A multidisciplinary lifestyle program for metabolic syndrome-associated osteoarthritis: the "Plants for Joints" randomized controlled trial.

OBJECTIVE: To determine the effectiveness of the "Plants for Joints" multidisciplinary lifestyle program in patients with metabolic syndrome-associated osteoarthritis (MSOA). DESIGN: Patients with hip or knee MSOA were randomized to the intervention or control group. The intervention group followed a 16-week program in addition to usual care based on a whole food plant-based diet, physical activity, and stress management. The control group received usual care. The patient-reported Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) total score (range 0-96) was the primary outcome. Secondary outcomes included other patient-reported, anthropometric, and metabolic measures. An intention-to-treat analysis with a linear-mixed model adjusted for baseline values was used to analyze between-group differences. RESULTS: Of the 66 people randomized, 64 completed the study. Participants (84% female) had a mean (SD) age of 63 (6) years and body mass index of 33 (5) kg/m2. After 16 weeks, the intervention group (n = 32) had a mean 11-point larger improvement in WOMAC-score (95% CI 6-16; p = 0.0001) compared to the control group. The intervention group also lost more weight (-5 kg), fat mass (-4 kg), and waist circumference (-6 cm) compared to the control group. Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue, pain interference, C-reactive protein, hemoglobin A1c, fasting glucose, and low-density lipoproteins improved in the intervention versus the control group, while other PROMIS measures, blood pressure, high-density lipoproteins, and triglycerides did not differ significantly between the groups. CONCLUSION: The "Plants for Joints" lifestyle program reduced stiffness, relieved pain, and improved physical function in people with hip or knee MSOA compared to usual care.

Psychometric properties and reference values of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep item banks in the Dutch general population.

Psychometric properties of the v1.0 Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance (27 items) and sleep-related impairment (SRI; 16 items) item banks, short forms derived from the item bank, and simulated computerised adaptive test (CAT), were assessed in a representative sample of 1,006 adults from the Dutch general population. For sleep disturbance all items fitted the item response theory model. Four items showed differential item functioning (i.e., lack of measurement invariance) for age and two for language but the impact on scores (expressed as T-scores) was small. Reliable scores (r > 0.90) were found for 92.2%-96.3% of respondents with the full bank, short forms with six and eight items, and CAT, but for only 25.6% with the four-item short form. For SRI two items did not fit the item response theory model. Four items showed differential item functioning for language but the impact on T-scores was small. Reliable scores were found for 82.1% with the full bank, for 47.8%-69.5% with short forms and CAT. T-scores of 49.7 and 49.3 represent the average score of the Dutch general population for sleep disturbance and SRI, respectively. In conclusion, sufficient structural validity, reliability, and cross-cultural validity was found for the full banks but short forms of four items are not reliable enough for clinical practice. For SRI we recommend the full item bank if this is the primary outcome.

Suitability of the animated activity questionnaire for use as computer adaptive test: establishing the AAQ-CAT.

PURPOSE: The animated activity questionnaire (AAQ) is a computer-based measure of activity limitations. To answer a question, patients choose the animation of a person performing an activity that matches their own level of limitation. The AAQ has not yet been tested for suitability to be applied as computer-adaptive test (CAT). Thus, the objective of this study was to develop and evaluate an AAQ-based CAT to facilitate the application of the AAQ in daily clinical care. METHODS: Patients (n = 1408) with hip/knee osteoarthritis from Brazil, Denmark, France, The Netherlands, Norway, Spain, and the UK responded to all 17 AAQ items. Assumptions of item-response theory (IRT) modelling were investigated. To establish item parameters for the CAT, a graded response model was estimated. To evaluate the performance of post-hoc simulated AAQ-based CATs, precision, test length, and construct validity (correlations with well-established measures of activity limitations) were evaluated. RESULTS: Unidimensionality (CFI = 0.95), measurement invariance (R2-change < 2%), and IRT item fit (S-X2 p > .003) of the AAQ were supported. Performing simulated CATs, the mean test length was more than halved (≤ 8 items), while the range of precise measurement (standard error ≤ 0.3) was comparable to the full AAQ. The correlations between original AAQ scores and three AAQ-CAT versions were ≥ 0.95. Correlations of AAQ-CAT scores with patient-reported and performance measures of activity limitations were ≥ 0.60. CONCLUSION: The almost non-verbal AAQ-CAT is an innovative and efficient tool in patients with hip/knee osteoarthritis from various countries, measuring activity limitations with lower respondent burden, but similar precision and construct validity compared to the full AAQ.

