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14th April 2020
Furthermore, several oral medical devices are marketed for treatment of conditions in children and both parents and health professional incorrectly assume that relevant efficacy studies have been undertaken prelaunch.
Recently, researchers examined the patient leaflet content of three medical devices: two for diarrhoea and one for gastro-oesophageal reflux. All three were promoted to the public and health professionals with a perceived image as “paediatric drugs”.
The study revealed that efficacy data for all three were either limited or absent for the specific indications. Furthermore, there was no mention of potential interactions yet for one product, the main ingredient was known to adsorb many other drugs and to inhibit cytochrome P450.
The authors of the study concluded that the regulations for medical devices need revision, especially for products intended for oral use in children.
NG166 discusses the importance of communicating with patients, their families and carers to support their mental wellbeing during the COVID-19 pandemic. NG166 advises signposting to charities such as the British Thoracic Society, Asthma UK and the British Lung Foundation, all of which have provided advice on COVID-19 to help alleviate any anxieties or concerns that patients might have about the virus. NG166 also stresses to clinicians to reinforce with patients that severe asthma has been defined by the European Respiratory Society as a condition that “requires high dose inhaled corticosteroids plus a second controller(and/or systemic corticosteroids) to prevent it from becoming uncontrolled.” In addition, as noted by NG166, some patients with severe asthma will have received a government letter advising them on shielding. Staff should strongly advise patients or their carers (including those with suspected or confirmed COVID-19) to continue with the regular medicines and to follow personal asthma plans which should be current.
NG166 suggests minimising both face-to-face contact for consultations and non-essential follow-up appointments and that telephone or video consultations should be used instead or making contact with patients via email or text messaging. NG166 advises on the use of alternative routes for patients to obtain medicines such as pharmacy deliveries, postal services, use of NHS volunteers or even drive-through pick-up points for medicines.
In cases where face-to-face consultations are required, NG166 directs staff to contact all patients by telephone on the day of their appointment to screen for COVID-19 symptoms. In addition, NG166 suggests patients attend appointments alone if possible but with no more than one family member or carer to reduce the risk of contracting the virus. Clinic staff are advised to minimise the time patients spend in the waiting area through careful scheduling of appointments, discouraging arriving early and asking them to remain in their cars until they receive a text message that the clinic staff are ready to see them.
Where patients are known or suspected of being infected with COVID-19, NG166 recommends that UK government guidance on infection prevention and control is adhered to since this provides advice on the use of personal protective equipment, patient transfers, transport and options for outpatient settings.
Investigations
NG166 suggests that bronchoscopy and most pulmonary functions tests should only be performed on urgent cases and if these tests have a direct impact on patient care due to the potential of spreading COVID-19. NG166 directs interested readers to NHS England’s recent clinical guide for managing respiratory patients during the COVID-19 pandemic.
Treatment
Biological therapies
NG166 advises that patients or their carers should continue with biological therapy as there is no evidence that treatment suppresses immunity in asthmatics. In cases where a patient normally attends a hospital to obtain biological treatment, NG166 suggests that clinical teams consider if the patient could be trained to self-administer or treated at a community clinic or even at home. If possible, routine monitoring of biological treatment should be performed remotely.
Patients starting biological therapy
For new patients, NG166 recommends that clinical staff assess the balance of risks and benefits of treatment, taking into account any relevant service modifications. The guideline suggests that treatment with a biological in a new patient can be started even if staff are unable to assess adherence to regular treatment in the normal way and if a multidisciplinary team discussion is not possible. In such instances, NG166 recommends that two senior clinicians in the commissioned service or delegated by the commissioned service can make the decision to start treatment.
When initiating biological treatment in a new patient, NG166 instructs staff to ensure that the patient Blueteq is completed and that continuation and annual review forms are finished at a future date. Patients should also be added to the registry after gaining consent. However, NG166 advises that addition of patient data to the registry can be deferred provided arrangements are made to complete it at a future date.
NG166 suggests that arrangements are in place to enable patient self-administration or through homecare for subsequent doses thereby reducing the need to attend hospital. However, in the current pandemic, NG166 also notes that some homecare services are not accepting new referrals and that responsibility to organise delivery therefore remains with the hospital department.
