Publications by authors named "Nicole Mittmann"

131 Publications

Evaluating the Indirect Costs of Care Associated with Salvage Chemotherapy for Relapsed and Refractory Aggressive-Histology Lymphoma: A Subset Analysis of the Canadian Cancer Trials Group (CCTG) LY.12 Clinical Trial.

Curr Oncol 2021 Mar 17;28(2):1256-1261. Epub 2021 Mar 17.

Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.

We conducted an analysis of indirect costs alongside the LY.12 randomized trial in patients with relapsed or refractory (R/R) aggressive non-Hodgkin lymphoma (NHL). Lost productivity data for Canadian patients and caregivers in the trial were collected at baseline and with each chemotherapy cycle pre-transplant, using an adapted Lost Productivity questionnaire. Mean per patient indirect costs were CAD 2999 for patients in the GDP arm and CAD 3400 in the DHAP arm. A substantial majority was not working or had to reduce their workload during this treatment time. Salvage chemotherapy for R/R aggressive NHL is associated with significant indirect costs to patients and their caregivers.
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http://dx.doi.org/10.3390/curroncol28020119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025821PMC
March 2021

A Canadian Prospective Study of Linkage of Randomized Clinical Trial to Cancer and Mortality Registry Data.

Curr Oncol 2021 03 8;28(2):1153-1160. Epub 2021 Mar 8.

Canadian Cancer Trials Group, Queen's University, Kingston, ON K7L 3N6, Canada.

In a prospective study, we sought to determine acceptability of linkage of administrative and clinical trial data among Canadian patients and Research Ethics Boards (REBs). The goal is to develop a more harmonized approach to data, with potential to improve clinical trial conduct through enhanced data quality collected at reduced cost and inconvenience for patients. On completion of the original LY.12 randomized clinical trial in lymphoma (NCT00078949), participants were invited to enrol in the Long-term Innovative Follow-up Extension (LIFE) component. Those consenting to do so provided comprehensive identifying information to facilitate linkage with their administrative data. We prospectively designed a global assessment of this innovative approach to clinical trial follow-up including rates of REB approval and patient consent. The pre-specified benchmark for patient acceptability was 80%. Of 16 REBs who reviewed the research protocol, 14 (89%) provided approval; two in Quebec declined due to small patient numbers. Of 140 patients invited to participate, 115 (82%, 95% CI 76 to 88%) from across 9 Canadian provinces provided consent and their full name, date of birth, health insurance number and postal code to facilitate linkage with their administrative data for long-term follow-up. Linkage of clinical trial and administrative data is feasible and acceptable. Further collaborative work including many stakeholders is required to develop an optimized secure approach to research. A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.
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http://dx.doi.org/10.3390/curroncol28020111DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025743PMC
March 2021

Influence of electronic triage decision-support on hospital admission, left without being seen and time to physician initial assessment in the emergency department.

CJEM 2021 Mar 8;23(2):214-218. Epub 2021 Jan 8.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.

Objective: To explore the impact of the implementation of eCTAS, a real-time electronic decision-support tool, on hospital admission, rate of left without being seen, and time from triage to physician initial assessment.

Methods: We conducted a cohort study using population-based administrative data from all Ontario emergency departments (EDs) that had implemented eCTAS for 9 months. We compared 6 months post-eCTAS data to the same 6 months the previous year (pre-eCTAS). We included triage encounters of adult (≥ 18 years) patients if they had one of 16 pre-specified, high-volume presenting complaints. Multivariable logistic regression and quantile regression models informed the effect of eCTAS on outcomes.

Results: We included data from 354,176 triage encounters from 31 EDs. There was a change in the distribution of triage scores post-eCTAS, with fewer patients classified as CTAS 2 and CTAS 3, and more patients classified as CTAS 1 and CTAS 4. Overall, hospital admission decreased post-eCTAS (adjusted OR: 0.98; 95% CI: 0.97 to 1.00), with fewer CTAS 2 and more CTAS 3 and CTAS 4 patients admitted post-eCTAS. The rate of left without being seen increased (2.8% vs. 3.0%; adjusted OR: 1.07; 95% CI: 1.03 to 1.11) post-eCTAS, while time to physician initial assessment proved similar pre and post-eCTAS.

Conclusions: eCTAS implementation had little impact on admission, rate of left without being seen and time to physician initial assessment. eCTAS appears to reclassify patients from higher to lower acuity scores, resulting in higher admission rates for CTAS 3 and CTAS 4 patients. It remains unknown if this reclassification is appropriate.
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http://dx.doi.org/10.1007/s43678-020-00043-1DOI Listing
March 2021

The cost of chemotherapy administration: a systematic review and meta-analysis.

Eur J Health Econ 2021 Mar 9. Epub 2021 Mar 9.

Division of General Surgery, Odette Cancer Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Ave., Room T2 011, Toronto, ON, M4N 3M5, Canada.

Purpose: Cancer treatment is a significant driver of healthcare costs worldwide, however, the economic impact of treating patients with anti-neoplastic agents is poorly elucidated. We conducted a systematic review and meta-analysis to estimate the direct costs associated with administering intravenous chemotherapy in an outpatient setting.

Methods: We systematically searched four databases from 2010 to present and extracted hourly administration costs and the respective components of each estimate. Separate analyses were conducted of Canadian and United States (US) studies, respectively, to address a priori hypotheses regarding heterogeneity amongst estimates. The Drummond checklist was used to assess risk-of-bias. Data were summarized using medians with interquartile ranges and five outliers were identified; costs were presented in 2019 USD.

Results: Forty-four studies were analyzed, including sub-analyses of 19 US and seven Canadian studies. 26/44 studies were of moderate-high quality. When components of administration cost were evaluated, physician costs were reported most frequently (24 studies), followed by lab tests (13) and overhead costs (9). The median estimate (excluding outliers) was $142/hour (IQR = $103-166). The median administration cost in the US was $149/hour (IQR = $118-158), and was $128/hour (IQR = $102-137) in Canada.

Conclusions: There is currently a paucity of literature addressing the costs of chemotherapy administration, and existing studies utilize a patchwork of reporting methodologies which renders direct comparison challenging. Our results demonstrate that the cost of administering chemotherapy is approximately $125-150/hour, globally. This value is dependent upon the region of analysis, inclusiveness of cost subcomponents as well as the methodology used to estimate unit prices, as described here.
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http://dx.doi.org/10.1007/s10198-021-01278-0DOI Listing
March 2021

Consistency of triage scores by presenting complaint pre- and post-implementation of a real-time electronic triage decision support tool.

J Am Coll Emerg Physicians Open 2020 Oct 21;1(5):747-756. Epub 2020 Apr 21.

Department of Health Research Methods, Evidence and Impact McMaster University Hamilton Ontario Canada.

Objective: eCTAS is a real-time electronic decision-support tool designed to standardize the application of the Canadian Triage and Acuity Scale (CTAS). This study addresses the variability of CTAS score distributions across institutions pre- and post-eCTAS implementation.

