Guyatt's Responsiveness Index Research Articles

Reliability, validity, and responsiveness of the Indonesian version of the Lysholm knee score and Tegner activity scale in patients with anterior cruciate ligament reconstruction

ObjectivesThis study aims to examine the reliability, validity, and responsiveness of the Lysholm knee score (LKS) and Tegner activity scale (TAS) in Indonesian patients with anterior cruciate ligament reconstruction (ACLR). DesignCross-sectional study. SettingThe LKS and TAS were translated into Indonesian through standardized procedures with the owners' permission, and the test-retest reliabilities, validities, and responsiveness were performed. ParticipantsData of LS, TAS, Short Form (SF)-36, as well as MRI results were collected from 206 patients with unilateral ACLR. Main outcome measuresLKS and TAS. ResultsThe questionnaires showed an adequate interclass correlation coefficient of 0.81–0.84 for the test-retest reliabilities, while an appropriate Cronbach's alpha value of 0.83 was obtained for internal consistency using LKS. They also had moderate-high correlations with the selected measures, which have similar constructs (r values, 0.44–0.68) except for the TAS with SF-36 physical function (PF; r value, 0.32). Meanwhile, low associations were observed with other measures with different constructs (r, 0.21–0.31). The results showed that Guyatt's responsiveness index for LKS and TAS changed in the SF-36's PF from 0.50 to 1.60 after one year. ConclusionsThe Indonesian version of LKS and TAS have acceptable reliabilities, validities, and responsiveness in ACLR patients.

Psychometric validation of the simplified Chinese Copenhagen Neck Functional Disability Scale in patients with chronic nonspecific neck pain.

Reliable and valid measurement tools are crucial for clinical practice in chronic nonspecific neck pain (CNSNP). The Copenhagen Neck Functional Disability Scale (CNFDS) is a widely used scale in neck pain assessment and has its unique advantages, but it is not available for patients with CNSNP in southern China. To develop the simplified Chinese version of CNFDS (CNFDS-SC) cross-culturally and to investigate its measurement properties in patients with CNSNP. Cross-sectional study. Validation of neck pain measurement scale in southern China. One hundred five patients with CNSNP. Not applicable. Internal consistency and test-retest reliability were evaluated using Cronbach's alpha and intraclass correlation coefficient (ICC), respectively. Construct validity and structural validity were validated by hypothesis testing and exploratory factor analysis, respectively. Internal and external responsiveness were validated. Interpretability was revealed by the standard error of measurement (SEM) and smallest detectable change (SDC). Internal consistency (Cronbach's alpha=0.77 for first test and 0.84 for retest) and test-retest reliability (ICC=0.95) were satisfactory. CNFDS-SC scores showed strong correlations with the numeric rating scale (NRS), the Neck Disability Index (NDI), and the Northwick Park Neck Pain Questionnaire (NPQ) scores (r=0.652, 0.763, and 0.719, respectively; p < .001). Factor analysis revealed a one-factor structure of the scale. Regarding responsiveness, the standardized response mean (SRM) and the Guyatt's responsiveness index (GRI) were 1.29 and 2.12, respectively. CNFDS-SC change scores showed good correlations with the anchoring question (r=0.619, p < .001), NDI (r=0.439, p=.001), and NPQ (r=0.438 p=.001) change scores; the area under the receiver-operating characteristic (ROC) curve was 0.89 (p < .001). The SEM and SDC were 0.93 and 2.57, respectively. No floor or ceiling effect and no missing items were observed. The CNFDS-SC was demonstrated with adequate reliability, validity, responsiveness, and interpretability. The CNFDS-SC could be an effective tool for the clinical assessment of patients with CNSNP in southern China.

The responsiveness and validity of the Rotator Cuff Quality of Life (RC-QOL) index in a 2-year follow-up study.

