Faculty Bibliography

OBJECTIVE:To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients. METHODS:We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes. RESULTS:We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics. CONCLUSION/CONCLUSIONS:Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.

Background Self-monitoring of blood pressure (SMBP) improves blood pressure (BP) outcomes at 12-months, but information is lacking on how SMBP affects hypertension care processes and longer-term BP outcomes. Methods and Results We pooled individual participant data from 4 randomized clinical trials of SMBP in the United Kingdom (combined n=2590) with varying intensities of support. Multivariable random effects regression was used to estimate the probability of antihypertensive intensification at 12 months for usual care versus SMBP. Using these data, we simulated 5-year BP control rates using a validated mathematical model. Trial participants were mostly older adults (mean age 66.6 years, SD 9.5), male (53.9%), and predominantly white (95.6%); mean baseline BP was 151.8/85.0 mm Hg. Compared with usual care, the likelihood of antihypertensive intensification increased with both SMBP with feedback to patient or provider alone (odds ratio 1.8, 95% CI 1.2-2.6) and with telemonitoring or self-management (3.3, 2.5-4.2). Over 5 years, we estimated 33.4% BP control (<140/90 mm Hg) with usual care (95% uncertainty interval 27.7%-39.4%). One year of SMBP with feedback to patient or provider alone achieved 33.9% (28.3%-40.3%) BP control and SMBP with telemonitoring or self-management 39.0% (33.1%-45.2%) over 5 years. If SMBP interventions and associated BP control processes were extended to 5 years, BP control increased to 52.4% (45.4%-59.8 %) and 72.1% (66.5%-77.6%), respectively. Conclusions One year of SMBP plus telemonitoring or self-management increases the likelihood of antihypertensive intensification and could improve BP control rates at 5 years; continuing SMBP for 5 years could further improve BP control.

BACKGROUND:The development of mobile health (mHealth) technologies is progressing at a faster pace than that of the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors (ICMJE) guidelines, clinical trials that prospectively assign people to interventions should be registered with a database before the initiation of the study. OBJECTIVE:The aim of this study was to better understand the smartphone mHealth trials for high-burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018, including the number, types, and characteristics of the studies being conducted; the frequency and timing of any outcome changes; and the reporting of results. METHODS:We conducted a systematic search of ClinicalTrials.gov for the top 10 most disabling neuropsychiatric conditions and prespecified terms related to mHealth. According to the 2016 World Health Organization Global Burden of Disease Study, the top 10 most disabling neuropsychiatric conditions are (1) stroke, (2) migraine, (3) major depressive disorder, (4) Alzheimer disease and other dementias, (5) anxiety disorders, (6) alcohol use disorders, (7) opioid use disorders, (8) epilepsy, (9) schizophrenia, and (10) other mental and substance use disorders. There were no date, location, or status restrictions. RESULTS:Our search identified 135 studies. A total of 28.9% (39/135) of studies evaluated interventions for major depressive disorder, 14.1% (19/135) of studies evaluated interventions for alcohol use disorders, 12.6% (17/135) of studies evaluated interventions for stroke, 11.1% (15/135) of studies evaluated interventions for schizophrenia, 8.1% (11/135) of studies evaluated interventions for anxiety disorders, 8.1% (11/135) of studies evaluated interventions for other mental and substance use disorders, 7.4% (10/135) of studies evaluated interventions for opioid use disorders, 3.7% (5/135) of studies evaluated interventions for Alzheimer disease or other dementias, 3.0% (4/135) of studies evaluated interventions for epilepsy, and 3.0% (4/135) of studies evaluated interventions for migraine. The studies were first registered in 2008; more than half of the studies were registered from 2016 to 2018. A total of 18.5% (25/135) of trials had results reported in some publicly accessible location. Across all the studies, the mean estimated enrollment (reported by the study) was 1078, although the median was only 100. In addition, across all the studies, the actual reported enrollment was lower, with a mean of 249 and a median of 80. Only about a quarter of the studies (35/135, 25.9%) were funded by the National Institutes of Health. CONCLUSIONS:Despite the increasing use of health-based technologies, this analysis of ClinicalTrials.gov suggests that only a few apps for high-burden neuropsychiatric conditions are being clinically evaluated in trials.

