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).

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.

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.

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.

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.

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.

Inclusion of 'minor' trauma cases provides a better estimate of the total burden of injury: Queensland Trauma Registry provides a unique perspective.

INTRODUCTION: Injury is recognised as a frequent cause of preventable mortality and morbidity; however, incidence estimates focusing only on the extent of mortality and major trauma may seriously underestimate the magnitude of the total injury burden. There currently exists a paucity of information regarding minor trauma, and the aim of this study was to increase awareness of the contribution of minor trauma cases to the total burden of injury. METHODS: The demographics, injury details, acute care factors and outcomes of both minor trauma cases and major trauma cases were evaluated using data from the state-wide trauma registry in Queensland, Australia, from 2005 to 2010. The impact of changes in Abbreviated Injury Scale (AIS) versions on the classification of minor and major injury cases was also assessed. RESULTS: Over the 6-year period, minor cases [Injury Severity Score (ISS) ≤ 12] accounted for almost 90% of all trauma included on the Queensland Trauma Registry (QTR). These cases utilised more than half a million acute care bed days, underwent more than 66,500 operations, and accounted for more than 48,000 patient transport episodes via road ambulance, fixed wing aircraft, or helicopter. Furthermore, more than 5800 minor trauma cases utilised in-hospital rehabilitation services; almost 3000 were admitted to an ICU; and more than 20,000 were admitted to hospital for greater than one week. When using the contemporary criteria for classifying trauma (AIS 08), the proportion of cases classified as minor trauma (87.7%) and major trauma (12.3%) were similar to the proportion using the traditional criteria for AIS90 (87.9% and 12.1%, respectively). CONCLUSIONS: This evaluation of minor trauma cases admitted to public hospitals in Queensland detected high levels of demand placed on trauma system resources in terms of acute care bed days, operations, ICU admissions, in-hospital rehabilitation services and patient transportation, and which are all associated with high cost. These data convincingly demonstrate the significant burden of injury imposed by minor trauma cases serious enough to be admitted to hospital.

The University of Queensland study of physical and psychological outcomes for claimants with minor and moderate injuries following a road traffic crash (UQ SuPPORT): design and methods.

BACKGROUND: To date research investigating how mental health impacts physical recovery following a road traffic crash (RTC) has focused on cohorts with severe injuries. The UQ SuPPORT study aims to study the physical and psychological outcomes of claimants with minor injuries following an RTC under the Queensland common law compulsory insurance scheme. OBJECTIVES: This paper outlines the protocols of this study as a platform for future publications. METHODS: The 2-year longitudinal cohort study collected interview and survey data from claimants at 6, 12, and 24 months post-RTC. Measures used in the telephone interview included the DSM-IV Composite International Diagnostic Interview for posttraumatic stress disorder, generalized anxiety disorder, major depressive episode, panic attacks, agoraphobia; and self-reported disability (WHO-DAS-II). Quality of life (SF-36v2), alcohol use (AUDIT), social support (MSPSS), quality-adjusted life years (EQ-5D), and return to work outcomes were assessed via postal questionnaires. RESULTS: A total of 382 claimants consented to participate at the beginning of the study, and these participants were approached at each wave. Retention was high (65%). The average age of participants at Wave 1 was 48.6 years, with 65% of the sample sustaining minor injuries (Injury Severity Score=1-3). CONCLUSIONS: This study has collected a unique sample of data to investigate recovery patterns of claimants with minor injuries. Future publications will more fully assess the effects of the collected measures on recovery rates 2 years post-RTC.

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).

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.

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.

The epidemiology of horse-related injuries for different horse exposures, activities, and age groups in Queensland, Australia.

BACKGROUND: The dangers associated with horse riding, a popular activity throughout Australia, are well documented; yet, few studies have comprehensively described injuries caused by horses to nonriders. This study aimed to facilitate targeted injury prevention strategies and appropriate trauma management by describing all horse-related injuries, for both riders and nonriders, in Queensland, and identifying those at greatest risk. METHODS: Horse-related injury data from 2005 to 2009 were extracted from the Queensland Trauma Registry. Descriptive comparisons were undertaken for demographic, injury, and acute care characteristics between riders and nonriders, between pediatric and adult cases, and between sports/leisure and work injuries. The relative risk of surgery by sex and between riders and nonriders was assessed. RESULTS: More than 25% of injuries occurred in people not riding a horse. Nonriders sustained a significantly higher proportion of internal organ injuries, open wounds, as well as facial and pelvic/abdominal injuries. Females accounted for more than 80% of children who were injured while riding a horse. For adults, 25% were injured while working, and more than 66% of injured workers were male. Injuries most commonly occurred in regional areas. Surgery was most common among children, nonriders, and those with Injury Severity Score (ISS) of 1 to 8. The likelihood of surgery was 25% higher for nonriders (95% confidence interval, 1.14-1.38%). CONCLUSION: Horse-related injuries are most prevalent in identifiable populations, particularly young female riders and adult males injured while working. Injuries inflicted by horses to nonriders contribute more than 27% of all horse-related injuries; however, most previous research has been limited to injured riders. Compared with riders, nonriders more frequently sustain internal, facial, and pelvic injuries; are male; and undergo surgery. The results of this study may be used to tailor prevention strategies and inform trauma management specific to the type of horse exposure, patient age, and activity engaged in when injured. LEVEL OF EVIDENCE: Epidemiologic study, level III.

