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Ortodonzia e Implantologia
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Randomized ContRolled
tRials (RCts)
in the Context of evidenCe based
dentistRy
fiRenze may 23-24 2016
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ISO Istituto Studi Odontoiatrici
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II S TSI T UO
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Key elements and critical
appraisal of published rCTs
®
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ODONTOIATRICI
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IT-57-15
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II S TSI T UO
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niKOlaOS PandiS
Randomized Controlled
Trials (RCTs)
in the Context of Evidence
based Dentistry
Key elements and critical
appraisal of published RCTs
Randomized clinical trials (RCT) are considered as the
best experimental method to investigate the efficacy
and safety of an intervention of interest; RCTs form the
backbone of systematic reviews. The superiority of the
RCT hinges upon the use of randomization in treatment
allocation, the use of controls, the prospective patient
monitoring, and the analysis and presentation of
data based on a pre-specified and rigorous plan that
reduces systematic errors.
This course will present the randomized controlled
trial in the context of evidence based dentistry and the
fundamentals on design and reporting of RCTs will be
explored. Common errors in the design, analysis and
interpretation of clinical research will be discussed
and a practical which will include critical assessment
of 1-2 published dental RCTs will conclude the course.
Aim of the course
To provide the necessary skills to be able to critically
appraise published clinical trials.
Contents
Prof. Nikolaos Pandis
Part 1
- Introduction to Evidence Based Dentistry
- Types of clinical studies
[randomized, non-randomized or observational]
- Confounding, types of Bias in clinical trials, Rando
mization, Blinding, Sample size calculation, Subgroup
analyses, Confidence intervals rather than p-values,
common errors in clinical trials
[ignoring clustering, change from baseline]
- Importance of accurate and transparent reporting and
the CONSORT reporting guideline for clinical trials.
- Short introduction to Systematic Reviews
Part 2
- One or two published RCT will be appraised and the
information from part 1 will be applied.
- This part will be interactive and the article will be
assessed using the AJODO RCT appraisal form.
Ideally, the participants should prepare for this
exercise in advance
- Short review of the course learning objectives
Degree of dental surgery:
University of Athens, Greece
Orthodontic specialty certificate:
The Ohio State University, USA
Master’s of Science (MS) in orthodontics:
The Ohio State University, USA
Fellowship in craniofacial orthodontics:
University of Texas, Dallas, USA
Dr. med dent in orthodontic biomechanics:
University of Bonn, Germany
Master’s of Science (MSc) in clinical trials:
London School of Hygiene & Tropical Medicine, UK
Visiting assistant professor:
Orthodontic department, University of Bern, Switzerland
External tutor for the master’s in clinical trials:
London School of Hygiene & Tropical Medicine, UK
Diplomate of the American Board of Orthodontics
Reading material:
1. RCT relevant articles and CONSORT paper to
help better understand and follow the presentation
(included in folder reading material)
2. Two papers which will be critically appraised using
the AJODO form (included in folder appraise)
The reading material will be sent by email to the
registered participants about 10 days before the
course. The participants are also invited to bring
their own laptop to the Course in order to interact
with the speaker during the practical sessions.
PhD in Epidemiology: Department of Hygiene &
Epidemiology, Medical School, University of Ioannina,
Greece
Associate Editor in the American Journal of
Orthodontics and Dentofacial Orthopedics (AJODO):
RCT submissions handling and monthly column on
research design methodology
Publications:
Over 180 scientific publications in peer-reviewed
biomedical journals and 2 published books in clinical
orthodontics and clinical research methodology