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The "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) Core Outcome Set: International Consensus on Outcomes to Measure in Efficacy and Effectiveness Trials of Alcohol Brief Interventions

Shorter, Gillian W; Bray, Jeremy W; Heather, Nick; Berman, Anne H; Giles, Emma L; Clarke, Mike; Barbosa, Carolina; O'Donnell, Amy J; Holloway, Aisha; Riper, Heleen; Daeppen, Jean-Bernard; Monteiro, Maristela G; Saitz, Richard; McNeely, Jennifer; McKnight-Eily, Lela; Cowell, Alex; Toner, Paul; Newbury-Birch, Dorothy
OBJECTIVE:The purpose of this study was to report the "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) recommended core outcome set (COS) to improve efficacy and effectiveness trials/evaluations for alcohol brief interventions (ABIs). METHOD:A systematic review identified 2,641 outcomes in 401 ABI articles measured by 1,560 different approaches. These outcomes were classified into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This process prioritized 15 of 93 outcome categories for discussion at a consensus meeting of key stakeholders to decide the COS. A psychometric evaluation determined how to measure the outcomes. RESULTS:Ten outcomes were voted into the COS at the consensus meeting: (a) typical frequency, (b) typical quantity, (c) frequency of heavy episodic drinking, (d) combined consumption measure summarizing alcohol use, (e) hazardous or harmful drinking (average consumption), (f) standard drinks consumed in the past week (recent, current consumption), (g) alcohol-related consequences, (h) alcohol-related injury, (i) use of emergency health care services (impact of alcohol use), and (j) quality of life. CONCLUSIONS:The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve the synthesis of new findings, reduce redundant/selective reporting (i.e., reporting only some, usually significant outcomes), improve between-study comparisons, and enhance the relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other, additional outcomes.
PMID: 34546911
ISSN: 1938-4114
CID: 5061452

Pre-deployment risk factors for PTSD in active-duty personnel deployed to Afghanistan: a machine-learning approach for analyzing multivariate predictors

Schultebraucks, Katharina; Qian, Meng; Abu-Amara, Duna; Dean, Kelsey; Laska, Eugene; Siegel, Carole; Gautam, Aarti; Guffanti, Guia; Hammamieh, Rasha; Misganaw, Burook; Mellon, Synthia H; Wolkowitz, Owen M; Blessing, Esther M; Etkin, Amit; Ressler, Kerry J; Doyle, Francis J; Jett, Marti; Marmar, Charles R
Active-duty Army personnel can be exposed to traumatic warzone events and are at increased risk for developing post-traumatic stress disorder (PTSD) compared with the general population. PTSD is associated with high individual and societal costs, but identification of predictive markers to determine deployment readiness and risk mitigation strategies is not well understood. This prospective longitudinal naturalistic cohort study-the Fort Campbell Cohort study-examined the value of using a large multidimensional dataset collected from soldiers prior to deployment to Afghanistan for predicting post-deployment PTSD status. The dataset consisted of polygenic, epigenetic, metabolomic, endocrine, inflammatory and routine clinical lab markers, computerized neurocognitive testing, and symptom self-reports. The analysis was computed on active-duty Army personnel (N = 473) of the 101st Airborne at Fort Campbell, Kentucky. Machine-learning models predicted provisional PTSD diagnosis 90-180 days post deployment (random forest: AUC = 0.78, 95% CI = 0.67-0.89, sensitivity = 0.78, specificity = 0.71; SVM: AUC = 0.88, 95% CI = 0.78-0.98, sensitivity = 0.89, specificity = 0.79) and longitudinal PTSD symptom trajectories identified with latent growth mixture modeling (random forest: AUC = 0.85, 95% CI = 0.75-0.96, sensitivity = 0.88, specificity = 0.69; SVM: AUC = 0.87, 95% CI = 0.79-0.96, sensitivity = 0.80, specificity = 0.85). Among the highest-ranked predictive features were pre-deployment sleep quality, anxiety, depression, sustained attention, and cognitive flexibility. Blood-based biomarkers including metabolites, epigenomic, immune, inflammatory, and liver function markers complemented the most important predictors. The clinical prediction of post-deployment symptom trajectories and provisional PTSD diagnosis based on pre-deployment data achieved high discriminatory power. The predictive models may be used to determine deployment readiness and to determine novel pre-deployment interventions to mitigate the risk for deployment-related PTSD.
PMID: 32488126
ISSN: 1476-5578
CID: 4469032

