Association between body mass index and folate insufficiency indicative of neural tube defects risk among nonpregnant women of childbearing age in the United States, NHANES, 2007-2010.

BACKGROUND: Maternal folate status and obesity are known risk factors for neural tube defects (NTD) in the offspring. We examined the association between body mass index (BMI) categories and blood folate concentrations, specifically, red blood cell (RBC) folate concentrations indicative of NTD risk among nonpregnant women of child-bearing age (20-44 years) in the United States. METHODS: We used data from 2007 to 2010 US National Health and Nutrition Examination Survey (NHANES). Overweight, obesity, and strata within obesity were examined. Serum and RBC folate concentrations were examined as continuous and categorical variables. RBC folate concentrations were grouped indicating high (≤585 nmol/L) and elevated risk (586-747 nmol/L) for NTDs. Unadjusted and adjusted prevalence odds ratios (aPOR) and their 95% confidence intervals (CI) were estimated using logistic regression. RESULTS: Of the 30,878 participants, 25.6% were overweight, 32.7% obese, and 32.3% had RBC folate concentration indicating NTD risk (<748 nmol/L). Overweight was not associated with RBC folate level for NTD risk; however, a marginally significant negative association was noted for overall obesity and RBC folate concentrations indicative of elevated NTD risk (aPOR = 0.76; 95% CI = 0.45, 1.00). A significant protective association was noted between Class 3 obesity (BMI ≥40 kg/m2 ) and folate concentration indicative of high NTD risk (≤585 nmol/L; aPOR = 0.46; 95% CI = 0.24, 0.89). CONCLUSIONS: The prevalence of RBC folate concentrations indicating elevated or high NTD risk varied by level of obesity among nonpregnant women of child-bearing age. Further studies are needed to understand the folate pathway in overweight and obese women and subsequent NTD risk in their offspring.

Factors affecting symptom presentation in an early-phase clinical trials clinic patient population.

Increasing numbers of oncology therapies are being approved based on early-phase single-arm studies. Yet, little is known regarding the use of patient-reported outcomes in single-arm oncology trials testing novel therapies. We examined patient-reported symptom severity and symptom interference with activity- (WAW: work, general activity, walking) and mood-(REM: relations with others, enjoyment of life, mood) related functioning, and their association with factors known to influence symptom severity reporting, in early-phase clinical trials clinic patients. Patients completed the validated MD Anderson Symptom Inventory, containing 13 severity items and six interference items, each rated on a 0-10 scale (higher scores = worse symptom severity/interference). Performance status (ECOG-PS) and age were ascertained. Multiple linear regression was performed. In 248 phase I patients (51% female, 90% ECOG 0-1, and 74% ≤65 years), 67% of patients had ≥seven concurrent symptoms of any severity level, and 51% of patients described ≥three concurrent symptoms as moderate-to-severe (severity rating ≥ 5). Composite symptom severity, WAW and REM were worse in patients with ECOG-PS ≥ 2 vs. 0-1, and worse in patients with ECOG-PS = 1 than in patients with ECOG-PS = 0. Compared with patients over 65y, adolescent and young adult (AYA) patients (18y-39y) and patients aged 40y to 65y had worse composite symptom severity. As expected, being employed full-time/retired was associated with better symptom profiles in phaseI patients. The variation of symptom burden by performance status and age suggest that these factors need to be considered in the design of early-phase trials, particularly if patient-reported symptoms are used as primary/secondary/exploratory endpoints.

Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial.

INTRODUCTION: Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation. METHODS AND ANALYSIS: In order to address this gap, we propose a prospective randomised trial of accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI) that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology (TeleRecovery) to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. ETHICS AND DISSEMINATION: RecoverMI has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial. TRIAL REGISTRATION NUMBER: NCT02613728; Pre-results.

Investigation of the Utility of the Audible Alert in Recent Generation Medtronic Implantable Cardioverter Defibrillators.

BACKGROUND: Medtronic implantable cardioverter defibrillators (ICDs; Medtronic Inc., Mounds View, MN, USA) are equipped with Patient Alert™, a feature in which the ICD generator emits a series of audible tones to notify patients of possible system malfunction. A prior study of this issue revealed that only 50% of patients with older Medtronic devices were able to hear alerts. More recently, Medtronic has incorporated modifications to the alert. Therefore, we studied how frequently alert tones emitted by the current generation of Medtronic ICDs are audible by patients. METHODS: A series of patients were evaluated in an outpatient ICD clinic. Alert tones were demonstrated using a device programmer in a quiet room and in the presence of low-level background noise. Patients reported whether they heard the tones, and they completed questionnaires regarding the tones. RESULTS: The total sample size was 100 patients, 81 male, who ranged from 29 years to 94 years of age (mean age 72.1 ± 11.8). Among the study subjects, 46% were older than 75 years, 41% were between 55 years and 75 years, and 13% were younger than 55 years. In the absence of background noise, 94% of patients were able to hear both alerts, 1% heard only one alert, and 5% heard neither. In the presence of background noise, 88% of patients heard both the alerts, 7% heard only one alert, and 5% heard neither alerts. CONCLUSIONS: Our results demonstrate that alert tones in recent generation Medtronic ICDs have improved audibility, compared to prior published data, among a large outpatient ICD population.