Tugas Individu September 2013

Nama : Fajar Ramadhan Burhan

Stambuk : N 101 12 033

Kelompok : IV ( Empat )

PROGRAM STUDI PENDIDIKAN DOKTER

FAKULTAS KEDOKTERAN DAN ILMU KESEHATAN

UNIVERSITAS TADULAKO

2013

NAMA : FAJAR RAMADHAN BURHAN

STAMBUK : N 101 12 033

KELOMPOK : IV

HARI/TANGGAL :

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 Yes, in Abstract Design Randomised,

treatments randomized? double blind, placebo controlled
multicentre trial.
Was the randomization list concealed? No, Primary and secondary clinical
outcomes In our intention to treat
analysis, clinical cure rates were
89.5%(980/1095) and 89.9%(983/1093)
in the three day treatment and five day
treatment groups, respectively (table 2),
similar among wheezers and non-
wheezers. In the per protocol analysis,
the clinical cure rates were 94.9%
(980/1033) and 95.8% (983/1026).
There was also no difference groups in
the rate of relapse among those
consisered cured on day 5 (table 2).
Was follow-up of patients sufficiently Complete, We also performed
long and complete? perprotocol analysis for participants
with complete follow up and adherence
 to treatment.
Were all patients analyzed in the groups Yes, We compared baseline and other
to which they were randomized? characteristics and therapeutic failures
between the two treatment groups. We
used the X2 test for categorical
variables and Students I test for
continuous variables.
Were patients, clinicians, and study Yes, double blinding.
personnel kept blind to treatment?
Were the groups treated equally, apart No, Cost analysis We analysed costs
from the experimental treatment? 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.
Were the groups similar at the start of Yes similar, Intervention All
the trial apart from the experimental participants received scored dispersible
therapy? 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

Are the valid results of this randomized trial important?

What is the magnitude of the treatment Results Loss to follow up was 5.4%
effect? by day 5, and 6.8% by day 14. There
were no substansial differences in the
baseline characteristics of the treatment
groups (table 1).
How precise is the estimate of the We found that treatment with oral
treatment effect? 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
Comparison of secondary outcome
measures in 2188 children with non-
severe pneumonia randomized to 3 Relative risk Absolute risk Number
days or 5 days of treatment with
amoxicillin: intention to treat
reduction reduction needed to
analysis. Values are numbers (RRR) (ARR) treat (NNT)
(percentage) of patients unless
stated otherwise
CER EER 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% =
) ) = -0,01 (0,01) (0,9%) 111
95% CI