National safety monitoring of vaccines from the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), 2018-2019.

Background: The Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) is a comprehensive vaccine safety surveillance system that includes both passive and active surveillance of vaccines administered in Canada. This work presents a summary of adverse events following immunization (AEFI) nationally for 2018 and 2019. Methods: Data extracted from CAEFISS included all AEFI reports received by the Public Health Agency of Canada by April 30, 2022, for vaccines marketed in Canada and administered between January 1, 2018, and December 31, 2019. Descriptive statistics were conducted on AEFI reports by type of surveillance program (i.e., active vs. passive), AEFIs, demographics, healthcare utilization, outcome, seriousness of adverse events and type of vaccine. Results: Between 2018 and 2019, 5,875 AEFI reports were received from across Canada. The average annual AEFI reporting rate was 10.9/100,000 doses distributed in Canada for vaccines administered during 2018-2019 and was found to be inversely proportional to age. The majority of reports (91%) were non-serious events, involving vaccination site reactions, rash and allergic events. Overall, there were 511 serious adverse event reports during 2018-2019. Of the serious adverse event reports, the most common primary AEFIs were anaphylaxis followed by seizure. There were no unexpected vaccine safety issues identified or increases in frequency or severity of adverse events. Conclusion: Canada's continuous monitoring of the safety of marketed vaccines during 2018-2019 did not identify any increase in the frequency or severity of AEFIs, previously unknown AEFIs, or areas that required further investigation or research.

Canadian vaccine safety surveillance reports following immunization with seasonal influenza vaccines, 2021-2022.

Background: Seasonal influenza vaccines (SIV) authorized for use in Canada have all undergone rigorous regulatory assessments for safety and effectiveness. Serious adverse events following immunization (AEFI) can occur, though they are rare. Continuous safety surveillance of vaccines during the post-marketing phase is a critical component of vaccination programs. This enables the detection of rare, late onset, or unexpected adverse events. An updated safety summary following the introduction of any new vaccines and/or formulations to immunization programs is necessary for refining the risk-benefit profile of a specific vaccine and maintaining public confidence. Here we provide an updated safety summary for SIVs distributed during the 2021/2022 influenza season from AEFI reports submitted to the Canadian Adverse Event Following Immunization Surveillance System (CAEFISS) and the Canadian Vigilance Database (CVD). Methods: We searched CAEFISS and CVD for individuals who were vaccinated with a SIV between October 1, 2021, and March 31, 2022. Descriptive statistics were calculated, including median age of vaccinated individuals, vaccines co-administered with SIV, and the most frequently reported AEFIs. Crude AEFI reporting rates were calculated by severity of the AEFI report, and SIV-type using doses distributed data. Medical reviews were conducted for reports including death, serious events (or outcomes) after SIV were administered alone, and selected adverse events (i.e., anaphylaxis, Guillain-Barré syndrome, febrile seizures, oculo-respiratory syndrome). Disproportionality analysis was used to identify potential safety signals among SIV and AEFI pairs. Results: There were 448 AEFI reports, with most AEFI classified as non-serious events (84.2%). The majority of reports described vaccination in adults at least 65 years of age (38.6%). The most frequently reported AEFIs were vaccination site pain, urticaria, pyrexia and rash. Medical review of AEFI reports did not find any evidence that reported deaths were related to vaccination with SIV. Among serious reports, nervous system disorders were the most commonly reported medical conditions. A higher number of events related to vaccination errors were also identified using disproportionality analysis. Conclusion: Findings from our analysis of reports to CAEFISS and CVD following vaccination with SIV are consistent with the known safety profile of SIVs distributed during the 2021/2022 influenza season. The majority of reports were non-serious with the most common AEFI symptoms occurring at the vaccination site or systemic symptoms that were self-limiting. The majority of vaccination error reports involved the administration of the vaccine at an inappropriate site, although no serious AEFIs were reported.

