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Stool samples meet gastric biopsies for H. pylori antibiotic resistance testing
Using stool samples to test for Helicobacter pylori antibiotic resistance provides highly similar results to those of gastric biopsy samples, which suggests that stool testing may be a safer, more convenient, and more cost-effective option, according to investigators.
Head-to-head testing for resistance-associated mutations using next-generation sequencing (NGS) showed 92% concordance between the two sample types, with 100% technical success among polymerase chain reaction (PCR)–positive stool samples, lead author Steven Moss, MD, of Brown University, Providence, R.I., and colleagues reported.
“H. pylori eradication rates have declined largely due to rising antimicrobial resistance worldwide,” Dr. Moss said at the annual meeting of the American College of Gastroenterology. “There is therefore a need for rapid, accurate, reliable antibiotic resistance testing.”
According to Dr. Moss, molecular resistance testing of gastric biopsies yields similar results to culture-based testing of gastric biopsies, but endoscopic sample collection remains inconvenient and relatively costly, so “it is not commonly performed in many GI practices.
“Whether reliable resistance testing by NGS is possible from stool samples remains unclear,” Dr. Moss said.
To explore this possibility, Dr. Moss and colleagues recruited 262 patients scheduled for upper endoscopy at four sites in the United States. From each patient, two gastric biopsies were taken, and within 2 weeks of the procedure, prior to starting anti–H. pylori therapy, one stool sample was collected.
For gastric biopsy samples, H. pylori positivity was confirmed by PCR, whereas positivity in stool samples was confirmed by both fecal antigen testing and PCR. After confirmation, NGS was conducted, with screening for resistance-associated mutations to six commonly used antibiotics: clarithromycin, levofloxacin, metronidazole, tetracycline, amoxicillin, and rifabutin.
Out of 262 patients, 73 tested positive for H. pylori via stool testing; however, 2 of these patients had inadequate gastric DNA for analysis, leaving 71 patients in the evaluable dataset. Within this group, samples from 50 patients (70.4%) had at least one resistance-association mutation.
Among all 71 individuals, 65 patients (91.5%) had fully concordant results between the two sample types. In four out of the six discordant cases, there was only one difference in antibiotic-associated mutations. Concordance ranged from 89% for metronidazole mutations to 100% for tetracycline, amoxicillin, and rifabutin mutations.
“It is now possible to rapidly obtain susceptibility data without endoscopy,” Dr. Moss concluded. “Using NGS to determine H. pylori antibiotic resistance using stool obviates the cost, inconvenience, and risks of endoscopy resistance profiling.”
Dr. Moss noted that the cost of the stool-based test, through study sponsor American Molecular Laboratories, is about $450, and that the company is “working with various insurance companies to try to get [the test] reimbursed.”
For cases of H. pylori infection without resistance testing results, Dr. Moss recommended first-line treatment with quadruple bismuth–based therapy; however, he noted that “most gastroenterologists, in all kinds of practice, are not measuring their eradication success rate ... so it’s really difficult to know if your best guess is really the appropriate treatment.”
According to Lukasz Kwapisz, MD, of Baylor College of Medicine, Houston, the concordance results are “encouraging,” and suggest that stool-based testing “could be much easier for the patient and the clinician” to find ways to eradicate H. pylori infection.
Dr. Kwapisz predicted that it will take additional successful studies, as well as real-world data, to convert clinicians to the new approach. He suggested that the transition may be gradual, like the adoption of fecal calprotectin testing.
“I don’t know if it’s one singular defining study that will tell you: ‘Okay, we all have to use this [stool-based resistance testing],’ ” he said. “It kind of happens over time – over a 2- or 3-year stretch, I would think, with positive results.”
The study was supported by American Molecular Labs. The investigators disclosed additional relationships with Takeda, Phathom, and Redhill. Dr. Kwapisz reported no conflicts of interest.
Using stool samples to test for Helicobacter pylori antibiotic resistance provides highly similar results to those of gastric biopsy samples, which suggests that stool testing may be a safer, more convenient, and more cost-effective option, according to investigators.
Head-to-head testing for resistance-associated mutations using next-generation sequencing (NGS) showed 92% concordance between the two sample types, with 100% technical success among polymerase chain reaction (PCR)–positive stool samples, lead author Steven Moss, MD, of Brown University, Providence, R.I., and colleagues reported.
“H. pylori eradication rates have declined largely due to rising antimicrobial resistance worldwide,” Dr. Moss said at the annual meeting of the American College of Gastroenterology. “There is therefore a need for rapid, accurate, reliable antibiotic resistance testing.”
According to Dr. Moss, molecular resistance testing of gastric biopsies yields similar results to culture-based testing of gastric biopsies, but endoscopic sample collection remains inconvenient and relatively costly, so “it is not commonly performed in many GI practices.
“Whether reliable resistance testing by NGS is possible from stool samples remains unclear,” Dr. Moss said.
To explore this possibility, Dr. Moss and colleagues recruited 262 patients scheduled for upper endoscopy at four sites in the United States. From each patient, two gastric biopsies were taken, and within 2 weeks of the procedure, prior to starting anti–H. pylori therapy, one stool sample was collected.
For gastric biopsy samples, H. pylori positivity was confirmed by PCR, whereas positivity in stool samples was confirmed by both fecal antigen testing and PCR. After confirmation, NGS was conducted, with screening for resistance-associated mutations to six commonly used antibiotics: clarithromycin, levofloxacin, metronidazole, tetracycline, amoxicillin, and rifabutin.
Out of 262 patients, 73 tested positive for H. pylori via stool testing; however, 2 of these patients had inadequate gastric DNA for analysis, leaving 71 patients in the evaluable dataset. Within this group, samples from 50 patients (70.4%) had at least one resistance-association mutation.
Among all 71 individuals, 65 patients (91.5%) had fully concordant results between the two sample types. In four out of the six discordant cases, there was only one difference in antibiotic-associated mutations. Concordance ranged from 89% for metronidazole mutations to 100% for tetracycline, amoxicillin, and rifabutin mutations.
“It is now possible to rapidly obtain susceptibility data without endoscopy,” Dr. Moss concluded. “Using NGS to determine H. pylori antibiotic resistance using stool obviates the cost, inconvenience, and risks of endoscopy resistance profiling.”
Dr. Moss noted that the cost of the stool-based test, through study sponsor American Molecular Laboratories, is about $450, and that the company is “working with various insurance companies to try to get [the test] reimbursed.”
For cases of H. pylori infection without resistance testing results, Dr. Moss recommended first-line treatment with quadruple bismuth–based therapy; however, he noted that “most gastroenterologists, in all kinds of practice, are not measuring their eradication success rate ... so it’s really difficult to know if your best guess is really the appropriate treatment.”
According to Lukasz Kwapisz, MD, of Baylor College of Medicine, Houston, the concordance results are “encouraging,” and suggest that stool-based testing “could be much easier for the patient and the clinician” to find ways to eradicate H. pylori infection.
Dr. Kwapisz predicted that it will take additional successful studies, as well as real-world data, to convert clinicians to the new approach. He suggested that the transition may be gradual, like the adoption of fecal calprotectin testing.
“I don’t know if it’s one singular defining study that will tell you: ‘Okay, we all have to use this [stool-based resistance testing],’ ” he said. “It kind of happens over time – over a 2- or 3-year stretch, I would think, with positive results.”
The study was supported by American Molecular Labs. The investigators disclosed additional relationships with Takeda, Phathom, and Redhill. Dr. Kwapisz reported no conflicts of interest.
Using stool samples to test for Helicobacter pylori antibiotic resistance provides highly similar results to those of gastric biopsy samples, which suggests that stool testing may be a safer, more convenient, and more cost-effective option, according to investigators.
Head-to-head testing for resistance-associated mutations using next-generation sequencing (NGS) showed 92% concordance between the two sample types, with 100% technical success among polymerase chain reaction (PCR)–positive stool samples, lead author Steven Moss, MD, of Brown University, Providence, R.I., and colleagues reported.
“H. pylori eradication rates have declined largely due to rising antimicrobial resistance worldwide,” Dr. Moss said at the annual meeting of the American College of Gastroenterology. “There is therefore a need for rapid, accurate, reliable antibiotic resistance testing.”
According to Dr. Moss, molecular resistance testing of gastric biopsies yields similar results to culture-based testing of gastric biopsies, but endoscopic sample collection remains inconvenient and relatively costly, so “it is not commonly performed in many GI practices.
“Whether reliable resistance testing by NGS is possible from stool samples remains unclear,” Dr. Moss said.
To explore this possibility, Dr. Moss and colleagues recruited 262 patients scheduled for upper endoscopy at four sites in the United States. From each patient, two gastric biopsies were taken, and within 2 weeks of the procedure, prior to starting anti–H. pylori therapy, one stool sample was collected.
For gastric biopsy samples, H. pylori positivity was confirmed by PCR, whereas positivity in stool samples was confirmed by both fecal antigen testing and PCR. After confirmation, NGS was conducted, with screening for resistance-associated mutations to six commonly used antibiotics: clarithromycin, levofloxacin, metronidazole, tetracycline, amoxicillin, and rifabutin.
Out of 262 patients, 73 tested positive for H. pylori via stool testing; however, 2 of these patients had inadequate gastric DNA for analysis, leaving 71 patients in the evaluable dataset. Within this group, samples from 50 patients (70.4%) had at least one resistance-association mutation.
Among all 71 individuals, 65 patients (91.5%) had fully concordant results between the two sample types. In four out of the six discordant cases, there was only one difference in antibiotic-associated mutations. Concordance ranged from 89% for metronidazole mutations to 100% for tetracycline, amoxicillin, and rifabutin mutations.
“It is now possible to rapidly obtain susceptibility data without endoscopy,” Dr. Moss concluded. “Using NGS to determine H. pylori antibiotic resistance using stool obviates the cost, inconvenience, and risks of endoscopy resistance profiling.”
Dr. Moss noted that the cost of the stool-based test, through study sponsor American Molecular Laboratories, is about $450, and that the company is “working with various insurance companies to try to get [the test] reimbursed.”
For cases of H. pylori infection without resistance testing results, Dr. Moss recommended first-line treatment with quadruple bismuth–based therapy; however, he noted that “most gastroenterologists, in all kinds of practice, are not measuring their eradication success rate ... so it’s really difficult to know if your best guess is really the appropriate treatment.”
According to Lukasz Kwapisz, MD, of Baylor College of Medicine, Houston, the concordance results are “encouraging,” and suggest that stool-based testing “could be much easier for the patient and the clinician” to find ways to eradicate H. pylori infection.
Dr. Kwapisz predicted that it will take additional successful studies, as well as real-world data, to convert clinicians to the new approach. He suggested that the transition may be gradual, like the adoption of fecal calprotectin testing.
“I don’t know if it’s one singular defining study that will tell you: ‘Okay, we all have to use this [stool-based resistance testing],’ ” he said. “It kind of happens over time – over a 2- or 3-year stretch, I would think, with positive results.”
The study was supported by American Molecular Labs. The investigators disclosed additional relationships with Takeda, Phathom, and Redhill. Dr. Kwapisz reported no conflicts of interest.
FROM ACG 2021
Maryland reduces cesarean delivery rates
A statewide educational initiative in Maryland was associated with a significant reduction in cesarean delivery rates over 30 months, although program implementation was widely variable across participating hospitals, according to investigators.
Cesarean deliveries dropped 1.6% among nulliparous, term, singleton, vertex births, falling short of the 3.2% reduction recently achieved by a similar program in California, reported lead author Jennifer A. Callaghan-Koru, PhD, of the University of Maryland, Baltimore County, and colleagues.
“Although cesarean delivery can be lifesaving, evidence suggests that there is no benefit to maternal health when national cesarean delivery rates are higher than 20 per 100 live births,” the investigators wrote in Obstetrics & Gynecology.
They noted that cesarean delivery rates in the United States rose dramatically between 1996 and 2006, from 20.7% to 32.9%, before falling back to 31.7% in 2019.
According to the investigators, high cesarean delivery rates have drawn action from a roster of stakeholders, including the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), the Department of Health and Human Services, the Joint Commission, and the Council on Patient Safety in Women’s Health Care.
The latter group created an evidence-based obstetric patient safety bundle that was used in the present study. The investigators recruited 31 out of 32 birthing hospitals in Maryland, and over the course of 30 months, educated the participating hospitals on the practices recommended by the bundle, via in-person and remote training.
To measure implementation and associated outcomes, the investigators used a data portal provided by the ACOG Alliance for Innovation in Maternal Health (AIM) program, which supports adoption of the council’s safety bundle nationwide. Data included number of births; number of cesarean births; overall cesarean delivery rates; cesarean rates among nulliparous, term, singleton, vertex births; cesarean rates among nulliparous, term, singleton, vertex inductions; as well as severe maternal morbidity rates.
Among the 26 safety practices in the bundle, hospitals reported current use of 7 (median) before the program began, with a range from 0 to 23. During the 30-month collaboration, hospitals added a median of 4 practices, ranging from 0 to 17.
Concurrently, cesarean delivery rates for nulliparous, term, singleton, vertex births dropped from 26.9% to 28.5% (P = .011), while rates for inductions dropped to a greater degree, from 36.1% to 31.3% (P less than .001). Further analysis showed that greater reductions in rates of cesarean delivery were associated with adoption of practices in the “Response” domain.
