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?

We will be utilizing the Quasi-experimental design for our research. We intend to

control and manipulate diagnostic CT scans without randomization or a control group.

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.

We are currently seeking further clarification on Ohio State’s protocol for IRB
approval and whether or not an IRB approval is necessary for retrospective studies. We
are actively working towards IRB approval/exemption.

3. Will your study be prospective or retrospective?

Our study is retrospective in the sense that we are collecting data (treatment
plans and diagnostic CT scans) from patients that have already completed treatment.
However, we will be overlaying treatment plans on already obtained scans for
quantitative comparison.

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

Currently, we are considering using a range of 10-20 formerly treated patients in

our study.

Data Collection Details

1. How many clinical sites will you be collecting data from?

We are planning to collect data only from our clinical site, The Ohio State
University Wexner Medical Center – The James Cancer Hospital.
2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?

We are interested in exploring the benefits of Simulation Free Computed Tomography

(SFCT). After reading other research studies, uncompleted research has been done to
confirm the fidelity of dosimetric deliverability on emergent patients who have already
received treatment. Currently, patients must undergo a separate radiation planning CT
although having already received a diagnostic scan. We want to further assess the necessity
of this additional CT and its practicality.
We plan to assess the variations between variables such as dose distribution, organ at
risk (OAR) doses, and global dose maximums. We would also consider the geometric and
structural differences between diagnostic CT and planning CT tabletops. We will establish a
process of artificially altering the tabletop in Eclipse treatment planning software for proper
dose delivery when planning utilizing a diagnostic CT.

3. What are your inclusion criteria? Exclusion criteria?

Heterotopic Pelvic Bone treatments

Heterotopic Bony Pelvis

Inclusion Criteria Exclusion Criteria

Patients who have received emergent
radiation treatment for the prevention of
heterotopic ossification.
Patients treated 2D or 3D conformal
using opposed beam arrangements at 0
and 180 degrees.
Patients treated at the James Cancer
Hospital.
Patients who have been treated to
prevent heterotopic ossification but have
not received a diagnostic CT scan.
Patients under the age of 18.
Patients not treated to 8Gy in a single
fraction.

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.)
For the planning on diagnostic CT scans:
 Utilizing the same planning software (Varian’s Eclipse treatment planning
software).
 Utilizing the same treatment planning beam arrangements (AP/PA) with margins
from previously completed treatment plan.
  Planning treatments on the same Varian Truebeam Linear Accelerator.
 Utilizing the same patient database.

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).

We would anonymize the patients by removing patient identifiers like

patient name, MRN, DOB and by referring to them in the study using generic
identifiers such as treatment energy, fractionation scheme, extent of target
volume, etc. All group members are completing clinicals at the Ohio State
University and thus all group members can access patient data internally within
Ohio State’s network.

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)

The data can be recorded for evaluation by utilizing an Excel spreadsheet

contained within The Ohio State University’s secure network to keep track of numerical
data and designate specific identifiers to specific patients. To anonymize the patients, a
list could be created within our clinic’s secure network that includes patient identifiers,
like MRN, and would designate a generic term or number to refer to the patient that can
be used outside of the secure network.

7. What resources (in addition to the literature search) are available for you to use?
 OSU’s Archived patients
 Varian’s Eclipse treatment planning system
 OSU’s Picture Archiving and Communication System (PACS)
 8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):

Schiff JP, Zhao T, Huang Y, et al. Simulation-free radiation therapy: An emerging form of
treatment planning to expedite plan generation for patients receiving palliative
radiation therapy. Advances in Radiation Oncology. 2023;8(1):101091.
Doi:10.1016/j.adro.2022.101091  

Group Roles
Roles of each group member (members may have multiple roles)

Group Leader- Katie Williams

Data Collector(s)- Sydney Raver
Data analysis-Joshua Dutton
Writer- Katie Williams
Editor(s) - Joshua Dutton & Sydney Raver

Project Template
What project template will you be following? (review the quantitative or qualitative
lecture).

Quantitative. Our goal is to answer a specific question utilizing statistical evidence with a
specific hypothesis addressing a single issue with tangible data. 1 We have total control
and manipulation of our variables. We will be utilizing scientific research while gathering
usable and measurable data throughout our project. By using this method, our data can
be verified using the scientific method.1  

References 
1.Leonards N. Research Basics and Research Process. [SoftChalk]. La Crosse, WI: UW-L Medical
Dosimetry Program; 2023.