Adaptation of the Banff Patellofemoral Instability Instrument (BPII) 2.0 into Swedish.

BACKGROUND AND PURPOSE: The Banff Patellofemoral Instability Instrument (BPII) 2.0 is a patient-reported outcome measure (PROM) designed specifically for patellofemoral instability. We translated and adapted the BPII 2.0 into Swedish and assessed its psychometric properties. PATIENTS AND METHODS: The BPII 2.0 was forward- and back-translated. Children aged 10-16 years with patellar dislocation and instability or recurrent dislocation were recruited. Children completed the Swedish BPII 2.0 and KOOS-Child during their initial visit (t0) and 1 week later (t1). Internal consistency and test-retest reliability were evaluated using intraclass correlation coefficients (ICCs) for the BPII 2.0 and KOOS-Child scores comparison. Pearson correlation coefficients examined concurrent validity of the Swedish BPII 2.0 subscales with KOOS-Child subscales. RESULTS: 64 children (46 females), mean age 13.8 (10.0-16.3) years, participated. Time after patellar dislocation or surgery was 3-24 months. 55 patients (86%) returned the second BPII 2.0 and KOOS-Child after an average of 9 (5-22) days. There were no ceiling or floor effects for the total score of the new Swedish BPII 2.0 or for its subscales. BPII 2.0 demonstrated excellent internal consistency at t0 (ICC 0.96, 95% confidence interval [CI] 0.95-0.97) and at t1 (ICC 0.97, CI 0.95-0.98), as well as excellent test-retest reliability (ICC 0.97, CI 0.96-0.98). Concurrent validity of the BPII 2.0 subscales with KOOS-Child subscales was moderate to strong (rho 0.40-0.88). CONCLUSION: The Swedish BPII 2.0 showed excellent internal consistency as well as excellent test-retest reliability and is a reliable and valid questionnaire.

Quality improvement for rheumatoid arthritis care: results from a focus group.

OBJECTIVES: Complex treatment decisions in rheumatoid arthritis (RA) affect aspects of patients' physical, psychological and emotional well-being. We aimed to identify key attributes of patient-centered rheumatologic care for adults with RA through a qualitative study using patient focus group discussions in order to guide quality improvement efforts around optimisation of disease management. METHODS: Patients with RA were recruited from a large academic medical centre rheumatology clinic and its affiliate sites over one month and allocated into focus groups led by an experienced moderator. Focus groups were held until thematic saturation was reached. Patients' responses were examined, categorised into themes, and codified independently by three reviewers. We extracted statements identifying common themes from transcripts. RESULTS: Thirteen patients with RA were recruited and allocated into three focus groups. Mean age was 59.1±10.1 years and average RA disease duration was 17.8 years. All participants had experience taking at least one disease-modifying anti-rheumatic drug (DMARD). Following reviewer analysis of patients' responses, six common themes about quality RA care were identified including: the role and use of self-management strategies, the clinical environment, the health care delivery process, attitudes towards medication, insurance and medication access issues, and the impact of disease on lifestyle. CONCLUSIONS: Themes uncovered in focus group discussions related predominantly to the clinical environment and patient-provider communication. These preliminary results identified the need to incorporate operational aspects of health care delivery into our assessment of the RA patient experience and formed the basis of a RA quality improvement programme targeting medication optimisation.

Younger age is associated with greater pain expression among patients with knee or hip osteoarthritis scheduled for a joint arthroplasty.

