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

Por: Files · D. C. · Matthay · M. A. · Calfee · C. S. · Aggarwal · N. R. · Asare · A. L. · Beitler · J. R. · Berger · P. A. · Burnham · E. L. · Cimino · G. · Coleman · M. H. · Crippa · A. · Discacciati · A. · Gandotra · S. · Gibbs · K. W. · Henderson · P. T. · Ittner · C. A. G. · Jauregui
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.

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

Por: Orlando · S. · Mazhari · T. · Abbondanzieri · A. · Cerone · G. · Ciccacci · F. · Liotta · G. · Mancinelli · S. · Marazzi · M. C. · Palombi · L.
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 (

Conclusion

There was evidence of a higher risk of COVID-19 in larger facilities and when new patients were admitted during the pandemic. All other structural–organisational characteristics and preventative measures were not associated with an outbreak. This finding calls into question existing policies, especially where there is a risk of harm to residents. One such example is the restriction of visitor access to facilities, resulting in the social isolation of residents.

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

Por: Aydin · E. · Weiss · S. M. · Glasgow · K. A. · Barlow · J. · Austin · T. · Johnson · M. H. · Lloyd-Fox · S.
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.

Risk of SARS-CoV-2 infection among front-line healthcare workers in Northeast Brazil: a respondent-driven sampling approach

Objectives

We assessed the prevalence of SARS-CoV-2 infection, personal protective equipment (PPE) shortages and occurrence of biological accidents among front-line healthcare workers (HCW).

Design, setting and participants

Using respondent-driven sampling, the study recruited distinct categories of HCW attending suspected or confirmed patients with COVID-19 from May 2020 to February 2021, in the Recife metropolitan area, Northeast Brazil.

Outcome measures

The criterion to assess SARS-CoV-2 infection among HCW was a positive self-reported PCR test.

Results

We analysed 1525 HCW: 527 physicians, 471 registered nurses, 263 nursing assistants and 264 physical therapists. Women predominated in all categories (81.1%; 95% CI: 77.8% to 84.1%). Nurses were older with more comorbidities (hypertension and overweight/obesity) than the other staff. The overall prevalence of SARS-CoV-2 infection was 61.8% (95% CI: 55.7% to 67.5%) after adjustment for the cluster random effect, weighted by network, and the reference population size. Risk factors for a positive RT-PCR test were being a nursing assistant (OR adjusted: 2.56; 95% CI: 1.42 to 4.61), not always using all recommended PPE while assisting patients with COVID-19 (OR adj: 2.15; 95% CI: 1.02 to 4.53) and reporting a splash of biological fluid/respiratory secretion in the eyes (OR adj: 3.37; 95% CI: 1.10 to 10.34).

Conclusions

This study shows the high frequency of SARS-CoV2 infection among HCW presumably due to workplace exposures. In our setting, nursing assistant comprised the most vulnerable category. Our findings highlight the need for improving healthcare facility environments, specific training and supervision to cope with public health emergencies.

Perspectives, benefits and challenges of a live OSCE during the COVID-19 pandemic in a cross-sectional study

Por: Loda · T. · Erschens · R. S. · Nevins · A. B. · Zipfel · S. · Herrmann-Werner · A.
Objectives

Restrictions due to the COVID-19 pandemic mandated fundamental changes to student evaluations, including the administration of the observed structured clinical examination (OSCE). This study aims to conduct an in-person OSCE to verify students’ practical skills under necessary infection control practices and the impact of face masks on student–patient interactions.

Design

Cross-sectional design.

Setting

The OSCE at Medical School of Tuebingen takes place in October 2020.

Participants

A total of 149 students (third year of study) completed the survey (RR=80.1%). It was their first OSCE.

Primary and secondary outcome measures

Primary outcome measure was how this type of OSCE was evaluated by participating students in regard to preparation, content and difficulty as well as in real life. Secondary outcome measures were how the implemented hygiene actions influenced the OSCE, including the interaction and communication between students and standardised patients (SPs). Items were rated on a 6-point Likert scale (1=completely to 6=not at all). Means, SDs, frequencies and percentages were calculated.

