“Doomscrolling” or “doomsurfing” the news is fairly common and raises the risk for poor mental as well as poor physical health, new research suggests.

The past 2 years have been filled with worrisome global events, from the pandemic to the war in Ukraine, large-scale protests, mass shootings, and devastating wildfires. The 24-hour media coverage of these events can take a toll on “news addicts” who have an excessive urge to constantly check the news, researchers note.

Results from an online survey of more than 1,000 adults showed that nearly 17% showed signs of “severely problematic” news consumption.

These “doomscrollers” or “doomsurfers” scored high on all five problematic news consumption dimensions: being absorbed in news content, being consumed by thoughts about the news, attempting to alleviate feelings of threat by consuming more news, losing control over news consumption, and having news consumption interfere in daily life.

“We anticipated that a sizable portion of our sample would show signs of problematic news consumption. However, we were surprised to find that 17% of study participants suffer from the most severe level of problematic news consumption,” lead author Bryan McLaughlin, PhD, Texas Tech University, Lubbock, told this news organization. “This is certainly concerning and suggests the problem may be more widespread than we expected,” he said.

Simon Parmley

Emotionally invested

The researchers assessed data from an online survey of 1,100 adults (mean age, 40.5 years; 51% women) in the United States who were recruited in August 2021.

Among those surveyed, 27.3% reported “moderately problematic” news consumption, 27.5% reported minimally problematic news consumption, and 28.7% reported no problematic news consumption.

Perhaps not surprisingly, respondents with higher levels of problematic news consumption were significantly more likely to experience mental and physical ill-being than those with lower levels, even after accounting for demographics, personality traits, and overall news use, the researchers note.

Nearly three-quarters (74%) of those with severe levels of problematic news consumption reported experiencing mental ill-being “quite a bit” or “very much” – whereas frequent symptoms were only reported by 8% of all other study participants.

In addition, 61% of adults with severe problematic news consumption reported experiencing physical ill-being “quite a bit” or “very much,” compared with only 6.1% for all other study participants.

Dr. McLaughlin noted that one way to combat this problem is to help individuals develop a healthier relationship with the news – and mindfulness training may be one way to accomplish that.

“We have some preliminary evidence that individuals with high levels of mindfulness are much less susceptible to developing higher levels of problematic news consumption,” he said.

“Given this, mindfulness-based training could potentially help problematic news consumers follow the news without becoming so emotionally invested in it. We hope to examine the effectiveness of a mindfulness intervention in our future research,” he added.
 

Increased distress

Commenting on the study, Steven R. Thorp, PhD, ABPP, a professor at California School of Professional Psychology, Alliant International University, San Diego, said that he and his colleagues have noticed an increase in clients reporting distress about news consumption.

The survey by Dr. McLaughlin and colleagues “appears to be representative and has sufficient statistical power to address the issues,” said Dr. Thorp, who was not involved with the research.

“However, as the researchers note, it is a cross-sectional and correlational survey. So it’s possible that, as implied, people who ‘doomscroll’ are more likely to have physical and mental health problems that interfere with their functioning,” he added.

It is also possible that individuals with physical and mental health problems are more likely to be isolated and have restricted activities, thus leading to greater news consumption, Dr. Thorp noted. Alternatively, there could be an independent link between health and news consumption.

Most news is “sensational and not representative,” Dr. Thorp pointed out.

For example, “we are far more likely to hear about deaths from terrorist attacks or plane crashes than from heart attacks, though deaths from heart attacks are far more common,” he said.

“News also tends to be negative, rather than uplifting, and most news is not directly relevant to a person’s day-to-day functioning. Thus, for most people, the consumption of news may have more downsides than upsides,” Dr. Thorp added.

Still, many people want to stay informed about national and international events. So rather than following a “cold turkey” or abstinence model of stopping all news consumption, individuals could consider a “harm reduction” model of reducing time spent consuming news, Dr. Thorp noted.

Another thing to consider is the news source. “Some outlets and social media sites are designed to instill outrage, fear, or anger and to increase polarization, while others have been shown to provide balanced and less sensational coverage,” Dr. Thorp said.

“I also think it’s a good idea for providers to regularly ask about news consumption, along with learning about other daily activities that may enhance or diminish mental and physical health,” he added.

The research had no specific funding. Dr. McLaughlin and Dr. Thorp have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

“Doomscrolling” or “doomsurfing” the news is fairly common and raises the risk for poor mental as well as poor physical health, new research suggests.

The past 2 years have been filled with worrisome global events, from the pandemic to the war in Ukraine, large-scale protests, mass shootings, and devastating wildfires. The 24-hour media coverage of these events can take a toll on “news addicts” who have an excessive urge to constantly check the news, researchers note.

Results from an online survey of more than 1,000 adults showed that nearly 17% showed signs of “severely problematic” news consumption.

These “doomscrollers” or “doomsurfers” scored high on all five problematic news consumption dimensions: being absorbed in news content, being consumed by thoughts about the news, attempting to alleviate feelings of threat by consuming more news, losing control over news consumption, and having news consumption interfere in daily life.

“We anticipated that a sizable portion of our sample would show signs of problematic news consumption. However, we were surprised to find that 17% of study participants suffer from the most severe level of problematic news consumption,” lead author Bryan McLaughlin, PhD, Texas Tech University, Lubbock, told this news organization. “This is certainly concerning and suggests the problem may be more widespread than we expected,” he said.

Simon Parmley

Emotionally invested

The researchers assessed data from an online survey of 1,100 adults (mean age, 40.5 years; 51% women) in the United States who were recruited in August 2021.

Among those surveyed, 27.3% reported “moderately problematic” news consumption, 27.5% reported minimally problematic news consumption, and 28.7% reported no problematic news consumption.

Perhaps not surprisingly, respondents with higher levels of problematic news consumption were significantly more likely to experience mental and physical ill-being than those with lower levels, even after accounting for demographics, personality traits, and overall news use, the researchers note.

Nearly three-quarters (74%) of those with severe levels of problematic news consumption reported experiencing mental ill-being “quite a bit” or “very much” – whereas frequent symptoms were only reported by 8% of all other study participants.

In addition, 61% of adults with severe problematic news consumption reported experiencing physical ill-being “quite a bit” or “very much,” compared with only 6.1% for all other study participants.

Dr. McLaughlin noted that one way to combat this problem is to help individuals develop a healthier relationship with the news – and mindfulness training may be one way to accomplish that.

“We have some preliminary evidence that individuals with high levels of mindfulness are much less susceptible to developing higher levels of problematic news consumption,” he said.

“Given this, mindfulness-based training could potentially help problematic news consumers follow the news without becoming so emotionally invested in it. We hope to examine the effectiveness of a mindfulness intervention in our future research,” he added.
 

Increased distress

Commenting on the study, Steven R. Thorp, PhD, ABPP, a professor at California School of Professional Psychology, Alliant International University, San Diego, said that he and his colleagues have noticed an increase in clients reporting distress about news consumption.

The survey by Dr. McLaughlin and colleagues “appears to be representative and has sufficient statistical power to address the issues,” said Dr. Thorp, who was not involved with the research.

“However, as the researchers note, it is a cross-sectional and correlational survey. So it’s possible that, as implied, people who ‘doomscroll’ are more likely to have physical and mental health problems that interfere with their functioning,” he added.

It is also possible that individuals with physical and mental health problems are more likely to be isolated and have restricted activities, thus leading to greater news consumption, Dr. Thorp noted. Alternatively, there could be an independent link between health and news consumption.

Most news is “sensational and not representative,” Dr. Thorp pointed out.

For example, “we are far more likely to hear about deaths from terrorist attacks or plane crashes than from heart attacks, though deaths from heart attacks are far more common,” he said.

“News also tends to be negative, rather than uplifting, and most news is not directly relevant to a person’s day-to-day functioning. Thus, for most people, the consumption of news may have more downsides than upsides,” Dr. Thorp added.

Still, many people want to stay informed about national and international events. So rather than following a “cold turkey” or abstinence model of stopping all news consumption, individuals could consider a “harm reduction” model of reducing time spent consuming news, Dr. Thorp noted.

Another thing to consider is the news source. “Some outlets and social media sites are designed to instill outrage, fear, or anger and to increase polarization, while others have been shown to provide balanced and less sensational coverage,” Dr. Thorp said.

“I also think it’s a good idea for providers to regularly ask about news consumption, along with learning about other daily activities that may enhance or diminish mental and physical health,” he added.

The research had no specific funding. Dr. McLaughlin and Dr. Thorp have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

“Doomscrolling” or “doomsurfing” the news is fairly common and raises the risk for poor mental as well as poor physical health, new research suggests.

The past 2 years have been filled with worrisome global events, from the pandemic to the war in Ukraine, large-scale protests, mass shootings, and devastating wildfires. The 24-hour media coverage of these events can take a toll on “news addicts” who have an excessive urge to constantly check the news, researchers note.

Results from an online survey of more than 1,000 adults showed that nearly 17% showed signs of “severely problematic” news consumption.

These “doomscrollers” or “doomsurfers” scored high on all five problematic news consumption dimensions: being absorbed in news content, being consumed by thoughts about the news, attempting to alleviate feelings of threat by consuming more news, losing control over news consumption, and having news consumption interfere in daily life.

“We anticipated that a sizable portion of our sample would show signs of problematic news consumption. However, we were surprised to find that 17% of study participants suffer from the most severe level of problematic news consumption,” lead author Bryan McLaughlin, PhD, Texas Tech University, Lubbock, told this news organization. “This is certainly concerning and suggests the problem may be more widespread than we expected,” he said.

Simon Parmley

Emotionally invested

The researchers assessed data from an online survey of 1,100 adults (mean age, 40.5 years; 51% women) in the United States who were recruited in August 2021.

Among those surveyed, 27.3% reported “moderately problematic” news consumption, 27.5% reported minimally problematic news consumption, and 28.7% reported no problematic news consumption.

Perhaps not surprisingly, respondents with higher levels of problematic news consumption were significantly more likely to experience mental and physical ill-being than those with lower levels, even after accounting for demographics, personality traits, and overall news use, the researchers note.

Nearly three-quarters (74%) of those with severe levels of problematic news consumption reported experiencing mental ill-being “quite a bit” or “very much” – whereas frequent symptoms were only reported by 8% of all other study participants.

In addition, 61% of adults with severe problematic news consumption reported experiencing physical ill-being “quite a bit” or “very much,” compared with only 6.1% for all other study participants.

Dr. McLaughlin noted that one way to combat this problem is to help individuals develop a healthier relationship with the news – and mindfulness training may be one way to accomplish that.

“We have some preliminary evidence that individuals with high levels of mindfulness are much less susceptible to developing higher levels of problematic news consumption,” he said.

“Given this, mindfulness-based training could potentially help problematic news consumers follow the news without becoming so emotionally invested in it. We hope to examine the effectiveness of a mindfulness intervention in our future research,” he added.
 

Increased distress

Commenting on the study, Steven R. Thorp, PhD, ABPP, a professor at California School of Professional Psychology, Alliant International University, San Diego, said that he and his colleagues have noticed an increase in clients reporting distress about news consumption.

The survey by Dr. McLaughlin and colleagues “appears to be representative and has sufficient statistical power to address the issues,” said Dr. Thorp, who was not involved with the research.

“However, as the researchers note, it is a cross-sectional and correlational survey. So it’s possible that, as implied, people who ‘doomscroll’ are more likely to have physical and mental health problems that interfere with their functioning,” he added.

It is also possible that individuals with physical and mental health problems are more likely to be isolated and have restricted activities, thus leading to greater news consumption, Dr. Thorp noted. Alternatively, there could be an independent link between health and news consumption.

Most news is “sensational and not representative,” Dr. Thorp pointed out.

For example, “we are far more likely to hear about deaths from terrorist attacks or plane crashes than from heart attacks, though deaths from heart attacks are far more common,” he said.

“News also tends to be negative, rather than uplifting, and most news is not directly relevant to a person’s day-to-day functioning. Thus, for most people, the consumption of news may have more downsides than upsides,” Dr. Thorp added.

Still, many people want to stay informed about national and international events. So rather than following a “cold turkey” or abstinence model of stopping all news consumption, individuals could consider a “harm reduction” model of reducing time spent consuming news, Dr. Thorp noted.

Another thing to consider is the news source. “Some outlets and social media sites are designed to instill outrage, fear, or anger and to increase polarization, while others have been shown to provide balanced and less sensational coverage,” Dr. Thorp said.

“I also think it’s a good idea for providers to regularly ask about news consumption, along with learning about other daily activities that may enhance or diminish mental and physical health,” he added.

The research had no specific funding. Dr. McLaughlin and Dr. Thorp have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Background

There are no studies in oncologic literature that report biomarker alterations in Vietnam War veterans with lung cancers. Our study elucidates genetic mutations in veterans with lung cancer exposed to Agent Orange (AO) and compares them to non-Agent Orange exposed (NAO) veterans.

Methods

We collected data of veterans with lung cancers from VA Central California Health Care System who had NGS testing via Foundation One CDx from January 2007 to January 2022. We collected data of AO versus NAO veterans including age, race, gender, smoking and exposure history, histologic subtypes, treatment modalities, PDL-1, and molecular mutations. Median PFS and OS were calculated between AO and NAO in all veterans and adenocarcinoma group after first-line therapy in months by Kaplan-Meier R log-rank test.

Results

There were total of 58 lung cancer veterans, 27 AO and 31 NAO. 33 (56.9%) veterans had adenocarcinoma (20 AO vs 13 NAO). Veterans were White (81%), male (93%) and all had tobacco exposure. The median age at diagnosis was 72 years in both groups. 65.5% had stage III-IV disease. Veterans with AO adenocarcinoma had more early stage I-II disease (50%) as compared to NAO (16%). The AO group had more PDL1 expression (TPS > 1%). 15/31 (48.4%) NAO received immunotherapy vs 7/27 (25.9%) AO. 104 molecular mutations were identified. Veterans with AO had more ROS1, MET, and NRAS while NAO had more EGFR, KRAS, and NF1 mutations. In adenocarcinoma group, AO had more MET and less KRAS while NAO has more KRAS, TP53, and EGFR. The median PFS and OS for all veterans with AO vs NAO were 8 mo vs 6 mo and 12 mo vs 10 mo, respectively (non-significant [NS]). In adenocarcinoma group the median PFS and OS for AO vs NAO veterans were 8 mo vs 4 mo and 11.75 mo vs 6 mo, respectively (NS).

Conclusions

Our study is the first to report molecular biomarkers in AO and NAO veterans with lung cancers. We found different markers between the groups. The median PFS and OS of AO and adenocarcinoma AO veterans were longer due to early stage diagnoses while NAO vetera

Background

There are no studies in oncologic literature that report biomarker alterations in Vietnam War veterans with lung cancers. Our study elucidates genetic mutations in veterans with lung cancer exposed to Agent Orange (AO) and compares them to non-Agent Orange exposed (NAO) veterans.

Methods

We collected data of veterans with lung cancers from VA Central California Health Care System who had NGS testing via Foundation One CDx from January 2007 to January 2022. We collected data of AO versus NAO veterans including age, race, gender, smoking and exposure history, histologic subtypes, treatment modalities, PDL-1, and molecular mutations. Median PFS and OS were calculated between AO and NAO in all veterans and adenocarcinoma group after first-line therapy in months by Kaplan-Meier R log-rank test.

