There is a rich science around the management of the cirrhotic liver itself – for example, pragmatic prognostic markers such as MELDNa, data-driven strategies to prevent variceal bleeding, and well-utilized algorithms to manage ascites.

But what is new in cirrhosis management is an emerging science around the management of the person living with cirrhosis – a science that seeks to understand how these individuals function in their day-to-day lives, how they feel, and how they can best prepare for their future. What is so exciting is that the field is moving beyond simply understanding those complex aspects of the patient, which is important in and of itself, toward developing practical tools to help clinicians assess their patients’ symptoms and strategies to help improve their patients’ lived experience. Although terms such as “frailty,” “palliative care,” and “advance care planning” are not new in cirrhosis per se, they are now recognized as distinct patient-centered constructs that are highly relevant to the management of patients with cirrhosis. Furthermore, these constructs have been codified through two recent guidance statements sponsored by the American Association for the Study of Liver Diseases.^1,2 Pragmatic tools are emerging to facilitate the integration of these patient-centered constructs into routine clinical practice, tools such as the Liver Frailty Index, the Edmonton Symptom Assessment System adapted for patients with cirrhosis, and structured frameworks for guiding goals-of-care discussions. The incorporation of these tools allows for new management strategies directed toward improving the patient’s experience such as timely initiation of nutrition and activity-based interventions, algorithms for pharmacologic and nonpharmacologic strategies for symptom management, and online/video-guided approaches to articulating one’s goals of care.

So, what is new in cirrhosis management is that we are moving beyond managing the cirrhotic liver itself to considering how cirrhosis and its complications impact the patient as a whole. In doing so, we are turning the art of hepatology care into science that can be applied systematically at the bedside for every patient, with the goal of improving care for all patients living with cirrhosis.
 

Dr. Lai holds the Endowed Professorship of Liver Health and Transplantation at the University of California, San Francisco. She reports having no conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

References

1. Lai JC et al. Hepatology. 2021 Sep;74(3):1611-44.

2. Rogal S et al. Hepatology. 2022 Feb 1. doi: 10.1002/hep.32378.

There is a rich science around the management of the cirrhotic liver itself – for example, pragmatic prognostic markers such as MELDNa, data-driven strategies to prevent variceal bleeding, and well-utilized algorithms to manage ascites.

But what is new in cirrhosis management is an emerging science around the management of the person living with cirrhosis – a science that seeks to understand how these individuals function in their day-to-day lives, how they feel, and how they can best prepare for their future. What is so exciting is that the field is moving beyond simply understanding those complex aspects of the patient, which is important in and of itself, toward developing practical tools to help clinicians assess their patients’ symptoms and strategies to help improve their patients’ lived experience. Although terms such as “frailty,” “palliative care,” and “advance care planning” are not new in cirrhosis per se, they are now recognized as distinct patient-centered constructs that are highly relevant to the management of patients with cirrhosis. Furthermore, these constructs have been codified through two recent guidance statements sponsored by the American Association for the Study of Liver Diseases.^1,2 Pragmatic tools are emerging to facilitate the integration of these patient-centered constructs into routine clinical practice, tools such as the Liver Frailty Index, the Edmonton Symptom Assessment System adapted for patients with cirrhosis, and structured frameworks for guiding goals-of-care discussions. The incorporation of these tools allows for new management strategies directed toward improving the patient’s experience such as timely initiation of nutrition and activity-based interventions, algorithms for pharmacologic and nonpharmacologic strategies for symptom management, and online/video-guided approaches to articulating one’s goals of care.

So, what is new in cirrhosis management is that we are moving beyond managing the cirrhotic liver itself to considering how cirrhosis and its complications impact the patient as a whole. In doing so, we are turning the art of hepatology care into science that can be applied systematically at the bedside for every patient, with the goal of improving care for all patients living with cirrhosis.
 

Dr. Lai holds the Endowed Professorship of Liver Health and Transplantation at the University of California, San Francisco. She reports having no conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

References

1. Lai JC et al. Hepatology. 2021 Sep;74(3):1611-44.

2. Rogal S et al. Hepatology. 2022 Feb 1. doi: 10.1002/hep.32378.

There is a rich science around the management of the cirrhotic liver itself – for example, pragmatic prognostic markers such as MELDNa, data-driven strategies to prevent variceal bleeding, and well-utilized algorithms to manage ascites.

But what is new in cirrhosis management is an emerging science around the management of the person living with cirrhosis – a science that seeks to understand how these individuals function in their day-to-day lives, how they feel, and how they can best prepare for their future. What is so exciting is that the field is moving beyond simply understanding those complex aspects of the patient, which is important in and of itself, toward developing practical tools to help clinicians assess their patients’ symptoms and strategies to help improve their patients’ lived experience. Although terms such as “frailty,” “palliative care,” and “advance care planning” are not new in cirrhosis per se, they are now recognized as distinct patient-centered constructs that are highly relevant to the management of patients with cirrhosis. Furthermore, these constructs have been codified through two recent guidance statements sponsored by the American Association for the Study of Liver Diseases.^1,2 Pragmatic tools are emerging to facilitate the integration of these patient-centered constructs into routine clinical practice, tools such as the Liver Frailty Index, the Edmonton Symptom Assessment System adapted for patients with cirrhosis, and structured frameworks for guiding goals-of-care discussions. The incorporation of these tools allows for new management strategies directed toward improving the patient’s experience such as timely initiation of nutrition and activity-based interventions, algorithms for pharmacologic and nonpharmacologic strategies for symptom management, and online/video-guided approaches to articulating one’s goals of care.

So, what is new in cirrhosis management is that we are moving beyond managing the cirrhotic liver itself to considering how cirrhosis and its complications impact the patient as a whole. In doing so, we are turning the art of hepatology care into science that can be applied systematically at the bedside for every patient, with the goal of improving care for all patients living with cirrhosis.
 

Dr. Lai holds the Endowed Professorship of Liver Health and Transplantation at the University of California, San Francisco. She reports having no conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

References

1. Lai JC et al. Hepatology. 2021 Sep;74(3):1611-44.

2. Rogal S et al. Hepatology. 2022 Feb 1. doi: 10.1002/hep.32378.

Barrett’s esophagus (BE) is the only known precursor of esophageal adenocarcinoma (EAC). The rationale for early detection of BE rests on the premise that, after the diagnosis of BE, patients can be placed under endoscopic surveillance to detect prevalent and incident dysplasia and EAC. Randomized controlled trials have demonstrated that endoscopic eradication therapy (EET) of low-grade dysplasia (LGD) and high-grade dysplasia (HGD) can reduce progression to EAC. Guidelines support endoscopic screening for BE in those with multiple (three or more) risk factors.

However, endoscopy is expensive, invasive, and not widely utilized (less than 10% of those eligible are screened). Most patients with BE are unaware of their diagnosis and hence not under surveillance. Nonendoscopic techniques of BE detection – swallowed cell collection devices providing rich esophageal cytology specimens combined with biomarkers – are being developed. Case-control studies have shown promising accuracy and a recent UK pragmatic primary care study showed the ability of this technology to increase BE detection safely.

Detection of dysplasia in endoscopic surveillance is critical and the neoplasia detection rate (NDR) has been recently proposed as a quality marker. The NDR is the ratio of HGD+EAC detected to all patients with BE undergoing their first surveillance endoscopy. A recent systematic review and meta-analysis showed an inverse association between NDR and postendoscopy BE neoplasia. Additional and prospective studies are required to further correlate NDR values to clinically relevant outcomes similar to the association between adenoma detection rate and postcolonoscopy colorectal cancer.

Detection of dysplasia with endoscopic surveillance is challenging because of sampling error inherent in the Seattle protocol. A recent technology, Wide Area Transepithelial Sampling–3D (WATS), combines the concept of increased sampling of the BE mucosa by using a stiff endoscopic brush followed by use of artificial intelligence neural network enabled selection of abnormal cells, which are presented to a pathologist. This technology has been shown to increase dysplasia and HGD detection, compared to endoscopic surveillance, in a systematic review and meta-analysis. However, WATS is negative in a substantial proportion of cases in which endoscopic Seattle protocol reveals dysplasia. In addition, only limited data are available on the natural history of WATS LGD or HGD. Confirmation of WATS-only dysplasia (LGD, HGD, or EAC) by endoscopic histology is also recommended before the institution of EET. Finally, assessment of progression risk in those with BE is critical to enable more personalized follow up recommendations. Clinical risk scores integrating age, sex, smoking history, and LGD have been proposed and validated. A recent tissue systems pathology test has been shown in multiple case-control studies to identify a subset of BE patients who are at higher risk of progression, independent of LGD. This test is highly specific but only modestly sensitive in identifying progressors.

