Standardized Response Mean Research Articles

Cross-cultural adaptation of the Victorian institute of sports assessment - Hamstrings (VISA-H) questionnaire for Spanish speaking athletes with proximal hamstring tendinopathy

ObjectiveTo cross-culturally adapt and validate the Victorian Institute of Sports Assessment – Hamstrings (VISA-H) scale into Spanish. DesignClinical measurement study (psychometric analysis). SettingSports clubs and physiotherapy clinics. ParticipantsThe Spanish version of the VISA-H (VISA-H-Sp) scale was administered to 101 subjects: 50 healthy runners and 51 patients with a clinical diagnosis of PHT. Main measuresThe Victorian Institute of Sports Assessment – Hamstrings. ResultsCronbach's alpha for the VISA-H-Sp was >0.8. The ICC 2,1 was 0.993 (95%CI 0.991–0.995). In the exploratory factor analysis, a one-factor solution explained 72.1% of the total variance. Athletes with PHT scored significantly lower in the VISA-H-Sp than healthy subjects (P < 0.001). The VISA-H-Sp score results in the PHT group showed significant correlations with SF-36 physical components (Spearman r’>0.6; P < 0.001), and low or non-significant association with psychological dimensions. The standard error of measurement was 1.45 whereas the minimal detectable change was 4.02 points. The responsiveness indicators included an effect size of 2.75, and a standardised response mean of 3.1 at discharge. ConclusionThe VISA-H-Sp shows adequate psychometric properties for assessing the severity of symptoms in Spanish-speaking athletes who suffer from PHT.

Validation of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire in hospitalized patients with major depressive disorder.

ObjectivesInteroception refers to the sensation, interpretation, and integration of internal somatic signals. Abnormalities in self-reported interoception are prevalent features of major depressive disorder (MDD) and may affect treatment outcomes. In the present study, we investigated the psychometric properties of the revised eight-dimensional and 37-item Multidimensional Assessment of Interoceptive Awareness questionnaire (the MAIA-2) in a severely depressed sample, after translating two updated scales (Not-Distracting, Not-Worrying) into German. Specifically, we examined the measure’s internal consistency reliability, sensitivity to change, and minimal important differences (MID) with a focus on patient’s antidepressive responses to treatment.MethodsThe study enrolled 110 participants (age: M = 46.85, SD = 11.23; female: 55.45%) undergoing hospital treatment, of whom 87 were included in the pre-post analysis. Participants completed a German translation of MAIA-2 and the Beck Depression Inventory-II (pre-/post-treatment). Internal consistency reliability was determined by Cronbach’s α/McDonalds’s ω, sensitivity to change was determined by effect sizes, and MIDs were determined by distribution- (0.5*SD) and anchor-based approaches (mean change method; ROC curve cut-points).ResultsDepression severity reduced over the course of treatment (Median = -65.22%), and 34.48% of patients achieved remission. Reliability was appropriate for post-treatment (range of ω: .70-.90), but questionable for two pre-treatment scales (Noticing: ω = .64; Not-Distracting: ω = .66). The eight dimensions of MAIA-2 were sensitive to change (standardized response mean: .32-.81; Cohen’s effect size: .30-.92). Distribution-based MIDs (.38-.61) and anchor-based mean change MIDs (remission vs. partial response: .00-.85; partial response vs. nonresponse: .08-.88) were established on the group level. For six scales, ROC cut-points (remission: .00–1.33; response: -.20–1.00) demonstrated accurate classification to treatment response groups on the individual level.ConclusionsThis study demonstrated the applicability of the MAIA-2 questionnaire in MDD. The updated version may have led to reliability improvements regarding the revised scales, but subthreshold reliability was evident prior to treatment. The measure’s dimensions were sensitive to change. MIDs were established that corresponded with antidepressive treatment outcomes. Our findings are consistent with a growing area of research which considers somatic feelings as key contributors to mental health.

