Standardized Response Mean Values Research Articles

Minimum clinically important differences in the Minnesota Living with Heart Failure questionnaire: from a study of heart failure patients treated with integrated Chinese and Western medicine

ObjectiveThe purpose of this study was to estimate the minimum clinically important differences (MCIDs) in the Minnesota Living with Heart Failure questionnaire (MLHFQ), which targeted patients with heart failure treated with integrated Chinese and Western medicine, as a means of helping doctors and patients judge the effectiveness of intervention.MethodsA total of 194 patients with chronic heart failure were recruited from three general hospitals in Beijing. Anchor-based and distribution-based approaches were used to estimate MCID. The anchor was SF-36 item 2 (HT, Health Transition), and the calculation methods included the mean change method, receiver operating characteristic (ROC) curve analysis, and linear regression model. For the distribution-based approaches, 0.2, 0.5, and 0.8 standardized response mean (SRM) values and standard error of measurement (SEM) value of 1 were used.ResultsThe correlation coefficients of the MLHFQ scale information and HT were 0.346–0.583. Different MCIDs were obtained by the mean change method, ROC curve, and linear regression model. The minimum MCID in the physical domain, emotional domain, and total scores were 3.6, 2.0, and 7.4, respectively; the maximum estimates were 9.5, 2.5, and 13.0, respectively; and the average estimates were 5.7, 2.2, and 10.0, respectively. The average estimates were close to the result of the 0.5 SRM or 1 SEM.ConclusionWe established MCIDs in the MLHFQ using anchor-based and distribution-based approaches. It was recommended to round the average estimates of anchor-based approaches up to the nearest whole number for the MCIDs of the MLHFQ physical domain, emotional domain, and total scores. The results were 6.0, 2.0, and 10.0, respectively.

Validity of the German Menière's Disease Patient-Oriented Symptom Severity Index

The MD POSI is a disease-specific questionnaire to determine the health-related quality of life (HRQoL) of patients with Menière's disease (MD). Validity and reliability of the German translation of the MD POSI. Prospective data analysis of a patient group with vertigo (n = 162), which was treated in the otorhinolaryngology of a University Hospital from 2005-2019. A clinical selection was made according to the new Bárány classification in a "definite" and "probable" Menière's disease. HRQoL was assessed using the German translation of the MD POSI, the Vertigo Symptom Score (VSS) and the Short Form (SF-36). Reliability was measured by Cronbach's α and test-retesting after 12 months and again 2 weeks later. Content and agreement validity were examined. Cronbach α values greater than 0.9 indicated good internal consistency. There was no statistically significant difference from baseline to 12 months, except for the subscore "during the attack". There were significant positive correlations between the VSS overall/VER/AA and the overall index of the MD POSI and negative significant correlations with the SF-36 domains physical functioning, physical role functioning, social functioning, emotional role functioning, mental well-being. There were low SRM (standardized response mean) values below 0.5. The German translation of the MD POSI is a valid and reliable instrument to evaluate the impact of MD on patients' disease-specific quality of life.

Can the Single Assessment Numeric Evaluation (SANE) be used as a stand-alone outcome instrument in patients undergoing total shoulder arthroplasty?

There is no consensus as to which patient-determined shoulder outcome scores should be considered when analyzing patient outcomes for either clinical or research purposes. Use of multiple patient-determined outcomes may be redundant and cause increased responder burden. To date, the Single Assessment Numeric Evaluation (SANE) has not been widely accepted as a stand-alone shoulder-specific outcome measure. The hypothesis of this study was that the SANE would correlate with and be equal or superior in responsiveness to other outcome measures that have been used in a stand-alone fashion in patients undergoing total shoulder arthroplasty (American Shoulder and Elbow Surgeons [ASES], Western Ontario Osteoarthritis of the Shoulder [WOOS], and Simple Shoulder Test [SST] scores). In addition, it was hypothesized that the SANE would be more relevant to each patient than the ASES assessment, further supporting the use of the SANE as a stand-alone shoulder-specific outcome measure. A retrospective review of a database of patients undergoing total shoulder arthroplasty was performed, in which the SANE score was recorded simultaneously with the ASES, WOOS, and/or SST score. Correlations were determined using the Pearson coefficient. Subgroup analysis was performed to determine whether correlations differed in (1) preoperative outcome and (2) postoperative outcome determinations. Responsiveness was determined by calculating the standardized response mean and the effect size of all scores.The relevance of the SANE and ASES assessments was examined using the scores of 150 consecutive patients to determine the number of questions on each assessment that were not answered. Correlation was excellent for the SANE score and the ASES score (n=1447, r=0.82, P<.0001), WOOS score (n=1514, r=0.83, P<.0001), and SST score (n=1095, r=0.81, P<.0001). The correlation of preoperative scores was moderate and that of postoperative scores was strong-moderate when the SANE score was compared with all 3 other scores. All scores were highly responsive, with standardized response mean values of 2.2 for the SANE score, 2.3 for the ASES score, 1.4 for the WOOS score, and 1.6 for the SST score. The effect size of the SANE score was 2.9; ASES score, 2.9; WOOS score, 2.9; and SST score, 2.3. One hundred percent of the SANE questions were answered completely compared with 61% of the ASES questions (P<.0001). In patients undergoing total shoulder arthroplasty, the SANE score highly correlated with the WOOS, ASES, and SST scores, which have been used as stand-alone shoulder-specific outcome measures. The SANE score may provide the same information as the WOOS, ASES, and SST score regarding outcomes with a significant reduction in responder burden. It is logical that the SANE can be used as a stand-alone instrument for patients undergoing total shoulder arthroplasty.

