Issues and opportunities at the patient interface with imaging research

Report of the Workshop with Patients and Public on what is important to them in respect to participation in imaging research on 29th November 2019

What is this report about?

This report is about what patients think are important issues and considerations when accessing and participating in Medical Imaging research. It follows a workshop session with patients, public and medical imaging experts on 29th November in Nottingham.

Who is the report for?

The report is for Medical Imaging researchers, those organisations and individuals whose role it is to support and help facilitate imaging research, and patients and the public interested in or who encounter medical imaging. It aims to give rise to further discussions and insights amongst these audiences.

Brief introduction

There has been a great deal of scientific work recently on new and better ways of seeing what is going on inside people’s bodies in order to improve medical diagnosis and treatment.  Medical Imaging includes techniques such as  x-ray imaging, nuclear medicine, ultrasound and MRI scans. Medical imaging is at the forefront of scientific advances, including artificial intelligence, which offer great potential for patient benefit.

The national Imaging Project led by the government funded NIHR has developed a programme of work to accelerate the translation of scientific advances in imaging by working to improve the capacity and delivery of imaging-related research in the NHS. Further information about this one year project can be found in Appendix 1.

The NIHR exists to support research that is centred on patient benefit and from the beginning of the Imaging Project it was recognised that it was important to understand the issues and opportunities for patients when encountering the new Imaging technologies in the context of applied research in medical care environments. Therefore it was agreed to begin to scope out these issues through a workshop event with a small number of patients and public. The event was made possible through a joint effort between the NIHR’s Nottingham Biological Research Centre and the NIHR.

The workshop took place on 29th November. There were 16 patient and public workshop participants, 3 imaging experts and 2 event facilitators. A short, limited survey prior to the event provided some initial feedback as to what some of the issues might be and this helped to begin the discussion. The outputs were a range of identified themes and related recommendations which are the focus of this report. The workshop Aims and Objectives and Agenda are shown in Appendix 2.

A note on language used in this report:

• We refer to ‘research’ frequently and by this we mean finding out new information in a systematic way using scientific methods to answer a question. In Imaging Research this might mean a wide range of different kinds of question for example, how we can understand the images of the human body created by a new technology to make a reliable medical diagnosis, or how a new imaging technology can be best applied in real hospital environments.
• By ‘imaging’ we mean the creation of a visual representation of what is actually going on in a particular patient. Such images can produce a lot of data because of the way they are analysed or used together.
• We use the term ‘study’ or ‘research study’ to mean a particular piece of research designed to answer a particular question.
• By ‘participant’ we mean a ‘research participant’ - someone who has consented to take part in a research study. These may be patients or healthy volunteers or both depending on the question the individual study is attempting to answer.
• By ‘patient and public involvement’ we mean a method in healthcare research where members of the public and/or patients are actively involved in research projects and in research organisations.
• By ‘site’ we mean the place or range of places in which the research is undertaken with participants. These are most often healthcare settings such as doctors surgeries of hospitals. Some research studies have a large number of sites across the country whilst others may only have one or two sites in specialist NHS Trusts for example.

Brief summary of outputs from the workshop

Themes were identified through a stepped process involving small group discussions and whole room feedback/reflection sessions. Issues were first scoped and then the themes that emerged were then prioritised through a voting exercise and then recommendations made. In order of priority the 7 themes were:

Theme 1. Communication throughout

• Summary:
  • Timely and respectful communication along the whole patient pathway before, during and after the imaging intervention is important.
  • It needs to  include ’who’, ‘what’, ‘how’, ‘when’ and ‘why’ information in forms accessible to individual patients including options for written (plain English), pictorial representation and verbal dialogue.
• Type: Cross-cutting principle

