Center for Evaluation of Medicines

Hamilton, Canada

Center for Evaluation of Medicines

Hamilton, Canada
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Cadarette S.M.,University of Toronto | Cadarette S.M.,Institute for Clinical Evaluative science | Carney G.,University of British Columbia | Baek D.,University of Toronto | And 6 more authors.
Osteoporosis International | Year: 2012

Summary We compared the patterns of osteoporosis medication prescribing between two provinces in Canada with different public drug coverage policies. Oral bisphosphonates were the primary drugs used, yet access to the secondgeneration oral bisphosphonates (alendronate, risedronate) was limited in one region. Implications of differential access to oral bisphosphonates warrants further study. Introduction Approved therapies for treating osteoporosis in Canada include bisphosphonates, calcitonin, denosumab, raloxifene, and teriparatide. However, significant variation in access to these medications through public drug coverage exists across Canada. We sought to compare patterns of osteoporosis medication prescribing between British Columbia (BC) and Ontario. Methods Using dispensing data from BC (PharmaNet) and Ontario (Ontario Drug Benefits), we identified all new users of osteoporosis medications aged 66 or more years from 1995/1996 to 2008/2009. We summarized the number of new users by fiscal year, sex, and index drug for each province. BC data were also stratified by whether drugs were dispensed within or outside public PharmaCare. Results We identified 578,254 (n=122,653 BC) eligible new users. Overall patterns were similar between provinces: (1) most patients received an oral bisphosphonate (93% in BC and 99% in Ontario); (2) etidronate prescribing declined after 2001/2002, reaching a low of 41% in BC and 10% in Ontario in 2008/2009; and (3) the proportion of males treated increased over time, from 7% in 1996/1997 to 25% in 2008/2009. However, we note major differences within versus outside the BC PharmaCare system. In particular, <2% of drugs dispensed within PharmaCare compared to 79% of drugs dispensed outside PharmaCare were for a secondgeneration bisphosphonate (alendronate or risedronate). Conclusions Oral bisphosphonates are the primary drugs used to treat osteoporosis in Canada. Prescribing practices changed over time as newer medications came to market, yet access to second-generation bisphosphonates through BC PharmaCare was limited. Implications of differential access to oral bisphosphonates warrants further study. © The Author(s) 2011.

Burden A.M.,University of Toronto | Paterson J.M.,Institute for Clinical Evaluative science | Paterson J.M.,University of Toronto | Paterson J.M.,McMaster University | And 7 more authors.
Osteoporosis International | Year: 2012

We studied new users of oral bisphosphonates and found that less than half persisted with therapy for 2 years, and interruptions in use were common. During a median observation period of 4.7 years, 10% of patients filled only a single prescription, 37% switched therapies and median cumulative exposure was 2.2 years. Introduction: We sought to describe bisphosphonate prescribing, persistence and cumulative exposure among seniors in Ontario, Canada. Methods: We used Ontario Drug Benefit pharmacy claims to identify residents aged ≥ 66 years who initiated oral bisphosphonate therapy between April 1996 and March 2009. The first date of bisphosphonate dispensing was considered the index date. Persistence with therapy was defined as continuous treatment with no interruption exceeding 60 days. We examined persistence with therapy and the number of extended gaps (>60 days) between prescriptions over time periods ranging from 1 to 9 years. We also identified the proportion of patients filling only a single prescription and switching to a different bisphosphonate, and calculated the median days of exposure irrespective of gaps in therapy. Results: A total of 451,113 eligible new bisphosphonate users were identified: mean age = 75.6 years (SD = 6.9), 84% female, and median follow-up length = 4.7 years. Persistence with therapy declined from 63% at 1 year to 46% at 2 years and 12% at 9 years. Among those with at least 5 years of follow-up (n = 213,029), 61% had one or more extended gaps in bisphosphonate therapy. Overall, 10% of patients filled only a single prescription, 37% switched to a different bisphosphonate and the median exposure was 2.2 years. Conclusion: Less than half of patients persisted with bisphosphonate therapy for 2 years and interruptions in therapy were common, with most patients experiencing two or more >60-day gaps in therapy. Interventions are needed to improve persistence with bisphosphonate therapy and reduce the frequency of gaps in treatment. © 2011 The Author(s).

