Please also see syllabus
Overview
A requirement for fellowship is to complete a work of scholarly activity. Scholarly activity comes in many forms – a case report, a quality initiative or a project involving an original idea.
Participation in original research develops the important skill set of understanding the concept of the scientific method (asking a question, developing a hypothesis, testing the hypothesis, and drawing conclusions from the testing).
Requirement # 1: Project of scholarly activity
- Fellow must be the primary driver of the project
- Must present the work at a national conference
- Project must be complete and in written form before graduation
Fellow can choose from one of these categories
1. Original research
2. Case report
3. Quality Initiative project (Must be the primary fellow, as defined by the person presenting at a conference, and the primary author of the paper)
4. Review article
Requirement # 2: Syllabus reading
Didactive reading and lecture assignments will be assigned for each research elective. These should be read/completed by end of the research elective.
Requirement # 3: Journal club
During each research elective month, fellow must present a journal article for discussion. Choice of article is at the discretion of the fellow. Pulmonary topics would be favored, and will be presented on one of the Wednesday fellow conference slots at 11:30. Lunch is served.
Ideas for research projects
1. Abandoned/unfinished projects list
You can pick from one of these projects that were abandoned and pick up where the graduated fellow left off. The choice of projects is yours to make. The list of abandoned projects can be found in the research section on hfhpulm.
2. Reading
3. Discussion with a mentor
A list of staff projects can be found on hfhpulm. All staff are receptive to fellow participation in research. IF a staff is not listed in the research list, please arrange to meet with them to discuss ideas and there interest in being PI for your project.
Suggested timeline for completing milestones
| !st Year July-December | Completion of Citi training Work on one abandoned project Literature review of primary project |
| 1st Year January – June | Primary project and PI identified IRB submitted Begin data collection |
| 2cnd Year July-December | Complete abandoned project Data collection primary project |
| 2cnd Year January – June | Data Collection Primary Submit manuscript abandoned project |
| 3rd Year July-December | Manuscript primary project |
| 3rd Year January – June | Present at ATS Submission of primary manuscript |
Evaluations will be done by the Research Director and the PI/mentor of the project. Evaluations will largely be based on completion of milestones. Milestones will depend on the current progress and year of fellow so will be specified at the beginning of each research rotation.
Milestones and tasks will be accessible in the Pulm research database site (login at hfhpulm.com)
Preliminary requirements to be done before starting the research track.
1. Citi Training (Research Ethics and Compliance Training). This is required for all individuals engaging in research at Henry Ford. Email Jeff Jennings and Jackie Day with the certificate.
2. End note installation. Endnote integrates into Word and is used to track references for your manuscript
3. Make sure you have a login for the research database at hfhpulm.com (direct link: http://rhwweb392c/telephone/main_login.php). Kesha will have sent you an email with your login information.
You can look at all of the active projects that are ongoing as well so as to help choose a mentor for your research track.
Primary Research Project By January of 1st year, each fellow should have a working idea and a hypothesis. This will be a process that is done in conjunction with your staff mentor. This process involves a simple checklist:
- Has it been done before?
- Is the question important/pertinent; does it introduce new knowledge on the subject (the “who cares” test)?
- Is it feasible?
The project or even idea will likely need to be modified (or rejected altogether) as the question fails one or more of these checklist questions.
In mid-January the idea should be presented to the pulmonary group. An interested PI may be assigned on that day unless the project already has a PI.
You should expect to start the project after IRB approval and present your findings at a national conference, sometime before you graduate.
Case Reports do qualify for the scholarly activity requirement for your fellowship. However, they MUST be presented nationally and written up (in publishable form) before graduation.
Quality initiatives These projects are very similar to the original research project. They can still be published. The difference is you are testing a process. With a research project you are testing a hypothesis.
QI Process: How can we implement a process to improve compliance with ventilator weaning?
Research: Hypothesis: a ventilator bundle team increases compliance with vent weaning, as compared to a control group.
Guidelines for authorship
First author – by default, a fellow starting a de novo original research project will be first author. Active involvement throughout the project is required to maintain first authorship. Active participation in study design, IRB submission and data collection and manuscript writing. The degree to which your mentor “helps” at each stage should not adversely influence your first authorship, as it iss expected that the PI will be actively involved.
Senior authorship (and corresponding author). The staff PI will have senior authorship. This is invariably the last name on the paper. This person will be the corresponding author.
Middle authors All people who work on the project in any significant way, should be considered for middle authorship. The degree of contribution is somewhat subjective but in most cases middle authorship should be given if the person contributes to the project. Contribution may be limited to certain aspects (i.e. manuscript writing, or statistical review, or data collection). The amount that a person contributes is related to the order of authors on the paper. A second author has typically contributed more than a third author.
Occasionally, another staff (or fellow or resident) may be involved in the project and their place on the paper will depend on the degree of their involvement. Someone who works hand in hand with the senior fellow will get second authorship for example. If the original fellow no longer participates in the project halfway through, or does not work on the manuscript, they will still be on the paper, but first authorship may go to another person if their contribution is greater in the end.
