1. Protocol Design Grace Brannan, Ph.D. CORE Research Office Room 030, OUCOM, Ohio University Athens, OH 45701 (740) 593-2380 www.ohiocoreonline.org February 1, 2007

2. Andrew Taylor Still “If we wish to be governed by reason, we must take a position that is founded on truth and capable of presenting facts, to prove the validity of all truths we present. A truth is only a hopeful supposition if it is not supported by results.” The Philosophy of Osteopathy by A.T. Still (1899)

3. Practical Applications Knowing which practices are ‘best’ Contributing to the knowledge base Meet program research requirements

4. Today’s Goals To provide an overview of research protocol design and tips for success. To provide research training materials.

5. Typical Timelines Project Type Review Requirements Typical Timeline Single-case Report No Review2-3 months Retrospective Study IRB Review2-12 months Prospective Study IRB Review6-24 months Meta- Analyses No Review2-6 months

6. Typical Routing Path Research Experience Research Outcomes Idea Statistician Editorial Support Graphic Design Funding Clerical Support IRB Data Collection Researcher

7. Characteristics of a Good Research Question FINER Feasible Interesting Novel Ethical Relevant Designing Clinical Research (2 nd Ed.) by S. Hulley, S. Cummings, et.al. (2001)

8. Sections of a Research Report Retrospective/Prospective Introduction/Background* Methodology* Results Conclusions References* *Sections of a protocol.

9. Research Protocol Protocols are written to explain the basis and rationale for Retrospective and Prospective studies. Introduction/Background Methodology References A well written protocol is 3/5 of the final paper.

10. Searching the Literature Start with a well-defined Idea. Clearly identify the Topic Areas covered by your Idea. Search those topic areas in Medline/PubMed; Generally, you want to combine terms to find the intersection of several topics.

11. Surveying the Literature Questions to ask: Has someone already conducted research on this idea? If so, can I tailor my idea to tease out more specific details of the idea? Population – Rural vs. Urban Race or Ethnicity Gender Is my idea unique?

12. Evaluating the Literature Are my source materials reliable? Books Journals Conference Proceedings Scholarly Magazines Popular Magazines Web Sites Advertising Source: Your Research Project, Andy Hunt (2005)

13. Reference List and/or Bibliography Using/Choosing the proper editorial style. Mandated by Specialty College Mandated by Program Director Choice based on journal submission guidelines Personal Choice Citing the Literature

14. Requirements of Research Studies RequirementRetrospectiveProspective Research Protocol √√ Data Collection Sheet √√ Data Extraction Plan √ IRB Approval & Training √√ HIPAA Statement from Data Source √√ Consent/Assent Forms √ Instrument Information √ Recruitment/Debriefing Text √ Data Safety monitoring board, if applicable √

15. The Standard Research Paper Introduction/Background* Methodology* Results Discussion/Conclusion References* *Sections typically included in a research protocol

16. Key Issues in Methodology Risks or discomforts Costs Project flow Inclusion/Exclusion criteria Data storage Reliability Validity Data safety monitoring board Number of performance sites Recruitment Scientific objectives Hypotheses Proposed analyses Benefits Deception Questionnaires Compensation Coercion Consent process HIPAA

17. A Thought About Statistics Statistics are used into two primary ways: To describe data gathered from a sample, and/or To make inferences about a population based on data collected from a given sample

18. Data Collection Data collection sheets Typically are produced in Excel Consist of a 2-way array (columns are variables and rows represent subjects) Data extraction plans A mechanism to safeguard from double-sampling Facilitate adhering to a specific timeline

19. Data Extraction Plan Study Title: Does the use of ____ alter the average length of stay of _____ patients in a community emergency department? Author: Dr. _____________, DO Site: Doctors Hospital, Columbus, OH 10/1/05- 10/15/05 10/16/05- 10/31/05 11/1/05- 11/15/05 11/16/05- 11/30/05 12/1/05- 12/15/05 12/16/2005- 12/31/05 1/1/06- 1/15/06 1/16/06- 1/31/06 2/1/06- 2/15/06 2/16/06- 2/28/06

20. Data Collection Form Data Collection Form to Determine Efficacy of Treatment Treatment 1=Old 2=New On Pain Medication? 0=No 1=Yes Location of Dysfunction 1=Upper Cervical 2=Lower Cervical 3=Upper Thoracic 4=Lower Thoracic Degree of Pain 1=No pain 10= Worst pain imaginable Ranking of Symptom 1=Most important 5=Least important

21. Basic Elements of Consent Explanation of the study Purpose, procedures to be followed, duration of participation and identification of procedures that are experimental Participation is strictly optional (voluntary) There is no penalty to refuse or to withdraw Alternate treatments Risks and/or discomforts Benefits, if any Compensation Confidentiality Contact information

22. Liability: Research Support CLEAR distinction between treatment and research CONSENT, when required ACCURACY and completeness of research protocols and all supporting documents

23. Authorship Individuals that make a significant intellectual contribution to the work via: Original idea and/or concept Design Project Execution/Implementation Writing Work typically NOT warranting authorship: Data collection, data entry, typing, computer coding, statistical analysis, or editing

24. Today’s Goals To provide an overview of research protocol design and tips for success. To provide research training materials.

25. Thank You!