Faculty Bibliography

OBJECTIVE:Assess postintervention and dose effects of a child obesity prevention program, delivered from pregnancy through the age of 3 years, on child weight outcomes at the ages of 4 and 5 years among low-income Hispanic families. METHODS:As postintervention follow-up of the Starting Early Program (StEP) randomized controlled trial, StEP enrolled pregnant people in the third trimester to standard care control or the StEP intervention, which provided 15 nutrition and parenting support sessions. We analyzed differences in weight-for-age z scores (WFAz) and obesity status by group within intervention group analyses of program dose and moderation by adverse social drivers of health (SDoH). RESULTS:Weight data were available for 312 and 264 children aged 4 and 5 years, respectively. Mean WFAz (0.59 [1.08] vs 0.52 [1.16], P = .55; 0.60 [1.07] vs 0.58 [1.22], P = .86) and proportion with obesity (15.2% vs 15.6%, P = .90; 16.2% vs 19.5%, P = .47) were not different by intervention status at the ages of 4 and 5 years. The mean (SD) number of sessions attended was 8.7 (4.2) with the highest tertile attending 11 sessions or more. Lower WFAz and obesity prevalence were found for families with top tertile attendance. In moderation analysis, impacts on weight in children aged 5 years were greater for families with low social support compared high social support. CONCLUSION/CONCLUSIONS:Participation in StEP was not associated with postintervention differences in child weight. Higher attendance was associated with lower obesity prevalence, while treatment effects were greater for families with low social support. This highlights the need to evaluate program dose on long-term outcomes, especially for those with adverse SDoH.

IMPORTANCE/UNASSIGNED:Evidence regarding suppressive valacyclovir treatment on postherpetic neuralgia is necessary to guide care. OBJECTIVE/UNASSIGNED:To test the hypothesis that suppressive treatment with 1000 mg/d of oral valacyclovir for 12 months reduces the prevalence, severity, and duration of postherpetic neuralgia compared with placebo at 12 and 18 months in participants with herpes zoster ophthalmicus (HZO). DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Multicenter, placebo-controlled randomized clinical trial including 527 immunocompetent, nonpregnant adults with history of HZO rash, documented keratitis, or iritis within 1 year and an estimated glomerular filtration rate of 45 mL/min/1.73 m2 or greater. The study was conducted at 95 participating sites (in Canada, New Zealand, and the US) from November 2017 to June 2024 and participant visits occurred every 3 months. INTERVENTION/UNASSIGNED:Treatment with 1000 mg/d of valacyclovir or placebo for 12 months. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Prevalence of postherpetic neuralgia, severity as determined by pain score (a score of ≥3 on a scale of 1-10), pain duration (≥3 months after HZO onset), and total daily dose of pain medication. RESULTS/UNASSIGNED:Of the 527 participants (490 completed 12 months of treatment and 460 completed 18 months), 73 (14%) had postherpetic neuralgia and were analyzed by age at HZO onset (<60 years or ≥60 years) and disease duration (recent [<6 months] or chronic [≥6 months]). Of the 73 participants with postherpetic neuralgia (34 in the valacyclovir group and 39 in the placebo group), the mean age was 62.4 years (SD, 13.6 years), 59% were female, 5% were Black or African American, and 10% were Hispanic. The prevalence of postherpetic neuralgia at 12 months was not reduced by valacyclovir (12/32 [38%]) compared with placebo (14/35 [40%]) (between-group difference, 2.5% [95% CI, -20.8% to 25.8%]; P>.99). The participants who were younger than 60 years at HZO onset and had a chronic disease duration had lower pain scores in the valacyclovir group (mean score, 0.3 [SD, 0.9]) vs the placebo group (mean score, 0.8 [SD, 1.9]) at 12 months (P = .045) and at 18 months (mean score, 0.2 [SD, 0.9] vs 1.0 [SD, 2.3], respectively; P = .02). There was a decrease in pain duration in the valacyclovir group at 18 months (mean, 13.6 [SD, 11.4] months) vs the placebo group (mean, 18.7 [SD, 29.5] months) (linear mixed-effects model between-group difference, -3.39 months [95% CI, -6.73 to -0.04 months]; P = .046). The total daily dose of neuropathic pain medication was lower in the valacyclovir group (mean, 271.4 [SD, 593.8] mg/d) vs the placebo group (mean, 363.4 [SD, 592.2] mg/d) at 12 months (linear mixed-effects model P = .006) and at 18 months (mean, 209.0 [SD, 412.8] mg/d vs 286.2 [SD, 577.9] mg/d, respectively; linear mixed-effects model P = .01). CONCLUSIONS AND RELEVANCE/UNASSIGNED:One year of suppressive treatment with valacyclovir was associated with a lower dosage of neuropathic pain medication. Participants in the valacyclovir group, who were younger at HZO onset and had a chronic disease duration, had lower pain scores. These secondary outcomes support consideration of 1 year of suppressive treatment with valacyclovir to reduce dosage of pain medications and pain due to HZO. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03134196.