Results

There were total of 58 lung cancer veterans, 27 AO and 31 NAO. 33 (56.9%) veterans had adenocarcinoma (20 AO vs 13 NAO). Veterans were White (81%), male (93%) and all had tobacco exposure. The median age at diagnosis was 72 years in both groups. 65.5% had stage III-IV disease. Veterans with AO adenocarcinoma had more early stage I-II disease (50%) as compared to NAO (16%). The AO group had more PDL1 expression (TPS > 1%). 15/31 (48.4%) NAO received immunotherapy vs 7/27 (25.9%) AO. 104 molecular mutations were identified. Veterans with AO had more ROS1, MET, and NRAS while NAO had more EGFR, KRAS, and NF1 mutations. In adenocarcinoma group, AO had more MET and less KRAS while NAO has more KRAS, TP53, and EGFR. The median PFS and OS for all veterans with AO vs NAO were 8 mo vs 6 mo and 12 mo vs 10 mo, respectively (non-significant [NS]). In adenocarcinoma group the median PFS and OS for AO vs NAO veterans were 8 mo vs 4 mo and 11.75 mo vs 6 mo, respectively (NS).

Conclusions

Our study is the first to report molecular biomarkers in AO and NAO veterans with lung cancers. We found different markers between the groups. The median PFS and OS of AO and adenocarcinoma AO veterans were longer due to early stage diagnoses while NAO vetera

Background

There are no studies in oncologic literature that report biomarker alterations in Vietnam War veterans with lung cancers. Our study elucidates genetic mutations in veterans with lung cancer exposed to Agent Orange (AO) and compares them to non-Agent Orange exposed (NAO) veterans.

Methods

We collected data of veterans with lung cancers from VA Central California Health Care System who had NGS testing via Foundation One CDx from January 2007 to January 2022. We collected data of AO versus NAO veterans including age, race, gender, smoking and exposure history, histologic subtypes, treatment modalities, PDL-1, and molecular mutations. Median PFS and OS were calculated between AO and NAO in all veterans and adenocarcinoma group after first-line therapy in months by Kaplan-Meier R log-rank test.

Results

There were total of 58 lung cancer veterans, 27 AO and 31 NAO. 33 (56.9%) veterans had adenocarcinoma (20 AO vs 13 NAO). Veterans were White (81%), male (93%) and all had tobacco exposure. The median age at diagnosis was 72 years in both groups. 65.5% had stage III-IV disease. Veterans with AO adenocarcinoma had more early stage I-II disease (50%) as compared to NAO (16%). The AO group had more PDL1 expression (TPS > 1%). 15/31 (48.4%) NAO received immunotherapy vs 7/27 (25.9%) AO. 104 molecular mutations were identified. Veterans with AO had more ROS1, MET, and NRAS while NAO had more EGFR, KRAS, and NF1 mutations. In adenocarcinoma group, AO had more MET and less KRAS while NAO has more KRAS, TP53, and EGFR. The median PFS and OS for all veterans with AO vs NAO were 8 mo vs 6 mo and 12 mo vs 10 mo, respectively (non-significant [NS]). In adenocarcinoma group the median PFS and OS for AO vs NAO veterans were 8 mo vs 4 mo and 11.75 mo vs 6 mo, respectively (NS).

Conclusions

Our study is the first to report molecular biomarkers in AO and NAO veterans with lung cancers. We found different markers between the groups. The median PFS and OS of AO and adenocarcinoma AO veterans were longer due to early stage diagnoses while NAO vetera

Introduction

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers. Nextgeneration sequencing (NGS) has been recommended as a tool to help guide treatment by identifying actionable genetic mutations. However, data regarding realworld usage of NGS in a Veterans Affairs (VA) health care system is lacking. We conducted a retrospective observational study of the patterns of NGS usage in patients with mCRC at the South Texas Veterans Affairs Healthcare System (STVAHCS).

Methods

We identified patients with a diagnosis of mCRC evaluated and treated at STVAHCS between January 1, 2018 and June 1, 2022. We assessed the prevalence of utilizing NGS on solid tumor samples performed by Foundation One and identified the presence of different molecular aberrations detected by NGS.

Results

65 patients were identified. Median age was 68 years. 63 (96.9%) were males and 2 (3.1%) were females. 29 (44.6%) were Hispanic, 25 (38.5%) were White, 10 (15.4%) were African American and 1 (1.5%) was Pacific Islander. NGS was performed in 34 (52.3%) patients. The most common reasons for not performing NGS were unknown/not documented (54.8%), early mortality (29%), lack of adequate tissue (12.9%) and patient refusal of treatment (3.2%). The most common molecular aberrations identified in patients who had NGS were TP53 (73.5%), APC (64.7%), KRAS (47.1%), ATM (20.6%), SMAD4 (14.7%) and BRAF (14.7%). All patients who had NGS were found to have at least one identifiable mutation.

Conclusions

 Approximately 50% of patients with mCRC did not have NGS performed on their tissue sample. This rate is similar to other real-world studies in non-VA settings. Documented reasons for lack of NGS testing included inadequate tissue and early patient mortality. Other potential reasons could be lack of efficient VA clinical testing protocols, use of simple molecular testing rather than comprehensive NGS testing and limited knowledge of availability of NGS among providers. Measures that can be taken to increase utilization of NGS include incorporating NGS testing early in the disease course, incorporating testing into VA clinical pathways, improving physician education, increasing the size of solid tissue samples and ordering liquid biopsies where solid tissue is deficient.

Introduction

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers. Nextgeneration sequencing (NGS) has been recommended as a tool to help guide treatment by identifying actionable genetic mutations. However, data regarding realworld usage of NGS in a Veterans Affairs (VA) health care system is lacking. We conducted a retrospective observational study of the patterns of NGS usage in patients with mCRC at the South Texas Veterans Affairs Healthcare System (STVAHCS).

Methods

We identified patients with a diagnosis of mCRC evaluated and treated at STVAHCS between January 1, 2018 and June 1, 2022. We assessed the prevalence of utilizing NGS on solid tumor samples performed by Foundation One and identified the presence of different molecular aberrations detected by NGS.

Results

65 patients were identified. Median age was 68 years. 63 (96.9%) were males and 2 (3.1%) were females. 29 (44.6%) were Hispanic, 25 (38.5%) were White, 10 (15.4%) were African American and 1 (1.5%) was Pacific Islander. NGS was performed in 34 (52.3%) patients. The most common reasons for not performing NGS were unknown/not documented (54.8%), early mortality (29%), lack of adequate tissue (12.9%) and patient refusal of treatment (3.2%). The most common molecular aberrations identified in patients who had NGS were TP53 (73.5%), APC (64.7%), KRAS (47.1%), ATM (20.6%), SMAD4 (14.7%) and BRAF (14.7%). All patients who had NGS were found to have at least one identifiable mutation.

Conclusions

 Approximately 50% of patients with mCRC did not have NGS performed on their tissue sample. This rate is similar to other real-world studies in non-VA settings. Documented reasons for lack of NGS testing included inadequate tissue and early patient mortality. Other potential reasons could be lack of efficient VA clinical testing protocols, use of simple molecular testing rather than comprehensive NGS testing and limited knowledge of availability of NGS among providers. Measures that can be taken to increase utilization of NGS include incorporating NGS testing early in the disease course, incorporating testing into VA clinical pathways, improving physician education, increasing the size of solid tissue samples and ordering liquid biopsies where solid tissue is deficient.

Introduction

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers. Nextgeneration sequencing (NGS) has been recommended as a tool to help guide treatment by identifying actionable genetic mutations. However, data regarding realworld usage of NGS in a Veterans Affairs (VA) health care system is lacking. We conducted a retrospective observational study of the patterns of NGS usage in patients with mCRC at the South Texas Veterans Affairs Healthcare System (STVAHCS).

Methods

We identified patients with a diagnosis of mCRC evaluated and treated at STVAHCS between January 1, 2018 and June 1, 2022. We assessed the prevalence of utilizing NGS on solid tumor samples performed by Foundation One and identified the presence of different molecular aberrations detected by NGS.

Results

65 patients were identified. Median age was 68 years. 63 (96.9%) were males and 2 (3.1%) were females. 29 (44.6%) were Hispanic, 25 (38.5%) were White, 10 (15.4%) were African American and 1 (1.5%) was Pacific Islander. NGS was performed in 34 (52.3%) patients. The most common reasons for not performing NGS were unknown/not documented (54.8%), early mortality (29%), lack of adequate tissue (12.9%) and patient refusal of treatment (3.2%). The most common molecular aberrations identified in patients who had NGS were TP53 (73.5%), APC (64.7%), KRAS (47.1%), ATM (20.6%), SMAD4 (14.7%) and BRAF (14.7%). All patients who had NGS were found to have at least one identifiable mutation.

Conclusions

 Approximately 50% of patients with mCRC did not have NGS performed on their tissue sample. This rate is similar to other real-world studies in non-VA settings. Documented reasons for lack of NGS testing included inadequate tissue and early patient mortality. Other potential reasons could be lack of efficient VA clinical testing protocols, use of simple molecular testing rather than comprehensive NGS testing and limited knowledge of availability of NGS among providers. Measures that can be taken to increase utilization of NGS include incorporating NGS testing early in the disease course, incorporating testing into VA clinical pathways, improving physician education, increasing the size of solid tissue samples and ordering liquid biopsies where solid tissue is deficient.

The passage of time felt altered for many people during the COVID-19 pandemic, ranging from difficulty keeping track of the days of the week to feeling that the hours either crawled by or sped up, new research suggests.

Results showed the sense of present focus, blurring weekdays and weekends together, and uncertainly about the future were reported by over 65% of the 5,661 survey respondents. And more than half reported the experience of feeling “time speeding up or slowing down,” report the investigators, led by E. Alison Holman, PhD, professor at the University of California, Irvine.

Significant predictors of these time distortions included being exposed to daily pandemic-related media and having a mental health diagnosis prior to the pandemic; secondary stress such as school closures and lockdown; financial stress; lifetime stress; and lifetime trauma exposure.

“Continuity between past experiences, present life, and future hopes is critical to one’s well-being, and disruption of that synergy presents mental health challenges,” Dr. Holman said in a news release.

“We were able to measure this in a nationally representative sample of Americans as they were experiencing a protracted collective trauma, which has never been done before, and this study is the first to document the prevalence and early predictors of these time distortions,” added Dr. Holman.

The findings were published online in Psychological Trauma: Theory, Research, Practice, and Policy.
 

Unique opportunity

During the pandemic, many people’s time perspective (TP), defined as “our view of time as it spans from our past into the future,” shifted as they “focused on the immediate, present danger of the COVID-19 pandemic and future plans became uncertain,” the investigators wrote.

Studies of convenience samples “suggested that many people experienced time slowing down, stopping, and/or speeding up as they coped with the challenges of the pandemic” – a phenomenon known as temporal disintegration (TD) in psychiatric literature.

Dr. Holman said in an interview that she researched TD after the Sept.11, 2001 World Trade Center attacks.

“We found that people who experienced that early sense of TD, the sense of ‘time falling apart,’ were more prone to getting stuck in the past and staying focused on the past event,” which led to feeling “more distress over time,” she said.

Research examining the prevalence of and psychosocial factors predicting TD are “quite rare” and studies examining TD “during an unfolding, protracted collective trauma are even rarer,” the researchers note. The COVID pandemic “presented a unique opportunity to conduct such a study,” the researchers wrote.

For their study, the investigators surveyed participants in the NORC AmeriSpeak online panel, a “probability-based panel” of 35,000 U.S. households selected at random from across the country.

The study was conducted in two waves: the first survey was administered March–April 2020, the second in September–October 2020.
 

Speeding up, slowing down

At wave 2, participants completed a 7-item index of TD symptoms experienced over the previous 6 months. To adjust for psychological processes that may have predisposed individuals to experience TD during the pandemic, the researchers included a Wave 1 measure of future uncertainty as a covariate.

Prepandemic health data had been collected prior to the current study.

Wave 1 participants completed a checklist reporting personal, work, and community-wide exposure to the COVID outbreak, including contracting the virus, sheltering in place, and experiencing secondary stressors. The extent and type of pandemic-related media exposure were also assessed.

At wave 2, they reported the extent of exposure to the coronavirus, financial exposures, and secondary stressors. They also completed a non–COVID-related stress/trauma exposure checklist and were asked to indicate whether the trauma, disaster, or bereavement took place prior to or during the pandemic.

The final sample consisted of 5,661 adults (52% female) who completed the wave 2 survey. Participants were divided into four age groups: 18-34, 35-49, 50-64, and 65 and older.

The most common experiences (reported by more than 65% of respondents) included being focused on the present moment, feeling that weekdays and weekends were the same, and feeling uncertain about the future.

Over half of respondents (50.4%) reported feeling as though time was speeding up, and 55.2% reported feeling as though time was slowing down. Some also reported feeling uncertain about the time of day (46.4%) and forgetting events they had just experienced (35.2%).

When the researchers controlled for feeling uncertain about the future, they found that women reported more TD than men (b = 0.11; 95% confidence interval, 0.07-0.14; P < .001).

At wave 1, associations were found between TD and COVID-related media exposure, prepandemic mental health diagnoses, and prepandemic non–COVID-related stress and trauma. At wave 2, associations were found between TD and COVID-related secondary and financial stressors (P < .001 for all).

In contrast, COVID-related work exposure at wave 1, being 45-59 years old, and living in the Midwest region were negatively associated with TD.

“The sense of the flow of the past into the present, and the present into the future is important for our mental health,” Dr. Holman said. “We need to remember who we have been, how that shaped who we are today, and where we want to go with our lives.”

Staying in the present moment is “good, when you’re doing it mindfully. But you still need to feel you can shape and work toward the future and have some sense of control,” she added.

Dr. Homan also recommended time-perspective therapy, which helps patients with PTSD to “build continuity across time – to understand and learn from the past, live in the present, and move toward the future.”
 

Widespread distortion

In an interview, Ruth Ogden, PhD, a lecturer at Liverpool (England) John Moores University, said the findings “confirm those reported in Europe, South America, and the Middle East, that widespread distortion to time was common during the pandemic and that distortions to time were greatest amongst those most negatively affected by the pandemic.”

The results also support her own recent research in the United Kingdom “suggesting that distortions to time during the pandemic extend to our memory for the length of the pandemic, with most people believing that lockdowns lasted far longer than they actually did,” said Dr. Ogden, who was not involved with Dr. Holman and colleagues’ current study.

“This type of subjective lengthening of the pandemic may reinforce trauma by making the traumatic period seem longer, further damaging health and well-being,” she noted. “As the negative fallouts of the pandemic continue, it is important to establish the long-term effects of time distortions during the pandemic on mental health and well-being.”

The study was funded by U.S. National Science Foundation and the National Institute on Minority Health and Health Disparities. The investigators reported no relevant financial relationships. Dr. Ogden receives funding from the Wellcome Trust.

A version of this article first appeared on Medscape.com.

