Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a phase II randomized controlled trial.

BACKGROUND: Psoriasis substantially impairs the health-related quality of life (HRQOL) of patients, and a comprehensive evaluation of treatment includes HRQOL measures. OBJECTIVE: To assess the impact of adalimumab on patient-reported outcomes (PROs) of patients with moderate to severe psoriasis. METHODS: In a Phase II, randomized, controlled trial, the efficacy and safety of two dosages of adalimumab (40 mg weekly or every other week) versus placebo were assessed for 12 weeks in the treatment of moderate to severe plaque psoriasis. Patients completed the Dermatology Life Quality Index (DLQI), Short-Form 36 (SF-36) Health Survey, and EuroQOL-5D (EQ-5D) at baseline and 12 weeks. The primary endpoint was the percentage of patients achieving a > or =75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Investigators assessed PASI and Physician's Global Assessment (PGA) scores. RESULTS: Adalimumab patients (either dosage) displayed significantly greater improvements versus placebo patients in DLQI, EQ-5D, and SF-36 Mental Component Summary scores, as well as in Bodily Pain, Vitality, Social Functioning, Role-Emotional, and Mental Health domains. The adalimumab 40-mg weekly group also reported significantly greater improvements in SF-36 Physical Component Summary scores versus the placebo group. CONCLUSION: Both adalimumab dosages were efficacious in improving dermatology-specific and general PROs in patients with moderate to severe psoriasis.

The effect of fexofenadine hydrochloride on productivity and quality of life in patients with chronic idiopathic urticaria.

The present study examined the impact of once-daily fexofenadine hydrochloride (HCl) 180 mg on health-related quality of life (HRQL) in subjects with chronic idiopathic urticaria (CIU). This was a multicenter, randomized, double-blind. parallel-group, placebo-controlled study. Subjects completed the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment (WPAI) questionnaire at baseline and at weeks 2 and 4. The primary HRQL end point was mean change from baseline to week 4 in total DLQI score. Subjects in the fexofenadine HCl treatment group (n = 163) experienced significantly greater improvements in mean total DLQI score (P = .0219) and in the individual domains of symptoms and feelings (P = .0119) and personal relationships (P = .0091) compared with those in the placebo group (n = 91). Subjects who received fexofenadine HCl experienced less work productivity impairment, overall work impairment, and activity impairment than those who received placebo. The results indicated that once-daily fexofenadine HCl 180 mg improved the HRQL of subjects with CIU, as assessed by change in total DLQI score.

The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study.

BACKGROUND: Patient-reported outcome (PROs) measures are being used more frequently in investigational studies of treatments for moderate to severe plaque psoriasis. The objective of this study was to examine the relationships among the Dermatology Life Quality Index (DLQI), the Short Form 36 (SF-36), and the EuroQOL 5D (EQ-5D) and to assess their validity, responsiveness, and estimates of minimum important differences. METHODS: A Phase II, randomized, double-blind, parallel group, placebo-controlled, multi-center clinical trial assessed the clinical efficacy and safety of two doses of subcutaneously administered adalimumab vs. placebo for 12 weeks in the treatment of 147 patients with moderate to severe plaque psoriasis. This study provided the opportunity to evaluate the validity and responsiveness to change in clinical status of PROs instruments. Patients completed the DLQI, SF-36, and EQ-5D questionnaires at baseline and at 12 weeks. Blinded investigators assessed the Psoriasis Area and Severity Index (PASI) scores and the Physician's Global Assessment (PGA) scores of enrolled patients. The responsiveness of the measures to changes in the clinical endpoints from baseline to Week 12 was assessed. Estimates of minimum important differences (MID) were derived. All analyses were performed with blinded data; findings and conclusions were not biased based on treatment condition. RESULTS: The dermatology-specific DLQI was highly correlated to clinical endpoints at baseline and at Week 12, and was the most responsive PRO to changes in endpoints. Compared with the SF-36, the EQ-5D index score and VAS scores were generally more highly correlated with clinical endpoints, but displayed about the same degree of responsiveness. The most responsive SF-36 scales were the Bodily Pain and Social Functioning scales. Estimates of the MID for the DLQI ranged from 2.3-5.7 and for the SF-36 Physical Component Summary (PCS) score ranged from 2.5-3.9. CONCLUSION: This study provides support for the continued use of the DLQI and SF-36 PCS in the assessment of treatments for psoriasis. On the basis of the results from this trial, the EQ-5D should be considered as a general PRO measure in future clinical trials of patients with moderate to severe plaque psoriasis.

