Guidelines

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects hair follicles, with predilection for intertriginous sites. The prevalence of HS ranges from 0.1% to 2%, with HS significantly affecting the quality of life for patients, with both physical and emotional consequences.

Guidelines from the U.S. and Canadian Hidradenitis Suppurativa Foundations provide a summary of management and treatment for patients.
 

Grading

Hurley staging is recommended to determine therapies. Stage I is classified by recurrent nodules and abscesses with minimal scars. Stage II is classified by one or a limited number of sinuses and/or scarring within a body region. Stage III is classified by multiple or extensive sinuses and/or scarring. The Dermatology Life Quality Index and pain visual analog scale scores can be used in addition to the Hurley staging for management.

Diagnostic testing/comorbidities screening

There is limited evidence for microbiological testing for HS because skin flora is the main bacteria cultured. Patients should be screened for smoking use, diabetes, metabolic syndrome, depression/anxiety, follicular occlusion tetrad, and squamous cell carcinoma. Some studies have suggested an association between the severity of HS and smoking; therefore, smoking cessation is recommended. Patients should also be counseled on weight loss.

Zinc supplementation (90 mg daily) may be helpful. However, there is insufficient evidence for recommendations to avoid diary, brewer’s yeast, friction, deodorant, depilation, or shaving. There is also insufficient data to support vitamin D supplementation.
 

Topical/intralesional therapies

Expert opinion supports the use of chlorhexidine, benzoyl peroxide, or zinc pyrithione. A keratolytic and antiseptic cream such as resorcinol 15% cream may be used but can cause contact dermatitis. Topical clindamycin may decrease pustules formation, but it can increase resistance to Staphylococcus aureus. Triamcinolone intravlesional injections may decrease inflamed HS lesions in the short term.

Systemic antibiotics

Systemic antibiotics have been used for decades to treat HS. Tetracyclines for a 12-week course or long-term maintenance can be used in mild to moderate HS. Clindamycin and rifampin combination can be used as second-line therapy for mild to moderate HS. Moxifloxacin, metronidazole, and rifampin combination can also be considered second-line treatment for moderate to severe disease. Dapsone can be used in patients with Hurley stage I or II for maintenance therapy. Ertapenem IV can be used as a rescue or as bridge therapy for severe disease.

The duration of antibiotics and frequency of use depends on each patient and resistance.

Hormonal agents and retinoids

Although androgens may influence HS, evidence for hormonal agents is limited. Hormonal agents, such as ethinyl estradiol and spironolactone, can be considered for females with mild to moderate HS. Retinoids may be considered as a second- or third-line agent, especially in patients with severe acne and HS.

Immunosuppressants and biologics

Immunosuppressants such as methotrexate and azathioprine provide limited benefit; therefore, they are not recommended. Colchicine with minocycline may provide slight benefit in refractory mild to moderate HS. Cyclosporine may be considered in recalcitrant, severe HS. Systemic corticosteroids can be used short term for acute flares or long term for severe HS.

Biologic therapy is becoming more common and the choice of therapy for moderate to severe HS. Adalimumab is currently the only Food and Drug Administration–approved tumor necrosis factor–inhibitor treatment for HS. Other biologics – including infliximab, anakinra, and ustekinumab – may be effective for HS, but optimal dosing needs to be determined.
 

Pain management

While there are no studies about pain in HS, acute pain management should include topical analgesics and oral nonsteroidal anti-inflammatory drugs. Anticonvulsants such as pregabalin or gabapentin may help with neuropathic pain, and opioids can be considered if there is no improvement with first-line agents.

Surgical management

Recurrent nodules and tunnels can be deroofed or excised. Acute abscesses may be relieved by incision and drainage. Extensive lesions may require wide local scalpel excision, carbon dioxide laser excision, or electrosurgical excision. Surgery alone does not affect the biology of HS; therefore, surgical interventions should be reserved for disease that is not managed by medical therapy.

The bottom line

HS is a chronic inflammatory condition with complex medical management and surgical treatment options. Hurley staging I-III can be used to grade severity and determine therapy. Management of pain, tobacco cessation, weight loss, and mental health are important aspects of HS. Zinc supplementation (90 mg daily) may be helpful. Experts opinion supports the use of chlorhexidine, benzoyl peroxide or zinc pyrithione.

Acute lesions may be managed with short-term oral or intralesional corticosteroids, as well as deroofing or incision and drainage. Moderate-to-severe HS may be managed with systemic antibiotics or biologics and surgical therapy. Adalimumab is the only FDA-approved biologic for treatment of HS.

Dr. Chuong is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations. Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90.

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication form the United States and Canadian Hidradenitis Suppurativa Foundations. Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019 Jul;81(1):91-101.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects hair follicles, with predilection for intertriginous sites. The prevalence of HS ranges from 0.1% to 2%, with HS significantly affecting the quality of life for patients, with both physical and emotional consequences.

Guidelines from the U.S. and Canadian Hidradenitis Suppurativa Foundations provide a summary of management and treatment for patients.
 

Grading

Hurley staging is recommended to determine therapies. Stage I is classified by recurrent nodules and abscesses with minimal scars. Stage II is classified by one or a limited number of sinuses and/or scarring within a body region. Stage III is classified by multiple or extensive sinuses and/or scarring. The Dermatology Life Quality Index and pain visual analog scale scores can be used in addition to the Hurley staging for management.

Diagnostic testing/comorbidities screening

There is limited evidence for microbiological testing for HS because skin flora is the main bacteria cultured. Patients should be screened for smoking use, diabetes, metabolic syndrome, depression/anxiety, follicular occlusion tetrad, and squamous cell carcinoma. Some studies have suggested an association between the severity of HS and smoking; therefore, smoking cessation is recommended. Patients should also be counseled on weight loss.

Zinc supplementation (90 mg daily) may be helpful. However, there is insufficient evidence for recommendations to avoid diary, brewer’s yeast, friction, deodorant, depilation, or shaving. There is also insufficient data to support vitamin D supplementation.
 

Topical/intralesional therapies

Expert opinion supports the use of chlorhexidine, benzoyl peroxide, or zinc pyrithione. A keratolytic and antiseptic cream such as resorcinol 15% cream may be used but can cause contact dermatitis. Topical clindamycin may decrease pustules formation, but it can increase resistance to Staphylococcus aureus. Triamcinolone intravlesional injections may decrease inflamed HS lesions in the short term.

Systemic antibiotics

Systemic antibiotics have been used for decades to treat HS. Tetracyclines for a 12-week course or long-term maintenance can be used in mild to moderate HS. Clindamycin and rifampin combination can be used as second-line therapy for mild to moderate HS. Moxifloxacin, metronidazole, and rifampin combination can also be considered second-line treatment for moderate to severe disease. Dapsone can be used in patients with Hurley stage I or II for maintenance therapy. Ertapenem IV can be used as a rescue or as bridge therapy for severe disease.

The duration of antibiotics and frequency of use depends on each patient and resistance.

Hormonal agents and retinoids

Although androgens may influence HS, evidence for hormonal agents is limited. Hormonal agents, such as ethinyl estradiol and spironolactone, can be considered for females with mild to moderate HS. Retinoids may be considered as a second- or third-line agent, especially in patients with severe acne and HS.

Immunosuppressants and biologics

Immunosuppressants such as methotrexate and azathioprine provide limited benefit; therefore, they are not recommended. Colchicine with minocycline may provide slight benefit in refractory mild to moderate HS. Cyclosporine may be considered in recalcitrant, severe HS. Systemic corticosteroids can be used short term for acute flares or long term for severe HS.

Biologic therapy is becoming more common and the choice of therapy for moderate to severe HS. Adalimumab is currently the only Food and Drug Administration–approved tumor necrosis factor–inhibitor treatment for HS. Other biologics – including infliximab, anakinra, and ustekinumab – may be effective for HS, but optimal dosing needs to be determined.
 

Pain management

While there are no studies about pain in HS, acute pain management should include topical analgesics and oral nonsteroidal anti-inflammatory drugs. Anticonvulsants such as pregabalin or gabapentin may help with neuropathic pain, and opioids can be considered if there is no improvement with first-line agents.

Surgical management

Recurrent nodules and tunnels can be deroofed or excised. Acute abscesses may be relieved by incision and drainage. Extensive lesions may require wide local scalpel excision, carbon dioxide laser excision, or electrosurgical excision. Surgery alone does not affect the biology of HS; therefore, surgical interventions should be reserved for disease that is not managed by medical therapy.

The bottom line

HS is a chronic inflammatory condition with complex medical management and surgical treatment options. Hurley staging I-III can be used to grade severity and determine therapy. Management of pain, tobacco cessation, weight loss, and mental health are important aspects of HS. Zinc supplementation (90 mg daily) may be helpful. Experts opinion supports the use of chlorhexidine, benzoyl peroxide or zinc pyrithione.

Acute lesions may be managed with short-term oral or intralesional corticosteroids, as well as deroofing or incision and drainage. Moderate-to-severe HS may be managed with systemic antibiotics or biologics and surgical therapy. Adalimumab is the only FDA-approved biologic for treatment of HS.

Dr. Chuong is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations. Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90.

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication form the United States and Canadian Hidradenitis Suppurativa Foundations. Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019 Jul;81(1):91-101.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects hair follicles, with predilection for intertriginous sites. The prevalence of HS ranges from 0.1% to 2%, with HS significantly affecting the quality of life for patients, with both physical and emotional consequences.

Guidelines from the U.S. and Canadian Hidradenitis Suppurativa Foundations provide a summary of management and treatment for patients.
 

Grading

Hurley staging is recommended to determine therapies. Stage I is classified by recurrent nodules and abscesses with minimal scars. Stage II is classified by one or a limited number of sinuses and/or scarring within a body region. Stage III is classified by multiple or extensive sinuses and/or scarring. The Dermatology Life Quality Index and pain visual analog scale scores can be used in addition to the Hurley staging for management.

Diagnostic testing/comorbidities screening

There is limited evidence for microbiological testing for HS because skin flora is the main bacteria cultured. Patients should be screened for smoking use, diabetes, metabolic syndrome, depression/anxiety, follicular occlusion tetrad, and squamous cell carcinoma. Some studies have suggested an association between the severity of HS and smoking; therefore, smoking cessation is recommended. Patients should also be counseled on weight loss.

Zinc supplementation (90 mg daily) may be helpful. However, there is insufficient evidence for recommendations to avoid diary, brewer’s yeast, friction, deodorant, depilation, or shaving. There is also insufficient data to support vitamin D supplementation.
 

Topical/intralesional therapies

Expert opinion supports the use of chlorhexidine, benzoyl peroxide, or zinc pyrithione. A keratolytic and antiseptic cream such as resorcinol 15% cream may be used but can cause contact dermatitis. Topical clindamycin may decrease pustules formation, but it can increase resistance to Staphylococcus aureus. Triamcinolone intravlesional injections may decrease inflamed HS lesions in the short term.

Systemic antibiotics

Systemic antibiotics have been used for decades to treat HS. Tetracyclines for a 12-week course or long-term maintenance can be used in mild to moderate HS. Clindamycin and rifampin combination can be used as second-line therapy for mild to moderate HS. Moxifloxacin, metronidazole, and rifampin combination can also be considered second-line treatment for moderate to severe disease. Dapsone can be used in patients with Hurley stage I or II for maintenance therapy. Ertapenem IV can be used as a rescue or as bridge therapy for severe disease.

The duration of antibiotics and frequency of use depends on each patient and resistance.

Hormonal agents and retinoids

Although androgens may influence HS, evidence for hormonal agents is limited. Hormonal agents, such as ethinyl estradiol and spironolactone, can be considered for females with mild to moderate HS. Retinoids may be considered as a second- or third-line agent, especially in patients with severe acne and HS.

Immunosuppressants and biologics

Immunosuppressants such as methotrexate and azathioprine provide limited benefit; therefore, they are not recommended. Colchicine with minocycline may provide slight benefit in refractory mild to moderate HS. Cyclosporine may be considered in recalcitrant, severe HS. Systemic corticosteroids can be used short term for acute flares or long term for severe HS.

Biologic therapy is becoming more common and the choice of therapy for moderate to severe HS. Adalimumab is currently the only Food and Drug Administration–approved tumor necrosis factor–inhibitor treatment for HS. Other biologics – including infliximab, anakinra, and ustekinumab – may be effective for HS, but optimal dosing needs to be determined.
 

