Publications by authors named "Andrea B Troxel"

214 Publications

The National Institutes of Health COVID-19 NeuroDatabank and NeuroBiobank: A National Resource for Learning, Discovery, and Progress.

Front Neurol 2020 15;11:615061. Epub 2021 Jan 15.

Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, MD, United States.

Patients suffering from COVID-19 experience a wide range of symptoms and sequelae, including increasingly recognized neurological problems. A concerted effort is necessary to identify and characterize these issues, whether newly appearing as a result of COVID-19 disease or exacerbations of underlying conditions. A national resource to collect information and/or biospecimens regarding neurological complications of COVID-19 offers an opportunity for broad representation, harmonization, and rapid learning, all while ensuring robust protection of confidential information through the use of global unique identifiers to protect patient privacy.
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http://dx.doi.org/10.3389/fneur.2020.615061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843568PMC
January 2021

Acceptability of a community health worker intervention to improve the oral health of older Chinese Americans: A pilot study.

Gerodontology 2021 Mar 27;38(1):117-122. Epub 2020 Dec 27.

Division of Health and Behavior, Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA.

Objective: To evaluate the acceptability of a community health worker (CHW) intervention designed to improve the oral health of low-income, urban Chinese immigrant adults.

Background: Given that both dental caries and periodontitis are behaviourally mediated, biofilm-based diseases that are largely preventable with attention to regular oral hygiene practices and preventive dental visits, strategies to arrest or even heal carious lesions and high-quality maintenance care and plaque control without the need to resort to aerosol-generating surgical approaches are evidence-based best practices. Older immigrants have poorer oral health than older US-born natives, motivating the need for delivery of more effective and affordable services to this vulnerable population.

Materials And Methods: CHWs were trained by the NYU College of Dentistry dental hygienist faculty members using dental models and flip charts to instruct patients on proper brushing and flossing techniques. In addition, they discussed the presented oral health promotion information one-on-one with patients, addressed any expressed concerns and encouraged prevention of oral conditions through regular dental visits and brushing with fluoride toothpaste.

Results: More than 98% of the 74 older Chinese adult participants strongly agreed/agreed that the CHWs helped them to improve how they take care of their health, the CHWs answered their questions and concerns, the information and topics were informative, and the in-person demonstrations were helpful in improving oral health.

Conclusion: The health of all communities depends on access to comprehensive care, including oral health care, in the wake of COVID-19. CHW interventions are acceptable to and may reach marginalised and immigrant communities.
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http://dx.doi.org/10.1111/ger.12522DOI Listing
March 2021

Effect of Remote Monitoring on Discharge to Home, Return to Activity, and Rehospitalization After Hip and Knee Arthroplasty: A Randomized Clinical Trial.

JAMA Netw Open 2020 12 1;3(12):e2028328. Epub 2020 Dec 1.

Perelman School of Medicine, Department of Medicine, University of Pennsylvania, Philadelphia.

Importance: Hip and knee arthroplasty are the most common inpatient surgical procedures for Medicare beneficiaries in the US, with substantial variation in cost and quality. Whether remote monitoring incorporating insights from behavioral science might help improve outcomes and increase value of care remains unknown.

Objective: To evaluate the effect of activity monitoring and bidirectional text messaging on the rate of discharge to home and clinical outcomes in patients receiving hip or knee arthroplasty.

Design, Setting, And Participants: Randomized clinical trial conducted between February 7, 2018, and April 15, 2019. The setting was 2 urban hospitals at an academic health system. Participants were patients aged 18 to 85 years scheduled to undergo hip or knee arthroplasty with a Risk Assessment and Prediction Tool score of 6 to 8.

Interventions: Eligible patients were randomized evenly to receive usual care (n = 153) or remote monitoring (n = 147). Those in the intervention arm who agreed received a wearable activity monitor to track step count, messaging about postoperative goals and milestones, pain score tracking, and connection to clinicians as needed. Patients assigned to receive monitoring were further randomized evenly to remote monitoring alone or remote monitoring with gamification and social support. Remote monitoring was offered before surgery, began at hospital discharge, and continued for 45 days postdischarge.

Main Outcomes And Measures: The primary outcome was discharge status (home vs skilled nursing facility or inpatient rehabilitation). Prespecified secondary outcomes included change in average daily step count and rehospitalizations.

Results: A total of 242 patients were analyzed (124 usual care, 118 intervention); median age was 66 years (interquartile range, 58-73 years); 78.1% were women, 45.5% were White, 43.4% were Black; and 81.4% in the intervention arm agreed to receive monitoring. There was no significant difference in the rate of discharge to home between the usual care arm (57.3%; 95% CI, 48.5%-65.9%) and the intervention arm (56.8%; 95% CI, 47.9%-65.7%) and no significant increase in step count in those receiving remote monitoring plus gamification and social support compared with remote monitoring alone. There was a statistically significant reduction in rehospitalization rate in the intervention arm (3.4%; 95% CI, 0.1%-6.7%) compared with the usual care arm (12.2%; 95% CI, 6.4%-18.0%) (P = .01).

Conclusions And Relevance: In this study, the remote monitoring program did not increase rate of discharge to home after hip or knee arthroplasty, and gamification and social support did not increase activity levels. There was a significant reduction in rehospitalizations among those receiving the intervention, which may have resulted from goal setting and connection to the care team.

Trial Registration: ClinicalTrials.gov Identifier: NCT03435549.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.28328DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753899PMC
December 2020

Sleep medication use and incident dementia in a nationally representative sample of older adults in the US.

Sleep Med 2021 Mar 11;79:183-189. Epub 2020 Nov 11.

Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.

Background: Sleep difficulties are common among older adults, and clinical management of sleep difficulties commonly includes sleep medication (pharmacological and non-pharmacological). Our research examines sleep medication use and incident dementia over 8 years using nationally representative data from older adults ages 65 years and older in the United States.

Methods: We used data collected from the National Health and Aging Trends Study (NHATS), a nationally-representative longitudinal study of Medicare beneficiaries. Routine sleep medication use (pharmacological and non-pharmacological) was defined as use "most nights" or "every night." Participants were screened for dementia with validated instruments that assessed memory, orientation, and executive function. We conduct prospective analyses to examine the relationship between routine sleep medication use and incident dementia using Cox proportional hazards modeling and estimated survival curves. Analyses controlled for age, sex, marital status, education, and chronic conditions.

