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Agreement reached for research definition of ‘long COVID’ in children and young people
Long COVID can affect adults, young people, and children, and now for the first time, in a landmark study accepted for publication in the Archives of Disease in Childhood, formal agreement has been made on a research definition for post–acute COVID-19, or “long COVID” as it is commonly known, in children and young people.
The researchers charged themselves with a single objective – to derive a research definition for long COVID (post–acute COVID-19) in children and young people to allow comparisons between research studies. Specifically, so studies on prevalence, course, and outcome of long COVID in this age group can be reliably compared, because to date there has been no consensus. In fact, the authors pointed out how the “slew of definitions” currently used all differ in number, type, and duration of symptoms, which hampers research efforts. In addition, the lack of definition consensus has contributed to very wide reported variations in the estimated prevalence of long COVID in children of 1%-51%, with the authors saying that a “consistently applied definition of long COVID will help reduce the variability of prevalence estimates.”
Statements sequentially whittled down
“Using robust consensus methodology,” the authors said, “we derived a research definition for long COVID in children and young people.”
To achieve the definition consensus, a three-phase online Delphi process was used, followed by a virtual consensus meeting. The 123 participants registered to take part in the study included 23 people (19%) in a lived experience panel, 50 (42%) in the researcher or researcher/service delivery combined panel and 47 (39%) in the service delivery panel. Of 120 registered participants, 105 (88%) completed phase 1, 86 eligible participants (82% of those completing phase 1) completed phase 2 and 77 eligible participants (90% of those completing phase 2) completed phase 3. Seventeen participants attended and voted at the consensus meeting – 4 (23%) from the service delivery panel, 11 (65%) from the researcher panel, and 2 (12%) from the lived experience panel.
Presented with 49 statements in each phase, participants scored these from 1-9 based on how important they were perceived to be with regards inclusion in the research definition of long COVID in children and young people. Having been sequentially whittled down in three phases, 10 statements were discussed at the consensus meeting, and a panel of eight 11- to 17-year-olds affected by long COVID also reviewed the statements to reach a final agreement.
Five of the statements were agreed to be included in the definition, which stated that long COVID in children and young people is a condition in which a child or young person has symptoms (at least one of which is a physical symptom) that have continued or developed after a diagnosis of COVID-19 (confirmed with one or more positive COVID tests); impact their physical, mental, or social well-being; are interfering with some aspect of daily living (for example, school, work, home, or relationships); and persist for a minimum duration of 12 weeks after initial testing for COVID-19 (even if symptoms have waxed and waned over that period).
David Strain, MBChB, MD, chair of the BMA board of science and clinical senior lecturer and honorary consultant, University of Exeter (England), told the Science Media Centre: “A Delphi study builds a consensus from the world’s experts by presenting a series of statements and continuing to refine them until there is agreement as to what the definition of pediatric long COVID should be.” He added: “This is vitally important in order to align the global research effort into long COVID.”
Reassuringly similar
From the agreed five statements, a further research definition was proposed to align with the World Health Organization definition for adults: “Post–COVID-19 condition occurs in young people with a history of confirmed SARS CoV-2 infection, with at least one persisting physical symptom for a minimum duration of 12 weeks after initial testing that cannot be explained by an alternative diagnosis. The symptoms have an impact on everyday functioning, may continue or develop after COVID-19 infection, and may fluctuate or relapse over time.”
The authors concluded: “This is the first research definition of long COVID (post–COVID-19 condition) in children and young people and complements the clinical case definition in adults proposed by WHO,” adding that the two definitions are “reassuringly similar.”
They reiterated how widespread adoption of this definition would allow comparisons between studies such that a core outcome set can be developed and the prevalence, course and outcome of long COVID in children and young people can be reliably evaluated, which “will substantially help strengthen the evidence base on this debilitating condition.”
In addition, the authors said that a consistently applied definition of long COVID will help to provide a “more accurate picture on the true impact of the condition.”
The researchers emphasized the need to differentiate between a clinical case definition and a research definition of long COVID and explained: “It is understandable that the patient groups representing people with long COVID are concerned about a definition that could restrict access to services that are needed.”
They went on to say that in their view the decision whether a child or young person can see a health care professional, access any support needed, or be referred, investigated, or treated for long COVID should be a “shared decision involving the young person, their carers, and clinicians.”
