Big Data for Patients (BD4P) Stakeholder Engagement Plan Index I. BD4P Program Background a. Goals and Objectives II. Participation a. How will stakeholders be engaged? i. Stakeholders ii. Workgroups III. Application a. How do we engage broader stakeholder audiences? IV. Education a. How will stakeholders be involved in education? b. How can stakeholders participate in education? V. Communications VI. Action VII. Appendix I VIII. Appendix II Stakeholder Engagement Plan 1
BD4P Program Background BD4P is a big data training program that aims to develop a network of informed and empowered patient advocates that understand the uses, purposes, and limits of big data in health. Big data is data that is generated, analyzed, and utilized in various methods. Big data in health is diverse data that is created by patients, hospitals, and researchers, and encompasses behavioral, biomedical, genetic, and other information. The new and emerging field of big data is rapidly evolving and the methods of accessing, integrating, and interpreting data are becoming increasingly complex. There are growing efforts to make healthcare and medical research more patient-centered, and patients are a critical stakeholder group that needs to have a voice and an active role in big data research initiatives. Without patients buy-in and participation, research cannot truly be patient-centered and will not benefit patients to the fullest extent. Based on RUF s recruitment and involvement of patient advocates in our projects such as IMEDS, we know that even very educated and highly motivated patient advocates find big data difficult to navigate. Without training in this topic, patients may not feel comfortable participating in big data initiatives, such as serving on advisory committees, sitting on patient panels, or engaging in research programs. Patients and advocates are engaging in comparative effectiveness research (CER), such as with training and support from PCORI, but there are not currently clear avenues for training patient participants when it comes to the broader topic of big data and its use in healthcare. Lack of education may prohibit the inclusion and meaningful participation of patient advocates in big data research design and/or evaluation. This is not only a setback for patient engagement in research, but it is also a detriment to the research work as well. Goals and Objectives BD4P will facilitate meaningful participation by equipping patient advocates with the knowledge, skills, and tools needed to both navigate and impact health research, policy, and funding decisions. The goal is to ensure that the patient voice and patients needs are central drivers of big data research efforts in healthcare and research. Funders/Sponsors Project development Training courses Advocate/participan t attendance IT resources Implementers Workgroups Meeting/course facilitators Case study providers Instructors BD4P Program Team Advisors Steering committee Subject matter experts Curriculum & material reviewers Consultants Trainees Development of Community of Practice Program & training evaluation Stakeholder Engagement Plan 2
A baseline understanding of scientific health literacy will be need to be developed and is imperative for participants to understand how to apply this knowledge in research and big data initiatives. Core objectives include: Increasing awareness of big data research and how these efforts affect patient health and outcomes Enhancing participants scientific literacy in the basic concepts and key vocabulary of big data Developing a community of informed and empowered patient advocates to feel comfortable participating in big data research and initiatives Building a community of practice that encourages patient participation and information exchange about big data and research initiatives BD4P seeks to help identify the responses to questions surrounding the use of big data in health and research. What is it? How is it being used? Who is using it? How can patients use this knowledge? What are the promises and potential? What are the challenges and limitations? How are patients impacted? How can patients make an impact? Participation BD4P will bring together stakeholders from patient advocacy, government, technology, pharmaceutical, and research organizations to create a state-of-the art training program and online community for patient advocates focused on the opportunities and challenges posed by big data. BD4P will educate patient advocates on the language, concepts, critical appraisal skills, and other pertinent aspects of big data so they can effectively and actively participate in big data initiatives. The initial phases of BD4P involve examining the current landscape of big data in health as well as conducting a needs assessment to determine knowledge gaps and solicit input on program curriculum, format, and delivery. The needs assessment focused on eliciting responses from interested stakeholders across various disciplines. Information gathered through these stakeholder consultations will help to design, implement, and evaluate the program. It will also inform the long-term engagement strategy and sustainability plan, and help to 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. How will stakeholders be engaged? Development of the BD4P program will be a fully collaborative process, with key stakeholders involved in shaping the program every step of the way. The first year of the program will focus on curriculum development. We will determine the intended audience, what questions need to be answered, and how best to present and tailor the program for maximum patient engagement and benefit. Priority tasks include selecting topics for program content, giving input on program design, participating in training programs, and providing feedback to evaluate the program and make necessary improvements. Stakeholders are a vital component of each of these activities. Possible methods for stakeholder Stakeholder Engagement Plan 3
