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1. Why is the research question important? A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.
2. Why is the research question important? A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.
3. Why is the research question important? A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.
4. Why is the research question important? A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.
5. Formulating the Research Question David L. Brown, MD
LTC, MC, USA
6. Learning Objectives Discussed the clinical question vs. the research question
Answered the What, Who, When, Where, Why, and How
Converted the research question into a hypothesis Research begins with a clinical question, some information that we need to have in order to better serve our patients.
Once that need for knowledge is identified, we can refine our clinical question into one that is amenable to research.
Finally, this question is framed as a declarative statement that becomes the research hypothesis, which we will test.Research begins with a clinical question, some information that we need to have in order to better serve our patients.
Once that need for knowledge is identified, we can refine our clinical question into one that is amenable to research.
Finally, this question is framed as a declarative statement that becomes the research hypothesis, which we will test.
7. Why is the research question important? It is the foundation of your study
The research question determines
The study design
The subject selection
The methods
The statistical tests A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.A well-written research question is vital because it forms the foundation upon which the entire project is built.
Your refined research question will determine the study design, subjects, methods, and statistics you will use to report your results.
8. Where to start? What clinical questions do you have?
What excites you?
What populations interest you or are available to you?
What would you like to change?
Will it keep your interest? Start with a topic that interests you or a clinical question that you have.
Think about the populations which you encounter daily.
Think about what data you have access to.
What would you like to change about the clinical process?
Your topic should interest you and be able to pass the “Saturday Night Test” (i.e. it interests you enough that you would be willing to work on the project anytime).Start with a topic that interests you or a clinical question that you have.
Think about the populations which you encounter daily.
Think about what data you have access to.
What would you like to change about the clinical process?
Your topic should interest you and be able to pass the “Saturday Night Test” (i.e. it interests you enough that you would be willing to work on the project anytime).
9. The Question! Clinical Question
Initial curiosity
Too broad or vague to be applied to research Research Question
Narrow and specific
Clearly identifies the phenomenon to be studied 1. An essential ingredient in any quality research project is a well-defined research question. The question should be simple and specific - a small, clearly defined project is always preferable to one that is large and vague.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
In contrast to the clinical question, the research question:
Applies to a specific group of patients
Is narrowed down to one uncertainty
Is amenable to research methods
Additionally, a well written research question is constructed to answer an important question and NOT to confirm the beliefs or prejudices of the researcher (in other words, it is free from bias).1. An essential ingredient in any quality research project is a well-defined research question. The question should be simple and specific - a small, clearly defined project is always preferable to one that is large and vague.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
In contrast to the clinical question, the research question:
Applies to a specific group of patients
Is narrowed down to one uncertainty
Is amenable to research methods
Additionally, a well written research question is constructed to answer an important question and NOT to confirm the beliefs or prejudices of the researcher (in other words, it is free from bias).
10. The Clinical Question Let’s start with a patient who comes into her physician’s office here at MAMC.
The nurse who is checking in a 45-year-old patient for her appointment notes that the patient has not had a Pap smear for the past 4 years and has never had a mammogram.
This causes the nurse to wonder “How many other patients are we missing?”
Based on this encounter, our clinical question is:
How well do we at Madigan Army Medical Center (MAMC) do at obtaining screening tests?Let’s start with a patient who comes into her physician’s office here at MAMC.
The nurse who is checking in a 45-year-old patient for her appointment notes that the patient has not had a Pap smear for the past 4 years and has never had a mammogram.
This causes the nurse to wonder “How many other patients are we missing?”
Based on this encounter, our clinical question is:
How well do we at Madigan Army Medical Center (MAMC) do at obtaining screening tests?
11. Worksheet Activity What is your clinical question?
Write a clinical question that interests you
Discuss your question with a partner
12. Search the Literature Discover what has already been done
Helps define & refine the topic
Updates your knowledge
Not random … need a plan!
Ask for help! 2. The next step is to learn as much as you can about what others have done (literature search and review). A good literature review lets you find out what is out there, helps you define your research topic, updates your knowledge about the subject in which you are interested (makes you an "expert" in that area), and may give you methodological tools to use in your study. To get the most out of your search, you need an effective plan. A medical librarian has the expertise to help you with your search.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Once you have an idea for your research study, the next step is to hit the library and search the literature.
