Search

Background: Foot and ankle problems are frequently prevalent, especially among the elderly, ranging from 70 to 80%. In primary care, foot, and ankle complaints stand out as one of the most frequent reasons for orthopedic consultations. Patient-reported outcome measures are significant in the assessment burden of any condition on the effects of intervention as well as research. The Foot Function Index (FFI) is a region-specific tool that was identified as one of the most commonly used evaluation tools for foot complaints. This study aimed to translate, cross-cultural adapt, and test the psychometric properties of FFI in the Urdu language. Methodology: The FFI was translated into Urdu language (FFI-U) following Beaton et al. translation guidelines. The data were collected from 230 Urdu-speaking participants with different foot and ankle pathologies. Data collection started after the written informed consent from the participants. All participants completed the FFI-U, Visual Analogue Scale (VAS), SF-36, and the Foot and Ankle Outcome Score (FAOS) at baseline while only 30 participants completed ULFI-U after one week for test-retest reliability. The psychometric properties involved reliability and validity testing. Reliability was assessed where internal consistency was measured using Cronbach's alpha and test-retest reliability through the intra-class correlation coefficient (ICC). FFI-U was tested for face validity and construct validity (convergent and discriminant). Psychometric criteria were examined against priori hypotheses, and alpha level (p-value < 0.05) was considered statistically significant. Results: FFI-U demonstrated good reliability with internal consistency (α = 0.86) and test-retest reliability with intra-class correlation coefficient = 0.845 (0.78–0.89). A moderate correlation was found using Pearson correlation between FFI-U total score and physical components of SF-36, VAS (pain, disability), and FAOS (γ= -0.65, 0.72, 0.71, -0.68) respectively, indicating convergent validity however, a weak correlation was found with mental components of SF-36 (γ=-0.25) demonstrating discriminant validity. Face validity was assessed at the pre-final testing stage by interviewing patients. There were no floor and ceiling effects found for FFI-U. Conclusion: The FFI-U has been found reliable, valid, and feasible tool to be used as a patient-reported outcome measure to assess functional levels with different foot and ankle disorders in Urdu speaking population. [ABSTRACT FROM AUTHOR]

Background: Magnetic resonance imaging (MRI) and manual tests remain the standard for diagnosing anterior cruciate ligament (ACL) rupture. Furthermore, the passive knee displacement, also described as anterior tibial translation (ATT), is used in order to make decisions about surgery or to assess rehabilitation outcomes. Unfortunately, these manual tests are limited to passive situations, and their application to assess knee stability in loaded, weight-bearing positions are missing. Therefore, a new device with high-performance sensors and a new sensor setting was developed. The aim of this exploratory cross-sectional study was to assess the test-retest reliability of this new device in a first step and the concurrent validity in a second step. Methods: A total of 20 healthy volunteers were measured. Measurement consistency of the new device was assessed on the basis of reliability during Lachman test setting and in loaded position by artificial knee perturbation in a test-retest procedure. In a second step, the concurrent validity was evaluated with the Lachmeter® as a reference instrument. Intraclass correlation coefficient (ICC), standard error of measurement (SEM), the minimal detectable change (MDC) and Bland-Altman analysis were evaluated to assess the quality criteria. Results: The measurements with the new device during the Lachman test provided a mean ATT of 5.46±2.22mm. The SEM ranged from 0.60 to 0.69mm resulting in an MDC between 1.67 and 1.93mm for the new device. In the loaded test situation, the mean ATT was 2.11±1.20mm, with test-retest reliability also showing good correlation (r>0.83). The comparison of the two measurement methods with an ICC of (r>0.89) showed good correlation, which also underlines the reasonable agreement of the Bland-Altman analysis. Conclusions: The evaluation of the test-retest reliability of the new device during the knee stability testing in passive situation as well as in a functional, loaded situation presented good reliability. In addition, the new device demonstrated good agreement with the reference device and therefore good validity. Furthermore, the quality criteria demonstrated the ability of the new device to detect the cut-off value (3-5mm) described in the literature for the diagnosis of ACL-deficient knees, which underlines the clinical relevance of this new device as a reliable and valid tool. [ABSTRACT FROM AUTHOR]

Background: To date, there are no studies in the literature that define the internal structure of the Tampa Scale for Kinesiophobia (TSK) in patients with chronic neck pain based on factorial analysis. As such, we aimed to verify and identify the best structure of the Brazilian version of the TSK in patients with chronic neck pain. Methods: We included Brazilian participants aged ≥18 years, both sexes, with self-reported neck pain for more than 3 months and pain intensity ≥3 on the Numerical Pain Rating Scale (NPRS). Dimensionality and number of TSK items were assessed using confirmatory factor analysis (CFA). We tested the following internal structures: structure 1 (1 domain and 17 items), structure 2 (1 domain and 11 items), structure 3 (2 domains and 11 items), and structure 4 (2 domains and 9 items). We used the Pain-Related Catastrophizing Thoughts Scale (PCTS) and the NPRS for construct validity. In addition, we assessed test-retest reliability for the seven-day interval using intraclass correlation coefficient (ICC2,1), Cronbach's alpha to assess internal consistency, and ceiling and floor effects. Results: The study sample included of 335 patients. Most were women (77.6%), young adults (~ 34 years), single (48.4%), with complete primary education (57.3%), physically inactive (66.6%), with a mean pain duration of 46 months and a mean pain intensity of ~ 5 points on the NPRS. Redundancy was found in the following items: item 1 with item 2 (modification indices = 21.419) and item 13 with item 15 (modification indices = 13.641). Subsequently, based on these paired analyses, the items with the lowest factor loadings (items 2 and 15) were excluded. As such, TSK structure 4 was composed of two domains ("somatic focus" and "activity avoidance") and 9 items, which showed adequate fit indices and lower AIC and SABIC values. We observed significant values (p < 0.05) with a correlation magnitude greater than 0.142 to 0.657 between the two domains of the TSK-neck and the other instruments (PCTS and NPRS). We found excellent reliability (ICC2,1 ≥ 0.96) and adequate internal consistency (Cronbach's alpha ≥0.98) of the TSK-neck. Finally, ceiling and floor effects were not observed. Conclusion: The TSK-neck structure with two domains (somatic focus and activity avoidance) and nine items is the most appropriate for patients with chronic neck pain. [ABSTRACT FROM AUTHOR]

Background: To translate and cross-culturally adapt the Extended Version of the Nordic Musculoskeletal Questionnaire (NMQ-E) into Persian (NMQ-E-P) and evaluate the psychometric properties in a general population with different occupational tasks across nine body regions. Methods: This cross-sectional study was designed according to the standard guidelines and the COSMIN checklist. The NMQ-E-P was achieved through forward and backward translation methods and consensus to produce the final draft. A Persian-speaking population (n = 571, age 38.24 ± 7.65 years, female = 46.2%) was recruited from industries and office workers with three occupational task inclusion criteria: assembly, office, and lifting. Psychometric properties included validity for face (from confirmed clarity, simplicity, and readability), content (via the content validity index); and construct (through known group validity); additionally, the properties of internal consistency (Cronbach's α); and test-retest reliability (Kappa coefficient of agreement) were considered. Results: No significant issues during the translation process were found. The NMQ-E-P showed adequate internal consistency for all regions (α ≥ 0.87). The test-retest reliability was examined with Kappa agreement correlation coefficient and all items, except ankle regions, showed very good agreements (Kappa coefficient = 0.87-1.0). Excellent ICC values were obtained for quantitative variables (ICC > 0.88) and good construct validity was revealed (p < 0.001). Conclusion: The Persian version of the NMQ-E has very good validity and reliability and can be used by researchers and professionals to evaluate the prevalence of MSDs in nine body regions simultaneously. [ABSTRACT FROM AUTHOR]

Background: The Disability of the Arm, Shoulder and Hand Outcome Measure (DASH) is a validated patient-reported outcome measure (PROM) for many upper extremity musculoskeletal disorders. In patients with severe traumatic conditions, limited evidence exists regarding the equivalence between DASH and its shortened version, QuickDASH, which is more feasible in clinical practice. The rationale of this study was to analyze the concurrent validity of QuickDASH with respect to DASH in patients with traumatic upper extremity amputation. Methods: This study is based on a consecutive cohort of traumatic upper extremity amputation patients treated with replantation or revision (completion) amputation at Tampere University Hospital between 2009 and 2019. We estimated the concurrent validity of QuickDASH with respect to DASH by correlation coefficients, mean score differences, Bland–Altman plots, and distribution density. Additionally, we assessed internal reliability with Cronbach's alpha coefficients and item-total correlations. Results: We found a very strong linear correlation between DASH and QuickDASH scores (r = 0.97 [CI 95% 0.97–0.98], p < 0.001). The mean difference between DASH and QuickDASH was minor (MD = -1, SD 4 [CI95% from -1 to 0] p = 0.02). The mean sub-score for the activity domain was higher for QuickDASH than DASH (MD = -3 [CI95% from -4 to -3] p < 0.000) and lower for the symptom domain (MD = 7 [CI95% from 6 to 9] p < 0.000). The Bland and Altman plot showed good agreement between DASH and QuickDASH scores, but there was measurement error in QuickDASH with high scores (r = -0.20, [CI95% from -0.31 to -0.09], p = 0.001). Conclusion: QuickDASH demonstrates higher total scores than the full DASH and emphasizes rating of activity over symptoms. Still, on average the differences in total scores are likely less than the MCID of DASH, and consequently, this study shows that QuickDASH can be recommended instead of the full DASH when assessing a traumatic condition. Trial registration: Retrospectively registered. [ABSTRACT FROM AUTHOR]

Introduction: Proprioception can be impaired in people with neck pain. The cervical joint position sense test, which measures joint position error (JPE), is the most common test used to assess neck proprioception. The aim of this systematic review was to assess the measurement properties of this test for the assessment of people with and without neck pain. Methods: This systematic review was registered prospectively on Prospero (CRD42020188715). It was designed using the COSMIN guidelines and reported in line with the PRISMA checklist. Two reviewers independently searched Medline, Embase, SportDiscus, and CINAHL Plus databases from inception to the 24th July 2022 with an update of the search conducted until 14th of October 2023. The COSMIN risk of bias checklist was used to assess the risk of bias in each study. The updated criteria for good measurement properties were used to rate individual studies and then the overall pooled results. The level of evidence was rated by two reviewers independently using a modified GRADE approach. Results: Fifteen studies were included in this review, 13 reporting absolute JPE and 2 reporting constant JPE. The measurement properties assessed were reliability, measurement error, and validity. The measurement of JPE showed sufficient reliability and validity, however, the level of evidence was low/very low for both measurement properties, apart from convergent validity of the constant JPE, which was high. Conclusion: The measure of cervical JPE showed sufficient reliability and validity but with low/very low levels of evidence. Further studies are required to investigate the reliability and validity of this test as well as the responsiveness of the measure. [ABSTRACT FROM AUTHOR]

Background: The upper limb functional index (ULFI) is a widely used self-report outcome measure questionnaire with robust psychometric properties to assess the upper limb musculoskeletal disorders (UL-MSDs). This study aimed to investigate the psychometric properties of the Arabic version of ULFI (ULFI-Ar). Methods: In this observational study, 139 patients (87 male, 52 females with mean age of 38.67 ± 13.04 year) with various UL-MSD's, completed the ULFI-Ar, Disability of Arm, Shoulder, and Hand questionnaire (DASH-Arabic), and numeric pain rating scale (NPRS-Arabic). All participants determined the factor structure, and the construct validity. A subgroup of the participants determined test–retest reliability (n = 46) and responsiveness (n = 27). Results: The ULFI-Ar construct validity obtained by the expletory factor analysis as one-factor structure, demonstrated an excellent test–retest reliability [intraclass correlation coefficient (ICC2:1) = 0.95], measurement error [standard error of measurement (SEM) = 4.43%; minimal detectable change at 90% confidence interval (MDC90) = 10.34%], medium internal responsiveness [Cohen's d = 0.62 and standard response of mean (SRM) = 0.67], strong external responsiveness DASH-Arabic (r =—0.90; p < 0.001), and negative strong correlation with NPRS-Arabic (r =—0.75, p < 0.001). Conclusions: The ULFI-Ar is a valid, reliable, and responsive self-report questionnaire to assess UL-MSDs in Arabic speaking patients. [ABSTRACT FROM AUTHOR]

Background: Musculoskeletal disorders (MSDs) are a common reason for seeking primary health care. The STarT Musculoskeletal (MSK) tool is designed to stratify patients suffering from MSDs to risk groups, based on prognostic factors. Aim: The aim was to translate and cross-culturally adapt the STarT MSK tool in a Swedish primary health care context through testing of reliability and construct validity. Methods: We included consecutive patients with MSDs seeking primary care (n = 99). The STarT MSK was translated using international recommendations. Construct validity was investigated by correlation analysis (Spearmans Rho) with the following reference instruments: the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ), the EuroQol 5-dimension (EQ-5D) and the Musculoskeletal Health Questionnaire (MSKHQ). Reliability was tested using test–retest (Intra Class Correlation, ICC2.1) (n = 31). Known-groups validity was calculated with a difference of 10% between risk groups based on how the participants had answered. Results: The STarT MSK was successfully translated into Swedish. The participants were grouped into low risk (n = 28), medium risk (n = 60) and high risk (n = 11). The construct validity showed a moderate to high correlation with the ÖMPQ (r =.61), EQ-5D (r =.59) and MSK-HQ (r =.56). All separate items except item 2 and 9 correlated according to predefined hypotheses. Test–retest demonstrated an excellent reliability for the total score (ICC2.1 0.85) (n = 31). The STarT MSK tool was able to differentiate by 10% between the risk groups, based on how the participants had answered. Conclusion: The STarT MSK has been successfully translated and adapted into Swedish and shows acceptable measurement properties regarding test–retest reliability and aspects of validity and seems to be able to discriminate between the proposed risk groups. The tool can therefore be useful in a Swedish primary health care context. A future study needs to determine the tools predictive validity and to investigate if stratification to risk groups leads to a faster recovery and to lower health care costs. [ABSTRACT FROM AUTHOR]

Background: Precise causes of musculoskeletal complaints among nurses are not known well, but many studies have pointed to manual patient handling tasks. Subjective judgment and decision-making process for patient lifting is crucial for gathering data regards patient handling. The aim of this study was to consider reliability and validity and re-structure of two special tools for patient handling's tasks. Methods: In this cross- sectional study 249 nurses were fully participated. As recommended by literature for cultural adaptation of instruments, forward/backward translation method was applied. Reliability of the translated version was assessed by Cronbach's alpha coefficient. Validity testing for the two scales was based on content validity index/ratio analysis and also Exploratory Factor Analysis was run to extract latent factors. Results: Reliability estimated by internal consistency reached a Cronbach's Alpha of above 0.7 for all subscales of two questionnaires. After testing the validity, the final version of questionnaires was remained by 14 and 15 questions respectively. Conclusions: These instruments evaluated for manual handling of normal and obese patients had acceptable validity and reliability in Iranian Nursing context. So, these tools can be used in further studies with the same cultures. [ABSTRACT FROM AUTHOR]

Objective: To translate and culturally adapt the Profile Fitness Mapping neck questionnaire (ProFitMap-neck) into the Chinese version and evaluate its psychometric properties. Methods: The procedure of translation and cross-cultural adaptation was performed according to the recommended guidelines. A total of 220 patients with chronic neck pain (CNP) and 100 individuals without neck pain participated in the study. Internal consistency, test-retest reliability, content validity and construct validity were investigated. Results: The Chinese version of ProFitMap-neck (CHN-ProFitMap-neck) showed adequate internal consistency (Cronbach's α = 0.88–0.95). A good test-retest reliability was proven by the intraclass correlation coefficient (ICC3A,1 = 0.78–0.86). Floor-ceiling effects were absent. Exploratory factor analysis revealed 6 factors for the symptom scale and 4 factors for the function scale. The CHN-ProFitMap-neck showed a moderate to high negative correlation with NDI (r = 0.46–0.60, P < 0.01), a small to moderate negative correlation with VAS (r = 0.29–0.36, P < 0.01), and a small to high positive correlation with SF-36 (r = 0.21–0.52, P < 0.01). No significant correlation between the CHN-ProFitMap-neck function scale and VAS (P > 0.05) or the mental health domain of the SF-36 was found (P > 0.05). The CHN-ProFitMap-neck scores were significantly lower in the CNP group than in the non-CNP group (P < 0.01). Conclusions: The CHN-ProFitMap-neck had acceptable psychometric properties and could be used as a reliable and valid instrument in the assessment of patients with chronic neck pain in mainland China. [ABSTRACT FROM AUTHOR]

Background: Functional tests are important clinical tools, since they are non-invasive methods, with simple applicability, and low cost. However, there are few tests adapted for individuals with chronic low back pain. Thus, our objective was to evaluate the test-retest and inter-rater reliability of the 2-Minute Step Test in individuals with chronic low back pain and to correlate the test score with measures of pain and physical activity.Methods: We included patients aged between 18 and 45 years, of both sexes, and with low back pain. The interval between the test and retest was 7 days. We analyzed the data via intra-class correlation coefficient (ICC), confidence interval at 95%, standard error of measurement, and minimum detectable change for reliability. We used the Spearman's correlation coefficient to verify the correlation between 2-Minute Step Test and measures of pain and physical activity (Numerical Pain Scale, Roland-Morris Disability Questionnaire, Pain-Related Catastrophizing Thoughts Scale, Tampa Scale of Kinesiophobia, and Baecke Habitual Physical Activity Questionnaire).Results: Sample is composed of 37 individuals, most of them female, with overweight and low back pain > 60 months. 2-Minute Step Test showed excellent test-retest (ICC = 0.903) and inter-rater (ICC = 0.925) reliability. Sport domain of the Baecke showed a significant correlation with the 2-Minute Step Test (rho = 0.444).Conclusion: 2-Minute Step Test is a reliable measure to measure the functional capacity of patients with chronic low back pain considering different times and examiners, as well as being positively correlated with sports practice. [ABSTRACT FROM AUTHOR]