Pain management

While there are no studies about pain in HS, acute pain management should include topical analgesics and oral nonsteroidal anti-inflammatory drugs. Anticonvulsants such as pregabalin or gabapentin may help with neuropathic pain, and opioids can be considered if there is no improvement with first-line agents.

Surgical management

Recurrent nodules and tunnels can be deroofed or excised. Acute abscesses may be relieved by incision and drainage. Extensive lesions may require wide local scalpel excision, carbon dioxide laser excision, or electrosurgical excision. Surgery alone does not affect the biology of HS; therefore, surgical interventions should be reserved for disease that is not managed by medical therapy.

The bottom line

HS is a chronic inflammatory condition with complex medical management and surgical treatment options. Hurley staging I-III can be used to grade severity and determine therapy. Management of pain, tobacco cessation, weight loss, and mental health are important aspects of HS. Zinc supplementation (90 mg daily) may be helpful. Experts opinion supports the use of chlorhexidine, benzoyl peroxide or zinc pyrithione.

Acute lesions may be managed with short-term oral or intralesional corticosteroids, as well as deroofing or incision and drainage. Moderate-to-severe HS may be managed with systemic antibiotics or biologics and surgical therapy. Adalimumab is the only FDA-approved biologic for treatment of HS.

Dr. Chuong is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations. Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90.

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication form the United States and Canadian Hidradenitis Suppurativa Foundations. Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019 Jul;81(1):91-101.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

The American College of Cardiology on Feb. 13, 2020, released a clinical bulletin that aims to address cardiac implications of the current epidemic of the novel coronavirus, now known as COVID-19.

The bulletin, reviewed and approved by the college’s Science and Quality Oversight Committee, “provides background on the epidemic, which was first reported in late December 2019, and looks at early cardiac implications from case reports,” the ACC noted in a press release. “It also provides information on the potential cardiac implications from analog viral respiratory pandemics and offers early clinical guidance given current COVID-19 uncertainty.”

The document looks at some early cardiac implications of the infection. For example, early case reports suggest patients with underlying conditions are at higher risk of complications or mortality from the virus, with up to 50% of hospitalized patients having a chronic medical illness, the authors wrote.

About 40% of hospitalized patients confirmed to have the virus have cardiovascular or cerebrovascular disease, they noted.

In a recent case report on 138 hospitalized COVID-19 patients, they noted, 19.6% developed acute respiratory distress syndrome, 16.7% developed arrhythmia, 8.7% developed shock, 7.2% developed acute cardiac injury, and 3.6% developed acute kidney injury. “Rates of complication were universally higher for ICU patients,” they wrote.

“The first reported death was a 61-year-old male, with a long history of smoking, who succumbed to acute respiratory distress, heart failure, and cardiac arrest,” the document noted. “Early, unpublished first-hand reports suggest at least some patients develop myocarditis.”

Stressing the current uncertainty about the virus, the bulletin provides the following clinical guidance:

• COVID-19 is spread through droplets and can live for substantial periods outside the body; containment and prevention using standard public health and personal strategies for preventing the spread of communicable disease remains the priority.
• In geographies with active COVID-19 transmission (mainly China), it is reasonable to advise patients with underlying cardiovascular disease of the potential increased risk and to encourage additional, reasonable precautions.
• Older adults are less likely to present with fever, thus close assessment for other symptoms such as cough or shortness of breath is warranted.
• Some experts have suggested that the rigorous use of guideline-directed, plaque-stabilizing agents could offer additional protection to cardiovascular disease (CVD) patients during a widespread outbreak (statins, beta-blockers, ACE inhibitors, acetylsalicylic acid); however, such therapies should be tailored to individual patients.
• It is important for patients with CVD to remain current with vaccinations, including the pneumococcal vaccine, given the increased risk of secondary bacterial infection; it would also be prudent to receive vaccination to prevent another source of fever which could be initially confused with coronavirus infection.
• It may be reasonable to triage COVID-19 patients according to the presence of underlying cardiovascular, respiratory, renal, and other chronic diseases for prioritized treatment.
• Providers are cautioned that classic symptoms and presentation of acute MI may be overshadowed in the context of coronavirus, resulting in underdiagnosis.
• For CVD patients in geographies without widespread COVID-19, emphasis should remain on the threat from influenza, the importance of vaccination and frequent handwashing, and continued adherence to all guideline-directed therapy for underlying chronic conditions.
• COVID-19 is a fast-moving epidemic with an uncertain clinical profile; providers should be prepared for guidance to shift as more information becomes available.

The full clinical update is available here.

This article first appeared on Medscape.com.

The American College of Cardiology on Feb. 13, 2020, released a clinical bulletin that aims to address cardiac implications of the current epidemic of the novel coronavirus, now known as COVID-19.

The bulletin, reviewed and approved by the college’s Science and Quality Oversight Committee, “provides background on the epidemic, which was first reported in late December 2019, and looks at early cardiac implications from case reports,” the ACC noted in a press release. “It also provides information on the potential cardiac implications from analog viral respiratory pandemics and offers early clinical guidance given current COVID-19 uncertainty.”

The document looks at some early cardiac implications of the infection. For example, early case reports suggest patients with underlying conditions are at higher risk of complications or mortality from the virus, with up to 50% of hospitalized patients having a chronic medical illness, the authors wrote.

About 40% of hospitalized patients confirmed to have the virus have cardiovascular or cerebrovascular disease, they noted.

In a recent case report on 138 hospitalized COVID-19 patients, they noted, 19.6% developed acute respiratory distress syndrome, 16.7% developed arrhythmia, 8.7% developed shock, 7.2% developed acute cardiac injury, and 3.6% developed acute kidney injury. “Rates of complication were universally higher for ICU patients,” they wrote.

“The first reported death was a 61-year-old male, with a long history of smoking, who succumbed to acute respiratory distress, heart failure, and cardiac arrest,” the document noted. “Early, unpublished first-hand reports suggest at least some patients develop myocarditis.”

Stressing the current uncertainty about the virus, the bulletin provides the following clinical guidance:

• COVID-19 is spread through droplets and can live for substantial periods outside the body; containment and prevention using standard public health and personal strategies for preventing the spread of communicable disease remains the priority.
• In geographies with active COVID-19 transmission (mainly China), it is reasonable to advise patients with underlying cardiovascular disease of the potential increased risk and to encourage additional, reasonable precautions.
• Older adults are less likely to present with fever, thus close assessment for other symptoms such as cough or shortness of breath is warranted.
• Some experts have suggested that the rigorous use of guideline-directed, plaque-stabilizing agents could offer additional protection to cardiovascular disease (CVD) patients during a widespread outbreak (statins, beta-blockers, ACE inhibitors, acetylsalicylic acid); however, such therapies should be tailored to individual patients.
• It is important for patients with CVD to remain current with vaccinations, including the pneumococcal vaccine, given the increased risk of secondary bacterial infection; it would also be prudent to receive vaccination to prevent another source of fever which could be initially confused with coronavirus infection.
• It may be reasonable to triage COVID-19 patients according to the presence of underlying cardiovascular, respiratory, renal, and other chronic diseases for prioritized treatment.
• Providers are cautioned that classic symptoms and presentation of acute MI may be overshadowed in the context of coronavirus, resulting in underdiagnosis.
• For CVD patients in geographies without widespread COVID-19, emphasis should remain on the threat from influenza, the importance of vaccination and frequent handwashing, and continued adherence to all guideline-directed therapy for underlying chronic conditions.
• COVID-19 is a fast-moving epidemic with an uncertain clinical profile; providers should be prepared for guidance to shift as more information becomes available.

The full clinical update is available here.

This article first appeared on Medscape.com.

The American College of Cardiology on Feb. 13, 2020, released a clinical bulletin that aims to address cardiac implications of the current epidemic of the novel coronavirus, now known as COVID-19.

The bulletin, reviewed and approved by the college’s Science and Quality Oversight Committee, “provides background on the epidemic, which was first reported in late December 2019, and looks at early cardiac implications from case reports,” the ACC noted in a press release. “It also provides information on the potential cardiac implications from analog viral respiratory pandemics and offers early clinical guidance given current COVID-19 uncertainty.”

The document looks at some early cardiac implications of the infection. For example, early case reports suggest patients with underlying conditions are at higher risk of complications or mortality from the virus, with up to 50% of hospitalized patients having a chronic medical illness, the authors wrote.

About 40% of hospitalized patients confirmed to have the virus have cardiovascular or cerebrovascular disease, they noted.

In a recent case report on 138 hospitalized COVID-19 patients, they noted, 19.6% developed acute respiratory distress syndrome, 16.7% developed arrhythmia, 8.7% developed shock, 7.2% developed acute cardiac injury, and 3.6% developed acute kidney injury. “Rates of complication were universally higher for ICU patients,” they wrote.

“The first reported death was a 61-year-old male, with a long history of smoking, who succumbed to acute respiratory distress, heart failure, and cardiac arrest,” the document noted. “Early, unpublished first-hand reports suggest at least some patients develop myocarditis.”

Stressing the current uncertainty about the virus, the bulletin provides the following clinical guidance:

• COVID-19 is spread through droplets and can live for substantial periods outside the body; containment and prevention using standard public health and personal strategies for preventing the spread of communicable disease remains the priority.
• In geographies with active COVID-19 transmission (mainly China), it is reasonable to advise patients with underlying cardiovascular disease of the potential increased risk and to encourage additional, reasonable precautions.
• Older adults are less likely to present with fever, thus close assessment for other symptoms such as cough or shortness of breath is warranted.
• Some experts have suggested that the rigorous use of guideline-directed, plaque-stabilizing agents could offer additional protection to cardiovascular disease (CVD) patients during a widespread outbreak (statins, beta-blockers, ACE inhibitors, acetylsalicylic acid); however, such therapies should be tailored to individual patients.
• It is important for patients with CVD to remain current with vaccinations, including the pneumococcal vaccine, given the increased risk of secondary bacterial infection; it would also be prudent to receive vaccination to prevent another source of fever which could be initially confused with coronavirus infection.
• It may be reasonable to triage COVID-19 patients according to the presence of underlying cardiovascular, respiratory, renal, and other chronic diseases for prioritized treatment.
• Providers are cautioned that classic symptoms and presentation of acute MI may be overshadowed in the context of coronavirus, resulting in underdiagnosis.
• For CVD patients in geographies without widespread COVID-19, emphasis should remain on the threat from influenza, the importance of vaccination and frequent handwashing, and continued adherence to all guideline-directed therapy for underlying chronic conditions.
• COVID-19 is a fast-moving epidemic with an uncertain clinical profile; providers should be prepared for guidance to shift as more information becomes available.

The full clinical update is available here.

This article first appeared on Medscape.com.

The American Academy of Neurology (AAN) has issued a new guideline for the treatment of sleep problems in children and teenagers with autism spectrum disorders (ASD). The guideline was published online ahead of print Feb. 12 in Neurology.

“While up to 40% of children and teens in the general population will have sleep problems at some point during their childhood, such problems usually lessen with age,” lead author Ashura Williams Buckley, MD, director of the Sleep and Neurodevelopment Service at the National Institute of Mental Health in Bethesda, Md., said in a press release. “For children and teens with autism, sleep problems are more common and more likely to persist, resulting in poor health and poor quality of life. Some sleep problems may be directly related to autism, but others are not. Regardless, autism symptoms may make sleep problems worse.”
 

Few evidence-based treatments are available

Dr. Williams Buckley and colleagues developed the current guideline to evaluate which pharmacologic, behavioral, and complementary and alternative medicine (CAM) interventions improve bedtime resistance, sleep onset latency, sleep continuity, total sleep time, and daytime behavior in children and adolescents with ASD. The panel evaluated 900 abstracts of articles that had been included in systematic reviews, as well as 1,087 additional abstracts. One hundred thirty-nine articles were potentially relevant, 12 met criteria for data extraction, and eight were rated class III or higher and were included in the panel’s review.

The authors observed what they called a dearth of evidence-based treatments for sleep dysregulation in ASD. Evidence indicates that melatonin, with or without cognitive–behavioral therapy (CBT), improves several sleep outcomes, compared with placebo. “Evidence for other interventions is largely lacking,” wrote Dr. Williams Buckley and colleagues. They observed a lack of long-term safety data for melatonin in children, which they considered concerning, because melatonin affects the hypothalamic–gonadal axis and can potentially influence pubertal development.
 

