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Background: Foot orthoses (FOs) are prescribed as an important conservative treatment option in patients with foot problems related to rheumatoid arthritis. However, a broad variation in FOs is used, both in clinical practice and in research. To date, there is no overview on the outcomes of the treatment with different kinds of FOs in patients with rheumatoid arthritis and a specific foot problem. The objectives of the present study were to summarize the comparative effectiveness of FOs in the treatment of various foot problems in patients with rheumatoid arthritis, on the primary outcomes foot function and foot pain, and the secondary outcomes physical functioning, health related quality of life, compliance, adverse events, the costs of FOs and patient satisfaction. Methods: Studies comparing different kinds of FOs, with a presumed therapeutic effect, in the treatment of foot problems related to rheumatoid arthritis were included. A literature search was conducted in The Cochrane Central Registry for Controlled Trials (CENTRAL), PubMed, EMBASE and PEDro up to May 18th, 2018. Data was meta-analyzed, when this was not possible qualitative data analysis was performed. Results: Ten studies were identified, with a total number of 235 patients. These studies made a comparison between different materials used (soft versus semi-rigid), types of FOs (custom-made versus ready-made; total-contact versus non-total contact), or modifications applied (metatarsal bars versus domes). Also, different techniques to construct custom-made FOs were compared (standard custom-molding techniques versus more sophisticated techniques). A medium effect for (immediate) reduction of forefoot plantar pressure was found in favor of treatment with soft FOs compared to semi-rigid FOs (SMD 0.60, 95% CI 0.07–1.14; P = 0.03; 28 participants). Other comparisons between FOs resulted in non-significant effects or inconclusive evidence for one kind of FOs over the other. Conclusions: Foot orthoses made of soft materials may lead to more (immediate) forefoot plantar pressure reduction compared to foot orthoses constructed of semi-rigid materials. Definitive high quality RCTs, with adequate sample sizes and long-term follow-up, are needed to investigate the comparative (cost-) effectiveness of different kinds of foot orthoses for the treatment of foot problems related to rheumatoid arthritis. [ABSTRACT FROM AUTHOR]

The article presents the authors' reply to the commentary on their article which discusses the restrictions and contraindications on exercise therapy for hip and knee osteoarthritis (OA) patients. Topics discussed include adherence to exercise program, guidelines for hip and knee OA management, and comorbid diseases.

Summary: 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. [ABSTRACT FROM AUTHOR]

Objective: We developed a smartphone application for patients with rheumatoid arthritis (RA) that allows them to self‐monitor their disease activity in between clinic visits by answering a weekly Routine Assessment of Patient Index Data 3. This study was undertaken to assess the safety (noninferiority in the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28‐ESR]) and efficacy (reduction in number of visits) of patient‐initiated care assisted using a smartphone app, compared to usual care. Methods: A 12‐month, randomized, noninferiority clinical trial was conducted in RA patients with low disease activity and without treatment changes in the past 6 months. Patients were randomized 1:1 to either app‐supported patient‐initiated care with a scheduled follow‐up consultation after a year (app intervention group) or usual care. The coprimary outcome measures were noninferiority in terms of change in DAS28‐ESR score after 12 months and the ratio of the mean number of consultations with rheumatologists between the groups. The noninferiority limit was 0.5 difference in DAS28‐ESR between the groups. Results: Of the 103 randomized patients, 102 completed the study. After a year, noninferiority in terms of the DAS28‐ESR score was established, as the 95% confidence interval (95% CI) of the mean ΔDAS28‐ESR between the groups was within the noninferiority limit: −0.04 in favor of the app intervention group (95% CI −0.39, 0.30). The number of rheumatologist consultations was significantly lower in the app intervention group compared to the usual care group (mean ± SD 1.7 ± 1.8 versus 2.8 ± 1.4; visit ratio 0.62 [95% CI 0.47, 0.81]). Conclusion: Patient‐initiated care supported by smartphone self‐monitoring was noninferior to usual care in terms of the ΔDAS28‐ESR and led to a 38% reduction in rheumatologist consultations in RA patients with stable low disease activity. [ABSTRACT FROM AUTHOR]

Introduction: The outcomes anxiety and depression are measured frequently by healthcare providers to assess the impact of a disease, but with numerous instruments. PROMIS item banks provide an opportunity for standardized measurement. Cross-cultural validity of measures and the availability of reference values are prerequisites for standardized measurement. Methods: PROMIS Anxiety and Depression item banks were completed by 1002 representative Dutch persons. To evaluate cross-cultural validity, data from US participants in PROMIS wave 1 were used and differential item functioning (DIF) was investigated, using an iterative hybrid of logistic regression and item response theory. McFadden's pseudo R2-change of 2% was the critical threshold. The impact of any DIF on full item banks and short forms was investigated. To obtain Dutch reference values, T-scores for anxiety and depression were calculated for the complete Dutch sample, and age-group and gender subpopulations. Thresholds corresponding to normal limits, mild, moderate and severe symptoms were computed. Results: In both item banks, two items had DIF but with minimal impact on population level T-scores for full item banks and short forms. The Dutch general population had a T-score of 49.9 for anxiety and 49.6 for depression, similar to the T-scores of 50.0 of the US general population. T-scores for age-group and gender subpopulations were also similar to T-scores of the US general population. Thresholds for mild, moderate and severe anxiety and depression were set to 55, 60 and 70, identical to US thresholds. Conclusions: The limited number of items with DIF and its minimal impact, enables the use of standard (US) item parameters and comparisons of scores between Dutch and US populations. The Dutch reference values provide an important tool for healthcare professionals and researchers to evaluate and interpret symptoms of anxiety and depression, stimulating the uptake of PROMIS measures, and contributing to standardized outcome measurement. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

