Objectives. To determine if de facto postpartum Medicaid extension during the Families First Coronavirus Response Act (FFCRA) reduced immigrant versus US-born inequities in uninsurance. Methods. We assessed self-reported uninsurance at 2 to 6 months postpartum among people with Medicaid-paid births using the New York City Pregnancy Risk Assessment Monitoring System (PRAMS), comparing immigrant and US-born people. We created a pre-FFCRA cohort of 2611 births from 2016 to 2019 and a post-FFCRA implementation cohort of 1197 births from 2020 to 2021. We calculated risk differences using log binomial regression. Results. Self-reported postpartum uninsurance among immigrants decreased from 13.6% to 9.3% after FFCRA (adjusted risk difference = -4.9%; 95% confidence interval = -7.8%, -2.0%). Immigrant versus US-born inequities in postpartum uninsurance decreased except among Hispanic birthing people, among whom 1 in 6 reported they were uninsured during FFCRA, despite continued eligibility. Conclusions. De facto postpartum Medicaid extension decreased immigrant inequities in insurance coverage, but Hispanic immigrants may have been unaware of continued coverage. Public Health Implications. Postpartum Medicaid extension policies that are inclusive of all immigrants may decrease inequities, but community-integrated implementation is needed to raise awareness of coverage and advance postpartum maternal health equity. (Am J Public Health. 2025;115(5):732-735. https://doi.org/10.2105/AJPH.2024.307968).
Background Prior research suggests clinical effects of glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) and sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) are mediated by changes in glycated hemoglobin, body weight, systolic blood pressure, hematocrit, and urine albumin‐creatinine ratio. We aimed to confirm these findings using a meta‐analytic approach. Methods and Results We updated a systematic review of 9 GLP‐1RA and 13 SGLT2i trials and summarized longitudinal mediator data. We obtained hazard ratios (HRs) for cardiovascular, renal, and mortality outcomes. We performed linear mixed‐effects modeling of LogHRs versus changes in potential mediators and investigated differences in meta‐regression associations among drug classes using interaction terms. HRs generally became more protective with greater glycated hemoglobin reduction among GLP‐1RA trials, with average HR improvements of 20% to 30%, reaching statistical significance for major adverse cardiovascular events (ΔHR, 23%; P=0.02). Among SGLT2i trials, associations with HRs were not significant and differed from GLP1‐RA trials for major adverse cardiovascular events (Pinteraction=0.04). HRs for major adverse cardiovascular events, myocardial infarction, and stroke became less efficacious (ΔHR, −15% to −34%), with more weight loss for SGLT2i but not for GLP‐1RA trials (ΔHR, 4%−7%; Pinteraction<0.05). Among 5 SGLT2i trials with available data, HRs for stroke became less efficacious with larger increases in hematocrit (ΔHR, 123%; P=0.09). No changes in HRs by systolic blood pressure (ΔHR, −11% to 9%) and urine albumin‐creatinine ratio (ΔHR, −1% to 4%) were found for any outcome. Conclusions We confirmed increased efficacy findings for major adverse cardiovascular events with reduction in glycated hemoglobin for GLP1‐RAs. Further research is needed on the potential loss of cardiovascular benefits with increased weight loss and hematocrit for SGLT2i.
Cancer screenings aid in the early detection of cancer and can help reduce cancer-related mortality. The current model of care for cancer screening is often siloed, based on the targeted cancer site. We tested the acceptability of a new model of care, called the One-Stop-Shop Cancer Screening Clinic, that centralizes cancer screenings and offers patients the option to complete all their recommended cancer screenings within one to two visits. We administered surveys to 59 community members and 26 healthcare providers to gather feedback about the One-Stop-Shop model of care. Both community members and providers identified potential benefits (e.g., decreased patient burden, increased completion of cancer screenings) and also potential challenges (e.g., challenges with workflow and timing of care) of the model of care. The results of the study support the acceptability of the model of care. Of the community members surveyed, 89.5% said, if offered, they would be interested in participating in the One-Stop-Shop Cancer Screening Clinic. Future studies are needed to formally evaluate the impact and cost effectiveness of the One-Stop-Shop Cancer Screening Clinic.
