Clinical presentation of women with pelvic source varicose veins in the perineum as a first step in the development of a disease-specific patient assessment tool.

OBJECTIVE: Pelvic venous incompetence can cause symptomatic varicose veins in the perineum, buttock, and thigh. Presentation, symptom severity, and response to treatment of pelvic source varicose veins are not well defined. Currently available tools to measure the severity of lower extremity venous disease and its effects on quality of life may be inadequate to assess disease severity in these patients. The purpose of this study was to evaluate the histories, demographics, and clinical presentations of women with pelvic source varicose veins and to compare these data to a population of women with nonpelvic source varicose veins. METHODS: A total of 72 female patients with symptomatic pelvic source varicose veins were prospectively followed up. Age, weight, height, parity, and birth weights of offspring were recorded. Both pelvic source varicose veins and saphenous incompetence were identified by duplex ultrasound. Patients were queried as to their primary symptoms, activities that made their symptoms worse, and time when their symptoms were most prominent. Severity of disease was objectively evaluated using the revised Venous Clinical Severity Score (rVCSS) and 10-point numeric pain rating scale (NPRS). RESULTS: Compared with women without a pelvic source of varicose veins (N = 1163), patients with pelvic source varicose veins were younger (mean, 44.6 ± 8.6 vs 52.6 ± 12.9 years; P < .001), had lower body mass index (mean, 21.9 ± 2.8 vs 25.8 ± 6.2; P < .001), and had larger babies than the U.S. population mean (mean, 3656 ± 450 g vs 3389 ± 466 g; P < .001). The most common symptoms were aching (68%), throbbing (47%), and heaviness (35%). In premenopausal patients, 70% noted that symptoms were worst during menses. NPRS score varied from 0 to 8 (mean, 4.9). The correlation between rVCSS (mean 5.6 ± 1.9) and NPRS was small (r = 0.26; P = .03). There was a modest correlation between older age and lower NPRS scores (r = -0.39; P < .001). CONCLUSIONS: Women with pelvic source varicose veins are a unique subset of patients. They are younger and thinner than those with nonpelvic source varicose veins, have larger infants than the general U.S. population, and have an inverse correlation between age and pain. As the majority of premenopausal patients have increased symptoms during menses, this may be due to hormonal influence. As it is poorly associated with patient-reported discomfort, the rVCSS is a poor tool for evaluating pelvic source varicose veins. A disease-specific tool for the evaluation of pelvic source varicose veins is critically needed, and this study is a first step in that endeavor.

Scan-rescan reproducibility of quantitative assessment of inflammatory carotid atherosclerotic plaque using dynamic contrast-enhanced 3T CMR in a multi-center study.

BACKGROUND: The aim of this study is to investigate the inter-scan reproducibility of kinetic parameters in atherosclerotic plaque using dynamic contrast-enhanced (DCE) cardiovascular magnetic resonance (CMR) in a multi-center setting at 3T. METHODS: Carotid arteries of 51 subjects from 15 sites were scanned twice within two weeks on 3T scanners using a previously described DCE-CMR protocol. Imaging data with protocol compliance and sufficient image quality were analyzed to generate kinetic parameters of vessel wall, expressed as transfer constant (K trans ) and plasma volume (v p ). The inter-scan reproducibility was evaluated using intra-class correlation coefficient (ICC) and coefficient of variation (CV). Power analysis was carried out to provide sample size estimations for future prospective study. RESULTS: Ten (19.6%) subjects were found to suffer from protocol violation, and another 6 (11.8%) had poor image quality (n=6) in at least one scan. In the 35 (68.6%) subjects with complete data, the ICCs of K trans and v p were 0.65 and 0.28, respectively. The CVs were 25% and 62%, respectively. The ICC and CV for v p improved to 0.73 and 28% in larger lesions with analyzed area larger than 25 mm2. Power analysis based on the measured CV showed that 50 subjects per arm are sufficient to detect a 20% difference in change of K trans over time between treatment arms with 80% power without consideration of the dropout rate. CONCLUSION: The result of this study indicates that quantitative measurement from DCE-CMR is feasible to detect changes with a relatively modest sample size in a prospective multi-center study despite the limitations. The relative high dropout rate suggested the critical needs for intensive operator training, optimized imaging protocol, and strict quality control in future studies.

