Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) rely on evidence from clinical trials when approving a therapeutic for marketing and insurance coverage in the US, respectively. No study has compared the quality and quantity of evidence examined by these agencies.To characterize evidence used by FDA and CMS to support marketing approval and National Coverage Determinations (NCDs), respectively, of novel therapeutics reviewed for CMS coverage from 2005 through 2016.A cross-sectional study of clinical trials described in FDA approval documents and CMS NCD memoranda. We compared the number of clinical trials used by each agency as well as the following characteristics among original clinical trials: study size, randomization, double-blinding, and control arm.Twelve medical products met our inclusion criteria. FDA approvals of these products were based on 22 pivotal trials. CMS NCDs were based on 27 original clinical trials; 14 clinical trials were used by both agencies. Between FDA pivotal and CMS original clinical trials, there was no significant difference in study size (P = .53), use of randomization (P = .75), double-blinding (P = .55), or control arm (P = .54). There was no statistically significant difference in median age between participants in trials reviewed by CMS versus those reviewed by FDA (62 vs 59 years, P = .26). The median time from FDA approval to publication of CMS NCD memorandum was 17 (interquartile range, 13–36) months.FDA approvals and CMS NCDs are based on a similar number and quality of trials, although trial participants are not reflective of the Medicare population, and the process of finalizing coverage determinations requires an additional 17 months.

Nonsteroidal anti-inflammatory drugs (NSAIDs; 1) are widely recommended for several acute and chronic conditions. For example, both indomethacin and aspirin are taken for pain relief. Aspirin is also used for prevention of myocardial infarction, and indomethacin can be administered orally or as a suppository for patients with rheumatoid disease and other chronic inflammatory states. However, use of NSAIDs can cause damage to the mucosal barrier surrounding the gastrointestinal (GI) tract, increasing the risk of ulcer formation. While microencapsulation of NSAIDs has been shown to reduce upper GI injury, sustained release in the lower GI tract and colon may cause epithelial erosion due to increased acidification. The use of suppositories has also been linked to rectal and lower GI bleeding. In this study, we investigated the role of NSAIDs aspirin and indomethacin on Na+/H+ exchanger (NHE) activity in rat colonic crypts. By comparing average rates of pH recovery between control and NSAID perfusion runs, we were able to determine that both aspirin and indomethacin increase hydrogen extrusion into the colonic lumen. Through treatment with 5-ethylisopropyl amiloride (EIPA), amiloride, and zoniporide dihydrochloride, we further demonstrated that indomethacin specifically enhances proton excretion through regulation of apical NHE-3 and NHE-2 and to a lesser extent on basolateral NHE-1 and NHE-4. Our results suggest that clinical exposure to NSAIDs may affect colonic tissue at the site of selected NHE isoforms, resulting in modulation of transport and barrier function.

The transition to parenthood marks a significant developmental period for the mother. Clinical and preclinical studies evidence neural and hormonal changes that support maternal behavior that is critical to infant survival and development. These changes suggest marked plasticity as a result of reproduction in the mother. Furthermore, multiple reproductive experiences may contribute to long‐lasting changes to support more efficient and competent caregiving with subsequent pregnancies and births. However, less is known about neural, hormonal, and behavioral changes that occur as a function of parity—the number of children a woman has. Here, we highlight behavioral, neural, and hormonal changes that occur as women transition to parenthood, with a special emphasis on parity‐related changes. Limitations and directions for future research are discussed, as well as clinical implications to be considered in light of parity research.

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Background Sutureless ophthalmic procedures are becoming more commonplace, reducing opportunities for ophthalmology residents to learn microsurgical suturing techniques. There is no standard curriculum in place to address this gap in clinical training among ophthalmology residency programs. Objective The aim of this study was to design, implement, and evaluate a preliminary microsurgical suturing curriculum for ophthalmology residents using Kern's six-step approach for curriculum development as a guideline, and the principles of distributed practice and guided, self-directed practice. Methods We designed a faculty-led teaching session on fundamental microsurgical suturing techniques for all 15 ophthalmology residents from Yale University over one academic year. Suturing skills were evaluated, followed by a guided teaching session, 30 days of self-directed practice time, and a re-evaluation of skills. The residents were evaluated through a written knowledge assessment and practical skills assessment. The residents also evaluated their skill level before and after the teaching session and practice period through written Likert-scale surveys. Data were evaluated in Excel using descriptive statistics and the paired t-test. Results After the session, postgraduate year 2 (PGY-2) residents felt more confident in recognition and use of surgical instruments (p < 0.01). PGY-3 residents felt less confident in their knowledge of microsurgical suturing after the session (p = 0.02). PGY-4 residents felt they were better able to identify different suture types after the session (p = 0.02). All residents improved on the written knowledge assessment (p < 0.001) and in all categories of the practical skills assessment (p < 0.001). Conclusions Implementation of a faculty-led microsurgical suturing training session, followed by 1-month of practice time, significantly improved residents' knowledge and practical application of various microsurgical suturing techniques that are necessary for performing common ophthalmic procedures.