Results

149 students, 32 SPs and 59 examiners participated. The students rated the OSCE with 2.37 (±0.52) for preparation and 2.07 (±0.32) for content. They perceived the interaction to be significantly disrupted by the use of face masks (3.03±1.54) (p

Conclusions

An in-person OSCE, even in the midst of a global pandemic, is feasible and acceptable to both students and faculty. When compared the students’ results to previous students’ results who completed the OSCE before the pandemic, the results indicated that students felt less prepared than under non-pandemic circumstances; however, their performances on this OSCE were not lower.

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

Por: Pham · B. · Rios · P. · Radhakrishnan · A. · Darvesh · N. · Antony · J. · Williams · C. · Ramkissoon · N. · Cormack · G. V. · Grossman · M. R. · Kampman · M. · Patel · M. · Yazdi · F. · Robson · R. · Ghassemi · M. · Macdonald · E. · Warren · R. · Muller · M. P. · Straus · S. E. · Tricco · A
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.

Behavioral factors associated with SARS-CoV-2 infection

Por: Cajar · M. D. · Tan · F. C. C. · Boisen · M. K. · Krog · S. M. · Nolsoee · R. · Collatz Christensen · H. · Andersen · M. P. · Moeller · A. L. · Gerds · T. A. · Pedersen-Bjergaard · U. · Lindegaard · B. · Kristensen · P. L. · Christensen · T. B. · Torp-Pedersen · C. · Lendorf · M. E.
Objective

To study the association between behavioural factors and incidence rates of SARS-CoV-2 infection.

Design

Case–control web-based questionnaire study.

Setting

Questionnaire data were collected in the Capital Region of Denmark in December 2020 when limited restrictions were in place, while the number of daily SARS-CoV-2 cases increased rapidly.

Participants

8913 cases of laboratory-confirmed SARS-CoV-2 infection were compared with two groups of controls: (1) 34 063 individuals with a negative SARS-CoV-2 test from the same date (negative controls, NCs) and 2) 25 989 individuals who had never been tested for a SARS-CoV-2 infection (untested controls, UC). Controls were matched on sex, age, test date and municipality.

Exposure

Activities during the 14 days prior to being tested positive for SARS-CoV-2 or during the same period for matched controls and precautions taken during the entire pandemic.

Main outcomes and measures

SARS-CoV-2 infection incidence rate ratios (IRR).

Results

Response rate was 41.4% (n=93 121). Using public transportation, grocery shopping (IRR: NC: 0.52; UC: 0.63) and outdoor sports activities (NC: 0.75; UC: 0.96) were not associated with increased rate of SARS-CoV-2 infection. Most precautions, for example, using hand sanitizer (NC: 0.79; UC: 0.98), physical distancing (NC: 0.79; UC: 0.82) and avoiding handshakes (NC: 0.74; UC: 0.77), were associated with a lower rate of infection. Activities associated with many close contacts, especially indoors, increased rate of infection. Except for working from home, all types of occupation were linked to increased rate of infection.

Conclusions

In a community setting with moderate restrictions, activities such as using public transportation and grocery shopping with the relevant precautions were not associated with an increased rate of SARS-CoV-2 infection. Exposures and activities where safety measures are difficult to maintain might be important risk factors for infection. These findings may help public health authorities tailor their strategies for limiting the spread of SARS-CoV-2.

Impact of the COVID-19 pandemic on utilisation of facility-based essential maternal and child health services from March to August 2020 compared with pre-pandemic March-August 2019: a mixed-methods study in North Shewa Zone, Ethiopia

Por: Bekele · C. · Bekele · D. · Hunegnaw · B. M. · Van Wickle · K. · Gebremeskel · F. A. · Korte · M. · Tedijanto · C. · Taddesse · L. · Chan · G. J.
Introduction

Health systems are often weakened by public health emergencies that make it harder to access health services. We aimed to assess maternal, newborn and child health (MNCH) service utilisation during the first 6 months of the COVID-19 pandemic compared with prior to the pandemic.

