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HCV UTILITY PILOT STUDY: MEASURES OF QUALITY OF LIFE AND UTILITY AMONG PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION

Purpose

We have identified two important knowledge gaps in understanding the burden of Hepatitis C Virus (HCV):

  1. The utilities of Chronic Hepatitis C (CHC) patients who have late stage liver disease (decompensated cirrhosis (DC) and Hepatocellular Carcinoma (HCC)) are poorly understood.
  2. Most costs studies and utility studies have been conducted in tertiary care clinics. There are no studies on patients receiving care in the community.

We propose to measure the patient burden of HCV. This includes Health-related Quality of Life (HRQL) and health utilities in patients across CHC disease stages. It also includes the effect of HCV on workplace productivity, and costs borne by patients and families across different health care settings. This information will be useful for patients, doctors, and policy makers to make decisions on the new CHC treatments. Our results will have significant impacts on drug reimbursement policies and on guidelines for population screening.

Research Question

What are patients’ burdens of HCV, including HRQL and health utilities, across CHC disease stages?

Design and Methods

This is a multi-centre cross-sectional study, employing 7 self-reported questionnaires. The study cohorts will be selected from CHC-infected individuals attending tertiary care clinics or inpatient units of the University Health Network (UHN), or attending one of the 3 community clinics of the Toronto Community Hepatitis C Program (TCHCP) at Regent Park Community Health Centre, South Riverdale Community Health Centre and Sherbourne Health Centre. The tertiary care clinic patients are mostly middle class whereas most community clinic patients are from high-risk populations such as the homeless and intravenous drug users. We predict that their utilities will also differ.

Inclusion Criteria

Patients diagnosed with CHC without cirrhosis or HCC; or CHC with cirrhosis (compensated or decompensated); or CHC with HCC.

Exclusion Criteria

• Unable or unwilling to provide informed consent

• Psychiatric disorder impeding comprehension and completion of questionnaires

• Life expectancy of less than six months.

Progress

We have recruited 285 participants and have presented our preliminary findings in the 37th and the 38th Annual Meeting of the Society for Medical Decision Making and the 5th Canadian Symposium on Hepatitis C Virus. We are preparing the manuscript for publication.

Study Timeline

January 2015 – March 2017

Research Team

William Wong, PhD
Murray Krahn, MD, MSc, FRCPC
Karen Bremner, BSc
Julie Bruneau, MD, MSc
Jordan Feld, MD, MPH
Zeny Feng, PhD
Samuel Lee, MD
Kate Mason, MHSc
Nicholas Mitsakakis, MSc, PhD
Robert Myers, MD, FRCPC
Petros Pechlivanoglou, PhD
Jeff Powis, MD, FRCPC
Valeria Rac, MD, PhD
Josephine Wong, MD
Yasmin Saeed, PhD (Candidate)

Funding

CIHR Operating Grant

Publications / Presentations

Saeed Y, Mason K, Chung S, Altenberg J, Powis J, Bruneau J, Feld J, Feng Z, Mitsakakis N, Myers R, Rac V, Bremner K, Krahn M, Wong W. Health utilities in marginalized chronic hepatitis C patients participating in a community-based hepatitis C program. 37th Annual Meeting of the Society for Medical Decision Making, October 17-21, 2015. St. Louis, MO, USA.

 

 

SIESTA: HOME SLEEP STUDY WITH BresoDx® FOR THE DIAGNOSIS OF OBSTRUCTIVE SLEEP APNEA

Purpose

The purpose of this study is to assess the clinical and cost-effectiveness of obstructive sleep apnea (OSA) diagnosis based on a home sleep study with  BresoDx® portable monitor compared to diagnosis based on in-laboratory sleep study with polysomnography in patients being referred to sleep clinics with suggestive OSA symptoms.

Research Questions 

  1. How does the clinical diagnosis of OSA assisted by the home sleep study with  BresoDx® in comparison with the clinical diagnosis assisted by the in-laboratory sleep study with PSG as the reference standard?
  2. What is the agreement between the AHI from the home sleep study with  BresoDx® and the in-laboratory sleep study with PSG?
  3. What is the cost-effectiveness (cost per quality-adjusted life year) of the OSA after diagnosis based on home sleep study with  BresoDx® in comparison with after diagnosis based on an in-laboratory sleep study with PSG?

