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An appeal for equitable access to care for early pregnancy loss
Remarkable advances in care for early pregnancy loss (EPL) have occurred over the past several years. Misoprostol with mifepristone pretreatment is now the gold standard for medical management after recent research showed that this regimen improves both the efficacy and cost-effectiveness of medical management.1 Manual vacuum aspiration (MVA)’s portability, effectiveness, and safety ensure that providers can offer procedural EPL management in almost any clinical setting. Medication management and in-office uterine aspiration are two evidence-based options for EPL management that may increase access for the 25% of pregnant women who experience EPL. Unfortunately, many women do not have access to either option. Equitable access to early pregnancy loss management can be achieved by expanding access to mifepristone and office-based MVA.
However, access to mifepristone and initiating office-based MVA is challenging. Mifepristone is one of several medications regulated under the Food and Drug Administration’s Risk Evaluation and Management Strategies (REMS) program.2
The REMS guidelines restrict clinicians in prescribing and dispensing mifepristone, including the key provision that mifepristone may be dispensed only in clinics, medical offices, and hospitals. Clinicians cannot write a prescription for mifepristone for a patient to pick up at the pharmacy. Efforts are underway to roll back the REMS. Barriers to office-based MVA include time, culture shift among staff, gathering equipment, and creating protocols. Clinicians can improve access to EPL management in a variety of ways:
- MVA training: Ob.gyns. who lack training in MVA use can take advantage of several programs designed to teach the skill to clinicians, including programs such as Training, Education, and Advocacy in Miscarriage Management (TEAMM).3,4 MVA is easy to learn for ob.gyns. and procedural complications are uncommon. In the office setting, complications requiring transfer to a higher level of care are rare.5 With adequate training, whether during residency or afterward, ob.gyns. can learn to safely and effectively use MVA for procedural EPL management in the office and in the emergency department.
- Partnerships with pharmacists to reduce barriers to mifepristone: Ob.gyns. working in a variety of clinical settings, including independent clinics, critical access hospitals, community hospitals, and academic medical centers, have worked closely with on-site pharmacists to place mifepristone on their practice sites’ formularies.6 These ob.gyn.–pharmacist collaborations often require explanations to institutional Pharmacy and Therapeutics (P&T) committees of the benefits of mifepristone to patients, detailed indications for mifepristone’s use, and methods to secure mifepristone on site.
- Partnerships with emergency department and outpatient nursing and administration to promote MVA: Provision of MVA is ideal for safe, effective, and cost-efficient procedural EPL management in both the emergency department and outpatient setting. However, access to MVA in emergency rooms and outpatient clinical settings is suboptimal. Some clinicians push back against MVA use in the emergency department, citing fears that performing the procedure in the emergency department unnecessarily uses staff and resources reserved for patients with more critical illnesses. Ob.gyns. should also work with emergency medicine physicians and emergency department nursing staff and hospital administrators in explaining that MVA in the emergency room is patient centered and cost effective.
Interdisciplinary collaboration and training are two strategies that can increase access to mifepristone and MVA for EPL management. Use of mifepristone/misoprostol and office/emergency department MVA for treatment of EPL is patient centered, evidence based, feasible, highly effective, and timely. These two health care interventions are practical in almost any setting, including rural and other low-resource settings. By using these strategies to overcome the logistical and institutional challenges, ob.gyns. can help countless women with EPL gain access to the best EPL care.
Dr. Espey is chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Jackson is an obstetrician/gynecologist at Michigan State University in Flint. They have no disclosures to report.
References
1. Schreiber CA et al. N Engl J Med. 2018 Jun 7;378(23):2161-70.
2. Food and Drug Administration. Mifeprex (mifepristone) information.
3. The TEAMM (Training, Education, and Advocacy in Miscarriage Management) Project. Training interprofessional teams to manage miscarriage. Accessed March 15, 2021.
4. Quinley KE et al. Ann Emerg Med. 2019 Jul;72(1):86-92.
5. Milingos DS et al. BJOG. 2009 Aug;116(9):1268-71.
6. Calloway D et al. Contraception. 2021 Jul;104(1):24-8.
Remarkable advances in care for early pregnancy loss (EPL) have occurred over the past several years. Misoprostol with mifepristone pretreatment is now the gold standard for medical management after recent research showed that this regimen improves both the efficacy and cost-effectiveness of medical management.1 Manual vacuum aspiration (MVA)’s portability, effectiveness, and safety ensure that providers can offer procedural EPL management in almost any clinical setting. Medication management and in-office uterine aspiration are two evidence-based options for EPL management that may increase access for the 25% of pregnant women who experience EPL. Unfortunately, many women do not have access to either option. Equitable access to early pregnancy loss management can be achieved by expanding access to mifepristone and office-based MVA.
However, access to mifepristone and initiating office-based MVA is challenging. Mifepristone is one of several medications regulated under the Food and Drug Administration’s Risk Evaluation and Management Strategies (REMS) program.2
The REMS guidelines restrict clinicians in prescribing and dispensing mifepristone, including the key provision that mifepristone may be dispensed only in clinics, medical offices, and hospitals. Clinicians cannot write a prescription for mifepristone for a patient to pick up at the pharmacy. Efforts are underway to roll back the REMS. Barriers to office-based MVA include time, culture shift among staff, gathering equipment, and creating protocols. Clinicians can improve access to EPL management in a variety of ways:
- MVA training: Ob.gyns. who lack training in MVA use can take advantage of several programs designed to teach the skill to clinicians, including programs such as Training, Education, and Advocacy in Miscarriage Management (TEAMM).3,4 MVA is easy to learn for ob.gyns. and procedural complications are uncommon. In the office setting, complications requiring transfer to a higher level of care are rare.5 With adequate training, whether during residency or afterward, ob.gyns. can learn to safely and effectively use MVA for procedural EPL management in the office and in the emergency department.
- Partnerships with pharmacists to reduce barriers to mifepristone: Ob.gyns. working in a variety of clinical settings, including independent clinics, critical access hospitals, community hospitals, and academic medical centers, have worked closely with on-site pharmacists to place mifepristone on their practice sites’ formularies.6 These ob.gyn.–pharmacist collaborations often require explanations to institutional Pharmacy and Therapeutics (P&T) committees of the benefits of mifepristone to patients, detailed indications for mifepristone’s use, and methods to secure mifepristone on site.
- Partnerships with emergency department and outpatient nursing and administration to promote MVA: Provision of MVA is ideal for safe, effective, and cost-efficient procedural EPL management in both the emergency department and outpatient setting. However, access to MVA in emergency rooms and outpatient clinical settings is suboptimal. Some clinicians push back against MVA use in the emergency department, citing fears that performing the procedure in the emergency department unnecessarily uses staff and resources reserved for patients with more critical illnesses. Ob.gyns. should also work with emergency medicine physicians and emergency department nursing staff and hospital administrators in explaining that MVA in the emergency room is patient centered and cost effective.
Interdisciplinary collaboration and training are two strategies that can increase access to mifepristone and MVA for EPL management. Use of mifepristone/misoprostol and office/emergency department MVA for treatment of EPL is patient centered, evidence based, feasible, highly effective, and timely. These two health care interventions are practical in almost any setting, including rural and other low-resource settings. By using these strategies to overcome the logistical and institutional challenges, ob.gyns. can help countless women with EPL gain access to the best EPL care.
Dr. Espey is chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Jackson is an obstetrician/gynecologist at Michigan State University in Flint. They have no disclosures to report.
References
1. Schreiber CA et al. N Engl J Med. 2018 Jun 7;378(23):2161-70.
2. Food and Drug Administration. Mifeprex (mifepristone) information.
3. The TEAMM (Training, Education, and Advocacy in Miscarriage Management) Project. Training interprofessional teams to manage miscarriage. Accessed March 15, 2021.
4. Quinley KE et al. Ann Emerg Med. 2019 Jul;72(1):86-92.
5. Milingos DS et al. BJOG. 2009 Aug;116(9):1268-71.
6. Calloway D et al. Contraception. 2021 Jul;104(1):24-8.
Remarkable advances in care for early pregnancy loss (EPL) have occurred over the past several years. Misoprostol with mifepristone pretreatment is now the gold standard for medical management after recent research showed that this regimen improves both the efficacy and cost-effectiveness of medical management.1 Manual vacuum aspiration (MVA)’s portability, effectiveness, and safety ensure that providers can offer procedural EPL management in almost any clinical setting. Medication management and in-office uterine aspiration are two evidence-based options for EPL management that may increase access for the 25% of pregnant women who experience EPL. Unfortunately, many women do not have access to either option. Equitable access to early pregnancy loss management can be achieved by expanding access to mifepristone and office-based MVA.
However, access to mifepristone and initiating office-based MVA is challenging. Mifepristone is one of several medications regulated under the Food and Drug Administration’s Risk Evaluation and Management Strategies (REMS) program.2
The REMS guidelines restrict clinicians in prescribing and dispensing mifepristone, including the key provision that mifepristone may be dispensed only in clinics, medical offices, and hospitals. Clinicians cannot write a prescription for mifepristone for a patient to pick up at the pharmacy. Efforts are underway to roll back the REMS. Barriers to office-based MVA include time, culture shift among staff, gathering equipment, and creating protocols. Clinicians can improve access to EPL management in a variety of ways:
- MVA training: Ob.gyns. who lack training in MVA use can take advantage of several programs designed to teach the skill to clinicians, including programs such as Training, Education, and Advocacy in Miscarriage Management (TEAMM).3,4 MVA is easy to learn for ob.gyns. and procedural complications are uncommon. In the office setting, complications requiring transfer to a higher level of care are rare.5 With adequate training, whether during residency or afterward, ob.gyns. can learn to safely and effectively use MVA for procedural EPL management in the office and in the emergency department.