Methods: We used population-based administrative data from 2016-2018 from all emergency departments (EDs) that had implemented eCTAS for 9 months. Following a 3-month stabilization period, we compared 6 months post-eCTAS data to the same 6 months the previous year (pre-eCTAS). We included triage encounters of adult (≥17 years) patients who presented with 1 of 16 pre-specified, high-volume complaints. For each ED, consistency was calculated as the absolute difference in CTAS distribution compared to the average of all included EDs for each presenting complaint. Pre-eCTAS and post-eCTAS change scores were compared using a paired-samples . We also assessed if eCTAS modifiers were associated with triage consistency.

Results: There were 363,214 (183,231 pre-eCTAS, 179,983 post-eCTAS) triage encounters included from 35 EDs. Triage scores were more consistent ( < 0.05) post-eCTAS for 6 (37.5%) presenting complaints: chest pain (cardiac features), extremity weakness/symptoms of cerebrovascular accident, fever, shortness of breath, syncope, and hyperglycemia. Triage consistency was similar pre- and post-eCTAS for altered level of consciousness, anxiety/situational crisis, confusion, depression/suicidal/deliberate self-harm, general weakness, head injury, palpitations, seizure, substance misuse/intoxication, and vertigo. Use of eCTAS modifiers was associated with increased triage consistency.

Conclusions: eCTAS increased triage consistency across many, but not all, high-volume presenting complaints. Modifier use was associated with increased triage consistency, particularly for non-specific complaints such as fever and general weakness.
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http://dx.doi.org/10.1002/emp2.12062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7593433PMC
October 2020

Real-world, population-based cohort study of toxicity and resource utilization of second-line ipilimumab for metastatic melanoma in Ontario, Canada.

Int J Cancer 2021 Apr 7;148(8):1910-1918. Epub 2020 Nov 7.

Provincial Drug Reimbursement Program, Ontario Health (Cancer Care Ontario), Toronto, Ontario, Canada.

Second-line ipilimumab has been publicly funded in Ontario for metastatic melanoma (MM) since September 2012. We examined real-world toxicity of second-line ipilimumab compared to standard second-line treatments prior to funding. MM patients who received systemic treatment from April 2005 to March 2015 were included. Patients receiving second-line ipilimumab after September 2012 were considered as cases, and those who received second-line treatment prior to the funding date were included as historical controls. Outcomes assessed include treatment-related mortality, any-cause hospital visits, ipilimumab-related hospital visits and specialist visits (eg, endocrinologists, ophthalmologists, gastroenterologists, rheumatologists and respirologists), which were captured from up to 30 and/or 90 days after end of second-line treatment. Inverse probability of treatment weighting was used to adjust for baseline differences between groups. Odds ratios (ORs) from logistic regressions and rate ratios (RRs) from rate regressions were used to assess differences between groups. We identified 329 MM patients who received second-line treatments (ipilimumab: 189; controls: 140). Ipilimumab was associated greater any-cause (60.1% vs 45.7%; OR = 1.81; P value = .019) and ipilimumab-related (47.2% vs 31.9%; OR = 1.91; P value = .011) hospital visits. Adjusting for different follow-up days, ipilimumab was associated with higher rates of all-cause (RR = 1.56 [95%CI: 1.12-2.16]), and ipilimumab-related (RR = 2.18 [95% CI: 1.45-3.27]) hospital visits. Patients receiving ipilimumab were more likely to visit specialist involved in immunotherapy toxicity management (23.5% vs 13.7%; P value = .04). Compared to historical second-line treatments, second-line ipilimumab was associated with more health service utilization (specifically hospital visits and specialist visits), suggestive of potentially increased toxicity in the real world.
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http://dx.doi.org/10.1002/ijc.33357DOI Listing
April 2021

The Cost of Patient Education Materials Development: Opportunities to Identify Value and Priorities.

J Cancer Educ 2020 Oct 10. Epub 2020 Oct 10.

Ontario Health (Cancer Care Ontario), Toronto, Ontario, Canada.

The study aim was to evaluate the costs associated with developing and reviewing patient education materials (pamphlets) across Ontario cancer centers. While patient education often produces a positive return on investment, limited efforts have been dedicated to optimizing the personnel, time, and capital dedicated to this feat across healthcare systems. Patient education leaders at 14 cancer centers completed a survey measure, estimating the number of hours spent developing and reviewing pamphlets and identifying the personnel involved in each procedural step. The time expended per center in each step was then combined with average salary data for the identified personnel to derive total cost estimates. Cancer centers spend on average $5672 (SD = $3180) developing (M = $4560, SD = $2620) and reviewing (M = $1112, SD = $654) one pamphlet. This cumulates to an average per annum spending of $65,401 (SD = $75,494) for pamphlet development and $19,819 (SD = $28,524) for annual pamphlet review at each cancer center. The cost and number of hours spent developing and reviewing pamphlets varied substantially between cancer centers. While the security of budgets for patient education varies across cancer centers, opportunities to optimize human capital and monetary resources should be considered. Results of the study can be used to advocate for sustainable investment into cancer education programs, improve the coordination of educational materials production and review, and ensure that resource quality and access are consistent across the province.
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http://dx.doi.org/10.1007/s13187-020-01893-0DOI Listing
October 2020

Real-World Costs of Azacitidine Treatment in Patients With Higher-Risk Myelodysplastic Syndromes/Low Blast-Count Acute Myeloid Leukemia.

JCO Oncol Pract 2021 Apr 21;17(4):e517-e525. Epub 2020 Sep 21.

Division of Hematology/Medical Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

Purpose: Azacitidine (AZA) is a standard of care for higher-risk myelodysplastic syndrome (MDS)/low blast-count acute myeloid leukemia (AML). Despite this, there is a paucity of data on the real-world health care resource utilization costs of AZA in this population.

Methods: We linked the Ontario AZA MDS registry-higher-risk MDS/low blast-count AML-to population-based health system administrative databases. Patients were observed for 24 months after first AZA and censored at the earliest of 90 days after last AZA, date of death, time of AML induction/stem-cell transplantation, or March 31, 2016. Costs (2015 Canadian dollars) were expressed as standardized mean and median 28-day costs. Univariable quantile regression was used to explore the association of baseline patient and disease characteristics and median cost. Multivariable quantile regression was used to explore predictors of median costs.

Results: Among 877 patients in the registry, mean standardized 28-day cost per patient was $17,638 (median, $15,272; interquartile range [IQR], $11,869-$19,580) and $13,450 (median, $11,043; IQR, $7,981-$14,882) excluding the cost of AZA. Major nondrug drivers of cost were cancer clinic visits and inpatient care (mean standardized 28-day cost, $4,631; median, $1,558; IQR, $238-$4,961). Transfusion dependence at AZA initiation ( = .001) and greater comorbid disease burden ( = .009) were independently associated with increased cost.