BACKGROUND/UNASSIGNED:Chronic kidney disease (CKD) impacts more than 800 million people. It causes significant suffering and disproportionately impacts marginalized populations in the United States. Kidney palliative care has the potential to alleviate this distress, but has not been tested. This pilot study evaluates the feasibility of a randomized clinical trial (RCT) testing the efficacy of integrated kidney palliative and CKD care in an urban safety-net hospital. METHODS/UNASSIGNED:, and are receiving care at our safety net hospital. Participants will be randomized in permuted blocks of two or four to either the intervention group, who will receive monthly ambulatory care visits for six months with a palliative care provider trained in kidney palliative care, or to usual nephrology care. Primary outcomes are feasibility of recruitment, retention, fidelity to the study visit protocol, and the ability to collect outcome data. These outcomes include symptom burden, quality of life, and engagement in advance care planning. DISCUSSION/UNASSIGNED:This pilot RCT will provide essential data on the feasibility of testing integrated palliative care in CKD care in an underserved setting. These outcomes will inform a larger, fully powered trial that tests the efficacy of our kidney palliative care approach. CLINICAL TRIAL REGISTRATION/UNASSIGNED:NCT04998110.

BACKGROUND:Prostate cancer (PCa) diagnosis and treatment can have a significant negative impact on sexual health, affecting patients and their partners; however, the impact on partners is insufficiently addressed in current practice. OBJECTIVE:We describe the development and validation of an instrument to measure sexual health in female partners of patients with PCa. DESIGN, SETTING, AND PARTICIPANTS/METHODS:Questions assessing sexual health were developed through a literature review, two qualitative studies, and an expert consensus process. Candidate survey items were tested through cognitive interviews and used to iteratively refine the questionnaire. INTERVENTION/METHODS:The final questionnaire was tested in a validation study among 200 female partners. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS/METHODS:We performed an exploratory factor analysis, followed by an analysis for internal validity, test-retest reliability, and convergent and discriminant validity. RESULTS AND LIMITATIONS/CONCLUSIONS:An initial set of 32 items was developed and refined through cognitive interviews. The resulting 27-item questionnaire was tested among 200 female partners of patients with PCa from across the USA. The exploratory factor analysis eliminated eight items and revealed seven key factors: (1) distress/satisfaction, (2) loss of connection as a couple, (3) active communication, (4) discomfort with communication, (5) frustration with sexual counseling, (6) expansion of sexual repertoire, and (7) nonpenetrative sexual activity. The overall scale demonstrated strong internal consistency (ordinal alpha 0.94) and test-retest reliability (0.89). Strengths of the study include development and evaluation of the first questionnaire to evaluate sexual quality of life among female partners of patients with PCa. However, additional work is needed to assess sexual health and quality of life among male and nonbinary partners. CONCLUSIONS:We developed a new instrument, the Sexual Concerns In Partners of Patients with Prostate cancer (SCIPPP-F), and found it to be valid in a diverse sample of female partners across the USA. PATIENT SUMMARY/RESULTS:Our new instrument can be used to characterize sexual health among female partners of patients with prostate cancer.

Policies to implement climate-forcing pollution emission reductions have often been stymied by economic and political divisiveness. However, certain uncontested nonregret public health policies that also carry climate-forcing cobenefits with them could provide more achievable policy pathways to accelerate the implementation of climate mitigation. An International Society for Environmental Epidemiology Policy Committee endorsed pre-28th Conference of the Parties climate meeting workshop brought together experts on environment, diet, civic planning, and health to review current understanding of public health policy approaches that provide climate change mitigation cobenefits by also reducing greenhouse gas emissions. Promising public health policy areas identified as also providing climate mitigation cobenefits included: improving air quality through stronger regulation of harmful combustion-related air pollutants, advancing healthier plant-based public food procurement programs, promoting more sustainable transport options, developing healthier infrastructure (e.g., combustion-free buildings), and reducing the use of climate forcing substances in healthcare. It is concluded that cities, states, and nations, when aided by involved health professionals, can advance many practical public health, diet, and civic planning policies to improve health and well-being that will also serve to translate climate mitigation ambitions into action.

