Development and validation of the Flare-OA questionnaire for measuring flare in knee and hip osteoarthritis.

OBJECTIVE: Ability to assess flares in osteoarthritis (OA) of the knee and hip (KHOA) is important in clinical care and research. Using mixed methods, we developed a self-reported instrument measuring flare and assessed its psychometric properties. METHODS: We constructed questionnaire items from semi-structured interviews and a focus group (patients, clinicians) by using a dual-language (English-French) approach. A Delphi consensus method was used to select the most relevant items. Patients with OA from Australia, France and the United States completed the preliminary Flare-OA, HOOS, KOOS and Mini-OAKHQOL questionnaires online. We used a factor analysis and content approach to reduce items and determine structural validity. We tested the resulting questionnaire (score 0-100) for internal consistency, convergent and known-groups validity. RESULTS: Initially, 180 statements were generated and reduced to 33 items in five domains (response 0 = not at all, to 10 = absolutely) by Delphi consensus (50 patients, 116 professionals) and an expert meeting. After 398 patients (mean [SD] age 64 [8.5] years, 70.4% female, 86.7% knee OA) completed the questionnaire, it was reduced to 19 items by factor analysis and a content approach (RMSEA = 0.06; CFI = 0.96; TLI = 0.94). The Cronbach's alpha was >0.9 for the five domains and the whole questionnaire. Correlation coefficients between Flare-OA and other instrument scores were as predicted, supporting construct validity. The difference in Flare-OA score between patients with and without flare (31.8) largely exceeded 2 SEM (10.2). CONCLUSION: Flare-OA is a valid and reliable patient-reported instrument for assessing the occurrence and severity of flare in patients with KHOA in clinical research.

Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.

OBJECTIVE: This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN: 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS: The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS: The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.

Factors associated with the orthopaedic surgeon's decision to recommend total joint replacement in hip and knee osteoarthritis: an international cross-sectional study of 1905 patients.

OBJECTIVE: To determine factors associated with orthopaedic surgeons' decision to recommend total joint replacement (TJR) in people with knee and hip osteoarthritis (OA). DESIGN: Cross-sectional study in eleven countries. For consecutive outpatients with definite hip or knee OA consulting an orthopaedic surgeon, the surgeon's indication of TJR was collected, as well as patients' characteristics including comorbidities and social situation, OA symptom duration, pain, stiffness and function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), joint-specific quality of life, Osteoarthritis Research Society International (OARSI) joint space narrowing (JSN) radiographic grade (0-4), and surgeons' characteristics. Univariable and multivariable logistic regressions were performed to identify factors associated with the indication of TJR, adjusted by country. RESULTS: In total, 1905 patients were included: mean age was 66.5 (standard deviation [SD], 10.8) years, 1082 (58.0%) were women, mean OA symptom duration was 5.0 (SD 7.0) years. TJR was recommended in 561/1127 (49.8%) knee OA and 542/778 (69.7%) hip OA patients. In multivariable analysis on 516 patients with complete data, the variables associated with TJR indication were radiographic grade (Odds Ratio, OR for one grade increase, for knee and hip OA, respectively: 2.90, 95% confidence interval [1.69-4.97] and 3.30 [2.17-5.03]) and WOMAC total score (OR for 10 points increase: 1.65 [1.32-2.06] and 1.38 [1.15-1.66], respectively). After excluding radiographic grade from the analyses, on 1265 patients, greater WOMAC total score was the main predictor for knee and hip OA; older age was also significant for knee OA. CONCLUSION: Radiographic severity and patient-reported pain and function play a major role in surgeons' recommendation for TJR.

Cross-cultural validation of the ICOAP and physical function short forms of the HOOS and KOOS in a multi-country study of patients with hip and knee osteoarthritis.

