Using Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada

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1 Using Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada April 2009 Jack V. Tu, MD PhD FRCPC CANADA RESEARCH CHAIR IN HEALTH SERVICES RESEARCH Institute for Clinical Evaluative Sciences (ICES) Division of Cardiology, Schulich Heart Centre Sunnybrook Health Sciences Centre University of Toronto

2 Presenter Disclosure Information Jack V. Tu Using Clinical Registries To Create Evidencebased Health Care Policy FINANCIAL DISCLOSURE: NONE UNLABELED/UNAPPROVED USES DISCLOSURE: None

3 Outline Canadian healthcare system and clinical registries Examples of using clinical registries to create evidence-based health care policy in Ontario Challenges / conclusions

4

5

6 Canadian Health Care System - Overview Universal health care system = single payer model Health care is a provincial responsibility Physician and hospital services All citizens are covered for all medically necessary services (no co-payments or deductibles) Outpatient medications Elderly aged >65 are covered (with small co-payments) Non-elderly: private coverage or direct payment Funded predominantly through general tax revenues Per capita annual health expenditures - $3,000 US (10% of GDP, 2007)

7 Examples of clinical registries in Canada A number of well established, population-based clinical registries exist in Canada Cardiac Care Network (CCN) of Ontario Registry of the Canadian Stroke Network (RCSN) APPROACH cardiac procedures database ICONS ACS registry in Nova Scotia

8 Strengths of Canadian clinical registries Ability to cover 100% of the population (no selection biases) Ability to link to other population-based administrative databases via common unique identifier (via encrypted health card numbers) Regionalization of advanced tertiary cardiac services to a limited number of centers (PCI, CABG, etc.) Privacy legislation and officials that support clinical registries/research Governmental funding for several clinical registries

9 Linkable administrative databases in Canada Hospitalization and Emergency Room databases Drug Benefit databases Physician Claims databases Vital Statistics databases Laboratory databases

10 Advantages of working with policy makers on clinical registries Can mandate participation of providers/hospitals Provide access to publicly-funded administrative databases May provide stable long-term government funding vs. short-term, smaller peer-reviewed grant funding Provides researchers with academic freedom and independence in publishing results Interaction with policy makers allows researchers to understand the questions of interest to policy makers and design clinical registries to answer these questions

11 Examples of Clinical Registries that have led to evidence-based policy decisions in Ontario Privacy legislation and the Registry of the Canadian Stroke Network (RCSN) Drug Eluting Stent (DES) policy and the Cardiac Care Network (CCN) of Ontario

12 Tu et al. NEJM 350: , 2004

13 Registry of the Canadian Stroke Network Purpose: Monitor and improve the quality of stroke care in Canada Began in 2001, as a prospective registry involving 20 regional stroke centers in 8 provinces Designed in part to support evaluation of a government-funded $30 million Ontario stroke strategy Regional stroke centers (focus on tpa) Privacy landscape in Canada in a state of rapid flux Informed consent model selected due to Concern that patient consent would become mandatory per pending legislation Plan to contact patients following hospital discharge re quality of life Plan to share aggregate analyses of registry data with commercial organizations developing medications or aids for daily living

14 Registry of the Canadian Stroke Network Neurology research nurses at each site were trained to obtain informed consent, collect chart-based data and to conduct follow up interviews Study enrollment and data collection were hampered due to Difficulty obtaining consent from eligible patients Lengthy consent process (median=40 minutes) led to reduced time available for data collection Overall only 39% of eligible patients consented to participate in Phase 1 of the registry Despite a re-launching effort beginning in mid-2002, participation rate remained low at 51% in Phase 2

15 Reasons for non-participation Tu et al. NEJM 350: , 2004

16 Selection bias in enrolled participants Tu et al. NEJM 350: , 2004

17 Ontario PHIPA Privacy legislation (2004) The Personal Health Information Protection and Electronic Documents Act, subsequently passed in 2004, legislated Prescribed registries RCSN, CCN, similar to the cancer registry Prescribed entities ICES (high security data institutes where clinical and administrative databases can be linked together for research purposes) Information can be collected without informed consent, provided adequate privacy safeguards approved by the Privacy Commissioner were in place Patient notification was required (e.g. brochures, posters, web sites, etc)

18 N Engl J Med 2007; 357:

19 Drug Eluting Stent (DES) Policy in Ontario Background Drug-eluting stents (DES) introduced in Canada in 2002/2003 Cost ~ $3000 per stent vs. $600 for a bare-metal stent (BMS) A limited # of clinical trials suggested DES were most-effective in reducing restenosis in high-risk patients (e.g., diabetes, long lesions, small vessels) Ministry of Health (MOH) agreed to selectively fund DES for ~ 40% of all PCI cases Conditional upon all Ontario PCI hospitals participating in a provincial PCI stent clinical registry MOH commissioned a real-world analyses of cost and clinical effectiveness of DES to assist in setting provincial funding policy A collaborative initiative between Program for Assessment of Technologies in Health (PATH), Institute for Clinical Evaluative Sciences (ICES) and the Cardiac Care Network (CCN) of Ontario

20 Field Evaluation Studies OHTAC (Ontario Health Technology Assessment Committee) Funding for new devices conditional upon additional data collection (e.g. registry, RCT) Develop additional evidence to help policy makers make evidence-based resource allocation decisions Similar to concept of Coverage with Evidence Development (CED) CMS

21 DES Study Data Sources Cardiac Care Network of Ontario maintains a population-based clinical registry for all PCI procedures Demographics, clinical characteristics, comorbid conditions Stent type / size / length Lesion location / severity Linked to various administrative data sources to determine additional comorbidities and patient outcomes

22 Inclusion criteria DES Study Sample Began with 13,353 patients who underwent PCI in Ontario from Dec 1, 2003 and March 31, 2005 to provide at least 1 year of followup A propensity-score matched set (on 21 baseline characteristics) of 3751 pairs of patients used for the primary analysis

23 TARGET VESSEL REVASCULARIZATION (TVR) RATES TVR-free Survival (%) DES BMS p< % 10.7% Time following Index PCI (years) No. at Risk DES BMS

24 N Engl J Med 2007; 357:

25 N Engl J Med 2007; 357:

26 DES Study Conclusions Drug-eluting stents were most effective in reducing target-vessel revascularization among high-risk patients 2 or more risk factors (diabetes, small vessels, long lesions) No increased rate of death or myocardial infarction Data this study provided important evidence to support the government s long-term selective funding policy for DES

27 Challenges in using clinical registries to create evidence-based health care policies Competing timelines Policy makers may need data within days to weeks whereas research can take months to years Need to maintain ongoing relationships with policy makers who may frequently change due to elections, etc. Ongoing need to demonstrate utility and value of funding clinical registries vs. simply funding more health services Lobbying from stakeholders who may be adversely affected by research results

28 Conclusions Researchers and policy makers can work together to create evidence-based health care policies using clinical registries Policy makers can identify the key questions and provide funding to answer them Researchers can design and publish rigorous scientific studies to answer the questions confronting policy makers Collaboration between policy makers and researcher can help improve heath policy and the health care system

29 Thank you

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