This study will compare two different ways, to help people with their recovery from a broken shoulder. Patients with this injury are usually referred for physiotherapy appointments for advice on how to get their arm and shoulder working again

In this study, patients will be asked to follow one of two rehabilitation programmes. They will either be offered:  Outpatient physiotherapy appointments to be shown what exercises to do or advice and information about a self-directed exercise programme that can be done at home. Advice will be given by a health professional in the hospital clinic, and you will also be given a high-quality workbook to help guide your recovery. 

PI: Rhian Witham 

Start Date: Jan 2025

End Date: Dec 2026

Local Ref: 5639

Evaluation of safety and efficacy of a resorbable collagan IMplant in treatment of High Grade PArtical thiCkness Tear; A prosepctive, mulitcentre, randomized, control trial.

Patients who are 18 years and over, with a partial rotator cuff injury who’s symptoms persist following 3-6 months of conservative treatment are eligible for this study.

Impact study compares two types of surgery:

The rotator cuff is a group of muscles and their tendons that act to stabilize (hold in place) the shoulder. Torn rotator cuff tendons are common injuries that result in shoulder weakness and pain. These injuries can be treated with medications, injections, and physical therapy. However, when symptoms continue despite these treatments, surgery is often recommended to repair the injured tendon. An alternative to standard surgical procedures for repairing torn rotator cuff tendons involves applying a protective layer of collagen over the injured tendons to aid in healing and stop disease progression. Collagen is the most commonly found protein in the body and is present in the skin, bones, tendons and ligaments. The collagen is extracted from bovine Achilles tendons (from cows).  

The purpose of this study is to find out if the marketed REGENETEN™ Bioinductive Implant is better than standard repair techniques for surgically treating partial-thickness rotator cuff tears. Smith+Nephew is the company paying for the study and REGENETEN is one of their products.

Project Details:

Principal investigator: Iain Packham

Start date: March 2023

End date: June 2026

Local ref: 5311

Peri-Op Iron and Erythropoietin (EPO) Intervention Study 

Anaemia after major emergency surgery in older people with hip fractures is common and is associated with increased mortality, longer length of hospital stay and poorer quality of health. The POP-I trial aims to recruit patients 60 and over, who are anaemic in the postoperative period following either hip fractures. Participants who give their consent will be assigned randomly into one of three study groups: Usual care, Iron Infusion, or iron infusion and an injection that will stimulate red blood cell production.

PI: Katherine Walsh 

Start Date: Nov 2024

End Date: July 2025

Local Ref: 5535

This study will explore if additional exercise advice for people aged 50 and over who have broken their wrist helps with recovery.

After breaking their wrist, people are often provided with basic advice by the person who is treating them about how to get their wrist working again. WISE would like to find out if more detailed exercise advice given by a Physiotherapist will improve how quickly and how well they recover from a broken wrist.

Project Details:

PI: Mr Alasdair Bott

Start Date: Mar 2024

End Date: Feb 2025

Local Ref: 5452

This study aims to find out the best treatment for patients 16 years and over with repeated dislocations of their kneecap (patella). The study is comparing personalised knee therapy, delivered by a Physiotherapist, to surgical stabilisation for improving patient function following repeated dislocation.

Project Details:

PI: Mr Damian Clark

Start Date: Dec 2023

End Date: Aug 2025

Local Ref: 5440

This study compares surgery to sling immobilisation in the management of adults with a displaced fracture of the distal clavicle (Collarbone) in patients over the age of 18 years old with 21 days of injury. 

When the outer end of the collarbone has broken, parts of the bone may separate and not line up. This can rupture the ligaments connecting the collarbone to the shoulder blade. Doctors commonly treat this type of injury that have had with: A sling, to help support the shoulder while the bone heals naturally; or surgery that uses metal work to try the separated bone while they knit together naturally.  Both treatments work but we do not know which one works the best. The aim of this study is to find this out. 