Dr. Iyer is professor of medicine, director of the Esophageal Interest Group, and codirector of the Advanced Esophageal Fellowship at the Mayo Clinic College of Medicine and Science, Rochester, Minn. He reports relationships with Exact Sciences, Pentax Medical, and others. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

Barrett’s esophagus (BE) is the only known precursor of esophageal adenocarcinoma (EAC). The rationale for early detection of BE rests on the premise that, after the diagnosis of BE, patients can be placed under endoscopic surveillance to detect prevalent and incident dysplasia and EAC. Randomized controlled trials have demonstrated that endoscopic eradication therapy (EET) of low-grade dysplasia (LGD) and high-grade dysplasia (HGD) can reduce progression to EAC. Guidelines support endoscopic screening for BE in those with multiple (three or more) risk factors.

However, endoscopy is expensive, invasive, and not widely utilized (less than 10% of those eligible are screened). Most patients with BE are unaware of their diagnosis and hence not under surveillance. Nonendoscopic techniques of BE detection – swallowed cell collection devices providing rich esophageal cytology specimens combined with biomarkers – are being developed. Case-control studies have shown promising accuracy and a recent UK pragmatic primary care study showed the ability of this technology to increase BE detection safely.

Detection of dysplasia in endoscopic surveillance is critical and the neoplasia detection rate (NDR) has been recently proposed as a quality marker. The NDR is the ratio of HGD+EAC detected to all patients with BE undergoing their first surveillance endoscopy. A recent systematic review and meta-analysis showed an inverse association between NDR and postendoscopy BE neoplasia. Additional and prospective studies are required to further correlate NDR values to clinically relevant outcomes similar to the association between adenoma detection rate and postcolonoscopy colorectal cancer.

Detection of dysplasia with endoscopic surveillance is challenging because of sampling error inherent in the Seattle protocol. A recent technology, Wide Area Transepithelial Sampling–3D (WATS), combines the concept of increased sampling of the BE mucosa by using a stiff endoscopic brush followed by use of artificial intelligence neural network enabled selection of abnormal cells, which are presented to a pathologist. This technology has been shown to increase dysplasia and HGD detection, compared to endoscopic surveillance, in a systematic review and meta-analysis. However, WATS is negative in a substantial proportion of cases in which endoscopic Seattle protocol reveals dysplasia. In addition, only limited data are available on the natural history of WATS LGD or HGD. Confirmation of WATS-only dysplasia (LGD, HGD, or EAC) by endoscopic histology is also recommended before the institution of EET. Finally, assessment of progression risk in those with BE is critical to enable more personalized follow up recommendations. Clinical risk scores integrating age, sex, smoking history, and LGD have been proposed and validated. A recent tissue systems pathology test has been shown in multiple case-control studies to identify a subset of BE patients who are at higher risk of progression, independent of LGD. This test is highly specific but only modestly sensitive in identifying progressors.

Dr. Iyer is professor of medicine, director of the Esophageal Interest Group, and codirector of the Advanced Esophageal Fellowship at the Mayo Clinic College of Medicine and Science, Rochester, Minn. He reports relationships with Exact Sciences, Pentax Medical, and others. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

Barrett’s esophagus (BE) is the only known precursor of esophageal adenocarcinoma (EAC). The rationale for early detection of BE rests on the premise that, after the diagnosis of BE, patients can be placed under endoscopic surveillance to detect prevalent and incident dysplasia and EAC. Randomized controlled trials have demonstrated that endoscopic eradication therapy (EET) of low-grade dysplasia (LGD) and high-grade dysplasia (HGD) can reduce progression to EAC. Guidelines support endoscopic screening for BE in those with multiple (three or more) risk factors.

However, endoscopy is expensive, invasive, and not widely utilized (less than 10% of those eligible are screened). Most patients with BE are unaware of their diagnosis and hence not under surveillance. Nonendoscopic techniques of BE detection – swallowed cell collection devices providing rich esophageal cytology specimens combined with biomarkers – are being developed. Case-control studies have shown promising accuracy and a recent UK pragmatic primary care study showed the ability of this technology to increase BE detection safely.

Detection of dysplasia in endoscopic surveillance is critical and the neoplasia detection rate (NDR) has been recently proposed as a quality marker. The NDR is the ratio of HGD+EAC detected to all patients with BE undergoing their first surveillance endoscopy. A recent systematic review and meta-analysis showed an inverse association between NDR and postendoscopy BE neoplasia. Additional and prospective studies are required to further correlate NDR values to clinically relevant outcomes similar to the association between adenoma detection rate and postcolonoscopy colorectal cancer.

Detection of dysplasia with endoscopic surveillance is challenging because of sampling error inherent in the Seattle protocol. A recent technology, Wide Area Transepithelial Sampling–3D (WATS), combines the concept of increased sampling of the BE mucosa by using a stiff endoscopic brush followed by use of artificial intelligence neural network enabled selection of abnormal cells, which are presented to a pathologist. This technology has been shown to increase dysplasia and HGD detection, compared to endoscopic surveillance, in a systematic review and meta-analysis. However, WATS is negative in a substantial proportion of cases in which endoscopic Seattle protocol reveals dysplasia. In addition, only limited data are available on the natural history of WATS LGD or HGD. Confirmation of WATS-only dysplasia (LGD, HGD, or EAC) by endoscopic histology is also recommended before the institution of EET. Finally, assessment of progression risk in those with BE is critical to enable more personalized follow up recommendations. Clinical risk scores integrating age, sex, smoking history, and LGD have been proposed and validated. A recent tissue systems pathology test has been shown in multiple case-control studies to identify a subset of BE patients who are at higher risk of progression, independent of LGD. This test is highly specific but only modestly sensitive in identifying progressors.

Dr. Iyer is professor of medicine, director of the Esophageal Interest Group, and codirector of the Advanced Esophageal Fellowship at the Mayo Clinic College of Medicine and Science, Rochester, Minn. He reports relationships with Exact Sciences, Pentax Medical, and others. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

Honor a family member, friend, or colleague while supporting the work of our mission through a gift to the AGA Research Foundation. Your gift will honor a loved one or yourself and support the AGA Research Awards Program, while giving you a tax benefit. The AGA Research Awards program recruits, retains, and supports the most promising investigators in gastroenterology and hepatology.

• Giving now or later. Any charitable gift can be made in honor or memory of someone.
• A gift today. An outright gift will help support researchers working toward developing new treatments and diagnostics for patients with GI conditions. Your gift will assist in fostering a new pipeline of scientists – the next generation of leaders in GI. The financial benefits include an income tax deduction and possible elimination of capital gains tax.
• A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly, a percentage of your estate will pass to the AGA Research Foundation at your death in honor of your loved one.

Conclusion

Your gift directly supports talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.






 

Honor a family member, friend, or colleague while supporting the work of our mission through a gift to the AGA Research Foundation. Your gift will honor a loved one or yourself and support the AGA Research Awards Program, while giving you a tax benefit. The AGA Research Awards program recruits, retains, and supports the most promising investigators in gastroenterology and hepatology.

• Giving now or later. Any charitable gift can be made in honor or memory of someone.
• A gift today. An outright gift will help support researchers working toward developing new treatments and diagnostics for patients with GI conditions. Your gift will assist in fostering a new pipeline of scientists – the next generation of leaders in GI. The financial benefits include an income tax deduction and possible elimination of capital gains tax.
• A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly, a percentage of your estate will pass to the AGA Research Foundation at your death in honor of your loved one.

Conclusion

Your gift directly supports talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.






 

Honor a family member, friend, or colleague while supporting the work of our mission through a gift to the AGA Research Foundation. Your gift will honor a loved one or yourself and support the AGA Research Awards Program, while giving you a tax benefit. The AGA Research Awards program recruits, retains, and supports the most promising investigators in gastroenterology and hepatology.