BackgroundThe Rotator Cuff Quality of Life (RC-QOL) index was developed to evaluate quality of life in patients with rotator cuff disease. This study provides additional psychometric testing in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments guidelines.MethodsThis was a 2-year follow-up study on 66 patients (mean age, 59 ± 10 years) originally presenting with chronic full-thickness rotator cuff tears to a tertiary care center. The methodology involved testing internal consistency, content validity, and criterion validity. Responsiveness was evaluated using 3 strategies: 1) standardized response mean of the raw change scores; 2) Guyatt’s Responsiveness Index; and 3) Global Rating Scales of improvement correlated to a quality of life measure.ResultsContent validity was confirmed with a Cronbach α of 0.92 (95% confidence interval, 0.92-0.95) and absence of floor and ceiling effects. Criterion validity was confirmed using the Western Ontario Rotator Cuff Index as a reference standard (r = 0.87, P < .001). The effect size of distribution-based methods of determining responsiveness was large (0.99-1.09) compared to that of mixed- and anchor-based methods (0.47-0.89). All responsiveness calculations met minimum requirements for acceptable thresholds.ConclusionThe RC-QOL is a valid and responsive measure of health-related quality of life in patients with chronic rotator cuff pathology. The results of this study added to the methodologic quality assessment of the RC-QOL, completing 7 of 10 Consensus-Based Standards for the Selection of Health Measurement Instruments criteria.

Basic Motor Skills of Children With Down Syndrome: Creating a Motor Growth Curve.

To create a motor growth curve based on the Test of Basic Motor Skills for Children with Down Syndrome (BMS) and estimate the age of achieving BMS milestones. A multilevel exponential model was applied to create a motor growth curve based on BMS data from 119 children with Down syndrome (DS) aged 2 months to 5 years. Logistic regression was applied to estimate the 50% probability of achieving BMS milestones. The BMS growth curve had the largest increase during infancy with smaller increases as children approached the predicted maximum score. The age at which children with DS have a 50% probability of achieving the milestone sitting was 22 months, for crawling 25 months, and for walking 38 months. The creation of a BMS growth curve provides a standardization of the gross motor development of children with DS. Physical therapists then may monitor a child's individual progress and improve clinical decisions.

Responsiveness and Seasonal Variation of a 12x25m Swimming Test.

Critical speed (CS) and supra-CS distance capacity (D') are useful metrics for monitoring changes in swimmers' physiological and performance capacities. However, the utility of these metrics across a season has not been systematically evaluated in high level swimmers. Twenty-seven swimmers (18 female; age 19.1 ± 2.9 y, 9 male; 19.5 ± 1.9 y, mean ± SD) completed the 12x25m swimming test multiple times (4 ± 3 tests/swimmer) across a two-year period. Season-best times in all distances for the test stroke were sourced from publicly available databases. Swimmers' distance speciality was determined as the event with the time closest to world record. Four metrics were calculated from the 12x25m test: CS, D', peak speed and drop off %. Guyatt's Responsiveness Index values were calculated to ascertain the practically relevant sensitivity of each 12x25m metric: CS = 1.5, peak speed = 2.3, D' = 2.1 and drop off % = 2.6. These values are modified effect sizes (ES); all are large effects. Bayesian mixed-modelling showed substantial between-subject differences between genders and strokes for each variable, but minimal within-subject changes across the season. Drop off % was lower in 200 m swimmers (14.0 ± 3.3%) compared to 100 m swimmers (18.1 ± 4.1%, p = 0.003, ES = 1.10). The 12x25m test is best suited to differentiating between swimmers of different strokes and events. Further development is needed to improve its utility in quantifying meaningful changes over a season for individual swimmers.

Responsiveness of the EQ-5D-3L and EQ-5D-5L in patients following total hip or knee replacement.

To examine the responsiveness of the EQ-5D-3L and EQ-5D-5L among total hip/knee replacement (THR/TKR) patients. The EQ-5D (3L or 5L) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) have been routinely administered to all THR/TKR patients before and at 3 months after surgery in Alberta, Canada, since 2010. Patients were included in this analysis if they completed the WOMAC and the same version of EQ-5D at baseline and 3-month follow-up. The WOMAC was used as an anchor to categorize patients into 9 subgroups according to the relative change from baseline, i.e., no change, and 4 categories each for the amount of deterioration or improvement: large (≥ 70%), moderate (50% ≤ change < 70%), small but important (20% ≤ change < 50%), and very mild (0 < change ≤ 20%). The responsiveness of the EQ-5D-3L and EQ-5D-5L for each subgroup was assessed using effect size, standardized response mean, and Guyatt's Responsiveness Index. A total of 1594 patients completed the EQ-5D-3L and WOMAC (60% females, mean age 66years, N = 646 [41%] THR), and 3180 completed the EQ-5D-5L and WOMAC (60% females, mean age 66years, N = 1352 [43.2%] THR) at baseline and 3-month follow-up. For both THR and TKR patients with "small but important" improvement, the EQ-5D-5L was consistently more responsive than the EQ-5D-3L. Our study demonstrated that the EQ-5D-5L is more responsive than the EQ-5D-3L in identifying health-related quality of life changes in THR/TKR patients. We recommend using the EQ-5D-5L in longitudinal studies in this patient population.

