Writing the Proposal

2. Writing the Proposal Hooman Bakhshande , MD , PhD

4. Research Methodology

5. Types of the Study

6. انواع مطالعات کيفي Qualitative researchers aim to gather an in-depth understanding of human behavior and the reasons that govern such behavior. The qualitative method investigates the why and how of decision making, not just what, where, when. Hence, smaller but focused samples are more often needed, rather than large samples. کمي systematic empirical investigation of quantitative properties and phenomena and their relationships. The objective of quantitative research is to develop and employ mathematical models, theories and/or hypotheses pertaining to phenomena.

7. Usually, a study begins with a … • Question • who, what, when, where • Hypothesis • why (causality) exposures (dose, timing…), who, what, when, where, outcome

8. Study Types: Question Descriptive Hypothesis Analytic

9. Descriptive Studies • Aim: Description of desirable variables (disease, event, defined characteristic …) or their changes, according to PERSON, TIME & LOCATION • Data Sources: • Medical records • Registries and Surveillance systems data • Field/clinical data collection

10. Descriptive Studies • Case Series • Cross Sectional Study • Ecologic (Correlational) study

11. Case Report • Not a research type! • Used for documentation purposes

12. Case series • Clinical setting • Description of patients’ characteristics, diagnosis, treatments, outcomes, prognosis and survival • Determination of natural history of diseases • Different time axes for data collection (longitudinal/cross sectional) • Different types of data collection techniques • Sub-group comparisons and statistical modeling

13. Cross-Sectional Study • Prevalence Study • Exposure and outcome data should be collected at the same time • People with different states of exposure/outcome be enrolled the study (difference with case-series) •  Descriptive-Analytic • Sub-group comparisons and statistical modeling

14. Ecologic (Correlational) Study • Groups, not “individuals” as the units of study • Purpose: to make biologic inferences about effects on individual risks or to make ecologic inferences about effects on group rates

15. Analytic Studies How could we test a hypothesis? COMPARISON!

16. مطالعات هم گروهي آينده نگر Prospective Cohort

17. مطالعات هم گروهي گذشته نگر (تاريخي) Historical Cohort PRESENT PAST

18. مطالعات مورد – شاهديcase - control

19. کار آزمايي باليني کنترل شده تصادفيrandomized controlled clinical trial

20. Secondary Data Studies Narrative Review Article (Narrative Review) Systematic Systematic Review Meta Analysis

21. انواع مطالعات (کمي) • تحليلي (فرضيه ي پژوهشي) • مشاهده اي (observational) • هم گروهي (cohort) • مورد-شاهدي (case-control) • مداخله اي (interventional) • کارآزمايي باليني تصادفي شده کنترل دار • کار آزمايي باليني متقاطع • Community Trial • توصيفي (سوال پژوهشي) • گزارش بيماران (case series) • مقطعي (cross sectional) • مطالعات اکولوژيک (correlational)

22. Study Design

23. طراحي مطالعه • جمعيت مورد مطالعه • تعريف متغيرهاي مورد اندازه گيري، مواجهه ها و پيامدها • تعريف گروه هاي مواجهه/ بيمار و شاهد • تعريف زيرگروه هاي مورد مطالعه • روش هاي مقابله با خطاها و تامين روايي و پايايي • ساير نکات مرتبط با طراحي هاي تخصصي • مباحث اخلاقي

24. Population and Sampling

25. جمعيت هاي پژوهش • جامعه ي مرجع (reference population): جامعه اي است که نتايج پژوهش بايد به آن تعميم داده شود. • جامعه ي مورد مطالعه (study population): جامعه اي که مطالعه بر روي آن انجام مي شود • معيارهاي ورود/ خروج

26. Types of Sampling • Probability • Simple Random Sampling • Systematic Sampling • Strata Sampling • Cluster Sampling • Non-probability • Convenience Sampling • Quota Sampling

32. Sample Size Determination • Time/location boundaries • Money! • Statistical Calculation

33. Statistics for Comparison of Means between Two Independent Groups

34. Sample Size Formula For Estimation of Mean (95% confidence) For Comparison of Means (2 independent group; 95% confidence, 80% power)

35. Data Collection Techniques

36. مشاهده • ابزار جمع آوري اطلاعات • فرم جمع آوري اطلاعات • دستگاه اکوکارديوگرافي • دستگاه MRI • کيت هاي آزمايشگاهي • ... • نمونه ها: • پرسش باليني • معاينه ي باليني • اکوکارديوگرافي • اندوسکوپي • بيوپسي

37. استفاده از اطلاعات ثبت شده • ابزار جمع آوري اطلاعات • فرم جمع آوري اطلاعات • پرونده ي پزشکي • گواهي ولادت و فوت • زيج حياتي • ... • نمونه ها • پرونده خواني • استفاده از اطلاعات ثبت شده در بيمه، پزشکي قانوني، مراکز بهداشتي و ... • اسناد قانوني

38. ساير روش هاي جمع آوري اطلاعات • پرسش نامه ي کتبي • مصاحبه ي عميق • بحث متمرکز گروهي • استفاده از افراد ديده بان • ...

39. Validity and Reliability

40. روايي (اعتبار) (Validity) انواع خطاها: • خطاهاي تصادفي (Chance Error) • خطاهاي منظم يا سيستماتيک (Bias)

41. پایایی (Reliability) • تکرار پذیری نتایج (Reproducibility)

42. Epidemiologic Association

43. Is the Association ‘REAL’ ? Defining the errors

44. Types of errors • Random (Chance) errors • Sample size • Systematic errors (BIAS) • Selection bias OCP & DM, Hospital control, loss to F/U • Information bias Recall bias

45. the Association ‘isREAL’ Is the association CASUAL?

46. Causal Associations cause coffee Pancreatic cancer effect

47. Non-Causal Associations : CONFOUNDERS coffee cause smoking confounder Pancreatic cancer effect

48. Work Plan & Budgeting

49. GANTT Chart