Family-centred care for children with traumatic brain injury and/or spinal cord injury: a qualitative study of service provider perspectives during the COVID-19 pandemic

Objectives
COVID-19 has led to rapid changes in rehabilitation service provision for young people living with traumatic brain and/or spinal cord injury. The aim of this project was to understand the experiences of rehabilitation service providers during the acute response stage of the COVID-19 pandemic. Specifically, we aimed to identify innovative approaches to meeting the ongoing needs of young people with traumatic brain and/or spinal cord injury during this time.

Setting
This study was conducted at a research institute and involved remote interviews with key informants around Australia and internationally.

Participants
Key informants from 11 services supporting children and/or adolescents with traumatic brain injury and/or spinal cord injury were interviewed using a semistructured interview guide. Interviews were transcribed and analysed using inductive thematic analysis.

Results
Three key themes emerged: (1) recognising and responding to the experiences of families during the pandemic, (2) the impact of greater use of telehealth on care delivery, and (3) realising opportunities to enhance family-centred care.

Conclusions
These themes capture shifting perspectives and process changes relevant to longer term practice. Research findings suggest opportunities for future service development, enabling service delivery that is more family centred, flexible and efficient in meeting the needs of families. Understanding these experiences and the changed nature of service delivery provides important insights with implications for future service improvement.

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Giugno 2022

Multilevel determinants of racial/ethnic disparities in severe maternal morbidity and mortality in the context of the COVID-19 pandemic in the USA: protocol for a concurrent triangulation, mixed-methods study

Introduction
The COVID-19 pandemic has affected communities of colour the hardest. Non-Hispanic black and Hispanic pregnant women appear to have disproportionate SARS-CoV-2 infection and death rates.

Methods and analysis
We will use the socioecological framework and employ a concurrent triangulation, mixed-methods study design to achieve three specific aims: (1) examine the impacts of the COVID-19 pandemic on racial/ethnic disparities in severe maternal morbidity and mortality (SMMM); (2) explore how social contexts (eg, racial/ethnic residential segregation) have contributed to the widening of racial/ethnic disparities in SMMM during the pandemic and identify distinct mediating pathways through maternity care and mental health; and (3) determine the role of social contextual factors on racial/ethnic disparities in pregnancy-related morbidities using machine learning algorithms. We will leverage an existing South Carolina COVID-19 Cohort by creating a pregnancy cohort that links COVID-19 testing data, electronic health records (EHRs), vital records data, healthcare utilisation data and billing data for all births in South Carolina (SC) between 2018 and 2021 ( >200 000 births). We will also conduct similar analyses using EHR data from the National COVID-19 Cohort Collaborative including >270 000 women who had a childbirth between 2018 and 2021 in the USA. We will use a convergent parallel design which includes a quantitative analysis of data from the 2018–2021 SC Pregnancy Risk Assessment and Monitoring System (unweighted n >2000) and in-depth interviews of 40 postpartum women and 10 maternal care providers to identify distinct mediating pathways.

Ethics and dissemination
The study was approved by institutional review boards at the University of SC (Pro00115169) and the SC Department of Health and Environmental Control (DHEC IRB.21-030). Informed consent will be provided by the participants in the in-depth interviews. Study findings will be disseminated with key stakeholders including patients, presented at academic conferences and published in peer-reviewed journals.

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Giugno 2022

Impact of biological sex and gender-related factors on public engagement in protective health behaviours during the COVID-19 pandemic: cross-sectional analyses from a global survey

Objective
Given the role of sociocultural gender in shaping human behaviours, the main objective of this study was to examine whether sex and gender-related factors were associated with the public’s adherence to COVID-19-recommended protective health behaviours.

Design
This was a retrospective analysis of the survey that captured data on people’s awareness, attitudes and behaviours as they relate to the COVID-19 policies.

Setting
Data from the International COVID-19 Awareness and Responses Evaluation survey collected between March 2020 and February 2021 from 175 countries.

Participants
Convenience sample around the world.

Main outcome measures
We examined the role of sex and gender-related factors in relation to non-adherence of protective health behaviours including: (1) hand washing; (2) mask wearing; and (3) physical distancing. Multivariable logistic regression was conducted to determine the factors associated with non-adherence to behaviours.

