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1.
J Biopharm Stat ; 32(1): 204-218, 2022 01 02.
Article in English | MEDLINE | ID: covidwho-1873726

ABSTRACT

Randomized controlled trials (RCTs) are the gold standard for evaluation of new medical products. However, RCTs may not always be ethical or feasible. In cases where the investigational product is available outside the trial (e.g., through accelerated approval), patients may fail to enroll in clinical trials or drop out early to take the investigational product. These challenges to enrolling or maintaining a concurrent control arm may compromise timely recruitment, retention, or compliance. This can threaten the study's integrity, including the validity of results. External control arms (ECAs) may be a promising augmentation to RCTs when encountered with challenges that threaten the feasibility and reliability of a randomized controlled clinical trial. Here, we propose the use of ECAs created from patient-level data from previously conducted clinical trials or real-world data in the same indication. Propensity score methods are used to balance observed disease characteristics and demographics in the previous clinical trial or real-world data with those of present-day trial participants assigned to receive the investigational product. These methods are explored in a case study in non-small cell lung cancer (NSCLC) derived from multiple previously conducted open label or blinded phase 2 and 3 multinational clinical trials initiated between 2004 and 2013. The case study indicated that when balanced for baseline characteristics, the overall survival estimates from the ECA were very similar to those of the target randomized control, based on Kaplan-Meier curves and hazard ratio and confidence interval estimates. This suggests that in the future, a randomized control may be able to be augmented by an ECA without compromising the understanding of the treatment effect, assuming sufficient knowledge, measurement, and availability of all or most of the important prognostic variables.


Subject(s)
COVID-19 , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Carcinoma, Non-Small-Cell Lung/drug therapy , Humans , Lung Neoplasms/drug therapy , SARS-CoV-2 , Treatment Outcome
2.
Sci Adv ; 8(16): eabm9128, 2022 Apr 22.
Article in English | MEDLINE | ID: covidwho-1807301

ABSTRACT

Because of the importance of schools to childhood development, the relationship between in-person schooling and COVID-19 risk has been one of the most important questions of this pandemic. Previous work in the United States during winter 2020-2021 showed that in-person schooling carried some risk for household members and that mitigation measures reduced this risk. Schooling and the COVID-19 landscape changed radically over spring semester 2021. Here, we use data from a massive online survey to characterize changes in in-person schooling behavior and associated risks over that period. We find increases in in-person schooling and reductions in mitigations over time. In-person schooling is associated with increased reporting of COVID-19 outcomes even among vaccinated individuals (although the absolute risk among the vaccinated is greatly reduced). Vaccinated teachers working outside the home were less likely to report COVID-19-related outcomes than unvaccinated teachers working exclusively from home. Adequate mitigation measures appear to eliminate the excess risk associated with in-person schooling.

3.
BMC Health Serv Res ; 22(1): 418, 2022 Mar 30.
Article in English | MEDLINE | ID: covidwho-1770536

ABSTRACT

BACKGROUND: Opioid treatment programs (OTPs) serve as daily essential services for people with opioid use disorder. This study seeks to identify modifications to operations and adoption of safety measures at Pennsylvania OTPs during the COVID-19 pandemic. METHODS: A 25-min online survey to clinical and administrative directors at all 103 state-licensed OTPs in Pennsylvania was fielded from September to November 2020. Survey domains included: 1) changes to services, client volume, hours and staffing during the COVID-19 pandemic 2) types of services modifications 3) safety protocols to reduce COVID-19 transmission 4) challenges to operations during the pandemic. RESULTS: Forty-seven directors responded, for a response rate of 45%. Almost all respondents reported making some service modification (96%, n = 43). Almost half (47%, n = 21) of respondents reported reductions in the number of clients served. OTPs were more likely to adopt safety protocols that did not require significant funding, such as limiting the number of people entering the site (100%, n = 44), posting COVID-safety information (100%, n = 44), enforcing social distancing (98%, n = 43), and increasing sanitation (100%, n = 44). Only 34% (n = 14) of OTPS provided N95 masks to most or all staff. Respondents reported that staff's stress and negative mental health (86%, n = 38) and staff caregiving responsibilities (84%, n = 37) during the pandemic were challenges to maintaining OTP operations. CONCLUSION: OTPs faced numerous challenges to operations and adoption of safety measures during the COVID-19 pandemic. Funding mechanisms and interventions to improve adoption of safety protocols, staff mental health as well as research on patient experiences and preferences can inform further OTP adaptation to the COVID-19 pandemic and future emergency planning.