Corticosteroids
The advice in NG166 is that patients continue to use inhaled corticosteroids as stopping treatment risks an asthma exacerbation. In addition, patients should be informed that there is no evidence that inhaled corticosteroids increase the risk of getting COVID-19. Similar advice applies to oral corticosteroids but NG166 adds that stopping oral agents can be harmful. Patients are also advised follow their personalised asthma plan in the case of an exacerbation.
Equipment
NG166 advises that clinical staff inform patients or their carers to continue with nebulisers because the aerosol comes from fluid in the device and will not carry COVID-19 particles from the patient. NG166 directs staff to the government infection and control guidance for further information.
Modification to usual care
In light of the pandemic, clinic staff are requested to modify usual care at an organisational level and in particular, to ensure social distancing is observed in the patient waiting areas. Another practical suggestion in NG166 is to only prescribe sufficient quantities of treatment for 30 days as prescribing greater amounts puts the supply chain at risk.
NG166 is available online and interested readers should check this version for further updates.
8th April 2020
The guideline covers all stages of pregnancy from antenatal care, obstetric triage, intrapartum through to postpartum management and neonatal care.1 It also includes a section of the medical treatment of pregnant women who test positive for COVID-19.
The authors consider their recommendations as suggestions, recognising that these may need to be fine-tuned in different centres. Furthermore, they recognise that as the knowledge-base of COVID-19 changes rapidly, their guidance should be considered in light of other relevant guidance from other organisations such as the World Health Organization.
The pertinence of the guideline is that because of the physiological changes associated with pregnancy, women are predisposed to viral respiratory infections and are known to be more likely to develop severe illness after such infections. This has been highlighted in other respiratory outcomes such as the H1N1 (swine flu) outbreak in 2009, in which 5% of all H1NI-related deaths occurred in pregnant women. Fortunately and to date, the limited information that is available, has demonstrated that pregnant women diagnosed with COVID-19 survive pregnancy without any major complications.
Antenatal care
The first point of the guideline is the recommendation to reduce the number of clinic visits for low-risk women and the suggestion that staff use telephone or video calls instead. Pregnant women should self-check their blood pressure at home and provided with advice on when it would be appropriate to seek medical advice. During clinic appointment, all women should be screened for COVID-19 symptoms and any relevant exposure and attend alone if possible. When screening reveals that the woman potentially has COVID-19, the appointment should be deferred for 14 days unless there are urgent maternal or foetal reasons. The guidance also suggests that where screening identifies a likely infection and the appointment is deemed necessary, the woman should wear a mask and her appointment is considered as a priority to minimise her time at the clinic. An antenatal outpatient care algorithm is provided in the guideline as a useful resource for healthcare staff.
Obstetrical triage
When a woman attends obstetric triage or the emergency department for either obstetric or respiratory symptoms, the guideline advocates the same screening procedure as for antenatal care. As with the antenatal care guidance, a positive screened woman needs to wear a mask and be assessed in isolation. Both symptoms and vital signs and comorbidities should be assessed and COVID-19 testing considered. In the case of mild symptoms, the patient can discharged and asked to monitor symptoms, seeking further advice if symptoms worsen.
In cases where the patient has moderate disease or comorbidities and other risk factors for severe COVID-19 infection, it is advised that a more detailed assessment is undertaken.
Intrapartum management: suspected or confirmed cases
The guideline mentions that COVID-19 infection is not an indication for delivery unless there is a need to improve maternal oxygen. Suspected or confirmed cases should have their delivery in an isolated negative pressure room and the number of staff present kept to a minimum. It is advised that birthing partners are not permitted to attend. The delivery needs to be assessed on an individual basis and as with the other sections, a useful intrapartum algorithm is provided.
Postpartum and neonatal care: suspected or confirmed cases
In cases of suspected or confirmed cases, umbilical cord clamping should be performed promptly and the neonate transferred to the resuscitation area for assessment. However, the guideline recognises that there is insufficient evidence on whether delayed clamping increases the risk of infection to the new-born. Staff should continue to use PPE during the postpartum period unless or until the mother tests negative for COVID-19. The guideline states that there is a lack of evidence on the possible transmission via breastfeeding but recommends separation with attempts to express breast milk if the mother is severely ill. Again an algorithm is provided to help staff manage postpartum care.
