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Routinely collected health data (RCD) including electronic health records, disease registries, health administrative data and wearables data are not specifically collected for research purposes. Analysis of these data poses unique methodological challenges that must be addressed when conducting research, particularly as availability and use increase. This scoping review aimed to identify methodological challenges in research using RCD from existing literature (registered protocol: https://doi.org/10.17605/OSF.IO/EBM4D). We searched 6 electronic databases, including medical, health economics, nursing and psychology research databases, between Jan 2015 and Jan 2023, combining multiple “RCD” and “research” search terms (e.g., epidemiologic, informatics, pharmaceutical research). After screening abstracts and full-texts, we doubly extracted methodological themes, categorizing them into different study stages. We screened more than 23,000 records and included 430 papers. Bias and confounding were the most common methodological issues identified, discussed in relation to both study design and data analysis. Data quality, including data accuracy, validation, completeness, timeliness and cleaning, also posed substantial challenges, particularly during data processing stage. Record linkage and conducting analyses using distributed health networks also pose unique methodological challenges. Heterogeneity, incorporating social determinants of health and statistical models that address methodological challenges are also described in the literature. External validity and reporting are important considerations for RCD research. Our review identified several methodological challenges facing researchers using RCD. These issues should be addressed to ensure methodologically sound research. These findings will inform the development of a standardized protocol template and accompanying educational platform aimed at enhancing methodological quality and transparency when conducting research using RCD.

Abstract Background and aims There is an incomplete understanding of the full safety profiles of repeated COVID-19 vaccinations in patients with inflammatory bowel disease (IBD). Among individuals with IBD, we assessed whether COVID-19 vaccines were associated with serious adverse events of special interest (AESI) and health care utilization [all-cause hospitalizations, Emergency Department (ED) visits, gastroenterology visits, IBD-related visits]. Methods Using comprehensive administrative health data from Ontario, Canada, adults with IBD who received at least one COVID-19 vaccine from December 2020-January 2022 were included. Self-controlled case series analyses were conducted to evaluate the relative incidence rates of AESI and health care utilization outcomes across post-vaccination risk and control periods. Results Among 88,407 IBD patients, 99.7% received mRNA vaccines and 75.9% received ≥ 3 doses. Relative to control periods, we did not detect an increase in AESI. IBD patients had fewer all-cause hospitalizations during post-vaccination risk periods. Patients experienced more all-cause ED visits after dose 2 [Relative Incidence (RI):1.08(95%CI:1.04–1.12)] but fewer visits after doses 3 [RI:0.85 (95%CI:0.81–0.90)] and 4 [RI:0.73 (95%CI:0.57–0.92)]. There was no increase in gastroenterologist visits or IBD-related health care utilization post-vaccination. There were fewer IBD-related hospitalizations after dose 1 [RI:0.84 (95%CI:0.72–0.98)] and 3 [RI:0.63 (95%CI:0.52–0.76)], fewer IBD-related ED visits after dose 3 [RI:0.81 (95%CI:0.71–0.91)] and 4 [RI:0.55 (95%CI:0.32–0.96)], and fewer outpatient visits after dose 2 [RI:0.91 (95%CI:0.90–0.93)] and 3 [RI:0.87 (95%CI:0.86–0.89)]. Conclusion This population-based study did not detect increased AESI, all-cause or IBD-related health care utilization following COVID-19 vaccination, suggesting a lack of association between vaccination and increased disease activity.

