Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

Treatment Plan

The goal of our survey will be to obtain responses from at least 750 self-described African
Americans,and 250 Caucasians.

Method From our previous study we found that relying on responses from surveys placed in
resident mailboxes (which need to be mailed back to us) is ineffective. For this study we
have divided the zip code into roughly four equal quadrants using Broad Street and Erie
Avenue as dividers. We will place a flyer in 1000 mail boxes in each quadrant by hand
delivery. Hand delivery assures that mailings to vacated buildings will not occur. We hand
delivered surveys in our previous study and encountered no problems. This will allow for a
balanced representation from the entire zip code (see data collection section for further
discussion of this point). The flyer informs the participants that the Temple
Gastroenterology department is performing a health survey and gives them a phone number to
call if they are interested. This phone is in a locked lab run by the PI. As compensation
for their time they will receive $25. Only one subject per household is eligible and
interviews can be completed at the hospital or in the participant's home. Only those
individuals willing to be contacted in future years for follow-up will be enrolled. Subjects
must show an identification verifying that their home address is in the zip code (usually a
driver's license).

The overall survey consists of several standardized questionnaires which have been organized
into a logical, easy to complete, comprehensive unit. Patients will complete the survey on a
laptop which contains all the questions in an easy to read and follow Microsoft Access
database file. Essentially no computer skills are needed to complete it except for the use
of a mouse. A member of the research team will sit in the room to help the subject if there
are questions. This survey is password secured such that when the subject completes the
survey they cannot access the responses of other subjects. Answering the last question
automatically closes the file.

The individual questionnaires making up the overall survey are included in this packet.
Initial questions ask the subject their name, address, contact phone numbers and demographic
questions such as income and education level. Subsequent questions are the complete set of
questions from standardized questionnaires such as AUDIT for alcohol use assessment. The
cornerstones of the survey are the 17 question survey on GERD which covers all components of
the Montreal classification, and the 65 questions which make up the Rome III functional
bowel disease questionnaire. We estimate it will take participants 30-60 minutes to complete
depending on age and educational level.

Risks.

The only potential risk is related to confidentiality. Sensitive personal information is
assessed using the survey. Several levels of subject protection will be employed. These
include use of a password protected file for database collection on a computer which is
password protected when turned off. The computer will be kept in a locked office in the
hospital. The phone used to interact with subjects is in lab #7 of the Parkinson Pavilion,
10th floor.

There are no interventions to be performed for this study. There will be, for example, no
blood draws. Future studies may recruit individuals from this database for invasive
diagnostic testing and further data collection but those will be covered under future IRB
submissions.

Benefits

Subjects who participate in the study will develop a greater insight into the possible
causes of their medical problem. In a relaxed environment will they have the opportunity to
talk with a board-certified gastroenterologist about their health. They will be provided
with accurate information and will be encouraged to engage the health care system by
communicating with their primary care physician. The African American community as a whole
will benefit tremendously as their health status within the US is presented in peer-reviewed
literature. This has the potential to shape public policy. Future studies under separate IRB
protocols may provide benefit to them such as free testing for potentially serious GI
diseases.

Data Collection and Statistics

We will recruit a minimum of 100 African Americans from each quadrant of the zip code 19140
with the total adding to 750. Caucasian neighborhoods tend to be concentrated in one
quadrant and therefore they will not undergo stratified recruitment. Comparison of
continuous data between groups will be performed using t-tests or one-way analysis of
variance as appropriate. Comparison of proportions will be analyzed using χ2. We will
compare prevalence data between the racial groups with respect to GERD and the functional
bowel diseases. A logistic regression will be performed to determine risk factors for these
diseases. Race will be a pre-specified predictor variable along with those factors found
significant (P< 0.05) on the univariate analysis. Model reduction will be performed using
step-wise methodology. We will look at gender as a possible effect modifier. The results
will provide odds ratios along with their respective 95% confidence intervals. We will
calculate the population attributable risk (PAR) for significant independent variables from
the regression analysis.

Inclusion Criteria:

- age over 18

- self-described African American or Caucasian

- lived in zip code for > 3 years

Exclusion Criteria:

- newly arrived to zip code

- unable to provide proof of address

- unwilling to come to temple to complete interview