Project Details:

PI: Iain Packham 

Start Date: December 2023

End Date: 30 June 2025

Local Ref: 5405

Following surgery for a hip fracture (broken hip) hospitals aim to help patients out of bed within 48 hours of surgery. Patients should also receive a minimum of 2 hours of rehabilitation per week. Patients who receive more than this seem to recover quicker and return home sooner. This study aims to find out if increasing the level of ward-based mobilisation activities for patients following hip fractures allows them to return home sooner.

Project Details:

PI: Kirsty Derrick

Start Date: August 2024

End Date: August 2025

Local Ref: 5285

Distal Radius Acute Fracture 3: Cast verus Splint; a randomised non-inferiority trial comparing clinical and cost-effectiveness of a standard cast versus removable splint in Adults with a distal fracture tat does not require Manipulation.

When a person breaks their wrist, the treatment usually involves a support for the injured wrist. This support provides pain relief. It also protects the fracture (the break) whilst it heals.

In most hospitals in the UK, people with a broken wrist are given a plaster cast. After 4 to 6 weeks, they go back to hospital to have the cast taken off.

The results of a recent research study show that a removable wrist splint might provide the wrist with the same amount of support as a cast.

The benefit of this is that you can take it off yourself at home, so you don’t need to have it removed at a hospital. This could be more convenient for you. Providing people with a splint instead of a cast might also save money for the NHS.

At the moment, doctors, physiotherapists and other healthcare professionals are not completely sure if having a splint gives the same level of pain relief and support as a cast.

In this study, we will directly compare people receiving a cast with people receiving a splint for treating broken wrists. We want to find out if levels of pain and the ability to do everyday tasks are similar between the two groups. We will also have a look at the cost of both treatment options to the NHS, and society as a whole.

Project Details:

Principal investigators: Alasdair Bott and Fran Verey

Start date: 03/2023

End date: 12/2024

Local ref: 5350

Lidocaine Intravenous Trial

A broken hip is a very serious injury that requires surgery to repair or replace the broken bone followed by a period of recovery in hospital. Around a quarter of patients who have a hip fracture have an episode of ‘delirium’ following surgery. Delirium is a condition where the patient loses awareness of themselves and the environment, and has difficulty thinking clearly. Inflammation, caused by the hip fracture and by the surgery to repair the hip, is thought to be the root cause of delirium. 
This study investigates the use of a drug called ‘lidocaine’ to see if it reduces the risk of delirium during surgery for a hip fracture.

Project Details:

Principal Investigator: Dr Paddy Morgan

Planned end date: June 2025

Local Ref: 5120

Randomised Controlled Trial of Specialist Vocational Rehabilitation and Psychological Support to Enhance Return to Work after Trauma.

Getting back to work, voluntary work or education after an injury can be difficult. Many patients with serious injuries can have difficulties returning to work because of the physical and psychologists’ effects of problems. This can lead to financial and other problems. Overall, being in work is better for health than unemployment or prolonged sick leave. We therefore want to find out the best of healing patients make a successful return voluntary work or education. The Rowtate study aims to test the return-to-work programme support versus the standard trauma care at people returning to work after traumatic injury.

Project Details:

Principal Investigator: Edd Carlton

Planned end date: May 2025

Local Ref: 4927

PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2.

This study is investigating the best way to treat patients aged 65 and over who have broken the top end of the upper arm bone (humerus) near the shoulder where the bone is broken into more than two parts.

There are currently three commonly used treatment options for fractures of this kind, which are two types of joint replacement surgery or structured non-surgical treatment. It is currently not known what the ‘best’ treatment is so this study is comparing non-surgical treatment and two types of joint replacement; ‘hemiarthroplasty’ which involves replacing only the broken ‘ball’ of the joint (top end of the arm bone), or ‘Reverse Shoulder Arthroplasty’ which replaces both the ball and socket, but replaces the ball with a socket and the socket with a ball (hence ‘reverse’).

Project Details:
Principal Investigator: Mr Mark Crowther
Planned End Date: June 2025
Local Ref: 4202

Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions (FRUITI).

Patients who sustain hip fractures that involve minimal displacement of the bone fragments may be treated surgically with either replacement of the hip joint of fixation of the fragments. The study is randomly allocating patients with these types of fracture to either type of surgery. Patients will be monitored up to 12 months post surgery.

