CD62L (L-selectin) shedding for assessment of functional blockade of TNF alpha in anti-TNF treated IBD patients: clinical feasibility and perspectives (DOP060)

Background Tumor necrosis factor (TNF) inhibition is central to the therapy of inflammatory bowel diseases (IBD). However, loss of response (LOR) is frequent and additional tests to help decision making with costly anti-TNF Therapy are needed. Methods Consecutive IBD Patients receiving anti-TNF therapy (Infliximab (IFX) or Adalimumab (after IFX LOR) from Bern University Hospital were identified and followed prospectively. Patient whole blood was stimulated with a dose-titration of two triggers of TLR receptors human: TNF and LPS. Median fluorescence intensity of CD62L on the surface of granulocytes was quantified by surface staining with specific antibodies (CD33, CD62L) and flow cytometry and logistic curves to these data permits the calculation of EC50 or the half maximal effective concentration TNF concentration to induce shedding [1]. A shift in the concentration were CD62L shedding occurred was seen before and after the anti-TNF agent administraion which permits to predict the response to the drug. This predicted response was correlated to the clinical evolution of the patients in order to analyze the ability of this test to identify LOR to IFX. Results We collected prospective clinical data and blood samples, before and after anti-TNF agent administration, on 33 IBD patients, 25 Crohn's disease and 8 ulcerative colitis patients (45% females) between June 2012 and November 2013. The assay showed a functional blockade of IFX (PFR) for 22 patients (17 CD and 5 UC) whereas 11 (8 CD and 3 UC) had no functional response (NR) to IFX. Clinical characteristics (e.g. diagnosis, disease location, smoking status, BMI and number of infusions) were no significantly different between predicted PFR and NR. Among the 22 Patients with PRF, only 1 patient was a clinical non responder (LOR to IFX), based on clinical prospective evaluation by IBD gastroenterologists (PJ, AM), and among the 11 predicted NR, 3 had no clinical LOR. Sensitivity of this test was 95% and specificity 73% and AUC adjusted for age and gender was 0.81 (Figure 1). During follow up (median 10 mo, 3–15) 8 “hard” outcomes occured (3 medic. flares, 4 resections and 1 new fistula) 2 in the PFR and 6 in the NR group (25% vs. 75%; p < 0.01). Correlation with clinical response is presented in Figure 2. Figure 1. Figure 2. Correlation clinical response - log EC50 changes: 1 No, 2 partial, 3 complete clinical response. Conclusion CD62L (L-Selectin) shedding is the first validated test of functional blockade of TNF alpha in anti-TNF treated IBD patients and will be a useful tool to guide medical decision on the use of anti-TNF agents. Comparative studies with ATI and trough level of IFX are ongoing. 1. Nicola Patuto, Emma Slack, Frank Seibold and Andrew J. Macpherson, (2011), Quantitating Anti-TNF Functionality to Inform Dosing and Choice of Therapy, Gastroenterology, 140 (5, Suppl. I), S689.

Intra-Rater and Inter-Rater Reliability of a Medical Record Abstraction Study on Transition of Care after Childhood Cancer.

BACKGROUND The abstraction of data from medical records is a widespread practice in epidemiological research. However, studies using this means of data collection rarely report reliability. Within the Transition after Childhood Cancer Study (TaCC) which is based on a medical record abstraction, we conducted a second independent abstraction of data with the aim to assess a) intra-rater reliability of one rater at two time points; b) the possible learning effects between these two time points compared to a gold-standard; and c) inter-rater reliability. METHOD Within the TaCC study we conducted a systematic medical record abstraction in the 9 Swiss clinics with pediatric oncology wards. In a second phase we selected a subsample of medical records in 3 clinics to conduct a second independent abstraction. We then assessed intra-rater reliability at two time points, the learning effect over time (comparing each rater at two time-points with a gold-standard) and the inter-rater reliability of a selected number of variables. We calculated percentage agreement and Cohen's kappa. FINDINGS For the assessment of the intra-rater reliability we included 154 records (80 for rater 1; 74 for rater 2). For the inter-rater reliability we could include 70 records. Intra-rater reliability was substantial to excellent (Cohen's kappa 0-6-0.8) with an observed percentage agreement of 75%-95%. In all variables learning effects were observed. Inter-rater reliability was substantial to excellent (Cohen's kappa 0.70-0.83) with high agreement ranging from 86% to 100%. CONCLUSIONS Our study showed that data abstracted from medical records are reliable. Investigating intra-rater and inter-rater reliability can give confidence to draw conclusions from the abstracted data and increase data quality by minimizing systematic errors.