Screening for comorbid conditions and concomitant medications

The guideline recommends that clinicians assess children with ASD and sleep disturbances for coexisting conditions and concomitant medications that could be contributing to these sleep disturbances. They should ensure that children receive appropriate treatment for coexisting conditions and adjust or discontinue potentially problematic medications appropriately, according to the guideline.

Furthermore, clinicians should counsel parents or guardians about behavioral strategies as a first-line treatment for improving sleep function. These strategies could be administered alone or with pharmacologic or neutraceutical approaches as needed, according to the authors. Suggested behavioral approaches include unmodified extinction (i.e., imposing a bedtime and ignoring a child’s protests), graduated extinction (i.e., ignoring protests for a specified period before responding), positive routines (i.e., establishing pre-bedtime calming rituals), and bedtime fading (i.e., putting a child to bed close to the time he or she begins to fall asleep).

If a child’s contributing coexisting conditions and medications have been addressed and behavioral strategies have not been helpful, clinicians should offer melatonin, according to the guideline. Because over-the-counter formulations contain variable concentrations of melatonin, clinicians should write a prescription for it or recommend high-purity pharmaceutical grade melatonin. The initial dose should be 1-3 mg/day at 60-30 minutes before bedtime. The dose can be titrated to 10 mg/day. Clinicians also should counsel children and their parents about potential adverse events of melatonin and the lack of long-term safety data, according to the guideline.

In addition, clinicians should advise children and parents that no evidence supports the routine use of weighted blankets or specialized mattress technology for improving sleep. Parents who ask about weighted blankets should be told that the reviewed trial reported no serious adverse events with this intervention, and that blankets could be a reasonable nonpharmacologic approach for some patients, according to the guideline.
 

Optimal outcome measures are undefined

Dr. Williams Buckley and colleagues also suggested areas for future research. Investigators have not yet defined optimal outcome measures (e.g., questionnaires, polysomnography, and actigraphy) that balance tolerability and accuracy, they wrote. Clinically important differences for most measures also have yet to be determined. Researchers should investigate whether long-term adverse events are associated with chronic melatonin use and study patients with ASD and comorbid mood disorders, wrote the authors. “Research tying the underlying neurobiology in early-life sleep disruption to behavior might help clinicians and researchers understand which treatments might work for which people with ASD,” they concluded.

The AAN supported the development of the guideline. Dr. Williams Buckley had no conflicts of interest. Six authors had conflicts of interest that the AAN deemed not significant enough to prevent their participation in the development of the guideline.

[email protected]

SOURCE: Williams Buckley A et al. Neurology. 2020;94:393-405. doi: 10.1212/WNL0000000000009033.

The American Academy of Neurology (AAN) has issued a new guideline for the treatment of sleep problems in children and teenagers with autism spectrum disorders (ASD). The guideline was published online ahead of print Feb. 12 in Neurology.

“While up to 40% of children and teens in the general population will have sleep problems at some point during their childhood, such problems usually lessen with age,” lead author Ashura Williams Buckley, MD, director of the Sleep and Neurodevelopment Service at the National Institute of Mental Health in Bethesda, Md., said in a press release. “For children and teens with autism, sleep problems are more common and more likely to persist, resulting in poor health and poor quality of life. Some sleep problems may be directly related to autism, but others are not. Regardless, autism symptoms may make sleep problems worse.”
 

Few evidence-based treatments are available

Dr. Williams Buckley and colleagues developed the current guideline to evaluate which pharmacologic, behavioral, and complementary and alternative medicine (CAM) interventions improve bedtime resistance, sleep onset latency, sleep continuity, total sleep time, and daytime behavior in children and adolescents with ASD. The panel evaluated 900 abstracts of articles that had been included in systematic reviews, as well as 1,087 additional abstracts. One hundred thirty-nine articles were potentially relevant, 12 met criteria for data extraction, and eight were rated class III or higher and were included in the panel’s review.

The authors observed what they called a dearth of evidence-based treatments for sleep dysregulation in ASD. Evidence indicates that melatonin, with or without cognitive–behavioral therapy (CBT), improves several sleep outcomes, compared with placebo. “Evidence for other interventions is largely lacking,” wrote Dr. Williams Buckley and colleagues. They observed a lack of long-term safety data for melatonin in children, which they considered concerning, because melatonin affects the hypothalamic–gonadal axis and can potentially influence pubertal development.
 

Screening for comorbid conditions and concomitant medications

The guideline recommends that clinicians assess children with ASD and sleep disturbances for coexisting conditions and concomitant medications that could be contributing to these sleep disturbances. They should ensure that children receive appropriate treatment for coexisting conditions and adjust or discontinue potentially problematic medications appropriately, according to the guideline.

Furthermore, clinicians should counsel parents or guardians about behavioral strategies as a first-line treatment for improving sleep function. These strategies could be administered alone or with pharmacologic or neutraceutical approaches as needed, according to the authors. Suggested behavioral approaches include unmodified extinction (i.e., imposing a bedtime and ignoring a child’s protests), graduated extinction (i.e., ignoring protests for a specified period before responding), positive routines (i.e., establishing pre-bedtime calming rituals), and bedtime fading (i.e., putting a child to bed close to the time he or she begins to fall asleep).

If a child’s contributing coexisting conditions and medications have been addressed and behavioral strategies have not been helpful, clinicians should offer melatonin, according to the guideline. Because over-the-counter formulations contain variable concentrations of melatonin, clinicians should write a prescription for it or recommend high-purity pharmaceutical grade melatonin. The initial dose should be 1-3 mg/day at 60-30 minutes before bedtime. The dose can be titrated to 10 mg/day. Clinicians also should counsel children and their parents about potential adverse events of melatonin and the lack of long-term safety data, according to the guideline.

In addition, clinicians should advise children and parents that no evidence supports the routine use of weighted blankets or specialized mattress technology for improving sleep. Parents who ask about weighted blankets should be told that the reviewed trial reported no serious adverse events with this intervention, and that blankets could be a reasonable nonpharmacologic approach for some patients, according to the guideline.
 

Optimal outcome measures are undefined

Dr. Williams Buckley and colleagues also suggested areas for future research. Investigators have not yet defined optimal outcome measures (e.g., questionnaires, polysomnography, and actigraphy) that balance tolerability and accuracy, they wrote. Clinically important differences for most measures also have yet to be determined. Researchers should investigate whether long-term adverse events are associated with chronic melatonin use and study patients with ASD and comorbid mood disorders, wrote the authors. “Research tying the underlying neurobiology in early-life sleep disruption to behavior might help clinicians and researchers understand which treatments might work for which people with ASD,” they concluded.

The AAN supported the development of the guideline. Dr. Williams Buckley had no conflicts of interest. Six authors had conflicts of interest that the AAN deemed not significant enough to prevent their participation in the development of the guideline.

[email protected]

SOURCE: Williams Buckley A et al. Neurology. 2020;94:393-405. doi: 10.1212/WNL0000000000009033.

The American Academy of Neurology (AAN) has issued a new guideline for the treatment of sleep problems in children and teenagers with autism spectrum disorders (ASD). The guideline was published online ahead of print Feb. 12 in Neurology.

“While up to 40% of children and teens in the general population will have sleep problems at some point during their childhood, such problems usually lessen with age,” lead author Ashura Williams Buckley, MD, director of the Sleep and Neurodevelopment Service at the National Institute of Mental Health in Bethesda, Md., said in a press release. “For children and teens with autism, sleep problems are more common and more likely to persist, resulting in poor health and poor quality of life. Some sleep problems may be directly related to autism, but others are not. Regardless, autism symptoms may make sleep problems worse.”
 

Few evidence-based treatments are available

Dr. Williams Buckley and colleagues developed the current guideline to evaluate which pharmacologic, behavioral, and complementary and alternative medicine (CAM) interventions improve bedtime resistance, sleep onset latency, sleep continuity, total sleep time, and daytime behavior in children and adolescents with ASD. The panel evaluated 900 abstracts of articles that had been included in systematic reviews, as well as 1,087 additional abstracts. One hundred thirty-nine articles were potentially relevant, 12 met criteria for data extraction, and eight were rated class III or higher and were included in the panel’s review.

The authors observed what they called a dearth of evidence-based treatments for sleep dysregulation in ASD. Evidence indicates that melatonin, with or without cognitive–behavioral therapy (CBT), improves several sleep outcomes, compared with placebo. “Evidence for other interventions is largely lacking,” wrote Dr. Williams Buckley and colleagues. They observed a lack of long-term safety data for melatonin in children, which they considered concerning, because melatonin affects the hypothalamic–gonadal axis and can potentially influence pubertal development.
 

Screening for comorbid conditions and concomitant medications

The guideline recommends that clinicians assess children with ASD and sleep disturbances for coexisting conditions and concomitant medications that could be contributing to these sleep disturbances. They should ensure that children receive appropriate treatment for coexisting conditions and adjust or discontinue potentially problematic medications appropriately, according to the guideline.

Furthermore, clinicians should counsel parents or guardians about behavioral strategies as a first-line treatment for improving sleep function. These strategies could be administered alone or with pharmacologic or neutraceutical approaches as needed, according to the authors. Suggested behavioral approaches include unmodified extinction (i.e., imposing a bedtime and ignoring a child’s protests), graduated extinction (i.e., ignoring protests for a specified period before responding), positive routines (i.e., establishing pre-bedtime calming rituals), and bedtime fading (i.e., putting a child to bed close to the time he or she begins to fall asleep).

If a child’s contributing coexisting conditions and medications have been addressed and behavioral strategies have not been helpful, clinicians should offer melatonin, according to the guideline. Because over-the-counter formulations contain variable concentrations of melatonin, clinicians should write a prescription for it or recommend high-purity pharmaceutical grade melatonin. The initial dose should be 1-3 mg/day at 60-30 minutes before bedtime. The dose can be titrated to 10 mg/day. Clinicians also should counsel children and their parents about potential adverse events of melatonin and the lack of long-term safety data, according to the guideline.

In addition, clinicians should advise children and parents that no evidence supports the routine use of weighted blankets or specialized mattress technology for improving sleep. Parents who ask about weighted blankets should be told that the reviewed trial reported no serious adverse events with this intervention, and that blankets could be a reasonable nonpharmacologic approach for some patients, according to the guideline.
 

Optimal outcome measures are undefined

Dr. Williams Buckley and colleagues also suggested areas for future research. Investigators have not yet defined optimal outcome measures (e.g., questionnaires, polysomnography, and actigraphy) that balance tolerability and accuracy, they wrote. Clinically important differences for most measures also have yet to be determined. Researchers should investigate whether long-term adverse events are associated with chronic melatonin use and study patients with ASD and comorbid mood disorders, wrote the authors. “Research tying the underlying neurobiology in early-life sleep disruption to behavior might help clinicians and researchers understand which treatments might work for which people with ASD,” they concluded.

The AAN supported the development of the guideline. Dr. Williams Buckley had no conflicts of interest. Six authors had conflicts of interest that the AAN deemed not significant enough to prevent their participation in the development of the guideline.

[email protected]

SOURCE: Williams Buckley A et al. Neurology. 2020;94:393-405. doi: 10.1212/WNL0000000000009033.

In new guidelines, the American Society of Clinical Oncology recommends offering germline genetic testing for BRCA1, BRCA2, and other ovarian cancer susceptibility genes to all women diagnosed with epithelial ovarian cancer, regardless of their clinical features or family history.

Testing should be offered at diagnosis or as soon as possible after that, Panagiotis A. Konstantinopoulos, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and colleagues wrote in the Journal of Clinical Oncology.

For patients who do not carry a germline pathogenic or likely pathogenic BRCA1/2 variant, the guidelines recommend offering somatic tumor testing for BRCA1/2 pathogenic or likely pathogenic variants. This testing can be offered at the time of disease recurrence after up-front therapy.

The guidelines also recommend somatic tumor testing for mismatch repair deficiency in patients diagnosed with clear cell, endometrioid, or mucinous ovarian cancer. This testing may be offered to patients with other histologic types of epithelial ovarian cancer as well.

Genetic testing, as well as genetic risk evaluation and counseling, should be offered to first- or second-degree blood relatives of a patient with ovarian cancer and a known germline pathogenic cancer susceptibility gene variant, according to the guidelines.

According to the guidelines, genetic evaluations should be conducted in cooperation with other health care providers who are “familiar with the diagnosis and management of hereditary cancer syndromes to determine the most appropriate testing strategy and discuss implications of the findings.”

