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New COVID shots will be available in September
The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.
“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.
Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.
“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.
Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context.
“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”
A version of this article was first published on WebMD.com .
The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.
“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.
Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.
“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.
Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context.
“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”
A version of this article was first published on WebMD.com .
The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.
“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.
Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.
“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.
Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context.
“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”
A version of this article was first published on WebMD.com .
Crohn’s link seen for ultraprocessed foods
Ultraprocessed foods contain large amounts of artificial flavors, stabilizers, emulsifiers, sweeteners, or preservatives. Studies have linked higher consumption of them to cardiovascular disease, diabetes, obesity, and cancers.
For their research, published in Clinical Gastroenterology and Hepatology, Neeraj Nerula, MD of McMaster University, Hamilton, Ont., and colleagues pooled data from five recent cohort studies to assess whether their consumption was also linked to inflammatory bowel disease.
The included cohort studies together enrolled more than 1 million participants (mean age, 43-56; 55%-85% female). Of these, 916 developed Crohn’s disease, and 1,934 developed ulcerative colitis, during follow-up. None of the participants had IBD at baseline, and all were followed up at least 1 year. All the studies used the same food classification system, called NOVA, to assess foods eaten, and all were conducted between 2020 and 2022.
People who consumed more ultraprocessed foods saw higher Crohn’s risk, compared with those classed as consuming lower amounts of these foods (hazard ratio, 1.71; 95% confidence interval, 1.37-2.14). Also, lower risk of Crohn’s was observed among participants who consumed more unprocessed or minimally processed foods, such as vegetables, chicken, milk, and eggs (HR, 0.71; 95% CI, 0.53-0.94). The same associations were not seen for ulcerative colitis.
“Our findings support the hypothesis that consumption of [ultraprocessed foods] and low consumption of unprocessed/minimally processed foods may increase the risk for CD,” Dr. Nerula and colleagues wrote. The lack of association seen with ulcerative colitis might be explained by differences in the pathogenesis of each disease.
Ultraprocessed foods might contribute to Crohn’s by disrupting gut microbiota, the authors wrote. “For instance, emulsifiers have been shown to increase epithelial permeability, disruption of the intestinal barrier, and gut dysbiosis in mice. Carboxymethyl cellulose has been shown to facilitate bacterial adherence to gut epithelium, possibly leading to bacterial overgrowth and invasion of bacteria in between the intestinal villi. Furthermore, additives such as carrageenan, titanium dioxide, and maltodextrin have been shown to promote intestinal inflammation.”
Dr. Nerula and colleagues described as strengths of their study its large size, the low heterogenicity of the included studies, and the use of validated, standardized questionnaires to measure dietary intake in each study. Nonetheless, they cautioned, the results might not apply to younger age groups, and the majority of participants were White North Americans and Europeans, making it difficult to generalize results.
“Advancements in food processing and associated changes in dietary patterns could explain the rise of IBD incidence during the 20th and 21st centuries,” Dr. Narula and colleagues concluded. “Further investigations are needed to identify the specific potential culprits among processed foods that could account for the increased risk of CD observed.”
The study authors did not report outside funding. Dr. Narula disclosed receiving fees from pharmaceutical manufacturers including Janssen, AbbVie, Takeda, Pfizer, Merck, and others. Two of coauthors also disclosed receiving funds from industry, and five additional coauthors had no conflicts.
The causes of inflammatory bowel disease (IBD) are thought to be multifactorial and include genetic predisposition, dysregulated immune responses, imbalances in the intestinal microbiota, and environmental exposures.
Incidence and prevalence of IBD has increased over time, including in developing countries, and appear to parallel industrialization and “Westernization” of societies. One of the potential contributors to IBD risk is diet. Dietary changes associated with more modern or “Westernized” diets, including increases in processed foods, are some of the factors hypothesized to contribute to rising rates of IBD.
In the meta-analysis by Narula and colleagues, the authors observed a significant increase in the risk of CD, but not UC, in individuals who consumed significantly higher amounts of ultraprocessed foods (that is, frozen or long-shelf-life foods, products with thickeners/emulsifiers, etc.). Although there are limitations to the studies included in the meta-analysis, the association is intriguing and could point to potential lifestyle modifications that could form the basis of preventative interventions for individuals at higher risk for IBD, such as first-degree relatives.
More immediately, prospective research is needed to understand if restricting ultraprocessed foods (or increasing less-processed foods) can decrease disease activity or prevent flares in patients with IBD.
Understanding factors that predispose to or trigger IBD, such as specific dietary components, will lead to improved management strategies and ultimately preventative interventions.
Ryan Ungaro, MD, MS, is an associate professor of medicine in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He is director of the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD). He has served as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Celltrion, Lilly, Janssen, Pfizer, Roivant, and Takeda, and has received research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Lily, and Pfizer.
The causes of inflammatory bowel disease (IBD) are thought to be multifactorial and include genetic predisposition, dysregulated immune responses, imbalances in the intestinal microbiota, and environmental exposures.
Incidence and prevalence of IBD has increased over time, including in developing countries, and appear to parallel industrialization and “Westernization” of societies. One of the potential contributors to IBD risk is diet. Dietary changes associated with more modern or “Westernized” diets, including increases in processed foods, are some of the factors hypothesized to contribute to rising rates of IBD.
In the meta-analysis by Narula and colleagues, the authors observed a significant increase in the risk of CD, but not UC, in individuals who consumed significantly higher amounts of ultraprocessed foods (that is, frozen or long-shelf-life foods, products with thickeners/emulsifiers, etc.). Although there are limitations to the studies included in the meta-analysis, the association is intriguing and could point to potential lifestyle modifications that could form the basis of preventative interventions for individuals at higher risk for IBD, such as first-degree relatives.
More immediately, prospective research is needed to understand if restricting ultraprocessed foods (or increasing less-processed foods) can decrease disease activity or prevent flares in patients with IBD.
Understanding factors that predispose to or trigger IBD, such as specific dietary components, will lead to improved management strategies and ultimately preventative interventions.
Ryan Ungaro, MD, MS, is an associate professor of medicine in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He is director of the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD). He has served as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Celltrion, Lilly, Janssen, Pfizer, Roivant, and Takeda, and has received research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Lily, and Pfizer.
The causes of inflammatory bowel disease (IBD) are thought to be multifactorial and include genetic predisposition, dysregulated immune responses, imbalances in the intestinal microbiota, and environmental exposures.
Incidence and prevalence of IBD has increased over time, including in developing countries, and appear to parallel industrialization and “Westernization” of societies. One of the potential contributors to IBD risk is diet. Dietary changes associated with more modern or “Westernized” diets, including increases in processed foods, are some of the factors hypothesized to contribute to rising rates of IBD.
In the meta-analysis by Narula and colleagues, the authors observed a significant increase in the risk of CD, but not UC, in individuals who consumed significantly higher amounts of ultraprocessed foods (that is, frozen or long-shelf-life foods, products with thickeners/emulsifiers, etc.). Although there are limitations to the studies included in the meta-analysis, the association is intriguing and could point to potential lifestyle modifications that could form the basis of preventative interventions for individuals at higher risk for IBD, such as first-degree relatives.
More immediately, prospective research is needed to understand if restricting ultraprocessed foods (or increasing less-processed foods) can decrease disease activity or prevent flares in patients with IBD.
Understanding factors that predispose to or trigger IBD, such as specific dietary components, will lead to improved management strategies and ultimately preventative interventions.
Ryan Ungaro, MD, MS, is an associate professor of medicine in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He is director of the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD). He has served as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Celltrion, Lilly, Janssen, Pfizer, Roivant, and Takeda, and has received research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Lily, and Pfizer.
Ultraprocessed foods contain large amounts of artificial flavors, stabilizers, emulsifiers, sweeteners, or preservatives. Studies have linked higher consumption of them to cardiovascular disease, diabetes, obesity, and cancers.
For their research, published in Clinical Gastroenterology and Hepatology, Neeraj Nerula, MD of McMaster University, Hamilton, Ont., and colleagues pooled data from five recent cohort studies to assess whether their consumption was also linked to inflammatory bowel disease.
The included cohort studies together enrolled more than 1 million participants (mean age, 43-56; 55%-85% female). Of these, 916 developed Crohn’s disease, and 1,934 developed ulcerative colitis, during follow-up. None of the participants had IBD at baseline, and all were followed up at least 1 year. All the studies used the same food classification system, called NOVA, to assess foods eaten, and all were conducted between 2020 and 2022.
People who consumed more ultraprocessed foods saw higher Crohn’s risk, compared with those classed as consuming lower amounts of these foods (hazard ratio, 1.71; 95% confidence interval, 1.37-2.14). Also, lower risk of Crohn’s was observed among participants who consumed more unprocessed or minimally processed foods, such as vegetables, chicken, milk, and eggs (HR, 0.71; 95% CI, 0.53-0.94). The same associations were not seen for ulcerative colitis.
“Our findings support the hypothesis that consumption of [ultraprocessed foods] and low consumption of unprocessed/minimally processed foods may increase the risk for CD,” Dr. Nerula and colleagues wrote. The lack of association seen with ulcerative colitis might be explained by differences in the pathogenesis of each disease.
Ultraprocessed foods might contribute to Crohn’s by disrupting gut microbiota, the authors wrote. “For instance, emulsifiers have been shown to increase epithelial permeability, disruption of the intestinal barrier, and gut dysbiosis in mice. Carboxymethyl cellulose has been shown to facilitate bacterial adherence to gut epithelium, possibly leading to bacterial overgrowth and invasion of bacteria in between the intestinal villi. Furthermore, additives such as carrageenan, titanium dioxide, and maltodextrin have been shown to promote intestinal inflammation.”
Dr. Nerula and colleagues described as strengths of their study its large size, the low heterogenicity of the included studies, and the use of validated, standardized questionnaires to measure dietary intake in each study. Nonetheless, they cautioned, the results might not apply to younger age groups, and the majority of participants were White North Americans and Europeans, making it difficult to generalize results.
“Advancements in food processing and associated changes in dietary patterns could explain the rise of IBD incidence during the 20th and 21st centuries,” Dr. Narula and colleagues concluded. “Further investigations are needed to identify the specific potential culprits among processed foods that could account for the increased risk of CD observed.”
The study authors did not report outside funding. Dr. Narula disclosed receiving fees from pharmaceutical manufacturers including Janssen, AbbVie, Takeda, Pfizer, Merck, and others. Two of coauthors also disclosed receiving funds from industry, and five additional coauthors had no conflicts.
Ultraprocessed foods contain large amounts of artificial flavors, stabilizers, emulsifiers, sweeteners, or preservatives. Studies have linked higher consumption of them to cardiovascular disease, diabetes, obesity, and cancers.
For their research, published in Clinical Gastroenterology and Hepatology, Neeraj Nerula, MD of McMaster University, Hamilton, Ont., and colleagues pooled data from five recent cohort studies to assess whether their consumption was also linked to inflammatory bowel disease.
The included cohort studies together enrolled more than 1 million participants (mean age, 43-56; 55%-85% female). Of these, 916 developed Crohn’s disease, and 1,934 developed ulcerative colitis, during follow-up. None of the participants had IBD at baseline, and all were followed up at least 1 year. All the studies used the same food classification system, called NOVA, to assess foods eaten, and all were conducted between 2020 and 2022.
