Changing Mindsets About Side Effects of the COVID-19 Vaccination: A Randomized Controlled Trial.

BACKGROUND: Side-effect concerns are a major barrier to vaccination against COVID-19 and other diseases. Identifying cost- and time-efficient interventions to improve vaccine experience and reduce vaccine hesitancy-without withholding information about side effects-is critical. PURPOSE: Determine whether a brief symptom as positive signals mindset intervention can improve vaccine experience and reduce vaccine hesitancy after the COVID-19 vaccination. METHODS: English-speaking adults (18+) were recruited during the 15-min wait period after receiving their second dose of the Pfizer COVID-19 vaccination and were randomly allocated to the symptom as positive signals mindset condition or the treatment as usual control. Participants in the mindset intervention viewed a 3:43-min video explaining how the body responds to vaccinations and how common side effects such as fatigue, sore arm, and fever are signs that the vaccination is helping the body boost immunity. The control group received standard vaccination center information. RESULTS: Mindset participants (N = 260) versus controls (N = 268) reported significantly less worry about symptoms at day 3 [t(506)=2.60, p=.01, d=0.23], fewer symptoms immediately following the vaccine [t(484)=2.75, p=.006, d=0.24], and increased intentions to vaccinate against viruses like COVID-19 in the future [t(514)=-2.57, p=.01, d=0.22]. No significant differences for side-effect frequency at day 3, coping, or impact. CONCLUSIONS: This study supports the use of a brief video aimed at reframing symptoms as positive signals to reduce worry and increase future vaccine intentions. CLINICAL TRIAL INFORMATION: Australian New Zealand Clinical Trials Registry: ACTRN12621000722897p.

Side-effect concerns are a major barrier to vaccination against COVID-19 and other diseases. Therefore, the purpose of this study was to determine whether a brief symptom as positive signals mindset intervention could improve vaccine experience and reduce vaccine hesitancy after the COVID-19 vaccination. Participants were recruited during the 15-min wait period after receiving their second dose of the Pfizer COVID-19 vaccination and were randomly allocated to a treatment as usual control condition or to a mindset intervention condition which entailed watching a 3:43-min video explaining how the body responds to vaccinations and how common side effects such as fatigue, sore arm, and fever are signs that the vaccination is helping the body boost immunity. Compared with participants in the control condition, participants in the mindset intervention condition reported significantly less worry about symptoms at day 3, fewer symptoms immediately following the vaccine and increased intentions to vaccinate against viruses like COVID-19 in the future. No significant differences emerged for side-effect frequency at day 3, coping, or impact. These finding provide initial support for cost- and time-efficient interventions to improve vaccine experience and reduce vaccine hesitancy without withholding information about side effects.Keywords: Vaccination ∙ Mindset ∙ COVID-19 ∙ Health Communication ∙ Symptoms.

Representativeness, Vaccination Uptake, and COVID-19 Clinical Outcomes 2020-2021 in the UK Oxford-Royal College of General Practitioners Research and Surveillance Network: Cohort Profile Summary.

BACKGROUND: The Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) is one of Europe's oldest sentinel systems, working with the UK Health Security Agency (UKHSA) and its predecessor bodies for 55 years. Its surveillance report now runs twice weekly, supplemented by online observatories. In addition to conducting sentinel surveillance from a nationally representative group of practices, the RSC is now also providing data for syndromic surveillance. OBJECTIVE: The aim of this study was to describe the cohort profile at the start of the 2021-2022 surveillance season and recent changes to our surveillance practice. METHODS: The RSC's pseudonymized primary care data, linked to hospital and other data, are held in the Oxford-RCGP Clinical Informatics Digital Hub, a Trusted Research Environment. We describe the RSC's cohort profile as of September 2021, divided into a Primary Care Sentinel Cohort (PCSC)-collecting virological and serological specimens-and a larger group of syndromic surveillance general practices (SSGPs). We report changes to our sampling strategy that brings the RSC into alignment with European Centre for Disease Control guidance and then compare our cohort's sociodemographic characteristics with Office for National Statistics data. We further describe influenza and COVID-19 vaccine coverage for the 2020-2021 season (week 40 of 2020 to week 39 of 2021), with the latter differentiated by vaccine brand. Finally, we report COVID-19-related outcomes in terms of hospitalization, intensive care unit (ICU) admission, and death. RESULTS: As a response to COVID-19, the RSC grew from just over 500 PCSC practices in 2019 to 1879 practices in 2021 (PCSC, n=938; SSGP, n=1203). This represents 28.6% of English general practices and 30.59% (17,299,780/56,550,136) of the population. In the reporting period, the PCSC collected >8000 virology and >23,000 serology samples. The RSC population was broadly representative of the national population in terms of age, gender, ethnicity, National Health Service Region, socioeconomic status, obesity, and smoking habit. The RSC captured vaccine coverage data for influenza (n=5.4 million) and COVID-19, reporting dose one (n=11.9 million), two (n=11 million), and three (n=0.4 million) for the latter as well as brand-specific uptake data (AstraZeneca vaccine, n=11.6 million; Pfizer, n=10.8 million; and Moderna, n=0.7 million). The median (IQR) number of COVID-19 hospitalizations and ICU admissions was 1181 (559-1559) and 115 (50-174) per week, respectively. CONCLUSIONS: The RSC is broadly representative of the national population; its PCSC is geographically representative and its SSGPs are newly supporting UKHSA syndromic surveillance efforts. The network captures vaccine coverage and has expanded from reporting primary care attendances to providing data on onward hospital outcomes and deaths. The challenge remains to increase virological and serological sampling to monitor the effectiveness and waning of all vaccines available in a timely manner.

