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Setting Inclusion and Exclusion Criteria

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Abstract

After retrieving studies and sources based on the review question, see Chapter 4, and the search strategy, see Chapter 5, the next step is considering which sources to include and which ones to exclude.

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... Further articles were identified by reviewing the reference list. To ensure a meaningful comparison, only full-text or peer-reviewed journal articles were chosen to form selected journal articles (Dekkers et al., 2022). Besides that, the selection of the journal articles was limited to those published between 2019 to 2023 were considered. ...
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The purpose of this systematic review is to conduct a comprehensive analysis of existing literature that explores various gamification techniques, interventions, and principles employed in teaching and enhancing a spectrum of writing skills. The review analyzes interventions that employ full gamification or selective game components to improve writing competency among students specifically, to improve writing, identify the types of gamification techniques in terms of enhancing writing competency among students and examine the age group that is often exposed to gamification techniques in improving writing. The study follows a 5-phase model by Khalid Saeed Khan and collects journal articles from ERIC and Google Scholar published between 2019-2023. The results of the study show a preference for incorporating game elements into writing activities, either through full gamification or selective game components which led to an increase in students' motivation and engagement. The study aims to provide insights into the effectiveness of gamification strategies in enhancing writing skills and identify the most effective strategies for different learners and contexts.
... Dekkers et al. [18] explain that having eligibility criteria enables one to set boundaries for the types of studies that can be included in the literature review. Inclusion and exclusion criteria are set after identifying the research question but before the actual literature review [19]. ...
... Additionally, studies presenting empirical data, such as laboratory experiments, field studies, or case reports, were considered for inclusion. Papers available in English were included to ensure accessibility and uniform interpretation (Almıla, 2022;Dekkers et al., 2022). Exclusion ...
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The persistence of PAHs poses a significant challenge for conventional remediation approaches, necessitating the exploration of alternative, sustainable strategies for their mitigation. This review underscores the vital role of specialized microbial species (nitrogen-fixing, phosphate-solubilizing, and biosurfactant-producing bacteria) in tackling the environmental impact of polycyclic aromatic hydrocarbons (PAHs). These resistant compounds demand innovative remediation strategies. The study explores microbial metabolic capabilities for converting complex PAHs into less harmful byproducts, ensuring sustainable mitigation. Synthesizing literature from 2016 to 2023, it covers PAH characteristics, sources, and associated risks. Degradation mechanisms by bacteria and fungi, key species, and enzymatic processes are examined. Nitrogen-fixing and phosphate-solubilizing bacteria contributions in symbiotic relationships with plants are highlighted. Biosurfactant-producing bacteria enhance PAH solubility, expanding microbial accessibility for degradation. Cutting-edge trends in omics technologies, synthetic biology, genetic engineering, and nano-remediation offer promising avenues. Recommendations emphasize genetic regulation, field-scale studies, sustainability assessments, interdisciplinary collaboration, and knowledge dissemination. These insights pave the way for innovative, sustainable PAH-contaminated environment restoration.
... The provision of the inclusion and Fig. 2. Out-of-plane failure with failure plane: (a) parallel to bed joints, (b) perpendicular to bed joints [4]. exclusion criteria is very important to restrict the search outcomes to the most relevant literatures [24]. Language and document type are the two main exclusion criteria imposed in this study. ...
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The assessment of unreinforced masonry (URM) walls often involves experimental characterisation of their in-plane (IP) and out-of-plane (OOP) failure. While IP and OOP testing of URM walls is common, standardised testing methods are lacking, resulting in varied approaches. This study thus presents a systematic review of 54 selected articles to examine different masonry testing procedures through an analysis of specimen characterisation, testing arrangements, loading rate and failure patterns across various studies. The review highlights disparities in experimental approaches and stresses the necessity for uniform testing procedures or standardisation protocol to ensure consistency and reliability. Significantly the review identifies a tendency to overlook real-world scenarios in testing, emphasising the importance of addressing this gap for comprehensive assessment of masonry walls. The study thus recommends further experimental studies on the effect of openings on walls and the interaction between masonry walls and the slabs/connections with other walls/ring beams to enrich masonry behaviour understanding through both experimental and numerical approaches.
