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EBM prognostic

Kanti Ratnaningrum
Risk and Prognosis:

• Risk factors: • Prognostic factors:


Conditions that can Conditions that,
be identified in well when present in
persons and, when persons already
present, are known to have
associated with an disease, are
increased risk of associated with an
acquiring disease outcome of the 2
Onset of Acute
Well Myocardial Infarction Outcomes

Death
Reinfarction
RISK PROGNOSIS Other

Risk Factors Prognostic (Poor) Factors


Age Age
Male Female
Cigarette smoking Cigarette smoking
Hypertension Hypotension
LDL / HDL Anterior infarction
Inactivity Congestive heart failure
Ventricular arrhythmia

Differences between risk and prognostic factors for acute myocardial infarction

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Natural history/Clinical course:

• Natural history:
The evolution of disease without medical
intervention
• Clinical course:
The evolution of disease that come under
medical care and is then treated in a variety of
ways that might affect the subsequent course
of events
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Describing outcomes of disease:

• Should include the full range of


manifestations that would be considered
important to patients (5Ds):
1. Death  kematian
2. Disease  penyakit
3. Disability  kecacatan
4. Discomfort  kegelisahan
5. Dissatisfaction  ketidakpuasan
6. (Destitution)  kemiskinan

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Rates commonly used to describe
prognosis:
Rate Definition*
5-year survival Percent of patients surviving 5 years from some
point in the course of their disease
Case fatality Percent of patients with a disease who die of it
Disease-specific Number of people per 10,000 (or 100,000)
mortality population dying of a specific disease
Response Percent of patients showing some evidence of
improvement following an intervention
Remission Percent of patients entering a phase in which
disease is no longer detectable
Recurrence Percent of patients who have return of disease
after a disease-free interval

*Time under observation is either stated or assumed to be sufficiently


long so that all events that will occur have been observed
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Skenario klinis
• Seorang ODHA laki-laki berusia 38 tahun datang ke klinik VCT
untuk berkonsultasi tentang diagnosis TB yang baru saja dia
dapatkan dari dokter berikut OAT yang telah diberikan. Dia
ingin menanyakan apakah kondisi ini dapat memperpendek
umurnya.
• Dari data didapatkan pasien tinggal bersama orang tuanya
yang penuh kasih sayang.
• Nilai CD4 pasien terakhir 240 cell/mm3
• Pasien belum pernah mendapat OAT sebelumnya
• Dokter ingin tahu seberapa besar OAT yang diberikan pada
ODHA dapat mempengaruhi umurnya
Practice of EBM
• Step 1: Converting the need for information (about prevention,
diagnosis, prognosis, therapy, causation, etc.) into an
answerable question
• Step 2: Tracking down the best evidence with which to answer
that question
• Step 3: Critically appraise that evidence for the validity
(closeness to the truth), impact (size of the effect), and
applicability (usefulness in our clinical practice)
• Step 4: Integrating the critical appraisal with our clinical
expertise and with our patient’s unique biology, values, and
circumstances
• Step 5: Evaluating our effectiveness and efficiency in executing
steps 1-4 and seeking ways to improve them both for next time

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Clinical question about prognosis

Patient or Intervention Comparison Outcomes


Problem
Pasien DOTS - mortality
usia 38
tahun
dengan
diagnosi
s HIV-TB

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Pertanyaan klinis
• Apakah pemberian OAT dengan DOTS pada
pasien HIV-TB dapat memperlambat
kematiannya?
Practice of EBM
• Step 1: Converting the need for information (about prevention,
diagnosis, prognosis, therapy, causation, etc.) into an
answerable question
• Step 2: Tracking down the best evidence with which to answer
that question
• Step 3: Critically appraise that evidence for the validity
(closeness to the truth), impact (size of the effect), and
applicability (usefulness in our clinical practice)
• Step 4: Integrating the critical appraisal with our clinical
expertise and with our patient’s unique biology, values, and
circumstances
• Step 5: Evaluating our effectiveness and efficiency in executing
steps 1-4 and seeking ways to improve them both for next time

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Search Strategy
 Medline database:
http://www.ncbi.nlm.nih.gov/pubmed/
• Using the Clinical Queries function of PubMed:
– Key words:
• “natural history” AND
• “HIV”
– Clinical Study Categories: “prognosis”
– Scope: “Narrow”
Searching the Evidence
• Natural History and Factors Associated with Early and
Delayed Mortality in HIV-Infected Patients Treated of
Tuberculosis under Directly Observed Treatment
Short-Course Strategy : A Prospective Cohort Study in
India

• Alvarez-Uria G, Naik PK, Pakam R, Bachu L, Midde M.


