Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months-5 Years - United States, June 17, 2022-May 7, 2023.

As of May 7, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) recommends that all children aged 6 months-5 years receive at least 1 age-appropriate bivalent mRNA COVID-19 vaccine dose. Depending on their COVID-19 vaccination history and history of immunocompromise, these children might also need additional doses* (1-3). Initial vaccine safety findings after primary series vaccination among children aged 6 months-5 years showed that transient local and systemic reactions were common whereas serious adverse events were rare (4). To characterize the safety of a third mRNA COVID-19 vaccine dose among children aged 6 months-5 years, CDC reviewed adverse events and health surveys reported to v-safe, a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor health after COVID-19 vaccination (https://vsafe.cdc.gov/en/) and the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system co-managed by CDC and the Food and Drug Administration (FDA) (https://vaers.hhs.gov/) (5). During June 17, 2022-May 7, 2023, approximately 495,576 children aged 6 months-4 years received a third dose (monovalent or bivalent) of Pfizer-BioNTech vaccine and 63,919 children aged 6 months-5 years received a third dose of Moderna vaccine.† A third mRNA COVID-19 vaccination was recorded for 2,969 children in v-safe; approximately 37.7% had no reported reactions, and among those for whom reactions were reported, most reactions were mild and transient. VAERS received 536 reports after a third dose of mRNA COVID-19 vaccine for children in these age groups; 98.5% of reports were nonserious and most (78.4%) were classified as a vaccination error.§ No new safety concerns were identified. Preliminary safety findings after a third dose of COVID-19 vaccine for children aged 6 months-5 years are similar to those after other doses. Health care providers can counsel parents and guardians of young children that most reactions reported after vaccination with Pfizer-BioNTech or Moderna vaccine were mild and transient and that serious adverse events are rare.

Computerization of the Work of General Practitioners: Mixed Methods Survey of Final-Year Medical Students in Ireland.

BACKGROUND: The potential for digital health technologies, including machine learning (ML)-enabled tools, to disrupt the medical profession is the subject of ongoing debate within biomedical informatics. OBJECTIVE: We aimed to describe the opinions of final-year medical students in Ireland regarding the potential of future technology to replace or work alongside general practitioners (GPs) in performing key tasks. METHODS: Between March 2019 and April 2020, using a convenience sample, we conducted a mixed methods paper-based survey of final-year medical students. The survey was administered at 4 out of 7 medical schools in Ireland across each of the 4 provinces in the country. Quantitative data were analyzed using descriptive statistics and nonparametric tests. We used thematic content analysis to investigate free-text responses. RESULTS: In total, 43.1% (252/585) of the final-year students at 3 medical schools responded, and data collection at 1 medical school was terminated due to disruptions associated with the COVID-19 pandemic. With regard to forecasting the potential impact of artificial intelligence (AI)/ML on primary care 25 years from now, around half (127/246, 51.6%) of all surveyed students believed the work of GPs will change minimally or not at all. Notably, students who did not intend to enter primary care predicted that AI/ML will have a great impact on the work of GPs. CONCLUSIONS: We caution that without a firm curricular foundation on advances in AI/ML, students may rely on extreme perspectives involving self-preserving optimism biases that demote the impact of advances in technology on primary care on the one hand and technohype on the other. Ultimately, these biases may lead to negative consequences in health care. Improvements in medical education could help prepare tomorrow's doctors to optimize and lead the ethical and evidence-based implementation of AI/ML-enabled tools in medicine for enhancing the care of tomorrow's patients.

eHealth interventions to support self-management: Perceptions and experiences of people with musculoskeletal disorders and physiotherapists - 'eHealth: It's TIME': A qualitative study.

BACKGROUND: There is increasing interest in the potential role of eHealth interventions to support self-management in people with musculoskeletal disorders (MSDs). The COVID-19 pandemic appears to have been a significant catalyst for the implementation of eHealth modalities into routine practice, providing a unique opportunity for real-world evaluation of this underutilized method of delivering physiotherapy. OBJECTIVE: To explore the perceptions of eHealth-mediated supported self-management from the perspective of people with MSDs and physiotherapists who work in this clinical area. METHODS: A qualitative interpretive descriptive approach was used. Semi-structured telephone interviews with 13 musculoskeletal physiotherapists and 13 people with musculoskeletal disorders were undertaken. Transcripts were analyzed using reflexive thematic analysis. RESULTS: Three main themes were identified: 1) Flexibility within a blended care model; 2) eHealth as a facilitator of self-management support; and 3) Technology: Getting it right. Participants expressed concerns about assessment and diagnosis, establishing a therapeutic relationship and felt eHealth should be reserved for follow-up purposes. There was a consistent view expressed that eHealth could facilitate aspects of self-management support. A lack of resources and suboptimal user experience remains a challenge. CONCLUSIONS: eHealth-mediated self-management support interventions were broadly acceptably, predominately as a follow-up option.

