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Just over 50 years ago, Avedis Donabedian published his seminal paper, which sought to define and specify the ‘quality of health care’, articulating the now paradigmatic triad of structure, process and outcome for measuring healthcare quality.1 In recent years, we have seen the rapid expansion of increasingly inexpensive information technology capability and capacity, facilitating the collection and analysis of large healthcare data sets. These technological advances fuel the current proliferation of performance measurement in healthcare.2 Increasingly, in an effort to improve care, many cancer health systems, including those in England,3 the USA4 and Canada,5 6 are publicly reporting performance indicators, generally derived from these large data sets. Not surprisingly, differences in prevention, early detection and/or treatment of cancer are often used to explain the observed differences in performance across jurisdictions.6–9 Given the considerable effort and resource invested in performance measurement as well as potential adverse consequences if done poorly,10 it is important to get it right. Determining the effectiveness of healthcare performance measurement is challenging,11 particularly at the health system level. Often, performance measurement is implemented uniformly across an entire system, making well-designed controlled analysis less feasible or impossible12 13 and leaving evaluations vulnerable to secular trends.14 At the physician level, audit and feedback studies report variable results: meta-analyses show a modest benefit overall,15–17 but an important proportion of interventions were ineffective or minimally effective with a few studies suggesting a negative effect on performance.16 Likely, this heterogeneity is due to the complexity of the endeavour and its many moving parts, which include the behaviour targeted, the recipients of the feedback, their environment, the use of cointerventions and the components of the audit and feedback intervention itself.18 The latter generally comprises performance indicators, often derived from large healthcare data sets; however, …

Objective To evaluate the association between repeated faecal occult blood testing and advanced colorectal cancer risk at population level in Canada. Methods A retrospective cohort study of all Ontario residents aged 56–74 diagnosed with colorectal cancer from 1 April 2007 to 31 March 2010, identified using health administrative data. The primary outcome was stage IV colorectal cancer, and primary exposure was faecal occult blood testing use within five years prior to colorectal cancer diagnosis. Patients were categorized into four mutually exclusive groups based on their exposure to faecal occult blood testing in the five years prior to colorectal cancer diagnosis: none, pre-diagnostic, repeated, and sporadic. Logistic regression was utilized to adjust for confounders. Results Of 7753 patients (median age 66, interquartile range 61–70, 62% male) identified, 1694 (22%) presented with stage I, 2056 (27%) with stage II, 2428 (31%) with stage III, and 1575 (20%) with stage IV colorectal cancer. There were 4092 (53%) with no record of prior faecal occult blood testing, 1485 (19%) classified as pre-diagnostic, 1693 (22%) as sporadic, and 483 (6%) as repeated faecal occult blood testing. After adjusting for confounders, patients who had repeated faecal occult blood testing were significantly less likely to present with stage IV colorectal cancer at diagnosis (Odds ratio 0.46, 95% Confidence Interval 0.34–0.62) than those with no prior faecal occult blood testing. Conclusions Repeated faecal occult blood testing is associated with a decreased risk of advanced colorectal cancer. Our findings support the use of organized screening programmes that employ repeated faecal occult blood testing to improve colorectal cancer outcomes at population level.

Background The risk of colorectal cancer (CRC) varies around the world and between females and males. We aimed to compare the risk of CRC among immigrants to Ontario, Canada, to its general population. Methods We used an exposure-control matched design. We identified persons in the Immigration, Refugees and Citizenship Canada Permanent Resident Database with first eligibility for the Ontario Health Insurance Plan between July 1, 1991 and June 30, 2008 at age 40 years or older, and matched five controls by year of birth and sex on the immigrant’s first eligibility date. We identified CRC from the Ontario Cancer Registry between the index date and December 31, 2014. All analyses were stratified by sex. We calculated crude and relative rates of CRC. We estimated risk of CRC over time by the Kaplan-Meier method and compared immigrants to controls in age and sex stratified strata using log-rank tests. We modeled the hazard of CRC using Cox proportional hazards regression, accounting for within-cluster correlation by a robust sandwich variance estimation approach, and assessed an interaction with time since eligibility. Results Among females, 1877 cases of CRC were observed among 209,843 immigrants, and 16,517 cases among 1,049,215 controls; the crude relative rate among female immigrants was 0.623. Among males, 1956 cases of CRC were observed among 191,792 immigrants and 18,329 cases among 958,960 controls; the crude relative rate among male immigrants was 0.582.. Comparing immigrants to controls in all age and sex stratified strata, the log rank test p = 75 years at index, where p = 0.01. The age-adjusted hazard ratio (HR) for CRC among female immigrants was 0.63 (95% CI 0.59, 0.67) during the first 10 years, and 0.66 (95% CI 0.59, 0.74) thereafter. Among male immigrants the age-adjusted HR = 0.55 (95% CI 0.52, 0.59) during the first 10 years and increased to 0.63 (95% CI 0.57, 0.71) thereafter. The adjusted HR > = 1 only among immigrants born in Europe and Central Asia. Conclusions The risk of CRC among immigrants to Ontario relative to controls varies by origin and over time since immigration.

Corrigendum: Do Primary Care Provider Strategies Improve Patient Participation in Colorectal Cancer Screening?

Background: Timely follow-up of fecal occult blood screening with colonoscopy is essential for achieving colorectal cancer mortality reduction. In the present study, we evaluated the effectiveness of centrally generated, physician-targeted audit and feedback to improve colonoscopy uptake after a positive fecal occult blood test (fobt) result within Ontario’s population-wide ColonCancerCheck Program. Methods: This prospective cohort study used data sets from Ontario’s ColonCancerCheck Program (2008–2011) that were linked to provincial administrative health databases. Cox proportional hazards regression was used to estimate the effect of centralized, physician-targeted audit and feedback on colonoscopy uptake in an Ontario-wide fobt-positive cohort. Results: A mailed physician audit and feedback report identifying individuals outstanding for colonoscopy for 3 or more months after a positive fobt result did not increase the likelihood of colonoscopy uptake (hazard ratio: 0.95; 95% confidence interval: 0.79 to 1.13). Duration of positive fobt status was strongly inversely associated with the hazard of follow-up colonoscopy (p for linear trend

Background & Aims The increase in use of anesthesia assistance (AA) to achieve deep sedation with propofol during colonoscopy has significantly increased colonoscopy costs without evidence for increased quality and with possible harm. We investigated the effects of AA on colonoscopy complications, specifically bowel perforation, aspiration pneumonia, and splenic injury. Methods In a population-based cohort study using administrative databases, we studied adults in Ontario, Canada undergoing outpatient colonoscopy from 2005 through 2012. Patient, endoscopist, institution, and procedure factors were derived. The primary outcome was bowel perforation, defined using a validated algorithm. Secondary outcomes were splenic injury and aspiration pneumonia. Using a matched propensity score approach, we matched persons who had colonoscopy with AA (1:1) with those who did not. We used logistic regression models under a generalized estimating equations approach to explore the relationship between AA and outcomes. Results Data from 3,059,045 outpatient colonoscopies were analyzed; 862,817 of these included AA. After propensity matching, a cohort of 793,073 patients who had AA and 793,073 without AA was retained for analysis (51% female; 78% were age 50 years or older). Use of AA did not significantly increase risk of perforation (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.84–1.16) or splenic injury (OR, 1.09; 95% CI, 0.62–1.90]. Use of AA was associated with an increased risk of aspiration pneumonia (OR, 1.63; 95% CI, 1.11–2.37). Conclusions In a population-based cohort study, AA for outpatient colonoscopy was associated with a significantly increased risk of aspiration pneumonia, but not bowel perforation or splenic injury. Endoscopists should warn patients, especially those with respiratory compromise, of this risk.