The passage of time felt altered for many people during the COVID-19 pandemic, ranging from difficulty keeping track of the days of the week to feeling that the hours either crawled by or sped up, new research suggests.

Results showed the sense of present focus, blurring weekdays and weekends together, and uncertainly about the future were reported by over 65% of the 5,661 survey respondents. And more than half reported the experience of feeling “time speeding up or slowing down,” report the investigators, led by E. Alison Holman, PhD, professor at the University of California, Irvine.

Significant predictors of these time distortions included being exposed to daily pandemic-related media and having a mental health diagnosis prior to the pandemic; secondary stress such as school closures and lockdown; financial stress; lifetime stress; and lifetime trauma exposure.

“Continuity between past experiences, present life, and future hopes is critical to one’s well-being, and disruption of that synergy presents mental health challenges,” Dr. Holman said in a news release.

“We were able to measure this in a nationally representative sample of Americans as they were experiencing a protracted collective trauma, which has never been done before, and this study is the first to document the prevalence and early predictors of these time distortions,” added Dr. Holman.

The findings were published online in Psychological Trauma: Theory, Research, Practice, and Policy.
 

Unique opportunity

During the pandemic, many people’s time perspective (TP), defined as “our view of time as it spans from our past into the future,” shifted as they “focused on the immediate, present danger of the COVID-19 pandemic and future plans became uncertain,” the investigators wrote.

Studies of convenience samples “suggested that many people experienced time slowing down, stopping, and/or speeding up as they coped with the challenges of the pandemic” – a phenomenon known as temporal disintegration (TD) in psychiatric literature.

Dr. Holman said in an interview that she researched TD after the Sept.11, 2001 World Trade Center attacks.

“We found that people who experienced that early sense of TD, the sense of ‘time falling apart,’ were more prone to getting stuck in the past and staying focused on the past event,” which led to feeling “more distress over time,” she said.

Research examining the prevalence of and psychosocial factors predicting TD are “quite rare” and studies examining TD “during an unfolding, protracted collective trauma are even rarer,” the researchers note. The COVID pandemic “presented a unique opportunity to conduct such a study,” the researchers wrote.

For their study, the investigators surveyed participants in the NORC AmeriSpeak online panel, a “probability-based panel” of 35,000 U.S. households selected at random from across the country.

The study was conducted in two waves: the first survey was administered March–April 2020, the second in September–October 2020.
 

Speeding up, slowing down

At wave 2, participants completed a 7-item index of TD symptoms experienced over the previous 6 months. To adjust for psychological processes that may have predisposed individuals to experience TD during the pandemic, the researchers included a Wave 1 measure of future uncertainty as a covariate.

Prepandemic health data had been collected prior to the current study.

Wave 1 participants completed a checklist reporting personal, work, and community-wide exposure to the COVID outbreak, including contracting the virus, sheltering in place, and experiencing secondary stressors. The extent and type of pandemic-related media exposure were also assessed.

At wave 2, they reported the extent of exposure to the coronavirus, financial exposures, and secondary stressors. They also completed a non–COVID-related stress/trauma exposure checklist and were asked to indicate whether the trauma, disaster, or bereavement took place prior to or during the pandemic.

The final sample consisted of 5,661 adults (52% female) who completed the wave 2 survey. Participants were divided into four age groups: 18-34, 35-49, 50-64, and 65 and older.

The most common experiences (reported by more than 65% of respondents) included being focused on the present moment, feeling that weekdays and weekends were the same, and feeling uncertain about the future.

Over half of respondents (50.4%) reported feeling as though time was speeding up, and 55.2% reported feeling as though time was slowing down. Some also reported feeling uncertain about the time of day (46.4%) and forgetting events they had just experienced (35.2%).

When the researchers controlled for feeling uncertain about the future, they found that women reported more TD than men (b = 0.11; 95% confidence interval, 0.07-0.14; P < .001).

At wave 1, associations were found between TD and COVID-related media exposure, prepandemic mental health diagnoses, and prepandemic non–COVID-related stress and trauma. At wave 2, associations were found between TD and COVID-related secondary and financial stressors (P < .001 for all).

In contrast, COVID-related work exposure at wave 1, being 45-59 years old, and living in the Midwest region were negatively associated with TD.

“The sense of the flow of the past into the present, and the present into the future is important for our mental health,” Dr. Holman said. “We need to remember who we have been, how that shaped who we are today, and where we want to go with our lives.”

Staying in the present moment is “good, when you’re doing it mindfully. But you still need to feel you can shape and work toward the future and have some sense of control,” she added.

Dr. Homan also recommended time-perspective therapy, which helps patients with PTSD to “build continuity across time – to understand and learn from the past, live in the present, and move toward the future.”
 

Widespread distortion

In an interview, Ruth Ogden, PhD, a lecturer at Liverpool (England) John Moores University, said the findings “confirm those reported in Europe, South America, and the Middle East, that widespread distortion to time was common during the pandemic and that distortions to time were greatest amongst those most negatively affected by the pandemic.”

The results also support her own recent research in the United Kingdom “suggesting that distortions to time during the pandemic extend to our memory for the length of the pandemic, with most people believing that lockdowns lasted far longer than they actually did,” said Dr. Ogden, who was not involved with Dr. Holman and colleagues’ current study.

“This type of subjective lengthening of the pandemic may reinforce trauma by making the traumatic period seem longer, further damaging health and well-being,” she noted. “As the negative fallouts of the pandemic continue, it is important to establish the long-term effects of time distortions during the pandemic on mental health and well-being.”

The study was funded by U.S. National Science Foundation and the National Institute on Minority Health and Health Disparities. The investigators reported no relevant financial relationships. Dr. Ogden receives funding from the Wellcome Trust.

A version of this article first appeared on Medscape.com.

The passage of time felt altered for many people during the COVID-19 pandemic, ranging from difficulty keeping track of the days of the week to feeling that the hours either crawled by or sped up, new research suggests.

Results showed the sense of present focus, blurring weekdays and weekends together, and uncertainly about the future were reported by over 65% of the 5,661 survey respondents. And more than half reported the experience of feeling “time speeding up or slowing down,” report the investigators, led by E. Alison Holman, PhD, professor at the University of California, Irvine.

Significant predictors of these time distortions included being exposed to daily pandemic-related media and having a mental health diagnosis prior to the pandemic; secondary stress such as school closures and lockdown; financial stress; lifetime stress; and lifetime trauma exposure.

“Continuity between past experiences, present life, and future hopes is critical to one’s well-being, and disruption of that synergy presents mental health challenges,” Dr. Holman said in a news release.

“We were able to measure this in a nationally representative sample of Americans as they were experiencing a protracted collective trauma, which has never been done before, and this study is the first to document the prevalence and early predictors of these time distortions,” added Dr. Holman.

The findings were published online in Psychological Trauma: Theory, Research, Practice, and Policy.
 

Unique opportunity

During the pandemic, many people’s time perspective (TP), defined as “our view of time as it spans from our past into the future,” shifted as they “focused on the immediate, present danger of the COVID-19 pandemic and future plans became uncertain,” the investigators wrote.

Studies of convenience samples “suggested that many people experienced time slowing down, stopping, and/or speeding up as they coped with the challenges of the pandemic” – a phenomenon known as temporal disintegration (TD) in psychiatric literature.

Dr. Holman said in an interview that she researched TD after the Sept.11, 2001 World Trade Center attacks.

“We found that people who experienced that early sense of TD, the sense of ‘time falling apart,’ were more prone to getting stuck in the past and staying focused on the past event,” which led to feeling “more distress over time,” she said.

Research examining the prevalence of and psychosocial factors predicting TD are “quite rare” and studies examining TD “during an unfolding, protracted collective trauma are even rarer,” the researchers note. The COVID pandemic “presented a unique opportunity to conduct such a study,” the researchers wrote.

For their study, the investigators surveyed participants in the NORC AmeriSpeak online panel, a “probability-based panel” of 35,000 U.S. households selected at random from across the country.

The study was conducted in two waves: the first survey was administered March–April 2020, the second in September–October 2020.
 

Speeding up, slowing down

At wave 2, participants completed a 7-item index of TD symptoms experienced over the previous 6 months. To adjust for psychological processes that may have predisposed individuals to experience TD during the pandemic, the researchers included a Wave 1 measure of future uncertainty as a covariate.

Prepandemic health data had been collected prior to the current study.

Wave 1 participants completed a checklist reporting personal, work, and community-wide exposure to the COVID outbreak, including contracting the virus, sheltering in place, and experiencing secondary stressors. The extent and type of pandemic-related media exposure were also assessed.

At wave 2, they reported the extent of exposure to the coronavirus, financial exposures, and secondary stressors. They also completed a non–COVID-related stress/trauma exposure checklist and were asked to indicate whether the trauma, disaster, or bereavement took place prior to or during the pandemic.

The final sample consisted of 5,661 adults (52% female) who completed the wave 2 survey. Participants were divided into four age groups: 18-34, 35-49, 50-64, and 65 and older.

The most common experiences (reported by more than 65% of respondents) included being focused on the present moment, feeling that weekdays and weekends were the same, and feeling uncertain about the future.

Over half of respondents (50.4%) reported feeling as though time was speeding up, and 55.2% reported feeling as though time was slowing down. Some also reported feeling uncertain about the time of day (46.4%) and forgetting events they had just experienced (35.2%).

When the researchers controlled for feeling uncertain about the future, they found that women reported more TD than men (b = 0.11; 95% confidence interval, 0.07-0.14; P < .001).

At wave 1, associations were found between TD and COVID-related media exposure, prepandemic mental health diagnoses, and prepandemic non–COVID-related stress and trauma. At wave 2, associations were found between TD and COVID-related secondary and financial stressors (P < .001 for all).

In contrast, COVID-related work exposure at wave 1, being 45-59 years old, and living in the Midwest region were negatively associated with TD.

“The sense of the flow of the past into the present, and the present into the future is important for our mental health,” Dr. Holman said. “We need to remember who we have been, how that shaped who we are today, and where we want to go with our lives.”

Staying in the present moment is “good, when you’re doing it mindfully. But you still need to feel you can shape and work toward the future and have some sense of control,” she added.

Dr. Homan also recommended time-perspective therapy, which helps patients with PTSD to “build continuity across time – to understand and learn from the past, live in the present, and move toward the future.”
 

Widespread distortion

In an interview, Ruth Ogden, PhD, a lecturer at Liverpool (England) John Moores University, said the findings “confirm those reported in Europe, South America, and the Middle East, that widespread distortion to time was common during the pandemic and that distortions to time were greatest amongst those most negatively affected by the pandemic.”

The results also support her own recent research in the United Kingdom “suggesting that distortions to time during the pandemic extend to our memory for the length of the pandemic, with most people believing that lockdowns lasted far longer than they actually did,” said Dr. Ogden, who was not involved with Dr. Holman and colleagues’ current study.

“This type of subjective lengthening of the pandemic may reinforce trauma by making the traumatic period seem longer, further damaging health and well-being,” she noted. “As the negative fallouts of the pandemic continue, it is important to establish the long-term effects of time distortions during the pandemic on mental health and well-being.”

The study was funded by U.S. National Science Foundation and the National Institute on Minority Health and Health Disparities. The investigators reported no relevant financial relationships. Dr. Ogden receives funding from the Wellcome Trust.

A version of this article first appeared on Medscape.com.

Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.

That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.

“During the past few decades, smoking has substantially declined in the U.S., followed by great declines in mortality from lung cancer and some other smoking-related cancers,” said lead author Farhad Islami, MD, senior scientific director of cancer disparity research at the American Cancer Society.

AtnoYdur/Thinkstock

Despite this “remarkable progress, our results indicate that smoking is still associated with about 30% of all cancer deaths and substantial lost earnings in the U.S., and that more work should be done to further reduce smoking in the country,” he said.

The study was published online in the International Journal of Cancer.

Dr. Islami and colleagues had found that lost earnings from cancer deaths in 2015 came to nearly $95 billion. Other research showed that a substantial portion of lost earnings from cancer deaths could be traced to cigarette smoking, but estimates were more than a decade old.

To provide more recent estimates and help guide tobacco control policies, Dr. Islami and colleagues estimated person-years of life lost (PYLL) and lost earnings from cigarette smoking-related cancer deaths in 2019.

Of the 418,563 cancer deaths in adults ages 25-79 years, an estimated 122,951 could be linked to cigarette smoking. That corresponds to 29.4% of all cancer deaths and roughly 2.2 million PYLL. Translated to lost earnings, the authors estimated $20.9 billion total, with average lost earnings of $170,000 per cancer death linked to smoking.

By cancer type, lung cancer accounted for about 62%, or $12.9 billion, of the total lost earnings linked to smoking, followed by esophageal cancer (7%, or $1.5 billion), colorectal cancer (6%, or $1.2 billion), and liver cancer (5%, or $1.1 billion).

Smoking-related death rates were highest in the 13 “tobacco nation” states with weaker tobacco control policies and a higher rate of cigarette smoking. These states are Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia.

The lost earnings rate in all 13 tobacco nation states combined was about 44% higher, compared with other states and the District of Columbia combined, and the annual PYLL rate was 47% higher in tobacco nation states.

The researchers estimated that if PYLL and lost earnings rates in all states matched those in Utah, which has the lowest rates, more than half of the total PYLL and lost earnings nationally would have been avoided. In other words, that would mean 1.27 million PYLL and $10.5 billion saved in 2019.

Ending the ‘scourge of tobacco’

To kick the smoking habit, health providers should “screen patients for tobacco use, document tobacco use status, advise people who smoke to quit, and assist in attempts to quit,” Dr. Islami said.

Getting more people to screen for lung cancer in the United States is also important, given that only 6.6% of eligible people in 2019 received screening.

In a statement, Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said this report “further demonstrates just how critical reducing tobacco use is to ending suffering and death from cancer.”

To end the “scourge of tobacco,” local, state, and federal lawmakers need to pass proven tobacco control policies, she said.

These include regular and significant tobacco tax increases, thorough statewide smoke-free laws, and enough funding for state programs to prevent and stop smoking. It also means ensuring all Medicaid enrollees have access to all services that can help smokers quit as well as access to all FDA-approved medications that help users stop smoking.

“We have the tools to get this done, we just need lawmakers to act,” Ms. Lacasse said.

A version of this article first appeared on WebMD.com.

Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.

That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.

“During the past few decades, smoking has substantially declined in the U.S., followed by great declines in mortality from lung cancer and some other smoking-related cancers,” said lead author Farhad Islami, MD, senior scientific director of cancer disparity research at the American Cancer Society.

AtnoYdur/Thinkstock

Despite this “remarkable progress, our results indicate that smoking is still associated with about 30% of all cancer deaths and substantial lost earnings in the U.S., and that more work should be done to further reduce smoking in the country,” he said.

The study was published online in the International Journal of Cancer.

Dr. Islami and colleagues had found that lost earnings from cancer deaths in 2015 came to nearly $95 billion. Other research showed that a substantial portion of lost earnings from cancer deaths could be traced to cigarette smoking, but estimates were more than a decade old.

To provide more recent estimates and help guide tobacco control policies, Dr. Islami and colleagues estimated person-years of life lost (PYLL) and lost earnings from cigarette smoking-related cancer deaths in 2019.