“The Response domain has the largest number of practices that standardize clinical care, including induction scheduling, diagnosis and treatment of labor dystocia and failed induction, and interpretation of fetal heart rate patterns,” the investigators wrote. “The important role of standardizing care is consistent with a Cochrane review that found moderately strong evidence that the implementation of clinical practice guidelines, alongside feedback to clinicians (e.g., second opinions, audit and feedback of rates), can reduce cesarean delivery.”
Dr. Callaghan-Koru and colleagues noted the high variability of implementation among hospitals, which could explain why statewide reductions weren’t more dramatic.
“Other evaluations of perinatal quality improvement collaboratives have also found that some hospitals get left behind in these efforts, without making considerable progress and improving outcomes,” they wrote. “Given that work by state perinatal quality improvement collaboratives represents a primary national strategy for reducing maternal morbidity and mortality, it is critically important to conduct further implementation research to identify determinants of success and strategies to support all participating hospitals to make improvements.”
According to Iris Krishna, MD, of Emory University, Atlanta, each state’s starting point may predict how successful similar programs will be.
“The safe reduction in the cesarean delivery rate will vary by state,” Dr. Krishna said in a written comment. “States that have a well-established perinatal quality collaborative that have the support on the provider, hospital, and statewide level are more likely to successfully implement strategies and see a statistically significant decrease.”
She went on to emphasize the importance of collaboration across multiple levels of organization, and across a variety of health care providers and administrators.
“Successful implementation requires a multidisciplinary team (physicians, nurses, quality improvement officers) and a multifaceted approach (statewide policies),” Dr. Krishna said. “Key stakeholders will need to ‘buy in’ or be willing to support the policy and practice change to ensure its success. To address obstacles, initiatives to support vaginal birth are important, such as provider training on labor and support techniques, criteria for diagnosis of and management of labor dystocia and arrest disorders, standard responses to abnormal fetal heart rate patterns, and availability of expertise to lessen the need for cesarean delivery, such as breech version, instrumented delivery, and twin delivery protocols. It is also important for hospitals to a have a mentor model of quality improvement and shared learning strategies that work.”
Dr. Krishna agreed with the investigators that more work is necessary to determine best strategies for future intervention.
“Research is needed in identifying determinants of success and sustainment,” she said.
Dr. Burke received funding from her employer, Trinity Health, to conduct a pilot study concerning blood loss.
A statewide educational initiative in Maryland was associated with a significant reduction in cesarean delivery rates over 30 months, although program implementation was widely variable across participating hospitals, according to investigators.
Cesarean deliveries dropped 1.6% among nulliparous, term, singleton, vertex births, falling short of the 3.2% reduction recently achieved by a similar program in California, reported lead author Jennifer A. Callaghan-Koru, PhD, of the University of Maryland, Baltimore County, and colleagues.
“Although cesarean delivery can be lifesaving, evidence suggests that there is no benefit to maternal health when national cesarean delivery rates are higher than 20 per 100 live births,” the investigators wrote in Obstetrics & Gynecology.
They noted that cesarean delivery rates in the United States rose dramatically between 1996 and 2006, from 20.7% to 32.9%, before falling back to 31.7% in 2019.
According to the investigators, high cesarean delivery rates have drawn action from a roster of stakeholders, including the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), the Department of Health and Human Services, the Joint Commission, and the Council on Patient Safety in Women’s Health Care.
The latter group created an evidence-based obstetric patient safety bundle that was used in the present study. The investigators recruited 31 out of 32 birthing hospitals in Maryland, and over the course of 30 months, educated the participating hospitals on the practices recommended by the bundle, via in-person and remote training.
To measure implementation and associated outcomes, the investigators used a data portal provided by the ACOG Alliance for Innovation in Maternal Health (AIM) program, which supports adoption of the council’s safety bundle nationwide. Data included number of births; number of cesarean births; overall cesarean delivery rates; cesarean rates among nulliparous, term, singleton, vertex births; cesarean rates among nulliparous, term, singleton, vertex inductions; as well as severe maternal morbidity rates.
Among the 26 safety practices in the bundle, hospitals reported current use of 7 (median) before the program began, with a range from 0 to 23. During the 30-month collaboration, hospitals added a median of 4 practices, ranging from 0 to 17.
Concurrently, cesarean delivery rates for nulliparous, term, singleton, vertex births dropped from 26.9% to 28.5% (P = .011), while rates for inductions dropped to a greater degree, from 36.1% to 31.3% (P less than .001). Further analysis showed that greater reductions in rates of cesarean delivery were associated with adoption of practices in the “Response” domain.
“The Response domain has the largest number of practices that standardize clinical care, including induction scheduling, diagnosis and treatment of labor dystocia and failed induction, and interpretation of fetal heart rate patterns,” the investigators wrote. “The important role of standardizing care is consistent with a Cochrane review that found moderately strong evidence that the implementation of clinical practice guidelines, alongside feedback to clinicians (e.g., second opinions, audit and feedback of rates), can reduce cesarean delivery.”
Dr. Callaghan-Koru and colleagues noted the high variability of implementation among hospitals, which could explain why statewide reductions weren’t more dramatic.
“Other evaluations of perinatal quality improvement collaboratives have also found that some hospitals get left behind in these efforts, without making considerable progress and improving outcomes,” they wrote. “Given that work by state perinatal quality improvement collaboratives represents a primary national strategy for reducing maternal morbidity and mortality, it is critically important to conduct further implementation research to identify determinants of success and strategies to support all participating hospitals to make improvements.”
According to Iris Krishna, MD, of Emory University, Atlanta, each state’s starting point may predict how successful similar programs will be.
“The safe reduction in the cesarean delivery rate will vary by state,” Dr. Krishna said in a written comment. “States that have a well-established perinatal quality collaborative that have the support on the provider, hospital, and statewide level are more likely to successfully implement strategies and see a statistically significant decrease.”
She went on to emphasize the importance of collaboration across multiple levels of organization, and across a variety of health care providers and administrators.
“Successful implementation requires a multidisciplinary team (physicians, nurses, quality improvement officers) and a multifaceted approach (statewide policies),” Dr. Krishna said. “Key stakeholders will need to ‘buy in’ or be willing to support the policy and practice change to ensure its success. To address obstacles, initiatives to support vaginal birth are important, such as provider training on labor and support techniques, criteria for diagnosis of and management of labor dystocia and arrest disorders, standard responses to abnormal fetal heart rate patterns, and availability of expertise to lessen the need for cesarean delivery, such as breech version, instrumented delivery, and twin delivery protocols. It is also important for hospitals to a have a mentor model of quality improvement and shared learning strategies that work.”
Dr. Krishna agreed with the investigators that more work is necessary to determine best strategies for future intervention.
“Research is needed in identifying determinants of success and sustainment,” she said.
Dr. Burke received funding from her employer, Trinity Health, to conduct a pilot study concerning blood loss.
A statewide educational initiative in Maryland was associated with a significant reduction in cesarean delivery rates over 30 months, although program implementation was widely variable across participating hospitals, according to investigators.
Cesarean deliveries dropped 1.6% among nulliparous, term, singleton, vertex births, falling short of the 3.2% reduction recently achieved by a similar program in California, reported lead author Jennifer A. Callaghan-Koru, PhD, of the University of Maryland, Baltimore County, and colleagues.
“Although cesarean delivery can be lifesaving, evidence suggests that there is no benefit to maternal health when national cesarean delivery rates are higher than 20 per 100 live births,” the investigators wrote in Obstetrics & Gynecology.
They noted that cesarean delivery rates in the United States rose dramatically between 1996 and 2006, from 20.7% to 32.9%, before falling back to 31.7% in 2019.
According to the investigators, high cesarean delivery rates have drawn action from a roster of stakeholders, including the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), the Department of Health and Human Services, the Joint Commission, and the Council on Patient Safety in Women’s Health Care.
The latter group created an evidence-based obstetric patient safety bundle that was used in the present study. The investigators recruited 31 out of 32 birthing hospitals in Maryland, and over the course of 30 months, educated the participating hospitals on the practices recommended by the bundle, via in-person and remote training.
To measure implementation and associated outcomes, the investigators used a data portal provided by the ACOG Alliance for Innovation in Maternal Health (AIM) program, which supports adoption of the council’s safety bundle nationwide. Data included number of births; number of cesarean births; overall cesarean delivery rates; cesarean rates among nulliparous, term, singleton, vertex births; cesarean rates among nulliparous, term, singleton, vertex inductions; as well as severe maternal morbidity rates.
Among the 26 safety practices in the bundle, hospitals reported current use of 7 (median) before the program began, with a range from 0 to 23. During the 30-month collaboration, hospitals added a median of 4 practices, ranging from 0 to 17.
Concurrently, cesarean delivery rates for nulliparous, term, singleton, vertex births dropped from 26.9% to 28.5% (P = .011), while rates for inductions dropped to a greater degree, from 36.1% to 31.3% (P less than .001). Further analysis showed that greater reductions in rates of cesarean delivery were associated with adoption of practices in the “Response” domain.
“The Response domain has the largest number of practices that standardize clinical care, including induction scheduling, diagnosis and treatment of labor dystocia and failed induction, and interpretation of fetal heart rate patterns,” the investigators wrote. “The important role of standardizing care is consistent with a Cochrane review that found moderately strong evidence that the implementation of clinical practice guidelines, alongside feedback to clinicians (e.g., second opinions, audit and feedback of rates), can reduce cesarean delivery.”
Dr. Callaghan-Koru and colleagues noted the high variability of implementation among hospitals, which could explain why statewide reductions weren’t more dramatic.
“Other evaluations of perinatal quality improvement collaboratives have also found that some hospitals get left behind in these efforts, without making considerable progress and improving outcomes,” they wrote. “Given that work by state perinatal quality improvement collaboratives represents a primary national strategy for reducing maternal morbidity and mortality, it is critically important to conduct further implementation research to identify determinants of success and strategies to support all participating hospitals to make improvements.”
According to Iris Krishna, MD, of Emory University, Atlanta, each state’s starting point may predict how successful similar programs will be.
“The safe reduction in the cesarean delivery rate will vary by state,” Dr. Krishna said in a written comment. “States that have a well-established perinatal quality collaborative that have the support on the provider, hospital, and statewide level are more likely to successfully implement strategies and see a statistically significant decrease.”
She went on to emphasize the importance of collaboration across multiple levels of organization, and across a variety of health care providers and administrators.
“Successful implementation requires a multidisciplinary team (physicians, nurses, quality improvement officers) and a multifaceted approach (statewide policies),” Dr. Krishna said. “Key stakeholders will need to ‘buy in’ or be willing to support the policy and practice change to ensure its success. To address obstacles, initiatives to support vaginal birth are important, such as provider training on labor and support techniques, criteria for diagnosis of and management of labor dystocia and arrest disorders, standard responses to abnormal fetal heart rate patterns, and availability of expertise to lessen the need for cesarean delivery, such as breech version, instrumented delivery, and twin delivery protocols. It is also important for hospitals to a have a mentor model of quality improvement and shared learning strategies that work.”
Dr. Krishna agreed with the investigators that more work is necessary to determine best strategies for future intervention.
“Research is needed in identifying determinants of success and sustainment,” she said.
Dr. Burke received funding from her employer, Trinity Health, to conduct a pilot study concerning blood loss.
FROM OBSTETRICS & GYNECOLOGY
Step-wise medical therapy is cost effective for endometriosis
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
FROM OBSTETRICS & GYNECOLOGY
AGA Clinical Practice Update: Expert Review on IBD dysplasia surveillance, management
The American Gastroenterological Association recently published an expert review and clinical practice update addressing endoscopic surveillance and management of colorectal dysplasia in patients with inflammatory bowel disease (IBD).
Because of practice-altering advances in therapy and surveillance over the past 2 decades, an updated approach is needed, according to authors led by Sanjay K. Murthy, MD, of Ottawa Hospital Research Institute and Fernando Velayos, MD, from Kaiser Permanente San Francisco Medical Center.
“Not long ago, notions of imperceptible CRC [colorectal cancer] development and urgent need for colectomy in the face of dysplasia dominated IBD practice,” the authors wrote in Gastroenterology. “However, improvements in disease management, as well as endoscopic technology and quality, have dramatically changed the way in which we conceptualize and manage IBD-related dysplasia over the past 20 years.”
Most notably, the authors called for a more conservative approach to sample collection and intervention.
“The practices of taking nontargeted biopsies and of referring patients for colectomy in the setting of low-grade or invisible dysplasia are being increasingly challenged in favor of ‘smart’ approaches that emphasize careful inspection and targeted sampling of visible and subtle lesions using newer technologies ... as well as endoscopic management of most lesions that appear endoscopically resectable,” the authors wrote. “Indeed, surgery is being increasingly reserved for lesions harboring strong risk factors for invasive cancer or when endoscopic clearance is not possible.”
The 14 best practice advice statements cover a variety of topics, including appropriate lesion terminology and characterization, endoscopy timing, and indications for biopsies, resection, and colectomy.
“The proposed conceptual model and best practice advice statements in this review are best used in conjunction with evolving literature and existing societal guidelines as part of a shared decision-making process,” the authors noted.
Lesion descriptions
First, the authors provided best practice advice for retirement of three older terms: “dysplasia-associated lesion or mass, adenoma-like mass, and flat dysplasia.” Instead, they advised sorting precancerous colorectal lesions into one of three categories: nonpolypoid (less than 2.5 mm tall), polypoid (at least 2.5 mm tall), or invisible (if detected by nontargeted biopsy).
According to the update, lesion descriptions should also include location, morphology, size, presence of ulceration, clarity of borders, presence within an area of past or current colitis, use of special visualization techniques, and perceived completeness of resection.