Theme 2. Access and Inclusivity

• Summary:
  • The research process, the technology and the design around each should be inclusive and accessible to reflect the whole population.
  • Design needs to incorporate responsiveness to a wide range of patient medical needs and preferences. This is particularly important where circumstances are likely to be anxiety producing.
  • N.B It was also pointed out that new technologies should be driven as much by patient accessibility as efficacy in patient diagnosis.
• Type: Cross-cutting principles

Theme 3. Streamlined patient pathway

• Summary:
  • Timely sessions taking into account individual patient need, for example - outside commitments, disabilities or concurrent medical conditions.
  • Avoid too much waiting time and be clear about communicating what happens next. Ensure all professionals along the pathway are suitably briefed.
• Type: Cross-cutting principle

Theme 4. Imaging Results

• Summary:
  • Clarity from the beginning about the results of scans - whether and how these will be fed back to the patient and their healthcare practitioners.
    Where results can be reported (whether positive or not), avoiding long waits for the patient.
  • Being clear about what will happen when there are incidental findings (e.g. identification of an  unexpected condition) is a serious ethical issue.
• Type: Specific issue

Theme 5. Consenting implications

• Summary:
  • Having clear accessible information about what will happen and not happen before consenting so that expectations are clear.
  • Opportunity to ask questions and discuss as care is needed in balancing patient needs with research needs before consent is made and how data will be used and shared. This is particularly important in imaging research as the imaging may not be informative about the patient during the research but may be informative about the technology so that it can eventually be developed to benefit patient diagnosis in general.
• Type: Specific issues

Theme 6. Data interpretation and sharing

• Summary:
  • Importance of being clear about how imaging data will be used and shared. It informs choice based on what the likely wider benefits of the research might be and the balance between individual benefit and privacy.
• Type: Specific issues

Theme 7. Environment

• Summary:
  • The physical and sensory environment in which imaging research happens is important to patients.
  • Noise, temperature, general comfort, equipment adaptability, and ambience is important to patients whose anxiety levels can be high when faced with machinery and technology that is unfamiliar. E.g. Claustrophobia induced by being in an MRI scanner was particularly noted
• Type: Specific issues

Clearly these themes are interrelated:

• access/inclusivity - connected to consenting implications; communication; environment; streamlined patient pathway
• communication - connected to access/inclusivity; consenting implications; environment; results of scans; streamlined patient pathway
• consenting implications - connected to access/inclusivity; communication; data interpretation and sharing; results of scans
• data interpretation and sharing - connected to consenting implications; results of scans
• environment - connected to access/inclusivity; communication; streamlined patient pathway
• results of scans - connected to consenting implications; communication; data interpretation and sharing
• streamlined patient pathway - connected to access/inclusivity; communication; environment;

A diagram attempts to make some sense of these connections; for example, Communication has the 5 connections; Access/inclusivity and Consenting each have 4. This reflects the centrality of the theme in the imaging research system. However, every theme concerns patient centrality in respect of imaging research. In the final workshop session on recommendations it became clearer how these themes were cross related and needed to be seen as a whole real-world working system. Something that cut through all these themes was the need to avoid or minimise anxiety for research participants in this sometimes unusual area of technologically driven research.

The unique context of imaging research and its implications for participants

Some of the themes in the summary could apply to undertaking research in general, and in some respects echo feedback the NIHR has had from previous research participant surveys; for example, the patient pathway, communication and to some extent environment. But there was a distinctly different emphasis that came out of the Imaging workshop, so it is important to be clear about how the themes specifically relate to imaging research.

There may be a number of reasons for this difference. For example:

• 1. Imaging research is generally not medical-condition-specific. It is about improving the ability to look at what is not normally visible in the human body in order to improve the accuracy and speed of diagnosis and treatment across a range of conditions.

• 2. Imaging research is a range of types of study that may or may not directly benefit participants. For example, it might be focused more on understanding how new scientific techniques show the body on screen and how to interpret this for accurate medical diagnosis. Alternatively, it may be about how the new technology supporting this science is best applied in the real world patient care environment as opposed to the laboratory.