HIV in Canada-surveillance report, 2019.

BACKGROUND: Human immunodeficiency virus (HIV) is a global public health issue. HIV has been nationally notifiable in Canada since 1985. The Public Health Agency of Canada (PHAC) monitors trends in new HIV diagnoses. OBJECTIVES: The objective of this surveillance report is to provide an overview of the epidemiology of reported HIV cases in 2019 in Canada. The report highlights 10-year trends (2010-2019). Data on HIV diagnosed through Immigration Medical Exams (IME) and trends in perinatal transmission of HIV are also presented. METHODS: PHAC monitors HIV through the HIV/AIDS Surveillance System, a passive, case-based system that collates non-nominal data submitted voluntarily by all Canadian provinces and territories. Descriptive analyses were conducted on national data. IME data were obtained from Immigration, Refugees and Citizenship Canada (IRCC), and data on HIV-exposed pregnancies were obtained through the Canadian Perinatal HIV Surveillance Program. RESULTS: In 2019, a total of 2,122 HIV diagnoses were reported in Canada (5.6 per 100,000 population). Saskatchewan reported the highest provincial diagnosis rate at 16.9 per 100,000 population. The 30 to 39-year age group had the highest HIV diagnosis rate at 12.7 per 100,000 population. While the rates for both males and females fluctuated in the past decade, since 2010 the rates among males decreased overall, while the rate among females increased slightly. As in previous years, the diagnosis rate for males in 2019 was higher than that for females (7.9 versus 3.4 per 100,000 population, respectively). The highest proportion of all reported adult cases with known exposure were gay, bisexual and other men who have sex with men (gbMSM, 39.7%), followed by cases attributed to heterosexual contact (28.3%) and among people who inject drugs (PWID, 21.5%). The number of migrants who tested positive for HIV during an IME conducted in Canada was 626. The one documented perinatal HIV transmission related to a mother who had not received antepartum or intrapartum antiretroviral therapy prophylaxis. CONCLUSION: The number and rate of reported HIV cases in Canada has remained relatively stable over the last decade, with minor year-to-year variations. As in previous years, the gbMSM and PWID populations represent a high proportion of HIV diagnoses, although a sizable number of cases were attributed to heterosexual contact. It is important to routinely monitor trends in HIV in light of pan-Canadian commitments to reduce the health impact of sexually transmitted and blood-borne infections by 2030.

A Pilot Study Evaluating the Effectiveness of the 5As of Healthy Pregnancy Weight Gain.

INTRODUCTION: Gestational weight gain (GWG) outside of the 2009 Institute of Medicine guidelines may be harmful to women and their fetuses. Prenatal health care providers (HCPs) are important sources of health information, but not all discuss GWG with their patients. The Canadian Obesity Network's 5As (ask, assess, advise, agree, and assist) of Healthy Pregnancy Weight Gain (5As) is a tool developed to help HCPs counsel their patients on GWG. The main objective of this study was to evaluate the impact of the 5As tool on patient perceptions of GWG discussions with their HCP and to identify suggestions to improve the tool. METHODS: A quasiexperimental study design was conducted whereby HCPs were trained in using the 5As tool (intervention). Patients were then queried at baseline and postintervention using an electronic questionnaire measuring patient-perceived 5As counseling. Inclusion criteria for pregnant women were (1) currently attending their first appointment with participating HCPs, (2) English-speaking, and (3) over 18 years of age. RESULTS: One hundred pregnant women (50 baseline, 50 postintervention) and 15 HCPs (11 midwives, 4 obstetricians) participated. Participants receiving care from 5As-trained HCPs reported scores twice as high (P = .047) in being asked about and were approximately 3 times more likely to be advised an exact amount of target weight gain (P = .03). HCPs suggested improving patient handouts and HCP education on GWG guidelines as well as reducing the content presented in the 5As tool. DISCUSSION: The 5As Tool is effective at initiating HCP-mediated GWG counseling; further research is needed to examine the usefulness of the 5As in clinical practice throughout the length of a full pregnancy. Whether the uptake of the 5As tool contributes to prenatal behavior change remains to be established. Future steps include modifying the tool based on HCP feedback, the development of novel knowledge translation tools, and improved HCP and patient education.

