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BackgroundPatient safety is a priority worldwide. When things go wrong in the provision of patient care, the healthcare professionals involved can be psychologically affected (second victims, SVs). Recently, different initiatives have been launched to address this phenomenon.AimTo identify through the ERNST Pan-European Consortium the current study lines in Europe on SVs and other topics related to how the lack of well-being of healthcare professionals can affect the quality of care.MethodsA cross-sectional study was conducted based on an ad hoc online survey. All 82 academics and clinicians who had formalized their membership to the COST Action 19113 by September 2020 and represented 27 European and one neighboring country were invited to participate. The survey consisted of 19 questions that explored the participants’ scientific profile, their interests, and previous experiences in the SVs’ topic, and related areas of work in Europe.ResultsSeventy (85.4%) COST Action members responded to the survey. Thirty-seven (37.1%) had conducted SV studies in the past or were doing so at the moment of the survey. Seventeen participants were involved in implementing interventions to support SVs. Future lines of study included legal issues, open disclosure, training programs, and patient safety curricula.ConclusionsStudies have been conducted in Europe on the magnitude of the SV phenomenon and the usefulness of some techniques to promote resilience among healthcare professionals. New gaps have been identified. The COST Action 19113 aims to foster European collaboration to reinforce the healthcare professionals’ well-being and thus contribute to patient safety.

An editorial is presented on the mitigating the July effect. Topics include the arrival of a crop of newly graduated medical students beginning their internships, the influx of so many freshly trained physicians arriving at the same time always triggers concern, and the belief in a July effect with presumed adverse consequences for patient safety and quality of care.

ZusammenfassungDer Begriff Second Victim beschreibt eine an der Patientenversorgung beteiligte Person, die durch eine außergewöhnliche Situation in der Patientenversorgung selbst traumatisiert wird. Dieses in der Öffentlichkeit noch weitgehend unbekannte, aber weit verbreitete Phänomen wird durch die COVID-19-Pandemie verschärft und birgt das Risiko, durch eine ausgeprägte psychische Überlastung der Behandelnden Gesundheitssysteme zusätzlich unter Druck zu setzen. Dies stellt sowohl für die Patienten als auch für die Mitarbeitersicherheit eine ernstzunehmende Gefahr dar. Das Second-Victim-Phänomen ist gut erforscht und bedarf einer zweigleisigen Strategie. Einerseits müssen Second Victims in einem flächendeckenden, möglichst niederschwellig erreichbaren gestuften System schnell, persönlich und vertraulich unterstützt werden. Andererseits kommt der Stärkung der Resilienz aller Behandelnden besondere Bedeutung zu. Die Resilienz und damit die langfristige Leistungsfähigkeit der Behandelnden kann durch eine besondere Berücksichtigung im Führungsverhalten und in der Krisenkommunikation nachhaltig unterstützt werden. Sie leistet somit sowohl kurzfristig als auch nachhaltig einen positiven Beitrag für die Patientensicherheit und damit die Überlebenschancen vieler Patienten während und nach der COVID-19-Pandemie.

Zusammenfassung Einleitung Second Victims, definiert als medizinische Fachpersonen, die durch einen unvorhergesehenen klinischen Zwischenfall traumatisiert werden, sind ein verbreitetes Phänomen im Gesundheitswesen. Studien aus den USA zeigen hohe Inzidenzen zwischen 10 und 42 % bei medizinischem Personal. Allerdings existiert kein validierter deutscher Fragebogen, der sich mit der Inzidenz und den Auswirkungen auseinandersetzt. Deshalb wurde im Rahmen des SeViD-Projekts (Second Victims im Deutschsprachigen Raum) ein deutschsprachiger Fragebogen zur Beurteilung von Second-Victim-Erfahrungen entwickelt. Methoden Basierend auf einer Literaturrecherche nach existierenden Fragebögen in englischer Sprache wurde eine vorläufige Version des Fragebogens bestehend aus 4 Bereichen und 14 Fragen erstellt. Diese wurde kognitiven Pretests unterzogen, um die Inhaltsvalidität zu überprüfen. Ergebnisse Fünfzehn medizinische Fachpersonen aus Krankenhäusern in Deutschland (n = 6) und Österreich (n = 9) nahmen nach Einverständniserklärung als Freiwillige an allen Pretests teil. Sieben Fragen in 3 Bereichen wurden basierend auf kognitiven Pretests leicht modifiziert. Die durchschnittliche Bearbeitungszeit des Fragebogens betrug 9:01 (±3:05) min im Fall einer vorherigen Second-Victim-Erfahrung und 4:19 (±0:59) min ohne entsprechendes Erlebnis. Die Befragung wurde von allen Freiwilligen als angemessen bewertet. Schlussfolgerung Es konnte ein inhaltsvalidierter Fragebogen entwickelt werden, der die Auswirkung des Second-Victim-Phänomens in stationären Gesundheitseinrichtungen im deutschsprachigen Raum beurteilen kann. Dieser Fragebogen soll in verschiedenen Settings für medizinisches Fachpersonal sowohl für Erhebungen des Status quo als auch für Verlaufsbeobachtungen in Interventionsstudien eingesetzt werden.

Background: The second victim phenomenon is common among nurses in intensive care units. Apart from quantitative studies, little is known about individual cases among those high-risk groups. This study evaluates the natural history and cause of second victim traumatization in Western Austria for the first time to tailor specific intervention. Methods: A total of 20 guided interviews were conducted with intensive care nurses in Western Austria. All interviews were transcribed and analyzed with MAXQDA software. Evaluation followed the structuring qualitative content analysis scheme according to Kuckartz. Results: The most frequent symptoms of the second victim phenomenon reported were feelings of guilt and problems with falling asleep. Coping with the second victim phenomenon was accomplished by conversations in private as well as among work colleagues. Conclusions: Intensive care nurses are exposed to many exceptional situations which have a high likelihood of resulting in second victim traumatization. As proximal psychosocial support is considered to be a main source of coping, wide-spread implementation of effective psychosocial peer support programs ought to be applied by medical organizations. Patient safety measures such as proactive and reactive clinical risk management (e.g., CIRS) should be linked to second victim support.

