Evidence-based medicine in Clinical practice

Promoting EBM Group Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand

What does EBM mean?

Integration of

Best research evidence Clinical expertise Patient values

Combinations of appropriate and timely utilization of available evidence to improve clinical expertise and patient values leading to the best practices

How do we practice EBM?

Step 1: Converting the need for information into an answerable clinical question Step 2: Tracking down the current best evidence to answer that question Step 3: Critically appraising the evidence Step 4: Integrating evidence into clinical practice Step 5: Evaluation of executing steps 1-4 above

Process of EBM
clinical question searching evidence

critical appraisal
using evidence evaluation

Step 1: Asking an answerable question

1. Asking an answerable question

Type of questions
Background questions Foreground questions

1. Asking an answerable question

Background questions: - Ask for general knowledge about a disorder - Components: what, when, where, why, whom, how Example: What is the definition of preterm
labor?

1. Asking an answerable question

Foreground questions: - Ask for specific knowledge about managing patient with a disorder - Components: patient, intervention, comparison, outcome Example: What is the best treatment of
preterm labor?

Foreground: Four-part clinical question

The Patients and/or Health Problem Intervention Comparison Clinical outcome

Intervention x for clinical outcome y in patient/problem z

Foreground: Four-part clinical question

The Patients: pregnant women with preterm labor Intervention: calcium channel blocker Comparison: other tocolytics Clinical outcome: prolongation of pregnancy
Is calcium channel blocker more effective in prolongation of pregnancy than other tocolytics?

Step 2: Searching evidence

Categories of evidence
I: RCT Ia: Evidence from meta-analysis of RCTS Ib: Evidence from at least one RCT II: Controlled trials IIa: Evidence from at least one controlled study without randomization IIb: Evidence from at least one controlled study with quasi-randomization III. Evidence from descriptive studies IV. Evidence from expert committee reports and/or clinical experience of respected authorities

2. Searching evidence
Search term: keywords Search Database

Evidence-based database: systematic review & meta-analysis Medical database: original randomized controlled trial (RCT)

Study design/search Clinical questions: therapy, harm, systematic review, diagnosis, prognosis

Search database
Evidence-based databases EBM online (http://ebm.bmjjournals.com) Cochrane Library CRD (http://nhscrd.york.ac.uk) Clinical evidence (http://www.clinicalevidence.com) Medical database PubMed Scientific information (http://wwwscirus.com) Proquest, OVID, ScienceDirect

Two types of reviews

Traditional

(narrative) review

Describing

finding of results Maybe no systematic search No critical appraisal No meta-analysis

Systematic Overview

review

Step 3: Critical appraisal

Types of clinical problems

Therapy Systematic Diagnosis

review

Prognosis
Harm

Three principles of critical appraisal

Valid: Less bias Important: Significant results Application: Considering a specific patient

Worksheet for

Therapy

Valid: Therapy
Items Yes/No Note

1.

Was the assignment of patients to treatments randomised? Was the randomisation list concealed? Were all patients analysed in the groups to which they were randomised (intention-to-treat)? Were patients and clinicians kept "blind" to treatment? Were the groups treated equally, apart from the experimental treatment (co-intervention)? Were all patients who entered the trial accounted for at its conclusion (follow up complete)?

2. 3. 4. 5. 6.

Important: Therapy
Number Absolute risk Relative risk Needed to reduction/ reduction/ Treat (NNT) increase (ARR/ARI) increase (RRR/RRI) /Harm (NNH)
1/ARR

Incidence

CER

EER

(CER-EER)/CER

CER-EER
1/ARI

Example
event rate

Tria RRR = l CER EER (ICER-EERI)/CER

ARR= ICER-EERI

Number needed to treat (NNT = 1/ARR)

1 50% 25% 0.05 0.025

(50-25)/50 = 0.5 = 50%

(0.05-

50-25 = 25% 1/25% = 4 0.05-0.025 1/0.025%

Application: Therapy
Items Yes/No Note

1.