O'Reilly D.,Research Institute St Josephs Healthcare | O'Reilly D.,McMaster University | O'Reilly D.,Center for Evaluation of Medicines | Tarride J.-E.,Research Institute St Josephs Healthcare | And 7 more authors.
Journal of the American Medical Informatics Association | Year: 2012

Objective: To conduct a systematic review and synthesis of the evidence surrounding the cost-effectiveness of health information technology (HIT) in the medication process. Materials and methods: Peer-reviewed electronic databases and gray literature were searched to identify studies on HIT used to assist in the medication management process. Articles including an economic component were reviewed for further screening. For this review, full cost-effectiveness analyses, cost-utility analyses and cost-benefit analyses, as well as cost analyses, were eligible for inclusion and synthesis. Results: The 31 studies included were heterogeneous with respect to the HIT evaluated, setting, and economic methods used. Thus the data could not be synthesized, and a narrative review was conducted. Most studies evaluated computer decision support systems in hospital settings in the USA, and only five of the studied performed full economic evaluations. Discussion: Most studies merely provided cost data; however, useful economic data involves far more input. A full economic evaluation includes a full enumeration of the costs, synthesized with the outcomes of the intervention. Conclusion: The quality of the economic literature in this area is poor. A few studies found that HIT may offer cost advantages despite their increased acquisition costs. However, given the uncertainty that surrounds the costs and outcomes data, and limited study designs, it is difficult to reach any definitive conclusion as to whether the additional costs and benefits represent value for money. Sophisticated concurrent prospective economic evaluations need to be conducted to address whether HIT interventions in the medication management process are cost-effective.

O'Reilly D.,Research Institute St Josephs | O'Reilly D.,McMaster University | Holbrook A.,McMaster University | Holbrook A.,Center for Evaluation of Medicines | And 6 more authors.
Journal of the American Medical Informatics Association | Year: 2012

Background: Computerized decision support systems (CDSSs) are believed to enhance patient care and reduce healthcare costs; however the current evidence is limited and the cost-effectiveness remains unknown. Objective: To estimate the long-term cost-effectiveness of a CDSS linked to evidence-based treatment recommendations for type 2 diabetes. Methods: Using the Ontario Diabetes Economic Model, changes in factors (eg, HbA1c) from a randomized controlled trial were used to estimate cost-effectiveness. The cost of implementation, development, and maintenance of the core dataset, and projected diabetesrelated complications were included. The base case assumed a 1-year treatment effect, 5% discount rate, and 40-year time horizon. Univariate, one-way sensitivity analyses were carried out by altering different parameter values. The perspective was the Ontario Ministry of Health and costs were in 2010 Canadian dollars. Results: The cost of implementing the intervention was $483 699. The one-year intervention reduced HbA1c by 0.2 and systolic blood pressure by 3.95mm Hg, but increased body mass index by 0.02kg/m 2, resulting in a relative risk reduction of 14% in the occurrence of amputation. The model estimated that the intervention resulted in an additional 0.0117 quality-adjusted life year; the incremental cost-effectiveness ratio was $160 845 per quality-adjusted life-year. Conclusion: The web-based prototype decision support system slightly improved short-term risk factors. The model predicted moderate improvements in long-term health outcomes. This disease management program will need to develop considerable efficiencies in terms of costs and processes or improved effectiveness to be considered a cost-effective intervention for treating patients with type 2 diabetes.

Perera G.,Center for Evaluation of Medicines | Holbrook A.,Center for Evaluation of Medicines | Holbrook A.,McMaster University | Thabane L.,Center for Evaluation of Medicines | And 6 more authors.
International Journal of Medical Informatics | Year: 2011

Objective: To determine how patients and physicians balance the perceived benefits and harms of sharing electronic health data for patient care and for secondary purposes. Design: Before-after survey of patients and providers in practices using electronic medical records (EMRs) enrolled in a clinical trial in Ontario, Canada. Measurements: Outcomes were measured using the Health Information Privacy Questionnaire (HIPQ) at baseline and end of study. Thirteen questions in 4 general domains investigated attitudes towards the privacy of EMRs, outsider's use of patient's health information, the sharing of patient's information within the health care system, and the overall perception of benefits versus harms of computerization in health care. Results: 511 patients (mean age 60.3 years, 49.6% female) and 46 physicians (mean age 47.2 years, 37.0% female) participated. Most (>90%) supported the computerized sharing of the patient's health records among their health care professionals and to provide clinical advice. Fewer agreed that the patient's de-identified information should be shared outside of the health care circle (<70%). Only a minority of either group supported the notion that computerized records can be keep more private than paper records (38-50%). Overall, a majority (58% patients, 70% physicians) believed that the benefits of computerization were greater than the risks of confidentiality loss. This was especially true for patients who were frequent computer users. Discussion: While these primary care physicians and their patients valued the clinical features of EMRs, a substantial minority have concerns about the secondary use of de-identified information. © 2010 Elsevier Ireland Ltd.

