PENAPISAN TEKNOLOGI

DIAGNOSTIK

Bambang Udji Djoko Rianto

 The technology assesment
iterative loop
Burden of illness

Efficacy
Monitoring &
reassessment
Screening & diagnosis
Synthesis &
implementation Community Effectiveness

Efficiency
TUJUAN

 Memahami berbagai masalah terkait dg

penggunaan teknologi diagnostik bidang
kedokteran/kesehatan
 Melakukan penilaian kritis thd penggunaan
suatu teknologi diagnostik
PENDAHULUAN

 Ketepatan diagnosis: kunci sukses

penanganan pasien
 Pengembangan teknologi diagnostik
membawa manfaat dan dampak
Pendahuluan
TEKNOLOGI DIAGNOSTIK

Disease/non disease

Accurate Safe Therapeutic impact

Jumlah & rerata CT-scanner/1 juta
penduduk
Jumlah CT CT scanner/juta
Negara Scanner penduduk
1986 1988 1986 1988
AS 3000 4991 12.8 21.7
Jepang 3300 5448 27.5 44.3
Perancis 264 350 4.7 6.3
Belgia 64 118 6.4 12.1
Jerman Barat 423 595 6.9 9.8
Denmark 23 ? 4.6 ?
Belanda 45 83 3.2 5.7
Inggris 149 204 2.7 3.6
Itali 210 338 3.5 5.9
Jumlah & rerata MRI/ 1 juta penduduk

Negara Jumlah MRI Rerata MRI/juta

penduduk
1986 1988 1986 1988
AS 110 1150 0.5 5.0
Jepang 10 256 0.1 2.0
Perancis 29 34 0.5 0.6
Belgia 7 7 0.7 0.7
Jerman Barat 41 91 0.7 1.5
Belanda 2 7 0.4 0.5
Inggris 14 28 0.3 0.5
Itali 13 29 0.2 0.5
 Test-treatment thresholds

Do not Do not
test
Test, & treat on test
the basis of the
test’s results
Do not Get on with
treat treatment

0 .10 .20 .30 .40 .50 .60 .70 .80 .90

A B
Prevalence (pre-test probability) of target disoreder
Penilaian teknologi diagnostik

 Tingkat akurasi
 Tingkat ketelitian
 Peruntukan teknologi diagnostik
 Evaluasi teknis
 Peranan dalam proses pengambilan keputusan
terapetik
 Peranan dalam penurunan morbiditas dan
mortalitas
 Keuntungan bagi klinisi
 Keuntungan bagi pasien
 Diagnostic accuracy
 Sensitivitas
 Spesifisitas
 Likelihood ratio
 Penyakit
+ -

True False
T +
positive positive
e
s
t False True
-
negative negative
DEFINISI

 Sensitivity: proporsi hasil test positif pada

kelompok penderita
 Specificity: proporsi hasil test negatif pada
kelompok orang tanpa penyakit
 Positive PV: probabilitas penyakit pada
penderita dengan hasil test positif
 Negative PV: probabilitas seseorang dengan
hasil test negatif untuk benar-benar bebas dari
penyakit
 Gold Standard
+ -

+ a b a+b
Hasil
test
- c d c+d

a+c b+d N

Sensitivity = a / (a+c) + PV = a / (a+b)

Specificity = d / (b+d) - PV = d/ (c+d)
Accuracy = (a+d) / N Prevalence = (a+c) / N
 2 Pendekatan ttg penampilan
diagnosis

Prevalensi Sensitivitas/
Nilai ramal
Spesifisitas

Pre-test Rasio Post-test

probability kemungkinan probability
 Likelihood Ratio
 Likelihood ratio positif: rasio hasil tes
positip yang dijumpai pada kelompok sakit
dan kelompok tidak sakit
 Likelihood ratio negatif: rasio hasil tes
negatip yang dijumpai pada kelompok sakit
dan kelompok tidak sakit
 Gold Standard
+ -

+ a b a+b
Hasil
test
- c d c+d

a+c b+d N
a/a+c c/a+c
LR (+) = -------- LR (-) = --------
b/b+d d/b+d
Lieklihood ratio

 >10 atau < 0,1, menghasilkan perubahan yg

besar dari pre dan post test probability. Dan
sering conclusive
 5-10 dan 0,1-0,2, perubahan sedang
 2-5 daan 0,2-0,5 perubahan kecil (kadang-
kadang penting)
 1-2 dan 0,5-1, mengubah probability kecil
sekali (dan jarang penting)
Ketelitian diagnosis

 Skala nominal: un-weighted kappa

 Skala ordinal: weighted kappa
 Skala interval/rasio: intra-class coefficient
correlation (ICC), CV
Peruntukan teknologi diagnostik

 Menegakkan diagnosis
 Menyingkirkan diagnosis
 Skrining
 Technical evaluation
 Prosedur sederhana
 Risiko minimal
 Interpretasi jelas (risiko false positive rendah)
 Risiko kesalahan pembacaan akibat kesalahan
prosedur operasional kecil
 Ketergantungan terhadap rekonfirmasi diagnosis
atau second opinion kecil
 Diagnostic impact
 Mendeteksi penyakit pada fase dini
 Rekonfirmasi terhadap prosedur diagnostik
sebelumnya
 Hasil mempengaruhi prognosis
 Mengurangi risiko keraguan
 Therapeutic impact

