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Mariëtte de Rooij,1 Marike van der Leeden,1,2 Ellis Avezaat,3 Arja Häkkinen,4 Rob Klaver,1 Tjieu Maas,5 Wilfred F Peter,1 Leo D Roorda,1 Willem F Lems,1,6 Joost Dekker1,71Amsterdam Rehabilitation Research Center, Reade, Amsterdam, the Netherlands; 2VU University Medical Center Department of Rehabilitation Medicine, Amsterdam, the Netherlands; 3Sint Lucas Andreas Hospital, Department of Physical Therapy, Amsterdam, the Netherlands; 4Department of Health Sciences, University of Jyväskylä and Jyväskylä Central Hospital, Jyväskylä, Finland; 5HAN University, Institute of Health, GGM, Institute for Sports and Exercise Studies, Nijmegen, the Netherlands; 6VU University Medical Center, Department of Rheumatology, Amsterdam, the Netherlands; 7VU University Medical Center, Department of Psychiatry and Department of Rehabilitation Medicine, EMGO Institute, Amsterdam, the NetherlandsBackground: Exercise therapy is generally recommended for patients with osteoarthritis (OA) of the knee. Comorbidity, which is highly prevalent in OA, may interfere with exercise therapy. To date, there is no evidence-based protocol for the treatment of patients with knee OA and comorbidity. Special protocols adapted to the comorbidity may facilitate the application of exercise therapy in patients with knee OA and one or more comorbidities.Purpose: The purpose of this study was to develop comorbidity-adapted exercise protocols for patients with knee OA and comorbidity.Method: Several steps were undertaken to develop comorbidity-adapted protocols: selection of highly prevalent comorbidities in OA, a literature search to identify restrictions and contraindications for exercise therapy for the various comorbid diseases, consultation of experts on each comorbid disease, and field testing of the protocol in eleven patients with knee OA and comorbidity.Results: Based on literature and expert opinion, comorbidity-adapted protocols were developed for highly prevalent comorbidities in OA. Field testing showed that the protocols provided guidance in clinical decision making in both the diagnostic and the treatment phase. Because of overlap, the number of exercise protocols could be reduced to three: one for physiological adaptations (coronary disease, heart failure, hypertension, diabetes type 2, chronic obstructive pulmonary diseases, obesity), one for behavioral adaptations (chronic a-specific pain, nonspecific low back pain, depression), and one for environmental adaptations (visual or hearing impairments). Evaluation of patient outcome after treatment showed significant (P

AIM: The objective of this study was to assess the reliability of a mobility questionnaire (MobQues) that was developed to measure the mobility limitations of children with cerebral palsy (CP) as rated by their parents. A clinical version of the questionnaire, consisting of 47 items (MobQues47), is available, as well as a research version with 28 items for a specific population (MobQues28). Total scores are expressed on a scale of 0 to 100. METHOD: We assessed the interrater reliability between both parents of 289 children with CP (168 males, 121 females, age range 2-13 y, Gross Motor Function Classification System levels I-IV) and the intrarater reliability within a subgroup of 38 parents (of 23 children) who completed the MobQues twice. RESULTS: For the interrater reliability, high intraclass correlation coefficients (ICCs) were found for the MobQues47 (ICC 0.92) and MobQues28 (ICC 0.87). The standard error of measurement (SEM) was 7.8 and 8.9 respectively. As expected, the intrarater reliability was higher, as represented by higher ICCs (0.96-0.99) and lower SEMs (3.5-4.9) for both MobQues versions. INTERPRETATION: The results of this study indicate that the MobQues is a reliable instrument to measure the mobility limitations of children with CP. [ABSTRACT FROM AUTHOR]

