ACE Curriculum 2015 The research question Iman Sharif, MD, MPH

Objectives To know the criteria for developing a “good” research question FINER criteria PICO question To apply the criteria to the ACE proposals

Format for this session (90 minutes) “Didactic” (30 minutes) Please interrupt/ask questions!! Practice in pairs (30 minutes) Report out and discussion (30 minutes)

Steps for designing a research project 1- Identify a knowledge gap

Steps for designing a research project 1- Identify a knowledge gap 2- Formulate the question

Steps for designing a research project 1- Identify a knowledge gap 2- Formulate the question 3- Search for existing information

Steps for designing a research project 1- Identify a knowledge gap 2- Formulate the question 3- Search for existing information 4- Focus the research question

Steps for designing a research project 1- Identify a knowledge gap 2- Formulate the question 3- Search for existing information 4- Focus the research question 5- Design the study

Steps for designing a research project 1- Identify a knowledge gap 2- Formulate the question 3- Search for existing information 4- Focus the research question 5- Design the study 6- Refine the specific aims and objectives of the study

Steps for designing a research project 1- Identify a knowledge gap 2- Formulate the question 3- Search for existing information 4- Focus the research question 5- Design the study 6- Refine the specific aims and objectives of the study

Quick- write down your questions

Quick- write down your questions Read them out loud (1 at a time please) How did you come up with that question?

Developing a research question F I N E R

Developing a research question F - Feasible I - Interesting N - Novel E - Ethical R - Relevant

FINER Criteria F - Feasible You can get enough subjects to answer the question Power analysis!! You have the technical expertise You have the time and money Manageable in scope

FINER Criteria F - Feasible You can get enough subjects to answer the question Power analysis!! You have the technical expertise You have the time and money Manageable in scope

Focusing the Question Creating an answerable research question P I C O

PICO Question P Population/Patient I Intervention C Comparator O Outcome

PICO Question P Population/Patient Be specific. Age, race, sex, where, socioeconomic status, etc.

PICO Question P Population/Patient Be specific. Age, race, sex, where, socioeconomic status, etc. Quick – tell me the population your ACE proposal addresses

PICO Question I Intervention What exactly do you plan to do? Need to know this, so you know how to compare it to what’s been done Be Specific Who will deliver the intervention What does it involve When will it happen Where will it happen Why (in what situations) will it happen (who qualifies/what triggers?)

PICO Question C Comparator Is there a comparison arm? Pre-post? Subgroups? Known population data? “Usual care” – define specifically just like the intervention For comparative effectiveness research, you may need to defend “usual care” – is it ethical to do nothing? What’s your hypothesis?

PICO Question O Outcome Be Specific How will you measure “better”? S Specific M Measurable A Achievable R Relevant T Time-bound

PICO Question O Outcome Be Specific How will you measure “better”? S Specific 10 point increase in Receptive Vocab M Measurable Peabody Picture Vocabulary Test, III A Achievable literature supports that the R Relevant 10 points means 50% greater high school grad T Time-bound 6 months post intervention

FINER Criteria F - Feasible You can get enough subjects to answer the question Power analysis!! You have the technical expertise You have the time and money Manageable in scope

Developing a research question F - Feasible I - Interesting N - Novel E - Ethical R - Relevant

FINER Criteria I - Interesting To the investigator To stakeholders Why do you care? passion? Problem that you see in your role? Building a career? Builds on mentors work? To stakeholders Community that would be beneficiaries of the research (“patients”/people/youth, etc.) Payers/funders/health care institutions/etc. Industry/Employers Government/Social Service Providers/etc.

FINER Criteria N – Novel Confirms or refutes previous findings Perhaps in a new population… Perhaps in a new environment… Perhaps with a stronger design…. Extends previous findings Provides new findings

FINER Criteria E - Ethical Equipoise (comparing 2 treatments where there is really uncertainty about which is “better”) Does not exclude populations without good reason For example, excluding Spanish-speakers because your research assistant doesn’t speak Spanish Acceptable Risks privacy, harm, debriefing Benefits To research participants/future individuals who are like them

FINER Criteria R - Relevant --- it matters To scientific knowledge To clinical and health policy To future research directions

Relevance/Value of Information in Research 1) probability that the research will produce a useful answer/product; 2) size of the impact on an affected/eligible individual; 3) number of individuals affected; 4) probability/extent to which the research results will actually be disseminated and implemented; 5) duration/lifespan of the benefit

Next 30 minutes Work in pairs Write the research question(s) for your ACE proposal Test the question with the FINER and PICO criteria Time’s up when the bell rings!

Report Out/Discussion F Feasible I Interesting N Novel E Ethical R Relevant P Population/Patient I Intervention C Comparator O Outcome