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Objective

The goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer–related lymphedema, for use in the context of outcome evaluation in clinical trials.

Design

Blinded repeated measures observational study.

Setting

Outpatient research laboratory.

Participants

Breast cancer survivors with and without lymphedema (N=71).

Interventions

Not applicable.

Main Outcome Measure

The assessment of intraclass correlation coefficients (ICCs) for the Breast Cancer–Related Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool.

Results

Intrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95% CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95). Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema overall score.

Conclusions

The CLUE tool shows excellent inter- and intrarater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.  相似文献   
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《Vaccine》2015,33(22):2517-2520
BackgroundThe accuracy of vaccine administration information recorded in administrative claims databases is uncertain.MethodsWe conducted a retrospective cohort study using the HealthCore Integrated Research DatabaseSM among infants who received at least 1 RotaTeq® (RV5) dose during the first year of life between February 1, 2006 and November 30, 2012 and were enrolled in the health plan at birth. We reviewed medical records for a sample of infants to validate vaccine administration information.ResultsWe identified 169,560 infants who received at least 1 RV5 dose. Medical records were obtained for 85 infants, of which 74 (PPV1 87.1%; 95% CI 78.0–93.4%) had a corresponding first RV5 vaccination in the medical record with the same or similar administration date.ConclusionsAdministrative claims contained inaccuracies in dose number or administration date for 13% of RV5 first doses identified.  相似文献   
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《Vaccine》2015,33(3):479-486
We examined completion and compliance rates of rotavirus (RV) vaccination according to the recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Food and Drug Administration approved Prescribing Information (PI) for Rotarix® (RV1, GlaxoSmithKline Vaccines) and RotaTeq® (RV5, Merck and Co.) among infants under one year of age covered by Medicaid programs. Healthcare claims data from state Medicaid programs that constituted the Truven Health MarketScan® Multi-State Medicaid Database were retrieved from May 2008–June 2012. Infants were grouped under PI and ACIP cohorts based on the dosing regimens followed. The overall compliance per PI (n = 673,956) and ACIP (n = 695,612) recommendations were 24.5% and 28.2%, respectively; completion rates were 30.3% and 32.6%, respectively. In the PI cohort, infants who received RV1 had significantly higher compliance as compared with infants who received RV5 (65.2% vs. 31.3%; p < 0.0001); completion rates among infants receiving RV1 and RV5 were 65.3% and 46.4%, respectively (p < 0.0001). In the ACIP cohort, compliance with RV1 was significantly higher than RV5 (68.8% vs. 45.9%; p < 0.0001) as was the overall completion rate (73.5% vs. 48.8%; p < 0.0001). While compliance is increasing year over year, overall compliance of RV vaccines is suboptimal, with over 40% of eligible infants unvaccinated in both populations. The 2-dose RV vaccine showed better completion rates and higher compliance than the 3-dose RV vaccine in the United States. Public health initiatives focusing on suboptimal compliance and completion rates of RV vaccination in the Medicaid population could improve these metrics, thereby offering protection against RV infection.  相似文献   
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BackgroundCorticosteroids have a negative impact on the human immune system’s ability to function at an optimal level. Studies have shown that patients on long-term corticosteroids have higher infection rates. However, the rates of infection and other complications following lumbar decompression surgery remains under-investigated. The aim of our study was to determine the impact of preoperative long-term corticosteroid usage on acute, 30-day postoperative complications in a subset of patients undergoing lumbar spine decompression surgery, without fusion or instrumentation. We hypothesize that patients on long-term corticosteroids will have higher rates of infection and other postoperative complications after undergoing lumbar decompression surgery of the spine.MethodsA retrospective cohort study was conducted using data collected from the National Surgical Quality Improvement Program database data from 2005 to 2016. Lumbar decompression surgeries, including discectomies, laminectomies, and others were identified using CPT codes. Chi-square analysis was used to evaluate differences among the corticosteroid and non-corticosteroid groups for demographics, preoperative comorbidities, and postoperative complications. Logistic regression analysis was done to determine if long-term corticosteroid