Évaluation de la reproductibilité et de la validité de construit d’une forme modifiée de l’indice algofonctionnel de Lequesne dans l’arthrose du genou

Objectives. – To assess the test-retest reliability and the construct validity of a modified version of the Lequesne index.Methods. – Patients with symptomatic knee osteo-arthritis fulfilling the revised criteria of the american college of rheumatology completed the Lequesne index twice at a 3 h interval. Impairment outcome measures and patients’ perceived discomfort in walking and handicap were recorded. An item by item analysis was performed. Items having insufficient psychometric properties were excluded. Test-retest reliability was assessed using the intraclass correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated using Spearman rank correlation coefficient and a factor analysis was performed.Results. – Eighty-eight patients were included. One question assessing pain (question IE) had a weak reliability (Kappa = 0.39) and was excluded. The test-retest reliability of the modified questionnaire was excellent (ICC = 0.95). Expected convergent and divergent correlations were achieved excepted for Vas pain and Vas handicap (0.46 and 0.40 respectively), and the “a priori” double stratification was confirmed by factor analysis, explaining 48.7% of the variance.Conclusion. – The modified form of the Lequesne index has sufficient psychometric properties to be used to assess pain and function in knee osteo-arthritis in a french population.     

Évaluation de la reproductibilité et de la validité de construit d’une forme modifiée de l’indice algofonctionnel de Lequesne dans l’arthrose du genouAssessment of the test-retest reliability and construct validity of a modified Lequesne index in knee osteo-arthritis

Objectives. – To assess the test-retest reliability and the construct validity of a modified version of the Lequesne index.Methods. – Patients with symptomatic knee osteo-arthritis fulfilling the revised criteria of the american college of rheumatology completed the Lequesne index twice at a 3 h interval. Impairment outcome measures and patients’ perceived discomfort in walking and handicap were recorded. An item by item analysis was performed. Items having insufficient psychometric properties were excluded. Test-retest reliability was assessed using the intraclass correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated using Spearman rank correlation coefficient and a factor analysis was performed.Results. – Eighty-eight patients were included. One question assessing pain (question IE) had a weak reliability (Kappa = 0.39) and was excluded. The test-retest reliability of the modified questionnaire was excellent (ICC = 0.95). Expected convergent and divergent correlations were achieved excepted for Vas pain and Vas handicap (0.46 and 0.40 respectively), and the “a priori” double stratification was confirmed by factor analysis, explaining 48.7% of the variance.Conclusion. – The modified form of the Lequesne index has sufficient psychometric properties to be used to assess pain and function in knee osteo-arthritis in a french population.     

Algo-functional assessment of knee osteoarthritis: comparison of the test-retest reliability and construct validity of the WOMAC and Lequesne indexes

OBJECTIVE: To assess and compare the test-retest reliability and the construct validity of the Lequesne and the French-Canadian version of the WOMAC indexes. DESIGN: Patients with symptomatic knee osteoarthritis (OA) fulfilling the revised criteria of the American College of Rheumatology completed both the Lequesne and the French-Canadian version of the WOMAC indexes twice at a 3-h interval. Impairment outcome measures, patients' perceived discomfort in walking and handicap were recorded. For both questionnaires, an analysis was performed item by item. Repeatability was assessed using the intraclass correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated using the Spearman rank correlation coefficient and a factor analysis was performed. RESULTS: 88 patients were included. Eight questions of the WOMAC section C and one question of the Lequesne index had insufficient psychometric properties. Although repeatability of questionnaires was fair to excellent (0.82, 0.68, 0.74, 0.95 for the WOMAC sections A, B, C and Lequesne index respectively), construct validity could not be demonstrated. Factor analysis of the WOMAC extracted five factors which differed from the a priori triple stratification. Factor analysis of the WOMAC section C extracted two factors explaining 71% of the variance which could not be clinically characterized. For the Lequesne index, expected convergent correlations were not always achieved. Three factors were extracted by factor analysis explaining 58% of the variance. CONCLUSION: Despite their good test-retest reliability, the two composite indexes evaluated are not valid to assess the concept of functional disability induced by knee OA in a French population.     