BACKGROUND:Telehealth-delivered pulmonary rehabilitation (telePR) has been shown to be as effective as standard pulmonary rehabilitation (PR) at improving the quality of life in patients living with chronic obstructive pulmonary disease (COPD). However, it is not known how effective telePR may prove to be among low-income, urban Hispanic American and African American patient populations. To address this question, a collaborative team at Northwell Health developed a telePR intervention and assessed its efficacy among low-income Hispanic American and African American patient populations. The telePR intervention system components included an ergonomic recumbent bike, a tablet with a built-in camera, and wireless monitoring devices. OBJECTIVE:The objective of the study was to assess patient adoption and diminish barriers to use by initiating a user-centered design approach, which included usability testing to refine the telePR intervention prior to enrolling patients with COPD into a larger telePR study. METHODS:Usability testing was conducted in two phases to identify opportunities to streamline and improve the patient experience. The first phase included a prefield usability testing phase to evaluate technical, patient safety, and environmental factors comprising the system architecture. This was followed by an ergonomic evaluation of user interactions with the bicycle, telehealth tablets, and connected wearable devices to ensure optimal placement and practical support for all components of the intervention. The second phase of research included feasibility testing to observe and further optimize the system based on iterative rounds of telePR sessions. RESULTS:During usability and feasibility research, we identified and addressed multiple opportunities for system improvements. These included physical and environmental changes, modifications to accommodate individual patient factors, safety improvements, and technology upgrades. Each enrolled patient was subsequently identified and classified into one of the following 3 categories: (1) independent, (2) intermediate, or (3) dependent. This categorization was used to predict the level of training and support needed for successful participation in the telePR sessions. Feasibility results revealed that patients in the dependent category were unable to perform the rehab sessions without in-person support due to low technical acumen and difficulty with certain features of the system, even after modifications had been made. Intermediate and independent users, however, did exhibit increased independent utilization of telePR due to iterative improvements. CONCLUSIONS:Usability testing helped reduce barriers to use for two subsets of our population, the intermediate and independent users. In addition, it identified a third subset, dependent users, for whom the telePR solution was deemed unsuitable without in-person support. The study established the need for the development of standard operating procedures, and guides were created for both patients and remote respiratory therapists to facilitate the appropriate use of the telePR system intervention. Observational research also led to the development of standard protocols for the first and all subsequent telePR sessions. The primary goals in developing standardization protocols were to establish trust, ensure a positive experience, and encourage future patient engagement with telePR sessions.

BACKGROUND:Older lesbian, gay, and bisexual (LGB) adults are an underserved and understudied population that experience specific health disparities. The intersection of aging and chronic medical disease with a higher risk for substance use and mental illness may place older LGB adults at risk for co-occurring conditions and resulting comorbidity. Understanding multimorbidity among older LGB adults may help inform interventions to reduce disparities in health outcomes. METHODS:Data come from the 2015 to 2017 National Surveys on Drug Use and Health (n = 25,880). We first determined whether sexual orientation was associated with reporting: past-year drug use, mental illness, and/or 2 or more chronic medical diseases. We then determined whether sexual orientation was associated with reporting co-occurrence of these conditions. This was done using multivariable logistic regression. Analyses were stratified by gender. RESULTS:Compared to heterosexual men, gay men were at increased odds for reporting 2 or more chronic medical diseases (adjusted odds ratio [aOR] = 2.18, 95% confidence interval [CI] = 1.48, 3.21), and gay (aOR = 1.79, 95% CI = 1.09, 2.93) and bisexual men (aOR = 3.53, 95% CI = 2.03, 6.14) were at increased odds for reporting mental illness. Gay men (aOR = 2.95, 95CI = 1.60, 5.49) and bisexual men (aOR = 2.84, 95% CI = 1.58, 5.08) were at increased odds of reporting co-occurring conditions. Compared to heterosexual women, bisexual women were at increased odds for past-year drug use (aOR = 4.20, 95% CI = 2.55, 6.93), reporting mental illness (aOR = 1.94, 95% CI = 1.03, 3.67), and reporting co-occurring conditions (aOR = 3.25, 95% = 1.60, 6.62). CONCLUSIONS:Middle-aged and older LGB adults in the United States are at high risk for experiencing co-occurring drug use, mental illness, and/or medical multimorbidity. Interventions for older sexual minority populations are needed to reduce disparities.