People who consumed more ultraprocessed foods saw higher Crohn’s risk, compared with those classed as consuming lower amounts of these foods (hazard ratio, 1.71; 95% confidence interval, 1.37-2.14). Also, lower risk of Crohn’s was observed among participants who consumed more unprocessed or minimally processed foods, such as vegetables, chicken, milk, and eggs (HR, 0.71; 95% CI, 0.53-0.94). The same associations were not seen for ulcerative colitis.
“Our findings support the hypothesis that consumption of [ultraprocessed foods] and low consumption of unprocessed/minimally processed foods may increase the risk for CD,” Dr. Nerula and colleagues wrote. The lack of association seen with ulcerative colitis might be explained by differences in the pathogenesis of each disease.
Ultraprocessed foods might contribute to Crohn’s by disrupting gut microbiota, the authors wrote. “For instance, emulsifiers have been shown to increase epithelial permeability, disruption of the intestinal barrier, and gut dysbiosis in mice. Carboxymethyl cellulose has been shown to facilitate bacterial adherence to gut epithelium, possibly leading to bacterial overgrowth and invasion of bacteria in between the intestinal villi. Furthermore, additives such as carrageenan, titanium dioxide, and maltodextrin have been shown to promote intestinal inflammation.”
Dr. Nerula and colleagues described as strengths of their study its large size, the low heterogenicity of the included studies, and the use of validated, standardized questionnaires to measure dietary intake in each study. Nonetheless, they cautioned, the results might not apply to younger age groups, and the majority of participants were White North Americans and Europeans, making it difficult to generalize results.
“Advancements in food processing and associated changes in dietary patterns could explain the rise of IBD incidence during the 20th and 21st centuries,” Dr. Narula and colleagues concluded. “Further investigations are needed to identify the specific potential culprits among processed foods that could account for the increased risk of CD observed.”
The study authors did not report outside funding. Dr. Narula disclosed receiving fees from pharmaceutical manufacturers including Janssen, AbbVie, Takeda, Pfizer, Merck, and others. Two of coauthors also disclosed receiving funds from industry, and five additional coauthors had no conflicts.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
FDA approves elranatamab for multiple myeloma
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
Advancements help guide achalasia management, experts say
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
FROM GASTRO HEP ADVANCES
News & Perspectives from Ob.Gyn. News
NEWS FROM THE FDA/CDC
FDA approves first over-the-counter birth control pill
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
https://www.mdedge.com/obgyn/news-fda/cdc
FEATURE
U.S. mammogram update sparks concern, reignites debates
A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.
The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.
The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.
For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.
However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen-ing mammogram.
A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.
https://www.mdedge.com/obgyn/article/264198/breast-cancer/us-mammogram-update-sparks-concern-reignites-debates
Continue to: GENDER-AFFIRMING GYNECOLOGY...
GENDER-AFFIRMING GYNECOLOGY
Updates on pregnancy outcomes in transgender men
Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.
Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.
Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.
https://www.mdedge.com/obgyn/gender-affirming-gynecology
REPRODUCTIVE ROUNDS
Affordable IVF—Are we there yet?
The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.
The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.
The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.
https://www.mdedge.com/obgyn/reproductive-rounds
CONFERENCE COVERAGE
‘Artificial pancreas’ for all type 1 diabetes pregnancies?
In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.
The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.
Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.
The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.
CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”
The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.
NEWS FROM THE FDA/CDC
FDA approves first over-the-counter birth control pill
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
https://www.mdedge.com/obgyn/news-fda/cdc
FEATURE
U.S. mammogram update sparks concern, reignites debates
A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.
The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.
The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.
For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.
However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen-ing mammogram.
A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.
https://www.mdedge.com/obgyn/article/264198/breast-cancer/us-mammogram-update-sparks-concern-reignites-debates
Continue to: GENDER-AFFIRMING GYNECOLOGY...
GENDER-AFFIRMING GYNECOLOGY
Updates on pregnancy outcomes in transgender men
Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.
Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.
Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.
https://www.mdedge.com/obgyn/gender-affirming-gynecology
REPRODUCTIVE ROUNDS
Affordable IVF—Are we there yet?
The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.
The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.
The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.
https://www.mdedge.com/obgyn/reproductive-rounds
CONFERENCE COVERAGE
‘Artificial pancreas’ for all type 1 diabetes pregnancies?
In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.
The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.
Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.
The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.
CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”
The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.
NEWS FROM THE FDA/CDC
FDA approves first over-the-counter birth control pill
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
https://www.mdedge.com/obgyn/news-fda/cdc
FEATURE
U.S. mammogram update sparks concern, reignites debates
A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.
The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.
The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.
For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.
However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen-ing mammogram.
A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.
https://www.mdedge.com/obgyn/article/264198/breast-cancer/us-mammogram-update-sparks-concern-reignites-debates
Continue to: GENDER-AFFIRMING GYNECOLOGY...
GENDER-AFFIRMING GYNECOLOGY
Updates on pregnancy outcomes in transgender men
Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.
Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.
Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.
https://www.mdedge.com/obgyn/gender-affirming-gynecology
REPRODUCTIVE ROUNDS
Affordable IVF—Are we there yet?
The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.
The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.
The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.
https://www.mdedge.com/obgyn/reproductive-rounds
CONFERENCE COVERAGE
‘Artificial pancreas’ for all type 1 diabetes pregnancies?
In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.
The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.
Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.
The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.
CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”
The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.
Fluctuant facial lesions
This patient had more than cystic acne; he had acne conglobata. AC is a severe form of inflammatory acne leading to coalescing lesions with purulent sinus tracts under the skin. It can be seen as part of the follicular tetrad syndrome of cystic acne, hidradenitis suppurativa, dissecting cellulitis, and pilonidal disease. AC is thought to be an elevated tumor necrosis factor (TNF)-alpha response to Propionibacterium acnes (now known as Cutibacterium acnes) that leads to excessive inflammation and sterile abscesses.1 Acne fulminans (AF) can also manifest as a purulent form of acne, but AF has associated systemic signs and symptoms that include fevers, chills, and malaise.
Due to the depth of the inflammation, AC is treated with systemic medications, most commonly isotretinoin. Isotretinoin can be started at 0.5 mg/kg (divided twice daily to enhance tolerability) and then increased to 1 mg/kg (divided twice daily) for 5 months. There is some variation in dosing regimens in practice; the target goal is 120 to 150 mg/kg over the course of treatment. In AF, the patient is pretreated with systemic steroids, and in AC, some clinicians will even prescribe systemic steroids (prednisone 0.5 mg/kg daily for the first month) along with isotretinoin.
Second-line medications include dapsone (50-150 mg/d).2 Case reports describe the successful use of the TNF-alpha antagonist adalimumab, although this is not a usual practice in AC treatment.1 Note that all of these medications have the potential for severe adverse effects and require laboratory evaluation prior to initiation.
This patient was counseled, prescribed isotretinoin (dose as above), and enrolled in the IPledge prescribing and monitoring system for isotretinoin. At 20 weeks of use, the purulent drainage ceased. The pus-filled sinus tracts and redness had resolved, although he still had thickened tissue and scarring where the tracts had been. In time, the scars will usually get flatter and softer.
If the patient’s AC were to flare, another 20-week course of isotretinoin could be prescribed after a 2-month hiatus or he could be switched to a second-line medication. Referral for any cosmetic therapy is typically delayed for another 6 months in case there is a need to treat a recurrence.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Yiu ZZ, Madan V, Griffiths CE. Acne conglobata and adalimumab: use of tumour necrosis factor-α antagonists in treatment-resistant acne conglobata, and review of the literature. Clin Exp Dermatol. 2015;40:383-386. doi: 10.1111/ced.12540
2. Hafsi W, Arnold DL, Kassardjian M. Acne Conglobata. StatPearls Publishing; 2023.
This patient had more than cystic acne; he had acne conglobata. AC is a severe form of inflammatory acne leading to coalescing lesions with purulent sinus tracts under the skin. It can be seen as part of the follicular tetrad syndrome of cystic acne, hidradenitis suppurativa, dissecting cellulitis, and pilonidal disease. AC is thought to be an elevated tumor necrosis factor (TNF)-alpha response to Propionibacterium acnes (now known as Cutibacterium acnes) that leads to excessive inflammation and sterile abscesses.1 Acne fulminans (AF) can also manifest as a purulent form of acne, but AF has associated systemic signs and symptoms that include fevers, chills, and malaise.
Due to the depth of the inflammation, AC is treated with systemic medications, most commonly isotretinoin. Isotretinoin can be started at 0.5 mg/kg (divided twice daily to enhance tolerability) and then increased to 1 mg/kg (divided twice daily) for 5 months. There is some variation in dosing regimens in practice; the target goal is 120 to 150 mg/kg over the course of treatment. In AF, the patient is pretreated with systemic steroids, and in AC, some clinicians will even prescribe systemic steroids (prednisone 0.5 mg/kg daily for the first month) along with isotretinoin.
Second-line medications include dapsone (50-150 mg/d).2 Case reports describe the successful use of the TNF-alpha antagonist adalimumab, although this is not a usual practice in AC treatment.1 Note that all of these medications have the potential for severe adverse effects and require laboratory evaluation prior to initiation.
This patient was counseled, prescribed isotretinoin (dose as above), and enrolled in the IPledge prescribing and monitoring system for isotretinoin. At 20 weeks of use, the purulent drainage ceased. The pus-filled sinus tracts and redness had resolved, although he still had thickened tissue and scarring where the tracts had been. In time, the scars will usually get flatter and softer.
If the patient’s AC were to flare, another 20-week course of isotretinoin could be prescribed after a 2-month hiatus or he could be switched to a second-line medication. Referral for any cosmetic therapy is typically delayed for another 6 months in case there is a need to treat a recurrence.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
This patient had more than cystic acne; he had acne conglobata. AC is a severe form of inflammatory acne leading to coalescing lesions with purulent sinus tracts under the skin. It can be seen as part of the follicular tetrad syndrome of cystic acne, hidradenitis suppurativa, dissecting cellulitis, and pilonidal disease. AC is thought to be an elevated tumor necrosis factor (TNF)-alpha response to Propionibacterium acnes (now known as Cutibacterium acnes) that leads to excessive inflammation and sterile abscesses.1 Acne fulminans (AF) can also manifest as a purulent form of acne, but AF has associated systemic signs and symptoms that include fevers, chills, and malaise.
Due to the depth of the inflammation, AC is treated with systemic medications, most commonly isotretinoin. Isotretinoin can be started at 0.5 mg/kg (divided twice daily to enhance tolerability) and then increased to 1 mg/kg (divided twice daily) for 5 months. There is some variation in dosing regimens in practice; the target goal is 120 to 150 mg/kg over the course of treatment. In AF, the patient is pretreated with systemic steroids, and in AC, some clinicians will even prescribe systemic steroids (prednisone 0.5 mg/kg daily for the first month) along with isotretinoin.
Second-line medications include dapsone (50-150 mg/d).2 Case reports describe the successful use of the TNF-alpha antagonist adalimumab, although this is not a usual practice in AC treatment.1 Note that all of these medications have the potential for severe adverse effects and require laboratory evaluation prior to initiation.
