Information Design for Diagnostics: Ensuring Confidence and Accuracy for Home Sampling and Home Testing

Lead Research Organisation: University of Reading
Department Name: Typography and Graphic Communication

Abstract

n this inter-disciplinary project, information designers are working with diagnostic technology researchers on the design of procedural instructions and information to accompany home testing and home sampling kits.

COVID-19 testing has placed an unprecedented burden on diagnostics services and sample collection remains a major bottleneck. Samples taken at home can be sent to labs, avoiding the need for sample collection at a clinic or hospital. Point-of-care testing technology can also allow testing in the home, without requiring a diagnostic lab. In both home sampling and home testing, simplicity and accuracy is critical to compliance.

We will design spoken and written instructions for home sampling - where fingerstick blood is sent to central labs for testing; and for home testing using conventional lateral flow rapid tests. Information design methods, including evaluation of effectivenesss with a cohort of volunteers will ensure that the needs of users are met. We will combine established information design principles with novel methodology exploiting videolink research plus 3D printed models of home testing equipment to develop a complete set of guidance for a wide range of home diagnostics.

By contributing to the success and viability of mass home testing, our work will have economic, social and health impact and unburden health centres with people that need to physically attend for testing.
 
Description The outcome of this project are recommendations for the design of procedural instructions for diagnostic tests carried out by lay people. These Point of Use instructions need to e user friendly and we have used information design research and practice, and feedback from a user panel and project partners to produce a set of transferable principles that can be applied to different kinds of home-testing kits. The recommendations are presented in the form of a Toolkit - that explains how Point of Use instructions can be made to take account of the needs of end users.

Overall our research indicated that:
- the application of information design research and practice enhances user access to instructional text
- consistency in presentation of language and images is helpful to users
- an overview of procedural steps carrying out a test helps users
- it is beneficial to involve end users by asking what they think about draft versions of sets of instructions before finalising
- instructions are accessible to more audiences when both print and digital formats are available; video versions provide an accessible overview of the procedure, and print versions allows people to go at their own pace, and to review their progress
- particular care is needed for describing and illustrating action steps that may be are perceived as challenging due to the dexterity needed
- while regulations strive to ensure in-vitro diagnostic test products are usable, in some cases there is a discrepancy between mandatory requirements, and clear and simple instructions and guidance for use
Exploitation Route We have secured additional funding from University of Reading's Rapid Response Policy Engagement initiative for a project 'Testing, testing; translating research into accessible information for acting on policy'. This involves making diagnostic testing manufacturers and service providers aware of the benefit of providing accessible Point of Use instructions to supplement their products / engagement with the public. We have a produced a 'toolkit' and a dataset for the design of instructions to support home and community diagnostic testing. 'User-friendly point-of-use instructions for home use diagnostic tests' provides evidence-based guidance and tools for manufacturers of tests, service providers and content and design specialists who produce instructions to accompany diagnostic tests for home and community use. The toolkit, organised in 5 sections provides guidance on writing, visual organisation and how to engage with your users.

We received some of the University of Reading's AHRC Impact Accelerator Account to further extend this project. We aimed to investigate how the toolkit guidance can be applied beyond instructions for COVID-19 lateral-flow tests (the focus of the initial research). We aimed to extend this work to a wider set of people who may benefit from this work, and who can work with us to identify how, within their areas, the application of the toolkit guidance will benefit the people they work with. We achieved the following:
1 Opportunity to engage with JR Medical Ltd working with the NHS on the development of a range of tests to be used at home by lay people, with the tests provided to the patient by their doctor. John Rees, Managing Director, has asked for advice about providing Point of Use instructions for the tests (ideally to complement the regulatory instructions for use that are not produced for end users). This case study would ideally have started late last year had funding been agreed then, so part of this work may mean working on instructions for another range of tests that JR Medical is developing
2 Following up other similar enquiries eg with Cancer Care / Roche Diagnostics
3 We have been approached by the University of Oxford to contribute to an NIHR bid in the new year which will be on self-testing at home for COPD patients.
Yes - this work is following on from IAA funded work to further extend the impact of an evidence-based, practical toolkit for writing and designing instructions for diagnostic home-testing kits. 'User-friendly point-of-use instructions for home use diagnostic tests: guidance and tools'. To date we have engaged with 48 experts and stakeholders, of which, 24 participated via video call or email (Fig 1).

