MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial.

In women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ± ultrasound (MX ± US) increases sensitivity but decreases specificity. Screening with MRI alone is an alternative and potentially more cost-effective strategy. Here, we describe the study protocol and the characteristics of enrolled patients for MRIB feasibility, multicenter, randomized, controlled trial, which aims to compare MRI alone versus MX+US in women at intermediate breast cancer risk (aged 40-59, with a 15-30% BC-LTR and/or extremely dense breasts).

Predictors of Ocrelizumab Effectiveness in Patients with Multiple Sclerosis.

Data regarding effectiveness and safety of ocrelizumab in the post-marking setting are lacking. The aim of our study was to provide effectiveness and safety data of ocrelizumab treatment in patients with relapsing-remitting (RR-) and progressive multiple sclerosis (PMS) and to evaluate clinical and immunological predictors of early treatment response. In this single-center prospective observational study, we investigated effectiveness outcomes (time-to-confirmed disability worsening, time-to-first relapse, time-to-first evidence of MRI activity and time-to-first evidence of disease activity), clinical and immunological predictors of early treatment response, and incidence of adverse events (AEs).

The role of the clinical trial nurse in Italy.

Purpose: To assess the role of the Clinical Trials Nurse (CTN) and to evaluate the quality of the job performed by Clinical Trials Nurses (CTNs) in Italy.

Methods: The study design was descriptive. The sample included 30 CTNs in Italy who were involved in conducting clinical trials in the last years.

Validating a measure to delineate the clinical trials nursing role in Italy.

In Italy, the role of a nurse in cancer research is beginning to develop, but instruments developed to delineate the dimensions of the Italian clinical trials nursing role are lacking. This study aimed to translate into Italian the Clinical Trials Nursing Questionnaire (CTNQ) and assess its content validity, internal consistency, and stability reliability. Forward-backward translation and review by experts were performed to assess linguistic and content validation.