Measurement properties of the Dutch PROMIS-29 v2.1 profile in people with and without chronic conditions.

PURPOSE: To investigate the structural validity, internal consistency, measurement invariance, and construct validity of the Dutch PROMIS-29 v2.1 profile, including seven physical (e.g., pain, physical function), mental (e.g., depression, anxiety), and social (e.g., role functioning) domains of health, in a Dutch general population sample including subsamples with and without chronic diseases. METHODS: The PROMIS-29 was completed by 63,602 participants from the Lifelines cohort study. Structural validity of the PROMIS-29, including unidimensionality of each domain and the physical and mental health summary scores, was evaluated using factor analyses (criteria: CFI ≥ 0.95, TLI ≥ 0.95, RMSEA ≤ 0.06, SRMR ≤ 0.08). Internal consistency, measurement invariance (no differential item functioning (DIF) for age, gender, administration mode, educational level, ethnicity, chronic diseases), and construct validity (hypotheses on known-groups validity and correlations between domains) were assessed per domain. RESULTS: The factor structure of the seven domains was supported (CFI = 0.994, TLI = 0.993, RMSEA = 0.046, SRMR = 0.031) as was unidimensionality of each domain, both in the entire sample and the subsamples. Model fit of the physical and mental health summary scores reached the criteria, and scoring coefficients were obtained. Cronbach's alpha for the seven PROMIS-29 domains ranged from 0.75 to 0.96 in the complete sample. No DIF was detected. Of the predefined hypotheses, 78% could be confirmed. CONCLUSION: Sufficient structural validity, internal consistency and measurement invariance were found, both in the entire sample and in subsamples with and without chronic diseases. Requirements for sufficient evidence for construct validity were (almost) met for most subscales. Future studies should investigate test-retest reliability, measurement error, and responsiveness of the PROMIS-29.

Advances in measuring pediatric overall health: the PROMIS® Pediatric Global Health scale (PGH-7).

In this cross-sectional study, we aimed to assess the reliability, validity, and efficiency of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7) to reduce patient burden when assessing overall health in clinical practice. In total, 1082 children (8-18), representative of the Dutch population, completed the PGH-7 and the Pediatric Quality of Life Inventory (PedsQL™ 4.0), a common legacy instrument used in clinical practice to assess overall health. The assumptions for fitting an item response theory model were assessed: unidimensionality, local independence, and monotonicity. Subsequently, a model was fitted to the data to assess item fit and cultural differential item functioning (DIF) between Dutch and US children. A strong correlation (> .70) was expected between the PGH-7 and PedsQL, as both instruments measure physical, mental, and social domains of health. Percentages of participants reliably measured (> 0.90) were assessed using the standard error of measurement (SE(θ) < 0.32). Efficiency was calculated ((1 - SE(θ)2)/nitems) to compare how well both measures performed relative to number of items administered. The PGH-7 met all assumptions and displayed good structural and convergent (r = .69) validity. One item displayed cultural DIF. Both questionnaires measured reliably (%nPGH-7 = 73.8%, %nPedsQL = 76.6%) at the mean and 2SD in clinically relevant direction. PGH-7 items were 2.6 times more efficient in measuring overall health than the PedsQL.   Conclusion: The PGH-7 displays sufficient validity and reliability in the general Dutch pediatric population and measures more efficiently than the PedsQL, the most commonly used legacy instrument. The PGH-7 can be used in research and clinical practice to reduce patient burden when assessing overall health. What is Known: • Generic instruments which validly and reliably assess overall pediatric health are scarce. • Brief instruments are required for implementation of self-report patient-reported outcomes in clinical practice. What is New: • The PROMIS Pediatric Global Health (PGH-7) can be used in research and clinical practice to briefly assess overall pediatric health, while providing valid and reliable measurements. • The PGH-7 provides more efficient assessment of pediatric overall health than the Pediatric Quality of Life Inventory.

