ResearchPad - research-assessment https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Fruit and vegetable consumption in Europe according to gender, educational attainment and regional affiliation—A cross-sectional study in 21 European countries]]> https://www.researchpad.co/article/elastic_article_13846 The purpose of the present study was to examine fruit and vegetable consumption according to gender, educational attainment and regional affiliation in Europe.DesignCross-sectional study.Setting21 European countries.Participants37 672 adults participating in the 7th round of the European Social Survey.Main outcome measuresFruit and vegetable consumption was measured using two single frequency questions. Responses were dichotomized into low (<once a day) and high (≥once a day) consumption. The association between consumption of fruit and vegetables and gender, educational level, regional affiliation was examined using logistic regression analyses.ResultsOverall, females showed increased odds of consuming fruit (OR 1.71 (95%CI:1.62, 1.79) and vegetable (1.59 (1.51, 1.67)) compared to males and high educated participants showed increased odds of consuming fruit (1.53 (1.43, 1.63)) and vegetables (1.86 (1.74, 2.00)) compared to low educated participants. Our results also showed that participants living in Eastern Europe had the lowest odds of consuming fruit and vegetables, whereas participants from Southern- and Northern Europe had the highest odds of consuming fruit and vegetables, respectively. Results from interaction analyses confirmed the positive association between fruit and vegetable consumption and educational level, although for some European regions, decreased odds of fruit and vegetables was observed among medium educated participants compared to those with low education.ConclusionsOverall, the present study showed that being female and having a high education were associated with increased consumption of fruit and vegetables. However, the direction and strength of these relationships depends on regional affiliations. ]]> <![CDATA[What makes an effective grants peer reviewer? An exploratory study of the necessary skills]]> https://www.researchpad.co/article/elastic_article_13869 This exploratory mixed methods study describes skills required to be an effective peer reviewer as a member of review panels conducted for federal agencies that fund research, and examines how reviewer experience and the use of technology within such panels impacts reviewer skill development. Two specific review panel formats are considered: in-person face-to-face and virtual video conference. Data were collected through interviews with seven program officers and five expert peer review panelists, and surveys from 51 respondents. Results include the skills reviewers’ consider necessary for effective review panel participation, their assessment of the relative importance of these skills, how they are learned, and how review format affects skill development and improvement. Results are discussed relative to the peer review literature and with consideration of the importance of professional skills needed by successful scientists and peer reviewers.

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<![CDATA[A network analysis of research productivity by country, discipline, and wealth]]> https://www.researchpad.co/article/elastic_article_13855 Research productivity has been linked to a country’s intellectual and economic wealth. Further analysis is needed to assess the association between the distribution of research across disciplines and the economic status of countries.MethodsBy using 55 years of data, spanning 1962 to 2017, of Elsevier publications across a large set of research disciplines and countries globally, this manuscript explores the relationship and evolution of relative research productivity across different disciplines through a network analysis. It also explores the associations of those with economic productivity categories, as measured by the World Bank economic classification. Additional analysis of discipline similarities is possible by exploring the cross-country evolution of those disciplines.ResultsResults show similarities in the relative importance of research disciplines among most high-income countries, with larger idiosyncrasies appearing among the remaining countries. This group of high-income countries shows similarities in the dynamics of the relative distribution of research productivity over time, forming a stable research productivity cluster. Lower income countries form smaller, more independent and evolving clusters, and differ significantly from each other and from higher income countries in the relative importance of their research emphases. Country-based similarities in research productivity profiles also appear to be influenced by geographical proximity.ConclusionsThis new form of analyses of research productivity, and its relation to economic status, reveals novel insights to the dynamics of the economic and research structure of countries. This allows for a deeper understanding of the role a country’s research structure may play in shaping its economy, and also identification of benchmark resource allocations across disciplines for developing countries. ]]> <![CDATA[Operational method of reliability and content-validity analysis: Taking “trait-symptoms” screening of individuals at high-risk for OCD as an example]]> https://www.researchpad.co/article/elastic_article_13806 A well-designed self-reported scale is highly applicable to current clinical and research practices. However, the problems with the scale method, such as quantitative analysis of content validity and test-retest reliability analysis of state-like variables are yet to be resolved. The main purpose of this paper is to propose an operational method for solving these problems. Additionally, it aims to enhance understanding of the research paradigm for the scale method (excluding criterion-related validity). This paper used a study that involved screening of high-risk groups for OCD (Obsessive-Compulsive Disorder), conducted 5 rounds of tests, and developed scales, reliability, and validity analysis (using sample sizes of 496, 610, 600, 600 and 990). The operational method we propose is practical, feasible, and can be used to develop and validate a scale.

