RSS 2012 How to Write a Research Proposal for Observational Studies

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An excellent in introduction byt Dr Mona Aldabbagh, practical and systematic

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  • A research proposal is a detailed plan of action for scientific inquiry. It clearly and systematically presents the research problem, indicates the significance of the problem, and delineates the specific methods and procedures that will be used to answer the research question or test the research hypotheses. It also provides a timetable or outline for conducting the study and details the estimated cost of the investigation. It is written as a preliminary step in the research process. It synthesizes current knowledge, indicates gaps in knowledge, and specifies a plan to address the problem.
  • To convince others that you have: A good knowledge of the existing work and existing debates and have formulated specific questions which you wish to explore. A research idea which will lead to the creation of new knowledge and understanding.
  • Bot primary and secondary questions should be relevant scientifically, medically and for public health purposes.
  • [1] Cigarette smoking and lung cancer in women: Results of the French ICAREcase–control study. Lung Cancer 74 (2011) 369– 377[2] The effects of waterpipe tobacco smoking onhealth outcomes: a systematic review.International Journal of Epidemiology 2010;39:834–857[3] Int J Epidemiol. 2010 Jun;39(3):834-57.The effects of waterpipe tobacco smoking on health outcomes: a systematic review.
  • State your study design, and describe your data source(s) and data collection methods;
  • Define your study sample – inclusions, exclusions;Sampling is critical to external validity—the extent to which findings of a study can be generalized to people or situations other than those observed in the study.
  • Cases should be carefully defined and specifiedIf age specified, should indicate the
  • Define your key nting and key explanatory variable(s); briefly mention confounders and covariates
  • After presenting the outline for study procedure, and someone had a CT-scan suggestive of lung cancer………. How will the outcome be measured and what tool will be used to measure it….(ie lung biopsy in our case).
  • Describe your analysis plan
  • RSS 2012 How to Write a Research Proposal for Observational Studies

