From research to evidence-informed decision making: a systematic approach.

Background: Knowledge creation forms an integral part of the knowledge-to-action framework aimed at bridging the gap between research and evidence-informed decision making. Although principles of science communication, data visualisation and user-centred design largely impact the effectiveness of communication, their role in knowledge creation is still limited. Hence, this article aims to provide researchers a systematic approach on how knowledge creation can be put into practice. Methods: A systematic two-phased approach towards knowledge creation was formulated and executed. First, during a preparation phase the purpose and audience of the knowledge were defined. Subsequently, a developmental phase facilitated how the content is 'said' (language) and communicated (channel). This developmental phase proceeded via two pathways: a translational cycle and design cycle, during which core translational and design components were incorporated. The entire approach was demonstrated by a case study. Results: The case study demonstrated how the phases in this systematic approach can be operationalised. It furthermore illustrated how created knowledge can be delivered. Conclusion: The proposed approach offers researchers a systematic, practical and easy-to-implement tool to facilitate effective knowledge creation towards decision-makers in healthcare. Through the integration of core components of knowledge creation evidence-informed decision making will ultimately be optimized.

Medical decision-making in children and adolescents: developmental and neuroscientific aspects.

BACKGROUND: Various international laws and guidelines stress the importance of respecting the developing autonomy of children and involving minors in decision-making regarding treatment and research participation. However, no universal agreement exists as to at what age minors should be deemed decision-making competent. Minors of the same age may show different levels of maturity. In addition, patients deemed rational conversation-partners as a child can suddenly become noncompliant as an adolescent. Age, context and development all play a role in decision-making competence. In this article we adopt a perspective on competence that specifically focuses on the impact of brain development on the child's decision-making process. MAIN BODY: We believe that the discussion on decision-making competence of minors can greatly benefit from a multidisciplinary approach. We adopted such an approach in order to contribute to the understanding on how to deal with children in decision-making situations. Evidence emerging from neuroscience research concerning the developing brain structures in minors is combined with insights from various other fields, such as psychology, decision-making science and ethics. Four capacities have been described that are required for (medical) decision-making: (1) communicating a choice; (2) understanding; (3) reasoning; and (4) appreciation. Each capacity is related to a number of specific skills and abilities that need to be sufficiently developed to support the capacity. Based on this approach it can be concluded that at the age of 12 children can have the capacity to be decision-making competent. However, this age coincides with the onset of adolescence. Early development of the brain's reward system combined with late development of the control system diminishes decision-making competence in adolescents in specific contexts. We conclude that even adolescents possessing capacities required for decision-making, may need support of facilitating environmental factors. CONCLUSION: This paper intends to offer insight in neuroscientific mechanisms underlying the medical decision-making capacities in minors and to stimulate practices for optimal involvement of minors. Developing minors become increasingly capable of decision-making, but the neurobiological development in adolescence affects competence in specific contexts. Adequate support should be offered in order to create a context in which minors can make competently make decisions.

Research information for minors: Suitable formats and readability. A systematic review.

As children age, their capacity to consent or dissent to research participation increases. Numerous regulations and guidelines require that children should receive information 'according to their capacity of understanding'. In order to gain more insight in the quality of patient information forms for minors, a systematic literature search was performed. Two aspects of quality will be analysed in this paper: the effect of format on understanding and the readability of text in the documents. A systematic search was executed in PubMed, Embase and PsycINFO. Seventeen papers on format were included. Interventions testing information formats indicate that improvement is possible, but outcome measurement varied per study and no apparently successful intervention was repeated. Only three readability papers were found, all indicating a readability gap between patient information forms and children's actual reading level. The results indicate an urgent need for further research on how to adequately inform minors about clinical trials.

The extent and effects of patient involvement in pictogram design for written drug information: a short systematic review.

This short review provides insight into the extent and effectiveness of patient involvement in the design and evaluation of pictograms to support patient drug information. Pubmed, CINAHL, Cochrane Library, Embase, PsycINFO, Academic Search Premier and Web of Science were searched systematically; the 73 included articles were evaluated with the MMAT. We see that, usually, non-patient end-users are involved in the design of pharmaceutical pictograms - patients are more commonly involved in the final evaluation of pictogram success. Repeated involvement of (non-)patients aids the design of effective pharmaceutical pictograms, although there is limited evidence for such effects on patient perception of drug information or health behaviour.

Pharmaceutical pictograms for low-literate patients: Understanding, risk of false confidence, and evidence-based design strategies.

