Draft Risk Disclosure Study Questionnaire - FDA Tv & Radio Ads

8/13/2019 Draft Risk Disclosure Study Questionnaire - FDA Tv & Radio Ads

1/15

December 23, 2013

DRAFT Questionnaire

Programming instructions are indicated in green font.

[PROGRAMMER: Program progresses to te !uestioning in a "one#$a%& manner Record time in mi''iseconds spent on eac screen (inc'uding !uestions) trougout protoco'.

[PROGRAMMER: Te OM* contro' num+er and E,piration Date sou'd appear at te +ottom ofe-er% screen (ma%+e a+o-e te pri-ac% te,t). t sou'd +e as uno+trusi-e as possi+'e.After te first screen (/onsent 0creen 1)2 $e so$:

D330 researc autori4ed +% 0ection 1561(a)(7) of te Pu+'ic 3ea't 0er-ice Act (78 9.0./.66u(a)(7)). /onfidentia'it% protected +% ; 9.0./. ;;8(a) and (+) and 81 /FR part 86. OM*/ontro' 16#,,,,== E,pires ,,?,,?,,

For e-er% oter screen $e $i'' so$:OM* /ontro' 16#,,,,==== E,pires ,,?,,?,,===@

PROG: (/90TOM TERMATO) FOR TERMATED PART/PAT0:

Bm sorr%2 +ut %ou are not e'igi+'e for tis stud%. Tere are man% possi+'e reasons $% peop'e are note'igi+'e. Tese reasons $ere decided ear'ier +% te researcers. TanC %ou for %our interest in tisstud% and for taCing te time to ans$er our !uestions toda%.@

[/onsent 0creen 1@

ou are +eing asCed to participate in a sur-e% a+out ne$ consumer products. f %ou agree to taCe pain tis researc2 %ou $i'' +e asCed to $atc a T ad a+out a prescription drug and ans$er some!uestions a+out tat drug. Te stud% $i'' taCe a+out 6 minutes.

[nsert 'anguage a+out pane' points?re$ards@

[nsert 'anguage a+out pane' pri-ac% po'ic%@

D330 researc autori4ed +% 0ection 1561(a)(7) of te Pu+'ic 3ea't 0er-ice Act (78 9.0./.66u(a)(7)). /onfidentia'it% protected +% ; 9.0./. ;;8(a) and (+) and 81 /FR part 86.

OM* /ontro' 16#,,,,==== E,pires ,,?,,?,,=====

[PROGRAMMER: 0creen 1. TME 0PET O 0/REE M0E/OD0@

OM* /ontro' < ===== E,pires ===


2/15

0/REEG Q9E0TO0

01. Are %ou at 'east 1 %ears o'dH

es continue o terminate and so$ custom termination screen

08. n $at %ear $ere %ou +ornH ======

f ear is I or J 1>>K continuef ear is L 1>>K terminate and so$ custom termination screen

DO OT READ Prefer not to ans$er terminate and so$ custom termination screen

0a. 3as a doctor or oter ea'tcare pro-ider e-er said %ou a-e an% of te fo''o$ing ea'tpro+'emsH

a. Astma =====es =====o [fi''er@+. Dia+etes =====es =====o [fi''er@c. nsomnia =====es =====od. 3ig co'estero' =====es =====oe. Acid ref'u, or GERD =====es =====o [fi''er@f. Depression =====es =====o0+. n $at %ear $ere %ou diagnosed $it tat conditionH

ear (enter a num+er)

nsomnia

3ig /o'estero'

Depression

[ PROGRAMMER: f "no& to 0ac2 asC 07.@

07. 3a-e %ou ad an% of te fo''o$ing ea't s%mptoms for te past mont: [randomi4e@

a. Trou+'e fa''ing as'eep =====es =====o+. Di44iness =====es =====o [fi''er@c. Trou+'e sta%ing as'eep =====es =====od. ot fee'ing rested $en %ou $aCe up=====es =====oe. um+ness or ting'ing in %our 'egs =====es =====o [fi''er@f. Fre!uent eart+urn =====es =====o [fi''er@



3/15

[Programmer: Must sa% %es to (07a AND07c AND07d) OR%es to 0ad OR yes to S3ac OR %es to0af to continue te sur-e%.@

0;. Are %ou trained or emp'o%ed as a ea't care professiona'H

es terminate and so$ custom termination screen

o continue

0K. Do %ou $orC for a parmaceutica' compan%2 an ad-ertising agenc%2 or a marCet researccompan%H

es terminate and so$ custom termination screen

o continue

[PROGRAMMER: 0creen 1. TME 0PET O 0/REE M0E/OD0@

TanC %ou for agreeing to participate in tis stud% toda%.