Gestational weight gain counselling gaps as perceived by pregnant women and new mothers: Findings from the electronic maternal health survey.

PROBLEM: Too much or too little gestational weight gain (GWG) can negatively impact maternal and fetal health, according to Institute of Medicine Guidelines. BACKGROUND: Health care providers are key players in providing reliable evidence-informed prenatal advice related to appropriate GWG. However, there appears to be inconsistent GWG communication among healthcare providers during prenatal care. AIM: To determine pregnant women and new mothers' perceptions of healthcare provider GWG and dietary counselling during the pregnancy period. METHODS: A reliable and validated cross-sectional electronic survey was administered to currently pregnant women and women who had recently given birth. The web-based questionnaire was self-administered and took 10-25min. FINDINGS: A total of 1507 eligible women participated in the survey. More than half (57%) reported that their healthcare provider talked to them about personal weight gain limits. Of these participants, about a third (34%) of participants were counselled regularly at each or most visits. Among the women that were not counselled on personal GWG limits, over half (56%) reported that healthcare provider guidance would have been helpful to achieve their target weight. Less than half (45%) of participants reported that their healthcare providers discussed dietary requirements or changes in pregnancy. DISCUSSION: These findings highlight areas for improvement in prenatal dialogue, which can support better outcomes for both mother and baby. CONCLUSION: A better understanding of pregnant and mothers' perceptions about weight and diet counselling is needed to understand what may need greater attention and clarification and to improve such dialogue.

High maternal self-efficacy is associated with meeting Institute of Medicine gestational weight gain recommendations.

OBJECTIVE: Fetal exposure to an intrauterine environment affected by maternal obesity and excessive gestational weight gain increases the likelihood of infants born large for gestational age and childhood obesity. This study examined behavioural factors and lifestyle practices associated with women's perceived attainability of meeting the 2009 Institute of Medicine (IOM) weight gain guidelines. METHODS: Cross-sectional data were collected from pregnant (n = 320) and postpartum (n = 1179) women who responded to the validated Canadian Electronic Maternal (EMat) health survey. Consenting women completed the survey through REDCap™ a secure, web-based data capture platform. Multiple logistic regression analyses were used to evaluate correlates associated with meeting or not meeting IOM recommendations. Odds ratios (ORs) were adjusted for relevant behavioural and sociodemographic covariates. RESULTS: There were no significant differences between adjusted and unadjusted ORs for self-efficacy, barriers, and facilitators to weight gain during pregnancy. Women who reported worry regarding weight gain were significantly less likely to meet IOM guidelines (OR = 0.48, 95% CI = 0.33-0.69). Perceived controllability of behaviour was significantly associated with meeting IOM guidelines. An internal locus of control for weight gain was associated with an increased odds of meeting guidelines when women perceived to be in control of their weight gain (OR = 1.75, 95% CI = 1.29-2.37), healthy and exercised (OR = 1.91, 95% CI = 1.34-2.71), and when no barriers to healthy weight gain were perceived (OR = 1.43, 95% CI = 1.04-1.95); whereas, an external locus of control in which women viewed weight gain as beyond their control, was associated with a significantly reduced odds of achieving guidelines (OR = 0.58, 95% CI = 0.39-0.88). CONCLUSIONS: Self-efficacy and perceived controllability of behaviour are key factors to consider when developing pregnancy-specific interventions to help women achieve guideline-concordant weight gain and ensure the downstream health of both mother and infant.

Impact of prenatal exercise on maternal harms, labour and delivery outcomes: a systematic review and meta-analysis.