Psychological interventions
The guideline recognises how pregnant women are at an increased risk of anxiety and depression, especially where they are considered as a suspected or even confirmed COVID-19 infection. Staff are advised to pay particular attention to the woman’s mental health and make an assessment of her sleep patterns and potential sources of anxiety and depression and even suicidal ideation.
Treating suspected/probably infected cases
Suspected, probable and confirmed cases of COVID-19 infection should be managed in isolation facilities with protective equipment. Where there is a definitive diagnosis, women should be treated in a negative pressure isolation room. However, the guidance believes that pregnant infected women with mild symptoms can remain at home provided her condition can be suitably monitored. If a woman needs to be transferred to hospital, staff are advised to wear appropriate personal protective equipment (PPE) and maintain a 2m distance from any individuals without PPE.
It is advised that fluid and electrolyte balance are maintained and symptomatic antipyretic treatment is offered. Women’s vital signs should be monitored e.g. oxygen saturation, full blood count and renal, liver function and coagulation testing regularly evaluated. In addition, foetal surveillance should be undertaken including cardiotocography (CTG) for heart rate monitoring (weeks 23–28).
Infected patients
Mild disease
This should be as for managing suspected cases above, that is, maintaining fluid and electrolyte balance and surveillance. Although recognising that there are currently no proven effective anti-viral treatments for COVID-19, the guideline suggests that if these are considered a decision should be made after consultation with a virologist. It is also recommended that women are monitored for bacterial infection (for example, blood cultures, midstream or catheterised specimen urine microscopy and culture) and that the foetus is monitored with CTG as in suspected cases above.
More severe cases
Women with more severe disease such as pneumonia should be managed in line with the American Thoracic Society guidelines for community-acquired pneumonia. The guideline notes how severe pneumonia is associated with a high maternal and perinatal mortality rate and therefore requires aggressive therapy including both supportive measures with hydration and oxygen therapy. Treatment should include appropriate antibacterial and anti-viral agents following discussion with microbiologists.
Finally, the guideline states that there is currently no evidence of vertical mother-to-baby transmission for those becoming infected in late pregnancy although this position might be modified in light of any new evidence.
Reference
Results of the study are published in Neurogastroenterology & Motility.
In the study, 53 women and 15 men with irritable bowel syndrome participated in an eight-week mindfulness-based stress reduction class.
Most participants experienced significant improvements from pre-treatment to three months follow up regarding gastrointestinal symptoms, quality of life, and anxiety related to gastrointestinal symptoms.
Although increases in three of the five measured facets of mindfulness were found, increases in the ability to stay in the present moment and act with awareness seemed especially important.
“This study shows that people with irritable bowel syndrome can have significant improvements in their symptoms and quality of life without medication or diet change, just by participating in a mindfulness-based stress reduction class,” said senior author Kirsten Tillisch, MD, of the University of California, Los Angeles.
“Further, it implicates a specific aspect of mindfulness as particularly important: acting with awareness. It appears that by improving this moment to moment awareness in their daily actions, people with irritable bowel syndrome feel better, possibly because this mindful activity in the present moment keeps the brain from going back to old fears or worries.”
A study published in Alimentary Pharmacology & Therapeutics compared the health of pregnant and non-pregnant women with IBD. The study included 2058 Korean women with IBD who became pregnant between 2007 and 2016 and 20,580 women of similar age who did not have IBD.
Overall, women with IBD did well during pregnancy; however, they had higher rates of Caesarean section and intrauterine growth retardation (low birth weight babies) than women without IBD. Of the patients who had Crohn’s disease, those with quiescent-to-mild disease did as well as women without IBD; however, women with Crohn’s disease that was not mild-to-moderate had a higher rate of miscarriage and almost a threefold higher rate of intrauterine growth retardation than women without IBD.
“Previous studies could be easily biased since considerable numbers of pregnant women with IBD with quiescent or mild activity were likely to be excluded. We overcame this limitation by using a nationwide database covering 98% of the 52 million citizens of an entire nation,” said corresponding author Bo-In Lee, MD, PhD, of The Catholic University of Korea.
