PENAPISAN TEKNOLOGI DIAGNOSTIK

Bambang Udji Djoko Rianto

The technology assesment iterative loop

Burden of illness Monitoring & reassessment Synthesis & implementation

Efficacy

Screening & diagnosis

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

Negara
AS Jepang Perancis Belgia Jerman Barat Denmark Belanda Inggris Itali

Jumlah CT Scanner

CT scanner/juta penduduk

1986
3000 3300 264 64 423 23 45 149 210

1988
4991 5448 350 118 595 ? 83 204 338

1986
12.8 27.5 4.7 6.4 6.9 4.6 3.2 2.7 3.5

1988
21.7 44.3 6.3 12.1 9.8 ? 5.7 3.6 5.9

Jumlah & rerata MRI/ 1 juta penduduk

Negara

Jumlah MRI Rerata MRI/juta penduduk 1986 1988 1986 1988 0.5 0.1 0.5 0.7 0.7 0.4 0.3 0.2 5.0 2.0 0.6 0.7 1.5 0.5 0.5 0.5

AS 110 1150 Jepang 10 256 Perancis 29 34 Belgia 7 7 Jerman Barat 41 91 Belanda 2 7 Inggris 14 28 Itali 13 29

Test-treatment thresholds

Do not test
Test, & treat on the basis of the tests results

Do not test

Do not treat 0 .10

Get on with treatment .70 .80 .90

.20 .30 .40

.50 .60

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 + T e s t -

True positive
False negative

False positive
True 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 + b a+b

+ Hasil test
-

c a+c

d b+d

c+d
N

Sensitivity Specificity Accuracy

= a / (a+c) = d / (b+d) = (a+d) / N

+ PV = a / (a+b) - PV = d/ (c+d) Prevalence = (a+c) / N

2 Pendekatan ttg penampilan diagnosis

Prevalensi Sensitivitas/ Spesifisitas Nilai ramal

Pre-test probability

Rasio kemungkinan

Post-test 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 + b a+b

+ Hasil test
-

c a+c

d b+d

c+d
N

a/a+c LR (+) = -------b/b+d

c/a+c LR (-) = -------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 (kadangkadang 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

Prompt treatment

morbiditas 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 physicians 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.
2. 3.

4. 5.

Technical performance Diagnostic performance Diagnostic impact keputusan diagnostik Diagnostic impact keputusan terapi 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 twoyear period and > 90 % having been screened at least once. Questions remain about optimal screening strategies. One key question is the optimal frequency of testing. Costbenefit 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