Determination of colonoscopy indication from administrative claims data.

BACKGROUND: Colonoscopy outcomes, such as polyp detection or complication rates, may differ by procedure indication. OBJECTIVES: To develop methods to classify colonoscopy indications from administrative data, facilitating study of colonoscopy quality and outcomes. RESEARCH DESIGN: We linked 14,844 colonoscopy reports from the Clinical Outcomes Research Initiative, a national repository of endoscopic reports, to the corresponding Medicare Carrier and Outpatient File claims. Colonoscopy indication was determined from the procedure reports. We developed algorithms using classification and regression trees and linear discriminant analysis (LDA) to classify colonoscopy indication. Predictor variables included ICD-9CM and CPT/HCPCS codes present on the colonoscopy claim or in the 12 months prior, patient demographics, and site of colonoscopy service. Algorithms were developed on a training set of 7515 procedures, then validated using a test set of 7329 procedures. RESULTS: Sensitivity was lowest for identifying average-risk screening colonoscopies, varying between 55% and 86% for the different algorithms, but specificity for this indication was consistently over 95%. Sensitivity for diagnostic colonoscopy varied between 77% and 89%, with specificity between 55% and 87%. Algorithms with classification and regression trees with 7 variables or LDA with 10 variables had similar overall accuracy, and generally lower accuracy than the algorithm using LDA with 30 variables. CONCLUSIONS: Algorithms using Medicare claims data have moderate sensitivity and specificity for colonoscopy indication, and will be useful for studying colonoscopy quality in this population. Further validation may be needed before use in alternative populations.

Demographics of disclosure of conflicts of interest at the 2011 annual meeting of the American Academy of Orthopaedic Surgeons.

BACKGROUND: There is growing concern regarding conflicts of interest in orthopaedic research and education. Because of their potential influence on orthopaedic practice, conflicts of interest among participants in the educational programs of the American Academy of Orthopaedic Surgeons (AAOS) are of particular interest. METHODS: We analyzed the voluntarily disclosed conflicts of interest listed in the Final Program of the 2011 Annual Meeting of the AAOS for the relevant program committees as well as for presentations in the disciplines of pediatric orthopaedic surgery, spine, and sports medicine/arthroscopy. RESULTS: Conflicts of interest were disclosed by participants for each of the program committees and for over 75% of the presentations. Conflicts of interest were disclosed for 100% of the featured symposia, 80% of the scientific exhibits, 76% of the podium presentations, and 75% of the posters. Over half (53%) of the disclosures were for paid consultancy, 51% were for research support for the principal investigator, 41% were for paid presentations, 39% were for royalties, and 39% were for stock. The highest number of disclosures for an individual author was thirty-seven. The number of disclosures per author was significantly (p < 0.001) correlated to the number of presentations per author. Disclosures were associated with 379 different companies; relationships with a relatively small number (twenty-six, 7%) of these companies were listed in the disclosures for 67% of the presentations. CONCLUSIONS: Voluntarily disclosed conflicts of interest were common at the 2011 AAOS Annual Meeting, especially for the featured symposia. In view of the previously documented frequency of undisclosed conflicts of interest, as well as the previously documented effects of conflicts of interest on research design, conduct, and conclusion, it may be time to consider improved strategies for ensuring the accuracy and completeness of disclosure and for managing the biasing effects of conflicts of interest.

MR imaging of carotid plaque composition during lipid-lowering therapy a prospective assessment of effect and time course.