Methods

We conducted a mixed study design in eight health facilities that are part of the Birhan field site in Amhara, Ethiopia and compared the trend of service utilisation in the first 6 months of COVID-19 with the corresponding time and data points of the preceding year.

Result

New family planning visits (43.2 to 28.5/month, p=0.014) and sick under 5 child visits (225.0 to 139.8/month, p=0.007) declined over the first 6 months of the pandemic compared with the same period in the preceding year. Antenatal (208.9 to 181.7/month, p=0.433) and postnatal care (26.6 to 19.8/month, p=0.155) visits, facility delivery rates (90.7 to 84.2/month, p=0.776), and family planning visits (313.3 to 273.4/month, p=0.415) declined, although this did not reach statistical significance. Routine immunisation visits (37.0 to 36.8/month, p=0.982) for children were maintained. Interviews with healthcare providers and clients highlighted several barriers to service utilisation during COVID-19, including fear of disease transmission, economic hardship, and transport service disruptions and restrictions. Enablers of service utilisation included communities’ decreased fear of COVID-19 and awareness-raising activities.

Conclusion

We observed a decline in essential MNCH services particularly in sick children and new family planning visits. To improve the resiliency of fragile health systems, resources are needed to continuously monitor service utilisation and clients’ evolving concerns during public health emergencies.

Protocol and clinical characteristics of patients under 'at-home care for COVID-19 in South Korea: a retrospective cohort study

Por: Park · J. J. · Seo · Y. B. · Lee · J. · Na · S. H. · Choi · Y. K.
Objective

As the number of patients with COVID-19 increased, at-home care was introduced for the first time in South Korea. This study aimed to analyse the characteristics and outcomes of patients who were treated under at-home care.

Design, setting and participants

This retrospective cohort study targeted patients under at-home care for COVID-19 in Yeongdeungpo-gu in Seoul, Korea, from 18 October 2021 to 12 December 2021. The public health centre selected eligible patients for at-home care and registered with our institution. Nurses monitored patients, and doctors decided to transfer healthcare facilities and release the quarantined patients according to their symptoms.

Outcome measures

Patient characteristics during the course of at-home care.

Results

A total of 1422 patients were enrolled and 9574 patient-days were managed. Most patients were aged ≥60 years (22.7% (n=323)), and 82.8% did not have underlying conditions. The median length of care for patients was 8 days (IQR: 5–10 days). During the study period, 986 (69.3%) patients were released from quarantine, 82 (5.8%) patients were transferred to facilities and 354 (24.9%) patients were still under at-home care at the end of the study period. The most common cause of transfer was sustained fever (n=30; 36.6%), followed by dyspnoea and desaturation (n=17; 20.7%). Factors associated with transfer were diabetes (OR: 3.591, 95% CI 1.488 to 8.665, p=0.004), pregnancy (OR: 5.839, 95% CI 1.035 to 32.935, p=0.046) and being presymptomatic at diagnosis (OR: 4.015, 95% CI 1.559 to 10.337, p=0.004).

Conclusions

There were no specific problems related to patient safety when operating at-home care. Patients with risk factors, such as diabetes, were more likely to be transferred to healthcare facilities. For safe at-home care, it is necessary to prepare for an appropriate response to the emergency.

Changes in household food security, access to health services and income in northern Lao PDR during the COVID-19 pandemic: a cross-sectional survey

Por: Head · J. R. · Chanthavilay · P. · Catton · H. · Vongsitthi · A. · Khamphouxay · K. · Simphaly · N.
Objectives

We assessed the relative difficulty in meeting food needs during the COVID-19 pandemic compared with before; determined the relationship between pandemic-associated difficulties in food access and household, maternal and child food security; and identified resiliency-promoting strategies.