Results
Among 48 668 respondents (mean age: 43 years; 71% female), 98.3% adopted hand washing, 68.5% mask wearing and 76.9% physical distancing. Compared with males, females were more likely to adopt hand washing (OR=1.97, 95% CI: 1.71 to 2.28) and maintain physical distancing (OR=1.28, 95% CI: 1.22 to 1.34). However, in multivariable sex-stratified models, females in countries with higher Gender Inequality Indexes (GII) were less likely to report hand washing (adjusted OR (aOR)=0.47, 95% CI: 0.21 to 1.05). Females who reported being employed (aOR=0.22, 95% CI: 0.10 to 0.48) and in countries with low/medium GIIs (aOR=0.18, 95% CI 0.06 to 0.51) were less likely to report mask wearing. Females who reported being employed were less likely to report physical distancing (aOR=0.39, 95% CI: 0.32 to 0.49).

Conclusion
While females showed greater adherence to COVID-19 protective health behaviours, gender-related factors, including employment status and high country-wide gender inequality, were independently associated with non-adherence. These findings may inform public health and vaccination policies in current as well as future pandemics.

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Giugno 2022

Preparedness for and impact of COVID-19 on primary health care delivery in urban and rural Malawi: a mixed methods study

Objective
Across Africa, the impact of COVID-19 continues to be acutely felt. This includes Malawi, where a key component of health service delivery to mitigate against COVID-19 are the primary healthcare facilities, strategically placed throughout districts to offer primary and maternal healthcare. These facilities have limited infrastructure and capacity but are the most accessible and play a crucial role in responding to the COVID-19 pandemic. This study assessed health facility preparedness for COVID-19 and the impact of the pandemic on health service delivery and frontline workers.

Setting
Primary and maternal healthcare in Blantyre District, Malawi.

Participants
We conducted regular visits to 31 healthcare facilities and a series of telephone-based qualitative interviews with frontline workers (n=81 with 38 participants) between August 2020 and May 2021.

Results
Despite significant financial and infrastructural constraints, health centres continued to remain open. The majority of frontline health workers received training and access to preventative COVID-19 materials. Nevertheless, we found disruptions to key services and a reduction in clients attending facilities. Key barriers to implementing COVID-19 prevention measures included periodic shortages of resources (soap, hand sanitiser, water, masks and staff). Frontline workers reported challenges in managing physical distancing and in handling suspected COVID-19 cases. We found discrepancies between reported behaviour and practice, particularly with consistent use of masks, despite being provided. Frontline workers felt COVID-19 had negatively impacted their lives. They experienced fatigue and stress due to heavy workloads, stigma in the community and worries about becoming infected with and transmitting COVID-19.

Conclusion
Resource (human and material) inadequacy shaped the health facility capacity for support and response to COVID-19, and frontline workers may require psychosocial support to manage the impacts of the COVID-19 pandemic.

Leggi
Giugno 2022

Nurturing care during COVID-19: a rapid review of early evidence

Objectives
The COVID-19 pandemic has brought significant changes to family life, society and essential health and other services. A rapid review of evidence was conducted to examine emerging evidence on the effects of the pandemic on three components of nurturing care, including responsive caregiving, early learning, and safety and security.

Design
Two academic databases, organisational websites and reference lists were searched for original studies published between 1 January and 25 October 2020. A single reviewer completed the study selection and data extraction with verification by a second reviewer.

Interventions
We included studies with a complete methodology and reporting on quantitative or qualitative evidence related to nurturing care during the pandemic.

Primary and secondary outcome measures
Studies reporting on outcomes related to responsive caregiving, early learning, and safety and security were included.

Results
The search yielded 4410 citations in total, and 112 studies from over 30 countries met our eligibility criteria. The early evidence base is weighted towards studies in high-income countries, studies related to caregiver mental health and those using quantitative survey designs. Studies reveal issues of concern related to increases in parent and caregiver stress and mental health difficulties during the pandemic, which was linked to harsher and less warm or responsive parenting in some studies. A relatively large number of studies examined child safety and security and indicate a reduction in maltreatment referrals. Lastly, studies suggest that fathers’ engagement in caregiving increased during the early phase of the pandemic, children’s outdoor play and physical activity decreased (while screen time increased), and emergency room visits for child injuries decreased.

