Recent Research Publications- July 2024

Living well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors.

Pennington KP, Schlumbrecht M, McGregor BA, Goodheart MJ, Heron L, Zimmerman B, Telles R, Zia S, Penedo FJ, Lutgendorf SK.

Contemp Clin Trials. 2024 Jun 22:107612. doi: 10.1016/j.cct.2024.107612. Epub ahead of print. PMID: 38914309.

Background: Ovarian cancer (OC) survivors commonly experience chronic symptoms including anxiety, depression, sleep disturbances, fatigue, physical symptoms, poor health-related quality of life (HRQOL), and a generally poor prognosis. Additionally, factors such as social isolation, stress, and depression are associated with key biological processes promoting tumor progression and poorer survival. Accessible psychosocial interventions to improve HRQOL and clinical outcomes are needed. This need is particularly true in rural settings where survivors may have less access to clinic-based support systems.

Methods: The Living Well Study, a cluster-randomized Phase II multi-site clinical trial, is designed to evaluate the efficacy of a group-based, web-delivered psychosocial intervention (Mindful Living) verses a Health Promotion active control (Healthy Lifestyles) in increasing HRQOL and decreasing perceived stress (primary outcomes), depressive mood, anxiety, and fatigue (secondary outcomes) for 256 OC survivors who are <5 years post-primary therapy. Mindful Living targets key concerns of OC survivors and teaches stress reduction skills and coping strategies utilizing cognitive behavioral, mindfulness, and acceptance and commitment therapies. Healthy Lifestyles provides lifestyle information including exercise, nutrition, sleep, and other survivorship topics. Interventions consist of 11 consecutive weekly group sessions lasting 1.5-2 h led by trained facilitators and two booster sessions. Participants complete psychosocial questionnaires at baseline, post-intervention, at 6-months, and at 12-months. A subset completes bloodspots for analysis of inflammatory biology.

Conclusion: Easily accessible psychosocial interventions addressing key concerns of OC survivors are an unmet need. The Mindful Living intervention has the potential to substantially enhance HRQOL and decrease distress in OC survivors. Trial registrationclinicaltrials.gov Identifier: NCT04533763.

For a full text of the article, click here: https://www.sciencedirect.com/science/article/pii/S1551714424001952?via%3Dihub

Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care.

Stanhope KK, Stallworth T, Forest AD, Vuncannon D, Juarez G, Boulet SL, Geary F, Dunlop AL, Blake SC, Green VL, Jamieson DJ.

Contemp Clin Trials. 2024 Jun 3;143:107586. doi: 10.1016/j.cct.2024.107586. Epub ahead of print. PMID: 38838985.

• Black and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI > 30)] to promote postpartum visit attendance.

Methods: To address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4-12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care).

• Through engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings.

Trial registration: This trial was registered on ClinicalTrials.gov (NCT05430815) on June 23, 2022.

For a full text of the article, click here: https://www.sciencedirect.com/science/article/pii/S1551714424001691?via%3Dihub

Return to Running for Postpartum Elite and Subelite Athletes.

Woodroffe L, Slayman T, Paulson A, Kruse N, Mancuso A, Hall M.

Sports Health. 2024 Jun 12:19417381241256973. doi: 10.1177/19417381241256973. Epub ahead of print. PMID: 38864285.

Context: There is little evidence to guide elite athletes who desire returning to competition after giving birth to a child. Ultimately, this can result in decreased performance and increased risk of injury. This paper addresses aspects that must be considered when building and monitoring a return to running program for a postpartum elite or subelite athlete, including pelvic floor and core stability, progressive reloading of the musculoskeletal system, monitoring of nutritional parameters, and considerations for lactation.

Evidence acquisition: PubMed and CINAHL (Cumulative Index for Nursing and Allied Health Literature) were searched with the following search strategy: (extreme sports OR elite athletes OR running OR exercise) AND (breastfeeding OR lactation OR bone density OR fetal weight OR gestational weight gain OR postpartum or post-partum OR postnatal OR post-natal OR pregnancy OR childbirth). The following information is based on best available evidence and clinical experience.

Study design: Clinical review.

Level of evidence: Level 4.

• Due to the interplay between cardiovascular fitness, postpartum nutrition, lactation, and progressive reloading of the muscular and skeletal system, we propose a multimodal, multidisciplinary approach to safely and successfully allow an athlete to return to an elite level of competition.

