Program
Program now available
Final Program [April 28 & 29]
Poster Presentations [April 27, 1700 - 1900]
Concurrent Sessions [April 28 & 29]
Session 1: April 28th -11:00 – 12:30
Effecting Real Change and Optimizing Drug Therapy—The Workplace Safety & Insurance Board Experience in Ontario
- The Workplace Safety & Insurance Board (WSIB) provides no-fault workplace insurance and manages about 350,000 claims annually. Health care benefit costs paid in 2006 increased to $494M from 2005 payments of $459M. In 2007, the drug expenditures for injured and ill workers were ~$80M. This drug plan has seen a steady rise in expenditures over the last decade, with a mean growth rate higher in comparison to drug expenditures overall in Canada (~9% per year, CIHI 2007). Detailed analyses revealed: vigorous adoption of new relatively expensive medications, expanded utilization of older therapies, increased polypharmacy, and concerns around safety and appropriate use of certain drug classes. This presentation will focus on a number of innovations that are having positive impacts on WSIB’s drug program including: initiation of a drug advisory committee, modification of formulary structure and management, specific analytic plans for certain drug classes, improved processes for pharmacologic and non-pharmacologic management of common clinical problems (e.g., pain), a highly responsive information platform to provide up-to-date utilization data, and, finally, commitment to observational and interventional studies—all of these are contributing to optimizing drug use and enhancing patient outcomes.
- [Session 1, April 28, 1100 – 1230, Paul Oh, Donna Bain]
Improving Access to Quality Drug Therapy through an Expanded Role for Pharmacists
- Effective April 1, 2007, Alberta pharmacists were authorized through legislation to prescribe drugs.
- The Alberta College of Pharmacists (ACP) developed a unique model that defines pharmacist prescribing, and which is reflected in the regulatory framework. Authority for pharmacists to prescribe responds to the six criteria for quality identified in the Health Quality Council of Alberta’s, “Health Quality Matrix”. Most prescribing will be conducted in a collaborative environment; however, the regulations recognize that some patients will benefit from the ability of pharmacists to prescribe when they are the “initial point of contact” for care.
- The privilege to prescribe is a new tool that will be used by some pharmacists, in some situations, to resolve drug-related problems. Basic privileges have been provided to all pharmacists on ACP’s clinical (practicing) register. Additional privileges are being granted to pharmacists who successfully complete an evaluation process administered by ACP.
- This presentation will introduce the prescribing model, ACP’s implementation strategy including the evaluation process for “additional prescribing” privileges, and share observations from the College’s implementation experience.
[Session 1, April 28, 1100 – 1230, Greg Eberhart]
The National Prescription Drug Utilization Information System (NPDUIS) Database: Information to Support Policy Development and Impact Measurement
- The National Prescription Drug Utilization Information System (NPDUIS) database provides comprehensive and comparable information on drug claims from public drug programs. The database, launched in 2006, contains claims-level prescription data from six provinces, as well as pan-Canadian formulary coverage. The NPDUIS database provides supporting documentation on high-level program policies to inform on analyses conducted. The primary users of NPDUIS information to date have been the public drug plans, as well as health and research-related organizations. Analyses using NPDUIS data have several applications. Drug plan managers use comparative information to examine/observe changes in drug utilization patterns, and to inform program policy changes and formulary design decisions. Analyses can also be used to examine topics such as persistency with drug therapy, as well as the impact of new evidence, clinical practice guidelines, and optimal prescribing initiatives (e.g., academic detailing) on drug utilization trends. The Canadian Institute for Health Information’s first published analytic report using NPDUIS data looked at claim patterns in seniors for drugs on the Beers List, an international list of drugs identified as potentially inappropriate to prescribe to seniors. Future CIHI reports will include topics of interest to F/P/T Drug Programs, as well as inform on the health of Canadians. [Session 1, April 28, 1100 – 1230, Mike Gaucher]
Session 2: April 28th -11:00 – 12:30
Re-use of single-use medical devices in Canada: Using Evidence to Inform Policy
- The reuse of single-use medical devices (SUDs) after reprocessing has become a common practice in some Canadian hospitals because of perceived economic benefits, but the practice remains controversial. There are concerns about possible risks to patients, cost-effectiveness of SUD reprocessing, and policy implications. This session will address these issues through a multi-disciplinary panel providing input on current practices and clinical evidence, economic issues, and implications for hospitals and health policy.
- [Session 2, April 28, 2008, Hussein Noorani, Philip Jacobs, Sudha Kutty, Philip Neufeld, Julie Polisena]
Session 3: April 28th -11:00 – 12:30
One World, One Evidence-base, Many Decisions: Bevacizumab for the Treatment of Metastatic Colorectal Cancer
- Advances in the treatment of cancer are often step-wise with modest gains in survival. The cost of these treatments can be a daunting challenge for funding bodies. Bevacizumab for the treatment of metastatic colorectal cancer represents an important example of the challenge faced by decision makers funding oncology medications. Bevacizumab is associated with a two- to five-month improvement in survival. Cost-effectiveness analysis suggests that bevacizumab likely exceeds traditionally accepted thresholds. In addition, because colon cancer is relatively common it can be expected to have a major budget impact. Approximately 100 patients per million of the population will require treatment at a cost of $3 million to $4 million, per million of the population. Evidence of survival benefits, combined with the economic analysis of cost- effectiveness and budget impact, leave decision makers with difficult challenges in the area beyond the evidence. The varying decisions across Canada and the approach taken in the US and the UK will be explored. From full public coverage to capped coverage, no coverage and private third-party arrangements, bevacizumab funding involves difficult and politically sensitive decisions for funding bodies around the world. These are interesting times, where tough decisions involve evidence, economics, and an ethics of fairness that balances the needs of the individual and our society. [Session 3, April 28, 1100 – 1230, Shawn Budgen]
Hospital Information and Communication Technology (ICT) Investments: Rational Choice or Rock, Paper, Scissors?
- Hospital capital investments in technology: rational choice or rock, paper, scissors? Spending in health care in Canada reached $148 billion in 2006. Medical technologies (including both medical devices and information technologies) represent a vital component of this spending as these investments contribute directly to outcomes such as improved patient safety and high- quality care. With the widespread acceptance of “show me the data” evidence-based approaches to evaluating the merits of many medical technologies, one might expect investment decision making processes to be equally well developed. Interestingly, while sophisticated approaches to evaluate capital investment decisions exist, these approaches may not be widely used when making vital decisions about investments in medical technologies. Furthermore, while we can often answer the question “Does this technology work?,” we’re not helping managers answer the question. With limited resources, is this the right choice for us? This presentation explores this dichotomy. Insights into current investment decision practices are offered, together with thoughts on how the experience gained in evaluating the merits of medical devices could be applied to other medical technologies like information technologies. [Session 3, April 28, 1100 – 1230, Josephine McMurray, Ian McKillop]
A Tri-Nation Comparison of Pharmacoeconomic Submissions
- Background: The Common Drug Review (CDR) was established in Canada to provide formulary listing recommendations to the participating public drug plans. Although set up with differing mandates, the National Institute for Clinical and Health Excellence (NICE) in the United Kingdom and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia appear to have similar roles.
- Objective: To compare the submissions received by each committee, and describe the similarities and differences among review processes and recommendations made.
- Methods: Through the public access web site maintained by each committee, a list of each submission considered was compiled. Data were collected from the implementation of publicly accessible information to December 31, 2007 (NICE—Feb. 2001, CDR—Jan. 2003, and PBAC—July 2005). Each drug submission for a unique indication was considered a separate submission.
- Results: NICE has reviewed 145 unique drug/indication combinations, while CDR and PBAC have each reviewed 80 and 157 drug/indication combinations, respectively. Ten unique drug/indication combinations were assessed by all three committees, with six being assessed by both CDR and NICE, 25 by NICE and PBAC, and 24 by CDR and PBAC. The reasons for these differences are explored.
- Conclusions: There is very little overlap in the drug submissions considered by each committee, which may relate to differences in mandate of the different bodies.
- [Session 3, April 29, 1100 – 1230, Fiona Clement]
Session 4: April 28th -11:00 – 12:30
Networks for the Production and Use of HTA
- This session will provide an update on the HTS Policy Forum and Exchange and Alberta’s new HTA Network [Session 4, April 28, 1100 – 1230]
Session 5: April 28th -11:00 – 12:30
Cost-Effectiveness of Therapy with Combinations of Long-Acting Bronchodilators and Inhaled Steroids for Treatment of COPD: An Economic Evaluation of the OPTIMAL Study
- Background: Little is known about the combination of different classes of medications in chronic obstructive pulmonary disease (COPD). It is hypothesized that drugs with a different mechanism of action might have additive or even synergistic effects. This study determined the cost-effectiveness of adding salmeterol (S) or fluticasone/salmeterol (FS) to tiotropium (T) for COPD.
- Methods: This concurrent, prospective economic analysis was based on data (costs and health outcomes) from a randomized, placebo-controlled study comparing three treatments 1: tiotropium+placebo (TP group), 2: tiotropium+salmeterol (TS group), and 3: tiotropium+fluticasone/salmeterol (TFS group). Patients were randomly assigned to the treatments for 52 weeks. The incremental cost per exacerbation avoided and per additional quality-adjusted life year (QALY) were used as outcomes.
- Results: The TS strategy was dominated by TP and TFS. Compared with TP, the TFS strategy resulted in ICERs of $6,510 per exacerbation avoided and $243,180 per QALY gained.
