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Brexanolone approval ‘marks an important milestone’
In March 2019, the Food and Drug Administration approved a novel medication, Zulresso (brexanolone), for the treatment of postpartum depression. Brexanolone is the first FDA-approved medication for the treatment of postpartum depression, a serious illness that affects nearly one in nine women soon after giving birth.1
Mothers with postpartum depression experience feelings of sadness, irritability, and anxiety, as well as isolation from their loved ones (including their new baby) and exhaustion. The feelings of sadness and anxiety can be extreme, and can interfere with a woman’s ability to care for herself or her family. In some cases, these symptoms can be life threatening. Indeed, the most common cause of maternal death after childbirth in the developed world is suicide.2 Because of the severity of the symptoms and their impact on the family, postpartum depression usually requires treatment.
Until now, there have been no drugs specifically approved to treat postpartum depression. Commonly, postpartum depression is treated with medications that previously were approved for the treatment of major depressive disorder, despite limited evidence documenting their efficacy for postpartum depression. Other putative treatment alternatives include psychotherapy, estrogen therapy, and neuromodulation, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation. Each of these treatments can take weeks or longer to take effect, time that is of elevated importance given the rapidly developing mother-infant relationship in the early postpartum period. Brexanolone addresses both the issue of efficacy and speed of onset, representing a major step forward in the care of women suffering from postpartum depression.
Importantly, the approval of brexanolone marks an important milestone for the psychiatric research community in general and the National Institute of Mental Health in particular, as it represents a compelling example of successful bench-to-bedside translation of basic neuroscience findings to benefit patients. As we have noted elsewhere,3 the research underlying the discovery of endogenous neurosteroids and their role in modulating GABA receptors laid the foundation for the development of brexanolone, an intravenous formulation of the neurosteroid allopregnanolone. The recognition that allopregnanolone was a protective factor induced by stress, that it derived from progesterone, and that its peripheral blood levels were dramatically reduced in the early postpartum period led to the hypothesis that it might be useful as a treatment for postpartum depression.
Sage Therapeutics took on the task of testing this hypothesis, designing a program, in consultation with the FDA, to test the efficacy of allopregnanolone in women with postpartum depression in a series of randomized, placebo-controlled studies assessing brexanolone. 4,5 It is a significant accomplishment of Sage Therapeutics to not only successfully complete the therapeutic program of studies (given past experience with difficulties recruiting these women for placebo-controlled treatment trials) but as well to demonstrate a robust therapeutic effect.
Although the FDA’s approval of a new and novel treatment is exciting for many women, there are still limitations to the broader use of brexanolone. It is delivered intravenously, requires an overnight stay in a certified medical center, and is likely to be considerably expensive, according to early reports – potentially limiting the access to the treatment. There also are potentially serious side effects, such as sedation, dizziness, or sudden loss of consciousness. Nonetheless, this is a promising first step and hopefully will spur further efforts to identify and optimize additional strategies to treat postpartum depression. In fact, other formulations of allopregnanolone and novel analogs to treat postpartum depression already are under study, including some that are orally bioavailable.6,7,8
Several important questions remain to be answered about both brexanolone and postpartum depression: What is the underlying mechanism through which allopregnanolone acts in the brain and reduces depressive symptoms? Is the mechanism unique to postpartum women, or might brexanolone also be effective in nonreproductive depressions in women and men? What causes postpartum depression, and what are the risk factors involved for women who develop this serious condition? Future work will focus on these and other important questions to the benefit of women who have suffered with this condition.
The FDA approval of brexanolone represents the second approval in a month of a new antidepressant treatment targeting different molecules in the brain. In early March 2019, the agency approved Spravato (esketamine) nasal spray as a therapy for treatment-resistant depression. Like brexanolone, esketamine is a fast-acting antidepressant that works through a novel mechanism, completely different from other antidepressants. These new treatment approvals are encouraging, as there has been a paucity for many years in approving new effective treatments for mood disorders.
However, treatment development in psychiatry still has a long way to go and the full underlying neurobiology of mood disorders, including postpartum depression, remains poorly understood. Many challenges are ahead of us in our efforts to develop new treatments and increase our understanding of mental illnesses. Nevertheless, the approval of brexanolone is an important milestone, giving hope to the many women who suffer from postpartum depression, and paving the way for the development of additional novel and effective medications to treat this serious and sometimes life-threatening condition.
Dr. Gordon is the director of the National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders. He oversees an extensive research portfolio of basic and clinical research that seeks to transform the understanding and treatment of mental illnesses, paving the way for prevention, recovery, and cure. Dr. Hillefors works at the NIMH and oversees the Translational Therapeutics Program in the division of translational research, focusing on the development of novel treatments and biomarkers and early phase clinical trials. She received her MD and PhD in neuroscience at the Karolinska Institute, Sweden. Dr. Schmidt joined the NIMH in 1986 after completing his psychiatric residency at the University of Toronto. He is the chief of the Section on Behavioral Endocrinology, within the Intramural Research Program at the NIMH, where his laboratory studies the relationship between hormones, stress, and mood – particularly in the areas of postpartum depression, severe premenstrual dysphoria, and perimenopausal depression.
References
1. J Psychiatric Res. 2018 Sep;104:235-48.
2. Br J Psychiatry. 2003 Oct;183:279-81.
3. NIMH Director’s Messages. 2019 Mar 20.
4. Lancet. 2017 Jul 29;390(10093):480-9.
5. Lancet. 2018 Sep 22; 392(10152):1058-70.
6. Sage Therapeutics News. 2019 Jan 7.
7. Marinus Pharmaceuticals. 2017 Jun 27.
8. ClinicalTrials.gov Identifier: NCT03460756. 2019 Mar.
In March 2019, the Food and Drug Administration approved a novel medication, Zulresso (brexanolone), for the treatment of postpartum depression. Brexanolone is the first FDA-approved medication for the treatment of postpartum depression, a serious illness that affects nearly one in nine women soon after giving birth.1
Mothers with postpartum depression experience feelings of sadness, irritability, and anxiety, as well as isolation from their loved ones (including their new baby) and exhaustion. The feelings of sadness and anxiety can be extreme, and can interfere with a woman’s ability to care for herself or her family. In some cases, these symptoms can be life threatening. Indeed, the most common cause of maternal death after childbirth in the developed world is suicide.2 Because of the severity of the symptoms and their impact on the family, postpartum depression usually requires treatment.
Until now, there have been no drugs specifically approved to treat postpartum depression. Commonly, postpartum depression is treated with medications that previously were approved for the treatment of major depressive disorder, despite limited evidence documenting their efficacy for postpartum depression. Other putative treatment alternatives include psychotherapy, estrogen therapy, and neuromodulation, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation. Each of these treatments can take weeks or longer to take effect, time that is of elevated importance given the rapidly developing mother-infant relationship in the early postpartum period. Brexanolone addresses both the issue of efficacy and speed of onset, representing a major step forward in the care of women suffering from postpartum depression.
Importantly, the approval of brexanolone marks an important milestone for the psychiatric research community in general and the National Institute of Mental Health in particular, as it represents a compelling example of successful bench-to-bedside translation of basic neuroscience findings to benefit patients. As we have noted elsewhere,3 the research underlying the discovery of endogenous neurosteroids and their role in modulating GABA receptors laid the foundation for the development of brexanolone, an intravenous formulation of the neurosteroid allopregnanolone. The recognition that allopregnanolone was a protective factor induced by stress, that it derived from progesterone, and that its peripheral blood levels were dramatically reduced in the early postpartum period led to the hypothesis that it might be useful as a treatment for postpartum depression.
Sage Therapeutics took on the task of testing this hypothesis, designing a program, in consultation with the FDA, to test the efficacy of allopregnanolone in women with postpartum depression in a series of randomized, placebo-controlled studies assessing brexanolone. 4,5 It is a significant accomplishment of Sage Therapeutics to not only successfully complete the therapeutic program of studies (given past experience with difficulties recruiting these women for placebo-controlled treatment trials) but as well to demonstrate a robust therapeutic effect.
Although the FDA’s approval of a new and novel treatment is exciting for many women, there are still limitations to the broader use of brexanolone. It is delivered intravenously, requires an overnight stay in a certified medical center, and is likely to be considerably expensive, according to early reports – potentially limiting the access to the treatment. There also are potentially serious side effects, such as sedation, dizziness, or sudden loss of consciousness. Nonetheless, this is a promising first step and hopefully will spur further efforts to identify and optimize additional strategies to treat postpartum depression. In fact, other formulations of allopregnanolone and novel analogs to treat postpartum depression already are under study, including some that are orally bioavailable.6,7,8
Several important questions remain to be answered about both brexanolone and postpartum depression: What is the underlying mechanism through which allopregnanolone acts in the brain and reduces depressive symptoms? Is the mechanism unique to postpartum women, or might brexanolone also be effective in nonreproductive depressions in women and men? What causes postpartum depression, and what are the risk factors involved for women who develop this serious condition? Future work will focus on these and other important questions to the benefit of women who have suffered with this condition.
The FDA approval of brexanolone represents the second approval in a month of a new antidepressant treatment targeting different molecules in the brain. In early March 2019, the agency approved Spravato (esketamine) nasal spray as a therapy for treatment-resistant depression. Like brexanolone, esketamine is a fast-acting antidepressant that works through a novel mechanism, completely different from other antidepressants. These new treatment approvals are encouraging, as there has been a paucity for many years in approving new effective treatments for mood disorders.
However, treatment development in psychiatry still has a long way to go and the full underlying neurobiology of mood disorders, including postpartum depression, remains poorly understood. Many challenges are ahead of us in our efforts to develop new treatments and increase our understanding of mental illnesses. Nevertheless, the approval of brexanolone is an important milestone, giving hope to the many women who suffer from postpartum depression, and paving the way for the development of additional novel and effective medications to treat this serious and sometimes life-threatening condition.
Dr. Gordon is the director of the National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders. He oversees an extensive research portfolio of basic and clinical research that seeks to transform the understanding and treatment of mental illnesses, paving the way for prevention, recovery, and cure. Dr. Hillefors works at the NIMH and oversees the Translational Therapeutics Program in the division of translational research, focusing on the development of novel treatments and biomarkers and early phase clinical trials. She received her MD and PhD in neuroscience at the Karolinska Institute, Sweden. Dr. Schmidt joined the NIMH in 1986 after completing his psychiatric residency at the University of Toronto. He is the chief of the Section on Behavioral Endocrinology, within the Intramural Research Program at the NIMH, where his laboratory studies the relationship between hormones, stress, and mood – particularly in the areas of postpartum depression, severe premenstrual dysphoria, and perimenopausal depression.
References
1. J Psychiatric Res. 2018 Sep;104:235-48.
2. Br J Psychiatry. 2003 Oct;183:279-81.
3. NIMH Director’s Messages. 2019 Mar 20.
4. Lancet. 2017 Jul 29;390(10093):480-9.
5. Lancet. 2018 Sep 22; 392(10152):1058-70.
6. Sage Therapeutics News. 2019 Jan 7.
7. Marinus Pharmaceuticals. 2017 Jun 27.
8. ClinicalTrials.gov Identifier: NCT03460756. 2019 Mar.
In March 2019, the Food and Drug Administration approved a novel medication, Zulresso (brexanolone), for the treatment of postpartum depression. Brexanolone is the first FDA-approved medication for the treatment of postpartum depression, a serious illness that affects nearly one in nine women soon after giving birth.1
Mothers with postpartum depression experience feelings of sadness, irritability, and anxiety, as well as isolation from their loved ones (including their new baby) and exhaustion. The feelings of sadness and anxiety can be extreme, and can interfere with a woman’s ability to care for herself or her family. In some cases, these symptoms can be life threatening. Indeed, the most common cause of maternal death after childbirth in the developed world is suicide.2 Because of the severity of the symptoms and their impact on the family, postpartum depression usually requires treatment.
Until now, there have been no drugs specifically approved to treat postpartum depression. Commonly, postpartum depression is treated with medications that previously were approved for the treatment of major depressive disorder, despite limited evidence documenting their efficacy for postpartum depression. Other putative treatment alternatives include psychotherapy, estrogen therapy, and neuromodulation, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation. Each of these treatments can take weeks or longer to take effect, time that is of elevated importance given the rapidly developing mother-infant relationship in the early postpartum period. Brexanolone addresses both the issue of efficacy and speed of onset, representing a major step forward in the care of women suffering from postpartum depression.
Importantly, the approval of brexanolone marks an important milestone for the psychiatric research community in general and the National Institute of Mental Health in particular, as it represents a compelling example of successful bench-to-bedside translation of basic neuroscience findings to benefit patients. As we have noted elsewhere,3 the research underlying the discovery of endogenous neurosteroids and their role in modulating GABA receptors laid the foundation for the development of brexanolone, an intravenous formulation of the neurosteroid allopregnanolone. The recognition that allopregnanolone was a protective factor induced by stress, that it derived from progesterone, and that its peripheral blood levels were dramatically reduced in the early postpartum period led to the hypothesis that it might be useful as a treatment for postpartum depression.
Sage Therapeutics took on the task of testing this hypothesis, designing a program, in consultation with the FDA, to test the efficacy of allopregnanolone in women with postpartum depression in a series of randomized, placebo-controlled studies assessing brexanolone. 4,5 It is a significant accomplishment of Sage Therapeutics to not only successfully complete the therapeutic program of studies (given past experience with difficulties recruiting these women for placebo-controlled treatment trials) but as well to demonstrate a robust therapeutic effect.
Although the FDA’s approval of a new and novel treatment is exciting for many women, there are still limitations to the broader use of brexanolone. It is delivered intravenously, requires an overnight stay in a certified medical center, and is likely to be considerably expensive, according to early reports – potentially limiting the access to the treatment. There also are potentially serious side effects, such as sedation, dizziness, or sudden loss of consciousness. Nonetheless, this is a promising first step and hopefully will spur further efforts to identify and optimize additional strategies to treat postpartum depression. In fact, other formulations of allopregnanolone and novel analogs to treat postpartum depression already are under study, including some that are orally bioavailable.6,7,8
Several important questions remain to be answered about both brexanolone and postpartum depression: What is the underlying mechanism through which allopregnanolone acts in the brain and reduces depressive symptoms? Is the mechanism unique to postpartum women, or might brexanolone also be effective in nonreproductive depressions in women and men? What causes postpartum depression, and what are the risk factors involved for women who develop this serious condition? Future work will focus on these and other important questions to the benefit of women who have suffered with this condition.
The FDA approval of brexanolone represents the second approval in a month of a new antidepressant treatment targeting different molecules in the brain. In early March 2019, the agency approved Spravato (esketamine) nasal spray as a therapy for treatment-resistant depression. Like brexanolone, esketamine is a fast-acting antidepressant that works through a novel mechanism, completely different from other antidepressants. These new treatment approvals are encouraging, as there has been a paucity for many years in approving new effective treatments for mood disorders.
