Development Of Standardized Methodology Research Articles

Should Subanesthetic Ketamine be Considered When Managing Opioid Refractory Cancer Pain?

In the cancer pain setting, ketamine has been typically employed as a co-analgesic for opioid refractory and neuropathic pain. One controversial topic is whether subanesthetic ketamine be considered when managing opioid refractory cancer pain. In this “Controversies in Palliative Care” article, three clinicians independently answer this question. Specifically, each clinician provides a synopsis of the key studies that inform their thought processes, share practical advice on their clinical approach, and highlight the opportunities for future research. Three independent clinicians reported a divergence of opinion regarding the usefulness of subanesthetic ketamine for managing opioid refractory cancer pain. All investigators acknowledged the lack of high-quality trials. All agreed on the need for adequately powered trials, the development of standardized methodology, and the exploration of any patient sub-populations that may benefit from ketamine for cancer related pain.

Digital Twin: Reference Model, Realizations, and Recommendations

ABSTRACTOrganizations continuously develop Digital Twins across a wide number of applications and industries. While this represents a testimony to the benefits and opportunities Digital Twins provide (AIAA 2022), their development, maintenance and evolution still face major challenges (Bordeleau et al. 2020). Most past and current efforts focusing on the development of Digital Twins have relied on ad‐hoc approaches, where most of the efforts start with building models without properly framing the problem (Martin 2019, Lu et al. 2020). More importantly it has led to the development of models that provide a solution to the wrong problem and consequently fail to address the core questions and needs of the stakeholders (Martin 2019)]. The development and implementation of Digital Twins also lack standardization (Shao 2021), instead relying on bespoke methods and technologies (Niederer et al. 2021), which in turns leads to a lack of consistency in their description and implementation, as well as limited interoperability across applications, tools and disciplines (Niederer et al. 2021, Piroumian 2021). The development of Digital Twins has been plagued by a lack of scalable approaches, leading to implementations that are highly specialized and require considerable resources in terms of subject matter expertise (Niederer et al. 2021).The development of standardized methodologies has been identified as a means to unleash the full potential of Digital Twins (Shao 2021, Piroumian 2021) and increase their adoption across a wider range of disciplines and applications (Niederer et al. 2021). To that end, this paper presents a domain agnostic and descriptive reference model, which builds on recognized industry practices and guidelines, to support the planning, description, and analysis of Digital Twins. It also introduces real‐world examples of aerospace Digital Twin use cases and discusses how the generic reference model supports the various use case applications. Finally, this paper briefly discusses recommendations and next steps on how to realize value from Digital Twins more broadly.

Adherence to World Glaucoma Association Guidelines for Surgical Trials in the Era of Microinvasive Glaucoma Surgeries

To determine how well microinvasive glaucoma surgical (MIGS) trials conform to the World Glaucoma Association (WGA) guidelines. Lack of well-designed MIGS studies hinders meaningful evaluation of these technologies. Cross-sectional literature survey. Using a predefined search strategy, the following databases were searched for comparative trials involving MIGS in the English peer-reviewed literature from January 1, 2000, through June 21, 2018: Medline, EMBASE, BIOSIS, Cochrane, and Web of Science. From the WGA guidelines, 53 outcomes were selected for evaluation: methodology (n= 31), definition of success (n= 7), ethics (n= 10), postoperative complications (n= 1), economic evaluation (n= 1), and statistical reporting (n= 3). Each article was assessed by 2 reviewers; differences were resolved by consensus. Twenty-five eligible publications were identified: 10 randomized controlled trials (RCTs) and 15 nonrandomized comparative trials (non-RCTs). The mean follow-up was 19.9±11.6 months (range, 6-48 months). The mean number of outcomes adhering to the WGA guidelines of the 53 evaluated was 24.2±6.1 (45.6% compliance): 28.0±6.2 (52.8%) and 21.6±4.7 (40.8%) for RCTs and non-RCTs, respectively (P= 0.01). Mean percent compliance for each subsection were: methodology, 48.8%; definition of success, 21.1%; ethics, 55.6%; postoperative complications, 88%; economic evaluation, 0%; and statistical reporting, 37.3%. In 16 studies (64%), at least 1 author reported an association with the industry. Thirty-two percent of studies reported an author being a shareholder. Twenty-four percent of studies had an industry employee author. The primary intraocular pressure (IOP) end point was defined as both an upper limit and percentage reduction in only 4 studies (16%; 1 RCT, 3 non-RCTs). An IOP-based survival curve was provided in 7 studies (28%; none of the RCTs). Two studies (8%) included an IOP scatterplot. Twelve studies (48%) reported 95% confidence intervals. Only 4 studies (16%) used the mean of 3 diurnal IOP readings as the baseline IOP. Published comparative MIGS trials show low adherence (45.6%) to the WGA guidelines. Development of standardized methodology and outcomes could enhance interpretation and transparency of study results and facilitate comparisons between trials. Authors and journals should be encouraged to follow the WGA guidelines.