- Conclusions: Patients treated with TFS had a significantly better quality of life and fewer hospitalizations than patients treated with TP; however, these improvements in health outcomes were associated with increased costs. Neither TFS nor TS are cost-effective alternatives for monotherapy with T. [Session 5, April 28, 1100 – 1230, Mohsen Sadatsafavi]
NPDUIS Drug Trend Report, 2005/06
- Since the mid-1990’s, drug expenditure in Canada has been rising rapidly due to numerous, complex reasons including: increased utilization; shifts to newer, more expensive drugs in a few therapeutic classes; population aging; and other factors. With this milieu as a backdrop, Federal/Provincial and Territorial Ministers of Health announced the establishment of the National Prescription Drug Utilization Information System (NPDUIS) in 2001. As set out by the Ministers, the purpose of NPDUIS is to provide critical, comprehensive analysis of drug trend using data provided by public drug plans across Canada. The NPDUIS Drug Trend Report, 2005/06 is one of the main outputs of the NPDUIS initiative. It presents high-level drug trend results for expenditure and claimant populations and other aspects of expenditure change related to: market segments (patent, non-patent, and generic), therapeutic class, price, utilization, cost drivers, and comparative statistics on drug formularies. One of the key highlights of the report is that expenditure increased by 8.9% in 2005/06—part of a five-year trend in which growth has gradually declined from a high of 13.6% in 2001/02. The ten drug plans that participated in this NPDUIS report spent a total of $5.85 billion in 2005/06, up from $5.37 billion a year earlier, and $3.93 billion in 2001/02. (These expenditures refer to government share. In most jurisdictions, patients also pay a portion of a drug claim as a co-pay or deductible.) [Session 5, April 28, 1100 – 1230, Greg McComb]
Achieving Rigour and Relevance in a Health Technology Assessment (HTA) of Double Balloon Endoscopy
- Double balloon endoscopy/ enteroscopy (DBE) provides access to the inner surface of the small intestine for visual examination, biopsy, and treatment. This represents new medical capability unmatched by existing nonsurgical modalities. Still, there is reasonable doubt that DBE is the breakthrough technology it appears to be. The available research data on health outcomes is largely from uncontrolled case series low on standard hierarchies of evidence and, therefore, providing little protection against bias. The policy-relevant and definitive controlled trial may never be done, in part due to the heterogeneity of indications, final diagnoses and therapeutic maneuvers. Identifying the select and heterogeneous group of patients representing those that could most benefit from DBE in administrative datasets is difficult yet fundamental to accurately estimating cost impact. A narrowly focused systematic review question, while preferable for achieving scientific validity and generalizability, may omit or discount evidence on important impacts and resource implications. The full capabilities of DBE are likely to be used if DBE were to become a publicly funded service in Alberta. A broad focus encompassing nineteen interrelated research questions was therefore used in an HTA strategy undertaken to review all available evidence on the social, fiscal, and economic impact of DBE.
[Session 5, April 28, 1100 – 1230, Carolyn Green]
Session 6: April 28th - 15:30 – 17:00
Following the Evidence Road: Implementation of Evidence-Based Decisions for Personal Care Home Formularies
- Evidence-based review of medications is a pivotal component of formulary decisions. This review of evidence has played an important role in decisions around the coverage and management of cholinesterase inhibitors in the treatment of Alzheimer’s disease for residents of personal care homes (PCHs) in Manitoba. This process is supported by the work of the Canadian Agency for Drugs and Technologies in Health (CADTH), through the production of systematic reviews and region-based workshops that focus on the use of these tools.
- The evidence suggests some real limitations to the efficacy of cholinesterase inhibitors. Both clinical and economic analysis suggests that careful clinical evaluation is needed to ensure that these medications are reserved for patients for whom there has been a demonstrated benefit. This presentation will review this evidence and provide the background that supports the current approach to management of cholinesterase inhibitors in the PCHs of Manitoba.
- However, evidence-based clinical review is not the end of the road for evidence-based medicine. Implementation issues and consideration of ethics and fairness may present challenges for decision makers. The presentation will explore the hazy area of ethics that extends beyond clinical evaluation as it applies to the management of cholinesterase inhibitors in Manitoba’s PCH setting.
- [Session 6, April 28, Shawn Budgen, Donna Champagne, Penny Murray]
Session 7: April 28th - 15:30 – 17:00
The Methodological Conundrum of Guideline Adaptation: How to Align Evidence Quality with Recommendations
- The strength and quality of evidence used to formulate practice guidelines is usually encapsulated by formally defined terms such as good, fair, poor, insufficient, or conflicting, which then determine the strength and type of recommendations made (do, don’t do, don’t know, no effect, conflicting/insufficient). However, when adapting existing seed guidelines, the quality of the underlying empirical evidence is not assessed, and these terms cannot be formally defined, leading to a significant methodological conundrum. The Alberta HTA Chronic Pain Ambassador Program used the AGREE tool to identify the best quality guidelines on low back pain management, from which a multidisciplinary committee constructed Alberta-specific guidelines. Although seven average-to-good quality guidelines were found, the AGREE tool could not verify the validity of the recommendations and the underlying evidence or reconcile differences in evidence-rating scales. In many cases, additional evidence was required, particularly when recommendations were overlapping, discordant, or absent. Committee subgroups interpreted the additional information, and a process was developed to systematically translate this subjective process into valid, consistently worded recommendations. The lack of sophisticated evidence analysis inherent in guideline adaptation can be overcome with credible seed guidelines; a consistent, transparent methodology; and clear documentation of the often subjective contextualization process.
[Session 7, April 28, Ann Scott, Christa Harstall, Carmen Moga, Paul Taenzer]
Session 8: April 28th - 15:30 – 17:00
Application of Evidence-based Knowledge: Collaboration between Academic Detailers and Primary Care Pharmacists
- The Calgary Rural Primary Care Network Pharmacist Integration Initiative (CRPCN-PII) collaborated with Academic Detailing—Calgary Health Region (AD-CHR) to: (a) promote clinical decision-making consistent with scientific evidence; (b) facilitate practice change in community-based physician offices; and (c) work jointly with local pharmacist colleagues.
- This project focused on improving the health of patients receiving acid suppressive therapy through proton pump inhibitors (PPI). As well, the feasibility of collaboration was explored, considering limited resources.
- AD-CHR compiled literature for CRPCN-PII to review in preparation for detailing sessions. All participated in a workshop, and a post-detailing project was planned to translate knowledge into changes in prescribing (reduce the number of patients unnecessarily receiving double-dose PPI therapy).
- The CRPCN-PII pharmacists spent 9% of their time related to this detailing project. Eighteen family physicians (24%) within the CRPCN received detailing from AD-CHR, compared to 1 (1%) in a previous topic and, overall, physician participation increased 20%. X% patients were successfully tapered from double-dose PPI therapy to standard dose.
- Collaboratively, the CRPCN-PII provided an evidence-based, focused service to physicians, and AD-CHR expanded the reach of their program. Both programs increased their scope by designing a knowledge translation project to benefit patient care in alignment with scientific evidence. [Session 8, April 28, 1530 – 1700, Kaye Andrews, Debbie Bunka]
- “Citizen Science”: A Transformative Way of Engaging Consumers & Decision Makers
- When individuals become patients, they also become key information sources which health professionals and decision makers should be accessing. Patients should be meaningfully involved in their health care and treatment decisions, including drug prescription. Even more critical for decision makers is making tough decisions about drugs and other health products based on inadequate evidence at the time. Is there ever adequate, convincing evidence about any drug or health product regarding safety, effectiveness, and efficacy before it is prescribed and used? Can patients be more appropriately utilized in providing the missing real world evidence about drugs, and proactively reporting adverse reactions and side effects? There is much to be gained, and very little to lose, from this knowledge exchange between decision makers and patients. Decision makers gain unique evidence, and patients/consumers benefit from being actively engaged in their own treatment and learning about optimal and safe drug or health product use. This type of knowledge exchange and evidence is “citizen science”. Evidence supports “citizen science” and raises the standards for the way in which patients are viewed in knowledge exchange, decision making, and health care reform. If patients/consumers are part of the process, they are also part of the solution!
- [Session 8, April 28, 1530 – 1700, Katharina Kovacs Burns]
Rx for Change Interventions Database
- Introduction: This presentation demonstrates the Rx for Change interventions database, developed by the Canadian Agency for Drugs and Technologies in Health through its Canadian Optimal Medication Prescribing and Utilization Service. This first-in-class, publicly accessible interventions database provides easy access to current research evidence about the effectiveness of strategies and programs to improve drug prescribing and use. This Internet-based tool is particularly relevant to policy makers and interventionists interested in seeking to affect change in prescribing and utilization behaviour among front-line health care providers.
- Methods: Systematic reviews targeting professionals, and financial, structural and organizational strategies, are defined and organized according to the intervention classification scheme of the Effective Practice and Organisation of Care (EPOC) Review Group. Reviews targeting consumers are defined and organized according to a unique scheme developed by the Cochrane Consumers and Communication Review Group.
- Results: This database provides access to current research evidence about the effectiveness of strategies and programs to improve drug prescribing and use.
- Conclusion: The Rx for Change database supports health care providers and decision makers in finding reliable, up-to-date, evidence-based information on drug prescribing and use behaviour. This resource was developed to assist in the selection of behaviour-change strategies that promote the optimal use of medicines.
- [Session 8, April 28, 1530 – 1700, Bill Leslie]
- Session 9: April 28th - 15:30 – 17:00
Newfoundland’s Contextualized Health Research Synthesis Program: An Innovative Collaborative Approach to HTA Synthesis for Policy Makers
- The objective of the Contextualized Health Research Synthesis Program is to support evidence-informed decision making in health technology by providing high-quality syntheses of health technology assessment (HTA) evidence on topics that are important to the provincial health system while contextualizing the results so that they are attuned to the characteristics and capacities of the local health system and population. The methodology involves partnering with key health decision makers to identify and prioritize topics of importance to the health system. For each chosen topic, a research team is formed, including a senior scientist with expertise in the specific new technology; a senior health system representative; local and external scientific experts, including a health economist; and experts in systematic reviews and HTAs. Each topic is formulated as a research question susceptible to HTA. The team then finds recent HTAs on the question, synthesizes the evidence, and contextualizes the results to the requirements and resources of the province. An external reviewer validates the report which is then disseminated to health decision makers in formats designed to maximize their uptake. Preliminary feedback from stakeholders supports the conclusion that this innovative contextualized approach provides helpful and usable evidence for decision makers considering difficult technology choices in unique health systems.
- [Session 9, April 28, 1530 – 1700, Stephen Bornstein, Janice Butler]
Evidence and Value: Impact on DEcisionMaking (EVIDEM)—A Practical Framework Applying Multi-criteria Decision Analysis (MCDA) to Support Health Care Decision Making
- Objectives: Develop a practical and quantitative methodology to structure and facilitate health care decision making.
- Methodology: A conceptual framework was developed that segregated components of decision making into three: 1) quality of evidence available; 2) intrinsic value of the health care intervention; and 3) extrinsic or system-related value. Using this framework, practical tools to assess health care interventions were designed, drawing on current decision-making processes for drug reimbursement globally and an extensive review of the literature.
- Results: A Quality Matrix was designed to quantify the quality of evidence available for an intervention; five elements defining quality were clustered by three criteria and 12 components covering the range of evidence required for decision making. Scoring was based on international standards in each discipline. To quantify the intrinsic value of an intervention, a multi-criteria decision analysis (MCDA) matrix (Value Matrix) was designed, encompassing 15 key value components. Scoring allows inclusion of the perspectives and weighted values of representative health care stakeholders. An integrated process to apply matrices was established, and early testing is ongoing with Canadian stakeholders.