OBJECTIVE: To evaluate the internal consistency and construct validity of the Physical Function short-forms for the Hip and Knee Injury Osteoarthritis Outcome Scores (HOOS-PS/KOOS-PS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) in a nine country study of patients consulting for total hip or knee replacement (THR or TKR). METHODS: Patients completed HOOS-PS or KOOS-PS, ICOAP and Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC) pain and physical function subscales at their consultation visit. Internal consistency was calculated using Cronbach's alpha. The association of HOOS-PS/KOOS-PS and ICOAP with WOMAC pain and function subscales was calculated with Spearman correlation coefficients with 95% confidence intervals. RESULTS: HOOS-PS/KOOS-PS and ICOAP demonstrated high internal consistency across countries (alpha 0.75-0.96 (hip) and 0.76-0.95 (knee)). Both HOOS-PS and KOOS-PS demonstrated high correlations (0.76-0.90 and 0.75-0.91, respectively) with WOMAC function in all countries. ICOAP exhibited moderate to high correlations with WOMAC pain and function subscales (0.53-0.84 (hip) and 0.43-0.84 (knee)). CONCLUSION: The psychometric properties of the HOOS-PS/KOOS-PS, and ICOAP were maintained across all countries.

Test-retest reliability and responsiveness of centre of pressure measurements in patients with hip osteoarthritis.

OBJECTIVE: The aim of this study was to determine a set of measures for the evaluation of balance in patients suffering from hip osteoarthritis (OA) that were both reliable and responsive to change. DESIGN: Three groups of subjects; Healthy, hip OA patients without surgery, and hip OA with surgery (pre and post-surgery) were included in this study. Subjects had to perform balance tests in two positions: standard and narrowed stance. CoP-based measures test-retest reliability was assessed in hip OA without surgery group, responsiveness were assessed between all groups and between pre and post-surgery. RESULTS: Intraclass Correlation Coefficient (ICC) values from hip OA without surgery ranged from -0.03 to 0.9 for only five parameters (CoP path length, SD velocity, mean velocity, and antero-posterior Root Mean Square (RMS(AP)) having values over 0.7. SD velocity and RMS(AP) showed significant differences between healthy and surgery group in standard stance whereas narrowed stance revealed most differences between all groups. RMS(AP) showed the best responsiveness (Standardized Response Mean ∼0.5) between pre vs post-surgery in both conditions. RMS(AP) was also capable of discriminating between hip OA with surgery vs without surgery groups with good sensitivity and specificity. CONCLUSIONS: Our results showed there to be reliability and responsiveness of five postural parameters in hip OA patients in two conditions of standing balance. More parameters were significantly different in narrowed stance whereas sensitivity was better in standard stance. SD velocity and RMS(AP) discriminate between degrees of OA severity and highlight potential balance deficits even after arthroplasty. Selected parameters during standing balance could be assessed to complete the set of quantitative measures to quantify hip OA patient deficiencies.

Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group.

OBJECTIVE: The Osteoarthritis Research Society International initiated a number of working groups to address a call from the US Food and Drug Administration (FDA) on updating draft guidance on conduct of osteoarthritis (OA) clinical trials. The development of disease-modifying osteoarthritis drugs (DMOADs) remains challenging. The Assessment of Structural Change (ASC) Working Group aimed to provide a state-of-the-art critical update on imaging tools for OA clinical trials. METHODS: The Group focussed on the performance metrics of conventional radiographs (CR) and magnetic resonance imaging (MRI), performing systematic literature reviews for these modalities. After acquiring these reviews, summary and research recommendations were developed through a consensus process. RESULTS: For CR, there is some evidence for construct and predictive validity, with good evidence for reliability and responsiveness of metric measurement of joint space width (JSW). Trials off at least 1 and probably 2 years duration will be required. Although there is much less evidence for hip JSW, it may provide greater responsiveness than knee JSW. For MRI cartilage morphometry in knee OA, there is some evidence for construct and predictive validity, with good evidence for reliability and responsiveness. The responsiveness of semi-quantitative MRI assessment of cartilage morphology, bone marrow lesions and synovitis was also good in knee OA. CONCLUSIONS: Radiographic JSW is still a recommended option for trials of structure modification, with the understanding that the construct represents a number of pathologies and trial duration may be long. MRI is now recommended for clinical trials in terms of cartilage morphology assessment. It is important to study all the joint tissues of the OA joint and the literature is growing on MRI quantification (and its responsiveness) of non-cartilage features. The research recommendations provided will focus researchers on important issues such as determining how structural change within the relatively short duration of a trial reflects long-term change in patient-centred outcomes.

Test-retest reliability of 3D kinematic gait variables in hip osteoarthritis patients.

