Professional Documents
Culture Documents
Conflict of interest
Unjustified conclusion
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7. Expert opinion
8. Anecdote
Critical appraisal
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V.I.A
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Reliability: Are the results credible and (important) repeatable? Relevance: Will the results help me in my own (applicability) study or practice?
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Steps to EBM
1. Formulate an answerable focused clinical question - PICO model 2. Search the literature for the best external evidence 3. Critically appraise the evidence for its validity and usefulness/important 4. Implement the useful evidence in clinical practice 5. Evaluate the results
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Clinical Scenario
Can furosemide be used for rate control of atrial fibrillation (AF) in a patient with congestive heart failure (CHF)?
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Getting Started
1. Formulate research (PICO) question
Population: Patients with atrial fibrillation and CHF Intervention: furosemide Comparison: placebo Outcome: Mortality, effectiveness of rate control
3. Find paper (s) 4. Read to suit you! 5. Appraise the paper (s)
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Comparison (C)
Placebo
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Clinical problem
Define the search question Try another relevant resource Choose a resource/database Create a search strategy Create a search strategy Summarize the evidence
Poor yield
Adapted from: Sackett, D. et al. 2000. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd Edition. Toronto: Churchill Livingstone.
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NOTE: An absolute risk reduction of 0% would indicate that there is no difference between the groups.
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Risk Ratios
The relative risk is the risk of events among intervention patients as a proportion of the risk among patients in the control group For the same study the relative risk would be:
15% / 20% = 75% or 0.75
NOTE: A relative risk of 100% or 1 would indicate that there is no difference between the groups
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Odds Ratios
Odds of an event = no. of events / no. of non-events e.g. 51 boys/100 births Odds of boy = 51/49 = 1.04 Odds >1 means event more likely to happen than not Odds of an impossibility are zero Odds of a certainty are infinity Odds ratio = odds in intervention group / odds in control group
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Odds Ratios
When events are rare Odds (OR) and Risk (RR) are similar
As prevalence (control event rate/CER) and OR increase, the error in using OR as an approximation for RR becomes unacceptable.
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Absolute Risk Reduction = 0.6 - 0.4 = 0.2 = 20% Relative Risk = 0.4 / 0.6 = 0.67 = 67% Relative Risk Reduction = 1 0.67 = 0.33 = 33%
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Absolute Risk Reduction = 0.006 - 0.004 = 0.002 Relative Risk = 0.004 / 0.006 = 0.67 = 67% Relative Risk Reduction = 1 0.67 = 0.33 = 33% RRR is the same even though this drug is rubbish!
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results The p-value is calculated using statistical tests that take into account the study design, the variation within the data, and the sample size. a p-value of less than 0.05 is sufficient to say that the observed difference indicates an actual difference or statistical significant.
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actual result. CI can tell whether a result is significant ( statistical and clinical significant) but p-value only statistical significant) A 95% Confidence Interval of 0.1 2.0 tells that if you ran the trial again, there is a 95% chance getting a result somewhere between 0.1 and 2.0 Or if you conducted the trial 100 times you would get a result between 0.1 and 2.0 in 95 of those trials.
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Four possible outcomes from any study 1. Difference is clinically important and statistically significant i.e. important and real. 2. Of clinical importance but not statistically significant. sample size too small. 3. Statistically significant but not clinically important i.e. not clinically meaningful. 4. Neither clinically important nor statistically significant.
APPLICABILITY
Applicability of the study Discussion my patient so different from those in the study that the results cannot apply?
- Inclusion and exclusion criteria
Case scenario
76 year old male admitted to your clinics due to acute diarrhea for one week. Medication such as kaopectine, imodium had been given but in vain After consultation with a internist, the probiotic was prescribed. Diarrhea improved after 2-3 days.
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EBM
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No
YA
TIDAK
Judul Makalah
a. Apakah judul tidak terlalu panjang atau terlalu pendek? b. Apakah judul menggambarkan isi utama penilaian? c. Apakah judul cukup menarik? d. Apakah judul menggunakan singkatan selain yang baku?
a. Apakah merupakan abstrak satu paragraf, atau abstrak terstruktur? b. Apakah sudah tercakup komponen IMRAC (Introduction, methods, Results, Conclusion?) c. Apakah secara keseluruhan abstrak informatif? d. Apakah abstrak lebih dari 250 kata?
Terstruktur
Abstrak
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Metode
a. Apakah disebutkan desain, tempat & waktu penelitian? b. Apakah disebutkan populasi sumber (populasi terjangkau)? c. Apakah kriteria pemilihan (inklusi & eksklusi) dijelaskan? d. Apakah cara pemilihan subjek (teknik sampling) disebutkan? e. Apakah perkiraan besar sampel disebutkan & disebut pula alasannya? f. Apakah perkiraan besar sampel dihitung dengant rumus yang sesuai? g. Apakah observasi, pengukuran, serta intervensi dirinci sehingga orang lain dapat mengulanginya? h. Bila teknik pengukuran tidak dirinci, apakah disebutkan rujukannya? i. Apakah definisi istilah & variabel penting dikemukakan? j. Apakah ethical clearance
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Hasil
a. Apakah disertakan tabel deskripsi subjek penelitian? b. Apakah karakteristik subjek yang penting (data awal) dibandingkan kesetaraannya? c. Apakah dilakukan uji hipotesis untuk kesetaraan ini? d. Apakah disebutkan jumlah subjek yang diteliti? e. Apakah dijelaskan subyek yang drop out dengan alasannya? f. Apakah semua hasil di dalam tabel disebutkan dalam naskah? g. Apakah semua outcome yang penting disebutkan dalam hasil? h. Apakah subyek yang drop out diikutkan dalam analisis? i. Apakah disertakan hasil uji statistik (x2,t) derajat kebebasan (degree of freedom), dan nilai p?
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Diskusi
a. Apakah semua hal yang relevan dibahas? b. Apakah dibahas keterbatasan penelitian, dan kemungkinan dampaknya terhadap hasil? c. Apakah disebutkan kesulitan penelitian, penyimpangan dari protokol, dan kemungkinan dampaknya terhadap hasil? d. Apakah pembahasan dilakukan dengan meghubungkannya dengan teori dan hasil penelitian terdahulu? e. Apakah dibahas hubungan hasil dengan praktek klinis? f. Apakah disertakan kesimpulan utama penelitian? g. Apakah kesimpulan didasarkan pada data penelitian? h. Apakah efek samping dikemukakan dan dibahas? i. Apakah disebutkan hasil tambahan selama diobservasi? j. Apakah disebutkan generalisasi hasil penelitian? k. Apakah disertakan saran penelitian selanjutnya, dengan anjuran metodologis yang tpat?
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KHUSUS - EBM Menilai VIA (Validity, Important, Aplicability) Validitas 1. Apakah awal penelitian didefinisikan dengan jelas? Ya, awal penelitian dan tujuan penelitian dijelaskan secara rinci. 2. Apakah dinyatakan desain penelitian dengan jelas ?
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Important 1. Apakah outcome/hasil dipaparkan secara jelas (hasil uji statistic dengan hasil nilai P)? 2. Seberapa besarkah ketepatan estimasi outcome yang didapat dengan nilai OR,RR,PR dengan nilai korelasi 95% CI ?
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Aplicability
2. Apakah bukti ini akan mempunyai pengaruh yang penting secara klinis terhadap kesembuhan pasien kita tentang apa yang telah ditawarkan/diberikan kepada pasien kita? 12/30/2012 59