Surveillance timing
All patients with chronic IBD should undergo colonoscopy screening for dysplasia 8-10 years after diagnosis, the authors wrote. Subsequent colonoscopies should be performed every 1-5 years, depending on risk factors, such as family history of colorectal cancer and quality of prior surveillance exams.
Higher-risk patients may require colonoscopies earlier and more frequently, according to the update. Patients diagnosed with primary sclerosing cholangitis, for instance, should undergo immediate colonoscopy, while patients at high risk of dysplasia (such as those with prior CRC) should undergo annual pouch surveillance.
General principles and surveillance colonoscopy
“Conditions and practices for dysplasia detection should be optimized,” the authors wrote, “including control of inflammation, use of high-definition endoscopes, bowel preparation, careful washing and inspection of all colorectal mucosa, and targeted sampling of any suspicious mucosal irregularities.”
Endoscopists should consider use of dye spray chromoendoscopy, “particularly if a standard definition endoscope is used or if there is a history of dysplasia,” the authors wrote. Alternatively, virtual chromoendoscopy may be used in conjunction with high-definition endoscopy.
Biopsy, resection, and colectomy
According to the update, if chromoendoscopy is used, then biopsies should be targeted “where mucosal findings are suspicious for dysplasia or are inexplicably different from the surrounding mucosa.”
If chromoendoscopy isn’t used, then the authors advised clinicians to also perform nontargeted biopsies, ideally four per 10 cm of colon, in addition to targeted biopsies of suspicious areas.
When lesions are clearly demarcated and lack submucosal fibrosis or stigmata of invasive cancer, then endoscopic resection is preferred over biopsy. Following resection, mucosal biopsies are usually unnecessary, “unless there are concerns about resection completeness.”
“If the resectability of a lesion is in question, referral to a specialized endoscopist or inflammatory bowel disease center is suggested,” wrote the authors.
They noted that, if visible dysplasia is truly unresectable or if invisible multifocal/high-grade dysplasia is encountered, then colectomy should be performed.
IBD control
Finally, the authors emphasized the importance of adequately managing IBD activity to reduce dysplasia risk.
“Because CRC risk in IBD is primarily driven by inflammation, and available data do not demonstrate a clear independent chemopreventive effect of available agents, the focus of chemoprevention in IBD should be control of inflammation,” they wrote.
The expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed no conflicts of interest.
The American Gastroenterological Association recently published an expert review and clinical practice update addressing endoscopic surveillance and management of colorectal dysplasia in patients with inflammatory bowel disease (IBD).
Because of practice-altering advances in therapy and surveillance over the past 2 decades, an updated approach is needed, according to authors led by Sanjay K. Murthy, MD, of Ottawa Hospital Research Institute and Fernando Velayos, MD, from Kaiser Permanente San Francisco Medical Center.
“Not long ago, notions of imperceptible CRC [colorectal cancer] development and urgent need for colectomy in the face of dysplasia dominated IBD practice,” the authors wrote in Gastroenterology. “However, improvements in disease management, as well as endoscopic technology and quality, have dramatically changed the way in which we conceptualize and manage IBD-related dysplasia over the past 20 years.”
Most notably, the authors called for a more conservative approach to sample collection and intervention.
“The practices of taking nontargeted biopsies and of referring patients for colectomy in the setting of low-grade or invisible dysplasia are being increasingly challenged in favor of ‘smart’ approaches that emphasize careful inspection and targeted sampling of visible and subtle lesions using newer technologies ... as well as endoscopic management of most lesions that appear endoscopically resectable,” the authors wrote. “Indeed, surgery is being increasingly reserved for lesions harboring strong risk factors for invasive cancer or when endoscopic clearance is not possible.”
The 14 best practice advice statements cover a variety of topics, including appropriate lesion terminology and characterization, endoscopy timing, and indications for biopsies, resection, and colectomy.
“The proposed conceptual model and best practice advice statements in this review are best used in conjunction with evolving literature and existing societal guidelines as part of a shared decision-making process,” the authors noted.
Lesion descriptions
First, the authors provided best practice advice for retirement of three older terms: “dysplasia-associated lesion or mass, adenoma-like mass, and flat dysplasia.” Instead, they advised sorting precancerous colorectal lesions into one of three categories: nonpolypoid (less than 2.5 mm tall), polypoid (at least 2.5 mm tall), or invisible (if detected by nontargeted biopsy).
According to the update, lesion descriptions should also include location, morphology, size, presence of ulceration, clarity of borders, presence within an area of past or current colitis, use of special visualization techniques, and perceived completeness of resection.
Surveillance timing
All patients with chronic IBD should undergo colonoscopy screening for dysplasia 8-10 years after diagnosis, the authors wrote. Subsequent colonoscopies should be performed every 1-5 years, depending on risk factors, such as family history of colorectal cancer and quality of prior surveillance exams.
Higher-risk patients may require colonoscopies earlier and more frequently, according to the update. Patients diagnosed with primary sclerosing cholangitis, for instance, should undergo immediate colonoscopy, while patients at high risk of dysplasia (such as those with prior CRC) should undergo annual pouch surveillance.
General principles and surveillance colonoscopy
“Conditions and practices for dysplasia detection should be optimized,” the authors wrote, “including control of inflammation, use of high-definition endoscopes, bowel preparation, careful washing and inspection of all colorectal mucosa, and targeted sampling of any suspicious mucosal irregularities.”
Endoscopists should consider use of dye spray chromoendoscopy, “particularly if a standard definition endoscope is used or if there is a history of dysplasia,” the authors wrote. Alternatively, virtual chromoendoscopy may be used in conjunction with high-definition endoscopy.
Biopsy, resection, and colectomy
According to the update, if chromoendoscopy is used, then biopsies should be targeted “where mucosal findings are suspicious for dysplasia or are inexplicably different from the surrounding mucosa.”
If chromoendoscopy isn’t used, then the authors advised clinicians to also perform nontargeted biopsies, ideally four per 10 cm of colon, in addition to targeted biopsies of suspicious areas.
When lesions are clearly demarcated and lack submucosal fibrosis or stigmata of invasive cancer, then endoscopic resection is preferred over biopsy. Following resection, mucosal biopsies are usually unnecessary, “unless there are concerns about resection completeness.”
“If the resectability of a lesion is in question, referral to a specialized endoscopist or inflammatory bowel disease center is suggested,” wrote the authors.
They noted that, if visible dysplasia is truly unresectable or if invisible multifocal/high-grade dysplasia is encountered, then colectomy should be performed.
IBD control
Finally, the authors emphasized the importance of adequately managing IBD activity to reduce dysplasia risk.
“Because CRC risk in IBD is primarily driven by inflammation, and available data do not demonstrate a clear independent chemopreventive effect of available agents, the focus of chemoprevention in IBD should be control of inflammation,” they wrote.
The expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed no conflicts of interest.
The American Gastroenterological Association recently published an expert review and clinical practice update addressing endoscopic surveillance and management of colorectal dysplasia in patients with inflammatory bowel disease (IBD).
Because of practice-altering advances in therapy and surveillance over the past 2 decades, an updated approach is needed, according to authors led by Sanjay K. Murthy, MD, of Ottawa Hospital Research Institute and Fernando Velayos, MD, from Kaiser Permanente San Francisco Medical Center.
“Not long ago, notions of imperceptible CRC [colorectal cancer] development and urgent need for colectomy in the face of dysplasia dominated IBD practice,” the authors wrote in Gastroenterology. “However, improvements in disease management, as well as endoscopic technology and quality, have dramatically changed the way in which we conceptualize and manage IBD-related dysplasia over the past 20 years.”
Most notably, the authors called for a more conservative approach to sample collection and intervention.
“The practices of taking nontargeted biopsies and of referring patients for colectomy in the setting of low-grade or invisible dysplasia are being increasingly challenged in favor of ‘smart’ approaches that emphasize careful inspection and targeted sampling of visible and subtle lesions using newer technologies ... as well as endoscopic management of most lesions that appear endoscopically resectable,” the authors wrote. “Indeed, surgery is being increasingly reserved for lesions harboring strong risk factors for invasive cancer or when endoscopic clearance is not possible.”
The 14 best practice advice statements cover a variety of topics, including appropriate lesion terminology and characterization, endoscopy timing, and indications for biopsies, resection, and colectomy.
“The proposed conceptual model and best practice advice statements in this review are best used in conjunction with evolving literature and existing societal guidelines as part of a shared decision-making process,” the authors noted.
Lesion descriptions
First, the authors provided best practice advice for retirement of three older terms: “dysplasia-associated lesion or mass, adenoma-like mass, and flat dysplasia.” Instead, they advised sorting precancerous colorectal lesions into one of three categories: nonpolypoid (less than 2.5 mm tall), polypoid (at least 2.5 mm tall), or invisible (if detected by nontargeted biopsy).
According to the update, lesion descriptions should also include location, morphology, size, presence of ulceration, clarity of borders, presence within an area of past or current colitis, use of special visualization techniques, and perceived completeness of resection.
Surveillance timing
All patients with chronic IBD should undergo colonoscopy screening for dysplasia 8-10 years after diagnosis, the authors wrote. Subsequent colonoscopies should be performed every 1-5 years, depending on risk factors, such as family history of colorectal cancer and quality of prior surveillance exams.
Higher-risk patients may require colonoscopies earlier and more frequently, according to the update. Patients diagnosed with primary sclerosing cholangitis, for instance, should undergo immediate colonoscopy, while patients at high risk of dysplasia (such as those with prior CRC) should undergo annual pouch surveillance.
General principles and surveillance colonoscopy
“Conditions and practices for dysplasia detection should be optimized,” the authors wrote, “including control of inflammation, use of high-definition endoscopes, bowel preparation, careful washing and inspection of all colorectal mucosa, and targeted sampling of any suspicious mucosal irregularities.”
Endoscopists should consider use of dye spray chromoendoscopy, “particularly if a standard definition endoscope is used or if there is a history of dysplasia,” the authors wrote. Alternatively, virtual chromoendoscopy may be used in conjunction with high-definition endoscopy.
Biopsy, resection, and colectomy
According to the update, if chromoendoscopy is used, then biopsies should be targeted “where mucosal findings are suspicious for dysplasia or are inexplicably different from the surrounding mucosa.”
If chromoendoscopy isn’t used, then the authors advised clinicians to also perform nontargeted biopsies, ideally four per 10 cm of colon, in addition to targeted biopsies of suspicious areas.
When lesions are clearly demarcated and lack submucosal fibrosis or stigmata of invasive cancer, then endoscopic resection is preferred over biopsy. Following resection, mucosal biopsies are usually unnecessary, “unless there are concerns about resection completeness.”
“If the resectability of a lesion is in question, referral to a specialized endoscopist or inflammatory bowel disease center is suggested,” wrote the authors.
They noted that, if visible dysplasia is truly unresectable or if invisible multifocal/high-grade dysplasia is encountered, then colectomy should be performed.
IBD control
Finally, the authors emphasized the importance of adequately managing IBD activity to reduce dysplasia risk.
“Because CRC risk in IBD is primarily driven by inflammation, and available data do not demonstrate a clear independent chemopreventive effect of available agents, the focus of chemoprevention in IBD should be control of inflammation,” they wrote.
The expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed no conflicts of interest.
FROM GASTROENTEROLOGY
Data supporting cannabis for childhood epilepsy remain scarce
, according to two leading experts.
In a recent invited review article, Martin Kirkpatrick, MD, of the University of Dundee (Scotland), and Finbar O’Callaghan, MD, PhD, of University College London suggested that childhood epilepsy may be easy terrain for commercial interests to break ground, and from there, build their presence.
“Children with epilepsy are at risk of being used as the ‘Trojan horse’ for the cannabis industry,” Dr. Kirkpatrick and Dr. O’Callaghan wrote in Developmental Medicine & Child Neurology.
They noted that some of the first publicized success stories involving cannabis oil for epilepsy coincided with the rise of the medicinal and recreational cannabis markets, which will constitute an estimated 55-billion-dollar industry by 2027.
“Pediatric neurologists, imbued with the need to practice evidence-based medicine and wary of prescribing unlicensed medicines that had inadequate safety data, suddenly found themselves at odds with an array of vested interests and, most unfortunately, with the families of patients who were keen to try anything that would alleviate the effects of their child’s seizures,” the investigators wrote.
According to the review, fundamental questions about cannabis remain unanswered, including concerns about safety with long-term use, and the medicinal value of various plant components, such as myrcene, a terpene that gives cannabis its characteristic smell.
“A widely discussed issue is whether the terpenes add any therapeutic benefit, contributing to the so-called entourage effect of ‘whole-plant’ medicines,” the investigators wrote. “The concept is that all the constituents of the plant together create ‘the sum of all the parts that leads to the magic or power of cannabis.’ Although commonly referred to, there is little or no robust evidence to support the entourage effect as a credible clinical concept.”
Clinical evidence for treatment of pediatric epilepsy is also lacking, according to Dr. Kirkpatrick and Dr. O’Callaghan.
“Unfortunately, apart from the studies of pure cannabidiol (CBD) in Lennox–Gastaut and Dravet syndromes and tuberous sclerosis complex, level I evidence in the field of CBMPs and refractory epilepsy is lacking,” they wrote.
While other experts have pointed out that lower-level evidence – such as patient-reported outcomes and observational data – have previously been sufficient for drug licensing, Dr. Kirkpatrick and Dr. O’Callaghan noted that such exceptions “almost always” involve conditions without any effective treatments, or drugs that are undeniably effective.
