Patient-Reported Quality of Life Before and After Chemoradiation for Intact Pancreas Cancer: A Prospective Registry Study

PurposeOur purpose was to determine the effect of chemoradiotherapy (CRT) on patient-reported quality of life (QOL) for patients with intact pancreas cancer.Methods and MaterialsWe reviewed a prospective QOL registry for patients with intact, clinically localized pancreatic ductal adenocarcinoma treated with CRT between June 2015 and November 2018. QOL was assessed pre-CRT (immediately before CRT, after neoadjuvant chemotherapy) and at the completion of CRT with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and its component parts: FACT-General (FACT-G) and hepatobiliary cancer subscore (HCS). A minimally important difference from pre-CRT was defined as ≥ 6, 5, and 8 points for FACT-G, HCS, and FACT-Hep, respectively.ResultsOf 157 patients who underwent CRT, 100 completed both pre- and post-CRT surveys and were included in the primary analysis. Median age at diagnosis was 65 years (range, 23-90). National Comprehensive Cancer Network resectability status was resectable (3%), borderline resectable (40%), or locally advanced (57%). Folinic acid, 5-fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) (75%) or gemcitabine and nab-paclitaxel (42%) were given for a median of 6 cycles (range, 0-42) before CRT. Radiation therapy techniques included 3-dimensional conformal (22%), intensity modulated photon (55%), and intensity modulated proton (23%) radiation therapy to a median dose of 50 Gy (range, 36-62.5). Concurrent chemotherapy was most commonly capecitabine (82%). Sixty-three patients (63%) had surgery after CRT. The mean decline in FACT-G, HCS subscale, and FACT-Hep from pre- to post-CRT was 3.5 (standard deviation [SD], 13.7), 1.7 (SD 7.8), and 5.2 (SD 19.4), respectively. Each of these changes were statistically significant, but did not meet the minimally important difference threshold. Pancreatic head tumor location was associated with decline in FACT-Hep. Nausea was the toxicity with the greatest increase from pre- to post-CRT by both physician-assessment and patient-reported QOL.ConclusionsFor patients with intact pancreatic adenocarcinoma, modern CRT is well tolerated with minimal decline in QOL during treatment.     

The effects of hallux valgus and walking speed on dynamic balance in older adults

BackgroundHallux valgus (HV) contributes to deficits in static balance and increased fall risk in older adults. Very limited research has examined dynamic balance deficits in walking in this population. These individuals generally walk slowly, as balance challenge is lesser at slow speeds.Research questionHow does the dynamic balance of older adults with HV differ from healthy controls at controlled slow and fast walking speeds?MethodsNineteen older adults with HV and 13 healthy controls completed 5 continuous walking trials at 1.0 and 1.3 m·s⁻¹ as whole body marker position and ground reaction force data were captured. Dynamic balance was evaluated using whole body center of mass (COM) and center of pressure (COP) inclination angles (IA) and duration of double support.ResultsThere were no differences in measures of dynamic balance between older adults with and without HV at slow and fast speeds. At the faster speed, the peak sagittal plane COM-COP IA increased and the double support duration decreased, while the peak frontal plane COM-COP IA were not affected.SignificanceOlder adults with HV do not exhibit deficits in dynamic balance during continuous walking at comfortable speeds when compared to healthy older adults.     

Hormone exposure and its suppressive effect on risk of high-grade gliomas among patients with breast cancer

BackgroundPrior reports demonstrate the expression of estrogen and progesterone receptors in high-grade gliomas (HGGs), but the relationship between hormone receptor-positive disease and risk of HHGs in patients with breast cancer (BC) remains uncharacterized.MethodsUsing the SEER 18 registries (2000–2017), we examined the temporal trend of the incidence of HGGs and BC. The standardized incidence ratio was calculated to assess the risk of subsequent HGG in BC patients.ResultsDuring the study period, the incidence of BC and HGGs remained comparable for men and women. Among 976,134 patients with BC, we found a decreased incidence of HGGs in females, but not in males. Female BC patients with hormone receptor-positive disease were at a lower risk of developing glioblastoma and anaplastic astrocytoma.ConclusionOur study findings allude to the protective role of hormone exposure in the development of HGGs, which may lead to the development of therapies targeting hormonal pathways.     