Conclusion: Our cohort of patients with uniformly higher-risk MDS/low blast-count AML treated with AZA demonstrates substantial costs of care above and beyond the cost of AZA alone. These results provide insight into the costs of AZA in the real world with implications for resource allocation.
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http://dx.doi.org/10.1200/OP.20.00446DOI Listing
April 2021

The impact of routine Edmonton Symptom Assessment System (ESAS) use on overall survival in cancer patients: Results of a population-based retrospective matched cohort analysis.

Cancer Med 2020 10 14;9(19):7107-7115. Epub 2020 Aug 14.

Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.

Background: The Edmonton Symptom Assessment System (ESAS) is a validated instrument whose use has been standardized in the Ontario cancer system to measure symptoms among ambulatory cancer patients. The objective was to examine the effect of ESAS exposure on overall survival. We hypothesized, a priori, that patients exposed to ESAS would have higher rates of overall survival than those who were not exposed.

Methods: This was a retrospective matched cohort study of adults diagnosed with cancer between 2007 and 2015. Patients were considered exposed if they were screened with ESAS at least once during the study period. Their first ESAS screening date defined the index date. Each exposed patient was matched randomly to a cancer patient without ESAS using a combination of hard matching (4 variables) and propensity score matching (14 variables). Kaplan-Meier curves and multivariable Cox regression were used to evaluate the impact of ESAS exposure on survival.

Results: There were 128,893 pairs well matched on all baseline characteristics. The probability of survival within the first 5 years was higher among those exposed to ESAS compared to those who were not (81.9% vs. 76.4% at 1 year, 68.3% vs. 66.1% at 3 years, 61.9% vs. 61.4% at 5 years, P-value < .0001). In the multivariable Cox regression model, ESAS was significantly associated with a decreased mortality risk (HR: 0.48, 95% CI: 0.47-0.49).

Conclusions: Our results show that ESAS exposure is associated with improved survival in cancer patients. This provides real world evidence of the impact of routine symptom assessment in cancer care.
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http://dx.doi.org/10.1002/cam4.3374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7541161PMC
October 2020

The Movember Prostate Cancer Landscape Analysis: an assessment of unmet research needs.

Nat Rev Urol 2020 Sep 22;17(9):499-512. Epub 2020 Jul 22.

Movember, Melbourne, Victoria, Australia.

Prostate cancer is a heterogeneous cancer with widely varying levels of morbidity and mortality. Approaches to prostate cancer screening, diagnosis, surveillance, treatment and management differ around the world. To identify the highest priority research needs across the prostate cancer biomedical research domain, Movember conducted a landscape analysis with the aim of maximizing the effect of future research investment through global collaborative efforts and partnerships. A global Landscape Analysis Committee (LAC) was established to act as an independent group of experts across urology, medical oncology, radiation oncology, radiology, pathology, translational research, health economics and patient advocacy. Men with prostate cancer and thought leaders from a variety of disciplines provided a range of key insights through a range of interviews. Insights were prioritized against predetermined criteria to understand the areas of greatest unmet need. From these efforts, 17 research needs in prostate cancer were agreed on and prioritized, and 3 received the maximum prioritization score by the LAC: first, to establish more sensitive and specific tests to improve disease screening and diagnosis; second, to develop indicators to better stratify low-risk prostate cancer for determining which men should go on active surveillance; and third, to integrate companion diagnostics into randomized clinical trials to enable prediction of treatment response. On the basis of the findings from the landscape analysis, Movember will now have an increased focus on addressing the specific research needs that have been identified, with particular investment in research efforts that reduce disease progression and lead to improved therapies for advanced prostate cancer.
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http://dx.doi.org/10.1038/s41585-020-0349-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462750PMC
September 2020

Rapid review methods more challenging during COVID-19: commentary with a focus on 8 knowledge synthesis steps.

J Clin Epidemiol 2020 10 29;126:177-183. Epub 2020 Jun 29.

Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, 209 Victoria Street, East Building, Toronto, Ontario M5B 1T8, Canada; Department of Geriatric Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S 1A1, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2020.06.029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836683PMC
October 2020

Impact of Standardized Edmonton Symptom Assessment System Use on Emergency Department Visits and Hospitalization: Results of a Population-Based Retrospective Matched Cohort Analysis.

JCO Oncol Pract 2020 09 28;16(9):e958-e965. Epub 2020 May 28.

Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.

Purpose: The Edmonton Symptom Assessment System (ESAS) is a validated instrument whose use has been standardized in the Ontario cancer system to measure symptoms among ambulatory patients with cancer. The objective was to examine the effect of ESAS exposure on visits to the emergency department (ED) and hospitalizations.

Methods: This was a retrospective matched cohort study conducted in Ontario, Canada. The study included patients ≥ 18 years of age diagnosed with cancer between 2007 and 2015. Patients were considered exposed if they were screened with ESAS at least once during the study period, and their first ESAS screening date was defined as the index date. Each exposed patient was matched randomly to a patient with cancer without ESAS assessment using a combination of hard matching (birth year ± 2 years, cancer diagnosis date ± 1 year, cancer type, and sex) and propensity score matching (14 variables, including cancer stage, treatments received, and comorbidities). A multivariable Andersen-Gill recurrent event model was used to evaluate the effect of ESAS on the rate of health care use.

Results: The analysis included 128,893 matched pairs that were well balanced on baseline measures. After adjusting for other variables, patients with ESAS had lower rates of both ED visits (relative rate [RR], 0.92; 95% CI, 0.91 to 0.93) and hospitalizations (RR, 0.86; 95% CI, 0.85 to 0.87) compared with patients without ESAS.

Conclusion: ESAS exposure is independently associated with decreased rates of ED visits and hospitalizations. This provides real-world evidence of one potential positive impact of standardized symptom assessment in cancer care.
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http://dx.doi.org/10.1200/JOP.19.00660DOI Listing
September 2020

Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada.

BMC Cancer 2020 Apr 15;20(1):304. Epub 2020 Apr 15.

Cancer Care Ontario, Toronto, ON, Canada.

Background: For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment's real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments).

Methods: We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW).

Results: We identified 329 patients with metastatic melanoma (MM) who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27-41%), 20.6% (15-27%), and 15.2% (9.6-21%) for ipilimumab and 17.1% (11-23%), 7.1% (2.9-11%), and 4.7% (1.2-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR = 0.62; 95% CI: 0.49-0.78; p < 0.0001).

Conclusions: This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.
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http://dx.doi.org/10.1186/s12885-020-06798-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158109PMC
April 2020

Assessing the Impact of Early Identification of Patients Appropriate for Palliative Care on Resource Use and Costs in the Final Month of Life.

JCO Oncol Pract 2020 08 20;16(8):e688-e702. Epub 2020 Mar 20.

Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Purpose: This study evaluates whether an intervention to identify Canadian patients eligible for a palliative approach changes the use of health care resources and costs within the final month of life.