 Mensupport therapeutic decision making

process
 Early treatment
 Mengubah kebijakan terapi yang sudah
diputuskan
 Health impact

 Early warning system

 Morbiditas & mortalitas turun
 Quality of health care
 Reassurance
Seberapa besar kontribusinya
terhadap therapeutic decision
making process

Prompt action Membantu menetapkan

terapi yang lebih do
more good than harm

Keuntungan yang diperoleh

melebihi cost yang dikeluarkan
 Seberapa besar kontribusinya
terhadap penurunan mortalitas dan
morbiditas

Early diagnosis

morbiditas
Prompt treatment
mortalitas
 Apa keuntungannya bagi
klinisi
 Menghilangkan keraguan diagnosis
 Improving confidence
 Lebih terfokus pada pilihan terapi
 Mengurangi risiko malpractice
 Improving quality of care
 Apa keuntungannya bagi
pasien

Opportunity cost
Morbidity/mortality

Disability
Quality of life
Patient satisfaction
Should general practitioner perform diagnostic tests
on patients before prescribing antibiotics?,
BMJ 318, 799-802
 Kendali resistensi thd antibiotik tergantung
perilaku peresepan yg rassional oleh dokter
umum.
 Pemeriksaan mikrobiologis merupakan dasar
pemberian antibiotik yg rasional. Tetapi hal ini
memiliki kendala
 Salah satu cara untuk mengatasi masalah ini di
Denmark melakukan pemeriksaan mikrobiologis
menggunakan mikroskop fase kontras dan kit
diagnostik sederhana (near patient testing)
Keuntungan near patient testing

 Hasil pemeriksaan lebih cepat tersedia

dan keputusan dapat segeraa diambil
 Birokrasi dikurangi. Menghemat waktu,
mengurangi problem komunikasi,
menghemat uang, lebih murah dan
mendapat tambahan pendapatan.
Isu tentang mutu

 Baku pemeriksaan ditempat praktek harus

seimbang dg yg di laboratorium
 Syarat pemeriksaan: sederhana, cepat, handal,
mudah dibaca dan diinterpretasikan
 Contoh: pemeriksaan mikroskopis fase kontras
untuk ISK, vaginitis/vaginosis, pharyngotonsilitis,
dermatophytosis, perianal pruritus,
mononukleosis
 Kepentingan near patient tests

 Paling penting dilakukan untuk discharge

vagina, dysuria, pharyngitis.
 Pemeriksaan mikroskopis fase kontras di tempat
praktek umum lebih teliti dibanding di
laboratorium
 Berfungsi sbg skrining pemeriksaan berikutnya,
misalnya biakan, pemeriksaan Chlamydia,
athropic vaginitis
Aspek uji diagnosis dalam praktek
dokter umum
 Apakah uji/pemeriksaan layak dan valid?
Perlu selektif, pelatihan dan kendali mutu.
Grup A streptococcus vs ASTO. Test strip vs
metode skoring klinis.
 Apakah uji/pemeriksaan mempercepat
kesembuhan? Penurunan keluhan vs
kekambuhan; 50% bakteriuria akan sembuh
dlm waktu 3 hari tanpa antibiotik
Aspek-aspek uji diagnosis dalam
praktek dokter umum

 Apakah uji/pemeriksaan mencegah

komplikasi?
 Apakah pasien diuntungkan?
 Apakah uji/pemeriksaan cost-effective?
 Kesimpulan

 Pemeriksaan diagnosis untuk infeksi akut

dilakukan jika ada bukti yg kuat ttg validitas,
kelayakan, dan cost-effectivenes
 Sebelum ada bukti yg kuat dokter umum
dianjurkaan untuk memberikan obat
simtomatis untuk infeksi yg paling sering
dijumpai tanpa tergantung pd pemeriksaan
diagnosis maupun antibiotik
The impact of medical imaging on
physician’s diagnostic and therapeutic
thinking
Eur. Radiol. 8: 488-90
Pendahuluan

 Ada perubahan kecenderungan bahwa

pemeriksaan radiologi “requested” dari pada
“ordered”
 Permintaan pemeriksaan sering didiskusikan
dalam pertemuan antara dokter klinis dan
radiolog dengan memperhatikan kondisi klinis
pasien, penampilan diagnosis dari bbrp
pilihan, biaya, ketersediaan, daan expertise.
5 tahap dalam penilaian teknologi
radiologi

1. Technical performance
2. Diagnostic performance
3. Diagnostic impact – keputusan
diagnostik
4. Diagnostic impact – keputusan terapi
5. Impact on health
Diagnostic thinking

 Dulu diagnosis pd pasien rawat jalan dpt

ditegakkan dg anamnesis yg baik dan
pemeriksaan fisik
 Modern radiologi mungkin dpt mengubah
fenomena ini
 Radiolog dpt bekerja sama dg klinisi dlm
penatalaksanaan pasien
Diagnostic thinking

