Determination of the Minimal Clinically Important Difference (MCID) for Ocular Subjective Responses.

Purpose: To determine the minimal clinically important difference (MCID) for contact lens (CL)-related subjective responses and explore whether MCID values differ between subjective responses and study designs. Methods: This was a retrospective analysis of data from seven one-week bilateral crossover studies and 14 one-day contralateral CL studies. For comfort, dryness, vision, or ease of insertion, participants rated on a 0-100 visual analogue scale (VAS) and indicated lens preference on a five-point Likert scale featuring strong, slight, and no preferences. For each criterion, four MCID estimates were calculated and averaged: mean VAS score difference for "slight preference," lower limit of 95% confidence interval VAS score difference for "slight preference," difference in mean VAS score difference between "slight" and "no preference" and 0.5 standard deviation of VAS scores. Results: The four calculation methods generated a small range of MCID values. For bilateral studies, the averaged MCID was 7.2 (range 5.4-8.8) for comfort, 8.1 (5.2-10.6) for dryness, 7.1 (5.5-9.3) for vision and 7.6 (6.0-10.5) for ease of insertion. For contralateral studies, the averaged MCID was 6.9 (6.1-7.6) for comfort at insertion and 7.5 (6.8-8.2) for end-of-day comfort. Conclusions: This work demonstrated very similar MCID values across subjective responses and study designs, in a population of habitual soft CL wearers. In all cases, MCID values were on average seven units on a 0 to 100 VAS. Translational Relevance: This work provides MCID values which are important for interpreting ocular subjective responses and planning clinical studies.

Comparison of case-based and lecture-based learning in dental fluorosis diagnostic ability with visual analog scale assessment.

OBJECTIVE: This study aimed to compare the impact of case-based learning (CBL) versus lecture-based learning (LBL) on dental students' clinical decision-making regarding DF severity using Visual Analog Scale (VAS) scoring. METHODS: Eighty first-year graduate dental students were randomly assigned to either the CBL (n = 38) or LBL (n = 42) groups. Both groups received instruction on DF diagnosis, with CBL involving small group sessions analyzing real cases and LBL involving traditional lectures. Effectiveness was assessed by presenting 32 dental fluorosis cases with Thylstrup-Fejerskov Index (TSIF) scores ranging from 0 to 7 through slide presentations to both groups for VAS assessment. Five evaluators of each group randomly selected were asked to repeat the rating 2 weeks later. Statistical analysis included two-way ANOVA for group and gender differences, intra-class correlation coefficient (ICC) for reliability, and Spearman correlation coefficients for validity. RESULTS: Variations in VAS scores were observed between CBL and LBL groups, with no significant gender impact. Excellent inter- and intra-evaluator agreement was found for VAS scoring in both groups, indicating its reliability. Validation against established indices (such as DI and TSIF) demonstrated strong correlations, with CBL students exhibiting higher correlations. CONCLUSIONS: CBL enhances students' clinical decision-making and proficiency in DF diagnosis, as evidenced by more consistent and accurate VAS scoring compared to LBL. These findings highlight the importance of innovative educational strategies in dental curricula, with implications for improving training quality and clinical outcomes. TRIAL REGISTRATION: The study was registered at the Clinical Research Center, Hospital of Stomatology, Wuhan University (Registration code: HGGC-036).

Visual vertigo in children: Adaptation and validation of the visual vertigo analogue scale to European Portuguese.

BACKGROUND: Visual vertigo occurs after vestibular and non-vestibular pathology and can be present in children and adolescents. It can be assessed by "the Visual Vertigo Analogue Scale" (VVAS), a questionnaire with a Portuguese version for adults. OBJECTIVES: To perform the adaptation to pediatric age and validation of VVAS in European Portuguese. METHODS: This prospective study involved the pediatric adaptation of the Portuguese VVAS, according to recognized guidelines. It was then completed by 30 healthy controls and 18 children with vestibulopathy. Patient caregivers also completed the Dizziness Handicap Inventory - Patient Caregivers (DHI-PC) to further explore the link between questionnaires. Groups were compared for severity of visual vertigo and VVAS test-retest reliability was tested. RESULTS: The VVAS score was significantly higher in vestibular group (p < 0.001). No statistically significant differences were found between VVAS initial and re-test scores (p = 0.33). VVAS severity scores showed a positive correlation with DHI-PC (r = 0.598, p = 0.009). CONCLUSION: The present Pediatric adaptation of VVAS in European Portuguese shows good psychometric properties for the assessment of visual vertigo. A positive correlation with the DHI-PC was showed, establishing the potential use of both questionnaires in the evaluation of vertigo children.

