Developing Research Questions and Study Plan

Question 1

What is the FINER criteria?

Answer 1

F - feasible 
I - interesting 
N - novel 
E - ethical 
R - relevant

Question 2

Feasible

Answer 2

1. Adequate number of subjects
   - Perform a preliminary calculation of the sample size requirements of the study
   » Statistical packages
   » Sample size calculators

• Many studies do not achieve their intended purposes because they cannot enroll enough subjects.
  » May sometimes be necessary to conduct a pilot survey or chart review to be sure.
• If the number of subjects appears insufficient:
  » Expand the inclusion criteria
  » Eliminate unnecessary exclusion criteria
  » Lengthen the timeframe for enrolling subjects
  » Acquire additional sources of subjects by inviting colleagues to join in a multi-center study
  » Use a different study design

2. Adequate technical expertise
   - Investigators should have the skills, equipment and experience needed for designing the study, recruiting the subjects, measuring the variables as well as managing and analyzing the data.
   - Invite experienced colleagues to be involved in the study as co-investigators.
3. Affordable in time and money
   - If the projected costs exceed the available funds, consider a less expensive design and identify additional sources of funding.
4. Manageable in scope
   - Problems often arise when attempting to accomplish too much.
   » Narrow the scope of the study
   » Focus only on the most important goals

Question 3

Interesting

Answer 3

• Speak with mentors and outside experts before devoting substantial energy to develop a research plan or grant proposal that peers and funding agencies may consider dull.

Question 4

Novel

Answer 4

• Research question can be:
  » Novel
  » Find out whether a previous observation can be replicated
  » Whether the findings in one population also apply to others
  » Whether improved measurement techniques can clarify the relationship between known risk factors and a disease
• Confirmatory studies are particularly useful if it avoids the weaknesses of previous studies.

Question 5

Ethical

Answer 5

• IRB applications are required for all research studies involving human participants.
• If the study poses unacceptable physical risks or invasion of privacy, the investigator must seek other ways to answer the research question

Question 6

Relevant

Answer 6

• Research question should have the potential to contribute to and extend the scientific body of knowledge.
• When relevance is uncertain, it is useful to discuss the idea with mentors, clinicians or experts in the field.
• A strong research question should always pass the ‘so what?’ test.

Question 7

What does PICOT stand for?

Answer 7

Population - What specific (patient) population are you interested in?

Intervention - What is your investigational intervention?

Comparison - What is the main alternative to compare with the intervention?

Outcome - What do you intend to accomplish, measure, improve or affect?

Timeframe - What is the appropriate follow-up time to assess outcome?

Question 8

Roadmap for determining and framing research questions

Answer 8

Step 1: Identify the research problem or idea
Step 2: Consider options for PICOT element for framing the question
Step 3: Focus the research question
Step 4: Check whether the question follows the FINER criteria

Question 9

What are the things to take note of as one progresses from creating a research question to making a study objective?

Answer 9

Research question:
- A well thought-out focused research question leads directly into the hypothesis (e.g. FINER criteria, PICOT approach)

Hypothesis:
- A hypothesis is a speculative statement that suggests an answer to the research question (must be testable)

Study Objective:
- A study objective is the aim that the investigator sets out to achieve with the research (i.e. primary and secondary objectives)

Question 10

What are the elements to take note of when developing a study plan?

Answer 10

1. Research questions: What questions will the study address?
2. Background and significance: Why are these questions important?
3. Design (approach and timeframe): How is the study structured?
4. Subjects (selection (inclusion and exclusion) criteria, sampling strategy): Who are the subjects and how will they be selected?
5. Variables (predictor, outcome and confounding variables): What measurements will be made?
6. Statistical issues (hypothesis, sample size, analytic approach) - how large is the study and how will it be analysed?