The concept of second victims (SV) was introduced 20 years ago to draw attention to healthcare professionals involved in patient safety incidents. The objective of this paper is to advance the theoretical conceptualization and to develop a common definition. A literature search was performed in Medline, EMBASE and CINAHL (October 2010 to November 2020). The description of SV was extracted regarding three concepts: (1) involved persons, (2) content of action and (3) impact. Based on these concepts, a definition was proposed and discussed within the ERNST-COST consortium in 2021 and 2022. An international group of experts finalized the definition. In total, 83 publications were reviewed. Based on expert consensus, a second victim was defined as: "Any health care worker, directly or indirectly involved in an unanticipated adverse patient event, unintentional healthcare error, or patient injury and who becomes victimized in the sense that they are also negatively impacted". The proposed definition can be used to help to reduce the impact of incidents on both healthcare professionals and organizations, thereby indirectly improve healthcare quality, patient safety, person-centeredness and human resource management. ispartof: International Journal Of Environmental Research And Public Health vol:19 issue:24 ispartof: location:Switzerland status: Published online

Ein unverzichtbarer Ratgeber für alle, die sich im Studium oder in der Arbeit mit dem Gesundheitssystem und der Medizin beschäftigen. Reinhard Strametz stellt medizinisches Grundwissen fundiert und leicht verständlich vor und führt kundig in Fachtermini ein. In den Mittelpunkt stellt er u.a. den Ablauf des medizinischen Behandlungsprozesses von der Anamnese bis zur Therapie sowie wichtige Methoden und Ansätze der Medizin, etwa die Evidenzbasierte Medizin und die Prävention. Auf Krankheitsbilder wie etwa Adipositas, Diabetes mellitus, Schlaganfall und Krebs geht er ebenso ein wie auf Pandemien und das Coronavirus SARS-CoV-2 (Covid-19). Auch Spannungsfelder der Medizin, die sich aus der Ökonomisierung und Digitalisierung ergeben, finden Beachtung. Die 5. Auflage wurde überarbeitet und in den Bereichen Diabetes, Covid-19 und Regelungen zum assistierten Suizid überarbeitet und erweitert.

Background: Second victim phenomena (SVP) are critical to workplace and patient safety, and epidemiological data are limited to investigate the causes and impact on German health care. We investigated SVP in German nurses regarding prevalence, causes, and predisposition compared to a preceding study on German physicians (Second Victims in Deutschland/SeViD-I). Methods: We conducted a nationwide anonymous cross-sectional online study in 2020 using a modified SeViD questionnaire including the BFI-10 (personality traits). Statistical analysis was conducted using chi² tests and binary logistic regression models. Results: Of 332 nurses, 60% reported to experience SVP at least once a working lifetime, with a 12-month prevalence among SVP of 49%. Of the nurses, 24% reported recovery times of more than 1 year. In contrast to physicians from SeViD-I, a main cause for becoming a second victim was aggressive behavior by patients. High neuroticism values, higher age, and medium work life experience, but neither gender nor workplace position, were predisposing for SVP. Like SeViD-I, nurses reported demand for an institutional response in cases of SVP. Conclusions: SVP is common among German nurses and comprises other causes and a different course than in physicians. Further research should concentrate on specific prevention strategies, e.g., profession- and workplace-based educational programs.

Introduction The second victim phenomenon that occurs after critical events poses a serious factor for patient and workplace safety. These experiences can be evaluated using the Second Victim Experience and Support Tool (SVEST), originally in English, or the translated and validated Korean or Chinese versions. In 2020, a revised version was published (SVESTR) with the addition of resilience items. The aim of this study is the validation of the German version, the G-SVESTR, in a multiprofessional setting. Methods The G-SVESTR questionnaire was designed according to World Health Organization recommendations. This entails translation, test for face validity, back translation, pretest, expert panel evaluation, and a test in a large population for validity and reliability. We provided an anonymous online questionnaire to physicians, nurses, paramedics, medical assistants, and physician assistants to test our developed tool. Statistics were accomplished using XL-Stats. Results Altogether, 72% (306 of 428) of the participants completed the survey. The mean time for completion was 9.4 minutes. Physician assistants and medical assistants were significantly younger than other respondents. The analysis revealed satisfactory reliability (Cronbach α = 0.844). A principal component analysis showed 11 factors with eigenvalues greater than 1. Factor loading on distinct dimensions was satisfactory with one exception, the absenteeism item (item 31), which showed cross-loadings and poor factor loading on the absenteeism dimension. The results of the G-SVESTR revealed only some differences between the professional subgroups. Conclusion The G-SVESTR is a valid and reliable testing instrument for the evaluation of second victim experiences in different medical professions.

Seit 2013 ist im Bachelor-Studiengang Gesundheitsokonomie der Hochschule RheinMain ein verpflichtendes Krankenpflegepraktikum von 2 Monaten Dauer vorgesehen. Dies stellt eine gefahrengeneigte Tatigkeit mit Risiken fur Patienten und Studierende dar. Daher wurde eine Risikobeurteilung durchgefuhrt, um durch geeignete Masnahmen diese Risiken zu minimieren und andernfalls entstehende Haftungsrisiken fur die Hochschule zu berucksichtigen. Mittels Szenario-Analyse nach ONR 49002-2 wurden die wesentlichen Risiken fur die Patienten- und Mitarbeitersicherheit unter Annahme des „credible worst case“ beurteilt. Auf Basis dieser Analyse wurden Praventionsmasnahmen vor Beginn der Entsendung der ersten Kohorte in ein Pflegepraktikum abgeleitet, umgesetzt und Masnahmen zur Uberprufung der Wirksamkeit festgelegt. Funf Risiken wurden als relevant und als in dieser bisherigen Auspragung ohne weitere Intervention nicht tragbar angesehen: nosokomiale Infektionen, Verzogerung einer Notfallbehandlung, Nadelstichverletzungen (NSV), mangelhafte Beachtung bzw. Umsetzung von Brandschutzmasnahmen und fehlerhafte Handlungen im Brandfall sowie Ubernahme uberfordernder, unbeaufsichtigt durchgefuhrter Tatigkeiten. Basierend auf der Risikoanalyse wurden eine arbeitsmedizinische Vorsorge, eine Kurzzeitlehrintervention vor Aufnahme der praktischen Tatigkeit und eine schriftliche Belehrung etabliert. Durch die praventive, systematische Risikobeurteilung konnten die wesentlichen Risiken durch anerkannte Praventionsmasnahmen fur alle Betroffenen minimiert werden. Die Anwendung der Szenario-Technik erwies sich hierbei als hilfreich und sollte bei der Beurteilung komplexer Risiken auch abseits von Gefahrdungsbeurteilungen in Betracht gezogen werden.

