Genomics study identifies routes of transmission of coronavirus in care homes

Care homes are at high risk of experiencing outbreaks of COVID-19, the disease caused by SARS-CoV-2. Older people and those affected by heart disease, respiratory disease and type 2 diabetes are at greatest risk of severe disease and even death, making the care home population especially vulnerable.

Care homes are known to be high-risk settings for infectious diseases, owing to a combination of the underlying vulnerability of residents who are often frail and elderly, the shared living environment with multiple communal spaces, and the high number of contacts between residents, staff and visitors in an enclosed space.

In research published in eLife, a team led by scientists at the University of Cambridge and Wellcome Sanger Institute used a combination of genome sequencing and detailed epidemiological information to examine the impact of COVID-19 on care homes and to look at how the virus spreads in these settings.

In this study, researchers analysed samples collected from 6,600 patients between 26 February and 10 May 2020 and tested at the Public Health England (PHE) Laboratory in Cambridge. Out of all the cases, 1,167 (18%) were care home residents from 337 care homes, 193 of which were residential homes and 144 nursing homes, the majority in the East of England. The median age of care home residents was 86 years.

Compared with non-care home residents admitted to hospital with COVID-19, hospitalised care home residents were less likely to be admitted to intensive care units (less than 7% versus 21%) and more likely to die (47% versus 20%).

“Using this technique of ‘genomic surveillance’ can help institutions such as care homes and hospitals better understand the transmission networks that allow the spread of COVID-19,” said Dr William Hamilton from the University of Cambridge and CUH. “This can then inform infection control measures, helping ensure that these places are as safe as possible for residents, patients, staff and visitors.”

This is an abridged version of the press release which was first published on our website on March 3, 2021.

Single dose of Pfizer BioNTech vaccine reduces asymptomatic infections and potential for SARS-CoV-2 transmission

This implies that the vaccine could significantly reduce the risk of transmission of the virus from people who are asymptomatic, as well as protecting others from getting ill.

The study analysed results from thousands of COVID-19 tests carried out each week as part its screening programmes on hospital staff who showed no signs of infection.

The results were then separated out to identify unvaccinated staff, and staff who had been vaccinated more than 12 days prior to testing (when protection against symptomatic infection is thought to occur). The study found that 0·8% of tests from unvaccinated healthcare workers were positive, compared with 0.37% of tests from healthcare workers less than 12 days post-vaccination and 0·2% from healthcare workers at 12 days or more post-vaccination.

This suggests a four-fold decrease in the risk of asymptomatic COVID-19 infection amongst healthcare workers who have been vaccinated for more than 12 days (75 percent protection). The level of asymptomatic infection was also halved in those vaccinated for less than 12 days.

When the team included symptomatic healthcare workers, their analyses showed similar reductions. 1·71% unvaccinated healthcare workers tested positive, compared with 0·4% healthcare workers at 12 or more days post-vaccination.

This is an abridged version of the press release which was first published on our website on March 2, 2021.

Can a tapeworm drug boost protection from COVID-19 for high-risk kidney patients?

If the charity and industry-funded trial is successful, it may pave the way for a new treatment to prevent or alleviate the impact of Covid-19 in people on dialysis, people who have had a kidney transplant, and people with auto-immune diseases affecting the kidneys such as vasculitis who require treatment to suppress their immune system. The treatment will last up to nine months.

Patients on the trial will receive either a placebo (or dummy) drug, or UNI911 (niclosamide) as a nasal spray, both provided by the manufacturer UNION therapeutics, in addition to all their usual treatments. The trial plans to expand to other UK healthcare centres and aims to recruit at least 1,500 kidney patients.

Niclosamide has shown real promise in the lab, with early tests showing it could stop SARS-CoV-2 multiplying and entering cells of the upper airways.

Niclosamide has been re-formulated into a nasal spray and participants will take one puff up each nostril twice a day.

The trial will identify whether niclosamide can protect people from the virus either on its own, or in combination with any of the vaccines currently available.

If successful, this trial could mean that the treatment becomes available to kidney patients more widely within months.

This is an abridged version of the press release which was first published on our website on February 22, 2021.

