Background Our objective was to determine whether preconception-initiated low dose aspirin (LDA) improved live birth rates in women with one to two prior pregnancy losses. Methods This multi-center, block-randomized, double-blind, placebo-controlled trial recruited from four medical centers in the US (2006–2012). Women aged 18–40 years attempting pregnancy were stratified by eligibility criteria: “original”: women with one loss <20 weeks’ gestation during the past year; or “expanded”: women with one to two prior losses regardless of gestational length or time of loss. Women were block-randomized (615 LDA, 613 placebo) by center and eligibility stratum. Preconception-initiated daily LDA (81 mg/day) was compared with placebo for up to six menstrual cycles; for those who conceived, study treatment continued until 36 weeks’ gestation. The primary outcome was live birth rate. The trial was registered on ClinicalTrials.gov (#NCT00467363). Findings Overall, 1078 women completed the trial (LDA 535, placebo 543). Live birth rates were 58% (309/535) in women assigned LDA vs. 53% placebo (286/543; risk difference [RD] 5%; 95% confidence interval [CI] −0·8, 11). Pregnancy loss rates were similar between groups (13% [68/535] LDA, 12% [65/543] placebo; p=0·7812). In the original stratum, live birth rates were 62% (151/242) LDA vs. 53% (133/250) placebo (RD 9%; 95% CI 0·5, 18), and in the expanded, 54% (158/293) LDA vs. 52% (153/293) placebo (RD 2%; 95% CI −6, 10). Major adverse events were similar between treatment arms. LDA was associated with increased bleeding per vaginam, but this was not associated with losses. Interpretation Preconception-initiated LDA was not significantly associated with live birth or pregnancy loss among women with one to two prior losses. However, higher live birth rates were observed among women with a single documented loss at <20 weeks’ gestation during the previous year. LDA is not recommended for the prevention of pregnancy loss.
Background Low dose aspirin (LDA) has been proposed to improve pregnancy outcomes in couples experiencing recurrent pregnancy loss. However, results from studies of LDA on pregnancy outcomes have been inconsistent, perhaps because most studies evaluated LDA-initiated post-conception. The purpose of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was to determine whether preconception-initiated LDA improves live-birth rates in women with 1–2 prior losses. Methods We performed a multicenter, block randomised, double-blind, placebo-controlled trial. Study participants were recruited using community-based advertisements and physician referral to four university medical centers in the US (2006–12). Eligible women were aged 18–40 years actively trying to conceive with 1–2 prior losses. Participants were randomised to receive daily LDA (81 mg/day) or a matching placebo, and all were provided with daily 400 mcg folic acid. Follow-up continued for ≤six menstrual cycles while attempting to conceive. For those that conceived, treatment was continued until 36 weeks gestation. The primary outcome was the cumulative live birth rate over the trial period. Results 1228 women were randomised (615 LDA, 613 placebo). Participants had a mean age of 28.7, were mostly white (95%), well educated (86% >high school education), and employed (75%) with a household income >$100,000 annually (40%). Characteristics of those in the treatment and placebo arms were well-balanced. Conclusions We describe the study design, recruitment, data collection, and baseline characteristics of participants enrolled in EAGeR, which aimed to determine the effect of LDA on live birth and other pregnancy outcomes in these women.
Founded in 1970 to train physicians to practice in community health centers and underserved areas, the Residency Program in Social Medicine (RPSM) of Montefiore Medical Center, Bronx, New York, has graduated 562 board-eligible family physicians, general internists, and pediatricians whose careers fulfill this mission. The RPSM was a model for federal funding for primary care residency programs and has received Title VII grants during most of its history. The RPSM has tailored its mission and structured its curriculum to promote a community and population orientation and to provide the requisite knowledge and skills for integrating social medicine into clinical practice. Six unique hallmarks of RPSM training are (1) mission-oriented resident recruitment/selection and self-management, (2) interdisciplinary collaborative training among primary care professionals, (3) community-health-center-based and community-oriented primary care education, (4) biopsychosocial and ecological family systems curriculum, (5) the social medicine core curriculum and projects, and (6) grant support through Title VII. These hallmark curricular, training, and funding elements, in which population health is deeply embedded, have been carefully evaluated, regularly revised, and empirically validated since the program's inception. Practice outcomes for RPSM graduates as leaders in and advocates for population health and the care of underserved communities are described and discussed in this case study.
Background: Clinician educators face barriers to scholarship including lack of time, insufficient skills, and access to mentoring. An urban department of family medicine implemented a federally funded Scholars Program to increase the participants’ perceived confidence, knowledge and skills to conduct educational research.Method: A part-time faculty development model provided modest protected time for one year to busy clinician educators. Scholars focused on designing, implementing, and writing about a scholarly project. Scholars participated in skill seminars, cohort and individual meetings, an educational poster fair and an annual writing retreat with consultation from a visiting professor. We assessed the increases in the quantity and quality of peer reviewed education scholarship. Data included pre- and post-program self-assessed research skills and confidence and semi-structured interviews. Further, data were collected longitudinally through a survey conducted three years after program participation to assess continued involvement in educational scholarship, academic presentations and publications.Results: Ten scholars completed the program. Scholars reported that protected time, coaching by a coordinator, peer mentoring, engagement of project leaders, and involvement of a visiting professor increased confidence and ability to apply research skills. Participation resulted in academic presentations and publications and new educational leadership positions for several of the participants.Conclusions: A faculty scholars program emphasizing multi-level mentoring and focused protected time can result in increased confidence, skills and scholarly outcomes at modest cost.
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