Rheumatology News

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

“The sewer is the conscience of the city. Everything there converges and confronts everything else. In that livid spot there are shades, but there are no longer any secrets.” Victor Hugo – “Les Miserables”

To get a sense of the prevalence of COVID-19 in a community you need to test hundreds to thousands of people. This is difficult, resource intensive, and requires cooperation for testing among people both with and without symptoms. It turns out that Sewage Chemical Information Mining (SCIM), a technology that has been in development for over a decade, is now being developed to track COVID-19.

In various locations from China to medieval London, there have been attempts to utilize human excrement for the betterment of mankind, from employing it as fertilizer to processing it to make gunpowder. Such attempts did not always work as planned. The use of sewage for fertilizer in Europe and the United States in the 1840s and 1850s led to the spread of waterborne diseases, including cholera and typhoid. As the importance of sanitary elimination of human waste became ever clearer, ideas and technology for our modern system of sewage management evolved. We have since advanced a great deal, so that all industrialized nations now have a well-developed system for clean water entry, as well as sewage treatment and disposal. Nonetheless, there remains a nagging question of whether human waste could be used for something productive.¹

In the early 2000s, SCIM was developed as a technique to assess population-level human health and disease. In SCIM, untreated sewage is tested for a chemical of interest which reflects a health parameter for a community. Chemicals of interest and usage rates can be calculated for substances as varied as opioids, tobacco, pesticides, and even nonnutritive sweeteners. For instance, relative opioid use can be calculated over time for a given “sewershed” or sewage catchment area. The calculation of community-wide exposure to substances as a means of getting real-time data on shifts of usage without having to collect and collate data from thousands of individuals has been termed wastewater-based epidemiology.

We use urine and stool testing in so many other areas, such as urinalysis, urine drug testing, urine Legionella antigen testing, and stool testing for common pathogens. What a rich source of information is present in the combination of urine and stool that collectively make up sewage! With the average volume of urine per adult being approximately 1 liter daily (and with urine calculated to be approximately 1% of wastewater), accurate analytic techniques can estimate per capita exposure to different substances. Applications of wastewater-based epidemiology have included tracking community prevalence of enteric viral infections, opioid and tobacco use, and many other indicators of health and disease.²

Given the enormous work in the field over the last 2 decades and that SARS-CoV-2 RNA has been detected in feces of both symptomatic and asymptomatic patients, it was only a short conceptual step for those familiar with sewage epidemiology to consider adapting it to assess the prevalence of COVID-19 in a community.

An elegant study collected untreated sewage from southeast Queensland, Australia. The sewage was processed, concentrated, and then tested with reverse transcriptase polymerase chain reaction analysis for SARS-CoV-2 RNA. The number of RNA copies was then entered into an equation that included the population served by the sewage encatchment area, as well as the measured liters of wastewater and grams of feces per day. This provided an estimate of the number of persons infected in the community, and the researchers were able to show reasonable agreement between the numbers estimated by sewage analysis and that found in traditional clinical testing.^3,4

The promise of wastewater-based epidemiology is large. Early research indicates that quantification of viral particles in sewage can be accurately assessed and correlated with the prevalence of the infection in the community. Such levels can then be used to track infection rates of COVID-19 over time, as well as to compare the relative rates in different communities.

Our sewage may hold the answer to accurately and easily tracking COVID-19, and ultimately help us gain a better hold on this disease.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. History of water supply and sanitation. Wikipedia, https://en.wikipedia.org/wiki/History_of_water_supply_and_sanitation.

2. Daughton C. Monitoring wastewater for assessing community health: Sewage Chemical-Information Mining (SCIM). Sci Total Environ. 2017 Nov 29. doi: 10.1016/j.scitotenv.2017.11.102.

3. Ahmed W et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: A proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020 Apr 18. doi: doi.org/10.1016/j.scitotenv.2020.138764.

4. Daughton C. The international imperative to rapidly and inexpensively monitor community-wide COVID-19 infection status and trends. Sci Total Environ. 2020 Mar 23. doi: 10.1016/j.scitotenv.2020.138149.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at [email protected].

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at [email protected].

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at [email protected].

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

Three autoantibodies to newly discovered axial spondyloarthritis peptides may improve early diagnosis of the disease, according to a cross-sectional cohort study reported in Arthritis & Rheumatology.

