Clinimetric properties of WOMAC Index in Greek knee osteoarthritis patients: comparisons with both self-reported and physical performance measures.

This observational study aimed to examine the clinimetric properties of the Greek for Greece translation of the Western Ontario and McMaster Osteoarthritis Index (WOMAC(®)). One hundred and twenty-three patients with knee osteoarthritis (mean age 69.5 years) participated in the study. An extensive reliability study was carried out to assess WOMAC's internal consistency and repeatability (8-day interval). In addition, we examined the construct (convergent, nomological and known-groups) and criterion-related (concurrent and predictive) validity of the index against both self-report [SF-36 and combined visual analog/faces pain scale-revised (VAS/FPS-R)] and physical performance measures [timed up and go test (TUG)]. The internal consistency of the WOMAC subscales ranged from high (0.804) to excellent (0.956). Intra-class correlation coefficients for test-retest reliability were excellent, ranging from 0.91 to 0.95. Partial correlation analysis, adjusted for age and use of an assistive device, showed that WOMAC scores were significantly associated with all validation criteria, presenting fair to strong (-0.33 to -0.86) correlation coefficients. WOMAC-function was strongly associated with SF36-function (-0.86) and TUG (0.71), WOMAC-pain to VAS/FPS-R (0.71) and SF36-pain (-0.67). Of all WOMAC outcomes, stiffness subscale had the lowest, though still significant, correlations with all validation criteria. Multiple linear regression analyses indicated that WOMAC-function was a significant factor for TUG, WOMAC-pain for VAS/FPS-R and both for SF36-function and SF36-pain. The WOMAC LK3.1 Greek for Greece Index is a reliable and valid assessment tool for the evaluation of individuals with knee osteoarthritis, showing excellent reliability and significant validity properties.

A meta-analysis of genome-wide association studies identifies novel variants associated with osteoarthritis of the hip.

OBJECTIVES: Osteoarthritis (OA) is the most common form of arthritis with a clear genetic component. To identify novel loci associated with hip OA we performed a meta-analysis of genome-wide association studies (GWAS) on European subjects. METHODS: We performed a two-stage meta-analysis on more than 78,000 participants. In stage 1, we synthesised data from eight GWAS whereas data from 10 centres were used for 'in silico' or 'de novo' replication. Besides the main analysis, a stratified by sex analysis was performed to detect possible sex-specific signals. Meta-analysis was performed using inverse-variance fixed effects models. A random effects approach was also used. RESULTS: We accumulated 11,277 cases of radiographic and symptomatic hip OA. We prioritised eight single nucleotide polymorphism (SNPs) for follow-up in the discovery stage (4349 OA cases); five from the combined analysis, two male specific and one female specific. One locus, at 20q13, represented by rs6094710 (minor allele frequency (MAF) 4%) near the NCOA3 (nuclear receptor coactivator 3) gene, reached genome-wide significance level with p=7.9×10(-9) and OR=1.28 (95% CI 1.18 to 1.39) in the combined analysis of discovery (p=5.6×10(-8)) and follow-up studies (p=7.3×10(-4)). We showed that this gene is expressed in articular cartilage and its expression was significantly reduced in OA-affected cartilage. Moreover, two loci remained suggestive associated; rs5009270 at 7q31 (MAF 30%, p=9.9×10(-7), OR=1.10) and rs3757837 at 7p13 (MAF 6%, p=2.2×10(-6), OR=1.27 in male specific analysis). CONCLUSIONS: Novel genetic loci for hip OA were found in this meta-analysis of GWAS.

Clinically meaningful effect of strontium ranelate on symptoms in knee osteoarthritis: a responder analysis.

