B.  	SURVEY APPROACH

INTRODUCTION

This study approach is designed such that it includes the entire
population of beachgoers at each study site.  This includes swimmers and
nonswimmers of all ages with the exception of unaccompanied minors
(since an adult is necessary to provide informed consent).

Survey Objectives and Key Variables

The objective of this study is to conduct health effects studies to
evaluate exposure to water quality indicators in recreational waters and
their subsequent relationship to health effects.  The beaches will be
chosen to consider a range of exposures.  There are four key variables
considered in this study; health status, water quality measures,
environmental exposures and potential confounders.  Each of these
variables is considered in the development of the study objectives.

Health status of the respondents includes health symptoms experienced
prior, during, and after the beach visit (10-12 days after).  Such
symptoms include: diarrhea, vomiting, sore throat earache, eye
infection, rash, sunburn, and fever. 

Water quality measures will be collected in the same beach areas on the
same days as the health data collection.  

Environmental exposures include activities in the designated beach area.
 These include digging in the sand, swimming in the water, snorkeling,
collecting seashells, or length of time in the water.

Potential confounders are possible other symptom determinants that are
not related to the environmental exposure of interest (coastal
recreational water).  These include demographic factors such as age,
sex, race, and specific behaviors such as contact with animals,
consumption of specific foods and contact with other types of water. 

Survey Design

The health survey is administered by bilingual interviewers
(English-Spanish) in three parts: enrollment, exit interview, and
telephone interview.  Both the enrollment and the exit interviews are
completed at the beach.  A second interview is completed by calling the
family at home.

Beach Interview:  The enrollment (Part A) is done shortly after the
family settles in the beach area.  This part of the questionnaire
provides the EPA with information about household health status and it
also limits the amount of time the participants must spend on the
interview as they are leaving the beach.  Part A of the questionnaire
obtains individual-level information on health status and potential
confounders such as age, sex, race, ethnicity, housing characteristics,
family characteristics, and behaviors.  Part B (exit beach interview)
captures data about potential exposures.  The information collected
includes the day’s activities, food and water consumption, potential
water exposure (extent, time, duration, and location), and other
potential confounders. 

Telephone interview:  Study participants are contacted by phone 10 to 12
days after visiting the beach. An adult caregiver, preferably the same
one interviewed at the beach, is asked a series of questions about
family members’ swimming activities, other exposures, health status,
and the severity of any illnesses reported since the initial beach
visit.  Questions cover enteric and nonenteric illness (GI, respiratory,
ear, eye, skin irritations, and urinary tract infections).

  SEQ CHAPTER \h \r 1  

Pretests, Pilot Tests

The beach interview is based on previous questionnaires used in the
studies conducted by EPA in the 1970s and 1980s.  These questions have
been compared to and when possible modifications made to be compatible
with the Centers for Disease Control and Prevention, National Center for
Infectious Diseases FoodNet survey.  In addition, similar questions have
been used in drinking water studies (ref Payment 1, Payment 2, Calderon,
Colford).  Respiratory symptoms have been adapted from the Epidemiology
Standardization Project of the American Thoracic Society and the
Division of Lung Diseases.  Also, the questionnaire was evaluated after
the beach pilot study in 2002.  Modifications of the questionnaire
wording were made based on that experience.  Between the years of 2003
and 2007, the questions were minimally altered to resolve participation
comprehension due to language culture.  Other questionnaire changes are
submitted each year the study is conducted to the Office of Management
and Budget (OMB).  It is anticipated that questionnaire modifications
after this date will not vary from the current format.

	

Collection Methods

The study is a prospective cohort   SEQ CHAPTER \h \r 1 study. Trained
interviewers disperse on the beach and visually identify households
eligible to participate.  The goal is to approach and offer enrollment
to all beach-goers between 11:00 a.m. and 5:00 p.m.  Interviewers
approach beach-goers on weekends and holidays during the recreational
season (Generally April to mid September depending on the geographic
location).  An adult (age 18 or older; 19 in Alabama) answers questions
for other household members.  All contacts on the beach are given either
a flag or colored tape to signify they have been approached to avoid
repeatedly disturbing them.  Respondents are given an inexpensive gift
(cooler or tote bag) following completion of the exit interview. 

Consent process:  The study protocol and questionnaire were reviewed by
the Institutional Review Board (IRB) for the Centers for Disease Control
and Prevention and approved by the EPA Human Subjects Review Official. 
A waiver of written informed consent for the enrollment process was
obtained.

Consent brochure:  This document serves as the verbal consent form and
included information about the benefits of participation (incentives and
public health improvements for beach users), potential disadvantages of
participation (time), absence of health risk, confidentiality,
information dissemination, contact information for investigators, IRB,
and contractor (email address, telephone number, and a website for the
project).  Study participation is completely voluntary and the
participant may withdraw at any time and refuse to answer any individual
questions.

Incentives:  Incentives are provided to participants to encourage
completion of the beach questionnaire on enrollment day (e.g., tote bag,
cooler, or beach-related item). Upon completion of the follow-up
telephone interviews, a $25 check is issued to each household. 

Eligibility criteria:  Potential enrollees had to meet the following
criteria:

1) have a household member legal age to participate (generally at least
age 18), 

2) participate in the study and complete the telephone interview, 

3) have not participated in the study within the prior 28 days.    

Quality control:  EPA developed and implements a Quality Assurance
Project Plan prior to the conduct of any data collection.  In addition,
EPA sends a Quality Assurance Team to perform a Technical Systems Review
at each beach to assure the plan was being adhered to and also to review
procedures carried out at the beach. 

Data entry, management, and security: A computer-assisted personal
interview device (CAPI) equipped with a template of the questionnaire is
used to collect the information at the enrollment and exit interviews. 
This device is a lightweight, hand-held tablet computer tolerant of
extreme environmental conditions.  The CAPI program flags missing items
prior to terminating the interview and also flags erroneous responses to
allow the interviewer to obtain the correct information while
interviewing the household.  All data are kept in locked cabinets or in
password-protected computers.  All data is removed from the computers
daily and they are always secured at the beach site.  Networks are
protected with a firewall to prevent unauthorized access to agency
networks.  Personal identifying information is stored separately from
questionnaire and telephone survey information, and all personal
information was removed from analytical databases.  Following completion
of the final follow-up survey at the end of the study, participant
personal identifiers were unlinked from the data. 

The phone interview is conducted using a similar program and a
computer-assisted telephone interview (CATI) system.  The CATI system
automatically flags missing or erroneous data prior to termination of
the interview.  Telephone interviews are conducted from secured research
facilities.  Each of these devices reduces data entry errors that result
from data transfer in traditional paper-based studies.

Paper Reduction Act:  The questionnaires and study protocol were
published in the Federal Register and public comment was requested.  The
comments and the estimated burden of the questionnaire were reviewed and
approved by the Office of Management and Budget.  The OMB number for
this study is 2080.0068.

Analyzing Survey Results

The primary goal of the data analysis is to evaluate the relationship
between novel and rapid measures of water quality and health effects and
determine whether the new approaches to measuring water quality would be
useful in protecting beach-goers health.  If these methods prove to be
useful, then they have potential to be used in criteria and guideline
development.  A second goal is to conduct subgroup analysis on
particular sensitive subpopulations such as children and the elderly.

Analyses will be conducted by comparing gastrointestinal and other
health symptoms by swimming and non-swimming status and by exposure to
varying levels of water quality measures.  

At the completion of the entire program, an overall report will be
produced that synthesizes all the information.  An EPA report will be
produced for Agency and public use.  A manuscript for each recreational
season will be submitted for publication in a peer-reviewed scientific
journal.

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