However, treatment development in psychiatry still has a long way to go and the full underlying neurobiology of mood disorders, including postpartum depression, remains poorly understood. Many challenges are ahead of us in our efforts to develop new treatments and increase our understanding of mental illnesses. Nevertheless, the approval of brexanolone is an important milestone, giving hope to the many women who suffer from postpartum depression, and paving the way for the development of additional novel and effective medications to treat this serious and sometimes life-threatening condition.
Dr. Gordon is the director of the National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders. He oversees an extensive research portfolio of basic and clinical research that seeks to transform the understanding and treatment of mental illnesses, paving the way for prevention, recovery, and cure. Dr. Hillefors works at the NIMH and oversees the Translational Therapeutics Program in the division of translational research, focusing on the development of novel treatments and biomarkers and early phase clinical trials. She received her MD and PhD in neuroscience at the Karolinska Institute, Sweden. Dr. Schmidt joined the NIMH in 1986 after completing his psychiatric residency at the University of Toronto. He is the chief of the Section on Behavioral Endocrinology, within the Intramural Research Program at the NIMH, where his laboratory studies the relationship between hormones, stress, and mood – particularly in the areas of postpartum depression, severe premenstrual dysphoria, and perimenopausal depression.
References
1. J Psychiatric Res. 2018 Sep;104:235-48.
2. Br J Psychiatry. 2003 Oct;183:279-81.
3. NIMH Director’s Messages. 2019 Mar 20.
4. Lancet. 2017 Jul 29;390(10093):480-9.
5. Lancet. 2018 Sep 22; 392(10152):1058-70.
6. Sage Therapeutics News. 2019 Jan 7.
7. Marinus Pharmaceuticals. 2017 Jun 27.
8. ClinicalTrials.gov Identifier: NCT03460756. 2019 Mar.
Use of GBCA in MRIs for High-Risk Patients
To the Editor:
We read with interest the case report of nephrogenic systemic fibrosis (NSF) by Chuang, Kaneshiro, and Betancourt in the June 2018 issue of Federal Practitioner.1 It was reported that a 61-year-old Hispanic male patient with a history of IV heroin abuse with end-stage renal disease (ESRD) secondary to membranous glomerulonephritis on hemodialysis and chronic hepatitis C infection received 15 mL gadoversetamide, a linear gadolinium-based contrast agent (GBCA) during magnetic resonance imaging (MRI) of the brain. Hemodialysis was performed 18 hours after the contrast administration.
Eight weeks after his initial presentation, the patient developed pyoderma gangrenosum on his right forearm, which was treated with high-dose steroids. He then developed thickening and induration of his bilateral forearm skin with peau d’orange appearance. NSF was confirmed by a skin biopsy. The patient developed contractures of his upper and lower extremities and was finally wheelchair bound.
This case is very concerning since no NSF cases in patients receiving GBCA have been published since 2009. Unfortunately, the authors give no information on the occurrence of this particular case. Thus, it is unclear whether this case was observed before or after the switch to macrocyclic agents in patients with reduced renal function. The reported patient with ESRD was on hemodialysis and received 15 mL gadoversetamide during MRI of the brain. In 2007 the ESUR (European Society of Urogenital Radiology) published guidelines indicating linear GBCA (gadodiamide, gadoversetamide, gadopentetate dimeglumine) as high-risk agents that may not be used in patients with eGFR < 30 mL/min/1.73 m2.2,3
Consequently in 2007, the European Medicines Agency contraindicated these linear GBCA in patients with chronic kidney disease grades 4 and 5. Also in 2007 the US Food and Drug Administration (FDA) requested a revision of the prescribing information for all 5 GBCA approved in the US.4 In response to accumulating more informative data, in 2010 the FDA again used this class labeling approach to more explicitly describe differences in NSF risks among the agents.4 FDA regulation and contraindication of the use of low-stability GBCA in patients with advanced renal impairment and robust local policies on the safe use of these agents have resulted in marked reduction in the prevalence of NSF in the US. This case report needs to clarify why a high-risk linear agent was administered to a patient with ESRD.
In 2006 Grobner and Marckmann and colleagues reported their observations of a previously unrecognized link between exposure to gadodiamide and the development of NSF.5,6 It soon became clear that NSF is a delayed adverse contrast reaction that may cause severe disability and even death. Advanced renal disease and high-risk linear GBCA are the main factors in the pathogenesis of NSF. Additionally, the dose of the agent may play a role. NSF can occur from hours to years after exposure to GBCA. Not all patients with severe kidney disease exposed to high-risk agents developed NSF. Thus, additional factors were proposed to play a role in the pathogenesis of NSF. Among those factors were erythropoietin, metabolic acidosis, anion gap, iron, increased phosphate, zinc loss, proinflammatory conditions/inflammation and angiotensin-converting enzyme (ACE) inhibitors.7 Although there is little proof with these assumptions, special care must be taken as shown by this reported patient with multiple inflammatory disorders.
- Gertraud Heinz, MD, MBA; Aart van der Molen, MD; and Giles Roditi, MD; on behalf of the ESUR Contrast Media Safety Committee
Author affiliations: Gertraud Heinz is former President ESUR and Head of the Department of Radiology, Diagnostics and Intervention University Hospital St. Pölten Karl Landsteiner University of Health Sciences.
Correspondence: Gertraud Heinz (gertraud.heinz@stpoelten .lknoe.at)
Disclosures: The authors report no conflict of interest with regard to this article.
References
1. Chuang K, Kaneshiro C, Betancourt J. Nephrogenic systemic fibrosis in a patient with multiple inflammatory disorders. Fed Pract. 2018;35(6):40-43.
2. Thomsen HS; European Society of Urogenital Radiology (ESUR). ESUR guideline: gadolinium based contrast media and nephrogenic systemic fibrosis. Eur Radiol. 2007;17(10):2692-2696.
3. Thomsen HS, Morcos SK, Almén T, et al; ESUR Contrast Medium Safety Committee. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Media Safety Committee guidelines. Eur Radiol. 2013;23(2):307-318
4. Yang L, Krefting I, Gorovets A, et al. Nephrogenic systemic fibrosis and class labeling of gadolinium-based agents by the Food and Drug Administration. Radiology. 2012;265(1):248-253.
5. Grobner T. Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006;21(4):1104-1108.
6. Marckmann P, Skov L, Rossen K, et al. Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol. 2006;17(9):2359-2362.
7. Thomsen HS, Bennett CL. Six years after. Acta Radiol. 2012;53(8):827-829.
To the Editor:
With great interest, I read the case report by Chuang, Kaneshiro, and Betancourt.1 Patients with nephrogenic systemic fibrosis (NSF) are of special interest because the disease is still unclear as mentioned by the authors. Although new cases may occur,2 this case raises some concerns that I would like to address.
First, it would be of great interest to know the date when the patient received the high-risk gadolinium-based contrast agent (GBCA) gadoversetamide. Unfortunately, the authors did not mention the date of the injection of the GBCA that probably caused NSF. Due to the obvious association between the applications of special GBCAs in 2006, the US Food and Drug Administration (FDA) warned physicians not to inject these contrast agents in patients with compromised kidney function.3 Moreover, in 2007 the American College of Radiology (ACR) published guidelines for the safe use of GBCAs in patients with renal failure.4 Also, the European Medicines Agency (EMA) demanded that companies provide warning in product inserts about the acquisition of NSF in patients with severe kidney injury.5
Second, the clinical illustration of the case is inadequate. In the manuscript, we read that the patient acquired NSF-characteristic lesions like peau d’orange skin lesions and contractures of his extremities, but unfortunately, Chuang, Kaneshiro, and Betancourt did not provide figures that show them. On the other hand, Figure 1 shows an uncharacteristic dermal induration around inflammatory and ulcerated skin lesion (pyoderma gangrenosum).1 Such clinical signs are well known and occur perilesional of different conditions independently of NSF.6-8
Third, the histological features described as presence of fibrotic tissue in the deep dermis in Figure 2, and dermal fibrosis with thick collagen deposition in Figure 31 do not confirm the existence of NSF.
Taken together, the case presented by Chuang, Kaneshiro, and Betancourt contains some unclear aspects; therefore, it is questionable whether the published case describes a patient with NSF or not. In the current presentation, the diagnosis NSF seems to be an overestimation.
NSF still is a poorly understood disorder. Therefore, exactly documented new cases could be of clinical value when providing interesting information. Even single cases could shed some light in the darkness of the pathological mechanisms of this entity. On the other hand, we should not mix the existing cohort of published NSF cases with other scleroderma-like diseases, because this will lead to a confusion. Moreover, such a practice could inhibit the discovery of the pathophysiology of NSF.
- Ingrid Böhm, MD
Author affiliations: Ingrid Böhm is a Physician in the Department of Diagnostics, Interventional and Pediatric Radiology at the University Hospital of Bern, Inselspital, University of Bern in Bern, Switzerland.
Correspondence: Ingrid Böhm ([email protected])
Disclosures: The author reports no conflict of interest with regard to this article.
References
1. Chuang K, Kaneshiro C, Betancourt J. Nephrogenic systemic fibrosis in a patient with multiple inflammatory disorders. Fed Pract . 2018;35(6):40-43.
2. Larson KN, Gagnon AL, Darling MD, Patterson JW, Cropley TG. Nephrogenic systemic fibrosis manifesting a decade after exposure to gadolinium. JAMA Dermatol. 2015;151(10):1117-1120.
3. US Food and Drug Administration. A Public Health Advisory. Gadolinium-containing contrast agents for magnetic resonance imaging (MRI). http://wayback.archive-it.org/7993/20170112033022/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformation forPatientsandProviders/ucm053112.htm. Published June 8, 2006. Accessed March 15, 2019.
4. Kanal E, Barkovich AJ, Bell C, et al; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007;188(6):1447-1474.
5. European Medicines Agency. Public statement: Vasovist and nephrogenic systemic fibrosis (NSF). https://www.ema.europa.eu/en/news/public-statement-vasovist-nephrogenic-systemic-fibrosis-nsf. Published February 7, 2007. Accessed March 15, 2019.
6. Luke JC. The etiology and modern treatment of varicose ulcer. Can Med Assoc J. 1940;43(3):217-221.
7. Paulsen E, Bygum A. Keratin gel as an adjuvant in the treatment of recalcitrant pyoderma gangrenosum ulcers: a case report. Acta Derm Venereol. 2019;99(2):234-235.
8. Boehm I, Bauer R. Low-dose methotrexate controls a severe form of polyarteritis nodosa. Arch Dermatol. 2000; 136(2):167-169.
Response:
We thank Drs. Heinz, van der Molen, and Roditi for their valuable response. The following is the opinion of the authors and is not representative of the views or policies of our institution. The patient in this case received a gadolinium-based contrast agent (GBCA) in 2015 and was diagnosed with nephrogenic systemic fibrosis (NSF) 8 weeks later. We agree with the correspondents that linear GBCAs should not be used in patients with eGFR < 30 mL/min/1.73 m2. To date, a few cases of patients who received GBCA and developed NSF since 2009 have unfortunately continued to be reported in the literature.1-3 Our intention in publishing this case was to provide ongoing education to the medical community regarding this serious condition to ensure prevention of future cases.
We thank Dr. Böhm for her important inquiry. The patient received a histopathologic diagnosis of NSF. The report from the patient’s left dorsal forearm skin punch biopsy was read by our pathologist as “fibrosis and inflammation consistent with nephrogenic systemic fibrosis,” a diagnosis agreed upon by our colleagues in the dermatology and rheumatology departments based on the rapidity of his symptom onset and progression. While we acknowledge that this patient had other inflammatory disorders of the skin that may have coexisted with the diagnosis, after weighing the preponderance of clinical evidence in support of the biopsy results, we believe that this represents a case of NSF, which is associated with high morbidity and mortality. Thankfully, the patient in this case engaged extensively in physical and occupational therapy and is still alive nearly 4 years later. We would like to thank all the letter writers for their correspondence.
Author Affiliations: Kelley Chuang and Casey Kaneshiro are Hospitalists and Jaime Betancourt is a Pulmonologist, all in the Department of Medicine at the VA Greater Los Angeles Healthcare System in California.
Correspondence: Kelley Chuang ([email protected])
Disclosures: The authors report no conflict of interest with regard to this article.
References
1. Aggarwal A, Froehlich AA, Essah P, Brinster N, High WA, Downs RW. Complications of nephrogenic systemic fibrosis following repeated exposure to gadolinium in a man with hypothyroidism: a case report. J Med Case Rep. 2011;5:566.
2. Fuah KW, Lim CT. Erythema nodosum masking nephrogenic systemic fibrosis as initial skin manifestation. BMC Nephrol. 2017;18(1):249.
3. Koratala A, Bhatti V. Nephrogenic systemic fibrosis. Clin Case Rep. 2017;5(7):1184-1185.
To the Editor:
We read with interest the case report of nephrogenic systemic fibrosis (NSF) by Chuang, Kaneshiro, and Betancourt in the June 2018 issue of Federal Practitioner.1 It was reported that a 61-year-old Hispanic male patient with a history of IV heroin abuse with end-stage renal disease (ESRD) secondary to membranous glomerulonephritis on hemodialysis and chronic hepatitis C infection received 15 mL gadoversetamide, a linear gadolinium-based contrast agent (GBCA) during magnetic resonance imaging (MRI) of the brain. Hemodialysis was performed 18 hours after the contrast administration.
Eight weeks after his initial presentation, the patient developed pyoderma gangrenosum on his right forearm, which was treated with high-dose steroids. He then developed thickening and induration of his bilateral forearm skin with peau d’orange appearance. NSF was confirmed by a skin biopsy. The patient developed contractures of his upper and lower extremities and was finally wheelchair bound.
This case is very concerning since no NSF cases in patients receiving GBCA have been published since 2009. Unfortunately, the authors give no information on the occurrence of this particular case. Thus, it is unclear whether this case was observed before or after the switch to macrocyclic agents in patients with reduced renal function. The reported patient with ESRD was on hemodialysis and received 15 mL gadoversetamide during MRI of the brain. In 2007 the ESUR (European Society of Urogenital Radiology) published guidelines indicating linear GBCA (gadodiamide, gadoversetamide, gadopentetate dimeglumine) as high-risk agents that may not be used in patients with eGFR < 30 mL/min/1.73 m2.2,3
Consequently in 2007, the European Medicines Agency contraindicated these linear GBCA in patients with chronic kidney disease grades 4 and 5. Also in 2007 the US Food and Drug Administration (FDA) requested a revision of the prescribing information for all 5 GBCA approved in the US.4 In response to accumulating more informative data, in 2010 the FDA again used this class labeling approach to more explicitly describe differences in NSF risks among the agents.4 FDA regulation and contraindication of the use of low-stability GBCA in patients with advanced renal impairment and robust local policies on the safe use of these agents have resulted in marked reduction in the prevalence of NSF in the US. This case report needs to clarify why a high-risk linear agent was administered to a patient with ESRD.
