Search

Background: Optimizing the validity and responsiveness of utility measures will enhance their usefulness in randomized trials. We evaluated the impact of clinical marker state (CMS) rating prior to patients' rating their own health on two utility instruments (feeling thermometer (FT) and standard gamble (SG)) in patients with chronic respiratory disease (CRD)., Methods: We randomized 182 patients with CRD to complete the FT (self-administered) and SG with CMS (FT+/SG+, n=91) or without marker states (FT-/SG-, n=91) before and after undergoing respiratory rehabilitation in a multi-center trial., Results: Use of CMS did not influence baseline utility scores. Improvement after therapy on the scale from 0 (dead) to 1.0 (full health) was 0.04 both in FT+ (p=0.03) and FT- (p=0.02; the difference between FT+ and FT- was 0.00, p=0.83). Improvement on the SG was 0.05 in both SG+ (p=0.08) and SG- (p=0.04; difference between SG+ and SG- 0.00, p=0.95). Correlations with other health related quality of life scores were highest for FT+., Conclusion: Administration of CMS did not improve responsiveness of the FT but may have improved construct validity. The SG showed limited construct validity and responsiveness that was not influenced by CMS use.

Background: The correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole., Methods: Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables., Results: Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment., Conclusions: Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.

Background: Despite recommendations that patients rating their own health using utility and preference measures such as the feeling thermometer (FT) and standard gamble (SG) should also rate hypothetical marker states, little evidence supports marker state use. We evaluated whether the administration of marker states improves measurement properties of the FT and SG., Methods: We randomized 217 patients with gastroesophageal reflux disease to complete the FT (self-administered) and SG with marker states (FT+ / SG+, n = 112) or without marker states (FT- / SG-, n = 105) before and after 4 weeks of treatment with a proton pump inhibitor, esomeprazole. Patients also completed other health-related quality of life instruments., Results: The use of marker states did not influence baseline utility scores (FT+ 0.66, FT- 0.68; SG+ 0.77, SG- 0.78, on a scale from 0 [dead] to 1.0 [full health]). Improvement after therapy was 0.21 in FT+ and 0.15 in FT- (both P < 0.001; difference between FT+ and FT- = 0.06, P = 0.02). Improvement in SG+ was 0.07 (P < 0.001) and 0.06 in SG- (P = 0.003) (difference between SG+ and SG- = 0.01, P = 0.63). Correlations with other health-related quality of life scores were generally stronger, with some statistically significant differences in correlations, for FT+ compared with FT-, but tended to be weaker for SG+ compared with SG-., Conclusion: The administration of marker states improved the responsiveness and validity of the FT but not of the SG. Decisions about administering marker states should depend on whether the FT and SG is of primary interest and the importance of optimal validity and responsiveness relative to competing objectives such as efficiency.

Background: The correlation between treatment satisfaction and demographic characteristics, symptoms, or healthrelated quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole. Methods: Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables. Results: Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment. Conclusions: Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD. [ABSTRACT FROM AUTHOR]

Background: Gastro-esophageal reflux disease (GERD) is a common disease. It impairs health related quality of life (HRQL). However, the impact on utility scores and work productivity in patients with moderate to severe GERD is not well known. Methods: We analyzed data from 217 patients with moderate to severe GERD (mean age 50, SD 13.7)across 17 Canadian centers. Patients completed three utility instruments - the standard gamble (SG), the feeling thermometer (FT), and the Health Utilities Index 3 (HUI 3) - and several HRQL instruments, including Quality of Life in Reflux and Dyspepsia (QOLRAD) and the Medical Outcomes Short Form-36 (SF-36). All patients received a proton pump inhibitor, esomeprazole 40 mg daily, for four to six weeks. Results: The mean scores on a scale from 0 (dead) to 1 (full health) obtained for the FT, SG, and HUI 3 were 0.67 (95% CI, 0.64 to 0.70), 0.76 (95% CI, 0.75 to 0.80), and 0.80 (95% CI, 0.77 to 0.82) respectively. The mean scores on the SF-36 were lower than the previously reported Canadian and US general population mean scores and work productivity was impaired. Conclusion: GERD has significant impact on utility scores, HRQL, and work productivity in patients with moderate to severe disease. Furthermore, the FT and HUI 3 provide more valid measurements of HRQL in GERD than the SG. After treatment with esomeprazole, patients showed improved HRQL. [ABSTRACT FROM AUTHOR]

Background and study objectives: The chronic respiratory questionnaire (CRQ), a widely used measure of health-related quality of life (HRQL) in patients with chronic airflow limitation, includes an individualized dyspnea domain (patients identify five important activities, and report the degree of dyspnea on a 7-point scale). Because the individualized domain is unwieldy in multicenter clinical trials, we developed a standardized version and tested its discriminative and evaluative properties. Methods: We enrolled 51 patients who completed the standardized and individualized CRQ before starting a respiratory rehabilitation program, and again 3 months later. We calculated both cross-sectional and longitudinal correlations between the two versions and a number of other HRQL instruments, and tested the relative ability of the individualized and standardized versions of the CRQ to detect improvement with rehabilitation. Results: The results of the individualized questions suggested greater dysfunction (lower scores) than did the standardized questions both at baseline (3.18 vs 3.92, p < 0.001) and follow-up (4.62 vs 4.84, p = 0.051). The standardized dyspnea domain showed superior discriminative validity. While both techniques detected important, statistically significant improvement with rehabilitation (individualized domain mean change, 1.44; 95% confidence interval [CI], 1.11 to 1.77 [p < 0.001]; standardized domain mean change, 0.92; 95% CI, 0.61 to 1.24 [p < 0.01]), the difference in effect was substantial and statistically significant (mean difference, 0.52; 95% CI, 0.22 to 0.82; p = 0.001). The two versions showed comparable longitudinal validity. Conclusions: A standardized version of the CRQ dyspnea domain improves the cross-sectional validity, maintains longitudinal validity, but reduces the responsiveness. By increasing sample size, investigators can use the more efficient standardized version of the CRQ without compromising validity. [ABSTRACT FROM AUTHOR]