Abstract Objective Specific methodological challenges are often encountered during cancer-related economic evaluations. The objective of this study was to provide specific guidance to analysts on the ...methods for the conduct of high-quality economic evaluations in oncology by building on the Canadian Agency for Drugs and Technologies in Health Guidelines for the Economic Evaluation of Health Technologies (third edition). Methods Fifteen oncologists, health economists, health services researchers, and decision makers from across Canada identified sections in Canadian Agency for Drugs and Technologies in Health guidelines that would benefit from oncology-specific guidance. Fifteen sections of the guidelines were reviewed to determine whether 1) Canadian Agency for Drugs and Technologies in Health guidelines were sufficient for the conduct of oncology economic evaluations without further guidance specific for oncology products or 2) additional guidance was necessary. A scoping review was conducted by using a comprehensive and replicable search to identify relevant literature to inform recommendations. Recommendations were reviewed by representatives of academia, government, and the pharmaceutical industry in an iterative and formal review of the recommendations. Results Major adaptations for guidance related to time horizon, effectiveness, modeling, costs, and resources were required. Recommendations around the use of final outcomes over intermediate outcomes to calculate quality-adjusted life-years and life-years gained, the type of evidence, the source of evidence, and the use of time horizon and modeling were made. Conclusions This article summarizes key recommendations for the conduct of economic evaluations in oncology and describes methods required to ensure that economic assessments in oncology are conducted in a standardized manner.
ST-Segment Deviation Analysis of the Admission 12-Lead Electrocardiogram as an Aid to Early Diagnosis of Acute Myocardial Infarction With a Cardiac Magnetic Resonance Imaging Gold Standard Thomas N. ...Martin, Bjoern A. Groenning, Heather M. Murray, Tracey Steedman, John E. Foster, Alex T. Elliot, Henry J. Dargie, Ron Selvester, Olle Pahlm, Galen Wagner With contrast-enhanced cardiac magnetic resonance imaging as a gold standard in the validation of current electrocardiographic criteria for the diagnosis of acute myocardial infarction, the consideration of ST-segment depression in addition to ST-segment elevation improved sensitivity from 50% to 84% without significant loss in specificity.
Annals of Emergency Medicine collaborated with an educational Web site, Academic Life in Emergency Medicine (ALiEM) to host a public discussion featuring the 2014 Annals article on the outpatient ...management of patients with a spontaneous pneumothorax by using pigtail catheters. The objective was to curate a 14-day (November 10 to 23, 2014) worldwide academic dialogue among clinicians about the article. Four online facilitators hosted the multimodal discussion on the ALiEM Web site, Twitter, and Google Hangout. Comments across the social media platforms were curated for this report, as framed by 4 preselected questions. Engagement was tracked through Web analytic tools. Blog comments, tweets, and video expert commentary involving the featured article are summarized and reported. The dialogue resulted in 1,023 page views from 347 cities in 49 countries on the ALiEM Web site, 279,027 Twitter impressions, and 88 views of the video interview with experts. This Global Emergency Medicine Journal Club created a virtual community of practice from around the world and identified common themes around the management of spontaneous pneumothorax, which included substantial practice variation in regard to inpatient versus outpatient management, location of chest tube, the use of aspiration, and chest radiography after placement.
Background Mental health status has been shown to influence functional outcome in a number of orthopaedic disorders. The purpose of this retrospective cohort study was to assess whether a diminished ...baseline Mental Component Summary (MCS) score on the Short Form-36 (SF-36) is predictive of less improvement in the Ankle Osteoarthritis Scale (AOS) score at the time of midterm follow-up after arthroplasty or arthrodesis for end-stage ankle arthritis. Methods Preoperative and postoperative patient scores on the SF-36 MCS and AOS questionnaires were obtained from the Canadian Orthopaedic Foot and Ankle Society (COFAS) End-Stage Ankle Arthritis Database. The relationship between the preoperative MCS score and the change in the total AOS score at the time of final follow-up was summarized with use of a Pearson correlation coefficient (r). Subgroup analyses according to the type of treatment (ankle arthrodesis versus ankle arthroplasty) and preoperative MCS score (<50 versus ≥50) were conducted. Results Of an initial 372 ankles enrolled, 337 (91%, ninety-five arthrodeses and 242 arthroplasties) were reviewed after a mean duration of follow-up of 5.2 ± 1.3 years. Analysis revealed no correlation between the preoperative MCS score and the change in the AOS score, from the preoperative baseline to either a mean 5.2 years postoperatively or two years postoperatively (r < 0.1 in both analyses). There was no difference in the change in the AOS score between patients with a preoperative MCS score of <50 and those with a preoperative MCS score of ≥50. Conclusions In our study of patients with end-stage ankle arthritis treated with arthroplasty or arthrodesis, preoperative mental health status (as measured with the MCS score) did not predict functional outcome (as measured by the change in the AOS score) at the time of intermediate-term postoperative follow-up. AOS scores improved for all patients, regardless of the preoperative MCS score. Level of Evidence Prognostic Level IV . See Instructions for Authors for a complete description of levels of evidence.
Regulatory bodies worldwide, including Health Canada, have issued warnings about prescribing antidepressants to children and adolescents. We sought to determine whether the Health Canada warning had ...the desired effects on prescribing patterns and outcomes and whether it had any unintended health consequences.
We examined data from prescription and health care databases representing more than 265 000 children, adolescents and young adults annually to determine changes in the rates of antidepressant prescription, use of health services and outcomes in these populations in the 9 years before and the 2 years after the Health Canada warning. We also examined the data for unintended changes in these rates among patients with anxiety disorders. We used young adults as the comparison group because they were not targeted by the warning.
Following the warning, the rate of antidepressant prescriptions decreased among children and adolescents (relative risk RR 0.86, 95% confidence interval CI 0.81-0.91) and among young adults (RR 0.90, 95% CI 0.86-0.93). Ambulatory visits because of depression decreased among children and adolescents (RR 0.90, 95% CI 0.85-0.96) and young adults (RR 0.91, 95% CI 0.87-0.96). The rate of completed suicides among children and adolescents rose significantly after the warning (RR 1.25, 95% CI 1.08-1.44; annual rate per 1000 = 0.04 before and 0.15 after the warning). There was no equivalent change in the rate of completed suicides among young adults (RR 1.01, 95% CI 0.93-1.10; annual rate per 1000 = 0.15 before and 0.22 after the warning). Among patients with an anxiety disorder, the prescription rates did not change among children and adolescents, except for a decrease in the use of selective serotonin reuptake inhibitors other than fluoxetine, but the rates among young adults changed similar to the pattern of changes in the overall prescribing of antidepressants. There was also a significant decrease in the rate of physician visits because of anxiety disorders among young adults after the warning.
Health advisories and warnings issued by regulatory bodies may have unintended consequences on the provision of care, delivery of health services and clinical outcomes. Further efforts are required to ensure that health warnings do not result in unexpected harm.
PDF