Assessment of the test-retest reliability and construct validity of a modified WOMAC index in knee osteoarthritis

OBJECTIVE: To assess the test-retest reliability and the construct validity of a modified version of the French-Canadian version of the WOMAC index. METHODS: Open prospective study conducted in departments of Rheumatology, Rehabilitation and Orthopedic surgery of a tertiary care teaching hospital. Eighty-eight patients with symptomatic knee osteoarthritis (OA) fulfilling the revised criteria of the American College of Rheumatology were included. The French-Canadian version of the WOMAC index was completed twice at a 3-h interval. Impairment outcome measures, patients' perceived discomfort in walking and handicap were recorded. An item-by-item analysis was performed. Test-retest reliability was assessed using the intra-class correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated using the Spearman rank correlation coefficient and a factor analysis was performed. RESULTS: Eight questions assessing function (section C) and the two questions assessing stiffness (section B) had insufficient psychometric properties and were excluded. Although test-retest reliability of the questionnaire was fair to good (0.82, 0.85, for the WOMAC section A, and modified section C, respectively), construct validity could not be demonstrated. Factor analysis of the modified form of the WOMAC extracted four factors, which differed from the a priori stratification. However, factor analysis of the modified section C extracted two factors explaining 68.4% of the variance, which could be clinically characterized. CONCLUSION: Despite its good test-retest reliability, the modified WOMAC index is not valid for assessing pain and disability induced by knee OA in a French population. Section A and modified section C could be used separately to assess, respectively, pain and function.     

Translation, adaptation and validation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for an Arab population: the Sfax modified WOMAC

OBJECTIVE: To translate into Arabic and validate the Western Ontario and McMaster Universities (WOMAC) index. METHOD: Arabic translation was obtained with use of the forward and backward translation method. Adaptations were made after a pilot study. Patients with symptomatic knee OA fulfilling the revised criteria of the American College of Rheumatology were included. Impairment outcome measures (pain as measured on a visual analog scale, the maximum distance walked, Kellgren's radiological score), Lequesne index score and Beck depression scale score were recorded. Each item was analyzed. Test-retest reliability was assessed with use of the intra-class correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated with use of Spearman's rank correlation coefficient, and a factor analysis was performed. RESULTS: One hundred and three patients were included in the study. Eight questions of the WOMAC physical function subscale (PF) had insufficient psychometric properties and were excluded. Although test-retest reliability of the questionnaire was good (0.84, 0.84, and 0.92 for pain, stiffness, and modified PF subscales respectively), construct validity could not be demonstrated. Factor analysis of the modified form of the WOMAC extracted four factors, which differed from the a priori triple stratification. However, factor analysis of the modified PF subscales extracted two factors, which accounted for 68.4% of the total variance and could be clinically characterized (disability during activities requiring knee flexion within the first 90 degrees and activities requiring knee flexion over more than 90 degrees ). CONCLUSION: We translated and adapted the WOMAC index into Arabic to suit Tunisian people. The translated questionnaire is reliable but not valid in its original form. We propose the use of a modified version of PF subscale of the WOMAC, although the psychometric properties of this instrument must be examined in a larger population.     

Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Lequesne Algofunctional Index of knee in Asians with knee osteoarthritis in Singapore

