Big Data for Patients (BD4P) Program Overview

Transcription

1 Big Data for Patients (BD4P) Program Overview [Updated August 5, 2015] Proposal: Big Data for Patients (BD4P) Training Program Page 1

2 Background The new and emerging field of data science ( Big Data ) is rapidly evolving, and the methods of accessing, integrating, and interpreting data are becoming increasingly complex. Big Data efforts, including National Institutes of Health s (NIH) Big Data to Knowledge (BD2K) program, FDA s Sentinel Initiative, and the National Patient- Centered Clinical Research Network (PCORnet), which is funded by the Patient- Centered Outcomes Research Institute (PCORI) are working to gather data from various sources and formats such as electronic health records (EHRs), electronic medical records (EMRs), patient reported outcomes (PROs), and physicians notes to help inform and improve patient care. The main goals of RUF s Big Data for Patients (BD4P) Program are the: Comprehension of key Big Data concepts and uses Awareness of the promises, limitations, and potential impacts on patients Understanding of how patients can impact and shape Big Data research, institutional policy, and funding decisions Development of critical thinking skills to evaluate and discuss Big Data issues Creation of knowledge to allow you/your organizations to offer an educated perspective on issues related to Big Data Based on RUF s work with scientists and clinicians and recruitment and involvement of patient advocates in our projects and programs, we know that many people find Big Data difficult to navigate. Without training in this topic, patients and advocates may not feel comfortable or prepared for participating in this work or its design and evaluation. This is not only a setback for patient engagement, it is also a detriment to the research work. Big Data in medicine is patient data, so patient participation is vital in creating beneficial and patient-centered research initiatives. Project Scope BD4P will bring together multiple stakeholder groups to leverage collective knowledge, technical expertise, data, funding, and other resources to create a state-of-the-art patient training program focused on the opportunities and challenges posed by Big Data. BD4P will: Develop a community of informed and empowered advocates who understand what Big Data is, how it is being used in research and medicine, its promises and limitations, its challenges, its potential impact on patients, and how patients can use this knowledge. Equip trainees with the tools necessary to communicate on Big Data issues with policy makers, scientists, physicians, as well as other patients. Proposal: Big Data for Patients (BD4P) Training Program Page 2

3 Serve as a forum for networking not only between patients, but also between patients and leaders in data science who will be teaching the courses and active in the community of practice. Given the high profile of health research and initiatives using Big Data, and the growing efforts to make healthcare and medical research more patient-centered, it is critical that patients have a voice and active role in this work. It is still not completely understood how Big Data research will impact patient healthcare and medical decision making, but BD4P presents an opportunity to get ahead of the curve and ensure that patients are adequately informed and prepared to participate in this work. Process and Timeline Development of the program will be a fully collaborative process, with patients and key stakeholders involved in shaping the program every step of the way from prioritizing topics for program content and having input on program design, to actually taking the training program and providing feedback to evaluate the program and make improvements. This will ensure that the focus is not only on the impact of Big Data on patients, but also the impact that patients can have on Big Data research. Work in the first two years of BD4P can be separated into 5 overlapping phases, outlined below, that cover development, design, and implementation of the program. There will be opportunities throughout for stakeholder involvement, including (but not limited to) potential roles as advisors, steering committee members, workgroup members, speakers, and instructors. Phase 0 BD4P Program Launch July 1, 2015 Phase I Needs assessment/landscape report Surveys, interviews, and in-person consultations with patients, advocates, health research organizations, government, industry, and providers. Phase II Develop curriculum, tools, and other materials Feedback from the needs assessment will be used to inform the development of program content and delivery methods, including a core curriculum. Phase III: Holding Training Workshops Goal: 3 trainings over the first 2 years, starting small (approximately trainees), then expanding. Phase IV Build Community of Practice This platform will serve as a forum for communicating, networking, sharing ideas and information, and continuing education opportunities. Proposal: Big Data for Patients (BD4P) Training Program Page 3

4 Phase V Program evaluation, summary of learnings Evaluation feedback will be used to refine program content and structure, assess overall program performance, and inform longer-term plans for sustainability and expansion of the program. Deliverables: Landscape/needs assessment of knowledge gaps in data science Educational curriculum, tools, and materials to be made publicly available Training workshops Platform for community of practice Learnings from program evaluation with recommendations for program sustainability and expansions Program Goals and Objectives: Learning Objectives for the BD4P Training Workshops Comprehension of the key language and scientific concepts underlying Big Data Working knowledge of the Big Data landscape and how it is being used in research and medicine Awareness of the promises and limitations, and potential impact on patients Understanding how patients can impact Big Data research, institutional policy, and funding decisions Proposal: Big Data for Patients (BD4P) Training Program Page 4

5 Developing the scientific/technical literacy necessary to read, understand, and evaluate lay scientific literature about Big Data Developing critical thinking skills to evaluate and discuss Big Data research proposals BD4P Training Applications Provide the scientific and technical knowledge to allow you/your organization navigate the landscape of Big Data Apply evidence-based decision-making to key issues in Big Data research of relevance to you/your advocacy constituency Partner with scientists, clinicians, and others to ensure patient-centeredness in Big Data research Provide educated patient perspective at public forums and in print on issues related to Big Data Participate on scientific advisory committees, review panels, and study sections Longer-term objectives for BD4P include expanding the program training to additional audiences (e.g., clinicians and translational science researchers) and additional content areas (e.g., understanding risk-benefit analysis, clinical trial design, regulatory review) that would complement RUF s broader regulatory science education agenda. Governance RUF will establish a Steering Committee (SC) to provide external oversight as well as subject matter expertise that is needed to develop and implement the program. The SC will be a multi-stakeholder group made up of thought leaders in data science, patient engagement, and patient reported outcomes research. Members for all committees will be selected via an open, public process. Composition of BD4P Steering Committee: Patient Advocate: 3 members Pharmaceutical sector: 1 member Technology sector: 1 members Academia / Research Institute: 1 member At Large: 1 member The BD4P Steering Committee will also have 1 member from the FDA (appointed by the FDA), 1 member from the National Institutes of Health (appointed by the National Institutes of Health), and 1 member from the Patient Centered Outcomes Research Institute (appointed by PCORI). These 3 individuals will be non-voting members. Full details on Steering Committee including roles and responsibilities, and selection process can be found here: Proposal: Big Data for Patients (BD4P) Training Program Page 5

6 Partnership Opportunities The BD4P Program will be developed through a fully collaborative process, with patients and key stakeholders involved in shaping the program every step of the way from prioritizing topics for program content and input on program design, to actually taking the training program and providing feedback to evaluate the program and make improvements. Stakeholder meetings will be held over the course of program development. Additionally, RUF is actively exploring collaboration opportunities in support of this effort. To find out how you can get involved, contact us at BD4P@ReaganUdall.org. Proposal: Big Data for Patients (BD4P) Training Program Page 6