BACKGROUND: This study describes how patients with knee or hip osteoarthritis (OA), scheduled for arthroplasty, characterize their pain qualitatively and quantitatively and investigates whether differences exist in pain expression between younger and older patients, and between men and women. METHODS: One hundred eight patients scheduled for a joint arthroplasty completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Disability and Osteoarthritis Outcome Score (HOOS) and a health-related quality of life question. Pain was assessed using the visual analogue scale (VAS), KOOS/HOOS and the Pain-o-Meter (POM) consisting of 12 sensory and 11 affective words (POM-Words). Frequency of analgesics use was assessed and preoperative radiographs were graded. ANOVA was used to test differences in pain expression with age (< 65 vs. ≥65 years), sex, and affected joint as independent factors. RESULTS: Patients < 65 years of age used more affective words (POM) and words with higher affective intensity (median scores 8 (3-39), 5.5 (2-27) respectively), than older patients, despite having less radiographically advanced OA. They also reported more symptoms (KOOS/HOOS) than older patients. However, pain ratings, as measured by VAS and KOOS/HOOS pain, did not differ between younger and older adults. Women reported more frequent analgesics use (45.7 and 26.5% respectively) and rated their pain higher than men (mean POM-VAS = 42 (SD 24) and 31 (SD 19); respectively). No differences existed between sexes for sensory or affective POM-Words, or radiographic grade of OA. With age and sex as independent factors, a significant difference between knee and hip OA remained for sensory POM-words intensity scores. CONCLUSIONS: Younger adults scheduled for arthroplasty expressed pain using more affective words and words with higher intensity and had less radiographically advanced OA than older adults. However, VAS and KOOS/HOOS pain subscales could not distinguish the difference in pain expression. Thus, the POM may be a valuable tool for assessment of pain.

Gross Motor Skills in Children With Idiopathic Clubfoot and the Association Between Gross Motor Skills, Foot Involvement, Gait, and Foot Motion.

BACKGROUND: Little is known regarding gross motor skills (GMS) in children with idiopathic clubfoot (IC). This study describes GMS, specifically foot involvement and asymmetries, and analyses the association between GMS, gait, and foot status in children with IC. METHODS: Gross motor tasks and gait were analyzed in children with IC and typically developed (TD) children. GMS were assessed using videotapes and the Clubfoot Assessment Protocol (CAP). The Gait Deviation Index (GDI) and GDI-Kinetic were calculated from gait analyses. Children were divided into bilateral, unilateral clubfoot, or TD groups. To analyze asymmetries, feet within each group were further classified into superior or inferior foot, depending on their CAP scores. Correlations identified associations between CAP and GDI, GDI-Kinetic, passive foot motion, and Dimeglio Classification Scores at birth in the clubfeet. RESULTS: In total, 75 children (mean age, 5 years) were enrolled (bilateral n=22, unilateral clubfoot n=25, TD=28). Children with clubfeet demonstrated significantly lower GMS, gait, and foot motion compared with TD children. One leg standing and hopping deviated in 84% and 91%, respectively, in at least one foot in children with clubfoot. Gross motor asymmetries were evident in both children with bilateral and unilateral involvement. In children with unilateral clubfoot, contralateral feet showed few deviations in GMS compared with TD; however, differences existed in gait and foot motion. The association between GMS and gait, foot motion, and initial foot status varied between poor and moderate. CONCLUSIONS: Gross motor deficits and asymmetries are present in children with both bilateral and unilateral IC. Development of GMS of the contralateral foot mirrors that of TD children, but modifies to the clubfoot in gait and foot motion. The weak association with gait, foot motion, and initial clubfoot severity indicates that gross motor measurements represent a different outcome entity in clubfoot treatment. We therefore, recommend gross motor task evaluation for children with IC. LEVEL OF EVIDENCE: Level II-prognostic studies.

Rapidly increasing incidence in scoliosis surgery over 14 years in a nationwide sample.

