1. LEMBAR JAWABAN EBM
MKDU PPDS JANUARI 2022
Disusun oleh
dr. Widya Wira Putri
04032722226010
Sp-1 Ilmu Kesehatan Mata
PEMBIMBING
dr. Iche Andriani Liberty, M.Epid
KELOMPOK STAF MEDIK MATA
FAKULTAS KEDOKTERAN UNIVERSITAS SRIWIJAYA
RUMAH SAKIT MOHAMMAD HOESIN PALEMBANG
2022
2. 1. You see a child at age 3 with congenital disabling spatic cerebral palsy (CP). The cause of the
CP remains a mystery, and the anxious parents are seeking your expert opinion. The little girls
was born full-term with normal birth weight and cord blood pH. Her 5-minute Apgar Score
was 5. Her mother had fever during labour but there was no evidence of infection was reported
as a major risk factor for CP in premature infants. You wonder wether this is also true for term
newborn
1.1 Buatlah Tabel P.I.C.O
P (Patient/Problem) Child with cerebral palsy (CP)
I (Intervention) Infection
C (Comparative Intervention) -
O (Outcome) Cerebral Palsy
1.2 Buatlah Clinical Question
In child with cerebral palsy, is maternal infection become a major risk factor for fullterm
newborn?
1.3 Buatlah Search Term/Search Keyword
[Children OR child] AND [maternal infection] AND [cerebral palsy]
1.4 Lakukan Searching
Telah dilakukan pencarian pada database jurnal online www.pubmed.gov menggunakan
search term / search keyword “[Children OR child] AND [maternal infection] AND
[cerebral palsy]”, ditemukan 38 jurnal yang relevan dengan clinical scenario.
3. 1.5 Pastekan Abstract Artikel yang didapat pad alembar jawaban
Jawab:
Abstract
Background and aim: The association between maternal infection during pregnancy and
the risk of cerebral palsy has been previously reported. However, their results were
relatively inconsistent. This systematic review and meta-analysis were carried out to
investigate the association between maternal infection during pregnancy and the risk of
cerebral palsy in children. Methods: PubMed, Scopus, and Web of Sciences databases
were searched from inception to October 28, 2019. Heterogeneity was assessed using the
I2 value. In case of substantial heterogeneity (I2 > 50%), a random effects model was
applied, otherwise, a fixed effects model was used. The pooled associations were expressed
as relative risks (RRs) and 95% confidence intervals (CIs). Publication bias and quality of
studies included in the systematic review were checked using the Egger’s regression test
and Newcastle-Ottawa Scale (NOS), respectively. Results: Thirty-seven studies were
included in the systematic review. Among them, 21 studies were eligible for the meta-
analysis. The pooled RR of cerebral palsy risk was 2.50 (95% CI 1.94, 3.21; I2 ¼ 88.7%,
P < .001) among children born to mothers who had any infection during pregnancy. The
risk was increased to 2.85 (95% CI 1.96, 4.15; I2 ¼ 75.9%, P < .001) when the mother was
diagnosed with chorioamnionitis. Publication bias tests suggested no evidence of potential
publication bias and 76% of the studies included in the meta-analysis were of high quality
(NOS 6). Conclusion: This systematic review and meta-analysis provides evidence that
maternal infection during pregnancy may be associated with an increased risk of cerebral
palsy in children.
1.6 Lakukan Critical Appraisal dari artikel dengan critical appraisal worksheet
Jawab :
PRISMA 2020 CHECKLIST
Citation:
Ayubi, Erfan PhD., Sarhadi, Saeedeh MD., Mansori, Kamyar PhD. Maternal Infection
During Pregnancy and Risk of Cerebral Palsy in Children: A systematic Review and
Meta-analysis. Journal of Child Neurology XX(X):1-18(2020).
https://doi.org/10.1177/0883073820972507
4. Section and
Topic
Item
#
Checklist item
Location
where item
is reported
TITLE
Title 1 Identify the report as a systematic review. 1
ABSTRACT
Abstract 2 See the PRISMA 2020 for Abstracts checklist. 1
INTRODUCTION
Rationale 3 Describe the rationale for the review in the context of existing knowledge. 1-2
Objectives 4 Provide an explicit statementofthe objective(s) or question(s) the review addresses. 2
METHODS
Eligibilitycriteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses. 2
Information
sources
6 Specify all databases,registers,websites,organisations,reference lists and other sources searched or consulted to identify studies.Specifythe
date when each source was lastsearched or consulted.
