Standard Gamble Method Research Articles

Clinical Trials in Orthopaedics Research. Part III. Overcoming Operational Challenges in the Design and Conduct of Randomized Clinical Trials in Orthopaedic Surgery

As we aspire to implement evidence-based medicine in the daily practice of orthopaedics, it is critical to understand the level of evidence that guides routine clinical decisions. Randomized controlled trials (RCTs) offer methodology for delivering the highest level of evidence1. Whereas the first RCTs were conducted half a century ago to test the efficacy of new pharmacologic agents, such trials are now being used increasingly to evaluate therapies other than medications, including surgery and behavioral interventions. Surgical RCTs involve additional complexity with regard to several key methodological components of the RCT: the willingness of patients to enroll, implementation of blinding (masking), and the impact of crossovers from one trial arm to another. The American Academy of Orthopaedic Surgeons (AAOS) and the Orthopaedic Research Society (ORS) sponsored a symposium on clinical trials in orthopaedic research in May 2009 at which each of these challenges was discussed2,3. Discussions during the symposium focused on offering suggestions regarding how to address these methodological issues during the design and implementation phases of a study. This paper summarizes key discussion points highlighted during the AAOS-ORS Symposium and comments on related issues, including compliance with nonsurgical regimens in studies comparing surgery with nonoperative treatment and the appropriate use of subgroup analysis. The paper concludes with suggestions regarding cost-effectiveness analysis in orthopaedic research. For an RCT to make a difference in the clinical management of musculoskeletal disorders, it must be planned carefully. In addition to detailed specification of the treatment regimen for each arm in the trial, it is critical to perform a careful analysis of the sample size required to conduct a trial that is conclusive (positive or negative). A study with an insufficient sample size may fail to detect a statistically significant difference between the arms of the study even …

Interpretation of Health and Vision Utilities in Low Vision Patients

The purpose of the study is to evaluate the relationship between time trade off (TTO) and standard gamble (SG) estimates of health and vision utilities in a low vision patient sample. Telephone surveys were conducted on 74 low vision patients. All study participants were administered utility questionnaires that used the TTO and SG methods as they relate to health and vision. There is high between-person variability in the relationship of TTO- to SG-estimated utilities for both vision and health. However, when transformed to logits, differences between TTO and SG utilities for health are equal to differences between TTO and SG utilities for vision. These differences are symmetrically distributed around the origin. The data were consistent with a model that includes both health or vision state and personal response criteria. The model explains between-person variability in the relationship of TTO to SG utilities as idiosyncratic differences within people between response criteria for making TTO and SG judgments. The large between-person variability in the relation of utilities estimated from TTO to those estimated from SG can be explained by large between- and within-person variability in personal TTO and SG response criteria. However, within each person, the response criteria used to judge health state are the same as the response criteria used to judge vision state. This observation leads to the conclusion that health and vision states are in the same units when estimated from utilities. A meta-analysis of published studies that compared TTO with SG utilities for different health states confirms the conclusion of the model that average utilities across people are criterion-free estimates of average health-related states on a common logit scale.

Cost-utility analysis of adjuvant goserelin (Zoladex) and adjuvant chemotherapy in premenopausal women with breast cancer

