US Scoring Research Articles

Magnetic resonance spectroscopy as a diagnostic model for assessment of liver steatosis in metabolic dysfunction-associated steatotic liver disease in non-diabetic patients

BackgroundMetabolic dysfunction-associated steatotic liver (MASLD) disease is the commonest hepatic cause of liver fibrosis and cirrhosis after the introduction of the direct acting antivirals and eradication of hepatitis C. MASLD is usually associated with metabolic syndrome and elevated inflammatory markers. Magnetic resonance spectroscopy (MRS) offers a non-invasive diagnostic, alternative to liver biopsy. This is a case–control diagnostic-accuracy study conducted on 40 patients in the Hepato-gastroenterology Unit in the Internal Medicine Department, Ain Shams University Hospitals, to study the role of MRI spectroscopy as a new diagnostic model for assessment of liver steatosis in non-diabetic MASLD patients compared to the standard ultrasound and clinical criteria. MASLD was diagnosed by a combination of a validated ultrasound hepatic steatosis score grading system and hepatic steatosis index using clinical and laboratory parameters. MRS was performed in all patients and fat peak, water peak, and fat fraction % were measured, and diagnostic accuracy of different MRS is compared to the US scoring and different laboratory and clinical parameters. To our knowledge this is the first study conducted on MRS in our region and Egypt.ResultsThis study revealed no statistically significant difference between the two groups regarding HbA1C, creatinine, while there was highly statistically significant difference regarding fasting blood sugar, 2 h post-prandial glucose level, urine albumin, and low-density lipoprotein levels. Hepatic steatosis score grading by abdominal ultrasound on the 20 controls showed no fatty changes with grade 0 (50%), and on the 20 MASLD patients showed that 2 cases were grade 1 steatosis (5%), 9 cases were grade 2 steatosis (22.5%), and 9 cases were grade 3 steatosis (22.5%). The diagnostic accuracy of predicting hepatic steatosis using different MRS parameters: fat peak, water peak, and fat fraction had area under the curve of 99.9%, 88.6%, and 100%, respectively. The sensitivity and specificity of fat fraction in detecting hepatic steatosis were 100%. The sensitivity and specificity of the fat peak in detecting hepatic steatosis were 100% and 95%, respectively. Moreover, the sensitivity and specificity of the water peak in detecting the hepatic steatosis were 88.6% and 85%, respectively. There is a statistically significant correlation between the three MRS parameters and the abdominal ultrasound hepatic steatosis score grades.ConclusionMRS parameters: fat fraction, fat peak, and water peak, have high diagnostic accuracy for predicting the liver steatosis. Moreover, MRS has the added advantage of being a non-invasive and a tool with low radiation risk. MRS also shows the metabolic changes in the liver and could be an eligible outcome in therapeutic clinical trials.

A post hoc comparative real-world analysis of HEAD-US score for joint health assessment of patients with severe haemophilia A and B in Spain.

Joint damage due to haemarthrosis can be effectively monitored with point-of care ultrasound using the Haemophilia Early Arthropathy Detection with US (HEAD-US) scoring system. A post hoc comparative analysis of the joint status of patients with severe haemophilia A (HA) or B (HB) was performed. The databases of two observational, cross-sectional studies that recruited patients with HA or HB from 12 Spanish centres were analysed to compare the status of the elbows, knees and ankles in patients with severe disease according to treatment modality. The HEAD-US score was calculated in both studies by the same trained operators. Overall, 95 HA and 41 HB severe patients were included, with a mean age of 35.2±11.8 and 32.7±14.2 years, respectively. The percentage of patients who received prophylaxis, over on-demand (OD) treatment, was much higher in HA (91.6%) than in HB (65.8%) patients. With a similar number of target joints, the HEAD-US score was zero in 6.3% HA and 22.0% HB patients (p<.01), respectively. The HA population showed significantly worse HEAD-US scores. Whilst osteochondral damage occurred more frequently in patients OD or tertiary prophylaxis, our data suggest that articular damage is less prominent in primary/secondary prophylaxis, regardless of the type of haemophilia. These latter treatment modalities were also associated with a lower prevalence of synovial hypertrophy, particularly in HB patients. This post hoc analysis indicates that joint status seems to be significantly influenced by haemophilia type (HA or HB) and treatment modality in these severe Spanish populations with severe disease. Continuing HEAD-US monitoring for the early detection and management of intra-articular abnormalities, as well as more efficiently tailored therapies should be warranted.