Defining minimal clinically important difference, patient acceptable symptomatic state and substantial clinical benefit for the visual analog scale pain score after arthroscopic rotator cuff repair.

INTRODUCTION: Patient satisfaction after arthroscopic rotator cuff repair (RCR) is commonly assessed with patient-reported outcome measures (PROMs), and there is an increased need to establish clinical relevance within these measures. The purpose of this study was to (1) define minimal clinically important difference (MCID), patient acceptable symptomatic state (PASS), and substantial clinical benefit (SCB) for the visual analog scale (VAS) pain score in patients undergoing arthroscopic RCR, and (2) identify preoperative predictors of achieving each of these threshold values. METHODS: Data from consecutive patients who underwent primary arthroscopic rotator cuff repair study between 2010 and 2016 were prospectively collected. Baseline data and VAS pain scores were collected preoperatively and at 1 year and 2 years postoperatively. MCID, PASS and SCB were determined using an anchor-based approach, with anchor questions assessing postoperative satisfaction and expectation fulfillment. Multivariate logistic regression analysis was also used to identify preoperative predictors for achieving MCID, PASS, and SCB. RESULTS: A total of 286 patients were included in the final analysis, with an average age of 60.2 â€‹± â€‹10.4 and the majority being female (61.2%). The values for the VAS pain score identified to represent MCID, PASS, and SCB, respectively, at 1-year postoperatively were: 5, 2, and 1. The rates of achieving clinically significant improvement based on VAS were 60.5%, 63.3%, and 57.2%, respectively. A higher preoperative VAS was predictive for achieving MCID (odds ratio [OR], 1.84; P â€‹< â€‹0.01). CONCLUSION: This study identified threshold VAS pain scores of 5, 2, and 1 for achieving MCID, PASS, and SCB, respectively, at 1-year follow-up after arthroscopic rotator cuff repair. A higher preoperative VAS pain score was also identified as a statistically significant predictor of attaining MCID after arthroscopic rotator cuff repair. LEVEL OF EVIDENCE: II.

The psychometrics of rating facial attractiveness using different response scales.

Perceiving facial attractiveness is an important behaviour across psychological science due to these judgments having real-world consequences. However, there is little consensus on the measurement of this behaviour, and practices differ widely. Research typically asks participants to provide ratings of attractiveness across a multitude of different response scales, with little consideration of the psychometric properties of these scales. Here, we make psychometric comparisons across nine different response scales. Specifically, we analysed the psychometric properties of a binary response, a 0-100 scale, a visual analogue scale, and a set of Likert scales (1-3, 1-5, 1-7, 1-8, 1-9, 1-10) as tools to measure attractiveness, calculating a range of commonly used statistics for each. While certain properties suggested researchers might choose to favour the 1-5, 1-7 and 1-8 scales, we generally found little evidence of an advantage for one scale over any other. Taken together, our investigation provides consideration of currently used techniques for measuring facial attractiveness and makes recommendations for researchers in this field.

Are visual analogue scales valid instruments to measure psychological pain in psychiatric patients?

OBJECTIVE: The Psychological-Physical-Pain Visual Analogue Scale (PPP-VAS) was thought to probably help in identifying patients at risk of suicide. However, no data on its validity to measure psychological pain was available. Our main aim was to investigate the convergent validity of the PPP-VAS using two well-validated scales of psychological pain, the Orbach and Mikulincer Mental Pain scale (OMMP) and the Holden et al. Psychache Scale. METHODS: This multicentre study recruited a total of 1618 adult psychiatric inpatients and outpatients in Italy. Psychological pain was evaluated using the OMMP, Holden et al., and PPP-VAS scales. Psychiatric status, suicidal status, physical pain, depression, and hopelessness were also assessed. RESULTS: A structural equation model (SEM) using the items of psychological pain from the PPP-VAS showed that items loaded significantly on the psychological pain factor and showed good fit. Similarly, a second SEM model using the three scales of psychological pain showed acceptable fit and converged into a psychological pain construct. Correlations between the PPP-VAS and depression, hopelessness, and physical pain showed moderate correlations (r = 0.43 to r = 0.67). Finally, psychological pain evaluated with the PPP-VAS was significantly related with recent suicidal ideation in all patients (OR [95 % CI] = 1.07 [1.05, 1.09]) and recent suicide attempts in moderately to severely depressed patients, OR [95 % CI] = 1.01 [1.02, 1.03]. CONCLUSION: The PPP-VAS showed good psychometric properties in evaluating psychological pain. The characteristics of the PPP-VAS makes this scale a great option for its use in clinical practice to detect patients at risk of suicide.

