AA

1. Tugas MKDU PPDS Januari 2022
Kuliah Search Strategy
Evidence Based Medicine
Disusun oleh
Widya Wira Putri
04032722226010
Sp-1 Ilmu Kesehatan Mata
PEMBIMBING
dr. Achmad Ridwan Mo, MSc
Fakultas Kedokteran Universitas Sriwijaya
Rumah Sakit Mohammad Hoesin Palembang
2022

2. Skenario Individu
Clinical Scenario
A 4-year-old boy came to the hospital complaining of ear pain and a feeling of fullness in the ear. His
mother said that her son often travels by plane with his family and has had a fever since 2 days ago
with a temperature of 38c. On physical examination, there was a discharge from the middle ear. After
the examination, the child was diagnosed with acute otitis media by the doctor. The child has been
treated with the installation of a ventilation pipe in the middle ear which functions to drain fluid in the
middle ear, then the doctor will give antibiotic therapy. Doctors want to compare therapy with topical
antibiotics and oral antibiotics
Question
Is therapy using topical antibiotics more effective than oral antibiotics?
PICO
Synonim
Patients Child 4 years old Ottorea
Intervention Topical Antibiotic
Comparator Oral Antibiotic
Outcome Efficacy Efficacy
Search Strategy (Pubmed)
(Otitis media) AND (topical antibiotic) AND (oral antibiotic)
Website
http://www.ncbi.nlm.nih.gov/pubmed
Result
5 articles
Selected article
A TRIALOF TREATMENTFOR ACUTEOTORRHEA INCHILDRENWITHTYMPANOSTOMY
TUBES

4. Critical Appraisal Therapy Study
(Randomized Controlled Trial
SCREENING
Does the study question match your question?
Was the study design appropriate?
Yes,it does. The study matches with my
question.
Yes,it was.
VALIDITY
F: Patient Follow-Up
 Were all patients who entered the trial
properly accounted for at its conclusion?
Losses to follow-up should be less than 20%
and reasons for drop-out given.
 Was follow-up long enough?
Yes,they were. Losses to follow up less than
20%. The patient adherence rate to this study
was approximately 94% assessed according to
diary entries and follow-up was done with
visits. 17 partisipants did not undergo
randomization because the body temperature
>38,9o
C
Yes, the follow up happened for 6 months.
R: Randomization
 Were the recruited patients representative of
the target population?
 Was the allocation (assignment) of patients
to treatment randomized and concealed?
Yes,they were representative of target
population.
The randomization assignment was concealed
and could not be predicted in advance of or
during enrollment. The assignments were
balanced in a 1:1:1 ratio for the three study
groups: hydrocortisone–bacitracin–colistin ear-
drops (Bacicoline-B, Daleco Pharma) (adminis-
tered as five drops, three times daily, in the
discharging earor earsfor 7 days),oral amoxicil-
lin–clavulanate suspension (30 mg of amoxicillin
and 7.5 mg of clavulanate per kilogram of body
weight per day, divided into three daily doses ad-
ministered orally for 7 days), or initial observa-
tion for 2 weeks (no assigned medication pre-
scription to fill).
I: Intention to Treat Analysis
 Were patients analyzed in the groups
to which they were randomized?
 Were all randomized patient data
analyzed? If not, was a sensitivity or
“worst case scenario” analysis done?
Yes,they were. All the authors vouch for the
completeness and accuracy of the data and
analyses presented and for the fidelity of the
trial to the study protocol.
Yes,they analyzed all of patient’s data.
S: Similar Baseline Characteristics of
Patients
Were groups similar at the start of the
trial?
Yes, they were similar at the startof the trial. The
participants consist of children 1 to 10 years of
age with symptoms of tympanostomy-tube