Design

A cross-sectional survey of households undertaken in November 2020.

Setting

Rural districts of Luang Prabang Province, Lao People’s Democratic Republic.

Participants

Households (N=1122) with children under 5 years.

Primary and secondary outcomes measured

Survey respondents reported the relative ease of access of food and healthcare as well as changes in income and expenditures compared with before March 2020. We determined indicators of food security and source of foods consumed for households, women and children, as well as prevalence of malnutrition in children under 5.

Results

Nearly four-fifths (78.5%) found it harder to meet household food needs during the pandemic. The most common reasons were increased food prices (51.2%), loss of income (45.3%) and decreased food availability (36.6%). Adjusting for demographics, households with increased difficulty meeting food needs had lower food consumption scores and child dietary diversity. Over 85% of households lost income during the pandemic. Decreased expenditures was associated with reliance on more extreme coping strategies to meet food needs. The households who experienced no change in meeting food needs produced a greater percentage of their food from homegrown methods (4.22% more, 95% CI 1.28 to 7.15), than households who found it more difficult.

Conclusions

Pandemic-associated shocks may have large effects on food insecurity. Action is needed to mitigate consequences of the pandemic on nutrition. Local food production and safety net programmes that offset income losses may help.

Intention to vaccinate against COVID-19 and adherence to non-pharmaceutical interventions against COVID-19 prior to the second wave of the pandemic in Uganda: a cross-sectional study

Por: Wafula · S. T. · Mugume · I. B. · Sensasi · B. · Okware · S. · Chimbaru · A. · Nanyunja · M. · Talisuna · A. · Kabanda · R. · Bakyaita · T. · Wanyenze · R. K. · Byakika-Tusiime · J.
Objectives

The resurgence in cases and deaths due to COVID-19 in many countries suggests complacency in adhering to COVID-19 preventive guidelines. Vaccination, therefore, remains a key intervention in mitigating the impact of the COVID-19 pandemic. This study investigated the level of adherence to COVID-19 preventive measures and intention to receive the COVID-19 vaccine among Ugandans.

Design, setting and participants

A nationwide cross-sectional survey of 1053 Ugandan adults was conducted in March 2021 using telephone interviews.

Main outcome measures

Participants reported on adherence to COVID-19 preventive measures and intention to be vaccinated with COVID-19 vaccines.

Results

Overall, 10.2% of the respondents adhered to the COVID-19 preventive guidelines and 57.8% stated definite intention to receive a SARS-CoV-2 vaccine. Compared with women, men were less likely to adhere to COVID-19 guidelines (Odds Ratio (OR)=0.64, 95% CI 0.41 to 0.99). Participants from the northern (4.0%, OR=0.28, 95% CI 0.12 to 0.92), western (5.1%, OR=0.30, 95% CI 0.14 to 0.65) and eastern regions (6.5%, OR=0.47, 95% CI 0.24 to 0.92), respectively, had lower odds of adhering to the COVID-19 guidelines than those from the central region (14.7%). A higher monthly income of ≥US$137 (OR=2.31, 95% CI 1.14 to 4.58) and a history of chronic disease (OR=1.81, 95% CI 1.14 to 2.86) were predictors of adherence. Concerns about the chances of getting COVID-19 in the future (Prevalence Ratio (PR)=1.26, 95% CI 1.06 to 1.48) and fear of severe COVID-19 infection (PR=1.20, 95% CI 1.04 to 1.38) were the strongest predictors for a definite intention, while concerns for side effects were negatively associated with vaccination intent (PR=0.75, 95% CI 0.68 to 0.83).

Conclusion

Behaviour change programmes need to be strengthened to promote adherence to COVID-19 preventive guidelines as vaccination is rolled out as another preventive measure. Dissemination of accurate, safe and efficacious information about the vaccines is necessary to enhance vaccine uptake.