 Diagnosis klinis: peran radiologi kurang

tampak apabila klinisi memberikan diagnosis
klinis terlalu luas, begitu juga sebaliknya
 Diagnostic confidence, ditetapkaan dg bbrp
cara: pre-test probability, hasil V/Q scan, 10
point scale, VAS, LR, diagnostic entropy
Diagnostic thinking

 Displacement of other investigations:

pemeriksaan alat lama dan alat baru, alat
baru dpt menggantikan alat lama, misalnya
MRI pada meatus auditorius interna
menggantikan pemeriksaan neurofisiologis
 Health economists and statisticians
Therapeutic thinking

 Pilihan terapi tersedia setelah diagnosis

ditegakkan. Pilihan ini juga tergantung dari
kwalifikasi pengirim
 Pengembangan algoritme
How Often Should We Screen for
Cervical Cancer?
AU: Sarah Feldman, M.D., M.P.H.
SO: New Eng J of Med, Volume 349, Number 16; October 16, 2003

 Over the past 60 years, the mortality from cervical

cancer has decreased dramatically. Much of the
reduction has been due to the widespread use of
the Papanicolaou test, which has enabled clinicians
to detect cervical intraepithelial neoplasia before it
progresses to cervical cancer and to detect cervical
cancer at an early stage.
 When cervical cancer is detected early, the five-year
survival rate is more than 90 %
PAP Smear test

 > 80 % of women undergoing screening in any two-

year period and > 90 % having been screened at
least once.
 Questions remain about optimal screening
strategies. One key question is the optimal
frequency of testing.
 Cost–benefit analyses have suggested that lifelong
annual screening may not result in substantially
better outcomes than less frequent screening and is
much more costly. With this in mind, the American
Cancer Society recently revised its guidelines for
screening
PAP Smear test

 Recommending intervals between screenings

ranging from one to three years, depending on
several factors, such as age, screening history, type
of Papanicolaou smear, and history of
immunosuppression.
 Other guidelines have also suggested screening
less frequently than annually after three consecutive
normal annual Papanicolaou tests and pelvic
examinations. Yet there are not many data to
support these recommendations.
Risk of Cervical Cancer
Associated with Extending the
Interval between Cervical-Cancer
Screenings

AU: Sawaya et al
SO: New Eng J of Medicine, Volume 349, Number 16;
October 16, 2003
 Methods

 We determined the prevalence of biopsy-proven

cervical neoplasia among 938,576 women younger
than 65 years of age, stratified according to the
number of previous consecutive negative
Papanicolaou tests. Using a Markov model that
estimates the rate at which dysplasia will progress
to cancer, we estimated the risk of cancer within
three years after one or more negative
Papanicolaou tests, as well as the number of
additional
 Papanicolaou tests and colposcopic examinations
that would be required to avert one case of cancer
given a particular interval between screenings.
 Result

 Among 31,728 women 30 to 64 years of age who

had had three or more consecutive negative tests
 The prevalence of biopsy-proven cervical
intraepithelial neoplasia of grade 2 was 0.028 %
 The prevalence of grade 3 neoplasia was 0.019 %
 None of the women had invasive cervical cancer
 Result

 According to our model, the estimated risk of cancer

with annual Papanicolaou tests for three years :
 2 in 100,000 among women 30 to 44 years of age,
 1 in 100,000 among women 45 to 59 years of age,
 1 in 100,000 among women 60 to 64 years of age;
 these risks would be 5 in 100,000, 2 in 100,000, and 1
in 100,000, respectively, if screening were performed
once three years after the last negative test.
Result
 To avert one additional case of cancer by
screening 100,000 women annually for three
years rather than once three years after the
last negative test, an average of 69,665
additional Papanicolaou tests and 3861
colposcopic examinations would be needed
in women 30 to 44 years of age and an
average of 209,324 additional Papanicolaou
tests and 11,502 colposcopic examinations in
women 45 to 59 years of age.
Conclusion

 As compared with annual screening for three

years, screening performed once three years
after the last negative test in women 30 to 64
years of age who have had three or more
consecutive negative Papanicolaou tests is
associated with an average excess risk of
cervical cancer of approximately 3 in
100,000.
Colorectal cancer screening:
an overview of available and
current recommendations

Early DS, Southern Medical Journal, 92

(3):258-265
 Colorectal cancer screening
 Skrining pd asimtomatik dpt menurunkan
insidensi dan kematian
 Database medline: artikel yg memuat
rasional skrining kanker colorectal, metode
yg digunakan, hasil guna dan rekomendasi
yg digunakan saat ini
 Hasil: metode: flexible sigmoidoscopy, fecal
blood test, barium enema, colonoscopy.
Metode yg digunakan dan frekwensi skrining
tergantung dr risiko
Colorectal cancer screening

 Penerimaan skrining oleh pasien dan

dokter belum optimal
 Masih diperdebatkan:
 Potensi skrining untuk mencegah
kematian dari ca colorectal,
 Cost effectiveness jika digunakan
untuk populasi umum.
Terima Kasih