Cigarette smoking and lung cancer in women: Results of the French ICAREcase–control study. Lung Cancer 74 (2011) 369– 377 The effects of waterpipe tobacco smoking onhealth outcomes: a systematic review.International Journal of Epidemiology 2010;39:834–857 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.
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
How to write a research proposal for observational studies
HOW TO WRITE A RESEARCHPROPOSAL FOROBSERVATIONAL STUDIES?WORKSHOP
Objective To illustrate a guide to writing a researchproposal, outlining the important elements of aresearch proposal for observational studies.
„Title‟Example:Does shisha smoking cause lungcancer? A prospectiveMulticentre, observational study
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 topublic health What is the purpose of the study? (researchquestion)
Elements of research proposal1. WHY?Study Objectives Primary objective(sample size depends on this) Secondary objectivesHypothesis
Example of Introduction1. The Intro beginsbroadly…..2a. More specific…. Lung cancer is the leading cause of cancer death, andis associated with low 5 year survival rates ifdiagnosis late. In 2005, the age-standardisedincidence rate of female lung cancer in France was12.6, with a 5.1% annual increase . Whileincidence is still higher among men,……….……burden of the diseases Early epidemiologic studies demonstrated thatcigarette smoking is a major cause of lung cancer.Tobacco smoking using the traditional forms oftobacco (waterpipe , arguileh, hookah and shisha) isan older form of tobacco consumption in the easternMediterranean region ….……..rationale ofexposure
Example of Introduction2b. Even more so.... Data from low quality studies showed thatwaterpipe tobacco smoking is possibly associatedwith a number of deleterious health outcomesincluding lung cancer  …….. ….citelandmark research/reviews here tomake key points However, there is paucity of high-quality studies toidentify the strength of association between shishasmoking and risk for developing lung cancer.........cite research gap/need forstudy ….. problemstatement/importance of issue
Example of Introduction3. Until you introduceyour study….. In this study, we examine the association betweenshisha smoking and lung cancer in a large prospectivestudy……..include study’s uniquecontributionhere/objectives/research question
Example of Objectives Primary objective: To examine the associationbetween Shisha (or equivalents) smoking and risk ofdeveloping lung cancer Secondary objectives: To estimate the magnitude of association relative tointensity, total duration of Shisha /equivalents smoking,times-week; after adjusting for all potential confounders. To estimate the magnitude of association relative to thetype of smoke used; after adjusting for all potentialconfounders.
Example of Hypothesis We hypothesize that shisha smoking is associatedwith increased risk of developing lung cancer.OR We hypothesize that the risk of lung cancerincreases with increased intensity (or duration) ofshisha/equivalents smoking.
Methods“The methods or procedures section is really theheart of the research proposal. The activitiesshould be described with as much detail aspossible, and the continuity between themshould be apparent”(Wiersma, 1995, p. 409).
Methods HOW?1. Study Design“Describe the research methods that could be used for the bestachievement of the study objectives and testing yourhypothesis” Study area Type of study Design architecture (flow-chart) Instruments for data collection (questionnaire, observationrecording form, etc.) Include in appendix Endpoint (in prospective studies) Outline of study procedure (in observational studies)
Outline of study procedure TemplateActivity TimeVisit 1 Visit 2 Visit 3 Visit 4 Visit 5Activity TimeVisit 1 Visit 2 Visit 3 Visit 4 Visit 5ConsentBlood test XCT chestPulmonary functionExample
Methods HOW?2. Participant Selection (sampling)“Mention the sampling technique that will be used in orderto obtain a representative sample for your targetpopulation” Recruitment and Enrolment (multicentre, singlecentre....etc) Study population (including sampling technique) Study participants Case definition Inclusion/Exclusion Criteria for cases Inclusion/Exclusion Criteria for controls
Methods WHAT?Conduct of Study What is the exposure What is/are the outcome(s) Key variables Detailed study procedure What variables are to be measured Development of lungcancer
Methods WHAT?Evaluation of the outcomesTools (lab, radiology,.......etc)Management of Patient Care (in prospective studies)Protocol deviation and subject withdrawal (inprospective studies)
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)
Work plan Timelines starting time duration of the study duration for each participantTask Month1 2 3 4 5 6 7 8Progress report
Utilization and dissemination ofthe results SO WHAT? What will this study add to the existing knowledge?‘how this research will refine, revise, or extend existingknowledge in the area to be investigated’ Will the study results be generalized?
Adds onSTUDY MONITORING (in prospective studies)ETICAL CONSIDERATIONS (consents, invitation letters)BUDJECT AND RESOURCES Personnel Equipments Supplies Patients costs Training
Adds onLIMITATIONS‘Indicate any potential weakness in the study, analysis,your instruments, the sample’REFERENCES‘Mention recent articles relevant to the study subject andenumerated according to their order of appearance inthe text’APPENDIXES