In the face of growing transplant waitlists and aging donors, sound pre-transplant evaluation of organ offers is paramount. However, many transplant centres lack clear criteria on organ acceptance. Often, previous scores for donor characterisation have not been validated for the Eurotransplant population and are not established to support graft acceptance decisions. Here, we investigated 1353 kidney transplantations at three different German centres to develop and validate novel statistical models for the prediction of early adverse graft outcome (EAO), defined as graft loss or CKD ≥4 within three months. The predictive models use generalised estimating equations (GEE) accounting for potential correlations between paired grafts from the same donor. Discriminative accuracy and calibration were determined via internal and external validation in the development (935 recipients, 309 events) and validation cohort (418 recipients, 162 events) respectively. The expert model is based on predictor ratings by senior transplant nephrologists, while for the data-driven model variables were selected via high-dimensional lasso generalised estimating equations (LassoGee). Both models show moderate discrimination for EAO (C-statistic expert model: 0,699, data-driven model 0,698) with good calibration. In summary, we developed novel statistical models that represent current clinical consensus and are tailored to the older deceased donor population. Compared to KDRI, our described models are sparse with only four and three predictors respectively and account for paired grafts from the same donor, while maintaining a discriminative accuracy equal or better than the established KDRI-score.

IntroductionThe impact of deceased donor characteristics on kidney transplant outcomes is controversial. Correspondingly, the predictive performance of deceased donor scores remains moderate, and many transplant centers lack validated criteria for graft acceptance decisions. To better dissect donor-related risk from recipient and periprocedural variables, we analyzed outcomes of kidney donor pairs transplanted in different individuals.MethodsThis study explored (a)symmetry of early outcomes of 328 cadaveric kidney transplant recipients from 164 donor pairs transplanted at three Eurotransplant centers. The primary discriminatory factor was (a)symmetry of partner graft function, defined as early graft loss or impaired graft function [estimated glomerular filtration rate (eGFR) <30 mL/min] 3 months after transplantation. We reasoned that a relevant impact of donor factors would result in a high concordance rate of limited graft function or failure.ResultsThe observed number of symmetric graft failure after transplantation was less than statistically expected (3 months: 1 versus 2, p = 0.89; and 12 months: 3 versus 5, p = 0.26). However, we found a trend toward an impaired 5-year graft survival of grafts with good function 3 months after transplantation but a failed or impaired partner graft compared to symmetrically well-functioning grafts (p = 0.09). Subsequently, we explored the impact of individual donor and recipient variables on early transplant outcomes. Generalized estimating equations after feature selection with LassoGEE bootstrap selected donor age, donor body mass index, and donor eGFR as the relevant risk factors.DiscussionOur findings indicate that donor factors impact early outcomes in kidney transplantation but may have a limited role in long-term graft survival, once a graft has been accepted for transplantation. Utilizing donor-based clinical scores has the potential to aid clinicians in acceptance decisions, giving them an estimate of individual posttransplant outcomes. However, the ultimate decision for acceptance should rest with clinicians, who must consider the complex interplay of donor factors, as well as recipient and periprocedural characteristics.

BACKGROUND:Kidney graft rejections are classified based on the Banff classification. The RejectClass algorithm, initially derived from a cohort comprising mostly protocol biopsies, identifies data-driven phenotypes of acute rejection and chronic pathology using Banff lesion scores. It also provides composite scores for inflammation activity and chronicity. This study independently evaluates the performance of RejectClass in a cohort consisting entirely of indication biopsies. METHODS:We retrospectively applied RejectClass to 441 patients from the German TRABIO (TRAnsplant BIOpsies) cohort who had received indication biopsies. The primary endpoint was death-censored graft failure during 2 y of follow-up. RESULTS:The application of RejectClass to our cohort demonstrated moderately comparable phenotypic features with the derivation cohort, and most clusters indicated an elevated risk of graft loss. However, the reproduction of all phenotypes and the associated risks of graft failure, as depicted in the original studies, was not fully accomplished. In contrast, adjusted Cox proportional hazards analyses substantiated that both the inflammation score and the chronicity score are independently associated with graft loss, exhibiting hazard ratios of 1.7 (95% confidence interval, 1.2-2.3; P = 0.002) and 2.2 (95% confidence interval, 1.8-2.6; P < 0.001), respectively, per 0.25-point increment (scale: 0.0-1.0). CONCLUSIONS:The composite inflammation and chronicity scores may already have direct utility in quantitatively assessing the disease stage. Further refinement and validation of RejectClass clusters are necessary to achieve more reliable and accurate phenotyping of rejection.