Charming e-cigarette users with distorted science: a survey examining social media platform use, nicotine-related misinformation and attitudes towards the tobacco industry

Por: Silver · N. A. · Kierstead · E. C. · Briggs · J. · Schillo · B.
Objective

To examine the role of social media in promoting recall and belief of distorted science about nicotine and COVID-19 and whether recall and belief predict tobacco industry beliefs.

Design

Young adults aged 18–34 years (N=1225) were surveyed cross-sectionally via online Qualtrics panel. The survey assessed recall and belief in three claims about nicotine and COVID-19 and three about nicotine in general followed by assessments of industry beliefs and use of social media. Ordinal logistic regression with robust standard errors controlling for gender, race/ethnicity, education, current e-cigarette use and age was used to examine relationships between variables.

Results

Twitter use was associated with higher odds of recall (OR=1.21, 95% CI=1.01 to 1.44) and belief (OR=1.26, 95% CI=1.04 to 1.52) in COVID-19-specific distorted science. YouTube use was associated with higher odds of believing COVID-19-specific distorted science (OR=1.32, 95% CI=1.09 to 1.60). Reddit use was associated with lower odds of believing COVID-19-specific distorted science (OR=0.72, 95% CI=0.59 to 0.88). Recall (OR=1.26, 95% CI=1.07 to 1.47) and belief (OR=1.28, 95% CI=1.09 to 1.50) in distorted science about nicotine in general as well as belief in distorted science specific to COVID-19 (OR=1.61, 95% CI=1.34 to 1.95) were associated with more positive beliefs about the tobacco industry. Belief in distorted science about nicotine in general was also associated with more negative beliefs about the tobacco industry (OR=1.18, 95% CI=1.02 to 1.35).

Conclusions

Use of social media platforms may help to both spread and dispel distorted science about nicotine. Addressing distorted science about nicotine is important, as it appears to be associated with more favourable views of the tobacco industry which may erode public support for effective regulation.

COVID-19 vaccine misinformation in English-language news media: retrospective cohort study

Por: Lurie · P. · Adams · J. · Lynas · M. · Stockert · K. · Carlyle · R. C. · Pisani · A. · Evanega · S. D.
Objectives

To describe COVID-19 vaccine misinformation and track trends over time in traditional news media.

Design

Retrospective cohort study of a large database of online articles, July 2020–June 2021.

Setting

English-language articles from 100 news outlets with the greatest reach.

Main outcome measures

Numbers and percentages of articles containing COVID-19 vaccine misinformation over the study period. Further analysis by misinformation themes and whether articles included primary misinformation, fact-checking or simply referred to misinformation.

Results

41 718 (3.2% of all COVID-19 vaccine articles) contained at least one of the vaccine misinformation themes based on the Boolean string developed for this study. The volume of such articles increased beginning in November 2020, but their percentage of all articles remained essentially stable after October 2020. 56.2% contained at least one mention of a safety theme, followed by development, production, and distribution (26.6%), and conspiracies (15.1%). Of 500 articles through January 2021 randomly selected from those identified by the Boolean string, 223 were not relevant, and 277 included either fact-checking (175 articles), refers to misinformation (87 articles) or primary misinformation (15 articles). In eight study weeks, the reach of these 277 articles (defined as visitors to the sites containing the articles) exceeded 250 million people. Fact-checking accounted for 69.6% of all reach for these articles and the number of such articles increased after November 2020. Overall, approximately 0.1% (95% CI 0.05% to 0.16%) of all articles on COVID-19 vaccines in our sample contained primary misinformation.

Conclusions

COVID-19 vaccine misinformation in traditional news media is uncommon but has the capacity to reach large numbers of readers and affect the vaccine conversation. Recent increases in fact-checking may counteract some of the misinformation currently circulating.

