Evidence map›Paper›PMID 28844621›Full record

Trial reportResearch in social & administrative pharmacy : RSAP2018

Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements.

Kevin R Betts, Vanessa Boudewyns, Kathryn J Aikin, Claudia Squire, Suzanne Dolina, Jennifer J Hayes, Brian G Southwell

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Research in social & administrative pharmacy : RSAP, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Kevin R BettsU.S. Food and Drug Administration, Office of Prescription Drug Promotion, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. Electronic address: kevin.betts@fda.hhs.gov.
Vanessa BoudewynsRTI International, Center for Communication Science, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA. Electronic address: vboudewyns@rti.org.
Kathryn J AikinU.S. Food and Drug Administration, Office of Prescription Drug Promotion, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. Electronic address: kathryn.aikin@fda.hhs.gov.
Claudia SquireRTI International, Center for Communication Science, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA. Electronic address: cms@rti.org.
Suzanne DolinaRTI International, Center for Communication Science, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA. Electronic address: sdolina@rti.org.
Jennifer J HayesRTI International, Center for Communication Science, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA. Electronic address: jhayes@rti.org.
Brian G SouthwellRTI International, Center for Communication Science, 3040 E. Cornwallis Rd., Research Triangle Park, NC 27709, USA. Electronic address: bsouthwell@rti.org.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundBroadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product's major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information.

objectivesExamine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers' ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined.

methodsA web-based experiment was conducted in which US adults who self-reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire.

resultsThe type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias-corrected scores) ranged from 63% to 70% across the three illness samples.

conclusionsThe revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers' processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks.

Indexed as

Direct-to-Consumer AdvertisingRiskAdolescentAdultDepressionFemaleHumansHypercholesterolemiaInternetMaleMental RecallMiddle AgedPatient Education as TopicPrescription DrugsSleep Initiation and Maintenance DisordersSurveys and QuestionnairesPrescription DrugsDirect-to-consumer prescription drug advertisingDisclosuresFood and drug administrationMajor statementPrescription drugsRisk communication

Identifiers

PMID28844621
PMCPMC9476830

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.