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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?

Quantitative, or experimental type

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.

Data collection will be obtained from the University of Virginia. An IRB is not required.

3. Will your study be prospective or retrospective?

Retrospective. We are specifically going to collect OAR DVHs. These DVHs will be used to
calculate a single predicted NTCP value for each OAR, for each planning method. The actual
biological end point/ toxicity that that patient got/ might get in the future is not
considered.

4. Number of research samples (ex: patients or survey participants) for data collection

A minimum of 10 patients will be collected and depending on time, resources, and


requirements, we could add more.
Data Collection Details
1. How many clinical sites will you be collecting data from?

One site. The University of Virginia

2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?

Finding the NTCP values of the bowel bag, sigmoid colon, bladder, femoral heads, and the
cauda/spinal cord.

However, we found NTCP parameters for colon, but not bowel bag. We are not sure if we
want to stick with the above OARs, or only with what we found in Luxton et al. 1
References:

1- Luxton G, Keall PJ, King CR. A new formula for normal tissue complication
probability (NTCP) as a function of equivalent uniform dose (EUD). Phys Med Biol.
2008;53(1):23-36. doi:10.1088/0031-9155/53/1/002

3. What are your inclusion criteria? Exclusion criteria?

Inclusion criteria: Rectal cancer patients (male or female) of any age, that have
specifically been simulated for rectal cancer radiation treatment and have had their
target volumes already delineated by the assigned Physician. We will include all types
of fractionation regimens as the NTCP model will convert the fractionation regimen in
use to a 2Gy/fraction regimen. Also, treatment techniques that were used to treat these
patients will be irrelevant as we will create new VMAT and 3DCT plans for each patient.

Exclusion criteria: We will not include any patients with prior radiation treatments, or
with nodal involvement, or boost/ additional targets.
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.)
 Single person planning
 Comparable patient positioning (prone)
 Set field arrangements and arc trajectories
o For 3D: 3 field PA with Laterals
o For IMRT: Posterior arcs
 Set PTV dose coverage goals
 Consistent contour volumes and naming

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 data collector will plan the patients and keep a record of the patients by name and
arbitrary number (1-10...) which will remain at the clinic site. Only patient number, DVH,
and screenshots of plans (not including patient information) will be shared.

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 for evaluation will be stored in the “Group 6” OneDrive.

7. What resources (in addition to the literature search) are available for you to use?

MATLAB will be used for NTCP analysis, statistical analysis and plotting / graphs.

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):

We will be using QUANTEC constraints when optimizing patient plans.


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.
Data collector- Trevor Moe
Data analysis- Shahad Al-Ward
Writer- Shelby Wingold
Project Template
What project template will you be following? (review the quantitative or qualitative
lecture).

Quantitative

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