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FDA: Cell phones still look safe
according to a review by the Food and Drug Administration.
The FDA reviewed the published literature from 2008 to 2018 and concluded that the data don’t support any quantifiable adverse health risks from RFR. However, the evidence is not without limitations.
The FDA’s evaluation included evidence from in vivo animal studies from Jan. 1, 2008, to Aug. 1, 2018, and epidemiologic studies in humans from Jan. 1, 2008, to May 8, 2018. Both kinds of evidence had limitations, but neither produced strong indications of any causal risks from cell phone use.
The FDA noted that in vivo animal studies are limited by variability of methods and RFR exposure, which make comparisons of results difficult. These studies are also impacted by the indirect effects of temperature increases (the only currently established biological effect of RFR) and stress experienced by the animals, which make teasing out the direct effects of RFR difficult.
The FDA noted that strong epidemiologic studies can provide more relevant and accurate information than in vivo studies, but epidemiologic studies are not without limitations. For example, most have participants track and self-report their cell phone use. There’s also no way to directly track certain factors of RFR exposure, such as frequency, duration, or intensity.
Even with those caveats in mind, the FDA wrote that, “based on the studies that are described in detail in this report, there is insufficient evidence to support a causal association between RFR exposure and tumorigenesis. There is a lack of clear dose-response relationship, a lack of consistent findings or specificity, and a lack of biological mechanistic plausibility.”
The full review is available on the FDA website.
according to a review by the Food and Drug Administration.
The FDA reviewed the published literature from 2008 to 2018 and concluded that the data don’t support any quantifiable adverse health risks from RFR. However, the evidence is not without limitations.
The FDA’s evaluation included evidence from in vivo animal studies from Jan. 1, 2008, to Aug. 1, 2018, and epidemiologic studies in humans from Jan. 1, 2008, to May 8, 2018. Both kinds of evidence had limitations, but neither produced strong indications of any causal risks from cell phone use.
The FDA noted that in vivo animal studies are limited by variability of methods and RFR exposure, which make comparisons of results difficult. These studies are also impacted by the indirect effects of temperature increases (the only currently established biological effect of RFR) and stress experienced by the animals, which make teasing out the direct effects of RFR difficult.
The FDA noted that strong epidemiologic studies can provide more relevant and accurate information than in vivo studies, but epidemiologic studies are not without limitations. For example, most have participants track and self-report their cell phone use. There’s also no way to directly track certain factors of RFR exposure, such as frequency, duration, or intensity.
Even with those caveats in mind, the FDA wrote that, “based on the studies that are described in detail in this report, there is insufficient evidence to support a causal association between RFR exposure and tumorigenesis. There is a lack of clear dose-response relationship, a lack of consistent findings or specificity, and a lack of biological mechanistic plausibility.”
The full review is available on the FDA website.
according to a review by the Food and Drug Administration.
The FDA reviewed the published literature from 2008 to 2018 and concluded that the data don’t support any quantifiable adverse health risks from RFR. However, the evidence is not without limitations.
The FDA’s evaluation included evidence from in vivo animal studies from Jan. 1, 2008, to Aug. 1, 2018, and epidemiologic studies in humans from Jan. 1, 2008, to May 8, 2018. Both kinds of evidence had limitations, but neither produced strong indications of any causal risks from cell phone use.
The FDA noted that in vivo animal studies are limited by variability of methods and RFR exposure, which make comparisons of results difficult. These studies are also impacted by the indirect effects of temperature increases (the only currently established biological effect of RFR) and stress experienced by the animals, which make teasing out the direct effects of RFR difficult.
The FDA noted that strong epidemiologic studies can provide more relevant and accurate information than in vivo studies, but epidemiologic studies are not without limitations. For example, most have participants track and self-report their cell phone use. There’s also no way to directly track certain factors of RFR exposure, such as frequency, duration, or intensity.
Even with those caveats in mind, the FDA wrote that, “based on the studies that are described in detail in this report, there is insufficient evidence to support a causal association between RFR exposure and tumorigenesis. There is a lack of clear dose-response relationship, a lack of consistent findings or specificity, and a lack of biological mechanistic plausibility.”
The full review is available on the FDA website.
Antineutrophil Cytoplasmic Antibody Vasculitis Induced by Hydralazine
To the Editor:
Hydralazine-induced antineutrophil cytoplasmic antibody vasculitis (HIAV) is a rare side effect that may develop in patients treated with hydralazine. Without early recognition and hydralazine cessation, patients often develop acute renal failure and pulmonary hemorrhage that may result in death. We present a case of HIAV.
A 67-year-old woman presented with progressive, tense, hemorrhagic, and necrotic bullae on both sides of the face and neck as well as the extremities of 2 weeks’ duration. She had a history of hypertension and a thyroid nodule after unilateral thyroid lobectomy. A review of symptoms was positive for worsening dyspnea and progressive generalized weakness. Noteworthy medications included amlodipine, metoprolol, levothyroxine, and oral hydralazine 75 mg 3 times daily for 13 months.
Bullae first appeared on the patient’s scalp and quickly progressed with a cephalocaudal pattern with a propensity for the eyes, nostrils, and labial mucosa (Figure 1). The tongue was covered by an eschar, and she had diffuse periorbital edema. Additionally, concentric purpuric patches were noted on the thighs and lower legs (Figure 2).
Pertinent laboratory findings included a positive antinuclear antibody titer of 1:320 and perinuclear antineutrophil cytoplasmic antibody (ANCA) titer of 1:160, along with an elevated serum creatinine level (2.31 mg/dL [reference range, 0.6–1.2 mg/dL]). Bilateral perihilar infiltrates with bilateral pleural effusions were noted on a chest radiograph.
While hospitalized, she developed pulmonary hemorrhages and a progressive decline in respiratory status. She subsequently was admitted to the medical intensive care unit. Aggressive support was administered, and several skin biopsy specimens were obtained along with an endobronchial biopsy of the right middle lobe.
Skin histopathology revealed a necrotic vasculitis (Figure 3). Direct immunofluorescence was not performed. Lung histopathology showed fragments of bronchial tissue with acute and chronic inflammation, focal necrosis, granulation tissue formation, edema, and squamous metaplasia. Together with the clinical history, these findings were consistent with HIAV.
Hydralazine was immediately discontinued, and the patient was started on 65 mg daily of intravenous methylprednisolone; methylprednisolone was later changed to oral prednisone 30 mg daily. Due to multiple organ involvement—lung and kidney—intravenous rituximab 375 mg/m2 every week for 4 weeks, per lymphoma protocol, was started. Within 2 weeks of beginning therapy, her renal function and respiratory status improved, and by week 4, the skin lesions had completely resolved. Although initially she did well on immunosuppressive therapy with resolution of all symptoms, the patient contracted Clostridium difficile–induced systemic inflammatory response syndrome after 5 weeks of therapy and died.
Hydralazine was first introduced in 1951 for adjunctive hypertension therapy due to its vasodilation effects.1-3 Since its introduction, it has been implicated in 2 important disease processes: HIAV and hydralazine-induced lupus.
Hydralazine-induced ANCA vasculitis was first documented in 1980; by 2011, multiple cases had been reported.1-7 Hydralazine-induced ANCA vasculitis has occurred in patients aged 11 to 79 years taking 50 to 300 mg daily. Symptom onset varies from 6 months to 14 years, with a mean exposure duration of 4.7 years and mean daily dose of 142 mg.1-7
Clinical manifestations range from less specific, such as fever, malaise, arthralgia, myalgia, and weight loss, to single tissue or organ involvement that may be fatal. The most frequent clinical features include kidney involvement (81%), cutaneous vasculitis (25%), arthralgia (24%), and pleuropulmonary involvement (19%). Cutaneous manifestations include but are not limited to palpable lower extremity purpura; morbilliform eruptions; and hemorrhagic blisters on the lower legs, arms, trunk, nasal septum, and uvula.1-4,8
The most commonly affected organ is the kidney, which commonly presents as hematuria, proteinuria, and elevated serum creatinine level. Histopathologically, patients most likely will have necrotizing and crescentic glomerulonephritis that is pauci-immune by immunofluorescence.7,9 The lungs are the next most commonly affected organ, with a classic presentation of cough, dyspnea, and hemoptysis in the setting of intra-alveolar hemorrhage.6,8 When both the kidneys and lungs are involved, the patient is said to have pulmonary-renal syndrome that is characterized by lung infiltrates or nodules with or without hemorrhage, hemoptysis, and pleuritis in the setting of glomerulonephritis.1,6
Clear data on incidence and prevalence of HIAV does not exist due to the rarity of the disease and the lack of prospective studies. To identify a clear incidence and prevalence, prospective longitudinal studies with larger cohorts along with better recognition and diagnosis are needed.2,8,10 A few predisposing risk factors have been identified, including older age, a cumulative dose of 100 g at the time of presentation, female sex, a history of thyroid disease, HLA-DR4 genotypes, slow hepatic acetylation, and the null gene for C4.1,3,5,9-11 Our patient was an older woman with a history of thyroid disease who had been taking oral hydralazine 75 mg 3 times daily for 13 months. During this 13-month duration, she had no dose adjustments.
Currently, the pathomechanism for HIAV is unclear and may be multifactorial. There are 4 main theories2,8-10,12,13:
1. Hydralazine and its metabolites accumulate inside neutrophils, then subsequently bind and alter the configuration of myeloperoxidase (MPO). This alteration leads to spreading of the autoimmune response to other autoantigens, making neutrophil proteins (eg, elastase, lactoferrin, nuclear antigens) immunogenic.
2. Hydralazine binds MPO in neutrophils, creating cytotoxic products that induce neutrophil apoptosis. Neutrophil apoptosis without priming then results in ANCA antigen presence on the neutrophil cell membrane and the formation of MPO-ANCA. Myeloperoxidase-ANCA then binds to these membrane-bound antigens that cause self-perpetuating, constitutive activation through cross-linking with proteinase 3 or MPO and Fcγ receptors.
3. Activated neutrophils in the presence of hydrogen peroxidase release MPO that converts hydralazine into a cytotoxic product that is immunogenic for T cells that activate ANCA-producing B cells.
4. Histone H3 trimethyl Lys27 (H3K27me3) levels are perturbed in HIAV, which leads to aberrant gene silencing of proteinase 3 and MPO.In contrast, the demethylase Jumonji domain-containing protein 3 for the H3K27me3 histone is increased in patients without HIAV. Based on this data and the data showing a role for hydralazine in reversing epigenetic silencing of tumor suppressor genes in cancer cells,13 it has been proposed that hydralazine may reverse epigenetic silencing of proteinase 3 and MPO.
Diagnosing HIAV is still difficult because physicians do not recognize the drug as the etiologic agent, there is extensive variability in duration between starting the drug and onset of symptoms, and there often is a failure to order the appropriate laboratory and invasive tests needed for evaluation and diagnosis.3,5,8,10,12 Despite these difficulties, a set of criteria and practices for diagnosis are delineated in Table 1, with the key diagnostic feature being resolution with hydralazine cessation.1,5,7,8,12
A comprehensive drug history from at least 6 months prior to presentation is essential. Biopsies also are strongly encouraged to confirm the presence of vasculitis and to determine its severity.8,12 If renal biopsies are performed, they typically show scant IgG, IgM, and C3 deposition that is characteristic of ANCA-positive pauci-immune glomerulonephritis. Compared to hydralazine-induced lupus, renal involvement in the setting of HIAV has a relative lack of immunoglobulin and complement deposition with histopathology and immunostaining.14
Laboratory test results including serum MPO-ANCA (perinuclear ANCA) with coexisting elastase and/or lactoferrin autoantibodies is characteristic of HIAV. Antinuclear antibody, antihistone, anti–double-stranded DNA, and antiphospholipid antibodies along with low complement levels also may be present.2,4,9,10,13,15 It is recommended that ANCA assays combine indirect immunofluorescence with antigen-specific enzyme-linked immunosorbent assay.8 With respect to its idiopathic counterpart, patients may only present with MPO-ANCA, while other aforementioned antibodies (eg, antihistone, anti–double-stranded DNA) are rarely found or are entirely absent.2,9 Patients with HIAV often have higher titers of MPO-ANCA.9,15 In hydralazine-induced lupus, patients rarely have MPO-ANCA.
When a diagnosis of HIAV is made, it cannot be confirmed until hydralazine is discontinued and the patient’s symptoms resolve. Therefore, it is both diagnostic and therapeutic to discontinue hydralazine when HIAV is suspected. If recognized when the patient is only presenting with nonspecific symptoms, simple hydralazine cessation may be all that is needed; however, because recognition and diagnosis of HIAV is difficult, most patients present when the disease is severe and has progressed to organ involvement.8-10
Treatment recommendations are highlighted in Table 2.8,9,12 Glucocorticoid therapy is believed to work by preventing T-cell and B-cell maturation needed to produce MPO-ANCA. Rituximab, on the other hand, is suspected to act by clearing the peripheral blood of MPO-ANCA B cells.12,16 Of note, patients with HIAV are different from their idiopathic counterparts because they usually need shorter courses of immunosuppressive therapy, long-term maintenance usually is unnecessary, and their prognosis generally is good if the offending agent is withdrawn.7-9,12 Once the appropriate therapy is instituted, vasculitic manifestations are expected to resolve 10 days to 8 months after hydralazine cessation; however, a response often is seen within 1 to 4 weeks after initiation of systemic treatment.4,8 Serum ANCA should be monitored, and there should be surveillance for the emergence of a chronic underlying vasculitis.8,12
Our patient highlights the importance of identifying individuals at risk for HIAV. We seek to increase recognition of this entity, as it is not commonly seen in a dermatologic setting and is associated with high morbidity and mortality, as seen in our patient.
- Yokogawa N, Vivino FB. Hydralazine-induced autoimmune disease: comparison to idiopathic lupus and ANCA-positive vasculitis. Mod Rheumatol. 2009;19:338-347.
- Agarwal G, Sultan G, Werner SL, et al. Hydralazine induces myeloperoxidase and proteinase 3 anti-neutrophil cytoplasmic antibody vasculitis and leads to pulmonary renal syndrome. Case Rep Nephrol. 2014;2014:868590.
- Keasberry J, Frazier J, Isbel NM, et al. Hydralazine-induced anti-neutrophilic cytoplasmic antibody-positive renal vasculitis presenting with a vasculitic syndrome, acute nephritis and a puzzling skin rash: a case report. J Med Case Rep. 2013;7:20.
- ten Holder SM, Joy MS, Falk RJ. Cutaneous and systemic manifestations of drug-induced vasculitis. Ann Pharmacother. 2002;36:130-147.
- Namas R, Rubin B, Adwar W, et al. A challenging twist in pulmonary renal syndrome. Case Rep Rheumatol. 2014;2014:516362.
- Dobre M, Wish J, Negrea L. Hydralazine-induced ANCA-positive pauci-immune glomerulonephritis. Ren Fail. 2009;31:745-748.
- Hogan JJ, Markowitz GS, Radhakrishnan J. Drug-induced glomerular disease: immune-mediated injury. Clin J Am Soc Nephrol. 2015;10:1300-1310.
- Radic M, Martinovic Kaliterna D, Radic J. Drug-induced vasculitis: a clinical and pathological review. Neth J Med. 2012;70:12-17.