Pfizer BioNTech vaccine likely to be effective against B1.1.7 strain of SARS-CoV-2

However, when the E484K mutation – first seen in the South African variant – is added, it substantially increases the amount of antibody required to prevent infection.

The preliminary data also suggest that a significant proportion of over-eighty olds may not be sufficiently protected against infection until they have received their second dose of the vaccine.

As the SARS-CoV-2 virus replicates and spreads, errors in its genetic code can lead to changes in the virus.

Towards the end of 2020, the Cambridge-led COVID-19 Genomics UK (COG-UK) Consortium identified a variant of the virus (now known as B1.1.7) and its emergence led to strict lockdown measures in the UK because of concerns over its transmissibility. There is particular concern that these changes might enable the virus to ‘escape’ the newly-developed vaccines.

The UK has begun rolling out two vaccines – the Pfizer BioNTech vaccine and the Oxford AstraZeneca vaccine. The efficacy of the vaccines can be boosted by a second dose; however, in order to reach as large a number of people as possible in a short amount of time, the government has concentrated on delivering a first dose to as many individuals as possible by giving the second dose at 12 weeks, rather than three.

Researchers at the Cambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID) created a synthetic version of the SARS-CoV-2 virus, known as a pseudovirus. They found that the Pfizer BioNTech vaccine is likely to offer similar protection against B1.1.7 as it does against the previous strain of SARS-CoV-2, however it may be less effective when dealing with E484K mutation, which so far has only been seen in a relatively small number of individuals.

This is an abridged version of the press release which was first published on our website on February 2, 2021.

DHSC statement on prioritising research studies and deploying NIHR CRN-funded staff

We recognise that at the current time those working in many NHS sites are under huge pressure as the number of COVID-19 cases and admissions to hospitals continue to rise and frontline clinical staff are unable to work due to sickness.

While we have a small number of proven treatments and vaccines for COVID-19, more are needed to reduce transmission, reduce the number of patients that require hospitalisation and to improve outcomes for those that do.

It is therefore critical that at this challenging time we continue to recruit participants to our urgent public health (UPH) studies. The current levels of prioritisation for research studies, set out within the Restart Framework, still apply as follows:

• Level 1a (Top Priority) – COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP)
• Level 1b – Other COVID-19 UPH studies
• Level 2 – Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient
• Level 3 – All other studies (including COVID-19 studies not in Level 1a or 1b)

NIHR guidance for a second wave of covid 19 activity still applies and, as outlined, states that the deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front-line duties should only occur in exceptional circumstances.

The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical Deans of the UK.

Where NHS Trusts consider they need to redeploy staff to support the frontline this should only be done to support clinical activity during the emergency phase of the pandemic and we would expect them to return to their R&D roles as soon as possible, once the pressures on the system reduce.

As indicated by the Restart Framework, at the current time, we need to continue prioritise our support for the most urgent COVID-19 research as part of the response to tackle the pandemic.

At the same time we need to ensure we continue to try and maintain support to deliver non-COVID studies currently open on the portfolio, particularly those within Level 2. A system-wide Recovery, Resilience and Growth programme has been established which brings together the key partners across the clinical research ecosystem to ensure the UK is well-positioned to take a coordinated national approach to achieving the recovery of the UK’s clinical research delivery and restore a full, diverse and active research portfolio as soon as practicable.

Occupational risks of Covid-19 infection in NHS staff

We propose a study using anonymised national data from NHS’s electronic staff records (ESR) to explore the risk of sickness absence due to suspected Covid-19 according to ethnicity, professional role, sex and age and in relation to available antigen/antibody test results.

This will help us understand not only the differential risks of Covid-19 infection in health care workers but also the possible modifying roles of ethnicity, age and sex. We will also examine sickness absence for mental illness. In addition, in a limited number of NHS Trusts we will collect group information on hospital admissions, staff redeployment and the availability of PPE.

Accordingly the study will answer the following three questions among staff employed by NHS acute medical Trusts:

1. How have rates of sickness absence ascribed to suspected Covid-19 infection varied according to ethnicity, age, sex, and potential for occupational contact with Covid-19 as indicated by occupation and department? How are these related to available data on antigen/antibody test results?
2. How have rates of prolonged sickness absence ascribed to suspected Covid-19 infection varied according to ethnicity, age, sex, and potential for occupational contact with Covid-19 as indicated by occupation and department?
3. How have rates of sickness absence ascribed to mental illness and other causes unrelated to Covid-19, varied over the course of the epidemic as compared with 12 months earlier, and have changes differed by ethnicity, occupation and department?

