Clinical Research Amid
the Chaos of a Busy
Clinical Practice
Rebecca C. Britt MD
Assistant Professor
Department of Surgery
Eastern Virginia Medical School
Clinical research
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can do it!!!!!
4 issues:
Generate a question
n Access the data
n Analyze the results
n Present and publish
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Generating the question
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Frequently, the best questions come from
interesting patients, routine discussion on
rounds, or papers you are reading.
Find a topic that is interesting, and begin with a
literature search to see what else has been
published on that area. Does this agree or
disagree with your bias and personal experience?
Generating the question
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Don’t be afraid to question something that is
“routine practice” or “standard of care”,
especially if there is no real data in the literature
to support it!
There are great research opportunities in
analyzing the various training methods we are
currently using, many of which have not yet
been proven. Consider the educational activities
you are involved in when generating a question.
Generating the question
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Discuss the questions you have in mind with
your peers. Do they agree or disagree with your
bias? Brainstorm with colleagues to further
refine your question.
Don’t make the initial question too broad or
multi-faceted. Realize that one question will lead
to another and another, etc…..all of which will
make good studies.
Narrow the question down to a hypothesis.
Access the data
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This is the most difficult part !
Decide what type of study is necessary to answer the
question. Options include survey, retrospective,
prospective, etc.
You need to be aware of your resources. Does your
department have databases? What national databases
are available, and how do you gain access?
If you do not currently have databases, strongly
consider starting them with your study data!
ICU Data Initial 24h
Name _____________________ MR ____________
Date of Admission ________
Age ____ Height ______ Weight _______
PmHx __________________________________________________________________
Diagnosis: ______________________________________________________________
Operations: ______________________________________________________________
Apache II _______
ER Labs: ABG __________________ Lactate _____ Wbc _____ H/H _______
Platelets _____ Na ____ K ____ Cl ____ Co2 _____ BUN ______ Crt _____ Glu _____
Etoh _____CPK _____
CV: MAP low ______ MAP high ______ HR low _____ HR high _____
CO ____ CI ____ SVRI ____ PVRI ____ PCWP _____SVO2 _____
Pulm: Airway type ______ RR ______
Vent Settings: Mode ______ Rate ______ TV ______ FIO2 ______ PS _____ Peep ____ Paw _____
ABG _________________
FEN: In _______ / Out _______
GI: Diet ___________ Feeding tube: gastric / SB
Formula ___________
TF rate _______ TF goal ______ Abdominal Compartment Pressure _______________
ID: T max _____ Infections? _______________________________________________
Micro __________________________________________________________________
C dif ? Y / N
Heme: Transfusion Y/N Type/ volume _______________________________
DVT prophylaxis Y / N Type? _________
Labs: Lactate _____ Wbc _____ H/H _______ Platelets _____ Na ____ K ____
Cl ____ Co2 _____ BUN ______ Crt _____ Glu _____ INR ______ PTT _______
Prealbumin ________ CRP ________ Cortisol _________
Medications:
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
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ICU Daily Database
Medical record _______________
Hospital day ______
Operations last 24h _______________________________________________________
24 hour events ___________________________________________________________
CV: MAP low ______ MAP high ______ HR low _____ HR high _____
CO ____ CI ____ SVRI ____ PVRI ____ PCWP _____SVO2 _____
Pulm: Airway type ______ RR ______
Vent Settings: Mode ______ Rate ______ TV ______ FIO2 ______ PS _____ Peep ____ Paw _____
ABG _________________
FEN: In _______ / Out _______
GI: Diet ___________ Feeding tube: gastric / SB
Formula ___________
TF rate _______ TF goal ______ Abdominal Compartment Pressure _______________
ID: T max _____ Infections? _______________________________________________
Micro __________________________________________________________________
C dif ? Y / N
Heme: Transfusion Y/N Type/ volume _______________________________
DVT prophylaxis Y / N Type? _________
Labs: Lactate _____
Wbc _____ H/H _______ Platelets _____ Na ____ K ____
Cl ____ Co2 _____ BUN ______ Crt _____ Glu _____ INR ______ PTT _______
Prealbumin ________ CRP ________ Cortisol _________
Medications:
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_________
Access the data
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What resources exist to help you gather the data.
This is especially crucial if you are doing
retrospective chart review, which can be very
frustruating
Medical students and residents can be an
excellent resource here.
Does the department have research nurses? Are
they willing to help gather the data?
Access the data
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Create a data collection tool that is broad
enough to generate many data points for you.
Consider any data that may be important on
your initial tool to prevent you from needing to
return to the data source a second or third time
down the road.
Analyze the results
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Enter the data from your data collection tool
into Excel or equivalent spreadsheet.
Microsoft Excel is excellent because it is user
friendly, well organized, and has statistical
programs that are easy to use built-in.
Microsoft Access is great for database because it
can hold more data and is more sophisticated
for complex entry and analysis.
Analyze the results
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Determine what type of statistical analysis
applies. Do you need a statistician, and what are
the department resources for such? If the
analysis is less complex, many basic statistical
packages exist that are user-friendly.
Present and Publish
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Submit the work to a local, regional, or national
meeting.
Determine appropriate forum based on size of
study, area of interest, and advice from mentors.
State and regional meetings are excellent forums
for junior researchers to learn to present and
gain confidence.
Present and Publish
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Always write the paper prior to presenting at the
meeting, because you will find that your enthusiasm for
that particular project will wane once the presentation is
completed.
Use the questions generated at the presentation to
modify the paper, or to initiate a new spin-off project.
Don’t loose faith if the initial submission is not
accepted. Continue to submit to a different forum.
Pearls
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Finding time to do clinical research in the midst
of a busy practice can be tough. If you know
your resources and are able to use them, this will
help you inordinately!
Pick projects about which you have a strong
passion. This will help maintain your interest.
Pearls
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Create projects out of activities that you are
already involved in, such as teaching simulation
or curriculum design.
Monitor clinical interventions or changes in
practice within the clinical milieu, and report on
the outcomes. Again, this is likely something you
are already going to be doing, so it is easy to
follow.