Background and Aims: Children with very early onset inflammatory bowel disease (VEO-IBD) are uniquely at risk of inadequate infliximab (IFX) exposure. We studied the association between standard body weight (BW)-based and body surface area (BSA)-based dosing strategies and outcomes. Methods: We identified VEO-IBD patients treated with IFX before 9 years at a single center. Patients were separated into those that received a BSA-based dose (200 mg/m2) and standard BW dosing (5 mg/kg). IFX drug levels, dose intensification, time on steroids, and long-term outcomes were compared. Receiver operator characteristic curves determined the optimal BW- and BSA-based dose to achieve a trough ≥10 μg/ml at dose 4 (IFX#4). Results: Forty-three children with VEO-IBD were identified. Receiver operator characteristic curves demonstrated optimal BW- and BSA-based doses to achieve IFX trough ≥10 μg/ml at IFX#4 were 7.5 mg/kg and 180mg/m2. Children were classified to standard BW dosing (22/43) and BSA dosing (10/43). IFX#4 trough was significantly higher in those who received BSA dosing (BSA 18.6 μg/ml [interquartile range 10.8–28.1] vs BW 5.1 μg/ml [interquartile range 2.6–10.7], P = .04). BSA dosing was more likely to achieve a target drug level >10 μg/ml at IFX#4 (BSA 70% vs BW 18%, P = .02). BW dosing was associated with a greater likelihood of dose escalation (BW 82% vs BSA 30%, P < .01) and a shorter time to first escalation. BSA dosing was associated with shorter time spent on steroids (P = .02). Conclusion: Young children require higher IFX dosing to achieve adequate drug exposure. Our data support the use of a BSA-based dose of 200 mg/m2 or, if a BW-based approach is used, 7.5 mg/kg. BSA dosing allows the use of a consistent dose over the age and weight spectrum.

Abstract Background Transition in care is defined as the “purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers.” Currently, there are no Level 1 evidence-based interventions to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the clinical and implementation effectiveness of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0–17.5 years. The intervention program consists of 4 core components: (1) individualized assessment, (2) transition navigator, (3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and (4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness and success, anxiety and depression scales, and health service utilization rates. Additionally, we will measure implementation outcomes and related barriers and facilitators for the intervention program. Discussion The type 1 hybrid effectiveness-implementation design will allow for the development of a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will allow centralization of interventions and funding in order to minimize the impact on local clinical practice or hospital resources. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach. Trial registration NCT05221281. Registry: ClinicalTrials.gov. Date of registration: February 2, 2022. https://clinicaltrials.gov/ct2/show/NCT05221281 .

Abstract Background Life expectancy in people with inflammatory bowel disease (IBD) has increased but remains shorter than in people without IBD. We describe the life expectancy associated with IBD therapies among the growing number of older adults living with IBD. Methods Older adults (≥ 65 years) with IBD were identified from population-based health administrative data using a validated algorithm. Life expectancy on patients’ 65th birthday, stratified by sex, was calculated using a period life table approach from age- and sex-specific mortality rates among patients receiving immunomodulator monotherapy, biologic monotherapy, combination therapy, mesalamine, systemic steroids, and no therapy. Results Among 28,260 older adults with IBD (239,125 person-years of follow-up), life expectancy at 65 years was longest for patients taking mesalamine (females: 22.1 years, 95% CI 21.8–22.5; males: 19.6 years, 95% CI 19.3–20.0) and shortest for patients taking steroids (females: 11.7 years, 95% CI 11.0–12.4; males 10.3 years, 95% CI 9.7–10.8). Life expectancy was similar for patients receiving immunomodulator monotherapy and biologic monotherapy. Immunomodulator monotherapy was associated with a reduction in life expectancy compared to combination therapy by 5.1 (95% CI 2.3–7.8) in females and 2.8 years (95% CI 0.1–5.5) in males. Conclusions Life expectancy varies across therapies used for IBD, with differences likely arising from a combination of medication effectiveness, safety profiles, disease severity, and comorbid conditions. These considerations should be balanced when deciding on a therapeutic approach for the management of IBD in older adults.

Background and Aims: Diagnosis of monogenic disease is increasingly important for patient care and personalizing therapy. However, the current process is nonstandardized, expensive, and time consuming. There is currently no accepted strategy to help identify disease-causing variants in monogenic inflammatory bowel disease (IBD). The aim of the study is to develop a prioritization strategy for monogenic IBD variant discovery through detailed analysis of a whole-exome sequencing (WES) data set. Methods: All consenting pediatric patients with IBD presenting to our tertiary care hospital during the study period were enrolled and underwent WES (n = 1005). Available family members also underwent WES. Variants were analyzed en masse using the GEMINI framework and were further annotated using data from dbNSFP, Combined Annotation Dependent Depletion, and gnomAD. Known disease-causing variants (n = 36) were used as positive controls. Machine learning algorithms were optimized and then compared to assist with identifying monogenic IBD case characteristics. Results: Initial gene-level analysis identified 11 genes not previously linked to IBD that could potentially harbor IBD-causing variants. Machine learning algorithms identified 4 primary variant characteristics (Combined Annotation Dependent Depletion score, dbNSFP score, relationship with a known immunodeficiency gene, and alternate allele frequency), and optimal threshold values for each were determined to assist with identifying monogenic IBD variants. Based on these characteristics, an automated variant prioritization pipeline was then created that filters and prioritizes variants from >100,000 variants per patient down to a mean of 15. This pipeline is available online for all to use. Conclusion: Leveraging a large WES data set, we demonstrate a statistically rigorous strategy for prioritization of variants for monogenic IBD diagnosis.