“This is not the scenario with CBMPs,” they wrote, referring to current clinical data as “low-level” evidence “suggesting … possible efficacy.”
They highlighted concerns about placebo effect with open-label epilepsy studies, citing a randomized controlled trial for Dravet syndrome, in which 27% of patients given placebo had a 50% reduction in seizure frequency.
“We need carefully designed, good-quality CBMP studies that produce results on which we can rely,” Dr. Kirkpatrick and Dr. O’Callaghan concluded. “We can then work with families to choose the best treatments for children and young people with epilepsy. We owe this to them.”
A therapy of last resort
Jerzy P. Szaflarski, MD, PhD, of the University of Alabama at Birmingham, agreed that data are lacking for the use of CBMPs with patients who have epilepsy and other neurologic conditions; however, he also suggested that Dr. Kirkpatrick and Dr. O’Callaghan did not provide adequate real-world clinical context.
“Medical cannabis is not used as a first-, second-, or third-line therapy,” Dr. Szaflarski said. “It’s mostly used as a last resort in the sense that patients have already failed multiple other therapies.” In that respect, patients and parents are desperate to try anything that might work. “We have medical cannabis, and our patients want to try it, and at the point when multiple therapies have failed, it’s a reasonable option.”
While Dr. Szaflarski agreed that more high-quality clinical trials are needed, he also noted the practical challenges involved in such trials, largely because of variations in cannabis plants.
“The content of the cannabis plant changes depending on the day that it’s collected and the exposure to sun and how much water it has and what’s in the soil and many other things,” Dr. Szaflarski said. “It’s hard to get a very good, standardized product, and that’s why there needs to be a good-quality product delivered by the industry, which I have not seen thus far.”
For this reason, Dr. Szaflarski steers parents and patients away from over-the-counter CBMPs and toward Epidiolex, the only FDA-approved form of CBD.
“There is evidence that Epidiolex works,” he said. “I don’t know whether the products that are sold in a local cannabis store have the same high purity as Epidiolex. I tell [parents] that we should try Epidiolex first because it’s the one that is approved. But if it doesn’t work, we can go in that [other] direction.”
For those going the commercial route, Dr. Szaflarski advised close attention to product ingredients, to ensure that CBMPs are “devoid of any impurities, pesticides, fungicides, and other products that could be potentially dangerous.”
Parents considering CBMPs for their children also need to weigh concerns about long-term neurological safety, he added, noting that, on one hand, commercial products lack data, while on the other, epilepsy itself may cause harm.
“They need to consider the potential effects [of CBMPs] on their child’s brain and development versus … the effects of seizures on the brain,” Dr. Szaflarski said.
Dr. Kirkpatrick and Dr. O’Callaghan disclosed an application for a National Institute for Health Research–funded randomized controlled trial on CBMPs and joint authorship of British Paediatric Neurology Association Guidance on the use of CBMPs in children and young people with epilepsy. Dr. Szaflarski disclosed a relationship with Greenwich Biosciences and several other cannabis companies.
, according to two leading experts.
In a recent invited review article, Martin Kirkpatrick, MD, of the University of Dundee (Scotland), and Finbar O’Callaghan, MD, PhD, of University College London suggested that childhood epilepsy may be easy terrain for commercial interests to break ground, and from there, build their presence.
“Children with epilepsy are at risk of being used as the ‘Trojan horse’ for the cannabis industry,” Dr. Kirkpatrick and Dr. O’Callaghan wrote in Developmental Medicine & Child Neurology.
They noted that some of the first publicized success stories involving cannabis oil for epilepsy coincided with the rise of the medicinal and recreational cannabis markets, which will constitute an estimated 55-billion-dollar industry by 2027.
“Pediatric neurologists, imbued with the need to practice evidence-based medicine and wary of prescribing unlicensed medicines that had inadequate safety data, suddenly found themselves at odds with an array of vested interests and, most unfortunately, with the families of patients who were keen to try anything that would alleviate the effects of their child’s seizures,” the investigators wrote.
According to the review, fundamental questions about cannabis remain unanswered, including concerns about safety with long-term use, and the medicinal value of various plant components, such as myrcene, a terpene that gives cannabis its characteristic smell.
“A widely discussed issue is whether the terpenes add any therapeutic benefit, contributing to the so-called entourage effect of ‘whole-plant’ medicines,” the investigators wrote. “The concept is that all the constituents of the plant together create ‘the sum of all the parts that leads to the magic or power of cannabis.’ Although commonly referred to, there is little or no robust evidence to support the entourage effect as a credible clinical concept.”
Clinical evidence for treatment of pediatric epilepsy is also lacking, according to Dr. Kirkpatrick and Dr. O’Callaghan.
“Unfortunately, apart from the studies of pure cannabidiol (CBD) in Lennox–Gastaut and Dravet syndromes and tuberous sclerosis complex, level I evidence in the field of CBMPs and refractory epilepsy is lacking,” they wrote.
While other experts have pointed out that lower-level evidence – such as patient-reported outcomes and observational data – have previously been sufficient for drug licensing, Dr. Kirkpatrick and Dr. O’Callaghan noted that such exceptions “almost always” involve conditions without any effective treatments, or drugs that are undeniably effective.
“This is not the scenario with CBMPs,” they wrote, referring to current clinical data as “low-level” evidence “suggesting … possible efficacy.”
They highlighted concerns about placebo effect with open-label epilepsy studies, citing a randomized controlled trial for Dravet syndrome, in which 27% of patients given placebo had a 50% reduction in seizure frequency.
“We need carefully designed, good-quality CBMP studies that produce results on which we can rely,” Dr. Kirkpatrick and Dr. O’Callaghan concluded. “We can then work with families to choose the best treatments for children and young people with epilepsy. We owe this to them.”
A therapy of last resort
Jerzy P. Szaflarski, MD, PhD, of the University of Alabama at Birmingham, agreed that data are lacking for the use of CBMPs with patients who have epilepsy and other neurologic conditions; however, he also suggested that Dr. Kirkpatrick and Dr. O’Callaghan did not provide adequate real-world clinical context.
“Medical cannabis is not used as a first-, second-, or third-line therapy,” Dr. Szaflarski said. “It’s mostly used as a last resort in the sense that patients have already failed multiple other therapies.” In that respect, patients and parents are desperate to try anything that might work. “We have medical cannabis, and our patients want to try it, and at the point when multiple therapies have failed, it’s a reasonable option.”
While Dr. Szaflarski agreed that more high-quality clinical trials are needed, he also noted the practical challenges involved in such trials, largely because of variations in cannabis plants.
“The content of the cannabis plant changes depending on the day that it’s collected and the exposure to sun and how much water it has and what’s in the soil and many other things,” Dr. Szaflarski said. “It’s hard to get a very good, standardized product, and that’s why there needs to be a good-quality product delivered by the industry, which I have not seen thus far.”
For this reason, Dr. Szaflarski steers parents and patients away from over-the-counter CBMPs and toward Epidiolex, the only FDA-approved form of CBD.
“There is evidence that Epidiolex works,” he said. “I don’t know whether the products that are sold in a local cannabis store have the same high purity as Epidiolex. I tell [parents] that we should try Epidiolex first because it’s the one that is approved. But if it doesn’t work, we can go in that [other] direction.”
For those going the commercial route, Dr. Szaflarski advised close attention to product ingredients, to ensure that CBMPs are “devoid of any impurities, pesticides, fungicides, and other products that could be potentially dangerous.”
Parents considering CBMPs for their children also need to weigh concerns about long-term neurological safety, he added, noting that, on one hand, commercial products lack data, while on the other, epilepsy itself may cause harm.
“They need to consider the potential effects [of CBMPs] on their child’s brain and development versus … the effects of seizures on the brain,” Dr. Szaflarski said.
Dr. Kirkpatrick and Dr. O’Callaghan disclosed an application for a National Institute for Health Research–funded randomized controlled trial on CBMPs and joint authorship of British Paediatric Neurology Association Guidance on the use of CBMPs in children and young people with epilepsy. Dr. Szaflarski disclosed a relationship with Greenwich Biosciences and several other cannabis companies.
, according to two leading experts.
In a recent invited review article, Martin Kirkpatrick, MD, of the University of Dundee (Scotland), and Finbar O’Callaghan, MD, PhD, of University College London suggested that childhood epilepsy may be easy terrain for commercial interests to break ground, and from there, build their presence.
“Children with epilepsy are at risk of being used as the ‘Trojan horse’ for the cannabis industry,” Dr. Kirkpatrick and Dr. O’Callaghan wrote in Developmental Medicine & Child Neurology.
They noted that some of the first publicized success stories involving cannabis oil for epilepsy coincided with the rise of the medicinal and recreational cannabis markets, which will constitute an estimated 55-billion-dollar industry by 2027.
“Pediatric neurologists, imbued with the need to practice evidence-based medicine and wary of prescribing unlicensed medicines that had inadequate safety data, suddenly found themselves at odds with an array of vested interests and, most unfortunately, with the families of patients who were keen to try anything that would alleviate the effects of their child’s seizures,” the investigators wrote.
According to the review, fundamental questions about cannabis remain unanswered, including concerns about safety with long-term use, and the medicinal value of various plant components, such as myrcene, a terpene that gives cannabis its characteristic smell.
“A widely discussed issue is whether the terpenes add any therapeutic benefit, contributing to the so-called entourage effect of ‘whole-plant’ medicines,” the investigators wrote. “The concept is that all the constituents of the plant together create ‘the sum of all the parts that leads to the magic or power of cannabis.’ Although commonly referred to, there is little or no robust evidence to support the entourage effect as a credible clinical concept.”
Clinical evidence for treatment of pediatric epilepsy is also lacking, according to Dr. Kirkpatrick and Dr. O’Callaghan.
“Unfortunately, apart from the studies of pure cannabidiol (CBD) in Lennox–Gastaut and Dravet syndromes and tuberous sclerosis complex, level I evidence in the field of CBMPs and refractory epilepsy is lacking,” they wrote.
While other experts have pointed out that lower-level evidence – such as patient-reported outcomes and observational data – have previously been sufficient for drug licensing, Dr. Kirkpatrick and Dr. O’Callaghan noted that such exceptions “almost always” involve conditions without any effective treatments, or drugs that are undeniably effective.
“This is not the scenario with CBMPs,” they wrote, referring to current clinical data as “low-level” evidence “suggesting … possible efficacy.”
They highlighted concerns about placebo effect with open-label epilepsy studies, citing a randomized controlled trial for Dravet syndrome, in which 27% of patients given placebo had a 50% reduction in seizure frequency.
“We need carefully designed, good-quality CBMP studies that produce results on which we can rely,” Dr. Kirkpatrick and Dr. O’Callaghan concluded. “We can then work with families to choose the best treatments for children and young people with epilepsy. We owe this to them.”
A therapy of last resort
Jerzy P. Szaflarski, MD, PhD, of the University of Alabama at Birmingham, agreed that data are lacking for the use of CBMPs with patients who have epilepsy and other neurologic conditions; however, he also suggested that Dr. Kirkpatrick and Dr. O’Callaghan did not provide adequate real-world clinical context.
“Medical cannabis is not used as a first-, second-, or third-line therapy,” Dr. Szaflarski said. “It’s mostly used as a last resort in the sense that patients have already failed multiple other therapies.” In that respect, patients and parents are desperate to try anything that might work. “We have medical cannabis, and our patients want to try it, and at the point when multiple therapies have failed, it’s a reasonable option.”
While Dr. Szaflarski agreed that more high-quality clinical trials are needed, he also noted the practical challenges involved in such trials, largely because of variations in cannabis plants.
“The content of the cannabis plant changes depending on the day that it’s collected and the exposure to sun and how much water it has and what’s in the soil and many other things,” Dr. Szaflarski said. “It’s hard to get a very good, standardized product, and that’s why there needs to be a good-quality product delivered by the industry, which I have not seen thus far.”
For this reason, Dr. Szaflarski steers parents and patients away from over-the-counter CBMPs and toward Epidiolex, the only FDA-approved form of CBD.
“There is evidence that Epidiolex works,” he said. “I don’t know whether the products that are sold in a local cannabis store have the same high purity as Epidiolex. I tell [parents] that we should try Epidiolex first because it’s the one that is approved. But if it doesn’t work, we can go in that [other] direction.”
For those going the commercial route, Dr. Szaflarski advised close attention to product ingredients, to ensure that CBMPs are “devoid of any impurities, pesticides, fungicides, and other products that could be potentially dangerous.”
Parents considering CBMPs for their children also need to weigh concerns about long-term neurological safety, he added, noting that, on one hand, commercial products lack data, while on the other, epilepsy itself may cause harm.
“They need to consider the potential effects [of CBMPs] on their child’s brain and development versus … the effects of seizures on the brain,” Dr. Szaflarski said.
Dr. Kirkpatrick and Dr. O’Callaghan disclosed an application for a National Institute for Health Research–funded randomized controlled trial on CBMPs and joint authorship of British Paediatric Neurology Association Guidance on the use of CBMPs in children and young people with epilepsy. Dr. Szaflarski disclosed a relationship with Greenwich Biosciences and several other cannabis companies.
FROM DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY
Atopic dermatitis subtype worsens into midlife, predicting poor health
giving reason to observe patients beyond the pediatric stage, according to a cohort study of more than 30,000 patients.