• Giving now or later. Any charitable gift can be made in honor or memory of someone.
• A gift today. An outright gift will help support researchers working toward developing new treatments and diagnostics for patients with GI conditions. Your gift will assist in fostering a new pipeline of scientists – the next generation of leaders in GI. The financial benefits include an income tax deduction and possible elimination of capital gains tax.
• A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly, a percentage of your estate will pass to the AGA Research Foundation at your death in honor of your loved one.

Conclusion

Your gift directly supports talented young researchers working to advance our understanding of digestive diseases. Make a tax-deductible donation to help spur innovation. Donate today at www.gastro.org/donateonline.






 

On July 15, the Centers for Medicare and Medicaid Services released the Medicare Hospital Outpatient Prospective Payment (OPP) and Ambulatory Surgical Center (ASC) Payment Systems Proposed Rule for calendar year 2023.

AGA, along with the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, have identified the following top three takeaways:

Slight increase in ASC payments – The proposed ASC conversion factor increases 2.7% to $51.315 for ASCs that meet quality reporting requirements.

Slight increase in facility fees payments – Hospitals that meet quality reporting requirements also receive a 2.7% proposed increase, which translates to $86.785 – a stark difference from the ASC payment.

18% cuts to some motility and G-tube codes – Hospital outpatient facility payments for motility codes 91117 and 91122 and G-tube codes 43761-43763 could decrease by 18% because of proposed changes to their Ambulatory Payment Classification (APC) family.

On July 15, the Centers for Medicare and Medicaid Services released the Medicare Hospital Outpatient Prospective Payment (OPP) and Ambulatory Surgical Center (ASC) Payment Systems Proposed Rule for calendar year 2023.

AGA, along with the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, have identified the following top three takeaways:

Slight increase in ASC payments – The proposed ASC conversion factor increases 2.7% to $51.315 for ASCs that meet quality reporting requirements.

Slight increase in facility fees payments – Hospitals that meet quality reporting requirements also receive a 2.7% proposed increase, which translates to $86.785 – a stark difference from the ASC payment.

18% cuts to some motility and G-tube codes – Hospital outpatient facility payments for motility codes 91117 and 91122 and G-tube codes 43761-43763 could decrease by 18% because of proposed changes to their Ambulatory Payment Classification (APC) family.

On July 15, the Centers for Medicare and Medicaid Services released the Medicare Hospital Outpatient Prospective Payment (OPP) and Ambulatory Surgical Center (ASC) Payment Systems Proposed Rule for calendar year 2023.

AGA, along with the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, have identified the following top three takeaways:

Slight increase in ASC payments – The proposed ASC conversion factor increases 2.7% to $51.315 for ASCs that meet quality reporting requirements.

Slight increase in facility fees payments – Hospitals that meet quality reporting requirements also receive a 2.7% proposed increase, which translates to $86.785 – a stark difference from the ASC payment.

18% cuts to some motility and G-tube codes – Hospital outpatient facility payments for motility codes 91117 and 91122 and G-tube codes 43761-43763 could decrease by 18% because of proposed changes to their Ambulatory Payment Classification (APC) family.

The U.S. Food and Drug Administration has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company that manufactures the drug has announced.

Until this approval, “there were no FDA-approved options to treat patients experiencing a GPP flare,” Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told this news organization. The approval “is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease,” he said. Treatment with spesolimab “rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares,” noted Dr. Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim, is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the United States.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Dr. Lebwohl is a paid consultant to Boehringer Ingelheim.

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

This article was updated 9/6/22.

The U.S. Food and Drug Administration has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company that manufactures the drug has announced.

Until this approval, “there were no FDA-approved options to treat patients experiencing a GPP flare,” Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told this news organization. The approval “is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease,” he said. Treatment with spesolimab “rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares,” noted Dr. Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim, is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the United States.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Dr. Lebwohl is a paid consultant to Boehringer Ingelheim.

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

This article was updated 9/6/22.

The U.S. Food and Drug Administration has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company that manufactures the drug has announced.

Until this approval, “there were no FDA-approved options to treat patients experiencing a GPP flare,” Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told this news organization. The approval “is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease,” he said. Treatment with spesolimab “rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares,” noted Dr. Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim, is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the United States.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Dr. Lebwohl is a paid consultant to Boehringer Ingelheim.

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

This article was updated 9/6/22.

Case

Ms. F. is a 68-year-old woman who presented to the hospital with sepsis, developed delirium, and stopped eating. Her clinicians recommended a PEG tube. Although she was inconsistently oriented to self, time, and place, she reiterated the same decision across multiple discussions: She did not want the PEG tube. Her replies to what would happen if she didn’t have the procedure and continued not to eat were consistent, too: “I’ll wither away.”

Ms. F. had impaired cognition. Do these impairments mean her clinicians should over-rule her choice? What evidence indicates whether she lacks decision-making capacity? This case of a patient refusing a potentially life-saving procedure amplifies the importance of asking these questions and integrating capacity assessments into clinical care. In this article, we will describe what capacity is, when and how to assess it, and the alternatives when a patient does not have capacity.
 

The ethical background

Before starting a medical treatment or procedure, a physician must obtain the patient’s informed consent. This is a core ethic of medicine. Informed consent describes the voluntary decision made by a competent patient following the disclosure of necessary information. Informed consent is key to achieving a balance between promoting patient self-determination and protecting vulnerable patients from harm. In most clinical encounters, informed consent unfolds effortlessly. However, in the care of patients who are acutely ill, particularly those in hospitals, fulfilling the ethic can be challenging.

It is important to have skills to recognize and address these challenges. One of the most common challenges to practicing the ethic of informed consent is the impact of illness on a person’s decision-making capacity. A patient who retains capacity ought to make his or her decisions and does not need someone else (a friend or a family member) to help with the decision.

Incapacity is unfortunately common among the acutely ill medical inpatient population, which typically skews older with more comorbidities.¹ Impairments frequently are overlooked for a variety of reasons,^2-6 including that many hospitalized patients do not challenge their doctors’ decisions. Doctors may be reluctant to assess capacity because the assessment may medically, legally, or ethically complicate the patient’s care.

Two common terms describe the outcome of an assessment of a patient’s decision-making abilities: competency and capacity. Competency describes a legal principle. It is granted or withdrawn by judicial review. The consequences of a judge rescinding competency are severe: A patient would need a guardian to make choices on his or her behalf.

Capacity, on the other hand, is a clinical concept. A physician assesses whether the patient can make a specific decision in a specific context. The difference between the two terms – competency and capacity – delineates what are the consequences of the assessment and which authority, a judge or a physician, has the right to withdraw a person’s decision-making authority.

The judge offers a global assessment that can lead to a guardianship. The physician’s decision is temporal and situational. Patients can lack capacity when they are ill and recover it when they are healed. Capacity is specific to each medical decision that the patient makes and so a person can lack capacity to make some decisions but not others.
 

Ethical framework to make assessment

Capacity is described by four decisional abilities: 1) communicate a choice, 2) understand relevant information, 3) appreciation, and 4) reasoning.⁷

Communication of a choice may be verbal or nonverbal, but the patient must be able to indicate the treatment choice clearly and consistently. Understanding describes knowing essential information a physician has conveyed. This is assessed by having the patients say back what they were told, such as: “Can you tell me in your own words what is a PEG tube?”

The components of appreciation are: the diagnosis or disorder and the benefits and risks of the proposed intervention as it relates to the diagnosis or disorder. Patients who appreciate their disorder have insight into their condition: “I’m not eating because I have an infection.” This can be assessed with a question such as: “Can you tell me in your own words what are the risks or downsides to you?” This prompt assesses the patient’s appreciation of risk. Reframing the question to ask, “Can you tell me about the upsides of this intervention?” will assess the patient’s appreciation of benefit.

Reasoning assesses the thought process and rationale for a person’s decision. It has two components – comparative and consequential reasoning. The first compares the different choices presented about the proposed intervention: “How does having a PEG tube compare to not having it?” The second asks about the consequences of each choice: “What might happen to a person who has the PEG tube?”

The capacity assessment evaluates a patient's performance on these decision-making abilities. This informs the clinician’s judgment of whether the patient has the capacity to make a decision. A patient who has capacity makes the choice, regardless of the physician’s preference or recommendation.

