Adapting domestic abuse training to remote delivery during the COVID-19 pandemic: a qualitative study of views from general practice and support services.

BACKGROUND: Identifying and responding to patients affected by domestic violence and abuse (DVA) is vital in primary care. There may have been a rise in the reporting of DVA cases during the COVID-19 pandemic and associated lockdown measures. Concurrently general practice adopted remote working that extended to training and education. IRIS (Identification and Referral to Improve Safety) is an example of an evidence-based UK healthcare training support and referral programme, focusing on DVA. IRIS transitioned to remote delivery during the pandemic. AIM: To understand the adaptations and impact of remote DVA training in IRIS-trained general practices by exploring perspectives of those delivering and receiving training. DESIGN AND SETTING: Qualitative interviews and observation of remote training of general practice teams in England were undertaken. METHOD: Semi-structured interviews were conducted with 21 participants (three practice managers, three reception and administrative staff, eight general practice clinicians, and seven specialist DVA staff), alongside observation of eight remote training sessions. Analysis was conducted using a framework approach. RESULTS: Remote DVA training in UK general practice widened access to learners. However, it may have reduced learner engagement compared with face-to-face training and may challenge safeguarding of remote learners who are domestic abuse survivors. DVA training is integral to the partnership between general practice and specialist DVA services, and reduced engagement risks weakening this partnership. CONCLUSION: The authors recommend a hybrid DVA training model for general practice, including remote information delivery alongside a structured face-to-face element. This has broader relevance for other specialist services providing training and education in primary care.

General practice wide adaptations to support patients affected by DVA during the COVID-19 pandemic: a rapid qualitative study.

BACKGROUND: Reporting of domestic violence and abuse (DVA) increased globally during the pandemic. General Practice has a central role in identifying and supporting those affected by DVA. Pandemic associated changes in UK primary care included remote initial contacts with primary care and predominantly remote consulting. This paper explores general practice's adaptation to DVA care during the COVID-19 pandemic. METHODS: Remote semi-structured interviews were conducted by telephone with staff from six localities in England and Wales where the Identification and Referral to Improve Safety (IRIS) primary care DVA programme is commissioned.  We conducted interviews between April 2021 and February 2022 with three practice managers, three reception and administrative staff, eight general practice clinicians and seven specialist DVA staff. Patient and public involvement and engagement (PPI&E) advisers with lived experience of DVA guided the project. Together we developed recommendations for primary care teams based on our findings. RESULTS: We present our findings within four themes, representing primary care adaptations in delivering DVA care: 1. Making general practice accessible for DVA care: staff adapted telephone triaging processes for appointments and promoted availability of DVA support online. 2. General practice team-working to identify DVA: practices developed new approaches of collaboration, including whole team adaptations to information processing and communication 3. Adapting to remote consultations about DVA: teams were required to adapt to challenges including concerns about safety, privacy, and developing trust remotely. 4. Experiences of onward referrals for specialist DVA support: support from specialist services was effective and largely unchanged during the pandemic. CONCLUSIONS: Disruption caused by pandemic restrictions revealed how team dynamics and interactions before, during and after clinical consultations contribute to identifying and supporting patients experiencing DVA. Remote assessment complicates access to and delivery of DVA care. This has implications for all primary and secondary care settings, within the NHS and internationally, which are vital to consider in both practice and policy.

Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age and Sex.