Social and Economic Differences in Neighborhood Walkability Across 500 U.S. Cities

Conderino, Sarah E; Feldman, Justin M; Spoer, Benjamin; Gourevitch, Marc N; Thorpe, Lorna E
INTRODUCTION/BACKGROUND:Neighborhood walkability has been established as a potentially important determinant of various health outcomes that are distributed inequitably by race/ethnicity and sociodemographic status. The objective of this study is to assess the differences in walkability across major urban centers in the U.S. METHODS:City- and census tract-level differences in walkability were assessed in 2020 using the 2019 Walk Score across 500 large cities in the U.S. RESULTS:At both geographic levels, high-income and majority White geographic units had the lowest walkability overall. Walkability was lower with increasing tertile of median income among majority White, Latinx, and Asian American and Native Hawaiian and Pacific Islander neighborhoods. However, this association was reversed within majority Black neighborhoods, where tracts in lower-income tertiles had the lowest walkability. Associations varied substantially by region, with the strongest differences observed for cities located in the South. CONCLUSIONS:Differences in neighborhood walkability across 500 U.S. cities provide evidence that both geographic unit and region meaningfully influence associations between sociodemographic factors and walkability. Structural interventions to the built environment may improve equity in urban environments, particularly in lower-income majority Black neighborhoods.
PMID: 34108111
ISSN: 1873-2607
CID: 4936682

Using GFR, Albuminuria, and Their Changes in Clinical Trials and Clinical Care [Comment]

Coresh, Josef; Grams, Morgan E; Chen, Teresa K
PMID: 34059333
ISSN: 1523-6838
CID: 5101932

Proteins Associated with Risk of Kidney Function Decline in the General Population

Grams, Morgan E; Surapaneni, Aditya; Chen, Jingsha; Zhou, Linda; Yu, Zhi; Dutta, Diptavo; Welling, Paul A; Chatterjee, Nilanjan; Zhang, Jingning; Arking, Dan E; Chen, Teresa K; Rebholz, Casey M; Yu, Bing; Schlosser, Pascal; Rhee, Eugene P; Ballantyne, Christie M; Boerwinkle, Eric; Lutsey, Pamela L; Mosley, Thomas; Feldman, Harold I; Dubin, Ruth F; Ganz, Peter; Lee, Hongzhe; Zheng, Zihe; Coresh, Josef
BACKGROUND:Proteomic profiling may allow identification of plasma proteins that associate with subsequent changesin kidney function, elucidating biologic processes underlying the development and progression of CKD. METHODS:We quantified the association between 4877 plasma proteins and a composite outcome of ESKD or decline in eGFR by ≥50% among 9406 participants in the Atherosclerosis Risk in Communities (ARIC) Study (visit 3; mean age, 60 years) who were followed for a median of 14.4 years. We performed separate analyses for these proteins in a subset of 4378 participants (visit 5), who were followed at a later time point, for a median of 4.4 years. For validation, we evaluated proteins with significant associations (false discovery rate <5%) in both time periods in 3249 participants in the Chronic Renal Insufficiency Cohort (CRIC) and 703 participants in the African American Study of Kidney Disease and Hypertension (AASK). We also compared the genetic determinants of protein levels with those from a meta-analysis genome-wide association study of eGFR. RESULTS:-trace protein. Of these proteins, 12 were also significantly associated in CRIC, and nine were significantly associated in AASK. Higher levels of each protein associated with higher risk of 50% eGFR decline or ESKD. We found genetic evidence for a causal role for one protein, lectin mannose-binding 2 protein (LMAN2). CONCLUSIONS:Large-scale proteomic analysis identified both known and novel proteomic risk factors for eGFR decline.
PMID: 34465608
ISSN: 1533-3450
CID: 5101992