Objective: To validate and evaluate the intra- and inter-rater reliability of the 2-min step test (2MST) in measuring the functional performance of patients with knee pain associated with osteoarthritis (OA).Methods: Forty-one patients with knee OA was included. Two examiners assessed the patients at two times with interval between the test and retest from 7 to 14 days. All executions of 2MST were recorded in real time by the examiners and were also recorded by video. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI), standard error of measurement (SEM) and minimum detectable difference (MDD) were used to determine reliability. In the construct validity, we correlate the score of the 2MST with the other instruments used in the study: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numerical Pain Scale (NPS), Pain-Related Catastrophizing Thoughts Scale (PCTS) and Chronic Pain Self-Efficacy Scale (PSEQ). The agreement between the face-to-face assessment and the evaluation based on the video record was assessed using the Bland-Altman methodology in the 4 moments of the 2MST.Results: 2MST presented excellent intra- (ICC = 0.94, SEM = 4.47, MDD = 12.40) and inter-rater reliability (ICC = 0.97, SEM = 3.07, MDD = 8.52). The agreement was acceptable between face-to-face assessments and the analyzes performed on video. All instruments showed a statistically significant correlation with 2MST, except the PCTS. A correlation magnitude above 0.50 was found between the 2MST and pain and function domains of the WOMAC, and a correlation magnitude between 0.30 and 0.50 with the joint stiffness domain of the WOMAC, NRPS and PSEQ.Conclusion: 2MST proved to be valid for assessing functional capacity in patients with knee OA, with excellent reliability. [ABSTRACT FROM AUTHOR]

Background: The straight leg raise test (SLR) is one of the most utilized and studied physical tests in patients with low back pain (LBP) for the detection of lumbar disc herniation (LDH), showing high sensitivity and heterogeneous or low specificity. The high incidence of asymptomatic 'pathologic' findings in the magnetic resonance imaging (MRI) scans may cause verification bias to these results. We studied an extended SLR (ESLR) by adding location-specific structural differentiation movements (hip internal rotation or ankle dorsiflexion) to the traditional SLR for it to better differentiate neural symptoms from musculoskeletal. Previously, the ESLR has shown almost perfect interrater reliability between examiners and ability to detect sciatic patients. In this study, we investigated whether a 'positive' ESLR finding is associated with pathology seen on MRI.Methods: Forty subjects comprised the study population, 20 in sciatic group and 20 in control group. The ESLR was performed 'blinded' to the subjects. After the ESLR, each subject's lumbar MRI was evaluated. The MRIs were analyzed independently by 2 senior radiologists and a spine specialist clinician. The ESLR and MRI results were cross-tabulated. To obtain the odds ratio (OR) with positive ESLR or SLR results for LDH or nerve root compression (NC), a binary logistic regression analysis with subjects' age, gender, height and weight was performed. ESLR's validity was assessed by combination of interrater agreement and percentage prevalence of both LDH and NC.Results: Of sciatic (ESLR+) patients, 85 % had LDH and 75 % NC in the MRI. Not surprisingly, MRI showed a very high incidence of 'false-positive' findings with the ESLR negative group. The ESLR showed 0.85 sensitivity and 0.45 specificity for LDH and 0.75 sensitivity and 0.50 specificity for NC. A positive result in the ESLR was found to be strongly associated with for both LDH and NC: the OR was 8.0 (p = 0.028) and 5.6 (p = 0.041), respectively.Conclusions: The ESLR shows high validity in detecting neural symptoms and is strongly associated with pathology seen in the MRI when judged positive. We suggest the use of ESLR in clinical practice as a part of clinical examination, where it may prove to be a valuable tool in detecting patients with sciatic symptoms. [ABSTRACT FROM AUTHOR]

Background: Patients undergoing total knee arthroplasty (TKA) tend to be younger and tend to receive TKA at an earlier stage compared to 20 years ago. The Oxford Knee Score - Activity and Participation (OKS-APQ) questionnaire evaluates higher levels of activity and participation, reflecting activity patterns of younger or more active people. The purpose of this study was to translate the OKS-APQ questionnaire into Dutch, and to evaluate its measurement properties in pre- and postoperative TKA patients.Methods: The OKS-APQ was translated and adapted according to the forward-backward translation multi step approach and tested for clinimetric quality. Floor and ceiling effects, structural validity, construct validity, internal consistency and test-retest reliability were evaluated using COSMIN quality criteria. The OKS-APQ, the Oxford Knee Score (OKS), the Short Form-36 (SF-36), a Visual Analogue Scale (VAS) for pain and the Forgotten Joint Score (FJS) were assessed in 131 patients (72 preoperative and 59 postoperative TKA patients), and the OKS-APQ was administered twice in 50 patients (12 preoperative and 38 postoperative TKA patients), after an interval of minimal 2 weeks.Results: Floor effects were observed in preoperative patients. Confirmatory factor analyses (CFA) indicated a good fit of a 1-factor model by the following indices: (Comparative Fit Index (CFI): 0.97, Tucker-Lewis Index (TLI): 0.96 and Standardized Root Mean Square Residual (SRMR): 0.03). Construct validity was supported as > 75% of the hypotheses were confirmed. Internal consistency (Cronbach α's from 0.81 to 0.95) was good in the pooled and separate pre- and postoperative samples and test-retest reliability (Intraclass Correlation Coefficients (ICCs) from 0.63 - 0.85) were good in postoperative patients and moderate in preoperative patients. The standard Error of Measurements (SEMs) ranged from 8.5 - 12.2 and the Smallest Detectable Changes in individuals (SDCind) ranged from 23.5 - 34.0 (on a scale from 0 to 100).Conclusions: Preliminary findings suggest that the Dutch version of the OKS-APQ is reliable and valid for a Dutch postoperative TKA patient sample. However, in a preoperative TKA sample, the OKS-APQ seems less suitable, because of floor effects and lower test-retest reliability. The Dutch version of the OKS-APQ can be used alongside the OKS to discriminate among levels of activity and participation in postoperative patients. [ABSTRACT FROM AUTHOR]

Background: We recently developed a model of stratified exercise therapy, consisting of (i) a stratification algorithm allocating patients with knee osteoarthritis (OA) into one of the three subgroups ('high muscle strength subgroup' representing a post-traumatic phenotype, 'low muscle strength subgroup' representing an age-induced phenotype, and 'obesity subgroup' representing a metabolic phenotype) and (ii) subgroup-specific exercise therapy. In the present study, we aimed to test the construct validity of this algorithm.Methods: Data from five studies (four exercise therapy trial cohorts and one cross-sectional cohort) were used to test the construct validity of our algorithm by 63 a priori formulated hypotheses regarding three research questions: (i) are the proportions of patients in each subgroup similar across cohorts? (15 hypotheses); (ii) are the characteristics of each of the subgroups in line with their proposed underlying phenotypes? (30 hypotheses); (iii) are the effects of usual exercise therapy in the 3 subgroups in line with the proposed effect sizes? (18 hypotheses).Results: Baseline data from a total of 1211 patients with knee OA were analyzed for the first and second research question, and follow-up data from 584 patients who were part of an exercise therapy arm within a trial for the third research question. In total, the vast majority (73%) of the hypotheses were confirmed. Regarding our first research question, we found similar proportions in each of the three subgroups across cohorts, especially for three cohorts. Regarding our second research question, subgroup characteristics were almost completely in line with the proposed underlying phenotypes. Regarding our third research question, usual exercise therapy resulted in similar, medium to large effect sizes for knee pain and physical function for all three subgroups.Conclusion: We found mixed results regarding the construct validity of our stratification algorithm. On the one hand, it is a valid instrument to consistently allocate patients into subgroups that aligned our hypotheses. On the other hand, in contrast to our hypotheses, subgroups did not differ substantially in effects of usual exercise therapy. An ongoing trial will assess whether this algorithm accompanied by subgroup-specific exercise therapy improves clinical and economic outcomes. [ABSTRACT FROM AUTHOR]

Background: Knee injury and osteoarthritis outcome score questionnaire is a widely used tool for measuring short and long-term patient-relevant outcomes following knee injury. KOOS is neither translated nor examined for psychometric properties before. Therefore, the aim of this study was to translate, culturally adapt and check the psychometric properties of the KOOS in Urdu.Methodology: The translation and cultural adaptation was performed according to pre-defined guidelines. A total of 117 participants (54 males and 63 females) were recruited. The study had two steps: 1) Translation and cultural adaptation 2) Reliability and validity testing. The reliability (test-retest and internal consistency at (95% confidence interval) as well as the validity (Convergent validity) of final Urdu version of KOOS was tested.Results: For all five domains, the KOOS Urdu version (KOOS-U) has demonstrated high test-retest reliability ICC = 0.90-0.96(CI = 95%). For all domains, the internal consistency was determined to be excellent (α = 0.82-0.96). There were no floor or ceiling impacts noted. Convergent validity was found to be good, as measured by Pearson's correlation coefficient. The findings revealed a strong negative association between the KOOS-U (QOL and pain) and the NPRS. And there was a low to high positive correlation between five KOOS-U domains and all SF-12 domains, i.e., there was a significant positive correlation between the pain domains of both KOOS and SF-12 with the r = 0.87(p < 0.05).Conclusion: The Urdu version of KOOS is a valid, reliable, and responsive instrument to assess functional disability of patients with Knee Osteoarthritis with excellent psychometric properties. [ABSTRACT FROM AUTHOR]

