Validation of the Swedish Version of Western Ontario Osteoarthritis of the Shoulder Index

BackgroundThe Western Ontario of the Shoulder index (WOOS) is a patient-reported, disease-specific instrument, designed to measure quality of life in patients with osteoarthritis of the shoulder. The Swedish Shoulder Arthroplasty Registry (SSAR) uses WOOS and EuroQoL 5-dimensions 3 levels (EQ-5D-3L) as patient reported outcome measures. The purpose of this study was to test the validity, responsiveness, and reliability of the Swedish translation of WOOS for patients with osteoarthritis of the shoulder.MethodsData was collected from three shoulder arthroplasty studies performed during 2005-2013, with 23, 21, and 19 patients respectively. Forms were collected preoperatively, and postoperatively between 12 and 24 months. WOOS and EQ-5D-3L were used in all three studies. Additionally, the Oxford Shoulder Score (OSS) (n=23) was used in one study, and the Constant-Murley score (CMS) (n=40) in two of the studies. Validity was analysed by calculating Pearson’s correlation coefficient (PCC). Cronbach’s alpha (CA) was used to estimate internal consistency and reliability. The responsiveness of WOOS was measured by calculating effect size and standardized response mean. To assess the performance of WOOS over time, we present repeated measures of WOOS in the registry over a 10-year period.ResultsThe validity analysis showed excellent correlations of WOOS to CMS, OSS and EQ-5D 3L, with Pearson’s correlation coefficient of 0.72, 0.83, and 0.62 respectively (P<0.001). There were adequate floor effects in the sport and lifestyle domains preoperatively, and adequate ceiling effects in all domains postoperatively. There were no floor effects and adequate ceiling effects for total WOOS. Analyzing reliability, Cronbach’s alpha was 0.95 for the pre- and postoperative WOOS scores combined. The analysis of responsiveness for WOOS showed an effect size of 2.52 and a standardized response mean of 1.43.The individual results measured by WOOS within the registry shows stable levels from 1 to 10 years.ConclusionThe Swedish translation of WOOS is valid, reliable, and responsive for use in a clinical setting for patients with glenohumeral osteoarthritis treated with shoulder arthroplasty, and we regard it as an appropriate instrument for use in the Swedish Shoulder Arthroplasty Registry.

The German version of the Stroke Upper Limb Capacity Scale: Translation, cross-cultural adaption and evaluation of its psychometric properties

Objective: To investigate the psychometric properties of a newly developed German version of the Stroke Upper Limb Capacity Scale (SULCS). Design: Prospective cohort study. Setting: Neurorehabilitation clinic. Subjects: Patients after stroke ( n = 50) with moderate to severe upper limb hemiparesis undergoing inpatient rehabilitation. Intervention: Not applicable. Main measures: The SULCS was administered twice by two different raters on the first day of assessments and another time the day after. Additionally the Fugl-Meyer-Assessment, Action Research Arm Test and the Box and Block Test were conducted. Three and six weeks later, the SULCS, Fugl-Meyer-Assessment and Box and Block Test were repeated. Floor and ceiling effects were analyzed. Results: Reliability was demonstrated to be excellent as displayed by weighted kappa of 0.960 (95%-confidence interval: CIκw = 0.808–1.112) for the intra-rater reliability and 0.936 (CIκw = 0.749–1.123) for the inter-rater reliability. High correlations of the SULCS with the Fugl-Meyer-Assessment (ρ = 0.889), Action Research Arm Test (ρ = 0.872), and Box and Block Test (ρ = 0.845; all P < 0.001) confirmed a high convergent validity. The longitudinal validity was determined by a moderate to high correlation of the SULCS and Box and Block Test changes (ρ ⩾ 0.695, P ⩽ 0.001). Although floor effects were observed for the SULCS (16%), they were more substantial for the Action Research Arm Test and the Box and Block Test (>38%). Conclusion: Due to the good to excellent psychometric properties and the low level of floor effects of the German version of the SULCS, the usage for clinical and scientific purposes can be recommended.

Translation, cross-cultural adaptation, reliability and construct validity of the Dutch Oxford Knee Score – Activity and Participation Questionnaire

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.

