INTRO TO JOURNAL

CLUB
Mohammad Paryavi, PGY3
Marisa Oishi, MD

Outline
Primary Research
Observational Studies
How to make sense of a cohort
Experimental Studies (RCTs)
How to make sense of RCTs
Secondary Research
What is a Meta-analysis?

Observational Studies
Cohort
Case-controlled
Cross sectional

Cohort Study
Group of people followed over time.
Subjects who are not at risk for developing the outcome

should be excluded from the study

Selection is to have both the exposed and unexposed
groups be selected from the same source population

Cohort Study Advantage/Disadvantages

Case-Control Study

Cross Sectional Studies

Make Sense Of a Cohort Study?

Are the results valid?
What are the results?
Will the results help locally?

Are The Results Valid?

Did the study address a clearly focused issue?
What outcomes were studied?
Primary outcome
Secondary outcomes

Did the authors use an appropriate method to answer

their question?
Is a Cohort a good way to answer the question?
Was the question addressed?

Are The Results Valid?

Was the cohort recruited in an acceptable way?
Was the exposure accurately measured to minimize bias?
Objective or Subjective?
Was the outcome accurately measured to minimize bias?
Objective or Subjective?

Are The Results Valid?

Have the authors identified all important confounding

factors?

Are The Results Valid?

Some other confounders not included:
Graft size
Smoking/drinking habits
Medication use
Sports activity during f/u
Have they taken account the confounding factors in the

design and/or analysis?

Are The Results Valid?

Was the follow up subjects complete enough?
Was the follow up subjects long enough?

What Are The Results?

Results (Primary Outcome)?
HT grafts increased from 68% in 2005 to 85% in 2011
Revision rates
HT=1 and 5 years were 0.65% (95% confidence interval [CI], 0.51%-

0.82%) and 4.45% (95% CI, 3.94%- 5.01%)

PT=1 and 5 years were 0.16% (95% CI, 0.05%-0.50%) and 3.03% (95%
CI, 2.27%-4.05%)
Overall Adjusted RR = 1.41 (95% CI, 1.03-1.92)
Adjusted RR = 1 and 5 years was 3.82 (95% CI, 1.20-12.2) and 1.90
(95% CI, 0.43-8.40),
Bottom line:
4X increased risk of revision at 1-year follow up in HT group compared

to PT group.
Minor difference in OVERALL risk of revision when adjusting
confounders

What Are The Results?

Results (Secondary Outcome)?
KOOS
HT: 62.6 (95% CI, 61.7-63.5)
PT: 58.0 (95% CI, 56.2-59.7)

Tegner scores
HT: 4.9 (95% CI, 4.9-5.0)
PT: 4.7 (95% CI4.6-4.9)
Pivot-shift Test
HT: 16%+
PT: 19%+
Adjusted OR=0.81 (95% CI, 0.68-0.96)

Bottom line:
Slightly less pain, increased stability and increased quality of life in HT group.

What Are The Results?

How precise are the results?
Confidence Intervals
Do you believe the results?
Is it biologically plausible?
Is there a big difference between the groups?
Can it be due to bias, chance, or confounding?
Any big flaws in the study?

Will It Help Me Locally?

Apply to local population?
Results fit with other available evidence?

Experimental Studies
Randomized controlled trials
Parallel-group each participant is randomly assigned to a

group, and all the participants in the group receive (or do

not receive) an intervention.
Crossover over time, each participant receives (or does
not receive) an intervention in a random sequence.
Cluster pre-existing groups of participants (e.g., villages,
schools) are randomly selected to receive (or not receive)
an intervention.
Factorial each participant is randomly assigned to a
group that receives a particular combination of
interventions or non-interventions

RCTs-Advantages
Eliminates Bias
Facilitates Blinding
Helps distinguish if results are merely

due to chance
Most reliable form of scientific
evidence in the hierarchy of evidence
Influence healthcare policy and
practice

RCTs-Limitations
External Validity
Cost
Time
Industry sponsored

RCTs-Are they really superior?

There were 136 reports about 19 diverse treatments

In most cases, the estimates of the treatment were similar

RCTs-Publication Bias

RCTs-Validity
Similar to making sense of cohort study
FRISBE
F: Patient Follow-Up
Were all patients who entered the trial properly accounted for and attributed at its conclusion

(losses to follow-up should be less than 20%)?

Was follow-up complete?

R: Randomization
Were the recruited patients representative of the target population?
Was the allocation (assignment) of patients to treatment randomized?
Was the allocation concealed?

I: Intention to treat analysis

Were patients analyzed in the groups to which they were randomized?
Were all randomized patient data analyzed? If not, was a sensitivity or worst case scenario analysis

done?

RCTs-Validity
S: Similar Baseline Characteristics of Patients
Were groups similar at the start of the trial?
B: Blinding
Were patients, health workers, and study personnel blind to

treatment?
If blinding was impossible, were blinded raters and/or objective
outcome measures used?

E: Equal Treatment
Aside from the experimental intervention, were the groups treated
equally?

Secondary Research
Meta-Analysis