Background: Limitations in spinal mobility are a characteristic feature of Axial Spondyloarthritis. Current clinical measurements of spinal mobility have shown low criterion-concurrent validity. This study sought to evaluate criterion-concurrent validity for a clinically feasible measurement method of measuring spine mobility using tri-axial accelerometers.Methods: Fifteen radiographic-Spondyloarthritis patients were recruited for this study. Two postural reference radiographs, followed by three trials in forward, left and right lateral bending were taken. For all trials, three measurements were collected: tape (Original Schober's, Modified Schober's, Modified-Modified Schober's, Lateral Spinal Flexion Test and Domjan Test), followed immediately by synchronized radiograph and accelerometer measurements at end range of forward and bilateral lateral flexion. The criterion-concurrent validity of all measurement methods was compared to the radiographic measures using Pearson's correlation coefficients. A Bland-Altman analysis was conducted to assess agreement.Results: In forward bending, the accelerometer method (r = 0.590, p = 0.010) had a stronger correlation to the radiographic measures than all tape measures. In lateral bending, the Lateral Spinal Flexion tape measure (r = 0.743, p = 0.001) correlated stronger than the accelerometer method (r = 0.556, p = 0.016). The Domjan test of bilateral bending (r = 0.708, p = 0.002) had a stronger correlation to the radiographic measure than the accelerometer method.Conclusions: Accelerometer measures demonstrated superior criterion-concurrent validity compared to current tape measures of spinal mobility in forward bending. While a moderate correlation exists between accelerometer and radiographs in lateral bending, the Lateral Spinal Flexion Test and Domjan Test were found to have the best criterion-concurrent validity of all tests examined in this study. [ABSTRACT FROM AUTHOR]

Background: Health-care workers have an increased risk for chronic low back pain (LBP) leading to reduced workability. Depression, a highly prevalent, costly and disabling condition, is commonly seen in patients with sub-acute LBP. This study investigated the psychometric properties and construct-validity of a modified 9-item Patient Health Questionnaire (PHQ-9-mFIN) in female health-care workers with sub-acute LBP.Methods: Reliability (internal consistency, test-retest repeatability) was assessed using standard methods. Construct validity of the PHQ-9-mFIN was assessed as level of depressive symptoms (PHQ-9-mFIN: 0-4 none, 5-9 mild, ≥10 at least moderate) against the RAND 36 Health Survey, a valid measure of health-related quality of life (HRQoL). Additionally, the strength of the association between the levels of PHQ-9-mFIN and selected biopsychosocial factors was determined.Results: The internal consistency of the PHQ-9-mFIN was high (Cronbach's α = 0.82) and the test-retest repeatability scores (n = 64) were moderate: Pearson's correlation was 0.73 and Intraclass Correlation Coefficient (ICC) 0.73 (95% CI: 0.58 to 0.82). Construct validity (Spearman correlation) against the Physical and Mental component items and their summary scales of the RAND 36 were much higher for the Mental (range, - 0.40 to - 0.67 and - 0.64) than for the Physical (range, - 0.08 to - 0.43 and - 0.22). There was a clear stepwise association (p < 0.001) between the levels of depressive symptoms and General health (physical component, range, 59.1 to 78.8). The associations with all items of the Mental components were strong and graded (p < 0.001). All participants had low scores for Bodily pain, regardless of the level of depressive symptoms. There was a strong association (p ≤ 0.003) between the levels of PHQ-9-mFIN and multisite pain, lumbar exertion and recovery after workdays, neuromuscular fitness in modified push-ups, workability, and fear of pain related to work.Conclusions: The PHQ-9-mFIN showed adequate reliability and excellent construct validity among female health-care workers with recurrent LBP and physically strenuous work.Trial Registration: NCT01465698 . [ABSTRACT FROM AUTHOR]

Background: Headache is a common and costly health problem. Although the pathogenesis of headache is heterogeneous, reported contributing factors are dysfunctions of the upper cervical spine. The flexion rotation test (FRT) is a commonly used diagnostic test to detect upper cervical movement impairment. A digital goniometer may support precise measurement of movement impairment in the upper cervical spine. However, its reliability and validity is not assessed, yet. The aim of this study was to investigate the reliability and validity of the digital goniometer compared to an ultrasound-based movement analysis system.Methods: Two separate cross-sectional studies were conducted using the digital goniometer EasyAngle (Meloq AB, Stockholm, Sweden) for a) investigating the concurrent validity of upper cervical range of motion (ROM) during the FRT and b) determining the inter- and intra-rater reliability in the target population of patients with head and neck pain. Sixty-two participants, 39 with and 23 without head and neck pain, were recruited for the concurrent validity study. For the reliability study, a total of 50 participants were recruited. Intraclass correlation coefficients (ICC) and Bland Altmann plots were used to assess validity and ICC values, Bland Altmann plots as well as Kappa coefficients were used for estimating intra-rater and inter-rater reliability.Results: Concurrent validity was strong with an ICC (2,1) of 0.97 for ROM to either side (95%CI = 0.95-0.98). Bland Altman Plots revealed a mean difference between measurement systems of 0.5° for the left and 0.11° for the right side. The inter-rater ICC (2,1) was 0.66 (95%CI 0.47-0.79, p <  0.001, SEM 6.6°), indicating good reliability. The limits of agreement were between 10.25° and - 11.89°, the mean difference between both raters was - 0.82°. Intra-rater reliability for the measurement of ROM during the FRT was between 0.96 (ICC 3,1) for rater 1 and 0.94 (ICC 3,1) for rater 2.Conclusions: The digital goniometer demonstrated strong concurrent validity and good to strong reliability and can be used in clinical practice to accurately determine movement impairment in the upper cervical spine.Trial Registration: German Registry of Clinical Trials DRKS00013051 . [ABSTRACT FROM AUTHOR]

Background: Hand rehabilitation needs valid evaluation tools; the 400-point Hand Assessment (HA) is an exhaustive but not standardised tool. The aim of this study was to validate a standardised version of this test.Methods: A modified version and a standardised prototype was made for this prospective validation study (four centres, three countries). Psychometric properties studied: reliability (intra-rater and inter-rater, standard error of measurement [SEM], minimum detectable change [MDC],internal consistency); content validity, construct validity with Jebsen Taylor hand function test, QuickDASH, MOS-SF 36 and pain; responsiveness, using an anchor-based approach (ROC curve with area under curve, mean response change) with calculation of MCID. For SEM, MDC and responsiveness, QuickDASH was used for comparison.Results: One hundred and seventy-six patients with hand/wrist injuries were included between May 2013 and February 2015. One hundred and seventy were available for final analysis: 67% men; mean age 43.4 ± 13.2 years; both manual and office workers (46, 5% of each); 37% had a hand or wrist fracture. Reliability: ICC intra-rater = 0.967 [0.938-0.982]; inter-rater = 0.868 [0.754-0.932]. Distribution-based approach: for 400-point HA/QuickDASH: SEM = 3.48/4.52, MDC = 9.065/12.53, internal consistency of 400-point HA: Cronbach α = 0.886.Validity: Content validity was good according to COSMIN guidelines. Construct validity: correlation coefficient: Jebsen-Taylor hand function test = - 0.573 [- 0.666-0.464], QuickDASH = - 0.432 at T0 [- 0.545-0.303], - 0.551 at T3 [- 0.648-0.436]; MOS-SF 36 physical component = 0.395 [0.263-0.513]; no correlation with MOS-SF 36 mental component = 0.142 [- 0.009 + 0.286] and pain = - 0.166 [- 0.306 + 0.018]. Responsiveness: Anchor-based approach: AUC Δ400-point HA = 0.666 [0.583-0.749], AUC ΔQuickDASH = 0.556 [0.466-0.646]. MCID (optimal ROC curve cut-off): 6.07 for 400-point HA, - 2.27 for QuickDASH. MCID with mean response change + 12.034 ± 9.067 for 400-point HA and - 8.03 ± -9.7 for QuickDASH. The patient's global impression of change was only correlated with the Δ400-point HA.Conclusions: The 400-point HA standardised version has good psychometric properties. For responsiveness, we propose an MCID of at least 12.3/100. However, these results must be confirmed in other populations and pathologies.Trial Registration: This study was retrospectively registered into ISCTRN registry (Number ISRCTN25874481) the 07/02/2019. [ABSTRACT FROM AUTHOR]

