IntroductionThere 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 analysisA 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 disseminationThis 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.
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 measuresThe 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. ResultsOf 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 radiologistinterpreted 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. ConclusionFollowing 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.This article has been peer reviewed. Cet article a fait l'objet d'une révision par des pairs.
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