participation throughout BD4P development are serving as funders/sponsors, advisors, implementers, and trainees. The second year of program development will include three pilot training programs scheduled to begin in the summer of 2016. Stakeholder engagement will be pivotal in identifying components for inclusion into the final course. Steering Committee The BD4P steering committee is comprised of influential thought leaders from various sectors and areas. Represented sectors include: academia, technology, industry, patient advocacy, and government. The steering committee is comprised of 9 voting members and 3 appointed non-voting members representing the FDA, NIH, and PCORI. The steering committee is responsible for providing strategic guidance on and oversight of BD4P operations, and will work with the RUF Board and project staff to ensure focus on the long-term vision of the project and its deliverables. Workgroups Workgroups can engage patients and other stakeholders as contributors and participants in BD4P and the larger science of big data. They will help to develop the curriculum, shape the program delivery and format, and assist with outreach. Interaction between workgroups, RUF, and the steering committee will be critical, and the program team will provide the coordination necessary for effective collaborations. Examples of possible workgroups are: Program Content Workgroup focus on outlining the curriculum and helping develop the necessary learning materials including case studies, study guides, one-pagers, and homework. Program Delivery and Format Workgroup focus on program structure to ensure that the program and training is done in a way that is the most useful for adult learners. Outreach Workgroup focus on the strategies to engage other patients and stakeholders from the community in big data work and solicit input to grow the community of practice. Application The first round of BD4P training sessions will focus on patient advocates. Future iterations of the program may focus on different stakeholder groups, including clinicians or researchers. Regardless of the program audience, broad stakeholder input from diverse groups is necessary for the creation and implementation of a robust and beneficial training program. It is vital to receive input from diverse stakeholders including researchers, industry, providers, etc. to ensure broad representation and contribution to program development. How do we engage broader stakeholder audiences? 1. The needs assessment survey that was distributed online between August and October 2015 received 65 responses with the majority of them being from patients, patient advocates, and people who work in the patient advocacy field. This is to be expected due to the subject matter of the project, but viewpoints from disparate sources would help to ensure a more comprehensive Stakeholder Engagement Plan 4
approach to project development. Examples of feedback RUF received from the needs assessment is included in Appendix I. 2. We also hosted an informative webinar on September 18 th to give an overview on BD4P program development and discuss the needs assessment. This webinar introduced the BD4P program to the public and gave attendees the opportunity to participate in discussions and ask questions. Examples of feedback received after the webinar is included in Appendix II. 3. RUF is hosting a public stakeholder meeting on December 9 th. This meeting will provide an opportunity for RUF to engage with its stakeholders and receive public input on its efforts with the BD4P program. The meeting will include an overview of the BD4P program, project plan and progress updates, discussion, and Q&A. Examples of methods to engage broader audiences: Targeted survey modify the existing needs assessment to formulate questions that are directed to specific groups and ask specific questions. Targeted outreach utilize members of the BD4P steering committee and RUF Board of Directors to help disseminate the survey(s) to applicable persons within their industries. Varied outreach utilize different sources for targeting necessary groups, including social media, personal interviews, focus groups, etc. Education How will stakeholders be involved in education? Broad stakeholder input is vital to develop a robust and diverse curriculum. Some ways that stakeholders can contribute to the educational component are: Attending public meetings one major focus of these meetings will be curriculum content and stakeholders will be asked to provide feedback and ideas for program substance and topics for inclusion. Workgroup participation workgroups will have varied concentrations that will focus on different aspects of curriculum and material development for the overall BD4P program. Future surveys and calls for input one of the most important aspects of the needs assessment survey was to identify content needs and desired topics for inclusion into the program; the responses received from this assessment will help with the initial development of programmatic materials. Future surveys and requests for input will be necessary to formulate the final program requirements. How can stakeholders participate in education? It will be necessary that patient advocate stakeholders participate in the initial training sessions in order to comment on the pilot trainings. Pilot training sessions are scheduled to begin the summer of 2016. Evaluation and suggestions gleaned from these pilot sessions will be utilize to help finalize the curriculum and materials needed for the final program. Materials, curriculum, teaching methods, and topics will be Stakeholder Engagement Plan 5
reviewed and revised as necessary regarding stakeholder interests. Without this input, it will be very hard to ensure that the curriculum and education is presented in a format that is both appropriate and useful for the target audience. Observations, interpretations, and comments from participant stakeholders will be necessary for the development of the final training series. Case Study Approach One proposed method for engaging stakeholders during the training sessions is through the utilization of case studies. The idea is that this approach allows the trainings to focus on real-life initiatives on different topics in big data research i.e. wearables, the Precision Medicine Initiative, social listening, surveillance efforts and use those case studies as the framework for different sessions. For example, FDA s social listening initiative could be used to highlight 1) challenges of unstructured data, 2) privacy, 3) how these data sources drive the need to look at multiple data sources collectively. Stakeholders can be utilized in the planning of these topics. They can offer suggestions of case studies to use during the class, or have bring their own projects into the class to work on and use as an example. The major benefits of utilizing a case study approach are the availabilities of varied topics and the realworld applications of big data research and initiatives for illustrating key concepts. Stakeholder input will help to drive this approach by identifying interesting and applicable case studies. Communications A clear communications plan is important for engaging patient advocates and other stakeholders in BD4P operations. Communications has to be a dual process both to stakeholders and from stakeholders. The BD4P project team will utilize stakeholder