RACE611 CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE Prognostic study

Transcription

1 RACE611 CLINICAL EPIDEMIOLOGY AND EVIDENCE-BASED MEDICINE Prognostic study Assoc.Prof.Dr.Atiporn Ingsathit Master of Science Program in Medical Epidemiology and Doctor of Philosophy Program in Clinical Epidemiology Section for Clinical Epidemiology & Biostatistics Faculty of Medicine Ramathibodi Hospital Mahidol University rama.org/ Academic Year 2015 Semester 1

2 REFERENCES 1. Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology. The Essentials. 4 th Ed. Baltimore: Lippincott Williams & Wilkins, 2005: Haynes RB, Sackett DL, Guyatt GH, Tugwell P. Clinical epidemiology. How to do clinical practice research, 3 rd Ed. Philadephia: Lippincott Williams & Wilkins, 2006: Heneghan C, Badenoch D. Evidence-based medicine toolkit. 2 nd Ed. Massachusetts: Blackwell Publishing, 2006: Guyatt G, Rennie D, Meade O M, Cook J D. Users guides to the medical literature. Essentials of evidence-based clinical practice. Chicago: AMA Press, 2008:

3 Critical appraisal for prognostic study Appraising an article about prognosis Scenario At your clinic a 71-year-old man complained that left side of his face, arm, and body was suddenly weak 6 hours ago. It s just completely recovered last hour before coming to see you. He was frightened that he would have a stroke and be a burden for his family. He has no underlying disease. He s quite healthy and seriously concern on keeping healthy. He doesn t drink alcohol or smoke. His family of origin has longevity until 90 to 100 years old. Your physical examination on him found to be normal. He asked you whether he was going to have a real stroke recently and how big the chance is. From his question, you begin medical literature search on prognosis of TIA patients and received the following paper (Appendix 4) ASSIGNMENTS A. What is your clinical question? P: I: C: O: B. What are your search term? C. Read the article and critically appraise its validity using the Appraisal Guides for an Article on prognosis (Appendix 1). D. Appraise the results of the study, discussing the rationale for each in worksheet for prognostic study (Appendix 2). E. Create critical appraisal topic (CAT) from this study (Appendix 3).

4 SUGGESTED READING 1. Haynes RB, Sackett DL, Guyatt GH, Tugwell P. Clinical epidemiology. How to do clinical practice research, 3 rd Ed. Philadephia: Lippincott Williams & Wilkins, 2006: Guyatt G, Rennie D, Meade O M, Cook J D. Users guides to the medical literature. Essentials of evidence-based clinical practice. Chicago: AMA Press, 2008: Appendix (include articles assign for reading) Appendix 1: Guideline for Critical Appraisal on Prognostic study Guyatt G, Rennie D, Meade O M, Cook J D. Users guides to the medical literature. Essentials of evidence-based clinical practice. Chicago: AMA Press, 2008:

5 PROGNOSIS EBM Elective CEU TABLE 1D-1 Users Guides to an Article About Prognosis How serious is the risk of bias? Was the sample of patients in a study representative? Were the patient classified into prognostically similar groups? Was study follow-up sufficiently complete? Were study outcome criteria objective and unbiased? What are the results? How likely are the outcomes over time? How precise are the estimates of likelihood? How can I apply the results to patient care? Were the study patients and their management similar to those in my practice? Was follow-up sufficiently long? Can I use the study results in the management of patients in my practice?

6 Appendix 2: Prognostic worksheet Prognosis A. How serious is the risk of bias? Was the sample of patients in a study representative? Were the patient classified into prognostically similar groups? Was study follow-up sufficiently complete? Were study outcome criteria objective and unbiased? B. What are the results? How likely are the outcomes over time? How precise are the estimates of likelihood? C. How can I apply the results to patient care? Were the study patients and their management similar to those in my practice? Was follow-up sufficiently long? Can I use the study results in the management of patients in my practice?

7 Appendix 3: Critical appraisal topic (CAT) for prognostic study Clinical Question: Citation: A. Study Characteristics: 1. Patients included 2. Exposure 3. Outcome B. Validity Criteria: 1. Sample of patients, representative? 2. Patients sufficiently homogenous with respect to prognostic risk? 3. Was follow-up sufficiently complete? 4. Were objective and unbiased outcome criteria used? C. Results [adjust the number of rows as needed]: Outcome Point Estimate (Specify if RR or OR) 95% Confidence Interval Total D. Applicability: 1. Were the study patients and their management similar those patient in my practice? 2. Was follow-up sufficiently long? 3. Can I use the results in the management of patients in my practice? Author s Conclusion: Reviewer s Conclusion: Reviewer: Date:

8 Appendix 4: Reading article