Studies In-Progress

Purpose

To estimate the prevalence chronic hepatitis C (CHC) and to determine the clinical-effectiveness, cost-effectiveness, and affordability of different HCV treatment prioritization strategies for all Canadian provinces.

Research Questions

1. What are the prevalence of CHC and the number of untreated individuals for each province in Canada?

2. What is the financial impact to the provincial formulary with the current restricted reimbursement scenario?

3. When is the best time and what is the best strategy to ease the reimbursement restricted criteria?

4. What will be the financial impact to the provincial formulary after easing reimbursement criteria?

5. When is the best time to phase in hepatitis C population screening in order to identify undiagnosed individuals?

6. What is the financial impact to the provincial formulary once hepatitis C population screening is in place?

Design and Methods

A five-step modeling project to estimate the prevalence, the number of untreated individuals, and to determine the clinical effectiveness, cost-effectiveness, and affordability of different hepatitis C virus (HCV) treatment prioritization strategies for all Canadian provinces, using data from cancer registries, administrative health care databases, expert committee discussions and literature reviews. The study will use a state-transition model to estimate the prevalence and an individual-level state transition model for cost-effectiveness analysis (CEA) of different screening and treatment prioritization strategies. For each strategy explored, the study will perform comprehensive budget impact analysis (BIA) for each province.

Step I – Expert Committee

Step II - Retrospective Cohort Study Utilizing Administrative Data

Step III - Estimate the prevalence using a backpropagation model

Step IV - Policy model for chronic hepatitis C (CHC) treatment prioritizing options

Step V - Comprehensive Budget Impact Analyses for Canadian Provinces

Progress

The back-calculation model has been set up and its implementation and calibration is in progress.

Study Timeline

November 2016 – October 2019

Research Team

Murray Krahn, MD, MSc, FRCPC
William Wong, PhD
Valeria Rac, MD, PhD
Abdullah Hamadeh, PhD
Alex Haines, MSc
Josephine Wong, MD

Funding

Canadian Liver Foundation Grant

Publications / Presentations

 

Purpose

To determine the burden of hepatitis C virus (HCV) by evaluating:

1. The impact of successful treatment with new direct-acting antiviral agents (DAAs) on health-related quality of life (HRQL) and utilities in chronic hepatitis C (CHC) patients;
2. HRQL and utilities in patients with late stage disease (hepatocellular carcinoma (HCC), compensated cirrhosis (CC) and decompensated cirrhosis (DC));
3. Productivity loss and out-of-pocket costs associated with HCV treatment with DAAs and outcomes

Research Questions

1. What is the impact of the new DAA treatment regimens on HRQL, utilities, and indirect costs?
2. What are the HRQL, utilities, and indirect costs in patients with late stage CHC (CC, HCC, and DC)?
3. What are the out-of-pocket costs, and time costs for time periods associated with CHC patients without cirrhosis or HCC; CHC patients with HCC; and CHC patients with compensated cirrhosis or decompensated cirrhosis?

Design and Methods

A three-year, pan-Canadian, multi-centre (Calgary, Montreal, and Toronto), two-component study using self-reported questionnaires:

Component 1: A longitudinal prospective study to evaluate the change in health-related quality of life (HRQL) and utilities with the new HCV treatment regimens.
Component 2: A cross-sectional study to assess HRQL and utilities in Chronic Hepatitis C (CHC) patients with late stage disease (hepatocellular carcinoma (HCC), compensated cirrhosis (CC) and decompensated cirrhosis (DC)).

Inclusion Criteria

Component 1 Cohort: A diagnosis of CHC and scheduled for treatment with a DAA, with or without prior treatment.
Component 2 Cohort: A diagnosis of CHC with HCC, or CHC with CC/DC.

Exclusion Criteria

• Unable or unwilling to provide informed consent
• Cognitive or mental health disorder impeding comprehension and completion of questionnaires
• Life expectancy of less than six months.

Progress

We have started recruitment at the University Health Network and at the Liver Unit of the University of Calgary.

