BMJ Open SciencePub Date : 2024-08-07eCollection Date: 2022-01-01DOI: 10.1136/bmjos-2021-100231corr1
{"title":"Correction: Preclinical safety study of nacre powder in an intraosseous sheep model.","authors":"","doi":"10.1136/bmjos-2021-100231corr1","DOIUrl":"https://doi.org/10.1136/bmjos-2021-100231corr1","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1136/bmjos-2021-100231.].</p>","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":"6 1","pages":"e100231corr1"},"PeriodicalIF":0.0,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11412327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142280437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-10-17eCollection Date: 2022-01-01DOI: 10.1136/bmjos-2022-100276
Brian J Slattery, Sophie Sabherwal, William T O'Connor
{"title":"Protocol for a systematic review of the validity of animal models of polydipsia with a basis in schizophrenia aetiology.","authors":"Brian J Slattery, Sophie Sabherwal, William T O'Connor","doi":"10.1136/bmjos-2022-100276","DOIUrl":"https://doi.org/10.1136/bmjos-2022-100276","url":null,"abstract":"Objective Primary polydipsia most commonly affects those with schizophrenia. The pathophysiology of this occurrence is not established. The aim of this systematic review is to critically assess the internal and external validity of the preclinical animal models available. Search strategy PubMed and Embase will be searched systematically to identify all relevant animal studies that describe polydipsia induction with a basis in schizophrenia aetiology. The SYRCLE (SYstematic Review Center for Laboratory animal Experimentation) search filters to identify all animal studies in both databases will be used. All studies published up to the date of the search will be considered. Screening and annotation Two independent reviewers will screen the retrieved studies for eligibility based on (1) title and abstract and (2) full text. Disagreements between researchers will be resolved by discussion and referral back to the predefined eligibility criteria with involvement of a third researcher if required.","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":"e100276"},"PeriodicalIF":0.0,"publicationDate":"2022-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40469585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Preclinical safety study of nacre powder in an intraosseous sheep model.","authors":"Donata Iandolo, Norbert Laroche, Dung Kim Nguyen, Miriam Normand, Christophe Met, Ganggang Zhang, Laurence Vico, Didier Mainard, Marthe Rousseau","doi":"10.1136/bmjos-2021-100231","DOIUrl":"10.1136/bmjos-2021-100231","url":null,"abstract":"<p><strong>Objectives: </strong>The purpose of this preclinical study was to evaluate the safety, the local tissue effects and bone healing performance (osteoconduction, osseointegration) of nacre powder in a sheep intraosseous implantation model. This represents the first preclinical study to assess nacre safety and efficacy in supporting new bone formation in accordance with the ISO 10993 standard for biomedical devices.</p><p><strong>Methods: </strong>The local tissue effects and the material performance were evaluated 8 weeks after implantation by qualitative macroscopic observation and qualitative as well as semiquantitative microscopic analyses of the bone sites. Histopathological characterisations were run to assess local tissue effects. In addition, microarchitectural, histomorphometric and histological characterisations were used to evaluate the effects of the implanted material.</p><p><strong>Results: </strong>Nacre powder was shown to cause a moderate inflammatory response in the site where it was implanted compared with the sites left empty. The biomaterial implanted within the generated defects was almost entirely degraded over the investigated time span and resulted in the formation of new bone with a seamless connection with the surrounding tissue. On the contrary, in the empty defects, the formation of a thick compact band of sclerotic bone was observed by both microarchitectural and histological characterisation.</p><p><strong>Conclusions: </strong>Nacre powder was confirmed to be a safe biomaterial for bone regeneration applications in vivo, while supporting bone formation.</p>","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":"e100231"},"PeriodicalIF":0.0,"publicationDate":"2022-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40469587","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-09-05eCollection Date: 2022-01-01DOI: 10.1136/bmjos-2022-100280
Felix Gantenbein, Tim Buchholz, Kimberley Elaine Wever, Merel Ritskes Hoitinga, Stephan Zeiter, Petra Seebeck