2
Search strategy 7 Presentthe full search strategies for all databases,registers and websites,including anyfilters and limits used. 2
Selection
process
8 Specify the methods used to decide whether a study metthe inclusion criteria ofthe review, including how manyreviewers screened each record
and each reportretrieved, whether they worked independently,and if applicable,details ofautomation tools used in the process.
2
Data collection
process
9 Specify the methods used to collectdata from reports,including how manyreviewers collected data from each report, whether they worked
independently,any processes for obtaining or confirming data from studyinvestigators,and if applicable,details ofautomation tools used in the
process.
2
Data items 10a Listand define all outcomes for which data were sought.Specify whether all results thatwere compatible with each outcome domain in each
study were sought(e.g. for all measures,time points,analyses),and if not, the methods used to decide which results to col lect.
2
10b Listand define all other variables for which data were sought(e.g. participantand intervention characteristics,funding sources).D escribe any
assumptions made aboutanymissing or unclear information.
2
Study risk of
bias
assessment
11 Specify the methods used to assess risk ofbias in the included studies,including details ofthe tool(s) used,how manyreviewers assessed each
study and whether they worked independently,and if applicable,details ofautomation tools used in the process.
2
Effect measures 12 Specify for each outcome the effect measure(s) (e.g.risk ratio, mean difference) used in the synthesis or presentation ofre sults. 2
Synthesis
methods
13a Describe the processes used to decide which studies were eligible for each synthesis (e.g.tabulating the study intervention characteristics and
comparing againstthe planned groups for each synthesis (item #5)).
2
13b Describe anymethods required to prepare the data for presentation or synthesis,such as handling ofmissing summarystatisti cs,or data
conversions.
2
13c Describe anymethods used to tabulate or visuallydisplayresults ofindividual studies and syntheses. 2
13d Describe anymethods used to synthesize results and provide a rationale for the choice(s).If meta-analysis was performed,describe the
model(s),method(s) to identify the presence and extent of statistical heterogeneity,and software package(s) used.
2
13e Describe anymethods used to explore possible causes ofheterogeneityamong studyresults (e.g.subgroup analysis,meta-regression). 2
5. Section and
Topic
Item
#
Checklist item
Location
where item
is reported
13f Describe anysensitivity analyses conducted to assess robustness ofthe synthesized results. -
Reporting bias
assessment
14 Describe anymethods used to assess risk ofbias due to missing results in a synthesis (arising from reporting biases). 2
Certainty
assessment
15 Describe anymethods used to assess certainty(or confidence) in the body of evidence for an outcome. 2
RESULTS
Study selection 16a Describe the results ofthe search and selection process,from the number of records identified in the search to the number ofstudies included in
the review, ideally using a flow diagram.
2-3
16b Cite studies thatmightappear to meetthe inclusion criteria,butwhich were excluded, and explain why they were excluded. 2-3
Study
characteristics
17 Cite each included studyand presentits characteristics. 3-12
Risk of bias in
studies
18 Presentassessments ofrisk of bias for each included study. 14, Figure 4
Results of
individual
studies
19 For all outcomes, present,for each study: (a) summarystatistics for each group (where appropriate) and (b) an effect estimate and its precisi on
(e.g. confidence/credible interval),ideallyusing structured tables or plots.
13, Figure 2
Results of
syntheses
20a For each synthesis,brieflysummarise the characteristics and risk ofbias among contributing studies. 14-15
20b Presentresults ofall statistical syntheses conducted.Ifmeta-analysis was done,presentfor each the summaryestimate and its precision (e.g.
confidence/credible interval) and measures ofstatistical heterogeneity.If comparing groups,describe the direction ofthe e ffect.
14
20c Presentresults ofall investigations ofpossible causes ofheterogeneityamong studyresults. 14
20d Presentresults ofall sensitivityanalyses conducted to assess the robustness ofthe synthesized results. 14-15
Reporting
biases
21 Presentassessments ofrisk of bias due to missing results (arising from reporting biases) for each synthesis assessed. -
Certainty of
evidence
22 Presentassessments ofcertainty (or confidence) in the body of evidence for each outcome assessed. 13-14
DISCUSSION
Discussion 23a Provide a general interpretation ofthe results in the context of other evidence. 15
23b Discuss anylimitations ofthe evidence included in the review. 16
23c Discuss anylimitations ofthe review processes used. 16
23d Discuss implications ofthe results for practice, policy, and future research. -
OTHER INFORMATION
24a Provide registration information for the review, including register name and registration number,or state that the review wa s not registered. -
6. Section and
Topic
Item
#
Checklist item
Location
where item
is reported
Registration
and protocol
24b Indicate where the review protocol can be accessed,or state that a protocol was not prepared. -
24c Describe and explain any amendments to information provided atregistration or in the protocol. -
Support 25 Describe sources offinancial or non-financial supportfor the review, and the role of the funders or sponsors in the review. 16
Competing
interests
26 Declare any competing interests ofreview authors. 16
Availability of
data, code and
other materials
27 Reportwhich of the following are publiclyavailable and where they can be found: template data collection forms;data extracted from included
studies;data used for all analyses;analytic code;any other materials used in the review.