Study Timeline

April 2017 – June 2019

Research Team

William Wong, PhD
Murray Krahn, MD, MSc, FRCPC
Julie Bruneau, MD, MSc
Jordan Feld, MD, MPH
Samuel Lee, MD
Jeff Powis, MD, FRCPC
Lusine Abrahamyan, PhD
Karen Bremner, BSc
Zeny Feng, PhD
Karen Lee, MA
Nicholas Mitsakakis, MSc, PhD
Petros Pechlivanoglou, PhD
Valeria Rac, MD, PhD
Beate Sander, PhD, MEcDev, MBA, RN
Bryna Warshawsky, MD, FRCPC
Kate Mason, MHSc
Arcturus Phoon
Yasmin Saeed, PhD (Candidate)
Josephine Wong, MD

Funding

CIHR Project Grant

Publications / Presentations

 

Purpose

Prostate cancer (PC) treatment is rapidly evolving with new modalities providing more personalized, effective, and increasingly costly options. Several new treatments for non-metastatic castrate-resistant prostate cancer (NM-CRPC), including immunotherapies, antiandrogens,  bone-targeted agents, and androgen-receptor targeted agents, have been tested or are currently being tested in clinical trials, all aiming to prolong metastasis-free survival. Although current Canadian and US guidelines do not recommend systemic chemotherapy or immunotherapy for NM-CRPC, patients are encouraged to participate in clinical trials.

Information regarding the current incidence, prevalence and cost of treatment of NM-CRPC and more advanced stages is currently lacking in Canada. This information is highly important for Canadian policymakers facing reimbursement decisions for new drug and non-drug health technologies. Therefore, more up-to-date and robust epidemiologic and economic data concerning NM-CRPC and advanced PC are needed to guide future research and policy decision-making

Study Design & Objectives

This is a three–project retrospective study to obtain comprehensive data on the epidemiology and health care costs of males with NM-CRPC using data from cancer registries, administrative health care databases, and PC clinics in two Canadian provinces, Ontario and Quebec. The study will also identify the pathways leading to NM-CRPC and estimate transition probabilities from previous health states and to subsequent ones. Our specific objectives are to:

• Obtain current prevalence, incidence and survival probability estimates of PC stratified by age, year of diagnosis, and stage of diagnosis (Project 1);
• Identify pathways leading to and factors associated with developing NM-CRPC using information from patient medical records at PC clinics (Project 2);
• Estimate annual incidence and prevalence of NM-CRPC, using administrative data (Project 3);
• Estimate stratified probability of developing NM-CRPC and transition probabilities that characterize the prognosis from NM-CRPC to metastasis and end-of-life (Projects 2 & 3);
• Estimate health care resource use and costs of PC recurrence from NM-CRPC to metastasis and death (Project 3).

Progress

Currently, projects 1 and 2 are underway.

Research Team

Murray Krahn, MD MSc FRCPC (Co-PI)
Antonio Finelli, MD MSc FRCPC (Co-PI)
Valeria Rac, MD, PhD (Investigator)
Lusine Abrahamyan, MD, PhD (Investigator)
William Wong, PhD (Investigator)
Alice Dragomir, PhD (Investigator)
Amen Aprikian, MD (Investigator)
Stuart Peacock, PhD (Investigator)
Shabbir Alibhai, MD MSc, FRCPC (Investigator)
Karen Bremner, BSc (Study Coordinator)
Steven Carcone, MSc (Research Associate)
Lisa Masucci, MSc PhD(c) (Collaborator)
Nicholas Mitsakakis, MSc, PhD (Biostatistician)

Funding 

Prostate Cancer Canada

Purpose

The purpose of this study is to conduct a multi-level evaluation of the Telehomecare intervention offered to patients diagnosed with Heart Failure (HF) or Chronic Obstructive Pulmonary Disease (COPD) across 8 local health integration networks (LHINs) in Ontario in comparison with the ‘usual care’.

Research Questions

Primary:

1. What is the impact of the Telehomecare on disease-specific hospitalization and ED visits in comparison with ‘usual care’ for COPD and HF patients followed up to 18 months?

Secondary:

2. What is the impact of the program on all-cause hospitalization/ ED visits and other uses of the healthcare system including primary care, specialists, long-term facility and medication use in comparison with ‘usual care’?
3. What are the costs associated with the program and its cost-effectiveness in comparison with the ‘usual care’?
4. What are the program’s patterns of use and the perceived impact on patient quality of life, self-management, satisfaction with care and informal caregiver strain?
5. What are the perceptions and experiences of program users (patients, informal caregivers, technicians, healthcare providers, administrators, decision-makers) as well as the overall adoption, integration and sustainability of the program?

