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31st March 2020
The work was led by NYU Grossman School of Medicine and the Courant Institute of Mathematical Sciences at New York University, in partnership with Wenzhou Central Hospital and Cangnan People’s Hospital, both in Wenzhou, China.
“While work remains to further validate our model, it holds promise as another tool to predict the patients most vulnerable to the virus, but only in support of physicians’ hard-won clinical experience in treating viral infections,” says corresponding study author Megan Coffee, MD, PhD, clinical assistant professor in the Division of Infectious Disease & Immunology within the Department of Medicine at NYU Grossman School of Medicine.
Published online in the journal Computers, Materials & Continua, the study also revealed the best indicators of future severity, and found that they were not as expected.
“Our goal was to design and deploy a decision-support tool using AI capabilities – mostly predictive analytics – to flag future clinical coronavirus severity,” says co-author Anasse Bari, PhD, a clinical assistant professor in Computer Science at the Courant institute. “We hope that the tool, when fully developed, will be useful to physicians as they assess which moderately ill patients really need beds, and who can safely go home, with hospital resources stretched thin.”
Surprise predictors
For the study, demographic, laboratory, and radiological findings were collected from 53 patients as each tested positive in January 2020 for the SARS-CoV2 virus at the two Chinese hospitals. Symptoms were typically mild to begin with, including cough, fever, and stomach upset. In a minority of patients, however, severe symptoms developed with a week, including pneumonia.
The goal of the new study was to determine whether AI techniques could help to accurately predict which patients with the virus would go on to develop acute respiratory distress syndrome or ARDS, the fluid build-up in the lungs that can be fatal in the elderly.
For the new study, the researchers designed computer models that make decisions based on the data fed into them, with programs getting “smarter” the more data they consider. Specifically, the current study used decision trees that track series of decisions between options, and that model the potential consequences of choices at each step in a pathway.
The researchers were surprised to find that characteristics considered to be hallmarks of COVID-19, like certain patterns seen in lung images (for example, ground glass opacities), fever, and strong immune responses, were not useful in predicting which of the many patients with initial, mild symptoms would go to develop severe lung disease. Neither were age and gender helpful in predicting serious disease, although past studies had found men over 60 to be at higher risk.
Instead, the new AI tool found that changes in three features – levels of the liver enzyme alanine aminotransferase (ALT), reported myalgia, and haemoglobin levels – were most accurately predictive of subsequent, severe disease. Together with other factors, the team reported being able to predict risk of ARDS with up to 80% accuracy.
ALT levels – which rise dramatically as diseases like hepatitis damage the liver – were only a bit higher in patients with COVID-19, researchers say, but still featured prominently in prediction of severity. In addition, deep muscle aches (myalgia) were also more commonplace, and have been linked by past research to higher general inflammation in the body.
Lastly, higher levels of haemoglobin were also linked to later respiratory distress. Could this explained by other factors, like unreported smoking of tobacco, which has long been linked to increased hemoglobin levels? Of the 33 patients at Wenzhou Central Hospital interviewed on smoking status, the two who reported having smoked, also reported that they had quit.
Limitations of the study, say the authors, included the relatively small data set and the limited clinical severity of disease in the population studied. The latter may be due in part to an as yet unexplained dearth of elderly patients admitted into the hospitals during the study period. The average patient age was 43.
The study, led by researchers at King’s College London, also found other types of drugs, such as TNF blockers and JAK inhibitors safe to use.
89 existing studies on other coronavirus strains such as MERS and SARS, as well as the limited literature on COVID-19, were analysed to find out if certain pain medications, steroids, and other drugs used in people already suffering from diseases should be avoided if they catch COVID-19.
Some patients, for example those with cancer, are already given immunosuppressive drugs or immunostimulant drugs. If these patients then catch COVID-19, doctors need to know what medication to stop.
Dr Mieke Van Hemelrijck, a cancer epidemiologist and an author on the paper, said “This pandemic has led to challenging decision-making about the treatment of COVID-19 patients who were already critically unwell. In parallel, doctors across multiple specialties are making clinical decisions about the appropriate continuation of treatments for patients with chronic illnesses requiring immune suppressive medication.”
The article has been published in ecancermedicalscience, an open access oncology journal, and is authored by researchers from King’s College London and Guy’s and St. Thomas NHS Foundation Trust, London.
