Attach1 Examples of methodological studies

PATH Study Generic Clearance for Methodological Studies (NIDA)

Attachment 1
Examples of Methodological Studies to Inform
the PATH Study

Examples of Methodological Substudies to Inform the PATH Study
Example
Web-ACASI Comparison

Background/Purpose
To examine the
equivalence of Web and
ACASI data

Collection of biospecimens
via the mail and in-person

To examine the
equivalence of urine
specimens gathered via the
mail and in-person

Psychometric properties of
PATH Study
Questionnaires

To examine the
psychometric properties,
such as test-retest
reliability, of PATH Study
questionnaires

Comparison of self-reports
with CO or Cotinine

To examine the validity of
self-reported tobacco use
among PATH Study
respondents

Study Design
Probability sample of
adults (non-PATH Study
participants) would respond
by ACASI at time 1, and be
randomly assigned to
respond either by Web or
ACASI at time 2
At follow-up, PATH Study
respondents who provided
a urine specimen at
baseline would be
randomly assigned to
provide a urine specimen
either via the mail or inperson
Probability sample of
adults and youth (nonPATH Study participants)
would be interviewed and
re-interviewed within 1014 days of the initial
interview
Probability sample of
adults (non-PATH Study
participants) would be
interviewed and asked to
provide a urine sample or
breathe into a mechanism
to obtain biomarkers of
tobacco use

Intended Study
Outcome(s)
Brief, cost-efficient,
psychometrically sound
mode of data collection at
follow-up

Brief, cost-efficient,
psychometrically sound
procedures for gathering
urine specimens at followup

Brief, cost-efficient,
psychometrically sound
direct assessment of the
psychometric properties of
data gathered with the
PATH Study
questionnaires
Brief, cost-efficient,
psychometrically sound
assessment of the validity
of data gathered with the
PATH Study
questionnaires