- Babar F, Posner JN, Obah EA. Hydralazine-induced pauci-immune glomerulonephritis: intriguing case series misleading diagnoses. J Community Hosp Intern Med Perspect. 2016;6:30632.
- Marina VP, Malhotra D, Kaw D. Hydralazine-induced ANCA vasculitis with pulmonary renal syndrome: a rare clinical presentation. Int Urol Nephrol. 2012;44:1907-1909.
- Magro CM. Associated ANCA positive vasculitis. The Dermatologist. 2015;23(7). http://www.the-dermatologist.com/content/associated-anca-positive-vasculitis. Accessed January 30, 2020.
- Gao Y, Zhao MH. Review article: Drug-induced anti-neutrophil cytoplasmic antibody-associated vasculitis. Nephrology (Carlton). 2009;14:33-41.
- Grau RG. Drug-induced vasculitis: new insights and a changing lineup of suspects. Curr Rheumatol Rep. 2015;17:71.
- Sangala N, Lee RW, Horsfield C, et al. Combined ANCA-associated vasculitis and lupus syndrome following prolonged use of hydralazine: a timely reminder of an old foe. Int Urol Nephrol. 2010;42:503-506.
- Choi HK, Merkel PA, Walker AM, et al. Drug-associated antineutrophil cytoplasmic antibody-positive vasculitis: prevalence among patients with high titers of antimyeloperoxidase antibodies. Arthritis Rheum. 2000;43:405-413.
- Coutinho AE, Chapman KE. The anti-inflammatory and immunosuppressive effects of glucocorticoids, recent developments and mechanistic insights. Mol Cell Endocrinol. 2011;335:2-13.
To the Editor:
Hydralazine-induced antineutrophil cytoplasmic antibody vasculitis (HIAV) is a rare side effect that may develop in patients treated with hydralazine. Without early recognition and hydralazine cessation, patients often develop acute renal failure and pulmonary hemorrhage that may result in death. We present a case of HIAV.
A 67-year-old woman presented with progressive, tense, hemorrhagic, and necrotic bullae on both sides of the face and neck as well as the extremities of 2 weeks’ duration. She had a history of hypertension and a thyroid nodule after unilateral thyroid lobectomy. A review of symptoms was positive for worsening dyspnea and progressive generalized weakness. Noteworthy medications included amlodipine, metoprolol, levothyroxine, and oral hydralazine 75 mg 3 times daily for 13 months.
Bullae first appeared on the patient’s scalp and quickly progressed with a cephalocaudal pattern with a propensity for the eyes, nostrils, and labial mucosa (Figure 1). The tongue was covered by an eschar, and she had diffuse periorbital edema. Additionally, concentric purpuric patches were noted on the thighs and lower legs (Figure 2).
Pertinent laboratory findings included a positive antinuclear antibody titer of 1:320 and perinuclear antineutrophil cytoplasmic antibody (ANCA) titer of 1:160, along with an elevated serum creatinine level (2.31 mg/dL [reference range, 0.6–1.2 mg/dL]). Bilateral perihilar infiltrates with bilateral pleural effusions were noted on a chest radiograph.
While hospitalized, she developed pulmonary hemorrhages and a progressive decline in respiratory status. She subsequently was admitted to the medical intensive care unit. Aggressive support was administered, and several skin biopsy specimens were obtained along with an endobronchial biopsy of the right middle lobe.
Skin histopathology revealed a necrotic vasculitis (Figure 3). Direct immunofluorescence was not performed. Lung histopathology showed fragments of bronchial tissue with acute and chronic inflammation, focal necrosis, granulation tissue formation, edema, and squamous metaplasia. Together with the clinical history, these findings were consistent with HIAV.
Hydralazine was immediately discontinued, and the patient was started on 65 mg daily of intravenous methylprednisolone; methylprednisolone was later changed to oral prednisone 30 mg daily. Due to multiple organ involvement—lung and kidney—intravenous rituximab 375 mg/m2 every week for 4 weeks, per lymphoma protocol, was started. Within 2 weeks of beginning therapy, her renal function and respiratory status improved, and by week 4, the skin lesions had completely resolved. Although initially she did well on immunosuppressive therapy with resolution of all symptoms, the patient contracted Clostridium difficile–induced systemic inflammatory response syndrome after 5 weeks of therapy and died.
Hydralazine was first introduced in 1951 for adjunctive hypertension therapy due to its vasodilation effects.1-3 Since its introduction, it has been implicated in 2 important disease processes: HIAV and hydralazine-induced lupus.
Hydralazine-induced ANCA vasculitis was first documented in 1980; by 2011, multiple cases had been reported.1-7 Hydralazine-induced ANCA vasculitis has occurred in patients aged 11 to 79 years taking 50 to 300 mg daily. Symptom onset varies from 6 months to 14 years, with a mean exposure duration of 4.7 years and mean daily dose of 142 mg.1-7
Clinical manifestations range from less specific, such as fever, malaise, arthralgia, myalgia, and weight loss, to single tissue or organ involvement that may be fatal. The most frequent clinical features include kidney involvement (81%), cutaneous vasculitis (25%), arthralgia (24%), and pleuropulmonary involvement (19%). Cutaneous manifestations include but are not limited to palpable lower extremity purpura; morbilliform eruptions; and hemorrhagic blisters on the lower legs, arms, trunk, nasal septum, and uvula.1-4,8
The most commonly affected organ is the kidney, which commonly presents as hematuria, proteinuria, and elevated serum creatinine level. Histopathologically, patients most likely will have necrotizing and crescentic glomerulonephritis that is pauci-immune by immunofluorescence.7,9 The lungs are the next most commonly affected organ, with a classic presentation of cough, dyspnea, and hemoptysis in the setting of intra-alveolar hemorrhage.6,8 When both the kidneys and lungs are involved, the patient is said to have pulmonary-renal syndrome that is characterized by lung infiltrates or nodules with or without hemorrhage, hemoptysis, and pleuritis in the setting of glomerulonephritis.1,6
Clear data on incidence and prevalence of HIAV does not exist due to the rarity of the disease and the lack of prospective studies. To identify a clear incidence and prevalence, prospective longitudinal studies with larger cohorts along with better recognition and diagnosis are needed.2,8,10 A few predisposing risk factors have been identified, including older age, a cumulative dose of 100 g at the time of presentation, female sex, a history of thyroid disease, HLA-DR4 genotypes, slow hepatic acetylation, and the null gene for C4.1,3,5,9-11 Our patient was an older woman with a history of thyroid disease who had been taking oral hydralazine 75 mg 3 times daily for 13 months. During this 13-month duration, she had no dose adjustments.
Currently, the pathomechanism for HIAV is unclear and may be multifactorial. There are 4 main theories2,8-10,12,13:
1. Hydralazine and its metabolites accumulate inside neutrophils, then subsequently bind and alter the configuration of myeloperoxidase (MPO). This alteration leads to spreading of the autoimmune response to other autoantigens, making neutrophil proteins (eg, elastase, lactoferrin, nuclear antigens) immunogenic.
2. Hydralazine binds MPO in neutrophils, creating cytotoxic products that induce neutrophil apoptosis. Neutrophil apoptosis without priming then results in ANCA antigen presence on the neutrophil cell membrane and the formation of MPO-ANCA. Myeloperoxidase-ANCA then binds to these membrane-bound antigens that cause self-perpetuating, constitutive activation through cross-linking with proteinase 3 or MPO and Fcγ receptors.
3. Activated neutrophils in the presence of hydrogen peroxidase release MPO that converts hydralazine into a cytotoxic product that is immunogenic for T cells that activate ANCA-producing B cells.
4. Histone H3 trimethyl Lys27 (H3K27me3) levels are perturbed in HIAV, which leads to aberrant gene silencing of proteinase 3 and MPO.In contrast, the demethylase Jumonji domain-containing protein 3 for the H3K27me3 histone is increased in patients without HIAV. Based on this data and the data showing a role for hydralazine in reversing epigenetic silencing of tumor suppressor genes in cancer cells,13 it has been proposed that hydralazine may reverse epigenetic silencing of proteinase 3 and MPO.
Diagnosing HIAV is still difficult because physicians do not recognize the drug as the etiologic agent, there is extensive variability in duration between starting the drug and onset of symptoms, and there often is a failure to order the appropriate laboratory and invasive tests needed for evaluation and diagnosis.3,5,8,10,12 Despite these difficulties, a set of criteria and practices for diagnosis are delineated in Table 1, with the key diagnostic feature being resolution with hydralazine cessation.1,5,7,8,12
A comprehensive drug history from at least 6 months prior to presentation is essential. Biopsies also are strongly encouraged to confirm the presence of vasculitis and to determine its severity.8,12 If renal biopsies are performed, they typically show scant IgG, IgM, and C3 deposition that is characteristic of ANCA-positive pauci-immune glomerulonephritis. Compared to hydralazine-induced lupus, renal involvement in the setting of HIAV has a relative lack of immunoglobulin and complement deposition with histopathology and immunostaining.14
Laboratory test results including serum MPO-ANCA (perinuclear ANCA) with coexisting elastase and/or lactoferrin autoantibodies is characteristic of HIAV. Antinuclear antibody, antihistone, anti–double-stranded DNA, and antiphospholipid antibodies along with low complement levels also may be present.2,4,9,10,13,15 It is recommended that ANCA assays combine indirect immunofluorescence with antigen-specific enzyme-linked immunosorbent assay.8 With respect to its idiopathic counterpart, patients may only present with MPO-ANCA, while other aforementioned antibodies (eg, antihistone, anti–double-stranded DNA) are rarely found or are entirely absent.2,9 Patients with HIAV often have higher titers of MPO-ANCA.9,15 In hydralazine-induced lupus, patients rarely have MPO-ANCA.
When a diagnosis of HIAV is made, it cannot be confirmed until hydralazine is discontinued and the patient’s symptoms resolve. Therefore, it is both diagnostic and therapeutic to discontinue hydralazine when HIAV is suspected. If recognized when the patient is only presenting with nonspecific symptoms, simple hydralazine cessation may be all that is needed; however, because recognition and diagnosis of HIAV is difficult, most patients present when the disease is severe and has progressed to organ involvement.8-10
Treatment recommendations are highlighted in Table 2.8,9,12 Glucocorticoid therapy is believed to work by preventing T-cell and B-cell maturation needed to produce MPO-ANCA. Rituximab, on the other hand, is suspected to act by clearing the peripheral blood of MPO-ANCA B cells.12,16 Of note, patients with HIAV are different from their idiopathic counterparts because they usually need shorter courses of immunosuppressive therapy, long-term maintenance usually is unnecessary, and their prognosis generally is good if the offending agent is withdrawn.7-9,12 Once the appropriate therapy is instituted, vasculitic manifestations are expected to resolve 10 days to 8 months after hydralazine cessation; however, a response often is seen within 1 to 4 weeks after initiation of systemic treatment.4,8 Serum ANCA should be monitored, and there should be surveillance for the emergence of a chronic underlying vasculitis.8,12
Our patient highlights the importance of identifying individuals at risk for HIAV. We seek to increase recognition of this entity, as it is not commonly seen in a dermatologic setting and is associated with high morbidity and mortality, as seen in our patient.
To the Editor:
Hydralazine-induced antineutrophil cytoplasmic antibody vasculitis (HIAV) is a rare side effect that may develop in patients treated with hydralazine. Without early recognition and hydralazine cessation, patients often develop acute renal failure and pulmonary hemorrhage that may result in death. We present a case of HIAV.
A 67-year-old woman presented with progressive, tense, hemorrhagic, and necrotic bullae on both sides of the face and neck as well as the extremities of 2 weeks’ duration. She had a history of hypertension and a thyroid nodule after unilateral thyroid lobectomy. A review of symptoms was positive for worsening dyspnea and progressive generalized weakness. Noteworthy medications included amlodipine, metoprolol, levothyroxine, and oral hydralazine 75 mg 3 times daily for 13 months.
Bullae first appeared on the patient’s scalp and quickly progressed with a cephalocaudal pattern with a propensity for the eyes, nostrils, and labial mucosa (Figure 1). The tongue was covered by an eschar, and she had diffuse periorbital edema. Additionally, concentric purpuric patches were noted on the thighs and lower legs (Figure 2).
Pertinent laboratory findings included a positive antinuclear antibody titer of 1:320 and perinuclear antineutrophil cytoplasmic antibody (ANCA) titer of 1:160, along with an elevated serum creatinine level (2.31 mg/dL [reference range, 0.6–1.2 mg/dL]). Bilateral perihilar infiltrates with bilateral pleural effusions were noted on a chest radiograph.
While hospitalized, she developed pulmonary hemorrhages and a progressive decline in respiratory status. She subsequently was admitted to the medical intensive care unit. Aggressive support was administered, and several skin biopsy specimens were obtained along with an endobronchial biopsy of the right middle lobe.
Skin histopathology revealed a necrotic vasculitis (Figure 3). Direct immunofluorescence was not performed. Lung histopathology showed fragments of bronchial tissue with acute and chronic inflammation, focal necrosis, granulation tissue formation, edema, and squamous metaplasia. Together with the clinical history, these findings were consistent with HIAV.
Hydralazine was immediately discontinued, and the patient was started on 65 mg daily of intravenous methylprednisolone; methylprednisolone was later changed to oral prednisone 30 mg daily. Due to multiple organ involvement—lung and kidney—intravenous rituximab 375 mg/m2 every week for 4 weeks, per lymphoma protocol, was started. Within 2 weeks of beginning therapy, her renal function and respiratory status improved, and by week 4, the skin lesions had completely resolved. Although initially she did well on immunosuppressive therapy with resolution of all symptoms, the patient contracted Clostridium difficile–induced systemic inflammatory response syndrome after 5 weeks of therapy and died.
Hydralazine was first introduced in 1951 for adjunctive hypertension therapy due to its vasodilation effects.1-3 Since its introduction, it has been implicated in 2 important disease processes: HIAV and hydralazine-induced lupus.
Hydralazine-induced ANCA vasculitis was first documented in 1980; by 2011, multiple cases had been reported.1-7 Hydralazine-induced ANCA vasculitis has occurred in patients aged 11 to 79 years taking 50 to 300 mg daily. Symptom onset varies from 6 months to 14 years, with a mean exposure duration of 4.7 years and mean daily dose of 142 mg.1-7
Clinical manifestations range from less specific, such as fever, malaise, arthralgia, myalgia, and weight loss, to single tissue or organ involvement that may be fatal. The most frequent clinical features include kidney involvement (81%), cutaneous vasculitis (25%), arthralgia (24%), and pleuropulmonary involvement (19%). Cutaneous manifestations include but are not limited to palpable lower extremity purpura; morbilliform eruptions; and hemorrhagic blisters on the lower legs, arms, trunk, nasal septum, and uvula.1-4,8
The most commonly affected organ is the kidney, which commonly presents as hematuria, proteinuria, and elevated serum creatinine level. Histopathologically, patients most likely will have necrotizing and crescentic glomerulonephritis that is pauci-immune by immunofluorescence.7,9 The lungs are the next most commonly affected organ, with a classic presentation of cough, dyspnea, and hemoptysis in the setting of intra-alveolar hemorrhage.6,8 When both the kidneys and lungs are involved, the patient is said to have pulmonary-renal syndrome that is characterized by lung infiltrates or nodules with or without hemorrhage, hemoptysis, and pleuritis in the setting of glomerulonephritis.1,6
Clear data on incidence and prevalence of HIAV does not exist due to the rarity of the disease and the lack of prospective studies. To identify a clear incidence and prevalence, prospective longitudinal studies with larger cohorts along with better recognition and diagnosis are needed.2,8,10 A few predisposing risk factors have been identified, including older age, a cumulative dose of 100 g at the time of presentation, female sex, a history of thyroid disease, HLA-DR4 genotypes, slow hepatic acetylation, and the null gene for C4.1,3,5,9-11 Our patient was an older woman with a history of thyroid disease who had been taking oral hydralazine 75 mg 3 times daily for 13 months. During this 13-month duration, she had no dose adjustments.