Abstract Background Advanced colorectal neoplasms (ACNs), including colorectal cancers (CRC) and high-risk adenomas (HRA), are detected in less than 20% of persons aged 50 years or older who undergo colonoscopy. We sought to derive personalized predictive models of risk of harbouring ACNs to improve colonoscopy wait times for high-risk patients and allocation of colonoscopy resources. Methods We characterized colonoscopy indications, neoplasia risk factors and colonoscopy findings through chart review for consecutive individuals aged 50 years or older who underwent outpatient colonoscopy at The Ottawa Hospital (Ottawa, Canada) between April 1, 2008 and March 31, 2012 for non-life threatening indications. We linked patients to population-level health administrative datasets to ascertain additional historical predictor variables and derive multivariable logistic regression models for risk of harboring ACNs at colonoscopy. We assessed model discriminatory capacity and calibration and the ability of the models to improve colonoscopy specificity while maintaining excellent sensitivity for ACN capture. Results We modelled 17 candidate predictors in 11,724 individuals who met eligibility criteria. The final CRC model comprised 8 variables and had a c-statistic value of 0.957 and a goodness-of-fit p-value of 0.527. Application of the models to our cohort permitted 100% sensitivity for identifying persons with CRC and > 90% sensitivity for identifying persons with HRA, while improving colonoscopy specificity for ACNs by 23.8%. Conclusions Our multivariable models show excellent discriminatory capacity for persons with ACNs and could significantly increase colonoscopy specificity without overly sacrificing sensitivity. If validated, these models could allow more efficient allocation of colonoscopy resources, potentially reducing wait times for those at higher risk while deferring unnecessary colonoscopies in low-risk individuals.

Abstract Background Respiratory syncytial virus (RSV) infection is a major cause of hospitalization in young children in Canada, despite routine immunoprophylaxis in those with medical risk factors. We aimed to determine if cold temperatures are associated with RSV hospitalization. Methods We conducted a population-based nested case–control study of children in Ontario, Canada, using health administrative data. We compared children hospitalized for RSV between September 1, 2011 and August 31, 2012 to age and sex matched controls. We used multivariable logistic regression to identify associations between minimum daily temperature and RSV hospitalizations with adjustment for sociodemographic and environmental factors. Results We identified 1670 children with RSV hospitalizations during the study period and 6680 matched controls. Warmer temperatures (OR = 0.94, 95%CI: 0.93, 0.95) were associated with lower odds of RSV hospitalization. Southern ecozone (OR = 1.6, 95%CI: 1.2, 2.1), increased ozone concentration (OR = 1.03, 95%CI: 1.01, 1.06) and living in a lower income neighbourhood (OR = 1.3, 95%CI: 1.1, 1.5) significantly increased the odds of RSV hospitalization, as did living in a household with a larger number of siblings in a sub-cohort of children (OR = 1.34, 95%CI: 1.26, 1.41). Conclusions In Ontario, the likelihood of having an RSV hospitalization is associated with colder temperature exposures and socioeconomic factors.