Project Details:

Principal Investigator: Mr Tim Chesser
Planned End Date: 31/01/2029
Local Ref: 4695

This study aims to assess the performance and function of the newly introduced INFINITY(tm) with ADAPTIS(tm) and EVERLAST(tm) technology Total Ankle System for total ankle replacement or arthroplasty

Project Details:
Principle Investigator: Steven Hepple
Planned End Date: 31/05/2025
Local Ref: 5570

The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing. A pragmatic multicentre randomised controlled Trial with blinding.

Total knee replacement (TKR) is commonly used for treating severe arthritis, with over 100,000 performed annually in the UK. During TKR, surgeons can resurface the patella (replace the under surface of the kneecap with a plastic prosthesis) or leave the native patella to articulate with the femoral implant. Resurfacing the patella is initially more expensive (longer theatre time, higher implant cost, risk of additional post-operative complications), but in the long-term it can reduce the risk of on-going pain which can result in further surgery to resurface the patella. NICE recommends always resurfacing the patella rather than never doing so. NICE did not find sufficient evidence on selective resurfacing (intraoperative decision based on the state of the patellar surface and the patients' symptoms) to make a recommendation on that strategy, but did recommend specific research was conducted on this question. If effective, selective resurfacing could result in optimal individualised patient care. This study evaluates the clinical and cost-effectiveness of elective primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Project Details:

Chief Investigator: Ashley Blom

Principal Investigator: Sven Putnis

Planned End Date: 31/03/2026

Local Ref: 4999

Hip Implant Prosthesis Programme for the Younger total hip replacement patient.

Over 100,000 hip replacements are performed each year in the UK. Around 90% of patients report good pain relief and mobility after surgery, and most implants last 25 years or more.

Primary hip replacement involves replacing a damaged hip joint with an artificial implant that has two main parts. One part goes into the leg bone and ends in a ball which fits into a socket or cup attached to the pelvis, making a ball-and-socket joint. Implants can be fixed to bone with cement (cemented), without cement (uncemented), or partially cemented (hybrid). Cost ranges from £500 for some cemented to £2,000 for some uncemented implants.

When an implant fails, for example due to loosening or wear, it has to be re-done. Revision is a major operation, typically costing the NHS over £10,000. Cemented hip implants are safe, inexpensive, have a long track-record, and offer the best value-for-money for men aged over 75 and women aged over 65 years. There is no high-quality evidence to suggest more expensive uncemented or hybrid implants are any better than cemented implants for younger patients. Yet three quarters of NHS patients aged under 70 years receive uncemented or hybrid implants.

This Programme of research aims to find out which hip implants are best for patients under 70 years of age.

Project Details:

Chief Investigator: Elsa Marques

Principal Investigator: Mike Whitehouse

Planned End Date: 01/07/2031

Local Ref: 5258, 5259

This study aims to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement or arthroplasty in patients with severe osteoarthritis of the ankle.

Project Details:
Principal Investigator: Steven Hepple

Start Date: 02/09/24
Planned End Date: 31/05/2025
Local Ref: 5570

This is a commercial study reviewing progress of patients who have undergone total hip replacement surgery using the Furlong short stem implant. The potential benefit for using a short stem implant is that it aids early mobilisations and preserves the femoral bone should further surgery be required.

Project Details:
Principal Investigator: William Poole
Planned End Date: 30/09/2027
Local Ref: 3275

A commercial study involving review of patients treated with an INFINITY Total Ankle Replacement. The study is collecting clinical and patient reported outcomes up to 10 years following surgery.

Project Details:

Principal Investigator: Mr Steve Hepple
Planned End Date: 31/12/2029
Local Ref: 4168

This study aims to compare two different plates currently used in knee realignment surgery (high tibial osteotomy). The purpose of the metal plates is to maintain the correct realignment achieved at surgery whilst the bone heals. The two plates, TomoFix and ActivMotion are both used in current practice and comply safety regulations.