OBJECTIVES: The purpose of this study was to test the lipid depletion hypothesis and to establish the time course of change in carotid plaque morphology and composition during lipid therapy using high-resolution magnetic resonance imaging (MRI). BACKGROUND: Lipid therapy is thought to improve plaque stability and reduce cardiovascular events by targeting the plaque rupture risk features such as large lipid core, thin fibrous cap, and high level of inflammatory infiltrates. However, the plaque stabilizing process during lipid therapy has not been clearly demonstrated in humans and in vivo. METHODS: Subjects with coronary or carotid artery disease, apolipoprotein B ≥120 mg/dl, and lipid treatment history <1 year, were randomly assigned to atorvastatin monotherapy or to atorvastatin-based combination therapies with appropriate placebos for 3 years. All subjects underwent high-resolution, multicontrast bilateral carotid MRI scans at baseline and annually for 3 years. All images were analyzed for quantification of wall area and plaque composition blinded to therapy, laboratory results, and clinical course. RESULTS: After 3 years of lipid therapy, the 33 subjects with measurable lipid-rich necrotic core (LRNC) at baseline had a significant reduction in plaque lipid content: LRNC volume decreased from 60.4 ± 59.5 mm(3) to 37.4 ± 69.5 mm(3) (p < 0.001) and %LRNC (LRNC area/wall area in the lipid-rich regions) from 14.2 ± 7.0% to 7.4 ± 8.2% (p < 0.001). The time course showed that %LRNC decreased by 3.2 (p < 0.001) in the first year, by 3.0 (p = 0.005) in the second year, and by 0.91 (p = 0.2) in the third year. Changes in LRNC volume followed the same pattern. Percent wall volume (100 × wall/outer wall, a ratio of volumes) in the lipid-rich regions significantly decreased from 52.3 ± 8.5% to 48.6 ± 9.7% (p = 0.002). Slices containing LRNC had significantly more percent wall volume reduction than those without (-4.7% vs. -1.4%, p = 0.02). CONCLUSIONS: Intensive lipid therapy significantly depletes carotid plaque lipid. Statistically significant plaque lipid depletion is observed after 1 year of treatment and continues in the second year, and precedes plaque regression. (Using Magnetic Resonance Imaging to Evaluate Carotid Artery Plaque Composition in People Receiving Cholesterol-Lowering Medications [The CPC Study]; NCT00715273).

Comparing the psychometric properties of the Checklist of Nonverbal Pain Behaviors (CNPI) and the Pain Assessment in Advanced Dementia (PAIN-AD) instruments.

OBJECTIVE: To examine and compare the psychometric properties of two common observational pain assessment tools used in persons with dementia. DESIGN: In a cross-sectional descriptive study nursing home (NH) residents were videotaped at rest and during a structured movement procedure. Following one training session and one practice session, two trained graduate nursing research assistants independently scored the tapes using the two pain observation tools. SETTING: Fourteen NHs in Western Washington State participating in a randomized controlled trial of an intervention to enhance pain assessment and management. PARTICIPANTS: Sixty participants with moderate to severe pain were identified by nursing staff or chosen based on the pain items from the most recent Minimum Data Set assessment. MEASURES: Checklist of Nonverbal Pain Indicators (CNPI) and the Pain Assessment in Advanced Dementia (PAINAD), demographic and pain-related data (Minimum Data Set), nursing assistant reports of participants' usual pain intensity, and Pittsburgh Agitation Scale. RESULTS: Internal consistency for both tools was good except for the CNPI at rest for one rater. Inter-rater reliability for pain presence was fair (K = 0.25 for CNPI with movement; K = 0.31 for PAINAD at rest) to moderate (K = 0.43 for CNPI at rest; K = 0.54 for PAINAD with movement). There were significant differences in mean CNPI and PAINAD scores at rest and during movement, providing support for construct validity. However, both tools demonstrated marked floor effects, particularly when participants were at rest. CONCLUSIONS: Despite earlier studies supporting the reliability and validity of the CNPI and the PAINAD, findings from the current study indicate that these measures warrant further study with clinical users, should be used cautiously both in research and clinical settings and only as part of a comprehensive approach to pain assessment.