Psychological distress in medical seeking ED care for somatic reasons: results of a systematic review

Objectives: The aim of this systematic literature review is to investigate (A) currently used instruments for assessing psychological distress, (B) the prevalence of psychological distress in medical emergency department (ED) patients with acute somatic conditions and (C) empirical evidence on how predictors are associated with psychological distress. Methods: We conducted an electronic literature search using three databases to identify studies that used validated instruments for detection of psychological distress in adult patients presented to the ED with somatic (non-psychiatric) complaints. From a total of 1688 potential articles, 18 studies were selected for in-depth review. Results: A total of 13 instruments have been applied for assessment of distress including screening questionnaires and briefly structured clinical interviews. Using these instruments, the prevalence of psychological distress detected in medical ED patients was between 4% and 47%. Psychological distress in general and particularly depression and anxiety have been found to be associated with demographic factors (eg, female gender, middle age) and illness-related variables (eg, urgency of triage category). Some studies reported that coexisting psychological distress of medical patients identified in the ED was associated with physical and psychological health status after ED discharge. Importantly, during routine clinical care, only few patients with psychological distress were diagnosed by their treating physicians. Conclusions: There is strong evidence that psychological distress is an important and prevalent cofactor in medically ill patients presenting to the ED with harmful associations with (subjective) health outcomes. To prove causality, future research should investigate whether screening and lowering psychological distress with specific interventions would result in better patient outcomes.

Evaluation of Medical Students’ Attitudes and Performance of Basic Surgery Skills in a Training Program Using Fresh Human skin, Excised During Body Contouring Surgeries

BACKGROUND: Learning surgical skills in the operating room may be a challenge for medical students. Therefore, more approaches using simulation to enable students to develop their practical skills are required. OBJECTIVES: We hypothesized that (1) there would be a need for additional surgical training for medical students in the pre-final year, and (2) our basic surgery skills training program using fresh human skin would improve medical students' surgical skills. DESIGN: We conducted a preliminary survey of medical students to clarify the need for further training in basic surgery procedures. A new approach using simulation to teach surgical skills on human skin was set up. The procedural skills of 15 randomly selected students were assessed in the operating room before and after participation in the simulation, using Objective Structured Assessment of Technical Skills. Furthermore, subjective assessment was performed based on students' self-evaluation. The data were analyzed using SPSS, version 21 (SPSS, Inc., Chicago, IL). SETTING: The study took place at the Inselspital, Bern University Hospital. PARTICIPANTS: A total of 186 pre-final-year medical students were enrolled into the preliminary survey; 15 randomly selected medical students participated in the basic surgical skills training course on the fresh human skin operating room. RESULTS: The preliminary survey revealed the need for a surgical skills curriculum. The simulation approach we developed showed significant (p < 0.001) improvement for all 12 surgical skills, with mean cumulative precourse and postcourse values of 31.25 ± 5.013 and 45.38 ± 3.557, respectively. The self-evaluation contained positive feedback as well. CONCLUSION: Simulation of surgery using human tissue samples could help medical students become more proficient in handling surgical instruments before stepping into a real surgical situation. We suggest further studies evaluating our proposed teaching method and the possibility of integrating this simulation approach into the medical school curriculum.

Thrombus formation in the left ventricle after large myocardial infarction – assessment with cardiac magnetic resonance imaging

INTRODUCTION Left ventricular thrombus (LVT) formation may worsen the post-infarct outcome as a result of thromboembolic events. It also complicates the use of modern antiplatelet regimens, which are not compatible with long-term oral anticoagulation. The knowledge of the incidence of LVT may therefore be of importance to guide antiplatelet and antithrombotic therapy after acute myocardial infarction (AMI). METHODS In 177 patients with large, mainly anterior AMI, standard cardiac magnetic resonance imaging (CMR) including cine and late gadolinium enhancement (LGE) imaging was performed shortly after AMI as per protocol. CMR images were analysed at an independent core laboratory blinded to the clinical data. Transthoracic echocardiography (TTE) was not mandatory for the trial, but was performed in 64% of the cases following standard of care. In a logistic model, 3 out of 61 parameters were used in a multivariable model to predict LVT. RESULTS LVT was detected by use of CMR in 6.2% (95% confidence interval [CI] 3.1%-10.8%). LGE sequences were best to detect LVT, which may be missed in cine sequences. We identified body mass index (odds ratio 1.18; p = 0.01), baseline platelet count (odds ratio 1.01, p = 0.01) and infarct size as assessed by use of CMR (odds ratio 1.03, p = 0.02) as best predictors for LVT. The agreement between TTE and CMR for the detection of LVT is substantial (kappa = 0.70). DISCUSSION In the current analysis, the incidence of LVT shortly after AMI is relatively low, even in a patient population at high risk. An optimal modality for LVT detection is LGE-CMR but TTE has an acceptable accuracy when LGE-CMR is not available.

