Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes.

BACKGROUND: Clinical trials are important but extremely costly. Utilization of routinely collected administrative data may simplify and enhance clinical trial data collection. PURPOSE: The aim of this study was to test the feasibility of use of administrative databases in Ontario, Canada, for long-term clinical trial follow-up, specifically (a) to determine whether limited patient identifiers held by the Canadian Cancer Trials Group can be used to probabilistically link with individuals in the Institute for Clinical Evaluative Sciences databases and if so, (b) the level of concordance between the two data sets. METHODS: This retrospective study was conducted through collaboration of established health service (Institute for Clinical Evaluative Sciences) and clinical trial (Canadian Cancer Trials Group) research groups in the province of Ontario, Canada, where healthcare is predominantly funded by the government. Adults with pre-treated metastatic colorectal cancer previously enrolled in the Canadian Cancer Trials Group CO.17 and CO.20 randomized phase III trials were included, limited to those in Ontario. The main outcomes were rate of successful probabilistic linkage and concordance of survival data, stated a priori. RESULTS: Probabilistic linkage was successful in 266/293 (90.8%) participants. In those patients for whom linkage was successful, the Canadian Cancer Trials Group (trial) and the Institute for Clinical Evaluative Sciences (administrative) data sets were concordant with regard to the occurrence of death during the period of clinical trial follow-up in 206/209 (98.6%). Death was recorded in the Institute for Clinical Evaluative Sciences, but not the Canadian Cancer Trials Group, for 57 cases, where the event occurred after the clinical trial cut-off dates. The recorded date of death matched closely between both databases. During the period of clinical trial conduct, administrative databases contained details of hospitalizations and emergency room visits not captured in the clinical trial electronic database. CONCLUSION: Prospective use of administrative data could enhance clinical trial data collection, both for long-term follow-up and resource utilization for economic analyses and do so less expensively than current primary data collection. Recording a unique identifier (e.g. health insurance number) in trial databases would allow deterministic linkage for all participants.

Decreased Colorectal Cancer Incidence and Incidence-Based Mortality in the Screening-Age Population of Ontario.

BACKGROUND AND AIMS: We aimed to evaluate trends in Ontario, Canada, 2002 to 2016, in uptake of colorectal evaluative procedures, colorectal cancer (CRC) incidence and incidence-based mortality in the colorectal screening-age population. METHODS: We defined the screening age-eligible population as persons 51 to 74 years of age with ≥1 year eligibility for the Ontario Health Insurance Plan, excluding those with a diagnosis of CRC in the Ontario Cancer Registry (OCR) prior to age 50 or January 1, 2002. We computed annual up-to-date status with colorectal evaluative procedures from billing claims, and CRC incidence from the OCR. In order to compute incidence-based CRC mortality, we included persons with a first diagnosis of CRC between the ages of 51 and 74, diagnosed between January 1, 1992 and December 31, 2001, still alive and <75 years of age on January 1, 2002, based on cause of death from the OCR. Overall, age-stratified and sex-stratified trends were evaluated by Cochran-Armitage trend tests. RESULTS: Persons up to date with colorectal evaluative procedures increased from 628,214/2,782,061 (22.6%) in 2002 to 2,584,570/4,179,789 (62.2%) in 2016. CRC incidence fell from 129.3/100,000 in 2002 to 94.54/100,000 in 2016, and incidence-based CRC mortality fell from 40.8/100,000 to 24.1/100,000. Decreasing trends in overall and stratified incidence and mortality were all significant, except among persons 51 to 54 years old. CONCLUSIONS: There was continued increase in persons up-to-date with colorectal evaluative procedures, and significant decrease in CRC incidence and incidence-based CRC mortality from 2002 through 2016.

Morbidity and mortality following major large bowel resection for colorectal cancer detected by a population-based screening program.

BACKGROUND AND AIMS: In 2008, Ontario initiated a population-based colorectal screening program using guaiac fecal occult blood testing. This work was undertaken to fill a major gap in knowledge by estimating serious post-operative complications and mortality following major large bowel resection of colorectal cancer detected by a population-based screening program. METHODS: We identified persons with a first positive fecal occult blood result between 2008 and 2016, at the age of 50-74 years, who underwent a colonoscopy within 6 months, and proceeded to major large bowel resection for colon cancer within 6 months or rectosigmoid/rectal cancer within 12 months, and identified an unscreened cohort of resected cases diagnosed during the same years at the age of 50-74 years. We identified serious postoperative complications and readmissions ≤30 days following resection, and postoperative mortality ≤30 days, and between 31 and 90 days among the screen-detected and the unscreened cohorts. RESULTS: Serious post-operative complications or readmissions within 30 days were observed among 1476/4999 (29.5%) cases in the screen-detected cohort, and among 3060/8848 (34.6%) unscreened cases. Mortality within 30 days was 43/4999 (0.9%) among the screen-detected cohort, and 208/8848 (2.4%) among the unscreened cohort. Among 30 day survivors, mortality between 31 and 90 days was 28/4956 (0.6%) and 111/8640 (1.3%), respectively. CONCLUSION: Serious post-operative complications, readmissions, and mortality may be more common following major large bowel resection for colorectal cancer between the ages of 50 and 74 among unscreened compared to screen-detected cases.

Factors Associated With Opioid Use in Long-term Cancer Survivors.

PURPOSE: To evaluate factors associated with opioid use in patients with cancer surviving more than five years without recurrence. We evaluated exposures of opioid use before cancer diagnosis, opioid use between cancer diagnosis and five-year anniversary, surgeries, and chemotherapy. METHODS: We conducted a retrospective cohort study using linked provincial administrative data. Patients were aged 24-70 years and eligible for government-funded pharmacare. The index date was the five-year anniversary from diagnosis. Patients were accrued between 2010 and 2015. The main outcome was opioid prescription rate after index date. The main exposures were opioid use before diagnosis, opioid use between diagnosis and index, surgeries, and chemotherapy. A negative binomial regression model was used to estimate relative rates (RR) of opioid use after index date. RESULTS: Our cohort included 7431 individuals. The overall crude prescription rate after the index date was 2 per person-year. The factor most strongly associated with a higher rate of opioid use after index was continuous opioid use between diagnosis and index (RR 46.1, 95% confidence interval 34.8-61.2). Opioid use before diagnosis was also a factor (RR = 1.8, 95% confidence interval 1.44-2.19). A history of depression, comorbidity, and more than two years of diabetes were also associated with higher risk of post-index date opioid use. Significant interactions were identified between prior opioid use and opioid use between diagnosis and index. Most prescriptions are from family physicians. CONCLUSION: Patients who use opioids continuously between diagnosis and index date are at increased risk of continued use after five years of survival. Safe and appropriate pain management is an important survivorship issue.