OBJECTIVE: To cross-culturally adapt and validate Singapore English and Chinese versions of the Lequesne Algofunctional Index of knee in patients with knee osteoarthritis (OA) in Singapore. METHODS: Singapore English and Chinese versions were cross-culturally adapted from the source English version following standard guideline (including cognitive debriefing). Patients were asked to complete an identical, pretested questionnaire containing the Lequesne index, Short Form 36 Health Survey (SF-36), and EQ-5D twice within 6 days. Reliability was assessed using Cronbach's alpha and intraclass correlation coefficients (ICC). Dimensionality was assessed by principal component factor analysis. Construct validity was tested by item-to-scale correlations and 12 and six a priori hypotheses for convergent and divergent construct validities, respectively. RESULTS: Singapore English and Chinese Lequesne indices were well accepted by patients in pilot testing and were therefore administered to a consecutive sample of 127 English- and 131 Chinese-speaking Singaporeans with knee OA. Acceptable internal consistency was observed for activities of daily living and the global index (alpha=0.72-0.82), and the good test-retest reliability for all scales in both versions (ICC=0.66-0.94). Expected item-to-scale correlations were presented only in activities of daily living in both versions. Factor analysis yielded two factors for both versions. Convergent and divergent construct validities were supported by the presence of hypothesized correlations between the Lequesne index and SF-36 and EQ-5D scales. CONCLUSION: Both versions of the Lequesne index demonstrated acceptable reliability and validity among multiethnic Asian patients with knee OA, which suggests that it could be used as a global index in the health-related quality of life (HRQoL) measurements in Singapore and possibly other Asian countries.     

Reliability, validity, and sensitivity to change of the Cochin hand functional disability scale in hand osteoarthritis

OBJECTIVE: To assess the reliability, validity and sensitivity to change of the Cochin hand functional scale in hand osteoarthritis (OA). BACKGROUND: The Cochin hand functional disability scale has been validated in rheumatoid arthritis. DESIGN: Patients with hand OA according to Altman's criteria were included. Impairment outcome measures (VAS of pain, hand score of tenderness, clinical hand score of impairment, Kallman's radiographic scale), functional disability measures [Cochin scale, Revel's functional index (RFI), Dreiser's functional index (DFI)] and patients' perceived handicap (VAS) were recorded twice, at baseline and at a 6-month follow-up visit. Interobserver reliability was assessed using the intraclass correlation coefficient (ICC) and the Bland and Altman method. Construct (convergent and divergent) validity was investigated using the Spearman rank correlation coefficient and a factor analysis was performed. Sensitivity to change was assessed using the effect size (ES) and the standardized response mean (SRM), and the non-parametric Spearman rank correlation coefficient (r) was used to assess the correlation between quantitative variable changes and patient's overall opinion. RESULTS: 89 patients (8 males, mean age 63 years) were included. Interobserver reliability was excellent (ICC=0.96). The Bland and Altman method showed no systematic trend. Correlations of the Cochin scale score with RFI (r=0.86), DFI (r=0.87), VAS of handicap (r=0.67), VAS of pain (r=0.54), tenderness (r=0.51), clinical impairment (r=0.32), and Kallman's radiographic scale (r=0.13) indicated a good construct validity. Factor analysis extracted four main factors, accounting for 65% of the total variance. 51 patients were evaluated at the 6-month visit. The Cochin scale score had worsened with SRM and ES values of -0.26 and -0.17 respectively. Changes in the score had one of the highest correlation (r=0.47) with the patient's overall opinion. CONCLUSION: The Cochin hand functional disability scale which was first developed to assess the rheumatoid hand can be used to evaluate functional disability in hand OA.     

Évaluation de la reproductibilité et de la validité de construit d’une forme modifiée de l’indice Womac dans l’arthrose du genou

Objective. – To assess the test–retest reliability and the construct validity of a modified version of the French-Canadian version of the Womac index.Methods. – Open prospective study conducted in departments of rheumatology, rehabilitation and orthopedic surgery of a tertiary care teaching hospital. Eighty-eight patients with symptomatic knee osteoarthritis (O.A.) fulfilling the revised criteria of the American College of Rheumatology were included. The French-Canadian version of the Womac index was completed twice at a 3–hour interval. Impairment outcome measures, patients’ perceived discomfort in walking and handicap were recorded. An item by item analysis was performed. Test–retest reliability was assessed using the intraclass correlation coefficient (ICC) and the Bland and Altman method. Construct validity was investigated using the Spearman rank correlation coefficient and a factor analysis was performed.Results. – Eight questions assessing function (section C) and the 2 questions assessing stiffness (section B) had insufficient psychometric properties and were excluded. Although test–retest reliability of the questionnaire was fair to good (0.82, 0.85, for the Womac section A, and modified section C respectively), construct validity could not be demonstrated. Factor analysis of the modified form of the Womac extracted 4 factors which differed from the a priori stratification. However, factor analysis of the modified section C extracted 2 factors explaining 68.4% of the variance which could be clinically characterized.Conclusion. – Despite its good test–retest reliability, the modified Womac index is not valid for assessing pain and disability induced by knee OA in a French population. Section A and modified section C could be used separately to assess respectively pain and function.     