The study duration will be six months.

EpiCov Research Database

The EpiCov database contains de-identified patient and NHS staff data from the Cambridge University Hospitals NHS Foundation Trust (CUH) Electronic Health Record systems, including scan images and laboratory results.

The database will include routinely collected information about patients diagnosed with COVID-19 or suspected of having COVID-19, and staff who have been tested for COVID-19. It will also include information about a large number of control patients who do not have a diagnosis of COVID-19.

This will allow comparisons of patients with and without COVID-19 infection who have similar symptoms to see if there are any important differences that might help us understand the best way to prevent, diagnose and treat COVID-19 infection.

Thousands of patients need to be compared to check if any differences found between them are related to age, gender or the season.

No direct personal identifiers (such as name, date of birth, contact details, hospital or NHS number) will be included in the database. All information will be extracted and de-identified through an automated process by the CUH Clinical Informatics Team who process patient data as part of their job role.

The database will facilitate a variety of research related to COVID-19 aimed at improving health, treatment or services. Research will include large data studies using advanced methods of analysis, such as machine learning, with the aim of learning about how to predict patient outcomes and the best way to treat patients based on their clinical information.

The EpiCov database will both enable local researchers to use the Electronic Health Record resource for important research, and also allow CUH to contribute well-curated data to other national and international COVID-19 projects and databases.

if you have any question about the database, please contact us on the email below:

Dementia and neurodegenerative disorders

Covid-19 research

Researchers began several new projects relating directly to Covid-19 and these are highlighted below. In addition staff ran phone clinics. The team collected and audited feedback from doctors and patients on the phone clinics; this is now being prepared for publication.

• Professor James Rowe set up a new covid research project to study the impact of the illness on brain health, using the special ultrahigh field 7T MRI scanner at Addenbrooke’s. No results are available yet.
• Professor Hugh Markus carried out a systematic review and meta-analysis of Covid-19 and stroke. Results to be confirmed.
• Three members of the Dementia team were involved in the set-up and delivery of the RECOVERY trial.

Continuing non-Covid research

The team continued where possible with non-Covid research, outlined below:

• Remote assessments of patients involved in our longitudinal PD/HD cohort studies (the PICNICS, ICICLE-PD and Parkinson’s Research clinic);
• Retrospective analysis of cohort study data, leading to a recently submitted paper on the relationship between early gut dysfunction and disease progression in PD
• Validation of a new Parkinson’s disease-specific questionnaire evaluating gastrointestinal symptoms (conducted remotely via posted questionnaires)
• Completion of analysis of human post-mortem data for our study investigating the role of neuroinflammation in PD (manuscript now being prepared for submission)
• Sleep in HD – remote assessments conducted throughout the lockdown period and review of data
• Pharma-funded and academic-led clinical trials – all assessments and follow-up visits were conducted remotely
• Efforts were put into the set-up of new trials in the pipeline, completion of paperwork, writing trial protocols and designing databases.

Supporting NHS staff and patients

Several of the honorary consultants (RAB; CWG, TR) joined the on call/ward rota for 3 months dealing with all neurology/stroke admissions to the hospital as all the neurology SpR were moved to COVID wards.

Clinical fellows were diverted to the wards and on call services to help with the impact on the NHS Trust.

Our honorary consultants and research nurses diverted their efforts to ensure continuity of OP services for some of the most vulnerable patients and families in the community by undertaking increased numbers of remote OP clinics.

The Evelyn Perinatal Imaging Centre

Its internationally-competitive programme of research brings together clinicians, engineers and physicists to develop new technologies to study the causes, detection and diagnosis of brain injury in newborns.

Located in the Rosie maternity hospital, close to the neonatal intensive care unit (NICU), postnatal wards and birthing suite, the centre houses a physics laboratory, clinical 1.5T MRI scanner and infant scanning room with dedicated MRI-compatible incubator, making it safer and easier to transfer sick and preterm infants.

