Paige Solie, Bryan Stump, Cortney Cashner 1

Group 4

Phase II Research Organization Document

1. What research design are you pursuing?

Group 4 will be pursuing an experimental-type research design. We are proposing a case study
composed of patients receiving treatment for Dupuytren’s and/or Ledderhose.

2. Do any group members need to obtain IRB approval? List each student in the group.
No, group members Paige Solie, Bryan Stump, and Cortney Cashner do not require IRB
approval for this study.

3. Will your study be prospective or retrospective?

This will be a retrospective study as we will be observing patient treatment planning and looking
at treatment plans of recently treated patients.

4. Number of research samples (ex: patients or survey participants) for data collection
Due to the rarity of these diseases, we expect two to four patients to utilize in our data collection.
Data Collection Details
a) How many clinical sites will you be collecting data from?
We will be collecting data from one clinical site named Poudre Valley Hospital in Fort Collins,
Colorado.
b) What information are you interested in?
We are interested in collecting data on the skin dose via MOSFETS readings, energy used,
isocenter placement, bolus, depth, special consideration for patient set-up, and differences in CT
sim and clinical set-up sim.
c) What are your inclusion criteria? Exclusion criteria?
We are including data on all patients being treated for Dupuytren’s and/or Ledderhose disease.
d) How will you limit the number of variables in your study?
Only Bryan is collecting data, so all treatment plans will abide by his site’s treatment planning
protocols to limit variability. All patients treated at this site for these diseases receive the same
radiation dosage and fractionation. The patient is treated standing erect for treatment of the hands
and in the prone position for the feet.
 Paige Solie, Bryan Stump, Cortney Cashner 2

Group 4

e) How will you anonymize your data for evaluation?

Patient information will be anonymized by utilizing HIPPA protocols. No pictures will include
patient identifiers. Any written information will not contain MRN, name, date of birth, etc. If any
patient information needs to be used then we will assign the patient a letter and number i.e., 1A,
to ensure patient anonymity.
f) How will you record your data for evaluation?
We will record the MOSFETS readings on a spreadsheet. Anonymized pictures of patient set-up
will be kept as well as anonymized screen captures of the corresponding patient’s CT data. We
will record information about plan parameters and data from the TPS.
g) What resources (in addition to the literature search) are available for you to use?
We have access to many resources such as physicians, physicists, dosimetrists, and radiation
therapists at our respective clinical sites. We also have resources at our clinical sites such as their
computers and treatment planning systems. UW-L instructors and UW-L data analysts and
statistics resources may also be used.
h) Previous research study that will be used for data analysis (ex: RTOG study
constraints):
We have found no studies at this time and have searched in RTOG and the Medical Dosimetry
journal specifically.

Group Roles
Roles of each group member (members may have multiple roles)
Paige Solie- Writer and Group Leader
Bryan Stump- Data Collector and Editor
Cortney Cashner- Data Analysis and Editor

Project Template
What project template will you be following? (Review the quantitative or qualitative
lecture).
We will be following the Quantitative Experimental template.