Relative efficiency and validity properties of a visual analogue vs a categorical scaled version of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index: Spanish versions

OBJECTIVE: To compare the performance of visual analogue (VAS) vs categorical (CT) scaled versions of the three subscales (pain, stiffness and difficulty) of the WOMAC Index in patients with knee osteoarthritis. MATERIAL AND METHODS: Patients with knee OA (at least grade II of Kellgren & Lawrence classification) were treated for a 6-weeks period with an NSAID. The following measures were applied at baseline and after treatment: VAS and CT WOMAC scales, Lequesne Index, pain on VAS, and global assessment by patient and observer. Construct Validity was determined by correlation of each of the subscale scores with the other outcomes both at baseline and after treatment (Pearson's test); responsiveness comparing baseline vs final status by Wilcoxon's test; reliability by analysis of the internal consistency using Cronbach's alpha at baseline and after the treatment period; and test-retest reliability by Kendall's Tau-c statistics. Finally, correlation and analysis of the relative efficiency (RE) between the subscales of both formats were tested. RESULTS: Seventy-three (8 men and 65 women) patients with a mean disease duration from first diagnosis of 69 months (3 to 254) completed the study. The following were the observed values for the instruments' psychometric properties: (1) construct validity: correlations ranged from 0.30 to 0.84 for VAS and 0.27 to 0.77 for CT subscales; (2) responsiveness: achieved P values for the pain, stiffness and difficulty scales were P<0.0001, P=0.002 and P<0.0001 in VAS and P=0.003, P<0.0001 and P=0.001 in CT format respectively; (3) internal consistency: the obtained Cronbach's alpha coefficients ranged from 0.71 to 0.97 for the VAS and 0.64 to 0.95 for the CT subscales; (4) test-retest reliability: correlation coefficients ranged from 0.36 to 0.76 for VAS and 0.34 to 0.52 for CT subscales; and (5) the relative efficiency of the subscales in VAS vs CT format were 2.20, 0.91 and 1.91 for pain, stiffness and difficulty respectively. Significant correlations between subscales in both formats ranging from 0.72 to 0.86 were observed. CONCLUSION: We have shown that both the VAS version of WOMAC have adequate evaluative and discriminative properties. We found the pain and physical function scales in VAS format and the stiffness scale in CT format to have a slightly better performance in this sample.     

Development and preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative

OBJECTIVE: To evaluate the measurement properties of a new osteoarthritis (OA) pain measure. METHODS: The new tool, comprised of 12 questions on constant vs intermittent pain was administered by phone to 100 subjects aged 40+ years with hip or knee OA, followed by three global hip/knee questions, the Western Ontario and McMaster Universities (WOMAC) pain subscale, the symptom subscales of the Hip Disability and OA Outcome Score (HOOS) or Knee Injury and OA Outcome Score (KOOS), and the limitation dimension of the Late Life Function and Disability Instrument (LLFDI). Test-retest reliability was assessed by re-administration after 48-96h. Item response distributions, inter-item correlations, item-total correlations and Cronbach's alpha were assessed. Principle component analysis was performed and test-retest reliability was assessed by intra-class correlation coefficient (ICC). RESULTS: There was good distribution of response options across all items. The mean intensity was higher for intermittent vs constant pain, indicating subjects could distinguish the two concepts. Inter-item correlations ranged from 0.37 to 0.76 indicating no item redundancy. One item, predictability of pain, was removed from subsequent analyses as correlations with other items and item-total correlations were low. The 11-item scale had a corrected inter-item correlation range of 0.54-0.81 with Cronbach's alpha of 0.93 for the combined sample. Principle components analysis demonstrated factorial complexity. As such, scoring was based on the summing of individual items. Test-retest reliability was excellent (ICC 0.85). The measure was significantly correlated with each of the other measures [Spearman correlations -0.60 (KOOS symptoms) to 0.81 (WOMAC pain scale)], except the LLFDI, where correlations were low. CONCLUSIONS: Preliminary psychometric testing suggests this OA pain measure is reliable and valid.     

Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee

OBJECTIVE: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee and the hip. We adapted the WOMAC for the Italian language and tested its metric properties in 304 patients with symptomatic OA of the knee. METHODS: Three hundred and four consecutive patients, attending 29 rheumatologic outpatient clinic in northern, central, and southern Italy, were asked to answer two disease-specific questionnaires (WOMAC and Lequesne algofunctional index) and one generic instrument (Medical Outcomes Study SF-36 Health Survey-MOS SF-36). A sample of 258 patients was readministered the WOMAC 7-10 days after the first visit and the structured interview, which also assessed demographic and other characteristics. Internal consistency was assessed using Cronbach's alpha, reliability using intraclass correlation coefficients (ICCs), and construct and discriminant validity using Spearman's correlations, Wilcoxon rank sum test, and Kruskal-Wallis test. RESULTS: All WOMAC subscales (pain, stiffness, and physical function) were internally consistent with Cronbach's coefficient alpha of 0.91, 0.81, and 0.84, respectively. Test-retest reliability was satisfactory with ICCs of 0.86, 0.68, and 0.89, respectively. In comparison with the SF-36, the expected correlations were found when comparing items measuring similar constructs, supporting the concepts of convergent construct validity. Very high correlations were also obtained between WOMAC scores and Lequesne OA algofunctional index. WOMAC physical function, but not WOMAC stiffness and pain subscales, was weakly associated with radiological OA severity (P=0.03). Also, WOMAC pain score was inversely correlated (P=0.01) with years of formal education. Examination of discriminant validity showed that the scores on the WOMAC and SF-36 followed hypothesized patterns: the WOMAC discriminated better among subjects with varying severity of knee problems, whereas the SF-36 discriminated better among subjects with varying levels of self-reported health status and comorbidity. CONCLUSION: The Italian version of WOMAC is a reliable and valid instrument for evaluating the severity of OA of the knee, with metric properties in agreement with the original, widely used version.     

Cross-cultural adaptation and validation of Korean Western Ontario and McMaster Universities (WOMAC) and Lequesne Osteoarthritis Indices for Clinical Research

OBJECTIVE: Our aims were to translate WOMAC and Lequesne osteoarthritis (OA) indices into Korean (KWOMAC, KLequesne) and confirm their reliability, validity, and responsiveness. DESIGN: The WOMAC and Lequesne indices were translated into Korean by three translators and translated back into English by three different translators. Fifty consecutive patients with OA were asked to rate the comprehensibility of the questions on a 4-point scale. The comprehensibility (responding with 'good' and 'very good') ranged from 78% to 99%. Test-retest was performed in another 47 patients with knee OA. The final 53 patients with knee OA, within the context of a clinical trial of two non-steroidal antiinflammatory drugs for 4 weeks, were studied to assess the internal consistency, construct validity, and responsiveness of the Korean versions. RESULTS: The test-retest reliability of the KWOMAC 3 subscales and the KLequesne yielded intraclass correlation coefficients of 0.79-0.89 and 0.87. The Cronbach standardized alphas were 0.81-0.96 and 0.75, respectively. For the construct validity, the correlation coefficients of both the KWOMAC subscales and the KLequesne with patient pain assessment and patient global assessment were between 0.30 and 0.70 and the KWOMAC subscales correlated with the KLequesne (0.41-0.55). For responsiveness, the KWOMAC and KLequesne scores significantly improved by 4-week post-treatment compared with pre-treatment; effect size values were between 0.41 and 0.69 for the KWOMAC subscales and 0.70 for the KLequesne; and the relative efficiency values of the KWOMAC subscales vs the KLequesne were between 0.87 and 0.90. CONCLUSIONS: The reliability, validity, and responsiveness of the KWOMAC and the KLequesne are confirmed.     