Abstract Background Health administrative data is increasingly used to conduct population-based health services research. A major limitation of these data for the study of inflammatory bowel diseases is the absence of detailed clinical information relating to disease burden. We used Ontario health administrative data to develop predictive models of disease burden at diagnosis in ulcerative colitis (UC) patients for future use in population-based studies of incident UC cohorts. Methods Through chart review, we characterized macroscopic colitis activity and extent at diagnosis in consecutive adult-onset UC patients diagnosed at The Ottawa Hospital between 2001 and 2012. We linked this cohort to Ontario health administrative data to test the capacity of administrative variables to discriminate different levels of disease activity, disease extent and the disease burden (a composite of disease extent and activity). We modelled outcomes as binary (using logistic regression) and ordinal (using proportional odds regression) variables and performed bootstrap validation of our final models. Results We tested 20 administrative variables in 587 eligible patients. The logistic model of total disease burden (severe and extensive colitis vs. all other phenotypes) showed moderate discriminatory capacity (optimism-corrected c-statistic value 0.729). Individual models of disease extent and disease activity showed poorer discriminatory capacity (c-statistic value

South Asian (SA) Canadian immigrants have a higher risk of developing certain immune-mediated inflammatory diseases compared to non-migrant SAs. We sought to investigate the effect of migration on the gut metagenome and to identify microbiological associations between migration and conditions that may influence the development of immune-mediated inflammatory diseases. Metagenomic analysis of 58 first-generation (GEN1) SA immigrants and 38 unrelated Canadian born children-of-immigrants (GEN2) determined that the time lived in Canada was associated with continued changes in gut microbial communities. Migration of GEN1 to Canada early in life results in a gut community with similarities to GEN2 SA Canadians and non-SA North Americans. Conversely, GEN1 immigrants who arrived recently to Canada exhibited pronounced differences from GEN2, while displaying microbial similarities to a non-migrating SA cohort. Multivariate analysis identified that community composition was primarily influenced by high abundance taxa. Prevotella copri dominated in GEN1 and non-migrant SAs. Clostridia and functionally related Bacteroidia spp. replaced P. copri dominance over generations in Canada. Mutually exclusive Dialister species occurred at differing relative abundances over time and generations in Canada. This shift in species composition is accompanied by a change in genes associated with carbohydrate utilization and short-chain fatty acid production. Total energy derived from carbohydrates compared to protein consumption was significantly higher for GEN1 recent immigrants, which may influence the functional requirements of the gut community. This study demonstrates the associations between migration and the gut microbiome, which may be further associated with the altered risk of immune-mediated inflammatory diseases observed for SA Canadians.

Background: High-income nations have the highest rates of inflammatory bowel disease (IBD). The incidence of pediatric-onset IBD is increasing faster than IBD diagnosed in older individuals. Previous epidemiological studies have shown that air pollution might be a risk factor for development of earlier-onset IBD, but results remain mixed. Objectives: The objective of this study was to evaluate the associations between maternal and early-life exposures to nitrogen dioxide (NO2), fine particulate matter (PM2.5), ozone (O3,) and oxidant capacity (Ox) and risk of pediatric-onset IBD diagnosis. Methods: We conducted a retrospective cohort study using linked population-based health administrative data. Singleton livebirths in Ontario, Canada between April 1st, 1991 and March 31st, 2014 were included. We investigated the association between weekly exposures during pregnancy and annual exposures from birth until the age of 18 years, and IBD diagnosed

Background: Intussusception has been identified as a rare adverse event following rotavirus immunization. We sought to determine the incidence of intussusception among infants in Canada both before and after introduction of rotavirus immunization programs. Methods: We used Canadian Institute for Health Information (CIHI) Discharge Abstract Database (DAD) to identify infants under 1 y of age who were admitted to a Canadian hospital, which the exception of Quebec, which does not submit data to CIHI, with a diagnosis of intussusception (ICD-10 code K56.1, and ICD-9 code 560) between January 1st, 2003 and December 31, 2013. We compared rates of intussusception hospitalization before and after rotavirus vaccine program introduction. Rates were adjusted for calendar year, age (in months), sex and region using Poisson regression models. Denominator data for infants under 1 year, stratified by age in months, were obtained from Statistics Canada. Results: Annual intussusception hospitalization rates ranged from 20-30 per 100,000 infants over the study period, with no evidence of a trend over time. Intussusception hospitalization rates were highest in infants 4 to

Crohn’s disease is associated with altered intestinal microbiota. Here, the authors show that the microbe Atopobium parvulumis associated with Crohn’s disease patients, triggers colitis in a mouse model, and that scavenging microbe-induced hydrogen sulfide improved symptoms in mice.