The diagnostic performance of ultrasound in the diagnosis of indeterminate adnexal masses based on the O-RADS US scoring system

BackgroundOne of the most frequent reasons for gynecologic imaging is adnexal masses. The aim of the study is to assess the diagnostic performance of ultrasonography in the identification of ambiguous adnexal masses using the O-RADS US scoring system.MethodsThis study included 108 cases and involved females with indeterminate adnexal masses, with any age group who were sent to the diagnostic ultrasonography department for evaluation of a worrisome adnexal mass lesion. We excluded patients who refused the examination despite informed discussion with the sonographer and patients with a previous history of operated adnexal lesion.ResultsBased on the O-RADS US score, more than half masses (52.8%) were diagnosed as O-RADS 3, which is low-risk malignant, and 47.2% were diagnosed as O-RADS 4, being intermediate-risk malignant. Regarding US O-RADS categorization in relation to the reference results by pathology, 57 lesions were categorized as O-RADS 3 by the US, and 18 of them was diagnosed as malignant according to pathology. Out of 51 lesions categorized as O-RADS 4 by the US, 30 were diagnosed as benign by pathology. At cutoff 4, the O-RADS US score for malignancy gave a sensitivity of 93.13% (95% CI 25.13–80.78), specificity of 66.72% (95% CI 34.49–76.81), PPV of 93.18% (95% CI 26.07–58.16), and NPV of 75.42% (95% CI 52.13–81.17) with an overall accuracy of 92.56% (95% CI 38.10–72.06).ConclusionsIn order to distinguish between benign and malignant neoplastic lesions, the US O-RADS classification system is a crucial non-invasive diagnostic tool for suspected ovarian tumors.

Diagnostic Performances of Ultrasound Evaluation of Major Salivary Glands According to the 2019 Outcome Measures in Rheumatology Ultrasound Scoring System.

To evaluate the diagnostic performance of ultrasound examination of the salivary glands (US-SG) according to the 2019 Outcome Measures in Rheumatology (OMERACT) US scoring system for Sjögren's syndrome (SS). The present work was a retrospective study based on a multicentric cohort with SS/sicca syndrome. The American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2016 classification criteria for SS (a score of ≥4 without ocular staining score), the American-European Consensus Group (AECG) 2002 classification criteria, and clinician experts were considered as reference standards for diagnosis of SS. An OMERACT score of ≥2 according to 2 independent readers defined the diagnosis of SS based on US-SG assessment. Diagnostic performances and interobserver reproducibility of US-SG were assessed. Forty-two patients fulfilling the ACR/EULAR 2016 criteria for SS were compared to 30 control subjects with sicca syndrome. Twenty-five patients were diagnosed as having SS according to US-SG evaluation, and they were more frequently observed in the SS group (52.5%) than in the control group (10.0%) (P < 0.001). US-SG showed an area under the curve (AUC) of 0.751 (95% confidence interval [95% CI] 0.621, 0.882) for the diagnosis of SS (ACR/EULAR 2016 classification). The inclusion of US-SG in the ACR/EULAR 2016 classification improved sensitivity (91.5% versus 89.4%) with limited decrease of specificity (96.0% versus 100%) and with an AUC of 0.975 (95% CI 0.945, 1.00). Similar results were observed when US-SG was included in the AECG 2002 classification criteria. Interobserver reproducibility of a score of ≥2 according to the 2019 OMERACT US scoring system for SS diagnosis was good (κ=0.73 [95% CI 0.64, 0.81]). Histologic lymphocyte infiltration of the minor salivary glands was associated with the OMERACT grading of US-SG. The present study confirms the good specificity of the 2019 OMERACT US classification measures of US-SG for the diagnosis of SS and its feasibility in daily practice.

