Evidence map›Paper›PMID 36035636›Full record

ArticleJournal of public policy & marketing : JPP&M : an annual publication of the Division of Research, Graduate School of Business Administration, the University of Michigan2016

An Empirical Examination of the FDAAA-Mandated "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.

Kathryn J Aikin, Amie C O'Donoghue, Claudia Squire, Helen W Sullivan, Kevin R Betts

Abstract read
In one paragraph

Article in Journal of public policy & marketing : JPP&M : an annual publication of the Division of Research, Graduate School of Business Administration, the University of Michigan, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye Tracking Study.Journal of public policy & marketing : JPP&M : an annual publication of the Division of Research, Graduate School of Business Administration, the University of Michigan · 2017
    Article
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

5 authors.

Kathryn J AikinU.S. Food and Drug Administration.
Amie C O'DonoghueU.S. Food and Drug Administration.
Claudia SquireRTI International.
Helen W SullivanU.S. Food and Drug Administration.
Kevin R BettsU.S. Food and Drug Administration.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

We investigated how inclusion of a "toll-free statement" for reporting side effects to FDA in prescription drug direct-to-consumer (DTC) television ads affects comprehension of product risks and benefits, and comprehension of and memory for the toll-free statement itself. Participants viewed one of nine mock prescription drug television ads that varied elements of the toll-free statement, and then responded to a questionnaire. Presenting the statement in both text and audio resulted in better processing of the statement compared to only text. When shown in text alone, presenting the statement during the entire advertisement or after the statement of risks resulted in better processing of the statement compared to placement before the presentation of risk information. The placement, duration, or prominence of the statement did not affect comprehension of product risk and benefit information. Our findings suggest that the toll-free statement can be added to DTC television ads without significantly affecting comprehension of product risk and benefit information, and that select presentations are preferable for communicating the toll-free statement. The appropriate inclusion of the toll-free statement in DTC television ads may increase the visibility of the adverse event reporting system, without any apparent cost to the understanding of benefits and risks.

Indexed as

advertisementsdrug safetyDTCFood and Drug Administration Amendments Actprescription drugsrisk comprehensionrisk perceptiontoll-free statement

Identifiers

PMID36035636
PMCPMC9413021

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.