MaCe sure %ou are comforta+'e and can read te screen from $ere %ou sit. Tis stud% is a+out

ad-ertising for prescription drugs. e $i'' so$ %ou an ad for a prescription drug and ten asC %ou

some !uestions a+out it. our ans$ers are pri-ate and $i'' not +e connected $it %our name. our

input is e,treme'% -a'ua+'e.

[PROGRAMMER: 0creen 8. TME 0PET O EA/3 0/REE M0E/OD0@

etBs +egin.

e $i'' asC %ou !uestions a+out te ad after %ou a-e finised $atcing it. Do %our +est to remem+

detai's a+out te ad. e $i'' asC %ou to e,p'ain %our ans$ers. MaCe sure %our computer sound is

turned on and set at a comforta+'e -o'ume.

[e,t page@

QP1. Did %ou read te instructionsH

es

oterminate and so$ custom termination screen

[PROGRAMMER: 0o$ stimu'i t$ice. n +et$een -ie$ings2 te fo''o$ing te,t sou'd appear: "o$atc te ad again.&@



4/15

P'ease ans$er te fo''o$ing !uestions +ased on te ad %ou sa$.

Q1a. ere %ou a+'e to -ie$ te ad for [DR9G@Hes

o[0Cip +acC to ad@

ot sure[0Cip +acC to ad@

[PROGRAMMER: f Q1Jo or ot sure2 sCip +acC to te ad2 and 'et tem tr% again. f2 after tis2te% sti'' sa% o or ot sure to Q12 ten terminate.@

Q1+. P'ease 'ist te tougts tat $ere going troug %our mind as %ou -ie$ed te ad for [DR9G@and 'ist tem +e'o$. 9se one 'ine for eac tougt.

[PROGRAMMER: Fi-e separate te,t +o,es@

Q8. at Cind of product is Drug X? [PROGRAMMER: randomi4e responses@

=====Prescription drug=====O-er#te#counter (OT/) drug=====3er+a'?Dietar% supp'ement=====DonBt Cno$

Q. at condition does [DR9G@ treatH [PROGRAMMER: randomi4e responses@

3ig +'ood pressurensomniaMigraine eadaces3ig /o'estero'Dia+etesAcid Ref'u,?GERDDepressionDonNt Cno$ or uncertain



5/15

Q7. at are te +enefits of [DR9G@H 9se one 'ine for eac +enefit %ou 'ist. [Open#ended@[PROGRAMMER: Fi-e separate te,t +o,es@

Q;. at are te risCs of [DRUG]? 9se one 'ine for eac risC %ou 'ist. [Open#ended@[PROGRAMMER: Fi-e separate te,t +o,es@

[PROGRAMMER: MAT/3 ER0O OF QK TO D0EA0E AD 03O@

(Memor% for +enefits and risCs)

K=1. *ased on te information in te ad2 p'ease cecC $ic of te fo''o$ing are +enefits or risCs oftaCing [DR9G@. [Depression -ersion@

[PROGRAMMER: randomi4e a#'@

es o

a.

+.

c.

d.



6/15

e.

f.

g.

.

i.

.C.

'.

K=8. *ased on te information in te ad2 p'ease cecC $ic of te fo''o$ing are +enefits or risCs oftaCing [DR9G@. [nsomnia -ersion@


es o

a.

+.c.

d.

e.

f.

g.

.

i.

.

C.

K=. *ased on te information in te ad2 p'ease cecC $ic of te fo''o$ing are +enefits or risCs oftaCing [DR9G@. [3ig co'estero' -ersion@


es o

a.

+.

c.

d.

e.

f.

g.

.

i.

.

C.



7/15

'.