Lam C.G.,University of Toronto | Manlhiot C.,University of Toronto | Pullenayegum E.M.,McMaster University | Pullenayegum E.M.,Center for Evaluation of Medicines | Feldman B.M.,University of Toronto
Annals of the Rheumatic Diseases | Year: 2011

Intravenous immunoglobulin (IVIg) is an adjunctive therapy for juvenile dermatomyositis (JDM) patients with poor response to first-line therapy (corticosteroid resistant; SR) or who are corticosteroid dependent (SD). Patients requiring IVIg are generally expected to have poorer outcomes, leading to confounding by indication in observational studies. Few studies have evaluated IVIg efficacy in JDM. Objectives: Compared with similar matched controls, to determine if JDM IVIg recipients achieve quiescence sooner and have less disease activity. For SD patients, to determine if IVIg recipients exhibit less disease activity than IVIg-naive patients. Methods: A retrospective inception cohort of 78 JDM patients was studied. Kaplan-Meier survival determined time to quiescence. Marginal structural modelling was used to account for confounding by indication by incorporating inverse probability of treatment weights to handle patients' unequal likelihood of receiving IVIg. Results: While similar demographically, the 30 IVIg patients demonstrated weaker muscle strength and more had photosensitivity at baseline than the 48 controls. As expected, IVIg patients achieved quiescence later than controls in unadjusted analysis. However, although IVIg patients started with greater disease activity, after accounting for confounding as best possible, they maintained similar or lower disease activity than controls from 30 days to 4 years post-diagnosis. This improvement was most marked in SR patients. Among SD patients, IVIg recipients maintained lower disease activity than IVIg-naive patients. Conclusion: This study, involving the largest JDM cohort receiving IVIg to date, applied bias-reduction methods and demonstrated IVIg efficacy in controlling JDM disease activity, particularly for SR patients.

Wong P.Y.H.,McMaster University | Schulman S.,McMaster University | Woodworth S.,University of Toronto | Holbrook A.,McMaster University | Holbrook A.,Center for Evaluation of Medicines
Journal of Thrombosis and Haemostasis | Year: 2013

Objective: Lack of patient knowledge has been associated with poor anticoagulation control, but the effect of patient education on clinical outcomes is unclear. We systematically reviewed the effect of supplemental patient education vs. usual care on hemorrhage, thromboembolic events (TEEs), time in therapeutic range (TTR) and knowledge test scores for all oral anticoagulants. Data sources: The data sources were electronic databases, including MEDLINE, EMBASE, CENTRAL, CINAHL and IPA, to February 2012 examining any oral anticoagulant. We reviewed references for additional potentially relevant studies. Methods: Only randomized controlled trials (RCTs) were considered. Data extraction and quality assessment were conducted with GRADE. Pooled relative risks (RRs) were calculated, and heterogeneity was determined by use of χ2 and I2 statistics. Results: Seven RCTs (n = 1209) were included in the systematic review, and five RCTs (n = 847) in the meta-analysis. All included studies examined vitamin K antagonists. No significant difference was found for hemorrhage (RR 0.92, 95% confidence interval [CI] 0.04-20.56), TEE (RR 0.66, 95% CI 0.10-4.39), a composite outcome of hemorrhage or TEE (RR 0.48, 95% CI 0.23-1.01), or TTR (mean absolute difference of 2.02%, 95% CI - 2.81 to 6.84). Evidence was conflicting on the impact of supplemental education on test scores. All trials had at least one substantial methodologic limitation. Conclusion: Current evidence does not support supplemental patient education as a means to improve patient outcomes, but the quality of this evidence is poor. Larger randomized trials are needed with longer follow-up, recruitment of patients initiating anticoagulation in primary care settings, and clearly defined education interventions. © 2012 International Society on Thrombosis and Haemostasis.