Inclusion Criteria

Patient:

A patient that has:

• A documented diagnosis of HF or COPD (with or without co-morbid conditions)
• Classified as a ‘heavy user’ of the health care system, characterized by any of the following:
  • A minimum of one hospitalization for a respiratory or cardiac complaint in the past six months
  • A minimum of two emergency department/urgent care center visits for a respiratory or cardiac complaint in the past six months
  • Currently receiving nursing services via CCAC
  • Frequent visits to primary care provider in the past year
• Patient/informal caregiver (if applicable) is an adult (over 18 years), able and willing to provide informed consent
• Patient/informal caregiver (if applicable) is fluent in English
• Patient/informal caregiver is able and willing to operate the Telehomecare equipment
• Patient lives in a residential (private home or retirement home) setting with an active landline

In addition to the program eligibility criteria, the following criteria for the intervention evaluation study apply to the recruitment of patients:

• Patient must have a documented consent for participating in Telehomecare 
• Patients enrolled in the Telehomecare program must have agreed to share their contact and health information for evaluative purposes 
• Patients must provide informed consent before participating in observations, interviews and surveys as part of the program evaluation study

Healthcare Provider

A healthcare provider that has:

• Referred a patient that has been previously enrolled in the Telehomecare program, and/or
• Provided primary care to a patient enrolled in the evaluation study
• Previously or currently participated in delivering Telehomecare as a provider or care administrator
  • For observations, interviews and surveys: nurses/physicians must have at least 2 months experience in providing care using Telehomecare

Technicians, Administrators and/or Decision Makers

The following are eligible for inclusion in the study:

• Technicians involved in the set-up of Telehomecare equipment in the patient home.
• Administrators and/or decision makers of the Telehomecare program as a larger network of care such as Healthcare Program Managers, key members of the LHINs, OTN etc.

Exclusion Criteria

Patient

• Less than 18 years of age;
• Individuals without an established diagnosis of COPD or HF
• Unable or unwilling to provide verbal informed consent
• Demonstrated non-adherence to the THC program
  • The Telehomecare Nurse works with each patient on a case-by-case review to assess willingness to partner in their own care, and if the number of missed consultation appointments and reasons for demonstrate overall non-adherence with the program;
• Inability or unwillingness to use Telehomecare equipment, and/or;
• Do not have a regular caregiver to assist in the use of the equipment (if assistance is required)

Healthcare Provider

• Is not a practicing healthcare provider in any of the participating LHINs

Technicians, Administrators and/or Decision Makers

• Unable or unwilling to provide verbal informed consent

Design and Methods

The evaluation of the Telehomecare intervention is a mixed-methods study comprising of four components (sub-studies).

1. Comparative Effectiveness Study is a propensity matched cohort study that will evaluate patient clinical outcomes using administrative data (ICES) in comparison with the ‘usual care’. The main outcomes of interest focus on health services utilization (i.e. hospital admissions, ED visits, primary care visits).

2. Economic Evaluation Study consists of two sub-studies:

1. Descriptive Costing Study will evaluate costs associated with the Telehomecare and the ‘usual care’, including patient level clinical outcomes (e.g. hospitalization, ED visits) using administrative data (ICES).
2. Cost-effectiveness Matched Cohort Study will evaluate cost-effectiveness of the Telehomecare in comparison with the ‘usual care’.

3. Evaluation study of Telehomecare use consists of two sub-studies:

1. Quantitative Descriptive Study uses administrative data (PMMS database that contains patient information such as: medication use, blood pressure etc.) to comprehensively evaluate the program, its implementation, patterns of use and its efficacy.
2. Longitudinal Surveys Study will capture patients’and informal caregivers’ quality of life, disease management skills, as well as satisfaction with care. Surveys will be conducted over the phone.

4. Adoption Study – by conducting ethnographic observations, in-depth semi-structured interviews, documentation collection and review, this study will explore perceptions and experiences of program users (patients, informal caregivers, healthcare providers, technicians, administrators, and key decision makers) as well as the overall adoption, integration and sustainability of the program.

