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Centre for Evidence-
Based Medicine

Completed Therapy Worksheet for Critical Care Medicine

Are the results of this single preventive or therapeutic trial valid?

  1. Was the assignment of patients to treatments randomised? And was the randomisation list concealed?
    Yes
  2. Were all patients who entered the trial accounted for at its conclusion? And were they analysed in the groups to which they were randomised?
    Yes
  3. Were patients and clinicians kept "blind" to which treatment was being received?
    No
  4. Aside from the experimental treatment, were the groups treated equally?
    Yes
  5. Were the groups similar at the start of the trial?
    Yes

Are the valid results of this randomised trial important?

Sample Calculations

Occurrence of diabetic neuropathy Relative Risk Reduction (RRR) Absolute Risk Reduction (ARR) Number Needed to Treat (NNT)
Usual Insulin
Control Event Rate (CER)
Intensive Insulin
Experimental Event Rate (EER)
(CER - EER)/CER CER-EER 1/ARR
9.6% 2.8% (9.6%-2.8%)/9.6%
= 71%
9.6% - 2.8%
= 6.8%
[4.3% to 9.3%]
1/6.8%
= 15 pts
[11 to 23]

95% Confidence Interval (CI) on an NNT = 1 / (limits on the CI of its ARR)
= +-1.96 sqrt(((CERx(1-CER))/(# of control pts.)) + ((EERx(1-EER))/(# of exper. pts.)))
= +-1.96 sqrt(((0.096x0.904)/730) + ((0.028x0.972)/711))
= ±2.4%

Your Calculations

Relative Risk Reduction (RRR) Absolute Risk Reduction (ARR)
[95% CI]
Number Needed to Treat (NNT)
[95% CI]
CER EER (CER - EER)/CER CER-EER 1/ARR
23.3% 18.7% (23.3% - 18.7%)/23.3%
= 19.7%
4.6%
[-0.8% - 10.2%]
22
[NNT 10 to infinity, NNH 110 to infinity]

Can you apply this valid, important evidence about a treatment in caring for your patient?

Do these results apply to your patient?

  1. Is your patient so different from those in the trial that its results can't help you?
    No

How great would the potential benefit of therapy actually be for your individual patient?

  1. Method I: f
    Risk of the outcome in your patient, relative to patients in the trial. expressed as a decimal: 1.0

    NNT/F
    = ________
    = 22 (but note confidence interval included infinity)
    (NNT for patients like yours)
  2. Method II: 1 / (PEER x RRR)
    Your patient's expected event rate if they received the control treatment:

    PEER:______
    1 / (PEER x RRR)
    = 1/________
    = __________

    (NNT for patients like yours)

Are your patient's values and preferences satisfied by the regimen and its consequences?

  1. Do your patient and you have a clear assessment of their values and preferences?
    Needs to be assessed in each patient
  2. Are they met by this regimen and its consequences?
    Needs to be assessed in each patient

Additional Notes

The study was an equivalency study designed to detect an absolute difference in mortality of 5.5% between the treatment and control groups. Therefore, we can say that liberal transfusion is not associated with a 5.5% difference in mortality but can not comment on if there is a smaller treatment effect. Although the study was under powered to detect treatment effects less than 5.5%, a treatment effect less than 5.5% may be clinically meaningful since the outcome is mortality.

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