16
From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ
2021;372:n71. doi: 10.1136/bmj.n71
For more information, visit: http://www.prisma-statement.org/
7. 2 Suatu penelitian RCT yang dilakukan pada penderita Ischemic Stroke dengan memakai
regimen pengobatan baru sebagai experimental group dan standar pengobatan sebagai control
grup. Dari hasil observasi selama 2 tahun didapatkan 10% pada kelompok experimental grup
meninggal, dan 27% pada control group meninggal. Jumlah sampel masing-masing kelompok
adalah 200 penderita ischemic stroke. Hitunglah:
Target Outcome Total
Dead Alive
Regimen Pengobatan Baru 10% (20) (a) 90% (180) (b) 200 (a+b)
Standar Pengobatan 27% (54) (c) 73% (146) (d) 200 (c+d)
Total 74 (a+c) 326 (b+d) 400 (a+b+c+d)
2.6 Experimental Event Rate (EER) (a/(a+b)) = 0.1
2.2 Control Event Rate (CER) (c/(c+d)) = 0.27
2.3 Absolute Risk Reduction (ARR) (c/(c+d) – a/(a+b)) = 0.17
2.4 Relative Risk Reduction (RRR) (1-RR) = 0.63
2.5 Relative Risk (RR) (EER/CER)[a/(a+b)]/[c/(c+d)] = 0.37
2.6 Number Needed to Treat (NNT) 1/ARR = 5.8
2.7 Bagaimana cara alternative untuk menghitung RRR
Jawab :
Cara menghitung RRR
(CER – EER) / CER atau
1- RR
2.8 Buatlah Kesimpulan
EER = 0.1; artinya kejadian kematian dalam penggunaan regimen pengobatan baru
pada penderita Ischemic Stroke dalam studi ini adalah sebesar 10%.
CER = 0.27; artinya kejadian kematian dalam penggunaan pengobatan standar pada
pasien Ischemic Stroke dalam studi ini adalah sebesar 27%
ARR = 0.17; artinya dalam penggunaan regimen pengobatan baru, selisih jumlah
insiden kematian dengan pasien yang menggunakan pengobatan standar adalah sebesar
17%
RRR = 0.63; artinya apabila regimen pengobatan baru digunakan sebagai terapi, maka
insiden kematian pada pasien dapat diturunkan sebesar 63% dari insiden sebelumnya
RR = 0.37; artinya kemungkinan kematian pasien yang menggunakan regimen
pengobatan baru adalah sebanyak 0.37 kali dibandingkan dengan kelompok
pengobatan standar; berarti regimen pengobatan baru lebih dapat mencegah kematian
pasien
NNT = 5.8; artinya dibutuhkan terapi regimen baru sebanyak 5-6 orang untuk
mencegah kematian 1 orang pasien
Kesimpulan :
Secara klinis, hasil penelitian ini penting dan sangat bermakna secara klinis.
