PELATIHAN CALON PEMBIMBING LAPANGAN

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P E N DA L A M A N K E T RA M P I L A N
KLINIS

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FAKULTAS KEDOKTERAN UNIVERSITAS GADJAH MADA

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 PELATIHAN CALON PEMBIMBING LAPANGAN
DOKTER LAYANAN PRIMER
MASA TRANSISI

LOGBOOK
STASE RUAMH SAKIT

Pendalaman Ketrampilan Klinis

Faculty of Medicine, Universitas Gadjah Mada, April 2016 Printed in Yogyakarta

Published by Faculty of Medicine,
Universitas Gadjah Mada
All Rights reserved

This publication is protected by Copyright law and permission should be obtained from
publisher prior to any prohibited reproduction, storage a retrieval system, or
transmission in any form by any means, electronic, mechanical, photocopying, and
recording or likewise.
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 PENDALAMAN KETERAMPILAN KLINIS

Ketua
Prof. dr. Hari Kusnanto Josep, MPH, Dr.PH
Sekretaris
Dr. Med. dr. Indwiyani Astuti

Departemen Kedokteran Keluarga, Komunitas, dan Bioetika

Prof. Dr. dr. Adi Heru Sutomo, MSc, DCN, DLSHTM
Prof. dr. Hari Kusnanto Josep, MPH, Dr.PH
Dr. dr. Wahyudi Istiono, M.Kes
dr. Mora Claramita, MHPE, PhD
dr. Hikmawati Nurrokhmanti, MSc
dr. Fitriana Murriya Ekawati, MPHC
dr. Aghnaa Gayatri, MSc
dr. Fitriana, MSc.FM
dr. Riadiani Nindya Drupadi

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 Evidence Based Medicine
Form Critical Appraisal
Diagnosis Study

Are the results of this diagnostic study valid?

Was there an independent, blind comparison with a reference (gold) standard of

diagnosis?
This paper : Yes No Unclear
Comment :

Was the diagnostic test evaluated in an appropiate spectrum of patients (like those
in whom it would be used in practice)?
This paper : Yes No Unclear
Comment :

Was the reference standard applied regardless of the diagnostic test result?
This paper : Yes No Unclear
Comment :

Was the test (or cluster of tests) validated in a second, independent group of
patients?
This paper : Yes No Unclear
Comment :

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Kesimpulan :

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 Evidence Based Medicine
Form Critical Appraisal
Therapy Study
Searching flow
Source : Arch Gen Psychiatry. 2005;62:1022-1030
Access date : 01/09/2017
Keyword :-
Address : http://jamanetwork.com/
Are the results of the trial valid? (internal validity)

What question did the study ask?

Patients : Patients with generalized anxiety disorder.
Intervention : Pregabalin

Comparison : Treatment with pregabalin, 300 mg/d (n=91), 450 mg/d (n=90), or 600 mg/d (n=89);
alprazolam, 1.5 mg/d (n=93); or placebo (n=91).

Outcome(s) : To assess the anxiolytic efficacy of pregabalin in patients with generalized anxiety
disorder.

1a. R- Was the assignment of patients to treatments randomised?

This paper : Yes No Unclear

Comment :
Patients were randomized to 4 weeks of treatment.

1b. R- Were the groups similar at the start of the trial?

This paper : Yes No Unclear

Comment :
Male or female outpatients who were 18 years or older, met the DSM-IV24 criteria for GAD based
on a structured Mini-International Neuropsychiatric Interview, and had screening and baseline
scores of 20 or greater on the Hamilton Anxiety Rating Scale (HAM-A) and 9 or greater on the
Covi Anxiety Scale were eligible for enrollment. Change from baseline to end point in total HAM-A
score in the pregabalin and alprazolam groups compared with the placebo group.