Sherifali D.,McMaster University | Nerenberg K.,University of Toronto | Pullenayegum E.,McMaster University | Pullenayegum E.,Center for Evaluation of Medicines | And 2 more authors.
Diabetes Care | Year: 2010

OBJECTIVE- Previous reviews of the effect of oral antidiabetic (OAD) agents on A1C levels summarized studies with varying designs and methodological approaches. Using predetermined methodological criteria, we evaluated the effect of OAD agents on A1C levels. RESEARCH DESIGN AND METHODS- The Excerpta Medica (EMBASE), the Medical Literature Analysis and Retrieval System Online (MEDLINE), and the Cochrane Central Register of Controlled Trials databases were searched from 1980 through May 2008. Reference lists from systematic reviews, meta-analyses, and clinical practice guidelines were also reviewed. Two evaluators independently selected and reviewed eligible studies. RESULTS- A total of 61 trials reporting 103 comparisons met the selection criteria, which included 26,367 study participants, 15,760 randomized to an intervention drug(s), and 10,607 randomized to placebo. Most OAD agents lowered A1C levels by 0.5-1.25%, whereas thiazolidinediones and sulfonylureas lowered A1C levels by ∼1.0-1.25%. By meta-regression, a 1% higher baseline A1C level predicted a 0.5 (95% CI 0.1-0.9) greater reduction in A1C levels after 6 months of OAD agent therapy. No clear effect of diabetes duration on the change in A1C with therapy was noted. CONCLUSIONS- The benefit of initiating an OAD agent is most apparent within the first 4 to 6 months, with A1C levels unlikely to fall more than 1.5% on average. Pretreated A1C levels have a modest effect on the fall of A1C levels in response to treatment. © 2010 by the American Diabetes Association.

Levine M.A.H.,Center for Evaluation of Medicines | Levine M.A.H.,McMaster University | El-Nahas A.I.,Center for Evaluation of Medicines | Asa B.,Center for Evaluation of Medicines
Journal of Clinical Epidemiology | Year: 2010

Objective: To determine the frequency of inappropriate use of arithmetic scales to present relative risk (RR) and odds ratio (OR) data in figures among a group of high-profile general medical journals. Study Design and Setting: Articles presenting RR or OR data in figures and published in one of five journals during 2002-2003 and 2007-2008 were evaluated to determine the type of scale used with the figures. Logarithmic and reciprocal (inverse) scales were identified as appropriate, whereas arithmetic scales were deemed inappropriate. If an article included one or more inappropriate figures, it was counted once as an incorrect publication. Results: Fifty-two percent (53 of 101) of the articles with a graphical presentation of RR or OR data had used an inappropriate scale in 2002-2003 and 25% (58 of 231) in the time period 2007-2008. Although all five journals showed some improvement over the 5-year interval, there continued to be a problem with inappropriate presentations occurring with one in four articles. Conclusion: Given the perpetuation of this problem, it may be time for the International Committee of Medical Journal Editors to address this issue by requiring that figures portraying ratio data use only logarithmic or reciprocal scales. © 2010 Elsevier Inc. All rights reserved.

Xie F.,McMaster University | Oremus M.,McMaster University | Gaebel K.,McMaster University | Gaebel K.,Center for Evaluation of Medicines
Quality of Life Research | Year: 2012

Purpose: Little research exists to indicate whether the general public can provide proxy health-related quality-oflife (HRQoL) estimates for persons with Alzheimer's disease (AD). We investigated (1) whether the general public can differentiate between mild, moderate, and severe AD and (2) whether the general public's proxy HRQoL estimates are correlated with current health status. Methods: We conducted computer-assisted personal interviews. The computer randomly assigned each participant to read a vignette describing mild, moderate, or severe AD. Participants answered the EQ-5D-5L and Quality-oflife-Alzheimer's Disease (QoL-AD), while imagining living in the health state described in their assigned vignette. Participants also answered the EQ-5D-5L based on their health state at the time of the interview. Results: We interviewed 100 participants. EQ-5D-5L utilities were 0.7413 (mild), 0.6159 (moderate), and 0.4456 (severe) (P<0.001). Mean QoL-AD scores were 32.5 (mild), 24.0 (moderate), and 21.8 (severe) (P <0.0001 for severe vs. mild, moderate vs. mild; P> 0.05 for severe vs. moderate). Participants' EQ-5D-5L utility scores were weakly correlated (r ≤ 0.28) across both administrations of the instrument. Conclusions: The general public can differentiate between the three stages of AD, and their HRQoL estimates for AD are weakly correlated with their current health status. © Springer Science+Business Media B.V. 2011.

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