Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.

Athletic amenorrhea and endothelial dysfunction.

OBJECTIVES: To determine if menstrual status changed in amenorrheic college runners over a 2-year period and what effect this had on brachial artery flow-mediated dilation. PARTICIPANTS: Eighteen athletes first studied in our laboratory 2 years prior were available for follow-up. Nine of the 10 original women with athletic amenorrhea (mean +/- SE, age 21.3 +/- 1.2 yrs), and 9 of the 11 eumenorrheics/controls (age 20.1 +/- 0.5 yrs) were studied 2 years after baseline measurements. METHODS: Questionnaires/personal interviews and blood draws were performed to determine menstrual status. A non-invasive ultrasound technique was used to determine brachial artery flow-mediated dilation (endothelium-dependent). RESULTS: Menstrual status changed in 7 of 9 original amenorrheic subjects (2 were taking hormone replacement, 2 were taking oral contraceptives, 3 had a natural menstrual period prior to testing, and 2 remained amenorrheic). Endothelium-dependent brachial artery dilation, measured as the percent change in maximal brachial artery diameter from baseline during reactive hyperemia, was improved in the original amenorrheic subjects (a 1.1% +/- 1.0 increase in the original study versus 5.6% + 1.1 increase in the current study, P=0.01) while in the eumenorrheic/control group there was no change (6.3% +/- 1.7 versus 8.0% +/- 1.3, P=0.42). CONCLUSIONS: Menstrual status changed in 7 of the 9 original amenorrheic athletes, and this change was associated with an improvement in brachial artery flow-mediated dilation.

Perceptual voice analysis of patients with subglottic stenosis.

OBJECTIVES: To characterize the perceptual assessment of vocal quality in subglottic stenosis (SGS) patients and to identify risk factors for dysphonia. STUDY DESIGN AND SETTING: Retrospective review, academic center. METHODS: Perceptual voice assessment using GRBAS scale (Grade, Roughness, Breathiness, Asthenia, Strain); patient characteristics determined for 31 SGS cases. RESULTS: The mean GRBAS (0 to 3 scale, 0 = normal quality) for SGS patients at their initial visit was G(1.4)R(1.2)B(0.5)A(0.5)S(1.1). For males vs females: G(2.1 vs 1.1)R(2.0 vs 0.8)B(1.0 vs 0.4)A(1.0 vs 0.3)S(1.7 vs 0.9). The Grade (P < 0.03), Breathiness (P < 0.04), and Asthenia (P < 0.02) assessments were significantly more dysphonic in patients with multilevel stenosis; vocal fold motion impairment (VFMI) also impacted overall Grade (P < 0.01). Overall Grade (P < 0.002), Roughness (P < 0.007), and Breathiness (P < 0.006) were significantly worse in patients with prior airway surgery. CONCLUSION: SGS patients demonstrate a mild to moderate change in perceptual voice characteristics with males in this series being more affected than females. Negative risk factors include multiple stenoses, VFMI, and previous airway surgery. SIGNIFICANCE: This is the first systematic report of perceptual voice assessment in subglottic stenosis. SGS patients have notable degrees of dysphonia with identifiable risk factors.

Operationalizing quality improvement in a pediatric surgical practice.

BACKGROUND/PURPOSE: Quality improvement (QI) is critical to enhancing patient care. It is necessary to prioritize which QI initiatives are relevant to one's institution and practice, as implementation is resource-intensive. We have developed and implemented a streamlined process to identify QI opportunities in our practice. METHODS: We designed a web-based Pediatric and Infant Case Log and Outcomes (PICaLO) instrument using Research Electronic Data Capture (REDCap™) to record all surgical procedures for our practice. At the time of operation, a surgeon completes a case report form. An administrative assistant enters the data in PICaLO within 5-7days. Outcomes such as complications, deaths, and "occurrences" (readmissions, reoperations, transfers to ICU, ER visit, additional clinic visits) are recorded at the time of encounter, during M & M Conferences, and during follow-up clinic visits. Variables were chosen and defined based on national standards from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP), and Patient Based Learning Log. Occurrences are queried for potential QI initiatives. RESULTS: In 2012, 3597 patients were entered, totaling 5177 procedures. There were 220 complications, 278 occurrences, and 16 deaths. Specific QI opportunities were identified and put into place. CONCLUSION: Data on procedures and outcomes can be collected effectively in a pediatric surgery practice to delineate pertinent QI initiatives. PICaLO is recognized by the American Board of Surgery as a mechanism to meet Maintenance of Certification 4 criteria.