GRADE Concept Paper 9: Rationale and process for creating a GRADE Ontology.

Context: As the rate of research production accelerates, the ability to efficiently and unambiguously communicate judgements relating to the synthesis, evaluation, and use of scientific information becomes paramount.

Perspective: Scientific information can be viewed as a "layered infrastructure" of data, evidence, knowledge, and use. The GRADE approach serves as a de facto data standard in this infrastructure, reducing ambiguity in claims to knowledge (in the form of judgements of certainty in the evidence when answering research questions) and level of commitment to possible solutions to problems (in the form of strength of recommendations for interventions).

Reporting Guideline for Chatbot Health Advice Studies: The CHART Statement.

Importance: The rise in chatbot health advice (CHA) studies is accompanied by heterogeneity in reporting standards, impacting their interpretability.

Objective: To provide reporting recommendations for studies evaluating the performance of generative artificial intelligence (AI)-driven chatbots when summarizing clinical evidence and providing health advice.

Design, Setting, And Participants: CHART was developed in several phases after performing a comprehensive systematic review to identify variation in the conduct, reporting, and methodology in CHA studies.

Discrepancies Between Recommendations in Evidence-Based Guidelines for the Management of Obesity in Adolescents and Adults: An Evidence Map.

Background/aim: The aim of this evidence map is to provide a systematic overview of evidence-based guidelines for the management of obesity and to highlight discrepancies between recommendations for the pediatric and adult populations. Knowing about these discrepancies may be relevant during the transition from pediatrics to adult healthcare to enable a structured, successful transfer.

Methods: We used two already existing guideline synopses of the Institute for Quality and Efficiency in Health Care as a basis and additionally searched Embase and Medline as well as guideline portals for creating a systematic overview of evidence-based pediatric and adult guidelines on obesity management.

[User experience with plain language summaries of psychological systematic reviews with meta-analysis ("KLARpsy" texts) - A qualitative study using the think aloud method].

Background: Science communication can support informed decision-making. As part of the "PLan Psy" project, a guideline for producing plain language summaries of systematic reviews with meta-analysis on psychological topics ("KLARpsy" texts), was developed. This study aims to investigate the similarities and differences in the user experience with "KLARpsy texts" between laypersons and professionals (science communicators and psychologists).

The Effectiveness of a Physician-Led Web Portal on Back Pain: A Cluster Randomized Controlled Trial.

Background: It is important for patients with back pain to be well-informed. The well-informed patient is better prepared for selfmanagement and for joint decision-making with the physician. This is why we developed tala-med, a web portal providing up-to-date, evidence-based, independent information on back pain.

Large language models for conducting systematic reviews: on the rise, but not yet ready for use-a scoping review.

Background And Objectives: Machine learning promises versatile help in the creation of systematic reviews (SRs). Recently, further developments in the form of large language models (LLMs) and their application in SR conduct attracted attention. We aimed at providing an overview of LLM applications in SR conduct in health research.

Relative Efficacy, Effectiveness and Safety of Newer and/or Enhanced Seasonal Influenza Vaccines for the Prevention of Laboratory-Confirmed Influenza in Individuals Aged 18 years and Over: Update of a Systematic Review.

We performed an update (last search: 24 July 2023) of a systematic review on relative efficacy/effectiveness (rVE) and safety of newer/enhanced seasonal influenza vaccines in comparison with standard influenza vaccine or in head-to-head comparison. Eligible studies investigated adults aged ≥ 18 years, analysed the MF59-adjuvanted or high-dose or cell-based or recombinant or mRNA-based influenza vaccine and reported rVE or safety in randomised controlled trials (RCT) or non-randomised studies of interventions (NRSI). Of 1561 new entries identified, 17 studies were included.

Non-vitamin K antagonist oral anticoagulants (NOACs) after transcatheter aortic valve replacement (TAVR): a network meta-analysis.

Background: Balancing the risk of thromboembolism and bleeding after transcatheter aortic valve replacement (TAVR) remains clinically challenging. Questions regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) after TAVR still need to be definitively answered.

Objectives: To evaluate the efficacy and safety of NOACs after TAVR in individuals with and without indication for anticoagulation.

[Prioritization of research questions in health crises-presentation of a concept developed during the COVID-19 pandemic].