Of the 418,563 cancer deaths in adults ages 25-79 years, an estimated 122,951 could be linked to cigarette smoking. That corresponds to 29.4% of all cancer deaths and roughly 2.2 million PYLL. Translated to lost earnings, the authors estimated $20.9 billion total, with average lost earnings of $170,000 per cancer death linked to smoking.

By cancer type, lung cancer accounted for about 62%, or $12.9 billion, of the total lost earnings linked to smoking, followed by esophageal cancer (7%, or $1.5 billion), colorectal cancer (6%, or $1.2 billion), and liver cancer (5%, or $1.1 billion).

Smoking-related death rates were highest in the 13 “tobacco nation” states with weaker tobacco control policies and a higher rate of cigarette smoking. These states are Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia.

The lost earnings rate in all 13 tobacco nation states combined was about 44% higher, compared with other states and the District of Columbia combined, and the annual PYLL rate was 47% higher in tobacco nation states.

The researchers estimated that if PYLL and lost earnings rates in all states matched those in Utah, which has the lowest rates, more than half of the total PYLL and lost earnings nationally would have been avoided. In other words, that would mean 1.27 million PYLL and $10.5 billion saved in 2019.

Ending the ‘scourge of tobacco’

To kick the smoking habit, health providers should “screen patients for tobacco use, document tobacco use status, advise people who smoke to quit, and assist in attempts to quit,” Dr. Islami said.

Getting more people to screen for lung cancer in the United States is also important, given that only 6.6% of eligible people in 2019 received screening.

In a statement, Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said this report “further demonstrates just how critical reducing tobacco use is to ending suffering and death from cancer.”

To end the “scourge of tobacco,” local, state, and federal lawmakers need to pass proven tobacco control policies, she said.

These include regular and significant tobacco tax increases, thorough statewide smoke-free laws, and enough funding for state programs to prevent and stop smoking. It also means ensuring all Medicaid enrollees have access to all services that can help smokers quit as well as access to all FDA-approved medications that help users stop smoking.

“We have the tools to get this done, we just need lawmakers to act,” Ms. Lacasse said.

A version of this article first appeared on WebMD.com.

Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.

That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.

“During the past few decades, smoking has substantially declined in the U.S., followed by great declines in mortality from lung cancer and some other smoking-related cancers,” said lead author Farhad Islami, MD, senior scientific director of cancer disparity research at the American Cancer Society.

AtnoYdur/Thinkstock

Despite this “remarkable progress, our results indicate that smoking is still associated with about 30% of all cancer deaths and substantial lost earnings in the U.S., and that more work should be done to further reduce smoking in the country,” he said.

The study was published online in the International Journal of Cancer.

Dr. Islami and colleagues had found that lost earnings from cancer deaths in 2015 came to nearly $95 billion. Other research showed that a substantial portion of lost earnings from cancer deaths could be traced to cigarette smoking, but estimates were more than a decade old.

To provide more recent estimates and help guide tobacco control policies, Dr. Islami and colleagues estimated person-years of life lost (PYLL) and lost earnings from cigarette smoking-related cancer deaths in 2019.

Of the 418,563 cancer deaths in adults ages 25-79 years, an estimated 122,951 could be linked to cigarette smoking. That corresponds to 29.4% of all cancer deaths and roughly 2.2 million PYLL. Translated to lost earnings, the authors estimated $20.9 billion total, with average lost earnings of $170,000 per cancer death linked to smoking.

By cancer type, lung cancer accounted for about 62%, or $12.9 billion, of the total lost earnings linked to smoking, followed by esophageal cancer (7%, or $1.5 billion), colorectal cancer (6%, or $1.2 billion), and liver cancer (5%, or $1.1 billion).

Smoking-related death rates were highest in the 13 “tobacco nation” states with weaker tobacco control policies and a higher rate of cigarette smoking. These states are Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, and West Virginia.

The lost earnings rate in all 13 tobacco nation states combined was about 44% higher, compared with other states and the District of Columbia combined, and the annual PYLL rate was 47% higher in tobacco nation states.

The researchers estimated that if PYLL and lost earnings rates in all states matched those in Utah, which has the lowest rates, more than half of the total PYLL and lost earnings nationally would have been avoided. In other words, that would mean 1.27 million PYLL and $10.5 billion saved in 2019.

Ending the ‘scourge of tobacco’

To kick the smoking habit, health providers should “screen patients for tobacco use, document tobacco use status, advise people who smoke to quit, and assist in attempts to quit,” Dr. Islami said.

Getting more people to screen for lung cancer in the United States is also important, given that only 6.6% of eligible people in 2019 received screening.

In a statement, Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said this report “further demonstrates just how critical reducing tobacco use is to ending suffering and death from cancer.”

To end the “scourge of tobacco,” local, state, and federal lawmakers need to pass proven tobacco control policies, she said.

These include regular and significant tobacco tax increases, thorough statewide smoke-free laws, and enough funding for state programs to prevent and stop smoking. It also means ensuring all Medicaid enrollees have access to all services that can help smokers quit as well as access to all FDA-approved medications that help users stop smoking.

“We have the tools to get this done, we just need lawmakers to act,” Ms. Lacasse said.

A version of this article first appeared on WebMD.com.

Drinking tea has several reported health benefits, but most studies have been conducted in regions where green tea predominates. New data from Britain – where there is a strong tradition of ‘afternoon tea’ – now shows that black tea is also associated with health benefits.

The findings come from a prospective study of nearly 500,000 participants in the UK Biobank cohort, among whom drinking black tea was common. They suggest that drinking black tea may be associated with a moderately lower all-cause mortality risk, and the risk was lowest among those drinking two or more cups of tea per day.

The study was published online in Annals of Internal Medicine.

During a median follow-up of 11.2 years, those who drank at least two cups of tea each day had a lower all-cause mortality risk, reported Maki Inoue-Choi, PhD, and colleagues from the National Cancer Institute in Bethesda, Md.  

After multivariate adjustment, the hazard ratios for death among tea drinkers, compared with no tea intake, were similar across intake levels: 0.95 for daily intake of up to 1 cup, 0.87 for 2-3 cups, 0.88 for 4-5 cups, 0.88 for 6-7 cups, 0.91 for 8-9 cups, and 0.89 for 10 or more cups.

Drinking tea also showed an inverse association with mortality from cardiovascular disease (adjusted HRs ranging from 0.98 to 0.76), ischemic heart disease (aHRs ranging from 1.03 to 0.74), and stroke (aHRs ranging from 0.92 to 0.48 ), However, the researchers added that “no clear trend was seen for cancer or respiratory disease mortality, with associations among higher intake categories tending toward the null.”

There is “no clear answer” as to why no association was observed between tea consumption and cancer mortality in the current study, Dr. Inoue-Choi said at a press briefing. Notably, the effects were apparent regardless of whether milk or sugar was added to tea, tea temperature, or genetic variations in caffeine metabolism among participants.

She and her colleagues controlled for these factors, as well as numerous others that could confound the results, including coffee consumption and baseline health and demographic characteristics..

The study subjects were 498,043 adults with a mean baseline age of 56.5 years. About 85% reported drinking tea, 90% reported drinking black tea, and most drank two to three cups (29%), four to five cups (26%), or six to seven cups (12%) per day.

A limitation of the study is the lack of information on certain aspects of tea intake, such as portion size and tea strength, the authors noted.

Tea is among the most frequently consumed beverages worldwide, and studies from places where green tea is popular, like China and Japan, have demonstrated health benefits. Data from places where black tea is more commonly consumed have been lacking and have provided conflicting results, Dr. Inoue-Choi said.

 A presumed mechanism of action related to tea consumption is reduced oxidative stress and inflammation thanks to "polyphenols and flavonoids, namely catechins and their oxidated products," the authors explained. Oxidative stress and inflammation may promote carcinogenesis; therefore, reducing oxidative stress and inflammation may improve endothelial function, they added.

“While these findings may offer reassurance to tea drinkers, they do not indicate that people should start drinking tea or change their tea consumption for health benefits,” Dr. Inoue-Choi said, explaining that “the results need to be replicated in future studies and extended in other diverse populations.”

This study was funded by the National Cancer Institute Intramural Research Program and the NCI division of cancer epidemiology & genetics. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was updated 8/31/22.

Drinking tea has several reported health benefits, but most studies have been conducted in regions where green tea predominates. New data from Britain – where there is a strong tradition of ‘afternoon tea’ – now shows that black tea is also associated with health benefits.

The findings come from a prospective study of nearly 500,000 participants in the UK Biobank cohort, among whom drinking black tea was common. They suggest that drinking black tea may be associated with a moderately lower all-cause mortality risk, and the risk was lowest among those drinking two or more cups of tea per day.

The study was published online in Annals of Internal Medicine.

During a median follow-up of 11.2 years, those who drank at least two cups of tea each day had a lower all-cause mortality risk, reported Maki Inoue-Choi, PhD, and colleagues from the National Cancer Institute in Bethesda, Md.  

After multivariate adjustment, the hazard ratios for death among tea drinkers, compared with no tea intake, were similar across intake levels: 0.95 for daily intake of up to 1 cup, 0.87 for 2-3 cups, 0.88 for 4-5 cups, 0.88 for 6-7 cups, 0.91 for 8-9 cups, and 0.89 for 10 or more cups.

Drinking tea also showed an inverse association with mortality from cardiovascular disease (adjusted HRs ranging from 0.98 to 0.76), ischemic heart disease (aHRs ranging from 1.03 to 0.74), and stroke (aHRs ranging from 0.92 to 0.48 ), However, the researchers added that “no clear trend was seen for cancer or respiratory disease mortality, with associations among higher intake categories tending toward the null.”

There is “no clear answer” as to why no association was observed between tea consumption and cancer mortality in the current study, Dr. Inoue-Choi said at a press briefing. Notably, the effects were apparent regardless of whether milk or sugar was added to tea, tea temperature, or genetic variations in caffeine metabolism among participants.

She and her colleagues controlled for these factors, as well as numerous others that could confound the results, including coffee consumption and baseline health and demographic characteristics..

The study subjects were 498,043 adults with a mean baseline age of 56.5 years. About 85% reported drinking tea, 90% reported drinking black tea, and most drank two to three cups (29%), four to five cups (26%), or six to seven cups (12%) per day.

A limitation of the study is the lack of information on certain aspects of tea intake, such as portion size and tea strength, the authors noted.

Tea is among the most frequently consumed beverages worldwide, and studies from places where green tea is popular, like China and Japan, have demonstrated health benefits. Data from places where black tea is more commonly consumed have been lacking and have provided conflicting results, Dr. Inoue-Choi said.

 A presumed mechanism of action related to tea consumption is reduced oxidative stress and inflammation thanks to "polyphenols and flavonoids, namely catechins and their oxidated products," the authors explained. Oxidative stress and inflammation may promote carcinogenesis; therefore, reducing oxidative stress and inflammation may improve endothelial function, they added.

“While these findings may offer reassurance to tea drinkers, they do not indicate that people should start drinking tea or change their tea consumption for health benefits,” Dr. Inoue-Choi said, explaining that “the results need to be replicated in future studies and extended in other diverse populations.”

This study was funded by the National Cancer Institute Intramural Research Program and the NCI division of cancer epidemiology & genetics. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was updated 8/31/22.

Drinking tea has several reported health benefits, but most studies have been conducted in regions where green tea predominates. New data from Britain – where there is a strong tradition of ‘afternoon tea’ – now shows that black tea is also associated with health benefits.

The findings come from a prospective study of nearly 500,000 participants in the UK Biobank cohort, among whom drinking black tea was common. They suggest that drinking black tea may be associated with a moderately lower all-cause mortality risk, and the risk was lowest among those drinking two or more cups of tea per day.

The study was published online in Annals of Internal Medicine.

During a median follow-up of 11.2 years, those who drank at least two cups of tea each day had a lower all-cause mortality risk, reported Maki Inoue-Choi, PhD, and colleagues from the National Cancer Institute in Bethesda, Md.  

After multivariate adjustment, the hazard ratios for death among tea drinkers, compared with no tea intake, were similar across intake levels: 0.95 for daily intake of up to 1 cup, 0.87 for 2-3 cups, 0.88 for 4-5 cups, 0.88 for 6-7 cups, 0.91 for 8-9 cups, and 0.89 for 10 or more cups.

Drinking tea also showed an inverse association with mortality from cardiovascular disease (adjusted HRs ranging from 0.98 to 0.76), ischemic heart disease (aHRs ranging from 1.03 to 0.74), and stroke (aHRs ranging from 0.92 to 0.48 ), However, the researchers added that “no clear trend was seen for cancer or respiratory disease mortality, with associations among higher intake categories tending toward the null.”

There is “no clear answer” as to why no association was observed between tea consumption and cancer mortality in the current study, Dr. Inoue-Choi said at a press briefing. Notably, the effects were apparent regardless of whether milk or sugar was added to tea, tea temperature, or genetic variations in caffeine metabolism among participants.

She and her colleagues controlled for these factors, as well as numerous others that could confound the results, including coffee consumption and baseline health and demographic characteristics..

The study subjects were 498,043 adults with a mean baseline age of 56.5 years. About 85% reported drinking tea, 90% reported drinking black tea, and most drank two to three cups (29%), four to five cups (26%), or six to seven cups (12%) per day.

A limitation of the study is the lack of information on certain aspects of tea intake, such as portion size and tea strength, the authors noted.

Tea is among the most frequently consumed beverages worldwide, and studies from places where green tea is popular, like China and Japan, have demonstrated health benefits. Data from places where black tea is more commonly consumed have been lacking and have provided conflicting results, Dr. Inoue-Choi said.

 A presumed mechanism of action related to tea consumption is reduced oxidative stress and inflammation thanks to "polyphenols and flavonoids, namely catechins and their oxidated products," the authors explained. Oxidative stress and inflammation may promote carcinogenesis; therefore, reducing oxidative stress and inflammation may improve endothelial function, they added.

“While these findings may offer reassurance to tea drinkers, they do not indicate that people should start drinking tea or change their tea consumption for health benefits,” Dr. Inoue-Choi said, explaining that “the results need to be replicated in future studies and extended in other diverse populations.”

This study was funded by the National Cancer Institute Intramural Research Program and the NCI division of cancer epidemiology & genetics. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was updated 8/31/22.

Recently, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.

Individuals can order the test – CancerDetect Test for Oral & Throat Cancer – directly from its maker, Viome Life Sciences, for $399.

It is not covered by medical insurance, and is not approved by the Food and Drug Administration. The test is being marketed under the agency’s “laboratory developed test” rubric.

People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer. During a 15-minute telemedicine conference – included in the $399 cost – those who test positive are told to follow up with a secondary care center for a definitive diagnosis.

For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guruduth Banavar, PhD, Viome’s chief technology officer, told this news organization.

Dr. Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.

CancerDetect’s tagline is “test at home for peace of mind.” The test “brings unprecedented accuracy to early cancer detection and prevention,” the company said in a press release announcing the launch.

The test showed an overall specificity of 94% and sensitivity of 84.2%-90% for cancer in Viome’s  latest study, which is posted on medRxiv.org as a preprint. Banavar said it has been submitted to a top-tier medical journal.

