Fei-Li Zhao

Validation and Comparison of EuroQol and Short Form 6D in Chronic Prostatitis Patients

OBJECTIVE Generic, preference-based health-related quality of life (HRQoL) instruments is increasingly used in health-care decision-making process. However, to our knowledge, no such HRQoL instrument has been validated or used in chronic prostatitis. We therefore aimed to assess and compare the psychometric properties of EuroQol (EQ-5D) and Short Form 6D (SF-6D) among chronic prostatitis patients in China. METHODS Consenting patients were interviewed using EQ-5D and SF-6D. Convergent and discriminative construct validities were examined with five and two a priori hypotheses, respectively. Sensitivity was compared using receiver operating characteristic (ROC) curves and relative efficiency (RE) statistics. Agreement between instruments was assessed with intra-class correlation coefficients and Bland-Altman plot, while factors affecting utility difference were explored with multiple liner regression models. RESULTS In 268 subjects, mean (SD) EQ-5D and SF-6D utility scores were comparable at 0.73 (0.15) and 0.75 (0.10), respectively. Five of the seven hypotheses for construct validity were fulfilled in both instruments. The areas under ROC of them all exceeded 0.5 (P < 0.001). SF-6D had 9.7-19.9% higher efficiency than EQ-5D at detecting the difference in chronic prostatitis symptom severity. Despite no significant difference in utility scores between two instruments, lack of agreement was observed with low intraclass correlation coefficient (0.218-0.630) and Bland-Altman plot analysis. Chronic prostatitis symptom severity significantly (P < 0.05) influenced differences in utility scores between EQ-5D and SF-6D. CONCLUSIONS Both EQ-5D and SF-6D are demonstrated to be valid and sensitive HRQoL measures in Chinese chronic prostatitis patients, with SF-6D showing better HRQoL dimension coverage, greater sensitivity, lower ceiling effect, and more rational distribution. Further research is needed to determine longitudinal response and reliability.

Clinical efficacy and safety of the newer antiepileptic drugs as adjunctive treatment in adults with refractory partial-onset epilepsy: A meta-analysis of randomized placebo-controlled trials

OBJECTIVE To evaluate the clinical efficacy and safety of the newer antiepileptic drugs (AEDs), namely, Eslicarbazepine (ESL), Retigabine/Ezogabine (RTG), Carisbamate (CAR), Lacosamide (LAC), Brivaracetam (BRI) or Perampanel (PER) as adjunctive therapy for adults with partial-onset seizures (POS). METHODS A systematic review of Randomized placebo-controlled Trials (RCTs) of newer AEDs was conducted. Electronic databases and identified bibliographies were searched to retrieve RCTs. The primary outcomes were responder rates and withdrawal rates, adverse effects. Pooled effects of odds ratio (OR), risk ratio (RR) and risk differences (RD) were derived from meta-analysis implemented in Revmen 5.1. RESULTS In total, 15 RCTs were included. All the studies contained a baseline and treatment phase. The pooled OR of all newer AEDs vs placebo was 2.16 (95% CI: 1.82, 2.57) for responder rates, 1.54 (1.12, 2.10) for withdrawal rates, 1.67 (1.34, 2.08) for adverse effects. The indirect comparisons between individual newer AED and all other newer AEDs suggested the similar results in responder rates (ORs, BRI 1.79 [-1.50, 5.08], RTG 1.41 [0.49, 2.33]). CONCLUSIONS The pooled ORs suggested newer AEDs might be more effective than placebo while with higher incidence of adverse effects. The indirect comparisons suggested BRI, followed by RTG, might be more effective than all other newer AEDs, which could be confirmed by future clinical studies.

Statin is a reasonable treatment option for patients with Polycystic Ovary Syndrome: a meta-analysis of randomized controlled trials

