The race-based stress reduction intervention (RiSE) study on African American women in NYC and Chicago: Design and methods for complex genomic analysis.

RiSE study aims to evaluate a race-based stress-reduction intervention as an effective strategy to improve coping and decrease stress-related symptoms, inflammatory burden, and modify DNA methylation of stress response-related genes in older AA women. This article will describe genomic analytic methods to be utilized in this longitudinal, randomized clinical trial of older adult AA women in Chicago and NYC that examines the effect of the RiSE intervention on DNAm pre- and post-intervention, and its overall influence on inflammatory burden. Salivary DNAm will be measured at baseline and 6 months following the intervention, using the Oragene-DNA kit. Measures of perceived stress, depressive symptoms, fatigue, sleep, inflammatory burden, and coping strategies will be assessed at 4 time points including at baseline, 4 weeks, 8 weeks, and 6 months. Genomic data analysis will include the use of pre-processed and quality-controlled methylation data expressed as beta (ß) values. Association analyses will be performed to detect differentially methylated sites on the targeted candidate genes between the intervention and non-intervention groups using the Δß (changes in methylation) with adjustment for age, health behaviors, early life adversity, hybridization batch, and top principal components of the probes as covariates. To account for multiple testing, we will use FDR adjustment with a corrected p-value of <0.05 regarded as statistically significant. To assess the relationship between inflammatory burden and Δß among the study samples, we will repeat association analyses with the inclusion of individual inflammation protein measures. ANCOVA will be used because it is more statistically powerful to detect differences.

An objective assessment of the impact of tendon retraction on sleep efficiency in patients with full-thickness rotator cuff tears: a prospective cohort study.

BACKGROUND: Sleep quality, quantity, and efficiency have all been demonstrated to be adversely affected by rotator cuff pathology. Previous measures of assessing the impact of rotator cuff pathology on sleep have been largely subjective in nature. This study was undertaken to objectively analyze this relationship through the use of activity monitors. METHODS: Patients with full-thickness rotator cuff tears at a single institution were prospectively enrolled between 2018 and 2020. Waistworn accelerometers were provided for the patients to use each night for 14 days. Sleep efficiency was calculated using the ratio of the time spent sleeping to the total amount of time that was spent in bed. Retraction of the rotator cuff tear was classified using the Patte staging system. RESULTS: This study included 36 patients: 18 with Patte stage 1 disease, 14 with Patte stage 2 disease, and 4 patients with Patte stage 3 disease. During the study, 25 participants wore the monitor on multiple nights, and ultimately their data was used for the analysis. No difference in the median sleep efficiency was appreciated amongst these groups (P>0.1), with each cohort of patients demonstrating a generally high sleep efficiency. CONCLUSIONS: The severity of retraction of the rotator cuff tear did not appear to correlate with changes in sleep efficiency for patients (P>0.1). These findings can better inform providers on how to counsel their patients who present with complaints of poor sleep in the setting of full-thickness rotator cuff tears. Level of evidence: Level II.

Reducing Disparities in Postpartum Care Utilization: Development of a Clinical Risk Assessment Tool.

INTRODUCTION: Patients receiving care at Federally Qualified Health Centers (FQHCs) have low postpartum care attendance. Perinatal morbidity and mortality disproportionately affect patients with low-income and are potentially preventable. The purpose of this study was to develop a clinical decision support tool to identify FQHC patients less likely to return for postpartum care. To accomplish this purpose, we evaluated established predictors and novel risk factors in our patient population. METHODS: This is a retrospective, secondary data analysis of 50,022 patients who received prenatal care past 24 weeks' gestation in FQHCs between 2012 and 2017. The postpartum visit was defined using Healthcare Effectiveness Data and Information Set measures as early care (birth to 21 days) and later care (21-84 days). Anderson's Behavioral Model for Access to Healthcare guided inclusion of potentially predictive factors. We stratified data by postpartum care attendance, and a final predictive model was selected by model fit statistics and clinical relevance. RESULTS: In our sample, 64% of birthing persons attended postpartum care at FQHCs. Of those who returned for care, 38% returned within 21 days postbirth and 62% returned between 21 and 84 days, with 28% returning for both early and later care. Predictors for postpartum care attendance included maternal age, parity, gestational age at first visit, and number of prenatal care visits. A clinical decision support tool for identifying patients less likely to return for care was created. DISCUSSION: An easy to implement clinical decision support tool can help identify FQHC patients at risk for postpartum nonattendance. Future interventions to improve adequacy of prenatal care can encourage early entry into prenatal care and sufficient prenatal visits. These efforts may improve postpartum care attendance and maternal health.