This is a crucial step…
Helps you further define and refine your question
Reveals what work has already been (or not been) done concerning your question
You need to have a plan in order to proceed in an efficient, effective manner.
Don’t be afraid to ask for help. The medical librarian can be a great resource.2. The next step is to learn as much as you can about what others have done (literature search and review). A good literature review lets you find out what is out there, helps you define your research topic, updates your knowledge about the subject in which you are interested (makes you an "expert" in that area), and may give you methodological tools to use in your study. To get the most out of your search, you need an effective plan. A medical librarian has the expertise to help you with your search.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Once you have an idea for your research study, the next step is to hit the library and search the literature.
This is a crucial step…
Helps you further define and refine your question
Reveals what work has already been (or not been) done concerning your question
You need to have a plan in order to proceed in an efficient, effective manner.
Don’t be afraid to ask for help. The medical librarian can be a great resource.
13. Items to Consider What?
Who?
When?
Where?
Why?
How?
4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Here are several questions we need to ask in order to refine our research question: Who, what, where, when, and how?
Additionally, we must most importantly consider “Why?”
Why do I care about this question? Why would other people care?
Would this study impact a large population? What would be a meaningful outcome?4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Here are several questions we need to ask in order to refine our research question: Who, what, where, when, and how?
Additionally, we must most importantly consider “Why?”
Why do I care about this question? Why would other people care?
Would this study impact a large population? What would be a meaningful outcome?
14. Questions to Consider What intervention will be made?
Who will be studied?
When will the study take place?
Where will the study take place?
Why do I care about this question?
How will I evaluate the results? 4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Here are several questions we need to ask in order to refine our research question: Who, what, where, when, and how?
Additionally, we must most importantly consider “Why?”
Why do I care about this question? Why would other people care?
Would this study impact a large population? What would be a meaningful outcome?4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Here are several questions we need to ask in order to refine our research question: Who, what, where, when, and how?
Additionally, we must most importantly consider “Why?”
Why do I care about this question? Why would other people care?
Would this study impact a large population? What would be a meaningful outcome?
15. FINER Criteria Feasible
Interesting
Novel
Ethical
Relevant 3. Based upon your literature search, evaluate your initial question and answer the following questions:
Who cares about the answer?
Is the question applicable based upon what is already shown in the literature?
What is the current opinion about your topic? Is there a consensus, or is opinion divided?
How important is it to have the right answer?
Is the question you are asking unique, or has it been "beaten to death" already in the literature?
What are the implications of various possible answers?
Write a paragraph to justify your study - consider the above questions, but feel free to modify or add to them.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
“FINER” is a memory aid that identifies 5 criteria that should be considered when developing a research question:3. Based upon your literature search, evaluate your initial question and answer the following questions:
Who cares about the answer?
Is the question applicable based upon what is already shown in the literature?
What is the current opinion about your topic? Is there a consensus, or is opinion divided?
How important is it to have the right answer?
Is the question you are asking unique, or has it been "beaten to death" already in the literature?
What are the implications of various possible answers?
Write a paragraph to justify your study - consider the above questions, but feel free to modify or add to them.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
“FINER” is a memory aid that identifies 5 criteria that should be considered when developing a research question:
16. Feasible Enough subjects
Technical expertise
Time and money
Manageable FeasibilityFeasibility
17. Interesting to… You as the Investigator
Your boss
Your peers
Funding agencies InterestInterest
18. Novel Explore new information
Confirm/refute previous findings
Extend results NoveltyNovelty
19. Ethical Physical risks
Invasion of privacy
When in doubt, seek guidance! EthicalnessEthicalness
20. Relevant Advance knowledge
Impact health policy & clinical management
Guide future research RelevanceRelevance
21. Tightening the Focus 4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Now we will take our first shot at changing our clinical question into a research question.
What are some ways we do this?
First, rather than consider all screening tests, we can pick just one that we will study.
Then our question then becomes:
“What is the screening rate for Pap tests at MAMC?”4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Now we will take our first shot at changing our clinical question into a research question.
What are some ways we do this?
First, rather than consider all screening tests, we can pick just one that we will study.
Then our question then becomes:
“What is the screening rate for Pap tests at MAMC?”