OBJECTIVES To date no consensus has been reached on whether to administer statin to patients with Polycystic Ovary Syndrome (PCOS) routinely. Therefore, we conduct a meta-analysis to synthesize the literatures regarding therapeutic effects of statins on PCOS. METHODS A comprehensive literature search was performed using terms such as polycystic ovary syndrome, ovary polycystic disease, PCOS, hyperandrogaenemia; simvastatin, atorvastatin, lipidemic-modulating drugs, lipid lowering drugs, and testosterone; randomized controlled trials in the following bibliographic databases: Medline, Embase, Cochrane Controlled Trials Register. Identified reference lists were checked manually. RESULTS In total, 4 RCTs were included. 3 of 4 studies were double-blinded while none reported whether of the data was analyzed using intention-to-treat analysis. Serum total testosterone and lipid profiles were included as investigation outcomes. Differences in reducing serum total testosterone were observed when comparing statin with placebo (Std MD= - 3.03, 95%CI - 5.85 ~ - 0.22, P=0.03) or statin + metformin with metformin (Std MD=- 1.07, 95%CI: - 2.06~ - 0.07, P=0.04). Heterogeneities were detected in both comparisons (I2=96% and 88% respectively). Meanwhile, statin was more effective than placebo in reducing LDL (WMD=- 0.87, 95%CI - 1.18~ - 0.55, P<0.0001), TC (WMD=- 1.23 95%CI - 1.35~ - 1.11, P<0.00001), TG (WMD= - 0.50, 95%CI - 0.73~ - 0.27, P<0.00001); and statin + metformin was more effective than metformin in lowering LDL (WMD= - 0.84, 95%CI: - 1.33 ~ - 0.354, P=0.0009), TC (WMD= - 1.28, 95%CI: - 1.47 ~ - 1.10, P<0.00001), and TG (WMD= - 0.27, 95%CI: - 0.36~ - 0.19, P<0.00001). Heterogeneities were detected during the meta-analysis. CONCLUSIONS Statins can reduce the concentration of total testosterone, TC, TG and LDL. However, it cannot be concluded that statins have long-term benefit. A large-scale, randomized controlled study is needed to ascertain this uncertainty.

Can the Direct Medical Cost of Chronic Disease Be Transferred across Different Countries? Using Cost-of-Illness Studies on Type 2 Diabetes, Epilepsy and Schizophrenia as Examples

Objectives To systematically review cost of illness studies for schizophrenia (SC), epilepsy (EP) and type 2 diabetes mellitus (T2DM) and explore the transferability of direct medical cost across countries. Methods A comprehensive literature search was performed to yield studies that estimated direct medical costs. A generalized linear model (GLM) with gamma distribution and log link was utilized to explore the variation in costs that accounted by the included factors. Both parametric (Random-effects model) and non-parametric (Boot-strapping) meta-analyses were performed to pool the converted raw cost data (expressed as percentage of GDP/capita of the country where the study was conducted). Results In total, 93 articles were included (40 studies were for T2DM, 34 studies for EP and 19 studies for SC). Significant variances were detected inter- and intra-disease classes for the direct medical costs. Multivariate analysis identified that GDP/capita (p<0.05) was a significant factor contributing to the large variance in the cost results. Bootstrapping meta-analysis generated more conservative estimations with slightly wider 95% confidence intervals (CI) than the parametric meta-analysis, yielding a mean (95%CI) of 16.43% (11.32, 21.54) for T2DM, 36.17% (22.34, 50.00) for SC and 10.49% (7.86, 13.41) for EP. Conclusions Converting the raw cost data into percentage of GDP/capita of individual country was demonstrated to be a feasible approach to transfer the direct medical cost across countries. The approach from our study to obtain an estimated direct cost value along with the size of specific disease population from each jurisdiction could be used for a quick check on the economic burden of particular disease for countries without such data.

PHP31 WILLINGNESS TO PAY PER QUALITY ADJUSTED LIFE-YEAR: IS ONE THRESHOLD APPLICABLE FOR ALL DECISION-MAKING?

PHP31 WILLINGNESS TO PAY PER QUALITY ADJUSTED LIFE-YEAR: IS ONE THRESHOLD APPLICABLE FOR ALL DECISION-MAKING? Zhao FL, Yue M, Yang H, Wang T, Wu JH, Li SC University of Newcastle, Callaghan, NSW, Australia; 306 Hospital of PLA, Beijing, China; The First People’s Hospital of Yunnan Province, Kunming, Yunnan, China OBJECTIVES: To estimate the Willingness to pay (WTP) per quality-adjusted life-year (QALY) ratio with the stated preference data and compare the results obtained between chronic prostatits (CP) patients and general population. METHODS: CP patients were recruited from two tertiary referral hospitals and the general populations were randomly approached in China at the beginning of 2009. WTP per QALY was calculated with a formula combining the subjects’ own health-related utility and the WTP value. Two widely used preference-based health-related quality of life instruments, EQ-5D and SF-6D, were used to elicit utility for participants’ own health. The monthly WTP values for moving from participants’ current health to a perfect health described by “11111” status of EQ-5D were elicited using closed-ended iterative bidding contingent valuation method. RESULTS: A total of 268 CP patients and 364 participants from general population completed the questionnaire. We obtained four WTP/QALY ratios ranging from

Efficacy and Safety of Thrombin-Receptor Antagonist (Atopaxar and Vorapaxar) in Patients with Acute Coronary Syndrome or Coronary Artery Disease—A Meta-Analysis of Randomized Controlled Trials ☆