There had been some speculation that non-steroidal anti-inflammatory drugs such as ibuprofen might make things worse for some COVID-19 patients, but the researchers did not find evidence to support this statement.
Other types of drugs such as TNF blockers and JAK inhibitors, used to treat arthritis or other forms of inflammation, were also found to be safe to use. Anti-interleukin-6 agents are being investigated for helping to fight COVID-19, although there is no conclusive proof yet.
The researchers found that low amounts of prednisolone or tacrolimus therapy may be helpful in treating COVID-19. Co- author, Dr Sophie Papa, a medical oncologist and immunologist said: “Current evidence suggests that low dose prednisolone and tacrolimus therapy may have beneficial impact on the course of coronavirus infections. However further investigation is needed.”
COVID-19 presents a rapidly changing situation where different pressures, including changes to children and young people’s social lives, daily routines, and access to education as well as challenges associated with families spending extended periods at home, will arise for children, young people and their families over time.
Professor Cathy Creswell, Departments of Psychiatry and Experimental Psychology, University of Oxford, said, ‘Research has provided valuable information about how parents and carers can support their children’s mental health in general. However, at this point, we know very little about what might be most effective in the current context of COVID-19. We hope to have more than 10,000 parents and carers across the UK complete the new online survey. Their responses will help us really understand how families are coping and what support could make all the difference to children, young people and their families at this time.’
This survey, called Co-SPACE (COVID-19 Supporting Parents, Adolescents, and Children in Epidemics), aims to track children and young people’s mental health throughout the COVID-19 crisis. Survey results will help researchers identify what protects children and young people from deteriorating mental health, over time, and at particular stress points, and how this may vary according to child and family characteristics. It also aims to identify what advice, support and help parents would find most useful. Parents/carers will be invited to complete an online longitudinal weekly questionnaire for a month, then fortnightly for a month, and then monthly until schools reopen.
The first survey will take about half an hour, and subsequent surveys about 15-20 minutes. Parents/carers will be asked to answer questions about family life and relationships, overall health and wellbeing, parenting, psychological symptoms and how they and their child are coping during the Covid-19 pandemic. Regular summaries of key findings will be made available via the UKRI www.emergingminds.org.uk research network website throughout the study and will be shared directly with partner organisations in health and education services and the community and voluntary sector, to inform the development of effective support for children, young people and families.
This research is supported by the NIHR Oxford Health Biomedical Research Centre, the Oxford and Thames Valley NIHR Applied Research Consortium and the UKRI Emerging Minds Network Plus.
Authors of an analysis published in The Lancet Infectious Diseases warn that without intervention the number of people needing hospital treatment is likely to overwhelm even the most advanced healthcare systems worldwide, though caution that as the pandemic unfolds, it is possible that outcomes could improve and it will be important to revise estimates in this study.
The new analysis also finds that the estimated proportion of deaths from both diagnosed cases and from milder, unconfirmed cases is strongly influenced by age. The estimates are slightly lower than others that have been made for the virus, but are still much higher than for previous pandemics such as 2009 pandemic influenza H1N1, which was estimated to be fatal in around 0.02% of cases. The new estimates are based on an analysis of 70,117 laboratory-confirmed and clinically-diagnosed cases in mainland China, combined with 689 positive cases among people evacuated from Wuhan on repatriation flights.
“This study provides critical estimates on the proportion of people requiring hospitalisation which, when applied to the UK population, enabled us to get a handle on how many people might need to access NHS services,” says Professor Neil Ferguson from Imperial College London, UK. “As the UK epidemic unfolds, more data are becoming available, and at the moment the proportion of people in each age group most likely to require hospitalisation, and most likely to die from infection, are consistent with the estimates in this study.”
Key findings
The authors warn that as 50% to 80% of the global population could be infected with COVID-19, the number of people needing hospital treatment is likely to overwhelm even the most advanced healthcare systems worldwide. However, they caution that it is possible that outcomes could improve, in which case it will be important to revise the estimates in this study.
“Our estimates can be applied to any country to inform decisions around the best containment policies for COVID-19,” says Professor Azra Ghani from Imperial College London, UK. “There might be outlying cases that get a lot of media attention, but our analysis very clearly shows that at aged 50 and over, hospitalisation is much more likely than in those under 50, and a greater proportion of cases are likely to be fatal.”