Palatability evaluation of orally disintegrating tablets using a visual analog scale in clinical trials.

OBJECTIVE: Visual analog scale (VAS) can be used to evaluate multiple parameters. There have been no reports on the verification of order effects or reproducibility of the VAS method for overall palatability of oral dosage forms. The purpose of this study was to assess the validity of a method for evaluating the palatability of orally disintegrating tablets (ODTs) using a 100-mm VAS. MATERIALS AND METHODS: We conducted clinical trials to evaluate the overall palatability, taste, and scent of 3 ODTs (F1, F2, F3) that contained famotidine (20, 10, and 5 mg, respectively). The study protocol was approved by the Research Ethics Committee of the University of Shizuoka, Japan (No. 21 - 36). To investigate the intergroup reproducibility of the VAS evaluation, 40 participants were divided into three groups, and each group underwent human gustatory sensation test of F1, F2, and F3, performed using a crossover design with 6 different tasting sequences. To evaluate intragroup reproducibility of the VAS evaluation, the participants assessed the same ODTs twice. RESULTS: The VAS scores for overall palatability followed the same order (F3>F2>F1) in all groups. The VAS scores for the overall palatability of F1, F2, and F3 did not significantly differ between the first and second evaluations. The Kruskal-Wallis test indicated a minimal impact of the assessment order on ODT evaluations. We confirm the reliability and reproducibility of the VAS method for evaluating ODT palatability. CONCLUSION: The VAS method for assessing ODT palatability provides accurate information and can contribute to the design and manufacture of patient-friendly pharmaceutical products.

A Bayesian hierarchical model for the analysis of visual analogue scaling tasks.

In psychophysics and psychometrics, an integral method to the discipline involves charting how a person's response pattern changes according to a continuum of stimuli. For instance, in hearing science, Visual Analog Scaling tasks are experiments in which listeners hear sounds across a speech continuum and give a numeric rating between 0 and 100 conveying whether the sound they heard was more like word "a" or more like word "b" (i.e. each participant is giving a continuous categorization response). By taking all the continuous categorization responses across the speech continuum, a parametric curve model can be fit to the data and used to analyze any individual's response pattern by speech continuum. Standard statistical modeling techniques are not able to accommodate all of the specific requirements needed to analyze these data. Thus, Bayesian hierarchical modeling techniques are employed to accommodate group-level non-linear curves, individual-specific non-linear curves, continuum-level random effects, and a subject-specific variance that is predicted by other model parameters. In this paper, a Bayesian hierarchical model is constructed to model the data from a Visual Analog Scaling task study of mono-lingual and bi-lingual participants. Any nonlinear curve function could be used and we demonstrate the technique using the 4-parameter logistic function. Overall, the model was found to fit particularly well to the data from the study and results suggested that the magnitude of the slope was what most defined the differences in response patterns between continua.

Age-stratified analysis of HTO and UKA clinical effects in cross-indicated anterior medial osteoarthritis.

PURPOSE: To compare clinical outcomes of high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) for anterior medial osteoarthritis (AMOA) as well as offer surgical recommendations through age stratification. METHODS: Between May 2019 and May 2021, 68 cross-indicated AMOA patients were analyzed. The patients were divided into HTO and UKA groups and further into two age groups of 55-60 and 60-65 years. Additionally, general data, visual analog scale (VAS) score, and Hospital for Special Surgery knee score (HSS) were analyzed. RESULTS: All the patients were followed up for 18 months. Knee joint HSS significantly improved, and VAS score decreased in both groups (P < 0.05). In the 55-60 age group, HTO showed superior knee HSS at 1 and 3 months (P < 0.05), with no significant difference at 6, 12, and 18 months. HTO had a significantly lower VAS score at one month, and the VAS scores of the two groups decreased gradually with no significant difference. In the 60-65 age group, the UKA group showed superior knee joint HSS at one month, with no significant difference at 3, 6, 12, and 18 months. The UKA group had a significantly lower VAS score at one month, and both groups' VAS scores decreased gradually with no significant difference. CONCLUSION: Both methods yield satisfactory results for AMOA cross-indications, improving knee joint function. The observed recovery trends have implications for personalized surgical recommendations, guiding interventions based on age-specific considerations for optimal outcomes in anterior medial osteoarthritis cases.

