Impact of Availability of Immediate Breast Reconstruction on Bilateral Mastectomy Rates for Breast Cancer across the United States: Data from the Nationwide Inpatient Sample

Background

Availability of immediate breast reconstruction (IBR) varies among institutions, yet the impact of IBR availability on the rates of bilateral mastectomy (BM) versus unilateral mastectomy (UM) for breast cancer is unknown.

Methods

From the 2002 to 2010 Nationwide Inpatient Sample, we identified women with breast cancer undergoing UM or BM with and without IBR using ICD-9 codes. Hospitals were classified as performing IBR if at least one hospitalization included both mastectomy and reconstruction and then by IBR volume. Statistical comparisons utilized Chi square tests, tests for trend, and multivariable logistic regression.

Results

We identified 130,420 women undergoing UM (76.9 %) or BM (23.1 %) for breast cancer. Of 6,579 hospitals, 3,358 (51.0 %) performed no IBRs, while in the remaining 3,221 hospitals, 1 to 638 IBRs were performed per year. Large, teaching, urban, and Northeastern hospitals were more likely to have higher IBR volumes. BM rates were significantly higher in patients treated at those hospitals with higher IBR volumes, from 33.1 % at hospitals performing ≥24 IBRs per year to 9.0 % at hospitals without IBR (p < 0.001). Upon adjusted analysis, patients who elected BM were more likely to be seen at hospitals performing ≥24 IBRs per year (odds ratio 1.69 vs. UM, p < 0.001).

Conclusions

In this analysis of national data, BM rates were higher in hospitals where IBR was available, suggesting a significant influence of institutional factors on treatment options for breast cancer patients. Efforts are needed to ensure patients have access to IBR when desired and to better understand the reasons for hospital variation in BM rates.     

Micropapillary bladder cancer: Current treatment patterns and review of the literature

ObjectivesNo guidelines exist for the management of micropapillary bladder cancer (MPBC) and most reports of this variant of urothelial carcinoma are case series comprising small numbers of patients. We sought to determine current practice patterns for MPBC using a survey sent to the Society of Urologic Oncology (SUO) and to present those results in the setting of a comprehensive review of the existing literature.Materials and methodsA survey developed by the Translational Science Working Group of the Bladder Cancer Advocacy Network–sponsored Think Tank meeting was distributed to members of the SUO. The results from 118 respondents were analyzed and presented with a literature review.ResultsMost survey respondents were urologists, with 80% considering bladder cancer their primary area of interest. Although 78% of the respondents reported a dedicated genitourinary pathologist at their institution, there were discrepant opinions on how a pathologic diagnosis of MPBC is determined as well as variability on the proportion of MPBC that is clinically significant. Among them, 78% treat MPBC differently than conventional urothelial carcinoma, with 81% reporting that they would treat cT1 MPBC with upfront radical cystectomy. However, the respondents had split opinions regarding the sensitivity of MPBC to cisplatin-based chemotherapy, which affected utilization of neoadjuvant chemotherapy in muscle-invasive disease.ConclusionsThe management of MPBC is diverse among members of the SUO. Although most favors early cystectomy for cT1 MPBC, there is no consensus on the use of neoadjuvant chemotherapy for muscle-invasive MPBC.     

Moving towards multiple site outcomes in spinal cord injury pain clinical trials: An issue of clustered observations in trial design and analysis

Introduction

Pain remains a problem for many with spinal cord injury (SCI), and there is a need for sound, randomized clinical trials examining the efficacy of existing and novel therapeutics. SCI-related pain is complex, as more than one type of pain is often experienced. The purpose of this report is to (i) demonstrate how to design and power calculation of a clinical trial of SCI pain using multiple pain sites per individual; (ii) discuss consequences of failing to adjust for this; and (iii) provide intraclass correlation (ICC) estimates for common pain outcome measures that may be used to power future clinical trials in SCI pain.

Method

Using an existing dataset from a past SCI pain clinical trial, the ICC was calculated for common pain outcome measures to illustrate appropriate corrections for powering, analyzing and interpreting results from multiple pain sites per individual. The problem associated with not accounting for multiple pain sites per individual and the effect on the Type I error rate is also shown.

Results and Discussion

Not accounting for the ICC can lead to (1) incorrect power estimates in the design of a trial, and (2) an inflated Type I error rate with a higher likelihood of misinterpretation of outcomes.

Conclusions

Powering for future SCI pain trials and statistical analysis of trial outcomes may be substantially compromised if methods do not account for the intra-individual associations between pain sites, ultimately affecting study interpretations and evidence-based practice. We present ICC estimates based on SCI pain data for purposes of estimating power for future trials.     

Relationships between impulsivity and subjective response in an IV ethanol paradigm

Rationale

Impulsivity and individual differences in subjective response to alcohol are risk factors for alcohol problems and possibly endophenotypes for alcohol dependence. Few prior studies have addressed relationships between the two constructs.

Objectives

To predict subjective responses to ethanol, we tested self-reported impulsiveness, ethanol dose condition (high dose, low dose, or placebo), and time (seven time points) along with interactions among these variables.

Methods

The present study is a secondary analysis of data from a within-subject, placebo-controlled, dose-ranging ethanol administration study using IV infusion with a clamping technique to maintain steady-state breath alcohol concentration. The sample consisted of healthy, non-alcohol dependent social alcohol drinkers between the ages of 21 and 30 (N?=?105). Participants at varying levels of impulsivity were compared with regard to stimulant and subjective responses to three ethanol dose conditions over time.

Results

Individuals with higher impulsivity reported elavated stimulant and dampened sedative response to alcohol, particularly at the higher dose. Higher impulsivity was associated with a steeper increase in stimulant effects during the first half of clamped ethanol infusion with the higher dose.

Conclusions

These results suggest that impulsive individuals may experience enhanced reinforcing, stimulant effects, and relatively muted aversive sedative effects from alcohol. These subjective responses may relate to enhanced risk of alcohol problems among more impulsive individuals.     

Clinical Research Strategies for Fructose Metabolism

Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13–14 November 2012, “Research Strategies for Fructose Metabolism,” to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose.