Evidence Based Medicine Critical Appraisal study design

Evidence Based Medicine Critical Appraisal study design

This is an assignment that focuses on the evidence based medicine critical appraisal study. The paper also focuses on the study design and treatment.

Evidence Based Medicine Critical Appraisal study design

Scenario: You are reviewing Mr Burns, a 59-year-old chronic smoker who was admitted to the ED 6 days ago for an acute myocardial infarction (ST-segment elevation). He is now stable; however, his latest blood tests show slightly elevated LDL Cholesterol (2.2 mmol/L). Mr Burns is currently taking 40mg of simvastatin. You will also ask yourself, should I switch him from simvastatin 40mg to simvastatin 40mg + ezetimibe 10mg? Task: To help you in answering this question, you are to critically appraise the study “Ezetimibe added to Statin Therapy after Acute Coronary syndromes (https://www.nejm.org/doi/full/10.1056/NEJMoa1410489) by answering the following questions: Study design questions

1. Firstly, what is the study design (e.g. RCT, cohort study, case series)? (0.5 mark)

2. Secondly, was the study placebo controlled? What was the study placebo controlled for? (1 mark)

3. Thirdly, are the treatment and control groups comparable? (1 mark)

4. Fourthly, why are blinding techniques used in clinical trials? Who was blinded in this trial? (1 mark)

5. Then, was the analysis methodology (of results) plan a priori or post-hoc? (1 mark)

6. Also, who funded the study? Are there any conflicts of interests involving researchers / investigators and is this likely to have biased the study findings? (1.5 marks)

7. Lastly, was the primary endpoint/outcome measure in this study clinically appropriate? (1 mark) Statistical Analysis, Reporting of Results and also Clinical Significance Questions

1. Were the results (of the primary endpoint) statistically significant (p< 0.05 or 95% CI relative risk/hazard ratio does not include 1)? (1 mark) 2. Secondly, determine the absolute risk increase (ARI) and numbers needed to harm (NNH) for this study with regards to reported myopathy adverse events between treatment groups. Are myopathy related events significantly more common in the intervention group? Comment on the risks of rhabdomyolysis or myopathy reported between treatment groups. (2.5 marks) 3. Who is the corresponding (primary) author for the report? Would he/she be an ‘Opinion leader’ in their field? (1 mark)

4. Additionally, is the data applicable to the current patient (age, sex, race, etc.)? (1 mark) 5. If Mr Burns had very impaired renal function (e.g. calculated creatinine clearance <20ml/min) would the study findings be applicable to him? (0.5 mark) 6. Were appropriate doses usage in the study? (1 mark) 7. Subsequently, what is the quality of the journal in which the results were report? (0.5 mark) 8. Is the report complete e.g. full article, or an abstract/poster? (0.5 mark) 9. Lastly, are the results from this trial clinically relevant for Mr Burns? (Non-assessed item)