Functional and esthetic outcomes of functional rhinoplasty for internal nasal valve dysfunction in Asian patients.

OBJECTIVE: This study aimed to use validated measures to evaluate the functional and esthetic outcomes in patients who underwent functional rhinoplasty for Internal Nasal Valve Dysfunction (INVD) in Korea. METHODS: A retrospective review of consecutive patients who underwent functional rhinoplasty for INVD confirmed by endoscopic findings and the modified Cottle test between 2016 and 2018 was performed. Nasal obstruction was assessed with the Visual Analog Scale (VAS) and nasal obstruction symptom evaluation (NOSE) scale. Acoustic rhinometry was performed pre- and post-operatively. The Minimal Cross-Sectional Area (MCA) of the nose was measured. Objective assessment of the esthetic outcomes was performed with the Objective Rhinoplasty Outcome Score (OROS), which assesses tip rotation, projection, width, dorsal height, width, length, symmetry, and the overall result. RESULTS: Fifty-seven patients (46 men and 11 women; mean age, 30.5 ±â€¯12.3 years) who underwent functional rhinoplasty were included in this study. The VAS and NOSE scores indicated functional improvement in all cases (all p < 0.001). There were no significant between-group differences (VAS score, p = 0.274; NOSE score, p = 0.952). The objective functional outcomes evaluated using MCA on the concave (p = 0.478) and convex (p = 0.631) sides did not differ significantly pre- and post-operatively. The subjective evaluation of esthetic satisfaction revealed no between-group difference. Moreover, 31 out of 44 patients (70.5%) with static INVD and nine out of 14 patients (64.3%) with dynamic or combined INVD showed excellent outcomes. Regarding objective esthetic outcomes, scores for the eight factors were >3, and there was no significant difference between the two groups (all p > 0.05). CONCLUSIONS: Functional rhinoplasty, including extracorporeal septoplasty and spreader grafting, may be a viable option for correcting INVD with functional and esthetic improvement. Dynamic INVD is less prevalent among Asians, and there was no significant difference in the surgical outcomes compared with those of static INVD. LEVEL OF EVIDENCE: Level 4.

Quality of Life of Chronic Heart Failure Patients During and After COVID-19: Observational Study Using EuroQoL-Visual Analogue Scales.

BACKGROUND Chronic diseases affect both the mental and physical health of patients. An acute infection can further deteriorate it. The multi-organ damage and acute respiratory distress caused by coronavirus leads to worsening of the previously stable state of chronic diseases. MATERIAL AND METHODS The aim of our study was to compare the quality of life during pre-acute-post-COVID-19 infection status of chronic heart failure (CHF) patients based on responses on the EuroQoL-visual analogue scales (EQ VAS). Patients suffering from CHF and a COVID-19 infection were included in our study. EuroQoL questionnaires responses were recorded at 3 time-points (Q1 before COVID-19 infection, Q2 during an acute episode of COVID-19, and Q3 at 6 months after COVID infection). The statistical analysis was carried out both in a cross-sectional view for each time-point and longitudinally. The non-parametric Mann-Whitney test for independent series was applied in the case of subgroup comparison, and the Wilcoxon signed ranks test was used in the longitudinal study. RESULTS Based on the responses given by the patients, there was decline in QoL noted in all patients, mainly in females, included in our study during the acute phase of the infection, as compared to their pre-COVID-19 admission for a follow-up for their heart disease (Q1: 78.89 vs Q2: 66.11 in males and Q1: 71.54 vs Q2: 49.6 in females, p=0.015 for Q2). Improvement was noted in the evaluation done after 6 months to the acute episode, although the values failed to attain to that of the initial pre-COVID-19 analysis, with Q3: 71.92 in males and 70.56 in females. CONCLUSIONS Understanding these implications can guide healthcare interventions for better management and support, particularly in the context of pre-existing chronic conditions exacerbated by acute infections like COVID-19. The results may prompt further research into the long-term effects of COVID-19 on individuals with chronic diseases, guiding future studies to explore specific interventions or preventive measures. QoL during the acute phase of COVID-19 infection is affected on a larger extent as compared to previous analysis in chronic heart failure patients. Larger studies with a longer time span can indicate the time duration required for CHF patients to attain the pre-COVID-19 QoL status. Developing methods to increase the accuracy of QoL evaluation can further reduce the bias witnessed, especially in previously unhealthy subjects. The study’s findings could inform healthcare providers about the heightened risk and specific challenges faced by chronic heart failure patients during and after a COVID-19 infection. Policymakers can use these findings to develop targeted public health policies aimed at protecting and supporting individuals with chronic conditions during and after infectious outbreaks, ensuring comprehensive healthcare strategies.