Assessment of Interpretation Modality and Patient Comprehension in Spanish-speaking Limited English Proficiency (LEP) Patients Presenting to the Emergency Department.

BACKGROUND: Provider-patient language discrepancies with limited English proficiency (LEP) patients can lead to misunderstandings about diagnoses and follow-up care. OBJECTIVES: To assess interpretation modalities used in the emergency department (ED) in terms of patient satisfaction and understanding of discharge diagnosis. METHODS: Spanish-speaking LEP patients completed a survey assessing overall satisfaction and discharge diagnosis comprehension. Modalities included in-person (interpreter or physician/nurse), remote (phone or video), or combination. Differences in proportions with correctly identified diagnoses were compared by modality using Fisher's exact test. RESULTS: Patients preferred a Spanish-speaking staff member (52%) or in-person interpreter (33%) over other modalities. Almost 74% of surveyed patients accurately described their discharge diagnosis. Diagnostic accuracy was increased among patients using remote modalities alone compared with in-person alone or combination (p=.02). CONCLUSION: Taking into account patient preferences and diagnostic accuracy, this study suggests the utility of having different interpreter modalities available for Spanish-speaking LEP ED patients.

Childhood Daily Energy Expenditure Does Not Decrease with Market Integration and Is Not Related to Adiposity in Amazonia.

BACKGROUND: Childhood overweight and obesity (OW/OB) is increasingly centered in low- and middle-income countries (LMICs) as rural populations experience market integration and lifeway change. Most explanatory studies have relied on imprecise estimates of children's energy expenditure, restricting understanding of the relative effects of changes in diet and energy expenditure on the development of OW/OB in transitioning contexts. OBJECTIVES: This study used gold-standard measurements of children's energy expenditure to investigate the changes that underlie OW/OB and the nutrition/epidemiologic transition. METHODS: Cross-sectional data were collected from "rural" (n = 43) Shuar forager-horticulturalist children and their "peri-urban" (n = 34) Shuar counterparts (age 4-12 y) in Amazonian Ecuador. Doubly labeled water measurements of total energy expenditure (TEE; kcal/d), respirometry measurements of resting energy expenditure (REE; kcal/d), and measures of diet, physical activity, immune activity, and market integration were analyzed primarily using regression models. RESULTS: Peri-urban children had higher body fat percentage (+8.1%, P < 0.001), greater consumption of market-acquired foods (multiple P < 0.001), lower concentrations of immune activity biomarkers (multiple P < 0.05), and lower REE (-108 kcal/d, P = 0.002) than rural children. Despite these differences, peri-urban children's TEE was indistinguishable from that of rural children (P = 0.499). Moreover, although sample-wide IgG concentrations and household incomes predicted REE (both P < 0.05), no examined household, immune activity, or physical activity measures were related to children's overall TEE (all P > 0.09). Diet and energy expenditure associations with adiposity demonstrate that only reported consumption of market-acquired "protein" and "carbohydrate" foods predicted children's body fat levels (multiple P < 0.05). CONCLUSIONS: Despite underlying patterns in REE, Shuar children's TEE is not reliably related to market integration and-unlike dietary measures-does not predict adiposity. These findings suggest a leading role of changing dietary intake in transitions to OW/OB in LMICs.

Insurance Acceptance, Appointment Wait Time, and Dermatologist Access Across Practice Types in the US.