{"title":"Protocol for a systematic review of good surgical practice guidelines for experimental rodent surgery.","authors":"Felix Gantenbein, Tim Buchholz, Kimberley Elaine Wever, Merel Ritskes Hoitinga, Stephan Zeiter, Petra Seebeck","doi":"10.1136/bmjos-2022-100280","DOIUrl":"https://doi.org/10.1136/bmjos-2022-100280","url":null,"abstract":"<p><strong>Objective: </strong>Surgery is an integral part of many experimental studies. Aseptic and minimal invasive surgical technique and optimal perioperative and post-operative care are prerequisites to achieve surgical success and best possible animal welfare outcomes. Good surgical practice cannot only improve the animal's postoperative recovery, but also study outcome and validity. There seems to be a lack of implementation of good surgical practice during rodent surgery. The aim of this systematic review is to identify, critically evaluate and compare the currently recommended standards and underlying guidelines for rodent surgery-and finally to compile a comprehensive guideline of good surgical practice for rodent surgery.</p><p><strong>Search strategy: </strong>PubMed, Embase and Web of Science were searched to identify guidelines published in peer-reviewed journals. To identify grey literature and unpublished guidelines, we will perform a Google search for published guidelines and search laboratory animal sciences books for relevant book chapters. Additionally, we will conduct a survey among animal researchers enquiring about the guidelines they use.</p><p><strong>Screening and study selection: </strong>For publications retrieved by the systematic search, unique references are screened by two reviewers, first for eligibility based on title and abstract and subsequently for final inclusion based on full text. Eligibility of books is based on title and content, final inclusion based on chapter full text. Guidelines are either retrieved by Google searches or a survey. Google searches will be conducted by at least four of the authors. Thereafter, guidelines will be screened by two of the authors.</p><p><strong>Data extraction and synthesis: </strong>We will extract data from publications, book chapters and guidelines. Based on the extracted data, we will perform a descriptive synthesis of the bibliographical details, guideline development and endorsement, and the prevalence of individual recommendations, including subgroup analysis of the guidance per continent or country and differences between peer-reviewed versus non-peer-reviewed guidance.</p>","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":"e100280"},"PeriodicalIF":0.0,"publicationDate":"2022-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644723/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40469142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Genome-wide DNA methylation in an animal model and human studies of schizophrenia: a protocol for a meta-analysis.","authors":"Thabo Magwai, Fredrick Otieno Oginga, Bonginkosi Chiliza, Thabisile Mpofana, Khethelo Richman Xulu","doi":"10.1136/bmjos-2021-100264","DOIUrl":"https://doi.org/10.1136/bmjos-2021-100264","url":null,"abstract":"<p><strong>Introduction and objective: </strong>Neuropsychiatric disorders like schizophrenia are heterogeneous in that they occur because of the interaction of factors. These factors include but are not limited to genetic, epigenetic, neurobiological and environmental factors. Methylation of DNA, like other erpigenetic modifications, is risk factors for neuropsychiatric disorders. Candidate gene approach projects have produced contradictory results to find candidate gene methylation. The current genome-wide studies have limitations.</p><p><strong>Search strategy: </strong>An exhaustive search strategy was designed to recover studies on genome-wide DNA methylation in schizophrenia patients or schizophrenia rat models. The Medline (PubMed), SCOPUS and Web of Science, databases were searched, giving 4077 references in total.</p><p><strong>Screening and annotation: </strong>Studies will undergo two phases of screening, title and abstract screening and article screening, for inclusion by two reviewers. A third reviewer will resolve any disagreements in the article screening phase. Data will be collected using the Systematic Review Facility (http://syrf.org.uk/) tool. All included studies will undergo study quality and risk of bias assessment.</p><p><strong>Data management and reporting: </strong>Data will be extracted and used to calculate effect sizes. For the purpose of this meta-analysis, a random effects model will be used to combine effect sizes. Heterogeneity will be assessed, and the sources identified. A risk-of-bias assessment will be carried out to assess the quality of the studies. An assessment of publication bias will also be carried out.</p><p><strong>Ethics and dissemination: </strong>No ethical approval is required as there are no participants in the study. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines and disseminate the findings through publication and conference presentation.</p><p><strong>Prospero registration number: </strong>CRD42021283159.</p>","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":"e100264"},"PeriodicalIF":0.0,"publicationDate":"2022-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40469586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-06-01eCollection Date: 2022-01-01DOI: 10.1136/bmjos-2021-100272
Timo Sander, Joly Ghanawi, Emma Wilson, Sajjad Muhammad, Malcolm Macleod, Ulf Dietrich Kahlert