A comparison of injuries to moped/scooter and motorcycle riders in Queensland, Australia.

BACKGROUND: The popularity of moped and motor scooter riding in Australia is increasing. However, there is a paucity of information about their safety, especially in comparison to motorcycle riding where riders require specific licensing, education and training. Given it is widely established that motorcycle riders are overrepresented in road injury statistics, consideration of moped and scooter riders as a sub-group of all motorcyclists is required for accurate understanding of injury patterns and the acute care needs of this group. METHOD: A comparison of demographic, injury and acute care characteristics between seriously injured moped/scooter riders and motorcycle riders was undertaken using data from the state-wide trauma registry in Queensland, Australia, from 2006 to 2010. RESULTS: A total of 206 moped/scooter riders and 2667 motorcycle riders were identified. Motorcycle rider injury admissions significantly decreased over time (p<0.01), whereas no change was observed for injured moped/scooter riders. Moped/scooter riders sustained a greater percentage of head/neck (+8.6%), facial (+3.0%) and abdominal injuries (+2.3%), whereas motorcycle riders sustained a greater percentage of upper extremity (+4.0%), thoracic (+3.9%), spinal (+3.6%) and lower extremity injuries (+2.6%). There was no statistically significant difference in injury severity, length of acute hospital stay, admission to ICU or survival to discharge from acute care between injured moped/scooter riders and motorcycle riders. CONCLUSION: The results of this study suggest that riders of mopeds/scooters and motorcycles may have different injury patterns, but sustain similar overall injury severity. This analysis fills a gap in transport crash data, where there is limited information on the nature of injuries sustained. While moped-related injuries cannot be isolated in ICD-10 health coding, it is anticipated that ICD-11, due for release in 2015, may provide a moped-specific code; however, this will not address the issue of the apparent interchangeable use of the terms 'moped' and 'scooter' when reporting or documenting such injuries in health data systems including the medical record. Improved identification of moped-related cases in health data is required to increase potential for linkage across health and transport crash data, which may be used for further evaluation of injuries sustained by moped and scooter riders.

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.

Validity and reliability of the Persian versions of WOMAC Osteoarthritis Index and Lequesne Algofunctional Index.

The WOMAC Osteoarthritis Index and Lequesne Algofunctional Index have not been translated and validated for Iranian patients with osteoarthritis (OA) of the knee or hip. The aim of this study was to validate the Persian form of WOMAC OA Index and Lequesne Algofunctional Index and to assess their test-retest reliability and convergent validity. Forward/backward translations and consensus panels were conducted to obtain the Persian versions of WOMAC OA Index and Lequesne Algofunctional Index. A non-probability sample of 116 patients with knee/hip osteoarthritis was asked to complete the WOMAC OA Index and Lequesne Algofunctional Index as well as Medical Outcomes Study-20-Item Short Form (SF-20) questionnaires, a visual analogue scales (VAS) of pain and demographic information form. Internal consistency (using Cronbach's alpha) and convergent validity (by examining the Pearson's correlation coefficients) were evaluated to determine the psychometric properties of the questionnaires. In order to evaluate test-retest reliability, 20 randomly selected patients completed the questionnaires, on a second occasion, 7-10 days later. Cronbach's alpha coefficients and intraclass correlation coefficients for the WOMAC OA Index and Algofunctional Index subscales ranged from 0.63 to 0.94 and from 0.53 to 0.96, respectively. Statistically significant correlations were found between WOMAC OA Index, Algofunctional Index and SF-20 subscales and VAS for pain. The Persian version of WOMAC demonstrated a more acceptable validity, internal consistency and reliability compared with the Lequesne Algofunctional Index. However, both indices are valid and reliable instruments for evaluating the OA severity of knee/hip in Iran.

Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations.

A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.

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.

Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial.

OBJECTIVE: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trials report that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describe the rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis. RESEARCH DESIGN, METHODS, AND RESULTS: This double-blind, placebo-controlled trial (98 centres, 18 countries) includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibiofemoral compartment (Kellgren and Lawrence grade 2 or 3), joint space width (JSW) 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale). Patients are randomly allocated to three groups (strontium ranelate 1 or 2 g/day, or placebo). Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ± 10% between-group difference in change in JSW over 3 years). Recruitment started in April 2006. The results are expected in spring 2012. CLINICAL TRIAL REGISTRATION: The trial is registered on www.controlled-trials.com (number ISRCTN41323372). CONCLUSIONS: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.

Population-based normative values for the Australian/Canadian (AUSCAN) Hand Osteoarthritis Index: part 2.

OBJECTIVES: To develop population-based age- and gender-specific normative values for the pain, stiffness, and physical function subscales of the AUSCAN Index for benchmarking applications. METHODS: A scannable survey questionnaire capable of capturing AUSCAN Index data and demographic information was developed, pretested, and distributed to a stratified random sample of 36,000 members of the Australian general public generated by the Australian Electoral Commission. RESULTS: Age- and gender-specific AUSCAN normative values were estimated based on approximately 7300 subjects. Age-related differences were noted in all 3 AUSCAN subscales. In general, pain, stiffness, and difficulty with physical function percentiles increased with age. CONCLUSIONS: AUSCAN normative values provide opportunity for benchmarking the health status of individuals with hand osteoarthritis against their age- and gender-matched peers in the general population. These normative values provide unique opportunities for using the AUSCAN Index in benchmarking applications, in both clinical practice and research.