IRB reliance: An informatics approach.

Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.

Office-Based Carpal Tunnel Release With Ultrasound Guidance: 6-month Outcomes From the Multicenter ROBUST Trial.

Purpose: The purpose of this study was to determine the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US). Methods: In this prospective multicenter observational study, patients were treated with CTR-US in an office setting. Outcomes were time to resume normal daily activities, time to return to work, Boston Carpal Tunnel Questionnaire Symptom Severity Scale and Functional Status Scale scores, Michigan Hand Questionnaire, Numeric Pain Scale, EuroQoL-5 Dimension 5-Level score, procedure satisfaction, and adverse events over 6 months. Results: A total of 149 participants (226 hands) from seven centers underwent office-based CTR-US. The mean age was 58 years, 52% were women, and 68% were employed. The mean incision length was 5 mm, 52% had simultaneous bilateral procedures, and wide-awake local anesthesia no tourniquet was used in all cases. All procedures were completed as planned, with no conversions to open repair and mean intraoperative pain severity of 1.6 ± 1.5. The median time to resume normal activities was 2 days (interquartile range: 1-4 days) and return to work was 4 days (interquartile range: 1-5 days). Over 6 months, Boston Carpal Tunnel Questionnaire Symptom Severity Scale decreased by a mean of 1.7 points, Boston Carpal Tunnel Questionnaire Functional Status Scale decreased by 1.1 points, Michigan Hand Questionnaire Global score increased by 35 points, Numeric Pain Scale decreased by 3.7 points, and EuroQoL-5 Dimension 5-Level score increased by 0.11 points. At 6 months, 94% reported procedure satisfaction. Unilateral and simultaneous bilateral procedures were similarly effective. There was one (0.4%) adverse event, a nerve contusion treated with neurolysis and nerve wrap where the patient fully regained normal function within 7 weeks. There were no revisions for persistent or recurrent carpal tunnel syndrome symptoms. Conclusions: Office-based CTR-US, performed either unilaterally or as simultaneous bilateral procedures, is well tolerated with a low complication rate and associated with rapid recovery, sustained improvement in symptoms and function, and high procedure satisfaction. Type of study/level of evidence: Therapeutic III.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents.

BACKGROUND: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. PURPOSE: The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow. METHODS: The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. RESULTS: An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. LIMITATIONS: There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. CONCLUSIONS: We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.

Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

The extensor pollicis brevis entrapment test in the treatment of de Quervain's disease.

Isolation of the extensor pollicis brevis (EPB) tendon in a separate compartment has been reported to contribute to the pathogenesis of de Quervain's disease and affect the patient's response to nonsurgical treatment. The EPB entrapment test was developed to evaluate the patient with de Quervain's disease. The purpose of this study was to compare the results from this preoperative test with the anatomic findings at surgery in patients who failed nonsurgical treatment. One hundred seventy-eight patients who were treated for de Quervain's disease (200 wrists) were asked to compare the amount of pain elicited by firm resistance with thumb metacarpophalangeal joint extension with that from resistance to palmar abduction. Twenty-six wrists (13%) had surgical release after failure of nonsurgical treatment. Of those having surgery the proportion of wrists with a positive EPB entrapment test was significantly higher among those with 2 compartments (18 of 22) than among those with 1 compartment (0 of 4) (Fisher's exact test). In the surgical group the EPB entrapment test showed 81% sensitivity and 50% specificity in identifying wrists with a separate EPB compartment.