Inclusion Criteria

  1. Referral to a sleep clinic by a general practitioner or family physician with symptoms suggestive of OSA
  2. Provide signed informed consent
  3. At least 18 years of age
  4. Ability to complete study questionnaires either on their own or with assistance

Exclusion Criteria

  1. A history of chronic respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease, lung cancer, cystic fibrosis and occupational lung diseases)
  2. An existing diagnosis of other sleep disorders (e.g. periodic limb movement disorder)
  3. A history of neuromuscular diseases (e.g., multiple sclerosis, muscular dystrophy)
  4. A history of congestive heart failure
  5. A history of stroke/Transient Ischemic Attack
  6. Unable or unwilling to provide informed consent

Design and Methods

The SIESTA Home Sleep Study is a pragmatic, multi-centre randomized single-blinded two arm trial. This study focuses on subjects referred to a sleep clinic with symptoms suggestive of OSA. Study subjects will be randomized by a ratio of 1:1 to a sequence of home sleep study with the  BresoDx® PM followed by an in-laboratory sleep study with PSG (the PM-PSG sequence) or the PSG-PM sequence. The target sample size is 250 subjects from 3-4 sleep clinics over a 4-5 month period evenly allocated between the two arms. 

  

Study Timeline

The study started recruitment in March 2014 and finished in March 2016. The manuscript preparation is underway.
 

Research Team

Murray Krahn, MD, MSc, FRCPC 
Mike Fitzpatrick, MD, FRCPI, FRCPC, D.ABSM  
Valeria E. Rac, MD, PhD 
Lusine Abrahamyan, MD, MPH, PhD 
Suzanne Chung, BEd, CCRP 
 

Funding

MaRS EXCITE

Publications/Presentations

Oral Presentations

2017 CADTH Symposium will be in Ottawa, Otario, from April 23, 2017 to April 25, 2017

Economic Evaluation of a Portable, Home-Testing Device (BresoDx) for Obstructive Sleep Apnea. Petros Pechlivanoglou

Diagnostic Accuracy of Level IV Portable Sleep Monitors Versus Polysomnography for Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. Lusine Abrahamyan

SIESTA Home Sleep Study With BresoDx Portable Monitor for the Diagnosis of Obstructive Sleep Apnea: A Pragmatic Randomized Controlled Trial. Valeria Rac

 

 

Mapping the Myelofibrosis Symptom Assessment Form (MFSAF) and Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) to the EQ-5D

Purpose

The purpose of this study is to develop a statistical model in order to map between Myelofibrosis (MF) specific Health Related Quality of Life instruments using the Myelofibrosis Symptom Assessment Form (MFSAF) and Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) and generic preference based utility instrument using EQ-5D. This will enable the estimation of utility values based on MFSAF and MPN-SAF data.

Research Questions

What is the mapping algorithm between two different types of instruments by using a simple linear regression method?

Inclusion Criteria

  1. Patients with myelofibrosis from any English speaking countries including Canada, America, Australia, and England
  2. Family members of myelofibrosis patients if patients are unable to participate the study by themselves
  3. MF patients who can read, write, and speak English and complete the questionnaires

Exclusion Criteria

No specific exclusion criteria

Design and Methods

The study is composed of three parts: a) a systematic review of regression methods previously used for mapping, b) design and conduct of a survey of Myelofibrisis patients (including challenges arisen during the study), and c) the analysis of the survey data and mapping using statistical regression methods, which is the main part of the study. Patients with myelofibrosis from English-speaking countries will be asked to complete questionnaires which include both MFSAF/MPN-SAF and EQ-5D. Patients will be recruited through two ways: 1) online survey system using Survey Monkey or 2) direct mail out. Patients can choose the method to be participated.

Study Timeline

September 2013 - October 2015

Progress: Analyses are completed. A report was sent to Sanofi-Aventis Canada, the sponsor. Manuscripts are under preparation

Research Team

Murray Krahn, MD, MSc, FRCPC 
Karen Bremner, BSc
Chang-Ho Lee, BSc Honours

Funding

Sanofi - Aventis Canada, Inc.

Publications / Presentations

Lee CH, Bremner K, Grootendorst P, Ringash J, Krahn M, Mitsakakis N. Predicting utility scores for myelofibrosis patients: mapping the myelofibrosis symptom assessment form and myeloproliferative symptom assessment form to the EUROQOL-5D. 37th Annual Meeting of the Society for Medical Decision Making, October 17-21, 2015. St. Louis, MO, USA.

 

 

Ontario Stroke UNits (OSUN)

Purpose

Comparison of acute stroke care received at stroke units (SUs) to the care received in general medical wards (GWs) (i.e. care not received at SUs), specifically evaluating cost-effectiveness and characteristics associated with stroke unit care.

Research Questions

The primary research questions are:

  1. What are the characteristics of SUs in Ontario (i.e. frequently occurring, common characteristics)?
  2. Are SUs effective, as currently structured in Ontario?
  3. Are SUs cost-effective, as currently implemented in Ontario (i.e. what are the resources used and associated costs)?
  4. What SU characteristics are associated with improved patient- and system-level outcomes?

