Special Section on Patient-Reported Outcomes and Informatics: Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 31 embedded pragmatic clinical trials, and many of these trials use patient-reported outcome measures (PROMs) to provide valuable information about their patients' health and wellness. Often these trials enroll medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, or rural or frontier communities. In this series of trial case reports, we provide lessons learned about collecting PROMs in these populations.

Barriers and Facilitators to Integrating Acupuncture into the U.S. Health Care System: A Scoping Review.

Acupuncture is a widely practiced complementary and integrative health modality that has multiple clinical applications. The use of acupuncture in the United States is rapidly increasing. Although studies have shown the efficacy and effectiveness of acupuncture for various ailments, the integration of acupuncture into the U.

Sexual and Gender Minority Patients' First Pelvic Examination Experiences: What Clinicians Need to Know.

Study Objective: The aim of this study was to identify factors that influence the first pelvic exam experiences of sexual and gender minority (SGM) adolescents and young adults who were assigned female at birth (AFAB).

Methods: Using purposive sampling, we recruited SGM AFAB individuals, ages 18-24, who had had at least 1 pelvic examination. Semi-structured interviews and an iterative approach allowed for the emergence of factors influencing the first pelvic exam experience.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Qualitative research design.

Consent for Examinations Under Anesthesia With Learners at the Time of Abortion: Physician Perspectives.

Introduction: Although obtaining specific consent for examinations under anesthesia with learners is recommended by major professional organizations and mandated by many state laws and institutions, it is not practiced universally. We sought to investigate physicians' experiences using a formalized process to obtain consent from patients presenting for surgical abortions under anesthesia for pelvic examinations with learners.

Methods: Semistructured qualitative interviews were conducted with residents, fellows, and faculty who work or have rotated in a single family planning clinic after the clinic introduced this consent process.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems.

Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care.

Recruitment and Retention of Urban Pregnant Women to a Clinical Study Administering an Oral Isotope Dietary Tracer.

Introduction: Pregnant women are a vulnerable population that are difficult to engage in clinical research. We report successful recruitment and retention strategies used in a longitudinal pilot study of urban racially/ethnically diverse pregnant women that involved administration of an orally ingested isotope tracer, multiple venipunctures, biopsy of placenta after delivery, and cord or placental blood collection.

Materials And Methods: We used direct strategies to recruit English-speaking obese and nonobese pregnant women aged 17-45 years, who were in the third trimester of pregnancy.

Patient Perceptions Impact Progression to Third-Line Therapy for Treatment of Overactive Bladder.

Purpose: We aimed to understand the reasons patients choose to pursue third-line overactive bladder (OAB) therapy.

Materials And Methods: We conducted a mixed methods study that included patient interviews and survey data. Eligible patients were diagnosed by symptoms, had tried behavioral modifications, and OAB medications enrolled from October 2018 to August 2019.

Prepregnancy Obesity Does Not Impact Placental Iron Trafficking.

Background: Iron is critical for fetal development. Neonates of obese women may be at risk for poor iron status at birth as a result of maternal inflammation-driven overexpression of hepcidin.

Objectives: The objective of this study was to determine differences in placental transfer of oral iron (57Fe) and expression of placental transferrin receptor 1 (TFR1) and ferroportin (FPN) mRNA and protein and their association with maternal and neonatal iron-related parameters, including maternal hepcidin, among women with and without prepregnancy (PP) obesity.

Womb to womb: Maternal litter size and birth weight but not adult characteristics predict early neonatal death of offspring in the common marmoset monkey.

A singular focus on maternal health at the time of a pregnancy leaves much about perinatal mortality unexplained, especially when there is growing evidence for maternal early life effects. Further, lumping stillbirth and early neonatal death into a single category of perinatal mortality may obscure different causes and thus different avenues of screening and prevention. The common marmoset monkey (Callithrix jacchus), a litter-bearing nonhuman primate, is an ideal species in which to study the independent effects of a mother's early life and adult phenotypes on pregnancy outcomes.

Long-Term Postpartum Cardiac Function and Its Association With Preeclampsia.

Background Preeclampsia is a prominent risk factor for long-term development of cardiovascular disease. Although existing studies report a strong correlation between preeclampsia and heart failure, the underlying mechanisms are poorly understood. One possibility is the glycoprotein growth factor activin A.

Antepartum Aspirin Administration Reduces Activin A and Cardiac Global Longitudinal Strain in Preeclamptic Women.

Background Approximately 60% of women have Stage B heart failure 1 year after a preeclamptic delivery. Emerging evidence suggests that the profibrotic growth factor activin A, which has been shown to induce cardiac fibrosis and hypertrophy, is elevated in preeclampsia and may be inhibited by aspirin therapy. We hypothesized that preeclamptic women receiving aspirin would have lower activin A levels and reduced global longitudinal strain (GLS), a sensitive measure of cardiac dysfunction, than women who do not receive aspirin.

Prepregnancy Obesity Is Not Associated with Iron Utilization during the Third Trimester.

Background: An adequate maternal iron supply is crucial for maternal red blood cell (RBC) expansion, placental and fetal growth, and fetal brain development. Obese women may be at risk for poor iron status in pregnancy due to proinflammatory-driven overexpression of hepcidin leading to decreased iron bioavailability.

Objective: The objective of this study was to determine the impact of prepregnancy (PP) obesity on third-trimester maternal iron utilization.

The common marmoset monkey: avenues for exploring the prenatal, placental, and postnatal mechanisms in developmental programming of pediatric obesity.

Animal models have been critical in building evidence that the prenatal experience and intrauterine environment are capable of exerting profound and permanent effects on metabolic health through developmental programming of obesity. However, despite physiological and evolutionary similarities, nonhuman primate models are relatively rare. The common marmoset monkey ( Callithrix jacchus) is a New World monkey that has been used as a biomedical model for well more than 50 years and has recently been framed as an appropriate model for exploring early-life impacts on later health and disease.

Experiences Accessing Abortion Care in Alabama among Women Traveling for Services.

Background: In Alabama, more than one-half of reproductive-aged women live in counties without an abortion provider. State regulations require in-person counseling (or confirmed receipt of materials sent by certified mail) followed by a 48-hour waiting period. We explored the impact of this service and policy environment on experiences accessing abortion care for women traveling long distances to clinics.

Developmental origins of pregnancy loss in the adult female common marmoset monkey (Callithrix jacchus).

Background: The impact of the intrauterine environment on the developmental programming of adult female reproductive success is still poorly understood and potentially underestimated. Litter size variation in a nonhuman primate, the common marmoset monkey (Callithrix jacchus), allows us to model the effects of varying intrauterine environments (e.g.

Comparison of fresh to fixed weights of the vervet monkey (Chlorocebus sabaeus) placenta and its relation to gestational age.

Background: Focus on the placenta as an agent of fetal development and offspring health outcomes is growing. Primate research facilities or zoos may collect and fix placental tissue for long-term storage, but little is known about the effects of formalin fixation on the non-human primate placenta.

Methods:   We obtained 48 vervet monkey placentas from the St.