In 2006 Grobner and Marckmann and colleagues reported their observations of a previously unrecognized link between exposure to gadodiamide and the development of NSF.5,6 It soon became clear that NSF is a delayed adverse contrast reaction that may cause severe disability and even death. Advanced renal disease and high-risk linear GBCA are the main factors in the pathogenesis of NSF. Additionally, the dose of the agent may play a role. NSF can occur from hours to years after exposure to GBCA. Not all patients with severe kidney disease exposed to high-risk agents developed NSF. Thus, additional factors were proposed to play a role in the pathogenesis of NSF. Among those factors were erythropoietin, metabolic acidosis, anion gap, iron, increased phosphate, zinc loss, proinflammatory conditions/inflammation and angiotensin-converting enzyme (ACE) inhibitors.7 Although there is little proof with these assumptions, special care must be taken as shown by this reported patient with multiple inflammatory disorders.
- Gertraud Heinz, MD, MBA; Aart van der Molen, MD; and Giles Roditi, MD; on behalf of the ESUR Contrast Media Safety Committee
Author affiliations: Gertraud Heinz is former President ESUR and Head of the Department of Radiology, Diagnostics and Intervention University Hospital St. Pölten Karl Landsteiner University of Health Sciences.
Correspondence: Gertraud Heinz (gertraud.heinz@stpoelten .lknoe.at)
Disclosures: The authors report no conflict of interest with regard to this article.
References
1. Chuang K, Kaneshiro C, Betancourt J. Nephrogenic systemic fibrosis in a patient with multiple inflammatory disorders. Fed Pract. 2018;35(6):40-43.
2. Thomsen HS; European Society of Urogenital Radiology (ESUR). ESUR guideline: gadolinium based contrast media and nephrogenic systemic fibrosis. Eur Radiol. 2007;17(10):2692-2696.
3. Thomsen HS, Morcos SK, Almén T, et al; ESUR Contrast Medium Safety Committee. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Media Safety Committee guidelines. Eur Radiol. 2013;23(2):307-318
4. Yang L, Krefting I, Gorovets A, et al. Nephrogenic systemic fibrosis and class labeling of gadolinium-based agents by the Food and Drug Administration. Radiology. 2012;265(1):248-253.
5. Grobner T. Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006;21(4):1104-1108.
6. Marckmann P, Skov L, Rossen K, et al. Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol. 2006;17(9):2359-2362.
7. Thomsen HS, Bennett CL. Six years after. Acta Radiol. 2012;53(8):827-829.
To the Editor:
With great interest, I read the case report by Chuang, Kaneshiro, and Betancourt.1 Patients with nephrogenic systemic fibrosis (NSF) are of special interest because the disease is still unclear as mentioned by the authors. Although new cases may occur,2 this case raises some concerns that I would like to address.
First, it would be of great interest to know the date when the patient received the high-risk gadolinium-based contrast agent (GBCA) gadoversetamide. Unfortunately, the authors did not mention the date of the injection of the GBCA that probably caused NSF. Due to the obvious association between the applications of special GBCAs in 2006, the US Food and Drug Administration (FDA) warned physicians not to inject these contrast agents in patients with compromised kidney function.3 Moreover, in 2007 the American College of Radiology (ACR) published guidelines for the safe use of GBCAs in patients with renal failure.4 Also, the European Medicines Agency (EMA) demanded that companies provide warning in product inserts about the acquisition of NSF in patients with severe kidney injury.5
Second, the clinical illustration of the case is inadequate. In the manuscript, we read that the patient acquired NSF-characteristic lesions like peau d’orange skin lesions and contractures of his extremities, but unfortunately, Chuang, Kaneshiro, and Betancourt did not provide figures that show them. On the other hand, Figure 1 shows an uncharacteristic dermal induration around inflammatory and ulcerated skin lesion (pyoderma gangrenosum).1 Such clinical signs are well known and occur perilesional of different conditions independently of NSF.6-8
Third, the histological features described as presence of fibrotic tissue in the deep dermis in Figure 2, and dermal fibrosis with thick collagen deposition in Figure 31 do not confirm the existence of NSF.
Taken together, the case presented by Chuang, Kaneshiro, and Betancourt contains some unclear aspects; therefore, it is questionable whether the published case describes a patient with NSF or not. In the current presentation, the diagnosis NSF seems to be an overestimation.
NSF still is a poorly understood disorder. Therefore, exactly documented new cases could be of clinical value when providing interesting information. Even single cases could shed some light in the darkness of the pathological mechanisms of this entity. On the other hand, we should not mix the existing cohort of published NSF cases with other scleroderma-like diseases, because this will lead to a confusion. Moreover, such a practice could inhibit the discovery of the pathophysiology of NSF.
- Ingrid Böhm, MD
Author affiliations: Ingrid Böhm is a Physician in the Department of Diagnostics, Interventional and Pediatric Radiology at the University Hospital of Bern, Inselspital, University of Bern in Bern, Switzerland.
Correspondence: Ingrid Böhm ([email protected])
Disclosures: The author reports no conflict of interest with regard to this article.
References
1. Chuang K, Kaneshiro C, Betancourt J. Nephrogenic systemic fibrosis in a patient with multiple inflammatory disorders. Fed Pract . 2018;35(6):40-43.
2. Larson KN, Gagnon AL, Darling MD, Patterson JW, Cropley TG. Nephrogenic systemic fibrosis manifesting a decade after exposure to gadolinium. JAMA Dermatol. 2015;151(10):1117-1120.
3. US Food and Drug Administration. A Public Health Advisory. Gadolinium-containing contrast agents for magnetic resonance imaging (MRI). http://wayback.archive-it.org/7993/20170112033022/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformation forPatientsandProviders/ucm053112.htm. Published June 8, 2006. Accessed March 15, 2019.
4. Kanal E, Barkovich AJ, Bell C, et al; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007;188(6):1447-1474.
5. European Medicines Agency. Public statement: Vasovist and nephrogenic systemic fibrosis (NSF). https://www.ema.europa.eu/en/news/public-statement-vasovist-nephrogenic-systemic-fibrosis-nsf. Published February 7, 2007. Accessed March 15, 2019.
6. Luke JC. The etiology and modern treatment of varicose ulcer. Can Med Assoc J. 1940;43(3):217-221.
7. Paulsen E, Bygum A. Keratin gel as an adjuvant in the treatment of recalcitrant pyoderma gangrenosum ulcers: a case report. Acta Derm Venereol. 2019;99(2):234-235.
8. Boehm I, Bauer R. Low-dose methotrexate controls a severe form of polyarteritis nodosa. Arch Dermatol. 2000; 136(2):167-169.
Response:
We thank Drs. Heinz, van der Molen, and Roditi for their valuable response. The following is the opinion of the authors and is not representative of the views or policies of our institution. The patient in this case received a gadolinium-based contrast agent (GBCA) in 2015 and was diagnosed with nephrogenic systemic fibrosis (NSF) 8 weeks later. We agree with the correspondents that linear GBCAs should not be used in patients with eGFR < 30 mL/min/1.73 m2. To date, a few cases of patients who received GBCA and developed NSF since 2009 have unfortunately continued to be reported in the literature.1-3 Our intention in publishing this case was to provide ongoing education to the medical community regarding this serious condition to ensure prevention of future cases.
We thank Dr. Böhm for her important inquiry. The patient received a histopathologic diagnosis of NSF. The report from the patient’s left dorsal forearm skin punch biopsy was read by our pathologist as “fibrosis and inflammation consistent with nephrogenic systemic fibrosis,” a diagnosis agreed upon by our colleagues in the dermatology and rheumatology departments based on the rapidity of his symptom onset and progression. While we acknowledge that this patient had other inflammatory disorders of the skin that may have coexisted with the diagnosis, after weighing the preponderance of clinical evidence in support of the biopsy results, we believe that this represents a case of NSF, which is associated with high morbidity and mortality. Thankfully, the patient in this case engaged extensively in physical and occupational therapy and is still alive nearly 4 years later. We would like to thank all the letter writers for their correspondence.
Author Affiliations: Kelley Chuang and Casey Kaneshiro are Hospitalists and Jaime Betancourt is a Pulmonologist, all in the Department of Medicine at the VA Greater Los Angeles Healthcare System in California.
Correspondence: Kelley Chuang ([email protected])
Disclosures: The authors report no conflict of interest with regard to this article.
References
1. Aggarwal A, Froehlich AA, Essah P, Brinster N, High WA, Downs RW. Complications of nephrogenic systemic fibrosis following repeated exposure to gadolinium in a man with hypothyroidism: a case report. J Med Case Rep. 2011;5:566.
2. Fuah KW, Lim CT. Erythema nodosum masking nephrogenic systemic fibrosis as initial skin manifestation. BMC Nephrol. 2017;18(1):249.
3. Koratala A, Bhatti V. Nephrogenic systemic fibrosis. Clin Case Rep. 2017;5(7):1184-1185.
To the Editor:
We read with interest the case report of nephrogenic systemic fibrosis (NSF) by Chuang, Kaneshiro, and Betancourt in the June 2018 issue of Federal Practitioner.1 It was reported that a 61-year-old Hispanic male patient with a history of IV heroin abuse with end-stage renal disease (ESRD) secondary to membranous glomerulonephritis on hemodialysis and chronic hepatitis C infection received 15 mL gadoversetamide, a linear gadolinium-based contrast agent (GBCA) during magnetic resonance imaging (MRI) of the brain. Hemodialysis was performed 18 hours after the contrast administration.
Eight weeks after his initial presentation, the patient developed pyoderma gangrenosum on his right forearm, which was treated with high-dose steroids. He then developed thickening and induration of his bilateral forearm skin with peau d’orange appearance. NSF was confirmed by a skin biopsy. The patient developed contractures of his upper and lower extremities and was finally wheelchair bound.
This case is very concerning since no NSF cases in patients receiving GBCA have been published since 2009. Unfortunately, the authors give no information on the occurrence of this particular case. Thus, it is unclear whether this case was observed before or after the switch to macrocyclic agents in patients with reduced renal function. The reported patient with ESRD was on hemodialysis and received 15 mL gadoversetamide during MRI of the brain. In 2007 the ESUR (European Society of Urogenital Radiology) published guidelines indicating linear GBCA (gadodiamide, gadoversetamide, gadopentetate dimeglumine) as high-risk agents that may not be used in patients with eGFR < 30 mL/min/1.73 m2.2,3
Consequently in 2007, the European Medicines Agency contraindicated these linear GBCA in patients with chronic kidney disease grades 4 and 5. Also in 2007 the US Food and Drug Administration (FDA) requested a revision of the prescribing information for all 5 GBCA approved in the US.4 In response to accumulating more informative data, in 2010 the FDA again used this class labeling approach to more explicitly describe differences in NSF risks among the agents.4 FDA regulation and contraindication of the use of low-stability GBCA in patients with advanced renal impairment and robust local policies on the safe use of these agents have resulted in marked reduction in the prevalence of NSF in the US. This case report needs to clarify why a high-risk linear agent was administered to a patient with ESRD.
In 2006 Grobner and Marckmann and colleagues reported their observations of a previously unrecognized link between exposure to gadodiamide and the development of NSF.5,6 It soon became clear that NSF is a delayed adverse contrast reaction that may cause severe disability and even death. Advanced renal disease and high-risk linear GBCA are the main factors in the pathogenesis of NSF. Additionally, the dose of the agent may play a role. NSF can occur from hours to years after exposure to GBCA. Not all patients with severe kidney disease exposed to high-risk agents developed NSF. Thus, additional factors were proposed to play a role in the pathogenesis of NSF. Among those factors were erythropoietin, metabolic acidosis, anion gap, iron, increased phosphate, zinc loss, proinflammatory conditions/inflammation and angiotensin-converting enzyme (ACE) inhibitors.7 Although there is little proof with these assumptions, special care must be taken as shown by this reported patient with multiple inflammatory disorders.
- Gertraud Heinz, MD, MBA; Aart van der Molen, MD; and Giles Roditi, MD; on behalf of the ESUR Contrast Media Safety Committee
Author affiliations: Gertraud Heinz is former President ESUR and Head of the Department of Radiology, Diagnostics and Intervention University Hospital St. Pölten Karl Landsteiner University of Health Sciences.
Correspondence: Gertraud Heinz (gertraud.heinz@stpoelten .lknoe.at)
Disclosures: The authors report no conflict of interest with regard to this article.
References
1. Chuang K, Kaneshiro C, Betancourt J. Nephrogenic systemic fibrosis in a patient with multiple inflammatory disorders. Fed Pract. 2018;35(6):40-43.
2. Thomsen HS; European Society of Urogenital Radiology (ESUR). ESUR guideline: gadolinium based contrast media and nephrogenic systemic fibrosis. Eur Radiol. 2007;17(10):2692-2696.
3. Thomsen HS, Morcos SK, Almén T, et al; ESUR Contrast Medium Safety Committee. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Media Safety Committee guidelines. Eur Radiol. 2013;23(2):307-318
4. Yang L, Krefting I, Gorovets A, et al. Nephrogenic systemic fibrosis and class labeling of gadolinium-based agents by the Food and Drug Administration. Radiology. 2012;265(1):248-253.
5. Grobner T. Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006;21(4):1104-1108.
6. Marckmann P, Skov L, Rossen K, et al. Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol. 2006;17(9):2359-2362.
7. Thomsen HS, Bennett CL. Six years after. Acta Radiol. 2012;53(8):827-829.
To the Editor:
With great interest, I read the case report by Chuang, Kaneshiro, and Betancourt.1 Patients with nephrogenic systemic fibrosis (NSF) are of special interest because the disease is still unclear as mentioned by the authors. Although new cases may occur,2 this case raises some concerns that I would like to address.
First, it would be of great interest to know the date when the patient received the high-risk gadolinium-based contrast agent (GBCA) gadoversetamide. Unfortunately, the authors did not mention the date of the injection of the GBCA that probably caused NSF. Due to the obvious association between the applications of special GBCAs in 2006, the US Food and Drug Administration (FDA) warned physicians not to inject these contrast agents in patients with compromised kidney function.3 Moreover, in 2007 the American College of Radiology (ACR) published guidelines for the safe use of GBCAs in patients with renal failure.4 Also, the European Medicines Agency (EMA) demanded that companies provide warning in product inserts about the acquisition of NSF in patients with severe kidney injury.5
Second, the clinical illustration of the case is inadequate. In the manuscript, we read that the patient acquired NSF-characteristic lesions like peau d’orange skin lesions and contractures of his extremities, but unfortunately, Chuang, Kaneshiro, and Betancourt did not provide figures that show them. On the other hand, Figure 1 shows an uncharacteristic dermal induration around inflammatory and ulcerated skin lesion (pyoderma gangrenosum).1 Such clinical signs are well known and occur perilesional of different conditions independently of NSF.6-8
Third, the histological features described as presence of fibrotic tissue in the deep dermis in Figure 2, and dermal fibrosis with thick collagen deposition in Figure 31 do not confirm the existence of NSF.