OBJECTIVES: The aim of this study was to assess the efficacy of strontium ranelate in improving symptoms in knee OA. METHODS: Symptoms were assessed over 3 years in patients with primary knee OA receiving strontium ranelate 2 g/day (n = 454), 1 g/day (n = 445) or placebo (n = 472) in the Strontium Ranelate Efficacy in Knee Osteoarthritis Trial. Clinical response was evaluated using WOMAC subscores, minimal perceptible clinical improvement (MPCI), minimal clinically important improvement (MCII) and a modified OMERACT-Osteoarthritis Research Society International (OARSI) responder definition. Patients who withdrew prematurely from the study were considered non-responders. RESULTS: There was no significant effect on symptoms for strontium ranelate 1 g/day. At the dosage of 2 g/day, strontium ranelate was associated with greater response than placebo in terms of ≥20% improvement in WOMAC pain from baseline to the last visit (58% vs 47%, P = 0.002) and ≥50% improvement in WOMAC pain (42% vs 36%, P = 0.083). Significant differences were found in MPCI response for WOMAC pain (52% vs 40%, P < 0.001), stiffness (47% vs 39%, P = 0.009) and physical function (46% vs 37%, P = 0.009) and in MCII response for WOMAC physical function (46% vs 37%, P = 0.013). There were also more OMERACT-OARSI-like responders with strontium ranelate (44% vs 35%, P = 0.004). The treatment-placebo difference in MPCI response for WOMAC pain was significant after 6 months (P = 0.024), while that in MPCI and MCII response for WOMAC physical function reached significance after 12 months (P = 0.027 and P = 0.019, respectively). CONCLUSION: Treatment with strontium ranelate 2 g/day over 3 years is associated with a clinically meaningful improvement in pain from 6 months as well as physical function and stiffness as assessed by the number of responders above thresholds of clinical relevance. TRIAL REGISTRATION: Current Controlled Trials. http://www.controlled-trials.com/ (ISRCTN41323372).

Comparative validation of the WOMAC osteoarthritis and Lequesne algofunctional indices in Greek patients with hip or knee osteoarthritis.

PURPOSE: To comparatively evaluate the reliability and validity of the Western Ontario and McMaster (WOMAC) and the Lequesne algofunctional indices in Greek patients with hip or knee osteoarthritis (OA). METHODS: The Greek versions of WOMAC LK 3.1 and Lequesne indices were administered to 97 outpatients with OA. Internal consistency reliability was assessed by Cronbach's alpha and item-scale correlations. Test-retest reliability was examined with intraclass correlations. Patients were also asked to complete the Short Form 36 (SF-36) and a Visual Analog Scale capturing strength of pain, in order to assess construct validity. Additional demographic and clinical data were also recorded to evaluate further associations. RESULTS: Cronbach's alpha values of the WOMAC ranged between 0.92 and 0.98 for hip and 0.89-0.97 for knee OA. The respective values for Lequesne were 0.63-0.74 and 0.74-0.80. Item-scale correlations confirmed the superiority of WOMAC with respect to internal consistency reliability. Intraclass correlations were 0.79-0.97 and 0.57-0.98 for hip and 0.86-0.97 and 0.82-0.97 for knee OA, for WOMAC and Lequesne, respectively. The two indices showed high correlations with comparable subscales of SF-36 and the Visual Analog Scale. Significant relationships were identified for age, body mass index, duration of disease, duration of stiffness and radiographic classification. CONCLUSIONS: Our findings, in samples of knee and hip OA patients, indicate that the WOMAC index demonstrates better internal consistency reliability than the Lequesne counterpart, as well as equivalent test-retest reliability and construct validity.

Proposed Specifiers for Conduct Disorder (PSCD): Further validation of the parent-report version in a nationally representative U.S. sample of 10- to 17-year-olds.

The Proposed Specifiers for Conduct Disorder (PSCD; Salekin & Hare, 2016) is a new self-report and informant measure designed to assess psychopathic characteristic domains along with symptoms of conduct disorder in youth. Previous factor analytic studies on the PSCD have found that the items are accounted for by a four-factor model reflecting grandiose-manipulative, callous-unemotional, daring-impulsive, and conduct disorder (CD) symptoms. The present study examined the factor structure, psychometric properties, and criterion-related validity of the parent-report version of the PSCD (PSCD-P) in a nationally representative U.S. sample of children and adolescents (N = 1,091, Mage = 13.39, SD = 2.20, range age = 10-17; 50.0% boys, 76% White). Confirmatory factor analyses for the full (24-item) and a shortened (13-item) PSCD-P revealed good internal reliability estimates and support for the four-factor model (grandiose-manipulative, callous-unemotional, daring-impulsive, CD). Results also provided evidence for (a) measurement invariance of the PSCD-P items across sex, race/ethnicity, and age of the child; (b) convergent validity with CD/oppositional defiant disorder symptoms and discriminant validity with a measure of neuroticism; and (c) criterion-related validity with respect to prosociality, peer and family functioning, reactive and proactive aggression, delinquency, academic performance, and substance use. The prevalence for psychopathic personality propensity was found to be 2%. We discuss clinical and research implications regarding the use of the parent-report version of the PSCD for school-aged children. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis. METHODS: Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5-5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372). RESULTS: The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: -0.23 (SD 0.56) mm; 2 g/day: -0.27 (SD 0.63) mm; placebo: -0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated. CONCLUSIONS: Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.