BACKGROUND The prevalence of self-reported gastrointestinal (GI) symptoms and distress is high, but few studies have quantified their impact on health-related quality of life (HRQoL). METHODS We conducted a prospective cohort study of patients with HIV in care in Ontario, Canada (2007-2014). General linear mixed models were used to assess the impact of GI symptoms (diarrhea/soft stool, nausea/vomiting, bloating/painful abdomen, loss of appetite, weight loss/wasting) and distress (range: 0-4) on physical and mental HRQoL summary scores (range: 0-100) measured by the Medical Outcomes Survey SF-36. RESULTS A total of 1787 participants completed one or more questionnaires {median 3 [interquartile range (IQR): 1-4]}. At baseline, 59.0% were men who had sex with men, 53.7% white, median age 45 (IQR: 38-52), median CD4 count 457 (IQR: 315-622), and 71.0% had undetectable HIV viremia. The mean (standard deviation [SD]) mental and physical HRQoL scores were 49.2 (8.6) and 45.3 (13.0), respectively. In adjusted models, compared with those reporting no symptoms, all GI symptom distress scores from 2 ("have symptom, bothers me a little") to 4 ("have symptom, bothers a lot") were associated with lower mental HRQoL. Loss of appetite distress scores ≥ 1; scores ≥ 2 for diarrhea, nausea/vomiting, and bloating; and a score ≥ 3 for weight loss were independently associated with lower physical HRQoL scores (P < 0.0001). Increasing GI symptom distress is associated with impaired mental and physical HRQoL (P < 0.0001). CONCLUSIONS Increasing GI symptom distress is associated with impaired mental and physical HRQoL. Identifying, treating, and preventing GI symptoms may reduce overall symptom burden and improve HRQoL for patients with HIV.

Background The ColonCancerCheck screening program for colorectal cancer (CRC) in Ontario, Canada, is considering switching from biennial guaiac fecal occult blood test (gFOBT) screening between age 50±74 years to the more sensitive, but also less specific fecal immunochemical test (FIT). The aim of this study is to estimate whether the additional benefits of FIT screening compared to gFOBT outweigh the additional costs and harms. Methods We used microsimulation modeling to estimate quality adjusted life years (QALYs) gained and costs of gFOBT and FIT, compared to no screening, in a cohort of screening participants. We compared strategies with various age ranges, screening intervals, and cut-off levels for FIT. Cost-efficient strategies were determined for various levels of available colonoscopy capacity. Results Compared to no screening, biennial gFOBT screening between age 50±74 years provided 20 QALYs at a cost of CAN$200,900 per 1,000 participants, and required 17 colonoscopies per 1,000 participants per year. FIT screening was more effective and less costly. For the same level of colonoscopy requirement, biennial FIT (with a high cut-off level of 200 ng Hb/ ml) between age 50±74 years provided 11 extra QALYs gained while saving CAN$333,300 per 1000 participants, compared to gFOBT. Without restrictions in colonoscopy capacity, FIT (with a low cut-off level of 50 ng Hb/ml) every year between age 45±80 years was the most cost-effective strategy providing 27 extra QALYs gained per 1000 participants, while saving CAN$448,300. Interpretation Compared to gFOBT screening, switching to FIT at a high cut-off level could increase the health benefits of a CRC screening program without considerably increasing colonoscopy demand.

Regular screening using guaiac fecal occult blood test (gFOBT) reduces mortality from colorectal cancer (CRC). The objective of this study was to determine whether the addition of a gFOBT kit to a second mailed invitation compared to a second mailed invitation alone increases CRC screening among eligible persons who did not respond to an initial mailed invitation. We conducted a cluster randomized controlled trial, with the physician as the unit of randomization. Participants were persons who had been invited but who had not responded to an invitation for CRC screening in an earlier pilot project. The intervention group received a mailed gFOBT kit and second mailed CRC screening invitation (n = 2,008) while the control group received a second mailed CRC screening invitation alone (n = 1,586). The primary outcome was the uptake of gFOBT within 6 months of the second mailing. We found that the uptake of gFOBT was more than twice as high in the intervention group (20.1%) compared to the control group (9.6%). The absolute difference between the two groups was 10.5% (95% CI: 7.5-13.4%, p ≤ 0.0001). In a subsequent adjusted analysis, participants in the intervention group were twice as likely to complete the test as those in the control group (OR = 2.1; 95% CI: 1.6-2.6). These findings suggest that directly mailed gFOBT kits increase CRC screening participation among previous nonresponders to a mailed invitation and that approximately 10 gFOBT kits would have to be sent by mail in order to screen 1 additional person. (ClinicalTrials.gov: NCT01629004).

There is a lack of existing literature regarding the quality of esophagogastroduodenoscopy (EGD) reporting for gastric cancer evaluation. This study aims to determine criteria for quality endoscopic evaluation of gastric cancer in North America by identifying important features of the EGD report for pre-operative evaluation of gastric cancer and assessing inclusion of these features in existing reports. Semi-structured interviews were conducted with experienced endoscopists from community and academic hospitals affiliated with the University of Toronto to identify essential elements for an EGD report. Then, 225 EGD reports from 2005 to 2008 were evaluated by two trained reviewers for inclusion of recommended EGD report elements and global assessment of report quality and adequacy for surgical planning. Essential elements recommended by interviewed endoscopists include tumor size, location, and distance from gastroesophageal junction (GEJ). Approximately 95 % of all reports documented the location of lesions

Although colorectal cancer is a leading cause of death in Canada, it is curable if detected in the early stages. Flexible sigmoidoscopy has been shown to reduce the incidence and mortality of colorectal cancer in patients who are at average risk for this disease and, therefore, is an appropriate screening intervention. Moreover, it may be performed by nonphysicians. A program to enable registered nurses to perform flexible sigmoidoscopy to increase colorectal cancer screening capacity in Ontario was developed. This program incorporated practical elements learned from other jurisdictions as well as specific regional considerations to fit within the health care system of Ontario. The nurses received structured didactic and simulation training before performing sigmoidoscopies on patients under physician supervision. After training, nurses were evaluated by two assessors for their ability to perform complete sigmoidoscopies safely and independently. To date, 17 nurses have achieved independence in performing flexible sigmoidoscopy at 14 sites. In total, nurses have screened >7000 Ontarians, with a cancer detection rate of 5.1 per 1000 screened, which is comparable with rates in other jurisdictions and with sigmoidoscopy performed by gastroenterologists, surgeons and other trained nonphysicians. We have shown, therefore, that with proper training and program structure, registered nurses are able to perform flexible sigmoidoscopy in a safe and thorough manner resulting in a significant increase in access to colorectal cancer screening.

OBJECTIVES: Few have compared socio-economic disparities in screening tests for cancer with recommended tests for other chronic diseases. We examined whether receipt of testing for colorectal, cervical and breast cancer, as well as diabetes and high cholesterol, differs by neighbourhood-level socio-economic and recent immigrant status. METHODS: We conducted a population-based retrospective cohort study of patients identified as screen-eligible in 2009 living in Ontario, Canada. Postal codes were used to assign residents to a dissemination area (DA). Using Canadian census data, DAs were stratified by income quintile and proportion of recent immigrants. Prevalence of screening for cancer (colorectal, cervical, breast), diabetes, and high cholesterol, using administrative data, and prevalence ratios (least/most advantaged) were calculated. RESULTS: The cohort comprised 7,652,592 people. Receipt of screening for colorectal cancer (women 61.6%; men 55.1%) and breast cancer (59.9%) were the lowest and diabetes (women 72.9%; men 61.4%) and high cholesterol (women 82.4%; men 70.3%) were the highest. We found disparities in the receipt of all tests, with the lowest uptake and largest disparities for cancer screening among those living in both low-income and high-immigration DAs: colorectal – women 48.6%; RR 0.77; 95% CI (0.74-0.79) and men 40.6%; RR 0.71 (0.68-0.74); cervical – 52.0%; RR 0.80 (0.78-0.81) and breast – 45.7%; RR 0.74 (0.72-0.77). CONCLUSION: People living in low-income and high-immigration DAs had the lowest screening participation for all tests, although disparities were highest for cancer. An organized integrated chronic disease screening strategy leveraging the higher diabetes and high cholesterol screening participation may increase screening for cancer and other chronic diseases in never- and underscreened populations.

