An electronic practice-based network for observational comparative effectiveness research.

The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health data from 8 organizations representing more than 500 clinicians and more than 400 000 patients. DARTNet was designed to increase knowledge of the comparative effectiveness of prescription medications and medical devices. Traditional observational comparative effectiveness research is conducted using large data sets, such as claims databases. Such databases do not provide important clinical information that is critical to understanding comparative effectiveness. By linking electronic health records, laboratory and imaging data, and administrative data from diverse and geographically disparate patients, DARTNet provides important new insight into the comparative effectiveness of oral diabetes medications, and it is ready for expansion to further enable effectiveness research.

Do professional development programs for Maintenance of Certification (MOC) affect quality of patient care?

OBJECTIVE: The objective of this study was to examine the relationship between physicians' completion of American Board of Family Medicine (ABFM) Maintenance of Certification (MOC) modules and the quality of medical care delivered. METHODS: Physicians from the Electronic National Quality Improvement and Research Network (eNQUIRENet) were enrolled. Data from their electronic health records were compared before and after they completed one or more MOC modules for family physicians (Self-Assessment Module [Part II MOC] and Performance in Practice Module [Part IV MOC]; SAM/PPM). Process data and other quantitative clinical measures for all adult patients with a diagnosis of type 2 diabetes were gathered from each study physician. General linear mixed effects models were used to analyze data before and after the MOC modules, adjusting for clustering of patients within physicians. RESULTS: Physicians participating in SAM/PPM activities demonstrated greater improvements over time in 11 of 24 measures in process and intermediate outcome measures related to type 2 diabetes care compared with non-SAM/PPM participants. All groups demonstrated improvements over time. CONCLUSION: Participation in SAM/PPM activities is associated with greater improvements in care, but the association between activity undertaken and specific improvements is difficult to demonstrate.

Practice-based research network studies and institutional review boards: two new issues.

BACKGROUND: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. OBJECTIVE: To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. RESULTS: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. CONCLUSIONS: IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.