assessing safety or harm Standards of care Patient preferences Policy Recruitment vehicle for existing clinical trials Repository for samples of blood or tissue 4
  6. 6. CURE OM Patient Registry Objectives Develop a centralized and secure database that will collect, store, and allow for analysis to better understand the natural history of ocular melanoma Define OM patient population Increase likelihood of development of effective treatments Create standards of care at different stages – providing opportunities to advocate for better insurance coverage for patients. Increase collaborative efforts between patients, clinicians, and researchers Understand patient preferences Inform research priorities Provide longitudinal view into relationship between genotype and phenotype Attract new investigators to the field Inform policy 5
  7. 7. CURE OM Registry Plan Steps completed so far: 1. Decision to have a patient reported registry 2. Initial funds raised for initiative 3. Building support and resources 4. Defined registry objectives and delivery plan 5. Partnering with academic/clinical registry 6. Formed multi-disciplinary Registry Working Group 7. Developed questionnaire for wider input 6
  8. 8. CURE OM Registry Plan Next steps: 1. Finalize registry objectives • FDA grant • Questionnaire • Working group 7
  9. 9. CURE OM Registry Plan Next steps: 2. Develop registry protocol & study docs • Intro & background • Study design • Data set: collection (what, who, when, where) & management – reliable and quality • Eligibility & consent • Governance • Data analysis, reporting & sharing • Communications 8
  10. 10. CURE OM Registry Plan Next steps: 3. Select registry tool or provider/host • User friendly – patient reported • Safe – protect patient confidentiality • Informative & engaging – retention • Compatible with other systems • Innovative – future initiatives 9
  11. 11. CURE OM Registry Plan Next steps: 4. Engage, launch & retain • Initiate communication plan • Training, test & launch of registry • Day to day management of registry • Long term sustainable funding • Retention strategy: communication, education, research, data results & developments 10
  12. 12. CURE OM Registry Plan Next steps: 5. Data analysis, dissemination & collaboration • Analyze data – CURE OM & integration with partners • Produce & disseminate reports for various parties • Foster collaborations with researchers, clinicians, industry, advocacy organizations etc., • Protocol developments & further research 11
  13. 13. CURE OM Registry outcomes Results Knowledge Empowerment Advocacy Policy Change Funding Collaborations More research 12
  14. 14. CURE OM Goals Improve patient-centered research in ocular melanoma Improve patient outcomes in ocular melanoma Improved clinical care and quality of life 13

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