Data Archiving and Networked Services (DANS)

There is an urgent need to improve the infrastructure supporting the reuse of scholarly data. A diverse set of stakeholders-representing academia, industry, funding agencies, and scholarly publishers-have come together to design and jointly endorse a concise and measureable set of principles that we refer to as the FAIR Data Principles. The intent is that these may act as a guideline for those wishing to enhance the reusability of their data holdings. Distinct from peer initiatives that focus on the human scholar, the FAIR Principles put specific emphasis on enhancing the ability of machines to automatically find and use the data, in addition to supporting its reuse by individuals. This Comment is the first formal publication of the FAIR Principles, and includes the rationale behind them, and some exemplar implementations in the community.

OBJECTIVE: Several treatment strategies have proven value in the amelioration of rheumatoid arthritis (RA), but the optimal strategy for preventing long-term joint damage and functional decline is unclear. We undertook this study to compare clinical and radiographic outcomes of 4 different treatment strategies, with intense monitoring in all patients. METHODS: In a multicenter, randomized clinical trial, 508 patients were allocated to 1 of 4 treatment strategies: sequential disease-modifying antirheumatic drug monotherapy (group 1), step-up combination therapy (group 2), initial combination therapy with tapered high-dose prednisone (group 3), and initial combination therapy with the tumor necrosis factor antagonist infliximab (group 4). Treatment adjustments were made every 3 months in an effort to obtain low disease activity (a Disease Activity Score in 44 joints of < or =2.4). RESULTS: Initial combination therapy including either prednisone (group 3) or infliximab (group 4) resulted in earlier functional improvement than did sequential monotherapy (group 1) and step-up combination therapy (group 2), with mean scores at 3 months on the Dutch version of the Health Assessment Questionnaire (D-HAQ) of 1.0 in groups 1 and 2 and 0.6 in groups 3 and 4 (P < 0.001). After 1 year, mean D-HAQ scores were 0.7 in groups 1 and 2 and 0.5 in groups 3 and 4 (P = 0.009). The median increases in total Sharp/Van der Heijde radiographic joint score were 2.0, 2.5, 1.0, and 0.5 in groups 1-4, respectively (P < 0.001). There were no significant differences in the number of adverse events and withdrawals between the groups. CONCLUSION: In patients with early RA, initial combination therapy including either prednisone or infliximab resulted in earlier functional improvement and less radiographic damage after 1 year than did sequential monotherapy or step-up combination therapy.

We work from a life course perspective and identify several reasons to expect age and gender differences in the link between marital quality and health. We present growth curve evidence from a national longitudinal survey to show that marital strain accelerates the typical decline in self-rated health that occurs over time and that this adverse effect is greater at older ages. These findings fit with recent theoretical work on cumulative adversity in that marital strain seems to have a cumulative effect on health over time-an effect that produces increasing vulnerability to marital strain with age. Contrary to expectations, marital quality seems to affect the health of men and women in similar ways across the life course.

The FAIR principles have been widely cited, endorsed and adopted by a broad range of stakeholders since their publication in 2016. By intention, the 15 FAIR guiding principles do not dictate specific technological implementations, but provide guidance for improving Findability, Accessibility, Interoperability and Reusability of digital resources. This has likely contributed to the broad adoption of the FAIR principles, because individual stakeholder communities can implement their own FAIR solutions. However, it has also resulted in inconsistent interpretations that carry the risk of leading to incompatible implementations. Thus, while the FAIR principles are formulated on a high level and may be interpreted and implemented in different ways, for true interoperability we need to support convergence in implementation choices that are widely accessible and (re)-usable. We introduce the concept of FAIR implementation considerations to assist accelerated global participation and convergence towards accessible, robust, widespread and consistent FAIR implementations. Any self-identified stakeholder community may either choose to reuse solutions from existing implementations, or when they spot a gap, accept the challenge to create the needed solution, which, ideally, can be used again by other communities in the future. Here, we provide interpretations and implementation considerations (choices and challenges) for each FAIR principle.

As information and communication technology has become pervasive in our society, we are increasingly dependent on both digital data and repositories that provide access to and enable the use of such resources. Repositories must earn the trust of the communities they intend to serve and demonstrate that they are reliable and capable of appropriately managing the data they hold.