Methods: Between 2014 and 2017, physicians identified 1,187 patients in family practice units and cancer centers who were likely to die within 1 year based on diagnosis, symptom assessment, and performance status. A multidisciplinary intervention that included activation of community resources and initiation of palliative planning was started. By using propensity-score matching, patients in the intervention group were matched 1:1 with nonintervention controls selected from provincial administrative data. We compared health care use and costs (using 2017 Canadian dollars) for 30 days before death between patients who died within the 1-year follow-up and matched controls.

Results: Groups (n = 629 in each group) were well-balanced in sociodemographic characteristics, comorbidities, and previous health care use. In the last 30 days, there was no differences in proportions between the two groups of patients regarding emergency department visits, intensive care unit admissions, or inpatient hospitalizations. However, patients in the intervention group had greater use of palliative physician encounters, community home care visits, and/or physician home visits (92.8% 88.4%; = .007). In the 507 pairs with cancer, more patients in the intervention group underwent chemotherapy (44% 33%; < .001) and radiation (18.7% 3.2%; = .043) in the last 30 days. Mean cost per patient was similar for the intervention group (mean, $17,231; 95% CI, $16,027 to $18,436) and for the control group (mean, $16,951; 95% CI, $15,899 to $18,004).

Conclusion: Even with the limitations in our observational study design, identification of palliative patients did not significantly change overall costs but may shift resources toward palliative services.
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http://dx.doi.org/10.1200/JOP.19.00397DOI Listing
August 2020

Health system costs for cancer medications and radiation treatment in Ontario for the 4 most common cancers: a retrospective cohort study.

CMAJ Open 2020 Jan-Mar;8(1):E191-E198. Epub 2020 Mar 16.

Sunnybrook Research Institute (Mittmann, Seung) and Odette Cancer Centre (Look Hong, Earle, Cheung, Coburn, DeAngelis), Sunnybrook Health Sciences Centre; Cancer Care Ontario (Mittmann), Toronto, Ont.; Canadian Agency for Drugs and Technologies in Health (Mittmann), Ottawa, Ont.; ICES (Liu, Cheng, Saxena, Earle, Cheung, Coburn); Health Outcomes and PharmacoEconomic (HOPE) Research Centre (Seung); University Health Network (Leighl), Toronto, Ont.; McMaster University (Evans), Hamilton, Ont.

Background: Previous costing and resource estimates for cancer have not been complete owing to lack of comprehensive data on cancer-related medication and radiation treatment. Our objective was to calculate the mean overall costs per patient of cancer-related medications and radiation, as well as by disease subtype and stage, in the first year after diagnosis for the 4 most prevalent cancers in Ontario.

Methods: We conducted a retrospective cohort study using provincial health administrative databases to identify population health system resources and costs for all patients diagnosed with breast, colorectal, lung or prostate cancer between Jan. 1, 2010, and Dec. 31, 2015 in Ontario. The primary outcome measure was the overall average cost per patient in the 365 days after diagnosis for cancer-related medications and radiation treatment, calculated with the use of 2 novel costing algorithms. We determined the cost by disease, disease subtype and stage as secondary outcomes.

Results: There were 168 316 Ontarians diagnosed with cancer during the study period, 50 141 with breast cancer, 38 108 with colorectal cancer, 34 809 with lung cancer and 45 258 with prostate cancer. The mean per-patient cost for cancer-related medications was $8167 (95% confidence interval [CI] $8023-$8311), $6568 (95% CI $6446-$6691), $2900 (95% CI $2816-$2984) and $1211 (95% CI $1175-$1247) for breast, colorectal, lung and prostate cancer, respectively. The corresponding mean radiation treatment costs were $18 529 (95% CI $18 415-$18 643), $15 177 (95% CI $14 899-$15 456), $10 818 (95% CI $10 669-$10 966) and $16 887 (95% CI $16 648-$17 125). In general, stage III and IV cancers were the most expensive stages for both medications and radiation across all 4 disease sites.

Interpretation: Our work updates previous costing estimates to help understand costs and resources critical to health care system planning in a single-payer system. More refined costing estimates are useful as inputs to allow for more robust health economic modelling and health care system planning.
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http://dx.doi.org/10.9778/cmajo.20190114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7082106PMC
February 2021

Healthcare utilization in patients with higher-risk MDS/low-blast count AML treated with azacitidine in the 'real-world'.

Leuk Lymphoma 2020 06 8;61(6):1445-1454. Epub 2020 Feb 8.

Division of Hematology/Medical Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.

Despite the adoption of azacitidine (AZA) in higher-risk MDS/low-blast count AML, limited 'real-world' data on resource utilization and toxicity exist. We linked the Ontario AZA-MDS registry to population-based administrative databases. Among 877 patients in the registry, 705 (80.4%) had at least one emergency department (ED) visit, 290 (33.1%) had an ED visit during their first cycle and 680 patients (77.5%) had at least one hospitalization (mean length 17.7 days, 95% CI 16.3-19.1). Older age, rurality, non-response to AZA, transfusion dependence, IPSS score, and greater comorbidity were independent predictors of increased ED visits; while greater comorbidity, non-response to AZA, and transfusion dependence were associated with longer hospitalization. When restricted to receiving ≥3 cycles, hospitalization during the first cycle was associated with increased risk of death. Our analysis of 'real-world' patients treated with AZA demonstrates significant healthcare utilization and increased risk of death for patients hospitalized during their first cycle. These results will inform patients/providers about 'real-world' toxicities of AZA.
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http://dx.doi.org/10.1080/10428194.2020.1723012DOI Listing
June 2020

Does early palliative identification improve the use of palliative care services?

PLoS One 2020 31;15(1):e0226597. Epub 2020 Jan 31.

Odette Cancer Centre, Toronto, Ontario, Canada.

Purpose: To evaluate whether the early identification of patients who may benefit from palliative care impacts on the use of palliative, community and acute-based care services.

Methods: Between 2014 and 2017, physicians from eight sites were encouraged to systematically identify patients who were likely to die within one year and would were thought to benefit from early palliative care. Patients in the INTEGRATE Intervention Group were 1:1 matched to controls selected from provincial healthcare administrative data using propensity score-matching. The use of palliative care, community-based care services (home care, physician home visit, and outpatient opioid use) and acute care (emergency department, hospitalization) was each evaluated within one year after the date of identification. The hazard ratio (HR) in the Intervention Group was calculated for each outcome.

Results: Of the 1,185 patients in the Intervention Group, 951 (80.3%) used palliative care services during follow-up, compared to 739 (62.4%) among 1,185 patients in the Control Group [HR of 1.69 (95% CI 1.56 to 1.82)]. The Intervention Group also had higher proportions of patients who used home care [81.4% vs. 55.2%; HR 2.07 (95% CI 1.89 to 2.27)], had physician home visits [35.5% vs. 23.7%; HR 1.63 (95% CI 1.46 to 1.92)] or had increased outpatient opioid use [64.3% vs. 52.1%); HR 1.43 (95% CI 1.30 to 1.57]. The Intervention Group was also more likely to have a hospitalization that was not primarily focused on palliative care (1.42 (95% CI 1.28 to 1.58)) and an unplanned emergency department visit for non-palliative care purpose (1.47 (95% CI 1.32 to 1.64)).

