Towards standardized patient reported physical function outcome reporting: linking ten commonly used questionnaires to a common metric.

OBJECTIVES: Outcomes obtained using different physical function patient reported outcome measures (PROMs) are difficult to compare. To facilitate standardization of physical function outcome measurement and reporting we developed an item response theory (IRT) based standardized physical function score metric for ten commonly used physical function PROMs. METHODS: Data of a total of 16,386 respondents from representative cohorts of patients with rheumatic diseases as well as the Dutch general population were used to map the items of ten commonly used physical function PROMs on a continuous latent physical function variable. The resulting IRT based common metric was cross-validated in an independent dataset of 243 patients with gout, osteoarthritis or polymyalgia in which four of the linked PROMs were administered. RESULTS: Our analyses supported that all 97 items of the ten included PROMs relate to a single underlying physical function variable and that responses to each item could be described by the generalized partial credit IRT model. In the cross-validation analyses we found congruent mean scores for four different PROMs when the IRT based scoring procedures were used. CONCLUSIONS: We showed that the standardized physical function score metric developed in this study can be used to facilitate standardized reporting of physical function outcomes for ten commonly used make physical function PROMs.

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.

European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update.

BACKGROUND: Since the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations. METHODS: A systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated. RESULTS: The updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. CONCLUSIONS: These recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

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.

Promoting patient-centred care in psoriatic arthritis: a multidisciplinary European perspective on improving the patient experience.

Patients with psoriatic arthritis (PsA) may not be optimally treated. The impact of the disease extends beyond skin and joint symptoms, impairing quality of life. This indicates that the adoption of a patient-focused approach to PsA management is necessary. An expert multidisciplinary working group was convened, with the objective of developing an informed perspective on current best practice and needs for the future management of PsA. Topics of discussion included the barriers to current best practice and calls to action for the improvement of three areas in PsA management: early and accurate diagnosis of PsA, management of disease progression and management of the impact of the condition on the patient. The working group agreed that, to make best use of the available of diagnostic tools, clinical care recommendations and effective treatments, there is a clear need for healthcare professionals from different disciplines to collaborate in the management of PsA. By facilitating appropriate and rapid referral, providing high quality information about PsA and its treatment to patients, and actively involving patients when choosing management plans and setting treatment goals, management of PsA can be improved. The perspective of the working group is presented here, with recommendations for the adoption of a multidisciplinary, patient-focused approach to the management of PsA.

The EULAR Outcome Measures Library: development and an example from a systematic review for systemic lupus erythematous instruments.

OBJECTIVES: Patient reported outcomes (PROs) are relevant in rheumatology. Variable accessibility and validity of commonly used PROs are obstacles to homogeneity in evidence synthesis. The objective of this project was to provide a comprehensive library of "validated PROs". METHODS: A launch meeting with rheumatologists, PROs methodological experts, and patients, was held to define the library's aims and scope, and basic requirements. To feed the library we performed systematic reviews on selected diseases and domains. Relevant information on PROs was collected using standardised data collection forms based on the COSMIN checklist. RESULTS: The EULAR Outcomes Measures Library (OML), whose aims are to provide and to advise on PROs on a user-friendly manner albeit based on scientific grounds, has been launched and made accessible to all. PROs currently included cover any domain and, are generic or specifically target to the following diseases: rheumatoid arthritis, osteoarthritis, spondyloarthritis, low back pain, systemic lupus erythematosus, gout, osteoporosis, juvenile idiopathic arthritis, and fibromyalgia. Up to 236 instruments (106 generic and 130 specific) have been identified, evaluated, and included. The systematic review for SLE, which yielded 10 specific instruments, is presented here as an example. The OML website includes, for each PRO, information on the construct being measured and the extent of validation, recommendations for use, and available versions; it also contains a glossary on common validation terms. CONCLUSIONS: The OML is an in progress library led by rheumatologists, related professionals and patients, that will help to better understand and apply PROs in rheumatic and musculoskeletal diseases.