Subject(s)
COVID-19 , Opioid-Related Disorders , Analgesics, Opioid/therapeutic use , COVID-19/epidemiology , Humans , Opioid-Related Disorders/drug therapy , Opioid-Related Disorders/epidemiology , Opioid-Related Disorders/prevention & control , Pandemics/prevention & control , Surveys and Questionnaires
4.
Int J Public Health ; 67: 1604430, 2022.
Article in English | MEDLINE | ID: covidwho-1753425

ABSTRACT

Objectives: To examine the association of non-pharmaceutical interventions (NPIs) with anxiety and depressive symptoms among adults and determine if these associations varied by gender and age. Methods: We combined survey data from 16,177,184 adults from 43 countries who participated in the daily COVID-19 Trends and Impact Survey via Facebook with time-varying NPI data from the Oxford COVID-19 Government Response Tracker between 24 April 2020 and 20 December 2020. Using logistic regression models, we examined the association of [1] overall NPI stringency and [2] seven individual NPIs (school closures, workplace closures, cancellation of public events, restrictions on the size of gatherings, stay-at-home requirements, restrictions on internal movement, and international travel controls) with anxiety and depressive symptoms. Results: More stringent implementation of NPIs was associated with a higher odds of anxiety and depressive symptoms, albeit with very small effect sizes. Individual NPIs had heterogeneous associations with anxiety and depressive symptoms by gender and age. Conclusion: Governments worldwide should be prepared to address the possible mental health consequences of stringent NPI implementation with both universal and targeted interventions for vulnerable groups.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Anxiety/epidemiology , Anxiety/prevention & control , Anxiety Disorders , COVID-19/epidemiology , COVID-19/prevention & control , Depression/epidemiology , Depression/prevention & control , Humans
5.
J Addict Med ; 2022 Feb 14.
Article in English | MEDLINE | ID: covidwho-1684847

ABSTRACT

OBJECTIVES: We sought to understand how opioid treatment programs (OTPs) adapted OTP operations to the COVID-19 pandemic and new federal regulations around methadone and buprenorphine. METHODS: In fall 2020, we conducted an online survey of all 103 OTPs licensed by the Pennsylvania Department of Drug and Alcohol Programs, including clinical directors. Survey domains included changes to methadone take-home and telehealth practices; overdose and diversion prevention tactics; perceptions regarding how such changes influence patient well-being; and financial/operational concerns related to the new policies and practices. We calculated descriptive statistics and conducted Chi-square test to test for differences between not-for-profit versus for-profit and large versus small OTPs. RESULTS: Forty-seven percent (46%) OTPs responded to the survey. 10% and 25%, respectively, endorsed offering telephone and video-based telemedicine buprenorphine induction. Sixty-six percent endorsed extending take-home supplies of methadone, but most indicated that these extensions applied to a minority of their patients. Most respondents agreed that provision of buprenorphine via telehealth and extended take-home methadone reduced patient burden in accessing medications and prevented exposure to COVID-19, while not significantly increasing risk of overdose. We did not find major differences in COVID-19 practice modifications by nonprofit status or size of OTP. CONCLUSIONS: In Pennsylvania, the COVID-19 pandemic led to rapid changes in provision of opioid treatment services. Findings on relatively low uptake of longer methadone take-home regimens and virtual buprenorphine initiation despite general support for these practices imply a need to further develop guidelines for best clinical practices and understand/address barriers to their implementation.