PRM169 - RESPONSIVENESS OF THE EQ-5D-5L AND EQ-5D-3L IN PATIENTS FOLLOWING TOTAL HIP OR KNEE REPLACEMENT

To examine the responsiveness and estimate minimally important difference (MID) of the EQ-5D-3L and EQ-5D-5L among total hip/knee replacement (THR/TKR) patients. The EQ-5D (3L or 5L) and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) have been routinely administered to all THR/TKR patients before and at 3-month after surgery in Alberta, Canada. Patients were included in this analysis if they completed the WOMAC and the same version of EQ-5D at baseline and 3-month follow-up. The EQ-5D-3L and EQ-5D-5L index scores were derived using the Canadian 3L and 5L value sets, respectively. The WOMAC overall score was transformed into a 0-100 scale (higher better). We used this overall WOMAC score as an anchor and categorized patients into 9 sub-groups according to the relative change from baseline: no change and 4 categories each for amount of deterioration or improvement: large (≥70%), moderate (50%≤change<70%), small but important (20%≤change<50%), and very mild (0<change≤ 20%), The responsiveness of the EQ-5D-3L and EQ-5D-5L for patients in each category was assessed using effect size, standardized response mean, and Guyatt's Responsiveness Index. MID was estimated using the receiver operating characteristic curves. A total of 1,594 patients completed both the 3L version and WOMAC (59.9% females, age 66.2 years, 40.6% THR), and 3,180 patients completed both the 5L version and WOMAC (60.1% females, age 66.1 years, 43.2% THR) at baseline and 3-month follow-up. For patients in the “small but important improvement” group, the EQ-5D-5L was consistently more responsive than the EQ-5D-3L. The MID was estimated as 0.118 (THR) and 0.090 (TKR) for EQ-5D-3L and 0.218 (THR) and 0.105 (TKR) for EQ-5D-5L. Our study demonstrated that the EQ-5D-5L is more responsive than the EQ-5D-3L in identifying changes in health-related quality of life in patients undergoing THR/TKR. We recommend using the EQ-5D-5L in longitudinal studies in this patient population.

Control of Allergic Rhinitis and Asthma Test for Children (CARATKids): Validation in Brazil and cutoff values

BackgroundThe Control of Allergic Rhinitis and Asthma Test for Children (CARATKids) assesses asthma and allergic rhinitis control in children younger than 12 years. ObjectiveTo validate the Brazilian Portuguese version of the CARATKids and to define the cutoff values for identifying uncontrolled disease. MethodsChildren aged 6 to 12 years with asthma and allergic rhinitis were studied (n = 102). CARATKids, childhood Asthma Control Test (cACT), total nasal symptom score (TNSS), and visual analog scale (VAS) scores were obtained at baseline and after 4 to 6 weeks. Internal consistency, test-retest reliability, responsiveness, and validity of the Brazilian CARATKids were assessed according to the Consensus-based Standards for the Selection of Health Measurements Instruments checklist. The minimal clinically important difference (MCID) was evaluated using distribution and anchor methods. Spearman correlations were used to compare CARATKids scores with external measures of control. Receiver operating characteristic curve analysis was performed to establish cutoff values. ResultsFifty children completed both visits. The Cronbach α and intraclass correlation coefficient of CARATKids were 0.81 and 0.85, respectively. The Guyatt responsiveness index was −1.34, and within-patient change in clinically unstable patients (n = 31) was significant (P = .02). As for cross-sectional and longitudinal validity, correlation coefficients ranged from 0.58 to 0.77 (P < .001) and 0.30 to 0.57 (P < .05), respectively. The estimated MCID for CARATKids was 3. The optimal cutoffs (sensitivity and specificity) to exclude uncontrolled and controlled disease were 3 or less (97% and 67%) and 6 or greater (56% and 96%), respectively. ConclusionCARATKids is a reliable and valid tool to assess asthma and allergic rhinitis control in Brazilian children. A score of 6 or higher on CARATKids identifies uncontrolled disease, and a score of 3 or lower excludes poor disease control.

Use of the Control of Allergic Rhinitis and Asthma Test (CARATkids) in children and adolescents: Validation in Dutch.

