Dataset Information

Publication rates in animal research. Extent and characteristics of published and non-published animal studies followed up at two German university medical centres.

ABSTRACT: Non-publication and publication bias in animal research is a core topic in current debates on the "reproducibility crisis" and "failure rates in clinical research". To date, however, we lack reliable evidence on the extent of non-publication in animal research. We collected a random and stratified sample (n = 210) from all archived animal study protocols of two major German UMCs (university medical centres) and tracked their results publication. The overall publication rate was 67%. Excluding doctoral theses as results publications, the publication rate decreased to 58%. We did not find substantial differences in publication rates with regard to i) the year of animal study approval, ii) the two UMCs, iii) the animal type (rodents vs. non-rodents), iv) the scope of research (basic vs. preclinical), or v) the discipline of the applicant. Via the most reliable assessment strategy currently available, our study confirms that the non-publication of results from animal studies conducted at UMCs is relatively common. The non-publication of 33% of all animal studies is problematic for the following reasons: A) the primary legitimation of animal research, which is the intended knowledge gain for the wider scientific community, B) the waste of public resources, C) the unnecessary repetition of animal studies, and D) incomplete and potentially biased preclinical evidence for decision making on launching early human trials. Results dissemination should become a professional standard for animal research. Academic institutions and research funders should develop effective policies in this regard.

SUBMITTER: Wieschowski S

PROVIDER: S-EPMC6879110 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publication rates in animal research. Extent and characteristics of published and non-published animal studies followed up at two German university medical centres.

Wieschowski Susanne S Biernot Svenja S Deutsch Susanne S Glage Silke S Bleich André A Tolba René R Strech Daniel D

PloS one 20191126 11

Non-publication and publication bias in animal research is a core topic in current debates on the "reproducibility crisis" and "failure rates in clinical research". To date, however, we lack reliable evidence on the extent of non-publication in animal research. We collected a random and stratified sample (n = 210) from all archived animal study protocols of two major German UMCs (university medical centres) and tracked their results publication. The overall publication rate was 67%. Excluding do ...[more]

PMID: 31770377

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Project description:ObjectivesPublication bias, non-publication, and selective reporting of animal studies limit progress toward the 3Rs (Replacement, Reduction, and Refinement) that guide ethical animal testing, waste public resources, and result in redundant research, which collectively undermine the public's trust in scientific reliability. In this study, we aimed to 1) validate findings from a previous follow-up study by our team that examined the publication rates of animal studies from protocol to publication and 2) identify incentives for improving publication rates in animal research.MethodsThe researchers responsible for the animal proposals (n = 210) from our previous study were contacted as participants for a Web-based survey between October 2019 and April 2020. Question types varied between free text questions, answer options based on a 5-point Likert scale and closed yes/no questions.ResultsIn total, 78 researchers responsible for 101 of 210 animal study proposals participated, yielding a response rate of 48.1%. Results showed that the publication rate increased from 67% in our follow-up study to 70%. According to a 5-point Likert scale (from 1 = "not relevant" to 5 = "extremely relevant"), the most widely accepted suggestions for increasing publication rates were "Publication costs for open access journals are fully covered by funders or universities" (mean 4.02, SD 1.01), "Performance-based allocation of intramural funds for results reporting of animal research not supporting the initial hypothesis (including preprints and repositories)" (mean 3.37, SD 1.05), and "Researchers receive more information from scientific journals that also publish non-significant results" (mean 3.30, SD 1.02).ConclusionWhile the extent of publication and publication practices have been thoroughly investigated for clinical trials, less data is available for animal research to date. Therefore, the study contributes in complementing the picture of publication practice in animal research. Suggestions from our survey may help improve the publication rates of animal studies.