input in the development of the program, goals and objectives, and curriculum. Dynamic communications should help boost the visibility of the BD4P program within the patient advocacy, big data, and healthcare communities. The purpose of robust communications between stakeholders and the BD4P project team, steering committee, and RUF should be to identify: What stakeholders want from BD4P What stakeholders want their patient advocates to know from the training program The issues about big data that patient advocates have identified as priorities What questions stakeholders have about BD4P How stakeholders can get the most benefit from BD4P To encourage robust communications it will be necessary to use a variety of methods to engage in communications with stakeholders. Some of these methods include email, discussions at meetings, and the online community of practice. It may be necessary to build a special platform for disseminating program resources to external stakeholders (e.g. developing a formal BD4P website). Action Stakeholder engagement will be useful in driving the successful involvement of participants with the BD4P program, and the successful impact of the BD4P program. Ultimately, stakeholder input will help to Stakeholder Engagement Plan 6
develop a program that is able to create a network of informed and engaged patient advocates who want to contribute to big data research initiatives and reach out to other patient advocates. Some examples of actions that stakeholders should be engaged in to help enable program viability and longevity are: Supporting a Community of Practice the proposed BD4P website may provide discussion boards, training materials, and other features. The BD4P program team will provide the infrastructure and support needed to establish the community of practice, but the goal is for stakeholders to drive the content and activities. The community of practice is intended to serve as a forum for continuing education, dissemination of big data news and updates, networking, and posting information about future trainings. The community of practice may also serve as an area to connect trainees with areas to apply their knowledge. Funding stakeholders can use their experience and knowledge to help identify potential funding partners. Examples of funding collaborations include offers of donations, fundraising expertise, and other in-kind support. Metrics Identify prospective program outcomes and define what successful implementation for BD4P looks like. Use these ideas to identify measurable indicators of success. Once these measures have been identified, it will enable us to develop methods of evaluating the success of the problem. Stakeholder Engagement Plan 7
Appendix I Examples of responses received from the needs assessment request Please list your hopeful outcomes for the BD4P program. Increase awareness; education, resources and other support that will help increase patient-centered improvements in support of patient, family members, caregivers, doctors, researchers and other healthcare givers. An acceleration of big data research in the service of patient needs. Much big data research is directed by what's easy or what researchers see as interesting or possible. That's fine, but the curve needs a little bending in the direction of patient interest and usability/applicability. I would love for BD4P to identify ways to allow all interested patients to participate, whether it involves simple training for less involved participation or complicated training and pathways for deeper involvement in a variety of efforts. Education and Science Literacy. Ability of patients, families, advocates, and foundations to find and engage with initiatives to generate valuable/usable data, in a cost contained environment. To see data acquisition and analysis result in an understandable and translatable outcome at the point of care. I hope this project will create a new type of patient stakeholder that is well versed in basic research principles, able to communicate the voice of the patient, and understand what should/ shouldn't be expected from big data. Stakeholder Engagement Plan 8
Appendix II Examples of responses received from the September 18 th informative webinar. Responses to What data-related topics do you feel are most important to patients, or have the most impact on patients/patient health? Input will be used to help develop themes/topics for future webinars and discussions. Data access and security. Data re-use and integration (across providers and payers). Understanding the privacy risks. From the standpoint of the autism community my personal feeling is that practically everything needs to be addressed in patient/family education or awareness; what Big Data represents, why it could be important for research that supports not only therapies but community-based services, an understanding of choices on safeguarding consent and privacy, etc. I m very anxious to see community members get better educated on why new forms of data may prove to be so important: patient-reported outcomes data, patient-centered outcomes data, etc. I think the balance of privacy of EMR along with access to EMR for research purposes is key. I think it is important to flush out the details of how the data can be accessed by patient advocates that have an interest and/or background in data. I think patients are often concerned with privacy and want to know exactly what their information will be used for...in my pathophysiology course we often talk about how people are scared to participate in studies because they don t want things to possibly interfere with health insurance or job status. Our population often doesn t understand the basics behind their treatments and hospital experiences. We need to make sure that the explanations given to them about big data involve clear, simple terminology. We need to adapt the methods to relate to the many different groups that we will encounter (racial, socio-economic, etc.). A big emphasis needs to be on properly communicating to your target audience to best educate them. Responses to Please share any additional comments, questions, or hop eful outcomes for this program. Empower patients and advocates to own their data and put it to use for themselves and the benefits of the public. I think it s important to involve academics from all areas, not just a specific disease type of non-profit. I m an advocate who had a rarer form of cancer and am often excluded from opportunities. I also am not officially associated with a single non-profit, so that often works against me. Look at people with experience and a wide array of knowledge to help with your program. Stakeholder Engagement Plan 9