Conclusion: Physicians actively identifying patients who would benefit from palliative care resulted in increased use of palliative and community-based care services, but also increased use of acute care services.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226597PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6994244PMC
April 2020

Evaluating the Tolerability of a Simultaneous Focal Boost to the Gross Tumor in Prostate SABR: A Toxicity and Quality-of-Life Comparison of Two Prospective Trials.

Int J Radiat Oncol Biol Phys 2020 05 25;107(1):136-142. Epub 2020 Jan 25.

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. Electronic address:

Purpose: Dose-escalated stereotactic ablative radiotherapy (SABR) to the whole prostate may be associated with better outcomes but has a risk of increased toxicity. An alternative approach is to focally boost the dominant intraprostatic lesion (DIL) seen on magnetic resonance imaging. We report the toxicity and quality-of-life (QOL) outcomes of 2 phase 2 trials of prostate and pelvic SABR, with or without a simultaneous DIL boost.

Methods And Materials: The first trial treated patients with high-risk prostate cancer to a dose of 40 Gy to the prostate and 25 Gy to the pelvis in 5 fractions. The second trial treated patients with intermediate-risk and high-risk prostate cancer to a dose of 35 Gy to the prostate, 25 Gy to the pelvis, and a DIL boost up to 50 Gy in 5 fractions. Acute toxicities, late toxicities, and QOL were assessed.

Results: Thirty patients were enrolled in each trial. In the focal boost cohort, the median DIL D90% was 48.3 Gy. There was no significant difference in acute grade ≥2 gastrointestinal or genitourinary toxicity between the 2 trials or in cumulative worst late gastrointestinal or genitourinary toxicity up to 24 months. There was no significant difference in QOL domain scores or minimally clinical important change between the 2 trials.

Conclusions: Prostate and pelvic SABR with a simultaneous DIL boost was feasible. Acute grade ≥2 toxicity, late toxicity, and QOL seemed to be comparable to a cohort that did not receive a focal boost. Further follow-up will be required to assess long-term outcomes, and randomized data are required to confirm these findings.
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http://dx.doi.org/10.1016/j.ijrobp.2019.12.044DOI Listing
May 2020

High-Cost Patients and Preventable Spending: A Population-Based Study.

J Natl Compr Canc Netw 2020 01;18(1):23-31

Cancer Care Ontario, Toronto, Ontario, Canada.

Background: Although high-cost (HC) patients make up a small proportion of patients, they account for most health system costs. However, little is known about HC patients with cancer or whether some of their care could potentially be prevented. This analysis sought to characterize HC patients with cancer and quantify the costs of preventable acute care (emergency department visits and inpatient hospitalizations).

Methods: This analysis examined a population-based sample of all HC patients in Ontario in 2013. HC patients were defined as those above the 90th percentile of the cost distribution; all other patients were defined as non-high-cost (NHC). Patients with cancer were identified through the Ontario Cancer Registry. Sociodemographic and clinical characteristics were examined and the costs of preventable acute care for both groups by category of visit/condition were estimated using validated algorithms.

Results: Compared with NHC patients with cancer (n=369,422), HC patients with cancer (n=187,770) were older (mean age 70 vs 65 years), more likely to live in low-income neighborhoods (19% vs 16%), sicker, and more likely to live in long-term care homes (8% vs 0%). Although most patients from both cohorts tended to be diagnosed with breast, prostate, or colorectal cancer, those with multiple myeloma or pancreatic or liver cancers were overrepresented among the HC group. Moreover, HC patients were more likely to have advanced cancer at diagnosis and be in the initial or terminal phase of treatment compared with NHC patients. Among HC patients with cancer, 9% of spending stemmed from potentially preventable/avoidable acute care, whereas for NHC patients, this spending was approximately 30%.

Conclusions: HC patients with cancer are a unique subpopulation. Given the type of care they receive, there seems to be limited scope to prevent acute care spending among this patient group. To reduce costs, other strategies, such as making hospital care more efficient and generating less costly encounters involving chemotherapy, should be explored.
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http://dx.doi.org/10.6004/jnccn.2019.7342DOI Listing
January 2020

The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.

Phys Ther 2020 04;100(4):662-676

Department of Kinesiology, University of Waterloo; and Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada; and KITE, Toronto Rehab-University Health Network, Toronto, Ontario, Canada.

Background: Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures.

Objective: This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures.

Design: This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups.

Setting: This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers.

Participants: This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures.

Intervention: A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention.

Measurements: Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses.

Results: There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = -1.58 [95% CI = -3.09 to -0.07], intention-to-treat; MD = -1.49 [95% CI = -3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time.

Limitations: Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses.

Conclusions: Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.
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http://dx.doi.org/10.1093/ptj/pzz188DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7439228PMC
April 2020

Economic impacts of care by high-volume providers for non-curative esophagogastric cancer: a population-based analysis.

Gastric Cancer 2020 05 13;23(3):373-381. Epub 2019 Dec 13.

Division of General Surgery, Odette Cancer Centre, Sunnybrook Health Sciences Centre, 2075, Bayview Avenue, T2-063, Toronto, ON, M4N 3M5, Canada.

Background: Esophagogastric cancer (EGC) is one of the deadliest and costliest malignancies to treat. Care by high-volume providers can provide better outcomes for patients with EGC. Cost implications of volume-based cancer care are unclear. We examined the cost-effectiveness of care by high-volume medical oncology providers for non-curative management of EGC.

Methods: We conducted a population-based cohort study of non-curative EGC over 2005-2017 by linking administrative datasets. High-volume was defined as ≥ 11 patients/provider/year. Healthcare costs ($USD/patient/month-survived) were computed from diagnosis to death or end of follow-up from the perspective of the healthcare system. Multivariable quantile regression examined the association between care by high-volume providers and costs. Sensitivity analyses were conducted by varying costing horizons and high-volume definitions.

Results: Among 7011 non-curative EGC patients, median overall survival was superior with care by high-volume providers with 7.0 (IQR 3.3-13.3) compared to 5.9 (IQR 2.6-12.1) months (p < 0.001) for low-volume providers. Median costs/patient/month-lived were lower for high-volume providers ($5518 vs. $5911; p < 0.001), owing to lower inpatient acute care costs, despite higher medication-associated and radiotherapy costs. Care by high-volume providers was independently associated with a reduction of $599 per patient/month-lived (95% confidence interval - 966 to - 331) compared to low-volume providers. The incremental cost-effectiveness ratio was - 393. Care by high-volume providers remained the dominant strategy when varying the costing horizon and the high-volume definition.