High-intensity versus low-intensity resistance training in patients with knee osteoarthritis: A randomized controlled trial.

OBJECTIVES: To assess whether (i) high-intensity resistance training (RT) leads to increased muscle strength compared to low-intensity RT in patients with knee osteoarthritis (OA); and (ii) RT with vitamin D supplementation leads to increased muscle strength compared to placebo in a subgroup with vitamin D deficiency. DESIGN: Randomized controlled trial. SETTING: Outpatient rehabilitation centre. SUBJECTS: Patients with knee OA. INTERVENTIONS: 12 weeks of RT at high-intensity RT (70-80% of 1-repetition maximum (1-RM)) or low-intensity RT (40-50% of 1-RM) and 24 weeks of vitamin D (1200 International units vitamin D3 per day) or placebo supplementation. MAIN MEASURES: Primary outcome measure was isokinetic muscle strength. Other outcome measure for muscle strength was the estimated 1-RM. Secondary outcome measures were knee pain and physical functioning. RESULTS: 177 participants with a mean age of 67.6 ± 5.8 years were included, of whom 50 had vitamin D deficiency. Isokinetic muscle strength (in Newton metre per kilogram bodyweight) at start, end and 24 weeks after the RT was 0.98 ± 0.40, 1.11 ± 0.40, 1.09 ± 0.42 in the high-intensity group and 1.02 ± 0.41, 1.15 ± 0.42, 1.12 ± 0.40 in the low-intensity group, respectively. No differences were found between the groups, except for the estimated 1-RM in favour of the high-intensity group. In the subgroup with vitamin D deficiency, no difference on isokinetic muscle strength was found between the vitamin D and placebo group. CONCLUSIONS: High-intensity RT did not result in greater improvements in isokinetic muscle strength, pain and physical functioning compared to low-intensity RT in knee OA, but was well tolerated. Therefore these results suggest that either intensity of resistance training could be utilised in exercise programmes for patients with knee osteoarthritis. No synergistic effect of vitamin D supplementation and RT was found, but this finding was based on underpowered data.

Muscle weakness is associated with non-contractile muscle tissue of the vastus medialis muscle in knee osteoarthritis.

BACKGROUND: Quadriceps weakness is assumed to be associated with compositional properties of the vastus medialis muscle in patients with knee osteoarthritis (OA). METHODS: The aim was to determine the association of non-contractile muscle tissue in the vastus medialis muscle, measured with routine MRI, with muscle extensor strength in patients with knee OA. Sagittal T1-weighted 3T MRI of 94 patients with knee OA, routinely acquired in clinical practice were used for analysis. Using the MRI's, the amount of non-contractile muscle tissue in the vastus medialis muscle was measured, expressed as a percentage of (non)-contractile tissue, dichotomized into a low and a high non-contractile percentage group. Muscle strength was assessed by isokinetic measurement of knee extensors and by conduction of the Get-Up and Go (GUG) test. In regression analyses, associations of percentage of non-contractile muscle tissue with muscle strength and GUG time were determined and controlled for sex, age, BMI and radiographic severity. RESULTS: A high percentage of non-contractile muscle tissue (> 11.2%) was associated with lower muscle strength (B = -0.25, P = 0.006) and with longer GUG time (B = 1.09, P = 0.021). These associations were specifically confounded by sex and BMI, because these two variables decreased the regression coefficient (B) with > 10%. CONCLUSIONS: A high percentage of non-contractile muscle tissue in the vastus medialis muscle measured by clinical T1-weighted 3T MRI is associated with muscle weakness. The association is confounded by sex and BMI. Non-contractile muscle tissue seems to be an important compositional property of the vastus medialis muscle underlying quadriceps weakness.

Psychometric properties of the patient-reported outcomes measurement information system scale v1.2: global health (PROMIS-GH) in a Dutch general population.

