Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Clinical research protocols are intricate and detailed. Regulatory authorities including the U.S. Food and Drug Administration require full documentation of all procedures, including who performed them and when they were performed. Paper based study records are becoming ever more voluminous as the requirements for detailing every item continue to grow. Although the current approach is to transfer required data to electronic databases, each protocol requires uniquely designed databases. Therefore, at present, it has not been possible to design generalized electronic databases which serve for each individual study which can serve as primary source documentation. We have taken a new approach, by developing an electronic graphically based source documentation technology which in every way mimics and maintains the advantages of paper recordkeeping. We use tablet computers as paper surrogates, feeding data archives maintained on central servers. Our system uses widely available non-proprietary components and programs. We meet the requirements enunciated by the US Food and Drug Administration for electronic systems. These include requirements to maintain data integrity, backup of data, validation of all system components, safeguards on digital signatures, and a date and time stamped audit trail. This system has been used by our group successfully for more than 2 years encompassing over 20 pharmaceutical research studies.

Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6-and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment.Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional effort s to improve the outcomes of these challenging injuries are still needed.

Introduction/Purpose: Pre-operative serum albumin levels have routinely been utilized to assess nutritional status. Malnutrition, as defined by serum albumin levels < 3.5 g/dL, has been associated with worse post-operative outcomes in multiple surgical settings. The effect of hypo-albuminemia on 30-day post-operative outcomes after operative fixation of ankle fractures has not been well delineated.