@article{WernerPoppFichtneretal.2022, author = {Werner, Anne and Popp, Maria and Fichtner, Falk and Holzmann-Littig, Christopher and Kranke, Peter and Steckelberg, Anke and L{\"u}hnen, Julia and Redlich, Lisa Marie and Dickel, Steffen and Grimm, Clemens and Moerer, Onnen and Nothacker, Monika and Seeber, Christian}, title = {COVID-19 intensive care — Evaluation of public information sources and current standards of care in German intensive care units: a cross sectional online survey on intensive care staff in Germany}, series = {Healthcare}, volume = {10}, journal = {Healthcare}, number = {7}, issn = {2227-9032}, doi = {10.3390/healthcare10071315}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-281865}, year = {2022}, abstract = {Backround: In February 2021, the first formal evidence and consensus-based (S3) guidelines for the inpatient treatment of patients with COVID-19 were published in Germany and have been updated twice during 2021. The aim of the present study is to re-evaluate the dissemination pathways and strategies for ICU staff (first evaluation in December 2020 when previous versions of consensus-based guidelines (S2k) were published) and question selected aspects of guideline adherence of standard care for patients with COVID-19 in the ICU. Methods: We conducted an anonymous online survey among German intensive care staff from 11 October 2021 to 11 November 2021. We distributed the survey via e-mail in intensive care facilities and requested redirection to additional intensive care staff (snowball sampling). Results: There was a difference between the professional groups in the number, selection and qualitative assessment of information sources about COVID-19. Standard operating procedures were most frequently used by all occupational groups and received a high quality rating. Physicians preferred sources for active information search (e.g., medical journals), while nurses predominantly used passive consumable sources (e.g., every-day media). Despite differences in usage behaviour, the sources were rated similarly in terms of the quality of the information on COVID-19. The trusted organizations have not changed over time. The use of guidelines was frequently stated and highly recommended. The majority of the participants reported guideline-compliant treatment. Nevertheless, there were certain variations in the use of medication as well as the criteria chosen for discontinuing non-invasive ventilation (NIV) compared to guideline recommendations. Conclusions: An adequate external source of information for nursing staff is lacking, the usual sources of physicians are only appropriate for the minority of nursing staff. The self-reported use of guidelines is high.}, language = {en} } @article{WeibelPoppReisetal.2023, author = {Weibel, Stephanie and Popp, Maria and Reis, Stefanie and Skoetz, Nicole and Garner, Paul and Sydenham, Emma}, title = {Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis}, series = {Research Synthesis Methods}, volume = {14}, journal = {Research Synthesis Methods}, number = {3}, doi = {10.1002/jrsm.1599}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-318236}, pages = {357 -- 369}, year = {2023}, abstract = {Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false. Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms to identify and manage problematic studies to avoid misleading findings. As evidence synthesis authors of the Cochrane COVID-19 review on ivermectin, we identified many problematic studies in terms of research integrity and regulatory compliance. Through iterative discussion, we developed a research integrity assessment (RIA) tool for randomized controlled trials for the update of this Cochrane review. In this paper, we explain the rationale and application of the RIA tool in this case study. RIA assesses six study criteria: study retraction, prospective trial registration, adequate ethics approval, author group, plausibility of methods (e.g., randomization), and plausibility of study results. RIA was used in the Cochrane review as part of the eligibility check during screening of potentially eligible studies. Problematic studies were excluded and studies with open questions were held in awaiting classification until clarified. RIA decisions were made independently by two authors and reported transparently. Using the RIA tool resulted in the exclusion of >40\% of studies in the first update of the review. RIA is a complementary tool prior to assessing "Risk of Bias" aiming to establish the integrity and authenticity of studies. RIA provides a platform for urgent development of a standard approach to identifying and managing problematic studies.}, language = {en} } @article{RiemerKrankeHelfetal.2021, author = {Riemer, Manuel and Kranke, Peter and Helf, Antonia and Mayer, Debora and Popp, Maria and Schlesinger, Tobias and Meybohm, Patrick and Weibel, Stephanie}, title = {Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting}, series = {BMC Anesthesiology}, volume = {21}, journal = {BMC Anesthesiology}, doi = {10.1186/s12871-021-01464-w}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-265518}, year = {2021}, abstract = {Background: Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. Methods: The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the 'Cochrane Risk of bias' assessment tool 1.0. Results: In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22\% (75/334) were registered. Among the registered trials, 36\% (27/75) were pro- and 64\% (48/75) were retrospectively registered. 