Zusammenfassung Hintergrund Das Krankheitsverständnis der Patienten sowie deren Erwartungen an das Aufklärungsgespräch und den Therapieerfolg entsprechen nicht immer den ärztlichen Zielsetzungen und Einschätzungen. Umso wichtiger ist es, dass man im Aufklärungsgespräch gezielt auf Erwartungen und Wissenslücken der Patienten eingehen kann, insbesondere wenn es um den therapeutischen Erfolg geht. Das Ziel dieser Arbeit ist die Erhebung des krankheitsbezogenen Wissensstands und die Evaluierung der Erwartungen von Patienten in ophthalmologischer Behandlung. Methode Mittels überwiegend geschlossener Fragen wurden in einer ophthalmologischen Ambulanz einer Universitätsklinik konsekutiv 100 Patienten anonym und strukturiert befragt. Die Antwortmöglichkeiten wurden überwiegend als Einzelauswahl auf einer Ratingskala vorgegeben. Ergebnis 55% der Patienten hatten im Vorfeld einen ophthalmologischen Eingriff erlebt, 36% mindestens 2 ophthalmologische Eingriffe. Mehr als die Hälfte der Patienten hatte sich nicht näher mit dem bevorstehenden Eingriff beschäftigt (52%). Am meisten hatten die Patienten Angst vor Komplikationen (59%), am wenigsten vor der Betäubung (29%). Am wichtigsten war den Patienten eine Aufklärung über Komplikationen und sie wünschten sich am meisten Informationen über die Auswirkungen des Eingriffs auf den Alltag. Schlussfolgerung Etwa die Hälfte der Patienten hatte sich im Vorfeld des Aufklärungsgesprächs nicht mit dem erforderlichen operativen Eingriff beschäftigt. Eine verständliche Aufklärung hinsichtlich der Erfolgsraten und der möglichen postoperativen Beeinträchtigungen sowie die Bereitstellung von übersichtlichem Aufklärungsmaterial erscheinen maßgeblich. So könnten über die Klinikhomepage Patienten im Vorfeld eines operativen Eingriffs allgemeine Informationen angeboten werden. Neue Medien scheinen für Patienten in diesem Zusammenhang bisher allerdings noch eine untergeordnete Rolle zu spielen.

Zusammenfassung Hintergrund Die intravitreale operative Medikamenteneingabe (IVOM) ist eine der häufigsten ophthalmologischen Operationen. Eine hohe Therapieadhärenz ist erforderlich, um einen guten Behandlungserfolg zu erreichen. Da der Wissensstand der Patienten um Krankheit und Therapie mit einer erhöhten Therapieadhärenz assoziiert ist, wurde dieser systematisch erhoben. Patienten und Methode Die Studie wurde als explorative Befragung konzipiert. Insgesamt wurden im Zeitraum von November bis Dezember 2016 100 konsekutive Patienten der Ambulanz einer Universitätsaugenklinik ein anonymisierter, strukturierter Fragebogen mit mehrheitlich geschlossenen Fragen ausgehändigt. Die Auswertung erfolgte deskriptiv. Ergebnisse Das mediane Alter betrug 73 Jahre. Über die Hälfte der Patienten hatte bereits 3 oder mehr IVOMs an einem Auge bekommen. Die häufigste Erkrankung war eine altersbezogene Makuladegeneration (52%). 64% der Patienten erhofften sich eine Verbesserung des Sehvermögens. 42% der Patienten konnten das verwendete Präparat nicht benennen. 55% der Patienten fühlten sich ausreichend aufgeklärt. 69% der Patienten konnten nicht einschätzen, wie häufig eine Endophthalmitis nach IVOM auftritt. Schlussfolgerung Der Wissensstand der Patienten bez. Augenerkrankung, Zielsetzung der Therapie und postoperativen Komplikationen wies trotz vorheriger ausführlicher Aufklärung Lücken auf. Standardisierte Informationsblätter sind von den Patienten gewünscht und können helfen, den Wissensstand sowie die Therapieadhärenz zu verbessern.

Digital transformation in healthcare presents enormous challenges as it partially redefines care processes and interaction between patients and doctors. In order to seize opportunities to improve patient care as well as patient safety by using digital innovations, arising patient safety risks due to these changes have to be considered and addressed. The German Coalition for Patient Safety, the Austrian Network for Patient Safety and the Swiss Foundation for Patient Safety decided to develop a recommendation for members of all professional groups in healthcare to sensitize for arising risks, inform about cause-effect relationships and to empower professionals to perform an individual risk-benefit-assessment for existing and upcoming digital innovations. In May 2017 the German Coalition on Patient Safety implemented its working group Digitization and Patient Safety with its subgroup Digitization and Risk Management. Based on open brainstorming of experts followed by a nominal group technique process the most relevant risks for patient safety arising from digitization were identified and assessed by using a modified scenario analysis. After internal consultation of all members of the German Coalition for Patient Safety and all executive boards of participation associations, the recommendation was published at the annual meeting of the German Coalition for Patient Safety in May 2018. We identified six core risks that were assessed by modified scenario technique: insufficient protection of the IT system from external attacks, insufficient protection of the IT system from unauthorized access, non-availability of IT system or patient data, handing over data to external service providers, unsafe embedding of medical devices in IT systems and insufficient digital literacy of healthcare professionals. In addition, we developed a checklist for the self-assessment of risks arising from implementing digital innovation, using risk criteria according to ONR 49002-2:2014, and provided key questions for decision makers. On the basis of the approach described a multiprofessional and intersectoral recommendation for clinical core risks associated with digitization in healthcare was developed within a 12-month period. The dissemination of this recommendation in German language can be regarded as very successful since the German Coalition for Patient Safety received more than 22,000 requests for paper copies, and 1,200 downloads of this open-access publication have been registered. An English version of this recommendation will soon be available.

(1) Background: Patient safety is a pressing issue in healthcare. Besides economical and organizational issues, human factors play a crucial role in providing safe care. Safe and clear communication on both the healthcare workers’ and patients’ sides contribute to the avoidance of medical errors and increase patients’ and healthcare workers’ satisfaction. Globally, the incidence of experiencing at least one adverse event in obstetrics is about 10%, of which half are classified as preventable. According to international research, improving communication skills may decrease preventable adverse events. The research question was to what extent communication training for pregnant women impacts the quality of communication and mutual understanding during birth. (2) Methods: Communication interventions with pregnant women were conducted in two German university obstetric departments in a mixed methods research design, based on the Health Action Process Approach. The online classes covered the awareness of personal wishes, the understanding and usage of communication strategies, self-efficacy and empathy. This study presents the qualitative results. Out of 142 mothers who answered two questionnaires before the communication training and after the birth, 24 in-depth semistructured interviews were conducted to explore the subjective impact of the communication training. The results were analyzed with qualitative content analysis. (3) Results: The majority of participants felt incentivized to be aware of their personal wishes for birth and to express them. Perceived positive experiences with sufficient competency in communication, empathy and mutual understanding outweighed negative treatments and experiences in the hospital, some of which could be attributed to structural problems. (4) Discussion: The reported positive effects of the communication training underline the need but also the potential for communication lessons to reflect and improve communication skills in obstetrics. However, negative experiences due to structural problems in the healthcare system may be buffered by communication skills but not solved.

