EBM - Therapy

Iwan Dwiprahasto/Andaru Dahesihdewi

CEBU Faculty of Medicine Gadjah Mada University
Yogyakarta
Critical Appraisal for Therapy
Using the worksheet

Three day versus five day treatment

with amoxicillin for non severe
pneumonia in young children: a
multicentre randomised controlled
trial
Independent work: EBM worksheet
for therapy

2 JOURNALS
CONSORT
CONSORT

CONSORT = Consolidated Standards Of

Reporting Trial

22 items
Title/abstract
Methods
Results
Discussion

http://www.consort-statement.org/
BMJ 2004; 328 : 791
1. Title / Abstract
2. INTRODUCTION - background
3. METHODS participants
4. METHODS Interventions
5. METHODS Objectives
6. METHODS Outcomes
7. METHODS sample size
8-10. METHODS randomization
11. METHODS Blinding
12. METHODS Statistical Methods
13. RESULTS Participant flow
14. RESULTS recruitment
15. RESULTS
Baseline data
(table 1)
16. RESULTS Number analyzed
INTENTION TO TREAT ANALYSIS

a type of analysis of clinical trial data in

which all patients are included in the
analysis based on their original assignment
to intervention or control groups,
regardless of whether patients failed to
fully participate in the trial for any reason,
including whether they actually received
their allocated treatment, dropped out of
the trial, or crossed over to another group.
16. RESULTS Number analyzed
17. RESULTS Outcomes
18.
RESULTS
Ancillary
analysis
19. RESULTS Adverse events
21. DISCUSSION Interpretation
21-22. DISCUSSION generalizability and
overall
evidence
CRITICAL APPRAISAL
BMJ 2004; 328 : 791
 Methods-1
Randomized, placebo controlled trial, multicentre,
double blind

2188 children 2-59 months

cough, rapid respiration or

Subjects : difficulty in breathing

Non severe pneumonia:

respiratory rate 50/min
(2-11) or 40/min (12-59)

Interventions:
Oral amoxicillin 31-54mg/kg/day in 3 divided dose.
1095 subject given 3 days and 1093 subjects given
five days
Methods-2
Severe pneumonia

Condition requiring AB

Excluded Congenital heart disease

Chronic systemic disorder

Using AB and allergy penicillin

Asthma & measles

Methods-3
OUTCOMES : treatment failure

development chest indrawing, convulsions,

drowsiness, or inability to drink, respiratory
rate above age specific cut points on day-3 or
later, or oxygen saturation by pulse oximetry <
90% on day 3

3 and 5 days after enrollment

FOLLOW UP
12 and 14 days after enrolment
 EBM Therapy Worksheet

I. Are the results of this single or

therapeutic trial valid? (V)

II. Are the valid results of this

randomized trial important? (I)

III. Can you apply this valid,

important evidence about therapy in
caring for your patient? (A)
I. Are the results of this single or
therapeutic trial valid?

1. Was the assignment of patients to

treatments randomized?

2. Was the randomization list concealed?

3. Was follow-up of patients sufficiently

long and complete?

4. Were patients analyzed in the groups to

which they were randomized?
I. Are the results of this single or
therapeutic trial valid?

5. Were patients, clinicians and study

personnel "blind" to treatment?

6. Were the groups treated equally, apart

from the experimental treatment?

7. Were the groups similar at the start of

the trial apart from the experimental
therapy
1. Was the assignment of patients to
treatments randomized?

2. Was the randomization list concealed?

Block randomization with variable

sized block, to avoid unblinding

11 doses of 8 doses amoxicillin

amoxicillin for 3 or placebo for next
days 2 days
3. Was
follow-up of
patients
sufficiently
long and
complete?

Lost to follow
up no more
than 20%
4. Were patients
analyzed in the
groups to which
they were
randomized?
 INTENTION TO TREAT ANALYSIS

a type of analysis of clinical trial data in

which all patients are included in the
analysis based on their original assignment
to intervention or control groups,
regardless of whether patients failed to
fully participate in the trial for any reason,
including whether they actually received
their allocated treatment, dropped out of
the trial, or crossed over to another group.
5. Were patients, clinicians and study
personnel "blind" to treatment?

Double blind (participants and

researcher)
6. Were the groups treated equally, apart
from the experimental treatment?

ANALGETIKA

random

PLASEBO

random
 6. Were the groups treated equally, apart
from the experimental treatment?

11 doses amoxicillin
for 3 days
5 days of
treatment
(control) 8 doses amoxicillin
for next 2 days
Treatment
11 doses amoxicillin
for 3 days
5 days of
treatment
(experimental) 8 doses placebo
for next 2 days
7. Were the
groups
similar at
the start of
the trial

No
substantial
differences in
the baseline
characteristic
II. Are the valid results of this
randomized trial important?

1. What is the magnitude of the treatment

effect?

2. How precise is the estimate of the

treatment effect?
 Control Event Rate (CER)

CER : the proportion of outcome in the control group

(treatment standard or placebo groups)

Experimental Event Rate (EER)

CER : the proportion of outcome in the experimental group

(treatment standard or placebo groups)
EER CER
Relative Risk Reduction (RRR)

RRR = (|CER EER|/CER)

RRR = (89.9-89.5/89.9)

RRR = 0.005
Absolute Risk Reduction (ARR)

ARR = (|CER EER|)

ARR = (89.90-89.50)

ARR = 0.40
Confidence Interval (CI) ARR

CER (1 CER) EER (1 EER)

1.96
Ncontrol Nexp

95% CI = (1.96 x 1.30)

95% CI = 2.26
95% CI ARR

95% CI ARR = 0.40 2.26

95% CI ARR = -1.86 - 2.66

Number Needed to Treat (NNT)

NNT = 1/ARR

NNT = 1/0.4%

NNT = 250
CONCLUSIONS OF THIS EVIDENT

LEVEL : 1B

VALID

EQUALLY EFFECTIVE

APPLY ?
THANKS FOR ATTENTION