1,091 research outputs found

    Protocol for a retrospective, controlled cohort study of the impact of a change in Nature journals' editorial policy for life sciences research on the completeness of reporting study design and execution

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    In recent years there has been increasing concern about the rigor of laboratory research. Here we present the protocol for a study comparing the completeness of reporting of in vivo and in vitro research carried in Nature Publication Group journals before and after the introduction of a change in editorial policy (the introduction of a set of guidelines for reporting); and in similar research published in other journals in the same periods. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11192-016-1964-8) contains supplementary material, which is available to authorized users

    The Write Stuff - Winter 2019 (Vol.16, No.1)

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    Grant Writers\u27 seminars return in March How to disagree with an NIH research grant proposal review Using Publons to track and show peer reviews Journal initiatives aim to improve transparency and reproducibility New NIH videos demystify the grant review process NIH launches new version of NIH Data Book including 2018 funding statistics Unusual terms used in scientific writing and publishing: Sentence case and title casehttps://openworks.mdanderson.org/writestuff_2019/1002/thumbnail.jp

    Patient registries in rare diseases: identifying the specific issues and potential solutions to improve quality data and outcomes = Registros de pacientes en enfermedades raras: identificación de problemas específicos y soluciones potenciales para mejorar la calidad de los datos y resultados

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    285 p.Esta tesis ha sido realizada con el objetivo de identificar las necesidades no cubiertas en las guías sobre registros de pacientes y ofrecer posibles soluciones a estas cuestiones, para ayudar a mejorar la calidad y la sostenibilidad en futuros registros de enfermedades raras. La experiencia adquirida en primera persona al liderar uno de los mayores registros de enfermedades raras, desde su concepción hasta la publicación de los resultados, ha permitido una comprensión profunda de este tipo de registros de pacientes, sus problemas específicos y las medidas pertinentes que deben tomarse para evitarlos. = This thesis was conducted with the objective to identify the unmet needs in the guidance on rare disease patient registries and offer potential solutions to these issues, to help to improve the quality and sustainability in the future registries in rare diseases. Gathering a first hand experience while leading one of the largest rare disease registry, from inception to publication, has offered intensive understanding of rare diseases registries, its specific concerns and related measures to be taken to avoid these issues

    Toward Good In Vitro Reporting Standards

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    A good experiment reported badly is worthless. Meaningful contributions to the body of science are made by sharing the full methodology and results so that they can be evaluated and reproduced by peers. Erroneous and incomplete reporting does not do justice to the resources spent on conducting the experiment and the time peers spend reading the article. In theory peer-review should ensure adequate reporting – in practice it does not. Many areas have developed reporting standards and checklists to support the adequate reporting of scientific efforts, but in vitro research still has no generally accepted criteria. It is characterized by a “Wild West” or “anything goes” attitude. Such a culture may undermine trust in the reproducibility of animal-free methods, and thus parallel the “reproducibility crisis” discussed for other life science fields. The increasing data retrieval needs of computational approaches (in extreme as “big data” and artificial intelligence) makes reporting quality even more important so that the scientific community can take full advantage of the results. The first priority of reporting standards is to ensure the completeness and transparency of information provided (data focus). The second tier is a quality of data display that makes information digestible and easy to grasp, compare and further analyze (information focus). This article summarizes a series of initiatives geared towards improving the quality of in vitro work and its reporting. This shall ultimately lead to Good In Vitro Reporting Standards (GIVReSt)

    Intervention Now to Eliminate Repeat Unintended Pregnancy in Teenagers (INTERUPT): a systematic review of intervention effectiveness and cost-effectiveness, and qualitative and realist synthesis of implementation factors and user engagement

