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Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness

Schneider, Aaron H; Bair, Matthew J; Helmer, Drew A; Hyde, Justeen; Litke, David; Lu, Shou-En; Rogers, Erin S; Sherman, Scott E; Sotolongo, Anays; Anastasides, Nicole; Sullivan, Nicole; Graff, Fiona; McAndrew, Lisa M
AIMS/OBJECTIVE:We describe a clinical trial which is seeking to determine the effectiveness and understand implementation outcomes for tele-collaborative specialty care for Veterans with Gulf War Illness (GWI). MAIN METHODS/METHODS:This study will be a hybrid type 1 randomized effectiveness-implementation trial comparing tele-collaborative specialty care to electronic consultation for Gulf War Veterans with GWI (N = 220). In tele-collaborative specialty care, the specialty provider team will deliver health coaching and problem-solving treatment to Veterans and recommend a plan for analgesic optimization. In electronic consultation, the specialty provider team will make a one-time recommendation to the primary care team for locally delivered health coaching, problem-solving treatment and analgesic optimization. The primary aim will be to determine the effectiveness of tele-collaborative specialty care as compared to electronic consultation to reduce disability related to GWI. Our secondary aim will be to understand implementation outcomes. SIGNIFICANCE/CONCLUSIONS:There is a need to improve care for Veterans with GWI. A potentially useful model to improve care is tele-collaborative specialty care, where the specialists work with the primary care provider to synergistically treat the patients. DISCUSSION/CONCLUSIONS:This is the first clinical trial to prospectively compare different models of care for Veterans with GWI. This responds to multiple calls for research to improve treatment for Veterans with GWI, including from the National Academy of Medicine.
PMID: 34599935
ISSN: 1879-0631
CID: 5147092

Pediatric Trainee Perspectives on the Decision to Disclose Medical Errors

Lin, Matthew; Horwitz, Leora; Gross, Rachel S; Famiglietti, Hannah; Caplan, Arthur
PURPOSE:The aim of the study was to describe factors that may impact pediatric trainees' willingness to disclose medical errors using clinical vignettes. METHODS:A single-center cross-sectional anonymous survey of pediatric residents and fellows at a large urban medical center in 2019 was conducted. Trainees were provided with clinical vignettes depicting an error resulting in a serious safety event (SSE), minor safety event (MSE), and near miss safety event (NMSE) and were asked to classify the type of safety event and rate and explain their agreement or disagreement with disclosure. Survey items also evaluated trainees' personal experiences with errors and disclosure. Descriptive and correlational analyses were used to characterize responses. Qualitative content from open-ended survey questions was analyzed using the constant comparative method. RESULTS:Of 126 trainees, 42 (33%) completed the survey. All agreed with disclosing the hypothetical error presented in the vignette resulting in an SSE (100%), with rates falling for the MSE (95%) and NMSE (7%). There were no significant associations between disclosure agreement for the vignettes and trainee demographic features, knowledge of safety events, prior personal experiences with errors, and disclosure. Four themes that emerged from qualitative analysis of trainees' rationales for disclosure or nondisclosure of the vignette errors are harm, parental preferences, ethical principles, and anticipatory guidance. CONCLUSIONS:Trainees had high rates of disclosure for the vignette errors cases that depicted SSEs and MSEs but lower rates for NMSEs. Trainees considered the type and level of harm caused, parental preferences, upholding ethical principles, and the need for anticipatory guidance in their rationales for disclosure or nondisclosure of the vignette errors.
PMID: 35188936
ISSN: 1549-8425
CID: 5175012

Association of Ischemic Stroke Incidence, Severity, and Recurrence With Dementia in the Atherosclerosis Risk in Communities Cohort Study