BACKGROUND: Myocarditis is more common after severe acute respiratory syndrome coronavirus 2 infection than after COVID-19 vaccination, but the risks in younger people and after sequential vaccine doses are less certain. METHODS: A self-controlled case series study of people ages 13 years or older vaccinated for COVID-19 in England between December 1, 2020, and December 15, 2021, evaluated the association between vaccination and myocarditis, stratified by age and sex. The incidence rate ratio and excess number of hospital admissions or deaths from myocarditis per million people were estimated for the 1 to 28 days after sequential doses of adenovirus (ChAdOx1) or mRNA-based (BNT162b2, mRNA-1273) vaccines, or after a positive SARS-CoV-2 test. RESULTS: In 42 842 345 people receiving at least 1 dose of vaccine, 21 242 629 received 3 doses, and 5 934 153 had SARS-CoV-2 infection before or after vaccination. Myocarditis occurred in 2861 (0.007%) people, with 617 events 1 to 28 days after vaccination. Risk of myocarditis was increased in the 1 to 28 days after a first dose of ChAdOx1 (incidence rate ratio, 1.33 [95% CI, 1.09-1.62]) and a first, second, and booster dose of BNT162b2 (1.52 [95% CI, 1.24-1.85]; 1.57 [95% CI, 1.28-1.92], and 1.72 [95% CI, 1.33-2.22], respectively) but was lower than the risks after a positive SARS-CoV-2 test before or after vaccination (11.14 [95% CI, 8.64-14.36] and 5.97 [95% CI, 4.54-7.87], respectively). The risk of myocarditis was higher 1 to 28 days after a second dose of mRNA-1273 (11.76 [95% CI, 7.25-19.08]) and persisted after a booster dose (2.64 [95% CI, 1.25-5.58]). Associations were stronger in men younger than 40 years for all vaccines. In men younger than 40 years old, the number of excess myocarditis events per million people was higher after a second dose of mRNA-1273 than after a positive SARS-CoV-2 test (97 [95% CI, 91-99] versus 16 [95% CI, 12-18]). In women younger than 40 years, the number of excess events per million was similar after a second dose of mRNA-1273 and a positive test (7 [95% CI, 1-9] versus 8 [95% CI, 6-8]). CONCLUSIONS: Overall, the risk of myocarditis is greater after SARS-CoV-2 infection than after COVID-19 vaccination and remains modest after sequential doses including a booster dose of BNT162b2 mRNA vaccine. However, the risk of myocarditis after vaccination is higher in younger men, particularly after a second dose of the mRNA-1273 vaccine.

Associations of BMI with COVID-19 vaccine uptake, vaccine effectiveness, and risk of severe COVID-19 outcomes after vaccination in England: a population-based cohort study.

BACKGROUND: A high BMI has been associated with a reduced immune response to vaccination against influenza. We aimed to investigate the association between BMI and COVID-19 vaccine uptake, vaccine effectiveness, and risk of severe COVID-19 outcomes after vaccination by using a large, representative population-based cohort from England. METHODS: In this population-based cohort study, we used the QResearch database of general practice records and included patients aged 18 years or older who were registered at a practice that was part of the database in England between Dec 8, 2020 (date of the first vaccination in the UK), to Nov 17, 2021, with available data on BMI. Uptake was calculated as the proportion of people with zero, one, two, or three doses of the vaccine across BMI categories. Effectiveness was assessed through a nested matched case-control design to estimate odds ratios (OR) for severe COVID-19 outcomes (ie, admission to hospital or death) in people who had been vaccinated versus those who had not, considering vaccine dose and time periods since vaccination. Vaccine effectiveness against infection with SARS-CoV-2 was also investigated. Multivariable Cox proportional hazard models estimated the risk of severe COVID-19 outcomes associated with BMI (reference BMI 23 kg/m2) after vaccination. FINDINGS: Among 9 171 524 participants (mean age 52 [SD 19] years; BMI 26·7 [5·6] kg/m2), 566 461 tested positive for SARS-CoV-2 during follow-up, of whom 32 808 were admitted to hospital and 14 389 died. Of the total study sample, 19·2% (1 758 689) were unvaccinated, 3·1% (287 246) had one vaccine dose, 52·6% (4 828 327) had two doses, and 25·0% (2 297 262) had three doses. In people aged 40 years and older, uptake of two or three vaccine doses was more than 80% among people with overweight or obesity, which was slightly lower in people with underweight (70-83%). Although significant heterogeneity was found across BMI groups, protection against severe COVID-19 disease (comparing people who were vaccinated vs those who were not) was high after 14 days or more from the second dose for hospital admission (underweight: OR 0·51 [95% CI 0·41-0·63]; healthy weight: 0·34 [0·32-0·36]; overweight: 0·32 [0·30-0·34]; and obesity: 0·32 [0·30-0·34]) and death (underweight: 0·60 [0·36-0·98]; healthy weight: 0·39 [0·33-0·47]; overweight: 0·30 [0·25-0·35]; and obesity: 0·26 [0·22-0·30]). In the vaccinated cohort, there were significant linear associations between BMI and COVID-19 hospitalisation and death after the first dose, and J-shaped associations after the second dose. INTERPRETATION: Using BMI categories, there is evidence of protection against severe COVID-19 in people with overweight or obesity who have been vaccinated, which was of a similar magnitude to that of people of healthy weight. Vaccine effectiveness was slightly lower in people with underweight, in whom vaccine uptake was also the lowest for all ages. In the vaccinated cohort, there were increased risks of severe COVID-19 outcomes for people with underweight or obesity compared with the vaccinated population with a healthy weight. These results suggest the need for targeted efforts to increase uptake in people with low BMI (<18·5 kg/m2), in whom uptake is lower and vaccine effectiveness seems to be reduced. Strategies to achieve and maintain a healthy weight should be prioritised at the population level, which could help reduce the burden of COVID-19 disease. FUNDING: UK Research and Innovation and National Institute for Health Research Oxford Biomedical Research Centre.

