COVID-19 vaccine reactogenicity among participants enrolled in the GENCOV study.

BACKGROUND: GENCOV is a prospective, observational cohort study of COVID-19-positive adults. Here, we characterize and compare side effects between COVID-19 vaccines and determine whether reactogenicity is exacerbated by prior SARS-CoV-2 infection. METHODS: Participants were recruited across Ontario, Canada. Participant-reported demographic and COVID-19 vaccination data were collected using a questionnaire. Multivariable logistic regression was performed to assess whether vaccine manufacturer, type, and previous SARS-CoV-2 infection are associated with reactogenicity. RESULTS: Responses were obtained from n = 554 participants. Tiredness and localized side effects were the most common reactions across vaccine doses. For most participants, side effects occurred and subsided within 1-2 days. Recipients of Moderna mRNA and AstraZeneca vector vaccines reported reactions more frequently compared to recipients of a Pfizer-BioNTech mRNA vaccine. Previous SARS-CoV-2 infection was independently associated with developing side effects. CONCLUSIONS: We provide evidence of relatively mild and short-lived reactions reported by participants who have received approved COVID-19 vaccines.

Characterizing Risk Factors for Hospitalization and Clinical Characteristics in a Cohort of COVID-19 Patients Enrolled in the GENCOV Study.

The GENCOV study aims to identify patient factors which affect COVID-19 severity and outcomes. Here, we aimed to evaluate patient characteristics, acute symptoms and their persistence, and associations with hospitalization. Participants were recruited at hospital sites across the Greater Toronto Area in Ontario, Canada. Patient-reported demographics, medical history, and COVID-19 symptoms and complications were collected through an intake survey. Regression analyses were performed to identify associations with outcomes including hospitalization and COVID-19 symptoms. In total, 966 responses were obtained from 1106 eligible participants (87% response rate) between November 2020 and May 2022. Increasing continuous age (aOR: 1.05 [95%CI: 1.01-1.08]) and BMI (aOR: 1.17 [95%CI: 1.10-1.24]), non-White/European ethnicity (aOR: 2.72 [95%CI: 1.22-6.05]), hypertension (aOR: 2.78 [95%CI: 1.22-6.34]), and infection by viral variants (aOR: 5.43 [95%CI: 1.45-20.34]) were identified as risk factors for hospitalization. Several symptoms including shortness of breath and fever were found to be more common among inpatients and tended to persist for longer durations following acute illness. Sex, age, ethnicity, BMI, vaccination status, viral strain, and underlying health conditions were associated with developing and having persistent symptoms. By improving our understanding of risk factors for severe COVID-19, our findings may guide COVID-19 patient management strategies by enabling more efficient clinical decision making.

Public knowledge of SARS-CoV-2 serological and viral lineage laboratory testing and result interpretation: A GENCOV study cross-sectional survey.

OBJECTIVES: Concepts related to SARS-CoV-2 laboratory testing and result interpretation can be challenging to understand. A cross-sectional survey of COVID-19 positive adults residing in Ontario, Canada was conducted to explore how well people understand SARS-CoV-2 laboratory tests and their associated results. DESIGN AND METHODS: Participants were recruited through fliers or by prospective recruitment of outpatients and hospitalized inpatients with COVID-19. Enrolled participants included consenting adults with a positive SARS-CoV-2 polymerase chain reaction test result. An 11-item questionnaire was developed by researchers, nurses, and physicians in the study team and was administered online between April 2021 to May 2022 upon enrolment into the study. RESULTS: Responses were obtained from 940 of 1106 eligible participants (85% participation rate). Most respondents understood 1) that antibody results should not influence adherence to social distancing measures (n = 602/888, 68%), 2) asymptomatic SARS-CoV-2 infection following test positivity (n = 698/888, 79%), 3) serological test sensitivity in relation to post-infection timeline (n = 540/891, 61%), and 4) limitations of experts' knowledge related to SARS-CoV-2 serology (n = 693/887, 78%). Conversely, respondents demonstrated challenges understanding 1) conflicting molecular and serological test results and their relationship with immune protection (n = 162/893, 18%) and 2) the impact of SARS-CoV-2 variants on vaccine effectiveness (n = 235/891, 26%). Analysis of responses stratified by sociodemographic variables identified that respondents who were either: 1) female, 2) more educated, 3) aged 18-44, 4) from a high-income household, or 5) healthcare workers responded expectedly more often. CONCLUSIONS: We have highlighted concepts related to SARS-CoV-2 laboratory tests and associated results which may be challenging to understand. The findings of this study enable us to identify 1) misconceptions related to various SARS-CoV-2 test results, 2) groups of individuals at risk, and 3) strategies to improve people's understanding of their test results.