Importance: In the 15 years since dermatology access was last investigated on a national scale, the practice landscape has changed with the rise of private equity (PE) investment and increased use of nonphysician clinicians (NPCs). Objective: To determine appointment success and wait times for patients with various insurance types at clinics with and without PE ownership. Design, Setting, and Participants: In this study, PE-owned US clinics were randomly selected and matched with 2 geographically proximate clinics without PE ownership. Researchers called each clinic 3 times over a 5-day period to assess appointment/clinician availability for a fictitious patient with a new and changing mole. The 3 calls differed by insurance type specified, which were Blue Cross Blue Shield (BCBS) preferred provider organization, Medicare, or Medicaid. Main Outcomes and Measures: Appointment success and wait times among insurance types and between PE-owned clinics and control clinics. Secondary outcomes were the provision of accurate referrals to other clinics when appointments were denied and clinician and next-day appointment availability. Results: A total of 1833 calls were made to 204 PE-owned and 407 control clinics without PE ownership across 28 states. Overall appointment success rates for BCBS, Medicare, and Medicaid were 96%, 94%, and 17%, respectively. Acceptance of BCBS (98.5%; 95% CI, 96%-99%; P = .03) and Medicare (97.5%; 95% CI, 94%-99%; P = .02) were slightly higher at PE-owned clinics (compared with 94.6% [95% CI, 92%-96%] and 92.8% [95% CI, 90%-95%], respectively, at control clinics). Wait times (median days, interquartile range [IQR]) were similar for patients with BCBS (7 days; IQR, 2-22 days) and Medicare (7 days; IQR, 2-25 days; P > .99), whereas Medicaid patients waited significantly longer (13 days; IQR, 4-33 days; P = .002). Clinic ownership did not significantly affect wait times. Private equity-owned clinics were more likely than controls to offer a new patient appointment with an NPC (80% vs 63%; P = .001) and to not have an opening with a dermatologist (16% vs 6%; P < .001). Next-day appointment availability was greater at PE-owned clinics than controls (30% vs 21%; P = .001). Conclusions and Relevance: Patients with Medicaid had significantly lower success in obtaining appointments and significantly longer wait times regardless of clinic ownership. Although the use of dermatologists and NPCs was similar regardless of clinic ownership, PE-owned clinics were more likely than controls to offer new patient appointments with NPCs.

Clinical characteristics and outcomes of patients with severe left ventricular dysfunction undergoing cardiac MRI viability assessment prior to revascularization.

Coronary artery bypass grafting improves survival in patients with ischemic cardiomyopathy, however, these patients are at high risk for morbidity and mortality. The role of viability testing to guide revascularization in these patients is unclear. Cardiac magnetic resonance imaging (CMR) has not been studied adequately in this population despite being considered a reference standard for infarct imaging. We performed a multicenter retrospective analysis of patients (n = 154) with severe left ventricular systolic dysfunction [ejection fraction (EF) < 35%] on CMR who underwent CMR viability assessment prior to consideration for revascularization. Using the AHA16-segment model, percent total myocardial viability was determined depending on the degree of transmural scar thickness. Patients with or without revascularization had similar clinical characteristics and were prescribed similar medical therapy. Overall, 43% of patients (n = 66) experienced an adverse event during the median 3 years follow up. For the composite outcome (death, myocardial infarction, heart failure hospitalization, stroke, ventricular tachycardia) patients receiving revascularization were less likely to experience an adverse event compared to those without revascularization (HR 0.53, 95% CI 0.33-0.86, p = 0.01). Patients with > 50% viability on CMR had a 47% reduction in composite events when undergoing revascularization opposed to medical therapy alone (HR 0.53, p = 0.02) whereas patients with a viability < 50% were 2.7 times more likely to experience an adverse event (p = 0.01). CMR viability assessment may be an important tool in the shared decision-making process when considering revascularization options in patients with severe ischemic cardiomyopathy.

Bias Assessment and Correction in Machine Learning Algorithms: A Use-Case in a Natural Language Processing Algorithm to Identify Hospitalized Patients with Unhealthy Alcohol Use.

Unhealthy alcohol use represents a major economic burden and cause of morbidity and mortality in the United States. Implementation of interventions for unhealthy alcohol use depends on the availability and accuracy of screening tools. Our group previously applied methods in natural language processing and machine learning to build a classifier for unhealthy alcohol use. In this study, we sought to evaluate and address bias through the use-case of our classifier. We demonstrated the presence of biased unhealthy alcohol use risk underestimation among Hispanic compared to Non-Hispanic White trauma inpatients, 18- to 44-year-old compared to 45 years and older medical/surgical inpatients, and Non-Hispanic Black compared to Non-Hispanic White medical/surgical inpatients. We further showed that intercept, slope, and concurrent intercept and slope recalibration resulted in minimal or no improvements in bias-indicating metrics within these subgroups. Our results exemplify the importance of integrating bias assessment early into the classifier development pipeline.