Importance:Predialysis nephrology care is associated with better survival among patients with end-stage kidney disease. Objective:To examine national trends in racial/ethnic disparities in receipt of predialysis nephrology care at least 1 year before dialysis initiation in the United States from 2005 to 2015. Design, Setting, and Participants:This national registry study assessed US registry data of 1 000 390 adults in the US Renal Data System who initiated maintenance dialysis treatment from January 1, 2005, to December 31, 2015, in multiple cross-sectional analyses. Multivariable logistic regression models were used to examine national trends in racial/ethnic disparities in receipt of predialysis nephrology care with adjustments for potential confounders. Data were analyzed April 17, 2020. Exposure:Race/ethnicity of the patients. Main Outcomes and Measures:Receipt of at least 12 months of predialysis nephrology care as determined by clinician-based documentation on the End Stage Renal Disease Medical Evidence Report Form CMS 2728. Results:Among 1 000 390 adults (57.2% male; 54.6% White, 27.8% Black, 14.0% Hispanic, and 3.6% Asian; mean [SD] age, 62.4 [15.6] years) who initiated maintenance dialysis in the United States from 2005 to 2015, 310 743 (31.1%) received at least 12 months of predialysis nephrology care. In 2005 to 2007, compared with White adults, the adjusted odds ratio for receipt of at least 12 months of predialysis nephrology care was 0.82 (95% CI, 0.80-0.84) among Black adults, 0.67 (95% CI, 0.65-0.69) among Hispanic adults, and 0.84 (95% CI, 0.80-0.89) among Asian adults; in 2014 to 2015, the adjusted odds ratio was 0.76 (95% CI, 0.74-0.78) among Black adults, 0.61 (95% CI, 0.60-0.63) among Hispanic adults, and 0.90 (95% CI: 0.86-0.95) among Asian adults. Conclusions and Relevance:In this cross-sectional study of more than 1 million US adults with end-stage kidney disease, racial and ethnic disparities in predialysis nephrology care did not substantially improve from 2005 to 2015. Study findings suggest that national strategies to address racial/ethnic disparities in predialysis nephrology care are needed.

Importance/UNASSIGNED:Bisphenol A (BPA) is a major public health concern because of its high-volume industrial production, ubiquitous exposure to humans, and potential toxic effects on multiple organs and systems in humans. However, prospective studies regarding the association of BPA exposure with long-term health outcomes are sparse. Objective/UNASSIGNED:To examine the association of BPA exposure with all-cause mortality and cause-specific mortality among adults in the United States. Design, Setting, and Participants/UNASSIGNED:This nationally representative cohort study included 3883 adults aged 20 years or older who participated in the US National Health and Nutrition Examination Survey 2003-2008 and provided urine samples for BPA level measurements. Participants were linked to mortality data from survey date through December 31, 2015. Data analyses were conducted in July 2019. Exposures/UNASSIGNED:Urinary BPA levels were quantified using online solid-phase extraction coupled to high-performance liquid chromatography-isotope dilution tandem mass spectrometry. Main Outcomes and Measures/UNASSIGNED:Mortality from all causes, cardiovascular disease, and cancer. Results/UNASSIGNED:This cohort study included 3883 adults aged 20 years or older (weighted mean [SE] age, 43.6 [0.3] years; 2032 women [weighted, 51.4%]). During 36 514 person-years of follow-up (median, 9.6 years; maximum, 13.1 years), 344 deaths occurred, including 71 deaths from cardiovascular disease and 75 deaths from cancer. Participants with higher urinary BPA levels were at higher risk for death. After adjustment for age, sex, race/ethnicity, socioeconomic status, dietary and lifestyle factors, body mass index, and urinary creatinine levels, the hazard ratio comparing the highest vs lowest tertile of urinary BPA levels was 1.49 (95% CI, 1.01-2.19) for all-cause mortality, 1.46 (95% CI, 0.67-3.15) for cardiovascular disease mortality, and 0.98 (95% CI, 0.40-2.39) for cancer mortality. Conclusions and Relevance/UNASSIGNED:In this nationally representative cohort of US adults, higher BPA exposure was significantly associated with an increased risk of all-cause mortality. Further studies are needed to replicate these findings in other populations and determine the underlying mechanisms.