Patients with identified germline or somatic pathogenic or likely pathogenic BRCA1/2 variants should receive treatments approved for them by the Food and Drug Administration, according to the guidelines. The authors note that patients with these variants have responded well to FDA-approved poly (ADP-ribose) polymerase inhibitors, including niraparib (Zejula), olaparib (Lynparza), and rucaparib (Rubraca).

The guidelines also state that mismatch repair deficiency qualifies for FDA-approved treatment, so patients with recurrent epithelial ovarian cancer and mismatch repair deficiency should receive FDA-approved treatments under their labeled indications.

The guidelines note that clinical decisions should not be based on a variant of uncertain significance. When a patient has such a variant, “clinical features and family history should inform clinical decision making,” according to the guidelines.

Dr. Konstantinopoulos and colleagues formulated the guidelines after reviewing data from 19 studies, including 6 meta-analyses; 11 randomized, controlled trials; and 2 observational studies.

The authors reported relationships with a range of pharmaceutical companies, including those that market drugs for epithelial ovarian cancer.

SOURCE: Konstantinopoulos PA et al. J Clin Oncol. 2020 Jan 27. doi: 10.1200/JCO.19.02960.

In new guidelines, the American Society of Clinical Oncology recommends offering germline genetic testing for BRCA1, BRCA2, and other ovarian cancer susceptibility genes to all women diagnosed with epithelial ovarian cancer, regardless of their clinical features or family history.

Testing should be offered at diagnosis or as soon as possible after that, Panagiotis A. Konstantinopoulos, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and colleagues wrote in the Journal of Clinical Oncology.

For patients who do not carry a germline pathogenic or likely pathogenic BRCA1/2 variant, the guidelines recommend offering somatic tumor testing for BRCA1/2 pathogenic or likely pathogenic variants. This testing can be offered at the time of disease recurrence after up-front therapy.

The guidelines also recommend somatic tumor testing for mismatch repair deficiency in patients diagnosed with clear cell, endometrioid, or mucinous ovarian cancer. This testing may be offered to patients with other histologic types of epithelial ovarian cancer as well.

Genetic testing, as well as genetic risk evaluation and counseling, should be offered to first- or second-degree blood relatives of a patient with ovarian cancer and a known germline pathogenic cancer susceptibility gene variant, according to the guidelines.

According to the guidelines, genetic evaluations should be conducted in cooperation with other health care providers who are “familiar with the diagnosis and management of hereditary cancer syndromes to determine the most appropriate testing strategy and discuss implications of the findings.”

Patients with identified germline or somatic pathogenic or likely pathogenic BRCA1/2 variants should receive treatments approved for them by the Food and Drug Administration, according to the guidelines. The authors note that patients with these variants have responded well to FDA-approved poly (ADP-ribose) polymerase inhibitors, including niraparib (Zejula), olaparib (Lynparza), and rucaparib (Rubraca).

The guidelines also state that mismatch repair deficiency qualifies for FDA-approved treatment, so patients with recurrent epithelial ovarian cancer and mismatch repair deficiency should receive FDA-approved treatments under their labeled indications.

The guidelines note that clinical decisions should not be based on a variant of uncertain significance. When a patient has such a variant, “clinical features and family history should inform clinical decision making,” according to the guidelines.

Dr. Konstantinopoulos and colleagues formulated the guidelines after reviewing data from 19 studies, including 6 meta-analyses; 11 randomized, controlled trials; and 2 observational studies.

The authors reported relationships with a range of pharmaceutical companies, including those that market drugs for epithelial ovarian cancer.

SOURCE: Konstantinopoulos PA et al. J Clin Oncol. 2020 Jan 27. doi: 10.1200/JCO.19.02960.

In new guidelines, the American Society of Clinical Oncology recommends offering germline genetic testing for BRCA1, BRCA2, and other ovarian cancer susceptibility genes to all women diagnosed with epithelial ovarian cancer, regardless of their clinical features or family history.

Testing should be offered at diagnosis or as soon as possible after that, Panagiotis A. Konstantinopoulos, MD, PhD, of the Dana-Farber Cancer Institute in Boston, and colleagues wrote in the Journal of Clinical Oncology.

For patients who do not carry a germline pathogenic or likely pathogenic BRCA1/2 variant, the guidelines recommend offering somatic tumor testing for BRCA1/2 pathogenic or likely pathogenic variants. This testing can be offered at the time of disease recurrence after up-front therapy.

The guidelines also recommend somatic tumor testing for mismatch repair deficiency in patients diagnosed with clear cell, endometrioid, or mucinous ovarian cancer. This testing may be offered to patients with other histologic types of epithelial ovarian cancer as well.

Genetic testing, as well as genetic risk evaluation and counseling, should be offered to first- or second-degree blood relatives of a patient with ovarian cancer and a known germline pathogenic cancer susceptibility gene variant, according to the guidelines.

According to the guidelines, genetic evaluations should be conducted in cooperation with other health care providers who are “familiar with the diagnosis and management of hereditary cancer syndromes to determine the most appropriate testing strategy and discuss implications of the findings.”

Patients with identified germline or somatic pathogenic or likely pathogenic BRCA1/2 variants should receive treatments approved for them by the Food and Drug Administration, according to the guidelines. The authors note that patients with these variants have responded well to FDA-approved poly (ADP-ribose) polymerase inhibitors, including niraparib (Zejula), olaparib (Lynparza), and rucaparib (Rubraca).

The guidelines also state that mismatch repair deficiency qualifies for FDA-approved treatment, so patients with recurrent epithelial ovarian cancer and mismatch repair deficiency should receive FDA-approved treatments under their labeled indications.

The guidelines note that clinical decisions should not be based on a variant of uncertain significance. When a patient has such a variant, “clinical features and family history should inform clinical decision making,” according to the guidelines.

Dr. Konstantinopoulos and colleagues formulated the guidelines after reviewing data from 19 studies, including 6 meta-analyses; 11 randomized, controlled trials; and 2 observational studies.

The authors reported relationships with a range of pharmaceutical companies, including those that market drugs for epithelial ovarian cancer.

SOURCE: Konstantinopoulos PA et al. J Clin Oncol. 2020 Jan 27. doi: 10.1200/JCO.19.02960.

The prevalence of abdominal aortic aneurysms (AAAs) is decreasing, thought to be caused by a decrease in smoking. But the risk of death if one ruptures is as high as 81%. So, screening is still an important part of preventive medicine.

When the abdominal aorta enlarges to greater than 3.0 cm, it is considered an aneurysm. Risk factors that can lead to an enlarged aorta include older age, male sex, smoking, history of AAA in a first-degree relative, hypertension, history of other aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, and hypercholesterolemia.

History of AAA in a first-degree relative puts patients at double the risk of developing an abdominal aortic aneurysm. Interestingly, diabetes has been associated with a reduced risk of AAA. People of African American, Asian, and Hispanic descent have a reduced risk of AAA.
 

Screening

Screening is performed using abdominal duplex ultrasound. It has high sensitivity (94%-100%) and specificity (98%-100%), is low cost, and has low risk to the patient. The U.S. Preventive Services Task Force breaks its screening recommendations into four categories:

1. Men aged 65-75 years who have ever smoked (at least 100 cigarettes in their lifetime): One-time screening (grade B, moderate net benefit).

2. Men aged 65-75 years who have never smoked: Selectively offer screening (grade C, small net benefit). “To determine whether this service is appropriate, patients and clinicians should consider the patient’s medical history, family history, other risk factors, and personal values.”

3. Women without a smoking history or family history of AAA: Do not perform screening (grade D, recommendation against the service).

4. Women aged 65-75 years who have a smoking history or family history of AAA: There is insufficient evidence on whether or not to screen for AAA (grade I, insufficient evidence).

To assess screening and treatment of AAAs, the USPSTF looked at four randomized, controlled trials largely focused on men older than 65 years. With the combined data, they found 246 men would need to be screened to prevent 1 AAA rupture, and 305 men would need to be screened to prevent 1 death from AAA.

The USPSTF does note that, while the risk of death is lower for elective AAA repair than ruptured AAA, there is still increased risk with elective surgery. In addition, increased screening and detection increases the rate of elective surgery. Overdiagnosis and overtreatment could represent a harm.
 

Treatment

Surgical repair of AAA in men depends on the size of the aneurysm and rate of growth.

For men, surgical repair is standard when the AAA reaches 5.5 cm or if the AAA is growing faster than 1.0 cm per year and is larger than 4.0 cm. For women, surgical repair is often recommended between 5.0 cm and 5.4 cm in size.

Surgical repair is not recommended for AAAs that are less than 5.0 cm because the annual risk of rupture is 0%-1% below 5.0 cm. The risk increases to 11% for aneurysms that are 5.0-5.9 cm in size.

There are two methods of surgical repair: endovascular aneurysm repair and open repair. Recommendations for the surveillance of AAA between 3.0 cm and 5.5 cm is regular ultrasound surveillance, with the interval becoming shorter as the aneurysm size becomes larger. Exact intervals differ from one guideline group to another.
 

Screening and treatment in women

While it is true that AAAs in women are more likely to rupture at smaller sizes than AAAs in men, the AAAs that rupture in women are more likely to rupture at an older age than AAAs rupture in men.

The prevalence of AAAs in women is thought to be one-sixth of the prevalence of men. In addition, women had a higher 30-day mortality after surgical repair. They also had higher rates of complications for elective surgical repair of AAAs.

For these reasons, it is unclear that the benefits of AAA screening and treatment in women outweigh the risks, and the USPSTF cannot come to a conclusive recommendation for women who have ever smoked or women who have a family history of AAA.

The USPSTF is able to state definitively that they do not recommend screening in women with no smoking history or family history of AAA.
 

Bottom line

The USPSTF recommends screening men aged 65-75 years who have ever smoked and selectively screening men aged 65-75 years with no smoking history. The USPSTF recommends against screening women aged 65-75 years who have never smoked and have no family history of AAA. There is insufficient evidence to either recommend for or against screening women aged 65-75 years who have smoked or have a family history of AAA.

Reference

Owens DK et al. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-18.

Dr. Sprogell is a second-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

The prevalence of abdominal aortic aneurysms (AAAs) is decreasing, thought to be caused by a decrease in smoking. But the risk of death if one ruptures is as high as 81%. So, screening is still an important part of preventive medicine.

When the abdominal aorta enlarges to greater than 3.0 cm, it is considered an aneurysm. Risk factors that can lead to an enlarged aorta include older age, male sex, smoking, history of AAA in a first-degree relative, hypertension, history of other aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, and hypercholesterolemia.

History of AAA in a first-degree relative puts patients at double the risk of developing an abdominal aortic aneurysm. Interestingly, diabetes has been associated with a reduced risk of AAA. People of African American, Asian, and Hispanic descent have a reduced risk of AAA.
 

Screening

Screening is performed using abdominal duplex ultrasound. It has high sensitivity (94%-100%) and specificity (98%-100%), is low cost, and has low risk to the patient. The U.S. Preventive Services Task Force breaks its screening recommendations into four categories:

1. Men aged 65-75 years who have ever smoked (at least 100 cigarettes in their lifetime): One-time screening (grade B, moderate net benefit).

2. Men aged 65-75 years who have never smoked: Selectively offer screening (grade C, small net benefit). “To determine whether this service is appropriate, patients and clinicians should consider the patient’s medical history, family history, other risk factors, and personal values.”

3. Women without a smoking history or family history of AAA: Do not perform screening (grade D, recommendation against the service).

4. Women aged 65-75 years who have a smoking history or family history of AAA: There is insufficient evidence on whether or not to screen for AAA (grade I, insufficient evidence).

To assess screening and treatment of AAAs, the USPSTF looked at four randomized, controlled trials largely focused on men older than 65 years. With the combined data, they found 246 men would need to be screened to prevent 1 AAA rupture, and 305 men would need to be screened to prevent 1 death from AAA.

The USPSTF does note that, while the risk of death is lower for elective AAA repair than ruptured AAA, there is still increased risk with elective surgery. In addition, increased screening and detection increases the rate of elective surgery. Overdiagnosis and overtreatment could represent a harm.
 

Treatment

Surgical repair of AAA in men depends on the size of the aneurysm and rate of growth.

For men, surgical repair is standard when the AAA reaches 5.5 cm or if the AAA is growing faster than 1.0 cm per year and is larger than 4.0 cm. For women, surgical repair is often recommended between 5.0 cm and 5.4 cm in size.

Surgical repair is not recommended for AAAs that are less than 5.0 cm because the annual risk of rupture is 0%-1% below 5.0 cm. The risk increases to 11% for aneurysms that are 5.0-5.9 cm in size.

