Design and analysis of outcomes following SARS-CoV-2 infection in veterans.

BACKGROUND: Understanding how SARS-CoV-2 infection impacts long-term patient outcomes requires identification of comparable persons with and without infection. We report the design and implementation of a matching strategy employed by the Department of Veterans Affairs' (VA) COVID-19 Observational Research Collaboratory (CORC) to develop comparable cohorts of SARS-CoV-2 infected and uninfected persons for the purpose of inferring potential causative long-term adverse effects of SARS-CoV-2 infection in the Veteran population. METHODS: In a retrospective cohort study, we identified VA health care system patients who were and were not infected with SARS-CoV-2 on a rolling monthly basis. We generated matched cohorts within each month utilizing a combination of exact and time-varying propensity score matching based on electronic health record (EHR)-derived covariates that can be confounders or risk factors across a range of outcomes. RESULTS: From an initial pool of 126,689,864 person-months of observation, we generated final matched cohorts of 208,536 Veterans infected between March 2020-April 2021 and 3,014,091 uninfected Veterans. Matched cohorts were well-balanced on all 39 covariates used in matching after excluding patients for: no VA health care utilization; implausible age, weight, or height; living outside of the 50 states or Washington, D.C.; prior SARS-CoV-2 diagnosis per Medicare claims; or lack of a suitable match. Most Veterans in the matched cohort were male (88.3%), non-Hispanic (87.1%), white (67.2%), and living in urban areas (71.5%), with a mean age of 60.6, BMI of 31.3, Gagne comorbidity score of 1.4 and a mean of 2.3 CDC high-risk conditions. The most common diagnoses were hypertension (61.4%), diabetes (34.3%), major depression (32.2%), coronary heart disease (28.5%), PTSD (25.5%), anxiety (22.5%), and chronic kidney disease (22.5%). CONCLUSION: This successful creation of matched SARS-CoV-2 infected and uninfected patient cohorts from the largest integrated health system in the United States will support cohort studies of outcomes derived from EHRs and sample selection for qualitative interviews and patient surveys. These studies will increase our understanding of the long-term outcomes of Veterans who were infected with SARS-CoV-2.

Caring for children in foster and kinship care during a pandemic: lessons learned and recommendations

Through qualitative feedback from professionals in healthcare, mental health, and child welfare, this study explored the impact of the COVID-19 pandemic on the health and well-being of children in the child welfare system. Positive outcomes and challenges related to the care of children in foster or kinship care in Texas during the COVID-19 pandemic are described. Themes identified included disparities in the child welfare system;utilization of telehealth;cross-sector communication and collaboration;safety considerations;and placement stability and support. The article concludes with recommendations in each of these areas for ensuring the health and well-being of children in foster and kinship care during a pandemic.

Consensus elements for observational research on COVID-19-related long-term outcomes.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its long-term outcomes may be jointly caused by a wide range of clinical, social, and economic characteristics. Studies aiming to identify mechanisms for SARS-CoV-2 morbidity and mortality must measure and account for these characteristics to arrive at unbiased, accurate conclusions. We sought to inform the design, measurement, and analysis of longitudinal studies of long-term outcomes among people infected with SARS-CoV-2. We fielded a survey to an interprofessional group of clinicians and scientists to identify factors associated with SARS-CoV-2 infection and subsequent outcomes. Using an iterative process, we refined the resulting list of factors into a consensus causal diagram relating infection and 12-month mortality. Finally, we operationalized concepts from the causal diagram into minimally sufficient adjustment sets using common medical record data elements. Total 31 investigators identified 49 potential risk factors for and 72 potential consequences of SARS-CoV-2 infection. Risk factors for infection with SARS-CoV-2 were grouped into five domains: demographics, physical health, mental health, personal social, and economic factors, and external social and economic factors. Consequences of coronavirus disease 2019 (COVID-19) were grouped into clinical consequences, social consequences, and economic consequences. Risk factors for SARS-CoV-2 infection were developed into a consensus directed acyclic graph for mortality that included two minimally sufficient adjustment sets. We present a collectively developed and iteratively refined list of data elements for observational research in SARS-CoV-2 infection and disease. By accounting for these elements, studies aimed at identifying causal pathways for long-term outcomes of SARS-CoV-2 infection can be made more informative.

Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era.

BACKGROUND: The effectiveness of a third mRNA COVID-19 vaccine dose (booster dose) against the Omicron (B.1.1.529) variant is uncertain, especially in older, high-risk populations. OBJECTIVE: To determine mRNA booster vaccine effectiveness (VE) against SARS-CoV-2 infection, hospitalization, and death in the Omicron era by booster type, primary vaccine type, time since primary vaccination, age, and comorbidity burden. DESIGN: Retrospective matched cohort study designed to emulate a target trial of booster vaccination versus no booster, conducted from 1 December 2021 to 31 March 2022. SETTING: U.S. Department of Veterans Affairs health care system. PARTICIPANTS: Persons who had received 2 mRNA COVID-19 vaccine doses at least 5 months earlier. INTERVENTION: Booster monovalent mRNA vaccination (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) versus no booster. MEASUREMENTS: Booster VE. RESULTS: Each group included 490 838 well-matched persons, who were predominantly male (88%), had a mean age of 63.0 years (SD, 14.0), and were followed for up to 121 days (mean, 79.8 days). Booster VE more than 10 days after a booster dose was 42.3% (95% CI, 40.6% to 43.9%) against SARS-CoV-2 infection, 53.3% (CI, 48.1% to 58.0%) against SARS-CoV-2-related hospitalization, and 79.1% (CI, 71.2% to 84.9%) against SARS-CoV-2-related death. Booster VE was similar for different booster types (BNT162b2 or mRNA-1273), age groups, and primary vaccination regimens but was significantly higher with longer time since primary vaccination and higher comorbidity burden. LIMITATION: Predominantly male population. CONCLUSION: Booster mRNA vaccination was highly effective in preventing death and moderately effective in preventing infection and hospitalization for up to 4 months after administration in the Omicron era. Increased uptake of booster vaccination, which is currently suboptimal, should be pursued to limit the morbidity and mortality of SARS-CoV-2 infection, especially in persons with high comorbidity burden. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.

Importance: Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice. Objective: To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach. Design, Setting, and Participants: This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022. Interventions: Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination. Main Outcomes and Measures: Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined. Results: The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver. Conclusions and Relevance: This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond. Trial Registration: ClinicalTrials.gov Identifier: NCT03520413.

Family Caregivers of Veterans Experience Clinically Significant Levels of Distress Prepandemic and During Pandemic: Implications for Caregiver Support Services.

BACKGROUND: Of the 26.4 million family caregivers in the United States, nearly 40% report high levels of emotional strain and subjective burden. However, for the 5 million caregivers of Veterans, little is known about the experiences of caregivers of Veterans during the coronavirus disease 2019 (COVID-19) pandemic. OBJECTIVE: The aim was to examine pandemic-related changes of caregiver well-being outcomes. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Using a pre/post design and longitudinal data of individual caregivers captured pre-COVID-19 and during COVID-19, we use multilevel generalized linear mixed models to examine pandemic-related changes to caregiver well-being (n=903). The primary outcome measures include Zarit Subjective Burden, Center for Epidemiologic Studies Short Depression Scale, perceived financial strain, life chaos, and loneliness. RESULTS: During the pandemic, we observe slight improvements for caregivers across well-being measures except for perceived financial strain. Before the pandemic, we observed that caregivers screened positive for clinically significant caregiver burden and probable depression. While we do not observe worsening indicators of caregiver well-being during the COVID-19 pandemic, the average predicted values of indicators of caregiver well-being remain clinically significant for caregiving subjective burden and depression. CONCLUSIONS: These findings illuminate pandemic-related impacts of caregivers receiving support through the Veterans Affairs (VA) pre-COVID and during the COVID-19 pandemic while caring for a population of frail, older care-recipients with a high burden of mental illness and other chronic conditions. Considering the long-term impacts of the pandemic to increase morbidity and the expected increased demand for caregivers in an aging population, these consistently high levels of distress despite receiving support highlight the need for interventions and policy reform to systematically support caregivers more broadly.