BackgroundIncreased health care costs have made it incumbent on health-care facilities and physicians to demonstrate both clinical and cost efficacy when recommending treatments. Though studies have examined the cost-effectiveness of adjuvant goserelin with radiotherapy for locally advanced prostate cancer, few have compared the cost-effectiveness of adjuvant goserelin to adjuvant chemotherapy alone in premenopausal breast cancer.MethodsIn this retrospective study at one hospital, the records of 152 patients with stage Ia to IIIa ER + breast cancer who received goserelin or chemotherapy were reviewed. Survival analysis was assessed by the Kaplan-Meier method. Patients were interviewed to evaluate their quality of life using the European Organization for Research and Treatment Quality of Life questionnaire (EORTC-QLQ-C30, version 4.0), and to obtain the utility value by the standard gamble (SG) and visual scale (VS) methods. Total medical cost was assessed from the (National Health Insurance) NHI payer's perspective.ResultsSurvival at 11 years was significantly better in the groserelin group (P < 0.0012). The lifetime lost was lower in the goserelin group (42 months vs. 66 months). The quality adjusted survival (QAS) of patients who received goserelin was longer (122.5 ± 6.3 vs. 112.2 ± 6.7 months). Total expenses of goserelin were more than cyclophosphamide, methotrexate, 5-fluorouracil (CMF) or 5-fluorouracil, epirubicin, cyclophosphamide (FEC) chemotherapy regimes, but less than docetaxel, epirubicin (TE) or docetaxel, epirubicin, cyclophosphamide (TEC) regimes. The quality-adjusted life-year was higher in the goserelin group.ConclusionsGoserelin therapy results in better survival and higher utility-weighted life-years, and is more cost-effective than TC or TEC chemotherapy.

The Quality-of-Life Impact of Head and Neck Cancer: Preference Values from the Canadian General Public

ObjectivesTo elicit preferences for standardized head and neck cancer (HNC) health states describing the health-related quality of life (HRQoL) impact of cancer type or stage, progression, or treatment-related toxicities; and to measure the association between an individual’s locus of control (LOC) and mean preference values for HNC health states. Study DesignWe elicited preferences from a sample of 106 members of the Canadian general public, using the standard gamble method. Eight health states representing HNC characteristics, and 10 describing treatment-related toxicities, were developed based on literature review, data analysis, and clinician interview. All participants valuated these, anchored against full health and dead, and completed the Multidimensional Health LOC scale. A mixed-regression model was used to calculate adjusted preference decrements for all states compared with a reference state (locoregional preprogression nonlaryngeal HNC). ResultsMean participant age was 47 years, and 48% were male. All health states were associated with substantially decreased preferences compared with full health. Mean preferences ranged from 0.62 (locoregional laryngeal HNC) to 0.33 (hospitalization for severe toxicity). After adjusting for age and sex, mean preference decrements were: −0.28 (postprogression), −0.11 (metastases), and −0.05 (recurrent disease). There was suggestive evidence that LOC was associated with preferences overall (P=.079); those with stronger beliefs in Chance rated health states lower (P=.012). ConclusionsHealth state preferences elicited here demonstrate that members of the Canadian general public rate HNC to have a large negative impact on HRQoL. The greatest impact was for postprogression and metastatic health states. These values are useful for quantifying the devastating impact of HNC on HRQoL, and for economic modeling.

Preferences for type 2 diabetes health states among adolescents with or at risk of type 2 diabetes mellitus

We evaluated how adolescents with or at risk of type 2 diabetes (T2DM) and their parent/guardians (parents) value health states associated with T2DM. We interviewed overweight/obese [Body Mass Index (BMI) ≥ 85th percentile], 12-18-yr old adolescents with T2DM, prediabetes, or insulin resistance (IR) and a parent. The standard gamble (SG) method elicited preferences (utilities) for seven hypothetical T2DM health states reported on a scale from 0 (dead) to 1 (perfect health). Adolescent's current health was evaluated with the SG and Health Utilities Index (HUI). There were 70 adolescents and 69 parents. Adolescents were 67.1% female and 15.5 ± 2.2 yr old; 30% had T2DM, 30% prediabetes, and 40% IR. Almost half (48.6%) had a BMI > 99th percentile. Parents (83% mothers) were 45.1 ± 7.3 yr old and 75% had at least some college/technical school education. Adolescents and parents rated T2DM with no complications treated with diet as most desirable [median (IQR); adolescent 0.72 (0.54, 0.98); parent 1.0 (0.88, 1.0)] and end-stage renal disease as least desirable [adolescent 0.51 (0.31, 0.70); parent 0.80 (0.65, 0.94)]. However, adolescents' utilities were significantly lower (p ≤ 0.001) than parents for all health states assessed. Adolescents' assessments of their current health with the SG and HUI were not correlated. Adolescents with or at risk of T2DM rated treatments and sequelae of diabetes as significantly worse than their parents. These adolescent utilities should be considered in the evaluation of treatment strategies for youth with T2DM. Family-based programs for T2DM must also be prepared to address conflicting preferences in order to promote shared decision-making.