There are two methods of surgical repair: endovascular aneurysm repair and open repair. Recommendations for the surveillance of AAA between 3.0 cm and 5.5 cm is regular ultrasound surveillance, with the interval becoming shorter as the aneurysm size becomes larger. Exact intervals differ from one guideline group to another.
 

Screening and treatment in women

While it is true that AAAs in women are more likely to rupture at smaller sizes than AAAs in men, the AAAs that rupture in women are more likely to rupture at an older age than AAAs rupture in men.

The prevalence of AAAs in women is thought to be one-sixth of the prevalence of men. In addition, women had a higher 30-day mortality after surgical repair. They also had higher rates of complications for elective surgical repair of AAAs.

For these reasons, it is unclear that the benefits of AAA screening and treatment in women outweigh the risks, and the USPSTF cannot come to a conclusive recommendation for women who have ever smoked or women who have a family history of AAA.

The USPSTF is able to state definitively that they do not recommend screening in women with no smoking history or family history of AAA.
 

Bottom line

The USPSTF recommends screening men aged 65-75 years who have ever smoked and selectively screening men aged 65-75 years with no smoking history. The USPSTF recommends against screening women aged 65-75 years who have never smoked and have no family history of AAA. There is insufficient evidence to either recommend for or against screening women aged 65-75 years who have smoked or have a family history of AAA.

Reference

Owens DK et al. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-18.

Dr. Sprogell is a second-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

The prevalence of abdominal aortic aneurysms (AAAs) is decreasing, thought to be caused by a decrease in smoking. But the risk of death if one ruptures is as high as 81%. So, screening is still an important part of preventive medicine.

When the abdominal aorta enlarges to greater than 3.0 cm, it is considered an aneurysm. Risk factors that can lead to an enlarged aorta include older age, male sex, smoking, history of AAA in a first-degree relative, hypertension, history of other aneurysms, coronary artery disease, cerebrovascular disease, atherosclerosis, and hypercholesterolemia.

History of AAA in a first-degree relative puts patients at double the risk of developing an abdominal aortic aneurysm. Interestingly, diabetes has been associated with a reduced risk of AAA. People of African American, Asian, and Hispanic descent have a reduced risk of AAA.
 

Screening

Screening is performed using abdominal duplex ultrasound. It has high sensitivity (94%-100%) and specificity (98%-100%), is low cost, and has low risk to the patient. The U.S. Preventive Services Task Force breaks its screening recommendations into four categories:

1. Men aged 65-75 years who have ever smoked (at least 100 cigarettes in their lifetime): One-time screening (grade B, moderate net benefit).

2. Men aged 65-75 years who have never smoked: Selectively offer screening (grade C, small net benefit). “To determine whether this service is appropriate, patients and clinicians should consider the patient’s medical history, family history, other risk factors, and personal values.”

3. Women without a smoking history or family history of AAA: Do not perform screening (grade D, recommendation against the service).

4. Women aged 65-75 years who have a smoking history or family history of AAA: There is insufficient evidence on whether or not to screen for AAA (grade I, insufficient evidence).

To assess screening and treatment of AAAs, the USPSTF looked at four randomized, controlled trials largely focused on men older than 65 years. With the combined data, they found 246 men would need to be screened to prevent 1 AAA rupture, and 305 men would need to be screened to prevent 1 death from AAA.

The USPSTF does note that, while the risk of death is lower for elective AAA repair than ruptured AAA, there is still increased risk with elective surgery. In addition, increased screening and detection increases the rate of elective surgery. Overdiagnosis and overtreatment could represent a harm.
 

Treatment

Surgical repair of AAA in men depends on the size of the aneurysm and rate of growth.

For men, surgical repair is standard when the AAA reaches 5.5 cm or if the AAA is growing faster than 1.0 cm per year and is larger than 4.0 cm. For women, surgical repair is often recommended between 5.0 cm and 5.4 cm in size.

Surgical repair is not recommended for AAAs that are less than 5.0 cm because the annual risk of rupture is 0%-1% below 5.0 cm. The risk increases to 11% for aneurysms that are 5.0-5.9 cm in size.

There are two methods of surgical repair: endovascular aneurysm repair and open repair. Recommendations for the surveillance of AAA between 3.0 cm and 5.5 cm is regular ultrasound surveillance, with the interval becoming shorter as the aneurysm size becomes larger. Exact intervals differ from one guideline group to another.
 

Screening and treatment in women

While it is true that AAAs in women are more likely to rupture at smaller sizes than AAAs in men, the AAAs that rupture in women are more likely to rupture at an older age than AAAs rupture in men.

The prevalence of AAAs in women is thought to be one-sixth of the prevalence of men. In addition, women had a higher 30-day mortality after surgical repair. They also had higher rates of complications for elective surgical repair of AAAs.

For these reasons, it is unclear that the benefits of AAA screening and treatment in women outweigh the risks, and the USPSTF cannot come to a conclusive recommendation for women who have ever smoked or women who have a family history of AAA.

The USPSTF is able to state definitively that they do not recommend screening in women with no smoking history or family history of AAA.
 

Bottom line

The USPSTF recommends screening men aged 65-75 years who have ever smoked and selectively screening men aged 65-75 years with no smoking history. The USPSTF recommends against screening women aged 65-75 years who have never smoked and have no family history of AAA. There is insufficient evidence to either recommend for or against screening women aged 65-75 years who have smoked or have a family history of AAA.

Reference

Owens DK et al. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2019 Dec 10;322(22):2211-18.

Dr. Sprogell is a second-year resident in the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

The National Comprehensive Cancer Network (NCCN) has released its first set of guidelines for managing pediatric aggressive mature B-cell lymphomas.

The guidelines highlight the complexities of treating pediatric Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL), as recommendations include a range of multiagent regimens for different patient groups at various time points.

“The treatment of this disease is relatively complicated,” said Kimberly J. Davies, MD, a pediatric hematologist/oncologist at Dana-Farber Cancer Institute in Boston and chair of the guidelines panel. “The chemotherapy regimens have a lot of drugs, a lot of nuances to how they’re supposed to be given. These guidelines delineate that treatment and help the provider … make sure they are delivering the treatment a patient needs.”

The guidelines recommend different regimens according to a patient’s risk group, but the same treatment approach should be used for patients with BL and those with DLBCL.

“The biggest difference between pediatric and adult patients is that pediatric patients are more uniformly treated, regardless of what type of aggressive B-cell lymphoma they have,” said Matthew Barth, MD, a pediatric hematologist/oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and vice chair of the NCCN guidelines panel.

“Adults with diffuse large B-cell lymphoma and Burkitt lymphoma are generally treated with different chemotherapy regimens, but, in pediatrics, we use the same treatment regimens for both diffuse large B-cell lymphoma and Burkitt lymphoma,” he added.

As an example, the new guidelines recommend that pediatric patients with low-risk BL/DLBCL receive the POG9219 regimen (N Engl J Med. 1997 Oct 30;337[18]:1259-66) or FAB/LMB96 regimen A (Br J Haematol. 2008 Jun;141[6]:840-7) as induction, or they should be enrolled in a clinical trial.

On the other hand, induction for high-risk pediatric BL/DLBCL patients should consist of rituximab and a chemotherapy regimen used in the COG ANHL1131 trial. The recommendation to incorporate rituximab in high-risk pediatric patients is based on results from that trial (J Clin Oncol. 2016 May 20. doi: 10.1200/JCO.2016.34.15_suppl.10507).

“Until recent clinical trial data was available, we weren’t really sure how to incorporate rituximab into the treatment of pediatric patients with mature B-cell lymphomas,” Dr. Barth said. “We now have evidence that rituximab is clearly beneficial for patients who are in higher-risk groups.”

Dr. Barth and Dr. Davies both noted that pediatric BL and DLBCL have high cure rates. Long-term survival rates range from about 80% to more than 90%, according to the American Cancer Society. However, the patients who do relapse or progress can be difficult to treat.

“We have quite good cure rates at this point in time, which is a great success, but that means that a very small population of patients don’t respond to initial therapy, and … it’s hard to know what the best treatment for those patients is,” Dr. Davies said.

She noted that studies are underway to determine if immunotherapies, including chimeric antigen receptor T-cell therapy, might improve outcomes in patients with relapsed or refractory disease.

For now, the NCCN guidelines recommend clinical trial enrollment for relapsed/refractory patients. Alternatively, these patients can receive additional chemotherapy, and responders can proceed to transplant. Patients who don’t achieve at least a partial response may go on to a clinical trial or receive best supportive care.

Dr. Davies and Dr. Barth reported having no conflicts of interest.

[email protected]

The National Comprehensive Cancer Network (NCCN) has released its first set of guidelines for managing pediatric aggressive mature B-cell lymphomas.

The guidelines highlight the complexities of treating pediatric Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL), as recommendations include a range of multiagent regimens for different patient groups at various time points.

“The treatment of this disease is relatively complicated,” said Kimberly J. Davies, MD, a pediatric hematologist/oncologist at Dana-Farber Cancer Institute in Boston and chair of the guidelines panel. “The chemotherapy regimens have a lot of drugs, a lot of nuances to how they’re supposed to be given. These guidelines delineate that treatment and help the provider … make sure they are delivering the treatment a patient needs.”

The guidelines recommend different regimens according to a patient’s risk group, but the same treatment approach should be used for patients with BL and those with DLBCL.

“The biggest difference between pediatric and adult patients is that pediatric patients are more uniformly treated, regardless of what type of aggressive B-cell lymphoma they have,” said Matthew Barth, MD, a pediatric hematologist/oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and vice chair of the NCCN guidelines panel.

“Adults with diffuse large B-cell lymphoma and Burkitt lymphoma are generally treated with different chemotherapy regimens, but, in pediatrics, we use the same treatment regimens for both diffuse large B-cell lymphoma and Burkitt lymphoma,” he added.

As an example, the new guidelines recommend that pediatric patients with low-risk BL/DLBCL receive the POG9219 regimen (N Engl J Med. 1997 Oct 30;337[18]:1259-66) or FAB/LMB96 regimen A (Br J Haematol. 2008 Jun;141[6]:840-7) as induction, or they should be enrolled in a clinical trial.

On the other hand, induction for high-risk pediatric BL/DLBCL patients should consist of rituximab and a chemotherapy regimen used in the COG ANHL1131 trial. The recommendation to incorporate rituximab in high-risk pediatric patients is based on results from that trial (J Clin Oncol. 2016 May 20. doi: 10.1200/JCO.2016.34.15_suppl.10507).

“Until recent clinical trial data was available, we weren’t really sure how to incorporate rituximab into the treatment of pediatric patients with mature B-cell lymphomas,” Dr. Barth said. “We now have evidence that rituximab is clearly beneficial for patients who are in higher-risk groups.”

Dr. Barth and Dr. Davies both noted that pediatric BL and DLBCL have high cure rates. Long-term survival rates range from about 80% to more than 90%, according to the American Cancer Society. However, the patients who do relapse or progress can be difficult to treat.

“We have quite good cure rates at this point in time, which is a great success, but that means that a very small population of patients don’t respond to initial therapy, and … it’s hard to know what the best treatment for those patients is,” Dr. Davies said.

She noted that studies are underway to determine if immunotherapies, including chimeric antigen receptor T-cell therapy, might improve outcomes in patients with relapsed or refractory disease.

For now, the NCCN guidelines recommend clinical trial enrollment for relapsed/refractory patients. Alternatively, these patients can receive additional chemotherapy, and responders can proceed to transplant. Patients who don’t achieve at least a partial response may go on to a clinical trial or receive best supportive care.

Dr. Davies and Dr. Barth reported having no conflicts of interest.

[email protected]

The National Comprehensive Cancer Network (NCCN) has released its first set of guidelines for managing pediatric aggressive mature B-cell lymphomas.

The guidelines highlight the complexities of treating pediatric Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL), as recommendations include a range of multiagent regimens for different patient groups at various time points.

“The treatment of this disease is relatively complicated,” said Kimberly J. Davies, MD, a pediatric hematologist/oncologist at Dana-Farber Cancer Institute in Boston and chair of the guidelines panel. “The chemotherapy regimens have a lot of drugs, a lot of nuances to how they’re supposed to be given. These guidelines delineate that treatment and help the provider … make sure they are delivering the treatment a patient needs.”

The guidelines recommend different regimens according to a patient’s risk group, but the same treatment approach should be used for patients with BL and those with DLBCL.