Abstract This paper gives an introduction to multivariate calibration from a chemometrics perspective and reviews the various proposals to generalize the well-established univariate methodology to the multivariate domain. Univariate calibration leads to relatively simple models with a sound statistical underpinning. The associated uncertainty estimation and figures of merit are thoroughly covered in several official documents. However, univariate model predictions for unknown samples are only reliable if the signal is sufficiently selective for the analyte of interest. By contrast, multivariate calibration methods may produce valid predictions also from highly unselective data. A case in point is quantification from near-infrared (NIR) spectra. With the ever-increasing sophistication of analytical instruments inevitably comes a suite of multivariate calibration methods, each with its own underlying assumptions and statistical properties. As a result, uncertainty estimation and figures of merit for multivariate calibration methods has become a subject of active research, especially in the field of chemometrics.

Integrating Artificial Intelligence (AI) and robotics in healthcare heralds a new era of medical innovation, promising enhanced diagnostics, streamlined processes, and improved patient care. However, this technological revolution is accompanied by intricate ethical implications that demand meticulous consideration. This article navigates the complex ethical terrain surrounding AI and robotics in healthcare, delving into specific dimensions and providing strategies and best practices for ethical navigation. Privacy and data security are paramount concerns, necessitating robust encryption and anonymization techniques to safeguard patient data. Responsible data handling practices, including decentralized data sharing, are critical to preserve patient privacy. Algorithmic bias poses a significant challenge, demanding diverse datasets and ongoing monitoring to ensure fairness. Transparency and explainability in AI decision-making processes enhance trust and accountability. Clear responsibility frameworks are essential to address the accountability of manufacturers, healthcare institutions, and professionals. Ethical guidelines, regularly updated and accessible to all stakeholders, guide decision-making in this dynamic landscape. Moreover, the societal implications of AI and robotics extend to accessibility, equity, and societal trust. Strategies to bridge the digital divide and ensure equitable access must be prioritized. Global collaboration is pivotal in developing adaptable regulations and addressing legal challenges like liability and intellectual property. Ethics must remain at the forefront in the ever-evolving realm of healthcare technology. By embracing these strategies and best practices, healthcare systems and professionals can harness the potential of AI and robotics, ensuring responsible and ethical integration that benefits patients while upholding the highest ethical standards.

The CODATA&nbsp;Data Science Journal&nbsp;is a peer-reviewed, open access, electronic journal, publishing papers on the management, dissemination, use and reuse of research data and databases across all research domains, including science, technology, the humanities and the arts. The scope of the journal includes descriptions of data systems, their implementations and their publication, applications, infrastructures, software, legal, reproducibility and transparency issues, the availability and usability of complex datasets, and with a particular focus on the principles, policies and practices for open data.All data is in scope, whether born digital or converted from other sources.

In fibrosing hearts, myofibroblasts are associated with cardiac extracellular matrix remodeling. Expression of key genes in the transition of cardiac fibroblast to myofibroblast phenotype in post-myocardial infarction heart and in vitro has not been well addressed. Contractile, focal adhesion-associated, receptor proteins, fibroblast growth factor-2 (FGF-2) expression, and motility were compared to assess phenotype in adult and neonatal rat cardiac fibroblasts and myofibroblasts. Neonatal and adult fibroblasts undergo phenotypic transition to myofibroblastic cells, marked by increased alpha-smooth muscle actin (alphaSMA), smooth muscle myosin heavy chain (SMemb), extra domain-A (ED-A) fibronectin, paxillin, tensin, FGF-2, and TbetaRII receptor. Elevated ED-A fibronectin confirmed fibroblast to supermature myofibroblastic phenotype transition. Presence of myofibroblasts in vivo was noted in sections of healed infarct scar after myocardial infarction, and their expression is similar to that in culture. Thus, cultured neonatal and adult cardiac fibroblasts transition to myofibroblasts in vitro and share expression profiles of cardiac myofibroblasts in vivo. Reduced motility with in vitro passage reflects enhanced production of focal adhesions.

Addendum to: Scientific Data https://doi.org/10.1038/sdata.2016.18, published online 15 March 2016&#13;\n&#13;\nSince publication, the URL at which the FAIR principles ‘living document’ is hosted and maintained has changed from http://datafairport.org/fair-principles-living-document-menu to https://www.go-fair.org/fair-principles/.

Recently, the need to contribute to the evaluation of the scientific, social and political impact of social sciences and humanities (SSH) research has become a demand of policy makers and society. The international scientific community has made significant advances that have transformed the impact evaluation landscape. This paper reviews the existing scientific knowledge on evaluation tools and techniques that are applied to assess the scientific impact of SSH research; the changing structure of social and political impacts of SSH research is investigated based on an overarching research question: to what extent do scholars attempt to apply methods, instruments and approaches that take into account the distinctive features of SSH? The review also includes examples of EU projects that demonstrate these impacts. This paper culminates in a discussion of the development of the assessment of different impacts and identifies limitations, and areas and topics to explore in the future.