The care of adults with congenital heart disease across the globe: Current assessment and future perspective

The number of adults with congenital heart disease (CHD) has increased markedly over the past few decades as a result of astounding successes in pediatric cardiac care. Nevertheless, it is now well understood that CHD is not cured but palliated, such that life-long expert care is required to optimize outcomes. All countries in the world that experience improved survival in CHD must face new challenges inherent to the emergence of a growing and aging CHD population with changing needs and medical and psychosocial issues. Founded in 1992, the International Society for Adult Congenital Heart Disease (ISACHD) is the leading global organization of professionals dedicated to pursuing excellence in the care of adults with CHD worldwide. Recognizing the unique and varied issues involved in caring for adults with CHD, ISACHD established a task force to assess the current status of care for adults with CHD across the globe, highlight major challenges and priorities, and provide future direction. The writing committee consisted of experts from North America, South America, Europe, South Asia, East Asia, and Oceania. The committee was divided into subgroups to review key aspects of adult CHD (ACHD) care. Regional representatives were tasked with investigating and reporting on relevant local issues as accurately as possible, within the constraints of available data. The resulting ISACHD position statement addresses changing patterns of worldwide epidemiology, models of care and organization of care, education and training, and the global research landscape in ACHD.

Medical educators: How they define themselves - Results of an international web survey.

BACKGROUND Little is known about medical educators' self-definition. AIMS The aim of this study is to survey an international community of medical educators focusing on the medical educators' self-definition. METHODS Within a comprehensive, web-based survey, an open question on the participants' views of how they would define a "medical educator" was sent to 2200 persons on the mailing list of the Association for Medical Education in Europe. The free text definitions were analysed using qualitative thematic analysis. RESULTS Of the, 200 medical educators invited to participate, 685 (31.1%) provided a definition of a "medical educator". The qualitative analysis of the free text definitions revealed that medical educators defined themselves in 13 roles, primarily as "Professional Expert", "Facilitator", "Information Provider", "Enthusiast", "Faculty Developer", "Mentor", "Undergraduate and Postgraduate Trainer", "Curriculum Developer", "Assessor and Assessment Creator", and "Researcher". CONCLUSIONS Our survey revealed that medical educators predominantly define themselves as "Professional Experts" and identified 12 further self-defined roles of a medical educator, several of which not to have been reported previously. The results can be used to further the understanding of our professional identity.

Assessment of Functioning when Conducting Occupational Capacity Evaluations - What is "Evidence-Based"?

Aim: Occupational capacity evaluations have previously been subject to criticism for lacking in quality and consistency. To the authors' knowledge, there is no clear consensus on the best way to formally assess functioning within capacity evaluations. In this review we investigated different instruments that are used to assess functioning in occupational capacity evaluations. Methods: Systematic review of the literature. Results: Though several instruments that assess functional capacity were found in our search, a specific validated instrument assessing occupational capacity as part of a larger psychiatric evaluation was not found. The limitations of the existing instruments on assessing functional capacity are discussed. Conclusion: Medical experts relying on instruments to conduct functional capacity evaluations should be cognizant of their limitations. The findings call for the development and use of an instrument specifically designed to assess the functional and occupational capacity of psychiatric patients, which is also likely to improve the quality of these reports.

Do multiple true-false items beat the commonly used one-best-answers questions regarding to the Ottawa Criteria for Good Assessment? Results of a literature review

Background: Multiple True-False-Items (MTF-Items) might offer some advantages compared to one-best-answer-questions (TypeA) as they allow more than one correct answer and may better represent clinical decisions. However, in medical education assessment MTF-Items are seldom used. Summary of Work: With this literature review existing findings on MTF-items and on TypeA were compared along the Ottawa Criteria for Good Assessment, i.e. (1) reproducibility, (2) feasibility, (3) validity, (4) acceptance, (5) educational effect, (6) catalytic effects, and (7) equivalence. We conducted a literature research on ERIC and Google Scholar including papers from the years 1935 to 2014. We used the search terms “multiple true-false”, “true-false”, “true/false”, and “Kprim” combined with “exam”, “test”, and “assessment”. Summary of Results: We included 29 out of 33 studies. Four of them were carried out in the medical field Compared to TypeA, MTF-Items are associated with (1) higher reproducibility (2) lower feasibility (3) similar validity (4) higher acceptance (5) higher educational effect (6) no studies on catalytic effects or (7) equivalence. Discussion and Conclusions: While studies show overall good characteristics of MTF items according to the Ottawa criteria, this type of question seems to be rather seldom used. One reason might be the reported lower feasibility. Overall the literature base is still weak. Furthermore, only 14 % of literature is from the medical domain. Further studies to better understand the characteristics of MTF-Items in the medical domain are warranted. Take-home messages: Overall the literature base is weak and therefore further studies are needed. Existing studies show that: MTF-Items show higher reliability, acceptance and educational effect; MTF-Items are more difficult to produce