2a. A Aside from the allocated treatment, were groups treated equally?
This paper : Yes No Unclear

Comment :
Patients who met the study enrollment criteria completed a 1-week drug-free screening period,
during which no placebo was administered and prohibited medications were washed out; then,
patients were randomized, in blocks of 10, to 4 weeks of double-blind study treatment. At the
conclusion of the 4-week double-blind treatment period, medication was discontinued during a 1-
week taper period, followed by a 1-week medication-free period, during which patients were
examined for the occurrence of discontinuation symptoms. The study was conducted at 29 US
centers based on Good Clinical Practices guidelines and in accordance with the Declaration of
Helsinki. The protocol was approved at each center by the appropriate institutional review board.

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2b. A Were all patients who entered the trial accounted for? and were they
analysed in the groups to which they were randomised?
This paper : Yes No Unclear

Comment :
This was a double-blind placebo-controlled comparison of the efficacy and tolerability of 3 fixed
dosages of pregabalin (300, 450, and 600 mg/d) vs alprazolam (1.5 mg/d) in the treatment of
GAD. All statistical analyses were performed using SAS statistical software, version 6.12,35 for
the intent-to-treat (ITT) population, composed of all randomized patients who received at least 1
dose of study medication.

3. M - Were measures objective or were the patients and clinicians kept blind to
which treatment was being received?

This paper : Yes No Unclear

Comment :
Least squares means and 95% confidence intervals were calculated, and an adjustment for
multiple comparisons was used to test the treatment effect in each pregabalin treatment group vs
the placebo group. For a given efficacy parameter, patients with no postrandomization data were
not included in its analyses (the n values in their tables and figures reflect the number of patients
with data for that parameter). Design with Double-blind, placebo-controlled, activecomparator
trial.

4. Kesimpulan
This journal is valid.

What were the result?

1. How large was the treatment effect?

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(tabel 2 x 2)

Present (case) Absent (control) Total

Intervensi (a) (b)
Placebo (c) (d)
Total

Experimental Event Rate (EER) :

a
EER= =
a+b

Hal ini berarti dalam kelompok yang diberikan intervensi berupa ...................................,
sebesar ......... % dari seluruh partisipan mengalami .................................... .
Control Event Rate (CER) :

c
CER= =
c+ d

Hal ini berarti dalam kelompok yang diberikan intervensi berupa placebo, sebesar ... %
dari seluruh partisipan mengalami .......................
Dari kedua perhitungan di atas, dapat dilihat kalau EER >/< CER, hal ini berarti terapi
yang diberikan ................. akan ......................., beberapa perhitungannya nantinya akan
menjadi Absolute Risk Reduction (ARR), Relative Risk Reduction (RRR), dan Number
Needed to Treat (NNT).

What is the measure? What does it mean?

Relative Risk (RR) :
Dari hasil perhitungan, ditemukan bahwa RR
>/< 1, hal ini berarti terapi yang diberikan
EER ................ akan ......................
RR= =
CER

Dari hasil perhitungan, ditemukan bahwa ARR =

Absolute Risk Reduction (ARR)
ARR =|CEREER|=
.... . Hal ini menunjukkan bahwa terapi yang
diberikan ............. tidak/memberikan pengaruh
terhadap ......................, namun hal ini
tidak/cukup signifikan, mengingat nilai ARR
yang negatif/positif.

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Relative Risk Reduction (RRR)

Dari hasil perhitungan, ditemukan bahwa RRR =

ARR .... . Hal ini menunjukkan bahwa terapi yang
RRR= =
CER diberikan.............. tidak/berpengaruh terhdap
..........................

Number Needed to Treat (NNT)

Dari hasil perhitungan, ditemukan bahwa NNT =
... . Hal ini menunjukkan bahwa tidak/dibutuhkan
1 partisipan yang diterapi dengan ..... .
NNT = =
ARR

2. How precise was the estimate of the treatment effect?

95% Confident Interval (CI)

95 CI = 1,96
CER ( 1CER ) EER ( 1EER )
n control
+
n treatment

1. Kesimpulan

Will the results help me in caring for my patient? (external validity/applicability)

Yes. The study results were :