Results: Among respondents at baseline (n = 6373), most participants (21%) were age 70-74 years of age. Participants were 59% female and the sample comprised non-Hispanic White (71%). At baseline, 15% of our study sample reported using sleep medication routinely, which is representative of 4.6 million older adults in the US. Covariate adjusted proportional hazard models revealed that routinely using sleep medication was associated with incident dementia (HR = 1.30, 95%CI: 1.10 to 1.53, p < 0.01).

Conclusions: Our study observed, in a nationally representative study of older adults in the US across 8 years of data that 15% of older adults report routinely using sleep medication, yet routine use of sleeping medication was associated with incident dementia across the follow-up interval. Future research may examine behavioral approaches to improving sleep among older adults.
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http://dx.doi.org/10.1016/j.sleep.2020.11.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7925354PMC
March 2021

A Propensity-Matched Cohort Study of Tocilizumab in Patients With Coronavirus Disease 2019.

Crit Care Explor 2020 Nov 16;2(11):e0283. Epub 2020 Nov 16.

Department of Pulmonary and Critical Care Medicine, NYU Langone Health, New York, NY.

To determine the impact of tocilizumab, a monoclonal antibody against the interleukin 6 receptor, on survival in patients with coronavirus disease 2019.

Design: Observational cohort study of patients hospitalized with coronavirus disease 2019 between March 1, 2020, and April 24, 2020. A propensity-matched (1:1) analysis was used to compare patients who received tocilizumab to controls who did not. Competing risk survival analysis was used to determine the primary outcome of time to mortality, and adjusted log-linear and logistic regression for secondary outcomes.

Setting: Three hospitals within the NYU Langone Health system in New York.

Patients: Consecutive adult patients hospitalized with coronavirus disease 2019.

Intervention: Tocilizumab 400-mg IV once in addition to standard of care or standard of care alone.

Measurements And Main Results: Data from 3,580 severe acute respiratory syndrome coronavirus 2 positive qualifying hospitalized patients were included, of whom 497 (13.9%) were treated with tocilizumab. In the analysis of tocilizumab-treated patients and matched controls, fewer tocilizumab-treated patients died (145/497, 29.2%) than did controls (211/497, 42.4%). In the adjusted competing risk regression model, tocilizumab therapy was associated with improved survival relative to controls (hazard ratio = 0.24, 95% CI = 0.18-0.33, < 0.001). Tocilizumab-treated patients and controls had similar adjusted time to discharge from hospital (hazard ratio = 0.96, 95% CI = 0.78-1.17, = 0.67). However, they had longer adjusted ICU length of stay (rate ratio = 3.1, 95% CI = 2.5-3.7, < 0.001) and a higher adjusted infection rate (odds ratio = 4.18, 95% CI = 2.72-6.52, < 0.001) than controls.

Conclusions: Tocilizumab therapy was associated with significantly improved survival in coronavirus disease 2019 patients. This survival benefit was associated with increased ICU length of stay and increased infection rate, even as more patients in the tocilizumab group were rescued from rapid death. A prospective, randomized, placebo-controlled trial is needed to confirm these findings.
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http://dx.doi.org/10.1097/CCE.0000000000000283DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7671881PMC
November 2020

Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists.

Med Decis Making 2021 01 20;41(1):9-20. Epub 2020 Nov 20.

Department of Medical Ethics and Health Policy, Perelman School of Medicine, and Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA, USA.

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.
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http://dx.doi.org/10.1177/0272989X20973160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772275PMC
January 2021

Analysis of multicenter clinical trials with very low event rates.

Trials 2020 Nov 9;21(1):917. Epub 2020 Nov 9.

Palliative and Advanced Illness Research (PAIR) Center, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 304 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104-6021, USA.

Introduction: In a five-arm randomized clinical trial (RCT) with stratified randomization across 54 sites, we encountered low primary outcome event proportions, resulting in multiple sites with zero events either overall or in one or more study arms. In this paper, we systematically evaluated different statistical methods of accounting for center in settings with low outcome event proportions.

Methods: We conducted a simulation study and a reanalysis of a completed RCT to compare five popular methods of estimating an odds ratio for multicenter trials with stratified randomization by center: (i) no center adjustment, (ii) random intercept model, (iii) Mantel-Haenszel model, (iv) generalized estimating equation (GEE) with an exchangeable correlation structure, and (v) GEE with small sample correction (GEE-small sample correction). We varied the number of total participants (200, 500, 1000, 5000), number of centers (5, 50, 100), control group outcome percentage (2%, 5%, 10%), true odds ratio (1, > 1), intra-class correlation coefficient (ICC) (0.025, 0.075), and distribution of participants across the centers (balanced, skewed).

Results: Mantel-Haenszel methods generally performed poorly in terms of power and bias and led to the exclusion of participants from the analysis because some centers had no events. Failure to account for center in the analysis generally led to lower power and type I error rates than other methods, particularly with ICC = 0.075. GEE had an inflated type I error rate except in some settings with a large number of centers. GEE-small sample correction maintained the type I error rate at the nominal level but suffered from reduced power and convergence issues in some settings when the number of centers was small. Random intercept models generally performed well in most scenarios, except with a low event rate (i.e., 2% scenario) and small total sample size (n ≤ 500), when all methods had issues.

Discussion: Random intercept models generally performed best across most scenarios. GEE-small sample correction performed well when the number of centers was large. We do not recommend the use of Mantel-Haenszel, GEE, or models that do not account for center. When the expected event rate is low, we suggest that the statistical analysis plan specify an alternative method in the case of non-convergence of the primary method.
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http://dx.doi.org/10.1186/s13063-020-04801-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7654615PMC
November 2020

Assessing The Effectiveness Of Peer Comparisons As A Way To Improve Health Care Quality.

Health Aff (Millwood) 2020 May;39(5):852-861

Ezekiel J. Emanuel is the Diane V. S. Levy and Robert M. Levy University Professor, chair of the Department of Medical Ethics and Health Policy, and vice provost for global initiatives, all at the University of Pennsylvania.