The physician’s duty is to decide which decision-making abilities to assess. Choice and understanding are essential. In riskier or more consequential decisions, a physician may raise the rigor of the assessment to include appreciation and reasoning.⁸ It is common practice for physicians to raise the standard for when to evaluate and how extensive their evaluation is when the decision is life-altering, as with a PEG tube versus a more routine, non–life-altering decision such as drawing blood for a routine wellness visit.

A simple scoring rubric determines the patient’s ability to answer each question along a range from adequate = 2, marginal = 1, to inadequate = 0. The extremes or adequate or inadequate are straightforward. Judgment is needed when performance is marginal. In the case of repeated marginal answers, a physician must strongly consider whether the patient lacks capacity to make the decision in question.⁹

Who receives a capacity assessment and when?

A good doctor is a good teacher. A doctor should therefore check that patients understand what is happening with their health. Assessing understanding is simply good medicine; for example, a good teacher ought to be asking an unimpaired patient without impaired cognition, “Can you say back to me the key points of what I explained?” With this approach, every patient is effectively “screened” for a capacity impairment.

Certain patients ought to trigger a more thorough examination of decisional abilities. Across multiple articles, the strongest factors associated with incapacity are older age and diminished cognitive function (often detected by MMSE scores below the low 20s).^1,7,10 Other factors that may amplify these deficits and thus should raise clinician concern would be patients with brain diseases such as Alzheimer’s or Parkinson’s, persons with lower education levels, or those who already have someone who helps them make decisions. To be sure, many older adults, even those with cognitive impairments, retain capacity, but extra protection should be in place to ensure their well-being.
 

Consequences of incapacity

If a careful assessment shows a patient has sound decision-making abilities, the patient is free to make the choice. On the other hand, a person does not have the capacity to make the decision at hand if he or she cannot communicate a choice or understand relevant information. Whether appreciation or reasoning ought to be assessed depends on the complexity and the significance of the decision. An assessment of decisional ability is not the end of the decision-making process. The goal is to maximize the patient’s autonomy.

Capacity can change over time. Factors that may inhibit capacity, such as medications, time of day, and even illness acuity, need to be accounted for and, if possible, addressed. The decision ought to be delayed, if possible, to a time when the patient has better chances of having capacity. If it is unlikely that patients’ status will change in the time frame needed to make the choice and they are found to not have capacity, then the decision making can be aided by advance directives or substitute decision makers such as family members or legal guardians.
 

Revisiting the case

Ms. F., who was delirious, retained notable decisional abilities. She understood the procedure of receiving the PEG tube and how the risk of continuing to not eat and not receive the PEG would result in dying by starvation. She appreciated her own diagnosis and how the proposed intervention could alter her condition. She appreciated how not having a PEG would lead to her death. Her choice to refuse the procedure was consistent. Ms. F. showed she retained capacity to make this decision. It was the physician’s duty to respect her autonomy and so to respect her refusal of the PEG.

Dr. Ney is a physician resident, department of psychiatry and human behavior, Thomas Jefferson University Hospital, Philadelphia. He has no conflicts to disclose. Dr. Karlawish is a professor in the departments of medicine, medical ethics and health policy, and neurology, University of Pennsylvania, Philadelphia. He is a site investigator for clinical trials sponsored by Biogen, Eisai, and Lilly.

References

1. Raymont V et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet. 2004;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

2. Hanson M and Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60(1):69-70. doi: 10.1503/cjs.004816.

3. Dahlberg J et al. Lack of informed consent for surgical procedures by elderly patients with inability to consent: A retrospective chart review from an academic medical center in Norway. Patient Saf Surg. 2019;13:24. doi: 10.1186/s13037-019-0205-5.

4. Sessums LL et al. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-7. doi: 10.1001/jama.2011.1023.

5. Terranova C et al. Ethical and medicolegal implications of capacity of patients in geriatric surgery. Med Sci Law. 2013;53(3):166-71. doi: 10.1177/0025802412473963.

6. John S et al. Assessing patients decision-making capacity in the hospital setting: A literature review. Aust J Rural Health. 2020;28(2):141-8. doi: 10.1111/ajr.12592.

7. Kim SYH et al. Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics. 2006;47(4):325-9. doi: 10.1176/appi.psy.47.4.325.

8. Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40. doi: 10.1056/NEJMcp074045.

9. Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91-8. doi: 10.1159/000109763.

10. Christensen K et al. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law. 1995;23(3):353-65.

Case

Ms. F. is a 68-year-old woman who presented to the hospital with sepsis, developed delirium, and stopped eating. Her clinicians recommended a PEG tube. Although she was inconsistently oriented to self, time, and place, she reiterated the same decision across multiple discussions: She did not want the PEG tube. Her replies to what would happen if she didn’t have the procedure and continued not to eat were consistent, too: “I’ll wither away.”

Ms. F. had impaired cognition. Do these impairments mean her clinicians should over-rule her choice? What evidence indicates whether she lacks decision-making capacity? This case of a patient refusing a potentially life-saving procedure amplifies the importance of asking these questions and integrating capacity assessments into clinical care. In this article, we will describe what capacity is, when and how to assess it, and the alternatives when a patient does not have capacity.
 

The ethical background

Before starting a medical treatment or procedure, a physician must obtain the patient’s informed consent. This is a core ethic of medicine. Informed consent describes the voluntary decision made by a competent patient following the disclosure of necessary information. Informed consent is key to achieving a balance between promoting patient self-determination and protecting vulnerable patients from harm. In most clinical encounters, informed consent unfolds effortlessly. However, in the care of patients who are acutely ill, particularly those in hospitals, fulfilling the ethic can be challenging.

It is important to have skills to recognize and address these challenges. One of the most common challenges to practicing the ethic of informed consent is the impact of illness on a person’s decision-making capacity. A patient who retains capacity ought to make his or her decisions and does not need someone else (a friend or a family member) to help with the decision.

Incapacity is unfortunately common among the acutely ill medical inpatient population, which typically skews older with more comorbidities.¹ Impairments frequently are overlooked for a variety of reasons,^2-6 including that many hospitalized patients do not challenge their doctors’ decisions. Doctors may be reluctant to assess capacity because the assessment may medically, legally, or ethically complicate the patient’s care.

Two common terms describe the outcome of an assessment of a patient’s decision-making abilities: competency and capacity. Competency describes a legal principle. It is granted or withdrawn by judicial review. The consequences of a judge rescinding competency are severe: A patient would need a guardian to make choices on his or her behalf.

Capacity, on the other hand, is a clinical concept. A physician assesses whether the patient can make a specific decision in a specific context. The difference between the two terms – competency and capacity – delineates what are the consequences of the assessment and which authority, a judge or a physician, has the right to withdraw a person’s decision-making authority.

The judge offers a global assessment that can lead to a guardianship. The physician’s decision is temporal and situational. Patients can lack capacity when they are ill and recover it when they are healed. Capacity is specific to each medical decision that the patient makes and so a person can lack capacity to make some decisions but not others.
 

Ethical framework to make assessment

Capacity is described by four decisional abilities: 1) communicate a choice, 2) understand relevant information, 3) appreciation, and 4) reasoning.⁷

Communication of a choice may be verbal or nonverbal, but the patient must be able to indicate the treatment choice clearly and consistently. Understanding describes knowing essential information a physician has conveyed. This is assessed by having the patients say back what they were told, such as: “Can you tell me in your own words what is a PEG tube?”

The components of appreciation are: the diagnosis or disorder and the benefits and risks of the proposed intervention as it relates to the diagnosis or disorder. Patients who appreciate their disorder have insight into their condition: “I’m not eating because I have an infection.” This can be assessed with a question such as: “Can you tell me in your own words what are the risks or downsides to you?” This prompt assesses the patient’s appreciation of risk. Reframing the question to ask, “Can you tell me about the upsides of this intervention?” will assess the patient’s appreciation of benefit.

Reasoning assesses the thought process and rationale for a person’s decision. It has two components – comparative and consequential reasoning. The first compares the different choices presented about the proposed intervention: “How does having a PEG tube compare to not having it?” The second asks about the consequences of each choice: “What might happen to a person who has the PEG tube?”

The capacity assessment evaluates a patient's performance on these decision-making abilities. This informs the clinician’s judgment of whether the patient has the capacity to make a decision. A patient who has capacity makes the choice, regardless of the physician’s preference or recommendation.