OBJECTIVE: To perform a systematic review of the relationships between prenatal exercise and maternal harms including labour/delivery outcomes. DESIGN: Systematic review with random effects meta-analysis and meta-regression. DATASOURCES: Online databases were searched up to 6 January 2017. STUDY ELIGIBILITY CRITERIA: Studies of all designs were included (except case studies) if they were published in English, Spanish or French and contained information on the population (pregnant women without contraindication to exercise), intervention (subjective or objective measures of frequency, intensity, duration, volume or type of exercise), comparator (no exercise or different frequency, intensity, duration, volume and type of exercise, alone ["exercise-only"] or in combination with other intervention components [e.g., dietary; "exercise + co-intervention"]) and outcome (preterm/prelabour rupture of membranes, caesarean section, instrumental delivery, induction of labour, length of labour, vaginal tears, fatigue, injury, musculoskeletal trauma, maternal harms (author defined) and diastasis recti). RESULTS: 113 studies (n=52 858 women) were included. 'Moderate' quality evidence from exercise-only randomised controlled trials (RCTs) indicated a 24% reduction in the odds of instrumental delivery in women who exercised compared with women who did not (20 RCTs, n=3819; OR 0.76, 95% CI 0.63 to 0.92, I 2= 0 %). The remaining outcomes were not associated with exercise. Results from meta-regression did not identify a dose-response relationship between frequency, intensity, duration or volume of exercise and labour and delivery outcomes. SUMMARY/CONCLUSIONS: Prenatal exercise reduced the odds of instrumental delivery in the general obstetrical population. There was no relationship between prenatal exercise and preterm/prelabour rupture of membranes, caesarean section, induction of labour, length of labour, vaginal tears, fatigue, injury, musculoskeletal trauma, maternal harms and diastasis recti.

Effectiveness of exercise interventions in the prevention of excessive gestational weight gain and postpartum weight retention: a systematic review and meta-analysis.

OBJECTIVE: Gestational weight gain (GWG) has been identified as a critical modifier of maternal and fetal health. This systematic review and meta-analysis aimed to examine the relationship between prenatal exercise, GWG and postpartum weight retention (PPWR). DESIGN: Systematic review with random effects meta-analysis and meta-regression. Online databases were searched up to 6 January 2017. STUDY ELIGIBILITY CRITERIA: Studies of all designs in English, Spanish or French were eligible (except case studies and reviews) if they contained information on the population (pregnant women without contraindication to exercise), intervention (frequency, intensity, duration, volume or type of exercise, alone ["exercise-only"] or in combination with other intervention components [eg, dietary; "exercise + co-intervention"]), comparator (no exercise or different frequency, intensity, duration, volume or type of exercise) and outcomes (GWG, excessive GWG (EGWG), inadequate GWG (IGWG) or PPWR). RESULTS: Eighty-four unique studies (n=21 530) were included. 'Low' to 'moderate' quality evidence from randomised controlled trials (RCTs) showed that exercise-only interventions decreased total GWG (n=5819; -0.9 kg, 95% CI -1.23 to -0.57 kg, I2=52%) and PPWR (n=420; -0.92 kg, 95% CI -1.84 to 0.00 kg, I2=0%) and reduced the odds of EGWG (n=3519; OR 0.68, 95% CI 0.57 to 0.80, I2=12%) compared with no exercise. 'High' quality evidence indicated higher odds of IGWG with prenatal exercise-only (n=1628; OR 1.32, 95% CI 1.04 to 1.67, I2=0%) compared with no exercise. CONCLUSIONS: Prenatal exercise reduced the odds of EGWG and PPWR but increased the risk of IGWG. However, the latter result should be interpreted with caution because it was based on a limited number of studies (five RCTs).

Prenatal exercise for the prevention of gestational diabetes mellitus and hypertensive disorders of pregnancy: a systematic review and meta-analysis.