Predictors of Health-Related Quality-of-Life Utilities Among Persons With Posttraumatic Stress Disorder

This study had two objectives: to elicit preferences for current health in a sample of persons with posttraumatic stress disorder (PTSD ) in order to establish quality-of-life estimates for this disorder and to identify symptoms and problems that predict these estimates. The authors used the standard gamble (SG), time tradeoff (TTO), and visual analog scale (VAS) methods for quality-of-life estimation at baseline among 184 individuals with chronic PTSD who were participating in a multisite clinical trial. Descriptive statistics were used to characterize quality-of-life estimates for the sample. A linear mixed-effects regression model was conducted to evaluate predictors of quality of life. The modal participant was a single, white female (77%). The mean ± SD age of the sample was 37.31 ± 11.33. On a scale where full health is 1.0 and death is 0.0, mean quality-of-life estimates for living with PTSD were .87 ±.25, .66 ± .28, and .64 ± .20 for SG, TTO, and VAS, respectively. Linear mixed-effects model regression revealed that elicitation method (SG, TTO, and VAS), arousal (a symptom of PTSD), and endorsement of anxiety or depressive symptoms were the strongest predictors of lower quality-of-life scores. Avoidance and re-experiencing of trauma were not predictive of reduced quality of life. Significant decrements in health-related quality of life were found among persons seeking treatment for PTSD. Although arousal and anxiety and depressive symptoms were predictive of quality-of-life estimates, avoidance and re-experiencing were not. These findings identify targets for symptom resolution that may improve quality of life among persons with PTSD.

Predictors of Health-Related Quality-of-Life Utilities Among Persons With Posttraumatic Stress Disorder

Objectives: This study had two objectives: to elicit preferences for current health in a sample of persons with posttraumatic stress disorder (PTSD ) in order to establish quality-of-life estimates for this disorder and to identify symptoms and problems that predict these estimates. Methods: The authors used the standard gamble (SG), time tradeoff (TTO), and visual analog scale (VAS) methods for quality-of-life estimation at baseline among 184 individuals with chronic PTSD who were participating in a multisite clinical trial. Descriptive statistics were used to characterize quality-of-life estimates for the sample. A linear mixed-effects regression model was conducted to evaluate predictors of quality of life. Results: The modal participant was a single, white female (77%). The mean±SD age of the sample was 37.31±11.33. On a scale where full health is 1.0 and death is 0.0, mean quality-of-life estimates for living with PTSD were .87±.25, .66±.28, and .64±.20 for SG, TTO, and VAS, respectively. Linear mixed-effects model regression revealed that elicitation method (SG, TTO, and VAS), arousal (a symptom of PTSD), and endorsement of anxiety or depressive symptoms were the strongest predictors of lower quality-of-life scores. Avoidance and re-experiencing of trauma were not predictive of reduced quality of life. Conclusions: Significant decrements in health-related quality of life were found among persons seeking treatment for PTSD. Although arousal and anxiety and depressive symptoms were predictive of quality-of-life estimates, avoidance and re-experiencing were not. These findings identify targets for symptom resolution that may improve quality of life among persons with PTSD. (Psychiatric Services 62:272–277, 2011)

Utility values in Japanese patients with exudative age-related macular degeneration