PURPOSE: Severe scoliosis is primarily managed with surgery. This cohort study describes the incidence of surgically treated scoliosis among Swedish youth and young adults, stratified by age, sex, scoliosis type, and surgical approach and identifies changes in incidence rate and hospital length of stay (LOS), infections requiring re-surgery and mortality within 90 days. METHODS: Swedish youth, 0-21 years, (n = 3062) with a diagnostic code for scoliosis and spine surgery between 2000 and 2013 were selected from the National Patient Register. Incidence was computed by comparing individuals with surgically treated scoliosis to the total at risk population. Linear regression models and Spearman correlation coefficients analyzed trends over time. RESULTS: Overall annual incidence per 100,000 individuals was 9.1 (5.9 males/12.5 females). Annual incidence increased over 14 years from 5.1 to 9.8; an average 4.6% per year (p < 0.001). Adolescent idiopathic scoliosis was most common (4.5 per 100,000; n = 1516) followed by neuromuscular 2.7 (n = 913) and congenital 0.7 (n = 236). Average LOS decreased among scoliosis types except infantile and neuromuscular scoliosis. Posterior fusion was the most common surgical approach (75%) followed by anterior (18%) and anteroposterior fusion (7%). Posterior fusions significantly increased with a resultant decrease in anterior and anteroposterior fusion over time. Individuals with neuromuscular scoliosis exhibited the highest mortality (n = 12; 1.3%) and (n = 59; 6%) of individuals with neuromuscular scoliosis and (n = 12; 15%) with scoliosis related to MMC required revision surgery due to post-op infection. CONCLUSIONS: Surgical management of scoliosis is increasing with a concurrent decrease in hospital LOS. Surgical management of neuromuscular scoliosis is associated with high 90-day post-operative infections and mortality rate.

Racial Variation in Total Knee Replacement in a Diverse Nationwide Clinical Trial.

OBJECTIVE: Racial variation in total knee replacement (TKR) utilization in the United States has been reported in administrative database studies. We investigated racial variation in TKR procedures in a diverse cohort with severe knee pain followed in an ongoing clinical trial. METHODS: VITAL (VITamin D and OmegA-3 TriaL) is a nationwide, randomized controlled trial of 25,874 adults, 20% of whom are black. We identified a subgroup highly likely to have knee osteoarthritis based on severity of knee pain, physician-diagnosed knee osteoarthritis, and inability to walk 2 to 3 blocks without pain. Participants completed a modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and self-reported incident TKR annually in follow-up. Using Cox regression, we analyzed the association of black versus white race with TKR, adjusting for demographic and socioeconomic characteristics, comorbidities, and WOMAC pain and function. RESULTS: Among 1070 participants who met the inclusion criteria, black participants reported worse baseline WOMAC pain (45 vs. 32, P < 0.001) and worse function (45 vs. 32, P < 0.001). During a median of 3.6 years (interquartile range, 3.2, 3.8 years) of follow-up, TKRs were reported by 180 participants. Black participants were less likely to undergo TKR (11% vs. 19%). After adjustment, the hazard ratio for TKR for black versus white participants was 0.51 (95% confidence interval, 0.32-0.81). Lower use of TKR among black participants was observed across all levels of income and education. CONCLUSIONS: Despite worse baseline knee pain and function, black participants had much lower adjusted risk of having TKR than white participants, demonstrating persistent racial disparity in TKR utilization.

Do virtual reality games improve mobility skills and balance measurements in community-dwelling older adults? Systematic review and meta-analysis.

OBJECTIVE: To summarize evidence on the effectiveness of virtual reality games and conventional therapy or no-intervention for fall prevention in the elderly. DATA SOURCES: An electronic data search (last searched December 2016) was performed on 10 databases (Web of Science, EMBASE, PUBMED, CINAHL, LILACS, SPORTDiscus, Cochrane Library, Scopus, SciELO, PEDro) and retained only randomized controlled trials. REVIEW METHOD: Sample characteristics and intervention parameters were compared, focusing on clinical homogeneity of demographic characteristics, type/duration of interventions, outcomes (balance, reaction time, mobility, lower limb strength and fear of falling) and low risk of bias. Based on homogeneity, a meta-analysis was considered. Two independent reviewers assessed the risk of bias. RESULTS: A total of 28 studies met the inclusion criteria and were appraised ( n: 1121 elderly participants). We found that virtual reality games presented positive effects on balance and fear of falling compared with no-intervention. Virtual reality games were also superior to conventional interventions for balance improvements and fear of falling. The six studies included in the meta-analysis demonstrated that virtual reality games significantly improved mobility and balance after 3-6 and 8-12 weeks of intervention when compared with no-intervention. The risk of bias revealed that less than one-third of the studies correctly described the random sequence generation and allocation concealment procedures. CONCLUSION: Our review suggests positive clinical effects of virtual reality games for balance and mobility improvements compared with no-treatment and conventional interventions. However, owing to the high risk of bias and large variability of intervention protocols, the evidence remains inconclusive and further research is warranted.