In acute crises such as the COVID-19 pandemic, scientific questions need to be addressed quickly in order to protect the health of the population and to maintain the function of the healthcare system. The prevailing urgency and the large number of issues to be addressed, combined with the limitation of time, personnel, or monetary resources make prioritization indispensable. In the COVID-19 Evidence Ecosystem (CEOsys) project initiated by the University Medicine Network (NUM), a procedure for the rapid prioritization of questions was used specifically for evidence syntheses and clinical guideline recommendations, which was further developed in the follow-up project PREparedness and Pandemic Response in Germany (PREPARED).

Association between substituting macronutrients and all-cause mortality: a network meta-analysis of prospective observational studies.

Background: Suboptimal diet quality is a key risk factor for premature death. Assuming relatively stable energy intake among individuals, changes in nutrient intakes occur by exchanging different nutrients. Therefore we aimed to examine the association of isocaloric substitution of dietary (macro)nutrients with all-cause mortality using network meta-analysis (NMA).

Robot-assisted versus conventional laparoscopic surgery for rectal cancer.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of robot-assisted surgery for rectal cancer resection.

Informing pandemic management in Germany with trustworthy living evidence syntheses and guideline development: lessons learned from the COVID-19 evidence ecosystem.

Objectives: We present the 'COVID-19 evidence ecosystem' (CEOsys) as a German network to inform pandemic management and to support clinical and public health decision-making. We discuss challenges faced when organizing the ecosystem and derive lessons learned for similar networks acting during pandemics or health-related crises.

Study Design And Setting: Bringing together 18 university hospitals and additional institutions, CEOsys key activities included research prioritization, conducting living systematic reviews (LSRs), supporting evidence-based (living) guidelines, knowledge translation (KT), detecting research gaps, and deriving recommendations, backed by technical infrastructure and capacity building.

Pharmacological interventions for preventing upper gastrointestinal bleeding in people admitted to intensive care units: a network meta-analysis.

Objectives: To assess the efficacy and safety of pharmacological interventions for preventing upper gastrointestinal (GI) bleeding in people admitted to intensive care units (ICUs).

Design And Setting: Systematic review and frequentist network meta-analysis using standard methodological procedures as recommended by Cochrane for screening of records, data extraction and analysis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence.

Accuracy of Event Rate and Effect Size Estimation in Major Cardiovascular Trials: A Systematic Review.

Importance: For the design of a randomized clinical trial (RCT), estimation of the expected event rate and effect size of an intervention is needed to calculate the sample size. Overestimation may lead to an underpowered trial.

Objective: To evaluate the accuracy of published estimates of event rate and effect size in contemporary cardiovascular RCTs.

Needs and feasibility of living systematic reviews (LSRs): Experience from LSRs on COVID-19 vaccine effectiveness.

During 2021 and 2023, a team of researchers at the Robert Koch Institute (RKI) and partnering institutions conducted two living systematic reviews (LSRs) on the effectiveness of COVID-19 vaccines in different age groups to inform recommendations of the Standing Committee on Vaccination in Germany (Ständige Impfkommission, STIKO). Based on our experience from the realization of these LSRs, we developed certain criteria to assess the needs and feasibility of conducting LSRs. Combining these with previously established criteria, we developed the following set to inform future planning of LSRs for STIKO: Needs criterion (N)1: Relevance of the research question, N2: Certainty of evidence (CoE) at baseline; N3: Expected need for Population-Intervention-Comparator-Outcome (PICO) adaptations; N4: Expected new evidence over time; N5: Expected impact of new evidence on CoE; Feasibility criterion (F)1: Availability of sufficient human resources; F2: Feasibility of timely dissemination of the results to inform decision-making.

[Development of criteria for the prospective assessment of the need for updating guideline recommendations: The AGIL criteria].

Background: Evidence-based guideline and vaccination recommendations should continuously be updated to appropriately support health care decisions. However, resources for updating guidelines are often limited. The aim of this project was to develop a list of criteria for the prospective assessment of the need for updating individual guideline or vaccination recommendations, which can be applied from the time a guideline or guideline update is finalised.

Musical and vocal interventions to improve neurodevelopmental outcomes for preterm infants.

Background: Preterm birth interferes with brain maturation, and subsequent clinical events and interventions may have additional deleterious effects. Music as therapy is offered increasingly in neonatal intensive care units aiming to improve health outcomes and quality of life for both preterm infants and the well-being of their parents. Systematic reviews of mixed methodological quality have demonstrated ambiguous results for the efficacy of various types of auditory stimulation of preterm infants.