The National Patient-Centered Clinical Research Network (PCORnet) has recently made a draft protocol for its first randomized clinical trial available for stakeholder review. Researchers, clinicians, patients and the public are all invited to read the current draft of the study protocol and provide comments and feedback.
The ADAPTABLE Study (PDF), which will investigate whether lower- or higher-dose aspirin is better for preventing heart attack and stroke in patients at risk for heart disease, is PCORnet’s first randomized pragmatic clinical trial. Designed to leverage PCORnet’s Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs), the trial will serve as twofold purpose: answering a clinical question of direct importance for patients, families, and healthcare providers, and serving as a demonstration of PCORnet’s capabilities in conducting clinical research on a national scale.
Links to the proposed study protocol, a survey tool for capturing feedback, and other information about ADAPTABLE Study, including press releases, fact sheets, and infographics, are available at the link below:
ADAPTABLE: The Aspirin Study
Follow PCORnet on Twitter @PCORnetwork for updates on the ADAPTABLE #ClinicalTrial
An explosion in the collection of personal data is fostering concerns about the extent to which health information is accessed—and about the privacy and confidentiality of this information. Two recent National Public Radio stories highlight a few of the burgeoning uses of these abundant data.
In the first, an insurer uses personal data to predict who will get sick so it can identify patients at highest risk for hospital admission, or readmission, and then provide them with personal health coaches. The coordinated care given to patients by the coaches (for example, arranging a visiting nurse or streamlining appointments) has been shown to improve hospitalization rates. The insurer says it follows federal health privacy guidelines for anonymity and uses the information to better serve its members.
The second story explains that results of online health searches aren’t always confidential, and data brokers are tracking information and selling it to interested parties. The author notes that data gathered on the Web are, for the most part, unregulated. Both stories raise questions about privacy and confidentiality of health information and how to best protect it.
Pragmatic clinical trials also seek to use personal health data to answer important questions on the risks, benefits, and burdens of therapeutic interventions. In a blog post in Health Affairs, Joe Selby, executive director of the Patient-Centered Outcomes Research Institute (PCORI), underscores the need for trust, support, and active engagement of patients when involving them in health data research, even with privacy protections in place. PCORI has launched the National Patient-Centered Clinical Research Network (PCORnet) as a means of harnessing large clinical data sets to study the comparative effectiveness of treatments, and a central tenet of the network is that patients, clinicians, and healthcare systems should be actively involved in the governance of the use of health information.
Read the full articles
From NPR: Insurer Uses Personal Data To Predict Who Will Get Sick
From NPR: Online Health Searches Aren't Always Confidential
From Health Affairs: Advancing the Use of Health Data in Research With PCORnet
The Patient-Centered Outcomes Research Institute (PCORI) has approved the first pragmatic clinical trial to be performed through the National Patient-Centered Clinical Research Network (PCORnet)—the ADAPTABLE study (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness).
Over the course of the trial, 20,000 study participants with cardiovascular disease will be randomly assigned to receive one of two commonly used doses of aspirin—a low dose of 81 mg per day versus a higher dose of 325 mg per day—in order to determine which provides the optimal balance between protecting patients with cardiovascular disease from heart attack and stroke, and minimizing bleeding events associated with aspirin therapy. The trial will also employ a number of innovative methods, including electronic health record (EHR)-based data collection and a patient-centered, web-based enrollment model in partnership with the Health eHeart Alliance Patient-Powered Research Network (PPRN).
The ADAPTABLE trial, which includes six of PCORnet’s Clinical Data Research Networks (CDRNs), will be led and coordinated through the Duke Clinical Research Institute (DCRI).
Read more about the ADAPTABLE Aspirin Trial here:
Fact Sheet (PDF)
DCRI Coordinating Center Announcement
A new study examining public attitudes about the sharing of personal medical data through health information exchanges and distributed research networks finds a mixture of receptiveness and concerns about privacy and security. The study, conducted by researchers from the University of California, Davis and University of California, San Diego and published online in the Journal of the American Medical Informatics Association (JAMIA), reports results from a telephone survey of 800 California residents. Participants were asked for their opinions about the importance of sharing personal health data for research purposes and their feelings about related issues of security and privacy, as well as the importance of notification and permission for such sharing.
The authors found that a majority of respondents felt that sharing health data would “greatly improve” the quality of medical care and research. Further, many either somewhat or strongly agreed that the potential benefits of sharing data for research and care improvement outweighed privacy considerations (50.8%) or the right to control the use of their personal information (69.8%), although study participants also indicated that transparency regarding the purpose of any data sharing and controlling access to data remained important considerations.
However, the study’s investigators also found evidence of widespread concern over privacy and security issues, with substantial proportions of respondents reporting a belief that data sharing would have negative effects on the security (42.5%) and privacy (40.3%) of their health data. The study also explored attitudes about the need to obtain permission for sharing health data, as well as whether attitudes toward sharing data differed according to the purpose (e.g., for research vs. care) and the groups or individuals among which the data were being shared.
The authors note that while data-sharing networks are increasingly viewed as a crucial tool for enabling research and improving care on a national scale, they ultimately rely upon trust and acceptance from patients. As such, the long-term success of efforts aimed at building effective data-sharing networks may depend on accurately understanding the views of patients and accommodating their concerns.
