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 

We are pursuing the experimental/quantitative design because we will be establishing a

specific hypothesis about the effects on CTV coverage when using a single-phase scan in
comparison to the phase-gated average scan in the verification planning process for phase-
gated treatments. We will be trying to answer a specific question about verification scan
CTV coverage by showing statistical evidence.
 
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. 

Group members will receive IRB approval.

 
3. Will your study be prospective or retrospective? 

Our study will be retrospective because we are gathering data from verification scans that
have already been performed. 

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

collection 

A total of 20 samples.

A mix of liver, lung, and esophagus patients to include plans that both did and did not
require replanning throughout the course of treatment.

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)?

Dose metric statistics: CTV coverage (V95%) We will compare this between the two
verifications for each patient.

We will also have an expert physician review the verifications and provide a clinical
interpretation of any clinically significant differences.

3. What are your inclusion criteria? Exclusion criteria? 

Inclusion: Phase-gated proton patients including esophagus, liver, or lung treatment areas
with prior verification scans completed.

Exclusion: Patients that did not receive phase-gated treatments or verification scans. 

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.) 

One person will be completing the verification planning.

The same workflow will be used to generate the verification plan.

Verification plans completed on a single-phase scan will be compared to verification plans

that have been completed on the phase-gated average scans. 

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). 

Not needed- All patient-related information will stay within the clinic. 

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 the data will stay within the clinic- in this case we should not need to anonymize it.

7. What resources (in addition to the literature search) are available for you to
use? 
MDA staff to help with understanding the verification process.
Physician to help with verification reviews.
Physicist to help with database query.

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints): 
None 

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) 
Katelyn Knoepke
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries) 
Jenn DeWeese
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer 
Katelyn Knoepke
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. 
Joseph Spencer
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