Multi-cancer early detection (MCED) tests are blood-based tests designed to screen for signals of multiple cancers. There is growing interest and investment in examining the potential benefits and applications of MCED tests. If MCED tests are shown to have clinical utility, it is important to ensure that all people—regardless of their demographic or socioeconomic background—equitably benefit from these tests. Unfortunately, with health care innovation, such considerations are often ignored until after inequities emerge. We urge for-profit companies, scientists, clinicians, payers, and government agencies to prioritize equity now—when MCEDs are still being developed and researched. In an effort to avoid creating and exacerbating cancer inequities, we propose 9 equity considerations for MCEDs.
Value-based care initiatives require accurate quantification of resource utilization. This study explores hospital resource documentation performance for total knee and hip arthroplasty (TKA, THA) implants and how this may differ between hospitals. This retrospective study utilized the Premier discharge database, years 2006 to 2020. TKA/THA cases were categorized into 5 tiers based upon the completeness of implant component documentation: Platinum, Gold, Silver, Bronze, Poor. Correlation between TKA and THA documentation performance (per-hospital percentage of Platinum cases) was assessed. Logistic regression analyses measured the association between hospital characteristics (region, teaching status, bed size, urban/rural) and satisfactory documentation. TKA/THA implant documentation performance was compared to documentation for endovascular stent procedures. Individual hospitals tended to have very complete (Platinum) or very incomplete (Poor) documentation for both TKA and THA. TKA and THA documentation performance were correlated (correlation coefficient = .70). Teaching hospitals were less likely to have satisfactory documentation for both TKA ( P = .002) and THA ( P = .029). Documentation for endovascular stent procedures was superior compared to TKA/THA. Hospitals’ TKA and THA-related implant documentation performance is generally either very proficient or very poor, in contrast with often well-documented endovascular stent procedures. Hospital characteristics, other than teaching status, do not appear to impact TKA/THA documentation completeness.
Me & You: Building Healthy Relationships (Me & You) is a multilevel, technology-enhanced adolescent dating violence (DV) prevention program that aimed to reduce DV among ethnic-minority, early adolescent, urban youth. A group-randomized control trial of Me & You, conducted with 10 middle schools from a large urban school district in Southeast Texas in 2014–2015, found it to be effective in reducing DV perpetration and decreasing some forms of DV victimization. Economic evaluations of DV interventions are extremely limited, despite calls for more economic analyses to be incorporated in research. We help fill this gap by evaluating the cost-effectiveness from the payer and societal perspectives of implementing the Me & You program. Using cost data collected alongside the Me & You group-randomized trial, we computed incremental cost-effectiveness ratios. Our primary outcome was “any DV perpetrated” within 12 months of the intervention. We conducted a cost–benefit analysis beyond the intervention endpoint by using literature estimates of per-victim lifetime costs of DV. We performed sensitivity analyses to assess effects of uncertain parameters. Under the base-case scenario, the cost of the Me & You curriculum compared to the standard curriculum was $103.70 per-student from the societal perspective, and the effectiveness was 34.84 perpetrations averted, implying an incremental cost per perpetration averted of $2.98, which ranged from $0.48 to $73.24 in sensitivity analysis. Thus, we find the Me & You curriculum is cost-effective and cost-saving in most scenarios. Policymakers should carefully consider school-based DV prevention programs, and cost data should be regularly collected in adolescent prevention program evaluations.