Currently, the pathomechanism for HIAV is unclear and may be multifactorial. There are 4 main theories2,8-10,12,13:
1. Hydralazine and its metabolites accumulate inside neutrophils, then subsequently bind and alter the configuration of myeloperoxidase (MPO). This alteration leads to spreading of the autoimmune response to other autoantigens, making neutrophil proteins (eg, elastase, lactoferrin, nuclear antigens) immunogenic.
2. Hydralazine binds MPO in neutrophils, creating cytotoxic products that induce neutrophil apoptosis. Neutrophil apoptosis without priming then results in ANCA antigen presence on the neutrophil cell membrane and the formation of MPO-ANCA. Myeloperoxidase-ANCA then binds to these membrane-bound antigens that cause self-perpetuating, constitutive activation through cross-linking with proteinase 3 or MPO and Fcγ receptors.
3. Activated neutrophils in the presence of hydrogen peroxidase release MPO that converts hydralazine into a cytotoxic product that is immunogenic for T cells that activate ANCA-producing B cells.
4. Histone H3 trimethyl Lys27 (H3K27me3) levels are perturbed in HIAV, which leads to aberrant gene silencing of proteinase 3 and MPO.In contrast, the demethylase Jumonji domain-containing protein 3 for the H3K27me3 histone is increased in patients without HIAV. Based on this data and the data showing a role for hydralazine in reversing epigenetic silencing of tumor suppressor genes in cancer cells,13 it has been proposed that hydralazine may reverse epigenetic silencing of proteinase 3 and MPO.
Diagnosing HIAV is still difficult because physicians do not recognize the drug as the etiologic agent, there is extensive variability in duration between starting the drug and onset of symptoms, and there often is a failure to order the appropriate laboratory and invasive tests needed for evaluation and diagnosis.3,5,8,10,12 Despite these difficulties, a set of criteria and practices for diagnosis are delineated in Table 1, with the key diagnostic feature being resolution with hydralazine cessation.1,5,7,8,12
A comprehensive drug history from at least 6 months prior to presentation is essential. Biopsies also are strongly encouraged to confirm the presence of vasculitis and to determine its severity.8,12 If renal biopsies are performed, they typically show scant IgG, IgM, and C3 deposition that is characteristic of ANCA-positive pauci-immune glomerulonephritis. Compared to hydralazine-induced lupus, renal involvement in the setting of HIAV has a relative lack of immunoglobulin and complement deposition with histopathology and immunostaining.14
Laboratory test results including serum MPO-ANCA (perinuclear ANCA) with coexisting elastase and/or lactoferrin autoantibodies is characteristic of HIAV. Antinuclear antibody, antihistone, anti–double-stranded DNA, and antiphospholipid antibodies along with low complement levels also may be present.2,4,9,10,13,15 It is recommended that ANCA assays combine indirect immunofluorescence with antigen-specific enzyme-linked immunosorbent assay.8 With respect to its idiopathic counterpart, patients may only present with MPO-ANCA, while other aforementioned antibodies (eg, antihistone, anti–double-stranded DNA) are rarely found or are entirely absent.2,9 Patients with HIAV often have higher titers of MPO-ANCA.9,15 In hydralazine-induced lupus, patients rarely have MPO-ANCA.
When a diagnosis of HIAV is made, it cannot be confirmed until hydralazine is discontinued and the patient’s symptoms resolve. Therefore, it is both diagnostic and therapeutic to discontinue hydralazine when HIAV is suspected. If recognized when the patient is only presenting with nonspecific symptoms, simple hydralazine cessation may be all that is needed; however, because recognition and diagnosis of HIAV is difficult, most patients present when the disease is severe and has progressed to organ involvement.8-10
Treatment recommendations are highlighted in Table 2.8,9,12 Glucocorticoid therapy is believed to work by preventing T-cell and B-cell maturation needed to produce MPO-ANCA. Rituximab, on the other hand, is suspected to act by clearing the peripheral blood of MPO-ANCA B cells.12,16 Of note, patients with HIAV are different from their idiopathic counterparts because they usually need shorter courses of immunosuppressive therapy, long-term maintenance usually is unnecessary, and their prognosis generally is good if the offending agent is withdrawn.7-9,12 Once the appropriate therapy is instituted, vasculitic manifestations are expected to resolve 10 days to 8 months after hydralazine cessation; however, a response often is seen within 1 to 4 weeks after initiation of systemic treatment.4,8 Serum ANCA should be monitored, and there should be surveillance for the emergence of a chronic underlying vasculitis.8,12
Our patient highlights the importance of identifying individuals at risk for HIAV. We seek to increase recognition of this entity, as it is not commonly seen in a dermatologic setting and is associated with high morbidity and mortality, as seen in our patient.
- Yokogawa N, Vivino FB. Hydralazine-induced autoimmune disease: comparison to idiopathic lupus and ANCA-positive vasculitis. Mod Rheumatol. 2009;19:338-347.
- Agarwal G, Sultan G, Werner SL, et al. Hydralazine induces myeloperoxidase and proteinase 3 anti-neutrophil cytoplasmic antibody vasculitis and leads to pulmonary renal syndrome. Case Rep Nephrol. 2014;2014:868590.
- Keasberry J, Frazier J, Isbel NM, et al. Hydralazine-induced anti-neutrophilic cytoplasmic antibody-positive renal vasculitis presenting with a vasculitic syndrome, acute nephritis and a puzzling skin rash: a case report. J Med Case Rep. 2013;7:20.
- ten Holder SM, Joy MS, Falk RJ. Cutaneous and systemic manifestations of drug-induced vasculitis. Ann Pharmacother. 2002;36:130-147.
- Namas R, Rubin B, Adwar W, et al. A challenging twist in pulmonary renal syndrome. Case Rep Rheumatol. 2014;2014:516362.
- Dobre M, Wish J, Negrea L. Hydralazine-induced ANCA-positive pauci-immune glomerulonephritis. Ren Fail. 2009;31:745-748.
- Hogan JJ, Markowitz GS, Radhakrishnan J. Drug-induced glomerular disease: immune-mediated injury. Clin J Am Soc Nephrol. 2015;10:1300-1310.
- Radic M, Martinovic Kaliterna D, Radic J. Drug-induced vasculitis: a clinical and pathological review. Neth J Med. 2012;70:12-17.
- Babar F, Posner JN, Obah EA. Hydralazine-induced pauci-immune glomerulonephritis: intriguing case series misleading diagnoses. J Community Hosp Intern Med Perspect. 2016;6:30632.
- Marina VP, Malhotra D, Kaw D. Hydralazine-induced ANCA vasculitis with pulmonary renal syndrome: a rare clinical presentation. Int Urol Nephrol. 2012;44:1907-1909.
- Magro CM. Associated ANCA positive vasculitis. The Dermatologist. 2015;23(7). http://www.the-dermatologist.com/content/associated-anca-positive-vasculitis. Accessed January 30, 2020.
- Gao Y, Zhao MH. Review article: Drug-induced anti-neutrophil cytoplasmic antibody-associated vasculitis. Nephrology (Carlton). 2009;14:33-41.
- Grau RG. Drug-induced vasculitis: new insights and a changing lineup of suspects. Curr Rheumatol Rep. 2015;17:71.
- Sangala N, Lee RW, Horsfield C, et al. Combined ANCA-associated vasculitis and lupus syndrome following prolonged use of hydralazine: a timely reminder of an old foe. Int Urol Nephrol. 2010;42:503-506.
- Choi HK, Merkel PA, Walker AM, et al. Drug-associated antineutrophil cytoplasmic antibody-positive vasculitis: prevalence among patients with high titers of antimyeloperoxidase antibodies. Arthritis Rheum. 2000;43:405-413.
- Coutinho AE, Chapman KE. The anti-inflammatory and immunosuppressive effects of glucocorticoids, recent developments and mechanistic insights. Mol Cell Endocrinol. 2011;335:2-13.
- Yokogawa N, Vivino FB. Hydralazine-induced autoimmune disease: comparison to idiopathic lupus and ANCA-positive vasculitis. Mod Rheumatol. 2009;19:338-347.
- Agarwal G, Sultan G, Werner SL, et al. Hydralazine induces myeloperoxidase and proteinase 3 anti-neutrophil cytoplasmic antibody vasculitis and leads to pulmonary renal syndrome. Case Rep Nephrol. 2014;2014:868590.
- Keasberry J, Frazier J, Isbel NM, et al. Hydralazine-induced anti-neutrophilic cytoplasmic antibody-positive renal vasculitis presenting with a vasculitic syndrome, acute nephritis and a puzzling skin rash: a case report. J Med Case Rep. 2013;7:20.
- ten Holder SM, Joy MS, Falk RJ. Cutaneous and systemic manifestations of drug-induced vasculitis. Ann Pharmacother. 2002;36:130-147.
- Namas R, Rubin B, Adwar W, et al. A challenging twist in pulmonary renal syndrome. Case Rep Rheumatol. 2014;2014:516362.
- Dobre M, Wish J, Negrea L. Hydralazine-induced ANCA-positive pauci-immune glomerulonephritis. Ren Fail. 2009;31:745-748.
- Hogan JJ, Markowitz GS, Radhakrishnan J. Drug-induced glomerular disease: immune-mediated injury. Clin J Am Soc Nephrol. 2015;10:1300-1310.
- Radic M, Martinovic Kaliterna D, Radic J. Drug-induced vasculitis: a clinical and pathological review. Neth J Med. 2012;70:12-17.
- Babar F, Posner JN, Obah EA. Hydralazine-induced pauci-immune glomerulonephritis: intriguing case series misleading diagnoses. J Community Hosp Intern Med Perspect. 2016;6:30632.
- Marina VP, Malhotra D, Kaw D. Hydralazine-induced ANCA vasculitis with pulmonary renal syndrome: a rare clinical presentation. Int Urol Nephrol. 2012;44:1907-1909.
- Magro CM. Associated ANCA positive vasculitis. The Dermatologist. 2015;23(7). http://www.the-dermatologist.com/content/associated-anca-positive-vasculitis. Accessed January 30, 2020.
- Gao Y, Zhao MH. Review article: Drug-induced anti-neutrophil cytoplasmic antibody-associated vasculitis. Nephrology (Carlton). 2009;14:33-41.
- Grau RG. Drug-induced vasculitis: new insights and a changing lineup of suspects. Curr Rheumatol Rep. 2015;17:71.
- Sangala N, Lee RW, Horsfield C, et al. Combined ANCA-associated vasculitis and lupus syndrome following prolonged use of hydralazine: a timely reminder of an old foe. Int Urol Nephrol. 2010;42:503-506.
- Choi HK, Merkel PA, Walker AM, et al. Drug-associated antineutrophil cytoplasmic antibody-positive vasculitis: prevalence among patients with high titers of antimyeloperoxidase antibodies. Arthritis Rheum. 2000;43:405-413.
- Coutinho AE, Chapman KE. The anti-inflammatory and immunosuppressive effects of glucocorticoids, recent developments and mechanistic insights. Mol Cell Endocrinol. 2011;335:2-13.
Practice Points
- Hydralazine-induced antineutrophil cytoplasmic antibody vasculitis (HIAV) is a rare side effect of hydralazine treatment and can have notable morbidity and mortality.
- Incidence and prevalence of HIAV is unclear due to its rarity, but risk factors that have been identified are older age, a cumulative dose of 100 g of hydralazine at the time of presentation, female sex, thyroid disease, HLA-DR4 genotypes, slow hepatic acetylation, and the null gene for C4.
- Symptoms of HIAV can include fever, malaise, arthralgia, weight loss, or even involvement of organs such as the kidneys and lungs.
- If recognized early, cessation of hydralazine and supportive therapy generally are sufficient; however, severe cases may need management with high-dose corticosteroids, rituximab, and even plasmapheresis.
Consider PET/CT when infectious source is a puzzler
CHICAGO – Dual positron emission tomography-computed tomography (PET/CT) scans changed the treatment course of nearly half of patients whose scans were positive for infection. In a single-center systematic review of 18fluorodeoxyglucose (FDG)–PET/CT scans, 55 of the 138 scans (40%) changed clinical management.
Presenting the findings at the annual meeting of the Radiological Society of North America, Benjamin Viglianti, MD, PhD, said that PET/CT had particular utility in cases of bacteremia and endocarditis, in which the scans changed treatment in 46% of those cases.
Dr. Viglianti, a radiologist at the University of Michigan, Ann Arbor, explained that medical student and first author Anitha Menon, himself, and their collaborators deliberately used a broad definition of clinical management change. The management course was considered to change not only if an unknown infection site was discovered or if a new intervention was initiated after the scan, but also if antibiotic choice or duration was changed or an additional specialty was consulted.
Scans were included in the study if an infectious etiology was found in the scan and if the patient received an infectious disease consult. Bacteremia and endocarditis were the most frequent indications for scans and also the indications for which management was most frequently changed. When a vascular cause was the indication for the scan, management changed 41% of the time. For fevers of unknown origin, the scan changed management in 30% of the cases, while for osteomyelitis, management was changed for 28% of patients.
The investigators identified several broad themes from their review that pointed toward when clinicians might consider FDG-PET/CT imaging in infectious disease management.
The first, said Dr. Viglianti, was that “for patients with suspected vascular graft infection, PET/CT using FDG may be a good first-choice imaging modality.” He pointed to an illustrative case of a patient who was 1 month out from open repair of a thoracoabdominal aortic aneurysm. The patient had abdominal pain, epigastric tenderness and nausea, as well as an erythematous incision site. A CT scan just revealed an abdominal fluid collection, but the PET/CT scan showed radiotracer uptake at the prior repair site, indicating infection.
For patients with bacteremia, the investigators judged that FDG-PET/CT might be particularly useful in patients who have a graft, prosthetic valve, or cardiac device. Here, Dr. Viglianti and his collaborators highlighted the scan of a woman with DiGeorge syndrome who had received aortic root replacement for truncus arteriosis. She had been found to have persistent enterococcal bacteremia at high levels, but had been symptom free. To take a close look at the suspected infectious nidus, a transesophageal echocardiogram had been obtained, but this study didn’t turn up any clear masses or vegetations. The PET/CT scan, though, revealed avid FDG uptake in the area of the prosthesis.
Management course was not likely to be changed for patients with fever of unknown origin, but the investigators did note that whole-body PET/CT was useful to distinguish infectious etiologies from hematologic and oncologic processes. Their review included a patient who had Crohn’s disease and fever, myalgias, and upper abdominal pain, as well as liver enzyme elevation. The PET/CT showed radiotracer uptake within the spleen, which was enlarged. The scan also showed bone marrow uptake; these findings pointed toward hemophagocytic lymphohistiocytosis rather than an infectious etiology.