Background: No quality of life (QoL) questionnaire exists for patients with scapula alata (SA). The objective of this study was to develop and validate a QoL questionnaire for SA patients.Methods: A team consisting of experts (n = 7) and SA patients (n = 7) developed, through five continuous phases, a QoL questionnaire for SA patients (SA-Q). The developed questionnaire consists of 21 items, grouped in five domains: physical symptoms (five items), work (four items), sport and leisure activities (four items), life style (four items) and emotions (four items). Content and face validity for the SA-Q questionnaire were evaluated by a sample of 48 (90%) out of 53 SA patients recruited from a university hospital. The Content Validity Index (CVI) and modified kappa index (κ*) assessed the relevance of SA-Q questionnaire.Results: The SA patients evaluated 20 (95%) out of 21 items as excellent for content validity (I-CVI > 0.78, κ* > 0.74), one (5%) item was considered as good (I-CVI < 0.78, 0.60 < κ* < 0.74). The average scale (S-CVI/ave) for the entire SA-Q questionnaire was 0.93 indicating an excellent content validity.Conclusions: This study presents the development and validation of content validity of the first QoL questionnaire for SA patients. The SA-Q questionnaire has potential clinical implications for detected changes concerning the different items during rehabilitation.Clinical Trials: Not relevant. [ABSTRACT FROM AUTHOR]

Background: To conduct a cross-cultural adaptation and validation of the Core Outcome Measures Index (COMI) in the Slovenian language, for use in patients with low back pain.Methods: The English version of COMI was translated into Slovene following established guidelines. Three hundred fifty-three patients with chronic low back pain were recruited from the Orthopedic clinic department of a tertiary care teaching institution. Data quality, construct validity, responsiveness, and test-retest reliability of the COMI were assessed.Results: The questionnaire was generally well accepted with no missing values. The majority of items exhibited only mild ceiling effects (below 20.0%) and somewhat more prominent floor effects, which were similar to previous studies (4.5-78.8%). Correlations with Oswestry Disability Index (ODI) were high (ρ = 0.76 between overall COMI and ODI scores), suggesting that the Slovene version of COMI had high construct validity. Additionally, the Slovene version of COMI successfully captured surgical patients' improvement in their low back problem after surgery (overall COMI score change: Z = - 9.34, p < .001, r = - 0.53) and showed acceptable test-retest reliability (ICC = 0.86).Conclusions: The Slovene version of COMI showed good psychometric properties, comparable to those of previously tested language versions. It represents a valuable instrument for the use in future domestic and multicenter clinical studies. [ABSTRACT FROM AUTHOR]

Background: There is no physiotherapy-specific quality indicator tool available to evaluate physiotherapy care for people with hip and/or knee osteoarthritis (OA). This study aimed to develop a patient-reported quality indicator tool (QUIPA) for physiotherapy management of hip and knee OA and to assess its reliability and validity.Methods: To develop the QUIPA tool, quality indicators were initially developed based on clinical guideline recommendations most relevant to physiotherapy practice and those of an existing generic OA quality indicator tool. Draft items were then further refined using patient focus groups. Test-retest reliability, construct validity (hypothesis testing) and criterion validity were then evaluated. Sixty-five people with hip and/or knee OA attended a single physiotherapy consultation and completed the QUIPA tool one, twelve- and thirteen-weeks after. Physiotherapists (n = 9) completed the tool post-consultation. Patient test-retest reliability was assessed between weeks twelve and thirteen. Construct validity was assessed with three predefined hypotheses and criterion validity was based on agreement between physiotherapists and participants at week one.Results: A draft list of 23 clinical guideline recommendations most relevant to physiotherapy was developed. Following feedback from three patient focus groups, the final QUIPA tool contained 18 items (three subscales) expressed in lay language. The test-retest reliability estimates (Cohen's Kappa) for single items ranged from 0.30-0.83 with observed agreement of 64-94%. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI) for the Assessment and Management Planning subscale was 0.70 (0.54, 0.81), Core Recommended Treatments subscale was 0.84 (0.75, 0.90), Adjunctive Treatments subscale was 0.70 (0.39, 0.87) and for the total QUIPA score was 0.80 (0.69, 0.88). All predefined hypotheses regarding construct validity were confirmed. However, agreement between physiotherapists and participants for single items showed large measurement error (Cohen's Kappa estimates ranged from - 0.04-0.59) with the ICC (95% CI) for the total score being 0.11 (- 0.14, 0.34).Conclusions: The QUIPA tool showed acceptable test-retest reliability for subscales and total score but inadequate reliability for individual items. Construct validity was confirmed but criterion validity for individual items, subscales and the total score was inadequate. Further research is needed to refine the QUIPA tool to improve its clinimetric properties before implementation. [ABSTRACT FROM AUTHOR]

Background: The Western Ontario Meniscal Evaluation Tool (WOMET) is the only questionnaire available to assess quality of life in patients with isolated meniscal injuries. The aims of this study were to prepare the Persian version of the WOMET (PWOMET) and validate it in Iranian patients with isolated meniscal tears.Methods: In the first stage, the English version of WOMET was translated into Persian. Content validity, and qualitative and quantitative (impact score) face validity were tested by specialists and in a sample of 30 patients. In the second stage, PWOMET was assessed for the evaluation of psychometric properties in 100 patients with isolated meniscal injury and 50 healthy people based on the COSMIN checklist. Construct validity was tested based on structural validity (factor analysis) and hypothesis testing. Correlation with the total scores on the SF-36, IKDC and KOOS were used for concurrent criterion validity. Test-retest reliability and internal consistency were calculated using intraclass correlation coefficient (ICC) and Cronbach's alpha, respectively. In addition the standard error of measurement (SEM) and smallest detectable change were calculated. Interpretability was investigated as the ceiling and floor effects and minimal important difference.Results: The PWOMET had acceptable qualitative face validity and content validity. The impact score (quantitative face validity) was more than 1.5 for all items. For construct validity, structural validity (factor analysis) and hypothesis testing ability were confirmed. Correlations between the PWOMET total score and IKDC, SF-36, KOOS scores were 0.61, 0.54 and 0.63, respectively (p < 0.001), thus confirming concurrent criterion validity. The intraclass correlation coefficient, Cronbach's alpha, SEM and smallest detectable change for the PWOMET were 0.73, 0.89, 9.43 and 26.13, respectively. The PWOMET had no ceiling or floor effects, and minimal important difference was 9.07.Conclusion: The PWOMET provides valid and reliable scores for assessment of the quality of life in patients with isolated meniscal injury. [ABSTRACT FROM AUTHOR]

Background: The conventional way to identify generalised joint hypermobility is by a physical examination according to the Beighton Score. However, a physical examination is time-consuming in clinical practise and may be unfeasible in population-based studies. The self-assessment five-part questionnaire on hypermobility (5PQ) offers a more practicable way to identify GJH. The aim of this study was to test validity and reliability of the five-part questionnaire on hypermobility (5PQ) translated into Swedish on a non-clinical adult population.Methods: A structured procedure was used for the translation of the 5PQ into Swedish. The Beighton Score was used as reference standard for generalised joint hypermobility. Test-retest reliability was tested in a separate group who filled in the questionnaire twice with a ten-week interval. Participants consisted of a convenience sample recruited in Stockholm, Sweden (2017).Results: A total of 328 participants were included in the study, 297 participants in the validity group and 31 participants in the reliability group. When evaluated against a present Beighton Score with an age-dependent cut-off, the Swedish 5PQ attained a sensitivity of 91%, a specificity of 75% and an area under the curve of 0.87. The Swedish 5PQ showed substantial to almost perfect test-retest reliability.Conclusions: The Swedish 5PQ is a valid and reliable instrument to screen for or to identify generalised joint hypermobility. [ABSTRACT FROM AUTHOR]

Background: Intramuscular fat infiltration is a critical factor in surgical decision-making and is the most important factor used to prognosticate surgical repair outcomes in patients with rotator cuff tears. Quantitative 3D assessment of total rotator cuff fat infiltration in patients with rotator cuff tears has been realized. However, a reproducible method to evaluate 3D spatial distribution of rotator cuff intramuscular fat has not been established. The objective of this study was to establish the reproducibility, change detectable beyond error, and concurrent validity of a semi-automated method to evaluate the 3D spatial distribution of fat infiltration and muscle volume in patients with rotator cuff tears.Methods: Thirteen consecutive patients diagnosed with symptomatic rotator cuff pathology and 3.0 T MRI confirmation at a single center were included. Fat-water imaging was used to quantify 3D intramuscular fat (%fat) in sagittal oblique sequences and intramuscular spatial distribution with the semi-automated technique. Each rotator cuff muscle was manually segmented yielding %fat in four axial intramuscular quartile-regions (superior-inferior; Q1-4) and three sagittal (medial/ intermediate/ lateral) regions. Reliability and concurrent validity of %fat and whole muscle volume were calculated with intraclass correlation coefficients (ICC).Results: Intra-rater reliability for intramuscular sagittal divisions (ICC = 0.93-0.99) and axial divisions (ICC = 0.78-0.99) was good/excellent. Inter-rater reliability for %fat (ICC = 0.82-0.99) and volume (ICC = 0.92-0.99) was good/excellent. Concurrent validity with commercialized software showed good/excellent agreement (ICC = 0.66-0.99).Conclusions: A new semi-automated method to assess 3-dimensional intramuscular distribution of fat infiltration in patients with rotator cuff tears using advanced MR imaging demonstrates high intra and inter-rater reliability and good concurrent validity. Minimal detectable change thresholds established facilitate clinical interpretation for future clinical application of this technique to assess change and treatment efficacy in patients with rotator cuff tears. [ABSTRACT FROM AUTHOR]