Objective Eligibility for glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) has been expanded to patients with diabetes at lower cardiovascular risk, but it is not clear whether expected treatment benefits differ by risk levels. We investigated whether patients with varying risks differ in cardiovascular and renal benefits from GLP-1RAs and SGLT2i using meta-analysis and meta-regression. Research Design and Methods We updated searches of recent meta-analyses using PubMed through November 7, 2022. We included reports of confirmatory randomized trials of GLP-1RA and SGLT2i in adult patients with safety or efficacy endpoint data. We extracted hazard ratio (HR) and event rate data for mortality, cardiovascular, and renal outcomes. Results We analyzed 9 GLP-1RA and 13 SGLT2i trials comprising 154,649 patients. Summary HRs were significant for cardiovascular mortality (GLP-1RA: 0.87; SGLT2i: 0.86), major adverse cardiovascular events (0.87; 0.88), heart failure (0.89; 0.70), and composite renal (0.84; 0.65) outcomes. For stroke, efficacy was significant for GLP-1RAs (0.84), but not for SGLT2i (0.92). We did not find statistically significant associations between control arm cardiovascular mortality rates and HRs. Five-year absolute risk differences ranged from -4.25% to -0.80%, with larger reductions (11.6%) for heart failure with SGLT2i in high risk (p for slope <.001). For GLP1-RAs, associations were nonsignificant. Conclusions Relative effects of novel diabetes drugs are preserved across baseline cardiovascular risk, whereas absolute benefits increase at higher risks, particularly regarding heart failure. Our findings suggest a need for baseline risk assessment tools to identify variation in absolute treatment benefits and improve decision-making.
Background: Prior research suggests cardiovascular (CV) benefits of glucose-lowering interventions may be mediated by changes in hemoglobin A1c (HbA1c), bodyweight, systolic blood pressure (SBP), hematocrit, and urine albumin-creatinine ratio (uACR). We evaluated the heterogeneity of CV benefits by these potential mediators for sodium-glucose transporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1RAs) using a meta-analytic approach. Methods: We performed a systematic review and meta-regression analyses of 12 SGLT2i and 9 GLP-1RA CV outcome trials using linear mixed models of treatment efficacy measured as log hazard ratios (HRs) vs changes in potential mediators. We extracted follow-up mediator data for treatment and control, preferably at 12 months post randomization. Outcomes included MI, stroke, and MACE (a composite of MI, stroke, or CV death). We investigated slope differences between drug classes using interaction terms and likelihood-ratio tests. Results: Treatment efficacy for MACE improved with more HbA1c reduction among GLP-1RA (slope .26; P slope .02) but not among SGLT2i trials (slope -.22; P slope .39; P interaction .06), see Figure . Treatment efficacy for MACE, MI, and stroke decreased with more weight loss for SGLT2i (slope –.17, –.29, –.39; P slope <.05) but not for GLP-1RA trials (slope .05, .03, .07; P slope .30, .62, .32). Slopes differed significantly between drug classes: P interaction <.05. For stroke, we observed a trend of less treatment efficacy with increases in hematocrit among five SGLT2i trials with available data (slope .96; P slope .07). We did not find any indication of mediation effects by SBP and uACR for SGLT2i or GLP-1RAs (slopes -.11 -.07; P slopes ≥ .05). Conclusion: We confirm previous findings of increased CV benefits with reductions in HbA1c for GLP1-RAs. Further research is needed to investigate the potential loss of SGLT2i efficacy with greater weight loss and increase in hematocrit.
Objective: This study assessed barriers and facilitators to telehealth utilization among patients living in New York City public housing with chronic conditions and a gap in clinical care. Methods: Community health workers performed outreach to eligible patients by telephone between January and March 2021. Consenting respondents answered questions about telehealth barriers, including internet and cell phone access, ownership of digital devices, comfort with using digital devices, comfort with telehealth, cost, awareness, and availability of written materials in patients' preferred language. We obtained demographic and medical information from patients' electronic health records. We used multivariable logistic regression to estimate the association of barriers with the odds of self-reported prior telehealth utilization. Results: A total of 304 consenting patients participated in the program. The average patient had 3.1 telehealth barriers; 76% reported at least one barrier. Regression analysis showed sizable reductions in prior telehealth utilization associated with the barriers of unlimited cell phone minutes (odds ratio [OR]: 0.21 [0.05-0.88], p = 0.033), technological comfort (OR: 0.33 [0.13-0.82], p = 0.016), conceptual comfort with telehealth (OR: 0.15 [0.04-0.54], p = 0.004), and materials in the patient's preferred language (OR: 0.23 [0.07-0.79], p = 0.02). Discussion: With a high prevalence of telehealth barriers, patients with limited income, a chronic condition, and a care gap may benefit from greater technological access and supportive programs for awareness, telehealth comfort, and navigation support. Addressing telehealth barriers could increase the quality of medical care and improve health outcomes for this population.