Is your patient so different from those in the study that its results cannot apply?

2. Is the treatment feasible in your setting?

3.

Are they met by this regimen and its consequences- benefit and harm? Do your patient and you have a clear assessment of their values and preferences?

4.

Worksheet for

Systematic Review

Valid: Systematic review

Item
Yes/No Note

1. Is it an systematic review of randomized trials of the treatment you are interested in? 2. Does it include a method section described the finding and including all the relevant trials?

3. Does it include a method section described the assessing their individual validity? 4. Were the consistency of individual study considered in the method?

Important: Systematic Review

Same as Therapy
Occurrence of diseases Relative risk reduction (RRR) Absolute risk reduction (ARR) Number Needed to Treat (NNT)

Control Experimental event rate event rate (CER) (EER)

(CEREER)/CER

CER-EER

1/ARR

Application: Systematic Review

same as Therapy
Item
Yes/No Note

1.

Is your patient so different from those in the study that its results cannot apply? Is the treatment feasible in your setting? Are they met by this regimen and its consequences- benefit and harm? Do your patient and you have a clear assessment of their values and preferences?

2.
3.

4.

Worksheet for

Diagnosis

Valid: Diagnosis
Item
Yes/No Note

1.

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

2. Was the diagnostic test evaluated in an appropriate spectrum of patients (like those in whom it would be used in practice)?
3. Was the reference standard applied regardless of the diagnostic test result?

Important: Diagnosis
Standard result Positive Negative
b d b+d

Total
a+b c+d a+b+c+d

Test result

Positive Negative Total

a c a+c

Sensitivity = a / (a+c) Specificity = d / (b+d) LR+ = sensitivity /(1-specificity) LR- = (1-sensitivity) / specificity Positive predictive value = a /(a+b) Prevalence = (a+c) / (a+b+c+d) Pre-test odds = prevalence / (1-prevalece) Post-test odds = pre-test odds * LR Post-test probability = posttest odds /(1+ posttest odds)

Application: Diagnosis
Item
1.
Yes/No Note

Is the diagnostic test available, affordable, accurate, and precise in your setting?

2. Are the results applicable to my patients? 3. Will the results change my management? 4. Will patients be better off as a result of this test?

Worksheet for

Prognosis

Valid: Prognosis
Item
1.
Yes/No Note

Was a defined, representative sample of patients assembled at a common (usually early) point in the course of their disease? Was patient follow-up sufficiently long and complete? Were outcome criteria applied in a blind fashion?

2.

3.

4.

If subgroups with different prognoses are identified, was there adjustment for important prognostic factors?

Important: Prognosis
Item
1.
Yes/No Note

How likely are the outcomes over time?

2. How precise are the prognostic estimates?

Application: Prognosis
Item
1. Were the study patients similar to your own? 2. Can I use the results in managing patients in my practice?
Yes/No Note

Worksheet for

Harm

Valid: Harm
Item Yes/No Note

1.

Ware there clearly groups of patients, similar in all important ways?

2. Ware treatment exposures and clinical outcomes measured the same ways in both groups? 3. Was the follow-up of study patients complete and long enough? 4. Do the results satisfy for causation?

Important: Harm
Item
1.
Yes/No Note

How strong is the association between exposure and outcome?

2. How precise are the prognostic estimates?

Important: Harm
Adverse outcome
Positive (Case) Exposure to treatment Yes (Cohort) No (Cohort) Total
a c a+c

Negative (Control)
b d b+d

Total
a+b c+d a+b+c+d

Odds Ratio = (a/c) / (b/d) = ad/bc

RR

= [a/(a+b)]/[c/(c+d)]

Application: Harm
Item
1.
Yes/No Note

Is your patient so different from those in the study that its results cannot apply?

2. Was the duration of follow-up adequate?

3. Was the risk increase so that you attempt to stop the exposure? 4. Do your patient and you have a clear assessment of their values and preferences?