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Published associations between combined oral contraceptive use and uterine fibroid development have lacked prospective imaging with ultrasound to distinguish between incident and prevalent fibroids. The Study of Environment, Lifestyle, and Fibroids prospectively followed fibroid-free, African-American women (the group with the highest disease burden in the U.S.) to identify incident cases. We examined associations between combined oral contraceptive use and the 40-month cumulative risk of fibroids. History of hormonal contraceptive use was collected via telephone interview at enrollment. Fibroid identification was performed using transvaginal ultrasonography at enrollment, and at 20 and 40-months of follow-up. Inverse probability weights for exposures and censoring were used to construct weighted risk ratios (wRR) and weighted risk different (wRD) estimators which control for differences in fibroid risk factors between exposure groups. In addition, unweighted fully adjusted log-binomial regression models (aRR) were run for comparison. Of the 1,308 participants in the analysis sample, 70% had used combined oral contraceptives and 17% developed fibroids by 40 months. We observed an inverse association between ever use of combined oral contraceptives and cumulative fibroid incidence (wRR: 0.78; 95% Confidence Interval (CI): 0.60, 1.00; wRD: -0.05, 95% CI: -0.11, 0; aRR: 0.76, 95% CI: 0.60, 0.98). Fibroid incidence was greater in participants who started using combined oral contraceptives after age 17 years than among younger initiators, though the restriction to ever-users made this estimate less precise (wRR: 1.25; 95% CI: 0.89, 1.76; wRD: 0.04, 95% CI: -0.02, 0.10). No consistent patterns of fibroid incidence were seen among ever-users for duration of, or years since, last combined oral contraceptives use.

Over recent decades, numerous medical procedures have migrated out of hospitals and into freestanding ambulatory surgery centers (ASCs) and physician offices, with possible implications for patient outcomes. In response, states have passed regulations for office-based surgeries, private organizations have established standards for facility accreditation, and professional associations have developed clinical guidelines. While abortions have been performed in office setting for decades, states have also enacted laws requiring that facilities that perform abortions meet specific requirements. The extent to which facility requirements have an impact on patient outcomes-for any procedure-is unclear. We conducted a systematic review to examine the effect of outpatient facility type (ASC vs. office) and specific facility characteristics (e.g., facility accreditation, emergency response protocols, clinician qualifications, physical plant characteristics, other policies) on patient safety, patient experience and service availability in non-hospital-affiliated outpatient settings. To identify relevant research, we searched databases of the published academic literature (PubMed, EMBASE, Web of Science) and websites of governmental and non-governmental organizations. Two investigators reviewed 3049 abstracts and full-text articles against inclusion/exclusion criteria and assessed the quality of 22 identified articles. Most studies were hampered by methodological challenges, with 12 of 22 not meeting minimum quality criteria. Of 10 studies included in the review, most (6) examined the effect of facility type on patient safety. Existing research appears to indicate no difference in patient safety for outpatient procedures performed in ASCs vs. physician offices. Research about specific facility characteristics is insufficient to draw conclusions. More and higher quality research is needed to determine if there is a public health problem to be addressed through facility regulation and, if so, which facility characteristics may result in consistent improvements to patient safety while not adversely affecting patient experience or service availability.

The field of reproductive epidemiology has primarily focused on reproductive outcomes and gynaecologic cancers. The study of non-cancerous, gynaecologic conditions (eg, uterine fibroids, endometriosis) has not received serious treatment in existing epidemiology textbooks and reproductive epidemiology curricula. Further, these conditions do not neatly fit into the other common subdisciplines within epidemiology (eg, infectious disease, cardiovascular, injury and occupational epidemiology and so on). In this commentary, we identify and illustrate three critical challenges to advancing the epidemiologic research of non-cancerous, gynaecologic conditions. With greater investment and a patient-centred approach, epidemiology can advance knowledge about this critical area of human welfare.