Previous estimates of deaths from confirmed cases of COVID-19 have ranged from 2% to 8%, while deaths from overall infections have been estimated at 0.2% to 1.6%. Also, estimates for the proportion of deaths in the oldest age group, the over-80s, have been estimated to be between 8% to 36%. However, these past estimates had not adjusted for the fact that only people with more severe symptoms are likely to be tested, or people in quarantine following repatriation to other countries, so they did not reflect the true number of cases across populations. No previous studies have estimated the proportion of infections that will require hospitalisation.
For the current analysis, a team of international researchers used 3665 cases from mainland China to estimate the proportion of cases likely to be severe enough to require hospitalisation. To estimate the average time between a person displaying symptoms and dying, they analysed 24 deaths in Hubei Province. The average recovery time was estimated using data from 2010 international cases, of whom 169 people recovered. Death rates from confirmed cases were estimated using data on 44,672 cases in mainland China. To estimate death rates relevant to the wider population, data from 689 people repatriated from Wuhan to other countries and 3711 people quarantined on board the cruise liner Diamond Princess were used.
For all the estimates, the researchers assumed that people of all ages are equally likely to become infected, which is consistent with previous studies on respiratory infections.
The analysis found the greatest number of severe cases, requiring hospitalisation, in people in their 50s (222 out of 790 cases), but once the researchers had adjusted for the fact that many milder cases will have gone undiagnosed, the hospitalisation rate is 8.2%, compared with an estimated 18.4% in the most at risk group, the over 80s (51 out of 76 cases before adjustment). 154 out of 743 people in their 40s had severe symptoms, whereas 133 out of 263 people in their 70s had severe symptoms, but the adjusted hospitalisation rates were again even wider apart than the bare numbers suggest: 4.3% for 40 to 49-year-olds compared with 16.6% for 70 to 79-year-olds. Of those in their 60s, 201 out of 560 cases were severe, whereas the adjusted hospitalisation rate was 11.8%.
The hospitalisation rates were lower for younger age groups: 3.4% of people in their 30s are likely to be hospitalised (while the unadjusted number of severe cases was 124 out of 733 cases), whereas for people in their 20s the rate is likely to be 1.0% (49 out of 437 cases before adjustment). There was only one severe case out of 50 for those aged 10 to 19 and the hospitalisation rate is estimated at 0.04%, whereas none of the 13 cases analysed in the under-10s were severe.
The average time between the first recorded symptoms and death from COVID-19 was estimated to be 17.8 days. The authors note that as the data are from early in the epidemic, more people might die following a longer time lag. Recovering from the disease is estimated to take slightly longer, with patients being discharged from hospital after an average of 22.6 days.
Most people will recover, even from severe symptoms. Death rates from confirmed cases were estimated at 1.38% across all age groups (1,023 out of 44,672 cases in mainland China, with unreported severe cases likely to add to the total, requiring the ratio to be adjusted), but the estimates rise rapidly with age. For example, there were no deaths out of 416 confirmed cases in the under 10-year olds, whereas 13.4% of people aged 80 or above were estimated to die (208 out of 1408 cases before adjustment).
The proportion of all people infected who die from the disease – most of whom will display only mild to moderate symptoms – is estimated to be slightly lower, at 0.66%. Again, the risk of death is much higher in older age groups. For example, 0.031% of people in their 20s are estimated to die, compared with 7.8% of the over-80s.
The authors note that they are unable to adjust for the effect on prognosis of underlying health conditions until individual-level data become available. However, underlying conditions are likely to be correlated with age. Their existence will also vary geographically, particularly between low-income and high-income regions and countries.
27th March 2020
COVID-19 rapid guideline: critical care
The guideline on critical care says that all patients on admission to hospital, irrespective of COVID-19 status, should continue to be assessed for frailty using a recognised frailty score (for example, the Clinical Frailty Scale [CFS]).
These guidelines have been developed to maximise patient safety whilst making the best use of NHS resources and protecting staff from infection. The guideline has been developed using the interim process and methods for developing rapid guidelines on COVID-19 and recommendations are based on evidence and expert opinion.
It also says the risks and benefits and likely outcomes should be discussed with patients, carers or advocates and families using decision support tools (where available) so that they can make informed decisions about their treatment wherever possible.