Selection Approach to Identify the Optimal Biomarker Using Quantitative Muscle MRI and Functional Assessments in Becker Muscular Dystrophy

ObjectiveTo identify the best quantitative fat–water MRI biomarker for disease progression of leg muscles in Becker muscular dystrophy (BMD) by applying a stepwise approach based on standardized response mean (SRM) over 24 months, correlations with baseline ambulatory tests, and reproducibility.MethodsDixon fat–water imaging was performed at baseline (n = 24) and 24 months (n = 20). Fat fractions (FF) were calculated for 3 center slices and the whole muscles for 19 muscles and 6 muscle groups. Contractile cross-sectional area (cCSA) was obtained from the center slice. Functional assessments included knee extension and flexion force and 3 ambulatory tests (North Star Ambulatory Assessment [NSAA], 10-meter run, 6-minute walking test). MRI measures were selected using SRM (≥0.8) and correlation with all ambulatory tests (ρ ≤ −0.8). Measures were evaluated based on intraclass correlation coefficient (ICC) and SD of the difference. Sample sizes were calculated assuming 50% reduction in disease progression over 24 months in a clinical trial with 1:1 randomization.ResultsMedian whole muscle FF increased between 0.2% and 2.6% without consistent cCSA changes. High SRMs and strong functional correlations were found for 8 FF but no cCSA measures. All measures showed excellent ICC (≥0.999) and similar SD of the interrater difference. Whole thigh 3 center slices FF was the best biomarker (SRM 1.04, correlations ρ ≤ −0.81, ICC 1.00, SD 0.23%, sample size 59) based on low SD and acquisition and analysis time.ConclusionIn BMD, median FF of all muscles increased over 24 months. Whole thigh 3 center slices FF reduced the sample size by approximately 40% compared to NSAA.

Responsiveness of the SF-36 general health domain: observations from 14883 spine surgery procedures.

The study evaluated perceptions of general health (GH) after surgical treatment of spinal stenosis and disk herniation. We used a large longitudinally collected data set to explore differences in responsiveness between the SF-36 GH domain, EQ VAS, EQ-5D index, and SF-6D index. Patients, surgically treated for lumbar spinal stenosis or lumbar disk herniation between 2007 and 2017, were recruited from the national Swedish spine register. A total of 14,883 procedures were eligible for analysis. The responsiveness of the SF-36 GH domain to surgical treatment was evaluated with the standardized response mean (SRM) and effect size (ES). The internal consistency of the GH domain was evaluated, ceiling and floor effects were assessed, and the correlation between GH domain and EQ VAS was analyzed. The SF-36 GH domain did not respond to surgical treatment of spinal stenosis and disk herniation. In contrast, EQ VAS, EQ-5D index, and SF-6D showed moderate to large responsiveness. There were pronounced ceiling effects in items 11a-c of the SF-36 GH domain. There was a negative effect size of change for item 11c. The internal consistency of the GH domain was satisfactory. There were marked differences in the correlations between EQ VAS and the GH domain preoperatively and postoperatively. The SF-36 GH domain should be used with caution when evaluating effects on GH perceptions after spine surgery procedures. The lack of responsiveness is most probably explained by ceiling effects for items 11a-c and a negative effect size of change for item 11c.

Composite measures of pain, anxiety, and depressive (PAD) symptoms: Construct and predictive validity

ObjectivePain, anxiety, and depression (PAD) are common, co-occurring symptoms that adversely affect one another and may respond to common treatments. PAD composite measures would be useful for tracking treatment response in patients with PAD symptoms. The goal of this study is to compare 3 different PAD composite scales in terms of construct validity, responsiveness, and utility in predicting global improvement. MethodThe sample consisted of 294 primary care patients enrolled in a telecare trial for treating pain, anxiety, and depression. Assessments at baseline and 3 months included the Brief Pain Inventory, PHQ-9 depression scale, GAD-7 anxiety scale, PROMIS measures, Medical Outcomes Study Short-Form items, disability measures, and patient-reported global improvement. Construct validity of the PAD composite measures, their responsiveness, and their ability to predict global improvement was analyzed using Pearson correlations, standardized response means, and receiver operating characteristics analysis. ResultsPAD composite measures correlated strongly with one another, and moderately with measures of function, vitality, and disability. Each PAD composite measure demonstrated similar responsiveness in detecting improvement at 3 months as assessed by standardized response means (SRMs) and area under the curve (AUC analyses).The SRMs for partial and substantial global improvement corresponded to moderate (Cohen's d of 0.58 to 0.69) and large (0.81 to 0.93) effect sizes, respectively. ConclusionsThree different PAD composite measures demonstrate good construct validity as well as responsiveness in detecting global improvement of pain, anxiety and depression at 3 months.

Comparing the responsiveness of a generic and a musculoskeletal specific functional outcome measure in orthopaedic patients with operative fixation of pelvic ring, acetabulum, or tibia fractures: a comparison between single injury and multiply injured patients.