Background:The administration of modified immune cells (MIC) before kidney transplantation led to specific immunosuppression against the allogeneic donor and a significant increase in regulatory B lymphocytes. We wondered how this approach affected the continued clinical course of these patients.Methods:Ten patients from a phase I clinical trial who had received MIC infusions prior to kidney transplantation were retrospectively compared to 15 matched standard-risk recipients. Follow-up was until year five after surgery.Results:The 10 MIC patients had an excellent clinical course with stable kidney graft function, no donor-specific human leukocyte antigen antibodies (DSA) or acute rejections, and no opportunistic infections. In comparison, a retrospectively matched control group receiving standard immunosuppressive therapy had a higher frequency of DSA (log rank P = 0.046) and more opportunistic infections (log rank P = 0.033). Importantly, MIC patients, and in particular the four patients who had received the highest cell number 7 days before surgery and received low immunosuppression during follow-up, continued to show a lack of anti-donor T lymphocyte reactivity in vitro and high CD19+CD24hiCD38hi transitional and CD19+CD24hiCD27+ memory B lymphocytes until year five after surgery.Conclusions:MIC infusions together with reduced conventional immunosuppression were associated with good graft function during five years of follow-up, no de novo DSA development and no opportunistic infections. In the future, MIC infusions might contribute to graft protection while reducing the side effects of immunosuppressive therapy. However, this approach needs further validation in direct comparison with prospective controls.Trial registration:https://clinicaltrials.gov/, identifier NCT02560220 (for the TOL-1 Study). EudraCT Number: 2014-002086-30.

Introduction Despite continued efforts, long-term outcomes of kidney transplantation remain unsatisfactory. Kidney graft rejections are independent risk factors for graft failure. At the participating centres of the TRAnsplant BIOpsies study group, a common therapeutic standard has previously been defined for the treatment of graft rejections. The outcomes of this strategy will be assessed in a prospective, observational cohort study. Methods and analysis A total of 800 kidney transplantation patients will be enrolled who undergo a graft biopsy because of deteriorating kidney function. Patients will be stratified according to the Banff classification, and the influence of the treatment strategy on end points will be assessed using regression analysis. Primary end points will be all-cause mortality and graft survival. Secondary end points will be worsening of kidney function (≥30% decline of estimated Glomerular Filtration Rate [eGFR] or new-onset large proteinuria), recurrence of graft rejection and treatment response. Baseline data and detailed histopathology data will be entered into an electronic database on enrolment. During a first follow-up period (within 14 days) and subsequent yearly follow-ups (for 5 years), treatment strategies and clinical course will be recorded. Recruitment at the four participating centres started in September 2016. As of August 2020, 495 patients have been included. Ethics and dissemination Ethical approval for the study has been obtained from the ethics committee of Kiel (AZ B 278/16) and was confirmed by the committees of Munich, Mainz and Stuttgart. The results will be reported in a peer-reviewed journal, according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. Trial registration number ISRCTN78772632; Pre-results.

