Research Planning Identify knowledge gap to select and to justify theresearch problem. Transform the problem into clear researchable aimsand research question (formulate the researchquestion). Search for existing information. Focus the research question Design the study.
The Research Process You begin with an observation Generate explanations or “Theories” Make Predictions “Hypothesis” Data processing Identify Variables Collect data Data Analysis Data Presentation
Sources of Research Questions• Health development and promotion depends onresearchers asking the „right‟ questions and identifyingsolvable problems.• Sources:• Expertise of researchers (professional background):• Theoretical knowledge• Practical experience• Culmination of intensive preliminary observations• Reading in the library• Discussion
Where do questions come from?1. From patient-centered questions in routine clinicalpractice: Diagnosis Etiology Prognosis Treatment or prevention2. From new treatment or diagnostic tests.3. From physician and patient experiences.
Defining a good question• Importance• Interest• Motivation• Innovation• Ethical considerations• Answerability• Type III error: Asking the wrong question• Type IV error: Asking a question not worth answering
Formulate an answerable question1. What is the question? Variance questions: Focuses on difference and correlation(Quantitative, Clinical) Process questions: Focuses on how and why things happen(Qualitative)2. What is the problem, intervention, comparator, andoutcome?3. What is the best feasible study type?
What is the question?TASK Think of some of the clinical questions you have askedrecently. Write one of these questions down in your ownwords…
Example“What is the role of antibiotics in people who get recurrentskin infections”
Example “What is the role of antibiotics in people who getrecurrent skin infections” What is wrong with the way we expressed ourquestion? Too board, not specific. Not clear what information is needed. Unanswerable.
• To formulate an answerable question we first need tothink . . . . . . .• What do we really want to know?• What type of question are we asking?• Does our question concern background or foreground information?
Background questions• Questions concerning basic biological processes.• e.g. What is . . . . .? How does . . . . .?• Best information source: regularly updated electronictextbooks
Foreground questions• Generated in the clinical setting• Specific and relevant to clinical decision making• Observational? Frequency? Diagnosis? Aetiology?Prognosis? Or Intervention?
“What is the role of antibiotics in people who get recurrentskin infections”“In people with recurrent skin infections do prophylacticantibiotics reduce recurrence rates”• Foreground question• Intervention
What is the problem, intervention, comparator,and outcome?• Problem/Population:• Who are the relevant patients/population group and what is theproblem.• Intervention or exposures and comparator:• What are the treatment / exposure being considered?• What is the comparator?• Outcome:• What are the person-relevant consequences of the exposurethat we are interested in.
What is the problem, intervention, comparator,and outcome? PopulationIn patients with recurrent skin infection Indicator (intervention, test, etc)Do prophylactic antibiotics ComparatorCompared with no treatment OutcomeReduce recurrence rates
The Finer criteria for a good research question1. Feasible Adequate number of patients, adequate expertise and resources. Affordable in time and money. Manageable in scope.2. Interesting to the investigator3. Novel Provides new findings Extends previous findings Confirms previous findings4. Ethical5. Relevant To scientific knowledge To clinical and health policy To future research directions
Types of Study1. Observational studies Researcher has an observational role Researcher does not intervene, leaves nature takes its course Researcher role is to record what happens or what happened inthe past. “Bread-and-Butter”2. Experimental studies (Interventional Studies) Researcher actively attempts to change something to alter thedisease course.
Observational Studies1. Descriptive studies: Describes the occurrence of disease and exposure. Most commonly used Look for patterns of disease, to measure the occurrence ofdisease, to identify risk factors for disease Concerned with the „person, place, and time‟ Questions “Who? What? Where? and When? (Not Why?) Includes:○ Case Reports○ Case Series
Observational Studies1. Analytical studies: Incorporate analysis of association between exposure and disease. Involve planned comparisons between people with and withoutdisease, between people with or without exposures thought to causedisease. Try to answer question “Why” Includes:○ Cohort Studies (follow-up Studies).○ Case-Control Studies.○ Cross-sectional Studies.○ Ecological Studies.
Cross-sectional Studies• Sample of the subjects in a population are investigated foroutcome and/or exposure.• Used as a first step in more complex design• Simple description of disease prevalence (blood pressure,height, DM)• Known as: Prevalence Studies
Cross-sectional StudiesAdvantages1. May study severaloutcomes and exposure2. Short Duration3. Good first step4. Yield prevalence andrelative association5. InexpensiveDisadvantages1. Does not establishsequence of events.2. Survivor bias3. Not feasible for rareconditions4. Does not yield incidence.
Cohort Studies• Study in which people, who are free of the disease of interest(outcome) but differ on a certain exposure (study factor), arefollowed and the incidence of disease measured.• Follow – up Studies: follow people over time to see whathappen to them• Included participants must be free of the outcome of interest.• Mostly Prospective study
Cohort StudiesAdvantages1. The exposure hasdefinitely preceded theoutcome (causalassociation).2. Establish Incidence3. Multiple outcomes4. Other factors can bemeasuredDisadvantages1. Not efficient for rarediseases.2. Expensive3. Need long time
Case-Control Studies• The subjects are defined or selected by disease status(outcome) not by exposure status.• Choose individuals with the disease or outcome of interestand a comparison group without the disease (controls,reference group), and the measure their past exposure tocertain risk factors.• Retrospective Study
Case-Control StudiesAdvantages1. Ideal for rare cases2. Short duration3. Inexpensive4. Small subjects arerequired.Disadvantages1. Limited to one outcome variable.2. Selection bias (cases or controls)3. Does not establish a sequence ofevent4. Measurement bias1. recall bias2. Interviewer bias5. Survival bias
Intervention studies or experiments• A study in which the investigator intentionally alters one ormore factors under controlled conditions in order to study theeffect of doing so.• Includes:• Randomized Controlled (clinical) trials (RCTs)• Preventive Trials• Community Trials