We evaluated construct validity, responsiveness, and utility of change indicators of the Dutch-Flemish PROMIS adult v1.0 item banks for Depression and Anxiety administered as computerized adaptive test (CAT). Specifically, the CATs were compared to the Brief Symptom Inventory (BSI) using pre- and re-test data of adult patients treated for common mental disorders (N = 400; median pre-to-re-test interval = 215 days). Construct validity was evaluated with Pearson's correlations and Cohen's ds; responsiveness with Pearson's correlations and pre-post effect sizes (ES); utility of change indicators with kappa coefficients and percentages of (dis)agreement. The results showed that the PROMIS CATs measure similar constructs as matching BSI scales. Under the assumption of measuring similar constructs, the CAT and BSI Depression scales were similarly responsive. For the Anxiety scales, we found a higher responsiveness for CAT (ES = 0.64) compared to the BSI (ES = 0.50). Finally, both CATs categorized the change scores of more patients as changed compared to matching BSI scales, indicating that the PROMIS CATs may be more able to detect actual change than the BSI. Based on these findings, the PROMIS CATs may be considered a modest improvement over matching BSI scales as tools for reviewing treatment progress with patients. We discuss several additional differences between the PROMIS CATs and the BSI to help test users choose instruments. These differences include the adopted measurement theory (Item Response Theory vs. Classical Test Theory), the mode of administration (CAT vs. fixed items), and the area of application (universal vs. predominantly clinical). Public Significance Statement: This study suggests that PROMIS CATs for Depression and Anxiety measure the same constructs as matching BSI subscales in Dutch adult patients treated for common mental disorders, are at least as able to detect change over time, and categorize the change scores of more patients as actually changed. Based on these findings, the PROMIS CATs may be considered a modest improvement as tools for reviewing treatment progress with patients. [ABSTRACT FROM AUTHOR]

To study the test-retest reliability and measurement error, construct validity, responsiveness, interpretability, and floor/ceiling effects of a Patient-Reported Outcomes Measurement Information System (PROMIS) short form designed to measure physical function in geriatric rehabilitation patients (PROMIS-PF-GR). Prospective cohort. Inpatient geriatric rehabilitation patients. We evaluated the test-retest reliability by re-administering PROMIS-PF-GR 3 to 5 days after the admission measurement. The intraclass correlation coefficient (ICC) was calculated to determine test-retest reliability; an ICC of ≥0.70 was considered sufficient. Measurement error was established by calculating the standard error of measurement and smallest detectable change. Construct validity and responsiveness were determined by testing a priori formulated hypotheses (criterion: ≥75% hypothesis not rejected). Interpretability was evaluated by calculating the minimal important change using predictive modeling and a global rating as criterion for change. Floor/ceiling effects were established by calculating the percentage patients with the minimum/maximum raw score (criterion: ≤15%) at admission and discharge. A total of 207 patients participated in the study [mean ± standard deviation age (80 ± 8.3 years), 58% female]. More than one-half of patients (56%) reported to be improved during rehabilitation. The ICC was 0.79 (95% confidence interval 0.70–0.84), the standardized error of measurement was 3.8, and the smallest detectable change 10.6. None of the 4 hypotheses for construct validity were rejected; 2 out of 5 hypotheses for responsiveness were rejected. The minimal important change was 8.0 (95% confidence interval 4.1–12.5). No floor/ceiling effects were found. The PROMIS-PG-GR showed sufficient test-retest reliability, measurement error, and construct validity. We did not find sufficient evidence for responsiveness, which may be due to the unexplained weak correlation between the PROMIS change score and the Global Rating Scale. We still recommend the use the PROMIS-PG-GR for measuring self-reported physical function in geriatric rehabilitation. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Study Design: Cross-sectional study, nested in a prospective cohort (Cohort Hip and Knee, CHECK).Objective: Low back pain (LBP) is very common and the main cause of activity limitations and work absence throughout the world. Although lumbar disc degeneration (LDD) is suggested as a cause of LBP, this association remains debatable. Therefore, this study assessed the association between the radiographic features of LDD and the presence of self-reported LBP, LBP persisting longer than 3 months, the perceived severity of LBP and presence of neuropathic pain.Summary Of Background Data: Previous literature suggests an association between LBP and both the LDD definitions osteophytes and disc space narrowing. There are no studies that have explored the association between LDD and neuropathic pain.Methods: Associations between the radiographic LDD using two definitions (i.e., osteophytes, disc space narrowing) versus the presence of LBP, LBP > 3 months, severe LBP and neuropathic pain, were analyzed with logistic regression models.Results: A total of 699 participants completed the questionnaire and had a lumbar radiograph. Radiographs were scored by two independent observers. Osteophytes were present in 98% of the population and disc space narrowing in 67%. Osteophytes were not significantly associated with LBP (OR = 1.2, 95% CI 0.9-1.7). Disc space narrowing was significantly associated with the presence of LBP and neuropathic pain (OR = 1.7, 95% CI = 1.2-2.4 and OR 1.7, 95% CI 1.1-2.7, respectively). The presence of a LBP severity score of ≥4, and LBP persisting > 3 months were not significantly associated with the two definitions of LDD.Conclusion: This study shows the presence of an association between disc space narrowing, whereas no association was found between osteophytes and LBP. We are the first to report an association between disc space narrowing and neuropathic pain.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8-18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch-Flemish.Methods: The translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders.Results: For some items, it was necessary to have separate translations for Dutch and Flemish: physical function-mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items.Conclusion: The Dutch-Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders. [ABSTRACT FROM AUTHOR]