6.
BMJ Open ; 12(1): e053820, 2022 01 11.
Article in English | MEDLINE | ID: covidwho-1632977

ABSTRACT

INTRODUCTION: Assessing the impact of COVID-19 policy is critical for informing future policies. However, there are concerns about the overall strength of COVID-19 impact evaluation studies given the circumstances for evaluation and concerns about the publication environment. METHODS: We included studies that were primarily designed to estimate the quantitative impact of one or more implemented COVID-19 policies on direct SARS-CoV-2 and COVID-19 outcomes. After searching PubMed for peer-reviewed articles published on 26 November 2020 or earlier and screening, all studies were reviewed by three reviewers first independently and then to consensus. The review tool was based on previously developed and released review guidance for COVID-19 policy impact evaluation. RESULTS: After 102 articles were identified as potentially meeting inclusion criteria, we identified 36 published articles that evaluated the quantitative impact of COVID-19 policies on direct COVID-19 outcomes. Nine studies were set aside because the study design was considered inappropriate for COVID-19 policy impact evaluation (n=8 pre/post; n=1 cross-sectional), and 27 articles were given a full consensus assessment. 20/27 met criteria for graphical display of data, 5/27 for functional form, 19/27 for timing between policy implementation and impact, and only 3/27 for concurrent changes to the outcomes. Only 4/27 were rated as overall appropriate. Including the 9 studies set aside, reviewers found that only four of the 36 identified published and peer-reviewed health policy impact evaluation studies passed a set of key design checks for identifying the causal impact of policies on COVID-19 outcomes. DISCUSSION: The reviewed literature directly evaluating the impact of COVID-19 policies largely failed to meet key design criteria for inference of sufficient rigour to be actionable by policy-makers. More reliable evidence review is needed to both identify and produce policy-actionable evidence, alongside the recognition that actionable evidence is often unlikely to be feasible.


Subject(s)
COVID-19 , Cross-Sectional Studies , Health Policy , Humans , Research Design , SARS-CoV-2
7.
Addiction ; 117(2): 331-340, 2022 02.
Article in English | MEDLINE | ID: covidwho-1612824

ABSTRACT

AIMS: To examine changes in drinking behavior among United States (US) adults between March 10 and July 21, 2020, a critical period during the COVID-19 pandemic. DESIGN: Longitudinal, internet-based panel survey. SETTING: The Understanding America Study (UAS), a nationally representative panel of US adults age 18 or older. PARTICIPANTS: A total of 4298 US adults who reported alcohol use. MEASUREMENTS: Changes in number of reported drinking days from March 11, 2020 through July 21, 2020 in the overall sample and stratified by sex, age, race/ethnicity, household structure, poverty status, and census region. FINDINGS: Compared with March 11, the number of drinking days per week was significantly higher on April 1 by an average of 0.36 days (95% CI = 0.30, 0.43), on May 1 by an average of 0.55 days (95% CI = 0.47, 0.63), on June 1 by an average of 0.41 days (95% CI = 0.33, 0.49), and on July 1 by an average of 0.39 days (95% CI = 0.31, 0.48). Males, White participants, and older adults reported sustained increases in drinking days, whereas female participants and individuals living under the federal poverty line had attenuated drinking days in the latter part of the study period. CONCLUSIONS: Between March and mid-July 2020, adults in the United States reported increases in the number of drinking days, with sustained increases observed among males, White participants, and older adults.


Subject(s)
COVID-19 , Adolescent , Aged , Alcohol Drinking/epidemiology , Ethnicity , Female , Humans , Male , Pandemics , SARS-CoV-2 , United States/epidemiology
8.
J Community Psychol ; 50(5): 2431-2442, 2022 07.
Article in English | MEDLINE | ID: covidwho-1589062

ABSTRACT

The objective of this study is to determine county-level factors associated with anxiety, depression, and isolation during the coronavirus disease 2019 (COVID-19) pandemic. This study used daily data from 23,592,355 respondents of a nationwide Facebook-based survey from April 2020 to July 2021, aggregated to the week-county level to yield 212,581 observations. Mental distress prevalences were modeled using weighted linear mixed-effects models with a county random effect. These models revealed that weekly percentages of mental distress were higher in counties with higher unemployment rates, populations, and education levels; higher percentages of females, young adults, individuals with a medical condition, and individuals very worried about their finances and COVID-19; and lower percentages of individuals who were working outside the home, living with children, without health insurance, and Black. Anxiety peaked in April 2020, depression in October 2020, and isolation in December 2020. Therefore, United States counties experienced the mental health effects of the pandemic differently dependent upon their characteristics, and mental distress prevalence varied across time.