A range of self and point-of-care (POC) tests were suggested by the healthcare practitioners, professionals, academics and pharmaceutical industry and medical device manufacturers, for consideration for case study analysis, which are as follows:

Cheshire & Merseyside Cancer Alliance: Faecal Immunochemical test (FIT);Cervical cancer test (home sample/lab diagnostic)
RM Partners Cancer Alliance (North & Southwest London): FITCervical cancer test (home sample/lab diagnostic) Ongoing discussion
Roche Diabetes International Normalised Ratio (INR) self-test Capillary POC test for human papillomavirus (HPV)
University of Reading, University of Southampton: Urine antibiotic susceptibility laboratory test Laboratory-based test
Yorkshire & Humber Partners Academic Health Science Network (AHSN): Troponin self-test, Preeclampsia self-test, Kidney function self-test, Urinatory tract infection self-test, Asthma inhaler community project
Sectors Healthcare

Pharmaceuticals and Medical Biotechnology

URL https://research.reading.ac.uk/design-research-for-testing-diagnostics/
 
Description It is early to say, but we have some evidence, particularly from clinicians working in GP practices, that easy to follow instructions (based on the findings of the research) are welcomed. The project has also resulted in collaboration with industry: Roche Diagnostics asked us to apply our findings to instructions for the Standard Operating Procedure for use of lateral flow test kits for viral flu, to be used in GP surgeries. We undertook a series of studies for the Department of Health and Social Care, who wanted feedback on the usability of saliva-based lateral flow kits.
First Year Of Impact 2021
Sector Healthcare,Pharmaceuticals and Medical Biotechnology
Impact Types Policy & public services

 
Title User-friendly point-of-use instructions for home use diagnostic tests 
Description This toolkit provides guidance for producing clear and user-friendly point-of-use instructions for testing kits. It is for: - manufacturers and distributors of tests - service providers who might want to brief designers and content specialists - content specialists and designers who need information about producing instructional text This guidance includes: - information about what you should consider when producing user-friendly instructions, based on the findings of research and good practice - examples of how the guidance has been applied by those who implement policy in diagnostic companies The toolkit has been designed primarily to support instructions in a static/fixed page layout. 
Type Of Material Database/Collection of data 
Year Produced 2022 
Provided To Others? Yes  
Impact This toolkit is now being tested with potential users through a project funded by AHRC Impact Accelerator. This enabled exploration of the usefulness of the toolkit with Roche Diagnostics and diagnostic test manufacturers. 
URL https://researchdata.reading.ac.uk/id/eprint/419
 
Description Collaboration with diagnostic test providers 
Organisation F. Hoffmann-La Roche AG
Department Roche Diagnostics, UK
Country United Kingdom 
Sector Private 
PI Contribution The team introduced user-centred Point of Use instructions to the marketing and out-reach team, and explained the project research to date. The team designed versions of diagrams showing different illustration styles, based on observations from the Roche team, and explained the next stages in the project including asking for advice about research users
Collaborator Contribution The Roche team provided information about their experience of using lateral flow tests in the workplace. They provided contacts to extend the reach of our work. The team provided feedback on the illustrations styles.
Impact The outcomes from the discussions are prototype Point of Use instructions for lateral flow tests. This led to a project that applied the design features from the prototypes to other forms for health-related procedural instructions. The disciplines involved in this work are biological science, information design, nursing and NHS general practice.
Start Year 2021
 
Description Expert commentary and journalist support on Covid-19 pandemic, especially rapid and home testing 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Having conducted research into new technologies for point-of-care and out-of-hospital diagnostic testing for over a decade, I have been able to bring my expertise and knowledge to apply to the important topic of covid-19 testing, that has been prominent in public debate during the pandemic. This has ranged from assessing latest developments or data regarding the quality and performance of rapid tests, to explaining how tests work, to providing insight into strengths and limitations of testing products such as lateral flow rapid tests, that entered our homes -often for the first time -in 2021.
During 2021 our University press office noted >3,000 mentions of "Al Edwards University of Reading" in press or online, giving an idea of the scale and reach of this media activity.
This includes: mainstream media (print and online), regular radio and occasional TV interviews, and fact checkers.
Examples include: "your Covid questions answered" weekly on local BBC radio, through to regular mentions in mainstream media (Daily Mail, Mail online, Guardian, BBC website).
In addition to the general public, I have advised journalists writing for more specialist audiences including New Scientist and British Journal of Medicine.

A major route to this public awareness activity and media engagement is through the Science Media Center, a vital and central institution that has consistently supported connections between scientists and journalists throughout the pandemic.
Year(s) Of Engagement Activity 2021,2022
 
Description Interdisciplinary network event 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The presentation: 'Information Design in medical testing' aimed to raise awareness of the relevance and importance of information design in making instructions for home- and community-use diagnostic test easy to understand. The presentation drew attention to research-informed guidance in the form of a toolkit. Attendees expressed interest in the guidance and could see how they might use it. They were pleased that the information, templates and draft illustrations were available for all to dopwnload and use.
Year(s) Of Engagement Activity 2023
 
Description Talk and panel discussion at information design conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact This talk 'Designing instructions for COVID-19 self-tests: how do people use static and video instructions, and what parts of the test are the most difficult to get right?' was part of the Information+ conference in August 2021. The talk was available online and this was followed by a panel discussion with other participants who had submitted papers onthe theme of health.
Year(s) Of Engagement Activity 2021
URL https://research.reading.ac.uk/design-research-for-testing-diagnostics/information-conference-2021/