- Partnerships with pharmacists to reduce barriers to mifepristone: Ob.gyns. working in a variety of clinical settings, including independent clinics, critical access hospitals, community hospitals, and academic medical centers, have worked closely with on-site pharmacists to place mifepristone on their practice sites’ formularies.6 These ob.gyn.–pharmacist collaborations often require explanations to institutional Pharmacy and Therapeutics (P&T) committees of the benefits of mifepristone to patients, detailed indications for mifepristone’s use, and methods to secure mifepristone on site.
- Partnerships with emergency department and outpatient nursing and administration to promote MVA: Provision of MVA is ideal for safe, effective, and cost-efficient procedural EPL management in both the emergency department and outpatient setting. However, access to MVA in emergency rooms and outpatient clinical settings is suboptimal. Some clinicians push back against MVA use in the emergency department, citing fears that performing the procedure in the emergency department unnecessarily uses staff and resources reserved for patients with more critical illnesses. Ob.gyns. should also work with emergency medicine physicians and emergency department nursing staff and hospital administrators in explaining that MVA in the emergency room is patient centered and cost effective.
Interdisciplinary collaboration and training are two strategies that can increase access to mifepristone and MVA for EPL management. Use of mifepristone/misoprostol and office/emergency department MVA for treatment of EPL is patient centered, evidence based, feasible, highly effective, and timely. These two health care interventions are practical in almost any setting, including rural and other low-resource settings. By using these strategies to overcome the logistical and institutional challenges, ob.gyns. can help countless women with EPL gain access to the best EPL care.
Dr. Espey is chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Jackson is an obstetrician/gynecologist at Michigan State University in Flint. They have no disclosures to report.
References
1. Schreiber CA et al. N Engl J Med. 2018 Jun 7;378(23):2161-70.
2. Food and Drug Administration. Mifeprex (mifepristone) information.
3. The TEAMM (Training, Education, and Advocacy in Miscarriage Management) Project. Training interprofessional teams to manage miscarriage. Accessed March 15, 2021.
4. Quinley KE et al. Ann Emerg Med. 2019 Jul;72(1):86-92.
5. Milingos DS et al. BJOG. 2009 Aug;116(9):1268-71.
6. Calloway D et al. Contraception. 2021 Jul;104(1):24-8.
Remdesivir sharply cuts COVID hospitalization risk, Gilead says
Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.
Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.
Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.
Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.
The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.
A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
Use of remdesivir controversial
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.
However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.
The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.
The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.
A version of this article first appeared on Medscape.com.
Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.
Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.
Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.
Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.
The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.
A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
Use of remdesivir controversial
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.
However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.
The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.
The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.
A version of this article first appeared on Medscape.com.
Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.
Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.
Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.
Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.
The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.
A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
Use of remdesivir controversial
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.
However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.
The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.
The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.
A version of this article first appeared on Medscape.com.
Rare hematologic malignancy may first present to a dermatologist
in about 80% of cases.
“You won’t see blastic plasmacytoid dendritic cell neoplasm listed on our primary cutaneous lymphoma classifications because it’s not technically a primary cutaneous disease,” Brittney K. DeClerck, MD, said during the annual meeting of the Pacific Dermatologic Association. “It’s a systemic disease that has secondary cutaneous manifestations. That’s a very important distinction to make, in terms of not missing the underlying disease associated with what might be commonly first seen on the skin.”
BPDCN is a malignancy of plasmacytoid dendritic cells, which capture, process, and present antigen, and allow the remainder of the immune system to be activated. “They are mainly derived from the myeloid cell lineage, and possibly from the lymphoid line in a subset of cases,” said Dr. DeClerck, associate professor of clinical pathology and dermatology at the University of Southern California, Los Angeles. “They secrete high levels of type I interferons, which is important for antiviral immunity, but they can also be implicated in severe systemic inflammatory diseases, such as systemic lupus erythematosus and systemic sclerosis.”
BPDCN involves the skin in about 80% of cases, she added, “but invariably at some point it involves the bone marrow and has an acute leukemic presentation, whether or not it happens concurrently with what we see on the skin as dermatologists. We also see variable involvement of the peripheral blood, lymph nodes, and the central nervous system.”
The classification of BPDCN has changed over time based on evolving immunohistochemical markers and technologies. For example, in 1995 it was called agranular CD4+ NK cell leukemia, in 2001 it was called blastic NK-cell lymphoma, in 2005 it was called CD4+/CD56+ hematodermic neoplasm, and in 2008 it was called BPDCN (AML subset). In 2016 it became classified as its own entity: BPDCN.
Because of changing nomenclature, the true incidence of the disease is unknown, but according to the best available literature, 75% of cases occur in men and the median age is between 60 and 70 years, “but all ages can be affected,” Dr. DeClerck said. “Cases seem to come in clusters. Our most recent cluster has been in our pediatric population. At Children’s Hospital Los Angeles, we’ve had three cases in the last couple of years. To me, that was a bit unusual.”
She added that 10%-20% of patients will have either a history of, or will develop another, hematologic malignancy, such as myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), or acute myelogenous leukemia (AML).
The general prognosis of BPDCN is poor, and the mean time from onset of lesions to an actual diagnosis is about 6.2 months, which underscores the importance of early diagnosis, Dr. DeClerck said. “There can be some nondescript solitary lesions that patients can present with, so don’t hesitate to biopsy.” The median overall survival is less than 20 months, but patients under 60 years of age have a slightly better prognosis.
Clinical presentation
Clinically, the malignancy presents with variable involvement of the skin, bone marrow, lymph nodes, peripheral blood, and central nervous system. “Patients may have one or all of these,” she said. Because 80% of patients have skin lesions, “dermatologists should be aware of this entity in order to communicate with our pathologists to understand that maybe one biopsy isn’t enough. Several biopsies may be required.”
The most common dermatologic presentation of BPDCN is erythematous to deeply violaceous nodules. Other patients may present with infiltrated ecchymotic plaques or petechial to hyperpigmented macules, patches, and plaques. Biopsy reveals a diffusely infiltrated dermis of markedly atypical large cells, but occasionally can be more subtle. “Early lesions may only be perivascular in nature, so going on high power on anything that looks atypical on low power is important in these cases,” Dr. DeClerck said.
The recommended histochemical stains for suspected BPDCN include CD123, CD4, and CD56. “We need to have other stains to rule out other things, such as negative stains that are going to exclude other T cell and B cell processes, and Merkel cell carcinoma, which can express CD56. We also want to have another confirmatory stain because other things can express CD123, CD4, and CD56. Commonly we use TCL1 or TCF4.”
The differential diagnosis of cutaneous findings includes leukemia cutis, mycosis fungoides, NK/T-cell lymphoma, and cutaneous gamma-delta T-cell lymphoma, while the differential diagnosis of biopsy findings includes AML, acute lymphoblastic leukemia, and NK/T-cell lymphoma.
Treatment of BPDCN
Historically, BPDCN was treated with multiagent high-dose chemotherapy. “Patients would frequently respond early but would relapse quickly, progress, and have a poor outcome,” Dr. DeClerck said. Now, first-line therapy is tagraxofusp-erzs (Elzonris) or multiagent chemotherapy based on where the patient is in the course of disease. Tagraxofusp-erzs is an IL-3 conjugated diphtheria toxic fusion protein which binds to CD123, which was approved by the Food and Drug Administration in 2018 for treating BPDCN. After that initial therapy, it is determined whether the patient has a complete response or failed response, she said. “If they have a complete response, they frequently go on to bone marrow transplantation, which is the only curative therapy at this point for these patients.”
According to Dr. DeClerck, an anti-BCL-2 therapy, venetoclax, can be used for patients with BPDCN as well. National Comprehensive Cancer Network (NCCN) guidelines for the treatment of BPDCN can be found on the NCCN website.
Dr. DeClerck emphasized the importance of reviewing biopsy results with a hematopathologist, “because there are complex leukemias that are beyond what dermatopathologists have been trained in.” Once a patient is diagnosed with BPDCN, she recommends rapid referral to a large center for treatment and possible bone marrow transplantation.
Dr. DeClerck disclosed that she is an adviser for tagraxofusp-erzs manufacturer Stemline Therapeutics.
in about 80% of cases.
“You won’t see blastic plasmacytoid dendritic cell neoplasm listed on our primary cutaneous lymphoma classifications because it’s not technically a primary cutaneous disease,” Brittney K. DeClerck, MD, said during the annual meeting of the Pacific Dermatologic Association. “It’s a systemic disease that has secondary cutaneous manifestations. That’s a very important distinction to make, in terms of not missing the underlying disease associated with what might be commonly first seen on the skin.”
BPDCN is a malignancy of plasmacytoid dendritic cells, which capture, process, and present antigen, and allow the remainder of the immune system to be activated. “They are mainly derived from the myeloid cell lineage, and possibly from the lymphoid line in a subset of cases,” said Dr. DeClerck, associate professor of clinical pathology and dermatology at the University of Southern California, Los Angeles. “They secrete high levels of type I interferons, which is important for antiviral immunity, but they can also be implicated in severe systemic inflammatory diseases, such as systemic lupus erythematosus and systemic sclerosis.”
BPDCN involves the skin in about 80% of cases, she added, “but invariably at some point it involves the bone marrow and has an acute leukemic presentation, whether or not it happens concurrently with what we see on the skin as dermatologists. We also see variable involvement of the peripheral blood, lymph nodes, and the central nervous system.”