The diagnostic accuracy of circulating tumor DNA for the detection of EGFR-T790M mutation in NSCLC: a systematic review and meta-analysis

This pooled analysis aims at evaluating the diagnostic accuracy of circulating tumor (ct) DNA for the detection of EGFR-T790M mutation in NSCLC patients who progressed after EGFR-TKIs. Data from all published studies, reporting both sensitivity and specificity of plasma-based EGFR-T790M mutation testing by ctDNA were collected by searching in PubMed, Cochrane Library, American Society of Clinical Oncology, European Society of Medical Oncology and World Conference of Lung Cancer meeting proceedings. A total of twenty-one studies, with 1639 patients, were eligible. The pooled sensitivity of ctDNA analysis was 0.67 (95% CI: 0.64–0.70) and the pooled specificity was 0.80 (95% CI: 0.77–0.83). The pooled positive predictive value (PPV) was 0.85 (95% CI: 0.82–0.87) and the pooled negative predictive value (NPV) was 0.60 (95% CI: 0.56–0.63). The positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 2.67 (95% CI: 1.86–3.82) and 0.46 (95% CI: 0.38–0.54), respectively. The pooled diagnostic odds ratio (DOR) was 7.27 (4.39–12.05) and the area under the curve (AUC) of the summary receiver operating characteristics (sROC) curve was 0.77. The ctDNA analysis represents a promising, non-invasive approach to detect and monitor the T790M mutation status in NSCLC patients. Development of standardized methodologies and clinical validation are recommended.

A Literature Review of Downwind Drift from Airblast Sprayers: Development of Standard Methodologies and a Drift Database

<abstract> Empirical data available from studies of downwind drift of agrochemicals associated with horticultural broadcast air-assisted spraying within the U.S. are limited compared to the data available for aerial or ground applications to arable crops. There is interest in evaluating the extent to which drift studies conducted in the European Union and elsewhere are applicable to U.S. agricultural practices due to the lack of data currently available. To expand the database available for drift assessment, a review of the literature was undertaken. The original intent of the work presented here was to conduct a meta-analysis of the data collected in order to assess the feasibility of developing standard curves for applications made under a standard set of conditions. It is seldom possible to pool data from different geographic regions for row crop applications due to large differences in the scale of agriculture, leading to significant disparities in agronomic practices. These differences make it impossible to use studies generated in one geographic region to make inferences elsewhere. It is possible, however, that there is enough geographic similarity in the agronomic practices used in bush and tree crops to allow the pooling of data. Although there was nothing about the scale of agriculture that prevented direct comparison, a meta-analysis of the data was not conducted due to the variations in crop type, application techniques, and sampling methods in the collected studies. In response, this article discusses the global issues in methodology and reporting that precluded the meta-analysis of data and describes which parameters require standardization to enable comparative assessment. The product of this effort is the collation of large quantities of data into an open-source database. The individual datasets could be used to make inferences regarding drift potential of specific analogous applications, or the data may be used by researchers for the design and validation of models.

