Observational Safety Study Design, Analysis, and Reporting

2014 ◽  
pp. 142-157
Keyword(s):  
Study Design ◽  
Design Analysis ◽  
Safety Study

scholarly journals Management of Patients under Treatment with Monoclonal Antibodies and New Biological Therapies

2021 ◽  
Vol 11 (11) ◽  
pp. 4865
Author(s):  
Marta Amigo-Basilio ◽  
Covadonga Álvarez-González ◽  
Carlos Cobo-Vázquez ◽  
Isabel Leco-Berrocal ◽  
Luis Miguel Sáez-Alcaide ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Conservative Treatment ◽  
Adverse Effects ◽  
Adverse Events ◽  
Oral Cavity ◽  
Study Design ◽  
Biological Therapy ◽  
Design Analysis ◽  
Biological Therapies ◽  
Analysis Of Cases

Objective: The aim of this study is to know the biological therapy drugs that are related to adverse events, what dental treatments are associated with the appearance of these events, their severity, and how they are resolved. Study design: Analysis of cases described in the literature on patients undergoing treatment with biological therapies who have developed adverse effects associated with these drugs. Results: Of the 62 articles reviewed, 49 describe 68 cases of MRONJ, most of which appeared in the jaw and received surgical and/or conservative treatment. Conclusions: Biological therapies can potentially develop adverse effects in the oral cavity, so strict monitoring by the dentist is necessary.

scholarly journals Method-comparison studies in telehealth: Study design and analysis considerations

2017 ◽  
Vol 23 (9) ◽  
pp. 797-802
Author(s):  
Trevor G Russell ◽  
Melinda Martin-Khan ◽  
Asaduzzaman Khan ◽  
Victoria Wade
Keyword(s):  
Clinical Practice ◽  
Data Analysis ◽  
Study Design ◽  
External Validity ◽  
Best Practice ◽  
Method Comparison ◽  
Design Analysis ◽  
Data Types ◽  
Analysis Techniques ◽  
Practice Method

When establishing telehealth services, clinicians need to be confident that the examinations, assessments and clinical decisions that they make while using technology are equivalent to conventional best practice. Method-comparison studies are ideally suited to answering these questions, however there is a lack of consistency in the telehealth literature in the study methodologies and data analysis techniques used. Methodologies should closely match clinical practice to maximise external validity and data analysis techniques should match the data types generated in order to be clinically meaningful. In this article we discuss the design, analysis and interpretation of method-comparison studies in the context of telehealth research.

scholarly journals Desloratadine Exposure and Incidence of Seizure: A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015

Drug Safety ◽  
2021 ◽  
Author(s):  
Annette Kjær Ersbøll ◽  
Kaushik Sengupta ◽  
Eero Pukkala ◽  
Kristian Bolin ◽  
Eline Aas ◽  
...  
Keyword(s):  
Cohort Study ◽  
Study Design ◽  
Safety Study ◽  
Cohort Study Design

scholarly journals Low and standard pressure pneumoperitoneum effects during laparoscopic procedures: Problems of study design, analysis and presentation of results

2016 ◽  
Vol 30 ◽  
pp. 45-47
Author(s):  
Isabel C. Gerntke ◽  
Marina Yu Eliseeva ◽  
Ioannis P. Kosmas ◽  
Alexey A. Ivanov ◽  
Tahar Benhidjeb ◽  
...  
Keyword(s):  
Study Design ◽  
Design Analysis ◽  
Laparoscopic Procedures ◽  
Standard Pressure
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