Comparability of Outcome Frameworks in Medical Education: Implications for framework development

Background: The demand for international harmonization in medical education increases with the growing mobility of students and health professionals. Many medical societies and governmental offices have issued outcome frameworks (OF), which describe aims and contents of medical education based on competencies. These national standards affect the development of curricula as well as assessment and licensing procedures. Comparing OF and identifying factors that limit their comparability may thus foster international harmonization of medical education. Summary of Work: We conducted a systematic search for national OF in MedLine, EmBase and the internet. We included all OF in German or English that resulted from a national consensus process and were published or endorsed by a national society or governmental body. We extracted information in five predetermined categories: history of origin, audience, formal structure, medical schooling system and key terms. Summary of Results: Out of 1816 results, 13 OF were included into further analyses. OF reference each other, often without addressing existing differences (e.g. in target audiences). The two most cited OF are “CanMEDs” and “Scottish Doctor”. OF differ especially in their level of detail as well as in the underlying educational system. Discussion and Conclusions: Based on our results we propose a two-step blueprint for OF, that may help to establish comparability for internationally aligned key features – so-called “core competencies” – while at the same time allowing for necessary regional adaptations in terms of “secondary competencies”. Take-home messages: Considerable differences in at least five categories of OF currently hinder the comparability of outcome frameworks.

Computer-based summative assessment of clinical reasoning in clerkships: A mixed-method comparison of key feature problems with case-based multiple choice questions

Background: It is yet unclear if there are differences between using electronic key feature problems (KFPs) or electronic case-based multiple choice questions (cbMCQ) for the assessment of clinical decision making. Summary of Work: Fifth year medical students were exposed to clerkships which ended with a summative exam. Assessment of knowledge per exam was done by 6-9 KFPs, 9-20 cbMCQ and 9-28 MC questions. Each KFP consisted of a case vignette and three key features (KF) using “long menu” as question format. We sought students’ perceptions of the KFPs and cbMCQs in focus groups (n of students=39). Furthermore statistical data of 11 exams (n of students=377) concerning the KFPs and (cb)MCQs were compared. Summary of Results: The analysis of the focus groups resulted in four themes reflecting students’ perceptions of KFPs and their comparison with (cb)MCQ: KFPs were perceived as (i) more realistic, (ii) more difficult, (iii) more motivating for the intense study of clinical reasoning than (cb)MCQ and (iv) showed an overall good acceptance when some preconditions are taken into account. The statistical analysis revealed that there was no difference in difficulty; however KFP showed a higher discrimination and reliability (G-coefficient) even when corrected for testing times. Correlation of the different exam parts was intermediate. Conclusions: Students perceived the KFPs as more motivating for the study of clinical reasoning. Statistically KFPs showed a higher discrimination and higher reliability than cbMCQs. Take-home messages: Including KFPs with long menu questions into summative clerkship exams seems to offer positive educational effects.

Improving the Assessment of Communication Skills at the Swiss Federal Licensing Exam: Results of a Student's Needs Assessment

Introduction With a three year project the assessment of communication skills within the Swiss Federal Licensing Examinations (FLE) shall be improved. As a first step a needs assessment among communication experts and medical students of the Swiss Medical Faculties will be performed. In this presentation the results of the students’ needs assessment will be presented. Methods A bilingual student’s online questionnaire will be developed by an expert panel taking relevant literature, the Swiss Catalogue of Learning Objectives and other consensus statements for communication (e.g., the European and Basler consensus statements) into account. With a think aloud study response process validity evidence will be sought. The questionnaire will focus on the following topics related to communication skills: (1) What has been taught?, (2) What has been assessed in the faculty exams?, (3) What has been assessed in the FLE?, (4) What should have been assessed in the FLE and how should the assessment be improved? Results Results of the students’ needs assessment will be available by the end of 2015 and be presented. Conclusions/ Take-home message We hope for valuable input for improving the assessment of communications skills within the FLE also from the students’ side. Results of the needs assessment from the students and experts will be combined and taken as input for an international expert symposium on how to improve the communication skills assessment within the FLE.