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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.

Inflammatory bowel disease is a global disease in the 21st century. We aimed to assess the changing incidence and prevalence of inflammatory bowel disease around the world. We searched MEDLINE and Embase up to and including Dec 31, 2016, to identify observational, population-based studies reporting the incidence or prevalence of Crohn's disease or ulcerative colitis from 1990 or later. A study was regarded as population-based if it involved all residents within a specific area and the patients were representative of that area. To be included in the systematic review, ulcerative colitis and Crohn's disease needed to be reported separately. Studies that did not report original data and studies that reported only the incidence or prevalence of paediatric-onset inflammatory bowel disease (diagnosis at age <16 years) were excluded. We created choropleth maps for the incidence (119 studies) and prevalence (69 studies) of Crohn's disease and ulcerative colitis. We used temporal trend analyses to report changes as an annual percentage change (APC) with 95% CI. We identified 147 studies that were eligible for final inclusion in the systematic review, including 119 studies of incidence and 69 studies of prevalence. The highest reported prevalence values were in Europe (ulcerative colitis 505 per 100 000 in Norway; Crohn's disease 322 per 100 000 in Germany) and North America (ulcerative colitis 286 per 100 000 in the USA; Crohn's disease 319 per 100 000 in Canada). The prevalence of inflammatory bowel disease exceeded 0·3% in North America, Oceania, and many countries in Europe. Overall, 16 (72·7%) of 22 studies on Crohn's disease and 15 (83·3%) of 18 studies on ulcerative colitis reported stable or decreasing incidence of inflammatory bowel disease in North America and Europe. Since 1990, incidence has been rising in newly industrialised countries in Africa, Asia, and South America, including Brazil (APC for Crohn's disease +11·1% [95% CI 4·8–17·8] and APC for ulcerative colitis +14·9% [10·4–19·6]) and Taiwan (APC for Crohn's disease +4·0% [1·0–7·1] and APC for ulcerative colitis +4·8% [1·8–8·0]). At the turn of the 21st century, inflammatory bowel disease has become a global disease with accelerating incidence in newly industrialised countries whose societies have become more westernised. Although incidence is stabilising in western countries, burden remains high as prevalence surpasses 0·3%. These data highlight the need for research into prevention of inflammatory bowel disease and innovations in health-care systems to manage this complex and costly disease. None.

In pharmacoepidemiology, routinely collected data from electronic health records (including primary care databases, registries, and administrative healthcare claims) are a resource for research evaluating the real world effectiveness and safety of medicines. Currently available guidelines for the reporting of research using non-randomised, routinely collected data—specifically the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) and the Strengthening the Reporting of OBservational studies in Epidemiology (STROBE) statements—do not capture the complexity of pharmacoepidemiological research. We have therefore extended the RECORD statement to include reporting guidelines specific to pharmacoepidemiological research (RECORD-PE). This article includes the RECORD-PE checklist (also available on www.record-statement.org) and explains each checklist item with examples of good reporting. We anticipate that increasing use of the RECORD-PE guidelines by researchers and endorsement and adherence by journal editors will improve the standards of reporting of pharmacoepidemiological research undertaken using routinely collected data. This improved transparency will benefit the research community, patient care, and ultimately improve public health.

Intestinal microbial dysbiosis is associated with Crohn’s disease (CD). However, the mechanisms leading to the chronic mucosal inflammation that characterizes this disease remain unclear. In this report, we use systems-level approaches to study the interactions between the gut microbiota and host in new-onset paediatric patients to evaluate causality and mechanisms of disease. We report an altered host proteome in CD patients indicative of impaired mitochondrial functions. In particular, mitochondrial proteins implicated in H 2 S detoxification are downregulated, while the relative abundance of H 2 S microbial producers is increased. Network correlation analysis reveals that Atopobium parvulum controls the central hub of H 2 S producers. A. parvulum induces pancolitis in colitis-susceptible interleukin-10-deficient mice and this phenotype requires the presence of the intestinal microbiota. Administrating the H 2 S scavenger bismuth mitigates A. parvulum -induced colitis in vivo . This study reveals that host–microbiota interactions are disturbed in CD and thus provides mechanistic insights into CD pathogenesis. Crohn’s disease is associated with altered intestinal microbiota. Here, the authors show that the microbe Atopobium parvulum is associated with Crohn’s disease patients, triggers colitis in a mouse model, and that scavenging microbe-induced hydrogen sulfide improved symptoms in mice.

