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Scientific Research

  1. Scientific Research The Fountain of Knowledge Professor Syed Amin Tabish FRCP (London), FRCP (Edin.), FAMS, MD (AIIMS) Postdoc Fellowship, Bristol University (England) Doctorate in Educational Leadership (USA)
  2. Scientific Research  Research conducted for the purpose of contributing towards science by the systematic collection, interpretation and evaluation of data and that, too, in a planned manner is called scientific research It is a systematic collection, analysis and interpretation of data to answer a question or solve a problem
  3. Classification of Scientific Research  According to data collection techniques:  Observational  Experimental  According to causality relationships:  Descriptive  Analytical  According to relationships with time:  Retrospective  Prospective  Cross-sectional
  4. Classification of Scientific Research According to the medium through which they are applied: Clinical Laboratory Social descriptive research
  5. Classification Of Research I. Descriptive research  Case series  Surveillance studies II. Analytical research  Observational studies: cohort, case control and cross- sectional research  Interventional research: quasi-experimental and clinical research
  6. Analytical observational research OBSERVATIONAL  Cohort Studies (Prospective, Retrospective and Ambidirectional)  Case-Control studies  Cross-Sectional studies INTERVENTIONAL RESEARCH (Experimental Studies) 1. Quasi-Experimental Research 2. Clinical Research
  7. Quantitative Research  It is numerical, non-descriptive, applies statistics or mathematics, and uses numbers.  It is an iterative process whereby evidence is evaluated.  The results are often presented in tables and graphs.  It is conclusive.  It investigates the what, where, and when of decision-making.
  8. Qualitative Research  It is non-numerical, descriptive, applies to reason, and uses words.  Its aim is to get the meaning, and feeling and describe the situation.  Qualitative data cannot be graphed.  It is exploratory.  It investigates the why and how of decision- making
  9. Types of Questions Academic “Basic”  To add to our scientific knowledge Applied “Practical”  To solve our practical problems
  10. Research: the Fountain of Knowledge  A research problem refers to a difficulty that a researcher or a scientific community or an industry or a government organization or a society experiences. It may be a theoretical or a practical situation. It calls for a thorough understanding and possible solutions.  Research provides the basis for many government policies. For example, research on the needs and desires of the people and on the availability of revenues to meet the needs helps a government to prepare a budget.  It is the fountain of knowledge and provides guidelines for solving problems.
  11. Step 1. Define a Research Area Areas for research are very broad and overlapping Selection depends on Researcher’s interest Actual need Available resource
  12. 1. RESEARCH AREA Cardiology
  13. Step 2: Select a Research Topic Researcher can not study every topic in the selected area Magnitude of problem Seriousness Preventability Curability Feasibility
  14. 2. RESEACH TOPIC Ischemic Heart Diseases
  15. Step 3. State the Research Objectives?  State objectives at the beginning of study  State them clearly  Objectives are stated in two forms Goal (general objectives) Specific objectives
  16. Research Objectives Should Be  Closely related to research questions  Covering all aspects of the problem  Very specific  Ordered in logical sequence  Achievable (take in account time & resource)  Mutually exclusive (no repetition, no overlaps)  Stated in action verb that can be evaluated
  17. 3. GOAL (GENERAL OBJECTIVES) To contribute to prevention of Ischemic Heart Disease
  18. PRIMARY OBJECTIVES To determine the effect of reducing serum cholesterol (LDL) on the occurrence of MI
  19. SECONDARY OBJECTIVES To describe the side effects of lowering serum cholesterol
  20. Step 4. Develop a Research Question  Before start, you make sure that You has a research question Question is clear and specific Reflect the objective (s) Has no answer by common sense Has no answer in literature Finding an answer will solve the problem of the study
  21. At this stage, review of literature is very important to ensure that research question has no answer
  22. Review of literature is important  Identify valid question  Refine question(s)  Avoid un-needed research  Avoid duplication  Avoid pitfalls of previous studies  Provide scientific background  Give rationale for study
  23. Examples of Questions (1) Description  What is the incidence of disease “D”?  What is the prevalence of disease “D”?  What is the rate of risk factor “F” in the community?