“Patients often think agreeing to research projects will improve their chances of extra care, treatment and checkups, which is reassuring for them if not always the case.”

• 3. A lot of data is gathered quickly in imaging research and this has implications where real people are involved who may not directly benefit from this data. How are expectations to be made clear about how data, which may be significant to a private individual, is used and communicated? There can be important ethical issues.

• 4. A particularly important area identified were ‘incidental findings’ where medical conditions separate from the intent of the research study come to light that the study participant was not aware of. This is a critical issue to consider at design, ethics approval and in individual research site set ups because it has important research ethic implications. Should the patient be informed of incidental findings or not? Will they be told if they will be informed or not consenting to take part in the study? Should all study protocols include arrangements for ‘incidental findings’ to be fed through to the patients clinical radiology team for an opinion when appropriate?

“I feel VERY strongly that incidental findings should be followed up.”

• 5. New imaging technologies being researched are by definition ‘unusual’ or even strange to individuals who encounter them. They need particularly thorough explanations in order to avoid confusion and potential anxiety.

“Re: MRI scan - told to bring a CD but no hope of hearing in the noise. And it is very claustrophobic.”

• 6. The rationale for developing these technologies in medicine is, (especially where supported by the NIHR) about faster and more accurate diagnosis and treatment in medical practice that saves time for both patients and medical practitioners, improves efficiency and effectiveness of treatment pathways, and through early diagnosis even save lives. But they are not treatments in themselves.

“Always immediate results & not having to have several images done as in the past”

• 7. Imaging technology is driven forward by a range of people with a wide range of specialist expertise; for example, engineers, biophysicists, chemists, mathematicians, and medical scientists. The technologies may be new and exciting in the world of fast developing science but perhaps for this reason extra care is needed to ensure they are patient relevant and patient centric in the way they are designed, researched, set up and applied in medical care.

“Time and support to ask questions etc. before and after using new tech.”

Making recommendations

When looking at the outputs of the workshop it is important to present them in a way that is most useful to those who can influence or implement improvement. The key audience for this report are those who are involved in real-world conception, planning and organisation of Imaging research studies for patient and participant benefit. These will include Imaging study teams and those on site supporting studies in the NHS and beyond. It also gives direction for future patient and public involvement practice and future involvement and engagement.

We also need to bear in mind that people developing and undertaking research may not be exclusively ‘professionals’ but also patients and public who may be actively involved in helping to ensure that studies and the way they are carried out are patient focussed throughout the research study.

It might then be useful to present and interpret the themes in terms of the following:

• The research pathway from first idea to reporting study results.
• The wider context of technology development and application in the real world of patients.

“The way the staff verbally explain things to patients, as how it's explained to you makes such a difference in helping put you at ease.”

Idea Stage

Themes applying:

• Access/inclusivity
• Data interpretation and Sharing

Carefully consider:

• Involving patients in the initial ideas to ensure relevance and focus for best patient care.
• From the beginning, consider benefits when scan data is used with other data already available e.g. demographics, for maximum patient benefit

Technology Design Stage

Themes applying:

• Access/inclusivity
• Streamlined pathway

Carefully consider:

• Active patient involvement to ensure patient centred ergonomics.
• Design that is adaptive to the individual rather than individuals needing to adapt to the technology (hardware and software)
• Design that supports a smooth pathway for patients

Study Design Stage

Themes applying:

• Communication
• Access/inclusivity
• Streamlined pathway
• Individual imaging results
• Consenting implications
• Data interpretation and sharing
• Environment

Carefully consider:

• Include patient communication plan
• Patients in co-design of study information sheets.
• Patient involvement to help design and incorporate a wide range of patient needs.
• Avoid arbitrary inclusion/exclusion criteria which are not based on the science.
• Map patient pathway in design of research - including key contact and communication points.
• Clarity about the ethical implications, particularly where there could be incidental findings in patient scans.
• Consider patient choice around knowing results and data use and storage.
• Consider all themes in this report for incorporation into a consenting checklist.
• Plan for conducting the research study in comfortable, helpful environments mitigating participants’ anxiety levels.