OBJECTIVE: This study aims to (1) evaluate ten pharmaceutical pictograms for low-literate patients on understandability, (2) assess the risk of false confidence in understanding, and (3) identify how the design can be improved to increase understandability. METHODS: Interviews were conducted with n=197 pharmacy visitors in the Netherlands. Additional qualitative discussions were held with n=30 adequately and n=25 low-literate participants (assessed with REALM-D). Qualitative data were analysed using the Thematic Framework approach. RESULTS: Half of the pictograms reached 67% understanding (31.0%-98.5%); two did in the low-literate group. Three pictograms showed a risk for false confidence. Pictograms appeared to be most effective when people were familiar with their visual elements and messages. CONCLUSION: Low-literate people have more difficulty understanding pictograms than people with adequate literacy. While the risk of false confidence is low, for critical safety information, 67% understanding might not be sufficient. Design strategies for pharmaceutical pictograms should focus on familiarity, simplicity, and showing the intake and effect of medicine. PRACTICE IMPLICATIONS: Health professionals should go over the meaning of pictograms when providing drug information to patients to increase patients' familiarity with the message and to ensure that all pictograms are sufficiently understood.

Perspectives of adolescents on decision making about participation in a biobank study: a pilot study.

OBJECTIVES: To be able to truly involve adolescents in decision making about clinical research participation, we need more insight in the perspective of adolescents themselves. To this end, adolescents in an ongoing biobank study were consulted to test a tentative decision assessment tool. METHODS: The perspectives of adolescents (n=8) concerning participation in decision making for research participation were explored in interviews with a tentative tool, which covered six topics: information material usage, understanding, disease perceptions, anxiety, decision-making process and role sharing. RESULTS: All adolescents unequivocally expressed the desire to be involved in decision making, but also wanted advice from their parents. The extent of the preferred role of adolescent versus parents varied between individuals. In decision making, adolescents relied on parents for information. More than half hardly used the information material. CONCLUSIONS: Adolescents in our study preferred a shared decision-making process. The extent of sharing varied between individuals. The decision assessment tool was a fruitful starting point to discuss adolescents' perspectives and may aid in tailoring the situation to the individual to achieve optimal participation practices. IMPLICATIONS: Consulting adolescents about their preferences concerning decision making using the tool will facilitate tailoring of the shared decision-making process and optimising the developing autonomy of minors.

Citizen science on a smartphone: Participants' motivations and learning.

Citizen science provides researchers means to gather or analyse large datasets. At the same time, citizen science projects offer an opportunity for non-scientists to be part of and learn from the scientific process. In the Dutch iSPEX project, a large number of citizens turned their smartphones into actual measurement devices to measure aerosols. This study examined participants' motivation and perceived learning impacts of this unique project. Most respondents joined iSPEX because they wanted to contribute to the scientific goals of the project or because they were interested in the project topics (health and environmental impact of aerosols). In terms of learning impact, respondents reported a gain in knowledge about citizen science and the topics of the project. However, many respondents had an incomplete understanding of the science behind the project, possibly caused by the complexity of the measurements.

Low literacy and written drug information: information-seeking, leaflet evaluation and preferences, and roles for images.

Background Low-literate patients are at risk to misinterpret written drug information. For the (co-) design of targeted patient information, it is key to involve this group in determining their communication barriers and information needs. Objective To gain insight into how people with low literacy use and evaluate written drug information, and to identify ways in which they feel the patient leaflet can be improved, and in particular how images could be used. Setting Food banks and an education institution for Dutch language training in the Netherlands. Method Semi-structured focus groups and individual interviews were held with low-literate participants (n = 45). The thematic framework approach was used for analysis to identify themes in the data. Main outcome measure Low-literate people's experience with patient information leaflets, ideas for improvements, and perceptions on possible uses for visuals. Results Patient information leaflets were considered discouraging to use, and information difficult to find and understand. Many rely on alternative information sources. The leaflet should be shorter, and improved in terms of organisation, legibility and readability. Participants thought images could increase the leaflet's appeal, help ask questions, provide an overview, help understand textual information, aid recall, reassure, and even lead to increased confidence, empowerment and feeling of safety. Conclusion Already at the stages of paying attention to the leaflet and maintaining interest in the message, low-literate patients experience barriers in the communication process through written drug information. Short, structured, visual/textual explanations can lower the motivational threshold to use the leaflet, improve understanding, and empower the low-literate target group.

Comic strips help children understand medical research: targeting the informed consent procedure to children's needs.

OBJECTIVE: Children involved in medical research often fail to comprehend essential research aspects. In order to improve information provision, a participatory approach was used to develop new information material explaining essential concepts of medical research. METHODS: A draft of a comic strip was developed by a science communicator in collaboration with pediatricians. The draft was presented to children participating in a clinical trial and to two school classes. Children were consulted for further development in surveys and interviews. Subsequently, the material was revised and re-evaluated in four school classes with children of varying ages and educational levels. RESULTS: In the first evaluation, children provided feedback on the storyline, wording and layout. Children thought the comic strip was 'fun' and 'informative'. Understanding of 8 basic research aspects was on average 83% and all above 65%, illustrating that children understood and remembered key messages. CONCLUSION: A comic strip was developed to support the informed consent process. Children were consulted and provided feedback. The resulting material was well understood and accepted. PRACTICE IMPLICATIONS: Involving children in the development of information material can substantially contribute to the quality of the material. Children were excited to participate and to 'be a part of science'.