Subject(s)
COVID-19 , Anxiety/epidemiology , Child , Female , Humans , Mental Health , Pandemics , SARS-CoV-2 , Young Adult
9.
Fam Syst Health ; 40(1): 46-59, 2022 03.
Article in English | MEDLINE | ID: covidwho-1586009

ABSTRACT

PURPOSE: The objectives of the current study were to (1) assess associations between household structure (i.e., living with spouse compared to living alone, with children, or with a spouse and children), presence of children, and mental distress in April 2020 and change in mental distress (between April and August 2020); and (2) determine whether these associations are moderated by income or sex. PARTICIPANTS: A total of 2,214 adults aged 25-55 from the April and August 2020 waves of the Understanding America study were included in the analytic sample. STUDY METHOD: Multivariable, survey-weighted linear regression models were used to examine associations between explanatory variables (i.e., household structure and number of children) and outcome variables (mental distress in April and change in mental distress), measured via the Patient Health Questionnaire (PHQ)-4. RESULTS: In adjusted models, each additional child under the age of 12 was associated with lower mental distress in April 2020 (ß = -.30, p = .002). Having children aged 13 to 18 and household structure were not significantly associated with mental distress. In interaction models, living with children only was associated with decreased mental distress among individuals reporting low income (interaction ß = -1.28, p = .016) but not high income. Similarly, living with children only was associated with decreased mental distress in females (interaction ß = -1.09, p = .025) but not males. CONCLUSION: This study supports prior literature that demonstrates the positive association of child rearing with psychological well-being and suggests that these benefits may be present even under stay-at-home orders in the early stages of the U.S. COVID-19 pandemic. (PsycInfo Database Record (c) 2022 APA, all rights reserved).


Subject(s)
COVID-19 , Mental Disorders , Psychological Distress , Adolescent , Adult , COVID-19/epidemiology , Family Characteristics , Female , Humans , Middle Aged , Pandemics
10.
PLoS One ; 16(12): e0261115, 2021.
Article in English | MEDLINE | ID: covidwho-1574235

ABSTRACT

BACKGROUND: The United States is experiencing a drug addiction and overdose crisis, made worse by the COVID-19 pandemic. Relative to other types of health services, addiction treatment and overdose prevention services are particularly vulnerable to disaster-related disruptions for multiple reasons including fragmentation from the general medical system and stigma, which may lead decisionmakers and providers to de-prioritize these services during disasters. In response to the COVID-19 pandemic, U.S. states implemented multiple policies designed to mitigate disruptions to addiction treatment and overdose prevention services, for example policies expanding access to addiction treatment delivered via telehealth and policies designed to support continuity of naloxone distribution programs. There is limited evidence on the effects of these policies on addiction treatment and overdose. This evidence is needed to inform state policy design in future disasters, as well as to inform decisions regarding whether to sustain these policies post-pandemic. METHODS: The overall study uses a concurrent-embedded design. Aims 1-2 use difference-in-differences analyses of large-scale observational databases to examine how state policies designed to mitigate the effects of the COVID-19 pandemic on health services delivery influenced addiction treatment delivery and overdose during the pandemic. Aim 3 uses a qualitative embedded multiple case study approach, in which we characterize local implementation of the state policies of interest; most public health disaster policies are enacted at the state level but implemented at the local level by healthcare systems and local public health authorities. DISCUSSION: Triangulation of results across methods will yield robust understanding of whether and how state disaster-response policies influenced drug addiction treatment and overdose during the COVID-19 pandemic. Results will inform policy enactment and implementation in future public health disasters. Results will also inform decisions about whether to sustain COVID-19 pandemic-related changes to policies governing delivery addiction and overdose prevention services long-term.