The incidence of pediatric-onset inflammatory bowel disease (IBD) is increasing worldwide. We used population-based health administrative data to determine national Canadian IBD incidence, prevalence, and trends over time of childhood-onset IBD. We identified children <16 years (y) diagnosed with IBD 1999-2010 from health administrative data in five provinces (Alberta, Manitoba, Nova Scotia, Ontario, Quebec), comprising 79.2% of the Canadian population. Standardized incidence and prevalence were calculated per 100,000 children. Annual percentage change (APC) in incidence and prevalence were determined using Poisson regression analysis. Provincial estimates were meta-analyzed using random-effects models to produce national estimates. 5,214 incident cases were diagnosed during the study period (3,462 Crohn's disease, 1,382 ulcerative colitis, 279 type unclassifiable). The incidence in Canada was 9.68 (95% CI 9.11 to 10.25) per 100,000 children. Incidence was similar amongst most provinces, but higher in Nova Scotia. APC in incidence did not significantly change over the study period in the overall cohort (+2.06%, 95% CI -0.64% to +4.76%). However, incidence significantly increased in children aged 0-5y (+7.19%, 95% +2.82% to +11.56%). Prevalence at the end of the study period in Canada was 38.25 (95% CI 35.78 to 40.73) per 100,000 children. Prevalence increased significantly over time, APC +4.56% (95% CI +3.71% to +5.42%). Canada has amongst the highest incidence of childhood-onset IBD in the world. Prevalence significantly increased over time. Incidence was not statistically changed with the exception of a rapid increase in incidence in the youngest group of children.

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. 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. 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. 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.

Inflammatory bowel disease (IBD) may be life-threatening and often reduces quality of life. We determined trends in life expectancy and health-adjusted life expectancy in people with and without IBD. We conducted a retrospective cohort study of population-level health administrative, demographic and health survey data available from databases in Ontario. We matched people with a diagnosis of IBD to those without a diagnosis of IBD. We used period life tables that were generated using age- and sex-specific 5-year mortality rates to calculate life expectancy (for 1996, 2000, 2008 and 2011). We incorporated the Health Utility Index (National Population Health Study; Canadian Community Health Survey) to estimate health-adjusted life expectancy (for 1996, 2000 and 2008). Life expectancy in patients with IBD increased between 1996 and 2011 (females: from 75.5 to 78.4 yr, difference: 2.9 yr [95% confidence interval (CI) 1.3 to 4.5]; males: from 72.2 to 75.5 yr, difference: 3.2 yr [95% CI 2.1 to 4.4]). Between 1996 and 2008, health-adjusted life expectancy decreased among males by 3.9 years (95% CI 1.2 to 6.6). There was no statistically significant change in health-adjusted life expectancy among females with IBD (difference: 2.0 yr, 95% CI −1.6 to 5.7). Life expectancy and health-adjusted life expectancy were lower in people with IBD compared with those without IBD. Differences in life expectancy in people with and without IBD ranged from 6.6 to 8.1 years in females and 5.0 to 6.1 years in males, depending on the year. Differences in health-adjusted life expectancy for people with and without IBD ranged from 9.5 to 13.5 years in females and 2.6 to 6.7 years in males. Whilst life expectancy has increased among people with IBD, a gap in life expectancy between those with and without IBD remains, and the effect of pain on daily functioning contributes substantially to reduced health-adjusted life expectancy, suggesting that improved pain mitigation strategies should be implemented.