OBJECTIVE: Gestational diabetes mellitus (GDM), gestational hypertension (GH) and pre-eclampsia (PE) are associated with short and long-term health issues for mother and child; prevention of these complications is critically important. This study aimed to perform a systematic review and meta-analysis of the relationships between prenatal exercise and GDM, GH and PE. DESIGN: Systematic review with random effects meta-analysis and meta-regression. DATA SOURCES: Online databases were searched up to 6 January 2017. STUDY ELIGIBILITY CRITERIA: Studies of all designs were included (except case studies) if published in English, Spanish or French, and contained information on the Population (pregnant women without contraindication to exercise), Intervention (subjective or objective measures of frequency, intensity, duration, volume or type of exercise, alone ["exercise-only"] or in combination with other intervention components [e.g., dietary; "exercise + co-intervention"]), Comparator (no exercise or different frequency, intensity, duration, volume and type of exercise) and Outcomes (GDM, GH, PE). RESULTS: A total of 106 studies (n=273 182) were included. 'Moderate' to 'high'-quality evidence from randomised controlled trials revealed that exercise-only interventions, but not exercise+cointerventions, reduced odds of GDM (n=6934; OR 0.62, 95% CI 0.52 to 0.75), GH (n=5316; OR 0.61, 95% CI 0.43 to 0.85) and PE (n=3322; OR 0.59, 95% CI 0.37 to 0.9) compared with no exercise. To achieve at least a 25% reduction in the odds of developing GDM, PE and GH, pregnant women need to accumulate at least 600 MET-min/week of moderate-intensity exercise (eg, 140 min of brisk walking, water aerobics, stationary cycling or resistance training). SUMMARY/CONCLUSIONS: In conclusion, exercise-only interventions were effective at lowering the odds of developing GDM, GH and PE.

Impact of prenatal exercise on neonatal and childhood outcomes: a systematic review and meta-analysis.

OBJECTIVE: We aimed to identify the relationship between maternal prenatal exercise and birth complications, and neonatal and childhood morphometric, metabolic and developmental outcomes. DESIGN: Systematic review with random-effects meta-analysis and meta-regression. DATA SOURCES: Online databases were searched up to 6 January 2017. STUDY ELIGIBILITY CRITERIA: Studies of all designs were eligible (except case studies and reviews) if published in English, Spanish or French, and contained information on the relevant population (pregnant women without contraindication to exercise), intervention (subjective/objective measures of frequency, intensity, duration, volume or type of exercise, alone ('exercise-only') or in combination with other intervention components (eg, dietary; 'exercise+cointervention')), comparator (no exercise or different frequency, intensity, duration, volume, type or trimester of exercise) and outcomes (preterm birth, gestational age at delivery, birth weight, low birth weight (<2500 g), high birth weight (>4000 g), small for gestational age, large for gestational age, intrauterine growth restriction, neonatal hypoglycaemia, metabolic acidosis (cord blood pH, base excess), hyperbilirubinaemia, Apgar scores, neonatal intensive care unit admittance, shoulder dystocia, brachial plexus injury, neonatal body composition (per cent body fat, body weight, body mass index (BMI), ponderal index), childhood obesity (per cent body fat, body weight, BMI) and developmental milestones (including cognitive, psychosocial, motor skills)). RESULTS: A total of 135 studies (n=166 094) were included. There was 'high' quality evidence from exercise-only randomised controlled trials (RCTs) showing a 39% reduction in the odds of having a baby >4000 g (macrosomia: 15 RCTs, n=3670; OR 0.61, 95% CI 0.41 to 0.92) in women who exercised compared with women who did not exercise, without affecting the odds of growth-restricted, preterm or low birth weight babies. Prenatal exercise was not associated with the other neonatal or infant outcomes that were examined. CONCLUSIONS: Prenatal exercise is safe and beneficial for the fetus. Maternal exercise was associated with reduced odds of macrosomia (abnormally large babies) and was not associated with neonatal complications or adverse childhood outcomes.