PURPOSE: To assess the psychometric properties of the Dutch-Flemish Patient-Reported Outcome Measurement Information System Scale v1.2 - Global Health (PROMIS-GH). METHODS: The PROMIS-GH (also referred to as PROMIS-10) was administered to 4370 persons from the Dutch general population. Unidimensionality (CFI ≥ 0.95; TLI ≥ 0.95; RMSEA ≤ 0.06; SRMR ≤ 0.08), local independence (residual correlations < 0.20), monotonicity (H > 0.30), model fit with the Graded Response Model (GRM, p < 0.001), internal consistency (alpha > 0.75), precision (total score information across the latent trait), measurement invariance (no Differential Item Functioning [DIF]), and cross-cultural validity (no DIF for language, Dutch vs. United States English) of its subscales, composed of four items each, Global Mental Health (GMH) and Global Physical Health (GPH), were assessed. RESULTS: Confirmatory factor analyses, on both subscales, revealed slight departures from unidimensionality for GMH (CFI = 0.98; TLI = 0.95, RMSEA = 0.22; SRMR = 0.04) and GPH (CFI = 0.99; TLI = 0.97; RMSEA = 0.12; SRMR = 0.03). Local independence, monotonicity, GRM model fit, internal consistency, precision and cross-cultural validity were supported. However, Global10 (emotional problems) showed misfit on the GMH subscale, while Global08 (fatigue) presented DIF for age. CONCLUSION: The psychometric properties of the PROMIS-GH in the Dutch population were considered acceptable. Sufficient local independence, monotonicity, GRM fit, internal consistency, measurement invariance and cross-cultural validity were found. If future studies find similar results, structural validity of the GMH could be enhanced by improving or replacing Global10 (emotional problems).

Common patient-reported outcomes across ICHOM Standard Sets: the potential contribution of PROMIS®.

BACKGROUND: The International Consortium for Health Outcomes Measurement (ICHOM) develops condition-specific Standard Sets of outcomes to be measured in clinical practice for value-based healthcare evaluation. Standard Sets are developed by different working groups, which is inefficient and may lead to inconsistencies in selected PROs and PROMs. We aimed to identify common PROs across ICHOM Standard Sets and examined to what extend these PROs can be measured with a generic set of PROMs: the Patient-Reported Outcomes Measurement Information System (PROMIS®). METHODS: We extracted all PROs and recommended PROMs from 39 ICHOM Standard Sets. Similar PROs were categorized into unique PRO concepts. We examined which of these PRO concepts can be measured with PROMIS. RESULTS: A total of 307 PROs were identified in 39 ICHOM Standard Sets and 114 unique PROMs are recommended for measuring these PROs. The 307 PROs could be categorized into 22 unique PRO concepts. More than half (17/22) of these PRO concepts (covering about 75% of the PROs and 75% of the PROMs) can be measured with a PROMIS measure. CONCLUSION: Considerable overlap was found in PROs across ICHOM Standard Sets, and large differences in terminology used and PROMs recommended, even for the same PROs. We recommend a more universal and standardized approach to the selection of PROs and PROMs. Such an approach, focusing on a set of core PROs for all patients, measured with a system like PROMIS, may provide more opportunities for patient-centered care and facilitate the uptake of Standard Sets in clinical practice.

Translation, cross-cultural and construct validity of the Dutch-Flemish PROMIS® upper extremity item bank v2.0.

PURPOSE: To develop a Dutch-Flemish translation of the PROMIS® upper extremity (PROMIS-UE) item bank v2.0, and to investigate its cross-cultural and construct validity as well as its floor and ceiling effects in patients with musculoskeletal UE disorders. METHODS: State of the art translation methodology was used to develop the Dutch-Flemish PROMIS-UE item bank v2.0. The item bank and four legacy instruments were administered to 205 Dutch patients with musculoskeletal UE disorders visiting an orthopedic outpatient clinic. The validity of cross-cultural comparisons between English and Dutch patients was evaluated by studying differential item functioning (DIF) for language (Dutch vs. English) with ordinal logistic regression models and McFadden's pseudo R2-change of ≥ 2% as critical value. Construct validity was assessed by formulating a priori hypotheses and calculating correlations with legacy instruments. Floor/ceiling effects were evaluated by determining the proportion of patients who achieved the lowest/highest possible raw score. RESULTS: Eight items showed DIF for language, but their impact on the test score was negligible. The item bank correlated, as hypothesized, moderately with the Dutch-Flemish PROMIS pain intensity item (Pearson's r = - 0.43) and strongly with the Disabilities of the Arm, Shoulder and Hand questionnaire, Subscale Disability/Symptoms (Spearman's ρ = - 0.87), the Functional Index for Hand Osteoarthritis (ρ = - 0.86), and the Michigan Hand Outcomes Questionnaire, Subscale Activities of Daily Living (ρ = 0.87). No patients achieved the lowest or highest possible raw score. CONCLUSIONS: A Dutch-Flemish PROMIS-UE item bank v2.0 has been developed that showed sufficient cross-cultural and construct validity as well as absence of floor and ceiling effects.