41\% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22\% (6/27) were incompletely registered and assessed as unclear risk, and 37\% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32\%), a new primary outcome (26\%), and different outcome assessment times (26\%). Among trials with high risk of selective outcome reporting 80\% favoured at least one statistically significant result. Registered trials were assessed more often as 'overall low risk of bias' compared to non-registered trials (64\% vs 28\%). Conclusions: In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future.}, language = {en} } @article{ReisPoppSchmidetal.2021, author = {Reis, Stefanie and Popp, Maria and Schmid, Benedikt and Stegemann, Miriam and Metzendorf, Maria-Inti and Kranke, Peter and Meybohm, Patrick and Weibel, Stephanie}, title = {Safety and efficacy of intermediate- and therapeutic-dose anticoagulation for hospitalised patients with COVID-19: a systematic review and meta-analysis}, series = {Journal of Clinical Medicine}, volume = {11}, journal = {Journal of Clinical Medicine}, number = {1}, issn = {2077-0383}, doi = {10.3390/jcm11010057}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-252285}, year = {2021}, abstract = {Background: COVID-19 patients are at high thrombotic risk. The safety and efficacy of different anticoagulation regimens in COVID-19 patients remain unclear. Methods: We searched for randomised controlled trials (RCTs) comparing intermediate- or therapeutic-dose anticoagulation to standard thromboprophylaxis in hospitalised patients with COVID-19 irrespective of disease severity. To assess efficacy and safety, we meta-analysed data for all-cause mortality, clinical status, thrombotic event or death, and major bleedings. Results: Eight RCTs, including 5580 patients, were identified, with two comparing intermediate- and six therapeutic-dose anticoagulation to standard thromboprophylaxis. Intermediate-dose anticoagulation may have little or no effect on any thrombotic event or death (RR 1.03, 95\% CI 0.86-1.24), but may increase major bleedings (RR 1.48, 95\% CI 0.53-4.15) in moderate to severe COVID-19 patients. Therapeutic-dose anticoagulation may decrease any thrombotic event or death in patients with moderate COVID-19 (RR 0.64, 95\% CI 0.38-1.07), but may have little or no effect in patients with severe disease (RR 0.98, 95\% CI 0.86-1.12). The risk of major bleedings may increase independent of disease severity (RR 1.78, 95\% CI 1.15-2.74). Conclusions: Certainty of evidence is still low. Moderately affected COVID-19 patients may benefit from therapeutic-dose anticoagulation, but the risk for bleeding is increased.}, language = {en} } @article{HolzmannLittigStadlerPoppetal.2023, author = {Holzmann-Littig, Christopher and Stadler, David and Popp, Maria and Kranke, Peter and Fichtner, Falk and Schmaderer, Christoph and Renders, Lutz and Braunisch, Matthias Christoph and Assali, Tarek and Platen, Louise and Wijnen-Meijer, Marjo and L{\"u}hnen, Julia and Steckelberg, Anke and Pfadenhauer, Lisa and Haller, Bernhard and Fuetterer, Cornelia and Seeber, Christian and Schaaf, Christian}, title = {Locating medical information during an infodemic: information seeking behavior and strategies of health-care workers in Germany}, series = {Healthcare}, volume = {11}, journal = {Healthcare}, number = {11}, issn = {2227-9032}, doi = {10.3390/healthcare11111602}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-319306}, year = {2023}, abstract = {Background: The COVID-19 pandemic has led to a flood of — often contradictory — evidence. HCWs had to develop strategies to locate information that supported their work. We investigated the information-seeking of different HCW groups in Germany. Methods: In December 2020, we conducted online surveys on COVID-19 information sources, strategies, assigned trustworthiness, and barriers — and in February 2021, on COVID-19 vaccination information sources. Results were analyzed descriptively; group comparisons were performed using χ\(^2\)-tests. Results: For general COVID-19-related medical information (413 participants), non-physicians most often selected official websites (57\%), TV (57\%), and e-mail/newsletters (46\%) as preferred information sources — physicians chose official websites (63\%), e-mail/newsletters (56\%), and professional journals (55\%). Non-physician HCWs used Facebook/YouTube more frequently. The main barriers were insufficient time and access issues. Non-physicians chose abstracts (66\%), videos (45\%), and webinars (40\%) as preferred information strategy; physicians: overviews with algorithms (66\%), abstracts (62\%), webinars (48\%). Information seeking on COVID-19 vaccination (2700 participants) was quite similar, however, with newspapers being more often used by non-physicians (63\%) vs. physician HCWs (70\%). Conclusion: Non-physician HCWs more often consulted public information sources. Employers/institutions should ensure the supply of professional, targeted COVID-19 information for different HCW groups.