The patient-rated wrist and hand evaluation was successfully translated to the Slovenian language

BackgroundThe Patient-Rated Wrist and Hand Evaluation (PRWHE) is one of the widely used PROMs in the hand rehabilitation. PurposeTo develop the Slovenian version of the PRWHE (PRWHE-Slo) and to evaluate its psychometric properties. Study designA single-centre observational prospective cohort study. MethodsFifty patients with distal radius fracture (DRF) were enrolled in the study. Construct validity was assessed by examining the correlations between the PRWHE-Slo and QuickDASH, EQ-5D-5L, wrist ROM, and grip strength. Reliability was evaluated by determining internal consistency (Cronbach...s alpha) and test-retest reliability (intraclass correlation coefficient (ICC)). The standard error of measurement (SEM) and the minimal detectable change (MDC) were determined. The responsiveness of the PRWHE-Slo was assessed with the effect size (ES) and standardised response mean (SRM). ResultsThe Cronbach’s alpha value of 0.96 and the ICC (95% CI) value of 0.95 showed excellent internal consistency and reliability for the total PRWHE-Slo score. When assessing construct validity of PRWHE-Slo, there was a strong positive correlation between all subscales and total scores of the PRWHE-Slo and the QuickDASH (r-values ranging from 0.72 to 0.83). The unrelated dimensions such as the function subscale of the PRWHE and the mobility and anxiety/depression subscales of the EQ-5D-5L were not statistically significantly correlated. Grip strength was moderately negatively correlated with all PRWHE subscales, whereas ROM showed no statistically significant correlations with any of the PRWHE-Slo subscales. SEM and MDC for the total PRWHE-Slo score were 5.40 and 14.97, respectively. The PRWHE-Slo proved to be highly responsive in DRF patients with SRM and ES values of 1.27 and 0.91, respectively. ConclusionsThe psychometric analysis of this study shows the PRWHE-Slo to be reliable, valid, and responsive PROM for assessing pain and disability in patients after DRF.

Development and performance of the Clinical Trials ESSDAI (ClinTrialsESSDAI), consisting of frequently active clinical domains, in two randomised controlled trials in primary Sjögren's syndrome.

To develop and evaluate the Clinical Trials EULAR Sjögren's Syndrome Disease Activity Index (ClinTrialsESSDAI), consisting of frequently active clinical domains of the ESSDAI, using two randomised controlled trials in primary Sjögren's syndrome (pSS). The ASAP-III trial in abatacept (80 pSS patients) and TRACTISS trial in rituximab (133 pSS patients) were analysed. The most frequently active clinical domains were selected, and ClinTrialsESSDAI total score was calculated using existing weightings of the ClinESSDAI (which also excludes the biological domain). Performance of the ClinTrialsESSDAI was compared to ClinESSDAI and ESSDAI. Responsiveness was assessed using standardised response mean (SRM), and discrimination was assessed using adjusted mean difference. Besides the biological domain, the most frequently active domains were glandular, articular, haematological, constitutional, lymphadenopathy and cutaneous. These domains were selected for the ClinTrialsESSDAI. At primary endpoint visits, SRM values of ClinTrialsESSDAI, ClinESSDAI and ESSDAI were respectively -0.65/-0.59, -0.63/-0.59 and -0.64/-0.61 for abatacept/placebo and -0.33/-0.13, -0.34/-0.12 and -0.41/-0.16 for rituximab/placebo. Adjusted mean differences between active treatment and placebo groups were respectively -1.7, -1.4 and -1.1 for ASAP-III and -1.1, -1.1 and -1.2 for TRACTISS. The ClinTrialsESSDAI, consisting of six frequently active clinical domains of the ESSDAI, shows closely similar responsiveness and discrimination between treatment groups compared to the ClinESSDAI and ESSDAI. Therefore, this ClinTrialsESSDAI is not preferable to ClinESSDAI and ESSDAI for use as primary endpoint. A composite endpoint combining response at multiple clinically relevant items seems more suitable as primary study endpoint in pSS.

Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review.