The classification of BPDCN has changed over time based on evolving immunohistochemical markers and technologies. For example, in 1995 it was called agranular CD4+ NK cell leukemia, in 2001 it was called blastic NK-cell lymphoma, in 2005 it was called CD4+/CD56+ hematodermic neoplasm, and in 2008 it was called BPDCN (AML subset). In 2016 it became classified as its own entity: BPDCN.
Because of changing nomenclature, the true incidence of the disease is unknown, but according to the best available literature, 75% of cases occur in men and the median age is between 60 and 70 years, “but all ages can be affected,” Dr. DeClerck said. “Cases seem to come in clusters. Our most recent cluster has been in our pediatric population. At Children’s Hospital Los Angeles, we’ve had three cases in the last couple of years. To me, that was a bit unusual.”
She added that 10%-20% of patients will have either a history of, or will develop another, hematologic malignancy, such as myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), or acute myelogenous leukemia (AML).
The general prognosis of BPDCN is poor, and the mean time from onset of lesions to an actual diagnosis is about 6.2 months, which underscores the importance of early diagnosis, Dr. DeClerck said. “There can be some nondescript solitary lesions that patients can present with, so don’t hesitate to biopsy.” The median overall survival is less than 20 months, but patients under 60 years of age have a slightly better prognosis.
Clinical presentation
Clinically, the malignancy presents with variable involvement of the skin, bone marrow, lymph nodes, peripheral blood, and central nervous system. “Patients may have one or all of these,” she said. Because 80% of patients have skin lesions, “dermatologists should be aware of this entity in order to communicate with our pathologists to understand that maybe one biopsy isn’t enough. Several biopsies may be required.”
The most common dermatologic presentation of BPDCN is erythematous to deeply violaceous nodules. Other patients may present with infiltrated ecchymotic plaques or petechial to hyperpigmented macules, patches, and plaques. Biopsy reveals a diffusely infiltrated dermis of markedly atypical large cells, but occasionally can be more subtle. “Early lesions may only be perivascular in nature, so going on high power on anything that looks atypical on low power is important in these cases,” Dr. DeClerck said.
The recommended histochemical stains for suspected BPDCN include CD123, CD4, and CD56. “We need to have other stains to rule out other things, such as negative stains that are going to exclude other T cell and B cell processes, and Merkel cell carcinoma, which can express CD56. We also want to have another confirmatory stain because other things can express CD123, CD4, and CD56. Commonly we use TCL1 or TCF4.”
The differential diagnosis of cutaneous findings includes leukemia cutis, mycosis fungoides, NK/T-cell lymphoma, and cutaneous gamma-delta T-cell lymphoma, while the differential diagnosis of biopsy findings includes AML, acute lymphoblastic leukemia, and NK/T-cell lymphoma.
Treatment of BPDCN
Historically, BPDCN was treated with multiagent high-dose chemotherapy. “Patients would frequently respond early but would relapse quickly, progress, and have a poor outcome,” Dr. DeClerck said. Now, first-line therapy is tagraxofusp-erzs (Elzonris) or multiagent chemotherapy based on where the patient is in the course of disease. Tagraxofusp-erzs is an IL-3 conjugated diphtheria toxic fusion protein which binds to CD123, which was approved by the Food and Drug Administration in 2018 for treating BPDCN. After that initial therapy, it is determined whether the patient has a complete response or failed response, she said. “If they have a complete response, they frequently go on to bone marrow transplantation, which is the only curative therapy at this point for these patients.”
According to Dr. DeClerck, an anti-BCL-2 therapy, venetoclax, can be used for patients with BPDCN as well. National Comprehensive Cancer Network (NCCN) guidelines for the treatment of BPDCN can be found on the NCCN website.
Dr. DeClerck emphasized the importance of reviewing biopsy results with a hematopathologist, “because there are complex leukemias that are beyond what dermatopathologists have been trained in.” Once a patient is diagnosed with BPDCN, she recommends rapid referral to a large center for treatment and possible bone marrow transplantation.
Dr. DeClerck disclosed that she is an adviser for tagraxofusp-erzs manufacturer Stemline Therapeutics.
in about 80% of cases.
“You won’t see blastic plasmacytoid dendritic cell neoplasm listed on our primary cutaneous lymphoma classifications because it’s not technically a primary cutaneous disease,” Brittney K. DeClerck, MD, said during the annual meeting of the Pacific Dermatologic Association. “It’s a systemic disease that has secondary cutaneous manifestations. That’s a very important distinction to make, in terms of not missing the underlying disease associated with what might be commonly first seen on the skin.”
BPDCN is a malignancy of plasmacytoid dendritic cells, which capture, process, and present antigen, and allow the remainder of the immune system to be activated. “They are mainly derived from the myeloid cell lineage, and possibly from the lymphoid line in a subset of cases,” said Dr. DeClerck, associate professor of clinical pathology and dermatology at the University of Southern California, Los Angeles. “They secrete high levels of type I interferons, which is important for antiviral immunity, but they can also be implicated in severe systemic inflammatory diseases, such as systemic lupus erythematosus and systemic sclerosis.”
BPDCN involves the skin in about 80% of cases, she added, “but invariably at some point it involves the bone marrow and has an acute leukemic presentation, whether or not it happens concurrently with what we see on the skin as dermatologists. We also see variable involvement of the peripheral blood, lymph nodes, and the central nervous system.”
The classification of BPDCN has changed over time based on evolving immunohistochemical markers and technologies. For example, in 1995 it was called agranular CD4+ NK cell leukemia, in 2001 it was called blastic NK-cell lymphoma, in 2005 it was called CD4+/CD56+ hematodermic neoplasm, and in 2008 it was called BPDCN (AML subset). In 2016 it became classified as its own entity: BPDCN.
Because of changing nomenclature, the true incidence of the disease is unknown, but according to the best available literature, 75% of cases occur in men and the median age is between 60 and 70 years, “but all ages can be affected,” Dr. DeClerck said. “Cases seem to come in clusters. Our most recent cluster has been in our pediatric population. At Children’s Hospital Los Angeles, we’ve had three cases in the last couple of years. To me, that was a bit unusual.”
She added that 10%-20% of patients will have either a history of, or will develop another, hematologic malignancy, such as myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), or acute myelogenous leukemia (AML).
The general prognosis of BPDCN is poor, and the mean time from onset of lesions to an actual diagnosis is about 6.2 months, which underscores the importance of early diagnosis, Dr. DeClerck said. “There can be some nondescript solitary lesions that patients can present with, so don’t hesitate to biopsy.” The median overall survival is less than 20 months, but patients under 60 years of age have a slightly better prognosis.
Clinical presentation
Clinically, the malignancy presents with variable involvement of the skin, bone marrow, lymph nodes, peripheral blood, and central nervous system. “Patients may have one or all of these,” she said. Because 80% of patients have skin lesions, “dermatologists should be aware of this entity in order to communicate with our pathologists to understand that maybe one biopsy isn’t enough. Several biopsies may be required.”
The most common dermatologic presentation of BPDCN is erythematous to deeply violaceous nodules. Other patients may present with infiltrated ecchymotic plaques or petechial to hyperpigmented macules, patches, and plaques. Biopsy reveals a diffusely infiltrated dermis of markedly atypical large cells, but occasionally can be more subtle. “Early lesions may only be perivascular in nature, so going on high power on anything that looks atypical on low power is important in these cases,” Dr. DeClerck said.
The recommended histochemical stains for suspected BPDCN include CD123, CD4, and CD56. “We need to have other stains to rule out other things, such as negative stains that are going to exclude other T cell and B cell processes, and Merkel cell carcinoma, which can express CD56. We also want to have another confirmatory stain because other things can express CD123, CD4, and CD56. Commonly we use TCL1 or TCF4.”
The differential diagnosis of cutaneous findings includes leukemia cutis, mycosis fungoides, NK/T-cell lymphoma, and cutaneous gamma-delta T-cell lymphoma, while the differential diagnosis of biopsy findings includes AML, acute lymphoblastic leukemia, and NK/T-cell lymphoma.
Treatment of BPDCN
Historically, BPDCN was treated with multiagent high-dose chemotherapy. “Patients would frequently respond early but would relapse quickly, progress, and have a poor outcome,” Dr. DeClerck said. Now, first-line therapy is tagraxofusp-erzs (Elzonris) or multiagent chemotherapy based on where the patient is in the course of disease. Tagraxofusp-erzs is an IL-3 conjugated diphtheria toxic fusion protein which binds to CD123, which was approved by the Food and Drug Administration in 2018 for treating BPDCN. After that initial therapy, it is determined whether the patient has a complete response or failed response, she said. “If they have a complete response, they frequently go on to bone marrow transplantation, which is the only curative therapy at this point for these patients.”
According to Dr. DeClerck, an anti-BCL-2 therapy, venetoclax, can be used for patients with BPDCN as well. National Comprehensive Cancer Network (NCCN) guidelines for the treatment of BPDCN can be found on the NCCN website.
Dr. DeClerck emphasized the importance of reviewing biopsy results with a hematopathologist, “because there are complex leukemias that are beyond what dermatopathologists have been trained in.” Once a patient is diagnosed with BPDCN, she recommends rapid referral to a large center for treatment and possible bone marrow transplantation.
Dr. DeClerck disclosed that she is an adviser for tagraxofusp-erzs manufacturer Stemline Therapeutics.
FROM PDA 2021
Dopamine and reward: The story of social media
How often do you find yourself on social media? The first thing I do when I wake up is check my email and text messages, as well as my Facebook, Snapchat, and Instagram notifications.
Some 150,000 messages are shared on Facebook each minute; 293 million daily active users worldwide were recorded on Snapchat during the second quarter of 2021; 127.2 million monthly active users in the United States are projected to be on Instagram by 2023.