}, language = {en} } @article{HolzmannLittigFrankSchmadereretal.2022, author = {Holzmann-Littig, Christopher and Frank, Tamara and Schmaderer, Christoph and Braunisch, Matthias C. and Renders, Lutz and Kranke, Peter and Popp, Maria and Seeber, Christian and Fichtner, Falk and Littig, Bianca and Carbajo-Lozoya, Javier and Meerpohl, Joerg J. and Haller, Bernhard and Allwang, Christine}, title = {COVID-19 Vaccines: Fear of side effects among German health care workers}, series = {Vaccines}, volume = {10}, journal = {Vaccines}, number = {5}, issn = {2076-393X}, doi = {10.3390/vaccines10050689}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-270561}, year = {2022}, abstract = {(1) Background: Health care workers (HCWs) play a key role in increasing anti-COVID vaccination rates. Fear of potential side effects is one of the main reasons for vaccine hesitancy. We investigated which side effects are of concern to HCWs and how these are associated with vaccine hesitancy. (2) Methods: Data were collected in an online survey in February 2021 among HCWs from across Germany with 4500 included participants. Free-text comments on previously experienced vaccination side effects, and fear of short- and long-term side effects of the COVID-19 vaccination were categorized and analyzed. (3) Results: Most feared short-term side effects were vaccination reactions, allergic reactions, and limitations in daily life. Most feared long-term side effects were (auto-) immune reactions, neurological side effects, and currently unknown long-term consequences. Concerns about serious vaccination side effects were associated with vaccination refusal. There was a clear association between refusal of COVID-19 vaccination in one's personal environment and fear of side effects. (4) Conclusions: Transparent information about vaccine side effects is needed, especially for HCW. Especially when the participants' acquaintances advised against vaccination, they were significantly more likely to fear side effects. Thus, further education of HCW is necessary to achieve good information transfer in clusters as well.}, language = {en} } @article{HolzmannLittigBraunischKrankeetal.2021, author = {Holzmann-Littig, Christopher and Braunisch, Matthias Christoph and Kranke, Peter and Popp, Maria and Seeber, Christian and Fichtner, Falk and Littig, Bianca and Carbajo-Lozoya, Javier and Allwang, Christine and Frank, Tamara and Meerpohl, Joerg Johannes and Haller, Bernhard and Schmaderer, Christoph}, title = {COVID-19 vaccination acceptance and hesitancy among healthcare workers in germany}, series = {Vaccines}, volume = {9}, journal = {Vaccines}, number = {7}, issn = {2076-393X}, doi = {10.3390/vaccines9070777}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-242627}, year = {2021}, abstract = {Vaccination hesitancy is a threat to herd immunity. Healthcare workers (HCWs) play a key role in promoting Coronavirus disease 2019 (COVID-19) vaccination in the general population. We therefore aimed to provide data on COVID-19 vaccination acceptance/hesitancy among German HCWs. For this exploratory, cross-sectional study, an online survey was conducted in February 2021. The survey included 54 items on demographics; previous vaccination behavior; trust in vaccines, physicians, the pharmaceutical industry and health politics; fear of adverse effects; assumptions regarding the consequences of COVID-19; knowledge about vaccines; and information seeking behavior. Odds ratios with 95\% confidence intervals were calculated and chi-square tests were performed. Four thousand five hundred surveys were analyzed. The overall vaccination acceptance was 91.7\%. The age group ≤20 years showed the lowest vaccination acceptance. Factors associated with vaccination hesitancy were lack of trust in authorities and pharmaceutical companies. Attitudes among acquaintances were associated with vaccination hesitancy too. Participants with vaccination hesitancy more often obtained information about COVID-19 vaccines via messenger services or online video platforms and underperformed in the knowledge test. We found high acceptance amongst German HCWs. Several factors associated with vaccination hesitancy were identified which could be targeted in HCW vaccination campaigns.}, language = {en} } @article{BenKraiemSauerNorwigetal.2021, author = {Ben-Kraiem, Adel and Sauer, Reine-Solange and Norwig, Carla and Popp, Maria and Bettenhausen, Anna-Lena and Atalla, Mariam Sobhy and Brack, Alexander and Blum, Robert and Doppler, Kathrin and Rittner, Heike Lydia}, title = {Selective blood-nerve barrier leakiness with claudin-1 and vessel-associated macrophage loss in diabetic polyneuropathy}, series = {Journal of Molecular Medicine}, volume = {99}, journal = {Journal of Molecular Medicine}, number = {9}, doi = {10.1007/s00109-021-02091-1}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-265237}, pages = {1237-1250}, year = {2021}, abstract = {Diabetic polyneuropathy (DPN) is the most common complication in diabetes and can be painful in up to 26\% of all diabetic patients. Peripheral nerves are shielded by the blood-nerve barrier (BNB) consisting of the perineurium and endoneurial vessels. So far, there are conflicting results regarding the role and function of the BNB in the pathophysiology of DPN. In this study, we analyzed the spatiotemporal tight junction protein profile, barrier permeability, and vessel-associated macrophages in Wistar rats with streptozotocin-induced DPN. In these rats, mechanical hypersensitivity developed after 2 weeks and loss of motor function after 8 weeks, while the BNB and the blood-DRG barrier were leakier for small, but not for large molecules after 8 weeks only. The blood-spinal cord barrier remained sealed throughout the observation period. No gross changes in tight junction protein or cytokine expression were observed in all barriers to blood. However, expression of Cldn1 mRNA in perineurium was specifically downregulated in conjunction with weaker vessel-associated macrophage shielding of the BNB. Our results underline the role of specific tight junction proteins and BNB breakdown in DPN maintenance and differentiate DPN from traumatic nerve injury. Targeting claudins and sealing the BNB could stabilize pain and prevent further nerve damage.}, language = {en} }