Allergic rhinitis and asthma are common and closely related diseases. Recently, a Portuguese questionnaire has been developed 'The Control of Allergic Rhinitis and Asthma Test' (CARATkids) that measures disease control of both diseases in children. This study aims to validate the CARATkids in Dutch children and for the first time in adolescents and, in addition, to calculate the minimal clinically important difference (MCID). A prospective observational study was conducted in an outpatient clinic. After translation of the CARATkids from Portuguese to Dutch, patients (6-18 years) with asthma or asthma and allergic rhinitis completed the CARATkids, Asthma Control Test, and visual analog scale questionnaire three times. Baseline characteristics, mean scores, internal consistency, test-retest reliability, cross-sectional and longitudinal validity, discriminative properties, responsiveness, and MCID of the CARATkids were assessed. A total of 111 patients were included. In total, 86% and 79%, respectively, completed the questionnaires at the second and third visits. All children had asthma, and 85% had concomitant allergic rhinitis. The internal consistency was good with all expected a priori correlations met. CARATkids scores were higher in patients with uncontrolled asthma and patients with moderate-severe rhinitis compared to better controlled subjects. Patients with a variable asthma control had significantly higher scores during periods of uncontrolled asthma. Also the Guyatt's responsiveness index was good. The MCID was 2.8. The CARATkids questionnaire is a reliable and valid tool to assess allergic rhinitis and asthma control among Dutch children. The tool can be used in adolescents.

Accuracy of Diffusion-weighted Magnetic Resonance Colonography in Assessing Mucosal Healing and the Treatment Response in Patients with Ulcerative Colitis

Using sigmoidoscopy as the gold standard, we assessed the accuracy, and the responsiveness to change, of diffusion-weighted magnetic resonance colonography in ulcerative colitis, using the Nancy score. A total of 29 ulcerative colitis patients, having undergone at least two diffusion-weighted magnetic resonance colonographies, were included. Disease activity was evaluated using the Mayo endoscopic subscore and the Nancy score. We determined the accuracy of the Nancy score in the diagnosis of mucosal healing. We also assessed its responsiveness to change in 17 patients with a Mayo endoscopic subscore of 2 or 3 at treatment initiation. A total Nancy score < 7 had a sensitivity of 0.75 and a specificity of 0.67 (area under the curve: 0.72; 95% confidence interval: [0.56-0.88]; p = 0.0063) in the diagnosis of mucosal healing. The total Nancy score was sensitive to change in ulcerative colitis [Guyatt's responsiveness index: 1.8; standardised effect size ratio: 1.36]. The Nancy score was reliable [intra-class correlation coefficient: 0.63; p = 0.01]. The mean Mayo endoscopic subscore and the mean Nancy score both fell significantly in patients who achieved mucosal healing (mean ± standard deviation [SD] Mayo endoscopic subscore: 2.4 ± 0.55 at baseline and 0.6 ± 0.55 at reassessment, p = 0.02; mean Nancy score: 18.2 ± 9.1 at baseline and 3 ± 1.6 at reassessment, p = 0.006). No significant changes in Nancy score were observed in active patients at reassessment. The Nancy score is a highly responsive, reliable tool for assessing treatment response in patients with ulcerative colitis. The Nancy score accurately detects mucosal healing.

Clinical Efficacy of Celecoxib Compared to Acetaminophen in Chronic Nonspecific Low Back Pain: Results of a Randomized Controlled Trial.

In this randomized controlled trial, we compared the effect of celecoxib and acetaminophen on pain and magnetic resonance imaging (MRI) scores in patients with chronic nonspecific low back pain. A total of 50 patients with chronic nonspecific low back pain were blindly randomized into 2 groups treated with celecoxib (200 mg twice daily) or acetaminophen (500 mg twice daily). Outcome measures included total back pain, nocturnal back pain, Oswestry Disability Index (ODI) scores, the Short Form 36 health survey to assess physical and mental status, and patient global assessment. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index, and Bath Ankylosing Spondylitis Metrology Index scores were also assessed before and after the therapy. The Spondyloarthritis Research Consortium of Canada scoring method was used to evaluate spinal MRI changes. Celecoxib showed a superior effect on total back pain, ODI, BASDAI, nocturnal back pain, and patient global assessment, compared to acetaminophen (P < 0.05). The number of patients with a significant change in back pain scales was higher in the celecoxib arm (ODI 34.8% versus 4.5%, nocturnal back pain 41.7% versus 9.1%, total back pain 33.3% versus 9.1%, and BASDAI 30.4% versus 9.1%; P < 0.01 for all). The responsiveness to celecoxib, calculated by Guyatt's Responsiveness Index, was 1.62, 1.28, 1.27, and 0.58 for the ODI, total back pain, BASDAI, and nocturnal back pain, respectively. The MRI scores for sacroiliac joints and spine showed no significant change with either treatment when compared with baseline values (P > 0.05). There was superior efficacy of celecoxib compared with acetaminophen in chronic nonspecific low back pain. Inflammatory lesions of sacroiliac joints and spine are commonly seen in nonspecific low back pain, but these lesions did not change with either celecoxib or acetaminophen treatments and were not associated with clinical response to either agent.

