Health-related quality of life in primary care patients: a comparison between EQ-5D-5L utility score and EQ-visual analogue scale.

OBJECTIVE: The EQ-VAS is an important component of the EQ-5D questionnaire. However, there is limited evidence comparing its performance to the EQ-5D utility score, which restricts its use in the population. This study aimed to EQ-5D-5L utility score and EQ-visual analogue scale (EQ-VAS) in primary care patients in Hong Kong (HK). METHODS: Secondary data analysis was performed on the data collected from a cross-sectional survey to investigate patient engagement in HK. Participants were recruited through random sampling from a single general outpatient clinic. Trained investigators conducted face-to-face interviews with all eligible patients attending the clinic. Patients who were: 1) ≥ 18 years old, 2) have visited the clinic at least once in the last 6 months, 3) no cognitive problems, and 4) can speak and understand the local language. Pearson correlation was used to explore the association between EQ-5D utility and EQ-VAS score. Ordinary least squares regression and heteroscedastic Tobit regression models were adopted to analyze the EQ-VAS and EQ-5D utility data, respectively. RESULTS: The analysis included data from 1,004 responses (response rate = 65%). Around 52.7% of participants were female, 25.9% completed tertiary or above education, and 75.1% living with chronic disease. The mean EQ-5D utility and EQ-VAS score were 0.92 (SD = 0.13) and 72.27 (SD = 14.69), respectively. A significant association was found between EQ-5D utility and EQ-VAS score, with coefficients ranging from 0.335 (participants who divorced) to 0.744 (participants living alone). Around 98.5% reported having no problems with 'Self-care', followed by 'Usual activities' (96.3%), 'Mobility' (91.5%) and 'Anxiety/depression' (79.9%). The correlation between EQ-VAS score and EQ-5D utility was positive for each dimension of the EQ-5D instrument (correlation coefficients ranged between 0.211 and 0.623). Age strongly influenced the magnitude and trajectory of EQ-VAS score and utility, as observed in the changes. The regression model showed that 'Mobility', 'Pain/discomfort', and 'Anxiety/depression' have considerable influence on EQ-VAS score. CONCLUSIONS: This study compared the EQ-5D utility score and EQ-VAS in HK primary care setting. Although heterogeneity existed, the EQ-VAS and utility score are significantly correlated and reliable for evaluating health-related quality of life in this population.

In symptomatic patients on as-needed inhaled corticosteroids-formoterol, VAS asthma is associated with small airways resistance.

OBJECTIVES: Impulse oscillometry (IOS) can demonstrate small airways disease even when spirometry values are normal. However, it is unknown if the absence of symptoms excludes increased small airways resistance in asthma patients. We aimed to correlate symptoms (assessed through visual analogue scales) with measures of small airways resistance in patients with asthma and to determine whether less symptomatic patients have increased small airways resistance. METHODS: We conducted a single center, prospective cohort study. We included controlled asthma patients on as-needed inhaled corticosteroids-formoterol. Patients were evaluated on their symptom VASs, Spirometry and IOS (with R5-R20% measuring small airways resistance) which were measured both in periods when they were less symptomatic and symptomatic. Symptoms were assessed using MASK-air®, an mHealth app that includes a daily monitoring questionnaire with validated VASs. We correlated MASK-air VASs with small airways resistance. RESULTS: We assessed 29 patients. There was a significant correlation between VAS asthma and R5-R20% in symptomatic periods (r = 0.43; 95% CI = 0.13;0.68, p = 0.019), but not in less symptomatic periods (0.04; 95% CI-0.40;0.46; p = 0.825). In less symptomatic periods, patients presenting with low VAS asthma (VAS < 30) displayed a lower median R5-R20% than the remainder (0.26 versus 0.35), as well as a lower R5% (0.13 versus 0.15) (p < 0.001). In 68.9% of less symptomatic patients, R5-R20 values remained higher than normal values. CONCLUSION: In symptomatic patients on as-needed inhaled corticosteroids-formoterol, VAS asthma was associated with small airways resistance. However, even if these patients are less symptomatic, small airways resistance may be higher than normal. Since SAD significantly affects asthma control, patients should be carefully followed-up, even in less symptomatic periods.