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<![CDATA[Interventions to improve self-management of adults living with HIV on Antiretroviral Therapy: A systematic review]]> https://www.researchpad.co/article/elastic_article_7726 Since its initial recognition, HIV has been responsible for around 35 million deaths globally. The introduction of Antiretroviral Therapy has helped to reduce mortality from HIV. However, the resulting increased longevity has influenced the experience of people living with HIV, which now manifests as a chronic condition requiring effective self-management. This review aimed to identify and evaluate the effectiveness of interventions to improve self-management of adults living with HIV on Antiretroviral therapy.MethodsThe review included published experimental studies addressing interventions to improve self-management of adults living with HIV on Antiretroviral Therapy. Studies were included if they addressed two or more outcomes of self-management, as defined by the Theory of Individual and Family Self-Management. The search covered four databases and was limited to papers published in the English language from 2001 to March 30, 2019. The reference lists of included studies were further searched for additional studies. Two independent reviewers using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI SUMARI) assessed the methodological quality of the reviewed papers. Data extraction was undertaken using the JBI SUMARI standardized data extraction tool. As the included papers were not homogeneous, it was not possible to conduct a meta-analysis. A narrative synthesis was undertaken to synthesize the findings of the included studies.ResultsThe search identified 337 articles from which 10 experimental and 2 quasi-experimental studies were included. The total participant sample in the included studies was 1661 adults living with HIV. The overall evidence quality of the findings was considered moderate. Many of the studies included in this review comprised multi-component interventions to improve self-management. Skills training, in conjunction with other forms of interventions, particularly phone counseling, was commonly employed and generally effective in improving self-management outcomes. Counseling with a symptom management manual was another employed and effective intervention, followed by technology-assisted self-management interventions. The most common outcomes measured were maintaining medication adherence and quality of life, followed by symptom management, self-efficacy, coping, and social support.ConclusionsInterventions to improve self-management varied across studies. However, promising outcomes achieved in the majority of studies through interventions comprising a combination of skills training, phone counseling, counseling with symptom management manuals, and technology-assisted interventions. ]]> <![CDATA[Prevalence, Severity and Mortality associated with COPD and Smoking in patients with COVID-19: A Rapid Systematic Review and Meta-Analysis]]> https://www.researchpad.co/article/elastic_article_7662 Coronavirus disease 2019 (COVID-19) is an evolving infectious disease that dramatically spread all over the world in the early part of 2020. No studies have yet summarized the potential severity and mortality risks caused by COVID-19 in patients with chronic obstructive pulmonary disease (COPD), and we update information in smokers.MethodsWe systematically searched electronic databases from inception to March 24, 2020. Data were extracted by two independent authors in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Study quality was assessed using a modified version of the Newcastle-Ottawa Scale. We synthesized a narrative from eligible studies and conducted a meta-analysis using a random-effects model to calculate pooled prevalence rates and 95% confidence intervals (95%CI).ResultsIn total, 123 abstracts were screened and 61 full-text manuscripts were reviewed. A total of 15 studies met the inclusion criteria, which included a total of 2473 confirmed COVID-19 patients. All studies were included in the meta-analysis. The crude case fatality rate of COVID-19 was 7.4%. The pooled prevalence rates of COPD patients and smokers in COVID-19 cases were 2% (95% CI, 1%–3%) and 9% (95% CI, 4%–14%) respectively. COPD patients were at a higher risk of more severe disease (risk of severity = 63%, (22/35) compared to patients without COPD 33.4% (409/1224) [calculated RR, 1.88 (95% CI, 1.4–2.4)]. This was associated with higher mortality (60%). Our results showed that 22% (31/139) of current smokers and 46% (13/28) of ex-smokers had severe complications. The calculated RR showed that current smokers were 1.45 times more likely [95% CI: 1.03–2.04] to have severe complications compared to former and never smokers. Current smokers also had a higher mortality rate of 38.5%.ConclusionAlthough COPD prevalence in COVID-19 cases was low in current reports, COVID-19 infection was associated with substantial severity and mortality rates in COPD. Compared to former and never smokers, current smokers were at greater risk of severe complications and higher mortality rate. Effective preventive measures are required to reduce COVID-19 risk in COPD patients and current smokers. ]]> <![CDATA[Class enumeration false positive in skew-t family of continuous growth mixture models]]> https://www.researchpad.co/article/Ne0623f60-4058-4fc0-9606-ac0f597752dc

