Harmonising the human biobanking consent process: an Irish experience

Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

General and Paediatric Dentists’ Knowledge, Attitude and Practices Regarding the use of Silver Diammine Fluoride for the Management of Dental Caries: A National Survey in the Netherlands

Background: Silver Diammine Fluoride (SDF) is a topical medication used to arrest cavitated carious lesions non-invasively. The primary aim of this research was to investigate, and analyse the relationships between; knowledge, attitudes and practices (including barriers and facilitators) as they relate to SDF use for the management of dental caries by general dental practitioners (GDPs) and paediatric dentists (PDs) in the Netherlands. A secondary aim was to explore any differences between these groups.Methods: A sample of 600 Dutch GDPs (random selection from 9,777 registered) and all 57 registered PDs were invited to participate in this cross-sectional survey, consisting of four sections: 1) participant characteristics, 2) knowledge (through responses to summative questions), 3) attitudes (through agreements using 5-point Likert scale), and 4) practices, use, barriers and facilitators (through multiple choice questions). Results: Response rates were: GDPs 23% (n=140) and PDs 47% (n=27). Knowledge: out of 15 questions testing understanding of SDF, the mean correct answers were GDPs 6.7; SD 2.6 and PDs 7.4, SD 2.2 (no statistically significant differences). Mean overall attitude score showed positivity towards SDF use in both groups. Compared to GDPs, PDs were more likely to use SDF (p<0.001) and expected this to increase (p=0.03). The main barrier for users was parental acceptance (47%) and for non-users it was lack of knowledge (60%). The main facilitator for both users and non-users was gaining knowledge through courses and workshops, followed by written information leaflets about SDF for parents.Conclusions: Less than half knowledge questions about SDF were answered correctly. Despite low knowledge, attitude towards its use was positive. Practitioners believed that its use would be facilitated by professionals having more accessible information and training and by the availability of parent information leaflets. SDF was used more frequently by PDs than GDPs.

IMPARTER, Phase 1 of an intervention to improve patients’ understanding of gene expression profiling tests in breast cancer

Purpose To compare participants’ knowledge about gene expression profiling (GEP) tests and recurrence risks after reading an information leaflet with that following viewing of an information film. Methods Using a randomised cross-over design, at time-point one (T1), women aged 45–75 years without breast cancer either read leaflets or watched information films about Oncotype DX or Prosigna tests. Participants answered nine questions assessing knowledge (maximum score 18). Next-day information in the opposite modality was provided and knowledge re-assessed. Additional questions probed which format was easiest to understand, participants’ preferences for film or leaflet and their reasons for these. Results 120 women participated (60 received OncotypeDX films and leaflets; 60 received the Prosigna versions). T1 mean knowledge scores were higher following film viewing (13.37) compared with that after reading leaflets (9.25) (mean difference 4.1; p < 0.0001; 95% CI 3.2, 5.0). When participants read leaflets first and subsequently viewed films, all increased their scores (mean + 6.08, from T1 of 9.25, p < 0.0001; 95% CI 5.44, 6.72). When films were viewed first, followed by leaflets, (36/60, 60%), participants’ scores declined (mean-1.55 from T1 of 13.37, p < 0.001; 95% CI -2.32, -0.78). A majority of participants expressed preferences for the films (88/120, 73.3%) irrespective as to whether they described OncotypeDX or Prosigna. Reasons included the clarity, ease of understanding, visual material and reassuring voice-over. Conclusion Discussions between oncologists and patients about recurrence risk results can be challenging. Information leaflets may aid understanding but often employ complex language. Information films significantly improved knowledge and were preferred by participants.

Better Health Communication During the Life Cycle Contributes to Better Health Literacy

Health literacy (HL) is about acquiring competences, confidence, and motivation to take action in health improvement. Health communication is key in promoting HL. Information leaflets are a tool that grants autonomy, thereby empowering self-management of health. Qualitative and content analysis of two original leaflets was made by a group of medical doctors, targeting pregnant women and the elderly, who represent different stages of the life cycle. The content was written in an assertive, clear, and positive language, and was adjusted to the target public. A question-answer system was used, making it easier for the reader to gather specific information. Structural aspects underlying both leaflets were similar. Health leaflets are widely used for the proper transmission of information. It is therefore essential that they are appropriate to the recipients' HL throughout the life cycle. The critical and systematised analysis of their information content contributes to quality assurance, leading to better HL and healthcare in general.

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

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.