Brigham Eyebrow Tool for Alopecia: A Reliable Assessment of Eyebrow Alopecia Areata.

There are no tools to evaluate eyebrow involvement in patients with alopecia areata. We developed and assessed the reliability of the Brigham Eyebrow Tool for Alopecia (BETA) as a quantitative evaluation of eyebrow alopecia areata. BETA uses facial landmarks of eyebrow anatomy and is calculated using surface area and density. A total of 50 eyebrow images with varying levels of hair loss were distributed to six board-certified dermatologists at three academic medical centers with standardized instructions and examples. Interrater and intrarater reliability were calculated using intraclass correlation coefficients (ICCs). BETA demonstrated high interrater (ICC = 0.88, confidence interval = 0.83-0.92 right eyebrow scores and ICC = 0.90, confidence interval = 0.85-0.94 left eyebrow scores) and intrarater (ICC = 0.90, confidence interval = 0.85-0.93 right eyebrow scores and ICC = 0.91, confidence interval = 0.87-0.94 left eyebrow scores) reliability. When measured in the same patient with varying degrees of hair loss over time, BETA demonstrated sensitivity to change. BETA is a simple and reliable objective assessment of eyebrow alopecia areata. BETA is easy-to-use and quick to calculate, making it feasible for a variety of clinical and research settings. Although developed for alopecia areata, we hope that BETA will be investigated in other etiologies of eyebrow alopecia to serve as a universal tool for monitoring disease progression, improvement, and response to treatment.

Effect of Insurance Status on Clinical Outcomes After Shoulder Arthroplasty.

Shoulder arthroplasty is an effective treatment option for patients with symptomatic shoulder arthritis and rotator cuff arthropathy. Although there have been reports of variations in complication rates according to insurance type, few studies have examined the effect of payer status on functional outcomes. Patients who underwent elective shoulder arthroplasty performed by a single fellowship-trained surgeon and had a minimum of 1 year of follow-up were queried. Patient characteristics were compared across insurance types. Each patient completed the American Shoulder and Elbow Surgeons (ASES) questionnaire preoperatively and postoperatively. A generalized linear mixed model was specified to predict ASES score at 1 year and included preoperative ASES score as an adjustment variable. A total of 84 patients underwent 91 procedures. Before surgery, ASES score differed by insurance type (P=.014), with lower scores in the Medicaid cohort compared with the private insurance cohort (20.4 vs 38.8, P=.009). After controlling for baseline ASES score, postoperative ASES score at 1-year follow-up differed by insurance type (P<.001). Patients with private insurance had better ASES scores (85.6) than patients with Medicaid (55.2) (P<.001) and workers' compensation (57.1) (P=.028). Patients with Medicare (80.6) had better ASES scores at follow-up compared with those with Medicaid (P<.001). Patients with Medicaid are at risk for significantly lower postoperative functional outcome scores after shoulder arthroplasty compared with patients with private insurance and Medicare. In this study, patients with Medicaid had lower preoperative ASES scores compared with other groups. These observed differences are likely multifactorial and should be acknowledged when counseling patients. [Orthopedics. 2020;43(6):e523-e528.].

Patient Risk Assessment for Transcatheter Aortic Valve Replacement at Veterans Health Administration Hospitals.

OBJECTIVE: To compare patient-level risk assessment at Veterans Affairs (VA) hospitals in patients undergoing transcatheter aortic valve replacement (TAVR) with patients included in the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry. METHODS: We retrospectively analyzed the outcomes of veterans with severe aortic stenosis (AS) receiving TAVR from 2012-2016 at eight VA hospitals and compared them with TVT registry outcomes from 2012-2015. Patients were identified via administrative data. Univariable and multivariable Cox proportional hazards models were used to examine 30-day and 1-year all-cause mortality, 30-day and 1-year transient ischemic attack/stroke rates, and permanent pacemaker (PPM) implantation rates. RESULTS: During the study period, a total of 726 veterans underwent TAVR including valve-in-valve procedures (n = 50). Patients were predominantly male (98.2%), with mean age of 78.5 ± 9.3 years; 49.1% were at prohibitive risk and 12.1% were at high risk for surgical aortic valve replacement; 30-day and 1-year all-cause mortality rates were 2.5% and 14.7%, respectively; 30-day and 1-year combined TIA/stroke rates were 6.5% and 13.5%, respectively. In the TVT registry, 15.8% and 37.8% of patients were at prohibitive and high risk, respectively; 30-day and 1-year mortality rates were 5.7% and 22.7%, respectively, and stroke rates were 2.1% and 4.0%, respectively. CONCLUSIONS: This report on TAVR risk assessment within the VA system demonstrates that despite a large proportion of patients classified as prohibitive risk, TAVR was associated with favorable 30-day and 1-year all-cause mortality rates when compared with published outcomes from the STS/ACC TVT registry.