Growth Mixture Modeling (GMM) has gained great popularity in the last decades as a methodology for longitudinal data analysis. The usual assumption of normally distributed repeated measures has been shown as problematic in real-life data applications. Namely, performing normal GMM on data that is even slightly skewed can lead to an over selection of the number of latent classes. In order to ameliorate this unwanted result, GMM based on the skew t family of continuous distributions has been proposed. This family of distributions includes the normal, skew normal, t, and skew t. This simulation study aims to determine the efficiency of selecting the “true” number of latent groups in GMM based on the skew t family of continuous distributions, using fit indices and likelihood ratio tests. Results show that the skew t GMM was the only model considered that showed fit indices and LRT false positive rates under the 0.05 cutoff value across sample sizes and for normal, and skewed and kurtic data. Simulation results are corroborated by a real educational data application example. These findings favor the development of practical guides of the benefits and risks of using the GMM based on this family of distributions.

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<![CDATA[Drug induced pancreatitis: A systematic review of case reports to determine potential drug associations]]> https://www.researchpad.co/article/N8c4889da-2d62-467b-8b66-b271dff2cf8d

Objective

A current assessment of case reports of possible drug-induced pancreatitis is needed. We systematically reviewed the case report literature to identify drugs with potential associations with acute pancreatitis and the burden of evidence supporting these associations.

Methods

A protocol was developed a priori (PROSPERO CRD42017060473). We searched MEDLINE, Embase, the Cochrane Library, and additional sources to identify cases of drug-induced pancreatitis that met accepted diagnostic criteria of acute pancreatitis. Cases caused by multiple drugs or combination therapy were excluded. Established systematic review methods were used for screening and data extraction. A classification system for associated drugs was developed a priori based upon the number of cases, re-challenge, exclusion of non-drug causes of acute pancreatitis, and consistency of latency.

Results

Seven-hundred and thirteen cases of potential drug-induced pancreatitis were identified, implicating 213 unique drugs. The evidence base was poor: exclusion of non-drug causes of acute pancreatitis was incomplete or poorly reported in all cases, 47% had at least one underlying condition predisposing to acute pancreatitis, and causality assessment was not conducted in 81%. Forty-five drugs (21%) were classified as having the highest level of evidence regarding their association with acute pancreatitis; causality was deemed to be probable or definite for 19 of these drugs (42%). Fifty-seven drugs (27%) had the lowest level of evidence regarding an association with acute pancreatitis, being implicated in single case reports, without exclusion of other causes of acute pancreatitis.

Discussion

Much of the case report evidence upon which drug-induced pancreatitis associations are based is tenuous. A greater emphasis on exclusion of all non-drug causes of acute pancreatitis and on quality reporting would improve the evidence base. It should be recognized that reviews of case reports, are valuable scoping tools but have limited strength to establish drug-induced pancreatitis associations.