To investigate the utility values associated with visual loss due to age-related macular degeneration (AMD) in Japanese patients. Utility values in 48 Japanese patients with bilateral exudative AMD were measured using the time trade-off and standard gamble methods. The time trade-off method utility values correlated with the best-corrected visual acuity (BCVA) in the better-seeing eye. The estimated utility values according to the BCVA in the better-seeing eye were 0.534 (BCVA, 0.01-0.15), 0.574 (0.2-0.3), 0.613 (0.4-0.6), and 0.653 (0.7-1.0). The utility values obtained by the standard gamble method were not significantly correlated with BCVA in the better-seeing eye. The present results concur with those of previous studies showing that AMD causes a substantial decrease in patient utility values. The utility values obtained in the current study provide important information for use in cost-utility analysis of interventions for Japanese AMD patients.

Comparison of the quality of life between patients with non-small-cell lung cancer and healthy controls

We explored covariates of the quality of life (QOL) in non-small-cell lung cancer (NSCLC) patients and made a comparison with healthy controls. We assessed the QOL of 220 consecutive NSCLC patients at a university hospital. The QOL data were measured by the brief version of the World Health Organization's Quality of Life and by utility using the standard gamble method. We selected demographically matched healthy controls from the 2001 National Health Interview Survey for comparison. Multiple linear regression models were constructed to explore significant factors of QOL after controlling for covariates. Patients with more advanced stages of NSCLC had poorer scores than did the healthy controls in the physical and psychological domains. Patients with disease duration of longer than 1 year tended to report higher physical and environment QOL than did those with NSCLC diagnosed for less than 1 year. Insight into one's own illness was associated with a higher utility, better social support, and improved financial resources. QOL was significantly associated with staging and duration of NSCLC. Disease insight appears to be a positive factor for operable NSCLC patients of the Taiwanese culture, which implies that clinicians should respect patient autonomy in diagnosis disclosure.

An estimation of the health impact of groundwater pollution caused by dumping of chlorinated solvents

Background Hazardous waste sites are major environmental concerns, but few studies have quantified their expected utility loss on health. Objectives To evaluate the health impact of groundwater pollution by an electronics manufacturing factory, we conducted a health risk assessment based on expected utility loss from liver cancer. Methods Based on measurements of major pollutants, we estimated the likelihood of developing liver cancer after exposure to groundwater contamination. All patients with liver cancer between 1990 and 2005 in the Taiwan Cancer Registry were followed through 2007 using the National Mortality Registry to obtain survival function. Quality of life was assessed with two cross-sectional surveys, one employing the standard gamble method, and the other using the EQ-5D instrument. Quality-adjusted life expectancy (QALE) was estimated by multiplying the utility values with survival function under the unit of quality-adjusted life year (QALY). The difference of QALE between the cancer cohort and the age- and gender-matched reference population was calculated to represent the utility loss due to liver cancer. Results A total of 94,144 patients with liver cancer were identified. The average utility loss to development of liver cancer was 17.5 QALYs. Based on toxicological approach, we estimated that groundwater pollution caused 1.7 extra cases of liver cancer, with an overall loss of 29.8 QALYs. Based on epidemiological approach, the expected annual excess number of liver cancer would be 3.65, which would have been accumulated through the years, had the pollution not mitigated. Conclusions We demonstrated a practical approach for comparative health risk assessment using QALY as the common unit. This approach can be used for policy decisions based on possible health risks.

Is the societal approach wide enough to include relatives?