The Proposed Specifiers for Conduct Disorder - Parent (PSCD-P): Convergent Validity, Incremental Validity, and Reactions to Unfamiliar Peer Confederates.

Youth who experience psychopathy display multiple impairments across interpersonal (grandiose-manipulative [GM]), affective (callous-unemotional [CU]), lifestyle (daring-impulsive [DI]), and potentially antisocial and behavioral features. Recently, it has been acknowledged that the inclusion of psychopathic features can offer valuable information in relation to the etiology of Conduct Disorder (CD). Yet, prior work largely focuses on the affective component of psychopathy, namely CU. This focus creates uncertainty in the literature on the incremental value of a multicomponent approach to understanding CD-linked domains. Consequently, researchers developed the Proposed Specifiers for Conduct Disorder (PSCD; Salekin & Hare, 2016) as a multicomponent approach to assess GM, CU, and DI features in combination with CD symptoms. The notion of considering the wider set of psychopathic features for CD specification requires testing whether multiple personality dimensions predict domain-relevant criterion outcomes above-and-beyond a CU-based approach. Thus, we tested the psychometric properties of parents' reports on the PSCD (PSCD-P) in a mixed clinical/community sample of 134 adolescents (Mage = 14.49, 66.4% female). Confirmatory factor analyses resulted in a 19-item PSCD-P displaying acceptable reliability estimates and a bifactor solution consisting of GM, CU, DI, and CD factors. Findings supported the incremental validity of scores taken from the PSCD-P across multiple criterion variables, including (a) an established survey measure of parent-adolescent conflict; and (b) trained independent observers' ratings of adolescents' behavioral reactions to laboratory controlled tasks designed to simulate social interactions with unfamiliar peers. These findings have important implications for future research on the PSCD and links to adolescents' interpersonal functioning.

Cross-cultural adaptation, validation, and responsiveness of the Korean version of the AUSCAN Osteoarthritis Index.

The Australian/Canadian Osteoarthritis Hand Index (AUSCAN) is a patient self-reported 15-item questionnaire measuring the severity of hand osteoarthritis symptoms in the respect of pain, stiffness, and function. In this study, we developed a Korean version of the AUSCAN Index (K-AUSCAN) and confirmed its reliability, validity, and responsiveness. The AUSCAN Index was translated into Korean by 3 translators and translated back into English by 3 different translators. In a group of 53 patients with clinical hand osteoarthritis (mean age 58.3 ± 7.6 years), validity was evaluated against other outcome measures, including the Functional Index for Hand Osteoarthritis (FIHOA) and Multidimensional Health Assessment Questionnaire (MDHAQ). Test-retest reliability was assessed at a 2-weeks interval in 51 patients. Internal consistency of K-AUSCAN was evaluated by Cronbach's α. Responsiveness was measured by standardized response mean (SRM). The test-retest reliability of K-AUSCAN yielded intraclass correlation coefficient of 0.46 for pain, 0.58 for stiffness, and 0.67 for function. The internal consistency of K-AUSCAN was satisfactory with Cronbach's α of 0.89 for pain and 0.93 for function. The K-AUSCAN index showed good correlation with other measures (r (2) was 0.67 for K-AUSCAN pain and MDHAQ pain; r (2) was 0.72 for K-AUSCAN function and FIHOA). The pain and function of K-AUSCAN correlated substantially with each other and moderately with stiffness subscale. The average SRM for K-AUSCAN pain, stiffness, and function was -0.92, -0.48, and -0.84, respectively. The Korean version of the AUSCAN Index is a valid, reliable, and responsive tool for the assessment of hand osteoarthritis symptoms.

Epidemiology of traumatic epidural hematoma in young age.