This patient was counseled, prescribed isotretinoin (dose as above), and enrolled in the IPledge prescribing and monitoring system for isotretinoin. At 20 weeks of use, the purulent drainage ceased. The pus-filled sinus tracts and redness had resolved, although he still had thickened tissue and scarring where the tracts had been. In time, the scars will usually get flatter and softer.
If the patient’s AC were to flare, another 20-week course of isotretinoin could be prescribed after a 2-month hiatus or he could be switched to a second-line medication. Referral for any cosmetic therapy is typically delayed for another 6 months in case there is a need to treat a recurrence.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Yiu ZZ, Madan V, Griffiths CE. Acne conglobata and adalimumab: use of tumour necrosis factor-α antagonists in treatment-resistant acne conglobata, and review of the literature. Clin Exp Dermatol. 2015;40:383-386. doi: 10.1111/ced.12540
2. Hafsi W, Arnold DL, Kassardjian M. Acne Conglobata. StatPearls Publishing; 2023.
1. Yiu ZZ, Madan V, Griffiths CE. Acne conglobata and adalimumab: use of tumour necrosis factor-α antagonists in treatment-resistant acne conglobata, and review of the literature. Clin Exp Dermatol. 2015;40:383-386. doi: 10.1111/ced.12540
2. Hafsi W, Arnold DL, Kassardjian M. Acne Conglobata. StatPearls Publishing; 2023.
Leathery plaque on thigh
The necrotic eschar on this patient’s thigh is calciphylaxis, also known as calcific uremic arteriolopathy (CUA). Most cases are seen in ESRD and start as painful erythematous, firm lesions that progress to necrotic eschars. Up to 4% of patients with ESRD who are on dialysis develop CUA.1
The exact pathology of CUA is unknown. Calcification of the arterioles leads to ischemia and necrosis of tissue, which is not limited to the skin and can affect tissue elsewhere (eg, muscles, central nervous system, internal organs).2
Morbidity and mortality of CUA is often due to bacterial infections and sepsis related to the necrotic tissue. CUA can be treated with sodium thiosulfate (25 g in 100 mL of normal saline) infused intravenously during the last 30 minutes of dialysis treatment 3 times per week.3 Sodium thiosulfate (which acts as a calcium binder) and cinacalcet (a calcimimetic that leads to lower parathyroid hormone levels) have been used, but evidence of efficacy is limited. In a multicenter observational study involving 89 patients with chronic kidney disease and CUA, 17% of patients experienced complete wound healing, while 56% died over a median follow-up period of 5.8 months.1 (No cause of death data were available; sodium thiosulfate and a calcimimetic were the most widely used treatment strategies.) This extrapolated to a mortality rate of 72 patients per 100 individuals over the course of 1 year (the 100 patient-years rate).1
This patient continued her dialysis regimen and general care. She was seen by the wound care team and treated with topical wound care, including moist dressings for her open lesions. The eschars were not debrided because they showed no sign of active infection. Unfortunately, she was in extremely frail condition and died 1 month after evaluation.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Chinnadurai R, Huckle A, Hegarty J, et al. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-1545. doi: 10.1007/s40620-020-00908-9
2. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034
3. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034
The necrotic eschar on this patient’s thigh is calciphylaxis, also known as calcific uremic arteriolopathy (CUA). Most cases are seen in ESRD and start as painful erythematous, firm lesions that progress to necrotic eschars. Up to 4% of patients with ESRD who are on dialysis develop CUA.1
The exact pathology of CUA is unknown. Calcification of the arterioles leads to ischemia and necrosis of tissue, which is not limited to the skin and can affect tissue elsewhere (eg, muscles, central nervous system, internal organs).2
Morbidity and mortality of CUA is often due to bacterial infections and sepsis related to the necrotic tissue. CUA can be treated with sodium thiosulfate (25 g in 100 mL of normal saline) infused intravenously during the last 30 minutes of dialysis treatment 3 times per week.3 Sodium thiosulfate (which acts as a calcium binder) and cinacalcet (a calcimimetic that leads to lower parathyroid hormone levels) have been used, but evidence of efficacy is limited. In a multicenter observational study involving 89 patients with chronic kidney disease and CUA, 17% of patients experienced complete wound healing, while 56% died over a median follow-up period of 5.8 months.1 (No cause of death data were available; sodium thiosulfate and a calcimimetic were the most widely used treatment strategies.) This extrapolated to a mortality rate of 72 patients per 100 individuals over the course of 1 year (the 100 patient-years rate).1
This patient continued her dialysis regimen and general care. She was seen by the wound care team and treated with topical wound care, including moist dressings for her open lesions. The eschars were not debrided because they showed no sign of active infection. Unfortunately, she was in extremely frail condition and died 1 month after evaluation.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
The necrotic eschar on this patient’s thigh is calciphylaxis, also known as calcific uremic arteriolopathy (CUA). Most cases are seen in ESRD and start as painful erythematous, firm lesions that progress to necrotic eschars. Up to 4% of patients with ESRD who are on dialysis develop CUA.1
The exact pathology of CUA is unknown. Calcification of the arterioles leads to ischemia and necrosis of tissue, which is not limited to the skin and can affect tissue elsewhere (eg, muscles, central nervous system, internal organs).2
Morbidity and mortality of CUA is often due to bacterial infections and sepsis related to the necrotic tissue. CUA can be treated with sodium thiosulfate (25 g in 100 mL of normal saline) infused intravenously during the last 30 minutes of dialysis treatment 3 times per week.3 Sodium thiosulfate (which acts as a calcium binder) and cinacalcet (a calcimimetic that leads to lower parathyroid hormone levels) have been used, but evidence of efficacy is limited. In a multicenter observational study involving 89 patients with chronic kidney disease and CUA, 17% of patients experienced complete wound healing, while 56% died over a median follow-up period of 5.8 months.1 (No cause of death data were available; sodium thiosulfate and a calcimimetic were the most widely used treatment strategies.) This extrapolated to a mortality rate of 72 patients per 100 individuals over the course of 1 year (the 100 patient-years rate).1
This patient continued her dialysis regimen and general care. She was seen by the wound care team and treated with topical wound care, including moist dressings for her open lesions. The eschars were not debrided because they showed no sign of active infection. Unfortunately, she was in extremely frail condition and died 1 month after evaluation.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Chinnadurai R, Huckle A, Hegarty J, et al. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-1545. doi: 10.1007/s40620-020-00908-9
2. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034
3. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034
1. Chinnadurai R, Huckle A, Hegarty J, et al. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-1545. doi: 10.1007/s40620-020-00908-9
2. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034
3. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034
Gastrointestinal Bleeding Caused by Large Intestine Amyloidosis
Gastrointestinal (GI) bleeding is a common cause of hospital admissions. The yearly incidence of upper GI bleeding is 80 to 150/100,000 people and lower GI bleeding is 87/100,000 people.1,2 The differential tends to initially be broad but narrows with good history followed by endoscopic findings. Getting an appropriate history can be difficult at times, which leads health care practitioners to rely more on interventional results.
Amyloidosis is a rare disorder of abnormal protein folding, leading to the deposition of insoluble fibrils that disrupt normal tissues and cause disease.3 There are 2 main types of amyloidosis, systemic and transthyretin, and 4 subtypes. Systemic amyloidosis includes amyloid light-chain (AL) deposition, caused by plasma cell dyscrasia, and amyloid A (AA) protein deposition, caused by systemic autoimmune illness or infections. Transthyretin amyloidosis is caused by changes and deposition of the transthyretin protein consisting of either unstable, mutant protein or wild type protein. Biopsy-proven amyloidosis of the GI tract is rare.4 About 60% of patients with AA amyloidosis and 8% with AL amyloidosis have GI involvement.5
We present a case of nonspecific symptoms that ultimately lined up perfectly with the official histologic confirmation of intestinal amyloidosis.
Case Presentation
A 79-year-old man with a history of type 2 diabetes mellitus, congestive heart failure, hyperlipidemia, obstructive sleep apnea, hypothyroidism, hypertension, coronary artery disease status postcoronary artery bypass grafting, and stent placements presented for 3 episodes of large, bright red bowel movements. He reported past bleeding and straining with stools, but bleeding of this amount had not been noted prior. He also reported dry heaves, lower abdominal pain, constipation with straining, early satiety with dysphagia, weakness, and decreased appetite. Lastly, he mentioned intentionally losing about 35 to 40 pounds in the past 3 to 4 months and over the past several months increased abdominal distention. However, he stated he had no history of alcohol misuse, liver or intestinal disease, cirrhosis, or other autoimmune diseases. His most recent colonoscopy was more than a decade prior and showed no acute process. The patient never had an esophagogastroduodenoscopy (EGD).
On initial presentation, the patient’s vital signs showed no acute findings. His physical examination noted a chronically ill–appearing male with decreased breath sounds to the bases bilaterally and noted abdominal distention with mild generalized tenderness. Laboratory findings were significant for a hemoglobin level, 9.4 g/dL (reference range, 11.6-15.3); iron, 23 ug/dL (reference range, 45-160); transferrin saturation, 8% (reference range, 15-50); ferritin level, 80 ng/mL (reference range, 30-300); and carcinoembryonic antigen level, 1.5 ng/mL (reference range, 0-2.9). Aspartate aminotransferase level was 54 IU/L (reference range, 0-40); alanine transaminase, 24 IU/L (reference range, 7-52); albumin, 2.7 g/dL (reference range, 3.4-5.7); international normalized ratio, 1.3 (reference range, 0-1.1); creatinine, 1.74 mg/dL (reference range, 0.44-1.27); alkaline phosphatase, 369 IU/L (reference range, 39-117). White blood cell count was 15.5 × 109/L (reference range, 3.5-10.3), and lactic acid was 2.5 mmol/L (reference range, 0.5-2.2). He was started on piperacillin/tazobactam in the emergency department and transitioned to ciprofloxacin and metronidazole for presumed intra-abdominal infection. Paracentesis showed a serum ascites albumin gradient of > 1.1 g/dL with no signs of spontaneous bacterial peritonitis. Computed tomography of the abdomen and pelvis with contrast was suspicious for colitis involving the proximal colon, and colonic mass could not be excluded. Also noted was hepatosplenomegaly with abdominopelvic ascites.
Based on these findings, an EGD and colonoscopy were done. The EGD showed mild portal hypertensive gastropathy. 
After the biopsy results, the patient was officially diagnosed with intestinal amyloidosis (Figure 2). 
He returned to the gastroenterology clinic 2 months later. At that point, he had worsening symptoms, liver function test results, and international normalized ratio. He was admitted for further investigation. A bone biopsy was done to confirm the histology and define the underlying disorder. The biopsy returned showing Waldenstrom macroglobulinemia, and he was started on bortezomib. Unfortunately, his clinical status rapidly worsened, leading to acute renal and hepatic failure and the development of encephalopathy. He eventually died under palliative care services.
Discussion
Amyloidosis is a rare disorder of abnormal protein folding, leading to the deposition of insoluble fibrils that disrupt normal tissues and cause disease.3 There are several variations of amyloid, but the most common type is AL amyloidosis, which affects several organs, including the heart, kidney, liver, nervous system, and GI tract. When AL amyloidosis involves the liver, the median survival time is about 8.5 months.6 There are different ways to diagnose the disease, but a tissue biopsy and Congo Red staining can confirm specific organ involvement as seen in our case.