Maternity care during COVID-19: a qualitative evidence synthesis of women's and maternity care providers' views and experiences.

BACKGROUND: As COVID-19 continued to impact society and health, maternity care, as with many other healthcare sectors across the globe, experienced tumultuous changes. These changes have the potential to considerably impact on the experience of maternity care. To gain insight and understanding of the experience of maternity care during COVID-19, from the perspectives of women and maternity care providers, we undertook a qualitative evidence synthesis (QES). METHODS: The population of interest for the QES were pregnant and postpartum women, and maternity care providers, who provided qualitative data on their experiences of maternity care during COVID-19. The electronic databases of MEDLINE, CINAHL, EMBASE, PsycINFO and the Cochrane COVID study register were systematically searched from 01 Jan 2020 to 13 June 2021. The methodological quality of the included studies was appraised using a modified version of the quality assessment tool, based on 12-criteria, designed by the Evidence for Policy and Practice Information coordinating Centre (EPPI-Centre). Data were extracted by two reviewers independently and synthesised using the Thomas and Harden framework. Confidence in the findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual). RESULTS: Fifty records relating to 48 studies, involving 9,348 women and 2,538 maternity care providers, were included in the QES. The methodological quality of the studies varied from four studies meeting all 12 quality criteria to two studies meeting one quality criterion only. The synthesis revealed eight prominent themes. Five of these reflected women's experiences: 1) Altered maternity care (women), 2) COVID-related restrictions, 3) Infection prevention and risk, 4) 'the lived reality' - navigating support systems, and 5) Interactions with maternity services. Three themes reflected maternity care providers' experiences: 6) Altered maternity care (providers), 7) Professional and personal impact, and 8) Broader structural impact. Confidence in the findings was high or moderate. CONCLUSION: Although some positive experiences were identified, overall, this QES reveals that maternity care during COVID-19 was negatively experienced by both women and maternity care providers. The pandemic and associated changes evoked an array of emotive states for both populations, many of which have the potential to impact on future health and wellbeing. Resource and care planning to mitigate medium- and longer-term adverse sequelae are required. PROSPERO REGISTRATION: CRD42021232684.

Pittsburgh Air Pollution Changes During the COVID-19 Lockdown.

The rapid spread of COVID-19 resulted in various public lockdowns across the globe. Previous studies showed that resultant travel restrictions improved air quality. The novel results presented here focus on source-specific changes and compare air quality for multiple years controlled for precipitation. This study sought to analyze air pollution changes in Pittsburgh, a city where an industrial past and present has led to elevated levels of particulate matter with representative diameter of ≤ 2.5µm (PM2.5). Data from the Allegheny County Health Department, from monitors located near a variety of site types, were analyzed with generalized linear models that used a gamma distribution with a log link to determine the magnitude and significance of changes in air pollution during the COVID-19 lockdown. The hypothesis was that nitrogen dioxide (NO2), which is primarily linked to vehicular traffic, would decrease significantly while potential decreases in particulate matter (PM2.5 and PM10) would be less apparent. Results of the regression models showed that NO2 was significantly reduced during lockdown at both monitoring sites and that PM10 was also significantly reduced at the majority of monitoring sites. However, decreases in PM2.5 pollution were only observed at half of the monitoring locations, and the location which observed the greatest decreases is located adjacent to an industrial source. Decreases in PM2.5 at this monitoring site were likely a result of reduced industrial processes both dependent and independent of the COVID-19 lockdown. This study suggests that industrial sources are a larger contributor of particulate matter than vehicular transportation in the city of Pittsburgh and that future air pollution reduction efforts should focus attention on emission reduction at these industrial facilities.

