Big Data Research Requires a Big Role for Primary Care

摘要

The use of big data is raising big expectations for medical research and big questions for primary care practices, patients, and researchers. The ever increasing mass of data that are routinely collected in clinical databases has been heralded as the tool for research to revolutionize the delivery of health care.1-3 The business of health care also expects substantial returns in efficiency and profitability from applying big data to the management of clinicians and services.4 As of late 2013, 86% of US hospitals had adopted electronic health records (EHR), and over 200,000 physicians and other individual providers reported using an EHR system in their practices.5 Some envision a future where all patients are research subjects, and every visit is part of a research protocol. Many worry about what happens to all this data once it gets out of the hands of the patients and those who care for them.The increasing ease with which EHRs and other routinely collected data can be aggregated and accessed has brought to the forefront discussions about ethics and patient privacy.6 The US Office of Human Subject Protections is proposing changes to the common rule that governs institutional review boards that would require patients to give informed consent for more of the data that is now routinely collected in the process of their care. These proposed changes have drawn both positive and negative responses from researchers, health plans, and advocacy groups.7-9Primary care researchers and leaders must join in this discussion to protect our patients, empower our clinicians, and advance our research. To be comprehensive, data must be collected at the point of care for each patient encounter with the health care system. Thus, the biggest share of such data must be collected in primary care, where most people get most of their care for most of their problems most of the time. Genuine engagement of primary care clinicians and practices is also a key strategy in the recruitment of representative patients and in particular underrepresented minorities.A critical concern about big data—so far missing from these discussions—is the importance of patient trust in the research process and the critical role of primary care in building and protecting that trust. To grow and sustain the potential of the big data research enterprise, systems must be designed to protect patients and preserve trust in primary care.Prior research has established the importance of trust in people’s willingness to participate in research and in their assessment of risk information.10-12 Public attitudes toward release of EHR data for research are strongly influenced by the perceived social value and purpose of studies.13 Although patients are generally positive about medical research they are concerned about the blurring of lines between research and clinical practice.14,15 However, they do want their doctor to tell them if their records are going to be used for research. For example, 59% of patients have reported that being informed that their medical records were being used in research would somewhat or greatly increase their trust in their doctor.14 Specifically, patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks.16Primary care clinicians can play a key role in establishing patients’ trust in medical research at the point of care. Moreover, we know that physicians tend to act as proxies and protectors of their patients when it comes to trust in medical researchers.17 Some of the changes proposed to the Institutional Review Board common rule would require more patient consent and are based on the contention that they will increase patient trust in research.As the professionals working at the nexus of care and data collection, primary care clinicians will shoulder the burden of discussing with patients the risks and benefits of research with their data, including protections in future big dat