BackgroundStandardized patients are widely used in training of medical students, both in teaching and assessment. They also frequently lead complete training sessions delivering physical examination skills without the aid of faculty teaching staff -acting as "patient instructors " (PIs). An important part of this training is their ability to provide detailed structured feedback to students which has a strong impact on their learning success. Yet, to date no study has assessed the quality of physical examination related feedback by PIs. Therefore, we conducted a randomized controlled study comparing feedback of PIs and faculty staff following a physical examination assessed by students and video assessors.Methods14 PIs and 14 different faculty staff physicians both delivered feedback to 40 medical students that had performed a physical examination on the respective PI while the physicians observed the performance. The physical examination was rated by two independent video assessors to provide an objective performance standard (gold standard). Feedback of PI and physicians was content analyzed by two different independent video assessors based on a provided checklist and compared to the performance standard. Feedback of PIs and physicians was also rated by medical students and video assessors using a questionnaire consisting of 12 items.ResultsThere was no statistical significant difference concerning overall matching of physician or PI feedback with gold standard ratings by video assessment (p =.219). There was also no statistical difference when focusing only on items that were classified as major key steps (p=.802), mistakes or parts that were left out during physical examination (p =.219) or mistakes in communication items (p=.517). The feedback of physicians was significantly better rated than PI feedback both by students (p=.043) as well as by video assessors (p=.034).ConclusionsIn summary, our study demonstrates that trained PIs are able to provide feedback of equal quantitative value to that of faculty staff physicians with regard to a physical examination performed on them. However, both the students and the video raters judged the quality of the feedback given by the physicians to be significantly better than that of the PIs.

Background Redundant training and feedback are crucial for successful acquisition of skills in simulation trainings. It is still unclear how or how much feedback should best be delivered to maximize its effect, and how learners’ activity and feedback are optimally blended. To determine the influence of high- versus low-frequency expert feedback on the learning curve of students’ clinical procedural skill acquisition in a prospective randomized study. Methods N = 47 medical students were trained to insert a nasogastric tube in a mannequin, including structured feedback in the initial instruction phase at the beginning of the training (T 1 ), and either additional repetitive feedback after each of their five subsequent repetitions (high-frequency feedback group, HFF group; N = 23) or additional feedback on just one occasion, after the fifth repetition only (low-frequency feedback group, LFF group; N = 24). We assessed a) task-specific clinical skill performance and b) global procedural performance (five items of the Integrated Procedural Performance Instrument (IPPI); on the basis of expert-rated videotapes at the beginning of the training (T 1 ) and during the final, sixth trial (T 2 ). Results The two study groups did not differ regarding their baseline data. The calculated ANOVA for task-specific clinical skill performance with the between-subject factor ‘Group’ (HFF vs. LFF) and within-subject factors ‘Time’ (T 1 vs. T 2 ) turned out not to be significant (p < .147). An exploratory post-hoc analyses revealed a trend towards a superior performance of HFF compared to LFF after the training (T 2 ; p < .093), whereas both groups did not differ at the beginning (T 1 ; p < .851). The smoothness of the procedure assessed as global procedural performance , was superior in HFF compared to LFF after the training (T 2 ; p < .004), whereas groups did not differ at the beginning (T 1 ; p < .941). Conclusion Deliberate practice with both high- and low-frequency intermittent feedback results in a strong improvement of students’ early procedural skill acquisition. High - frequency intermittent feedback, however, results in even better and smoother performance. We discuss the potential role of the cognitive workload on the results. We advocate a thoughtful allocation of tutor resources to future skills training.

BACKGROUND:The physical examination of patients is an important diagnostic competence, but little is known about the examination skills of final-year medical students. AIMS:To investigate physical examination skills of final-year medical students. METHODS:In a cross-sectional study, 40 final-year students were asked to perform a detailed physical examination on standardized patients. Their performances were video-recorded and rated by independent video assessors. RESULTS:Video ratings showed a mean success rate of 40.1 % (SD 8.2). As regards accompanying doctor-patient communication, final-year students achieved a mean of no more than 36.7 % (SD 8.9) in the appropriate use of the corresponding communication items. CONCLUSIONS:Our study revealed severe deficits among final-year medical students in performing a detailed physical examination on a standardized patient. Thus, physical examination skills training should aim to improve these deficits while also paying attention to communicative aspects.