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.

The level of agreement between the numerical rating scale and visual analogue scale for assessing pain intensity in adults with chronic pain.

The numerical rating scale and visual analogue scale are used to quantify pain intensity. However, it has not yet been explored whether these scores are interchangeable in adults with chronic pain. Data from the prospective multicentre cross-sectional INTERVAL study were used to evaluate the one-dimensionality and agreement between numerical rating scale scores and visual analogue scale scores in adults with chronic pain. Pain intensity scores using the numerical rating scale and visual analogue scale were provided by 366 patients with chronic pain for current, average, minimal and maximal pain. To evaluate whether pain intensity scales are completed in accordance with each other, the proportion of patients who satisfied the following condition was calculated: minimal pain intensity ≤ maximal pain intensity. A factor analysis confirmed the one-dimensionality of the pain measures. A significant difference was found between numerical rating scale and visual analogue scale scores for average, current, minimum and maximum pain. Intra-class correlation coefficient estimates ranged from 0.739 to 0.858 and all measures failed to show sufficient and acceptable agreement at the 95% level. The strength of agreement between pain severity categories was classified as 'moderate' for average and minimal pain and 'substantial' for current and maximal pain. The proportion of patients who scored minimal pain ≤ maximal pain was 97.5% for the numerical rating scale and 89.5% for the visual analogue scale. This study failed to show an acceptable agreement between the numerical rating scale and visual analogue scale when pain intensity was rated by adults with chronic pain, despite showing both scales measure the same information.

Comparing pain intensity rating scales in acute postoperative pain: boundary values and category disagreements.

Pain intensity assessment scales are important in evaluating postoperative pain and guiding management. Different scales can be used for patients to self-report their pain, but research determining cut points between mild, moderate and severe pain has been limited to studies with < 1500 patients. We examined 13,017 simultaneous acute postoperative pain ratings from 913 patients taken at rest and on activity, between 4 h and 48 h following surgery using both a verbal rating scale (no, mild, moderate or severe pain) and 0-100 mm visual analogue scale. We determined the best cut points on the visual analogue scale between mild and moderate pain as 35 mm, and moderate and severe pain as 80 mm. These remained consistent for pain at rest and on activity, and over time. We also explored the presence of category disagreements, defined as patients verbally describing no or mild pain scored above the mild/moderate cut point on the visual analogue scale, and patients verbally describing moderate or severe pain scored below the mild/moderate cut point on the visual analogue scale. Using 30 and 60 mm cut points, 1533 observations (12%) showed a category disagreement and using 35 and 80 mm cut points, 1632 (13%) showed a category disagreement. Around 1 in 8 simultaneous pain scores implausibly disagreed, possibly resulting in incorrect pain reporting. The reasons are not known but low rates of literacy and numeracy may be contributing factors. Understanding these disagreements between pain scales is important for pain research and medical practice.

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.

The visual analogue scale as a child-friendly measure of the unhealthy = tasty intuition.

Worldwide, obesity is a growing concern. The implicit belief that healthiness and tastiness in food are inversely related (the Unhealthy = Tasty Intuition or UTI) decreases healthy food consumption and increases the risk of obesity. Since also childhood obesity has increased at an alarming rate and a large component of adult obesity is established during childhood, questions about children's own food beliefs and preferences are important. However, methods currently used to assess the UTI are either unvalidated Likert scales or implicit measures that are time intensive and too complex to be used for children. Two studies presented here offer an alternative measurement - the simple visual analogue scale. The findings show that this measure is more effective in predicting dietary quality in adults and the frequency of healthy food consumption in children compared to more traditional measures. This simple and effective tool could be used by academics and health practitioners alike to better understand children's food beliefs at an early age, which is a critical step when addressing the increasing obesity problem.

