Annotated Users' Guide: Therapy/Prevention
Return to Main Page

Are the results valid?
What are the results?
Will the results help patient care?
Are patient's values satisfied by the regimen?
Estimating the Size of the Treatment Effect

Are the results valid?

Was the assignment of patients to treatment randomized?

• and was the randomization list concealed?

Were all patients who entered the trial accounted for at its conclusion?

• Was follow-up complete?
• Were patients analyzed in the groups to which they were randomized (Intention to treat analysis)?

Were patients, their clinicians and study personnel 'blind' to treatment?

Were the groups similar at the start of the trial?

• Baseline prognostic factors (demographics, co-morbidity, disease severity, other known confounders) balanced?
• If different, were these adjusted for?

Aside from the experimental intervention, were the groups treated equally?

• Co-intervention?
• Contamination?
• Compliance?

Return to top

What are the results?

How large is the treatment effect?

• Absolute risk reduction?
• Relative risk reduction?

How precise is the estimate of the treatment effect?

• Confidence intervals

Return to top

Can I apply this valid, important evidence in caring for patients?

Do these results apply to your patients?

• Are trial patients similar for demographics, severity, co-morbidity and other prognostic factors?
• Compelling reason why the evidence should not be applied?

Were all clinically relevant outcomes considered?

• Are substitute endpoints valid?

Are the benefits worth the harms and costs?

• How great would the potential benefit of therapy be for your patients?
• NNT for different outcomes?
• Risk of outcome in your patient relative to patients in the trial (NNT/F)=
• Your patient's expected event rate (PEER) if they received the control treatment: 1/(PEERxRRR)=

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

• Do your patient and you have a clear assessment of their values and preferences?
• Are they met by this regimen and its consequences?

Search Strategies: Tx
Return to top
Return to Main Page