The Assessment in SpondyloArthritis International Society (ASAS) classification criteria were not intended for diagnosis and do not differentiate well between patients with early axial spondyloarthritis (axSpA) and patients with nonspecific chronic low back pain, note the investigators, who conducted their research under senior investigator Veerle Somers, PhD, professor of molecular biology at Hasselt (Belgium) University and vice dean of the School of Life Sciences at Transnationale Universiteit Limburg, also in Hasselt.

“Therefore, for many patients, axSpA diagnosis may be challenging and is often delayed by several years after the occurrence of first clinical symptoms, posing a problem for early treatment initiation,” they wrote.

The investigators used plasma samples from patients with early disease and an axSpA complementary DNA phage display library developed with synovial tissue to screen for IgG antibodies that displayed significantly higher reactivity to plasma pools from the early axSpA patients than healthy controls.

They then assessed presence of the antibodies with enzyme-linked immunosorbent assays in a mixed cohort (76 patients with early axSpA having mean disease duration of 2.8 years, 75 control patients with nonspecific chronic low back pain, 60 patients with RA, and 94 healthy controls) and in an axSpA-only cohort (174 patients, 79 of whom had early disease with mean disease duration of 1.4 years).

Screening identified antibodies to nine novel peptides – eight peptides showing partial homology to human proteins and one novel axSpA autoantigen, double homeobox protein 4 (DUX4) – that were more commonly present in patients with early axSpA than in healthy controls, Dr. Somers and coinvestigators reported.

Subsequent analyses focused on the three antibodies having the highest positive likelihood ratios for differentiating axSpA from chronic low back pain.

Some 14.2% of the combined group of all patients with early axSpA had at least one antibody in this panel, compared with just 5.3% of the patients with chronic low back pain (P = .0484), corresponding to 95% specificity.

Prevalence did not differ significantly from that in patients with RA (10.0%; P = .5025) or healthy controls (8.4%; P = .2292).

The positive likelihood ratio for confirming early axSpA using the three antibodies was 2.7, on par with the historical ratio of 2.5 seen for C-reactive protein (CRP), the currently used laboratory marker, the investigators noted.

Among the patients with chronic low back pain, the posttest probability for axSpA increased from 79% with presence of inflammatory back pain and positive test results for HLA-B27 and CRP to 91% with addition of testing for the three antibodies.

The researchers proposed that, “in combination with other laboratory markers such as HLA-B27 and CRP, antibodies against our [three peptides] ... could provide a novel tool for the diagnosis of a subset of axSpA patients,” but the three-peptide panel needs to be studied more in larger cohorts of early axSpA patients and controls with low back pain.

Findings in context

“The authors did a number of steps laudably,” James T. Rosenbaum, MD, chair of the division of arthritis and rheumatic diseases and the Edward E. Rosenbaum Professor of Inflammation Research at Oregon Health & Science University, Portland, commented in an interview. Specifically, they used a variety of appropriate controls, had discovery and validation sets, achieved a fairly good sample size, and applied the phage library technique.

“Despite this technological tour de force and the need for a sensitive and specific blood test to diagnose nonradiographic axSpA, this study is preliminary,” he cautioned. “For example, the authors found antibodies to DUX4 in 8% of axSpA patients versus 3% of healthy controls, 4% of patients with chronic low back pain, and 7% with RA. It took a combination of antigens to enhance the diagnostic accuracy of the ASAS criteria to diagnose axSpA. For each antigen that was studied, more than 80% of the axSpA patients had no detectable antibodies.”

Importantly, rheumatic diseases are often immune mediated without being autoimmune, calling into question the role of the antibodies, according to Dr. Rosenbaum.

“Even if further studies validate these observations, additional research needs to be done to support the concept that these antibodies cause disease as opposed to being mere epiphenomena as is suggested by the low prevalence,” he concluded. “Current hypotheses as to the cause of ankylosing spondylitis now point to the microbiome and autoinflammatory rather than autoimmune pathways, but the jury is still out.”

Dr. Somers and three coauthors disclosed having a patent pending on the markers. The study was funded by a personal grant from the Agency for Innovation by Science and Technology Flanders. Dr. Rosenbaum disclosed that he consults for AbbVie, Gilead, Novartis, Pfizer, Roche, and UCB.

SOURCE: Quaden D et al. Arthritis Rheumatol. 2020 Jul 8. doi: 10.1002/art.41427.

Three autoantibodies to newly discovered axial spondyloarthritis peptides may improve early diagnosis of the disease, according to a cross-sectional cohort study reported in Arthritis & Rheumatology.