Once the knee correction has healed (approx. 12 months) the plate can be left in. Some patients may however experience discomfort that related to the plate and benefit from plate removal ,  about a year after their initial operation. The ActivMotion plate design is a smaller than the Tomofix and it is therefore potentially less likely to cause discomfort . It is anticipated that second operations for plate removal will be less frequent than for the Tomofix plate.

In this study we would like to compare the number of plates that need removal following surgery, assess pain levels in patients in the first two years following surgery and compare the amount of pain relief used in the immediate post-operative recovery period.

Participants will be asked to complete a questionnaire before they have their operation and twelve months after the operation to assess their pain and function. This information will be used to compare the outcome of the plates.

Project Details:
Principal Investigator: Mr James Murray
Planned End Date: 31/03/2024
Local Ref: 3810

This study is a prospective, post-market, global, multi-center, non-controlled, observational clinical evaluation of the commercially available Persona® Partial knee implant. The primary objective of the study is to obtain survivorship data and assess clinical performance (outcomes) using outcome measurement tools (e.g. patient questionnaires), radiographic assessments and adverse event data.

In total, there will be 30 global sites in the US and Europe. In the UK, the multi-centre study is being conducted at four sites in England with a maximum of 40 patients at each centre. Male and female individuals aged 18 years and over, with a confirmed diagnosis of osteoarthritis and who qualify for unicompartmental (partial) knee surgery will be potentially eligible to take part. Each Investigator will offer study participation to each consecutive eligible patient who satisfies the Inclusion/Exclusion criteria for partial knee arthroplasty using the commercially available Partial Persona Knee.

Following completion of the informed consent process, participants will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Patients will then be asked to attend post-operative follow-up clinic visits at 3 months, 1 year, 2 year, 5 year and 10 year. At these follow-up visits, clinical and radiographic evaluations will be conducted.

Project Details:

Principal Investigator: Mr Andrew Porteous
Planned End Date: 31/12/2028
Local Ref: 3905

Hip replacements are a very common operation for people with painful arthritis. However, sometimes these hip replacements need to be done again because of pain and loosening.  We think that similar things may lead to loss of bone density (thinning of the bones) and loosening of joint replacements.  Because of this there is concern that loss of bone density may increase the need for further surgery to correct the loose joint replacement.

The study aims to see if there are differences in bone density and other factors that may explain why some people need their hip replacements done again (revised) and some do not.

Project Details:

Principal Investigator: Dr Emma Clark
Planned end date: 31/12/2025
Local Ref: 2503

 Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI): a multi-centre, pragmatic, parallel group, superiority randomised controlled trial. 

Patient aged 60 years or over with painful OA of the shoulder and an intact rotator cuff presenting to secondary care and through shared making, having completed non-surgical treatments, proceeding to shoulder replacement. In shoulder replacement surgery, doctors remove the damaged parts of the shoulder and replace them with plastic or metal parts. 

The RAPSODI-UK study compares two types of shoulder replacement: the Total shoulder  replacement, and the Reverse Shoulder replacement.  These are the two types of shoulder replacement that NHS doctors use most often for patients with arthritis who need a shoulder replacement.  

They both help to reduce pain, and maintain or improve movement. However, doctors genuinely don’t know yet which one works best. 

 Project Details:

Principal Investigator: Mr Mark Crowther  

Planned end date: 30/08/2024 

Local Ref: 5267 

This recipe makes a fruit cake with a lighter sponge and all the flavours of Christmas. It doesn’t need to mature like a traditional Christmas fruit cake.

Serves 16.

Ingredients

• 10oz/250g glace cherries, quartered
• 10oz/250g mixed peel
• 8 oz/200g tinned prunes, drained and chopped
• 5 eggs
• 2 dessert spoons of brandy/rum
• ½ teaspoon of almond essence (optional)
• 10oz/250g plain flour
• 1 teaspoon baking powder
• 7oz/175g soft brown sugar
• 10oz/250g unsalted butter, softened
• ½ teaspoon ground cinnamon
• 1 teaspoon ground mixed spice

Method

1. Place the cherries, mixed peel and prunes in a large bowl, add the brandy/rum and leave to soak overnight.
2. Grease a 7” (18cm) round cake tin, and double line with greaseproof paper. Preheat the oven to 140oC/120oC fan assisted.
3. Beat the butter, sugar, flour, eggs and spices in a large mixing bowl until well combined. Fold in the pre-soaked fruit and pour into the prepared cake tin.
4. Place a double layer of greaseproof paper loosely on top of the cake, and bake in the oven for 3 ½ to 4 hours. Remove greaseproof paper 15 minutes towards the end of cooking.
5. Leave to cool in the tin, and once cooled decorate with the icing of your choice. Store in an airtight container.