(Percei-ed *enefit)

[PROGRAMMER: Participants can s'ide an arro$ to teir ans$er.@

Q5. n %our opinion2 if 166 peop'e taCe [DRUG]2 for $at percentage of peop'e $ou'd te drug $orC

Q. n %our opinion2 if [DR9G@ did e'p a personBs [condition@2 o$ muc $ou'd it e'pH

(Percei-ed RisC)

Q>. n %our opinion2 if 166 peop'e taCe Drug X2 $at percentage of peop'e $i'' a-e an% side effectsor negati-e outcomesH&

Q16. n %our opinion2 if [DR9G@ did cause a person $it [condition@ to a-e side effects or negati-eoutcomes2 o$ serious $ou'd te% +eH


1 8 7 ;

ou'd e'pDisease

a 'itt'e

ou'd e'pDisease

a 'ot


8/15

Q11. *ased on te information in tis ad for [DR9G@2 o$ eas% or difficu't is it to treat [condition@

er% Difficu't0ome$at difficu'teiter difficu't or eas%0ome$at eas%er% eas%

Q18. TinCing o-era'' a+out te risCs and +enefits of [Drug]2 $ou'd %ou sa% it as:

1 8 7 ;Man% more risCs

tan +enefits

0ome$at more

risCs tan

+enefits

E!ua' risCs and

+enefits

0ome$at more

+enefits tan

risCs

Man% more

+enefits tan

risCs

[PROGRAMMER: counter+a'ance 1#17 and 1;#1K@

Q1. f someone $it [condition@ sa$ tis ad2 o$ 'iCe'% $ou'd tat person +e to asC teir doctora+out [Drug@H

1 8 7 ;er% un'iCe'% 0ome$at

un'iCe'%

eiter 'iCe'%

nor un'iCe'%

0ome$at 'iCe'% er% 'iCe'%

Q17. f someone $it [condition@ sa$ tis ad2 o$ 'iCe'% $ou'd tat person +e to 'ooC for moreinformation a+out [Drug@H

1 8 7 ;

er% un'iCe'% 0ome$atun'iCe'%

eiter 'iCe'%nor un'iCe'%


Q1;. f someone $it [condition@ sa$ tis ad2 o$ 'iCe'% $ou'd tat person +e to 'ooC for moreinformation a+out [condition@H

1 8 7 ;er% un'iCe'% 0ome$at eiter 'iCe'% 0ome$at 'iCe'% er% 'iCe'%


1 8 7 ;

ot at a'' serious er% serious


9/15

un'iCe'% nor un'iCe'%

Q1K. f one of %our fami'% mem+ers ad [insert disease condition@2 o$ 'iCe'% $ou'd %ou +e tomention Drug to temH

1 8 7 ;er% un'iCe'% 0ome$at

un'iCe'%

eiter 'iCe'%

nor un'iCe'%


Q15. 3o$ persuasi-e is tis adH

1 8 7 ;ot at A''

Persuasi-e

er%

Persuasi-e

[PROGRAMMER: Rotate order of Q1#Q1>@

(Percei-ed /omparati-e *enefit and RisC)

Q1. [DR9G@ is more effecti-e tan oter medicines tat treat [[email protected]'% agree0ome$at agreeeiter agree nor disagree0ome$at disagree

0trong'% disagree

Q1>. [DR9G@ is safer tan oter medicines tat treat [[email protected]'% agree0ome$at agreeeiter agree nor disagree0ome$at disagree0trong'% disagree

[PROGRAMMER: Randomi4e order of Q86a#c. Record time spent on series.@

(RisC?*enefit Tradeoff)

Q86. P'ease rate %our agreement or disagreement $it eac of te fo''o$ing statements.

0trong'%agree

0ome$atagree

eiteragree nordisagree

0ome$atdisagree

0trong'%disagree

a. Te ad c'ear'%



10/15

communicated te benefitsof [DR9G@.

+. Te ad c'ear'%communicated te risksof[DR9G@.

c. Te ad e-en'% +a'anced terisks and benefitsof[DR9G@.