The centre enables researchers and clinicians to study and care for critically-ill babies in their first hours of life, in an infant-friendly and safe environment. Enhanced clinical care means babies’ outcomes have the best chance of improving and also facilitates new lines of neuroprotective treatments.

Through its ties with the University’s Department of Paediatrics and with NIHR Cambridge BRC support, the Evelyn Perinatal Imaging Centre is playing a key role in developing neonatal neurocritical care (‘Neuro-NICU’), to improve the quality of care for newborn infants with congenital and acquired brain injury. The centre is also closely involved with The Next Generation Children project, which is undertaking whole genome sequencing on infants with altered neurology and seizures.

The centre has enabled a number of successful commercial, industrial and academic collaborations in Cambridge, London and Europe, including the development of a 3D optical imaging system and state-of-the-art EEG monitoring systems. Together these systems provide a unique multimodal imaging facility to study brain development in the newborn, identify those at risk of long-term brain injury and better understand how babies respond to different treatments.

To find out how this facility can help your research or to enquire about opportunities for collaboration, please contact Centre Director Professor Topun Austin. For more information on the centre and current research projects, visit https://neolabresearch.com.

What does Gut Reaction do?

For many patients, these records cover their whole IBD journey, from diagnosis to treatment, including different medications and surgeries.

Over time, these data create a detailed picture of how their IBD has developed and progressed, and this information is used to help them make treatment decisions with their doctors.

These health records form a very important source of health data. However, different kinds of this data are stored in different locations – for example, GP surgeries, pathology or radiology clinics, or pharmacies.

Another key source is the data that is collected when IBD patients take part in research. People who participate in research through the NIHR IBD BioResource (part of the NIHR BioResource) provide a biological sample (usually blood) that can be used to read their genetic information (DNA) and provide other information about them, such as their blood type and information about how their immune system is functioning.

NIHR BioResource participants also complete a health questionnaire and allow access to their health records. The biological samples and data are safely and securely stored in the sample repository in Milton Keynes, and the data at University of Cambridge.

Gut Reaction aims to develop tools to make it possible to bring these sources of data (real-world health data and research data from the BioResource) together on thousands of people with IBD, so that clinicians and scientists can access these data for research purposes without compromising privacy of individuals or the security of the data.

Tinnitus study revises protocol and patient-facing documents as result of PPI feedback

Dr Marina Salorio-Corbetto, who is studying how tinnitus affects adults who use cochlear implants and the effectiveness of sound therapy in improving tinnitus symptoms, initially asked the panel to review the participant information sheet (PIS), consent form and questionnaire for her project.

This review was carried out by panel members via email and the volunteers’ feedback on their readability, coherence and phrasing helped Dr Salorio-Corbetto – who does not suffer from hearing loss – gain more understanding of what it’s like to live with this condition.

But their feedback also showed the range of difficulties experienced by those with hearing loss – and that while doctors can scientifically predict its effects, this may not accurately reflect the day-to-day reality for people living with the condition.

Dr Salorio-Corbetto took on board many of the PPI panel members’ recommendations but it also became clear to her that her research would benefit from a tinnitus-specific PPI group, including people with varying degrees of hearing loss and with symptoms of tinnitus. Dr Salorio-Corbetto now plans to set this up to help improve the sound therapy intervention and feedback on the research as it evolves.

Amendment

Feedback from the panel also led to a research-protocol amendment, which Dr Salorio-Corbetto agrees has helped make her research more attractive to potential participants.

The testing sound therapy on participants was originally set to last for one day but panel members felt that this was too long – especially if those taking part did not live locally or had other things to do.

This was accepted and the protocol amended from 7 hours for the testing sound therapy to 4 hours.

Medicine Adherence for Patients Support (MAPS)

The researchers had devised a series of text and voice messages to remind patients to take their medication. This intervention was created to help those who forget or needed support to adhere to a routine to take their medication.

The research team were not sure if the messages were of the right tone or if the nature of delivery would be acceptable or viewed as intrusive. Their research aimed to gather views of patients on long term medication asking them to trial the system and then attend a focus group to collect their views. Ultimately they wanted to provide evidence to support this intervention for patients who forget to take their medication.

The CUH PPI Panel were involved in reviewing the Patient Information Sheets (PIS) and Consent Forms and two individuals who already take medications long term volunteered to test run the intervention and focus group discussion.