Taken together, the case presented by Chuang, Kaneshiro, and Betancourt contains some unclear aspects; therefore, it is questionable whether the published case describes a patient with NSF or not. In the current presentation, the diagnosis NSF seems to be an overestimation.
NSF still is a poorly understood disorder. Therefore, exactly documented new cases could be of clinical value when providing interesting information. Even single cases could shed some light in the darkness of the pathological mechanisms of this entity. On the other hand, we should not mix the existing cohort of published NSF cases with other scleroderma-like diseases, because this will lead to a confusion. Moreover, such a practice could inhibit the discovery of the pathophysiology of NSF.
- Ingrid Böhm, MD
Author affiliations: Ingrid Böhm is a Physician in the Department of Diagnostics, Interventional and Pediatric Radiology at the University Hospital of Bern, Inselspital, University of Bern in Bern, Switzerland.
Correspondence: Ingrid Böhm ([email protected])
Disclosures: The author reports no conflict of interest with regard to this article.
References
1. Chuang K, Kaneshiro C, Betancourt J. Nephrogenic systemic fibrosis in a patient with multiple inflammatory disorders. Fed Pract . 2018;35(6):40-43.
2. Larson KN, Gagnon AL, Darling MD, Patterson JW, Cropley TG. Nephrogenic systemic fibrosis manifesting a decade after exposure to gadolinium. JAMA Dermatol. 2015;151(10):1117-1120.
3. US Food and Drug Administration. A Public Health Advisory. Gadolinium-containing contrast agents for magnetic resonance imaging (MRI). http://wayback.archive-it.org/7993/20170112033022/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformation forPatientsandProviders/ucm053112.htm. Published June 8, 2006. Accessed March 15, 2019.
4. Kanal E, Barkovich AJ, Bell C, et al; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007;188(6):1447-1474.
5. European Medicines Agency. Public statement: Vasovist and nephrogenic systemic fibrosis (NSF). https://www.ema.europa.eu/en/news/public-statement-vasovist-nephrogenic-systemic-fibrosis-nsf. Published February 7, 2007. Accessed March 15, 2019.
6. Luke JC. The etiology and modern treatment of varicose ulcer. Can Med Assoc J. 1940;43(3):217-221.
7. Paulsen E, Bygum A. Keratin gel as an adjuvant in the treatment of recalcitrant pyoderma gangrenosum ulcers: a case report. Acta Derm Venereol. 2019;99(2):234-235.
8. Boehm I, Bauer R. Low-dose methotrexate controls a severe form of polyarteritis nodosa. Arch Dermatol. 2000; 136(2):167-169.
Response:
We thank Drs. Heinz, van der Molen, and Roditi for their valuable response. The following is the opinion of the authors and is not representative of the views or policies of our institution. The patient in this case received a gadolinium-based contrast agent (GBCA) in 2015 and was diagnosed with nephrogenic systemic fibrosis (NSF) 8 weeks later. We agree with the correspondents that linear GBCAs should not be used in patients with eGFR < 30 mL/min/1.73 m2. To date, a few cases of patients who received GBCA and developed NSF since 2009 have unfortunately continued to be reported in the literature.1-3 Our intention in publishing this case was to provide ongoing education to the medical community regarding this serious condition to ensure prevention of future cases.
We thank Dr. Böhm for her important inquiry. The patient received a histopathologic diagnosis of NSF. The report from the patient’s left dorsal forearm skin punch biopsy was read by our pathologist as “fibrosis and inflammation consistent with nephrogenic systemic fibrosis,” a diagnosis agreed upon by our colleagues in the dermatology and rheumatology departments based on the rapidity of his symptom onset and progression. While we acknowledge that this patient had other inflammatory disorders of the skin that may have coexisted with the diagnosis, after weighing the preponderance of clinical evidence in support of the biopsy results, we believe that this represents a case of NSF, which is associated with high morbidity and mortality. Thankfully, the patient in this case engaged extensively in physical and occupational therapy and is still alive nearly 4 years later. We would like to thank all the letter writers for their correspondence.
Author Affiliations: Kelley Chuang and Casey Kaneshiro are Hospitalists and Jaime Betancourt is a Pulmonologist, all in the Department of Medicine at the VA Greater Los Angeles Healthcare System in California.
Correspondence: Kelley Chuang ([email protected])
Disclosures: The authors report no conflict of interest with regard to this article.
References
1. Aggarwal A, Froehlich AA, Essah P, Brinster N, High WA, Downs RW. Complications of nephrogenic systemic fibrosis following repeated exposure to gadolinium in a man with hypothyroidism: a case report. J Med Case Rep. 2011;5:566.
2. Fuah KW, Lim CT. Erythema nodosum masking nephrogenic systemic fibrosis as initial skin manifestation. BMC Nephrol. 2017;18(1):249.
3. Koratala A, Bhatti V. Nephrogenic systemic fibrosis. Clin Case Rep. 2017;5(7):1184-1185.
Revering Furry Valor
National K9 Veterans Day celebrates the loyalty, bravery, and sacrifice of canine warriors. On March 13, 1942, canines officially became members of the Armed Services, with the Army’s founding of its New War Dog Program, more popularly known as the K9 Corps. The dogs underwent basic training and then entered more specialized preparation just as human soldiers did.2 There had been unofficial dogs of war who served courageously and selflessly in almost all of our armed conflicts.3 Indeed, the title of this column is taken from a wonderful article of the same name narrating the heroism of dogs in the 2 world wars.4
The dedication of canines to those who serve is not confined to combat or even active duty. Thousands of military and veteran men and women have benefited immensely from their relationship with service and emotional support dogs.
Before I continue, let me state 2 important limitations of this column. First, I am a dog person. Of course, veterans have formed healing and caring relationships with many types of companions. Equine therapy is increasingly recognized as a powerful means of helping veterans reduce distress and find purpose.5 Nevertheless, for this column, I will focus exclusively on dogs. Second, there are many worthy organizations, projects, and programs that pair veterans with therapeutic dogs inside and outside the VA. I am in no way an expert and will invariably neglect many of these positive initiatives in this brief review.
The long, proud history of canines in the military and the many moving stories of men and women in and out of uniform for whom dogs have been life changing, if not life-saving, have created 2 ethical dilemmas for the VA that I examine here. Both dilemmas pivot on the terms of official recognition of service dogs, the benefits, and who can qualify for them in the VA.
Under VA regulation and VHA policy, a service companion only can be a dog that is individually trained to do work or perform tasks to assist a person with a disability; dogs whose sole function is to provide emotional support, well-being, comfort, or companionship are not considered service pets.6
Prior to the widespread implementation of VHA Directive 1188, some VA medical centers had, pardon the pun, “gone to the dogs,” in the sense that depending on the facility, emotional support companions were found in almost every area of hospitals and clinics. Their presence enabled many patients to feel comfortable enough to seek medical and mental health care, as the canine companion gave them a sense of security and calm. But some dogs had not received the extensive training that enables a service dog to follow commands and handle the stimulation of a large, busy hospital with all its sights, sounds, and smells. Infectious disease, police, and public health authorities raised legitimate public health and safety risks about the increasing number of dogs on VA grounds who were not formally certified as service dogs. In response to those concerns, in August 2015, VHA declared a uniform policy that restricted service dogs access to VA property.7 This was, as with most health policy, a necessary, albeit utilitarian decision, that the common good outweighed that of individual veterans. Unfortunately, some veterans experienced the decision as a form of psychological rejection, and others no longer felt able mentally or physically to master the stresses of seeking health care without a canine companion.
A valid question to ask is why couldn’t the most vulnerable of these veterans, for instance those with severe mental health conditions, have service dogs that could accompany them into at least most areas of the medical center? Part of the reason is cost: Some training organizations estimate it may cost as much as $27,000 to train service dogs.8 Though there are many wonderful volunteer and not-for-profit organizations that train mostly shelter dogs and their veteran handlers—a double rescue—the lengthy process and expense means that many veterans wait years for a companion.
Congressional representatives, ethicists, veterans advocates, and canine therapy groups claim that this was unjust discrimination against those suffering with the equally, if not more disabling, mental health conditions.9 For many years, the VA has done a very good deed: For those who qualify for a service dog, VA pays for veterinary care and the equipment to handle the dog, but not boarding, grooming, food, and other miscellaneous expenses.10 But until 2016, those veterans approved for service dogs in the main had sensory or physical disabilities.
A partial breakthrough emerged when the Center for Compassionate Care Innovation launched the Mental Health Mobility Service Dogs Program that expanded veterinary health benefits to veterans with a “substantial mobility limitation.” For example, veterans whose hypervigilance and hyperarousal are so severe that they cannot attend medical appointments.11
VA experts argue that at this time there is insufficient evidence to fund service dogs as even adjunctive PTSD therapy for the hundreds of veterans who might potentially qualify. It becomes an ethical question of prudent stewardship of public funds and trust. There is certainly plenty of compelling anecdotal testimony that companion canines are a high-benefit, relatively low-risk form of complementary and integrated therapy for the spectrum of trauma disorders that afflict many of the men and women who served in our conflicts. Demonstrating those positive effects scientifically may be more difficult than it seems, although early evidence is promising, and the VA is intensively researching the question.12 For some veterans and their legislators, the VA has not gone far enough, fast enough in mainstreaming therapy dogs, they are calling for VA to expand veterans’ benefits to include mental health service dogs and to define what benefits would be covered.
National K9 Veterans Day is an important step toward giving dogs of war the homage they have earned, as are increasing efforts to ensure care for military canines throughout their life cycle. But as the seventeenth century poet John Milton wrote when he reflected on his own worth despite his blindness, “Those also serve who only stand and wait.”13 The institutions charged to care for those the battle has most burdened are still trying to discover how to properly and proportionately revere that kind of furry valor.
1. Schweitzer A. Civilization and Ethics. Naish JP, trans. London, England: A. & C. Black; 1923.
2. Bergeron AW Jr. War dogs: the birth of the K-9 Corps. https://www.army.mil/article/7463/war_dogs_the_birth_of_the_k_9_corps. Published February 14, 2008. Accessed March 22, 2019.
3. Nye L. A brief history of dogs in warfare. https://www.military.com/undertheradar/2017/03/brief-history-dogs-warfare. Published March 20, 2017. Accessed March 24, 2019.
4. Liao S. Furry valor: The tactical dogs of WW I and II. Vet Herit. 2016;39(1):24-29.
5. Romaniuk M, Evans J, Kidd C. Evaluation of an equine-assisted therapy program for veterans who identify as ‘wounded, injured, or ill’ and their partners. PLoS One. 2018;13(9):e0203943.
6. US Department of Veterans Affairs. Frequently asked questions: service animals on VA property. https://www.blogs.va.gov/VAntage/wp-content/uploads/2015/08/FAQs_RegulationsAboutAnimalsonVAProperty.pdf. Published Accessed March 24, 2019.
7. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1188: animals on Veterans Health Administration (VHA) property. https://www.boise.va.gov/docs/Service_Animal_Policy.pdf August 26, 2015.
8. Brulliard K. For military veterans suffering from PTSD, are service dogs good therapy? Washington Post. March 27, 2018.
9. Weinmeyer R. Service dogs for veterans with post-traumatic stress disorder. AMA J Ethics. 2015;17(6):547-552.
10. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Care Services. Guide and service dogs. https://www.prosthetics.va.gov/serviceandguidedogs.asp. Updated August 18, 2016. Accessed March 24, 2019.
11. US Department of Veterans Affairs. VA pilots program to expand veterinary benefits for mental health mobility service dogs. https://www.blogs.va.gov/VAntage/33379/va-pilots-program-to-expand-veterinary-health-benefit-for-mental-health-mobility-service-dogs. Published Accessed March 24, 2019.
12. Yarborough BJH, Stumbo SP, Yarborough MT, Owen-Smith A, Green CA. Benefits and challenges of using service dogs for veterans with posttraumatic stress disorder. Psychiatr Rehabil J. 2018;41(2):118-124.
National K9 Veterans Day celebrates the loyalty, bravery, and sacrifice of canine warriors. On March 13, 1942, canines officially became members of the Armed Services, with the Army’s founding of its New War Dog Program, more popularly known as the K9 Corps. The dogs underwent basic training and then entered more specialized preparation just as human soldiers did.2 There had been unofficial dogs of war who served courageously and selflessly in almost all of our armed conflicts.3 Indeed, the title of this column is taken from a wonderful article of the same name narrating the heroism of dogs in the 2 world wars.4
The dedication of canines to those who serve is not confined to combat or even active duty. Thousands of military and veteran men and women have benefited immensely from their relationship with service and emotional support dogs.
Before I continue, let me state 2 important limitations of this column. First, I am a dog person. Of course, veterans have formed healing and caring relationships with many types of companions. Equine therapy is increasingly recognized as a powerful means of helping veterans reduce distress and find purpose.5 Nevertheless, for this column, I will focus exclusively on dogs. Second, there are many worthy organizations, projects, and programs that pair veterans with therapeutic dogs inside and outside the VA. I am in no way an expert and will invariably neglect many of these positive initiatives in this brief review.
The long, proud history of canines in the military and the many moving stories of men and women in and out of uniform for whom dogs have been life changing, if not life-saving, have created 2 ethical dilemmas for the VA that I examine here. Both dilemmas pivot on the terms of official recognition of service dogs, the benefits, and who can qualify for them in the VA.
Under VA regulation and VHA policy, a service companion only can be a dog that is individually trained to do work or perform tasks to assist a person with a disability; dogs whose sole function is to provide emotional support, well-being, comfort, or companionship are not considered service pets.6
Prior to the widespread implementation of VHA Directive 1188, some VA medical centers had, pardon the pun, “gone to the dogs,” in the sense that depending on the facility, emotional support companions were found in almost every area of hospitals and clinics. Their presence enabled many patients to feel comfortable enough to seek medical and mental health care, as the canine companion gave them a sense of security and calm. But some dogs had not received the extensive training that enables a service dog to follow commands and handle the stimulation of a large, busy hospital with all its sights, sounds, and smells. Infectious disease, police, and public health authorities raised legitimate public health and safety risks about the increasing number of dogs on VA grounds who were not formally certified as service dogs. In response to those concerns, in August 2015, VHA declared a uniform policy that restricted service dogs access to VA property.7 This was, as with most health policy, a necessary, albeit utilitarian decision, that the common good outweighed that of individual veterans. Unfortunately, some veterans experienced the decision as a form of psychological rejection, and others no longer felt able mentally or physically to master the stresses of seeking health care without a canine companion.