Design and Methods

The primary objective of the current research is to use a survey of hospitals in Ontario and data available from the Ontario Stroke Audit (OSA) to identify which specific characteristics of Ontario SUs appear to be (cost-) effective and are associated with improved patient outcomes, in comparison to GWs.

The characteristics of SUs in Ontario will be based on a telephone survey administered to all known SUs in Ontario. The comparative effectiveness and cost-effectiveness analyses will be based on the Ontario Stroke Audit (OSA) administrative database maintained by ICES.

Study Timeline

January 2013 - June 2016

Progress: Data collection started in January 2013.The final report has been completed and submitted to Ontario Stroke Network (OSN). The preparation of manuscripts is in progress.

Research Team

Murray Krahn, MD, MSc, FRCPC 

Mark Bayley, MD, FRCPC
Moira Kapral, MD, Msc, FRCPC
Valeria E. Rac, MD, PhD
Luciano Ieraci, MSc
Gabrielle van der Velde, DC, PhD
Ruth Hall, BSc, MSc, PhD
Linda Kelloway, RN, MN, CNN(c)

Funding

Ontario Stroke Network (OSN)

Presentations/Publications

Rac VE, Sahakyan Y, Fan I, Luciano Ieraci, Ruth Hall, Linda Kelloway, Gabrielle van der Velde, Moira K. Kapral, Mark Bayley, Murray Krahn.The characteristics of stroke units in Ontario: a pan-provincial survey. BMC Health Services Research 2017 Feb;17:154. DOI 10.1186/s12913-017-2099-1

Sahakyan Y, Rac VE, Fan I, Ieraci L, Hall R, Kelloway L, van Velde G, Kapral MK, Bayley M, Krahn MD. Structure and function of stroke units in Ontario in 2013-2014. Presented at: Toronto General Research Institute (TGRI) Research Day, October 6, 2015; Toronto ON, Canada.

Ieraci L, Pechlivanoglou P, Bayley M, Kapral M, Fang J, Li S, Krahn M. Real-world effectiveness of stroke units in Ontario. A matched cohort analysis. Presented at: 2015 Canadian Association for Health Services and Policy Research (CAHSPR) Policy Forum; March 24, 2015; Toronto ON, Canada.

Rac VE, Sahakyan Y, Fan I, Ieraci L, Hall R, Kelloway L, van der Velde G, Kapral M, Bayley M, Krahn M. Structure and Function of Stroke Units in Ontario in 2013-2014. Poster session presented at: 2015 Canadian Association for Health Services and Policy Research (CAHSPR) Policy Forum; March 24, 2015; Toronto ON, Canada.

 

END-OF-LIFE CARE INTERVENTIONS: AN ECONOMIC ANALYSIS

Purpose

The annual cost of providing health care for patients in their last year of life is estimated to account for approximately 9% of the Ontario healthcare budget. Access to integrated and comprehensive pain and symptom management and comfort support for these patients appears to be inadequate and inequitable. We evaluated the cost-effectiveness of palliative care interventions to support policy development.

Research Question

What is the cost-effectiveness of evidence-based interventions for end-of-life care?

Inclusion Criteria

Not applicable.

Exclusion Criteria

Not applicable.

Design and Methods

Cost-effectiveness and cost-utility analyses from a health-care payer’s perspective. Target population: patients nearing end-of-life (according to observed population-based setting-specific patterns of palliative services) over the last year of life (one-year time horizon) and their primary informal caregivers. Comparators: “usual care” with current provision of palliative services in Ontario, “in-home” palliative team care (service provision either at home or long-term care), “in-patient” palliative team care, and “comprehensive” palliative care by a single team with care coordination across settings.

We included health care costs (2013 Canadian dollars; including home care, long-term care, hospital care, outpatient services, drugs, and physician billing costs), and additional costs of private insurance, out-of-pocket expenses, and time lost from paid work. Effectiveness measures were days at home, percentage dying at home (base case analysis), and quality-adjusted life days (QALD; sensitivity analysis).

We developed a state-transition microsimulation model to simulate palliative care needs by the target population. Model inputs were obtained from an end-of-life cohort of Ontarian decedents (n= 256,284) assembled from linked health administration databases (2007-2009), systematic reviews of randomized controlled trials evaluating palliative team care, and published literature. We conducted one-way and probabilistic sensitivity analyses.