  24. Examples of Questions (2) Etiology  What is the cause of disease “D”?  Is exposure “E” associated with disease “D”?  What is the risk factor “F” associated with the disease “D”?
  25. Examples of Questions (3) Diagnosis  Is test “T1” better than test “T2” in diagnosis disease “D”?  What the value of test “T” in diagnosis disease “D”?
  26. Examples of Questions (4) Therapy  Is drug “A” better than drug “B” in treatment of disease “D”?  Is surgery more effective than conservative treatment for disease “D”?
  27. Examples of Questions (5) Prognosis  What is the five-year survival of patients with disease “D”?  What is the five-year survival of patients having disease “D” after intervention “I”?
  28. 4. RESEARCH QUESTION Does hypo-cholesterolemic agent “A” decrease the risk of MI ?
  29. Step 5: Formulate a Hypothesis It is a statement of research question in a measurable format Hypothesis; must be:  Based on scientific background  Translation of research question  Reflect the study design  Use the study variable  Test only one relationship  Stated in measurable terms
  30. Example for Formulating a Sound Hypothesis A prospective cohort study was designed to answer the research question: “ is hypercholesterolemia (HC) a risk factor for coronary artery disease (CAD)?”
  31. Examine the Following Hypothesis 1. All subjects having HC will develop CAD 2. Dietary habits affect the risk of CAD 3. Rats given high fat diet will develop CAD 4. Atherosclerosis is associated with a high risk of CAD 5. Increased serum cholesterol and triglycerides and decreased HDL lead to increased risk f CAD
  32. 6. CAD is high among hypercholesterolemic subjects 7. Subjects with HC have a higher risk of developing CAD compared to subjects without HC 8. The prevalence of CAD among HC subjects is higher than that in subjects without HC 9. The probability of HC in CAD patients is higher than in subjects without CAD
  33.  Hypothesis (1) is refuted because it is not biologically plausible  Hypothesis (2) is refuted because it is not related to research question  Hypothesis (3) is refuted because it does not reflect the study design (cohort not experiment)  Hypothesis (4) is refuted because it does not use the study variables  Hypothesis (5) is refuted because it examine more than one relationship. It is better to use separate hypothesis for each studied association
  34.  Hypothesis (6) can be refuted because it is not stated in a measurable terms. Expression “high” is very subjective  Hypothesis (8) & (9) an be refuted because they do not reflect the study design. Although they fulfill all other criteria  Hypothesis (7) is a sound hypothesis
  35. 5. RESEARCH HYPOTHESIS Subjects with HC have a higher risk of developing CAD compared to subjects without HC
  36. STUDY DESIGNS  Classification depends on role of investigator in controlling factors under study  Observational  Ecological  Cross sectional  Case control  Cohort  Experimental/interven tion  Lab experiments  Clinical trials  Community interventions  Quasi-experimental
  37. 1. Ecological Study  Sampling units are groups  Good source for new hypothesis  Problems Ecological fallacy Temporal relationship
  38. 2. Cross Sectional Study  Data collected at a single point in time  No control group  Prevalence rate can be calculated  Develop new hypothesis “Snapshot”
  39. Prevalence vs. Incidence  Prevalence The total number of cases at a point in time  Includes both new and old cases  Incidence The number of new cases over time
  40. Example of a Cross-Sectional Study Study of association between garlic consumption & CAD in the Family Practice Clinic
  41. Cross-sectional Study Sample of Population Garlic Eaters Non-Garlic Eaters Prevalence of CAD Prevalence of CAD Time Frame = Present
  42. Cross-sectional Study Garlic Consumption + - C A D + - 90 10 90 10
  43. Cross-Sectional Study  Strengths Quick Cheap  Weaknesses  Weak evidence of association  Lack of representativeness  Absence of temporal relationship  No control of confounders  Prevalence-incidence bias
  44. 3. Case-Control Study  Start with people who have disease  Compare them with controls that do not  Look back and assess exposures
  45. Case-Control Study Patients with CAD Patients w/o CAD Present Past High Garlic Diet High Garlic Diet Low Garlic Diet Low Garlic Diet Cases Controls
  46. Do not eat Eat garlic ill not ill 49 49 98 4 6 10 Presentation of Case-control Study
  47. Strengths  Good for rare outcomes: cancer  Can examine many exposures  Useful to test hypothesis  Fast & easy  Cheap  Provides Odds Ratio  Minimal ethical problems  No risk to participants  No attrition problems
  48. Weaknesses  Cannot measure  Incidence  Prevalence  Relative Risk  High susceptibility to bias Misclassification bias Recall bias Selection bias Confounding bias Temporal relationship
  49. Exposed Unexposed Source population
  50. Cases Exposed Unexposed Source population
  51. Cases Exposed Unexposed Source population Sample
  52. Intuitively If the frequency of exposure is higher among cases than controls Then the incidence rate will probably be higher among exposed than non exposed.