Study Timeline

The study duration is expected to take 2-3 years.

Research Team

Valeria Rac, MD, PhD (Principal Investigator)
Murray Krahn, MSc, MD (Co-Principal Investigator)
Lusine Abrahamyan, MD, MPH, PhD
Morgan Slater PhD
William Wong PhD
Michael Hillmer MSc, PhD
Heather Ross MHSc, MD, FRCPC
Petros Pechlivanoglou MSc, PhD
Nicholas Mitsakakis Msc, PhD
Nida Shahid, HBSc
Yeva Sahakyan, MD, MPH
Gemma Hunting HBHSc, MA
Farah Mawani Msc, PhD (Candidate)
Aleksandra Stanimirovic MPH, PhD (Candidate)
Yelena Petrosyan, MD, MPH, PhD(Candidate)
Welson Ryan

Funding

Ontario Ministry of Health and Long-Term Care

 

 

Purpose

The study aims to provide a comprehensive set of quality indicators (QIs) for evaluating the quality of OTN Telehomecare Program for patients with heart failure (HF) or chronic obstructive pulmonary disease (COPD).

Objectives

1. To conduct a systematic review to identify a set of QIs for evaluating OTN Telehomecare Program among patient with HF or COPD;
2. To develop a preliminary list of QIs targeting the following domains: patient/caregiver, clinical, technical, services provided to patients, economical, and organizational and social;
3. To critically appraise and select the final set of QIs using a Delphi panel.   

Design and Methods

Study 1 (Objectives 1&2): A systematic literature review will be conducted to identify all measures used to assess Telehomecare programs in patients with HF or COPD in the following databases: OVID Medline, EMBASE, Cochrane Library, AMED and CINAHL. In terms of types of studies, we will consider randomized controlled trials (RCT), observational, economic evaluation, and systematic review/meta-analysis studies.

Study selection criteria:

• Population: Patients with HF or COPD, or chronic diseases (if applicable);
• Intervention: home-based telehealth interventions using audio, or other information and communication technologies to provide patient remote monitoring and care at home, including health coaching sessions;
• Comparators: usual care.

Criteria used for data extraction and development of the preliminary list of candidate QIs:

• Solid scientific evidence derived from:
  • systematic reviews or multiple large RCTs;
  • well conducted observational research studies when evidence from RCTs is not available;
  • if neither RCT nor observational study evidence is available, published papers with expert panel consensus might be acceptable;
• Process/structure measures have established a linkage with health outcomes;
• Risk adjustment available for outcome measures.

Study 2 (Objective 3): Critical appraisal and selection of the final indicators using a Delphi panel: For the purpose of this project, we will carry a three-round Delphi procedure to rate and select QIs (separately for HF and COPD QIs). We will purposefully select a heterogeneous group of experts to better reflect the variety of stakeholders involved in the Telehomecare program. Healthcare provider and patient panels will be established (1:1 ratio) to ensure that differing views are represented in the final consensus.

Inclusion criteria for healthcare provider panel:

• Willingness to participate in the panel;
• Knowledge of the relevant topic;
• Absence of conflicts of interest;

Inclusion criteria for the patient panel:

• Having a diagnosis of HF or COPD;
• Willingness to participate in the panel;
• Successfully discharged from the Telehomecare program.

Rating of QIs

Healthcare providers will be asked to rate each candidate indicator against a set of five evaluation criteria, including importance, validity, reliability, feasibility, and overall value for inclusion, using a five-point Likert scale with the anchors form ‘strongly disagree’ to ‘strongly agree’. Patients will be asked to rate the importance of each listed indicator using a five-point Likert scale with the anchors form ‘not at all important’ to ‘extremely important’.

Study Timeline

January 2015 – June 2016

Progress

A systematic review and development of the preliminary list of quality indicators for HF have been completed.

