Tugas Individu 16 September 2013

EVIDENCED BASED MEDICINE (EBM)

PRACTICAL SESSION THERAPY WORKSHEET

DISUSUN OLEH :

Nama : Diah Puspitasari

Stambuk : N 101 12 040
Kelompok : Iv (Empat)

PROGRAM STUDI PENDIDIKAN DOKTER

FAKULTAS KEDOKTERAN DAN ILMU KESEHATAN
UNIVERSITAS TADULAKO
PALU
2013
NAMA : DIAH PUSPITASARI

STAMBUK : N 101 12 040

KELOMPOK : IV

HARI/TANGGAL : SENIN, 16 September 2013

TUGAS

FAK. KEDOKTERAN UNTAD

THERAPY WORKSHEET

Citation: Three day versus five day treatment with amoxicillin for non-severe pneumonia in
young children: a multicentre randomized controlled trial
Cite this article as: BMJ, doi:10.1136/bmj.38049.490255.DE (published 30 March 2004)

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

Was the assignment of patients to treatments Yes, in Abstract Design Randomised,

randomized?
Was the randomization list concealed?
Was follow-up of patients sufficiently long and
complete?
Were all patients analyzed in the groups to
which they were randomized?
double blind, placebo controlled
multicentre trial.
Yes. Sample size and ramdomisation:
Blok randomisation, with variable sized
blocks, was done for each participating
site to avoid unblinding. For both
treatment groups, tablets were placed in
serially numbered opaque containing 11
doses of amoxicillin for three days and a
blue envelope containing eight doses of
either amoxicillin or placebo for the next
two days. Doses were provided for in case
a child vomited within 30 minutes of
taking treatment. Page 2
Complete, We also performed perprotocol
analysis for participants with complete
follow up and adherence to treatment.
Yes, Statistical analysis: Clinical data
analysisOur primary analyses were
done on an intention to treat basis. Page 2

Were patients, clinicians, and study personnel Yes, Participants and methods: This
kept blind to treatment?
Were the groups treated equally, apart from the
experimental treatment?
Were the groups similar at the start of the trial
apart from the experimental therapy?
Are the valid results of this randomized trial important?
What is the magnitude of the treatment effect?
double blind, placebo controlled,
randomised trial was conducted in the
outpatient departments of seven referral
hospitals in India. Page 1
No, Cost analysis We analysed costs
from the payers perspective. We
multiplied the units of each resource used
by its average cost to calculate the total
expenditure on that component of
treatment. Univariate analysis was done to
compare direct medical costs in the two
treatment groups. We used Students test
to compare costs.
Yes similar, Intervention All participants
received scored dispersible tablets of
amoxicillin 125mg for the first three days.
Amoxicillin was given thrice daily
dissolved in 5ml of water, and the
effective does per kilogram body weight
varied from 31 to 54 mg/day. For the next
two days participants received either
amoxicillin or placebo
Results Loss to follow up was 5.4% by
day 5, and 6.8% by day 14. There were no
substansial differences in the baseline
characteristics of the treatment groups
(table 1).
Conclusions: We recommend the three
day course of amoxicillin for treating
community acquired non-severe
pneumonia in children, as this is equally as
effective as a five day course but is
cheaper with increased adherence and
possibly decreased emergence of
antimicrobial resistance. Our findings have
local as well as global implications,
because our study has also confirmed

How precise is the estimate of the treatment
effect?
YOUR CALCULATIONS
Second Outcome
a. Cure on day 5 among wheezers
Comparison of secondary
outcome measures in 2188
children with non-severe
pneumonia randomized to 3
days or 5 days of treatment
with amoxicillin: intention
to treat analysis. Values are
numbers (percentage) of
patients unless stated
otherwise
CER EER
findings from a recently published data
from elsewhere, page 5
We found that treatment with oral
amoxicillin for either three days of five
days was equally effective for non-severe
pneumonia. Among children with
complete follow up who adhered to
treatment , cure rate was about 95%. From
the numbers needed to treat, we calculate
that 250 cases of non-severe pneumonia
would need to be treated with five days of
amoxicillin rather than three days for one
additional cure.
Of the 1963 patients assessed ad clinically
cured, mothers or carers reported that 1005
(51.2 %) were completely well, 938
(47.8%) were improved but still sick, 26
(1.3%) were the same, and one (0.1%) was
worse. Of the 96 patients assessed as not
cured, mothers reported that 42% were
completely well, 63.5% were improved
but still sick, 29.2% were the same, and
3.1% were worse (P=0.001)
Number
Relative risk Absolute risk
needed to treat
reduction (RRR) reduction (ARR)
(NNT)
CER-EER/CER CER-EER 1/ARR
132/147(89.8 127/140(90.7 89.8-90.7/89.8 = 89.8-90.7= -0.9
1/0,9% = 111
) ) -0,01 (0,01) (0,9%)
95% CI

b. Cure on day 5 among non-wheezers

Comparison of secondary
outcome measures in 2188
children with non-severe
pneumonia randomized to 3
Number
days or 5 days of treatment Relative risk Absolute risk
needed to treat
with amoxicillin: intention reduction (RRR) reduction (ARR)
(NNT)
to treat analysis. Values are
numbers (percentage) of
patients unless stated
otherwise
CER EER CER-EER/CER CER-EER 1/ARR
851/946(90.0 853/957(89.1 90.0-89.1/90.0 = 90.0-89.1 = 0.9
1/0,9% = 111
) ) 0.01 (0,9%)
95% CI