A higher level of pain self-efficacy has been suggested as a predictor of a better outcome in patients with musculoskeletal disorders. The Pain Self-Efficacy Questionnaire (PSEQ) is one of the most frequently used patient-reported outcome measures for pain self-efficacy. The purpose of this study was to conduct a systematic review that would identify, appraise, and synthetize the psychometric properties of the PSEQ. Embase, MEDLINE, and CINAHL databases were searched for publications reporting on psychometric properties of the PSEQ in populations with musculoskeletal disorders. After applying selection criteria on identified citations, 28 studies (9853 participants) were included. The methodological quality as measured with the COSMIN risk of bias tool varied from adequate to very good for most measurement properties. The results showed a weighted mean intraclass correlation coefficient of 0.86 (range: 0.75-0.93) for test-retest reliability for the original 10-item PSEQ and the minimal detectable change at 95% confidence interval was 11.52 out of 60 points. Effect size and standardized response mean values were 0.53 and 0.63, respectively, whereas the minimal clinically important difference ranged from 5.5 to 8.5 in patients with chronic low back pain. Internal consistency (Cronbach alpha) ranged from 0.79 to 0.95. The results also showed that the PSEQ has low to moderate correlations with measures of quality of life, disability, pain, pain interference, anxiety, depression, and catastrophizing. Finally, the PSEQ has been adapted and validated in 14 languages. Overall, the results demonstrate that the PSEQ has excellent validity, reliability, and responsiveness. Further high-quality studies are needed to determine responsiveness in populations other than chronic low back pain.

Sensitivity to Change and Responsiveness of the Original and the Shortened Version of the Community Balance and Mobility Scale for Young Seniors

ObjectiveTo examine sensitivity to change and responsiveness of the Community Balance and Mobility Scale (CBM) and shortened CBM (s-CBM). DesignSecondary analysis using data of a randomized controlled trial. SettingGeneral community. ParticipantsYoung community-dwelling seniors aged 61-70 years (N=134; mean age, 66.2±2.5y). InterventionsParticipants underwent 12 months of exercise intervention. Main Outcome MeasuresCBM and s-CBM. Sensitivity to change was assessed using standardized response mean (SRM) and paired t tests as appropriate. Responsiveness was assessed using 2 minimal important difference (MID) estimates. Analyses were conducted for the full sample and for the subgroups “high-balance” and “low-balance,” divided by median split. ResultsInferential statistics revealed a significant CBM (P<.001) and s-CBM (P<.001) improvement within the full sample and the subgroups (high-balance: P=.001, P=.019; low-balance: P<.001, P<.001). CBM and s-CBM were moderately sensitive to change (SRM, 0.48 vs 0.38) within the full sample. In the high-balance subgroup, moderate SRM values (0.70) were found for the CBM and small values for the s-CBM (0.29). In the low-balance subgroup, moderate SRM values were found for the CBM (0.67) and high values for the s-CBM (0.80). For the full sample, CBM and s-CBM exceeded the lower but not the higher MID value. In the high-balance subgroup, the CBM exceeded both MID values, but the s-CBM exceeded only the lower. In the low-balance subgroup, CBM and s-CBM exceeded both MID values. ConclusionsThe CBM is a suitable tool to detect intervention-related changes of balance and mobility in young, high-performing seniors. Both versions of the CBM scale show good sensitivity to change and responsiveness, particularly in young seniors with low balance.

Patient-Reported Outcome Measures and Health-Related Quality-of-Life Scores of Patients Undergoing Anatomic Total Shoulder Arthroplasty.

Health-related quality-of-life (HRQoL) scores are required for cost-effectiveness and health-care value analysis. We evaluated HRQoL scores and patient-reported outcome measures (PROMs) in patients with advanced glenohumeral osteoarthritis treated with anatomic total shoulder arthroplasty to establish values of HRQoL scores that can be used for cost-effectiveness and value analysis and to assess relationships between HRQoL scores and shoulder and upper-extremity PROMs. We analyzed 143 patients (143 shoulders) with glenohumeral osteoarthritis treated with anatomic total shoulder arthroplasty; 92 patients had 1-year follow-up. Preoperative and postoperative functional outcomes were assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) score, the American Shoulder and Elbow Surgeons (ASES) score, the Simple Shoulder Test (SST), and a visual analog scale (VAS) for shoulder pain and function. Health utility was assessed with the EuroQol-5 Dimensions (EQ-5D), Short Form-6 Dimensions (SF-6D), and VAS Quality of Life (VAS QoL). HRQoL score validity was determined through correlations between the PROMs and HRQoL scores. The responsiveness of HRQoL scores was measured through the effect size and the standardized response mean. There were significant improvements in all PROMs and HRQoL scores (p < 0.001) at 1 year after the surgical procedure. The changes in VAS QoL (very weak to moderate), EQ-5D (weak), and SF-6D (weak) were significantly correlated (p < 0.05) with the changes in PROMs, demonstrating comparably acceptable validity. There were large effect sizes in the VAS QoL (1.843), EQ-5D (1.186), and SF-6D (1.084) and large standardized response mean values in the VAS QoL (1.622), EQ-5D (1.230), and SF-6D (1.083), demonstrating responsiveness. The effect sizes of all PROMs were larger than those of the HRQoL scores. PROMs and HRQoL scores are not interchangeable, and studies of the cost-effectiveness and value of shoulder arthroplasty should incorporate both shoulder and upper-extremity PROMs and HRQoL scores. The findings of this study provide data on HRQoL scores that are specific to the treatment of advanced glenohumeral osteoarthritis with anatomic total shoulder arthroplasty and can be used for future cost-effectiveness and value analysis studies. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Responsiveness of Device-Based and Self-Report Measures of Physical Activity to Detect Behavior Change in Men Taking Part in the Football Fans in Training (FFIT) Program.