... Tis study's inclusion criteria were as follows: (a) all professional nurses in the chosen private hospitals caring for patients in COVID-19 ICUs during the pandemic; (b) the professional nurses had to be permanently employed at one of the fve private hospitals, working day or night shifts in the COVID-19 ICUs; (c) participants had to be able to read and speak English; and (d) professional nurses who are working in the COVID-19 ICUs. Exclusion criteria are characteristics that restrict the population to a homogenous group of subjects [46]. Tis study's exclusion criteria were as follows: (a) professional nurses who did not work in the COVID-19 ICUs full time or those working as agency staf as they were often unavailable; (b) enrolled and auxiliary nurses working in the COVID-19 ICUs and general units, as they work under the direct supervision of professional nurses, and they were not assigned to nurse critically ill patients; and (c) professional nurses working in the general COVID-19 wards. ...
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Aim To explore and describe intensive care professional nurses' experiences caring for COVID-19 patients in private hospitals in Gauteng, South Africa. Introduction Pandemics are unique forms of disasters characterised by adverse psychological symptoms and behaviours. Literature confirms a globally increased workload during pandemics, causing emotional exhaustion and poor concentration among healthcare workers. Moreover, high mortality rates are mentioned as a cause of moral distress and moral injury to healthcare workers. South Africa was unprepared for the COVID-19 pandemic, as evidenced by overcrowded hospitals, a lack of resources, and high mortality rates. Materials and Methods A qualitative, phenomenological, exploratory, descriptive, and contextual research design was used. The five largest private hospitals from the same hospital group in Gauteng were chosen as they were admitting many COVID-19 patients. Fifteen participants were selected through purposeful sampling. Semistructured, in-depth, individual interviews were conducted and audio-recorded, and field notes were taken from April 2022 to December 2022. The interviews were transcribed verbatim and analysed using Giorgi's approach. Results Three themes emerged: abrupt transition from normality to the COVID-19 pandemic; experienced isolation from family, community, and nursing management; and feelings of satisfaction and gratitude for teamwork and learning. Conclusions It is essential for nurses' holistic care to be considered along with patients' holistic care. The findings in this study could drive healthcare institutions in South Africa to respond to nurses' health, care, and support needs. Implication for Nursing Management. Nursing management should consider shorter and fewer consecutive workdays for nurses to rest and restore their energy levels. Nurse management should also provide human caring by being visible to the nurses and communicating with them. Holistic self-care practices should be included in nurses' in-service training programmes.
... In the second phase, data collection and filtering of documents is carried out on the basis of a series of inclusion and exclusion criteria. According to Connelly (2020) inclusion criteria are important because they serve as a guide to determine whether a study should be included or excluded. In this sense, exclusion criteria aim to avoid the influence of variables that may condition the results. ...
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Nowadays, education is a fundamental element to provide people with independence and knowledge. All citizens have the right of access to education, including students with special educational needs. Education must be inclusive for these students at primary, secondary and university levels. Therefore, the aim is to analyse the conceptual, intellectual and social structure in the field of inclusive education in the university environment through bibliometric techniques. The sample consisted of 605 documents extracted from the Web of Science and analysed using the bibliometrix software designed in R. The results show that there are two journals that are fundamental in the field and that co-citation networks are generated around them. Furthermore, the most productive authors will occupy central positions. Nonetheless, the papers that initiated the field will receive more citations. Finally, since 2010, a greater diversity of topics within inclusive education can be observed, such as teacher training in inclusive education or considering the curriculum. Future lines of work include the possibility of using more databases and establishing an action protocol based on the results.
... According to Cardona-Arias et al. (2017), the second type may consider the filters of the sources consulted. In this sense, Connelly (2020) assures that the inclusion criteria help researchers to determine whether or not an article should be included in the review sample. The importance of exclusion criteria lies in avoiding the influence of variables in the study. ...
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Nowadays, technology plays a fundamental role in the development of daily life activities. In this regard, there is an increase in disciplines that have used technologies, with educational fields standing out above all. Within education, there are a series of emerging technologies that are increasingly implemented in the classroom. Emerging technologies are also well aligned to autistic students and their specific learning and cognitive preferences. Therefore, the aim of this review is to carry out a systematic and thematic review on the application of Virtual reality (VR) in teaching and learning environments for autistic students during the period 1996–2021. Our analysis located a sample of 38 documents obtained from the WEB of Science and Scopus based on following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidance. Our results highlight that much of the research was focused on areas of emotional recognition and social skills development. In addition, we found that when activities were interactive and realistic within the VR environments, the acceptance of this tool was improved for this specific population.