Leveraging Emergency Department Information Systems to Address Palliative Care Needs of ED Patients During the COVID Pandemic

Tan, Audrey J; Swartz, Jordan; Wilkins, Christine; Grudzen, Corita
The arrival of the COVID-19 pandemic to hospitals in New York City stressed our emergency departments (ED) with high patient volume, stresses on hospital resources and the arrival of numerous high acuity, critically ill patients. Amid this time, we sought to leverage the ED Information Systems (EDIS), to assist in connecting critically ill patients, their families, and providers in the ED with palliative care resources. We discuss 4 innovative, thoughtful solutions to assist ED providers in identifying and addressing the acute and unique palliative care needs of COVID patients.
PMID: 34463145
ISSN: 1938-2715
CID: 5011672

Rounding up the usual suspects: confirmation bias in epidemiological research

Braithwaite, R Scott; Ban, Kaoon Francois; Stevens, Elizabeth R; Caniglia, Ellen C
PMID: 33928375
ISSN: 1464-3685
CID: 4873822

Cardiovascular morbidity and mortality associations with biomass- and fossil-fuel-combustion fine-particulate-matter exposures in Dhaka, Bangladesh

Rahman, Md Mostafijur; Begum, Bilkis A; Hopke, Philip K; Nahar, Kamrun; Newman, Jonathan; Thurston, George D
BACKGROUND:Fine-particulate-matter (i.e. with an aerodynamic diameter of ≤2.5 µm, PM2.5) air pollution is commonly treated as if it had 'equivalent toxicity', irrespective of the source and composition. We investigate the respective roles of fossil-fuel- and biomass-combustion particles in the PM2.5 relationship with cardiovascular morbidity and mortality using tracers of sources in Dhaka, Bangladesh. Results provide insight into the often observed levelling of the PM2.5 exposure-response curve at high-pollution levels. METHODS:A time-series regression model, adjusted for potentially confounding influences, was applied to 340 758 cardiovascular disease (CVD) emergency-department visits (EDVs) during January 2014 to December 2017, 253 407 hospital admissions during September 2013 to December 2017 and 16 858 CVD deaths during January 2014 to October 2017. RESULTS:Significant associations were confirmed between PM2.5-mass exposures and increased risk of cardiovascular EDV [0.27%, (0.07% to 0.47%)] at lag-0, hospitalizations [0.32% (0.08% to 0.55%)] at lag-0 and deaths [0.87%, (0.27% to 1.47%)] at lag-1 per 10-μg/m3 increase in PM2.5. However, the relationship of PM2.5 with morbidity and mortality effect slopes was less steep and non-significant at higher PM2.5 concentrations (during crop-burning-dominated exposures) and varied with PM2.5 source. Fossil-fuel-combustion PM2.5 had roughly a four times greater effect on CVD mortality and double the effect on CVD hospital admissions on a per-µg/m3 basis than did biomass-combustion PM2.5. CONCLUSION/CONCLUSIONS:Biomass burning was responsible for most PM2.5 air pollution in Dhaka, but fossil-fuel-combustion PM2.5 dominated the CVD adverse health impacts. Such by-source variations in the health impacts of PM2.5 should be considered in conducting ambient particulate-matter risk assessments, as well as in prioritizing air-pollution-mitigation measures and clinical advice.
PMID: 33822936
ISSN: 1464-3685
CID: 4839162

Comparing Breast Cancer Experiences and Quality of Life between Lesbian and Heterosexual Women