There is currently no criterion to select appropriate bioinformatics tools and reference databases for analysis of 16S rRNA amplicon data in the human oral microbiome. Our study aims to determine the influence of multiple tools and reference databases on α-diversity measurements and β-diversity comparisons analyzing the human oral microbiome. We compared the results of taxonomical classification by Greengenes, the Human Oral Microbiome Database (HOMD), National Center for Biotechnology Information (NCBI) 16S, SILVA, and the Ribosomal Database Project (RDP) using Quantitative Insights Into Microbial Ecology (QIIME) and the Divisive Amplicon Denoising Algorithm (DADA2). There were 15 phyla present in all of the analyses, four phyla exclusive to certain databases, and different numbers of genera were identified in each database. Common genera found in the oral microbiome, such as Veillonella, Rothia, and Prevotella, are annotated by all databases; however, less common genera, such as Bulleidia and Paludibacter, are only annotated by large databases, such as Greengenes. Our results indicate that using different reference databases in 16S rRNA amplicon data analysis could lead to different taxonomic compositions, especially at genus level. There are a variety of databases available, but there are no defined criteria for data curation and validation of annotations, which can affect the accuracy and reproducibility of results, making it difficult to compare data across studies.

Importance/UNASSIGNED:An important consequence of cannabis legalization is the potential increase in the number of cannabis-impaired drivers on roads, which may result in higher rates of traffic-related injuries and fatalities. To date, limited information about the effects of recreational cannabis laws (RCLs) on traffic fatalities is available. Objective/UNASSIGNED:To estimate the extent to which the implementation of RCLs is associated with traffic fatalities in Colorado and Washington State. Design, Setting, and Participants/UNASSIGNED:This ecological study used a synthetic control approach to examine the association between RCLs and changes in traffic fatalities in Colorado and Washington State in the post-RCL period (2014-2017). Traffic fatalities data were obtained from the Fatality Analysis Reporting System from January 1, 2005, to December 31, 2017. Data from Colorado and Washington State were compared with synthetic controls. Data were analyzed from January 1, 2005, to December 31, 2017. Main Outcome(s) and Measures/UNASSIGNED:The primary outcome was the rate of traffic fatalities. Sensitivity analyses were performed (1) excluding neighboring states, (2) excluding states without medical cannabis laws (MCLs), and (3) using the enactment date of RCLs to define pre-RCL and post-RCL periods instead of the effective date. Results/UNASSIGNED:Implementation of RCLs was associated with increases in traffic fatalities in Colorado but not in Washington State. The difference between Colorado and its synthetic control in the post-RCL period was 1.46 deaths per 1 billion vehicle miles traveled (VMT) per year (an estimated equivalent of 75 excess fatalities per year; probability = 0.047). The difference between Washington State and its synthetic control was 0.08 deaths per 1 billion VMT per year (probability = 0.674). Results were robust in most sensitivity analyses. The difference between Colorado and synthetic Colorado was 1.84 fatalities per 1 billion VMT per year (94 excess deaths per year; probability = 0.055) after excluding neighboring states and 2.16 fatalities per 1 billion VMT per year (111 excess deaths per year; probability = 0.063) after excluding states without MCLs. The effect was smaller when using the enactment date (24 excess deaths per year; probability = 0.116). Conclusions and Relevance/UNASSIGNED:This study found evidence of an increase in traffic fatalities after the implementation of RCLs in Colorado but not in Washington State. Differences in how RCLs were implemented (eg, density of recreational cannabis stores), out-of-state cannabis tourism, and local factors may explain the different results. These findings highlight the importance of RCLs as a factor that may increase traffic fatalities and call for the identification of policies and enforcement strategies that can help prevent unintended consequences of cannabis legalization.