Policy makers are increasingly using performance feedback that compares physicians to their peers as part of payment policy reforms. However, it is not known whether peer comparisons can improve broad outcomes, beyond changing specific individual behaviors such as reducing inappropriate prescribing of antibiotics. We conducted a cluster-randomized controlled trial with Blue Cross Blue Shield of Hawaii to examine the impact of providing peer comparisons feedback on the quality of care to primary care providers in the setting of a shift from fee-for-service to population-based payment. Over 74,000 patients and eighty-eight primary care providers across sixty-three sites were included over a period of nine months in 2016. Patients in the peer comparisons intervention group experienced a 3.1-percentage-point increase in quality scores compared to the control group-whose members received individual feedback only. This result underscores the effectiveness of peer comparisons as a way to improve health care quality, and it supports Medicare's decisions to provide comparative feedback as part of recently implemented primary care and specialty payment reform programs.
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http://dx.doi.org/10.1377/hlthaff.2019.01061DOI Listing
May 2020

Treatment with Zinc is Associated with Reduced In-Hospital Mortality Among COVID-19 Patients: A Multi-Center Cohort Study.

Res Sq 2020 Oct 26. Epub 2020 Oct 26.

Zinc impairs replication of RNA viruses such as SARS-CoV-1, and may be effective against SARS-CoV-2. However, to achieve adequate intracellular zinc levels, administration with an ionophore, which increases intracellular zinc levels, may be necessary. We evaluated the impact of zinc with an ionophore (Zn+ionophore) on COVID-19 in-hospital mortality rates. A multicenter cohort study was conducted of 3,473 adult hospitalized patients with reverse-transcriptase-polymerase-chain-reaction (RT-PCR) positive SARS-CoV-2 infection admitted to four New York City hospitals between March 10 through May 20, 2020. Exclusion criteria were: death or discharge within 24h, comfort-care status, clinical trial enrollment, treatment with an IL-6 inhibitor or remdesivir. Patients who received Zn+ionophore were compared to patients who did not using multivariable time-dependent cox proportional hazards models for time to in-hospital death adjusting for confounders including age, sex, race, BMI, diabetes, week of admission, hospital location, sequential organ failure assessment (SOFA) score, intubation, acute renal failure, neurological events, treatment with corticosteroids, azithromycin or lopinavir/ritonavir and the propensity score of receiving Zn+ionophore. A sensitivity analysis was performed using a propensity score-matched cohort of patients who did or did not receive Zn+ionophore matched by age, sex and ventilator status. Among 3,473 patients (median age 64, 1947 [56%] male, 522 [15%] ventilated, 545[16%] died), 1,006 (29%) received Zn+ionophore. Zn+ionophore was associated with a 24% reduced risk of in-hospital mortality (12% of those who received Zn+ionophore died versus 17% who did not; adjusted Hazard Ratio [aHR] 0.76, 95% CI 0.60-0.96, P=0.023). More patients who received Zn+ionophore were discharged home (72% Zn+ionophore vs 67% no Zn+ionophore, P=0.003) Neither Zn nor the ionophore alone were associated with decreased mortality rates. Propensity score-matched sensitivity analysis (N=1356) validated these results (Zn+ionophore aHR for mortality 0.63, 95%CI 0.44-0.91, P=0.015). There were no significant interactions for Zn+ionophore with other COVID-19 specific medications. Zinc with an ionophore was associated with increased rates of discharge home and a 24% reduced risk of in-hospital mortality among COVID-19 patients, while neither zinc alone nor the ionophore alone reduced mortality. Further randomized trials are warranted.
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http://dx.doi.org/10.21203/rs.3.rs-94509/v1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605567PMC
October 2020

Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.

Open Forum Infect Dis 2020 Oct 23;7(10):ofaa446. Epub 2020 Sep 23.

Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.

Background: Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.

Methods: We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.

Results: A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance ( = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay.

Conclusions: In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.
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http://dx.doi.org/10.1093/ofid/ofaa446DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543602PMC
October 2020

Factors Associated with Up-to-Date Colonoscopy Use Among Puerto Ricans in New York City, 2003-2016.

Dig Dis Sci 2020 Oct 16. Epub 2020 Oct 16.

Department of Medicine, NYU Langone Health, 550 First Avenue, New York, NY, 10016, USA.

Background: Colorectal cancer is the second leading cause of cancer death among Hispanic Americans. Puerto Ricans are the second largest Hispanic subgroup in the USA and the largest in New York City, but little is known about predictors of colorectal cancer screening uptake in this population.

Aims: We used the New York City Community Health Survey, a population-based telephone survey, to investigate predictors of up-to-date colonoscopy use over time among Puerto Ricans aged ≥ 50 years in NYC.

Methods: We assessed the association between sociodemographic and medical factors and up-to-date colonoscopy use (defined as colonoscopy within the last 10 years) using univariable and multivariable logistic regression over six time periods: 2003-2005, 2006-2008, 2009-2010, 2011-2012, 2013-2014, and 2015-2016.

Results: On multivariable analysis, age ≥ 65 years (OR 1.64-1.93 over three periods) and influenza vaccination (OR 1.86-2.17 over five periods) were the two factors most consistently associated with up-to-date colonoscopy use. Individuals without a primary care provider (OR 0.38-0.50 over three periods) and who did not exercise (OR 0.49-0.52 over two periods) were significantly less likely to have an up-to-date colonoscopy.

Conclusions: Older age, influenza vaccination, having a primary care provider, and exercise are independent predictors of up-to-date colonoscopy use among Puerto Ricans in NYC. Interventions to improve screening colonoscopy uptake among Puerto Ricans should be targeted to those aged 50-64 years and who do not have a primary care provider.
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http://dx.doi.org/10.1007/s10620-020-06648-xDOI Listing
October 2020

A Prospective Study of Neurologic Disorders in Hospitalized Patients With COVID-19 in New York City.

Neurology 2021 01 5;96(4):e575-e586. Epub 2020 Oct 5.

From the New York University Grossman School of Medicine (J.A.F., S.S., R.L., T.F., B.F., P.M.-V., T.S., S.B., D.Y., A.G., N.M., P.P., J.G., K.M., S.A., M.B., A.A., E.V., M.O., A.K., K.L., Daniel Friedman, David Friedman, M.H., J.H., S.T., J.H., N.A.-F., P.K., A.L., A.S.L., T.Z., D.E.K., B.M.C., J.T., S.Y., K.I., E.S., D.P., M.L., T.W., A.B.T., L.B., S.G.), New YorkUniversity of Pittsburgh School of Medicine (S.H.-Y.C., E.L.F.), PAThe Ohio State University (M.M., S.M.), ColumbusMedical University of Innsbruck (R.H.), AustriaThe Johns Hopkins University School of Medicine (C.R., J.I.S., W.Z.), Baltimore, MDUniversity of Utah School of Medicine (M.S., A.d.H.), Salt Lake CityUniversity of Cambridge (D.M.), UK.