It is important for economic evaluations in healthcare to cover all relevant information. However, many existing evaluations fall short of this goal, as they fail to include all the costs and effects for the relatives of a disabled or sick individual. The objective of this study was to analyse how relatives’ costs and effects could be measured, valued and incorporated into a cost-effectiveness analysis. In this article, we discuss the theories underlying cost-effectiveness analyses in the healthcare arena; the general conclusion is that it is hard to find theoretical arguments for excluding relatives’ costs and effects if a societal perspective is used. We argue that the cost of informal care should be calculated according to the opportunity cost method. To capture relatives’ effects, we construct a new term, the R-QALY weight, which is defined as the effect on relatives’ QALY weight of being related to a disabled or sick individual. We examine methods for measuring, valuing and incorporating the R-QALY weights. One suggested method is to estimate R-QALYs and incorporate them together with the patient’s QALY in the analysis. However, there is no well established method as yet that can create R-QALY weights. One difficulty with measuring R-QALY weights using existing instruments is that these instruments are rarely focused on relative-related aspects. Even if generic quality-of-life instruments do cover some aspects relevant to relatives and caregivers, they may miss important aspects and potential altruistic preferences. A further development and validation of the existing caregiving instruments used for eliciting utility weights would therefore be beneficial for this area, as would further studies on the use of time trade-off or Standard Gamble methods for valuing R-QALY weights. Another potential method is to use the contingent valuation method to find a monetary value for all the relatives’ costs and effects. Because cost-effectiveness analyses are used for decision making, and this is often achieved by comparing different cost-effectiveness ratios, we argue that it is important to find ways of incorporating all relatives’ costs and effects into the analysis. This may not be necessary for every analysis of every intervention, but for treatments where relatives’ costs and effects are substantial there may be some associated influence on the cost-effectiveness ratio.

Defining the Optimal Treatment for Clinical Stage I Nonseminomatous Germ Cell Testicular Cancer Using Decision Analysis

PURPOSE There is equipoise regarding the optimal treatment of clinical stage (CS) I nonseminomatous germ cell testicular cancer (NSGCT). Formal mechanisms that enable patients to consider cancer outcomes, treatment-related morbidity, and personal preferences are needed to facilitate decision making between retroperitoneal lymph node dissection (RPLND), primary chemotherapy, and surveillance. METHODS Decision analysis was performed using a Markov model that incorporated likelihoods of survival, treatment-related morbidity, and utilities for seven undesired post-treatment health states to estimate the quality-adjusted survival (QAS) for each treatment option. Utilities were obtained from 24 hypothetical NSGCT patients using a visual analog (rating) scale and standard gamble. Results Overall, QAS associated with each treatment was high and differences in QAS were small. Surveillance was the preferred intervention for patients with a risk of relapse less than 33% and 37% using the rating scale and standard-gamble method of utility assessment, respectively. Active treatment was favored over surveillance for patients with relapse risk on surveillance greater than 33% and 37% by the rating scale (RPLND preferred) and standard-gamble methods (primary chemotherapy preferred), respectively. Substantial differences in average utilities were seen depending on the method used. By the rating scale, patients substantially devalued life in six of seven undesired health states but they were surprisingly tolerant of treatment-related morbidity using standard gamble. CONCLUSION A decision model has been developed for CS I NSGCT that estimates QAS for RPLND, primary chemotherapy, and surveillance by considering cancer outcomes, morbidity, and patient preferences. Surveillance was the preferred intervention for all except those patients at high risk for relapse.

Health utility scores of colorectal cancer based on societal preference in Japan

We measured health utility scores of colorectal cancer (CRC) patients from a societal perspective in Japan. Twenty-five states of health were described: four metastatic states without severe adverse events (AEs), 16 metastatic states with Grade 3/4 AEs, four adjuvant states, and one terminal state. A total of 1,500 respondents stratified by age and gender were recruited randomly from the largest Web-panel in Japan. Respondents were allocated randomly to three of the 25 health states and answered questionnaires by standard gamble (SG) and time trade-off (TTO) methods. Although utility scores of metastatic CRC receiving XELOX (capecitabine plus oxaliplatin) chemotherapy were 0.48(SG and TTO) (with stoma) and 0.57(SG) or 0.59(TTO) (without stoma), utility scores of those receiving FOLFOX4 (5-fluorouracil/folinic acid and oxaliplatin) chemotherapy were 0.42(SG) or 0.43(TTO) (with stoma) and 0.52(SG) or 0.53(TTO) (without stoma). These differences between XELOX and FOLFOX4 were statistically significant (P = 0.0198 in SG and P = 0.0059 in TTO). Stage 3/4 AEs decreased utility scores to 0.35-0.4 and 0.4-0.45 in the presence and absence of stoma, respectively. XELOX was generally considered a significantly preferable chemotherapy regimen compared to FOLFOX4 for CRC in Japan. Almost all Grade 3/4 AEs and stoma significantly decreased utility scores. These differences are dependent on the accuracy of the health state description and to confirm these results. In future research, it would be preferable that preference-based HRQoL measures are used directly in patients if utility scores are practically measurable by such method.