European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies.

BACKGROUND: Psoriatic arthritis (PsA) is a clinically heterogeneous disease. Clear consensual treatment guidance focused on the musculoskeletal manifestations of PsA would be advantageous. The authors present European League Against Rheumatism (EULAR) recommendations for the treatment of PsA with systemic or local (non-topical) symptomatic and disease-modifying antirheumatic drugs (DMARD). METHODS: The recommendations are based on evidence from systematic literature reviews performed for non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, synthetic DMARD and biological DMARD. This evidence was discussed, summarised and recommendations were formulated by a task force comprising 35 representatives, and providing levels of evidence, strength of recommendations and levels of agreement. RESULTS: Ten recommendations were developed for treatment from NSAID through synthetic DMARD to biological agents, accounting for articular and extra-articular manifestations of PsA. Five overarching principles and a research agenda were defined. CONCLUSION: These recommendations are intended to provide rheumatologists, patients and other stakeholders with a consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes, based on combining evidence and expert opinion. The research agenda informs directions within EULAR and other communities interested in PsA.

OARSI-OMERACT initiative: defining thresholds for symptomatic severity and structural changes in disease modifying osteoarthritis drug (DMOAD) clinical trials.

OBJECTIVE: Total joint replacement has been proposed as an endpoint in disease modifying osteoarthritis drug (DMOAD) randomized clinical trials (RCTs); however, disparities have generated concerns regarding this outcome. A combined Osteoarthritis Research Society International (OARSI)/Outcome Measures in Rheumatology (OMERACT) initiative was launched in 2004 to develop a composite index ['virtual total joint replacement' (VJR)] as a surrogate outcome for osteoarthritis (OA) progression in DMOAD RCTs. Our objective was to evaluate the prevalence of patients fulfilling different thresholds of sustained pain, reduced function, and X-ray change in existing DMOAD RCTs. DESIGN: Post hoc analysis of summary data from the placebo arm of eight DMOAD RCTs. RESULTS: Eight OA RCTs representing 1379 patients were included. Pain was assessed by WOMAC and/or VAS and function by WOMAC and/or Lequesne. Among six knee and two hip studies, 248 (22%) and 132 (51%) patients respectively had X-ray progression [decrease joint space width (JSW) ≥0.5 mm]. The prevalence of patients fulfilling clinical and radiographic criteria was highest (n = 163, 12%) in the least stringent scenario (pain + function ≥80 at ≥2 visits); with few patients (n = 129, 2%) in the most stringent scenario (pain + function ≥80 at ≥4 visits). Using these prevalence data, a sample size of 352-2144 per group would be needed to demonstrate a 50% difference between groups. CONCLUSIONS: The prevalence of patients with sustained symptomatic OA of at least a moderate degree with X-ray progression is low. Even using lenient criteria to define VJR, large patient numbers would be required to detect differences between groups in DMOAD RCTs. Investigation of the optimal cutoff threshold and combination of symptoms and radiographic change should be pursued.

Disease activity score-driven therapy versus routine care in patients with recent-onset active rheumatoid arthritis: data from the GUEPARD trial and ESPOIR cohort.