Objectives:This study compares the responsiveness, or the ability to detect clinical change in a disease, between the generic Short Form-36 (SF-36) and musculoskeletal specific Short Musculoskeletal Functional Assessment (SMFA) patient-reported outcome measures (PROMs) in the orthopaedic trauma population. Stratified analysis was performed to compare whether responsiveness differs between patients with single or multiple orthopaedic injuries.Design:Prospective case series.Setting:Level 1 Trauma Center.Patients:A total of 659 patients with orthopaedic trauma injuries to the pelvis, acetabulum, or tibia were included for analysis. There were 485 patients with a single isolated injury and 174 patients with multiple orthopaedic injuries.Intervention:None.Main Outcome Measurements:Responsiveness was calculated through the standard response mean (SRM), the proportion meeting a minimal clinically important difference, and floor and ceiling effects.Results:Between baseline and 6 months the magnitude of the SRM for SF-36 was consistently greater than that of SMFA in patients with single (P < .01) and multiple injuries (P < .01). Between 6 and 12 months, there were no differences in SRM across all cohorts. The proportion of patients who achieved minimal clinically important difference was consistently higher when assessed with SF-36 compared with SMFA between baseline and 6 months (81.8% vs 68.1%, P < .0001) and between 6 and 12 months (63.3% vs 55.4%, P = .01).A ceiling effect was only observed at baseline for the SMFA with 16.6% of patients achieving the maximal level of functioning detectable. No floor effects were seen in either PROM.Conclusion:This study demonstrates that SF-36 has superior responsiveness versus SMFA in both polytrauma and isolated injury patients and supports the collection of SF-36 as the primary PROM in prospective orthopaedic trauma studies irrespective of whether the patient has an isolated injury or multiple injuries.

Case Studies on Acupuncture Principles in Headaches

Objective: This observational cohort pilot study aimed to evaluate the effects of the acupuncture methods, Jiu Cang Zhen (JCZ) and Huang Guan (HG), on changes in headache intensity in an inpatient, multimodal Zurzach Headache Programme (ZHP). Methods: Study participants consisted of patients diagnosed with chronic headache disorder (headache ds, 30 days per month) or daily persistent headache. All patients received conventional therapies with active and passive approaches. The patient group was treated with JCZ and HG acupuncture methods, receiving a total of six to eight acupuncture sessions of 50 to 60 minutes each, during a 3–4-week multimodal ZHP at the RehaClinic Bad Zurzach. Pain intensity was quantified using a Numerical Rating Scale (NRS) before and after each acupuncture therapy session. Results: Ten patients were recruited, six women and four men, with a mean age of 41.7 (standard deviation, [SD] =13.9). A reduction in headache intensity was reported by all patients in each of the sessions. The average NRS for pain was 4.21 (SD = 1.44) before acupuncture and 1.24 (SD = 0.93) after acupuncture (means first by number of sessions, then per n = 10 patients). This resulted in a mean difference of 2.97 (SD = 1.04), corresponding to a standardized response mean of 2.85 (95% confidence interval: 2.11–3.60, one-tailed P < 0.001), meaning there was a large effect. Conclusions: This pilot study shows that JCZ and HG are suitable acupuncture methods for reducing headache intensity in the treatment of headaches. A comparison with the conventional classical acupuncture methods from the acupuncture textbook for traditional Chinese medicine students in China, exploration with a larger patient group, and prolonged monitoring of pain behavior could be foci of follow-up investigations.

The mSQUASH; a valid, reliable and responsive questionnaire for daily physical activity in patients with axial spondyloarthritis

AimAdaptation of the Short QUestionnaire to Assess Health-enhancing physical activity (SQUASH) in order to improve measurement properties in axSpA patients. MethodsThe original SQUASH was adapted using a qualitative stepwise approach with in-depth interviews including healthcare professionals and patients. Content validity was explored by comparing modified-SQUASH (mSQUASH) and original SQUASH. Next, mSQUASH was validated according to the OMERACT filter. International Physical Activity Questionnaire (IPAQ) was used as comparator and tri-axial accelerometer as gold standard for criterion validity and classification accuracy of intensity. Construct validity was assessed using Spearman correlations with clinical outcome assessments. For test-retest reliability, intra-class correlation coefficients (ICCs) were calculated. Responsiveness was assessed using standardized response mean (SRM), stratified by Anchor method. ResultsThe mSQUASH measured a systematically higher activity count and had less missing values (8% vs. 16%) then SQUASH. mSQUASH correlated better with accelerometer compared to IPAQ (ρ = 0.60 vs. ρ = 0.34). Accelerometer measured most activity in light intensity, whereas mSQUASH and IPAQ predominately measured moderate intensity. Correlations with ASDAS, BASDAI, BASFI and ASQoL were better for mSQUASH then IPAQ. Test-retest reliability was good in both questionnaires. In contrast to IPAQ, responsiveness was in correspondence with self-reported changes in physical activity for mSQUASH (SRM -0.84 for improvement and 0.88 for decrease). The average completion time of the mSQUASH was 7 minutes. ConclusionsThe development of the mSQUASH resulted in an easy applicable, valid, reliable and responsive questionnaire for the assessment of daily physical activity in axSpA patients, which can be used in research and daily clinical practice.