The capacity of physical activity (PA) measures to detect changes in PA within interventions is crucial. This is the first study to examine the responsiveness of activPAL3™ and the International Physical Activity Questionnaire (IPAQ; Short Form) in detecting PA change during a 12-week group-based, men-only weight management program-Football Fans in Training (FFIT). Participants wore an activPAL3™ and completed the IPAQ pre- and post-program (n = 30). Relationships between change scores were assessed by Spearman's correlations. Mean or median changes in PA were measured using paired samples t-tests and Wilcoxon signed-rank tests. Responsiveness to change was assessed utilizing Standardized Response Mean (SRM). Both device-based and self-report measures demonstrated significant changes pre-post intervention, although these changes were not significantly correlated. The SRM values for changes in activPAL3™ metrics were: 0.54 (MET-mins/day); 0.53 (step counts/day); and 0.44 (MVPA/day), indicating a small to medium responsiveness to change. SRM values for changes in IPAQ scores were: 0.59 (for total PA mins/day); 0.54 (for total MET-mins/day); 0.59 (for walking MET-mins/day); 0.38 (for vigorous MET-mins/day); and 0.38 (for moderate MET-mins/day), revealing a small to medium responsiveness to change. These findings reveal that two commonly used device-based and self-report measures demonstrated responsiveness to changes in PA. While inclusion of both device-based and self-report measures is desirable within interventions it is not always feasible. The results from this study support that self-reported measures can detect PA change within behavioral interventions, although may have a tendency to overestimate changes compared with device-based measures on absolute values, but not standardized response values.

Substantial clinical benefit, responsiveness, and sensitivity to change of three common outcome measures following shoulder arthroplasty.

Objectives:It is important for clinicians involved in the care of patients with advanced glenohumeral osteoarthritis to determine clinically significant change when using outcome measures. There is little information on the amount of substantial clinical benefit in shoulder outcomes after shoulder arthroplasty. The purpose of this study was twofold: (1) to quantify substantial clinical benefit for the American Shoulder and Elbow Surgery score, the Constant Murley Score, and the Western Ontario Osteoarthritis of the Shoulder index and (2) to provide estimates of responsiveness and sensitivity to change for these measures following shoulder arthroplasty.Methods:The study involved a secondary analysis of previously collected data. The substantial clinical benefit and responsiveness of the measures were calculated based on external anchors related to change in pain, range of motion, and ability to carry out activities of daily living. The areas under curve and standardized response mean represented responsiveness and sensitivity to change.Results:The data of 159 and 131 patients with complete follow-up at 6 months and 2 years were reviewed. The amount of substantial clinical benefit was dependent on the outcome measure and the external anchor and increased for all measures from 6 months to 2 years. Responsiveness was high (areas under curve > 0.80) at 6 months and further improved at 2 years (areas under curve > 0.88). The standardized response mean values of both time points were over 2.00, indicating high effect sizes. The standardized response means of the Constant Murley Score were statistically significantly higher than the standardized response means of the American Shoulder and Elbow Surgery and Western Ontario Osteoarthritis of the Shoulder.Conclusion:Amount of substantial clinical improvement in pain, range of motion, and activities of daily living following shoulder arthroplasty depends on the type of outcome measure used. All three measures, the American Shoulder and Elbow Surgery, absolute and relative Constant Murley Score, and Western Ontario Osteoarthritis of the Shoulder, demonstrated good to excellent accuracy and optimal standardized response means.Level of evidence:Level III, Retrospective Cohort study

Validation of a novel blinding method for measuring postoperative knee articular cartilage using magnetic resonance imaging

