Residency Research Manual: Steps & Suggested Timeline

This section contains information regarding the different steps in the research process and a proposed timeline for the completion of your residency research requirement.

Specific information for your Specialty can be found under the tab "Research Information by Specialty." Please note that at this moment Program Specific information is incomplete. If you have documentation specific for your Specialty which you would like to have included please contact ILORSP@midwestern.edu.

Research Process, Steps, and Timeline

The figure below provides a schematic overview of the research process. It gives an idea of the steps to take and the sequence in which these are to be taken. This illustration seems to imply a unidirectional process. In reality this process is not always this “clean”. At times you may feel like you have taken a step forward but two back; that is OK and to be expected. For example, after reviewing the literature you may conclude that the research project you had planned has already been done or that another researcher mentioned limitations you never thought about and now you need to “rethink” your project. You then take a couple of steps backwards and start the process again in a slightly different direction (i.e. using a different instrument, recruiting different subjects, etc.). The end result of research, sharing your results with others (i.e. a research report, a publication, poster presentation), is also missing an arrow in the graph below; the arrow back to the theory. Research results either confirm a theory or contribute to evidence that a theory needs to be changed.

Each step of the research process consists of a variety of tasks which need to be completed. The table below gives an overview of these tasks. A table more specific to your residency (i.e. Emergency medicine, Family Medicine) can be found in the section on Research Requirements and Timelines by Specialty. Appendix 1 also provides a generic overview of steps in designing a clinical research project.

What you should plan on doing:

Topic Selection and Faculty Research Mentors

You are probably very busy with learning how to effectively and efficiently care for patients. This includes becoming familiar with your responsibilities such as rounds, calls, medications, and interventions. You do not need to rush to start a literature search…. But you do need to start thinking of possible research projects.

How to Generate Ideas:

This really is one of the first steps in the development of your research project. Most clinicians can easily come up with good ideas about clinical research based on gaps in existing knowledge.

Where can you look for ideas? Below are some ways to develop your own ideas:

• Keep your eyes open for interesting clinical cases which may provide topics for research.
• Read journal articles on subjects of interest in various specialties; pay particular attention to author’s conclusions for areas needing further research.
• Keep a list/journal of all potential research ideas; keep refining the topics and ideas as your knowledge increases, talk to other clinicians about your ideas.
• Become familiar with the ongoing research at your institution; join a project and propose your own research as an offshoot of that project.
• Brainstorm with peers in your specific discipline to determine gaps in overall knowledge and understanding of that specialty.
• Look for the variation between the articulated standard of care or established practice guidelines and the day-to-day reality of clinical practice; why do variations exist? Is there an evidence-base for the preferred method?
• Did you read an article that interested you? Did you attend a presentation or workshop on a topic you would like to learn more about? Use this as a starting point to ask additional questions.
• Talk to your faculty mentor about it – ask questions about why things are done the way they are taught.

Once you have an idea, or hopefully several ideas, your next step is to perform a preliminary literature search/review on those topics. The section on Literature Review and Library Access in this manual provides you with more information as to the why’s and how’s of conducting a literature review as well as a guide for setting up a library account and gaining access to MWU’s library resources. Information on how to conduct literature searches will also be provided to you during your residency at a variety of workshops on using library resources.

Through the library at MWU you have access to many electronic databases, academic journals, books, etc. which are great resources. At this point in time you do not need to read every article you find nor do you need to print all the abstracts. This step is to familiarize yourself with what types of studies have been done, become aware of what is out there, and what has been done around your particular area of interest. Pay special attention to what the author’s point to as “gaps in existing knowledge” as this may provide you with a great starting point for your own study.

As you move through the process of refining, narrowing down, and redefining your research topic you should keep in mind the characteristics of a good research idea which are represented by the mnemonic FINER. Ask yourself if your topic fulfills these criteria. A checklist to help you determine if a research project is appropriate for you and if the project is feasible can be found in Appendix 2.

Faculty Research Mentor Selection

Picking a faculty mentor, the right mentor for you, is a very important step in the completion of a successful research project and is one of the first steps in the research process. You will be working with numerous people. With some you will have a more direct relationship with. Is there anyone you get along with well? Is anyone currently involved in research, or was involved in research? Picking the right faculty mentor is an integral piece of a successful project, so it is a great idea to keep your eyes open.