OBJECTIVES: To compare the efficacy of disease activity score in 28 joints (DAS28ESR)-driven therapy with anti-tumour necrosis factor (patients from the GUEPARD trial) and routine care in patients with recent-onset rheumatoid arthritis (patients of the ESPOIR cohort). RESULTS: After matching GUEPARD and ESPOIR patients on the basis of a propensity score and a 1:2 ratio, at baseline all patients had comparable demographic characteristics, rheumatoid factor, anticyclic citrullinated peptide antibody positivity and clinical disease activity parameters: erythrocyte sedimentation rate, C-reactive protein, mean DAS (6.26±0.87), Sharp/van der Heijde radiographic score (SHS), health assessment questionnaire (HAQ). Disease duration was longer in GUEPARD patients (5.6±4.6 vs 3.5±2.0 months, p<0.001). After 1 year, the percentage of patients in remission with an HAQ (<0.5) and an absence of radiological progression was higher in the tight control group (32.3% vs 10.2%, p=0.011) as well as the percentage of patients in low DAS with an HAQ (<0.5) and an absence of radiological progression (36.1% vs 18.9%, p=0.045). However, there was no difference in the decrease in DAS, nor in the percentage of EULAR (good and moderate), ACR20, ACR50 and ACR70 responses. More patients in the tight control group had an HAQ below 0.5 (70.2% vs 45.2%, p=0.005). Overall, pain, patient and physician assessment and fatigue decreased more in the tight control group. The mean SHS progression was similar in the two groups as was the percentage of patients without progression. CONCLUSIONS: In patients with recent onset active rheumatoid arthritis, a tight control of disease activity allows more patients to achieve remission without disability and radiographic progression.

Treating rheumatoid arthritis to target: the patient version of the international recommendations.

To transcribe the treat-to-target (T2T) recommendations into a version that can be easily understood by patients. A core group of physicians and patients involved in the elaboration of the T2T recommendations produced a draft version of the T2T recommendations in lay language. This version was discussed, changed and reworded during a 1-day meeting with nine patients with rheumatoid arthritis (RA) from nine different European countries. Finally, the level of agreement with the translation and with the content of the recommendations was assessed by the patient participants. The project resulted in a patient version of the T2T recommendations. The level of agreement with the translation and the content was high. The group discussion revealed a number of potential barriers for the implementation of the recommendations in clinical practice, such as inequalities in arthritis healthcare provision across Europe. An accurate version of the T2T recommendations that can be easily understood by patients is available and can improve the shared decision process in the management of RA.

European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects.

OBJECTIVE: To develop recommendations to enable successful inclusion of the patient perspective in European League Against Rheumatism (EULAR)-funded scientific research projects. METHODS: The EULAR standardised operational procedures for guideline development were followed. A systematic literature review was presented during a first task force meeting, including 3 rheumatologists, 1 rheumatologist/epidemiologist, 2 allied health professionals, 2 representatives of arthritis research organisations and 7 patient representatives, resulting in 38 statements. A Delphi method was carried out to reduce and refine the statements and agree on a set of eight. Next, a survey among a wider group of experts, professionals and patient representatives (n=42), was completed. Feedback from this wider group was discussed at the second meeting and integrated in the final wording of the recommendations. Subsequently, the level of agreement of the group of experts (n=81) was re-evaluated. RESULTS: The project resulted in a definition of patient research partner and agreement on a set of eight recommendations for their involvement in research projects. These recommendations provide practical guidance for organising patient participation, capturing (1) the role of patient research partners, (2) phase of involvement, (3) the recommended number, (4) recruitment, (5) selection, (6) support, (7) training and (8) acknowledgement. CONCLUSION: Collaboration between patients and professionals in research is relatively new. Trials or effectiveness studies are not yet available. Nevertheless, it is possible to define recommendations for the inclusion of patients in research following a solid expert opinion based consensus process.

Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative.