OBJECTIVE: To assess the proportion of patients starting with antihypertensive drug treatment who continued treatment for at least 10 years. DESIGN: A retrospective cohort study. SETTING: The PHARMO record linkage system containing drug dispensing records from community pharmacies and linked hospital discharge records of approximately 950 000 subjects. PARTICIPANTS: Patients who started using antihypertensive drugs (two or more prescriptions) in 1992 and did not receive a prescription for any antihypertensive drug in the 365 days preceding the first prescription. MAIN OUTCOME MEASURE: Persistence with antihypertensive drugs until 10 years. RESULTS: Among a total of 2325 patients who started using antihypertensive drugs, 39% used continuously during the 10 years of follow-up. Approximately 22% temporarily discontinued and restarted treatment, whereas 39% of patients discontinued permanently. Older patients were more persistent than younger patients [20-39 years: odds ratio (OR) 2.08; 95% confidence interval (CI) 1.52-2.84; 40-59 years: (reference), > or = 60 years: OR 0.69; 95% CI 0.54-0.89]. More patients who started with diuretics (reference) and beta blockers (OR 1.15; 95% CI 0.87-1.52) discontinued compared with those who started with dihydropyridine calcium antagonists (OR 0.54; 95% CI 0.34-0.84), and angiotensin-converting enzyme (ACE) inhibitors (OR 0.38; 95% CI 0.27-0.55). Patients who started with combination therapy (OR 0.29; 95% CI 0.14-0.54 compared with diuretics) or patients who were initially treated by a cardiologist (OR 0.82; 95% CI 0.61-0.97) or internist (OR 0.80; 95% CI 0.62-0.98 compared with general practitioners) also showed higher persistence. CONCLUSION: Long-term persistence in daily practice is low compared with persistence observed in randomized clinical trials and should be considered in the choice of a first-line antihypertensive agent.

The FAIR Principles 1 (https:/

OBJECTIVE: To explore the clinical and financial implications of preoperative opioid use in major abdominal surgery. BACKGROUND: Opioids are increasingly used to manage chronic pain, and chronic opioid users are challenging to care for perioperatively. Given the epidemic of opioid-related morbidity and mortality, it is critical to understand how preoperative opioid use impacts surgical outcomes. METHODS: This was an analysis of nonemergent, abdominopelvic surgeries from 2008 to 2014 from a single center within the Michigan Surgical Quality Collaborative clinical registry database. Preoperative opioid use (binary exposure variable) was retrospectively queried from the home medication list of the preoperative evaluation. Our primary outcome was 90-day total hospital costs. Secondary outcomes included hospital length of stay, 30-day major complication rates, discharge destination, and 30-day hospital readmission rates. Analyses were risk-adjusted for case complexity and patient-specific risk factors such as demographics, insurance, smoking, comorbidities, and concurrent medication use. RESULTS: In all, 2413 patients met the inclusion criteria. Among them, 502 patients (21%) used opioids preoperatively. After covariate adjustment, opioid users (compared with those who were opioid-naïve) had 9.2% higher costs [95% confidence interval (CI) 2.8%-15.6%; adjusted means $26,604 vs $24,263; P = 0.005), 12.4% longer length of stay (95% CI 2.3%-23.5%; adjusted means 5.9 vs 5.2 days; P = 0.015), more complications (odds ratio 1.36; 95% CI 1.04-1.78; adjusted rates 20% vs 16%; P = 0.023), more readmissions (odds ratio 1.57; 95% CI 1.08-2.29; adjusted rates 10% vs 6%; P = 0.018), and no difference in discharge destination (P = 0.11). CONCLUSIONS: Opioid use is common before abdominopelvic surgery, and is independently associated with increased postoperative healthcare utilization and morbidity. Preoperative opioids represent a potentially modifiable risk factor and a novel target to improve quality and value of surgical care.