The Assessment in SpondyloArthritis International Society (ASAS) classification criteria were not intended for diagnosis and do not differentiate well between patients with early axial spondyloarthritis (axSpA) and patients with nonspecific chronic low back pain, note the investigators, who conducted their research under senior investigator Veerle Somers, PhD, professor of molecular biology at Hasselt (Belgium) University and vice dean of the School of Life Sciences at Transnationale Universiteit Limburg, also in Hasselt.

“Therefore, for many patients, axSpA diagnosis may be challenging and is often delayed by several years after the occurrence of first clinical symptoms, posing a problem for early treatment initiation,” they wrote.

The investigators used plasma samples from patients with early disease and an axSpA complementary DNA phage display library developed with synovial tissue to screen for IgG antibodies that displayed significantly higher reactivity to plasma pools from the early axSpA patients than healthy controls.

They then assessed presence of the antibodies with enzyme-linked immunosorbent assays in a mixed cohort (76 patients with early axSpA having mean disease duration of 2.8 years, 75 control patients with nonspecific chronic low back pain, 60 patients with RA, and 94 healthy controls) and in an axSpA-only cohort (174 patients, 79 of whom had early disease with mean disease duration of 1.4 years).

Screening identified antibodies to nine novel peptides – eight peptides showing partial homology to human proteins and one novel axSpA autoantigen, double homeobox protein 4 (DUX4) – that were more commonly present in patients with early axSpA than in healthy controls, Dr. Somers and coinvestigators reported.

Subsequent analyses focused on the three antibodies having the highest positive likelihood ratios for differentiating axSpA from chronic low back pain.

Some 14.2% of the combined group of all patients with early axSpA had at least one antibody in this panel, compared with just 5.3% of the patients with chronic low back pain (P = .0484), corresponding to 95% specificity.

Prevalence did not differ significantly from that in patients with RA (10.0%; P = .5025) or healthy controls (8.4%; P = .2292).

The positive likelihood ratio for confirming early axSpA using the three antibodies was 2.7, on par with the historical ratio of 2.5 seen for C-reactive protein (CRP), the currently used laboratory marker, the investigators noted.

Among the patients with chronic low back pain, the posttest probability for axSpA increased from 79% with presence of inflammatory back pain and positive test results for HLA-B27 and CRP to 91% with addition of testing for the three antibodies.

The researchers proposed that, “in combination with other laboratory markers such as HLA-B27 and CRP, antibodies against our [three peptides] ... could provide a novel tool for the diagnosis of a subset of axSpA patients,” but the three-peptide panel needs to be studied more in larger cohorts of early axSpA patients and controls with low back pain.

Findings in context

“The authors did a number of steps laudably,” James T. Rosenbaum, MD, chair of the division of arthritis and rheumatic diseases and the Edward E. Rosenbaum Professor of Inflammation Research at Oregon Health & Science University, Portland, commented in an interview. Specifically, they used a variety of appropriate controls, had discovery and validation sets, achieved a fairly good sample size, and applied the phage library technique.

“Despite this technological tour de force and the need for a sensitive and specific blood test to diagnose nonradiographic axSpA, this study is preliminary,” he cautioned. “For example, the authors found antibodies to DUX4 in 8% of axSpA patients versus 3% of healthy controls, 4% of patients with chronic low back pain, and 7% with RA. It took a combination of antigens to enhance the diagnostic accuracy of the ASAS criteria to diagnose axSpA. For each antigen that was studied, more than 80% of the axSpA patients had no detectable antibodies.”

Importantly, rheumatic diseases are often immune mediated without being autoimmune, calling into question the role of the antibodies, according to Dr. Rosenbaum.

“Even if further studies validate these observations, additional research needs to be done to support the concept that these antibodies cause disease as opposed to being mere epiphenomena as is suggested by the low prevalence,” he concluded. “Current hypotheses as to the cause of ankylosing spondylitis now point to the microbiome and autoinflammatory rather than autoimmune pathways, but the jury is still out.”

Dr. Somers and three coauthors disclosed having a patent pending on the markers. The study was funded by a personal grant from the Agency for Innovation by Science and Technology Flanders. Dr. Rosenbaum disclosed that he consults for AbbVie, Gilead, Novartis, Pfizer, Roche, and UCB.

SOURCE: Quaden D et al. Arthritis Rheumatol. 2020 Jul 8. doi: 10.1002/art.41427.

Three autoantibodies to newly discovered axial spondyloarthritis peptides may improve early diagnosis of the disease, according to a cross-sectional cohort study reported in Arthritis & Rheumatology.