Uniportal thoracoscopic decortication: start away from empyema approach

Aim: Video-assisted thoracoscopic surgery (VATS) is now a gold standard in treating early-stage empyema, while much debate still exists considering the effectiveness of this approach for late-stage empyema. Most concerns arise from the crowded rib cage, narrow working space, and ability to free trapped lungs quickly, mainly if uniportal VATS is used. However, unlike uniportal VATS lobectomy, there is no consensus about standard steps for uniportal VATS decortication to ensure smooth and effective surgery. We try to offer standard, easy-to-replicate steps for this approach to evaluate the efficacy and safety of the “start away from empyema” approach for uniportal VATS decortication in the management of stage II and III empyema. Methods: A prospective case series study has been conducted on 25 patients. All patients with stage II and III empyema were admitted to the Cardiothoracic Surgery Department between October 2017 and March 2020. VATS procedure was done under general anesthesia by a double-lumen tube for selective ventilation. Demographic data, preoperative diagnosis, intraoperative findings, hospital stay, and complications were recorded. Results: Twenty-five patients were enrolled in this study with a median age of 35 years. The duration of illness ranged between 14 and 60 days, with a median (IQR) of 25 (17) days. In (88%) of the patients, there was a successful outcome defined as a near-complete resolution on Chest X-ray (scoring of 3 or 4) and chest US (scoring of 2 or 3). Only three (12%) patients had a partially successful outcome. All patients with partial success suffered from infection associated with malignant effusion. Conclusion: “Start away from empyema” approach for uniportal VATS decortication in stage II and III empyema could be safe and effective in treating loculated nonmalignant pleural effusion.

Statistical Confirmation of a Method of US Determination of Bone Age

Background There is limited literature on conventional US to assess bone age. Purpose To determine the diagnostic performance of US in the assessment of abnormal bone age in Chinese children. Materials and Methods In this prospective study, children and young adults aged between birth and 19 years from a large provincial teaching hospital were enrolled from January to November 2020. Children without clinical diseases potentially affecting skeletal growth were included in the normal-value group. Children with clinically suspected growth disturbances who were undergoing bone age evaluation were included in the validation group. Ossification ratios (ie, the ratio of the height of the epiphyseal ossification center to the entire epiphysis, including the cartilaginous component) of the radius, ulna, and femur from all the children were measured using US. Ultrasonic skeletal maturity scores (ie, the summation of ossification ratios of the radius, ulna, and femur multiplied by 100) collected from children in the normal-value group were used for score-for-age curve fitting through Box-Cox power exponential distribution. Test performance characteristics for the ability of US to help diagnose abnormal bone age were determined using radiographic bone age as a reference standard. Statistically significant difference between groups was determined by using a paired-sample t test. Results A total of 1089 children (median age, 9 years [interquartile range, 3-14 years]; 578 boys) were enrolled, including 929 children (mean age, 8 years [interquartile range, 4-12 years]; 515 boys) in the normal-value group and 160 children (mean age, 9 years [interquartile range, 7-11 years]; 63 boys) in the validation group. Ultrasonic bone ages in the validation group were evaluated with use of the lists of normal score-for-age values. With radiographic bone age as a reference standard, US could help diagnose abnormal bone age with high sensitivity (93% [14 of 15 participants; 95% CI: 66, 100] for boys, 100% [14 of 14 participants; 95% CI: 73, 100] for girls) and specificity (98% [47 of 48 participants; 95% CI: 88, 100] for boys, 98% [81 of 83 participants; 95% CI: 91, 100] for girls). Conclusion The US scoring system established can be used to evaluate bone age with high sensitivity and specificity. Clinical trial registration no. ChiCTR1900027917 © RSNA, 2021 Online supplemental material is available for this article.