Koton, Silvia; Pike, James Russell; Johansen, Michelle; Knopman, David S; Lakshminarayan, Kamakshi; Mosley, Thomas; Patole, Shalom; Rosamond, Wayne D; Schneider, Andrea L C; Sharrett, A Richey; Wruck, Lisa; Coresh, Josef; Gottesman, Rebecca F
IMPORTANCE/OBJECTIVE:Ischemic stroke is associated with increased risk of dementia, but the association of stroke severity and recurrence with risk of impaired cognition is not well known. OBJECTIVE:To examine the risk of dementia after incident ischemic stroke and assess how it differed by stroke severity and recurrence. DESIGN, SETTING, AND PARTICIPANTS/METHODS:The Atherosclerosis Risk in Communities (ARIC) study is an ongoing prospective cohort of 15 792 community-dwelling individuals from 4 US states (Mississippi, Maryland, Minnesota, and North Carolina). Among them, 15 379 participants free of stroke and dementia at baseline (1987 to 1989) were monitored through 2019. Data were analyzed from April to October 2021. Associations between dementia and time-varying ischemic stroke incidence, frequency, and severity were studied across an average of 4.4 visits over a median follow-up of 25.5 years with Cox proportional hazards models adjusted for sociodemographic characteristics, apolipoprotein E, and vascular risk factors. EXPOSURES/METHODS:Incident and recurrent ischemic strokes were classified by expert review of hospital records, with severity defined by the National Institutes of Health Stroke Scale (NIHSS; minor, ≤5; mild, 6-10; moderate, 11-15; and severe, ≥16). MAIN OUTCOMES AND MEASURES/METHODS:Dementia cases adjudicated through expert review of in-person evaluations, informant interviews, telephone assessments, hospitalization codes, and death certificates. In participants with stroke, dementia events in the first year after stroke were not counted. RESULTS:At baseline, the mean (SD) age of participants was 54.1 (5.8) years, and 8485 of 15 379 participants (55.2%) were women. A total of 4110 participants (26.7%) were Black and 11 269 (73.3%) were White. A total of 1378 ischemic strokes (1155 incident) and 2860 dementia cases were diagnosed 1 year or more after incident stroke in participants with stroke, or at any point after baseline in participants without stroke, were identified through December 31, 2019. NIHSS scores were available for 1184 of 1378 ischemic strokes (85.9%). Risk of dementia increased with both the number and severity of strokes. Compared with no stroke, risk of dementia by adjusted hazard ratio was 1.76 (95% CI, 1.49-2.00) for 1 minor to mild stroke, 3.47 (95% CI, 2.23-5.40) for 1 moderate to severe stroke, 3.48 (95% CI, 2.54-4.76) for 2 or more minor to mild strokes, and 6.68 (95% CI, 3.77-11.83) for 2 or more moderate to severe strokes. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:In this study, risk of dementia significantly increased after ischemic stroke, independent of vascular risk factors. Results suggest a dose-response association of stroke severity and recurrence with risk of dementia.
PMCID:8787684
PMID: 35072712
ISSN: 2168-6157
CID: 5586362

Panel Reactive Antibody and the Association of Early Steroid Withdrawal with Kidney Transplant Outcomes

Bae, Sunjae; McAdams-DeMarco, Mara A; Massie, Allan B; Garonzik-Wang, Jacqueline M; Coresh, Josef; Segev, Dorry L
BACKGROUND:Early steroid withdrawal (ESW) is a viable maintenance immunosuppression strategy in low-risk kidney transplant recipients. A low panel reactive antibody (PRA) may indicate low-risk condition amenable to ESW. We aimed to identify the threshold value of PRA above which ESW may pose additional risk, and to compare the association of ESW with transplant outcomes across PRA strata. METHODS:We studied 121,699 deceased-donor kidney-only recipients in 2002-2017 from SRTR. Using natural splines and ESW-PRA interaction terms, we explored how the associations of ESW with transplant outcomes change with increasing PRA values, and identified a threshold value for PRA. Then, we assessed whether PRA exceeding the threshold modified the associations of ESW with 1-year acute rejection, death-censored graft failure, and death. RESULTS:The association of ESW with acute rejection exacerbated rapidly when PRA exceeded 60. Among PRA≤60 recipients, ESW was associated with a minor increase in rejection (aOR=1.001.051.10) and with a tendency of decreased graft failure (aHR=0.910.971.03). However, among PRA>60 recipients, ESW was associated with a substantial increase in rejection (aOR=1.191.271.36; interaction p<0.001) and with a tendency of increased graft failure (aHR=0.981.081.20; interaction p=0.028). The association of ESW with death was similar between PRA strata (PRA≤60, aHR=0.910.961.01; and PRA>60, aHR=0.900.991.09; interaction p=0.5). CONCLUSIONS:Our findings show that the association of ESW with transplant outcomes is less favorable in recipients with higher PRA, especially those with PRA>60, suggesting a possible role of PRA in the risk assessment for ESW.
PMCID:8490476
PMID: 33826598
ISSN: 1534-6080
CID: 5127092