Pregabalin and alprazolam produced a significantly greater reduction in meanSE HAM-A total
score at last-observation-carried-forward end point compared with placebo (8.40.8):
pregabalin, 300mg(12.20.8, P_.001), 450 mg (11.00.8, P=.02), and 600 mg
(11.80.8,P=.002), and alprazolam (10.90.8,P=.02).
By week 1 and at last-observation-carried-forward endpoint, the 3 pregabalin groups and the
alprazolam group had significantly (P<.01) improved HAM-A psychic anxiety symptoms
compared with the placebo group. Compared with the placebo group, HAM-Asomatic anxiety
symptoms were also significantly (P<.02) improved by the 300- and 60- mg pregabalin groups,
but not by the 450-mg pregabalin (week1,P=.06;week4,P=.32) and the alprazolam groups
(week1,P=.21;week4,P=.15). Of the 5 treatment groups, the 300-mg pregabalin group was the
only medication group that differed statistically in global improvement at treatment end point
not only from the placebo group but also from the alprazolam group.

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NO : 05/ADOLESENCE HEALTH/DLP HOLIKOMPRE/JACOB ALIUDIN/2016

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 Evidence Based Medicine
Form Critical Appraisal
Harm Study
Searching flow
Source :
Access date :
Keyword :
Address :
Are the results of the trial valid? (internal validity)
What question did the study ask?
Are the results of this harm study valid?

Were there clearly defined groups of patients, similar in all important ways other than
exposure to the treatment or other cause?
This paper : Yes No Unclear
Comment :

Who were the cases and control :

What is definition of the exposure :

Is the subjects characteristics similar between cases and control :

Were treatments/exposure and clinical outcomes measured in the same ways in both groups
(was the assessment of outcomes either objective or blinded to exposure)?
This paper : Yes No Unclear
Comment :
What is definition of the exposure and outcome :

How the exposure and outcome were determined :

Was the follow-up of study patients sufficiently long and complete?

This paper : Yes No Unclear
Comment :

Do the results satisfy some diagnostic tests for causation?

This paper : Yes No Unclear
Comment :
Is it clear that the exposure preceded the onset of the outcome :

Is there dose-response gradient :

Is there positive evidence from a dechallenge-rechallenge study :

Is the association consistent from study to study :

Does the association make biological sense :

Are the valid results from this harm study important?

What is the magnitude of the association between the exposure and outcome?
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 Adverse outcome
Totals
Present (case) Absent (control)
Exposed to the (a) (b) (a+b)
treatment (c) (d) (c+d)
Totals (a+c) (b+d) (a+b+c+d)

Realtive Risk (RR) What does it mean?

a Dalam studi ini didapatkan RR > 1 maka
exposure yang diberikan (rosiglitazone) akan
RR a b meningkatkan risiko kematian ataupun dibawa
c ke rumah sakit karena gagal jantung atau infark
cd miokard. Kemungkinan partisipan yang
mendapatkan exposure (rosiglitazone) akan
mendapatkan risiko 1.25 kali lebih tinggi
daripada yang tidak diberi exposure (tetapi
diberi pioglitazole).

Odds Ratio (OR) What does it mean?

ad Odds Ratio merupakan data yang dilaporkan
OR dalam studi retrospective yang menunjukkan
bc
risiko dari suatu intervensi saat hasil yang
terlihat pada kelompok case daripada kelompok
Atau memakai calculator pada web : control.
http://www.hutchon.net/ConfidOR.htm Apabila OR <1 maka exposure yang diberikan
memberi efek protektif.
Apabila OR = 1 maka exposure yang diberikan
tidak memberikan perbedaan.
Apabila OR > 1 maka exposure yang diberikan
memberikan efek yang membahayakan (harm).
Number Needed to Harm (NNH) What does it mean?
NNH untuk RCT dan Cohort = Number needed to harm merupakan besarnya
1 partisipan yang diperlukan untuk memberikan
NNH satu efek bahaya akibat exposure yang
a c
diberikan. Semakin tinggi NNH semakin tidak
ab cd berbahaya exposure tersebut. Dan sebaliknya,
semakin sedikit NNH semakin berbahay
exposure yang diberikan tersebut.
Jika case-control study, rumus NNH adalah sebagai
berikut :

1 CER 1 OR
NNH
OR 1 1 CER CER 1 OR
maka

1 CER OR 1
NNH
OR 1 1 CER CER OR 1
maka

Selain rumus di atas, kita bisa mendapatkan NNH

dengan menghitung CER ataupun PEER (patients
expected event rate) terlebih dahulu.