This case adds another layer to our constantly expanding differential as health care practitioners and proves that atypical patient presentations may not be atypical after all. GI amyloidosis tends to present similarly to our patient with bleeding, malabsorption, dysmotility, and protein-losing gastroenteropathy as ascites, edema, pericardial effusions, and laboratory evidence of hypoalbuminemia.7 Because amyloidosis is a systemic illness, early recognition is important as intestinal complications tend to present as symptoms, but mortality is more often caused by renal failure, cardiomyopathy, or ischemic heart disease, making early multispecialty involvement very important.8
Conclusions
Health care practitioners in all specialties should be aware of and include intestinal amyloidosis in their differential diagnosis when working up GI bleeds with the hope of identifying the disease early. With early recognition, rapid biopsy identification, and early specialist involvement, patients will get the opportunity for expedited multidisciplinary treatment and potentially delay rapid decompensation as shown by the evidence in this case.
1. Antunes C, Copelin II EL. Upper gastrointestinal bleeding. StatPearls [internet]. Updated July 18, 2022. Accessed May 25, 2023. https://www.ncbi.nlm.nih.gov/books/NBK470300
2. Almaghrabi M, Gandhi M, Guizzetti L, et al. Comparison of risk scores for lower gastrointestinal bleeding: a systematic review and meta-analysis. JAMA Netw Open. 2022;5(5):e2214253. doi:10.1001/jamanetworkopen.2022.14253
3. Pepys MB. Pathogenesis, diagnosis and treatment of systemic amyloidosis. Philos Trans R Soc Lond B Biol Sci. 2001;356(1406):203-211. doi:10.1098/rstb.2000.0766
4. Cowan AJ, Skinner M, Seldin DC, et al. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013;98(1):141-146. doi:10.3324/haematol.2012.068155
5. Lee BS, Chudasama Y, Chen AI, Lim BS, Taira MT. Colonoscopy leading to the diagnosis of AL amyloidosis in the gastrointestinal tract mimicking an acute ulcerative colitis flare. ACG Case Rep J. 2019;6(11):e00289. doi:10.14309/crj.0000000000000289
6. Zhao L, Ren G, Guo J, Chen W, Xu W, Huang X. The clinical features and outcomes of systemic light chain amyloidosis with hepatic involvement. Ann Med. 2022;54(1):1226-1232. doi:10.1080/07853890.2022.2069281
7. Rowe K, Pankow J, Nehme F, Salyers W. Gastrointestinal amyloidosis: review of the literature. Cureus. 2017;9(5):e1228. doi:10.7759/cureus.1228
8. Kyle RA, Greipp PR, O’Fallon WM. Primary systemic amyloidosis: multivariate analysis for prognostic factors in 168 cases. Blood. 1986;68(1):220-224.
Gastrointestinal (GI) bleeding is a common cause of hospital admissions. The yearly incidence of upper GI bleeding is 80 to 150/100,000 people and lower GI bleeding is 87/100,000 people.1,2 The differential tends to initially be broad but narrows with good history followed by endoscopic findings. Getting an appropriate history can be difficult at times, which leads health care practitioners to rely more on interventional results.
Amyloidosis is a rare disorder of abnormal protein folding, leading to the deposition of insoluble fibrils that disrupt normal tissues and cause disease.3 There are 2 main types of amyloidosis, systemic and transthyretin, and 4 subtypes. Systemic amyloidosis includes amyloid light-chain (AL) deposition, caused by plasma cell dyscrasia, and amyloid A (AA) protein deposition, caused by systemic autoimmune illness or infections. Transthyretin amyloidosis is caused by changes and deposition of the transthyretin protein consisting of either unstable, mutant protein or wild type protein. Biopsy-proven amyloidosis of the GI tract is rare.4 About 60% of patients with AA amyloidosis and 8% with AL amyloidosis have GI involvement.5
We present a case of nonspecific symptoms that ultimately lined up perfectly with the official histologic confirmation of intestinal amyloidosis.
Case Presentation
A 79-year-old man with a history of type 2 diabetes mellitus, congestive heart failure, hyperlipidemia, obstructive sleep apnea, hypothyroidism, hypertension, coronary artery disease status postcoronary artery bypass grafting, and stent placements presented for 3 episodes of large, bright red bowel movements. He reported past bleeding and straining with stools, but bleeding of this amount had not been noted prior. He also reported dry heaves, lower abdominal pain, constipation with straining, early satiety with dysphagia, weakness, and decreased appetite. Lastly, he mentioned intentionally losing about 35 to 40 pounds in the past 3 to 4 months and over the past several months increased abdominal distention. However, he stated he had no history of alcohol misuse, liver or intestinal disease, cirrhosis, or other autoimmune diseases. His most recent colonoscopy was more than a decade prior and showed no acute process. The patient never had an esophagogastroduodenoscopy (EGD).
On initial presentation, the patient’s vital signs showed no acute findings. His physical examination noted a chronically ill–appearing male with decreased breath sounds to the bases bilaterally and noted abdominal distention with mild generalized tenderness. Laboratory findings were significant for a hemoglobin level, 9.4 g/dL (reference range, 11.6-15.3); iron, 23 ug/dL (reference range, 45-160); transferrin saturation, 8% (reference range, 15-50); ferritin level, 80 ng/mL (reference range, 30-300); and carcinoembryonic antigen level, 1.5 ng/mL (reference range, 0-2.9). Aspartate aminotransferase level was 54 IU/L (reference range, 0-40); alanine transaminase, 24 IU/L (reference range, 7-52); albumin, 2.7 g/dL (reference range, 3.4-5.7); international normalized ratio, 1.3 (reference range, 0-1.1); creatinine, 1.74 mg/dL (reference range, 0.44-1.27); alkaline phosphatase, 369 IU/L (reference range, 39-117). White blood cell count was 15.5 × 109/L (reference range, 3.5-10.3), and lactic acid was 2.5 mmol/L (reference range, 0.5-2.2). He was started on piperacillin/tazobactam in the emergency department and transitioned to ciprofloxacin and metronidazole for presumed intra-abdominal infection. Paracentesis showed a serum ascites albumin gradient of > 1.1 g/dL with no signs of spontaneous bacterial peritonitis. Computed tomography of the abdomen and pelvis with contrast was suspicious for colitis involving the proximal colon, and colonic mass could not be excluded. Also noted was hepatosplenomegaly with abdominopelvic ascites.
Based on these findings, an EGD and colonoscopy were done. The EGD showed mild portal hypertensive gastropathy.
After the biopsy results, the patient was officially diagnosed with intestinal amyloidosis (Figure 2).
He returned to the gastroenterology clinic 2 months later. At that point, he had worsening symptoms, liver function test results, and international normalized ratio. He was admitted for further investigation. A bone biopsy was done to confirm the histology and define the underlying disorder. The biopsy returned showing Waldenstrom macroglobulinemia, and he was started on bortezomib. Unfortunately, his clinical status rapidly worsened, leading to acute renal and hepatic failure and the development of encephalopathy. He eventually died under palliative care services.
Discussion
Amyloidosis is a rare disorder of abnormal protein folding, leading to the deposition of insoluble fibrils that disrupt normal tissues and cause disease.3 There are several variations of amyloid, but the most common type is AL amyloidosis, which affects several organs, including the heart, kidney, liver, nervous system, and GI tract. When AL amyloidosis involves the liver, the median survival time is about 8.5 months.6 There are different ways to diagnose the disease, but a tissue biopsy and Congo Red staining can confirm specific organ involvement as seen in our case.
This case adds another layer to our constantly expanding differential as health care practitioners and proves that atypical patient presentations may not be atypical after all. GI amyloidosis tends to present similarly to our patient with bleeding, malabsorption, dysmotility, and protein-losing gastroenteropathy as ascites, edema, pericardial effusions, and laboratory evidence of hypoalbuminemia.7 Because amyloidosis is a systemic illness, early recognition is important as intestinal complications tend to present as symptoms, but mortality is more often caused by renal failure, cardiomyopathy, or ischemic heart disease, making early multispecialty involvement very important.8
Conclusions
Health care practitioners in all specialties should be aware of and include intestinal amyloidosis in their differential diagnosis when working up GI bleeds with the hope of identifying the disease early. With early recognition, rapid biopsy identification, and early specialist involvement, patients will get the opportunity for expedited multidisciplinary treatment and potentially delay rapid decompensation as shown by the evidence in this case.
Gastrointestinal (GI) bleeding is a common cause of hospital admissions. The yearly incidence of upper GI bleeding is 80 to 150/100,000 people and lower GI bleeding is 87/100,000 people.1,2 The differential tends to initially be broad but narrows with good history followed by endoscopic findings. Getting an appropriate history can be difficult at times, which leads health care practitioners to rely more on interventional results.
Amyloidosis is a rare disorder of abnormal protein folding, leading to the deposition of insoluble fibrils that disrupt normal tissues and cause disease.3 There are 2 main types of amyloidosis, systemic and transthyretin, and 4 subtypes. Systemic amyloidosis includes amyloid light-chain (AL) deposition, caused by plasma cell dyscrasia, and amyloid A (AA) protein deposition, caused by systemic autoimmune illness or infections. Transthyretin amyloidosis is caused by changes and deposition of the transthyretin protein consisting of either unstable, mutant protein or wild type protein. Biopsy-proven amyloidosis of the GI tract is rare.4 About 60% of patients with AA amyloidosis and 8% with AL amyloidosis have GI involvement.5
We present a case of nonspecific symptoms that ultimately lined up perfectly with the official histologic confirmation of intestinal amyloidosis.
Case Presentation
A 79-year-old man with a history of type 2 diabetes mellitus, congestive heart failure, hyperlipidemia, obstructive sleep apnea, hypothyroidism, hypertension, coronary artery disease status postcoronary artery bypass grafting, and stent placements presented for 3 episodes of large, bright red bowel movements. He reported past bleeding and straining with stools, but bleeding of this amount had not been noted prior. He also reported dry heaves, lower abdominal pain, constipation with straining, early satiety with dysphagia, weakness, and decreased appetite. Lastly, he mentioned intentionally losing about 35 to 40 pounds in the past 3 to 4 months and over the past several months increased abdominal distention. However, he stated he had no history of alcohol misuse, liver or intestinal disease, cirrhosis, or other autoimmune diseases. His most recent colonoscopy was more than a decade prior and showed no acute process. The patient never had an esophagogastroduodenoscopy (EGD).
On initial presentation, the patient’s vital signs showed no acute findings. His physical examination noted a chronically ill–appearing male with decreased breath sounds to the bases bilaterally and noted abdominal distention with mild generalized tenderness. Laboratory findings were significant for a hemoglobin level, 9.4 g/dL (reference range, 11.6-15.3); iron, 23 ug/dL (reference range, 45-160); transferrin saturation, 8% (reference range, 15-50); ferritin level, 80 ng/mL (reference range, 30-300); and carcinoembryonic antigen level, 1.5 ng/mL (reference range, 0-2.9). Aspartate aminotransferase level was 54 IU/L (reference range, 0-40); alanine transaminase, 24 IU/L (reference range, 7-52); albumin, 2.7 g/dL (reference range, 3.4-5.7); international normalized ratio, 1.3 (reference range, 0-1.1); creatinine, 1.74 mg/dL (reference range, 0.44-1.27); alkaline phosphatase, 369 IU/L (reference range, 39-117). White blood cell count was 15.5 × 109/L (reference range, 3.5-10.3), and lactic acid was 2.5 mmol/L (reference range, 0.5-2.2). He was started on piperacillin/tazobactam in the emergency department and transitioned to ciprofloxacin and metronidazole for presumed intra-abdominal infection. Paracentesis showed a serum ascites albumin gradient of > 1.1 g/dL with no signs of spontaneous bacterial peritonitis. Computed tomography of the abdomen and pelvis with contrast was suspicious for colitis involving the proximal colon, and colonic mass could not be excluded. Also noted was hepatosplenomegaly with abdominopelvic ascites.