National rates and disparities in childhood vaccination and vaccine-preventable disease during the COVID-19 pandemic: English sentinel network retrospective database study.

OBJECTIVES: To describe rates and variation in uptake of pneumococcal and measles, mumps and rubella (MMR) vaccines in children and associated change in vaccine-preventable diseases (VPDs) across the first and second waves of the COVID-19 pandemic. METHODS: Retrospective database study of all children aged <19 registered with a general practice in the Oxford Royal College of General Practitioners Research and Surveillance Centre English national sentinel surveillance network between 2 November 2015 and 18 July 2021. RESULTS: Coverage of booster dose of pneumococcal vaccine decreased from 94.5% (95% CI 94.3% to 94.7%) at its height on International Organization for Standardization (ISO) week 47 (2020) to 93.6% (95% CI 93.4% to 93.8%) by the end of the study. Coverage of second dose of MMR decreased from 85.0% (95% CI 84.7% to 85.3%) at its height on ISO week 37 (2020) to 84.1% (95% CI 83.8% to 84.4%) by the end of the study. The break point in trends for MMR was at ISO week 34 (2020) (95% CI weeks 32-37 (2020)), while for pneumococcal vaccine the break point was later at ISO week 3 (2021) (95% CI week 53 (2020) to week 8 (2021)). Vaccination coverage for children of white ethnicity was less likely to decrease than other ethnicities. Rates of consultation for VPDs fell and remained low since August 2020. CONCLUSION: Childhood vaccination rates started to fall ahead of the onset of the second wave; this fall is accentuating ethnic, socioeconomic and geographical disparities in vaccine uptake and risks widening health disparities. Social distancing and school closures may have contributed to lower rates of associated VPDs, but there may be increased risk as these measures are removed.

Politicians: please work together to minimise the spread of COVID-19

If the virus spreads further throughout our communities, and authorities ask people to limit social contact and self-isolate, cooperation with these necessary measures will play a crucial role in minimising COVID-19's spread and protecting the most vulnerable among us. Teams of infectious disease, public health and primary care experts are advising the Government on the best way to deal with this threat.

Antimicrobial stewardship in human healthcare in Aotearoa New Zealand: urgent call for national leadership and co-ordinated efforts to preserve antimicrobial effectiveness

Within 30 years, the global number of deaths from AMR-associated infections is predicted to increase from ~700,000 to ~10 million people annually, if we do not act now.1 The Aotearoa New Zealand (NZ) response to the current COVID-19 pandemic has been lauded internationally-found-ed in science, responsive to expert advice, implemented with clear leadership and communication, and subject to ongoing critical evaluation and improvement. AMR-associated infections and related care (eg, time off work or school to travel to hospital for treatment) will disproportionately impact the most socioeconomically disadvantaged among us, those living in rural or remote settings, and Maori and Pacific populations who shoulder a greater infection and AMR burden and have increased reliance on antimicrobial therapy.6'7 One of the biggest drivers for AMR is antimicrobial use, which is high in human health in NZ compared with many developed countries.8'9 Most of our antimicrobial use (95%) is in the community9 and up to 50% may be inappropriate.2 The NZ community antibacterial consumption rate increased 49% between 2006 and 2014;in 2013, it exceeded that of 22 out of 29 European countries.8 A subsequent modest 14% decrease occurred across 2015 to 2018, mainly due to reductions in under 5 year olds,10 which is pleasing as antimicrobial use in childhood may create reservoirs of resistant pathogens impacting communities cross-generationally. In 2013, the Health Quality and Safety Commission (HQSC) published a scoping report that offered insight into what was needed to progress AMS in NZ.14 Key recommendations were to establish: * National leadership and coordination of AMS activities * National antimicrobial prescribing guidelines * Quality improvement tools and measures In the near decade that has followed this report, none of these recommendations have been achieved. The NCAMS should provide access to (and support use of) quality improvement tools (eg, auditing systems for between facility benchmarking), develop initiatives to improve antimicrobial use (including those involving consumers), monitor performance against quality markers, and establish clinical care standards with the oversight of NAMSEG.