Registration

CRD42017060473.

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<![CDATA[Association between boarding in the emergency department and in-hospital mortality: A systematic review]]> https://www.researchpad.co/article/N48ef4c13-827b-4694-911d-7d7581473712

Importance

Boarding in the emergency department (ED) is a critical indicator of quality of care for hospitals. It is defined as the time between the admission decision and departure from the ED. As a result of boarding, patients stay in the ED until inpatient beds are available; moreover, boarding is associated with various adverse events.

Study objective

The objective of our systematic review was to determine whether ED boarding (EDB) time is associated with in-hospital mortality (IHM).

Methods

A systematic search was conducted in academic databases to identify relevant studies. Medline, PubMed, Scopus, Embase, Cochrane, Web of Science, Cochrane, CINAHL and PsychInfo were searched. We included all peer-reviewed published studies from all previous years until November 2018. Studies performed in the ED and focused on the association between EDB and IHM as the primary objective were included. Extracted data included study characteristics, prognostic factors, outcomes, and IHM. A search update in PubMed was performed in May 2019 to ensure the inclusion of recent studies before publishing.

Results

From the initial 4,321 references found through the systematic search, the manual screening of reference lists and the updated search in PubMed, a total of 12 studies were identified as eligible for a descriptive analysis. Overall, six studies found an association between EDB and IHM, while five studies showed no association. The last remaining study included both ICU and non-ICU subgroups and showed conflicting results, with a positive association for non-ICU patients but no association for ICU patients. Overall, a tendency toward an association between EDB and IHM using the pool random effect was observed.

Conclusion

Our systematic review did not find a strong evidence for the association between ED boarding and IHM but there is a tendency toward this association. Further well-controlled, international multicenter studies are needed to demonstrate whether this association exists and whether there is a specific EDB time cut-off that results in increased IHM.

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<![CDATA[Reporting quality and spin in abstracts of randomized clinical trials of periodontal therapy and cardiovascular disease outcomes]]> https://www.researchpad.co/article/N5a52c97b-59d0-4564-8bd9-d8b1530b3570

Objective

Poor reporting in randomized clinical trial (RCT) abstracts reduces quality and misinforms readers. Spin, a biased presentation of findings, could frequently mislead clinicians to accept a clinical intervention despite non-significant primary outcome. Therefore, good reporting practices and absence of spin enhances research quality. We aim to assess the reporting quality and spin in abstracts of RCTs evaluating the effect of periodontal therapy on cardiovascular (CVD) outcomes.

Methods

PubMed, Scopus, the Cochrane Central Register of Controlled Trials (CENTRAL), and 17 trial registration platforms were searched. Cohort, non-randomized, non-English studies, and pediatric studies were excluded. RCT abstracts were reviewed by 2 authors using the CONSORT for abstracts and spin checklists for data extraction. Cohen’s Kappa statistic was used to assess inter-rater agreement. Data on the selected RCT publication metrics were collected. Descriptive analysis was performed with non-parametric methods. Correlation analysis between quality, spin and bibliometric parameters was conducted.

Results

24 RCTs were selected for CONSORT analysis and 14 fulfilled the criteria for spin analysis. Several important RCT elements per CONSORT were neglected in the abstract including description of the study population (100%), explicitly stated primary outcome (87%), methods of randomization and blinding (100%), trial registration (87%). No RCT examined true outcomes (CVD events). A significant fraction of the abstracts appeared with at least one form of spin in the results and conclusions (86%) and claimed some treatment benefit in spite of non-significant primary outcome (64%). High-quality reporting had a significant positive correlation with reporting of trial registration (p = 0.04) and funding (p = 0.009). Spinning showed marginal negative correlation with reporting quality (p = 0.059).