For patients with confirmed COVID-19, the guideline says decisions about admission to critical care should be made on the basis of medical benefit, taking into account the likelihood that the person will recover to an outcome that is acceptable to them and within a period of time consistent with the diagnosis.
COVID-19 rapid guideline: delivery of systemic anticancer treatments
The rapid guideline on the delivery of systemic anticancer treatments says that where decisions need to be made about prioritising patients for treatment, these need to take into account the level of immunosuppression associated with individual treatments and cancer types, and any other patient-specific risk factors. They should also balance the risk from cancer not being treated optimally versus the risk of becoming seriously ill if they contract COVID-19 because of immunosuppression.
Where changes need to be made to usual care because of system pressures, the guideline says consideration should be given to delivering treatment in different and less immunosuppressive regimens, different locations or via another route of administration.
COVID-19 rapid guideline: dialysis service delivery
The guideline on dialysis says that patients with suspected COVID-19 should be assessed to see whether dialysis could be delayed until their COVID-19 status is known. It also recommends that that outpatient transport services should get patients to their dialysis as scheduled to avoid their condition deteriorating, It should also be ensured that appropriate transport services are available by finding out what current transport providers are prepared to provide, and whether there are alternative providers if the current providers will not transport patients infected with COVID-19.
Further guidelines will be announced in due course but are likely to include: symptom management; patients receiving radiotherapy; and patients with rheumatoid arthritis. NICE will publish new guidelines each week until the full set has been completed, based on the priorities for patients and the NHS.
The guidelines are being produced in collaboration with NHS England/Improvement and a cross-specialty clinical group, supported by the specialist societies and Royal Colleges. NICE will make the guidelines accessible on its website so that health systems around the world can see the approach the UK is taking.
26th March 2020
It has been recognised for many years that low levels of medicine adherence results in poorer disease outcomes for patients. In 2003 the World Health Organization estimated that around 50% of patients with chronic illness do not take their medication as prescribed.1 Non-adherence has major cost implications and a recent estimate for the UK suggests that could be in excess of £930 million per annum.2 Various strategies have been employed to increase medicine adherence including intense education, counselling, motivational interviewing etc and a Cochrane review in 2014 concluded that “current methods of improving adherence for chronic health problems are mostly complex and not very effective”.2
Recent years have seen an accelerated increase in the use of digital technology and in particular, use of smartphones, that is, a mobile phone capable of performing many of the functions of a computer. For instance, in 2015, it was estimated that 64% of the American population owned a mobile phone and Ofcom report in 2018, noted how 78% of adults in the UK personally use a smartphone.4 Furthermore, advances in technologies permit the use of software extensions such as applications (or “apps”) that can be used on smartphones and one area is in which these apps can be used is to monitor patient’s health. In fact, a 2017 study estimated that there were approximately 325,00 mobile health apps (mHealth) available.5 These mHealth apps can be utilised to support self-management in chronic conditions to improve health outcomes by allowing patients to measure, monitor and manage their condition. An additional use of mHealth apps is to target medicine adherence and a recent review identified 704 such apps.6 Many of these apps use behaviour change techniques (BCT), that is, where a strategy is deployed to help an individual change their behaviour to promote better health such as goal setting. As an example, the use of smartphone apps to ensure that individuals achieve their 10,000 steps/day is based on a BCT. By self-monitoring (the BCT) their actual steps, an individual becomes aware of the targeted behaviour (that is, to achieve 10,000 steps) and thus increases their activity accordingly to reach that goal. Older adults are often prescribed multiple medicines and therefore likely to achieve the greatest benefit from a medicine adherence app. While the Ofcom report mentioned earlier, noted that the highest uptake of smartphones, at 95%, was for those aged between 16 and 24, there has also been an increased use of smartphones in those aged over 55 which is currently around 55%.
So is it possible that medicine adherence smartphone apps could benefit these older adults? This question was the subject of a systematic review published in the January 2020 issue of BMJ Open.7 The authors searched for studies between 1990 and November 2018 and limited their search to randomised trials in which the intervention was delivered through a smartphone, tablet computer or personal digital assistant, to help, support or advise about medication adherence. Included studies did not restrict by age and also were required to have a comparator group which received either usual care, a control condition that did not include the app or a control app which did not include any BCTs. They defined the primary outcome measure as the pooled effect size of changes in medication adherence.