Dr. Strain reinforced that it was important that the definition was a research one and not a clinical one, pointing out that the 12-week period in the research definition “does not necessarily mean that a child or young person should need to wait 3 months before being offered help or assistance from their health care team, indeed a 3-month delay in offering support to a child or young person, at this vitally important period of their educational development, could have lasting long-term impacts.”
A version of this article first appeared on Medscape.co.uk.
Long COVID can affect adults, young people, and children, and now for the first time, in a landmark study accepted for publication in the Archives of Disease in Childhood, formal agreement has been made on a research definition for post–acute COVID-19, or “long COVID” as it is commonly known, in children and young people.
The researchers charged themselves with a single objective – to derive a research definition for long COVID (post–acute COVID-19) in children and young people to allow comparisons between research studies. Specifically, so studies on prevalence, course, and outcome of long COVID in this age group can be reliably compared, because to date there has been no consensus. In fact, the authors pointed out how the “slew of definitions” currently used all differ in number, type, and duration of symptoms, which hampers research efforts. In addition, the lack of definition consensus has contributed to very wide reported variations in the estimated prevalence of long COVID in children of 1%-51%, with the authors saying that a “consistently applied definition of long COVID will help reduce the variability of prevalence estimates.”
Statements sequentially whittled down
“Using robust consensus methodology,” the authors said, “we derived a research definition for long COVID in children and young people.”
To achieve the definition consensus, a three-phase online Delphi process was used, followed by a virtual consensus meeting. The 123 participants registered to take part in the study included 23 people (19%) in a lived experience panel, 50 (42%) in the researcher or researcher/service delivery combined panel and 47 (39%) in the service delivery panel. Of 120 registered participants, 105 (88%) completed phase 1, 86 eligible participants (82% of those completing phase 1) completed phase 2 and 77 eligible participants (90% of those completing phase 2) completed phase 3. Seventeen participants attended and voted at the consensus meeting – 4 (23%) from the service delivery panel, 11 (65%) from the researcher panel, and 2 (12%) from the lived experience panel.
Presented with 49 statements in each phase, participants scored these from 1-9 based on how important they were perceived to be with regards inclusion in the research definition of long COVID in children and young people. Having been sequentially whittled down in three phases, 10 statements were discussed at the consensus meeting, and a panel of eight 11- to 17-year-olds affected by long COVID also reviewed the statements to reach a final agreement.
Five of the statements were agreed to be included in the definition, which stated that long COVID in children and young people is a condition in which a child or young person has symptoms (at least one of which is a physical symptom) that have continued or developed after a diagnosis of COVID-19 (confirmed with one or more positive COVID tests); impact their physical, mental, or social well-being; are interfering with some aspect of daily living (for example, school, work, home, or relationships); and persist for a minimum duration of 12 weeks after initial testing for COVID-19 (even if symptoms have waxed and waned over that period).
David Strain, MBChB, MD, chair of the BMA board of science and clinical senior lecturer and honorary consultant, University of Exeter (England), told the Science Media Centre: “A Delphi study builds a consensus from the world’s experts by presenting a series of statements and continuing to refine them until there is agreement as to what the definition of pediatric long COVID should be.” He added: “This is vitally important in order to align the global research effort into long COVID.”
Reassuringly similar
From the agreed five statements, a further research definition was proposed to align with the World Health Organization definition for adults: “Post–COVID-19 condition occurs in young people with a history of confirmed SARS CoV-2 infection, with at least one persisting physical symptom for a minimum duration of 12 weeks after initial testing that cannot be explained by an alternative diagnosis. The symptoms have an impact on everyday functioning, may continue or develop after COVID-19 infection, and may fluctuate or relapse over time.”
The authors concluded: “This is the first research definition of long COVID (post–COVID-19 condition) in children and young people and complements the clinical case definition in adults proposed by WHO,” adding that the two definitions are “reassuringly similar.”
They reiterated how widespread adoption of this definition would allow comparisons between studies such that a core outcome set can be developed and the prevalence, course and outcome of long COVID in children and young people can be reliably evaluated, which “will substantially help strengthen the evidence base on this debilitating condition.”
In addition, the authors said that a consistently applied definition of long COVID will help to provide a “more accurate picture on the true impact of the condition.”
The researchers emphasized the need to differentiate between a clinical case definition and a research definition of long COVID and explained: “It is understandable that the patient groups representing people with long COVID are concerned about a definition that could restrict access to services that are needed.”
They went on to say that in their view the decision whether a child or young person can see a health care professional, access any support needed, or be referred, investigated, or treated for long COVID should be a “shared decision involving the young person, their carers, and clinicians.”