A version of the Institute for Safe Medication Practices (ISMP) questionnaire adapted to the Austrian inpatient setting was used to sample the estimates of a group of experts regarding the level of medication safety in a level II hospital. To synthesize expert opinions on a group level reproducibly, classical Delphi method elements were combined with an item weight and performance weight decision-maker. This newly developed information synthesis method was applied to the sample dataset to examine method applicability. Method descriptions and flow diagrams were generated. Applicability was then tested by creating a synthesis of individual questionnaires. An estimate of the level of medication safety in an Austrian level II hospital was, thus, generated. Over the past two decades, initiatives regarding patient safety, in general, and medication safety, in particular, have been gaining momentum. Questionnaires are state of the art for assessing medication practice in healthcare facilities. Acquiring consistent data about medication in the complex setting of a hospital, however, has not been standardized. There are no publicly available benchmark datasets and, in particular, there is no published method to reliably synthesize expertise regarding medication safety on an expert group level. The group-level information synthesis method developed in this study has the potential to synthesize information about the level of medication safety in a hospital setting more reliably than unstructured approaches. A medication safety level estimate for a representative Austrian level II hospital was generated. Further studies are needed to establish convergence characteristics and benchmarks for medication safety on a larger scale.

Background Second victims, defined as healthcare team members being traumatised by an unanticipated clinical event or outcome, are frequent in healthcare. Evidence of this phenomenon in Germany, however, is sparse. Recently, we reported the first construction and validation of a German questionnaire. This study aimed to understand this phenomenon better in a sample of young (

BACKGROUND: Mycosis fungoides (MF) is the most common type of cutaneous T‐cell lymphoma, a malignant, chronic disease initially affecting the skin. Several therapies are available, which may induce clinical remission for a time. This is an update of a Cochrane Review first published in 2012: we wanted to assess new trials, some of which investigated new interventions. OBJECTIVES: To assess the effects of interventions for MF in all stages of the disease. SEARCH METHODS: We updated our searches of the following databases to May 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched 2 trials registries for additional references. For adverse event outcomes, we undertook separate searches in MEDLINE in April, July and November 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) of local or systemic interventions for MF in adults with any stage of the disease compared with either another local or systemic intervention or with placebo. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. The primary outcomes were improvement in health‐related quality of life as defined by participants, and common adverse effects of the treatments. Key secondary outcomes were complete response (CR), defined as complete disappearance of all clinical evidence of disease, and objective response rate (ORR), defined as proportion of patients with a partial or complete response. We used GRADE to assess the certainty of evidence and considered comparisons of psoralen plus ultraviolet A (PUVA) light treatment as most important because this is first‐line treatment for MF in most guidelines. MAIN RESULTS: This review includes 20 RCTs (1369 participants) covering a wide range of interventions. The following were assessed as either treatments or comparators: imiquimod, peldesine, hypericin, mechlorethamine, nitrogen mustard and intralesional injections of interferon‐α (IFN‐α) (topical applications); PUVA, extracorporeal photopheresis (ECP: photochemotherapy), and visible light (light applications); acitretin, bexarotene, lenalidomide, methotrexate and vorinostat (oral agents); brentuximab vedotin; denileukin diftitox; mogamulizumab; chemotherapy with cyclophosphamide, doxorubicin, etoposide, and vincristine; a combination of chemotherapy with electron beam radiation; subcutaneous injection of IFN‐α; and intramuscular injections of active transfer factor (parenteral systemics). Thirteen trials used an active comparator, five were placebo‐controlled, and two compared an active operator to observation only. In 14 trials, participants had MF in clinical stages IA to IIB. All participants were treated in secondary and tertiary care settings, mainly in Europe, North America or Australia. Trials recruited both men and women, with more male participants overall. Trial duration varied from four weeks to 12 months, with one longer‐term study lasting more than six years. We judged 16 trials as at high risk of bias in at least one domain, most commonly performance bias (blinding of participants and investigators), attrition bias and reporting bias. None of our key comparisons measured quality of life, and the two studies that did presented no usable data. Eighteen studies reported common adverse effects of the treatments. Adverse effects ranged from mild symptoms to lethal complications depending upon the treatment type. More aggressive treatments like systemic chemotherapy generally resulted in more severe adverse effects. In the included studies, CR rates ranged from 0% to 83% (median 31%), and ORR ranged from 0% to 88% (median 47%). Five trials assessed PUVA treatment, alone or combined, summarised below. There may be little to no difference between intralesional IFN‐α and PUVA compared with PUVA alone for 24 to 52 weeks in CR (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.87 to 1.31; 2 trials; 122 participants; low‐certainty evidence). Common adverse events and ORR were not measured. One small cross‐over trial found once‐monthly ECP for six months may be less effective than twice‐weekly PUVA for three months, reporting CR in two of eight participants and ORR in six of eight participants after PUVA, compared with no CR or ORR after ECP (very low‐certainty evidence). Some participants reported mild nausea after PUVA but no numerical data were given. One participant in the ECP group withdrew due to hypotension. However, we are unsure of the results due to very low‐certainty evidence. One trial comparing bexarotene plus PUVA versus PUVA alone for up to 16 weeks reported one case of photosensitivity in the bexarotene plus PUVA group compared to none in the PUVA‐alone group (87 participants; low‐certainty evidence). There may be little to no difference between bexarotene plus PUVA and PUVA alone in CR (RR 1.41, 95% CI 0.71 to 2.80) and ORR (RR 0.94, 95% CI 0.61 to 1.44) (93 participants; low‐certainty evidence). One trial comparing subcutaneous IFN‐α injections combined with either acitretin or PUVA for up to 48 weeks or until CR indicated there may be little to no difference in the common IFN‐α adverse effect of flu‐like symptoms (RR 1.32, 95% CI 0.92 to 1.88; 82 participants). There may be lower CR with IFN‐α and acitretin compared with IFN‐α and PUVA (RR 0.54, 95% CI 0.35 to 0.84; 82 participants) (both outcomes: low‐certainty evidence). This trial did not measure ORR. One trial comparing PUVA maintenance treatment to no maintenance treatment, in participants who had already had CR, did report common adverse effects. However, the distribution was not evaluable. CR and OR were not assessable. The range of treatment options meant that rare adverse effects consequently occurred in a variety of organs. AUTHORS' CONCLUSIONS: ​​There is a lack of high‐certainty evidence to support decision making in the treatment of MF. Because of substantial heterogeneity in design, missing data, small sample sizes, and low methodological quality, the comparative safety and efficacy of these interventions cannot be reliably established on the basis of the included RCTs. PUVA is commonly recommended as first‐line treatment for MF, and we did not find evidence to challenge this recommendation. There was an absence of evidence to support the use of intralesional IFN‐α or bexarotene in people receiving PUVA and an absence of evidence to support the use of acitretin or ECP for treating MF. Future trials should compare the safety and efficacy of treatments to PUVA, as the current standard of care, and should measure quality of life and common adverse effects.

