1. Planning Your Own Research Kevin Schwartzman MD Epi 679 June 16, 2006

2. Why Do Research? To win friends and influence people (and get a fellowship/job/promotion?) To go to conferences in exciting places To address a scientific question To improve the evidence base To inform practice To explore a field/specialty To see if it is an activity you enjoy To develop contacts, mentoring, etc.

3. What Type of Research? Basic science (e.g. mechanisms of disease and/or treatment) Clinical (patient-oriented)-- observational, experimental Systematic reviews, meta-analyses Epidemiologic/public health Medical education Quality assurance

4. The Research Question The most difficult--and fundamental-- part of any project is formulating a suitable question Does the question make sense? Can it be answered? Can it be answered by you and the team?

5. The Research Question Should it be answered? (Is it something colleagues would want to know?) Should it be answered by you? (Is it something you would want to know?)

6. What Scope? Project should reflect reality of your own (and supervisor’s/colleagues’) time lines and availability For residents, might be anywhere from 1-6 months Well suited to chart audits/reviews, use of existing data resources, gathering of simple prospective data or small number of consecutive patient observations Systematic reviews, meta-analyses Decision analyses

7. What Scope? Pilot studies: collection of preliminary data to demonstrate feasibility, generate information for sample size calculations for more definitive work Resident research block not well suited to studies comparing clinical interventions (e.g. clinical trials) Not well suited to studies involving complicated prospective data, longer term followup, or recruitment of highly selected patients

8. Choosing a Supervisor/Team Experience in research, viewed in the context of your own proposed project (can ask for a CV; major research grants listed on Web sites e.g. CIHR; also many Quebec researchers are listed on FRSQ website) Experience with research supervision and mentoring (how did other residents or newcomers fare?) Accessibility, organization Well-defined team or unit is helpful (e.g. statistical support)

9. Choosing a Supervisor/Team (2) Support for your project (e.g. space, computer, technicians, etc.) Willingness to help set up the project e.g. ethics committee, data resources, etc.

10. What is Your Role? Needs to be described explicitly and agreed upon at the outset, whenever you work with supervisor(s) and/or a team You should be given primary responsibility and credit; that is, your project should “stand alone” with you as first author on presentations and manuscript(s) You should develop a protocol, with appropriate supervision and/or input from others, incorporating all the usual elements: background and literature review, hypotheses/objectives, methods including measurements and analyses

11. Your Role (2) The protocol should be finalized before your research “block,” for clinical trainees Where applicable, your supervisor should ensure that suitable administrative arrangements are made (e.g. ethics committee approval) You and your supervisor/colleagues should be satisfied that your project meets scientific and ethical standards, including requirements for confidentiality

12. Your Role (3) You should expect to take primary responsibility for data collection and management, and to contribute to the analysis This includes appropriate data management You should present your results at scientific meetings You should be responsible for the first draft of any manuscript(s) based primarily on your results You and your team should ensure timely submission of your results

13. Not Your Role To be a research assistant or technician To take primary responsibility for administrative issues e.g. ethics committees, research accounts, grant submissions To take responsibility for data storage, if you are working under supervision

14. Before Your Research Block Literature review and protocol completed (e.g. case/outcome/exposure definitions, inclusions/exclusions) Feasibility addressed, including sample size issues Administrative preparations completed e.g. ethics committee, DPS permission for chart reviews Study materials (questionnaires, chart review forms, databases) prepared

15. Funding Issues Your own time Small-scale expenses—may be covered through funds held by supervisor/team member, or from departmental funds e.g. pulling hospital charts, office supplies Medium-scale e.g. part-time research assistant—as above, plus some specific funding competitions e.g. MUHC pilot projects, FRSQ pilot projects, some specialty societies

16. At the End of the Day... You should have learned about your question You should have learned about the conduct of research You should have learned about writing a research protocol You should have learned about methods of data collection and analysis

17. At the End of the Day…(2) You should have had the opportunity to present and defend your results at scientific meeting(s), local and hopefully national/international You should hopefully have published a manuscript You should have had fun!!!