  53. Case Control Study Disease Controls Exposure ? ? Retrospective nature
  54. Marching towards outcomes Cohort Studies
  55. Cohort Study  Begin with disease-free individuals  Classify individuals as exposed/unexposed  Record outcomes in both groups  Compare outcomes using relative risk
  56. follow-up period
  57. Calculate measure of frequency:  Cumulative incidence - Incidence - Attack rate (outbreak) end of follow-up
  58. Unexposed Exposed Cohort Studies
  59. Unexposed Exposed Incidence among exposed Incidence among unexposed Cohort Studies
  60. Example of a Cohort Study To see the effects of smoking on lung cancer development
  61. Prospective Cohort Study Non-smoker Smoker No cancer cancer cancer No cancer Present Future
  62. Smokers Non-smokers ill not ill 70 6930 7000 3 2997 3000 Presentation of Cohort Data
  63. Data Analysis Incidence rate  Among smokers = 70/7000=10/1000  Among non-smoker = 3/3000 = 1/1000 Relative risk = 10/1 = 10
  64. time Exposure Study starts Disease occurrence Prospective Cohort Study Exposure Disease occurrence time Study starts
  65. Retrospective Cohort Study Exposure time Disease occurrence Study starts
  66. Strengths  Provides incidence data  Establishes time sequence for causality  Eliminates recall bias  Suitable for rare exposure  Allows for accurate measurement of exposure variables
  67. Strengths  Can measure multiple outcomes  Can adjust for confounding variables  Can calculate relative risk Dose response can be calculated
  68. Weaknesses  Expensive  Time consuming  Problems of attrition  Cannot study rare outcomes (diseases)  Some ethical problems
  69. Weaknesses  Exposure may change over time  Disease may have a long pre-clinical phase  Change of diagnostic criteria
  70. Experimental Studies Clinical trials provide the “gold standard” of determining the relationship between garlic and cardiovascular disease prevention.
  71. Clinical Trials  Randomized  Double-blind  Placebo-controlled
  72. Clinical Trial Study Population Treatment Group Control Group Outcomes Outcomes R a n d o m i z e
  73. Clinical Trial Study Population R a n d o m i z e Garlic Pill Placebo CAD No CAD CAD No CAD
  74. Strengths  Best measure of causal relationship  Best design for controlling bias  Can measure multiple outcomes
  75. Weaknesses  Ethical issues  Unawareness of patients  Withholding beneficial treatment  Inability to refuse (prisoners)  Potential side effects  Co-intervention & contamination  Feasibility problems
  76. Small Group Tasks  Elect a leader and a speaker  Read your scenario  Design a study to answer the research question  Your funds are not unlimited!  Briefly present your study to the large group  Time:  10 min for study design  10 min for group presentations
  77. Selection of Research Design  Selection of the best research design depends on many factors  Purpose of study  State of existing knowledge  Characteristics of study variables (exposure/outcome)  Latency  Feasibility
  78. Research: The Fountain of Knowledge  A research problem refers to a difficulty that a researcher or a scientific community or an industry or a government organization or a society experiences. It may be a theoretical or a practical situation. It calls for a thorough understanding and possible solutions.  Research provides the basis for many government policies. For example, research on the needs and desires of the people and on the availability of revenues to meet the needs helps a government to prepare a budget.  It is the fountain of knowledge and provides guidelines for solving problems.
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