5. otorrhea that had lasted for up to 7 days at the
time of screening were eligible for trial
participation. The assignments were balanced in
a 1:1:1 ratio for the three study groups
B: Blinding
 Were patients, health workers, and
study personnel “blind” to treatment?
 If blinding was impossible, were blinded
raters and/or objective outcome measures
used?
Yes,they were. the analyses were blinded with
respect to study-group assignment
The blinding was possible
E: Equal Treatment
 Aside from the experimental
intervention, were the groups treated
equally?
Yes,the groups treated equally. From June 2009
through May 2012, ear,nose, and throat
surgeons and family physicians approached
parents of children with tympanostomy tubes
for study participation. Our research team
contacted by telephone parents who expressed
interest in participation.
Conflict of Interest
 Are the sources of support and other
potential conflicts of interest acknowledged
and addressed?
No, are not. No other potential conflict of
interest relevant to this article was reported.
Summary of Article’s Validity
 Notable study strengths or weaknesses
or concerns?
 How serious are the threats to validity
and in what direction could they bias the
study outcomes?
They also calculated the risk difference and 95%
confidence interval for the comparison of oral
antibiotics with initial observation for our
primary outcome, as well as relative risks and
95% confidence intervals for all treatment com-
parisons. Using log-binomial regression
analyses, we adjusted relative risks for possible
confound- ing on the basis of a priori–defined
clinically relevant and statistically significant
differences in baseline characteristics.
At the home visit, the study physician obtained
written informed consent from parents,
confirmed the presence of otorrhea
otoscopically, took otorrhea samples for bacterial
culture, and collected demographic and disease-
specific data.Parentscompleted the Child Health
Question- naire (CHQ), which measures generic
health- related quality of life, and the Otitis
Media–6 (OM-6) questionnaire, which measures
disease specific health-related quality of life.
Scores on the CHQ range from 1 to 35 across the
four CHQdomains, with higher scoresindicating
better quality of life. Scores on the OM-6

6. questionnaire range from 6 to 42, with lower
scores indicating better quality of life.
CLINICAL IMPORTANCE
Out come present Outcome absent
Treated/Exposed a= 71 b= 5 76
Control (Not exposed) c= 68 d= 9 77
CER *Control event rate)=c/(c+d) 0.88 = 88%
EER (experimenal event rate) =a/(a+b) 0.93=93%
RR (Relative Risik)=(a+b)/(c+d) 1.05
RRR (relative Risi reduction)/RBI (relative
Benefit Increase)=(CER-EER)/CER
0.06=6%
ARI (Atributable Riskk Reduction)/ABI
(Absolut Benefit Increase)-CER-EER
0.15= 15%
NNT (Bnmber Needed tto Treat) 1/RRR 20
Results OF IMPORTANCY Penting secara klnis nilia RRR 6% dan penting
secara statistic nilai p atau IK
APPLICAbILITY
`
Similar patient
1. Are your patients similar to those in the
study?
Yes,they are.
2. Are they so different that the results can’t
help you
Apakah tersedia obat, keahllian, fasilitas, biaya
yg diperlukkan?
Yes,it’s available
3. How much of the study effect can you expect
for your patients
Apakah pasin dan keluarga dapat menerima
pemberian obat/pengobatan atas dasar nilai nilai
sosial, budaya dan agama?
Yes,it can be accepted.
Realistic Interventions
4. Is the intervention realistic in your setting? Yes,it was realistic
5. Does the comparison intervention reflect your
current practice?
Yes,it does.
6. What alternatives are available Since acute tympanostomy-tube otorrhea, like
acute otitis media, may be self-limiting, initial
observation may also be a good alternative.8,In
this trial, we compared the effectiveness of three
strategies for the management of acute
tympanostomy-tube otorrhea in children:
immediate treatment with antibiotic–
glucocorticoid eardrops, immediate treatment
with oral anti- biotics, and initial observation
Right Outcomes
7. Have all the right outcomes been considered? The writer have considered all the right
outcomes

7. 8. Are the outcomes appropriate to your patient? Yes,it is appropriate
9. Does the intervention meet their values and
preferences?
Yes,It does
Overall conclusion Antibiotic–glucocorticoid eardrops were more
effective than oral antibiotics and initial
observation in children with tympanostomy
tubes who had uncomplicated acute otorrhea