- Conclusions: The EVIDEM methodology is a practical collaborative framework that can be applied to assess quality of evidence, define explicit data needs, and support health care decision making. [Session 9, April 28, 1530 – 1700, Mireille Goetghebeur]
- Implementation of the GRADE Method for Developing Recommendations on the Use of Insulin Analogues for the Management of Diabetes Mellitus
- Introduction: This presentation demonstrates how the Canadian Agency for Drugs and Technologies in Health, through its Canadian Optimal Medication Prescribing and Utilization Service, implemented the GRADE approach for developing recommendations on the use of insulin analogues in the management of diabetes mellitus (DM).
- Methods: Outcomes relevant to prescribing decisions for treatment of DM were identified and ranked by an expert panel. Unique GRADE Evidence Profiles were developed for each treatment comparison and specific patient population. Each Profile presented meta-analytic estimates of effect size for identified outcomes and, where data permitted, the results of pharmacoeconomic analyses. Quality and internal and external validity of the evidence was assessed. Recommendations were developed, and the strength of each was determined.
- Results: Thirty-two outcomes were identified as relevant to making prescribing decisions. Estimates of effect size for outcomes, by treatment comparison, were derived from 94 meta-analyses. Thirty-three Profiles were produced from which twenty-seven recommendations were generated.
- Conclusion: The use of this approach presented unique challenges, including incorporating evidence from single studies and integrating resource utilization data. GRADE provides a systematic process to identify, analyze, and present a large body of evidence, and a transparent methodological approach for the development of evidence-based optimal therapy recommendations. [Session 9, April 28, 1530 – 1700. Heather Bennett]
Session 10: April 28th - 15:30 – 17:00
CEDAC Recommendations: Does Cost-Effectiveness Matter?
- Objectives: The Canadian Expert Drug Advisory Committee (CEDAC) is explicitly charged to consider cost-effectiveness in its mandate. Reasons for Recommendations were reviewed to determine how cost-effectiveness information was used.
- Methods: Reasons for Recommendations were identified from inception (September 2003) to October 2007. Each unique recommendation was categorized as follows: cost-effectiveness was mentioned in the Reasons, incremental cost-effectiveness ratios (ICERs) were considered attractive, and the listing recommendation. ICERs were designated as attractive based on direct comments in the Reasons or indirectly through the restrictiveness of the recommended criteria.
- Results: There were 78 unique recommendations. Cost-effectiveness was mentioned in 45% of recommendations (N=34). The ICER was considered attractive for 15% of drugs (N=5); these had positive listing recommendations. Economically unattractive drugs with positive recommendations had an ICER range (where stated) from $50K to $80K/quality-adjusted life-years (QALY). Economically unattractive drugs with negative recommendations had an ICER range from $18K to $189K/QALY.
- Conclusions: Cost-effectiveness was often not mentioned in CEDAC recommendations. There appeared to be a threshold of $50K/QALY with a grey zone extending up to $80K/QALY. However, many drugs were not recommended. Overall, economic information had a limited role for informing Canadian drug reimbursement recommendations.
- [Session 10, April 28, 1530 – 1700, Angela Rocchi]
Common Drug Review (CDR) Transparency Initiatives
- CADTH’s Common Drug Review (CDR) program reviews the clinical and cost effectiveness of drugs, and its Canadian Expert Drug Advisory Committee (CEDAC) provides formulary listing recommendations to publicly funded drug plans. A one- to two-page summary of each CEDAC recommendation and the reasons for recommendation is published by CADTH. While these summaries provide some insight into the key considerations behind a recommendation, they do not contain all of the information considered by CEDAC. In response to requests for more information from stakeholders, CADTH is taking steps to further enhance the transparency of the CDR to improve understanding of the reasons for CDR recommendations.
Starting with drug submissions considered at the April 2008 CEDAC meeting, CADTH will publish:
- a 20-25 page overview of the CDR clinical and pharmacoeconomic review reports
- a summary of CEDAC’s discussion relating to the drug
- a plain language version of the final recommendation and reasons for recommendation.
- To date, there has been limited transparency in drug reviews for regulatory approval and reimbursement in Canada. Increased transparency, which will require the cooperative efforts of researchers, manufacturers and governments, should create more confidence in the decision-making process. [Session 10, April 28, 1530 – 1700, Braden Manns]
Common Drug Review Case Studies that Challenge The Canadian Agency for Drugs and Technologies in Health’s Reputation
- The Canadian Agency for Drugs and Technologies in Health works with evidence-based choices in the use of health technologies. There are three initiatives: Health Technology Assessment, Common Drug Review (CDR), and the Canadian Optimal Medication Prescribing and Utilization Service. In the CDR process, reviewers’ comments and manufacturers’ submissions are appraised by the Canadian Expert Drug Advisory Committee (CEDAC). This presentation refers to four recent CEDAC reports, available on the Internet, released between October and December 2007, and examines them in light of previous recommendations. For each one, the context, results of effectiveness analysis, cost analysis, recommendation, and reasons for reconsideration are presented. A list of problems is identified at the end for each one. A list of recommendations for the future is presented at the end of the four reviews.
- These four cases show how the lack of transparency, the lack of stakeholders’ input, and the lack of coherence can affect the credibility of the assessments.
[Session 10, April 28, 1530 – 1700, David Rumel]
Session 11: April 29th - 10:30 – 12:00
From Evidence to Policy to Implementation to Behavioural Change
- This panel presentation will outline an example of products and services developed by a pan-Canadian agency and used by provincial policy makers and educators to promote evidence-based prescribing. The objective is to stimulate discussion on developing other models. The Canadian Agency for Drugs and Technologies in Health’s (CADTH’s) Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) developed evidence-based key messages on the use of proton pump inhibitors (PPIs) through an extensive review of guidelines, systematic reviews, and primary publications. COMPUS worked with the Canadian Academic Detailing Collaboration to develop intervention tools promoting optimal prescribing of PPIs. The CADTH Liaison Officer program and COMPUS promoted and supported implementation of the PPI key messages and tools. The evidence on PPIs led to policy changes in Nova Scotia. The Drug Evaluation Alliance of Nova Scotia, which funds and coordinates best practice activities for NS Pharmacare, is working with the CADTH Liaison Officer program, COMPUS, and Nova Scotia’s Academic Detailing Service. Together, they are developing and implementing several educational interventions, including academic detailing and pharmacist and nurse education, to encourage prescribing and use of PPIs that reflects recent policy changes. Panelists will summarize their role in this collaborative effort, and the moderator will lead discussion on lessons learned and opportunities to apply the learnings in other settings and jurisdictions. [Session 11, April 29, 1030 – 1200, Denis Bélanger, Michael Allen, Lisa Farrell, Dawn Frail, Bill Leslie, Sandra Rees]
Session 12: April 29th - 10:30 – 12:00 (Some presentations in this concurrent session will be made in French – Simultaneous interpretation will be provided)
- The Organizational Model of the Technology and Health Intervention Methods Evaluation Unit at the Centre Hospitalier Universitaire de Québec: An Innovative Approach to Shared, Evidence-Based Decision Making
- To promote the evaluation of health technologies and intervention methods, in compliance with strategic guidance from the CHUQ and in line with the missions of university hospitals, the CHUQ decided in 2006 to launch UETMIS, its Technology and Health Intervention Methods Evaluation Unit (Unité d’évaluation des technologies et des modes d’intervention en santé).
- To assist senior staff, clinical practitioners and health professionals to make decisions pertaining to the launch of a new technology or clinical practice, UETMIS has applied a structured evaluation method that favours strong involvement from the main persons involved, at every stage of the process. Our objective is to present the method used by the CHUQ for shared decision making at UETMIS between senior staff and clinical practitioners by illustrating one specific example involving the administration of contrast agents in medical imaging. Against a background of divided opinions as to the risks related to current practice and the necessary changes to be made, sharing evidence-based information united clinical teams when choosing the best possible decision to be made for patient safety. Moreover, this information was factored into senior management’s new policy regarding the reprocessing of single-use medical devices. [Session 12, April 29, 1030 – 1100, Chantale Simard, Marc Rhainds]
Revision of a Local Health Technology Assessment Program by Departments within the Calgary Health Region
- Many local decision makers do not have consistent and transparent mechanisms in place to capture, integrate, and report on the clinical, administrative, and financial aspects of introducing a new health technology into their local environment. To address this need, we first developed a draft Local Health Technology Assessment (HTA) Program in conjunction with the Department of Surgery and Surgical Services within the Calgary Health Region (CHR). The present project engaged additional departments within the CHR, who reviewed and tested the draft Local HTA Program and provided feedback for its revision. Outcomes included: 1) participation of ten departments in the testing and feedback process; 2) revision of the Local HTA Program to create two major pathways for evaluating new technology: a rapid “Request” pathway for minor changes of practice and a more extensive “Local HTA” pathway for when there are uncertainties about a technology’s impact on clinical outcomes, resources, or finances; and 3) identification of issues inadequately addressed by the current Local HTA Program, such as clear definitions of “minor” versus “significant” change in practice; processes for urgent/emergent, compassionate, and one-off requests; and a process for replacing ageing technology. The revised program provides a critical tool to facilitate the assessment of technology by local administrators. [Session 12, April 29, 1030 – 1100, Paule Poulin]
The Launch of a Demonstration-based Technology Evaluation Unit
- The Montréal Heart Institute is setting up a technology evaluation unit in order to fulfil its academic mission. We have adopted a bottom-to-top approach stemming from biomedical engineering, with the aim of raising the awareness of our management team with regard to this new culture. It was not presented as a control procedure, but rather as a decision-making and innovation support mechanism. After reaching a preliminary agreement with management, we began by performing targeted analyses of medical equipment. We realized how important and difficult it was to rigorously collect evidence. Moreover, the technology under evaluation is recent and thus has a less significant impact on medical practices than past innovations. We recognised that we are on the boundary between clinical research and current medical practice and that our organizations are potentially bearing the costs related to research activities. Hence, we believe that technology evaluation is as strategic as it is scientific. We are aware that our technology evaluation unit has room for improvement, particularly in terms of our methodology. Nevertheless, it has been able to influence management’s decision making, even though it is just getting off the ground.
- [Session 12, April 29, 1530 – 12700, Yves Amyot, Sophie LeBail]
Session 13: April 29th - 10:30 – 12:00
A Question of Balance: HTA versus Innovation
- The diffusion of health technology is often driven by marketing experts, for which health technology assessment (HTA) provides a restraining force to the spread of ineffective technology. Decisions about which medical technologies to adopt and use are crucial to the quality, affordability, and sustainability of health care. In contrast to the tenets of HTA, innovation most often requires the implementation of unproven technology. Although “sustainability” is often used as a synonym for cost control and, by extension, for curtailing the diffusion of unproven technologies, the pipeline of technology advancement must also be sustained.