Non-invasive staging of liver fibrosis by two-dimensional shear wave elastography (2D-SWE) in patients with chronic hepatitis C and B

BackgroundNon-invasive shear wave-based techniques have been developed for estimating liver fibrosis in patients with chronic liver diseases. Two-dimensional shear wave elastography provides in real-time, a tow dimensional quantitative map of tissue stiffness and enables measuring the stiffness by adjustment of a region of interest of tissue. The aim of this study was to highlight the role of tow dimensional shear wave elastography (2D-SWE) in detecting the degree of liver fibrosis in patients with chronic hepatitis C and B, in correlation with liver enzymes level and fibrotest.ResultsThis study included 50 patients with chronic hepatitis C and B whose ages were (range, 30-65 years; mean, 48 years). Shear wave elastography cutoff values were 1.35 m/s, 5.48 KPa for (F>0); 1.66 m/s, 8.29 kPa for (F>1); 1.77 m/s, 9.40 kPa for (F>2); and 1.99 m/s, 11.9 kPa for (F>3). An excellent agreement was found between shear wave elastography and Fibrotest in staging of liver fibrosis in 88% of patients (κw=0.943, 95% CI, 0.88 to 1.00) achieving a highly statistical significance (P<0.001). There was a significant moderate positive concordance between US scoring and staging by 2D-SWE and staging by Fibrotest (rs, 0.49; P<0.01) and (rs, 0.48; P<0.01) respectively. However, no significant concordances were noticed between staging by AST and ALT and 2D-SWE and staging by Fibrotest (P>0.05).Conclusions2D shear wave elastography showed better diagnostic performance than visual assessment by conventional US for detection of chronic liver diseases, as well as for evaluation of their severity and prognosis. Elastograhy—Fibrotest combination gives best diagnostic performance in detecting the degree of fibrosis non-invasively and can be used reliably as a first-line pre-therapeutic evaluation of fibrosis in HCV and HBV-infected patients.

Patient-based reliability of the Outcome Measures in Rheumatology (OMERACT) ultrasound scoring system for salivary gland assessment in patients with Sjögren’s syndrome

Abstract Background To assess the reliability of the consensually agreed US definitions of major salivary gland lesions and the US scoring system for salivary gland assessment in patients with SS. Methods Nine experienced sonographers scanned and read the US images of both parotid glands (PGs) and submandibular glands (SMGs) in eight patients with primary and secondary SS in two rounds. A consensually agreed four-grade semi-quantitative scoring was applied in B-mode for morphological lesions: grade 0, normal; grade 1, mild inhomogeneity without anechoic or hypoechoic areas; grade 2, moderate inhomogeneity with focal anechoic or hypoechoic areas; grade 3, severe inhomogeneity with diffuse an- or hypoechoic areas occupying the entire gland or fibrous gland. The presence or absence of typical SS lesions, i.e. the Sjögren’s signature, was scored binary. Intra- and interreader reliabilities were computed using weighted and unweighted Cohen’s and Light’s κ coefficients. Results The mean prevalence of grades 0–3 in PG were 43, 17, 23 and 31% and 28, 14, 33 and 32% for the SMGs, respectively. The weighted κ for intrareader reliability ranged from 0.44 to 1 for grading and 0.64 to 1 for the Sjögren’s signature of PG and 0.59 to 1 and −0.09 to 0.6 for SMGs, respectively. The interreader reliability κ for grading in PG was 0.62 (95% CI 0.47, 0.74) and for Sjögren’s signature it was 0.36 (95% CI 0, 0.43); in SMG it was 0.62 (95% CI 0.47, 0.72) and 0.03 (95% CI 0, 0.07) respectively. Conclusions The consensually agreed novel US scoring system for major salivary gland lesions showed substantial intra- and interreader reliability in patients with SS. The reliability of the Sjögren’s signature was moderate.

Differential diagnosis between hepatic alveolar echinococcosis and intrahepatic cholangiocarcinoma with conventional ultrasound and contrast-enhanced ultrasound