Background: Physical clinical examination is a core clinical competence of medical doctors. In this regard, digital rectal examination (DRE) plays a central role in the detection of abnormalities of the anus and rectum. However, studies in undergraduate medical students as well as newly graduated doctors show that they are insufficiently prepared for performing DRE. Training units with Standardized Patients (SP) represent one method to deliver DRE skills. As yet, however, it is little known about SPs' attitudes.Methods: This is a qualitative study using a grounded theory approach. Interviews were conducted with 4 standardized patients about their experiences before, during and after structured SP training to deliver DRE competencies to medical students. The resulting data were subjected to thematic content analysis.Results: Results show that SPs do not have any predominant motives for DRE program participation. They participate in the SP training sessions with relatively little prejudice and do not anticipate feeling highly vulnerable within teaching sessions with undergraduate medical students.Conclusions: The current study examined SPs' motives, views, expectations and experiences regarding a DRE program during their first SP training experiences. The results enabled us to derive distinct action guidelines for the recruitment, informing and briefing of SPs who are willing to participate in a DRE program.

Background: Although Peyton's four-step approach is a widely used method for skills-lab training in undergraduate medical education and has been shown to be more effective than standard instruction, it is unclear whether its superiority can be attributed to a specific single step. Purpose: We conducted a randomized controlled trial to investigate the differential learning outcomes of the separate steps of Peyton's four-step approach. Methods: Volunteer medical students were randomly assigned to four different groups. Step-1 group received Peyton's Step 1, Step-2 group received Peyton's Steps 1 and 2, Step-3 group received Peyton's Steps 1, 2, and 3, and Step-3mod group received Peyton's Steps 1 and 2, followed by a repetition of Step 2. Following the training, the first independent performance of a central venous catheter (CVC) insertion using a manikin was video-recorded and scored by independent video assessors using binary checklists. The day after the training, memory performance during delayed recall was assessed with an incidental free recall test. Results: A total of 97 participants agreed to participate in the trial. There were no statistically significant group differences with regard to age, sex, completed education in a medical profession, completed medical clerkships, preliminary memory tests, or self-efficacy ratings. Regarding checklist ratings, Step-2 group showed a superior first independent performance of CVC placement compared to Step-1 group (P,0.001), and Step-3 group showed a superior performance to Step-2 group (P,0.009), while Step-2 group and Step-3mod group did not differ (P=0.055). The findings were similar in the incidental free recall test. Conclusion: Our study identified Peyton's Step 3 as being the most crucial part within Peyton's four-step approach, contributing significantly more to learning success than the previous steps and reaching beyond the benefit of a mere repetition of skills demonstration.

Background: Skills-lab training as a methodological teaching approach is nowadays part of the training programs of almost all medical faculties. Specific ingredients have been shown to contribute to a successful learning experience in skills-labs. Although it is undoubted that the instructional approach used to introduce novel clinical technical skills to learners has a decisive impact on subsequent skills performance, as yet, little is known about differential effects of varying instructional methods. An instructional approach that is becoming increasingly prevalent in medical education is "Peyton's Four-Step Approach". As Peyton's Four Step Approach was designed for a 1:1 teacher : student ratio, the aim of the present study was to develop and evaluate a modified Peyton's Approach for small group teaching.Methods: The modified Peyton's Approach was applied in three skills-lab training sessions on IV catheter insertion, each with three first-or second year medical students (n = 9), delivered by three different skills-lab teachers. The presented descriptive study investigated the practicability and subjective impressions of skills-lab trainees and tutors. Skills-lab sessions were evaluated by trainees' self-assessment, expert ratings, and qualitative analysis of semi-standardized interviews conducted with trainees and tutors.Results: The model was well accepted by trainees, and was rated as easy to realize, resulting in a good flow of teaching and success in attracting trainee's attention when observed by expert raters. Qualitative semi- standardized interviews performed with all of the trainees and tutors revealed that trainees valued repeated observation, instruction of trainees and the opportunity for independent performance, while tutors stressed that trainees were highly concentrated throughout the training and that they perceived repeated observation to be a valuable preparation for their own performance.Conclusion: The modified Peyton's Approach to instruct small groups of students in skills-lab training sessions has revealed to be practicable, well accepted by trainees, and easy for tutors to realize. Further research should address the realization of the model in larger skills-lab training groups.

