Journal Club Template

For Randomized Controlled Trials

 Objectives
• < can simply cut and paste from those
listed at bottom of JC email>
 Background
• 1 or 2 slides only
Study Question
 Main Study Overview
• Patients - xx patients with y
• Randomized to Intervention versus ?
• Primary Outcome -
• Result - (primary outcome only)
• Their Conclusion
 Patients - Inclusion Criteria
• Describe – and then comment on how
well you think these criteria will capture
the patients of interest
 Patients - Exclusion Criteria
• Describe – and then comment on
whether you think this trial excludes
patients that would be of interest
 Randomization
• Was assignment of patients to
treatment randomized?
• Allocation concealment described?
– Allocation concealment means concealing
which group the next randomized patient
will be assigned to (it’s part of good
randomization; different from ‘blinding’,
discussed in later slides)
 Intervention
• What is it?
• What did the control group get?
 Outcomes
• Primary Outcome
– Can talk about sample size estimation here
(mention the minimal clinically important difference
that was sought)
• Secondary Outcomes

• Assessment of Outcomes:
– Who was blinded?
• Clinicians?
• Patients?
• Outcome assessors?
• Statistician?
 Follow-up
• Study Flow Diagram
• Were all patients accounted for at
conclusion?
• Was follow-up complete?
• Were patients analyzed in the group to
which they were randomized? (ITT?)
 Table 1
• Was randomization balanced for important
characteristics that might affect the primary
outcome?
– If different, we will want to know if they did an
adjusted analysis
• Are there important factors that might affect
OUTCOMES that do not appear in Table 1?
• Do these patients look similar to ones that we
would care for? (generalizability)
 Other Interventions
• Aside from the study intervention, were
groups treated similarly? (especially with
respect to therapies that might affect the
primary outcome)
– Cointerventions? (other interventions that might
affect outcome – were these applied similarly to
both groups)
– Contamination? (Did any patients randomized to
therapy x receive therapy y by mistake?)
– Compliance?
 What were the results?
• Primary outcome:
– How large was the treatment effect?
• Absolute risk reduction and Number needed to
treat
• Relative risk reduction
– How precise was the estimate of treatment
effect?
• Confidence intervals
 Other Outcomes
• Secondary outcomes
• Adverse Events
• Any outcomes that might be important
that aren’t reported?
– Were all clinically important outcomes
considered?
– Are any of the substitute outcomes valid?
 Will the results help me?
• Can the results be applied to my patient
care?
• Do I look after similar patients?
– Reflect on the inclusion/exclusion criteria
– reflect on your conclusions from review of
Table 1
 Will the results help me?
• Compelling reasons why the results shouldn’t
be applied to your patients?
– Reflect on other important outcomes that were not
assessed; adverse outcomes; etc.
• Are treatment benefits worth the potential
harms and costs?
– NNT again; consider number needed to harm
 Could we design a better study?
• Summary slide of your main criticisms –
– Does this topic require further study?
– If so, how could we answer the question BETTER
with a ‘dream study’…

– This is far more productive to focus on for journal

club discussions than that dreaded question: “Will
the results of this study change my practice?”
Your Conclusions!