BackgroundMisclassifications of hepatic alveolar echinococcosis (HAE) as intrahepatic cholangiocarcinoma (ICC) may lead to inappropriate treatment strategies. The aim of this study was to explore the differential diagnosis with conventional ultrasound and contrast-enhanced ultrasound (CEUS).MethodsSixty HAE lesions with 60 propensity score-matched ICC lesions were retrospectively collected. The 120 lesions were randomly divided into a training set (n = 80) and a testing set (n = 40). In the training set, the most useful independent conventional ultrasound and CEUS features was selected for differentiating between HAE and ICC. Then, a simplified US scoring system for diagnosing HAE was constructed based on selected features with weighted coefficients. The constructed US score for HAE was validated in both the training set and the testing set, and diagnostic performance was evaluated.ResultsCompared with ICC lesions, HAE lesions were mostly located in the right lobe and had mixed echogenicity, a pseudocystic appearance and foci calcifications on conventional ultrasound. On CEUS, HAE lesions showed more regular rim-like enhancement than ICC lesions and had late washout with a long enhancement duration. The simplified US score consisted of echogenicity, pseudocystic/calcification, bile duct dilatation, enhancement pattern, enhancement duration, and marked washout. In the testing set, the sensitivity, specificity, LR+, LR- and the area under the ROC curve for the score to differentiate HAE from ICC were 80.0, 81.3%, 4.27, 0.25 and 0.905, respectively.ConclusionsThe US score based on typical features from both conventional ultrasound and CEUS could accurately differentiate HAE from ICC.

Development of semiquantitative ultrasound scoring system to assess cartilage in rheumatoid arthritis.

To develop and test the reliability of a new semiquantitative scoring system for the assessment of cartilage changes by ultrasound in a web-based exercise as well as a patient exercise of patients with RA. A taskforce of the Outcome Measures in Rheumatology Ultrasound Working Group performed a systematic literature review on the US assessment of cartilage in RA, followed by a Delphi survey on cartilage changes and a new semiquantitative US scoring system, and finally a web-based exercise as well as a patient exercise. For the web-based exercise, taskforce members scored a dataset of anonymized static images of MCP joints in RA patients and healthy controls, which also contained duplicate images. Subsequently, 12 taskforce members used the same US to score cartilage in MCP and proximal interphalangeal joints of six patients with RA in in a patient reliability exercise. Percentage agreement and prevalence of lesions were calculated, as intrareader reliability was assessed by weighted kappa and interreader reliability by Light's kappa. The three-grade semiquantitative scoring system demonstrated excellent intrareader reliability (kappa: 0.87 and 0.83) in the web-based exercise and the patient exercise, respectively. Interreader reliability was good in the web-based exercise (kappa: 0.64) and moderate (kappa: 0.48) in the patient exercise. Our study demonstrates that ultrasound is a reliable tool for evaluating cartilage changes in the MCP joints of patients with RA and supports further development of a new reliable semiquantitative ultrasound scoring system for evaluating cartilage involvement in RA.

Intravenous Contrast-Enhanced Ultrasound for Assessing and Grading Postoperative Recurrence of Crohn's Disease.

The aim was to investigate the contribution of contrast-enhanced ultrasound (CEUS) to improve the results of US in the evaluation of recurrence in postsurgical Crohn's disease (CD) and establish its role in the assessment of the severity. Anastomotic site was assessed in 108 postsurgical CD patients with B-mode, color Doppler and CEUS. Bowel wall thickness (WT), transmural complications or stenosis, color Doppler grade, and bowel wall contrast enhancement (BWCE)-using time-intensity curves-were correlated with endoscopic Rutgeerts score. A receiver operating characteristic (ROC) curve was built to establish the best cutoff to predict recurrence and the severity. A US scoring system was elaborated in order to determine the grade of recurrence. Ileocolonoscopy detected recurrence in 90 (83.3%) subjects and severe recurrence in 62. WT ≥ 3mm had an accuracy of 90.7% in the detection of endoscopic recurrence. The combination of parameters-WT ≥ 3mm and BWCE (≥ 46%)-demonstrated similar accuracy (90.7%). A WT ≥ 5mm showed the best specificity (100%) for the diagnosis of recurrence and a WT ≥ 6mm the best specificity (95.7%) for the detection of severe recurrence. The combination of sonographic parameters-WT ≥ 6mm or WT between 5 and 6mm with BWCE ≥ 70%, or complications-obtained the best results grading the recurrence (sensitivity, specificity, and accuracy of 90.3%, 87%, and 88.9%, respectively). US shows high sensitivity and specificity for the diagnosis of postsurgical recurrence. When combined with CEUS, it can improve the detection of severe recurrence.

Consequences of false-positive screening mammograms.