To test PEEK implant-associated MRI artifacts, a method for blinding MRI readers, the repeatability of cartilage thickness measures before and 6weeks after high tibial osteotomy (HTO), and the sensitivity to change of cartilage thickness 12months after HTO. Ten patients underwent HTO using a PEEK implant and 3T-MRI before, 6weeks and 12months after surgery. Masks were applied to hide implant visibility on 48 MRI pairs, which were assessed by 7 readers (blinded to time). One blinded reader measured femorotibial cartilage thickness from masked MRIs. No artifacts were produced. Readers were unable to identify scans by time greater than by chance. Cartilage thickness before and 6weeks after surgery was not significantly different and indicated excellent repeatability. Medial cartilage thickness increases 12M postoperatively approached statistical significance (p=0.06), with no lateral changes observed. Half of the participants had an increase in medial cartilage thickness at 12M that exceeded the minimal detectable change. Standardized response mean values were moderate-to-large. Postoperative measures of cartilage thickness are repeatable, consistent and sensitive to change when artifact is eliminated, and a validated blinding technique is used. These results provide proof of concept for accurately measuring increases in medial knee articular cartilage after medial opening wedge HTO.

Whole-Body Reactive Agility Asymmetries among Athletes with Concussion History Are Modifiable

PURPOSE: This study assessed whole-body reactive agility adaptations produced by upper extremity training that imposed simultaneous cognitive and visuomotor demands. METHODS: A cohort of 20 elite athletes representing 6 different Olympic sports (12 males: 25.1 ±5.5 years; 8 females: 27.0 ±4.0 years) performed an upper extremity choice reaction time (RT) test, along with 2 tests of whole-body reactive agility (WBRA) that provided measures of RT, speed, acceleration, and deceleration. The upper extremity test used an Eriksen flanker display (10 congruent and 10 incongruent 5-arrow sets) to designate correct responses for manual deactivation of illuminated buttons on opposite sides of the board. Tests of WBRA required lateral movement responses to 20 left or right visual targets and diagonal movement responses to 16 visual targets presented in right/left and forward/back combinations. One-minute training sessions were completed 2 or 3 times per week over a 3-week period, which involved upper extremity button deactivations and verbal responses to indicate center arrow direction for 20 5-arrow displays. Post-training assessment included the same tests administered prior to training. RESULTS: Each of the athletes completed at least 6 training sessions (7.7 ±0.6). Concussion history was reported by 10 athletes (5.6 ±5.2 years prior to testing; range: 0.3 - 16.5 years), which was significantly associated (1-Sided P < .05) with pre-training measures of WBRA asymmetries for backward diagonal deceleration ≥ .24 (OR=14.3 [estimated by adding 0.5 to each cell]; PPV=100%; NPV=63%), lateral acceleration ≥ .12 (OR=5.4; PPV=70%; NPV=70%), backward diagonal acceleration ≥ .10 (OR=6.0; PPV=67%; NPV=75%), and lateral RT ≥ .16 (OR=13.5; PPV=695%; NPV=86%). Among the 12 athletes with self-reported concussion history, the pre- to post-training standardized response mean (SRM) values for the 4 WBRA asymmetries were .22, 45, .32, and .52, respectively. Visuomotor correct choice RT average difference between incongruent and congruent responses improved from 114 ±46 ms to 59 ±80 ms (SRM=.54). CONCLUSION: Asymmetry in reactive responses could be a manifestation of dysfunctional interhemispheric brain connectivity. Our findings suggest that asymmetries can be reduced through dual-task cognitive-visuomotor training.

The Cerebral Palsy Profile of Health and Function: Upper-Extremity Domain’s Sensitivity to Change Following Musculoskeletal Surgery

The Cerebral Palsy Profile of Health and Function (CP-PRO) Computerized Adaptive Tests (CAT) are quality of life measures developed specifically for use in children with cerebral palsy. This study examined the ability of the upper-extremity (UE) CP-PRO CAT to detect change in function after UE surgery compared with the Pediatric Outcomes Data Collection Instrument (PODCI), ABILHAND-Kids, and Box and Blocks test. From 2009 to 2013, children with cerebral palsy who had UE musculoskeletal surgery completed the UE CP-PRO CAT, PODCI-UE, ABILHAND-Kids, and Box and Blocks tests before surgery (97 children) and at 3 postoperative intervals: 6 months (80 children), 12 months (73 children), and 24 months (52 children). Mean, SD, effect size (ES), and standardized response mean (SRM) values for each measure at each time interval and each level of the Manual Ability Classification System were calculated and compared. Finally, the minimal detectable change at the 90% confidence level was determined. Values for the ES (0.40) and SRM (0.53) for the UE CP-PRO CAT at baseline to 6months were moderate and significantly greater than the PODCI-UE (ES, 0.18; SRM, 0.25). The ES and SRM for the PODCI-UE, ABILHAND-Kids, and Box and Blocks tests were not significantly greater than for the UE CP-PRO CAT at any period. From baseline to 6 months, the UE CP-PRO CAT detected a large and significant improvement for Manual Ability Classification System level II (SRM, 0.70; ES, 0.70). The minimal detectable change for the UE CP-PRO CAT was 5.20. The UE CP-PRO CAT is significantly better in detecting change in UE function inthe first 6 months after surgery and is comparable to other measures at 12 and 24 months. Diagnostic II.

PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology.

This study assessed the responsiveness to change over time and theorized associations of Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures in children and adolescents in treatment for cancer to determine measure readiness for use in cancer clinical trials. We administered eight PROMIS (three symptom, two psychological, and three performance) pediatric short-form measures and the Symptom Distress Scale (SDS) to 96 pediatric oncology patients at three time points during a course of chemotherapy. We assessed responsiveness using paired t tests and generalized estimating equation (GEE) models, calculated standardized response mean (SRM) values for PROMIS measures, and examined scores over three data points (T1-T3). Guided by the theory of unpleasant symptoms (TOUS), we examined associations among the PROMIS measures, the SDS, and other variables using GEE. The paired t tests showed statistically significant changes in two psychological measures and one performance measure from T1 to T2; three symptom, two psychological and two performance measures from T2 to T3; and three symptom and two psychological measures from T1 to T3. Findings from GEE models indicate PROMIS pediatric measures had statistically significant short-term and long-term changes, controlling for demographic and clinical variables. One performance measure did not achieve significant change at any time point. We found positive support for theorized relationships in the TOUS. Most of the PROMIS pediatric measures demonstrated changes over time and had significant relationships as theorized, thus supporting concurrent and construct validity of these measures when administered to pediatric oncology patients during a course of chemotherapy. This evidence supports the measures' readiness for use in clinical trials.

Comparison of the Michigan Hand Outcomes Questionnaire, Boston Carpal Tunnel Questionnaire, and PROMIS Instruments in Carpal Tunnel Syndrome

Patient-reported outcomes are important to assess improvement after surgery. Commoninstruments for carpal tunnel syndrome include the Michigan Hand Outcomes Questionnaire (MHQ) and Boston Carpal Tunnel Questionnaire (CTQ). The Patient-Reported Outcomes Measurement Information System (PROMIS) are newer measures. We evaluated how the PROMIS Pain Interference (PI) and Upper Extremity (UE) scores change after carpal tunnel release. All adult patients with carpal tunnel syndrome treated surgically were asked to participate in this prospective study. PROMIS instruments, MHQ, and CTQ were completed by 101 patients. Estimated means and standard errors were calculated, and piecewise linear fixed effects regression models were applied to the data. Standardized response means were calculated for each outcome measure. The MHQ Total Score did not show a considerable change from the preoperative to 1-week postoperative visit but improved from the 1-week to 3-month postoperative visit (55 to 80). The CTQ Functional Status Score (FSS) worsened from 2.3 preoperatively to 2.6 at the 1-week postoperative visit before improving through the 3-month postoperative visit (1.6). PROMIS UE showed responsiveness similar to the CTQ FSS with a decline at the 1-week visit, 38 to 33, followed by improvement (45 at 3 mo). However, the standardized response mean values were greater for the CTQ FSS compared with PROMIS UE. The average administration time was shortest for PROMIS UE. The CTQ Symptom Severity Scale and MHQ Pain Scores showed improvements as early as the 1-week visit. The CTQ Symptom Severity Scale improved from 3.1 to 2.3, and MHQ Pain Scores improved from 55 to 46. PROMIS PI did not change at the 1-week visit but improved at 6 weeks and 3 months, from 56 to 52 and 49. The standardized response means for PROMIS PI achieved a large effect size only at 3 months. The CTQ FSS is more responsive than PROMIS UE and the MHQ, with the CTQ FSS showing the largest effect sizes. PROMIS PI does not show the responsiveness seen in the CTQ Symptom Severity Scale and MHQ Pain Score. PROMIS instruments require less time to complete. This study demonstrates the change in PROMIS scores after carpal tunnel release and how they compare with legacy outcome instruments.

Validation of Quality of Life Instruments for Cancer Patients \u2013 Colorectal Cancer (QLICP-CR) in patients with colorectal cancer in Northeast China

BackgroundMeasuring quality of life is important for cancer patients, but there are regional differences in age-standardized colorectal cancer incidence and mortality rates which may affect measurement. This study aimed to evaluate the reliability, validity and responsiveness of Quality of Life Instruments for Cancer Patients – Colorectal Cancer (QLICP-CR) in colorectal cancer patients in Northeast China, and assess its usefulness for evaluation of quality of life in these patients.MethodsFrom November 2016 to January 2017, 152 patients with colorectal cancer from Liaoning Cancer Hospital & Institute were surveyed three times using QLICP-CR and the Functional Assessment of Cancer Therapy – Colorectal (FACT-C) to measure their quality of life (on admission, 2–3 days later and at discharge). Reliability was evaluated by internal consistency and test–retest reliability. Validity was examined by item–domain correlation, criterion-related validity and factor construct validity analysis. Responsiveness was assessed using paired Student’s t tests and calculating standardized response mean.ResultsCronbach’s α coefficient for QLICP-CR ranged from 0.62 to 0.93. Pearson correlation and intra-class correlation coefficients for QLICP-GM, the five domains and the total scale of QLICP-CR ranged from 0.74 to 0.91 and 0.74 to 0.90. The item–domain correlation analysis showed good convergent validity and discriminant validity. Correlation analysis of domain scores between FACT-C and QLICP-CR showed good criterion-related validity. Exploratory factor analysis revealed that nine and three principal components were extracted from items in the two modules of QLICP-CR, and the contribution rate of cumulative variance was 70.21 and 72.26%. There were significant differences in quality of life between the first and the third measurements, with standardized response mean values ranging from 0.30 to 0.81.ConclusionsThe QLICP-CR was a reliable, valid and sensitive instrument to measure quality of life in colorectal cancer patients in Northeast China.