• Interdisciplinary Perspectives on Infectious Diseases
Volume 2012, ArticleI D 502012, 9 pages

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Practice of EBM
• Step 1: Converting the need for information (about prevention,
diagnosis, prognosis, therapy, causation, etc.) into an
answerable question
• Step 2: Tracking down the best evidence with which to answer
that question
• Step 3: Critically appraise that evidence for the validity
(closeness to the truth), impact (size of the effect), and
applicability (usefulness in our clinical practice)
• Step 4: Integrating the critical appraisal with our clinical
expertise and with our patient’s unique biology, values, and
circumstances
• Step 5: Evaluating our effectiveness and efficiency in executing
steps 1-4 and seeking ways to improve them both for next time

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Clinical Question Epidemiological
domain study type
Diagnosis How accurate are tests Cross-sectional
used to diagnose disease? study
Prognosis What are the Cohort
consequences of having a (longitudinal) study
disease?
Therapy How does treatment RCT (or
change the course of systematic review
disease? of RCTs)
Harm What conditions lead to Cohort or case-
(Etiology/ disease? control study
causation)

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Is this evidence about prognosis
valid?
1. Was a defined, representative
sample of patients assembled
at a common point in the
course of their disease?
– Penelitian ini merupakan
studi cohort prospektif
– dengan konsekutif
sampling

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Is this evidence about prognosis valid?

2. Was follow-up of study patients sufficiently


long and complete?
– Follow-up terhadap 1000 pasien dilakukan
selama 24 bulan dengan kematian kumulatif
sebanyak 388 pasien
– Pada penelitian ini tidak dijelaskan berapa jumlah
pasien yang masih hidup pada akhir pengamatan

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Is this evidence about prognosis valid?

3. Were objective outcome criteria applied in a “blind”


fashion?
– Cause of death was ascertained by hospital notes, death
reports dari VFHCS database
– Penilaian outcome kematian tidak dijelaskan apakah
blinded atau tidak

Eksekusi kematian  tidak perlu “blind”

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Is this evidence about prognosis valid?
4. If subgroups with different prognoses are identified:
• Was there adjustment for important prognostic factors?

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• Was there validation in an independent group
of “test-set” patients?
• Tidak ada test-set pasien dalam penelitian ini
Is this valid evidence about prognosis important?

1. How likely are the outcomes over time?


2. How precise are the prognostic estimates?
– From our study, we found that, at a median follow-up of
10.4 bulan , mortality was 38.8%
– Pasien dibagi menjadi 2 kelompok: penilaian follow-up
mortality dalam 3 bulan pertama dan setelah 3 bulan.

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Can we apply this valid, important evidence about prognosis
to our patient?

1. Is our patient so different from those in the


study that its results cannot apply?
– tidak
2. Will this evidence make a clinically important
impact on our conclusions about what to
offer or tell our patient?
– ya

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Practice of EBM
• Step 1: Converting the need for information (about prevention,
diagnosis, prognosis, therapy, causation, etc.) into an
answerable question
• Step 2: Tracking down the best evidence with which to answer
that question
• Step 3: Critically appraise that evidence for the validity
(closeness to the truth), impact (size of the effect), and
applicability (usefulness in our clinical practice)
• Step 4: Integrating the critical appraisal with our clinical
expertise and with our patient’s unique biology, values, and
circumstances
• Step 5: Evaluating our effectiveness and efficiency in executing
steps 1-4 and seeking ways to improve them both for next time

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Resolution of the Case
Sesuai umur pasien (38th) maka kondisi ini dapat
meningkatkan risiko kematian sebesar 1,24x dibanding
pasien usia < 35th dalam 3 bulan pertama pengobatan

Sesuai dengan nilai CD4 terakhir (240cell/mm3), maka kondisi


ini dapat meningkatkan risiko kematian sebesar 1,2x
dibandingan pasien dengan nilai CD4 diatas > 250cell/mm3
dalam 3 bulan pertama pengobatan

Setelah menjalani pengobatan > 3bulan, risiko kematian


akibat TB menjadi tidak bermakna

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