Impact

This feedback and early testing allowed the research team to make changes to the PIS and consent forms. The feedback drew out some issues around patient confidentiality and recruitment of patients through their GP. The trial of the messaging and the test run of the focus groups helped the team to modify the intervention and provide them with valuable insights as to how they might facilitate the focus group discussion.

The aim of this input was not necessarily to change the primary outcome of the research but to ensure that their approach would optimise input and feedback from the patients taking part.

The panel were very supportive of the study, having learned that non-adherence to medication potentially costs the NHS £millions in wasted prescriptions and also compromises the health of patients often leading to other more intensive treatment.

Dr Katerina Kassavou who is leading the study was very grateful of the support and feedback she received. She also presented her work at a CUH PPI panel meeting and to the PPI oversight committee gaining exposure for the research and support from patient and public representatives.

The time allowed to gather and test the intervention happened over a 4-6 week period. The research team now have an improved Patient Information Sheet; an improved intervention with modifications to the messaging service; valuable insight to improve the focus group discussions; and were open to friendly but challenging questions which have given them the opportunity to prepare for the types of question you might receive from a funding committee or ethics board.

How can we prevent frail elderly patients from losing strength following a hospital admission?

As a result, many frail people require admission to hospital because they are unable to look after themselves at home. One of the reasons frail people struggle to recover from illness might be because they lose muscle and become weaker when in hospital due to lack of activity.

The aim of this study was to investigate changes in muscle strength in frail elderly patients following a hospital admission. Peter Hartley, a physiotherapist who is leading the study, asked for support from the CUH PPI panel to help design the intervention.

With the support of PPI Coordinator they coordinated a focus group of 10 individuals from the panel. The aim of the meeting was to discuss and gain views on the overall approach of the study; how to measure changes in strength and physical ability; and the panel’s views on patients having an exercise programme in hospital.

Impact

The focus group discussion raised a number of issues around the acceptability of this type of intervention in elderly patients (over 80). Practical suggestions were made which changed the outcome measures from counting 10 repeats of a standing/sitting exercise to however many the patient could manage.

The discussion and subsequent document review allowed Peter to modify the study design and give consideration as to how to sensitively recruit patients. Again the panel could clearly see the need for this research and the support for activities to help elderly patients retain muscle strength and mobility.

Peter’s grant application was successful, and he was awarded a highly competitive Dunhill Medical Trust Research Training Fellowship award which will allow him to carry out this research over the next three years.

HOPE – ART (Health Observation & Patient Effect modelling for Abrogation of Radiotherapy Toxicity)

Amy wanted to know in particular if the panel thought there was significant patient benefit – and if the approach was acceptable. She was keen to seek the panel’s views as early as possible in the proposal process to ensure that changes and modifications could be incorporated in her study.

The term prostate cancer describes a group of cancers that arise within the male prostate gland. Around 47,000 men each year are diagnosed with prostate cancer. Both surgery and radiotherapy are considered the gold standard treatment for prostate cancer dependent the stage of the cancer. Almost 90% of those diagnosed with prostate will survive 5 years or more, while 84% will survive 10 years or more. It is therefore vital that we consider the implications of not only the short-term side effects of treatment and prognosis but also the management of long-term side effects (morbidities) and impaired quality of life, both from the patients’ perspective and health economically.

The aim of the study was to develop a predictive modelling tool that combines health observations, severity of acute radiation (during treatment) toxicity and overall dosage of radiation received to predict which men are more likely to have late radiation (6 months after treatment) toxicity side effects.

Around 7% of patients experience the late radiation side effects, some of which are as a result of damage to the organs around the prostate during the radiation treatment; and can include diarrhoea, urgency, and erectile dysfunction.

This can cause significant problems for patients and lead to further treatment in the NHS. The study hopes to be able to identify men most at risk and then be able to support them more appropriately during their treatment. Knowing who those patients are will also significantly reduce the financial burden to the NHS as treatment plans can be adjusted.

The panel provided a great deal of feedback to Amy to help her explain her study rationale, also in how she might approach patients around some of the more sensitive questions, particularly concerning erectile dysfunction. Amy attended a panel meeting and gave a very clear and informative presentation followed by a Q&A. This has also helped her to prepare for presenting her work in future to funders and other lay audiences.