OBJECTIVES: (1) to investigate the test-retest reliability of 3D gait analysis (3DGA) in hip Osteoarthritis (OA) patients; (2) to find the minimum number of gait trials needed to overcome intrinsic variability; (3) to check the accuracy of angles measured by the 3D system. DESIGN: 23 Patients suffering from hip OA with no other major disease were recruited. We evaluated the reliability of spatio-temporal variables and body angles (lower-limb joints, trunk and pelvis angles) during two sessions of 3DGA using intra-class correlation coefficients (ICC). The minimum number of trials needed to overcome intrinsic variability was evaluated using an exponential fit model and the Bland and Altman coefficient of repeatability (CoR). The accuracy of measurement was evaluated using a manual goniometer and the recording of 18 different angles. RESULTS: Spatio-temporal variables and most of the kinematic joint and trunk angles calculated demonstrated good to excellent reliability (ICC from 0.77 to 0.97). This was not the case for pelvic angles. The fitting model combined with the CoR showed that 5-10 trials are sufficient to obtain good reliability [ICC>0.7; CoR<2 standard deviation (SD)] for most of the spatio-temporal variables. All body angles showed good reliability (ICC>0.7) and low CoR (<2 SD) after five trials except for the pelvic angles. The reliability of marker positioning was found to be good (ICC>0.7) to excellent (ICC>0.9). Differences between angles measured using 3DGA and angles measured with a manual goniometer were found to be less than one percent. CONCLUSION: The present study shows that most of variables obtained using 3DGA in hip OA patients are reliable. Moreover, for most variables, 5-10 trials are needed to obtain good reliability and to overcome intrinsic variability, rather than 30 or more, thus improving the feasibility of measurement.

Validity and responsiveness of radiographic joint space width metric measurement in hip osteoarthritis: a systematic review.

AIM: To perform a systematic review of the literature on the concurrent validity, predictive validity and responsiveness of radiographic metric measurement of femoro-acetabular joint space width (JSW) in hip osteoarthritis (OA). ELIGIBILITY CRITERIA: studies reporting any data on (1) JSW on X-rays in hip OA patients and (2) concurrent validity (correlations with clinical symptoms), predictive validity (correlations with future symptomatic state, joint space loss or joint replacement), and/or responsiveness (JSW change over time evaluated using the standardized response mean (SRM)). SEARCH STRATEGY: Medline PUBMED and Embase databases. STATISTICAL ANALYSIS: Random-effects models were constructed to obtain pooled SRMs. RESULTS: Of 448 articles, 79 met the abstract inclusion criteria and were read for further screening. Of these, 15 reported measures of validity and 11 reported measures of responsiveness. Concurrent validity: Five studies suggested an association between JSW and symptoms in the general population. Two evaluated the correlations between JSW and symptoms in hip OA patients, with conflicting results. Five demonstrated that JSW is predictive of future hip joint replacement. Responsiveness was moderate (SRM=0.66; 95% confidential interval (95%CI): 0.41, 0.91), but tended to be lower in randomized clinical trials than in cohort studies (0.35 vs 0.83), using an intention to treat rather than a completer analysis (0.30 vs 0.80), and using manual rather than computer-based measurement (0.47 vs 1.12). CONCLUSION: There is evidence of a weak association between JSW and symptoms, of predictive validity for subsequent joint replacement, and of moderate responsiveness of metric measurement of JSW.

Responsiveness to change and reliability of measurement of radiographic joint space width in osteoarthritis of the knee: a systematic review.