- There has been relatively little attention paid to determining which policies and practices can achieve the optimal balance between the opposing forces of restraint and innovation in the diffusion of health technology in a publicly-funded health care system. This presentation will review several strategies that have been implemented in different contexts (e.g., federal, provincial, and regional) that attempt to balance the restraining influence of traditional HTA with the expansive force of technology development. An underlying theme of this presentation is that, while HTA is critical to making the best choices among different options, the HTA community should also address the need to nurture the systems that provide those options. [Session 13, April 29, 1030 – 1200, Janet Joy, Melanie Leung]
Bridging Genomics and Therapy—Creating a Theranostics Paradigm
- Despite the enormous effort and billions of dollars that have gone into the development of cancer therapies, the benefits of such therapies are limited to a small proportion of cancer patients. Unfortunately, there is no reliable way of identifying favourable subsets of patients using current methods. Patient selection for specific treatments is largely based on average criteria. For instance, a large number of breast cancer patients with low risk stage I disease receive unnecessary chemotherapy or radiation therapy in order to benefit a small fraction of such patients. The global impact of unnecessary therapy for breast cancer alone will reach almost $30 billion dollars in 10 years. If we are going to improve the management of cancer, a more sophisticated, biologically and clinically relevant predictive classification system is required. For the top five cancers (lung, breast, colorectal, prostate, and lymphoma), the need for rational, personalized treatment selection, called Theranostics, is urgent, not only because of the economic impact, but also because outcomes could be dramatically improved. Examples to illustrate this paradigm shift will be presented.
- [Session 13, April 28, 1030 – 1200, Diponkar Banerjee]
The New Drug Pipeline Monitor: A New Phase for the National Prescription Drug Utilization Information System (NPDUIS)
- The New Drug Pipeline Monitor (NDPM) is a product of the National Prescription Drug Utilization Information System (NPDUIS) and represents an innovative publication that highlights pipeline drugs in development. It synthesizes data from numerous sources, including the BioPharm Insight database, company projections, government publications, and academic papers. Government policy-makers can use the information provided to aid in making tough reimbursement decisions. The inaugural edition of the NDPM (Summer 2007) received global attention as a new tool that identifies emerging drug therapies with the potential to impact course of treatment and public drug budgets three to five years down the road. The second edition (Spring 2008) has evolved into a broader publication that updates the drug list and provides an emphasis on a specific class of emerging drugs in a major treatment area such as cancer. The NDPM is developing an Internet-based tool that will allow users to access the most current information available, and download selected records. This presentation will include an overview of the published NDPM, as well as additional updates included in the yet-to-be- released Spring 2008 edition. As the Monitor grows and develops, it will provide valuable information to policy makers at all levels of government.
- [Session 13, April 29, 1030 – 1200, Rebecca Szilagyi]
Session 14: April 29th - 10:30 – 12:00
When Evidence Is Not Enough: Involving the Public in the Priority-Setting of a Wait Time Management Initiative to Enhance Legitimacy and Fairness
- Often scientific analysis is insufficient as a means to set priorities. Priority setting (PS) is not only a technical exercise, but is value-laden. The public embody societal values and are experts in identifying and adjudicating between subjective values inherent in PS. The purpose of this research is to determine how to involve the public in a wait time strategy PS initiative. We describe and evaluate the Ontario Wait Time Strategy (OWTS) PS including views of OWTS stakeholders on why, how, and where the public can be involved. Two studies were conducted: 1) a qualitative case study to describe and evaluate PS of OWTS; PS was evaluated using a leading conceptual framework for fair PS; 2) telephone interviews with a population of Ontarians to describe views on public involvement and PS at OWTS. Interviews with OWTS officials reveal minimal involvement of the public. Stakeholders propose there is much opportunity to involve the public in OWTS PS. Interviews with citizens suggest support for public involvement in OWTS. The public can be involved through: 1) shared decision making, 2) focused outreach, and 3) feedback and appeals. Increased public engagement in OWTS will enhance the legitimacy and fairness of the strategy while bolstering its sustainability.
- [Session 14, April 29, 1030 – 1200, Rebecca Bruni]
Evaluating Success in Priority Setting
- Currently, there is little information or guidance for decision makers to engage in successful priority setting (PS); this research attempts to fill this gap.
- Purpose: To answer this question: How can we evaluate success in PS? Step 1) define success from the stakeholders’ point of view. Step 2) create and pilot test an evaluation tool.
- Methods:
- (1) Three qualitative methods: interviews with Canadian decision makers; focus groups with a national representation of patients/caregivers and policy makers; Delphi study including international scholars and decision makers.
- (2) Pilot study to test the tool
- Results: We first describe stakeholders’ views about successful PS through a conceptual framework which has 10 elements. Second, we describe the development and pilot test of the evaluation tool. The framework and tool can be used by decision makers to evaluate PS activities (budgeting, strategic planning) by identifying areas of success and opportunities for improvement.
- Conclusions: Decision-makers can find guidance in setting priorities through the conceptual
- framework and evaluation tool. The framework and tool contain both procedural and substantive goals of PS, and specify both quantitative and qualitative dimensions. To our knowledge, this is the first comprehensive framework describing successful PS. By evaluating success in PS, we take steps toward improving it.
[Session 14, April 29, 1030 – 1200, Shannon Sibbald]
Using Evidence in Resource Allocation Decisions: Empirical Studies from British Columbia’s Health Authorities
- We propose to report on several related projects that, together, advance an overall research agenda related to evidence-informed health care priority setting. The findings are drawn from our experiences since 2004 working with BC health authorities in a wide range of service areas, and from a substantial scoping review of the published and grey literatures on public engagement in priority setting.
- Workshops/Forums, qualitative interviews and interventions with decision makers in all six of BC’s health authorities provide insight into their perspectives on evidence: how they have used evidence in the past, do presently, and wish they could use it to improve priority setting and resource allocation. We discuss facilitators and barriers to evidence use by health care leaders, particularly in decommissioning or dis-investing existing services or technologies. We discuss potential means of integrating public views and values with other forms of evidence and sources of information. We describe and assess different interventions (formal structured processes and criteria) aimed at improving priority setting (as part of broader management of health systems) for resource allocation.
- This work fits within the broad definition of HTA—encompassing both material products and organizational and service structures—advocated by the Canadian Agency for Drugs and Technologies in Health (CADTH), and thus would be relevant and appropriate for this Symposium. [Session 14, April 29, 1030 – 1200, Neale Smith]
Session 15: April 29th - 10:30 – 12:00
The Use of the World Health Organization’s Defined Daily Dose in Drug Costs and Utilization Analyses
- Background: Drug utilization research is fundamental in guiding and supporting policy decisions that improve the use of pharmaceuticals in the population and shape the affordability and sustainability of health care in Canada. The World Health Organization’s Defined Daily Dose (DDD) is a widely accepted and applied methodology of quantifying drug usage in drug utilization analyses.
- Objective: To raise awareness regarding the applicability of DDD methodology in real-life analysis of drug costs and utilization in the context of administrative claims databases. In addition, the study puts forward an innovative approach, raising awareness regarding the already existing, yet underutilized, alternative quantity measure: the Reported Day Supply.
- Results Relevance: The findings of the study are of interest to health policy makers and other health care leaders who may rely on DDD methodology to analyze costs and patterns in drug utilization.
- Conclusions: Cost analysis based on DDD is meaningful only under special conditions which, the study demonstrates, are not likely to occur in real life. Examining data for several leading therapeutic classes, the study shows that Day Supply, as recorded by Canadian public drug plans, normally provides a reliable direct measure of utilization.
[Session 15, April 29, 1030 – 1200, Elena Lungu]
Methods for Individualizing the Integrated Benefit and Harm of Warfarin
- Background: Current approaches to drug benefit/harm assessment measure each independently. Combining benefit/harm assessment into one tool could enhance decision making, particularly for drugs for which both are clinically important.
- Objectives: To identify predictors of the four combined warfarin-related benefit/harm outcome groups: i) no stroke/no bleed, ii) no stroke/bleed, iii) stroke/bleed, iv) no stroke/no bleed.
- Methods: We analyzed patient-level data from the Atrial Fibrillation Investigators RCT database (n=9,155) and an observational database of atrial fibrillation patients managed by Kaiser Permanente Colorado (n=5,475) as inception cohorts. We classified patients based on the four outcome groups and applied polytomous logistic regression (PLR) to identify patient factors predicting each group (alpha=0.05).
- Results: PLR identified increasing age and warfarin use as predictive of all outcome groups. Additionally, this analysis identified predictors of stroke/no bleed and no stroke/bleed not included in risk-scoring models that predict strokes (CHADS2) and bleeds (HEMORR2HAGES) independently. Individual patient probability of each benefit/harm outcome group, based on the patient’s own data, can be calculated from predictor coefficients.
- Conclusions: Individual patient data analysis with PLR is a useful advancement towards evidence-based, tailored decision making. It requires further refinement and validation for clinical use, but could ultimately prove very valuable in predicting treatment response for new patients. [Session 15, April 29, 1030 – 1200, Jennifer Pereira]
The $50,000/QALY Threshold Reconsidered: A Retrospective on Klarman’s Original Paper with an Eye to the Future
- It has been 40 years (1968) since Herbert Klarman and colleagues published their paper in Medical Care establishing that the cost-effectiveness of renal dialysis is $50,000/QALY. This served as the basis for expanding the US Medicare program to provide universal coverage for end-stage renal disease and subsequently the basis upon which all new health technology has been compared. This standard has not changed despite years of inflation and structural changes in health care systems since this time.
- This paper will first re-examine Klarman’s work and show how he quality-adjusted life years in the wrong direction—producing ill-year rather than healthy-year equivalents; therefore, he grossly underestimates the cost-effectiveness ratio associated with kidney dialysis. The implication is that the $50,000/QALY threshold was too low if the intent was to compare new technologies against renal dialysis. Current conditions require that revised standards allow for change over time due to inflation and adjustment based on mitigating factors. Recent decisions by the Canadian Expert and Drug Advisory Committee (CEDAC) and the Ontario Committee for the Evaluation of Drugs (CED/DQTC) will be discussed to show that new flexible thresholds should allow for at least three adjustment factors: budget impact, age of therapeutic class, and whether the drug is curative.
[Session 15, April 29, 1030 – 1200, Eric Nauenberg]
Poster Presentations: [April 27, 1700 - 1900]
Adverse Drugs and their Relationship to Cognitive Decline in Community-Dwelling Older Adults
Scott Oddie
- The relationships among adverse drugs prescribed to community-dwelling older adults, health status, need for assistance with instrumental/activities of daily living (I/ADL), and cognitive status were examined. Criteria used to identify a prescribed drug as “adverse” included inappropriate duration and dosage of medication, known adverse interactions, and medications on the Beers Criteria lists. On average, participants were prescribed five medications and one of these met criteria for an adverse drug. As the number of medications increased, so did the probability of being prescribed an adverse drug. As the number of identified adverse drugs increased in participants, measures of attention, immediate memory, delayed memory, visuoconstruction ability, verbal fluency, and executive functioning all decreased significantly while controlling for health status. Increasing needs for assistance with I/ADL was significantly associated with both adverse drugs and declining health status. The results indicate a need for better identification and removal of adverse drugs to prevent cognitive decline.
