scholarly journals Using Systematic Reviews and Meta-Analyses to Support Regulatory Decision Making for Neurotoxicants: Lessons Learned from a Case Study of PCBs

2010 ◽  
Vol 118 (6) ◽  
pp. 727-734 ◽  
Author(s):  
Michael Goodman ◽  
Katherine Squibb ◽  
Eric Youngstrom ◽  
Laura Gutermuth Anthony ◽  
Lauren Kenworthy ◽  
...  

2011 ◽  
Vol 16 (7) ◽  
pp. 3207-3220
Author(s):  
Michael Goodman ◽  
Katherine Squibb ◽  
Eric Youngstrom ◽  
Laura Gutermuth Anthony ◽  
Lauren Kenworthy ◽  
...  

We examined prospective cohort studies evaluating the relation between prenatal and neonatal exposure to polychlorinated biphenyls (PCBs) and neurodevelopment in children to assess the feasibility of conducting a meta-analysis to support decision making. We described studies in terms of exposure and end point categorization, statistical analysis, and reporting of results. We used this evaluation to assess the feasibility of grouping studies into reasonably uniform categories. The most consistently used tests included Brazelton's Neonatal Behavioral Assessment Scale, the neurologic optimality score in the neonatal period, the Bayley Scales of Infant Development at 5-8months of age, and the McCarthy Scales of Children's Abilities in 5-year-olds. Despite administering the same tests at similar ages, the studies were too dissimilar to allow a meaningful quantitative examination of outcomes across cohorts. These analyses indicate that our ability to conduct weight-of-evidence assessments of the epidemiologic literature on neurotoxicants may be limited, even in the presence of multiple studies, if the available study methods, data analysis, and reporting lack comparability.



2020 ◽  
Vol 1 (1) ◽  
pp. 24-40
Author(s):  
Zoe Bastone

Outreach is a necessary component of an academic library’s operations and often requires extensive time for the planning, approval, execution, and assessment depending on the personnel involved and the scope of the event. Recent literature has started to examine how academic libraries are planning outreach to align strategically with the goals of their larger institutions, but not how they balance these efforts when new opportunities arise throughout the academic year. This article will provide a brief analysis of the literature which addresses issues that academic librarians who plan outreach face. The second half of this article will provide a case study of how the author planned, created, and implemented an outreach plan at her academic branch library. This case study will detail the process of how she used an outreach plan to establish outreach that was efficient and impactful with limited staffing, while also aligning strategically with the goals of her library and the larger institution. In addition, this case study will detail how she used this outreach plan throughout the 2019-2020 academic year to guide decision making when new outreach opportunities would arise. This article will conclude with lessons learned from this process.



Author(s):  
Jiayin Hang ◽  
Heidi Hohensohn ◽  
Klaus Mayr ◽  
Thomas Wieland

This chapter intends to show how companies can benefit from open source software and its development culture and how the open source communities could, in turn, be stimulated and accelerated. One of the first major steps for businesses that plan to act in this context is to accept that open source projects have their own communication culture. After explaining this fact, we illustrate its relevance on the basis of a case study in which an open source framework was used to build a commercial product. The decision-making process and the lessons learned from it point out some guidelines, particularly for companies that offer projects rather than products. As there are, however, more parties involved than just the developers when OSS is discussed as a business opportunity, we also classify the different players in the software business such as distributors, system integrators, and software/hardware vendors. Findings on roles and their motivations and restraints, partially based on a survey carried out within our research project, point up this categorization. The authors hope that this overview of the benefits and pitfalls will encourage more companies to make use of and invest in the open source way to develop and deploy software.



Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 435-441 ◽  
Author(s):  
Victor M Lu ◽  
Christopher S Graffeo ◽  
Avital Perry ◽  
Michael J Link ◽  
Fredric B Meyer ◽  
...  

Abstract Systematic reviews and meta-analyses in the neurosurgical literature have surged in popularity over the last decade. It is our concern that, without a renewed effort to critically interpret and appraise these studies as high or low quality, we run the risk of the quality and value of evidence-based medicine in neurosurgery being misinterpreted. Correspondingly, we have outlined 4 major domains to target in interpreting neurosurgical systematic reviews and meta-analyses based on the lessons learned by a collaboration of clinicians and academics summarized as 4 pearls. The domains of (1) heterogeneity, (2) modeling, (3) certainty, and (4) bias in neurosurgical systematic reviews and meta-analyses were identified as aspects in which the authors’ approaches have changed over time to improve robustness and transparency. Examples of how and why these pearls were adapted were provided in areas of cranial neuralgia, spine, pediatric, and neuro-oncology to demonstrate how neurosurgical readers and writers may improve their interpretation of these domains. The incorporation of these pearls into practice will empower neurosurgical academics to effectively interpret systematic reviews and meta-analyses, enhancing the quality of our evidence-based medicine literature while maintaining a critical focus on the needs of the individual patients in neurosurgery.