use predicts incidence of postoperative infections following adjustment.Results26,734 subjects met inclusion criteria. A total of 1044 patients (3.9%) were on long-term corticosteroids prior to surgical intervention, and 25,690 patients (96.1%) were not on long-term corticosteroids. Patients on long-term corticosteroids were more likely to be older (p < 0.001), female (p < 0.001), nonsmokers (p < 0.001), and have a higher American Society of Anesthesiologist class (p < 0.001). Multivariate analysis demonstrated that long-term corticosteroid usage was associated with increased overall complications (odds ratio [OR]: 1.543; p < 0.001), and an independent risk factor for the development of minor complications (OR: 1.808; p < 0.001), urinary tract infection (OR: 2.033; p = 0.002), extended length of stay (OR: 1.244; p = 0.039), thromboembolic complications (OR: 1.919; p = 0.023), and sepsis complications (OR: 2.032; p = 0.024).ConclusionLong-term corticosteroid usage is associated with a significant increased risk of acute postoperative complication development, including urinary tract infection, sepsis and septic shock, thromboembolic complications, and extended length of hospital stay, but not with superficial or deep infection in patients undergoing lumbar decompression procedures. Spine surgeons should remain vigilant regarding postoperative complications in patients on long-term corticosteroids, especially as it relates to UTI and propensity to decompensate into sepsis or septic shock. Thromboembolic risk attenuation is also imperative in this patient group during the postoperative period and the surgeon should weigh the risks and benefits of more intensive anticoagulation measures.  相似文献   
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BackgroundBecause primary squamous cell carcinoma (SCC) of the breast is a rare disease, the standard therapy has not been established. We examined the clinical outcomes of postoperative adjuvant radiotherapy for breast SCC.Material and methodsWe conducted a multicenter retrospective cohort study. Patients diagnosed with primary breast SCC who received adjuvant radiotherapy as part of their primary definitive treatment were included. Overall survival (OS), breast cancer-specific survival (BCSS), and recurrence-free interval (RFi) were evaluated.ResultsBetween January 2002 and December 2017, 25 breast SCC patients received adjuvant radiotherapy as a primary treatment were included. Median follow-up time was 43.5 months. Three (12%), fifteen (60%) and seven (28%) patients had clinical stage I, II and III disease, respectively. Fourteen patients underwent breast-conserving surgery and subsequent adjuvant radiotherapy. Eleven patients underwent mastectomy and post-mastectomy radiotherapy. Ten patients received regional lymph node irradiation. Nine (36%) patients had disease recurrence. The first site of recurrence was locoregional in five, but distant metastasis arose in one. Concurrent local and distant metastasis were seen in two. Six cases of local recurrence occurred within the irradiated site. Seven patients died, and six of the deaths were due to breast cancer. Five-year OS, BCSS, and Rfi were 69%, 70%, and 63%, respectively. In multivariate analysis, age and lymphatic invasion were associated with increased risk of recurrence.ConclusionBreast SCC has a high incidence of locoregional recurrence and poor prognosis. Age and lymphatic invasion are significant risk factors for recurrence.  相似文献   
20.
The Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) is an extensive reference terminology with an attendant amount of complexity. It has been updated continuously and revisions have been released semi-annually to meet users’ needs and to reflect the results of quality assurance (QA) activities. Two measures based on structural features are proposed to track the effects of both natural terminology growth and QA activities based on aspects of the complexity of SNOMED CT. These two measures, called the structural density measure and accumulated structural measure, are derived based on two abstraction networks, the area taxonomy and the partial-area taxonomy. The measures derive from attribute relationship distributions and various concept groupings that are associated with the abstraction networks. They are used to track the trends in the complexity of structures as SNOMED CT changes over time. The measures were calculated for consecutive releases of five SNOMED CT hierarchies, including the Specimen hierarchy. The structural density measure shows that natural growth tends to move a hierarchy’s structure toward a more complex state, whereas the accumulated structural measure shows that QA processes tend to move a hierarchy’s structure toward a less complex state. It is also observed that both the structural density and accumulated structural measures are useful tools to track the evolution of an entire SNOMED CT hierarchy and reveal internal concept migration within it.  相似文献   
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