[Comparison of pain intensity measurements among patients with low-back pain]. / A fájdalom intenzitását méro skálák összehasonlítása ágyéki gerincfájdalommal élok körében.

Background and purpose:

Pain intensity is the most frequently assessed health domain in clinical studies among patients with low-back pain. Visual analogue scale (VAS) and Numeric rating scale (NRS) have been the mostly used measurement tools for pain intensity. We proposed to correlate these instruments to a generic health-related quality of life measurement tool in order to show the scale with superior clinical relevance.

We used cross-sectional, convenience sampling. 120 patients with chronic low-back pain administered the 29-item Patient Reported Outcomes Measurement Information System Profile with NRS included, and the VAS scale in the National Institute of Mental Health, Neurology and Neurosurgery. We determined the correlation between PROMIS domain T-scores and VAS and NRS scores.

We performed Spearman rank correlation test to calculate the correlation coefficient. We found VAS scales measuring pain had weak to moderate correlations with all PROMIS health domains (r = 0.24–0.55). Therefore, we compared correlation of PROMIS domain scores with PROMIS pain intensity numeric rating scale and VAS scales. PROMIS domains had moderate to strong correlations with pain intensity scale (r = 0.45–0.71). PROMIS physical function short form [r = –0.65, 95% CI (–0.75) – (–0.55)] and PROMIS pain interference short form (r = 0.71, 95% CI 0.63 – 0.79) had the strongest correlation with pain intensity item.

NRS has showed greater correlation with PROMIS domain T-scores than VAS scale. This may prove that NRS has greater connection to another health domains, thus it correlated more to health-related quality of life than visual scale. We recommend NRS to use in further clinical studies conducted among patients with low-back pain.

Health-related quality of life measured using the EQ-5D-3L: iranian population norms.

BACKGROUND: Normative values are valuable for comparing a specific population with the general population, making them particularly useful in disease burden studies and cost-effectiveness analysis. The objective of this study was to estimate HRQoL normative values for the EQ-5D measure in Iran. METHODS: The analysis was performed using a sample (n = 27,704) of the Iranian adult population, which was extracted from a nationwide survey conducted in 2021. Participants assessed their health-related quality of life using the EQ-5D-3 L instrument and a visual analogue scale (EQ VAS). Multivariable regression analyses were performed to examine the relationships between utility scores, EQ VAS scores, and various socio-demographic factors. RESULTS: The mean utility and EQ VAS scores of the total sample were 0.87 (95% CI: 0.86, 0.88) and 72.9 (95% CI: 72.7, 73.1), respectively. Almost half of the respondents (46.8%) reported a health state without any problems. The most prevalent problems were pain/discomfort (38.3%) and anxiety/depression (35.2%). Furthermore, EQ-5D values and EQ VAS scores were associated with gender, age, employment status, education level, marital status, and chronic illness. CONCLUSIONS: This study provided normative values for the general population in Iran. Policymakers and researchers can use these values as a reference for population norms in economic assessments and studies focusing on the population's health.

Validation of the Distress Thermometer as a Screening Tool for Psychosocial Distress and Resilience in Parkinson's Disease.