Psychometric evaluation of the Osteoporosis Patient Treatment Satisfaction Questionnaire (OPSAT-Q), a novel measure to assess satisfaction with bisphosphonate treatment in postmenopausal women.

BACKGROUND: The Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) is a new measure of patient satisfaction with bisphosphonate treatment for osteoporosis. The objective of this study was to evaluate the psychometric characteristics of the OPSAT-Q. METHODS: The OPSAT-Q contains 16 items in four subscales: Convenience, Confidence with Daily Activities, Side Effects, and Overall Satisfaction. All four subscale scores and an overall composite satisfaction score (CSS) can be computed. The OPSAT-Q, Osteoporosis Targeted Quality of Life (OPTQoL), and sociodemographic/clinical questionnaires, including 3 global items on convenience, functioning and side effects, were self-administered to women with osteoporosis or osteopenia recruited from four US clinics. Analyses included item and scale performance, internal consistency reliability, reproducibility, and construct validity. Reproducibility was measured using the intraclass correlation coefficient (ICC) via a follow-up questionnaire completed by participants 2 weeks post baseline. RESULTS: 104 women with a mean age of 65.1 years participated. The majority were Caucasian (64.4%), living with someone (74%), and not currently employed (58.7%). 73% had osteoporosis and 27% had osteopenia. 80% were taking weekly bisphosphonates and 18% were taking daily medication (2% missing data). On a scale of 0-100, individual patient subscale scores ranged from 17 to 100 and CSS scores ranged from 44 to 100. All scores showed acceptable internal consistency reliability (Cronbach's alpha > 0.70) (range 0.72 to 0.89). Reproducibility ranged from 0.62 (Daily Activities) to 0.79 (Side Effects) for the subscales; reproducibility for the CSS was 0.81. Significant correlations were found between the OPSAT-Q subscales and conceptually similar global measures (p < 0.001). CONCLUSION: The findings from this study confirm the validity and reliability of the OPSAT-Q and support the proposed composition of four subscales and a composite score. They also support the use of the OPSAT-Q to examine the impact of bisphosphonate dosing frequency on patient satisfaction.

An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system.

BACKGROUND: The analgesic effect of long-acting opioids, such as transdermal fentanyl, has been demonstrated in patients with cancer, neuropathic pain and chronic low back pain (CLBP). However, the broader effect of long-acting opioids on the patient's health-related quality of life (HRQoL) is less well known. OBJECTIVE: To evaluate HRQoL outcomes in CLBP patients treated with transdermal fentanyl. RESEARCH DESIGN AND METHODS: An observational study was conducted at 17 clinical centers in the US. Eligible patients had CLBP diagnosis for at least 3 months and were taking short-acting opioids chronically, and then initiated transdermal fentanyl treatment. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF-36 Health Survey, at baseline and > or = 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing CLBP patients' SF-36 scores to the general US population and low back pain patient norms. HRQoL outcomes were determined by comparing baseline and follow-up TOPS and SF-36 scores. Additionally, HRQoL outcomes were evaluated across patient groups stratified by changes in pain intensity ratings as measured by an 11-point numerical rating scale. RESULTS: At baseline CLBP patients (N = 131) scored one-to-two standard deviations (SD) below age and gender adjusted SF-36 general population norms (MANOVA F = 127.1, p < 0.0001) and significantly lower than low back pain norms (MANOVA F = 125.3, p < 0.0001). At follow-up, significant improvement (p < 0.05) was observed on six of the SF-36 scales and both SF-36 summary measures and five of the six TOPS pain-related scales. The magnitude of change in scores in effect size units among these scales ranged from 0.17 to 0.80, which are considered small to large effect size changes. HRQoL score improvement was greatest among patients experiencing the greatest pain relief. CONCLUSION: CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden. Favorable HRQoL outcomes were observed among patients who reported pain relief.

