The Peer Review Process: Past, Present, and Future.

The peer review process is a fundamental aspect of modern scientific paper publishing, underpinning essential quality control. First conceptualised in the 1700s, it is an iterative process that aims to elevate scientific literature to the highest standards whilst preventing publication of scientifically unsound, potentially misleading, and even plagiarised information. It is widely accepted that the peer review of scientific papers is an irreplaceable and fundamental aspect of the research process. However, the rapid growth of research and technology has led to a huge increase in the number of publications. This has led to increased pressure on the peer review system. There are several established peer review methodologies, ranging from single and double blind to open and transparent review, but their implementation across journals and research fields varies greatly. Some journals are testing entirely novel approaches (such as collaborative reviews), whilst others are piloting changes to established methods. Given the unprecedented growth in publication numbers, and the ensuing burden on journals, editors, and reviewers, it is imperative to improve the quality and efficiency of the peer review process. Herein we evaluate the peer review process, from its historical origins to current practice and future directions.

Simultaneous Inference of Multiple Binary Endpoints in Biomedical Research: Small Sample Properties of Multiple Marginal Models and a Resampling Approach.

In biomedical research, the simultaneous inference of multiple binary endpoints may be of interest. In such cases, an appropriate multiplicity adjustment is required that controls the family-wise error rate, which represents the probability of making incorrect test decisions. In this paper, we investigate two approaches that perform single-step p $p$ -value adjustments that also take into account the possible correlation between endpoints. A rather novel and flexible approach known as multiple marginal models is considered, which is based on stacking of the parameter estimates of the marginal models and deriving their joint asymptotic distribution. We also investigate a nonparametric vector-based resampling approach, and we compare both approaches with the Bonferroni method by examining the family-wise error rate and power for different parameter settings, including low proportions and small sample sizes. The results show that the resampling-based approach consistently outperforms the other methods in terms of power, while still controlling the family-wise error rate. The multiple marginal models approach, on the other hand, shows a more conservative behavior. However, it offers more versatility in application, allowing for more complex models or straightforward computation of simultaneous confidence intervals. The practical application of the methods is demonstrated using a toxicological dataset from the National Toxicology Program.

Involvement of patients in the research process.

Healthcare research emphasises involvement of patients in the research process, recognizing that this can enhance the relevance, quality, and implementation of research. This article highlights the need for more systematic planning to successfully involve patients in research projects and provides guidance on key aspects that researchers should consider in the planning of involving patients in research. The article accentuates the importance of establishing clear frameworks and guidelines to promote transparency and facilitate implementation.

Development of a research agenda for medical grade footwear in the Netherlands: A multidisciplinary multiphase project to determine the key research questions to advance scientific knowledge in the field.

BACKGROUND: The field of medical grade footwear is dynamic. Originally, a field where individual knowledge, expertise and skills determined the footwear and its outcomes, now becoming a more evidence-based and data-driven field with protocols and systems in place to create appropriate footwear. However, scientific evidence concerning medical grade footwear is still limited. Evidently, all stakeholders, from patients to pedorthists to rehabilitation physicians, will profit from a larger evidence-base in this field. A widely supported research agenda is an essential first step to advance and facilitate new knowledge. METHODS: We formed a multidisciplinary team and followed the methodology from Dutch medical societies for the development of a research agenda on medical grade footwear. This consisted of seven steps: (1) inventory of relevant questions with users and professionals; (2) analyses of responses; (3) analyses of existing knowledge and evidence; (4) formulating research questions; (5) prioritising research questions by users and professionals; (6) finalising the research agenda and (7) implementing the research agenda. RESULTS: In phase 1, 109 participants completed a survey, including 50% pedorthists, 6% rehabilitation physicians and 3% users. Participants provided 228 potential research questions. In phases 2-4, these were condensed to 65 research questions. In phase 5, 152 participants prioritised these 65 research questions, including 50% pedorthists, 13% rehabilitation physicians and 9% users. In phase 6, the final research agenda was created, with 26 research questions, categorised based on the International Classification of Functioning Disability and Health 'process description assistive devices'. In phase 7, an implementation meeting was held with over 50 stakeholders (including users and professionals), resulting in seven applications for research projects based on one or more research questions from the research agenda. CONCLUSIONS: This research agenda structures and guides knowledge development within the field of medical grade footwear in the Netherlands and elsewhere. We expect that this will help to stimulate the field to tackle the research questions prioritised and with that to advance scientific knowledge in this field.