Objective: To determine the prevalence and associated mortality of well-defined neurologic diagnoses among patients with coronavirus disease 2019 (COVID-19), we prospectively followed hospitalized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients and recorded new neurologic disorders and hospital outcomes.

Methods: We conducted a prospective, multicenter, observational study of consecutive hospitalized adults in the New York City metropolitan area with laboratory-confirmed SARS-CoV-2 infection. The prevalence of new neurologic disorders (as diagnosed by a neurologist) was recorded and in-hospital mortality and discharge disposition were compared between patients with COVID-19 with and without neurologic disorders.

Results: Of 4,491 patients with COVID-19 hospitalized during the study timeframe, 606 (13.5%) developed a new neurologic disorder in a median of 2 days from COVID-19 symptom onset. The most common diagnoses were toxic/metabolic encephalopathy (6.8%), seizure (1.6%), stroke (1.9%), and hypoxic/ischemic injury (1.4%). No patient had meningitis/encephalitis or myelopathy/myelitis referable to SARS-CoV-2 infection and 18/18 CSF specimens were reverse transcriptase PCR negative for SARS-CoV-2. Patients with neurologic disorders were more often older, male, white, hypertensive, diabetic, intubated, and had higher sequential organ failure assessment (SOFA) scores (all < 0.05). After adjusting for age, sex, SOFA scores, intubation, history, medical complications, medications, and comfort care status, patients with COVID-19 with neurologic disorders had increased risk of in-hospital mortality (hazard ratio [HR] 1.38, 95% confidence interval [CI] 1.17-1.62, < 0.001) and decreased likelihood of discharge home (HR 0.72, 95% CI 0.63-0.85, < 0.001).

Conclusions: Neurologic disorders were detected in 13.5% of patients with COVID-19 and were associated with increased risk of in-hospital mortality and decreased likelihood of discharge home. Many observed neurologic disorders may be sequelae of severe systemic illness.
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http://dx.doi.org/10.1212/WNL.0000000000010979DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7905791PMC
January 2021

Implementation of a Behavioral Economics Electronic Health Record (BE-EHR) Module to Reduce Overtreatment of Diabetes in Older Adults.

J Gen Intern Med 2020 11 3;35(11):3254-3261. Epub 2020 Sep 3.

Division of Healthcare Delivery Science, Department of Population Health, New York University School of Medicine, New York, NY, USA.

Background: Intensive glycemic control is of unclear benefit and carries increased risk for older adults with diabetes. The American Geriatrics Society's (AGS) Choosing Wisely (CW) guideline promotes less aggressive glycemic targets and reduction in pharmacologic therapy for older adults with type II diabetes. Meanwhile, behavioral economic (BE) approaches offer promise in influencing hard-to-change behavior, and previous studies have shown the benefits of using electronic health record (EHR) technology to encourage guideline adherence.

Objective: This study aimed to develop and pilot test an intervention that leverages BE with EHR technology to promote appropriate diabetes management in older adults.

Design: A pilot study within the New York University Langone Health (NYULH) EHR and Epic system to deliver BE-inspired nudges at five NYULH clinics at varying time points from July 12, 2018, through October 31, 2019.

Participants: Clinicians across five practices in the NYULH system whose patients were older adults (age 76 and older) with type II diabetes.

Interventions: A BE-EHR module comprising six nudges was developed through a series of design workshops, interviews, user-testing sessions, and clinic visits. BE principles utilized in the nudges include framing, social norming, accountable justification, defaults, affirmation, and gamification.

Main Measures: Patient-level CW compliance.

Key Results: CW compliance increased 5.1% from a 16-week interval at baseline to a 16-week interval post intervention. From February 14 to June 5, 2018 (prior to the first nudge launch in Vanguard clinics), CW compliance for 1278 patients was mean (95% CI)-16.1% (14.1%, 18.1%). From July 3 to October 22, 2019 (after BE-EHR module launch at all five clinics), CW compliance for 680 patients was 21.2% (18.1%, 24.3%).

Conclusions: The BE-EHR module shows promise for promoting the AGS CW guideline and improving diabetes management in older adults. A randomized controlled trial will commence to test the effectiveness of the intervention across 66 NYULH clinics.

Nih Trial Registry Number: NCT03409523.
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http://dx.doi.org/10.1007/s11606-020-06119-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7661670PMC
November 2020

COVID-19 in Patients With Inflammatory Arthritis: A Prospective Study on the Effects of Comorbidities and Disease-Modifying Antirheumatic Drugs on Clinical Outcomes.

Arthritis Rheumatol 2020 12 25;72(12):1981-1989. Epub 2020 Oct 25.

New York University School of Medicine and NYU Langone Orthopedic Hospital, New York, New York.

Objective: To characterize the hospitalization and death rates among patients with inflammatory arthritis (IA) affected by coronavirus disease 2019 (COVID-19) and to analyze the associations of comorbidities and immunomodulatory medications with infection outcomes.

Methods: Data on clinical and demographic features, maintenance treatment, disease course, and outcomes in individuals with IA (rheumatoid arthritis and spondyloarthritis) with symptomatic COVID-19 infection were prospectively assessed via web-based questionnaire followed by individual phone calls and electronic medical record review. Baseline characteristics and medication use were summarized for hospitalized and ambulatory patients, and outcomes with the different medication classes were compared using multivariable logistic regression.

Results: A total of 103 patients with IA were included in the study (80 with confirmed COVID-19 and 23 with high suspicion of COVID-19). Hospitalization was required in 26% of the participants, and 4% died. Patients who were hospitalized were significantly more likely to be older (P < 0.001) and have comorbid hypertension (P = 0.001) and chronic obstructive pulmonary disease (P = 0.02). IA patients taking oral glucocorticoids had an increased likelihood of being admitted for COVID-19 (P < 0.001), while those receiving maintenance anticytokine biologic therapies did not.

Conclusion: Among patients with underlying IA, COVID-19 outcomes were worse in those receiving glucocorticoids but not in patients receiving maintenance anticytokine therapy. Further work is needed to understand whether immunomodulatory therapies affect COVID-19 incidence.
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http://dx.doi.org/10.1002/art.41456DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722024PMC
December 2020

Checkpoint Blockade Treatment May Sensitize Hodgkin Lymphoma to Subsequent Therapy.

Oncologist 2020 10 28;25(10):878-885. Epub 2020 Aug 28.

Division of Hematology and Medical Oncology, Perlmutter Cancer Center at NYU Langone Health, New York, New York, USA.