Dr. Strain reinforced that it was important that the definition was a research one and not a clinical one, pointing out that the 12-week period in the research definition “does not necessarily mean that a child or young person should need to wait 3 months before being offered help or assistance from their health care team, indeed a 3-month delay in offering support to a child or young person, at this vitally important period of their educational development, could have lasting long-term impacts.”
A version of this article first appeared on Medscape.co.uk.
Long COVID can affect adults, young people, and children, and now for the first time, in a landmark study accepted for publication in the Archives of Disease in Childhood, formal agreement has been made on a research definition for post–acute COVID-19, or “long COVID” as it is commonly known, in children and young people.
The researchers charged themselves with a single objective – to derive a research definition for long COVID (post–acute COVID-19) in children and young people to allow comparisons between research studies. Specifically, so studies on prevalence, course, and outcome of long COVID in this age group can be reliably compared, because to date there has been no consensus. In fact, the authors pointed out how the “slew of definitions” currently used all differ in number, type, and duration of symptoms, which hampers research efforts. In addition, the lack of definition consensus has contributed to very wide reported variations in the estimated prevalence of long COVID in children of 1%-51%, with the authors saying that a “consistently applied definition of long COVID will help reduce the variability of prevalence estimates.”
Statements sequentially whittled down
“Using robust consensus methodology,” the authors said, “we derived a research definition for long COVID in children and young people.”
To achieve the definition consensus, a three-phase online Delphi process was used, followed by a virtual consensus meeting. The 123 participants registered to take part in the study included 23 people (19%) in a lived experience panel, 50 (42%) in the researcher or researcher/service delivery combined panel and 47 (39%) in the service delivery panel. Of 120 registered participants, 105 (88%) completed phase 1, 86 eligible participants (82% of those completing phase 1) completed phase 2 and 77 eligible participants (90% of those completing phase 2) completed phase 3. Seventeen participants attended and voted at the consensus meeting – 4 (23%) from the service delivery panel, 11 (65%) from the researcher panel, and 2 (12%) from the lived experience panel.
Presented with 49 statements in each phase, participants scored these from 1-9 based on how important they were perceived to be with regards inclusion in the research definition of long COVID in children and young people. Having been sequentially whittled down in three phases, 10 statements were discussed at the consensus meeting, and a panel of eight 11- to 17-year-olds affected by long COVID also reviewed the statements to reach a final agreement.
Five of the statements were agreed to be included in the definition, which stated that long COVID in children and young people is a condition in which a child or young person has symptoms (at least one of which is a physical symptom) that have continued or developed after a diagnosis of COVID-19 (confirmed with one or more positive COVID tests); impact their physical, mental, or social well-being; are interfering with some aspect of daily living (for example, school, work, home, or relationships); and persist for a minimum duration of 12 weeks after initial testing for COVID-19 (even if symptoms have waxed and waned over that period).
David Strain, MBChB, MD, chair of the BMA board of science and clinical senior lecturer and honorary consultant, University of Exeter (England), told the Science Media Centre: “A Delphi study builds a consensus from the world’s experts by presenting a series of statements and continuing to refine them until there is agreement as to what the definition of pediatric long COVID should be.” He added: “This is vitally important in order to align the global research effort into long COVID.”
Reassuringly similar
From the agreed five statements, a further research definition was proposed to align with the World Health Organization definition for adults: “Post–COVID-19 condition occurs in young people with a history of confirmed SARS CoV-2 infection, with at least one persisting physical symptom for a minimum duration of 12 weeks after initial testing that cannot be explained by an alternative diagnosis. The symptoms have an impact on everyday functioning, may continue or develop after COVID-19 infection, and may fluctuate or relapse over time.”
The authors concluded: “This is the first research definition of long COVID (post–COVID-19 condition) in children and young people and complements the clinical case definition in adults proposed by WHO,” adding that the two definitions are “reassuringly similar.”
They reiterated how widespread adoption of this definition would allow comparisons between studies such that a core outcome set can be developed and the prevalence, course and outcome of long COVID in children and young people can be reliably evaluated, which “will substantially help strengthen the evidence base on this debilitating condition.”
In addition, the authors said that a consistently applied definition of long COVID will help to provide a “more accurate picture on the true impact of the condition.”
The researchers emphasized the need to differentiate between a clinical case definition and a research definition of long COVID and explained: “It is understandable that the patient groups representing people with long COVID are concerned about a definition that could restrict access to services that are needed.”