Abstract Background The self-controlled case series (SCCS) is a useful design for investigating associations between outcomes and transient exposures. The SCCS design controls for all fixed covariates, but effect modification can still occur. This can be evaluated by including interaction terms in the model which, when exponentiated, can be interpreted as a relative incidence ratio (RIR): the change in relative incidence (RI) for a unit change in an effect modifier. Methods We conducted a scoping review to investigate the use of RIRs in published primary SCCS studies, and conducted a case-study in one of our own primary SCCS studies to illustrate the use of RIRs within an SCCS analysis to investigate subgroup effects in the context of comparing whole cell (wcp) and acellular (acp) pertussis vaccines. Using this case study, we also illustrated the potential utility of RIRs in addressing the healthy vaccinee effect (HVE) in vaccine safety surveillance studies. Results Our scoping review identified 122 primary studies reporting an SCCS analysis. Of these, 24 described the use of interaction terms to test for effect modification. 21 of 24 studies reported stratum specific RIs, 22 of 24 reported the p-value for interaction, and less than half (10 of 24) reported the estimate of the interaction term/RIR, the stratum specific RIs and interaction p-values. Our case-study demonstrated that there was a nearly two-fold greater RI of ER visits and admissions following wcp vaccination relative to acp vaccination (RIR = 1.82, 95 % CI 1.64–2.01), where RI estimates in each subgroup were clearly impacted by a strong healthy vaccinee effect. Conclusions We demonstrated in our scoping review that calculating RIRs is not a widely utilized strategy. We showed that calculating RIRs across time periods is useful for the detection of relative changes in adverse event rates that might otherwise be missed due to the HVE. Many published studies of vaccine-associated adverse events could have missed/underestimated important safety signals masked by the HVE. With further development, our application of RIRs could be an important tool to address the HVE, particularly in the context of self-controlled study designs.

Objectives. The current number of healthcare providers (HCP) caring for children with inflammatory bowel disease (IBD) across Canadian tertiary-care centres is underinvestigated. The aim of this survey was to assess the number of healthcare providers (HCP) in ambulatory pediatric IBD care across Canadian tertiary-care centres. Methods. Using a self-administered questionnaire, we examined available resources in academic pediatric centres within the Canadian Children IBD Network. The survey evaluated the number of HCP providing ambulatory care for children with IBD. Results. All 12 tertiary pediatric gastroenterology centres participating in the network responded. Median full-time equivalent (FTE) of allied health professionals providing IBD care at each site was 1.0 (interquartile range (IQR) 0.6–1.0) nurse, 0.5 (IQR 0.2–0.8) dietitian, 0.3 (IQR 0.2–0.8) social worker, and 0.1 (IQR 0.02–0.3) clinical psychologists. The ratio of IBD patients to IBD physicians was 114 : 1 (range 31 : 1–537 : 1), patients to nurses/physician assistants 324 : 1 (range 150 : 1–900 : 1), dieticians 670 : 1 (range 250 : 1–4500 : 1), social workers 1558 : 1 (range 250 : 1–16000 : 1), and clinical psychologists 2910 : 1 (range 626 : 1–3200 : 1). Conclusions. There was a wide variation in HCP support among Canadian centres. Future work will examine variation in care including patients’ outcomes and satisfaction across Canadian centres.

Canada has one of the highest rates of inflammatory bowel disease (IBD) and the disease represents a significant health, social, and economic burden. There is currently no cure for IBD, although earlier diagnosis and new therapies have improved the overall health outcomes and quality of life for patients. Crohn’s and Colitis Canada is Canada’s only national, volunteer-based charity dedicated to finding cures for IBD and improving the lives of those affected, through research, education, patient programs, advocacy, and increased awareness. On April 30, 2015, Crohn’s and Colitis Canada hosted the “Patient and Healthcare Professional Summit on the Burden of Disease in IBD” to obtain a deeper understanding of the unmet needs of IBD patients and their caregivers. Through personal vignettes, patients articulated a pressing need to increase understanding of the challenges faced by people suffering from IBD among both health care professionals and the general public, develop best practices for navigating life transitions and addressing the unique challenges faced by children with IBD, and provide equitable access to appropriate, effective, and affordable treatments. The recommendations that emerged from the summit will inform about efforts to increase public awareness, inform about advocacy strategies, and contribute to the development of research priorities.

