Clinical Research Amid the Chaos of a Busy Clinical Practice

1. Clinical Research Amid the Chaos of a Busy Clinical Practice Rebecca C. Britt MD Assistant Professor Department of Surgery Eastern Virginia Medical School

2. Clinical research • You can do it!!!!! • 4 issues: • Generate a question • Access the data • Analyze the results • Present and publish

3. Generating the question • 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?

4. Generating the question • 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.

5. Generating the question • 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.

6. Access the data • 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!

7. 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: _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

8. 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: ___________________________________________________________________________________________________________________________________________________________________________________________________

9. Access the data • 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?

10. Access the data • 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.

11. Analyze the results • 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.

12. Analyze the results • 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.

13. Present and Publish • 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.

14. Present and Publish • 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.

15. Pearls • 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.

16. Pearls • 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.