Study Timeline

September 2014 – December 2014

Research Team

Ba' Pham, MSc, PhD

Robert Fowler, MD, MS, FRCPC
Peter Tanuseputro, MHSc, MD, CCFP, FRCPC  
Doug Manuel, MD, MSc, FRCPC  
Nancy Sikich, MSc  
Shamara Baidoobonso, PhD  
Petros Pechlivanoglou, MSc, PhD
Les Levin, MB, MD(Birm), FRCP(Lon), FRCPC  
Murray Krahn, MD, MSc, FRCPC, on behalf of the Health Quality Ontario Expert Panel on End-of-Life Care, and the Toronto Health Economics and Technology Assessment Collaborative 
 

Funding

Health Quality Ontario

Publications/Presentations

Ba' Pham, MSc, PhD (c) , Robert A. Fowler, MD, MSc, Peter Tanuseputro, MD, MHSc, Douglas Manuel, MD, MSc, Nancy Sikich, MSc, Shamara Baidoobonso, MSc, PhD, Petros Pechlivanoglou, PhD, Les Levin, MD, MSc and Murray D. Krahn, MD, MSc. Cost-Effectiveness Analysis of Palliative Team Care for Patients Nearing End-Of-Life. Presented at: 36th Annual Meeting of the Society for Medical Decision Making; 2014 Oct 18 - 22; Miami, FL, USA.

 

 

ESTIMATING THE PROGNOSIS OF CANADIANS INFECTED WITH THE HEPATITIS C VIRUS THROUGH THE BLOOD SUPPLY, 1986-1990

Purpose

To estimate future treatment patterns with newly developed antiviral regiments for chronic hepatitis C (CHC) and update model predictions on long-term health outcomes in a Canadian hepatitis C compensation cohort.

Research Question

How will the newly developed antiviral regimens affect long-term health outcomes associated with compensation claimants with CHC?

Inclusion Criteria

Canadians who have been approved for compensation because of their acquired CHC during the period of 1986 to 1990.

Exclusion Criteria

Not applicable.

Design and Methods

A physician survey will be designed to understand the impact of new antiviral agent on treatment patterns with CHC who have similar background with the compensation cohort. A systematic review will be conducted to estimate their efficacies and toxicity by previous history of antiviral therapy and HIV co-infection. We will also maximize the use of the claim cohort data to estimate model variables and modify model structure according to the estimated future treatment patterns. Microsimulation will be run with the updated prognostic model to project lifetime risks of liver-related complications and mortality in current surviving compensation claimants. Sensitivity analyses will be also performed to explore the impact of model variable data sources, treatment pattern, and treatment uptake timeframe on model prediction.

Study Timeline

September 2013 - August 2014

Research Team

Murray Krahn, MD, MSc, FRCPC 
Wendong Chen, MD, PhD
Qilong Yi, MD, PhD  
 

Funding

The 1986-1990 Hepatitis Settlement Trust Fund

 

 

BAYESIAN REGRESSION MODELS FOR ESTIMATION OF DISEASE-SPECIFIC NET COSTS USING AGGREGATE DATA

Purpose

To investigate the application of a novel statistical approach for the estimation of net costs attributed to a disease or health condition when only aggregate data are available and provided as collection of sample means and standard deviations for a number of strata. The proposed method is based on the application of a Bayesian Gamma mixed effects model, where both sample means and standard deviations are participating as stochastic nodes in the Bayesian model. The method is evaluated and compared with two simpler Bayesian Normal models using a series of simulation experiments.

Research Question

Does the proposed Bayesian Gamma mixed effects model offer an improvement for the estimation of net costs over simpler normal linear models, when only aggregate data are available?

Design and Methods

This is a study of development of statistical methods, using a series of simulation experiments.

Study Timeline

Oct 2010 – present (manuscript under revision)

Research Team

Nicholas Mitsakakis, MSc, PhD
George Tomlinson, MSc, PhD

 

COMPARISONS OF END OF LIFE CARE IN LUNG CANCER PATIENTS IN THE USA AND CANADA

Purpose

To determine patterns of care and costs during the last 6 months of life for patients with late-stage non-small cell lung cancer (NSCLC) in Ontario compared to the United States.

Research Questions

Part 1: Are there differences in the health care provided to lung cancer patients at the end of life in Ontario compared to the United States, two countries with similar populations but very different health care systems.

Part 2: Do the costs of care differ in Ontario compared to the United States

Inclusion Criteria

The Ontario cohort will be identified from the Ontario Cancer Registry. We will include patients with lung cancer (ICD9 162) who died of any cancer at age >65.5 years between January 1, 1999 and December 31, 2003 (Part 1) or between January 1, 1999 and December 31, 2006 (Part 2), and survived at least 30 days following the cancer diagnosis.

Exclusion Criteria

We will exclude patients who had any other primary cancer diagnosis besides lung, or had cancer-directed surgery within one year after diagnosis (to select advanced stage cancer), or had invalid Ontario Hospital Insurance Plan number, or who died outside of Ontario.

Design and Methods

Data from the two countries will not be combined; we will compare frequency data with chi-square statistics, and compare means, SE and confidence intervals for continuous data.