If you are a member of the public…

The link below will take you to our Patient and Public Involvement pages, with information on:

• Taking part in research
• Patient Led Research Hub
• Training Opportunities
• Case studies
• Jargon-buster

We hope to see you soon!

FAQs for researchers

Don’t forget – it’s not just the PPI team who can help you; we can also draw on the skills and expertise of the CUH PPI panel, a group of more than 70 members of the public who are interested in getting involved in local research and who can get involved in PPI activities directly with your team. We can also provide advice to help you involve specific communities or patient groups and connect you with groups we know through our network.

Can the PPI team help me design a PPI strategy for my research project?

Yes, please! We are very happy to help researchers at all career stages to involve people in their research. We can provide advice on creating a PPI strategy for your project, as well as how you can describe this strategy for your research proposal. Please get in touch with Amanda or Georgina and we can discuss how to involve people in your research.

I’m working on a research proposal (or planning to)/not yet funded and need some free or low cost ways to involve the public to inform my application. Can you help?

Yes. Our PPI Team can provide advice on ways to involve people in your research that are free or very low cost. We also have a large panel of people (the CUH PPI panel) who are interested in getting involved in research and there are several ways that we can involve them that will cost you no more than a packet of biscuits.

Can the PPI team help me calculate PPI costings for my grant?

Absolutely. Please get in touch and we can discuss what your project needs and how much you should request to cover it.

Can you and/or the panel write the PPI section of my grant for me?

No. However, a member of the PPI Team will be very happy to review what you have written and it is possible to send PPI sections (or even whole applications) to be reviewed by the panel.

My funding application form asks what training I will provide my PPI members. Is this something you can help me with?

The PPI team have been working on creating training support for members of the public involved in research projects on campus. Please get in touch with us and we can discuss what we are able to offer further.

I would like to include a PPI post in my research proposal, can you advise on this?

Absolutely! The PPI team can help you write the role description for such a position, advertise the post through our networks, assist with interviewing and provide training and support to your recruited team member.

I don’t know anything about PPI! Where can I find out more?

The PPI team run several, free ‘Introduction to PPI for Researchers’ training courses on campus each year. These are currently all online. We also run courses on more specific topics, including how to run a PPI panel. You are welcome to get in touch with the PPI Team to discuss your training needs.

Can the PPI team organise/run my patient event for me?

The current pandemic means that all public-facing events are currently on hold. However when restrictions are lifted, we will again be happy to provide advice on style and format of patient events, connect you with patient groups we know, help you to publicise your event through our public networks and assist with incorporation of feedback into your research project.

If your event is local and held during business hours, and we have capacity, we may be able to help you facilitate your event. However, we are a very small team and do not have the capacity to organise, fund or run events on your behalf. If you are planning a large patient engagement event as part of your research proposal, we recommend that you cost a PPI post into your project. The PPI team can help you write the role description for such a position, advertise the post through our networks, assist with interviewing and provide training and support to your recruited team member to help them to arrange such an event.

I am currently working in health research. Can I join the panel?

In most cases, no. Patient and public involvement (PPI) in research aims to get outside/lay views on our research projects, which already undergo peer review by other researchers at various stages along the research journey, in order to benefit from the lived experiences of those who have health conditions and to understand how our research is viewed through public eyes. Researchers generally have other professional opportunities to influence research.

The panel are regularly invited to review documents for planned or ongoing research projects. As health research is competitive environment, with many groups aiming to gain funding or publish papers on similar topics, it is important that documents shared with the panel remain confidential. To make sure that researchers feel able to continue their research without fear of another group using their work without permission, we do not typically allow those working in research to join the panel. For similar reasons, we also discourage those currently employed by the pharmaceutical industry from joining. However, if you have lived experiences of a health condition or healthcare, separate from your experience as a researcher (e.g. as a patient), and wish to get involved in research in that capacity, please contact a member of the PPI team and we would be happy to discuss whether alternative arrangements can be made for your involvement.

Involving the CUH PPI Panel in my research

I need my response in less than 2 weeks. Can I still ask the panel for feedback?