Project description:ObjectivesNon-publication and publication bias are topics of considerable importance to the scientific community. These issues may limit progress toward the 3R principle for animal research, promote waste of public resources, and generate biased interpretations of clinical outcomes. To investigate current publishing practices and to gain some understanding of the extent to which research results are reported, we examined publication rates of research projects that were approved within an internal funding program of the Faculty of Medicine at a university medical center in Germany, which is exemplary for comparable research funding programs for the promotion of young researchers in Germany and Europe.MethodsWe analyzed the complete set (n = 363) of research projects that were supported by an internal funding program between 2004 and 2013. We divided the projects into four different proposal types that included those that required an ethics vote, those that included an animal proposal, those that included both requirements, and those that included neither requirement.ResultsWe found that 65% of the internally funded research projects resulted in at least one peer-reviewed publication; this increased to 73% if other research contributions were considered, including abstracts, book and congress contributions, scientific posters, and presentations. There were no significant differences with respect to publication rates based on (a) the clinic/institute of the applicant, (b) project duration, (c) scope of funding or (d) proposal type.ConclusionTo the best of our knowledge, this is the first study to explore publication rates associated with early-career medical research funding. As >70% of the projects ultimately generated some form of publication, the program was overall effective toward this goal; however, non-publication of research results is still prevalent. Further research will explore the reasons underlying non-publication. We hope to use these findings to develop strategies that encourage publication of research results.

Project description:OBJECTIVES:To identify underlying causes for failure of medical thesis projects and the constantly high drop-out rate in Germany from the supervisors' perspective and to compare the results with the students' perspective. SETTING:Cross-sectional survey. Online questionnaire for survey of medical thesis supervisors among the staff of Charité-Universitätsmedizin Berlin, Germany. Published, earlier longitudinal survey among students for comparison. PARTICIPANTS:1069 thesis supervisors participated. DATA EXTRACTION AND SYNTHESIS:Data are presented using descriptive statistics, and the χ2 test served to compare the results among supervisors with the earlier data from the longitudinal survey of doctoral students. PRIMARY AND SECONDARY OUTCOMES:Not applicable. This survey is an observational study. RESULTS:Of 3653 potential participants, 1069 (29.3%) supervising 3744 doctoral candidates participated in the study. Supervisors considered themselves to be highly motivated and to offer adequate supervision. On the other hand, 87% stated that they did not feel well prepared for thesis supervision. Supervisors gave lack of timeliness of doctoral students and personal differences (p=0.024 and p=0.001) as the main reasons for terminating thesis projects. Doctoral students predominantly mentioned methodological problems and difficult subjects as critical issues (p=0.001 and p<0.001). Specifically, students felt ill prepared for the statistical part of their research-49.5% stated that they never received statistical assistance, whereas 97% of supervisors claimed to help their students with statistical analysis. CONCLUSIONS:The authors found that both thesis supervisors and medical students feel ill prepared for their roles in the process of a medical dissertation. Contradictory reasons for terminating medical thesis projects based on supervisors' and students' self-assessment suggest a lack of communication and true scientific collaboration between supervisors and doctoral students as the major underlying issue that requires resolution.

