“There’s always time to work with patients” - patient and public involvement during the rapid development of a Long Covid treatment trial

Throughout the COVID-19 pandemic, timely research has been vital to understand how to treat this illness. Doctors developed a good understanding of the initial symptoms of COVID-19 and how to treat them. However, less is known about the longer-term effects. Around 20% of COVID-19 patients develop new or worsened symptoms following their initial infection. This is known as Long Covid, and can often impact the heart, lungs and circulation.

The HEAL-COVID trial was funded by the NIHR and supported by the NIHR Cambridge Biomedical Research Centre. It was set up to compare different treatments that could prevent or reduce the long-term symptoms in COVID-19 patients. Participants would be given one of two treatments or continue with their current care. They would then report back on their symptoms over a 12 month period.

While public involvement in research can sometimes be treated as less of a priority than other activities when time is limited, this was not the case in the HEAL-COVID trial. The trial was set up rapidly, like other COVID-19 research, but the team prioritised the involvement of patients and the public throughout its design and implementation. They allocated a clear budget for it, knowing that this would be vital to the study’s success.

While researchers are experts in their field, patients and the public have lived experience. This makes them essential partners for designing research which is relevant, high quality and able to positively impact health and care treatments and services. Research will have the most impact when people with lived experience of a disease or condition (directly or as a carer) are involved. Only they will know how it affects them and which symptoms bother them the most, and they will have important insight into how other potential participants may feel about the trial. This will give the best chances of recruiting and retaining participants. 

The team had to work quickly, collecting input into the design of the trial over the space of 2 to 3 weeks. First, they reviewed all available literature on symptoms of Long Covid to establish the most concerning symptoms to patients. In this way they ensured the contributions of patients who had already shared their data were honoured. They then partnered with the established Cambridge University Hospital (CUH) PPI group, and connected with other patients groups later. As widespread testing for COVID-19 was not available when the trial was set up, they could not establish if these group members had lived experience of COVID-19, or quickly identify public contributors who had. However, the CUH-PPI group members all had a mix of chronic conditions and acute experiences, including some respiratory illnesses such as asthma and chronic obstructive pulmonary disease. In this way they were able to use their lived experience to benefit the trial development.

THE CUH-PPI group was able to give rapid feedback on patient-facing written materials and website text. They also supported the research team to select the questions for trial participants to answer about their symptoms. These are known as Patient Reported Outcomes Measures (PROMs). As one of the symptoms of Long Covid is fatigue, the public contributors pointed out that the last thing a trial participant would want to do is complete a huge questionnaire when they are struggling with this condition. As a result, the team significantly reduced the number of questions patients needed to answer.

The team were careful to be sensitive to the disproportionate impact of COVID-19 on minority populations. For example, PROMs were translated into Polish, Panjabi, Urdu, Bengali, and Gujarati and participants could answer questions online or via phone. To date, the racial and ethnic makeup of HEAL-COVID participants matches the latest UK census, bucking the trend that UK clinical trials typically recruit mostly White British participants.

Making impactful changes

The public contributors also supported the trial team to develop training videos. These guided researchers in how to ask patients to take part in the trial. Public contributors made many valuable comments to improve the scripts. For example, in one script, a researcher states ‘so if you don’t have any questions..’, assuming that they have covered everything the patient might need. One public contributor highlighted that you should always ask patients if they have questions, and change the wording to be more open. In another video, it shows a researcher standing by a patient’s bedside when taking consent to be in the study. Public contributors suggested that to remove the power dynamic, the researcher should be at eye level. These changes might seem small, but can make a huge difference to how patients feel.

“I think as a member of the public that has suffered the effects of covid like a lot of people, it is nice to be able to bring a patient perspective into the mix and be able to say how it feels for us, and it’s nice to think we are helping by adding our opinions, this means that people from all different backgrounds are heard.” - Antonica Fletton, Patient Steering Group member.

The CUH-PPI group was very influential in the trial design. They helped researchers to explore different areas when there wasn’t an obvious route forward. For example, there were different opinions on how long participants would be happy to report their symptoms after leaving hospital. To understand this, the team randomly assigned participants to either report for 4 weeks or 12 weeks in a study-within-a-trial (SWAT). They then monitored the attrition rate to see which length of time was most appropriate, and the results will be shared publicly soon.

Generosity, camaraderie and tenacity

The success of public involvement in this rapidly developed clinical trial was down to the generosity of colleagues and the public contributors involved. Doing frontline research in the time of COVID-19 inspired a sense of camaraderie and shared endeavour. Activities that might take months were now taking weeks or days. The team were clear it was important to not let perfect become the enemy of good but recognised there is always room for improvement in their PPI approach. They worked with public contributors through the trial to make improvements and ensured enough time and resource was allocated to achieve meaningful involvement. The team was tenacious in ensuring an appropriate budget for public involvement was allocated and have recruited two public contributors with lived experience of COVID-19 to the steering group. In this way, they directly interact with and influence the researchers as the trial continues.

Throughout the trial they have hosted the HEAL Covid website. This is a public website and shares lay summaries and infographics of the research aims. This also shows live updated recruitment numbers, social media, and the trial documentation for anyone to read at any time. The HEAL-COVID trial team are continuously looking for ways to work better with patients and the public to help maximise the impact of the study. One area the team is keen to continue improving is the  diversity among trial participants. They want to understand the barriers that might exist that prevent people from enrolling. These might be research scepticism or the time commitment required. This will be vital to ensure more people from all walks of life take part.

“PPI is no longer new, no longer an add-on, no longer a nice to have. It’s part of the job just like statistics or safety monitoring or contracting. The good news is that these interactions are likely to be some of the most useful, encouraging, and fulfilling parts of the design process. As things “go back to normal” we hope that the camaraderie, joint purpose, and spirit of collaborative research enabled by COVID will endure.” - Paul Wicks, PPI Lead, HEAL-COVID.

More information

The HEAL COVID study is funded by the NIHR (ref NIHR133788), and is led by Professor Charlotte Summers and Dr Mark Toshner, both from the University of Cambridge. Sponsored by University of Cambridge and supported by NIHR Cambridge Biomedical Research Centre.

Useful links

• If you are interested in involving patients and the public in research you can start with our briefing notes for researchers
• If you’re interested in getting involved as a member of the public, get started with our Starting Out Guide
• More information about the study is available on the NIHR's Funding & Awards website or on the HEAL Covid website