The relationship between socioeconomic variables and the health-related quality of life (HQL) of children with asthma and their caregivers was examined. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ) were administered to 99 pediatric asthmatic patients and caregivers in two specialty clinics. Sociodemographic data was obtained from medical records and additional questions. The relationship between sociodemographic variables and HQL was determined using multiple linear regression. The mean patient age was 12.6+/-2.1 years, more were male and from a minority race. The mean age of caregivers was 41.2+/-8.5 years; most were female and were fom a minority race. Patients tended to rate their asthma severity as mild to moderate, while caregivers tended to rate patients in the moderate to severe category. Based on prescribed medications, most patients had mild to moderate asthma. Household income was consistently associated with patient-perceived HQL. Less consistent associations were seen with other variables. Household income and the caregiver's perception of asthma severity were associated with all caregiver HQL domains. It was concluded that household income was most consistently associated with the HQL of asthmatic pediatric patients and their caregivers.

Many drug development programs incorporate QoL measures into clinical studies however only a few are accepted into the PI. Despite this study finding, the increased interest in assessing the value and full impact of new therapies has led to greater inclusion of all types of patient assessments in clinical trials.

OBJECTIVE: To assess relative success rates and resource utilization differences between males and females treated to NCEP and EAS cholesterol goals with HMG‐CoA reductase inhibitors. METHODS: In three open‐label clinical trials in the US and Europe, 998 patients (375 females and 623 males) with a CHD risk factor, documented CHD and/or PVD, were randomized to receive one of five HMG‐CoA reductase inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, or simvastatin). Physician visits occurred every 6 weeks and dose titrations (either increased statin dose, or the addition of colestipol or cholestyramine) were made every 12 weeks if target LDL‐C concentration levels were not achieved. The analysis takes a third party perspective by using insurance payment rates for study medications, physician visits, add‐on therapies and treatments for adverse events, all denominated in 1997 US dollars. RESULTS: NCEP or EAS LDL‐C targets were achieved with similar frequency by males (75.7%) and females (74.7%). Accordingly, resource utilization was similar for males and females. Mean total costs were similar for all males ($1529.94) and females ($1470.99, p = 0.776); males ($1280.62) and females ($1252.95, p = 0.665) reaching goal and males ($2306.32) and females ($2115.59, p = 0.103) not reaching goal. Finally, mean total costs for males and females (and respective percentages achieving LDL‐C targets) were similar among study medications: atorvastatin $1044.49 (88.2%) and $1020.29 (90.7%); fluvastatin $1815.03 (58.4%) and $1709.72 (55.5%); lovastatin $2031.78 (77.9%) and $2045.43 (80.3%); pravastatin $1878.90 (53.6%) and $1776.19 (35.7%) and simvastatin $1475.48 (80.3%) and $1293.43 (77.0%). CONCLUSIONS: Successes in achieving LDL‐C targets and resource utilization were independent of gender. However the ability to reach target LDL‐C, by use of specific study medications, significantly impacts the total cost of cholesterol reduction.

OBJECTIVES: Measuring Health‐Related Quality of Life (HRQoL) has become a vital part of assessing pain in international studies. The SF‐MPQ is one of the most widely used tests for the measurement of pain. It consists of 15 descriptors (11 sensory; 4 affective) rated on an intensity scale from 0 (none) to 3 (severe), a Present Pain Intensity (PPI) Index and a visual analogue scale (VAS). Prior to use in international trials the measure underwent linguistic validation in 10 languages. METHODS: A HRQoL specialist coordinated the translation process in each target country using the following methodology: 1) two forward translations by professional translators, native speakers of the target language and fluent in English; 2) comparison and reconciliation of the translations by a HRQoL specialist and translators; 3) backward translation by a native English speaker; 4) comparison of the source and backward versions; 5) comprehension test in a sample target population and finalization. RESULTS: Linguistic and conceptual issues emerged during the translation process. The adjective “aching” was redundant in most languages, equivalents were found such as “discomforting”/“not very intense”. The adjective “tender” used alone was not found descriptive; the equivalent “sensitive to touch” was therefore preferred. The term “punishing” was found to have a strong religious connotation, the notions of “violent” or “torturing” were used instead. Concerning the PPI Index, the terms used to describe pain had an affective component such as “distressing”, “horrible”. An intensity scale was favored in translations. CONCLUSIONS: A rigorous translation methodology of the original SF‐MPQ was performed to ensure conceptual equivalence and acceptability of translations. The issues encountered during linguistic validation highlight the value of international input in instrument design. Future psychometric testing will be conducted to ensure reliability and validity of each translation, appropriateness of the questionnaire in each country, and comparability of data across countries.