Improving Decision Analyses: Parent Preferences (Utility Values) for Pediatric Health Outcomes

To gather and calculate utilities for a wide range of health states in the pediatric population. The study subjects, parents or guardians at least 18 years of age with at least 1 child under age 18 years, were recruited through our Pediatric Research Network (PResNet). Recruitment locations included pediatric clinics, the Indiana State Fair, and public and private conventions. Each subject's utilities were assessed on 3 random health states out of 29 chosen for the study. Both the time trade-off and standard gamble methods were used to measure utilities. Utilities were assessed in a total of 4016 participants (a recruitment rate of 88%). Utility values ranged from a high for acute otitis media (0.96 by standard gamble; 0.97 by time trade-off) to a low for severe mental retardation (0.59 by standard gamble; 0.51 by time trade-off). Our extensive data set of utility assessments for a wide range of disease states can aid future economic evaluations of pediatric health care.

Use of Contingent Valuation to Elicit Willingness-to-Pay for the Benefits of Developmental Health Risk Reductions

We report the results of several contingent valuation (CV) surveys to elicit willingness-to-pay values from the general public for risk reductions associated with decreases in exposure to a chemical, PCBs, in the environment. We also develop Quality Adjusted Life Years (QALYs) from the survey using both standard gamble and time-tradeoff elicitation methods to explore the relationship between QALYs and willingness-to-pay (WTP), and to develop QALY weights for subtle developmental effects. The results of the CV surveys are designed for incorporation into a case study of an integrated risk model to monetize the benefits of predicted risk reductions. Respondents showed a nearly proportional, positive relationship between decreasing the risk of a 6-point reduction in IQ (a standard measure of “intelligence”) and WTP, but showed a negative relationship between risk reduction and WTP for reading comprehension as an outcome. The range of mortality risks that respondents would accept on behalf of their (hypothetical) 10-year-old child is 2 in 10,000 to 9 in 1,000 per IQ point, and WTP per IQ point is $466 ($380, $520). QALY weights elicited via time tradeoff (reduction in life expectancy) were significantly different from QALY weights elicited via a standard gamble (p = 0.001). Respondents who answered questions about ecological endpoints first were willing to pay a small additional amount when asked about human health effects, but those respondents who answered questions about human health endpoints first were not willing to pay any additional amount when subsequently asked about ecological effects.

Utility assessment among patients of primary angle closure/glaucoma in China: a preliminary study

Aim:To evaluate utility values among patients of primary angle closure/glaucoma (PAC/G) in a local hospital in China, and the factors influencing the quality of their lives.Methods:A cross-sectional study. Utility values...

