Frequency of severe valvular disease caused by mediastinal radiation among patients undergoing valve surgery in a community-based, regional academic medical center.

BACKGROUND: Our goal was to define the prevalence of radiation-induced valvular heart (RIVD) disease among patients undergoing cardiac valve surgery in a community-based, regional academic medical center. Mediastinal radiation is a treatment modality for various hematologic and solid malignancies; however, long-term cardiac complications, including radiation-induced valvular heart disease, can occur years after the radiation treatments. HYPOTHESIS: Mediastinal radiation exposure is an independent risk factor for valvular heart disease often necessitating valve replacement in patients without other risk factors for valve disease. METHODS: Between January 1, 1998 and September 1, 2007, we retrospectively analyzed our institution's cardiac surgical database over a 10 year period and identified 189 consecutive patients ≤ 50 years of age who underwent valve surgery. Using case-control matching, we assessed the prevalence of mediastinal radiation among these young patients with valve disease necessitating surgery and to their matched controls from all patients admitted to the hospital. RESULTS: Nine individuals (4.8%) were identified as having received previous mediastinal radiation, significantly increased from controls (p<0.0001), and 8 of whom had surgical or pathologic findings consistent with radiation damage. Compared with a matched case-control population, individuals who had severe valve disease and underwent valve replacement had a markedly increased prevalence of prior mediastinal radiation therapy. CONCLUSIONS: In conclusion, cardiologists must remain aware of the potential long term valvular complications in patients treated with mediastinal radiation. Increased surveillance for RIVD may be considered in the decades following radiation therapy.

Estimation of the impact of diabetes-related complications on health utilities for patients with type 2 diabetes in Ontario, Canada.

OBJECTIVES: The goal of this study was to analyze health-related quality of life (HRQL) data from a Canadian population with type 2 diabetes in order to estimate the disutility associated with experiencing a diabetes-related complication. METHODS: The EQ-5D, a standardized instrument for use as a measure of health outcome, was administered to 1,147 patients in Hamilton, Ontario, with type 2 diabetes. After controlling for age, gender, and duration of diabetes, changes in utility values were estimated by regressing the EQ-5D scores onto binary indicators for the presence of an event. The primary method of analysis was Ordinary Least Squares (OLS) and due to concerns over non-Normality, bootstrap standard errors (SE) were calculated. RESULTS: The analysis included 1,143 participants. Based on the OLS model, reductions in HRQL were associated with duration of diabetes (-0.0015, SE = 0.0006), experiencing a myocardial infarction (MI) (-0.059, SE = 0.017), amputation (-0.063, SE = 0.059), stroke (-0.046, SE = 0.023), and kidney failure (-0.102, SE = 0.047). CONCLUSION: This study estimated the reductions in HRQL associated with several important complications commonly experienced in patients with diabetes. The greatest impacts on HRQL were associated with kidney failure and MI. The utility values calculated here can be used to assess the outcome of interventions that reduce these diabetes-related complications and will have a useful impact on future economic evaluations of diabetes management strategies in Canada.

Results of a model analysis to estimate cost utility and value of information for intravenous immunoglobulin in Canadian adults with chronic immune thrombocytopenic purpura.

OBJECTIVE: The aim of this work was to estimate the cost-effectiveness of intravenous immunoglobulin (IVIg) compared with oral prednisone as a treatment for Canadian adults with persistent chronic immune thrombocytopenic purpura (ITP). METHODS: The lifetime costs and effectiveness of IVIg and prednisone were estimated from the perspective of a publicly funded health care system in Canada, using a Markov model that was developed based on a systematic clinical and economic review and recommendations of clinical experts in Canada. Transition probabilities (ie, point estimates and 95% CIs) were estimated from the studies identified in a systematic literature review using a random-effect meta-analysis; point estimates were weighted-mean values from the meta-analysis. No published studies directly estimate the utility weight for patients with relapsed or refractory ITP; therefore, a value of 0.76 was used, based on the mean of the utilities for thrombocytopenia without major bleeding or hemorrhagic stroke. Costs and incremental cost-effectiveness ratios were reported as year-2007 Can $. RESULTS: The incremental costs and quality-adjusted life-years (QALYs) of IVIg versus prednisone were Can $8080 and 0.0071, respectively, resulting in an incremental cost-effectiveness ratio of Can $1.13 million/ QALY in the base-case analysis. The probability of IVIg being cost-effective was 0 if the maximum willingness-to-pay (WTP) value for an additional QALY was below Can $40,000. The probability that IVIg would be cost-effective was only 20%, even if the WTP increased to Can $100,000. The expected value of perfect information (EVPI) and expected value of partial perfect information (EVPPI) were 0 if the WTP was less than Can $30,000. If WTP increased to Can $100,000, the EVPI was Can $1700, and the EVPPI was Can $1010 for utility weights of relapse/refractory states, Can $136 for initial response rates of the treatments, and Can $6 for first-year relapse rates for the treatments. CONCLUSION: Based on the current available clinical evidence, this model analysis of hypothetical patients suggests that IVIg may not be a cost-effective option for adults with persistent chronic ITP in Canada.

