Comprehensive Validation Study of Quality-of-Life Questionnaire Using Objective Clinical Measures: Breast Cancer Treatment Outcome Scale (BCTOS), Brazilian Portuguese Version

Introduction

When evaluating a quality-of-life questionnaire (QLQ), many validation studies do not correlate quality-of-life scores with objective measurements of complications associated with treatment.

Rare patients in routine care: Treatment and outcome in advanced papillary renal cell carcinoma in the prospective German clinical RCC-Registry

Non-clear cell renal cell carcinoma is a very rare malignancy that includes several histological subtypes. Each subtype may need to be addressed separately regarding prognosis and treatment; however, no Phase III clinical trial data exist. Thus, treatment recommendations for patients with non-clear cell metastatic RCC (mRCC) remain unclear. We present first prospective data on choice of first- and second-line treatment in routine practice and outcome of patients with papillary mRCC. From the prospective German clinical cohort study (RCC-Registry), 99 patients with papillary mRCC treated with systemic first-line therapy between December 2007 and May 2017 were included. Prospectively enrolled patients who had started first-line treatment until May 15, 2016, were included into the outcome analyses (n = 82). Treatment was similar to therapies used for clear cell mRCC and consisted of tyrosine kinase inhibitors, mechanistic target of rapamycin inhibitors and recently checkpoint inhibitors. Median progression-free survival from start of first-line treatment was 5.4 months (95% confidence interval [CI], 4.1–9.2) and median overall survival was 12.0 months (95% CI, 8.1–20.0). At data cutoff, 73% of the patients died, 6% were still observed, 12% were lost to follow-up, and 9% were alive at the end of the individual 3-year observation period. Despite the lack of prospective Phase III evidence in patients with papillary mRCC, our real-world data reveal effectiveness of systemic clear cell mRCC therapy in papillary mRCC. The prognosis seems to be inferior for papillary compared to clear cell mRCC. Further studies are needed to identify drivers of effectiveness of systemic therapy for papillary mRCC.     

Telemedicine to follow patients in a general surgery department. A randomized controlled trial

BackgroundTelemedicine is becoming more popular in many medical specialties but few studies have been conducted in General Surgery. This study aims to evaluate the feasibility of its introduction in this specialty.MethodsA prospective randomized clinical trial (RCT) was conducted in 200 patients to compare conventional vs telemedicine follow-up in the outpatient clinics. The primary outcome was the feasibility of telemedicine follow-up and the secondary outcomes were its clinical impact and patient satisfaction.ResultsPatients were enrolled between March 2017 and April 2018 and there were no statistically significant differences between the groups’ characteristics. The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003). No differences were found in clinical outcomes (P = 0.832) or patient satisfaction (P = 0.099).ConclusionTelemedicine is a good complementary service to facilitate follow-up management in selected patients from a General Surgery department.     

Development of a Cardiovascular Disease Risk Prediction Model Using the Suita Study,a Population-Based Prospective Cohort Study in Japan

Aim: To construct a risk prediction model for cardiovascular disease (CVD) based on the Suita study, an urban Japanese cohort study, and compare its accuracy against the Framingham CVD risk score (FRS) model.Methods: After excluding participants with missing data or those who lost to follow-up, this study consisted of 3,080 men and 3,470 women participants aged 30–79 years without CVD at baseline in 1989–1999. The main outcome of this study was incidence of CVD, defined as the incidence of stroke or coronary heart disease. Multivariable Cox proportional hazards models with stepwise selection were used to develop the prediction model. To assess model performance, concordance statistics (C-statistics) and their 95% confidence intervals (CIs) were calculated using a bootstrap procedure. A calibration test was also conducted.Results: During a median follow-up period of 16.9 years, 351 men and 241 women developed CVD. We formulated risk models with and without electrocardiogram (ECG) data that included age, sex, systolic blood pressure, diastolic blood pressure, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, lowdensity lipoprotein cholesterol, diabetes mellitus, smoking, and urinary protein as risk factors. The C-statistics of the Suita CVD risk models with ECG data (0.782; 95% CI, 0.766–0.799) and without ECG data (0.781; 95% CI, 0.765–0.797) were significantly higher than that of the FRS model (0.768; 95% CI, 0.750–0.785).Conclusions: The Suita CVD risk model is feasible to use and improves predictability of the incidence of CVD relative to the FRS model in Japan.     

An ode to fetal,infant, and toddler neuroimaging: Chronicling early clinical to research applications with MRI,and an introduction to an academic society connecting the field

Fetal, infant, and toddler neuroimaging is commonly thought of as a development of modern times (last two decades). Yet, this field mobilized shortly after the discovery and implementation of MRI technology. Here, we provide a review of the parallel advancements in the fields of fetal, infant, and toddler neuroimaging, noting the shifts from clinical to research use, and the ongoing challenges in this fast-growing field. We chronicle the pioneering science of fetal, infant, and toddler neuroimaging, highlighting the early studies that set the stage for modern advances in imaging during this developmental period, and the large-scale multi-site efforts which ultimately led to the explosion of interest in the field today. Lastly, we consider the growing pains of the community and the need for an academic society that bridges expertise in developmental neuroscience, clinical science, as well as computational and biomedical engineering, to ensure special consideration of the vulnerable mother-offspring dyad (especially during pregnancy), data quality, and image processing tools that are created, rather than adapted, for the young brain.     

Étude exploratoire de la santé musculo-squelettique du rachis d’étudiants en ostéopathie

BackgroundDuring their training, students in osteopathy regularly undergo spinal manipulation exercises. This exposes the students’ spine to unskilled gestures performed by their colleagues learning spinal manipulation. Discomfort, muscle soreness or moderate pain following spinal manipulations lasting two or three days are commonly reported. In addition, some students may have ongoing spinal musculoskeletal disease (SMSD) during their studies. The purpose of this study was to evaluate the prevalence of SMSDs and their maximum intensity in a population of osteopathy students and to determine whether individual differences exist.MethodAn exploratory cross-sectional study took place over three years. Data were collected by means of a self-administrated standardised questionnaire screening for MSD: the Nordic questionnaire.ResultsThere were 733 exploitable questionnaires, giving an average response rate of 91.5%. Average prevalence of SMSD was 98.4% during the last 12 months. Average maximum intensity perceived was 6/10 and 45% of students experienced an intense SMSD (scored between 7 and 10/10). Variation of the maximum intensity of SMSD between “before osteopathy studies” and “the last 12 months” was 1.2/10. This variation was influenced by the number of days students were manipulated during a week (p < 0.0001). On average, students underwent manipulation three days a week.ConclusionThis study confirms the important prevalence of SMSD among osteopathy students. This result led us to carry out a qualitative study for exploring students’ conceptions in health and spinal manipulative practices.