Development, implementation, and evaluation of a curriculum for medical students on conflicts of interest and communicating risk.

Background: Insufficient risk competence of physicians, conflicts of interests from interactions with pharmaceutical companies, and the often distorted presentation of benefits and risks of therapies compromise the advising of patients by physicians in the framework of shared decision-making. An important cause of this is that teaching on this subject is mostly lacking, or fragmented when it does take place [1], [2], [3], [4]. Even though the German National Competence-Based Catalog of Learning Goals in Medicine defines learning goals on the topics of conflicts of interest and communication of risk, there are no classes that integrate both topics. Our goal was to develop a model curriculum to teach conflicts of interest and communication of risk that would integrate statistical know-how, communicational competency on the presentation of benefits and risks, and the meaning and management of conflicts of interest. Project Description: The development of the curriculum took place according to the six-step cycle of Kern et al [5]. An integrated curriculum was conceptualized, piloted, and adapted with the support of experts for the topics of shared decision-making, conflicts of interest, and communication of risk. The final version of the curriculum was implemented at the medical schools of Mainz and Heidelberg and evaluated by the students. Results: The final curriculum consists of 19 lesson units. The contents are the fundamentals of statistics, theory of risk communication, practical exercises on communication of risk, and the fundamentals of the mechanisms of effect of conflicts of interest, recognition of distortions in data, and introductions to professional management of conflicts of interest. The course was implemented three times at two different medical schools with a total of 32 students, and it was positively rated by most of the 27 participating students who evaluated it on the 1-6 German school grading scale (mean: 1.4; SD: 0.49; range: 1-2). Discussion: The curriculum we developed fills a gap in the current medical education. The innovative concept, which sensibly connects the transmission of theory and practice, was positively received by the students. The next steps are an evaluation of the curriculum by means of a two-center randomized study and the implementation at German and international medical schools. The process should be accompanied by continuous evaluation and further improvement.

Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.

BACKGROUND: Risk communication is a core aspect of a physician's work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI). OBJECTIVE: To evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions. DESIGN: A rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers. PARTICIPANTS: Sixty-three medical students in their fourth or fifth year. INTERVENTIONS: Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual. MAIN MEASURES: Primary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE). KEY RESULTS: Participants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen's d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group (d between 0.91 and 2.04 (p < 0.001)). CONCLUSIONS: Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge. TRIAL REGISTRATION: The trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.

Expression analysis of aldehyde dehydrogenase 1A1 (ALDH1A1) in colon and rectal cancer in association with prognosis and response to chemotherapy.

BACKGROUND: Aldehyde dehydrogenase 1A1 (ALDH1A1) has been described as a cancer stem cell marker and as a regulator of cellular chemoresistance. Therefore, ALDH1A1 has been suggested as potential biomarker to stratify patients into different risk categories for a "personalized" therapy approach. We have investigated the prognostic role of ALDH1A1 in primary colorectal cancer and its value in predicting response to chemotherapy in metastatic colorectal cancer. METHODS: Immunostaining against ALDH1A1 was performed on a paraffin-embedded tissue microarray including 659 primary colon cancer samples and 338 rectal cancer samples. Likewise, tissue of 44 palliatively resected colorectal liver metastases on whole-mount tissue slides was immunostained against ALDH1A1. Cytoplasmic, nuclear, and stromal expression of ALDH1A1 was assessed and merged with histopathological and clinical data. RESULTS: Univariate and multivariate analysis revealed that cytoplasmic and stromal expression of ALDH1A1 is not significantly associated with prognosis either in colon or in rectal cancer. Furthermore, cytoplasmic expression of ALDH1A1 does not predict response to palliative chemotherapy in patients with metastatic diseases. Intriguingly, as a novel finding, nuclear expression of ALDH1A1 was observed in a small subgroup of patients with colon cancer and rectal cancer. In colon cancer, nuclear expression was significantly associated with shortened overall survival by univariate and multivariate analysis. CONCLUSIONS: Immunohistochemical expression analysis of ALDH1A1 in colon cancer is useful for the detection of nuclear expression in a small subpopulation of patients and is associated with shorter survival. Cytoplasmic expression fails to be of clinical relevance as prognostic or predictive marker in colorectal cancer.