OBJECTIVE: A patient-derived composite measure of the impact of rheumatoid arthritis (RA), the rheumatoid arthritis impact of disease (RAID) score, takes into account pain, functional capacity, fatigue, physical and emotional wellbeing, quality of sleep and coping. The objectives were to finalise the RAID and examine its psychometric properties. METHODS: An international multicentre cross-sectional and longitudinal study of consecutive RA patients from 12 European countries was conducted to examine the psychometric properties of the different combinations of instruments that might be included within the RAID combinations scale (numeric rating scales (NRS) or various questionnaires). Construct validity was assessed cross-sectionally by Spearman correlation, reliability by intraclass correlation coefficient (ICC) in 50 stable patients, and sensitivity to change by standardised response means (SRM) in 88 patients whose treatment was intensified. RESULTS: 570 patients (79% women, mean ± SD age 56 ± 13 years, disease duration 12.5 ± 10.3 years, disease activity score (DAS28) 4.1 ± 1.6) participated in the validation study. NRS questions performed as well as longer combinations of questionnaires: the final RAID score is composed of seven NRS questions. The final RAID correlated strongly with patient global (R=0.76) and significantly also with other outcomes (DAS28 R=0.69, short form 36 physical -0.59 and mental -0.55, p<0.0001 for all). Reliability was high (ICC 0.90; 95% CI 0.84 to 0.94) and sensitivity to change was good (SRM 0.98 (0.96 to 1.00) compared with DAS28 SRM 1.06 (1.01 to 1.11)). CONCLUSION: The RAID score is a patient-derived composite score assessing the seven most important domains of impact of RA. This score is now validated; sensitivity to change should be further examined in larger studies.

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.

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.

Psychometric properties of the OARSI/OMERACT osteoarthritis pain and functional impairment scales: ICOAP, KOOS-PS and HOOS-PS.

OBJECTIVES: To evaluate the psychometric properties of the OARSI-OMERACT questionnaires in comparison to the existing validated scales. METHODS: Consecutive hip or knee osteoarthritis patients consulting in an orthopedic department were enrolled in the study. Data collected were pain using the Intermittent and Constant Osteoarthritis Pain (ICOAP), a Numeric Rating Scale (NRS), the Western Ontario McMaster Universities' Osteoarthritis Index (WOMAC) pain subscale, the Lequesne pain subscale; functional impairment using the Knee disability and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS), the Hip disability and Osteoarthritis Outcome Score-Physical Function Shortform (HOOS-PS), a NRS, the WOMAC function sub-scale, the Lequesne function subscale. Validity was assessed by calculating the Spearman's correlation coefficient between all the scales. Reliability was assessed in out-patients with stable disease comparing the data collected within 2 weeks using the intra-class correlation coefficient (ICC). Responsiveness was assessed on the data from hospitalised patients prior to and 12 weeks after a total joint replacement (TJR) using the standardised response mean. RESULTS: Three hundred patients (mean age=68 years, females=62%, hip OA=57%) were included. There was a moderate to good correlation between ICOAP, KOOS-PS, HOOS-PS and the WOMAC, NRS and Lequesne scales. Reliability of the ICOAP hip OA HOOS-PS and KOOS-PS was good (ICC range 0.80-0.81) whereas it was moderate for knee ICOAP (ICC=0.65). Responsiveness of the ICOAP, KOOS-PS and HOOS-PS 12 weeks after TJR was comparable to responsiveness of other scales (SRM range: 0.54-1.82). CONCLUSIONS: The psychometric properties of the ICOAP, KOOS-PS and HOOS-PS were comparable to those of the WOMAC, Lequesne and NRS.

Influence of flare design on symptomatic efficacy of non-steroidal anti-inflammatory drugs in osteoarthritis: a meta-analysis of randomized placebo-controlled trials.

INTRODUCTION: Non-steroidal anti-inflammatory drugs' (NSAIDs) symptomatic efficacy in osteoarthritis (OA) is often assessed in trials with a "flare design", i.e., including only patients with an increase in their pain after stopping their usual treatment (NSAIDs or analgesic). OBJECTIVE: To evaluate the influence of the "flare design" on NSAIDs apparent symptomatic efficacy in OA. SEARCH STRATEGY: a systematic literature research was performed in Medline, EMBASE and The Cochrane Register up to March 2009. All randomized controlled trials comparing NSAIDs vs placebo symptomatic efficacy in hip, knee, or digital OA were included. DATA COLLECTION AND ANALYSIS: efficacy was evaluated on pain (visual analog scale), and on function (Western Ontario and McMaster Universities OA index or Lequesne index). The magnitude of the treatment effect was evaluated by calculating Cohen's effect size (ES). Meta-analysis of ES according to flare design yes/no was performed. RESULTS: Among the 343 identified studies, 33 (20,915 patients) were included: 27 (18,667 patients) vs 6 (2248 patients) respectively in the group with vs without "flare design". Populations were comparable in each group. ESs were, for pain, -0.66 (95% confidence interval, -0.71 to -0.61), vs -0.45 (-0.54 to -0.36) in the flare design vs "no flare design" group, and for function, -0.50 (-0.55 to -0.44) vs -0.25 (-0.36 to -0.14) respectively. CONCLUSION: Our study suggests that the flare design used in clinical trials evaluating NSAIDs results in a treatment effect of higher magnitude. These results should be considered when designing a trial and/or interpreting the results of a trial.