OBJECTIVE: To determine the feasibility and potential usefulness of mathematical models in evaluating immunomodulatory strategies in clinical trials of severe sepsis. DESIGN: Mathematical modeling of immunomodulation in simulated patients. SETTING: Computer laboratory. MEASUREMENTS AND MAIN RESULTS: We introduce and evaluate the concept of conducting a randomized clinical trial in silico based on simulated patients generated from a mechanistic mathematical model of bacterial infection, the acute inflammatory response, global tissue dysfunction, and a therapeutic intervention. Trial populations are constructed to reflect heterogeneity in bacterial load and virulence as well as propensity to mount and modulate an inflammatory response. We constructed a cohort of 1,000 trial patients submitted to therapy with one of three different doses of a neutralizing antibody directed against tumor necrosis factor (anti-TNF) for 6, 24, or 48 hrs. We present cytokine profiles over time and expected outcome for each cohort. We identify subgroups with high propensity for being helped or harmed by the proposed intervention and identify early serum markers for each of those subgroups. The mathematical simulation confirms the inability of simple markers to predict outcome of sepsis. The simulation clearly separates cases with favorable and unfavorable outcome on the basis of global tissue dysfunction. Control survival was 62.9% at 1 wk. Depending on dose and duration of treatment, survival ranged from 57.1% to 80.8%. Higher doses of anti-TNF, although effective, also result in considerable harm to patients. A statistical analysis based on a simulated cohort identified markers of favorable or adverse response to anti-TNF treatment. CONCLUSIONS: A mathematical simulation of anti-TNF therapy identified clear windows of opportunity for this intervention as well as populations that can be harmed by anti-TNF therapy. The construction of an in silico clinical trial could provide profound insight into the design of clinical trials of immunomodulatory therapies, ranging from optimal patient selection to individualized dosage and duration of proposed therapeutic interventions.

OBJECTIVE: The relationship between body mass index (BMI) and stroke incidence and mortality remains controversial, particularly in Asian populations. METHODS: We conducted a prospective cohort study in a nationally representative sample of 169,871 Chinese men and women age 40 years or older. Data on body weight was obtained at baseline examination in 1991 using a standard protocol. Follow-up evaluation was conducted in 1999 to 2000, with a response rate of 93.4%. RESULTS: After excluding those participants with missing body weight or height values, 154,736 adults were included in the analysis. During a mean follow-up of 8.3 years, 7,489 strokes occurred (3,924 fatal). After adjustment for age, gender, physical inactivity, urbanization, geographic variation, cigarette smoking, diabetes, and education, compared with participants of normal weight (BMI 18.5-24.9), relative hazard (95% confidence interval) of incident stroke was 0.86 (0.80-0.93) for participants who were underweight (BMI < 18.5), 1.43 (1.36-1.52) for those who were overweight (BMI 25-29.9), and 1.72 (1.55-1.91) for those who were obese (BMI > or = 30). The corresponding relative hazards were 0.76 (0.66-0.86), 1.60 (1.48-1.72), and 1.89 (1.66-2.16) for ischemic stroke and 1.00 (0.89-1.13), 1.18 (1.06-1.31), and 1.54 (1.27-1.87) for hemorrhagic stroke. For stroke mortality, the corresponding relative hazards were 0.94 (0.86-1.03), 1.15 (1.05-1.25), and 1.47 (1.26-1.72). Linear trends were significant for all outcomes (p < 0.0001). INTERPRETATION: These results suggest that elevated BMI increases the risk of both ischemic and hemorrhagic stroke incidence, and stroke mortality in Chinese adults.

We describe the clinicopathologic and immunohistochemical features of 16 solitary fibrous tumors (SFTs) originating within the oral soft tissues. There were 10 women and six men with a mean age at diagnosis of 56 years. In all cases the tumors were slow-growing, asymptomatic, submucosal growths of variable size and duration. The buccal mucosa was involved in 12 cases, and the tongue and lower lip were affected in two cases, respectively. Thirteen tumors developed on the left side of the mouth. Follow-up information was available in 10 cases and averaged 44.7 months, with no evidence of recurrence or metastasis. All 16 tumors were well circumscribed and demonstrated histologic features that were invariably benign. In all cases they were composed of an admixture of alternating hypercellular and hypocellular, collagenous zones; haphazardly arranged, cytologically bland spindle and ovoid cells that in areas were intimately intermixed with collagen; a prominent vasculature; and perivascular hyalinization. Immunohistochemically, the tumors were consistently positive for CD34, bcl-2, factor XIIIa, and vimentin, whereas 75% of the tumors were reactive for CD99. To further define the clinicopathologic profile of intraoral SFT, we include a review of the previously reported cases. We also include a comparison and brief review of the clinicopathologic and immunohistochemical features of other spindle cell tumors of the oral cavity, from which SFTs must be differentiated.

