Increasing research in Real World Implementation
Martin Hunt, Programme Director of NIHR Invention for Innovation (i4i), writes about the i4i Challenge Award on Real World Implementation to support design and delivery evaluations of medtech innovations in real-world healthcare settings.
The NIHR i4i programme supports the advance of innovative ideas for high-tech products that will improve the diagnosis, treatment and prevention of diseases in the NHS in England. This year we are launching, for a second time running, the i4i Challenge Award on Real World Implementation to support design and delivery evaluations of medtech innovations in real-world healthcare settings.
Our aim is to tackle the evidence gap between the safety and efficacy studies typical of a newly or nearly CE marked technology and the evidence required to facilitate its uptake within the NHS.
But what exactly is research in Real World Implementation (RWI)? As Programme Director of i4i, I know that RWI studies can mean different things to different people. For example, to a clinical trial methodologist, a RWI study is a controlled trial carried out in pragmatic environments with relaxed exclusion criteria; to a clinician it might be a usability pilot, while to a commissioner it might mean an analysis of the financial commitment required to adopt a technology. This is because a new imaging scanner may incur significant service redesign costs compared to a simple decision-support digital tool!
In reality, Real World Implementation research covers all of the above. RWI is the practical assessment of a technology within a setting of intended use. The technology would have previously been tested for safety and efficacy, and proven through a CE mark for a medical device or in vitro diagnostic.
The type of research that i4i Challenge aims to fund will generate insights into three key areas:
Evaluating the changes required to slot the new technology into the patient pathway. This may include the re-allocation of resources (staff, facilities, consumables), the introduction of new payment mechanisms from the healthcare provider (should they want to adopt the technology) and technical or IT adaptations to accommodate the new tech.
Effectiveness in practice
Effectiveness (unlike efficacy – which are often used interchangeably) is about in-context validity or how applicable and relevant an intervention is to its intended setting. Here we are looking for evidence of technology performance in the exact care pathway where it will ultimately be used.
Any emerging complexities
This third area is just as important as the other two, because whenever something new is placed into an existing complex system (like the NHS!), there will certainly be opportunities to gather new learning to inform future implementations. We recommend reviewing literature from Prof Trisha Greenhalgh for more on this.
Often, real world evidence isn’t as robustly reported as pre-market (safety and efficacy) evidence. The NIHR i4i Challenge Award in Real World Implementation addresses this issue by promoting research in implementation, to ensure the above key areas are properly captured, reported and disseminated.
Finally, I’d like to encourage prospective applicants to consider how their proposed RWI study will support the financial impact of a decision to adopt or spread the technology, how it may inform NICE guidance and how it may confirm or disprove any of the claimed health outcomes. Therefore, any potential bias from the technology provider should be minimised through suitable collaborations with healthcare providers who should validate the proposed methods of the study.
Understanding how new technologies will work ‘in the real world’ is a crucial part of bringing benefits to patients - here at NIHR’s i4i Programme we’re excited to see what opportunities this year’s Challenge call will bring.
To find out more about the application process please head over to the Invention for Innovation Challenge Awards.
Martin Hunt, Programme Director of NIHR Invention for Innovation (i4i)
The views and opinions expressed in this blog are those of the authors and do not necessarily reflect those of the NIHR or the Department of Health and Social Care.