For osteomyelitis, said Dr. Viglianti, FDG-PET may have limited utility; it might be most useful when MRI is contraindicated. Within the study population, the investigators identified a patient who had chills and fever along with focal tenderness over the lumbar spine in the context of recent pyelonephritis of a graft kidney. Here, MRI findings were suspicious for osteomyelitis and diskitis, and the FDG uptake at the L4-L5 vertebral levels confirmed the MRI results.
When a patient with a prosthetic valve is suspected of having endocarditis, “cardiac PET/CT may be of high diagnostic value,” said Dr. Viglianti. For patients with endocarditis of native valves, though, a full-body FDG-PET/CT scan may spot septic emboli. A patient identified in the investigators’ review had been admitted for methicillin-resistant Staphylococcus aureus endocarditis. The patient, who had a history of intravenous drug use, received a transesophageal echocardiogram that found severe tricuspid valve regurgitation and vegetations. The whole-body PET/CT scan, though, revealed avid uptake in both buttocks, as well as thigh, ankle and calf muscles – a pattern “suspicious for infectious myositis,” said the researchers.
In discussion during the poster session, Dr. Viglianti said that, although reimbursement for PET/CT scans for infectious etiologies might not be feasible, it can still be a reasonable and even cost-effective choice. At his institution, he said, the requisite radioisotope is made in-house, twice daily, so it’s relatively easy to arrange scans. Since PET/CT scans can be acquired relatively quickly and there’s no delay while waiting for radiotracer uptake, clinical decisions can be made more quickly than when waiting for bone uptake for a technetium-99 scan, he said. This can have the effect of saving a night of hospitalization in many cases.
Dr. Viglianti and Ms. Menon reported that they had no relevant conflicts of interest. No outside sources of funding were reported.
SOURCE: Menon A et al. RSNA 2019, Abstract NM203-SDSUB1.
CHICAGO – Dual positron emission tomography-computed tomography (PET/CT) scans changed the treatment course of nearly half of patients whose scans were positive for infection. In a single-center systematic review of 18fluorodeoxyglucose (FDG)–PET/CT scans, 55 of the 138 scans (40%) changed clinical management.
Presenting the findings at the annual meeting of the Radiological Society of North America, Benjamin Viglianti, MD, PhD, said that PET/CT had particular utility in cases of bacteremia and endocarditis, in which the scans changed treatment in 46% of those cases.
Dr. Viglianti, a radiologist at the University of Michigan, Ann Arbor, explained that medical student and first author Anitha Menon, himself, and their collaborators deliberately used a broad definition of clinical management change. The management course was considered to change not only if an unknown infection site was discovered or if a new intervention was initiated after the scan, but also if antibiotic choice or duration was changed or an additional specialty was consulted.
Scans were included in the study if an infectious etiology was found in the scan and if the patient received an infectious disease consult. Bacteremia and endocarditis were the most frequent indications for scans and also the indications for which management was most frequently changed. When a vascular cause was the indication for the scan, management changed 41% of the time. For fevers of unknown origin, the scan changed management in 30% of the cases, while for osteomyelitis, management was changed for 28% of patients.
The investigators identified several broad themes from their review that pointed toward when clinicians might consider FDG-PET/CT imaging in infectious disease management.
The first, said Dr. Viglianti, was that “for patients with suspected vascular graft infection, PET/CT using FDG may be a good first-choice imaging modality.” He pointed to an illustrative case of a patient who was 1 month out from open repair of a thoracoabdominal aortic aneurysm. The patient had abdominal pain, epigastric tenderness and nausea, as well as an erythematous incision site. A CT scan just revealed an abdominal fluid collection, but the PET/CT scan showed radiotracer uptake at the prior repair site, indicating infection.
For patients with bacteremia, the investigators judged that FDG-PET/CT might be particularly useful in patients who have a graft, prosthetic valve, or cardiac device. Here, Dr. Viglianti and his collaborators highlighted the scan of a woman with DiGeorge syndrome who had received aortic root replacement for truncus arteriosis. She had been found to have persistent enterococcal bacteremia at high levels, but had been symptom free. To take a close look at the suspected infectious nidus, a transesophageal echocardiogram had been obtained, but this study didn’t turn up any clear masses or vegetations. The PET/CT scan, though, revealed avid FDG uptake in the area of the prosthesis.
Management course was not likely to be changed for patients with fever of unknown origin, but the investigators did note that whole-body PET/CT was useful to distinguish infectious etiologies from hematologic and oncologic processes. Their review included a patient who had Crohn’s disease and fever, myalgias, and upper abdominal pain, as well as liver enzyme elevation. The PET/CT showed radiotracer uptake within the spleen, which was enlarged. The scan also showed bone marrow uptake; these findings pointed toward hemophagocytic lymphohistiocytosis rather than an infectious etiology.
For osteomyelitis, said Dr. Viglianti, FDG-PET may have limited utility; it might be most useful when MRI is contraindicated. Within the study population, the investigators identified a patient who had chills and fever along with focal tenderness over the lumbar spine in the context of recent pyelonephritis of a graft kidney. Here, MRI findings were suspicious for osteomyelitis and diskitis, and the FDG uptake at the L4-L5 vertebral levels confirmed the MRI results.
When a patient with a prosthetic valve is suspected of having endocarditis, “cardiac PET/CT may be of high diagnostic value,” said Dr. Viglianti. For patients with endocarditis of native valves, though, a full-body FDG-PET/CT scan may spot septic emboli. A patient identified in the investigators’ review had been admitted for methicillin-resistant Staphylococcus aureus endocarditis. The patient, who had a history of intravenous drug use, received a transesophageal echocardiogram that found severe tricuspid valve regurgitation and vegetations. The whole-body PET/CT scan, though, revealed avid uptake in both buttocks, as well as thigh, ankle and calf muscles – a pattern “suspicious for infectious myositis,” said the researchers.
In discussion during the poster session, Dr. Viglianti said that, although reimbursement for PET/CT scans for infectious etiologies might not be feasible, it can still be a reasonable and even cost-effective choice. At his institution, he said, the requisite radioisotope is made in-house, twice daily, so it’s relatively easy to arrange scans. Since PET/CT scans can be acquired relatively quickly and there’s no delay while waiting for radiotracer uptake, clinical decisions can be made more quickly than when waiting for bone uptake for a technetium-99 scan, he said. This can have the effect of saving a night of hospitalization in many cases.
Dr. Viglianti and Ms. Menon reported that they had no relevant conflicts of interest. No outside sources of funding were reported.
SOURCE: Menon A et al. RSNA 2019, Abstract NM203-SDSUB1.
CHICAGO – Dual positron emission tomography-computed tomography (PET/CT) scans changed the treatment course of nearly half of patients whose scans were positive for infection. In a single-center systematic review of 18fluorodeoxyglucose (FDG)–PET/CT scans, 55 of the 138 scans (40%) changed clinical management.
Presenting the findings at the annual meeting of the Radiological Society of North America, Benjamin Viglianti, MD, PhD, said that PET/CT had particular utility in cases of bacteremia and endocarditis, in which the scans changed treatment in 46% of those cases.
Dr. Viglianti, a radiologist at the University of Michigan, Ann Arbor, explained that medical student and first author Anitha Menon, himself, and their collaborators deliberately used a broad definition of clinical management change. The management course was considered to change not only if an unknown infection site was discovered or if a new intervention was initiated after the scan, but also if antibiotic choice or duration was changed or an additional specialty was consulted.
Scans were included in the study if an infectious etiology was found in the scan and if the patient received an infectious disease consult. Bacteremia and endocarditis were the most frequent indications for scans and also the indications for which management was most frequently changed. When a vascular cause was the indication for the scan, management changed 41% of the time. For fevers of unknown origin, the scan changed management in 30% of the cases, while for osteomyelitis, management was changed for 28% of patients.
The investigators identified several broad themes from their review that pointed toward when clinicians might consider FDG-PET/CT imaging in infectious disease management.
The first, said Dr. Viglianti, was that “for patients with suspected vascular graft infection, PET/CT using FDG may be a good first-choice imaging modality.” He pointed to an illustrative case of a patient who was 1 month out from open repair of a thoracoabdominal aortic aneurysm. The patient had abdominal pain, epigastric tenderness and nausea, as well as an erythematous incision site. A CT scan just revealed an abdominal fluid collection, but the PET/CT scan showed radiotracer uptake at the prior repair site, indicating infection.
For patients with bacteremia, the investigators judged that FDG-PET/CT might be particularly useful in patients who have a graft, prosthetic valve, or cardiac device. Here, Dr. Viglianti and his collaborators highlighted the scan of a woman with DiGeorge syndrome who had received aortic root replacement for truncus arteriosis. She had been found to have persistent enterococcal bacteremia at high levels, but had been symptom free. To take a close look at the suspected infectious nidus, a transesophageal echocardiogram had been obtained, but this study didn’t turn up any clear masses or vegetations. The PET/CT scan, though, revealed avid FDG uptake in the area of the prosthesis.
Management course was not likely to be changed for patients with fever of unknown origin, but the investigators did note that whole-body PET/CT was useful to distinguish infectious etiologies from hematologic and oncologic processes. Their review included a patient who had Crohn’s disease and fever, myalgias, and upper abdominal pain, as well as liver enzyme elevation. The PET/CT showed radiotracer uptake within the spleen, which was enlarged. The scan also showed bone marrow uptake; these findings pointed toward hemophagocytic lymphohistiocytosis rather than an infectious etiology.
For osteomyelitis, said Dr. Viglianti, FDG-PET may have limited utility; it might be most useful when MRI is contraindicated. Within the study population, the investigators identified a patient who had chills and fever along with focal tenderness over the lumbar spine in the context of recent pyelonephritis of a graft kidney. Here, MRI findings were suspicious for osteomyelitis and diskitis, and the FDG uptake at the L4-L5 vertebral levels confirmed the MRI results.
When a patient with a prosthetic valve is suspected of having endocarditis, “cardiac PET/CT may be of high diagnostic value,” said Dr. Viglianti. For patients with endocarditis of native valves, though, a full-body FDG-PET/CT scan may spot septic emboli. A patient identified in the investigators’ review had been admitted for methicillin-resistant Staphylococcus aureus endocarditis. The patient, who had a history of intravenous drug use, received a transesophageal echocardiogram that found severe tricuspid valve regurgitation and vegetations. The whole-body PET/CT scan, though, revealed avid uptake in both buttocks, as well as thigh, ankle and calf muscles – a pattern “suspicious for infectious myositis,” said the researchers.
In discussion during the poster session, Dr. Viglianti said that, although reimbursement for PET/CT scans for infectious etiologies might not be feasible, it can still be a reasonable and even cost-effective choice. At his institution, he said, the requisite radioisotope is made in-house, twice daily, so it’s relatively easy to arrange scans. Since PET/CT scans can be acquired relatively quickly and there’s no delay while waiting for radiotracer uptake, clinical decisions can be made more quickly than when waiting for bone uptake for a technetium-99 scan, he said. This can have the effect of saving a night of hospitalization in many cases.
Dr. Viglianti and Ms. Menon reported that they had no relevant conflicts of interest. No outside sources of funding were reported.
SOURCE: Menon A et al. RSNA 2019, Abstract NM203-SDSUB1.
REPORTING FROM RSNA 2019
Older NHL survivors show worse cognitive decline
Older long-term survivors of non-Hodgkin lymphoma (NHL) may have worse cognitive outcomes compared with the noncancer aging population, according to a cross-sectional study.
The findings suggest additional research is needed to better understand cognitive decline in older survivors of NHL.
“The aim of the present study was to examine the difference in cognitive status between a group of long-term older survivors of NHL compared with a group of noncancer controls of the same age,” wrote Domenico La Carpia, MD, of Fondazione ANT Italia Onlus, Florence, Italy, and colleagues.
The researchers conducted a multicenter cross-sectional cohort study involving 63 long-term survivors of NHL and 61 age-matched controls. Their report was published in the Journal of Geriatric Oncology.
Eligible survivors and controls were aged 65 years and older. Among both groups, the mean age of study participants was 74 years, and most survivors were women (58.7%).
While cognitive decline was assessed via standardized neuropsychological testing, the team also evaluated polypharmacy, functional status, and level of multimorbidity in the cohort.
Other clinical data, including the time from complete remission, type of treatment received, and histopathological type of tumor, were collected from patient charts and included in the analysis.
After analysis, the researchers found that NHL survivors had a higher mean number of chronic conditions (3.4 vs. 2.3; P = .003), were receiving more medications (3.4 vs. 2.3; P = .03), and had worse functional status compared with controls.
In addition, survivors had impaired executive functioning compared with control subjects (Trail Making Test B-A, 47.9 vs. 32.1; P = .04), but scores on the Mini Mental State Examination (MMSE) did not differ between the groups.
“A small, statistically significant difference was also observed in verbal memory scores between the two groups,” they reported.
The researchers acknowledged that a key limitation was the cross-sectional nature of the study; hence, causality cannot be inferred from the data.
“Comprehensive geriatric assessment for older cancer survivors is advisable to identify those individuals who are at highest risk of developing disability and to implement tailored early interventions,” they concluded.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: La Carpia D et al. J Geriatr Oncol. 2020 Jan 31. doi: 10.1016/j.jgo.2020.01.007.
Older long-term survivors of non-Hodgkin lymphoma (NHL) may have worse cognitive outcomes compared with the noncancer aging population, according to a cross-sectional study.
The findings suggest additional research is needed to better understand cognitive decline in older survivors of NHL.
“The aim of the present study was to examine the difference in cognitive status between a group of long-term older survivors of NHL compared with a group of noncancer controls of the same age,” wrote Domenico La Carpia, MD, of Fondazione ANT Italia Onlus, Florence, Italy, and colleagues.
The researchers conducted a multicenter cross-sectional cohort study involving 63 long-term survivors of NHL and 61 age-matched controls. Their report was published in the Journal of Geriatric Oncology.
Eligible survivors and controls were aged 65 years and older. Among both groups, the mean age of study participants was 74 years, and most survivors were women (58.7%).
While cognitive decline was assessed via standardized neuropsychological testing, the team also evaluated polypharmacy, functional status, and level of multimorbidity in the cohort.
Other clinical data, including the time from complete remission, type of treatment received, and histopathological type of tumor, were collected from patient charts and included in the analysis.
After analysis, the researchers found that NHL survivors had a higher mean number of chronic conditions (3.4 vs. 2.3; P = .003), were receiving more medications (3.4 vs. 2.3; P = .03), and had worse functional status compared with controls.
In addition, survivors had impaired executive functioning compared with control subjects (Trail Making Test B-A, 47.9 vs. 32.1; P = .04), but scores on the Mini Mental State Examination (MMSE) did not differ between the groups.
“A small, statistically significant difference was also observed in verbal memory scores between the two groups,” they reported.
The researchers acknowledged that a key limitation was the cross-sectional nature of the study; hence, causality cannot be inferred from the data.