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.

The prevalence of osteoporosis, osteopenia, and fractures among adults with cystic fibrosis: a systematic literature review with meta-analysis.

Observational studies have indicated a high but heterogeneous prevalence of low bone mineral density for adult patients with cystic fibrosis. Fracture complications were also described. The objective of this study was to determine the prevalence of osteoporosis, osteopenia, and fractures among adult patients with cystic fibrosis. A systematic literature review was conducted using electronic databases. The keywords used were "cystic fibrosis [MeSH] AND bone density." Original studies were eligible if they reported the prevalence of osteoporosis and/or osteopenia and/or fractures in adult patients with cystic fibrosis. A meta-analysis of pooled proportions was performed. Heterogeneity was tested with the Cochran Q statistic, and in the case of heterogeneity a random effect model was used. Of 117 studies, 12 were selected, i.e., that represented a total of 1055 patients. Mean age ranged from 18.5 to 32 years (median: 28.2 years). Mean body mass index ranged from 19.9 to 22.4 (median: 20.7); 53.8% were men. The pooled prevalence of osteoporosis in adults with cystic fibrosis was 23.5% (95% CI, 16.6-31.0). The pooled prevalence of osteopenia was 38% (95% CI, 28.2-48.3). The pooled prevalences of radiological vertebral fractures and nonvertebral fractures were 14% (95% CI, 7.8-21.7) and 19.7% (95% CI, 6.0-38.8), respectively. In conclusion, this systematic literature review with meta-analysis emphasized the high prevalence of osteopenia and osteoporosis in young adults with cystic fibrosis. The prevalence of fracture was also high.

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.

Smokers and non smokers with rheumatoid arthritis have similar clinical status: data from the multinational QUEST-RA database.

OBJECTIVES: To analyse clinical severity/activity of rheumatoid arthritis (RA) according to smoking status. METHODS: The QUEST-RA multinational database reviews patients for Core Data Set measures including 28 swollen and tender joint count, physician global estimate, erythrocyte sedimentation rate (ESR), HAQ-function, pain, and patient global estimate, as well as DAS28, rheumatoid factor (RF), nodules, erosions and number of DMARDs were recorded. Smoking status was assessed by self-report as 'never smoked', 'currently smoking' and 'former smokers'. Patient groups with different smoking status were compared for demographic and RA measures. RESULTS: Among the 7,307 patients with smoking data available, status as 'never smoked,' 'current smoker' and 'former smoker' were reported by 65%, 15% and 20%. Ever smokers were more likely to be RF-positive (OR 1.32;1.17-1.48, p<0.001). Rheumatoid nodules were more frequent in ever smokers (OR 1.41;1.24-1.59, p<0.001). The percentage of patients with erosive arthritis and extra-articular disease was similar in all smoking categories. Mean DAS28 was 4.4 (SD 1.6) in non-smokers vs. 4.0 (SD 1.6) in those who had ever smoked. However, when adjusted by age, sex, disease duration, and country gross domestic product, only ESR remained significantly different among Core Data Set measures (mean 31.7mm in non-smokers vs. 26.8mm in ever smoked category). CONCLUSIONS: RA patients who had ever smoked were more likely to have RF and nodules, but values for other clinical status measures were similar in all smoking categories (never smoked, current smokers and former smokers).