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 a quantitative/experimental 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.
Yes, Jenna and Rashad will need to submit to the IRB to be labeled as exempt. This process
should only take approximately 1 to 2 weeks and not pose an issue for this research
project.

3. Will your study be prospective or retrospective?

Retrospective

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

Our thought is to have approximately 10 patients to analyze plans with and without the
bolus helmet. Once we reach the data collection phase, we will select patient data sets that
are standard. That is, avoid selecting patient data sample outliers that may inappropriately
skew our data.

Data Collection Details

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

One – Mayo Clinic Rochester

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 evaluating the use of the bolus helmet to maintain optic chiasm and
nerve sparing while improving the CTV prescription coverage in head and neck treatments.
 3. What are your inclusion criteria? Exclusion criteria?

Inclusion criteria: The total dose prescribed must be at least 60 Gy using standard
daily fractionation in order for the dose to the optic chiasm and optic nerves to be of
concern. Also, the CTV must be in close proximity to the optic nerves and optic chiasm.

Exclusion criteria: The total dose prescribed is less than 60 Gy, stereotactic dose
regimens, or previous irradiation are our exclusion criteria.

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.)

We will limit the number of variables by collecting data from 1 clinical site for patients
receiving radiation therapy with the same dose regiment.

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).

If we need to transfer data sets between facilities, we will utilize Proknow. We have spoken
with our clinical preceptor regarding this. She is familiar and willing to assist us with this
process if need be. Additional data transfer will be done utilizing a spreadsheet.

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 protected health information will be withheld from the spreadsheet that is shared
between the group. The data collector will keep a separate spreadsheet with
anonymization information if further data retrieval is needed.

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

The statistical consulting center through UW-L is one resource we may choose to utilize.
 8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):

Previous research has shown different types of range shifter extensions can help to
minimize the spot size of the proton beam and thus increase the ability to spare critical
structures.

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)
Rashad

Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries)
Jenna

Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer
Rashad

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
Keith

**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.

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

A research paper will be our project template. Our aim to gather retrospective data on at
least ten patients or more. The bolus helmet is a unique tool that merits further study to
verify its effectiveness in dose distributions.