Objective: When comparing outcomes of the Functional Independence Measure (FIM[TM]) between patient groups, item characteristics of the FIM[TM] should be consistent across groups. The purpose of this study was to compare item difficulty of the FIM[TM] in 3 patient groups with neurological disorders. Subjects: Patients with stroke ( n =295), multiple sclerosis ( n =150), and traumatic brain injury ( n =88). Methods: FIM[TM] scores were administered in each group. The FIM[TM] consists of a motor domain (13 items) and a cognitive domain (5 items). Rasch rating scale analysis was performed to investigate differences in item difficulty (differential item functioning) between groups. Results: Answering categories of the FIM[TM] items were reduced to 3 (from the original 7) because of disordered thresholds and low answering frequencies. Two items of the motor domain ('bladder' and 'bowel') did not fit the Rasch model. For 7 out of the 11 fitting motor items, item difficulties were different between groups (i.e. showed differential item functioning). All cognitive items fitted the Rasch model, and 4 out of 5 cognitive items showed differential item functioning. Conclusion: Differential item functioning is present in several items of both the motor and cognitive domain of the FIM[TM]. Adjustments for differential item functioning may be required when FIM[TM] data will be compared between groups or will be used in a pooled data analysis. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the test-retest reliability of two questionnaires for measuring activity limitations in patients with Complex Regional Pain Syndrome type 1 (CRPS I) of the lower extremity. DESIGN: Patients filled out the Walking Stairs Questionnaire and the Questionnaire Rising and Sitting Down twice during a one-week period. SETTING: Outpatient pain clinic of a university hospital. PATIENTS: Twenty-one outpatients with CRPS I of the lower extremity. RESULTS: The Walking Stairs Questionnaire and the Questionnaire Rising and Sitting Down were reliable in terms of test-retest reliability as expressed by Spearman's r (range 0.79-0.90 and 0.85-0.89 respectively) and the ICC (range 0.78-0.84 and 0.84-0.87 respectively). CONCLUSION: Both questionnaires form a reliable tool for measuring activity limitations of patients with CRPS I of a lower extremity. [ABSTRACT FROM AUTHOR]

AIM: the objective of this study was to assess the validity of a mobility questionnaire (MobQues) that was developed to measure parent-reported mobility limitations in children with cerebral palsy (CP). METHOD: the parents of 439 children with CP (256 males and 183 females; age range 2-18y; Gross Motor Function Classification System [GMFCS] levels I-IV) completed the mobility questionnaire (MobQues). To assess content validity, we linked all meaningful concepts of the MobQues items to the International Classification of Functioning, Disability and Health (ICF). To assess construct validity, we compared the total scores of the two versions of the MobQues (MobQues47 and MobQues28) according to GMFCS level, and determined Pearson's correlation coefficient (r) with the Gross Motor Function Measure-66 (GMFM-66). RESULTS: content validity was demonstrated by the fact that 46 of the 47 MobQues items were linked to categories in the 'Mobility' chapter of the ICF. Construct validity was demonstrated by the finding that MobQues scores decreased with increasing GMFCS levels (p<0.001). In a subgroup of 162 children, positive correlations were found between total scores and the GMFM-66 (MobQues47, r=0.75; MobQues28, r=0.67, p<0.001). INTERPRETATION: the results of this study provide evidence supporting the content and construct validity of the MobQues as a measure of mobility limitation in children with CP. [ABSTRACT FROM AUTHOR]

Background: Several Patient Reported Outcome Measurements (PROMs) can be used to quantify participation in rehabilitation patients, yet there is limited comparative research on their content and psychometric properties to make an informed decision between them., Objective: To compare the content and several psychometric properties of the Restriction and Satisfaction subscales of the Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) with the Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities (PROMIS-APS) and Satisfaction with Social Roles and Activities (PROMIS-SPS) v2.0 8-item short forms., Methods: A cross-sectional survey among patients who received rehabilitation treatment ( N  = 563). Coverage of participation domains, distributions, inter-item correlations, internal consistency, construct validity, and discriminative validity were compared between the PROMs., Results: The USER-P subscales cover more participation domains than the PROMIS short forms. All PROMs demonstrated adequate internal consistency ( α  > 0.82) and each had >75% of the hypotheses regarding construct validity confirmed., Conclusions: The internal consistency, construct and discriminative validity were similar between the USER-P subscales and the PROMIS short forms. It appeared that the USER-P offers more broad information about participation on item level and the total scores of PROMIS short forms offer more precise general information regarding participation.

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).)

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., (© 2022 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

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).)

Purpose: This study aims to systematically review and critically appraise the content validity of the adult versions of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) item bank and its derivative measures in any adult population., Methods: MEDLINE and EMBASE were searched in October 2021 for studies on measurement properties of PROMIS-PF measures in an adult population. Studies were included if the study described the development of a PROMIS-PF measure or investigated its relevance, comprehensiveness, or comprehensibility. Assessment of the methodological quality of eligible studies, rating of results, and summarizing evidence was performed following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for assessing content validity. A modified GRADE approach was used to determine the level of evidence., Results: Three development studies and eight studies on the content validity of one or more of the PROMIS-PF measures were identified. The methodological quality of most studies was rated doubtful. There was low to high level evidence for sufficient relevance, comprehensiveness, and comprehensibility of most PROMIS-PF measures for healthy seniors and various disease populations. We found low to moderate level evidence for insufficient relevance of PROMIS-PF measures for patients with conditions that affected only one body part, and insufficient comprehensibility of the PROMIS-PF measures for minority elderly., Conclusion: Most PROMIS-PF measures demonstrate sufficient content validity in healthy seniors and various disease populations. However, the quality of this evidence is generally low to moderate, due to limitations in the methodological quality of the studies., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

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., (© 2022 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

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., Competing Interests: CB Terwee and LD Roorda are members of the PROMIS Health Organization and the Dutch-Flemish PROMIS National Center, which aim to improve health outcomes by developing, maintaining, improving, and encouraging the application of PROMIS in research and clinical practice. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The other authors have no conflict of interest.