Conclusion

Poor adherence to the CONSORT guidelines and high levels of data spin were found in abstracts of RCTs exploring the effects of periodontal therapy on CVD outcomes. Our findings indicate that journal editors and reviewers should consider strict adherence to proper reporting guidelines to improve reporting quality and reduce waste.

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<![CDATA[Psychometric characteristics and factorial structures of the Defensive Pessimism Questionnaire—Spanish Version (DPQ-SV)]]> https://www.researchpad.co/article/Nb6dcc03f-c5ae-4fce-8b03-b30a02ab227b

The aim of this study was to validate the Spanish version of the Defensive Pessimism Questionnaire. A sample of undergraduate students (N = 539) was measured on defensive pessimism using the Defensive Pessimism Questionnaire (DPQ), optimism and pessimism using the Life Orientation Test (LOT), positive and negative affect using the Positive and Negative Affect Schedule, and anxiety using the trait subscale of the State and Trait Anxiety Inventory. A Spanish version of the DPQ (DPQ-SV) is presented. Exploratory and Robust Confirmatory Factor Analysis had a bi-dimensional structure (Reflectivity and Negative Expectation). Omega coefficient showed a high internal consistency and the temporal stability was high in each dimension. Both DPQ-SV subscales (Negative Expectation and Reflectivity) showed adequate convergence with LOT-optimism and LOT-pessimism. Reflectivity showed adequate criterion validity with trait-anxiety and negative affect, but inadequate criterion validity with positive affect. Negative Expectation showed excellent criterion validity with trait-anxiety and negative affect and good criterion validity with positive affect. Finally, mediation analysis showed that Negative Expectation had a significant indirect mediating effect between trait-anxiety and negative affect. Reflectivity had a significant indirect mediating effect between trait-anxiety and negative and positive affect. Analysis of the psychometric properties of the DPQ-SV subscale scores showed that it is a two factor adequate measurement tool for its use in this type of samples.

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<![CDATA[Is bad news on TV tickers good news? The effects of voiceover and visual elements in video on viewers’ assessment]]> https://www.researchpad.co/article/N6a76f847-8cb5-45f6-9e66-865fc26387f0

In our experiment, we tested how exposure to a mock televised news segment, with a systematically manipulated emotional valence of voiceover, images and TV tickers (in the updating format) impacts viewers’ perception. Subjects (N = 603) watched specially prepared professional video material which portrayed the story of a candidate for local mayor. Following exposure to the video, subjects assessed the politician in terms of competence, sociability, and morality.

Results showed that positive images improved the assessment of the politician, whereas negative images lowered it. In addition, unexpectedly, positive tickers led to a negative assessment, and negative ones led to more beneficial assessments. However, in a situation of inconsistency between the voiceover and information provided on visual add-ons, additional elements are apparently ignored, especially when they are negative and the narrative is positive. We then discuss the implications of these findings.

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<![CDATA[Is it time to stop sweeping data cleaning under the carpet? A novel algorithm for outlier management in growth data]]> https://www.researchpad.co/article/N6ac4201b-e1d9-4dac-b706-1c6b88e127a6

All data are prone to error and require data cleaning prior to analysis. An important example is longitudinal growth data, for which there are no universally agreed standard methods for identifying and removing implausible values and many existing methods have limitations that restrict their usage across different domains. A decision-making algorithm that modified or deleted growth measurements based on a combination of pre-defined cut-offs and logic rules was designed. Five data cleaning methods for growth were tested with and without the addition of the algorithm and applied to five different longitudinal growth datasets: four uncleaned canine weight or height datasets and one pre-cleaned human weight dataset with randomly simulated errors. Prior to the addition of the algorithm, data cleaning based on non-linear mixed effects models was the most effective in all datasets and had on average a minimum of 26.00% higher sensitivity and 0.12% higher specificity than other methods. Data cleaning methods using the algorithm had improved data preservation and were capable of correcting simulated errors according to the gold standard; returning a value to its original state prior to error simulation. The algorithm improved the performance of all data cleaning methods and increased the average sensitivity and specificity of the non-linear mixed effects model method by 7.68% and 0.42% respectively. Using non-linear mixed effects models combined with the algorithm to clean data allows individual growth trajectories to vary from the population by using repeated longitudinal measurements, identifies consecutive errors or those within the first data entry, avoids the requirement for a minimum number of data entries, preserves data where possible by correcting errors rather than deleting them and removes duplications intelligently. This algorithm is broadly applicable to data cleaning anthropometric data in different mammalian species and could be adapted for use in a range of other domains.