Objectives: Improving foot orthoses (FOs) in patients with rheumatoid arthritis (RA) by using in-shoe plantar pressure measurements seems promising. The objectives of this study were to evaluate (1) the outcome on plantar pressure distribution of FOs that were adapted using in-shoe plantar pressure measurements according to a protocol and (2) the protocol feasibility.Methods: Forty-five RA patients with foot problems were included in this observational proof-of concept study. FOs were custom-made by a podiatrist according to usual care. Regions of Interest (ROIs) for plantar pressure reduction were selected. According to a protocol, usual care FOs were evaluated using in-shoe plantar pressure measurements and, if necessary, adapted. Plantar pressure-time integrals at the ROIs were compared between the following conditions: (1) no-FO versus usual care FO and (2) usual care FO versus adapted FO. Semi-structured interviews were held with patients and podiatrists to evaluate the feasibility of the protocol.Results: Adapted FOs were developed in 70% of the patients. In these patients, usual care FOs showed a mean 9% reduction in pressure-time integral at forefoot ROIs compared to no-FOs (p=0.01). FO adaptation led to an additional mean 3% reduction in pressure-time integral (p=0.05). The protocol was considered feasible by patients. Podiatrists considered the protocol more useful to achieve individual rather than general treatment goals. A final protocol was proposed.Conclusions: Using in-shoe plantar pressure measurements for adapting foot orthoses for patients with RA leads to a small additional plantar pressure reduction in the forefoot. Further research on the clinical relevance of this outcome is required. [ABSTRACT FROM AUTHOR]

Objective. Knee OA has been conceptualized as a multicompartmental disease, as a compartmental disease or as a combination of these two disease processes. The aim of this study was to determine the associations between four radiographic features (joint space narrowing, osteophyte formation, sclerosis and cysts) across and within the three knee compartments (medial tibiofemoral, lateral tibiofemoral and patellofemoral compartment) in knee OA.Methods. Data from the Amsterdam OA Cohort were used. In 298 patients diagnosed with knee OA, radiographic features were examined in three knee joint compartments. Radiographic features were scored according to standardized scoring methods. Factor analysis was used to examine associations between the four radiographic features across and within compartments.Results. A bifactor model showed a general multicompartmental factor: 10 of 12 radiographic features across the entire joint were associated with the general factor. The bifactor model also showed three compartmental factors—one for each compartment: joint space narrowing, sclerosis and to a lesser extent osteophyte formation were associated with these compartmental factors.Conclusion. These findings suggest a multicompartmental disease process in the knee, characterized by associations among features across the entire joint, as well as compartmental disease processes in each knee compartment, characterized by associations among features within specific compartments. Longitudinal studies are needed to explore the possibility of the development from a compartmental disease to a multicompartmental disease and the impact of contributing factors on the development. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Determining “minimally important change” (MIC) facilitates the interpretation of change scores on multi-item instruments. This article focuses on how MIC values should be interpreted when applied to individual patients. Study Design and Setting: The MIC value of a hypothetical questionnaire “Q” was determined in a sample of 400 patients who improved and 100 patients who did not improve, using the receiver operating characteristic (ROC) method, and three methods to quantify the uncertainty. Results: The MIC value on questionnaire Q was 10.5. Firstly, the 95% confidence interval (CI) of the MIC value (for questionnaire Q: 5.6–14.2) quantifies the uncertainty of the estimation of the MIC value. Secondly, “how sure we are that this MIC value holds for every patient” is quantified by the values for sensitivity (74%) and specificity (91%). Thirdly, the smallest detectable change (SDC) on questionnaire Q is calculated (16.0) to consider whether the MIC value (10.5) falls outside or within the measurement error. Conclusion: For application in clinical research and practice, MIC values are always considered at the individual level, but determined in groups of patients. The interpretation comes with different forms of uncertainty. To appreciate the uncertainty, knowledge of the underlying distributions of change scores is indispensable. [Copyright &y& Elsevier]