Validation of the Mayo Hip Score: construct validity, reliability and responsiveness to change.

BackgroundPrevious 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.MethodsDiscriminant 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.ResultsFive 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).ConclusionsMayo Hip Score is valid, sensitive to change and associated with future risk of revision surgery in patients with primary THA.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-0868-3) contains supplementary material, which is available to authorized users.

Responsiveness of the Chinese versions of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire and Neck Disability Index in postoperative patients with cervical spondylotic myelopathy.

Prospective cohort study. To evaluate the postoperative responsiveness of the Chinese versions of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) and the Neck Disability Index (NDI) in a cohort of patients with cervical spondylotic myelopathy. We have recently completed the translation and cross-cultural adaptation of a Chinese version of JOACMEQ. However, the postoperative responsiveness of the Chinese JOACMEQ and how it compares with the more commonly used NDI remain undetermined. Forty-five patients with cervical spondylotic myelopathy undergoing surgical decompression were recruited. All patients completed the Chinese JOACMEQ and the NDI preoperatively and again at 3-month follow-up together with an 11-point Global Rating of Change scale. Patients were dichotomized either as "Improved" or "Stable" on the basis of Global Rating of Change. Paired t test, standardized effect sizes, and Guyatt responsiveness index were used to determine internal responsiveness. External responsiveness was evaluated by the area under the receiver operating characteristic curve and the minimal clinically important change was determined as the optimal cutoff point for patient discrimination anchor-based on Global Rating of Change classification. Bladder function and quality of life (QOL) domains (P < 0.03) of the JOACMEQ and the NDI (P = 0.004) reached statistically significant difference with the paired t test. After the dichotomization, the standardized effect size was strong for the QOL domain in the improved group (0.85) and the Cervical spine function (0.97) in the stable group, respectively. Based on the Guyatt responsiveness index, strong responsiveness was found for the Bladder function (0.88) and QOL (0.76) domains of the JOACMEQ and moderate responsiveness (0.55) for the NDI. The Bladder function (area = 0.82; minimal clinically important change = 6) and QOL (0.83; minimal clinically important change = 8.5) also produced largest area under the receiver operating characteristic curve. Bladder function and QOL domains of the JOACMEQ seem to demonstrate the strongest postoperative responsiveness and thus may be more appropriate than NDI when attempting to determine treatment efficacy in cervical spondylotic myelopathy. 3.

Responsiveness and sensitivity of the Early Childhood Oral Health Impact Scale to primary dental care for early childhood caries.

This study examined the responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) to dental treatment of early childhood caries (ECC) in a primary dental care setting. Parents of children participating in a randomized controlled trial completed the ECOHIS at baseline and follow-up, and rated the global oral health transition of their child at follow-up ('worsened', 'no change', 'improved'). Change scores were calculated and longitudinal construct validity assessed by examining the association between change scores and global oral health transition groups. ECOHIS changes from baseline to follow-up within global transition groups were also evaluated. Effect sizes, minimally important difference, and Guyatt's responsiveness index were calculated to examine the scale's sensitivity and responsiveness. After 11.3 months, complete questionnaire data were available for 189 participants; 59% reported 'improved' oral health. The follow-up scores were significantly lower in the child psychology, parental distress and family impact section, P < 0.001, and in the child social interaction, family function and the total ECOHIS scores, P < 0.05, Wilcoxon signed-rank test. There was a significant difference in changed scores among the global transition groups, P < 0.05, Kruskal-Wallis test, and the difference was significant between 'worsened' and 'improved' groups for the family impact and the total ECOHIS scores, Dunn test, P < 0.05. Effect sizes were small, 0.17, 0.33, 0.30 for the child impact, family impact and total ECOHIS scores, respectively, for those reporting 'improved' oral health. The responsiveness of the ECOHIS to the treatment of ECC in primary dental care settings was modest, and its use to measure treatment effects in primary care settings requires further investigations.