2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Anna Lene Seidler ◽  
Kylie Hunter ◽  
Saskia Cheyne ◽  
Jesse Berlin ◽  
Davina Ghersi ◽  
...  

Abstract Focus of Presentation In a prospective meta-analysis (PMA), studies are included before their results are known. This can reduce risk of publication bias and selective outcome reporting, and enables researchers to harmonise their research efforts. Despite rising numbers, there is little guidance on how to conduct PMA. We, the Cochrane PMA Methods Group, developed step-by-step guidance based on a scoping review, and expert opinions and experiences. Each step is illustrated with a recent case study. Findings We describe seven steps for conducting PMA. After developing a protocol (Steps 1), a systematic search for eligible planned/ongoing studies should be conducted, including a search of registries, medical databases and contacting stakeholders (Step 2-3). These studies are then invited to form a collaboration (Step 4), ideally including a steering and data analysis committee. Next, important study features such as common core outcomes and confounders are agreed upon (Step 5). This reduces heterogeneity and increases the number of available outcomes for meta-analysis. Certainty of evidence is assessed by adapting tools such as GRADE (Step 6). Results should be reported using adapted versions of reporting tools such as PRISMA (Step 7). Conclusions/Implications PMA reduce many problems of traditional retrospective systematic reviews and meta-analysis. Updated guidance and recent technical advances will help increase their numbers further. Key messages PMA are ‘next generation systematic reviews’ that allow for greatly improved use of data, whilst reducing bias and research waste. This step-by-step guidance will enable more researchers to conduct successful PMA.



2016 ◽  
Vol 17 (10) ◽  
pp. 2699-2717 ◽  
Author(s):  
Aude Marzuoli ◽  
Emmanuel Boidot ◽  
Pablo Colomar ◽  
Mathieu Guerpillon ◽  
Eric Feron ◽  
...  


2014 ◽  
Vol 513-517 ◽  
pp. 2672-2675
Author(s):  
Yuan Cheng Tsai ◽  
Yi Lun Chi

The paper formulated a proposed methodology to manage diminishing manufacturing sources and material shortage (DMS) with conclusions and recommendations on the subject of component obsolescence management in a military electronic support environment. By assessing applicable literature as well as feedback and lessons learned from relevant support projects, a strategy for the management of component obsolescence is proposed. The aim of the research is to explore the problem of managing DMS strategies by the method of project management and describes the risk of running distinct strategies to solve problems of DMS by fuzzy theory and possibility theory. Based on the results, this paper can be applied to support businesses quickly to determine the Strategies Combination, Resource Allocation and Inventory by using the model and genetic algorithm. A case study of an aerospace industry is used to illustrate the concept developed, which would be meaningful to reduce applicable obsolescence risks and thereby reducing related inventory and manpower costs.



2013 ◽  
Vol 23 (2) ◽  
Author(s):  
Inger Natvig Norderhaug

<p>En god helsetjeneste forutsetter god kunnskap som grunnlag for de valg som gjøres. Systematiske oversikter som sammenfatter tilgjengelig forskningsbasert kunnskap er en viktig del av beslutningsgrunnlaget, enten det er snakk om effektene av tiltak, hvorfor sykdom oppstår, diagnostikk, prognose, eller hvordan sykdom oppleves for dem som rammes.</p><p>Systematiske oversikter er blitt en vel anerkjent kilde for kunnskap om effekt av helsetiltak, med bred internasjonal enighet om metodene som bør benyttes ved utvikling av slike oversikter. Når det gjelder systematiske oversikter for å sammenfatte resultater fra epidemiologisk forskning på årsaksspørsmål er erfaringene langt mindre.</p><p>Samtidig som systematiske oversikter over epidemiologiske studier i større grad bør inngå i beslutningsprosesser, er det et betydelig behov for metodeutvikling. Dette gjelder særlig kriterier for vurdering av kvalitet på epidemiologiske studier, metoder for sammenfatning av resultater i metaanalyser og kriterier for å gradere tillit til de endelige estimatene. Publikasjonsskjevheter er en utfordring for all forskning, og det er behov for initiativ for å sikre bedre rapportering av funn fra epidemiologiske studier, blant annet publisering av studieprotokoller.</p><p>Norderhaug IN. <strong>Systematic reviews of epidemiological research</strong>. <em>Nor J Epidemiol</em> 2013; <strong>23</strong> (2): 125-130.</p><p><strong>ENGLISH SUMMARY</strong></p><p>In health care, good knowledge is key to sound decision making. Good management of knowledge can be achieved through systematic reviews for various questions including the effects of health care interventions, causes of disease, how to best diagnose diseases, prognosis, as well as people’s experiences from living with disease.</p><p>Systematic reviews are well recognized and valued resources to inform decisions regarding health care interventions. Furthermore there is broad international consensus on methods for conducting systematic reviews on the effects of health care interventions. Although the need for systematic reviews is recognized also for epidemiological questions, such as the causes of disease, the level of experience in this area is far less than for systematic reviews on the effects of interventions.</p><p>Thus, alongside the need for better integration of systematic reviews in epidemiology into health care decision making processes, methodological developments are needed, particularly on how to assess the quality of epidemiological studies, methods for combining the results in meta-analyses, and criteria for grading our confidence in the final estimates.</p><p>Publication bias is a problem in all research, and initiatives are needed to improve planning and reporting of epidemiological studies, such as publication of study protocols.</p>



