Gen IC Form_HINTS-FDA

GENERIC SUB-STUDY SUBMISSION – 0925-0589-06

DATE OF REQUEST: 9/4/2013

SUB AGENCY (I/C): NIH/NCI/DCCPS/BRP

TITLE OF SUB-STUDY: “Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument”

GENERIC CLEARANCE UNDER OMB #0925-0589-06 EXP. DATE: 4/30/2014

TOTAL BURDEN APPROVED: 6,000 hours

BURDEN APPROVED TO DATE: 305 hours

BURDEN FOR THIS REQUEST: 58 hours

ABSTRACT:

Cognitive testing of the planned HINTS-FDA questionnaire is essential to identify problems in question wording, context or order effects, as well as response difficulties resulting from the design and layout of the mail form. Although NCI is working towards having a full HINTS-FDA data collection effort (with OMB approval), the results of the proposed cognitive testing will facilitate improvements to both the questions and the design of the questionnaire for use by any Federal agency. The HINTS team has coordinated efforts with other Federal partners to inform the development of the instrument to be tested and has explored CDC’s Q-Bank database of cognitive testing reports (http://wwwn.cdc.gov/qbank/home.aspx). Of the 40 tobacco-related items to be tested, 90% of the items are new and have never been included on any other Federal survey. The other 10% (n=4) are modified versions from other surveys and have not been tested or fielded in the proposed form. Participants for the proposed cognitive interviews will be recruited from the non-institutionalized adult household population. Ten of the 35 cognitive interviews will be conducted with adults who speak primarily Spanish at home. All cognitive interviews will be done in person and each will take 90 minutes. A semi-structured protocol for conducting the cognitive interviews will be used which focuses primarily on comprehension issues with those questions new to the HINTS-FDA.

IS RACE AND ETHNICITY DATA COLLECTED AS REQUIRED? ___X___YES _____NO_______N/A	IS PERSONALLY IDENTIFIABLE INFORMATION (PII) BEING COLLECTED? ___X___YES _____NO_______N/A
OBLIGATION TO RESPOND: __X___ VOLUNTARY ______ REQUIRED TO OBTAIN OR RETAIN BENEFITS ______ MANDATORY	TYPE OF COLLECTION/RESEARCH? _____ CUSTOMER SATISFACTION _____ USABILITY TESTING _____FOCUS GROUPS _____PRETESTING _____FORMATIVE RESEARCH __X___QUESTIONNAIRE DEVELOPMENT _____ OTHER: _________________________
HOW WILL THIS SURVEY BE OFFERED? _____ WEB SITE __X___ TELEPHONE INTERVIEW (screener) _____ MAIL RESPONSE __X___ IN PERSON INTERVIEW (cognitive interviewing) _____ OTHER: _________________________
CONTACT INFORMATION: NAME: Bradford Hesse TELEPHONE NUMBER: 240-276-6721 EMAIL ADDRESS: [email protected]