“The biggest difference between pediatric and adult patients is that pediatric patients are more uniformly treated, regardless of what type of aggressive B-cell lymphoma they have,” said Matthew Barth, MD, a pediatric hematologist/oncologist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and vice chair of the NCCN guidelines panel.

“Adults with diffuse large B-cell lymphoma and Burkitt lymphoma are generally treated with different chemotherapy regimens, but, in pediatrics, we use the same treatment regimens for both diffuse large B-cell lymphoma and Burkitt lymphoma,” he added.

As an example, the new guidelines recommend that pediatric patients with low-risk BL/DLBCL receive the POG9219 regimen (N Engl J Med. 1997 Oct 30;337[18]:1259-66) or FAB/LMB96 regimen A (Br J Haematol. 2008 Jun;141[6]:840-7) as induction, or they should be enrolled in a clinical trial.

On the other hand, induction for high-risk pediatric BL/DLBCL patients should consist of rituximab and a chemotherapy regimen used in the COG ANHL1131 trial. The recommendation to incorporate rituximab in high-risk pediatric patients is based on results from that trial (J Clin Oncol. 2016 May 20. doi: 10.1200/JCO.2016.34.15_suppl.10507).

“Until recent clinical trial data was available, we weren’t really sure how to incorporate rituximab into the treatment of pediatric patients with mature B-cell lymphomas,” Dr. Barth said. “We now have evidence that rituximab is clearly beneficial for patients who are in higher-risk groups.”

Dr. Barth and Dr. Davies both noted that pediatric BL and DLBCL have high cure rates. Long-term survival rates range from about 80% to more than 90%, according to the American Cancer Society. However, the patients who do relapse or progress can be difficult to treat.

“We have quite good cure rates at this point in time, which is a great success, but that means that a very small population of patients don’t respond to initial therapy, and … it’s hard to know what the best treatment for those patients is,” Dr. Davies said.

She noted that studies are underway to determine if immunotherapies, including chimeric antigen receptor T-cell therapy, might improve outcomes in patients with relapsed or refractory disease.

For now, the NCCN guidelines recommend clinical trial enrollment for relapsed/refractory patients. Alternatively, these patients can receive additional chemotherapy, and responders can proceed to transplant. Patients who don’t achieve at least a partial response may go on to a clinical trial or receive best supportive care.

Dr. Davies and Dr. Barth reported having no conflicts of interest.

[email protected]

ATLANTA – One of the goals in soon-to-be-published Takayasu’s arteritis guidelines from the American College of Rheumatology is to wean patients off high-dose steroids once they are in remission.

M. Alexander Otto

This recommendation is in opposition to another option – namely, switching these patients to low-dose glucocorticoids. The idea is to prevent long-term side effects, particularly in children. The guidelines also recommend against escalating immunotherapy for asymptomatic increases in inflammatory markers and generally recommend against surgery – stenting in most cases – unless there is threat to life, limb, or organ and also if limb pain is so severe it cramps quality of life and dose escalation doesn’t get the job done. If surgery is planned, patients should be on perioperative steroids if there’s active disease.

It’s draft guidance for now, but it’s probably what the final document will say when it’s published in 2020, according to a presentation at the annual meeting of the American College of Rheumatology by one of the authors, Anisha Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. She gave a sneak preview at the meeting.

In general, severe, active Takayasu’s calls for high-dose oral steroids in conjunction with a nonsteroid immunosuppressive, such as methotrexate, azathioprine, leflunomide, or mycophenolate mofetil. There’s evidence that dual therapy gives a more durable remission and also reduces the need for steroids.

When that approach doesn’t do the trick, the next step is a tumor necrosis factor (TNF) inhibitor. There’s evidence for infliximab, adalimumab, certolizumab, and etanercept. Dr. Dua noted, “We still can consider” tocilizumab, but it failed to meet its primary endpoint in a randomized trial, and evidence for other biologics is sparse or nonexistent. “TNF inhibitors are the first line” for refractory disease, Dr. Dua said.

The steroid taper comes after 6-12 months of remission. Given their toxicity, “our goal for steroids is zero,” especially in pediatric populations. Even in remission, patients should have a clinical assessment, including inflammatory markers, every 3-12 months.

A rise in C-reactive protein or erythrocyte sedimentation rate, with no new symptoms, might be a reason for more frequent monitoring, but it’s not a reason to escalate immunosuppression. That should be kept in reserve for new vascular lesions, rapid progression on an old one, or worsening of organ or limb ischemia.

“We recommend [escalation] over surgical intervention” because patients often develop collateral circulation that solves the problem; it also gives the disease time to quiet down should the patient eventually go into surgery. Immediate surgery is reserved for organ or life-threatening disease, Dr. Dua said.

“Takayasu’s is different from other vasculitides in the sense that patients often present with certain nonspecific constitutional symptoms,” and there’s not a lot of pathology or histology to work with, “so we do tend to rely on imaging a lot,” Dr. Dua said.

Angiography has fallen out of favor because it’s invasive and exposes patients to radiation, among other problems. The field has moved to noninvasive imaging such as color Doppler ultrasound, CT angiography, magnetic resonance angiography, and PET CT.

“We do recommend regularly scheduled, noninvasive imaging every 6-12 months, in addition to the routine clinical assessment,” except in children with inactive disease; the risk of sedation outweighs the imaging benefit, Dr. Dua said.

In patients with single-vessel cranial or cervical stenosis, without symptoms, “we recommend medical over surgical management because of the risk of surgery. Surgery can be considered for multivessel involvement,” she said.

She and her colleagues also recommend medical management for renal artery stenosis, including antihypertensives and immunotherapy escalation for active disease. Surgery is considered for refractory hypertension or worsening kidney function

Dr. Dua is a primary investigator and adviser for Chemocentryx and an adviser for Novartis and AbbVie.

[email protected]

ATLANTA – One of the goals in soon-to-be-published Takayasu’s arteritis guidelines from the American College of Rheumatology is to wean patients off high-dose steroids once they are in remission.

M. Alexander Otto

This recommendation is in opposition to another option – namely, switching these patients to low-dose glucocorticoids. The idea is to prevent long-term side effects, particularly in children. The guidelines also recommend against escalating immunotherapy for asymptomatic increases in inflammatory markers and generally recommend against surgery – stenting in most cases – unless there is threat to life, limb, or organ and also if limb pain is so severe it cramps quality of life and dose escalation doesn’t get the job done. If surgery is planned, patients should be on perioperative steroids if there’s active disease.

It’s draft guidance for now, but it’s probably what the final document will say when it’s published in 2020, according to a presentation at the annual meeting of the American College of Rheumatology by one of the authors, Anisha Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. She gave a sneak preview at the meeting.

In general, severe, active Takayasu’s calls for high-dose oral steroids in conjunction with a nonsteroid immunosuppressive, such as methotrexate, azathioprine, leflunomide, or mycophenolate mofetil. There’s evidence that dual therapy gives a more durable remission and also reduces the need for steroids.

When that approach doesn’t do the trick, the next step is a tumor necrosis factor (TNF) inhibitor. There’s evidence for infliximab, adalimumab, certolizumab, and etanercept. Dr. Dua noted, “We still can consider” tocilizumab, but it failed to meet its primary endpoint in a randomized trial, and evidence for other biologics is sparse or nonexistent. “TNF inhibitors are the first line” for refractory disease, Dr. Dua said.

The steroid taper comes after 6-12 months of remission. Given their toxicity, “our goal for steroids is zero,” especially in pediatric populations. Even in remission, patients should have a clinical assessment, including inflammatory markers, every 3-12 months.

A rise in C-reactive protein or erythrocyte sedimentation rate, with no new symptoms, might be a reason for more frequent monitoring, but it’s not a reason to escalate immunosuppression. That should be kept in reserve for new vascular lesions, rapid progression on an old one, or worsening of organ or limb ischemia.

“We recommend [escalation] over surgical intervention” because patients often develop collateral circulation that solves the problem; it also gives the disease time to quiet down should the patient eventually go into surgery. Immediate surgery is reserved for organ or life-threatening disease, Dr. Dua said.

“Takayasu’s is different from other vasculitides in the sense that patients often present with certain nonspecific constitutional symptoms,” and there’s not a lot of pathology or histology to work with, “so we do tend to rely on imaging a lot,” Dr. Dua said.

Angiography has fallen out of favor because it’s invasive and exposes patients to radiation, among other problems. The field has moved to noninvasive imaging such as color Doppler ultrasound, CT angiography, magnetic resonance angiography, and PET CT.

“We do recommend regularly scheduled, noninvasive imaging every 6-12 months, in addition to the routine clinical assessment,” except in children with inactive disease; the risk of sedation outweighs the imaging benefit, Dr. Dua said.

In patients with single-vessel cranial or cervical stenosis, without symptoms, “we recommend medical over surgical management because of the risk of surgery. Surgery can be considered for multivessel involvement,” she said.

She and her colleagues also recommend medical management for renal artery stenosis, including antihypertensives and immunotherapy escalation for active disease. Surgery is considered for refractory hypertension or worsening kidney function

Dr. Dua is a primary investigator and adviser for Chemocentryx and an adviser for Novartis and AbbVie.

[email protected]

ATLANTA – One of the goals in soon-to-be-published Takayasu’s arteritis guidelines from the American College of Rheumatology is to wean patients off high-dose steroids once they are in remission.

M. Alexander Otto

This recommendation is in opposition to another option – namely, switching these patients to low-dose glucocorticoids. The idea is to prevent long-term side effects, particularly in children. The guidelines also recommend against escalating immunotherapy for asymptomatic increases in inflammatory markers and generally recommend against surgery – stenting in most cases – unless there is threat to life, limb, or organ and also if limb pain is so severe it cramps quality of life and dose escalation doesn’t get the job done. If surgery is planned, patients should be on perioperative steroids if there’s active disease.

It’s draft guidance for now, but it’s probably what the final document will say when it’s published in 2020, according to a presentation at the annual meeting of the American College of Rheumatology by one of the authors, Anisha Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. She gave a sneak preview at the meeting.

In general, severe, active Takayasu’s calls for high-dose oral steroids in conjunction with a nonsteroid immunosuppressive, such as methotrexate, azathioprine, leflunomide, or mycophenolate mofetil. There’s evidence that dual therapy gives a more durable remission and also reduces the need for steroids.

When that approach doesn’t do the trick, the next step is a tumor necrosis factor (TNF) inhibitor. There’s evidence for infliximab, adalimumab, certolizumab, and etanercept. Dr. Dua noted, “We still can consider” tocilizumab, but it failed to meet its primary endpoint in a randomized trial, and evidence for other biologics is sparse or nonexistent. “TNF inhibitors are the first line” for refractory disease, Dr. Dua said.

The steroid taper comes after 6-12 months of remission. Given their toxicity, “our goal for steroids is zero,” especially in pediatric populations. Even in remission, patients should have a clinical assessment, including inflammatory markers, every 3-12 months.

A rise in C-reactive protein or erythrocyte sedimentation rate, with no new symptoms, might be a reason for more frequent monitoring, but it’s not a reason to escalate immunosuppression. That should be kept in reserve for new vascular lesions, rapid progression on an old one, or worsening of organ or limb ischemia.

“We recommend [escalation] over surgical intervention” because patients often develop collateral circulation that solves the problem; it also gives the disease time to quiet down should the patient eventually go into surgery. Immediate surgery is reserved for organ or life-threatening disease, Dr. Dua said.

“Takayasu’s is different from other vasculitides in the sense that patients often present with certain nonspecific constitutional symptoms,” and there’s not a lot of pathology or histology to work with, “so we do tend to rely on imaging a lot,” Dr. Dua said.

Angiography has fallen out of favor because it’s invasive and exposes patients to radiation, among other problems. The field has moved to noninvasive imaging such as color Doppler ultrasound, CT angiography, magnetic resonance angiography, and PET CT.

“We do recommend regularly scheduled, noninvasive imaging every 6-12 months, in addition to the routine clinical assessment,” except in children with inactive disease; the risk of sedation outweighs the imaging benefit, Dr. Dua said.

In patients with single-vessel cranial or cervical stenosis, without symptoms, “we recommend medical over surgical management because of the risk of surgery. Surgery can be considered for multivessel involvement,” she said.

She and her colleagues also recommend medical management for renal artery stenosis, including antihypertensives and immunotherapy escalation for active disease. Surgery is considered for refractory hypertension or worsening kidney function

Dr. Dua is a primary investigator and adviser for Chemocentryx and an adviser for Novartis and AbbVie.