The physician’s duty is to decide which decision-making abilities to assess. Choice and understanding are essential. In riskier or more consequential decisions, a physician may raise the rigor of the assessment to include appreciation and reasoning.⁸ It is common practice for physicians to raise the standard for when to evaluate and how extensive their evaluation is when the decision is life-altering, as with a PEG tube versus a more routine, non–life-altering decision such as drawing blood for a routine wellness visit.

A simple scoring rubric determines the patient’s ability to answer each question along a range from adequate = 2, marginal = 1, to inadequate = 0. The extremes or adequate or inadequate are straightforward. Judgment is needed when performance is marginal. In the case of repeated marginal answers, a physician must strongly consider whether the patient lacks capacity to make the decision in question.⁹

Who receives a capacity assessment and when?

A good doctor is a good teacher. A doctor should therefore check that patients understand what is happening with their health. Assessing understanding is simply good medicine; for example, a good teacher ought to be asking an unimpaired patient without impaired cognition, “Can you say back to me the key points of what I explained?” With this approach, every patient is effectively “screened” for a capacity impairment.

Certain patients ought to trigger a more thorough examination of decisional abilities. Across multiple articles, the strongest factors associated with incapacity are older age and diminished cognitive function (often detected by MMSE scores below the low 20s).^1,7,10 Other factors that may amplify these deficits and thus should raise clinician concern would be patients with brain diseases such as Alzheimer’s or Parkinson’s, persons with lower education levels, or those who already have someone who helps them make decisions. To be sure, many older adults, even those with cognitive impairments, retain capacity, but extra protection should be in place to ensure their well-being.
 

Consequences of incapacity

If a careful assessment shows a patient has sound decision-making abilities, the patient is free to make the choice. On the other hand, a person does not have the capacity to make the decision at hand if he or she cannot communicate a choice or understand relevant information. Whether appreciation or reasoning ought to be assessed depends on the complexity and the significance of the decision. An assessment of decisional ability is not the end of the decision-making process. The goal is to maximize the patient’s autonomy.

Capacity can change over time. Factors that may inhibit capacity, such as medications, time of day, and even illness acuity, need to be accounted for and, if possible, addressed. The decision ought to be delayed, if possible, to a time when the patient has better chances of having capacity. If it is unlikely that patients’ status will change in the time frame needed to make the choice and they are found to not have capacity, then the decision making can be aided by advance directives or substitute decision makers such as family members or legal guardians.
 

Revisiting the case

Ms. F., who was delirious, retained notable decisional abilities. She understood the procedure of receiving the PEG tube and how the risk of continuing to not eat and not receive the PEG would result in dying by starvation. She appreciated her own diagnosis and how the proposed intervention could alter her condition. She appreciated how not having a PEG would lead to her death. Her choice to refuse the procedure was consistent. Ms. F. showed she retained capacity to make this decision. It was the physician’s duty to respect her autonomy and so to respect her refusal of the PEG.

Dr. Ney is a physician resident, department of psychiatry and human behavior, Thomas Jefferson University Hospital, Philadelphia. He has no conflicts to disclose. Dr. Karlawish is a professor in the departments of medicine, medical ethics and health policy, and neurology, University of Pennsylvania, Philadelphia. He is a site investigator for clinical trials sponsored by Biogen, Eisai, and Lilly.

References

1. Raymont V et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet. 2004;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

2. Hanson M and Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60(1):69-70. doi: 10.1503/cjs.004816.

3. Dahlberg J et al. Lack of informed consent for surgical procedures by elderly patients with inability to consent: A retrospective chart review from an academic medical center in Norway. Patient Saf Surg. 2019;13:24. doi: 10.1186/s13037-019-0205-5.

4. Sessums LL et al. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-7. doi: 10.1001/jama.2011.1023.

5. Terranova C et al. Ethical and medicolegal implications of capacity of patients in geriatric surgery. Med Sci Law. 2013;53(3):166-71. doi: 10.1177/0025802412473963.

6. John S et al. Assessing patients decision-making capacity in the hospital setting: A literature review. Aust J Rural Health. 2020;28(2):141-8. doi: 10.1111/ajr.12592.

7. Kim SYH et al. Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics. 2006;47(4):325-9. doi: 10.1176/appi.psy.47.4.325.

8. Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40. doi: 10.1056/NEJMcp074045.

9. Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91-8. doi: 10.1159/000109763.

10. Christensen K et al. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law. 1995;23(3):353-65.

Case

Ms. F. is a 68-year-old woman who presented to the hospital with sepsis, developed delirium, and stopped eating. Her clinicians recommended a PEG tube. Although she was inconsistently oriented to self, time, and place, she reiterated the same decision across multiple discussions: She did not want the PEG tube. Her replies to what would happen if she didn’t have the procedure and continued not to eat were consistent, too: “I’ll wither away.”

Ms. F. had impaired cognition. Do these impairments mean her clinicians should over-rule her choice? What evidence indicates whether she lacks decision-making capacity? This case of a patient refusing a potentially life-saving procedure amplifies the importance of asking these questions and integrating capacity assessments into clinical care. In this article, we will describe what capacity is, when and how to assess it, and the alternatives when a patient does not have capacity.
 

The ethical background

Before starting a medical treatment or procedure, a physician must obtain the patient’s informed consent. This is a core ethic of medicine. Informed consent describes the voluntary decision made by a competent patient following the disclosure of necessary information. Informed consent is key to achieving a balance between promoting patient self-determination and protecting vulnerable patients from harm. In most clinical encounters, informed consent unfolds effortlessly. However, in the care of patients who are acutely ill, particularly those in hospitals, fulfilling the ethic can be challenging.

It is important to have skills to recognize and address these challenges. One of the most common challenges to practicing the ethic of informed consent is the impact of illness on a person’s decision-making capacity. A patient who retains capacity ought to make his or her decisions and does not need someone else (a friend or a family member) to help with the decision.

Incapacity is unfortunately common among the acutely ill medical inpatient population, which typically skews older with more comorbidities.¹ Impairments frequently are overlooked for a variety of reasons,^2-6 including that many hospitalized patients do not challenge their doctors’ decisions. Doctors may be reluctant to assess capacity because the assessment may medically, legally, or ethically complicate the patient’s care.

Two common terms describe the outcome of an assessment of a patient’s decision-making abilities: competency and capacity. Competency describes a legal principle. It is granted or withdrawn by judicial review. The consequences of a judge rescinding competency are severe: A patient would need a guardian to make choices on his or her behalf.

Capacity, on the other hand, is a clinical concept. A physician assesses whether the patient can make a specific decision in a specific context. The difference between the two terms – competency and capacity – delineates what are the consequences of the assessment and which authority, a judge or a physician, has the right to withdraw a person’s decision-making authority.

The judge offers a global assessment that can lead to a guardianship. The physician’s decision is temporal and situational. Patients can lack capacity when they are ill and recover it when they are healed. Capacity is specific to each medical decision that the patient makes and so a person can lack capacity to make some decisions but not others.
 

Ethical framework to make assessment

Capacity is described by four decisional abilities: 1) communicate a choice, 2) understand relevant information, 3) appreciation, and 4) reasoning.⁷

Communication of a choice may be verbal or nonverbal, but the patient must be able to indicate the treatment choice clearly and consistently. Understanding describes knowing essential information a physician has conveyed. This is assessed by having the patients say back what they were told, such as: “Can you tell me in your own words what is a PEG tube?”

The components of appreciation are: the diagnosis or disorder and the benefits and risks of the proposed intervention as it relates to the diagnosis or disorder. Patients who appreciate their disorder have insight into their condition: “I’m not eating because I have an infection.” This can be assessed with a question such as: “Can you tell me in your own words what are the risks or downsides to you?” This prompt assesses the patient’s appreciation of risk. Reframing the question to ask, “Can you tell me about the upsides of this intervention?” will assess the patient’s appreciation of benefit.

Reasoning assesses the thought process and rationale for a person’s decision. It has two components – comparative and consequential reasoning. The first compares the different choices presented about the proposed intervention: “How does having a PEG tube compare to not having it?” The second asks about the consequences of each choice: “What might happen to a person who has the PEG tube?”