Background: Targeted therapies and checkpoint blockade therapy (CBT) have shown efficacy for patients with Hodgkin lymphoma (HL) in the relapsed and refractory (R/R) setting, but once discontinued owing to progression or side effects, it is unclear how successful further therapies will be. Moreover, there are no data on optimal sequencing of these treatments with standard therapies and other novel agents. In a multicenter, retrospective analysis, we investigated whether exposure to CBT could sensitize HL to subsequent therapy.

Materials And Methods: Seventeen centers across the U.S. and Canada retrospectively queried medical records for eligible patients. The primary aim was to evaluate the overall response rate (ORR) to post-CBT treatment using the Lugano criteria. Secondary aims included progression-free survival (PFS), duration of response, and overall survival (OS).

Results: Eighty-one patients were included. Seventy-two percent had stage III-IV disease, and the population was heavily pretreated with a median of four therapies before CBT. Most patients (65%) discontinued CBT owing to progression. The ORR to post-CBT therapy was 62%, with a median PFS of 6.3 months and median OS of 21 months. Post-CBT treatment regimens consisted of chemotherapy (44%), targeted agents (19%), immunotherapy (15%), transplant conditioning (14%), chemotherapy/targeted combination (7%), and clinical trials (1%). No significant difference in OS was found when stratified by post-CBT regimen.

Conclusion: In a heavily pretreated R/R HL population, CBT may sensitize patients to subsequent treatment, even after progression on CBT. Post-CBT regimen category did not impact OS. This may be a novel treatment strategy, which warrants further investigation in prospective clinical trials.

Implications For Practice: Novel, life-prolonging treatment strategies in relapsed and refractory (R/R) Hodgkin lymphoma (HL) are greatly desired. The results of this multicenter analysis concur with a smaller, earlier report that checkpoint blockade therapy (CBT) use in R/R HL may sensitize patients to their subsequent treatment. This approach may potentially enhance therapeutic options or to bridge patients to transplant. Prospective data are warranted prior to practice implementation. As more work is done in this area, we may also be able to optimize sequencing of CBT and novel agents in the treatment paradigm to minimize treatment-related toxicity and thus improve patient quality of life.
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http://dx.doi.org/10.1634/theoncologist.2020-0167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543382PMC
October 2020

Pooling Data From Individual Clinical Trials in the COVID-19 Era.

JAMA 2020 Aug;324(6):543-545

Department of Population Health, New York University Grossman School of Medicine, New York, New York.

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http://dx.doi.org/10.1001/jama.2020.13042DOI Listing
August 2020

Perceived Stress, Sexually Transmitted Infection, and Pelvic Inflammatory Disease: Examination of Differences in Associations Among Black and White Women.

Sex Transm Dis 2020 09;47(9):617-624

From the Department of Population Health, New York University School of Medicine, New York NY.

Introduction: Perceived stress is linked to poor sexual and reproductive health, but its relationship with sexually transmitted infections (STIs) is less clear. The elevated burden of stress and STI among Black women suggests a need to examine racial differences in the associations on additive and multiplicative scales.

Methods: Using data from Black and White female participants from wave IV of the National Longitudinal Study of Adolescent to Adult Health (n = 4744), we examined the association of high stress (scores ≥6 on the Perceived Stress Scale-4) with self-reported past-year chlamydia diagnosis, combined curable STI, and lifetime pelvic inflammatory disease using modified Poisson regression with robust variance to estimate prevalence ratios and prevalence differences. Models included a race-stress product-interaction term and adjusted for sociodemographic variables, prior trauma and stressors, and mental health factors.

Results: In unadjusted analyses, stress was associated with STI among Black and White women. Adjusted associations were attenuated among White women; among Black women, stress remained associated with chlamydia (adjusted prevalence ratio, 2.22; 95% confidence interval, 1.30-3.79) and curable STI (adjusted prevalence ratio, 1.59; 95% confidence interval, 1.05-2.40), corresponding to approximately 5 excess cases of each. Among White women, poverty and personality traits were the strongest confounders; among Black women, poverty, trauma, and neurotic personality traits were the strongest confounders for chlamydia, although no factors seemed to confound the association with curable STI.

Conclusions: Stress is independently linked to STI, particularly among Black women. Additional research with longitudinal data is needed to understand the role of stress on STI and address a significant health disparity.
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http://dx.doi.org/10.1097/OLQ.0000000000001232DOI Listing
September 2020

Early treatment-related neutropenia predicts response to palbociclib.

Br J Cancer 2020 09 9;123(6):912-918. Epub 2020 Jul 9.

Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.

Background: Palbociclib is highly active in oestrogen-receptor positive (ER+) metastatic breast cancer, but neutropenia is dose limiting. The goal of this study was to determine whether early neutropenia is associated with disease response to single-agent palbociclib.

Methods: Blood count and disease-response data were analysed from two Phase 2 clinical trials at different institutions using single-agent palbociclib: advanced solid tumours positive for retinoblastoma protein and advanced liposarcoma. The primary endpoint was PFS. The primary exposure variable was the nadir absolute neutrophil count (ANC) during the first two cycles of treatment.

Results: One hundred and ninety-six patients (61 breast, 135 non-breast) were evaluated between the two trials. Development of any grade neutropenia was significantly associated with longer median PFS in both the breast cancer (HR 0.29, 95% CI 0.11-0.74, p = 0.010) and non-breast cancer (HR 0.57, 95% CI 0.38-0.85, p = 0.006) cohorts. Grade 3-4 neutropenia was significantly associated with prolonged PFS in the non-breast cohort (HR 0.57, 95% CI 0.38-0.85, p = 0.006) but not in the breast cohort (HR 0.87, 95% CI 0.51-1.47, p = 0.596). Multivariate analysis yielded similar results.

Conclusions: Treatment-related neutropenia in the first two cycles was significantly and independently associated with prolonged PFS, suggesting that neutropenia may be a useful pharmacodynamic marker to guide individualised palbociclib dosing.

Clinical Trials Registration Information: Basket Trial: NCT01037790; Sarcoma Trial: NCT01209598.
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http://dx.doi.org/10.1038/s41416-020-0967-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492243PMC
September 2020

D-cycloserine augmentation of cognitive behavioral therapy for delusions: A randomized clinical trial.

Schizophr Res 2020 08 23;222:145-152. Epub 2020 Jun 23.

Department of Psychiatry, NYU Langone Health, New York, NY, United States of America; Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, United States of America. Electronic address:

Objective: D-cycloserine (DCS) promotes consolidation of extinction learning. This study extends earlier work by examining whether DCS can enhance cognitive behavioral therapy (CBT) for delusions.