Borowczak, Maya; Lee, Marie C; Weidenbaum, Emily; Mattingly, Anne; Kuritzky, Anne; Quinn, Gwendolyn P
BACKGROUND:While breast cancer among women in general has been well studied, little is known about breast cancer in sexual minority women (SMW). Aside from being at an increased risk for development of, and mortality from, breast cancer compared to their heterosexual counterparts, there is a growing collection of literature that suggests that SMW experience breast cancer differently to heterosexual women. METHODS:Qualitative study of both straight and lesbian women with a diagnosis of breast cancer. Focus groups were conducted to assess straight and SMW experiences pertaining to perceived barriers, resources/support from partners as well as attitudes pertaining to breast reconstruction. RESULTS:A sample of 15 participants (10 straight and 5 lesbian women) were included in the present study. Focus group themes focused on support, wishes for support, satisfaction with inclusion of partner, fear, perceived discrimination, quality of life, body image, treatment delay, financial concern, frustration with the system, reconstruction, access to information, and attitudes towards cancer diagnosis. A majority of women in both groups chose to undergo breast reconstruction. CONCLUSION/CONCLUSIONS:In our study, SMW experienced their breast cancer treatment through a uniquely supportive and positive lens, often with higher relationship satisfaction and better self-image when compared to straight women.
PMCID:8431629
PMID: 34503157
ISSN: 2072-6694
CID: 5012042

Trends in Prevalence of Type 1 and Type 2 Diabetes in Children and Adolescents in the US, 2001-2017

Lawrence, Jean M; Divers, Jasmin; Isom, Scott; Saydah, Sharon; Imperatore, Giuseppina; Pihoker, Catherine; Marcovina, Santica M; Mayer-Davis, Elizabeth J; Hamman, Richard F; Dolan, Lawrence; Dabelea, Dana; Pettitt, David J; Liese, Angela D
Importance:Changes in the prevalence of youth-onset diabetes have previously been observed. Objective:To estimate changes in prevalence of type 1 and type 2 diabetes in youths in the US from 2001 to 2017. Design, Setting, and Participants:In this cross-sectional observational study, individuals younger than 20 years with physician-diagnosed diabetes were enumerated from 6 areas in the US (4 geographic areas, 1 health plan, and select American Indian reservations) for 2001, 2009, and 2017. Exposures:Calendar year. Main Outcomes and Measures:Estimated prevalence of physician-diagnosed type 1 and type 2 diabetes overall and by race and ethnicity, age, and sex. Results:Among youths 19 years or younger, 4958 of 3.35 million had type 1 diabetes in 2001, 6672 of 3.46 million had type 1 diabetes in 2009, and 7759 of 3.61 million had type 1 diabetes in 2017; among those aged 10 to 19 years, 588 of 1.73 million had type 2 diabetes in 2001, 814 of 1.85 million had type 2 diabetes in 2009, and 1230 of 1.85 million had type 2 diabetes in 2017. The estimated type 1 diabetes prevalence per 1000 youths for those 19 years or younger increased significantly from 1.48 (95% CI, 1.44-1.52) in 2001 to 1.93 (95% CI, 1.88-1.98) in 2009 to 2.15 (95% CI, 2.10-2.20) in 2017, an absolute increase of 0.67 per 1000 youths (95%, CI, 0.64-0.70) and a 45.1% (95% CI, 40.0%-50.4%) relative increase over 16 years. The greatest absolute increases were observed among non-Hispanic White (0.93 per 1000 youths [95% CI, 0.88-0.98]) and non-Hispanic Black (0.89 per 1000 youths [95% CI, 0.88-0.98]) youths. The estimated type 2 diabetes prevalence per 1000 youths aged 10 to 19 years increased significantly from 0.34 (95% CI, 0.31-0.37) in 2001 to 0.46 (95% CI, 0.43-0.49) in 2009 to 0.67 (95% CI, 0.63-0.70) in 2017, an absolute increase of 0.32 per 1000 youths (95% CI, 0.30-0.35) and a 95.3% (95% CI, 77.0%-115.4%) relative increase over 16 years. The greatest absolute increases were observed among non-Hispanic Black (0.85 per 1000 youths [95% CI, 0.74-0.97]) and Hispanic (0.57 per 1000 youths [95% CI, 0.51-0.64]) youths. Conclusions and Relevance:In 6 areas of the US from 2001 to 2017, the estimated prevalence of diabetes among children and adolescents increased for both type 1 and type 2 diabetes.
PMCID:8385600
PMID: 34427600
ISSN: 1538-3598
CID: 5011072