PROMIS Physical Function Short Forms Display Item- and Scale-Level Characteristics at Least as Good as the Roland Morris Disability Questionnaire in Patients With Chronic Low Back Pain.

OBJECTIVE: To compare dimensionality, item-level characteristics, scale-level reliability, and construct validity of PROMIS Physical Function short forms (PROMIS-PF) and 24-item Roland Morris Disability Questionnaire (RMDQ-24) in patients with chronic low back pain (LBP). DESIGN: Cross-sectional study. SETTING: Secondary care center for rehabilitation and rheumatology. PARTICIPANTS: Patients with nonspecific LBP ≥3 months (N=768). Mean age was 49±13 years, 77% were female, and 54% displayed pain for more than 5 years. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Dutch versions of the 4-, 6-, 8-, 10-, and 20-item PROMIS-PF and of the RMDQ-24. RESULTS: PROMIS-PF-6, PROMIS-PF-8, and RMDQ-24 exhibited sufficient unidimensionality (confirmatory factor analysis: comparative fit index>0.950, Tucker-Lewis index>0.950, root means square error of approximation<0.060), whereas the other instruments did not. All instruments were free of local dependence except PROMIS-PF-20 with 4 item pairs with clear residual correlations. Mokken scale analysis found 1 nonmonotone item for PROMIS-PF-20 and 8 for RMDQ-24 (ie, the probability of endorsing these items was not increasing with increasing level on the underlying construct). PROMIS-PF-20 displayed 2 misfitting items (S-χ2P value>.001). Two-parameter item response theory models found 2 items with low discrimination for RMDQ-24. All other instruments had adequate fit statistics and item parameters. PROMIS-PF-20 displayed the best scale-level reliability. Construct validity was sufficient for all instruments as all hypotheses on expected correlations with other instruments and differences between relevant subgroups were met. CONCLUSIONS: PROMIS-PF-6, PROMIS-PF-8, and RMDQ-24 exhibited better unidimensionality, whereas PROMIS-PF-4, PROMIS-PF-6, PROMIS-PF-8, and PROMIS-PF-10 showed superior item-level characteristics. PROMIS-PF-20 was the instrument with the best scale-level reliability. This study warrants assessment of other measurement properties of PROMIS-PF short forms in comparison with disease-specific physical functioning instruments in LBP.

Outcomes and potential mechanism of a protocol to optimize foot orthoses in patients with rheumatoid arthritis.

BACKGROUND: Foot problems are highly prevalent in patients with rheumatoid arthritis. Treatment of foot problems related to rheumatoid arthritis often consists of custom made foot orthoses. One of the assumed working mechanisms of foot orthoses is redistribution of plantar pressure by creating a larger weight bearing area. Overall, the reported treatment effect of foot orthoses on foot pain in rheumatoid arthritis is small to medium. Therefore, we developed a foot orthoses optimization protocol for evaluation and adaptation of foot orthoses by using the feedback of in-shoe plantar pressure measurements. The objectives of the present study were: 1) to evaluate the 3-months outcomes of foot orthoses developed according to the protocol on pain, physical functioning and forefoot plantar pressure in patients with foot problems related to rheumatoid arthritis, and 2) to determine the relationship between change in forefoot plantar pressure and change in pain and physical functioning. METHODS: Forty-five patients with foot problems related to rheumatoid arthritis were included and received foot orthoses developed according to the protocol. Outcome measures were assessed at baseline and after three months of wearing foot orthoses in 38 patients. Change scores and effect sizes (ES) were calculated for pain, physical functioning and plantar pressure. In a subgroup of patients with combined forefoot pain and high plantar pressure, the relationship between change in plantar pressure and change in pain and physical functioning was analyzed. RESULTS: In the total group of 38 patients, statistically significant changes in pain (ES 0.69), physical functioning (ES 0.82) and forefoot plantar pressure (ES 0.35) were found. In the subgroup (n = 23) no statistically significant relationships were found between change in plantar pressure and change in pain or physical functioning. CONCLUSION: Foot orthoses developed according to a protocol for improving the plantar pressure redistribution properties lead to medium to large improvements in pain and physical functioning. The hypothesis that more pressure reduction would lead to better clinical outcomes could not be proven.