Topic 2 – Write an introduction for an original research study.
Materials:
1. Powerpoint lecture
2. https://alison.com/topic/learn/86305/literature-review
Pre-Requirements: EndNote should have been installed.
Your assignment is to write an introduction that leads up to a hypothesis. NOTE: this may or may not end up being your actual project. If it is, that’s nice but the point of this exercise early in your elective is to practice searching for literature and incorporating references into the introduction. The goal of the introduction is to get from point A (background) to point B (the hypothesis).
In other words, the purpose of an introduction is to justify the hypothesis of your project. This is done in 4 steps. Each step gets more SPECIFIC towards the ultimate hypothesis
1. state the importance of the overall problem (eg. COPD is the leading cause of death in smokers)
2. State what is known about this problem (references)
3. State what holes or unanswered questions remain about the problem
4. State a potential reason for this
5. State your hypothesis which is attempting to test one of those unanswered questions in step 3.
In order to write the intro, you would of course already have the hypothesis and then you work toward that (hypothesis is usually the last sentence in the introduction).
Topic 3 – Scientific Method
The scientific method is a process whereby you making conjectures (hypotheses) and derive predictions from them. You then carrying out experiments or empirical observations based on those predictions. When you start a project, you will be in essence following the principles of the scientific method.
The steps of the scientific method:
1. Make an observation or observations.
Example: Perhaps on rounds a question would arise We sure are ordering a lot of EEGs for encephalopathy.
2. Ask questions about the observations and gather information (this is the literature or background review).
How useful is the EEG…i.e. what is the diagnostic yield in the medical ICU??
3. Form a hypothesis — a tentative description of what’s been observed, and make predictions based on that hypothesis.
“EEGs increases frequency of hospice consults in patients with unspecified encephalopathy”
Generic: “If _____[I do this] _____, then _____[this]_____ will happen.”
4. Test the hypothesis and predictions in an experiment that can be reproduced.
-This is where study design comes into play. Choose the setting (patient population) and the type of study to test the hypothesis (RCT, case-control, etc).
-this step will also involve the ultimate collection of the data (either prospectively or via chart review).
5. Analyze the data and draw conclusions; accept or reject the hypothesis or modify the hypothesis if necessary.
6. Reproduce the experiment until there are no discrepancies between observations and theory.
“Future studies are needed to confirm our findings of this single center non-randomized observational trial”
7. Communicate Your Results
Presentation at national conference and then publication of the manuscript.
Some key underpinnings to the scientific method:
- The hypothesis must be testable and falsifiable Falsifiable means that there must be a possible negative answer to the hypothesis.
- Research must involve deductive reasoning and inductive reasoning. Deductive reasoning is the process of using true premises to reach a logical true conclusion while inductive reasoning takes the opposite approach.
- An experiment should include a dependent variable (which does not change) and an independent variable (which does change).
- An experiment should include an experimental group and a control group. The control group is what the experimental group is compared against.
Conclusions
Assignments:
– scientific method work sheet Sponge Bob
Topic 4 Study Designs
Choosign the correct study design is critical for successfully testing your hypothesis. A hypothesis can be test experimnentaly (you provide an intervention and compare to a control group) or by observation “you observe the phenomena without intervening, and comapre to a natural (control) group.
Please refer to this handout for a description of the study designs.
Special mention: Pilot and Feasibility Trials
Tests feasibility for a larger trial (outcomes are things like recruitment rates, retention rates, completion of action plans, completeness of data) with those issues checked off, the larger study can have the official outcomes to test the hypothesis. Feasibility trials are not really for “hypothesis generating” etc.
https://youtu.be/bljPT9whkQo (Pilot vs feasibility 25:46 mark of 1:01:35)
Handout: BMC Medical Research Methodology 2010:10:1
Topic 5 Power analysis.
All studies that have a comparison (control) group require determination of sample size. This is the minimal number of subjects needed to provide enough “power” adequately compare the control and the experimental group and accept or reject your null hypothesis. In English – how many subjects do you need to test your hypothesis. If the two groups show no difference for a given outcome, how many subjects do you need to be able to say that this is truly no difference? If you have 5 patients in each group and 4 die in only one group, is that because you have too low of a sample size?
In determining a sample size, you need to know the prevalence of the disease in that population you are studying AND you need to say what you think the difference would be between groups.
Videos:
1. Statistical Power, Clearly Explained https://www.youtube.com/watch?v=Rsc5znwR5FA
2. p values clearly explained https://www.youtube.com/watch?v=5Z9OIYA8He8
3. Sample size table – https://www.research-advisors.com/tools/SampleSize.htm
4. Webinar Series: Sample Size https://www.youtube.com/watch?v=PZcm57CTKsk&feature=youtu.be
Topic 8 How to write a manuscript
Readings:
How to write a scientific manuscript for publication – Blood Transfus. 2013 Apr; 11(2): 217–226.
Other articles located in the curriculum folder.