Validity of the Nurses' health study physical activity questionnaire in estimating physical activity in adults with rheumatoid arthritis.

BACKGROUND: Patients with rheumatoid arthritis (RA) demonstrate reduced aerobic capacity, excess cardiovascular risk, mobility limitations and are less physically active than their healthy peers. Physical activity may decrease RA disease activity through its anti-inflammatory effects and psychological and health benefits. To successfully manage RA symptoms and reduce cardiovascular risks associated with RA through increased physical activity (PA), accurate physical activity assessments are critical. Accelerometry is an objective physical activity measure, but not widely used. Validity of the Nurses' Health Study physical activity questionnaire II (NHSPAQ) has not been determined for estimation of physical activity in RA. This study examined NHSPAQ validity in adults with RA compared to accelerometry-based metabolic equivalents determined (METs) and results of performance tests. We hypothesized NHSPAQ scores would correlate moderately (0.4-0.5) with accelerometer physical activity estimates. METHODS: Thirty-five adults with RA (mean age [SD] 62 (Williams et. al, Health Qual Life Outcomes 10:28, 2012) years, 28 females (80%) recruited from a hospital-based clinic registry participated in a one-week accelerometry trial. Medical data was compiled. Participants completed the NHSPAQ, a self-paced 20-m walk test, and modified timed step test. Participants wore an accelerometer for 7 consecutive days, then completed a physical activity log and another NHSPAQ. Metabolic equivalents (METs) were derived from NHSPAQ and accelerometers using standardized formulas. NHSPAQ METs were correlated with accelerometer METs and data from performance measures. RESULTS: Average disease duration was 21 years (SD = 11), 63% patients took biologics. The average weekly METs reported were 29 (SD = 33) and accelerometer METs were 33 (SD = 22). NHSPAQ METs correlated moderately with accelerometer-derived METs (r = 0.48 95% CI (0.15-0.70). Self-reported PA correlated moderately with Step Test performance (r = 0.50 95% CI (0.18-0.72). CONCLUSION: Patients with RA exhibit low physical activity levels. General fitness measures were moderately correlated with physical activity levels. A moderate significant correlation existed between NHSPAQ and accelerometry METs. These preliminary data suggest the NHSPAQ may be useful to describe physical activity levels in this population.

Improved knee biomechanics among patients reporting a good outcome in knee-related quality of life one year after total knee arthroplasty.

BACKGROUND: It is not well understood why one in five patients report poor outcomes following knee arthroplasty. This study evaluated changes in knee biomechanics, and perceived pain among patients reporting either a good or a poor outcome in knee-related quality of life after total knee arthroplasty. METHODS: Twenty-eight patients (mean age 66 (SD 7) years) were included in this prospective study. Within one month of knee arthroplasty and one year after surgery, patients underwent three-dimensional (3D) gait analysis, completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), and rated perceived pain using a visual analogue scale. A "good outcome" was defined as a change greater than the minimally detectable change in the KOOS knee-related quality of life, and a "poor outcome" was defined as change below the minimally detectable change. Nineteen patients (68%) were classified as having a good outcome. Groups were analyzed separately and knee biomechanics were compared using a two-way repeated measures ANOVA. Differences in pain between groups were evaluated using Mann Whitney U test. RESULTS: Patients classified as having a good outcome improved significantly in most knee gait biomechanical outcomes including increased knee flexion-extension range, reduced peak varus angle, increased peak flexion moment, and reduced peak valgus moment. The good outcome group also displayed a significant increase in walking speed, a reduction (normalization) of stance phase duration (% of gait cycle) and increased passive knee extension. Whereas, the only change in knee biomechanics, one year after surgery, for patients classified as having a poor outcome was a significant reduction in peak varus angle. No differences in pain postoperatively were found between groups. CONCLUSION: Patients reporting a good outcome in knee-related quality of life improved in knee biomechanics during gait, while patients reporting a poor outcome, despite similar reduction in pain, remained unchanged in knee biomechanics one year after total knee arthroplasty. With regards to surgeon-controlled biomechanical factors, surgery may most successfully address frontal plane knee alignment. However, achieving a good outcome in patient-reported knee-related quality of life may be related to dynamic improvements in the sagittal plane.

Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial.

BACKGROUND: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. OBJECTIVE: To compare Tai Chi with standard physical therapy for patients with knee osteoarthritis. DESIGN: Randomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985). SETTING: An urban tertiary care academic hospital. PATIENTS: 204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). INTERVENTION: Tai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise). MEASUREMENTS: The primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life. RESULTS: At 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred. LIMITATION: Patients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined. CONCLUSION: Tai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.

Deficits in functional performance and gait one year after total knee arthroplasty despite improved self-reported function.

PURPOSE: The current literature lacks sufficient information about improvements in gait patterns and function after total knee arthroplasty (TKA) and whether patients return to full function. This study evaluated change in gait, performance-based function, and self-reported function 1 year after TKA in patients with symptomatic knee osteoarthritis and how these aspects interrelate. METHODS: A total of 28 patients (64 % female) with knee osteoarthritis, with a mean age of 66 (±7) years, and 25 age- and gender-matched controls participated in this prospective cohort study. Three-dimensional gait analysis generated comprehensive measures of kinematic and kinetic gait deviations, respectively. Participants completed the Five Times Sit-to-Stand (5STS) test, and the self-reported questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS), at baseline prior to surgery and 1 year after TKA. RESULTS: Kinetic gait deviations of both the operated and non-operated limb persisted in patients with knee osteoarthritis at 1 year after surgery, while kinematic gait patterns were comparable to controls. Performance on the 5STS and KOOS scores in patients with knee osteoarthritis improved significantly 1 year after surgery (effect size 0.5-1.5), but did not reach the level of controls. Ten patients with knee osteoarthritis (36 %) exceeded the minimally detectable change on the 5STS. CONCLUSION: Measures of overall gait patterns and the 5STS revealed improvements in function 1 year after TKA, but were not restored to the level of healthy controls. Based on change in 5STS performance, we identified patients with substantial improvements in gait patterns. Self-reported measures of function could not detect differences between patients improving in 5STS performance and those who did not. These findings highlight the use of the 5STS in clinical practice since improvement on this test seems to follow the reduction in gait pattern deviations. LEVEL OF EVIDENCE: II.

Physical examination findings and their relationship with performance-based function in adults with knee osteoarthritis.

BACKGROUND: Many physical examination (PE) maneuvers exist to assess knee function, none of which are specific to knee osteoarthritis (KOA). The Osteoarthritis Research Society International also recommends the use of six functional performance measures to assess function in adults with KOA. While earlier studies have examined the relationship between PE findings and self-reported function or PE findings and select performance tests in adults with knee pain and KOA, few have examined the all three types of measures. This cross-sectional study specifically examines the relationships between results of PE findings, functional performance tests and self-reported function in adults with symptomatic KOA. METHODS: We used baseline PE data from a prospective randomized controlled trial in 87 participants aged ≥40 years with symptomatic and radiographic KOA. The PE performed by three experienced physical therapists included: muscle assessment, function and special tests. Participants also completed functional performance tests and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). Multivariate linear regression identified contributions of PE findings towards functional performance and WOMAC scores, adjusting for age and gender. RESULTS: Participants' mean age was 60.4 years (SD = 10.5), mean disease duration was 8.4 years (SD = 10.1) and 27 participants had varus knee alignment. Mean WOMAC pain and function scores were 211 (SD = 113) and 709 (SD = 394), respectively. Weakness was present in major hip and knee muscles. Seventy-nine participants had a positive Ely's, 65 a positive Waldron and 49 a positive Grind. Mean 6-min walk was 404 m (SD = 83) and mean Berg Balance was 53 (SD = 4). Regression analysis identified positive findings on 5 special tests (P < 0.05) as indicative of poorer 6 min walk. Positive Apley's was associated (P < 0.05) with slower 20 m walk and a positive Ober with poorer balance scores (P < 0.05). CONCLUSIONS: Diminished hip muscle strength and flexibility, and patella dysfunction were prevalent in these adults with symptomatic KOA. Results of functional performance tests suggest balance and walking ability are impaired and are associated with PE findings of muscle length imbalance, hip muscle weakness and patella dysfunction. None of the PE measures were associated with self-reported function. Therefore, performance-based test results may be more useful in informing rehabilitation interventions.

