Improving knowledge and trust in vaccines: A survey-based assessment of the potential of the European Union Clinical Trial Regulation No 536/2014 plain language summary to increase health literacy |
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Affiliation: | 1. GSK, Avenue Fleming 20, B-1300 Wavre, Belgium;2. InSites Consulting, 51 Lever Street, Manchester M1 1FN, UK |
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Abstract: | The European Clinical Trial Regulation No 536/2014 is the first mandate for a non-technical, publicly disclosed, plain language summary (PLS) of clinical trial results. This easy-to-understand summary has the potential to inform the public about clinical trial results and thereby improve health literacy in vaccines.To investigate the utility of the PLS, we undertook 2 online surveys (July/October 2020) in the United Kingdom, the United States and India. Participants were selected by quota sampling to ensure representation of gender, age and parental status. Those lacking interest in vaccine clinical research were excluded. In survey 1, participants were questioned about their interest in and expectations of vaccine trial results. In survey 2, the perceptions of participants to a range of written communication styles used in publicly available PLSs were evaluated.A total of 66 (13%) and 122 (29%) individuals were excluded solely due to lack of interest in vaccine clinical research in surveys 1 and 2, respectively; 450 respondents (150/country) completed survey 1 and 300 (100/country) completed survey 2. In survey 1, there was a correlation (p < 0.01) between claimed knowledge of and trust in vaccines. Healthcare professionals were the most trusted source for vaccine information, while vaccine companies were ranked relatively low. In survey 2, infographic PLS formats were considered easiest to understand, most engaging and the strongest communicators. Emphasizing the main points of the infographics in the text did not improve comprehension or recall. Most respondents (86%) indicated that they would like to see this type of communication in the future.Overall, this research suggests that the PLS, by optimizing content and format, has a potential to increase health literacy, and thereby, as part of a wider integrated communication strategy, build vaccine knowledge and confidence. |
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Keywords: | Plain language summary (PLS) Public engagement Vaccine confidence Transparency Clinical trial results disclosure Vaccines COVID-19" },{" #name" :" keyword" ," $" :{" id" :" k0040" }," $$" :[{" #name" :" text" ," _" :" coronavirus disease 2019 CTD" },{" #name" :" keyword" ," $" :{" id" :" k0050" }," $$" :[{" #name" :" text" ," _" :" Clinical Trial Directive CTR" },{" #name" :" keyword" ," $" :{" id" :" k0060" }," $$" :[{" #name" :" text" ," _" :" Clinical Trial Regulation dTpa" },{" #name" :" keyword" ," $" :{" id" :" k0070" }," $$" :[{" #name" :" text" ," _" :" tetanus-reduced-antigen-content-diphtheria-acellular pertussis vaccine DTPa-HBV-IPV/Hib" },{" #name" :" keyword" ," $" :{" id" :" k0080" }," $$" :[{" #name" :" text" ," $$" :[{" #name" :" __text__" ," _" :" hexavalent vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and " },{" #name" :" italic" ," _" :" Haemophilus influenzae" },{" #name" :" __text__" ," _" :" type-b EU" },{" #name" :" keyword" ," $" :{" id" :" k0090" }," $$" :[{" #name" :" text" ," _" :" European Union FDA" },{" #name" :" keyword" ," $" :{" id" :" k0100" }," $$" :[{" #name" :" text" ," _" :" Food and Drug Administration HCP" },{" #name" :" keyword" ," $" :{" id" :" k0110" }," $$" :[{" #name" :" text" ," _" :" healthcare professional PLS" },{" #name" :" keyword" ," $" :{" id" :" k0120" }," $$" :[{" #name" :" text" ," _" :" plain language summary UK" },{" #name" :" keyword" ," $" :{" id" :" k0130" }," $$" :[{" #name" :" text" ," _" :" United Kingdom US" },{" #name" :" keyword" ," $" :{" id" :" k0140" }," $$" :[{" #name" :" text" ," _" :" United States |
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