OBJECTIVE: To evaluate the acquisition rate, identify risk factors, and estimate the risk for subsequent infection, associated with the colonization of the digestive tract with extended-spectrum beta-lactamase-producing Enterobacteriaceae during ICU-hospitalization. DATA SOURCES: PubMed, EMBASE, and reference lists of all eligible articles. STUDY SELECTION: Included studies provided data on ICU-acquired colonization with extended-spectrum beta-lactamase-producing Enterobacteriaceae in previously noncolonized and noninfected patients and used the double disk synergy test for extended-spectrum beta-lactamase-producing Enterobacteriaceae phenotypic confirmation. Studies reporting extended-spectrum beta-lactamase-producing Enterobacteriaceae outbreaks or data on pediatric population were excluded. DATA EXTRACTION: Two authors independently assessed study eligibility and performed data extraction. DATA SYNTHESIS: Thirteen studies (with 15,045 ICUs-patients) were evaluated using a random-effect model and a meta-regression analysis. The acquisition rate of digestive tract colonization during ICU stay was 7% (95% CI, 5-10) and it varies from 3% (95% CI, 2-4) and 4% (95% CI, 2-6) in the Americas and Europe to 21% (95% CI, 9-35) in the Western Pacific region. Previous hospitalization (risk ratio, 1.57 [95% CI, 1.07-2.31]) or antibiotic use (risk ratio, 1.65 [95% CI, 1.15-2.37]) and exposure to beta-lactams/beta-lactamase inhibitors (risk ratio, 1.78 [95% CI, 1.24-2.56]) and carbapenems (risk ratio, 2.13 [95% CI, 1.49-3.06]) during the ICU stay were independent risk factors for ICU-acquired colonization. Importantly, colonized patients were more likely to develop an extended-spectrum beta-lactamase-producing Enterobacteriaceae infection (risk ratio, 49.62 [95% CI, 20.42-120.58]). The sensitivity and specificity of prior colonization to predict subsequent extended-spectrum beta-lactamase-producing Enterobacteriaceae infection were 95.1% (95% CI, 54.7-99.7) and 89.2% (95% CI, 77.2-95.3), respectively. CONCLUSIONS: The ICU acquisition rate of extended-spectrum beta-lactamase-producing Enterobacteriaceae ranged from 5% to 10%. Previous use of beta-lactam/beta-lactamase or carbapenems and recent hospitalization were independent risk factors for extended-spectrum beta-lactamase-producing Enterobacteriaceae colonization, and colonization was associated with significantly higher frequency of extended-spectrum beta-lactamase-producing Enterobacteriaceae subsequent infection and increased mortality.

Appetite suppressants may be one strategy in the fight against obesity. This study evaluated whether Korean pine nut free fatty acids (FFA) and triglycerides (TG) work as an appetite suppressant. Korean pine nut FFA were evaluated in STC-1 cell culture for their ability to increase cholecystokinin (CCK-8) secretion vs. several other dietary fatty acids from Italian stone pine nut fatty acids, oleic acid, linoleic acid, alpha-linolenic acid, and capric acid used as a control. At 50 muM concentration, Korean pine nut FFA produced the greatest amount of CCK-8 release (493 pg/ml) relative to the other fatty acids and control (46 pg/ml). A randomized, placebo-controlled, double-blind cross-over trial including 18 overweight post-menopausal women was performed. Subjects received capsules with 3 g Korean pine (Pinus koraiensis) nut FFA, 3 g pine nut TG or 3 g placebo (olive oil) in combination with a light breakfast. At 0, 30, 60, 90, 120, 180 and 240 minutes the gut hormones cholecystokinin (CCK-8), glucagon like peptide-1 (GLP-1), peptide YY (PYY) and ghrelin, and appetite sensations were measured. A wash-out period of one week separated each intervention day.CCK-8 was higher 30 min after pine nut FFA and 60 min after pine nut TG when compared to placebo (p < 0.01). GLP-1 was higher 60 min after pine nut FFA compared to placebo (p < 0.01). Over a period of 4 hours the total amount of plasma CCK-8 was 60% higher after pine nut FFA and 22% higher after pine nut TG than after placebo (p < 0.01). For GLP-1 this difference was 25% after pine nut FFA (P < 0.05). Ghrelin and PYY levels were not different between groups. The appetite sensation "prospective food intake" was 36% lower after pine nut FFA relative to placebo (P < 0.05). This study suggests that Korean pine nut may work as an appetite suppressant through an increasing effect on satiety hormones and a reduced prospective food intake.

Abstract During the last two decades, a number of methods have been developed and evaluated for selecting the optimal number of components in a PLS model. In this paper, a new method is introduced that is based on a randomization test. The advantage of using a randomization test is that in contrast to cross validation (CV), it requires no exclusion of data, thus avoiding problems related to data exclusion, for example in designed experiments. The method is tested using simulated data sets for which the true dimensionality is clearly defined and also compared to regularly used methods for 10 real data sets. The randomization test works as a good statistical selection tool in combination with other selection rules. It also works as an indicator when the data require a pre‐treatment. Copyright © 2007 John Wiley &amp; Sons, Ltd.