Applying Sex and Gender Analysis to Evidence and Policy
Madeline Boscoe
- Increasingly, evidence demonstrates that sex and gender matter in health policy and health care. Thus there is a need for increased capacity-building in research synthesis and the application of research. The poster reports on an ongoing project developing and testing a Sex and Gender Based Analysis (SGBA) tool for use in systematic reviews. The workshop will provide an introduction to SGBA. The tool and the process by which it was developed will be described, and the results from the pilot test conducted will be presented. The workshop will conclude with a discussion of the application of the tool to technology assessments.
Appropriate Methodologies for Evidence-Based Decision Making, or the Need to Adjust Indirect Comparisons in Meta-Analyses: A Case Study
Pierre-Alexandre Landry
- Background: In the absence of head-to-head trials, researchers can perform indirect comparisons of controlled studies using a meta-analysis framework. The traditional approach is known to be methodologically flawed, since it disregards the control arms, potentially biasing comparisons. This study compares results from adjusted and unadjusted indirect comparisons of drugs used in management of neuropathic pain, focusing on anticonvulsants (ACs: gabapentin, pregabalin) and serotonin-norepinephrine reuptake inhibitors (SNRIs: venlafaxine, duloxetine).
- Methods: Randomized controlled trials were identified through a systematic literature search conducted in MedLine, EMBASE, and the Cochrane Library. Efficacy was compared using partial response (≥30% pain score reduction) or full response rates (≥50% pain reduction). Meta-analyses were performed using CMA software, version 2.0.
- Results: Using Relative Response Ratio (RR), the unadjusted meta-analysis suggested a greater response with SNRIs over ACs (unadjRRAC-SNRI=0.77). However, adjustment for placebo response revealed opposite results [adjRRAC-SNRI=1.55 (1.27 to 1.90)], indicating that pain reduction with ACs is significantly superior to that reported with SNRIs. A similar disparity was reported for partial response, with unadjRRAC-SNRI=0.83 compared with adjRRAC-SNRI=1.36 (1.13, 1.64).
- Conclusions: This case study underscores the importance of using a statistically sound, valid approach to indirect meta-analyses to derive reliable evidence to support difficult decision making.
Assessing Risk of Bias in Randomized Controlled Trials: A Case Study of the Cochrane Risk of Bias Tool
Donna Dryden
- Background: The Cochrane Collaboration recently developed a Risk of Bias (RoB) tool to assess internal validity of randomized controlled trials. The tool requires critical assessments for six domains — sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias.
- Objectives: To evaluate the feasibility and inter-rater agreement of the RoB tool and to evaluate concurrent validity compared with the Jadad scale, a commonly used quality assessment tool.
- Methods: Two reviewers independently applied the RoB tool to 80 trials that had previously been assessed using the Jadad scale. We tracked the time to complete the tool and assessed inter-rater agreement using weighted kappa. We tested for degree of correlation between Jadad scores and overall assessment of risk by the RoB tool using Kendall’s tau statistic (k).
- Results: Preliminary results indicate that the RoB tool takes, on average, nine to 13 minutes to complete. Agreement on individual domains ranged from poor (k=0.07 for incomplete outcome data) to good (k=0.75 for sequence generation); agreement for overall risk of bias was low (k=0.28). There was a positive correlation between Jadad scores and overall RoB assessment (k=0.512, p=0.006).
- Conclusions: There was substantial variation in agreement across domains of the RoB tool. Careful training and decision rules are required when using the tool.
Atlantic Collaboration for Decision Makers in Health
Lisa Farrell, Michael Allen, Ken Baird, Cindy Mosher, Stephanie Smith, Joyce Thompson
- “Evidence, Economics and Ethics for Tough Decision Making” was the theme of a recent conference in Atlantic Canada. This poster presentation will profile this engaging initiative aimed at supporting more informed health technology decision making among senior health executives. The intent is to share the Atlantic experience and stimulate discussion about effective ways to continue reaching these influential decision makers.
- On May 4, 2007, more than 60 senior health executives from the health ministries and district/regional health authorities in Atlantic Canada participated in an invitational conference co-hosted by CADTH and Dalhousie University Continuing Medical Education. A Planning Committee composed of senior executives from all four provinces provided significant input into planning, promoting, and delivering the event.
- The objective of the conference was tohelp senior health executives understand, explore, and discuss influential factors in making decisions about health technologies. Specifically, content and discussion focused on:
- Evidence-based resources
- Decision-making frameworks and approaches that formally incorporate evidence, ethics, and economics at the local/hospital, provincial, and/or Atlantic levels
- Opportunities for collaborative action.
- Through small work groups and other networking activities, participants were able to share ideas and problem-solve with their peers. The conference — the first of its kind in Atlantic Canada — was an initial step towards facilitating more deliberate, organized approaches for health technology decision making in the region.
Beyond Overcrowding: A Western Canadian Forum on Innovation and Evidence-Based Decision Making in Emergency Care
Brendalynn Ens, Donna Champagne, Jill Friedt, Ann Vosilla
- Emergency department (ED) overcrowding was identified as a common health care challenge facing many health regions and jurisdictions across Canada. A health technology assessment (HTA) on this issue, together with the Health Technology Inquiry Service (HTIS) report on Portable Ultrasound in Emergency Departments (completed in 2006), were highlighted at a western Canada conference and ultimately became the catalysts for a dynamic collaborative educational opportunity.
- The Saskatchewan Liaison Officer worked with the Regina Qu’Appelle Health Region as co-chair of this event, also involving other Western Canadian Liaison Officers. This brought together local and Western Canadian provincial groups, linking decision makers seeking to improve processes for emergency care issues. Presentations and interactive workshops at this conference were provided about how best to use evidence-based reports on topics of highest relevance.
- From evaluations, we learned that this conference provided an opportunity that successfully linked health providers with issues facing ER departments to HTA, to achieve increased awareness of evidence application. It also has served as a springboard for enhanced cooperation and additional opportunities for Western Canadian networking, sharing, and collaboration of ideas.
- Attendees have requested that this conference occur on an annual basis.
Bringing Context into the Health Technology Assessment Process
Craig Larsen, Kirsten Gartenburg, Hussein Noorani, Nancy Robertson
- Context is key to ensure that evidence appropriately informs policy and practice decisions. This poster will outline the key theories relevant to bringing a health care system context into the evidence development process. Audiences will also learn how the Canadian Agency for Drugs and Technologies in Health (CADTH) is bringing context into its health technology assessment process. This includes real-life examples of using context to help prioritize and refine health technology assessment topics to better meet decision-maker needs as well to support knowledge transfer planning.
A Case Study in Knowledge Translation: Developing a Conceptual Model to Evaluate the Role of Information and Communication Technology on Linkage and Exchange Processes in Distant Drug Policy Groups
Mowafa Househ
- Background: As health care groups continue to communicate about and collaborate on knowledge-translation-related activities over distance, information and communication technologies (ICTs) will play a larger role in supporting such interactions. However, to date, the literature of knowledge translation appears disconnected from that of ICTs.
- Methods: This case study focuses primarily on developing a refined conceptual model for the study of linkage and exchange processes of technology-enabled drug policy groups. The initial conceptual model was built from the research literature in both the information and communication technology and knowledge translation fields.
- Results: Three linkage and exchange knowledge translation processes were studied: social interaction norms, facilitation, and information exchange. The findings suggest that technology impacts group social interactions, facilitation and knowledge brokering, and how the evidence is shared.
- Conclusions: Information and communication technologies have a significant impact on knowledge translation activities.
- The implications of this study for both theory and the practical development of technology to support linkage and exchange are discussed in this poster.
Collaboration in Action: COMPUS and the CADC
Michael Allen, Tupper Bean, Shawn Bugden, Debbie Bunka, Anne Nguyen, Lorne Reiger, Richard Morrow, Sandra Rees
- The Canadian Academic Detailing Collaboration (CADC) is a group with representation from academic detailing programs across Canada (British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Nova Scotia). For several years, the Collaboration has worked with the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) to promote academic detailing and to facilitate the dissemination of evidence-based messages. A recent successful joint effort between the CADC and COMPUS has been the development and dissemination of evidence-based recommendations about optimal prescribing of proton pump inhibitors (PPIs).
- COMPUS developed evidence-based information about PPIs through an extensive review of guidelines, systematic reviews, and primary publications. Members of the CADC worked with COMPUS to create key educational messages and knowledge transfer tools, including interactive case studies, a newsletter, an alternate prescription pad to promote lifestyle changes, a cost-comparison chart, an upskilling document, a GI evidence overview, an evaluation framework, and a current-practice analysis. As a result, member programs of the CADC are delivering consistent, evidence-based messages about PPI prescribing to community-based clinicians across Canada. COMPUS and the CADC are an example of national and provincial evidence-based groups working together to promote optimal prescribing.
Comparison amongst Different Imaging Strategies for the Diagnosis and the Assessment of Acute Thoracic Aortic Dissection: Systematic Review and Meta-Analysis
Nicola Pace
- Objective: Evaluation of the best imaging strategy for the diagnosis and the evaluation of acute thoracic aortic dissection.
- Materials and Methods: A systematic review of the published literature has been performed in order to retrieve comparative works about sensitivity and specificity of transesophageal echocardiography (TEE), computed tomography (CT), and magnetic resonance (MR) for the diagnosis and the assessment of aortic dissection. Extracted data have been processed through a linear mixed model, estimating pooled sensitivity and specificity of each technique. Subsequently, a decision tree predictive model has been developed for estimating the overall 30-day survival rate due to the use of each diagnostic strategy. Combination of different techniques, dissection types, test results, and pre-test probabilities have been compared.
- Results: Twenty-one studies have been included in the meta-analysis. Sensitivity and specificity do not significantly differ among the different techniques (p<0.05). For low pre-test probability, the best survival comes from the performance of a single CT. For high pre-test probabilities, the best strategy is to perform a CT with a subsequent TEE.
- Conclusions: Within 95% confidence intervals, CT, TEE, and MR do not highlight significant differences in either sensitivity or specificity. The diagnostic strategy to be followed varies according to the pre-test probability.
