Document Detail

Validation of the Knee Injury and Osteoarthritis Outcome Score Subscales for Patients With Articular Cartilage Lesions of the Knee.
MedLine Citation:
PMID:  22962288     Owner:  NLM     Status:  Publisher    
BACKGROUND:The Knee Injury and Osteoarthritis Outcome Score (KOOS) assesses acute and chronic knee injuries or early-onset osteoarthritis in young, active patients. The United States Food and Drug Administration guidelines recommend that patient-reported outcome instruments used to support clinical trial label claims should demonstrate content validity using patient input and have acceptable psychometric properties in the target population. To use the KOOS subscales in safety and efficacy trials assessing new treatments for patients with articular cartilage lesions, additional validation work, using input from patients with articular cartilage lesions, was necessary. PURPOSE:Qualitative and quantitative evaluations of the KOOS subscales' validity among patients with articular cartilage lesions were conducted to support their use as clinically meaningful end points in clinical trials. STUDY DESIGN:Cohort study (diagnosis); Level of evidence, 2. METHODS:For qualitative analysis, cognitive interviews involving concept elicitation and cognitive debriefing with the KOOS items were conducted with 15 participants aged 25 to 52 years. Participants either were candidates for cartilage repair or had undergone cartilage repair 6 months or more before the study. For the quantitative analysis, a psychometric evaluation of the KOOS was conducted with clinical trial data from 54 patients, aged 18 to 55 years, evaluating the Cartilage Autograft Implantation System in the United States (n = 29) and the European Union (n = 25). Data were collected before surgery and at 7 postsurgical visits up to 12 months. Internal consistency and test-retest reliability, construct validity, responsiveness, and estimates of the minimal detectable change (MDC) were assessed. Test-retest reliability was assessed using data from months 2 and 3 on a subset of stable patients. RESULTS:Qualitative research confirmed that concepts measured on the KOOS are important to patients with articular cartilage lesions. Most participants reported the KOOS was comprehensive and appropriate. In the quantitative research, KOOS subscales showed excellent internal consistency reliability (range, .74-.97 at baseline) and test-retest reliability (range, .78-.82). Construct validity results supported hypothesized relationships, with significant correlations (r ≥ .50) in the expected directions. Responsiveness analyses demonstrated excellent sensitivity to change; standardized response means ranged from 0.8 to 1.2, and MDC estimates ranged from 7.4 to 12.1. CONCLUSION:The study results support the use of the KOOS subscales among patients with articular cartilage lesions.
Luella Engelhart; Lauren Nelson; Sandy Lewis; Margaret Mordin; Carla Demuro-Mercon; Sharif Uddin; Lori McLeod; Brian Cole; Jack Farr
Related Documents :
12802748 - Ceftriaxone compared with sodium penicillin g for treatment of severe leptospirosis.
23328688 - Microvascular decompression for classic trigeminal neuralgia: determination of minimum ...
24665238 - Lornoxicam versus tramadol for post-operative pain relief in patients undergoing ent pr...
24262328 - Outcome of standard and high-risk patients with acute anterior circulation stroke after...
7149938 - Conversion of hips with cup arthroplasty to iclh double cup prosthesis.
11990658 - Transient proarrhythmic state following atrioventricular junctional radiofrequency abla...
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-7
Journal Detail:
Title:  The American journal of sports medicine     Volume:  -     ISSN:  1552-3365     ISO Abbreviation:  Am J Sports Med     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7609541     Medline TA:  Am J Sports Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
DePuy Inc, Warsaw, Indiana.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Intense intermittent exercise provides weak stimulus for VEGF secretion and capillary growth in skel...
Next Document:  Reliability of Tunnel Measurements and the Quadrant Method Using Fluoroscopic Radiographs After Ante...