(*ea-iora' ntention)

Q81. 3o$ 'iCe'% or not 'iCe'% are %ou to 'ooC for more information a+out [DR9G@H

er% un'iCe'%0ome$at un'iCe'%

eiter un'iCe'% nor 'iCe'%0ome$at 'iCe'%er% 'iCe'%

Q88. 3o$ 'iCe'% or not 'iCe'% are %ou to tr% [DR9G@H

er% un'iCe'%0ome$at un'iCe'%eiter un'iCe'% nor 'iCe'%

0ome$at 'iCe'%er% 'iCe'%

(Percei-ed Qua'it%)Q8. 3o$ $ou'd %ou rate te !ua'it% of [DR9G@H

1 ####### 8####### ####### 7 ####### ; ######## K ######## 5Poor !ua'it% Good !ua'it%

[PROGRAMMER: Randomi4e order of Q87a#c@(Attitude to$ard Ad. From *utada et a'.2 866>2 0en /en2 86652 and MacSen4ie ut42 1>>)

Q87. n %our opinion2 $as te ad for [Drug@:

a. 1 8 7 ; K 5 Good *ad



11/15

+. 1 8 7 ; K 5 P'easant 9np'easant

c. 1 8 7 ; K 5 Fa-ora+'e 9nfa-ora+'e

(Manipu'ation /ecCs)

Q8;. 3o$ muc attention did %ou pa% to te ad $en %ou $ere $atcing itH

1 8 7 ; A 'itt'e A 'ot

Q8K. Do %ou remem+er seeing a statement sayng t!at t!e "u## #st o" rs$s an% s%e e""ects &as no'resente%in te ad for [DR9G@H

esoot sure

[TROD9/TO:@o$ $e $i'' so$ %ou te ad again. Tis ad ad a statement sayng t!at t!e"u## #st o" rs$s an% s%e e""ects &as not 'resente%for [DR9G@. en ans$ering te ne,t fe$!uestions2 p'ease tinC on'% a+out tis statement.

[/ontro' conditions do not see ad again and sCip to Q8>@

en ans$ering te ne,t fe$ !uestions2 p'ease tinC on'% a+out te statement about t!e "u## #st o"rs$san% s%e e""ectsmentioned in te ad.

(nferences a+out 0tatement)

Q85a. n %our o$n $ords2 'ist a'' %our tougts2 reactions and ideas tat $ent troug %our mind$en %ou eard te statement2 "Tis is not a fu'' 'ist of risCs and side effects. Ta'C to %our doctor anread te patient 'a+e'ing for [DR9G@& in te ad for [DR9G@. P'ease use a separate 'ine for eactougt.

[PROGRAMMER: Fi-e separate te,t +o,es@



12/15

Q85+. For eac of te tougts2 reactions and ideas %ou 'isted2 indicate $eter te tougt $aspositi-e2 negati-e or neutra'.[PROGRAMMER: Disp'a% responses from Q85a. For eac response2 inc'ude a drop#do$n coice +oor oter appropriate coice +o, $it te coices PO0TE2 EGATE2 E9TRA@

ou said s it

[insert eac response from Q8a a+o-e in aseparate +o,@

PO0TEEGATEE9TRA

(Peripera' /ue)

Q8. To $at e,tent do %ou agree or disagree tat te statement about t!e #st o" rs$s an% s%ee""ects$as:

0trong'%agree

0ome$atagree

eiteragree nordisagree

0ome$atdisagree

0trong'%disagree

a. oticea+'e

+. *e'ie-a+'e

c. Distracting

[P'aceo'der for !uestion(s) a+out opening framing statement@[PROGRAMMER: P'ace Q8>a andQ8>+ on same screen. A'so p'ace Q8>c and Q8>d on same screen. Ten randomi4e order of tese t$screens (Q8>a#+ and Q8>c#d). itin eac screen $e need to randomi4e te order of te !uestionso$n@

(0Cepticism)

Q8>a. 3o$ 'iCe'% is it tat te +enefits of te drug are trueH

1 8 7 ; K 5 >ot at a'' E,treme'%



13/15

iCe'% iCe'%

Q8>+. 3o$ sCeptica' are %ou a+out te trut of te +enefits of te drugH

1 8 7 ; K 5 >ot at a'' E,treme'%0Ceptica' 0Ceptica'