A valid question to ask is why couldn’t the most vulnerable of these veterans, for instance those with severe mental health conditions, have service dogs that could accompany them into at least most areas of the medical center? Part of the reason is cost: Some training organizations estimate it may cost as much as $27,000 to train service dogs.8 Though there are many wonderful volunteer and not-for-profit organizations that train mostly shelter dogs and their veteran handlers—a double rescue—the lengthy process and expense means that many veterans wait years for a companion.
Congressional representatives, ethicists, veterans advocates, and canine therapy groups claim that this was unjust discrimination against those suffering with the equally, if not more disabling, mental health conditions.9 For many years, the VA has done a very good deed: For those who qualify for a service dog, VA pays for veterinary care and the equipment to handle the dog, but not boarding, grooming, food, and other miscellaneous expenses.10 But until 2016, those veterans approved for service dogs in the main had sensory or physical disabilities.
A partial breakthrough emerged when the Center for Compassionate Care Innovation launched the Mental Health Mobility Service Dogs Program that expanded veterinary health benefits to veterans with a “substantial mobility limitation.” For example, veterans whose hypervigilance and hyperarousal are so severe that they cannot attend medical appointments.11
VA experts argue that at this time there is insufficient evidence to fund service dogs as even adjunctive PTSD therapy for the hundreds of veterans who might potentially qualify. It becomes an ethical question of prudent stewardship of public funds and trust. There is certainly plenty of compelling anecdotal testimony that companion canines are a high-benefit, relatively low-risk form of complementary and integrated therapy for the spectrum of trauma disorders that afflict many of the men and women who served in our conflicts. Demonstrating those positive effects scientifically may be more difficult than it seems, although early evidence is promising, and the VA is intensively researching the question.12 For some veterans and their legislators, the VA has not gone far enough, fast enough in mainstreaming therapy dogs, they are calling for VA to expand veterans’ benefits to include mental health service dogs and to define what benefits would be covered.
National K9 Veterans Day is an important step toward giving dogs of war the homage they have earned, as are increasing efforts to ensure care for military canines throughout their life cycle. But as the seventeenth century poet John Milton wrote when he reflected on his own worth despite his blindness, “Those also serve who only stand and wait.”13 The institutions charged to care for those the battle has most burdened are still trying to discover how to properly and proportionately revere that kind of furry valor.
National K9 Veterans Day celebrates the loyalty, bravery, and sacrifice of canine warriors. On March 13, 1942, canines officially became members of the Armed Services, with the Army’s founding of its New War Dog Program, more popularly known as the K9 Corps. The dogs underwent basic training and then entered more specialized preparation just as human soldiers did.2 There had been unofficial dogs of war who served courageously and selflessly in almost all of our armed conflicts.3 Indeed, the title of this column is taken from a wonderful article of the same name narrating the heroism of dogs in the 2 world wars.4
The dedication of canines to those who serve is not confined to combat or even active duty. Thousands of military and veteran men and women have benefited immensely from their relationship with service and emotional support dogs.
Before I continue, let me state 2 important limitations of this column. First, I am a dog person. Of course, veterans have formed healing and caring relationships with many types of companions. Equine therapy is increasingly recognized as a powerful means of helping veterans reduce distress and find purpose.5 Nevertheless, for this column, I will focus exclusively on dogs. Second, there are many worthy organizations, projects, and programs that pair veterans with therapeutic dogs inside and outside the VA. I am in no way an expert and will invariably neglect many of these positive initiatives in this brief review.
The long, proud history of canines in the military and the many moving stories of men and women in and out of uniform for whom dogs have been life changing, if not life-saving, have created 2 ethical dilemmas for the VA that I examine here. Both dilemmas pivot on the terms of official recognition of service dogs, the benefits, and who can qualify for them in the VA.
Under VA regulation and VHA policy, a service companion only can be a dog that is individually trained to do work or perform tasks to assist a person with a disability; dogs whose sole function is to provide emotional support, well-being, comfort, or companionship are not considered service pets.6
Prior to the widespread implementation of VHA Directive 1188, some VA medical centers had, pardon the pun, “gone to the dogs,” in the sense that depending on the facility, emotional support companions were found in almost every area of hospitals and clinics. Their presence enabled many patients to feel comfortable enough to seek medical and mental health care, as the canine companion gave them a sense of security and calm. But some dogs had not received the extensive training that enables a service dog to follow commands and handle the stimulation of a large, busy hospital with all its sights, sounds, and smells. Infectious disease, police, and public health authorities raised legitimate public health and safety risks about the increasing number of dogs on VA grounds who were not formally certified as service dogs. In response to those concerns, in August 2015, VHA declared a uniform policy that restricted service dogs access to VA property.7 This was, as with most health policy, a necessary, albeit utilitarian decision, that the common good outweighed that of individual veterans. Unfortunately, some veterans experienced the decision as a form of psychological rejection, and others no longer felt able mentally or physically to master the stresses of seeking health care without a canine companion.
A valid question to ask is why couldn’t the most vulnerable of these veterans, for instance those with severe mental health conditions, have service dogs that could accompany them into at least most areas of the medical center? Part of the reason is cost: Some training organizations estimate it may cost as much as $27,000 to train service dogs.8 Though there are many wonderful volunteer and not-for-profit organizations that train mostly shelter dogs and their veteran handlers—a double rescue—the lengthy process and expense means that many veterans wait years for a companion.
Congressional representatives, ethicists, veterans advocates, and canine therapy groups claim that this was unjust discrimination against those suffering with the equally, if not more disabling, mental health conditions.9 For many years, the VA has done a very good deed: For those who qualify for a service dog, VA pays for veterinary care and the equipment to handle the dog, but not boarding, grooming, food, and other miscellaneous expenses.10 But until 2016, those veterans approved for service dogs in the main had sensory or physical disabilities.
A partial breakthrough emerged when the Center for Compassionate Care Innovation launched the Mental Health Mobility Service Dogs Program that expanded veterinary health benefits to veterans with a “substantial mobility limitation.” For example, veterans whose hypervigilance and hyperarousal are so severe that they cannot attend medical appointments.11
VA experts argue that at this time there is insufficient evidence to fund service dogs as even adjunctive PTSD therapy for the hundreds of veterans who might potentially qualify. It becomes an ethical question of prudent stewardship of public funds and trust. There is certainly plenty of compelling anecdotal testimony that companion canines are a high-benefit, relatively low-risk form of complementary and integrated therapy for the spectrum of trauma disorders that afflict many of the men and women who served in our conflicts. Demonstrating those positive effects scientifically may be more difficult than it seems, although early evidence is promising, and the VA is intensively researching the question.12 For some veterans and their legislators, the VA has not gone far enough, fast enough in mainstreaming therapy dogs, they are calling for VA to expand veterans’ benefits to include mental health service dogs and to define what benefits would be covered.
National K9 Veterans Day is an important step toward giving dogs of war the homage they have earned, as are increasing efforts to ensure care for military canines throughout their life cycle. But as the seventeenth century poet John Milton wrote when he reflected on his own worth despite his blindness, “Those also serve who only stand and wait.”13 The institutions charged to care for those the battle has most burdened are still trying to discover how to properly and proportionately revere that kind of furry valor.
1. Schweitzer A. Civilization and Ethics. Naish JP, trans. London, England: A. & C. Black; 1923.
2. Bergeron AW Jr. War dogs: the birth of the K-9 Corps. https://www.army.mil/article/7463/war_dogs_the_birth_of_the_k_9_corps. Published February 14, 2008. Accessed March 22, 2019.
3. Nye L. A brief history of dogs in warfare. https://www.military.com/undertheradar/2017/03/brief-history-dogs-warfare. Published March 20, 2017. Accessed March 24, 2019.
4. Liao S. Furry valor: The tactical dogs of WW I and II. Vet Herit. 2016;39(1):24-29.
5. Romaniuk M, Evans J, Kidd C. Evaluation of an equine-assisted therapy program for veterans who identify as ‘wounded, injured, or ill’ and their partners. PLoS One. 2018;13(9):e0203943.
6. US Department of Veterans Affairs. Frequently asked questions: service animals on VA property. https://www.blogs.va.gov/VAntage/wp-content/uploads/2015/08/FAQs_RegulationsAboutAnimalsonVAProperty.pdf. Published Accessed March 24, 2019.
7. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1188: animals on Veterans Health Administration (VHA) property. https://www.boise.va.gov/docs/Service_Animal_Policy.pdf August 26, 2015.
8. Brulliard K. For military veterans suffering from PTSD, are service dogs good therapy? Washington Post. March 27, 2018.
9. Weinmeyer R. Service dogs for veterans with post-traumatic stress disorder. AMA J Ethics. 2015;17(6):547-552.
10. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Care Services. Guide and service dogs. https://www.prosthetics.va.gov/serviceandguidedogs.asp. Updated August 18, 2016. Accessed March 24, 2019.
11. US Department of Veterans Affairs. VA pilots program to expand veterinary benefits for mental health mobility service dogs. https://www.blogs.va.gov/VAntage/33379/va-pilots-program-to-expand-veterinary-health-benefit-for-mental-health-mobility-service-dogs. Published Accessed March 24, 2019.
12. Yarborough BJH, Stumbo SP, Yarborough MT, Owen-Smith A, Green CA. Benefits and challenges of using service dogs for veterans with posttraumatic stress disorder. Psychiatr Rehabil J. 2018;41(2):118-124.
1. Schweitzer A. Civilization and Ethics. Naish JP, trans. London, England: A. & C. Black; 1923.
2. Bergeron AW Jr. War dogs: the birth of the K-9 Corps. https://www.army.mil/article/7463/war_dogs_the_birth_of_the_k_9_corps. Published February 14, 2008. Accessed March 22, 2019.
3. Nye L. A brief history of dogs in warfare. https://www.military.com/undertheradar/2017/03/brief-history-dogs-warfare. Published March 20, 2017. Accessed March 24, 2019.
4. Liao S. Furry valor: The tactical dogs of WW I and II. Vet Herit. 2016;39(1):24-29.
5. Romaniuk M, Evans J, Kidd C. Evaluation of an equine-assisted therapy program for veterans who identify as ‘wounded, injured, or ill’ and their partners. PLoS One. 2018;13(9):e0203943.
6. US Department of Veterans Affairs. Frequently asked questions: service animals on VA property. https://www.blogs.va.gov/VAntage/wp-content/uploads/2015/08/FAQs_RegulationsAboutAnimalsonVAProperty.pdf. Published Accessed March 24, 2019.
7. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1188: animals on Veterans Health Administration (VHA) property. https://www.boise.va.gov/docs/Service_Animal_Policy.pdf August 26, 2015.
8. Brulliard K. For military veterans suffering from PTSD, are service dogs good therapy? Washington Post. March 27, 2018.
9. Weinmeyer R. Service dogs for veterans with post-traumatic stress disorder. AMA J Ethics. 2015;17(6):547-552.
10. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Care Services. Guide and service dogs. https://www.prosthetics.va.gov/serviceandguidedogs.asp. Updated August 18, 2016. Accessed March 24, 2019.
11. US Department of Veterans Affairs. VA pilots program to expand veterinary benefits for mental health mobility service dogs. https://www.blogs.va.gov/VAntage/33379/va-pilots-program-to-expand-veterinary-health-benefit-for-mental-health-mobility-service-dogs. Published Accessed March 24, 2019.
12. Yarborough BJH, Stumbo SP, Yarborough MT, Owen-Smith A, Green CA. Benefits and challenges of using service dogs for veterans with posttraumatic stress disorder. Psychiatr Rehabil J. 2018;41(2):118-124.
Hair Loss in Skin of Color Patients
What does your patient need to know at the first visit?
All patients, regardless of race, gender, or age, are afraid of an alopecia diagnosis. Often, the first thing a patient may say when I enter the examination room is, "Please don't tell me I have alopecia."
The first step to a successful initial visit for hair loss is addressing the angst around the word alopecia, which helps to manage the patient's hair-induced anxiety. The next priority is setting expectations for the journey including what to expect during the diagnosis process, treatment, and beyond.
Next is data collection. An extensive hair care practice investigation can begin with a survey that the patient fills out before the visit. Dive into and expand on hair loss history questions, including medical history as well as hair care practices (eg, history of use, frequency, number of years, maintenance for that particular hairstyle) such as braids (eg, individual braids, cornrow braids, with or without added synthetic or human hair), locs (eg, length of locs), chemical relaxers (eg, number of years, frequency, professionally applied or applied at home), hair color, weaves (eg, glued in, sewn in, combination), and more.1 Include a family history of hair loss, both maternal and paternal.
The hair loss investigation almost always includes a scalp biopsy, hair-pull test, dermoscopy, photographs, and even blood work, if applicable. Scalp biopsies may reveal more than one type of alopecia diagnosis, which may impact the treatment plan.2 Sending the scalp biopsy specimen to a dermatopathologist specializing in alopecia along with clinical information about the patient is preferred.
What are your go-to treatments?
My go-to treatments for patients with skin of color (SOC) and hair loss really depend on the specific diagnosis. Randomized, placebo-controlled clinical trials focusing on treatment are lacking in central centrifugal cicatricial alopecia and traction alopecia, which holds true for many other types of alopecia.
For black patients with central centrifugal cicatricial alopecia, I often address the inflammatory component of the disease with oral doxycycline and either a topical corticosteroid, such as clobetasol, or intralesional triamcinolone. Adding minoxidil-containing products later in the treatment process can be helpful. Various treatment protocols exist but are mainly based on anecdotal evidence.1
For those with traction alopecia, modification of offending hairstyle practices is a must.3 Also, treatment of inflammation is key. Typically, I gravitate to topical or intralesional corticosteroids, followed by minoxidil-containing products. However, a challenge of treating traction alopecia is changing the hair care practices that cause tight pulling, friction, or pressure on the scalp, such as from the band of a tightly fitted wig.
It is important to discuss potential side effects of any treatment with the patient. For the most common side effects, discuss how to best prevent them. For example, because of the photosensitivity potential of doxycycline, I ask patients to wear sunscreen daily. To prevent nausea, I recommend that they avoid taking doxycycline on an empty stomach, drink plenty of fluids, and avoid laying down within a few hours after taking the medication.
How do you keep patients compliant with treatment?
Dermatologists should try to understand their patients' hair. A study of 200 black women demonstrated that 68% of the patients did not think their physician understood their hair,4 which likely impacts patients' perceptions of their physician, confidence in the treatment plan, and even compliance with the plan. Attempting to understand the nuances of tightly coiled hair in those of African descent is the first step in the journey of diagnosing and treating hair loss in partnership with the patient.