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<![CDATA[Would you like to participate in this trial? The practice of informed consent in intrapartum research in the last 30 years]]> https://www.researchpad.co/article/Na45ec8a9-d35b-4ecd-a654-0f10371697fd

Background

Informed consent is the cornerstone of the ethical conduct and protection of the rights and wellbeing of participants in clinical research. Therefore, it is important to identify the most appropriate moments for the participants to be informed and to give consent, so that they are able to make a responsible and autonomous decision. However, the optimal timing of consent in clinical research during the intrapartum period remains controversial, and currently, there is no clear guidance.

Objective

We aimed to describe practices of informed consent in intrapartum care clinical research in the last three decades, as reported in uterotonics for postpartum haemorrhage prevention trials.

Methods

This is a secondary analysis of the studies included in the Cochrane review entitled “Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis” published in 2018. All the reports included in the Cochrane network meta-analysis were eligible for inclusion in this analysis, except for those reported in languages other than English, French or Spanish. We extracted and synthesized data on the time each of the components of the informed consent process occurred.

Results

We assessed data from 192 studies, out of 196 studies included in the Cochrane review. The majority of studies (59.9%, 115 studies) reported that women were informed about the study, without specifying the timing. When reported, most studies informed women at admission to the facility for childbirth. Most of the studies reported that consent was sought, but only 59.9% reported the timing, which in most of the cases, was at admission for childbirth. Among these, 32 studies obtained consent in the active phase of labour, 17 in the latent phase and in 10 studies the labour status was unknown. Women were consented antenatally in 6 studies and in 8 studies the consent was obtained indistinctly during antenatal care or at admission. Most of the studies did not specified who was the person who sought the informed consent.

Conclusion

Practices of informed consent in trials on use of uterotonics for prevention of postpartum haemorrhage showed variability and substandard reporting. Informed consent sought at admission for childbirth was the most frequent approach implemented in these trials.

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<![CDATA[Retraction: DJ-1 Modulates α-Synuclein Aggregation State in a Cellular Model of Oxidative Stress: Relevance for Parkinson's Disease and Involvement of HSP70]]> https://www.researchpad.co/article/N05d3b52b-2e52-4bb2-9470-b0dedbc652af ]]> <![CDATA[pyKNEEr: An image analysis workflow for open and reproducible research on femoral knee cartilage]]> https://www.researchpad.co/article/N0686bd46-1746-4f66-8610-270f1b75b482

Transparent research in musculoskeletal imaging is fundamental to reliably investigate diseases such as knee osteoarthritis (OA), a chronic disease impairing femoral knee cartilage. To study cartilage degeneration, researchers have developed algorithms to segment femoral knee cartilage from magnetic resonance (MR) images and to measure cartilage morphology and relaxometry. The majority of these algorithms are not publicly available or require advanced programming skills to be compiled and run. However, to accelerate discoveries and findings, it is crucial to have open and reproducible workflows. We present pyKNEEr, a framework for open and reproducible research on femoral knee cartilage from MR images. pyKNEEr is written in python, uses Jupyter notebook as a user interface, and is available on GitHub with a GNU GPLv3 license. It is composed of three modules: 1) image preprocessing to standardize spatial and intensity characteristics; 2) femoral knee cartilage segmentation for intersubject, multimodal, and longitudinal acquisitions; and 3) analysis of cartilage morphology and relaxometry. Each module contains one or more Jupyter notebooks with narrative, code, visualizations, and dependencies to reproduce computational environments. pyKNEEr facilitates transparent image-based research of femoral knee cartilage because of its ease of installation and use, and its versatility for publication and sharing among researchers. Finally, due to its modular structure, pyKNEEr favors code extension and algorithm comparison. We tested our reproducible workflows with experiments that also constitute an example of transparent research with pyKNEEr, and we compared pyKNEEr performances to existing algorithms in literature review visualizations. We provide links to executed notebooks and executable environments for immediate reproducibility of our findings.