Read the full article here:
Kim KK, Joseph JG, Ohno-Machado L. Comparison of consumers' views on electronic data sharing for healthcare and research. J Am Med Inform Assoc. 2015 Mar 30. pii: ocv014. doi: 10.1093/jamia/ocv014. [Epub ahead of print]
Recently the journal Health Affairs and the Patient-Centered Outcomes Research Institute (PCORI) conducted a Twitter chat on the topic of patient engagement in research. The chat was an hour-long moderated question-and-answer session with Susan Sheridan, the director of patient engagement at PCORI. Participants joined the conversation via #PatientHC and talked about what patient engagement looks like and concerns about the privacy of patient health data.
The hosts referenced the journal’s 2013 theme issue on patient engagement as well as three videos produced in partnership with PCORI that illustrate ways patients and providers are incorporating patient engagement in healthcare decisions. An archived version of the Twitter chat is here.
The Institute of Medicine (IOM) has released a new report, Integrating Research and Practice: Health System Leaders Working Toward High-Value Care: Workshop Summary. The report summarizes the presentations and discussions from two meetings held in April and June 2014 by the IOM’s Roundtable on Value & Science-Driven Health Care, with sponsorship from the Patient-Centered Outcomes Research Institute (PCORI).
The workshops brought together health system leaders and researchers to discuss partnerships for progress toward a learning healthcare system in which the continuous generation of knowledge informs better care. Attendees identified challenges and established priorities in integrating clinical research into healthcare delivery systems. There was a particular focus on the recently established National Patient-Centered Clinical Research Network (PCORnet).
View the Workshop Summary
(Note: The workshop summary contains the opinions of the workshop presenters and does not reflect conclusions of the IOM.)
The meeting of the Secretary’s Advisory Committee for Human Research Protections (SACHRP) scheduled for July 21-22, 2014, will include a session on “Regulatory Issues Concerning Big Data.” Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), will speak, along with leaders from the NIH and FDA. The session is scheduled for 1:30-3:45 pm on Monday, July 21.
SACHRP provides recommendations on human subjects protection to the Secretary of the U.S. Department of Health and Human Services and reviews activities of the Office for Human Research Protections (OHRP). Other topics to be covered during the two-day meeting include informed consent comprehension, the return of research results to human subjects, and ethical/regulatory issues in interventional social media research.
The meeting is available to the public and will be videocast live.
View the meeting agenda
View the live webcast (available July 21-22, 2014)
A link to materials from the meeting will be provided in an update to this post when available.
A new Living Textbook topic chapter, “Learning Healthcare Systems,” has just been published. The topic includes background information on the creation and evolution of the concept of the learning healthcare system and the key attributes that define such systems, as described by the Institute of Medicine:
A learning healthcare system is [one that] is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care .
Also included in the topic chapter are ethical and regulatory implications for learning healthcare systems, patient and public engagement, the application of electronic heatlh records and other information technology, logistical and organizational challenges to bulding learning healthcare systems, and early examples of such systems in practice.
1. Institute of Medicine. The Learning Healthcare System: Workshop Summary. Olsen L, Aisner D, McGinnis JM, eds. Washington, DC: National Academies Press; 2007. Available at: http://www.iom.edu/Reports/2007/The-Learning-Healthcare-System-Workshop-Summary.aspx. Accessed April 4, 2014.
Slides and a workshop summary are now available from the Institute of Medicine website.
On April 23-24, 2014, the Institute of Medicine held a Roundtable on Value & Science-Driven Health Care workshop titled “Health System Leaders Working Towards High Value Care Through Integration of Care and Research” in Washington, DC. The workshop, sponsored by the Patient-Centered Outcomes Research Institute (PCORI), brought together stakeholders from across research networks, health systems, industry, and the patient community to engage on barriers and opportunities in building a continuously learning health system, where routinely collected health data informs improvements in evidence-based care. Eric Larson, MD, MPH, of the Group Health Research Institute chaired the workshop Planning Committee.
Workshop goals included:
- Fostering the development of a shared commitment, vision, and strategy among health system leaders building a national clinical research network
- Broadening and deepening health systems’ leadership awareness of the prospects for and from a continuously learning health system
- Learning from models and examples of productive integration of research with care delivery programs
- Identifying common issues compelling to health systems leaders related to science, technology, ethics, regulatory oversight, business, and governance
- Exploring strategic opportunities for executive, clinical, and research leaders to forge working partnerships for progress
- Considering the approach and desirable outcomes of a meeting of CEO leaders vital to building and sustaining a functional, real-time national clinical research network
One particular focus of the meeting was the recently launched National Patient-Centered Clinical Research Network (PCORnet). Workshop participants included representatives from PCORnet’s Clinical Data Research Networks and Patient-Powered Research Networks. Speakers provided real-world examples of learning health systems and urged leaders to make a business case for the learning health system model. Speed and dissemination of research were discussed as important considerations for patients.
The meeting was open to the public via webcast. Archived meeting presentations will be made available; a link will be provided in an update to this post. Workshop-related tweets can be found with the hashtag #IOMPCORI.
View the workshop agenda and briefing materials.
On Thursday, April 17, The Diane Rehm Show, a nationally syndicated news and call-in program carried on National Public Radio, aired a program titled The Promise and Perils of a New Project to Share Individual Patient Records. Susan Page of USA Today led the discussion on PCORnet: the National Patient-Centered Clinical Research Network, which is supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Joe Selby, the executive director of PCORI, describes how PCORnet will take advantage of the incredible quantity of clinical information in electronic health records to conduct much-needed research on the relative effectiveness of different medical devices, drugs, and other medical therapies. Click here for a transcript of this program, or listen to the full episode below:
Listen now: The Promise and Perils of a New Project to Share Patient Records