Translation, cross-cultural adaptation, and psychometric properties of the Hausa version of the Fear-Avoidance Beliefs Questionnaire in patients with low back pain.

Background and aims The Fear-Avoidance Beliefs Questionnaire (FABQ) is the most widely used self-reported measure of fear-avoidance beliefs about work and physical activity in low back pain (LBP). However, there is no Hausa version for use in patients with LBP. This study aimed to translate, cross-culturally adapt, and test the psychometric properties of the Hausa version of the FABQ in patients with LBP. Methods The Hausa form of FABQ was developed using a forward-backward translation procedure according to recommended guidelines. The pre-final version of the questionnaire was pre-tested on 10 patients with acute LBP and 10 patients with chronic LBP. Psychometric testing was performed in 70 patients with acute LBP and 130 patients with chronic LBP. Reliability was assessed using internal consistency (Cronbach α) and test-retest reliability through intraclass correlation coefficient (ICC). Construct validity was assessed by exploratory factor analysis and divergent validity (Spearman rank correlation coefficient). Responsiveness was also investigated on 40 patients with chronic LBP. Results The Hausa version of the FABQ was successfully translated and proved to be well-understood. The internal consistency was adequate for the questionnaire (0.773) and its physical activity (0.816) and work (0.606) subscales. Test-retest reliability was excellent with an ICC value of 0.928 for the questionnaire and values of 0.901 and 0.863 for the physical activity and work subscales, respectively. Exploratory factor analysis yielded a three-factor structure in both acute and chronic LBP samples explaining 66.4% and 58.6% of the total variance, respectively. The first factor represents fear-avoidance beliefs due to work, the second factor represents fear-avoidance beliefs due to physical activity whereas the third factor represents the fear that pain aggravates due to work. Divergent validity showed moderate to weak correlation between the questionnaire and pain intensity (r=0.502), disability (r=0.415), lumbopelvic motion (r=0.00). The physical activity and work subscales weakly correlated (r=0.280). The effect size and standardized response mean were moderate to small with the work subscale having the lowest effect size (0.34) and standardized response mean (0.34) values. The MDC of the questionnaire was 5.4 points. The questionnaire had no ceiling or floor effects. Conclusions The FABQ was successfully translated into Hausa and cross-culturally adapted with acceptable psychometric properties similar to those of existing versions. The results suggest that the Hausa FABQ can be used to evaluate fear-avoidance beliefs about LBP in Hausa-speaking population for both clinical and research purposes.

Validity and responsiveness of the Nottingham clavicle score in clavicle shaft fractures treated with titanium elastic nailing

BackgroundThe Nottingham Clavicle Score (NCS) has been recently described for functional outcome assessment after injuries to clavicle and the Acromioclavicular joint. However; validity and responsiveness are context specific psychometric terms and the NCS has not been previously described in surgically treated clavicle shaft fractures. Aim of the present study was to investigate validity and responsiveness of the NCS in clavicle fractures treated with titanium flexible nailing. MethodsThis prospective study was undertaken on consecutively operated clavicle shaft fractures treated with titanium elastic nail from November 2013 to August 2016. Functional assessment using NCS was done at two and six months postoperatively. Construct validity was also evaluated by formulating the null hypothesis that there would be no difference in NCS at six months after open and closed reduction and in 15B1 and 15B2 fracture sub-types. The above two hypotheses were formulated based on previous studies that used Constant score and DASH score. Pre-specified hypothesis and results in accordance with the hypotheses suggest satisfactory construct validity. Responsiveness was evaluated using standardized response mean (SRM) and Effect size (ES). ES and SRM values ≥0.80 suggest satisfactory responsiveness. The proportion of patients having the least possible score of 0 points (floor effect) and the highest possible score of 100 points (ceiling effect) was evaluated at two and six months postoperatively. Floor and ceiling effect of <15% suggests satisfactory internal validity. ResultsThirty six consecutively operated patients were included in the study. The NCS at two months and six months was 69.6 ± 9.6 and 87.2 ± 7.1 respectively. The NCS at six months after fixation was 88.7 ± 4.8 in closed reduction cohort and 84.7 ± 9.4 in the open reduction cohort and this difference was not significant (p = 0.1). The NCS at six months after fixation was 85.3 ± 8.3 in 15B1 clavicular fractures and 89.7 ± 4.0 in 15B2 clavicular shaft fractures and this difference was also not significant (p = 0.07). All results pertaining to construct validity were in accordance with our hypothesis thereby suggesting that NCS demonstrates satisfactory construct validity. The ES and SRM were 1.8 and 2.6 respectively. NCS showed no ceiling (0%) or floor effect (0%) at two and six months postoperatively thereby suggesting adequate internal validity of the NCS. ConclusionNCS has satisfactory construct validity, internal validity and responsiveness in surgically treated clavicle shaft fractures with titanium elastic nailing.