Q8>c. 3o$ 'iCe'% is it tat te risCs of te drug are trueH

1 8 7 ; K 5 >ot at a'' E,treme'%iCe'% iCe'%

Q8>d. 3o$ sCeptica' are %ou a+out te trut of te risCs of te drugH

1 8 7 ; K 5 >ot at a'' E,treme'%0Ceptica' 0Ceptica'

(0u+ecti-e 3ea't iterac%)Q6. 3o$ often do %ou a-e someone ('iCe a fami'% mem+er or friend) e'p %ou read instructions2pamp'ets2 or oter $ritten materia' from %our doctor or parmac%H

1 8 7 ;e-er Occasiona''% 0ometimes Often A'$a%s

Q1. 3o$ confident are %ou fi''ing out medica' forms +% %ourse'fH

1 8 7 ;ot at a''

confident

A 'itt'e +it 0ome$at Quite a +it E,treme'%

confident

o$ a fe$ !uestions to e'p us descri+e our samp'e of participants.

Q8. n genera'2 o$ muc do %ou fee' %ou Cno$ a+out [condition@H

A 'otA good +it0omeOn'% a s'igt amountoting at a''



14/15

Q. n genera'2 o$ muc do %ou fee' %ou Cno$ a+out treatmentsfor [condition@H

A 'otA good +it

0omeOn'% a s'igt amountoting at a''

Q7. Are %ou current'% taCing an% prescription drugs for [condition@H=====es (continue to Q;)=====o (sCip to QK)

Q;. 3o$ 'ong a-e %ou +een taCing prescription drugs for [condition@H

=====ess tan 8 $eeCs

=====At 'east 8 $eeCs +ut 'ess tan 8 monts=====At 'east 8 monts +ut 'ess tan K monts=====At 'east K monts +ut 'ess tan 1 %ear=====At 'east 1 %ear +ut 'ess tan ; %ears=====At 'east ; %ears

QK. at did %ou use to comp'ete toda%Bs sur-e%Haptop computer ? et+ooC computerDesCtop computer3ande'd pone (iPone2 *'acC+err%2 Droid)3ande'd de-ice oter tan a pone (iPod Touc2 Pa'm Pi'ot2 iPad)Oter: ================

Q5. Are %ou no$ co-ered +% an% form of ea't insurance or ea't p'anH Tis inc'udes an%pri-ate insurance p'an troug %our emp'o%er or a p'an tat %ou purcased %ourse'f2 as $e'' as ago-ernment program 'iCe Medicare or Medicaid.

eso (0Cip to QD1)DonBt Sno$

Q. Does %our current insurance p'an e'p pa% for prescription drugsHesoDonBt Sno$

QD1. at is %our genderH

Ma'eFema'e

QD8. at is te igest 'e-e' of scoo' %ou a-e comp'eted or te igest degree %ou a-e



15/15

recei-edH

ess tan ig scoo'3ig scoo' graduateUig scoo' dip'oma or te e!ui-a'ent (for e,amp'e: GED)0ome co''ege +ut no degreeAssociate degree in co''ege

*ace'orBs degree (for e,amp'e: *A2 A*2 *0)Ad-anced or post#graduate degree (for e,amp'e: MasterBs degree2 MD2 DD02

VD2 PD2 EdD)

QD. Are %ou:3ispanic or atino

ot 3ispanic or atino

QD7. at is %our raceH ou ma% se'ect one or more races.

W American ndian or A'asCa ati-e

W AsianW *'acC or African AmericanW ati-e 3a$aiian or oter Pacific s'anderW ite

QD;. at is %our ouseo'd incomeH

=====ess tan X62666 per %ear=====X62666 # X5;2666 per %ear=====X5;2661 # X1;62666 per %ear=====X1;62661 per %ear

[End time: =================== @

ou a-e +een -er% e'pfu'. TanC %ou -er% muc for %our participationY

Te purpose of tis researc is to 'earn a+out consumer reactions to prescription drug ad-ertising. norder to get %our rea'istic reaction to tis information2 $e used a rea' product. P'ease see %ourea'tcare professiona' for !uestions a+out [condition@.

ED


Documents

Draft Risk Disclosure Study Questionnaire - FDA Tv & Radio Ads