Cultural adaptation and validation of a German version of the Arthritis Impact Measurement Scales (AIMS2)

OBJECTIVE: To validate a translated and culturally adapted version of the Arthritis Impact Measurement Scale (AIMS) 2 in primary care patients with osteoarthritis (OA) of the hip and knee. METHOD: The AIMS2 was translated into German and culturally adapted. The questionnaire then was administered to 220 primary care patients with OA of the knee or hip. Two hundred and nine questionnaires were returned and analysed. Test-retest reliability was tested in 50 randomly selected patients, of those 42 completed the questionnaire after 2 weeks for a second time. RESULTS: Item-scale correlations were reasonably good as well as the discriminative power of separate scales. The assessment of internal consistency reliability also revealed satisfactory values; Cronbach's alpha was 0.77 or higher for all scales. The test-retest reliability, estimated in an intraclass correlation coefficient (ICC), exceeded 0.90, except the "social activities" scale (0.87). Since only patients with OA of the lower limb were enrolled, substantial floor effects occurred in the "arm function" (28.2%) and the "hand and finger function" scale (29.2%). The principal factor analysis confirmed the postulated three-factor structure with a physical, physiological and social dimension, explaining 48.5%, 13.9% and 6.8% of the variation, respectively. External validity was assessed by calculating correlations to the Western Ontario and MacMaster (WOMAC) osteoarthritis questionnaire a pain visual analogue scale (VAS) and the Kellgren score as well as to disease duration. Spearman's "R" achieved satisfactory values for the corresponding WOMAC scales and the pain-VAS. Correlations with disease duration as well as with the radiological grading were low. CONCLUSION: The GERMAN-AIMS2 is a reliable and valid instrument to assess the quality of life (QoL) in primary care patients suffering from OA.     

Construct validity of the DynaPort KneeTest: a comparison with observations of physical therapists

OBJECTIVE: To assess the construct validity of the DynaPort KneeTest (KneeTest), which is a performance-based test to assess functioning of patients with knee osteoarthritis (OA). Scores on the KneeTest (KneeScore) were compared with observations of physical therapists of the patients' functional disability. The reliability of these observations was also assessed. METHOD: Twelve physical therapists received identical video tapes showing the performance of 33 patients on the KneeTest. Each physical therapist rated the functional disability of each patient, performing the 23 activities of the KneeTest, on 23 Visual Analogue Scales (VAS(activity)). The 23 VAS(activity) scores were averaged into a VAS(average) score. At the end of the test, an overall rating for the general performance of the patient was given on a VAS(overall). Inter-observer Reliability was assessed for the VAS(activity) scores, VAS(average), and the VAS(overall). RESULTS: Inter-observer reliability of the VAS(average) was higher (ICC 0.85, 95% CI 0.74-0.92) than the VAS(overall) (ICC 0.65, 95% CI 0.51-0.77). The correlation between the KneeScore and the VAS(average), averaged over the 12 physiotherapists, was 0.86. CONCLUSION: The construct validity of the KneeTest was supported by the strong correlation with the ratings of the patients' disability by physical therapists. Given these findings and the high test-retest reliability of the KneeTest that was found in our previous study, we conclude that the KneeTest is a valid measure for assessing functioning in orthopedic and physical therapy research in patients with knee-OA before and after total knee replacement. Longitudinal validity has to be evaluated yet.     