Usefulness of a global rating change scale for contact lens discomfort evaluation

ObjectivesTo evaluate the usefulness of a global rate of change scale (GRCS) to detect variations in contact lens discomfort (CLD). MethodsSymptomatic contact lens (CL) wearers were recruited according to the ‘Contact Lens Dry Eye Questionnaire-8’ (CLDEQ-8). At the baseline visit, subjects scored their comfort following insertion of their habitual CL using a 0–100 visual analogue scale (VAS). After 4–10 h of CL wear, comfort was again self-evaluated with the VAS and with a GRCS (range, −50 to +50). Then, a daily disposable CL (DDCL) was fitted. After one month of DDCL wear, a follow-up visit was conducted where the same evaluations as the baseline visit were performed. Changes in comfort were estimated using a Student's t-test for normal variables and the Friedman test for multiple comparisons of non-parametric variables. Internal responsiveness was measured by calculating the standardised response mean. Agreement between scales was estimated by the intraclass correlation coefficient (ICC). ResultsTwenty-nine (22 females and 7 males) CL wearers with a mean age of 23.4 ± 5.4 years participated in the study. There was a significant decrease in comfort at both visits detected by the GRCS (baseline = −13.58 ± 17.48, p < 0.001; follow up = −6.86 ± 12.69, p = 0.007). However, the VAS did not detect that change, either at baseline (insertion = 64.28 ± 18.72 vs removal = 52.89 ± 17.64, p = 1.000) or follow-up visit (insertion = 81.97 ± 12.91 vs removal = 76.48 ± 16.02, p = 1.000). Comfort at insertion and removal times was significantly higher with the DDCL (p = 0.008 at insertion and p = 0.004 at removal). The standardised response mean was greater with the GRCS than the VAS at baseline (0.78 vs 0.63) and follow-up (0.54 vs 0.37) visits. Agreement between both scales was moderate and significant (p < 0.001) for both visits, ICC: 0.674 (95 % confidence interval (CI):0.411–0.833) (baseline) and 0.652 (95 % CI:0.377–0.821) (follow-up visit). ConclusionsThe GRCS can detect slight changes in CL wear comfort and shows higher responsiveness than the VAS. This subjective scale can allow detection of changes in comfort in a simple and quick way.

Changes in fear of movement in patients attending cardiac rehabilitation: responsiveness of the TSK-NL Heart

Abstract Funding Acknowledgements Type of funding sources: None. Background An important factor related to low physical activity in cardiac patients is fear of movement (kinesiophobia). The setting of cardiac rehabilitation (CR) seems suitable for targeting kinesiophobia. Nevertheless, the impact of CR on kinesiophobia is currently unknown, partly due to the absence of information on the responsiveness of instruments to measure kinesiophobia. Purpose To determine the responsiveness of the Dutch version of the Tampa Scale for Kinesiophobia questionnaire (TSK-NL Heart), to asses changes in kinesiophobia during participation in CR and to assess predictors of high levels of kinesiophobia at completion of CR. Methods This study was performed among 109 patients (mean age: 61 years; 76% men) who participated in a 6- till 12-week CR program. Kinesiophobia was measured using the TSK-NL Heart questionnaire. To determine the responsiveness of the TSK-NL Heart, the Cardiac Anxiety Questionnaire (CAQ) and the general anxiety scale of the Hospital Anxiety and Depression Scale (HADS-A) were used as external measures. All questionnaires were completed pre- and post-CR. Internal responsiveness was estimated by calculating the effect size (ES) and standardized response mean (SRM). External responsiveness was determined by calculating the correlation between change scores on the TSK-NL heart and on the external measures. Furthermore, univariate logistic regression analysis was performed with the dichotomized TSK-NL Heart score post-CR as dependent variable (high vs low scores) and baseline characteristics (age, sex, reason for referral and pre-CR scores on the TSK-NL Heart, CAQ and HADS) as predictor variables. Results Prevalence of a high levels of kinesiophobia improved from 40.4% pre-CR to 25.7% at completion of CR (p = 0.05). Both the ES and the SRM of the TSK change score were moderate for patients with an improved CAQ and HADS-A score (respectively ES = 0.52; SRM = 0.57 and ES = 0.54; SRM = 0.60) and small for patients with a stable score (ES = 0; SRM = 0 and ES = 0.26; SRM = 0.36). There was a moderate correlation between the TSK-NL Heart change score and the CAQ (Rs = 0.30, p = 0.023) and a small correlation between the TSK-NL Heart change score and the HADS-A (Rs =0.21, p = 0.107). The odds of having high kinesiophobia levels post-CR were increased by having a high level of kinesiophobia pre-CR (OR= 9.83, 95%CI: 3.52-27.46), a higher baseline score on the CAQ (OR = 1.12, 95%CI: 1.06-1.19), and a higher baseline score on the HADS-A (OR = 1.26, 95% CI: 1.11-1.42). Conclusion The TSK-NL Heart has moderate responsiveness. In addition, this study shows that there are reductions in kinesiophobia during the course of CR. Nevertheless, a large number of patients (26%) still had high levels of kinesiophobia at completion of CR. Interventions targeting kinesiophobia should focus on patients that enter CR with high levels of kinesiophobia, cardiac anxiety and generic anxiety.

