Research Design

Phase II Research Organization Document

The next section of your research organization document is considered a “mockup”
of your research design. Remember to answer these questions in the discussion forum for
feedback from the instructors. Looking ahead, you will use this document to create a formal
research proposal later in the semester.

Basic Study Components

1. What research design are you pursuing?
A Quasi-experimental Design will be used. Previous patients who have been candidates for
Quad Shot radiation therapy (control) will be replanned with both Quad Shot and Lattice. These
plans will be manipulated with a new Quad Shot plan following specific planning parameters.
The same patients will be planned with specific Lattice parameters and compared.

2. Do any group members need to obtain IRB approval? [To determine if you need IRB
approval from your clinical site to conduct research, ask your clinical preceptor.
**Note: If you need to obtain IRB approval, you CANNOT use that site for DATA
COLLECTION due to issues in past years. The student at that site should have a
different role in the project (writer or data analysis)]. List each student in the group.
Two of the three group members require IRB approval. The third group member is waiting for an
answer from the research committee.

3. Will your study be prospective or retrospective

Our study will be retrospective.

4. Number of research samples (ex: patients or survey participants) for data collection
The number of research samples is to be determined. We will, however, complete a case study
with 1-5 individuals.
Data Collection Details
1. How many clinical sites will you be collecting data from?

We will be collecting from one clinical site.

2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?
In our planning study, we are specifically interested in limiting dose to the carotid artery by 5%
for retreatment patients.
3. What are your inclusion criteria? Exclusion criteria?

Our inclusion criteria will be head and neck cancers with tumors approximately 5cm in diameter
and having a PTV within 5mm of the carotid artery.
Our exclusion criteria will be any tumors that are below 5cm in diameter, not in the head and
neck, and PTV’s that are not within 5mm of the carotid artery.

• There are 2 eligible cases at Jamie’s clinical site and up to 5 cases at Landon’s site.

4. How will you limit the number of variables in your study? (For example, if you are
doing a planning study, only 1 person should be doing the planning to eliminate the
variables.)
We will limit variables by having only 1 person do the planning and using the same optimization
and normalization parameters for each patient. The planner will have the contoured carotid artery
verified by the same dosimetrist/physician for all cases.
The planner will also use the same sphere parameters and grid spacing for each case; however,
the number of spheres may differ based on the size of the defined GTV.

5. How will you anonymize your patients? (It is often necessary to transfer data sets or
patient information between group members. It is VERY IMPORTANT that you
respect HIPPA protocols! If you need to transfer data sets between facilities, we can
assist you through ProKnow. If you simply need to transfer data using a
spreadsheet, you must anonymize the patient information. It is up to you to decide
how to do this).
The patients chosen for research will have their datasets copied. The copied datasets will be
anonymized prior to working with them so there is no PHI risk. The replans created on the
copied, anonymized datasets will not be connected to the original patients.

6. How will you record your data for evaluation? (All anonymized data should be
housed in OneDrive. The data collector may keep a spreadsheet of the anonymized
datasets in the clinic if needed. This should not be shared with anyone outside of the
clinic)
Data collection will be completed on spreadsheets in OneDrive and shared with all group
members.
 7. What resources (in addition to the literature search) are available for you to use?

Physicists and a physician at Landon’s clinical site

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
• RTOG 8502
• A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients with
Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
• VMAT Grid Therapy: A Widely Applicable Planning Approach
Group Roles
Roles of each group member (members may have multiple roles)

Group Leader-someone who will keep the group on track, make sure group
members are adhering to deadlines, be the direct point of contact for the
instructor with overall questions, update the research organization
document throughout the course of research)
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries)
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer
Writer-someone who is responsible for writing the outline (later in the
course) and the paper; usually the best writer of the group takes this role
**Only 1 group member can write the paper so that the tone of paper is
consistent.
Editor This should be ALL group members except the writer
***The highlighted roles are the roles that require the most work and should be split
between all 3 group members. If you have a group of 2, the work must be divided
equally.

Group Leader: Jamie

Data Collector: Jamie
Data Analysis: Sawyer
Writer: Landon
**Roles may change based on IRB approval/requirements
Project Template
What project template will you be following? (review the quantitative or qualitative
lecture).
The project template that we will be following is a case study.