Prenatal exercise (including but not limited to pelvic floor muscle training) and urinary incontinence during and following pregnancy: a systematic review and meta-analysis.

OBJECTIVE: To examine the relationships between prenatal physical activity and prenatal and postnatal urinary incontinence (UI). DESIGN: Systematic review with random effects meta-analysis and meta-regression. DATA SOURCES: Online databases were searched up to 6 January 2017. STUDY ELIGIBILITY CRITERIA: Studies of all designs were included (except case studies) if they were published in English, Spanish or French and contained information on the Population (pregnant women without contraindication to exercise), Intervention (subjective or objective measures of frequency, intensity, duration, volume or type of exercise, alone ["exercise-only"] or in combination with other intervention components [e.g., dietary; "exercise + co-intervention"]), Comparator (no exercise or different frequency, intensity, duration, volume and type of exercise) and Outcome (prenatal or postnatal UI). RESULTS: 24 studies (n=15 982 women) were included. 'Low' to 'moderate' quality evidence revealed prenatal pelvic floor muscle training (PFMT) with or without aerobic exercise decreased the odds of UI in pregnancy (15 randomised controlled trials (RCTs), n=2764 women; OR 0.50, 95% CI 0.37 to 0.68, I2=60%) and in the postpartum period (10 RCTs, n=1682 women; OR 0.63, 95% CI 0.51, 0.79, I2=0%). When we analysed the data by whether women were continent or incontinent prior to the intervention, exercise was beneficial at preventing the development of UI in women with continence, but not effective in treating UI in women with incontinence. There was 'low' quality evidence that prenatal exercise had a moderate effect in the reduction of UI symptom severity during (five RCTs, standard mean difference (SMD) -0.54, 95% CI -0.88 to -0.20, I2=64%) and following pregnancy (three RCTs, 'moderate' quality evidence; SMD -0.54, 95% CI -0.87 to -0.22, I2=24%). CONCLUSION: Prenatal exercise including PFMT reduced the odds and symptom severity of prenatal and postnatal UI. This was the case for women who were continent before the intervention. Among women who were incontinent during pregnancy, exercise training was not therapeutic.

Inconsistent Weight Communication Among Prenatal Healthcare Providers and Patients: A Narrative Review.

IMPORTANCE: Gestational weight gain (GWG) is an independent and modifiable factor for a healthy pregnancy. Gestational weight gain above or below the Institute of Medicine Guidelines has been shown to impact both maternal and fetal health (eg, gestational diabetes, hypertension, downstream obesity). Healthcare providers (HCPs) have the potential to be reliable sources of evidence-based weight information and advice during pregnancy. OBJECTIVE: The aim of this study was to summarize the literature assessing GWG discussions between patients and their HCPs in a clinical setting to better understand the knowledge that is currently being exchanged. EVIDENCE ACQUISITION: A literature review was conducted by searching Ovid Medline, CINAHL, and Embase databases. All relevant primary research articles in English that assessed GWG discussions were included, whereas intervention studies were excluded. RESULTS: A total of 54 articles were included in this review. Although the overall prevalence and content of GWG counseling varied between studies, counseling was often infrequent and inaccurate. Healthcare providers tended to focus more on women experiencing obesity and excessive GWG, as opposed to the other body mass index categories or inadequate GWG. Women of higher socioeconomic status, older age, nulliparous, history of dieting, low physical activity, and those categorized as overweight/obese were more likely to receive GWG advice. Patients also reported receiving conflicting facts between different HCP disciplines. CONCLUSIONS: The evidence regarding GWG counseling in prenatal care remains variable, with discrepancies between geographic regions, patient populations, and HCP disciplines. RELEVANCE: Healthcare providers should counsel their pregnant patients on GWG with advice that is concordant with the Institute of Medicine Guidelines.