Meaningful PPI takes time – both because your contributors need adequate time to reflect on the project in order to provide their feedback, but also because we value our contributors’ time and we can’t expect them to instantly provide feedback with no notice. You also need time to be able to reflect on their feedback and adjust your research in response. As such, we will not send research proposals out to the whole panel with a less than two-week deadline. However, if you need to get some feedback quickly, we will work with you where we can. If you have a short deadline, please get in touch with Georgina or Amanda who will discuss your requirements with you and see what we can organise.

Why do I need to submit background information and a lay summary if my research proposal doesn’t require one?

It is much easier for our PPI contributors to provide quality feedback to a project when they understand the context that the research is happening in – remember that all contributors (including the PPI team!) can only provide feedback about the research based on the information you have provided us. Sometimes understanding why you have chosen a particular subject and the research that has preceded it can be really helpful in better understanding the project overall. Likewise, a lay summary is essential to help the panel understand your research and helps you to practice your ability to discuss it with a lay audience.

What if the panel hates my project?

Members of the panel aim to be your ‘critical friends’ and very much want to see your research succeed. Sometimes comments might feel challenging or questioning, and the intent behind this is always to help you think about how to make your research stronger and more appropriate to the end users. If you feel that you have received lots of negative comments, please get in touch with the PPI team and we will help you work through the feedback and discuss how you can use it to improve your research.

How much does it cost to use the panel?

If your research is funded or supported by the NIHR Cambridge Biomedical Research Centre (most researchers whose research involves patients on campus), there is no cost for you to involve the panel in your research. We cover the reimbursements for panel members to attend focus groups organised by the PPI team using PPI meeting rooms. The only cost to research teams is for refreshments for panel members attending focus groups. If you wish to involve panel members in other activities as part of your research (for example, as a representative on a steering committee) then it would be up to you to discuss and cover any payments or reimbursements for those activities.

Can I use my own facilities for the focus group?

Yes, you are welcome to use your own meeting rooms for a focus group. However, if the facility you wish to use is not on campus, you will need to cover the travel reimbursements for the attendees through your research funds. Similarly, you will need to help us provide directions to the panel in our invitation.

I didn’t get my funding/ethics approval. Do I still need to feedback to the panel?

We are sorry to hear that. Yes, we would still like to be able to feedback this news to the panel and hear what you plan to do next. Grant/ethics rejections are an unfortunate reality of the research process and the panel want to hear about the outcomes of the research they support – both good and bad. The team is also very happy to discuss the PPI feedback from your application and where it could be improved, if this area was mentioned in the feedback.

Can I put panel members as co-researchers on my grant application?

Under a minority of circumstances, it may be possible to invite a panel member to be a co-researcher/co-applicant to your project. However, we will only invite panel members to do this where we feel that your project could truly benefit from a public co-applicant and where you can demonstrate that you plan to involve them to an extent that reflects that of a true co-applicant. We cannot give you the name of a panel member to add to your application for this purpose (yes, we have been asked this before!).

Is my project confidential?

Yes. In order to become a member of the CUH PPI panel, panel members must sign an agreement not to discuss or share any of the projects that they are involved in. The PPI Team discuss this requirement with all new members and explain why privacy and confidentiality are important. Similarly, the PPI team will not discuss the specifics of your project with anyone without your consent. Occasionally we meet other researchers or research support staff that we think could benefit from talking with you – however, we will not introduce them without first gaining your permission.

General questions about PPI

My project doesn’t use human participants. Do I still need PPI?

Need? Maybe not, if your funding body doesn’t require it. Could it still benefit from involvement? Almost certainly! If your research will ultimately influence the treatment of patients (as we hope it will!) or has used samples or data that came from patients (even in another study) then you should be involving patients and the public in the research. All research can benefit from involving the public, even if just to write a lay summary and assist with the dissemination plan. The PPI team are happy to help you find ways to involve people in your research, however obscure, and you will be surprised at the valuable perspectives you gain from the process.

Some of the suggestions made by contributors are contradictory/impossible to implement. What should I do?

It is true that asking lots of people for their opinions will give rise to… lots of opinions – the classic one being a combination of too long/too short/just right replies! Ultimately, you are the final decision-maker and can choose to implement the suggestions and feedback that are right for your project. Where this happens, it can help to explain to contributors why you took the decision that you did (for example, you couldn’t make your document longer, because there is a word limit). You can also take a lot of the information on board in other ways – for example the feedback may make you aware of useful information that you can include in your patient documents that answers a particular question or refutes a common misconception. The PPI team are very happy to help you review your feedback and help you use it to improve your research.