Social media has gained the hearts and wonder of many around the world. It’s absolutely incredible how ingrained it has become in our lives as a medium for creativity, outlet for communication, and platform for information. In fact, these online network tools have now become essential during COVID-19 to ensure productive workflow, keep in touch with our loved ones, and, overall, maintain social capital. Social media has truly emerged as a powerful form of living beyond our physical selves.
Yet, increased (and addictive) social media use is associated with negative health outcomes, especially among adolescents. For example, in a study reporting parent and adolescent accounts of social media use, it was reported that social media use was associated with hyperactivity/impulsivity, depression, anxiety, loneliness, and a fear of missing out. Furthermore, a meta-analysis investigating the relationship between social media use and depressive symptoms among adolescents found a small but significant and positive relationship between the two. However, additional research is required to elucidate this association.
Notwithstanding, the addictive nature of social media has previously been called out as analogous to the addictive nature of gambling. Let’s think about it. Whether you’re on Instagram, TikTok, or a similar platform, you can’t help but scroll from one video to the next. It’s one 5- to 10-second video after the next, and before you know it, you’ve spent the past hour going through random videos – but you can’t stop. Why is that so?
Social media actually “rewires” our brain such that we expect instant gratification. In other words, when we get a notification, message, like, or share, we expect fast and short-term pleasure/reward because the brain will produce a “hit of dopamine.” However, it is important to note that the reward system is not delimited to the dopaminergic pathway and, in fact, should be understood as a complex network system (i.e., governed by changes in brain morphology through addiction and excessive behavior). Given the quick pace of the social media world, the reward pathways in our brain change and there’s an increasing demand for attention, perpetuating an addictive mindset.
When we refresh our page, we expect instant gratification. But what happens when we don’t get a like, or a message, or some sort of “reward”? Recounts of social media use by adolescents have likened online attention to popularity. Accordingly, a lack of constant attention on social media has created a vicious cycle of anxiety, loneliness, and depression because of a failure to receive “virtual” reward. Taken together, social media may be harmful because it distorts our self-image, and while social media platforms help connect us, they can also ironically make us feel isolated, lower our self-confidence, and diminish our overall sense of well-being.
As the platforms for communication and information have evolved so rapidly over the past decade, there is a need to establish boundaries between what is beneficial and what is potentially detrimental to our mental health. While social media companies should play a role in mitigating addictive social network behavior, it would also seem counterintuitive to the general business model. In that case, who takes charge? This multifaceted problem requires a multidisciplinary approach.
Leanna M.W. Lui is an MSc candidate at the University of Toronto.
A version of this article first appeared on Medscape.com.
How often do you find yourself on social media? The first thing I do when I wake up is check my email and text messages, as well as my Facebook, Snapchat, and Instagram notifications.
Some 150,000 messages are shared on Facebook each minute; 293 million daily active users worldwide were recorded on Snapchat during the second quarter of 2021; 127.2 million monthly active users in the United States are projected to be on Instagram by 2023.
Social media has gained the hearts and wonder of many around the world. It’s absolutely incredible how ingrained it has become in our lives as a medium for creativity, outlet for communication, and platform for information. In fact, these online network tools have now become essential during COVID-19 to ensure productive workflow, keep in touch with our loved ones, and, overall, maintain social capital. Social media has truly emerged as a powerful form of living beyond our physical selves.
Yet, increased (and addictive) social media use is associated with negative health outcomes, especially among adolescents. For example, in a study reporting parent and adolescent accounts of social media use, it was reported that social media use was associated with hyperactivity/impulsivity, depression, anxiety, loneliness, and a fear of missing out. Furthermore, a meta-analysis investigating the relationship between social media use and depressive symptoms among adolescents found a small but significant and positive relationship between the two. However, additional research is required to elucidate this association.
Notwithstanding, the addictive nature of social media has previously been called out as analogous to the addictive nature of gambling. Let’s think about it. Whether you’re on Instagram, TikTok, or a similar platform, you can’t help but scroll from one video to the next. It’s one 5- to 10-second video after the next, and before you know it, you’ve spent the past hour going through random videos – but you can’t stop. Why is that so?
Social media actually “rewires” our brain such that we expect instant gratification. In other words, when we get a notification, message, like, or share, we expect fast and short-term pleasure/reward because the brain will produce a “hit of dopamine.” However, it is important to note that the reward system is not delimited to the dopaminergic pathway and, in fact, should be understood as a complex network system (i.e., governed by changes in brain morphology through addiction and excessive behavior). Given the quick pace of the social media world, the reward pathways in our brain change and there’s an increasing demand for attention, perpetuating an addictive mindset.
When we refresh our page, we expect instant gratification. But what happens when we don’t get a like, or a message, or some sort of “reward”? Recounts of social media use by adolescents have likened online attention to popularity. Accordingly, a lack of constant attention on social media has created a vicious cycle of anxiety, loneliness, and depression because of a failure to receive “virtual” reward. Taken together, social media may be harmful because it distorts our self-image, and while social media platforms help connect us, they can also ironically make us feel isolated, lower our self-confidence, and diminish our overall sense of well-being.
As the platforms for communication and information have evolved so rapidly over the past decade, there is a need to establish boundaries between what is beneficial and what is potentially detrimental to our mental health. While social media companies should play a role in mitigating addictive social network behavior, it would also seem counterintuitive to the general business model. In that case, who takes charge? This multifaceted problem requires a multidisciplinary approach.
Leanna M.W. Lui is an MSc candidate at the University of Toronto.
A version of this article first appeared on Medscape.com.
How often do you find yourself on social media? The first thing I do when I wake up is check my email and text messages, as well as my Facebook, Snapchat, and Instagram notifications.
Some 150,000 messages are shared on Facebook each minute; 293 million daily active users worldwide were recorded on Snapchat during the second quarter of 2021; 127.2 million monthly active users in the United States are projected to be on Instagram by 2023.
Social media has gained the hearts and wonder of many around the world. It’s absolutely incredible how ingrained it has become in our lives as a medium for creativity, outlet for communication, and platform for information. In fact, these online network tools have now become essential during COVID-19 to ensure productive workflow, keep in touch with our loved ones, and, overall, maintain social capital. Social media has truly emerged as a powerful form of living beyond our physical selves.
Yet, increased (and addictive) social media use is associated with negative health outcomes, especially among adolescents. For example, in a study reporting parent and adolescent accounts of social media use, it was reported that social media use was associated with hyperactivity/impulsivity, depression, anxiety, loneliness, and a fear of missing out. Furthermore, a meta-analysis investigating the relationship between social media use and depressive symptoms among adolescents found a small but significant and positive relationship between the two. However, additional research is required to elucidate this association.
Notwithstanding, the addictive nature of social media has previously been called out as analogous to the addictive nature of gambling. Let’s think about it. Whether you’re on Instagram, TikTok, or a similar platform, you can’t help but scroll from one video to the next. It’s one 5- to 10-second video after the next, and before you know it, you’ve spent the past hour going through random videos – but you can’t stop. Why is that so?
Social media actually “rewires” our brain such that we expect instant gratification. In other words, when we get a notification, message, like, or share, we expect fast and short-term pleasure/reward because the brain will produce a “hit of dopamine.” However, it is important to note that the reward system is not delimited to the dopaminergic pathway and, in fact, should be understood as a complex network system (i.e., governed by changes in brain morphology through addiction and excessive behavior). Given the quick pace of the social media world, the reward pathways in our brain change and there’s an increasing demand for attention, perpetuating an addictive mindset.
When we refresh our page, we expect instant gratification. But what happens when we don’t get a like, or a message, or some sort of “reward”? Recounts of social media use by adolescents have likened online attention to popularity. Accordingly, a lack of constant attention on social media has created a vicious cycle of anxiety, loneliness, and depression because of a failure to receive “virtual” reward. Taken together, social media may be harmful because it distorts our self-image, and while social media platforms help connect us, they can also ironically make us feel isolated, lower our self-confidence, and diminish our overall sense of well-being.
As the platforms for communication and information have evolved so rapidly over the past decade, there is a need to establish boundaries between what is beneficial and what is potentially detrimental to our mental health. While social media companies should play a role in mitigating addictive social network behavior, it would also seem counterintuitive to the general business model. In that case, who takes charge? This multifaceted problem requires a multidisciplinary approach.
Leanna M.W. Lui is an MSc candidate at the University of Toronto.
A version of this article first appeared on Medscape.com.
Authors’ response
My co-authors and I appreciate the excellent comments regarding our Photo Rounds column, “Foot rash and joint pain,” and would like to provide some additional detail.
After our patient’s 27-day hospital stay, he was admitted to a rehabilitation center for continued inpatient physical therapy for 14 days due to weakness and deconditioning. Following his discharge from the rehabilitation center, the patient was still confined to a wheelchair. He was prescribed an oral prednisone taper (as mentioned in our article) and celecoxib 200 mg bid and referred for outpatient physical therapy. At a follow-up appointment with the rheumatologist, he received adalimumab 80 mg followed by 40 mg every other week, which led to improvement in his range of motion and pain. Two months after outpatient physical therapy, the patient was lost to follow-up.
We agree with Dr. Hahn et al that many of these patients with chlamydia-associated ReA become “long-haulers.” In medicine—especially when rare diseases are considered—we must often make decisions without perfect science. The studies referenced by Dr. Hahn et al suggest that combinations of doxycycline and rifampin or azithromycin and rifampin may treat not only chlamydial infection, but ReA and associated cutaneous disease, as well.1,2 While these studies are small in size, larger studies may never be funded. We agree that combination therapy should be considered in this population of patients.
