Change Request Justification Memo

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National Panel of Tobacco Consumer Studies

Change Request Justification Memo

OMB: 0910-0815

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National Panel of Tobacco Consumer Studies (OMB Control Number 0910-0815)


Change Request (83-C)


December 28, 2016


The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to incorporate several non-substantive changes to the questionnaires and respondent materials for establishing the panel based on findings and lessons learned from the initial implementation phase.


Overview of the Change Request for OMB Control No. 0910-0815

Between August 18 and October 16, 2016, an initial implementation phase of the National Panel of Tobacco Consumer Studies (TCS) was conducted to test screening and recruitment protocols, field procedures, and respondent materials in advance of the national implementation effort.

There is no change in the burden estimate included in the original clearance request. All changes described in this memorandum and reflected in the attachments were approved by the Institutional Review Board at RTI International (RTI) on November 29, 2016.

Questionnaire Changes

Based on field observations and experiences during the initial implementation phase, minor revisions are requested to the mail screener, field screener, enrollment survey, and baseline survey. These changes include:

  • Addition of FDA logo to the mail screener to be consistent with already approved materials

  • Update to the survey return address on the mail screener

  • Minor edits to introductory and exit script text for improved readability or consistency across panel materials

  • Removal of redundant or unnecessary text or instructions, or corrections to instructions

  • Addition of “Don’t Know” and “Refused” options for all demographic questions

  • Reordering of several questions to improve survey flow

  • Refinements to Spanish translations for several questions

  • Refinements to programming specifications

  • Removal of questions not needed for analysis or screening

Respondent Material Changes

Minor revisions are also requested to the respondent materials based on interviewer feedback:

  • Reformatted and streamlined the doorstep transition script for improved readability by interviewers

  • Added references to “Adult” residents to lead letters and CAPI nonresponse letters; minor cosmetic changes made to the letters to improve readability and emphasize important points in the text to encourage participation

  • Added FDA logo to select respondent materials to be consistent with already approved materials

  • Resolved minor inconsistencies in descriptions of the panel participation requirements across materials

During the initial implementation phase, a number of households refused to begin the screening process at the doorstep, assuming instead that no one in the household was eligible for the panel. Conversion attempts with these and other pending screening and enrollment households are critical to achieving the 4,000-member enrollment target within the allotted schedule and budget. Additional, targeted materials to address specific nonresponse situations are needed. These include:

  • Refusal letters for partial enrollment situations and early doorstep refusals before screening is initiated

  • A screener reminder postcard announcing the interviewer’s upcoming visit

  • Priority letters for pending screening and enrollment cases that inform respondents that the field period is ending soon and their participation is important

  • A controlled access letter for building/property managers to inform them of the interviewer’s visit and request their assistance in providing access to gated communities or controlled-access buildings

Track change documents

Table 1 provides a summary of the non-substantive changes that have been made to the four panel questionnaires: Mail Screener (Attachments 1-1, 2-1); Field Screener (Attachments 1-2, 2-2), Enrollment Survey (Attachments 1-3, 2-3), and Baseline Survey (1-4, 2-4). Table 2 lists the changes that have been made to respondent materials (Attachments 3 and 4). Tracked and clean versions of the English- and Spanish-language questionnaires and respondent materials that have been modified are provided.

Table 1. Summary of Changes to Panel Questionnaires

Questionnaire

Item Number

Page Number*

Addition

Deletion

Edit

Change and Rationale

Prior Approval Given by OMB

Mail Screening Instrument (Attachment 1-1, 2-1)

Logo / Thank You Box

2 (2)



X

Added FDA logo; updated RTI return address

RATIONALE: Consistency with other materials; update address for national survey returns

Base item approved by OMB on 6/8/16

Field Screening Instrument

(Attachments 1-2, 2-2)

SCBINTRO

3 (3)



X

Edited sentence referring to lead letter

RATIONALE: Make it active voice and not imply what respondent should have done/received

Base item approved by OMB on 6/8/16

SCBCONSENT

(4)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

SCC1

(5-6)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

SCC6

7 (8)



X

Added “Refused” response option

RATIONALE: Provide answer choice if screening respondent will not give gender of household members

Base item approved by OMB on 6/8/16

SCC8, SCC9, SCC10, SCC11, SCC12, SCC14

8-10

(8-10)