COVID-19 studies recruiting at CUH

Alongside the excellent care our staff are delivering, we are using our tremendous research capabilities to better understand COVID-19 and its successful management, including development of innovative approaches to testing and treatment.

National studies that we are supporting in Cambridge Hospitals include: PRIEST (Pandemic Respiratory Infection Emergency System Triage) to optimise the triage of people using the emergency care system; RECOVERY (Randomised Evaluation of COvid-19 thERapY), a trial of potential therapies that can be adapted to introduce new treatment arms as potential therapies emerge; and REMAP-CAP (Randomised, Embedded, Multifactorial, Adaptive Platform trial), a trial designed to evaluate a number of treatment options simultaneously and efficiently in critically ill patients.

We have also developed a new research resource in the NIHR COVID-19 BioResource, which allows all patients admitted to Cambridge hospitals to participate in research studies by providing biological samples and health information. The NIHR COVID-19 BioResource will be instrumental in understanding why the virus affects people in such different ways and identifying new treatments.

Our SAMBA (simple amplification-based assay) point of care test is helping us rapidly find out whether patients have COVID-19 and ensure that they receive the right treatment in the right ward of the hospital.

We would like to thank all of the clinical and research staff who have made these remarkable achievements possible in such a short period of time, as well as all of the patients who have participated in our studies and made such a valuable contribution to improving care and treatment for COVID-19.

First Addenbrooke’s Patient in National COVID-19 Trial

The Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, will test several medications that are safely used for other conditions, and that have shown promise in other countries.

The opportunity to join this trial will be offered to adults who are hospitalised with COVID-19 at Addenbrooke’s, and other participating NHS hospitals across the country, and who do not have health conditions that would interact with the trial drugs. There are 3 drugs being tested in the first stages of the trial, including hydroxychloroquine, which is similar to a drug used to treat malaria and some rheumatic diseases. However, the trial follows an ‘adaptive’ design, which means that if further drugs show promise, they can be added to the treatments being tested.

The trial results will be regularly reviewed so that any treatments that are found to be effective can be made available to all patients.

Participation in this national trial is part of Cambridge’s wider contribution to COVID-19 research. Local principal investigator Dr Martin Knolle said “this is an example of Cambridge researchers, as part of a national effort, pulling together to deliver potentially life-saving treatments in record time in the most difficult of circumstances. I am very proud of our team and research community for this response.”

Cambridge trial targets immune response to treat COVID-19 patients

The TACTIC-R trial will target patients as they are admitted to hospital, and test whether drugs that suppress the immune system can prevent the body from ‘over-reacting’ to infection and destroy healthy tissues as well as virus-infected ones, leading to severe COVID-19 disease.

For the majority of people who have COVID-19, the infection causes only mild symptoms including a fever and cough. However, around 15% of patients develop severe disease, which includes serious damage to the lungs and multiple organ failure. This lung and organ damage appears to be mostly caused by the body’s own immune system responding to the presence of infected cells. Researchers hope that preventing the immune ‘over-reaction’ using drugs that stop or ‘suppress’ the immune response will stop patients developing the severest form of COVID-19, preventing the need for intensive care.

TACTIC will initially test two drugs – Ravulizumab and Baricitinib – that used to treat other conditions caused by an overactive immune system.

Ravulizumab is usually used to treat autoimmune conditions where the body destroys red blood cells.

Baricitinib is used to treat people with rheumatoid arthritis.

Both these drugs have been carefully selected by a consortium of doctors and scientists with expertise in treating immune-mediated diseases, and are thought to have a high chance of reducing the immune ‘over-reactions’ seen in very sick patients with COVID-19.

This is an abridged version of the news story that was first published on our website on 16 May 2020.

Who has reviewed this trial?

This trial has been reviewed and given favourable opinion by North West – Greater Manchester South Research Ethics Committee.

The Medicines and Healthcare Products Regulatory Agency (MHRA) who are responsible for regulating medicines in the UK have also reviewed this trial.