This blog reflects the second workshop being held on this topic for the Joint Research Office a great partnership between UCL, University College London Hospitals NHS Foundation Trust, and Royal Free Hampstead NHS Trust. The course details can be found here and it is taking place as part of International Clinical Trials Day - ICTD.
This is additional module and my last for the Building Research Partnerships workshops supported by Macmillan Cancer Support.
The notes here are directed mainly at patients, carers and members of the public. The previous workshop and blog looked more at supporting researchers. Thanks to Ros Yu and Madeleine Stewart for all their help.
Involving the Public in Study Recruitment
As patients, carers and members of the public we are increasingly invited as contributors to the research process, actively involved in the design, delivery and dissemination.
This movement for change has helped with the push to get more people taking part as research participants. In cancer this has increased from around 1 in 25 people taking part in studies in 2001 to almost 1 in 4 more recently.
For those of us who become actively involved we would consistently state that the earlier we are included the likelihood of better research.
How might we best improve RECRUITMENT to research studies?
It is possible to identify three areas where wisdom can be brought to bear - that unique experience of being the patient, family, friends and colleagues OR the external perspective as a member of the public.
• SENSE – whether what is proposed matches what’s being recruited – providing the reality check that asks if the Emperor has no clothes.
• RELEVANCE – whether the study seems appropriate to patient experience and sensitive to their needs - considering the time, place and burden of taking part.
• LANGUAGE – whether the way the study is promoted is understandable – looking at the both the verbal explanation and the Patient Information Leaflet
Roles and responsibilities
First and foremost we must be clear about the context for involving people, why it is taking place and what is expected. The following questions are those we should be asking of each other...
· What am I doing here?
· What is wanted/needed?
· What is the task in terms of recruitment?
· How long will it take?
· Will anything happen as a result of our discussion?
· Will any changes be applied to this study?
· What learning will be applied to future studies?
· How are the findings being fed back to the researcher and to NIHR?
· How and when will we all be informed of progress?
· Is the evidence of involving people being recorded?
Some QUESTIONS to explore around Recruitment
What might we look for Sense, Relevance and Language in HINDSIGHT?
Questions that help us reflect and understand why people chose not to take part in the study
· Do you clearly understand the study?
· How relevant to patient need does it seem?
· Was the language used in the patient information leaflet appropriate?
· Were the targets unrealistic (ie the numbers expected and the time it took)?
· Was it a study that required extra visits to a clinic (burden)?
· Were people just not interested in the topic?
· Were there other problems associated with this particular study?
What INSIGHTS were offered earlier for Sense, Relevance and Language
Questions that explore the preparatory planning and design stages of the research
· What does it say in the section on Patient & Public Involvement (PPI) in the application form?
· Is there any evidence that the researcher has talked to patients with this condition?
· Have patients been actively involved in design and development of the study?
· Is there a plan for actively involving people throughout the study?
· If so, then why has it failed to recruit?
· How ‘lay’ is the lay summary?
Thinking about the INSIGHTS we might apply in the Future
LEARNING from Experience
Sense, Relevance and Language in the future - FORESIGHT
Considerations for helping researchers at an earlier stage
To think 'Patient'
To find out about patient self-help and support groups - especially on social media
To know about charities and other national/international patient organisations
To understand the continuum of patient involvement from consultation to partnership
To develop and sustain a plan for effectively involving the public
As patients and/or carers, it is of value to think far beyond our own experience and imagine what the public - those patients of the future might want/need. It is worth thinking about how technology and access to smart phones and tablets have dramatically increased in recent years.
So, how are might we use technology for Study Recruitment...
· Informing People about Research – The recent consultation on the UKCTG provided some useful information but we need to find other means of using U-Tube, Facebook, etc.
· Using Technology for Recruitment – Expressions of interest, eligibility, registration and capturing data about numbers interested, numbers recruited. Patient information leaflets could be given as an App to address a paperless concept to research.
· Maintaining the Delivery of Studies – Informing participants of appointments, compliance reminders, gathering patient experience, monitoring patient responses to trial treatments and safety reporting.