Consensus Development Conferences
Rhonda Lothammer
- The Consensus Development Conference approach has been used effectively in Alberta by the Institute of Health Economics (IHE), with a variety of consensus development exercises reviewing the latest scientific evidence in areas of interest. The IHE conference program is modelled on the National Institutes of Health Consensus Development Program in the United States. The purpose of this conference series is to synthesize available scientific information on an issue and develop a consensus statement that advances understanding of the issue under consideration to better inform policy decision making. The statement is written by a panel of experts with an in-depth understanding of the issue. The panel and delegates attend presentations given by scientists who are internationally recognized as experts on the topic. The panel must synthesize this information into clear and accurate answers to a set of predetermined questions. Ideally these answers provide guidance in the form of multiple specific policy options to be considered on the topic. The rigorous consensus development conference format ensures the timely production of a succinct knowledge transfer tool that can be used by policy makers and other stakeholders to effect change in an area of specific concern.
A Cost-Effectiveness Analysis of Hepatitis C Screening among Immigrants in Canada
Wendong Chen
- Objective: To assess the costs and benefits of hepatitis C (HCV) screening among immigrants, since about 20% of HCV cases in Canada are immigrants.
- Methods: A decision analytic model was developed to assess HCV screening among immigrants. HCV epidemiology among immigrants, effectiveness of current anti-viral therapy (pegylated interferon plus ribavirin), and transition probabilities for the disease progression were estimated from published literature. The HCV incidence among immigrants was estimated using Pediatric HIV/AIDS Cohort Study (PHACSS) surveillance data. The costs associated with HCV screening tests, anti-viral therapy, and health care were estimated through published economic studies. The cost-effectiveness analysis for immigrants was further stratified by world regions.
- Results: HCV screening was associated with an increase of life years (0.0013 years) and cost ($40.60) when compared with no screening for all immigrants ($30,552 per additional life year). HCV screening for immigrants born in South Asia was associated with longer life years (0.0108 years) and less cost (-$50.60). The HCV screening strategy for immigrants born in Africa costs $8,635 to gain one additional life year. No obvious advantages of HCV screening were observed for immigrants from other areas.
- Conclusion: The preliminary findings suggest that it may be cost-effective to screen immigrants from South Asia and Africa.
Cost-Effectiveness of Breast Cancer Screening Programs in Canada
Ngoc-Thy Vu Dinh
- Problem: What is the impact on cost-effectiveness of varying programs for population-based breast cancer screening?
- Objective: To estimate the impact on cost-effectiveness of shortening and extending screening intervals and extending the age range for breast cancer screening in Canada.
- Methods:
Part I: A literature review of population-based breast cancer screening programs, models used to estimate health impacts of breast cancer screening programs, economic evaluations of breast cancer screening programs, methods for eliciting health utilities for cost-utility analyses, and high-risk groups for breast cancer for subsequent heterogeneity analysis. - Part II: Modelling the effects of the varying screening programs on life years saved and quality-adjusted life years. A micro-simulation approach will most likely be used based on a preliminary review of different models.
- Part III: A survey eliciting health state utilities.
- Part IV: A cost-utility analysis of varying breast cancer screening programs using the chosen model from Part II, with cost per quality-adjusted life year for each policy examined.
- Part V: Uncertainty analysis — determination of influential model inputs (parameters) and their impact on overall results. Heterogeneity analysis — a stratified analysis by high risk subgroups of the population (determined a priori from the literature review).
Cost-Effectiveness of Capsule Endoscopy in the Diagnosis of Obscure Gastro-intestinal Bleeding Caused by Angiodysplastic Lesions in Elderly Cardiac and Diabetic Patients
Florin Costea
- Background: Capsule endoscopy (CE) is an innovative non-invasive imaging method that allows the visualization of the entire small bowel mucosa. Selected studies reveal that angiodysplastic lesions (AL) of the digestive tract account for about 45% of the obscure gastro intestinal bleeding (OGIB).
- Aim: To compare the costs of a diagnostic algorithm based on the first-line use of CE with the current algorithm for diagnosing OGIB in a selected group of patients (elderly cardiac and diabetic patients).
- Methods: In a five-year (2002-2007) series of 270 patients referred for OGIB, having a mean of four non-diagnostic imaging investigations per patient, the CE revealed AL in 114 (43%) patients. Among these patients, 47 (41%) patients (mean age 69+/−6 years) had an underlying medical condition of interest. Clinical trial data on CE and input from clinical experts were used as data sources to identify the costs of diagnosing OGIB.
- Results: AL is an important cause of OGIB in elderly cardiac and diabetic patients. The total costs of traditional investigations used in the diagnosis of OGIB are comparable to the costs related to the use of CE as the first line of diagnosis in OGIB caused by AL in elderly cardiac and diabetic patients ($1,170 versus $1,500).
- Conclusion: CE has a higher diagnostic yield than all other imaging investigations in OGIB; the cycle of repeated traditional investigations with a lower diagnostic yield and the subsequent call for other investigations considerably increases the costs ($1,500 versus $2,230 for four other investigations per patient).
Cost- Effectiveness of Community Pharmacist-based Smoking Cessation Program: Evidence from Thailand
Kednapa Thavorn
- Objective: To assess the cost-effectiveness of a structured community pharmacist-based smoking cessation program in Thailand compared with usual care, from a health care system perspective.
- Method: A Markov model was used to simulate the effects of cessation on cohorts of 10,000 male and female smokers aged 40, 50, and 60 years, who regularly smoke 10 to 20 cigarettes per day. Transition probabilities were obtained from literature review, while medical care costs and utilization patterns were derived from the database of a Thai tertiary care hospital, and literatures. Costs of the smoking cessation program were obtained from a costing study of 40 Thai community pharmacies. Incremental cost per life-year gained (LYG) was calculated. The discount rate used was 3%. A series of sensitivity analyses, including probabilistic sensitivity analyses, were performed.
- Results: The community pharmacist-based smoking cessation program results in cost-savings of 17,503.53 baht (US$500) to the health system and LYG of 0.181 years for men, and costs-savings of 21,499.75 baht (US$614) and LYG of 0.244 years for women. A series of sensitivity analyses demonstrates that both cost-savings and LYG were sensitive to variations in the discount rate and the long-term smoking quit rate associated with the intervention.
- Conclusion: From the perspective of the health system, the structured community pharmacist-based smoking cessation program yields cost-savings and LYG. This finding provides important information for health policy decision makers when determining the magnitude of resources to be allocated to smoking cessation services in community pharmacies.
The Cost-Effectiveness of a Universal Herpes Zoster Vaccine Strategy
Mehdi Najafzadeh
- Background: Herpes zoster (HZ) results in significant morbidity and mortality in the elderly, including the development of post-herpetic neuralgia (PHN). We sought to compare the incremental cost and health benefits of HZ vaccine over status quo from the perspective of the Canadian health care payer.
- Methods: We developed a discrete event simulation model comparing the costs and quality-adjusted life years (QALYs) accrued to patients receiving HZ vaccine to those who did not. The effect of the vaccine on the 1) incidence of severe or mild to moderate HZ, 2) severity and duration of HZ; 3) incidence of PHN among patients with HZ, 4) duration of PHN, and 5) costs associated with treating HZ and PHN were modelled.
- Results: On average, receiving the vaccination lowered mean direct medical costs (excluding the vaccine costs) by C$47 per person. The incremental cost and QALYs per person receiving the vaccine versus those in the status quo strategy were C$103 and 0.0024 QALYs respectively, resulting in an ICER of C$42,300 per QALY gained. If confined to individuals between 60 and 64 years of age, the ICER would improve to C$30,800 per QALY gained. Results were robust in probabilistic and deterministic sensitivity analyses.
Defining and Measuring Success in Priority Setting
Shannon Sibbald
- Background: Priority setting (ps) has been defined as distribution of resources among competing interests. Ps is a messy, complex, and inevitable social process. How do decision makers know if they are doing it right or well? Currently there is little information or methods to evaluate ps.
- Objectives: To provide ps guidance for decision makers and answer: How can we evaluate success in ps? involves two steps: (1) define success from the stakeholders’ point of view (decision and policy makers, scholars, patients, public), (2) create and pilot test a tool to measure ps success.
- Methods:(1) Create a conceptual framework via consultation of literature and three empirical studies (interviews with Canadian decision makers, focus groups with a national representation of patients and policy makers, international Delphi study). (2) Create an evaluation tool via iterative process and psychometric testing. (3) Test the tool: pilot test to determine usability.
- Results:We define successful ps through 10 elements of a conceptual framework. We describe the development of an evaluation tool and the results of its pilot test. The framework and tool can be used to evaluate ps activities by identifying areas of success and opportunities for improvement.
- Policy Implications: Decision makers can find guidance for ps. The framework and tool contain both procedural and substantive goals of ps and specify both quantitative and qualitative dimensions. To our knowledge, this is the first comprehensive framework describing successful ps and the first tool to evaluate success. By evaluating success in ps, we can move toward improving ps.
Development and Implementation of a Business Intelligence Platform for Drug Surveillance and Reporting
Alison Supina, Donatus Mutasingwa, Joseph Amuah
- Evaluation of administrative drug data sources is essential for program management and has important applications for health surveillance. Optimal system applications should make this information available to a wide range of users and provide the capability for ad hoc analyses and automated reporting. Towards these goals, First Nations and Inuit Health (FNIH) Alberta Region recently developed and implemented a business intelligence platform. Effective development, implementation, and maintenance of this system require the support of an interdisciplinary team of epidemiologists, statisticians, clinicians, and information technologists. It also requires computer applications that provide adequate abilities to integrate, manage, and analyze complex health information. An iterative data assessment and analytic approach between analytic, technology, and program disciplines facilitates a process that optimizes the consistency, accuracy, and versatility of FNIH’s drug reporting system. Development also includes careful consideration of privacy legislation/policies and agreements between FNIH communities and federal agencies regarding data ownership and control. Dissemination of information includes automated reporting systems and requires structured training for users of front end applications. In addition, all users must be ensured timely access to adequate support from information technologies and analytic advice. FNIH is currently exploring the potential to expand this system to include other health data sources.
The Development and Validation of a Survey Instrument to Measure Public Perceptions of Potential Physician-Pharmaceutical Industry Interactions
Janine Arkinson
- Background: Interactions between physicians and the pharmaceutical industry have led to concerns about conflict of interest. A number of regulatory bodies have issued conflict of interest guidelines suggesting a threshold beyond which interactions are considered unacceptable. We completed a review on the public perspectives on physician-pharmaceutical industry interactions, confirming an absence of literature on the topic.
- Objective: To develop an instrument to measure the opinions of Canadians on potential physician-pharmaceutical industry interactions.
- Methods: A review of the relevant survey methodology literature has been conducted to determine appropriate methods for the proposed study. Based on the literature and regulatory guidelines, a survey was developed and has undergone initial psychometric testing and cognitive interviewing steps.