4700 to

PIH21 VALIDATION AND COMPARISON OF EUROQOL AND SHORT FORM 6D IN CHINESE CHRONIC PROSTATITIS PATIENTS

7400, which were lower than the proposed thresholds and published researches eliciting the preference for avoiding the risk of death. In addition, the WTP/QALY ratios from the general population were signifi cantly lower than those from the CP patients and different determinants were associated with the within group variation identifi ed by multiple linear regression. CONCLUSIONS: Preference elicitation methods are acceptable and feasible in the socio-cultural context of an Asian environment and the calculation of WTP/QALY produced meaningful answers. The lower WTP/QALY elicited than published values and higher value from CP patients compared with the general population highlight the necessity of considering disease specifi c QALY in estimating WTP/QALY. Our results inferred that one threshold might not be enough to serve all decision-making under different situations. Further studies using the same methods to confi rm whether the WTP/QALY value would be dissimilar among diseases with different impact on QoL would be needed.

Willingness to pay per quality-adjusted life year: is one threshold enough for decision-making?: results from a study in patients with chronic prostatitis

BACKGROUND Meta-analysis for the efficacy and safety data of thrombin-receptor antagonist (TRA) based on patients with acute coronary syndrome (ACS) or coronary artery disease (CAD) and indirect comparisons between TRAs were not available. OBJECTIVES We intended to synthesize the primary end points based on different patient populations (ACS or CAD) as well as perform indirect comparison between two newly invented antiplatelet agents atopaxar and vorapaxar. METHODS A literature search was performed in MEDLINE, Embase, and Cochrane Library. Incidences of major adverse cardiovascular events (MACEs) and bleeding events according to thrombolysis in myocardial infarction were selected as primary outcomes, whereas adverse effects were considered as secondary outcomes. Corresponding results were synthesized using Revman 5.1 according to ACS or CAD cohorts. RESULTS Among the seven included randomized controlled trials, the efficacy end points in the TRA treatment group were favorable compared with placebo. Specifically, the odds ratio (OR) of MACEs was 0.80 (95% confidence interval [CI] 0.52-1.22) for patients with ACS and 0.74 (95% CI 0.53-1.05) for the cohort with CAD. The events of bleeding were unanimously superior in the placebo arm for both cohorts. The indirect comparison showed a superior trend in favor of atopaxar over vorapaxar in occurrences of MACEs (OR 0.93; 95% CI 0.38-1.32), myocardial infarction (OR 0.52; 95% CI 0.13- 0.95), and cardiovascular death (OR 0.82; 95% CI 0.12-4.24) and caused less incidence of bleeding. CONCLUSIONS Besides being more effective than placebo in improving the incidence of MACEs but with a higher risk of bleeding, TRAs may exert different effects in patients with ACS and CAD. Indirect comparisons also suggested that atopaxar might be better than vorapaxar in lowering the incidence of MACEs, myocardial infarction, and cardiovascular death and at the same time with lower risks of bleeding.

Transferability of Indirect Cost of Chronic Disease: A Systematic Review and Meta-Analysis

PIH19 IMPACT OF SEVERITY DIFFERENCES ON LOGICAL INCONSISTENCIES IN VALUES FOR EQ-5D HEALTH STATES Jalundhwala Y, Shaw JW, Pickard AS, Walton S, Busschbach J University of Illinois at Chicago, Chicago, IL, USA, University of Illinois at Chicago, Chicago, IL, USA, Erasmus MC, Rotterdam, The Netherlands OBJECTIVES: The values assigned to EQ-5D health states may be inconsistent with their logical severity. A logical inconsistency occurs when a health state is logically more severe than another but receives a lower value. The objective of this research was to determine whether logical inconsistencies are related to differences in the severity of paired health states. METHODS: One hundred twenty-six Dutch university students used visual analog scales to value the 243 EQ-5D health states. Logical inconsistency rates were estimated for 55 pairs of health states over 1,000 randomly generated vectors of 11 states. Multiple logistic regression was used to model the logical inconsistency of paired health state values as a function of between-state differences in the severity of specific dimensions. RESULTS: Over the 1,000 health state vectors, mean inconsistency rates for paired low-, moderate-, and high-severity states were 0.011, 0.220, and 0.045, respectively. Average inconsistency rates for paired moderate-severity states differed from the average rates for paired low-severity states (p < 0.001) and high-severity states (p < 0.001). For each EQ-5D dimension, the probability of logical inconsistency was positively related to the similarity of the paired states with respect to health problems. The probability of logical inconsistency was higher when both states had moderate or extreme problems in a given dimension than no problems. CONCLUSIONS: The probability of logically inconsistent valuations increases with the similarity of the paired states and is higher when both states are moderately severe than otherwise. These findings have implications for the selection of health states in population-based valuation studies.