- If you are new to patient and public involvement (PPIEP) it might be difficult to understand how you can get involved or contribute to our projects.
- If you are a company/researcher, you may find it difficult to understand how public contributors will add value to your project.
The involvement of public contributors:
- helps map the patient journey from the patient perspective.
- helps identify areas that will improve the patient experience and outcome.
- helps with assessing patient engagement ambition and strategy.
Below are some examples of how public contributors add value to projects.
Projects
Study Investigating the Potential of a Rectal Mucus Sample for Development of Biomarker Assays in Subjects with Colorectal Cancer and other Gastro-intestinal Diseases (Industry Collaboration)We were approached with a request to support the clinical evaluation of this device. The company requested a patient review of their study documents which included the study protocol, the patient information leaflet and the informed consent form. The review conducted by our patient members included:
- Recruitment strategy (including inclusion and exclusion criteria)
- Consent method/approach
- Timing and location of data collection points
- Outcomes and measures
- Burden and fatigue issues (is too much data to be collected?)
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- Comment on participant information sheet/consent form
This was a collaboration between a surgeon and an established company to look at results from our dataset regarding stoma patients in the community and to develop a manuscript for submission. The team requested ileostomy patients as part of the writing group. They also wanted to involve public contributors to help them define the research questions from this dataset. Our public contributors:
- Became co-researchers
- Interpreted data
- Advised on how to disseminate to appropriate lay people and organisations
- Wrote lay summary of key findings
Public contributors were invited to take part in a survey for the Core Outcomes for early pHasE Surgical Innovation and deVicEs (COHESIVE) study.
The researchers were undertaking research to develop better methods for selecting, measuring and reporting outcomes of surgical innovation. The COHESIVE study wanted to develop reporting guidelines and a core outcome set to improve monitoring and reporting for the safe introduction of new surgical procedures and devices.
The aim of this project is to conduct a first-in-human feasibility study with our robotic platform that may provide a painless and easier-to-use alternative to conventional colonoscopy. Public contributors are part of the project team (co-investigators) and have already contributed by suggesting that patient experiences are recorded via audio/video instead of using questionnaires, and offering pain relief as standard to all patients. In addition they also advised on:
- Recruitment strategy (including inclusion and exclusion criteria)
- Consent method/approach
- Timing and location of data collection points
- Outcomes and measures
- Burden and fatigue issues (is too much data to be collected?)
- Ethics application (lay summary)
- Interpretation of data (in some instances)
- Membership of Steering Committee
- How to disseminate to appropriate lay people and organisations
Gastrointestinal recovery is something that is often measured in research studies. It describes the recovery of bowel function after surgery or after an episode of small bowel obstruction (often called a blockage). At the moment, researchers measure this in many different ways, which makes it difficult to compare studies or to test new treatments. The researchers hope to develop a “core outcome set”, which aims to standardise how researchers measure this in the future so that comparisons between studies becomes easier, and improve the value of research. Public contributors were given the opportunity to complete a set of surveys rating a list of outcomes related to the condition.
Patients having major surgery are at high risk of complications. Identifying complications early makes them easier to treat and improves the results for the patient.
One of the ways patients are monitored for complications is by charting their vital signs: blood pressure, pulse, breathing rate and temperature. A nurse will usually check these signs every four hours in the first few days after surgery. The vital signs form a score, the National Early Warning Score (NEWS), which can detect if the patient becomes unwell. One of the problems with NEWS is that patients can deteriorate in the intervals between monitoring, which can delay vital treatment.
One solution to this problem is continuous monitoring. A wireless patch is worn on the patient’s chest to monitor heart rate, breathing rate and temperature continuously. This could help detect unwell patients earlier.
In order to test this theory, a study was conducted comparing a continuous monitoring system with NEWS monitoring. The research methods were tested in a small study first, called a feasibility study. The main aim was to provide information about how best to undertake a larger study to fully test the new monitoring system.
Public contributors were invited to be part of the Trial Steering Group that would ensure that the patient perspective was included in the trial protocol. They also advised the researchers on:
- Feasibility of randomisation
- Content of control arm
- Recruitment strategy (including inclusion and exclusion criteria)
- Consent method/approach
- Timing and location of data collection points
- Outcomes and measures
- Burden and fatigue issues (is too much data to be collected?)