Conclusion
The results highlight key evidence gaps (ie, breastfeeding support and opportunities for early learning) and suggest the need for increased support and evidence-based interventions to ensure young children and other caregivers are supported and protected during the pandemic.

Leggi
Giugno 2022

Are free school meals failing families? Exploring the relationship between child food insecurity, child mental health and free school meal status during COVID-19: national cross-sectional surveys

Objective
Food insecurity is linked to poor health and well-being in children and rising prevalence rates have been exacerbated by COVID-19. Free school meals (FSM) are considered a critical tool for reducing the adverse effects of poverty but apply a highly restrictive eligibility criteria. This study examined levels of food security and FSM status to support decision-making regarding increasing the current eligibility criteria.

Design
Two cross-sectional national surveys administered in August–September 2020 and January–February 2021 were used to examine the impact of COVID-19 on the food experiences of children and young people.

Setting
UK.

Participants
2166 children (aged 7–17 years) and parents/guardians.

Main outcome measures
Participant characteristics were described by food security and FSM status; estimated marginal means were calculated to obtain the probability of poor mental health, expressed as children reporting feeling stressed or worried in the past month, by food security status and FSM status.

Results
We observed food insecurity among both children who did and did not receive of FSM: 23% of children not receiving FSM were food insecure. Children who were food insecure had a higher probability of poor mental health (31%, 95% CI: 23%, 40%) than children who were food secure (10%, 95% CI: 7%, 14%). Food insecure children receiving FSM had a higher probability of poor mental health (51%, 95% CI: 37%, 65%) than those who were food insecure and not receiving FSM (29%, 95% CI: 19%, 42%).

Conclusion
Many children experienced food insecurity regardless of whether they received FSM, suggesting the eligibility criteria needs to be widened to prevent overlooking those in need.

Leggi
Giugno 2022

The impact of the COVID-19 pandemic on the research activity and working experience of clinical academics, with a focus on gender and ethnicity: a qualitative study in the UK

Objective
To investigate the impact of the COVID-19 pandemic on the research activity and working experience of clinical academics, with a focus on gender and ethnicity.

Design
Qualitative study based on interviews and audio/written diary data.

Setting
UK study within clinical academia.

Participants
Purposive sample of 82 clinical academics working in medicine and dentistry across all career stages ranging from academic clinical fellows and doctoral candidates to professors.

Methods
Qualitative semistructured interviews (n=68) and audio diary data (n=30; including 16 participants who were also interviewed) collected over an 8-month period (January–September 2020), thematically analysed.

Results
20 of 30 (66.6%) audio diary contributors and 40 of 68 (58.8%) interview participants were female. Of the participants who disclosed ethnicity, 5 of 29 (17.2%) audio diary contributors and 19/66 (28.8%) interview participants identified as Black, Asian or another minority (BAME). Four major themes were identified in relation to the initial impact of COVID-19 on clinical academics: opportunities, barriers, personal characteristics and social identity, and fears and uncertainty. COVID-19 presented opportunities for new avenues of research. Barriers included access to resources to conduct research and the increasing teaching demands. One of the most prominent subthemes within ‘personal characteristics’ was that of the perceived negative impact of the pandemic on the work of female clinical academics. This was attributed to inequalities experienced in relation to childcare provision and research capacity. Participants described differential experiences based upon their gender and ethnicity, noting intersectional identities.

Conclusions
While there have been some positives afforded to clinical academics, particularly for new avenues of research, COVID-19 has negatively impacted workload, future career intentions and mental health. BAME academics were particularly fearful due to the differential impact on health. Our study elucidates the direct and systemic discrimination that creates barriers to women’s career trajectories in clinical academia. A flexible, strategic response that supports clinical academics in resuming their training and research is required. Interventions are needed to mitigate the potential lasting impact on capacity from the pandemic, and the potential for the loss of women from this valuable workforce.

