Data use under the NIH GWAS data sharing policy and future directions.
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ABSTRACT:
SUBMITTER: Paltoo DN
PROVIDER: S-EPMC4182942 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:As librarians are generally advocates of open access and data sharing, it is a bit surprising that peer-reviewed journals in the field of librarianship have been slow to adopt data sharing policies. Starting October 1, 2019, the is taking a step forward and implementing a firm data sharing policy to increase the rigor and reproducibility of published research, enable data reuse, and promote open science. This editorial explains the data sharing policy, describes how compliance with the policy will fit into the journal’s workflow, and provides further guidance for preparing for data sharing.
| S-EPMC6774558 | biostudies-other
Project description:BackgroundRecent advances in understanding molecular and synaptic mechanisms of intellectual disabilities (ID) in fragile X syndrome (FXS) and Down syndrome (DS) through animal models have led to targeted controlled trials with pharmacological agents designed to normalize these underlying mechanisms and improve clinical outcomes. However, several human clinical trials have failed to demonstrate efficacy of these targeted treatments to improve surrogate behavioral endpoints. Because the ultimate index of disease modification in these disorders is amelioration of ID, the validation of cognitive measures for tracking treatment response is essential. Here, we present preliminary research to validate the National Institutes of Health Toolbox Cognitive Battery (NIH-TCB) for ID.MethodsWe completed three pilot studies of patients with FXS (total n = 63; mean age 19.3 ± 8.3 years, mean mental age 5.3 ± 1.6 years), DS (n = 47; mean age 16.1 ± 6.2, mean mental age 5.4 ± 2.0), and idiopathic ID (IID; n = 16; mean age 16.1 ± 5.0, mean mental age 6.6 ± 2.3) measuring processing speed, executive function, episodic memory, word/letter reading, receptive vocabulary, and working memory using the web-based NIH-TB-CB, addressing feasibility, test-retest reliability, construct validity, ecological validity, and syndrome differences and profiles.ResultsFeasibility was good to excellent (≥80 % of participants with valid scores) for above mental age 4 years for all tests except list sorting (working memory). Test-retest stability was good to excellent, and convergent validity was similar to or better than results obtained from typically developing children in the normal sample for executive function and language measures. Examination of ecological validity revealed moderate to very strong correlations between the NIH-TCB composite and adaptive behavior and full-scale IQ measures. Syndrome/group comparisons demonstrated significant deficits for the FXS and DS groups relative to IID on attention and inhibitory control, a significant reading weakness for FXS, and a receptive vocabulary weakness for DS.ConclusionsThe NIH-TCB has potential for assessing important dimensions of cognition in persons with ID, and several tests may be useful for tracking response to intervention. However, more extensive psychometric studies, evaluation of the NIH-TCB's sensitivity to change, both developmentally and in the context of treatment, and perhaps establishing links to brain function in these populations, are required to determine the true utility of the battery as a set of outcome measures.
| S-EPMC5012003 | biostudies-literature
Project description:PurposeTo identify co-produced multi-stakeholder perspectives important for successful widespread physically active learning (PAL) adoption and implementation.MethodsA total of 35 stakeholders (policymakers n?=?9; commercial education sector, n?=?8; teachers, n?=?3; researchers, n?=?15) attended a design thinking PAL workshop. Participants formed 5 multi-disciplinary groups with at least 1 representative from each stakeholder group. Each group, facilitated by a researcher, undertook 2 tasks: (1) using Post-it Notes, the following question was answered: within the school day, what are the opportunities for learning combined with movement? and (2) structured as a washing-line task, the following question was answered: how can we establish PAL as the norm? All discussions were audio-recorded and transcribed. Inductive analyses were conducted by 4 authors. After the analyses were complete, the main themes and subthemes were assigned to 4 predetermined categories: (1) PAL design and implementation, (2) priorities for practice, (3) priorities for policy, and (4) priorities for research.ResultsThe following were the main themes for PAL implementation: opportunities for PAL within the school day, delivery environments, learning approaches, and the intensity of PAL. The main themes for the priorities for practice included teacher confidence and competence, resources to support delivery, and community of practice. The main themes for the policy for priorities included self-governance, the Office for Standards in Education, Children's Services, and Skill, policy investment in initial teacher training, and curriculum reform. The main themes for the research priorities included establishing a strong evidence base, school-based PAL implementation, and a whole-systems approach.ConclusionThe present study is the first to identify PAL implementation factors using a combined multi-stakeholder perspective. To achieve wider PAL adoption and implementation, future interventions should be evidence based and address implementation factors at the classroom level (e.g., approaches and delivery environments), school level (e.g., communities of practice), and policy level (e.g., initial teacher training).