False-positive mammograms, a common occurrence in breast cancer screening programs, represent a potential screening harm that is currently being evaluated by the US Preventive Services Task Force. To measure the effect of false-positive mammograms on quality of life by measuring personal anxiety, health utility, and attitudes toward future screening. The Digital Mammographic Imaging Screening Trial (DMIST) quality-of-life substudy telephone survey was performed shortly after screening and 1 year later at 22 DMIST sites and included randomly selected DMIST participants with positive and negative mammograms. Mammogram requiring follow-up testing or referral without a cancer diagnosis. The 6-question short form of the Spielberger State-Trait Anxiety Inventory state scale (STAI-6) and the EuroQol EQ-5D instrument with US scoring. Attitudes toward future screening as measured by women's self-report of future intention to undergo mammographic screening and willingness to travel and stay overnight to undergo a hypothetical new type of mammography that would identify as many cancers with half the false-positive results. Among 1450 eligible women invited to participate, 1226 (84.6%) were enrolled, with follow-up interviews obtained in 1028 (83.8%). Anxiety was significantly higher for women with false-positive mammograms (STAI-6, 35.2 vs 32.7), but health utility scores did not differ and there were no significant differences between groups at 1 year. Future screening intentions differed by group (25.7% vs 14.2% more likely in false-positive vs negative groups); willingness to travel and stay overnight did not (9.9% vs 10.5% in false-positive vs negative groups). Future screening intention was significantly increased among women with false-positive mammograms (odds ratio, 2.12; 95% CI, 1.54-2.93), younger age (2.78; 1.5-5.0), and poorer health (1.63; 1.09-2.43). Women's anticipated high-level anxiety regarding future false-positive mammograms was associated with willingness to travel overnight (odds ratio, 1.94; 95% CI, 1.28-2.95). False-positive mammograms were associated with increased short-term anxiety but not long-term anxiety, and there was no measurable health utility decrement. False-positive mammograms increased women's intention to undergo future breast cancer screening and did not increase their stated willingness to travel to avoid a false-positive result. Our finding of time-limited harm after false-positive screening mammograms is relevant for clinicians who counsel women on mammographic screening and for screening guideline development groups.

SAT0509 Three-Dimensional Versus Two-Dimensional Ultrasonography in the Assessment of Peripheral Enthesitis in Spondylarthritis

BackgroundPower Doppler ultrasonography (PdUS) is widely used for the evaluation of the entheses in spondylarthritis (SpA). PdUS has been shown to be useful for the diagnosis and the evaluation of...

OP0170 The Radiocarpal and MCP2 Joints Should be Included in Ultrasonographic Follow-Up of RA Patients During Biologic Treatment

BackgroundUltrasound (US) (grey scale (GS) and power Doppler (PD)) is sensitive for scoring of synovitis in patients with rheumatoid arthritis (RA), with excellent reliability for semi-quantitative scoring (0-3) of GS...

SAT0511 Achieving Consensus in Ultrasonography Synovitis Scoring in Rheumatoid Arthritis

BackgroundUltrasonography (US) is a sensitive method for synovitis detection in clinical practice but interobserver variation in both acquisition and image intepretation is still a key concern [1]. Various semiquantitative synovitis...

The Cost Effectiveness of Surgical Versus Nonoperative Treatment for Lumbar Disc Herniation Over Two Years

Spine Patient Outcomes Research Trial observational and randomized cohort participants with a confirmed diagnosis of intervertebral disc herniation (IDH) who received either usual nonoperative care and/or standard open discectomy were followed from baseline at 6 weeks, 3, 6, 12, and 24 months at 13 spine clinics in 11 US states. To evaluate the cost-effectiveness of surgery relative to nonoperative care among patients with a confirmed diagnosis of lumbar IDH. The cost-effectiveness of surgery as a treatment for conditions associated with low back and leg symptoms remains poorly understood. Incremental cost-effectiveness ratio, reported as discounted cost per quality adjusted life year (QALY) gained in 2004 US dollars based on EuroQol EQ-5D health state values with US scoring, and information on resource utilization and time away from work. Among 775 patients who underwent surgery and 416 who were treated nonoperatively, the mean difference in QALYs over 2 years was 0.21 (95% CI: 0.16-0.25) in favor of surgery. Surgery was more costly than nonoperative care; the mean difference in total cost was $14,137(95% CI: $11,737-16,770). The cost per QALY gained for surgery relative to nonoperative care was $69,403 (95% CI: $49,523-94,999) using general adult surgery costs and $34,355 (95% CI: $20,419-52,512) using Medicare population surgery costs. Surgery for IDH was moderately cost-effective when evaluated over 2 years. The estimated economic value of surgery varied considerably according to the method used for assigning surgical costs.

