BackgroundOne of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning.MethodsPATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals.A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative.DiscussionPATRONUS will provide essential insights into the patients’ assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research.Trial registrationGerman Clinical Trials Register: DRKS00013035 (registered on October 26, 2017).Universal Trial Number (UTN): U1111–1202-8863.Electronic supplementary materialThe online version of this article (10.1186/s12893-018-0422-3) contains supplementary material, which is available to authorized users.

Background Ileus is common after elective colorectal surgery, and is associated with increased adverse events and prolonged hospital stay. The aim was to assess the role of non‐steroidal anti‐inflammatory drugs (NSAIDs) for reducing ileus after surgery. Methods A prospective multicentre cohort study was delivered by an international, student‐ and trainee‐led collaborative group. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The primary outcome was time to gastrointestinal recovery, measured using a composite measure of bowel function and tolerance to oral intake. The impact of NSAIDs was explored using Cox regression analyses, including the results of a centre‐specific survey of compliance to enhanced recovery principles. Secondary safety outcomes included anastomotic leak rate and acute kidney injury. Results A total of 4164 patients were included, with a median age of 68 (i.q.r. 57–75) years (54·9 per cent men). Some 1153 (27·7 per cent) received NSAIDs on postoperative days 1–3, of whom 1061 (92·0 per cent) received non‐selective cyclo‐oxygenase inhibitors. After adjustment for baseline differences, the mean time to gastrointestinal recovery did not differ significantly between patients who received NSAIDs and those who did not (4·6 versus 4·8 days; hazard ratio 1·04, 95 per cent c.i. 0·96 to 1·12; P = 0·360). There were no significant differences in anastomotic leak rate (5·4 versus 4·6 per cent; P = 0·349) or acute kidney injury (14·3 versus 13·8 per cent; P = 0·666) between the groups. Significantly fewer patients receiving NSAIDs required strong opioid analgesia (35·3 versus 56·7 per cent; P < 0·001). Conclusion NSAIDs did not reduce the time for gastrointestinal recovery after colorectal surgery, but they were safe and associated with reduced postoperative opioid requirement.

Zusammenfassung Hintergrund Die Vermittlung wissenschaftlicher Kompetenzen im Medizinstudium ist mangelhaft. Dies setzt sich in der Weiterbildung fort und führt zunehmend zu einem Mangel an wissenschaftlich tätigen Ärzten. Das chirurgische Studiennetzwerk (CHIR-Net) hat ein studentisches Forschungsnetzwerk gegründet (SIGMA, Student-initiated German Medical Audit), um dem entgegenzuwirken. Ziel dieser Arbeit ist es, die Entwicklung, Umsetzung und Evaluation eines Prüf-Studierenden-Kurses (PSK) zu beschreiben, der Studierende zur eigenständigen Durchführung von klinischen Studien befähigen soll. Material und Methoden Anhand des Kernzyklus wurde ein 3-gliedriges Curriculum entwickelt, das aus Onlinetutorien, einer Wochenendpräsenzphase sowie einer Nachbereitungsperiode besteht. Die Lernziele wurden anhand der Bloom-Taxonomie des Wissens definiert. Die Lehrinhalte richteten sich nach Vorgaben der Koordinierungszentren für Klinische Studien (KKS-Netzwerk) und der Bundesärztekammer für ärztliche Prüferkurse sowie studienrelevanten Inhalten. Eine große Bandbreite an verschiedenen Lehrmethoden sowie Prüfungsformaten wurde eingesetzt. Durch Einbindung studienrelevanter Berufsgruppen wurde eine enge Verzahnung mit den Studierenden gewährleistet. Der Wissenszuwachs wurde anhand eines Multiple-Choice-Prä-Post-Tests evaluiert. Die Evaluation der Zufriedenheit der Studierenden erfolgte mittels einer 5-Punkte-Likert-Skala, wobei 5 eine volle Zustimmung markierte. Ergebnisse Der erste SIGMA-PSK wurde im Frühjahr 2018 erfolgreich implementiert. Die Präsenzphase fand im Februar 2018 mit 32 Studierenden aus 13 Standorten statt, wobei die Studierenden aus unterschiedlichen Semestern kamen. Im Mittel wurden im Prä-Test 53,8 ± 8,3% der Fragen korrekt beantwortet vs. 71,2 ± 7,2% im Post-Test (p < 0,0001). Die größte individuelle Verbesserung des Testergebnisses betrug 30%, die geringste Differenz zum Prä-Test 5%. Subjektive Evaluationsergebnisse des Kurses waren durchweg positiv mit einem durchschnittlichen Ergebnis von 4,63 ± 0,34 auf der 5-Punkte-Likert-Skala. Schlussfolgerung Eine Ausbildung von Medizinstudierenden in den Grundlagen klinischer Studien ist machbar. Ein kompakter PSK kann unter dem Einsatz moderner Lehrdidaktik die Studierenden auf die eigenständige Durchführung klinischer Studien vorbereiten.