Research Team

Valeria Rac, MD, PhD
Lusine Abrahamyan, MD, MPH, PhD
Yelena Petrosyan, MD, MPH, PhD
Yeva Sahakyan, MD, MPH
Austin Nam, BSc, MSc
Nida Shahid, HBSc

Funding

Ontario Ministry of Health and Long-Term Care (MOHLTC)

 

Purpose

The study aims to provide a comprehensive evaluation framework for the Value Demonstrating Initiative (VDI) on Chronic Obstructive Pulmonary Disorder (COPD) program that will include an evaluation of project implementation, patient enrollment, patient and provider experiences of care, and program impact on clinical, economic and humanistic outcomes. A mixed-method study design will be utilized.

The VDI on COPD program is a collaborative effort between the Ontario Lung Association (OLA), the Ministry of Health and Long-Term Care (MOHLTC), and Canada’s Research Based Pharmaceutical Companies (Rx&D). This innovative program targets COPD patients in Ontario who are at risk of acute exacerbation and subsequent ED admission or hospitalization. It aims to improve patients’ quality of life and the efficiency of healthcare system via systematic identification of these patients and timely provision of integrated, multidisciplinary community-based care coordinated by a case manager that is tailored to patient needs and severity of the disease.

Research Questions

The primary objective of the project is to evaluate if VDI on COPD program reduces COPD-related hospitalizations/ emergency department (ED) visits at the end of one year of program enrollment, compared to COPD-related hospitalizations/ED visits one year before the enrollment.

The secondary objectives are to evaluate:

1. The effectiveness (with potential barriers and facilitators) of the patient identification process, patient screening and enrollment.
2. The feasibility of program implementation (with potential barriers and facilitators) into routine practice and effectiveness of patient care coordination.
3. Stakeholders’ experiences with VDI on COPD in general and specifically regarding different program components.
4. Improvements in processes of care as measured by quality indicators (i.e., referral and access to care components).
5. The impact of the program on patient clinical, economic and humanistic outcomes at 1-year follow-up.
6. What aspects of the multidisciplinary program (or combinations) most contribute to the outcomes.
7. The cost-effectiveness of VDI on COPD program.

Inclusion Criteria

Patients:
All patients who meet VDI on COPD program eligibility criteria will be invited to participate in the evaluation study during the study’s accrual period.

VDI on COPD program will enroll patients who have:
• Post-bronchodilator FEV1/FVC ratio of <0.70 at all stages of post-bronchodilator FEV1 severities.
   AND
• 1 or more hospitalization(s)/ED visit(s) for COPD exacerbation requiring the use of systemic corticosteroids and/or antibiotics in the past 12 months at all stages of FEV1.
   OR
• 1 or more primary care clinic visit(s) for COPD exacerbations requiring the use of systemic corticosteroids and/or antibiotics in the past 12 months AND post-bronchodilator FEV1 < 80% predicted.

Health Care Provider, Administrator and/or Decision Maker:

1. Any health care provider who referred a patient to the VDI on COPD program
2. Primary care providers of patients who are enrolled in the study
3. VDI on COPD case managers involved in the provision of care to patients enrolled in the program
4. For interviews and surveys, stakeholders must have three months experience with VDI on COPD program
5. Administrators and/or Decision Makers of the VDI on COPD program as a larger network of care (e.g. Program Managers, key members of the MOHLTC, LHIN, CCAC managers etc.)

Exclusion Criteria

Patient:
• Primary diagnosis of asthma, palliative care COPD patients, uncontrolled psychiatric illness, dementia, and being a resident in a long term care facility with high level of dependency.

Health Care Provider, Technician, Administrator and/or Decision Maker:
• Unable or unwilling to provide verbal informed consent

Design and Methods

Study 1: Implementing VDI on COPD in Ontario (Qualitative study addressing secondary objectives 1-3)
Participants will be recruited in a purposive fashion employing maximum variation sampling. It is planned to interview 25 health care providers and 30 patients across all sites (55 interviews in total), where 20 interviews will happen in Phase 1 (year 1) and remaining 35 later, in Phase 2. The final sample size will be determined by thematic saturation. We will interview stakeholders who had at least three months experience of VDI on COPD program. Open-ended, semi-structured interview guides have been developed for the study. One-on-one interviews will be conducted by trained interviewers with qualitative research expertise. All interviews will be conducted in person, and will be audio-taped, transcribed verbatim and coded by the research team. Data collection and analysis will take place concurrently and will follow an iterative process. Key concepts and an analytic framework will be developed that will interpret and account for the empirical data. Qualitative findings will be used to inform other data analysis (triangulation of data). Relevant documentary sources will also be reviewed to further add to the data collection.