Viome plans to market CancerDetect “in every possible way” to consumers, including social media, Dr. Banavar said. CancerDetect is not sold on Amazon at the moment, but the company sells another at-home test for gut microbiome plus cellular health on the website. 

As for outreach to the medical community, “we will start doing that with dentists first” and then eventually oncologists and other doctors, but “our primary target is to get out to the consumers themselves,” Dr. Banavar said.

Viome’s main goal is to help consumers be proactive regarding their health, he said.
 

An expert opinion

The marketing push means that sooner or later, oncologists will likely have to deal with a patient who tests positive on CancerDetect, so this news organization turned to numerous experts for their thoughts. None had heard about the test, but one responded with comments.

“I am happy to see industry working on strategies for the early detection of oral and throat cancers,” and CancerDetect has “potential,” said surgical oncologist Saral Mehra, MD, MBA, chief of head and neck surgery at Yale University, New Haven, Conn.

However, after reviewing the study posted on medRxiv, Dr. Mehra advised caution. He said he was concerned about false negative results leading to missed cancers and false positives leading to unnecessary anxiety and testing.

According to the medRxiv preprint, the test was developed and validated using saliva samples from 1,175 people 50 years or older as well as adults with a history of tobacco use. 

In the 230-sample validation cohort, CancerDetect correctly classified 18 out of 20 people with oral squamous cell carcinoma (OSCC) and 64/76 with oropharyngeal squamous cell carcinoma (OPSCC), yielding sensitivities of 90% and 84.2%, respectively. 

The test also correctly identified 126/134 people as cancer free, for a specificity of 94%.

Results were similar between early and late-stage disease, but mixed in subgroups. Among people younger than age 50, for instance, 4/4 (100%) with OSCC and 2/3 (66.7%) with OPSCC were correctly classified as positive. Among older people, 15/17 (88.2%) with OSCC and 62/73 (84.9%) with OPSCC were correctly classified

Commenting on the results, Dr. Mehra noted that “the power of the study, especially for subgroup analysis, was low,” and investigators “used both advanced-stage and early-stage cancer patients in the model, while the target population for this test is early stage. 

“The research needs to be tightened significantly on specific target populations, the models adjusted to really limit false negatives, and a plan [put in place] to act upon positive results,” he said.

Also, the ability of CancerDetect to pick up premalignant lesions – “the greatest value in a screening test” – is not clear, he added.

Viome’s Dr. Banavar said that CancerDetect is in its first iteration, and the test uses machine learning, so its diagnostic performance will improve with the ongoing addition of real-world data.

The company is organizing a pivotal trial to gain formal FDA approval, with results expected in a year and a half or so, he said.

Viome is pushing ahead with its RNA diagnosis technology for the entire range of alimentary canal cancers and disorders, including inflammatory bowel disease. The company has partnered with pharmaceutical companies, including GSK, for vaccines, Dr. Banavar said.  

Dr. Mehra reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recently, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.

Individuals can order the test – CancerDetect Test for Oral & Throat Cancer – directly from its maker, Viome Life Sciences, for $399.

It is not covered by medical insurance, and is not approved by the Food and Drug Administration. The test is being marketed under the agency’s “laboratory developed test” rubric.

People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer. During a 15-minute telemedicine conference – included in the $399 cost – those who test positive are told to follow up with a secondary care center for a definitive diagnosis.

For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guruduth Banavar, PhD, Viome’s chief technology officer, told this news organization.

Dr. Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.

CancerDetect’s tagline is “test at home for peace of mind.” The test “brings unprecedented accuracy to early cancer detection and prevention,” the company said in a press release announcing the launch.

The test showed an overall specificity of 94% and sensitivity of 84.2%-90% for cancer in Viome’s  latest study, which is posted on medRxiv.org as a preprint. Banavar said it has been submitted to a top-tier medical journal.

Viome plans to market CancerDetect “in every possible way” to consumers, including social media, Dr. Banavar said. CancerDetect is not sold on Amazon at the moment, but the company sells another at-home test for gut microbiome plus cellular health on the website. 

As for outreach to the medical community, “we will start doing that with dentists first” and then eventually oncologists and other doctors, but “our primary target is to get out to the consumers themselves,” Dr. Banavar said.

Viome’s main goal is to help consumers be proactive regarding their health, he said.
 

An expert opinion

The marketing push means that sooner or later, oncologists will likely have to deal with a patient who tests positive on CancerDetect, so this news organization turned to numerous experts for their thoughts. None had heard about the test, but one responded with comments.

“I am happy to see industry working on strategies for the early detection of oral and throat cancers,” and CancerDetect has “potential,” said surgical oncologist Saral Mehra, MD, MBA, chief of head and neck surgery at Yale University, New Haven, Conn.

However, after reviewing the study posted on medRxiv, Dr. Mehra advised caution. He said he was concerned about false negative results leading to missed cancers and false positives leading to unnecessary anxiety and testing.

According to the medRxiv preprint, the test was developed and validated using saliva samples from 1,175 people 50 years or older as well as adults with a history of tobacco use. 

In the 230-sample validation cohort, CancerDetect correctly classified 18 out of 20 people with oral squamous cell carcinoma (OSCC) and 64/76 with oropharyngeal squamous cell carcinoma (OPSCC), yielding sensitivities of 90% and 84.2%, respectively. 

The test also correctly identified 126/134 people as cancer free, for a specificity of 94%.

Results were similar between early and late-stage disease, but mixed in subgroups. Among people younger than age 50, for instance, 4/4 (100%) with OSCC and 2/3 (66.7%) with OPSCC were correctly classified as positive. Among older people, 15/17 (88.2%) with OSCC and 62/73 (84.9%) with OPSCC were correctly classified

Commenting on the results, Dr. Mehra noted that “the power of the study, especially for subgroup analysis, was low,” and investigators “used both advanced-stage and early-stage cancer patients in the model, while the target population for this test is early stage. 

“The research needs to be tightened significantly on specific target populations, the models adjusted to really limit false negatives, and a plan [put in place] to act upon positive results,” he said.

Also, the ability of CancerDetect to pick up premalignant lesions – “the greatest value in a screening test” – is not clear, he added.

Viome’s Dr. Banavar said that CancerDetect is in its first iteration, and the test uses machine learning, so its diagnostic performance will improve with the ongoing addition of real-world data.

The company is organizing a pivotal trial to gain formal FDA approval, with results expected in a year and a half or so, he said.

Viome is pushing ahead with its RNA diagnosis technology for the entire range of alimentary canal cancers and disorders, including inflammatory bowel disease. The company has partnered with pharmaceutical companies, including GSK, for vaccines, Dr. Banavar said.  

Dr. Mehra reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recently, a home test for oral and throat cancer was launched in the United States, and it is being marketed directly to the general public, aimed at former or current tobacco users and anyone 50 years or older.

Individuals can order the test – CancerDetect Test for Oral & Throat Cancer – directly from its maker, Viome Life Sciences, for $399.

It is not covered by medical insurance, and is not approved by the Food and Drug Administration. The test is being marketed under the agency’s “laboratory developed test” rubric.

People who qualify and buy the test are mailed a saliva collection tube, which they fill and mail back. The company then analyzes the RNA for changes in human cells and the oropharyngeal microbiome that are associated with cancer. During a 15-minute telemedicine conference – included in the $399 cost – those who test positive are told to follow up with a secondary care center for a definitive diagnosis.

For people who test positive but have no visible lesion to biopsy, doctors will likely opt for surveillance, computer scientist Guruduth Banavar, PhD, Viome’s chief technology officer, told this news organization.

Dr. Banavar said people have been buying the test every day since it was launched in early August, but he declined to give specific sales figures.

CancerDetect’s tagline is “test at home for peace of mind.” The test “brings unprecedented accuracy to early cancer detection and prevention,” the company said in a press release announcing the launch.

The test showed an overall specificity of 94% and sensitivity of 84.2%-90% for cancer in Viome’s  latest study, which is posted on medRxiv.org as a preprint. Banavar said it has been submitted to a top-tier medical journal.

Viome plans to market CancerDetect “in every possible way” to consumers, including social media, Dr. Banavar said. CancerDetect is not sold on Amazon at the moment, but the company sells another at-home test for gut microbiome plus cellular health on the website. 

As for outreach to the medical community, “we will start doing that with dentists first” and then eventually oncologists and other doctors, but “our primary target is to get out to the consumers themselves,” Dr. Banavar said.

Viome’s main goal is to help consumers be proactive regarding their health, he said.
 

An expert opinion

The marketing push means that sooner or later, oncologists will likely have to deal with a patient who tests positive on CancerDetect, so this news organization turned to numerous experts for their thoughts. None had heard about the test, but one responded with comments.

“I am happy to see industry working on strategies for the early detection of oral and throat cancers,” and CancerDetect has “potential,” said surgical oncologist Saral Mehra, MD, MBA, chief of head and neck surgery at Yale University, New Haven, Conn.

However, after reviewing the study posted on medRxiv, Dr. Mehra advised caution. He said he was concerned about false negative results leading to missed cancers and false positives leading to unnecessary anxiety and testing.

According to the medRxiv preprint, the test was developed and validated using saliva samples from 1,175 people 50 years or older as well as adults with a history of tobacco use. 

In the 230-sample validation cohort, CancerDetect correctly classified 18 out of 20 people with oral squamous cell carcinoma (OSCC) and 64/76 with oropharyngeal squamous cell carcinoma (OPSCC), yielding sensitivities of 90% and 84.2%, respectively. 

The test also correctly identified 126/134 people as cancer free, for a specificity of 94%.

Results were similar between early and late-stage disease, but mixed in subgroups. Among people younger than age 50, for instance, 4/4 (100%) with OSCC and 2/3 (66.7%) with OPSCC were correctly classified as positive. Among older people, 15/17 (88.2%) with OSCC and 62/73 (84.9%) with OPSCC were correctly classified

Commenting on the results, Dr. Mehra noted that “the power of the study, especially for subgroup analysis, was low,” and investigators “used both advanced-stage and early-stage cancer patients in the model, while the target population for this test is early stage. 

“The research needs to be tightened significantly on specific target populations, the models adjusted to really limit false negatives, and a plan [put in place] to act upon positive results,” he said.

Also, the ability of CancerDetect to pick up premalignant lesions – “the greatest value in a screening test” – is not clear, he added.

Viome’s Dr. Banavar said that CancerDetect is in its first iteration, and the test uses machine learning, so its diagnostic performance will improve with the ongoing addition of real-world data.

The company is organizing a pivotal trial to gain formal FDA approval, with results expected in a year and a half or so, he said.

Viome is pushing ahead with its RNA diagnosis technology for the entire range of alimentary canal cancers and disorders, including inflammatory bowel disease. The company has partnered with pharmaceutical companies, including GSK, for vaccines, Dr. Banavar said.  

Dr. Mehra reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clinical research in rheumatology was suffering from an identity crisis of sorts 40 years ago. A lack of consensus across continents resulted in differing views about clinical outcome measures and judgments about treatments.

Patients were not allowed to be the generating source of a clinical outcome, according to Peter Tugwell, MSc, MD. “The only outcomes that were acceptable were clinician assessments, blood tests, and imaging,” said Dr. Tugwell, professor of medicine, epidemiology, and public health at the University of Ottawa (Ont.) and a practicing rheumatologist at Ottawa Hospital.

Clinicians were coming to different conclusions about patient responses to treatment when managing rheumatoid arthritis in clinical practice.

OMERACT sought to address this lack of uniformity. This international group, formed in 1992, leverages stakeholder groups to improve outcome measurement in rheumatology endpoints through a consensus-building, data-driven format.

It was originally known as “Outcome Measures in Rheumatoid Arthritis Clinical Trials,” but its leaders have since broadened its scope to “Outcome Measures in Rheumatology.” Over the years, it has evolved into an international network that assesses measurement across a wide variety of intervention studies. Now 30 years old, the network spans 40 active working groups and has influenced work in patient outcomes across 500 peer-reviewed publications.

The network meets every 2 years to address what is always a challenging agenda, said Dr. Tugwell, one of its founding members and chair. “There’s lots of strong opinions.” Participating in the discussions are individuals from all stages of seniority in rheumatology and clinical epidemiology, patient research partners, industry, approval agencies, and many countries who are committed to the spirit of OMERACT.

“The secret to our success has been getting world leaders to come together and have those discussions, work them through, and identify common ground in such a way that the approval agencies accept these outcome measures in clinical trials,” he added.

“My impression was the founders perceived a problem in the early 1990s and devised a consensus method in an attempt to quantify clinical parameters to define disease activity in rheumatoid arthritis – an important first step to do clinical trials and allow comparisons between them,” said Patricia Woo, CBE, FMedSci, FRCP, emeritus professor of pediatric rheumatology and previous head of the Centre for Paediatric and Adolescent Rheumatology at UCL, London. At that time, even disease definitions varied between the United States and Europe and other parts of the world, said Dr. Woo, who is not a part of OMERACT. “This was especially true for pediatric rheumatology.”
 

Fusing the continental divide

OMERACT arose from a need to streamline clinical outcome measures in rheumatology. Research papers during the 1980s demonstrated a lack of coherence in managing patients with rheumatoid arthritis in routine practice. In addition, the measures used to define clinical endpoints in clinical trials operated in silos – they were either too specific to a certain trial, overlapped with other concepts, or didn’t reflect changes in treatment.

Approval agencies in Europe and North America were approving only outcomes measures developed by their respective researchers. This was also true of patients they tested on. “This seemed crazy,” Dr. Tugwell said.

Dr. Tugwell was involved in the Cochrane collaboration, which conducts systematic reviews of best evidence across the world that assesses the magnitude of benefits versus harms.

To achieve this goal, “you need to pull studies from around the world,” he said. Maarten Boers, MD, PhD, a rheumatologist (and later professor of clinical epidemiology at Amsterdam University Medical Center) from the Netherlands, spent a year in Ontario, Canada, to train as a clinical epidemiologist. Together, Dr. Tugwell and Dr. Boers began discussing options to develop more streamlined outcome measures.

Courtesy OMERACT

They initiated the first OMERACT conference in Maastricht, the Netherlands, in 1992. The Food and Drug Administration and European Medicines Agency participated, along with leaders of outcomes measurement in Europe and in North America.

Discussions centered on methods to develop outcomes in a meaningful fashion. During the first meeting, North American and European approval agencies agreed to accept each other’s studies and endpoints and patient reported outcomes.

Agreement was achieved on a preliminary set of outcome domains and measures that later became known as the WHO-ILAR (World Health Organization–International League of Associations for Rheumatology) core set. The set included seven outcome domains: tender joints, swollen joints, pain, physician global assessment, patient global assessment, physical disability, and acute phase reactants, and one additional outcome domain for studies lasting 1 year or more: radiographs of the joints.

“A proactive program was planned to test not only the validity of these endpoints, but also the methods for their measurement. This was the start of a continuing process,” OMERACT members said in a joint statement for this article. Meetings have since taken place every 2 years.

Courtesy OMERACT

OMERACT accomplishments

OMERACT now requires buy-in from four continents: Asia, Australia, Europe, and North America.