BACKGROUND: Parkinson's disease (PD) is associated with psychosocial distress that affects patients' quality of life. The distress thermometer (DT) is an 11-point visual analogue scale that is used as a screening tool for the assessment of psychosocial distress, originally developed for oncological diseases. OBJECTIVES: To validate the DT for PD and to explore contributing factors. METHODS: The DT scale was administered to 105 people with Parkinson's Disease (PwPD). Along with it, we assessed motor symptoms (Unified Parkinson's Disease Rating Scale part III [UPDRS III], Hoehn and Yahr-stage [H&Y]), non-motor symptoms (Non-motor Symptom Questionnaire [NMSQ]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS], Fear of Progression-Questionnaire Short Form [FOP-Q-SF], Generalized Anxiety Disorder Scale-7 [GAD-7], 9-question Patient Health Questionnaire [PHQ-9]), the feeling of hope (Herth Hope Index [HHI]) and quality of life (Schedule for the Evaluation of Individual Quality of Life [SEIQoL]). RESULTS: With a cut-off of 4, the DT identified PwPD with distress with a sensitivity of 97% and a specificity of 38%. With this cut-off, the DT will yield false negative results in 1 out of 100 cases. Factor analyses and a random forest regression of the dataset revealed that distress can be predicted by two factors, which we termed "anxiety" and "depression/resilience/motor symptoms". CONCLUSION: The DT is an ultra-short and reliable screening tool for distress in PwPD. DT values below 4 rule out distress with a high degree of certainty. Anxiety and depression are important factors in distress but are counterbalanced by the individuals' psychological resilience.

Pre- and post-treatment in flexor tendon tenolysis: An observational study.

BACKGROUND: Glide deficit of the distal flexors' tendons following primary repair in zone 1-3 are very common. Adhesions of tendons have multi factorial origins and are closely related to the healing of the affected tissues. The surgical practice used to resolve these complications is tenolysis. PURPOSE: The purpose of this study was to identify and compare the Visual Analog Scale (VAS) relate to pain and Total Active Motion (TAM) of adult patients of both sexes undergoing tenolysis surgery. The results will then be compared to existing research to confirm their significance. STUDY DESIGN: Case-series. METHODS: Retrospective data for TAM and pain VAS were extracted from the medical records for 63 patients (73 fingers) who underwent flexor tenolysis between 2017 and 2019. Data were compared pre-operatively and 3 months after surgery. All patients underwent pre- and post-surgery therapy by hand therapists. RESULTS: The sample presented very encouraging improvements, except in the VAS and active range of motion (AROM) of thumb where some patients maintained the same assessment. The fingers reported statistically significant results, whereas the thumb group did not meet significant criteria. Overall, TAM improved from 134.6° to 196.7 and VAS decreased from 2.7 to 1.2. DISCUSSION: According to the results and the data change between pre- and post-treatment, the sample demonstrated improvements in all areas examined, reporting statistically significant results for the fingers with an improvement of TAM of 62.1° with a percentage value (%TAM) of 75.6%. CONCLUSIONS: A specific treatment for this type of surgery is required for the patients so they can return to their daily and working activities. This article can be used as a starting point for further studies.

Validation of a Dyspnea Visual Analog Scale in Fibrotic Interstitial Lung Disease.

Rationale: A visual analog scale (VAS) is a simple and easily administered tool for measuring the impact of disease; however, little is known about the use of a dyspnea VAS in interstitial lung disease (ILD). Objectives: To validate the use of a dyspnea VAS in a large and heterogeneous cohort of patients with fibrotic ILD, including its minimal clinically important difference (MCID), responsiveness to change, and prognostic significance. Methods: Patients with fibrotic ILD were identified from a large prospective registry. The validity of a 100-mm dyspnea VAS was assessed by testing its correlation in change score with other measures of ILD severity, including the University of California San Diego Shortness of Breath Questionnaire, the King's Brief Interstitial Lung Disease quality of life questionnaire Breathlessness and Activities Domain, the European Quality of Life VAS, forced vital capacity, and diffusing capacity of the lung for carbon monoxide. The responsiveness of the dyspnea VAS was qualitatively confirmed on the basis of there being an observable difference in the change in dyspnea VAS across tertiles of change in anchor variables. The MCID in dyspnea VAS was calculated using both anchor (linear regression) and distribution (one-half standard deviation) approaches, with anchors including the above variables that had a correlation with dyspnea VAS (|r| ≥ 0.30). The association of dyspnea VAS with time to death or transplant was determined. Results: The cohort included 826 patients with fibrotic ILD, including 127 patients with follow-up measurements at 6 months. The mean baseline dyspnea VAS was 53 ± 24 mm. Dyspnea VAS change scores were moderately correlated with the University of California San Diego Shortness of Breath Questionnaire (|r| = 0.55) and the King's Brief Interstitial Lung Disease quality of life questionnaire Breathlessness and Activities Domain (|r| = 0.44) and weakly correlated with the European Quality of Life VAS (|r| = 0.19), forced vital capacity percent predicted (|r| = 0.21), and diffusing capacity of the lung for carbon monoxide percent predicted (|r| = 0.05). The MCID was 2.7 to 4.5 using the more reliable anchor-based methods and 12.0 based on distribution-based methods. Dyspnea VAS was associated with time to death or transplant in unadjusted models and after adjustment for age and sex (hazard ratios, 1.16 and 1.15, respectively; P < 0.05 for both). Conclusions: This study provides support for the use of the dyspnea VAS in patients with fibrotic ILD, with an estimated anchor-based MCID of 5 mm.