Introduction: Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is commonly used across medical conditions. To facilitate interpretation of scores across countries, we calculated Dutch reference values for PROMIS Physical Function (PROMIS-PF), Pain Interference (PROMIS-PI), Pain Behavior (PROMIS-PB), Ability to Participate in Social Roles and Activities (PROMIS-APSRA), and Satisfaction with Social Roles and Activities (PROMIS-SSRA), as compared to US reference values., Patients and Methods: A panel completed full PROMIS-PF ( n =1310), PROMIS-PI and PROMIS-PB ( n =1052), and PROMIS-APSRA and PROMIS-SSRA ( n =1002) item banks and reported their level of health per domain (no, mild, moderate, severe limitations). T-scores were calculated by sample and subgroups (age, gender, self-reported level of domain). Distribution-based and anchor-based thresholds for mild, moderate, and severe scores were determined., Results: Mean T-scores were close to the US mean of 50 for PROMIS-PF (49.8) and PROMIS-APSRA (50.6), lower for PROMIS-SSRA (47.5) and higher for PROMIS-PI (54.9) and PROMIS-PB (52.0). Distribution-based thresholds for mild, moderate, and severe scores were comparable to US recommended cut-off values (except for PROMIS-PI) but participants reported limitations 'earlier' than suggested thresholds., Conclusion: Dutch reference values were close to US reference values for some PROMIS domains but not all. We recommend country-specific reference values to facilitate worldwide PROMIS use.KEY MESSAGESPROMIS offers universally applicable IRT-based efficient and patient-friendly measures to assess commonly relevant patient-reported outcomes across medical conditions.To support the use of PROMIS in daily clinical practice and research across the world, country-specific general population reference values should be obtained.More research is necessary to obtain reliable and valid cut-off values for what constitutes mild, moderate and severe scores from the patients' perspective.

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/m 2 . 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., Competing Interests: Conflict of interest The authors report no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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 (R 2 -change < 2%), and IRT item fit (S-X 2 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., (© 2023. The Author(s).)

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., (© 2022. The Author(s).)

Objectives: Most studies of knee osteoarthritis use isokinetic peak strength as a measure of muscle strength. However, estimated one-repetition maximum (1-RM) may have a stronger relationship than isokinetic peak strength with daily activities. The aim of this study was to test the following hypotheses: first, the estimated 1-RM is more strongly associated than isokinetic peak strength with daily activities; and secondly, the estimated 1-RM is most strongly associated with the 6-minute walk test (6MWT), followed by the Get Up and Go test (GUG test) and the stair-climb test., Methods: Data were used for 177 patients with knee osteoarthritis from a randomized controlled trial on improving muscle strength. The patients had a mean age of 67.6 ± 5.8 years. Isokinetic peak strength was measured using a dynamometer, 1-RM was estimated with the 10-RM test, and physical performance was measured with the 6-minute walk test (6MWT), get-up and go test (GUG) test and stair-climb test, at the start and end of 12 weeks of resistance training. Linear regression analyses provided standardized betas (β) that were comparable between the different associations between measures of muscle strength and daily activities., Results: Compared with the estimated 1-RM, isokinetic peak strength was more strongly associated with all performance-based measures. The associations between the estimated 1-RM and performance-based tests were not ranked in the order hypothesized (6MWT, GUG test, stair-climb test)., Conclusion: Contrary to the first hypothesis, isokinetic peak strength showed stronger associations with all daily activities than did estimated 1-RM. In addition, the second hypothesis regarding the activity-specific pattern for the 1-RM with regards walking, chair rising and stair climbing measurements was not confirmed.

Background: To reduce the burden of completing Patient-Reported Outcome Measures (PROMs), PROMIS® Computerized Adaptive Tests (CATs) are being implemented in pediatric clinical practice. We aimed to develop recommendations for visual feedback options for PROMIS CATs on individual item and domain score level as an evidence-based feedback recommendation for PROMIS CATs is lacking., Methods: Focus groups were held with clinicians who use the KLIK PROM portal. Literature-based feedback options were provided to initiate group discussion. Data was analyzed using thematic coding method. Additionally, a questionnaire was sent out to assess patients' (12-18y) and parents' (child 0-18y) preference for individual item feedback. Data was analyzed using descriptive statistics., Results: Six focus groups were held (N = 28 clinicians). Regarding individual item feedback, showing the complete item bank, with only responses to administered items in traffic light colors was preferred. For domain scores, line graphs were preferred, including numerical (T-)scores, reference and cut-off lines, and traffic light colors. Separate graphs per domain, ranked in order of importance and harmonization of directionality ('higher = better') were considered important. Questionnaire results (N = 31 patients/N = 131 parents) showed that viewing their own item responses was preferred above receiving no item feedback by 58.1% of the patients and 77.1% of the parents., Conclusions: Based on the outcomes and after discussion with the Dutch-Flemish PROMIS National Center, recommendations for PROMIS CAT feedback options were developed. PROMIS CATs can now be used in clinical practice to help clinicians monitor patient outcomes, while reducing the burden of completing PROMs for patients significantly., (© 2021. The Author(s).)

