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Potential conflicts of interest in vaccine research can lead to negative consequences that undermine public trust and thereby put communities at risk. However, collaborations that may give rise to potential conflicts between interests can also greatly facilitate appropriate, scientifically robust, and timely vaccine development, implementation, and evaluation. At present, policies regarding the management of potential conflicts between interests are not ideal. To optimally manage interests in vaccine research, we recommend acknowledging all forms of interests and treating them all as relevant, developing appropriate collaborations, referring to all “conflicts of interest” simply as “interests” or “declarations,” and promoting transparency through developing consistent reporting mechanisms.

Abstract Background Almost 1% of Canadians are hepatitis C (HCV)-infected. The liver-specific complications of HCV are established but the extra-hepatic comorbidity, multimorbidity, and its relationship with HCV treatment, is less well known. We describe the morbidity burden for people with HCV and the relationship between multimorbidity and HCV treatment uptake and cure in the pre- and post-direct acting antiviral (DAA) era. Methods We linked adults with HCV at The Ottawa Hospital Viral Hepatitis Program as of April 1, 2017 to provincial health administrative data and matched on age and sex to 5 Ottawa-area residents for comparison. We used validated algorithms to identify the prevalence of mental and physical health comorbidities, as well as multimorbidity (2+ comorbidities). We calculated direct age- and sex-standardized rates of comorbidity and comparisons were made by interferon-based and interferon-free, DAA HCV treatments. Results The mean age of the study population was 54.5 years (SD 11.4), 65% were male. Among those with HCV, 4% were HIV co-infected, 26% had liver cirrhosis, 47% received DAA treatment, and 57% were cured of HCV. After accounting for age and sex differences, the HCV group had greater multimorbidity (prevalence ratio (PR) 1.38, 95% confidence interval (CI) 1.20 to 1.58) and physical-mental health multimorbidity (PR 2.71, 95% CI 2.29–3.20) compared to the general population. Specifically, prevalence ratios for people with HCV were significantly higher for diabetes, renal failure, cancer, asthma, chronic obstructive pulmonary disease, substance use disorder, mood and anxiety disorders and liver failure. HCV treatment and cure were not associated with multimorbidity, but treatment prevalence was significantly lower among middle-aged individuals with substance use disorders despite no differences in prevalence of cure among those treated. Conclusion People with HCV have a higher prevalence of comorbidity and multimorbidity compared to the general population. While HCV treatment was not associated with multimorbidity, people with substance use disorder were less likely to be treated. Our results point to the need for integrated, comprehensive models of care delivery for people with HCV.

Introduction The Applied Health Research Question (AHRQ) portfolio is an initiative funded by the Ontario Ministry of Health. Knowledge users submit AHRQ requests to use administrative health data to inform their planning, policy and program development. Objectives and Approach A request to estimate prevalence and incidence of blood-borne viral infections (BBVI) among individuals seeking fertility treatment services was approved by the ICES AHRQ team. To determine whether current BBVI testing guidelines are effective for timely identification of BBVI among individuals undergoing fertility treatment, this AHRQ sought to estimate: a) the testing prevalence for BBVI (using viral hepatitis as a proxy for all BBVI including HIV), and b) BBVI incidence over a five-year follow-up period. We used infertility codes billed by gynecologists and urologists to identify individuals seeking fertility treatment between April 1, 2002 and March 31, 2013. We looked forward five years from a first BBVI test billed by a physician and assessed annual and cumulative testing prevalence and incidence of viral hepatitis and HIV using rule-based administrative algorithms. Results In total, 184,328 individuals (61.6% female) were included. The five-year BBVI testing prevalence was 45.5% and the median number of tests was 2 (interquartile range: 2-3). An estimated 949 new cases (48% diagnosed within 12 months of first BBVI test) of viral hepatitis were identified in the five-year follow-up with a cumulative incidence of 522 (95%CI 489-556) per 100,000 population. There were 57 new HIV cases (68% diagnosed within 12 months of first BBVI test) with a cumulative incidence of 31.4 (95%CI 23.7-40.6) per 100,000. The median times from first BBVI test to hepatitis and HIV diagnoses were 13.0 months (IQR 2.33-32.2) and 3.0 months (IQR 1.34-20.0), respectively. Conclusion / Implications These findings can be used to develop evidence-based BBVI testing guidelines for individuals seeking fertility treatment services.