BACKGROUND: Epidural hematoma (EDH) is a major traumatic brain injury and a potentially life-threatening condition, with the mortality rate in the young age group varying across studies. The aim of this analysis was to investigate the magnitude of traumatic EDH in young patients aged 0 year to 24 years in Queensland, Australia. METHODS: Study patients presented to the emergency department of 14 public hospitals participating in the Queensland Trauma Registry during 2005 to 2007 and were diagnosed and admitted for treatment of EDH. Age group comparisons were performed for demographic, injury, treatment, operation details, and outcome-related variables. RESULTS: We identified 224 young patients with traumatic EDH. The most frequent cause of injury was a fall in the 0 year to 9 years age groups and road traffic crash in those aged 10 years to 24 years. Almost 81% of the EDH cases were due to accidental injury, 17% due to assault, with the remainder due to self-harm and undetermined intent. Skull fracture was present in 75% of the study patients. Neurosurgical operations were performed on 40%. The overall Injury Severity Score adjusted in-hospital mortality rate was 4.8%. The odds of in-hospital mortality was 2.5 (95% confidence interval, 0.8-8.2) compared with older patients (25-64 years). CONCLUSIONS: The results indicate that the Injury Severity Score adjusted in-hospital mortality rates for young patients with EDH were 4.8%. Given the limited information on morbidity resulting from EDH, further analysis to examine modifiable factors for better management and to evaluate survivor's long-term health outcomes via a longitudinal follow-up study is warranted.

Speed cameras for the prevention of road traffic injuries and deaths.

BACKGROUND: It is estimated that by 2020, road traffic crashes will have moved from ninth to third in the world ranking of burden of disease, as measured in disability adjusted life years. The prevention of road traffic injuries is of global public health importance. Measures aimed at reducing traffic speed are considered essential to preventing road injuries; the use of speed cameras is one such measure. OBJECTIVES: To assess whether the use of speed cameras reduces the incidence of speeding, road traffic crashes, injuries and deaths. SEARCH STRATEGY: We searched the following electronic databases covering all available years up to March 2010; the Cochrane Library, MEDLINE (WebSPIRS), EMBASE (WebSPIRS), TRANSPORT, IRRD (International Road Research Documentation), TRANSDOC (European Conference of Ministers of Transport databases), Web of Science (Science and Social Science Citation Index), PsycINFO, CINAHL, EconLit, WHO database, Sociological Abstracts, Dissertation Abstracts, Index to Theses. SELECTION CRITERIA: Randomised controlled trials, interrupted time series and controlled before-after studies that assessed the impact of speed cameras on speeding, road crashes, crashes causing injury and fatalities were eligible for inclusion. DATA COLLECTION AND ANALYSIS: We independently screened studies for inclusion, extracted data, assessed methodological quality, reported study authors' outcomes and where possible, calculated standardised results based on the information available in each study. Due to considerable heterogeneity between and within included studies, a meta-analysis was not appropriate. MAIN RESULTS: Thirty five studies met the inclusion criteria. Compared with controls, the relative reduction in average speed ranged from 1% to 15% and the reduction in proportion of vehicles speeding ranged from 14% to 65%. In the vicinity of camera sites, the pre/post reductions ranged from 8% to 49% for all crashes and 11% to 44% for fatal and serious injury crashes. Compared with controls, the relative improvement in pre/post injury crash proportions ranged from 8% to 50%. AUTHORS' CONCLUSIONS: Despite the methodological limitations and the variability in degree of signal to noise effect, the consistency of reported reductions in speed and crash outcomes across all studies show that speed cameras are a worthwhile intervention for reducing the number of road traffic injuries and deaths. However, whilst the the evidence base clearly demonstrates a positive direction in the effect, an overall magnitude of this effect is currently not deducible due to heterogeneity and lack of methodological rigour. More studies of a scientifically rigorous and homogenous nature are necessary, to provide the answer to the magnitude of effect.

Speed cameras for the prevention of road traffic injuries and deaths.

