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?

Retrospective Quantitative Research Paper with a sample size of roughly 20 patients.

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.

Yes

3. Will your study be prospective or retrospective?

Retrospective – Determining if our method is more efficient at determining when adaptive

planning is necessary than the current practice.

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

More than 10 with a goal sample size of 20-30

Data Collection Details

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

One clinical location – This will help to limit uncontrolled variables in data collection and
analysis.

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

Retrospective review of images to determine when adaptive planning would have been
necessary using our method compared to when the patient actually had adaptive planning.

- Most specifically patient skin surface measured on Initial planning scan, any available
daily images, adaptive planning re-scans or any other imaging modalities where
external surface is measurable.
 - We will be evaluating the volume of skin surface (volume measured by creating a
1mm thick rind at the external surface) that falls below 3mm and 5mm inside of the
20% isodose line. The 20% isodose line is a good measurement for entrance of
primary beam and any external surface changes outside of the 20% isodose would, in
theory, not affect the dose in the PTV.
- When the patient was replanned in their course of treatment and what the measured
external tissue differences were at the time of replanning

3. What are your inclusion criteria? Exclusion criteria?

Inclusion Criteria:

- Primary cancer of the Head and Neck

- Patients finished with their initial course of primary radiation therapy
- Treated with Proton therapy
- Must have had a re-plan or re-scan due to tissue changes or weight loss
- Must have had a re-scan or cone beam CT scan that would have determined tissue
loss.

Exclusion Criteria:

- Re-scanning for replanning not completed during patient’s entire course of radiation
- No secondary imaging that would allow us to generate our rind contours for
evaluation
- Patients that did not finish their course of treatment for any reason
- Pediatric patients (We will be focusing on adult (18 and older) populations for this
research study

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.)

- 1 person collecting data at one clinical location

o This will allow us to test our method against one institutions current method
of analysis for replanning.
- Having strict inclusion criteria so that we have a similar grouping of study patients
and to eliminate outlier data.
- Creating a strict method of data analysis that will be used the same way on every set
of data from our randomized patients.
 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).

- Data will be collected at one institution and randomized through entry into an excel
spreadsheet. Once Fully anonymized in the excel spreadsheet, a second researcher
will analyze the data that was collected by the initial researcher. No patient
information will be available on the excel spreadsheet our outside of the primary
institution. There should be no need to transfer data sets between institutions in this
study so secure transfer protocol does not need to be set up.

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 will be collected at one institution and entered into an excel spreadsheet. The
spreadsheet in OneDrive will have no patient identifiers in it whatsoever and the data
will be analyzed by a second researcher that has no knowledge of the initial patient
database. This will help to protect patient information and prevent any bias that could
occur by one researcher doing both data collection and analysis.
- It will be up to the data collector to keep a separate anonymized spreadsheet of patient
data for further information, if needed, but that information will not be given to any of
the other researchers in this group.

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

- Murphy Library, Department physics staff, Department Dosimetrists, Previous patient

data sets

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

Group Roles
Roles of each group member (members may have multiple roles)
 Group Leader- Tim Zehnder
Data Collector(s)-Tim Zehnder
Data analysis-Sara Kempton
Writer-Lauren Giesking
Editor Everyone
***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).
Quantitative