Research Study Design and Statistis Aug 2008-1

Research Study Design and Statistis Aug 2008-1 - Research...

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Unformatted text preview: Research Study Design and Statistical Methods for Cardiology Nathan D. Wong, PhD, FACC Professor and Director Heart Disease Prevention Program Division of Cardiology University of California, Irvine Why are papers rejected for publication? (The Top 11 Reasons) 1. The study did not address an important scientific issue 2. The study was not original 3. The study did not actually test the authors hypothesis 4. A different type of study should have been done 5. Practical difficulties led the authors to compromise on the original study protocol (e.g., recruitment, procedures) Greenhalgh T, BMJ 1997; 15: 243-6 Reasons 6-11 for Paper Rejection 6. The sample size was too small 7. The study was uncontrolled or inadequately controlled 8. The statistical analysis was incorrect or inappropriate 9. The authors drew unjustified conclusions from the data 10. There is a significant conflict of interest among authors 11. The paper is so badly written that it is incomprehensible Outline Elements of Designing a Research Protocol Selecting a Study Design Which is best for answering your question? Selection and Classification of Study Variables (e.g., predictors and outcomes) Sample size and power considerations Choice of statistical procedures for different study designs Nine Key Elements of a Research Study Protocol Background Hypotheses Clinical Relevance Specific Aims / Objectives Methodology Power / Sample Size Measures and Outcomes Data Management Statistical Methodology ( UCI-SOM Deans Scientific Review Committee: http :// www.rgs.uci.edu/ora/rp/hrpp/deansscientificreview.htm) Background A brief review of the problem to be studied and of related studies that generated the rationale and the central idea of the proposed study. Several pertinent references should be provided. Was the study original? Few studies break entirely new ground Many studies add to the evidence base of earlier studies which may have had other or more limitations Meta-analyses depend on literature containing multiple studies addressing a question in a similar manner Features Distinguishing New vs. Previous Studies Is the study in question bigger in sample size, or with longer-follow-up (e.g., adding to meta- analyses of previous studies)? Is methodology more rigorous (e.g., having addressed criticisms of previous ones)? Is the population studied different from that of previous studies (ages, gender, ethnic groups)? Does the new study address a clinical issue of sufficient importance so it is politically desirable even if not scientifically necessary? Greenhalgh T, BMJ 1997; 315: 305-8 Hypotheses The problem/s stated in the Background may generate a primary hypothesis and possibly one or two secondary hypotheses....
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This note was uploaded on 12/21/2011 for the course STEP 1 taught by Professor Dr.aslam during the Fall '11 term at Montgomery College.

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Research Study Design and Statistis Aug 2008-1 - Research...

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