[email protected]

With much of the public now wearing devices on their wrists or elsewhere capable of recording a range of vital signs, including heart rate abnormalities, the Heart Rhythm Society launched a guide for American consumers about wearables and the data they collect during a session on Jan. 9 at CES 2020 in Las Vegas.

Mitchel L. Zoler/MDedge News

While providing a succinct but comprehensive overview of the types of wearables and the health metrics they can record, the main and recurring message of the 10-page e-pamphlet is that, when a layperson has a question or concern about their data, the best course is to consult a clinician.

The “Guidance for Wearable Health Solutions,” produced by the Heart Rhythm Society (HRS) along with the Consumer Technology Association (CTA, which presents the annual CES exhibition), cautions that “most wearables are primarily suited for fitness and wellness,” and stresses that wearables “are not a substitute for medical devices prescribed by a clinician.” And in all cases, the document advises, when questions arise about the data – including an apparently high heart rate; a reading the device identifies as abnormal; and when symptoms appear such as a rapid heart rate, dizziness, or fluttering or flopping of the heart – the response that the guidance advocates is consistent: Talk with your clinician.

“Heart Rhythm Society members are seeing more and more patients with their own data collected by wearables,” said Nassir F. Marrouche, MD, professor of medicine and director of electrophysiology at Tulane University, New Orleans, and a member of the panel that wrote the guidance document for the HRS and CTA. “Every provider is dealing with consumer wearable data. The need is important for consumers to be supported. Consumers and patients are buying over-the-counter devices and using them for diagnosis and management, with little to no guidance, and we want to help them feel supported in managing their data and understand what to do with it,” Dr. Marrouche said in an interview.

“This is a new reality in medicine; the direction of information is changing. Consumers are collecting data themselves and coming to physicians already informed. There is a new shift in how information is collected, shared, and used.” Dr. Marrouche was 1 of 5 cardiac electrophysiologists who served on the 11-member writing group.

The new document for consumers “addresses an unmet need,” and the HRS collaboration with the CTA was “a unique opportunity to develop useful guidance that supports education and empowers consumers,” said Christina Wurster, chief strategy officer for the HRS in Washington and a member of the writing panel. “The questions outlined in the document are questions our members receive daily. The document is a resource they can direct people to.”

The HRS and CTA will “partner with consumer advocacy groups and professional societies to further disseminate the document,” added Ms. Wurster. “We’ll also have a strong push on social media to reach consumer audiences and drive awareness of this new resource,” she said in an interview. In addition, HRS “has strategic partnerships with other societies and will aim to work with them for dissemination, including societies related to internal medicine, emergency medicine, cardiology, and nursing, as well as also working with patient and consumer advocacy groups to reach the public.” The CTA will also actively publicize and disseminate the guidance document through their members.
 

Clinical guidelines play catch-up

Ironically, the HRS has issued this guidance to the public and has told people to take their wearable-collected heart data to clinicians before the HRS or any other medical group has advised clinicians on how they should handle, interpret, and use heart rhythm data collected this way.

Presumably, many if not most of the people with questions about their heart data from wearables are asymptomatic, because symptoms are what usually drive patients with a cardiac arrhythmia to consult a physician – they don’t wait to see what their device tells them. But the best way to manage asymptomatic arrhythmias like atrial fibrillation (AFib) remains a big clinical uncertainty today, with no evidence base as a guide, although several studies exploring this question are in progress.

Mitchel L. Zoler/MDedge News

“There are no clear and definitive data showing that treating subclinical atrial fibrillation improves outcomes. That’s what we need, and until we get these data you won’t see strong recommendations in guidelines” to screen patients for asymptomatic AFib or other arrhythmias, said Sana M. Al-Khatib, MD, a cardiac electrophysiologist and professor of medicine at Duke University, Durham, N.C., during the 2019 American Heart Association scientific sessions in Philadelphia in a talk about wearables and guidelines.

“If you intervene with silent AFib, do you improve outcomes? That evidence is lacking,” she said. Another shortcoming of current evidence is a clear understanding of what AFib burden warrants intervention, added Dr. Al-Khatib. “We see high-rate AFib episodes recorded in patients with implanted cardiac devices [and no symptoms], and we don’t know what to do with that either.”

The closest any existing guideline from a medical society comes to currently endorsing screening for AFib by a wearable is the 2016 European Society of Cardiology’s AFib management guidelines, which give “opportunistic screening” among people aged older than 65 years a IB recommendation, but specifically for screening by taking a patient’s pulse or with a ECG recording, with no mention of the screening role for wearables (Eur Heart J. 2016 Oct 7;37[38]:2893-967), Dr. Al-Khatib noted.

The most extensive data on screening for asymptomatic AFib in an unselected population came in the recently reported results from the Apple Heart Study, which enrolled more than 419,000 people monitored by a smart watch for a median of 117 days. During this screening, 2,161 people (0.52%) received a notification of having an irregular pulse (including 3.1% of those who were aged at least 65 years), which triggered more intensive assessment with an ECG patch for a median of 13 days in 450 of the 2,161 screening positives (21%) who agreed to participate in this follow-up. Among those 450 people, the patch test identified 34% as having actual AFib (N Engl J Med. 2019 Nov 14;381[20]:1909-17). But while this study provided evidence that screening for an irregular heartbeat with a wearable can identify AFib with some level of success, the results did not address whether this approach improved short- or long-term patient outcomes.

In addition, what the Apple Heart Study results showed was that this sort of screening results in a relatively large volume of follow-up testing. Of the 2,161 participants who received an irregular pulse notification, 1,376 (64%) returned a 90-day survey. Of these, 787 (57%) reported contact with a health care provider outside the study, 28% were prescribed a new medication, 33% were recommended to see a specialist (such as a cardiologist), and 36% were recommended to have additional testing.

Mitchel L. Zoler/MDedge News

“The results raise the question that a lot of resources were used,” to assess patients with a positive screening result, noted Paul A. Heidenreich, MD, a cardiologist and professor of medicine at Stanford (Calif.) University who studies quality of care for patients with heart disease. He estimated that, in the Apple Heart Study, each of the more than 2,000 patients who screening positive for an irregular heartbeat and underwent subsequent assessment ran up about $700 worth of follow-up testing. But he added that, in the case of AFib, the primary intervention that many previously undiagnosed AFib patients receive is some sort of anticoagulation for stroke prevention. Moreover, because this intervention is so effective there is a lot of money to play with to make AFib screening cost effective, as judged by typical, contemporary metrics of cost efficacy that value a quality-adjusted life-year (QALY) gain as reasonable for society to pay if the cost of an incremental QALY is $50,000-$150,000.

If the benchmark is a cost that’s within $50,000/QALY, then an average follow-up cost of $116/person to assess screened positives can fall within this cost ceiling. If the benchmark is $150,000/QALY, then follow-up costs can run as high as $491/person screened, said Dr. Heidenreich during the same AHA session where Dr. Al-Khatib spoke last November.

Despite this good news for screening for AFib with a wearable from a cost-effectiveness perspective, “there is so much uncertainty regarding the benefit and the consequences of incidental findings that we need an outcomes study before widespread implementation” of this type of screening, Dr. Heidenreich concluded. “We need an outcomes study to feel comfortable” with screening. “There is a huge potential for extra care that we don’t understand.”

Dr. Marrouche agreed that collecting adequate evidence to drive changes in clinical guidelines on how to use data from wearables has lagged behind the rapid spread of wearables and the information they can produce among the American public. “Outcomes and evidence will support guidelines development, but in the meantime, we’re offering education to clinicians, patients, and consumers. Consumers own their data, and they can share them with whomever they choose.”

The document notes that people who use wearables are, in general, “enthusiastic about tracking their data, not only for their own use, but also to share” with others, often on social media websites.

“We cannot control that, but our goal in the document is focused on the clinical relevance [of the data] and to help people better understand their data and use it in a meaningful and safe way,” Dr. Marrouche said.

Dr. Marrouche has been a consultant to, advisor to, or received research support from Abbott, Biosense Webster, Biotronik, GE Healthcare, Medtronic, Preventice, Sanofi-Aventis, Siemens, and Vytronus. Ms. Wurster is an employee of the Heart Rhythm Society. Dr. Al-Khatib has been a consultant to Milestone Pharmaceuticals and Medtronic, and she has also received other financial benefits from Medtronic. Dr. Heidenreich had no disclosures,

[email protected]

With much of the public now wearing devices on their wrists or elsewhere capable of recording a range of vital signs, including heart rate abnormalities, the Heart Rhythm Society launched a guide for American consumers about wearables and the data they collect during a session on Jan. 9 at CES 2020 in Las Vegas.

Mitchel L. Zoler/MDedge News

While providing a succinct but comprehensive overview of the types of wearables and the health metrics they can record, the main and recurring message of the 10-page e-pamphlet is that, when a layperson has a question or concern about their data, the best course is to consult a clinician.

The “Guidance for Wearable Health Solutions,” produced by the Heart Rhythm Society (HRS) along with the Consumer Technology Association (CTA, which presents the annual CES exhibition), cautions that “most wearables are primarily suited for fitness and wellness,” and stresses that wearables “are not a substitute for medical devices prescribed by a clinician.” And in all cases, the document advises, when questions arise about the data – including an apparently high heart rate; a reading the device identifies as abnormal; and when symptoms appear such as a rapid heart rate, dizziness, or fluttering or flopping of the heart – the response that the guidance advocates is consistent: Talk with your clinician.

“Heart Rhythm Society members are seeing more and more patients with their own data collected by wearables,” said Nassir F. Marrouche, MD, professor of medicine and director of electrophysiology at Tulane University, New Orleans, and a member of the panel that wrote the guidance document for the HRS and CTA. “Every provider is dealing with consumer wearable data. The need is important for consumers to be supported. Consumers and patients are buying over-the-counter devices and using them for diagnosis and management, with little to no guidance, and we want to help them feel supported in managing their data and understand what to do with it,” Dr. Marrouche said in an interview.

“This is a new reality in medicine; the direction of information is changing. Consumers are collecting data themselves and coming to physicians already informed. There is a new shift in how information is collected, shared, and used.” Dr. Marrouche was 1 of 5 cardiac electrophysiologists who served on the 11-member writing group.

The new document for consumers “addresses an unmet need,” and the HRS collaboration with the CTA was “a unique opportunity to develop useful guidance that supports education and empowers consumers,” said Christina Wurster, chief strategy officer for the HRS in Washington and a member of the writing panel. “The questions outlined in the document are questions our members receive daily. The document is a resource they can direct people to.”

The HRS and CTA will “partner with consumer advocacy groups and professional societies to further disseminate the document,” added Ms. Wurster. “We’ll also have a strong push on social media to reach consumer audiences and drive awareness of this new resource,” she said in an interview. In addition, HRS “has strategic partnerships with other societies and will aim to work with them for dissemination, including societies related to internal medicine, emergency medicine, cardiology, and nursing, as well as also working with patient and consumer advocacy groups to reach the public.” The CTA will also actively publicize and disseminate the guidance document through their members.
 

Clinical guidelines play catch-up

Ironically, the HRS has issued this guidance to the public and has told people to take their wearable-collected heart data to clinicians before the HRS or any other medical group has advised clinicians on how they should handle, interpret, and use heart rhythm data collected this way.

Presumably, many if not most of the people with questions about their heart data from wearables are asymptomatic, because symptoms are what usually drive patients with a cardiac arrhythmia to consult a physician – they don’t wait to see what their device tells them. But the best way to manage asymptomatic arrhythmias like atrial fibrillation (AFib) remains a big clinical uncertainty today, with no evidence base as a guide, although several studies exploring this question are in progress.

Mitchel L. Zoler/MDedge News

“There are no clear and definitive data showing that treating subclinical atrial fibrillation improves outcomes. That’s what we need, and until we get these data you won’t see strong recommendations in guidelines” to screen patients for asymptomatic AFib or other arrhythmias, said Sana M. Al-Khatib, MD, a cardiac electrophysiologist and professor of medicine at Duke University, Durham, N.C., during the 2019 American Heart Association scientific sessions in Philadelphia in a talk about wearables and guidelines.

“If you intervene with silent AFib, do you improve outcomes? That evidence is lacking,” she said. Another shortcoming of current evidence is a clear understanding of what AFib burden warrants intervention, added Dr. Al-Khatib. “We see high-rate AFib episodes recorded in patients with implanted cardiac devices [and no symptoms], and we don’t know what to do with that either.”