Hannah R. Badon, MD
Ross L. Pearlman, MD
Robert T. Brodell, MD
Jackson, MS
1. Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004;31:1973-1980.
2. Carter JD, Espinoza LR, Inman RD, et al. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010;62:1298-1307. doi: 10.1002/art.27394
My co-authors and I appreciate the excellent comments regarding our Photo Rounds column, “Foot rash and joint pain,” and would like to provide some additional detail.
After our patient’s 27-day hospital stay, he was admitted to a rehabilitation center for continued inpatient physical therapy for 14 days due to weakness and deconditioning. Following his discharge from the rehabilitation center, the patient was still confined to a wheelchair. He was prescribed an oral prednisone taper (as mentioned in our article) and celecoxib 200 mg bid and referred for outpatient physical therapy. At a follow-up appointment with the rheumatologist, he received adalimumab 80 mg followed by 40 mg every other week, which led to improvement in his range of motion and pain. Two months after outpatient physical therapy, the patient was lost to follow-up.
We agree with Dr. Hahn et al that many of these patients with chlamydia-associated ReA become “long-haulers.” In medicine—especially when rare diseases are considered—we must often make decisions without perfect science. The studies referenced by Dr. Hahn et al suggest that combinations of doxycycline and rifampin or azithromycin and rifampin may treat not only chlamydial infection, but ReA and associated cutaneous disease, as well.1,2 While these studies are small in size, larger studies may never be funded. We agree that combination therapy should be considered in this population of patients.
Hannah R. Badon, MD
Ross L. Pearlman, MD
Robert T. Brodell, MD
Jackson, MS
My co-authors and I appreciate the excellent comments regarding our Photo Rounds column, “Foot rash and joint pain,” and would like to provide some additional detail.
After our patient’s 27-day hospital stay, he was admitted to a rehabilitation center for continued inpatient physical therapy for 14 days due to weakness and deconditioning. Following his discharge from the rehabilitation center, the patient was still confined to a wheelchair. He was prescribed an oral prednisone taper (as mentioned in our article) and celecoxib 200 mg bid and referred for outpatient physical therapy. At a follow-up appointment with the rheumatologist, he received adalimumab 80 mg followed by 40 mg every other week, which led to improvement in his range of motion and pain. Two months after outpatient physical therapy, the patient was lost to follow-up.
We agree with Dr. Hahn et al that many of these patients with chlamydia-associated ReA become “long-haulers.” In medicine—especially when rare diseases are considered—we must often make decisions without perfect science. The studies referenced by Dr. Hahn et al suggest that combinations of doxycycline and rifampin or azithromycin and rifampin may treat not only chlamydial infection, but ReA and associated cutaneous disease, as well.1,2 While these studies are small in size, larger studies may never be funded. We agree that combination therapy should be considered in this population of patients.
Hannah R. Badon, MD
Ross L. Pearlman, MD
Robert T. Brodell, MD
Jackson, MS
1. Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004;31:1973-1980.
2. Carter JD, Espinoza LR, Inman RD, et al. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010;62:1298-1307. doi: 10.1002/art.27394
1. Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004;31:1973-1980.
2. Carter JD, Espinoza LR, Inman RD, et al. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010;62:1298-1307. doi: 10.1002/art.27394
How best to treat “long-haulers” with reactive arthritis?
In the June Photo Rounds column, “Foot rash and joint pain” (J Fam Pract. 2021;70:249-251), Badon et al presented a case of chlamydia-associated reactive arthritis (ReA), formerly called Reiter syndrome, in a 21-year-old man following Chlamydia trachomatis urethritis. We would like to point out that, contrary to the conventional definition of ReA, in which the causative pathogen can’t be cultured from the affected joints,1 chlamydia-associated ReA is associated with evidence of chronic joint infection that, while not cultivable, can be confirmed by real-time polymerase chain reaction testing of metabolically active pathogens in synovial tissue and/or fluid.2
C trachomatis and C pneumoniae are the most frequent causative pathogens to elicit ReA.3 Short-course antibiotics and anti-inflammatory treatments can palliate ReA, but these treatments often do not provide a cure.3 Two controlled clinical trials demonstrated that chlamydia-associated ReA can be treated successfully with longer-term combination antibiotic therapy.4,5 ReA is usually diagnosed in the acute stage (first 6 months) and can become chronic in 30% of cases.6 It would be interesting to know the long-term treatment and outcome data for the case patient.
David L. Hahn, MD, MS
Alan P. Hudson, PhD
Charles Stratton, MD
Wilmore Webley, PhD
Judith Whittum-Hudson, PhD
1. Yu D, van Tubergenm A. Reactive arthritis. UpToDate. Updated 2021. Accessed August 10, 2021. www.uptodate.com/contents/reactive-arthritis
2. Gérard HC, Carter JD, Hudson AP. Chlamydia trachomatis is present and metabolically active during the remitting phase in synovial tissues from patients with chronic chlamydia-induced reactive arthritis. Am J Med Sci. 2013;346:22-25. doi: 10.1097/MAJ.0b013e3182648740
3. Zeidler H, Hudson AP. New insights into chlamydia and arthritis. Promise of a cure? Ann Rheum Dis. 2014;73:637-644. doi: 10.1136/annrheumdis-2013-204110
4. Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004;31:1973-1980.
5. Carter JD, Espinoza LR, Inman RD, et al. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010;62:1298-1307. doi: 10.1002/art.27394
6. Carter JD, Inman RD, Whittum-Hudson J, et al. Chlamydia and chronic arthritis. Ann Med. 2012;44:784-792. doi: 10.3109/07853890.2011.606830
In the June Photo Rounds column, “Foot rash and joint pain” (J Fam Pract. 2021;70:249-251), Badon et al presented a case of chlamydia-associated reactive arthritis (ReA), formerly called Reiter syndrome, in a 21-year-old man following Chlamydia trachomatis urethritis. We would like to point out that, contrary to the conventional definition of ReA, in which the causative pathogen can’t be cultured from the affected joints,1 chlamydia-associated ReA is associated with evidence of chronic joint infection that, while not cultivable, can be confirmed by real-time polymerase chain reaction testing of metabolically active pathogens in synovial tissue and/or fluid.2
C trachomatis and C pneumoniae are the most frequent causative pathogens to elicit ReA.3 Short-course antibiotics and anti-inflammatory treatments can palliate ReA, but these treatments often do not provide a cure.3 Two controlled clinical trials demonstrated that chlamydia-associated ReA can be treated successfully with longer-term combination antibiotic therapy.4,5 ReA is usually diagnosed in the acute stage (first 6 months) and can become chronic in 30% of cases.6 It would be interesting to know the long-term treatment and outcome data for the case patient.
David L. Hahn, MD, MS
Alan P. Hudson, PhD
Charles Stratton, MD
Wilmore Webley, PhD
Judith Whittum-Hudson, PhD
In the June Photo Rounds column, “Foot rash and joint pain” (J Fam Pract. 2021;70:249-251), Badon et al presented a case of chlamydia-associated reactive arthritis (ReA), formerly called Reiter syndrome, in a 21-year-old man following Chlamydia trachomatis urethritis. We would like to point out that, contrary to the conventional definition of ReA, in which the causative pathogen can’t be cultured from the affected joints,1 chlamydia-associated ReA is associated with evidence of chronic joint infection that, while not cultivable, can be confirmed by real-time polymerase chain reaction testing of metabolically active pathogens in synovial tissue and/or fluid.2
C trachomatis and C pneumoniae are the most frequent causative pathogens to elicit ReA.3 Short-course antibiotics and anti-inflammatory treatments can palliate ReA, but these treatments often do not provide a cure.3 Two controlled clinical trials demonstrated that chlamydia-associated ReA can be treated successfully with longer-term combination antibiotic therapy.4,5 ReA is usually diagnosed in the acute stage (first 6 months) and can become chronic in 30% of cases.6 It would be interesting to know the long-term treatment and outcome data for the case patient.
David L. Hahn, MD, MS
Alan P. Hudson, PhD
Charles Stratton, MD
Wilmore Webley, PhD
Judith Whittum-Hudson, PhD
1. Yu D, van Tubergenm A. Reactive arthritis. UpToDate. Updated 2021. Accessed August 10, 2021. www.uptodate.com/contents/reactive-arthritis
2. Gérard HC, Carter JD, Hudson AP. Chlamydia trachomatis is present and metabolically active during the remitting phase in synovial tissues from patients with chronic chlamydia-induced reactive arthritis. Am J Med Sci. 2013;346:22-25. doi: 10.1097/MAJ.0b013e3182648740
3. Zeidler H, Hudson AP. New insights into chlamydia and arthritis. Promise of a cure? Ann Rheum Dis. 2014;73:637-644. doi: 10.1136/annrheumdis-2013-204110
4. Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004;31:1973-1980.
5. Carter JD, Espinoza LR, Inman RD, et al. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010;62:1298-1307. doi: 10.1002/art.27394
6. Carter JD, Inman RD, Whittum-Hudson J, et al. Chlamydia and chronic arthritis. Ann Med. 2012;44:784-792. doi: 10.3109/07853890.2011.606830
1. Yu D, van Tubergenm A. Reactive arthritis. UpToDate. Updated 2021. Accessed August 10, 2021. www.uptodate.com/contents/reactive-arthritis
2. Gérard HC, Carter JD, Hudson AP. Chlamydia trachomatis is present and metabolically active during the remitting phase in synovial tissues from patients with chronic chlamydia-induced reactive arthritis. Am J Med Sci. 2013;346:22-25. doi: 10.1097/MAJ.0b013e3182648740
3. Zeidler H, Hudson AP. New insights into chlamydia and arthritis. Promise of a cure? Ann Rheum Dis. 2014;73:637-644. doi: 10.1136/annrheumdis-2013-204110
4. Carter JD, Valeriano J, Vasey FB. Doxycycline versus doxycycline and rifampin in undifferentiated spondyloarthropathy, with special reference to chlamydia-induced arthritis. A prospective, randomized 9-month comparison. J Rheumatol. 2004;31:1973-1980.
