Tugas Individu September

2013

Nama : Vera Uliana Simanjuntak

Stambuk : N 101 12 044

Kelompok : IV ( Empat )

PROGRAM STUDI PENDIDIKAN DOKTER

FAKULTAS KEDOKTERAN DAN ILMU KESEHATAN

UNIVERSITAS TADULAKO

2013
Therapy Worksheet

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 randomized
controlled trial. Cite this article as: BMJ,
doi:10.1136/bmj.38049.490255.DE (published 30 March 2004)

Are the result of this single preventive or therapeutic trial trial

valid?

Yes, in the tittle : Three day versus

Was the assignment of patients five day treatment with amoxicillin
to treatments randomized? 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
Was the rendomized list
containing 11 doses of amoxicillin
concealed?
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.
Was follow-up of patients Yes
sufficiently long and complete?

Were all patients analyzed in

the groups to which they were Yes (Statistical analysis )
randomized?
Yes (Double blind karena pasien
Were patients, clinicans, and tidak mengetahui ada yang
study personnel kept blind to meminum obat selama 3 hari
treatment? amoxicillin dan 3 hari amoxicillin
ditambah 2 hari placebo)
Were the groups treated
equally, apart from the Yes ( In the table 1 )
experimental treatment?
Were the groups similar at the
start of the trial apart from the Yes ( In the table1)
experimental therapy?

Melakukan perhitungan RRR, ARR dan NNT pada tabel 2.

3 day 5 day Difference (95

treatment treatment % CI)
(n=1095) (1093)
Primary
Outcome
Measures:
Cure on day 5 980 (89,5) 983 (89,9) 0,4 ( -2,1 to 3,0)
Relapse after 58 (5,3) 48 (4,4) 1,0 ( -0,1 to 3,0)
day 5
Secondary
Outcome
Measures:
Cure on day 5 127/140 (90,7) 132/147 (89,8) 0,9 ( -5,9 to 7,8)
 among
wheezers
Cure on day 5 853/957 (89,1) 851/946 (90,0) 0,7 ( -2,1 to 3,4)
among non
wheezers

Diketahui :

Amoxicilin 5 day treatment : Control Event Rate (CER)

Amoxicilin 3 day treatment : Experimental Event Rate (EER)

YOUR CALCULATIONS

Primary Outcome

Cure No Day 5

Relative risk reduction Absolute risk Number needed to

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

89,9 89,5 89,9 89,5 =

89,9% 89,5 % =0,004 4 1/0,4% = 250
89,5 0,4%

95% Cl

Relapse After 5 Day

Relative risk reduction Absolute risk Number needed to

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

4,4 - 5,3 = 0,20

4,4 % 5,3 % 4,4 - 5,3 = - 0,9 1/0,9% = 111
4,4
 95% Cl

Secondary Outcome

Cure no day 5 among wheezers

Absolute risk Number

Relative risk
reduction needed to
reduction (RRR)
(ARR) treat (NNT)
CER-EER
CER EER CER-EER 1/ARR
CER

89,8% 90,7% 89,890,7 89,890,7 = 1/0,9 = 111

=0,01
89,8
0,9%

95% Cl

Cure no day 5 among wheezers

Absolute risk Number

Relative risk
reduction needed to
reduction (RRR)
(ARR) treat (NNT)
CER-EER
CER EER CER-EER 1/ARR
CER
90,089,1 90,089,1 =
=0,01
90,0 % 89,1% 90,0 1/0,9 = 111
0,9%

95% Cl

Penyelesaian:

Primary Outcome:

Cure on day 5

RRR = CER-EER = 89,9 89,5 = 0,0044

CER 89,5

ARR = CER EER = 89,9 89,5= 0,4

 NNT = 1/ARR = 1/0,4 x 100% = 250

Relapse after day 5

RRR = CER-EER = 4,4 - 5,3 = 0,20

CER 4,4

ARR = CER EER = 4,4 - 5,3 = - 0,9

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

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 x 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 x 100% = 111

Table 1

Baseline characteristics of 2188 children with non-severe pneumonia

randomised to 3 days or 5 days of treatment with amoxicillin. Values are
numbers (percentages) of patients unless stated otherwise

Characteristic 3 day treatment 5 day treatment

(n=1095) (n=1093)
Mean (SD) age (months) 17.0 (13.3) 16.9 (13.0)
Mean (SD) height (cm) 74.8 (10.98) 74.8 (10.75)
Mean (SD) weight (kg) 8.7 (2.49) 8.7 (2.4)
Mean (SD) duration of illness 4.7 (3.43) 4.5 (3.12)
(days)
Mean (SD) temperature (C) 37.1 (0.66) 37.2 (0.67)
 Mean (SD) respiratory rate
(breaths/minute):
2-11 months old 56.4 (5.02) 56.0 (4.54)
12-59 months old 47.3 (5.58) 47.9 (6.1)
Male 685 (62.6) 676 (61.8)
Age (months):
2-11 479 (43.7) 475 (43.5)
12-59 616 (56.3) 618 (56.5)
Weight for height z score*:
2 to 1 300 (27.4) 303 (27.7)
3 to 2 188 (17.2) 183 (16.7)
Duration of illness (days):
<3 538 (49.1) 540 (49.4)
3 557 (50.9) 553 (50.6)
Fever 833 (76.1) 850 (77.8)
Cough 1081 (98.7) 1078 (98.6)
Difficulty in breathing 417 (38.1) 387 (35.4)
Vomiting 135 (12.3) 141 (12.9)
Diarrhoea 71 (6.5) 55 (5.0)
Excess respiratory rate
(breaths/minute):
10 903 (82.5) 881 (80.6)
>10 192 (17.5) 212 (19.4)
Wheeze present 140 (12.8) 147 (13.4)
Adherence to treatment:
At day 3 1031 (94.2) 1026 (93.9)
At day 5 937 (85.6) 928 (84.9)
RSV positive 252 (23.0) 261 (23.9)

RSV = Respiratory Syncytial Virus.

Z score given as number of standard deviations from normal value.

Rate above the age specific cut off.