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 pursuing experiment-question-quantitative research design.

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. We do not have to obtain IRB approval.

3. Will your study be prospective or retrospective?

Retrospective.

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

One case study – papillary cancer of the big toe.

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

One - INOVA

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 planning a big toe for a rare form of cancer and how we
can get the best dose distribution with minimal dose to the other toes.

3. What are your inclusion criteria? Exclusion criteria?

 This is a single case study of eccrine papillary sweat gland cancer of the big
toe.

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.)

This has been planned by a single dosimetrist. This dosimetrist did a VMAT
plan as well as a 3D plan to compare. Each plan also compares using a 3D
bolus vs a silicon bolus. The doctor ultimately chose VMAT with 3D bolus for
the patient’s treatment.

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).

There is only one patient’s information we will be using. No names will be

used when sharing planning information. There will be no data sets
transferred between student facilities. Figures of patient setup and dose
distributions will not have patient identifiers on them. Simulation photos will
not have the patient’s face in them.

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).

Chelse will upload OAR/DVH/Dose tolerance sheets and whatever else is

pertinent to the case to OneDrive without the patient identifiers.

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

The dosimetrist that created the plans, the doctor who prescribed and
approved the plan, and the physicists who help create the 3D bolus and ran QA
on the plan.

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
 Fionda B, A Di Stefani, Lancellotta V, et al. The role of postoperative
radiotherapy in eccrine porocarcinoma: a multidisciplinary systematic
review. DOAJ (DOAJ: Directory of Open Access Journals). 2022;26(5):1695-
1700. doi:https://doi.org/10.26355/eurrev_202203_28238

Neill CJ. Subungual squamous cell carcinoma: A case study. Medical

Dosimetry. 2017;42(2):126-136.
doi:https://doi.org/10.1016/j.meddos.2017.02.003

The first study will be used to lay a background on radiation therapy's role
with eccrine cancers. The second study will be used to compare treatment
parameters with a single digit (study was with the tip of an index finger).

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 and writer – Chelse

Data collector and analyst – Jose

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