5. Carter JD, Espinoza LR, Inman RD, et al. Combination antibiotics as a treatment for chronic Chlamydia-induced reactive arthritis: a double-blind, placebo-controlled, prospective trial. Arthritis Rheum. 2010;62:1298-1307. doi: 10.1002/art.27394
6. Carter JD, Inman RD, Whittum-Hudson J, et al. Chlamydia and chronic arthritis. Ann Med. 2012;44:784-792. doi: 10.3109/07853890.2011.606830
Study identifies pandemic-related stressor in Parkinson’s disease
a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.
Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.
“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.
“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.
Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.
The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.
The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
Vulnerable subgroups
“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.
“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”
When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.
The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.
The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”
Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.
“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.
“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.
What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”
Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.
a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.
Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.
“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.
“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.
Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.
The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.
The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
Vulnerable subgroups
“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.
“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”
When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.
The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.
The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”
Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.
“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.
“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.
What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”
Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.
a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.
Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.
“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.
“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.
Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.
The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.
The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
Vulnerable subgroups
“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.
“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”
When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.
The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.
The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”
Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.
“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.
“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.
What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”
Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.
FROM MDS VIRTUAL CONGRESS 2021
Gastric cancer: Family history–based H. pylori strategy would be cost effective
Testing for and treating Helicobacter pylori infection among individuals with a family history of gastric cancer could be a cost-effective strategy in the United States, according to a new model published in the journal Gastroenterology.
As many as 10% of gastric cancers aggregate within families, though just why this happens is unclear, according to Sheila D. Rustgi, MD, and colleagues. Shared environmental or genetic factors, or combinations of both, may be responsible. First-degree family history and H. pylori infection each raise gastric cancer risk by roughly 2.5-fold.
In the United States, universal screening for H. pylori infection is not currently recommended, but some studies have suggested a possible benefit in some high-risk populations. American Gastroenterological Association clinical practice guidelines suggest that a patient’s family history should be a factor when considering surveillance strategies for intestinal metaplasia.
Furthermore, a study by Il Ju Choi, MD, and colleagues in 2020 showed that H. pylori treatment with bismuth-based quadruple therapy reduced the risk of gastric cancer by 73% among individuals with a first-degree relative who had gastric cancer. The combination included a proton pump inhibitor, bismuth, metronidazole, and tetracycline for 10 days.
“We hypothesize that, given the dramatic reduction in GC demonstrated by Choi et al., that the screening strategy can be a cost-effective intervention,” Dr. Rustgi and colleagues wrote.
In the new study, the researchers used a Markov state-transition mode, employing a hypothetical cohort of 40-year-old U.S. men and women with a first-degree relative with gastric cancer. It simulated a follow-up period of 60 years or until death. The model assumed a 7-day treatment with triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin) followed by a 14-day treatment period with quadruple therapy if needed. Although the model was analyzed from the U.S. perspective, the trial that informed the risk reduction was performed in a South Korean population.
No screening had a cost of $2,694.09 and resulted in 21.95 quality-adjusted life years (QALYs). 13C-Urea Breath Test screening had a cost of $2,105.28 and led to 22.37 QALYs. Stool antigen testing had a cost of $2,126.00 and yielded 22.30 QALYs.
In the no-screening group, an estimated 2.04% of patients would develop gastric cancer, and 1.82% would die of it. With screening, the frequency of gastric cancer dropped to 1.59%-1.65%, with a gastric cancer mortality rate of 1.41%-1.46%. Overall, screening was modeled to lead to a 19.1%-22.0% risk reduction.
The researchers validated their model by an assumption of an H. pylori infection rate of 100% and then compared the results of the model to the outcome of the study by Dr. Choi and colleagues. In the trial, there was a 55% reduction in gastric cancer among treated patients at a median of 9 years of follow-up. Those who had successful eradication of H. pylori had a 73% reduction. The new model estimated reductions from a testing and treatment strategy of 53.3%-64.5%.
The findings aren’t surprising, according to Joseph Jennings, MD, of the department of medicine at Georgetown University, Washington, and director of the Center for GI Bleeding at MedStar Georgetown University Hospital, who was not involved with the study. “Even eliminating one person getting gastric cancer, where they will then need major surgery, chemotherapy, all these very expensive interventions [is important],” said Dr. Jennings. “We have very efficient ways to test for these things that don’t involve endoscopy.”
One potential caveat to identifying and treating H. pylori infection is whether elimination of H. pylori may lead to some adverse effects. Some patients can experience increased acid reflux as a result, while others suffer no ill effects. “But when you’re dealing with the alternative, which is stomach cancer, those negatives would have to stack up really, really high to outweigh the positives of preventing a cancer that’s really hard to treat,” said Dr. Jennings.
Dr. Jennings pointed out that the model also projected testing and an intervention conducted in a South Korean population, and extrapolated it to a U.S. population, where the incidence of gastric cancer is lower. “There definitely are some questions about how well it would translate if applied to the general United States population,” said Dr. Jennings.
That question could prompt researchers to conduct a U.S.-based study modeled after the test and treat study in South Korea to see if the regimen produced similar results. The model should add weight to that argument, said Dr. Jennings: “This is raising the point that, at least from an intellectual level, it might be worth now designing the study to see if it works in our population,” said Dr. Jennings.
The authors and Dr. Jennings have no relevant financial disclosures.
Testing for and treating Helicobacter pylori infection among individuals with a family history of gastric cancer could be a cost-effective strategy in the United States, according to a new model published in the journal Gastroenterology.
As many as 10% of gastric cancers aggregate within families, though just why this happens is unclear, according to Sheila D. Rustgi, MD, and colleagues. Shared environmental or genetic factors, or combinations of both, may be responsible. First-degree family history and H. pylori infection each raise gastric cancer risk by roughly 2.5-fold.
In the United States, universal screening for H. pylori infection is not currently recommended, but some studies have suggested a possible benefit in some high-risk populations. American Gastroenterological Association clinical practice guidelines suggest that a patient’s family history should be a factor when considering surveillance strategies for intestinal metaplasia.
Furthermore, a study by Il Ju Choi, MD, and colleagues in 2020 showed that H. pylori treatment with bismuth-based quadruple therapy reduced the risk of gastric cancer by 73% among individuals with a first-degree relative who had gastric cancer. The combination included a proton pump inhibitor, bismuth, metronidazole, and tetracycline for 10 days.
“We hypothesize that, given the dramatic reduction in GC demonstrated by Choi et al., that the screening strategy can be a cost-effective intervention,” Dr. Rustgi and colleagues wrote.
In the new study, the researchers used a Markov state-transition mode, employing a hypothetical cohort of 40-year-old U.S. men and women with a first-degree relative with gastric cancer. It simulated a follow-up period of 60 years or until death. The model assumed a 7-day treatment with triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin) followed by a 14-day treatment period with quadruple therapy if needed. Although the model was analyzed from the U.S. perspective, the trial that informed the risk reduction was performed in a South Korean population.
No screening had a cost of $2,694.09 and resulted in 21.95 quality-adjusted life years (QALYs). 13C-Urea Breath Test screening had a cost of $2,105.28 and led to 22.37 QALYs. Stool antigen testing had a cost of $2,126.00 and yielded 22.30 QALYs.
In the no-screening group, an estimated 2.04% of patients would develop gastric cancer, and 1.82% would die of it. With screening, the frequency of gastric cancer dropped to 1.59%-1.65%, with a gastric cancer mortality rate of 1.41%-1.46%. Overall, screening was modeled to lead to a 19.1%-22.0% risk reduction.
The researchers validated their model by an assumption of an H. pylori infection rate of 100% and then compared the results of the model to the outcome of the study by Dr. Choi and colleagues. In the trial, there was a 55% reduction in gastric cancer among treated patients at a median of 9 years of follow-up. Those who had successful eradication of H. pylori had a 73% reduction. The new model estimated reductions from a testing and treatment strategy of 53.3%-64.5%.
The findings aren’t surprising, according to Joseph Jennings, MD, of the department of medicine at Georgetown University, Washington, and director of the Center for GI Bleeding at MedStar Georgetown University Hospital, who was not involved with the study. “Even eliminating one person getting gastric cancer, where they will then need major surgery, chemotherapy, all these very expensive interventions [is important],” said Dr. Jennings. “We have very efficient ways to test for these things that don’t involve endoscopy.”
One potential caveat to identifying and treating H. pylori infection is whether elimination of H. pylori may lead to some adverse effects. Some patients can experience increased acid reflux as a result, while others suffer no ill effects. “But when you’re dealing with the alternative, which is stomach cancer, those negatives would have to stack up really, really high to outweigh the positives of preventing a cancer that’s really hard to treat,” said Dr. Jennings.
Dr. Jennings pointed out that the model also projected testing and an intervention conducted in a South Korean population, and extrapolated it to a U.S. population, where the incidence of gastric cancer is lower. “There definitely are some questions about how well it would translate if applied to the general United States population,” said Dr. Jennings.
That question could prompt researchers to conduct a U.S.-based study modeled after the test and treat study in South Korea to see if the regimen produced similar results. The model should add weight to that argument, said Dr. Jennings: “This is raising the point that, at least from an intellectual level, it might be worth now designing the study to see if it works in our population,” said Dr. Jennings.
The authors and Dr. Jennings have no relevant financial disclosures.