The commentary outlined the specific pharmacy service needs required during the pandemic: drafting professional service guidance to pharmacists; establishing emergency drug formularies based on treatment guidelines; working with drug companies and distributors to ensure adequate supplies, storage and transport of formulary medicines; providing event-drive pharmaceutical care; establishing remote pharmacy services; educating the public on infection prevention and disease management and finally involvement on clinical research to screen, evaluate and develop anti-viral medicines.
How each of these needs was achieved is described with examples. For instance, one hospital Pharmacy created an online and remote service using the Chinese social media app WeChat®, offering patients free consultations, education and the opportunity to purchase medicines online and thus reducing unnecessary hospital visits.
Though describing the efforts of pharmacists in China, the article offers an important insight into how pharmacy services across the globe could potentially evolve in response to the current crisis.
As of 7 April 2020, Italy has had the highest number of deaths (16,525) in Europe with 132,547 people testing positive for the virus, which is slightly less than Spain (135,032).
Italy has one of the most well-developed healthcare systems in the world yet the system seemed to have been unprepared to manage the sheer volume of cases produced by COVID-19. This was despite the country declaring a state of national emergency on 31 January 2020, limiting public gatherings that impacted on schools, conferences and sports events. Due to the number of cases, there was an international shortage of personal protection equipment leading to infection among frontline doctors and nurses who became infected and thus quarantined.
This article provides a comprehensive overview of the Italian COVID-19 outbreak, which the authors hope will be of value to other healthcare systems. It offers information on the clinical presentations, protocols and the strategic planning required to deal with the increased workload generated by the pandemic.
7th April 2020
The short course of treatment involves higher-intensity radiation rather than five weeks of radiotherapy coupled with chemotherapy. Surgery, which normally happens one to two weeks after radiotherapy, can be safely delayed by up to 12 weeks, say the expert panel.
This approach, based on the latest research evidence, will maintain the best chance of successfully treating the disease while at the same time reducing the side effects of treatment and the risks of COVID-19 infection.
People with bowel cancer are more susceptible to severe complications from COVID-19 because their immune system is weakened. Shorter-course radiotherapy avoids the need for chemotherapy, which further suppresses the immune system. It also means significantly fewer hospital appointments, allowing patients to maintain social distancing rules.
David Sebag-Montefiore, Professor of Clinical Oncology at the University of Leeds and Honorary Clinical Oncologist with the Leeds Teaching Hospitals NHS Trust, who led the expert panel, said: “The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients. Our recommendations were published 20 days after our first meeting.
“This process normally takes many months, if not years.”
Writing in the journal Radiotherapy and Oncology, the panel, made up of cancer experts from across Europe, say it is also possible that hospitals may struggle to offer the current treatment approaches as COVID-19 impacts on hospital staffing levels.
The expert panel’s recommendations can be found here: https://www.thegreenjournal.com/article/S0167-8140(20)30173-0/pdf
The 15-strong panel comprised researchers who led the defining studies. Their research shows that surgery can be safely delayed by 12 weeks. The chances of successful treatment are maintained and post-operative side effects are reduced. This allows surgery to be scheduled after the peak of the pandemic.
The recommendation to use shorter-course radiotherapy follows a major study, funded by the UK Medical Research Council and led by Professor Sebag-Montefiore, which demonstrated the benefit of the one-week course of radiotherapy.
Professor Sebag-Montefiore added: “Our guidelines will result in a very substantial change in treatment across the globe. During the COVID-19 pandemic, our patients will benefit from the use of an effective, shorter and safer radiotherapy treatment.”
This clinical trial, led by Professor Danny McAuley and Professor Cecilia O’Kane, both researchers from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s, is investigating the use of allogenic mesenchymal stromal cells (MSCs) in patients with a complication known as acute respiratory distress syndrome (ARDS) caused by COVID-19.
In the most critically unwell patients with COVID-19, many develop a complication known as ARDS. In ARDS the lungs become inflamed and leaky so they fill with fluid. This causes respiratory failure and patients may require admission to intensive care and a ventilator machine to support their breathing.