Background & aims In the United States, Non-Hispanic Black (Black) people are 2–threefold more likely than Non-Hispanic White (White) people to have pregnancy complications, such as a baby with low birthweight. Multi-level, community-based interventions aimed at mitigating the impacts of interpersonal and structural racism may decrease bias, improve the quality of care, and improve pregnancy outcomes. The Accountability for Cancer Care through Undoing Racism and Equity and the Heart Health Now studies reduced disparities in cancer treatment and cardiovascular risk, respectively. The Accountability for Care through Undoing Racism and Equity for Moms Study (ACURE4Moms) was modified from these successful interventions and designed to test the impact of multi-level, community-engaged antiracism interventions delivered on disparities in low birth weight (LBW) (Aim 1), experiences with perinatal depression and experiences with discrimination in medical settings (Aim 2) and other patient-centered outcomes. We will also measure implementation barriers and facilitators (Aim 3). Methods ACURE4Moms is a 4-arm, cluster-randomized trial which has enrolled 39 prenatal practices randomized to implement the following interventions for 2 years: Arm 1–Standard Care; Arm 2—Data Accountability and Transparency; Arm 3—Community-Based Doula linkages; and Arm 4—Data and Doula interventions combined. Practice staff in Arms 2–4 will also receive quarterly Maternal Healthcare Equity Education and Training. A subgroup of 100 Black patients from each practice will participate in a longitudinal survey that measures mental health symptoms and experiences with discrimination during pregnancy and postpartum. A stakeholder advisory board including doulas, community members, and policymakers helps to make decisions regarding study design, implementation, and dissemination. Multi-level mixed models will be used to evaluate outcomes using administrative, vital records and survey data. The primary outcome is a reduction in low birth weight for Black infants. Secondary outcomes include reductions in hospitalizations and emergency department use, mental health symptoms, and experiences with discrimination during pregnancy and postpartum. Intermediate outcomes include implementation barriers and facilitators. Discussion The findings of the ACURE4Moms study will inform policy makers, health systems, clinicians and communities about the effectiveness of multi-level, practice-based interventions to reduce maternal health disparities and provide information regarding scalability. Trial Registration This trial has been prospectively registered as (7/29/2022) with clinicaltrials.gov under the name Accountability for Care Through Undoing Racism & Equity for Moms (ACURE4Moms), Identifier: NCT05484804. URL: https://clinicaltrials.gov/ct2/show/NCT05484804 .

Objective To assess the impact of a web-based decision aid on patient-centered decision making outcomes among women considering a trial of labor after cesarean (TOLAC) versus planned repeat cesarean delivery. Methods The Birth Decision Aid Study (B-READY) was a quasi-experimental pre-post study of two sequential cohorts. From June 18, 2018 to July 31, 2019, 50 women were enrolled in routine care, followed by 50 women who were enrolled in the decision aid group. Inclusion criteria were singleton pregnancies between 19/0 to 36/6 weeks, ≤2 prior cesareans, and no contraindications to TOLAC. The decision aid group viewed the online Healthwise® “Pregnancy: Birth Options After Cesarean” program. Both groups received the same birth options counseling and completed the same online assessment. Primary patient-centered outcomes were knowledge about birth options and shared decision making at online assessment, and informed, patient-centered decision making about her preferred mode of delivery at delivery admission. Results Among 100 women participated in this study (50 per group), the mean gestational age at enrollment was 31 weeks, and 71% or 63/89 women who consented to delivery data abstraction had a cesarean delivery. Women in the patient decision aid group gained more knowledge (defined as score ≥ 75%) about birth options compared to those in the routine care group (72% vs. 32%; adjusted odds ratio, AOR: 6.15 [95% CI: 2.34 to 16.14]), and were more likely to make an informed, patient-centered decision (60% vs. 26%; AOR: 3.30 [95% CI: 1.20 to 9.04]. Women in both groups reported similar involvement in shared decision making, as well as satisfaction and values. More than 90% of decision aid users reported it was a useful tool and would recommend it to other TOLAC-eligible women. Conclusions A web-based birth options patient-centered decision aid for TOLAC eligible women can be integrated into prenatal Telehealth and may improve the quality of decision making about mode of delivery. Trial registration The study was registered with ClinincalTrials.gov and the ID# was NCT04053413 . Registered 12 August 2019 – Retrospectively registered.