COVID-19 among staff and their family members of a healthcare research institution in Bangladesh between March 2020 and April 2021: a test-negative case-control study

Por: Mahfuz · M. · Alam · M. A. · Fahim · S. M. · Hasan · S. M. T. · Sarmin · M. · Das · S. · Mostafa · I. · Parveen · S. · Rahman · M. · Arifeen · S. E. · Clemens · J. D. · Ahmed · T.
Objective

To identify factors associated with COVID-19 positivity among staff and their family members of icddr,b, a health research institute located in Bangladesh.

Setting

Dhaka, Bangladesh.

Participants

A total of 4295 symptomatic people were tested for SARS-CoV-2 by reverse-transcription PCR between 19 March 2020 and 15 April 2021. Multivariable logistic regression was done to identify the factors associated with COVID-19 positivity by contrasting test positives with test negatives.

Result

Forty-three per cent of the participants were tested positive for SARS-CoV-2. The median age was high in positive cases (37 years vs 34 years). Among the positive cases, 97% were recovered, 2.1% had reinfections, 24 died and 41 were active cases as of 15 April 2021. Multivariable regression analysis showed that age more than 60 years (adjusted OR (aOR)=2.1, 95% CI 1.3 to 3.3; p

Conclusions

The study findings suggest that older age, fever, cough and anosmia were associated with COVID-19 among the study participants.

Evaluating the governance and preparedness of the Lebanese health system for the COVID-19 pandemic: a qualitative study

Por: Moussallem · M. · Zein-El-Din · A. · Hamra · R. · Rady · A. · Kosremelli Asmar · M. · Bou-Orm · I. R.
Objectives

This study aimed to assess the capacities and governance of Lebanon’s health system throughout the response to the COVID-19 pandemic until August 2020.

Design

A qualitative study based on semi-structured interviews.

Setting

Lebanon, February–August 2020.

Participants

Selected participants were directly or indirectly involved in the national or organisational response to the COVID-19 pandemic in Lebanon.

Results

A total of 41 participants were included in the study. ‘Hardware’ capacities of the system were found to be responsive yet deeply influenced by the challenging national context. The health workforce showed high levels of resilience, despite the shortage of medical staff and gaps in training at the early stages of the pandemic. The system infrastructure, medical supplies and testing capacities were sufficient, but the reluctance of the private sector in care provision and gaps in reimbursement of COVID-19 care by many health funding schemes were the main concerns. Moreover, the public health surveillance system was overwhelmed a few months after the start of the pandemic. As for the system ‘software’, there were attempts for a participatory governance mechanism, but the actual decision-making process was challenging with limited cooperation and strategic vision, resulting in decreased trust and increased confusion among communities. Moreover, the power imbalance between health actors and other stakeholders affected decision-making dynamics and the uptake of scientific evidence in policy-making.

Conclusions

Interventions adopting a centralised and reactive approach were prominent in Lebanon’s response to the COVID-19 pandemic. Better public governance and different reforms are needed to strengthen the health system preparedness and capacities to face future health security threats.

Adverse events and overall health and well-being after COVID-19 vaccination: interim results from the VAC4COVID cohort safety study

Por: Rogers · A. · Rooke · E. · Morant · S. · Guthrie · G. · Doney · A. · Duncan · A. · Mackenzie · I. · Barr · R. · Pigazzani · F. · Zutis · K. · MacDonald · T. M.
Objectives

To describe the incidence of adverse events (AEs), reactogenicity symptoms, menstrual changes and overall self-rated improvement in health and well-being after COVID-19 vaccination.

Design

VAC4COVID is an ongoing prospective, active observational, post-authorisation cohort safety study (PASS) of UK-approved vaccines for COVID-19 disease.

Setting

The study is conducted through a secure website (www.vac4covid.com) by MEMO Research, University of Dundee, UK.

Participants

16 265 adult (18 years or older) UK residents with a valid email address and internet access.

Interventions

Any UK-authorised COVID-19 vaccination.