Early-life environmental factors, such as tobacco smoke exposure, were not reliable predictors of increasing AD into mid-adulthood, suggesting that a patient’s contemporaneous environment may impact disease course throughout life, reported lead author Katrina Abuabara, MD, associate professor of dermatology at the University of California, San Francisco, and colleagues.
“There is a lack of studies that prospectively examine the course of atopic eczema beyond adolescence/early adulthood, and a more comprehensive understanding of disease activity across the life span is needed,” the investigators wrote in JAMA Dermatology. “Data on long-term disease course may offer insight into mechanisms for disease onset and persistence, are important when counseling patients, and would establish baseline trajectories for future studies of whether new treatments can modify disease course and development of comorbidities.”
The present study included 30,905 patients from two population-based birth cohorts: the 1958 National Childhood Development Study (NCDS) and the 1970 British Cohort Study (BCS70). Follow-up data were collected between 1958 and 2016 via nine waves of standardized questionnaires, and subtypes of atopic eczema patterns were identified “based on parent-reported or self-reported atopic eczema period prevalence.”
This measure “was previously shown to coincide with standardized clinical examinations among children in the NCDS, and a similar questionnaire demonstrated high sensitivity and specificity for physician-diagnosed atopic eczema in U.S. populations,” the investigators noted.
Latent class analysis identified four disease subtypes based on probability of reporting prevalent AD into midlife: low (88%-91%), decreasing (4%), increasing (2%-6%), and persistently high (2%-3%) probability.
Next, the investigators looked for associations between these subtypes and established early-life risk factors, such as history of breastfeeding and childhood smoke exposure. None of the childhood environmental factors differentiated between high versus decreasing disease in adulthood, or increasing versus decreasing disease in adulthood. In contrast, female sex predicted the high versus decreasing adult subtype (odds ratio, 1.99; 95% confidence interval, 1.66-2.38), and the increasing versus decreasing adult subtype (OR, 1.99; 95% CI, 1.69-2.35).
These findings suggest that “disease trajectory is modifiable and may be influenced by environmental factors throughout life,” the investigators wrote.
Further analysis uncovered associations between adult AD subtypes and other health outcomes. For example, compared with adults in the low probability group, those in the high probability group were significantly more likely to report rhinitis (OR, 2.70; 95% CI, 2.24-3.26) and asthma (OR, 3.45; 95% CI, 2.82-4.21). Adults with the increasing subtype also had elevated rates of asthma and rhinitis, along with worse self-reported mental health at age 42 (OR, 1.45; 95% CI, 1.23-1.72) and poor general health at age 46/50 (OR, 1.29; 95% CI, 1.09-1.53).
“When extending the window of observation beyond childhood, clear subtypes of atopic eczema based on patterns of disease activity emerged,” the investigators concluded. “In particular, a newly identified subtype with increasing probability of activity in adulthood warrants additional attention given associations with poor self-reported physical and mental health in midlife.”
Commenting on these results, Robert Sidbury, MD, professor of dermatology at the University of Washington, Seattle, said that this is an “important study” because it adds to our understanding of natural disease course over time.
This knowledge, as a pediatric dermatologist, will help Dr. Sidbury answer one of the most common questions he hears from parents: When is it going to stop?
“Trying to put a little bit more evidence-based heft behind the answer ... is really important,” he said in an interview.
Based on available data, up to 10% of children with AD may have disease activity into adulthood, according to Dr. Sidbury, who is also chief of dermatology at Seattle Children’s Hospital.
“I would hazard to guess that most of those adults who have atopic dermatitis – at least the ones who had it in childhood – were told that they would grow out of it,” he said. “And so I think awareness is important – that [resolution with age] does not always happen.”
The findings also support the possibility that AD is a systemic disease, and that underlying immune dysregulation may be linked with serious health consequences later in life, Dr. Sidbury said, noting that “the stakes get higher and higher when you start speculating in that way.”
According to Dr. Sidbury, the reported link between childhood AD and poor midlife health raises questions about how modifiable the disease course may be, particularly in response to earlier intervention with emerging AD medications, which “seem to be much more effective and potent.”
“Will the advent of these medications and their adoption and use in treatment perhaps have a significant impact, not just on the prevention of atopic dermatitis itself, but maybe other comorbidities?” he asked.
For the time being, this question remains unanswered.
The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Wellcome Trust. Dr. Abuabara received grants from the National Institutes of Health during the study, as well as personal fees from Target RWE and Pfizer outside of this study. One author reported receiving NIH grants during the study, another reported receiving grants from the Wellcome Trust and the Innovative Medicine Initiative Horizon 2020 (BIOMAP project) during the study; there were no other disclosures. Dr. Sidbury disclosed relationships with Galderma, Regeneron, and Pfizer.
giving reason to observe patients beyond the pediatric stage, according to a cohort study of more than 30,000 patients.
Early-life environmental factors, such as tobacco smoke exposure, were not reliable predictors of increasing AD into mid-adulthood, suggesting that a patient’s contemporaneous environment may impact disease course throughout life, reported lead author Katrina Abuabara, MD, associate professor of dermatology at the University of California, San Francisco, and colleagues.
“There is a lack of studies that prospectively examine the course of atopic eczema beyond adolescence/early adulthood, and a more comprehensive understanding of disease activity across the life span is needed,” the investigators wrote in JAMA Dermatology. “Data on long-term disease course may offer insight into mechanisms for disease onset and persistence, are important when counseling patients, and would establish baseline trajectories for future studies of whether new treatments can modify disease course and development of comorbidities.”
The present study included 30,905 patients from two population-based birth cohorts: the 1958 National Childhood Development Study (NCDS) and the 1970 British Cohort Study (BCS70). Follow-up data were collected between 1958 and 2016 via nine waves of standardized questionnaires, and subtypes of atopic eczema patterns were identified “based on parent-reported or self-reported atopic eczema period prevalence.”
This measure “was previously shown to coincide with standardized clinical examinations among children in the NCDS, and a similar questionnaire demonstrated high sensitivity and specificity for physician-diagnosed atopic eczema in U.S. populations,” the investigators noted.
Latent class analysis identified four disease subtypes based on probability of reporting prevalent AD into midlife: low (88%-91%), decreasing (4%), increasing (2%-6%), and persistently high (2%-3%) probability.
Next, the investigators looked for associations between these subtypes and established early-life risk factors, such as history of breastfeeding and childhood smoke exposure. None of the childhood environmental factors differentiated between high versus decreasing disease in adulthood, or increasing versus decreasing disease in adulthood. In contrast, female sex predicted the high versus decreasing adult subtype (odds ratio, 1.99; 95% confidence interval, 1.66-2.38), and the increasing versus decreasing adult subtype (OR, 1.99; 95% CI, 1.69-2.35).
These findings suggest that “disease trajectory is modifiable and may be influenced by environmental factors throughout life,” the investigators wrote.
Further analysis uncovered associations between adult AD subtypes and other health outcomes. For example, compared with adults in the low probability group, those in the high probability group were significantly more likely to report rhinitis (OR, 2.70; 95% CI, 2.24-3.26) and asthma (OR, 3.45; 95% CI, 2.82-4.21). Adults with the increasing subtype also had elevated rates of asthma and rhinitis, along with worse self-reported mental health at age 42 (OR, 1.45; 95% CI, 1.23-1.72) and poor general health at age 46/50 (OR, 1.29; 95% CI, 1.09-1.53).
“When extending the window of observation beyond childhood, clear subtypes of atopic eczema based on patterns of disease activity emerged,” the investigators concluded. “In particular, a newly identified subtype with increasing probability of activity in adulthood warrants additional attention given associations with poor self-reported physical and mental health in midlife.”
Commenting on these results, Robert Sidbury, MD, professor of dermatology at the University of Washington, Seattle, said that this is an “important study” because it adds to our understanding of natural disease course over time.
This knowledge, as a pediatric dermatologist, will help Dr. Sidbury answer one of the most common questions he hears from parents: When is it going to stop?
“Trying to put a little bit more evidence-based heft behind the answer ... is really important,” he said in an interview.
Based on available data, up to 10% of children with AD may have disease activity into adulthood, according to Dr. Sidbury, who is also chief of dermatology at Seattle Children’s Hospital.
“I would hazard to guess that most of those adults who have atopic dermatitis – at least the ones who had it in childhood – were told that they would grow out of it,” he said. “And so I think awareness is important – that [resolution with age] does not always happen.”
The findings also support the possibility that AD is a systemic disease, and that underlying immune dysregulation may be linked with serious health consequences later in life, Dr. Sidbury said, noting that “the stakes get higher and higher when you start speculating in that way.”
According to Dr. Sidbury, the reported link between childhood AD and poor midlife health raises questions about how modifiable the disease course may be, particularly in response to earlier intervention with emerging AD medications, which “seem to be much more effective and potent.”
“Will the advent of these medications and their adoption and use in treatment perhaps have a significant impact, not just on the prevention of atopic dermatitis itself, but maybe other comorbidities?” he asked.
For the time being, this question remains unanswered.
The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Wellcome Trust. Dr. Abuabara received grants from the National Institutes of Health during the study, as well as personal fees from Target RWE and Pfizer outside of this study. One author reported receiving NIH grants during the study, another reported receiving grants from the Wellcome Trust and the Innovative Medicine Initiative Horizon 2020 (BIOMAP project) during the study; there were no other disclosures. Dr. Sidbury disclosed relationships with Galderma, Regeneron, and Pfizer.
giving reason to observe patients beyond the pediatric stage, according to a cohort study of more than 30,000 patients.
Early-life environmental factors, such as tobacco smoke exposure, were not reliable predictors of increasing AD into mid-adulthood, suggesting that a patient’s contemporaneous environment may impact disease course throughout life, reported lead author Katrina Abuabara, MD, associate professor of dermatology at the University of California, San Francisco, and colleagues.
“There is a lack of studies that prospectively examine the course of atopic eczema beyond adolescence/early adulthood, and a more comprehensive understanding of disease activity across the life span is needed,” the investigators wrote in JAMA Dermatology. “Data on long-term disease course may offer insight into mechanisms for disease onset and persistence, are important when counseling patients, and would establish baseline trajectories for future studies of whether new treatments can modify disease course and development of comorbidities.”
The present study included 30,905 patients from two population-based birth cohorts: the 1958 National Childhood Development Study (NCDS) and the 1970 British Cohort Study (BCS70). Follow-up data were collected between 1958 and 2016 via nine waves of standardized questionnaires, and subtypes of atopic eczema patterns were identified “based on parent-reported or self-reported atopic eczema period prevalence.”
This measure “was previously shown to coincide with standardized clinical examinations among children in the NCDS, and a similar questionnaire demonstrated high sensitivity and specificity for physician-diagnosed atopic eczema in U.S. populations,” the investigators noted.
Latent class analysis identified four disease subtypes based on probability of reporting prevalent AD into midlife: low (88%-91%), decreasing (4%), increasing (2%-6%), and persistently high (2%-3%) probability.
Next, the investigators looked for associations between these subtypes and established early-life risk factors, such as history of breastfeeding and childhood smoke exposure. None of the childhood environmental factors differentiated between high versus decreasing disease in adulthood, or increasing versus decreasing disease in adulthood. In contrast, female sex predicted the high versus decreasing adult subtype (odds ratio, 1.99; 95% confidence interval, 1.66-2.38), and the increasing versus decreasing adult subtype (OR, 1.99; 95% CI, 1.69-2.35).
These findings suggest that “disease trajectory is modifiable and may be influenced by environmental factors throughout life,” the investigators wrote.
Further analysis uncovered associations between adult AD subtypes and other health outcomes. For example, compared with adults in the low probability group, those in the high probability group were significantly more likely to report rhinitis (OR, 2.70; 95% CI, 2.24-3.26) and asthma (OR, 3.45; 95% CI, 2.82-4.21). Adults with the increasing subtype also had elevated rates of asthma and rhinitis, along with worse self-reported mental health at age 42 (OR, 1.45; 95% CI, 1.23-1.72) and poor general health at age 46/50 (OR, 1.29; 95% CI, 1.09-1.53).
“When extending the window of observation beyond childhood, clear subtypes of atopic eczema based on patterns of disease activity emerged,” the investigators concluded. “In particular, a newly identified subtype with increasing probability of activity in adulthood warrants additional attention given associations with poor self-reported physical and mental health in midlife.”
Commenting on these results, Robert Sidbury, MD, professor of dermatology at the University of Washington, Seattle, said that this is an “important study” because it adds to our understanding of natural disease course over time.
This knowledge, as a pediatric dermatologist, will help Dr. Sidbury answer one of the most common questions he hears from parents: When is it going to stop?
“Trying to put a little bit more evidence-based heft behind the answer ... is really important,” he said in an interview.
Based on available data, up to 10% of children with AD may have disease activity into adulthood, according to Dr. Sidbury, who is also chief of dermatology at Seattle Children’s Hospital.
“I would hazard to guess that most of those adults who have atopic dermatitis – at least the ones who had it in childhood – were told that they would grow out of it,” he said. “And so I think awareness is important – that [resolution with age] does not always happen.”
The findings also support the possibility that AD is a systemic disease, and that underlying immune dysregulation may be linked with serious health consequences later in life, Dr. Sidbury said, noting that “the stakes get higher and higher when you start speculating in that way.”
According to Dr. Sidbury, the reported link between childhood AD and poor midlife health raises questions about how modifiable the disease course may be, particularly in response to earlier intervention with emerging AD medications, which “seem to be much more effective and potent.”