Based on these findings, an EGD and colonoscopy were done. The EGD showed mild portal hypertensive gastropathy.
After the biopsy results, the patient was officially diagnosed with intestinal amyloidosis (Figure 2).
He returned to the gastroenterology clinic 2 months later. At that point, he had worsening symptoms, liver function test results, and international normalized ratio. He was admitted for further investigation. A bone biopsy was done to confirm the histology and define the underlying disorder. The biopsy returned showing Waldenstrom macroglobulinemia, and he was started on bortezomib. Unfortunately, his clinical status rapidly worsened, leading to acute renal and hepatic failure and the development of encephalopathy. He eventually died under palliative care services.
Discussion
Amyloidosis is a rare disorder of abnormal protein folding, leading to the deposition of insoluble fibrils that disrupt normal tissues and cause disease.3 There are several variations of amyloid, but the most common type is AL amyloidosis, which affects several organs, including the heart, kidney, liver, nervous system, and GI tract. When AL amyloidosis involves the liver, the median survival time is about 8.5 months.6 There are different ways to diagnose the disease, but a tissue biopsy and Congo Red staining can confirm specific organ involvement as seen in our case.
This case adds another layer to our constantly expanding differential as health care practitioners and proves that atypical patient presentations may not be atypical after all. GI amyloidosis tends to present similarly to our patient with bleeding, malabsorption, dysmotility, and protein-losing gastroenteropathy as ascites, edema, pericardial effusions, and laboratory evidence of hypoalbuminemia.7 Because amyloidosis is a systemic illness, early recognition is important as intestinal complications tend to present as symptoms, but mortality is more often caused by renal failure, cardiomyopathy, or ischemic heart disease, making early multispecialty involvement very important.8
Conclusions
Health care practitioners in all specialties should be aware of and include intestinal amyloidosis in their differential diagnosis when working up GI bleeds with the hope of identifying the disease early. With early recognition, rapid biopsy identification, and early specialist involvement, patients will get the opportunity for expedited multidisciplinary treatment and potentially delay rapid decompensation as shown by the evidence in this case.
1. Antunes C, Copelin II EL. Upper gastrointestinal bleeding. StatPearls [internet]. Updated July 18, 2022. Accessed May 25, 2023. https://www.ncbi.nlm.nih.gov/books/NBK470300
2. Almaghrabi M, Gandhi M, Guizzetti L, et al. Comparison of risk scores for lower gastrointestinal bleeding: a systematic review and meta-analysis. JAMA Netw Open. 2022;5(5):e2214253. doi:10.1001/jamanetworkopen.2022.14253
3. Pepys MB. Pathogenesis, diagnosis and treatment of systemic amyloidosis. Philos Trans R Soc Lond B Biol Sci. 2001;356(1406):203-211. doi:10.1098/rstb.2000.0766
4. Cowan AJ, Skinner M, Seldin DC, et al. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013;98(1):141-146. doi:10.3324/haematol.2012.068155
5. Lee BS, Chudasama Y, Chen AI, Lim BS, Taira MT. Colonoscopy leading to the diagnosis of AL amyloidosis in the gastrointestinal tract mimicking an acute ulcerative colitis flare. ACG Case Rep J. 2019;6(11):e00289. doi:10.14309/crj.0000000000000289
6. Zhao L, Ren G, Guo J, Chen W, Xu W, Huang X. The clinical features and outcomes of systemic light chain amyloidosis with hepatic involvement. Ann Med. 2022;54(1):1226-1232. doi:10.1080/07853890.2022.2069281
7. Rowe K, Pankow J, Nehme F, Salyers W. Gastrointestinal amyloidosis: review of the literature. Cureus. 2017;9(5):e1228. doi:10.7759/cureus.1228
8. Kyle RA, Greipp PR, O’Fallon WM. Primary systemic amyloidosis: multivariate analysis for prognostic factors in 168 cases. Blood. 1986;68(1):220-224.
1. Antunes C, Copelin II EL. Upper gastrointestinal bleeding. StatPearls [internet]. Updated July 18, 2022. Accessed May 25, 2023. https://www.ncbi.nlm.nih.gov/books/NBK470300
2. Almaghrabi M, Gandhi M, Guizzetti L, et al. Comparison of risk scores for lower gastrointestinal bleeding: a systematic review and meta-analysis. JAMA Netw Open. 2022;5(5):e2214253. doi:10.1001/jamanetworkopen.2022.14253
3. Pepys MB. Pathogenesis, diagnosis and treatment of systemic amyloidosis. Philos Trans R Soc Lond B Biol Sci. 2001;356(1406):203-211. doi:10.1098/rstb.2000.0766
4. Cowan AJ, Skinner M, Seldin DC, et al. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013;98(1):141-146. doi:10.3324/haematol.2012.068155
5. Lee BS, Chudasama Y, Chen AI, Lim BS, Taira MT. Colonoscopy leading to the diagnosis of AL amyloidosis in the gastrointestinal tract mimicking an acute ulcerative colitis flare. ACG Case Rep J. 2019;6(11):e00289. doi:10.14309/crj.0000000000000289
6. Zhao L, Ren G, Guo J, Chen W, Xu W, Huang X. The clinical features and outcomes of systemic light chain amyloidosis with hepatic involvement. Ann Med. 2022;54(1):1226-1232. doi:10.1080/07853890.2022.2069281
7. Rowe K, Pankow J, Nehme F, Salyers W. Gastrointestinal amyloidosis: review of the literature. Cureus. 2017;9(5):e1228. doi:10.7759/cureus.1228
8. Kyle RA, Greipp PR, O’Fallon WM. Primary systemic amyloidosis: multivariate analysis for prognostic factors in 168 cases. Blood. 1986;68(1):220-224.
Implementing Smoking Cessation Telehealth Technologies Within the VHA: Lessons Learned
Health care systems need practical, scalable methods to reach patients and connect them to available, evidence-based resources. Ideally, these systems need to be resource nonintensive to deploy, maintain, and use. They should also be low cost, have a relative advantage to the organization, be sensitive to patient needs, use available resources, and have rigorous evidence regarding their effect on patient-centered outcomes.1,2 Phone service is one way to reach people that remains viable. More than 97% of Americans own a cellphone of some kind, and 40% still have a landline.3,4 One intervention that has been increasingly used in routine care settings is an interactive voice response (IVR) system that uses phones for connecting to patients.
IVR systems are a type of telehealth that provides information or adjunct health services through use of a telecommunication platform and information technologies.5 These systems are automated telephone systems that use prerecorded or text-to-speech–generated messages that allow respondents to provide and access information without a live agent.6 Text messaging (SMS) is another modality that can be used to asynchronously engage with participants. IVR systems have been used successfully for many health conditions and services, such as improving veterans’ adherence to continuous positive airway pressure, colorectal cancer screening, and cognitive behavioral therapy.7-10 By building on existing technology and infrastructure, IVR systems can be a cost-effective option for health care system services.
A 2016 Cochrane review of IVR systems for smoking cessation identified 7 studies.11 Although none used opt-out mechanisms (where individuals are automatically enrolled in programs until they decide not to participate) to engage people without an expressed motivation to quit, these interventions seemed safe and were promisingly effective. Among patients enrolled in primary care, a trial of an IVR system led to a higher quit rate: 18% vs 8%.12
In one study, patients in the emergency department, particularly older ones, preferred phone-based interventions over SMS.13 IVR-based proactive tobacco cessation systems are cost-effective and have been successfully used in the US Department of Veterans Affairs (VA).14,15 IVR systems using opt-out approaches are being studied, though their effectiveness in this setting has not been proven. The pros and cons of different interventions need to be explored since there is likely a tradeoff between feasibility and effectiveness. For example, intensive smoking cessation interventions are more effective but often require more resources to implement and sustain.16 Basing interventions that are not resource intensive within a reputable organizational system may amplify the effectiveness.17
This endeavor to establish an IVR system was initiated as part of our research study, a randomized trial of the Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention at the VA Portland Health Care System in Oregon. We measured the reach and effectiveness of a novel, proactive, resource nonintensive, and pragmatic intervention to engage veterans with a recently diagnosed lung nodule who smoke cigarettes.18 Our research team extracted the contact information for patients currently smoking and found to a have a pulmonary nodule from the VA Corporate Data Warehouse.19 We then manually uploaded those data to an IVR website where the system contacted patients to connect them to smoking cessation resources on an opt-out basis. In the research study, we measured the acceptability and effectiveness of the TeaM OUT intervention using quantitative and qualitative methods.
We developed and implemented an IVR system for use at 4 facilities: VA Portland Health Care System, Minneapolis VA Health Care System, Ralph H. Johnson VA Medical Center (Charleston, NC), and the Baltimore VA Medical Center. Setting up any type of wide-scale technology within the VA can be challenging. Due to our experience in developing and implementing the IVR system in the VA, we share what we have learned about the process of finding, contracting, developing, and implementing an IVR system. We share our experiences with developing and implementing this system to provide guidance for those who may want to establish an IVR system (or similar technologies) within the VA.
Lessons Learned
During our development and implementation process, we learned several lessons about setting up an IVR system in the VA. It is important to note that VA facilities may have differing processes, and policies frequently change; thus coordination with departments (eg, contracting, finance, Office of Information and Technology [OIT], etc) to verify the following strategies is essential (Figure).
Vendor Selection
Check with the local OIT and contracting offices to see if the facility has previously used any vendors for these services and for advice on selection. We compiled a list of questions that may be helpful based on our discussions with 4 vendors, prior to selection of a vendor already VA-approved (Appendix). There are also questions to think about in parallel with choosing a vendor. Contact your OIT, contracting, and privacy (if necessary) offices before choosing a vendor.
Online Security
After selecting a vendor, if you want an online portal to view, upload, or downloaddata, then you will need to initiate the single sign-on internal (SSOI) process (www.data.va.gov/dataset/Single-Sign-On-Internal-SSOi-/cber-kxf9). Other benefits of a website are to identify call patterns (eg, no one picks up after the 10th call) and track respondents’ selections. The SSOI process can take up to 1 year. Notably, the website login at minimum needs to be created by the IVR vendor to start the process. After the SSOI is approved you can add more to the website beyond just the login capability. Note that the script needs to be finalized prior to SSOI initiation. You will need to initiate with the SSOI team, then the vendor will need to complete the process.
Contracting
Concurrent with the above steps, contact the contracting office to get a sense of the paperwork and timeline. Make sure you are comfortable with the vendor’s responses to the questions in the Appendix, and view their written proposal or scope of work (SOW) to ensure they can do what the project protocol demands.