Ingredients

• 120g icing sugar
• 1tsp ground cinnamon
• 1tsp (5ml) water
• 2tsp (10ml) juice of an orange

Method

Sieve the icing sugar together with 1 tsp cinnamon, and mix with the water and juice of an orange. The icing should be thick enough to coat the back of the spoon. If it is too runny add a little extra sieved icing sugar, or if it is too thick then add a little more water.

Ingredients

• 8oz/200g plain flour
• 1 apple, grated
• 1 carrot, grated
• 4oz/100g sugar
• 4oz/100g mixed peel
• 3oz/75g glacé cherries
• 4oz/100g white breadcrumbs
• 3oz/75g tinned plums, drained and chopped
• 4oz/100g tinned prunes, drained and chopped
• 2 teaspoons mixed spice
• 1 egg
• 6 fl oz/150 ml milk
• 2 fl oz/50 ml brandy
• Caramel colouring
• 2 teaspoons lemon juice

Method

1. Mix together the flour, apple, carrot, sugar, mixed peel, cherries, breadcrumbs, plums, prunes and mixed spice.
2. Add the milk, brandy, egg, a little caramel colouring and lemon juice. Mix well.
3. Line a pudding bowl with a floured pudding cloth and place the mixture in the centre. Tie securely.
4. Put into a large pan half filled with hot water and boil the pudding for 4 hours. Cool and keep in the fridge.
5. Steam again for 4 hours before serving hot.

Foods to choose from

Turkey, chicken, duck, goose, beef, lamb, pork or fish.

Foods to choose from

Dishes made with tofu, Quorn, lentils, pumpkin,or squash. Cheese or brie and cranberry pastry parcels.

Foods high in potassium

Dishes made with nuts, courgette, mushrooms, spinach, sweet potato.

Foods to choose from

Boil potatoes first to make roast or mashed potatoes.

Foods high in potassium

Potatoes which have not been boiled.

2-3 portions

1 portion = 2-3 tablespoons

Foods to choose from

Boil vegetables. Choose those lower in potassium such as carrots, red cabbage and cauliflower. Limit Brussel
sprouts to 6.

Foods high in potassium

Vegetables such as mushrooms, parsnips, spinach, vegetable/tomato soup.

Foods to choose from

Yorkshire pudding, apple sauce, cranberry sauce, homemade bread sauce, mint sauce and horseradish.

Foods to choose from

Fruit pie or crumble (except for rhubarb, blackcurrant or apricot), artic roll, gateaux, ice cream, sorbet, pavlova,
profiteroles or trifle. Brandy/rum butter or double cream with puddings.

Foods high in potassium

Try to limit to 1 portion of either Christmas pudding or Christmas cake or 1 mince pie or 1 slice of Yule log.

Foods to choose from

Clementines, satsumas, apple, raspberries, tinned fruit.

Foods high in potassium

Fruits such as apricots, bananas, dried fruit and fruit juices.

Foods to choose from

Plain breadsticks, unsalted popcorn, corn, maize or wheat snacks (choose those without potassium chloride), pickled onions, cheese and biscuits. Carrot or cucumber sticks with cottage/cream cheese or sour cream or mayonnaise dips. Cranberries. Chestnuts (5)

Foods high in potassium

Potato crisps, Twiglets, guacamole, salsa, nuts and dried fruit.

Foods to choose from

Chicken or fish goujons, mini sausages, blinis or crispbreads with pate or salmon and cream cheese, prawns, arancini balls, mini quiches or vol au vents.