CONTEXT/BACKGROUND:Chronic kidney disease (CKD) disproportionately impacts lower socioeconomic groups and is associated with many symptoms and complex decisions. Integration of Kidney Supportive Care (KSC) with CKD care can address these needs. To our knowledge, this approach has not been described in an underserved population. OBJECTIVES/OBJECTIVE:We describe our adaptation of an ambulatory integrated KSC and CKD clinic for implementation in a safety net hospital. We report our utilization metrics; characteristics of the population served; and visit activities. METHODS:We considered modifications from the perspectives of people with CKD, their providers, and the health system. Modifications were informed by meeting notes with key participants (hospital administrators [n = 5], funders [n = 1], and content experts [n = 2]), as well as literature on palliative care program building, safety net hospitals, and KSC. We extracted utilization data for the first 15 months of the clinic's operations, demographics, clinical characteristics, unmet health related social needs, and symptom burden, measured by the Integrated Palliative Outcome Scale-Renal (total Score, and sub-scores of physical, psychological, and practical impact of CKD) from the electronic health record. Results are reported using descriptive statistics. RESULTS:Adaptions were proactive and done by clinical and administrative leaders. Meetings identified challenges of the safety net setting including people presenting with advanced disease and having several social needs. Modifications to our base model were made in staffing, data collection, and work flow. Show rate was approximately 68%, with a majority of people identifying as Black or Hispanic, and uninsured or on Medicaid. Symptom burden was lower than previous reports, driven by a better psychological sub-score. CONCLUSIONS:We describe a feasible ambulatory care model of KSC in a safety net setting that can serve as a framework for the development of other noncancer palliative care ambulatory clinics. Future work will optimize our model.

INTRODUCTION/BACKGROUND:Varicose veins are common in older adults and are associated with adverse clinical outcomes such as deep venous thrombosis. Established risk factors for varicose veins include female sex, height, and obesity, but other risk factors are relatively uncharacterized. METHODS:This was a prospective cohort analysis of 6241 participants aged 66-70 years from the Atherosclerosis Risk in Communities (ARIC) Study. Incident varicose veins were defined as two outpatient encounters (at least a week apart) or inpatient diagnoses through 2018 with ICD 9 code 454 or ICD 10 code I83. Participants with a history of clinically-recognized varicose veins at baseline were excluded. Cox regression was used to evaluate established (e.g., female, height, body mass index) and potential demographic and clinical risk factors. RESULTS:During a median follow-up of 13 years, 349 (6%) of participants developed clinically-recognized varicose veins. Consistent with prior research, female sex, taller height, and higher body mass index were associated with varicose veins. After accounting for these, White race, prevalent heart failure, loop diuretic use, higher cardiac troponin T, and higher natriuretic peptide were independently associated with incident varicose veins. CONCLUSIONS:In this community-based cohort study of older adults, known and newly identified risk factors, including cardiac function and heart failure, were independently associated with incidence of clinically-recognized varicose veins. The potential usefulness of cardiac biomarkers for prevention and screening of varicose veins requires further investigations.

BACKGROUND/UNASSIGNED:Studies have reported higher lung cancer incidence among groups with lower socioeconomic position (SEP). However, it is not known how this difference in lung cancer incidence between SEP groups varies across different geographical settings. Furthermore, most prior studies that assessed the association between SEP and lung cancer incidence were conducted without detailed adjustment for smoking. Therefore, we aimed to assess this relationship across world regions. METHODS/UNASSIGNED:In this international prospective cohort consortium study, we used data from the Lung Cancer Cohort Consortium (LC3), which includes 20 prospective population cohorts from 16 countries in North America, Europe, Asia, and Australia. Participants were enrolled between 1985 and 2010 and followed for cancer outcomes using registry linkages and/or active follow-up. We estimated hazard ratios (HRs) for the association between educational level (our primary measure of SEP, in 4 categories) and incident lung cancer using Cox proportional hazards models separately for participants with and without a smoking history. The models were adjusted for age, sex, cohort (when multiple cohorts were included), smoking duration, cigarettes per day, and time since cessation. FINDINGS/UNASSIGNED: = 0.75, 95% CI = 0.62-0.90). INTERPRETATION/UNASSIGNED:Based on longitudinal data from 2.5 million participants from 16 countries, our findings suggest that higher educational attainment was associated with lower lung cancer risk among participants with a smoking history, but not among participants who never smoked. Limitations of our study include that cohort participants cannot fully represent the general populations of the geographical regions included, and education was the only measure of SEP consistently available across our consortium. FUNDING/UNASSIGNED:This study was supported in part by the National Cancer Institute (NCI), the Lung Cancer Research Foundation (LCRF), and the World Cancer Research Fund (WCRF).