Methods: Adults reporting moderate or greater delusions were randomly assigned to receive 50 mg of DCS or placebo prior to 10 weekly CBT sessions. The primary outcome was change in severity of delusions measured with the Psychotic Symptom Rating Scale delusion subscale (PSYRATS-D). Secondary outcomes included persistence of response at 3 and 6 month follow-up and the effects of DCS on memory consolidation and cognitive flexibility. Fifty-eight participants were randomized and 44 completed the trial.

Results: The DCS and placebo groups did not differ in change from baseline to end of CBT on PSYRATS-D, nor did DCS improve memory consolidation or cognitive flexibility compared to placebo. However, at the 3 month follow-up visit (week 24), 47% of participants who completed treatment with DCS reported a 20% or greater decrease on PSYRATS-D compared to 15% in the placebo group (p = .04). Change in distress across CBT sessions interacted with treatment group to predict change from baseline to week 24 in PSYRATS-D total score (p = .03) such that response at week 24 was greatest in DCS-treated participants who experienced a decrease in distress during CBT sessions.

Conclusions: DCS augmentation of CBT did not improve delusions compared to placebo during treatment; however, DCS was associated with a higher response rate at 3-month follow-up. DCS may produce a delayed therapeutic effect, associated with successful CBT sessions, but this finding requires replication.
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http://dx.doi.org/10.1016/j.schres.2020.06.015DOI Listing
August 2020

Building a National Program for Pilot Studies of Embedded Pragmatic Clinical Trials in Dementia Care.

J Am Geriatr Soc 2020 Jul;68 Suppl 2:S14-S20

Center for Aging Research, Regenstrief Institute, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Sixteen million caregivers currently provide care to more than 5 million persons living with dementia (PLWD) in the United States. Although this population is growing and highly complex, evidence-based management remains poorly integrated within healthcare systems. Therefore, the National Institute on Aging IMPACT Collaboratory was formed to build the nation's ability to conduct embedded pragmatic clinical trials (ePCTs) for PLWD and their caregivers. The pilot core of the IMPACT Collaboratory seeks to provide funds for upward of 40 pilots for ePCTs to accelerate the testing of nonpharmacologic interventions with the goal that these pilots lead to full-scale ePCTs and eventually the embedding of evidence-based care into healthcare systems. The first two challenges for the pilot core in building the pilot study program were (1) to develop a transparent, ethical, and open nationwide process for soliciting, reviewing, and selecting pilot studies; and (2) to begin the process of describing the necessary components of a pilot study for an ePCT. During our initial funding cycle, we received 35 letters of intent, of which 17 were accepted for a full proposal and 14 were submitted. From this process we learned that investigators lack knowledge in ePCTs, many interventions lack readiness for an ePCT pilot study, and many proposed studies lack key pragmatic design elements. We therefore have set three key criteria that future pilot studies must meet at a minimum to be considered viable. We additionally discuss key design decisions investigators should consider in designing a pilot study for an ePCT. J Am Geriatr Soc 68:S14-S20, 2020.
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http://dx.doi.org/10.1111/jgs.16618DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393801PMC
July 2020

Enrollment in the Zoster Eye Disease Study.

Cornea 2020 Dec;39(12):1480-1484

Department of Population Health, NYU Grossman School of Medicine, New York, NY.

Purpose: To present the results of a survey of the Zoster Eye Disease Study (ZEDS) investigators regarding barriers to the enrollment of study participants and approaches to overcome them.

Methods: ZEDS is a multicenter randomized clinical trial supported by the National Eye Institute to determine whether prolonged suppressive valacyclovir reduces the complications of herpes zoster ophthalmicus (HZO), relative to placebo. Enrollment of study participants is currently far below expectations. An institutional review board-approved anonymous internet survey was conducted of ZEDS investigators to study their experiences and opinions regarding barriers to enrollment and various approaches to overcome them.

Results: The overall survey response rate was 54% (79/145). Only 29% (23/79) agreed that it is easy to enroll study participants. Regarding patient barriers, 69% (55/79) agreed that HZO patients want to be treated with antiviral medication and 69% (54/78) agreed that HZO patients on antivirals do not want to be randomized. Regarding personal barriers facing investigators, 91% (72/79) agreed that antivirals are effective and 100% that the research questions ZEDS is designed to answer are very important. Fewer than 30% of respondents believed that steps taken to increase enrollment have been very helpful. Over half (54%, 42/78) believed that advertising on social media would be moderately or very effective.

Conclusions: Belief among ZEDS investigators that antivirals are effective, and the preference of patients to be treated with antivirals rather than be randomized in ZEDS, are major barriers to enrollment. New approaches to overcoming barriers are necessary to develop an evidence-based standard of care for treatment of HZO.
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http://dx.doi.org/10.1097/ICO.0000000000002392DOI Listing
December 2020

Feasibility and acceptability of an oral pathology asynchronous tele-mentoring intervention: A protocol.

J Public Health Res 2020 Jun 27;9(1):1777. Epub 2020 May 27.

Ronald O. Perelman Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, USA.

Oral cancer remains prevalent, despite being largely preventable. The widespread use of technology at chairside, combined with advances in electronic health record (EHR) capabilities, present opportunities to improve oral cancer screening by dentists, especially for disadvantaged patients with severe health needs. Using a mixed-methods approach, we will evaluate the feasibility and acceptability of integrating a telementoring component into the identification of oral lesions using the following 3 methods: 1) administering provider surveys that consist of a checklist of 10 key components of the intervention based on process, and asking the dental provider subjects if each one was covered; 2) conducting semi-structured interviews informed by the Consolidated Framework for Implementation Research and the Implementation Outcomes Framework with dental resident subjects to assess specific barriers to sustaining the intervention and strategies for addressing these barriers to facilitate integration of the intervention into the routine workflow of the dental clinics; and 3) administering brief exit interviews with patient subjects regarding the acceptability of the intervention to assess satisfaction with the use of intra-oral cameras at chairside to screen for and refer patients with oral lesions and identification of these oral lesions via EHR and secure e-mail tele-mentoring with an oral pathology expert. If successful, then later clinical trials will maximize the external validity of the intervention and facilitate the widespread implementation and dissemination of the model for the teaching of dentists and residents, with the ultimate goal of improving patient care.
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http://dx.doi.org/10.4081/jphr.2020.1777DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7282314PMC
June 2020

Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Covid-19.

