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?
Experimental/quantitative

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.
No IRB approval will be required for this study.

3. Will your study be prospective or retrospective?

Retrospective study.

4. Number of research samples (ex: patients or survey participants) for data collection
10 anonymized patient data sets will be used for this study.

Data Collection Details

1. How many clinical sites will you be collecting data from?
One – Froedtert Hospital

2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?
The feasibility of a dual isocenter approach using the RayStation TPS to treat prostate
patients and their involved nodal fields on an MRL.

3. What are your inclusion criteria? Exclusion criteria?

Inclusion:

A. Prostate patients previously treated with a plan created in Monaco by, if possible, a
single Dosimetrist at Froedtert.

B. Prostate patients with involved lymph nodes

 C. Prostate patients treated with a fractionation pattern of 70Gy delivered in 28
fractions total (boost included)

Exclusion:

A. Patients treated with another dosimetrists plan (if possible)

B. Prostate patients with disease confined to the gland itself

C. Prostate patients with metastatic disease extending beyond the regional lymph nodes

D. Prostate patients with a second primary cancer

E. Prostate patients who had received a prostatectomy

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.)

All previously treated patients and data sets will be gathered from Froedtert
Hospital using their Siemens Somatom Drive CT scanner and MIM Clinical. All new
plans will be created by Peyton (Data Collection) in RayStation using the previously
treated plans created, if possible, by a single Dosimetrist in Monaco as a base.

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).
All datasets will be anonymized at Froedtert Hospital before being exported to the
other group members. The patient information will remain anonymized throughout
the analysis process.

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)
All anonymized data will be entered and organized in a Google Sheets file shared
only with this group’s members.
7. What resources (in addition to the literature search) are available for you to use?
 RayStation TPS
 Monaco TPS
  MIM clinical data
 Medical physicists and dosimetrists at Froedtert Hospital

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
a. Froedtert Hospital’s current clinical dose constraints
b. QUANTEC publications
c. NRG-GU009

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) - Peyton Head
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries) - Peyton Head
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer –
Nick Oliver
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. - Jenna Payne
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.
Project Template
What project template will you be following? (review the quantitative or qualitative
lecture).
Research paper