Mortality Among People Experiencing Homelessness in San Francisco During the COVID-19 Pandemic

Cawley, Caroline; Kanzaria, Hemal K; Zevin, Barry; Doran, Kelly M; Kushel, Margot; Raven, Maria C
Importance:There has been recent media attention on the risk of excess mortality among homeless individuals during the COVID-19 pandemic, yet data on these deaths are limited. Objectives:To quantify and describe deaths among people experiencing homelessness in San Francisco during the COVID-19 pandemic and to compare the characteristics of these deaths with those in prior years. Design, Setting, and Participants:A cross-sectional study tracking mortality among people experiencing homelessness from 2016 to 2021 in San Francisco, California. All deceased individuals who were homeless in San Francisco at the time of death and whose deaths were processed by the San Francisco Office of the Chief Medical Examiner were included. Data analysis was performed from August to October 2021. Exposure:Homelessness, based on homeless living status in an administrative database. Main Outcomes and Measures:Descriptive statistics were used to understand annual trends in demographic characteristics, cause and manner of death (based on autopsy), substances present in toxicology reports, geographic distribution of deaths, and use of health and social services prior to death. Total estimated numbers of people experiencing homelessness in San Francisco were assessed through semiannual point-in-time counts. The 2021 point-in-time count was postponed owing to the COVID-19 pandemic. Results:In San Francisco, there were 331 deaths among people experiencing homelessness in the first year of the COVID-19 pandemic (from March 17, 2020, to March 16, 2021). This number was more than double any number in previous years (eg, 128 deaths in 2016, 128 deaths in 2017, 135 deaths in 2018, and 147 deaths in 2019). Most individuals who died were male (268 of 331 [81%]). Acute drug toxicity was the most common cause of death in each year, followed by traumatic injury. COVID-19 was not listed as the primary cause of any deaths. The proportion of deaths involving fentanyl increased each year (present in 52% of toxicology reports in 2019 and 68% during the pandemic). Fewer decedents had contacts with health services in the year prior to their death during the pandemic than in prior years (13% used substance use disorder services compared with 20% in 2019). Conclusions and Relevance:In this cross-sectional study, the number of deaths among people experiencing homelessness in San Francisco increased markedly during the first year of the COVID-19 pandemic. These findings may guide future interventions to reduce mortality among individuals experiencing homelessness.
PMID: 35267030
ISSN: 2574-3805
CID: 5182312

Publisher Correction: Impact of COVID-19 forecast visualizations on pandemic risk perceptions

Padilla, Lace; Hosseinpour, Helia; Fygenson, Racquel; Howell, Jennifer; Chunara, Rumi; Bertini, Enrico
PMID: 35233074
ISSN: 2045-2322
CID: 5495342

Exploration of Rapid Automatized Naming and Standard Visual Tests in Prodromal Alzheimer Disease Detection

Wu, Shirley Z; Nolan-Kenney, Rachel; Moehringer, Nicholas J; Hasanaj, Lisena F; Joseph, Binu M; Clayton, Ashley M; Rucker, Janet C; Galetta, Steven L; Wisniewski, Thomas M; Masurkar, Arjun V; Balcer, Laura J
BACKGROUND:Visual tests in Alzheimer disease (AD) have been examined over the last several decades to identify a sensitive and noninvasive marker of the disease. Rapid automatized naming (RAN) tasks have shown promise for detecting prodromal AD or mild cognitive impairment (MCI). The purpose of this investigation was to determine the capacity for new rapid image and number naming tests and other measures of visual pathway structure and function to distinguish individuals with MCI due to AD from those with normal aging and cognition. The relation of these tests to vision-specific quality of life scores was also examined in this pilot study. METHODS:Participants with MCI due to AD and controls from well-characterized NYU research and clinical cohorts performed high and low-contrast letter acuity (LCLA) testing, as well as RAN using the Mobile Universal Lexicon Evaluation System (MULES) and Staggered Uneven Number test, and vision-specific quality of life scales, including the 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and 10-Item Neuro-Ophthalmic Supplement. Individuals also underwent optical coherence tomography scans to assess peripapillary retinal nerve fiber layer and ganglion cell/inner plexiform layer thicknesses. Hippocampal atrophy on brain MRI was also determined from the participants' Alzheimer disease research center or clinical data. RESULTS:Participants with MCI (n = 14) had worse binocular LCLA at 1.25% contrast compared with controls (P = 0.009) and longer (worse) MULES test times (P = 0.006) with more errors in naming images (P = 0.009) compared with controls (n = 16). These were the only significantly different visual tests between groups. MULES test times (area under the receiver operating characteristic curve [AUC] = 0.79), MULES errors (AUC = 0.78), and binocular 1.25% LCLA (AUC = 0.78) showed good diagnostic accuracy for distinguishing MCI from controls. A combination of the MULES score and 1.25% LCLA demonstrated the greatest capacity to distinguish (AUC = 0.87). These visual measures were better predictors of MCI vs control status than the presence of hippocampal atrophy on brain MRI in this cohort. A greater number of MULES test errors (rs = -0.50, P = 0.005) and worse 1.25% LCLA scores (rs = 0.39, P = 0.03) were associated with lower (worse) NEI-VFQ-25 scores. CONCLUSIONS:Rapid image naming (MULES) and LCLA are able to distinguish MCI due to AD from normal aging and reflect vision-specific quality of life. Larger studies will determine how these easily administered tests may identify patients at risk for AD and serve as measures in disease-modifying therapy clinical trials.
PMID: 34029274
ISSN: 1536-5166
CID: 4878882

