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Author(s):  
Dawid Storman ◽  
Magdalena Koperny ◽  
Joanna Zając ◽  
Maciej Polak ◽  
Paulina Weglarz ◽  
...  

Systematic reviews/meta-analyses (SR/MAs) are considered a reliable source of information in healthcare. We aimed to explore the association of several characteristics of SR/MAs addressing nutrition in cancer prevention and their quality/risk of bias (using assessments from AMSTAR-2 and ROBIS tools). The analysis included 101 SR/MAs identified in a systematic survey. Associations of each specified characteristic (e.g., information about the protocol, publication year, reported use of GRADE, or other methods for assessing overall certainty of evidence) with the number of AMSTAR-2 not met (‘No’ responses) and the number of ROBIS items met (‘Probably Yes’ or “Yes’ responses) were examined. Poisson regression was used to identify predictors of the number of ‘No’ answers (indicating lower quality) for all AMSTAR-2 items and the number of ‘Yes’ or ‘Probably Yes’ answers (indicating higher quality/lower concern for bias) for all ROBIS items. Logistic regression was used to identify variables associated with at least one domain assessed as ‘low concern for bias’ in the ROBIS tool. In multivariable analysis, SR/MAs not reporting use of any quality/risk of bias assessment instrument for primary studies were associated with a higher number of ‘No’ answers for all AMSTAR-2 items (incidence rate ratio (IRR) 1.26, 95% confidence interval (CI) 1.09–1.45), and a lower number of ‘Yes’ or ‘Probably Yes’ answers for all ROBIS items (IRR 0.76, 95% CI 0.66–0.87). Providing information about the protocol and search for unpublished studies was associated with a lower number of ‘No’ answers (IRR 0.73, 95% CI 0.56–0.97 and IRR 0.75, 95% CI 0.59–0.95, respectively) and a higher number of ‘Yes’ or ‘Probably Yes’ answers (IRR 1.43, 95% CI 1.17–1.74 and IRR 1.28, 95% CI 1.07–1.52, respectively). Not using at least one quality/risk of bias assessment tool for primary studies within an SR/MA was associated with lower odds that a study would be assessed as ‘low concern for bias’ in at least one ROBIS domain (odds ratio 0.061, 95% CI 0.007–0.527). Adherence to methodological standards in the development of SR/MAs was associated with a higher overall quality of SR/MAs addressing nutrition for cancer prevention.


2022 ◽  
Vol 2152 (1) ◽  
pp. 012018
Author(s):  
Qi Feng ◽  
Hongtu Song

Abstract Based on the analysis of operation methods of rail welding and postweld heat treatment in the track change overhaul of existing railway lines at home and abroad, this paper puts forward the existing problems in the operation methods of off-line welding and on-line welding in China, and puts forward the solutions to the existing problems. When this operation mode is used for on-line welding, it can reduce the quality risk in the heat treatment process of low-temperature locking joint; in case of broken track and urgent repair of broken track, this method can eliminate secondary shunting and facilitate the recovery of the line as soon as possible.


Yakhak Hoeji ◽  
2021 ◽  
Vol 65 (6) ◽  
pp. 432-440
Author(s):  
Sangjae Lee ◽  
Jaeho Jung ◽  
Minyeong Shin ◽  
Intaek Jang ◽  
Taekyu Kim

Author(s):  
Holger Kranenburg ◽  
Birte Scharf ◽  
Patrick Wolf ◽  
Robert Lindner

No-Touch Transfer (NTT) of pre-sterilised ready-to-use (RTU) containers is an alternative methodology that follows Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. NTT de-bagging ejects contents from secondary bag packaging without direct contact with contents or exposure to an environment that is a lower grade than the zone being entered. The pre-sterilised containers and sterile barriers offer assured sterility at manufacture and are qualified to remain sterile through the supply chain and the stepwise NTT de-bagging process. This eliminates the requirement for in-process material disinfection steps for transfer into Grade A environments. The present article focuses on design qualification of pre-sterilised RTU container packaging, including definition of sterile barriers together with bioburden study data through the supply chain and simulated NTT. It completes a series of EJPPS articles to support peer-reviewed references on NTT. Together, these articles can be defined as end-to-end qualification of the NTT process, demonstrating a high level of assurance that sterility is maintained from manufacture to point of use. Key Words: Aseptic processing, Design qualification, Good Manufacturing Practice (GMP), Life cycle, No-Touch Transfer (NTT), Pharmaceutical packaging, Pre-sterilised containers, Qualification, Quality by Design (QbD), Quality Risk Management (QRM), Ready-to-use (RTU), Supply chain