Validity and Comprehensibility of Physical Activity Scales for Children With Sport Injuries.

BACKGROUND: Adult physical activity scales are used with children but may not be valid in this population. This study assesses the appropriateness and comprehensibility of currently used physical activity scales in children, identifies sources of response errors, and suggests scale modifications. METHODS: Cognitive interviews were conducted with 30 children who had a lower extremity injury, purposefully sampled based on age and sex. Interviews were conducted to identify children's comprehension of 6 physical activity questionnaires: Tegner activity scale, Cincinnati Knee Rating System, KOOS-Child, Marx activity scale, HSS Pedi-FABS, and KOS sports activity scale. RESULTS: The Tegner scale uses complex activity level descriptions (eg, competitive vs. recreational sports, types of sports and inclusion of work-related physical activity). Activity frequency, description of movement, and sport type in the Cincinnati Knee Rating System led to response mapping issues in many children. Most children felt the KOOS-Child pictures depicting activities were helpful, but not all found the 7-day timeframe relevant. Whereas, most children found the Marx scale and HSS Pedi-FABS items clear, concise, and easy to answer. Children reported difficulties differentiating between endurance and duration items used in the HSS Pedi-FABS. The consistent response format of the KOS sports activity scale was considered a positive attribute although children had trouble comprehending terms such as grating and grinding. CONCLUSIONS: Children found some scales too difficult to answer, whereas others required modifications, particularly in general instruction, language, question format, and mapping (matching an answer to potential options) to adapt to the specific needs of children. LEVEL OF EVIDENCE: Level II.

Psychometric properties of the Knee injury and Osteoarthritis Outcome Score for Children (KOOS-Child) in children with knee disorders.

BACKGROUND: The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-administered valid and reliable questionnaire for adults with joint injury or degenerative disease. Recent data indicate a lack of comprehensibility when this is used with children. Thus, a preliminary KOOS-Child was developed. This study aims to evaluate psychometric properties of the final KOOS-Child when used in children with knee disorders. METHODS: 115 children (boys/girls 51/64, 7-16 years) with knee disorders were recruited. All children (n=115) completed the KOOS-Child, the Child-Health Assessment Questionnaire (CHAQ) and the EQ-5D-Youth version (EQ-5D-Y) at baseline to evaluate construct validity. Two additional administrations (1-3 weeks and 3 months) were performed for analyses of reliability (internal consistency and test-retest; n=72) and responsiveness (n=91). An anchor-based approach was used to evaluate responsiveness and interpretability. RESULTS: After item reduction, the final KOOS-Child consists of 39 items divided into five subscales. No floor or ceiling effects (≤15%) were found. An exploratory factor analysis on subscale level demonstrated that items in all subscales except for Symptoms loaded on one factor (Eigenvalues 3.1-5.5, Symptom: 2 factors, Eigenvalue >1). Sufficient homogeneity was found for all subscales (Cronbach's α = 0.80-0.90) except for the Symptoms subscale (α = 0.59). Test-retest reliability was substantial to excellent for all subscales (Intraclass Correlation Coefficient 0.78-0.91, Smallest Detectable Change (SDC)ind 14.6-22.6, SDCgroup 1.7-2.7). Construct validity was confirmed, and greater effect sizes were seen in those reporting improved clinical status. Minimal important changes greater than the SDCs were found for patients reporting to be better and much better. CONCLUSIONS: The final KOOS-Child demonstrates good psychometric properties and supports the use of the KOOS-Child when evaluating children with knee disorders.