Genome screening, reporting, and genetic counseling for healthy populations.

Rapid advancements of genome sequencing (GS) technologies have enhanced our understanding of the relationship between genes and human disease. To incorporate genomic information into the practice of medicine, new processes for the analysis, reporting, and communication of GS data are needed. Blood samples were collected from adults with a PCR-confirmed SARS-CoV-2 (COVID-19) diagnosis (target N = 1500). GS was performed. Data were filtered and analyzed using custom pipelines and gene panels. We developed unique patient-facing materials, including an online intake survey, group counseling presentation, and consultation letters in addition to a comprehensive GS report. The final report includes results generated from GS data: (1) monogenic disease risks; (2) carrier status; (3) pharmacogenomic variants; (4) polygenic risk scores for common conditions; (5) HLA genotype; (6) genetic ancestry; (7) blood group; and, (8) COVID-19 viral lineage. Participants complete pre-test genetic counseling and confirm preferences for secondary findings before receiving results. Counseling and referrals are initiated for clinically significant findings. We developed a genetic counseling, reporting, and return of results framework that integrates GS information across multiple areas of human health, presenting possibilities for the clinical application of comprehensive GS data in healthy individuals.

Point-of-care ultrasound for evaluation of vaginal bleeding or abdominal pain in early pregnancy: Use by family physicians following focused training and certification.

OBJECTIVE: To evaluate the use of point-of-care ultrasound (POCUS) for the assessment of patients experiencing first-trimester bleeding or abdominal pain by family physicians working in family medicine clinics following first-trimester POCUS training and certification. DESIGN: Multisite, retrospective chart review. SETTING: Two hospital-affiliated academic family medicine clinics in Toronto, Ont. PARTICIPANTS: Twelve family physicians who completed a first-trimester POCUS training and certification course. MAIN OUTCOME MEASURES: The primary outcome was the proportion of family physicians using POCUS during their evaluations of patients in the first trimester of pregnancy in the 6 months following the FPs' successful completion of the Family Medicine Obstetrical Ultrasound (FaMOUS) course. Secondary outcomes included indications for POCUS use, diagnostic accuracy of POCUS compared with radiologist-interpreted ultrasound, pregnancy outcomes, and emergency department visits within 10 days of the index family medicine clinic visit. RESULTS: Of the 12 certified family physicians, 7 (58.3%) used POCUS during their assessments of first-trimester patients during the study period. The FPs used POCUS with 56 patients for the following indications: 11 (19.6%) had only vaginal bleeding, 5 (8.9%) had only abdominal pain, and 8 (14.3%) had both vaginal bleeding and abdominal pain; the indication for 32 patients (57.1%) was unclear. Forty-six patients (82.1%) underwent a subsequent radiologist-interpreted ultrasound within 10 days of the index POCUS test. Compared with radiologist-interpreted ultrasound, POCUS had a sensitivity of 91.3% (95% CI 79.2% to 97.6%) for documenting intrauterine pregnancy and a sensitivity of 81.4% (95% CI 66.6% to 91.6%) for documenting the presence of fetal cardiac activity. CONCLUSION: Following a first-trimester POCUS certification course, family physicians used POCUS for the assessment of first-trimester patients with varying frequency and for indications other than vaginal bleeding or abdominal pain. Further study is needed to assess the clinical impact of office-based POCUS, unforeseen barriers and facilitators to its use, and patient and provider preferences.

Multiple symptoms and health anxiety in primary care: a qualitative study of tensions and collaboration between patients and family physicians.

BACKGROUND: Patients with multiple, persistent symptoms and health anxiety often report poor health outcomes. Patients who are difficult to reassure are challenging for family physicians. The therapeutic alliance between a physician and a patient can influence the prognosis of these patients. Optimising the quality of the physician-patient alliance may depend on a better understanding of the interpersonal processes that influence this relationship. OBJECTIVE: The purpose of this study is to understand the experiences of patients who experience multiple persistent symptoms or high health anxiety and their physicians when they interact. DESIGN, PARTICIPANTS AND SETTING: A qualitative study was conducted using grounded theory of 18 patients, purposively sampled to select patients who reported high physical symptom severity, high health anxiety or both, and 7 family physicians in the same clinic. This study was conducted at a family medicine clinic in a teaching hospital. RESULTS: A model of interpersonal tension and collaboration for patients and physicians in primary care was developed. Helpful attitudes and actions as well as troublesome topics influence crucial dilemmas between patients and physicians. These dilemmas include if patients feel heard and validated and the alignment of goals and mutual respect of expertise and experience between patients and physicians. These experiences contribute to a constructive collaboration and in turn positive outcomes. CONCLUSIONS: This model of patient-physician interaction may facilitate providers to turn their attention away from the contentious topics and towards actions and attitudes that promote beneficial outcomes.