Objective: The present study aimed to create a shorter version of the Action Research Arm Test (ARAT) without compromising its measurement properties., Design: Secondary analysis of stroke recovery cohorts that used the ARAT to measure upper limb impairment., Setting: Rehabilitation centers., Participants: Patients with stroke from 5 different stroke recovery cohorts (N=1425)., Interventions: Not applicable., Main Outcome Measures: A decision tree version of the ARAT (ARAT-DT) was developed using chi-square automated interaction detection. In an independent validation subset, criterion validity, agreement of ARAT-DT with original ARAT scores and score categories, and construct validity with the Fugl-Meyer Upper Extremity Scale score were determined., Results: In total, 3738 ARAT measurements were available involving 1425 subjects. Chi-square automated interaction detection analysis in the development subset (n=2803) revealed an optimized decision tree with a maximum of 4 consecutive items. In the validation data set (n=935), the ARAT-DT differed by a mean of 0.19 points (0.3% of the total scale) from the original ARAT scores (limits of agreement=-5.67 to 6.05). The ARAT-DT demonstrated excellent criterion validity with the original ARAT scores (intraclass correlation coefficient=0.99 and ρ=0.99) and scoring categories (κ w =0.97). The ARAT-DT showed very good construct validity with the Fugl-Meyer Upper Extremity Scale (ρ=0.92)., Conclusion: A decision tree version of the ARAT was developed, reducing the maximum number of items necessary for ARAT administration from 19 to 4. The scores produced by the decision tree had excellent criterion validity with original ARAT scores., Competing Interests: Declaration of Competing Interest None., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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.

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.

Purpose: A spinal cord injury (SCI) has a large impact on a person's physical, psychological, and social health. Previous studies focused on physical recovery in patients with SCI and assessed their health-related quality of life (HRQOL) with general questionnaires, which often contain irrelevant questions. The SCI-QOL questionnaire was developed to specifically assess the HRQOL of the SCI population. A comprehensive translation and cross-cultural adaptation are required to use this questionnaire in the Netherlands and Flanders, Belgium., Methods: All 23 short forms of the SCI-QOL for adults were translated from English into Dutch-Flemish using the Functional Assessment of Chronic Illness Therapy translation methodology, with a cognitive debriefing being performed with 10 patients with SCI and 10 persons from the general population., Results: The Dutch-Flemish PROMIS group previously translated 46 of the 207 items in the 23 short forms. Here, we achieved an acceptable translation of the other 161 items. A single Dutch-Flemish translation was obtained for 20 short forms, while separate Dutch and Flemish translations were necessary for the short forms Ambulation, Manual Wheelchair, and Stigma., Conclusion: The Dutch-Flemish translation of the SCI-QOL is now available for clinical and research purposes. Future studies should focus on the psychometric properties of this cross-culturally adapted version., (© 2022. The Author(s).)

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 )/n items ) 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 (%n PGH-7  = 73.8%, %n PedsQL  = 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., (© 2022. The Author(s).)

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., (© 2022. The Author(s).)

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 d s; 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). (PsycInfo Database Record (c) 2022 APA, all rights reserved).

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)., (© 2021. The Author(s).)

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., (© 2021. The Author(s).)

Objectives: 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)., Design: Prospective cohort., Setting and Participants: Inpatient geriatric rehabilitation patients., Methods: 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., Results: 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., Conclusions and Implications: 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., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

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.