BACKGROUND: It is estimated that by 2020, road traffic crashes will have moved from ninth to third in the world ranking of burden of disease, as measured in disability adjusted life years. The prevention of road traffic injuries is of global public health importance. Measures aimed at reducing traffic speed are considered essential to preventing road injuries; the use of speed cameras is one such measure. OBJECTIVES: To assess whether the use of speed cameras reduces the incidence of speeding, road traffic crashes, injuries and deaths. SEARCH STRATEGY: We searched the following electronic databases covering all available years up to March 2010; the Cochrane Library, MEDLINE (WebSPIRS), EMBASE (WebSPIRS), TRANSPORT, IRRD (International Road Research Documentation), TRANSDOC (European Conference of Ministers of Transport databases), Web of Science (Science and Social Science Citation Index), PsycINFO, CINAHL, EconLit, WHO database, Sociological Abstracts, Dissertation Abstracts, Index to Theses. SELECTION CRITERIA: Randomised controlled trials, interrupted time series and controlled before-after studies that assessed the impact of speed cameras on speeding, road crashes, crashes causing injury and fatalities were eligible for inclusion. DATA COLLECTION AND ANALYSIS: We independently screened studies for inclusion, extracted data, assessed methodological quality, reported study authors' outcomes and where possible, calculated standardised results based on the information available in each study. Due to considerable heterogeneity between and within included studies, a meta-analysis was not appropriate. MAIN RESULTS: Thirty five studies met the inclusion criteria. Compared with controls, the relative reduction in average speed ranged from 1% to 15% and the reduction in proportion of vehicles speeding ranged from 14% to 65%. In the vicinity of camera sites, the pre/post reductions ranged from 8% to 49% for all crashes and 11% to 44% for fatal and serious injury crashes. Compared with controls, the relative improvement in pre/post injury crash proportions ranged from 8% to 50%. AUTHORS' CONCLUSIONS: Despite the methodological limitations and the variability in degree of signal to noise effect, the consistency of reported reductions in speed and crash outcomes across all studies show that speed cameras are a worthwhile intervention for reducing the number of road traffic injuries and deaths. However, whilst the the evidence base clearly demonstrates a positive direction in the effect, an overall magnitude of this effect is currently not deducible due to heterogeneity and lack of methodological rigour. More studies of a scientifically rigorous and homogenous nature are necessary, to provide the answer to the magnitude of effect.

Electronic data capture using the Womac NRS 3.1 Index (m-Womac): a pilot study of repeated independent remote data capture in OA.

AIM: A preliminary evaluation of mobile phone technology for repeated independent remote data capture using the mobile phone-based m-WOMAC NRS 3.1 Index. METHODS: Following orientation to the m-WOMAC Index, and initial completion in the office, patients took the phones home and independently completed the Index on four subsequent occasions over 12 days, sending their data each time to a server in USA. RESULTS: Three men and nine women with hip (n = 2) and knee (n = 10) OA successfully completed the m-WOMAC Index on each occasion. Average time to completing the Index at termination was 4.8 min. The majority of patients rated logging on/opening the application, completing the m-WOMAC Index on the phone, and sending data as very easy (10-11/12), and were very confident (11/12) in continuing to use the phone to report their symptoms. CONCLUSIONS: These data support the feasibility of repeated independent remote data capture using the m-WOMAC NRS3.1 Index.

Population-based normative values for the Western Ontario and McMaster (WOMAC) osteoarthritis index and the Australian/Canadian (AUSCAN) hand osteoarthritis index functional subscales.

AIM: To develop age- and gender-specific normative values for the physical function subscales of the WOMAC and AUSCAN Indices. METHODS: A scannable survey questionnaire capable of capturing WOMAC and AUSCAN Index and demographic information was developed, pre-tested, and distributed to a stratified random sample of 24,000 members of the Australian general public generated by the Australian Electoral Commission (AEC). RESULTS: Age- and gender-specific WOMAC and AUSCAN normative values were estimated based on approximately 5,500 subjects. Age-related differences were noted at the subscale level. In general, disability increased with age for all items and both Indices. CONCLUSIONS: Normative values provide opportunity for benchmarking the health status of individuals against their age- and gender-matched peers in the general population. These normative values provide unique opportunities, for using the WOMAC and AUSCAN Indices in benchmarking applications, in both clinical practice and research.

Validation of a prediction model to estimate health utilities index Mark 3 utility scores from WOMAC index scores in patients with osteoarthritis of the hip.