Study 2: Effectiveness and Cost-Effectiveness of VDI on COPD program (Quantitative study addressing primary objective and secondary objectives 4-7)
Study 2 will evaluate processes of care, the effect of VDI on COPD program on clinical, economic (e.g., health care utilization, costs and cost-effectiveness) and humanistic outcomes (e.g., quality of life, adherence).

The study will utilize a quasi-experimental, one-group pre-post study design where the outcomes will be compared at 1 year before and after the VDI on COPD program enrollment. Patient baseline information will be obtained at their first visit, after which patients will participate in one year VDI on COPD program. The primary outcome, the rate of COPD-related hospitalizations and/or ED visits at the end of one year will be first collected using patient self-report and then ascertained from the health administrative databases of Ontario.

Study Timeline

Run-in period: initial 3-month period to operationalize the implementation and pilot data collection
Enrollment: 6 months
Follow-up: 1 year
Total study duration: 3 years

Research Team

Murray Krahn, MD, MSc, FRCPC
Michael Hillmer, PhD
Valeria Rac, MD, PhD
Lusine Abrahamyan, MD, MPH, PhD
Petros Pechlivanoglou, PhD
Nicholas Mitsakakis, MSc, PhD
Dr. Reza Maleki-Yazdi, MD, FRCPC, FCCP
Suzanne Chung, BEd, CCRP

Funding

Ontario Lung Association (OLA)

Purpose

In April 2007, Ontario has launched the MedsCheck Annual program – a medication review led by community pharmacists for patients taking at least three prescription medications for a chronic condition. The overall aim of this study is to evaluate the effectiveness and cost-effectiveness of this program in Ontario.

Research Question

The study has five sub-projects where 1-3 are collaborative projects between THETA and The Ontario Pharmacy Research Collaboration (OPEN) research groups. The specific objectives of each project are:

    Project 1: Describe the users of MedsCheck Annual (MCA) services in Ontario from 2007-2013 and the service uptake.

    Project 2: Evaluate patient, pharmacy and community-level factors that affect the likelihood of receiving an MCA in     Ontario.

    Project 3: Evaluate the effectiveness of the MCA program in Ontario seniors.

    Project 4: Evaluate the cost-effectiveness of the MCA program in Ontario seniors.

    Project 5: Explore the ‘real world’ context of MedsCheck reviews and the experiences of providers (i.e. pharmacists,     trainees, technicians) and patients.
 

Inclusion Criteria (varies by project)

• Patient-pharmacy encounters of all Ontario patients above 65 years old who were eligible to receive an MCA review at pharmacy visits anytime between April 1, 2008 and March 31, 2013 will be included.

• MedsCheck (intervention) cohort will include all Ontario patients above 65 years old who had their first MCA review conducted anytime between April 1, 2008 and March 31, 2010 (study accrual period).

• We will employ purposive sampling to select four pharmacies that vary in type (chain/banner; independent) and location (smaller more intimate community setting; larger more anonymous urban setting).

Exclusion Criteria (varies by project)

• All other patient-pharmacy encounters during the selected time period when the patient was on less than three chronic medications will be excluded.

• All other patients in the Ontario Drug Benefit (ODB) database during the study accrual period that were not eligible to receive MCA review by the study’s established criteria will be excluded.

• Patients who receive MedsCheck Annual Diabetes or Home reviews are no not eligible for MCA.

Design and Methods

The study will utilize a mixed-methods design by combining quantitative (Projects 1-4) and qualitative (Project 5) research methods. Projects 1-4 will use linked administrative databases at the Institute for Clinical Evaluative Sciences (ICES). Project 5 will utilize ethnographic observations, ethnographic interviews and in-depth semi-structured interviews in four pharmacy sites.