Our objective was to test the hypothesis that intrauterine exposure to gestational diabetes [GDM] predicts childhood growth independent of the effect on infant birthweight. We conducted a prospective analysis of 28,358 mother-infant pairs who enrolled in the National Collaborative Perinatal Project between 1959 and 1965. The offspring were followed until age 7. Four hundred and eighty-four mothers (1.7%) had GDM. The mean birthweight was 3.2 kg (range 1.1–5.6 kg). Maternal characteristics (age, education, race, family income, pre-pregnancy body mass index and pregnancy weight gain) and measures of childhood growth (birthweight, weight at ages 4, and 7) differed significantly by GDM status (all P  < 0.05). As expected, compared to their non-diabetic counterparts, mothers with GDM gave birth to offspring that had higher weights at birth. The offspring of mothers with GDM were larger at age 7 as indicated by greater weight, BMI and BMI z-score compared to the offspring of mothers without GDM at that age (all P  < 0.05). These differences at age 7 persisted even after adjustment for infant birthweight. Furthermore, the offspring of mothers with GDM had a 61% higher odds of being overweight at age 7 compared to the offspring of mothers without GDM after adjustment for maternal BMI, pregnancy weight gain, family income, race and birthweight [OR = 1.61 (95%CI:1.07, 1.28)]. Our results indicate that maternal GDM status is associated with offspring overweight status during childhood. This relationship is only partially mediated by effects on birthweight.

Background Cardiovascular disease (CVD) guidelines recommend using the Pooled Cohort Equation (PCE) to assess 10-year CVD risk based on traditional risk factors. Pregnancy-related factors have been associated with future CVD. We examined the contribution of two pregnancy-related factors, (1) history of a low birthweight (LBW) infant and (2) breastfeeding to CVD risk accounting for traditional risk factors as assessed by the PCE. Methods A nationally representative sample of women, ages 40–79, with a history of pregnancy, but no prior CVD, was identified using NHANES 1999–2006. Outcomes included (1) CVD death and (2) CVD death plus CVD surrogates. We used Cox proportional hazards models to adjust for PCE risk score. Results Among 3,758 women, 479 had a LBW infant and 1,926 reported breastfeeding. Mean follow-up time was 12.1 years. Survival models showed a consistent reduction in CVD outcomes among women with a history of breastfeeding. In cause-specific survival models, breastfeeding was associated with a 24% reduction in risk of CVD deaths (HR 0.76; 95% CI 0.45─1.27, p  = 0.30) and a 33% reduction in risk of CVD deaths + surrogate CVD, though not statistically significant. (HR 0.77; 95% CI 0.52─1.14, p  = 0.19). Survival models yielded inconclusive results for LBW with wide confidence intervals (CVD death: HR 0.98; 95% CI 0.47─2.05; p  = 0.96 and CVD death + surrogate CVD: HR 1.29; 95% CI 0.74─2.25; p  = 0.38). Conclusion Pregnancy-related factors may provide important, relevant information about CVD risk beyond traditional risk factors. While further research with more robust datasets is needed, it may be helpful for clinicians to counsel women about the potential impact of pregnancy-related factors, particularly the positive impact of breastfeeding, on cardiovascular health.