Standards for Objectivity and Reproducibility in High-Impact Developmental Studies-The COVID-19 Pandemic and Beyond

Thomason, Moriah E
PMID: 34901996
ISSN: 2168-6211
CID: 5109622

The Effect of Abuse and Mistreatment on Healthcare Providers (TEAM): A Survey Assessing the Prevalence of Aggression From Patients and Their Families and Its Impact

Pinkhasov, Aaron; Filangieri, Carole; Rzeszut, Mary; Wilkenfeld, Marc; Akerman, Meredith; Divers, Jasmin; Oliveras, Jessica; Bostwick, J Michael; Svoronos, Alexander; Peltier, Morgan R
OBJECTIVE:Aggression from patients and families on health care providers (HCP) is common yet understudied. We measured its prevalence and impact on HCPs in inpatient and outpatient settings. METHODS:Four thousand six hundred seven HCPs employed by a community teaching hospital received an anonymous survey with results analyzed. RESULTS:Of 1609 HCPs (35%) completing the survey, 88% of inpatient staff reported experiencing different types of aggression compared to 82% in outpatient setting. Almost half did not report it to their supervisor. Younger staff were more likely to report abuse. Negative impacts on productivity and patient care were reported. A third of all responders' indicated negative effects on mental health. CONCLUSIONS:Despite negative impacts on staff wellbeing and productivity, patient/family aggression toward HCPs is highly prevalent and underreported. Our healthcare system needs measures to address staff security and wellness.
PMID: 34935679
ISSN: 1536-5948
CID: 5203382

Morbidity and Mortality Caused by Noncompliance With California Hospital Licensure: Immediate Jeopardies in California Hospitals, 2007-2017

Zheng, Micha Y; Lui, Hansen; Patino, German; Mmonu, Nnenaya; Cohen, Andrew J; Breyer, Benjamin N
OBJECTIVE:The California Department of Public Health investigates compliance with hospital licensure and issues an administrative penalty when there is an immediate jeopardy. Immediate jeopardies are situations in which a hospital's noncompliance of licensure requirements causes serious injury or death to patient. In this study, we critically examine immediate jeopardies between 2007 and 2017 in California. METHODS:All immediate jeopardies reported between 2007 and 2017 were abstracted for hospital, location, date, details of noncompliance, and patient's health outcome. RESULTS:Of 385 unique immediate jeopardies, 141 (36.6%) caused mortality, 120 (31.2%) caused morbidity, 96 (24.9%) led to a second surgery, 9 (2.3%) caused emotional trauma without physical trauma, and 19 (4.9%) were caught before patients were harmed. Immediate jeopardy categories included the following: surgical (34.2%), medication (18.9%), monitoring (14.2%), falls (7.8%), equipment (5.4%), procedural (5.4%), resuscitation (4.4%), suicide (3.9%), MD/RN miscommunication (3.4%), and abuse (2.3%). CONCLUSIONS:Noncompliance to hospital licensure causes significant morbidity and mortality. Statewide hospital licensure policies should focus on enacting standardized reporting requirements of immediate jeopardies into an Internet-based form that public health officials can regularly analyze to improve hospital safety.
PMID: 35188929
ISSN: 1549-8425
CID: 5172002