Objective: PROMIS offers computerized adaptive tests (CAT) of patient-reported outcomes, using a single set of US-based IRT item parameters across populations and language-versions. The use of country-specific item parameters has local appeal, but also disadvantages. We illustrate the effects of choosing US or country-specific item parameters on PROMIS CAT T-scores., Study Design and Setting: Simulations were performed on response data from Dutch chronic pain patients (n = 1110) who completed the PROMIS Pain Behavior item bank. We compared CAT T-scores obtained with (1) US parameters; (2) Dutch item parameters; (3) US item parameters for DIF-free items and Dutch item parameters (rescaled to the US metric) for DIF items; (4) Dutch item parameters for all items (rescaled to the US metric)., Results: Without anchoring to a common metric, CAT T-scores cannot be compared. When scores were rescaled to the US metric, mean differences in CAT T-scores based on US vs. Dutch item parameters were negligible. However, 0.9%-4.3% of the T-score differences were larger than 5 points (0.5 SD)., Conclusion: The choice of item parameters can be consequential for individual patient scores. We recommend more studies of translated CATs to examine if strategies that allow for country-specific item parameters should be further investigated., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: To add context to the impact of medical conditions, it is important to interpret and compare health outcomes across studies and populations. We aimed to determine Dutch reference values for the Patient-Reported Outcomes Measurement Information System Scale v1.2 - Global Health (PROMIS-GH)., Methods: The PROMIS-GH, also referred to as PROMIS-10, was completed by 4370 Dutch persons, representative for the 2016 Dutch population. T-scores for the mental health (GMH) and physical health (GPH) subscales, and their shorter two-item subscales, were calculated for the entire population, age groups and gender. T-scores for GMH and GPH were compared to the US reference population, representative for the 2000 US general population. Interpretability thresholds for poor, fair, good, very good and excellent GPH and GMH were calculated based on T-scores of participants, which were categorized into five groups based on their response to item Global01. For each group the mean GPH and GMH T-score was calculated and the midpoint between two adjacent means was identified, resulting in thresholds. Thresholds based on the Dutch data were compared to US thresholds., Results: The Dutch population had a GMH T-score of 44.7 and a GPH T-score of 45.2, both substantially worse than the US reference population T-score of 50. Lower T-scores were also found for age-range and gender subpopulations. Dutch GMH and GPH interpretability thresholds were mostly not substantially different compared to the US thresholds, although the Dutch threshold between fair and poor mental health was considerably higher (29 vs. 38)., Conclusions: This study reports reference values for the PROMIS-GH scale for the Dutch general population, including age-range and gender subpopulations. These reference values provide an important tool for healthcare professionals and researchers to better evaluate and interpret patient-reported mental health and physical health. Scores are notably worse than the US reference values. The exact reason for this remains subject for further research, although possibilities for the differences are discussed, including the presence of differential item functioning and the representativeness and recentness of the data.

The Hospital Anxiety and Depression Scale (HADS) is a scale originally developed for the assessment of anxiety and depression in hospitalized patients. Despite its wide diffusion, research on its factorial structure has displayed inconsistent results, leaving doubts about its use in chronic musculoskeletal pain. The purpose of this study was to thoroughly assess the factorial structure of the HADS in patients with chronic pain and to give guidance for a potential refinement. Data from 2,522 patients with chronic pain from the Amsterdam Pain (AMS-PAIN) cohort were analyzed through: 1) exploratory bifactor analysis based on a Schmid-Leiman orthogonalization, 2) confirmatory factor analysis comparing a unidimensional model, the original correlated factors model and a bifactor model, 3) item response theory (IRT) analysis based on the graded response model. The results of the confirmatory factor analysis and of the IRT analysis were then cross-validated in an independent sample of patients with chronic pain (n = 8,604). Both exploratory and confirmatory analyses revealed the presence of a strong general emotional distress factor, suggesting that the HADS can be used as a unidimensional scale. The IRT analysis led to the exclusion of three items and to the recoding of one item. The refined 11-item HADS scale was successfully cross-validated and confirmed as a unidimensional, locally independent, monotonic, and reliable scale. PERSPECTIVE: An 11-item shorter version of the HADS could be used to measure emotional distress in patients with chronic musculoskeletal pain. Given its unidimensionality, the use of its total score seems appropriate., (Copyright © 2019 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease., Objective: The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA., Methods: This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app., Results: Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021., Conclusions: The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care., Trial Registration: Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715., International Registered Report Identifier (irrid): DERR1-10.2196/15105., (©Bart F Seppen, Merel J L'ami, Sharon Duarte dos Santos Rico, Marieke M ter Wee, Franktien Turkstra, Leo D Roorda, Fabio S Catarinella, Dirkjan van Schaardenburg, Michael T Nurmohamed, Maarten Boers, Wouter H Bos. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.02.2020.)

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-χ 2 P 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., (Copyright © 2019 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

We studied the psychometric properties of the 39-item v1.1 Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank in a sample of 1,602 patients with musculoskeletal complaints. We evaluated the assumptions of the underlying item response theory (IRT) model (unidimensionality and local dependency with confirmatory factor analyses), and monotonicity with scalability coefficients). We studied the IRT model fit of all items and estimated the item parameters of the IRT model. Differential item functioning (DIF) was studied for age and gender, and DIF for language was studied as a measure of cross-cultural validity. Confirmatory factor analyses showed suboptimal fit of a unidimensional model, but a bifactor model showed low risk of bias when a unidimensional model was assumed (Omega H = .92, explained common variance of .70). Fifteen item pairs (2%) were locally dependent. Five items showed poor scalability. All items fitted the IRT model; slope parameters ranged from .60 to 2.00, and threshold parameters from -2.05 to 6.80. One item showed DIF for age, 1 item DIF for gender, and 5 items showed DIF for language, but the impact on total scores was low. Our study shows limitations of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank when used in a primary care population with musculoskeletal complaints. PERSPECTIVE: We studied the psychometric properties of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System Pain Behavior item bank in a large primary care population of patients with musculoskeletal complaints. It showed that the Pain Behavior item bank has limitations when used in this population., (Copyright © 2019 the American Pain Society. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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.

