Process-Oriented Knowledge Support in a Clinical Research Setting

Author(s):  
Sascha Muller ◽  
Stefan Jablonski
2019 ◽  
Vol 25 (4) ◽  
pp. 707-737
Author(s):  
Victor Cattani Rentes ◽  
Silvia Inês Dallavalle de Pádua ◽  
Eduardo Barbosa Coelho ◽  
Monica Akissue de Camargo Teixeira Cintra ◽  
Gabriela Gimenez Faustino Ilana ◽  
...  

Purpose This work explores the potential benefits of aligning the strategic planning process with a BPM program in a clinical research center (CRC). The purpose of this paper is to define a process for executing strategic planning oriented towards the promotion of a BPM program. Design/methodology/approach The method applied is action research. This allowed the solution of a practical problem and at the same time the proposition of a new approach to promote BPM in alignment with strategy, which was synthesized in the model presented. Findings The analysis and structuring of the strategic planning process, with the assessment of the as-is situation, were adequate as a preparation step for the first cycle of a BPM program in the CRC. Based on lessons learned along the research project, a model was proposed for the strategic planning process oriented towards promoting BPM. Research limitations/implications The model was conceived from a single application at a CRC, through a cycle of action research. This is one of the limitations of this work. The model was not yet sufficiently tested in other contexts. This represents opportunities for future research. Practical implications The evaluation step in the action research cycle revealed that the organization in focus was satisfied with the results. New management practices in the organizations in focus were implemented as a result of this work. Originality/value Process improvement initiatives are a novelty in the CRC context, and this work may serve as a reference for CRC managers seeking to improve overall performance. The proposed model in this work indicates that a BPM program should start with strategic planning. An initial assessment of the as-is situation of the organization in focus was performed based on the analysis of the undesirable effects in the organization’s management practices, using a technique of the Theory of Constraints. The use of this technique facilitated the identification of solutions to the root causes identified in the assessment. The level of the assessment was deeper in comparison to results obtained with traditional tools used in strategic planning processes. The assessment supports the definition of actions oriented to solving the majority of the management dysfunctions of the organization in focus.


2021 ◽  
pp. 104063872110447
Author(s):  
Kaela E. Shaw ◽  
Alexa M. Bersenas ◽  
Shane W. Bateman ◽  
Shauna L. Blois ◽  
R. Darren Wood

Our goal was to validate a human hyaluronic acid (HA) ELISA (Hyaluronic acid plus ELISA; TECOmedical Group) for use in feline plasma. Plasma from 5 healthy cats and 5 critically ill cats was used for validation of the assay. Validation methods performed included intra- and inter-assay variability, spike-and-recovery, and dilutional linearity. All measurements were performed in duplicate. The precision study revealed good intra-assay CV of 7.4–8.9%; inter-assay CV was 3.4–4.2%. Extraction efficiency via spiking tests yielded mean recovery of 89.6%. The assay met criteria for acceptable linearity using 3 serial dilutions. Our results demonstrate that this commercial HA ELISA had acceptable analytical performance using feline plasma and could be a useful tool in the veterinary clinical research setting.


1998 ◽  
Vol 36 (12) ◽  
pp. 3609-3613 ◽  
Author(s):  
Tânia A. T. Gomes ◽  
Mônica A. M. Vieira ◽  
Cecilia M. Abe ◽  
Daleth Rodrigues ◽  
Patricia M. Griffin ◽  
...  

The correlation between various adherence patterns and adherence-related DNA sequences in Escherichia coliisolates from 1- to 4-year-old children with and without diarrhea in São Paulo, Brazil, was evaluated. A total of 1,801 isolates obtained from 200 patients and 200 age-matched controls were studied. The adherence patterns found were classified as diffuse, aggregative, aggregative in a 6-h assay, aggregative predominantly in coverslips, localized, localized-like, and noncharacteristic. In general, the DNA sequences used as probes showed excellent specificities (>93%), but their sensitivities varied. Thus, the results of bioassays and assays with DNA probes normally used to search for adherent E. coli did not correlate well, and the best method for the identification of these organisms in the clinical research setting remains controversial. Isolates presenting diffuse adherence or hybridizing with the related daaC probe, or both, were by far the most frequent in patients (31.5, 26.0, and 23.0%, respectively), followed by isolates presenting aggregative adherence or hybridizing with the related EAEC probe, or both (21.5, 13.0, and 10.5%, respectively). None of the different combinations of adherence patterns and adherence-related DNA sequences found were associated with acute diarrhea.


2018 ◽  
Vol 36 (2) ◽  
pp. 103
Author(s):  
Rebecca Brown ◽  
Laurissa Stigen ◽  
Alanna Gerard ◽  
Kristin Erickson ◽  
Diane Treat-Jacobson ◽  
...  

2021 ◽  
Vol 36 (5) ◽  
pp. 1447-1449 ◽  
Author(s):  
Amerigo Vitagliano ◽  
Attilio Di Spiezio Sardo ◽  
Marco Noventa ◽  
Jose Carugno ◽  
Ettore Cicinelli ◽  
...  

2021 ◽  
Vol 6 (4) ◽  
pp. 245-251
Author(s):  
Laura Stiegel ◽  
Alison K. Klika ◽  
Carlos A. Higuera ◽  
Wael K.Barsoum ◽  
Nicolas S. Piuzzi

Medical progress, including in the orthopaedic surgery field, depends on the interaction and collaboration between: physicians, with their expertise on the clinical setting; scientists, with their expertise on the research setting; and professionals who are skilled in both settings (clinical scientists). This leads to the need to develop research approaches which involves people who are committed and support the process, strategic planning, and a cohesive team that can execute the tasks. All these interactions must be supported financially in order to maintain the long-term viability of such team. Time management is crucial for the clinical research team. To ensure success, the research team must be flexible in order to adapt to dynamic clinical and surgical schedules. It is especially important that surgeons have regular, dedicated quality research time to maintain a consistent interaction with the team. Building a successful and productive orthopaedic clinical research programme involves many challenges in creating proper leadership, obtaining funding, setting proper resources, establishing necessary training, and providing guidance and insight around the importance of each role that every member plays on the team. Cite this article: EFORT Open Rev 2021;6:245-251. DOI: 10.1302/2058-5241.6.200058


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