X

Added “Don’t Know” and “Refused” response options; updated fill logic when gender is missing; refined Spanish translation

RATIONALE: Provide answer choice and updated fill logic if screening respondent will not give active duty status, marital status, education, employment, Hispanic origin, or time spent in home for household members. Improve alignment with English text

Base item approved by OMB on 6/8/16

SCC13

9

(9-10)



X

Added “Don’t Know” and “Refused” response options; updated fill logic when gender is missing

RATIONALE: Provide answer choice and updated fill logic if screening respondent will not give race of household members

Base item approved by OMB on 6/8/16

SCDINTRO

10 (10)



X

Added fill text instruction

RATIONALE: Provide fill when gender is missing

Base item approved by OMB on 6/8/16

SCD2

(11)



X

Corrected Spanish response option 3

RATIONALE: Corrected typo

Base item approved by OMB on 6/8/16

SCD4

(11-12)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

SCE1, SCE6

11-12

(12-13)



X

Updated section header; added “Don’t Know” and “Refused” response options

RATIONALE: Provide answer choice if screening respondent will not provide count of children

Base item approved by OMB on 6/8/16

SCE3, SCE4, SCE5, CHECK BOX 9

12

(12-13)


X


Deleted questions

RATIONALE: Not needed for analysis

Base item approved by OMB on 6/8/16

CHECK BOX 10

13 (13)



X

Added instructions to handle “Don’t Know” and “Refused” responses

RATIONALE: Update sample selection parameters

Base item approved by OMB on 6/8/16

SCEXIT4

14 (14)



X

Revised exit script wording for ineligible households

RATIONALE: Eliminate fill text and simplify scripting given household members may be ineligible for multiple reasons

Base item approved by OMB on 6/8/16

CHECK BOX 11

15 (15)



X

Changed instruction to reference “Enrollment” vs “Baseline” survey

RATIONALE: Correct programming instruction

Base item approved by OMB on 6/8/16

Enrollment Survey (Attachments 1-3, 2-3)

ESINTRO

(17)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

ESA1

17 (18)



X

Reworded question, eliminated “if not obvious”; added “Don’t Know” and “Refused” response options. Refined Spanish translation.

RATIONALE: Item needed for eligibility verification before enrollment begins; provide answer choice if sampled adult will not respond, consistent with field screener. Improve alignment with English text

Base item approved by OMB on 6/8/16

ESA2

17 (18)



X

Added “Don’t Know” and “Refused” response options

RATIONALE: Provide answer choice if sampled adult will not respond, consistent with field screener

Base item approved by OMB on 6/8/16

ESA2a

17

(18-19)



X

Moved item from ESC series to ESA eligibility verification section

RATIONALE: Item needed for eligibility verification before enrollment begins

Base item approved by OMB on 6/8/16

ESA5, ESA6

(19-20)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text; correct translation for smokeless product response option

Base item approved by OMB on 6/8/16

CHECK BOX 3

19 (20)



X

Edited programming instructions; added reference to new disposition codes as needed

RATIONALE: Accommodate “Don’t Know” and “Refused” and active duty military responses

Base item approved by OMB on 6/8/16

ESAEXT1, ESAEXT2,

ESAEXT3, ESAEXT4, ESAALT1, ESAALT2,

ESAALT3

19-21 (21-22)



X

Updated wording of exit scripts; added reference to new disposition codes as needed. Refined Spanish translation.

RATIONALE: Update scripting and codes to match eligibility verification items in ESA1-3; improve alignment with English text as needed

Base item approved by OMB on 6/8/16

ESBINTRO

(22)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

ESB8INTRO

23 (24)



X

Updated reference to number of surveys per year

RATIONALE: Consistency with other materials

Base item approved by OMB on 6/8/16

CHECK BOX 4,

ESB9

23-24 (25)



X

Updated routing and programming instructions

RATIONALE: Correct routing to exit script; delete unnecessary logic

Base item approved by OMB on 6/8/16

CHECK BOX 4A

(26)



X

Deleted check box from Spanish instrument

RATIONALE: Align English and Spanish survey specifications

Base item approved by OMB on 6/8/16

ESBEXT1

24 (26)


