Journal Article•
Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.
TL;DR: WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials and fulfil conventional criteria for face, content and construct validity, reliability, responsiveness and relative efficiency.
Abstract: Within the context of a double blind randomized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs, we validated WOMAC, a new multidimensional, self-administered health status instrument for patients with osteoarthritis of the hip or knee. The pain, stiffness and physical function subscales fulfil conventional criteria for face, content and construct validity, reliability, responsiveness and relative efficiency. WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials.
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University of Washington1, University of Rochester2, AstraZeneca3, University of Queensland4, Pfizer5, Tufts University6, University of Pennsylvania7, Endo International plc8, University Health Network9, Harvard University10, Purdue Pharma11, Novartis12, National Institutes of Health13, Dalhousie University14, GlaxoSmithKline15, Food and Drug Administration16, Élan17, Abbott Laboratories18, University of California, San Diego19, United States Department of Veterans Affairs20
TL;DR: In this article, the authors provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain, and develop a core set of outcome domains would facilitate comparison and pooling of d
Abstract: Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of d
3,476 citations
TL;DR: The KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction, and can be used to evaluate the course of knee injury and treatment outcome.
Abstract: There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient- centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. In this clinical study, the KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome.
3,003 citations
University of Rochester1, University of Washington2, Saint Louis University3, University of Toronto4, University of Texas MD Anderson Cancer Center5, University of Pennsylvania6, Johns Hopkins University7, Yale University8, National Institutes of Health9, Pfizer10, Food and Drug Administration11, NorthShore University HealthSystem12, Merck & Co.13, Allergan14, University of Copenhagen15, Purdue Pharma16, Celgene17, University of Oxford18, Élan19, GlaxoSmithKline20, Johnson & Johnson21, Duke University22, Oregon Health & Science University23, Endo International plc24, AstraZeneca25
TL;DR: A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments as discussed by the authors.
2,581 citations
University of Rochester1, University of Washington2, University of Pennsylvania3, Johns Hopkins University4, Harvard University5, Yale University6, Ludwig Maximilian University of Munich7, AstraZeneca8, University of Queensland9, Tufts University10, Merck & Co.11, National Institutes of Health12, Endo International plc13, Food and Drug Administration14, University of Toronto15, Purdue Pharma16
2,441 citations
Royal North Shore Hospital1, University of Queensland2, Charité3, University of Melbourne4, University of Sydney5, University of Western Sydney6, University of Lorraine7, University of Adelaide8, Menzies Research Institute9, Monash University10, Deakin University11, Institute for Health Metrics and Evaluation12, Royal Cornwall Hospital13
TL;DR: In this article, the global burden of hip and knee OA was estimated as part of the Global Burden of Disease 2010 study and the burden of OA compared with other conditions.
Abstract: Objective To estimate the global burden of hip and knee osteoarthritis (OA) as part of the Global Burden of Disease 2010 study and to explore how the burden of hip and knee OA compares with other conditions. Methods Systematic reviews were conducted to source age-specific and sex-specific epidemiological data for hip and knee OA prevalence, incidence and mortality risk. The prevalence and incidence of symptomatic, radiographic and self-reported hip or knee OA were included. Three levels of severity were defined to derive disability weights (DWs) and severity distribution (proportion with mild, moderate and severe OA). The prevalence by country and region was multiplied by the severity distribution and the appropriate disability weight to calculate years of life lived with disability (YLDs). As there are no deaths directly attributed to OA, YLDs equate disability-adjusted life years (DALYs). Results Globally, of the 291 conditions, hip and knee OA was ranked as the 11th highest contributor to global disability and 38th highest in DALYs. The global age-standardised prevalence of knee OA was 3.8% (95% uncertainty interval (UI) 3.6% to 4.1%) and hip OA was 0.85% (95% UI 0.74% to 1.02%), with no discernible change from 1990 to 2010. Prevalence was higher in females than males. YLDs for hip and knee OA increased from 10.5 million in 1990 (0.42% of total DALYs) to 17.1 million in 2010 (0.69% of total DALYs). Conclusions Hip and knee OA is one of the leading causes of global disability. Methodological issues within this study make it highly likely that the real burden of OA has been underestimated. With the aging and increasing obesity of the world9s population, health professions need to prepare for a large increase in the demand for health services to treat hip and knee OA.
2,440 citations