8. 3 Suatu penelitian efektivitas pengobatan Myocardium Infark (MCI) dengan experimental group
memakai stent yang dipasang dengan cad, control group memakai ASA+Atorvastatin. Setelah
diobservasi selama 6 bulan, remisi pada experimental group adalah 21% dan remisi pada
control group adalah 15%. Jumlah sampel masing-masing kelompok adalah 200 penderita
MCI. Hitunglah:
Target Outcome Total
Alive Dead
Stent + CAD (Experimental ) 21% (42) 79% (158) 200
ASA + Atorvastatin (Control) 15% (30) 85% (170) 200
Total 72 328 400
3.6 Experimental Event Rate (EER) (a/(a+b)) = 0.21
3.2 Control Event Rate (CER) (c/(c+d)) = 0.15
3.3 Absolute Benefit Increase (ABI) (c/(c+d) – a/(a+b)) = 0.06
3.4 Relative Benefit Increase (RBI) (1-RR) = 0.4
3.5 Relative Risk (RR) (EER/CER)[a/(a+b)]/[c/(c+d)] = 1.4
3.6 Number Needed to Treat (NNT) 1/ARR = 16.67
3.7 Bagaimana cara alternative untuk menghitung RRR
3.8 Buatlah Kesimpulan
EER = 0.21; artinya kejadian kesembuhan dalam penggunaan Stent+CAD pada
penderita Myocardium Infark (MCI) dalam studi ini adalah sebesar 21%
CER = 0.15; artinya kejadian kesembuhan dalam penggunaan ASA + Atorvastatin
pada penderita Myocardium Infark (MCI) dalam studi ini adalah sebesar 15%
ARR = 0.06; artinya dalam penggunaan Stent+CAD, selisih jumlah kesembuhan
dengan pasien yang menggunakan ASA+Atorvastatin adalah sebesar 6%
RRR = 0.4; artinya apabila penggunaan Stent+CAD digunakan sebagai terapi,
maka angka kesembuhan pada pasien akan meningkat sebesar 40% dari insiden
sebelumnya
RR = 1.4; artinya kemungkinan kesembuhan pasien yang menggunakan
Stent+CAD adalah sebanyak 1.4 kali dibandingkan dengan kelompok pengobatan
ASA+Atorvastatin; berarti penggunaan Stent+CAD lebih dapat menyembuhkan
pasien
NNT = 16.67; artinya dibutuhkan terapi penggunaan Stent+CAD sebanyak 16-17
orang untuk menyembuhkan 1 orang pasien
Kesimpulan :
Secara klinis, hasil penelitian ini penting dan bermakna secara klinis.
9. 4 Apa beda NNT pada trial effectiveness dengan NTT pada trial adverse effect?
o NNT trial effectiveness = jumlah sampel yang dibutuhkan untuk menilai efektifitas
suatu experiment. Dapat juga dituliskan dengan “diperlukan sejumlah pasien yang
diberi obat untuk menghindarkan 1 orang yang mendapat outcome baik”.
o NNT trial adverse effect = jumlah sampel yang dibutuhkan untuk menilai efek samping
experiment. Dapat juga dituliskan dengan “diperlukan sejumlah pasien yang
diintervensi untuk menambah 1 orang memperoleh efek samping”.
5 Pada data social ujian dalam bentuk excel terdapat data penelitian penyakit jantung coroner
(PJK/MCI), profil lipid, gula darah dan kreatinin kinase. Lakukan transformasi data dari excel
menjadi data SPSS. Dari data total kolestrol buatlah variable baru dengan nama total
kolestrol13 dengan rumus total kolestrol13 = 0.608 + LDL x 0.939 + Trigliserid x 0.254 +
HDL x 0.928. Selanjutnya data SPSS ditransformasi ke dalam bentuk data Medcalc. Jawablah
pertanyaan di bawah ini dengan menggunakan Software Medcalc dan Epicalc.
Pertanyaan hitunglah:
5.6 Buatlah grafik titik potong total kolestrol13 dalam mendiagnosa PJK dan perkirakan nilai
titik potong tersebut selanjutnya pastekan grafik tersebut dalam lembar jawaban.
Dari grafik di atas secara visual nilai titik potong Total Kolestrol lebih dari 150 mg/dL
dan kurang dari 200 mg/dL adalah cut off point
Classification: Penyakit Jantung Koroner (PJK)
50 100 150 200 250 300 350 400
0
10
20
30
40
50
60
70
80
90
100
Total Kolestrol13
AUC = 0.548
P = 0.167
10. 5.7 Sensitifitas total kolestrol13 dalam mendiagnosa PJK
Jawab :
Sensitifitas Total kolestrol dalam mendiagnosa PJK = 88%,
Perhitungan dengan MedCalc
Perhitungan dengan Catmaker
Total Kolestrol13
0 20 40 60 80 100
0
20
40
60
80
100
100-Specificity