Objective Health administrative data can support population-level research among people who inject drugs (PWID), however these data sources remain underutilized due to the difficulty in identifying drug use in routinely collected data. We validated case-ascertainment algorithms to identify PWID and tested their application in a hepatitis C (HCV) cohort in Ontario, Canada. Approach We conducted a validation study using reference standard cohorts of PWID recruited via community-based studies and population controls linked to health administrative data in Ontario, Canada (1992-2020). Tested case-ascertainment algorithms included combinations of hospitalizations/emergency department (ED) visits for drug use/poisoning, physician visits for drug use, opioid agonist treatment (OAT), or injecting-related infections. Sensitivity and specificity were estimated for lifetime history and recent injecting (past 1-5 years). We applied a high-performing algorithm among all Ontarians with laboratory-confirmed HCV between 1999-2018, to identify a sub-cohort of PWID with HCV. Results An algorithm including ≥1 hospitalization/ED visit or ≥1 physician visit for drug use or ≥1 OAT record had high accuracy for identifying IDU history (91.6% sensitivity, 94.2% specificity) and recent IDU (using 3 years lookback: 80.4% sensitivity, 99% specificity). When applied to a provincial cohort of 112,947 Ontarians diagnosed with HCV, this algorithm estimated 46% (N=52,248) had a history of IDU, of whom 52% (N=27,246) had an indication of recent IDU (within the past 3 years). Conclusion The methods developed in this study can enhance the capacity of population-level health research among people who inject drugs and support applied public health interventions towards hepatitis C elimination.

Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.Methods The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.Results 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.Conclusion Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.

Abstract Background Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data. Methods The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline. Discussion Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

IMPORTANCE:Celiac disease (CD) is a common pediatric illness, and awareness of gluten-related disorders including CD is growing. Health administrative data represents a unique opportunity to conduct population-based surveillance of this chronic condition and assess the impact of caring for children with CD on the health system. OBJECTIVE:The objective of the study was to validate an algorithm based on health administrative data diagnostic codes to accurately identify children with biopsy-proven CD. We also evaluated trends over time in the use of health services related to CD by children in Ontario, Canada. STUDY DESIGN AND SETTING:We conducted a retrospective cohort study and validation study of population-based health administrative data in Ontario, Canada. All cases of biopsy-proven CD diagnosed 2005-2011 in Ottawa were identified through chart review from a large pediatric health care center, and linked to the Ontario health administrative data to serve as positive reference standard. All other children living within Ottawa served as the negative reference standard. Case-identifying algorithms based on outpatient physician visits with associated ICD-9 code for CD plus endoscopy billing code were constructed and tested. Sensitivity, specificity, PPV and NPV were tested for each algorithm (with 95% CI). Poisson regression, adjusting for sex and age at diagnosis, was used to explore the trend in outpatient visits associated with a CD diagnostic code from 1995-2011. RESULTS:The best algorithm to identify CD consisted of an endoscopy billing claim follow by 1 or more adult or pediatric gastroenterologist encounters after the endoscopic procedure. The sensitivity, specificity, PPV, and NPV for the algorithm were: 70.4% (95% CI 61.1-78.4%), >99.9% (95% CI >99.9->99.9%), 53.3% (95% CI 45.1-61.4%) and >99.9% (95% CI >99.9->99.9%) respectively. It identified 1289 suspected CD cases from Ontario-wide administrative data. There was a 9% annual increase in the use of this combination of CD-associated diagnostic codes in physician billing data (RR 1.09, 95% CI 1.07-1.10, P