“Will the advent of these medications and their adoption and use in treatment perhaps have a significant impact, not just on the prevention of atopic dermatitis itself, but maybe other comorbidities?” he asked.
For the time being, this question remains unanswered.
The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Wellcome Trust. Dr. Abuabara received grants from the National Institutes of Health during the study, as well as personal fees from Target RWE and Pfizer outside of this study. One author reported receiving NIH grants during the study, another reported receiving grants from the Wellcome Trust and the Innovative Medicine Initiative Horizon 2020 (BIOMAP project) during the study; there were no other disclosures. Dr. Sidbury disclosed relationships with Galderma, Regeneron, and Pfizer.
FROM JAMA DERMATOLOGY
Walking 7,000 steps per day may be enough to reduce mortality risk
based on prospective data from more than 2,000 people.
Findings were consistent regardless of race or sex, and step intensity had no impact on mortality risk, reported lead author Amanda E. Paluch, PhD, of the University of Massachusetts Amherst, and colleagues.
“In response to the need for empirical data on the associations of step volume and intensity with mortality in younger and diverse populations, we conducted a prospective study in middle-aged Black and White adults followed up for mortality for approximately 11 years,” the investigators wrote in JAMA Network Open. “The objectives of our study were to examine the associations of step volume and intensity with mortality overall and by race and sex.”
Steps per day is easy to communicate
Dr. Paluch noted that steps per day is a “very appealing metric to quantify activity,” for both researchers and laypeople.
“Steps per day is simple and easy to communicate in public health and clinical settings,” Dr. Paluch said in an interview. “Additionally, the dramatic growth of wearable devices measuring steps makes it appealing and broadens the reach of promoting physical activity to many individuals. Walking is an activity that most of the general population can pursue. It can also be accumulated throughout daily living and may seem more achievable to fit into busy lives than a structured exercise session.”
The present investigation was conducted as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study. The dataset included 2,110 participants ranging from 38-50 years of age, with a mean age of 45.2 years. A slightly higher proportion of the subjects were women (57.1%) and White (57.9%).
All participants wore an ActiGraph 7164 accelerometer for 1 week and were then followed for death of any cause, with a mean follow-up of 10.8 years. Multivariable-adjusted Cox proportional hazards models included a range of covariates, such as smoking history, body weight, alcohol intake, blood pressure, total cholesterol, and others. Step counts were grouped into low (less than 7,000 steps per day), moderate (7,000-9,999), and high (at least 10,000 steps per day) categories.
Compared with individuals who took less than 7,000 steps per day, those who took 7,000-9,000 steps per day had a 72% reduced risk of mortality (hazard ratio, 0.28; 95% confidence interval, 0.15-0.54). Going beyond 10,000 steps appeared to add no benefit, based on a 55% lower risk of all-cause mortality in the highly active group, compared with those taking less than 7,000 steps per day (HR, 0.45; 95% CI, 0.25-0.81).
Walking faster didn’t appear to help either, as stepping intensity was not associated with mortality risk; however, Dr. Paluch urged a cautious interpretation of this finding, calling it “inconclusive,” and suggesting that more research is needed.
“It is also important to note that this study only looked at premature all-cause mortality, and therefore the results may be different for other health outcomes, such as the risk of cardiovascular disease, or diabetes, cancer, or mental health outcomes,” Dr. Paluch said.
“The results from our study demonstrated that those who are least active have the most to gain,” Dr. Paluch said. “Even small incremental increases in steps per day are associated with a lower mortality risk during middle age. A walking plan that gradually works up toward 7,000-10,000 steps per day in middle-aged adults may have health benefits and lower the risk of premature mortality.”
Causality cannot be confirmed
According to Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), the study size, diverse population, and length of follow-up should increase confidence in the findings, although a causal relationship remains elusive.
“As this study is observational, causality between step count and mortality cannot be confirmed; however, the authors accounted for many factors, and the association was consistent in different analyses and with prior literature,” Dr. Joundi said in an interview. “The authors did not assess the risk of other important events like stroke and heart attack, and these could be addressed in a future study.”
Dr. Joundi, who recently published a study linking exercise with a 50% reduction in mortality after stroke, noted that “physical activity has innumerable benefits, and it’s important that people engage in activity that can be regular and consistent, regardless of the type or intensity.”
To this end, he highlighted the use of “devices capable of monitoring step count, which can be an important motivational tool,” and suggested that these findings may bring a sigh of relief to step counters who come up a little short on a common daily goal.
“A target of 10,000 steps is often used for public health promotion, and this study now provides convincing observational evidence that it may be an optimal step count target for mortality reduction,” Dr. Joundi said. “However, if 10,000 steps per day is not feasible, 7,000 steps seems to be a very reasonable target given its association with markedly lower mortality in this study.”
Not all step counters are equal
Unfortunately, such recommendations are complicated by uncertainty in measurement, as widely used step counting devices, like smart watches, may not yield the same results as research-grade accelerometers, according to Nicole L. Spartano, PhD, of Boston University.
“Many comparison studies have been conducted in laboratory settings among young healthy adults, but these do not necessarily reflect real-life wear experiences that will be generalizable to the population as a whole,” Dr. Spartano wrote in an accompanying editorial.
She called for large-scale comparison studies to compare research-grade and consumer devices.
“The reason for conducting comparison studies is not to develop distinct guidelines for different devices or subgroups of the population, but rather to understand the variability so that we can develop one clear message that is most appropriate to the public,” Dr. Spartano wrote. “Some devices may have bias in terms of step measurement at different activity intensity and may not record steps as accurately in older adults or individuals with obesity or mobility disorders. For example, when adults who were obese wore an ActiGraph monitor in a laboratory setting, the device only recorded 80% of steps walked at a moderate pace, while other devices recorded close to 100% of steps walked. If we in the public health community are to move toward using these devices more for physical activity prescription, these details will need to be explored in more depth.”
CARDIA was conducted and supported by the National Heart, Lung, and Blood Institute in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Some study authors received grants from the National Institutes of Health and the Kaiser Foundation Research Institute. Dr Spartano disclosed relationships with Novo Nordisk, the American Heart Association, the Alzheimer’s Association, and the National Institutes of Health. Dr. Joundi and Dr. Paluch disclosed no relevant financial relationships.
based on prospective data from more than 2,000 people.
Findings were consistent regardless of race or sex, and step intensity had no impact on mortality risk, reported lead author Amanda E. Paluch, PhD, of the University of Massachusetts Amherst, and colleagues.
“In response to the need for empirical data on the associations of step volume and intensity with mortality in younger and diverse populations, we conducted a prospective study in middle-aged Black and White adults followed up for mortality for approximately 11 years,” the investigators wrote in JAMA Network Open. “The objectives of our study were to examine the associations of step volume and intensity with mortality overall and by race and sex.”
Steps per day is easy to communicate
Dr. Paluch noted that steps per day is a “very appealing metric to quantify activity,” for both researchers and laypeople.
“Steps per day is simple and easy to communicate in public health and clinical settings,” Dr. Paluch said in an interview. “Additionally, the dramatic growth of wearable devices measuring steps makes it appealing and broadens the reach of promoting physical activity to many individuals. Walking is an activity that most of the general population can pursue. It can also be accumulated throughout daily living and may seem more achievable to fit into busy lives than a structured exercise session.”
The present investigation was conducted as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study. The dataset included 2,110 participants ranging from 38-50 years of age, with a mean age of 45.2 years. A slightly higher proportion of the subjects were women (57.1%) and White (57.9%).
All participants wore an ActiGraph 7164 accelerometer for 1 week and were then followed for death of any cause, with a mean follow-up of 10.8 years. Multivariable-adjusted Cox proportional hazards models included a range of covariates, such as smoking history, body weight, alcohol intake, blood pressure, total cholesterol, and others. Step counts were grouped into low (less than 7,000 steps per day), moderate (7,000-9,999), and high (at least 10,000 steps per day) categories.
Compared with individuals who took less than 7,000 steps per day, those who took 7,000-9,000 steps per day had a 72% reduced risk of mortality (hazard ratio, 0.28; 95% confidence interval, 0.15-0.54). Going beyond 10,000 steps appeared to add no benefit, based on a 55% lower risk of all-cause mortality in the highly active group, compared with those taking less than 7,000 steps per day (HR, 0.45; 95% CI, 0.25-0.81).
Walking faster didn’t appear to help either, as stepping intensity was not associated with mortality risk; however, Dr. Paluch urged a cautious interpretation of this finding, calling it “inconclusive,” and suggesting that more research is needed.
“It is also important to note that this study only looked at premature all-cause mortality, and therefore the results may be different for other health outcomes, such as the risk of cardiovascular disease, or diabetes, cancer, or mental health outcomes,” Dr. Paluch said.
“The results from our study demonstrated that those who are least active have the most to gain,” Dr. Paluch said. “Even small incremental increases in steps per day are associated with a lower mortality risk during middle age. A walking plan that gradually works up toward 7,000-10,000 steps per day in middle-aged adults may have health benefits and lower the risk of premature mortality.”
Causality cannot be confirmed
According to Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), the study size, diverse population, and length of follow-up should increase confidence in the findings, although a causal relationship remains elusive.
“As this study is observational, causality between step count and mortality cannot be confirmed; however, the authors accounted for many factors, and the association was consistent in different analyses and with prior literature,” Dr. Joundi said in an interview. “The authors did not assess the risk of other important events like stroke and heart attack, and these could be addressed in a future study.”
Dr. Joundi, who recently published a study linking exercise with a 50% reduction in mortality after stroke, noted that “physical activity has innumerable benefits, and it’s important that people engage in activity that can be regular and consistent, regardless of the type or intensity.”
To this end, he highlighted the use of “devices capable of monitoring step count, which can be an important motivational tool,” and suggested that these findings may bring a sigh of relief to step counters who come up a little short on a common daily goal.
“A target of 10,000 steps is often used for public health promotion, and this study now provides convincing observational evidence that it may be an optimal step count target for mortality reduction,” Dr. Joundi said. “However, if 10,000 steps per day is not feasible, 7,000 steps seems to be a very reasonable target given its association with markedly lower mortality in this study.”
Not all step counters are equal
Unfortunately, such recommendations are complicated by uncertainty in measurement, as widely used step counting devices, like smart watches, may not yield the same results as research-grade accelerometers, according to Nicole L. Spartano, PhD, of Boston University.
“Many comparison studies have been conducted in laboratory settings among young healthy adults, but these do not necessarily reflect real-life wear experiences that will be generalizable to the population as a whole,” Dr. Spartano wrote in an accompanying editorial.
She called for large-scale comparison studies to compare research-grade and consumer devices.
“The reason for conducting comparison studies is not to develop distinct guidelines for different devices or subgroups of the population, but rather to understand the variability so that we can develop one clear message that is most appropriate to the public,” Dr. Spartano wrote. “Some devices may have bias in terms of step measurement at different activity intensity and may not record steps as accurately in older adults or individuals with obesity or mobility disorders. For example, when adults who were obese wore an ActiGraph monitor in a laboratory setting, the device only recorded 80% of steps walked at a moderate pace, while other devices recorded close to 100% of steps walked. If we in the public health community are to move toward using these devices more for physical activity prescription, these details will need to be explored in more depth.”
CARDIA was conducted and supported by the National Heart, Lung, and Blood Institute in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Some study authors received grants from the National Institutes of Health and the Kaiser Foundation Research Institute. Dr Spartano disclosed relationships with Novo Nordisk, the American Heart Association, the Alzheimer’s Association, and the National Institutes of Health. Dr. Joundi and Dr. Paluch disclosed no relevant financial relationships.
based on prospective data from more than 2,000 people.
Findings were consistent regardless of race or sex, and step intensity had no impact on mortality risk, reported lead author Amanda E. Paluch, PhD, of the University of Massachusetts Amherst, and colleagues.
“In response to the need for empirical data on the associations of step volume and intensity with mortality in younger and diverse populations, we conducted a prospective study in middle-aged Black and White adults followed up for mortality for approximately 11 years,” the investigators wrote in JAMA Network Open. “The objectives of our study were to examine the associations of step volume and intensity with mortality overall and by race and sex.”
Steps per day is easy to communicate
Dr. Paluch noted that steps per day is a “very appealing metric to quantify activity,” for both researchers and laypeople.
“Steps per day is simple and easy to communicate in public health and clinical settings,” Dr. Paluch said in an interview. “Additionally, the dramatic growth of wearable devices measuring steps makes it appealing and broadens the reach of promoting physical activity to many individuals. Walking is an activity that most of the general population can pursue. It can also be accumulated throughout daily living and may seem more achievable to fit into busy lives than a structured exercise session.”
The present investigation was conducted as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study. The dataset included 2,110 participants ranging from 38-50 years of age, with a mean age of 45.2 years. A slightly higher proportion of the subjects were women (57.1%) and White (57.9%).
All participants wore an ActiGraph 7164 accelerometer for 1 week and were then followed for death of any cause, with a mean follow-up of 10.8 years. Multivariable-adjusted Cox proportional hazards models included a range of covariates, such as smoking history, body weight, alcohol intake, blood pressure, total cholesterol, and others. Step counts were grouped into low (less than 7,000 steps per day), moderate (7,000-9,999), and high (at least 10,000 steps per day) categories.
Compared with individuals who took less than 7,000 steps per day, those who took 7,000-9,000 steps per day had a 72% reduced risk of mortality (hazard ratio, 0.28; 95% confidence interval, 0.15-0.54). Going beyond 10,000 steps appeared to add no benefit, based on a 55% lower risk of all-cause mortality in the highly active group, compared with those taking less than 7,000 steps per day (HR, 0.45; 95% CI, 0.25-0.81).