They went on to say that in their view the decision whether a child or young person can see a health care professional, access any support needed, or be referred, investigated, or treated for long COVID should be a “shared decision involving the young person, their carers, and clinicians.”
Dr. Strain reinforced that it was important that the definition was a research one and not a clinical one, pointing out that the 12-week period in the research definition “does not necessarily mean that a child or young person should need to wait 3 months before being offered help or assistance from their health care team, indeed a 3-month delay in offering support to a child or young person, at this vitally important period of their educational development, could have lasting long-term impacts.”
A version of this article first appeared on Medscape.co.uk.
FROM THE ARCHIVES OF DISEASE IN CHILDHOOD
Pioneering test predicts return of malignant melanoma
Their research, published in the British Journal of Dermatology, describes how early-stage melanomas at risk of spreading secrete transforming growth factor beta2 (TGF-beta2), which causes the reduction, or down-regulation, of the proteins AMBRA1 and loricrin, both of which are found in the skin overlaying the tumor. TGF-beta2 also causes the loss of claudin-1, which in turn leads to loss of skin integrity, facilitating ulceration.
Senior author Penny Lovat, PhD, professor of cellular dermatology and oncology at Newcastle University, and chief scientific officer at AMLo Biosciences, explained: “AMBRA1, loricrin, and claudin-1 are all proteins key to maintaining the integrity of the upper layer of the skin,” and that the loss of these proteins causes gaps to develop, allowing the tumor to spread and ulcerate – a process associated with high-risk tumors. Dr. Lovat likened the process to that of “mortar and bricks holding together a wall”, with the loss of these proteins being “like the mortar crumbling away in the wall.”
According to Cancer Research UK, there are over 16,000 new cases of melanoma skin cancer each year in the United Kingdom, with over 2,000 deaths annually. After being surgically removed, primary tumors are histologically staged, with even low-risk cases being followed up for a number of years, a process that can be time-consuming for patients and costly for the NHS.
Some reassurance for those with melanoma
The creators of the new test say that it is these low-risk patients that the test is able to identify, offering a degree of reassurance to those diagnosed with the disease, and potentially reducing the number of hospital clinic visits they require.
Dr. Lovat commented: “Our test offers a personalized prognosis as it more accurately predicts if your skin cancer is unlikely to spread.”
She added that the test will aid clinicians to identify genuinely low-risk patients diagnosed with an early-stage melanoma, reducing the number of follow-up appointments for those identified as low risk. It, therefore, offers the opportunity to save the NHS time and money.
Excellent news for those with skin cancer
Phil Brady, chief operating officer of the British Skin Foundation, echoed Dr. Lovat’s comments, saying: “The test can alleviate stress and anxiety for patients caused by this potentially deadly skin cancer, whilst increasing efficiency and reducing costs to the NHS.”
Nick Levell, MD, consultant dermatologist & British Skin Foundation spokesperson, who has not been involved in the research, commented how the arrival of the test was “excellent news,” adding that “people at low risk can be reassured and will not have to attend hospital so often for check-ups”.
The development of the new test AMBLor has been led by Dr. Lovat, in association with the university spin-out company AMLo Biosciences, and is accredited by the National Accreditation Body for the United Kingdom. The test involves tissue sections from the standard biopsy being sent in the post to the lab for analysis and costs £293 plus VAT. Currently available through a private referral service, the Newcastle team have applied for the test to be made available on the NHS.
A version of this article first appeared on Medscape UK.
Their research, published in the British Journal of Dermatology, describes how early-stage melanomas at risk of spreading secrete transforming growth factor beta2 (TGF-beta2), which causes the reduction, or down-regulation, of the proteins AMBRA1 and loricrin, both of which are found in the skin overlaying the tumor. TGF-beta2 also causes the loss of claudin-1, which in turn leads to loss of skin integrity, facilitating ulceration.
Senior author Penny Lovat, PhD, professor of cellular dermatology and oncology at Newcastle University, and chief scientific officer at AMLo Biosciences, explained: “AMBRA1, loricrin, and claudin-1 are all proteins key to maintaining the integrity of the upper layer of the skin,” and that the loss of these proteins causes gaps to develop, allowing the tumor to spread and ulcerate – a process associated with high-risk tumors. Dr. Lovat likened the process to that of “mortar and bricks holding together a wall”, with the loss of these proteins being “like the mortar crumbling away in the wall.”