The approach for staging gastric adenocarcinoma (GC) has not been well defined, with heterogeneity in the application of staging modalities.Utilizing a RAND/UCLA appropriateness methodology (RAM), a multidisciplinary expert panel of 16 physicians scored 84 GC staging scenarios. Appropriateness was scored from 1 to 9. Median appropriateness scores from 1 to 3 were considered inappropriate, 4-6 uncertain, and 7-9 appropriate. Agreement was reached when 12 or more of 16 panelists scored the scenario similarly. Appropriate scenarios were subsequently scored for necessity.Pretreatment TNM stage determination is necessary. Necessary staging maneuvers include esophagogastroduodenoscopy (EGD); biopsy of the tumor; documentation of tumor size, description, location, distance from gastroesophageal junction (GEJ), and any GEJ, esophageal, or duodenal involvement; if an EGD report is unclear, surgeons should repeat it to confirm tumor location. Pretreatment radiologic assessment should include computed tomography (CT)-abdomen and CT-pelvis, performed with multidetector CT scanners with 5-mm slices. Laparoscopy should be performed before resection of cT3-cT4 lesions or multivisceral resections. Laparoscopy should include inspection of the stomach, diaphragm, liver, and ovaries.Using a RAM, we describe appropriate and necessary staging tests for the pretreatment staging evaluation of GC, as well as how some of these staging maneuvers should be conducted.

BACKGROUND Open-access (OA) colonoscopy may increase efficiency and decrease wait times; however, because the patient is seen for the first time at the endoscopy appointment, previous processes, such as information about the procedure, preparation and appropriate triage, may be suboptimal.OBJECTIVE: To identify factors associated with OA colonoscopy and to determine the relationship between OA colonoscopy and an important quality measure, incomplete colonoscopy.METHODS: A population-based analysis of all adult outpatients undergoing a first-time colonoscopy between 1997 and 2007 in Ontario was performed. Colonoscopy was considered to be OA if there were no visits in the preceding five years with the physician performing the colonoscopy. Using logistic regression, patient, physician and institution factors associated with OA colonoscopy were identified. Using propensity score matching, the relationship between OA colonoscopy and incomplete colonoscopy in 2006 was examined.RESULTS: A total of 1,079,259 colonoscopies were performed. Of these, 14% were OA in 1997 compared with 26% in 2007. Patients 50 to 69 years of age, those from higher-income neighbourhoods and those with less comorbidity were more likely to undergo OA colonoscopy. The odds of receiving OA colonoscopy were six times greater in a nonhospital clinic compared with a community hospital. Colonoscopy was more likely to be complete if the procedure was OA (OR 1.3 [95% CI 1.2 to 1.4]; PCONCLUSIONS: Rates of OA colonoscopy have increased substantially since 1997. Institution type was most strongly associated with OA colonoscopy. Colonoscopy completeness, a recognized quality indicator, does not appear to be compromised by OA colonoscopy.

Summary Background Clostridium difficile colitis (CDC) is associated with an increased short-term mortality risk in hospitalised ulcerative colitis (UC) patients. We sought to determine whether CDC also impacts long-term risks of adverse health events in this population. Aim To determine whether CDC also impacts long-term risks of adverse health events in this population. Methods A population-based retrospective cohort study was conducted of UC patients hospitalised in Ontario, Canada between 2002 and 2008. Patients with and without CDC were compared on the rates of adverse health events. The primary outcomes were the 5-year adjusted risks of colectomy and death. Results Among 181 patients with CDC and 1835 patients without CDC, the 5-year cumulative colectomy rates were 44% and 33% (P = 0.0052) and the 5-year cumulative mortality rates were 27% and 14% (P

Introduction. The objectives of this systematic review were to evaluate the evidence for different CRC screening tests and to determine the most appropriate ages of initiation and cessation for CRC screening and the most appropriate screening intervals for selected CRC screening tests in people at average risk for CRC.Methods. Electronic databases were searched for studies that addressed the research objectives. Meta-analyses were conducted with clinically homogenous trials. A working group reviewed the evidence to develop conclusions.Results. Thirty RCTs and 29 observational studies were included. Flexible sigmoidoscopy (FS) prevented CRC and led to the largest reduction in CRC mortality with a smaller but significant reduction in CRC mortality with the use of guaiac fecal occult blood tests (gFOBTs). There was insufficient or low quality evidence to support the use of other screening tests, including colonoscopy, as well as changing the ages of initiation and cessation for CRC screening with gFOBTs in Ontario. Either annual or biennial screening using gFOBT reduces CRC-related mortality.Conclusion. The evidentiary base supports the use of FS or FOBT (either annual or biennial) to screen patients at average risk for CRC. This work will guide the development of the provincial CRC screening program.

In the modern antiretroviral (ARV) era, there is limited knowledge about the prevalence and risk factors for HIV patient-reported gastrointestinal (GI) symptoms (diarrhoea/soft stool, nausea/vomiting, bloating/painful abdomen, loss of appetite, and weight loss/wasting) and distress. We prospectively analysed data (2007-2014) on distressing GI symptoms from the Ontario HIV Treatment Network Cohort Study, which follows people attending HIV clinics. Using generalized estimating equations with a logit link, we estimated the associations of psychosocial, demographic, behavioural, and clinical factors with each GI symptoms compared to asymptomatic and non-bothersome symptoms. Among 1532 included participants, 80.4% were male, mean age was 45 years, and 64.6% reported being men who have sex with men. Most were Caucasian (56.3%), a median time since HIV diagnosis of 9.8 years (interquartile range (IQR): 4.1-16.9), and 83.1% were on ARV. More than two-thirds (68.7% (95% confidence intervals (CI): 63.1% to 69.2%)) reported one or more symptoms with a median of 1.2 (IQR: 0-1.7). The proportion remained stable over time since HIV diagnosis and ARV initiation. Risk factors varied for multivariable models. A strong association with Centre for Epidemiologic Studies Depression scale scores of ≥23 was found for all symptoms. Adjusted odds ratios (95% CI) were 1.72 (1.39-2.12), 2.95 (2.33-3.72), 2.20 (1.81-2.68), 4.97 (3.99-6.19), and 2.98 (2.52-3.82) for diarrhoea, nausea/vomiting, bloating, loss of appetite, and weight loss, respectively. With the exception of bloating, odds were significantly lower for those on ARV containing integrase inhibitors and greater for patients reporting current cannabis use. GI symptoms in the modern ARV era are highly prevalent and may arise as a common pathway of distress in response to psychosocial vulnerabilities, regardless of the stage of diagnosis. These findings support the need for integrated approaches to address psychological and physical distress in HIV disease.