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

BACKGROUND: Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. METHODS/DESIGN: A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. DISCUSSION: This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01258985.

Development of the Knee Injury and Osteoarthritis Outcome Score for children (KOOS-Child): comprehensibility and content validity.

BACKGROUND AND PURPOSE: The Knee Injury and Osteoarthritis Outcome Score (KOOS) is distinguished from other knee-specific measures by the inclusion of separate scales for evaluation of activities of daily living, sports and recreation function, and knee-related quality of life, with presentation of separate subscale scores as a profile. However, its applicability in children has not been established. In this study, we examined how well the KOOS could be understood in a cohort of children with knee injury, with a view to preparing a pediatric version (KOOS-Child). MATERIAL AND METHODS: A trained researcher conducted cognitive interviews with 34 Swedish children who had symptomatic knee injuries (either primary or repeated). They were 10-16 years of age, and were selected to allow for equal group representation of age and sex. All the interviews were recorded. 4 researchers analyzed the data and modified the original KOOS questionnaire. RESULTS: Many children (n =14) had difficulty in tracking items based on the time frame and an equivalent number of children had trouble in understanding several terms. Mapping errors resulted from misinterpretation of items and from design issues related to the item such as double-barreled format. Most children understood how to use the 5-point Likert response scale. Many children found the instructions confusing from both a lexical and a formatting point of view. Overall, most children found that several items were irrelevant. INTERPRETATION: The original KOOS is not well understood by children. Modifications related to comprehension, mapping of responses, and jargon in the KOOS were made based on qualitative feedback from the children.

Physical Activity Interventions in Children with Juvenile Idiopathic Arthritis: A Systematic Review of Randomized Controlled Trials.

Introduction: Children with juvenile arthritis (JA) experience pain, stiffness, fatigue, and decreased motion leading to difficulties with daily activities and low physical activity (PA). PA is critical to improve health and function and mitigate JA-associated symptoms. This study evaluated the evidence for PA interventions in children with JA. Materials and Methods: A systematic review of randomized controlled trials (RCTs) of PA interventions in children with JA was conducted. Ovid (Medline), Cochrane Library, EMBASE, and CINAHL databases were searched for papers published in English between 1/1/1946 and 9/1/2021. Studies which concurrently assessed medical interventions were excluded. Participant and intervention characteristics and outcomes were extracted. Study internal validity and intervention attributes were assessed. Results: A total of 555 studies were identified, with 13 studies from 10 countries included. Data from 672 children diagnosed with juvenile idiopathic arthritis (JIA) (range of mean ages, 8.7 to 16.1 years) were analyzed. Fifty-two percent of intervention arms incorporated strengthening exercise alone or combined with other exercise, with 61.9% performed 3x/week. About 43.5% of sessions lasted >45 to ≤60 minutes and 65.2% of programs were ≥12 to <28 weeks. PA interventions improved function and symptoms without adverse events. Intervention details were missing especially regarding PA intensity, reasons for dropouts, and adherence. Only two studies incorporated strategies to promote adherence. Discussion: RCTs of PA interventions in JA only include JIA. Available RCTs used mixed modes of interventions. Reporting of PA interventions lacks sufficient detail to discern the dose-response relationship. Strategies to motivate engagement in PA and to support families to promote PA are lacking, as are studies of long-term outcomes. Conclusion: There are limited RCTs of PA interventions in JIA. Adherence was better with low intensity programs. PA interventions for JIA yield positive health benefits but better reporting of PA intervention details is needed to generate more high-quality evidence and inform clinical practice. Prospero Registration: Maura Iversen, Johan von Heideken, Marie Andre. Physical Activity in Children with Rheumatic Diseases: a systematic review. PROSPERO 2021 CRD42021274634 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021274634.

Reporting of Adverse Events in Randomized Controlled Trials of Therapeutic Exercise for Hip Osteoarthritis: A Systematic Review.

