Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study

Sullivan, Helen W.; O’Donoghue, Amie C.; Aikin, Kathryn J.

doi:10.1177/2168479015572370

Cited by 28 publications

(46 citation statements)

References 28 publications

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“…While routine measures [ 11 ] are applied to every medicinal product, additional risk minimisation activities are usually only introduced when they are deemed to be essential for the safe and effective use of the medicinal product. Here social media can prove to be an effective communication tool to enrol patients, prescribers, pharmacies and healthcare facilities [ 57 ], e.g. in situations when prescription is only possible as part of a restricted programme or based on the dissemination of disease-specific educational information aimed at patients to better understand their disease and to facilitate engagement with healthcare professionals to improve health outcomes [ 58 ].…”

Section: Discussionmentioning

confidence: 99%

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe

Brosch¹,

Ferran

Newbould³

et al. 2019

Drug Saf

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The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance. As a starting point, a review of existing legal requirements and regulatory guidance on social media use in pharmacovigilance was performed based on a survey conducted in 2014–2015. Furthermore, input from two large stakeholder workshops and evidence gathered from the research performed by WEB-RADR on the analysis of social media data were taken into consideration. Whilst analytical results of WEB-RADR indicated limited value of social media in detecting or confirming signals for a majority of the drugs studied, it is important to establish a regulatory framework for the use of social media in pharmacovigilance. Thus, the screening and reporting of suspected adverse reactions remains an important pillar in monitoring the safety and efficacy of medicines and the identification of new safety issues. Principles as to how social media can be used in pharmacovigilance are absolutely needed to provide clarity to patients, healthcare professionals, medicines regulators and the pharmaceutical industry. Electronic supplementary material The online version of this article (10.1007/s40264-019-00811-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe

Brosch¹,

Ferran

Newbould³

et al. 2019

Drug Saf

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show abstract

“…[4,13,14,19] The inclusion of textual benefit information has been shown to partly address this imbalance, however, the impact of providing numeric benefit information is more complex. [19] There is evidence to support the idea that the risks and benefits of treatments are better understood when presented in a numerical format [20,21] although it is apparent that this is not without impact with patients reporting emotional responses, such as anxiety and unease, about the inclusion of numerical benefit information in PILs. [4,18] While patients report a preference for textual benefit information, it is apparent that the provision of numeric information can encourage more accurate interpretations of risks and benefits.…”

Section: Discussionmentioning

confidence: 99%

How much information about the benefits of medicines is included in patient leaflets in the European Union? – A survey

Dickinson

Raynor

Knapp

et al. 2016

International Journal of Pharmacy Practice

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Introduction Patient information leaflets (PILs) are required with all licensed medicines throughout the European Union (EU) and they must include information about all side effects and their likelihood. This has led to criticism of a lack of balance, with little information included about potential benefits. Recent European Medicines Agency guidance proposed the inclusion of benefit information, and this study examined the current prevalence and type of such information in PILs in the EU. Methods A survey and content analysis of the English translation of PILs in the EUwas carried out. Random quota sampling was used on the most frequently dispensed (n = 50) and newly licensed medicines (n = 50) in 2011/2. Leaflets were searched for benefit information meeting predefined criteria, and data synthesised and categorised into 10 categories. Results Eighty-five (85%) leaflets described how the medicine works, with 45 providing information about the rationale for treatment (more commonly for newly licensed (32/50) than most commonly dispensed medicines (13/50; P < 0.001). Nearly half (47) did not describe whether the medicine was curative, symptomatic or preventative. The terms used to communicate uncertainty were imprecise (such as 'may help'). None communicated numerical benefit information. Conclusion Current PILs do not appropriately communicate information about benefit. At the basic level, around a half did not include information about treatment rationale or whether the treatment was to treat symptoms, curative or preventative. However, for true informed decision making, patients need quantitative information about benefits and none of the leaflets provided this.

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“…Therefore, a summary of all SRs would cause a bias. Categorizing investigated lifestyle interventions showed varying results: Among 6 SRs investigating only dietary advice only one SR with women and a BMI > 25 kg/m2 reported that the intervention significantly reduced GDM in accordance with a sub-analysis of women with a BMI >25 kg/m2 within another publication (30). One SR investigating a low-glycemic index diet found a decreased rate of LGA children (36).…”

Section: Main Textmentioning

confidence: 93%

Time to improve the communication of evidence-based medicine to pregnant women: a review of an exemplary framework related to the prevention of gestational diabetes

Arabin

Behnam

Ellermann

et al. 2019

Preprint

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BACKGROUND Medical specialists are frequently challenged to understand and explain the best evidence even when study results are contradictive. During pregnancy, communication of evidence should motivate women to realize life style changes in favor of themselves and their offspring. MAIN BODY On the topic of prevention of gestational diabetes alone, we found 17 systematic reviews/meta-analyses. Outcomes, reporting and methodological quality differed according to PRISMA, ROBIS and AMSTAR tools. CONCLUSIONS We propose a methodology to select and transform the best evidence into a format illustrating benefits and harms of interventions as fact boxes and icon arrays, which may be applied in other fields of obstetrics.

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Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study

Abstract: The study findings suggest that, for simple drug information, adding absolute frequencies and percentages to direct-to-consumer advertisements may benefit consumers. Absolute differences and qualitative labels may not be needed.

Cited by 28 publications

References 28 publications

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe

How much information about the benefits of medicines is included in patient leaflets in the European Union? – A survey

Time to improve the communication of evidence-based medicine to pregnant women: a review of an exemplary framework related to the prevention of gestational diabetes

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