Subject(s)
COVID-19 , Delivery of Health Care/methods , Drug Overdose/drug therapy , Substance-Related Disorders/therapy , Disasters , Drug Overdose/mortality , Health Policy , Health Services , Humans , Outcome and Process Assessment, Health Care , United States
12.
BMC Public Health ; 21(1): 2099, 2021 11 15.
Article in English | MEDLINE | ID: covidwho-1518268

ABSTRACT

BACKGROUND: Guidelines and recommendations from public health authorities related to face masks have been essential in containing the COVID-19 pandemic. We assessed the prevalence and correlates of mask usage during the pandemic. METHODS: We examined a total of 13,723,810 responses to a daily cross-sectional online survey in 38 countries of people who completed from April 23, 2020 to October 31, 2020 and reported having been in public at least once during the last 7 days. The outcome was individual face mask usage in public settings, and the predictors were country fixed effects, country-level mask policy stringency, calendar time, individual sociodemographic factors, and health prevention behaviors. Associations were modeled using survey-weighted multivariable logistic regression. RESULTS: Mask-wearing varied over time and across the 38 countries. While some countries consistently showed high prevalence throughout, in other countries mask usage increased gradually, and a few other countries remained at low prevalence. Controlling for time and country fixed effects, sociodemographic factors (older age, female gender, education, urbanicity) and stricter mask-related policies were significantly associated with higher mask usage in public settings. Crucially, social behaviors considered risky in the context of the pandemic (going out to large events, restaurants, shopping centers, and socializing outside of the household) were associated with lower mask use. CONCLUSION: The decision to wear a face mask in public settings is significantly associated with sociodemographic factors, risky social behaviors, and mask policies. This has important implications for health prevention policies and messaging, including the potential need for more targeted policy and messaging design.


Subject(s)
COVID-19 , Pandemics , Aged , Cross-Sectional Studies , Female , Humans , Masks , SARS-CoV-2
13.
Am J Epidemiol ; 190(11): 2474-2486, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1493669

ABSTRACT

Policy responses to coronavirus disease 2019 (COVID-19), particularly those related to nonpharmaceutical interventions, are unprecedented in scale and scope. However, evaluations of policy impacts require a complex combination of circumstance, study design, data, statistics, and analysis. Beyond the issues that are faced for any policy, evaluation of COVID-19 policies is complicated by additional challenges related to infectious disease dynamics and a multiplicity of interventions. The methods needed for policy-level impact evaluation are not often used or taught in epidemiology, and they differ in important ways that may not be obvious. Methodological complications of policy evaluations can make it difficult for decision-makers and researchers to synthesize and evaluate the strength of the evidence in COVID-19 health policy papers. Here we 1) introduce the basic suite of policy-impact evaluation designs for observational data, including cross-sectional analyses, pre-/post- analyses, interrupted time-series analysis, and difference-in-differences analysis; 2) demonstrate key ways in which the requirements and assumptions underlying these designs are often violated in the context of COVID-19; and 3) provide decision-makers and reviewers with a conceptual and graphical guide to identifying these key violations. Our overall goal is to help epidemiologists, policy-makers, journal editors, journalists, researchers, and other research consumers understand and weigh the strengths and limitations of evidence.


Subject(s)
COVID-19 , Health Policy , Bias , Humans , Interrupted Time Series Analysis , SARS-CoV-2
14.
Int J Drug Policy ; 100: 103517, 2022 02.
Article in English | MEDLINE | ID: covidwho-1487690

ABSTRACT

BACKGROUND: The COVID-19 pandemic has had an impact on mental health and alcohol use in the US, however there is little research on its impacts on cannabis use. Considering the role of cannabis as a coping strategy or self-medicating behavior, there is a need to understand how individuals who use cannabis have adapted their use amid the pandemic. Therefore, this study examined changes in self-reported cannabis use among US adults in the context of COVID-19 pandemic by (1) describing trends of use during the first 8 months of the pandemic among adults who used cannabis in this period; and (2) characterizing trends of use within sociodemographic subgroups and by state cannabis policy status. METHODS: The sample consisted of 1,761 US adults who used cannabis at least once during the 8-month study period from the nationally representative Understanding America Study. Linear mixed-effect models were used to model changes in the number of days of past-week cannabis use across 16 waves from March 10, 2020, to November 11, 2020. RESULTS: Compared to early March, the number of days cannabis was used per week was significantly higher at the start of April (ß=0.11, 95% CI=0.03, 0.18) and May (ß=0.21,95% CI=0.05, 0.36). In subsequent months (June - November), the number of days of cannabis use attenuated to levels comparable to March. Trends of cannabis use across the study period generally did not differ across sociodemographic characteristics and state cannabis policy status. CONCLUSION: Though increases in use were marginal among many groups, the evolving pandemic and the growing concern for the mental health of segments of the U.S. population warrant close monitoring of coping behaviors, including substance use.


