IMPORTANCE Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring. OBJECTIVE To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood. DESIGN, SETTING, AND PARTICIPANTS The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued. INTERVENTIONS Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D. MAIN OUTCOMES AND MEASURES Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels. RESULTS Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001). CONCLUSIONS AND RELEVANCE In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important.
Quebec Breast Cancer Foundation and Genome Canada Innovation Network. This trial was funded by the National Heart, Lung, and Blood Institute. For details see Acknowledgments.
COMMITTEE STATEMENT: At the 69th annual meeting of the American Society of Plastic Surgeons (ASPS) in October of 2000, the ASPS Board of Directors convened the Task Force on Patient Safety in Office-Based Surgery Facilities. The task force was assembled in the wake of several highly publicized patient deaths involving plastic surgery and increasing state legislative and regulatory activity of office-based surgery facilities. In response to the increased scrutiny of the office-based surgery setting, the task force produced two practice advisories: "Procedures in the Office-Based Surgery Setting" and "Patient Selection in the Office-Based Surgery Setting." Since the task force's inception, professional and public awareness of patient safety issues has continued to grow. This heightened interest resulted in an increased need for plastic surgeons to communicate their views on the topic. To meet this challenge, the task force evolved into the Committee on Patient Safety, allowing the committee to address topics affecting the safety and welfare of plastic surgery patients, regardless of the facility setting. The "Practice Advisory on Liposuction" is the first advisory developed since the committee was formed. It was a lengthy and painstaking process for the committee, which included representatives from related plastic surgery organizations as well as the American Society of Anesthesiologists (ASA). Committee members included Ronald E. Iverson, M.D., chair; Jeffery L. Apfelbaum, M.D., ASA representative; Bruce L. Cunningham, M.D., ASPS/Plastic Surgery Educational Foundation (PSEF) Joint Outcomes Task Force representative; Richard A. D'Amico, M.D., ASPS representative; Victor L. Lewis, Jr., M.D., ASPS Health Policy Analysis Committee representative; Dennis J. Lynch, M.D., ASPS representative; Noel B. McDevitt, M.D., ASPS Deep Vein Thrombosis Task Force representative; Michael F. McGuire, M.D., The American Society for Aesthetic Plastic Surgery (ASAPS) representative; Louis Morales, Jr., M.D., American Society of Maxillofacial Surgeons representative; Calvin R. Peters, M.D., Florida Ad Hoc Commission on Patient Safety representative; Robert Singer, M.D., American Association for Accreditation of Ambulatory Surgery Facilities representative; Thomas Ray Stevenson, M.D., American College of Surgeons representative; Rebecca S. Twersky, M.D., ASA representative; Ronald H. Wender, M.D., ASA representative; and James A. Yates, ASAPS representative. The authors thank members of the committee for the insights they brought to this process. The final document represents their significant contributions to these efforts. They would also like to recognize DeLaine Schmitz and Pat Farrell of the ASPS staff for their work on and support of this project.
ObjectivesGestational diabetes mellitus (GDM) greatly increases the risk of developing diabetes in the decade after delivery, but few women receive appropriately timed postpartum glucose testing (PPGT) or a referral to primary care (PC) for continued monitoring. This qualitative study was designed to identify barriers and facilitators to testing and referral from patient and providers' perspectives.MethodsWe interviewed patients and clinicians in depth about knowledge, values, priorities, challenges, and recommendations for increasing PPGT rates and PC linkage. Interviews were coded with NVIVO data analysis software, and analyzed using an implementation science framework.ResultsWomen reported motivation to address GDM for the health of the fetus. Most women did not anticipate future diabetes for themselves, and focused on delivery outcomes rather than future health risks. Patients sought and received reassurance from clinicians, and were unlikely to discuss early onset following GDM or preventive measures. PPGT barriers described by patients included provider not mentioning the test or setting it up, transportation difficulties, work responsibilities, fatigue, concerns about fasting while breastfeeding, and timing of the test after discharge from obstetrics, and no referral to PC for follow-up. Practitioners described limited communication among multiple care providers during pregnancy and delivery, systems issues, and separation of obstetrics from PC.ConclusionsPatients' barriers to PPGT included low motivation for self-care, structural obstacles, and competing priorities. Providers reported the need to balance risk with reassurance, and identified systems failures related to test timing, limitations of electronic medical record systems (EMR), lack of referrals to PC, and inadequate communication between specialties. Prevention of early onset has great potential for medical cost savings and improvements in quality of life.
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