Factors Associated With Sleep Quality in Patients With Chronic Widespread Pain Attending Multidisciplinary Treatment.

PURPOSE: (1) To investigate the prevalence of poor sleep quality and (2) to explore the associations between clinical, cognitive, and emotional factors and quality of sleep in patients with chronic widespread pain (CWP) receiving multidisciplinary treatment. METHOD: Baseline data were used from 163 patients with CWP referred for multidisciplinary treatment. Linear regression models were used to assess the relationship of clinical (pain, fatigue, pain interference, and disability), emotional (anxiety, depression, and psychological distress), and cognitive factors (catastrophizing, acceptance, self-efficacy, kinesiophobia and illness beliefs) with sleep quality, as measured using the Pittsburgh Sleep Quality Index. RESULTS: Poor sleep quality was found in 92% of the patients. The multivariable model showed that a higher level of fatigue (b = 1.77, standard error [SE] = 0.62, ß = 0.21, t = 2.87, P < 0.01), psychological distress (b = 0.02, SE = 0.01, ß = 0.27, t = 3.50, P < 0.01), and more concerns about the illness (b = 0.46, SE = 0.18, ß = 0.20, t = 2.57, P = 0.01) were independently associated with poorer quality of sleep. The overall linear regression model explains 27.9% of sleep quality. CONCLUSIONS: The high prevalence of poor sleep quality in patients with CWP referred for multidisciplinary treatment emphasizes the need to target sleep during treatment. Further research is needed to disentangle the cause-effect relationship between fatigue, psychological distress, and concerns about the illness and poor sleep (note: this abstract has been published before [Ann Rheum Dis. 2018;77:A1788]).

Differential item functioning of the PROMIS physical function, pain interference, and pain behavior item banks across patients with different musculoskeletal disorders and persons from the general population.

PURPOSE: To investigate the validity of comparisons across patients with different musculoskeletal disorders and persons from the general population by evaluating differential item functioning (DIF) for the PROMIS physical function (PROMIS-PF), pain interference (PROMIS-PI), and pain behavior (PROMIS-PB) item banks. METHODS: Patients with chronic pain, rheumatoid arthritis (RA), or osteoarthritis (OA); patients receiving physiotherapy (PT); and persons from the Dutch general population completed the full Dutch-Flemish PROMIS-PF (121-items), PROMIS-PI (40-items), or PROMIS-PB (39-items) banks. DIF was assessed with ordinal logistic regression models and McFadden's pseudo R2-change of ≥ 2% as critical value. The impact of DIF on item scores and the T-scores per bank was examined by inspecting item characteristic curves (ICCs) and test characteristic curves (TCCs). RESULTS: 2762 patients with chronic pain, 2029 with RA, 1247 with OA, 805 receiving PT, and 1310 healthy persons participated. For the PROMIS-PF, 25 out of 121 items were flagged for DIF, of which 10 items were flagged in multiple comparisons. For the PROMIS-PI, only 2 out of 40 items were flagged for DIF and for the PROMIS-PB, only 3 out of 39 items. Most DIF items had R2 values just above the critical value of 2% and all showed uniform DIF. The ICCs and TCCs showed that the magnitude and impact of DIF on the item and T-scores were negligible. CONCLUSIONS: This study supports the universal applicability of PROMIS across (patient) populations. Comparisons across patients with different musculoskeletal disorders and persons from the general population are valid, when applying the PROMIS-PF, PROMIS-PI, and PROMIS-PB banks.

