Dataset Information

How does the side-effect information in patient information leaflets influence peoples' side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England.

ABSTRACT:

Objectives

To establish how the terms recommended by the European Commission to describe side-effect risk in patient information leaflets (PILs) influences expectations of side-effects and to identify factors associated with these side-effect expectations.

Design

A cross-sectional online survey was carried out by a market research company.

Setting

Data were collected in England between 18th March and 1st April 2016.

Participants

A total of 1003 adults aged between 18 and 65.

Main outcome measures

Self-reported expectation that the described side-effects would affect participants if they took the medicine, measured on a likelihood scale from 1 (very unlikely) to 5 (very likely).

Results

Participants formed high expectations of side-effects for "very common" and "common" side-effects, with 51.9% and 45.0% of participants rating these as "very likely" or "likely" to happen to them, respectively. This fell to 8.1% for "uncommon," 5.8% for "rare" and 4.1% for "very rare." For each descriptor, higher expectations of side-effects were more associated with women or being from an ethnic minority, or having less education, a household illness, high perceived sensitivity to medicines or negative beliefs about medicines.

Discussion

The current use of verbal descriptors to communicate side-effect risk in PILs leads to high side-effect expectations. These expectations could contribute to nocebo-induced medication side-effects experienced by patients. Additional work is required to identify ways to improve the way risk information is conveyed in PILs.

SUBMITTER: Webster RK

PROVIDER: S-EPMC5689242 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

How does the side-effect information in patient information leaflets influence peoples' side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England.

Webster Rebecca K RK Weinman John J Rubin G James GJ

Health expectations : an international journal of public participation in health care and health policy 20170615 6

<h4>Objectives</h4>To establish how the terms recommended by the European Commission to describe side-effect risk in patient information leaflets (PILs) influences expectations of side-effects and to identify factors associated with these side-effect expectations.<h4>Design</h4>A cross-sectional online survey was carried out by a market research company.<h4>Setting</h4>Data were collected in England between 18th March and 1st April 2016.<h4>Participants</h4>A total of 1003 adults aged between 18 ...[more]

PMID: 28618140

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Project description:IntroductionEvidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated.ObjectivesThe aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and alternative verbal risk descriptors, in the context of mild and severe side effects.MethodsA cross-sectional online survey was carried out by a market research company recruiting participants aged between 18 and 65 years living in England. Data were collected between 18 March and 1 April 2016. Participants were given a hypothetical scenario regarding the risk of mild or severe medication side effects and asked to estimate how many out of 10,000 people would be affected for each of the verbal risk descriptors being tested.ResultsA total of 1003 participants were included in the final sample. The risks conveyed by the EC recommended verbal risk descriptors were greatly overestimated by participants. Two distinct distributions were apparent for participant estimates of side effect risks: those for 'high risk' verbal descriptors (e.g. 'common', 'likely', 'high chance') and those for 'low risk' verbal descriptors (e.g. 'uncommon', 'unlikely', 'low chance'). Within these two groups, the distributions were near to identical regardless of what adverb (e.g. very, high, fair) or adjective (e.g. common, likely, chance) was used. The EC recommended verbal risk descriptors were more likely to be understood in accordance with their intended meanings when describing severe side effects. Very few demographic or psychological factors were consistently associated with how well participants understood the EC recommended verbal risk descriptors.DiscussionThe current verbal risk descriptors used in PILs are ineffective at best and misleading at worst. Discontinuing the use of verbal risk descriptors would limit the likelihood of people overestimating the risk of side effects.

Project description:BACKGROUND:Recently a large clinical trial showed that the use of 13-valent pneumococcal conjugate vaccine (PCV13) among immunocompetent individuals aged 65 years and over was safe and efficacious. The aim of this study was to assess the cost-effectiveness of vaccinating immunocompetent 65 year olds with PCV13 vaccine in England. England is a country with universal childhood pneumococcal conjugate vaccination programme in place (7-valent (PCV7) since 2006 and PCV13 since 2010), as well as a 23-valent pneumococcal polysaccharide (PPV23) vaccination programme targeting clinical risk-groups and those ?65 years. METHOD:A static cohort cost-effectiveness model was developed to follow a cohort of 65 year olds until death, which will be vaccinated in the autumn of 2016 with PCV13. Sensitivity analysis was performed to test the robustness of the results. RESULTS:The childhood vaccination programme with PCV7 has induced herd protection among older unvaccinated age groups, with a resultant low residual disease burden caused by PCV7 vaccine types. We show similar herd protection effects for the 6 additional serotypes included in PCV13, and project a new low post-introduction equilibrium of vaccine-type disease in 2018/19. Applying these incidence projections for both invasive disease and community-acquired pneumonia (CAP), and using recent measures of vaccine efficacy against these endpoints for ?65 year olds, we estimate that vaccination of a cohort of immunocompetent 65 year olds with PCV13 would directly prevent 26 cases of IPD, 69 cases of CAP and 15 deaths. The associated cost-effectiveness ratio is £257,771 per QALY gained (using list price of £49.10 per dose and £7.51 administration costs) and is therefore considered not cost-effective. To obtain a cost-effective programme the price per dose would need to be negative. The results were sensitive to disease incidence, waning vaccine protection and case fatality rate; despite this, the overall conclusion was robust. CONCLUSIONS:Vaccinating immunocompetent individuals aged ?65 years with PCV13 is efficacious. However the absolute incidence of vaccine-type disease will likely become very low due to wider benefits of the childhood PCV13 vaccination programme, such that a specific PCV13 vaccination programme targeting the immunocompetent elderly would not be cost-effective.