Background Second victims, defined as health care team members being traumatized by an unanticipated clinical event or outcome, are supposed to be a common phenomenon in health care. Surveys in the US health care system indicate high incidence rates among physicians between 10 and 44%. However, no systematic assessment of second victims in health care in German speaking countries has been published yet and no validated German questionnaire for assessing incidence of and impact on second victims exists. Therefore, we initiated the SeViD (Second Victims im Deutschsprachigen Raum/second victims in German speaking countries) project and developed a German questionnaire for the assessment of second victim incidents. Methods Based on an intensive literature review of available questionnaires in English we defined a preliminary version of our questionnaire consisting of 4 domains and 14 items. This version was subject to cognitive pretesting using paraphrasing, probing and think aloud methods in order to ensure content validity. Retest reliability of second victim symptoms was assessed three weeks after the initial pretest. Results Fifteen health care professionals (physicians, nurses, therapeutic and diagnostic professions and administrative staff) of hospitals in Germany (n=6) and Austria (n=9) with or without previous second victim experience participated as volunteers for all pretests after informed consent. Seven items in three domains were slightly modified based on cognitive pretests. Retest reliability for second victim symptoms was rho = 0.76. Mean duration of completion for this questionnaire took 9:01 (±3:05) minutes in case of a previous second victim experience and otherwise 4:19 (±0:59) minutes and was regarded acceptable by all volunteers. No volunteer regarded any question to be inappropriate. Conclusion We successfully developed a validated questionnaire assessing the impact of the second victim phenomenon in inpatient health care facilities. This questionnaire will be used in different settings for health care professionals and for stand-alone baseline assessment as well as pre/post-survey along with complex educational interventions to reduce negative impacts of the second victim phenomenon.

Patient safety is an important objective in health care. Preventable adverse events (pAEs) as the counterpart to patient safety are harmful incidents that fell behind health care standards and have led to temporary or permanent harm or death. As safe communication and mutual understanding are of crucial importance for providing a high quality of care under everyday conditions, we aimed to identify barriers and facilitators that impact safe communication in obstetrics from the subjective perspective of health care workers. A qualitative study with 20 semi-structured interviews at two university hospitals in Germany was conducted to explore everyday perceptions from a subjective perspective (subjective theories). Physicians, midwives, and nurses in a wide span of professional experience and positions were enrolled. We identified a structural area of conflict at the professional interface between midwives and physicians. Mandatory interprofessional meetings, acceptance of subjective mistakes, mutual understanding, and debriefings of conflict situations are reported to improve collaboration. Additionally, emergency trainings, trainings in precise communication, and handovers are proposed to reduce risks for pAEs. Furthermore, the participants reported time-constraints and understaffing as a huge burden that hinders safe communication. Concluding, safety culture and organizational management are closely entwined and strategies should address various levels of which communication trainings are promising.

BACKGROUND: Percutaneous dilatational tracheostomy (PDT) is one of the most common bedside surgical procedures performed in critically ill adults, on intensive care units (ICUs), who require long‐term ventilation. PDT is associated with relevant life‐threatening complications: Cuff rupture or accidental extubation may lead to hypoxia, aspiration or loss of airway. Puncture of the oesophagus, or creating a false passage during dilatation or replacement of the tracheostomy tube, can lead to pneumothorax or emphysema. Wound infections may occur which can cause mediastinits, especially after creation of false passage or in early tracheotomized post‐sternotomy patients after cardiac surgery. During the procedure, the patient's airway can be secured with an endotracheal tube (ETT) or a laryngeal mask airway (LMA). This is an updated version of the review first published in 2014. OBJECTIVES: To assess the safety and effectiveness of LMA versus ETT in critically ill adults undergoing PDT on the ICU. SEARCH METHODS: We searched the following databases to 9 January 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase. We searched for reports of ongoing trials in the metaRegister of Controlled Trials (mRCT). We handsearched for relevant studies in conference proceedings of five relevant annual congresses. We contacted study authors and experts concerning unpublished data and ongoing trials. We searched for further relevant studies in the reference lists of all included trials and of relevant systematic reviews. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared use of laryngeal mask airways versus endotracheal tubes in critically ill adults undergoing elective PDT in the ICU, without injuries to or diseases of the face or neck. We imposed no restrictions with regard to language, timing or technique of PDT performed. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility and methodological quality of each study and carried out data extraction. Our primary outcomes were all‐cause mortality, procedure‐related mortality and tally of participants with one or more serious adverse events. Where possible, we combined homogeneous studies for meta‐analysis. We used Cochrane's 'Risk of bias' tool and used GRADE to assess the quality of evidence for key outcomes. MAIN RESULTS: We included nine RCTs in this review involving 517 participants. Studies had a high or unclear risk of bias. The main reason for this was low methodological quality or missing data, even after study authors were contacted. Study size was generally small, with a minimum of 40, and a maximum of 73 participants. In one study (40 participants), three deaths in the LMA group and two deaths in the ETT group were reported, although none of the deaths were related to the procedure (very low‐quality evidence). Five studies (281 participants) reported on procedure‐related deaths, stating that no procedure‐related death occurred at all (very low‐quality evidence). It is uncertain whether there is a difference in the number of people experiencing one or more serious adverse event(s) between LMA and ETT (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.41 to 1.80; 467 participants, 8 studies, very low‐quality evidence). The duration of the procedure may be shorter in the LMA group (mean difference (MD) ‐1.46 minutes, 95% CI ‐1.92 to ‐1.01 minutes; 6 studies, 324 participants, low‐quality evidence). However failure of procedure, as allocated by randomization, requiring conversion to any other procedure, may be higher in the LMA group (RR 2.82, 95% CI 1.22 to 6.52; 8 studies, 439 participants, low‐quality evidence). We did not find any clear evidence of a difference between ETT and LMA groups for all other outcomes. Only one study provided follow‐up data for late complications related to the intervention, showing no clear evidence of benefit for any treatment group. AUTHORS' CONCLUSIONS: Evidence on the safety of LMA for PDT is too limited to allow conclusions to be drawn on either its efficacy or safety compared with ETT. Although the LMA procedure may shorten the period during which the airway is insecure, it may also lead to higher conversion rates. Also, late complications have not been investigated sufficiently. These results are primarily based on single‐centre trials with small sample sizes, and therefore the level of evidence remains low. Studies with low risk of bias focusing on late complications and relevant patient‐related outcomes are necessary for definitive conclusions on safety issues related to this procedure. The dependency of the successful placement of a LMA on the type of LMA used should also be further assessed. There are two studies awaiting classification that may alter the conclusions once assessed.