Noncitizen immigrants are often excluded from accessing critical safety-net programs, such as Medicaid. Access to health care plays a central role in current policy debates on maternal health. Yet, immigrant exclusions are rarely considered in maternal health policy research. Through open-ended interviews with 31 policymakers, researchers, and program administrators, we examined state variations in approaches to providing care for pregnant, post, and intrapartum immigrant women. We found four themes: (a) a patchwork safety-net exists that provides some access to immigrants ineligible for Medicaid; (b) patchwork coverage leads to patchwork care, which can contribute to maternal health inequities; (c) immigrant Medicaid policy is assembled along a hierarchy of deservingness based on documentation status; (d) Trump-era public charge rules and political climate may have a substantial chilling effect on benefit uptake regardless of eligibility. We discuss implications for efforts to expand Medicaid postpartum and address the maternal health crisis.
Objective: To explore overall trends as well as racial/ethnic disparities in utilization of different telehealth modalities (telephone vs. televideo) at federally qualified health centers (FQHCs) during the COVID-19 pandemic.Methods: Using electronic health record data from a large New York-based FQHC system, we aggregated (separately) Behavioral Health and Family Practice visits per month occurring in-person, by telephone, or by televideo and graphed monthly trends in visits across the pre-pandemic, peak-pandemic, and post-peak-pandemic periods. We calculated fractions of visits conducted by modality for each patient demographic (race/ethnicity, primary language, age, gender, insurance type, and geography) and conducted bivariate assessments to test relationships between patient characteristics and modality.Results: Our data contained 121,072 unique patients and 811,105 visits overall. Telehealth use peaked in April 2020 but continued to account for a significant fraction of FQHC visits-nearly 25% (N = 4,908) of monthly Family Practice visits and a massive 98% (N = 14,173) of Behavioral Health visits as late as June 2021. Of all telehealth visits, nearly half were by telephone. Moreover, demographic factors differed between FQHC patients using telephone visits versus those using televideo: Black, non-English speaking, older, and Medicaid patients had significantly higher utilization of telephone visits than televideo visits (e.g., 25.9% of all Black patients' visits were via telephone vs. 17.1% via televideo; p < 0.001). In contrast, younger, Asian, and privately insured patients had significantly higher televideo visits.Conclusions: Our results suggest that telephone visits remain critical to the provision of health care for FQHC patients. They also suggest that disparities extend beyond the telehealth versus in-person dichotomy and inequities exist even within the type of telehealth used. This has implications for patient health, FQHC quality outcomes, as well as optimal Medicaid telehealth reimbursement policy.
Background: Prior meta-analyses suggest that the relative cardiovascular (CV) risk reduction by sodium glucose transporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1RAs) is larger in established CV disease. We investigated heterogeneity of treatment benefits along the continuum of CV risk. Methods: We performed meta-regression analyses of CV outcome trials (9 on SGLT2i, 8 on GLP-1RAs) using log hazard ratios and CV mortality rates in the control group as proxy for baseline risk and background treatment profile of trial populations. We evaluated effects for all-cause mortality, major adverse cardiovascular events (MACE) , and heart failure. We computed absolute risk difference (ARD) in 5-year CV mortality for each trial and studied its relationship with baseline risk. Results: We did not find statistically significant associations between baseline risk and log hazard ratios for any outcome (slope range -.to .21; p>.10) . The ARD for 5-year CV mortality increased significantly with higher baseline risk for SGLT2i, to a predicted 2.78% in high risk (Figure) . For GLP1-RA trials, this relationship was not significant likely due to less variation in baseline risk. Conclusion: Absolute, but not relative, CV benefits of novel diabetes drugs depend on baseline risk, which is important in guiding treatment decisions based on risk stratification. Disclosure J.M.Rodriguez-valadez: None. W.Max: None. K.Fleischmann: None. B.Ferket: None. M.Hunink: None. U.Masharani: Advisory Panel; Ryse Health, Research Support; Clementia Pharmaceuticals. J.Yeboah: None. M.Park: Advisory Panel; Otsuka America Pharmaceutical, Inc., Reata Pharmaceuticals, Inc., Other Relationship; Merck & Co., Inc. L.Li: None. E.Weber: None. Y.Li: None. A.Berkalieva: None. Funding Research reported in this abstract was supported by the National Heart, Lung, And Blood Institute (NHLBI) of the National Institutes of Health under award number: R01HL153456. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