{"title":"Meta-analysis on reporting practices as a source of heterogeneity in in vitro cancer research.","authors":"Timo Sander, Joly Ghanawi, Emma Wilson, Sajjad Muhammad, Malcolm Macleod, Ulf Dietrich Kahlert","doi":"10.1136/bmjos-2021-100272","DOIUrl":"10.1136/bmjos-2021-100272","url":null,"abstract":"<p><strong>Objectives: </strong>Heterogeneity of results of exact same research experiments oppose a significant socioeconomic burden. Insufficient methodological reporting is likely to be one of the contributors to results heterogeneity; however, little knowledge on reporting habits of in vitro cancer research and their effects on results reproducibility is available. Exemplified by a commonly performed in vitro assay, we aim to fill this knowledge gap and to derive recommendations necessary for reproducible, robust and translational preclinical science.</p><p><strong>Methods: </strong>Here, we use systematic review to describe reporting practices in in vitro glioblastoma research using the Uppsala-87 Malignant Glioma (U-87 MG) cell line and perform multilevel random-effects meta-analysis followed by meta-regression to explore sources of heterogeneity within that literature, and any associations between reporting characteristics and reported findings. Literature that includes experiments measuring the effect of temozolomide on the viability of U-87 MG cells is searched on three databases (Embase, PubMed and Web of Science).</p><p><strong>Results: </strong>In 137 identified articles, the methodological reporting is incomplete, for example, medium glucose level and cell density are reported in only 21.2% and 16.8% of the articles. After adjustments for different drug concentrations and treatment durations, the results heterogeneity across the studies (I<sup>2</sup>=68.5%) is concerningly large. Differences in culture medium glucose level are a driver of this heterogeneity. However, infrequent reporting of most experimental parameters limits the analysis of reproducibility moderating parameters.</p><p><strong>Conclusions: </strong>Our results further support the ongoing efforts of establishing consensus reporting practices to elevate durability of results. By doing so, this work can raise awareness of how stricter reporting may help to improve the frequency of successful translation of preclinical results into human application. The authors received no specific funding for this work. A preregistered protocol is available at the Open Science Framework (https://osf.io/9k3dq).</p>","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":"e100272"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9171230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40041593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-04-01DOI: 10.1136/bmjos-2021-100268
J. Belien, A. Kip, M. Swertz
{"title":"Road to FAIR genomes: a gap analysis of NGS data generation and sharing in the Netherlands","authors":"J. Belien, A. Kip, M. Swertz","doi":"10.1136/bmjos-2021-100268","DOIUrl":"https://doi.org/10.1136/bmjos-2021-100268","url":null,"abstract":"Objective This study investigates current standards and operational gaps in the management and sharing of next generation sequencing (NGS) data within the healthcare and research setting and according to Findable, Accessible, Interoperable and Reusable (FAIR) principles. Methods The analysis was performed as the basis from which to bridge identified gaps and develop widely accepted working standards that ensure optimal reusability of genomic data in healthcare and research settings in the Netherlands. This work is part of the ‘Rational Pharmacotherapy Program’ led by ZonMw, The Netherlands Organisation for Health Research and Development, which aims to promote the efficient implementation of NGS and personalised medicine within Dutch healthcare, with an initial focus on oncology and rare diseases. Results Based on this analysis and as part of this programme, a consortium was formed to develop an instruction manual for FAIR genomic data in clinical care and research based on an inventory of commonly used workflows and standards in the (inter)national field of genome analysis. Conclusions The gap analysis presented and discussed in this paper represents the starting point for this inventory and is a possible contribution from the Netherlands to the European 1+ Million Genomes Initiative. This paper addresses the topics of data generation, data quality, (meta)data standards, data storage and archiving and data integration and exchange.","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42267168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-03-01DOI: 10.1136/bmjos-2021-100219
A. A. M. Russell, B. Sutherland, Lila M Landowski, Malcolm R Macleod, D. Howells
{"title":"What has preclinical systematic review ever done for us?","authors":"A. A. M. Russell, B. Sutherland, Lila M Landowski, Malcolm R Macleod, D. Howells","doi":"10.1136/bmjos-2021-100219","DOIUrl":"https://doi.org/10.1136/bmjos-2021-100219","url":null,"abstract":"Systematic review and meta-analysis are a gift to the modern researcher, delivering a crystallised understanding of the existing research data in any given space. This can include whether candidate drugs are likely to work or not and which are better than others, whether our models of disease have predictive value and how this might be improved and also how these all interact with disease pathophysiology. Grappling with the literature needed for such analyses is becoming increasingly difficult as the number of publications grows. However, narrowing the focus of a review to reduce workload runs the risk of diminishing the generalisability of conclusions drawn from such increasingly specific analyses. Moreover, at the same time as we gain greater insight into our topic, we also discover more about the flaws that undermine much scientific research. Systematic review and