Ideally, do a little research on your potential “mentors”. Look to see if they have any publications (how recent? what topics?). Speak with their co-workers or research partners in an attempt to assess them as a researcher – reliability and predictability come into play here as well. Fellows who worked under the clinician, former residents or medical students are all good resources for you to utilize when investigating your mentor.

This project will require a big commitment from both of you – time, energy, thought. Be sure your faculty mentor is someone with a dependable track record as well as someone with whom you could spend time. When you do decide on a mentor, approach them with your request in such a way that they do not feel obligated or trapped. If they have research experience, they will be familiar with the arduous task ahead. Be clear about your expectations and allow them to inform you of their expectations for you. Give them time to consider the idea, then followup with a phone call, email or personal visit.

Feasible:

Refers to logistics of the study.

• Adequate numbers of subjects
• Adequate technical expertise
• Affordable in time and money
• Manageable in scope

Interesting:

Is this topic interesting to you?

Does it intrigue you and will it keep your attention over the period of a couple years?

Novel:

Would this confirm, or refute previous findings or extend previous findings and lead to new developments?

Ethical:

Amenable to a study that the institutional review board will approve.

Relevant:

Is the topic relevant to scientific knowledge, to clinical and health policy, or to future research directions?

Authors: Hulley, Stephen B.; Cummings, Steven R.; Browner, Warren S.; Grady, Deborah G.; Newman, Thomas B. Title: Designing Clinical Research, 3rd Edition Copyright ©2007 Lippincott Williams & Wilkins

Steps in designing a clinical research project

1. The Planning Steps:
   1. Decide what the research question is.
   2. Write out the objectives/specific aims.
   3. Define the variables.
   4. Define the study population.
   5. Refine the objectives into written, testable hypotheses.
   6. Anticipate error and bias.
   7. Develop the study design/method.
   8. Estimate sample size and power.
   9. Write a protocol.
   10. Plan the data collection process.
2. The Implementation Steps:
   1. Manage and monitor data collection.
   2. Manage the database.
   3. Analyze the results by tables and graphs.
   4. Test the hypotheses with statistical tests.
   5. Generate additional tables and graphs to explain the findings.
   6. Publish the results.

Steps from: © Research Manual for Faculty, Residents, and Medical Students. University of Tennessee College of Medicine Chattanooga.

Checklist for determining if research project is appropriate for you and feasible

The following questions will guide your thinking about the feasibility of a research project. These are not the only questions you should ask  but a good starting point.

What kind of research should I do?

• Examine existing data for trends; explore differences in populations; analyze and describe in a correlational study the relationship between presenting problems, diagnostic findings, and treatment interventions?
• A clinical trial? (use a treatment group only or a controlled trial?)
• A case control study?
• A review of the literature in a specific disease process or treatment?
• An arm of an existing research project?
• Replicating another ongoing study or a portion of an ongoing study?
• Basic science or clinical science?
• Other?

Time and resources?

• Do I have easy access to data or patients?
• Who are the available experts or mentors with the time and experience to guide and support my research?
• What will I need and expect from that person or persons?
• How long do I have or want to take to conduct this research?
• Other:

Data access options

• Am I generating pilot data?
• Are pilot data available that can guide my research design development?
• Is there pilot data that can be analyzed in a different way?
• Is there existing data in an electronic form that I can analyze such as a national survey or other national or local data base?
• Other

Endpoints and products

• Will I publish or present the findings?
• What is the benefit or value to osteopathic medicine or health care consumers?
• Is there a cost-benefit issue to address for this research project?
• What do I expect of myself during and after the project?
• Other

Other resources

• Do I have a biostatistician available to consult on data management and analysis?
• Am I trained in Human Subjects protection issues, IRB procedures, and/or have access to a clinical research coordinator to assist in data collection, and study reports/reviews?
• Other

My own skills

• Do I want to do this?
• Do I have or can I acquire the basic skill and knowledge to accomplish my goals for this research project?
• Am I committed to doing this research project?
• Other

The next step is the design phase. Information about this can be found in other sections of the manual.

Note: The most often cited reason for not completing a study is lack of an adequate number of subjects. Rarely do published reports state that all subjects enrolled completed the trial. Furthermore some studies do not achieve their enrollment goals. Be very careful about this. It is a significant investment of time and other resources, and a potential source of frustration.

Checklist from: ©Manual of basic tools for research in osteopathic manipulative medicine, second edition, April 2007. The University of North Texas Health Science Center Texas College of Osteopathic Medicine