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

Does adult ADHD interact with COMT val 158 met genotype to influence working memory performance?

Peer reviewedPostprin

From Genes to Behavior: The Impact of the COMT Val158Met Polymorphism on visual-spatial Attention Control in Emotional Processing

Der Catechol-O-Methyltransferase (COMT) Val158Met Polymorphismus (rs4680) ist am Abbau von Dopamin und Noradrenalin im menschlichen Gehirn beteiligt. In bisherigen Studien konnte gezeigt werden, dass das Met-Allel mit einer erhöhten Reaktivität auf negative Stimuli assoziiert ist. Auf Basis der Tonischen/ Phasischen Dopaminhypothese wird postuliert, dass diese erhöhte Reaktivität auf negative Reize durch defizitäre Disengagementprozesse verursacht sein könnte. Das Ziel dieser Arbeit war es daher, diese theoretische Annahme mithilfe von Blickbewegungsmessungen zu überprüfen und zu untersuchen, ob die erhöhte Reaktivität sich auch in verlängerten Disengagementlatenzen von negativen Reizen widerspiegelt. Es wurden dafür drei Studien durchgeführt, in denen eine adaptierte Version der emotionalen Antisakkadenaufgabe in Verbindung mit einer Blickbewegungsmessung eingesetzt wurde. In der zweiten Studie wurde zusätzlich eine EEG-Messung durchgeführt. Außerdem wurde in der dritten Studie die Aufmerksamkeitslokation manipuliert. In der ersten und zweiten Studie zeigte sich nicht wie erwartet ein linearer Effekt in Relation zum COMT Val158Met Polymorphismus, sondern ein Heterosiseffekt. Dieser Effekt zeigte sich nur in der einfacheren Prosakkadenbedingung. In der ersten Studie wurde der Heterosiseffekt bei negativen Reizen gefunden, wohingegen in der zweiten Studie der Heterosiseffekt nur in einer EEG- Komponente, der Early Posterior Negativity (EPN), aber sowohl bei positiven als auch negativen Reizen gefunden wurde. In der dritten Studie zeigte sich kein Genotypeffekt. Es wird vermutet, dass der COMT Effekt in der emotionalen Verarbeitung aufgabenspezifisch sein könnte und daher, neben linearen Zusammenhängen, unter bestimmten Umständen auch ein Heterosiseffekt auftreten kann. Die Ergebnisse sollten nicht auf eine männliche Stichprobe generalisiert werden, da in allen Studien lediglich weibliche Versuchspersonen teilnahmen.The catechol-O-methyltransferase (COMT) Val158Met polymorphism (rs4680) moderates dopamine and norepinephrine degradation in the prefrontal cortex. It has been shown that the Met-Allele is associated with an increased reactivity to negative stimuli. With regard to the tonic-phasic dopamine model it is hypothesized that this increased reactivity to negative stimuli derives from deficient disengagement from negative stimuli. The aim of this work was therefore to investigate whether this increased reactivity is reflected in prolonged disengagement from negative pictures. Three studies were conducted, in which an adapted version of the emotional antisaccade task in combination with Eye Tracking was used. This paradigm allows for varying task difficulty. In the second study additionally an EEG measurement was recorded. Furthermore, in the third study the location of the attention was manipulated. Unexpectedly, in the first and second study we did not find a linear effect in relation to the COMT polymorphism, but a heterosis effect. This effect was found only in the simpler Prosaccade condition. In the first study the heterosis effect was found for negative stimuli, whereas in the second study the heterosis effect was found for positive as well as negative stimuli in one EEG component, the Early Posterior Negativity (EPN). The third study yielded no Genotype effect. It is suggested that the COMT effect on emotional processing is task-specific and therefore besides linear effects a heterosis effect might also occur under certain circumstances. In all three studies, only female subjects participated. Therefore the results should not be generalized to a male sample

Prefrontal Brain Activation During Emotional Processing: A Functional Near Infrared Spectroscopy Study (fNIRS)

The limbic system and especially the amygdala have been identified as key structures in emotion induction and regulation. Recently research has additionally focused on the influence of prefrontal areas on emotion processing in the limbic system and the amygdala. Results from fMRI studies indicate that the prefrontal cortex (PFC) is involved not only in emotion induction but also in emotion regulation. However, studies using fNIRS only report prefrontal brain activation during emotion induction. So far it lacks the attempt to compare emotion induction and emotion regulation with regard to prefrontal activation measured with fNIRS, to exclude the possibility that the reported prefrontal brain activation in fNIRS studies are mainly caused by automatic emotion regulation processes. Therefore this work tried to distinguish emotion induction from regulation via fNIRS of the prefrontal cortex. 20 healthy women viewed neutral pictures as a baseline condition, fearful pictures as induction condition and reappraised fearful pictures as regulation condition in randomized order. As predicted, the view-fearful condition led to higher arousal ratings than the view-neutral condition with the reappraise-fearful condition in between. For the fNIRS results the induction condition showed an activation of the bilateral PFC compared to the baseline condition (viewing neutral). The regulation condition showed an activation only of the left PFC compared to the baseline condition, although the direct comparison between induction and regulation condition revealed no significant difference in brain activation. Therefore our study underscores the results of previous fNIRS studies showing prefrontal brain activation during emotion induction and rejects the hypothesis that this prefrontal brain activation might only be a result of automatic emotion regulation processes

How does a Shared Decision-Making (SDM) intervention for oncologists affect participation style and preference matching in patients with breast and colon cancer?

The aims of this study are to assess patients’ preferred and perceived decision-making roles and preference matching in a sample of German breast and colon cancer patients and to investigate how a shared decision-making (SDM) intervention for oncologists influences patients’ preferred and perceived decision-making roles and the attainment of preference matches. This study is a post hoc analysis of a randomised controlled trial (RCT) on the effects of an SDM intervention. The SDM intervention was a 12-h SDM training program for physicians in combination with decision board use. For this study, we analysed a subgroup of 107 breast and colon cancer patients faced with serious treatment decisions who provided data on specific questionnaires with regard to their preferred and perceived decision-making roles (passive, SDM or active). Patients filled in questionnaires immediately following a decision-relevant consultation (t1) with their oncologist. Eleven of these patients’ 27 treating oncologists had received the SDM intervention within the RCT. A majority of cancer patients (60%) preferred SDM. A match between preferred and perceived decision-making roles was reached for 72% of patients. The patients treated by SDM-trained physicians perceived greater autonomy in their decision making (p < 0.05) with more patients perceiving SDM or an active role, but their preference matching was not influenced. A SDM intervention for oncologists boosted patient autonomy but did not improve preference matching. This highlights the already well-known reluctance of physicians to engage in explicit role clarification

Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial

BackgroundPatients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients' knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction.MethodsIn total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T-0; after intervention, T-1; and 3 months after intervention, T-2). The main outcome is the patient's knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T-1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T-1 and T-2.DiscussionThis trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma.Trial registrationClinicalTrials.gov NCT04240717. Registered on 27 January 202