Objective To derive a taxonomy for colorectal cancer screening that advances Randomized Controlled Trials (RCTs) and screening uptake. Design Detailed publication review, multiple interviews with principal investigators (PIs) and collaboration with PIs as co-authors produced a CRCS intervention taxonomy. Semi-structured interview questions with PIs (Drs. Inadomi, Myers, Green, Gupta, Jerant and Ritvo) yielded details about trial conduct. Interview comparisons led to an iterative process informing serial interviews until a consensus was obtained on final taxonomy structure. Results These taxonomy headings ( E ngagement Sponsor, P opulation Targeted, A lternative Screening Tests, D elivery Methods, and S upport for Test Performance ( EPADS )) were used to compare studies. Exemplary insights emphasized: 1) direct test delivery to patients; 2) linguistic-ethnic matching of staff to minority subjects; and 3) authorization of navigators to schedule or refer for colonoscopies and/or distribute stool blood tests during screening promotion. Conclusion PIs of key RCTs (2012–2015) derived a CRCS taxonomy useful in detailed examination of CRCS promotion and design of future RCTs.

Background Screening for cervical, breast and colon cancers, and elevations of cholesterol and glucose, reduces premature cause-specific mortality from these cancers and circulatory diseases. Despite primary care reforms and incentives, and promotion of cancer-screening programs among individuals, participation is suboptimal. We aimed to examine participation as of Dec. 31, 2011, by factors of deprivation, demographics and primary care at the small-area level. Methods From health care administrative databases, we identified people eligible for each screening test, and their participation, in each dissemination area (referred to as small areas, n = 18 950) in Ontario. We calculated rates for each test among small areas (overall and stratified by demographic, socioeconomic and primary care descriptors) and stratified by sex for all tests combined. We loaded all data into a geographic information system. Funnel plots were generated showing the percentage of eligible people who completed screening for all tests by small area, stratified by sex. Overall and stratified screening prevalence ratios were calculated among small areas. Results Among small areas, the mean and SD for participation in all tests combined was 31.6% (SD 11.0%) for women and 41.2% (SD 12.0%) for men. Screening prevalence among small areas, for each test and for all tests combined, overall and stratified by sex, declined with decreasing percentage with high school completion, decreasing socioeconomic quintile, and decreasing percentage with an identifiable primary care physician. Interpretation Our results show that the rate of participation in all eligible screening tests among small areas is much lower than the rate of participation in any one particular test. This finding has implications for the design and implementation of strategies to improve rates of screening.

Background.This work examines the occurrence of interval colorectal cancers (CRCs) in the Ontario ColonCancerCheck (CCC) program. We define interval CRC as CRC diagnosed within 2 years following normal guaiac fecal occult blood testing (gFOBT).Methods.Persons aged 50–74 who completed a baseline CCC gFOBT kit in 2008 and 2009, without a prior history of CRC, or recent colonoscopy, flexible sigmoidoscopy, or gFOBT, were identified. Rates of CRC following positive and normal results at baseline and subsequent gFOBT screens were computed and overall survival was compared between those following positive and normal results.Results.Interval CRC was diagnosed within 24 months following the baseline screen among 0.16% of normals and following the subsequent screen among 0.18% of normals. Interval cancers comprised 38.70% of CRC following the baseline screen and 50.86% following the subsequent screen. Adjusting for age and sex, the hazard ratio (HR) for death following interval cancer compared to CRC following positive result was 1.65 (1.32, 2.05) following the first screen and 1.71 (1.00, 2.91) following the second screen.Conclusion.Interval CRCs following gFOBT screening comprise a significant proportion of CRC diagnosed within 2 years after gFOBT testing and are associated with a higher risk of death.

Self-expandable stents for obstructing colorectal cancer (CRC) offer an alternative to operative management. The objective of the study was to determine stent utilization for CRC obstruction in the province of Ontario between April 1, 2000, and March 30, 2009. Colonic stent utilization characteristics, poststent insertion health outcomes, and health care encounters were recorded. 225 patients were identified over the study period. Median age was 69 years, 2/3 were male, and 2/3 had metastatic disease. Stent use for CRC increased over the study period and gastroenterologists inserted most stents. The median survival after stent insertion was 199 (IQR, 69–834) days. 37% of patients required an additional procedure. Patients with metastatic disease were less likely to go on to surgery (HR 0.14, 95% CI 0.06–0.32,p<0.0001). There were 2.4/person-year emergency department visits (95% CI 2.2–2.7) and 2.3 hospital admissions/person-year (95% CI 2.1–2.5) following stent insertion. Most admissions were cancer or procedure related or for palliation. Factors associated with hospital admissions were presence of metastatic disease, lack of chemotherapy treatment, and stoma surgery. Overall the use of stents for CRC obstruction remains low. Stents are predominantly used for palliation with low rates of postinsertion health care encounters.

Objectives Crohn's disease (CD) patients frequently require surgery. We sought to characterize postoperative health-care utilization and its impact on outcomes. Methods We assembled a population-based cohort of CD patients who underwent first surgery in Ontario, Canada, between 1996 and 2009. We compared intra-individual preoperative and postoperative health-care utilization and characterized utilization of early postoperative gastrointestinal care (EPGIC) and its impact on health outcomes. Results For the 2,943 CD patients who underwent surgery, the 5-year risk of recurrent surgery was 26%. In the 5th postoperative year, the average annual number of inflammatory bowel disease (IBD)-related clinic visits, emergency department visits, endoscopy procedures, radiological procedures, and hospitalizations decreased by 62, 62, 82, 78, and 89% compared with prior to surgery. Regional utilization of EPGIC varied between 18 and 62% and correlated with the number of gastroenterologists within a regional local health integration network (ρ=0.71; P=0.006). EPGIC was associated with reduced risk of late postoperative CD-related hospitalizations (at least 1 year after surgery; adjusted incidence ratio (IRR), 0.82; 95% confidence interval (CI): 0.72-0.94). Other predictors of late hospitalizations included having an emergency department visit within 6 months (adjusted IRR, 2.60; 95% CI: 2.21-3.05), lower income, and higher comorbidity. Individuals residing in regions with high aggregate EPGIC utilization experienced lower rates of hospitalization compared with those in regions with low utilization (adjusted IRR, 0.83; 95% CI: 0.70-0.95). Conclusions IBD-related health-care utilization decreased significantly up to 5 years following surgery. EPGIC may reduce late CD-related hospitalizations following surgery.

To evaluate the impact of in-hospital gastroenterologist care, relative to other provider care, on health outcomes of hospitalised Ulcerative colitis (UC) patients.A population-based cohort study of 4278 UC patients hospitalised between 2002 and 2008 was conducted in Ontario, Canada. The primary outcome was in-hospital mortality risk.UC patients admitted under non-gastroenterologists had a higher in-hospital mortality rate (1.1 vs 0.2%, p0.0001) but a similar in-hospital colectomy rate (5.4 vs 4.9%, p=0.69) as compared to UC patients admitted under gastroenterologists. Following covariate adjustment, non-gastroenterologist care was associated with a greater in-hospital mortality risk relative to gastroenterologist care (adjusted OR (aOR) 3.28, 95% CI 1.03 to 10.5). This increased mortality risk was observed in patients admitted to other internists (OR 5.49, 95% CI 1.75 to 17.2) and general practitioners (OR 6.02, 95% CI 1.84 to 19.7), with a trend towards greater mortality risk among patients admitted to general surgeons (OR 3.49, 95% CI 0.90 to 13.6). Among patients who were discharged from hospital colectomy-free, those who were admitted under non-gastroenterologists had a greater one-year risk of death than patients who were admitted under gastroenterologists (adjusted HR 2.07, 95% CI 1.26 to 3.40). The type of hospital provider did not impact in-hospital or one-year colectomy risks or the risk of hospital re-admission in this cohort.Primary in-hospital gastroenterologist care was associated with decreased in-hospital and one-year mortality risks among hospitalised UC patients. Optimised care strategies by experienced specialists may confer important health advantages in this patient population.