Objective: The Animated Activity Questionnaire (AAQ) assesses activity limitations in patients with hip/knee osteoarthritis and consists of video animations; the patients choose the animation that best matches their own performance. The AAQ has shown good validity and reliability. This study aims to evaluate cross-cultural and construct validity of the AAQ., Methods: Cross-cultural validity was assessed using ordinal logistic regression analysis to evaluate differential item functioning (DIF) across 7 languages. Construct validity was assessed by testing correlations between the AAQ and a patient-reported outcome measure (PROM) and performance-based tests., Results: Data from 1,239 patients were available. Compared to the Dutch language (n = 279), none of the 17 items showed DIF in English (n = 202) or French (n = 193), 1 item showed uniform DIF in Spanish (n = 99) and Norwegian (n = 62), and 2 items showed uniform DIF in Danish (n = 201). In all these languages, the occurrence of DIF did not influence the total score, which remained comparable with the original Dutch version. For Italian (n = 203) versus Dutch, however, 6 items showed uniform DIF, and 1 item showed nonuniform DIF, indicating some problems with the cross-cultural validity between these countries. With regard to construct validity, the correlations with PROM (0.74) and performance-based tests (0.36-0.68) were partly as expected (>0.60)., Conclusion: The AAQ, an innovative tool to measure activity limitations that can be placed on the continuum between PROMs and performance-based tests, showed a good overall cross-cultural validity, and seems to have great potential for international use in research and daily clinical practice in many European countries., (© 2016, American College of Rheumatology.)

Objective: The objective of this study was to assess the psychometric properties of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function item bank in Dutch patients with chronic pain., Study Design and Setting: A bank of 121 items was administered to 1,247 Dutch patients with chronic pain. Unidimensionality was assessed by fitting a one-factor confirmatory factor analysis and evaluating resulting fit statistics. Items were calibrated with the graded response model and its fit was evaluated. Cross-cultural validity was assessed by testing items for differential item functioning (DIF) based on language (Dutch vs. English). Construct validity was evaluated by calculation correlations between scores on the Dutch-Flemish PROMIS Physical Function measure and scores on generic and disease-specific measures., Results: Results supported the Dutch-Flemish PROMIS Physical Function item bank's unidimensionality (Comparative Fit Index = 0.976, Tucker Lewis Index = 0.976) and model fit. Item thresholds targeted a wide range of physical function construct (threshold-parameters range: -4.2 to 5.6). Cross-cultural validity was good as four items only showed DIF for language and their impact on item scores was minimal. Physical Function scores were strongly associated with scores on all other measures (all correlations ≤ -0.60 as expected)., Conclusion: The Dutch-Flemish PROMIS Physical Function item bank exhibited good psychometric properties. Development of a computer adaptive test based on the large bank is warranted., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The aims of the study were to (i) determine the prevalence and course of self-reported knee instability at 2-year follow-up and (ii) identify factors predictive of retention of self-reported knee instability among patients with established knee osteoarthritis (OA). Among 201 patients from the Amsterdam Osteoarthritis (AMS-OA) cohort, demographic characteristics, self-reported knee instability, muscle strength, proprioception, pain, and physical function were assessed at baseline and at 2 years. Exercise over the past 2 years was assessed by evaluating the medical files. The course of self-reported knee instability was determined in patients reporting instability at baseline. Baseline predictors of self-reported knee instability were determined by uni- and multivariable logistic regression analyses. At baseline, 123 (61 %) patients reported knee instability, and of these, 85 (64 %) patients reported instability 2 years later, while 38 (29 %) reported no instability 2 years later. Poor proprioception and high pain assessed at baseline predicted retention of self-reported knee instability at 2 years among patients with self-reported instability at baseline. Knee instability is highly prevalent among patients with knee osteoarthritis. In patients with self-reported knee instability, the majority retained instability over 2 years. Poor proprioception and high pain predicted retention of self-reported knee instability over time.

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.

Objective: To systematically summarize the literature on: (i) the course of pain and physical functioning; and (ii) predictors of deterioration of pain and physical functioning in patients with osteoarthritis of the hip., Methods: A literature search was conducted in PubMed, CINAHL, Embase, PsychINFO and SPORTDiscus up to July 2015. Meta-analyses and qualitative data syntheses were performed., Results: Eleven of the 15 included studies were of high quality. With regard to the course of pain and physical functioning, high heterogeneity was found across studies (I² > 71%) and within study populations (reflected by large standard deviations (SDs) of change scores). Therefore, the course of pain and physical functioning was interpreted to be indistinct. Clinical characteristics (higher comorbidity count and presence of knee osteoarthritis), health behaviour factors (no supervised exercise and physical inactivity) and socio-demographics (lower education) were found to predict deterioration of pain (weak evidence). Higher comorbidity count and lower vitality were found to predict deterioration of physical functioning (strong evidence). For several other predictive factors weak evidence was found (e.g. bilateral hip pain, increase in hip pain (change), bilateral knee pain, presence of knee osteoarthritis)., Conclusion: Because of high heterogeneity across studies and within study populations, no conclusions can be drawn with regard to the course of pain and physical functioning. Several clinical characteristics, health behaviours and psychosocial factors prognosticate deterioration of pain and physical functioning. These findings may guide future research aimed at the identification of subgroups of patients with hip osteoarthritis.

