Conducting a Directed Study in a Private Practice

1. Conducting a Directed Study in a Private Practice Michael H. Oros CPO Residency Director Scheck and Siress

2. Implementing a Directed Study process in a Private Practice • Selecting a topic • Designing the study • Developing a timeline for completion • Gathering information/materials list • Study assembly • Producing the written document

3. Start the dialogue early! • During the interview process

4. Choosing a topic(8-12 weeks into Residency) Question: What area of the field are you interested in???

5. Choosing a topic(8-12 weeks into Residency) • Prosthetics – Orthotics • Diagnosis vs. Device • People or Materials • Retrospective or Prospective Decision Tree

6. Ownership of the Report Ownership = Commitment Quality of effort Time Spent At home Company time

7. Designing the study(13-20 weeks into the Residency) RULE #1: Know thyself Both Director & Resident: What are the existing clinical/technical/research skill sets?? What are the strengths of the practice?? What support systems are in place to conduct this study??

8. Designing the study(13-20 weeks into the Residency) Directed Study Options: • Literature Review • Case Study w/ Subjects • Scientific Study • Scientific Study w/IRB • Other

9. Designing the study(13-20 weeks into the Residency) Directed Study Options: • Really important to discuss the design limits of the project.

10. Designing the study(13-20 weeks into the Residency) Establish a Budget: • Program pays for misc. expenses: mass mailings, copying documentation, downloadable article reprints etc.) • Small 1 time equipment expenses (i.e. stopwatch) • Fabrication of “test’ devices for patients • Cash for patients participating in trials when necessary • TIME!!! (of both Resident and Staff)

11. Primary Resources Available: • Library • Internet • Patient Records

12. Draft a specific timeline for completion of the project/study(concept to completion) Assemble Materials List Literature Review Data Collection 1st Draft of Paper Submission of Final Report to NCOPE Submit Abstract to NCOPE Initiate study Subject recruitment (if necessary)

13. Gathering Materials-Data-Information Must have regardless of study format: • NCOPE cover page

14. Gathering Materials-Data-Information Must have if involving Human subjects : • Subject or subjects • Signed letter of informed consent • IRB approval if done at a Qualified Research Organization

15. Presentation of the abstract to our Certified staff • “Opportunity” to get feedback on the size and scope of the study • Frequently an offer to help w/ data collection or subject recruitment

16. Conducting the study: • Patient Trials: • Speed • Stride length • Velocity

17. Conducting the study Surveys(other category): • Patients • Physician • Practitioner • Technician • High School Students

18. Conducting the study • Patient Records: • Diagnosis • Device • Age • Gender • Length of Treatment • “Life” of device

19. Producing the written document Review key elements: • Presentation of literature • Discussion of the results • Careful evaluation of conclusions drawn • Suggestions for future work

20. Producing the written document • After reviewing the final draft for spelling & grammar—The entire document is shipped to NCOPE

21. Implementing a Directed Study process in a Private Practice • Selecting a topic • Designing the study • Developing a timeline for completion • Gathering information/materials list • Study assembly • Producing the written document

22. Questions??