OBJECTIVE:Exclusive breastmilk feeding during the delivery hospitalization, a Joint Commission indicator of perinatal care quality, is associated with longer-term breastfeeding success. Marked racial and ethnic disparities in breastfeeding exclusivity and duration existed prior to COVID-19. The pandemic, accompanied by uncertainty regarding intrapartum and postpartum safety practices, may have influenced disparities in infant feeding practices. Our objective was to examine whether the first wave of the COVID-19 pandemic in New York City was associated with a change in racial and ethnic disparities in exclusive breastmilk feeding during the delivery stay. METHODS:We conducted a cross-sectional study of electronic medical records from 14,964 births in two New York City hospitals. We conducted a difference-in-differences (DID) analysis to compare Black-white, Latina-white, and Asian-white disparities in exclusive breastmilk feeding in a pandemic cohort (April 1-July 31, 2020, n=3122 deliveries) to disparities in a pre-pandemic cohort (January 1, 2019-February 28, 2020, n=11,842). We defined exclusive breastmilk feeding as receipt of only breastmilk during delivery hospitalization, regardless of route of administration. We ascertained severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection status from reverse transcription-polymerase chain reaction tests from nasopharyngeal swab at admission. For each DID model (e.g. Black-white disparity), we used covariate-adjusted log binomial regression models to estimate racial and ethnic risk differences, pandemic versus pre-pandemic cohort risk differences, and an interaction term representing the DID estimator. RESULTS:Exclusive breastmilk feeding increased from pre-pandemic to pandemic among white (40.8% to 46.6%, p<0.001) and Asian (27.9% to 35.8%, p=0.004) women, but not Black (22.6% to 25.3%, p=0.275) or Latina (20.1% to 21.4%, p=0.515) women overall. There was an increase in the Latina-white exclusive breastmilk feeding disparity associated with the pandemic (DID estimator=6.3 fewer cases per 100 births (95% CI=-10.8, -1.9)). We found decreased breastmilk feeding specifically among SARS-CoV-2 positive Latina women (20.1% pre-pandemic vs. 9.1% pandemic p=0.013), and no change in Black-white or Asian-white disparities. CONCLUSIONS:We observed a pandemic-related increase in the Latina-white disparity in exclusive breastmilk feeding, urging hospital policies and programs to increase equity in breastmilk feeding and perinatal care quality during and beyond this health emergency.
Purpose HDR brachytherapy, such as tandem & ovoids (T&O), is a crucial component of definitive care for locally advanced cervical cancer in the U.S. Its cost and those of other healthcare services are often unknown or unclear at the time of care. Upfront, accessible price transparency may help address patients' financial concern. Effective 1/1/2021, the Hospital Price Transparency Rule (45 CFR Part 180) requires all U.S. hospitals to annually release hospital-related prices. Our project seeks to evaluate the availability, variation, and factors associated with hospital-negotiated prices of T&O in the U.S. Materials and Methods We conducted a cross-sectional study of U.S. hospitals in CMS's Care Compare, linking to Turquoise Health (hospital-negotiated prices), Healthcare Cost Report Information System (hospital characteristics), and Social Vulnerability Indices. We identified six T&O-related CPT codes (77280, 77470, 77370, 77318, 77771, and 57155), with their negotiated-prices estimated by payer type. We used regression models to estimate the association of hospital characteristics with commercial prices. Results A majority of the hospitals are non-profit (61%), acute care hospitals (69%), and/or non Graduate Medical Education (GME)-participating (72%), with a median operating margin of 0.03 (IQR:-0.03, 0.09), asset-to-liability ratio of 1.79 (1.06, 2.96), and social vulnerability index of 0.53 (0.29, 0.74). 17-28% of hospitals reported T&O-related prices depending on the CPT code. Prices were typically greater for commercial insurance compared to Medicare/Medicaid (+$335-362 simulation, +$550-798 MD plan, +$224-747 physics plan, +$1160-1707 treatment; P<0.001, all tests), except for CPT code 57155 (treatment) where the Medicare price was greater than commercial insurance's price (+403; P<0.001). Table 1 shows the adjusted analysis of commercial prices. Conclusion Our analysis shows that negotiated T&O prices in the U.S. is typically higher for commercial insurances, hospitals with higher operating margins, and non GME participating hospitals; it is typically lower for critical access hospitals. Socially vulnerable areas do not consistently enjoy lower prices. Further price transparency research and advocacy could better elucidate this area, thereby promoting economic competition and lower the price for curative cervical cancer treatment.