Priorities for Clinical Research in Pediatric Extracorporeal Membrane Oxygenation Anticoagulation From the Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference.

OBJECTIVES: To identify and prioritize research questions for anticoagulation and hemostasis management of neonates and children supported with extracorporeal membrane oxygenation (ECMO) from the Pediatric ECMO Anticoagulation CollaborativE (PEACE) consensus. DATA SOURCES: Systematic review was performed using PubMed, EMBASE, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021, followed by serial consensus conferences of international, interprofessional experts in the management of ECMO for critically ill neonates and children. STUDY SELECTION: The management of ECMO anticoagulation for critically ill neonates and children. DATA EXTRACTION: Within each of the eight subgroups, two authors reviewed all citations independently, with a third independent reviewer resolving any conflicts. DATA SYNTHESIS: Following the systematic review of MEDLINE, EMBASE, and Cochrane Library databases from January 1988 to May 2021, and the consensus process for clinical recommendations and consensus statements, PEACE panel experts constructed research priorities using the Child Health and Nutrition Research Initiative methodology. Twenty research topics were prioritized, falling within five domains (definitions and outcomes, therapeutics, anticoagulant monitoring, protocolized management, and impact of the ECMO circuit and its components on hemostasis). CONCLUSIONS: We present the research priorities identified by the PEACE expert panel after a systematic review of existing evidence informing clinical care of neonates and children managed with ECMO. More research is required within the five identified domains to ultimately inform and improve the care of this vulnerable population.

Hasty generalizations and generics in medical research: A systematic review.

It is unknown to what extent medical researchers generalize study findings beyond their samples when their sample size, sample diversity, or knowledge of conditions that support external validity do not warrant it. It is also unknown to what extent medical researchers describe their results with precise quantifications or unquantified generalizations, i.e., generics, that can obscure variations between individuals. We therefore systematically reviewed all prospective studies (n = 533) published in the top four highest ranking medical journals, Lancet, New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and the British Medical Journal (BMJ), from January 2022 to May 2023. We additionally reviewed all NEJM Journal Watch clinical research summaries (n = 143) published during the same time. Of all research articles reporting prospective studies, 52.5% included generalizations beyond specific national study populations, with the numbers of articles with generics varying significantly between journals (JAMA = 12%; Lancet = 77%) (p < 0.001, V = 0.48). There was no evidence that articles containing broader generalizations or generics were correlated with larger or more nationally diverse samples. Moreover, only 10.2% of articles with generalizations beyond specific national populations reported external validity strengthening factors that could potentially support such extrapolations. There was no evidence that original research articles and NEJM Journal Watch summaries intended for practitioners differed in their use of broad generalizations, including generics. Finally, from the journal with the highest citation impact, articles containing broader conclusions were correlated with more citations. Since there was no evidence that studies with generalizations beyond specific national study populations or with generics were associated with larger, more nationally diverse samples, or with reports of population similarity that may permit extensions of conclusions, our findings suggest that the generalizations in many articles were insufficiently supported. Caution against overly broad generalizations in medical research is warranted.

A bibliometric analysis from 2013 to 2023 reveals research hotspots and trends in the connection between sport and regenerative medicine.