Development of a valid Chinese version of the Cumberland Ankle Instability Tool in Chinese-speaking patients with chronic ankle instability disorders

As an effective scale for the condition assessment of patients with chronic ankle instability (CAI), the Cumberland Ankle Instability Tool (CAIT) is the most widely used scale, and its original version is written in English. Therefore, the purpose of our study is to apply the CAIT to Chinese patients and evaluate its responsiveness, reliability, and validity in terms of Chinese patients with CAI. First, we adapted the CAIT into the Chinese edition (CAIT-C), through which cross-cultural adaptation and translation can be carried out in a five-step procedure. Next, recruited patients completed the three periods of the Foot and Ankle Ability Measure (FAAM), CAIT-C, and the Medical Outcomes Study Short-Form 36 (SF-36) scales. Afterward, to assess the responsiveness, reliability, and validity, we calculated the standardized response mean (SRM), effect size (ES), Spearman's correlation coefficient (rs), minimal detectable change (MDC), standard error of measurement (SEM), intraclass correlation coefficient (ICC), and Cronbach’s alpha. Generally, in the use of CAI, 131, 119, and 86 patients favorably completed the three periods of the scales. The CAIT-C was proven to have good test–retest reliability (ICC = 0.930) and fine internal consistency (Cronbach’s alpha = 0.845–0.878). The low-value of MDC (0.04–2.28) and SEM (1.73) show it is possible to detect clinical changes when we take advantage of CAIT-C. Good or moderate correlations (rs = 0.422–0.738) were gained from the physical subscales of the SF-36 and the subscales of the FAAM and the CAIT-C. Fair or poor correlations (rs = 0.003–0.360) were gained between the mental subscales of the SF-36 and the CAIT-C, which sufficiently indicated that the CAIT-C had good validity. Moreover, good responsiveness was observed in the CAIT-C (ES = 1.316, SRM = 1.418). The CAIT-C scale is an effective, valid, and reliable tool to evaluate Chinese CAI patients.

Responsiveness and minimal important change of the Pain Catastrophizing Scale in people with chronic low back pain undergoing multidisciplinary rehabilitation.