Comparison and interobserver reliability between a visual analog scale and the Wisconsin Calf Health Scoring Chart for detection of respiratory disease in dairy calves.

Respiratory disease is an ongoing challenge for calves in the dairy sector with a relatively high prevalence and impact on welfare and economics. Applying scoring protocols for detecting respiratory disease requires that they are easily implemented, consistent between observers and fast to use in daily management. This study was conducted in one Danish dairy farm from September 2020 through January 2021. The study included 126 heifer calves enrolled in the age of 17 to 24 d. All calves were observed every second day for a period of 46 d. At each visit all calves were scored with a new visual analog scale (VAS) and the Wisconsin Calf Health Scoring Chart (WCHSC). We calculated agreement between the 2 scoring systems based on conditional probability to score higher or lower than a cutoff in the VAS compared with a specified cutoff in WCHSC used as reference test. A generalized mixed effects regression model was developed to estimate the prevalence of respiratory disease and the overall agreement between the 2 scoring systems. The overall agreement between the VAS and WCHSC was 89.6%. The second part of the study assessed interobserver reliability between 2 experienced observers and between an experienced observer and veterinary students. The interobserver reliability was calculated by intraclass correlation coefficient and was 0.58 between experienced observers and was 0.34 between an experienced observer and veterinary students indicating a moderate to poor reliability between the observers. It was possible to use VAS as an alternative clinical scoring method, which primarily focuses on the general condition of the individual calf rather than specific categories of clinical signs. Our study set up lacked a comparison to other diagnostic tools i.e., thoracic ultrasound to confirm the findings which should be considered in future studies when exploring VAS as a screening tool for detection of respiratory disease in dairy calves.

Defining the Percent Thresholds for Achieving the Maximum Outcome Improvement of the Modified Harris Hip Score, the Non-Arthritic Hip Score, the Hip Outcome Score-Sports Subscale, the Visual Analog Scale for Pain, and the International Hip Outcome Tool-12 in Revision Hip Arthroscopy at Minimum 2-Year Follow-Up.

PURPOSE: To determine the respective percent thresholds for achieving the maximal outcome improvement (MOI) for the modified Harris Hip Score (mHHS), the Non-Arthritic Hip Score (NAHS), the Hip Outcome Score-Sports Subscale (HOS-SSS), the visual analog scale (VAS) for pain, and the International Hip Outcome Tool-12 (iHOT-12) that were associated with satisfaction following revision hip arthroscopy, and to identify predictors for achieving the MOI. METHODS: An anchor question was provided to patients who underwent revision hip arthroscopy between April 2017 and July 2020. Patients were included for the final analysis if they answered the anchor question and had minimum 2-year follow-up. Receiver operating characteristic analysis was used to determine the thresholds for the percentage of the MOI predictive of satisfaction. A P-value of < .05 was considered significant. RESULTS: In total, 318 patients underwent revision hip arthroscopy. Of those patients, 292 (91.8%) had minimum 2-year follow-up. Of this cohort, 68 answered the anchor question, with 49 (72.1%) female and 19 (27.9%) male patients. The mean age, and body mass index time were 32.9 ± 13 years and 25.4 ± 5.1, respectively. It was determined that 42.1%, 50%, 48.1%, 50%, and 50% of MOI were the thresholds for maximal predictability of satisfaction for mHHS, NAHS, HOS-SS, VAS for pain, and the iHOT-12, respectively. The presence of unaddressed subspine impingement was a significant predictor for achieving the MOI threshold for the VAS (odds ratio 1.40; 95% confidence interval 1.00-1.95; P = 0.0273). CONCLUSIONS: Following revision hip arthroscopy, the percent thresholds for achieving the MOI at a minimum 2-year follow-up for the mHHS, NAHS, HOS-SS, VAS for pain, and iHOT-12 were 42.1%, 50%, 48.1%, 50%, and 50.9%, respectively. Addressing residual subspine impingement was identified as significant positive predictor for achieving the MOI. LEVEL OF EVIDENCE: Level IV, case-series.

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).