Temporal trends in the incidence of pediatric-onset inflammatory bowel disease (IBD) are controversial and a wide range of estimates have been reported worldwide. We conducted a systematic review of research describing the epidemiology of childhood-onset IBD to assess changes in incidence rates over time and to evaluate international differences.MethodsThe following electronic databases were searched for articles published 1950–2009: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane IBD/Functional Bowel Disorders Group Specialised Trial Register. All included studies reported incidence or prevalence of IBD, Crohn's disease (CD) or ulcerative colitis (UC). Two authors independently completed the data extraction form for each eligible study. Choropleth maps demonstrated the international incidence of IBD, CD, and UC. Incidence of CD and UC was graphed using data from studies reporting rates in multiple time periods.ResultsThe search yielded 2209 references and review resulted in 139 included studies from 32 countries. A wide range of incidence was reported internationally; however, rates of IBD were not described in most countries. Twenty-eight studies (20.1%) used statistical analysis to assess trends over time, and 77.8% reported statistically significantly increased incidence of pediatric IBD. Of studies calculating statistical trends in CD incidence, 60% reported significantly increased incidence. Of similar UC studies, 20% reported significantly increased incidence.ConclusionsGlobally rising rates of pediatric IBD (due primarily to the rising incidence of CD) was demonstrated in both developed and developing nations; however, most countries lack accurate estimates. Analyzing incidence trends may help identify specific environmental and genetic risk factors for pediatric IBD. (Inflamm Bowel Dis 2011;)

Temporal changes for intestinal resections for Crohn's disease (CD) are controversial. We validated administrative database codes for CD diagnosis and surgery in hospitalized patients and then evaluated temporal trends in CD surgical resection rates. First, we validated International Classification of Disease (ICD)-10-CM coding for CD diagnosis in hospitalized patients and Canadian Classification of Health Intervention coding for surgical resections. Second, we used these validated codes to conduct population-based surveillance between fiscal years 2002 and 2010 to identify adult CD patients undergoing intestinal resection (n=981). Annual surgical rate was calculated by dividing incident surgeries by estimated CD prevalence. Time trend analysis was performed and annual percent change (APC) with 95% confidence intervals (CI) in surgical resection rates were calculated using a generalized linear model assuming a Poisson distribution. In the validation cohort, 101/104 (97.1%) patients undergoing surgery and 191/200 (95.5%) patients admitted without surgery were confirmed to have CD on chart review. Among the 116 administrative database codes for surgical resection, 97.4% were confirmed intestinal resections on chart review. From 2002 to 2010, the overall CD surgical resection rate was 3.8 resections per 100 person-years. During the study period, rate of surgery decreased by 3.5% per year (95% CI: -1.1%, -5.8%), driven by decreasing emergent operations (-10.1% per year (95% CI: -13.4%, -6.7%)) whereas elective surgeries increased by 3.7% per year (95% CI: 0.1%, 7.3%). Overall surgical resection rates in CD are decreasing, but a paradigm shift has occurred whereby elective operations are now more commonly performed than emergent surgeries.

ABSTRACTBackgroundMultimorbidity, the co-occurrence of 2 or more chronic conditions, is important in patients with inflammatory bowel disease (IBD) given its association with complex care plans, poor health outcomes, and excess mortality. Our objectives were to describe premature death (age < 75 yr) among people with IBD and to identify patterns between multimorbidity and premature death among decedents with IBD. MethodsUsing the administrative health data of people with IBD who died between 2010 and 2020 in Ontario, Canada, we conducted a population-based, retrospective cohort study. We described the proportion of premature deaths among people with IBD. We developed statistical and machine learning models to predict premature death from the presence of 17 chronic conditions and the patients’ age at diagnosis. We evaluated models using accuracy, positive predictive value, sensitivity, F 1 scores, area under the receiver operating curve (AUC), calibration plots, and explainability plots. ResultsAll models showed strong performance (AUC 0.81–0.95). The best performing was the model that incorporated age at diagnosis for each chronic condition developed at or before age 60 years (AUC 0.95, 95% confidence interval 0.94–0.96). Salient features for predicting premature death were young ages of diagnosis for mood disorder, osteo-and other arthritis types, other mental health disorders, and hypertension, as well as male sex. InterpretationBy comparing results from multiple approaches modelling the impact of chronic conditions on premature death among people with IBD, we showed that conditions developed early in life (age ≤ 60 yr) and their age of onset were important for predicting their health trajectory. Clinically, our findings emphasize the need for models of care that ensure people with IBD have access to high-quality, multidisciplinary health care.