Walking faster didn’t appear to help either, as stepping intensity was not associated with mortality risk; however, Dr. Paluch urged a cautious interpretation of this finding, calling it “inconclusive,” and suggesting that more research is needed.
“It is also important to note that this study only looked at premature all-cause mortality, and therefore the results may be different for other health outcomes, such as the risk of cardiovascular disease, or diabetes, cancer, or mental health outcomes,” Dr. Paluch said.
“The results from our study demonstrated that those who are least active have the most to gain,” Dr. Paluch said. “Even small incremental increases in steps per day are associated with a lower mortality risk during middle age. A walking plan that gradually works up toward 7,000-10,000 steps per day in middle-aged adults may have health benefits and lower the risk of premature mortality.”
Causality cannot be confirmed
According to Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), the study size, diverse population, and length of follow-up should increase confidence in the findings, although a causal relationship remains elusive.
“As this study is observational, causality between step count and mortality cannot be confirmed; however, the authors accounted for many factors, and the association was consistent in different analyses and with prior literature,” Dr. Joundi said in an interview. “The authors did not assess the risk of other important events like stroke and heart attack, and these could be addressed in a future study.”
Dr. Joundi, who recently published a study linking exercise with a 50% reduction in mortality after stroke, noted that “physical activity has innumerable benefits, and it’s important that people engage in activity that can be regular and consistent, regardless of the type or intensity.”
To this end, he highlighted the use of “devices capable of monitoring step count, which can be an important motivational tool,” and suggested that these findings may bring a sigh of relief to step counters who come up a little short on a common daily goal.
“A target of 10,000 steps is often used for public health promotion, and this study now provides convincing observational evidence that it may be an optimal step count target for mortality reduction,” Dr. Joundi said. “However, if 10,000 steps per day is not feasible, 7,000 steps seems to be a very reasonable target given its association with markedly lower mortality in this study.”
Not all step counters are equal
Unfortunately, such recommendations are complicated by uncertainty in measurement, as widely used step counting devices, like smart watches, may not yield the same results as research-grade accelerometers, according to Nicole L. Spartano, PhD, of Boston University.
“Many comparison studies have been conducted in laboratory settings among young healthy adults, but these do not necessarily reflect real-life wear experiences that will be generalizable to the population as a whole,” Dr. Spartano wrote in an accompanying editorial.
She called for large-scale comparison studies to compare research-grade and consumer devices.
“The reason for conducting comparison studies is not to develop distinct guidelines for different devices or subgroups of the population, but rather to understand the variability so that we can develop one clear message that is most appropriate to the public,” Dr. Spartano wrote. “Some devices may have bias in terms of step measurement at different activity intensity and may not record steps as accurately in older adults or individuals with obesity or mobility disorders. For example, when adults who were obese wore an ActiGraph monitor in a laboratory setting, the device only recorded 80% of steps walked at a moderate pace, while other devices recorded close to 100% of steps walked. If we in the public health community are to move toward using these devices more for physical activity prescription, these details will need to be explored in more depth.”
CARDIA was conducted and supported by the National Heart, Lung, and Blood Institute in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, and the Kaiser Foundation Research Institute. Some study authors received grants from the National Institutes of Health and the Kaiser Foundation Research Institute. Dr Spartano disclosed relationships with Novo Nordisk, the American Heart Association, the Alzheimer’s Association, and the National Institutes of Health. Dr. Joundi and Dr. Paluch disclosed no relevant financial relationships.
FROM JAMA NETWORK OPEN
2021 AGA Rapid Review and Guideline Update: Pre-endoscopy SARS-CoV-2 testing post vaccination
The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.
Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.
These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.
“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”
The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”
Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.
“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.
The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.
“Across 13 studies, asymptomatic prevalence ranged from 0% to 1.5%, but most studies reported a range from 0% to 0.5%,” the panelists wrote, “regardless of local surges of COVID-19 cases.”
Although Dr. Sultan and colleagues acknowledged that pretesting may be reassuring, they noted that, based on available evidence, “there were few to no cases of infections reported among HCWs (performing endoscopy) and patients. Among the few reported cases, the authors could not clearly distinguish between community-acquired infections or health care–acquired infections.”
They went on to quantify the relationship between delays in care and cancer burden, reviewing data from 14 studies that demonstrated an overall reduction in endoscopic-detected colorectal cancers by 31%-71%, esophageal cancers by 27%-37%, and gastric cancer by 27%-52% since the start of the pandemic. A recent study by Ahmad Khan, MD, and colleagues, which focused on the United States from July to November 2020, demonstrated an 11.74% decrease in diagnoses of malignant colorectal cancer, and a 19.78% decline in diagnoses of esophageal and gastric cancer.
The second recommendation – calling for standard nucleic acid testing among centers electing to maintain a pretesting strategy – was also presented with a summary of supporting evidence, largely pertaining to test accuracy.
“Rapid RT-PCR tests that can be easily performed on the day of endoscopy (results within 1 hour) are preferable as they pose less burden to patients,” the panelists wrote. “In the preprocedure setting, the utility of rapid isothermal tests or antigen tests is limited due to concerns of assay sensitivity. There is no role of antibody tests for preprocedure testing.”
For both new recommendations, it is assumed that “all centers have access to PPE, including face shield, eye protection, and surgical mask or N95 (or N99, powered air-purifying respirators)” and that “all centers have implemented universal screening of patients for COVID-19 symptoms, using a screening checklist, and have implemented universal precautions, including physical distancing, masks, and hand hygiene in the endoscopy unit.”
As COVID-19 cases rise in the United States because of the Delta variant, there is renewed concern about infection and transmission of SARS-CoV2 during endoscopy. Stay tuned for updates and visit https://gastro.org/practice-guidance/practice-updates/covid-19/.
Guideline development was funded by the AGA. No panel members received any payments.
The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.
Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.
These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.
“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”
The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”
Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.
“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.
The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.
“Across 13 studies, asymptomatic prevalence ranged from 0% to 1.5%, but most studies reported a range from 0% to 0.5%,” the panelists wrote, “regardless of local surges of COVID-19 cases.”
Although Dr. Sultan and colleagues acknowledged that pretesting may be reassuring, they noted that, based on available evidence, “there were few to no cases of infections reported among HCWs (performing endoscopy) and patients. Among the few reported cases, the authors could not clearly distinguish between community-acquired infections or health care–acquired infections.”
They went on to quantify the relationship between delays in care and cancer burden, reviewing data from 14 studies that demonstrated an overall reduction in endoscopic-detected colorectal cancers by 31%-71%, esophageal cancers by 27%-37%, and gastric cancer by 27%-52% since the start of the pandemic. A recent study by Ahmad Khan, MD, and colleagues, which focused on the United States from July to November 2020, demonstrated an 11.74% decrease in diagnoses of malignant colorectal cancer, and a 19.78% decline in diagnoses of esophageal and gastric cancer.
The second recommendation – calling for standard nucleic acid testing among centers electing to maintain a pretesting strategy – was also presented with a summary of supporting evidence, largely pertaining to test accuracy.
“Rapid RT-PCR tests that can be easily performed on the day of endoscopy (results within 1 hour) are preferable as they pose less burden to patients,” the panelists wrote. “In the preprocedure setting, the utility of rapid isothermal tests or antigen tests is limited due to concerns of assay sensitivity. There is no role of antibody tests for preprocedure testing.”
For both new recommendations, it is assumed that “all centers have access to PPE, including face shield, eye protection, and surgical mask or N95 (or N99, powered air-purifying respirators)” and that “all centers have implemented universal screening of patients for COVID-19 symptoms, using a screening checklist, and have implemented universal precautions, including physical distancing, masks, and hand hygiene in the endoscopy unit.”
As COVID-19 cases rise in the United States because of the Delta variant, there is renewed concern about infection and transmission of SARS-CoV2 during endoscopy. Stay tuned for updates and visit https://gastro.org/practice-guidance/practice-updates/covid-19/.
Guideline development was funded by the AGA. No panel members received any payments.
The American Gastroenterological Association recently updated their guideline for preendoscopy SARS-CoV-2 testing in light of population-wide vaccination programs, now recommending against routine viral screening regardless of patient vaccination status and local disease prevalence.
Centers electing to maintain a preprocedure testing strategy should use standard nucleic acid testing, preferably rapid reverse transcription polymerase chain reaction (RT-PCR) because this can be performed on the day of the procedure, thereby limiting patient testing burden, reported authors led by co–first authors Shahnaz Sultan, MD, of the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Healthcare System, and Shazia M. Siddique, MD, of the University of Pennsylvania, Philadelphia.
These new recommendations, both of which are conditional and based on very-low-certainty evidence, were drawn from a rapid evidence review of benefits and risks in the postvaccination period.
“Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety,” the guideline authors wrote in Gastroenterology. “Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a reevaluation of AGA’s prior recommendations was warranted.”
The 2020 AGA guideline, also led by Dr. Sultan, issued viral screening recommendations based on local prevalence rates of asymptomatic COVID-19, with pretesting reserved for moderately affected locations. Mildly affected areas were advised against pretesting, whereas centers in pandemic hot spots were cautioned against performing all but “emergency or time-sensitive procedures.”
Those recommendations have now been replaced by the present guideline, which no longer distinguishes between local prevalence rates. This decision was based on a variety of factors, the panelists noted, including endoscopy volumes, vaccine efficacy, HCW and patient anxiety, endoscopy-related risk of infection to both patients and HCWs, prevalence of asymptomatic COVID-19 among patients undergoing endoscopy, and the impact of delaying care on cancer burden.
“The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients,” Dr. Sultan and colleagues wrote.
The guideline includes a summary of evidence related to the two new recommendations, including several studies reporting prevalence of asymptomatic SARS-CoV-2 infection among patients tested prior to endoscopy procedures.
“Across 13 studies, asymptomatic prevalence ranged from 0% to 1.5%, but most studies reported a range from 0% to 0.5%,” the panelists wrote, “regardless of local surges of COVID-19 cases.”
Although Dr. Sultan and colleagues acknowledged that pretesting may be reassuring, they noted that, based on available evidence, “there were few to no cases of infections reported among HCWs (performing endoscopy) and patients. Among the few reported cases, the authors could not clearly distinguish between community-acquired infections or health care–acquired infections.”
They went on to quantify the relationship between delays in care and cancer burden, reviewing data from 14 studies that demonstrated an overall reduction in endoscopic-detected colorectal cancers by 31%-71%, esophageal cancers by 27%-37%, and gastric cancer by 27%-52% since the start of the pandemic. A recent study by Ahmad Khan, MD, and colleagues, which focused on the United States from July to November 2020, demonstrated an 11.74% decrease in diagnoses of malignant colorectal cancer, and a 19.78% decline in diagnoses of esophageal and gastric cancer.
The second recommendation – calling for standard nucleic acid testing among centers electing to maintain a pretesting strategy – was also presented with a summary of supporting evidence, largely pertaining to test accuracy.
“Rapid RT-PCR tests that can be easily performed on the day of endoscopy (results within 1 hour) are preferable as they pose less burden to patients,” the panelists wrote. “In the preprocedure setting, the utility of rapid isothermal tests or antigen tests is limited due to concerns of assay sensitivity. There is no role of antibody tests for preprocedure testing.”
For both new recommendations, it is assumed that “all centers have access to PPE, including face shield, eye protection, and surgical mask or N95 (or N99, powered air-purifying respirators)” and that “all centers have implemented universal screening of patients for COVID-19 symptoms, using a screening checklist, and have implemented universal precautions, including physical distancing, masks, and hand hygiene in the endoscopy unit.”
As COVID-19 cases rise in the United States because of the Delta variant, there is renewed concern about infection and transmission of SARS-CoV2 during endoscopy. Stay tuned for updates and visit https://gastro.org/practice-guidance/practice-updates/covid-19/.
Guideline development was funded by the AGA. No panel members received any payments.
FROM GASTROENTEROLOGY
Pandemic-related drops in breast cancer screening hit hardest among medically underserved
Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.
Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.
“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”
According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.
The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.
Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.
From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.
The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.
The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.
Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.
Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.
“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”
According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”
Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.
“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”
Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.
“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”
Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.
The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.
Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.
Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.
“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”
According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.
The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.
Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.
From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.
The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.
The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.
Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.
Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.
“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”
According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”
Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.
“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”
Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.
“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”
Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.
The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.
Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.
Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.
“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”
According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.
The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.
Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.
From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.
The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.
The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.
Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.
Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.
“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”
According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”
Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.
“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”
Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.
“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”
Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.
The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.
FROM CANCER
Prevalence of youth-onset diabetes climbing, type 2 disease more so in racial/ethnic minorities
The prevalence of youth-onset diabetes in the United States rose significantly from 2001 to 2017, with rates of type 2 diabetes climbing disproportionately among racial/ethnic minorities, according to investigators.
In individuals aged 19 years or younger, prevalence rates of type 1 and type 2 diabetes increased 45.1% and 95.3%, respectively, reported lead author Jean M. Lawrence, ScD, MPH, MSSA, program director of the division of diabetes, endocrinology, and metabolic diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md., and colleagues.
“Elucidating differences in diabetes prevalence trends by diabetes type and demographic characteristics is essential to describe the burden of disease and to estimate current and future resource needs,” Dr. Lawrence and colleagues wrote in JAMA.