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<![CDATA[Exponential random graph model parameter estimation for very large directed networks]]> https://www.researchpad.co/article/N437fb42a-ebf8-44aa-9399-d12b1354408e

Exponential random graph models (ERGMs) are widely used for modeling social networks observed at one point in time. However the computational difficulty of ERGM parameter estimation has limited the practical application of this class of models to relatively small networks, up to a few thousand nodes at most, with usually only a few hundred nodes or fewer. In the case of undirected networks, snowball sampling can be used to find ERGM parameter estimates of larger networks via network samples, and recently published improvements in ERGM network distribution sampling and ERGM estimation algorithms have allowed ERGM parameter estimates of undirected networks with over one hundred thousand nodes to be made. However the implementations of these algorithms to date have been limited in their scalability, and also restricted to undirected networks. Here we describe an implementation of the recently published Equilibrium Expectation (EE) algorithm for ERGM parameter estimation of large directed networks. We test it on some simulated networks, and demonstrate its application to an online social network with over 1.6 million nodes.

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<![CDATA[Acute kidney injury and adverse renal events in patients receiving SGLT2-inhibitors: A systematic review and meta-analysis]]> https://www.researchpad.co/article/N25fa93a0-706a-4469-9476-c6f8ced4ff6a

Background

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) represent a new class of oral hypoglycemic agents used in the treatment of type 2 diabetes mellitus. They have a positive effect on the progression of chronic kidney disease, but there is a concern that they might cause acute kidney injury (AKI).

Methods and findings

We conducted a systematic review and meta-analysis of the effect of SGLT2is on renal adverse events (AEs) in randomized controlled trials and controlled observational studies. PubMed, EMBASE, Cochrane library, and ClinicalTrials.gov were searched without date restriction until 27 September 2019. Data extraction was performed using a standardized data form, and any discrepancies were resolved by consensus. One hundred and twelve randomized trials (n = 96,722) and 4 observational studies with 5 cohorts (n = 83,934) with a minimum follow-up of 12 weeks that provided information on at least 1 adverse renal outcome (AKI, combined renal AE, or hypovolemia-related events) were included. In 30 trials, 410 serious AEs due to AKI were reported. SGLT2is reduced the odds of suffering AKI by 36% (odds ratio [OR] 0.64 [95% confidence interval (CI) 0.53–0.78], p < 0.001). A total of 1,089 AKI events of any severity (AEs and serious AEs [SAEs]) were published in 41 trials (OR 0.75 [95% CI 0.66–0.84], p < 0.001). Empagliflozin, dapagliflozin, and canagliflozin had a comparable benefit on the SAE and AE rate. AEs related to hypovolemia were more commonly reported in SGLT2i-treated patients (OR 1.20 [95% CI 1.10–1.31], p < 0.001). In the observational studies, 777 AKI events were reported. The odds of suffering AKI were reduced in patients receiving SGLT2is (OR 0.40 [95% CI 0.33–0.48], p < 0.001). Limitations of this study are the reliance on nonadjudicated safety endpoints, discrepant inclusion criteria and baseline hypoglycemic therapy between studies, inconsistent definitions of renal AEs and hypovolemia, varying follow-up times in different studies, and a lack of information on the severity of AKI (stages I–III).

Conclusions

SGLT2is reduced the odds of suffering AKI with and without hospitalization in randomized trials and the real-world setting, despite the fact that more AEs related to hypovolemia are reported.