Using Conjoint Analysis to Estimate Healthy-Year Equivalents for Acute Conditions: An Application to Vasomotor Symptoms

Objective Conventional standard gamble and time trade-off methods may be inappropriate for eliciting preferences for some health states because both require subjects to make trade-offs between a morbid health state and death. Thus, the objective of this study is to demonstrate the use of conjoint analysis to obtain time trade-off estimates of healthy-year equivalents (HYEs) for clinically relevant durations and severities of acute, self-limiting, or nonfatal conditions such as vasomotor symptoms. Methods A self-administered, web-enabled, graded-pairs conjoint-analysis survey was developed to elicit women's preferences for reducing the frequency and severity of vasomotor symptoms (daytime hot flushes and night sweats). Observed trade-offs between symptom duration and symptom relief were used to calculate HYEs for different severities and durations of vasomotor symptoms. Results A total of 523 women with a mean age of 52 years completed the survey. For these women, an improvement from severe to moderate vasomotor symptoms yields a gain of 4.44 HYEs, and an improvement from moderate to mild vasomotor symptoms over 1 year yields a gain of 4.62 HYEs over a period of 7 years. HYE gains for symptom relief are larger for younger women than for older women. Conclusions Conjoint analysis is a feasible method for estimating HYEs for acute, self-limiting, or nonfatal conditions. This approach may provide an alternative utility-elicitation method when conventional standard gamble and time trade-off methods are inappropriate to the decision context.

Thrombolytic Treatment for Stroke: Patient Preferences for Treatment, Information, and Involvement

Thrombolytic treatment for stroke carries the potential for a better functional outcome, but also a risk of intracranial hemorrhage and death. Ideally, the decision to treat should be based on the patient's preferences. Study participants were 75 stroke survivors and 75 healthy, age-matched control subjects. We used the Standard Gamble method to elicit utility values for various stroke outcomes. We also assessed patients' preferences for: (1) thrombolytic treatment; (2) the format of information on effects of treatment; and (3) involvement in the decision-making process. Overall, the median utility values were 0.93 (interquartile range [IQR] 0.90-0.96) for a mild stroke, 0.77 (IQR 0.65-0.85) for a moderately severe stroke, and 0.10 (IQR 0.05-0.20) for a severe stroke. Stroke survivors assigned significantly higher utility values than control subjects, as did participants older than 80 years and those who lived with a partner (P < .01). When participants were given the estimates of treatment effect and risk, 9% would have accepted thrombolytic treatment for a mild stroke, 87% for a moderately severe stroke, and 97% for a severe stroke. A majority of the participants (93%) wished to receive detailed information on risks and benefits of thrombolysis, and most (91%) preferred shared patient-doctor decision-making. Preferences for thrombolytic treatment generally increase with increasing stroke severity, but individual factors, such as previous stroke, advanced age, and living conditions can influence the patient's decision. Most patients wanted precise information on the treatment's risks and benefits, and preferred to be actively involved in the decision-making process.

Cost-Effectiveness of Percutaneous Coronary Intervention in Optimally Treated Stable Coronary Patients

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. 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. 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.

Measurement of Utility in Nonmelanoma Skin Cancer

Quality of life is an important variable in assessing the impact of a condition on patients. The current literature shows a minimal effect of nonmelanoma skin cancer (NMSC) on patients' quality of life. This contrasts with our own experience. Given this disparity, we sought to perform an additional study in this area. Past studies have used multiattribute methods to assess quality of life. In contrast, the present study uses health utility methods, which rate a patient's quality of life from 0 to 1, with 1 representing perfect health. Forty-one patients were guided through two standardized scenarios using a standard gamble process with a trained interviewer. Health utility scores were determined for both basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) using various NMSC treatment modalities. All patients had health utility scores of 0.99 or higher. The standard gamble method showed no statistically significant differences in health utility scores for any treatment scenario for BCC or SCC using raw data comparisons. However, a modified standard gamble approach showed significantly higher health utility scores for both BCC and SCC treated using surgical modalities. Using the standard gamble health utility method in patients with BCC or SCC, it appears that these tumors have a minimal impact on the quality of life in the present study group. However, the results may simply reflect the poor sensitivity of the standard gamble health utility method to accurately assess quality of life changes in patients with NMSC. A modification of the standard gamble method did show that patients with NMSC associated surgical treatments with a better health outcome. New outcome measures need to be devised to accurately assess the toll of NMSC on patients.