OBJECTIVE: The goal of this systematic review was to report the responsiveness to change and reliability of conventional radiographic joint space width (JSW) measurement. METHOD: We searched the PubMed and Embase databases using the following search criteria: [osteoarthritis (OA) (MeSH)] AND (knee) AND (X-ray OR radiography OR diagnostic imaging OR radiology OR disease progression) AND (joint space OR JSW or disease progression). We assessed responsiveness by calculating the standardized response mean (SRM). We assessed reliability using intra- and inter-reader intra-class correlation (ICC) and coefficient of variation (CV). Random-effects models were used to pool results from multiple studies. Results were stratified by study duration, design, techniques of obtaining radiographs, and measurement method. RESULTS: We identified 998 articles using the search terms. Of these, 32 articles (43 estimates) reported data on responsiveness of JSW measurement and 24 (50 estimates) articles reported data on measures of reliability. The overall pooled SRM was 0.33 [95% confidence interval (CI): 0.26, 0.41]. Responsiveness of change in JSW measurement was improved substantially in studies of greater than 2 years duration (0.57). Further stratifying this result in studies of greater than 2 years duration, radiographs obtained with the knee in a flexed position yielded an SRM of 0.71. Pooled intra-reader ICC was estimated at 0.97 (95% CI: 0.92, 1.00) and the intra-reader CV estimated at 3.0 (95% CI: 2.0, 4.0). Pooled inter-reader ICC was estimated at 0.93 (95% CI: 0.86, 0.99) and the inter-reader CV estimated at 3.4% (95% CI: 1.3%, 5.5%). CONCLUSIONS: Measurement of JSW obtained from radiographs in persons with knee is reliable. These data will be useful to clinicians who are planning RCTs where the change in minimum JSW is the outcome of interest.

The role of pain and functional impairment in the decision to recommend total joint replacement in hip and knee osteoarthritis: an international cross-sectional study of 1909 patients. Report of the OARSI-OMERACT Task Force on total joint replacement.

OBJECTIVE: To assess the pain and functional disability levels corresponding to an indication for total joint replacement (TJR) in hip and knee osteoarthritis (OA). DESIGN: International cross-sectional study in 10 countries. PATIENTS: Consecutive outpatients with definite hip or knee OA attending an orthopaedic outpatient clinic. Gold standard measure for recommendation for TJR: Surgeon's decision that TJR is justified. OUTCOME MEASURES: Pain (ICOAP: intermittent and constant osteoarthritis pain, 0-100) and functional impairment (HOOS-PS/KOOS-PS: Hip/Knee injury and Osteoarthritis Outcome Score Physical function Short-form, 0-100). ANALYSES: Comparison of patients with vs without surgeons' indication for TJR. Receiver Operating Characteristic (ROC) curve analyses and logistic regression were applied to determine cut points of pain and disability defining recommendation for TJR. RESULTS: In all, 1909 patients were included (1130 knee/779 hip OA). Mean age was 66.4 [standard deviation (SD) 10.9] years, 58.1% were women; 628/1130 (55.6%) knee OA and 574/779 (73.7%) hip OA patients were recommended for TJR. Although patients recommended for TJR (yes vs no) had worse symptom levels [pain, 55.5 (95% confidence interval 54.2, 56.8) vs. 44.9 (43.2, 46.6), and functional impairment, 59.8 (58.7, 60.9) vs. 50.9 (49.3, 52.4), respectively, both P<0.0001], there was substantial overlap in symptom levels between groups, even when adjusting for radiographic joint status. Thus, it was not possible to determine cut points for pain and function defining 'requirement for TJR'. CONCLUSION: Although symptom levels were higher in patients recommended for TJR, pain and functional disability alone did not discriminate between those who were and were not considered to need TJR by the orthopaedic surgeon.

Cross-cultural adaptation and validation of the French version of the Hip disability and Osteoarthritis Outcome Score (HOOS) in hip osteoarthritis patients.

