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Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

Axfors, Cathrine; Schmitt, Andreas M; Janiaud, Perrine; Van't Hooft, Janneke; Abd-Elsalam, Sherief; Abdo, Ehab F; Abella, Benjamin S; Akram, Javed; Amaravadi, Ravi K; Angus, Derek C; Arabi, Yaseen M; Azhar, Shehnoor; Baden, Lindsey R; Baker, Arthur W; Belkhir, Leila; Benfield, Thomas; Berrevoets, Marvin A H; Chen, Cheng-Pin; Chen, Tsung-Chia; Cheng, Shu-Hsing; Cheng, Chien-Yu; Chung, Wei-Sheng; Cohen, Yehuda Z; Cowan, Lisa N; Dalgard, Olav; de Almeida E Val, Fernando F; de Lacerda, Marcus V G; de Melo, Gisely C; Derde, Lennie; Dubee, Vincent; Elfakir, Anissa; Gordon, Anthony C; Hernandez-Cardenas, Carmen M; Hills, Thomas; Hoepelman, Andy I M; Huang, Yi-Wen; Igau, Bruno; Jin, Ronghua; Jurado-Camacho, Felipe; Khan, Khalid S; Kremsner, Peter G; Kreuels, Benno; Kuo, Cheng-Yu; Le, Thuy; Lin, Yi-Chun; Lin, Wu-Pu; Lin, Tse-Hung; Lyngbakken, Magnus Nakrem; McArthur, Colin; McVerry, Bryan J; Meza-Meneses, Patricia; Monteiro, Wuelton M; Morpeth, Susan C; Mourad, Ahmad; Mulligan, Mark J; Murthy, Srinivas; Naggie, Susanna; Narayanasamy, Shanti; Nichol, Alistair; Novack, Lewis A; O'Brien, Sean M; Okeke, Nwora Lance; Perez, Léna; Perez-Padilla, Rogelio; Perrin, Laurent; Remigio-Luna, Arantxa; Rivera-Martinez, Norma E; Rockhold, Frank W; Rodriguez-Llamazares, Sebastian; Rolfe, Robert; Rosa, Rossana; Røsjø, Helge; Sampaio, Vanderson S; Seto, Todd B; Shahzad, Muhammad; Soliman, Shaimaa; Stout, Jason E; Thirion-Romero, Ireri; Troxel, Andrea B; Tseng, Ting-Yu; Turner, Nicholas A; Ulrich, Robert J; Walsh, Stephen R; Webb, Steve A; Weehuizen, Jesper M; Velinova, Maria; Wong, Hon-Lai; Wrenn, Rebekah; Zampieri, Fernando G; Zhong, Wu; Moher, David; Goodman, Steven N; Ioannidis, John P A; Hemkens, Lars G
PMID: 33990619
ISSN: 2041-1723
CID: 4876372

A prospective study of long-term outcomes among hospitalized COVID-19 patients with and without neurological complications

Frontera, Jennifer A; Yang, Dixon; Lewis, Ariane; Patel, Palak; Medicherla, Chaitanya; Arena, Vito; Fang, Taolin; Andino, Andres; Snyder, Thomas; Madhavan, Maya; Gratch, Daniel; Fuchs, Benjamin; Dessy, Alexa; Canizares, Melanie; Jauregui, Ruben; Thomas, Betsy; Bauman, Kristie; Olivera, Anlys; Bhagat, Dhristie; Sonson, Michael; Park, George; Stainman, Rebecca; Sunwoo, Brian; Talmasov, Daniel; Tamimi, Michael; Zhu, Yingrong; Rosenthal, Jonathan; Dygert, Levi; Ristic, Milan; Ishii, Haruki; Valdes, Eduard; Omari, Mirza; Gurin, Lindsey; Huang, Joshua; Czeisler, Barry M; Kahn, D Ethan; Zhou, Ting; Lin, Jessica; Lord, Aaron S; Melmed, Kara; Meropol, Sharon; Troxel, Andrea B; Petkova, Eva; Wisniewski, Thomas; Balcer, Laura; Morrison, Chris; Yaghi, Shadi; Galetta, Steven
BACKGROUND:Little is known regarding long-term outcomes of patients hospitalized with COVID-19. METHODS:We conducted a prospective study of 6-month outcomes of hospitalized COVID-19 patients. Patients with new neurological complications during hospitalization who survived were propensity score-matched to COVID-19 survivors without neurological complications hospitalized during the same period. The primary 6-month outcome was multivariable ordinal analysis of the modified Rankin Scale(mRS) comparing patients with or without neurological complications. Secondary outcomes included: activities of daily living (ADLs;Barthel Index), telephone Montreal Cognitive Assessment and Neuro-QoL batteries for anxiety, depression, fatigue and sleep. RESULTS:Of 606 COVID-19 patients with neurological complications, 395 survived hospitalization and were matched to 395 controls; N = 196 neurological patients and N = 186 controls completed follow-up. Overall, 346/382 (91%) patients had at least one abnormal outcome: 56% had limited ADLs, 50% impaired cognition, 47% could not return to work and 62% scored worse than average on ≥1 Neuro-QoL scale (worse anxiety 46%, sleep 38%, fatigue 36%, and depression 25%). In multivariable analysis, patients with neurological complications had worse 6-month mRS (median 4 vs. 3 among controls, adjusted OR 1.98, 95%CI 1.23-3.48, P = 0.02), worse ADLs (aOR 0.38, 95%CI 0.29-0.74, P = 0.01) and were less likely to return to work than controls (41% versus 64%, P = 0.04). Cognitive and Neuro-QOL metrics were similar between groups. CONCLUSIONS:Abnormalities in functional outcomes, ADLs, anxiety, depression and sleep occurred in over 90% of patients 6-months after hospitalization for COVID-19. In multivariable analysis, patients with neurological complications during index hospitalization had significantly worse 6-month functional outcomes than those without.
PMCID:8113108
PMID: 34000678
ISSN: 1878-5883
CID: 4876752

Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

Axfors, Cathrine; Schmitt, Andreas M; Janiaud, Perrine; Van't Hooft, Janneke; Abd-Elsalam, Sherief; Abdo, Ehab F; Abella, Benjamin S; Akram, Javed; Amaravadi, Ravi K; Angus, Derek C; Arabi, Yaseen M; Azhar, Shehnoor; Baden, Lindsey R; Baker, Arthur W; Belkhir, Leila; Benfield, Thomas; Berrevoets, Marvin A H; Chen, Cheng-Pin; Chen, Tsung-Chia; Cheng, Shu-Hsing; Cheng, Chien-Yu; Chung, Wei-Sheng; Cohen, Yehuda Z; Cowan, Lisa N; Dalgard, Olav; de Almeida E Val, Fernando F; de Lacerda, Marcus V G; de Melo, Gisely C; Derde, Lennie; Dubee, Vincent; Elfakir, Anissa; Gordon, Anthony C; Hernandez-Cardenas, Carmen M; Hills, Thomas; Hoepelman, Andy I M; Huang, Yi-Wen; Igau, Bruno; Jin, Ronghua; Jurado-Camacho, Felipe; Khan, Khalid S; Kremsner, Peter G; Kreuels, Benno; Kuo, Cheng-Yu; Le, Thuy; Lin, Yi-Chun; Lin, Wu-Pu; Lin, Tse-Hung; Lyngbakken, Magnus Nakrem; McArthur, Colin; McVerry, Bryan J; Meza-Meneses, Patricia; Monteiro, Wuelton M; Morpeth, Susan C; Mourad, Ahmad; Mulligan, Mark J; Murthy, Srinivas; Naggie, Susanna; Narayanasamy, Shanti; Nichol, Alistair; Novack, Lewis A; O'Brien, Sean M; Okeke, Nwora Lance; Perez, Léna; Perez-Padilla, Rogelio; Perrin, Laurent; Remigio-Luna, Arantxa; Rivera-Martinez, Norma E; Rockhold, Frank W; Rodriguez-Llamazares, Sebastian; Rolfe, Robert; Rosa, Rossana; Røsjø, Helge; Sampaio, Vanderson S; Seto, Todd B; Shehzad, Muhammad; Soliman, Shaimaa; Stout, Jason E; Thirion-Romero, Ireri; Troxel, Andrea B; Tseng, Ting-Yu; Turner, Nicholas A; Ulrich, Robert J; Walsh, Stephen R; Webb, Steve A; Weehuizen, Jesper M; Velinova, Maria; Wong, Hon-Lai; Wrenn, Rebekah; Zampieri, Fernando G; Zhong, Wu; Moher, David; Goodman, Steven N; Ioannidis, John P A; Hemkens, Lars G
Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.
PMID: 33859192
ISSN: 2041-1723
CID: 4846322

Effect of citalopram on hippocampal volume in first-episode schizophrenia: Structural MRI results from the DECIFER trial

Qi, Wei; Blessing, Esther; Li, Chenxiang; Ardekani, Babak A; Hart, Kamber L; Marx, Julia; Freudenreich, Oliver; Cather, Corinne; Holt, Daphne; Bello, Iruma; Diminich, Erica D; Tang, Yingying; Worthington, Michelle; Zeng, Botao; Wu, Renrong; Fan, Xiaoduo; Troxel, Andrea; Zhao, Jingping; Wang, Jijun; Goff, Donald C
Hippocampal volume loss is prominent in first episode schizophrenia (FES) and has been associated with poor clinical outcomes and with BDNF genotype; antidepressants are believed to reverse hippocampal volume loss via release of BDNF. In a 12-month, placebo-controlled add-on trial of the antidepressant, citalopram, during the maintenance phase of FES, negative symptoms were improved with citalopram. We now report results of structural brain imaging at baseline and 6 months in 63 FES patients (34 in citalopram group) from the trial to assess whether protection against hippocampal volume loss contributed to improved negative symptoms with citalopram. Hippocampal volumetric integrity (HVI) did not change significantly in the citalopram or placebo group and did not differ between treatment groups, whereas citalopram was associated with greater volume loss of the right CA1 subfield. Change in cortical thickness was associated with SANS change in 4 regions (left rostral anterior cingulate, right frontal pole, right cuneus, and right transverse temporal) but none differed between treatment groups. Our findings suggest that minimal hippocampal volume loss occurs after stabilization on antipsychotic treatment and that citalopram's potential benefit for negative symptoms is unlikely to result from protection against hippocampal volume loss or cortical thinning.
PMID: 33857750
ISSN: 1872-7506
CID: 4851292