The field of regenerative medicine for sports injuries has grown significantly in the 21st century. This study attempted to provide an overview of the current state of research and key findings regarding the relationship between sport and regenerative medicine in general, identifying trends and hotspots in research topics. We gathered the literature from the Web of Science (WOS) database covering the last 10 years (2013-2023) pertaining to regenerative medicine for sporter and applied Citespace to assess the knowledge mapping. The findings demonstrated that there were 572, with a faster increase after 2018. The country, institution, and author with the most publications are the USA, Harvard University, and Maffulli Nicola. In addition, the most co-cited reference is J Acad Nutr Diet (2016) (199). Adipose tissue, high tibial osteotomy, and bone marrow are the hot spots in this field in the next few years.

Global trends and frontiers of research on Kümmell's disease: A bibliometric analysis.

The prevalence of Kümmell's disease (KD) has been increasing due to the aging population and the rise of osteoporotic vertebral compressibility fractures. As a result, there has been a growing concern about this condition. Despite the rapid advancements in its related research fields, the current research status and hotspot analysis of KD remain unclear. Therefore, our goal was to identify and analyze the global research trends on KD using bibliometric tools. All KD data were obtained from the Web of Science Core Collection. The information of research field was collected, including title, author, institutions, journals, countries, references, total citations, and years of publication for further analysis. From 1900 to 2022, a total of 195 articles and 1973 references have been published in this field, originating from 27 countries/regions and 90 journals, with China leading the contributions. The most significant institutional and author contributions come from Soochow University and Kim, HS, respectively. The journal with the highest number of published research and total citation frequency is Spine. The latest research focuses in this field include "risk factor," "osteoporotic vertebral compression fracture," "pedicle screw fixation," "percutaneous vertebroplasty," and "bone cement," and should be closely monitored. Additionally, we have conducted a comprehensive analysis of the 50 most-cited articles in KD, providing a valuable list of articles to guide clinical decision-making and future research for clinicians and researchers. In recent years, there has been a significant increase in scientific research on KD. Future research in KD is likely to focus on surgical treatment, risk factors, and complications.

The Development of Principles for Patient and Public Involvement (PPI) in Preclinical Spinal Cord Research: A Modified Delphi Study.

INTRODUCTION: There is currently limited guidance for researchers on Patient and Public Involvement (PPI) for preclinical spinal cord research, leading to uncertainty about design and implementation. This study aimed to develop evidence-informed principles to support preclinical spinal cord researchers to incorporate PPI into their research. METHODS: This study used a modified Delphi method with the aim of establishing consensus on a set of principles for PPI in spinal cord research. Thirty-eight stakeholders including researchers, clinicians and people living with spinal cord injury took part in the expert panel. Participants were asked to rate their agreement with a series of statements relating to PPI in preclinical spinal cord research over two rounds. As part of Round 2, they were also asked to rate statements as essential or desirable. RESULTS: Thirty-eight statements were included in Round 1, after which five statements were amended and two additional statements were added. After Round 2, consensus (> 75% agreement) was reached for a total of 27 principles, with 13 rated as essential and 14 rated as desirable. The principles with highest agreement related to diversity in representation among PPI contributors, clarity of the purpose of PPI and effective communication. CONCLUSION: This research developed a previously unavailable set of evidence-informed principles to inform PPI in preclinical spinal cord research. These principles provide guidance for researchers seeking to conduct PPI in preclinical spinal cord research and may also inform PPI in other preclinical disciplines. PATIENT AND PUBLIC INVOLVEMENT STATEMENT: This study was conducted as part of a project aiming to develop PPI in preclinical spinal cord injury research associated with an ongoing research collaboration funded by the Irish Rugby Football Union Charitable Trust (IRFU CT) and the Science Foundation Ireland Centre for Advanced Materials and BioEngineering Research (SFI AMBER), with research conducted by the Tissue Engineering Research Group (TERG) at the RCSI University of Medicine and Health Sciences. The project aims to develop an advanced biomaterials platform for spinal cord repair and includes a PPI Advisory Panel comprising researchers, clinicians and seriously injured rugby players to oversee the work of the project. PPI is included in this study through the involvement of members of the PPI Advisory Panel in the conceptualisation of this research, review of findings, identification of key points for discussion and preparation of the study manuscript as co-authors.