22. Define the Population 4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Next, let’s specify our population of interest.
What criteria might we considering in defining our study population?
Our literature search can help us here. In doing the lit search, we discovered that the USPSTF (strongly) recommends screening women for cervical cancer by using cervical cytology (Pap smears). It recommends screening every 3 years starting within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years and continuing until age 65.
We also have to pick a population that will be accessible to us.
Gender
Age
Site of primary health care
Thus, our study population includes women age 21-65 who are eligible for care at MAMC.4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Next, let’s specify our population of interest.
What criteria might we considering in defining our study population?
Our literature search can help us here. In doing the lit search, we discovered that the USPSTF (strongly) recommends screening women for cervical cancer by using cervical cytology (Pap smears). It recommends screening every 3 years starting within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years and continuing until age 65.
We also have to pick a population that will be accessible to us.
Gender
Age
Site of primary health care
Thus, our study population includes women age 21-65 who are eligible for care at MAMC.
23. Define the Time Period 4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Now we want to think about the time period of interest to us.
The USPSTF recommends that Pap smear screening occur every three years.
Therefore, we need to be sure that the population we study was actually at MAMC long enough to have received their screening test within that recommended window:
Assigned to MAMC for the preceding 3 years4. Relook at your original research question - it is time to refine it based upon what you have found out from the literature review.
Define the Population to be Studied
Define the Period of Time for the Study
Select the Variables to be Measured
Change Nonspecific Variables Into Specific Variables That Can be Measured ("Operationalize Your Variables")
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
Now we want to think about the time period of interest to us.
The USPSTF recommends that Pap smear screening occur every three years.
Therefore, we need to be sure that the population we study was actually at MAMC long enough to have received their screening test within that recommended window:
Assigned to MAMC for the preceding 3 years
24. Does this matter? Using the FINER criteria, does this study matter?
Why am I spending all of this time and effort on PAP smears?
25. Think About Statistics 5. This is the appropriate time to see if you have the resources needed to successfully complete the research project:
Estimate the Resources Required to Measure Each of the Variables Mentioned in #4
Estimate the Feasibility of Conducting Your Study by Comparing the Resources Needed With Those Available To You
Based upon the resources that will be required and those you have available, is the research feasible? If not, consider doing a multicenter study and asking others to help out. If it is feasible, then go on.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
So we want to determine the percentage of women in our study population that had a pap smear done during the 3 year period of interest.
What do we want to do with that number?
We could compare it with other populations.
We could compare it to an accepted standard.
We could compare it to a goal.
Whatever we want to compare it to, that comparison will involve the use of statistical testing in order to determine whether our measured number is statistically different than the number we are comparing it to.
The specifics of statistics will be covered in a later presentation, but for now we want to ensure that we write our research question in a way that will allow us to apply statistical tests.5. This is the appropriate time to see if you have the resources needed to successfully complete the research project:
Estimate the Resources Required to Measure Each of the Variables Mentioned in #4
Estimate the Feasibility of Conducting Your Study by Comparing the Resources Needed With Those Available To You
Based upon the resources that will be required and those you have available, is the research feasible? If not, consider doing a multicenter study and asking others to help out. If it is feasible, then go on.
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
So we want to determine the percentage of women in our study population that had a pap smear done during the 3 year period of interest.
What do we want to do with that number?
We could compare it with other populations.
We could compare it to an accepted standard.
We could compare it to a goal.
Whatever we want to compare it to, that comparison will involve the use of statistical testing in order to determine whether our measured number is statistically different than the number we are comparing it to.
The specifics of statistics will be covered in a later presentation, but for now we want to ensure that we write our research question in a way that will allow us to apply statistical tests.
26. The Research Question 6. Restate the Research Question in a Refined Form that Can Be Studied With Available Resources
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
We decide that we want to compare the rate of Pap smear testing in our study population to the rate of 90% set in the goals of Healthy People 2010.
This is our research question. It includes a well-defined population, a specific uncertainty, and a measurable outcome that can be compared to other populations or standards.