Main outcome measures

The outcomes reported in this interim analysis include AEs, reactogenicity-type AEs (headache, fatigue, muscle or joint pain, fever, nausea, dizziness or local vaccine reaction), menstrual changes and reported improvement in overall health and well-being.

Results

11 475 consented participants (mean age 54.8 years) provided follow-up data between 2 February and 5 October 2021 (mean follow-up duration 184 days), by which date 89.2% of participants had received two vaccine doses. 89.8% of 5222 participants who completed a follow-up questionnaire in the 7 days after any COVID-19 vaccination reported no AEs. The risk of experiencing any event (not necessarily vaccine-related) requiring hospitalisation was less than 0.2%. 43.7% of post-vaccination follow-up records reported improvement in health and well-being. Reactogenicity-type reactions were more common in the week after the first dose of ChAdOx1 than BNT162b2 (7.8% vs 1.6%), but this relationship was reversed after the second dose (1.3% vs 3.1%). 0.3% of women reported menstrual symptoms after vaccination; no differences between vaccine type or dose order were detected.

Conclusions

The study provides reassuring data on low rates of AEs after COVID-19 vaccination. Differences in reactogenicity-type AE profiles between ChAdOx1 and BNT162b2 and between first and second doses of these vaccines were observed.

Trial registration number

ISRCTN95881792; Pre-results.

Cohort profile: maternal and child health and parenting practices during the COVID-19 pandemic in Ceara, Brazil: birth cohort study (Iracema-COVID)

Por: Castro · M. C. · Farias-Antunez · S. · Araujo · D. A. B. S. · Penna · A. L. · Oliveira · F. A. · de Aquino · C. M. · Lima Neto · A. S. · de Sousa · G. d. S. · Tavares Machado · M. M.
Purpose

Maternal and child health and parenting practices during the COVID-19 pandemic in Ceará (Iracema-COVID) is a longitudinal, prospective population-based birth cohort designed to understand the effects of the pandemic and social withdrawal in maternal mental health, child development and parenting practices of mothers and families.

Participants

A sample of mothers who gave birth in July and August 2020 (n=351) was enrolled in the study in January 2021. Interviews were conducted by telephone. Data were collected through standardised questionnaires that, in addition to sociodemographic and economic data, collected information on breast feeding, mental health status and COVID-19.

Findings to date

Results from the first wave show that the majority of participants have 9–11 years of schooling (54.4%; 95% CI 61.0 to 70.9) and are of mixed race (71.5%; 95% CI 66.5 to 76.0). At the time of the survey, 27.9% of the participants were out of the labor force (95% CI 23.5 to 32.9) and 78.6% reported a decrease in family income after restrictions imposed due to the pandemic (95% CI 74.0 to 82.6). The prevalence of maternal common mental disorder symptoms was 32.5% (95% CI 27.8 to 37.6).

Future plans

Follow-up visits are planned to occur every 6 months for the next five years (2021–2025). Additional topics will be included in future waves (eg, food insecurity and parenting practices). Communication strategies for bonding, such as picture cards, pictures of mothers with their children and phone calls to the participants, will be used to minimise attrition. Results of this prospective cohort will generate novel knowledge on the impact of the COVID-19 pandemic on maternal and child health and parenting practices in a population of women and children living in fifth largest city of Brazil.

Experience of Kenyan researchers and policy-makers with knowledge translation during COVID-19: a qualitative interview study

Por: Guleid · F. H. · Njeru · A. · Kiptim · J. · Kamuya · D. M. · Okiro · E. · Tsofa · B. · English · M. · Molyneux · S. · Kariuki · D. · Barasa · E.
Objectives

Researchers at the KEMRI-Wellcome Trust Research Programme (KWTRP) carried out knowledge translation (KT) activities to support policy-makers as the Kenyan Government responded to the COVID-19 pandemic. We assessed the usefulness of these activities to identify the facilitators and barriers to KT and suggest actions that facilitate KT in similar settings.

Design

The study adopted a qualitative interview study design.