Background Accurate preoperative staging is important in determining the appropriate treatment of gastric cancer. Recently, endoscopic ultrasound (EUS) has been introduced as a staging modality. However, reported test characteristics for EUS in gastric cancer vary. Our purpose in this study was to identify, synthesize, and evaluate findings from all articles on the performance of EUS in the preoperative staging of gastric cancer.

To assess the cost-effectiveness of high-resolution anoscopy (HRA), anal cytology, and anal human papillomavirus (HPV) detection in screening for histologic high-grade anal intraepithelial neoplasia (AIN 2/3) in HIV-positive MSM.Participants were 401 HIV-positive MSM who were screened for anal cancer in a tertiary care HIV clinic.A decision analytical model was used to determine the cost-effectiveness of three anal cancer screening strategies: the direct use of HRA; HRA only if anal cytology was abnormal; and HRA only if oncogenic HPV was present. The model included the use of different thresholds for abnormal cytology and also combined cytology and HPV testing. The outcome was the number of AIN 2/3 cases detected. Costs were estimated from institutional data and sensitivity/specificity of cytology and HPV tests were obtained from the screening study.The costs ($ US) per procedure for HRA, cytology, and HPV testing were $193, $90, and $95, respectively. The direct use of HRA was the most cost-effective strategy. It detected 98 individuals with AIN 2/3 and had a cost-effectiveness of $809 per AIN 2/3 case detected. Using probabilistic sensitivity analysis, three other strategies had similar costs per case detected and might be as cost-effective as HRA.In HIV-infected MSM, the direct use of HRA is the most cost-effective strategy for detecting AIN 2/3. The higher cost per use for HRA was offset by the high sensitivity and low specificity of HPV and cytology testing.

BACKGROUND: Although colonoscopy is increasingly performed in nonhospital facilities, studies to date examining differences between colonoscopy services in hospital and nonhospital settings have been limited, in large part, to administrative databases.OBJECTIVES: To describe the experiences of patients receiving colonoscopy in hospital and nonhospital settings, and to compare these settings with respect to wait times and recommended follow-up interval to the next colonoscopy.METHODS: A postal survey of 2000 patients, 50 to 70 years of age, from an urban academic family practice was conducted. Most recent colonoscopy was classified as either occurring in a hospital or nonhospital setting. Multivariable logistic regression analysis was used to examine the association among wait times, follow-up intervals and patient factors with respect to colonoscopy setting.RESULTS: Patients who underwent their most recent colonoscopy outside of a hospital were more likely to be men (P=0.01) and to have undergone more than one previous colonoscopy (P=0.02). For patients with a normal screening colonoscopy and no family history of colorectal cancer or polyps, nonhospital clinics less often recommended a 10-year follow-up interval (OR 0.13 [95% CI 0.04 to 0.47]). Reported wait times at nonhospital clinics were shorter for patients receiving screening colonoscopy (OR 2.11 [95% CI 1.28 to 3.47]), but not for symptomatic patients (OR 1.74 [95% CI 0.88 to 3.43]). For individuals attending nonhospital clinics, 10% were referred from a hospital by the same specialist performing the procedure; 31.7% reported paying a fee.CONCLUSION: Nonhospital clinics were far less likely to adhere to guidelines regarding follow-up intervals for low-risk patients. Given the implications for both health care costs and patient safety, further study is needed to determine the cause of this disparity.

Background: Providing clinical performance data to health professionals, a process known as audit and feedback, can play an important role in health system improvement. However, audit and feedback tools can only be effective if the targeted health professionals access and actively review their data. Email is used by Cancer Care Ontario, a provincial cancer agency, to promote access to a Web-based audit and feedback tool called the Screening Activity Report (SAR); however, current emails that lack behavior change content have been ineffective at encouraging log-in to the SAR. Objective: The objective of our study was to describe the process and experience of developing email content that incorporates user input and behavior change techniques (BCTs) to promote the use of the SAR among Ontario primary care providers. Methods: Our interdisciplinary research team first identified BCTs shown to be effective in other settings that could be adapted to promote use of the SAR. We then developed draft BCT-informed email content. Next, we conducted cocreation workshops with physicians who had logged in to the SAR more than once over the past year. Participants provided reactions to researcher-developed BCT-informed content and helped to develop an email that they believed would prompt their colleagues to use the SAR. Content from cocreation workshops was brought to focus groups with physicians who had not used the SAR in the past year. We analyzed notes from the cocreation workshops and focus groups to inform decisions about content. Finally, 8 emails were created to test BCT-informed content in a 2×2×2 factorial randomized experiment. Results: We identified 3 key tensions during the development of the email that required us to balance user input with scientific evidence, organizational policies, and our scientific objectives, which are as follows: conflict between user preference and scientific evidence, privacy constraints around personalizing unencrypted emails with performance data, and using cocreation methods in a study with the objective of developing an email that featured BCT-informed content. Conclusions: Teams tasked with developing content to promote health professional engagement with audit and feedback or other quality improvement tools might consider cocreation processes for developing communications that are informed by both users and BCTs. Teams should be cautious about making decisions solely based on user reactions because what users seem to prefer is not always the same as what works. Furthermore, implementing user recommendations may not always be feasible. Teams may face challenges when using cocreation methods to develop a product with the simultaneous goal of having clearly defined variables to test in later studies. The expected role of users, evidence, and the implementation context all warrant consideration to determine whether and how cocreation methods could help to achieve design and scientific objectives.

Background: Regular screening for colorectal cancer (CRC) is associated with a lower stage at diagnosis and improved survival. National guidelines recommend periodic screening for adults aged 50-74 years. Chronic diseases may distract from regular screening and increase CRC burden. We sought to determine whether having certain chronic conditions is associated with a lower rate of CRC screening adherence. Methods: Using linked healthcare databases from Ontario, Canada, we assembled a population-based cohort of adults aged 50-74 years, who were eligible and overdue for routine CRC screening (fecal occult blood testing > 2 years, sigmoidoscopy > 5 years, or colonoscopy > 10 years) at any point between April 1, 2004 and March 31, 2016. We implemented Andersen-Gill extended Cox models for recurrent events using an age time scale to examine the impact of chronic conditions on the relative rate (RR, 95% confidence interval, CI) of becoming adherent with periodic CRC tests, adjusted for the relevant time-varying covariates. Results: During the 12-year observation window, included individuals contributed a total of 19,818,050 person-years spent overdue for CRC tests. Over 70% of all CRC tests performed during the study period were fecal occult blood tests. At baseline, of the 4,642,422 individuals that met the inclusion criteria, 31% had hypertension, 12% had diabetes, 9% had chronic obstructive pulmonary disease (COPD), 7% had mental illness, 5% had cardiovascular disease (CVD), 1.6% had congestive heart failure (CHF), and 0.1% had end-stage renal disease (ESRD). After adjustment for sociodemographic and health system factors, the highest rates of nonadherence were observed for ESRD on dialysis (RR 0.66, CI 0.63-0.68), CHF (RR 0.75, CI 0.75-0.76), COPD (RR 0.84, CI 0.83-0.84), CVD (RR 0.85, CI 0.84-0.85), diabetes (RR 0.86, CI 0.86-0.87), and mental illness (RR 0.88, CI 0.87-0.88). Hypertension (RR 0.98, CI 0.97-0.98) and ESRD with kidney transplant (RR 1.00, CI 0.84-1.19) were associated with modest to no risk. Conclusion: The presence of a major chronic condition is associated with lower adherence to CRC screening. Future studies should explore reasons for lower CRC screening adherence in individuals with chronic conditions and the appropriateness of secondary cancer prevention and early diagnosis in this population. Citation Format: Dominika Bhatia, Rinku Sutradhar, Jill Tinmouth, Simron Singh, Lorraine Lipscombe. Influence of chronic comorbidities on colorectal cancer screening adherence in a population-based Canadian cohort [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2204.