The last step before we can get into the specifics of study design and statistical testing is to convert the research question into a research hypothesis.6. Restate the Research Question in a Refined Form that Can Be Studied With Available Resources
(Michael J. Gordon, PhD, William F. Miser, MD and the Madigan Faculty Development Fellows. The "Every Doc Can Do Research" Workbook. http://www.usafp.org/Word_PDF_Files/Every-Doc-Can-Do-Research.doc)
We decide that we want to compare the rate of Pap smear testing in our study population to the rate of 90% set in the goals of Healthy People 2010.
This is our research question. It includes a well-defined population, a specific uncertainty, and a measurable outcome that can be compared to other populations or standards.
The last step before we can get into the specifics of study design and statistical testing is to convert the research question into a research hypothesis.
27. Worksheet Activity What is your research question?
Take your clinical question
Restate as research question
Use what, who, when, where, why, how
Discuss your question with a new partner
28. Research Hypothesis Clearly identifies the variables
Predicts how variables are related
Specifies the study population
Subject to empirical study through collection and analysis of data
29. Research Hypothesis In this case, we choose to take our research question and predict that:
The screening rate for Pap tests in women age 21-65 who were eligible for care and assigned to MAMC for the preceding 3 years will meet or exceed the goals of Healthy People 2010.
This meets the 4 research hypothesis requirements:
Clearly identifies the variables
Predicts how variables are related
Specifies the study population
Subject to empirical study through collection and analysis of data
In this case, we choose to take our research question and predict that:
The screening rate for Pap tests in women age 21-65 who were eligible for care and assigned to MAMC for the preceding 3 years will meet or exceed the goals of Healthy People 2010.
This meets the 4 research hypothesis requirements:
Clearly identifies the variables
Predicts how variables are related
Specifies the study population
Subject to empirical study through collection and analysis of data
30. Worksheet Activity What is your research hypothesis?
Modify question to predict the outcome
Discuss your hypothesis at your table
Be prepared to share with the group
31. Beginning and End Reviewing what we’ve done:
We started with a clinical question:
How well do we at Madigan Army Medical Center do at obtaining screening tests on our patients?
By applying the FINER criteria through a series of refining steps we developed our research question:
How does the screening rate for Pap tests in women age 21-65 who were eligible for care and assigned to MAMC for the preceding 3 years compare to the goals of Healthy People 2010?
We finished by converting that research question into a research hypothesis:
The screening rate for Pap tests in women age 21-65 who were eligible for care and assigned to MAMC for the preceding 3 years will meet or exceed goals of Healthy People 2010.
Now we are ready to start with the design of our study.
Keep in mind that this is not a simple linear process.
As you design your study, you are likely to discover that there are some factors that you did not consider when you developed your research hypothesis.
It is very likely that you will have to go back an further refine your research hypothesis even more before you’re done.Reviewing what we’ve done:
We started with a clinical question:
How well do we at Madigan Army Medical Center do at obtaining screening tests on our patients?
By applying the FINER criteria through a series of refining steps we developed our research question:
How does the screening rate for Pap tests in women age 21-65 who were eligible for care and assigned to MAMC for the preceding 3 years compare to the goals of Healthy People 2010?
We finished by converting that research question into a research hypothesis:
The screening rate for Pap tests in women age 21-65 who were eligible for care and assigned to MAMC for the preceding 3 years will meet or exceed goals of Healthy People 2010.
Now we are ready to start with the design of our study.
Keep in mind that this is not a simple linear process.
As you design your study, you are likely to discover that there are some factors that you did not consider when you developed your research hypothesis.
It is very likely that you will have to go back an further refine your research hypothesis even more before you’re done.
32. Share with Compassion
33. Take Home Points Clinical and research questions are different
Refine your question using What, Who, When, Where, Why, How
Convert your question into a hypothesis Research begins with a clinical question, some information that we need to have in order to better serve our patients.
Once that need for knowledge is identified, we can refine our clinical question into one that is amenable to research.
Answer the Who, When, Where, Why, and How
Use the FINER criteria to develop what you will study and answer why are you doing this study
Convert the question into a hypothesisResearch begins with a clinical question, some information that we need to have in order to better serve our patients.
Once that need for knowledge is identified, we can refine our clinical question into one that is amenable to research.
Answer the Who, When, Where, Why, and How
Use the FINER criteria to develop what you will study and answer why are you doing this study
Convert the question into a hypothesis