| S-EPMC6943765 | biostudies-literature
Project description:BackgroundAs genomic science moves beyond government-academic collaborations into routine healthcare operations, nursing's holistic philosophy and evidence-based practice approach positions nurses as leaders to advance genomics and precision health care in routine patient care.PurposeTo examine the status of and identify gaps for U.S. genomic nursing health care policy and precision health clinical practice implementation.MethodsWe conducted a scoping review and policy priorities analysis to clarify key genomic policy concepts and definitions, and to examine trends and utilization of health care quality benchmarking used in precision health.FindingsGenomic nursing health care policy is an emerging area. Educating and training the nursing workforce to achieve full dissemination and integration of precision health into clinical practice remains an ongoing challenge. Use of health care quality measurement principles and federal benchmarking performance evaluation criteria for precision health implementation are not developed.DiscussionNine recommendations were formed with calls to action across nursing practice workforce and education, nursing research, and health care policy arenas.ConclusionsTo advance genomic nursing health care policy, it is imperative to develop genomic performance measurement tools for clinicians, purchasers, regulators and policymakers and to adequately prepare the nursing workforce.
| S-EPMC8282091 | biostudies-literature
Project description:As researchers, we are advised to share our data to improve transparency and increase the reproducibility of experiments. Simultaneously, making data freely accessible can raise ethical questions regarding the participants' privacy. We first outline the challenges regarding "open data" for researchers in light of the GDPR. Then, we turn to the impact of an open-access data sharing policy on the participants: could the participants' knowledge about the future use of the data alter the data itself? Through two pre-registered studies (N = 193, collected on campus and N = 543, online participation), we investigate whether disclosing that anonymized data will be publicly shared vs. not shared influences a potential participants' intention to take part in the study. Using both frequentist and Bayesian analysis, we conclude towards an absence of effect of a difference in data sharing policy on scores in the Big Five questionnaire and social desirability, careless response behavior, and results in the anchoring paradigm. In the second study, a lexicometric analysis of participants' reactions to openly sharing data reveals a readiness to share data and support transparency under the condition of preserved anonymity. Hence, if anonymity can be ensured, there seems to be no methodological or ethical drawback in transparent and open data sharing policies for many psychological studies.
| S-EPMC6753307 | biostudies-literature
Project description:Transparency, openness, and reproducibility are important characteristics in scientific publishing. Although many researchers embrace these characteristics, data sharing has yet to become common practice. Nevertheless, data sharing is becoming an increasingly important topic among societies, publishers, researchers, patient advocates, and funders, especially as it pertains to data from clinical trials. In response, ASTRO developed a data policy and guide to best practices for authors submitting to its journals. ASTRO's data sharing policy is that authors should indicate, in data availability statements, if the data are being shared and if so, how the data may be accessed.