Study Timeline

September 2013 – June 2016

Research Team

THETA Team:
Murray Krahn, MD, MSc, FRCPC
Valeria Rac, MD, PhD
Lusine Abrahamyan, MD, MPH, PhD (Project Lead)
Petros Pechlivanoglou, PhD
Fiona A. Miller, MA, PhD
Sarah Jessica Patton, MA
Susanne Priest, MScPhm MBA
Nicholas Mitsakakis, MSc, PhD
Suzanne Chung, BEd, CCRP
James Bowen, BScPhm MSc
Paul Grootendorst, PhD
Job van Boven, PharmD MSc
Mohammed Mahdi, BScPhm PharmD

OPEN Team:
Linda D. MacKeigan, BSc, Phm, PhD (lead)
Lisa Dolovich, BScPhm, PharmD, MSc (co-lead)
Nedzad Pojskic, HonBSc, MSc, PhD
Suzanne Cadarette, BSc, MSc, PhD
Andrea Burden, BSc, MA, PhD
Giulia Consiglio, BSc, MSc
Lori MacCallum, BScPhm, PharmD
Elizabeth Bojarski, BA, MPH

Funding

Blueprint for Pharmacy

Purpose

To estimate the direct medical care costs of childhood cancer from a health system perspective, and to determine which elements influence these costs.

Research Questions

Using cancer registry and administrative data linked within each of BC and ON, we propose to:

1. Estimate the costs of care overall and for four groups of childhood cancer (3 most common types: leukemia, central nervous system tumours, and lymphoma, and a fourth consisting of all other cancers) for three phases of care: initial, continuing/survivor, and terminal.
2. Determine the main sociodemographic, clinical, and health system predictors of costs, overall and for each cancer group, and each costing phase.
3. Measure time trends in health service utilization and costs during the first year after diagnosis, overall and for each childhood cancer group and relate temporal changes to changes in treatment and the frequency of late complications.
4. Estimate 1-year, 5-year, and 10-year costs overall and for the most common cancers using the phase-based costing approach and appropriate statistical methods.

Inclusion Criteria

Study cohorts will be identified from the Childhood/Adolescent/Young Adult Cancer Survivors (CAYACS) Research Program at the British Columbia Cancer Agency and the Pediatric Oncology Group of Ontario Network Information System (POGONIS) at the Pediatric Oncology Group of Ontario (POGO). We will select patients diagnosed from January 1, 1995, to December 31, 2010, at ages 0 to 19 years with a cancer or tumour included in the International Classification of Childhood Cancers (ICCC).

Exclusion Criteria

We will exclude patients who have an incorrect or missing histology code, a date of diagnosis that is the same as the date of death, not residents of British Columbia or Ontario at diagnosis, or do not have a valid Medical Services Plan number or Ontario Health Insurance Plan number.

Design and Methods

Each province will work with its own data. In Ontario, all analyses will be conducted at the Institute for Clinical Evaluative Sciences. We will link the cases identified in POGONIS to their health care administrative data and determine use and estimate costs for the following health care resources: inpatient hospitalization, emergency department visits, lab and diagnostic tests, physician services, prescription drugs, chemotherapy, radiation therapy, palliative care. home care. We will also estimate net cancer-related costs by identifying a non-cancer control group. Total and net health care costs will be estimated and analyzed to address the research questions.

Study Timeline

July 2012 - December 2015

Progress: Costs for 90 days before diagnosis and one year after diagnosis, phase-specific costs,and time trends in first-year costs have been estimated for the childhood cancer cohort in Ontario. Estimation of costs for longer time periods is underway. An oral presentation on first-year costs was givenat the conference of The Canadian Association for Population Therapeutics , November 1 – 3, 2015 in Toronto, Ontario. A manuscript is being prepared for journal submission. Other manuscript preparation is underway.

 

Research Team

Mary McBride Mark Greenberg
Paul Nathan
Paul Rogers
Stuart Peacock
Karen E. Bremner, BSc

Funding

Canadian Institutes of Health Research

Purpose

i) to develop two sets of utility weights, patient derived and community derived, for the BUSS-P, a bladder cancer-specific health state classification system:

ii) to compare patient-derived to community-derived utility weights.

Research Question

To develop an algorithm which will convert the BUSS-P to the BUSS-U by mapping each possible health state to a utility on a scale anchored at zero (dead) and 1.0 (full health).

Inclusion Criteria

Patients: Bladder cancer patients (n=200) will be recruited from ambulatory clinics at the University Health Network (Toronto) and the London Health Sciences Centre. Inclusion criteria are a confirmed diagnosis of bladder cancer, fluency in English, no documented cognitive impairment and age ≥ 18 years.