Conclusion: Care by high-volume providers for non-curative EGC is associated with superior survival and lower healthcare costs, indicating a dominant strategy that may provide an opportunity to improve cost-effectiveness of care delivery.
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http://dx.doi.org/10.1007/s10120-019-01031-wDOI Listing
May 2020

Real-world outcomes of FOLFIRINOX vs gemcitabine and nab-paclitaxel in advanced pancreatic cancer: A population-based propensity score-weighted analysis.

Cancer Med 2020 01 13;9(1):160-169. Epub 2019 Nov 13.

Cancer Care Ontario, Toronto, ON, Canada.

Background: In Ontario, FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GnP) have been publicly funded for first-line unresectable locally advanced pancreatic cancer (uLAPC) or metastatic pancreatic cancer (mPC) since April 2015. We examined the real-world effectiveness and safety of FFX vs GnP for advanced pancreatic cancer, and in uLAPC and mPC.

Methods: Patients receiving first-line FFX or GnP from April 2015 to March 2017 were identified in the New Drug Funding Program database. Baseline characteristics and outcomes were obtained through the Ontario Cancer Registry and other population-based databases. Overall survival (OS) was assessed using Kaplan-Meier and weighted Cox proportional hazard models, weighted by the inverse propensity score adjusting for baseline characteristics. Weighted odds ratio (OR) for hospitalization and emergency department visits (EDV) were estimated from weighted logistic regression models.

Results: For 1130 patients (632 FFX, 498 GnP), crude median OS was 9.6 and 6.1 months for FFX and GnP, respectively. Weighted OS was improved for FFX vs GnP (HR = 0.77, 0.70-0.85). Less frequent EDV and hospitalization were observed in FFX (EDV: 67.8%; Hospitalization: 49.2%) than GnP (EDV: 77.7%; Hospitalization: 59.3%). More frequent febrile neutropenia-related hospitalization was observed in FFX (5.8%) than GnP (3.3%). Risk of EDV and hospitalization were significantly lower for FFX vs GnP (EDV: OR = 0.68, P = .0001; Hospitalization: OR = 0.76, P = .002), whereas the risk of febrile neutropenia-related hospitalization was significantly higher (OR = 2.12, P = .001). Outcomes for uLAPC and mPC were similar.

Conclusion: In the real world, FFX had longer OS, less frequent all-cause EDV and all-cause hospitalization, but more febrile neutropenia-related hospitalization compared to GnP.
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http://dx.doi.org/10.1002/cam4.2705DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943167PMC
January 2020

Interrater Reliability, Accuracy, and Triage Time Pre- and Post-implementation of a Real-Time Electronic Triage Decision-Support Tool.

Ann Emerg Med 2020 04 26;75(4):524-531. Epub 2019 Sep 26.

Schwartz/Reisman Emergency Medicine Institute, Sinai Health System, Toronto, Ontario, Canada; Department of Family and Community Medicine, Division of Emergency Medicine, University of Toronto, Toronto, Ontario, Canada.

Study Objective: The electronic Canadian Triage and Acuity Scale (eCTAS) is a real-time electronic triage decision-support tool designed to improve patient safety and quality of care by standardizing the application of the Canadian Triage and Acuity Scale (CTAS). The objective of this study is to determine interrater agreement of triage scores pre- and post-implementation of eCTAS.

Methods: This was a prospective, observational study conducted in 7 emergency departments (EDs), selected to represent a mix of triage documentation practices, hospital types, and patient volumes. A provincial CTAS auditor observed triage nurses in the ED pre- and post-implementation of eCTAS and assigned an independent CTAS score in real time. Research assistants independently recorded triage time. Interrater agreement was estimated with κ statistics with 95% confidence intervals (CIs).

Results: A total of 1,491 individual triage assessments (752 pre-eCTAS, 739 post-implementation) were audited during 42 7-hour triage shifts (21 pre-eCTAS, 21 post-implementation). Exact modal agreement was achieved for 567 patients (75.4%) pre-eCTAS compared with 685 patients (92.7%) triaged with eCTAS. With the auditor's CTAS score as the reference, eCTAS significantly reduced the number of patients over-triaged (12.0% versus 5.1%; Δ 6.9; 95% CI 4.0 to 9.7) and under-triaged (12.6% versus 2.2%; Δ 10.4; 95% CI 7.9 to 13.2). Interrater agreement was higher with eCTAS (unweighted κ 0.89 versus 0.63; quadratic-weighted κ 0.93 versus 0.79). Median triage time was 312 seconds (n=3,808 patients) pre-eCTAS and 347 seconds (n=3,489 patients) with eCTAS (Δ 35 seconds; 95% CI 29 to 40 seconds).

Conclusion: A standardized, electronic approach to performing triage assessments improves both interrater agreement and data accuracy without substantially increasing triage time.
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http://dx.doi.org/10.1016/j.annemergmed.2019.07.048DOI Listing
April 2020

Economic Analysis of Adjuvant Chemoradiotherapy Compared with Chemotherapy in Resected Pancreas Cancer.

Ann Surg Oncol 2019 Dec 18;26(13):4193-4203. Epub 2019 Sep 18.

Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.

Background: Population-based survival and costs of pancreas adenocarcinoma patients receiving adjuvant chemoradiation and chemotherapy following pancreaticoduodenectomy are poorly understood.

Methods: This retrospective cohort study used linked administrative and pathological datasets to identify all patients diagnosed with pancreas adenocarcinoma and undergoing pancreaticoduodenectomy in Ontario between April 2004 and March 2014, who received postoperative chemoradiation or chemotherapy. Stage and margin status were defined by using pathology reports. Kaplan-Meier and Cox proportional hazards regression survival analyses were used to determine associations between adjuvant treatment approach and survival, while stratifying by margin status. Median overall health system costs were calculated at 1 and 3 years for chemoradiation and chemotherapy, and differences were tested using the Kruskal-Wallis test.

Results: Among 709 patients undergoing pancreaticoduodenectomy for pancreas cancer during the study period, the median survival was 21 months. Median survival was 19 months for chemoradiation and 22 months for chemotherapy. Patients receiving chemoradiation were more likely to have positive margins: 47.7% compared with 19.2% in chemotherapy. After stratifying by margin status and controlling for confounders, adjusted hazard ratio of death were not statistically different between chemotherapy and chemoradiation [margin positive, hazard ratio (HR) = 0.99, 95% confidence interval (CI) = 0.88-1.27; margin negative, HR 0.95, 95% CI 0.91-1.18]. Overall 1-year health system costs were significantly higher for chemoradiation (USD $70,047) than chemotherapy (USD $54,005) (p ≤ 0.001).

Conclusions: Chemotherapy and chemoradiation yielded similar survival, but chemoradiation resulted in higher costs. To create more sustainable healthcare systems, both the efficacy and costs of therapies should be considered.
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http://dx.doi.org/10.1245/s10434-019-07808-8DOI Listing
December 2019

Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol.