Is the modified Harris hip score valid and responsive instrument for outcome assessment in the Indian population with pertrochanteric fractures?

IntroductionThe original Harris hip score (HHS) does not contain ability to perform squatting and sitting cross legged as items in the questionnaire and hence a need was felt to modify the Harris hip score so that it could stay relevant in functional assessment of Indian patients in the rural setting. Validity, responsiveness and ceiling floor effect of the Harris hip score after internal fixation of pertrochanteric fracture has not been previously described. The objective of the study was to investigate construct validity, responsiveness and ceiling floor effects of the modified Harris hip score (mHHS). MethodsFor evaluation of construct validity two hypotheses were formulated: first, there would be no difference in mHHS in cohort of patients treated with short or long proximal femoral nail and second, patients younger than 65 years will have higher mHHS compared to patients older than 65 years postoperatively. Proportion of patients obtaining lowest score of 0 point (floor effect) and those obtaining highest score of 100 points (ceiling effect) was evaluated at one, three and six months postoperatively. It is recommended that the proportion of ceiling and floor effect should be lower than 15% in order to deduce satisfactory internal and content validity of an outcome instrument. Responsiveness was evaluated using distribution based methods (effect size and standardised response mean) and anchor based method (area under the curve using receiver operating curve). Ability to perform cross leg sitting and squatting at six months postoperatively were chosen as two different external anchors. Effect size and standardised response mean values higher than 0.80 and area under the curve value higher than 0.70 are indicators of adequate responsiveness of an outcome instrument. ResultsEighty one consecutive patients with pertrochanteric hip fractures and treated with long and short proximal femoral nail were included in this prospective observational study. Six patients were lost to follow-up due to mortality and complete functional outcome data was available in 75 patients (92.6%). The mean age was 68 years (range: 38–89 years). The mHHS at one, three and six months postoperatively was 39.9 ± 9.5, 61.6 ± 14.7 and 81.0 ± 15.9 respectively. The improvement in mHHS was significant at all time intervals. In accordance with the hypothesis, there was no significant difference in mHHS at one, three and six months postoperatively in patients treated with short or long proximal femoral nail. In accordance with the hypothesis, patients younger than 65 years had significantly better mHHS at one, three and six months postoperatively as compared to patients older than 65 years. There were no floor or ceiling effects at one, three and six months postoperatively. mHHS showed adequate internal responsiveness (Effect size = 4.34; standardised response mean = 4.26) and adequate external responsiveness (Area under curve = 0.77 and 0.89) using different external anchors. ConclusionThe mHHS has adequate construct validity, internal validity and responsiveness to evaluate functional outcome of intramedullary nail fixation in pertrochanteric hip fractures in the Indian population.

Sensitivity and responsiveness to change for the Brazilian version of the child perceptions questionnaire for 8- to 10-year-old children

This study aimed to investigate the sensitivity and responsiveness to change for the Brazilian version of the Child Perceptions Questionnaire (CPQ8–10) after dental caries treatment. Thirty children aged 8 to 10 years old with untreated dental caries were randomly selected from public schools. They responded to the CPQ8–10 before and 1 month after finishing treatment for dental caries. Sensitivity was assessed by determining distribution changes using paired t-tests and Wilcoxon signed-rank tests. Responsiveness to change was evaluated by effect size (ES) and standardized response mean (SRM). Minimally important differences (MIDs) were also evaluated. Mean/median pre-treatment values for the total CPQ8–10 score and subscales were significantly higher than the post-treatment values (p < 0.05). ES was large (effect size ≥ 0.8) for the total CPQ8–10 score and oral symptoms (OS), functional limitations (FL) and emotional wellbeing (EW) subscales and moderate (effect size 0.3–0.7) for the social wellbeing (SW) subscale. SRM values were moderate (0.3–0.7) for the total CPQ8–10 score and FL, EW and SW subscales and high (≥ 0.8) for the OS subscale. MID values for the total CPQ8–10 score and all subscales were lower than the mean score change. The Brazilian version of the CPQ8–10 is sensitive and responsive enough to detect changes brought about by dental caries treatment.