streching

BACKGROUND: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites. METHODS: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use...

BACKGROUND: The results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic. METHODS: Clinical trials for COVID-19 treatment or prevention were identified from the WHO ICTRP database. All interventional trials with a registered completion date ≤ 30 June 2021 were included...

BACKGROUND: Clinical trial registries allow assessment of deviations of published trials from their protocol, which may indicate a considerable risk of bias. However, since entries in many registries can be updated at any time, deviations may go unnoticed. We aimed to assess the frequency of changes to primary outcomes in different historical versions of registry entries, and how often they would go unnoticed if only deviations between published trial reports and the most recent registry entry are assessed...

OBJECTIVE: To provide a systematic overview of bioethical debate on somatic gene therapy as documented in the scientific literature. METHODS: We performed a systematic review of reasons, following Strech and Sofaer (2012) approach, which is a method to systematically identify and classify arguments (reasons) used in the scientific literature. We identified 217 eligible publications retrieved from PubMed, Lilacs, PhilPapers, and Google Scholar. A meta-synthesis was performed to analyse the data...

The interaction of quantum-mechanical systems with a fluctuating thermal environment (bath) is fundamental to molecular mechanics and energy transport/dissipation. Its complete picture requires mode-specific measurements of this interaction and an understanding of its nature. Here, we present a combined experimental and theoretical study providing detailed insights into the coupling between a high-frequency vibrational two-level system and thermally excited terahertz modes. Experimentally, two-dimensional terahertz-infrared-visible spectroscopy reports directly on the coupling between quantum oscillators represented by CH3 streching vibrations in liquid dimethyl sulfoxide and distinct low-frequency modes...

OBJECTIVE: Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting. DESIGN: We used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009-2017, and with a corresponding peer-reviewed results publication...

BACKGROUND: University Medical Centers (UMCs) must do their part for clinical trial transparency by fostering practices such as prospective registration, timely results reporting, and open access. However, research institutions are often unaware of their performance on these practices. Baseline assessments of these practices would highlight where there is room for change and empower UMCs to support improvement. We performed a status quo analysis of established clinical trial registration and reporting practices at German UMCs and developed a dashboard to communicate these baseline assessments with UMC leadership and the wider research community...

INTRODUCTION: Individual treatment attempts (ITAs) are a German concept for the treatment of individual patients by physicians with nonstandard therapeutic approaches. Due to the lack of evidence, ITAs come with a high amount of uncertainty regarding the risk-benefit ratio. Despite the high uncertainty, no prospective review and no systematic retrospective evaluation of ITAs are required in Germany. Our objective was to explore stakeholders' attitudes toward the retrospective evaluation (monitoring) or prospective evaluation (review) of ITAs...

Preregistration of studies is a recognized tool in clinical research to improve the quality and reporting of all gained results. In preclinical research, preregistration could boost the translation of published results into clinical breakthroughs. When studies rely on animal testing or form the basis of clinical trials, maximizing the validity and reliability of research outcomes becomes in addition an ethical obligation. Nevertheless, the implementation of preregistration in animal research is still slow. However, research institutions, funders, and publishers start valuing preregistration, and thereby level the way for its broader acceptance in the future...

The state of open science needs to be monitored to track changes over time and identify areas to create interventions to drive improvements. In order to monitor open science practices, they first need to be well defined and operationalized. To reach consensus on what open science practices to monitor at biomedical research institutions, we conducted a modified 3-round Delphi study. Participants were research administrators, researchers, specialists in dedicated open science roles, and librarians. In rounds 1 and 2, participants completed an online survey evaluating a set of potential open science practices, and for round 3, we hosted two half-day virtual meetings to discuss and vote on items that had not reached consensus...