Project description:IntroductionSince the advent of e-cigarettes, e-cigarette advertising has escalated and companies are able to use marketing strategies that are not permissible for tobacco products. Research into the effect of e-cigarette advertising on attitudes towards tobacco and e-cigarettes is in its infancy. To date, no research has compared indirect (implicit) measures of attitude towards e-cigarettes with direct (explicit) measures. Furthermore, little consideration has been given to how viewing online advertisements may have an effect on attitudes towards e-cigarettes or how positive attitudes to e-cigarettes may undermine antismoking public health messages. The objectives of this study are to investigate (1) the relationship between explicit and implicit attitudes towards tobacco and e-cigarettes, (2) the effect of e-cigarette advertising on these attitudes and (3) the effect of these attitudes on the efficacy of antismoking health messages.Methods and analysisIn experiment 1 an analysis of covariance will be conducted to determine whether viewing an e-cigarette advertisement, compared with a neutral image, has an effect on implicit or explicit attitudes towards tobacco and e-cigarettes, and if these attitudes differ between smokers, vapers and non-smokers aged 18 - 25 years. In experiment 2, moderation analysis will be conducted to assess whether attitudes towards e-cigarettes moderate the psychological efficacy of antismoking health messages in participants aged 18-65 years. In each experiment, attitudes will be measured preintervention and postintervention and 1 week later (n=150) in participants who are smokers (n=50), vapers (n=50) or non-smokers (n=50).Ethics and disseminationApproval for this study has been given by the London South Bank University's (LSBU) Research Ethics Committee. The findings of these studies will be submitted for publication and disseminated via conferences. The results will be integrated into course provision for practitioners training at LSBU.

Project description:BackgroundFear of side-effects can result in non-adherence to medical interventions, such as medication and chemotherapy. Side-effect expectations have been identified as strong predictors of later perception of side-effects. However, research investigating predictors of side-effect expectations is disparate.ObjectiveTo identify factors associated with side-effect expectations.Search strategyWe systematically searched Embase, Ovid MEDLINE, Global Health, PsycARTICLES, PsycINFO, Web of Science and Scopus.Inclusion criteriaStudies were included if they investigated associations between any predictive factor and expectations of side-effects from any medical intervention.Data extraction and synthesisWe extracted information about participant characteristics, medication, rates of side-effects expected and predictors of side-effect expectations. Data were narratively synthesized.Main resultsWe identified sixty-four citations, reporting on seventy-two studies. Predictors fell into five categories: personal characteristics, clinical characteristics, psychological traits and state, presentation format of information, and information sources used. Using verbal risk descriptors (eg 'common') compared to numerical descriptors (eg percentages), having lower quality of life or well-being, and currently experiencing symptoms were associated with increased side-effect expectations.Discussion and conclusionsDecreasing unrealistic side-effect expectations may lead to decreased experience of side-effects and increased adherence to medical interventions. Widespread communications about medical interventions should describe the incidence of side-effects numerically. Evidence suggests that clinicians should take particular care with patients with lower quality of life, who are currently experiencing symptoms and who have previously experienced symptoms from treatment. Further research should investigate different clinical populations and aim to quantify the impact of the media and social media on side-effect expectations.

Project description:BackgroundNocebo effects ('negative placebo' effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). Misattributing nocebo effects to the medicinal intervention can lead to participants experiencing harmful nocebo effects and may result in distortion of adverse effect reporting. However, little is known about how information on potential side effects is provided to trial participants. There is increasing concern that the way in which potential side effects in clinical trials are described to patients in participant information leaflets (PIL) can in itself cause harm by either increased anxiety, poor adherence or inducing the side effect itself. In this study, we aimed to explore these concerns and identify the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants.MethodsTrials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry (a primary registry of the WHO International Clinical Trials Registry Platform (ICTRP)). Eligible studies were placebo-controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11.ResultsMost of the patient information leaflets were ranked as 'fairly difficult to read' or 'difficult to read' according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33, 64%).DiscussionParticipant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. By comparison, potential benefits from the intervention and/or study were described less often, by shorter text, and only after information about harms.

Dataset Information

How does the side-effect information in patient information leaflets influence peoples' side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England.

Objectives

Design

Setting

Participants

Main outcome measures

Results

Discussion

Publications

How does the side-effect information in patient information leaflets influence peoples' side-effect expectations? A cross-sectional national survey of 18- to 65-year-olds in England.

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