Research Management (site level) Stage

Themes applying:

• All

Carefully consider:

• Clear engaging information about opportunities to take part in imaging research in a range of formats, spoken, written and visual, thus providing patient choice.
• Be clear as to the type of study e.g. does it include diagnosis or is it simply a study to understand how the imaging technology interprets known conditions?
• Use plain English in consent forms and adapt associated discussions to the needs of the individual and providing the time they need for making a decision.
• Careful whole medical assessment to identify potential risks associated with imaging interventions.
• Be clear how individual data is to be interpreted and shared with others (privacy).
• Make it clear to patients from the start what will happen to individual results - how and when they will be communicated in that particular site.
• Avoid a long waiting time where individual results are to be communicated.
• Make clear at all points that a patient can withdraw from the study at any time - very important where there are anxieties in relation to actual experience with the technology.
• Communicate data sharing plans and how data will be used to create benefit.
• Focus on patient centred pathway via ‘dry run’ walk throughs prior to starting a study.
• Timely explanations at key points during site visit and during the life of the study
• Tailor processes to the individual wherever possible
• Avoid long waits but consider rest time. Use texting etc. to provide notifications and reminders.
• Consider mitigation of anxiety levels by avoiding noisy,  inhospitable environments not well adapted to individual need.

Research Reporting Stage

Themes applying:

• Communication
• Access/inclusivity

Carefully consider:

• Report all outcomes clearly so all participants can understand them.
• Accessible formats options offered

“Reducing the amount of fluid needed to create a contrast as when ill you just can't stomach it.”

“Waiting a long time for (scan) results to make it to your doctors and then them not telling you the results - even if everything was ok.”

It is evident that the majority of issues raised during the workshop relate to the study management stage of the research as this relates to what happens at site level, where the imaging research and the patient/participant come together. As stated earlier, some of the issues raised relate to most kinds of research and may already be expectations in statutory research governance but there is no harm in these being restated as they may have particular emphasis in imaging research. It would be of value therefore to consider checklists for study site teams relating to imaging work in particular. A recommendation to this effect is made later in this report.

However, what happens at an individual site is also influenced by the overall design of the research study in the first place in terms of its ‘patient centricity’. There is an important link between this earlier stage and the actual experience of patient participants during the study.

There is also a further consideration that arose from the workshop and this has more to do with the strategic application of new imaging technologies in the everyday world of patients and public not just the institutions and the way they currently provide health diagnosis and care.

The wider context of technology development and its application in the real world of patients.

There were some clear messages from the workshop about how new technologies were being developed and the assumptions from drawing board to construction about patient and public need in the way the health services are delivered in future rather than how they are now.

1. Right from the start imaging technologists should consider the strategic context in which the imaging technology might be used for health analytics. Health strategists might helpfully be involved as well as patients and the public. Technological advances lend themselves to miniaturization and connectivity and rightly focussed could help bring imaging technology to where people are rather than the health institutions people are expected to attend. A current example is how breast screening is brought to communities through the use of road trailers.
2. The technologies could further be designed to adapt around the individual patient rather than the patient having to adapt unduly to the technology and its processes. Individuals come in all shapes, sizes, ages and backgrounds and with different physical, emotional and cognitive needs. Individual patients are likely to have a range of health issues not just a single issue. Adaptive technology can help promote equality of healthcare access for individuals.
3. Linked to this is that the workshop identified that anxiety in encountering new technologies runs through all discussions. This can be mitigated by the technology design itself to some extent if it is focussed around the people whom it is designed to benefit as much as the health conditions they bring.