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In recent years there has been a gradual increase in scientific production on the application of Augmented Reality (AR) in students with Autism Spectrum Disorders (ASD). However, a global picture of the field of study has not been established to allow us to study its evolution. As a result, we propose to analyse conceptually, intellectually and socially the global trends in the application of AR in students with ASD using bibliometric techniques in the Web of Science (WOS) and Scopus. A bibliometric study was implemented with a sample of 88 documents obtained from the Web of Science (WOS) and Scopus during the period 1996–2020. The results show that this is a field with several defined thematic lines: firstly, the inclusion of students with ASD in school. Secondly, the diverse technological tools that allow to improve the AR scenarios and finally the determination of the most worked areas in the ASD. In addition to this, most of the authors work individually, but there are co-citation networks around the most cited papers. This means that, especially in WOS, there are very robust networks. As future lines of research, the possibility of adding new bibliometric software that makes it possible to obtain more bibliometric indicators on the documents is considered.
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Guidelines produced by local, national and international bodies underpin clinical practice and healthcare services worldwide. For guidelines to be based on the best available evidence, it is critical that syntheses of both qualitative and quantitative evidence are used to inform decision‐making. As methods for qualitative evidence syntheses (QES) develop, they are increasingly able to inform health guideline production. However, the process whereby this form of evidence is considered and incorporated tends to be unclear. This systematic review synthesised existing guidance concerning the use of QES in guideline development. Sources published in English that described or prescribed methods for incorporating QES into evidence‐based health guidelines were eligible for inclusion. Seventeen relevant papers were identified. The literature indicates that there is a reasonable consensus about many stages of conducting a QES to inform guideline development. Areas needing further exploration include: the way that committees engage with QES; the usefulness of different QES methodologies; and understanding of how expert committees use evidence. Methods for producing QES for guideline committees tend to be similar to quantitative systematic review methods in terms of searching, quality appraisal, systematic management of data, and presentation of results. While this allows transparency and accountability, it could be argued that it is less ‘true’ to the principles of being led by the data, which are fundamental to most qualitative research. Understanding the process of using QES to produce guidelines is critical to determining their validity and applicability, and to ensure that healthcare provision is based on the best available evidence. This article is protected by copyright. All rights reserved.
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Aims The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group Guidance is widely used to increase the transparency by which evidence is turned into recommendations. Although the process is clearly defined, it may be difficult to use in nursing education and practice because it uses separate terminology and tools to those sometimes used in education, such as those devised by the Critical Appraisal Skills Programme (CASP). This paper aims to show how these tools can be used together. Design Discussion paper. Data sources Documentation from the GRADE Working Group, and the CASP, as of 14 June 2019. Implications for nursing All of the items from the CASP check‐list can be incorporated into GRADE which might allow for wider use of its principles in nursing education and practice. Some additions are required, however, to complete the outcome‐level assessment, these being the consistency of the results and possible publication bias. More details on the extent to which the benefits are worth any harms and costs and different types of inconsistency (heterogeneity) would also be useful. This approach is consistent with the Group's Criteria for determining whether the GRADE approach was used. Conclusion The CASP tool can be used with minor modification to a GRADE‐like manner. This would allow for GRADE to be taught and used in nursing education and transferred to practice. Impact This discussion paper addressed the use of the CASP Randomised Controlled Trial check‐list to undertake GRADE‐like assessments of evidence. With minor modifications to the way CASP is used, it is possible to use this tool to make GRADE‐like assessments of the body of evidence and to critique individual studies. This finding will allow for the full use of the GRADE approach in healthcare education using the CASP tools.
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Background: The evaluation of imprecision is a key dimension of the grading of the confidence in the estimate. Grading of Recommendations Assessment, Development and Evaluation (GRADE) gives recommendations on how to downgrade evidence for imprecision, but authors vary in their use. Trial Sequential Analysis (TSA) has been advocated for a more reliable assessment of imprecision. We aimed to evaluate reporting of and adherence to GRADE and to compare the assessment of imprecision of intervention effects assessed by GRADE and TSA in Cochrane systematic reviews. Methods: In this cross-sectional study, we included 100 Cochrane reviews irrespective of type of intervention with a key dichotomous outcome meta-analyzed and assessed by GRADE. The methods and results sections of each review were assessed for adequacy of imprecision evaluation. We re-analyzed imprecision following the GRADE Handbook and the TSA Manual. Results: Overall, only 13.0% of reviews stated the criteria they applied to assess imprecision. The most common dimensions were the 95% width of the confidence intervals and the optimal information size. Review authors downgraded 48.0% of key outcomes due to imprecision. When imprecision was re-analyzed following the GRADE Handbook, 64% of outcomes were downgraded. Agreement between review authors' assessment and assessment by the authors of this study was moderate (kappa 0.43, 95% confidence interval [CI] 0.23 to 0.58). TSA downgraded 69.0% outcomes due to imprecision. Agreement between review authors' GRADE assessment and TSA, irrespective of downgrading levels, was moderate (kappa 0.43, 95% CI 0.21 to 0.57). Agreement between our GRADE assessment following the Handbook and TSA was substantial (kappa 0.66, 95% CI 0.49 to 0.79). Conclusions: In a sample of Cochrane reviews, methods for assessing imprecision were rarely reported. GRADE according to Handbook guidelines and TSA led to more severe judgment of imprecision rather than GRADE adopted by reviews' authors. Cochrane initiatives to improve adherence to GRADE Handbook are warranted. TSA may transparently assist in such development.