X


Deleted exit script

RATIONALE: Not needed per CHECK BOX 4 edit

Base item approved by OMB on 6/8/16

ESBEXT2A

24 (26)



X

Reworded response option 2

RATIONALE: Better identify when sampled adult finds web mode inconvenient

Base item approved by OMB on 6/8/16

ESB12

(28)



X

Removed reference to equipment agreement in Spanish version

RATIONALE: Align English and Spanish survey specifications

Base item approved by OMB on 6/8/16

ESC1

27

(28-29)



X

Added “Don’t Know” and “Refused” response options

RATIONALE: Consistency with other items collecting panel demographics/characteristics

Base item approved by OMB on 6/8/16

ESC2

27 (29)



X

Removed reference to active duty military and full-time/part-time household status

RATIONALE: Items moved to ESA series for eligibility verification

Base item approved by OMB on 6/8/16

ESC4

28 (30)



X

Removed programming instructions

RATIONALE: Not needed

Base item approved by OMB on 6/8/16

ESC4A

28 (30)



X

Deleted fill text

RATIONALE: Not needed for enrollment scripting

Base item approved by OMB on 6/8/16

ESC5

28 (30)



X

Moved item to eligibility verification section (now item ESA2a)

RATIONALE: Item needed for eligibility verification before enrollment begins

Base item approved by OMB on 6/8/16

ESC6, ESC7, ESC8, ESC9, ESC10

29-30 (30-32)



X

Added “Don’t Know” and “Refused” response options

RATIONALE: Consistency with comparable field screening questions

Base item approved by OMB on 6/8/16

ESC11

30 (32)


X


Removed item

RATIONALE: Status in household is collected in item ESA1 in eligibility verification section

Base item approved by OMB on 6/8/16

ESC14

31 (32)

X



Added new question to collect panel member birth month and year

RATIONALE: Track panel member age in future experimental and observational studies

NEW

ESD1

(33)



X

Update interviewer instruction

RATIONALE: Align English and Spanish survey specifications

Base item approved by OMB on 6/8/16

ESD7

(35)



X

Corrected routing instruction

RATIONALE: Align English and Spanish survey specifications

Base item approved by OMB on 6/8/16

ESDEND

(40)

X



Added item

RATIONALE: Align English and Spanish survey specifications

NEW (Spanish)

Baseline Survey (Attachments 1-4, 2-4)

PBINTIT1A

(41)


X


Deleted part of programming instruction

RATIONALE: Align English and Spanish survey specifications

Base item approved by OMB on 6/8/16

PBA1, PBA2, PBA3

(42-43)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

PBB2

(45-46)



X

Corrected numeric range in Spanish version

RATIONALE: Align with English version

Base item approved by OMB on 6/8/16

PBB9

46 (49)



X

Corrected skip in programmer note; updated scripted range probe

RATIONALE: Align with response field range; align English and Spanish versions

Base item approved by OMB on 6/8/16

PBB10A

(50)



X

Added programmer note in Spanish version

RATIONALE: Align with English version

Base item approved by OMB on 6/8/16

PBC1

(54)



X

Refined Spanish translation

RATIONALE: Improve alignment with English text

Base item approved by OMB on 6/8/16

PBC5

52-53 (56)


X


Deleted detailed item on types of Apps used

RATIONALE: Item not needed for analysis or tech support purposes; item PBC4 meets this need

Base item approved by OMB on 6/8/16

*Page numbers in parentheses show the location of the changes in the corresponding Spanish questionnaires.




Table 2. Summary of Changes to Respondent Materials

Material

Attachment

Number

Page Number*

Addition

Deletion

Edit

Change and Rationale

Prior Approval Given by OMB

Screener Lead Letter

3-2. 4-2

2 (2)



X

Added “Adult” to greeting; used bolding in paragraph on what participation involves

RATIONALE: Clarify who the letter is directed to; emphasize important text about survey panel

Item approved by OMB on 6/8/16

Brochure

3-3, 4-3

3-4 (3-4)



X

Revised number of surveys in description of panel participation requirements

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Screener Nonresponse / Unable to Contact Letters

3-4, 3-5, 3-6,

3-7, 3-8, 3-9, 3-10, 4-4, 4-5,

4-6, 4-7, 4-8,

4-9, 4-10

5-11

(5-11)