Impact of the first national COVID-19 lockdown on referral of women experiencing domestic violence and abuse in England and Wales.

BACKGROUND: The lockdown periods to curb COVID-19 transmission have made it harder for survivors of domestic violence and abuse (DVA) to disclose abuse and access support services. Our study describes the impact of the first COVID-19 wave and the associated national lockdown in England and Wales on the referrals from general practice to the Identification and Referral to Improve Safety (IRIS) DVA programme. We compare this to the change in referrals in the same months in the previous year, during the school holidays in the 3 years preceding the pandemic and the period just after the first COVID-19 wave. School holiday periods were chosen as a comparator, since families, including the perpetrator, are together, affecting access to services. METHODS: We used anonymised data on daily referrals received by the IRIS DVA service in 33 areas from general practices over the period April 2017-September 2020. Interrupted-time series and non-linear regression were used to quantify the impact of the first national lockdown in March-June 2020 comparing analogous months the year before, and the impact of school holidays (01/04/2017-30/09/2020) on number of referrals, reporting Incidence Rate Ratio (IRR), 95% confidence intervals and p-values. RESULTS: The first national lockdown in 2020 led to reduced number of referrals to DVA services (27%, 95%CI = (21,34%)) compared to the period before and after, and 19% fewer referrals compared to the same period in the year before. A reduction in the number of referrals was also evident during the school holidays with the highest reduction in referrals during the winter 2019 pre-pandemic school holiday (44%, 95%CI = (32,54%)) followed by the effect from the summer of 2020 school holidays (20%, 95%CI = (10,30%)). There was also a smaller reduction (13-15%) in referrals during the longer summer holidays 2017-2019; and some reduction (5-16%) during the shorter spring holidays 2017-2019. CONCLUSIONS: We show that the COVID-19 lockdown in 2020 led to decline in referrals to DVA services. Our findings suggest an association between decline in referrals to DVA services for women experiencing DVA and prolonged periods of systemic closure proxied here by both the first COVID-19 national lockdown or school holidays. This highlights the need for future planning to provide adequate access and support for people experiencing DVA during future national lockdowns and during the school holidays.

Challenges of safeguarding via remote consulting during the COVID-19 pandemic: a qualitative interview study.

BACKGROUND: The COVID-19 pandemic required general practice to rapidly adapt to remote consultations and assessment of patients, creating new, and exacerbating existing, vulnerabilities for many patients. AIM: To explore GP perspectives and concerns about safeguarding practice during the pandemic, focusing on challenges and opportunities created by remote consultation. DESIGN AND SETTING: Qualitative interview study. METHOD: Eighteen GPs from Oxford, London, Southampton, Liverpool, Manchester, and Reading were interviewed between June and November 2020, using a flexible topic guide and fictional vignettes to explore child and adult safeguarding scenarios. Interviews were audio-recorded, thematically coded, and analysed. RESULTS: GPs worried about missing observational information during remote consultations and that conversations might not be private or safe. Loss of continuity and pooled triage lists were seen as further weakening safeguarding opportunities. GPs experienced remote consulting as more 'transactional', with reduced opportunities to explore 'other reasons' including new safeguarding needs. However, they also recognised that remote consulting created opportunities for some vulnerable patients. While supporting known vulnerable patients was difficult, identifying new or unknown vulnerabilities was harder still. Most reported that remote consulting during COVID-19 was harder, riskier, and emotionally draining, contributing to increased GP anxiety and reduced job satisfaction. CONCLUSION: The GPs interviewed raised important concerns about how to identify and manage safeguarding in the context of remote consultations. Current guidance recommends face-to-face consultation for safeguarding concerns, but pressure to use remote forms of access (within or beyond the pandemic) and the fact that safeguarding needs may be unknown makes this an issue that warrants urgent attention.

Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection.

Although myocarditis and pericarditis were not observed as adverse events in coronavirus disease 2019 (COVID-19) vaccine trials, there have been numerous reports of suspected cases following vaccination in the general population. We undertook a self-controlled case series study of people aged 16 or older vaccinated for COVID-19 in England between 1 December 2020 and 24 August 2021 to investigate hospital admission or death from myocarditis, pericarditis and cardiac arrhythmias in the 1-28 days following adenovirus (ChAdOx1, n = 20,615,911) or messenger RNA-based (BNT162b2, n = 16,993,389; mRNA-1273, n = 1,006,191) vaccines or a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (n = 3,028,867). We found increased risks of myocarditis associated with the first dose of ChAdOx1 and BNT162b2 vaccines and the first and second doses of the mRNA-1273 vaccine over the 1-28 days postvaccination period, and after a SARS-CoV-2 positive test. We estimated an extra two (95% confidence interval (CI) 0, 3), one (95% CI 0, 2) and six (95% CI 2, 8) myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 (95% CI 38, 41) myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test. We also observed increased risks of pericarditis and cardiac arrhythmias following a positive SARS-CoV-2 test. Similar associations were not observed with any of the COVID-19 vaccines, apart from an increased risk of arrhythmia following a second dose of mRNA-1273. Subgroup analyses by age showed the increased risk of myocarditis associated with the two mRNA vaccines was present only in those younger than 40.

Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection.

Emerging reports of rare neurological complications associated with COVID-19 infection and vaccinations are leading to regulatory, clinical and public health concerns. We undertook a self-controlled case series study to investigate hospital admissions from neurological complications in the 28 days after a first dose of ChAdOx1nCoV-19 (n = 20,417,752) or BNT162b2 (n = 12,134,782), and after a SARS-CoV-2-positive test (n = 2,005,280). There was an increased risk of Guillain-Barré syndrome (incidence rate ratio (IRR), 2.90; 95% confidence interval (CI): 2.15-3.92 at 15-21 days after vaccination) and Bell's palsy (IRR, 1.29; 95% CI: 1.08-1.56 at 15-21 days) with ChAdOx1nCoV-19. There was an increased risk of hemorrhagic stroke (IRR, 1.38; 95% CI: 1.12-1.71 at 15-21 days) with BNT162b2. An independent Scottish cohort provided further support for the association between ChAdOx1nCoV and Guillain-Barré syndrome (IRR, 2.32; 95% CI: 1.08-5.02 at 1-28 days). There was a substantially higher risk of all neurological outcomes in the 28 days after a positive SARS-CoV-2 test including Guillain-Barré syndrome (IRR, 5.25; 95% CI: 3.00-9.18). Overall, we estimated 38 excess cases of Guillain-Barré syndrome per 10 million people receiving ChAdOx1nCoV-19 and 145 excess cases per 10 million people after a positive SARS-CoV-2 test. In summary, although we find an increased risk of neurological complications in those who received COVID-19 vaccines, the risk of these complications is greater following a positive SARS-CoV-2 test.

Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study.