e13633 Background: The Hospital Price Transparency Rule, effective 1/1/2021, requires hospitals to publish payer-specific negotiated charges and cash prices. Given differences in insurance coverage for screening versus diagnostic mammography, we evaluate factors associated with these payer-negotiated charges. Methods: We conducted a cross-sectional study of U.S. acute care and critical access hospitals in CMS’ Care Compare linked to Turquoise Health (payer-negotiated charges), Healthcare Cost Report Information System (hospital characteristics) and Social Vulnerability Indices by county. Negotiated charges for mammography (CPT: screening 77067; diagnostic unilateral 77065, bilateral 77066) were estimated by payer type (self-pay, managed Medicare/Medicaid, or commercial). Adjusted models estimated commercial charges accounting for hospital factors. Results: Most hospitals (N=4212) were non-profits (61%) and acute care hospitals (69%). Median operating margin was .03 (IQR:-.03, .09), asset-to-liability ratio was 1.79 (1.06, 2.96), and social vulnerability index was .53 (.29, .74). 48-50% reported mammography charges. Charges were greater for commercial insurance compared to Medicare/Medicaid (+$55-$82 screening, +$122-$132 bilateral diagnostic; P<.001, all tests). Charges for commercial insurance were similar to self-pay for bilateral screening (p=.41) and diagnostic (p=.08) mammography. See Table for adjusted analysis of commercial charges. Conclusions: Our analysis showed U.S. negotiated mammography charges are similar for self-pay and commercial payers. Commercial charges are higher at private hospitals and those with higher operating margins for diagnostic exams, and lower in socially vulnerable areas. Price transparency may promote competition to lower healthcare prices and highlight any financial toxicity associated with self-pay charges. [Table: see text]
Background: Prior research suggests cardiovascular (CV) benefits of glucose-lowering interventions are mediated by bodyweight changes, either through changes in fluid retention or body fat mass. For example, a meta-regression analysis of 30 randomized trials on glucose lowering interventions showed a 1 kg weight decrease was associated with a 5.9% (95% CI 3.9 - 8.0) relative reduction of heart failure risk (Ghosh et al., 2020) . We evaluated heterogeneity of CV benefits by weight change for two novel diabetes medications that lower weight: sodium glucose transporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1RAs) . Methods: We performed meta-regression analyses of published CV outcome trials (6 on SGLT2i, 8 on GLP-1RAs) using reported hazard ratios (HRs) and bodyweight difference across study arms. Dependent variables included log HRs for 1) all-cause mortality, 2) major adverse cardiovascular events (MACE) , and 3) hospitalization for heart failure. We ran linear mixed models with weights equal to the inverse of the variance of each study’s log HR. Results: The slopes from meta-regressions by pooling all trials and by drug type (Figure) were not significant and in some cases demonstrated an inverse relationship (SGLT2i for MACE, slope= -.102; p= .04) . Conclusion: We could not reproduce findings of increased CV benefits with more weight loss for SGLT2i and GLP-1RAs. Disclosure J.M.Rodriguez-valadez: None. W.Max: None. K.Fleischmann: None. B.Ferket: None. M.Hunink: None. U.Masharani: Advisory Panel; Ryse Health, Research Support; Clementia Pharmaceuticals. J.Yeboah: None. M.Park: Advisory Panel; Otsuka America Pharmaceutical, Inc., Reata Pharmaceuticals, Inc., Other Relationship; Merck & Co., Inc. L.Li: None. E.Weber: None. Y.Li: None. A.Berkalieva: None. Funding Research reported in this publication was supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number R01HL153456. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.