Relevant baseline characteristics for describing patients with knee osteoarthritis: results from a Delphi survey

BMC Musculoskeletal Disorders

Johann Steurer²  Beat A Michel¹  Maria Wertli²  Anita Hensel²  Lukas M Wildi¹ 

[1] Department of Rheumatology, University Hospital of Zurich, Gloriastrasse 25, 8091 Zurich, Switzerland;Department of Internal Medicine, Horten Centre for Patient-oriented Research and Knowledge Transfer, University of Zurich, Pestalozzistr, 24, 8091 Zurich, Switzerland

关键词: Clinical trial;    Applicability;    Comparability;    Inclusion criteria;    Baseline characteristics;    Knee osteoarthritis;   

Others  :  1128989
DOI  :  10.1186/1471-2474-14-369

 received in 2013-07-16, accepted in 2013-12-19,  发布年份 2013

【 摘 要 】

Background

Inclusion/exclusion criteria and baseline characteristics are essential for assessing the applicability of trial results to a given patient and the comparability of study populations for meta-analyses. This Delphi survey aimed to generate a set of baseline characteristics for describing patients with knee osteoarthritis enrolled in clinical studies.

Methods

Survey participants comprised clinical experts (n = 23; mean age 54 y; from 4 continents) that had authored at least two randomized trials on knee osteoarthritis. First, given a prepared list of baseline patient characteristics, the experts were asked to add characteristics they considered important for assessing comparability of patient populations in different trials that evaluated the efficacy of non-surgical interventions for treating knee osteoarthritis. Next, they were asked to rate the importance of each characteristic, on a scale of 0 (not important) to 10 (highly important), according to three outcome categories: pain, function, and structure.

Results

Participants identified 121 baseline characteristics. A rating ≥7 points was assigned to 39 characteristics (e.g., age, depression, global knee pain, daily dose of pain killers, Kellgren-Lawrence grading); of these, 20 were related to pain, 15 to function, and 23 to structural outcomes. Global knee pain was the only baseline characteristic that fulfilled among experts the predefined consensus criteria.

Conclusions

Experts identified a large number of characteristics for describing patients with knee osteoarthritis. Disagreement and uncertainty prevailed over the relevance of these characteristics. Our findings justified further efforts to define appropriate, broadly acceptable sets of baseline characteristics for describing patients with knee osteoarthritis.

【 授权许可】

   
2013 Wildi et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Cheung PP, Gossec L, Dougados M: What are the best markers for disease progression in osteoarthritis (OA)? Best Pract Res Clin Rheumatol 2010, 24:81-92.
• [2]Centre for Reviews and Dissemination: Systematic Reviews: CRD’s guidance for undertaking reviews in health care. In Book Systematic Reviews: CRD’s guidance for undertaking reviews in health care. York, England: CRD: University of York; 2009.
• [3]Gagnier JJ, Moher D, Boon H, Beyene J, Bombardier C: Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature. BMC Med Res Methodol 2012, 12:111. BioMed Central Full Text
• [4]Higgins JPT, Green S, Cochrane Collaboration: Cochrane handbook for systematic reviews of interventions. Chichester, England: Hoboken, NJ: Wiley-Blackwell; 2008.
• [5]Helg AG: Critical appraisal of the meta-analysis by Wandel et al.- methodological aspects (part 2). BMJ 2010, 12:111.
• [6]Dougados M, Leclaire P, van der Heijde D, Bloch DA, Bellamy N, Altman RD: Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative. Osteoarthritis Cartilage 2000, 8:395-403.
• [7]Manno RL, Bingham CO 3rd, Paternotte S, Gossec L, Halhol H, Giacovelli G, Rovati L, Mazzuca SA, Clegg DO, Shi H, et al.: OARSI-OMERACT initiative: defining thresholds for symptomatic severity and structural changes in disease modifying osteoarthritis drug (DMOAD) clinical trials. Osteoarthritis Cartilage 2012, 20:93-101.
• [8]Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M: OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 2004, 12:389-399.
• [9]Pham T, van der Heijde D, Lassere M, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, et al.: Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol 2003, 30:1648-1654.
• [10]Chapple CM, Nicholson H, Baxter GD, Abbott JH: Patient characteristics that predict progression of knee osteoarthritis: a systematic review of prognostic studies. Arthritis Care Res 2011, 63:1115-1125.
• [11]Oxman AD, Cook DJ, Guyatt GH: Users’ guides to the medical literature. VI. How to use an overview. Evidence-Based Medicine Working Group. JAMA 1994, 272:1367-1371.
• [12]Dalkey NC, Brown BB, Cochran S: The Delphi method. Santa Monica, Calif: Rand Corp; 1969.