L02 Developing Research Questions & Study Plan Flashcards
What are some considerations to ask yourself when conceiving a research question?
What are the important research questions in the field?
From literature review:
- What has been found? What areas need further exploration? What are the research gaps?
- Has a great deal of research already been conducted in the topic area?
- Has such a study been conducted before? If so, is there room for improvement?
Is the timing right for the research question to be answered? Is it a hot topic, or is it becoming obsolete?
Would funding sources & scientific / professional community be interested?
Will the study have a significant impact on the field?
Using the FINER criteria, how does one develop a good research question?
1) Feasible
- Adequate number of subjects
- Adequate technical expertise
- Affordable in time & money
- Manageable in scope
2) Interesting
- Getting answer intrigues investigators, peers & scientific/professional community
3) Novel
- Confirms, refutes or extends previous findings
- Provides new findings
4) Ethical
- Amenable to a study that the institutional review board (IRB) will approve
5) Relevant
- To scientific knowledge
- To clinical & health policy
- To future research
To ensure an adequate number of subjects are recruited for the study, what should investigators do prior to recruitment?
1) Perform preliminary sample size calculation w/ statistical packages or sample size calculators.
2) Enroll / Recruit more than the minimum required sample size to account for potential loss to follow-up subsequently in the study.
3) May sometimes be necessary to conduct a pilot survey or chart review (i.e. looking at medical records) to be sure of adequate sample size / statistical power.
If the number of subjects appears to be insufficient during recruitment, what are some ways investigators can do to ensure sufficient statistical power is achieved?
1) Expand inclusion criteria
2) Eliminate unnecessary exclusion criteria
3) Lengthen time-frame for enrolling subjects
4) Acquire additional sources of subjects by inviting colleagues to join in a multi-centre study w/in or across countries
5) Use a different study design
What are some advantages & disadvantages of developing multiple research questions to be explored in one study?
(+) Efficient as several answers emerge from a single study
(-) Increased complexity of designing & implementing the study
(-) Increased complexity/difficulty in drawing statistical inferences when there are multiple hypotheses
Describe a sensible strategy research studies are recommended to adopt when exploring more than one research question.
1) Establish a SINGLE primary research question around which to focus the study plan & sample size calculations
2) Add secondary research questions about other predictors or outcomes that may produce valuable conclusions
How does an investigator frame a research question?
Using the PICOT approach:
1) Population
- What specific (patient) population are you interested in?
- i.e. inclusion/exclusion criteria
2) Intervention
- What is your investigational intervention?
3) Comparator
- What is the main alternative to compare with the intervention?
- e.g. drug vs placebo, drug A vs drug B etc.
4) Outcome
- What do you intend to accomplish, measure, improve or affect?
5) Time Frame
- What is the appropriate follow-up time to assess outcome?
Identify the PICOT components in the following research question.
In patients without preoperative anemia undergoing cardiac or orthopedic surgery, does treatment with: (1) intravenous iron alone; or (2) intravenous iron with recombinant erythropoietin; compared with (3) placebo administered a day after surgery, increase hemoglobin concentration 7 days after surgery?
P: Patients without preoperative anemia undergoing cardiac or orthopedic surgery
I: (1) intravenous iron alone; or (2) intravenous iron with recombinant erythropoietin
C: compared against placebo
O: Increase in hemoglobin concentration 7 days after surgery
T: 7 days after surgery
Differentiate between ‘research question’, ‘hypothesis’ & ‘study objective’.
1) Research Question:
A well-thought-out focused research question leads directly into the hypothesis via FINER criteria & PICOT approach
- e.g. How does [I] low-intensity pulsed ultrasound (LIPUS) administered for 12 weeks [C] compared with a placebo device in [O] managing knee pain of [P} individuals with patellar tendinopathy?
2) Hypothesis:
A speculative statement that suggests an answer to the research question & MUST be testable (i.e. to reject H0 or not using statistical tests)
- e.g. Pain levels are reduced in individuals who receive daily active-LIPUS (treatment) for 12 weeks compared with individuals who receive inactive-LIPUS (placebo).
3) Study Objective:
Aim the investigator sets out to achieve with the research via primary & secondary objectives.
- To investigate the clinical efficacy of LIPUS in the management of patellar tendinopathy symptoms.
Outline the elements required to form a study plan.
1) Research Question: What question(s) will the study address?
2) Background & Significance: Why are these questions important (based on literature review)?
3) Study Design: How is the study structured?
- Approach & Time frame
4) Subjects: Who are the subjects & how will they be selected?
- Inclusion / Exclusion criteria
- Sampling strategy
5) Variables: What measurements will be made?
- Predictor, outcome & confounder variables
6) Statistical Issues: How large is this study & how will it be analysed?
- Hypotheses
- Sample size
- Analytical approach
What does the typical structure of a one-page research proposal look like?
1) Title of research study
2) Introduction / Background information of study
3) Research hypothesis
4) Research objective
5) Methods
6) Impact of the study
7) Relevant references