Background: The Pedi International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) child are validated questionnaires for children with knee disorders. The aim of this study was to translate these questionnaires in Dutch and to recommend which questionnaires should - based on their psychometric properties - be used in clinical practice.Methods: The English Pedi-IKDC and KOOS-Child were translated by the forward-backward procedure. Subsequently, content validity of the Pedi-IKDC and KOOS-Child was evaluated by both patients (n = 18) and experts (n = 18). To evaluate construct validity and interpretability participants with knee disorders (n = 100) completed the Numeric Rating Scale Pain, Lysholm Knee Scoring Scale, EuroQol-5 Dimension, Pedi-IKDC and KOOS-Child at baseline. Participants completed the anchor question, Pedi-IKDC and KOOS-child two weeks (n = 54) and one year (n = 71) after baseline, for evaluating the test-retest reliability and responsiveness. Psychometric properties were interpreted following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria.Results: The Pedi-IKDC showed adequate test-retest reliability (intraclass correlation coefficient (ICC) 0.9; standard error of measurement (SEM) 8.6; smallest detectable change (SDC) 23.8), adequate content validity (> 75% relevant), adequate construct validity (75% confirmed hypotheses), low floor or ceiling effects (scores between 5 and 95) and adequate responsiveness (> 75% confirmed hypotheses). The KOOS-Child showed an adequate test-retest reliability (ICC 0.8-0.9; SEM 8.9-16.9; SDC 24.7-46.9), adequate content validity (> 75% relevant, except KOOS-Child subscale ADL), adequate construct validity (75% confirmed hypotheses), low floor and ceiling effects (scores between 5 and 95, except KOOS-Child subscale activities of daily living and Sport/play) and moderate responsiveness (40% confirmed hypotheses).Conclusions: The Pedi IKDC showed better psychometric properties than the KOOS-Child and should therefore be used in children with knee disorders. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) of the hip is a disease that entails a major burden for patients and the society as a whole. One way of measuring this burden for the patient is through impact on Health-related Quality of Life (HRQL). The Oxford Hip Score (OHS) is a well-known tool to measure HRQL in patients with OA of the hip. This study aims to assess the psychometric properties of the Spanish-adapted version of the OHS, including its reliability, validity, and sensitivity to change.Methods: Prospective observational study that included 361 patients diagnosed with hip OA (according to the criterion of the American College of Rheumatology) from 3 different Spanish regions. Their HRQL was assessed using a generic questionnaire, the EQ-5D-5 L, and two specific ones (the Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC, and the OHS) adapted to Spanish. There was a follow-up period of 6 months, and the acceptability, psychometric properties, presence of ceiling and floor effects, validity, reliability, and sensitivity to changes of the OHS were measured.Results: The OHS was fully answered in 99.4% of cases with no indication of ceiling or floor effects. Its factor structure can be explained in a single dimension. Its discriminative capacity was very good compared to the groups generated by the WOMAC and the EQ-5D-5 L. The correlation between the OHS and dimensions of the WOMAC or EQ-5D-5 L utilities was ≥0.7. Excellent test-retest reliability (ICC = 0.992; CI95%: 0.994-0.998) and internal consistency (Cronbach's α = 0.928) were observed. The minimal clinically important difference (MCID) was 7.0 points, and the minimum detectable change (MDC) was 5.5 points. The effect size for moderate improvement in perceived HRQL was 0.73, similar to that of WOMAC dimensions and higher than the EQ-5D-5 L.Conclusions: The Spanish-adapted version of the OHS is a useful, acceptable tool for the assessment of perceived HRQL in patients with hip OA, and has psychometric properties similar to those of the WOMAC that allow for discriminating both a patient's condition at a given moment and changes that can occur over time. [ABSTRACT FROM AUTHOR]

Background: Fibromyalgia (FM), a disorder characterized by chronic widespread pain and tenderness, affects greater than five million individuals in the United States alone. Patients experience multiple symptoms in addition to pain, and among them, fatigue is one of the most bothersome and disabling. There is a growing body of literature suggesting that fatigue is a multidimensional concept. Currently, to our knowledge, no multidimensional Patient Reported Outcome (PRO) measure of FM-related fatigue meets Food and Drug Administration (FDA) requirements to support a product label claim. Therefore, the objective of this research was to evaluate qualitative and quantitative data previously gathered to inform the development of a comprehensive, multidimensional, PRO measure to assess FM-related fatigue in FM clinical trials.Methods: Existing qualitative and quantitative data from three previously conducted studies in patients with FM were reviewed to inform the initial development of a multidimensional PRO measure of FM-related fatigue: 1) a concept elicitation study involving in-depth, open-ended interviews with patients with FM in the United States (US) (N = 20), Germany (N = 10), and France (N = 10); 2) a cognitive debriefing and pilot study of a preliminary pool of 23 items (N = 20 US patients with FM); and 3) a methodology study that explored initial psychometrics of the item pool (N = 145 US patients with FM).Results: Five domains were identified that intend to capture the broad experience of FM-related fatigue reported in the qualitative research: the Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Seventeen of the original pool of 23 items were selected to best capture these five dimensions. These 17 items formed the basis of a newly developed multidimensional PRO measure to assess FM-related fatigue in clinical trials: the Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 (MDF-Fibro-17).Conclusion: Qualitative analysis, and preliminary quantitative item level data, confirmed that FM-related fatigue is multidimensional and provided strong support for the content validity of the MDF-Fibro-17. The next stage was to quantitatively evaluate the measure to confirm the factor structure, psychometric properties, sensitivity to change, and meaningful change. This has been conducted and is being reported separately. [ABSTRACT FROM AUTHOR]

Background: The Western Ontario Rotator Cuff Index (WORC) is a widely used instrument to measure quality of life in patients with subacromial pain or rotator cuff syndrome. The purpose of this study was to evaluate the psychometric properties of the Swedish version of the WORC for assessment of subacromial disease including rotator cuff syndrome treated by surgery. Methods: A total of 65 patients were included in this study, mean age 60 years (range 36-82), 42% women, all were candidates for surgery for subacromial pain conditions at two orthopedic units during 2004-2006 and 2011-2012. Calculations of the validity of Pearson's correlation coefficient, floor and ceiling effects, reliability and responsiveness have formed the basis of assessment of the WORC index properties. WORC has been tested against Western Ontario Osteoarthritis of the Shoulder (WOOS), Oxford Shoulder Score and EQ-5D. An additional 49 patients, mean age 64 years (range 36-74) 20% of whom were women, were analyzed in a WORC test-retest with ICC and also correlated to Constant-Murley Score. Results: The validity analysis of WORC showed high correlations with both the specific and the generic health measurement instrument. The reliability calculations of the WORC resulted in ICC = 0.97 and Cronbach's alpha = 0.97. Responsiveness was also excellent for WORC with Effect size = 1.35 and Standardized Response mean = 1.01. We found that the WORC showed a strong correlation with the WOOS (0.97) and the Constant-Murley Score (0.85). A good correlation was found with the Oxford Shoulder Score (0.74) and the EQ-5D (0.71). Conclusions: The Swedish version of WORC can be considered reliable, valid and responsive for use as an assessment of outcome and a health measurement instrument for patients treated by surgery for subacromial disease including rotator cuff syndrome. [ABSTRACT FROM AUTHOR]

Background: Previous studies have provided the initial evidence for construct validity and test-retest reliability of the Mayo Hip Score. Instruments used for Total Hip Arthroplasty (THA) outcomes assessment should be valid, reliable and responsive to change. Our main objective was to examine the responsiveness to change, association with subsequent revision and the construct validity of the Mayo hip score.Methods: Discriminant ability was assessed by calculating effect size (ES), standardized response mean (SRM) and Guyatt's responsiveness index (GRI). Minimal clinically important difference (MCII) and moderate improvement thresholds were calculated. We assessed construct validity by examining association of scores with preoperative patient characteristics and correlation with Harris hip score, and assessed association of scores with the risk of subsequent revision.Results: Five thousand three hundred seven provided baseline data; of those with baseline data, 2,278 and 2,089 (39%) provided 2- and 5-year data, respectively. Large ES, SRM and GRI ranging 2.66-2.78, 2.42-2.61 and 1.67-1.88 were noted for Mayo hip scores with THA, respectively. The MCII and moderate improvement thresholds were 22.4-22.7 and 39.4-40.5 respectively. Hazard ratios of revision surgery were higher with lower final score or less improvement in Mayo hip score at 2-years and borderline significant/non-significant at 5-years, respectively: (1) score ≤55 with hazard ratios of 2.24 (95% CI, 1.45, 3.46; p = 0.0003) and 1.70 (95% CI, 1.00, 2.92; p = 0.05) of implant revision subsequently, compared to 72-80 points; (2) no improvement or worsening score with hazard ratios 3.94 (95% CI, 1.50, 10.30; p = 0.005) and 2.72 (95% CI, 0.85,8.70; p = 0.09), compared to improvement >50-points. Mayo hip score had significant positive correlation with younger age, male gender, lower BMI, lower ASA class and lower Deyo-Charlson index (p ≤ 0.003 for each) and with Harris hip scores (p < 0.001).Conclusions: Mayo Hip Score is valid, sensitive to change and associated with future risk of revision surgery in patients with primary THA. [ABSTRACT FROM AUTHOR]