The US team will use data from the linked SEER-Medicare databases. In Ontario, we will use administrative databases at the Institute for Clinical Evaluative Sciences to determine quantities of health care resources, such as emergency room visits, inpatient stays, chemotherapy, and home care, used in the last 6 months of life and assign costs to them. For Part 1 of the study we will report resource use in patients who died 1999-2003. We will  update the cohort for Part 2 to include patients who died 1999-2005 (more recently linked SEER-Medicare data will be available when we start Part 2) to estimate the costs associated with health care services, using a previously developed costing methodology for the Ontario patients, and charges to Medicare for the US patients. Comparisons between and within countries over time will indicate how two different health care systems care for lung cancer patients at the end of life, and how much this care costs.

Study Timeline

June 2008 to March 2014

Research Team

Murray Krahn, MD, MSc, FRCPC 
Lisa Barbera Joan Warren
Robin Yabroff
Karen Bremner, BSc

Funding

Cancer Care Ontario
Canadian Centre for Applied Research in Cancer Control (ARCC)

 

ANDROGEN DEPRIVATION THERAPY IN PROSTATE CANCER PATIENTS: PATTERNS OF CARE, LIFETIME COSTS, AND COST-EFFECTIVENESS OF ADT

Purpose

To describe patterns of use, type and indication of androgen deprivation therapy (ADT) in prostate cancer patients in Ontario, and determine costs of ADT and its side effects.

Research Questions

  1. To determine the overall use and useof different types of ADT and its indications in the treatment of prostate cancer.
  2. To estimate costs for various types of ADT used for each indication.
  3. To estimate the incidence and costs of several of the most common side effects of ADT

Inclusion Criteria

The cohort will include Ontario Cancer Registry (OCR) patients assigned International Classification of Diseases-Oncology (ICD O) topography code C61.9 (cancer of the prostate) who had either bilateral orchiectomy or who received ADT pharmacotherapy for 3 consecutive months between January 1, 1995 and December 31, 2005, at age > 65.5 years, and who had no ADT therapy prior to January 1, 1995 or before age 65.5 years.

Exclusion Criteria

Exclusion critera are missing histology codes date of diagnosis the same as date of death, sex coded as female or missing, residence outside of Ontario, and no valid Ontario Health Insurance Number.

Design and Methods

Analyses will be conducted at the Institute of Clinical Evaluative Science. We will link all patients to their health care administrative data and classify patients according to the type of ADT they received and its indication, using available data and algorithms. We will determine patterns of care (type and indications of ADT) over the years of the study. We will estimate one-year, five-year, and ten-year total costs for each type and indication of ADT. In addition, the known side effects of ADT will be identified and their costs also estimated.

Study Timeline

April 2007 to December 2013

Research Team

Murray Krahn, MD, MSc, FRCPC 
Shabbir Alibhai, MD, MSc, FRCPC
Padraig Warde
Gary Naglie, MD, FRCPC
George Tomlinson, MSc, PhD
John Trachtenberg Paul Ritvo
Karen Bremner, BSc

Funding

Canadian Cancer Society Research Institute
New Drug Innovation Fund (Ontario Ministry of Health and Long-term Care)

 

BEYOND CASE FATALITY RATE: USING POTENTIAL IMPACT FRACTION TO ESTIMATE THE EFFECT OF INCREASING TREATMENT UPTAKE ON MORTALITY

Purpose

To investigate potential methodological improvements in the estimation of the effect that uptake treatment increase of various treatments has on mortality as it is implemented in the IMPACT epidemiological model. The effect is measured by the number of deaths prevented or postponed. The method currently used in IMPACT model has data limitations, which could lead into biased estimates. This study proposes a probabilistic framework for the estimations in the IMPACT model, and presents how this framework allows naturally the application of the Potential Impact Fraction (PIF), a traditional epidemiological tool, for the estimation of the effect. 

Research Questions 

What is the magnitude of the bias introduced by the traditional methods of the IMPACT model in the estimation of the number of deaths prevented or postponed? Can the appropriate application of PIF reduce or eliminate this bias under different settings and assumptions?

Design and Methods

This is a study of development of statistical and epidemiological methods. It includes application of methods to real data originally presented in a previous study (IMPACT 2).

Study Timeline

Jan 2011 – present (manuscript published)

Research Team

Nicholas Mitsakakis, MSc, PhD
Harindra Wijeysundera, MD, FRCPC
Murray Krahn, MD, MSc, FRCPC 

 

DEVELOPMENT OF AN ECONOMIC POLICY MODEL FOR HEPATITIS C

Purpose

To establish an economic model based on the best information available in the public domain on the natural history progression of hepatitis C to be used by Canadian Agency for Drugs and Technologies in Health (CADTH) to project long-term outcomes, costs and cost-effectiveness of interventions in treating hepatitis C to support clinical and reimbursement decision-making.   The objective of this study is to build a flexible model platform that can evaluate the cost-effectiveness of CHC drugs and drug regimens that will be brought forward to the Common Drug Review for evaluation in the next few years.