Foods to choose from

Sponge cake, gateaux, cream cakes, jam tarts, jam or cream swiss roll, brandy snaps, gingerbread or shortbread.

Foods high in potassium

Stollen, biscuits, cake containing dried fruit, nuts.

Foods to choose from

Jelly sweets, mint creams, marshmallows and Turkish delight.

Foods high in potassium

Liquorice, hot chocolate. Limit chocolate to 4 pieces / squares or 2 chocolate coated biscuits.

Foods to choose from

Liqueurs, port, sherry, spirits. 1 small beer/lager or 1 glass of wine/mulled wine or champagne.

Foods high in potassium

Cider and strong ales. Drinks/cocktails with fruit juice.

A multi-centre cohort study comparing health outcome data from Holter monitoring to 14 day Zio monitoring in people where ambulatory ECG monitoring is required.

In 2020 an independent evaluation of the Zio service as part of the Digital Health Technologies programme at NICE was conducted. From the available clinical and economic evidence, the evaluation was concluded that further evidence is needed to estimate the resource use associated with Zio compared with standard care, particularly the number of outpatient visits and repeat testing needed. Additionally, it recommended further evidence is needed of outpatient visits and repeat testing consequences such as anticoagulant uptake and other changes to treatment related to the results from monitoring. Therefore, this study aims to address these uncertainties and identify whether the Zio service could be used in the health and social care system in England. This existing standard of care cohort using Holter monitor (cohort 1) will be collected from 6-month retrospective pre-covid date, and, for the Zio service cohort (cohort 2), data will be collected retrospectively over a 6-month period. Each cohort will include two separate populations recruited from cardiology clinics and stroke/TIA clinics. The main objective of this study is to analyse quantitative date collected from participating sites and complementary qualitative data on Zio utilisation from questionnaires, with the purpose of answering the following research questions:

1. Does the Zio service reduce the number of outpatient visits and repeat tests needed compared with standard of care (Holter monitor)?
2. Is there a difference in resource utilisation in cohort 1 receiving standard of care compared with cohort 2 receiving Zio service?
3. What are the cost-consequences of using Zio service in cardiology and stroke/TIA populations compared to current standard of care?
4. Is there a difference in the time to treatment decision for anticoagulants or other clinical intervention for AF or other clinically significant arrhythmia?
5. Are there any factors identified during this study at the participating centres that should be considered if Zio monitor compared to a population receiving Holter monitor?
6. Is there a shift in the spectrum of patients using Zio monitor compared to a population receiving Holter monitor?
7. What is the patient and clinician experience with the Zio service in comparison with the standard of care (Holter monitor)?
8. Is there greater utilisation of the Zio patch in hard-to-reach populations living in rural areas who may have difficulty travelling to clinics?

Chief Investigator – Dr Anna Barnes

Principal Investigator – Dr Philip Clatworthy

Cavernomas A Randomised Effectiveness (CARE) pilot trial, to address the effectiveness of active treatment (with neurosurgery or stereotactic radiosurgery) versus conservative management in people with symptomatic brain cavernoma.

A cavernoma is a cluster of blood vessels that form blood-filled ‘caverns’ in the brain that look like a raspberry. Cavernomas can bleed into the brain and cause a stroke. Cavernomas can also cause a seizure or epilepsy. About 160 people in the UK each year are diagnosed with a cavernoma that has caused symptoms. Stroke and seizure may lead to disability, handicap and occasionally death. In standard practice in the UK, most people with cavernomas have medical management (which may involve scans, drugs, or rehabilitation) to manage these symptoms. About one fifth also have ‘surgical management’ with either brain surgery to remove a cavernoma or stereotactic radiosurgery to stabilise it with radiation. Surgical management can cause death, disability, and handicap.

The pros and cons of medical management versus medical and surgical management are finely balanced. The most reliable way of finding out which management is best to do a randomised trial, in which suitable patients are allocated to medical management or medical and surgical management at random. This has never been done with cavernomas, and this was the top priority identified by a Priority Setting Partnership for cavernoma. The NIHR wants research to be done to find out whether enough patients can be found for a randomised trial comparing ‘medical management’ with ‘medical and surgical management’ of symptomatic cavernomas. We need to know this because cavernomas are rare and we do not know whether patients and doctors will take part.