COVID-19 and clinical outcomes of pregnancy: a comparative study

Background A series of changes in maternity care provision were implemented internationally in response to the COVID-19 pandemic. This study aimed to assess the impact of COVID-19 on maternal clinical outcomes, resulting from these changes to care provision. Methods A before and during comparative study of maternal pregnancy, childbirth, and postpartum clinical outcomes was conducted at a maternity hospital in Ireland. Inferential statistics were used to compare datasets with significance set at P<0.05. Results Overall, no difference in caesarean section rates between the two study periods was observed, although more caesarean sections were observed in multiparous women during the pandemic (30% vs 35%, P=0.01). The rate of elective compared to emergency caesarean section was also higher during the pandemic, from a proportionate difference of 3.6% pre-pandemic to 13.6% during the pandemic. Rates of induction of labour for post-dates (post-maturity induction) were also increased during the pandemic. Conclusions The changes to maternity care because of the COVID-19 pandemic appear to have affected some maternal clinical outcomes, and thus, potentially, women's overall intrapartum and postnatal health and wellbeing. [ABSTRACT FROM AUTHOR] Copyright of British Journal of Midwifery is the property of Mark Allen Holdings Limited and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Maternity care during COVID-19: a protocol for a qualitative evidence synthesis of women's and maternity care providers' views and experiences.

Background: Considerable changes in maternity care provision internationally were implemented in response to COVID-19. Such changes, often occurring suddenly with little advance warning, have had the potential to affect women's and maternity care providers experience of maternity care, both positively and negatively. For this reason, to gain insight and understanding of personal and professional experiences, we will perform a synthesis of the available qualitative evidence on women and maternity care providers' views and experiences of maternity care during COVID-19. Methods and analysis: A qualitative evidence synthesis will be conducted. Studies will be eligible if they include pregnant or postpartum women (up to six months) and maternity care providers who received or provided care during COVID-19. To retrieve relevant literature the electronic databases of CINAHL, EMBASE, MEDLINE, PsycINFO, and the Cochrane COVID study register ( https://covid-19.cochrane.org/) will be searched from 01-Jan-2020 to date of search. A combination of search terms based on COVID-19, pregnancy, childbirth and maternity care, and study design, will be used to guide the search.  The methodological quality of the included studies will be assessed by at least two reviewers using the Evidence for Policy and Practice Information (EPPI)-Centre 12-criteria quality assessment tool. The Thomas and Harden approach to thematic synthesis will be used for data synthesis. This will involve line by line coding of extracted data, establishing descriptive themes, and determining analytical themes. Confidence in the findings of the review will be assessed by two reviewers independently using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual).   Conclusion: The proposed synthesis of evidence will help identify maternity care needs during a global pandemic from the perspectives of those receiving and providing care. The evidence will inform and help enhance care provision into the future.

Women's views and experiences of maternity care during COVID-19 in Ireland: A qualitative descriptive study.

OBJECTIVE: To gain insight and understanding of women's views and experiences of maternity care during the COVID-19 pandemic in Ireland. DESIGN: A qualitative descriptive study using semi-structured interviews. Due to social distancing and associated COVID-19 restrictions at the time of the study, the interviews were held remotely via telephone. The interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to analyse the interview data. SETTING & PARTICIPANTS: A large urban tertiary referral maternity unit (greater than 8000 births per year) in the Republic of Ireland. Women of low and high obstetric risk, primiparous and multiparous, who gave birth in April or May of 2020 were eligible for inclusion. Women were invited to take part via a hospital-based gatekeeper who had no other involvement in the study. FINDINGS: Nineteen women consented to take part and were interviewed. Four dominant themes reflective of women's views and experiences emerged during data analysis. These were: 'navigating the system', 'at the end of the day it's just you', 'preparing for and adapting to uncertainty' and 'blessing in disguise'. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Women experienced added challenges as a result of COVID-19 associated altered care structures and processes. Some changes implemented in response to the pandemic were positively experienced by women. The findings will contribute to and assist in planning future services for women and their partners, and in tailoring care to meet women's expectations and needs as the COVID-19 pandemic continues and beyond.