Background Post-partum weight retention contributes to the risk of chronic obesity and metabolic alterations. We conducted a systematic review of randomized controlled trials (RCTs) on the effect of post-partum nutrition and exercise interventions on weight loss and metabolic outcomes. DATA SOURCES: Four electronic databases were searched from inception to January, 2012. Two investigators reviewed titles and abstracts, performed data abstraction on full articles and assessed study quality. Methods We included RCTs comparing nutrition, exercise or combined nutrition and exercise interventions with a control condition. Thirteen studies met our inclusion criteria (N = 1,310 participants). Data were abstracted on study characteristics, intervention components, enrollment period, and length of follow-up. Outcomes of interest included weight, adiposity, cardio-metabolic measures (glucose, lipids) and obesity-related inflammatory markers. Results Nine trials compared combined interventions to standard post-partum care; three trials assessed the effect of exercise interventions, one trial evaluated a nutrition-only intervention. Four good quality RCTs on combined interventions had inconsistent findings, with the larger RCT (N = 450) reporting no difference in weight between groups. Four fair-to good quality RCTs reported greater weight loss in the combined intervention group vs. standard care, ranging from 0.17 kg to 4.9 kg. Results from exercise only interventions were inconclusive. Evidence for nutrition only interventions was insufficient. There was insufficient evidence for the effect of post-partum interventions on metabolic risk factors and inflammatory biomarkers. Conclusions Combined nutrition and exercise interventions can achieve weight loss, but evidence is limited due to a small number of trials and limitations in study design.

Limited evidence suggests that hyperinsulinemia may contribute to the risk of breast, endometrial, and, possibly, ovarian cancer. The aim of this study was to assess the association of serum glucose and insulin with risk of these cancers in postmenopausal women, while taking into account potential confounding and modifying factors. We studied 21 103 women with fasting baseline insulin and glucose measurements in a subsample of the Women’s Health Initiative. The subsample was composed of four studies within Women’s Health Initiative with different selection and sampling strategies. Over a mean of 14.7 years of follow-up, 1185 breast cancer cases, 156 endometrial cancer cases, and 130 ovarian cancer cases were diagnosed. We used Cox proportional hazards models to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) by quartile of glucose or insulin. Serum insulin was positively associated with breast cancer risk (multivariable-adjusted HR for highest vs. lowest quartile 1.41, 95% CI: 1.16–1.72, P trend <0.0003), and glucose and insulin were associated with roughly a doubling of endometrial cancer risk (for glucose: HR: 2.00, 95% CI: 1.203.35, P trend =0.01; for insulin: HR: 2.39, 95% CI: 1.32–4.33, P trend =0.008). These associations remained unchanged or were slightly attenuated after mutual adjustment, adjustment for serum lipids, and assessment of possible reverse causation. Glucose and insulin showed no association with ovarian cancer. Our findings provide support for a role of insulin-related pathways in the etiology of cancers of the breast and endometrium. However, because of the unrepresentative nature of the sample, our results need confirmation in other populations.

PurposeAfrican-American (AA) female cancer survivors share a disproportionate burden of diabetes compared to their white counterparts. Our objectives were to explore the perspectives of AA survivors with type 2 diabetes on perceived barriers to physical activity (PA) and preferences for a PA intervention and develop a framework for a PA program after cancer treatment.MethodsTrained interviewers conducted semi-structured interviews with AA survivors of breast or endometrial cancer with diabetes (total n = 20; 16 breast, 4 endometrial). Thirteen open-ended questions were posed to stimulate discussions, which were audio recorded and transcribed verbatim. Two investigators independently reviewed transcriptions and extracted coded quotations to identify major themes.ResultsMedian age of participants was 63 years. Nine themes were identified that focused on post-treatment physical symptoms (e.g., lymphedema, bone/joint pain, depression symptoms and self-motivation as barriers to PA, exercise routines tailored to physical limitations and peer partners and program leaders who understand their emotional health needs). The S.U.C.C.E.S.S. framework summarizes the survivors’ preferences for an effective lifestyle intervention: Support efforts to maintain PA, Understand physical and depression symptoms, Collaborate with multi-disciplinary provider, Coordinate in-person intervention activities, Encourage partnerships among survivors for comorbidity risk reduction, develop Sustainable coping strategies for side effects of treatment, and Share local community resources.ConclusionsSurvivors verbalized the need for a multi-disciplinary team to assist with their psychosocial needs and physical limitations to achieve their PA goals, as integrated into the S.U.C.C.E.S.S. framework.Implications for cancer survivorsThe S.U.C.C.E.S.S. framework reflects the perspectives of survivors with type 2 diabetes and may help to inform post-treatment programs.