The avoidance model in patients with knee and hip osteoarthritis (OA) hypothesizes that pain and psychological distress lead to avoidance of activities, and thereby to muscle weakness and activity limitations. This paper systematically reviews the scientific evidence for the validity of this avoidance model. A qualitative data synthesis was used to identify levels of evidence. Sixty studies were included. In knee OA, strong evidence was found that avoidance of activities is associated with activity limitations via muscle weakness (mediation by muscle weakness), strong evidence was found for an association between muscle weakness and activity limitations, and weak evidence was found that pain and psychological distress are associated with muscle weakness via avoidance of activities (mediation by avoidance). In hip OA, weak evidence was found for mediation by muscle weakness; and strong evidence was found for an association between muscle weakness and activity limitations. More research is needed on the consecutive associations between pain or psychological distress, avoidance of activities and muscle weakness, and to confirm causal relationships.

Objective: To determine whether a decrease in muscle strength over 3 years is associated with an increase in activity limitations in persons with early symptomatic knee osteoarthritis (OA), and to examine whether the longitudinal association between muscle strength and activity limitations is moderated by knee joint proprioception and laxity., Design: A longitudinal cohort study with 3-year follow-up. Measurements were performed at the second (t0) and fifth (t1) year of the Cohort Hip and Cohort Knee (CHECK) study. Statistical analyses included paired t tests, chi-square tests, and regression analyses. In regression analyses, the association between muscle strength and activity limitations was adjusted for confounders., Setting: A rehabilitation and rheumatology center., Participants: Subjects (N=146) with early symptomatic knee OA from the CHECK study., Interventions: Not applicable., Main Outcome Measures: Muscle strength, proprioception, and laxity were assessed using specifically designed measurement devices. Self-reported and performance-based activity limitations were measured with the Western Ontario and McMaster Universities Osteoarthritis Index, the Get Up and Go test, the walk test, and the stair-climb test., Results: A total of 116 women (79.5%) and 30 men (20.5%), with a mean age ± SD of 58.4±4.9 years and a mean body mass index ± SD of 25.5±3.6, were included in the study. Overall, small 3-year changes in muscle strength and activity limitations were observed. At the group level, the average muscle strength increased by 10% (1.0±0.3 to 1.1±0.3Nm/kg) over the 3 years. The 3-year decrease in muscle strength was independently associated with an increase in performance-based activity limitations on all 3 measures (B=-1.12, B=-5.83, and B=-1.25, respectively). Proprioception and laxity did not moderate this association., Conclusions: In patients with early knee OA, decreased muscle strength is associated with an increase in activity limitations. Our results are a step toward understanding the role of muscle weakness in the development of activity limitations in knee OA. Further well-designed experimental studies are indicated to establish the causal role of muscle weakness in activity limitations., (Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objectives: Knee osteoarthritis (OA) is a leading cause of activity limitations. The knee OA population is likely to consist of subgroups. The aim of the present study was to identify homogeneous subgroups with distinct trajectories of activity limitations in patients with early symptomatic knee OA and to describe characteristics of these subgroups., Methods: Follow-up data over a period of 5 years of 697 participants with early symptomatic knee OA from the Cohort Hip and Cohort Knee (CHECK) were used. Activity limitations were measured yearly with the Western Ontario and McMaster Universities Osteoarthritis Index. Latent class growth analyses identified homogeneous subgroups with distinct trajectories of activity limitations. Multivariable regression analyses examined differences in characteristics between the subgroups., Results: Three subgroups were identified. Participants in Subgroup 1 ('good outcome'; n=330) developed or displayed slight activity limitations over time. Participants in Subgroup 2 ('moderate outcome'; n=257) developed or displayed moderate activity limitations over time. Participants in subgroup 3 ('poor outcome'; n=110) developed or displayed severe activity limitations over time. Compared with the 'good outcome' subgroup, the 'moderate outcome' and 'poor outcome' subgroups were characterised by: younger age, higher body mass index, greater pain, bony tenderness, reduced knee flexion, hip pain, osteophytosis, ≥3 comorbidities, lower vitality or avoidance of activities., Conclusions: Based on the 5-year course of activity limitations, we identified homogeneous subgroups of knee OA patients with good, moderate or poor outcome. Characteristics of these subgroups were consistent with existing knowledge on prognostic factors regarding activity limitations, which supports the validity of this classification., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: To study the necessity and ability to climb stairs in persons after a lower-limb amputation (LLA) and the relation of this ability with personal and clinical variables., Design: Cross-sectional study., Setting: Outpatient department of a rehabilitation center., Participants: Persons with an LLA (N=155; mean age ± SD, 64.1 ± 11.2y; 73% men)., Interventions: Not applicable., Main Outcome Measures: The necessity to climb stairs was assessed with the Prosthetic Profile of the Amputee. Several indicators of the ability to climb stairs were assessed including: (1) independence in climbing stairs with a handrail and (2) without a handrail, according to the Locomotor Capabilities Index; (3) numbers of floors actually climbed, according to a rating scale; and (4) limitations in climbing stairs, according to the Climbing Stairs Questionnaire (range, 0-100, with higher scores indicating less limitations). Multivariate logistic regression analysis was used to investigate the associations between the ability to climb stairs and personal and clinical variables., Results: Of the participants, 47% had to climb stairs. The ability to climb stairs was: (1) 62% independently climbed stairs with a handrail and (2) 21% without a handrail; (3) 32% didn't climb any stairs, 34% climbed half a floor or 1 floor, and 34% climbed ≥ 2 floors; (4) the median sum score (interquartile range) of the Climbing Stairs Questionnaire was 38 (19-63), indicating marked limitations. Older participants and women were less able to climb stairs with and without a handrail., Conclusions: A considerable number of persons with an LLA have to climb stairs in their home environment. Many of them, especially older participants and women, are particularly hampered in their ability to climb stairs., (Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To establish whether proprioception and varus-valgus laxity moderate the association between muscle strength and activity limitations in patients with early symptomatic knee osteoarthritis., Design: A cross-sectional study., Subjects: A sample of 151 participants with early symptomatic knee osteoarthritis from the Cohort Hip and Cohort Knee study., Methods: Regression analyses were performed to establish the associations between muscle strength, proprioception (knee joint motion detection threshold in the anterior--posterior direction), varus-valgus laxity and activity limitations (self-reported and performance-based). Interaction terms were used to establish whether proprioception and laxity moderated the association between muscle strength and activity limitations., Results: Proprioception moderated the association between muscle strength and activity limitations: the negative association between muscle strength and activity limitations was stronger in participants with poor proprioception than in participants with accurate proprioception (performance-based activity limitations p = 0.02; self-reported activity limitations p = 0.08). The interaction between muscle strength and varus-valgus laxity was not significantly associated with activity limitations., Conclusion: The results of the present study support the theory that in the absence of adequate proprioceptive input, lower muscle strength affects a patient's level of activities to a greater degree than in the presence of adequate proprioceptive input.