Setting the goal is a crucial step toward patient compliance. It may be going out in public without a wig or weave and feeling confident, providing more coverage so affected areas do not show as much, improving scalp tenderness, and/or preventing further progression of the condition. These are all reasonable outcomes and each goal is uniquely tailored to each patient.
Familiarize yourself with various hair types, hairstyles, and preferred medication vehicles by attending continuing medical education lectures on alopecia in patients with SOC and on nuances to diagnosis and treatment, reading textbooks focusing on SOC, or seeking out mentorship from a dermatologist who is a hair expert in the types of alopecia most commonly affecting patients with SOC.
What resources do you recommend to patients for more information
For patients with scarring alopecia, the Cicatricial Alopecia Research Foundation (http://www.carfintl.org/) is a great resource for medical information and support groups. Also, the Skin of Color Society has dermatology patient education information (http://skinofcolorsociety.org/).
For patients who are extremely distressed by hair loss, I encourage them to see a mental health professional. The mental health impact of alopecia, despite the extent of disease, is likely underestimated. Patients sometimes need our permission to seek help, especially in many SOC communities where even seeking mental health care often is frowned upon.
- Taylor SC, Barbosa V, Burgess C, et al. Hair and scalp disorders in adult and pediatric skin of color patients: bootcamp discussion. Cutis. 2017;100:31-35.
- Wohltmann WE, Sperling L. Histopathologic diagnosis of multifactorial alopecia. J Cutan Pathol. 2016;43:483-491.
- Haskin A, Aguh C. All hairstyles are not created equal: what the dermatologist needs to know about black hairstyling practices and the risk of traction alopecia. J Am Acad Dermatol. 2016;75:606-611.
- Gathers RC, Mahan MG. African American women, hair care and health barriers. J Clin Aesthet Dermatol. 2014;7:26-29.
What does your patient need to know at the first visit?
All patients, regardless of race, gender, or age, are afraid of an alopecia diagnosis. Often, the first thing a patient may say when I enter the examination room is, "Please don't tell me I have alopecia."
The first step to a successful initial visit for hair loss is addressing the angst around the word alopecia, which helps to manage the patient's hair-induced anxiety. The next priority is setting expectations for the journey including what to expect during the diagnosis process, treatment, and beyond.
Next is data collection. An extensive hair care practice investigation can begin with a survey that the patient fills out before the visit. Dive into and expand on hair loss history questions, including medical history as well as hair care practices (eg, history of use, frequency, number of years, maintenance for that particular hairstyle) such as braids (eg, individual braids, cornrow braids, with or without added synthetic or human hair), locs (eg, length of locs), chemical relaxers (eg, number of years, frequency, professionally applied or applied at home), hair color, weaves (eg, glued in, sewn in, combination), and more.1 Include a family history of hair loss, both maternal and paternal.
The hair loss investigation almost always includes a scalp biopsy, hair-pull test, dermoscopy, photographs, and even blood work, if applicable. Scalp biopsies may reveal more than one type of alopecia diagnosis, which may impact the treatment plan.2 Sending the scalp biopsy specimen to a dermatopathologist specializing in alopecia along with clinical information about the patient is preferred.
What are your go-to treatments?
My go-to treatments for patients with skin of color (SOC) and hair loss really depend on the specific diagnosis. Randomized, placebo-controlled clinical trials focusing on treatment are lacking in central centrifugal cicatricial alopecia and traction alopecia, which holds true for many other types of alopecia.
For black patients with central centrifugal cicatricial alopecia, I often address the inflammatory component of the disease with oral doxycycline and either a topical corticosteroid, such as clobetasol, or intralesional triamcinolone. Adding minoxidil-containing products later in the treatment process can be helpful. Various treatment protocols exist but are mainly based on anecdotal evidence.1
For those with traction alopecia, modification of offending hairstyle practices is a must.3 Also, treatment of inflammation is key. Typically, I gravitate to topical or intralesional corticosteroids, followed by minoxidil-containing products. However, a challenge of treating traction alopecia is changing the hair care practices that cause tight pulling, friction, or pressure on the scalp, such as from the band of a tightly fitted wig.
It is important to discuss potential side effects of any treatment with the patient. For the most common side effects, discuss how to best prevent them. For example, because of the photosensitivity potential of doxycycline, I ask patients to wear sunscreen daily. To prevent nausea, I recommend that they avoid taking doxycycline on an empty stomach, drink plenty of fluids, and avoid laying down within a few hours after taking the medication.
How do you keep patients compliant with treatment?
Dermatologists should try to understand their patients' hair. A study of 200 black women demonstrated that 68% of the patients did not think their physician understood their hair,4 which likely impacts patients' perceptions of their physician, confidence in the treatment plan, and even compliance with the plan. Attempting to understand the nuances of tightly coiled hair in those of African descent is the first step in the journey of diagnosing and treating hair loss in partnership with the patient.
Setting the goal is a crucial step toward patient compliance. It may be going out in public without a wig or weave and feeling confident, providing more coverage so affected areas do not show as much, improving scalp tenderness, and/or preventing further progression of the condition. These are all reasonable outcomes and each goal is uniquely tailored to each patient.
Familiarize yourself with various hair types, hairstyles, and preferred medication vehicles by attending continuing medical education lectures on alopecia in patients with SOC and on nuances to diagnosis and treatment, reading textbooks focusing on SOC, or seeking out mentorship from a dermatologist who is a hair expert in the types of alopecia most commonly affecting patients with SOC.
What resources do you recommend to patients for more information
For patients with scarring alopecia, the Cicatricial Alopecia Research Foundation (http://www.carfintl.org/) is a great resource for medical information and support groups. Also, the Skin of Color Society has dermatology patient education information (http://skinofcolorsociety.org/).
For patients who are extremely distressed by hair loss, I encourage them to see a mental health professional. The mental health impact of alopecia, despite the extent of disease, is likely underestimated. Patients sometimes need our permission to seek help, especially in many SOC communities where even seeking mental health care often is frowned upon.
What does your patient need to know at the first visit?
All patients, regardless of race, gender, or age, are afraid of an alopecia diagnosis. Often, the first thing a patient may say when I enter the examination room is, "Please don't tell me I have alopecia."
The first step to a successful initial visit for hair loss is addressing the angst around the word alopecia, which helps to manage the patient's hair-induced anxiety. The next priority is setting expectations for the journey including what to expect during the diagnosis process, treatment, and beyond.
Next is data collection. An extensive hair care practice investigation can begin with a survey that the patient fills out before the visit. Dive into and expand on hair loss history questions, including medical history as well as hair care practices (eg, history of use, frequency, number of years, maintenance for that particular hairstyle) such as braids (eg, individual braids, cornrow braids, with or without added synthetic or human hair), locs (eg, length of locs), chemical relaxers (eg, number of years, frequency, professionally applied or applied at home), hair color, weaves (eg, glued in, sewn in, combination), and more.1 Include a family history of hair loss, both maternal and paternal.
The hair loss investigation almost always includes a scalp biopsy, hair-pull test, dermoscopy, photographs, and even blood work, if applicable. Scalp biopsies may reveal more than one type of alopecia diagnosis, which may impact the treatment plan.2 Sending the scalp biopsy specimen to a dermatopathologist specializing in alopecia along with clinical information about the patient is preferred.
What are your go-to treatments?
My go-to treatments for patients with skin of color (SOC) and hair loss really depend on the specific diagnosis. Randomized, placebo-controlled clinical trials focusing on treatment are lacking in central centrifugal cicatricial alopecia and traction alopecia, which holds true for many other types of alopecia.
For black patients with central centrifugal cicatricial alopecia, I often address the inflammatory component of the disease with oral doxycycline and either a topical corticosteroid, such as clobetasol, or intralesional triamcinolone. Adding minoxidil-containing products later in the treatment process can be helpful. Various treatment protocols exist but are mainly based on anecdotal evidence.1
For those with traction alopecia, modification of offending hairstyle practices is a must.3 Also, treatment of inflammation is key. Typically, I gravitate to topical or intralesional corticosteroids, followed by minoxidil-containing products. However, a challenge of treating traction alopecia is changing the hair care practices that cause tight pulling, friction, or pressure on the scalp, such as from the band of a tightly fitted wig.
It is important to discuss potential side effects of any treatment with the patient. For the most common side effects, discuss how to best prevent them. For example, because of the photosensitivity potential of doxycycline, I ask patients to wear sunscreen daily. To prevent nausea, I recommend that they avoid taking doxycycline on an empty stomach, drink plenty of fluids, and avoid laying down within a few hours after taking the medication.
How do you keep patients compliant with treatment?
Dermatologists should try to understand their patients' hair. A study of 200 black women demonstrated that 68% of the patients did not think their physician understood their hair,4 which likely impacts patients' perceptions of their physician, confidence in the treatment plan, and even compliance with the plan. Attempting to understand the nuances of tightly coiled hair in those of African descent is the first step in the journey of diagnosing and treating hair loss in partnership with the patient.
Setting the goal is a crucial step toward patient compliance. It may be going out in public without a wig or weave and feeling confident, providing more coverage so affected areas do not show as much, improving scalp tenderness, and/or preventing further progression of the condition. These are all reasonable outcomes and each goal is uniquely tailored to each patient.
Familiarize yourself with various hair types, hairstyles, and preferred medication vehicles by attending continuing medical education lectures on alopecia in patients with SOC and on nuances to diagnosis and treatment, reading textbooks focusing on SOC, or seeking out mentorship from a dermatologist who is a hair expert in the types of alopecia most commonly affecting patients with SOC.
What resources do you recommend to patients for more information
For patients with scarring alopecia, the Cicatricial Alopecia Research Foundation (http://www.carfintl.org/) is a great resource for medical information and support groups. Also, the Skin of Color Society has dermatology patient education information (http://skinofcolorsociety.org/).
For patients who are extremely distressed by hair loss, I encourage them to see a mental health professional. The mental health impact of alopecia, despite the extent of disease, is likely underestimated. Patients sometimes need our permission to seek help, especially in many SOC communities where even seeking mental health care often is frowned upon.
- Taylor SC, Barbosa V, Burgess C, et al. Hair and scalp disorders in adult and pediatric skin of color patients: bootcamp discussion. Cutis. 2017;100:31-35.
- Wohltmann WE, Sperling L. Histopathologic diagnosis of multifactorial alopecia. J Cutan Pathol. 2016;43:483-491.
- Haskin A, Aguh C. All hairstyles are not created equal: what the dermatologist needs to know about black hairstyling practices and the risk of traction alopecia. J Am Acad Dermatol. 2016;75:606-611.
- Gathers RC, Mahan MG. African American women, hair care and health barriers. J Clin Aesthet Dermatol. 2014;7:26-29.
- Taylor SC, Barbosa V, Burgess C, et al. Hair and scalp disorders in adult and pediatric skin of color patients: bootcamp discussion. Cutis. 2017;100:31-35.
- Wohltmann WE, Sperling L. Histopathologic diagnosis of multifactorial alopecia. J Cutan Pathol. 2016;43:483-491.
- Haskin A, Aguh C. All hairstyles are not created equal: what the dermatologist needs to know about black hairstyling practices and the risk of traction alopecia. J Am Acad Dermatol. 2016;75:606-611.
- Gathers RC, Mahan MG. African American women, hair care and health barriers. J Clin Aesthet Dermatol. 2014;7:26-29.
Mindfulness yoga reduced stress and motor symptoms in patients with Parkinson’s disease
Among patients with mild or moderate Parkinson’s disease, mindfulness yoga was as effective as stretching and resistance training in improving motor function and mobility, a randomized trial found.
In addition, mindfulness yoga reduced anxiety and depressive symptoms and increased spiritual well-being and health-related quality of life more than stretching and resistance training, researchers reported in JAMA Neurology.
Although guidelines support exercise for patients with Parkinson’s disease, investigators had not examined whether yoga is superior to conventional exercise for stress and symptom management in this patient population. Jojo Y. Y. Kwok, PhD, a research assistant professor of nursing at the University of Hong Kong, and her colleagues conducted an assessor-masked, randomized trial that included 138 adults with idiopathic Parkinson’s disease who were able to stand on their own and walk with or without an assistive device. The trial was conducted at 4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017. Participants were randomized to 8 weeks of mindfulness yoga delivered weekly in 90-minute group sessions (71) or stretching and resistance training delivered in weekly 60-minute group sessions (67).
The primary outcomes was psychological distress in terms of anxiety and depressive symptoms assessed with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes included motor symptom severity, mobility, spiritual well-being in terms of perceived hardship and equanimity, and health-related quality of life. The researchers assessed patients at baseline, 8 weeks, and 20 weeks.
The average age of the participants was 63.7 years; 65 (47.1%) were men. Generalized estimating equation analyses found that patients in the yoga group had significantly better outcomes, including for anxiety (time-by-group interaction, beta, –1.79 at 8 weeks and –2.05 at 20 weeks), and depressive symptoms (beta, –2.75 at 8 weeks and –2.75 at 20 weeks). These improvements were considered “statistically and clinically significant, the authors wrote. There were no significant improvements in anxiety or depressive symptoms in the stretching and resistance training group at the different time points.
Outcomes in the yoga group were also better with regards to disease-specific health-related quality of life (beta, –7.77 at 8 weeks and –7.99 at 20 weeks). Those who were in the mindfulness yoga group also had greater improvements in measures of perceived hardship and equanimity, compared with the stretching and resistance training group.
Referring to the improved psychological outcomes in the yoga group, the authors wrote, “these benefits were remarkable because the participants who received the [mindfulness yoga] intervention attended a mean of only 6 sessions.”
There were significant reductions in motor symptoms in both groups, which were significantly higher among those undergoing stretching, but the differences in the mean scores between the two groups were “clinically insignificant,” they wrote.
Three participants in the yoga group and 2 in the control group reported temporary mild knee pain. No serious adverse events were reported.
Expectation bias, selection bias, and the dropout rates of 15.2% at 8 weeks and 18.8% at 20 weeks are limitations of the study, the authors noted.
“These findings suggest that ,” Dr. Kwok and her colleagues concluded. “Considering that PD is not only a physically limiting condition but also a psychologically distressing life event, health care professionals should adopt a holistic approach in PD rehabilitation. Future rehabilitation programs could consider integrating mindfulness skills into physical therapy to enhance the holistic well-being of people with neurodegenerative conditions.”
The trial was supported by the Professional Development Fund of the Association of Hong Kong Nursing Staff. The authors had no disclosures.
SOURCE: Kwok JYY et al. JAMA Neurol. 2019 Apr 8. doi: 10.1001/jamaneurol.2019.0534.
Among patients with mild or moderate Parkinson’s disease, mindfulness yoga was as effective as stretching and resistance training in improving motor function and mobility, a randomized trial found.
In addition, mindfulness yoga reduced anxiety and depressive symptoms and increased spiritual well-being and health-related quality of life more than stretching and resistance training, researchers reported in JAMA Neurology.