“Comprehensive geriatric assessment for older cancer survivors is advisable to identify those individuals who are at highest risk of developing disability and to implement tailored early interventions,” they concluded.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: La Carpia D et al. J Geriatr Oncol. 2020 Jan 31. doi: 10.1016/j.jgo.2020.01.007.
Older long-term survivors of non-Hodgkin lymphoma (NHL) may have worse cognitive outcomes compared with the noncancer aging population, according to a cross-sectional study.
The findings suggest additional research is needed to better understand cognitive decline in older survivors of NHL.
“The aim of the present study was to examine the difference in cognitive status between a group of long-term older survivors of NHL compared with a group of noncancer controls of the same age,” wrote Domenico La Carpia, MD, of Fondazione ANT Italia Onlus, Florence, Italy, and colleagues.
The researchers conducted a multicenter cross-sectional cohort study involving 63 long-term survivors of NHL and 61 age-matched controls. Their report was published in the Journal of Geriatric Oncology.
Eligible survivors and controls were aged 65 years and older. Among both groups, the mean age of study participants was 74 years, and most survivors were women (58.7%).
While cognitive decline was assessed via standardized neuropsychological testing, the team also evaluated polypharmacy, functional status, and level of multimorbidity in the cohort.
Other clinical data, including the time from complete remission, type of treatment received, and histopathological type of tumor, were collected from patient charts and included in the analysis.
After analysis, the researchers found that NHL survivors had a higher mean number of chronic conditions (3.4 vs. 2.3; P = .003), were receiving more medications (3.4 vs. 2.3; P = .03), and had worse functional status compared with controls.
In addition, survivors had impaired executive functioning compared with control subjects (Trail Making Test B-A, 47.9 vs. 32.1; P = .04), but scores on the Mini Mental State Examination (MMSE) did not differ between the groups.
“A small, statistically significant difference was also observed in verbal memory scores between the two groups,” they reported.
The researchers acknowledged that a key limitation was the cross-sectional nature of the study; hence, causality cannot be inferred from the data.
“Comprehensive geriatric assessment for older cancer survivors is advisable to identify those individuals who are at highest risk of developing disability and to implement tailored early interventions,” they concluded.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: La Carpia D et al. J Geriatr Oncol. 2020 Jan 31. doi: 10.1016/j.jgo.2020.01.007.
FROM THE JOURNAL OF GERIATRIC ONCOLOGY
Fear drives activity changes in hemophilia patients
Fear of negative events can drive changes in activity levels among patients with hemophilia A, results of the HemACTIVE study suggest.
Patients were more likely to adjust their level of physical activity due to fear of bleeding and joint damage rather than previously experienced bleeding or joint damage.
However, past experience was more likely than fear to make patients stop physical activities altogether.
Mark Skinner, of the Institute for Policy Advancement in Washington, D.C., and colleagues presented these findings in a poster from the annual congress of the European Association for Haemophilia and Allied Disorders.
Mr. Skinner, who is a hemophilia patient himself, said the goal of the HemACTIVE study is to better understand how hemophilia affects patients’ lives.
“We wanted to understand the limitations, challenges, and compromises of individuals living with hemophilia,” Mr. Skinner said. “What has motivated them or prevented them from living more full, active lives doing the kind of work, leisure, and social activities that those without hemophilia do? Is it treatment choice, is it satisfaction with treatment, is it fear?
“We wanted to do a comprehensive study that really looked at the intersection of treatment adherence and satisfaction, the emotional components that relate to those decisions, and the challenges and compromises so that we could better identify what we need to consider as patients think about either changing their therapy or changing their treatment regimen on existing therapy.”
Previous results from the HemACTIVE study showed that, although activity levels differed among hemophilia patients, all patients surveyed wanted greater activity levels, better protection from bleeding, better pain relief, and less-frequent infusions (EAHAD 2019, Abstract P084). In addition, patients who used factor VIII products with an extended half-life were more active and more likely to adhere to their prescribed treatment (ISTH 2019, Abstract PB0210).
The results reported at EAHAD 2020 focus on patients’ reasons for modifying physical activity. Patients and caregivers completed a screening phone interview, followed by a 25-minute, web-based questionnaire on patient activity.
There were 275 respondents – 194 patients with hemophilia A and 81 caregivers – from Canada, France, Germany, Italy, and the United States. Patients had severe (61%) or moderate (39%) hemophilia A, and most (67%) were receiving prophylaxis.
Most patients (70%) were “active” or “extremely/very active,” 77% of patients adjusted their activities because of their hemophilia, and nearly half of patients stopped activities because of their disease.
Fear drives adjustments in activity
Patients were sometimes more likely to adjust their activities based on fear of experiencing an event, as opposed to previously experiencing that event.
Specifically, 44% of patients adjusted their activities due to fear of joint damage, compared with 36% of patients who made adjustments because of past significant joint damage.
Similarly, 41% of patients adjusted activities due to fear of breakthrough bleeds, compared with 36% of patients who made adjustments because of past experience with bleeds and 25% who made adjustments because of significant past bleeds.
On the other hand, a similar percentage of patients adjusted activities because of past experience with pain (43%) and fear of pain (41%). And a similar percentage of patients adjusted activities because of existing joint damage restrictions (35%) and fear of joint deterioration (32%).
Past experience prompts discontinuation of activity
Overall, 47% of patients said anxiety was the most common emotional reason for stopping physical activities. However, patients were consistently more likely to stop activities because of past experience rather than fear or anxiety.
Specifically, 50% of patients stopped activities because of significant past joint damage, 46% stopped because of developing joint problems, and 38% stopped due to fear of joint damage.
More patients stopped activities because of significant past bleeds (41%) rather than fear of breakthrough bleeds (26%). More patients stopped activities because they developed chronic pain (38%) rather than fear of pain (less than 15%). And more patients stopped activities because of existing joint damage restrictions (62%) rather than fear of joint damage (34%).
Applying results to practice: Changing the conversation
Ideally, these findings would be used to promote individualized treatment of hemophilia driven by patients’ goals, Mr. Skinner said. By better understanding patients’ feelings and motivations, clinicians may devise more personalized treatment regimens that align with patients’ goals and improve their quality of life.
Rather than adjusting treatment based only on “hard metrics” such as bleeding events, “we need to take a more holistic approach to looking at outcomes that are more important to patients,” Mr. Skinner said. This type of approach is particularly important to Mr. Skinner as someone who has severe hemophilia A.
“Because hemophilia is a life-long disease, and you’re born with it, you make conscious or unconscious adaptations throughout your life,” he explained. “Your expectations or aspirations adjust to what you’ve been told you can or cannot do because of your hemophilia. The choices I made for my career, where I live, the type of vacations I go on, the type of sports I participate in have all been limited over the course of time, which has meant that I’ve made compromises. There are a lot of individuals with hemophilia who are making decisions that are not what their life goals are.
“What this research helps me understand is that we can change the conversation and build it around an individual patient and understand what their aspirations are. If a clinician understands what I’m wanting to achieve in life … we can build a treatment regime around helping me achieve those goals. That is known to improve adherence.
“The goal, really, is to have hemophilia as a secondary consideration. Instead of saying: ‘You have hemophilia, so these are the options available to you,’ you can say, ‘what is it that you would like to achieve, and then we’ll figure out how your treatment for hemophilia can be adjusted to help you achieve those goals.’ It may sound like a nuance, but it really is reversing the conversation. The goal setting first versus your disease comes first.”
The HemACTIVE study was supported by Bayer. Mr. Skinner disclosed relationships with Bayer and other pharmaceutical companies.
SOURCE: Skinner M et al. EAHAD 2020, Abstract P304.
Fear of negative events can drive changes in activity levels among patients with hemophilia A, results of the HemACTIVE study suggest.
Patients were more likely to adjust their level of physical activity due to fear of bleeding and joint damage rather than previously experienced bleeding or joint damage.
However, past experience was more likely than fear to make patients stop physical activities altogether.
Mark Skinner, of the Institute for Policy Advancement in Washington, D.C., and colleagues presented these findings in a poster from the annual congress of the European Association for Haemophilia and Allied Disorders.
Mr. Skinner, who is a hemophilia patient himself, said the goal of the HemACTIVE study is to better understand how hemophilia affects patients’ lives.
“We wanted to understand the limitations, challenges, and compromises of individuals living with hemophilia,” Mr. Skinner said. “What has motivated them or prevented them from living more full, active lives doing the kind of work, leisure, and social activities that those without hemophilia do? Is it treatment choice, is it satisfaction with treatment, is it fear?
“We wanted to do a comprehensive study that really looked at the intersection of treatment adherence and satisfaction, the emotional components that relate to those decisions, and the challenges and compromises so that we could better identify what we need to consider as patients think about either changing their therapy or changing their treatment regimen on existing therapy.”
Previous results from the HemACTIVE study showed that, although activity levels differed among hemophilia patients, all patients surveyed wanted greater activity levels, better protection from bleeding, better pain relief, and less-frequent infusions (EAHAD 2019, Abstract P084). In addition, patients who used factor VIII products with an extended half-life were more active and more likely to adhere to their prescribed treatment (ISTH 2019, Abstract PB0210).
The results reported at EAHAD 2020 focus on patients’ reasons for modifying physical activity. Patients and caregivers completed a screening phone interview, followed by a 25-minute, web-based questionnaire on patient activity.
There were 275 respondents – 194 patients with hemophilia A and 81 caregivers – from Canada, France, Germany, Italy, and the United States. Patients had severe (61%) or moderate (39%) hemophilia A, and most (67%) were receiving prophylaxis.
Most patients (70%) were “active” or “extremely/very active,” 77% of patients adjusted their activities because of their hemophilia, and nearly half of patients stopped activities because of their disease.
Fear drives adjustments in activity
Patients were sometimes more likely to adjust their activities based on fear of experiencing an event, as opposed to previously experiencing that event.
Specifically, 44% of patients adjusted their activities due to fear of joint damage, compared with 36% of patients who made adjustments because of past significant joint damage.
Similarly, 41% of patients adjusted activities due to fear of breakthrough bleeds, compared with 36% of patients who made adjustments because of past experience with bleeds and 25% who made adjustments because of significant past bleeds.
On the other hand, a similar percentage of patients adjusted activities because of past experience with pain (43%) and fear of pain (41%). And a similar percentage of patients adjusted activities because of existing joint damage restrictions (35%) and fear of joint deterioration (32%).
Past experience prompts discontinuation of activity
Overall, 47% of patients said anxiety was the most common emotional reason for stopping physical activities. However, patients were consistently more likely to stop activities because of past experience rather than fear or anxiety.
Specifically, 50% of patients stopped activities because of significant past joint damage, 46% stopped because of developing joint problems, and 38% stopped due to fear of joint damage.
More patients stopped activities because of significant past bleeds (41%) rather than fear of breakthrough bleeds (26%). More patients stopped activities because they developed chronic pain (38%) rather than fear of pain (less than 15%). And more patients stopped activities because of existing joint damage restrictions (62%) rather than fear of joint damage (34%).
Applying results to practice: Changing the conversation
Ideally, these findings would be used to promote individualized treatment of hemophilia driven by patients’ goals, Mr. Skinner said. By better understanding patients’ feelings and motivations, clinicians may devise more personalized treatment regimens that align with patients’ goals and improve their quality of life.
Rather than adjusting treatment based only on “hard metrics” such as bleeding events, “we need to take a more holistic approach to looking at outcomes that are more important to patients,” Mr. Skinner said. This type of approach is particularly important to Mr. Skinner as someone who has severe hemophilia A.
“Because hemophilia is a life-long disease, and you’re born with it, you make conscious or unconscious adaptations throughout your life,” he explained. “Your expectations or aspirations adjust to what you’ve been told you can or cannot do because of your hemophilia. The choices I made for my career, where I live, the type of vacations I go on, the type of sports I participate in have all been limited over the course of time, which has meant that I’ve made compromises. There are a lot of individuals with hemophilia who are making decisions that are not what their life goals are.
“What this research helps me understand is that we can change the conversation and build it around an individual patient and understand what their aspirations are. If a clinician understands what I’m wanting to achieve in life … we can build a treatment regime around helping me achieve those goals. That is known to improve adherence.
“The goal, really, is to have hemophilia as a secondary consideration. Instead of saying: ‘You have hemophilia, so these are the options available to you,’ you can say, ‘what is it that you would like to achieve, and then we’ll figure out how your treatment for hemophilia can be adjusted to help you achieve those goals.’ It may sound like a nuance, but it really is reversing the conversation. The goal setting first versus your disease comes first.”
The HemACTIVE study was supported by Bayer. Mr. Skinner disclosed relationships with Bayer and other pharmaceutical companies.
SOURCE: Skinner M et al. EAHAD 2020, Abstract P304.
Fear of negative events can drive changes in activity levels among patients with hemophilia A, results of the HemACTIVE study suggest.
Patients were more likely to adjust their level of physical activity due to fear of bleeding and joint damage rather than previously experienced bleeding or joint damage.
However, past experience was more likely than fear to make patients stop physical activities altogether.
Mark Skinner, of the Institute for Policy Advancement in Washington, D.C., and colleagues presented these findings in a poster from the annual congress of the European Association for Haemophilia and Allied Disorders.
Mr. Skinner, who is a hemophilia patient himself, said the goal of the HemACTIVE study is to better understand how hemophilia affects patients’ lives.
“We wanted to understand the limitations, challenges, and compromises of individuals living with hemophilia,” Mr. Skinner said. “What has motivated them or prevented them from living more full, active lives doing the kind of work, leisure, and social activities that those without hemophilia do? Is it treatment choice, is it satisfaction with treatment, is it fear?
“We wanted to do a comprehensive study that really looked at the intersection of treatment adherence and satisfaction, the emotional components that relate to those decisions, and the challenges and compromises so that we could better identify what we need to consider as patients think about either changing their therapy or changing their treatment regimen on existing therapy.”
Previous results from the HemACTIVE study showed that, although activity levels differed among hemophilia patients, all patients surveyed wanted greater activity levels, better protection from bleeding, better pain relief, and less-frequent infusions (EAHAD 2019, Abstract P084). In addition, patients who used factor VIII products with an extended half-life were more active and more likely to adhere to their prescribed treatment (ISTH 2019, Abstract PB0210).
The results reported at EAHAD 2020 focus on patients’ reasons for modifying physical activity. Patients and caregivers completed a screening phone interview, followed by a 25-minute, web-based questionnaire on patient activity.
There were 275 respondents – 194 patients with hemophilia A and 81 caregivers – from Canada, France, Germany, Italy, and the United States. Patients had severe (61%) or moderate (39%) hemophilia A, and most (67%) were receiving prophylaxis.
Most patients (70%) were “active” or “extremely/very active,” 77% of patients adjusted their activities because of their hemophilia, and nearly half of patients stopped activities because of their disease.
Fear drives adjustments in activity
Patients were sometimes more likely to adjust their activities based on fear of experiencing an event, as opposed to previously experiencing that event.
Specifically, 44% of patients adjusted their activities due to fear of joint damage, compared with 36% of patients who made adjustments because of past significant joint damage.
Similarly, 41% of patients adjusted activities due to fear of breakthrough bleeds, compared with 36% of patients who made adjustments because of past experience with bleeds and 25% who made adjustments because of significant past bleeds.