Psychometric validation of the Psoriasis Symptom Scale, Functional Assessment of Chronic Illness Therapy-Fatigue and pain-Visual Analogue Scale in patients with generalized pustular psoriasis.

BACKGROUND: Generalized pustular psoriasis (GPP) is a rare, chronic, inflammatory skin disease associated with considerable patient burden. The Psoriasis Symptom Scale (PSS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and pain-Visual Analogue Scale (pain-VAS) are patient-reported outcomes (PROs) that have not yet been validated in patients with GPP. OBJECTIVES: To evaluate the psychometric properties of the PSS, FACIT-Fatigue and pain-VAS using data from Effisayil 1, a randomised trial of spesolimab in patients with moderate-to-severe GPP. METHODS: Inter-item correlations and confirmatory factor analysis (CFA) were performed using Week 1 data. Internal consistency was assessed with Cronbach's α coefficient using baseline and Week 1 data. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs); change data for the GPP Physician Global Assessment total score and pustulation subscore were used to define a stable population. Convergent validity was assessed at baseline and Week 1 using Spearman's rank-order correlations. Known-groups validity was measured by analysis of variance using Week 1 data. Ability to detect change from baseline to Week 1 was evaluated by analysis of covariance. RESULTS: Inter-item and item-to-total correlations were moderate or strong for most PSS and FACIT-Fatigue items. CFA demonstrated the unidimensionality of the PSS and FACIT-Fatigue, with high factor loadings for most items (PSS range, 0.75-0.94; FACIT-Fatigue range, 0.11-0.93) and acceptable fit statistics. Both scores demonstrated internal consistency (Cronbach's α, 0.71 and 0.95, respectively). The PSS, FACIT-Fatigue and pain-VAS demonstrated test-retest reliability (ICCs ≥0.70) and good evidence of convergent validity. Furthermore, the PROs could differentiate between known groups of varying symptom severity (range, p < 0.0001-0.0225) and detect changes in symptom severity from baseline to Week 1 (range, p < 0.0001-0.0002). CONCLUSIONS: Overall, these results support the reliability, validity and ability to detect change of the PSS, FACIT-Fatigue and pain-VAS as PROs in patients with GPP.

Measurements of Electrodermal Activity, Tissue Oxygen Saturation, and Visual Analog Scale for Different Cuff Pressures.

The quantification of comfort in binding parts, essential human-machine interfaces (HMI) for the functioning of rehabilitation robots, is necessary to reduce physical strain on the user despite great achievements in their structure and control. This study aims to investigate the physiological impacts of binding parts by measuring electrodermal activity (EDA) and tissue oxygen saturation (StO2). In Experiment 1, EDA was measured from 13 healthy subjects under three different pressure conditions (10, 20, and 30 kPa) for 1 min using a pneumatic cuff on the right thigh. In Experiment 2, EDA and StO2 were measured from 10 healthy subjects for 5 min. To analyze the correlation between EDA parameters and the decrease in StO2, a survey using the visual analog scale (VAS) was conducted to assess the level of discomfort at each pressure. The EDA signal was decomposed into phasic and tonic components, and the EDA parameters were extracted from these two components. RM ANOVA and a post hoc paired t-test were used to determine significant differences in parameters as the pressure increased. The results showed that EDA parameters and the decrease in StO2 significantly increased with the pressure increase. Among the extracted parameters, the decrease in StO2 and the mean SCL proved to be effective indicators. Such analysis outcomes would be highly beneficial for studies focusing on the comfort assessment of the binding parts of rehabilitation robots.