The closest any existing guideline from a medical society comes to currently endorsing screening for AFib by a wearable is the 2016 European Society of Cardiology’s AFib management guidelines, which give “opportunistic screening” among people aged older than 65 years a IB recommendation, but specifically for screening by taking a patient’s pulse or with a ECG recording, with no mention of the screening role for wearables (Eur Heart J. 2016 Oct 7;37[38]:2893-967), Dr. Al-Khatib noted.

The most extensive data on screening for asymptomatic AFib in an unselected population came in the recently reported results from the Apple Heart Study, which enrolled more than 419,000 people monitored by a smart watch for a median of 117 days. During this screening, 2,161 people (0.52%) received a notification of having an irregular pulse (including 3.1% of those who were aged at least 65 years), which triggered more intensive assessment with an ECG patch for a median of 13 days in 450 of the 2,161 screening positives (21%) who agreed to participate in this follow-up. Among those 450 people, the patch test identified 34% as having actual AFib (N Engl J Med. 2019 Nov 14;381[20]:1909-17). But while this study provided evidence that screening for an irregular heartbeat with a wearable can identify AFib with some level of success, the results did not address whether this approach improved short- or long-term patient outcomes.

In addition, what the Apple Heart Study results showed was that this sort of screening results in a relatively large volume of follow-up testing. Of the 2,161 participants who received an irregular pulse notification, 1,376 (64%) returned a 90-day survey. Of these, 787 (57%) reported contact with a health care provider outside the study, 28% were prescribed a new medication, 33% were recommended to see a specialist (such as a cardiologist), and 36% were recommended to have additional testing.

Mitchel L. Zoler/MDedge News

“The results raise the question that a lot of resources were used,” to assess patients with a positive screening result, noted Paul A. Heidenreich, MD, a cardiologist and professor of medicine at Stanford (Calif.) University who studies quality of care for patients with heart disease. He estimated that, in the Apple Heart Study, each of the more than 2,000 patients who screening positive for an irregular heartbeat and underwent subsequent assessment ran up about $700 worth of follow-up testing. But he added that, in the case of AFib, the primary intervention that many previously undiagnosed AFib patients receive is some sort of anticoagulation for stroke prevention. Moreover, because this intervention is so effective there is a lot of money to play with to make AFib screening cost effective, as judged by typical, contemporary metrics of cost efficacy that value a quality-adjusted life-year (QALY) gain as reasonable for society to pay if the cost of an incremental QALY is $50,000-$150,000.

If the benchmark is a cost that’s within $50,000/QALY, then an average follow-up cost of $116/person to assess screened positives can fall within this cost ceiling. If the benchmark is $150,000/QALY, then follow-up costs can run as high as $491/person screened, said Dr. Heidenreich during the same AHA session where Dr. Al-Khatib spoke last November.

Despite this good news for screening for AFib with a wearable from a cost-effectiveness perspective, “there is so much uncertainty regarding the benefit and the consequences of incidental findings that we need an outcomes study before widespread implementation” of this type of screening, Dr. Heidenreich concluded. “We need an outcomes study to feel comfortable” with screening. “There is a huge potential for extra care that we don’t understand.”

Dr. Marrouche agreed that collecting adequate evidence to drive changes in clinical guidelines on how to use data from wearables has lagged behind the rapid spread of wearables and the information they can produce among the American public. “Outcomes and evidence will support guidelines development, but in the meantime, we’re offering education to clinicians, patients, and consumers. Consumers own their data, and they can share them with whomever they choose.”

The document notes that people who use wearables are, in general, “enthusiastic about tracking their data, not only for their own use, but also to share” with others, often on social media websites.

“We cannot control that, but our goal in the document is focused on the clinical relevance [of the data] and to help people better understand their data and use it in a meaningful and safe way,” Dr. Marrouche said.

Dr. Marrouche has been a consultant to, advisor to, or received research support from Abbott, Biosense Webster, Biotronik, GE Healthcare, Medtronic, Preventice, Sanofi-Aventis, Siemens, and Vytronus. Ms. Wurster is an employee of the Heart Rhythm Society. Dr. Al-Khatib has been a consultant to Milestone Pharmaceuticals and Medtronic, and she has also received other financial benefits from Medtronic. Dr. Heidenreich had no disclosures,

[email protected]

With much of the public now wearing devices on their wrists or elsewhere capable of recording a range of vital signs, including heart rate abnormalities, the Heart Rhythm Society launched a guide for American consumers about wearables and the data they collect during a session on Jan. 9 at CES 2020 in Las Vegas.

Mitchel L. Zoler/MDedge News

While providing a succinct but comprehensive overview of the types of wearables and the health metrics they can record, the main and recurring message of the 10-page e-pamphlet is that, when a layperson has a question or concern about their data, the best course is to consult a clinician.

The “Guidance for Wearable Health Solutions,” produced by the Heart Rhythm Society (HRS) along with the Consumer Technology Association (CTA, which presents the annual CES exhibition), cautions that “most wearables are primarily suited for fitness and wellness,” and stresses that wearables “are not a substitute for medical devices prescribed by a clinician.” And in all cases, the document advises, when questions arise about the data – including an apparently high heart rate; a reading the device identifies as abnormal; and when symptoms appear such as a rapid heart rate, dizziness, or fluttering or flopping of the heart – the response that the guidance advocates is consistent: Talk with your clinician.

“Heart Rhythm Society members are seeing more and more patients with their own data collected by wearables,” said Nassir F. Marrouche, MD, professor of medicine and director of electrophysiology at Tulane University, New Orleans, and a member of the panel that wrote the guidance document for the HRS and CTA. “Every provider is dealing with consumer wearable data. The need is important for consumers to be supported. Consumers and patients are buying over-the-counter devices and using them for diagnosis and management, with little to no guidance, and we want to help them feel supported in managing their data and understand what to do with it,” Dr. Marrouche said in an interview.

“This is a new reality in medicine; the direction of information is changing. Consumers are collecting data themselves and coming to physicians already informed. There is a new shift in how information is collected, shared, and used.” Dr. Marrouche was 1 of 5 cardiac electrophysiologists who served on the 11-member writing group.

The new document for consumers “addresses an unmet need,” and the HRS collaboration with the CTA was “a unique opportunity to develop useful guidance that supports education and empowers consumers,” said Christina Wurster, chief strategy officer for the HRS in Washington and a member of the writing panel. “The questions outlined in the document are questions our members receive daily. The document is a resource they can direct people to.”

The HRS and CTA will “partner with consumer advocacy groups and professional societies to further disseminate the document,” added Ms. Wurster. “We’ll also have a strong push on social media to reach consumer audiences and drive awareness of this new resource,” she said in an interview. In addition, HRS “has strategic partnerships with other societies and will aim to work with them for dissemination, including societies related to internal medicine, emergency medicine, cardiology, and nursing, as well as also working with patient and consumer advocacy groups to reach the public.” The CTA will also actively publicize and disseminate the guidance document through their members.
 

Clinical guidelines play catch-up

Ironically, the HRS has issued this guidance to the public and has told people to take their wearable-collected heart data to clinicians before the HRS or any other medical group has advised clinicians on how they should handle, interpret, and use heart rhythm data collected this way.

Presumably, many if not most of the people with questions about their heart data from wearables are asymptomatic, because symptoms are what usually drive patients with a cardiac arrhythmia to consult a physician – they don’t wait to see what their device tells them. But the best way to manage asymptomatic arrhythmias like atrial fibrillation (AFib) remains a big clinical uncertainty today, with no evidence base as a guide, although several studies exploring this question are in progress.

Mitchel L. Zoler/MDedge News

“There are no clear and definitive data showing that treating subclinical atrial fibrillation improves outcomes. That’s what we need, and until we get these data you won’t see strong recommendations in guidelines” to screen patients for asymptomatic AFib or other arrhythmias, said Sana M. Al-Khatib, MD, a cardiac electrophysiologist and professor of medicine at Duke University, Durham, N.C., during the 2019 American Heart Association scientific sessions in Philadelphia in a talk about wearables and guidelines.

“If you intervene with silent AFib, do you improve outcomes? That evidence is lacking,” she said. Another shortcoming of current evidence is a clear understanding of what AFib burden warrants intervention, added Dr. Al-Khatib. “We see high-rate AFib episodes recorded in patients with implanted cardiac devices [and no symptoms], and we don’t know what to do with that either.”

The closest any existing guideline from a medical society comes to currently endorsing screening for AFib by a wearable is the 2016 European Society of Cardiology’s AFib management guidelines, which give “opportunistic screening” among people aged older than 65 years a IB recommendation, but specifically for screening by taking a patient’s pulse or with a ECG recording, with no mention of the screening role for wearables (Eur Heart J. 2016 Oct 7;37[38]:2893-967), Dr. Al-Khatib noted.

The most extensive data on screening for asymptomatic AFib in an unselected population came in the recently reported results from the Apple Heart Study, which enrolled more than 419,000 people monitored by a smart watch for a median of 117 days. During this screening, 2,161 people (0.52%) received a notification of having an irregular pulse (including 3.1% of those who were aged at least 65 years), which triggered more intensive assessment with an ECG patch for a median of 13 days in 450 of the 2,161 screening positives (21%) who agreed to participate in this follow-up. Among those 450 people, the patch test identified 34% as having actual AFib (N Engl J Med. 2019 Nov 14;381[20]:1909-17). But while this study provided evidence that screening for an irregular heartbeat with a wearable can identify AFib with some level of success, the results did not address whether this approach improved short- or long-term patient outcomes.

In addition, what the Apple Heart Study results showed was that this sort of screening results in a relatively large volume of follow-up testing. Of the 2,161 participants who received an irregular pulse notification, 1,376 (64%) returned a 90-day survey. Of these, 787 (57%) reported contact with a health care provider outside the study, 28% were prescribed a new medication, 33% were recommended to see a specialist (such as a cardiologist), and 36% were recommended to have additional testing.

Mitchel L. Zoler/MDedge News

“The results raise the question that a lot of resources were used,” to assess patients with a positive screening result, noted Paul A. Heidenreich, MD, a cardiologist and professor of medicine at Stanford (Calif.) University who studies quality of care for patients with heart disease. He estimated that, in the Apple Heart Study, each of the more than 2,000 patients who screening positive for an irregular heartbeat and underwent subsequent assessment ran up about $700 worth of follow-up testing. But he added that, in the case of AFib, the primary intervention that many previously undiagnosed AFib patients receive is some sort of anticoagulation for stroke prevention. Moreover, because this intervention is so effective there is a lot of money to play with to make AFib screening cost effective, as judged by typical, contemporary metrics of cost efficacy that value a quality-adjusted life-year (QALY) gain as reasonable for society to pay if the cost of an incremental QALY is $50,000-$150,000.

If the benchmark is a cost that’s within $50,000/QALY, then an average follow-up cost of $116/person to assess screened positives can fall within this cost ceiling. If the benchmark is $150,000/QALY, then follow-up costs can run as high as $491/person screened, said Dr. Heidenreich during the same AHA session where Dr. Al-Khatib spoke last November.

Despite this good news for screening for AFib with a wearable from a cost-effectiveness perspective, “there is so much uncertainty regarding the benefit and the consequences of incidental findings that we need an outcomes study before widespread implementation” of this type of screening, Dr. Heidenreich concluded. “We need an outcomes study to feel comfortable” with screening. “There is a huge potential for extra care that we don’t understand.”

Dr. Marrouche agreed that collecting adequate evidence to drive changes in clinical guidelines on how to use data from wearables has lagged behind the rapid spread of wearables and the information they can produce among the American public. “Outcomes and evidence will support guidelines development, but in the meantime, we’re offering education to clinicians, patients, and consumers. Consumers own their data, and they can share them with whomever they choose.”

The document notes that people who use wearables are, in general, “enthusiastic about tracking their data, not only for their own use, but also to share” with others, often on social media websites.

“We cannot control that, but our goal in the document is focused on the clinical relevance [of the data] and to help people better understand their data and use it in a meaningful and safe way,” Dr. Marrouche said.

Dr. Marrouche has been a consultant to, advisor to, or received research support from Abbott, Biosense Webster, Biotronik, GE Healthcare, Medtronic, Preventice, Sanofi-Aventis, Siemens, and Vytronus. Ms. Wurster is an employee of the Heart Rhythm Society. Dr. Al-Khatib has been a consultant to Milestone Pharmaceuticals and Medtronic, and she has also received other financial benefits from Medtronic. Dr. Heidenreich had no disclosures,

[email protected]