Leggi
Giugno 2022

Relationships among thriving at work, organisational commitment and job satisfaction among Chinese front-line primary public health workers during COVID-19 pandemic: a structural equation model analysis

Objectives
This study aims to explore the mediating effect and influence mechanism of organisational commitment on the association among thriving at work and job satisfaction among frontline primary public health workers (PHWs) in China during the COVID-19 pandemic.

Design
This study is a cross-sectional written survey.

Setting
We included 20 primary care units in northern provinces of China.

Participants
A total of 601 PHWs who worked in primary organisations and against COVID-19 on the front line were included.

Methods
We collected the data from the participants’ written questionnaire (Minnesota Satisfaction Questionnaire, thriving at work scale and organisational commitment scale), and programmed AMOS V.26.0 to develop a structural equation model (SEM) based on the relationships among the three variables.

Results
The thriving at work scores of the primary PHWs were (M=3.17, SD=0.65), and job satisfaction was (M=3.05, SD=0.69); the scores of their thriving at work, organisational commitment and job satisfaction were all significantly correlated (p

Leggi
Giugno 2022

I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations

Introduction
The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.

Methods and analysis
The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.

Ethics and dissemination
ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.

Trial registration number
NCT04488081.

Leggi
Giugno 2022

Early empiric anti-Mycobacterium tuberculosis therapy for sepsis in sub-Saharan Africa: a protocol of a randomised clinical trial

Introduction
Sub-Saharan Africa shoulders the highest burden of global sepsis and associated mortality. In high HIV and tuberculosis (TB) prevalent settings such as sub-Saharan Africa, TB is the leading cause of sepsis. However, anti-TB therapy is often delayed and may not achieve adequate blood concentrations in patients with sepsis. Accordingly, this multisite randomised clinical trial aims to determine whether immediate and/or increased dose anti-TB therapy improves 28-day mortality for participants with HIV and sepsis in Tanzania or Uganda.

Methods and analysis
This is a phase 3, multisite, open-label, randomised controlled clinical 2×2 factorial superiority trial of (1) immediate initiation of anti-TB therapy and (2) sepsis-specific dose anti-TB therapy in addition to standard of care antibacterials for adults with HIV and sepsis admitted to hospital in Tanzania or Uganda. The primary endpoint is 28-day mortality. A sample size of 436 participants will provide 80% power for testing each of the main effects of timing and dose on 28-day mortality with a two-sided significance level of 5%. The expected main effect for absolute risk reduction is 13% and the expected OR for risk reduction is 1.58.

Ethics and dissemination
This clinical trial will determine the optimal content, dosing and timing of antimicrobial therapy for sepsis in high HIV and TB prevalent settings. The study is funded by the National Institutes of Health in the US. Institutional review board approval was conferred by the University of Virginia, the Tanzania National Institute for Medical Research, and the Uganda National Council for Science and Technology. Study results will be published in peer-reviewed journals and in the popular press of Tanzania and Uganda. We will also present our findings to the Community Advisory Boards that we convened during study preparation.

Trial registration number
ClinicalTrials.gov (NCT04618198).

Leggi
Giugno 2022

Characteristics of nursing homes and early preventive measures associated with risk of infection from COVID-19 in Lazio region, Italy: a retrospective case-control study

Objectives
To understand which organisational–structural characteristics of nursing homes—also referred to as long-term care facilities (LTCFs)—and the preventative measures adopted in response to the pandemic are associated with the risk of a COVID-19 outbreak.

Setting
LTCFs in Lazio region in Italy.

Design
The study adopts a case–control design.

Participants
We included 141 facilities and 100 provided information for the study. Cases were defined as facilities reporting a COVID-19 outbreak (two or more cases) in March–December 2020; controls were defined as LTCFs reporting one case or zero. The exposures include the structural–organisational characteristics of the LTCFs as reported by the facilities, preventative measures employed and relevant external factors.