Minimal important difference (MID) of the Dermatology Life Quality Index (DLQI): results from patients with chronic idiopathic urticaria.

BACKGROUND: The Dermatology Quality Life Index (DLQI) has seen widespread use as a health-related quality of life measure for a variety of dermatological diseases. The purpose of this study was to estimate the minimal important difference (MID) on the DLQI for patients with chronic idiopathic urticaria (CIU). METHODS: Data from 2 Phase III clinical trials of patients (N = 476 for Study A; N = 468 for Study B) with CIU were analyzed separately to estimate the MID for the DLQI for these populations. Both distributional based and anchor based approaches were used for deriving estimates. The anchor based approach relied upon patient self assessments of pruritus severity; the distributional based approaches relied upon estimating the standard error of measurement, as well as one-half the standard deviation of the DLQI from each study. RESULTS: The distributional approaches resulted in estimates of MID ranging from 2.24 to 3.10 for the two studies. The anchor based approach resulted in estimates of 3.21 and 2.97 for the two studies. CONCLUSION: An MID for the DLQI in the range of 2.24 to 3.10 is recommended in interpreting results for patients with CIU.

Validity and reliability of patient reported outcomes used in psoriasis: results from two randomized clinical trials.

BACKGROUND: Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. OBJECTIVE: To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials - the Dermatology Life Quality Index (DLQI), the Psoriasis Symptom Assessment (PSA) Scale, and two itch measures, a Visual Analog Scale (VAS) and the National Psoriasis Foundation (NPF) itch measure. METHODS: Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095). Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change) assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. RESULTS: Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. CONCLUSIONS: The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology-related limitations of functional ability and the frequency, severity and impact of psoriasis symptoms on patients' lives and psoriasis-related quality of life.

Development of the Health and Work Questionnaire (HWQ): an instrument for assessing workplace productivity in relation to worker health.

BACKGROUND: Workplace productivity evaluations often involve subjective assessments. This study was performed to develop and validate a new multidimensional instrument, the Health and Work Questionnaire (HWQ), for measuring workplace productivity and worker heath. METHODS: In a prospective, non-randomized study, objective and subjective workplace productivity (measured with the HWQ) was assessed among 96 current, 94 former, and 104 non-smoking volunteer reservation agents at a US-based international airline. RESULTS: Six HWQ sub-scales were identified from factor analyses: productivity, concentration/focus, supervisor relations, impatience/irritability, work satisfaction, and non-work satisfaction. Non-smokers (individuals who had never smoked) had higher scores on all scales. The HWQ scale scores all correlated significantly with the objective measure "Time Lost"; two of the scales correlated significantly with the summary objective performance measure. Magnitudes of the significant correlations were modest (0.12 to 0.22). CONCLUSIONS: The HWQ may be useful for evaluating the impact of interventions on workplace productivity. Additional validation research on the HWQ is recommended before use as a primary measure in studies of worker productivity.

Development and evaluation of a measure to assess restorative sleep.

BACKGROUND: There are validated measures assessing insomnia and disturbed sleep, but few psychometrically sound instruments to assess perceptions of the restorative or inadequate properties of sleep are available. STUDY OBJECTIVES: To develop and evaluate a new instrument, the Restorative Sleep Questionnaire (RSQ). DESIGN AND SETTING: Focus groups were conducted using participants with and without nonrestorative sleep complaints. Questions were designed to elicit the feelings and experiences people have about their sleep and their view of daytime consequences of sleep. Expert panels confirmed the importance of nonrestorative sleep (NRS) as a frequently encountered problem either with or without other sleep complaints. The resulting RSQ was administered in three studies: (1) a telephone interview with healthy controls and individuals with sleep problems; (2) a randomized clinical trial of patients with primary insomnia assessed by polysomnography (PSG); (3) a PSG study of subjects with NRS complaints. MEASUREMENT AND RESULTS: Across all studies, the new measures were shown to be significantly correlated with health-related quality of life (HRQL) domains hypothesized to be related to NRS. The RSQ had good psychometric properties (α > 0.90; rtest-retest > 0.80), and factor analysis confirmed the unidimensionality of the measure. The RSQ was able to distinguish between healthy controls, patients with primary insomnia, and insomnia patients with isolated NRS complaints but without PSG defined sleep onset, duration, or maintenance problems. Normal sleepers reported sleep that was about a standard deviation more restorative than that of those with NRS on the RSQ. CONCLUSIONS: The results of the study provide support for the reliability and validity of the RSQ as a measure of NRS in subjects with and without self-reported or PSG confirmed sleep initiation and maintenance difficulties. CLINICALTRIALSGOV IDENTIFIERS: NCT00655369; NCT00705601.