Subject(s)
COVID-19 , Cannabis , Adult , Humans , Pandemics , SARS-CoV-2 , Self Report
15.
Addiction ; 117(2): 331-340, 2022 02.
Article in English | MEDLINE | ID: covidwho-1413284

ABSTRACT

AIMS: To examine changes in drinking behavior among United States (US) adults between March 10 and July 21, 2020, a critical period during the COVID-19 pandemic. DESIGN: Longitudinal, internet-based panel survey. SETTING: The Understanding America Study (UAS), a nationally representative panel of US adults age 18 or older. PARTICIPANTS: A total of 4298 US adults who reported alcohol use. MEASUREMENTS: Changes in number of reported drinking days from March 11, 2020 through July 21, 2020 in the overall sample and stratified by sex, age, race/ethnicity, household structure, poverty status, and census region. FINDINGS: Compared with March 11, the number of drinking days per week was significantly higher on April 1 by an average of 0.36 days (95% CI = 0.30, 0.43), on May 1 by an average of 0.55 days (95% CI = 0.47, 0.63), on June 1 by an average of 0.41 days (95% CI = 0.33, 0.49), and on July 1 by an average of 0.39 days (95% CI = 0.31, 0.48). Males, White participants, and older adults reported sustained increases in drinking days, whereas female participants and individuals living under the federal poverty line had attenuated drinking days in the latter part of the study period. CONCLUSIONS: Between March and mid-July 2020, adults in the United States reported increases in the number of drinking days, with sustained increases observed among males, White participants, and older adults.


Subject(s)
COVID-19 , Adolescent , Aged , Alcohol Drinking/epidemiology , Ethnicity , Female , Humans , Male , Pandemics , SARS-CoV-2 , United States/epidemiology
16.
Front Pharmacol ; 12: 700776, 2021.
Article in English | MEDLINE | ID: covidwho-1359214

ABSTRACT

Since the beginning of the COVID-19 pandemic, pharmaceutical treatment hypotheses have abounded, each requiring careful evaluation. A randomized controlled trial generally provides the most credible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial. An observational study can provide this evidence, but the lack of randomized exposure and the researcher's inability to control treatment administration and data collection introduce significant challenges. A proper analysis of observational health care data thus requires contributions from experts in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. Here we summarize these contributions as 10 rules that serve as an end-to-end introduction to retrospective pharmacoepidemiological analyses of observational health care data using a running example of a hypothetical COVID-19 study. A detailed supplement presents a practical how-to guide for following each rule. When carefully designed and properly executed, a retrospective pharmacoepidemiological analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial. This work has important implications for any future pandemic by prescribing what we can and should do while the world waits for global vaccine distribution.

17.
Autism Res ; 14(10): 2183-2188, 2021 10.
Article in English | MEDLINE | ID: covidwho-1344962

ABSTRACT

The COVID-19 pandemic may disproportionately impact parents of children with autism spectrum disorder (ASD). Loss of services and supports, heightened fears about increased infection rates, and disruption of daily routines likely adversely affect the well-being of children with ASD and their families. The goal of this study was to examine differences in psychological distress-as defined by symptoms of anxiety, depression, loneliness, and hyperarousal-between parents raising a child with ASD and parents in the US as a whole during the early stages of the pandemic (March-April 2020). Parents raising a child with ASD (n = 3556) were recruited through SPARK, a national ASD research registry, whereas a representative sample of parents in the US (n = 5506) were recruited from the Pew Research Center's American Trends Panel. All data were captured via online surveys. Descriptive statistics and multivariable logistic regressions examined psychological distress at the item and summary score level. Parents of children with ASD reported higher levels of overall psychological distress (48% vs. 25%; aOR = 1.60, 95% CI: 1.32, 1.84, p < 0.001). Hyperarousal, or feelings of panic when thinking about COVID-19, was particularly prevalent among parents of children with ASD compared to parents in the US (25% vs. 9%; aOR = 2.38, 95% CI: 1.83, 3.07, p < 0.001). Findings highlight the importance of considering the policies and practices that contribute to poor mental health in parents, particularly those raising a child with ASD, to ensure mental health services remain accessible. LAY SUMMARY: This study examined the mental health of parents raising a child with ASD during the early stages of the COVID-19 pandemic. Results demonstrated substantially higher levels of psychological distress, particularly those related to feelings of panic, among parents raising a child with ASD when compared to parents in the US as a whole. These data suggest the need for ensuring mental health services are accessible to parents, particularly those raising a child with ASD, during and after the pandemic.