The impacts of New Zealand's COVID-19 epidemic response on community antibiotic use and hospitalisation for pneumonia, peritonsillar abscess and rheumatic fever.

BACKGROUND: The rate of community antibiotic use in New Zealand (NZ) is high and some may be unnecessary. Non-pharmaceutical public health interventions (Alert Levels) were implemented in 2020 to reduce the spread of COVID-19 in NZ and were likely to have affected antibiotic prescribing. METHODS: We aimed to identify the impact of these public health interventions on community antibiotic dispensing. We also examined rates of hospitalisation with infectious diseases that could be influenced by changing community antibiotic use. A retrospective review of two national databases was undertaken. FINDINGS: 1.17 million people received 1.19 million prescriptions for antibiotics between 23/02/2020 and 18/07/2020. Antibiotic dispensing rates fell from 14 prescriptions per 1000 population per week during pre-Alert Level weeks to 9 prescriptions per 1000 population per week (a reduction of 36%) during the weeks of COVID Alert Level 3-4. Large reductions were seen with antibiotics predominantly used for respiratory- or urinary-tract infections. Hospital discharges with sentinel infections did not increase over this period; pneumonia discharges during Alert Level weeks were lower than in 2017-2019 (3 vs 6 discharges per 100,000 population). INTERPRETATION: A large reduction in community antibiotic dispensing was observed in NZ during the implementation of non-pharmaceutical public health interventions to eliminate COVID-19. Despite this marked reduction in antibiotic use, there was no increase in rates of hospitalisation for sentinel infections that community antibiotic use could prevent. These findings suggest that countries with high rates of antibiotic use could significantly reduce their use without an increase in morbidity. FUNDING: No financial support received.

Fabry disease and COVID-19: international expert recommendations for management based on real-world experience.

The rapid spread of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 has raised questions about Fabry disease (FD) as an independent risk factor for severe COVID-19 symptoms. Available real-world data on 22 patients from an international group of healthcare providers reveals that most patients with FD experience mild-to-moderate COVID-19 symptoms with an additional complication of Fabry pain crises and transient worsening of kidney function in some cases; however, two patients over the age of 55 years with renal or cardiac disease experienced critical COVID-19 complications. These outcomes support the theory that pre-existent tissue injury and inflammation may predispose patients with more advanced FD to a more severe course of COVID-19, while less advanced FD patients do not appear to be more susceptible than the general population. Given these observed risk factors, it is best to reinforce all recommended safety precautions for individuals with advanced FD. Diagnosis of FD should not preclude providing full therapeutic and organ support as needed for patients with FD and severe or critical COVID-19, although a FD-specific safety profile review should always be conducted prior to initiating COVID-19-specific therapies. Continued specific FD therapy with enzyme replacement therapy, chaperone therapy, dialysis, renin-angiotensin blockers or participation to clinical trials during the pandemic is recommended as FD progression will only increase susceptibility to infection. In order to compile outcome data and inform best practices, an international registry for patients affected by Fabry and infected by COVID-19 should be established.

The Oxford Royal College of General Practitioners Clinical Informatics Digital Hub: Protocol to Develop Extended COVID-19 Surveillance and Trial Platforms.

BACKGROUND: Routinely recorded primary care data have been used for many years by sentinel networks for surveillance. More recently, real world data have been used for a wider range of research projects to support rapid, inexpensive clinical trials. Because the partial national lockdown in the United Kingdom due to the coronavirus disease (COVID-19) pandemic has resulted in decreasing community disease incidence, much larger numbers of general practices are needed to deliver effective COVID-19 surveillance and contribute to in-pandemic clinical trials. OBJECTIVE: The aim of this protocol is to describe the rapid design and development of the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) and its first two platforms. The Surveillance Platform will provide extended primary care surveillance, while the Trials Platform is a streamlined clinical trials platform that will be integrated into routine primary care practice. METHODS: We will apply the FAIR (Findable, Accessible, Interoperable, and Reusable) metadata principles to a new, integrated digital health hub that will extract routinely collected general practice electronic health data for use in clinical trials and provide enhanced communicable disease surveillance. The hub will be findable through membership in Health Data Research UK and European metadata repositories. Accessibility through an online application system will provide access to study-ready data sets or developed custom data sets. Interoperability will be facilitated by fixed linkage to other key sources such as Hospital Episodes Statistics and the Office of National Statistics using pseudonymized data. All semantic descriptors (ie, ontologies) and code used for analysis will be made available to accelerate analyses. We will also make data available using common data models, starting with the US Food and Drug Administration Sentinel and Observational Medical Outcomes Partnership approaches, to facilitate international studies. The Surveillance Platform will provide access to data for health protection and promotion work as authorized through agreements between Oxford, the Royal College of General Practitioners, and Public Health England. All studies using the Trials Platform will go through appropriate ethical and other regulatory approval processes. RESULTS: The hub will be a bottom-up, professionally led network that will provide benefits for member practices, our health service, and the population served. Data will only be used for SQUIRE (surveillance, quality improvement, research, and education) purposes. We have already received positive responses from practices, and the number of practices in the network has doubled to over 1150 since February 2020. COVID-19 surveillance has resulted in tripling of the number of virology sites to 293 (target 300), which has aided the collection of the largest ever weekly total of surveillance swabs in the United Kingdom as well as over 3000 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology samples. Practices are recruiting to the PRINCIPLE (Platform Randomised trial of INterventions against COVID-19 In older PeopLE) trial, and these participants will be followed up through ORCHID. These initial outputs demonstrate the feasibility of ORCHID to provide an extended national digital health hub. CONCLUSIONS: ORCHID will provide equitable and innovative use of big data through a professionally led national primary care network and the application of FAIR principles. The secure data hub will host routinely collected general practice data linked to other key health care repositories for clinical trials and support enhanced in situ surveillance without always requiring large volume data extracts. ORCHID will support rapid data extraction, analysis, and dissemination with the aim of improving future research and development in general practice to positively impact patient care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19773.