Development and validation of the Gastroesophageal Reflux Disease Treatment Satisfaction Questionnaire.

There is growing recognition of the importance of assessing patient perceptions of treatment, especially patient satisfaction. The Gastroesophageal Reflux Disease (GERD) Treatment Satisfaction Questionnaire (GTSQ) was developed to assess satisfaction with GERD medication. A web-based survey, which included the GTSQ and the GERD Symptom Assessment Scale (GSAS), was administered in September 2003 to 2511 subjects taking prescription GERD medication, identified as H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). Results showed excellent reliability of the GTSQ subscales (from 0.82-0.95) and validity with respect to two GSAS subscales. Rabeprazole (Aciphex) subjects taking 1 pill per day were statistically more satisfied than those taking 2 pills per day for all subscales except "Daytime Relief" and "Quick and Long-Lasting." Those who stayed on rabeprazole therapy longer showed statistically significant greater satisfaction on the "Daytime Relief" and "Health-Related Quality of Life" scales. The GTSQ has high reliability and can be used to assess aspects of satisfaction with GERD medication.

Student and Faculty Perceptions of Teacher Characteristics.

Both faculty and students are interested in faculty becoming better teachers. But do both students and faculty have the same perceptions of teacher characteristics? The present study attempted to answer this question by having 15 faculty members and 22 undergraduate students perform similarity judgments between each possible pair of 14 teacher types. An individual differences multidimensional scaling analysis and a post hoc analysis indicated that faculty and students had the same perceptions of teacher characteristics.

Satisfaction with medication: an overview of conceptual, methodologic, and regulatory issues.

OBJECTIVE: Patients' satisfaction with their medication or medical device has been of increasing interest over the past decade. This is reflective of the rise of the patient as consumer and the desire of pharmaceutical and device manufacturers to obtain feedback from the consumers about their products. Satisfaction with medication is more narrowly focused and should be distinguished from other aspects of satisfaction. The purpose of this article is to place the concept of patient satisfaction with medication in an appropriate theoretical context, to explore the challenges of performing this research, and to offer recommendations for the basis of satisfaction claims. METHODS: We reviewed the literature on satisfaction with medication or medical devices. We summarize and discuss the background, conceptual issues, and theoretical justification for studying satisfaction with medication. We offer examples of domains to be included and suggestions on how to develop a psychometrically sound satisfaction measure. We also address additional issues for consideration. RESULTS: Medication satisfaction is a type of patient-reported outcome, but is distinguished from other patient-reported outcomes-specifically health-related quality of life (HRQL) and self-reports of symptoms. The Theory of Reasoned Action provides one theoretical justification for the concept. The heuristic value of this theory leads to implications regarding the relation between satisfaction and adherence. In addition, the theory is consistent with the need to focus on the patient's beliefs and values concerning the impact of taking his/her medication. Although the beliefs will differ according to the specific drug-disease combination, the beliefs can often be categorized in several domains of satisfaction: symptom relief/efficacy, side effects, ease and convenience, impact on HRQL, general satisfaction, and additional domains specific to the given research question. CONCLUSION: Patient satisfaction instruments should be subjected to the same psychometrically rigorous standards and procedures as any other patient-reported outcome and should also be subject to the same regulatory standards as other patient-reported outcomes with respect to advertising and promotion.