The objective of this study was to evaluate whether self-reported knee instability is associated with activity limitations in patients with knee osteoarthritis (OA), in addition to knee pain and muscle strength. A cohort of 248 patients diagnosed with knee OA was examined. Self-reported knee instability was defined as the perception of any episode of buckling, shifting, or giving way of the knee in the past 3 months. Knee pain was assessed using a numeric rating scale, and knee extensor and flexor strength were measured using an isokinetic dynamometer. Activity limitations were measured by using the Western Ontario and McMasters Universities Osteoarthritis Index physical function questionnaire, the timed Get Up and Go, and the timed stair climbing and three questionnaires evaluating walking, climbing stairs, and rising from a chair. Other potential determinants of activity limitations were also collected, including joint proprioception, joint laxity, age, sex, body mass index (BMI), disease duration, and radiographic disease severity. Regression analyses evaluated the effect of adding self-reported knee instability to knee pain and muscle strength, when examining associations with the activity limitations measures. Self-reported knee instability was common (65 %) in this cohort of patients with knee OA. Analyses revealed that self-reported knee instability is significantly associated with activity limitations, even after controlling for knee pain and muscle strength. Joint proprioception, joint laxity, age, sex, BMI, duration of complaints, and radiographic severity did not confound the associations. In conclusion, self-reported knee instability is associated with activity limitations in patients with knee OA, in addition to knee pain and muscle strength. Clinically, self-reported knee instability should be assessed in addition to knee pain and muscle strength.

Background: Pain-related avoidance of activities is hypothesized to lead to lower muscle strength and thereby activity limitations. Negative affect (e.g., low vitality, depression) is thought to strengthen the tendency to avoid activities., Purpose: The aim of this study was to assess the validity of this "avoidance model" in patients with early symptomatic knee osteoarthritis (OA)., Methods: Cross-sectional data (n=151) were used. The associations between pain, negative affect, avoidance, muscle strength, and activity limitations were modeled using structural equation modeling., Results: Pain and negative affect were associated with lower muscle strength via avoidance (mediation by avoidance). Avoidance was associated with activity limitations via lower muscle strength (mediation by muscle strength). There were also direct associations between pain, negative affect, avoidance, muscle strength, and activity limitations., Conclusions: The results support the validity of the avoidance model, which explains the associations between pain, negative affect, avoidance, muscle strength, and activity limitations in patients with early symptomatic knee OA.

Objectives: The aim of the present study was to describe handwriting difficulties of primary school children with juvenile idiopathic arthritis (JIA), and to investigate possible correlations with hand function and writing performance., Methods: In a cross-sectional approach, 15 children with JIA and reported handwriting difficulties were included together with 15 healthy matched controls. Impairments (signs of arthritis or tenosynovitis, reduced grip force and limited range of motion of the wrist (wrist-ROM)), activity limitations (reduced quality and speed of handwriting, pain during handwriting), and participation restrictions (perceived handwriting difficulties at school) were assessed and analysed., Results: Although selected by the presence of handwriting difficulties, the majority of the JIA children (73%) had no active arthritis of the writing hand, and only minor hand impairments were found. Overall, the JIA children performed well during the short handwriting test, but the number of letters they wrote per minute decreased significantly during the 5-minute test, compared to the healthy controls. JIA patients had significantly higher pain scores on a 100 mm Visual Analogue Scale, compared to the healthy controls. The actual presence of arthritis, and limitation in grip force and wrist-ROM did not correlate with reported participation restrictions with regard to handwriting at school. The JIA children reported pain during handwriting, and inability to sustain handwriting for a longer period of time., Conclusions: The results of this pilot study show that JIA children with handwriting difficulties, experience their restrictions mainly through pain and the inability to sustain handwriting for a longer period of time. No correlations could be found with impairments.