Although guidelines support exercise for patients with Parkinson’s disease, investigators had not examined whether yoga is superior to conventional exercise for stress and symptom management in this patient population. Jojo Y. Y. Kwok, PhD, a research assistant professor of nursing at the University of Hong Kong, and her colleagues conducted an assessor-masked, randomized trial that included 138 adults with idiopathic Parkinson’s disease who were able to stand on their own and walk with or without an assistive device. The trial was conducted at 4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017. Participants were randomized to 8 weeks of mindfulness yoga delivered weekly in 90-minute group sessions (71) or stretching and resistance training delivered in weekly 60-minute group sessions (67).
The primary outcomes was psychological distress in terms of anxiety and depressive symptoms assessed with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes included motor symptom severity, mobility, spiritual well-being in terms of perceived hardship and equanimity, and health-related quality of life. The researchers assessed patients at baseline, 8 weeks, and 20 weeks.
The average age of the participants was 63.7 years; 65 (47.1%) were men. Generalized estimating equation analyses found that patients in the yoga group had significantly better outcomes, including for anxiety (time-by-group interaction, beta, –1.79 at 8 weeks and –2.05 at 20 weeks), and depressive symptoms (beta, –2.75 at 8 weeks and –2.75 at 20 weeks). These improvements were considered “statistically and clinically significant, the authors wrote. There were no significant improvements in anxiety or depressive symptoms in the stretching and resistance training group at the different time points.
Outcomes in the yoga group were also better with regards to disease-specific health-related quality of life (beta, –7.77 at 8 weeks and –7.99 at 20 weeks). Those who were in the mindfulness yoga group also had greater improvements in measures of perceived hardship and equanimity, compared with the stretching and resistance training group.
Referring to the improved psychological outcomes in the yoga group, the authors wrote, “these benefits were remarkable because the participants who received the [mindfulness yoga] intervention attended a mean of only 6 sessions.”
There were significant reductions in motor symptoms in both groups, which were significantly higher among those undergoing stretching, but the differences in the mean scores between the two groups were “clinically insignificant,” they wrote.
Three participants in the yoga group and 2 in the control group reported temporary mild knee pain. No serious adverse events were reported.
Expectation bias, selection bias, and the dropout rates of 15.2% at 8 weeks and 18.8% at 20 weeks are limitations of the study, the authors noted.
“These findings suggest that ,” Dr. Kwok and her colleagues concluded. “Considering that PD is not only a physically limiting condition but also a psychologically distressing life event, health care professionals should adopt a holistic approach in PD rehabilitation. Future rehabilitation programs could consider integrating mindfulness skills into physical therapy to enhance the holistic well-being of people with neurodegenerative conditions.”
The trial was supported by the Professional Development Fund of the Association of Hong Kong Nursing Staff. The authors had no disclosures.
SOURCE: Kwok JYY et al. JAMA Neurol. 2019 Apr 8. doi: 10.1001/jamaneurol.2019.0534.
Among patients with mild or moderate Parkinson’s disease, mindfulness yoga was as effective as stretching and resistance training in improving motor function and mobility, a randomized trial found.
In addition, mindfulness yoga reduced anxiety and depressive symptoms and increased spiritual well-being and health-related quality of life more than stretching and resistance training, researchers reported in JAMA Neurology.
Although guidelines support exercise for patients with Parkinson’s disease, investigators had not examined whether yoga is superior to conventional exercise for stress and symptom management in this patient population. Jojo Y. Y. Kwok, PhD, a research assistant professor of nursing at the University of Hong Kong, and her colleagues conducted an assessor-masked, randomized trial that included 138 adults with idiopathic Parkinson’s disease who were able to stand on their own and walk with or without an assistive device. The trial was conducted at 4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017. Participants were randomized to 8 weeks of mindfulness yoga delivered weekly in 90-minute group sessions (71) or stretching and resistance training delivered in weekly 60-minute group sessions (67).
The primary outcomes was psychological distress in terms of anxiety and depressive symptoms assessed with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes included motor symptom severity, mobility, spiritual well-being in terms of perceived hardship and equanimity, and health-related quality of life. The researchers assessed patients at baseline, 8 weeks, and 20 weeks.
The average age of the participants was 63.7 years; 65 (47.1%) were men. Generalized estimating equation analyses found that patients in the yoga group had significantly better outcomes, including for anxiety (time-by-group interaction, beta, –1.79 at 8 weeks and –2.05 at 20 weeks), and depressive symptoms (beta, –2.75 at 8 weeks and –2.75 at 20 weeks). These improvements were considered “statistically and clinically significant, the authors wrote. There were no significant improvements in anxiety or depressive symptoms in the stretching and resistance training group at the different time points.
Outcomes in the yoga group were also better with regards to disease-specific health-related quality of life (beta, –7.77 at 8 weeks and –7.99 at 20 weeks). Those who were in the mindfulness yoga group also had greater improvements in measures of perceived hardship and equanimity, compared with the stretching and resistance training group.
Referring to the improved psychological outcomes in the yoga group, the authors wrote, “these benefits were remarkable because the participants who received the [mindfulness yoga] intervention attended a mean of only 6 sessions.”
There were significant reductions in motor symptoms in both groups, which were significantly higher among those undergoing stretching, but the differences in the mean scores between the two groups were “clinically insignificant,” they wrote.
Three participants in the yoga group and 2 in the control group reported temporary mild knee pain. No serious adverse events were reported.
Expectation bias, selection bias, and the dropout rates of 15.2% at 8 weeks and 18.8% at 20 weeks are limitations of the study, the authors noted.
“These findings suggest that ,” Dr. Kwok and her colleagues concluded. “Considering that PD is not only a physically limiting condition but also a psychologically distressing life event, health care professionals should adopt a holistic approach in PD rehabilitation. Future rehabilitation programs could consider integrating mindfulness skills into physical therapy to enhance the holistic well-being of people with neurodegenerative conditions.”
The trial was supported by the Professional Development Fund of the Association of Hong Kong Nursing Staff. The authors had no disclosures.
SOURCE: Kwok JYY et al. JAMA Neurol. 2019 Apr 8. doi: 10.1001/jamaneurol.2019.0534.
FROM JAMA NEUROLOGY
How common are noninfectious complications of Foley catheters?
CLINICAL QUESTION: How common are noninfectious complications of Foley catheters?
BACKGROUND: Approximately 20% of hospitalized patients have a Foley catheter inserted at some time during their admission. Infectious complications associated with the use of Foley catheters are widely recognized; however, much less is known about noninfectious complications.
STUDY DESIGN: Prospective cohort study.
SETTING: Four U.S. hospitals in two states.SYNOPSIS: The study included 2,076 hospitalized patients with a Foley catheter. They were followed for 30 days after its insertion, even if catheter removal occurred during this time period. Data about infectious and noninfectious complications were collected through patient interviews.
At least one complication was noted in 1,184 of 2,076 patients (57%) during the 30-day period following Foley catheter insertion. While infectious complications occurred in 219 of 2,076 patients (10.5%), noninfectious complications (such as pain, urinary urgency, hematuria) were reported by 1,150 patients (55.4%; P less than .001). For those with catheters still in place, the most common complication was pain or discomfort (54.5%). Postremoval leaking urine (20.3%) and/or urgency and bladder spasms (24.0%) were the most common complications.
The study only included patients who had a Foley catheter placed during a hospitalization; the results may not apply to patients who receive catheters in other settings.
BOTTOM LINE: Noninfectious complications affect over half of patients with a Foley catheters. These types of complications should be targeted in future harm prevention efforts and should be considered when deciding to place a Foley catheter.
CITATION: Saint S et al. A multicenter study of patient-reported infectious and noninfectious complications associated with indwelling urethral catheters. JAMA Intern Med. 2018;178(8):1078-85.
Dr. Clarke is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.
CLINICAL QUESTION: How common are noninfectious complications of Foley catheters?
BACKGROUND: Approximately 20% of hospitalized patients have a Foley catheter inserted at some time during their admission. Infectious complications associated with the use of Foley catheters are widely recognized; however, much less is known about noninfectious complications.
STUDY DESIGN: Prospective cohort study.
SETTING: Four U.S. hospitals in two states.SYNOPSIS: The study included 2,076 hospitalized patients with a Foley catheter. They were followed for 30 days after its insertion, even if catheter removal occurred during this time period. Data about infectious and noninfectious complications were collected through patient interviews.
At least one complication was noted in 1,184 of 2,076 patients (57%) during the 30-day period following Foley catheter insertion. While infectious complications occurred in 219 of 2,076 patients (10.5%), noninfectious complications (such as pain, urinary urgency, hematuria) were reported by 1,150 patients (55.4%; P less than .001). For those with catheters still in place, the most common complication was pain or discomfort (54.5%). Postremoval leaking urine (20.3%) and/or urgency and bladder spasms (24.0%) were the most common complications.
The study only included patients who had a Foley catheter placed during a hospitalization; the results may not apply to patients who receive catheters in other settings.
BOTTOM LINE: Noninfectious complications affect over half of patients with a Foley catheters. These types of complications should be targeted in future harm prevention efforts and should be considered when deciding to place a Foley catheter.
CITATION: Saint S et al. A multicenter study of patient-reported infectious and noninfectious complications associated with indwelling urethral catheters. JAMA Intern Med. 2018;178(8):1078-85.
Dr. Clarke is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.
CLINICAL QUESTION: How common are noninfectious complications of Foley catheters?
BACKGROUND: Approximately 20% of hospitalized patients have a Foley catheter inserted at some time during their admission. Infectious complications associated with the use of Foley catheters are widely recognized; however, much less is known about noninfectious complications.
STUDY DESIGN: Prospective cohort study.
SETTING: Four U.S. hospitals in two states.SYNOPSIS: The study included 2,076 hospitalized patients with a Foley catheter. They were followed for 30 days after its insertion, even if catheter removal occurred during this time period. Data about infectious and noninfectious complications were collected through patient interviews.
At least one complication was noted in 1,184 of 2,076 patients (57%) during the 30-day period following Foley catheter insertion. While infectious complications occurred in 219 of 2,076 patients (10.5%), noninfectious complications (such as pain, urinary urgency, hematuria) were reported by 1,150 patients (55.4%; P less than .001). For those with catheters still in place, the most common complication was pain or discomfort (54.5%). Postremoval leaking urine (20.3%) and/or urgency and bladder spasms (24.0%) were the most common complications.
The study only included patients who had a Foley catheter placed during a hospitalization; the results may not apply to patients who receive catheters in other settings.
BOTTOM LINE: Noninfectious complications affect over half of patients with a Foley catheters. These types of complications should be targeted in future harm prevention efforts and should be considered when deciding to place a Foley catheter.
CITATION: Saint S et al. A multicenter study of patient-reported infectious and noninfectious complications associated with indwelling urethral catheters. JAMA Intern Med. 2018;178(8):1078-85.
Dr. Clarke is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.
Robotics will expand endoscopy’s vision and reach
Think about what a puppet can do: Not much, since it’s typically controlled by a single hand. Then consider the skills of a marionette in the hands – both of them – of a talented performer: It can gesture and jump and even dance. A whole new world of movement opens up thanks to the capacity for fine-tuned control.
When it comes to GI endoscopy, revolutionary two-handed marionette-style control beckons on the horizon thanks to robotics. That’s the word from Josh DeFonzo, chief operating officer of Auris Health, who will present a keynote speech on “Opportunities in GI Over the Next Decade” at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“I’ll be talking about where opportunities will lie in the GI space over the next decade,” Mr. DeFonzo said. “One of the major themes will be the need to accelerate technical capabilities in endoscopy. Noninvasive treatment is quite challenging for interventional endoscopists. They generally don’t have the tools they need to reach where they need to reach, see where they need to see, and perform complex tasks, at least not at scale.”
This is all changing thanks to the work of companies like Auris Health, which is working to advance endoscopy through flexible robotics. Auris Health, which was recently acquired by Johnson & Johnson, is offering robotic endoscopy to pulmonologists and developing it for gastroenterology.
The challenges of existing endoscopic technology, Mr. DeFonzo said, revolve around the limitations of access. “In the world of GI, it’s not difficult to get to polyps or cancerous lesions. It’s harder to do something when you’re there,” he said. “In the colon, stomach, and esophagus, you’re in a cylindrical hallway with a cylindrical device, and both are moving. You don’t have the stability to achieve traction, and you are usually limited to a single hand and single working channel.”
Robotic endoscopic technology offers physicians the ability to overcome these barriers through two-handed control and other advances. “It’s all about reach, vision, control, and the ability to perform tasks as a result of those three things,” he said. “The hope is empower endoscopists with more tools and capabilities to prevent patients from having to undergo surgery.”
Within the next 5 years, he predicts, physicians will be able to use robotic endoscopy to remove potentially cancerous lesions during colonoscopy instead of referring patients for colectomy. And over the longer term, perhaps over more than a decade, he expects patients will be able to undergo endoscopic removal of those lesions during colonoscopy instead of being referred.
Meanwhile, he said, scientists are advancing areas such as two-handed robotic control, Google Maps-style navigation based on preoperative scans, and pattern recognition to detect abnormalities such as lesions.
Think about what a puppet can do: Not much, since it’s typically controlled by a single hand. Then consider the skills of a marionette in the hands – both of them – of a talented performer: It can gesture and jump and even dance. A whole new world of movement opens up thanks to the capacity for fine-tuned control.
When it comes to GI endoscopy, revolutionary two-handed marionette-style control beckons on the horizon thanks to robotics. That’s the word from Josh DeFonzo, chief operating officer of Auris Health, who will present a keynote speech on “Opportunities in GI Over the Next Decade” at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“I’ll be talking about where opportunities will lie in the GI space over the next decade,” Mr. DeFonzo said. “One of the major themes will be the need to accelerate technical capabilities in endoscopy. Noninvasive treatment is quite challenging for interventional endoscopists. They generally don’t have the tools they need to reach where they need to reach, see where they need to see, and perform complex tasks, at least not at scale.”
This is all changing thanks to the work of companies like Auris Health, which is working to advance endoscopy through flexible robotics. Auris Health, which was recently acquired by Johnson & Johnson, is offering robotic endoscopy to pulmonologists and developing it for gastroenterology.
The challenges of existing endoscopic technology, Mr. DeFonzo said, revolve around the limitations of access. “In the world of GI, it’s not difficult to get to polyps or cancerous lesions. It’s harder to do something when you’re there,” he said. “In the colon, stomach, and esophagus, you’re in a cylindrical hallway with a cylindrical device, and both are moving. You don’t have the stability to achieve traction, and you are usually limited to a single hand and single working channel.”
Robotic endoscopic technology offers physicians the ability to overcome these barriers through two-handed control and other advances. “It’s all about reach, vision, control, and the ability to perform tasks as a result of those three things,” he said. “The hope is empower endoscopists with more tools and capabilities to prevent patients from having to undergo surgery.”
