Dataset Information

Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

ABSTRACT:

Background

Current German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The present study investigated whether (1) these misinterpretations also prevail among laypeople and (2) alternative PLs reduce these misinterpretations.

Methods

In March 2017, 397 out of 400 laypeople approached completed an online survey. They were randomized to one of four PL formats: three alternative PLs (drug facts box with/without reading instruction, narrative format with numbers) and one standard PL. Each PL listed four side effects for a fictitious drug: two were presented as occurring more often, one as equally often, and one as less often with drug intake. The alternative formats (interventions) included information on frequencies with and without drug intake and included a statement on the causal relation. The standard PL (control) only included information on frequency ranges with drug intake. Questions were asked on general occurrence and causality of side effects.

Results

Participants randomized to the standard PL were unable to answer questions on causality. For side effects occurring more often (equally; less often) with drug intake, only 1.9% to 2.8% (equally: 1.9%; less often: 1.9%) provided correct responses about the causal nature of side effects, compared to 55.0% to 81.9% (equally: 23.8% to 70.5%; less often: 21.0% to 43.2%) of participants who received alternative PLs. It remains unclear whether one alternative format is superior to the others.

Conclusion

In conclusion, information on the frequency of side effects in current package leaflets is misleading. Comparative presentation of frequencies for side effects with and without drug intake including statements on the causal relation significantly improves understanding.

SUBMITTER: Muhlbauer V

PROVIDER: S-EPMC6136776 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

Mühlbauer Viktoria V Prinz Roman R Mühlhauser Ingrid I Wegwarth Odette O

PloS one 20180913 9

<h4>Background</h4>Current German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The present study investigated whether (1) these misinterpretations also prevail among laypeople and (2) alternative PLs reduce these misinterpretati ...[more]

PMID: 30212555

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Project description:BACKGROUND:Promiscuity in molecular interactions between small-molecules, including drugs, and proteins is widespread. Such unintended interactions can be exploited to suggest drug repurposing possibilities as well as to identify potential molecular mechanisms responsible for observed side-effects. METHODS:We perform a large-scale analysis to detect binding-site molecular interaction field similarities between the binding-sites of the primary target of 400 drugs against a dataset of 14082 cavities within 7895 different proteins representing a non-redundant dataset of all proteins with known structure. Statistically-significant cases with high levels of similarities represent potential cases where the drugs that bind the original target may in principle bind the suggested off-target. Such cases are further analysed with docking simulations to verify if indeed the drug could, in principle, bind the off-target. Diverse sources of data are integrated to associated potential cross-reactivity targets with side-effects. RESULTS:We observe that promiscuous binding-sites tend to display higher levels of hydrophobic and aromatic similarities. Focusing on the most statistically significant similarities (Z-score???3.0) and corroborating docking results (RMSD?<?2.0 Å), we find 2923 cases involving 140 unique drugs and 1216 unique potential cross-reactivity protein targets. We highlight a few cases with a potential for drug repurposing (acetazolamide as a chorismate pyruvate lyase inhibitor, raloxifene as a bacterial quorum sensing inhibitor) as well as to explain the side-effects of zanamivir and captopril. A web-interface permits to explore the detected similarities for each of the 400 binding-sites of the primary drug targets and visualise them for the most statistically significant cases. CONCLUSIONS:The detection of molecular interaction field similarities provide the opportunity to suggest drug repurposing opportunities as well as to identify potential molecular mechanisms responsible for side-effects. All methods utilized are freely available and can be readily applied to new query binding-sites. All data is freely available and represents an invaluable source to identify further candidates for repurposing and suggest potential mechanisms responsible for side-effects.

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Project description:BACKGROUND:The Dutch Ministry of Health has formulated ambitious goals concerning the use of telehealth, leading to subsequent changes compared with the current health care situation, in which 93% of care is delivered face-to-face. Since most care is delivered to older people, the prospect of telehealth raises the question of whether this population is ready for this new way of receiving care. To study this, we created a theoretical framework consisting of 6 factors associated with older people's intention to use technology. OBJECTIVE:The objective of this study was to understand community-dwelling older people's readiness for receiving telehealth by studying their intention to use videoconferencing and capacities for using digital technology in daily life as indicators. METHODS:A mixed-method triangulation design was used. First, a cross-sectional survey study was performed to investigate older people's intention to use videoconferencing, by testing our theoretical framework with a multilevel path analysis (phase 1). Second, for deeper understanding of older people's actual use of digital technology, qualitative observations of older people executing technological tasks (eg, on a computer, cell phone) were conducted at their homes (phase 2). RESULTS:In phase 1, a total of 256 people aged 65 years or older participated in the survey study (50.0% male; median age, 70 years; Q1-Q3: 67-76). Using a significance level of .05, we found seven significant associations regarding older people's perception of videoconferencing. Older people's (1) intention to use videoconferencing was predicted by their performance expectancy (odds ratio [OR] 1.26, 95% CI 1.13-1.39), effort expectancy (OR 1.23, 95% CI 1.07-1.39), and perceived privacy and security (OR 1.30, 95% CI 1.17-1.43); (2) their performance expectancy was predicted by their effort expectancy (OR 1.38, 95% CI 1.24-1.52); and (3) their effort expectancy was predicted by their self-efficacy (OR 1.55, 95% CI 1.42-1.68). In phase 2, a total of 6 men and 9 women aged between 65 and 87 years participated in the qualitative observation study. Of the primary themes, 5 themes were identified that could provide greater understanding of older people's capacities and incapacities in using digital technology: (1) "self-efficacy and digital literacy," (2) "obstacles to using technology," (3) "prior experience and frequency of use," (4) "sources of support and facilitating conditions," and (5) "performance expectancy." These 5 themes recurred in all 15 observations. CONCLUSIONS:Performance expectancy, effort expectancy, and perceived privacy and security are direct predictors of older people's intention to use videoconferencing. Self-efficacy appeared to play a role in both older people's intention to use, as well as their actual use of technology. The path analysis revealed that self-efficacy was significantly associated with older people's effort expectancy. Furthermore, self-efficacy and digital literacy appeared to play a major role in older people's capacities to make use of digital technology.

Project description:BackgroundRandomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People's Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial.MethodsUsing a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial.ResultsOver 3000 members of the public, from 72 countries, participated in The People's Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. 'Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?' We report the processes of The People's Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned.ConclusionThe People's Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims.Trial registrationClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.

Dataset Information

Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

Background

Methods

Results

Conclusion

Publications

Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

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