meta-analysis have also shown that the quality of much preclinical research is inadequate. Systematic review has helped reveal the extent of selection bias, performance bias, detection bias, attrition bias and low statistical power, raising questions about the validity of many preclinical research studies. This is perhaps the greatest virtue of systematic review and meta-analysis, the knowledge generated ultimately helps shed light on the limitations of existing research practice, and in doing so, helps bring reform and rigour to research across the sciences. In this commentary, we explore the lessons that we have identified through the lens of preclinical systematic review and meta-analysis.","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44930590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-03-01DOI: 10.1136/bmjos-2021-100259
Mira van der Naald, S. Chamuleau, J. M. L. Menon, Wim de Leeuw, J. de Haan, D. Duncker, K. Wever
{"title":"Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu","authors":"Mira van der Naald, S. Chamuleau, J. M. L. Menon, Wim de Leeuw, J. de Haan, D. Duncker, K. Wever","doi":"10.1136/bmjos-2021-100259","DOIUrl":"https://doi.org/10.1136/bmjos-2021-100259","url":null,"abstract":"Open, prospective registration of a study protocol can improve research rigour in a number of ways. Through preregistration, key features of the study’s methodology are recorded and maintained as a permanent record, enabling comparison of the completed study with what was planned. By recording the study hypothesis and planned outcomes a priori, preregistration creates transparency and can reduce the risk of several common biases, such as hypothesising after results are known and outcome switching or selective outcome reporting. Second, preregistration raises awareness of measures to reduce bias, such as randomisation and blinding. Third, preregistration provides a comprehensive listing of planned studies, which can prevent unnecessary duplication and reduce publication bias. Although commonly acknowledged and applied in clinical research since 2000, preregistration of animal studies is not yet the norm. In 2018 we launched the first dedicated, open, online register for animal study protocols: wwwpreclinicaltrialseu. Here, we provide insight in the development of preclinicaltrials.eu (PCT) and evaluate its use during the first 3 years after its launch. Furthermore, we elaborate on ongoing developments such as the rise of comparable registries, increasing support for preregistration in the Netherlands—which led to the funding of PCT by the Dutch government—and pilots of mandatory preregistration by several funding bodies. We show the international coverage of currently registered protocols but with the overall low number of (pre)registered protocols.","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"63868869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ Open SciencePub Date : 2022-01-18eCollection Date: 2022-01-01DOI: 10.1136/bmjos-2021-100235
Naomi Shinotsuka, Franziska Denk
{"title":"Fibroblasts: the neglected cell type in peripheral sensitisation and chronic pain? A review based on a systematic search of the literature.","authors":"Naomi Shinotsuka, Franziska Denk","doi":"10.1136/bmjos-2021-100235","DOIUrl":"10.1136/bmjos-2021-100235","url":null,"abstract":"<p><p>Chronic pain and its underlying biological mechanisms have been studied for many decades, with a myriad of molecules, receptors and cell types known to contribute to abnormal pain sensations. Besides an obvious role for neurons, immune cells like microglia, macrophages and T cells are also important drivers of persistent pain. While neuroinflammation has therefore been widely studied in pain research, there is one cell type that appears to be rather neglected in this context: the humble fibroblast. Fibroblasts may seem unassuming but actually play a major part in regulating immune cell function and driving chronic inflammation. Here, our aim was to determine the breadth and quality of research that implicates fibroblasts in chronic pain conditions and models.</p><p><strong>Objectives: </strong>We set out to analyse the current literature on this topic-using systematic screening and data extraction methods to obtain a balanced view on what has been published.</p><p><strong>Methods: </strong>We categorised the articles we included-stratifying them according to what was investigated, the estimated quality of results and any common conclusions.</p><p><strong>Results: </strong>We found that there has been surprisingly little research in this area: 134 articles met our inclusion criteria, only a tiny minority of which directly investigated interactions between fibroblasts and peripheral neurons.</p><p><strong>Conclusions: </strong>Fibroblasts are a ubiquitous cell type and a prominent source of many proalgesic mediators in a wide variety of tissues. We think that they deserve a more central role in pain research and propose a new, testable model of how fibroblasts might drive peripheral neuron sensitisation.</p>","PeriodicalId":9212,"journal":{"name":"BMJ Open Science","volume":" ","pages":"e100235"},"PeriodicalIF":0.0,"publicationDate":"2022-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8768938/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39772106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}