THERAPY WORKSHEET

THREE DAYS VERSUS FIVE DAY TREATMENT WITH

AMOXICILLIN FOR NON-SEVERE PNEUMONIA IN YOUNG
CHILDREN : A MULTICENTRE RANDOMISED CONTROLLED
TRIAL

NAMA : SHOFA AJI SETYOKO

STAMBUK : N 101 12 051

KELOMPOK : IV

PROGRAM STUDI PENDIDIKAN DOKTER

FAKULTAS KEDOKTERAN DAN ILMU KESEHATAN

UNIVERSITAS TADULAKO

2013
 THERAPY WORKSHEET

PICO ??
P : Pneumonia ringan pada anak-anak
I : Terapi Amoxicillin 3 hari
C : Terapi Amoxicillin 5 hari
O : Tingkat Kesembuhan Pneumonia ringan

Citation : Three day versus five day treatment with amoxicillin for non-severe
pneumonia in young children : a multicentre randomised controlled trial

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

Was the assignment of patients to

treatments randomized?
Was the rendomized list concealed?
Was follow-up of patients sufficiently long
and complete?
Yes, in the tittle : Three day versus five day
treatment with amoxicillin for non-severe
pneumonia in young children, a multicentre
randomised controlled trial.
Yes. 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.
Yes
Were all patients analyzed in the groups
to which they were randomized?
Were patients, clinicans, and study
personnel 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 result of this randomized trial important?
What is the magnitude of the treatment
effect?
How precise is the estimate of the
treatment effect?
Yes, We compared baseline and other
characteristics and therapeutic failures
between the two treatment groups. We used
the X2 test for categorical variables and
Students I test for continuous variables.
Yes (Double blind karena pasien tidak
mengetahui ada yang meminum obat selama
3 hari amoxicillin dan 3 hari amoxicillin
ditambah 2 hari placebo)
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).
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.
YOUR CALCULATIONS

Relative risk Absolute risk Number needed to

reduction (RRR) reduction (ARR) treat (NNT)
CER EER CER-EER CER-EER 1/ARR
CER

89,8% 90,7% 0,9% 1/0,9 = 111

95% Cl

Secondary Outcome :

Cure on day 5 among wheezers

RRR = CER-EER -- = 89,8 90,7 = - 0,01

CER 89,8

ARR = CER EER = 89,8 90,7 = - 0,9

NNT = 1/ARR = 1/-0,9 * 100% = -111

Cure on day 5 among non-wheezers

RRR = CER-EER -- = 90,0 89,1= 0,01

CER 90,0

ARR = CER EER = 90,0 89,1= 0,9

NNT = 1/ARR = 1/0,9 * 100% = 111