Race and Ethnic Disparities in Valuing Health

Patient preferences are often cited as a possible explanation for disparities in treatment. However, no prior studies have examined whether there are racial and ethnic differences in preferences for health states in a general population sample. Data from 21,362 adult respondents to the 2002 Medical Expenditure Panel Survey were used to study variations in valuations of health states. Respondents' health states were valued based on the self-rated Visual Analogue Scale (VAS) and the Euro-Qol-5D using the US and UK societal scoring algorithms. Regression analyses determined whether valuations in health states varied by race or Hispanic origin, controlling for socioeconomic status and place of residence. Race and ethnicity were not associated with differences in valuations of health states. However, there were systematic differences in characteristics that were controlled, such as health status, age, poverty status, and region of the country. Blacks and Hispanics had slightly higher VAS scores than whites. The negative influence of pain/ discomfort on the VAS score was greater for blacks and Hispanics. Racial and ethnic differences in treatment preferences probably do not result from differences in health state valuations. Future research should explore whether differences in preferences for other attributes of treatment account for differences in treatment decisions. Cost-utility researchers using the EuroQol-5D or VAS need not account for blacks' and Hispanics' systematically valuing health states differently than whites do. However, caution may be warranted when considering interventions designed to manage pain or discomfort, because blacks and Hispanics gave greater weight to that domain of health status in their valuations.

The Significance of Using US-Valued EQ-5D Health States for Comparative Effectiveness and Cost-Effectiveness Studies in US Populations

Two articles published in this issue, ‘‘A Comparison of EQ-5D Index Scores Derived from the US and UK Population-Based Scoring Functions’’ by Nan Luo and colleagues and ‘‘The Implications of Using US-Specific EQ-5D Preference Weights for Cost-Effectiveness Evaluation’’ by Katia Noyes and colleagues, substantially advance our understanding of the relative performance of USand UK-based EQ-5D preference scores. The study by Luo and others extends the previous work of its authors, who conducted the 2002 US valuation survey for the EQ-5D, using methods largely consistent with those of the 1993 UK valuation survey. Their new study compares the full complement of 243 EQ-5D health state scores predicted by the statistical models developed from the US and UK valuation surveys (both of which directly valued the same 42 common EQ-5D health states). Not surprisingly, like the authors’ earlier comparison of the directly valued health states, the US statistical model consistently predicted health state scores that were higher than those predicted by the UK model. Over the full set of EQ-5D health states, the difference in mean scores was 0.23, as compared with the 0.11 difference found for the smaller number of directly valued states in the earlier comparison. More notably, the new study found a mean difference in transitions between all pairs of health states of 0.25 for the US valuation model and 0.35 for the UK model: The range of all EQ-5D health state valuations in the US model was more compressed than in the UK model. The authors reasonably surmise that although incremental cost-effectiveness ratios (ICERs) calculated using the US model values would likely be less favorable than those using the UK model values, this result would depend on the nature of the condition under study, the severity of the health states, and the size of the health effect. Noyes and colleagues take another step and examine the differences in results between the USand UK-valued EQ-5D statistical models in a costeffectiveness analysis. Using the US values, they reanalyze data from a clinical trial comparing 2 alternative drug therapies (initial pramipexole v. levodopa) in patients with Parkinson disease, which originally used health state values from the UK EQ5D model (see references 15-17 in the article by Noyes and others). The comparative performance of the USand UK-valued EQ-5D models was consistent with the simulated results that Luo and others obtained: Measured over time, the USand UKspecific EQ-5D scores for patients with Parkinson disease followed similar trajectories, except that the US scores were higher on average. As in the simulation exercise, the range of scores using the US values was more compressed than that with the UK values. In particular, Noyes and others found greater differences between the US and UK estimates among subjects who reported problems with usual activities, pain/discomfort, or anxiety/depression than between the estimates for subjects not reporting these problems. As the authors conclude, the implications of the more compressed range of scores using the US valuation model are that the estimated 4-year gains in quality-adjusted life years (QALYs) of the experimental over the control therapy are less than half as large as those using the UK model, a much less favorable ICER ($108,000/QALY v. $43,000/QALY) and a lower probability that the experimental therapy is cost-effective at any dollar-per-QALY threshold. Taken together, these 2 studies offer insight into how valuations of health states based on the USand UK-valued EQ-5D statistical models compare From the Department of Health Policy, George Washington University School of Public Health and Health Services, Washington, DC.