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 c
PEER
cd

Setelah mendapatkan angka PEER, gunakan

calculator dari :
http://ktclearinghouse.ca/cebm/practise/ca/calc
ulators/ortonnt

What is the precision of the estimate of the association between exposure and outcome?

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 Form Kajian Rumah Sakit
Nama pasien dan masalah kesehatan
Nama Dokter dan Dokter Spesialis yang merawat

I. Self Assessment:
a) Ceritakan masalah pasien SEBELUM tiba di Rumah Sakit dan alasan
rujukan:
Format bebas, ditulis rangkuman mengenai data diri pasien, rangkuman hasil
penggalian riwayat penyakit, riwayat keluarga, rangkuman hasil pemeriksaan dan
laboratorium dan penekanan pada masalah yang memerlukan rujukan ke Rumah
Sakit (atau sebenarnya tidak memerlukan rujukan). Bagaimana pendapat anda
sebagai DLP dalam hal rujukan ini.

Bahan kajian: Diagnosis Holistik dan Komprehensif (Person centered care, specific
problem solving, bio psychosocial-cultural background)

b) Ceritakan masalah pasien PADA SAAT dirawat di Rumah Sakit :

Format bebas, ditulis rangkuman mengenai hasil pemeriksaan dan laboratorium

selama di rumah sakit dan penekanan pada masalah (medis maupun psikososial)
yang pasien temui selama perawatan di rumah sakit (bisa rawat inap maupun
rawat jalan di RS). Bagaimana pendapat anda sebagai DLP dalam hal perawatan
RS ini.

Bahan Kajian:
a. Pelayanan Berpusat pada Pasien dan mengutamakan Keselamatan Pasien
(Patient-centered care, Patient Safety)
b. Kerjasama Tim dalam pengelolaan pasien untuk memberikan pelayanan
yang berkualitas (Interprofessional Collaboration to serve the Highest
Quality of Care)

c) Ceritakan rencana pengelolaan pasien SETELAH pulang dari Rumah Sakit

dan kembali di komunitasnya, di mana anda adalah Dokter Keluarga/
Dokter Layanan Primernya di FKTP tempat ia dan keluarganya terdaftar

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 Format bebas, ditulis rangkuman mengenai rencana tindak lanjut ketika pasien
dipulangkan. Penekanan pada persiapan kepulangan pasien, penerimaan keluarga
di rumah, rencana medis dan psikososial apa yang diperlukan ketika pasien
pulang. Bagaimana rencana kontrol ulang di Rumah Sakit, apa yang harus anda
diskusikan dengan Dokter Spesialis yang merawat di RS maupun kepada Perawat
atau Bidan atau Tenaga Kesehatan lain yang akan merawatnya saat kembali ke
FKTP. Bagaimana rencana anda sebagai DLP dalam hal kepulangan dari RS ini.

Bahan Kajian:
a. Kerjasama Tim dalam pengelolaan pasien untuk memberikan pelayanan
yang berkualitas (Interprofessional Collaboration to serve the Highest
Quality of Care)
b. Koordinasi dengan Nakes di Sekunder/ Tersier maupun di Primer
(Comprehensive care)

II. Rencana pengelolaan lanjutan atas masalah

kesehatan pasien di atas:

Setelah pasien pulang dari RS dan bermaksud kontrol kepada anda di FKTP, apa
rencana pengelolaan pasien Jangka Pendek (3 bulan pertama) dan Jangka Panjang
(lebih atau sama dengan 1 tahun) yang akan anda komunikasikan kepada pasien.
Perlukah anda lakukan Home Visit, apa alasannya.

Bahan Kajian: Pelayanan Berkelanjutan (Continuity of Care)

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Referensi yang saya baca dan telah saya lakukan telaah kritis
(terlampir):

1.

2.

3.
..
4.
..
5.

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