OBJECTIVE: The purpose of this study was to describe adverse events (AEs) and dropouts (DOs) in randomized controlled trials of therapeutic exercise for hip osteoarthritis (HOA) and to identify whether Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed. METHODS: The Cochrane Library, Embase, PubMed, and CINAHL databases were searched. Randomized controlled trials of therapeutic exercise for HOA published in English from January 1, 1980 to August 1, 2020 were included. Studies were excluded if other interventions were provided, if participants had previous hip arthroplasty, or if AEs and DOs for HOA participants were not reported separately. The internal validity of each study (Physiotherapy Evidence Database [PEDro] scoring) was assessed, participant and intervention characteristics were extracted, and the existence of a clear statement and reasons for AEs and DOs was reported. Descriptive statistics characterized results. Data heterogeneity prohibited the use of meta-analysis. RESULTS: Fourteen studies (mean PEDro score = 7.4; range = 6-10) from 10 countries were included, with 707 participants exercising. Exercise intensity was unspecified in 72.2% of exercise arms. Six studies (42.9%) included a statement of AEs, and 32 AEs were reported. All studies had a DO statement, but 29.0% of DOs occurred for unknown reasons. Six studies (42.9%) gave reasons for DOs that could be classified as AEs in 9 participants; 41 participants (5.8%) experienced exercise-related AEs. CONCLUSION: Reports of AEs were inconsistent, some DOs were potentially misclassified, and primary components of exercise interventions were frequently unreported. Despite these limitations, the overall low number of nonserious AEs suggests that the exercise-related risk of harm is minimal for individuals with HOA. IMPACT: Understanding the risk of harm associated with exercise for HOA can better inform safe dosing of exercise, clinical implementation, and replicability. Informative, consistent reporting of AEs, DOs, and exercise is needed. Greater use of the CONSORT harms-reporting checklist is warranted.

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review.

OBJECTIVE: The Consolidated Standards of Reporting Trials (CONSORT) recommends reporting adverse events (AEs) and dropouts (DOs) with their definitions. The purpose of this study was to identify how AEs and DOs were reported in randomized controlled trials of therapeutic exercise for knee osteoarthritis (OA). METHODS: Data sources were the Cochrane Library, Embase, PubMed, and CINAHL. Databases were searched to identify randomized controlled trials of therapeutic exercise for knee OA published from January 1, 1980, through July 23, 2020. Researchers independently extracted participant and intervention characteristics and determined whether a clear statement of and reasons for AEs and DOs existed. The primary outcome was exercise-related harm. Physiotherapy Evidence Database (PEDro) scoring described study quality and risk of bias. Descriptive and inferential statistics characterized results. Meta-analysis was not performed due to data heterogeneity. RESULTS: One hundred and thirteen studies (152 arms) from 25 countries were included, with 5909 participants exercising. PEDro scores ranged from 4 to 9. Exercise intensity was not specified in 57.9% of exercise arms. Fifty studies (44.2%) included an AE statement and 24 (21.2%) reported AEs, yielding 297 patients. One hundred and three studies (91.2%) had a DO statement. Sixteen studies (15.5%) provided reasons for DOs that could be classified as AEs among 39 patients, yielding a 13.1% increase in AEs. Thus, 336 patients (6.0%) experienced exercise-related harm among studies with a clear statement of AEs and DOs. A significant difference existed in misclassification of DOs pre- and post-CONSORT-2010 (12.2% vs 3.1%; $\chi^{2}_{1} = 21.2$). CONCLUSIONS: In some studies, the reason for DOs could be considered AEs, leading to potential underreporting of harm. Improvements in reporting of harm were found pre- and post-CONSORT-2010. Greater clarity regarding AE and DO definitions and therapeutic exercise intensity are needed to determine safe dosing and mode of therapeutic exercise for knee OA. IMPACT: More adherence to the CONSORT statement is needed regarding reporting of and defining of AEs, DOs, and therapeutic exercise intensity; however, despite this, therapeutic exercise seems to be associated with minimal risk of harm.