RSV is a common illness among young children that causes significant morbidity and health care costs.Routinely collected health administrative data can be used to track disease incidence, explore risk factors and conduct health services research. Due to potential for misclassification bias, the accuracy of data-elements should be validated prior to use. The objectives of this study were to validate an algorithm to accurately identify pediatric cases of hospitalized respiratory syncytial virus (RSV) from within Ontario's health administrative data, estimate annual incidence of hospitalization due to RSV and report the prevalence of major risk factors within hospitalized patients.A retrospective chart review was performed to establish a reference-standard cohort of children from the Ottawa region admitted to the Children's Hospital of Eastern Ontario (CHEO) for RSV-related disease in 2010 and 2011. Chart review data was linked to Ontario's administrative data and used to evaluate the diagnostic accuracy of algorithms of RSV-related ICD-10 codes within provincial hospitalization and emergency department databases. Age- and sex-standardized incidence was calculated over time, with trends in incidence assessed using Poisson regression.From a total of 1411 admissions, chart review identified 327 children hospitalized for laboratory confirmed RSV-related disease. Following linkage to administrative data and restriction to first admissions, there were 289 RSV patients in the reference-standard cohort. The best algorithm, based on hospitalization data, resulted in sensitivity 97.9% (95%CI: 95.5-99.2%), specificity 99.6% (95%CI: 98.2-99.8%), PPV 96.9% (95%CI: 94.2-98.6%), NPV 99.4% (95%CI: 99.4-99.9%). Incidence of hospitalized RSV in Ontario from 2005-2012 was 10.2 per 1000 children under 1 year and 4.8 per 1000 children aged 1 to 3 years. During the surveillance period, there was no identifiable increasing or decreasing linear trend in the incidence of hospitalized RSV, hospital length of stay and PICU admission rates. Among the Ontario RSV cohort, 16.3% had one or more major risk factors, with a decreasing trend observed over time.Children hospitalized for RSV-related disease can be accurately identified within population-based health administrative data. RSV is a major public health concern and incidence has not changed over time, suggesting a lack of progress in prevention.

BACKGROUND: Inflammatory bowel diseases (IBD) – Crohn’s disease (CD) and ulcerative colitis (UC) – significantly impact quality of life and account for substantial costs to the health care system and society.

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

There is a high and rising rate of immune-mediated diseases in the Western world. Immigrants from South Asia have been reported to be at higher risk upon arrival to the West. We determined the risk of immune-mediated diseases in South Asian and other immigrants to Ontario, Canada, and their Ontario-born children.Population-based cohorts of patients with asthma, type 1 diabetes (T1DM), type 2 diabetes (T2DM), and inflammatory bowel disease (IBD) were derived from health administrative data. We determined the standardized incidence, and the adjusted risk of these diseases in immigrants from South Asia, immigrants from other regions, compared with non-immigrant residents of Ontario. The risk of these diseases in the Ontario-born children of immigrants were compared to the children of non-immigrants.Compared to non-immigrants, adults from South Asia had higher risk of asthma (IRR 1.56, 95%CI 1.51-1.61) and T2DM (IRR 2.59, 95%CI 2.53-2.65). Adults from South Asia had lower incidence of IBD than non-immigrants (IRR 0.32, 95%CI 0.22-0.49), as did immigrants from other regions (IRR 0.29, 95%CI 0.20-0.42). Compared to non-immigrant children, the incidence of asthma (IRR 0.66, 95%CI 0.62-0.71) and IBD (IRR 0.47, 95%CI 0.33-0.67) was low amongst immigrant children from South Asia. However, the risk in Ontario-born children of South Asian immigrants relative to the children of non-immigrants was higher for asthma (IRR 1.75, 95%CI 1.69-1.81) and less attenuated for IBD (IRR 0.90, 95%CI 0.65-1.22).Early-life environmental exposures may trigger a genetic predisposition to the development of asthma and IBD in South Asian immigrants and their Canada-born children.

OBJECTIVE:Routinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. METHODS:Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period. RESULTS:The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist. CONCLUSIONS:The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.

In recent years, pediatric health care has embraced the concept of quality improvement to improve patient outcomes. As quality improvement efforts are implemented, network collaboration (where multiple centers and practices implement standardized programs) is a popular option. In a collaborative network, improvement in the conduct of structural, process and outcome quality measures can lead to improvements in overall health, and benchmarks can be used to assess and compare progress. In this review article, we provided an overview of the quality improvement movement and the role of quality indicators in this movement. We reviewed current quality improvement efforts in pediatric inflammatory bowel disease (IBD), as well as other pediatric chronic illnesses. We discussed the need to standardize the development of quality indicators used in quality improvement networks to assess medical care, and the validation techniques which can be used to ensure that process indicators result in improved outcomes of clinical significance. We aimed to assess current quality improvement efforts in pediatric IBD and other diseases, such as childhood asthma, childhood arthritis, and neonatal health. By doing so, we hope to learn from their successes and failures and to move the field forward for future improvements in the care provided to children with IBD.