• Return to running in the postpartum period is a highly individualized process that benefits from multidisciplinary, individualized care. This includes monitoring of nutrition, core and pelvic floor function, bone reloading, muscle and tendon reloading, and breastfeeding care when applicable.

Strengh of recommendation taxonomy (sort): C.

For a full text of the article, click here: https://journals.sagepub.com/doi/10.1177/19417381241256973

The implications of using maternity care deserts to measure progress in access to obstetric care: a mixed-integer optimization analysis.

Meredith ME, Steimle LN, Radke SM.

BMC Health Serv Res. 2024 May 30;24(1):682. doi: 10.1186/s12913-024-11135-4. PMID: 38811929; PMCID: PMC11137923.

Background: Lack of access to risk-appropriate maternity services, particularly for rural residents, is thought to be a leading contributor to disparities in maternal morbidity and mortality. There are several existing measures of access to obstetric care in the literature and popular media. In this study, we explored how current measures of obstetric access inform the number and location of additional obstetric care facilities required to improve access.

• We formulated two facility location optimization models to determine the number of new facilities required to minimize the number of reproductive-aged women who lack access to obstetric care. We define regions with a lack of access as either maternity care deserts, designated by the March of Dimes to be counties with no obstetric care facility or obstetric providers, or regions further than 50 miles from critical care obstetric (CCO) services. We gathered information on hospitals with obstetric services from Georgia Department of Public Health public reports and estimated the female reproductive-age population by census block group using the American Community Survey.

• Out of the 1,910,308 reproductive-aged women who live in Georgia, 104,158 (5.5%) live in maternity care deserts, 150,563 (7.9%) reproductive-aged women live further than 50 miles from CCO services, and 38,202 (2.0%) live in both maternity care desert and further than 50 miles from CCO services. Our optimization analysis suggests that at least 56 new obstetric care facilities (a 67% increase) would be required to eliminate maternity care deserts in Georgia. However, the expansion of 8 facilities would ensure all women in Georgia live within 50 miles of CCO services.

• Current measures of access to obstetric care may not be sufficient for evaluating access and planning action toward improvements. In a state like Georgia with a large number of small counties, eliminating maternity care deserts would require a prohibitively large number of new obstetric care facilities. This work suggests that additional measures and tools are needed to estimate the number and type of obstetric care facilities that best match practical resources to meet obstetric care needs.

For a full text of the article, click here: https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11135-4

Machine Learning: a new era for cardiovascular pregnancy physiology and cardio-obstetrics research.

Ricci CA, Crysup B, Phillips NR, Ray WC, Santillan MK, Trask AJ, Woerner AE, Goulopoulou S.

Am J Physiol Heart Circ Physiol. 2024 Jun 7. doi: 10.1152/ajpheart.00149.2024. Epub ahead of print. PMID: 38847756.

The maternal cardiovascular system undergoes functional and structural adaptations during pregnancy and postpartum to support increased metabolic demands of offspring and placental growth, labor, and delivery, as well as recovery from childbirth. Pregnancy thus poses physiological stress upon the maternal cardiovascular system, and in the absence of an appropriate response it imparts potential risks for cardiovascular complications and adverse outcomes. The proportion of pregnancy-related maternal deaths from cardiovascular events has been steadily increasing, contributing to high rates of maternal mortality. Despite advances in cardiovascular physiology research, there is still no comprehensive understanding of maternal cardiovascular adaptations in healthy pregnancies, and with far less known about pregnancy with complications. Further, current tools for prognosis of cardiovascular complications during pregnancy are limited. Machine learning (ML) offers new and effective tools for investigating mechanisms involved in pregnancy-related cardiovascular complications as well as the development of potential therapies. The main goal of this review is to summarize existing research that uses ML to understand mechanisms of cardiovascular physiology during pregnancy and develop prediction models for clinical application in pregnant patients. We also provide an overview of ML fundamentals and a discussion about platforms that can be used to enhance understanding of cardiovascular adaptations to pregnancy. Finally, we address the interpretability and explainability of ML outcomes, consequences of model bias, and ethics of ML use.

For a full text of the article, click here: https://journals.physiology.org/doi/abs/10.1152/ajpheart.00149.2024

The Association of Female and Male Preconception Dyslipidemia with Live Birth in Couples Seeking Fertility Treatment.