Objectives: Osteoarthritis (OA) of the foot-ankle complex is understudied. Understanding determinants of pain and activity limitations is necessary to improve management of foot OA. The aim of the present study was to investigate demographic, foot-specific and comorbidity-related factors associated with pain and activity limitations in patients with foot OA., Methods: This exploratory cross-sectional study included 75 patients with OA of the foot and/or ankle joints. Demographic and clinical data were collected with questionnaires and by clinical examination. The outcome variables of pain and activity limitations were measured using the Foot Function Index (FFI). Potential determinants were categorized into demographic factors (e.g., age, sex), foot-specific factors (e.g., plantar pressure and gait parameters), and comorbidity-related factors (e.g., type and amount of comorbid diseases). Multivariable regression analyses with backward selection (p-out≥0.05) were performed in two steps, leading to a final model., Results: Of all potential determinants, nine factors were selected in the first step. Five of these factors were retained in the second step (final model): female sex, pain located in the hindfoot, higher body mass index (BMI), neurological comorbidity, and Hospital Anxiety and Depression Scale (HADS) score were positively associated with the FFI score. The explained variance ( R 2 ) for the final model was 0.580 (adjusted R 2  ​= ​0.549)., Conclusion: Female sex, pain located in the hindfoot, higher BMI, neurological comorbidity and greater psychological distress were independently associated with a higher level of foot-related pain and activity limitations. By addressing these factors in the management of foot OA, pain and activity limitations may be reduced., Competing Interests: The authors have no competing interests to declare., (© 2021 The Authors.)

Objective: To assess the psychometric properties of 8 pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) item banks in a clinical sample of children with juvenile idiopathic arthritis (JIA)., Methods: A total of 154 Dutch children (mean ± SD age 14.4 ± 3.0 years; range 8-18 years) with JIA completed 8 pediatric version 1.0 PROMIS item banks (anger, anxiety, depressive symptoms, fatigue, pain interference, peer relationships, physical function mobility, physical function upper extremity) twice and the Pediatric Quality of Life Inventory (PedsQL) and the Childhood Health Assessment Questionnaire (C-HAQ) once. Structural validity of the item banks was assessed by fitting a graded response model (GRM) and inspecting GRM fit (comparative fit index [CFI], Tucker-Lewis index [TLI], and root mean square error of approximation [RMSEA]) and item fit (S-X 2 statistic). Convergent validity (with PedsQL/C-HAQ subdomains) and discriminative validity (active/inactive disease) were assessed. Reliability of the item banks, short forms, and computerized adaptive testing (CAT) was expressed as the SE of theta (SE[θ]). Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) and smallest detectable change., Results: All item banks had sufficient overall GRM fit (CFI >0.95, TLI >0.95, RMSEA <0.08) and no item misfit (all S-X 2 P > 0.001). High correlations (>0.70) were found between most PROMIS T scores and hypothesized PedsQL/C-HAQ (sub)domains. Mobility, pain interference, and upper extremity item banks were able to discriminate between patients with active and inactive disease. Regarding reliability, PROMIS item banks outperformed legacy instruments. Post hoc CAT simulations outperformed short forms. Test-retest reliability was strong (ICC >0.70) for all full-length item banks and short forms, except for the peer relationships item bank., Conclusion: The pediatric PROMIS item banks displayed sufficient psychometric properties for Dutch children with JIA. PROMIS item banks are ready for use in clinical research and practice for children with JIA., (© 2019 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.)

Objective: Pain interference and pain behavior are highly relevant outcomes in patients with rheumatoid arthritis (RA). The Patient-Reported Outcomes Measurement Information System (PROMIS) is a universally applicable set of item banks measuring patient-reported health, and if applied as computerized adaptive tests (CATs), more efficiently and precisely than current instruments. The objective was to study the psychometric properties of the Dutch-Flemish PROMIS pain interference (PROMIS-PI) and the PROMIS pain behavior (PROMIS-PB) item banks in patients with RA., Methods: A total of 2,029 patients with RA completed the full PROMIS-PI (version 1.1, 40 items), and 1,554 patients completed the full PROMIS-PB (version 1.1, 39 items). The following psychometric properties were studied: unidimensionality, local dependence, monotonicity and graded response model (GRM) fit, cross-cultural validity (differential item functioning [DIF] for language [Dutch versus Flemish]), other forms of measurement invariance, construct validity, reliability, and floor and ceiling effects., Results: The PROMIS-PI and PROMIS-PB banks were sufficiently unidimensional (Omega-hierarchical [Omega-H] 0.99, 0.95, and explained common variance 0.95, 0.78, respectively), had negligible local dependence (0.3-1.4% of item pairs), good monotonicity (H 0.75, 0.46), and a good GRM model fit (no misfitting items). Furthermore, both item banks showed good cross-cultural validity (no DIF for language), measurement invariance (no DIF for age, sex, administration mode, and disease activity), good construct validity (all hypotheses met), high reliability (>0.90 in the range of patients with RA), and an absence of floor and ceiling effects (0% minimum or maximum score, respectively)., Conclusion: Both PROMIS-PI and PROMIS-PB banks showed good psychometric properties in patients with RA and can be used as CATs in research and clinical practice., (© 2019, American College of Rheumatology.)