Study Timeline

March, 2013 – September, 2013

Research Team

Hong-Anh Tu, Ph.D
Jorden Feld, MD
Murray Krahn, MD, MSc, FRCPC
 

Funding

Canadian Agency for Drugs and Technologies in Health (CADTH)

 

COST-EFFECTIVENESS OF SCREENING HEPATITIS C IN CANADA

Purpose

Chronic hepatitis C (CHC) is often asymptomatic   and most individuals are not aware that they have been infected, thus the disease is often discovered when symptoms of late stage liver disease become apparent.  In Canada, it is estimated that roughly 250,000, or almost 0.8% of the population, is infected with hepatitis C virus (HCV).  Around 75% of those infected become chronically infected with the virus. 10-20% of whom will silently progress to cirrhosis and thereby be at risk of dying prematurely of liver failure and/or liver cancer.  Early recognition of CHC probably extends the lifespan of infected individuals.   Universal screening or screening for CHC among some high risk groups seems a plausible strategy.  However, the potential health effects, costs, and cost-effectiveness of implementing a universal or selective hepatitis C screening program are unknown.  The objective of this study is to build a model that can project the health and economic effects of various screening strategies for CHC conducted in different populations in Canada.

Study Timeline

July, 2013 – September, 2013

Research Team

Hong-Anh Tu, Ph.D
Jorden Feld, MD
Murray Krahn, MD, MSc, FRCPC
  

Funding

Public Health Agency of Canada (PHAC)

 

Canadian Institutes of Health Research Institute of Circulatory Respiratory Health Research Portfolio: Estimating Return on Investment

As part of an international review, the Institute of Circulatory and Respiratory Health sought to determine the effects of research on the health of Canadians. Specifically, the Institute was interested in comparing the benefits obtained from funded cardiovascular-related research with the cost of that research in order to obtain an estimate of the return on investment.

The objective of this report was to estimate the return on public/charitable sector investment of cardiovascular-related research funded in Canada for the years 1975-2005. To do so, we performed a return on investment calculation closely based on the work of Buxton and colleagues, who estimated the return on investment of cardiovascular research in the UK. We also incorporated in our analysis an existing model, the Ontario IMPACT model, which characterizes changes in the burden of cardiovascular disease between 1995 and 2005 in Ontario, and determines the relative importance of specific risk factors and treatments. Wherever possible, we attempted to improve on the methods and approaches reported in previous analyses.

Our analysis involved several steps. First, we estimated the expenditures on cardiovascular research in Canada. Second, we estimated the health gains accrued in Canada between 1995 and 2005 from new cardiovascular treatments and procedures. This involved determining the number of unique users of these cardiovascular treatments and procedures, determining the quality adjusted life-years (QALYs) gained by each unique user identified above and the associated health care costs of these treatments, and determining the QALYs and associated health care costs from smoking cessation and potential smokers averted and monetizing the total number of QALYs. Third, we estimated the proportion of health gains attributable to cardiovascular research funded in Canada. Fourth, we estimated the time-lag between research expenditures realised and health gains obtained. Finally, we estimated the research and development spillovers from public sector investments. Once all the steps were performed, we were able to calculate the rate of return on investment and the internal rate of return.

Given our assumptions, we obtained an internal rate of return of 20.6% for research funded by the public/charitable sector. This means that every $1 invested in cardiovascular disease research in the public/charitable sector will yield a stream of benefits of roughly $0.21 to the economy per year, in perpetuity. If we consider a 12% hurdle rate as the minimum acceptable rate of return for a given investment, then our internal rate of return of 20.6% is very good. This suggests that Canadians obtain relatively high health gains for every dollar spent on cardiovascular disease research. When we added private cardiovascular disease-related research expenditures to the public/charitable ones and considered the impact of research spillovers, we obtained a combined social rate of return of 44% (12.9% + 31%).

Our analysis was based on previous work but also provided some improvements. In particular, our study improved methods for estimating the number of unique users in each patient group/intervention; considered differential treatment of health gains for individuals that quit smoking and for non- starters; estimated Canada’s contribution to global medical research; modelled the time lag between incurred research expenditure and realised health gains as a distribution, among others.

This work involved many assumptions. Accordingly, there were some areas of uncertainty. For example, it was unclear what proportion of health gains can legitimately be assigned to research. We also did not evaluate risk factors other than smoking and thus, our calculated value for the internal rate of return was probably an underestimate.