Testing for and treating Helicobacter pylori infection among individuals with a family history of gastric cancer could be a cost-effective strategy in the United States, according to a new model published in the journal Gastroenterology.
As many as 10% of gastric cancers aggregate within families, though just why this happens is unclear, according to Sheila D. Rustgi, MD, and colleagues. Shared environmental or genetic factors, or combinations of both, may be responsible. First-degree family history and H. pylori infection each raise gastric cancer risk by roughly 2.5-fold.
In the United States, universal screening for H. pylori infection is not currently recommended, but some studies have suggested a possible benefit in some high-risk populations. American Gastroenterological Association clinical practice guidelines suggest that a patient’s family history should be a factor when considering surveillance strategies for intestinal metaplasia.
Furthermore, a study by Il Ju Choi, MD, and colleagues in 2020 showed that H. pylori treatment with bismuth-based quadruple therapy reduced the risk of gastric cancer by 73% among individuals with a first-degree relative who had gastric cancer. The combination included a proton pump inhibitor, bismuth, metronidazole, and tetracycline for 10 days.
“We hypothesize that, given the dramatic reduction in GC demonstrated by Choi et al., that the screening strategy can be a cost-effective intervention,” Dr. Rustgi and colleagues wrote.
In the new study, the researchers used a Markov state-transition mode, employing a hypothetical cohort of 40-year-old U.S. men and women with a first-degree relative with gastric cancer. It simulated a follow-up period of 60 years or until death. The model assumed a 7-day treatment with triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin) followed by a 14-day treatment period with quadruple therapy if needed. Although the model was analyzed from the U.S. perspective, the trial that informed the risk reduction was performed in a South Korean population.
No screening had a cost of $2,694.09 and resulted in 21.95 quality-adjusted life years (QALYs). 13C-Urea Breath Test screening had a cost of $2,105.28 and led to 22.37 QALYs. Stool antigen testing had a cost of $2,126.00 and yielded 22.30 QALYs.
In the no-screening group, an estimated 2.04% of patients would develop gastric cancer, and 1.82% would die of it. With screening, the frequency of gastric cancer dropped to 1.59%-1.65%, with a gastric cancer mortality rate of 1.41%-1.46%. Overall, screening was modeled to lead to a 19.1%-22.0% risk reduction.
The researchers validated their model by an assumption of an H. pylori infection rate of 100% and then compared the results of the model to the outcome of the study by Dr. Choi and colleagues. In the trial, there was a 55% reduction in gastric cancer among treated patients at a median of 9 years of follow-up. Those who had successful eradication of H. pylori had a 73% reduction. The new model estimated reductions from a testing and treatment strategy of 53.3%-64.5%.
The findings aren’t surprising, according to Joseph Jennings, MD, of the department of medicine at Georgetown University, Washington, and director of the Center for GI Bleeding at MedStar Georgetown University Hospital, who was not involved with the study. “Even eliminating one person getting gastric cancer, where they will then need major surgery, chemotherapy, all these very expensive interventions [is important],” said Dr. Jennings. “We have very efficient ways to test for these things that don’t involve endoscopy.”
One potential caveat to identifying and treating H. pylori infection is whether elimination of H. pylori may lead to some adverse effects. Some patients can experience increased acid reflux as a result, while others suffer no ill effects. “But when you’re dealing with the alternative, which is stomach cancer, those negatives would have to stack up really, really high to outweigh the positives of preventing a cancer that’s really hard to treat,” said Dr. Jennings.
Dr. Jennings pointed out that the model also projected testing and an intervention conducted in a South Korean population, and extrapolated it to a U.S. population, where the incidence of gastric cancer is lower. “There definitely are some questions about how well it would translate if applied to the general United States population,” said Dr. Jennings.
That question could prompt researchers to conduct a U.S.-based study modeled after the test and treat study in South Korea to see if the regimen produced similar results. The model should add weight to that argument, said Dr. Jennings: “This is raising the point that, at least from an intellectual level, it might be worth now designing the study to see if it works in our population,” said Dr. Jennings.
The authors and Dr. Jennings have no relevant financial disclosures.
FROM GASTROENTEROLOGY
Buprenorphine offers a way to rise from the ashes of addiction
One of the most rewarding aspects of being a physician is having a direct impact on alleviating patient suffering. On the other hand, one of the more difficult elements is a confrontational patient with unreasonable expectations or inappropriate demands. I have experienced both ends of the spectrum while engaging with patients who have opioid use disorder (OUD).
An untreated patient with OUD might provide an untruthful history, attempt to falsify exam findings, or even become threatening or abusive in an attempt to secure opiate pain medication. Managing a patient with OUD by providing buprenorphine treatment, however, is a completely different experience.
There is no controversy about the effectiveness of buprenorphine treatment for OUD. Patients seeking it are not looking for inappropriate care but rather a treatment that is established as an unequivocal standard with proven results for better treatment outcomes1-3 and reduced mortality.4 Personally, I’ve found offering buprenorphine treatment to be one of the most rewarding aspects of practicing medicine. It is a real joy to witness people turn their lives around with meaningful outcomes such as gainful employment, eradication of hepatitis C, reconciliation of broken relationships, resolution of legal troubles, and long-term sobriety. Being a part of lives that are practically resurrected from the ashes of addiction by prescribing medicine is indeed an exceptional experience.
On April 28, 2021, the Department of Health and Human Services provided notice for immediate action allowing for any DEA-licensed provider to obtain an X-waiver to treat 30 active patients without educational prerequisite or certification of behavioral health referral capacity.5 The X-waiver requirements were reduced, as outlined by SAMSHA,6 to a simple online notice of intent7 that can be completed in less than 5 minutes.
I encourage my colleagues to obtain the X-waiver by the simplified process, start prescribing buprenorphine, and be a part of the solution to the opioid epidemic. Of course, there will be struggles and lessons learned, but these can most certainly be eclipsed by a focus on the rewarding experience of restoring wholeness to the lives of many patients.
Aaron Newcomb, DO
Carbondale, IL
1. Norton BL, Beitin A, Glenn M, et al. Retention in buprenorphine treatment is associated with improved HCV care outcomes. J Subst Abuse Treat. 2017;75:38-42. doi: 10.1016/j.jsat.2017.01.015
2. Evans EA, Zhu Y, Yoo C, et al. Criminal justice outcomes over 5 years after randomization to buprenorphine-naloxone or methadone treatment for opioid use disorder. Addiction. 2019;114:1396-1404. doi: 10.1111/add.14620
3. Mattick RP, Breen C, Kimber J, et al. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane. Published February 6, 2014. Accessed August 10, 2021. www.cochrane.org/CD002207/ADDICTN_buprenorphine-maintenance-versus-placebo-or-methadone-maintenance-for-opioid-dependence
4. Methadone and buprenorphine reduce risk of death after opioid overdose. National Institutes of Health. Published June 19, 2018. Accessed August 10, 2021. www.nih.gov/news-events/news-releases/methadone-buprenorphine-reduce-risk-death-after-opioid-overdose
5. Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. Department of Health and Human Services; 2021. Accessed August 10, 2021. www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder
6. US Department of Health & Human Services. Become a buprenorphine waivered practitioner. SAMHSA. Updated May 14, 2021. Accessed August 10, 2021. www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner
7. Buprenorphine waiver notification. SAMHSA. Accessed August 10, 2021. https://buprenorphine.samhsa.gov/forms/select-practitioner-type.php
One of the most rewarding aspects of being a physician is having a direct impact on alleviating patient suffering. On the other hand, one of the more difficult elements is a confrontational patient with unreasonable expectations or inappropriate demands. I have experienced both ends of the spectrum while engaging with patients who have opioid use disorder (OUD).
An untreated patient with OUD might provide an untruthful history, attempt to falsify exam findings, or even become threatening or abusive in an attempt to secure opiate pain medication. Managing a patient with OUD by providing buprenorphine treatment, however, is a completely different experience.
There is no controversy about the effectiveness of buprenorphine treatment for OUD. Patients seeking it are not looking for inappropriate care but rather a treatment that is established as an unequivocal standard with proven results for better treatment outcomes1-3 and reduced mortality.4 Personally, I’ve found offering buprenorphine treatment to be one of the most rewarding aspects of practicing medicine. It is a real joy to witness people turn their lives around with meaningful outcomes such as gainful employment, eradication of hepatitis C, reconciliation of broken relationships, resolution of legal troubles, and long-term sobriety. Being a part of lives that are practically resurrected from the ashes of addiction by prescribing medicine is indeed an exceptional experience.
On April 28, 2021, the Department of Health and Human Services provided notice for immediate action allowing for any DEA-licensed provider to obtain an X-waiver to treat 30 active patients without educational prerequisite or certification of behavioral health referral capacity.5 The X-waiver requirements were reduced, as outlined by SAMSHA,6 to a simple online notice of intent7 that can be completed in less than 5 minutes.
I encourage my colleagues to obtain the X-waiver by the simplified process, start prescribing buprenorphine, and be a part of the solution to the opioid epidemic. Of course, there will be struggles and lessons learned, but these can most certainly be eclipsed by a focus on the rewarding experience of restoring wholeness to the lives of many patients.
Aaron Newcomb, DO
Carbondale, IL
One of the most rewarding aspects of being a physician is having a direct impact on alleviating patient suffering. On the other hand, one of the more difficult elements is a confrontational patient with unreasonable expectations or inappropriate demands. I have experienced both ends of the spectrum while engaging with patients who have opioid use disorder (OUD).
An untreated patient with OUD might provide an untruthful history, attempt to falsify exam findings, or even become threatening or abusive in an attempt to secure opiate pain medication. Managing a patient with OUD by providing buprenorphine treatment, however, is a completely different experience.