Conclusions

The themes and issues raised in relation to Imaging research as patients see it should guide how the concepts and processes of Imaging technology development is done and how it is to be applied so that it benefits patients. The workshop discussions surrounded a tacit agreement that imaging technology is a good thing because of its potential for early diagnosis and subsequent effective and timely treatment.

Where there were issues, these focussed on how imaging technology is developed and applied in research and in the real world of patients both collectively and individually. Key to this are:

• The way imaging technology and research on it is communicated.
• The design of the technology itself and the assumptions behind it.
• The processes by which imaging research is undertaken.
• Consideration of ethical and consenting implications of ‘incidental findings’ and patient data sharing.

The NIHR is focussed on research which benefits patients and so understanding the impacts of new developing research on patients is very important. Imaging research needs to be patient centred (the person, not just the disease requiring assessment), otherwise the realisation of the significant potential of this new technology in medicine may be slow. There is no advantage to imaging technology developers, researchers, medical care staff and above all, patients in this.

The outputs of the workshop and the points in this report are therefore important to take forward to those who can influence for best processes and approaches. But underlying this is the need to involve patients at the outset in concept, technology design, research design and communication to get it right.

The report therefore should be considered as a starter for further work in this field which we hope centres supporting imaging development and research can take forward.

We are not aware that any previous similar work with patients and public has been done for medical imaging. The workshop and the report therefore cannot be expected to cover all the details needed. Rather it should be treated as a foundation on which to build.

Recommendations for next steps

1. Consider the development of an easy to use checklist for imaging researchers, imaging research teams based on the table in Section 4 of this report.
2. Develop guidance for communicating imaging research easily and well.
3. Ensure all imaging researchers are aware of the guidance provided  by NIHR INVOLVE on actively involving patients in research as ‘co-producers’.
4. The Health Research Authority to consider implications of the ethical issues concerning communication of incidental findings in patient scans during imaging research and if appropriate, provide guidance.
5. Dissemination of this report through:
   1. NIHR infrastructure
   2. All Imaging Researchers and patient groups associated with these centres
   3. The NIHR Imaging Group for further cascade
   4. NIHR INVOLVE
   5. NIHR E-Newsletter
   6. Health Research Authority

Thanks

Firstly the NIHR Imaging Project group would like to thank all 16 of the participants in the workshop for their commitment and efforts in carefully considering the issues for patients and public and share their personal experiences and insight. Further, our thanks to participants for commenting on the drafts of this report and suggesting changes. This has enabled us to produce a pragmatic report that will usefully influence the Imaging Research community toward continuously improving best practice in the patient interface with their work.

We would also like to thank the professional imaging experts for giving their time to help contextualise the discussion with their knowledge of recent developments in imaging technology and research.

Special thanks to the NIHR Nottingham Biomedical Research Unit for hosting and lending staff resources to support the workshop. Particular thanks to Kate Frost for her part in planning, participant liaison and co-facilitating the workshop.

Roger Steel, Workshop Coordinator, February 2020.

Appendix 1: The NIHR imaging project background and objectives

Background

Imaging is clearly key to much of modern medicine, driven by scientific developments which are wide-ranging and proceeding at pace. The NIHR is active in imaging research across all elements of the NIHR infrastructure; the Biomedical Research Centres (BRCs)  and Medtech and In Vitro Diagnostic Cooperatives (MICs)  in developing new techniques, and the Clinical Research Network (CRN), the NIHR Clinical Research Facilities (CRFs) and the Experimental Cancer Medicine Centres (ECMCs) in delivering studies.

The existing NIHR programme in imaging has highlighted that there is more to be done to develop and deliver imaging research, and that such activity will have considerably greater impact if undertaken across the NIHR infrastructure. A ‘one NIHR’ approach will help strengthen collaborations with key national partners, including UKRI, HDR-UK, UK Biobank, and NCRI, by presenting a more consistent and coherent NIHR perspective.  Recent and planned development in key areas of science, including Artificial Intelligence (AI), strengthen the case for a unified NIHR approach.