If the vendor has previously worked with the VA, contact your local contract office (usually part of the Finance Office) for updated forms. We needed the 6500.6 Checklist, Document Checklist for Service Requests, Single Source Justification, Research & Development Order (if research-related), and Vendor File Request forms. The vendor can help complete these forms. Review the proposal/SOW and budget first, knowing that budgets have a wide range and depend on the length and complexity of the script, number of calls, number of respondents, etc. For example, our quote was $110,000 over 4 years, including development, training, hosting on a secure server, and maintenance. Our IVR system will call about 5000 patients across 4 sites. Each patient will receive up to 15 calls over 2 weeks if they do not answer. We created 2 IVR lines (1 inbound and 1 outbound). Next, contact the lead of the local OIT and contracting departments by email to justify sharing veteran information with a contracted entity via approved methods. Finally, contact the privacy officer and information security officer. Discuss where software would be installed, whether cloud storage would be used, and what information can be shared/stored. Remember that the rules may differ for research vs nonresearch projects. Also, determine whether a data-use agreement between the VA and the vendor is needed and how the institutional review board (if research) gets integrated.
If using an outside vendor who has never worked with the VA, submit form 6550.6. Note that contracting requires several months. First, contact OIT and contracting departments. Again, you will need to justify sharing veteran information with a contracted entity. Next, complete the Project Special Forces Software and Privacy Threshold Analysis process to purchase the system. Set up a meeting with OIT to determine other forms and next steps. Business need/case use form and data security categorization may be needed. If the software needs to be installed on a VA computer, you will need to submit a Technical Reference Model request if it does not have an entry.
Vendors can answer technical questions from the contracting office, especially about the SOW, but the VA team needs to write the contract and manage all documentation and communication. You will also need sole source documentation (receive from contracting office) with justification for why you want to use a specific vendor. If you do not have that justification, in cooperation with the contracts office, you must solicit bids from other companies. Importantly, understand the staff support needed for contracting and build into your timeline and budget. Not surprisingly, we found that in-person or phone meetings were invaluable compared with email correspondence. Meet with all parties involved early and often. Once the contract is clear, this begins the build process where the vendor can program and record the script. This process usually takes 1 to 2 months.
Patient Engagement, Tracking, and Long-term Support
The new Patient Engagement, Tracking, and Long-term Support (PETALS) initiative is an excellent place to start with any VA IVR-related questions. PETALS is used for research.20 We hoped to use this system for our study, but its implementation was delayed until 2022. The PETALS system is designed for VA investigators who conduct research studies and need a secure platform that is compliant with VA policies for deploying SMS and IVR systems for research.20 At this time, PETALS is for use only with veterans, so if research will occur outside the VA, you must use an outside vendor. Users who want to set up a new IVR system can ask their local contracting office whether any contracts have already been established for IVR development and support.
From our perspective as researchers who are not telehealth savvy, we encountered several delays from failing to ask the appropriate questions or inability to navigate complicated systems. For instance, there were several tasks that needed to be completed and were not included in the original timeline developed by the vendor and researcher. Therefore, it is important to have clear communication on both sides about who is doing what, when, and how. We tried to detail these unexpected steps to help researchers, administrators, or other VA employees in the future.
Conclusions
IVR systems, once they are developed and implemented, can be efficient, low-cost, resource-nonintensive solutions in a health care setting that can effectively connect patients with needed health care services. Our experience developing an IVR system within the VA was challenging and was a huge learning curve for our research team. We hope that our experience and lessons will help VA personnel in the future.
Acknowledgments
Thank you to everyone involved in this project and who answered questions about the process, especially Nicolle Marinec, MPH; Toan Tran, and Molly Delorit, BA. This study and Christopher Slatore, MD, are supported by an award from the US Department of Veterans Affairs (HSR&D IIR 19-425). It was also supported by resources from the Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon (VAPORHCS).
1. Lewis CC, Mettert K, Lyon AR. Determining the influence of intervention characteristics on implementation success requires reliable and valid measures: results from a systematic review. Implement Res Pract. 2021;2:2633489521994197. doi:10.1177/2633489521994197
2. Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013;8:51. Published 2013 May 10. doi:10.1186/1748-5908-8-51
3. Pew Research Center. Mobile Fact Sheet. April 7, 2021. Accessed June 6, 2023. https://www.pewresearch.org/internet/fact-sheet/mobile/
4. Lieser EK. Study: Only 40 Percent of U.S. Households Have a Landline. The National Interest. March 20, 2020. Accessed June 6, 2023. https://nationalinterest.org/blog/buzz/study-only-40-percent-us-households-have-landline-135212
5. Lee H, Friedman ME, Cukor P, David Ahern. Interactive voice response system (IVRS) in health care services. Nurs Outlook. 2003;51(6):277-283. doi:10.1016/S0029-6554(03)00161-1
6. IBM Cloud Education. What is interactive voice response (IVR)? IBM. March 15, 2021. Accessed June 6, 2023. https://www.ibm.com/cloud/learn/interactive-voice-response
7. Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010;65(12):1061-1066. doi:10.1136/thx.2009.133215
8. Cohen-Cline H, Wernli KJ, Bradford SC, Boles-Hall M, Grossman DC. Use of interactive voice response to improve colorectal cancer screening. Med Care. 2014;52(6):496-499. doi:10.1097/MLR.0000000000000116
9. Graham J, Tomcavage J, Salek D, Sciandra J, Davis DE, Stewart WF. Postdischarge Monitoring Using Interactive Voice Response System Reduces 30-Day Readmission Rates in a Case-managed Medicare Population. Med Care. 2012;50(1):50-57. doi:10.1097/MLR.0b013e318229433e
10. Piette JD, Newman S, Krein SL, et al. Patient-centered pain care using artificial intelligence and mobile health tools: a randomized comparative effectiveness trial. JAMA Intern Med. 2022;182(9):975-83. doi:10.1001/jamainternmed.2022.3178
11. Posadzki P, Mastellos N, Ryan R, et al. Automated telephone communication systems for preventive healthcare and management of long-term conditions. Cochrane Database Syst Rev. 2016;12(12):CD009921. Published 2016 Dec 14. doi:10.1002/14651858.CD009921.pub2
12. Haas JS, Linder JA, Park ER, et al. Proactive tobacco cessation outreach to smokers of low socioeconomic status: A randomized clinical trial. JAMA Intern Med. 2015;175(2):218-226. doi:10.1001/jamainternmed.2014.6674
13. Fingrut W, Stewart L, Cheung KW. Choice of smoking cessation counselling via phone, text, or email in emergency department patients. Prev Med Rep. 2016;4:597-600. doi:10.1016/j.pmedr.2016.10.010
14. Levy DE, Klinger EV, Linder JA, et al. Cost-effectiveness of a health system-based smoking cessation program. Nicotine Tob Res. 2017;19(12):1508-1515. doi:10.1093/ntr/ntw243
15. Heapy AA, Higgins DM, LaChappelle KM, et al. Cooperative pain education and self-management (COPES): Study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC Musculoskelet Disord. 2016;17:85. doi:10.1186/s12891-016-0924-z
16. Chen D, Wu LT. Smoking cessation interventions for adults aged 50 or older: a systematic review and meta-analysis. Drug Alcohol Depend. 2015;154:14-24. doi:10.1016/j.drugalcdep.2015.06.004
17. Bennett-Levy J, Richards D, Farrand P, et al. Oxford Guide to Low Intensity CBT Interventions. 1st ed. Oxford University Press; 2010.
18. Unger S, Golden SE, Melzer AC, et al. Study design for a proactive teachable moment tobacco treatment intervention among patients with pulmonary nodules. Contemp Clin Trials. 2022;121:106908. doi:10.1016/j.cct.2022.106908
19. US Department of Veterans Affairs. VA Information Resource Center [Internet]. VIReC Research User Guides. 2016. https://www.virec.research.va.gov/Resources/RUGs.asp
20. PETALS. US Department of Veteran Affairs. Updated June 14, 2021. Accessed June 6, 2023. https://www.annarbor.hsrd.research.va.gov/ANNARBORHSRDRESEARCH/PETALS.asp
Health care systems need practical, scalable methods to reach patients and connect them to available, evidence-based resources. Ideally, these systems need to be resource nonintensive to deploy, maintain, and use. They should also be low cost, have a relative advantage to the organization, be sensitive to patient needs, use available resources, and have rigorous evidence regarding their effect on patient-centered outcomes.1,2 Phone service is one way to reach people that remains viable. More than 97% of Americans own a cellphone of some kind, and 40% still have a landline.3,4 One intervention that has been increasingly used in routine care settings is an interactive voice response (IVR) system that uses phones for connecting to patients.
IVR systems are a type of telehealth that provides information or adjunct health services through use of a telecommunication platform and information technologies.5 These systems are automated telephone systems that use prerecorded or text-to-speech–generated messages that allow respondents to provide and access information without a live agent.6 Text messaging (SMS) is another modality that can be used to asynchronously engage with participants. IVR systems have been used successfully for many health conditions and services, such as improving veterans’ adherence to continuous positive airway pressure, colorectal cancer screening, and cognitive behavioral therapy.7-10 By building on existing technology and infrastructure, IVR systems can be a cost-effective option for health care system services.
A 2016 Cochrane review of IVR systems for smoking cessation identified 7 studies.11 Although none used opt-out mechanisms (where individuals are automatically enrolled in programs until they decide not to participate) to engage people without an expressed motivation to quit, these interventions seemed safe and were promisingly effective. Among patients enrolled in primary care, a trial of an IVR system led to a higher quit rate: 18% vs 8%.12
In one study, patients in the emergency department, particularly older ones, preferred phone-based interventions over SMS.13 IVR-based proactive tobacco cessation systems are cost-effective and have been successfully used in the US Department of Veterans Affairs (VA).14,15 IVR systems using opt-out approaches are being studied, though their effectiveness in this setting has not been proven. The pros and cons of different interventions need to be explored since there is likely a tradeoff between feasibility and effectiveness. For example, intensive smoking cessation interventions are more effective but often require more resources to implement and sustain.16 Basing interventions that are not resource intensive within a reputable organizational system may amplify the effectiveness.17
This endeavor to establish an IVR system was initiated as part of our research study, a randomized trial of the Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention at the VA Portland Health Care System in Oregon. We measured the reach and effectiveness of a novel, proactive, resource nonintensive, and pragmatic intervention to engage veterans with a recently diagnosed lung nodule who smoke cigarettes.18 Our research team extracted the contact information for patients currently smoking and found to a have a pulmonary nodule from the VA Corporate Data Warehouse.19 We then manually uploaded those data to an IVR website where the system contacted patients to connect them to smoking cessation resources on an opt-out basis. In the research study, we measured the acceptability and effectiveness of the TeaM OUT intervention using quantitative and qualitative methods.
We developed and implemented an IVR system for use at 4 facilities: VA Portland Health Care System, Minneapolis VA Health Care System, Ralph H. Johnson VA Medical Center (Charleston, NC), and the Baltimore VA Medical Center. Setting up any type of wide-scale technology within the VA can be challenging. Due to our experience in developing and implementing the IVR system in the VA, we share what we have learned about the process of finding, contracting, developing, and implementing an IVR system. We share our experiences with developing and implementing this system to provide guidance for those who may want to establish an IVR system (or similar technologies) within the VA.