According to Cancer Research UK, there are over 16,000 new cases of melanoma skin cancer each year in the United Kingdom, with over 2,000 deaths annually. After being surgically removed, primary tumors are histologically staged, with even low-risk cases being followed up for a number of years, a process that can be time-consuming for patients and costly for the NHS.
Some reassurance for those with melanoma
The creators of the new test say that it is these low-risk patients that the test is able to identify, offering a degree of reassurance to those diagnosed with the disease, and potentially reducing the number of hospital clinic visits they require.
Dr. Lovat commented: “Our test offers a personalized prognosis as it more accurately predicts if your skin cancer is unlikely to spread.”
She added that the test will aid clinicians to identify genuinely low-risk patients diagnosed with an early-stage melanoma, reducing the number of follow-up appointments for those identified as low risk. It, therefore, offers the opportunity to save the NHS time and money.
Excellent news for those with skin cancer
Phil Brady, chief operating officer of the British Skin Foundation, echoed Dr. Lovat’s comments, saying: “The test can alleviate stress and anxiety for patients caused by this potentially deadly skin cancer, whilst increasing efficiency and reducing costs to the NHS.”
Nick Levell, MD, consultant dermatologist & British Skin Foundation spokesperson, who has not been involved in the research, commented how the arrival of the test was “excellent news,” adding that “people at low risk can be reassured and will not have to attend hospital so often for check-ups”.
The development of the new test AMBLor has been led by Dr. Lovat, in association with the university spin-out company AMLo Biosciences, and is accredited by the National Accreditation Body for the United Kingdom. The test involves tissue sections from the standard biopsy being sent in the post to the lab for analysis and costs £293 plus VAT. Currently available through a private referral service, the Newcastle team have applied for the test to be made available on the NHS.
A version of this article first appeared on Medscape UK.
Their research, published in the British Journal of Dermatology, describes how early-stage melanomas at risk of spreading secrete transforming growth factor beta2 (TGF-beta2), which causes the reduction, or down-regulation, of the proteins AMBRA1 and loricrin, both of which are found in the skin overlaying the tumor. TGF-beta2 also causes the loss of claudin-1, which in turn leads to loss of skin integrity, facilitating ulceration.
Senior author Penny Lovat, PhD, professor of cellular dermatology and oncology at Newcastle University, and chief scientific officer at AMLo Biosciences, explained: “AMBRA1, loricrin, and claudin-1 are all proteins key to maintaining the integrity of the upper layer of the skin,” and that the loss of these proteins causes gaps to develop, allowing the tumor to spread and ulcerate – a process associated with high-risk tumors. Dr. Lovat likened the process to that of “mortar and bricks holding together a wall”, with the loss of these proteins being “like the mortar crumbling away in the wall.”
According to Cancer Research UK, there are over 16,000 new cases of melanoma skin cancer each year in the United Kingdom, with over 2,000 deaths annually. After being surgically removed, primary tumors are histologically staged, with even low-risk cases being followed up for a number of years, a process that can be time-consuming for patients and costly for the NHS.
Some reassurance for those with melanoma
The creators of the new test say that it is these low-risk patients that the test is able to identify, offering a degree of reassurance to those diagnosed with the disease, and potentially reducing the number of hospital clinic visits they require.
Dr. Lovat commented: “Our test offers a personalized prognosis as it more accurately predicts if your skin cancer is unlikely to spread.”
She added that the test will aid clinicians to identify genuinely low-risk patients diagnosed with an early-stage melanoma, reducing the number of follow-up appointments for those identified as low risk. It, therefore, offers the opportunity to save the NHS time and money.
Excellent news for those with skin cancer
Phil Brady, chief operating officer of the British Skin Foundation, echoed Dr. Lovat’s comments, saying: “The test can alleviate stress and anxiety for patients caused by this potentially deadly skin cancer, whilst increasing efficiency and reducing costs to the NHS.”
Nick Levell, MD, consultant dermatologist & British Skin Foundation spokesperson, who has not been involved in the research, commented how the arrival of the test was “excellent news,” adding that “people at low risk can be reassured and will not have to attend hospital so often for check-ups”.
The development of the new test AMBLor has been led by Dr. Lovat, in association with the university spin-out company AMLo Biosciences, and is accredited by the National Accreditation Body for the United Kingdom. The test involves tissue sections from the standard biopsy being sent in the post to the lab for analysis and costs £293 plus VAT. Currently available through a private referral service, the Newcastle team have applied for the test to be made available on the NHS.
A version of this article first appeared on Medscape UK.
FROM THE BRITISH JOURNAL OF DERMATOLOGY