Community respondents (n=200) will be recruited from both sites via posted notices in family medicine clinics and hospital common areas. Non-bladder cancer patients, family members of patients and members of the general public who never had bladder cancer, are fluent in English, have no cognitive impairment and are age ≥ 18 years will be eligible for inclusion.

Exclusion Criteria

• undergoing concurrent (active) treatment for a second malignancy, other than non-melanoma skin cancer

• inability to provide written informed consent

Design and Methods

We propose to fit a regression model to data on preferences for health states described by the BUSS-P, using the statistical inference approach to developing weights for multiattributed outcomes. The statistical inference or composite approach, allows valuation of a sample of realistic health states described by the BUSS-P, which can then be mapped onto a scale anchored at 0 (dead) and 1 (full health) using regression techniques. In structured individual interviews, each respondent will be asked to provide TTO utilities on 18 health states (15 randomly selected + two anchor states [worst on all 10 attributes and best on all 10 attributes] + own current health). We will explore different regression models, using non-parametric Bayesian methodology, to develop the best-fitting, most parsimonious utility function for the BUSS-U.

Study Timeline

March 2014 –  December 2018

Progress: We have Research Ethics Board approvals and we have prepared the props for the utility elicitation interviews.

Research Team

Murray Krahn, MD, MSc, FRCPC
Girish Kulkarni, MD, PhD, FRCSC
Nathan Perlis, MD, MSc
Shabbir Alibhai, MD, MSc, FRCPC
George Tomlinson, PhD
Antonio Finelli MD, MSc, FRCSC
Srikala Sridhar, MD, FRCPC
Peter Chung, MD, FRCPC
Joseph Chin, MD, FRCPC
Karen Bremner, BSc
Kirstin Boehme, MSc
Steven Carcone, MSc
Suzanne Chung, BFA, BEd, CCRP

Funding

Canadian Cancer Society Research Institute

 

Purpose

The purpose of this study is to develop and validate a disease-specific utility instrument for use among individuals with bladder cancer.

Research Question

Phase I: Develop a multiple domain health state classification system (complete)

Phase II: Test its psychometric properties (e.g. sensibility, reliability, validity)

Inclusion Criteria

We will identify patients at bladder cancer clinics at the Toronto General Hospital and Princess Margaret Hospital and include those with pathologically-confirmed bladder cancer diagnosis, but no concomitant cancer other than non-melanoma skin cancer. Patients must have records of bladder cancer treatment history available, speak and write English fluently, and have a life expectancy of at least 4 weeks.

Exclusion Criteria

Exclusion criteria are inability to provide written informed consent.

Design and Methods

Phase I of the study involves:

1. Setting a conceptual framework;
2. Item generation via literature review, as well as patient and expert focus groups;
3. Item reduction via patient interview;
4. Defining levels and language;
5. Setting a scoring scheme;
6. Expert and patient pilot-testing.

Phase II is a multi-site validation study, whereby the BUSS’s validity and reliability will be evaluated through field testing. The BUSS will be administered to bladder cancer patients alongside several other quality of life instruments, during two testing sessions completed four to six weeks apart. Validity will be evaluated by assessing the correlations between instruments (whole-scale and subscale (e.g., urinary function) measurements) and comparing the BUSS scores between clinical groups using mean score differences. An analysis of the consistency of participants’ BUSS scores at session I versus session II, measured using the intraclass correlation coefficient, will be used to assess test-retest reliability.

Study Timeline

October 2012 –  September 2017

Progress: Patient recruitment and data collection are complete. Preliminary results were presented at the American Urological Association Annual Meeting, May 15-19, 2015, in New Orleans, USA. Furher analyses are underway.

Research Team

Murray Krahn, MD, MSc, FRCPC
Girish Kulkarni, MD, PhD, FRCSC
Nathan Perlis, MD, MSc
Shabbir Alibhai, MD, MSc, FRCPC
Antonio Finelli MD, MSc, FRCSC
Paul Ritvo, PhD
Kirstin Boehme, MSc
Karen Bremner, BSc

Funding

Canadian Institutes of Health Research