Ther 202: Pharmacotherapeutics

EXAM

QUICK STEPS IN THE CRITICAL APPRAISAL OF ARTICLES ON THERAPY: EBM FOR THE BUSY CLINICIAN
LECTURE 15
OUTLINE I. Critical appraisal II. Steps in critical appraisal III. Evaluating Validity IV. Evaluating Results V. Evaluating Applicability

25 July 2012

Dr. Cecile A. Jimeno

Otherwise, toss it out or look for other articles. Accept it only if there is no alternative.

I. CRITICAL APPRAISAL
Objectives of a Quick Critical Appraisal To review the process of critical appraisal (in relation to an article on therapy) To learn some simple and efficient ways to obtain valid journal articles To understand key concepts which are important in doing a good critical appraisal To practice the skill of critical appraisal Why quick appraisal? We need to simplify our retrieval and review of articles We do NOT have to read everything about a specific problem or topic; if we can ask a focused clinical question we can also do a systematic literature search, as well as do an efficient critical appraisal. However, even with a well designed and systematic literature search, we still end up with several journal articles to retrieve and read.

Critical Appraisal Technique which increases the effectiveness of reading. Enables readers to exclude studies that are too poorly designed to inform practice. Allows us to concentrate on a more systematic evaluation of good quality studies & then to extract their salient points. CAT VS Critical Appraisal Critical appraisal: the process of evaluating the medical literature for its validity, importance or applicability CAT= critically appraised topic CAT is a summary of the process of critical appraisal which is focused on a specific clinical question Appraising an article on claims of effectiveness
Guide questions 1. Was the assignment of patients to treatment randomized? 2. Was randomization concealed? 3. Were follow up adequate? 4. Were patients analyzed under the groups to which they were originally randomized? 5. Were the patients, health workers, and study personnel blind to treatment? 6. Were patients in the treatment and control groups similar with respect to known prognostic factors? 7. How large was the treatment effect? 8. How precise was the estimate of treatment effect? 9. Can the results be applied to my patient care? 10. Were all clinically important outcomes considered? 11. Are the likely treatment benefits worth the potential harms and costs? Comments

VALIDITY

IMPORTANCE /RESULTS APPLICABILITY

II. STEPS IN CRITICAL APPRAISAL

Answer 3 sets of question (V-I-A) o Are the results of the study valid? (VALIDITY) o What are the results? (IMPORTANCE) o How can I apply the results to patient care? (APPLICABILITY)

III. EVALUATING VALIDITY

Do the results reflect an unbiased estimate of the treatment effect, or have they been influenced in some systematic fashion to lead to a false conclusion? If the answer is YES, then the study is worth reading

Appraisal Checklist: RAMMbo Study Biases To review the process of critical appraisal (in relation to an article on therapy) 1. Recruitment 2. Who did the subjects represent? Allocation o Central computer randomization is the best to use in allocation concealment and also the most valid. o Use of envelopes in allocation concealment is actually doubtful. o Use of birthdays or assigning alternate days is actually not useful in allocation since these are not randomized. Was the assignment to treatments randomized? o Randomization is done to make two groups equal, to avoid bias, to ensure 50-50 chance for each patient to be allocated to one group or the other, thus, ensuring that results are seen due to the treatment NOT due to the differences in the characteristics of two groups. Were the groups similar at the trials start? o Check for the baseline characteristics which are usually found in tables in RCTs. 3. Maintenance: Adequate follow-up and Analyzed in the original allocation Adequate follow-up rate: losses to follow-up o 5% losses to follow up probably lead to little bias o >20% poses serious threats to validity o Characteristics and similarities in the characteristics of losses on each group (e.g. sex, age) are also important and should be checked Were the groups treated equally? o This applies not only to the intervention or exposure itself but also to the actual care to the subjects of the study (i.e. identical care). Were outcomes ascertained & analyzed for most patients? o Intention-to-treat principle: analyze participants in the groups to which they were randomized. Exception: if patient is found on BLIND reassessment to be ineligible based on prerandomization criteria. 4. Measurements Were patients and clinicians blinded to treatment? o How about the Participants? Investigators? Outcome assessors? Analysts? o Blinded is done to minimize measurement bias. o Most important to use "blinded" outcome assessors when outcome is not objective! o Papers should report WHO was blinded and HOW it was done. Were measurements objective & standardized o Measurement is said to be objective if appropriate blinding is maintained all throughout the study. 5. Placebo Effect This is attributable to the expectation that the treatment will have an effect. 6. Chance Effect Two methods of assessing the role of chance: P-values (Hypothesis Testing) o Use statistical test to examine the null hypothesis

Natividad, Rex, Francis

One Pride, One Five! UPCM 2015

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Ther 202 DRUG INTERACTIONS AND PHARMACOVIGILANCE

Associated with p values - if p<0.05 then result is statistically significant Confidence Intervals (Estimation) o Estimates the range of values that is likely to include the true value o When the confidence interval does not include the no effect value of 0 the result is statistically significant 7. Real Effects
Are the results valid? 1. Were patients randomized to treatment groups 2. Was randomization concealed? 3. Was follow-up rate adequate? 4. Were patients analyzed under the groups to which they were originally randomized? 5. Were patients blinded to group allocation? 6. Were clinicians blinded to group allocation? 7. Were outcome assessors blinded to group allocation? 8. Were patients in the treatment and control groups similar with respect to known prognostic variables? RANDOMIZATION ALLOCATION & CONCEALMENT ADEQUATE FOLLOW-UP ANALYZED TO ORIGINAL RANDOMIZATION MEASUREMENTS blind or objective

See #2

IV. EVALUATING RESULTS

What are the results? These includes the following measures of efficacy: o Size and precision of the treatment effect o RR, ARR, RRR o Hazard ratio o NNT, NNH o Point estimate, confidence interval o P-value Best estimate of effect will be the study findings themselves; precision is always superior in larger studies. You dont have to compute these measures yourself. Just have to know how to analyze the results.

V. EVALUATING APPLICABILITY
Evaluate once you found that the study is valid and the results are good. Can you generalize the results to your patient? o You should hesitate to institute a treatment only if your patient is too dissimilar from those who participated in the trial If the results are generalizable to your patient, what is the net impact of the treatment? o Consider risk-benefit ratio o For example even effective therapy might be witheld when a patients prognosis is already good without treatment especially when the treatment is accompanied by important side effects and toxicity. END OF TRANSCRIPTION Hi! You can check Dr. Jimenos powerpoint slide to help you more in your assignment! Its uploaded in our Dropbox account (Folder name: Dr. Jimeno - Critical Appraisal HW).

Jayne, Furqaan, Pao

One Pride, One Five! UPCM 2015

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