Prevalence of Nonsuicidal Self‐Injury in Nonclinical Samples: Systematic Review, Meta‐Analysis and Meta‐Regression

Published prevalence estimates of nonsuicidal self-injury (NSSI) among nonclinical samples are highly heterogeneous, raising concerns about their reliability and hindering attempts to explore the alleged increase in NSSI over time. Accordingly, the objectives of this study were to investigate the influence of methodological factors on heterogeneity in NSSI prevalence estimates, explore changes over time, and estimate overall international NSSI prevalence. Results showed that methodological factors contributed over half (51.6%) of the heterogeneity in prevalence estimates, and, after adjusting for these factors, NSSI prevalence did not increase over time. Overall, pooled NSSI prevalence was 17.2% among adolescents, 13.4% among young adults, and 5.5% among adults. Clearly, development of standardized methodology in NSSI research is crucial if accurate estimates are desired.

Development of a Non-Destructive Evaluation Practice of Installed Weatherproofing Sealant Joints Using a Rolling Device—An Introduction to ASTM C 1736

Abstract This paper provides an overview of the development of standardized methodology to evaluate joint seal continuity, encompassed in the newly published ASTM C 1736-11, “Standard Practice for Non-Destructive Evaluation of Adhesion of Installed Weatherproofing Sealant Joints Using a Rolling Device.” This standard practice was created under the jurisdiction of ASTM Committee C 24 on Building Seals and Sealants and is the direct responsibility of Subcommittee 30 on Adhesion; it was approved July 1, 2011. Fundamental details contributing to the successful usage of this practice are examined by answering the following questions: Where exactly do the stresses produced by this procedure have an effect upon the sealant-to-substrate bond-line? How does joint geometry impact this bond-line stress? What level of stress on a bond-line provides usable information without damaging the seal?

The eurociss project: development of standardized methodology for monitoring coronary heart disease in Europe

The eurociss project: development of standardized methodology for monitoring coronary heart disease in Europe

A EUROPEAN MEETING HELD TO DISCUSS DERMAL EXPOSURE MONITORING AND RELATED ISSUES, BRUSSELS, BELGIUM, 21–23 JUNE 1994

Recognizing the significance of dermal exposure, the European Commission funded and convened a consultative meeting on dermal exposure and related issues, with the objectives of identifying gaps in knowledge, discussing future research requirements and exploring the possibility of establishing a research network for the purpose of stimulating collaborative European R&D projects. The meeting began with a series of keynote review lectures covering a range of issues associated with dermal exposure. Participants from the United States outlined the prevailing situation and likely future developments in dermal exposure assessment in the United States, and representatives of participating European states then presented a brief summary of regulatory position regarding dermal exposure in their respective countries. The prevailing position in skin and surface contamination monitoring was discussed and gaps in knowledge identified; areas of work which would result in the development of standardized methodologies were debated. The meeting resulted in the formation of five syndicate groups, these include: (i) occupational exposure assessment-risk assessment; (ii) biological monitoring; (iii) skin and surface contamination; (iv) in vitro models (skin penetration); and (v) source apportionment (dermal vs air exposure). Each syndicate group discussed and identified the R&D requirements in its area of interest and reported its findings to the meeting There was a consensus that a need exists for the establishment of a European network on dermal exposure to co-ordinate efforts in this field. Preparatory work for the establishment of the network is currently underway

Analyse critique de méthodes d'évaluation économique des actions de santé : l'exemple du dépistage prénatal de la trisomie 21

Valérie Séror: A critical analysis of methods of economie evaluation of public health intervention: the example of prenatal screening for Down's syndrome. Methodologies stemed from public economies field are more and more frequently used in order to assess health care public policies. While these evaluation studies are working towards the development of standardized methodologies, theorical and empirical difficulties still remain. This paper considers economie concepts underlying the measure of costs and health consequences as effectiveness and benefit. After a brief account of the different tools at the economiste disposal, emphasis will be put on identification and measurement of allocated resources in the way of comparability of economie evaluations. A special attention will be given to consequences identification and assessment, according to cost effectiveness and cost-benefit analysis principles. The latter will be analyzed according to social rentability perspectives and willingness-to-pay as an integrative tool of individual preferences. Contributions resulting of the use of economie evaluation methodologies in health care, as well as theorical and empirical difficulties will be discussed in the special case of Down's syndrome prevention, a particularly illustrative example.