Its leaders have developed an explicit process for gaining endorsement of core outcome domains and instrument measurement sets. To fully capture the possibilities of “what to measure,” i.e., “measurable aspects of health conditions,” OMERACT has developed a framework of concepts, core areas, and outcome domains. The key concepts are pathophysiology (with a core area termed “manifestations/abnormalities”) and impact (with core areas of “death/lifespan,” and “life impact,” and the optional area of “societal/resource use”). An outcome domain defines an element of a core area to measure the effects of a treatment, such as blood markers, pain intensity, physical function, or emotional well-being.

A core outcome domain set is developed by agreeing to at least one outcome domain within one of the three core areas. Subsequently, a core outcome measurement set is developed by agreeing to at least one applicable measurement instrument for each core outcome domain. This requires documentation of validity, summarized under three metrics: truth, discrimination, and feasibility.

OMERACT’s handbook provides tutelage on establishing and implementing core outcomes, and several workbooks offer guidance on developing core outcome domain sets, selecting instruments for core outcome measurement sets, and OMERACT methodology.

All this work has led to widespread adoption.

Approval agencies have accepted OMERACT’s filter and methods advances, which have been adopted by many research groups in rheumatology and among nonrheumatology research groups. Organizations such as the U.S. National Institutes of Health’s National Institute of Neurological Disorders and Stroke have sought its advice.

Its core outcomes have been adopted and used for approval in the great majority of studies on rheumatoid arthritis, Dr. Tugwell said.

Several BMJ articles underscore the influence and uptake of OMERACT’s core outcome set. One 2017 paper, which analyzed 273 randomized trials of rheumatoid arthritis drug treatments on ClinicalTrials.gov, found that the WHO-ILAR arthritis core outcome set was reported in 81% of the studies. “The adoption of a core outcome set has the potential to increase consistency in outcomes measured across trials and ensure that trials are more likely to measure appropriate outcomes,” the authors concluded.

Since the initial 1992 meeting, OMERACT has broadened its focus from rheumatoid arthritis to 25 other musculoskeletal conditions.

For example, other OMERACT conferences have led to consensus on core sets of measures for osteoarthritis and osteoporosis, psoriasis/psoriatic arthritis, psychosocial measures, and a core set of data for cost-effectiveness evaluations.
 

‘Speed is a limitation’

OMERACT is a bottom-up volunteer organization. It doesn’t represent any official organization of any clinical society. “We’ve not asked to be adopted by the American College of Rheumatology, EULAR [European Alliance of Associations for Rheumatology], or other international organizations,” Dr. Tugwell said. It offers a chance for patients, users, and doers of research to work together to agree on rigorous criteria accepted by the approval agencies and take the necessary time to work things through.

This is not a fast process, usually taking 4-6 years to initiate and establish an outcome domain set, he emphasized. “It would be beneficial to do it faster if we had the resources to meet every year. The fact is we’re a volunteer organization that meets every 2 years.”

Speed is a limitation, he acknowledged, but it’s an acceptable trade-off for doing things correctly.

The group has faced other challenges during the COVID-19 pandemic, pivoting to a virtual format that had benefits and limitations.

In one respect, moving to a virtual meeting increased uptake in participation and voting, Dr. Tugwell said. Patient participants with severe rheumatoid arthritis no longer faced the challenges of travel. “On the other hand, we didn’t have the same opportunity to achieve common ground virtually,” he said. “Where there are strong disagreements, I’m a great believer that people need to know one another. There needs to be relationship building.”

OMERACT’s emerging leader program has been a cornerstone of its in-person meetings, engaging young rheumatologists to interact with some of the leaders of outcome measurement. The virtual format dampened this process somewhat, eliminating those important “café chats” between the stakeholders.

The hope is to bring people face-to-face once more at the next meeting in May 2023. The agenda will focus on relationship building, identifying controversial areas, and bringing younger people to develop relationships, Dr. Tugwell said. OMERACT will retain a virtual option for the worldwide voting, “which will allow for more buy-in from so many more people,” he added.
 

A consensus on pain

The onus of developing outcome measures that move with the times is sometimes too great for one group to manage. In 2018, OMERACT became a part of the Red Hat Group (RHG), an organization conceived at the COMET (Core Outcome Measures in Effectiveness Trials) VII meeting in Amsterdam.

RHG aims to improve the choice of outcomes in health research. It includes eight groups: COMET; OMERACT; the Cochrane Skin Core Outcome Set Initiative; Grading of Recommendations, Assessment, Development and Evaluations; Center for Medical Technology Policy; COnsensus-based Standards for the selection of health Measurement Instruments; Clinical Data Interchange Standards Consortium; and Standardized Outcomes in Nephrology.

The collaboration between groups offers a “very interesting interface between consensus building as well as hard evidence,” Dr. Tugwell said. The focus goes beyond rheumatology to other clinical areas of common interest, exploring how one classifies outcome domains in terms of symptoms, life impact, or death.

Pain is an important common denominator that the RHG has evaluated.

“We believe it’s too general. We’re trying to define pain across all Red Hat Groups because it’s clear that the research community has all these different scales for defining pain severity,” Dr. Tugwell said. “We have to find a way to make ruthless decisions and rules for doing it. And of course, it has to be transparent.”
 

Looking ahead

As part of its ongoing work, OMERACT is evaluating the robustness of instruments that rheumatologists use as outcome measures in clinical trials, which can be a laborious process. The OMERACT Filter 2.0, part of the latest iteration of the handbook, offers strong guidance for researchers but needs a long-term strategy and key methodological support. “To that end, we set up a technical advisory group to help people in the instrument selection work and that remains an ongoing process,” OMERACT leaders said in their joint statement.

OMERACT is looking at opportunities to create benchmark processes for developing core sets outside of rheumatology and a methodology around outcome measures such as contextual factors, composites, and surrogates.

It will also be taking a step back to solicit opinions from the approval agencies represented by the OMERACT membership on the OMERACT handbook.

The goal is to make sure the handbook aligns with everyone else’s approval and labeling requirements.
 

OMERACT’s patient participants bring important perspectives

OMERACT over the years has sought to become a more patient-centered group. Patients have been involved in OMERACT activities since its sixth meeting, forming an independent, yet integrated, group within the network. They have their own steering committee and produced and helped to update a glossary for OMERACT patients and professionals. 

Catherine (McGowan) Hofstetter, who was diagnosed with rheumatoid arthritis 30 years ago, chairs OMERACT’s Patient Research Partners Support Team. In a Q&A, she discussed the importance of patient voices and OMERACT’s plans to further educate and include patients in the dialogue on outcomes.

Question: Have patients always been a part of OMERACT meetings? 

Answer: Patients have been involved with OMERACT since 2002. The patient voice adds relevance to all the work that OMERACT does. You can’t begin to talk about outcomes unless there is a patient at the table with lived experience.

Q: Can you cite a few examples of how the patient voice enriches the conversation on outcomes research? 

A: Outcomes and priorities that are important to patients are often completely different than those of the clinician. For instance, a work outcome is important to someone who doesn’t have any medical insurance or disability insurance, so that you can ensure that there is food on the table and a roof over your head. Or it may be important to someone because the employment provides medical and disability insurance to provide security for them and their family. These are two different perspectives on work and therefore work priorities and outcomes.

Q: What have been some of the challenges of getting patients to participate?

A: Training patients is one challenge. OMERACT’s work has a very steep learning curve, and while the basics are the same between the groups in terms of looking at what we measure and how we measure it, the nuances of different working groups require a lot of time and energy to be comfortable enough with the work, and then be confident enough to bring your perspective and lived experience to the table. It’s also a very accomplished group, which can be quite intimidating. Self-disclosure is a very personal and intimate undertaking that requires patience, compassion, and respect.

Q: Are there any plans to enhance patient engagement?

A: When we had OMERACT 2020 it was a virtual conference that took place over about 6 months. We had far more patient research partners [PRPs] participate than we have ever had at any OMERACT face-to-face meeting. There is a desire and passion on the part of patients to lend their voices to the work. The working groups meet virtually throughout the year to advance their agendas, and PRPs are a part of each of the working groups. 

Hopefully, we can start working toward including more voices at the conferences by enabling a hybrid model. The PRP Support Team will begin engaging patients this fall with education, mentoring, and team-building exercises so by the time we meet in person in May 2023, they will have enough background knowledge and information to give them the confidence that will enhance their experience at the face-to-face meeting.

We also need to ensure that those patients who want to stay engaged can. This means that the education and training should continue long after the face-to-face meeting is over. We need to build capacity in the PRP group and look to succession planning and be a resource to working groups struggling to find PRPs to work with them on a longer-term basis.

Clinical research in rheumatology was suffering from an identity crisis of sorts 40 years ago. A lack of consensus across continents resulted in differing views about clinical outcome measures and judgments about treatments.

Patients were not allowed to be the generating source of a clinical outcome, according to Peter Tugwell, MSc, MD. “The only outcomes that were acceptable were clinician assessments, blood tests, and imaging,” said Dr. Tugwell, professor of medicine, epidemiology, and public health at the University of Ottawa (Ont.) and a practicing rheumatologist at Ottawa Hospital.

Clinicians were coming to different conclusions about patient responses to treatment when managing rheumatoid arthritis in clinical practice.

OMERACT sought to address this lack of uniformity. This international group, formed in 1992, leverages stakeholder groups to improve outcome measurement in rheumatology endpoints through a consensus-building, data-driven format.

It was originally known as “Outcome Measures in Rheumatoid Arthritis Clinical Trials,” but its leaders have since broadened its scope to “Outcome Measures in Rheumatology.” Over the years, it has evolved into an international network that assesses measurement across a wide variety of intervention studies. Now 30 years old, the network spans 40 active working groups and has influenced work in patient outcomes across 500 peer-reviewed publications.

The network meets every 2 years to address what is always a challenging agenda, said Dr. Tugwell, one of its founding members and chair. “There’s lots of strong opinions.” Participating in the discussions are individuals from all stages of seniority in rheumatology and clinical epidemiology, patient research partners, industry, approval agencies, and many countries who are committed to the spirit of OMERACT.

“The secret to our success has been getting world leaders to come together and have those discussions, work them through, and identify common ground in such a way that the approval agencies accept these outcome measures in clinical trials,” he added.

“My impression was the founders perceived a problem in the early 1990s and devised a consensus method in an attempt to quantify clinical parameters to define disease activity in rheumatoid arthritis – an important first step to do clinical trials and allow comparisons between them,” said Patricia Woo, CBE, FMedSci, FRCP, emeritus professor of pediatric rheumatology and previous head of the Centre for Paediatric and Adolescent Rheumatology at UCL, London. At that time, even disease definitions varied between the United States and Europe and other parts of the world, said Dr. Woo, who is not a part of OMERACT. “This was especially true for pediatric rheumatology.”
 

Fusing the continental divide

OMERACT arose from a need to streamline clinical outcome measures in rheumatology. Research papers during the 1980s demonstrated a lack of coherence in managing patients with rheumatoid arthritis in routine practice. In addition, the measures used to define clinical endpoints in clinical trials operated in silos – they were either too specific to a certain trial, overlapped with other concepts, or didn’t reflect changes in treatment.

Approval agencies in Europe and North America were approving only outcomes measures developed by their respective researchers. This was also true of patients they tested on. “This seemed crazy,” Dr. Tugwell said.

Dr. Tugwell was involved in the Cochrane collaboration, which conducts systematic reviews of best evidence across the world that assesses the magnitude of benefits versus harms.

To achieve this goal, “you need to pull studies from around the world,” he said. Maarten Boers, MD, PhD, a rheumatologist (and later professor of clinical epidemiology at Amsterdam University Medical Center) from the Netherlands, spent a year in Ontario, Canada, to train as a clinical epidemiologist. Together, Dr. Tugwell and Dr. Boers began discussing options to develop more streamlined outcome measures.

Courtesy OMERACT

They initiated the first OMERACT conference in Maastricht, the Netherlands, in 1992. The Food and Drug Administration and European Medicines Agency participated, along with leaders of outcomes measurement in Europe and in North America.

Discussions centered on methods to develop outcomes in a meaningful fashion. During the first meeting, North American and European approval agencies agreed to accept each other’s studies and endpoints and patient reported outcomes.

Agreement was achieved on a preliminary set of outcome domains and measures that later became known as the WHO-ILAR (World Health Organization–International League of Associations for Rheumatology) core set. The set included seven outcome domains: tender joints, swollen joints, pain, physician global assessment, patient global assessment, physical disability, and acute phase reactants, and one additional outcome domain for studies lasting 1 year or more: radiographs of the joints.

“A proactive program was planned to test not only the validity of these endpoints, but also the methods for their measurement. This was the start of a continuing process,” OMERACT members said in a joint statement for this article. Meetings have since taken place every 2 years.

Courtesy OMERACT

OMERACT accomplishments

OMERACT now requires buy-in from four continents: Asia, Australia, Europe, and North America.

Its leaders have developed an explicit process for gaining endorsement of core outcome domains and instrument measurement sets. To fully capture the possibilities of “what to measure,” i.e., “measurable aspects of health conditions,” OMERACT has developed a framework of concepts, core areas, and outcome domains. The key concepts are pathophysiology (with a core area termed “manifestations/abnormalities”) and impact (with core areas of “death/lifespan,” and “life impact,” and the optional area of “societal/resource use”). An outcome domain defines an element of a core area to measure the effects of a treatment, such as blood markers, pain intensity, physical function, or emotional well-being.

A core outcome domain set is developed by agreeing to at least one outcome domain within one of the three core areas. Subsequently, a core outcome measurement set is developed by agreeing to at least one applicable measurement instrument for each core outcome domain. This requires documentation of validity, summarized under three metrics: truth, discrimination, and feasibility.

OMERACT’s handbook provides tutelage on establishing and implementing core outcomes, and several workbooks offer guidance on developing core outcome domain sets, selecting instruments for core outcome measurement sets, and OMERACT methodology.

All this work has led to widespread adoption.

Approval agencies have accepted OMERACT’s filter and methods advances, which have been adopted by many research groups in rheumatology and among nonrheumatology research groups. Organizations such as the U.S. National Institutes of Health’s National Institute of Neurological Disorders and Stroke have sought its advice.

Its core outcomes have been adopted and used for approval in the great majority of studies on rheumatoid arthritis, Dr. Tugwell said.

Several BMJ articles underscore the influence and uptake of OMERACT’s core outcome set. One 2017 paper, which analyzed 273 randomized trials of rheumatoid arthritis drug treatments on ClinicalTrials.gov, found that the WHO-ILAR arthritis core outcome set was reported in 81% of the studies. “The adoption of a core outcome set has the potential to increase consistency in outcomes measured across trials and ensure that trials are more likely to measure appropriate outcomes,” the authors concluded.

Since the initial 1992 meeting, OMERACT has broadened its focus from rheumatoid arthritis to 25 other musculoskeletal conditions.

For example, other OMERACT conferences have led to consensus on core sets of measures for osteoarthritis and osteoporosis, psoriasis/psoriatic arthritis, psychosocial measures, and a core set of data for cost-effectiveness evaluations.
 

‘Speed is a limitation’

OMERACT is a bottom-up volunteer organization. It doesn’t represent any official organization of any clinical society. “We’ve not asked to be adopted by the American College of Rheumatology, EULAR [European Alliance of Associations for Rheumatology], or other international organizations,” Dr. Tugwell said. It offers a chance for patients, users, and doers of research to work together to agree on rigorous criteria accepted by the approval agencies and take the necessary time to work things through.