Trends, Cost, and Mortality From Sepsis After Trauma in the United States: An Evaluation of the National Inpatient Sample of Hospitalizations, 2012-2016.

OBJECTIVES: Identification and outcomes in patients with sepsis have improved over the years, but little data are available in patients with trauma who develop sepsis. We aimed to examine the cost and epidemiology of sepsis in patients hospitalized after trauma. DESIGN: Retrospective cohort study. PATIENTS: National Inpatient Sample. INTERVENTIONS: Sepsis was identified between 2012 and 2016 using implicit and explicit International Classification of Diseases, Ninth and Tenth Revision codes. Analyses were stratified by injury severity score greater than or equal to 15. Annual trends were modeled using generalized linear models. Survey-adjusted logistic regression was used to compare the odds for in-hospital mortality, and the average marginal effects were calculated to compare the cost of hospitalization with and without sepsis. MEASUREMENTS AND MAIN RESULTS: There were 320,450 (SE = 3,642) traumatic injury discharges from U.S. hospitals with sepsis between 2012 and 2016, representing 6.0% (95% CI, 5.9-6.0%) of the total trauma population (n = 5,329,714; SE = 47,447). In-hospital mortality associated with sepsis after trauma did not change over the study period (p > 0.40). In adjusted analysis, severe (injury severity score ≥ 15) and nonsevere injured septic patients had an odds ratio of 1.39 (95% CI, 1.31-1.47) and 4.32 (95% CI, 4.06-4.59) for in-hospital mortality, respectively. The adjusted marginal cost for sepsis compared with nonsepsis was $16,646 (95% CI, $16,294-$16,997), and it was greater than the marginal cost for severe injury compared with nonsevere injury $8,851 (95% CI, $8,366-$8,796). CONCLUSIONS: While national trends for sepsis mortality have improved over the years, our analysis of National Inpatient Sample did not support this trend in the trauma population. The odds risk for death after sepsis and the cost of care remained high regardless of severity of injury. More rigor is needed in tracking sepsis after trauma and evaluating the effectiveness of hospital mandates and policies to improve sepsis care in patients after trauma.

Association of Hospital Discharge Against Medical Advice With Readmission and In-Hospital Mortality.

Importance: Hospital readmissions contribute to higher expenditures and may sometimes reflect suboptimal patient care. Individuals discharged against medical advice (AMA) are a vulnerable patient population and may have higher risk for readmission. Objectives: To determine odds of readmission and mortality for patients discharged AMA vs all others, to characterize patient and hospital-level factors associated with readmissions, and to quantify their overall cost burden. Design, Setting, and Participants: Nationally representative, all-payer cohort study using the 2014 National Readmissions Database. Eligible index admissions were nonobstetrical/newborn hospitalizations for patients 18 years and older discharged between January 2014 and November 2014. Admissions were excluded if there was a missing primary diagnosis, discharge disposition, length of stay, or if the patient died during that hospitalization. Data were analyzed between January 2018 and June 2018. Exposures: Discharge AMA and non-AMA discharge. Main Outcomes and Measures: Thirty-day all-cause readmission and in-hospital mortality rate. Results: There were 19.9 million weighted index admissions, of which 1.5% resulted in an AMA discharge. Within the AMA cohort, 85% were younger than 65 years, 63% were male, 55% had Medicaid or other (including uninsured) coverage, and 39% were in the lowest income quartile. Thirty-day all-cause readmission was 21.0% vs 11.9% for AMA vs non-AMA discharge (P < .001), and 30-day in-hospital mortality was 2.5% vs 5.6% (P < .001), respectively. Individuals discharged AMA were more likely to be readmitted to a different hospital compared with non-AMA patients (43.0% vs 23.9%; P < .001). Of all 30-day readmissions, 19.0% occurred within the first day after AMA discharge vs 6.1% for non-AMA patients (P < .001). On multivariable regression, AMA discharge was associated with a 2.01 (95% CI, 1.97-2.05) increased adjusted odds of readmission and a 0.80 (95% CI, 0.74-0.87) decreased adjusted odds of in-hospital mortality compared with non-AMA discharge. Nationwide readmissions after AMA discharge accounted for more than 400 000 inpatient hospitalization days at a total cost of $822 million in 2014. Conclusions and Relevance: Individuals discharged AMA have higher odds of 30-day readmission at significant cost to the health care system and lower in-hospital mortality rates compared with non-AMA patients. Patients discharged AMA are also more likely to be readmitted to different hospitals and to have earlier bounce-back readmissions, which may reflect dissatisfaction with their initial episode of care.