Nonetheless, this research will guide the Canadian Institutes of Health Research in determining the value of its current research portfolio for cardiovascular disease research. In addition, it will provide valuable experience in conducting this type of work in Canada, which can potentially be used in other aspects of the portfolio of the Canadian Institutes of Health Research, or by other granting agencies. Finally, this may represent an opportunity to collaborate with other countries in establishing and refining methods to document the value of medical research.

 

Pressure Ulcer Multi-disciplinary Teams via Telemedicine (PUMTT):
A Cluster Pragmatic Randomised Controlled Trial in Long Term Care

FIELD EVALUATION

Purpose

The purpose of this study is to evaluate the clinical and cost effectiveness of 'enhanced' multi-disciplinary wound care teams (EMDTs) vs. 'usual' care teams (UCTs) for the treatment of pressure ulcers in long term care (LTC) facilities.

Research Questions

The primary research question is:
  • Do EMDTs increase the rate of pressure ulcer healing, measured by wound surface area (cm2) over time (days), relative to Usual Care Teams (UCTs)?
Secondary research questions are:
  • Is the use of EMDTs to increase the rate of pressure ulcer healing cost-effective?
  • Are EMDTs more effective than UCTs in healing a greater proportion of pressure ulcers?
  • Are EMDTs more effective than UCTs in reducing the facility-acquired incidence rates of pressure ulcers?
  • Are EMDTs more effective than UCTs in reducing wound related pain and discomfort?
  • What are LTC facility staff perceptions and experiences associated with EMDTs for pressure ulcer management?

Facility Inclusion Criteria

The LTC facility:
  • must be located within the Toronto Central or Central LHIN geographic boundaries.
  • must have > 100 beds.
  • must be within 100 Km of the EMDT.
  • must be entering data into MDS.
  • must have a PU prevalence rate > the provincial average (5.5%) reported in the fourth quarter of 2009 MDS.
  • administrator must consent to participate.

Design and Methods

This cluster, pragmatic randomised controlled trial is a mixed methods study employing quantitative and qualitative methodologies. The intervention will be delivered to 12 randomly selected facilities in the Greater Toronto Area according to a stepped wedge design consisting of three intervals: baseline (3-12 mos), Phase 1 (3 mos) and Phase 2 (2-11 mos). The study period is 17 months, with facilities randomly assigned to the start date of Phase 1. Usual care teams (UCTs) are the existing resident care personnel used in the LTC facilities to identify and treat PUs and other wounds. Enhanced multi-disciplinary teams (EMDTs) consist of an Advanced Practice Nurse (APN) who is regularly on-site who collaborates with the wound care team at St. Michael's Hospital. Phase 1 is a 12 week period where an Advanced Practice Nurse visits the LTC facility on a weekly basis and trains/mentors UCT staff as they assess and treat participating residents' PUs. The APN may consult other members of the EMDT via telemedicine, and/or certain residents may require transport to St. Michael's Hospital for on-site assessment and treatment. Phase 2 is of variable length and consists of primarily telemedicine contact between the UCT and EMDT via the APN (with facility and hospital visits as needed) in consultation with the specialty wound care team at St. Michael's Hospital.
Quantitative analyses will include data from: serial planimetry of wound digital photographs read by a blinded assessor (primary outcome), wound pain (VAS) and quality of life (EQ-5D), comprehensive case summary and referral tools and prospective resource utilization. Qualitative analyses will be carried out on a combination of testimony and field notes from: employee focus groups, individual interviews with facility leadership staff, ethnographic observations of team functioning and entries on an online forum.

Study Timeline

Baseline data collection began in October 2010. Phase 2 for all LTC facilities will end in March, 2012.
A final report will be prepared for September 2012.
Funded by the Ministry of Health and Long Term Care, the Canadian Patient Safety Institute, and the Central Community Care Access Centre. The clinical trial registration page is here.
 
 

Research Team

 
Anita Stern, RN, PhD
Murray Krahn, MD, MSc
Shabbir Alibhai, MD, MSc, FRCP(C)
Ross Baker,PhD
Connie Harris, RN, ET, IIWCC, MSc
Janice Hon, OT Reg (Ont), MCISt
Lianne Jeffs, RN, PhD
Matt Kowgier, MSc, PhD(c)
Les Levin, MB, MD, FRCP
Casey Li
Ann-Marie McLaren, DCh, BSc, MCISc
Linda Norton, OT Reg (Ont)
Mike Paulden, MSc, MA (Cantab.)
Ba' Pham, MSc, PhD(c)
Scott Reeves, PhD
Josie Santos, RN, MN
Laura Teague, RN, MScN, NP
George Tomlinson, PhD
Kevin Woo, RN, PhD
Gail Woodbury, PT, PhD
Merrick Zwarenstein, MBBCH, MSc, PhD
 
 

TURN Study (Turning for Ulcer ReductioN)

The purpose of this multi-site, randomized, controlled trial is to determine the most reasonably effective frequency of repositioning long term care (LTC) facility residents with mobility limitations who are at moderate and high risk for pressure ulcer development who are cared for on high density foam mattresses for the purpose of preventing pressure ulcers. In addition, the costs, the cost effectiveness, and the cost utility of various repositioning schedules for the prevention of pressure ulcers will be evaluated.
This study employs a 2 X 3 experimental design in which participants who are at two levels of risk for pressure ulcer development (moderate or high) are randomly assigned to one of 3 repositioning schedules (2, 3, or 4 hourly).
 

