Objective The National Institute of Health and Care Excellence (NICE) criteria for osteoarthritis (OA) obviate the need for physical exam or imaging, and their use may improve timely diagnosis of OA. However, they have not been validated. Methods Within a larger study of individuals with type 2 diabetes, participants with and without self‐reported knee pain underwent assessment of the NICE criteria for knee OA by questionnaire (index test), and clinical evaluation for established or possible knee OA by a rheumatologist (reference standard). We calculated the sensitivity, specificity, likelihood ratio positive (LR+) and likelihood ratio negative (LR‐) of the NICE criteria and modified NICE criteria without the stiffness criterion. Results Our study included 96 participants: mean age 65.4 (SD 8.3) years and 52% were women. Individuals who fulfilled NICE criteria for knee OA (55.2%) included a spectrum of pain severity on a 11‐point pain numeric rating scale with a median score of 5 (range: 1‐9). Rheumatologist assessment identified 56 (58.3%) participants with symptomatic knee OA. The sensitivity, specificity, LR+, and LR‐ of NICE criteria for symptomatic knee OA were 0.84 (95% CI 0.74, 0.94), 0.85 (95% CI 0.74, 0.96), 5.6 and 0.19, respectively. For modified NICE criteria, these were 0.89 (95% CI 0.82, 0.97), 0.85 (95% CI 0.74, 0.96), 5.93 and 0.13. Conclusion The NICE criteria have high sensitivity and specificity for detecting symptomatic knee OA in a population with type 2 diabetes. We found that a modified version, omitting the stiffness criterion, performed similarly. These criteria should be validated in other settings and populations.
Background: Hip and knee OA is characterised by disease flares – understanding the determinants and consequences of OA flares has been hampered by lack of a standardized flare measure beyond the pain aspect. The patients point of view on the different aspect of their flares is essential. Objectives: The objective was to assess the psychometric properties of a new questionnaire for measuring the multidimensional aspect of flares in OA. Methods: Using a bilingual version of the questionnaire (33 items, response on a numeric scale, from 0 to 10), a multicentre survey (Australia, France and United States) was conducted on line with patients diagnosed with OA of the hip and/or the knee. Based on an international OMERACT/OARSI endorsed definition of the five core domains (pain, swelling, stiffness, consequences of symptoms and psychological aspects) composing a flare in OA [1], a confirmatory factorial analysis linked to the content analysis has been used to reduce the number of items and to determine the validity of the structure. The Flare-OA questionnaire (score from 0 to 100) has been tested in French and English for its internal consistency, its convergent validity with HOOS/KOOS and Mini-OAKHQOL questionnaires, and its discriminant validity. Results: Out of 398 patients (mean age 64 years old) who completed the questionnaire, 70.4% were female and 86.7% had knee OA. The confirmatory factorial analysis retained a model with 19 items (RMSEA =0.06; SRMR =0.04; CFI =0.96 and TLI = 0.94). The Cronbach Alpha was > 0.9 for the 5 domains and for the whole questionnaire. The correlations between the Flare-OA and the other instruments were in line with that hypothesis flare is related but different from other concepts usually measured. The discriminant validity was evidenced by a significant score difference (31.8; p<0,0001) between patients with and without flare, i.e. over twice the standard measurement error. Conclusion: The optimized Flare-OA questionnaire (19 items) is a reliable and valid instrument freely available from the authors for measuring the frequency and severity of flare in knee and hip OA in clinical research. References: [1]King LK, Epstein J, Cross M, et al. Establishing the Domains of Knee and Hip Osteoarthritis (OA) Flare: A Report from the OMERACT 2020 Inaugural Virtual Consensus Vote from the Flares in OA Working Group. (Submitted) Disclosure of Interests: None declared
The design, analysis, and interpretation of cluster randomized clinical trials (RCTs) require accounting for potential correlation of observations on individuals within the same cluster. Reporting of observed intracluster correlation coefficients (ICCs) in cluster RCTs, as recommended by Consolidated Standards of Reporting Trials (CONSORT), facilitates sample size calculation of future cluster RCTs and understanding of the trial statistical power. Our objective was to summarize observed ICCs in osteoarthritis (OA) cluster RCTs.Systematic review of knee/hip OA cluster RCTs. We searched Cochrane Central Register of Controlled Trials for trials published from 2012, when CONSORT cluster RCTs extension was published, to September 2022. We calculated the proportion of cluster RCTs that reported observed ICCs. Of those that did, we extracted observed ICCs.CRD42022365660.We screened 1121 references and included 20 cluster RCTs. Only 5 trials (25%) reported the observed ICC for at least one outcome variable. ICC values for pain outcomes were: 0, 0.01, 0.18; for physical function outcomes were: 0, 0.06, 0.13 (knee)/0.27 (hip); Western Ontario and McMaster Universities Arthritis Index (WOMAC) total: 0.02, 0.02; symptoms of anxiety/depression: 0.22; disability: 0; and global change: 0. One out of four (25%) trials reported an ICC that was larger than the ICC used for sample size calculation and thus was underpowered.Despite CONSORT statement recommendations for reporting cluster RCTs, few OA trials reported the observed ICC. Given the importance of the ICC to interpretation of trial results and future trial design, this reporting gap warrants attention.
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