Research Planning Identify knowledge gap to select and to justify the research problem. Transform the problem into clear researchable aims and research question (formulate the research question). 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 on researchers asking the „right‟ questions and identifying solvable 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 clinical practice: 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, and outcome?3. What is the best feasible study type?
What is the question?TASK Think of some of the clinical questions you have asked recently. Write one of these questions down in your own words…
Example“What is the role of antibiotics in people who get recurrent skin infections”
Example “What is the role of antibiotics in people who get recurrent skin infections” What is wrong with the way we expressed our question? Too board, not specific. Not clear what information is needed. Unanswerable.
• To formulate an answerable question we first need to think . . . . . . . • 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 electronic textbooks
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 recurrent skin infections” “In people with recurrent skin infections do prophylactic antibiotics 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 the problem.• 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 exposure that we are interested in.
What is the problem, intervention, comparator, and outcome? Population In patients with recurrent skin infection Indicator (intervention, test, etc) Do prophylactic antibiotics Comparator Compared with no treatment Outcome Reduce recurrence rates
The Finer criteria for a good research question accredited to students1. 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 in the past. “Bread-and-Butter”2. Experimental studies (Interventional Studies) Researcher actively attempts to change something to alter the disease course.
Observational Studies1. Descriptive studies: Describes the occurrence of disease and exposure. Most commonly used Look for patterns of disease, to measure the occurrence of disease, 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 without disease, between people with or without exposures thought to cause disease. 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 for outcome 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 Studies Advantages Disadvantages1. May study several 1. Does not establish outcomes and exposure sequence of events.2. Short Duration 2. Survivor bias3. Good first step 3. Not feasible for rare4. Yield prevalence and conditions relative association 4. Does not yield incidence.5. Inexpensive
Cohort Studies• Study in which people, who are free of the disease of interest (outcome) but differ on a certain exposure (study factor), are followed and the incidence of disease measured.• Follow – up Studies: follow people over time to see what happen to them• Included participants must be free of the outcome of interest.• Mostly Prospective study
Cohort Studies Advantages Disadvantages1. The exposure has 1. Not efficient for rare definitely preceded the diseases. outcome (causal 2. Expensive association). 3. Need long time2. Establish Incidence3. Multiple outcomes4. Other factors can be measured
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 interest and a comparison group without the disease (controls, reference group), and the measure their past exposure to certain risk factors.• Retrospective Study
Case-Control Studies Advantages Disadvantages1. Ideal for rare cases 1. Limited to one outcome variable.2. Short duration 2. Selection bias (cases or controls)3. Inexpensive 3. Does not establish a sequence of4. Small subjects are event required. 4. Measurement bias 1. recall bias 2. Interviewer bias 5. Survival bias
Intervention studies or experiments• A study in which the investigator intentionally alters one or more factors under controlled conditions in order to study the effect of doing so.• Includes: • Randomized Controlled (clinical) trials (RCTs) • Preventive Trials • Community Trials