Effect of PCI on quality of life in patients with stable coronary disease.

BACKGROUND: It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease. METHODS: We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]). RESULTS: At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (+/-SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66+/-25 for physical limitations, 54+/-32 for angina stability, 69+/-26 for angina frequency, 87+/-16 for treatment satisfaction, and 51+/-25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76+/-24 versus 72+/-23 for physical limitation (P=0.004), 77+/-28 versus 73+/-27 for angina stability (P=0.002), 85+/-22 versus 80+/-23 for angina frequency (P<0.001), 92+/-12 versus 90+/-14 for treatment satisfaction (P<0.001), and 73+/-22 versus 68+/-23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups. CONCLUSIONS: Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657.)

Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients.

BACKGROUND: The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluations) trial compared the effect of percutaneous coronary intervention (PCI) plus optimal medical therapy with optimal medical therapy alone on cardiovascular events in 2287 patients with stable coronary disease. After 4.6 years, there was no difference in the primary end point of death or myocardial infarction, although PCI improved quality of life. The present study evaluated the relative cost and cost-effectiveness of PCI in the COURAGE trial. METHODS AND RESULTS: Resource use was assessed by diagnosis-related group for hospitalizations and by current procedural terminology code for outpatient visits and tests and then converted to costs by use of 2004 Medicare payments. Medication costs were assessed with the Red Book average wholesale price. Life expectancy beyond the trial was estimated from Framingham survival data. Utilities were assessed by the standard gamble method. The incremental cost-effectiveness ratio was expressed as cost per life-year and cost per quality-adjusted life-year gained. The added cost of PCI was approximately $10,000, without significant gain in life-years or quality-adjusted life-years. The incremental cost-effectiveness ratio varied from just over $168,000 to just under $300,000 per life-year or quality-adjusted life-year gained with PCI. A large minority of the distributions found that medical therapy alone offered better outcome at lower cost. The costs per patient for a significant improvement in angina frequency, physical limitation, and quality of life were $154,580, $112,876, and $124,233, respectively. CONCLUSIONS: The COURAGE trial did not find the addition of PCI to optimal medical therapy to be a cost-effective initial management strategy for symptomatic, chronic coronary artery disease.

Managing multiple projects: a literature review of setting priorities and a pilot survey of healthcare researchers in an academic setting.

OBJECTIVES: To summarize and then assess with a pilot study the use of published best practice recommendations for priority setting during management of multiple healthcare research projects, in a resource-constrained environment. METHODS: Medical, economic, business, and operations literature was reviewed to summarize and develop a survey to assess best practices for managing multiple projects. Fifteen senior healthcare research project managers, directors, and faculty at an urban academic institution were surveyed to determine most commonly used priority rules, ranking of rules, characteristics of their projects, and availability of resources. Survey results were compared to literature recommendations to determine use of best practices. RESULTS: Seven priority-setting rules were identified for managing multiple projects. Recommendations on assigning priorities by project characteristics are presented. In the pilot study, a large majority of survey respondents follow best practice recommendations identified in the research literature. However, priority rules such as Most Total Successors (MTS) and Resource Scheduling Method (RSM) were used "very often" by half of the respondents when better performing priority rules were available. CONCLUSIONS: Through experience, project managers learn to manage multiple projects under resource constraints. Best practice literature can assist project managers in priority setting by recommending the most appropriate priority given resource constraints and project characteristics. There is room for improvement in managing multiple projects.