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Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I ("Risk Of Bias In Non-randomised Studies-of Interventions"), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
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Context: Cyber-physical systems (CPS) seamlessly integrate computational and physical components. Adaptability, realized through feedback loops, is a key requirement to deal with uncertain operating conditions in CPS. Objective: We aim at assessing state-of-art approaches to handle self-adaptation in CPS at the architectural level. Method: We conducted a systematic literature review by searching four major scientific data bases, resulting in 1103 candidate studies and eventually retaining 42 primary studies included for data collection after applying inclusion and exclusion criteria. Results: The primary concerns of adaptation in CPS are performance, flexibility, and reliability. 64% of the studies apply adaptation at the application layer and 24% at the middleware layer. MAPE (Monitor-Analyze-Plan-Execute) is the dominant adaptation mechanism (60%), followed by agents and self-organization (both 29%). Remarkably, 36% of the studies combine different mechanisms to realize adaptation; 17% combine MAPE with agents. The dominating application domain is energy (24%). Conclusions: Our findings show that adaptation in CPS is a cross-layer concern, where solutions combine different adaptation mechanisms within and across layers. This raises challenges for future research both in the field of CPS and self-adaptation, including: how to map concerns to layers and adaptation mechanisms, how to coordinate adaptation mechanisms within and across layers, and how to ensure system-wide consistency of adaptation.
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A pyramid has expressed the idea of hierarchy of medical evidence for so long, that not all evidence is the same. Systematic reviews and meta-analyses have been placed at the top of this pyramid for several good reasons. However, there are several counterarguments to this placement. We suggest another way of looking at the evidence-based medicine pyramid and explain how systematic reviews and meta-analyses are tools for consuming evidence - that is, appraising, synthesising and applying evidence. © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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Systematic reviews (SRs) are expected to critically appraise included studies and privilege those at lowest risk of bias (RoB) in the synthesis. This study examines if and how critical appraisals inform the synthesis and interpretation of evidence in SRs. All SRs published in March-May 2012 in 14 high-ranked medical journals and a sample from the Cochrane library were systematically assessed by two reviewers to determine if and how: critical appraisal was conducted; RoB was summarised at study, domain and review levels; and RoB appraisals informed the synthesis process. Of the 59 SRs studied, all except six (90%) conducted a critical appraisal of the included studies, with most using or adapting existing tools. Almost half of the SRs reported critical appraisal in a manner that did not allow readers to determine which studies included in a review were most robust. RoB assessments were not incorporated into synthesis in one-third (20) of the SRs, with their consideration more likely when reviews focused on randomised controlled trials. Common methods for incorporating critical appraisals into the synthesis process were sensitivity analysis, narrative discussion and exclusion of studies at high RoB. Nearly half of the reviews which investigated multiple outcomes and carried out study-level RoB summaries did not consider the potential for RoB to vary across outcomes. The conclusions of the SRs, published in major journals, are frequently uninformed by the critical appraisal process, even when conducted. This may be particularly problematic for SRs of public health topics that often draw on diverse study designs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Background The study objective was to compare the Newcastle–Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs. Methods We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic. Results The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86). Conclusion The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB’s developers.