The capacity assessment evaluates a patient's performance on these decision-making abilities. This informs the clinician’s judgment of whether the patient has the capacity to make a decision. A patient who has capacity makes the choice, regardless of the physician’s preference or recommendation.

The physician’s duty is to decide which decision-making abilities to assess. Choice and understanding are essential. In riskier or more consequential decisions, a physician may raise the rigor of the assessment to include appreciation and reasoning.⁸ It is common practice for physicians to raise the standard for when to evaluate and how extensive their evaluation is when the decision is life-altering, as with a PEG tube versus a more routine, non–life-altering decision such as drawing blood for a routine wellness visit.

A simple scoring rubric determines the patient’s ability to answer each question along a range from adequate = 2, marginal = 1, to inadequate = 0. The extremes or adequate or inadequate are straightforward. Judgment is needed when performance is marginal. In the case of repeated marginal answers, a physician must strongly consider whether the patient lacks capacity to make the decision in question.⁹

Who receives a capacity assessment and when?

A good doctor is a good teacher. A doctor should therefore check that patients understand what is happening with their health. Assessing understanding is simply good medicine; for example, a good teacher ought to be asking an unimpaired patient without impaired cognition, “Can you say back to me the key points of what I explained?” With this approach, every patient is effectively “screened” for a capacity impairment.

Certain patients ought to trigger a more thorough examination of decisional abilities. Across multiple articles, the strongest factors associated with incapacity are older age and diminished cognitive function (often detected by MMSE scores below the low 20s).^1,7,10 Other factors that may amplify these deficits and thus should raise clinician concern would be patients with brain diseases such as Alzheimer’s or Parkinson’s, persons with lower education levels, or those who already have someone who helps them make decisions. To be sure, many older adults, even those with cognitive impairments, retain capacity, but extra protection should be in place to ensure their well-being.
 

Consequences of incapacity

If a careful assessment shows a patient has sound decision-making abilities, the patient is free to make the choice. On the other hand, a person does not have the capacity to make the decision at hand if he or she cannot communicate a choice or understand relevant information. Whether appreciation or reasoning ought to be assessed depends on the complexity and the significance of the decision. An assessment of decisional ability is not the end of the decision-making process. The goal is to maximize the patient’s autonomy.

Capacity can change over time. Factors that may inhibit capacity, such as medications, time of day, and even illness acuity, need to be accounted for and, if possible, addressed. The decision ought to be delayed, if possible, to a time when the patient has better chances of having capacity. If it is unlikely that patients’ status will change in the time frame needed to make the choice and they are found to not have capacity, then the decision making can be aided by advance directives or substitute decision makers such as family members or legal guardians.
 

Revisiting the case

Ms. F., who was delirious, retained notable decisional abilities. She understood the procedure of receiving the PEG tube and how the risk of continuing to not eat and not receive the PEG would result in dying by starvation. She appreciated her own diagnosis and how the proposed intervention could alter her condition. She appreciated how not having a PEG would lead to her death. Her choice to refuse the procedure was consistent. Ms. F. showed she retained capacity to make this decision. It was the physician’s duty to respect her autonomy and so to respect her refusal of the PEG.

Dr. Ney is a physician resident, department of psychiatry and human behavior, Thomas Jefferson University Hospital, Philadelphia. He has no conflicts to disclose. Dr. Karlawish is a professor in the departments of medicine, medical ethics and health policy, and neurology, University of Pennsylvania, Philadelphia. He is a site investigator for clinical trials sponsored by Biogen, Eisai, and Lilly.

References

1. Raymont V et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet. 2004;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

2. Hanson M and Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60(1):69-70. doi: 10.1503/cjs.004816.

3. Dahlberg J et al. Lack of informed consent for surgical procedures by elderly patients with inability to consent: A retrospective chart review from an academic medical center in Norway. Patient Saf Surg. 2019;13:24. doi: 10.1186/s13037-019-0205-5.

4. Sessums LL et al. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-7. doi: 10.1001/jama.2011.1023.

5. Terranova C et al. Ethical and medicolegal implications of capacity of patients in geriatric surgery. Med Sci Law. 2013;53(3):166-71. doi: 10.1177/0025802412473963.

6. John S et al. Assessing patients decision-making capacity in the hospital setting: A literature review. Aust J Rural Health. 2020;28(2):141-8. doi: 10.1111/ajr.12592.

7. Kim SYH et al. Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics. 2006;47(4):325-9. doi: 10.1176/appi.psy.47.4.325.

8. Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40. doi: 10.1056/NEJMcp074045.

9. Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91-8. doi: 10.1159/000109763.

10. Christensen K et al. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law. 1995;23(3):353-65.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

After malaria, human schistosomiasis is the parasitic disease with the highest morbidity and mortality worldwide. An estimated 236 million people are infected. Most are in sub-Saharan Africa. Complications lead to the deaths of 300,000 people each year. Pilot studies point to a high rate of underdiagnosis, whether in the sub-Saharan immigrant population residing in Spain or among individuals affected by outbreaks of autochthonous transmission (as happened in the 2003 case of four Spanish farmers who bathed in an artificial irrigation pool in Almería). If not diagnosed and treated in a timely manner, schistosomiasis can cause serious genitourinary and hepatosplenic complications.

The “Consensus Document for the Management of Schistosomiasis in Primary Care” was recently published in the journal Atención Primaria [Primary Care]. Its aim is to establish clear recommendations so that primary care clinicians will be able to diagnose, manage, and treat this disease. The document was prepared by professionals who belong to the following five scientific societies: the Spanish Society of Family and Community Medicine, the Spanish Society of General Practitioners and Family Doctors, the Spanish Society of Primary Care Physicians, the Spanish Society for Pediatric Infectious Diseases, and the Spanish Society of Tropical Medicine and International Health (SEMTSI).

Agustín Benito Llanes, PhD, is the director of Spain’s National Center for Tropical Medicine (Carlos III Institute of Health) and the president of the SEMTSI. He told Univadis Spain, “The consensus document is invaluable for the management of cases imported by migrant populations coming from endemic areas and in the prevention of possible outbreaks in our country, especially urinary schistosomiasis.” He went on to explain, “This diagnostic strategy, which is also recommended by the European Centre for Disease Prevention and Control (ECDC), must be viewed in the context of the general management of patients with imported eosinophilia – eosinophilia being a condition that indicates that the individual may have a disease caused by a parasitic worm. I do know that primary care has been greatly affected and impacted by the pandemic, but new e-consultation and telemedicine models are making it possible for hospital specialists and primary care specialists to quickly get in touch with each other and work closely together. This technology can play a critical role in the shared care of patients with these types of diseases.”

The document recommends that serologic screening for schistosomiasis be considered for the following patients: asymptomatic individuals who have come from endemic regions and were exposed to freshwater sources; those who present with symptoms consistent with those of the disease; and patients for whom clinical exams or lab tests suggest acute schistosomiasis (eosinophilia is usually a sign). Screening for chronic schistosomiasis is indicated if the necessary resources for diagnosis and treatment are not available. The following considerations support screening asymptomatic individuals: the high prevalence of parasitic infection among migrants from endemic regions and among people who have traveled to those places; and the possibility of preventing serious complications and secondary transmissions.

The working group recommends that all at-risk individuals undergo screening, no matter how long it’s been since they were last in an endemic zone. This is because the parasites can live for over a decade. If primary care physicians don’t have access to diagnostic tests or to treatments, patients should be referred to specialists with experience in tropical diseases. A definitive diagnosis is made through the detection of blood fluke eggs in urine, stool, or body tissues. Through such detection, the species responsible for infection can be identified.
 

Primary care difficulties

To prevent and control the disease, the European health authorities recommend serologic screening of at-risk population groups. Because primary care is usually the first point of contact with the health care system for these infected patients, primary care physicians must know the main characteristics of schistosomiasis and be provided with the necessary means for its diagnosis and treatment. Yet physicians in health care centers face significant limitations when it comes to identifying and treating these patients.