The Pain Catastrophizing Scale (PCS), a widely used tool to assess catastrophizing related to spinal disorders, shows valid psychometric properties in general but the minimal important change (MIC) is still not determined. The aim of this study was to assess responsiveness and MIC of the PCS in individuals with chronic low back pain (LBP) undergoing multidisciplinary rehabilitation. Prospective observational study. The setting was outpatient rehabilitation hospital. Two hundred and five patients with chronic LBP. Before and after an 8-week multidisciplinary rehabilitation program, 205 patients completed the Italian version of the PCS (PCS-I). We calculated the PCS-I responsiveness by distribution-based methods (effect size [ES], standardized response mean [SRM], and minimum detectable change [MDC]) and anchor-based methods [receiver operating characteristic (ROC) curves]. After the program, participants completed a 7-point global perceived effect scale (GPE), based on which they were classified as "improved" vs. "stable." ROC curves computed the best cut-off level (taken as the MIC) between the two groups. ROC analysis was also performed on subgroups according to patients' baseline PCS scores. ES, SRM and MDC were 0.71, 0.67 and 7.73, respectively. ROC analysis yielded an MIC of 8 points (95% confidence interval [CI]: 6-10; area under the curve [AUC]: 0.88). ROC analysis of the PCS subgroups confirmed an MIC of 8 points (95%CI: 6-10) for no/low catastrophizers (score <30, N.=159; AUC: 0.90) and indicated an MIC of 11 points (95%CI: 8-14) for catastrophizers (score >30, N.=33; AUC: 0.84). The PCS-I showed good ability to detect patient-perceived clinical changes in chronic LBP postrehabilitation. The MIC values we determined provide a benchmark for assessing individual improvement in this clinical context. The present study calculated - in a sample of people with chronic LBP - the responsiveness and MIC of the PCS. These values increase confidence in interpreting score changes, enhancing their meaningfulness for both research and clinical contexts.

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.

Measurement of Change with the Short Form of the OPD Structure Questionnaire (OPD-SQS)

The transdiagnostic concept of personality structure plays a key role in psychodynamic nosology, since many mental and psychosocial disorders are considered mainfestations of structural vulnerabilities and deficits. Therefore, structural diagnostics is of particular importance, especially with respect to the planning of tailor-made psychotherapeutic interventions. Because changes in personality structure are increasingly being considered as a relevant therapeutic goal, any measures employed towards achieving this goal should be sensitive enough to capture these changes appropriately. Although the short form of the OPD Structure Questionnaire (OPD-SQS) can easily be administered and is therefore frequently used in clinical and research settings, its sensitivity to change has not yet been analyzed. Two large, independent and diagnostically heterogeneous samples of inpatient psychotherapy patients (n=1183 and n=967, respectively) completed the OPD-SQS both at admission and before discharge. Standardized Effect Size (SES), Standardized Response Mean (SRM) and Smallest Real Difference (SRD) were computed as indicators of the measure's ability to capture change. For the OPD-SQS and its subscales, low effect sizes were found in both samples (SES between 0.23 and 0.48; SRM between 0.27 and 0.53). Additionally, it was demonstrated that greater changes among patients with structural deficits were detectable with the OPD-SQS compared to those without structural deficits, and that these group differences were significant. By means of the SRD, we determined a proportion of about 22% of patients with significantly structurally improved changes in both samples. Despite some methodological issues, our findings suggest that the OPD-SQS is suitable for measuring changes in personality structure in inpatients between the beginning and the end of treatment. Since studies on the sensitivity to change of similar assessment tools are still pending, it is not yet possible to formulate any empirically validated recommendations as to which of the measure best captures therapeutically induced changes in personality structure.

Properties of SF-6D when longitudinal data from 16,398 spine surgery procedures is applied to 9 national SF-6D value sets

Background and purpose — There are several national value sets for SF-6D. For studies conducted in countries without a country-specific value set the authors may use a value set from a neighboring or culturally similar county. We evaluated the consequences of using different national value sets in SF-6D index-based outcome analyses. Patients and methods — Patients surgically treated for lumbar spinal stenosis or lumbar disk herniation between 2007 and 2017 were recruited from the national Swedish spine register. 16,398 procedures were eligible for analysis. The SF-6D health states were coded to SF-6D preference indices using value sets for 9 countries. The SF-6D index distributions were then estimated with kernel density estimation. The change in SF-6D index before and after treatment was evaluated with the standardized response mean (SRM). Results — There was a marked variability in mean and shape for the resulting SF-6D index distributions. There were considerable differences in SF-6D index distribution shape before and after treatment using the same value set. The effect sizes of 2-year change (SRM) were in most cases similar when the 9 value sets were applied on pre- and post-treatment data. Interpretation — We found a marked variability in SF-6D index distributions when a single large data set was applied to 9 national SF-6D value sets. Consequently, we recommend that SF-6D index data from studies conducted in countries without country-specific SF-6D value sets is interpreted with caution.

A novel fluorescence optical imaging scoring system for hand synovitis in rheumatoid arthritis-validity and agreement with ultrasound.