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Objective: External distraction appears to affect at least 6-9% of distraction-affected motor vehicle collisions. Billboards may be good models for studying external distraction in general, and it is also desirable to understand billboard-related distraction per se. However, there has not yet been a clear consensus on the scope of billboard-related distraction or its dynamics with respect to characteristics of drivers, billboards, traffic, and the roadway. To narrow these knowledge gaps, a systematic literature review was conducted on billboard-related changes in driver visual behavior. Methods: A systematic literature search yielded 443 results, of which 8 studies met all inclusion criteria. Five studies meeting all inclusion criteria were later identified and added. RESULTS were analyzed in terms of 4 categories of visual behavior: (1) gaze variability (GV), glance pattern activity (GPA), and percentage of time spent glancing at the forward roadway; (2) glances at unexpected drive-relevant stimuli; (3) glances at expected drive-relevant stimuli; and (4) glances at billboards. Results: There was considerable evidence that about 10-20% of all glances at billboards were ≥0.75 s, that active billboards drew more glances and more long glances (≥0.75 s, ≥2.0 s) than passive billboards but did not attract a longer average glance, and that there was large variability among individual billboards within categories (e.g., active vs. passive). The extent to which billboards attracted glances ≥ 2.0 s was uncertain. There was tentative evidence that billboards did not affect GPA, glances at expected drive-relevant stimuli, or the proportion of time drivers spent glancing at the forward roadway and that they did affect vertical GV and glances at unexpected drive-relevant stimuli. Conclusions: Generally, billboard-related distraction appeared to be minor and regulated by drivers as the demands of the driving task changed. However, this review's findings suggest that this may not be true in all cases. Future research should emphasize the tails of the distribution in addition to average cases, in terms of both the analysis of visual behavior and the complexity of driving tasks. Further research is also needed to understand the effects of billboard design, driver characteristics, and road and traffic context.
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Purpose The ever changing needs of customers require companies to speed up the new product development process. Thus, the web and social media enable companies to interact and to share knowledge with customers, and to cocreate new products with them. The purpose of this study is to analyze the innovation outputs companies can achieve by involving customers at the “fuzzy front end” of the new product development (NPD) process. Design/methodology/approach A case study method has been adopted because the phenomenon under investigation is new, it is hard to find similar researches, and the study attempts to increase researchers’ understanding of such phenomenon. The case study method has enabled the exploration of the strategies used and the results achieved by an international food company, which has involved ordinary customers at early stages of its NPD process, namely at the idea generation and screening stages. Findings The case study shows that customers freely provide valuable, original, new, and feasible ideas that can foster product and service innovation, and may also trigger process innovation. Thus, the case study shows how the company has outsourced to customers the idea generation and screening stages of the NPD. The case illustrates how the food company has used the ideas gathered from customers to develop new products and new services. Increasingly, it shows also how the company has gathered strategic information about consumers’ needs and desires ( marketing intelligence ). Finally, this research discusses the importance of knowledge codification facilitators and of informal, peer‐to‐peer, and transparent communication as enablers of consumers’ ideas sharing. Research limitations/implications The single case study approach may prevent the generalization of results. Originality/value In marketing and innovation research, there is a dearth of studies on how companies are involving customers through the web at early stages of their NPD process. In addition, there is a lack of in‐depth discussion about the innovation outputs generated through cocreation activities.
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Systematic Reviews (SRs) of experimental animal studies are not yet common practice, but awareness of the merits of conducting such SRs is steadily increasing. As animal intervention studies differ from randomized clinical trials (RCT) in many aspects, the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies. The Cochrane Collaboration developed a Risk of Bias (RoB) tool to establish consistency and avoid discrepancies in assessing the methodological quality of RCTs. A similar initiative is warranted in the field of animal experimentation. We provide an RoB tool for animal intervention studies (SYRCLE's RoB tool). This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies. To enhance transparency and applicability, we formulated signalling questions to facilitate judgment. The resulting RoB tool for animal studies contains 10 entries. These entries are related to selection bias, performance bias, detection bias, attrition bias, reporting bias and other biases. Half these items are in agreement with the items in the Cochrane RoB tool. Most of the variations between the two tools are due to differences in design between RCTs and animal studies. Shortcomings in, or unfamiliarity with, specific aspects of experimental design of animal studies compared to clinical studies also play a role. SYRCLE's RoB tool is an adapted version of the Cochrane RoB tool. Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies. This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the methodological quality of animal studies.
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Objectives A P-value <0.05 is one metric used to evaluate the results of a randomized controlled trial (RCT). We wondered how often statistically significant results in RCTs may be lost with small changes in the numbers of outcomes. Study Design and Setting A review of RCTs in high-impact medical journals that reported a statistically significant result for at least one dichotomous or time-to-event outcome in the abstract. In the group with the smallest number of events, we changed the status of patients without an event to an event until the P-value exceeded 0.05. We labeled this number the Fragility Index; smaller numbers indicated a more fragile result. Results The 399 eligible trials had a median sample size of 682 patients (range: 15–112,604) and a median of 112 events (range: 8–5,142); 53% reported a P-value <0.01. The median Fragility Index was 8 (range: 0–109); 25% had a Fragility Index of 3 or less. In 53% of trials, the Fragility Index was less than the number of patients lost to follow-up. Conclusion The statistically significant results of many RCTs hinge on small numbers of events. The Fragility Index complements the P-value and helps identify less robust results.