Improving laboratory animal genetic reporting: LAG-R guidelines.

The biomedical research community addresses reproducibility challenges in animal studies through standardized nomenclature, improved experimental design, transparent reporting, data sharing, and centralized repositories. The ARRIVE guidelines outline documentation standards for laboratory animals in experiments, but genetic information is often incomplete. To remedy this, we propose the Laboratory Animal Genetic Reporting (LAG-R) framework. LAG-R aims to document animals' genetic makeup in scientific publications, providing essential details for replication and appropriate model use. While verifying complete genetic compositions may be impractical, better reporting and validation efforts enhance reliability of research. LAG-R standardization will bolster reproducibility, peer review, and overall scientific rigor.

Sepsis Research Using Omics Technology in the European Union and the United Kingdom: Maps, Trends, and Future Implications.

High-throughput omics technologies have become valuable tools for systems science research and clinical management of sepsis. This article analyzes sepsis research using omics technologies in the European Union (EU) and the United Kingdom from 1990 to May 2023 using bibliometric data from the Web of Science database. Using VOSviewer for network analysis, we examined the distribution patterns, funding characteristics, and collaborations among the states, noting trends of convergence and divergence. The analysis included 2078 articles, revealing an increasing rate of publications on sepsis research using omics approaches. The United Kingdom's research output is notably high, contributing 28.3% of the total research from the EU and United Kingdom combined. Germany, France, the Netherlands, and Italy together account for 56.9% of the publications from the EU member states. The United States is the leading international collaborator, particularly with the United Kingdom, followed by Germany and France. The EU-15 countries have significantly more publication outputs in this domain with growing but limited inclusion of the newer members of the EU. We suggest that the role of EU member states and the United Kingdom in sepsis research using omics technologies can be advanced by facilitating high-value, technology-driven health research, fostering collaboration, convergence, and equity in global health and biomedical research.

Factors influencing research productivity among Syrian medical professionals amidst conflict: a case-control study.

BACKGROUND: Medical research productivity is globally increasing, with a lagging progress in third-world countries due to significant challenges, including inadequate training and brain drain. Syria had been showing a slow upward trend until the war broke out and severely hindered academic growth and productivity. A deeper understanding of the factors influencing research productivity in this context are fundamental to guide educational policies and resource allocation. Previous cross-sectional studies that evaluated the perspectives of Syrian academics on the issue were limited by the small sample size of published healthcare workers, making it difficult to identify the factors that enabled them to pursue research. METHODS: To address this challenge, we employed a case-control design. We isolated published early-career Syrian healthcare workers and compared their characteristics and perceptions to unpublished matched controls. Authors in the fields of medicine, dentistry, and pharmacy affiliated with any Syrian University were identified through an extensive search of PubMed and Google Scholar.These authors were invited to complete a questionnaire that covered participants' research contributions, alongside their self-assessed knowledge, attitudes, and barriers towards research. The questionnaire was publicly published to recruit an equal sample of matching controls, with half consisting of unpublished researchers and the other half of participants without prior research contributions. RESULTS: Six-hundred-sixteen participants were recruited. Their knowledge, attitudes, and perceived barriers explained 46% and 34% of the variability in research involvement and publication, respectively (P < 0.001). Getting involved in and publishing research studies associated with higher research-related knowledge and attitudes (P < 0.001). Respondents' assessment of research-related barriers and their academic scores did not differ between cases and controls. Superior research-related knowledge and attitudes were associated with male gender, higher English competency, and better internet connectivity. Meanwhile, extracurricular training and mentors' support were associated with more positive research-related attitudes and less perceived barriers. CONCLUSIONS: Research productivity of medical professionals in Syria exhibits a positive correlation with their knowledge and favorable attitudes towards medical research. Noteworthy, the demographic variations are linked to disparities in research-related knowledge and motivation. In conclusion, these results suggest a potential avenue for enhancement through concentrated efforts on improving extracurricular training interventions and mentors' support.