Skin Prick Automated Test device offers more reliable allergy test results compared to a manual skin prick test.

BACKGROUND: The skin prick test (SPT) is the gold standard for identifying allergic sensitization in individuals suspected of inhalant allergy. A novel device, SPAT or Skin Prick Automated Test, that enables more standardized allergy testing has been developed. Previous research has shown reduced intra-subject variability of histamine wheals by SPAT. OBJECTIVE: This study aimed to evaluate within-test agreement (% of patients with consistent test results) to detect sensitization to common inhalant allergens when a SPT is executed automated by SPAT or by manual SPT (SPMT) procedure. METHODS: The 110 volunteers prospectively enrolled underwent both SPAT and SPMT with 3 pricks of house dust mite, timothy grass and birch, 2 pricks of histamine and 1 prick of glycerol. The proportion of consistent (3x positive â€" 3 x negative) and inconsistent (2x positive/negative â€" 1x positive/negative) test results were analysed. RESULTS: The proportion of inconsistent test results was significantly lower in the SPAT compared to the SPMT group. The delta histamine to control pricks was significantly higher in SPAT compared to SPMT group. Coefficient of variation was lower in SPAT compared to SPMT for house dust mite, timothy grass, birch pollen. Visual analogue scale for discomfort was significantly lower in SPAT compared to SPMT group. CONCLUSION: SPAT showed a 34% reduction in the number of inconsistent test results compared to manual SPT with common inhalant allergens. Patient experience is significantly improved when an allergy test is performed by SPAT compared to a manual SPT.

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.

[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.

What's the clinical significance of VAS, AOFAS, and SF-36 in progressive collapsing foot deformity.

BACKGROUND: This study aimed to ascertain the minimal clinically important difference (MCID), and substantial clinical benefit (SCB) of the American Orthopedic Foot and Ankle Society (AOFAS) scale, visual analog scale (VAS) for pain, and Short Form-36 Health Survey (SF-36) in progressive collapsing foot deformity (PCFD) surgery. METHODS: In this retrospective cohort study, a total of 84 patients with PCFD (84 feet) who underwent surgery between July 2015 and April 2021 were included. The study assessed the patients' subjective perception, as well as their VAS, AOFAS, and SF-36 scores at a minimum two-year follow-up, and these data were subjected to statistical analysis. The study utilized Spearman correlation analysis to determine the degree of correlation between patients' subjective perception and their VAS, AOFAS, and SF-36 scores. The minimal detectable change (MDC), MCID, and SCB for VAS, AOFAS, and SF-36 were calculated using both distribution- and anchor-based methods. The classification outcomes obtained from the distribution- and anchor-based methods were assessed using Cohen's kappa. RESULTS: Based on the subjective perception of the patients, a total of 84 individuals were categorized into three groups, with 7 in the no improvement group, 14 in the minimum improvement group, and 63 in the substantial improvement group. Spearman's correlation analysis indicated that the patients' subjective perception exhibited a moderate to strong association with VAS, AOFAS, SF-36 PCS, and SF-36 MCS, with all coefficients exceeding 0.4. The MCID of VAS, AOFAS, SF-36 PCS, and SF-36 MCS in PCFD surgery were determined to be 0.93, 5.84, 4.15, and 4.10 points using the distribution-based method and 1.50, 10.50, 8.34, and 3.03 points using the anchor-based method. The SCB of VAS, AOFAS, SF-36 PCS, and SF-36 MCS in PCFD surgery were 2.50, 18.50, 11.88, and 6.34 points, respectively. Moreover, the preliminary internal validation efforts have demonstrated the practical application and clinical utility of these findings. With the exception of the distribution-based MCID of SF-36 PCS, which showed fair agreement, all other measures demonstrated moderate to almost perfect agreement. CONCLUSIONS: The MDC, MCID, and SCB intuitively enhance the interpretation of VAS, AOFAS, and SF-36 in PCFD surgery, assisting all stakeholders to better understand the therapeutic benefits and limitations of clinical care, and thus to make a more rational decision. Each of these parameters has its own emphasis and complements the others. These parameters are recommended for evaluating the clinical relevance of the results, and their promotion should extend to other areas of foot and ankle surgery.