In total, nine randomised trials with 1159 patients were included in the final analysis. The mean age of participants was 56.7 years and health conditions included cardiovascular disease, depression, Parkinson’s disease, psoriasis and multimorbidity (that is, where patients simply took a lot of medicines for a range of illnesses). The analysis found that use of the apps led to an increased self-reported adherence, with an odds ratio of 2.12 (95% CI, 1.64 to 2.75).
Although this result was significant, the study had several limitations. For example, six of the nine were based on self-reporting and thus subject to selective recall and social desirability bias, in other words, where participants told researchers what they thought they wanted them to hear. Furthermore, a significant result was only obtained in five of the studies. When the authors restricted their analysis to these five studies that used a recognised adherence scale (in this case the Morisky scale), the result was still significant but the odds ratio was lower (1.83). The sample size in studies also varied and ranged from 28 to 412 and the longest follow-up period was 16 weeks.
This was the first systematic analysis of the effectiveness of medication adherence apps and concluded that such apps are potentially beneficial. Nevertheless, there are still several unanswered questions including which particular app to recommend to patients or what is the most appropriate tool to measure adherence.
Unfortunately, because adherence is a long-term problem any future studies of smartphone apps need to focus on the optimal frequency of use of the app to ensure the minimum level of adherence necessary to achieve positive health-related outcomes for those struggling to take their medicines.
25th March 2020
An international collaboration led by the University of Birmingham sets out nine essential recommendations that should be implemented as a priority across all hospitals world-wide in the fight against surgical site infection (SSI).
SSI is the most common complication following abdominal surgery, affecting 9% of patients in high-income countries and 17% of patients in low- and middle-income countries (LMICs) – causing patients to experience pain and delays return to normal activities such as work.
At least 4·2 million people worldwide die within 30 days of surgery each year, and half of these deaths occur in LMICs. This number of postoperative deaths accounts for 7·7% of all deaths globally, making it the third greatest contributor to deaths, after ischaemic heart disease and stroke.
More people die within 30 days of surgery annually than from all causes related to HIV, malaria, and tuberculosis combined (2·97 million deaths). It is estimated that failure to improve surgical care will cost the world economy $12.3 trillion in lost GDP by 2030.
Additional SSI-related health costs can cause financial hardship, particularly for the most vulnerable patients in LMICs. SSI is associated with a three-fold increase in the risk of death after surgery. Treatment of SSI is increasingly challenging due to the rise of antibiotic resistance, which occurs in up to 46% of LMIC patients. This places a strong focus on preventing SSI from occurring in the first place.
Published in the British Journal of Surgery, the new Global Surgery Guideline for the Prevention of Surgical Site Infection will support surgeons in putting into practice key interventions that are proven to reduce the SSI risk.
Expert surgeons representing 14 countries across Africa, Europe, Latin America, and South Asia identified nine evidence-based interventions which can be feasibly implemented worldwide at low cost.
Mr. Aneel Bhangu, Consultant Surgeon and Senior Lecturer at the NIHR Global Health Research Unit on Global Surgery at the University of Birmingham commented: “We’ve estimated that around 20 million patients develop surgical site infections worldwide each year following abdominal surgery, including 14.7 million LMIC patients.
“The Global Surgery Guideline for the Prevention of Surgical Site Infection has identified practical steps that all hospitals should urgently take to both reduce avoidable infections and the spread of antimicrobial resistance.”
Dr. Adewale Adisa, Senior Lecturer in Surgery at the Obafemi Awolowo University in Ile-Ife, Nigeria and co-lead author commented: “High rates of SSI and antimicrobial resistance are a real worry for surgeons, particularly in LMICs. Although guidelines for prevention of SSI have previously been published, they were developed in high income countries with little thought for the specific needs of LMIC patients.
“Many of their recommendations were impractical for resource-limited hospitals, and few LMIC surgeons put them in to practice. This is the first guideline to have been led by LMIC surgeons and I believe our recommendations can be implemented immediately to benefit all patients across the world.”
The recommendations encourage medical professionals to boost patient safety by:
In addition, a further three ‘desirable’ recommendations are made in the guideline. It is recognised that worldwide some hospitals may lack the necessary resources to immediately implement these interventions, in which case they should plan strategies to introduce these interventions in the future.