The retrospective analysis was a part of the ongoing SEARCH study, which includes data from individuals in six areas across the United States: Colorado, California, Ohio, South Carolina, Washington state, and Arizona/New Mexico (Indian Health Services). In the present report, three prevalence years were evaluated: 2001, 2009, and 2017. For each year, approximately 3.5 million youths were included. Findings were reported in terms of diabetes type, race/ethnicity, age at diagnosis, and sex.
Absolute prevalence of type 1 diabetes per 1,000 youths increased from 1.48 in 2001, to 1.93 in 2009, and finally 2.15 in 2017. Across the 16-year period, this represents an absolute increase of 0.67 (95% confidence interval, 0.64-0.70), and a relative increase of 45.1% (95% CI, 40.0%-50.4%). In absolute terms, prevalence increased most among non-Hispanic White (0.93 per 1,000) and non-Hispanic Black (0.89 per 1,000) youths.
While type 2 diabetes was comparatively less common than type 1 diabetes, absolute prevalence per 1,000 youths increased to a greater degree, rising from 0.34 in 2001 to 0.46 in 2009 and to 0.67 in 2017. This amounts to relative increase across the period of 95.3% (95% CI, 77.0%-115.4%). Absolute increases were disproportionate among racial/ethnic minorities, particularly Black and Hispanic youths, who had absolute increases per 1,000 youths of 0.85 (95% CI, 0.74-0.97) and 0.57 (95% CI, 0.51-0.64), respectively, compared with 0.05 (95% CI, 0.03-0.07) for White youths.
“Increases [among Black and Hispanic youths] were not linear,” the investigators noted. “Hispanic youths had a significantly greater increase in the first interval compared with the second interval, while Black youths had no significant increase in the first interval and a significant increase in the second interval.”
Dr. Lawrence and colleagues offered several possible factors driving these trends in type 2 diabetes.
“Changes in anthropometric risk factors appear to play a significant role,” they wrote, noting that “Black and Mexican American teenagers experienced the greatest increase in prevalence of obesity/severe obesity from 1999 to 2018, which may contribute to race and ethnicity differences. Other contributing factors may include increases in exposure to maternal obesity and diabetes (gestational and type 2 diabetes) and exposure to environmental chemicals.”
According to Megan Kelsey, MD, associate professor of pediatric endocrinology, director of lifestyle medicine endocrinology, and medical director of the bariatric surgery center at Children’s Hospital Colorado, Aurora, the increased rates of type 2 diabetes reported by the study are alarming, yet they pale in comparison with what’s been happening since the pandemic began.
“Individual institutions have reported anywhere between a 50% – which is basically what we’re seeing at our hospital – to a 300% increase in new diagnoses [of type 2 diabetes] in a single-year time period,” Dr. Kelsey said in an interview. “So what is reported [in the present study] doesn’t even get at what’s been going on over the past year and a half.”
Dr. Kelsey offered some speculative drivers of this recent surge in cases, including stress, weight gain caused by sedentary behavior and more access to food, and the possibility that SARS-CoV-2 may infect pancreatic islet beta cells, thereby interfering with insulin production.
Type 2 diabetes is particularly concerning among young people, Dr. Kelsey noted, as it is more challenging to manage than adult-onset disease.
Young patients “also develop complications much sooner than you’d expect,” she added. “So we really need to understand why these rates are increasing, how we can identify kids at risk, and how we can better prevent it, so we aren’t stuck with a disease that’s really difficult to treat.”
To this end, the NIH recently opened applications for investigators to participate in a prospective longitudinal study of youth-onset type 2 diabetes. Young people at risk of diabetes will be followed through puberty, a period of increased risk, according to Dr. Kelsey.
“The goal will be to take kids who don’t yet have [type 2] diabetes, but are at risk, and try to better understand, as some of them progress to developing diabetes, what is going on,” Dr. Kelsey said. “What are other factors that we can use to better predict who’s going to develop diabetes? And can we use the information from this [upcoming] study to understand how to better prevent it? Because nothing that has been tried so far has worked.”
The study was supported by the Centers for Disease Control and Prevention, NIDDK, and others. The investigators and Dr. Kelsey reported no conflicts of interest.
The prevalence of youth-onset diabetes in the United States rose significantly from 2001 to 2017, with rates of type 2 diabetes climbing disproportionately among racial/ethnic minorities, according to investigators.
In individuals aged 19 years or younger, prevalence rates of type 1 and type 2 diabetes increased 45.1% and 95.3%, respectively, reported lead author Jean M. Lawrence, ScD, MPH, MSSA, program director of the division of diabetes, endocrinology, and metabolic diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md., and colleagues.
“Elucidating differences in diabetes prevalence trends by diabetes type and demographic characteristics is essential to describe the burden of disease and to estimate current and future resource needs,” Dr. Lawrence and colleagues wrote in JAMA.
The retrospective analysis was a part of the ongoing SEARCH study, which includes data from individuals in six areas across the United States: Colorado, California, Ohio, South Carolina, Washington state, and Arizona/New Mexico (Indian Health Services). In the present report, three prevalence years were evaluated: 2001, 2009, and 2017. For each year, approximately 3.5 million youths were included. Findings were reported in terms of diabetes type, race/ethnicity, age at diagnosis, and sex.
Absolute prevalence of type 1 diabetes per 1,000 youths increased from 1.48 in 2001, to 1.93 in 2009, and finally 2.15 in 2017. Across the 16-year period, this represents an absolute increase of 0.67 (95% confidence interval, 0.64-0.70), and a relative increase of 45.1% (95% CI, 40.0%-50.4%). In absolute terms, prevalence increased most among non-Hispanic White (0.93 per 1,000) and non-Hispanic Black (0.89 per 1,000) youths.
While type 2 diabetes was comparatively less common than type 1 diabetes, absolute prevalence per 1,000 youths increased to a greater degree, rising from 0.34 in 2001 to 0.46 in 2009 and to 0.67 in 2017. This amounts to relative increase across the period of 95.3% (95% CI, 77.0%-115.4%). Absolute increases were disproportionate among racial/ethnic minorities, particularly Black and Hispanic youths, who had absolute increases per 1,000 youths of 0.85 (95% CI, 0.74-0.97) and 0.57 (95% CI, 0.51-0.64), respectively, compared with 0.05 (95% CI, 0.03-0.07) for White youths.
“Increases [among Black and Hispanic youths] were not linear,” the investigators noted. “Hispanic youths had a significantly greater increase in the first interval compared with the second interval, while Black youths had no significant increase in the first interval and a significant increase in the second interval.”
Dr. Lawrence and colleagues offered several possible factors driving these trends in type 2 diabetes.
“Changes in anthropometric risk factors appear to play a significant role,” they wrote, noting that “Black and Mexican American teenagers experienced the greatest increase in prevalence of obesity/severe obesity from 1999 to 2018, which may contribute to race and ethnicity differences. Other contributing factors may include increases in exposure to maternal obesity and diabetes (gestational and type 2 diabetes) and exposure to environmental chemicals.”
According to Megan Kelsey, MD, associate professor of pediatric endocrinology, director of lifestyle medicine endocrinology, and medical director of the bariatric surgery center at Children’s Hospital Colorado, Aurora, the increased rates of type 2 diabetes reported by the study are alarming, yet they pale in comparison with what’s been happening since the pandemic began.
“Individual institutions have reported anywhere between a 50% – which is basically what we’re seeing at our hospital – to a 300% increase in new diagnoses [of type 2 diabetes] in a single-year time period,” Dr. Kelsey said in an interview. “So what is reported [in the present study] doesn’t even get at what’s been going on over the past year and a half.”
Dr. Kelsey offered some speculative drivers of this recent surge in cases, including stress, weight gain caused by sedentary behavior and more access to food, and the possibility that SARS-CoV-2 may infect pancreatic islet beta cells, thereby interfering with insulin production.
Type 2 diabetes is particularly concerning among young people, Dr. Kelsey noted, as it is more challenging to manage than adult-onset disease.
Young patients “also develop complications much sooner than you’d expect,” she added. “So we really need to understand why these rates are increasing, how we can identify kids at risk, and how we can better prevent it, so we aren’t stuck with a disease that’s really difficult to treat.”
To this end, the NIH recently opened applications for investigators to participate in a prospective longitudinal study of youth-onset type 2 diabetes. Young people at risk of diabetes will be followed through puberty, a period of increased risk, according to Dr. Kelsey.
“The goal will be to take kids who don’t yet have [type 2] diabetes, but are at risk, and try to better understand, as some of them progress to developing diabetes, what is going on,” Dr. Kelsey said. “What are other factors that we can use to better predict who’s going to develop diabetes? And can we use the information from this [upcoming] study to understand how to better prevent it? Because nothing that has been tried so far has worked.”
The study was supported by the Centers for Disease Control and Prevention, NIDDK, and others. The investigators and Dr. Kelsey reported no conflicts of interest.
The prevalence of youth-onset diabetes in the United States rose significantly from 2001 to 2017, with rates of type 2 diabetes climbing disproportionately among racial/ethnic minorities, according to investigators.
In individuals aged 19 years or younger, prevalence rates of type 1 and type 2 diabetes increased 45.1% and 95.3%, respectively, reported lead author Jean M. Lawrence, ScD, MPH, MSSA, program director of the division of diabetes, endocrinology, and metabolic diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md., and colleagues.
“Elucidating differences in diabetes prevalence trends by diabetes type and demographic characteristics is essential to describe the burden of disease and to estimate current and future resource needs,” Dr. Lawrence and colleagues wrote in JAMA.
The retrospective analysis was a part of the ongoing SEARCH study, which includes data from individuals in six areas across the United States: Colorado, California, Ohio, South Carolina, Washington state, and Arizona/New Mexico (Indian Health Services). In the present report, three prevalence years were evaluated: 2001, 2009, and 2017. For each year, approximately 3.5 million youths were included. Findings were reported in terms of diabetes type, race/ethnicity, age at diagnosis, and sex.
Absolute prevalence of type 1 diabetes per 1,000 youths increased from 1.48 in 2001, to 1.93 in 2009, and finally 2.15 in 2017. Across the 16-year period, this represents an absolute increase of 0.67 (95% confidence interval, 0.64-0.70), and a relative increase of 45.1% (95% CI, 40.0%-50.4%). In absolute terms, prevalence increased most among non-Hispanic White (0.93 per 1,000) and non-Hispanic Black (0.89 per 1,000) youths.
While type 2 diabetes was comparatively less common than type 1 diabetes, absolute prevalence per 1,000 youths increased to a greater degree, rising from 0.34 in 2001 to 0.46 in 2009 and to 0.67 in 2017. This amounts to relative increase across the period of 95.3% (95% CI, 77.0%-115.4%). Absolute increases were disproportionate among racial/ethnic minorities, particularly Black and Hispanic youths, who had absolute increases per 1,000 youths of 0.85 (95% CI, 0.74-0.97) and 0.57 (95% CI, 0.51-0.64), respectively, compared with 0.05 (95% CI, 0.03-0.07) for White youths.
“Increases [among Black and Hispanic youths] were not linear,” the investigators noted. “Hispanic youths had a significantly greater increase in the first interval compared with the second interval, while Black youths had no significant increase in the first interval and a significant increase in the second interval.”
Dr. Lawrence and colleagues offered several possible factors driving these trends in type 2 diabetes.
“Changes in anthropometric risk factors appear to play a significant role,” they wrote, noting that “Black and Mexican American teenagers experienced the greatest increase in prevalence of obesity/severe obesity from 1999 to 2018, which may contribute to race and ethnicity differences. Other contributing factors may include increases in exposure to maternal obesity and diabetes (gestational and type 2 diabetes) and exposure to environmental chemicals.”
According to Megan Kelsey, MD, associate professor of pediatric endocrinology, director of lifestyle medicine endocrinology, and medical director of the bariatric surgery center at Children’s Hospital Colorado, Aurora, the increased rates of type 2 diabetes reported by the study are alarming, yet they pale in comparison with what’s been happening since the pandemic began.
“Individual institutions have reported anywhere between a 50% – which is basically what we’re seeing at our hospital – to a 300% increase in new diagnoses [of type 2 diabetes] in a single-year time period,” Dr. Kelsey said in an interview. “So what is reported [in the present study] doesn’t even get at what’s been going on over the past year and a half.”
Dr. Kelsey offered some speculative drivers of this recent surge in cases, including stress, weight gain caused by sedentary behavior and more access to food, and the possibility that SARS-CoV-2 may infect pancreatic islet beta cells, thereby interfering with insulin production.
Type 2 diabetes is particularly concerning among young people, Dr. Kelsey noted, as it is more challenging to manage than adult-onset disease.
Young patients “also develop complications much sooner than you’d expect,” she added. “So we really need to understand why these rates are increasing, how we can identify kids at risk, and how we can better prevent it, so we aren’t stuck with a disease that’s really difficult to treat.”
To this end, the NIH recently opened applications for investigators to participate in a prospective longitudinal study of youth-onset type 2 diabetes. Young people at risk of diabetes will be followed through puberty, a period of increased risk, according to Dr. Kelsey.
“The goal will be to take kids who don’t yet have [type 2] diabetes, but are at risk, and try to better understand, as some of them progress to developing diabetes, what is going on,” Dr. Kelsey said. “What are other factors that we can use to better predict who’s going to develop diabetes? And can we use the information from this [upcoming] study to understand how to better prevent it? Because nothing that has been tried so far has worked.”
The study was supported by the Centers for Disease Control and Prevention, NIDDK, and others. The investigators and Dr. Kelsey reported no conflicts of interest.
FROM JAMA