Patient Outcomes and Cost-Effectiveness of a Sepsis Care Quality Improvement Program in a Health System.

OBJECTIVES: Assess patient outcomes in patients with suspected infection and the cost-effectiveness of implementing a quality improvement program. DESIGN, SETTING, AND PARTICIPANTS: We conducted an observational single-center study of 13,877 adults with suspected infection between March 1, 2014, and July 31, 2017. The 18-month period before and after the effective date for mandated reporting of the sepsis bundle was examined. The Sequential Organ Failure Assessment score and culture and antibiotic orders were used to identify patients meeting Sepsis-3 criteria from the electronic health record. INTERVENTIONS: The following interventions were performed as follows: 1) multidisciplinary sepsis committee with sepsis coordinator and data abstractor; 2) education campaign; 3) electronic health record tools; and 4) a Modified Early Warning System. MAIN OUTCOMES AND MEASURES: Primary health outcomes were in-hospital death and length of stay. The incremental cost-effectiveness ratio was calculated and the empirical 95% CI for the incremental cost-effectiveness ratio was estimated from 5,000 bootstrap samples. RESULTS: In multivariable analysis, the odds ratio for in-hospital death in the post- versus pre-implementation periods was 0.70 (95% CI, 0.57-0.86) in those with suspected infection, and the hazard ratio for time to discharge was 1.25 (95% CI, 1.20-1.29). Similarly, a decrease in the odds for in-hospital death and an increase in the speed to discharge was observed for the subset that met Sepsis-3 criteria. The program was cost saving in patients with suspected infection (-$272,645.7; 95% CI, -$757,970.3 to -$79,667.7). Cost savings were also observed in the Sepsis-3 group. CONCLUSIONS AND RELEVANCE: Our health system's program designed to adhere to the sepsis bundle metrics led to decreased mortality and length of stay in a cost-effective manner in a much larger catchment than just the cohort meeting the Centers for Medicare and Medicaid Services measures. Our single-center model of interventions may serve as a practice-based benchmark for hospitalized patients with suspected infection.

The ALT-70 cellulitis model maintains predictive value at 24 and 48 hours after presentation.

BACKGROUND: Cellulitis has many potential mimickers, and its misdiagnosis often leads to unnecessary hospitalizations and higher health care costs. The ALT-70 predictive model offers an objective tool to help differentiate between cellulitis and other clinically similar conditions at the time of initial emergency department (ED) presentation. OBJECTIVE: To evaluate the performance of the ALT-70 predictive model at 24 and 48 hours following ED presentation. METHODS: We performed a retrospective review of our prior cohort and expanded our data collection to include data at 24 and 48 hours after initial ED presentation. We compared classification measures for the ALT-70 at the time of initial ED presentation, 24 hours after presentation, and 48 hours after presentation. RESULTS: There was a statistically significant difference in median ALT-70 score between patients with true cellulitis and those with mimickers of cellulitis at all time points. Sensitivity, specificity, positive predictive value, and negative predictive value of the ALT-70 score was similar across all 3 time points. LIMITATIONS: Single-center design may reduce generalizability. CONCLUSION: At 24 and 48 hours, the ALT-70 performed similarly to the way it performed at the time of initial ED presentation, allowing for its use in a wider array of clinical settings.

Constraint and trade-offs regulate energy expenditure during childhood.