OBJECTIVE: To translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into French and to evaluate the psychometric properties of this new version, by testing feasibility, internal consistency, construct validity, reliability and responsiveness, in patients with hip osteoarthritis (OA). METHODS: The French version of the HOOS was developed according to published international guidelines to ensure content validity. The new version was then evaluated in two symptomatic hip OA populations, one with no indication for joint replacement (medical group), and the other waiting for total hip replacement (THR) (surgery group). The psychometric properties assessed were feasibility: percentage of responses, floor and ceiling effects; internal consistency using Cronbach's alpha; construct validity by evaluating correlations with the Lequesne's index and the visual analogic scale (VAS) for pain (Pearson's correlation coefficient); reliability: intra-class correlation coefficient (ICC), Bland et Altman representation; responsiveness by comparing the results of before and 1 month after injection of hyaluronic acid (medical group) and by comparing the pre and 3 months post THR results (surgery group) by calculating standardized response mean (SRM) and effect size (ES). RESULTS: A total of 88 patients were recruited; 58 in the medicine group (mean age=61.8+/-9 years, range 42-81, 70% women) and 30 in the surgery group (mean age=67.5+/-9 years, range 50-81, 68% women). The percentage of item responses was excellent (99%). Neither a floor nor a ceiling effect was observed, except for a ceiling effect (17.8% of patients with worst possible score) observed prior to surgery in the sport and recreation subscale. The internal consistency was good for four of the five HOOS subscales. As expected, the strongest correlations were observed between all HOOS subscales and Lequesne's index or VAS pain, indicating good construct validity. The reliability was good, with an ICC>0.8 for all subscales. The responsiveness was good for all domains 1 month after hyaluronic acid injection (ES ranging from 0.73 to 1.86 and SRM from 0.51 to 1.04) and high for all domains 3 months after THR (ES ranging from 1.47 to 2.08 and SRM ranging from 1.97 to 3.24). CONCLUSION: The French version of HOOS demonstrated good psychometric properties and appears to be useful for the evaluation of patient-relevant outcome whatever the severity of hip OA. This study provides a basis for the use of this French version of the HOOS in future clinical trials.

Aspartame-induced fibromyalgia, an unusual but curable cause of chronic pain.

We report for the first time an unusual musculoskeletal adverse effect of aspartame in two patients. A 50-year-old woman had been suffering from widespread pain and fatigue for more than 10 years leading to the diagnosis of fibromyalgia. During a vacation in a foreign country, she did not suffer from painful symptoms since she had forgotten to take her aspartame. All of the symptoms reappeared in the days following her return when she reintroduced aspartame into her daily diet. Thus, aspartame was definitively excluded from her diet, resulting in a complete regression of the fibromyalgia symptoms. A 43-year-old man consulted for a 3-year history of bilateral forearm, wrist, and hand and cervical pain with various unsuccessful treatments. A detailed questioning allowed to find out that he had been taking aspartame for three years. The removal of aspartame was followed by a complete regression of pain, without recurrence. We believe that these patients' chronic pain was due to the ingestion of aspartame, a potent flavouring agent, widely used in food as a calorie-saver. The benefit/ risk ratio of considering the diagnosis of aspartame-induced chronic pain is obvious: the potential benefit is to cure a disabling chronic disease, to spare numerous laboratory and imaging investigations, and to avoid potentially harmful therapies; the potential risk is to temporarily change the patient's diet. Thus, practitioners should ask patients suffering from fibromyalgia about their intake of aspartame. In some cases, this simple question might lead to the resolution of a disabling chronic disease.

Cross-cultural adaptation and validation of the French version of the Rheumatoid and Arthritis Outcome Score (RAOS).

OBJECTIVES: The Rheumatoid and Arthritis Outcome Score (RAOS) was recently developed to evaluate functional disability and quality of life in rheumatoid arthritis (RA) patients suffering from lower limb symptoms. The aims of this study were to cross-culturally adapt the RAOS into French and to assess its psychometric properties, in particular, responsiveness following intra-articular therapy. METHODS: The French RAOS was developed according to cross-cultural guidelines and was then evaluated in symptomatic RA patients with lower limb joint involvement. The psychometric properties assessed were - feasibility: percentage of missing data and floor and ceiling effects; reliability: intra-class correlation coefficients (ICC, and Bland and Altman representation; internal consistency: Cronbach's alpha; construct validity by correlation with the SF-36 and HAQ (Spearman's rank test); responsiveness to intra-articular corticosteroid injection (hip, knee, hindfoot) using standardised response mean (SRM) and effect size. RESULTS: Sixty patients were included (mean age 50.1±10.5 years). Neither floor nor ceiling effects were observed. Reliability was good with ICC for different RAOS subscales ranging from 0.76 to 0.91. Results for internal consistency (Cronbach's alpha ranging from 0.73 to 0.91) and construct validity were good. The responsiveness was moderate to large with SRMs ranging from 0.75 to 0.87 and effect sizes from 0.77 to 1.75 at two weeks following intra-articular corticosteroid injection. CONCLUSIONS: The French version of the RAOS demonstrated good psychometric properties to capture functional disability and quality of life in RA. Moreover, the results suggest that the RAOS could be used as an outcome in trials evaluating single joint intra-articular injections.

Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST-RA database.

OBJECTIVE: To analyse associations between the clinical status of patients with rheumatoid arthritis (RA) and the gross domestic product (GDP) of their resident country. METHODS: The Quantitative Standard Monitoring of Patients with Rheumatoid Arthritis (QUEST-RA) cohort includes clinical and questionnaire data from 6004 patients who were seen in usual care at 70 rheumatology clinics in 25 countries as of April 2008, including 18 European countries. Demographic variables, clinical characteristics, RA disease activity measures, including the disease activity score in 28 joints (DAS28), and treatment-related variables were analysed according to GDP per capita, including 14 "high GDP" countries with GDP per capita greater than US$24,000 and 11 "low GDP" countries with GDP per capita less than US$11,000. RESULTS: Disease activity DAS28 ranged between 3.1 and 6.0 among the 25 countries and was significantly associated with GDP (r = -0.78, 95% CI -0.56 to -0.90, r(2) = 61%). Disease activity levels differed substantially between "high GDP" and "low GDP" countries at much greater levels than according to whether patients were currently taking or not taking methotrexate, prednisone and/or biological agents. CONCLUSIONS: The clinical status of patients with RA was correlated significantly with GDP among 25 mostly European countries according to all disease measures, associated only modestly with the current use of antirheumatic medications. The burden of arthritis appears substantially greater in "low GDP" than in "high GDP" countries. These findings may alert healthcare professionals and designers of health policy towards improving the clinical status of patients with RA in all countries.

Psychometric properties of the French translation of the reduced KOOS and HOOS (KOOS-PS and HOOS-PS).

OBJECTIVE: To evaluate the psychometric properties of the French KOOS physical function (KOOS-PS) and HOOS physical function (HOOS-PS), specifically its feasibility, reliability, construct validity, and responsiveness. METHODS: Consecutive outpatients consulting for primary knee or hip osteoarthritis (OA) in a rheumatology department were included. During the initial assessment, patients were asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaire and the OsteoArthritis Knee and Hip Quality Of Life questionnaire (OAKHQOL). The patients were given a second KOOS or HOOS questionnaire to complete and return by mail 2 weeks later. Feasibility was assessed by calculating the percentage of missing items and the floor and ceiling effects. Test-retest reliability was evaluated using the intra-class correlation coefficient (ICC). Convergent and divergent construct validity was determined by comparing the results of the KOOS-PS or HOOS-PS and OAKHQOL questionnaires using Spearman's rank test. Responsiveness was evaluated using data obtained in other hip or knee OA patients prior to and 1 month after intra-articular hyaluronic acid injection, using standardized response mean (SRM) and effect-size (ES). RESULTS: Eighty-seven patients with knee OA and 50 hip OA patients were included. The KOOS-PS and HOOS-PS scores were obtained for all patients as there were no missing items. Neither a floor nor a ceiling effect was observed. The ICC of KOOS-PS and HOOS-PS was 0.861 (0.763-0.921) and 0.859 (0.725-0.929), respectively. A strong or moderate correlation was observed, as expected, between KOOS-PS, HOOS-PS, and the OAKHQOL physical activities, pain, and mental health domains. A weak correlation was observed, as expected, between KOOS-PS, HOOS-PS, and the other OAKHQOL domains, except for a moderate correlation between the KOOS-PS and social functioning. The responsiveness was demonstrated with SRM and ES of 0.80 and 0.51 (KOOS-PS), 1.10 and 0.62 (HOOS-PS), respectively. CONCLUSION: The French versions of KOOS-PS and HOOS-PS are reliable, valid, and responsive questionnaires for capturing functional disability in people with knee and hip OA.

Comparative, validity and responsiveness of the HOOS-PS and KOOS-PS to the WOMAC physical function subscale in total joint replacement for osteoarthritis.

