Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training

Background: Oncological patients often feel left out of important treatment decisions. However, when physicians engage them in shared decision-making (SDM), patients benefit in many ways and the situation is improved. SDM can effectively be taught to physicians, but participation barriers for SDM physician group trainings are high, making it hard to convince physicians to participate. With this in mind, we aim to develop and evaluate two new dissemination strategies for a brief, SDM training program based upon a proven SDM group-training concept: an individualized context-based SDM face-to-face training (IG I) and a web-based interactive SDM online training (IG II). We aim to analyze which improvements can be achieved by IG I and II compared to a control group (CG) in physician SDM competence and performance as well as the impact on the physician-patient relationship. Furthermore, we analyze differences in satisfaction concerning the two dissemination strategies by means of a training evaluation. Methods/design: We examine – based on a three-armed randomized controlled trial (IG I, IG II, CG) – the effectiveness of two new dissemination strategies for a SDM training program compared to a CG receiving no SDM training (voluntary access to SDM training as an incentive for participation after completion of the study). We aim to include 162 physicians randomized to one of the three arms. There will be two assessment points in time (before intervention: T0 and post-training: T1). The main outcome is the SDM competence of physicians as measured by an established observational assessment rating system (OPTION-12) by means of consultations with Standardized Patients. Standardized Patients are individuals trained to act as “real” patients. Secondary outcome measures are the SDM performance (SDM-Q-9) and the Questionnaire on the Quality of Physician-Patient-Interaction (QQPPI) both rated by Standardized Patients as well as the physicians’ training evaluation. Discussion: This trial will assess the effectiveness and acceptability of two new dissemination strategies for a brief, SDM training program for physicians. Opportunities and challenges regarding implementation in daily routines will be discussed. Trial registration: ClinicalTrials.gov, Identifier: NCT02674360. Prospectively registered on 4 February 2016

Genome-wide association study identifies a variant in HDAC9 associated with large vessel ischemic stroke

Genetic factors have been implicated in stroke risk but few replicated associations have been reported. We conducted a genome-wide association study (GWAS) in ischemic stroke and its subtypes in 3,548 cases and 5,972 controls, all of European ancestry. Replication of potential signals was performed in 5,859 cases and 6,281 controls. We replicated reported associations between variants close to PITX2 and ZFHX3 with cardioembolic stroke, and a 9p21 locus with large vessel stroke. We identified a novel association for a SNP within the histone deacetylase 9(HDAC9) gene on chromosome 7p21.1 which was associated with large vessel stroke including additional replication in a further 735 cases and 28583 controls (rs11984041, combined P = 1.87×10−11, OR=1.42 (95% CI) 1.28-1.57). All four loci exhibit evidence for heterogeneity of effect across the stroke subtypes, with some, and possibly all, affecting risk for only one subtype. This suggests differing genetic architectures for different stroke subtypes

Real-Time fMRI Neurofeedback in Patients With Tobacco Use Disorder During Smoking Cessation: Functional Differences and Implications of the First Training Session in Regard to Future Abstinence or Relapse

One of the most prominent symptoms in addiction disorders is the strong desire to consume a particular substance or to show a certain behavior (craving). The strong association between craving and the probability of relapse emphasizes the importance of craving in the therapeutic process. Former studies have demonstrated that neuromodulation using real-time fMRI (rtfMRI) neurofeedback (NF) can be used as a treatment modality in patients with tobacco use disorder. The aim of the present project was to determine whether it is possible to predict the outcome of NF training plus group psychotherapy at the beginning of the treatment. For that purpose, neuronal responses during the first rtfMRI NF session of patients who remained abstinent for at least 3 months were compared to those of patients with relapse. All patients were included in a certified smoke-free course and took part in three NF sessions. During the rtfMRI NF sessions tobacco-associated and neutral pictures were presented. Subjects were instructed to reduce their neuronal responses during the presentation of smoking cues in an individualized region of interest for craving [anterior cingulate cortex (ACC), insula or dorsolateral prefrontal cortex]. Patients were stratified to different groups [abstinence (N = 10) vs. relapse (N = 12)] according to their individual smoking status 3 months after the rtfMRI NF training. A direct comparison of BOLD responses during the first NF-session of patients who had remained abstinent over 3 months after the NF training and patients who had relapsed after 3 months showed that patients of the relapse group demonstrated enhanced BOLD responses, especially in the ACC, the supplementary motor area as well as dorsolateral prefrontal areas, compared to abstinent patients. These results suggest that there is a probability of estimating a successful withdrawal in patients with tobacco use disorder by analyzing the first rtfMRI NF session: a pronounced reduction of frontal responses during NF training in patients might be the functional correlate of better therapeutic success. The results of the first NF sessions could be useful as predictor whether a patient will be able to achieve success after the behavioral group therapy and NF training in quitting smoking or not