Escolar Documentos
Profissional Documentos
Cultura Documentos
Hohnloser SH, Connolly SJ, Crijins HJGM et al. Rationale and Design of
ATHENA: A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the
Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular
Hospitalization or Death from Any Cause in Patients with Atrial
Fibrillation/Atrial Flutter. J Cardiovasc Electrophysiol 2008; 19: 69-73
The CASP critical appraisal study tool for RCTs is available online at:
http://www.sph.nhs.uk/what-we-do/public-health-workforce/resources/critical-
appraisals-skills-programme
The questions in this exercise are based on the questions in the CASP study
tool. In future you can use the questions below to evaluate an RCT or you can
access the tool online at the above address.
Screening Questions
The first two questions are screening questions and if the answer to either of
these is no then the study may be of limited usefulness.
Methodology
(a) How were participants allocated to the intervention and control groups?
Was the process truly random?
(b) Was stratification used?
(c) How was the randomisation schedule generated and how were
participants allocated to intervention and control groups?
(d) Are the groups well balanced? Are any differences reported between
the groups at entry to the trial?
(e) Are there any differences that may confound the result?
Q4. Were participants, staff and study personnel blind to participants study
group?
Consider:
Blinding is not always possible
If every effort was made to achieve blinding
Does it matter in this study i.e. could there be observer bias?
Q6. Were the participants in all groups followed up and the data collected in
the same way?
Q7. Did the study have enough participants to minimise the play of chance?
i.e. is there a power calculation?
Results
Q8. How are the results presented and what is the main result?
Relevance
Once we have assessed the quality of the methodology and considered the
importance of the results, we should think about how the results could be
applied to our local population and whether a change in practice seems
justified.
Q10. Were all important outcomes considered so the results can be applied?
(a) Were the people included in the trial similar to your population?
(b) What was the comparator and was it suitable?
(c) Was the study and follow-up of an appropriate duration for the
disease state and intervention under review?
(d) Does the setting of the trial differ from your local setting?
(e) Could the same treatment be provided in your local setting?
(f) Do the benefits of this treatment outweigh the risks/costs?
(g) Should policy or practice change as a result of the evidence
contained within this trial?