Sensitivity
Sensitivity: 88.2
Specificity: 35.3
Criterion : >154.481
11. Perhitungan dengan EpiCalc
Screening [95% CI]
Prevalence : 0.28 [0.23, 0.34]
Sensitivity : 0.88 [0.79, 0.94]
Specificity : 0.35 [0.29, 0.42]
Accuracy : 0.50 [0.45, 0.56]
Predictive value of +ve result : 0.35 [0.29, 0.42]
Predictive value of -ve result : 0.88 [0.79, 0.94]
Interpretasi :
Sensitivitas 88%, berarti kemampuan Total Kolestrol dalam mendeteksi pasien yang
menderita PJK adalah sebesar 88%
5.8 Spesifisitas total kolestrol13 dalam mendiagnosa PJK
Jawab :
Spesifisitas Total Kolestrol dalam mendiagnosa PJK = 35.3%
Perhitungan dengan MedCalc
Total Kolestrol13
0 20 40 60 80 100
0
20
40
60
80
100
100-Specificity
Sensitivity
Sensitivity: 88.2
Specificity: 35.3
Criterion : >154.481
12. Perhitungan dengan CATMaker
Perhitungan dengan EpiCalc
Screening [95% CI]
Prevalence : 0.28 [0.23, 0.34]
Sensitivity : 0.88 [0.79, 0.94]
Specificity : 0.35 [0.29, 0.42]
Accuracy : 0.50 [0.45, 0.56]
Predictive value of +ve result : 0.35 [0.29, 0.42]
Predictive value of -ve result : 0.88 [0.79, 0.94]
Interpretasi :
Spesifisitas 35% berarti kemampuan Total Kolestrol dalam mendeteksi pasien yang
tidak menderita PJK (tidak sakit) adalah sebesar 35.3%
13. 5.9 Positif Predictive value (PPV)
Jawab :
Positif predictive value = 35%
Perhitungan dengan CATMaker
Perhitungan dengan EpiCalc
Screening [95% CI]
Prevalence : 0.28 [0.23, 0.34]
Sensitivity : 0.88 [0.79, 0.94]
Specificity : 0.35 [0.29, 0.42]
Accuracy : 0.50 [0.45, 0.56]
Predictive value of +ve result : 0.35 [0.29, 0.42]
Predictive value of -ve result : 0.88 [0.79, 0.94]
Interpretasi :
Positive Predictive Value/Nilai Duga Positif 35% berarti probabilitas seseorang dengan
hasil uji diagnostic Total Kolestrol positif (>154.481 mg/dL) menderita PJK adalah
sebesar 35%.
14. 5.10 Negatif Predictive value (NPV)
Jawab :
Negatif Predictive Value = 88%
Perhitungan dengan CATMaker
Perhitungan dengan Epicalc
Screening [95% CI]
Prevalence : 0.28 [0.23, 0.34]
Sensitivity : 0.88 [0.79, 0.94]
Specificity : 0.35 [0.29, 0.42]
Accuracy : 0.50 [0.45, 0.56]
Predictive value of +ve result : 0.35 [0.29, 0.42]
Predictive value of -ve result : 0.88 [0.79, 0.94]
Interpretasi :
Negative Predictive Value/Nilai Duga Negatif 88% berarti probabilitas seseorang
dengan hasil uji diagnostic Total Kolestrol negative (<154.481 mg/dL) tidak menderita
PJK adalah sebesar 88%.
15. 5.11 Likelihood Ratio (+)
Jawab :
Likelihood Ratio (+) [LR+] = 1.36
Perhitungan dengan CATMaker
Interpretasi :
Positive likelihood ratio 1.36%, berarti proporsi subjek yang menderita PJK dengan
Total Kolestrol positif (> 154.481 mg/dL) dengan subjek yang tidak menderita PJK
dengan Total Kolestrol positif (> 154.481 mg/dL) pula adalah 1.36%.
5.12 Likelihood Ratio (-)
Jawab :
Perhitungan dengan CATMaker
16. Interpretasi :
Negatif likelihood ratio 0.33%, berarti proporsi subjek yang menderita PJK dengan
Total Kolestrol negatif (≤ 154.481 mg/dL) dengan subjek yang tidak menderita PJK
dengan Total Kolestrol negatif (≤ 154.481 mg/dL) pula adalah 0.33%.
5.13 LR Test
LR Test = LR (+) / LR (-)
LR Test = 1.36 / 0.33
LR Test = 4.12
5.14 AUC (Keterangan:pastekan data luaran Medcalc pada lembar jawaban anda)
Jawab :
Area Under Curve (AUC) = 0.548
Variable TotalKolestrol13
Total Kolestrol13
Classification variable PJK
Penyakit Jantung Koroner (PJK)
Sample size 300
Positive group : Penyakit Jantung Koroner (PJK) = 1 85
Negative group : Penyakit Jantung Koroner (PJK) = 0 215
Disease prevalence (%) unknown
1.1 Area under the ROC curve (AUC)
Area under the ROC curve (AUC) 0.548
Standard Errora 0.0351
95% Confidence intervalb 0.490 to 0.606
z statistic 1.380
Significance level P (Area=0.5) 0.1675
a DeLong et al., 1988
b Binomial exact