General anesthesia is commonly used in pediatric inpatient surgery. It can be induced and maintained by either intravenous or volatile anesthetic agents. We aimed to elucidate whether intravenous or volatile anesthetic agents are superior with regards to preventing anesthesia-related complications.Using a predefined standardized study protocol we conducted a systematic review of randomized controlled trials (RCTs) with meta-analysis where appropriate searching the following data bases: CENTRAL, MEDLINE, EMBASE, metaRegister of Controlled Trials (until June 2016).We included any RCT comparing the adverse effects of intravenous or volatile anesthetic agents in pediatric inpatients. More specifically, primary endpoints were the appearance of cardiopulmonary complications or postoperative nausea and vomiting (PONV) or any cognitive dysfunction within 24 h following general anesthesia. Secondary endpoints were any other complication besides the aforementioned primary endpoints.In total, nine RCTs (762 children) were analyzed. Regarding primary endpoints, the use of propofol during strabismus surgery significantly increased the relative risk (RR) of oculocardiac reflex (RR 4.96, 95% confidence interval [CI]: 3.13-7.87, p 0.00001; two studies, 257 children). PONV was significantly less frequent after general anesthesia with intravenous than with volatile anesthetic agents (RR 0.68, 95% CI: 0.48-0.98, p = 0.04; five studies, 563 children). We did not find identify any further difference with regards to the predefined primary or secondary endpoints due to clinical or statistical heterogeneity.Taken together, propofol increased the risk of oculocardiac reflex whereas PONV was less frequent following intravenous anesthetics compared to volatile anesthetics. The study results may help tailoring the use of either intravenous of volatile anesthetics onto the needs of pediatric inpatients. Given the clinical or statistical heterogeneity among the studies, we call for a scientific effort to increase the body of evidence on anesthetic agents in pediatric general anesthesia.

Zusammenfassung Einleitung In einem 2011/12 durchgefuhrten Survey zur Aus-, Weiter- und Fortbildungssituation in Evidenzbasierter Medizin (EbM) in Deutschland, Osterreich und der Schweiz wurde eine deutliche Zunahme an Aus-, Weiter-, und Fortbildungsveranstaltungen beschrieben, die fur verschiedene Zielgruppen angeboten werden. Um Aussagen uber einen moglichen berufsgruppenspezifischen bzw. ubergreifenden Charakter von EbM-Bildungsangeboten machen zu konnen, wurden unter der Frage von Unterschieden und Gemeinsamkeiten die Inhalte und Strukturen der Veranstaltungen miteinander verglichen. Methoden Im ersten Schritt wurden verschiedene Institutionen im Gesundheitswesen kontaktiert, die Teilnehmer der EbM-Akademie als key informants befragt und die Mitglieder der deutschsprachigen allgemeinmedizinischen Fachgesellschaften und des Deutschen Netzwerkes Evidenzbasierte Medizin angeschrieben, um potentielle Anbieter von Veranstaltungen zu identifizieren. Im zweiten Schritt wurden pilotierte Detailfragebogen versendet, die eine zielgruppenspezifische Analyse der Inhalte, der Strukturen und der didaktischen Methoden ermoglichten. Ergebnisse Von 185 beschriebenen Veranstaltungen richten sich 117 (63,8%) an Studierende, 70 (37,8%) an Arzte und 55 (29,7%) an Pflegende und Angehorige anderer Gesundheitsfachberufe. Weitere grose Zielgruppen sind allgemein Interessierte im Gesundheitswesen mit 38 (20,5%) und Patienten mit 18 (9,7%) Veranstaltungen (Mehrfachnennungen moglich). Wahrend Studierende vor allem in Pflichtveranstaltungen im Seminar-, Kurs-, oder Vorlesungsformat mit einer hoheren Teilnehmerzahl unterrichtet werden, finden die Angebote fur die anderen Zielgruppen neben Seminaren und Kursen haufig als Workshops in kleineren Gruppen auf freiwilliger Basis in vergleichbarer Stundenzahl statt. Inhaltlich werden in allen Zielgruppen vorwiegend die ersten drei Schritte der EbM nach Sackett an Teilnehmer mit wenigen Vorkenntnissen vermittelt. Spezielle Inhalte sind unterschiedlich verteilt und zeigen einen gewissen Zuschnitt auf die entsprechenden Berufsgruppen. Diskussion und Schlussfolgerung Strukturelle Unterschiede in den Veranstaltungen verschiedener Zielgruppen sind am ehesten auf unterschiedliche Rahmenbedingungen in Beruf und Ausbildung zuruckzufuhren. Die inhaltlichen Parallelen weisen jedoch auf deutliche Ubereinstimmungen in der Vermittlung der Grundlagen hin, wobei durch spezielle Inhalte individuelle Schwerpunkte gesetzt werden.

Zusammenfassung Einleitung Die Bekanntheit des Konzepts der Evidenzbasierten Medizin (EbM) stieg in den letzten 15 Jahren auch im deutschsprachigen Raum, wobei schwer abzuschatzen ist, wie verbreitet die wirklichen Kenntnisse um die Inhalte der EbM mit ihren 5 Schritten nach Sackett sind. Daten aus dem Jahre 2006 zeigen zum einen die Verankerung von EbM in bis dato weniger als der Halfte der deutschen medizinischen Fakultaten sowie eine Unterversorgung an Angeboten in EbM Aus-, Weiter- und Fortbildung im gesamten deutschsprachigen Raum. Ziel der vorliegenden Befragung zu Aus-, Weiter- und Fortbildungsangeboten in EbM ist die strukturierte Darstellung der Aus-, Weiter- und Fortbildungsangebote in Evidenzbasierter Praxis im deutschsprachigen Raum. Methoden In einem zweistufigen Survey wurden im ersten Schritt mit insgesamt 551 Anschreiben zunachst die medizinischen Fakultaten, die Hochschulen, die Arztekammern, die Kassenarztlichen Vereinigungen in Deutschland, die Deutsche Krankenhausgesellschaft, der Medizinische Dienst des Spitzenverbandes Bund der Krankenkassen e.V. (MDS) und die 30 Teilnehmer der EbM-Akademie als key informants schriftlich nach potentiellen Anbietern von EbM Veranstaltungen befragt. Via E-Mail wurden die Mitglieder der deutschsprachigen allgemeinmedizinischen Fachgesellschaften, des DNEbM und ehemalige Kursteilnehmer und Kontaktpersonen bekannter EbM Kurse angeschrieben. Im zweiten Schritt wurden pilotierte Detailfragebogen mit 36 Fragen in den funf Kategorien Rahmen und Struktur, Teilnehmerbeschreibung, Inhalte und didaktische Methoden, Evaluation und Publikation, sowie Planung und Bekanntmachung versendet. Ergebnisse Es wurden 185 Veranstaltungen gemeldet, davon finden 80% in Deutschland, 13% in Osterreich und 7% in der Schweiz statt. Das Angebot ist in 82.6% der Falle entweder ein Seminar, ein Kurs oder ein Workshop mit im Median 20 Teilnehmern und dauert durchschnittlich 17.9 Zeitstunden. Die Veranstaltungen adressieren in erster Linie Studierende (63.2%), Arzte (37.8%), Pflegepraktiker und Angehorige anderer Gesundheitsfachberufe (29.7%) mit wenig oder keinem Vorwissen in EbM. Die Schritte 1-3 der Evidenzbasierten Medizin (Fragenformulierung, Suche und Bewertung der Evidenz) werden jeweils in mehr als 75% der Veranstaltungen unterrichtet, wahrend dieses fur die Schritte 4 und 5 (Praxisumsetzung, Evaluation) nur in 53.9% respektive 33.3% der Falle gilt. Diskussion und Schlussfolgerungen Im deutschsprachigen Raum findet sich im Vergleich zu 2006 eine deutlich wachsende Anzahl an Aus-, Weiter- und Fortbildungsveranstaltungen in EbM. Diese adressieren verschiedenste Zielgruppen und fokussieren inhaltlich auf die ersten Schritte der EbM.