A recent statement from the four UK Chief Medical Officers outlined the importance of clinical trials amidst the COVID-19 crisis. Professor Cecilia O’Kane said: “It is only through clinical trials we will be able to determine if new treatments are effective and safe in critically ill patients.”
The trial involves the use of MSCs to treat the injury to the lung caused by COVID 19. MSCs are a novel treatment that have been shown in experimental models to reduce inflammation, fight infection and improve the repair of injured tissue.
Patients in this trial, which is known as REALIST COVID 19, will be treated with a purified population of MSCs derived from umbilical cord tissue called ORBCEL-C. The ORBCEL-C therapy has been developed by scientists at Orbsen Therapeutics in Galway, Ireland. The ORBCEL-C therapeutic is manufactured under licence by the UK NHS Blood and Transplant Service for the REALIST COVID-19 trial.
The trial is being introduced as part of an existing programme of research investigating the use of MSCs in patients with ARDS. The first patient has now been recruited with plans to recruit at least 60 patients throughout the COVID-19 pandemic at multiple sites across the UK including Belfast, Birmingham and London.
Professor Ian Young, Clinical Professor at the Centre for Public Health, Queen’s University Belfast, Director of HSC R&D and Chief Scientific Advisor at the Department of Health, said: “The Health and Social Care Research & Development Division has been working with researchers across HSC to address the global problem of Coronavirus. We have contributed £230K for this vital research which will provide important evidence regarding a potential new treatment for respiratory failure, a leading cause of mortality in COVID-19. We will continue to support health research and encourage people to participate in research trials and other studies so patients can get the best possible treatment to help tackle the spread of COVID-19.”
The trial has been identified by the National Institute for Health Research (NIHR) as a national urgent public health study. It is one of a number of COVID-19 studies that have been given urgent public health research status by the Chief Medical Officer/ Deputy Chief Medical Officer for England. The study is funded by the Health and Social Care Research & Development Division and the Wellcome Trust, sponsored by the Belfast Health and Social Care Trust and supported by the NI Clinical Trials Unit, the NIHR Clinical Research Network and the Northern Ireland Clinical Research Network.
Orbsen CSO Steve Elliman noted: “While there are over 100 vaccines and therapies in development targeting the SARS-CoV-2 infection – at present there are no disease modifying therapies approved for ARDS. We’re delighted the REALIST trial was approved and listed by NIHR as an Urgent Public Health Research Study so we can continue assess the safety of the ORBCEL-C therapy in patients with ARDS.”
Sir Professor Alimuddin Zumla of University College London said: “This is an exciting and important trial which targets rectifying the underlying causes of lung damage and has great potential of saving many lives from COVID-19. The team should be congratulated for their leadership of host-directed therapies, a concept which has not yet been explored to its full potential.”
Professor Danny McAuley is also part of an international network of researchers who are taking forward trials of umbilical cord-derived Mesenchymal stromal cells for the treatment of COVID-19: UK: (UCL- Sir Professor Azumla); Portugal (Champualimud Foundation – Professor Markus Maurer; Italy (INMI-Professor Giuseppe Ippolito) and China (Fifth Medical Center- Professor Fu-Sheng Wang.)
One group of staff at a heightened risk include anaesthetists, who are in close proximity to patients. In light of these risks, two Chinese Anaesthesia Societies have come together and produced recommendations to support healthcare to optimise patient care while at the same time protecting both staff and patients.
The authors comment on how the recommendations are only relevant to practice within China and due to differences in other healthcare systems throughout the world, may not be generalisable. However, the general advice provided would appear pertinent to all healthcare systems and is now common practice in other countries.
For example, use of personal protective equipment by staff and that a patient’s temperature is recorded before entering the consulting room and if above 37.3 degrees C, that the patient should be taken to special clinics for fever disorders and reported to the infection control officer.
Other recommendations related to hand hygiene and cleaning and disinfection are also now practised in other countries. Other advice to cancel non-urgent procedures for infected patients and post-operative isolation of infected patients and use of negative pressure wards serve to illustrate just how seriously the potential for infection was managed by the Chinese.
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