State variation in effects of state social distancing policies on COVID-19 cases.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) sickened over 20 million residents in the United States (US) by January 2021. Our objective was to describe state variation in the effect of initial social distancing policies and non-essential business (NEB) closure on infection rates early in 2020. METHODS: We used an interrupted time series study design to estimate the total effect of all state social distancing orders, including NEB closure, shelter-in-place, and stay-at-home orders, on cumulative COVID-19 cases for each state. Data included the daily number of COVID-19 cases and deaths for all 50 states and Washington, DC from the New York Times database (January 21 to May 7, 2020). We predicted cumulative daily cases and deaths using a generalized linear model with a negative binomial distribution and a log link for two models. RESULTS: Social distancing was associated with a 15.4% daily reduction (Relative Risk = 0.846; Confidence Interval [CI] = 0.832, 0.859) in COVID-19 cases. After 3 weeks, social distancing prevented nearly 33 million cases nationwide, with about half (16.5 million) of those prevented cases among residents of the Mid-Atlantic census division (New York, New Jersey, Pennsylvania). Eleven states prevented more than 10,000 cases per 100,000 residents within 3 weeks. CONCLUSIONS: The effect of social distancing on the infection rate of COVID-19 in the US varied substantially across states, and effects were largest in states with highest community spread.

Care bundles for improving outcomes in patients with COVID-19 or related conditions in intensive care - a rapid scoping review.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the strain of coronavirus that causes coronavirus disease 2019 (COVID-19) can cause serious illness in some people resulting in admission to intensive care units (ICU) and frequently, ventilatory support for acute respiratory failure. Evaluating ICU care, and what is effective in improving outcomes for these patients is critical. Care bundles, a small set of evidence-based interventions, delivered together consistently, may improve patient outcomes. To identify the extent of the available evidence on the use of care bundles in patients with COVID-19 in the ICU, the World Health Organization (WHO) commissioned a scoping review to inform WHO guideline discussions. This review does not assess the effectiveness of the findings, assess risk of bias, or assess the certainty of the evidence (GRADE). As this review was commissioned to inform guideline discussions, it was done rapidly over a three-week period from 26 October to 18 November 2020. OBJECTIVES: To identify and describe the available evidence on the use of care bundles in the ICU for patients with COVID-19 or related conditions (acute respiratory distress syndrome (ARDS) viral pneumonia or pneumonitis), or both. In carrying out the review the focus was on characterising the evidence base and not evaluating the effectiveness or safety of the care bundles or their component parts. SEARCH METHODS: We searched MEDLINE, Embase, the Cochrane Library (CENTRAL and the Cochrane COVID-19 Study Register) and the WHO International Clinical Trials Registry Platform on 26 October 2020. SELECTION CRITERIA: Studies of all designs that reported on patients who are critically ill with COVID-19, ARDS, viral pneumonia or pneumonitis, in the ICU setting, where a care bundle was implemented in providing care, were eligible for inclusion. One review author (VS) screened all records on title and abstract. A second review author (DR) checked 20% of excluded and included records; agreement was 99.4% and 100% respectively on exclude/include decisions. Two review authors (VS and DR) independently screened all records at full-text level. VS and DR resolved any disagreements through discussion and consensus, or referral to a third review author (AN) as required. DATA COLLECTION AND ANALYSIS: One review author (VS) extracted the data and a second review author (DR) checked 20% of this for accuracy. As the review was not designed to synthesise effectiveness data, assess risk of bias, or characterise the certainty of the evidence (GRADE), we mapped the extracted data and presented them in tabular format based on the patient condition; that is patients with confirmed or suspected COVID-19, patients with ARDS, patients with any influenza or viral pneumonia, patients with severe respiratory failure, and patients with mixed conditions. We have also provided a narrative summary of the findings from the included studies. MAIN RESULTS: We included 21 studies and identified three ongoing studies. The studies were of variable designs and included a systematic review of standardised approaches to caring for critically ill patients in ICU, including but not exclusive to care bundles (1 study), a randomised trial (1 study), prospective and retrospective cohort studies (4 studies), before and after studies (7 studies), observational quality improvement reports (4 studies), case series/case reports (3 studies) and audit (1 study). The studies were conducted in eight countries, most commonly China (5 studies) and the USA (4 studies), were published between 1999 and 2020, and involved over 2000 participants in total. Studies categorised participant conditions patients with confirmed or suspected COVID-19 (7 studies), patients with ARDS (7 studies), patients with another influenza or viral pneumonia (5 studies), patients with severe respiratory failure (1 study), and patients with mixed conditions (1 study). The care bundles described in the studies involved multiple diverse practices. Guidance on ventilator settings (10 studies), restrictive fluid management (8 studies), sedation (7 studies) and prone positioning (7 studies) were identified most frequently, while only one study mentioned chest X-ray. None of the included studies reported the prespecified outcomes ICU-acquired weakness (muscle wasting, weight loss) and users' experience adapting care bundles. Of the remaining prespecified outcomes, 14 studies reported death in ICU, nine reported days of ventilation (or ventilator-free days), nine reported length of stay in ICU in days, five reported death in hospital, three reported length of stay in hospital in days, and three reported adherence to the bundle. AUTHORS' CONCLUSIONS: This scoping review has identified 21 studies on care bundle use in critically ill patients in ICU with COVID-19, ARDS, viral influenza or pneumonia and severe respiratory failure. The data for patients with COVID-19 specifically are limited, derived mainly from observational quality improvement or clinical experiential accounts. Research is required, urgently, to further assess care bundle use and optimal components of these bundles in this patient cohort. The care bundles described were also varied, with guidance on ventilator settings described in 10 care bundles, while chest X-ray was part mentioned in one care bundle in one study only. None of the studies identified in this scoping review measured users' experience of adapting care bundles. Optimising care bundle implementation requires that the components of the care bundle are collectively and consistently applied. Data on challenges, barriers and facilitators to implementation are needed. A formal synthesis of the outcome data presented in this review and a critical appraisal of the evidence is required by a subsequent effectiveness review. This subsequent review should further explore effect estimates across the included studies.