OBJECTIVE: To examine the validity of a newly developed prediction model translating osteoarthritis (OA)-specific health-related quality of life (HRQL) scores measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC) into generic utility-based HRQL scores measured using the Health Utilities Index Mark 3 (HUI3). METHODS: Preintervention data from 145 patients with hip OA and complete WOMAC and HUI3 baseline assessments from the Alberta Hip Improvement Project study were used to validate three utility prediction models. These models were estimated using data from a previous study of knee OA patients. Predictive performance was assessed using the mean absolute prediction error (MAE) criterion and several other criteria. RESULTS: The validation sample appeared healthier (on the basis of the HUI3 and WOMAC) than the subjects used toestimate the prediction models. Nevertheless, the validation sample outperformed the predictive performance of the model sample. The results from the validation sample support the conclusions from the original study in that the primary model identified during model development (a model using WOMAC subscales, their interactions, their square terms, age, OA duration, their square terms, and gender) performed better on the MAE criterion than competing models. CONCLUSION: These results support the external validity of the prediction model for the retrospective estimation of HUI3 utility scores for use in economic evaluation.

BLISS index for analyzing knee osteoarthritis trials data.

OBJECTIVES: Different pain thresholds were investigated, using the WOMAC Pain Scale (WOMAC-P) to determine if they could differentiate between treatment groups (hylan G-F 20 vs. appropriate care) at low and very low levels of state attainment in patients with knee osteoarthritis (OA). A method, termed the BLISS (Bellamy et al. Low Intensity Symptom State-attainment) Index, for analyzing OA knee clinical trials data, was proposed. STUDY DESIGN AND SETTING: Five analyses were performed: time to first BLISS day, BLISS days over 12 months, patients with a BLISS response at month 12, patients with a BLISS response at any time, and number of BLISS periods over 12 months. For each analysis, five levels of WOMAC-P were examined:

A multicenter randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injection on pain and function related to knee osteoarthritis (PTA Trial)

INTRODUCTION: Corticosteroid injections (CSIs) are commonly used as an initial or a primary intervention for knee osteoarthritis (OA). Consistent evidence indicates CSIs offer symptom relief with conflicting reports regarding long-term efficacy. Physical therapy (PT) offers a non-invasive alternative. There is moderate evidence suggesting short-term and long-term symptom relief and functional improvement with PT interventions. Patients with knee OA are more commonly prescribed CSI than PT prior to total joint replacement. UnitedHealthcare and Military Health System data show substantially more total knee replacement patients receive preoperative CSI than PT. There are no studies comparing CSI to a PT approach in individuals with knee OA. The primary objective of this study is to compare the effectiveness of CSI to PT in individuals with knee OA at 1, 2 and 12 months. METHODS AND ANALYSIS: We plan to recruit 156 participants meeting established knee OA criteria. Following informed consent, participants will be randomised to receive either CSI or PT. All participants will receive instruction on recommended exercise and weight control strategies plus usual medical care. The CSI intervention consisting of 3 injections and the PT intervention consisting of 8-12 sessions will be spaced over 12 months. Measures of the dependent variables (DVs) will occur at baseline, 4 weeks, 8 weeks, 6 months and 12 months post enrolment. This pragmatic, randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (CSI and PT) and time with five levels from baseline to 1 year. The primary DV is the Western Ontario & McMaster Universities Arthritis Index (WOMAC). We will also compare healthcare utilisation between the 2 groups. ETHICS AND DISSEMINATION: The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The authors intend to publish the results in a peer-reviewed source. TRIAL REGISTRATION NUMBER: NCT01427153.

The Minimum Clinically Important Improvement and Patient-acceptable Symptom State in the BASDAI and BASFI for Patients with Ankylosing Spondylitis.

OBJECTIVE: To establish cutoffs for the minimum clinically important improvement (MCII) and the patient-acceptable symptom state (PASS) for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with ankylosing spondylitis (AS). METHODS: Patients with AS who started nonsteroidal antiinflammatory drugs were included. After 4 weeks, the PASS and the MCII were defined using external anchor questions (for the PASS, patients considering their condition of AS over the prior 48 h as "acceptable" forever; and for the MCII, those reporting moderate or slightly important improvement). Consistency of the MCII and PASS were tested according to HLA-B27 status, presence/absence of SpA extraarticular manifestations, age, sex, disease duration, and baseline BASDAI/BASFI score. The 75th percentile of the cumulative distribution was used to determine the MCII and PASS. RESULTS: In total, 283 patients from a multinational cohort were included. Overall cutoffs for the PASS were 4.1 in the BASDAI and 3.8 in the BASFI. Cutoffs for the MCII were 0.7 and 0.4 for the BASDAI and BASFI, respectively. Subgroup analyses revealed that disease duration and baseline BASDAI/BASFI were significantly associated with the PASS and MCII. In a subanalysis limited to patients with active disease (baseline BASDAI ≥ 4), the MCII was 1.1 for the BASDAI and 0.6 for the BASFI. CONCLUSION: The conceptual viability of the PASS for the BASDAI is questionable because levels approach those required for the start of biological therapy. Because the MCII is less variable than the PASS, we propose its exclusive use, with cutoffs of 1.1/0.6 for the BASDAI/BASFI in patients with active disease. Because these values are based on a subset of the study population, we recommend confirmation in larger studies focused on patients with baseline BASDAI ≥ 4.