Aceclofenac vs paracetamol in the management of symptomatic osteoarthritis of the knee: a double-blind 6-week randomized controlled trial

OBJECTIVE: To evaluate the efficacy and tolerability of aceclofenac, 200 mg/day, and paracetamol, 3000 mg/day, in the treatment of osteoarthritis (OA) of the knee. METHODS: This was a double-blind, parallel-group, multicentre clinical trial involving patients with symptomatic OA of the knee, conducted in Spain. Patients were randomly allocated to aceclofenac 100 mg twice daily (n=82) or paracetamol 1000 mg three times daily (n=86). Patients were assessed at baseline and 6 weeks. Primary efficacy measures were severity of pain (visual analogue scale, VAS), Lequesne OA knee index, and patient's and physician's global assessment of disease activity. Severity of knee pain at rest or walking, stiffness, knee swelling and tenderness, and assessment of health-related quality of life (Health Assessment Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index, and Short Form 36) were included as secondary endpoints. RESULTS: Both treatment groups showed significant improvement compared with their baseline values in the four primary endpoints. Mean between-treatment differences favoured aceclofenac over paracetamol on pain (VAS, 7.64 mm [95% confidence interval (CI), 0.44-14.85 mm]), Lequesne OA index (1.41 [95% CI, 0.45-2.36]), and patient's (0.33 [95% CI, 0.06-0.61]) and physician's (0.23 [95% CI, 0.01-0.47]) global assessments. Adverse events were similar for both drugs (paracetamol, 29% patients vs aceclofenac, 32%; P=0.71). Four patients withdrew in each group due to adverse events. Patients tended to prefer aceclofenac to paracetamol (P=0.001), and more treated with paracetamol withdrew from the study due to lack of efficacy (n=8 vs n=1, P=0.035, for paracetamol and aceclofenac, respectively). CONCLUSION: At 6 weeks, patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with aceclofenac than paracetamol with no difference in tolerability.     

Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index

OBJECTIVE: To evaluate the acceptability, reliability, validity and responsiveness of the Turkish version of Western Ontario and McMaster Universities (WOMAC) osteoarthritis (OA) index in physiotherapy outpatient practice in Turkey. METHOD: Data were obtained from 72 patients with OA of the knee. They were asked to answer two disease-specific questionnaires (WOMAC LK 3.1 and Lequesne-Algofunctional Index of Severity for the knee) and one generic instrument (Medical Outcomes study SF-36 Survey-SF-36). Acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. Reliability was assessed using Cronbach's alpha. Content validity was assessed by examining the floor and ceiling effects, and skew of the distributions. Convergent and divergent validity was assessed by examining the Pearson's correlation coefficients. Responsiveness was determined by examining effect size (ES), standardized response means (SRM) and P values generated using Wilcoxon's test. RESULTS: The overall response rate was 100%. Alpha values for all WOMAC subscales exceeded the value of 0.70 at both baseline and follow-up assessments. Frequency distributions of scores were symmetrical. Subscales had negligible floor and ceiling effects. Both pain and physical function subscales were fairly correlated with the subscales measuring similar constructs of SF-36, whereas they were weakly correlated with other dimensions of SF-36. A good correlation was obtained between WOMAC total and Lequesne index. The pain and physical function subscales of WOMAC index were the most responsive subscales. CONCLUSION: The Turkish WOMAC OA index is acceptable, valid, reliable and responsive for use in Turkish patients with knee OA.     

Cross-cultural adaptation and validation of the Turkish version of the Functional Index for Hand Osteoarthritis (FIHOA)

BackgroundTo perform reliability and validity study of the Functional Index for Hand Osteoarthritis (FIHOA) in the Turkish language.MethodsFIHOA was translated into Turkish following the principles of cross-cultural adaptation. Our translation was firstly tested in 40 patients with hand osteoarthritis. Adapted FIHOA questionnaire was then administrated to 100 hand OA patients successively with Modified Health Assessment Questionnaire (mHAQ), Numerical Rating Scale (NRS), and Short Form-36 (SF-36). Patients filled out the FIHOA questionnaire one more time after five days for test-retest assessment. Patients were divided into two groups as symptomatic or asymptomatic, with a NRS score of 5 or above defining symptomatic OA. Internal consistency was assessed by Cronbach's alpha and intraclass correlation coefficient (ICC) of test-retest reliability. Spearman correlation analysis was used to determine the correlation and validity between data. External construct validity was assessed using the correlation between FIHOA, mHAQ, hand pain NRS, and negative correlation with SF-36 subgroups.ResultsAccording to the total score, Cronbach-alpha was found as 0.90, while ICC was determined as 0.98 for test-retest reliability. When the correlations between the FIHOA questionnaire, mHAQ, and NRS questionnaires were examined, significant correlations were determined, and negative correlations between FIHOA and SF-36 subgroups were observed.ConclusionTurkish FIHOA is a reliable and valid method for assessing functionality in Turkish patients with hand osteoarthritis.     

Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests

OBJECTIVE: To investigate the effects of intraarticular hyaluronic acid (HA) (Artzal, Seikagaku Corp., Japan) in geriatric participants with unilateral knee osteoarthritis (OA). METHOD: This was a prospective, observer-blind study with 6 months follow-up done in the setting of an outpatient rehabilitation department in a university-affiliated tertiary care medical center. Sixty-eight patients, aged 65 years or above, with symptoms and radiographic evidence of unilateral knee OA for at least 6 months were recruited. Patients received five weekly intraarticular injections of Artzal into symptomatic knees. Fifty-six participants completed the study. Fifty age-, body mass- and gender-matched healthy individuals were selected as control. Visual analog scale (VAS), Lequesne index and four balance tests including single-leg stance test (SLS), function reach test (FRT), timed "Up-and-Go" test (TUG) and Berg balance scale (BBS) were assessed before injection and at each follow-up visit in the OA group. Four balance tests were obtained on healthy participants for data comparison. RESULTS: Before Artzal injections, the OA group showed significantly worse VAS, Lequesne index and four balance tests scores than did the control group (P < 0.001). Significant improvement in all outcome measures were noted at 1 week, 1, 3 and 6 months post the fifth injection compared with baseline before injection. Local adverse events were reported in four patients (7.1%). CONCLUSION: Significant improvement in pain, physical function and balance tests was demonstrated after five weekly Artzal injections in geriatric patients with knee OA. The effect had rapid onset at 1 week and may last for 6 months.     

Cross-cultural adaptation and validation of the French version of the Knee injury and Osteoarthritis Outcome Score (KOOS) in knee osteoarthritis patients

OBJECTIVE: To adapt the Knee injury and Osteoarthritis Outcome Score (KOOS) into French and to evaluate the psychometric properties of this new version. METHODS: The French version of the KOOS was developed according to cross-cultural guidelines by using the "translation-back translation" method to ensure content validity. KOOS data were then obtained in patients with symptomatic knee osteoarthritis (OA). The translated questionnaire was evaluated in two knee OA population groups, one with no indication for joint replacement (medicine), and the other waiting for joint replacement (surgery). The psychometric properties evaluated were feasibility: percentage of responses, floor and ceiling effects; construct validity: internal consistency using Cronbach's alpha, correlations with osteoarthritis knee and hip quality of life domains using Spearman's rank test, and known group comparison between medicine and surgery groups; reliability: intra-class correlation coefficient (ICC), Bland and Altman representation; responsiveness using data obtained prior to and 3 months after surgery: standardized response mean (SRM), and effect size. RESULTS: Thirty-seven patients were included in the medicine group (68% women, mean age=70+/-10 years) and 30 in the surgery group (73% women, mean age=71+/-10 years). The percentage of responses was excellent. Neither a floor nor a ceiling effect was observed, except for the sport and recreation subscale (20.6% of patients with the worst possible score in the medicine group, 40 and 0% in the surgery group prior to and after surgery, respectively). Results for internal consistency (Cronbach's alpha ranging from 0.76 to 0.93), and convergent and divergent construct validity were satisfactory. The patients waiting for knee surgery presented with significantly lower scores in all KOOS domains. The reproducibility of measurements of all KOOS subscales was good to excellent, with ICC ranging from 0.755 to 0.914. The responsiveness was high, with SRM ranging from 0.89 to 1.93, and effect size from 1.31 to 2.8. CONCLUSION: The French version of KOOS is a valid, reliable, and responsive instrument to capture specific aspects of functional disability affecting quality of life of knee OA patients.