Joaquín Salas, MD, director of the Tropical Medicine Unit at Poniente Hospital in El Ejido (Almería) and the document’s first author, explained these difficulties. “In Spain, we currently have the problem where the care of migrant patients varies greatly between the different autonomous communities – and even within an autonomous community, depending on geographical areas. This variability is caused, in large part, by the number of migrants that they serve. In places that have a large sub-Saharan migrant population, there are health centers that have gotten to a point where they’re able to request serologic testing for schistosomiasis. Unfortunately, in many instances, this testing is still only available to specialists. The objective of documents like ours is to make not only physicians but also managers aware of the importance of diagnosing and treating this disease as early as possible. Raising awareness is complicated, to a large extent, by the lack of knowledge about this disease – something that’s seen with many other ‘neglected diseases’ which primarily affect the poorest people in poor countries.”

Dr. Llanes explained that an autonomous community can individually approve serologic screenings and incorporate them into its primary care programs, regardless of whether they can be approved at the state level. He pointed out that this is what happened with Chagas disease. “To prevent vertical transmission, a protocol for pregnant women was implemented by several communities; it’s about to be approved on a national level.”

But there’s another obstacle to treating schistosomiasis. At the moment, the recommended antiparasitic treatments (e.g., praziquantel) are considered foreign medications. This makes it difficult for primary care physicians and specialists to have access to them. Even so, Dr. Salas believes “that in some places, pharmacy units facilitate things in such a way that physicians who prescribe those treatments are able to obtain them quite quickly and with less red tape. Be that as it may, ideally, the medication would be available in our country’s pharmacies, and it could be prescribed without these kinds of bureaucratic obstacles. The same thing happened with ivermectin, which is used, among other things, to treat strongyloidiasis, and which, for a few months now, has been on the market without restrictions. We hope the same will happen soon with praziquantel.”
 

Increasing risk

Although schistosomiasis is not endemic to Spain, various factors are contributing to an increase in the number of cases within its borders. Dr. Salas said that “without a doubt, climate change and global warming are influencing the expansion of vectors – mosquitoes, ticks, snails – that can transmit, to places like Europe, diseases referred to as ‘tropical.’ In the case of schistosomiasis, it’s been shown that Bulinus snails, intermediate hosts for Schistosoma, have adapted perfectly to Almería here in Spain and to the French island of Corsica, where winters are more and more temperate. But not only is this adaptation due to climate change, those same snails have acquired specific capabilities that allow them to better tolerate temperatures lower than those they initially had in the areas where they’re from in sub-Saharan Africa. To sum up, the colonization of new territories is due as much to a change in the climate – temperatures gradually rising – as to adaptations of the vectors themselves.”

Dr. Llanes noted that “the case involving the farmers in Almería shows that the vectors in Europe can, in fact, transmit the disease, basically because Schistosoma haematobium, human, can develop hybrids with schistosomes of cattle origin, Schistosoma bovis – hybrids that can be transmitted through European snails. This is what happened with the outbreak in Corsica, its vector being the freshwater snail Planorbarius metidjensis – as I said, shown to be implicated in Corsica’s significant outbreak, to which subsequent cases are still being traced. Obviously, the effects of climate change – temperatures rising and extreme meteorological phenomena increasing – on the infections transmitted by vectors are of the utmost importance and, together with the process of globalization, are what makes us consider these types of conditions to be emerging diseases or emerging infections.”

This article was translated from Univadis Spain. A version appeared on Medscape.com.

After malaria, human schistosomiasis is the parasitic disease with the highest morbidity and mortality worldwide. An estimated 236 million people are infected. Most are in sub-Saharan Africa. Complications lead to the deaths of 300,000 people each year. Pilot studies point to a high rate of underdiagnosis, whether in the sub-Saharan immigrant population residing in Spain or among individuals affected by outbreaks of autochthonous transmission (as happened in the 2003 case of four Spanish farmers who bathed in an artificial irrigation pool in Almería). If not diagnosed and treated in a timely manner, schistosomiasis can cause serious genitourinary and hepatosplenic complications.

The “Consensus Document for the Management of Schistosomiasis in Primary Care” was recently published in the journal Atención Primaria [Primary Care]. Its aim is to establish clear recommendations so that primary care clinicians will be able to diagnose, manage, and treat this disease. The document was prepared by professionals who belong to the following five scientific societies: the Spanish Society of Family and Community Medicine, the Spanish Society of General Practitioners and Family Doctors, the Spanish Society of Primary Care Physicians, the Spanish Society for Pediatric Infectious Diseases, and the Spanish Society of Tropical Medicine and International Health (SEMTSI).

Agustín Benito Llanes, PhD, is the director of Spain’s National Center for Tropical Medicine (Carlos III Institute of Health) and the president of the SEMTSI. He told Univadis Spain, “The consensus document is invaluable for the management of cases imported by migrant populations coming from endemic areas and in the prevention of possible outbreaks in our country, especially urinary schistosomiasis.” He went on to explain, “This diagnostic strategy, which is also recommended by the European Centre for Disease Prevention and Control (ECDC), must be viewed in the context of the general management of patients with imported eosinophilia – eosinophilia being a condition that indicates that the individual may have a disease caused by a parasitic worm. I do know that primary care has been greatly affected and impacted by the pandemic, but new e-consultation and telemedicine models are making it possible for hospital specialists and primary care specialists to quickly get in touch with each other and work closely together. This technology can play a critical role in the shared care of patients with these types of diseases.”

The document recommends that serologic screening for schistosomiasis be considered for the following patients: asymptomatic individuals who have come from endemic regions and were exposed to freshwater sources; those who present with symptoms consistent with those of the disease; and patients for whom clinical exams or lab tests suggest acute schistosomiasis (eosinophilia is usually a sign). Screening for chronic schistosomiasis is indicated if the necessary resources for diagnosis and treatment are not available. The following considerations support screening asymptomatic individuals: the high prevalence of parasitic infection among migrants from endemic regions and among people who have traveled to those places; and the possibility of preventing serious complications and secondary transmissions.

The working group recommends that all at-risk individuals undergo screening, no matter how long it’s been since they were last in an endemic zone. This is because the parasites can live for over a decade. If primary care physicians don’t have access to diagnostic tests or to treatments, patients should be referred to specialists with experience in tropical diseases. A definitive diagnosis is made through the detection of blood fluke eggs in urine, stool, or body tissues. Through such detection, the species responsible for infection can be identified.
 

Primary care difficulties

To prevent and control the disease, the European health authorities recommend serologic screening of at-risk population groups. Because primary care is usually the first point of contact with the health care system for these infected patients, primary care physicians must know the main characteristics of schistosomiasis and be provided with the necessary means for its diagnosis and treatment. Yet physicians in health care centers face significant limitations when it comes to identifying and treating these patients.

Joaquín Salas, MD, director of the Tropical Medicine Unit at Poniente Hospital in El Ejido (Almería) and the document’s first author, explained these difficulties. “In Spain, we currently have the problem where the care of migrant patients varies greatly between the different autonomous communities – and even within an autonomous community, depending on geographical areas. This variability is caused, in large part, by the number of migrants that they serve. In places that have a large sub-Saharan migrant population, there are health centers that have gotten to a point where they’re able to request serologic testing for schistosomiasis. Unfortunately, in many instances, this testing is still only available to specialists. The objective of documents like ours is to make not only physicians but also managers aware of the importance of diagnosing and treating this disease as early as possible. Raising awareness is complicated, to a large extent, by the lack of knowledge about this disease – something that’s seen with many other ‘neglected diseases’ which primarily affect the poorest people in poor countries.”

Dr. Llanes explained that an autonomous community can individually approve serologic screenings and incorporate them into its primary care programs, regardless of whether they can be approved at the state level. He pointed out that this is what happened with Chagas disease. “To prevent vertical transmission, a protocol for pregnant women was implemented by several communities; it’s about to be approved on a national level.”

But there’s another obstacle to treating schistosomiasis. At the moment, the recommended antiparasitic treatments (e.g., praziquantel) are considered foreign medications. This makes it difficult for primary care physicians and specialists to have access to them. Even so, Dr. Salas believes “that in some places, pharmacy units facilitate things in such a way that physicians who prescribe those treatments are able to obtain them quite quickly and with less red tape. Be that as it may, ideally, the medication would be available in our country’s pharmacies, and it could be prescribed without these kinds of bureaucratic obstacles. The same thing happened with ivermectin, which is used, among other things, to treat strongyloidiasis, and which, for a few months now, has been on the market without restrictions. We hope the same will happen soon with praziquantel.”
 