Background Skills lab training has become a widespread tool in medical education, and nowadays, skills labs are ubiquitous among medical faculties across the world. An increasingly prevalent didactic approach in skills lab teaching is peer-assisted learning (PAL), which has been shown to be not only effective, but can be considered to be on a par with faculty staff-led training. The aim of the study is to determine whether voluntary preclinical skills teaching by peer tutors is a feasible method for preparing medical students for effective workplace learning in clerkships and to investigate both tutees’ and tutors’ attitudes towards such an intervention. Methods A voluntary clerkship preparation skills course was designed and delivered. N = 135 pre-clinical medical students visited the training sessions. N = 10 tutors were trained as skills-lab peer tutors. Voluntary clerkship preparation skills courses as well as tutor training were evaluated by acceptance ratings and pre-post self-assessment ratings. Furthermore, qualitative analyses of skills lab tutors’ attitudes towards the course were conducted following principles of grounded theory. Results Results show that a voluntary clerkship preparation skills course is in high demand, is highly accepted and leads to significant changes in self-assessment ratings. Regarding qualitative analysis of tutor statements, clerkship preparation skills courses were considered to be a helpful and necessary asset to preclinical medical education, which benefits from the tutors’ own clerkship experiences and a high standardization of training. Tutor training is also highly accepted and regarded as an indispensable tool for peer tutors. Conclusions Our study shows that the demand for voluntary competence-oriented clerkship preparation is high, and a peer tutor-led skills course as well as tutor training is well accepted. The focused didactic approach for tutor training is perceived to be effective in preparing tutors for their teaching activity in this context. A prospective study design would be needed to substantiate the results objectively and confirm the effectiveness.

Background: Ward rounds represent an important task in clinical settings. Despite their importance, students show substantial deficits in ward round competencies (e. g. physical examination, drug prescription, documentation). Previously reported teaching methods such as ward round training with standardized patients or educational wards, however, are time-consuming and expensive.Aims: To assess the effects of a structured on-ward supervision program for final-year students with specially trained supervising doctors focusing on ward round competencies.Method: A total of 36 medical students were randomly assigned to an intervention group (IG) and a control group (CG). During an eight-week-long training course, the intervention group (IG; n = 18) received structured ward round training while the control group (CG; n = 18) received on-ward training regarding how to take patient histories and perform physical examinations. Ward round competencies were assessed using simulated ward round scenarios with objective checklist ratings and standardized patient ratings.Results: The IG achieved significantly more predefined learning goals compared to the CG. Standardized patient ratings did not differ significantly between groups.Conclusions: Results provide evidence that the presented program is a feasible and efficient tool for teaching ward round skills at the bedside. Further research should focus on cost effectiveness compared to alternative models.