This is not a fast process, usually taking 4-6 years to initiate and establish an outcome domain set, he emphasized. “It would be beneficial to do it faster if we had the resources to meet every year. The fact is we’re a volunteer organization that meets every 2 years.”

Speed is a limitation, he acknowledged, but it’s an acceptable trade-off for doing things correctly.

The group has faced other challenges during the COVID-19 pandemic, pivoting to a virtual format that had benefits and limitations.

In one respect, moving to a virtual meeting increased uptake in participation and voting, Dr. Tugwell said. Patient participants with severe rheumatoid arthritis no longer faced the challenges of travel. “On the other hand, we didn’t have the same opportunity to achieve common ground virtually,” he said. “Where there are strong disagreements, I’m a great believer that people need to know one another. There needs to be relationship building.”

OMERACT’s emerging leader program has been a cornerstone of its in-person meetings, engaging young rheumatologists to interact with some of the leaders of outcome measurement. The virtual format dampened this process somewhat, eliminating those important “café chats” between the stakeholders.

The hope is to bring people face-to-face once more at the next meeting in May 2023. The agenda will focus on relationship building, identifying controversial areas, and bringing younger people to develop relationships, Dr. Tugwell said. OMERACT will retain a virtual option for the worldwide voting, “which will allow for more buy-in from so many more people,” he added.
 

A consensus on pain

The onus of developing outcome measures that move with the times is sometimes too great for one group to manage. In 2018, OMERACT became a part of the Red Hat Group (RHG), an organization conceived at the COMET (Core Outcome Measures in Effectiveness Trials) VII meeting in Amsterdam.

RHG aims to improve the choice of outcomes in health research. It includes eight groups: COMET; OMERACT; the Cochrane Skin Core Outcome Set Initiative; Grading of Recommendations, Assessment, Development and Evaluations; Center for Medical Technology Policy; COnsensus-based Standards for the selection of health Measurement Instruments; Clinical Data Interchange Standards Consortium; and Standardized Outcomes in Nephrology.

The collaboration between groups offers a “very interesting interface between consensus building as well as hard evidence,” Dr. Tugwell said. The focus goes beyond rheumatology to other clinical areas of common interest, exploring how one classifies outcome domains in terms of symptoms, life impact, or death.

Pain is an important common denominator that the RHG has evaluated.

“We believe it’s too general. We’re trying to define pain across all Red Hat Groups because it’s clear that the research community has all these different scales for defining pain severity,” Dr. Tugwell said. “We have to find a way to make ruthless decisions and rules for doing it. And of course, it has to be transparent.”
 

Looking ahead

As part of its ongoing work, OMERACT is evaluating the robustness of instruments that rheumatologists use as outcome measures in clinical trials, which can be a laborious process. The OMERACT Filter 2.0, part of the latest iteration of the handbook, offers strong guidance for researchers but needs a long-term strategy and key methodological support. “To that end, we set up a technical advisory group to help people in the instrument selection work and that remains an ongoing process,” OMERACT leaders said in their joint statement.

OMERACT is looking at opportunities to create benchmark processes for developing core sets outside of rheumatology and a methodology around outcome measures such as contextual factors, composites, and surrogates.

It will also be taking a step back to solicit opinions from the approval agencies represented by the OMERACT membership on the OMERACT handbook.

The goal is to make sure the handbook aligns with everyone else’s approval and labeling requirements.
 

OMERACT’s patient participants bring important perspectives

OMERACT over the years has sought to become a more patient-centered group. Patients have been involved in OMERACT activities since its sixth meeting, forming an independent, yet integrated, group within the network. They have their own steering committee and produced and helped to update a glossary for OMERACT patients and professionals. 

Catherine (McGowan) Hofstetter, who was diagnosed with rheumatoid arthritis 30 years ago, chairs OMERACT’s Patient Research Partners Support Team. In a Q&A, she discussed the importance of patient voices and OMERACT’s plans to further educate and include patients in the dialogue on outcomes.

Question: Have patients always been a part of OMERACT meetings? 

Answer: Patients have been involved with OMERACT since 2002. The patient voice adds relevance to all the work that OMERACT does. You can’t begin to talk about outcomes unless there is a patient at the table with lived experience.

Q: Can you cite a few examples of how the patient voice enriches the conversation on outcomes research? 

A: Outcomes and priorities that are important to patients are often completely different than those of the clinician. For instance, a work outcome is important to someone who doesn’t have any medical insurance or disability insurance, so that you can ensure that there is food on the table and a roof over your head. Or it may be important to someone because the employment provides medical and disability insurance to provide security for them and their family. These are two different perspectives on work and therefore work priorities and outcomes.

Q: What have been some of the challenges of getting patients to participate?

A: Training patients is one challenge. OMERACT’s work has a very steep learning curve, and while the basics are the same between the groups in terms of looking at what we measure and how we measure it, the nuances of different working groups require a lot of time and energy to be comfortable enough with the work, and then be confident enough to bring your perspective and lived experience to the table. It’s also a very accomplished group, which can be quite intimidating. Self-disclosure is a very personal and intimate undertaking that requires patience, compassion, and respect.

Q: Are there any plans to enhance patient engagement?

A: When we had OMERACT 2020 it was a virtual conference that took place over about 6 months. We had far more patient research partners [PRPs] participate than we have ever had at any OMERACT face-to-face meeting. There is a desire and passion on the part of patients to lend their voices to the work. The working groups meet virtually throughout the year to advance their agendas, and PRPs are a part of each of the working groups. 

Hopefully, we can start working toward including more voices at the conferences by enabling a hybrid model. The PRP Support Team will begin engaging patients this fall with education, mentoring, and team-building exercises so by the time we meet in person in May 2023, they will have enough background knowledge and information to give them the confidence that will enhance their experience at the face-to-face meeting.

We also need to ensure that those patients who want to stay engaged can. This means that the education and training should continue long after the face-to-face meeting is over. We need to build capacity in the PRP group and look to succession planning and be a resource to working groups struggling to find PRPs to work with them on a longer-term basis.

Clinical research in rheumatology was suffering from an identity crisis of sorts 40 years ago. A lack of consensus across continents resulted in differing views about clinical outcome measures and judgments about treatments.

Patients were not allowed to be the generating source of a clinical outcome, according to Peter Tugwell, MSc, MD. “The only outcomes that were acceptable were clinician assessments, blood tests, and imaging,” said Dr. Tugwell, professor of medicine, epidemiology, and public health at the University of Ottawa (Ont.) and a practicing rheumatologist at Ottawa Hospital.

Clinicians were coming to different conclusions about patient responses to treatment when managing rheumatoid arthritis in clinical practice.

OMERACT sought to address this lack of uniformity. This international group, formed in 1992, leverages stakeholder groups to improve outcome measurement in rheumatology endpoints through a consensus-building, data-driven format.

It was originally known as “Outcome Measures in Rheumatoid Arthritis Clinical Trials,” but its leaders have since broadened its scope to “Outcome Measures in Rheumatology.” Over the years, it has evolved into an international network that assesses measurement across a wide variety of intervention studies. Now 30 years old, the network spans 40 active working groups and has influenced work in patient outcomes across 500 peer-reviewed publications.

The network meets every 2 years to address what is always a challenging agenda, said Dr. Tugwell, one of its founding members and chair. “There’s lots of strong opinions.” Participating in the discussions are individuals from all stages of seniority in rheumatology and clinical epidemiology, patient research partners, industry, approval agencies, and many countries who are committed to the spirit of OMERACT.

“The secret to our success has been getting world leaders to come together and have those discussions, work them through, and identify common ground in such a way that the approval agencies accept these outcome measures in clinical trials,” he added.

“My impression was the founders perceived a problem in the early 1990s and devised a consensus method in an attempt to quantify clinical parameters to define disease activity in rheumatoid arthritis – an important first step to do clinical trials and allow comparisons between them,” said Patricia Woo, CBE, FMedSci, FRCP, emeritus professor of pediatric rheumatology and previous head of the Centre for Paediatric and Adolescent Rheumatology at UCL, London. At that time, even disease definitions varied between the United States and Europe and other parts of the world, said Dr. Woo, who is not a part of OMERACT. “This was especially true for pediatric rheumatology.”
 

Fusing the continental divide

OMERACT arose from a need to streamline clinical outcome measures in rheumatology. Research papers during the 1980s demonstrated a lack of coherence in managing patients with rheumatoid arthritis in routine practice. In addition, the measures used to define clinical endpoints in clinical trials operated in silos – they were either too specific to a certain trial, overlapped with other concepts, or didn’t reflect changes in treatment.

Approval agencies in Europe and North America were approving only outcomes measures developed by their respective researchers. This was also true of patients they tested on. “This seemed crazy,” Dr. Tugwell said.

Dr. Tugwell was involved in the Cochrane collaboration, which conducts systematic reviews of best evidence across the world that assesses the magnitude of benefits versus harms.

To achieve this goal, “you need to pull studies from around the world,” he said. Maarten Boers, MD, PhD, a rheumatologist (and later professor of clinical epidemiology at Amsterdam University Medical Center) from the Netherlands, spent a year in Ontario, Canada, to train as a clinical epidemiologist. Together, Dr. Tugwell and Dr. Boers began discussing options to develop more streamlined outcome measures.

Courtesy OMERACT

They initiated the first OMERACT conference in Maastricht, the Netherlands, in 1992. The Food and Drug Administration and European Medicines Agency participated, along with leaders of outcomes measurement in Europe and in North America.

Discussions centered on methods to develop outcomes in a meaningful fashion. During the first meeting, North American and European approval agencies agreed to accept each other’s studies and endpoints and patient reported outcomes.

Agreement was achieved on a preliminary set of outcome domains and measures that later became known as the WHO-ILAR (World Health Organization–International League of Associations for Rheumatology) core set. The set included seven outcome domains: tender joints, swollen joints, pain, physician global assessment, patient global assessment, physical disability, and acute phase reactants, and one additional outcome domain for studies lasting 1 year or more: radiographs of the joints.

“A proactive program was planned to test not only the validity of these endpoints, but also the methods for their measurement. This was the start of a continuing process,” OMERACT members said in a joint statement for this article. Meetings have since taken place every 2 years.

Courtesy OMERACT

OMERACT accomplishments

OMERACT now requires buy-in from four continents: Asia, Australia, Europe, and North America.

Its leaders have developed an explicit process for gaining endorsement of core outcome domains and instrument measurement sets. To fully capture the possibilities of “what to measure,” i.e., “measurable aspects of health conditions,” OMERACT has developed a framework of concepts, core areas, and outcome domains. The key concepts are pathophysiology (with a core area termed “manifestations/abnormalities”) and impact (with core areas of “death/lifespan,” and “life impact,” and the optional area of “societal/resource use”). An outcome domain defines an element of a core area to measure the effects of a treatment, such as blood markers, pain intensity, physical function, or emotional well-being.

A core outcome domain set is developed by agreeing to at least one outcome domain within one of the three core areas. Subsequently, a core outcome measurement set is developed by agreeing to at least one applicable measurement instrument for each core outcome domain. This requires documentation of validity, summarized under three metrics: truth, discrimination, and feasibility.

OMERACT’s handbook provides tutelage on establishing and implementing core outcomes, and several workbooks offer guidance on developing core outcome domain sets, selecting instruments for core outcome measurement sets, and OMERACT methodology.

All this work has led to widespread adoption.

Approval agencies have accepted OMERACT’s filter and methods advances, which have been adopted by many research groups in rheumatology and among nonrheumatology research groups. Organizations such as the U.S. National Institutes of Health’s National Institute of Neurological Disorders and Stroke have sought its advice.

Its core outcomes have been adopted and used for approval in the great majority of studies on rheumatoid arthritis, Dr. Tugwell said.

Several BMJ articles underscore the influence and uptake of OMERACT’s core outcome set. One 2017 paper, which analyzed 273 randomized trials of rheumatoid arthritis drug treatments on ClinicalTrials.gov, found that the WHO-ILAR arthritis core outcome set was reported in 81% of the studies. “The adoption of a core outcome set has the potential to increase consistency in outcomes measured across trials and ensure that trials are more likely to measure appropriate outcomes,” the authors concluded.

Since the initial 1992 meeting, OMERACT has broadened its focus from rheumatoid arthritis to 25 other musculoskeletal conditions.

For example, other OMERACT conferences have led to consensus on core sets of measures for osteoarthritis and osteoporosis, psoriasis/psoriatic arthritis, psychosocial measures, and a core set of data for cost-effectiveness evaluations.
 

‘Speed is a limitation’

OMERACT is a bottom-up volunteer organization. It doesn’t represent any official organization of any clinical society. “We’ve not asked to be adopted by the American College of Rheumatology, EULAR [European Alliance of Associations for Rheumatology], or other international organizations,” Dr. Tugwell said. It offers a chance for patients, users, and doers of research to work together to agree on rigorous criteria accepted by the approval agencies and take the necessary time to work things through.

This is not a fast process, usually taking 4-6 years to initiate and establish an outcome domain set, he emphasized. “It would be beneficial to do it faster if we had the resources to meet every year. The fact is we’re a volunteer organization that meets every 2 years.”

Speed is a limitation, he acknowledged, but it’s an acceptable trade-off for doing things correctly.

The group has faced other challenges during the COVID-19 pandemic, pivoting to a virtual format that had benefits and limitations.

In one respect, moving to a virtual meeting increased uptake in participation and voting, Dr. Tugwell said. Patient participants with severe rheumatoid arthritis no longer faced the challenges of travel. “On the other hand, we didn’t have the same opportunity to achieve common ground virtually,” he said. “Where there are strong disagreements, I’m a great believer that people need to know one another. There needs to be relationship building.”

OMERACT’s emerging leader program has been a cornerstone of its in-person meetings, engaging young rheumatologists to interact with some of the leaders of outcome measurement. The virtual format dampened this process somewhat, eliminating those important “café chats” between the stakeholders.

The hope is to bring people face-to-face once more at the next meeting in May 2023. The agenda will focus on relationship building, identifying controversial areas, and bringing younger people to develop relationships, Dr. Tugwell said. OMERACT will retain a virtual option for the worldwide voting, “which will allow for more buy-in from so many more people,” he added.
 

A consensus on pain

The onus of developing outcome measures that move with the times is sometimes too great for one group to manage. In 2018, OMERACT became a part of the Red Hat Group (RHG), an organization conceived at the COMET (Core Outcome Measures in Effectiveness Trials) VII meeting in Amsterdam.

RHG aims to improve the choice of outcomes in health research. It includes eight groups: COMET; OMERACT; the Cochrane Skin Core Outcome Set Initiative; Grading of Recommendations, Assessment, Development and Evaluations; Center for Medical Technology Policy; COnsensus-based Standards for the selection of health Measurement Instruments; Clinical Data Interchange Standards Consortium; and Standardized Outcomes in Nephrology.

The collaboration between groups offers a “very interesting interface between consensus building as well as hard evidence,” Dr. Tugwell said. The focus goes beyond rheumatology to other clinical areas of common interest, exploring how one classifies outcome domains in terms of symptoms, life impact, or death.