Inclusion Criteria:

  • Age 65 years or older and legally able to grant consent, or have an available surrogate who may legally grant consent.
  • At risk for pressure ulcer development with Braden Scale Scores of 10 to 14, indicating moderate (13-14) or high (10-12) risk.
  • Scores of 1 to 3 on the mobility subscale of the Braden Scale indicating some mobility limitations.
  • Expected to have a length of stay of 3 weeks for study participation.
  • Sleeping on a high density foam mattress
     

Exclusion Criteria:

  • Pressure ulcer(s) present on screening.
  • The resident cannot be turned on 3 anatomical surfaces (side, back, side) or has a contraindication to repositioning.
Participants will be studied prospectively for 3 weeks or until discharge from the LTC facility, whichever is earlier. Participants will wear an actigraph (a device that measures movement) during the second week of the intervention to determine if mobility is a covariate with repositioning frequency on pressure ulcer development, and to evaluate the integrity of the intervention. The primary outcome is the incidence and severity of pressure ulcers. Recruitment targets are 900 participants from the US, and 500 from Ontario.
 

Research Team

 
THETA staff is collaborating with investigators from the University of Texas (Dr. Nancy Bergstrom-PI, Dr. Mary Pat Rapp-co-investigator) and the Institute for Clinical Outcomes Research [ISIS-ICOR] (Dr. Susan Horn-co-PI) on this study.
 
 
Please visit http://son.uth.tmc.edu/coa/turn_overview.htm for more information.
 

Wound Interdisciplinary Teams (WIT)

Purpose

The purpose of this study is to evaluate the effectiveness and cost effectiveness of systematic referral to specialized multidisciplinary wound care teams (MDWCTs) in conjunction with comprehensive primary care delivery (Intervention group) vs. ‘usual care’ (Control group) for the treatment of community-based clients with chronic wounds in the Greater Toronto Area.

Research Question 

What is the clinical and cost-effectiveness of systematic referral to specialized MDWCTs in conjunction with comprehensive primary care delivery in contrast to ‘standard care’ for community-based patients with chronic wounds in the Greater Toronto Area?
 

Inclusion Criteria

  1. Newly referred to Toronto Central Community Care Access Centre (CCAC) for wound management.
  2. >18 years of age.
  3. Client or Substitute Decision Maker (SDM) provides written informed consent.
  4. Someone in the client’s home (or SDM) must be able to speak English.

Exclusion Criteria

  1. Surgical wounds.
  2. Burns.
  3. Malignant wounds.
  4. Clients deemed palliative.

Design and Methods

The study is a 2-arm pragmatic randomized controlled trial. Clients are referred to the study by case managers of Toronto Central CCAC. After informed consent, clients are randomized into Intervention or Control group. The Control group has ‘usual care’ as currently delivered to clients with chronic wounds in the community. Monthly digital wound photo is taken and monthly phone survey is conducted for 6 months (or until the wound heals, whichever comes first). For wounds that heal during that time, wound recurrence will be tracked for an additional 6 months. The Intervention group has, in addition, a specially trained wound care nurse to assess for systematic referral to multi-disciplinary wound care team at St. Michael's Hospital or Women's College Hospital. 
 

Study Timeline

The study started recruitment in May 2011. The target sample size was 450. Currently all data analyses are completed.
Dr. Murray Krahn gave the final presentation to the Ontario Health Technology Advisory Committee (OHTAC) on 24th May 2015. The preparation of the final manuscript iscomplete.
 
Abrahamyan L, Wong J, Pham B, Trubiani G, Carcone S, Mitsakakis N, Rosen L, Rac VE, Krahn M. Structure and characteristics of community-based multidisciplinary wound care teams in Ontario: An environmental scan. Wound Repair Regen. 2015 Jan-Feb;23(1):22-9.
 

Research Team

Murray Krahn, MD, MSc, FRCPC 
Valeria E. Rac, MD, PhD, Director, Clinical Research (Faculty) 
Josephine Wong, MD, MRCP(UK),

Funding

Health Quality Ontario

  • OUR PARTNERS
  • Leslie Dan Faculty of Pharmacy at the University of Toronto
  • Institute of Health Policy, Management and Evaluation (IHPME)
  • UHN - Toronto General Hospital
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