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus.

BACKGROUND: Nemolizumab is a subcutaneously administered humanized monoclonal antibody against interleukin-31 receptor A, which is involved in pruritus and inflammation in atopic dermatitis. In phase 2 studies, nemolizumab lessened the severity of atopic dermatitis. METHODS: In a 16-week, double-blind, phase 3 trial, we randomly assigned Japanese patients with atopic dermatitis and moderate-to-severe pruritus and an inadequate response to topical agents in a 2:1 ratio to receive subcutaneous nemolizumab (60 mg) or placebo every 4 weeks until week 16, with concomitant topical agents. The primary end point was the mean percent change in the visual-analogue scale (VAS) score for pruritus (range, 0 to 100, with higher scores indicating worse pruritus) from baseline to week 16. Secondary end points included the time course of change in the VAS score for pruritus up to week 4, the change in the Eczema Area and Severity Index (EASI) score (range, 0 to 72, with higher scores indicating greater severity), a score of 4 or less on the Dermatology Life Quality Index (DLQI; range, 0 to 30, with higher scores indicating a greater effect on daily life), a score of 7 or less on the Insomnia Severity Index (ISI; range, 0 to 28, with higher scores indicating greater severity), and safety. RESULTS: A total of 143 patients were randomly assigned to receive nemolizumab and 72 to receive placebo. The median VAS score for pruritus at baseline was 75. At week 16, the mean percent change in the VAS score was -42.8% in the nemolizumab group and -21.4% in the placebo group (difference, -21.5 percentage points; 95% confidence interval, -30.2 to -12.7; P<0.001). The mean percent change in the EASI score was -45.9% with nemolizumab and -33.2% with placebo. The percentage of patients with a DLQI score of 4 or less was 40% in the nemolizumab group and 22% in the placebo group; the percentage of patients with an ISI score of 7 or less was 55% and 21%, respectively. The incidence of injection-related reactions was 8% with nemolizumab and 3% with placebo. CONCLUSIONS: In this 16-week trial, the use of subcutaneous nemolizumab in addition to topical agents for atopic dermatitis resulted in a greater reduction in pruritus than placebo plus topical agents. The incidence of injection-site reactions was greater with nemolizumab than with placebo. Longer and larger trials are necessary to determine whether nemolizumab has a durable effect and is safe for atopic dermatitis. (Funded by Maruho; JapicCTI number, 173740.).

How Does Pregnancy and Type of Delivery Affect the Clinical Course of Hereditary Angioedema?

INTRODUCTION: Knowledge on the clinical course of hereditary angioedema (HAE) during pregnancy, delivery, and breastfeeding is very limited. In this study, we aimed to evaluate the course of HAE during these periods. METHODS: The HAE attacks C1-INH prophylaxis before and during pregnancy and during breastfeeding, and the delivery types were retrospectively determined. The severity of attacks was assessed by a 10-point Visual Analogue Scale (VAS). RESULTS: We evaluated 88 pregnancies in 48 HAE patients among whom 20 were primiparous. Among those who had a HAE diagnosis during pregnancy (n = 34), the median attack numbers before pregnancy, during pregnancy, breastfeeding, and after breastfeeding were 17, 39, 24, and 14 (before pregnancy vs. pregnancy, p < 0.001; during pregnancy vs. breastfeeding, p = 0.001). The mean VASs (SD) were 6.59 (1.82), 8.33 (1.58), 7.32 (1.66), and 6.95 (1.90) (before pregnancy vs. pregnancy, p < 0.001; during pregnancy vs. breastfeeding, p = 0.016), respectively. Among those who received a HAE diagnosis after pregnancy (n = 54), the number (59.3%) and the severity (60%) of HAE attacks were high in pregnancy. 47 of the deliveries were normal vaginal delivery (NVD). Regional anesthesia was applied in 8 NVDs. 20 of caesarean deliveries were performed under general anesthesia, and 21 were under spinal anesthesia. Lowest numbers of attacks were found in patients who did not receive anesthesia during NVD (p = 0.001). CONCLUSION: The course of HAE can be worse during pregnancy and breastfeeding. NVD is related to fewer HAE attacks and prophylaxis with C1-INH during NVD is not necessary to prevent a HAE attack.