- Results: A telephone survey has been proposed. Questionnaire development resulted in 15 situational questions. Factors that may predict these opinions were included. Various validity and reliability measures were outlined to ensure that legitimate conclusions are drawn. Also, cognitive interviewing was conducted to understand factors determining public acceptability of these interactions.
- Conclusions: Survey development includes several steps to ensure a valid and reliable instrument. While physician-pharmaceutical industry interactions are a complicated issue, initial assessment indicates that our survey may be useful to measure the acceptability of physician-pharmaceutical industry interactions.
Economic Evaluation of Long-Acting Insulin Analogues for the Treatment of Patients with Type 1 and Type 2 Diabetes Mellitus in Canada
Chris Cameron
- Background: In 2005, $181 million was spent on insulin products, up 17.5% from 2004. Conversion from non-analogue to analogue insulins has increased expenditures. Policy makers require clinical and economic evidence for reimbursement decisions.
- Methods: Cost-utility analysis from the perspective of a third-party provincial payer was conducted using the CORE Diabetes Model. Clinical outcomes were derived from recent meta-analyses. Costs and utilities, both discounted at 5%, were obtained from published sources. Sensitivity analyses were performed to test robustness of results.
- Results: Type 1 diabetes mellitus (T1DM) — the incremental cost-utility ratio (ICUR) for insulin glargine relative to NPH, was $87,932 per quality-adjusted life year (QALY) gained [difference in (∆) cost, $3,423; ∆QALYs, 0.039]. The ICUR for insulin detemir compared with NPH, was $387,729 per QALY gained (∆cost, $4,344; ∆QALYs, 0.011). Type 2 diabetes mellitus (T2DM) — the ICUR for insulin glargine relative to NPH was $642,994 per QALY gained (∆cost, $4,945; ∆QALYs, 0.008). Insulin detemir was more costly ($6,521 per patient) and less effective (-0.034 QALYs) than NPH. Results were sensitive to variations of parameters in sensitivity analyses.
- Conclusion: Compared with NPH, the use of long-acting insulin analogues for the treatment of diabetes mellitus is associated with relatively high incremental cost-utility ratios.
Effect of a Maximum Allowable Cost (MAC) Reimbursement Policy on Patient Cost-Sharing for Test Strips for Self Monitoring of Blood Glucose (SMBG) in the Nova Scotia Seniors' Pharmacare Program (NSSPP)
Chiranjeev Sanyal
- Objective: To assess the effect of the MAC policy on patient cost-sharing for SMBG test strips in the NSSPP program.
- Methods: 2005/2006 NSSPP administrative claims data for beneficiaries who were 65 years of age or older on October 1, 2004, and who received SMBG test strips in the 110 days prior to April 1, 2005 were analyzed. For each test strip claimed, $0.74 was reimbursed. The costs for test strips to the NSSPP and to beneficiaries were determined in the following treatment categories: (1) insulin only, (2) antihyperglycemic agents (OAA) only, (3) insulin with OAA, and (4) no reimbursed diabetes medications.
- Results: The insulin-only category had the highest mean(SD) yearly cost per beneficiary $52.3($43.6), with the lowest cost per beneficiary of $36.7($34.8) in the no-reimbursed-diabetes-medication group. The percentage of the total cost covered by beneficiaries differed significantly between treatment categories (7.8% for insulin with OAA versus 16.8% for no reimbursed medications; p<0.001).
- Conclusion: The NSSPP covered the majority of the costs of test strips claimed, and beneficiaries contributed significantly different amounts depending on the type of diabetes medications they had claimed. Drug insurance programs should work with health care providers to attain optimal usage of test strips.
Evaluating the Use of Palivizumab during the 2005-2006 RSV Infection Period in Four University Teaching Hospitals in Québec
Sylvie Desgagnés, Marie-Claude Michel
- Background: Palivizumab is used to prevent serious infections caused by respiratory syncytial virus (RSV). It is administered to children at high risk of RSV infection as a 15 mg/kg intramuscular injection once monthly during RSV season, for a maximum of five doses. A patient must meet one of the six criteria issued by the Conseil du médicament for the use of palivizumab to obtain the treatment.
- Objective: To describe the population that received palivizumab, its use in four university teaching hospitals (UTH), and how its current use relates to the Conseil du médicament criteria.
- Methods: A total of 468 charts of patients who received at least one dose of palivizumab between September 1st, 2005, and May 30th, 2006, in four UTH were reviewed.
- Results: The average age of patients was 13.5 years ± 7.3 months, and most were born before the 33rd week of pregnancy. The average dose was 14.9 ± 0.6 mg/kg, the average delay between doses was 29 days, and 33% of patients received fewer than four doses. Among those hospitalized, only 27/468 (6%) had a positive RSV test. Overall compliance with the Conseil du médicament criteria was 100%. Administration of doses outside the four UTH resulted in incomplete data and sub-optimal monitoring of patients.
- Conclusions: Use of a pre-printed form increases compliance with palivizumab use criteria. Guidelines for documentation of palivizumab doses should be considered to improve monitoring of patients.
The Impact of Benefit Plan Design on Cost and Health Outcomes
Warren Chin
- Objective: When private payers implement benefit plan changes to control costs, the longer term consequences may not be considered. The objective was to identify scientific studies that examined the impact of changes in private drug plan formulary design on the health of private plan beneficiaries.
- Methods: A search of the medical literature was conducted using the PubMed search engine. Search terms included combinations of reimbursement, formulary, plan, payer, restriction, cost, and adherence.
- Results: Although no Canadian employer-sponsored drug plans were identified, there were 15 North American studies examining the effects of changes in drug plan design. The research demonstrated three key points. Aggressive cost-control measures reduced the use of prescribed medications, which led to the use of other more expensive health services. Higher levels of adherence to drug therapy, which increased drug costs, were associated with lower overall health costs. Employee satisfaction decreased when significant cost-sharing changes were introduced, when access was more restrictive, or when claims were denied.
- Conclusions: A short-term focus on controlling drug costs is likely to have negative consequences on the health, productivity, and satisfaction of plan members. Careful consideration of drug plan design and cost-sharing can improve medication adherence, health outcomes, employee satisfaction, and costs.
The Impact of Biologic Drugs on the Psoriasis Market: Patient Retention
Tania Redina, Jamie Foley
- Background: Psoriasis is estimated to affect more than 600,000 Canadians. Trends in this market have changed significantly since the introduction of biologic drugs as treatment options. Since then, the average total cost of psoriasis treatment has increased considerably, provoking additional studies on the cost-efficiency, efficacy, and safety of these new products.
- Objective: To measure the retention of patients on biologic products recently indicated for psoriasis as a proxy for the success of therapy.
- Methods: Patients receiving treatment for psoriasis were identified using claims-level data extracted from the Brogan Inc. public and private drug plan databases. Aggregate data from this cohort was subsequently employed to determine retention rates. Biologic drugs considered for this study included Amevive, Raptiva, Enbrel, Humira, and Remicade.
- Results: Initial findings show that retention rates differ significantly between the target products. Detailed results will be provided in the poster.
- Conclusions: Analysts quantifying retention rates of patients using biologics in the treatment of psoriasis must adjust their measures to account for the use of atypical gaps in treatment. An accurate estimation of retention rates will provide certain insight about the efficacy of biologics for policy makers. Further investigation is required to determine why poor retention rates are observed for some of these products.
Influenza Vaccine Delivery Programs: A Systematic Review
Beate Sander
- Background: Annual epidemics of influenza continue to cause worldwide morbidity, mortality, and societal disruption. Jurisdictions utilize a mix of influenza delivery strategies to reach vaccine coverage targets with varying success.
- Objective: This systematic review examines influenza vaccine immunization delivery programs and settings around the world to identify and describe successful programs.
- Methods: We searched MEDLINE and EMBASE databases to identify records describing the methods of delivering influenza vaccine to the population at large. A total of 1,844 records were initially screened, and 98 citations were selected as potentially relevant and obtained in full text. Detailed information was abstracted using a pre-specified 20-item data extraction form.
- Results: Most influenza immunization programs are targeted to vaccinate those at high risk of complications from influenza infection as well as their contacts in traditional settings such as physician offices. However, an increasing number of people are receiving the influenza vaccine in non-traditional settings such as pharmacies, schools, and in the workplace. Immunization programs in non-traditional settings are often more accessible and convenient, especially for the economically disadvantaged, inner-city, and minority populations.
- Conclusion: Health care provider’s offices, hospitals, and public health units continue to effectively deliver influenza vaccines to the general population.
Long-Term Sequelae of Hepatitis C Virus-Infected Canadian Post-Transfusion Compensation Claimant Cohort
Hla Hla Thein
- Background: A $1.1 billion compensation fund was established in 1998 to compensate Canadians who acquired hepatitis C virus (HCV) infection through blood transfusion from 1986 to 1990. The compensation agreement linked compensation levels to stage of liver disease. Accurate prognostic estimates were required to ensure the sufficiency of the fund. This paper reports the unique application of Markov model and comprehensive epidemiologic methods to estimate the prognosis of individuals who have claimed compensation (post-transfusion compensation claimant (PTCC) cohort).
- Methods: Clinical characteristics of claimants (n=5004) were used to define the starting distribution. Transition probabilities were derived from the PTCC cohort and literature, using the Markov maximum likelihood estimation method. HCV treatment efficacy was derived from the literature, and practice patterns were estimated from a national survey.
- Results: Twenty years following the index transfusion, approximately 9.8% of all living claimants (n=3773) had cirrhosis, and 0.5% developed hepatocellular carcinoma (HCC). The model predicted that the 20-year risk of HCV-related cirrhosis was 25.5%, while the risk of HCC and liver-related death was 6.4%, and 7.8%, respectively. The corresponding life-time (60-year) risks were 39.3%, 10.9%, and 23.5%, respectively.
- Conclusions: The Canadian PTCC cohort offers new and relevant prognostic information for post-transfusion HCV patients in Canada. The PTCC cohort is an invaluable resource with which to study the natural history and resource utilization of HCV-infected individuals in future studies.
The Missing 2%: PubMed NOT Medline
David Kaunelis
- All but approximately 2% of PubMed citations are found in Medline. Our objective was to establish a search filter for retrieving PubMed citations that are not found in OVID’s version of Medline. Representatives from OVID and the National Library of Medicine (NLM) were contacted to provide background information on the content found in Medline and PubMed. Further information was gathered from web-based sources. Two search filters were developed. The first was based on PubMed/Medline status fields while an additional filter was based on the PubMed entry date. Both filters were tested by a team of information specialists by comparing the results of identical searches in the two databases. A search on the term “publisher” in the PubMed status field was found to be effective in identifying the vast majority of PubMed citations not found in Medline. An additional search filter limiting to very recently added PubMed citations was also found to be useful. In reality, there is no fool-proof way to limit PubMed searches solely to citations that are not found in Medline. There is a considerable flow of information between the two databases before a citation is completely processed. As a result, the status field for an individual citation is updated regularly, making precise searching difficult. However, the above filters were found to work well in identifying unique PubMed citations.