On the other hand, a similar percentage of patients adjusted activities because of past experience with pain (43%) and fear of pain (41%). And a similar percentage of patients adjusted activities because of existing joint damage restrictions (35%) and fear of joint deterioration (32%).
Past experience prompts discontinuation of activity
Overall, 47% of patients said anxiety was the most common emotional reason for stopping physical activities. However, patients were consistently more likely to stop activities because of past experience rather than fear or anxiety.
Specifically, 50% of patients stopped activities because of significant past joint damage, 46% stopped because of developing joint problems, and 38% stopped due to fear of joint damage.
More patients stopped activities because of significant past bleeds (41%) rather than fear of breakthrough bleeds (26%). More patients stopped activities because they developed chronic pain (38%) rather than fear of pain (less than 15%). And more patients stopped activities because of existing joint damage restrictions (62%) rather than fear of joint damage (34%).
Applying results to practice: Changing the conversation
Ideally, these findings would be used to promote individualized treatment of hemophilia driven by patients’ goals, Mr. Skinner said. By better understanding patients’ feelings and motivations, clinicians may devise more personalized treatment regimens that align with patients’ goals and improve their quality of life.
Rather than adjusting treatment based only on “hard metrics” such as bleeding events, “we need to take a more holistic approach to looking at outcomes that are more important to patients,” Mr. Skinner said. This type of approach is particularly important to Mr. Skinner as someone who has severe hemophilia A.
“Because hemophilia is a life-long disease, and you’re born with it, you make conscious or unconscious adaptations throughout your life,” he explained. “Your expectations or aspirations adjust to what you’ve been told you can or cannot do because of your hemophilia. The choices I made for my career, where I live, the type of vacations I go on, the type of sports I participate in have all been limited over the course of time, which has meant that I’ve made compromises. There are a lot of individuals with hemophilia who are making decisions that are not what their life goals are.
“What this research helps me understand is that we can change the conversation and build it around an individual patient and understand what their aspirations are. If a clinician understands what I’m wanting to achieve in life … we can build a treatment regime around helping me achieve those goals. That is known to improve adherence.
“The goal, really, is to have hemophilia as a secondary consideration. Instead of saying: ‘You have hemophilia, so these are the options available to you,’ you can say, ‘what is it that you would like to achieve, and then we’ll figure out how your treatment for hemophilia can be adjusted to help you achieve those goals.’ It may sound like a nuance, but it really is reversing the conversation. The goal setting first versus your disease comes first.”
The HemACTIVE study was supported by Bayer. Mr. Skinner disclosed relationships with Bayer and other pharmaceutical companies.
SOURCE: Skinner M et al. EAHAD 2020, Abstract P304.
REPORTING FROM EAHAD 2020
Medicare study evaluates impact of U.S. Hospital Readmissions Reduction Program
Research offers evidence against calls to curtail the program
Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.
The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.
“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).
“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”
Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.
During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).
The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.
Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.
“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.
They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”
Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.
SOURCE: Khera et al. BMJ 2020;368:l6831.
Research offers evidence against calls to curtail the program
Research offers evidence against calls to curtail the program
Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.
The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.
“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).
“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”
Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.
During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).
The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.
Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.
“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.
They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”
Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.
SOURCE: Khera et al. BMJ 2020;368:l6831.
Among Medicare beneficiaries admitted to the hospital between 2008 and 2016, there was an increase in postdischarge 30-day mortality for patients with heart failure, but not for those with acute myocardial infarction or pneumonia.
The finding comes from an effort to evaluate the use of services soon after discharge for conditions targeted in the U.S. Hospital Readmissions Reduction Program (HRRP), and patients’ outcomes.
“The announcement and implementation of the HRRP were associated with a reduction in readmissions within 30 days of discharge for heart failure, acute myocardial infarction, and pneumonia, as shown by a decrease in the overall national rate of readmissions,” first author Rohan Khera, MD, and colleagues wrote in a study published online Jan. 15, 2020, in the British Medical Journal (doi:10.1136/bmj.l6831).
“Concerns existed that pressures to reduce readmissions had led to the evolution of care patterns that may have adverse consequences through reducing access to care in appropriate settings. Therefore, determining whether patients who are seen in acute care settings, but not admitted to hospital, experience an increased risk of mortality is essential.”
Dr. Khera, a cardiologist at the University of Texas Southwestern Medical Center, Dallas, and colleagues limited the analysis to Medicare claims data from patients who were admitted to the hospital with heart failure, acute myocardial infarction (MI), or pneumonia between 2008 and 2016. Key outcomes of interest were: (1) postdischarge 30-day mortality; and (2) acute care utilization in inpatient units, observation units, and the ED during the postdischarge period.
During the study period there were 3,772,924 hospital admissions for heart failure, 1,570,113 for acute MI, and 3,131,162 for pneumonia. The greatest number of readmissions within 30 days of discharge was for heart failure patients (22.5%), followed by acute MI (17.5%), and pneumonia (17.2%).
The overall rates of observation stays were 1.7% for heart failure, 2.6% for acute MI, and 1.4% for pneumonia, while the overall rates of emergency department visits were 6.4% for heart failure, 6.8% for acute MI, and 6.3% for pneumonia. Cumulatively, about one-third of all admissions – 30.7% for heart failure, 26.9% for acute MI, and 24.8% for pneumonia – received postdischarge care in any acute care setting.
Dr. Khera and colleagues found that overall postdischarge 30-day mortality was 8.7% for heart failure, 7.3% for acute MI, and 8.4% for pneumonia. At the same time, postdischarge 30-day mortality was higher in patients with readmissions (13.2% for heart failure, 12.7% for acute MI, and 15.3% for pneumonia), compared with those who had observation stays (4.5% for heart failure, 2.7% for acute MI, and 4.6% for pneumonia), emergency department visits (9.7% for heart failure, 8.8% for acute MI, and 7.8% for pneumonia), or no postdischarge acute care (7.2% for heart failure, 6.0% for acute MI, and 6.9% for pneumonia). Risk adjusted mortality increased annually by 0.05% only for heart failure, while it decreased by 0.06% for acute MI, and did not significantly change for pneumonia.
“The study strongly suggests that the HRRP did not lead to harm through inappropriate triage of patients at high risk to observation units and the emergency department, and therefore provides evidence against calls to curtail the program owing to this theoretical concern (see JAMA 2018;320:2539-41),” the researchers concluded.
They acknowledged certain limitations of the study, including the fact that they were “unable to identify patterns of acute care during the index hospital admission that would be associated with a higher rate of postdischarge acute care in observation units and emergency departments and whether these visits represented avenues for planned postdischarge follow-up care. Moreover, the proportion of these care encounters that were preventable remains poorly understood.”
Dr. Khera disclosed that he is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. His coauthors reported having numerous disclosures.
SOURCE: Khera et al. BMJ 2020;368:l6831.
FROM BMJ
Colorectal cancer risk elevated in anticoagulated AF patients with lower GI bleeding
A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.
“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.
To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.
Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.
All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).
The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”
Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.
SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.
A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.
“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.
To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.
Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.
All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).
The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”
Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.
SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.
A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.
“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.
To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.
Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.
All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).
The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”
Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.
SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.
FROM the European Heart Journal
Social determinants of health and the hospitalist
Are access to housing and food as important as therapeutics?
While physicians acknowledge that the social determinants of health can impact outcomes from medical care, some may feel that trying to address factors such as homelessness, food insecurity, or lack of ready access to transportation or pharmacy services is just not part of the doctor’s job. A majority of 621 physicians surveyed in the summer of 2017 by Salt Lake City–based health care intelligence firm Leavitt Partners say they are neither capable of nor responsible for addressing such issues.1
But that view may become unsustainable as the U.S. health care system continues to advance toward value- and population-based models of health care and as evidence mounts that social factors are important contributors to costly outcomes, such as avoidable hospital readmissions or emergency room visits. A recent report from the Robert Wood Johnson Foundation estimates that at least 40% of health outcomes are the result of social and economic factors, while only 20% can be attributed to medical care.2
“This is a hot topic – getting a lot of attention these days,” said hospitalist and care transitions expert Ramon Jacobs-Shaw, MD, MPA, regional medical officer for CareMore Health, a California-based physician-led health delivery organization and subsidiary of Anthem. “If you go around the country, some doctors still see social factors as the realm of the social worker. But large health care organizations are coming to recognize that social determinants are huge contributors to the health of their members and to the outcomes of their care.”
Hospitalists could be the natural providers to delve into the specific psychosocial aspects of their patients’ lives, or try to figure out how those factors contribute to health care needs, Dr. Jacobs-Shaw said. They typically confront such issues while the patient is in the hospital bed, but what are the steps that led to the hospitalization in the first place? What will happen after the patient is discharged?
“For example, if patients lack transportation, how can they get to their follow-up medical appointment in the primary care office in order to manage their diabetes? If you can’t follow up with them, their diabetes could get out of control, with complications as a result, such as an infected wound,” he said. Another big issue is access to affordable medications. “CareMore has pharmacists embedded on our care teams. They try to figure out the best medicine for the patient but at the lowest cost. They meet individually with patients and do medication counseling, particularly for those with polypharmacy issues.”
Making health care more equitable
Dr. Jacobs-Shaw has long held a personal interest in issues of inclusiveness, diversity, and how to make health care more equitable for historically underserved groups. Asking how to have a bigger impact on these issues is what brought him, after 13 years as a hospitalist on the East Coast, to CareMore, a company that has made addressing social needs central to its care model. “In California, where I am based, we are a wrap-around for patients who are covered by Medicare Advantage plans. We are whatever the patient needs us to be.”
He oversees a group of hospitalists, dubbed extensivists, who provide advanced patient care and chronic disease management. In the extensivist model, physicians and advanced practice nurses provide comprehensive and coordinated care to patients with complex medical issues, taking their scope of practice beyond the hospital into homes, post-acute care facilities, and other settings, with a focus on keeping patients healthier and reducing readmission.3
“Our patients get access to extra services and resources, some of which are available at our care centers – which are one-stop outpatient facilities. We also focus on a lot of things physicians didn’t historically think were within their wheelhouse. Hospitalists deal with these kinds of issues every day, but may not label them as social determinants of health,” Dr. Jacobs-Shaw said. He emphasized that hospitalists should realize that they are not powerless to address these issues, working in partnership with other groups in and out of the hospital. They should also know that health care payers increasingly are dedicating resources to these issues.
“We just started trying to address homelessness through a pilot in Orange County, working with nonprofit organizations and philanthropy to offer a transitional site of care for our patients who are being discharged from the hospital and have housing insecurity issues, to get them transitioned into more secure housing,” Dr. Jacobs-Shaw said. CareMore also has a transportation collaborative that offers no-cost, nonemergency transportation to medical appointments. “That’s meeting them where they are at, based on an assessment of their needs and resources.”
What are social determinants?
The social determinants of health – social, environmental, and other nonmedical factors that contribute to overall health status and medical need – have been defined by the World Health Organization as: “conditions in which people are born, grow, live, work, and age.” That is a broad complex of overlapping social and systems issues, but it provides a context for a broader understanding of the patient’s health and response to medical interventions.
Socioeconomic status is a huge determinant. Level of education may be more important than income if the person lacks the health literacy to navigate the system and access needed care. Housing instability may include poor sanitation, substandard dwellings, or unsafe neighborhoods – all of which can affect a person’s well-being. Environmental health may include compromised air quality – which can impact pulmonary health. Other issues include access to employment and child care, utility needs, and interpersonal violence.
A 2014 paper in Annals of Internal Medicine found that residence within a disadvantaged neighborhood was a factor in hospital readmission rates as often as was chronic pulmonary disease.4 A recent report on social determinants of health by the National Institute for Health Care Management notes that patients with food insecurity are 2.4 times more likely to go to the emergency room, while those with transportation needs are 2.6 times more likely.5
What can health care leaders do to better equip their clinicians and teams to help patients deal with this array of complex needs? Intermountain Healthcare, based in Salt Lake City, spearheaded in 2018 the development of the Alliance for the Determinants of Health, starting in the communities of Ogden and St. George, Utah. The Alliance seeks to promote health, improve access to care, and decrease health care costs through a charitable contribution of $12 million over 3 years to seed collaborative demonstration projects.
Lisa Nichols, assistant vice president for community health at Intermountain, said that, while hospitalists were not directly involved in planning the Alliance, hospitalists and ED physicians have become essential to the patient-screening process for health and social needs.
“We met with hospitalists, emergency departments, and hospital administrators, because we wanted their feedback on how to raise awareness of the social needs of patients,” she said. “They have good ideas. They see the patients who come in from the homeless shelters.”
Other hospitals are subsidizing apartments for homeless patients being discharged from the hospital. CommonSpirit Health, the new national Catholic health care organization formed by the 2019 merger of Dignity Health and Catholic Health Initiatives, has explored how to help create and sustain affordable housing in the communities it serves. Investments like this have inspired others, such as Kaiser Permanente, to get involved in supporting housing initiatives.6
Comprehensive community care
David Meltzer, MD, PhD, a hospitalist and professor of medicine at the University of Chicago, said most hospitalists these days believe social determinants of health are part of their job responsibilities.
“That’s not to say we all do it well. We may fail at addressing some of the barriers our patients face. But I don’t know anyone who still says it’s not their job,” he said.
Since 2012, Dr. Meltzer has led a pilot called Comprehensive Care Physicians (CCP), in which the same physician cares for patients with chronic health problems in the clinic and in the hospital, working with a team of nurse practitioners, social workers, care coordinators, and other specialists. A total of 2,000 patients with chronic health problems were enrolled in the study from 2012 to 2016, half assigned to standard care and half assigned to five CCP doctors. The result: The CCP model has shown large improvements in outcomes – particularly among the more vulnerable, less activated patients, is preferred by patients, and has significantly reduced health care utilization.
The next step for the research team is another randomized controlled trial called Comprehensive Care, Community, and Culture, designed to address unmet social needs. Study group patients will also be screened for unmet social needs and have access to a community health worker and to the initiative’s Artful Living Program, which includes community and cultural activities like yoga and dance classes, cooking classes, art classes, and music concerts. To address the complex dimensions and determinants of health, Dr. Meltzer explained, efforts to improve health must extend to sectors far beyond traditional health care.
“I think trying to understand your patients’ social and nonmedical needs starts with getting to know them, and asking about their needs,” he said. “The better you know them, the better you are able to make medical decisions that will promote positive outcomes.”
Sound Physicians, a national hospitalist company based in Tacoma, Wash., and working in 350 hospitals in 41 states, recently published a blog post on its website about the importance of social determinants of health.7 Sound Physicians participates in value-based care through bundled Medicare/Medicaid contracts based on episodes of care for hospitalized patients with certain diagnoses or DRGs, explained John Dickey, MD, the company’s chief medical officer for population health.
“We’ve been heavily involved in trying to improve cost and outcomes of care since 2015. Social determinants absolutely play into trying to lower costs of care and reduce rates of readmissions, which are often multifactorial in cause,” he said. Hospitalists are uniquely equipped to impact post-acute outcomes, Dr. Dickey said, working in partnership with a position Sound Physicians calls the clinical performance nurse.
“We can also partner with primary care providers, provide education for our hospitalist staff, and work with in-home care supports for patients such as these, who otherwise might end up in a skilled nursing facility – even though they’d rather be at home,” he said.
