Balance appointment information leaflets: Employing performance-based user-testing to improve understanding

Brooke, Ruth E.; Herbert, Nicholas; Isherwood, Sarah; Knapp, Peter; Raynor, David K.

doi:10.3109/14992027.2012.745200

Cited by 11 publications

(6 citation statements)

References 29 publications

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“…In addition, there is a combined need to evaluate whether the structure and the content of the leaflet meets the understanding level of participants. In addition, it may be worthwhile verifying the availability and readability of the information leaflet directly among consumers by using performance-based user testing [50–52].…”

Section: Discussionmentioning

confidence: 99%

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Choi

Lee

2019

PLoS ONE

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Objectives This study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea. Methods Through purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis. Results Themes raised throughout the interviews were categorised into ‘disclosure’ and ‘understanding’ of clinical information and ‘decision’. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants’ level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent. Conclusion There is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.

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Section: Discussionmentioning

confidence: 99%

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Choi

Lee

2019

PLoS ONE

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“…In contrast to individual interviews used by most “user testings” [ 19 – 24 , 30 ], the discursive focus group setting also allowed for controversial discussion amongst the participants, which helped reveal contrasting opinions and misunderstandings, e.g. a discussion in one focus group revealed that some test-readers presumed that all donated specimens were analysed by the biobank and, hence, they believed that participants could hope for diagnostic benefits.…”

Section: Discussionmentioning

confidence: 99%

Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections

et al. 2017

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BackgroundFor valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers’ understanding and reactions.MethodsWe tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with members from the documents’ target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process.ResultsFocus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic.ConclusionOur results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers’ understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future.Electronic supplementary materialThe online version of this article (10.1186/s12910-017-0232-7) contains supplementary material, which is available to authorized users.

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“…PILs are perceived as useful, but they can also generate adverse emotional reactions ( Herber et al, 2014 ; Afreh et al, 2017 ; Thomas et al, 2018 ). In addition, the PILs in the current market are considerably illegible ( Rajasundaram et al, 2006 ; Symonds et al, 2011 ; Brooke et al, 2013 ; Spinillo, 2014 ; Bennin and Rother, 2015 ; Clausen et al, 2016 ; Alaqeel and al Obaidi, 2017 ; Haller et al, 2019 ; Zidarič and Kreft, 2019 ), impractical to use ( Sukkari et al, 2012 ), and can generate emotional discomfort and confusion due to their format. Therefore, several factors that facilitate the PIL understanding need to be consolidated in a future proposal to improve the PILs.…”

Section: Discussionmentioning

confidence: 99%

“…The leaflets must be clear and concise in their explanations and must be available in the user's language and adapted to their understanding (Clausen et al, 2016;Khodambashi et al, 2017). However, a considerable proportion of the leaflets evaluated in these articles did not meet these characteristics as they were not understood by the general public (Rajasundaram et al, 2006;Symonds et al, 2011;Brooke et al, 2013;Spinillo, 2014;Bennin and Rother, 2015;Alaqeel and al Obaidi, 2017;Haller et al, 2019), nor did they meet the parameters of utility (Sukkari et al, 2012), readability (Kasesnik and Kline, 2011), adaptation to the educational level of the target population (Cronin et al, 2011), or use of non-medical terminology (Hirsh et al, 2009;Bennin and Rother, 2015). Participants in other studies confirmed that the leaflets were clear, legible (Gustafsson et al, 2005;Williamson and Martin, 2010;Potter et al, 2014), and useful (Edwards et al, 2013), even though the participants showed low scores in a test on knowledge acquired from the PILs (Alaqeel and al Obaidi, 2017).…”

Section: Leaflet Variablesmentioning

confidence: 99%

Factors that Facilitate and Hinder the Comprehension of Patient Information Leaflets (PILs): A Brief Scoping Review

et al. 2021

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Introduction: Patient information leaflets (PILs) of medicinal products are informative documents that accompany medicines and explain their components, modes of use, interactions with other medicines, and other relevant issues. When patients do not adequately understand the information in the leaflets, they may engage in behaviors that affect their health (e.g., self-medication).Objective: To identify patient-related factors and characteristics of PILs that can promote cognitive, emotional, and behavioral changes that lead to appropriate drug use practices. Additionally, we aimed to determine strategies that could be implemented to design leaflets that convey adequate information and are easier to understand.Method and Results: We evaluated scientific articles published in databases and containing information on PILs suitability to be used in a patient population. A total of 51 articles were selected as the sample. Certain leaflet factors that favored or hindered understanding were identified (e.g., format in which the leaflets are presented, their structure, their adaptation to the sociodemographic and linguistic characteristics of the population, their wording…). Similarly, we also identified patient factors, such as previous experience taking the drugs referred to in the leaflet; the type of emotions experienced when reading the leaflets; the emphasis on the adverse effects of the medications; sociodemographic variables (i.e., age or educational level); and degree of interest in their own healthcare.Conclusion: Patient and leaflet factors influence the comprehension of information in the PIL; hence, emphasis should be placed on these factors to increase treatment and medication adherence and to reduce health-risk behaviors.

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Balance appointment information leaflets: Employing performance-based user-testing to improve understanding

Cited by 11 publications

References 29 publications

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections

Factors that Facilitate and Hinder the Comprehension of Patient Information Leaflets (PILs): A Brief Scoping Review

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