To develop and validate a new semiquantitative fluorescence optical imaging (FOI) scoring system-the FOI Enhancement-Generated RA Score (FOIE-GRAS) for synovitis assessment in the hand. The development of FOIE-GRAS was based on consensus of four experts in musculoskeletal imaging. Forty-six RA patients, eligible for treatment intensification and with ≥1 clinically swollen joints in the hands, and 11 healthy controls were included. FOI, ultrasound and clinical assessment of both hands were obtained at baseline and for RA patients after 3 and 6 months' follow-up. Twenty RA patients had an FOI rescan after 4 h. Synovitis was scored using FOIE-GRAS and the OMERACT ultrasound synovitis scoring system. All FOI images were scored by two readers. Inter-scan, inter- and intra-reader reliability were determined. Furthermore, FOIE-GRAS agreement with ultrasound and responsiveness was assessed. FOIE-GRAS synovitis was defined as early enhancement, and scores were based on the degree of coverage of the specific joint region after 3 s (0-3). Inter-scan, intra- and inter-reader intraclass correlations coefficients (ICC) were good to excellent for all baseline scores (0.76-0.98) and moderate to good for change (0.65-76).The FOIE-GRAS had moderate agreement with ultrasound (ICC 0.30-0.54) for total score, a good standardized response mean (>0.80), and moderate correlation with clinical joint assessment and DAS28-CRP. The median (interquartile range) reading time per FOI examination was 133 (109, 161) s. Scores were significantly lower in controls [1 (0, 4)] than RA patients [11 (6, 19)]. The FOIE-GRAS offers a feasible and reliable assessment of synovitis in RA, with a moderate correlation with ultrasound and DAS28-CRP, and good responsiveness.

The American Shoulder and Elbow Surgeons score has excellent correlation with the Western Ontario Osteoarthritis score.

The purpose of this study was to compare the correlation, responsiveness, and responder and administrator burden of the American Shoulder and Elbow Surgeons (ASES) score with the Western Ontario Osteoarthritis of the Shoulder (WOOS) score for patients undergoing total shoulder arthroplasty. The goal was to determine whether one score was superior to the other to limit the use of multiple scoring measures when tracking patient outcomes. The hypothesis of this study was that for patients undergoing total shoulder arthroplasty, the WOOS score would have (1) a high level of correlation with the ASES score, (2) comparable responsiveness to the ASES score, and (3) a higher responder and administrator burden than the ASES score. We performed a retrospective review of a database of patients undergoing total shoulder arthroplasty in which the ASES score was recorded with the WOOS 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 and by type of arthroplasty (anatomic vs. reverse). Responsiveness was determined by calculating the standardized response mean and the effect size of both scores. Responder and administrator burden was examined using 50 consecutive preoperative patients to determine the number of incorrectly completed WOOS and ASES scores. The correlation of the ASES and WOOS scores for all patients was excellent (n = 1218, r = 0.88, P < .0001). The correlation of the ASES and WOOS scores was excellent for patients undergoing anatomic total shoulder arthroplasty (n = 695, r = 0.71, P < .0001) and reverse total shoulder arthroplasty (n = 523, r = 0.88, P < .0001). The correlation of preoperative scores was strong-moderate (n = 606, r=0.62, P < .0001), and that of postoperative scores was strong-moderate (n = 612, r = 0.69, P < .0001). The standardized response mean (WOOS score, 2.1; ASES score, 2.1) and the effect size (WOOS score, 3.0; ASES score, 3.0) demonstrated comparable responsiveness. Twenty-six percent of the WOOS scores were completed incorrectly and were invalid compared with 0% of the ASES scores (P < .0001). There is excellent correlation and comparable responsiveness between the ASES score and WOOS score. Including these scores simultaneously when tracking patient-determined outcomes appears to be redundant and therefore unnecessary. Because there is higher responder and administrative burden for the WOOS score, we recommend use of the ASES score over the WOOS score in patients undergoing total shoulder arthroplasty.

Dimensions Used in Instruments for QALY Calculation: A Systematic Review

Economic assessment is of utmost importance in the healthcare decision-making process. The quality-adjusted life-year (QALY) concept provides a rare opportunity to combine two crucial aspects of health, i.e., mortality and morbidity, into a single index to perform cost-utility comparison. Today, many tools are available to measure morbidity in terms of health-related quality of life (HRQoL) and a large literature describes how to use them. Knowing their characteristics and development process is a key point for elaborating, adapting, or selecting the most well-suited instrument for further needs. In this aim, we conducted a systematic review on instruments used for QALY calculation, and 46 studies were selected after searches in four databases: Medline EBSCO, Scopus, ScienceDirect, and PubMed. The search procedure was done to identify all relevant publications up to 18 June 2020. We mainly focused on the type of instrument developed (i.e., generic or specific), the number and the nature of dimensions and levels used, the elicitation method and the model selected to determine utility scores, and the instrument and algorithm validation methods. Results show that studies dealing with the development of specific instruments were mostly motivated by the inappropriateness of generic instruments in their field. For the dimensions’ and levels’ selection, item response theory, Rasch analysis, and literature review were mostly used. Dimensions and levels were validated by methods like the Loevinger H, the standardised response mean, or discussions with experts in the field. The time trade-off method was the most widely used elicitation method, followed by the visual analogue scale. Random effects regression models were frequently used in determining utility scores.

