Reporting and transparent research practices in sports medicine and orthopaedic clinical trials: a meta-research study

Objectives: Transparent reporting of clinical trials is essential to assess the risk of bias and translate research findings into clinical practice. While existing studies have shown that deficiencies are common, detailed empirical and field-specific data are scarce. Therefore, this study aimed to examine current clinical trial reporting and transparent research practices in sports medicine and orthopaedics. Setting: Exploratory meta-research study on reporting quality and transparent research practices in orthopaedics and sports medicine clinical trials. Participants: The sample included clinical trials published in the top 25% of sports medicine and orthopaedics journals over 9 months. Primary and secondary outcome measures: Two independent reviewers assessed pre-registration, open data and criteria related to scientific rigour, like randomisation, blinding, and sample size calculations, as well as the study sample, and data analysis. Results: The sample included 163 clinical trials from 27 journals. While the majority of trials mentioned rigour criteria, essential details were often missing. Sixty per cent (95% confidence interval (CI) 53% to 68%) of trials reported sample size calculations, but only 32% (95% CI 25% to 39%) justified the expected effect size. Few trials indicated the blinding status of all main stakeholders (4%; 95% CI 1% to 7%). Only 18% (95% CI 12% to 24%) included information on randomisation type, method and concealed allocation. Most trials reported participants' sex/gender (95%; 95% CI 92% to 98%) and information on inclusion and exclusion criteria (78%; 95% CI 72% to 84%). Only 20% (95% CI 14% to 26%) of trials were pre-registered. No trials deposited data in open repositories. Conclusions: These results will aid the sports medicine and orthopaedics community in developing tailored interventions to improve reporting. While authors typically mention blinding, randomisation and other factors, essential details are often missing. Greater acceptance of open science practices, like pre-registration and open data, is needed. As these practices have been widely encouraged, we discuss systemic interventions that may improve clinical trial reporting

Ways to increase equity, diversity and inclusion

The eLife Early-Career Advisory Group (ECAG), an international group of early-career researchers committed to improving research culture, calls for radical changes at eLife and other journals to address racism in the scientific community and to make science more diverse and inclusive.Fil: Mehta, Devang. University of Alberta; CanadáFil: Bediako, Yaw. University Of Ghana; GhanaFil: De Winde, Charlotte M.. Colegio Universitario de Londres; Reino UnidoFil: Ebrahimi, Hedyeh. No especifíca;Fil: Fernández, Florencia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigación en Biomedicina de Buenos Aires - Instituto Partner de la Sociedad Max Planck; ArgentinaFil: Ilangovan, Vinodh. University Aarhus; DinamarcaFil: Paz Quezada, Carolina. Universidad Bernardo O'higgins; ChileFil: Riley, Julia L.. Dalhousie University Halifax; CanadáFil: Saladi, Shyam M.. California Institute of Technology; Estados UnidosFil: Tay, Andy. No especifíca;Fil: Weissgerber, Tracey. No especifíca

Mitigating the impact of conference and travel cancellations on researchers’ futures

The need to protect public health during the current COVID-19 pandemic has necessitated conference cancellations on an unprecedented scale. As the scientific community adapts to new working conditions, it is important to recognize that some of our actions may disproportionately affect early-career researchers and scientists from countries with limited research funding. We encourage all conference organizers, funders and institutions who are able to do so to consider how they can mitigate the unintended consequences of conference and travel cancellations and we provide seven recommendations for how this could be achieved. The proposed solutions may also offer long-term benefits for those who normally cannot attend conferences, and thus lead to a more equitable future for generations of researchers

Recommendations for empowering early career researchers to improve research culture and practice