Lessons Learned
During our development and implementation process, we learned several lessons about setting up an IVR system in the VA. It is important to note that VA facilities may have differing processes, and policies frequently change; thus coordination with departments (eg, contracting, finance, Office of Information and Technology [OIT], etc) to verify the following strategies is essential (Figure).
Vendor Selection
Check with the local OIT and contracting offices to see if the facility has previously used any vendors for these services and for advice on selection. We compiled a list of questions that may be helpful based on our discussions with 4 vendors, prior to selection of a vendor already VA-approved (Appendix). There are also questions to think about in parallel with choosing a vendor. Contact your OIT, contracting, and privacy (if necessary) offices before choosing a vendor.
Online Security
After selecting a vendor, if you want an online portal to view, upload, or downloaddata, then you will need to initiate the single sign-on internal (SSOI) process (www.data.va.gov/dataset/Single-Sign-On-Internal-SSOi-/cber-kxf9). Other benefits of a website are to identify call patterns (eg, no one picks up after the 10th call) and track respondents’ selections. The SSOI process can take up to 1 year. Notably, the website login at minimum needs to be created by the IVR vendor to start the process. After the SSOI is approved you can add more to the website beyond just the login capability. Note that the script needs to be finalized prior to SSOI initiation. You will need to initiate with the SSOI team, then the vendor will need to complete the process.
Contracting
Concurrent with the above steps, contact the contracting office to get a sense of the paperwork and timeline. Make sure you are comfortable with the vendor’s responses to the questions in the Appendix, and view their written proposal or scope of work (SOW) to ensure they can do what the project protocol demands.
If the vendor has previously worked with the VA, contact your local contract office (usually part of the Finance Office) for updated forms. We needed the 6500.6 Checklist, Document Checklist for Service Requests, Single Source Justification, Research & Development Order (if research-related), and Vendor File Request forms. The vendor can help complete these forms. Review the proposal/SOW and budget first, knowing that budgets have a wide range and depend on the length and complexity of the script, number of calls, number of respondents, etc. For example, our quote was $110,000 over 4 years, including development, training, hosting on a secure server, and maintenance. Our IVR system will call about 5000 patients across 4 sites. Each patient will receive up to 15 calls over 2 weeks if they do not answer. We created 2 IVR lines (1 inbound and 1 outbound). Next, contact the lead of the local OIT and contracting departments by email to justify sharing veteran information with a contracted entity via approved methods. Finally, contact the privacy officer and information security officer. Discuss where software would be installed, whether cloud storage would be used, and what information can be shared/stored. Remember that the rules may differ for research vs nonresearch projects. Also, determine whether a data-use agreement between the VA and the vendor is needed and how the institutional review board (if research) gets integrated.
If using an outside vendor who has never worked with the VA, submit form 6550.6. Note that contracting requires several months. First, contact OIT and contracting departments. Again, you will need to justify sharing veteran information with a contracted entity. Next, complete the Project Special Forces Software and Privacy Threshold Analysis process to purchase the system. Set up a meeting with OIT to determine other forms and next steps. Business need/case use form and data security categorization may be needed. If the software needs to be installed on a VA computer, you will need to submit a Technical Reference Model request if it does not have an entry.
Vendors can answer technical questions from the contracting office, especially about the SOW, but the VA team needs to write the contract and manage all documentation and communication. You will also need sole source documentation (receive from contracting office) with justification for why you want to use a specific vendor. If you do not have that justification, in cooperation with the contracts office, you must solicit bids from other companies. Importantly, understand the staff support needed for contracting and build into your timeline and budget. Not surprisingly, we found that in-person or phone meetings were invaluable compared with email correspondence. Meet with all parties involved early and often. Once the contract is clear, this begins the build process where the vendor can program and record the script. This process usually takes 1 to 2 months.
Patient Engagement, Tracking, and Long-term Support
The new Patient Engagement, Tracking, and Long-term Support (PETALS) initiative is an excellent place to start with any VA IVR-related questions. PETALS is used for research.20 We hoped to use this system for our study, but its implementation was delayed until 2022. The PETALS system is designed for VA investigators who conduct research studies and need a secure platform that is compliant with VA policies for deploying SMS and IVR systems for research.20 At this time, PETALS is for use only with veterans, so if research will occur outside the VA, you must use an outside vendor. Users who want to set up a new IVR system can ask their local contracting office whether any contracts have already been established for IVR development and support.
From our perspective as researchers who are not telehealth savvy, we encountered several delays from failing to ask the appropriate questions or inability to navigate complicated systems. For instance, there were several tasks that needed to be completed and were not included in the original timeline developed by the vendor and researcher. Therefore, it is important to have clear communication on both sides about who is doing what, when, and how. We tried to detail these unexpected steps to help researchers, administrators, or other VA employees in the future.
Conclusions
IVR systems, once they are developed and implemented, can be efficient, low-cost, resource-nonintensive solutions in a health care setting that can effectively connect patients with needed health care services. Our experience developing an IVR system within the VA was challenging and was a huge learning curve for our research team. We hope that our experience and lessons will help VA personnel in the future.
Acknowledgments
Thank you to everyone involved in this project and who answered questions about the process, especially Nicolle Marinec, MPH; Toan Tran, and Molly Delorit, BA. This study and Christopher Slatore, MD, are supported by an award from the US Department of Veterans Affairs (HSR&D IIR 19-425). It was also supported by resources from the Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon (VAPORHCS).
Health care systems need practical, scalable methods to reach patients and connect them to available, evidence-based resources. Ideally, these systems need to be resource nonintensive to deploy, maintain, and use. They should also be low cost, have a relative advantage to the organization, be sensitive to patient needs, use available resources, and have rigorous evidence regarding their effect on patient-centered outcomes.1,2 Phone service is one way to reach people that remains viable. More than 97% of Americans own a cellphone of some kind, and 40% still have a landline.3,4 One intervention that has been increasingly used in routine care settings is an interactive voice response (IVR) system that uses phones for connecting to patients.
IVR systems are a type of telehealth that provides information or adjunct health services through use of a telecommunication platform and information technologies.5 These systems are automated telephone systems that use prerecorded or text-to-speech–generated messages that allow respondents to provide and access information without a live agent.6 Text messaging (SMS) is another modality that can be used to asynchronously engage with participants. IVR systems have been used successfully for many health conditions and services, such as improving veterans’ adherence to continuous positive airway pressure, colorectal cancer screening, and cognitive behavioral therapy.7-10 By building on existing technology and infrastructure, IVR systems can be a cost-effective option for health care system services.
A 2016 Cochrane review of IVR systems for smoking cessation identified 7 studies.11 Although none used opt-out mechanisms (where individuals are automatically enrolled in programs until they decide not to participate) to engage people without an expressed motivation to quit, these interventions seemed safe and were promisingly effective. Among patients enrolled in primary care, a trial of an IVR system led to a higher quit rate: 18% vs 8%.12
In one study, patients in the emergency department, particularly older ones, preferred phone-based interventions over SMS.13 IVR-based proactive tobacco cessation systems are cost-effective and have been successfully used in the US Department of Veterans Affairs (VA).14,15 IVR systems using opt-out approaches are being studied, though their effectiveness in this setting has not been proven. The pros and cons of different interventions need to be explored since there is likely a tradeoff between feasibility and effectiveness. For example, intensive smoking cessation interventions are more effective but often require more resources to implement and sustain.16 Basing interventions that are not resource intensive within a reputable organizational system may amplify the effectiveness.17
This endeavor to establish an IVR system was initiated as part of our research study, a randomized trial of the Teachable Moment to Opt-Out of Tobacco (TeaM OUT) intervention at the VA Portland Health Care System in Oregon. We measured the reach and effectiveness of a novel, proactive, resource nonintensive, and pragmatic intervention to engage veterans with a recently diagnosed lung nodule who smoke cigarettes.18 Our research team extracted the contact information for patients currently smoking and found to a have a pulmonary nodule from the VA Corporate Data Warehouse.19 We then manually uploaded those data to an IVR website where the system contacted patients to connect them to smoking cessation resources on an opt-out basis. In the research study, we measured the acceptability and effectiveness of the TeaM OUT intervention using quantitative and qualitative methods.
We developed and implemented an IVR system for use at 4 facilities: VA Portland Health Care System, Minneapolis VA Health Care System, Ralph H. Johnson VA Medical Center (Charleston, NC), and the Baltimore VA Medical Center. Setting up any type of wide-scale technology within the VA can be challenging. Due to our experience in developing and implementing the IVR system in the VA, we share what we have learned about the process of finding, contracting, developing, and implementing an IVR system. We share our experiences with developing and implementing this system to provide guidance for those who may want to establish an IVR system (or similar technologies) within the VA.
Lessons Learned
During our development and implementation process, we learned several lessons about setting up an IVR system in the VA. It is important to note that VA facilities may have differing processes, and policies frequently change; thus coordination with departments (eg, contracting, finance, Office of Information and Technology [OIT], etc) to verify the following strategies is essential (Figure).
Vendor Selection
Check with the local OIT and contracting offices to see if the facility has previously used any vendors for these services and for advice on selection. We compiled a list of questions that may be helpful based on our discussions with 4 vendors, prior to selection of a vendor already VA-approved (Appendix). There are also questions to think about in parallel with choosing a vendor. Contact your OIT, contracting, and privacy (if necessary) offices before choosing a vendor.
Online Security
After selecting a vendor, if you want an online portal to view, upload, or downloaddata, then you will need to initiate the single sign-on internal (SSOI) process (www.data.va.gov/dataset/Single-Sign-On-Internal-SSOi-/cber-kxf9). Other benefits of a website are to identify call patterns (eg, no one picks up after the 10th call) and track respondents’ selections. The SSOI process can take up to 1 year. Notably, the website login at minimum needs to be created by the IVR vendor to start the process. After the SSOI is approved you can add more to the website beyond just the login capability. Note that the script needs to be finalized prior to SSOI initiation. You will need to initiate with the SSOI team, then the vendor will need to complete the process.
Contracting
Concurrent with the above steps, contact the contracting office to get a sense of the paperwork and timeline. Make sure you are comfortable with the vendor’s responses to the questions in the Appendix, and view their written proposal or scope of work (SOW) to ensure they can do what the project protocol demands.
If the vendor has previously worked with the VA, contact your local contract office (usually part of the Finance Office) for updated forms. We needed the 6500.6 Checklist, Document Checklist for Service Requests, Single Source Justification, Research & Development Order (if research-related), and Vendor File Request forms. The vendor can help complete these forms. Review the proposal/SOW and budget first, knowing that budgets have a wide range and depend on the length and complexity of the script, number of calls, number of respondents, etc. For example, our quote was $110,000 over 4 years, including development, training, hosting on a secure server, and maintenance. Our IVR system will call about 5000 patients across 4 sites. Each patient will receive up to 15 calls over 2 weeks if they do not answer. We created 2 IVR lines (1 inbound and 1 outbound). Next, contact the lead of the local OIT and contracting departments by email to justify sharing veteran information with a contracted entity via approved methods. Finally, contact the privacy officer and information security officer. Discuss where software would be installed, whether cloud storage would be used, and what information can be shared/stored. Remember that the rules may differ for research vs nonresearch projects. Also, determine whether a data-use agreement between the VA and the vendor is needed and how the institutional review board (if research) gets integrated.