X

Added “Adult” or NAME fill to greeting; used bolding in paragraph on what participation involves

RATIONALE: Clarify who the letter is directed to; emphasize important text about survey panel

Item approved by OMB on 6/8/16

CAPI Non-Response Letters

3-11, 3-12, 3-13, 3-14, 3-15, 3-16, 3-17, 3-18, 3-19, 3-20, 4-11. 4-12, 4-13, 4-14, 4-15, 4-16, 4-17, 4-18, 4-19, 4-20

12-21

(12-21)



X

Added “Adult” to greeting; used bolding in paragraph on what participation involves

RATIONALE: Clarify who the letter is directed to; emphasize important text about survey panel

Item approved by OMB on 6/8/16

Mail/Web Topical Survey Nonresponse Letter

3-22, 3-24,

4-22, 4-24

22-23

(22-23)



X

Added FDA logo alongside TCS logo

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Web/Mail/Tablet Consent Forms

3-25, 3-26,

4-25, 4-26

24-25 (24-27)



X

Revised reference to number of surveys per year

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Tablet Equipment Agreement

3-27, 4-27

26

(28-29)



X

Updated tablet model

RATIONALE: Match model specifications of final tablet selection

Item approved by OMB on 6/8/16

Doorstep Transition Script

3-30, 4-30

27-29

(30-32)




X

Simplified wording and updated reference to number of surveys per year; split into screening, enrollment, and device options sections

RATIONALE: Reduce verbiage, improve formatting for improved interviewer readability; consistency with other materials

Item approved by OMB on 6/8/16

Incentive Thank You Letter

3-32, 4-32

30 (33)



X

Added FDA logo alongside TCS logo

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Mail Reminder Postcard

3-35, 4-35

31 (34)



X

Added FDA logo alongside TCS logo

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Topical Mail/Web Reminder Postcard

3-38, 3-39,

4-38, 4-39

32-33 (35-36)



X

Added FDA logo alongside TCS logo

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

TCS Panel Member Alert Non-Response Scripts

3-41, 4-41

34-42 (37-43)



X

  • Added “Heads-Up” Announcements scripts by contact mode

  • Reduced characters in post-enrollment automated Text messages

  • Added reminder about frequency of survey requests and additional methods for contacting RTI or updating contact information

RATIONALE: Announce upcoming topical study request to confirm contact information; reduce length of text messages to meet SMS messaging requirements across multiple carriers; remind panelists of expected survey frequency and all means of maintaining contact with RTI

Item approved by OMB on 6/8/16

Website Screens

3-43, 4-43

51

(50-51)



X

Updated reference to number of surveys per year

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Disenrollment Letters

3-44, 3-45, 4-44, 4-45

56-57

(56-57)



X

Added FDA logo alongside TCS logo

RATIONALE: Consistency with other materials

Item approved by OMB on 6/8/16

Screener Nonresponse Priority Letter

3-46, 4-46

58 (58)

X



Added letter to prompt screening participation before field period ends

RATIONALE: Encourage participation in field screening before end of data collection period

NEW

CAPI Nonresponse Priority Letter

3-47, 4-47

59 (59)

X



Added letter to prompt enrollment survey participation before field period ends

RATIONALE: Encourage eligible sampled adult’s enrollment before end of data collection

NEW

Screener Nonresponse Postcard

3-48, 4-48

60 (60)

X



Added postcard to announce upcoming interviewer visit

RATIONALE: Encourage participation in field screening when interviewer visits household

NEW

Screener Nonresponse Letter – Eligibility Determination Needed

3-49, 4-49

61 (61)

X



Added letter to convert early doorstep refusals

RATIONALE: Encourage household to answer screening questions to determine panel eligibility

NEW

CAPI Nonresponse Partial Enrollment Follow-up Letter

3-50, 4-50

62 (62)

X



Added letter to respond to partial enrollments

(enrollment process begun but not completed)

RATIONALE: Encourage sampled adult to complete remainder of enrollment process

NEW

Controlled Access Letter

3-51

63

X



Added letter to property managers in controlled access/gated community situations (English only)

RATIONALE: Inform property management of interviewer’s visit to property and request access; sampled address/unit not identified in letter

NEW

*Page numbers in parentheses show the location of the changes in the corresponding Spanish materials.


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