Correction to: Comparing Associations of State Reopening Strategies with COVID-19 Burden.

In the original version of this paper, an author was misidentified. The corrected author listing appears here, and has been updated in the online version.

Comparing Associations of State Reopening Strategies with COVID-19 Burden.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) infected over 5 million United States (US) residents resulting in more than 180,000 deaths by August 2020. To mitigate transmission, most states ordered shelter-in-place orders in March and reopening strategies varied. OBJECTIVE: To estimate excess COVID-19 cases and deaths after reopening compared with trends prior to reopening for two groups of states: (1) states with an evidence-based reopening strategy, defined as reopening indoor dining after implementing a statewide mask mandate, and (2) states reopening indoor dining rooms before implementing a statewide mask mandate. DESIGN: Interrupted time series quasi-experimental study design applied to publicly available secondary data. PARTICIPANTS: Fifty United States and the District of Columbia. INTERVENTIONS: Reopening indoor dining rooms before or after implementing a statewide mask mandate. MAIN MEASURES: Outcomes included daily cumulative COVID-19 cases and deaths for each state. KEY RESULTS: On average, the number of excess cases per 100,000 residents in states reopening without masks is ten times the number in states reopening with masks after 8 weeks (643.1 cases; 95% confidence interval (CI) = 406.9, 879.2 and 62.9 cases; CI = 12.6, 113.1, respectively). Excess cases after 6 weeks could have been reduced by 90% from 576,371 to 63,062 and excess deaths reduced by 80% from 22,851 to 4858 had states implemented mask mandates prior to reopening. Over 50,000 excess deaths were prevented within 6 weeks in 13 states that implemented mask mandates prior to reopening. CONCLUSIONS: Additional mitigation measures such as mask use counteract the potential growth in COVID-19 cases and deaths due to reopening businesses. This study contributes to the growing evidence that mask usage is essential for mitigating community transmission of COVID-19. States should delay further reopening until mask mandates are fully implemented, and enforcement by local businesses will be critical for preventing potential future closures.