Peer-Reviewed Publication of a New Drug Technology Following Initial Appearance at a Large Hematology Conference: Implications for Patients, Clinicians, Researchers, and Policy Makers
Michelle Kho
- Background: Conference abstracts, often the first public record of a study, serve as a catalyst to initiate clinical and policy change. On average, 45% of all conference abstracts subsequently appear in the peer-reviewed literature, however the generalizability of this finding to studies of one intervention, in one population, is unknown.
- Objectives: To determine the full publication rate of a cohort of abstracts, median time to publication, and predictors of these relationships.
- Methods: We included the first five years of clinical abstract reports of rituximab for non-Hodgkin’s lymphoma from American Society of Hematology meetings (1997-2001), identified all unique studies, and used electronic databases to identify full publications. We determined the full publication rate, median time to publication, and predictors of these outcomes.
- Results: Of 109 abstracts representing 86 unique studies, the publication rate was 52.3% [45, 95% CI (41.3, 63.2)], and the median time to publication was 1.4 years with 6.8 years median follow-up. Author affiliation with industry [odds ratio (OR) 95% CI=4.60 (1.32,16.08)] and presentation type [oral OR=5.94 (1.31, 26.88), poster OR=3.39 (1.24, 9.25)] independently predicted subsequent full publication in the adjusted analysis. We identified no predictors of time to publication.
- Conclusions: We suggest cautious consideration of data from conference proceedings to inform clinical or policy decisions regarding new drug technologies. Future work needs to examine the generalizability of our results to other diseases and technologies.
Practice Implications of Implementing Antidepressant Monitoring Guidelines in a Community-Based Setting for Children and Adolescents
Eva Kwan, Beverly Stich
- Background: Recommendations put forth in 2005 by the Food and Drug Administration (FDA) regarding the monitoring of antidepressants in children clearly highlight the issue of improved patient safety, but have significant ramifications in terms of human resources, particularly in outpatient settings.
- Objective: To develop a monitoring process for a community-based mental health agency and to determine the feasibility and implications of implementing a standardized process for all children prescribed antidepressants.
- Methods: A comprehensive, standardized antidepressant monitoring process was developed and implemented in a pilot sample of 36 patients who received antidepressant prescriptions. Feedback on the monitoring process was collected from the patient/family, the psychiatrist, and the monitoring nurse at the start and end of the monitoring period.
- Results: Families involved in the monitoring process were interested in participating and appreciative of the additional attention. Although the monitoring process represented only a portion of the monitoring recommendations put forward by the FDA, a significant amount of physician and nurse time was required to follow the process. This study resulted in several recommendations for monitoring antidepressants in a community-based setting.
- Conclusions: The implementation of antidepressant monitoring guidelines into routine practice requires dedicated resources and will require a change of practice in community-based settings.
Prevalence of Cardiovascular Disease Risk Factors in Aboriginal People
Tony Frial, Christine Folia
- Background: Cardiovascular disease (CVD) is on the rise among Aboriginal people in Canada. The rate of heart disease among First Nations people and Inuit is 1.5 times higher than the general Canadian population, and circulatory diseases are the second leading cause of death in First Nations people. Several CVD risk factors may contribute to the increased prevalence of CVD among Aboriginal people. The aim of this review was to compare prevalence of such factors among Aboriginal people and the general Canadian population.
- Methods: A literature search using MedLine and Google search engines was conducted using the following terms: North American Indians/Aboriginal, Canada, smoking, hypertension, obesity, metabolic syndrome. Studies reporting risk factor prevalence were used for data extraction.
- Results: The reported prevalence of each risk factor was greater among Aboriginal people than the general Canadian population, with the exception of hypertension: smoking — 40% to 74% versus 16% to 25%; obesity — 36% to 58% versus 18% to 36%; metabolic syndrome — 28% to 52% versus 21% to 26%; diabetes — 13% to 23% versus 2.5% to 5.6%; hypertension (measured/on treatment) — 27% to 42% versus 21% to 54%; hypertension (self report) — 13% to 20% versus 9% to 24%.
- Conclusions: CVD is a growing problem among Aboriginal people, and this increased prevalence of CVD risk factors may further heighten this health burden. More research into risk reduction and treatment programs is needed.
Projection Model of the Economic Burden of Diabetes — Simulation of Cost-Effectiveness Studies in the Alberta Population
Arto Ohinmaa
- Objective: The prevalence of diabetes has increased dramatically in Canada. To assist in policy decision making regarding diabetes prevention and treatment strategies, we developed an economic projection model that simulates the clinical and economic outcomes of new health technologies.
- Methods: The projection model is based on incidence, prevalence, and mortality rates obtained from the Alberta Diabetes Surveillance System (ADSS) and population projections. The life table type of model projects the population’s yearly progression into the diabetic states for five-year age bands for males and females. Alberta diabetes incidence and mortality trends from 1995 to 2005 were used to project prevalence and health care costs between 2006 and 2035. Patterns of changing incidence and mortality were extracted from the ADSS data using regression.
- Results: If current trends continue for the next 10 years, overall prevalence was found to double in 2035 to approximately 10% and total costs were found to increase by 300%, with the highest percentage increase found in cardiovascular and eye care. Some prevalence and cost results of simulations from hypothetical HTA interventions are shown.
- Conclusions: Our model enables population-level estimates of prevalence and cost of diabetes to be made using results from HTA studies. This type of modelling is useful for policy makers, especially in prevalent chronic diseases like diabetes.
Taking Account of Pharmacoeconomic and Societal Aspects in the Drug Evaluation Process of the Conseil du médicament du Québec: The Example of Anti-cancer Drugs
Dan Cooper, Lucie Robitaille
- Background: In general, the effectiveness of new drugs, and of anti-cancer drugs in particular, reflects sometimes modest clinical outcomes and often very high prices. In the current context of limited resources, the efficiency of these drugs is a concern for decision makers.
- Objectives: In agreement with Québec’s drug policy (la Politique du médicament), the Conseil du médicament has set up an expert committee to establish a terms of reference to assist decision making with regard to the pharmacoeconomic and societal aspects of anti-cancer drugs.
- Results: The Conseil du médicament du Québec accepted the recommendations issued by its expert committee and incorporated them into its internal evaluation process. It agreed to systemize the collection of relevant pharmacoeconomic information in a consistent manner by creating a summary table listing all new anti-cancer medications. Moreover, a diagram illustrating the evaluation process and the ethical values involved was devised. This poster will present the contents of the table and the diagram.
- Conclusions: The terms of reference for the pharmacoeconomic evaluation of drugs, in particular that of anti-cancer drugs, simplify comparison and maintain a certain level of consistency in the recommendations established. The diagram of the evaluation process underscores the scientific, ethical and contextual dimensions involved, and provides an enhanced framework for the considerations involved in formulating recommendations.
Towards a Strategy for Pharmaceutical Use in Manitoba
Sylvia Alessi-Severini
- Success of public policy rests on the co-operation and collaboration among stakeholders in the adoption and implementation of policies. An emerging public policy implementation issue is the management of chronic medication use (MCMU). A community-building workshop for decision makers, health care providers, and patients will identify needs and create solutions for policy implementation. Pre-workshop activities are aimed at producing a background paper that examines the need for MCMU and the various roles of the stakeholders in MCMU. The workshop will provide an environment that allows for the identification and acceptance of behavioral changes necessary for improving MCMU. Appreciative inquiry is used to help participants to discover the "best" of current practices with respect to MCMU. Through appreciative inquiry we will find out what is being done well, what we need to do more of, what would work better with some changes, and what we have not tried yet. The final objective of the workshop is not simply to stimulate in all stakeholders a willingness to pursue solutions, but also to produce a planned strategy for an effective provincial partnership around MCMU. A variety of knowledge translation initiatives will be used to disseminate the findings.
- Acknowledgments: This project has been funded by a grant from the Institute of Health Services and Policy Research – Canadian Institutes of Health Research (IHSPR-CIHR) and the Government of Manitoba.
Use of Anti-arthritic Medications among Glucosamine Recipients in the Canadian Forces
Janice Ma
- Background: Glucosamine was added to the Canadian Forces drug benefit list in 2002, despite equivocal evidence. It was thought that this product would reduce consumption of anti-arthritic drugs in responders.
- Objectives: To describe glucosamine use in our population and determine if use of anti-arthritic medications is reduced following initiation of glucosamine.
- Methods: A database review was performed to identify members receiving glucosamine. Odds ratio was calculated to gauge the likelihood of anti-arthritic drug use post-glucosamine, and average days’ supply of anti-arthritic drugs was compared pre- and post-glucosamine.
- Results: Of 7,577 patients who received a glucosamine prescription, 6,338 were excluded; more than 90% of exclusions were due to short course of therapy or non-compliance (n=5,954). Among patients who received a therapeutic course of treatment (n=1,218), use of anti-arthritic medications increased from 55.6% at baseline to 64.08% after initiation of glucosamine (OR=1.43, 95% CI 1.24 to 1.64). Average days’ supply of anti-arthritic medication per subject also increased after initiation of glucosamine, from 37 to 60 days’ worth of medication (p<0.0005).
- Conclusions: Use of glucosamine in our population was not consistent with anticipated patterns. These results and those of recent clinical trials will be used to inform revised criteria for this medication.
Valuing Rarity: A Case Study
Zahava Rosenberg-Yunger
- Objective: To describe and evaluate priority-setting two expensive orphan drugs (OD) — Cerezyme and Fabrazyme — in three countries.
- Methods: We conducted a qualitative case study in three independent drug advisory committees. Priority setting was evaluated against a leading conceptual framework for legitimate and fair priority setting. Interviews were conducted with 23 informants (i.e., committee members, patient groups, and industry).
- Results: 1) Description: OD reimbursement recommendations by expert panels were based on clinical evidence, cost, and cost-effectiveness analysis. 2) Evaluation: Committee members expressed preference for the current process, but were concerned with the fairness of the process for ODs. Other informants suggested the inclusion of other relevant values (e.g., a drug’s life-saving ability) in order to improve the priority-setting process.
- Conclusions: Priority setting for drugs is not solely a technical process (e.g., involving cost-effective analysis, evidence-based medicine). Priority setting of expensive ODs illustrates how consideration of a wider range of relevant values in drug reimbursement will enhance the fairness of the priority-setting process.