If using an outside vendor who has never worked with the VA, submit form 6550.6. Note that contracting requires several months. First, contact OIT and contracting departments. Again, you will need to justify sharing veteran information with a contracted entity. Next, complete the Project Special Forces Software and Privacy Threshold Analysis process to purchase the system. Set up a meeting with OIT to determine other forms and next steps. Business need/case use form and data security categorization may be needed. If the software needs to be installed on a VA computer, you will need to submit a Technical Reference Model request if it does not have an entry.
Vendors can answer technical questions from the contracting office, especially about the SOW, but the VA team needs to write the contract and manage all documentation and communication. You will also need sole source documentation (receive from contracting office) with justification for why you want to use a specific vendor. If you do not have that justification, in cooperation with the contracts office, you must solicit bids from other companies. Importantly, understand the staff support needed for contracting and build into your timeline and budget. Not surprisingly, we found that in-person or phone meetings were invaluable compared with email correspondence. Meet with all parties involved early and often. Once the contract is clear, this begins the build process where the vendor can program and record the script. This process usually takes 1 to 2 months.
Patient Engagement, Tracking, and Long-term Support
The new Patient Engagement, Tracking, and Long-term Support (PETALS) initiative is an excellent place to start with any VA IVR-related questions. PETALS is used for research.20 We hoped to use this system for our study, but its implementation was delayed until 2022. The PETALS system is designed for VA investigators who conduct research studies and need a secure platform that is compliant with VA policies for deploying SMS and IVR systems for research.20 At this time, PETALS is for use only with veterans, so if research will occur outside the VA, you must use an outside vendor. Users who want to set up a new IVR system can ask their local contracting office whether any contracts have already been established for IVR development and support.
From our perspective as researchers who are not telehealth savvy, we encountered several delays from failing to ask the appropriate questions or inability to navigate complicated systems. For instance, there were several tasks that needed to be completed and were not included in the original timeline developed by the vendor and researcher. Therefore, it is important to have clear communication on both sides about who is doing what, when, and how. We tried to detail these unexpected steps to help researchers, administrators, or other VA employees in the future.
Conclusions
IVR systems, once they are developed and implemented, can be efficient, low-cost, resource-nonintensive solutions in a health care setting that can effectively connect patients with needed health care services. Our experience developing an IVR system within the VA was challenging and was a huge learning curve for our research team. We hope that our experience and lessons will help VA personnel in the future.
Acknowledgments
Thank you to everyone involved in this project and who answered questions about the process, especially Nicolle Marinec, MPH; Toan Tran, and Molly Delorit, BA. This study and Christopher Slatore, MD, are supported by an award from the US Department of Veterans Affairs (HSR&D IIR 19-425). It was also supported by resources from the Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon (VAPORHCS).
1. Lewis CC, Mettert K, Lyon AR. Determining the influence of intervention characteristics on implementation success requires reliable and valid measures: results from a systematic review. Implement Res Pract. 2021;2:2633489521994197. doi:10.1177/2633489521994197
2. Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013;8:51. Published 2013 May 10. doi:10.1186/1748-5908-8-51
3. Pew Research Center. Mobile Fact Sheet. April 7, 2021. Accessed June 6, 2023. https://www.pewresearch.org/internet/fact-sheet/mobile/
4. Lieser EK. Study: Only 40 Percent of U.S. Households Have a Landline. The National Interest. March 20, 2020. Accessed June 6, 2023. https://nationalinterest.org/blog/buzz/study-only-40-percent-us-households-have-landline-135212
5. Lee H, Friedman ME, Cukor P, David Ahern. Interactive voice response system (IVRS) in health care services. Nurs Outlook. 2003;51(6):277-283. doi:10.1016/S0029-6554(03)00161-1
6. IBM Cloud Education. What is interactive voice response (IVR)? IBM. March 15, 2021. Accessed June 6, 2023. https://www.ibm.com/cloud/learn/interactive-voice-response
7. Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010;65(12):1061-1066. doi:10.1136/thx.2009.133215
8. Cohen-Cline H, Wernli KJ, Bradford SC, Boles-Hall M, Grossman DC. Use of interactive voice response to improve colorectal cancer screening. Med Care. 2014;52(6):496-499. doi:10.1097/MLR.0000000000000116
9. Graham J, Tomcavage J, Salek D, Sciandra J, Davis DE, Stewart WF. Postdischarge Monitoring Using Interactive Voice Response System Reduces 30-Day Readmission Rates in a Case-managed Medicare Population. Med Care. 2012;50(1):50-57. doi:10.1097/MLR.0b013e318229433e
10. Piette JD, Newman S, Krein SL, et al. Patient-centered pain care using artificial intelligence and mobile health tools: a randomized comparative effectiveness trial. JAMA Intern Med. 2022;182(9):975-83. doi:10.1001/jamainternmed.2022.3178
11. Posadzki P, Mastellos N, Ryan R, et al. Automated telephone communication systems for preventive healthcare and management of long-term conditions. Cochrane Database Syst Rev. 2016;12(12):CD009921. Published 2016 Dec 14. doi:10.1002/14651858.CD009921.pub2
12. Haas JS, Linder JA, Park ER, et al. Proactive tobacco cessation outreach to smokers of low socioeconomic status: A randomized clinical trial. JAMA Intern Med. 2015;175(2):218-226. doi:10.1001/jamainternmed.2014.6674
13. Fingrut W, Stewart L, Cheung KW. Choice of smoking cessation counselling via phone, text, or email in emergency department patients. Prev Med Rep. 2016;4:597-600. doi:10.1016/j.pmedr.2016.10.010
14. Levy DE, Klinger EV, Linder JA, et al. Cost-effectiveness of a health system-based smoking cessation program. Nicotine Tob Res. 2017;19(12):1508-1515. doi:10.1093/ntr/ntw243
15. Heapy AA, Higgins DM, LaChappelle KM, et al. Cooperative pain education and self-management (COPES): Study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC Musculoskelet Disord. 2016;17:85. doi:10.1186/s12891-016-0924-z
16. Chen D, Wu LT. Smoking cessation interventions for adults aged 50 or older: a systematic review and meta-analysis. Drug Alcohol Depend. 2015;154:14-24. doi:10.1016/j.drugalcdep.2015.06.004
17. Bennett-Levy J, Richards D, Farrand P, et al. Oxford Guide to Low Intensity CBT Interventions. 1st ed. Oxford University Press; 2010.
18. Unger S, Golden SE, Melzer AC, et al. Study design for a proactive teachable moment tobacco treatment intervention among patients with pulmonary nodules. Contemp Clin Trials. 2022;121:106908. doi:10.1016/j.cct.2022.106908
19. US Department of Veterans Affairs. VA Information Resource Center [Internet]. VIReC Research User Guides. 2016. https://www.virec.research.va.gov/Resources/RUGs.asp
20. PETALS. US Department of Veteran Affairs. Updated June 14, 2021. Accessed June 6, 2023. https://www.annarbor.hsrd.research.va.gov/ANNARBORHSRDRESEARCH/PETALS.asp
1. Lewis CC, Mettert K, Lyon AR. Determining the influence of intervention characteristics on implementation success requires reliable and valid measures: results from a systematic review. Implement Res Pract. 2021;2:2633489521994197. doi:10.1177/2633489521994197
2. Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013;8:51. Published 2013 May 10. doi:10.1186/1748-5908-8-51
3. Pew Research Center. Mobile Fact Sheet. April 7, 2021. Accessed June 6, 2023. https://www.pewresearch.org/internet/fact-sheet/mobile/
4. Lieser EK. Study: Only 40 Percent of U.S. Households Have a Landline. The National Interest. March 20, 2020. Accessed June 6, 2023. https://nationalinterest.org/blog/buzz/study-only-40-percent-us-households-have-landline-135212
5. Lee H, Friedman ME, Cukor P, David Ahern. Interactive voice response system (IVRS) in health care services. Nurs Outlook. 2003;51(6):277-283. doi:10.1016/S0029-6554(03)00161-1
6. IBM Cloud Education. What is interactive voice response (IVR)? IBM. March 15, 2021. Accessed June 6, 2023. https://www.ibm.com/cloud/learn/interactive-voice-response
7. Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010;65(12):1061-1066. doi:10.1136/thx.2009.133215
8. Cohen-Cline H, Wernli KJ, Bradford SC, Boles-Hall M, Grossman DC. Use of interactive voice response to improve colorectal cancer screening. Med Care. 2014;52(6):496-499. doi:10.1097/MLR.0000000000000116
9. Graham J, Tomcavage J, Salek D, Sciandra J, Davis DE, Stewart WF. Postdischarge Monitoring Using Interactive Voice Response System Reduces 30-Day Readmission Rates in a Case-managed Medicare Population. Med Care. 2012;50(1):50-57. doi:10.1097/MLR.0b013e318229433e
10. Piette JD, Newman S, Krein SL, et al. Patient-centered pain care using artificial intelligence and mobile health tools: a randomized comparative effectiveness trial. JAMA Intern Med. 2022;182(9):975-83. doi:10.1001/jamainternmed.2022.3178
11. Posadzki P, Mastellos N, Ryan R, et al. Automated telephone communication systems for preventive healthcare and management of long-term conditions. Cochrane Database Syst Rev. 2016;12(12):CD009921. Published 2016 Dec 14. doi:10.1002/14651858.CD009921.pub2
12. Haas JS, Linder JA, Park ER, et al. Proactive tobacco cessation outreach to smokers of low socioeconomic status: A randomized clinical trial. JAMA Intern Med. 2015;175(2):218-226. doi:10.1001/jamainternmed.2014.6674
13. Fingrut W, Stewart L, Cheung KW. Choice of smoking cessation counselling via phone, text, or email in emergency department patients. Prev Med Rep. 2016;4:597-600. doi:10.1016/j.pmedr.2016.10.010
14. Levy DE, Klinger EV, Linder JA, et al. Cost-effectiveness of a health system-based smoking cessation program. Nicotine Tob Res. 2017;19(12):1508-1515. doi:10.1093/ntr/ntw243
15. Heapy AA, Higgins DM, LaChappelle KM, et al. Cooperative pain education and self-management (COPES): Study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC Musculoskelet Disord. 2016;17:85. doi:10.1186/s12891-016-0924-z
16. Chen D, Wu LT. Smoking cessation interventions for adults aged 50 or older: a systematic review and meta-analysis. Drug Alcohol Depend. 2015;154:14-24. doi:10.1016/j.drugalcdep.2015.06.004
17. Bennett-Levy J, Richards D, Farrand P, et al. Oxford Guide to Low Intensity CBT Interventions. 1st ed. Oxford University Press; 2010.
18. Unger S, Golden SE, Melzer AC, et al. Study design for a proactive teachable moment tobacco treatment intervention among patients with pulmonary nodules. Contemp Clin Trials. 2022;121:106908. doi:10.1016/j.cct.2022.106908
19. US Department of Veterans Affairs. VA Information Resource Center [Internet]. VIReC Research User Guides. 2016. https://www.virec.research.va.gov/Resources/RUGs.asp
20. PETALS. US Department of Veteran Affairs. Updated June 14, 2021. Accessed June 6, 2023. https://www.annarbor.hsrd.research.va.gov/ANNARBORHSRDRESEARCH/PETALS.asp