Normative PROMIS Scores in Healthy Collegiate Athletes: Establishing a Target for Return to Function in the Young Adult Athlete

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) computer-adaptive testing (CAT) has been shown to be a valid and reliable means of assessing patient-reported outcomes. However, normal scores and distributions for a subset of a healthy young athletic population have not been established. Purpose: To establish normative PROMIS scores for the domains of Physical Function (PF-CAT), Mobility (M-CAT), Upper Extremity Function (UE-CAT), and Pain Interference (PI-CAT) and determine the frequency of floor and ceiling effects in a population of healthy collegiate athletes. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Healthy collegiate athletes (18-23 years of age) were prospectively enrolled to complete the 4 PROMIS CAT domains. Additionally, the athletes provided information regarding their age, sex, and sport(s). Mean scores (±SD) and identification of ceiling or floor effects were calculated. Ceiling and floor effects were considered significant if >15% of the participants obtained the highest or lowest possible score on a domain. Results: A total of 194 healthy athletes (mean age, 19.1 years) were included in the study: 118 (60.8%) men and 76 (39.2%) women. Mean scores were 62.9 ± 6.7 for PF-CAT, 58.2 ± 4.1 for M-CAT, 57.4 ± 5.8 for UE-CAT, and 43.2 ± 6.2 for PI-CAT. Distributions of scores for M-CAT and UE-CAT indicated strong ceiling effects by 77.3% and 66.0% of the participants, respectively. In healthy athletes, the PF-CAT differed most from the expected population-based mean score (50), with the mean being >1 SD above (62.9), without a ceiling effect observed. There were no significant sex- or age-based differences on any of the PROMIS domain scores. Conclusion: Healthy collegiate athletes scored nearly 1 SD from population-based means for all of the domains tested. M-CAT and UE-CAT demonstrated ceiling effects in more than two-thirds of healthy athletes, which may limit their utility in this population. The PF-CAT did not demonstrate floor or ceiling effects and demonstrated differences in a young adult athletic population from the population mean. The mean PF-CAT score of 62.9 can represent a target for return of function in injured athletes.

Convergent validity, ceiling, and floor effects of the English-ISYQOL against established quality of life questionnaires (SRS-22r and SAQ) and curve angles in adolescents with idiopathic scoliosis

Scoliosis significantly impacts Quality of Life (QOL). Current quality of life questionnaires for adolescents with idiopathic scoliosis (AIS) have limitations. A new questionnaire for measuring QOL in AIS called the Italian Spine Youth Quality of Life (ISYQOL) has been developed to address these limitations but the English translation has not yet been validated. To determine the ceiling and floor effects, and the convergent validity of the ISYQOL questionnaire against established QOL questionnaires and Cobb angle in AIS. One hundred consecutive females with AIS, (10–18 years old), treated non-operatively. The English translation of the ISYQOL was compared to the following established questionnaires: Scoliosis Research Society-22r and the Spinal Appearance Questionnaire. The participants were 100 females (13.89+/-1.8 years) with 28.75+/-13.9° curve angles. The convergent validity of the ISYQOL score (60.3+/-12.44) was supported by significant correlation with the SRS-22r total score, function, pain, self-image, and mental health scores (r = 0.70, 0.54, 0.57, 0.52 and 0.50, respectively), and with the SAQ general, waist, and expectations domains (r = -0.6. -.52, and -0.56, respectively). Correlation with the Cobb angle was (r = -.37)(see Table 1). No ceiling effect was observed in the ISYQOL. Ceiling effects were observed for the SRS-22r and the SAQ. The ISYQOL demonstrated evidence of convergent validity. This study supports its suitability for QOL research in AIS. ISYQOL appears more likely to detect changes in evaluative studies than the SRS- 22r and the SAQ.

Non-invasive electrophysiology in glaucoma, structure and function—a review

Glaucoma, its early diagnosis, and monitoring of interventions remain an ongoing challenge. We here review developments in functional assessment and its relation to morphology, evaluating recent insights in electrophysiology in glaucoma and highlighting how glaucoma research and diagnostics benefit from combined approaches of OCT and electrophysiological investigations. After concise overviews of OCT and non-invasive electrophysiology in glaucoma, we evaluate commonalities and complementarities of OCT and electrophysiology for our understanding of glaucoma. As a specific topic, the dynamic range (floor effects) of the various techniques is discussed.

Measuring physical function in psoriatic arthritis: comparing the Multi-Dimensional Health Assessment Questionnaire to the Health Assessment Questionnaire Disability Index