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In response to limitations in the understanding and use of published evidence, evidence-based medicine (EBM) began as a movement in the early 1990s. EBM's initial focus was on educating clinicians in the understanding and use of published literature to optimise clinical care, including the science of systematic reviews. EBM progressed to recognise limitations of evidence alone, and has increasingly stressed the need to combine critical appraisal of the evidence with patient's values and preferences through shared decision making. In another progress, EBM incorporated and further developed the science of producing trustworthy clinical practice guidelines pioneered by investigators in the 1980s. EBM's enduring contributions to clinical medicine include placing the practice of medicine on a solid scientific basis, the development of more sophisticated hierarchies of evidence, the recognition of the crucial role of patient values and preferences in clinical decision making, and the development of the methodology for generating trustworthy recommendations.
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Purpose – Progress in theory building in the field of collaborative networks in manufacturing is preponderantly seen in contributions from disciplines outside manufacturing science. Interdisciplinary research is one way of accelerating the development of appropriate theory for this emerging domain where industrial practice has moved beyond the state of the art of scientific knowledge for establishing workable, competitive solutions. The purpose of this paper is to examine to what extent interdisciplinary research has contributed to a better understanding of collaborative (manufacturing) networks. Design/methodology/approach – To find out more about provenances of on‐going studies, to identify clusters of contributions and to provide direction for future work of researchers in this domain, publications of the past 22 years have been evaluated. To retrieve these contributions, a structured literature review has been undertaken by applying keywords to selected databases and using a strictly defined stepwise procedure. In total, 202 publications of all kinds have been evaluated. Findings – From the analysis of the results, it appears that most interdisciplinary contributions to collaborative (manufacturing) networks rely on one original outside discipline for either developing solutions or advancing theoretical insight. Consequently, and after further analysis, it seems that researchers in collaborative networks hardly resort to multi‐disciplinary approaches, unless “natural”; further advances might arrive from stimulating these multi‐disciplinary avenues rather than sticking to more mono‐disciplinary, and less risky, takes on both applications and theoretical insight. A more detailed investigation of the value of contributions reveals that efforts to make interdisciplinary advances are either difficult or limited. Also, the findings indicate that researchers tend to follow a more “technical” approach to decision making by actors in networks rather than searching for a shift in paradigm. Originality/value – While setting out these directions for future research and guiding research, this first‐of‐its‐kind review introduces the collaboration model as a systematic approach to collaborative (manufacturing) networks. This model might serve as a reference model to integrate disciplines for addressing the characteristics of Collaborative Networks. Its use in the review led to the finding that typical traits of networks, such as changeability, supplementary assets and decentralisation of decision making, are under‐researched.
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Objective. —To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects.Design. —An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects.Data Sources. —Meta-analyses from the Cochrane Pregnancy and Childbirth Database.Main Outcome Measures. —The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding.Results. —Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P<.001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P=.01), with odds ratios being exaggerated by 17%.Conclusions. —This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.(JAMA. 1995;273:408-412)
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The aim of this paper is to explore the conditions under which generalisation from single case studies, in the sense of making inferences concerning a wider class of phenomena beyond a case, is reasonable. Two sets of conditions, in particular, provide the basis for our consideration of this issue. The first is an exploration of the impressive amount of empirical knowledge that is contained within the theories that are used to make observations, to classify phenomena, and to understand and interpret cases. The second is recognition of the role of a pattern of inference known as abduction, or inference to the best explanation, in drawing conclusions from case studies. It is argued that these two conditions, when applied to the procedures for conducting case studies, can be used to defend, as reasonable, the making of certain provisional generalisations from single cases. An epistemological procedure for testing and further justifying these generalisations, with a particular emphasis on dealing with the problem of confirmation bias, is then discussed and recommended.