The immediate effect of a soft knee brace on dynamic knee instability in persons with knee osteoarthritis.

Objectives: Wearing a soft knee brace has been shown to reduce self-reported knee instability in persons with knee OA. There is a need to assess whether a soft knee brace has a beneficial effect on objectively assessed dynamic knee instability as well. The aims of the study were to evaluate the effect of a soft knee brace on objectively assessed dynamic knee instability and to assess the difference in effect between a non-tight and a tight soft knee brace in persons with knee OA. Methods: Thirty-eight persons with knee OA and self-reported knee instability participated in a laboratory study. A within-subject design was used comparing no brace vs brace and comparing a non-tight vs a tight brace. The primary outcome measure was dynamic knee instability, expressed by the perturbation response (PR). The PR reflects deviation in the mean knee varus-valgus angle during level walking after a controlled mechanical perturbation. Linear mixed-effect model analysis was used to evaluate the effect of a brace on dynamic knee instability. Results: Wearing a brace significantly reduced the PR compared with not wearing a brace (B = -0.16, P = 0.01). There was no difference between a non-tight and a tight brace (B = -0.03, P = 0.60). Conclusion: This study is the first to report that wearing a soft knee brace reduces objectively assessed dynamic knee instability in persons with knee OA. Wearing a soft brace results in an objective improvement of knee instability beyond subjectively reported improvement. Trial registration: Nederlands Trial register (trialregister.nl) NTR6363.

Effect of Soft Braces on Pain and Physical Function in Patients With Knee Osteoarthritis: Systematic Review With Meta-Analyses.

OBJECTIVES: To systematically review and synthesize the effects of soft braces on pain and on self-reported and performance-based physical function in patients with knee osteoarthritis. DATA SOURCES: The following electronic databases were searched from inception to April 20, 2016: The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, SPORTDiscus, Web of Science, and PEDro. STUDY SELECTION: Randomized controlled trials (RCTs) and nonrandomized controlled trials (non-RCTs), such as controlled clinical trials, crossover studies, and case-control studies, were included. Two reviewers independently screened articles and determined inclusion through predefined criteria. DATA EXTRACTION: Data related to participant demographics, study design and methods, interventions, and outcomes, including numerical means and SDs, were extracted by 1 reviewer. Methodological quality assessment was independently performed by 2 reviewers. DATA SYNTHESIS: Eleven studies were identified, including 6 RCTs and 5 non-RCTs. The methodological quality of included RCTs was low. There was a moderate improvement in pain (standardized mean difference [SMD]=.52; 95% confidence interval [CI], .14-.89; P=.007; 284 participants) in favor of wearing a brace compared with not wearing a brace for the immediate, within-group comparison. There was a moderate improvement in pain (SMD=.61; 95% CI, .33-.89; P<.001; 206 participants) and a small to moderate improvement in self-reported physical function (SMD=.39; 95% CI, .11-.67; P=.006; 206 participants) in favor of patients receiving a soft brace versus standard care for the prolonged effect, between-group comparison. CONCLUSIONS: Currently available evidence indicates that soft braces have moderate effects on pain and small to moderate effects on self-reported physical function in knee osteoarthritis. These findings highlight the importance of soft braces as a technique to improve pain and physical function in both the short- and long-term. Additional high-quality studies are warranted to improve confidence in the findings.

The effectiveness of therapeutic shoes in patients with rheumatoid arthritis: a systematic review and meta-analysis.