Results
Twenty facilities reported an outbreak of COVID-19. In binary logistic regression models, facilities with more than 15 beds were five times more likely to experience an outbreak than facilities with less than 15 beds OR=5.60 (CI 1.61 to 25.12; p value 0.002); admitting new residents to facilities was associated with a substantially higher risk of an outbreak: 6.46 (CI 1.58 to 27.58, p value 0.004). In a multivariable analysis, facility size was the only variable that was significantly associated with a COVID-19 outbreak OR= 5.37 (CI 1.58 to 22.8; p value 0.012) for larger facilities ( >15 beds) versus smaller (

Leggi
Giugno 2022

COVID-19 in the context of pregnancy, infancy and parenting (CoCoPIP) study: protocol for a longitudinal study of parental mental health, social interactions, physical growth and cognitive development of infants during the pandemic

Introduction
While the secondary impact of the COVID-19 pandemic on the psychological well-being of pregnant women and parents has become apparent over the past year, the impact of these changes on early social interactions, physical growth and cognitive development of their infants is unknown, as is the way in which a range of COVID-19-related changes have mediated this impact. This study (CoCoPIP) will investigate: (1) how parent’s experiences of the social, medical and financial changes during the pandemic have impacted prenatal and postnatal parental mental health and parent–infant social interaction; and (2) the extent to which these COVID-19-related changes in parental prenatal and postnatal mental health and social interaction are associated with fetal and infant development.

Methods and analysis
The CoCoPIP study is a national online survey initiated in July 2020. This ongoing study (n=1700 families currently enrolled as of 6 May 2021) involves both quantitative and qualitative data being collected across pregnancy and infancy. It is designed to identify the longitudinal impact of the pandemic from pregnancy to 2 years of age as assessed using a range of parent- and self-report measures, with the aim of identifying if stress-associated moderators (ie, loss of income, COVID-19 illness, access to ante/postnatal support) appear to impact parental mental health, and in turn, infant development. In addition, we aim to document individual differences in social and cognitive development in toddlers who were born during restrictions intended to mitigate COVID-19 spread (eg, social distancing, national lockdowns).

Ethics and dissemination
Ethical approval was given by the University of Cambridge, Psychology Research Ethics Committee (PRE.2020.077). Findings will be made available via community engagement, public forums (eg, social media,) and to national (eg, NHS England) and local (Cambridge Universities Hospitals NHS Foundation Trust) healthcare partners. Results will be submitted for publication in peer-reviews journals.

Leggi
Giugno 2022

Comparative-effectiveness research of COVID-19 treatment: a rapid scoping review

Objectives
The COVID-19 pandemic has stimulated growing research on treatment options. We aim to provide an overview of the characteristics of studies evaluating COVID-19 treatment.

Design
Rapid scoping review

Data sources
Medline, Embase and biorxiv/medrxiv from inception to 15 May 2021.

Setting
Hospital and community care.

Participants
COVID-19 patients of all ages.

Interventions
COVID-19 treatment.

Results
The literature search identified 616 relevant primary studies of which 188 were randomised controlled trials and 299 relevant evidence syntheses. The studies and evidence syntheses were conducted in 51 and 39 countries, respectively.
Most studies enrolled patients admitted to acute care hospitals (84%), included on average 169 participants, with an average age of 60 years, study duration of 28 days, number of effect outcomes of four and number of harm outcomes of one. The most common primary outcome was death (32%).
The included studies evaluated 214 treatment options. The most common treatments were tocilizumab (11%), hydroxychloroquine (9%) and convalescent plasma (7%). The most common therapeutic categories were non-steroidal immunosuppressants (18%), steroids (15%) and antivirals (14%). The most common therapeutic categories involving multiple drugs were antimalarials/antibiotics (16%), steroids/non-steroidal immunosuppressants (9%) and antimalarials/antivirals/antivirals (7%). The most common treatments evaluated in systematic reviews were hydroxychloroquine (11%), remdesivir (8%), tocilizumab (7%) and steroids (7%).
The evaluated treatment was in favour 50% and 36% of the evaluations, according to the conclusion of the authors of primary studies and evidence syntheses, respectively.

Conclusions
This rapid scoping review characterised a growing body of comparative-effectiveness primary studies and evidence syntheses. The results suggest future studies should focus on children, elderly ≥65 years of age, patients with mild symptoms, outpatient treatment, multimechanism therapies, harms and active comparators. The results also suggest that future living evidence synthesis and network meta-analysis would provide additional information for decision-makers on managing COVID-19.

Leggi
Giugno 2022