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Schumpeter first reviews the basic economic concepts that describe the recurring economic processes of a commercially organized state in which private property, division of labor, and free competition prevail. These constitute what Schumpeter calls "the circular flow of economic life," such as consumption, factors and means of production, labor, value, prices, cost, exchange, money as a circulating medium, and exchange value of money. The principal focus of the book is advancing the idea that change (economic development) is the key to explaining the features of a modern economy. Schumpeter emphasizes that his work deals with economic dynamics or economic development, not with theories of equilibrium or "circular flow" of a static economy, which have formed the basis of traditional economics. Interest, profit, productive interest, and business fluctuations, capital, credit, and entrepreneurs can better be explained by reference to processes of development. A static economy would know no productive interest, which has its source in the profits that arise from the process of development (successful execution of new combinations). The principal changes in a dynamic economy are due to technical innovations in the production process. Schumpeter elaborates on the role of credit in economic development; credit expansion affects the distribution of income and capital formation. Bank credit detaches productive resources from their place in circular flow to new productive combinations and innovations. Capitalism inherently depends upon economic progress, development, innovation, and expansive activity, which would be suppressed by inflexible monetary policy. The essence of development consists in the introduction of innovations into the system of production. This period of incorporation or adsorption is a period of readjustment, which is the essence of depression. Both profits of booms and losses from depression are part of the process of development. There is a distinction between the processes of creating a new productive apparatus and the process of merely operating it once it is created. Development is effected by the entrepreneur, who guides the diversion of the factors of production into new combinations for better use; by recasting the productive process, including the introduction of new machinery, and producing products at less expense, the entrepreneur creates a surplus, which he claims as profit. The entrepreneur requires capital, which is found in the money market, and for which the entrepreneur pays interest. The entrepreneur creates a model for others to follow, and the appearance of numerous new entrepreneurs causes depressions as the system struggles to achieve a new equilibrium. The entrepreneurial profit then vanishes in the vortex of competition; the stage is set for new combinations. Risk is not part of the entrepreneurial function; risk falls on the provider of capital. (TNM)
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Titles constitute the most concise statement of a document's content, and are heavily used by information retrieval systems. Consequently, the great importance of titles being highly informative is indisputable. The most common measure of title ‘informativity’ has been the number of ‘substantive’ words it includes. Previous studies found significant differences between journals of different subject fields, in the sciences and the social sciences, regarding the number of substantive words in article titles. However, unlike the sciences and the social sciences, very little research has been done onhumanities journals. Examining title informativity in a group of eighteen leading English-language journals, covering various humanities disciplines, from 1940 to 1990, the present study searched for possible differences between the humanities journal and the scientific and social sciences ones, concerning patterns of title informativity. Generally, considerable differences were found in the number of substantive words in article titles between the various humanities journals checked. On the other hand, a comparison of thegroup-average means and medians of the humanities journals to group figures of journals from the sciences and the social sciences indicates significant differences for almost all decade years studied. However, titles of papers in humanities journals did follow the general trend of increase in informativity, although in a slower pace. Possible explanations of these differences are discussed and areas for further study are suggested.
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GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing systematic review authors and guideline developers to arrive at an outcome-specific rating of confidence. Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain. An overall rating of confidence in estimates of effect is only relevant in settings when recommendations are being made. In general, it is based on the critical outcome that provides the lowest confidence.
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Although it is a very small part of the research paper, the title plays an important role as the first point of contact between writer and potential reader and may decide whether or not the paper is read. Research paper titles in the widely differing fields of science, literature and linguistics are studied in detail with a view to showing what researchers from each discipline implicitly feel are important features in the succinct knowledge transmission required in title design. Three basic types of titles in the three disciplines are analyzed: full sentence, compound and a remaining group made up largely of noun phrases with or without postmodification. Very clear-cut differences in frequency and form were found across the three disciplines reflecting fundamental differences in pragmatic intention inherent in the disciplines concerned. Analysis focusses on the role of titles in informing the reader as to what the paper is about and also in attracting him/her to read the paper. Discussion of how these functions are met rests on techniques involved in both information packaging and advertising.
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To create a practical and validated item bank for evaluating the risk of bias and precision of observational studies of interventions or exposures included in systematic evidence reviews. The item bank, developed at RTI International, was created based on 1,492 questions included in earlier instruments, organized by the quality domains identified by Deeks et al. Items were eliminated and refined through face validity, cognitive, content validity, and interrater reliability testing. The resulting item bank consisting of 29 questions for evaluating the risk of bias and precision of observational studies of interventions or exposures (1) captures all of the domains critical for evaluating this type of research, (2) is comprehensive and can be easily lifted "off the shelf" by different researchers, (3) can be adapted to different topic areas and study types (e.g., cohort, case-control, cross-sectional, and case series studies), and (4) provides sufficient instruction to apply the tool to varied topics. One bank of items, with specific instructions for focusing abstractor evaluations, can be created to judge the risk of bias and precision of the variety of observational studies that may be used in systematic and comparative effectiveness reviews.