Summary of the project

The NIHR Imaging Project originated in 2015 as one of the Emerging Technologies and Innovations. In 2017, it became clear that, as noted above, much greater impact would be achieved if the remit was extended to include all NIHR experimental medicine infrastructure -the Biomedical Research Centres, Clinical Research Facilities and the Medical Technology and in-vitro Diagnostics Cooperatives.

• The overarching aim of the project was to accelerate the development, evaluation and clinical translation of novel imaging science by:
• supporting the development of the imaging research workforce
• developing new and stronger partnerships with industry
• working with key national partners, including patients and the public
• and streamlining processes required to set up and deliver imaging studies

The 6 Workstreams  with their aims are listed below

1. Workforce aimed to increase the capacity and capability of the NHS and academic imaging research workforce
2. Operational Processes aimed to improve the capacity and efficiency of existing NIHR clinical research imaging infrastructure in the NHS
3. Data Science aimed to support the development of improved methods of delivering imaging research studies including research element of rapid, secure shared access to large imaging datasets linked to cognate clinical data to support the development of AI and machine learning algorithms in imaging
4. Industry aimed to improve the NHS as an industry partner for imaging studies
5. Engagement & PPI aimed to increase awareness of NIHR in the NHS clinical imaging community and to involve patients and the public in imaging research
6. Communications aimed to create a portfolio of appropriate Imaging case studies and a slide deck for use by NIHR Imaging researchers in their educational, ambassadorial and promotional roles

Objectives and outputs

The overarching aim of the project is to accelerate the development, evaluation and clinical translation of novel imaging science by:

• supporting the development of the imaging research workforce
• developing new and stronger partnerships with industry
• working with key national partners, including patients and the public
• and streamlining processes required to set up and deliver imaging studies

 

Appendix 2: Aims, Objectives and Agenda of the workshop on 29th November 2019

Issues and opportunities on the patient interface with Imaging Research

Aims

To scope a range of issues concerning the interface between imaging research and patients, select priority areas and develop recommendations for further work.

Objectives

Develop and undertake a short pre event survey of imaging research teams and patients about the issues and opportunities where patients and imaging research meet. Record and distribute results.

During the event

• A scoping discussion with a mixed group of patients with and without experience of imaging research and imaging experts listing the range of issues and opportunities.
• Develop a hierarchy of issues and opportunities and prioritise.
• Focus on a small selection, discuss in depth and make recommendations for further work.

Disseminate a report of the discussion and request comments and views from the wider community of imaging researchers and patients.

Workshop agenda

Date: 29th November 2019

Time: 10.30 - 15.30

Location: Trent Vineyard Conference Centre, Unit 1, Easter Park Lenton Lane, Nottingham, NG7 2PX.

10.30 – 11.00am - Registration/ Tea and Coffee

11.00 – 11.15am - Welcome and Introduction to the day - Roger Steel, Kate Frost

11.15 – 11.30am - National Context of Healthcare Imaging Technologies - Steve Smye

11.30 - 11.45am - Local context of Healthcare Imaging Technologies - Nottingham Biomedical Research Centre and the Precision Imaging Beacon - Dorothee Auer

11.45 – 12.00am  - Coffee/Tea Break

12.00 – 12.45am - Initial Discussions (1) Results of the Imaging Survey/Poster Summary (2) Scoping Exercise and Discussions – what matters to you - Roger Steel, Kate Frost

12.45 – 1.30pm - Lunch

1.30 – 2.15pm - Prioritisation Discussions - From the morning discussions, which elements do you feel are the most important?

2.15 – 2.30pm - Coffee/Tea Break

2.30 – 3.15pm - Recommendations - Ideas session around potential solutions and recommendations to priorities discussed -

3.15 – 3.30 - Summary – Thank you and goodbye - Roger Steel, Kate Frost