Background and Aims Colorectal cancers (CRCs) diagnosed between 6 and 36 months after colonoscopy, termed postcolonoscopy CRCs (PCCRCs), arise primarily due to missed or inadequately treated neoplasms during colonoscopy. Introduction of multiple quality indicators and technological advances to colonoscopy practice should have reduced the PCCRC rate over time. We assessed temporal trends in the population rate of PCCRC as a measure of changing colonoscopy quality. Methods We conducted a population-based retrospective cohort study of persons aged 50 to 74 years without advanced risk factors for CRC who underwent complete colonoscopy in Ontario, Canada between 1996 and 2010. We defined the PCCRC rate as the proportion of individuals diagnosed with CRC within 36 months of colonoscopy that had PCCRC. We compared age-adjusted and sex-adjusted rates of PCCRC over time based on 3 periods (1996-2001, 2001-2006 and 2006-2010) and assessed the independent association between time period and PCCRC risk through multivariable regression, with respect to all PCCRCs, proximal PCCRC and distal PCCRC. Results There was a marked increase in colonoscopy volumes over the study period, particularly in younger age groups and non-hospital settings. Among 1,093,658 eligible persons the PCCRC rate remained stable at approximately 8% over the 15-year study period. The adjusted odds of PCCRC, distal PCCRC and proximal PCCRC, comparing the 2006 to 2010 period with the 1996 to 2001 period, were 1.14 (95% confidence interval [CI], 1.0-1.31), 1.11 (95% CI, 0.91-1.34), and 1.14 (95% CI, 0.94-1.38), respectively. Temporal trends in PCCRC risk did not differ by endoscopist specialty or institutional setting after covariate adjustment. Conclusion The PCCRC rate in Ontario has remained consistently high over time. Widespread initiatives are needed to improve colonoscopy quality.

BACKGROUND: Existing guidelines on colorectal cancer (CRC) screening for individuals with a family history (FH) of CRC or adenoma have not been based on systematic reviews or comprehensive assessment of the quality (=trustworthiness) of evidence (QoE). AIMS: To systematically review the literature to inform the ongoing development of a Canadian Association of Gastroenterology-supported Canadian and US guideline on CRC screening for individuals with FH of nonhereditary CRC or adenoma. METHODS: Multiple parallel systematic review streams, informed by a series of 10 literature searches, gathered evidence on 4 principal questions around the 1) effect of FH of CRC (or adenoma) on an individual’s risk of CRC, 2) age at which screening should begin, 3) recommended screening tests, and 4) recommended testing intervals for individuals with FH of CRC or adenoma. The GRADE approach was used to assess the QoE. RESULTS: The relative risk (RR) of CRC among individuals with FH of 1 first-degree relative (FDR) with CRC was estimated to be approximately 2-fold greater than among those without. The RR increased with an increasing number of FDRs with CRC. A FH of only second-degree relatives was associated with no or minimally elevated risk. The risk of CRC was increased by FH of advanced adenoma, but not with FH of a non-advanced adenoma. The age-specific risk of CRC fell on a continuum: RR increased with decreasing age of affected FDR, and increasing age of the screened individual, but RR was elevated at all ages compared to those with no FH. All the above were of very low QoE. Using data on efficacy (QoE ranging from very low to high), patient preference (very low QoE), and cost-effectiveness (very low QoE), colonoscopy and FIT ranked highest among screening test for individuals with FH of a FDR with CRC. Data on the optimal interval for CRC screening were limited (very low QoE), but suggested a potential benefit of shorter intervals for some individuals with FH compared to those at average risk. CONCLUSIONS: A FH of CRC or advanced adenoma is associated with a clinically important increased risk of CRC, which falls on an age continuum. FUNDING AGENCIES: Canadian Partnership Against Cancer (CPAC)

BACKGROUND: A sizeable number of individuals who participate in population-based colorectal cancer (CRC) screening programs and have a positive fecal occult blood test (FOBT) do not have an identifiable lesion found at colonoscopy to account for their positive FOBT screen.OBJECTIVE: To evaluate the evidence and provide recommendations regarding the use of routine esophagogastroduodenoscopy (EGD) to detect upper gastrointestinal (UGI) cancers in patients participating in a population-based CRC screening program who are FOBT positive and colonoscopy negative.METHODS: A systematic review was used to develop the evidentiary base and to inform the evidence-based recommendations provided.RESULTS: Nine studies identified a group of patients who were FOBT positive and colonoscopy negative. Three studies found no cases of UGI cancer. Four studies reported cases of UGI cancer; three found UGI cancer in 1% or less of the population studied, and one study found one case of UGI cancer that represented 7% of their small subgroup of FOBT-positive/colonoscopy-negative patients. Two studies did not provide outcome information that could be specifically related to the FOBT-positive/colonoscopy-negative subgroup.CONCLUSION: The current body of evidence is insufficient to recommend for or against routine EGD as a means of detecting gastric or esophageal cancers for patients who are FOBT positive/colonoscopy negative, in a population-based CRC screening program. The decision to perform EGD should be individualized and based on clinical judgement.

The current study sought to determine whether health status and health risk behaviors of Canadian women varied based on sexual identity. This was a cross-sectional analysis of data from the Canadian Community Health Survey: cycle 2.1, a national population-based survey designed to gather health data on a representative sample of over 135,000 Canadians including 354 lesbian respondents, 424 bisexual women respondents, and 60,937 heterosexual women respondents. Sexual orientation was associated with disparities in health status and health risk behaviors for lesbian and bisexual women in Canada. Bisexual women were more likely than lesbians or heterosexual women to report poor or fair mental and physical health, mood or anxiety disorders, lifetime STD diagnosis, and, most markedly, life-time suicidality. Lesbians and bisexual women were also more likely to report daily smoking and risky drinking than heterosexual women. In sum, sexual orientation was associated with health status in Canada. Bisexual women, in particular, reported poorer health outcomes than lesbian or heterosexual women, indicating this group may be an appropriate target for specific health promotion interventions.

Background The use of propofol to sedate patients for colonoscopy, generally administered by an anesthesiologist in North America, is increasingly popular. In the United States, regional use of anesthesiologist-assisted endoscopy appears to correlate with local payor policy. This study's objective was to identify nonpayor factors (patient, physician, institution) associated with anesthesiologist assistance at colonoscopy. Methods The authors performed a population-based cross-sectional analysis using Ontario health administrative data, 1993-2005. All outpatient colonoscopies performed on adults were identified. Hierarchical multivariable modeling was used to identify patient (age, sex, income quintile, comorbidity), physician (specialty, colonoscopy volume), and institution (type, volume) factors associated with receipt of anesthesiologist-assisted colonoscopy. Results During the study period, 1,838,879 colonoscopies were performed on 1,202,548 patients. The proportion of anesthesiologist-assisted colonoscopies rose from 8.4% in 1993 to 19.1% in 2005 (P < 0.0001). In the hierarchical model, patients in low-volume community hospitals were five times more likely to receive anesthesiologist-assisted colonoscopy than patients in high-volume community hospitals (odds ration 4.9; 95% confidence interval 4.4-5.5). Less than 1% of colonoscopies in academic hospitals were anesthesiologist-assisted. Compared to gastroenterologists, surgeons were more likely to perform anesthesiologist-associated colonoscopy (odds ratio 1.7; 95% confidence interval 1.1-2.6). Conclusions In Ontario, rates of anesthesiologist-assisted colonoscopy have risen dramatically. Institution type was most strongly associated with this practice. Further investigation is needed to determine the most appropriate criteria for the use of anesthesiology services during colonoscopy.