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

Northridge, Mary E; Wu, Yinxiang; Troxel, Andrea B; Min, Deborah; Liu, Rong; Liang, Li Juan; Metcalf, Sara S; Seyedzadeh Sabounchi, Shabnam; Yi, Stella
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/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/CONCLUSIONS: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.
PMID: 33368603
ISSN: 1741-2358
CID: 4762272

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

Robbins, Rebecca; DiClemente, Ralph J; Troxel, Andrea B; Jean-Louis, Girardin; Butler, Mark; Rapoport, David M; Czeisler, Charles A
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.
PMID: 33248901
ISSN: 1878-5506
CID: 4693712

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

Frontera, Jennifer A; Sabadia, Sakinah; Lalchan, Rebecca; Fang, Taolin; Flusty, Brent; Millar-Vernetti, Patricio; Snyder, Thomas; Berger, Stephen; Yang, Dixon; Granger, Andre; Morgan, Nicole; Patel, Palak; Gutman, Josef; Melmed, Kara; Agarwal, Shashank; Bokhari, Matthew; Andino, Andres; Valdes, Eduard; Omari, Mirza; Kvernland, Alexandra; Lillemoe, Kaitlyn; Chou, Sherry H-Y; McNett, Molly; Helbok, Raimund; Mainali, Shraddha; Fink, Ericka L; Robertson, Courtney; Schober, Michelle; Suarez, Jose I; Ziai, Wendy; Menon, David; Friedman, Daniel; Friedman, David; Holmes, Manisha; Huang, Joshua; Thawani, Sujata; Howard, Jonathan; Abou-Fayssal, Nada; Krieger, Penina; Lewis, Ariane; Lord, Aaron S; Zhou, Ting; Kahn, D Ethan; Czeisler, Barry M; Torres, Jose; Yaghi, Shadi; Ishida, Koto; Scher, Erica; de Havenon, Adam; Placantonakis, Dimitris; Liu, Mengling; Wisniewski, Thomas; Troxel, Andrea B; Balcer, Laura; Galetta, Steven
OBJECTIVE:To determine the prevalence and associated mortality of well-defined neurologic diagnoses among COVID-19 patients, we prospectively followed hospitalized SARS-Cov-2 positive patients and recorded new neurologic disorders and hospital outcomes. METHODS:We conducted a prospective, multi-center, observational study of consecutive hospitalized adults in the NYC 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 COVID-19 patients with and without neurologic disorders. RESULTS:Of 4,491 COVID-19 patients 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 RT-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 P<0.05). After adjusting for age, sex, SOFA-scores, intubation, past history, medical complications, medications and comfort-care-status, COVID-19 patients with neurologic disorders had increased risk of in-hospital mortality (Hazard Ratio[HR] 1.38, 95% CI 1.17-1.62, P<0.001) and decreased likelihood of discharge home (HR 0.72, 95% CI 0.63-0.85, P<0.001). CONCLUSIONS:Neurologic disorders were detected in 13.5% of COVID-19 patients 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.
PMID: 33020166
ISSN: 1526-632x
CID: 4626712

Pragmatic randomized trials for behavioral health or educational interventions

Chapter by: Troxel, Andrea B.
in: Pragmatic Randomized Clinical Trials: Using Primary Data Collection and Electronic Health Records by
[S.l.] : Elsevier, 2021
pp. 413-426
ISBN: 9780128176634
CID: 5189462

Partial-Linear Single-Index Cox Regression with Multiple Time-Dependent Covariates

Chapter by: Lee, Myeonggyun; Troxel, Andrea B; Kwon, Sophia; Nolan, Anna
in: JSM 2021 Online Program by
[S.l.] : JSM, 2021
pp. -
ISBN: n/a
CID: 5524422

Implementation of a behavioral economics electronic health record (BE-EHR) module to optimize diabetes management in older adults [Meeting Abstract]

Belli, Hayley; Troxel, Andrea; Blecker, Saul; Anderman, Judd; Wong, Christina; Martinez, Tiffany; Mann, Devin
ISI:000652220000049
ISSN: 1748-5908
CID: 4894012