Early career researchers (ECRs) are important stakeholders leading efforts to catalyze systemic change in research culture and practice. Here, we summarize the outputs from a virtual unconventional conference (unconference), which brought together 54 invited experts from 20 countries with extensive experience in ECR initiatives designed to improve the culture and practice of science. Together, we drafted 2 sets of recommendations for (1) ECRs directly involved in initiatives or activities to change research culture and practice; and (2) stakeholders who wish to support ECRs in these efforts. Importantly, these points apply to ECRs working to promote change on a systemic level, not only those improving aspects of their own work. In both sets of recommendations, we underline the importance of incentivizing and providing time and resources for systems-level science improvement activities, including ECRs in organizational decision-making processes, and working to dismantle structural barriers to participation for marginalized groups. We further highlight obstacles that ECRs face when working to promote reform, as well as proposed solutions and examples of current best practices. The abstract and recommendations for stakeholders are available in Dutch, German, Greek (abstract only), Italian, Japanese, Polish, Portuguese, Spanish, and Serbian.Instituto de Patología VegetalFil: Kent, Brianne A. Simon Fraser University. Department of Psychology; CanadáFil: Holman, Constance. Universitätsmedizin Berlin. BIH QUEST Center for Responsible Research. Berlin Institute of Health at Charité; AlemaniaFil: Amoako, Emmanuella. Cape Coast Teaching Hospital. Department of Paediatrics and Child Health; GhanaFil: Amoako, Emmanuella. University of Cape Coast. School of Medicine. Department of Paediatrics and Child Health; GhanaFil: Antonietti, Alberto. Politecnico di Milano. Department of Electronics, Information and Bioengineering; ItaliaFil: Azam, James M. Stellenbosch University. DSI-NRF Center of Excellence in Epidemiological Modelling and Analysis. Department of Mathematics; SudáfricaFil: Ballhausen, Hanne. Universitätsmedizin Berlin. BIH QUEST Center for Responsible Research. Berlin Institute of Health at Charité; AlemaniaFil: Fil: Ballhausen, Hanne. Universitätsmedizin Berlin. Department of Paediatric Endocrinology and Diabetes, Charité; AlemaniaFil: Bediako, Yaw . University of Ghana. West African Centre for Cell Biology of Infectious Pathogens; GhanaFil: Belasen, Anat M. Cornell University. Society for Conservation Biology. Department of Ecology and Evolutionary Biology; Estados UnidosFil: Carneiro, Clarissa F. D. Federal University of Rio de Janeiro. Institute of Medical Biochemistry Leopoldo de Meis; BrasilFil: Chung Chen, Yen. New York University. Department of Biology; Estados UnidosFil: Debat, Humberto Julio. Instituto Nacional de Tecnología Agropecuaria (INTA). Instituto de Patología Vegetal; ArgentinaFil: Debat, Humberto Julio. Consejo Nacional de Investigaciones Científicas y Técnicas. Unidad de Fitopatología y Modelización Agrícola (UFyMA); ArgentinaFil: Weissgerber, Tracey L. Universitätsmedizin Berlin. BIH QUEST Center for Responsible Research. Berlin Institute of Health at Charité; Alemani

Haptoglobin Phenotype, Preeclampsia Risk and the Efficacy of Vitamin C and E Supplementation to Prevent Preeclampsia in a Racially Diverse Population

Haptoglobin's (Hp) antioxidant and pro-angiogenic properties differ between the 1-1, 2-1, and 2-2 phenotypes. Hp phenotype affects cardiovascular disease risk and treatment response to antioxidant vitamins in some non-pregnant populations. We previously demonstrated that preeclampsia risk was doubled in white Hp 2-1 women, compared to Hp 1-1 women. Our objectives were to determine whether we could reproduce this finding in a larger cohort, and to determine whether Hp phenotype influences lack of efficacy of antioxidant vitamins in preventing preeclampsia and serious complications of pregnancy-associated hypertension (PAH). This is a secondary analysis of a randomized controlled trial in which 10,154 low-risk women received daily vitamin C and E, or placebo, from 9-16 weeks gestation until delivery. Hp phenotype was determined in the study prediction cohort (n = 2,393) and a case-control cohort (703 cases, 1,406 controls). The primary outcome was severe PAH, or mild or severe PAH with elevated liver enzymes, elevated serum creatinine, thrombocytopenia, eclampsia, fetal growth restriction, medically indicated preterm birth or perinatal death. Preeclampsia was a secondary outcome. Odds ratios were estimated by logistic regression. Sampling weights were used to reduce bias from an overrepresentation of women with preeclampsia or the primary outcome. There was no relationship between Hp phenotype and the primary outcome or preeclampsia in Hispanic, white/other or black women. Vitamin supplementation did not reduce the risk of the primary outcome or preeclampsia in women of any phenotype. Supplementation increased preeclampsia risk (odds ratio 3.30; 95% confidence interval 1.61-6.82, p<0.01) in Hispanic Hp 2-2 women. Hp phenotype does not influence preeclampsia risk, or identify a subset of women who may benefit from vitamin C and E supplementation to prevent preeclampsia