2020 ◽  
Vol 32 (9) ◽  
pp. 639-642
Author(s):  
Ya-Ting Yang ◽  
Yi-Hsin Elsa Hsu ◽  
Kung-Pei Tang ◽  
Christine Wang ◽  
Stephen Timmon ◽  
...  

Abstract Quality problem or issue In the context of medical tourism, cultural differences and language barriers are unneglectable factors, which compromise the shared decision-making between doctor and patients. Initial assessment This study constructs a cultural sensitivity cultivation (CSC) model that could be used to train medical professionals in the sector of medical tourism. Choice of solution Since 2016, there have been explorations in new strategies to offer better services. A critical step added is to include clients’ perspectives in the re-examining process as a way to cultivate cultural sensitivity among the service providers. This practice expands to the sector of medical tourism. In our case study, we are able to conclude a new model that could yield quality international healthcare services. Implementation The steps of our CSC model include (i) ‘Promote Awareness’ for shifting mindset, (ii) ‘Share Scenarios’ for developing empathy and compassion, (iii) ‘Review Process’ for collecting detail feedback, (iv) ‘Identify Gaps’ for targeting areas for improvement and (v) ‘Improve Systems,’ for changing standard operation procedures (SOPs) based on the strategies through Assmann’s theory with a cultural–anthropological approach. Evaluation After Kuang Tien General Hospital (KTGH) implemented the new model for 1 year, the number of international patients has increased by 64%. More research could be done in the future to cover all the important aspects of providing international medical services and could apply the CSC model to different healthcare settings. Lessons learned To optimize the shared decision-making between the doctor and medical traveler patients, healthcare providers should not only overcome language and cultural barriers but also should avoid unnecessary gestures in terms of status respect. Inviting patients to be co-investigator for quality improvement is a viable solution.



2021 ◽  
Vol 12 ◽  
Author(s):  
Thomas Platz

Quality of healthcare can be improved when the best external evidence available is integrated in clinical decision-making in a systematic explicit manner. With the rapid expansion of clinical evidence, the opportunities for evidence-based high-quality healthcare increase. Paradoxically, the likelihood of any one person to get a complete and balanced picture of the evidence available decreases. This is especially true for rehabilitation interventions that are complex in nature and where clinical research is rather diverse. Given the complex nature of the evidence, there is a substantial risk of misinterpreting the complex information both at the level of individual sources (e.g., reports of clinical trials) and for aggregated data syntheses (e.g., systematic reviews and meta-analyses). These risks are inherent in these sources themselves and are in addition related to the methodological expertise necessary to make valid use of the evidence for clinical decision-making. Taken together, there is a great demand for systematic structured guidance from evidence to clinical decision. This methodology paper describes a structured process for the development and report of evidence-based clinical practice recommendations that uses systematic reviews and meta-analyses as evidence source. It provides a comprehensive framework with specific requirements for the development group, the formulation of the healthcare question addressed, the systematic search for the evidence, its critical appraisal, the extraction and the outcome-centered presentation of the evidence, the rating of its quality, strengths and weaknesses, any further considerations relevant for decision-making, and an explicit recommendation statement along with its justification, implementation, and resource aspects. The suggested methodology uses international standards in evidence synthesis, critical appraisal of systematic reviews, rating the quality of evidence, characteristics of recommendations, and guideline development as developed by Cochrane, GRADE (Grading of Recommendations Assessment, Development and Evaluation), AMSTAR (A MeaSurement Tool to Assess systematic Reviews), and AGREE (Appraisal of Guidelines for REsearch &amp; Evaluation). An added distinctive feature of the methodology is to focus on the most up-to-date, most valid evidence and hence to support the development of valid practice recommendations in an efficient way. Practice recommendations generated by such a valid methodology would be generally applicable and promote evidence-based clinical practice globally.



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