Pain is an important common denominator that the RHG has evaluated.

“We believe it’s too general. We’re trying to define pain across all Red Hat Groups because it’s clear that the research community has all these different scales for defining pain severity,” Dr. Tugwell said. “We have to find a way to make ruthless decisions and rules for doing it. And of course, it has to be transparent.”
 

Looking ahead

As part of its ongoing work, OMERACT is evaluating the robustness of instruments that rheumatologists use as outcome measures in clinical trials, which can be a laborious process. The OMERACT Filter 2.0, part of the latest iteration of the handbook, offers strong guidance for researchers but needs a long-term strategy and key methodological support. “To that end, we set up a technical advisory group to help people in the instrument selection work and that remains an ongoing process,” OMERACT leaders said in their joint statement.

OMERACT is looking at opportunities to create benchmark processes for developing core sets outside of rheumatology and a methodology around outcome measures such as contextual factors, composites, and surrogates.

It will also be taking a step back to solicit opinions from the approval agencies represented by the OMERACT membership on the OMERACT handbook.

The goal is to make sure the handbook aligns with everyone else’s approval and labeling requirements.
 

OMERACT’s patient participants bring important perspectives

OMERACT over the years has sought to become a more patient-centered group. Patients have been involved in OMERACT activities since its sixth meeting, forming an independent, yet integrated, group within the network. They have their own steering committee and produced and helped to update a glossary for OMERACT patients and professionals. 

Catherine (McGowan) Hofstetter, who was diagnosed with rheumatoid arthritis 30 years ago, chairs OMERACT’s Patient Research Partners Support Team. In a Q&A, she discussed the importance of patient voices and OMERACT’s plans to further educate and include patients in the dialogue on outcomes.

Question: Have patients always been a part of OMERACT meetings? 

Answer: Patients have been involved with OMERACT since 2002. The patient voice adds relevance to all the work that OMERACT does. You can’t begin to talk about outcomes unless there is a patient at the table with lived experience.

Q: Can you cite a few examples of how the patient voice enriches the conversation on outcomes research? 

A: Outcomes and priorities that are important to patients are often completely different than those of the clinician. For instance, a work outcome is important to someone who doesn’t have any medical insurance or disability insurance, so that you can ensure that there is food on the table and a roof over your head. Or it may be important to someone because the employment provides medical and disability insurance to provide security for them and their family. These are two different perspectives on work and therefore work priorities and outcomes.

Q: What have been some of the challenges of getting patients to participate?

A: Training patients is one challenge. OMERACT’s work has a very steep learning curve, and while the basics are the same between the groups in terms of looking at what we measure and how we measure it, the nuances of different working groups require a lot of time and energy to be comfortable enough with the work, and then be confident enough to bring your perspective and lived experience to the table. It’s also a very accomplished group, which can be quite intimidating. Self-disclosure is a very personal and intimate undertaking that requires patience, compassion, and respect.

Q: Are there any plans to enhance patient engagement?

A: When we had OMERACT 2020 it was a virtual conference that took place over about 6 months. We had far more patient research partners [PRPs] participate than we have ever had at any OMERACT face-to-face meeting. There is a desire and passion on the part of patients to lend their voices to the work. The working groups meet virtually throughout the year to advance their agendas, and PRPs are a part of each of the working groups. 

Hopefully, we can start working toward including more voices at the conferences by enabling a hybrid model. The PRP Support Team will begin engaging patients this fall with education, mentoring, and team-building exercises so by the time we meet in person in May 2023, they will have enough background knowledge and information to give them the confidence that will enhance their experience at the face-to-face meeting.

We also need to ensure that those patients who want to stay engaged can. This means that the education and training should continue long after the face-to-face meeting is over. We need to build capacity in the PRP group and look to succession planning and be a resource to working groups struggling to find PRPs to work with them on a longer-term basis.

Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.

COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.

These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.

In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).

A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).

Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.

“We can only speculate about the possible causes and effects of low SOST in COPD,” the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.

The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.

However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.

The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.

The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.

A version of this article first appeared on Medscape.com.

Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.

COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.

These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.

In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).

A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).

Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.

“We can only speculate about the possible causes and effects of low SOST in COPD,” the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.

The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.

However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.

The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.

The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.

A version of this article first appeared on Medscape.com.

Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.

COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.

These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.

In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).

A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).

Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.

“We can only speculate about the possible causes and effects of low SOST in COPD,” the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.

The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.

However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.

The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.

The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.

A version of this article first appeared on Medscape.com.

A new study suggests that oncologists can safely pull back on standard locoregional radiotherapy (RT) in select patients with cT1-2N1 breast cancer who are treated with primary chemotherapy prior to surgery. The key is to divide patients by risk level and treat them according to the study’s guidelines, the researchers reported.

“We think this study is a good step towards de-escalation, which should lead to equal survival chances but better quality of life,” lead study author Sabine de Wild, MD, a PhD student at Maastricht (the Netherlands) University Medical Center, said in an interview.

The study, published in The Lancet Oncology, was intended to provide insight into which breast cancer patients need adjuvant locoregional radiotherapy following postchemotherapy surgery, coauthor Liesbeth Boersma, MD, PhD, a radiation oncologist at Maastricht University Medical Center, said in an interview. “It is not yet known which of these patients would benefit from adjuvant locoregional radiotherapy and to what extent the response of the tumor to the chemotherapy should be taken into account.”

For the study, believed to be the first prospective analysis tackling this topic, researchers tracked 838 patients in The Netherlands who were treated for cT1-2N1 breast cancer with primary chemotherapy and surgery of the breast and axilla from 2011-2015. Tumors were less than 5 cm and metastases were one to three axillary nodes.

The subjects were divided into groups based on risk of locoregional recurrence, and each group underwent different therapies.

• Low-risk group: no metastases were present in the nodes (n = 291). “We omitted regional radiotherapy, and we omitted RT of the chest wall in case of a mastectomy. After breast conserving surgery, regular RT of the breast was recommended,” Dr. de Wild said.
• Intermediate-risk group, one to three metastases were still present (n = 370). “We omitted regional radiotherapy, but irradiated the chest wall or breast,” she said.
• High-risk group, three metastases were present (n = 177). “We did not de-escalate, and all patients were treated with locoregional RT,” she said.

According to the study, “the 5-year locoregional recurrence rate in all patients was 2.2% (95% confidence interval, 1.4-3.4). The 5-year locoregional recurrence rate was 2.1% (95% CI, 0.9-4.3) in the low-risk group, 2.2% (95% CI, 1.0-4.1) in the intermediate-risk group, and 2.3% (95% CI, 0.8-5.5) in the high-risk group.”

In 26% of cases, patients received more radiotherapy than the study guidelines suggested. “Remarkably,” the researchers wrote, “this did not seem to affect locoregional recurrence rate, recurrence­-free interval, and overall survival in a statistically significant or clinically relevant way.”

As for limitations, the authors noted that, “in each risk group, the actual sample size treated according to the study guideline was smaller than required based on the power calculation. Nevertheless, when performing the analyses in the subset of patients treated according to the study guideline, the upper limit of 95% CI of 5­-year locoregional recurrence rate did not exceed 7.8%.”

The study authors wrote that, “in the future, the results of this study might lead to more frequent omission of locoregional radiotherapy, which could result in lower morbidity and a better quality of life for patients with breast cancer who are receiving primary chemotherapy.”

However, Dr. de Wild said randomized trials are necessary “to investigate how treatment can be individualized further, i.e., by taking into account specific tumor characteristics.” Also, most patients in the study underwent axillary lymph node dissection, “while patients in daily practice may instead undergo targeted axillary dissection. Future studies are needed to determine if less radiotherapy is also safe in patients in whom axillary lymph node dissection is omitted.”

The study was funded by the Dutch Cancer Society. One coauthor reported a pending patent plus grants from AstraZeneca, Eurocept Plaza, Roche, Genentech, Gilead Sciences, Tesaro, Novartis, Dutch Cancer Society, ZonMw, and A Sister’s Hope; as well as consulting fees and other financial support from a variety of pharmaceutical companies. The other authors had no disclosures.

A new study suggests that oncologists can safely pull back on standard locoregional radiotherapy (RT) in select patients with cT1-2N1 breast cancer who are treated with primary chemotherapy prior to surgery. The key is to divide patients by risk level and treat them according to the study’s guidelines, the researchers reported.

“We think this study is a good step towards de-escalation, which should lead to equal survival chances but better quality of life,” lead study author Sabine de Wild, MD, a PhD student at Maastricht (the Netherlands) University Medical Center, said in an interview.

The study, published in The Lancet Oncology, was intended to provide insight into which breast cancer patients need adjuvant locoregional radiotherapy following postchemotherapy surgery, coauthor Liesbeth Boersma, MD, PhD, a radiation oncologist at Maastricht University Medical Center, said in an interview. “It is not yet known which of these patients would benefit from adjuvant locoregional radiotherapy and to what extent the response of the tumor to the chemotherapy should be taken into account.”

For the study, believed to be the first prospective analysis tackling this topic, researchers tracked 838 patients in The Netherlands who were treated for cT1-2N1 breast cancer with primary chemotherapy and surgery of the breast and axilla from 2011-2015. Tumors were less than 5 cm and metastases were one to three axillary nodes.

The subjects were divided into groups based on risk of locoregional recurrence, and each group underwent different therapies.

• Low-risk group: no metastases were present in the nodes (n = 291). “We omitted regional radiotherapy, and we omitted RT of the chest wall in case of a mastectomy. After breast conserving surgery, regular RT of the breast was recommended,” Dr. de Wild said.
• Intermediate-risk group, one to three metastases were still present (n = 370). “We omitted regional radiotherapy, but irradiated the chest wall or breast,” she said.
• High-risk group, three metastases were present (n = 177). “We did not de-escalate, and all patients were treated with locoregional RT,” she said.

According to the study, “the 5-year locoregional recurrence rate in all patients was 2.2% (95% confidence interval, 1.4-3.4). The 5-year locoregional recurrence rate was 2.1% (95% CI, 0.9-4.3) in the low-risk group, 2.2% (95% CI, 1.0-4.1) in the intermediate-risk group, and 2.3% (95% CI, 0.8-5.5) in the high-risk group.”

In 26% of cases, patients received more radiotherapy than the study guidelines suggested. “Remarkably,” the researchers wrote, “this did not seem to affect locoregional recurrence rate, recurrence­-free interval, and overall survival in a statistically significant or clinically relevant way.”

As for limitations, the authors noted that, “in each risk group, the actual sample size treated according to the study guideline was smaller than required based on the power calculation. Nevertheless, when performing the analyses in the subset of patients treated according to the study guideline, the upper limit of 95% CI of 5­-year locoregional recurrence rate did not exceed 7.8%.”

The study authors wrote that, “in the future, the results of this study might lead to more frequent omission of locoregional radiotherapy, which could result in lower morbidity and a better quality of life for patients with breast cancer who are receiving primary chemotherapy.”

However, Dr. de Wild said randomized trials are necessary “to investigate how treatment can be individualized further, i.e., by taking into account specific tumor characteristics.” Also, most patients in the study underwent axillary lymph node dissection, “while patients in daily practice may instead undergo targeted axillary dissection. Future studies are needed to determine if less radiotherapy is also safe in patients in whom axillary lymph node dissection is omitted.”

The study was funded by the Dutch Cancer Society. One coauthor reported a pending patent plus grants from AstraZeneca, Eurocept Plaza, Roche, Genentech, Gilead Sciences, Tesaro, Novartis, Dutch Cancer Society, ZonMw, and A Sister’s Hope; as well as consulting fees and other financial support from a variety of pharmaceutical companies. The other authors had no disclosures.

A new study suggests that oncologists can safely pull back on standard locoregional radiotherapy (RT) in select patients with cT1-2N1 breast cancer who are treated with primary chemotherapy prior to surgery. The key is to divide patients by risk level and treat them according to the study’s guidelines, the researchers reported.

“We think this study is a good step towards de-escalation, which should lead to equal survival chances but better quality of life,” lead study author Sabine de Wild, MD, a PhD student at Maastricht (the Netherlands) University Medical Center, said in an interview.

The study, published in The Lancet Oncology, was intended to provide insight into which breast cancer patients need adjuvant locoregional radiotherapy following postchemotherapy surgery, coauthor Liesbeth Boersma, MD, PhD, a radiation oncologist at Maastricht University Medical Center, said in an interview. “It is not yet known which of these patients would benefit from adjuvant locoregional radiotherapy and to what extent the response of the tumor to the chemotherapy should be taken into account.”

For the study, believed to be the first prospective analysis tackling this topic, researchers tracked 838 patients in The Netherlands who were treated for cT1-2N1 breast cancer with primary chemotherapy and surgery of the breast and axilla from 2011-2015. Tumors were less than 5 cm and metastases were one to three axillary nodes.

The subjects were divided into groups based on risk of locoregional recurrence, and each group underwent different therapies.

• Low-risk group: no metastases were present in the nodes (n = 291). “We omitted regional radiotherapy, and we omitted RT of the chest wall in case of a mastectomy. After breast conserving surgery, regular RT of the breast was recommended,” Dr. de Wild said.
• Intermediate-risk group, one to three metastases were still present (n = 370). “We omitted regional radiotherapy, but irradiated the chest wall or breast,” she said.
• High-risk group, three metastases were present (n = 177). “We did not de-escalate, and all patients were treated with locoregional RT,” she said.

According to the study, “the 5-year locoregional recurrence rate in all patients was 2.2% (95% confidence interval, 1.4-3.4). The 5-year locoregional recurrence rate was 2.1% (95% CI, 0.9-4.3) in the low-risk group, 2.2% (95% CI, 1.0-4.1) in the intermediate-risk group, and 2.3% (95% CI, 0.8-5.5) in the high-risk group.”

In 26% of cases, patients received more radiotherapy than the study guidelines suggested. “Remarkably,” the researchers wrote, “this did not seem to affect locoregional recurrence rate, recurrence­-free interval, and overall survival in a statistically significant or clinically relevant way.”

As for limitations, the authors noted that, “in each risk group, the actual sample size treated according to the study guideline was smaller than required based on the power calculation. Nevertheless, when performing the analyses in the subset of patients treated according to the study guideline, the upper limit of 95% CI of 5­-year locoregional recurrence rate did not exceed 7.8%.”

The study authors wrote that, “in the future, the results of this study might lead to more frequent omission of locoregional radiotherapy, which could result in lower morbidity and a better quality of life for patients with breast cancer who are receiving primary chemotherapy.”

However, Dr. de Wild said randomized trials are necessary “to investigate how treatment can be individualized further, i.e., by taking into account specific tumor characteristics.” Also, most patients in the study underwent axillary lymph node dissection, “while patients in daily practice may instead undergo targeted axillary dissection. Future studies are needed to determine if less radiotherapy is also safe in patients in whom axillary lymph node dissection is omitted.”

The study was funded by the Dutch Cancer Society. One coauthor reported a pending patent plus grants from AstraZeneca, Eurocept Plaza, Roche, Genentech, Gilead Sciences, Tesaro, Novartis, Dutch Cancer Society, ZonMw, and A Sister’s Hope; as well as consulting fees and other financial support from a variety of pharmaceutical companies. The other authors had no disclosures.