OBJECTIVES: To evaluate the extent and quality of patient involvement reporting in examples of current practice in health research. DESIGN: Mixed-methods study. We used a targeted search strategy across three cohorts to identify health research publications that reported patient involvement: original research articles published in 2019 in the British Medical Journal (BMJ), articles listed in the Patient-Centered Outcomes Research Institute (PCORI) database (2019), and articles citing the GRIPP2 (Guidance for Reporting Involvement of Patients and Public) reporting checklist for patient involvement or a critical appraisal guideline for user involvement...

BACKGROUND: Empirical research can become relevant for bioethics in at least two ways. First, by informing the development or refinement of ethical recommendations. Second, by evaluating how ethical recommendations are translated into practice. This study aims to investigate the scope and objectives of empirical studies evaluating how ethical recommendations are translated into practice. METHODS: A sample of the latest 400 publications from four bioethics journals was created and screened...

Clinical studies can be more or less transparent in four areas: (a) study registration, (b) results reporting, (c) data/code sharing, and (d) study-related documents. This discussion paper explains the extent to which the EU Regulation 536/2014 (Clinical Trials Regulation - CTR) has already positively impacted the area of results reporting in interventional drug trials and how it can improve the availability of study-related documents for independent research in the future.As this positive trend exists only for the area of results reporting and for the subset of interventional drug trials addressed by the CTR so far, a problematic two-class transparency seems to be developing that distinguishes between clinical studies addressed by the CTR and the other clinical studies...

Effective and efficient privacy risk management (PRM) is a necessary condition to support digitalization in health care and secondary use of patient data in research. To reduce privacy risks, current PRM frameworks are rooted in an approach trying to reduce undesired technical/organizational outcomes such as broken encryption or unintentional data disclosure. Comparing this with risk management in preventive or therapeutic medicine, a key difference becomes apparent: in health-related risk management, medicine focuses on person-specific health outcomes, whereas PRM mostly targets more indirect, technical/organizational outcomes...

INTRODUCTION: Pediatric radial neck fractures are relatively rare elbow injuries commonly seen in children between eight to 12 years of age. Judet type III and Judet type IV radial neck fractures require surgical intervention for optimal functional outcomes. The present study evaluates the functional results of Judet type III and IV radial neck fractures operated at a single center. MATERIALS AND METHODS: This is a retrospective study conducted by using medical records of nine patients who had displaced radial neck fractures (Judet type III and type IV) treated at our institute which is a tertiary trauma care center between January 2012 and December 2021...

AIMS: Research ethics committees and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator's brochures (IBs). Recent studies have indicated that the reporting of preclinical evidence presented in IBs does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, research ethics committee members, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs...

BACKGROUND: Existing evidence indicates that a significant amount of biomedical research involving animals remains unpublished. At the same time, we lack standards for measuring the extent of results reporting in animal research. Publication rates may vary significantly depending on the level of measurement such as an entire animal study, individual experiments within a study, or the number of animals used. METHODS: Drawing on semi-structured interviews with 18 experts and qualitative content analysis, we investigated challenges and opportunities for the measurement of incomplete reporting of biomedical animal research with specific reference to the German situation...

Concerns about research waste have fueled debate about incentivizing individual researchers and research institutions to conduct responsible research. We showed stakeholders a proof-of-principle dashboard with quantitative metrics of responsible research practices at University Medical Centers (UMCs). Our research question was: What are stakeholders' views on a dashboard that displays the adoption of responsible research practices on a UMC-level? We recruited stakeholders (UMC leadership, support staff, funders, and experts in responsible research) to participate in online interviews...

BACKGROUND: The secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions (e.g., in Europe), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities...

BACKGROUND: In light of replication and translational failures, biomedical research practices have recently come under scrutiny. Experts have pointed out that the current incentive structures at research institutions do not sufficiently incentivise researchers to invest in robustness and transparency and instead incentivise them to optimize their fitness in the struggle for publications and grants. This cross-sectional study aimed to describe whether and how relevant policies of university medical centres in Germany support the robust and transparent conduct of research and how prevalent traditional metrics are...