In three years, we will:

1. Create a network of specialists to do this study. We will include the UK and Ireland patient support organisations for people with cavernoma and doctors representing the relevant specialities at all the major hospitals specialising in decisions about cavernoma treatment in the UK and Ireland.
2. Invite newly diagnosed patients to join a pilot phase of a randomised controlled trial. Of 190 people diagnosed with brain cavernoma in 18 months, we estimate that 60 of them will enrol in the randomised trial. We will study why some patients take part in the randomised trial and others don’t. We will use this information to change the methods of the trial if recruitment to the randomised trial goes slowly.
3. Estimate whether enough patients can be found for a full-scale randomised trial to be done to find out whether medical management or medical and surgical management of symptomatic brain cavernomas is best.

Chief Investigator – Professor Rustam Al-Shahi Salman

Principal Investigator – Mr Mario Tao

Key study findings:

• Majority of patients hospitalised with COVID-19 have not fully recovered after 5 months
• Those who experience more persistent symptoms tend to be middle-aged, white, female, with at least two ‘co-morbidities’, such as diabetes, lung or heart disease
• Cognitive impairment, also referred to as ‘brain fog’, occurs as a predominant symptom in a sub-set of patients who tend to be older and male
• A biological marker associated with inflammation, C-Reactive Protein (CRP), is elevated in all but the most mild of post-hospital cases

The majority of survivors who left hospital following COVID-19 did not fully recover five months after discharge and continued to experience negative impacts on their physical and mental health, as well as ability to work, according to results released by the PHOSP-COVID study today. Furthermore, one in five of the participant population reached the threshold for a new disability.

The UK-wide study, which is led by the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre – a partnership between Leicester’s Hospitals, the University of Leicester and Loughborough University - and jointly funded by the NIHR and UK Research and Innovation, analysed 1077 patients who were discharged from hospital between March and November 2020 following an episode of COVID-19.

Researchers found that each participant had an average of nine persistent symptoms. The ten most common symptoms reported were: muscle pain, fatigue, physical slowing down, impaired sleep quality, joint pain or swelling, limb weakness, breathlessness, pain, short-term memory loss, and slowed thinking.

Patients were also assessed for mental health. The study reports that over 25 per cent of participants had clinically significant symptoms of anxiety and depression and 12 per cent had symptoms of post-traumatic stress disorder (PTSD) at their 5-month follow-up.

Of the 67.5 per cent of participants who were working before COVID, 17.8 per cent were no longer working, and nearly 20 per cent experienced a health-related change in their occupational status.

Professor Chris Brightling, a professor of respiratory medicine at the University of Leicester and the chief investigator for the PHOSP-COVID study, said:

“While the profile of patients being admitted to hospital with COVID-19 is disproportionately male and from an ethnic minority background, our study finds that those who have the most severe prolonged symptoms tend to be white women aged approximately 40 to 60 who have at least two long term health conditions, such as asthma or diabetes.”

The researchers were able to the classify types of recovery into four different groups or ‘clusters’ based on the participants’ mental and physical health impairments.

One cluster group in particular showed impaired cognitive function, or what has colloquially been called ‘brain fog’. Patients in this group tended to be older and male. Cognitive impairment was striking even when taking education levels into account, suggesting a different underlying mechanism compared to other symptoms.

Dr Rachael Evans, an associate professor at the University of Leicester and respiratory consultant at Leicester’s Hospitals, said:

“Our results show a large burden of symptoms, mental and physical health problems and evidence of organ damage five months after discharge with COVID-19. It is also clear that those who required mechanical ventilation and were admitted to intensive care take longer to recover. However, much of the wide variety of persistent problems was not explained by the severity of the acute illness - the latter largely driven by acute lung injury - indicating other, possibly more systemic, underlying mechanisms"

The pre-print, title, which is yet to be peer-reviewed, is now available to view on Med Archives.