Increasing risk

Although schistosomiasis is not endemic to Spain, various factors are contributing to an increase in the number of cases within its borders. Dr. Salas said that “without a doubt, climate change and global warming are influencing the expansion of vectors – mosquitoes, ticks, snails – that can transmit, to places like Europe, diseases referred to as ‘tropical.’ In the case of schistosomiasis, it’s been shown that Bulinus snails, intermediate hosts for Schistosoma, have adapted perfectly to Almería here in Spain and to the French island of Corsica, where winters are more and more temperate. But not only is this adaptation due to climate change, those same snails have acquired specific capabilities that allow them to better tolerate temperatures lower than those they initially had in the areas where they’re from in sub-Saharan Africa. To sum up, the colonization of new territories is due as much to a change in the climate – temperatures gradually rising – as to adaptations of the vectors themselves.”

Dr. Llanes noted that “the case involving the farmers in Almería shows that the vectors in Europe can, in fact, transmit the disease, basically because Schistosoma haematobium, human, can develop hybrids with schistosomes of cattle origin, Schistosoma bovis – hybrids that can be transmitted through European snails. This is what happened with the outbreak in Corsica, its vector being the freshwater snail Planorbarius metidjensis – as I said, shown to be implicated in Corsica’s significant outbreak, to which subsequent cases are still being traced. Obviously, the effects of climate change – temperatures rising and extreme meteorological phenomena increasing – on the infections transmitted by vectors are of the utmost importance and, together with the process of globalization, are what makes us consider these types of conditions to be emerging diseases or emerging infections.”

This article was translated from Univadis Spain. A version appeared on Medscape.com.

After malaria, human schistosomiasis is the parasitic disease with the highest morbidity and mortality worldwide. An estimated 236 million people are infected. Most are in sub-Saharan Africa. Complications lead to the deaths of 300,000 people each year. Pilot studies point to a high rate of underdiagnosis, whether in the sub-Saharan immigrant population residing in Spain or among individuals affected by outbreaks of autochthonous transmission (as happened in the 2003 case of four Spanish farmers who bathed in an artificial irrigation pool in Almería). If not diagnosed and treated in a timely manner, schistosomiasis can cause serious genitourinary and hepatosplenic complications.

The “Consensus Document for the Management of Schistosomiasis in Primary Care” was recently published in the journal Atención Primaria [Primary Care]. Its aim is to establish clear recommendations so that primary care clinicians will be able to diagnose, manage, and treat this disease. The document was prepared by professionals who belong to the following five scientific societies: the Spanish Society of Family and Community Medicine, the Spanish Society of General Practitioners and Family Doctors, the Spanish Society of Primary Care Physicians, the Spanish Society for Pediatric Infectious Diseases, and the Spanish Society of Tropical Medicine and International Health (SEMTSI).

Agustín Benito Llanes, PhD, is the director of Spain’s National Center for Tropical Medicine (Carlos III Institute of Health) and the president of the SEMTSI. He told Univadis Spain, “The consensus document is invaluable for the management of cases imported by migrant populations coming from endemic areas and in the prevention of possible outbreaks in our country, especially urinary schistosomiasis.” He went on to explain, “This diagnostic strategy, which is also recommended by the European Centre for Disease Prevention and Control (ECDC), must be viewed in the context of the general management of patients with imported eosinophilia – eosinophilia being a condition that indicates that the individual may have a disease caused by a parasitic worm. I do know that primary care has been greatly affected and impacted by the pandemic, but new e-consultation and telemedicine models are making it possible for hospital specialists and primary care specialists to quickly get in touch with each other and work closely together. This technology can play a critical role in the shared care of patients with these types of diseases.”

The document recommends that serologic screening for schistosomiasis be considered for the following patients: asymptomatic individuals who have come from endemic regions and were exposed to freshwater sources; those who present with symptoms consistent with those of the disease; and patients for whom clinical exams or lab tests suggest acute schistosomiasis (eosinophilia is usually a sign). Screening for chronic schistosomiasis is indicated if the necessary resources for diagnosis and treatment are not available. The following considerations support screening asymptomatic individuals: the high prevalence of parasitic infection among migrants from endemic regions and among people who have traveled to those places; and the possibility of preventing serious complications and secondary transmissions.

The working group recommends that all at-risk individuals undergo screening, no matter how long it’s been since they were last in an endemic zone. This is because the parasites can live for over a decade. If primary care physicians don’t have access to diagnostic tests or to treatments, patients should be referred to specialists with experience in tropical diseases. A definitive diagnosis is made through the detection of blood fluke eggs in urine, stool, or body tissues. Through such detection, the species responsible for infection can be identified.
 

Primary care difficulties

To prevent and control the disease, the European health authorities recommend serologic screening of at-risk population groups. Because primary care is usually the first point of contact with the health care system for these infected patients, primary care physicians must know the main characteristics of schistosomiasis and be provided with the necessary means for its diagnosis and treatment. Yet physicians in health care centers face significant limitations when it comes to identifying and treating these patients.

Joaquín Salas, MD, director of the Tropical Medicine Unit at Poniente Hospital in El Ejido (Almería) and the document’s first author, explained these difficulties. “In Spain, we currently have the problem where the care of migrant patients varies greatly between the different autonomous communities – and even within an autonomous community, depending on geographical areas. This variability is caused, in large part, by the number of migrants that they serve. In places that have a large sub-Saharan migrant population, there are health centers that have gotten to a point where they’re able to request serologic testing for schistosomiasis. Unfortunately, in many instances, this testing is still only available to specialists. The objective of documents like ours is to make not only physicians but also managers aware of the importance of diagnosing and treating this disease as early as possible. Raising awareness is complicated, to a large extent, by the lack of knowledge about this disease – something that’s seen with many other ‘neglected diseases’ which primarily affect the poorest people in poor countries.”

Dr. Llanes explained that an autonomous community can individually approve serologic screenings and incorporate them into its primary care programs, regardless of whether they can be approved at the state level. He pointed out that this is what happened with Chagas disease. “To prevent vertical transmission, a protocol for pregnant women was implemented by several communities; it’s about to be approved on a national level.”

But there’s another obstacle to treating schistosomiasis. At the moment, the recommended antiparasitic treatments (e.g., praziquantel) are considered foreign medications. This makes it difficult for primary care physicians and specialists to have access to them. Even so, Dr. Salas believes “that in some places, pharmacy units facilitate things in such a way that physicians who prescribe those treatments are able to obtain them quite quickly and with less red tape. Be that as it may, ideally, the medication would be available in our country’s pharmacies, and it could be prescribed without these kinds of bureaucratic obstacles. The same thing happened with ivermectin, which is used, among other things, to treat strongyloidiasis, and which, for a few months now, has been on the market without restrictions. We hope the same will happen soon with praziquantel.”
 

Increasing risk

Although schistosomiasis is not endemic to Spain, various factors are contributing to an increase in the number of cases within its borders. Dr. Salas said that “without a doubt, climate change and global warming are influencing the expansion of vectors – mosquitoes, ticks, snails – that can transmit, to places like Europe, diseases referred to as ‘tropical.’ In the case of schistosomiasis, it’s been shown that Bulinus snails, intermediate hosts for Schistosoma, have adapted perfectly to Almería here in Spain and to the French island of Corsica, where winters are more and more temperate. But not only is this adaptation due to climate change, those same snails have acquired specific capabilities that allow them to better tolerate temperatures lower than those they initially had in the areas where they’re from in sub-Saharan Africa. To sum up, the colonization of new territories is due as much to a change in the climate – temperatures gradually rising – as to adaptations of the vectors themselves.”

Dr. Llanes noted that “the case involving the farmers in Almería shows that the vectors in Europe can, in fact, transmit the disease, basically because Schistosoma haematobium, human, can develop hybrids with schistosomes of cattle origin, Schistosoma bovis – hybrids that can be transmitted through European snails. This is what happened with the outbreak in Corsica, its vector being the freshwater snail Planorbarius metidjensis – as I said, shown to be implicated in Corsica’s significant outbreak, to which subsequent cases are still being traced. Obviously, the effects of climate change – temperatures rising and extreme meteorological phenomena increasing – on the infections transmitted by vectors are of the utmost importance and, together with the process of globalization, are what makes us consider these types of conditions to be emerging diseases or emerging infections.”

This article was translated from Univadis Spain. A version appeared on Medscape.com.