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<![CDATA[Withdrawn medicines included in the essential medicines lists of 136 countries]]> https://www.researchpad.co/article/Nfc60a8e8-cffd-4562-8a11-e8128980c61b

Background

Essential medicines lists and related policies are intended to meet the priority health needs of populations and their implementation is associated with more appropriate use of medicines. The World Health Organization (WHO) recommends that countries carefully select the medicines to be included in their national essential medicines lists. Lists that are used to prioritize access to important treatments should not include medicines that have been withdrawn elsewhere because of an unfavourable benefit-to-harm balance; however, countries still list and use medicines that have been withdrawn worldwide. The objective of this study was to determine whether the national essential medicines lists of 137 countries include medicines that have been withdrawn in other countries.

Methods and findings

We performed an audit of national essential medicines lists for medicines that had been withdrawn. Medicines withdrawn from worldwide markets between 1953 and 2014 were identified using a systematic review of published literature and regulatory documents. The reviewers used sources including the WHO’s database of drugs, PubMed, and the websites of regulatory agencies to obtain information regarding adverse effects associated with the medicines, the year of first withdrawal, markets of withdrawal, and the level of evidence supporting each withdrawal. We recorded the number of countries with a withdrawn medicine included in their national medicines list, the number of withdrawn medicines included in each nation’s list, and the number of national essential medicines including each withdrawn medicine. 97 medicines were withdrawn in at least one country but still included in one more national essential medicines list. Of 137 countries with a national essential medicines list, 136 lists included at least one withdrawn medicine, with 54% of the lists containing 5 or fewer withdrawn medicines, and 27% including 10 or more withdrawn medicines. 11 medicines were withdrawn worldwide but still included on at least one national essential medicines list. Countries with longer essential medicines lists had more withdrawn medicines included in their lists.

Conclusions

This study found that withdrawn medicines are included in all but one national essential medicines list, representing a need for more stringent processes for selecting and removing medicines on these lists. Countries may wish to apply special scrutiny to medicines withdrawn in other nations when selecting medicines to include on their lists.

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<![CDATA[The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation]]> https://www.researchpad.co/article/5c8823c4d5eed0c484638faf

Objective

Valid, reliable, and clinically relevant outcome measures are necessary in clinical studies of snake envenomation. The aim of this study was to evaluate the psychometric (validity and reliability) and clinimetric (minimal clinically important difference [MCID]) properties of the Patient-Specific Functional Scale (PSFS) in snakebite envenomation.

Methods

We performed a secondary analysis of two existing snakebite trials that measured clinical outcomes using the PSFS as well as other quality of life and functional assessments. Data were collected at 3, 7, 10, and 17 days. Reliability was determined using Cronbach’s alpha for internal consistency and the intraclass correlation coefficient (ICC) for temporal stability at 10 and 17 days. Validity was assessed using concurrent validity correlating with the other assessments. The MCID was evaluated using the following criteria: (1) the distribution of stable patients according to both standard error of measurement (SEM) and responsiveness techniques, and (2) anchor-based methods to compare between individuals and to detect discriminant ability of a positive change with a receiver operator characteristic (ROC) curve and optimal cutoff point.

Results

A total of 86 patients were evaluated in this study. The average PSFS scores were 5.37 (SD 3.23), 7.95 (SD 2.22), and 9.12 (SD 1.37) at 3, 7, and 10 days, respectively. Negligible floor effect was observed (maximum of 8% at 3 days); however, a ceiling effect was observed at 17 days (25%). The PSFS showed good reliability with an internal consistency of 0.91 (Cronbach’s alpha) (95% CI 0.88, 0.95) and a temporal stability of 0.83 (ICC) (95% CI 0.72, 0.89). The PSFS showed a strong positive correlation with quality of life and functional assessments. The MCID was approximately 1.0 for all methods.

Conclusions

With an MCID of approximately 1 point, the PSFS is a valid and reliable tool to assess quality of life and functionality in patients with snake envenomation.

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