Background Assessed dimensions of low back pain (LBP) vary in prevalence studies. This may explain the heterogeneity in frequency estimates. To standardize definitions of LBP, an English consensus with 28 experts from 12 countries developed the "Delphi Definitions of Low Back Pain Prevalence" (DOLBaPP). The optimal definition and the shorter minimal definition with the related questionnaires for online, paper, and face-to-face use and telephone surveys are suitable for population-based studies. The definitions have to be adapted to different languages and cultures to provide comparable frequency estimates. The objective was to culturally adapt and pre-test the English definitions and corresponding Delphi DOLBaPP questionnaire forms into German. Methods The German DOLBaPP adaptation was conducted using the systematic approach suggested by Beaton et al. A pre-test of the Delphi DOLBaPP optimal paper questionnaire including an additional evaluation form was conducted in a sample of 121 employees (mainly office workers). In order to evaluate the comprehensibility, usability, applicability, and completeness of the adapted questionnaire, response to the questionnaire and 6 closed evaluation questions were analyzed descriptively. Qualitative methods were used for the 3 open questions of the evaluation form. Results The cultural adaptation of the DOLBaPP for a German-speaking audience required little linguistic adaptation. Conceptual equivalence was difficult for the expression "low back pain". The expert committee considered the face validity of the pre-final version of the related Delphi DOLBaPP questionnaires as good. In the pre-test, most participants (95%) needed less than 5 minutes to fill in the optimal Delphi DOLBaPP questionnaire. They were generally positive regarding length, wording, diagram, and composition. All subjects with LBP (n = 61 out of 121 - 50.4%) answered the questions on functional limitation, sciatic pain, frequency and duration of symptoms as well as pain severity. Conclusion The results indicate that the cross-cultural German adaptation of the DOLBaPP Definitions and the corresponding questionnaires was successful. The definitions can be used in epidemiological studies to measure the prevalence of LBP. Some critical issues were raised regarding the general features of the Delphi DOLBaPP questionnaires. Future research is needed to evaluate these instruments. [ABSTRACT FROM AUTHOR]

Background The Western Ontario Shoulder Instability index (WOSI) is a patient-reported outcome measure for patients with shoulder instability. The purpose of this study was to validate the WOSI in a Dutch population by evaluating its structural validity, internal consistency, measurement error, reliability, and construct validity. Floor and ceiling effects were also addressed. Methods Two cohorts were recruited, including a total of 138 patients with shoulder instability. Confirmatory factor analysis was used to assess the structural validity and Cronbach's α to assess internal consistency. The measurement error was calculated as the smallest detectable change (SDC). Reliability (test-retest) was estimated in a subgroup of 99 patients who completed the re-test after a mean of 13 days (5-30 days). Reliability was calculated with the intraclass correlation coefficient (ICC). Construct validity was evaluated by comparing the WOSI with the Oxford Shoulder Instability Score (OSIS), the Simple Shoulder Test, the Oxford Shoulder Score, the Disability of the Arm, Shoulder, and Hand assessment (DASH), and the Short Form-36 Health Survey. Measurement properties were evaluated for both the total WOSI score and its four domains. Results Factor analysis did not confirm the validity of the four domains. Best results were found for a one-factor model. Internal consistency was good, with Cronbach's α ranging from 0.93 to 0.96. Reliability was excellent (ICC 0.88-0.92 for all subscales). The measurement error (SDC) was 23.0% for the total WOSI and 23% to 28% for the subscales (on a scale of 0- 100). Regarding the construct validity, 76% of the results were in accordance with the hypotheses, including a high correlation with the OSIS (0.82) and DASH (0.81) assessments. No floor or ceiling effects were found. Conclusion The Dutch version of WOSI showed good reliability and validity in a cohort of patients with shoulder instability, although the factor structure remains unclear. [ABSTRACT FROM AUTHOR]

Background Head-eye movement control deficit is an identified problem in patients with chronic neck pain, particularly in cases of whiplash associated disorders (WAD). To date, there is no evidence concerning the reliability and validity of visually assessed active head-eye movement control tests. Therefore, the objectives of the present cross-sectional study were, a) to develop a test battery; and b) to investigate inter-observer reliability and discriminative validity in patients with chronic neck pain compared to healthy controls. Methods The study was conducted at two physiotherapy clinics in Switzerland. Ethics Committee approval was obtained. Ten active head-eye coordination tests, on 23 patients with chronic neck pain and associated symptoms and 19 healthy controls, were videotaped. The tests included eye movements in the neutral head position and 45° relative neck rotation, gaze stability and sequential head-eye movements. All tests were performed in the sitting and standing positions. Two blinded physiotherapists independently rated the randomized videos. Performance was rated as "negative", "moderately positive" or "clearly positive". Weighted kappa (wK) and 95% confidence intervals (CI) were calculated to investigate inter-observer reliability. Good reliability was defined as wK >0.5 with a lower boundary of 95% CI >0.2. Odds ratios (to define cut-off points) and the distribution of the classificator, numbers of positive tests, were calculated. Results Three out of ten tests showed "excellent" (wK 0.82 to 0.86), five out of ten tests showed "substantial" (wK 0.69 to 0.79) and two out of ten tests showed "moderate" (wK 0.54 to 0.59) reliability. Results were comparable in the sitting and standing positions. On average, three out of five tests were rated positive in patients and one out of five tests was rated positive in healthy controls. An odds ratio of 13.3 to 18.6 was obtained using ≧2/5 tests as a cut-off point. Conclusion Visual assessment by physiotherapists of head-eye movement control tests is reliable. The test battery is able to discriminate between patients with chronic neck pain and healthy controls. There were no differences in performance between the sitting and standing positions. The test battery can therefore be reduced to five tests. Further research is needed to identify the test-retest stability and responsiveness. [ABSTRACT FROM AUTHOR]

Background The purpose of this study was the development of a valid and reliable “Mechanical and Inflammatory Low Back Pain Index” (MIL) for assessment of non-specific low back pain (NSLBP). This 7-item tool assists practitioners in determining whether symptoms are predominantly mechanical or inflammatory. Methods Participants (n = 170, 96 females, age = 38 ± 14 years-old) with NSLP were referred to two Spanish physiotherapy clinics and completed the MIL and the following measures: the Roland Morris Questionnaire (RMQ), SF-12 and “Backache Index” (BAI) physical assessment test. For test-retest reliability, 37 consecutive patients were assessed at baseline and three days later during a non-treatment period. Face and content validity, practical characteristics, factor analysis, internal consistency, discriminant validity and convergent validity were assessed from the full sample. Results A total of 27 potential items that had been identified for inclusion were subsequently reduced to 11 by an expert panel. Four items were then removed due to cross-loading under confirmatory factor analysis where a two-factor model yielded a good fit to the data (χ2 = 14.80, df = 13, p = 0.37, CFI = 0.98, and RMSEA = 0.029). The internal consistency was moderate (α = 0.68 for MLBP; 0.72 for ILBP), test-retest reliability high (ICC = 0.91; 95%CI = 0.88-0.93) and discriminant validity good for either MLBP (AUC = 0.74) and ILBP (AUC = 0.92). Convergent validity was demonstrated through similar but weak correlations between the ILBP and both the RMQ and BAI (r = 0.34, p < 0.001) and the MLBP and BAI (r = 0.38, p < 0.001). Conclusions The MIL is a valid and reliable clinical tool for patients with NSLBP that discriminates between mechanical and inflammatory LBP. [ABSTRACT FROM AUTHOR]