Evidence should define and guide modern clinical care, yet many relevant questions in surgical practice remain unconfirmed by substantial data. Evidence-based medicine requires both the implementation of its principles in day-to-day work and the acquisition of new evidence preferably by randomized controlled trials and systematic reviews. Meaningful clinical research, however, is challenging to conduct, and its overall infrastructure in Germany was, until recently, considered poor compared to other leading countries. Although this has been significantly improved after the establishment of the Study Center of the German Surgical Society (SDGC) and the surgical clinical trial network CHIR-Net, limited focus has been put on the training, teaching, and recruitment of medical students to become competent clinical researchers and clinician scientists. To ensure continuing comprehensive clinical research in surgery, CHIR-Net aims to establish a student-driven multicenter research network in Germany, which is embedded in both the national CHIR-Net and the pan-European and international frameworks. Student-Initiated German Medical Audits (SIGMA) is a product of the strong collaboration between clinical scientists and medical trainees, enabling students to contribute to high-quality clinical trials.Additionally, participants are offered extensive training to support the next generation of research-active clinicians. Starting on 2018, SIGMA will perform its first multicenter observational study in Germany.

Background Most data on COVID-19 was collected in hospitalized cases. Much less is known about the spectrum of disease in entire populations. In this study, we examine a representative cohort of primarily symptomatic cases in an administrative district in Southern Germany. Methods We contacted all confirmed SARS-CoV-2 cases in the administrative district. Consenting participants answered a retrospective survey either via a telephone, electronically or via mail. Clinical and sociodemographic features were compared between hospitalized and non-hospitalized patients. Additionally, we assessed potential risk factors for hospitalization and time to hospitalization in a series of regression models. Results We included 897 participants in our study, 69% out of 1,305 total cases in the district with a mean age of 47 years (range 2–97), 51% of which were female and 47% had a pre-existing illness. The percentage of asymptomatic, mild, moderate (leading to hospital admission) and critical illness (requiring mechanical ventilation) was 54 patients (6%), 713 (79%), 97 (11%) and 16 (2%), respectively. Seventeen patients (2%) died. The most prevalent symptoms were fatigue (65%), cough (62%) and dysgeusia (60%). The risk factors for hospitalization included older age (OR 1.05 per year increase; 95% CI 1.04–1.07) preexisting lung conditions (OR 3.09; 95% CI 1.62–5.88). Female sex was a protective factor (OR 0.51; 95% CI 0.33–0.77). Conclusion This representative analysis of primarily symptomatic COVID-19 cases confirms age, male sex and preexisting lung conditions but not cardiovascular disease as risk factors for severe illness. Almost 80% of infection take a mild course, whereas 13% of patients suffer moderate to severe illness. Trial registration German Clinical Trials Register, DRKS00022926. URL: https://www.drks.de/drks_web/setLocale_EN.do