Fabrication and In Vivo Assessment of Oxidatively Responsive PolyHIPE Scaffolds for Use in Diabetic Orthopedic Applications.

Achieving surgical success in orthopedic patients with metabolic disease remains a substantial challenge. Diabetic patients exhibit a unique tissue microenvironment consisting of high levels of reactive oxygen species (ROS), which promotes osteoclastic activity and leads to decreased bone healing. Alternative solutions, such as synthetic grafts, incorporating progenitor cells or growth factors, can be costly and have processing constraints. Previously, the potential for thiol-methacrylate networks to sequester ROS while possessing tunable mechanical properties and degradation rates has been demonstrated. In this study, the ability to fabricate thiol-methacrylate interconnected porous scaffolds using emulsion templating to create monoliths with an average porosity of 97.0% is reported. The average pore sizes of the scaffolds range from 27 to 656 µm. The scaffolds can sequester pathologic levels of ROS via hydrogen peroxide consumption and are not impacted by sterilization. Subcutaneous implantation shows no signs of acute toxicity. Finally, in a 6-week bilateral calvarial defect model in Zucker diabetic fatty rats, ROS scaffolds increase new bone volume by 66% over sham defects. Histologic analysis identifies woven bone infiltration throughout the scaffold and neovascularization. Overall, this study suggests that porous thiol-methacrylate scaffolds may improve healing for bone grafting applications where high levels of ROS hinder bone growth.

Continuity of public insurance coverage: a systematic review of the literature.

Publicly financed insurance programs are tasked with maintaining coverage for eligible children, but published measures to assess coverage have not been evaluated. Therefore, we sought to identify and categorize measures of health insurance continuity for children and adolescents. We conducted a systematic review of Medline and HealthStar databases, review of reference lists of eligible articles, and contact with experts. We categorized measures into 8 domains based on a conceptual framework. We identified 147 measures from 84 eligible articles. Most measures evaluated the following domains: always insured (41%), repeatedly uninsured (36%), and transition out of coverage (29%), while fewer assessed single gap in coverage, always uninsured, transition into coverage, change in coverage, and eligibility. Only 18% of measures assessed associations between continuity of coverage and child and adolescent health outcomes. These results suggest that a number of measures of continuity of coverage exist, but few measures have assessed impact on outcomes.

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006). CONCLUSIONS: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited. Please see later in the article for the Editors' Summary.