Sleep-related problems and suicide behavior and ideation among Black and White trauma-exposed psychiatric inpatients

ObjectiveSleep-related problems (SRPs) are associated with increased risk for suicide-related behavior and death. Given that Black adults report greater SRPs as compared to White adults, the purpose of the current study was to examine sleep problems, suicide-related psychiatric admission, and suicide ideation, in Black and White trauma-exposed adults.MethodSuicide-related behavior (i.e., intent, plan, and/or behavior) as reason for hospital admission was obtained via medical records review for 172 Black and White adults who were admitted to an acute-care psychiatric facility; all participants completed validated measures of sleep quality and suicide ideation.ResultsAdjusted logistic regression analyses revealed that sleep-related daytime dysfunction (AOR = 4.32, p < .05) and poor sleep quality (AOR = 3.64, p < .05) were associated with significantly increased odds that Black participants were admitted for suicide-related psychiatric care. Poorer sleep quality (AOR = 2.10, p < .05) was also associated with increased odds of suicide-related admission among White participants. However, shorter sleep duration was marginally associated with suicide ideation in Black participants only.ConclusionsSRPs may be related to suicide-related behavior and ideation differently for vulnerable Black and White adults. More research is needed to understand potential race group differences and mechanisms by which SRPs increase risk for suicide crisis across racial groups.     

What makes a biostatistician?

Biostatisticians play an important role in medical research. They are co-responsible for an appropriate and efficient study design, they are involved in monitoring the study conduct, they plan and perform the data analysis, and they are involved in interpreting and publishing the results. However, how are the biostatisticians prepared for their tasks and responsibilities? Graduate programs in biostatistics are being offered, but some practicing biostatisticians completed their studies in a mathematical or epidemiological program, or obtained their degree in subject-specific fields (such as medicine or biology). Therefore, the expertise and the competencies can vary widely between the individual biostatisticians, also depending on the application field. In this article, focusing on European and US practices, we discuss the required professional expertise for the main areas of applications in the medical field as well as the necessary soft skill competencies of a biostatistician.     

Quantile regression and empirical likelihood for the analysis of longitudinal data with monotone missing responses due to dropout,with applications to quality of life measurements from clinical trials

The analysis of quality of life (QoL) data can be challenging due to the skewness of responses and the presence of missing data. In this paper, we propose a new weighted quantile regression method for estimating the conditional quantiles of QoL data with responses missing at random. The proposed method makes use of the correlation information within the same subject from an auxiliary mean regression model to enhance the estimation efficiency and takes into account of missing data mechanism. The asymptotic properties of the proposed estimator have been studied and simulations are also conducted to evaluate the performance of the proposed estimator. The proposed method has also been applied to the analysis of the QoL data from a clinical trial on early breast cancer, which motivated this study.     

Exclusion of Patients With Brain Metastases in Published Phase III Clinical Trials for Advanced Breast Cancer

Metastatic HER2-positive (HER2+) and triple-negative breast cancer (TNBC) confer a 30% or higher risk of developing brain metastases (BrM), but BrM is typically an exclusion criteria for clinical trials, which limits the generalizability of trial results to these patients. We therefore analysed trends in the enrollment of patients with BrM, as well as the use of outcomes specific to the central nervous system (CNS), in phase III clinical trials evaluating systemic therapy for patients with advanced HER2+ and/or TNBC. Notably, 10 of the 34 trials (29%, 95% confidence interval = 15.1%-47.5%) evaluated CNS-specific outcomes and trials that completely excluded patients with BrM were significantly less likely to meet their primary endpoint (n = 6/17, 35%) than those that permitted conditional enrollment (n = 13/15, 87%) (P = .005), suggesting that enrollment of patients with BrM is not detrimental to trial success.