Within the next 5 years, he predicts, physicians will be able to use robotic endoscopy to remove potentially cancerous lesions during colonoscopy instead of referring patients for colectomy. And over the longer term, perhaps over more than a decade, he expects patients will be able to undergo endoscopic removal of those lesions during colonoscopy instead of being referred.
Meanwhile, he said, scientists are advancing areas such as two-handed robotic control, Google Maps-style navigation based on preoperative scans, and pattern recognition to detect abnormalities such as lesions.
Think about what a puppet can do: Not much, since it’s typically controlled by a single hand. Then consider the skills of a marionette in the hands – both of them – of a talented performer: It can gesture and jump and even dance. A whole new world of movement opens up thanks to the capacity for fine-tuned control.
When it comes to GI endoscopy, revolutionary two-handed marionette-style control beckons on the horizon thanks to robotics. That’s the word from Josh DeFonzo, chief operating officer of Auris Health, who will present a keynote speech on “Opportunities in GI Over the Next Decade” at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“I’ll be talking about where opportunities will lie in the GI space over the next decade,” Mr. DeFonzo said. “One of the major themes will be the need to accelerate technical capabilities in endoscopy. Noninvasive treatment is quite challenging for interventional endoscopists. They generally don’t have the tools they need to reach where they need to reach, see where they need to see, and perform complex tasks, at least not at scale.”
This is all changing thanks to the work of companies like Auris Health, which is working to advance endoscopy through flexible robotics. Auris Health, which was recently acquired by Johnson & Johnson, is offering robotic endoscopy to pulmonologists and developing it for gastroenterology.
The challenges of existing endoscopic technology, Mr. DeFonzo said, revolve around the limitations of access. “In the world of GI, it’s not difficult to get to polyps or cancerous lesions. It’s harder to do something when you’re there,” he said. “In the colon, stomach, and esophagus, you’re in a cylindrical hallway with a cylindrical device, and both are moving. You don’t have the stability to achieve traction, and you are usually limited to a single hand and single working channel.”
Robotic endoscopic technology offers physicians the ability to overcome these barriers through two-handed control and other advances. “It’s all about reach, vision, control, and the ability to perform tasks as a result of those three things,” he said. “The hope is empower endoscopists with more tools and capabilities to prevent patients from having to undergo surgery.”
Within the next 5 years, he predicts, physicians will be able to use robotic endoscopy to remove potentially cancerous lesions during colonoscopy instead of referring patients for colectomy. And over the longer term, perhaps over more than a decade, he expects patients will be able to undergo endoscopic removal of those lesions during colonoscopy instead of being referred.
Meanwhile, he said, scientists are advancing areas such as two-handed robotic control, Google Maps-style navigation based on preoperative scans, and pattern recognition to detect abnormalities such as lesions.
FROM THE 2019 AGA TECH SUMMIT
Apply for the Community Awareness and Prevention Grant
The application deadline for the Community Awareness and Prevention Project Grant is April 15. This award is intended to help vascular surgeons conduct community-based projects that address emerging issues in vascular health, wellness and disease prevention. The SVS Foundation encourages applicants to establish collaborative community partnerships with organizations who share our goals for maximizing public health and can contribute to the success of the project. Read more about the grant here.
The application deadline for the Community Awareness and Prevention Project Grant is April 15. This award is intended to help vascular surgeons conduct community-based projects that address emerging issues in vascular health, wellness and disease prevention. The SVS Foundation encourages applicants to establish collaborative community partnerships with organizations who share our goals for maximizing public health and can contribute to the success of the project. Read more about the grant here.
The application deadline for the Community Awareness and Prevention Project Grant is April 15. This award is intended to help vascular surgeons conduct community-based projects that address emerging issues in vascular health, wellness and disease prevention. The SVS Foundation encourages applicants to establish collaborative community partnerships with organizations who share our goals for maximizing public health and can contribute to the success of the project. Read more about the grant here.
VAM Online Planner Available Now
Begin planning your Vascular Annual Meeting experience with the SVS Online Planner. This includes the entire VAM schedule, plus the schedule for the Society for Vascular Nursing’s annual conference. The full schedule for the Vascular Quality Initiative's meeting, VQI@VAM, also will be available in the future. Users can easily find such information as presenters, certain topics, session types, intended audience and credit availability. Find the online planner on the VAM site here.
Begin planning your Vascular Annual Meeting experience with the SVS Online Planner. This includes the entire VAM schedule, plus the schedule for the Society for Vascular Nursing’s annual conference. The full schedule for the Vascular Quality Initiative's meeting, VQI@VAM, also will be available in the future. Users can easily find such information as presenters, certain topics, session types, intended audience and credit availability. Find the online planner on the VAM site here.
Begin planning your Vascular Annual Meeting experience with the SVS Online Planner. This includes the entire VAM schedule, plus the schedule for the Society for Vascular Nursing’s annual conference. The full schedule for the Vascular Quality Initiative's meeting, VQI@VAM, also will be available in the future. Users can easily find such information as presenters, certain topics, session types, intended audience and credit availability. Find the online planner on the VAM site here.
Bronchiolitis is a feared complication of connective tissue disease
MAUI, HAWAII – who develop shortness of breath and cough or a precipitous drop in their forced expiratory volume on pulmonary function testing, Aryeh Fischer, MD, said at the 2019 Rheumatology Winter Clinical Symposium.
“This is an underappreciated – and I think among the most potentially devastating – of the lung diseases we as rheumatologists will encounter in our patients,” said Dr. Fischer, a rheumatologist at the University of Colorado at Denver, Aurora, with a special interest in autoimmune lung disease.
“If you’re seeing patients with rheumatoid arthritis, SLE, or Sjögren’s and they’ve got bad asthma they can’t get under control, you’ve got to think about bronchiolitis because I can tell you your lung doc quite often is not thinking about this,” he added.
Bronchiolitis involves inflammation, narrowing, or obliteration of the small airways. The diagnosis is often missed because of the false sense of reassurance provided by the normal chest x-ray and regular CT findings, which are a feature of the disease.
“This is really important: You have to get a high-resolution CT that includes expiratory images, because that’s the only way you’re going to be able to tell if your patient has small airways disease,” he explained. “You must, must, must do an expiratory CT.”
A normal expiratory CT image should be gray, since the lungs are empty. Air is black on CT, so large areas of black intermixed with gray on an expiratory CT – a finding known as mosaicism – indicate air trapping due to small airways disease, Dr. Fischer noted.
Surgical lung biopsy will yield a pathologic report documenting isolated constrictive, follicular, and/or lymphocytic bronchiolitis. However, the terminology can be confusing: What pathologists describe as constrictive bronchiolitis is called obliterative by pulmonologists and radiologists.
Pulmonary function testing shows an obstructive defect. The diffusing capacity of the lungs for carbon monoxide (DLCO) is fairly normal, the forced expiratory volume in 1 second (FEV1) is sharply reduced, and the forced vital capacity (FVC) is near normal, with a resultant abnormally low FEV1/FVC ratio. A patient with bronchiolitis may or may not have a response to bronchodilators.
“I tell you, I’ve seen a bunch of these patients. They typically have a precipitous drop in their FEV1 and then stay stable at a very low level of lung function without much opportunity for improvement,” Dr. Fischer said. “Stability equals success in these patients. It’s really unusual to see much improvement.”
In theory, patients with follicular or lymphocytic bronchiolitis have an ongoing inflammatory process that should be amenable to rheumatologic ministrations. But there is no convincing evidence of treatment efficacy to date. And in obliterative bronchiolitis, marked by airway scarring, there is no reason to think anti-inflammatory therapies should be helpful. Anecdotally, Dr. Fischer said, he has seen immunosuppression help patients with obliterative bronchiolitis.
“Actually, the only proven therapy is lung transplantation,” he said.
He recommended that his fellow rheumatologists periodically use office spirometry to check the FEV1 in their patients with rheumatoid arthritis, Sjögren’s, or SLE, the forms of connective tissue disease most often associated with bronchiolitis. Compared with all the other testing rheumatologists routinely order in their patients, having them blow into a tube is a simple enough matter.
“We really don’t have anything to impact the natural history, but I like the notion of not being surprised. What are you going to do with that [abnormal] FEV1 data? I have no idea. But maybe it’s better to know earlier,” he said.
Dr. Fischer reported having no financial conflicts of interest regarding his presentation.
MAUI, HAWAII – who develop shortness of breath and cough or a precipitous drop in their forced expiratory volume on pulmonary function testing, Aryeh Fischer, MD, said at the 2019 Rheumatology Winter Clinical Symposium.
“This is an underappreciated – and I think among the most potentially devastating – of the lung diseases we as rheumatologists will encounter in our patients,” said Dr. Fischer, a rheumatologist at the University of Colorado at Denver, Aurora, with a special interest in autoimmune lung disease.
“If you’re seeing patients with rheumatoid arthritis, SLE, or Sjögren’s and they’ve got bad asthma they can’t get under control, you’ve got to think about bronchiolitis because I can tell you your lung doc quite often is not thinking about this,” he added.
Bronchiolitis involves inflammation, narrowing, or obliteration of the small airways. The diagnosis is often missed because of the false sense of reassurance provided by the normal chest x-ray and regular CT findings, which are a feature of the disease.
“This is really important: You have to get a high-resolution CT that includes expiratory images, because that’s the only way you’re going to be able to tell if your patient has small airways disease,” he explained. “You must, must, must do an expiratory CT.”
A normal expiratory CT image should be gray, since the lungs are empty. Air is black on CT, so large areas of black intermixed with gray on an expiratory CT – a finding known as mosaicism – indicate air trapping due to small airways disease, Dr. Fischer noted.
Surgical lung biopsy will yield a pathologic report documenting isolated constrictive, follicular, and/or lymphocytic bronchiolitis. However, the terminology can be confusing: What pathologists describe as constrictive bronchiolitis is called obliterative by pulmonologists and radiologists.
Pulmonary function testing shows an obstructive defect. The diffusing capacity of the lungs for carbon monoxide (DLCO) is fairly normal, the forced expiratory volume in 1 second (FEV1) is sharply reduced, and the forced vital capacity (FVC) is near normal, with a resultant abnormally low FEV1/FVC ratio. A patient with bronchiolitis may or may not have a response to bronchodilators.
“I tell you, I’ve seen a bunch of these patients. They typically have a precipitous drop in their FEV1 and then stay stable at a very low level of lung function without much opportunity for improvement,” Dr. Fischer said. “Stability equals success in these patients. It’s really unusual to see much improvement.”
In theory, patients with follicular or lymphocytic bronchiolitis have an ongoing inflammatory process that should be amenable to rheumatologic ministrations. But there is no convincing evidence of treatment efficacy to date. And in obliterative bronchiolitis, marked by airway scarring, there is no reason to think anti-inflammatory therapies should be helpful. Anecdotally, Dr. Fischer said, he has seen immunosuppression help patients with obliterative bronchiolitis.
“Actually, the only proven therapy is lung transplantation,” he said.
He recommended that his fellow rheumatologists periodically use office spirometry to check the FEV1 in their patients with rheumatoid arthritis, Sjögren’s, or SLE, the forms of connective tissue disease most often associated with bronchiolitis. Compared with all the other testing rheumatologists routinely order in their patients, having them blow into a tube is a simple enough matter.
“We really don’t have anything to impact the natural history, but I like the notion of not being surprised. What are you going to do with that [abnormal] FEV1 data? I have no idea. But maybe it’s better to know earlier,” he said.
Dr. Fischer reported having no financial conflicts of interest regarding his presentation.
MAUI, HAWAII – who develop shortness of breath and cough or a precipitous drop in their forced expiratory volume on pulmonary function testing, Aryeh Fischer, MD, said at the 2019 Rheumatology Winter Clinical Symposium.
“This is an underappreciated – and I think among the most potentially devastating – of the lung diseases we as rheumatologists will encounter in our patients,” said Dr. Fischer, a rheumatologist at the University of Colorado at Denver, Aurora, with a special interest in autoimmune lung disease.
“If you’re seeing patients with rheumatoid arthritis, SLE, or Sjögren’s and they’ve got bad asthma they can’t get under control, you’ve got to think about bronchiolitis because I can tell you your lung doc quite often is not thinking about this,” he added.
Bronchiolitis involves inflammation, narrowing, or obliteration of the small airways. The diagnosis is often missed because of the false sense of reassurance provided by the normal chest x-ray and regular CT findings, which are a feature of the disease.
“This is really important: You have to get a high-resolution CT that includes expiratory images, because that’s the only way you’re going to be able to tell if your patient has small airways disease,” he explained. “You must, must, must do an expiratory CT.”
A normal expiratory CT image should be gray, since the lungs are empty. Air is black on CT, so large areas of black intermixed with gray on an expiratory CT – a finding known as mosaicism – indicate air trapping due to small airways disease, Dr. Fischer noted.
Surgical lung biopsy will yield a pathologic report documenting isolated constrictive, follicular, and/or lymphocytic bronchiolitis. However, the terminology can be confusing: What pathologists describe as constrictive bronchiolitis is called obliterative by pulmonologists and radiologists.
Pulmonary function testing shows an obstructive defect. The diffusing capacity of the lungs for carbon monoxide (DLCO) is fairly normal, the forced expiratory volume in 1 second (FEV1) is sharply reduced, and the forced vital capacity (FVC) is near normal, with a resultant abnormally low FEV1/FVC ratio. A patient with bronchiolitis may or may not have a response to bronchodilators.
“I tell you, I’ve seen a bunch of these patients. They typically have a precipitous drop in their FEV1 and then stay stable at a very low level of lung function without much opportunity for improvement,” Dr. Fischer said. “Stability equals success in these patients. It’s really unusual to see much improvement.”
In theory, patients with follicular or lymphocytic bronchiolitis have an ongoing inflammatory process that should be amenable to rheumatologic ministrations. But there is no convincing evidence of treatment efficacy to date. And in obliterative bronchiolitis, marked by airway scarring, there is no reason to think anti-inflammatory therapies should be helpful. Anecdotally, Dr. Fischer said, he has seen immunosuppression help patients with obliterative bronchiolitis.
“Actually, the only proven therapy is lung transplantation,” he said.
He recommended that his fellow rheumatologists periodically use office spirometry to check the FEV1 in their patients with rheumatoid arthritis, Sjögren’s, or SLE, the forms of connective tissue disease most often associated with bronchiolitis. Compared with all the other testing rheumatologists routinely order in their patients, having them blow into a tube is a simple enough matter.
“We really don’t have anything to impact the natural history, but I like the notion of not being surprised. What are you going to do with that [abnormal] FEV1 data? I have no idea. But maybe it’s better to know earlier,” he said.
Dr. Fischer reported having no financial conflicts of interest regarding his presentation.
REPORTING FROM RWCS 2019