BMC Cancer 2019 Sep 5;19(1):884. Epub 2019 Sep 5.

Ontario Institute for Cancer Research, Toronto, ON, Canada.

Background: Population-based studies suggest that emergency department visits and hospitalizations are common among patients receiving chemotherapy and that rates in routine practice are higher than expected from clinical trials. Chemotherapy-related toxicities are often predictable and, consequently, acute care visits may be preventable with adequate treatment planning and support between visits to the cancer centre. We will evaluate the impact of proactive telephone-based toxicity management on emergency department visits and hospitalizations in women with early stage breast cancer receiving chemotherapy.

Methods: In this pragmatic covariate constraint-based cluster randomized trial, 20 centres in Ontario, Canada are randomly allocated to either proactive telephone toxicity management (intervention) or routine care (control). The primary outcome is the cluster-level mean number of ED + H visits per patient evaluated using Ontario administrative healthcare data. Participants are all patients with early stage (I-III) breast cancer commencing adjuvant or neo-adjuvant chemotherapy at participating institutions during the intervention period. At least 25 patients at each centre participate in a patient reported outcomes sub-study involving the collection of standardized questionnaires to measure: severity of treatment toxicities, self-care, self-efficacy, quality of life, and coordination of care. Patients participating in the patient reported outcomes (PRO) sub-study are asked to provide written consent to link their PRO data to administrative data. Unit costs will be applied to each per person resource utilized, and a total cost per population and patient will be generated. An incremental cost-effectiveness analysis will be undertaken to compare the incremental costs and outcomes between the intervention and control groups from the health system perspective.

Discussion: This study evaluates the effectiveness of a proactive toxicity management intervention in a routine care setting. The use of administrative healthcare data to evaluate the primary outcome enables an evaluation in a real world setting and at a much larger scale than previous studies.

Trial Registration: Clinicaltrials.gov , NCT02485678. Registered 30 June 2015.
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http://dx.doi.org/10.1186/s12885-019-6099-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6729066PMC
September 2019

Demographic characteristics and cost of treatment among oncology patients in a publicly funded system, the Ontario Trillium Drug Program: a retrospective cohort study.

CMAJ Open 2019 Jul-Sep;7(3):E516-E523. Epub 2019 Aug 20.

ICES (Cheng, Saxena, Earle); Sunnybrook Research Institute (Seung, Mittmann) and Odette Cancer Centre (Earle, Chan), Sunnybrook Health Sciences Centre; Departments of Medicine (Earle, Chan) and Pharmacology and Toxicology (Mittmann), University of Toronto; Canadian Centre for Applied Research in Cancer Control (Chan); Canadian Partnership Against Cancer (Earle), Toronto, Ont.

Background: The aim of this study was to characterize the demographic characteristics and investigate the cost of a publicly funded system, the Ontario Trillium Drug Program (TDP), for an oncology patient population.

Methods: We ascertained all TDP claims between April 1997 and December 2016 from the Ontario Drug Benefit database to assess use and cost. Each drug was classified as a cancer treatment drug, cancer supportive therapy drug or noncancer drug. We also identified a cohort of patients with cancer with least 1 TDP claim, for whom we examined demographic and claims-related characteristics.

Results: Over the study period, 50 975 293 TDP claims totalling $4.8 billion were made. Although the proportion of cancer claims among all TDP claims remained constant between 1997 and 2016, the total annual cost of cancer treatment drugs increased nearly 40-fold. Imatinib and lenalidomide together accounted for nearly half of the cost of all cancer treatment drugs. We identified a cohort of 49 892 patients with cancer, of whom 18 631 (37.3%) were enrolled in the TDP before their cancer diagnosis and 31 261 (62.7%) were enrolled after their diagnosis. The former were more likely than the latter to be in lower income quintiles and to have more chronic conditions. Significant differences were also found in the distribution of cancer diagnoses between the 2 groups.

Interpretation: In the TDP, use increased over time and differed across cancer diagnoses and drugs. These results have public health and policy implications as antineoplastic drug costs continue to rise and place a burden on patients.
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http://dx.doi.org/10.9778/cmajo.20190011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6703988PMC
August 2019

Acceptability of Routine Evaluations Using Patient-Reported Outcomes of Common Terminology Criteria for Adverse Events and Other Patient-Reported Symptom Outcome Tools in Cancer Outpatients: Princess Margaret Cancer Centre Experience.

Oncologist 2019 11 13;24(11):e1219-e1227. Epub 2019 Aug 13.

Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada

Background: Recent studies have demonstrated improved outcomes with real-time patient-reported outcome questionnaires (PRO questionnaires) using questions adapted for patient use from the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). Outside of the clinical trial setting, limited information exists on factors affecting the completion of PRO questionnaires in routine practice. The primary aim of this prospective cross-sectional study was to evaluate patient willingness to complete PRO questionnaires on a regular basis and to better understand responder biases to improve patient feedback.

Materials And Methods: Patients performing PRO-CTCAE toxicity and symptom PRO questionnaires in oncology clinics at Princess Margaret Cancer Centre from 2013 to 2016 were assessed for their willingness to complete PRO questionnaires using a nine-item, tablet-based acceptability survey. Patient-reported characteristics (i.e., age, sex, language, marital status, education, occupation, etc.), cancer type, treatment modalities, and health metrics (i.e., Eastern Cooperative Oncology Group) were also collected. Characteristics were evaluated by logistic regression (odds ratios [OR]) using the primary outcome with prespecified levels of significance for univariate ( ≤ .10), and additional multivariate ( ≤ .05) testing.

Results: A total of 1,792 patients (median age 60 years; range 18-97) with various cancer diagnoses were assessed. A greater proportion of female (56%) and white (74%) respondents with an annual household income of <$100,000 (69%) participated. More than half (58%) of respondents were willing to complete PRO questionnaires at every clinic visit, and a high proportion (77%) found utility in reporting physical and emotional feelings to clinicians using PRO questionnaires. In general, patients did not find that PRO questionnaires made clinic visits more difficult (93%). In uni- and multivariable testing, patients were more willing to complete sleep- and fatigue-related PRO questionnaires relative to chemotoxicity-based PRO questionnaires (OR 1.52; = .012). Patients aged 40-65 versus 18-40 years were also more likely to report high PRO questionnaire acceptability (OR 1.49; = .025). Additional patient characteristics such as white ethnicity (OR 1.76), Canada as country of birth (OR 1.66), and English language (OR 2.15) relative to other had higher acceptability on uni- ( < .001) and multivariable ( < .001) analyses. Patients reporting treatment intent as palliative (OR 0.69; = .0013) or hematological (OR 0.73; = .027) were less likely to report high PRO questionnaire acceptability on univariable analysis; however, only palliative patients (OR 0.72) maintained this effect on multivariable testing ( = .012). Patients reporting higher health utility scores (per change in .05) also had significantly increased PRO questionnaire acceptability in uni- (OR 1.06; < .001) and multivariable (OR 1.05; = .008) analyses. No significant differences in PRO questionnaire acceptability were seen between cancer types, education level, household income, employment status, or treatment modality.

