scholarly journals P64 Quality assessment for the continuous bioanalysis of aldosterone: application in an European paediatric study

2019 ◽  
Vol 104 (6) ◽  
pp. e43.3-e44
Author(s):  
N Makowski ◽  
I Burdman ◽  
M Ali ◽  
H Majid ◽  
S Farahani ◽  
...  

BackgroundA validation is crucial to ensure the quality of an analytical method and its results. However, the validation is only a first step, further quality assessment has to be utilised to ensure high quality research. Specifications for the validation process, but also for the assessment of data, acquired in a study setting, are given by the EMA and FDA to ensure highest quality of the data.1 2MethodsA multi-level analytical quality system was established. Data of the calibration standards (CSs), quality control samples (QCs), and incurred sample reanalysis (ISR) were evaluated according to the specifications given by the EMA and FDA guidelines.[1,2] For a run to be considered valid ≥6 levels or 75% of the CSs and 67% of the QCs (≥50% per level) had to vary ≤±20% (LLOQ ≤±25%) from their nominal concentration.[1,2] For the ISR analysis at least 67% of the ISR samples have to lay in ±30% to the nominal concentration of the mean of the original and reanalysed value.[1]ResultsSeventy analytical runs were conducted, applying the quality measures, 79% runs were classified as valid and were used to determine unknown samples in a paediatric study. The high quality of the acquired data is reflected in the high conformity of the CSs and QCs to the EMA and FDA guidelines, 99% of the CSs and 95% of the QCs were accepted. Further underlining the high quality of the acquired data, 85% of the IRS have also been accepted. The assay was successfully used over a time period of 29 months.ConclusionThe results of the quality assessment confirmed the robustness of the aldosterone assay throughout the whole study duration. Thus, the samples measured by this assay are reliable and facilitate the high quality research in the paediatric population.ReferencesGuideline on bioanalytical method validation. European Medicines Agency, London, UK (2011).Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA Rockville, MD, USA (2018).Disclosure(s)Nina Makowski, Ilja Burdman, Mohsin Ali, Bartel A, Bjoern B. Burckhardt declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA).

Author(s):  
Ruben Debeuf ◽  
Eva Swinnen ◽  
Tine Plattiau ◽  
Ann De Smedt ◽  
Elisabeth De Waele ◽  
...  

Objective: Guidelines regarding physical therapy for COVID-19 patients are often based on expert opinion. Recent clinical trials have reported effects on several rehabilitation outcomes in COVID-19 patients. This review summarizes the effects of physical therapy in COVID-19 patients. Data sources: PubMed, Web of Science and Scopus databases were systematically searched for studies investigating the effect of any physical therapy modality on impairments in adult COVID-19 patients. Included studies were (non)-randomized controlled trials, pre-experimental studies, and cohort studies in which a pre–post analysis was performed. Data extraction: After the screening process, data of interest were extracted from eligible studies and their risk of bias was assessed. Included outcome measures were divided into 3 groups: pulmonary function, physical function, and psychosocial function. Data synthesis: A total of 15 studies were included in this review. Physical therapy seems to have positive effects on pulmonary function, physical function, and psychosocial function. However, these effects differ between clinical settings (e.g. home care, intensive care unit, inpatient units). Due to the low-to-moderate quality of the included studies, no robust conclusions can be drawn. Conclusion: Further high-quality research is required, taking into account the different clinical settings, in order to draw conclusions about the effectiveness of physical therapy on impairments in COVID-19 patients.   Lay Abstract Guidelines regarding physical therapy for COVID-19 patients are often based on expert opinion or on evidence from studies of physical therapy in patients with other diseases. More and more clinical studies are investigat-ing the effect of physical therapy on the recovery of COVID-19 patients. Prior to this review, the importance of physical therapy for COVID-19 patients was not clear. This review summarizes the effects of physical therapy in COVID-19 patients. We reviewed and assessed the quality of the existing literature on this topic. Fifteen studies with a total of 1,341 COVID-19 patients were included in this review. Physical therapy appears to improve lung function, physical function, and psychosocial func-tion in COVID-19 patients. However, the effect can differ between clinical settings; for example, home care, intensive care unit, or other inpatient units. Due to the low-to-moderate quality of the included studies, no robust conclusion can be drawn. Further high-quality research is needed, taking into account the different clinical settings.


2015 ◽  
Vol 6 (10) ◽  
Author(s):  
Ana Paula Cabral ◽  
Isabel Huet

Most quality assessment systems are based on an explicit separation of teaching/learning and research; however, in spite of their having enhanced both the organisation and quality improvement of each of these fields, they have also been contributing to a widening of the gap between the two and to the devaluation of teaching.The present study, developed in the UK, intends to provide some insights into the perceptions of former panel members, managers and academics, as they anticipate the impacts from REF 2014. Increasing pressure to achieve high-quality research has been leading institutions to hire the most prestigious researchers. Were there to be equivalent effort to achieve parity in the quality of teaching, this situation might be less worrying, for teaching does not currently enjoy the same investment; rather, its very inferiority is considered to have an even more negative impact on the development of new practices, as well as on student learning and support.


2014 ◽  
Vol 16 (2) ◽  
pp. 352-356 ◽  
Author(s):  
Joseph F. Bower ◽  
Jennifer B. McClung ◽  
Carl Watson ◽  
Takahiko Osumi ◽  
Kátia Pastre

Author(s):  
Ihsan Ekin Demir ◽  
Güralp O. Ceyhan ◽  
Helmut Friess

Abstract Background Surgeons are frequently compared in terms of their publication activity to members of other disciplines who publish in journals with naturally higher impact factors. The time intensity of daily clinical duties in surgery is yet not comparable to that of these competitor disciplines. Purpose Here, we aimed to critically comment on ways for improving the academic productivity of university surgerons. Conclusions To ensure high-quality science in surgery, it is imperative that surgeons actively ask for and generate the time for high-quality research. This necessitates coordinated and combined efforts of leading university surgeons at the political level and effective presentation of the magnificent studies performed by young and talented university surgeons.


2021 ◽  
Vol 75 (6) ◽  
Author(s):  
Stacey Reynolds

The American Journal of Occupational Therapy (AJOT) retains its ranking as the top-rated occupational therapy journal in North America by maintaining its commitment to publishing high-quality research aimed at occupational therapy professionals. As the needs and scope of the profession continue to expand, AJOT will continue to serve as a resource to practitioners, academics, and administrators to help guide best practices. Communication and engagement with readers will be facilitated through the new AJOT website as well as the new AJOT: Authors and Issues series. The journal seeks to expand its scope through its website, manuscript submission platform, and new ways to engage readers.


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