Feasibility versus Practicality, when it comes to research.
Feasibility, in research, often means "can the study be done?" E.g. are there enough patients of the type being studied? Do we have the necessary staff? Do we have the time and the resources?These are sensible and logical questions, and they are absolutely necessary as it would be entirely pointless to suggest running a study if the proper infrastructure was unavailable. In England, UK, the role of providing a significant part of that infrastructure is from the National Institute for Health Research - Clinical Research Network. It exists to ensure that studies are feasible, and up and running in an average of 30 days. From the patient perspective, one of the key factors is about the practical aspect of taking part. The simple day to day realities of being a patient are far more matter-of-fact. They involve the everyday, down to earth realities:
- Can I get to the clinic?
- Is there public transport?
- How much time will the extra tests take?
- Will I need to go to different parts of the hospital?
- Is the clinic up lots of stairs?
- Are there sign to tell me where I am going?
- What about car parking?
- Do the parking meters take cash?
- Do the reception staff know about the research?
Practicality is equally as important as feasibility. If we want to recruit participants to the agreed times and the achieve the target numbers then we have to address the needs of patients.
There is another aspect to all of this. The questions I have raised above are ones I have heard for years. But, why does research have to take place in a hospital or clinical setting? Why does much of it rely on person to person communication between a research team and the participants?
With the use of smart phones and other digital technology we need to make all aspects of research easier to use. Research has to adapt to people's lifestyle, be available closer to our home, related to our lifestyle needs and matched to existing wearable technology. These factors are the new feasibility. Technology must be more than giving information. It has to be interactive and engaging. There has to be more in it for the modern participant than reminders of appointments.
We have to pay more attention to explaining why people should give up their time, ensure their participation is acknowledged, and allow them to know the findings of the study.
It would be much better if we planned for these problems at an earlier stage. Here are some ways of doing this:
Talk to and involve some patients during the planning and design stage of your research.
- Pay particular attention to the language in the lay summary, any posters and the inclusion and exclusion criteria, the recruitment plans, etc. There is no point in having a study that is 'feasible' if no one thinks it is relevant and won't take part!
- Ask their opinion e.g. on the recruitment strategy. A study set in a hospital is little use to people living in a care home.
- Be informed by the what the patients tell you about their needs, experience and knowledge and make the necessary adjustments
- Think now about how technology could be used to make the study more attractive, easier to join and maintain a long term relationship
For Delivery Teams
- Find a local patient community/group or panel (Talk to someone in PPI or an engagement team)
- Walk through the study from the invitation to participate, the arrival by public transport/car, the walk though the doors, reception as a means of road testing the barriers.
- For more complex studies you may want to do as Guy's and St. Thomas' Hospitals by preparing leaflets with maps explaining the various places
- Consider how technology could be used to capture patient experience of studies
- Check whether patients have been actively involved in the development of the study
- Ask whether adaptations were made to make the study both feasible and practically suitable
- Encourage greater use of adaptive studies and technology as a means of interacting with participants
ClinEdge walks through the answers to some of these proposed questions in our webinar on planning for a rare disease trial. Watching the recording on-demand now.
Post by Derek C Stewart -
Born too many years ago in Ayr, Scotland Derek was treated successfully for throat cancer in 1995. A former teacher Derek became involved in numerous aspects of patient involvement and advocacy at a local, regional and national level being the founder Chair of the Consumer Liaison Group for the National Cancer Research Institute. Currently, Derek is the Associate Director for Patient & Public Involvement and Engagement at the National Institute for Health Research - Clinical Research Network (NIHR CRN) for England. Also Director for Patient & Public Involvement at Nottingham Biomedical Research Centre. In the charity sector Derek is a Member of Cancer Research UK and is a director at Derek C Stewart Associates Ltd.