Conclusion: Routine assessment using PRO questionnaires is associated with moderate acceptability by patients with cancer. Specific patient characteristics are associated with higher completion willingness. Additional research is necessary to identify factors associated with low acceptability of PRO questionnaires and to develop site-, ethnicity-, and treatment-specific instruments to assess the value of PRO questionnaires for symptom monitoring in clinical practice.

Implications For Practice: This study will help to identify the clinical, demographic, and survey characteristics associated with willingness to complete patient-reported outcome questionnaires regularly in the cancer outpatient setting.
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http://dx.doi.org/10.1634/theoncologist.2018-0830DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6853088PMC
November 2019

Can Administrative Data Improve the Performance of Cancer Clinical Trial Economic Analyses?

J Oncol Pract 2019 09 15;15(9):e807-e824. Epub 2019 Jul 15.

Canadian Cancer Trials Group, Kingston, Ontario, Canada.

Purpose: Trial economic analyses, such as cost-effectiveness analysis, often rely on trial-collected data, which are burdensome and expensive to collect and may be incomplete. In contrast, administrative databases systematically collect health system encounters. We investigated whether administrative data could improve the performance of cancer trial economic analysis.

Methods: Health administrative data were probabilistically linked to Ontario patient data from the Canadian Cancer Trials Group CO.17 trial (n = 572), which evaluated cetuximab plus best supportive care (75 linked Ontario patients) versus best supportive care alone (73 patients) in previously treated metastatic colorectal cancer. Trial-collected resource utilization data and vital status were compared with administrative data. Cost effectiveness in 2007 Canadian dollars was determined with bootstrap incremental cost-effectiveness ratio (ICER) CIs.

Results: Up to trial date of last contact, administrative data vital status was concordant in more than 96%. Twenty-nine subsequent deaths occurred. Up to trial last contact, there were 50 net additional hospitalizations in administrative data and 33 net additional emergency department visits. Total costs were $3,023,034 for the cetuximab group and $1,191,118 for the control group up to trial last contact. The ICER was $211,128 per life-year gained (90% CI, $101,396 to $694,950) up to trial last contact and $164,378 (90% CI, -$138,260 to $644,555) up to administrative data last contact. ICER estimates were similar to the analysis using trial-collected data.

Conclusion: Administrative data were more complete than trial data for hospital encounters, a key cost driver in economic analysis. There was a longer follow-up. This demonstrates the potential of administrative data to relieve the burden of collecting key data in cancer trials, which represents a considerable effort and expense.
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http://dx.doi.org/10.1200/JOP.18.00691DOI Listing
September 2019

Are osteoporotic vertebral fractures or forward head posture associated with performance-based measures of balance and mobility?

Arch Osteoporos 2019 06 26;14(1):67. Epub 2019 Jun 26.

Department of Kinesiology, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada.

The main objective of this study was to explore whether vertebral fracture characteristics or posture is independently associated with physical performance. Posture was significantly associated with physical performance but fracture characteristics were not, suggesting posture should be the focus of physical performance variance.

Purpose: The main objective of this study was to explore whether vertebral fracture characteristics (number, severity, location) or occiput-to-wall distance (OWD) is independently associated with physical performance.

Methods: This was a secondary data analysis using baseline data from a randomized controlled trial, of community-dwelling women aged 65 years and older with a suspected vertebral fragility fracture. Lateral thoracic and lumbar spine radiographs were used to determine the number, location, and severity of fracture. The dependent variables were timed up and go (TUG), five times sit-to-stand, four-meter walk, and step test. The independent variables were number, severity, location of fracture, and OWD. Pain during movement and age were covariates. Multivariable regression analyses determined the association between each of the dependent and independent variables.

Results: Participants' (n = 158) mean (standard deviation [SD]) age was 75.9 (6.5) years. They had a mean (SD) BMI, OWD, and number of fractures of 26.7 (5.3) kg/m, 5.7 (4.6) cm, and 2.2 (1.8), respectively. OWD was independently associated with TUG (estimated coefficient [B] = 0.29, 95% confidence interval [CI] = 0.16, 0.42), five times sit-to-stand (B = 0.33, 95% CI = 0.12, 0.55), four-meter walk (B = 0.09, 95% CI = 0.05, 0.13), and step test (B = - 0.36, 95% CI = - 0.50, - 0.23) in the unadjusted model. OWD was independently associated with TUG (B = 0.25, 95% CI = 0.12, 0.38), five times sit-to-stand (B = 0.29, 95% CI = 0.07, 0.50), four-meter walk (B = 0.08, 95% CI = 0.03, 0.12), and step test (B = - 0.22, 95% CI = - 0.47, - 0.19) in the adjusted model.

Conclusion: OWD was significantly associated with physical performance but fracture characteristics were not. These analyses were exploratory and require replication in future studies.
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http://dx.doi.org/10.1007/s11657-019-0626-xDOI Listing
June 2019

Impact of smoking on health system costs among cancer patients in a retrospective cohort study in Ontario, Canada.

BMJ Open 2019 06 21;9(6):e026022. Epub 2019 Jun 21.

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.

Objective: Smoking is the main modifiable cancer risk factor. The objective of this study was to examine the impact of smoking on health system costs among newly diagnosed adult patients with cancer. Specifically, costs of patients with cancer who were current smokers were compared with those of non-smokers from a publicly funded health system perspective.

Methods: This population-based cohort study of patients with cancer used administrative databases to identify smokers and non-smokers (1 April 2014-31 March 2016) and their healthcare costs in the 12-24 months following a cancer diagnosis. The health services included were hospitalisations, emergency room visits, drugs, home care services and physician services (from the time of diagnosis onwards). The difference in cost (ie, incremental cost) between patients with cancer who were smokers and those who were non-smokers was estimated using a generalised linear model (with log link and gamma distribution), and adjusted for age, sex, neighbourhood income, rurality, cancer site, cancer stage, geographical region and comorbidities.

Results: This study identified 3606 smokers and 14 911 non-smokers. Smokers were significantly younger (61 vs 65 years), more likely to be male (53%), lived in poorer neighbourhoods, had more advanced cancer stage,and were more likely to die within 1 year of diagnosis, compared with non-smokers. The regression model revealed that, on average, smokers had significantly higher monthly healthcare costs ($5091) than non-smokers ($4847), p<0.05.

Conclusions: Smoking status has a significant impact on healthcare costs among patients with cancer. On average, smokers incurred higher healthcare costs than non-smokers. These findings provide a further rationale for efforts to introduce evidence-based smoking cessation programmes as a standard of care for patients with cancer as they have the potential not only to improve patients' outcomes but also to reduce the economic burden of smoking on the healthcare system.
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http://dx.doi.org/10.1136/bmjopen-2018-026022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6596959PMC
June 2019