A Visual Analog Scale for Self-Reported Quality of Life: A Comparison of VAS and QoL-AD in Older Adults.

PURPOSE: People with dementia (PWD) are one of the fastest-growing clinical populations for speech-language pathologists. Self-reported quality of life (QoL) assessments are critical patient-reported outcome measures that align with person-centered care principles. However, proxy-reporting is most often used due to assumptions that PWD cannot provide reliable self-report. Visual analog scales (VASs) have been successfully used with people with expressive and cognitive deficits to measure subjective constructs such as QoL, mood, and pain. The purpose of this project is to evaluate the feasibility and reliability of a VAS QoL assessment tool. METHODS: Twenty older adults free of cognitive impairment were assessed using the quality of life in Alzheimer's disease (QoL-AD) and the QoL-AD in combination with a VAS (VAS QoL-AD). The construct validity, internal consistency, and test-retest reliability of the VAS QoL-AD were assessed by performing both assessments twice, 4 weeks apart. RESULTS: Significant correlations between the overall VAS QoL-AD and the QoL-AD scale ratings, between most of the QoL-AD and VAS QoL-AD subtests, and between the first and second assessment scores were observed. CONCLUSIONS: Results indicated strong construct validity, internal consistency, and test-retest reliability of the VAS QoL-AD in people without dementia. These results warrant further research into the development of a dementia-specific, self-reported VAS QoL scale for PWD.

Evaluation of the EQ-5D-5L, EQ-VAS stand-alone component and Oxford knee score in the Australian knee arthroplasty population utilising minimally important difference, concurrent validity, predictive validity and responsiveness.

PURPOSE: To evaluate the Oxford Knee Score (OKS), EQ-5D-5L utility index and EQ-5D visual analogue scale (EQ-VAS) for health-related quality of life outcome measurement in patients undergoing elective total knee arthroplasty (TKA) surgery. METHODS: In this prospective multi-centre study, the OKS and EQ-5D-5L index scores were collected preoperatively, six weeks (6w) and six months (6 m) following TKA. The OKS, EQ-VAS and EQ-5D-5L index were evaluated for minimally important difference (MID), concurrent validity, predictive validity (Spearman's Rho of predicted and observed values from a generalised linear regression model (GLM)), responsiveness (effect size (ES) and standard response mean (SRM)). The MID for the individual patient was determined utilising two approaches; distribution-based and anchor-based. RESULTS: 533 patients were analysed. The EQ-5D-5L utility index showed good concurrent validity with the OKS (r = 0.72 preoperatively, 0.65 at 6w and 0.69 at 6 m). Predictive validity for the EQ-5D-5L index was lower than OKS when regressed. Responsiveness was large for all fields at 6w for the EQ-5D-5L and OKS (EQ-5D-5L ES 0.87, SRM 0.84; OKS ES 1.35, SRM 1.05) and 6 m (EQ-5D-5L index ES 1.31, SRM 0.95; OKS ES 1.69, SRM 1.59). The EQ-VAS returned poorer results, at 6w an ES of 0.37 (small) and SRM of 0.36 (small). At 6 m, the EQ-VAS had an ES of 0.59 (moderate) and SRM of 0.47 (small). It, however, had similar predictive validity to the OKS, and better than the EQ-5D-5L index. MID determined using anchor approach, was shown that for OKS at 6 weeks it was 8.84 ± 9.28 and at 6 months 13.37 ± 9.89. For the EQ-5D-5L index at 6 weeks MID was 0.23 ± 0.39, and at 6 months 0.26 ± 0.36. CONCLUSIONS: The EQ-5D-5L index score and the OKS demonstrate good concurrent validity. The EQ-5D-5L index demonstrated lower predictive validity at 6w, and 6 m than the OKS, and both PROMs had adequate responsiveness. The EQ-VAS had poorer responsiveness but better predictive validity than the EQ-5D-5L index. This article includes MID estimates for the Australian knee arthroplasty population.