| S-EPMC6817515 | biostudies-literature
Project description:Acquired T790 M mutation is the commonest cause of resistance for advanced non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR) mutant patients who had progressed after first line EGFR TKI (tyrosine kinase inhibitor). Several third generation EGFR TKIs which are EGFR mutant selective and wild-type (WT) sparing were developed to treat these patients with T790 M acquired resistant mutation. Osimertinib is one of the third generation EGFR TKIs and is currently the most advanced in clinical development. Unfortunately, despite good initial response, patients who was treated with third generation EGFR TKI would develop acquired resistance and several mechanisms had been identified and the commonest being C797S mutation at exon 20. Several novel treatment options were being developed for patients who had progressed on third generation EGFR TKI but they are still in the early phase of development. Osimertinib under FLAURA study had been shown to have better progression-free survival over first generation EGFR TKI in the first line setting and likely will become the new standard of care.
| S-EPMC5817792 | biostudies-literature
Project description:Alcohol and substance use, until recently, were believed to be a predominantly male phenomenon. Only in the last few decades, attention has shifted to female drug use and its repercussions in women. As the numbers of female drug users continue to rise, studies attempt to understand gender-specific etiological factors, phenomenology, course and outcome, and issues related to treatment with the aim to develop more effective treatment programs. Research has primarily focused on alcohol and tobacco in women, and most of the literature is from the Western countries with data from developing countries like India being sparse. This review highlights the issues pertinent to alcohol and substance use in women with a special focus to the situation in India.
| S-EPMC4539872 | biostudies-other
Project description:To characterise experiences using clinical research data shared through the National Institutes of Health (NIH)'s Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) clinical research data repository, along with data recipients' perceptions of the value, importance and challenges with using BioLINCC data.Cross-sectional web-based survey.All investigators who requested and received access to clinical research data from BioLINCC between 2007 and 2014.Reasons for BioLINCC data request, research project plans, interactions with original study investigators, BioLINCC experience and other project details.There were 536 investigators who requested and received access to clinical research data from BioLINCC between 2007 and 2014. Of 441 potential respondents, 195 completed the survey (response rate=44%); 89% (n=174) requested data for an independent study, 17% (n=33) for pilot/preliminary analysis. Commonly cited reasons for requesting data through BioLINCC were feasibility of collecting data of similar size and scope (n=122) and insufficient financial resources for primary data collection (n=76). For 95% of respondents (n=186), a primary research objective was to complete new research, as opposed to replicate prior analyses. Prior to requesting data from BioLINCC, 18% (n=36) of respondents had contacted the original study investigators to obtain data, whereas 24% (n=47) had done so to request collaboration. Nearly all (n=176; 90%) respondents found the data to be suitable for their proposed project; among those who found the data unsuitable (n=19; 10%), cited reasons were data too complicated to use (n=5) and data poorly organised (n=5). Half (n=98) of respondents had completed their proposed projects, of which 67% (n=66) have been published.Investigators were primarily using clinical research data from BioLINCC for independent research, making use of data that would otherwise have not been feasible to collect.
| S-EPMC5051517 | biostudies-literature
Project description:IntroductionThe opioid crisis is a pervasive public health threat in the U.S. Simulation modeling approaches that integrate a systems perspective are used to understand the complexity of this crisis and analyze what policy interventions can best address it. However, limitations in currently available data sources can hamper the quantification of these models.MethodsTo understand and discuss data needs and challenges for opioid systems modeling, a meeting of federal partners, modeling teams, and data experts was held at the U.S. Food and Drug Administration in April 2019. This paper synthesizes the meeting discussions and interprets them in the context of ongoing simulation modeling work.ResultsThe current landscape of national-level quantitative data sources of potential use in opioid systems modeling is identified, and significant issues within data sources are discussed. Major recommendations on how to improve data sources are to: maintain close collaboration among modeling teams, enhance data collection to better fit modeling needs, focus on bridging the most crucial information gaps, engage in direct and regular interaction between modelers and data experts, and gain a clearer definition of policymakers' research questions and policy goals.ConclusionsThis article provides an important step in identifying and discussing data challenges in opioid research generally and opioid systems modeling specifically. It also identifies opportunities for systems modelers and government agencies to improve opioid systems models.
| S-EPMC8061725 | biostudies-literature