Die Punktionstracheotomie ist ein fester Bestandteil der intensivmedizinischen Beatmungstherapie und bietet viele Vorteile gegenuber der prolongierten orotrachealen Intubation. Fur den optimalen Zeitpunkt zur Tracheotomie gibt es gegenwartig jedoch noch keine Evidenz. Der Eingriff wird in Allgemeinanasthesie unter fiberoptischer Kontrolle durchgefuhrt, wobei die Ciaglia Blue-Rhino-Technik am weitesten verbreitet ist. Ein neuartiges Verfahren stellt die CiagliaBlue-Dolphin-Technik dar, bei der eine radiare Dilatation mithilfe eines flussigkeitsgefullten Hochdruckballons erfolgt. Unter Beachtung der Kontraindikationen (z.B. schwierige Intubation, keine sichere Identifikation laryngotrachealer Landmarken, hochgradige Gerinnungsstorungen) ist die Komplikationsrate aller Verfahren gering, wobei der Einsatz der Sonografie zu einer weiteren Erhohung der Sicherheit beitragen kann. Schlussendlich muss beachtet werden, dass es sich bei der Punktionstracheotomie um einen Elektiveingriff handelt, fur den eine rechtsgultige Einwilligung des Patienten oder seines Betreuers erforderlich ist.

Background The incidence of ischemia might be increased in the surgical repair of atherosclerotic unruptured aneurysms compared to non-atherosclerotic aneurysms. The atherosclerotic wall might increase the occurrence of thrombembolic events or its rigidity might endanger the occlusion of perforators within the aneurysm vicinity. Methods 87 patients (53 patients without and 34 patients with atherosclerotic unruptured aneurysms, 50.5±9.7 years) were analyzed for severity of atherosclerosis within the aneurysm and the aneurysm bearing vessel, surgical maneuvers, intraoperative alterations in evoked potentials and clinical and neuroradiological results. Results Temporary vessel occlusion (25% vs. 50%, p =0.021), repositioning of a permanent clip (21% vs. 56%, p =0.001) and aneurysm remnants (2% vs. 18%, p =0.012) occurred more often in patients with atherosclerotic aneurysms. At 6 months, 3/34 patients with atherosclerosis (8.8%) had an unfavorable outcome, all patients without atherosclerosis had a favorable outcome ( p =0.056). Conclusion The surgical repair of unruptured aneurysms is safe but patients with atherosclerotic altered vessels and aneurysms accounted to a minor increase in unfavorable outcome and an increased risk of morbidity at 6 months postoperatively. This factor should be taken into consideration when performing surgery of atherosclerotic, unruptured aneurysms.

Die Untersuchung medizinischer Behandlungsfehler liefert haufig nicht die Schuld Einzelner, sondern systemische Mangel in Organisationen und Prozessablaufen zu Tage. Die Analyse dieser Zwischenfalle schafft ein tieferes Verstandnis fur die Mechanismen und Ursachen, die diesen Behandlungsfehlern zugrunde liegen. Dieses Verstandnis wiederum ermoglicht die Ableitung konkreter und wirksamer Masnahmen zur Vermeidung kunftiger Behandlungsfehler. Das London Protokoll (Taylor Adams und Vincent), basierend auf den Forschungsarbeiten von James Reason, bietet eine systematische Struktur zur Analyse und Bewaltigung schwerer Zwischenfalle. Die systemischen Einflussfaktoren des Schadensfalles werden durch Sammlung und Verdichtung verfugbarer Informationen identifiziert und analysiert. Aufgrund der Detailtiefe der Untersuchung liefert die Schadenfallanalyse als Gegenstuck zu CIRS-Plattformen wichtige Informationen, die weit uber die einfache Analyse von Beinahe-Zwischenfallen hinausgehen. Anhand eines konkreten Schadensfalls aus der praklinischen Notfallversorgung eines Patienten wird der Prozessablauf des London Protokolls dargestellt.

Hintergrund Der Nutzen perioperativ verabreichter β-Blocker bei nichtkardiochirurgischen Eingriffen wird nach wie vor kontrovers diskutiert. In zahlreichen Einzelstudien konnten keine signifikanten Vor- oder Nachteile auf Grund niedriger Ereignisraten und kleiner Fallzahlen festgestellt werden.

Die antifibrinolytische Therapie mit dem Serinproteaseinhibitor Aprotinin oder den Lysinanaloga e-Aminokapronsaure oder Tranexamsaure ist eine Therapiemasnahme, um den perioperativen Blutverlust kardiochirurgischer Patienten zu reduzieren. In einer internationalen, prospektiven, nichtrandomisierten Phase-4-Beobachtungsstudie untersuchten Mangano et al. die Wirksamkeit und das Nebenwirkungsprofil von Aprotinin, e-Aminokapronsaure und Tranexamsaure im Vergleich zu keiner perioperativen antifibrinolytischen Therapie bei insgesamt 4374 Patienten, die sich kardiochirurgischen Eingriffen mit extrakorporaler Zirkulation unterzogen. Die Ergebnisse dieser Beobachtungsstudie stellen aus Sicht von Mangano et al. die Sicherheit und Effektivitat von Aprotinin zur Reduktion des perioperativen Blutverlustes bei herzchirurgischen Patienten infrage. Auch die Autoren dieses Beitrages kommen trotz kritischer Betrachtung der Studie und der Studienergebnisse von Mangano et al. zu dem Schluss, dass es derzeit angesichts der Verfugbarkeit preiswerterer, aquipotenter antifibrinolytischer Alternativen in Deutschland sinnvoll erscheint, Tranexamsaure dem Einsatz von Aprotinin, wenn moglich, vorzuziehen.