Accurate and complete immunization data are necessary to assess vaccine coverage, safety and effectiveness. Across Canada, different methods and data sources are used to assess vaccine coverage, but these have not been systematically described. Our primary objective was to examine and describe the methods used to determine immunization coverage in Canada. The secondary objective was to compare routine infant and childhood coverage estimates derived from the Canadian 2013 Childhood National Immunization Coverage Survey (cNICS) with estimates collected from provinces and territories (P/Ts). We collected information from key informants regarding their provincial, territorial or federal methods for assessing immunization coverage. We also collected P/T coverage estimates for select antigens and birth cohorts to determine absolute differences between these and estimates from cNICS. Twenty-six individuals across 16 public health organizations participated between April and August 2015. Coverage surveys are conducted regularly for toddlers in Quebec and in one health authority in British Columbia. Across P/Ts, different methodologies for measuring coverage are used (e.g., valid doses, grace periods). Most P/Ts, except Ontario, measure up-to-date (UTD) coverage and 4 P/Ts also assess on-time coverage. The degree of concordance between P/T and cNICS coverage estimates varied by jurisdiction, antigen and age group. In addition to differences in the data sources and processes used for coverage assessment, there are also differences between Canadian P/Ts in the methods used for calculating immunization coverage. Comparisons between P/T and cNICS estimates leave remaining questions about the proportion of children fully vaccinated in Canada.

Introduction During the 2009 H1N1 pandemic, less than half of pregnant women in Ontario received the recommended influenza vaccine. Commonly-cited reasons for low vaccine uptake include misconceptions about the possible impact of maternal influenza infection and vaccine safety. Providing data on previously understudied pediatric health outcomes may help increase vaccine uptake. Objectives and Approach We conducted a retrospective cohort study of all live births from November 2nd, 2009 to October 31st, 2010 using the BORN Ontario province-wide birth registry containing information on H1N1 vaccination. These data were deterministically/probabilistically linked with several health administrative databases held at the Institute for Clinical Evaluative Sciences to ascertain specific immune-related pediatric health outcomes and health services utilization over 5 years of follow-up. Negative binomial regression models were used to evaluate the association between prenatal H1N1 vaccination and outcomes. Stabilized inverse probability of treatment weights (sIPTW) derived from the propensity scores were used to adjust for potential confounding. Results The study cohort included 104,310 eligible infants, 31,310 (30%) of whom were born to H1N1-vaccinated women. Median follow-up time was 5 years. Using sIPTWs we were able to achieve good balance of baseline measured covariates across exposure groups, with no absolute standardized differences larger than 7%. The sIPTW-adjusted analyses indicated no significant associations between prenatal exposure to H1N1 vaccination and upper respiratory infections (adjusted rate ratio [aRR] 1.01; 95% confidence interval [CI] 0.98-1.03), lower respiratory infections (aRR 1.00; 95%CI 0.96-1.04), otitis media (aRR 1.04; 95%CI 1.00-1.07), all infections (aRR 1.00; 95%CI 0.98-1.03), and rates of urgent and in-patient health services utilization (aRR 1.00; 95%CI 0.98-1.02). Conclusion/Implications Our primary findings suggest there are no associations between prenatal exposure to H1N1 vaccination and (1) the development of several immune-related health outcomes in children; (2) rates of health services utilization. Furthermore, our study provides new evidence on the long-term safety of influenza vaccination during pregnancy, which is currently lacking.

Introduction Annual evaluation of influenza vaccine effectiveness (VE) is required because of frequent changes to circulating and vaccine strains. Traditionally, VE studies enroll patients who fulfill case definitions for respiratory infections and are tested for influenza. VE estimates generated from convenience samples of routinely collected specimens might be biased. Objectives and Approach We assessed the validity of using data from respiratory specimens collected during clinical encounters to estimate VE. We created the Flu and Other Respiratory Viruses Research (FOREVER) Cohort by linking respiratory virus laboratory test results from 2009-2014 from 11 public health and 8 hospital laboratories across Ontario to health administrative databases, including databases with billing claims for physician- and pharmacist-administered influenza vaccines. We evaluated the presence of information and selection biases when using these data and estimated VE in community-dwelling older adults (>65) using the test-negative design under conditions that emulated the inclusion criteria in traditional VE studies. Results The FOREVER Cohort included test results from 283,711 respiratory specimens obtained from 216,730 individuals. The overall linkage proportion to health administrative databases using deterministic and probabilistic linkage methods was 97.5%. Influenza positivity for older adults with unknown lag between illness onset and specimen collection was similar to those for whom illness onset date was documented to be ≤7 days before specimen collection, suggesting minimal outcome misclassification associated with information bias. The likelihood of influenza testing was similar between vaccinated and unvaccinated individuals, suggesting an absence of selection bias that could arise when a case definition for influenza testing is not employed. Lastly, VE estimates were similar under various conditions, demonstrating the robustness of using these data, and were comparable to published estimates. Conclusion/Implications The FOREVER Cohort can be used to estimate VE with negligible bias. Compared to traditional VE studies that are limited to recruited patients, routinely collected specimens create a larger, more generalizable sample. Linkage to health administrative databases can identify those with comorbidities and permit evaluation of VE in high-risk groups.