: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and skin test reagent as a novel adjuvant.: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 μg per peptide). : The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 μg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations ( = 0.02). : This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that which induces interleukin-12 (IL-12) , may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.
Objective To determine maternal fetal medicine (MFM) referral trends in a Medicaid population over time. Study Design Sixteen clinical guidelines and 23 clinical conditions were identified where co-management/consultation with MFM specialist is recommended. Linked Medicaid claims and birth certificate data for 2001–2006 were used to identify pregnancies with these conditions and whether they received co-management/consultation from a MFM specialist. Results Between 2001 and 2006, there were 108,703 pregnancies with delivery of 110,890 neonates. Forty five percent had one or more of the conditions identified for co-management/consultation. Overall pregnancies receiving MFM contact remained unchanged at 22.2% in 2001 and 22.1% in 2006. However, face to face contacts decreased from 14.6% (2001) to 8.7% (2006) while telemedicine consults increased from 7.6% (2001) to 13.3% (2006). Health departments were most likely and family practitioners least likely to refer to MFM (p< 0.001). Pregnancy complications leading to MFM referrals include cardiac complications, renal disease, systemic disorders, PPROM, suspected fetal abnormalities, and cervical insufficiency. Conclusion Referral of high risk pregnancies to MFMs varies with the level of expertise at the primary prenatal site. Increased contact between MFMs and local providers increased MFM referrals.
When the research project described in this paper began in 2001, promoting consumer involvement in health and social care research had become a major policy goal (DoH, 1999; DoH, 2000). Indeed, NHSE Trent, who funded the project, asked how I, as the researcher, planned to involve consumers in the research. I (Josie) was conscious that older people, the focus of the study, would traditionally have had research conducted 'on them' rather than 18
BACKGROUND: Incorporating didactics designed to improve teaching skills into departmental agenda is challenging but necessary. Often lectures take place once a year with little continuing reinforcement. Five Minute Teaching Time Outs (5MTTO) were created to introduce and reinforce important teaching skills to all levels of educators. The goal was to incorporate them into routine departmental activities such as M&M/Grand Rounds. METHODS: A multicenter prospective survey was conducted to assess faculty, fellow and resident attitudes towards the 5MTTO. Six-5MTTOs were created to cover a broad range of teaching topics. These were presented over the year at routinely scheduled department meetings. Participants were asked to fill out an anonymous survey at the completion of each 5MTTO. RESULTS: On average 45 participants were present at each 5MTTO among the 3 institutions, usually evenly split between faculty/fellows and residents. On average, after each session, participants agreed/strongly agreed that material from the individual 5MTTOs would influence their teaching approach 82–97% of the time. Over 92% of the time participants agreed/strongly agreed that 5 minutes was adequate and over 93% agreed/strongly agreed to having future 5MTTO. DISCUSSION: Incorporating teaching skills into departmental activities can be difficult due to time constraints. Regular reinforcement is as important for educators as it is for learners. These 5MTTO are well-received by the department, fit into already scheduled activities and may influence the teaching behaviors of our clinician-educators.
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