Project description:ObjectivesThe medical field is facing a clinician-scientist shortage. Medical schools could foster the clinician-scientist workforce by offering students research opportunities. Most medical schools offer elective research programmes. Subsequently, a subset of doctors graduates without any research experience. Mandatory research projects may be more sufficient to develop clinician-scientist, but take more supervision and curricular time. There is limited insight in the scientific outcomes of mandatory research experiences. This study aims to examine publication rates of a mandatory research experience, identify factors associated with publication, and includes postgraduate research engagement.Design and settingProspective follow-up study involving 10 cohorts of medical students' mandatory research projects from Leiden University Medical Center.ParticipantsAll medical students who conducted their research project between 2008 and 2018 (n=2329) were included.Main outcome measurePublication rates were defined as peer-reviewed scientific publications, including research papers, reviews, and published meeting abstracts. Postgraduate research engagement was defined as research participation and dissemination of research at scientific conferences or in journals.ResultsIn total, 644 (27.7%) of all mandatory research experiences resulted in publication, with students mainly as first (n=984, 42.5%) or second author (n=587, 25.3%) and above world average citation impact (mean normalised journal score 1.29, mean normalised citation score 1.23). Students who conducted their research in an academic centre (adjusted OR 2.82; 95% CI 2.10 to 3.77), extended their research (adjusted OR 1.73; 95% CI 1.35 to 2.20), were involved in an excellency track (adjusted OR 2.08; 95% CI 1.44 to 3.01), or conducted clinical (adjusted OR 2.08; 95% CI 1.15 to 3.74) or laboratory (adjusted OR 2.16; 95% CI 1.16 to 4.01) research published their research more often. Later as junior doctors, this group significantly more often disseminate their research results at scientific conferences (adjusted OR 1.89; 95% CI 1.11 to 3.23) or in journals (adjusted OR 1.98; 95% CI 1.14 to 3.43).ConclusionsOur findings suggest that a significant subset of hands-on mandatory research projects with flexible learning pathways result in tangible research output with proper impact and that such successful experiences can be considered as diving board towards a research-oriented career.

Project description:ImportancePublishing study protocols might reduce research waste because of unclear methods or incomplete reporting; on the other hand, there might be few additional benefits of publishing protocols for registered trials that are never completed or published. No study has investigated the proportion of published protocols associated with published results.ObjectiveTo estimate the proportion of published trial protocols for which there are not associated published results.Design, setting, and participantsThis cross-sectional study used stratified random sampling to identify registered clinical trials with protocols published between January 2011 and August 2022 and indexed in PubMed Central. Ongoing studies and those within 1 year of the primary completion date on ClinicalTrials.gov were excluded. Published results were sought from August 2022 to March 2023 by searching ClinicalTrials.gov, emailing authors, and using an automated tool, as well as through incidental discovery.Main outcomes and measuresThe primary outcome was a weighted estimate of the proportion of registered trials with published protocols that also had published main results. The proportion of trials with unpublished results was estimated using a weighted mean.ResultsFrom 1500 citations that were screened, 308 clinical trial protocols were included, and it was found that 87 trials had not published their main results. Most included trials were investigator-initiated evaluations of nonregulated products. When published, results appeared a mean (SD) of 3.4 (2.0) years after protocol publications. With the use of a weighted mean, an estimated 4754 (95% CI, 4296-5226) eligible clinical trial protocols were published and indexed in PubMed Central between 2011 and 2022. In the weighted analysis, 1708 of those protocols (36%; 95% CI, 31%-41%) were not associated with publication of main results. In a sensitivity analysis excluding protocols published after 2019, an estimated 25% (95% CI, 20%-30%) of 3670 (95% CI, 3310-4032) protocol publications were not associated with publication of main results.Conclusions and relevanceThis cross-sectional study of clinical trial protocols published on PubMed Central between 2011 and 2022 suggests that many protocols were not associated with subsequent publication of results. The overall benefits of publishing study protocols might outweigh the research waste caused by unnecessary protocol publications.