BACKGROUND:Learning on the ward as a practice-oriented preparation for the future workplace plays a crucial role in the medical education of future physicians. However, students' ward internship is partially problematic due to condensed workflows on the ward and the high workload of supervising physicians. For the first time in a German-speaking setting, students' expectations and concerns about their internship on the ward are examined in a qualitative analysis regarding their internal medicine rotation within clinical medical education.METHODS:Of a total of 168 medical students in their 6th semester at the Medical Faculty of Heidelberg, 28 students (m=8, f=20, Ø 23.6 years) took part in focus group interviews 3 to 5 days prior to their internship on the internal medicine ward within their clinical internal medicine rotation. Students were divided into four different focus groups. The protocols were transcribed and a content analysis was conducted based on grounded theory.RESULTS:We gathered a total of 489 relevant individual statements. The students hope for a successful integration within the ward team, reliable and supportive supervisors and supervision in small groups. They expect to face the most common diseases, to train the most important medical skills, to assume full responsibility for their own patients and to acquire their own medical identity. The students fear an insufficient time frame to achieve their aims. They are also concerned they will have too little contact with patients and inadequate supervision.CONCLUSION:For the development and standardization of effective student internships, the greatest relevance should be attributed to guidance and supervision by professionally trained and well-prepared medical teachers, entailing a significant increase in staff and costs. A structural framework is required in order to transfer the responsibility for the treatment of patients to the students at an early stage in medical education and in a longitudinal manner. The data suggest that the development and establishment of guidelines for medical teachers associated with clearly defined learning objectives for the students' internships are urgently needed. Based on our findings, we provide first recommendations and suggest possible solutions.

BACKGROUND:Peer-assisted learning (PAL) has become a well-accepted teaching method within medical education. However, descriptions of on-ward PAL programs are rare. A focus group analysis of a newly established PAL program on an internal medicine ward was conducted to provide insights into PAL teaching from a student perspective.PURPOSE:To provide insights into students' experiences regarding their on-ward training with and without accompanying PAL tutors.METHODS:A total of N=168 medical students in their sixth semester participated in the investigation (intervention group: N=88; control group: N=80). The intervention group took part in the PAL program, while the control group received standard on-ward training. There were seven focus groups with N=43 participants (intervention group: four focus groups, N=28 participants; control group: three focus groups, N=15 participants). The discussions were analyzed using content analysis.RESULTS:The intervention group emphasized the role of the tutors as competent and well-trained teachers, most beneficial in supervising clinical skills. Tutors motivate students, help them to integrate into the ward team, and provide a non-fear-based working relationship whereby students' anxiety regarding working on ward decreases. The control group had to rely on autodidactic learning strategies when neither supervising physicians nor final-year students were available.CONCLUSION:On-ward PAL programs represent a particularly valuable tool for students' support in training clinical competencies on ward. The tutor-student working alliance acts through its flat hierarchy. Nevertheless, tutors cannot represent an adequate substitute for experienced physicians.

[english] Background: Learning on the ward as a practice-oriented preparation for the future workplace plays a crucial role in the medical education of future physicians. However, students’ ward internship is partially problematic due to condensed workflows on the ward and the high workload of supervising physicians. For the first time in a German-speaking setting, students’ expectations and concerns about their internship on the ward are examined in a qualitative analysis regarding their internal medicine rotation within clinical medical education.Methods: Of a total of 168 medical students in their 6th semester at the Medical Faculty of Heidelberg, 28 students (m=8, f=20, Ø 23.6 years) took part in focus group interviews 3 to 5 days prior to their internship on the internal medicine ward within their clinical internal medicine rotation. Students were divided into four different focus groups. The protocols were transcribed and a content analysis was conducted based on grounded theory.Results: We gathered a total of 489 relevant individual statements. The students hope for a successful integration within the ward team, reliable and supportive supervisors and supervision in small groups. They expect to face the most common diseases, to train the most important medical skills, to assume full responsibility for their own patients and to acquire their own medical identity. The students fear an insufficient time frame to achieve their aims. They are also concerned they will have too little contact with patients and inadequate supervision.Conclusion: For the development and standardization of effective student internships, the greatest relevance should be attributed to guidance and supervision by professionally trained and well-prepared medical teachers, entailing a significant increase in staff and costs. A structural framework is required in order to transfer the responsibility for the treatment of patients to the students at an early stage in medical education and in a longitudinal manner. The data suggest that the development and establishment of guidelines for medical teachers associated with clearly defined learning objectives for the students’ internships are urgently needed. Based on our findings, we provide first recommendations and suggest possible solutions.