Telemedicine During COVID-19 and Beyond: A Practical Guide and Best Practices Multidisciplinary Approach for the Orthopedic and Neurologic Pain Physical Examination.

BACKGROUND: The COVID pandemic has impacted almost every aspect of human interaction, causing global changes in financial, health care, and social environments for the foreseeable future. More than 1.3 million of the 4 million cases of COVID-19 confirmed globally as of May 2020 have been identified in the United States, testing the capacity and resilience of our hospitals and health care workers. The impacts of the ongoing pandemic, caused by a novel strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), have far-reaching implications for the future of our health care system and how we deliver routine care to patients. The adoption of social distancing during this pandemic has demonstrated efficacy in controlling the spread of this virus and has been the only proven means of infection control thus far. Social distancing has prompted hospital closures and the reduction of all non-COVID clinical visits, causing widespread financial despair to many outpatient centers. However, the need to treat patients for non-COVID problems remains important despite this pandemic, as care must continue to be delivered to patients despite their ability or desire to report to outpatient centers for their general care. Our national health care system has realized this need and has incentivized providers to adopt distance-based care in the form of telemedicine and video medicine visits. Many institutions have since incorporated these into their practices without financial penalty because of Medicare's 1135 waiver, which currently reimburses telemedicine at the same rate as evaluation and management codes (E/M Codes). Although the financial burden has been alleviated by this policy, the practitioner remains accountable for providing proper assessment with this new modality of health care delivery. This is a challenge for most physicians, so our team of national experts has created a reference guide for musculoskeletal and neurologic examination selection to retrofit into the telemedicine experience. OBJECTIVES: To describe and illustrate musculoskeletal and neurologic examination techniques that can be used effectively in telemedicine. STUDY DESIGN: Consensus-based multispecialty guidelines. SETTING: Tertiary care center. METHODS: Literature review of the neck, shoulder, elbow, wrist, hand, lumbar, hip, and knee physical examinations were performed. A multidisciplinary team comprised of physical medicine and rehabilitation, orthopedics, rheumatology, neurology, and anesthesia experts evaluated each examination and provided consensus opinion to select the examinations most appropriate for telemedicine evaluation. The team also provided consensus opinion on how to modify some examinations to incorporate into a nonhealth care office setting. RESULTS: Sixty-nine examinations were selected by the consensus team. Household objects were identified that modified standard and validated examinations, which could facilitate the examinations.The consensus review team did not believe that the modified tests altered the validity of the standardized tests. LIMITATIONS: Examinations selected are not validated for telemedicine. Qualitative and quantitative analyses were not performed. CONCLUSIONS: The physical examination is an essential component for sound clinical judgment and patient care planning. The physical examinations described in this manuscript provide a comprehensive framework for the musculoskeletal and neurologic examination, which has been vetted by a committee of national experts for incorporation into the telemedicine evaluation.

Redefining Pathways into Acute Rehabilitation during the COVID-19 Crisis.

The coronavirus disease 2019 (COVID-19) pandemic has necessitated drastic changes across the spectrum of health care, all of which have occurred with unprecedented rapidity. The need to accommodate change on such a large scale has required ingenuity and decisive thinking. The field of physical medicine and rehabilitation has been faced with many of these challenges. Healthcare practitioners in New York City, the epicenter of the pandemic in the United States, were among the first to encounter many of these challenges. One of the largest lessons included learning how to streamline admissions and transfer process into an acute rehabilitation hospital as part of a concerted effort to make acute care hospital beds available as quickly as possible.