Background: In epidemiological studies on neck-shoulder disorders, physical examination by health professionals, although more expensive, is usually considered a better method of data collection than self-administered questionnaires on symptoms. However, little is known on the comparison of these two methods of data collection. The agreement between self-administered questionnaires and the physical examination on the presence of neck-shoulders disorders was assessed in the present study. Methods: This study was conducted among clerical workers using video display units. Prevalent cases were workers for whom neck-shoulder symptoms were present for at least 3 days during the previous 7 days and for whom pain intensity was greater than 50 mm on a 100 mm visual analogue scale. All 85 workers meeting this definition and a random sample of 102 workers who did not meet this definition were selected. Physical examination included measures of active range of motion and musculoskeletal strength. Cohen's kappa and global percent agreement were calculated to compare the two methods of data collection. The effect on the agreement of different question and physical examination definitions and the importance of the time interval elapsed between the administrations of the tests were also evaluated. Results: Kappa coefficients ranged from 0.19 to 0.54 depending on the definitions used to ascertain disorders. The agreement was highest when the two instruments were administered 21 days apart or less (Kappa = 0.54, global agreement = 77%). It was not substantially improved by the addition of criteria related to functional limitations or when comparisons were made with alternative physical examination definitions. Pain intensity recorded during physical examination maneuvers was an important element of the agreement between questionnaire and physical examination findings. Conclusion: These results suggest a fair to good agreement between the presence of musculoskeletal disorders ascertained by self-administered questionnaire and physical examination that may reflect differences in the constructs measured. Shorter time lags result in better agreement. Investigators should consider these results before choosing a method to measure the presence of musculoskeletal disorders in the neck-shoulder region. [ABSTRACT FROM AUTHOR]

Background: The Pictorial Fear of Activity Scale-Cervical (PFActS-C) is a reliable and valid instrument to assess fear of movement in people with whiplash associated disorders. It is not available in Dutch and has not been evaluated in other neck pain populations. This study aimed to systematically translate the PFActS-C into Dutch and evaluate the psychometric properties of this Dutch Language Version (DLV) in people with non-specific neck pain.Methods: The PFActS-C was translated according to international guidelines. Internal consistency, test-retest reliability, floor and ceiling effects, face validity and construct validity (convergent and discriminant validity by hypotheses testing and structural validity by confirmatory and exploratory factor-analyses) of the PFActS-C-DLV were tested in 125 people with non-specific neck pain.Results: The PFActS-C-DLV showed good to excellent internal consistency (Cronbach's alpha: 0.98) and stability over time (ICC: 0.90 [95%CI: 0.82-0.93). Four out of five a priori formulated hypotheses regarding related (convergent validity) and unrelated (discriminant validity) constructs were confirmed. However, the confirmatory factor analysis could not confirm the expected 1-factor solution. Furthermore, the exploratory factor analyses revealed that also a higher factor solution would not lead to a good fit of the model.Conclusions: The PFActS-C-DLV is a reliable region-specific instrument for people with non-specific neck pain. The construct validity was supported, based on hypotheses testing. However, factor analyses could not confirm a 1-factor solution, so the underlying construct of the PFActS-C-DLV remains unclear. Given the PFActS-C's photographic format, we believe these findings also have relevance for the original English version. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

Background: To determine the longitudinal construct validity of assessing hand OA progression on digital photographs over 7 years compared with progression determined from radiographs, clinical features and change in symptoms.Methods: Participants were community-dwelling older adults (≥50 years) in North Staffordshire, UK. Standardized digital hand photographs were taken at baseline and 7 years, and hand joints graded for OA severity using an established photographic atlas. Radiographic hand OA was assessed using the Kellgren and Lawrence grading system. Hand examination determined the presence of nodes, bony enlargement and deformity. Symptoms were reported in self-complete questionnaires. Radiographic and clinical progression and change in symptoms were compared to photographic progression. Differences were examined using analysis of covariance and Chi-Square tests.Results: Of 253 individuals (61% women, mean age 63 years) the proportion with photographic progression at the joint and joint group-level was higher in individuals with radiographic or clinical progression compared to those without, although differences were not statistically significant. At the person-level, those with moderate photographic progression over 7 years had significantly higher summed radiographic and clinical scores (adjusted for baseline scores) compared to those with no or mild photographic progression. Similar findings were observed for change in symptoms, although differences were small and not statistically significant.Conclusion: Assessing hand OA on photographs shows modest longitudinal construct validity over 7 years compared with change in radiographic and clinical hand OA at the person-level. Using photographs to assess overall long-term change in a person with hand OA may be a reasonable alternative when hand examinations and radiographs are not feasible. [ABSTRACT FROM AUTHOR]

Background: Individuals afflicted with nonspecific chronic low back pain (CLBP) exhibit altered fundamental movement patterns. However, there is a lack of validated analysis tools. The present study aimed to elucidate the measurement properties of a functional movement analysis (FMA) in patients with CLBP.Methods: In this validation (cross-sectional) study, patients with CLPB completed the FMA. The FMA consists of 11 standardised motor tasks mimicking activities of daily living. Four investigators (two experts and two novices) evaluated each item using an ordinal scale (0-5 points, one live and three video ratings). Interrater reliability was computed for the total score (maximum 55 points) using intra class correlation and for the individual items using Cohen's weighted Kappa and free-marginal Kappa. Validity was estimated by calculating Spearman's Rho correlations to compare the results of the movement analysis and the participants' self-reported disability, and fear of movement.Results: Twenty-one participants (12 females, 9 males; 42.7 ± 14.3 years) were included. The reliability analysis for the sum score yielded ICC values between .92 and.94 (p < .05). The classification of individual scores are categorised 'slight' to 'almost perfect' agreement (.10-.91). No significant associations between disability or fear of movement with the overall score were found (p > .05). The study population showed comparably low pain levels, low scores of kinesiophobia and disability.Conclusion: The functional movement analysis displays excellent reliability for both, live and video rating. Due to the low levels of disability and pain in the present sample, further research is necessary to conclusively judge validity. [ABSTRACT FROM AUTHOR]

Background: To determine the known-group validity, a type of construct validity, and the test-retest reliability of a newly developed tool, the Personalized Exercise Questionnaire (PEQ), that assesses the barriers, facilitators, and preferences to exercise in individuals with low bone mass and osteoporosis.Methods: A comparative design was used to assess known-group validity and a test-retest design to examine the reproducibility. Ninety-five participants with low bone mass and osteoporosis were recruited from an outpatient clinic in Hamilton, Ontario. The questionnaire was administered to 95 participants at baseline and a subset of 42 participants completed the survey again one week later. The known-group validity of the PEQ was determined using four hypotheses that compared two known groups based on employment level, age, socioeconomic status, and physical activity level. The reproducibility of individual responses was analyzed using the Kappa Coefficient (κ).Results: There was known-group validity for three of the four hypotheses. Test-retest reliability scores ranged from no agreement to almost perfect agreement; seven items had almost perfect agreement (κ: 0.81-1.00), 12 substantial agreement (κ: 0.68-0.74), six moderate agreement (κ: 0.56-0.60), two fair agreement (κ: 0.36-0.40), one slight agreement (κ = 0.23) and one no agreement (κ = - 0.03).Conclusion: Preliminary support for the usefulness of the PEQ is indicated since the majority of the items had at least substantial agreement and known-group validity was moderately supported for some items.Trial Registration: This study was retrospectively registered with ClinicalTrials.gov , NCT03125590, on April 24, 2017. [ABSTRACT FROM AUTHOR]

Background: Valid and reliable patient-reported outcome measures support health professionals in evaluating the results of clinical research and practice. The Copenhagen Neck Functional Disability Scale (CNFDS) has shown promising measurement properties to measure disability in patients with neck pain, but an Italian version of this questionnaire is not available. The objective of this study was to cross-culturally adapt the CNFDS into Italian (CNFDS-I), and to assess its validity and reliability in patients with neck pain.Methods: The CNFDS-I was developed according to well-established guidelines for cross-cultural adaptation of patient-reported outcome measures. A cross-sectional clinimetric study was conducted to evaluate its validity and reliability. Patients with chronic neck pain (pain > 3 months) participated in this study. The following measurement properties (defined by the COSMIN initiative) were assessed: structural validity (exploratory factor analysis), internal consistency (Cronbach's α), construct validity [by testing hypotheses on expected correlations with the Neck Disability Index (NDI), the Neck Bournemouth Questionnaire (NBQ), and pain Visual Analogue Scale (VAS)]. Test-retest reliability [Intraclass Correlation Coefficient for agreement (ICCagreement)], and measurement error [Smallest Detectable Change (SDC)] were also assessed in 50 clinically stable patients. Floor/ceiling effects and acceptability were calculated.Results: One-hundred and sixty-two patients (mean age = 47.9 ± 14.5 years, 70% female) were included. The CNFDS-I exhibited sufficient unidimensionality (one factor explained 83% of the variability) and internal consistency (α = 0.83). Construct validity was sufficient as all correlations with the other questionnaires were as expected (r = 0.846 with NDI, r = 0.708 with NBQ, r = 0.570 with VAS). Test-retest reliability was excellent (ICCagreement = 0.99, 95% CI from 0.995 to 0.999), while measurement error was equal to 8.31 scale points (27% scale range). No floor/ceiling effects were detected. The average time for filling the questionnaire was two minutes.Conclusions: The CNFDS-I proved to be a valid and reliable outcome measure to assess disability in patients with chronic neck pain. Head-to-head comparison studies on the CNFDS-I measurement properties against other disability measures for neck pain (e.g. NDI and NBQ) are required to determine the relative merits of these different measures. [ABSTRACT FROM AUTHOR]