Users' guide to detecting misleading claims in clinical research reports.
Ontology highlight
ABSTRACT:
SUBMITTER: Montori VM
PROVIDER: S-EPMC526126 | biostudies-literature | 2004 Nov
REPOSITORIES: biostudies-literature
Publications
Users' guide to detecting misleading claims in clinical research reports.
Montori Victor M VM Jaeschke Roman R Schünemann Holger J HJ Bhandari Mohit M Brozek Jan L JL Devereaux P J PJ Guyatt Gordon H GH
BMJ (Clinical research ed.) 20041101 7474
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Project description:BackgroundFalse and misleading advertising for drugs can harm consumers and the healthcare system, and previous research has demonstrated that physician-targeted drug advertisements may be misleading. However, there is a dearth of research comparing consumer-targeted drug advertising to evidence to evaluate whether misleading or false information is being presented in these ads.ObjectiveTo compare claims in consumer-targeted television drug advertising to evidence, in order to evaluate the frequency of false or misleading television drug advertising targeted to consumers.DesignA content analysis of a cross-section of television advertisements for prescription and nonprescription drugs aired from 2008 through 2010. We analyzed commercial segments containing prescription and nonprescription drug advertisements randomly selected from the Vanderbilt Television News Archive, a census of national news broadcasts.Main measuresFor each advertisement, the most-emphasized claim in each ad was identified based on claim iteration, mode of communication, duration and placement. This claim was then compared to evidence by trained coders, and categorized as being objectively true, potentially misleading, or false. Potentially misleading claims omitted important information, exaggerated information, made lifestyle associations, or expressed opinions. False claims were factually false or unsubstantiated.Key resultsOf the most emphasized claims in prescription (n = 84) and nonprescription (n = 84) drug advertisements, 33 % were objectively true, 57 % were potentially misleading and 10 % were false. In prescription drug ads, there were more objectively true claims (43 %) and fewer false claims (2 %) than in nonprescription drug ads (23 % objectively true, 7 % false). There were similar numbers of potentially misleading claims in prescription (55 %) and nonprescription (61 %) drug ads.ConclusionsPotentially misleading claims are prevalent throughout consumer-targeted prescription and nonprescription drug advertising on television. These results are in conflict with proponents who argue the social value of drug advertising is found in informing consumers about drugs.
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Project description:A new type of foods with a health claims notification system, the Foods with Function Claims (FFC), was introduced in Japan in April 2015. This cross-sectional study sought to clarify compliance of clinical trial protocols reported as the scientific basis of efficacy in the FFC system. All articles based on clinical trials published on the Consumer Affairs Agency website from 1 July 2018 to 30 June 2021 were reviewed. Items assessed included first author characteristics (for-profit or academia), journal name, year published, journal impact factor in 2020, article language, name of clinical trial registration (CTR), and seven compliance items (Title: T, Participant: P, Intervention: I, Comparison: C, Outcome: O, Study design: S, and Institutional Review Board, IRB). Among studies that conducted CTR, consistency with these seven compliance items was evaluated. Out of 136 studies that met all inclusion criteria, 103 (76%) performed CTR, and CTR was either not performed or not specified for 33 (24%). Compliance between the protocol and the text was high (≥96%) for items P and S, but considerably lower for items T, I, C, O, and IRB (52%, 15%, 13%, 69%, and 27%, respectively). Furthermore, 43% of protocols did not include functional ingredients or food names in items T or I. The total score was 3.7 ± 1.1 pts (out of 7). Some CTs had no protocol registration, and even registered protocols were suboptimal in transparency. In addition to selective reporting, a new problem identified was that the content of the intervention (test food) was intentionally concealed.
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