Validation of the Radiographic Global Impression of Change (RGI-C) score to assess healing of rickets in pediatric X-linked hypophosphatemia (XLH).

Rickets is a primary manifestation of pediatric X-linked hypophosphatemia (XLH) - a rare progressive hereditary phosphate-wasting disease. Severity is quantified from radiographs using the Rickets Severity Scale (RSS). The Radiographic Global Impression of Change (RGI-C) is a complementary assessment in which a change score is assigned based on differences in the appearance of rickets on pairs of radiographs compared side by side. The current study evaluated the reliability, validity, and sensitivity to change of the RGI-C specifically in pediatric XLH. The reliability, validity, and sensitivity to change of the RGI-C were evaluated using data from two studies in pediatric XLH (113 children aged 1-12years) in which burosumab treatment significantly improved rickets severity. Intra-rater and inter-rater reliability were assessed by three pediatric radiologists. Intra-rater reliability for RGI-C global score was >90% for agreement within 1 point, with weighted kappa values >0.5, indicating moderate to almost perfect agreement. Inter-rater reliability was also >90% (0.47-0.52 for all reader pairs; moderate agreement). The RGI-C global score showed significant relationships with changes from baseline to week 64 in serum phosphorus (r=-0.397), alkaline phosphatase (-0.611), total RSS (-0.672), standing height (0.268), and patient-reported global functioning (0.306) and comfort/pain functioning (0.409). Based on standardized response means, RGI-C global scores were sensitive to change in RSS, differentiating between those considered improved and greatly improved. Results for validity and sensitivity to change were similar for the RGI-C wrist, knee, and standing long leg scores. The RGI-C is a reliable, valid, and sensitive measure in pediatric XLH, and complementary to the RSS.

Validity and responsiveness of EQ-5D-5L and SF-6D in patients with health complaints attributed to their amalgam fillings: a prospective cohort study of patients undergoing amalgam removal

BackgroundEvidence of health utility changes in patients who suffer from longstanding health complaints attributed to dental amalgam fillings are limited. The change in health utility outcomes enables calculating quality-adjusted life-year (QALY) and facilitates the comparison with other health conditions. The purpose of this study was to estimate the validity and responsiveness of the EQ-5D-5L and SF-6D utilities following removal of dental amalgam fillings in patients with health complaints attributed to their amalgam fillings, and examine the ability of these instruments to detect minimally important changes over time.MethodsPatients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, were recruited to a prospective cohort study in Norway. Two health state utility instruments, EQ-5D-5L and SF-6D, as well as self-reported general health complaints (GHC-index) and visual analogue scale (EQ-VAS) were administered to all patients (n = 32) at baseline and at follow-up. The last two were used as criteria measures. Concurrent and predictive validities were examined using correlation coefficients. Responsiveness was assessed by the effect size (ES), standardized response mean (SRM), and relative efficiency. Minimally important change (MIC) was examined by distribution and anchor-based approaches.ResultsConcurrent validity of the EQ-5D-5L was similar to that of SF-6D utility. EQ-5D-5L was more responsive than SF-6D: the ES were 0.73 and 0.58 for EQ-5D-5L and SF-6D, respectively; SRM were 0.76 and 0.67, respectively. EQ-5D-5L was more efficient than SF-6D in detecting changes, but both were less efficient compared to criteria-based measures. The estimated MIC of EQ-5D-5L value set was 0.108 and 0.118 based on distribution and anchor-based approaches, respectively. The corresponding values for SF-6D were 0.048 and 0.064, respectively.ConclusionsIn patients with health complaints attributed to dental amalgam undergoing amalgam removal, both EQ-5D-5L and SF-6D showed reasonable concurrent and predictive validity and acceptable responsiveness. The EQ-5D-5L utility appears to be more responsive compared to SF-6D.Trial registration The research was registered at ClinicalTrials.gov., NCT01682278. Registered 10 September 2012, https://clinicaltrials.gov/ct2/show/NCT01682278.