To assess the usage, knowledge and attitudes of Patients Living with HIV with respect to supplements. A questionnaire was mailed to people living with HIV via HIV/AIDS organizations in Ontario and distributed to those attending the HIV-clinic of the University Health Network. The survey was completed by 312 subjects (95 female, 207 male). Self-rated health status was considered fair/good in 77.5% and excellent in 15.4% of participants. Vitamin/mineral supplement was used by 75.6%. Main reasons to take supplements were to: prolong life (56.1%); treat HIV-related conditions (19.9%); increase energy level (42.6%) and to boost immunity (36.5%). Among participants, 54.2% were somewhat familiar with supplements, 44.7% trusted the information on the labels and 28.2% felt that if a supplement is available for sale, it is safe. Supplements were mostly purchased at pharmacies (45.5%) and health food stores (30.1%). Only 25.9% and 27.9% of participants discussed their use of supplements with their HIV or family doctor respectively. Supplements are frequently used by people living with HIV without consulting their doctors. Current research has not shown a clear benefit from micronutrient supplementation and with the possible potential drug interactions, people living with HIV will need nutrition education regarding supplement usage and should report their use to their physicians.

Objective The oncogenic HPV subtypes responsible for gynecologic malignancies have also been implicated in the development of squamous cell cancer of the anus (SCAC). SCAC is more common in women, typically presenting at an older age than gynecologic cancers. The aim of this study was determine whether women diagnosed with anal cancer are more likely to have a history of HPV-related gynecological cancer as compared to a matched control group. Methods We performed a population-based, case-control study at the Institute for Clinical Evaluative Sciences (ICES) which houses the administrative databases for all residents of the province of Ontario, Canada. All women diagnosed with SCAC between 1992 and 2005, identified using ICD-9 codes (154.2, 154.3, 154.8) for anatomic site and ICD-O codes (8070–8075, 8120, 8123, 8124) for histologic subtype, were included as cases. Up to 5 female controls, matched for age, socioeconomic status, health region and number of years enrolled in the provincial health plan, were selected for each case. The exposure of interest was previous HPV-related gynecologic cancer, specifically cervical cancer, vulvar cancer and vaginal cancer. Conditional logistic regression was performed to assess the relationship between this exposure and SCAC. Results A total of 674 women with SCAC were identified whose median age was 61. Amongst the cases, there were 7 cervical, 3 vulvar and 1 vaginal cancers compared with 5 cervical, 0 vulvar and vaginal cancers in the 3264 controls. Previous HPV-related gynecological cancer (cervical, vaginal or vulvar cancer) was significantly associated with SCAC (OR: 10.5, 95% C.I.: 3.6 to 30.3). The median time between the diagnosis of anal cancer and previous cervical cancer was 20 years. Conclusions Previous HPV-related gynecological cancers are strongly associated with anal cancer and may occur decades before the anal cancer.

Background: HIV-positive men with a history of anal-receptive intercourse are at risk for anal cancer. We determined whether human papilloma virus (HPV) biomarkers were correlated with anal pathology in these men.Methods: HPV genotype was determined by PCR/line blot assay. Real-time PCR assays were done for viral load, E6 transcripts for HPV genotypes 16, 18, and 31, and p16 transcripts.Results: The most common oncogenic HPV types were HPV 16 (38%), 18 (19%), 45 (22%), and 52 (19%). HPV types 16, 18, 31, 52, 59, and 68 were associated with high-grade histology. The number of HPV genotypes per anal swab was higher for anal intraepithelial neoplasia (AIN) 2/3 than for normal or AIN 1 histology [median, 5 types (interquartile range) (IQR), 3-7 versus 3.5 (IQR), 2-6; P = 0.0005]. HPV 16 viral load was also associated with AIN 2/3 histology. There was no difference in p16 or E6 transcripts between histologic grades. In the multivariable logistic regression model, HPV genotypes 16 [odds ratio, 2.58; 95% confidence interval (95% CI), 1.31-5.08; P = 0.006] and 31 (odds ratio, 4.74; 95% CI, 2.00-11.22; P = 0.0004), baseline CD4 count < 400 cells/mm3 (odds ratio, 2.96; 95% CI, 1.46-5.99; P = 0.0025), and Acquired Immunodeficiency Syndrome (AIDS)-defining illness (odds ratio, 2.42; 95% CI, 1.22-4.82; P = 0.01) were associated with high-grade histology after adjusting for age.Conclusions: The presence of high-grade anal pathology (AIN 2/3) in HIV-positive men was associated with multiple HPV genotypes, HPV genotypes 16 and 31, and HPV 16 viral load. (Cancer Epidemiol Biomarkers Prev 2009;18(7):1986–92)

Background: Inflammatory bowel disease (IBD) patients may be at increased risk for having no health insurance. Our objectives were to assess the prevalence of hospitalized IBD patients without insurance in the US and to characterize predictive factors. Methods: We identified IBD admissions in the Nationwide Inpatient Sample (1999-2005) and a 1% sample of general medical patients. We used population estimates from the US Census Bureau to calculate hospitalization rates, and logistic regression to determine predictors of being uninsured. Results: Although uninsured IBD patients were less likely to be hospitalized than those privately insured (incidence rate ratio [IRR] 0.41; 95% confidence interval [CI]: 0.38–0.45), their hospitalization rate increased from 8.3/100,000 to 12.5/100,000 (P < 0.001) over 7 years, outpacing private admissions. The proportion of uninsured IBD inpatients increased from 4.6% to 6.5% (P < 0.001), and IBD patients were more likely than general medical patients to be uninsured (5.1% vs. 4.1%, P < 0.0001). Predictors of being uninsured were being 21 to 40 years (odds ratio [OR] 1.95; 95% CI: 1.64–2.31), African American (OR 1.51; 95% CI: 1.29–0.76) or Hispanic (OR 2.21; 95% CI: 1.79–2.74), or residing in the southern US (OR 1.63; 95% CI: 1.27–2.11). Being female (OR 0.65; 95% CI: 0.61–0.70), residing in higher income neighborhoods (OR 0.69; 95% CI: 0.62–0.77), and higher comorbidity were protective factors. Conclusions: The rate of uninsured IBD admissions has risen disproportionately relative to the privately insured and general medical populations. We need measures to alleviate the burden of being uninsured among young and otherwise healthy adults with IBD who are most vulnerable. (Inflamm Bowel Dis 2008)

In the highly active antiretroviral therapy (HAART) era, HIV-related diarrhea remains common. Our aim was to evaluate stool frequency and form as measures of HIV-related diarrhea.Forty-eight HIV-infected persons with self-reported diarrhea were studied. In Analysis 1, self-reported retrospective and 7-day prospective measurement of stool frequency and form were compared using Spearman's correlation coefficient. In Analysis 2, diarrhea was measured during two 8-hour study periods in a subgroup (n = 20) using stool weight (Wt), diarrhea symptom score (Sx Score), stool frequency (SP-freq), and stool form using the Bristol Stool Form Scale (SP-BSFS). SP-freq and SP-BSFS were modeled alone and in combination to predict Wt and Sx Score.In Analysis 1, correlation between measures of stool frequency was rs = 0.62 (p.0001) but was rs = 0.16 (p = .26) between measures of stool form. In Analysis 2, the two-predictor model best predicted Wt, whereas the model using SP-freq only performed as well as the two-predictor model to predict Sx Score.Prospective measurement of stool frequency performed well; in some situations, it may be used alone to measure severity of HIV-related diarrhea. Our findings may be used to design more rigorous clinical trials in HIV.