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GRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality of evidence (i.e., confidence in estimates of effect) is required if clinical action would differ if the upper versus the lower boundary of the CI represented the truth. An exception to this rule occurs when an effect is large, and consideration of CIs alone suggests a robust effect, but the total sample size is not large and the number of events is small. Under these circumstances, one should consider rating down for imprecision. To inform this decision, one can calculate the number of patients required for an adequately powered individual trial (termed the "optimal information size" [OIS]). For continuous variables, we suggest a similar process, initially considering the upper and lower limits of the CI, and subsequently calculating an OIS. Systematic reviews require a somewhat different approach. If the 95% CI excludes a relative risk (RR) of 1.0, and the total number of events or patients exceeds the OIS criterion, precision is adequate. If the 95% CI includes appreciable benefit or harm (we suggest an RR of under 0.75 or over 1.25 as a rough guide) rating down for imprecision may be appropriate even if OIS criteria are met.
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This article deals with inconsistency of relative (rather than absolute) treatment effects in binary/dichotomous outcomes. A body of evidence is not rated up in quality if studies yield consistent results, but may be rated down in quality if inconsistent. Criteria for evaluating consistency include similarity of point estimates, extent of overlap of confidence intervals, and statistical criteria including tests of heterogeneity and I(2). To explore heterogeneity, systematic review authors should generate and test a small number of a priori hypotheses related to patients, interventions, outcomes, and methodology. When inconsistency is large and unexplained, rating down quality for inconsistency is appropriate, particularly if some studies suggest substantial benefit, and others no effect or harm (rather than only large vs. small effects). Apparent subgroup effects may be spurious. Credibility is increased if subgroup effects are based on a small number of a priori hypotheses with a specified direction; subgroup comparisons come from within rather than between studies; tests of interaction generate low P-values; and have a biological rationale.
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In the GRADE approach, randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down if a body of evidence is associated with a high risk of publication bias. Even when individual studies included in best-evidence summaries have a low risk of bias, publication bias can result in substantial overestimates of effect. Authors should suspect publication bias when available evidence comes from a number of small studies, most of which have been commercially funded. A number of approaches based on examination of the pattern of data are available to help assess publication bias. The most popular of these is the funnel plot; all, however, have substantial limitations. Publication bias is likely frequent, and caution in the face of early results, particularly with small sample size and number of events, is warranted.
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The most common reason for rating up the quality of evidence is a large effect. GRADE suggests considering rating up quality of evidence one level when methodologically rigorous observational studies show at least a two-fold reduction or increase in risk, and rating up two levels for at least a five-fold reduction or increase in risk. Systematic review authors and guideline developers may also consider rating up quality of evidence when a dose-response gradient is present, and when all plausible confounders or biases would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. Other considerations include the rapidity of the response, the underlying trajectory of the condition, and indirect evidence.
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In the GRADE approach, randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias. Well-established limitations of randomized trials include failure to conceal allocation, failure to blind, loss to follow-up, and failure to appropriately consider the intention-to-treat principle. More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results. Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance. Risk of bias may vary across outcomes (e.g., loss to follow-up may be far less for all-cause mortality than for quality of life), a consideration that many systematic reviews ignore. In deciding whether to rate down for risk of bias--whether for randomized trials or observational studies--authors should not take an approach that averages across studies. Rather, for any individual outcome, when there are some studies with a high risk, and some with a low risk of bias, they should consider including only the studies with a lower risk of bias.
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This article introduces the approach of GRADE to rating quality of evidence. GRADE specifies four categories-high, moderate, low, and very low-that are applied to a body of evidence, not to individual studies. In the context of a systematic review, quality reflects our confidence that the estimates of the effect are correct. In the context of recommendations, quality reflects our confidence that the effect estimates are adequate to support a particular recommendation. Randomized trials begin as high-quality evidence, observational studies as low quality. "Quality" as used in GRADE means more than risk of bias and so may also be compromised by imprecision, inconsistency, indirectness of study results, and publication bias. In addition, several factors can increase our confidence in an estimate of effect. GRADE provides a systematic approach for considering and reporting each of these factors. GRADE separates the process of assessing quality of evidence from the process of making recommendations. Judgments about the strength of a recommendation depend on more than just the quality of evidence.