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    Background The UK has one of the highest rates of teenage pregnancies in Western Europe. One-fifth of these are repeat pregnancies. Unintended conceptions can cause substantial emotional, psychological and educational harm to teenagers, often with enduring implications for life chances. Babies of teenage mothers have increased mortality and are at a significantly increased risk of poverty, educational underachievement and unemployment later in life, with associated costs to society. It is important to identify effective, cost-effective and acceptable interventions. Objectives To identify who is at the greatest risk of repeat unintended pregnancies; which interventions are effective and cost-effective; and what the barriers to and facilitators of the uptake of these interventions are. Data sources We conducted a multistreamed, mixed-methods systematic review informed by service user and provider consultation to examine worldwide peer-reviewed evidence and UK-generated grey literature to find and evaluate interventions to reduce repeat unintended teenage pregnancies. We searched the following electronic databases: MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and the Health Technology Assessment Database), EMBASE (Excerpta Medica database), British Nursing Index, Educational Resources Information Center, Sociological Abstracts, Applied Social Sciences Index and Abstracts, BiblioMap (the Evidence for Policy and Practice Information and Co-ordinating Centre register of health promotion and public health research), Social Sciences Citation Index (supported by Web of Knowledge), Research Papers in Economics, EconLit (American Economic Association’s electronic bibliography), OpenGrey, Scopus, Scirus, Social Care Online, National Research Register, National Institute for Health Research Clinical Research Network Portfolio and Index to THESES. Searches were conducted in May 2013 and updated in June 2014. In addition, we conducted a systematic search of Google (Google Inc., Mountain View, CA, USA) in January 2014. Database searches were guided by an advisory group of stakeholders. Review methods To address the topic’s complexities, we used a structured, innovative and iterative approach combining methods tailored to each evidence stream. Quantitative data (effectiveness, cost-effectiveness, risk factors and effect modifiers) were synthesised with reference to Cochrane guidelines for evaluating evidence on public health interventions. Qualitative evidence addressing facilitators of and barriers to the uptake of interventions, experience and acceptability of interventions was synthesised thematically. We applied the principles of realist synthesis to uncover theories and mechanisms underpinning interventions (what works, for whom and in what context). Finally, we conducted an overarching narrative of synthesis of evidence and gathered service user feedback. Results We identified 8664 documents initially, and 816 in repeat searches. We filtered these to 12 randomised controlled trials (RCTs), four quasi-RCTs, 10 qualitative studies and 53 other quantitative studies published between 1996 and 2012. None of the RCTs was based in the UK. The RCTs evaluated an emergency contraception programme and psychosocial interventions. We found no evidence for effectiveness with regard to condom use, contraceptive use or rates of unprotected sex or use of birth control. Our primary outcome was repeat conception rate: the event rate was 132 of 308 (43%) in the intervention group versus 140 of 289 (48%) for the control goup, with a non-significant risk ratio (RR) of 0.92 [95% confidence interval (CI) 0.78 to 1.08]. Four studies reported subsequent birth rates: 29 of 237 (12%) events for the intervention arm versus 46 out of 224 (21%) for the control arm, with a RR of 0.60 (95% CI 0.39 to 0.93). Many repeat conceptions occurred in the context of poverty, low expectations and aspirations, and negligible opportunities. Service user feedback suggested that there were specific motivations for many repeat conceptions, for example to replace loss or to please a partner. Realist synthesis highlighted that context, motivation, planning for the future and letting young women take control with connectedness and tailoring provide a conceptual framework for future research. Limitations Included studies rarely characterised adolescent pregnancy as intended or unintended, that is interventions to reduce repeat conceptions rarely addressed whether or not pregnancies were intended. Furthermore, interventions were often not clearly defined, had multiple aims and did not indicate which elements were intended to address which aims. Nearly all of the studies were conducted in the USA and focused largely on African American or Hispanic and Latina American populations. Conclusions We found no evidence to indicate that existing interventions to reduce repeat teenage pregnancy were effective; however, subsequent births were reduced by home-based interventions. Qualitative and realist evidence helped to explain gaps in intervention design that should be addressed. More theory-based, rigorously evaluated programmes need to be developed to reduce repeat teenage pregnancy in the UK. Study registration This study is registered as PROSPERO CRD42012003168. Cochrane registration number: i=fertility/0068. Funding The National Institute for Health Research Health Technology Assessment programme

    Good Research Practice in Non-Clinical Pharmacology and Biomedicine

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    This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine

    The Use of Routinely Collected Data in Clinical Trial Research

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    RCTs are the gold standard for assessing the effects of medical interventions, but they also pose many challenges, including the often-high costs in conducting them and a potential lack of generalizability of their findings. The recent increase in the availability of so called routinely collected data (RCD) sources has led to great interest in their application to support RCTs in an effort to increase the efficiency of conducting clinical trials. We define all RCTs augmented by RCD in any form as RCD-RCTs. A major subset of RCD-RCTs are performed at the point of care using electronic health records (EHRs) and are referred to as point-of-care research (POC-R). RCD-RCTs offer several advantages over traditional trials regarding patient recruitment and data collection, and beyond. Using highly standardized EHR and registry data allows to assess patient characteristics for trial eligibility and to examine treatment effects through routinely collected endpoints or by linkage to other data sources like mortality registries. Thus, RCD can be used to augment traditional RCTs by providing a sampling framework for patient recruitment and by directly measuring patient relevant outcomes. The result of these efforts is the generation of real-world evidence (RWE). Nevertheless, the utilization of RCD in clinical research brings novel methodological challenges, and issues related to data quality are frequently discussed, which need to be considered for RCD-RCTs. Some of the limitations surrounding RCD use in RCTs relate to data quality, data availability, ethical and informed consent challenges, and lack of endpoint adjudication which may all lead to uncertainties in the validity of their results. The purpose of this thesis is to help fill the aforementioned research gaps in RCD-RCTs, encompassing tasks such as assessing their current application in clinical research and evaluating the methodological and technical challenges in performing them. Furthermore, it aims to assess the reporting quality of published reports on RCD-RCTs