The Assessment in SpondyloArthritis International Society (ASAS) classification criteria were not intended for diagnosis and do not differentiate well between patients with early axial spondyloarthritis (axSpA) and patients with nonspecific chronic low back pain, note the investigators, who conducted their research under senior investigator Veerle Somers, PhD, professor of molecular biology at Hasselt (Belgium) University and vice dean of the School of Life Sciences at Transnationale Universiteit Limburg, also in Hasselt.

“Therefore, for many patients, axSpA diagnosis may be challenging and is often delayed by several years after the occurrence of first clinical symptoms, posing a problem for early treatment initiation,” they wrote.

The investigators used plasma samples from patients with early disease and an axSpA complementary DNA phage display library developed with synovial tissue to screen for IgG antibodies that displayed significantly higher reactivity to plasma pools from the early axSpA patients than healthy controls.

They then assessed presence of the antibodies with enzyme-linked immunosorbent assays in a mixed cohort (76 patients with early axSpA having mean disease duration of 2.8 years, 75 control patients with nonspecific chronic low back pain, 60 patients with RA, and 94 healthy controls) and in an axSpA-only cohort (174 patients, 79 of whom had early disease with mean disease duration of 1.4 years).

Screening identified antibodies to nine novel peptides – eight peptides showing partial homology to human proteins and one novel axSpA autoantigen, double homeobox protein 4 (DUX4) – that were more commonly present in patients with early axSpA than in healthy controls, Dr. Somers and coinvestigators reported.

Subsequent analyses focused on the three antibodies having the highest positive likelihood ratios for differentiating axSpA from chronic low back pain.

Some 14.2% of the combined group of all patients with early axSpA had at least one antibody in this panel, compared with just 5.3% of the patients with chronic low back pain (P = .0484), corresponding to 95% specificity.

Prevalence did not differ significantly from that in patients with RA (10.0%; P = .5025) or healthy controls (8.4%; P = .2292).

The positive likelihood ratio for confirming early axSpA using the three antibodies was 2.7, on par with the historical ratio of 2.5 seen for C-reactive protein (CRP), the currently used laboratory marker, the investigators noted.

Among the patients with chronic low back pain, the posttest probability for axSpA increased from 79% with presence of inflammatory back pain and positive test results for HLA-B27 and CRP to 91% with addition of testing for the three antibodies.

The researchers proposed that, “in combination with other laboratory markers such as HLA-B27 and CRP, antibodies against our [three peptides] ... could provide a novel tool for the diagnosis of a subset of axSpA patients,” but the three-peptide panel needs to be studied more in larger cohorts of early axSpA patients and controls with low back pain.

Findings in context

“The authors did a number of steps laudably,” James T. Rosenbaum, MD, chair of the division of arthritis and rheumatic diseases and the Edward E. Rosenbaum Professor of Inflammation Research at Oregon Health & Science University, Portland, commented in an interview. Specifically, they used a variety of appropriate controls, had discovery and validation sets, achieved a fairly good sample size, and applied the phage library technique.

“Despite this technological tour de force and the need for a sensitive and specific blood test to diagnose nonradiographic axSpA, this study is preliminary,” he cautioned. “For example, the authors found antibodies to DUX4 in 8% of axSpA patients versus 3% of healthy controls, 4% of patients with chronic low back pain, and 7% with RA. It took a combination of antigens to enhance the diagnostic accuracy of the ASAS criteria to diagnose axSpA. For each antigen that was studied, more than 80% of the axSpA patients had no detectable antibodies.”

Importantly, rheumatic diseases are often immune mediated without being autoimmune, calling into question the role of the antibodies, according to Dr. Rosenbaum.

“Even if further studies validate these observations, additional research needs to be done to support the concept that these antibodies cause disease as opposed to being mere epiphenomena as is suggested by the low prevalence,” he concluded. “Current hypotheses as to the cause of ankylosing spondylitis now point to the microbiome and autoinflammatory rather than autoimmune pathways, but the jury is still out.”

Dr. Somers and three coauthors disclosed having a patent pending on the markers. The study was funded by a personal grant from the Agency for Innovation by Science and Technology Flanders. Dr. Rosenbaum disclosed that he consults for AbbVie, Gilead, Novartis, Pfizer, Roche, and UCB.

SOURCE: Quaden D et al. Arthritis Rheumatol. 2020 Jul 8. doi: 10.1002/art.41427.

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.

The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).