Setting and participants

Researchers at KWTRP in Kenya who were involved in KT activities during the COVID-19 pandemic (n=6) were selected to participate in key informant interviews to describe their experience. In addition, the policy-makers with whom these researchers engaged were invited to participate (n=11). Data were collected from March 2021 to August 2021.

Analysis

A thematic analysis approach was adopted using a predetermined framework to develop a coding structure consisting of the core thematic areas. Any other theme that emerged in the coding process was included.

Results

Both groups reported that the KT activities increased evidence availability and accessibility, enhanced policy-makers’ motivation to use evidence, improved capacity to use research evidence and strengthened relationships. Policy-makers shared that a key facilitator of this was the knowledge products shared and the regular interaction with researchers. Both groups mentioned that a key barrier was the timeliness of generating evidence, which was exacerbated by the pandemic. They felt it was important to institutionalise KT to improve readiness to respond to public health emergencies.

Conclusion

This study provides a real-world example of the use of KT during a public health crisis. It further highlights the need to institutionalise KT in research and policy institutions in African countries to respond readily to public health emergencies.

Health systems analysis and evaluation of the barriers to availability, utilisation and readiness of sexual and reproductive health services in COVID-19-affected areas: a WHO mixed-methods study protocol

Por: Kouanda · S. · Nahyuha Chomi · E. · Kim · C. · Jen · S. · Bahamondes · L. · Cecatti · J. G. · Lumbiganon · P. · Emefa · M. · Brizuela · V. · Kuganantham · H. · Seuc · A. H. · Ali · M. · WHO HRP Social Science Research Team · Bahamondes · Cecatti · Chomi · Kouanda · Tang · Zhang · Zhu
Introduction

COVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings.

Methods and analysis

This study adopts both quantitative and qualitative methods to assess health facilities’ SRH service availability and readiness, and clients’ and providers’ perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey.

Ethics and dissemination

Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country.

Clinicodemographic profile and predictors of poor outcome in hospitalised COVID-19 patients: a single-centre, retrospective cohort study from India

Por: Tiwari · L. · Gupta · P. · N · Y. · Banerjee · A. · Kumar · Y. · Singh · P. K. · Ranjan · A. · Singh · C. M. · Singh · P. K.
Objectives

Primary objective was to study the clinicodemographic profile of hospitalised COVID-19 patients at a tertiary-care centre in India. Secondary objective was to identify predictors of poor outcome.

Setting

Single centre tertiary-care level.

Design

Retrospective cohort study.

Participants

Consecutively hospitalised adults patients with COVID-19.

Primary and secondary outcome measures

Primary outcome variable was in-hospital mortality. Covariables were known comorbidities, clinical features, vital signs at the time of admission and on days 3–5 of admission, and initial laboratory investigations.

Results

Intergroup differences were tested using 2 or Fischer’s exact tests, Student’s t-test or Mann-Whitney U test. Predictors of mortality were evaluated using multivariate logistic regression model. Out of 4102 SARS-CoV-2 positive patients admitted during 1-year period, 3268 (79.66%) survived to discharge and 834 (20.33%) died in the hospital. Mortality rates increased with age. Death was more common among males (OR 1.51, 95% CI 1.25 to 1.81). Out of 261 cases analysed in detail, 55.1% were in mild, 32.5% in moderate and 12.2% in severe triage category. Most common clinical presentations in the subgroup were fever (73.2%), cough/coryza (65.5%) and breathlessness (54%). Hypertension (45.2%), diabetes mellitus (41.8%) and chronic kidney disease (CKD; 6.1%) were common comorbidities. Disease severity on admission (adjusted OR 12.53, 95% CI 4.92 to 31.91, p

Conclusion

COVID-19 related mortality in hospitalised adult patients at our center was similar to the developed countries. Progression in disease severity on days 3–5 of admission or days 6–13 of illness onset acts as ‘turning point’ for timely referral or treatment intensification for optimum use of resources.

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