Therapautic Appraisal Tools

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THERAPY WORKSHEET Citation: Are the results of this single preventive or therapeutic trial valid? Was the assignment of patients to treatments randomised? Was the randomisation list concealed? Was follow-up of patients sufficiently long and complete? Were all patients analysed in the groups to which they were randomised? Were patients and clinicians kept “blind” to treatment? Were the groups treated equally, apart from the experimental treatment? Were the groups similar at the start of the tria
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  THERAPY WORKSHEETCitation:Are the results of this single preventive or therapeutic trial valid? Was the assignment of patients totreatments randomised?Was the randomisation list concealed?Was follow-up of patients sufficientlylong and complete?Were all patients analysed in the groups towhich they were randomised?Were patients and clinicians kept “blind”to treatment?Were the groups treated equally, apartfrom the experimental treatment?Were the groups similar at the start of thetrial? Are the valid results of this randomised trial important?SAMPLE CALCULATIONSOccurrence of diabeticneuropathy at 5 years amonginsulin-dependent diabetics inthe DCCT trialRelative risk reduction(RRR)Absolute risk reduction(ARR)Numberneeded totreat (NNT) Usual insulinregimencontrol eventrate (CER)Intensive insulinregimenexperimentalevent rate (EER)CER – EER CER CER-EER1/ARR 9.6%2.8%9.6% - 2.8%9.6%= 71%9.6% - 2.8%= 6.8%1/6.8%= 15 patients 95% CI * ⇒ 4.4% to 9.2%11 to 23 * 95% confidence interval (CI) on an NNT = 1/(limits on the CI of its ARR) =YOUR CALCULATIONS %4.2 711972.0028.0 730904.096.0 96.1#)1(#)1(96.1 ±=     ×+     ×±=      −×+      −×± ofExperPts EER EERtsofControlP CERCER  Relative risk reduction(RRR)Absolute risk reduction(ARR)Numberneeded totreat (NNT) CEREERCER – EER CER CER-EER1/ARR  95% CI ⇒ Can you apply this valid, important evidence about therapy in caring for yourpatient? Do these results apply to your patient?Is your patient so different from those inthe study that its results cannot apply?Is the treatment feasible in your setting?What are your patient’s potential benefits and harms from the therapy? Method I  : f  Risk of the outcome in your patient,relative to patients in the trial.Expressed as a decimal: ______  NNT/f = ______ / ______ = ______ (NNT for patients like yours) Method II  : 1/(PEER x RRR) Your patient’s expected event rate if theyreceived the control treatment (PEER)= ______ 1/(PEERxRRR) = 1/________ = ______ (NNT for patients like yours)Are your patient’s values and preferences satisfied by the regimen and itsconsequences?Do your patient and you have a clear assessment of their values and preferences?Are they met by this regimen and itsconsequences? Additional notes:
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