Outcome measurement in Australian rehabilitation environments.

OBJECTIVE: To determine the frequency and pattern of methods of outcome assessment used in Australian physical rehabilitation environments. DESIGN: Postal survey. METHODS: A questionnaire on service type, staffing, numbers of adults treated and outcome measures used for 7 conditions related to injury and road trauma as well as stroke and neuromuscular disorders was sent to 973 services providing adult physical rehabilitation treatment. RESULTS: Questionnaires were completed by 440 service providers for a response rate of 45%, similar to that reported in a recent European survey reported in this journal. A small number of measures were reported as in use by most respondents, while a large number of measures were used by a few respondents. Measures of physical changes were used more frequently than those of generic well-being or quality of life. Ease of use and reporting to other professionals were cited as the most important reasons in selection of outcome measures. CONCLUSION: This Australian-wide survey detected considerable heterogeneity in outcome measurement procedures used in rehabilitation environments. While the goal of measurement may vary between providers and differ between conditions, the results highlight opportunities for harmonization, bench-marking and measurement of health-related quality of life.

Validation of the Chinese Western Ontario and McMaster Universities Osteoarthritis Index in Patients From Mainland China With Osteoarthritis of the Knee.

OBJECTIVE: To establish the reliability, validity, and sensitivity to change of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) among Chinese subjects with osteoarthritis (OA) of the knee, living in mainland China. METHODS: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted for validation of the electronic personal digital assistant version of the WOMAC Numerical Rating Scale (NRS) 3.1 Index in China. A total of 287 subjects with OA of the knee were randomized to receive either meloxicam (15 mg) or placebo. Psychometric properties of the WOMAC were evaluated by estimating the reliability, validity, and sensitivity to change. Equivalence of the electronic version was also compared with the paper version. RESULTS: Intraclass correlation coefficients for the WOMAC pain, stiffness, and physical function subscales were 0.81, 0.76, and 0.85, respectively, indicating good test-retest reliability. Similarly, internal consistency was strong (Cronbach's alpha for the 3 WOMAC subscales was 0.84, 0.86, and 0.96, respectively). Pearson's correlation coefficients for WOMAC pain and Short Form 36 health survey (SF-36) bodily pain, as well as WOMAC physical function and SF-36 physical functioning domains were >0.4, indicating convergent validity, whereas the coefficients for all 3 WOMAC domains with SF-36 mental health and mental health component scores were <0.4, indicating divergent validity. There was strong discriminant validity between healthy volunteers and OA patients. The effect sizes of change from baseline to week 12 in WOMAC subscale scores were large, demonstrating sensitivity to change. Equivalence between paper and electronic versions was very high. CONCLUSION: The culturally and linguistically validated Chinese version of the WOMAC NRS 3.1 for mainland China is psychometrically robust in its validity, reliability, and sensitivity to change for patients with OA of the knee.

Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis.

OBJECTIVE: The ability to interpret scores from patient-reported outcome measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state attainment. The goal was to develop multinational estimates for minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS). METHODS: A multinational sample of patients with osteoarthritis (OA) was evaluated before and 4 weeks after treatment with nonsteroidal antiinflammatory drugs. Patients completed either the Western Ontario and McMaster Osteoarthritis Index (WOMAC) numerical rating scale 3.1 (hip and knee OA) or the Australian/Canadian Index (AUSCAN) numerical rating scale 3.1 (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved, from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN indices. RESULTS: A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (percentage) change for MCII ranged 6-9 (10% to 17%) for WOMAC and 4-9 (8% to 15%) for AUSCAN. PASS estimates ranged 39-48 for WOMAC and 38-45 for AUSCAN. Some between-country variation was observed in MCII and PASS. CONCLUSION: Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency, and age- and sex-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions, and other condition-specific outcome measures.