N Engl J Med 2020 06 1;382(25):2441-2448. Epub 2020 May 1.

From the New York University (NYU) Grossman School of Medicine, New York.

Background: There is concern about the potential of an increased risk related to medications that act on the renin-angiotensin-aldosterone system in patients exposed to coronavirus disease 2019 (Covid-19), because the viral receptor is angiotensin-converting enzyme 2 (ACE2).

Methods: We assessed the relation between previous treatment with ACE inhibitors, angiotensin-receptor blockers, beta-blockers, calcium-channel blockers, or thiazide diuretics and the likelihood of a positive or negative result on Covid-19 testing as well as the likelihood of severe illness (defined as intensive care, mechanical ventilation, or death) among patients who tested positive. Using Bayesian methods, we compared outcomes in patients who had been treated with these medications and in untreated patients, overall and in those with hypertension, after propensity-score matching for receipt of each medication class. A difference of at least 10 percentage points was prespecified as a substantial difference.

Results: Among 12,594 patients who were tested for Covid-19, a total of 5894 (46.8%) were positive; 1002 of these patients (17.0%) had severe illness. A history of hypertension was present in 4357 patients (34.6%), among whom 2573 (59.1%) had a positive test; 634 of these patients (24.6%) had severe illness. There was no association between any single medication class and an increased likelihood of a positive test. None of the medications examined was associated with a substantial increase in the risk of severe illness among patients who tested positive.

Conclusions: We found no substantial increase in the likelihood of a positive test for Covid-19 or in the risk of severe Covid-19 among patients who tested positive in association with five common classes of antihypertensive medications.
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http://dx.doi.org/10.1056/NEJMoa2008975DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206932PMC
June 2020

Impact of Treatment Beyond Progression with Immune Checkpoint Blockade in Hodgkin Lymphoma.

Oncologist 2020 06 28;25(6):e993-e997. Epub 2020 Apr 28.

Dana Farber Cancer Institute, Boston, Massachusetts, USA.

Atypical response patterns following immune checkpoint blockade (ICB) in Hodgkin lymphoma (HL) led to the concept of continuation of treatment beyond progression (TBP); however, the longitudinal benefit of this approach is unclear. We therefore performed a retrospective analysis of 64 patients treated with ICB; 20 who received TBP (TBP cohort) and 44 who stopped ICB at initial progression (non-TBP cohort). The TBP cohort received ICB for a median of 4.7 months after initial progression and delayed subsequent treatment by a median of 6.6 months. Despite receiving more prior lines of therapy, the TBP cohort achieved longer progression-free survival with post-ICB treatment (median, 17.5 months vs. 6.1 months, p = .035) and longer time-to-subsequent treatment failure, defined as time from initial ICB progression to failure of subsequent treatment (median, 34.6 months vs. 9.9 months, p = .003). With the limitations of a retrospective study, these results support the clinical benefit of TBP with ICB for selected patients.
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http://dx.doi.org/10.1634/theoncologist.2020-0040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288660PMC
June 2020

Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial.

JAMA Netw Open 2020 03 2;3(3):e201742. Epub 2020 Mar 2.

Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.

Importance: There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care.

Objective: To examine whether default options in ADs influence care choices and clinical outcomes.

Design, Setting, And Participants: This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019.

Interventions: Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD).

Main Outcomes And Measures: This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care.

Results: Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes.

Conclusions And Relevance: In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes.

Trial Registration: ClinicalTrials.gov Identifier: NCT02017548.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.1742DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315782PMC
March 2020

Testing patient-informed approaches for visually depicting the hemoglobin A1c value to patients with poorly controlled diabetes: a randomized, controlled trial.

BMC Health Serv Res 2020 Mar 6;20(1):178. Epub 2020 Mar 6.

Division of General Internal Medicine, Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.

Background: Patients' understanding of the hemoglobin A1c (HbA1c) has been linked to better diabetes care outcomes (glycemic control, self-care). This is concerning given low documented rates of HbA1c understanding. In this non-blinded, randomized trial, we compared two formats for communicating the HbA1c, selected based on input from people with diabetes, to standard presentation to assess their impact on participants' glycemic control and diabetes-related perceptions.

Methods: To design the tested formats, we interviewed 25 patients with diabetes and reviewed a range of possible formats, including color-based scales and graphs. The interviews were recorded, transcribed, and subjected to thematic analysis. Synthesizing interviewees' feedback, we selected two formats, one using a combination of words and colors (Words) and one using a color-coded graph (Graph), for further evaluation. We then randomized adults with poorly controlled diabetes to receive mailed information on their current diabetes control in one of three ways: 1) standard lab report (control), 2) Words format, or 3) Graph format. The primary outcome was HbA1c change at 6 months. Also examined were changes in participants' diabetes-related perceptions and choice of participation incentive.

Results: Of the 234 enrolled participants, 76.9% were Black, and their median baseline HbA1c was 9.1% (interquartile range 8.4-10.4). There were no between-arm differences in HbA1c change (- 1.04% [SD 2.2] Control vs. -0.59% [SD 2.0] Words vs. -0.54% [SD 2.1] Graph, p > 0.05 for all comparisons). Participants in the Words arm had an increase in the accuracy of their perceptions of diabetes seriousness (p = 0.04) and in the number of participants reporting a diabetes management goal (p = 0.01).

Conclusions: The two patient-informed communication formats did not differentially impact glycemic control among adults with inadequately controlled diabetes. However, a significant proportion of participants in the Words arm had an increase in the accuracy of their perception of diabetes seriousness, a potential mediating factor in positive diabetes-related behavioral changes. With increasing use of patient-facing online portals, thoughtfully designed approaches for visually communicating essential, but poorly understood, information like the HbA1c to patients have the potential to facilitate interpretation and support self-management.

Clinical Trial Registration: Prospectively registered as NCT01886170.
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http://dx.doi.org/10.1186/s12913-020-5035-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059706PMC
March 2020

Changes in Outpatient Imaging Utilization and Spending Under a New Population-Based Primary Care Payment Model.

J Am Coll Radiol 2020 Jan;17(1 Pt B):101-109

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania. Electronic address:

Objective: To evaluate whether the implementation of a new population-based primary care payment system, Population-Based Payments for Primary Care (3PC), initiated by Hawaii Medical Service Association (HMSA; the Blue Cross Blue Shield of Hawaii), was associated with changes in spending and utilization for outpatient imaging in its first year.