Validation of Control of Allergic Rhinitis and Asthma Test for Children (CARATKids) – a prospective multicenter study

Control of Allergic Rhinitis and Asthma Test for Children (CARATKids) is the first questionnaire that assesses simultaneously allergic rhinitis and asthma control in children. It was recently developed, but redundancy of questions and its psychometric properties were not assessed. This study aimed to (i) establish the final version of the CARATKids questionnaire and (ii) evaluate its reliability, responsiveness, cross-sectional validity, and longitudinal validity. A prospective observational study was conducted in 11 Portuguese centers. During two visits separated by 6wk, CARATKids, visual analog scale scales and childhood asthma control test were completed, and participant's asthma and rhinitis were evaluated by his/her physician without knowing the questionnaires' results. Data-driven item reduction was conducted, and internal consistency, responsiveness analysis, and associations with external measures of disease status were assessed. Of the 113 children included, 101 completed both visits. After item reduction, the final version of the questionnaire has 13 items, eight to be answered by the child and five by the caregiver. Its Cronbach's alpha was 0.80, the Guyatt's responsiveness index was -1.51, and a significant (p<0.001) within-patient change of CARATKids score in clinical unstable patients was observed. Regarding cross-sectional validity, correlation coefficients of CARATKids with the external measures of control were between 0.45 and -0.69 and met the a priori predictions. In the longitudinal validity assessment, the correlation coefficients between the score changes of CARATKids and those of external measures of control ranged from 0.34 to 0.46. CARATKids showed adequate psychometric properties and is ready to be used in clinical practice.

Longitudinal construct validity and responsiveness of measures of walking capacity in individuals with lumbar spinal stenosis

Background contextWalking capacity is a primary outcome indicator for individuals with lumbar spinal stenosis (LSS). Therefore, there is a demand for psychometrically sound measures of walking that are responsive to change. PurposeThe primary objective of this study was to examine longitudinal construct validity of the Physical Function Scale of the Swiss Spinal Stenosis Questionnaire (PF Scale), the Oswestry Disability Index (ODI), and the walking capacity items from these scales specifically for the assessment of walking capacity in LSS using the objective Self-Paced Walking Test (SPWT) as the external standard. A secondary objective was to examine responsiveness of measures of walking using a self-reported walking capacity change scale as the external criterion standard. Study designPatients were prospectively enrolled. Patient sampleTwenty-six patients were included in this study (17 women and 9 men), with an average age of 68.5 years (SD, 9.2). All participants had LSS diagnosed by a spine specialist surgeon based on both clinical examination and imaging, as well as self-reported walking limitations (neurogenic claudication). Outcome measuresThe self-reported outcome measures included in this study were PF Scale, ODI, and self-reported walking capacity change score. Functional measuresThe functional measure used in the study was SPWT. MethodsLongitudinal construct validity was assessed using the correlational method. Internal responsiveness was examined using Guyatt responsiveness index and external responsiveness using receiver operating characteristic analysis. Change in the SPWT and the self-reported walking capacity change score were used as external criteria for the analysis. ResultsThe highest correlations with change in the SPWT were 0.78 for the ODI walking item and 0.78 for the walking capacity change score. Changes in the PF Scale and ODI score were correlated with change in the criterion SPWT at r=0.56 and r=0.70, respectively. There were no differences observed between the PF Scale and ODI for any of the responsiveness indices. ConclusionsThe PF Scale, ODI, and walking capacity change score are able to detect changes in walking capacity in people with LSS. The individual walking capacity item from the ODI appears to be the most valid and responsive to changes in measured walking and may be a reasonable alternative for measuring walking when an objective test such as the SPWT is not feasible.

Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms

The Overactive Bladder Symptom Score (OABSS) is comprised of 4 items with a single total score for quantification of OAB symptoms and has been reported as sensitive to treatment-related changes. The aim of this study was to assess the psychometric properties of the Korean version in patients with OAB symptoms. Two prospective trials were conducted at two teaching hospitals. The Part I study evaluated the internal consistency and test-retest reliability among 42 enrolled patients, and the Part II trial assessed the construct validity and anticholinergic responsiveness in 50 enrolled patients and 50 controls. Internal consistency was found acceptable, with Cronbach's α of 0.73 for total OABSS score. From a 2-week test-retest, Spearman's rho of each item ranged from 0.53 to 0.82, and the intraclass correlation coefficient of the total score was 0.80, showing the high stability. Acceptable discriminant validity was demonstrated, with substantially different correlations of OABSS scores with an International Prostate Symptom Score-storage and voiding score sum, and significant differences between patients and controls. Convergent validity was acceptable, with moderate correlations between each OABSS item and the corresponding 3-day frequency-volume chart variables. The Korean version was found considerably responsive to symptom changes following 12-week solifenacin treatment, as judged by moderate or large effect sizes, standardized response means, and the Guyatt Responsiveness Index. With good psychometric properties and responsiveness, the Korean version of the OABSS may offer researchers and clinicians a valid and reliable measure for the assessment of OAB symptoms in the Korean population.

Clinical Changes in Older Adults During Hospitalization: Responsiveness of the interRAI Acute Care Instrument

To evaluate the responsiveness of the Minimum Data Set interRAI Acute Care (AC), a comprehensive geriatric assessment system, to detect clinical changes in patient status during hospital stays. An explorative secondary data-analysis comparing prospectively collected data with the interRAI AC before hospitalization, upon admission, and at discharge. Clinicians from multiple disciplines in nine geriatric and eight nongeriatric wards of nine acute hospitals performed the assessment. The interRAI AC was administered serially to 256 geriatric inpatients (aged 83.2 ± 5.2; 60% female). Responsiveness (capacity to detect changes in patients) was calculated for the output scales on five domains: activities of daily living (ADLs), cognition, communication, depressive symptoms, and pain. Internal responsiveness was evaluated using the Friedman test and Guyatt technique. Significant differences in clinical status were found for all five domains, based on the Friedman test. Post hoc tests revealed differences between each assessment period, except for cognition and communication from admission to discharge and for depressive symptoms from before admission to discharge. The Guyatt Responsiveness Index showed good to excellent capacity to detect longitudinal changes during hospitalization for cognition, communication, and pain and substantial performance for ADLs and depressive symptoms. In older inpatients, fluctuations in ADLs, cognition, communication, depressive symptoms, and pain can be captured using the interRAI AC output scales, enabling clinicians to evaluate longitudinal changes from admission to discharge and to provide a comparison with patient status before the acute onset of the illness. These results support the use of these scales in geriatric and nongeriatric wards.

Comparison of Reliability and Responsiveness of Patient-Reported Clinical Outcome Measures in Knee Osteoarthritis Rehabilitation

Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than another when applied to subjects with knee OA. We believe that all 3 instruments are appropriate outcome measures to examine change in functional status of patients with knee OA.

Control of Allergic Rhinitis and Asthma Test (CARAT) can be used to assess individual patients over time

BackgroundThe Control of Allergic Rhinitis and Asthma Test (CARAT10) has been proposed as the first tool to implement the Allergic Rhinitis and its Impact on Asthma initiative guidelines in clinical practice. To serve this purpose, it must have adequate properties to assess the control of an individual over time. This study aimed to prospectively assess the test-retest reliability, responsiveness and longitudinal validity of CARAT10.MethodsAdults with asthma and allergic rhinitis were enrolled at 4 outpatient clinics of Portuguese central hospitals. At each of the two visits, 4 to 6 weeks apart, patients filled out CARAT10 and additional questionnaires, followed by a medical evaluation blinded to the questionnaires’ answers.ResultsFrom the 62 patients included, 51 patients completely filled out CARAT10 at both visits. The test-retest reliability, computed as an intra-class correlation coefficient, was 0.82. Regarding responsiveness, a significant change (p = 0.002) of CARAT10 score in clinically unstable patients was observed (95%CI -5.08; -1.31) and the Guyatt’s responsiveness index was 1.54. As for the longitudinal validity assessment, the correlation coefficients of the changes of CARAT10 scores with those of ACQ5 and symptoms VAS ranged from 0.49 to 0.65, while with the physician assessment of control they ranged from 0.31 to 0.41.ConclusionCARAT10 has good test-retest reliability, responsiveness and longitudinal validity. It can be used to assess control of allergic rhinitis and asthma, both to compare groups in clinical studies and to evaluate individual patients in clinical practice.