OBJECTIVE: To evaluate the internal consistency of the Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS) and the Knee injury and Osteoarthritis Outcome Score-Physical Function Short-form (KOOS-PS) in total hip replacement (THR) and total knee (TKR) replacement. Construct validity and responsiveness were compared to the Western Ontario McMaster Universities' Osteoarthritis Index (WOMAC) Likert 3.0 physical function (PF) subscale and the PF excluding the items in the short measures (PF-exclusions). METHODS: Participants completed the full HOOS or KOOS, measures of fatigue, anxiety, depression and the Chronic Pain Grade (CPG) pre-surgery and the HOOS or KOOS 6 months post-surgery. Internal consistency for the HOOS-PS and KOOS-PS was calculated using Cronbach's alpha. For construct validity, it was hypothesized that correlations between the HOOS-PS or KOOS-PS and PF and PF-exclusions with fatigue, CPG, anxiety and depression and HOOS/KOOS pain scales would differ by magnitudes of <0.1. Standardized response means (SRMs) were calculated for the HOOS-PS, KOOS-PS, PF and PF-exclusions and hypothesized to be >1. RESULTS: The THR group (n=201) had a mean age of 62.3 years; 53.2% were female. The TKR group (n=248) had a mean age of 64.5 years; 63.7% were female. Cronbach's alpha was 0.79 and 0.89 for the HOOS-PS and KOOS-PS, respectively, confirming that the measures represented a homogeneous construct. The correlation of the HOOS-PS to the PF and PF-exclusions was 0.90 and 0.86, respectively; r=0.90 (PF) and r=0.85 (PF-exclusions) for the KOOS-PS. The results supported the construct validity hypotheses. For THR, the SRM was 1.5, 1.7 and 1.7 for the HOOS-PS, PF and PF-exclusions; for TKR, the SRM was 1.4, 1.5 and 1.7, respectively. CONCLUSIONS: The short HOOS-PS and KOOS-PS represent homogenous short measures of PF with similar construct validity and responsiveness to the 17-item PF. The HOOS-PS and KOOS-PS are parsimonious, valid and responsive for evaluating PF in THR and TKR.

Multi-language translation and cross-cultural adaptation of the OARSI/OMERACT measure of intermittent and constant osteoarthritis pain (ICOAP).

AIM: To conduct a multi-language translation and cross-cultural adaptation of the Intermittent and Constant OsteoArthritis Pain (ICOAP) questionnaire for hip and knee osteoarthritis (OA). METHODS: The questionnaires were translated and cross-culturally adapted in parallel, using a common protocol, into the following languages: Czech, Dutch, French (France), German, Italian, Norwegian, Spanish (Castillan), North and Central American Spanish, Swedish. The process was conducted following five steps: (1)--independent translation into the target language by two or three persons; (2)--consensus meeting to obtain a single preliminary translated version; (3)--backward translation by an independent bilingual native English speaker, blinded to the English original version; (4)--final version produced by a multidisciplinary consensus committee; (5)--pre-testing of the final version with 10-20 target-language-native hip and knee OA patients. RESULTS: The process could be followed and completed in all countries. Only slight differences were identified in the structure of the sentences between the original and the translated versions. A large majority of the patients felt that the questionnaire was easy to understand and complete. Only a few minor criticisms were expressed. Moreover, a majority of patients found the concepts of constant pain and pain that comes and goes to be of a great pertinence and were very happy with the distinction. CONCLUSION: The ICOAP questionnaire is now available for multi-center international studies.

Comparative evaluation of three semi-quantitative radiographic grading techniques for hip osteoarthritis in terms of validity and reproducibility in 1404 radiographs: report of the OARSI-OMERACT Task Force.

OBJECTIVE: The objective of this work was to compare the measurement properties of three categorical X-ray scoring methods for hip osteoarthritis (OA). METHODS: In data obtained from trials and cohorts, radiographs were evaluated using the Kellgren and Lawrence (KL) grading system, the Osteoarthritis Research Society International (OARSI) joint space narrowing score, and quantitative measurement of joint space width (JSW), analysed as a categorical variable according to Croft and Lane's cutoffs (1.5, 2.5 and 3mm). Predictive validity was assessed through logistic regression to predict joint replacement in one database. Construct validity was assessed through logistic regression between pain and function and X-ray stages. Inter-observer and intra-observer reliability were assessed in 50 subjects by weighted kappa. Sensitivity to change was assessed in 50 patients over a 24-month interval, by standardized response mean (SRM). RESULTS: Radiographs were available from one trial and two cohorts (1404 X-rays). All three methods predicted joint replacement in the trial. Correlation with clinical parameters was low for the three scoring methods, except for the single community-based cohort. Interrater reliability was higher for categorical JSW (kappa, 0.71 vs 0.44 and 0.47 for KL and OARSI, respectively). Intrarater reliability was similar for the three methods (0.79 vs 0.69 and 0.81). Sensitivity to change was higher for categorical JSW than KL and OARSI (SRM, 0.77 vs 0.28 and 0.35). CONCLUSION: Categorical JSW has similar validity and higher sensitivity to change than the other categorical scoring techniques in hip OA. These results indicate categorical JSW may be the preferred method to evaluate structural severity in hip OA clinical trials.