A Comparison of EQ-5D Index Scores Derived from the US and UK Population-Based Scoring Functions

The authors recently introduced a new preference-based scoring function for the EQ-5D (D1 model) based on time tradeoff valuations from the general adult US population: In this study, they compared the EQ-5D index scores derived from the US (D1) algorithm to the more familiar UK (N3) algorithm. They compared preference-based EQ-5D index scores for all possible EQ-5D health states and differences in EQ-5D index scores between pairs of EQ-5D health states predicted by the D1 and N3 models. The responsiveness of D1- and N3-predicted EQ-5D index scores was assessed using simulated transitions between EQ-5D health states. The mean (SD) EQ-5D index scores for all 243 health states predicted by the D1 and N3 models were 0.37 (0.23) and 0.14 (0.31), respectively. The mean (SD) absolute difference in EQ-5D index scores for all 29,403 pairs of health states was 0.25 (0.19) and 0.35 (0.27), according to the D1 and N3 models, respectively. The D1 and N3 models were consistent in predicting gains/losses for 27,592 (94%) transitions between EQ-5D health state pairs; Cohen effect size, calculated using these 27,592 consistent transitions, was 1.58 and 1.59 for the D1 and N3 models, respectively. Based on these simulation results, it appears that the D1 model would lead to smaller gains in quality-adjusted life years than the N3 model; however, their responsiveness appears to be similar. Empirical studies are needed to examine whether these 2 EQ-5D scoring functions would lead to different conclusions in cost-utility analyses.

Assessing responsiveness of generic and specific health related quality of life measures in heart failure

BackgroundResponsiveness, or sensitivity to clinical change, is an important consideration in selection of a health-related quality of life (HRQL) measure for trials or clinical applications. Many approaches can be used to assess responsiveness, which may affect the interpretation of study results. We compared the relative responsiveness of generic and heart failure specific HRQL instruments, as measured both by common psychometric indices and by external clinical criteria.MethodsWe analyzed data collected at baseline and 6-weeks in 298 subjects with heart failure on the following HRQL measures: EQ-5D (US, UK, and VAS Scoring), Kansas City Cardiomyopathy Questionnaire (KCCQ) (Clinical and Overall Summary Score), and RAND12 (Physical and Mental Component Summaries). Three external indicators of clinical change were used to classify subjects as improved, deteriorated, or unchanged: 6-minute walk test, New York Heart Association (NYHA) class, and physician global rating of change. Four responsiveness statistics (T-test, effect size, Guyatt's responsiveness statistic, and standardized response mean) were used to evaluate the responsiveness of the select measures. The median rank of each HRQL measure across responsiveness indices and clinical criteria was then determined.ResultsAverage age of subjects was 60 years, 75 percent were male, and had moderate to severe heart failure symptoms. Overall, the KCCQ Summary Scores had the highest relative ranking, irrespective of the responsiveness index or external criterion used. Importantly, we observed that the relative ranking of responsiveness of the generic measures (i.e. EQ-5D, RAND12) was influenced by both the responsive indices and external criterion used.ConclusionThe disease specific KCCQ was the most responsive HRQL measure assessing change over a 6-week period, although generic measures provide information for which the KCCQ is not suitable. The responsiveness of generic HRQL measures may be affected by the index used, as well as the external criterion to classify patients who have clinically change or remained stable.