Bollig KJ, Barnhart KT, Schisterman EF, Johnstone EB, Peterson CM, Hotaling JM, Ryan G, Van Voorhis BJ, Carrell DT, Mendola P, Mills JL, Harhay MO, Zee J, Mumford SL.

J Clin Endocrinol Metab. 2024 Jun 24:dgae427. doi: 10.1210/clinem/dgae427. Epub ahead of print. PMID: 38913692.

Context: Dyslipidemia is common, and resultant endothelial dysfunction may impact reproductive outcomes. No prospective study has examined the effect of preconception lipid parameters in both female and male partners or their interaction on live birth.

• To determine whether live birth is associated with preconception lipids in both partners by planned fertility treatment.

• Secondary analysis of the Folic Acid and Zinc Supplementation Trial, conducted between June 2013-December 2017. Couples were followed for nine months after randomization and until delivery.

Setting: Multicenter study.

• Couples seeking fertility treatment (n = 2370; females 18-45 years, males ≥18 years).

• Female, male, and couple abnormal versus normal preconception lipid concentrations (total cholesterol [TC], low-density lipoprotein [LDL], high-density lipoprotein [HDL], triglycerides [TG]).

Main outcome measures: Live birth.

• Among 2370 couples, most males (84%) and females (76%) had at least one abnormal lipid parameter. Males planning in vitro fertilization (IVF, n = 373) with elevated LDL had lower probability of live birth than those with normal levels (47.4% vs. 59.7%, aRR 0.79, 95% CI 0.65-0.98). In couples planning IVF where both partners had elevated TC or LDL, live birth was lower than those with normal levels (TC: 32.4% vs. 58.0%, aRR 0.53, 95% CI 0.36-0.79; and LDL: 41.9% vs. 63.8%, aRR 0.69, 95% CI 0.55-0.85). Lipid parameters were not associated with live birth for couples planning non-IVF treatments.

• Couples planning IVF where both partners had elevated TC or LDL and males planning IVF with elevated LDL had decreased probability of live birth. These findings may support lipid screening in patients seeking fertility treatment for prognostic information for reproductive outcomes.

For a full text of the article, click here: https://academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgae427/7697985

Postoperative venous thromboembolism risk in patients with vulvar carcinoma: An analysis of the National surgical Quality Improvement Program (NSQIP) database.

Kistenfeger Q, Felix AS, Meade CE, Wagner V, Bixel K, Chambers LM.

Gynecol Oncol Rep. 2024 May 12;54:101411. doi: 10.1016/j.gore.2024.101411. PMID: 38803657; PMCID: PMC11128827.

• Due to low incidence of vulvar cancer (VC), incidence and predictors for development of venous thromboembolism (VTE) are poorly understood. We examined incidence and risk factors associated with VTE in patients undergoing surgery for VC.

Methods: We included patients who underwent surgery for VC from the National Surgical Quality Improvement Program database. VTE within the 30-day postoperative period was captured with Current Procedural Terminology codes. Baseline demographics and clinical characteristics were compared between patients with and without VTE. Univariable and multivariable-adjusted exact logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between risk factors and VTE.

• We identified 1414 patients undergoing procedures for VC from the NSQIP database. Overall, 11 (0.8 %) patients developed VTE. Univariable predictors of VTE included surgery type [compared with simple vulvectomy: radical vulvectomy only (OR = 7.97, 95 % CI = 1.44, infinity) and radical vulvectomy plus unilateral IFN (OR = 15.98, 95 % CI = 2.70, infinity)], unplanned readmission (OR = 11.56, 95 % CI = 2.74, 46.38), deep surgical site infection (OR = 16.05, 95 % CI = 1.59-85.50), and preoperative thrombocytosis (OR = 6.53, 95 % CI = 0.00, 34.86). In a multivariable-adjusted model, longer operative time (≥72 min OR = 11.33, 95 % CI = 1.58-499.03) and preoperative functional status [compared with complete independence: total dependence (OR = 53.88, 95 % CI = 0.85, infinity) and partial dependence (OR = 53.88, 95 % CI = 0.85, infinity)] were associated with VTE.

• In this cohort of patients with VC undergoing radical vulvectomy, VTE incidence was low. Surgery type, longer operative time, dependent functional status, and wound disruption were identified as risk factors. Our findings highlight opportunities for prophylactic intervention in certain patients.

For a full text of the article, click here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11128827/