Efficacy of Tailor-Made Notched Music Training Versus Tinnitus Retraining Therapy in Adults With Chronic Subjective Tinnitus: A Randomized Controlled Clinical Trial.

OBJECTIVES: Chronic subjective tinnitus can have a serious effect on daily life, even causing serious psychological disorders. Currently there are no specific effective solutions or cures. Tailor-made notched music training (TMNMT) is a recently proposed sound therapy that has simpler processes and a higher compliance rate than tinnitus retraining therapy (TRT), a widely used treatment for chronic subjective tinnitus. This study explores the therapeutic effect of TMNMT in comparison to TRT to highlight its clinical value. DESIGN: The study was a randomized controlled, single-blinded clinical trial. One hundred twenty eligible participants were randomly assigned to receive TMNMT (n = 60) or TRT (n = 60) for 3 mo with concurrent follow-up. It should be noted that the duration of sound treatment in TRT was modified to 2 hr per day for better feasibility in practice. The primary outcome was mean change in tinnitus handicap inventory (THI) measured at baseline ( T0 ), 1 mo ( T1 ) and 3 mo ( T2 ) after intervention. Change in visual analog scale (VAS) was measured as a secondary outcome. A comparison of therapeutic effectiveness between TMNMT and TRT was evaluated by repeated measure analysis of variance. RESULTS: One hundred and twelve (93%) of participants took part in the study, of which 64 were men and 48 women. Mean (SD) age was 42.80 (12.91) years. Fifty-eight were allocated to receive TMNMT and 54 to receive TRT. The between-group difference in primary outcome was -6.90 points (95% confidence interval [CI], -13.53 to -0.27) at T1 and -6.17 points (95% CI, -13.04 to 0.71) at T2 . These results closely reached to clinical significance of tinnitus-related effective relief. For the secondary outcome, the mean value in the TMNMT group was 0.83 points (95% CI, 0.12 to 1.54), significantly lower than the mean value of the TRT group. The differences in THI and VAS between the two groups were statistically significant after intervention. Further analysis showed that age and baseline THI and VAS scores were associated with change in THI and VAS scores after interventions. CONCLUSIONS: Both TMNMT and TRT were able to alleviate chronic subjective tinnitus effectively after a 3 month intervention. When the two forms of therapy were compared TMNMT appeared to be more effective and consequently potentially superior to TRT for reducing tinnitus loudness and functional and emotional disturbance associated with chronic subjective tinnitus.

Use of the visual analogue scale for health state valuation: a scoping review.

OBJECTIVES: The visual analogue scale (VAS) has been used in the context of health and healthcare for various purposes, for example, to measure pain and to provide a single-index measure of health-related quality of life (HRQoL). This scoping review aims to describe how the VAS has been used for health state valuation in the published literature. METHODS: The search was carried out in Medline, Web of Science and PsycInfo. The findings of the included articles were tabulated and presented descriptively using frequencies and proportions. RESULTS: The database search yielded 4856 unique articles, out of these, 308 were included. In 83% of the articles, the main purpose for using a VAS was to value health states. The two most common perspectives when valuing health states with a VAS were hypothetical (44%) and own health (34%). Some (n = 14) articles used the VAS in the context of economic evaluations, including calculating quality-adjusted life years (QALYs). A large variation in the design of the VAS was found, including the description of the lower and upper anchors. Advantages and disadvantages with using a VAS were mentioned in 14% of the included articles. CONCLUSION: The VAS has been a common method for valuing health states, both as a stand-alone method and in combination with other valuation methods. Despite its widespread use, the design of the VAS has been inconsistent which makes comparison of results across studies challenging. Further research on the role of using the VAS in economic evaluations is warranted.