OARSI-OMERACT definition of relevant radiological progression in hip/knee osteoarthritis.

BACKGROUND: Joint space width (JSW) evaluated in millimeters on plain X-rays is the currently optimal recognized technique to evaluate osteoarthritis (OA) structural progression. Data obtained can be presented at the group level (e.g., mean+/-standard deviation of the changes). Such presentation makes difficult the interpretation of the clinical relevance of the reported results. Therefore, a presentation at the individual level (e.g., % progressors) seems more attractive but requires to determining a cut-off. Several methodologies have been proposed to define cut-offs in JSW: arbitrary chosen cut-off, cut-off based on the validity to predict a relevant end-point such as the requirement of total articular replacement or cut-off based on the measurement error such as smallest detectable difference (SDD). OBJECTIVES: The objective of this OARSI-OMERACT initiative was to define a cut-off evaluated in millimeters on plain X-rays above which a change in JSW could be considered as relevant in patients with hip and knee OA. METHODS: The first step consisted in a systematic literature research performed using Medline database up to July 2007 to obtain all manuscripts published between 1990 and 2007 reporting a cut-off value in JSW evaluated in millimeters at either the knee or hip level. The second step consisted in a consensus based on the best knowledge of the 11 experts with the support of the available evidence. RESULTS: Among the 506 articles selected by the search, 47 articles reported cut-off of JSW in millimeters. There was a broad heterogeneity in cut-off values, whatever the methodologies or the OA localization considered (e.g., from 0.12 to 0.84 mm and from 0.22 to 0.78 mm for Knee (seven studies) and hip (seven studies), respectively when considering the data obtained based on the reliability). Based on the data extracted in the literature, the expert committee proposed a definition of relevant change in JSW based on plain X-rays, on an absolute change of JSW in millimeters and on the measurement error e.g., calculation of the SDD using the Bland and Altman technique. The results of the analysis of JSW should be expressed in terms of a dichotomous variable (e.g., progressors yes/no): a patient with a change in JSW during the study over such SDD will fulfill the definition of "progressor". Moreover, the pilot study aimed at evaluating the measurement error should be designed to reflect the different characteristics of the primary study in which the analysis of the radiological findings will be based on (patient's characteristics, centers characteristics, readers). CONCLUSION: This initiative based on both an Evidence Based Medicine (Systematic Literature Research) and Expert Opinion approach resulted in a proposal of definition of relevant radiological progression in OA to be used as end-point in clinical trials and also recommendations on the conduct of the reliability study allowing such definition.

Inflammatory demyelinating events following treatment with anti-tumor necrosis factor.

BACKGROUND: Tumor necrosis factor alpha (TNF-alpha) is an inflammatory cytokine involved in certain inflammatory diseases including multiple sclerosis (MS), rheumatoid arthritis (RA), and Crohn's disease. The anti-TNF-alpha treatments used for RA may be associated with inflammatory demyelinating events affecting the central nervous system and may possibly aggravate known MS. OBJECTIVE: We report here three new cases of inflammatory demyelinating events of the central nervous system following treatment with anti-TNF-alpha. RESULTS: The neurological symptoms appeared on average 5 months after initiation of the treatment. For all patients, the inflammatory process was confirmed by brain magnetic resonance imaging. The symptoms totally or partially regressed as soon as anti-TNF-alpha treatment was stopped except for one patient who developed clinically defined MS. CONCLUSIONS: Inflammatory demyelination of the central nervous system may be associated with the use of anti-TNF-alpha. Patients with rheumatoid arthritis treated with these treatments should benefit from a follow-up which includes brain MRI.