APPRAISAL LENS FOR AN ARTICLE ON THERAPY

Are the results valid? 1. Were patients randomized to treatment groups? Why is it Imp rta!t Randomization makes the treatment and control groups equal with regards all known or unknown prognostic factors. Concealment of the allocation helps protect the process of randomization. What t L " F r Look for the word randomize in methods.

2. Was randomization concealed?

Look for strategies such as use of opaque envelopes randomization !" third part" or randomization !" computer. &rop$outs should !e stated e'plicitl" in a paper. %f not compare num!er randomized with num!er of patients anal"zed at end of stud". ( sensitivit" anal"sis ma" help readers decide if follow$up is adequate. Look for the term +intention$to$treat, under the planned anal"sis. %f not stated make sure the num!er randomized is equal to num!er of patients anal"zed at end of stud". Look for !linding strategies such as use of a place!o. 0his ma" not alwa"s !e feasi!le or necessar". Look for !linding strategies such as use of a place!o. 0his ma" not alwa"s !e feasi!le or necessar". Look for strategies to withhold information regarding patient assignment.

#. Was follow$up rate adequate?

%f there are too man" drop$outs with unknown outcome the validit" of a stud" is threatened.

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Were patients anal"zed under the groups to which the" were originall" randomized?

*on$compliant patients should !e evaluated as if the" received a treatment !ecause non$compliance is part of the effect of treatment.

-. Were patients !linded to group allocation?

1. Were clinicians !linded to group allocation?

.linding patients is necessar" especiall" when su!/ective complaints are measured as outcomes. .linding caregivers is necessar" in order to equalize the care that patients receive. .linding outcome assessors separatel" ma" !e necessar" especiall" when patients and caregivers cannot !e !linded.

2. Were outcome assessors !linded to group allocation?

3. Were patients in the treatment and control groups similar with respect to known prognostic varia!les?

0his comparison assesses compara!ilit" of the groups !eing compared. 0he magnitude of an" difference is more important than the reported p$value. Why is it Imp rta!t 4ow the num!ers are e'pressed affects our appreciation of effectiveness.

Look for a comparison in ta!les or in the te't.

What are the results? 1. 4ow large was the treatment effect?

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5or dichotomous outcomes 6 look for Relative Risk Relative Risk Reduction and (!solute Risk Reduction 7also known as risk difference8. 5or continuous outcomes 6 look for the mean difference. 9ften "ou ma" need to estimate this "ourself. Look for <-= confidence intervals. 9ften "ou ma" need to estimate this "ourself using an >.? calculator.

2. 4ow precise was the estimate of the treatment effect?

:tudies /ust estimate effectiveness. ;recision gives us the !est and worst scenarios in terms of effectiveness of the treatment !eing evaluated. Why is it Imp rta!t ?an" times the patient "ou are managing the treatment "ou are a!out to use or the outcome "ou are tr"ing to prevent $ are not e'actl" the same as those studied !" the authors of a paper. %n this situation "ou need to decide if "ou can use the stud" results at all. 0he decision requires some e'pertise on the disease under question.

H # $a! y u apply the results t patie!t $are? 1. &oes the stud" provide a direct enough answer to "our clinical question in terms of t"pe of patients intervention and outcomes?

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:eek the opinion of an e'pert 7this might !e "ou8 or "our colleagues.

2. Were the stud" patients similar to the patients in "our practice? a. Look for !iologic differences in the illness under stud" that ma" alter "our patient@s treatment response. &iseases referred to !" the same name ma" actuall" have important differences in !iolog". 5or e'ample malaria in the ;hilippines ma" have a different sensitivit" to treatment compared to malaria in Aim!a!weB h"pertension in !lacks differs in treatment response when compared to h"pertension in whites. >ven if disease !iolog" is the same there ma" !e patient differences that alter treatment response for e'ample genetic differences in pharmacokinetics such as the rate of acet"lation of some drugs. >ven if disease !iolog" and patient response to treatment is the same patients ma" have concurrent diseases that alter the accurac" of diagnosis or the effectiveness of treatment. 5or e'ample malnourished patients ma" not respond ver" well to vaccinations. &ifferences in !aseline risk for a particular outcome ma" lead to significant differences in risk difference **0 and cost$ effectiveness. :ometimes the outcomes measured in a stud" /ust measure intermediate outcomes that do not directl" tell us if patients feel !etter or live longer. Look for descriptive studies on !iolog" and causation of the illness.

!. Look for !iologic differences among patients that ma" alter their treatment response.

Look for descriptive studies on varia!ilit" of treatment response.

c. Look for co$mor!id conditions that ma" significantl" alter "our patient@s treatment response.

Look for descriptive studies on the effect of concurrent illnesses on varia!ilit" of test accurac" or treatment response.

d. Compare the incidence of the outcome in untreated patients in "our target population with that of the control group in the stud". #. Were all clinicall" relevant outcomes considered?

Cnowledge on the !aseline incidence of an outcome in the target population ma" come from previous clinical trials cohort studies or prevalence surve"s. Look for outcomes that tell us if patients feel !etter 7qualit" of life8 or live longer 7quantit" of life8. (lso look for adverse events !ecause these are often overlooked.

). (re the likel" treatment !enefits worth the potential harm and costs?

>ven if a treatment is !eneficial it ma" have adverse effects or it ma" !e too e'pensive.

>stimate the num!er needed to treat. ?ultiplied !" cost of treatment 7and duration when relevant8 this gives us an idea of overall cost to prevent an event. *oteD "ou ma" need to use a local estimate of !aseline risk rather than the !aseline risk used in the stud".