Epidemiology-Biostatstics Small Group Session 6: Evaluating a Randomized Controlled Trial
Outside Preparation:
- Review lecture notes from Lecture 1 - Critiquing a Randomized Contorlled Trial on critiquing RCTs
- Read the assigned paper: Evaluation of Acupuncture for Pain Control After Oral Surgery; Arch Otolaryngol Head Neck Surg; 5-99, Vol 125, pages 567-572; bring a copy of the article to small group
Approximate Class Schedule:
| 30 minutes | Instructor review of key concepts from Lecture 12 |
| 30 minutes | The class will be divided into small groups. Each group will critique the paper. |
| 30 minutes | Class discussion on critique |
To Be Completed in Small Group Sessions
Answer the following questions pertaining to the assigned paper:
- Did the subjects likely meet entry criteria as defined by the authors? If yes, explain your answer. If not, explain your answer and indicate how this might have lead to erroneous trial conclusions.
- Were the study arms comparable? If yes, explain your answer. If not, explain your answer and indicate how this might have lead to erroneous trial conclusions.
- What was the loss to follow-up?
- Was compliance assessed? If yes, explain your answer. If no, explain your answer and indicate how this might have lead to erroneous trial conclusions.
- Was the study blinded? If yes, explain your answer. If no, indicate how this might have lead to erroneous trial conclusions.
- Do you agree with the study’s definition of the outcome? If yes, explain your answer. If no, indicate how this might have lead to erroneous trial conclusions.
- If the study results were not statistically significant, did the study report the power?
- Comment on the external validity of this paper. (For purposes of this exercise, provide comments even if you believe the internal validity was poor.)