2021 ◽  
Vol 1 (12) ◽  
Author(s):  
Franciskus Antonius Alijoyo ◽  
Ivonne Bonita ◽  
Kevin Bastian Sirait

This study identified the risk management maturity status, revealed the major sources of the firm risk management maturity, issues in running quality risk management of a financial technology firm in Indonesia, and recommended enhancements. It used the Risk and Insurance Management Society – Risk Maturity Model to evaluate the risk management maturity status. To get detailed information about the risk management implementation, the researchers also did observations and interviews. This study confirmed that the firm was in ad-hoc status. The firm was overconfident of their previous success in implementing risk management and careless in transforming the risk management concepts into real practices. Thus, they lost their ability to decide appropriate decisions in handling the risks that they faced. As a result, they could not run effective and efficient management. Detail findings and recommendations on the risk management maturity of the firm are provided in this article.


2021 ◽  
Vol 25 (3) ◽  
pp. 85-100
Author(s):  
Yulia Yeni ◽  
Vera Pujani ◽  
Laura Syahrul

Purpose: The aim of this study is to predict perceived risk and consumer willingness in recommending takeaway food from restaurant served in buffet style.                           Methodology/Approach: This study used an online survey of 170 consumers who were selected based on purposive sampling method. The research questionnaire was adapted from previous research. The data were analysed using Structural Equation Modelling (SEM), with Smart PLS. Findings: The research findings show that health risk and psychological risk have a positive effect on intention to recommend takeaway food. Meanwhile, quality risk and trust have no effect on intention to recommend takeaway food. In addition, psychological risk and quality risk have no effect on trust. This study also shows that trust does not function as a mediator of the relationship between health risk, psychological risk, quality risk, trust, and intention to recommend. Research Limitation/Implication: This study only uses a self-report questionnaire by customers. For further research, to enrich the discussion, it is recommended to use interviews or FGD. In addition, this study only uses three risk variables. For the future, it is advisable to add other risk variables. Originality/Value of paper: In other countries such as China, Korea and the United States, related research has been carried out, however for the context of RM Padang which is unique with all the menus served (Buffet) on the visiting customers’ table has not been found in literature.


2021 ◽  
Vol 12 (6) ◽  
pp. 700-705
Author(s):  
Mariana De Oliveira Nunes ◽  
David M. Overman ◽  
Susan A. Casey ◽  
Dawn R. Witt ◽  
Christian W. Schmidt ◽  
...  

Background Patients with single ventricle (SV) congenital heart disease (CHD) undergo several interventions in the first years of life. Advanced diagnostics are required for interstage assessment of anatomy, but are associated with significant diagnostic risk. We sought to evaluate image quality, risk, and accuracy of cardiac computed tomography (CCT) for evaluation of anatomy prior to superior cavopulmonary connection (SCPC) compared to surgical findings across 2 institutions. Methods A retrospective evaluation of image quality, risk, and accuracy of pre-SCPC CCT was performed at 2 institutions between January 1, 2010 and September 30, 2016. Results CCT was performed in 90 SV CHD patients with a median age of 4.03 months (interquartile range [IQR] 3.36, 5.33) prior to SCPC. Image quality was optimal (84%) or good (16%) in all patients, without significant discrepancy compared to surgical findings. 7 patients (8%) required interventional cardiac catheterization subsequent to CCT and before surgical intervention. 49% of scans were performed without sedation, 43% of scans were performed with mild to moderate sedation, and 8% of scans were performed with general anesthesia. The median total procedural dose-length product (DLP) was 18 (IQR 14, 26) mGy*cm, estimating an age adjusted radiation dose of 1.4 millisievert (mSv). One minor (1%) adverse event was reported within 24 h of the CCT. Surgical complications were unrelated to the presurgical findings. Conclusions CCT for pre-SCPC evaluation is safe, with excellent accuracy for anatomy at the time of surgical intervention across 2 institutions. In select patients, noninvasive evaluation with CCT may be indicated.


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