Innovations at Northwell Health
Northwell Health, a multihospital comprehensive health system serving the New York City metro area and Long Island, has shown innovative leadership in addressing social factors. The 23-hospital system initiated in early 2019 a 15-item Self-Reported Social Determinants Screening Tool, which is now used with hospitalized patients to connect them with the support they need to fully recover and avoid readmissions.
Northwell is also providing professional education on social determinants for different constituencies across its system, said Johanna Martinez, MD, MS, a hospitalist and GME Director of Diversity and Health Equity at the Zucker School of Medicine at Hofstra/Northwell. A day-long training retreat was offered to GME faculty, and learning platforms have been developed for physicians, social workers, nurses, and others.
“One of the questions that comes up is that if you find social needs, what do you do about them?” Dr. Martinez explained. That’s more a difficult challenge, she said, so at Northwell, orthopedic surgeons are now asking patients questions like: “What’s going to happen when you go home? What are your social supports? Can you get to the physical therapist’s office?”
Another example of Northwell’s innovations is its Food as Health Program, initially piloted at Long Island Jewish Hospital in Valley Stream, N.Y. Hospitalized patients are asked two questions using a validated screening tool called the Hunger Vital Sign to identify their food insecurities.8 Those who answer yes are referred to a dietitian, and if they have a nutrition-related diagnosis, they enter the multidisciplinary wraparound program.
A key element is the food and health center, located on the hospital campus, where they can get food to take home and referrals to other services, with culturally tailored, disease-specific food education incorporated into the discharge plan. One of the partnering organizations is Island Harvest Food Bank, which helps about 1 in every 10 residents of Long Island with their food insecurity issues.
“When I talk to clinicians, most of us went into medicine to save lives and cure people. Yet the research shows that no matter who we are, we can’t do the best work that our patients need unless we consider their social determinants,” Dr. Martinez said. Ultimately, she noted, there is a need to change the culture of health care. “We have to create system change, reimbursement change, policy change.”
Omolara Uwemedimo, MD, MPH, associate professor of pediatrics and occupational medicine at Northwell and a former nocturnist, said the treatment of illness and health improvement don’t begin in the hospital, they begin in the community. Identifying where people are struggling and what communities they come from requires a broader view of the provider’s role. “Are patients who are readmitted to the hospital generally coming from certain demographics or from certain zip codes?” she asked. “Start there. How can we better connect with those communities?”
Education is key
In 2020 and beyond, hospitalists will hear more about the social determinants of health, Dr. Jacobs-Shaw concluded. “Without addressing those social determinants, we aren’t going to be able to meaningfully impact outcomes or be effective stewards of health care costs – addressing the psychosocial factors and root causes of patients coming in and out of the hospital.”
He added that self-education is key for hospitalists and the teams they work with – to be more aware of the link between health outcomes and social determinants. Guidelines and other resources on social determinants of health are available from the American College of Physicians and the American Association of Family Physicians. ACP issued a position paper on addressing social determinants of health to improve patient care,while AAFP has a research page on its website dedicated to social determinants of health, highlighting a number of initiatives and resources for physicians and others.9
The American Hospital Association has produced fact sheets on ICD-10CM code categories for social determinants of health, including 11 ICD-10 “Z” codes, numbered Z55-Z65, which can be used for coding interventions to address social determinants of health. Other experts are looking at how to adapt the electronic health record to capture sociodemographic and behavioral factors, and then trigger referrals to resources in the hospital and the broader community, and how to mobilize artificial intelligence and machine learning to better identify social needs.
“Our doctors really want to be able to take care of the whole patient, while being stewards of health care resources. But sometimes we feel powerless and wonder how we can have a bigger impact on people, on populations” Dr. Jacobs-Shaw said. “Remember it only takes one voice within an organization to start to elevate this topic.”
References
1. Rappleye E. Physicians say social determinants of health are not their responsibility. Becker’s Hospital Review. 2018 May 15.
2. Robert Wood Johnson Foundation, University of Wisconsin Population Health Institute. County Health Rankings, 2014.
3. Freeman, GA. The extensivist model. Health Leaders Magazine, 2016 Sep 15.
4. Kind AJ et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: A retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74.
5. National Institute for Health Care Management. Addressing social determinants of health can improve community health & reduce costs.
6. Vial PB. Boundless collaboration: A philosophy for sustainable and stabilizing housing investment strategies. Health Progress: Journal of the Catholic Health Association of the United States. September-October 2019.
7. Social determinants of health: New solutions for growing complexities. Op-Med, a blog by Sound Physicians. 2019 Aug 1.
8. The hunger vital sign: A new standard of care for preventive health.
9. Daniel H et al. Addressing social determinants to improve patient care and promote health equity: An American College of Physicians position paper. Ann Intern Med. 2018;168:557-578.
Are access to housing and food as important as therapeutics?
Are access to housing and food as important as therapeutics?
While physicians acknowledge that the social determinants of health can impact outcomes from medical care, some may feel that trying to address factors such as homelessness, food insecurity, or lack of ready access to transportation or pharmacy services is just not part of the doctor’s job. A majority of 621 physicians surveyed in the summer of 2017 by Salt Lake City–based health care intelligence firm Leavitt Partners say they are neither capable of nor responsible for addressing such issues.1
But that view may become unsustainable as the U.S. health care system continues to advance toward value- and population-based models of health care and as evidence mounts that social factors are important contributors to costly outcomes, such as avoidable hospital readmissions or emergency room visits. A recent report from the Robert Wood Johnson Foundation estimates that at least 40% of health outcomes are the result of social and economic factors, while only 20% can be attributed to medical care.2
“This is a hot topic – getting a lot of attention these days,” said hospitalist and care transitions expert Ramon Jacobs-Shaw, MD, MPA, regional medical officer for CareMore Health, a California-based physician-led health delivery organization and subsidiary of Anthem. “If you go around the country, some doctors still see social factors as the realm of the social worker. But large health care organizations are coming to recognize that social determinants are huge contributors to the health of their members and to the outcomes of their care.”
Hospitalists could be the natural providers to delve into the specific psychosocial aspects of their patients’ lives, or try to figure out how those factors contribute to health care needs, Dr. Jacobs-Shaw said. They typically confront such issues while the patient is in the hospital bed, but what are the steps that led to the hospitalization in the first place? What will happen after the patient is discharged?
“For example, if patients lack transportation, how can they get to their follow-up medical appointment in the primary care office in order to manage their diabetes? If you can’t follow up with them, their diabetes could get out of control, with complications as a result, such as an infected wound,” he said. Another big issue is access to affordable medications. “CareMore has pharmacists embedded on our care teams. They try to figure out the best medicine for the patient but at the lowest cost. They meet individually with patients and do medication counseling, particularly for those with polypharmacy issues.”
Making health care more equitable
Dr. Jacobs-Shaw has long held a personal interest in issues of inclusiveness, diversity, and how to make health care more equitable for historically underserved groups. Asking how to have a bigger impact on these issues is what brought him, after 13 years as a hospitalist on the East Coast, to CareMore, a company that has made addressing social needs central to its care model. “In California, where I am based, we are a wrap-around for patients who are covered by Medicare Advantage plans. We are whatever the patient needs us to be.”
He oversees a group of hospitalists, dubbed extensivists, who provide advanced patient care and chronic disease management. In the extensivist model, physicians and advanced practice nurses provide comprehensive and coordinated care to patients with complex medical issues, taking their scope of practice beyond the hospital into homes, post-acute care facilities, and other settings, with a focus on keeping patients healthier and reducing readmission.3
“Our patients get access to extra services and resources, some of which are available at our care centers – which are one-stop outpatient facilities. We also focus on a lot of things physicians didn’t historically think were within their wheelhouse. Hospitalists deal with these kinds of issues every day, but may not label them as social determinants of health,” Dr. Jacobs-Shaw said. He emphasized that hospitalists should realize that they are not powerless to address these issues, working in partnership with other groups in and out of the hospital. They should also know that health care payers increasingly are dedicating resources to these issues.
“We just started trying to address homelessness through a pilot in Orange County, working with nonprofit organizations and philanthropy to offer a transitional site of care for our patients who are being discharged from the hospital and have housing insecurity issues, to get them transitioned into more secure housing,” Dr. Jacobs-Shaw said. CareMore also has a transportation collaborative that offers no-cost, nonemergency transportation to medical appointments. “That’s meeting them where they are at, based on an assessment of their needs and resources.”
What are social determinants?
The social determinants of health – social, environmental, and other nonmedical factors that contribute to overall health status and medical need – have been defined by the World Health Organization as: “conditions in which people are born, grow, live, work, and age.” That is a broad complex of overlapping social and systems issues, but it provides a context for a broader understanding of the patient’s health and response to medical interventions.
Socioeconomic status is a huge determinant. Level of education may be more important than income if the person lacks the health literacy to navigate the system and access needed care. Housing instability may include poor sanitation, substandard dwellings, or unsafe neighborhoods – all of which can affect a person’s well-being. Environmental health may include compromised air quality – which can impact pulmonary health. Other issues include access to employment and child care, utility needs, and interpersonal violence.
A 2014 paper in Annals of Internal Medicine found that residence within a disadvantaged neighborhood was a factor in hospital readmission rates as often as was chronic pulmonary disease.4 A recent report on social determinants of health by the National Institute for Health Care Management notes that patients with food insecurity are 2.4 times more likely to go to the emergency room, while those with transportation needs are 2.6 times more likely.5
What can health care leaders do to better equip their clinicians and teams to help patients deal with this array of complex needs? Intermountain Healthcare, based in Salt Lake City, spearheaded in 2018 the development of the Alliance for the Determinants of Health, starting in the communities of Ogden and St. George, Utah. The Alliance seeks to promote health, improve access to care, and decrease health care costs through a charitable contribution of $12 million over 3 years to seed collaborative demonstration projects.
Lisa Nichols, assistant vice president for community health at Intermountain, said that, while hospitalists were not directly involved in planning the Alliance, hospitalists and ED physicians have become essential to the patient-screening process for health and social needs.
“We met with hospitalists, emergency departments, and hospital administrators, because we wanted their feedback on how to raise awareness of the social needs of patients,” she said. “They have good ideas. They see the patients who come in from the homeless shelters.”
Other hospitals are subsidizing apartments for homeless patients being discharged from the hospital. CommonSpirit Health, the new national Catholic health care organization formed by the 2019 merger of Dignity Health and Catholic Health Initiatives, has explored how to help create and sustain affordable housing in the communities it serves. Investments like this have inspired others, such as Kaiser Permanente, to get involved in supporting housing initiatives.6
Comprehensive community care
David Meltzer, MD, PhD, a hospitalist and professor of medicine at the University of Chicago, said most hospitalists these days believe social determinants of health are part of their job responsibilities.
“That’s not to say we all do it well. We may fail at addressing some of the barriers our patients face. But I don’t know anyone who still says it’s not their job,” he said.
Since 2012, Dr. Meltzer has led a pilot called Comprehensive Care Physicians (CCP), in which the same physician cares for patients with chronic health problems in the clinic and in the hospital, working with a team of nurse practitioners, social workers, care coordinators, and other specialists. A total of 2,000 patients with chronic health problems were enrolled in the study from 2012 to 2016, half assigned to standard care and half assigned to five CCP doctors. The result: The CCP model has shown large improvements in outcomes – particularly among the more vulnerable, less activated patients, is preferred by patients, and has significantly reduced health care utilization.
The next step for the research team is another randomized controlled trial called Comprehensive Care, Community, and Culture, designed to address unmet social needs. Study group patients will also be screened for unmet social needs and have access to a community health worker and to the initiative’s Artful Living Program, which includes community and cultural activities like yoga and dance classes, cooking classes, art classes, and music concerts. To address the complex dimensions and determinants of health, Dr. Meltzer explained, efforts to improve health must extend to sectors far beyond traditional health care.
“I think trying to understand your patients’ social and nonmedical needs starts with getting to know them, and asking about their needs,” he said. “The better you know them, the better you are able to make medical decisions that will promote positive outcomes.”
Sound Physicians, a national hospitalist company based in Tacoma, Wash., and working in 350 hospitals in 41 states, recently published a blog post on its website about the importance of social determinants of health.7 Sound Physicians participates in value-based care through bundled Medicare/Medicaid contracts based on episodes of care for hospitalized patients with certain diagnoses or DRGs, explained John Dickey, MD, the company’s chief medical officer for population health.
“We’ve been heavily involved in trying to improve cost and outcomes of care since 2015. Social determinants absolutely play into trying to lower costs of care and reduce rates of readmissions, which are often multifactorial in cause,” he said. Hospitalists are uniquely equipped to impact post-acute outcomes, Dr. Dickey said, working in partnership with a position Sound Physicians calls the clinical performance nurse.
“We can also partner with primary care providers, provide education for our hospitalist staff, and work with in-home care supports for patients such as these, who otherwise might end up in a skilled nursing facility – even though they’d rather be at home,” he said.
Innovations at Northwell Health
Northwell Health, a multihospital comprehensive health system serving the New York City metro area and Long Island, has shown innovative leadership in addressing social factors. The 23-hospital system initiated in early 2019 a 15-item Self-Reported Social Determinants Screening Tool, which is now used with hospitalized patients to connect them with the support they need to fully recover and avoid readmissions.
Northwell is also providing professional education on social determinants for different constituencies across its system, said Johanna Martinez, MD, MS, a hospitalist and GME Director of Diversity and Health Equity at the Zucker School of Medicine at Hofstra/Northwell. A day-long training retreat was offered to GME faculty, and learning platforms have been developed for physicians, social workers, nurses, and others.
“One of the questions that comes up is that if you find social needs, what do you do about them?” Dr. Martinez explained. That’s more a difficult challenge, she said, so at Northwell, orthopedic surgeons are now asking patients questions like: “What’s going to happen when you go home? What are your social supports? Can you get to the physical therapist’s office?”
Another example of Northwell’s innovations is its Food as Health Program, initially piloted at Long Island Jewish Hospital in Valley Stream, N.Y. Hospitalized patients are asked two questions using a validated screening tool called the Hunger Vital Sign to identify their food insecurities.8 Those who answer yes are referred to a dietitian, and if they have a nutrition-related diagnosis, they enter the multidisciplinary wraparound program.
A key element is the food and health center, located on the hospital campus, where they can get food to take home and referrals to other services, with culturally tailored, disease-specific food education incorporated into the discharge plan. One of the partnering organizations is Island Harvest Food Bank, which helps about 1 in every 10 residents of Long Island with their food insecurity issues.
“When I talk to clinicians, most of us went into medicine to save lives and cure people. Yet the research shows that no matter who we are, we can’t do the best work that our patients need unless we consider their social determinants,” Dr. Martinez said. Ultimately, she noted, there is a need to change the culture of health care. “We have to create system change, reimbursement change, policy change.”
Omolara Uwemedimo, MD, MPH, associate professor of pediatrics and occupational medicine at Northwell and a former nocturnist, said the treatment of illness and health improvement don’t begin in the hospital, they begin in the community. Identifying where people are struggling and what communities they come from requires a broader view of the provider’s role. “Are patients who are readmitted to the hospital generally coming from certain demographics or from certain zip codes?” she asked. “Start there. How can we better connect with those communities?”