Haptoglobin phenotype and abnormal uterine artery Doppler in a racially diverse cohort

The anti-oxidant and proangiogenic protein haptoglobin (Hp) is believed to be important for implantation and pregnancy, although its specific role is not known. The three phenotypes (1-1, 2-1 and 2-2) differ in structure and function. Hp 2-2 is associated with increased vascular stiffness in other populations. We examined whether Hp phenotype is associated with abnormal uterine artery Doppler (UAD) in pregnancy

Partial Deletion of Chromosome 8 β-defensin Cluster Confers Sperm Dysfunction and Infertility in Male Mice

β-defensin peptides are a family of antimicrobial peptides present at mucosal surfaces, with the main site of expression under normal conditions in the male reproductive tract. Although they kill microbes in vitro and interact with immune cells, the precise role of these genes in vivo remains uncertain. We show here that homozygous deletion of a cluster of nine β-defensin genes (DefbΔ9) in the mouse results in male sterility. The sperm derived from the mutants have reduced motility and increased fragility. Epididymal sperm isolated from the cauda should require capacitation to induce the acrosome reaction but sperm from the mutants demonstrate precocious capacitation and increased spontaneous acrosome reaction compared to wild-types but have reduced ability to bind the zona pellucida of oocytes. Ultrastructural examination reveals a defect in microtubule structure of the axoneme with increased disintegration in mutant derived sperm present in the epididymis cauda region, but not in caput region or testes. Consistent with premature acrosome reaction, sperm from mutant animals have significantly increased intracellular calcium content. Thus we demonstrate in vivo that β-defensins are essential for successful sperm maturation, and their disruption leads to alteration in intracellular calcium, inappropriate spontaneous acrosome reaction and profound male infertility

Eleven strategies for making reproducible research and open science training the norm at research institutions

Across disciplines, researchers increasingly recognize that open science and reproducible research practices may accelerate scientific progress by allowing others to reuse research outputs and by promoting rigorous research that is more likely to yield trustworthy results. While initiatives, training programs, and funder policies encourage researchers to adopt reproducible research and open science practices, these practices are uncommon inmanyfields. Researchers need training to integrate these practicesinto their daily work. We organized a virtual brainstorming event, in collaboration with the German Reproducibility Network, to discuss strategies for making reproducible research and open science training the norm at research institutions. Here, weoutline eleven strategies, concentrated in three areas:(1)offering training, (2)adapting research assessment criteria and program requirements, and (3) building communities. We provide a brief overview of each strategy, offer tips for implementation,and provide links to resources. Our goal is toencourage members of the research community to think creatively about the many ways they can contribute and collaborate to build communities,and make reproducible research and open sciencetraining the norm. Researchers may act in their roles as scientists, supervisors, mentors, instructors, and members of curriculum, hiring or evaluation committees. Institutionalleadership and research administration andsupport staff can accelerate progress by implementing change across their institution

Eleven strategies for making reproducible research and open science training the norm at research institutions

Across disciplines, researchers increasingly recognize that open science and reproducible research practices may accelerate scientific progress by allowing others to reuse research outputs and by promoting rigorous research that is more likely to yield trustworthy results. While initiatives, training programs, and funder policies encourage researchers to adopt reproducible research and open science practices, these practices are uncommon inmanyfields. Researchers need training to integrate these practicesinto their daily work. We organized a virtual brainstorming event, in collaboration with the German Reproducibility Network, to discuss strategies for making reproducible research and open science training the norm at research institutions. Here, weoutline eleven strategies, concentrated in three areas:(1)offering training, (2)adapting research assessment criteria and program requirements, and (3) building communities. We provide a brief overview of each strategy, offer tips for implementation,and provide links to resources. Our goal is toencourage members of the research community to think creatively about the many ways they can contribute and collaborate to build communities,and make reproducible research and open sciencetraining the norm. Researchers may act in their roles as scientists, supervisors, mentors, instructors, and members of curriculum, hiring or evaluation committees. Institutionalleadership and research administration andsupport staff can accelerate progress by implementing change across their institution