The multimorbidity collaborative medication review and decision making (MyComrade) study: a pilot cluster randomised trial in two healthcare systems.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. AIM: The pilot study aimed to assess the feasibility of a definitive trial of the MyComrade intervention across two healthcare systems (Republic of Ireland (ROI) and Northern Ireland (NI)). DESIGN: A pilot cluster-randomised controlled trial was conducted (clustered at general practice level), using specific progression criteria and a process evaluation framework. SETTING: General practices in the ROI and NI. PARTICIPANTS: Eligible practices were those in defined geographical areas who had GP's and Practice Based Pharmacists (PBP's) (in NI) willing to conduct medication reviews. Eligible patients were those aged 18 years and over, with multi morbidity and on ten or more medications. INTERVENTION: The MyComrade intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care, using a planned collaborative approach guided by an agreed checklist, within a specified timeframe. OUTCOME MEASURES: Feasibility outcomes, using pre-determined progression criteria, assessed practice and patient recruitment and retention and intervention acceptability and fidelity. Anonymised patient-related quantitative data, from practice medical records and patient questionnaires were collected at baseline, 4 and 8 months, to inform potential outcome measures for a definitive trial. These included (i) practice outcomes-completion of medication reviews; (ii) patient outcomes-treatment burden and quality of life; (iii) prescribing outcomes-number and changes of prescribed medications and incidents of potentially inappropriate prescribing; and (iv) economic cost analysis. The framework Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria and process evaluation was used to guide the collection and analysis of quantitative and qualitative data. RESULTS: The recruitment of practices (n = 15) and patients (n = 121, mean age 73 years and 51% female), representing 94% and 38% of a priori targets respectively, was more complex and took longer than anticipated; impacted by the global COVID-19 pandemic. Retention rates of 100% of practices and 85% of patients were achieved. Both practice staff and patients found the intervention acceptable and reported strong fidelity to the My Comrade intervention components. Some practice staff highlighted concerns such as poor communication of the reviews to patients, dissatisfaction regarding incentivisation and in ROI the sustainability of two GPs collaboratively conducting the medication reviews. Assessing outcomes from the collected data was found feasible and appropriate for a definitive trial. Two progression criteria met the 'Go' criterion (practice and patient retention), two met the 'Amend' criterion (practice recruitment and intervention implementation) and one indicated a 'Stop - unless changes possible' (patient recruitment). CONCLUSION: The MyComrade intervention was found to be feasible to conduct within two different healthcare systems. Recruitment of participants requires significant time and effort given the nature of this population and the pairing of GP and pharmacist may be more sustainable to implement in routine practice. TRIAL REGISTRATION: Registry: ISRCTN, ISRCTN80017020 ; date of confirmation 4/11/2019; retrospectively registered.

Atrial fibrillation (AF) pilot screening programme in primary care in Ireland: an implementation study protocol.

INTRODUCTION: Atrial fibrillation (AF) is a major risk factor for stroke. There is a fivefold increase in stroke risk in the presence of AF. The irregular beating of the heart enables blood stasis which allows clots to form. These can migrate to the brain causing a stroke. AF is common and its incidence increases with age. AF is often asymptomatic and early detection enables effective preventive treatment reducing stroke risk by up to two-thirds.Stroke contributes significantly to morbidity and mortality globally. In Ireland, it is the leading cause of acquired disability and second leading cause of death. The cost associated with stroke is significant. Stroke risk increases with age and is a public health priority.Internationally, there is consensus among experts that AF screening is valuable. In Ireland, the National Cardiovascular Policy recommended establishing a screening programme. However, there are many ways to screen for AF including pulse palpation, mobile ECG devices, 12-lead ECG and personal health monitoring devices.This study aims to investigate the acceptability, feasibility and impact of AF screening in primary care using a handheld mobile ECG device. METHODS AND ANALYSIS: General practitioners (GPs) and practice nurses in the South of Ireland will opportunistically screen patients aged ≥65 years for AF at routine consultation using a handheld one-lead ECG device, KardiaMobile. This study will screen up to 4000 patients. Blood pressure and smoking status will be checked concurrently. A mixed-method evaluation will be undertaken including a partial economic evaluation. Anonymised data will be collected from participating practices and qualitative interviews will be conducted with GP, nurse and patient participants. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Clinical Research Ethics Committee in University College Cork. Dissemination will involve publication in peer-reviewed journals and presentation at national and international conferences.

COVID-19 community assessment hubs in Ireland-the experience of clinicians.

BACKGROUND: COVID-19 required rapid innovation in health systems, in the context of an infection which placed healthcare professionals at high risk; general practice has been a key component of that innovative response. In Ireland, GPs were asked to work in a network of community assessment hubs. A focused training programme in infection control procedures/clinical use of personal protective equipment (PPE) was rapidly developed in advance. University departments of general practice were asked to develop and deliver that training. AIM: The aim of this article is to describe infection control procedure training in Ireland, the uptake by GPs and the initial experience of GPs working in this unusual environment. DESIGN AND SETTING: Two anonymous cross-sectional online surveys are sent to participants in training courses. METHOD: Survey 1 followed completion of training; survey 2 followed establishment of the hubs. RESULTS: Six hundred seventy-five participants (including 439 GPs, 156 GP registrars) took part in the training. Two hundred thirty-nine (50.3%) out of four hundred seventy-five responded to Survey 1-over 95% reported an increase in confidence in the use of PPE. Two hundred ten (44.2%) out of four hundred seventy-five participants responded to Survey 2; 195 had completed hub shifts. Younger, female GPs predominated. Very high levels of infection control procedures were reported. Participants commented positively on teamworking, environment and systems. However, 'real-time' ambulance service data suggest the peak of the surge may have passed by the time the hubs were established. CONCLUSION: Academic departments, GPs and the Irish health system collaborated effectively to respond to the need for community assessment of COVID-19 patients.