Objective To compare physical function scales of the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) to the Health Assessment Questionnaire Disability Index (HAQDI) in patients with psoriatic arthritis (PsA), and examine whether either questionnaire is less prone to ‘floor effects’. Methods Data were collected prospectively from 2018 to 2019 across three UK hospitals. All patients completed physical function scales within the MDHAQ and HAQDI in a single clinic visit. Agreement was assessed using medians and the Bland-Altman method. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. Results 210 patients completed the clinic visit; one withdrew consent thus 209 were analysed. 60.0% were male, with mean age of 51.7 years and median disease duration of 7 years. In clinic, median MDHAQ and HAQDI including/excluding aids scores were 0.30, 0.50 and 0.50 respectively. Although the median score for HAQDI is higher than MDHAQ, the difference between the two mostly lies within 1.96 standard deviations from the mean suggesting good agreement. The ICCs demonstrated excellent test-retest reliability for both HAQ questionnaires.Similar numbers of patients scored ‘0’ on the MDHAQ and HAQDI including/excluding aids (48, 47, and 49 respectively). Using a score of ≤0.5 as a cut-off for minor functional impairment, 23 patients had a MDHAQ ≤0.5 when their HAQDI including aids >0.5. Conversely, 4 patients had a MDHAQ > 0.5 when the HAQDI including aids ≤0.5. ConclusionBoth HAQ questionnaires appear to be similar in detecting floor effects in patients with PsA.

Validity, reliability, and ceiling and floor effects of the PROMIS Preference score (PROPr) in patients with rheumatological and psychosomatic conditions

Background: The PROMIS Preference score (PROPr) is a new generic preference-based health-related quality of life (HRQoL) score that can be used as a health state utility (HSU) score for quality-adjusted life years (QALYs) in cost-utility analyses (CUAs). It is the first HSU score based on item response theory (IRT) and has favorable psychometric properties. The PROPr combines the seven PROMIS domains: cognition, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. It was developed based on preferences of the US general population. We aimed to validate the PROPr in a patient sample and to compare it to the EQ-5D. Methods: We collected PROPr and EQ-5D-5L data from 141 patients treated in the rheumatology and psychosomatic departments. We evaluated the convergent validity, reliability, known-groups construct validity, and ceiling and floor effects of the PROPr and compared those characteristics to those of the EQ-5D. Results: The mean PROPr (0.26, 95% CI: 0.23; 0.29) and the mean EQ-5D (0.44, 95% CI: 0.38; 0.51) differed significantly (d = 0.18, p < 0.001). The Pearson correlation coefficient between the two scores was r = 0.72. The PROPr and EQ-5D demonstrated high reliability and similar discrimination power across sex, age, and conditions. While the PROPr showed a floor effect, the EQ-5D showed a ceiling effect. Conclusion: PROPr and EQ-5D measure HSU differently. The PROPr shows a broader definition of perfect health, with a wider range of measurements at the top end. The previous results of excellent validity and precision were confirmed.

Responsiveness and interpretability of commonly used outcome assessments of mobility capacity in older hospital patients with cognitive spectrum disorders

Background In older hospital patients with cognitive spectrum disorders (CSD), mobility should be monitored frequently with standardised and psychometrically sound measurement instruments. This study aimed to examine the responsiveness, minimal important change (MIC), floor effects and ceiling effects of commonly used outcome assessments of mobility capacity in older patients with dementia, delirium or other cognitive impairment. Methods In a cross-sectional study that included acute older hospital patients with CSD (study period: 02/2015–12/2015), the following mobility assessments were applied: de Morton Mobility Index (DEMMI), Hierarchical Assessment of Balance and Mobility (HABAM), Performance Oriented Mobility Assessment, Short Physical Performance Battery, 4-m gait speed test, 5-times chair rise test, 2-min walk test, Timed Up and Go test, Barthel Index mobility subscale, and Functional Ambulation Categories. These assessments were administered shorty after hospital admission (baseline) and repeated prior to discharge (follow-up). Global rating of mobility change scales and a clinical anchor of functional ambulation were used as external criteria to determine the area under the curve (AUC). Construct- and anchor-based approaches determined responsiveness. MIC values for each instrument were established from different anchor- and distribution-based approaches. Results Of the 63 participants (age range: 69–94 years) completing follow-up assessments with mild (Mini Mental State Examination: 19–24 points; 67%) and moderate (10–18 points; 33%) cognitive impairment, 25% were diagnosed with dementia alone, 13% with delirium alone, 11% with delirium superimposed on dementia and 51% with another cognitive impairment. The follow-up assessment was performed 10.8 ± 2.5 (range: 7–17) days on average after the baseline assessment. The DEMMI was the most responsive mobility assessment (all AUC > 0.7). For the other instruments, the data provided conflicting evidence of responsiveness, or evidence of no responsiveness. MIC values for each instrument varied depending on the method used for calculation. The DEMMI and HABAM were the only instruments without floor or ceiling effects. Conclusions Most outcome assessments of mobility capacity seem insufficiently responsive to change in older hospital patients with CSD. The significant floor effects of most instruments further limit the monitoring of mobility alterations over time in this population. The DEMMI was the only instrument that was able to distinguish clinically important changes from measurement error. Trial registration German Clinical Trials Register (DRKS00005591). Registered February 2, 2015.