The PRECIS-2 tool has good interrater reliability and reasonable discriminant validity

This work was supported by the Chief Scientist Office (CSO) of Scotland grant CZH/4/773, the UK Medical Research Council and the University of Dundee work through the provision of a stipend for KL and from the Health Services Research Unit at the University of Aberdeen, which is core funded by the CSO of the Scottish Government Health Directories. We are grateful to all the participants who assisted in this study: F Althabe, A-W Chan, D Altman, D Bratton, E Brass, M Campbell, G Forbes, B Gaglio, R Glasgow, H Hobbelen, S Hopewell, J Krishnan, D Riddle, J Segal, D Steinfort, P Tugwell, SN Van der Veer, VA. Welch, C Witt.Peer reviewedPostprin

Stress experiences of healthcare assistants in family practice at the onset of the COVID-19 pandemic: a mixed methods study

BackgroundAt the beginning of the pandemic in 2020, healthcare assistants in general practices were confronted with numerous new challenges. The aim of the study was to investigate the stress factors of healthcare assistants in March/April 2020 as well as in the further course of the pandemic in 2020.MethodsFrom August to December 2020, 6,300 randomly selected healthcare assistants in four German states were invited to participate in the study. We performed a mixed methods design using semi-structured telephone interviews and a cross-sectional survey with quantitative and open questions. The feeling of psychological burden was assessed on a 6-point likert-scale. We defined stress factors and categorized them in patient, non-patient and organizational stress factors. The results of the three data sets were compared within a triangulation protocol.ResultsOne thousand two hundred seventy-four surveys were analyzed and 28 interviews with 34 healthcare assistants were conducted. Of the participants, 29.5% reported experiences of a very high or high feeling of psychological burden in March/April 2020. Worries about the patients’ health and an uncertainty around the new disease were among the patient-related stress factors. Non-patient-related stress factors were problems with the compatibility of work and family, and the fear of infecting relatives with COVID-19. Organizational efforts and dissatisfaction with governmental pandemic management were reported as organizational stress factors. Support from the employer and team cohesion were considered as important resources.DiscussionIt is necessary to reduce stress among healthcare assistants by improving their working conditions and to strengthen their resilience to ensure primary healthcare delivery in future health crises

Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices

<p>Abstract</p> <p>Background</p> <p>Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices.</p> <p>Methods</p> <p>This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety.</p> <p>Results</p> <p>The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial.</p> <p>Conclusions</p> <p>To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care.</p> <p>Trial Registration</p> <p>Trial registration number: <a href="http://www.controlled-trials.com/ISRCTN00470468">ISRCTN00470468</a></p

Decision aid for patients

Die REGATTA Studie untersuchte die Wirksamkeit des pflanzlichen Mittels Bärentraubenblätterextrakt im Vergleich mit dem Antibiotikum Fosfomycin bei Frauen mit einem unkomplizierten Harnwegsinfekt. In diesem Flyer stellen wir Ihnen die wesentlichen Ergebnisse der Studie zusammenfassend dar.1

Überbringen schwerwiegender Nachrichten – ein interdisziplinäres Lehrkonzept im Pflichtcurriculum [Breaking bad news – an interdisciplinary curricular teaching-concept]