Background Percutaneous dilatational tracheostomy (PDT) is one of the most common bedside surgical procedures performed in critically ill adult patients on intensive care units (ICUs) who require long-term ventilation. PDT is generally associated with relevant life-threatening complications (e.g. cuff rupture leading to possible hypoxia or aspiration, puncture of the oesophagus, accidental extubation, mediastinitis, pneumothorax, emphysema). The patient's airway can be secured with an endotracheal tube (ETT) or a laryngeal mask airway (LMA). Objectives To assess the safety and effectiveness of ETT versus LMA in critically ill adult patients undergoing PDT on the ICU. This review addresses the following research questions. 1. Is an LMA more effective than an ETT in terms of procedure-related or all-cause mortality? 2. Is an LMA safer than an ETT in terms of procedure-related life-threatening complications during a PDT procedure? 3. Does use of an LMA influence the conditions for performing a tracheostomy (e.g. duration of procedure)? Search methods We searched the Cochrane Database of Systematic Reviews (CDSR); the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 6 (part ofThe Cochrane Library); MEDLINE (from 1984 to 27 June 2013) and EMBASE (from 1984 to 27 June 2013). We searched for reports of ongoing trials in the metaRegister of Controlled Trials (mRCT). We handsearched for relevant studies in conference proceedings of the International Symposium on Intensive Care and Emergency Medicine (ISICEM), the Annual Congress of the European Society of Intensive Care Medicine (ESICM), the Annual Congress of the Society of Critical Care Medicine (SCCM), the American Thoracic Society (ATS) and the Annual Meeting of the American College of Chest Physicians (ACCP). We contacted study authors and experts concerning unpublished data and ongoing trials. We searched for further relevant studies in the reference lists of all included trials and of relevant systematic reviews identified in theCDSR. We reran the search in March 2017. Two potential new studies of interest were added to a list of ‘Studies awaiting Classification' and will be incorporated into the formal review findings during the review update. Selection criteria We included randomized controlled trials (RCTs) that compared use of endotracheal tubes versus laryngeal mask airways in critically ill adult patients undergoing PDT on the ICU. We imposed no restrictions with regard to language, timing or technique of PDT performed. Data collection and analysis Two review authors independently assessed the eligibility and methodological quality of each study and carried out data extraction. We resolved disagreements by discussion. Our primary outcomes were all-cause mortality, procedure-related mortality and tally of participants with one or more serious adverse events. When available, we reported on our secondary outcomes, which included duration of the procedure, failure of the procedure requiring conversion to any other procedure, time to extubation after tracheostomy, length of ICU stay after tracheostomy, length of hospital stay after tracheostomy and any other serious adverse events. When possible, we combined homogeneous studies for meta-analysis. We used the risk of bias tool of The Cochrane Collaboration to assess the internal validity of all included studies in six different domains. Main results We included in this review eight RCTs involving 467 participants. There are three studies awaiting classification The included trials exclusively assessed critically ill participants (e.g. with head injury, neurological disease, multi-trauma, sepsis, acute respiratory failure (ARF) and/or chronic obstructive pulmonary disease (COPD)). Internal validity was considerably low in studies with a high or unclear risk of bias. The main reason for this was low methodological quality or missing data, even after study authors were contacted. Study size was generally small, with a minimum of 40 and a maximum of 73 participants. Only one study (40 participants) reported on overall mortality, showing no clear evidence of a difference between treatment groups (risk ratio (RR) 1.5, 95% confidence interval (CI) 0.28 to 8.04, Fisher test P value 1.0, low-quality evidence). Four studies (231 participants) reported that no procedure-related deaths occurred with any intervention. Seven studies reported the numbers of participants with adverse events, showing no clear evidence of benefit of either LMA or ETT during PDT (RR 0.73, 95% CI 0.35 to 1.52, P value 0.41, low-quality evidence). The tally of participants in included studies with adverse events ranged from 0% to 33% in the LMA group and from 0% to 50% in the ETT group. However, the duration of the procedure was significantly shorter in the LMA group (mean difference (MD) -1.46 minutes, 95% CI -1.92 to -1.01 minutes, 324 participants, P value ≤ 0.00001, low-quality evidence). No clear evidence of a difference between ETT and LMA groups was found for all other outcomes. Only one study provided follow-up data for late complications related to the intervention, showing no clear evidence of benefit for any treatment group. Authors' conclusions Evidence on the safety of LMA for PDT is too limited to allow conclusions to be drawn on its efficacy or safety compared with ETT. Although the LMA procedure is shorter because of optimal visual conditions, its effect on especially late complications has not been investigated sufficiently. Studies focusing on late complications and relevant patient-related outcomes are necessary for definitive conclusions on safety issues related to this procedure.

Die Klinik fur Anasthesiologie, Intensivmedizin und Schmerztherapie (KAIS) versorgt alle Abteilungen des Universitatsklinikums Frankfurt am Main mit Anasthesieleistungen. Sie erbringt mit ihren uber 100 arztlichen Mitarbeiterinnen und Mitarbeitern jahrlich uber 20.000 Narkoseleistungen, leitet die mit 34 Betten groste Intensivstation des Klinikums und betreut uber die Schmerzambulanz sowohl ambulante als auch stationare Patienten bei akuten und chronischen Schmerzen.

All major guidelines for antihypertensive therapy recommend weight loss; anti-obesity drugs might be a helpful option. Objectives: Primary objectives: To assess the long-term effects of pharmacologically induced reduction in body weight with orlistat, sibutramine or rimonabant on: - all cause mortality - cardiovascular morbidity - adverse events Secondary objectives: - changes in systolic and/or diastolic blood pressure - body weight reduction Eight studies comparing orlistat or sibutramine to placebo fulfilled our inclusion criteria. No relevant studies investigating rimonabant for weight loss were identified. No study included mortality and cardiovascular morbidity as a pre-defined outcome. Incidence of gastrointestinal side effects was consistently higher in orlistat treated vs. placebo treated patients. Most frequent side effects with sibutramine were dry mouth, constipation and headache. Patients assigned to weight loss diets, orlistat or sibutramine reduced their body weight more effectively than patients in the usual care/placebo groups. Blood pressure reduction in patients treated with orlistat was for systolic blood pressure (SBP): weighted mean difference (WMD): -2.5 mm Hg; 95% CI, -4.0 to -0.9 mm Hg and for diastolic blood pressure (DBP): WMD -1.9 mm Hg; 95% CI, -3.0 to -0.9 mm Hg. Meta-analysis showed DBP increase under therapy with sibutramine: WMD +3.2 mm Hg; 95%CI +1.4 to +4.9 mm Hg.

To evaluate the effect of a compulsory evidence-based medicine (EBM) seminar in critical appraisal skills and the overall acceptance of compulsory EBM seminars for Year 3 medical undergraduate students.Small group seminars by peer teaching were conducted for up to 23 undergraduates. Knowledge and skills in EBM before and after the compulsory seminars were evaluated by 2 different sets of 20 questions. To apply knowledge, each undergraduate had to analyse an individual paper case using the principles of EBM. Undergraduates gave anonymous feedback using separate evaluation sheets at the end of the seminar. Main outcome variables were changes in knowledge and skills.A total of 132 Year 3 undergraduates at the University of Frankfurt participated in a compulsory EBM seminar during the academic half-year 2003/04 as part of their regular curriculum. Complete datasets were available for evaluation from 124 undergraduates (94%). The seminars led to an overall increase in knowledge (question paper score increase from 2.37 to 7.48, 99% CI 6.61-8.36, or 216%). Transfer of knowledge into a paper case scenario was generally good, with a mean score of 49.5 (SD 5.24) out of 55 points. Feedback indicated good overall acceptance of the seminars, with a median of 2 (score range from 1 = excellent to 6 = failed).Trained medical students are effective and well accepted EBM trainers in compulsory undergraduate seminars.