Developing a distributed research network to conduct population-based studies and safety surveillance (original) (raw)
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Distributed Health Data Networks
Medical Care, 2010
Background: Comparative effectiveness research, medical product safety evaluation, and quality measurement will require the ability to use electronic health data held by multiple organizations. There is no consensus about whether to create regional or national combined (eg, "all payer") databases for these purposes, or distributed data networks that leave most Protected Health Information and proprietary data in the possession of the original data holders. Objectives: Demonstrate functions of a distributed research network that supports research needs and also address data holders concerns about participation. Key design functions included strong local control of data uses and a centralized web-based querying interface. Research Design: We implemented a pilot distributed research network and evaluated the design considerations, utility for research, and the acceptability to data holders of methods for menu-driven querying. We developed and tested a central, web-based interface with supporting network software. Specific functions assessed include query formation and distribution, query execution and review, and aggregation of results. Results: This pilot successfully evaluated temporal trends in medication use and diagnoses at 5 separate sites, demonstrating some of the possibilities of using a distributed research network. The pilot demonstrated the potential utility of the design, which addressed the major concerns of both users and data holders. No serious obstacles were identified that would prevent development of a fully functional, scalable network. Conclusions: Distributed networks are capable of addressing nearly all anticipated uses of routinely collected electronic healthcare data. Distributed networks would obviate the need for centralized databases, thus avoiding numerous obstacles.
Extending the clinical research network approach to all of healthcare
Annals of Oncology, 2011
a high-quality peer-reviewed portfolio of studies. The success of the National Cancer Research Network is summarized in Chapter 5. In this chapter progress in five other topics, and more recently in primary care and comprehensively across the NHS, is summarized. In each of the 'topic-specific' networks (Dementias and Neurodegenerative Diseases, Diabetes, Medicines for Children, Mental Health, Stroke) there has been a rapid and substantial increase in portfolios and in the recruitment of patients into studies in these portfolios. The processes and the key success factors are described. The CRN have worked to support research supported by pharmaceutical, biotechnology and medical device companies and there has been substantial progress in improving the speed, cost and delivery of these 'industry' studies. In particular, work to support the increased speed of set up and delivery of industry studies, and to embed this firmly in the NHS, was explored in the North West of England in an Exemplar Programme which showed substantial reductions in study set-up times and improved recruitment into studies and showed how healthcare (NHS) organizations can overcome delays in set up times when they actively manage the process. Seven out of 20 international studies reported that the first patient to be entered anywhere in the world was from the UK. In addition, the CRN have supported research management and governance, workforce development and clinical trials unit collaboration and coordination. International peer reviews of all of the CRN have been positive and resulted in the continuation of the system for a further 5 years in all cases.
Journal of the American Board of Family Medicine : JABFM
There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, an...
Infrastructure Requirements for Practice-Based Research Networks
The Annals of Family Medicine, 2005
BACKGROUND The practice-based research network (PBRN) is the basic laboratory for primary care research. Although most PBRNs include some common elements, their infrastructures vary widely. We offer suggestions for developing and supporting infrastructures to enhance PBRN research success. METHODS Information was compiled based on published articles, the PBRN Resource Center survey of 2003, our PBRN experiences, and discussions with directors and coordinators from other PBRNs. RESULTS PBRN research ranges from observational studies, through intervention studies, clinical trials, and quality of care research, to large-scale practice change interventions. Basic infrastructure elements such as a membership roster, a board, a director, a coordinator, a news-sharing function, a means of addressing requirements of institutional review boards and the Health Insurance Portability and Accountability Act, and a network meeting must exist to support these initiatives. Desirable elements such as support staff, electronic medical records, multiuser databases, mentoring and development programs, mock study sections, and research training are costly and diffi cult to sustain through project grant funds. These infrastructure elements must be selected, confi gured, and sized according to the PBRN's self-defi ned research mission. Annual infrastructure costs are estimated to range from 69,700forabasicnetworkto69,700 for a basic network to 69,700forabasicnetworkto287,600 for a moderately complex network. CONCLUSIONS Well-designed and properly supported PBRN infrastructures can support a wide range of research of great direct value to patients and society. Increased and more consistent infrastructure support could generate an explosion of pragmatic, generalizable knowledge about currently understudied populations, settings, and health care problems.
Institutional Review Board Approval of Practice-based Research Network Patient Safety Studies
2005
Background: Institutional review board (IRB) approval of research that involves the collection of medical error reports is a major challenge. The process includes issues of confidentiality, privacy, discoverability, informed consent, and Web site security. The challenges are more complex for multisite research. This paper describes the approaches taken by the American Academy of Family Physicians (AAFP) and the University of Colorado (CU) to address the challenges and barriers created by the IRB approval process for multisite patient safety research studies. Methods: Between 2001 and 2004, the AAFP and CU conducted several patient safety studies involving primary care practices in three practice-based research networks (PBRNs). The AAFP conducted two pilot studies in 18 primary care clinics in which error reports were submitted by physicians, staff, and patients. The AAFP sought approval from 15 different IRBs for these studies. CU conducted a 3-year project that collected medical errors from 38 primary care practices affiliated with seven separate IRBs. Results: AAFP successfully obtained approval from all 15 IRBs. Several sites required approval from risk management and legal departments. CU obtained approval for the primary study from seven IRBs and two hospital research committees. Secondary studies required additional approvals. Overall, the two projects had a high level of success in obtaining IRB approval. There was great variation in submission requirements, level of review, length of time to obtain approval, and required revisions. Conclusion: PBRN research often includes atypical, multisite research activity, with practices simultaneously serving as research subjects and investigators. The high-risk nature of patient safety work further complicates this situation. Investigative work with the Office for Human Research Protections and the Agency for Healthcare Research and Quality to create a central IRB process could greatly facilitate work of this nature.
Towards a “Just-in-Time” Distributed Decision Support System in Health Care Research
Annals of Information Systems, 2010
The application of semi-automated decision support systems in health care faces challenging tasks mainly in generating evidence-based recommendations in a short critical time window. Traditional data collection and survey methodology to generate evidence for the decision support systems also suffers from a slow turnaround time. This chapter reports on a multidisciplinary project between computer and health sciences to introduce a cumulative framework encapsulating innovative distributed data collection methodology, coupled with an intelligent multiagent, socially driven decision support system. We report on the current design and implementation aspects of this integrated system with a case study in injury prevention to verify the initial model.
Therapeutic innovation & regulatory science, 2013
Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.