Education is key
In 2020 and beyond, hospitalists will hear more about the social determinants of health, Dr. Jacobs-Shaw concluded. “Without addressing those social determinants, we aren’t going to be able to meaningfully impact outcomes or be effective stewards of health care costs – addressing the psychosocial factors and root causes of patients coming in and out of the hospital.”
He added that self-education is key for hospitalists and the teams they work with – to be more aware of the link between health outcomes and social determinants. Guidelines and other resources on social determinants of health are available from the American College of Physicians and the American Association of Family Physicians. ACP issued a position paper on addressing social determinants of health to improve patient care,while AAFP has a research page on its website dedicated to social determinants of health, highlighting a number of initiatives and resources for physicians and others.9
The American Hospital Association has produced fact sheets on ICD-10CM code categories for social determinants of health, including 11 ICD-10 “Z” codes, numbered Z55-Z65, which can be used for coding interventions to address social determinants of health. Other experts are looking at how to adapt the electronic health record to capture sociodemographic and behavioral factors, and then trigger referrals to resources in the hospital and the broader community, and how to mobilize artificial intelligence and machine learning to better identify social needs.
“Our doctors really want to be able to take care of the whole patient, while being stewards of health care resources. But sometimes we feel powerless and wonder how we can have a bigger impact on people, on populations” Dr. Jacobs-Shaw said. “Remember it only takes one voice within an organization to start to elevate this topic.”
References
1. Rappleye E. Physicians say social determinants of health are not their responsibility. Becker’s Hospital Review. 2018 May 15.
2. Robert Wood Johnson Foundation, University of Wisconsin Population Health Institute. County Health Rankings, 2014.
3. Freeman, GA. The extensivist model. Health Leaders Magazine, 2016 Sep 15.
4. Kind AJ et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: A retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74.
5. National Institute for Health Care Management. Addressing social determinants of health can improve community health & reduce costs.
6. Vial PB. Boundless collaboration: A philosophy for sustainable and stabilizing housing investment strategies. Health Progress: Journal of the Catholic Health Association of the United States. September-October 2019.
7. Social determinants of health: New solutions for growing complexities. Op-Med, a blog by Sound Physicians. 2019 Aug 1.
8. The hunger vital sign: A new standard of care for preventive health.
9. Daniel H et al. Addressing social determinants to improve patient care and promote health equity: An American College of Physicians position paper. Ann Intern Med. 2018;168:557-578.
While physicians acknowledge that the social determinants of health can impact outcomes from medical care, some may feel that trying to address factors such as homelessness, food insecurity, or lack of ready access to transportation or pharmacy services is just not part of the doctor’s job. A majority of 621 physicians surveyed in the summer of 2017 by Salt Lake City–based health care intelligence firm Leavitt Partners say they are neither capable of nor responsible for addressing such issues.1
But that view may become unsustainable as the U.S. health care system continues to advance toward value- and population-based models of health care and as evidence mounts that social factors are important contributors to costly outcomes, such as avoidable hospital readmissions or emergency room visits. A recent report from the Robert Wood Johnson Foundation estimates that at least 40% of health outcomes are the result of social and economic factors, while only 20% can be attributed to medical care.2
“This is a hot topic – getting a lot of attention these days,” said hospitalist and care transitions expert Ramon Jacobs-Shaw, MD, MPA, regional medical officer for CareMore Health, a California-based physician-led health delivery organization and subsidiary of Anthem. “If you go around the country, some doctors still see social factors as the realm of the social worker. But large health care organizations are coming to recognize that social determinants are huge contributors to the health of their members and to the outcomes of their care.”
Hospitalists could be the natural providers to delve into the specific psychosocial aspects of their patients’ lives, or try to figure out how those factors contribute to health care needs, Dr. Jacobs-Shaw said. They typically confront such issues while the patient is in the hospital bed, but what are the steps that led to the hospitalization in the first place? What will happen after the patient is discharged?
“For example, if patients lack transportation, how can they get to their follow-up medical appointment in the primary care office in order to manage their diabetes? If you can’t follow up with them, their diabetes could get out of control, with complications as a result, such as an infected wound,” he said. Another big issue is access to affordable medications. “CareMore has pharmacists embedded on our care teams. They try to figure out the best medicine for the patient but at the lowest cost. They meet individually with patients and do medication counseling, particularly for those with polypharmacy issues.”
Making health care more equitable
Dr. Jacobs-Shaw has long held a personal interest in issues of inclusiveness, diversity, and how to make health care more equitable for historically underserved groups. Asking how to have a bigger impact on these issues is what brought him, after 13 years as a hospitalist on the East Coast, to CareMore, a company that has made addressing social needs central to its care model. “In California, where I am based, we are a wrap-around for patients who are covered by Medicare Advantage plans. We are whatever the patient needs us to be.”
He oversees a group of hospitalists, dubbed extensivists, who provide advanced patient care and chronic disease management. In the extensivist model, physicians and advanced practice nurses provide comprehensive and coordinated care to patients with complex medical issues, taking their scope of practice beyond the hospital into homes, post-acute care facilities, and other settings, with a focus on keeping patients healthier and reducing readmission.3
“Our patients get access to extra services and resources, some of which are available at our care centers – which are one-stop outpatient facilities. We also focus on a lot of things physicians didn’t historically think were within their wheelhouse. Hospitalists deal with these kinds of issues every day, but may not label them as social determinants of health,” Dr. Jacobs-Shaw said. He emphasized that hospitalists should realize that they are not powerless to address these issues, working in partnership with other groups in and out of the hospital. They should also know that health care payers increasingly are dedicating resources to these issues.
“We just started trying to address homelessness through a pilot in Orange County, working with nonprofit organizations and philanthropy to offer a transitional site of care for our patients who are being discharged from the hospital and have housing insecurity issues, to get them transitioned into more secure housing,” Dr. Jacobs-Shaw said. CareMore also has a transportation collaborative that offers no-cost, nonemergency transportation to medical appointments. “That’s meeting them where they are at, based on an assessment of their needs and resources.”
What are social determinants?
The social determinants of health – social, environmental, and other nonmedical factors that contribute to overall health status and medical need – have been defined by the World Health Organization as: “conditions in which people are born, grow, live, work, and age.” That is a broad complex of overlapping social and systems issues, but it provides a context for a broader understanding of the patient’s health and response to medical interventions.
Socioeconomic status is a huge determinant. Level of education may be more important than income if the person lacks the health literacy to navigate the system and access needed care. Housing instability may include poor sanitation, substandard dwellings, or unsafe neighborhoods – all of which can affect a person’s well-being. Environmental health may include compromised air quality – which can impact pulmonary health. Other issues include access to employment and child care, utility needs, and interpersonal violence.
A 2014 paper in Annals of Internal Medicine found that residence within a disadvantaged neighborhood was a factor in hospital readmission rates as often as was chronic pulmonary disease.4 A recent report on social determinants of health by the National Institute for Health Care Management notes that patients with food insecurity are 2.4 times more likely to go to the emergency room, while those with transportation needs are 2.6 times more likely.5
What can health care leaders do to better equip their clinicians and teams to help patients deal with this array of complex needs? Intermountain Healthcare, based in Salt Lake City, spearheaded in 2018 the development of the Alliance for the Determinants of Health, starting in the communities of Ogden and St. George, Utah. The Alliance seeks to promote health, improve access to care, and decrease health care costs through a charitable contribution of $12 million over 3 years to seed collaborative demonstration projects.
Lisa Nichols, assistant vice president for community health at Intermountain, said that, while hospitalists were not directly involved in planning the Alliance, hospitalists and ED physicians have become essential to the patient-screening process for health and social needs.
“We met with hospitalists, emergency departments, and hospital administrators, because we wanted their feedback on how to raise awareness of the social needs of patients,” she said. “They have good ideas. They see the patients who come in from the homeless shelters.”
Other hospitals are subsidizing apartments for homeless patients being discharged from the hospital. CommonSpirit Health, the new national Catholic health care organization formed by the 2019 merger of Dignity Health and Catholic Health Initiatives, has explored how to help create and sustain affordable housing in the communities it serves. Investments like this have inspired others, such as Kaiser Permanente, to get involved in supporting housing initiatives.6
Comprehensive community care
David Meltzer, MD, PhD, a hospitalist and professor of medicine at the University of Chicago, said most hospitalists these days believe social determinants of health are part of their job responsibilities.
“That’s not to say we all do it well. We may fail at addressing some of the barriers our patients face. But I don’t know anyone who still says it’s not their job,” he said.
Since 2012, Dr. Meltzer has led a pilot called Comprehensive Care Physicians (CCP), in which the same physician cares for patients with chronic health problems in the clinic and in the hospital, working with a team of nurse practitioners, social workers, care coordinators, and other specialists. A total of 2,000 patients with chronic health problems were enrolled in the study from 2012 to 2016, half assigned to standard care and half assigned to five CCP doctors. The result: The CCP model has shown large improvements in outcomes – particularly among the more vulnerable, less activated patients, is preferred by patients, and has significantly reduced health care utilization.
The next step for the research team is another randomized controlled trial called Comprehensive Care, Community, and Culture, designed to address unmet social needs. Study group patients will also be screened for unmet social needs and have access to a community health worker and to the initiative’s Artful Living Program, which includes community and cultural activities like yoga and dance classes, cooking classes, art classes, and music concerts. To address the complex dimensions and determinants of health, Dr. Meltzer explained, efforts to improve health must extend to sectors far beyond traditional health care.
“I think trying to understand your patients’ social and nonmedical needs starts with getting to know them, and asking about their needs,” he said. “The better you know them, the better you are able to make medical decisions that will promote positive outcomes.”
Sound Physicians, a national hospitalist company based in Tacoma, Wash., and working in 350 hospitals in 41 states, recently published a blog post on its website about the importance of social determinants of health.7 Sound Physicians participates in value-based care through bundled Medicare/Medicaid contracts based on episodes of care for hospitalized patients with certain diagnoses or DRGs, explained John Dickey, MD, the company’s chief medical officer for population health.
“We’ve been heavily involved in trying to improve cost and outcomes of care since 2015. Social determinants absolutely play into trying to lower costs of care and reduce rates of readmissions, which are often multifactorial in cause,” he said. Hospitalists are uniquely equipped to impact post-acute outcomes, Dr. Dickey said, working in partnership with a position Sound Physicians calls the clinical performance nurse.
“We can also partner with primary care providers, provide education for our hospitalist staff, and work with in-home care supports for patients such as these, who otherwise might end up in a skilled nursing facility – even though they’d rather be at home,” he said.
Innovations at Northwell Health
Northwell Health, a multihospital comprehensive health system serving the New York City metro area and Long Island, has shown innovative leadership in addressing social factors. The 23-hospital system initiated in early 2019 a 15-item Self-Reported Social Determinants Screening Tool, which is now used with hospitalized patients to connect them with the support they need to fully recover and avoid readmissions.
Northwell is also providing professional education on social determinants for different constituencies across its system, said Johanna Martinez, MD, MS, a hospitalist and GME Director of Diversity and Health Equity at the Zucker School of Medicine at Hofstra/Northwell. A day-long training retreat was offered to GME faculty, and learning platforms have been developed for physicians, social workers, nurses, and others.
“One of the questions that comes up is that if you find social needs, what do you do about them?” Dr. Martinez explained. That’s more a difficult challenge, she said, so at Northwell, orthopedic surgeons are now asking patients questions like: “What’s going to happen when you go home? What are your social supports? Can you get to the physical therapist’s office?”
Another example of Northwell’s innovations is its Food as Health Program, initially piloted at Long Island Jewish Hospital in Valley Stream, N.Y. Hospitalized patients are asked two questions using a validated screening tool called the Hunger Vital Sign to identify their food insecurities.8 Those who answer yes are referred to a dietitian, and if they have a nutrition-related diagnosis, they enter the multidisciplinary wraparound program.
A key element is the food and health center, located on the hospital campus, where they can get food to take home and referrals to other services, with culturally tailored, disease-specific food education incorporated into the discharge plan. One of the partnering organizations is Island Harvest Food Bank, which helps about 1 in every 10 residents of Long Island with their food insecurity issues.
“When I talk to clinicians, most of us went into medicine to save lives and cure people. Yet the research shows that no matter who we are, we can’t do the best work that our patients need unless we consider their social determinants,” Dr. Martinez said. Ultimately, she noted, there is a need to change the culture of health care. “We have to create system change, reimbursement change, policy change.”
Omolara Uwemedimo, MD, MPH, associate professor of pediatrics and occupational medicine at Northwell and a former nocturnist, said the treatment of illness and health improvement don’t begin in the hospital, they begin in the community. Identifying where people are struggling and what communities they come from requires a broader view of the provider’s role. “Are patients who are readmitted to the hospital generally coming from certain demographics or from certain zip codes?” she asked. “Start there. How can we better connect with those communities?”
Education is key
In 2020 and beyond, hospitalists will hear more about the social determinants of health, Dr. Jacobs-Shaw concluded. “Without addressing those social determinants, we aren’t going to be able to meaningfully impact outcomes or be effective stewards of health care costs – addressing the psychosocial factors and root causes of patients coming in and out of the hospital.”
He added that self-education is key for hospitalists and the teams they work with – to be more aware of the link between health outcomes and social determinants. Guidelines and other resources on social determinants of health are available from the American College of Physicians and the American Association of Family Physicians. ACP issued a position paper on addressing social determinants of health to improve patient care,while AAFP has a research page on its website dedicated to social determinants of health, highlighting a number of initiatives and resources for physicians and others.9
The American Hospital Association has produced fact sheets on ICD-10CM code categories for social determinants of health, including 11 ICD-10 “Z” codes, numbered Z55-Z65, which can be used for coding interventions to address social determinants of health. Other experts are looking at how to adapt the electronic health record to capture sociodemographic and behavioral factors, and then trigger referrals to resources in the hospital and the broader community, and how to mobilize artificial intelligence and machine learning to better identify social needs.
“Our doctors really want to be able to take care of the whole patient, while being stewards of health care resources. But sometimes we feel powerless and wonder how we can have a bigger impact on people, on populations” Dr. Jacobs-Shaw said. “Remember it only takes one voice within an organization to start to elevate this topic.”
References
1. Rappleye E. Physicians say social determinants of health are not their responsibility. Becker’s Hospital Review. 2018 May 15.
2. Robert Wood Johnson Foundation, University of Wisconsin Population Health Institute. County Health Rankings, 2014.
3. Freeman, GA. The extensivist model. Health Leaders Magazine, 2016 Sep 15.
4. Kind AJ et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: A retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74.
5. National Institute for Health Care Management. Addressing social determinants of health can improve community health & reduce costs.
6. Vial PB. Boundless collaboration: A philosophy for sustainable and stabilizing housing investment strategies. Health Progress: Journal of the Catholic Health Association of the United States. September-October 2019.
7. Social determinants of health: New solutions for growing complexities. Op-Med, a blog by Sound Physicians. 2019 Aug 1.
8. The hunger vital sign: A new standard of care for preventive health.
9. Daniel H et al. Addressing social determinants to improve patient care and promote health equity: An American College of Physicians position paper. Ann Intern Med. 2018;168:557-578.
Choice of infant sleep location is multifactorial
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
FROM PEDIATRICS
‘Antibacterial’ soap labels still list banned ingredients
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.