23rd March 2020
The study was published online in Science Immunology.
Lead investigator Theresa Lu, MD, PhD, senior scientist in the Autoimmunity and Inflammation Program at the HSS Research Institute, and colleagues launched the study to gain a better understanding of how the immune system works.
Dr. Lu’s study focused on the lymphoid tissues, which house immune cells and are sites of immune cell activation. Lymphoid tissues, which include the tonsils, spleen and lymph nodes, contain structural elements, such as fibroblasts and blood vessels. These structural elements were thought to mainly provide an infrastructure for the immune cells, but recent advances in the field have shown that they actively shape immune cell responses, and multiple populations of fibroblasts have different functions, according to Dr. Lu.
“We found that one fibroblast population expressed a molecule called CCL2 in the area of antibody-secreting immune cells, called plasma cells. We focused on the CCL2-expressing fibroblasts to see if they regulate plasma cell function,” she explained. “We found that CCL2 limits the magnitude of plasma cell responses by acting on an intermediary cell to reduce plasma cell survival. This was surprising in some ways, as CCL2 can also promote inflammation, and yet we are finding a role in limiting immune responses. This underscores the multiple functions that any molecule can have in different contexts.“
The findings have implications for better understanding autoimmune diseases, according to Dr Lu. Plasma cells in autoimmune diseases generate autoantibodies that then deposit and cause inflammation in organs such as the kidneys and skin. “By understanding that plasma cells can be controlled by this subset of fibroblasts, we can study these fibroblasts to see if they are perhaps not working properly in autoimmune and inflammatory diseases. We can then search for a way correct the malfunction, so they are less likely to cause disease,” she notes.
“As the immune system is so central to how well our bodies function and often acts in similar ways in a number of different settings, what we are learning about manipulating fibroblasts can also help the biomedical community better understand how to treat related processes, such as healing after a musculoskeletal injury, fighting cancer and fighting infections,” she adds. “For example, medications used in adults and children with different forms of autoimmune inflammatory arthritis or lupus are being examined in the setting of coronavirus infections. We all learn from each other.”
The research recommends the scans be introduced into routine clinical practice.
A medical imaging technique known as PSMA PET/CT that provides detailed body scans while detecting levels of a molecule associated with prostate cancer could help doctors better tailor treatments for their patients, by determining the extent of disease spread at the time of diagnosis, a randomised controlled trial involving 300 patients in Australia published in The Lancet journal has found.
The approach combines two imaging technologies – positron emission tomography (PET) and computed tomography (CT) – and is almost one third more accurate than standard imaging at pinpointing the spread of prostate cancer throughout the body. PSMA PET/CT proved to be 92% accurate compared with only 65% accuracy with standard imaging.
Although the study did not assess whether the scans had any effect on patient survival, the researchers say this approach could improve outcomes by helping doctors decide whether to offer a localised treatment, such as surgery or radiotherapy, or to use more advanced treatments to treat the whole body if the cancer has already spread.
Costs associated with PET/CT vary by geographical area and the researchers caution that a full economic analysis will be critical for determining the feasibility of widespread use. Nevertheless, they recommend a review of current clinical guidelines and for PSMA PET/CT to replace the use of conventional imaging where possible for men with high risk prostate cancer.
Prostate cancer is commonly treated by surgery to remove the prostate or intensive radiotherapy to target the tumour. If there is a high risk the cancer may have spread to other parts of the body, patients may be offered medical imaging – typically CT and bone scans – to help doctors determine if additional treatments are needed.
Study lead Professor Michael Hofman of the Peter MacCallum Cancer Centre, Australia, said: “Taken together, our findings indicate that PSMA-PET/CT scans offer greater accuracy than conventional imaging and can better inform treatment decisions. We recommend that clinical guidelines should be updated to include PSMA PET/CT as part of the diagnostic pathway for men with high risk prostate cancer.”
Researchers sought to investigate if a molecular imaging approach could help doctors better define the extent of disease at the time of diagnosis. This approach involves giving patients a radioactive substance that detects prostate specific membrane antigen (PSMA), which is found at high levels on prostate cancer cells. They then undergo a PET/CT scan. The CT scan produces detailed images of the body’s organs and structures, while the PET scan lights up areas where PSMA is present at high levels, indicating the presence of prostate cancer cells.