    Transepithelial accelerated corneal collagen crosslinking in patients with progressive keratoconus: long term follow up results

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    Objetivo: avaliar de forma sistematizada a eficácia a longo prazo do crosslinking de colagénio corneano transepitelial acelerado (TE-ACXL) no tratamento de olhos com queratocone progressivo, reportando os seus outcomes visuais e morfológicos ao longo de um follow-up de 4 anos. Métodos: olhos de pacientes submetidos a TE-ACXL (6mW/cm2 durante 15 minutos) para queratocone progressivo foram incluídos neste estudo de coorte retrospetivo. Melhor acuidade visual corrigida (BCVA), valores queratométricos, paquimetria corneana mínima (PachyMin) e índices topográficos foram analisados pré-operatoriamente e a cada 6 meses após o TE-ACXL, até um máximo de 48 meses. A progressão da doença foi definida como um aumento ≥ 1.00 D do astigmatismo corneano, um aumento ≥ 1.00 D da queratometria máxima (Kmax), uma redução ≥ 2% da PachyMin ou um aumento ≥ 0.42 unidades do D-index. Resultados: o estudo envolveu 39 olhos de 30 pacientes. Não foram observadas diferenças estatisticamente significativas na BCVA, astigmatismo corneano, Kmax, índice de variação da superfície corneana (ISV), índice de descentralização por elevação da córnea (IHD) e índice queratocone (KI) entre a avaliação de base e as avaliações subsequentes (p>0.05). Houve um aumento significativo aos 12, 24 e 36 meses de seguimento na queratometria média (Km) (0.66 ± 1.07 D, p=0.001; 0.94 ± 1,42 D, p=0.001; 1.48 ± 1.19 D, p=0.002) e D-index (0.50 ± 1.05 unidades, p=0.011; 0.53 ± 1.19 unidades, p=0.024; 1.29 ± 1.11 unidades, p=0.003). Houve uma redução estatisticamente significativa na PachyMin aos 36 meses (-10.45 ± 15.20 µm, p=0.046) e no índice de assimetria vertical da córnea (IVA) aos 24 meses (-0.07 ± 0.16 unidades, p=0.024). 28 (71.8%) olhos mantiveram progressão por pelo menos um critério. 2 (5.1%) olhos cumpriram os 4 critérios de progressão definidos. Não foram registadas complicações durante a cirurgia ou seguimento em nenhum dos doentes. Conclusão: o TE-ACXL parece ser um tratamento seguro e eficaz no tratamento do queratocone progressivo. Recomenda-se a definição de novos critérios de progressão específicos e significativos e estudos prospetivos adicionais com coortes mais alargados.Purpose: to systematically evaluate the long-term efficacy of transepithelial accelerated corneal collagen crosslinking (TE-ACXL) in the treatment of eyes with progressive keratoconus by reporting its visual and morphological outcomes throughout a 4-year follow-up. Methods: eyes of patients who underwent TE-ACXL (6mW/cm2 for 15 minutes) for progressive keratoconus were included in this retrospective cohort study. Best-corrected visual acuity (BCVA), keratometry measurements, thinnest corneal thickness (PachyMin), and topographic indexes were analyzed preoperatively and every 6 months after TE-ACXL, up to a maximum of 48 months. Disease progression was defined as an increase ≥ 1.00 D in corneal astigmatism, an increase ≥ 1.00 D in maximum keratometry (Kmax), a decrease ≥ 2% in PachyMin, or an increase ≥ 0.42 units in D-index. Results: the study enrolled 39 eyes from 30 patients. No significant differences were observed in BCVA, corneal astigmatism, Kmax, index of surface variance (ISV), index of height decentration (IHD), and keratoconus index (KI) between baseline and subsequent follow-up evaluations (p>0.05). There was a significant increase at 12-, 24- and 36-months follow-up in mean keratometry (Km) (0.66 ± 1.07 D, p=0.001; 0.94 ± 1,42 D, p=0.001; 1.48 ± 1.19 D, p=0.002) and D-index (0.50 ± 1.05 units, p=0.011; 0.53 ± 1.19 units, p=0.024; 1.29 ± 1.11 units, p=0.003). There were significant decreases in PachyMin at 36 months (-10.45 ± 15.20 µm, p=0.046) and in index of vertical asymmetry (IVA) at 24 months (-0.07 ± 0.16 units, p=0.024). 28 (71.8%) eyes maintained progression by at least one criterion. 2 (5.1%) eyes fulfilled all 4 progression criteria. Surgery and follow-up were uneventful in all subjects. Conclusion: TE-ACXL seems to be a safe and effective treatment for progressive keratoconus. Definition of new specific and significant progression criteria and further prospective studies with larger cohorts are recommended
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