Although colorectal cancer (CRC) is a common cause of cancer-related death, it is fortunately amenable to screening with faecal tests for occult blood and endoscopic tests. Despite the evidence for the efficacy of guaiac-based faecal occult blood tests (gFOBT), they have not been popular with primary care providers in many jurisdictions, in part because of poor sensitivity for advanced colorectal neoplasms (advanced adenomas and CRC). In order to address this issue, high sensitivity gFOBT have been recommended, however, these tests are limited by a reduction in specificity compared with the traditional gFOBT. Where colonoscopy is available, some providers have opted to recommend screening colonoscopy to their patients instead of faecal testing, as they believe it to be a better test. Newer methods for detecting occult human blood in faeces have been developed. These tests, called faecal immunochemical tests (FIT), are immunoassays specific for human haemoglobin. FIT hold considerable promise over the traditional guaiac methods including improved analytical and clinical sensitivity for CRC, better detection of advanced adenomas, and greater screenee participation. In addition, the quantitative FIT are more flexible than gFOBT as a numerical result is reported, allowing customisation of the positivity threshold. When compared with endoscopy, FIT are less sensitive for the detection of advanced colorectal neoplasms when only one time testing is applied to a screening population; however, this is offset by improved participation in a programme of annual or biennial screens and a better safety profile. This review will describe how gFOBT and FIT work and will present the evidence that supports the use of FIT over gFOBT, including the cost-effectiveness of FIT relative to gFOBT. Finally, specific issues related to FIT implementation will be discussed, particularly with respect to organised CRC screening programmes.

Background: Prior randomized, controlled trials (RCTs) indicate that patient navigation can boost colorectal cancer screening rates in primary care. The sparse literature on pragmatic trials of interventions designed to increase colorectal cancer screening adherence motivated this trial on the impact of a patient navigation intervention that included support for performance of the participants' preferred screening test (colonoscopy or stool blood testing). Materials and Methods: Primary care patients (n = 5,240), 50 to 74 years of age, with no prior diagnosis of bowel cancer and no record of a recent colorectal cancer screening test, were identified at the Group Health Centre in northern Ontario. These patients were randomly assigned to an intervention group (n = 2,629) or a usual care control group (n = 2,611). Intervention group participants were contacted by a trained nurse navigator by telephone to discuss colorectal cancer screening. Interested patients met with the navigator, who helped them identify and arrange for performance of the preferred screening test. Control group participants received usual care. Multivariate analyses were conducted using medical records data to assess intervention impact on screening adherence within 12 months after randomization. Results: Mean patient age was 59 years, and 50% of participants were women. Colorectal cancer screening adherence was higher in the intervention group (35%) than in the control group (20%), a difference that was statistically significant (OR, 2.11; confidence interval, 1.87–2.39). Conclusion: Preference-based patient navigation increased screening uptake in a pragmatic RCT. Impact: Patient navigation increased colorectal cancer screening rates in a pragmatic RCT in proportions similar to those observed in explanatory RCTs. Cancer Epidemiol Biomarkers Prev; 24(3); 506–11. ©2014 AACR.

BACKGROUND Anal carcinoma incidence is increasing, and is highest among men with human immunodeficiency virus (HIV) infection who have sex with men. Anal carcinoma and anal intraepithelial neoplasia (AIN) are ascertained on tissue histology, but requires invasive procedures. Screening for AIN using anal cytology was suggested. The authors evaluated agreement on cytologic and biopsy specimens from HIV-positive men undergoing anal carcinoma screening. METHODS One hundred twenty-nine HIV-positive men with a history of anal-receptive intercourse underwent anal cytology, anoscopy, and biopsy. Four pathologists independently assessed cytology and biopsy specimens and reached consensus for discordant cases. RESULTS Each pathologist evaluated 120 cytology and 155 biopsy specimens. The weighted kappa value for overall agreement was 0.54 (95% confidence interval [CI], 0.49–0.59) for cytology specimens and 0.59 (95%CI, 0.55–0.63) for biopsy specimens. The median kappa values for pairwise agreement among pathologists and for agreement with consensus were, respectively, 0.69 and 0.77 for cytology and 0.66 and 0.75 for biopsy. At least 3 pathologists were in agreement for 92 (76.7%) cytology and 134 (86.5%) biopsy specimens. Reliability for the Bethesda classification system was at least moderate, except for the cytologic category of atypical squamous cells of undetermined significance (kappa = 0.12). Fourteen of 29 (48.3%) cytology specimens and 36 of 47 (76.6%) biopsy specimens with consensus interpretation of high-grade squamous intraepithelial lesions (HSIL) were interpreted originally as HSIL by ≥ 3 pathologists. The kappa value for agreement with consensus distinguishing HSIL from non-HSIL ranged from 0.55 to 0.88 for cytology specimens and from 0.76 to 0.94 for biopsy specimens. CONCLUSIONS Agreement for cytologic and biopsy interpretations was generally at least moderate. Nevertheless, these results supported the need for disease indicators with greater reliabililty. Cancer 2005. © 2005 American Cancer Society.

Traditionally, randomized controlled trials (RCTs) have attempted to show the superiority of one intervention over another. However, when effective treatment already exists, it is sometimes more useful to prove that an intervention is equivalent, or at least not inferior, to the standard of care. Our aim was to determine whether claims of equivalency in digestive diseases trials are supported by the evidence.Medline was searched for RCTs published between 1989 and 2002 using the MeSH headings "exp therapeutic equivalency" and "exp digestive diseases" and the text words "equivalence," "equal," "equals," or "equivalent," yielding 902 articles. Of these, 73 articles met the inclusion criteria. These articles were evaluated using previously published criteria for equivalency.Of the included articles, 33% stated an a priori research aim of equivalency, 92% reported differences of20% between "equal" interventions, 34% set an equivalency boundary and tested it appropriately, and 19% performed a sample size calculation for equivalency. Overall, 12% of the reviewed articles met all 5 criteria. Fifty-two percent of our sample inappropriately used a failed superiority test (i.e., a P value0.05) as statistical "proof" of equivalency. Nonsurgical trials and those published between 1996 and 2002 were more likely to meet criteria than were surgical trials (P = 0.07) or trials published before 1996 (P = 0.003).Claims of equivalency between interventions in digestive diseases trials tend to be poorly supported by the evidence. Erroneous claims of equivalency are potentially dangerous and may lead to substandard patient care.

Background/Aims: Primary biliary cirrhosis (PBC) is an autoimmune disease characterized by inflammatory destruction of small bile ducts. Primary sclerosing cholangitis (PSC) is a different, presumed autoimmune cholestatic liver disease where the bile ducts are also destroyed. In this study, apoptosis and portal triad inflammation in liver tissue from patients with PBC is examined and compared to that from patients with PSC and patients with normal liver. Methods: Explanted liver tissue from patients with PBC and PSC and normal liver from patients with metastases to liver were examined. The liver samples were stained for apoptosis using the terminal deoxynucleotidyl triphosphate (TdT)-mediated deoxyuridine triphosphate nick end labelling (TUNEL) assay. The biliary epithelial cells (BEC) were then scored on the basis of their TUNEL stain and the degree of periductal inflammation. Results: In PBC, apoptosis of BEC, as detected by the TUNEL assay, was significantly increased in the presence of inflammation. Regardless of the presence or absence of inflammation, the small bile ducts in PBC liver tissue exhibited greater evidence of apoptosis than did similar ducts from PSC or control livers. Conclusion: These findings suggest that in PBC, unlike PSC, the apoptosis of BEC in PBC is secondary to the invasion of inflammatory cells.