Project description:BackgroundMany patients admitted to a hospital are already colonized with multi-drug resistant organisms (MDRO) including third-generation cephalosporin-resistant Enterobacteriaceae (3GCREB). The aim of our study was to determine the prevalence of rectal 3GCREB colonization at admission to a large German university hospital and to estimate infection incidences. In addition, risk factors for 3GCREB colonization were identified.Materials/methodsIn 2014 and 2015, patients were screened for rectal colonization with 3GCREB and filled out a questionnaire on potential risk factors at admission to a non-intensive care unit (non-ICU). All patients were retrospectively monitored for bacterial infections. Descriptive, univariable and multivariable logistic regression analyses were conducted to identify risk factors for 3GCREB colonization at admission.ResultsOf 4,013 patients included, 10.3% (n = 415) were rectally colonized with 3GCREB at admission. Incidence of nosocomial infections was 3.5 (95% CI 2.0-6.1) per 100 patients rectally colonized with 3GCREB compared to 2.3 (95% CI 1.8-3.0, P = 0.213) per 100 3GCREB negative patients. Independent risk factors for 3GCREB colonization were prior colonization / infection with MDRO (OR 2.30, 95% CI 1.59-3.32), prior antimicrobial treatment (OR 1.97, 95% CI 1.59-2.45), male sex (OR 1.38, 95% CI 1.12-1.70), prior travelling outside Europe (OR 2.39, 95% CI 1.77-3.22) and places of residence in the Berlin districts Charlottenburg-Wilmersdorf (OR 1.52, 95% CI 1.06-2.18), Friedrichshain-Kreuzberg (OR 2.32, 95% CI 1.44-3.74) and Mitte (OR 1.73, 95% CI 1.26-2.36).ConclusionsAdmission prevalence of rectal colonization with 3GCREB was high, while infection incidence did not significantly differ between patients rectally colonized or not with 3GCREB at hospital admission. In consequence, hospitals should prioritize improvement of standard precautions including hand hygiene to prevent infections among all patients irrespective of their 3GCREB status at hospital admission.

Project description:Background/aimsInformed clinical guidance and health policy relies on clinicians, policymakers, and guideline developers finding comprehensive clinical evidence and linking registrations and publications of the same clinical trial. To support the finding and linking of trial evidence, the World Health Organization, the International Committee of Medical Journal Editors, and the Consolidated Standards of Reporting Trials ask researchers to provide the trial registration number in their publication and a reference to the publication in the registration. This practice costs researchers minimal effort and makes evidence synthesis more thorough and efficient. Nevertheless, trial evidence appears inadequately linked, and the extent of trial links in Germany remains unquantified. This cross-sectional study aims to evaluate links between registrations and publications across clinical trials conducted by German university medical centers and registered in ClinicalTrials.gov or the German Clinical Trials Registry. Secondary aims are to develop an automated pipeline that can be applied to other cohorts of trial registrations and publications, and to provide stakeholders, from trialists to registries, with guidance to improve trial links.MethodsWe used automated strategies to download and extract data from trial registries, PubMed, and results publications for a cohort of registered, published trials conducted across German university medical centers and completed between 2009 and 2017. We implemented regular expressions to detect and classify publication identifiers in registrations, and trial registration numbers in publication metadata, abstracts, and full-texts.ResultsIn breach of long-standing guidelines, 75% (1,418) of trials failed to reference trial registration numbers in both the abstract and full-text of the journal article in which the results were published. Furthermore, 50% (946) of trial registrations did not contain links to their results publications. Seventeen percent (327) of trials had no links, so that associating registration and publication required manual searching and screening. Overall, trials in ClinicalTrials.gov were better linked than those in the German Clinical Trials Registry; PubMed and registry infrastructures appear to drive this difference. Trial registration numbers were more likely to be transferred to PubMed metadata from abstracts for ClinicalTrials.gov trials than for German Clinical Trials Registry trials. Most (78%, 662/849) ClinicalTrials.gov registrations with a publication link were automatically indexed from PubMed metadata, which is not possible in the German Clinical Trials Registry.ConclusionsGerman university medical centers have not comprehensively linked trial registrations and publications, despite established recommendations. This shortcoming threatens the quality of evidence synthesis and medical practice, and burdens researchers with manually searching and linking trial data. Researchers could easily improve this by copy-and-pasting references between their trial registrations and publications. Other stakeholders could build on this practice, for example, PubMed could capture additional trial registration numbers using automated strategies (like those developed in this study), and the German Clinical Trials Registry could automatically index publications from PubMed.

Dataset Information

Publication rates in animal research. Extent and characteristics of published and non-published animal studies followed up at two German university medical centres.

Publications

Publication rates in animal research. Extent and characteristics of published and non-published animal studies followed up at two German university medical centres.

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