There is no controversy about the effectiveness of buprenorphine treatment for OUD. Patients seeking it are not looking for inappropriate care but rather a treatment that is established as an unequivocal standard with proven results for better treatment outcomes1-3 and reduced mortality.4 Personally, I’ve found offering buprenorphine treatment to be one of the most rewarding aspects of practicing medicine. It is a real joy to witness people turn their lives around with meaningful outcomes such as gainful employment, eradication of hepatitis C, reconciliation of broken relationships, resolution of legal troubles, and long-term sobriety. Being a part of lives that are practically resurrected from the ashes of addiction by prescribing medicine is indeed an exceptional experience.
On April 28, 2021, the Department of Health and Human Services provided notice for immediate action allowing for any DEA-licensed provider to obtain an X-waiver to treat 30 active patients without educational prerequisite or certification of behavioral health referral capacity.5 The X-waiver requirements were reduced, as outlined by SAMSHA,6 to a simple online notice of intent7 that can be completed in less than 5 minutes.
I encourage my colleagues to obtain the X-waiver by the simplified process, start prescribing buprenorphine, and be a part of the solution to the opioid epidemic. Of course, there will be struggles and lessons learned, but these can most certainly be eclipsed by a focus on the rewarding experience of restoring wholeness to the lives of many patients.
Aaron Newcomb, DO
Carbondale, IL
1. Norton BL, Beitin A, Glenn M, et al. Retention in buprenorphine treatment is associated with improved HCV care outcomes. J Subst Abuse Treat. 2017;75:38-42. doi: 10.1016/j.jsat.2017.01.015
2. Evans EA, Zhu Y, Yoo C, et al. Criminal justice outcomes over 5 years after randomization to buprenorphine-naloxone or methadone treatment for opioid use disorder. Addiction. 2019;114:1396-1404. doi: 10.1111/add.14620
3. Mattick RP, Breen C, Kimber J, et al. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane. Published February 6, 2014. Accessed August 10, 2021. www.cochrane.org/CD002207/ADDICTN_buprenorphine-maintenance-versus-placebo-or-methadone-maintenance-for-opioid-dependence
4. Methadone and buprenorphine reduce risk of death after opioid overdose. National Institutes of Health. Published June 19, 2018. Accessed August 10, 2021. www.nih.gov/news-events/news-releases/methadone-buprenorphine-reduce-risk-death-after-opioid-overdose
5. Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. Department of Health and Human Services; 2021. Accessed August 10, 2021. www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder
6. US Department of Health & Human Services. Become a buprenorphine waivered practitioner. SAMHSA. Updated May 14, 2021. Accessed August 10, 2021. www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner
7. Buprenorphine waiver notification. SAMHSA. Accessed August 10, 2021. https://buprenorphine.samhsa.gov/forms/select-practitioner-type.php
1. Norton BL, Beitin A, Glenn M, et al. Retention in buprenorphine treatment is associated with improved HCV care outcomes. J Subst Abuse Treat. 2017;75:38-42. doi: 10.1016/j.jsat.2017.01.015
2. Evans EA, Zhu Y, Yoo C, et al. Criminal justice outcomes over 5 years after randomization to buprenorphine-naloxone or methadone treatment for opioid use disorder. Addiction. 2019;114:1396-1404. doi: 10.1111/add.14620
3. Mattick RP, Breen C, Kimber J, et al. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane. Published February 6, 2014. Accessed August 10, 2021. www.cochrane.org/CD002207/ADDICTN_buprenorphine-maintenance-versus-placebo-or-methadone-maintenance-for-opioid-dependence
4. Methadone and buprenorphine reduce risk of death after opioid overdose. National Institutes of Health. Published June 19, 2018. Accessed August 10, 2021. www.nih.gov/news-events/news-releases/methadone-buprenorphine-reduce-risk-death-after-opioid-overdose
5. Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. Department of Health and Human Services; 2021. Accessed August 10, 2021. www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder
6. US Department of Health & Human Services. Become a buprenorphine waivered practitioner. SAMHSA. Updated May 14, 2021. Accessed August 10, 2021. www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner
7. Buprenorphine waiver notification. SAMHSA. Accessed August 10, 2021. https://buprenorphine.samhsa.gov/forms/select-practitioner-type.php
Successful Recruitment of VA Patients in Precision Medicine Research Through Passive Recruitment Efforts
Background
We sought to evaluate passive recruitment efforts of VA patients into a precision medicine research program. Access to clinical trials and other research opportunities is important to discovering new disease treatments and better ways to detect, diagnose, and reduce disease risk. The WISDOM (Women Informed to Screen Depending on Measures of risk) Study is a multi-site, pragmatic trial with webbased participation based at the University of California at San Francisco (UCSF) that aims to move breast cancer screening away from its current one-size-fitsall approach to one that is personalized based on each woman’s individual risk.
Methods
We created a hub and spoke recruitment model with the San Francisco VA Medical Center (SFVAMC) serving as the central hub of passive recruitment activities and eligible VA facilities that agreed to participate serving as the spoke recruitment sites. Eligible facilities had at least 3,000 women patients, VA clinical genetic services available, a site lead from the VA Women’s Health-Practice-Based Research Network, and mammography on site. Site participation involved permission for the research team to email eligible patients (women aged 40-74 without prior breast cancer diagnosis) about the WISDOM Study. We evaluated the effectiveness of the recruitment by assessing trends in enrollment and monitoring participation of VA patients in the WISDOM Study. Analysis: Pre/post frequencies of women consenting to participate in the WISDOM Study.
Results
From 5/24/2021 through 6/21/2021, we emailed 27,061 eligible VA patients from six participating VA facilities. Prior to the VA emailing, an average of 22 women per week consented to participating in the WISDOM Study and none were Veterans. After the first month of the VA emailing, an average of 186 women per week consented – a 7.5-fold increase. Additionally, during the first month of VA emailing, 81% of women registering with the WISDOM Study said they heard about the study from the VA.
Implications
The VA has recently approved of emailing as a method for recruiting research subjects. Our results demonstrate this is a feasible approach for precision medicine research, a growing area of research in VA and at academic affiliates.
Background
We sought to evaluate passive recruitment efforts of VA patients into a precision medicine research program. Access to clinical trials and other research opportunities is important to discovering new disease treatments and better ways to detect, diagnose, and reduce disease risk. The WISDOM (Women Informed to Screen Depending on Measures of risk) Study is a multi-site, pragmatic trial with webbased participation based at the University of California at San Francisco (UCSF) that aims to move breast cancer screening away from its current one-size-fitsall approach to one that is personalized based on each woman’s individual risk.
Methods
We created a hub and spoke recruitment model with the San Francisco VA Medical Center (SFVAMC) serving as the central hub of passive recruitment activities and eligible VA facilities that agreed to participate serving as the spoke recruitment sites. Eligible facilities had at least 3,000 women patients, VA clinical genetic services available, a site lead from the VA Women’s Health-Practice-Based Research Network, and mammography on site. Site participation involved permission for the research team to email eligible patients (women aged 40-74 without prior breast cancer diagnosis) about the WISDOM Study. We evaluated the effectiveness of the recruitment by assessing trends in enrollment and monitoring participation of VA patients in the WISDOM Study. Analysis: Pre/post frequencies of women consenting to participate in the WISDOM Study.
Results
From 5/24/2021 through 6/21/2021, we emailed 27,061 eligible VA patients from six participating VA facilities. Prior to the VA emailing, an average of 22 women per week consented to participating in the WISDOM Study and none were Veterans. After the first month of the VA emailing, an average of 186 women per week consented – a 7.5-fold increase. Additionally, during the first month of VA emailing, 81% of women registering with the WISDOM Study said they heard about the study from the VA.
Implications
The VA has recently approved of emailing as a method for recruiting research subjects. Our results demonstrate this is a feasible approach for precision medicine research, a growing area of research in VA and at academic affiliates.
Background
We sought to evaluate passive recruitment efforts of VA patients into a precision medicine research program. Access to clinical trials and other research opportunities is important to discovering new disease treatments and better ways to detect, diagnose, and reduce disease risk. The WISDOM (Women Informed to Screen Depending on Measures of risk) Study is a multi-site, pragmatic trial with webbased participation based at the University of California at San Francisco (UCSF) that aims to move breast cancer screening away from its current one-size-fitsall approach to one that is personalized based on each woman’s individual risk.
Methods
We created a hub and spoke recruitment model with the San Francisco VA Medical Center (SFVAMC) serving as the central hub of passive recruitment activities and eligible VA facilities that agreed to participate serving as the spoke recruitment sites. Eligible facilities had at least 3,000 women patients, VA clinical genetic services available, a site lead from the VA Women’s Health-Practice-Based Research Network, and mammography on site. Site participation involved permission for the research team to email eligible patients (women aged 40-74 without prior breast cancer diagnosis) about the WISDOM Study. We evaluated the effectiveness of the recruitment by assessing trends in enrollment and monitoring participation of VA patients in the WISDOM Study. Analysis: Pre/post frequencies of women consenting to participate in the WISDOM Study.
Results
From 5/24/2021 through 6/21/2021, we emailed 27,061 eligible VA patients from six participating VA facilities. Prior to the VA emailing, an average of 22 women per week consented to participating in the WISDOM Study and none were Veterans. After the first month of the VA emailing, an average of 186 women per week consented – a 7.5-fold increase. Additionally, during the first month of VA emailing, 81% of women registering with the WISDOM Study said they heard about the study from the VA.
Implications
The VA has recently approved of emailing as a method for recruiting research subjects. Our results demonstrate this is a feasible approach for precision medicine research, a growing area of research in VA and at academic affiliates.