Methods: In this observational study, we used claims data from January 1, 2012, to December 31, 2016. We used a propensity-weighted difference-in-differences design to compare 70,284 HMSA patients in Hawaii attributed to 107 primary care physicians (PCPs) and 4 physician organizations participating in 3PC in its first year of implementation (2016) and 195,902 patients attributed to 312 PCPs and 14 physician organizations that used a fee-for-service model during the study period. The primary outcome was total spending on outpatient imaging tests, and secondary outcomes included spending and utilization by modality.

Results: The study included 266,186 HMSA patients (mean age of 43.3 years; 51.7% women) and 419 PCPs (mean age of 54.9 years; 34.8% women). The 3PC system was not significantly associated with changes in total spending for outpatient imaging. Of 12 secondary outcomes, only 3 were statistically significant, including changes in nuclear medicine spending (adjusted differential change = -20.1% [95% confidence interval = -27.5% to -12.1%]; P < .001) and utilization (adjusted differential change = -18.1% [95% confidence interval = -23.8 to -11.9%]; P < .001).

Discussion: The HMSA 3PC system was not associated with significant changes in total spending for outpatient imaging, though spending and utilization on nuclear medicine tests decreased.
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http://dx.doi.org/10.1016/j.jacr.2019.08.013DOI Listing
January 2020

Effect of Escalating Financial Incentive Rewards on Maintenance of Weight Loss: A Randomized Clinical Trial.

JAMA Netw Open 2019 11 1;2(11):e1914393. Epub 2019 Nov 1.

Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Importance: Identifying effective strategies for treating obesity is a public health priority.

Objective: To test an escalating lottery-based incentive tied to daily self-weighing for weight loss maintenance.

Design, Setting, And Participants: This 2-phase, 2-arm randomized clinical trial enrolled participants aged 30 to 80 years with an initial body mass index (calculated as weight in kilograms divided by height in meters squared) of 30.0 to 45.0 who lost at least 5 kg during 4 to 6 months in a national online weight management program. Study investigators and outcomes assessors were blinded to participant groups. Data were collected and analyzed from May 23, 2016, through November 13, 2017, based on intention to treat.

Interventions: All participants were advised to weigh themselves daily, with a goal of 6 or more days per week, and received text messaging feedback on their performance. Incentive group participants were eligible for a lottery-based incentive worth an expected value of $3.98 in week 1 that escalated by $0.43 each week they achieved their self-weighing goal during months 1 to 6 (phase 1), followed by no incentives during months 7 to 12 (phase 2).

Main Outcomes And Measures: The primary outcome was weight change at the end of phase 1. Secondary outcomes included weight change at the end of phase 2 and changes in self-reported physical activity and eating behaviors.

Results: A total of 258 participants (128 in the incentive group and 130 in the control group) had a mean (SD) age of 48.0 (10.5) years and mean (SD) body mass index of 32.1 (3.9); 225 (87.2%) were women; 235 (91.1%) were white; and 102 (39.5%) had an annual income of at least $100 000. Weight measurement was transmitted by 250 participants (96.9%) at 6 months and 227 (88.0%) at 12 months. The percentage of weeks that incentive and control participants achieved a mean self-weighing of at least 6 times was 85.3% vs 75.8%, respectively (P = .002) in phase 1 and 37.7% vs 50.2%, respectively (P = .009) in phase 2. Mean weight changes at the end of phase 1 were -1.1 (95% CI, -2.1 to -0.1) kg in the incentive group and -1.9 (95% CI, -2.9 to -0.8) kg in the control group, with a mean difference of 0.7 (95% CI, -0.7 to 2.2) kg (P = .30 for comparison). At the end of phase 2, mean weight changes were 0.2 (95% CI, -1.2 to 1.7) kg in the incentive group and -0.6 (95% CI, -2.0 to 0.8) kg in the control group, with a mean difference of 0.8 (95% CI, -1.2 to 2.8) kg (P = .41 for comparison).

Conclusions And Relevance: Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.

Trial Registration: ClinicalTrials.gov identifier: NCT01900392.
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http://dx.doi.org/10.1001/jamanetworkopen.2019.14393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6826643PMC
November 2019

A survey of caregiver acculturation and acceptance of silver diamine fluoride treatment for childhood caries.

BMC Oral Health 2019 10 24;19(1):228. Epub 2019 Oct 24.

NYU Langone Dental Medicine, 5800 Third Avenue, Brooklyn, NY, 11220, USA.

Background: Interest in aqueous silver diamine fluoride (SDF) has been growing as a treatment for caries arrest. A cross-sectional study was conducted to identify factors associated with caregiver acceptance of SDF treatment for children presenting with caries at 8 Federally Qualified Health Centers. The study purpose was to examine associations between caregiver acceptance of SDF treatment for children with caries and (1) sociodemographic and acculturation characteristics of caregivers and (2) clinical assessments of the children by dentists.

Methods: A caregiver survey collected information on: sociodemographic characteristics; acculturation characteristics, measured using the validated Short Acculturation Scale for Hispanics (SASH); perceived benefits and barriers of SDF treatment, including caregiver comfort; and perceived health-related knowledge. Chart reviews were conducted to assess: the medical / dental insurance of pediatric patients; cumulative caries experience, measured using decayed, missing, filled teeth total scores (dmft / DMFT); whether operating room treatment was needed; and a record of caregiver acceptance of SDF treatment (the outcome measure). Standard logistic regression models were developed for caregiver acceptance of SDF treatment for their children as the binary outcome of interest (yes / no) to calculate unadjusted odds ratios (OR) and adjusted ORs for covariates of interest.

Results: Overall, 434 of 546 caregivers (79.5%) accepted SDF treatment for their children. A U-shaped relationship between caregiver odds of accepting SDF treatment and age group of pediatric patients was present, where caregivers were most likely to accept SDF treatment for their children who were either < 6 years or 9-14 years, and least likely to accept SDF treatment for children 6 to < 9 years. The relationship between acculturation and caregiver acceptance of SDF treatment depended upon whether or not caregivers were born in the United States: greater acculturation was associated with caregiver acceptance of SDF treatment among caregivers born in this country, and lower acculturation was associated with caregiver acceptance of SDF treatment among caregivers born elsewhere.

Conclusions: Caregiver acceptance of SDF treatment is high; child's age and caregiver comfort are associated with acceptance. Providers need to communicate the risks and benefits of evidence-based dental treatments to increasingly diverse caregiver and patient populations.
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http://dx.doi.org/10.1186/s12903-019-0915-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814040PMC
October 2019