Implementation of serological and molecular tools to inform COVID-19 patient management: protocol for the GENCOV prospective cohort study.

INTRODUCTION: There is considerable variability in symptoms and severity of COVID-19 among patients infected by the SARS-CoV-2 virus. Linking host and virus genome sequence information to antibody response and biological information may identify patient or viral characteristics associated with poor and favourable outcomes. This study aims to (1) identify characteristics of the antibody response that result in maintained immune response and better outcomes, (2) determine the impact of genetic differences on infection severity and immune response, (3) determine the impact of viral lineage on antibody response and patient outcomes and (4) evaluate patient-reported outcomes of receiving host genome, antibody and viral lineage results. METHODS AND ANALYSIS: A prospective, observational cohort study is being conducted among adult patients with COVID-19 in the Greater Toronto Area. Blood samples are collected at baseline (during infection) and 1, 6 and 12 months after diagnosis. Serial antibody titres, isotype, antigen target and viral neutralisation will be assessed. Clinical data will be collected from chart reviews and patient surveys. Host genomes and T-cell and B-cell receptors will be sequenced. Viral genomes will be sequenced to identify viral lineage. Regression models will be used to test associations between antibody response, physiological response, genetic markers and patient outcomes. Pathogenic genomic variants related to disease severity, or negative outcomes will be identified and genome wide association will be conducted. Immune repertoire diversity during infection will be correlated with severity of COVID-19 symptoms and human leucocyte antigen-type associated with SARS-CoV-2 infection. Participants can learn their genome sequencing, antibody and viral sequencing results; patient-reported outcomes of receiving this information will be assessed through surveys and qualitative interviews. ETHICS AND DISSEMINATION: This study was approved by Clinical Trials Ontario Streamlined Ethics Review System (CTO Project ID: 3302) and the research ethics boards at participating hospitals. Study findings will be disseminated through peer-reviewed publications, conference presentations and end-users.

Do Not Waste a Crisis: Physician Engagement during the COVID-19 Pandemic.

Physician engagement is an important factor in improving care quality and patient safety, but engaging physicians is not easy. Winston Churchill's famous assertion about never wasting a crisis has defined the approach taken by many leaders during the COVID-19 pandemic. This paper describes three case studies of successful physician engagement across the continuum of acute care, chronic care and primary care settings during the pandemic. These examples offer insights on physician engagement within unique settings by leveraging intrinsic motivators and Spurgeon's model of medical engagement.

Childhood adversity and attachment anxiety predict adult symptom severity and health anxiety.

BACKGROUND: Childhood adversity is associated with somatization, including physical symptom burden and health anxiety. Attachment theory offers a developmental framework to understand adult somatization, as attachment phenomena are theoretically and empirically related to physiological regulation, affect regulation, and childhood adversity, all of which are relevant to somatization. OBJECTIVE: The purpose of this study was to identify the pathways by which childhood adversity and attachment insecurity influence physical symptom burden and health anxiety in adults. PARTICIPANTS AND SETTING: Three hundred and fifty-one family medicine patients from a teaching hospital in Toronto, Canada. METHODS: A cross-sectional survey study was conducted to assess adverse childhood experiences, attachment insecurity, health anxiety and physical symptom severity in primary care patients. Path Analysis using structural equation modeling (AMOS V.26, IBM, 2019) was used to test the model in which childhood adversity, attachment anxiety, attachment avoidance, symptom severity interact to influence health anxiety. RESULTS: The majority of the participants were white (66%), had completed post-secondary education (68%), and reported themselves to be in very good to excellent health (62%). Childhood adversity, attachment anxiety, attachment avoidance, health anxiety and symptom severity are all significantly correlated (ranges of rs = 0.29 to 0.63). Childhood adversity has a significant indirect effect on health anxiety with attachment anxiety and symptom severity as serial mediators (ßindirect = 0.237, p = .001 and ßdirect = 0.065, p = .244). CONCLUSIONS: Overall, this model extends our understanding of the processes underlying adult somatization. Findings support that childhood adversity and attachment anxiety are predictors of symptom severity and health anxiety.