This project wants to explore how healthcare professionals will use this app in clinical practice and where it fits in with the clinical pathway. This will also involve looking at health economics. Public contributors are part of the project team and they are contributing to the data analysis by guiding and identifying themes.
Grant Funding Applications
NIHR Funding Calls - RfPB, i4i, EME, HTA and otherThe NIHR expects active involvement of patients and the public in the projects it supports, and evidence of early engagement must be presented on the application form. We identify appropriate public contributors for the project, and will engage with these public contributors at an early stage. Their input can range from being a co-collaborator to writing the plain English summary or reviewing the application form to ensure the patient perspective and/or experience has been captured.
Public contributors will ensure that the plain English summary is a clear explanation of your project. The plain English summary is often used to inform reviewers, including experts who might not have specialist knowledge of your field as well as members of the public of your funding application. If your application for funding is successful, the summary may be used on the SBRI Healthcare website.
This funder’s application form is similar to a business plan. If your application concerns a technology that is patient facing or will be used by the patient, then our public contributors can help you make sure that your innovation relates to the need or challenge you described, they will help articulate the impact this project will have and also help you consider the benefits if the application is funded.
These funders support fundamental and applied research at the earliest stages in the development of any new technology, and so the applications tend to have an academic focus. In most cases the HRC team will review the application to ensure that opportunities for future PPI and engagement are not missed.
Focus Groups
Product/Technology Development
Clinical validation case study
A MedTech start up approached us with an artificial intelligence (AI) concept for surgical theatres. The healthcare professionals were already sold on this concept, however we suggested to the start up that they consider a patient focus group as their AI concept was addressing patient safety. We hosted the patient focus group for the start up and whilst the patients gained a better understanding of the intended use and benefits of this AI concept, the start up was gained additional ideas to incorporate into later versions of the concept, which will be patient facing.
A MedTech start up approached us for support with the product development process and navigating the MedTech landscape. The start up had prototype which they were looking to refine and we suggested that they take our offer of hosting a patient focus group, as this device would be used directly on patients. The focus group enabled patients to ask questions about the device, perceived risks and potential areas to improve to make it more acceptable to patients. The focus group consisted of individuals that had either worked in this medical specialty or individuals that had experienced that specific procedure. The patient were introduced to a new device and were able to contribute to its improvement, whilst the start up received a comprehensive report which captured the discussions and had action points to address.
A MedTech start up from Hong Kong was referred to us to obtain support for the generation of clinical evidence for a faecal incontinence device. We set up a patient and clinical focus group to introduce the device to both clinicians and the patients. This provided the start up with confirmation that this device would certainly be more desirable than other invasive methods. Our public contributors were also able to contribute to discussions on how they would evaluate this device and what the start up would need to consider. The patients all had lived experience of faecal incontinence and would be able to help the start up with publicising the clinical study and advising on how best to recruit participants. This infomation together with that from the clinicians was used to develop a clinical study protocol. The trial will commence once the COVID-19 pandemic is under control.
Events and Workshops
National ConferencesWe sometimes host events that have a panel of experts who provide their perspectives of specific topics related to the event programme. We involve our public contributors by giving them the opportunity to represent the interests of the end-users, and to also ask those hard questions about certain assumptions.
Surgical Imaging Clinician and Academic Exchange – the purpose of this event was to generate ideas with the aim of setting up collaborations for the most viable concepts. Public contributors were invited to attend this event and were actively involved in the Identification of collaborations to take forwards
Physics of the Gut Workshop – the purpose of this event was to prioritise concepts to take forward for prototype development and to also produce a position paper for stakeholders. PPI representatives from the main research charities in this field were invited to speak and participate.
Parliamentary Launch Event – We received complimentary tickets for this event on “Introducing an Innovative Cancer Care Fund” and these were offered to PPI Group members who were interested in developing their knowledge and experience in this field.
Automated micro anastomosis for ultra small vessels – we hosted MedTech startup seminar where they could present their concept and work to our academics and clinicians. Public contributors were invited to attend if they had an interest in this area, and those that attended had the opportunity to talk to our surgeons, academics and the startup.