The study summarizes the evidence on the effectiveness of therapeutic shoes on foot function, foot pain, physical functioning, health-related quality of life, adherence, adverse events and patient satisfaction in patients with rheumatoid arthritis (RA). Studies investigating the effect of (ready- or custom-made) therapeutic shoes were included. For between-group designs, studies comparing therapeutic shoes versus non-therapeutic shoes were included. A literature search was conducted in The Cochrane Central Registry for Controlled Trials (CENTRAL), PubMed, EMBASE and PEDro up to January 19, 2017. Quantitative data analysis was conducted; when this was not possible qualitative data analysis was performed. Eleven studies were identified. For custom-made shoes, no studies reporting between-group differences were available. Qualitative data-syntheses of the within-group differences resulted in weak evidence for the reduction of foot pain and improvement of physical functioning. For ready-made shoes, one study reported between-group differences, resulting in inconclusive evidence for improvement of foot function. Quantitative data-analyses of within-group differences resulted in a medium to large effect for the reduction of foot pain (SMD 0.60, 95% CI 0.28-0.92; P ≤ 0.001; 184 participants) and a small to medium effect for the improvement of physical functioning (SMD 0.30, 95% CI 0.04-0.56; P = 0.02; 150 participants). Qualitative data-synthesis of within-group differences resulted in weak evidence for improvement of foot function. Within-group results indicate that therapeutic shoes are likely to be effective in patients with RA. Definitive high-quality RCTs are necessary to investigate the between-group effectiveness of therapeutic shoes in patients with RA.

Analgesic use in patients with knee and/or hip osteoarthritis referred to an outpatient center: a cross-sectional study within the Amsterdam Osteoarthritis Cohort.

Although analgesics are widely recommended in current guidelines, underuse and inadequate prescription of analgesics seem to result in suboptimal treatment effects in patients with knee and/or hip osteoarthritis (OA). This study aimed (i) to describe the use of analgesics; and (ii) to determine factors that are related to analgesic use in patients with knee and/or hip OA referred to an outpatient center. A cross-sectional study with data from 656 patients with knee and/or hip OA referred to an outpatient center (Amsterdam Osteoarthritis (AMS-OA) cohort) was conducted. Self-reported use of analgesic (yes/no) was administered and subdivided into acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs, including coxibs) and opioids. Logistic regression analyses were performed to analyze the association between analgesic use and disease-related, predisposing and enabling factors. Analgesic use was reported by 63% of the patients, with acetaminophen, NSAIDs and opioid use reported by 50, 30 and 12%, respectively. Factors related to analgesic use were higher pain severity, longer duration of symptoms, higher radiographic hip OA severity, overweight/obesity and psychological distress. These factors explained 21% of the variance of analgesic use. More than one-third of patients with established knee and/or hip OA referred to an outpatient center did not use any analgesics. Although multiple, mostly disease-related associated factors were found, analgesic use remained predominantly unexplained. Our study seems to indicate that prescription of analgesics should be guided more dominantly by clinical symptoms and needs, and preceded by a thorough shared decision-making process between patient and physician.

Trend in and predictors for cardiovascular mortality in patients with rheumatoid arthritis over a period of 15 years: a prospective cohort study.

OBJECTIVES: To investigate a) the cardiovascular (CV) mortality in a clinical cohort of patients with established rheumatoid arthritis (RA) in comparison with the general population over 15 years, b) the trend in this CV mortality during the study period, and c) for a broad range of predictors, which baseline variables predict CV mortality. METHODS: In 1997, a sample of 1222 patients was randomly selected from the register of a rheumatology outpatient clinic in Amsterdam. Their CV mortality between 1997 and 2012 was obtained from Statistics Netherlands. The standardised mortality ratio (SMR) for CV mortality was calculated. A linear poisson regression analysis was performed to investigate if there was a trend in SMR over time. A Cox regression analysis was performed to determine which baseline variables predicted CV mortality. RESULTS: Mean age of the population at baseline was 60.4 (SD 15.4) years and 72.6% of the patients were women. Estimated SMR (95% confidence interval) for CV mortality was 1.24 (1.05, 1.43). The SMR decreased with 3% annually (p=0.16). Higher age, higher erythrocyte sedimentation rate, having CV comorbidity and diabetes mellitus (DM) were predictors for CV mortality. CONCLUSIONS: CV mortality among patients with RA in the past 15 years was still higher than in the general population. CV mortality decrease was not statistically significant. As CV mortality in RA is still higher than in the general population, continued attention for CV diseases in RA is important. Both tight control of disease activity and good care for comorbid conditions (CV diseases and DM) are advocated.