    1. 1. @kaimrc_edu1
    2. 2. HOW TO WRITE A RESEARCHPROPOSAL FOROBSERVATIONAL STUDIES? Mona Al-Dabbagh, MD, MHSc RSS 2012
    3. 3. Objective To illustrate a guide to writing a research proposal, outlining the important elements of a research proposal for observational studies.
    4. 4. What is a research proposal? A detailed plan of action for scientific inquiry  what the researcher intends to do, how, why, where, and whenDr. A. Attar
    5. 5. Why a research proposal? An important documentation of your approach to the research question/objectives Demonstrate scholarly abilities A reference document during execution and also writing up the results of the study Needed document for research committees and funding agencies approvalDr. A. Attar
    6. 6. „Title‟ Example:Does shisha smoking cause lung cancer? A prospectiveMulticentre, observational study
    7. 7. Elements of research proposal1. WHY?Introduction and rationale Literature review of previous studies on the topic  Burden of illness  Biological rationale of intervention/exposure Statement of the problem and its importance to public health What is the purpose of the study? (research question)
    8. 8. What is the question? The primary question should be the one the investigator is most interested in answering and which is capable of being answered. It is the question upon which sample size is calculated Needs special attention to the statistical power (sensitivity) ability to show a difference when it truly is present May be formed in the form of testing a hypothesis
    9. 9. Cont. What is the question? Secondary questions could be of two types: 1. The response variable is different from that of the primary question: Example: Primary question: whether mortality from any cause is altered by the intervention? Secondary question:  Cause-specific mortality rate?  Age specific mortality rate?
    10. 10. Cont. What is the question? 2. Subgroup hypothesis  Example: A study of cancer therapy  looking specifically at the stage of disease  Subgroup hypotheses should be:  Specified before the data are collected  Based on reasonable expectations  Limited in number
    11. 11. Elements of research proposal1. WHY?Study Objectives Primary objective (sample size depends on this) Secondary objectivesHypothesis
    12. 12. Example of Introduction1. The Intro begins  Lung cancer is the leading cause of cancer death, and broadly….. is associated with low 5 year survival rates if diagnosis late. In 2005, the age-standardised incidence rate of female lung cancer in France was 12.6, with a 5.1% annual increase [1]. While incidence is still higher among men,……….…… burden of the diseases2a. More specific….  Early epidemiologic studies demonstrated that cigarette smoking is a major cause of lung cancer. Tobacco smoking using the traditional forms of tobacco (waterpipe , arguileh, hookah and shisha) is an older form of tobacco consumption in the eastern Mediterranean region [2]….……..rationale of exposure
    13. 13. Example of Introduction2b. Even more so....  Data from low quality studies showed that waterpipe tobacco smoking is possibly associated with a number of deleterious health outcomes including lung cancer [3] …….. ….cite landmark research/reviews here to make key points  However, there is paucity of high-quality studies to identify the strength of association between shisha smoking and risk for developing lung cancer .........cite research gap/need for study ….. problem statement/importance of issue
    14. 14. Example of Introduction3. Until you introduce  In this study, we examine the association between your study….. shisha smoking and lung cancer in a large prospective study……..include study’s unique contribution here/objectives/research question
    15. 15. Example of Objectives Primary objective: To examine the association between Shisha (or equivalents) smoking and risk of developing lung cancer Secondary objectives:  To estimate the magnitude of association relative to intensity, total duration of Shisha /equivalents smoking, times-week; after adjusting for all potential confounders.  To estimate the magnitude of association relative to the type of smoke used; after adjusting for all potential confounders.
    16. 16. Example of Hypothesis We hypothesize that shisha smoking is associated with increased risk of developing lung cancer.OR We hypothesize that the risk of lung cancer increases with increased intensity (or duration) of shisha/equivalents smoking.
    17. 17. Methods“The methods or procedures section is really the heart of the research proposal. The activities should be described with as much detail as possible, and the continuity between them should be apparent” (Wiersma, 1995, p. 409).
    18. 18. Methods HOW?1. Study Design“Describe the research methods that could be used for the best achievement of the study objectives and testing your hypothesis” Study area Type of study Design architecture (flow-chart) Instruments for data collection (questionnaire, observation recording form, etc.)  Include in appendix Endpoint (in prospective studies) Outline of study procedure (in observational studies)
    19. 19. Outline of study procedure Template Example Activity Time Visit 1 Visit 2 Visit 3 Visit 4 Visit 5ConsentBlood test XCT chestPulmonary function
    20. 20. Methods HOW?2. Participant Selection (sampling)“Mention the sampling technique that will be used in order to obtain a representative sample for your target population” Recruitment and Enrolment (multicentre, single centre....etc) Study population (including sampling technique) Study participants Case definition Inclusion/Exclusion Criteria for cases Inclusion/Exclusion Criteria for controls
    21. 21. Sampling Study population: a subset of general population defined by the eligibility criteria. Sample: the group of participants actually studied in the study, and who are selected from the general population
    22. 22. How Sampling Works… Imagine a well known picture Since a picture is made up of points of colour (pixels), we will sample the points of colour at different rates. 1% Dr. Mieke Koehoorn, UBC
    23. 23. How Sampling Works… 3% Dr. Mieke Koehoorn, UBC
    24. 24. How Sampling Works… 3% 5% Dr. Mieke Koehoorn, UBC
    25. 25. How Sampling Works… 3% 10% 5% Dr. Mieke Koehoorn, UBC
    26. 26. The way we sample is reflected and corrected by how we weight the data in the end. Dr. Mieke Koehoorn, UBC
    27. 27. Inclusion criteria  Participant should have the benefit form the intervention or at high risk from exposure  Choose people in whom there is high likelihood to detect the hypothesized results of the intervention/ exposure  Weigh the risks/ benefits of the exposure (ethical considerations).  People at high risk of developing conditions that may preclude the ascertainment of the event of interest should be excluded.  Include people who are likely to be compliant.
    28. 28. Methods WHAT?Conduct of Study What is the exposure What is/are the outcome(s) Detailed study procedure What variables are to be measured
    29. 29. Methods WHAT?Evaluation of the outcomesTools (lab, radiology,.......etc)Management of Patient Care (in prospective studies)Protocol deviation and subject withdrawal (in prospective studies)
    30. 30. Methods HOW MANY?Biostatistical Considerations and Data analysis  Sample Size Determination and pow  Outcome Analysis (statistical tests used)  Statistical package(s) usedInterim analysis (in prospective studies)
    31. 31. Work plan Timelines  starting time  duration of the study  duration for each participant Task Month 1 2 3 4 5 6 7 8 Progress report
    32. 32. Utilization and dissemination of the results SO WHAT?  What will this study add to the existing knowledge? ‘how this research will refine, revise, or extend existing knowledge in the area to be investigated’  Will the study results be generalized?
    33. 33. Adds onSTUDY MONITORING (in prospective studies)ETICAL CONSIDERATIONS (consents, invitation letters)BUDJECT AND RESOURCES  Personnel  Equipments  Supplies  Patients costs  Training
    34. 34. Adds onLIMITATIONS‘Indicate any potential weakness in the study, analysis, your instruments, the sample’REFERENCES‘Mention recent articles relevant to the study subject and enumerated according to their order of appearance in the text’APPENDIXES
    35. 35. Thank you

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