Children's metabolic energy expenditure is central to evolutionary and epidemiological frameworks for understanding variation in human phenotype and health. Nonetheless, the impact of a physically active lifestyle and heavy burden of infectious disease on child metabolism remains unclear. Using energetic, activity, and biomarker measures, we show that Shuar forager-horticulturalist children of Amazonian Ecuador are ~25% more physically active and, in association with immune activity, have ~20% greater resting energy expenditure than children from industrial populations. Despite these differences, Shuar children's total daily energy expenditure, measured using doubly labeled water, is indistinguishable from industrialized counterparts. Trade-offs in energy allocation between competing physiological tasks, within a constrained energy budget, appear to shape childhood phenotypic variation (e.g., patterns of growth). These trade-offs may contribute to the lifetime obesity and metabolic health disparities that emerge during rapid economic development.

Modeling specialty medicine access: Understanding key health system processes and players.

OBJECTIVES: To map the specialty medicine process from prescription writing to the patient obtaining medication, identify perceived barriers to access, and highlight potential opportunities for improved efficiency as understood from the perspective of 3 key stakeholder groups: specialty disease clinicians, staff members, and specialty pharmacists. DESIGN: Qualitative research study using semi-structured individual interviews. SETTING AND PARTICIPANTS: Interviews were conducted at a single large tertiary care center targeting clinicians and staff in the hepatitis C, oncology, cystic fibrosis, multiple sclerosis, and rheumatoid arthritis clinics. The second set of participants was pharmacists and technicians at specialty community pharmacies within one large retail chain that was not directly affiliated with the health system. RESULTS: Four conceptual models of specialty medicine access were described by participants. These models varied by disease state, available human resources, and medication. Clinics and specialty pharmacies were not fully aware of the others' systems and contributions to the specialty medicine access process. Perceptions of inefficient communication resulted in frustration and higher perceived work burden. CONCLUSION: There is not a single streamlined pathway for clinics and patients to access specialty medicines in health systems that do not own their own specialty pharmacies. The current system architecture can lead to duplicative work, challenges in communication, and other inefficiencies. Future interventions should focus on streamlining communications between specialty pharmacies, clinics, manufacturers, and payors to create the most efficient access to specialty medicines.

Association Between Market Competition and Prices of Generic Topical Dermatology Drugs.

Importance: During the last decade, increases in drug prices for commonly prescribed dermatologic medications have outpaced the rate of inflation, national health care growth, and reimbursements. Among nondermatologic medications, studies have shown a role for robust generic market competition in reducing drug prices. The association between competition and the costs of topical dermatologic generic drugs has not been evaluated. Objective: To characterize the association between changes in drug price and the number of US Food and Drug Administration (FDA)-approved manufacturers among the most commonly used topical dermatologic generic products. Design, Setting, and Participants: This retrospective cost analysis of the most commonly prescribed topical dermatologic generic drugs used cumulative annual claims data from the Medicare Part D Prescriber Public User File to identify 597 dermatologist-prescribed drugs with more than 10 claims. The number of manufacturers and the price per unit were identified from the FDA Orange Book and the National Average Drug Acquisition Cost (NADAC) database, respectively, for 2013 through 2016. Drugs that were nondermatologic, were not topically administered, were missing NADAC data, were lacking a generic formulation, or had fewer than 400 claims were excluded. Main Outcomes and Measures: Primary outcomes included per-unit drug price and number of FDA-approved manufacturers. Pricing measures were adjusted for inflation and are reported in 2016 dollars. Results: The present analysis included 116 topical dermatologic generic formulations, representing 70.5% of the total Medicare Part D dermatologist-coded claims from 2015. Drug formulations with 1 to 2 manufacturers during the study period sustained a median percentage increase in price of 12.7%, whereas those with more than 6 manufacturers had a median percentage decrease in price of 20.5%. Formulations with 1 to 2 manufacturers had a 20.6%, 19.5%, and 33.2% higher percentage increase in price than those with 3 to 4 manufacturers, 5 to 6 manufacturers, and more than 6 manufacturers, respectively. There was a statistically significant inverse association between the percentage change in drug price and median number of manufacturers (Spearman correlation coefficient, -0.26; P = .005). Conclusions and Relevance: The negative association between the change in drug price and the median number of manufacturers of generic topical dermatologic drugs indicates a role for market competition in controlling the costs of generic drug prices within dermatology. These findings support policies that facilitate robust market competition among topical dermatologic generic drugs produced by a limited number of manufacturers.