OBJECTIVE: To assess the association between covid-19 vaccines and risk of thrombocytopenia and thromboembolic events in England among adults. DESIGN: Self-controlled case series study using national data on covid-19 vaccination and hospital admissions. SETTING: Patient level data were obtained for approximately 30 million people vaccinated in England between 1 December 2020 and 24 April 2021. Electronic health records were linked with death data from the Office for National Statistics, SARS-CoV-2 positive test data, and hospital admission data from the United Kingdom's health service (NHS). PARTICIPANTS: 29 121 633 people were vaccinated with first doses (19 608 008 with Oxford-AstraZeneca (ChAdOx1 nCoV-19) and 9 513 625 with Pfizer-BioNTech (BNT162b2 mRNA)) and 1 758 095 people had a positive SARS-CoV-2 test. People aged ≥16 years who had first doses of the ChAdOx1 nCoV-19 or BNT162b2 mRNA vaccines and any outcome of interest were included in the study. MAIN OUTCOME MEASURES: The primary outcomes were hospital admission or death associated with thrombocytopenia, venous thromboembolism, and arterial thromboembolism within 28 days of three exposures: first dose of the ChAdOx1 nCoV-19 vaccine; first dose of the BNT162b2 mRNA vaccine; and a SARS-CoV-2 positive test. Secondary outcomes were subsets of the primary outcomes: cerebral venous sinus thrombosis (CVST), ischaemic stroke, myocardial infarction, and other rare arterial thrombotic events. RESULTS: The study found increased risk of thrombocytopenia after ChAdOx1 nCoV-19 vaccination (incidence rate ratio 1.33, 95% confidence interval 1.19 to 1.47 at 8-14 days) and after a positive SARS-CoV-2 test (5.27, 4.34 to 6.40 at 8-14 days); increased risk of venous thromboembolism after ChAdOx1 nCoV-19 vaccination (1.10, 1.02 to 1.18 at 8-14 days) and after SARS-CoV-2 infection (13.86, 12.76 to 15.05 at 8-14 days); and increased risk of arterial thromboembolism after BNT162b2 mRNA vaccination (1.06, 1.01 to 1.10 at 15-21 days) and after SARS-CoV-2 infection (2.02, 1.82 to 2.24 at 15-21 days). Secondary analyses found increased risk of CVST after ChAdOx1 nCoV-19 vaccination (4.01, 2.08 to 7.71 at 8-14 days), after BNT162b2 mRNA vaccination (3.58, 1.39 to 9.27 at 15-21 days), and after a positive SARS-CoV-2 test; increased risk of ischaemic stroke after BNT162b2 mRNA vaccination (1.12, 1.04 to 1.20 at 15-21 days) and after a positive SARS-CoV-2 test; and increased risk of other rare arterial thrombotic events after ChAdOx1 nCoV-19 vaccination (1.21, 1.02 to 1.43 at 8-14 days) and after a positive SARS-CoV-2 test. CONCLUSION: Increased risks of haematological and vascular events that led to hospital admission or death were observed for short time intervals after first doses of the ChAdOx1 nCoV-19 and BNT162b2 mRNA vaccines. The risks of most of these events were substantially higher and more prolonged after SARS-CoV-2 infection than after vaccination in the same population.

PRimary care rEsponse to domestic violence and abuse in the COvid-19 panDEmic (PRECODE): protocol of a rapid mixed-methods study in the UK.

BACKGROUND: The implementation of lockdowns in the UK during the COVID-19 pandemic resulted in a system switch to remote primary care consulting at the same time as the incidence of domestic violence and abuse (DVA) increased. Lockdown-specific barriers to disclosure of DVA reduced the opportunity for DVA detection and referral. The PRECODE (PRimary care rEsponse to domestic violence and abuse in the COvid-19 panDEmic) study will comprise quantitative analysis of the impact of the pandemic on referrals from IRIS (Identification and Referral to Improve Safety) trained general practices to DVA agencies in the UK and qualitative analysis of the experiences of clinicians responding to patients affected by DVA and adaptations they have made transitioning to remote DVA training and patient support. METHODS/DESIGN: Using a rapid mixed method design, PRECODE will explore and explain the dynamics of DVA referrals and support before and during the pandemic on a national scale using qualitative data and over four years of referrals time series data. We will undertake interrupted-time series and non-linear regression analysis, including sensitivity analyses, on time series of referrals to DVA services from routinely collected data to evaluate the impact of the pandemic and associated lockdowns on referrals to the IRIS Programme, and analyse key determinants associated with changes in referrals. We will also conduct an interview- and observation-based qualitative study to understand the variation, relevance and feasibility of primary care responses to DVA before and during the pandemic and its aftermath. The triangulation of quantitative and qualitative findings using rapid analysis and synthesis will enable the articulation of multiscale trends in primary care responses to DVA and complex mechanisms by which these responses have changed during the pandemic. DISCUSSION: Our findings will inform the implementation of remote primary care and DVA service responses as services re-configure. Understanding the adaptation of clinical and service responses to DVA during the pandemic is crucial for the development of evidence-based, effective remote support and referral beyond the pandemic. TRIAL REGISTRATION: PRECODE is an observational epidemiologic study, not an intervention evaluation or trial. We will not be reporting results of an intervention on human participants.