The study involved 300 men recruited to ten sites across Australia. All of the men had been diagnosed with prostate cancer, confirmed by tests on prostate tissue samples, and were deemed to be at high risk of having aggressive disease. The men were randomly assigned to receive either conventional CT and bone scans (152 patients) or PSMA-PET/CT (148 patients). Men then swapped over and were given the scans using the alternative imaging arm unless more than three sites of cancer spread were detected on the initial scans (18 patients). A low number of men dropped out of the study or follow up information was not available for them (five patients). The remainder were given a second round of medical imaging at their six month follow-up appointment. The results of these scans were used to confirm tumour spread, in addition to biopsies and change in blood tests.
Overall, the researchers found the PSMA-PET/CT scans were much more accurate than conventional CT and bone scans at detecting cancer spread (92% vs 65%). This is because the new technique was better at detecting small sites of tumour spread. Conventional imaging failed to detect that the cancer had spread in 29 patients, giving a false negative result. By comparison, PSMA-PET/CT gave false negative results in just six patients. Furthermore, fewer men had false positive results obtained with the new technique (2 with PSMA-PET/CT and 9 with conventional imaging).
Patients who underwent PSMA-PET/CT scans had fewer ambiguous results than conventional imaging (7%, 11/148 patients vs 23%, 35/152 patients).
Both imaging techniques involve exposure to radiation but the dose associated with PSMA-PET/CT was less than half that associated with conventional imaging (8.4mSv vs 19.2mSv).
PSMA-PET/CT scans had greater impact on the way patients’ disease was managed, with 28% having their treatment plans changed after the scans (41/147) compared with 15% following conventional imaging (23/152).
When PSMA-PET/CT was given at the second round of imaging after conventional imaging, disease management plans were still changed in more than a quarter of cases (39/146, 27%). When conventional imaging was used at the second round, however, just 5% of patients had their treatment plans changed (7/135 patients).
Professor Declan Murphy, senior author, said, “Around one in three prostate cancer patients will experience a disease relapse after surgery or radiotherapy. This is partly because current medical imaging techniques often fail to detect when the cancer has spread, which means some men are not given the additional treatments they need. Our findings suggest PSMA-PET/CT could help identify these men sooner, so they get the most appropriate care.”
Associate Professor Roslyn Francis, co-author, of the University of Western Australia, said: “Costs associated with PSMA-PET/CT vary in different regions of the world but this approach may offer savings over conventional imaging techniques. A full health-economic analysis will help to determine the cost effectiveness of introducing PSMA-PET/CT, both from a patient and a healthcare perspective“
Some patients in the study had undergone further tests to confirm the spread of disease, which involved removing tissue from their pelvic lymph nodes. This is acknowledged as the most reliable test for assessing the stage of prostate cancer disease spread. The researchers caution that as not all patients underwent the procedure, it may lead to an overestimation in the sensitivity of PSMA-PET/CT scans at detecting smaller tumours. However, as patients had been randomly assigned to their groups, the researchers conclude that their study provides robust comparative data.
Writing in a linked Comment article, Professor Caroline Moore, University College London (who was not involved in the study), said: “Introduction of novel imaging into routine practice requires careful assessment of the potential burden to both individuals and to society, taking into account changes in treatment which can result. The proPSMA authors have planned an economic analysis of the potential effect of replacing conventional staging with PSMA-PET, which will be crucial in assessing the feasibility of widespread use of PSMA PET-CT in men being considered for radical treatment for high-risk prostate cancer.”
20th March 2020
The first three guidelines, which will be completed this week, cover the management of patients in critical care, the management of patients who are having kidney dialysis and the management of patients who are receiving systemic anticancer treatments.
Further guidelines will be announced in due course but are likely to include: symptom management; patients receiving radiotherapy; and patients with rheumatoid arthritis. NICE will publish new guidelines each week until the full set has been completed.
NICE will make the guidelines accessible on its website so that health systems around the world can see the approach the UK is taking. NICE guidelines are already used, with permission, around the world and NICE will respond quickly to requests to do so with these new publications.
The guidelines are being produced in collaboration with NHS England/Improvement and a cross-specialty clinical group, supported by the specialist societies and Royal Colleges.
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