Subject(s)
Autism Spectrum Disorder , COVID-19 , Psychological Distress , Autism Spectrum Disorder/complications , Autism Spectrum Disorder/epidemiology , Caregivers , Child , Humans , Pandemics , Parents , SARS-CoV-2 , Stress, Psychological/complications , Stress, Psychological/epidemiology , United States/epidemiology
18.
Journal of Research on Educational Effectiveness ; : 1-8, 2021.
Article in English | Taylor & Francis | ID: covidwho-1334136
19.
Am J Epidemiol ; 190(11): 2474-2486, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1284854

ABSTRACT

Policy responses to coronavirus disease 2019 (COVID-19), particularly those related to nonpharmaceutical interventions, are unprecedented in scale and scope. However, evaluations of policy impacts require a complex combination of circumstance, study design, data, statistics, and analysis. Beyond the issues that are faced for any policy, evaluation of COVID-19 policies is complicated by additional challenges related to infectious disease dynamics and a multiplicity of interventions. The methods needed for policy-level impact evaluation are not often used or taught in epidemiology, and they differ in important ways that may not be obvious. Methodological complications of policy evaluations can make it difficult for decision-makers and researchers to synthesize and evaluate the strength of the evidence in COVID-19 health policy papers. Here we 1) introduce the basic suite of policy-impact evaluation designs for observational data, including cross-sectional analyses, pre-/post- analyses, interrupted time-series analysis, and difference-in-differences analysis; 2) demonstrate key ways in which the requirements and assumptions underlying these designs are often violated in the context of COVID-19; and 3) provide decision-makers and reviewers with a conceptual and graphical guide to identifying these key violations. Our overall goal is to help epidemiologists, policy-makers, journal editors, journalists, researchers, and other research consumers understand and weigh the strengths and limitations of evidence.


Subject(s)
COVID-19 , Health Policy , Bias , Humans , Interrupted Time Series Analysis , SARS-CoV-2
20.
Elife ; 102021 06 11.
Article in English | MEDLINE | ID: covidwho-1266916

ABSTRACT

In severe viral pneumonia, including Coronavirus disease 2019 (COVID-19), the viral replication phase is often followed by hyperinflammation, which can lead to acute respiratory distress syndrome, multi-organ failure, and death. We previously demonstrated that alpha-1 adrenergic receptor (⍺1-AR) antagonists can prevent hyperinflammation and death in mice. Here, we conducted retrospective analyses in two cohorts of patients with acute respiratory distress (ARD, n = 18,547) and three cohorts with pneumonia (n = 400,907). Federated across two ARD cohorts, we find that patients exposed to ⍺1-AR antagonists, as compared to unexposed patients, had a 34% relative risk reduction for mechanical ventilation and death (OR = 0.70, p = 0.021). We replicated these methods on three pneumonia cohorts, all with similar effects on both outcomes. All results were robust to sensitivity analyses. These results highlight the urgent need for prospective trials testing whether prophylactic use of ⍺1-AR antagonists ameliorates lower respiratory tract infection-associated hyperinflammation and death, as observed in COVID-19.


Subject(s)
Adrenergic alpha-1 Receptor Antagonists/therapeutic use , Pneumonia, Viral/drug therapy , Respiration, Artificial/statistics & numerical data , Respiratory Distress Syndrome/drug therapy , Aged , Aged, 80 and over , Doxazosin/therapeutic use , Humans , Male , Middle Aged , Pneumonia, Viral/mortality , Respiratory Distress Syndrome/mortality , Retrospective Studies , Sweden/epidemiology , Tamsulosin/therapeutic use , United States/epidemiology
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