[english] Background: The concerns of patients suffering from life-threatening disease and end-of-life care aspects have gained increasing attention in public perception. The increasing focus on palliative medicine questions can be considered to be paradigmatic for this development. Palliative medicine became a compulsory subject of the undergraduate curriculum in Germany to be implemented until 2013. The preexisting conditions and qualifications at the medical faculties vary, though. We describe the conceptual process, didactic background, and first experiences with the new interdisciplinary course “Delivering bad news” as a compulsory part of the palliative medicine curriculum. Methods: Since autumn 2009, this course has been taught at the University Medical Center Göttingen, consisting of two double lessons in the final year of medical education. Considering the curriculum-based learning goals in Göttingen, the focus of this course is to impart knowledge, attitudes and communication skills relating to “bad news”. Results: Although the seminar requires adequate staff and is time-consuming, students have accepted it and gave high marks in evaluations. In particular, the teachers’ performance and commitment was evaluated positively.Discussion and Conclusions: We describe the first experiences with a new course. Didactic structure, theoretical contents, role-plays and usage of media (film, novel) are well- suited to communicate topics such as “bad news”. Additional experiences and evaluations are necessary. According to the progressive nature of learning, it might be worthwhile to repeat communication- centered questions several times during medical studies.<br>[german] Zielsetzung: Verschiedene Aspekte bei der Behandlung lebensbedrohlich erkrankter Patienten und der Begleitung Sterbender rücken zunehmend in den gesellschaftlichen Fokus. Paradigmatisch hierfür kann die zunehmende Aufmerksamkeit gegenüber palliativmedizinischen Inhalten betrachtet werden, die seit der letzten Änderung der ärztlichen Approbationsordnung im Medizinstudium ab 2013 verpflichtend unterrichtet und geprüft werden müssen. Die didaktischen Vorerfahrungen und strukturellen Voraussetzungen zur Integration von Lebensend-Themen in das studentische Curriculum sind an den einzelnen Fakultäten jedoch sehr unterschiedlich. Dieser Artikel beschreibt die Konzeption des neuen Pflichtseminars „Überbringen schlechter Nachrichten“, dessen didaktischen Hintergrund sowie erste Erfahrungen bei der Durchführung für Studierende unmittelbar vor Eintritt in das Praktische JahrMethodik: An der Universitätsmedizin Göttingen wird seit dem Wintersemester 2009 ein aus zwei Doppelstunden bestehendes Pflicht-Seminar zum Thema „Überbringen schwerwiegender Nachrichten“ unterrichtet. Unter Berücksichtigung des Göttinger Lernzielkataloges wird Wissen vermittelt, die kommunikativen Fertigkeiten in Form von Rollenspielen verbessert und die affektive Ebene durch den Einsatz von Literatur mit einbezogen. Ergebnisse und Schlussfolgerung: Das Seminar ist zwar zeit- und personalaufwendig, wird aber von den Studierenden gut angenommen und evaluiert. Besonders positiv wird das Auftreten der Dozenten bewertet. Der didaktische Aufbau von Lerninhalten durch Kombination von Medien (Filmausschnitt, Roman), Kleingruppenarbeit und Rollenspielen ist zur Vermittlung des Themas gut geeignet. Weitere Evaluationen müssen folgen. Wünschenswert wäre im Sinne der Lernspirale ein mehrfaches Aufgreifen des Themas innerhalb des Studiums

Resistance profiles of urinary tract infections in general practice - an observational study

Abstract Background Guideline recommendations on therapy in urinary tract infections are based on antibiotic resistance rates. Due to a lack of surveillance data, little is known about resistance rates in uncomplicated urinary tract infection (UTI) in general practice in Germany. In a prospective observational study, urine cultures of all women presenting with urinary tract infections in general practice were analysed. Resistance rates against antibiotics recommended in German guidelines on UTI are presented. Methods In a prospective, multi-center observational study general practitioner included all female patients ≥ 18 years with clinically suspected urinary tract infection. Only patients receiving an antibiotic therapy within the last two weeks were excluded. Results 40 practices recruited 191 female patients (mean age 52 years; range 18–96) with urinary tract infections. Main causative agent was Escherichia coli (79%) followed by Enterococcus faecalis (14%) and Klebsiella pneumoniae (7.3%). Susceptibiliy of E.coli as the main causative agent was highest against fosfomycin and nitrofurantoin, with low resistance rates of 4,5%; 2,2%. In 17,5%, E.coli was resistant to trimethoprim and in 8,5% to ciprofloxacin. Conclusions Resistance rates of uropathogens from unselected patients in general practice differ from routinely collected laboratory data. These results can have an impact on antibiotic prescribing and treatment recommendations.</p