Stated-preference methods are a class of evaluation techniques for studying the preferences of patients and other stakeholders. While these methods span a variety of techniques, conjoint-analysis methods-and particularly discrete-choice experiments (DCEs)-have become the most frequently applied approach in health care in recent years. Experimental design is an important stage in the development of such methods, but establishing a consensus on standards is hampered by lack of understanding of available techniques and software. This report builds on the previous ISPOR Conjoint Analysis Task Force Report: Conjoint Analysis Applications in Health-A Checklist: A Report of the ISPOR Good Research Practices for Conjoint Analysis Task Force. This report aims to assist researchers specifically in evaluating alternative approaches to experimental design, a difficult and important element of successful DCEs. While this report does not endorse any specific approach, it does provide a guide for choosing an approach that is appropriate for a particular study. In particular, it provides an overview of the role of experimental designs for the successful implementation of the DCE approach in health care studies, and it provides researchers with an introduction to constructing experimental designs on the basis of study objectives and the statistical model researchers have selected for the study. The report outlines the theoretical requirements for designs that identify choice-model preference parameters and summarizes and compares a number of available approaches for constructing experimental designs. The task-force leadership group met via bimonthly teleconferences and in person at ISPOR meetings in the United States and Europe. An international group of experimental-design experts was consulted during this process to discuss existing approaches for experimental design and to review the task force's draft reports. In addition, ISPOR members contributed to developing a consensus report by submitting written comments during the review process and oral comments during two forum presentations at the ISPOR 16th and 17th Annual International Meetings held in Baltimore (2011) and Washington, DC (2012).
BACKGROUND AND PURPOSE Degenerative changes are commonly found in spine imaging but often occur in pain-free individuals as well as those with back pain. We sought to estimate the prevalence, by age, of common degenerative spine conditions by performing a systematic review studying the prevalence of spine degeneration on imaging in asymptomatic individuals. MATERIALS AND METHODS We performed a systematic review of articles reporting the prevalence of imaging findings (CT or MR imaging) in asymptomatic individuals from published English literature through April 2014. Two reviewers evaluated each manuscript. We selected age groupings by decade (20, 30, 40, 50, 60, 70, 80 years), determining age-specific prevalence estimates. For each imaging finding, we fit a generalized linear mixed-effects model for the age-specific prevalence estimate clustering in the study, adjusting for the midpoint of the reported age interval. RESULTS Thirty-three articles reporting imaging findings for 3110 asymptomatic individuals met our study inclusion criteria. The prevalence of disk degeneration in asymptomatic individuals increased from 37% of 20-year-old individuals to 96% of 80-year-old individuals. Disk bulge prevalence increased from 30% of those 20 years of age to 84% of those 80 years of age. Disk protrusion prevalence increased from 29% of those 20 years of age to 43% of those 80 years of age. The prevalence of annular fissure increased from 19% of those 20 years of age to 29% of those 80 years of age. CONCLUSIONS Imaging findings of spine degeneration are present in high proportions of asymptomatic individuals, increasing with age. Many imaging-based degenerative features are likely part of normal aging and unassociated with pain. These imaging findings must be interpreted in the context of the patient’s clinical condition.
Context Because T-cell interactions are involved in the pathophysiology of psoriasis, therapy with a T-cell modulator may have beneficial effects on psoriasis severity and health-related quality of life (HRQL). Objective To assess the efficacy and safety of efalizumab, a T-cell modulator, in patients with plaque psoriasis. Design, Setting, and Patients Phase 3 randomized, double-blind, parallelgroup, placebo-controlled trial involving 556 adult patients with stable, moderate to severe plaque psoriasis and conducted at 30 study centers in the United States and Canada between January and July 2002. Interventions Patients were randomly assigned in a 2:1 ratio to receive 12 weekly doses of subcutaneous efalizumab, 1 mg/kg (n=369), or placebo equivalent (n=187). Main Outcome Measures At least 75% improvement on the Psoriasis Area and Severity Index (PASI-75); improvement on the overall Dermatology Life Quality Index (DLQI), Itching Visual Analog Scale (VAS), and Psoriasis Symptom Assessment (PSA) at week 12 vs baseline. Results Efalizumab-treated patients experienced significantly greater improvement on all end points than placebo-treated patients. Twenty-seven percent of efalizumabtreated patients achieved PASI-75 vs 4% of the placebo group (PϽ.001). Efalizumabtreated patients exhibited significantly greater mean percentage improvement than placebo-treated patients on the overall DLQI (47% vs 14%; PϽ.001), Itching VAS (38% vs −0.2%; PϽ.001), and PSA frequency and severity subscales (48% vs 18% and 47% vs 17%, respectively; PϽ.001 for both) at the first assessment point. Efalizumab was safe and well tolerated, with primarily mild to moderate adverse events. Conclusion In this 12-week study, efalizumab resulted in significant improvements in clinical end points, including physician-assessed and dermatology-specific patientreported HRQL measures, in patients with moderate to severe plaque psoriasis.
In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.).
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