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COMMENT & CONTROVERSY
Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes?
JAIMEY M. PAULI, MD (JUNE 2022)
Consider this, when it comes to treating chronic hypertension
I welcome the article by Dr. Jaimey Pauli, which focuses on initiating treatment for mild chronic hypertension in pregnancy to reach a goal blood pressure (BP) of <140/90 mm Hg to prevent adverse maternal and fetal outcomes.1 I would like to offer 3 additional thoughts for your consideration. First, it is known that there is a physiological decrease in BP during the second trimester, which results in a normotensive presentation. Thus, it would be beneficial to see if pregnant women with high-normal BP levels before the third trimester be administered a lower dose of antihypertensives. However, there is also a concern that decreased maternal BP may compromise uteroplacental perfusion and fetal circulation, which also could be evaluated.2
Second, I would like to see how comorbidities affect the initiation of antihypertensives for mild chronic hypertension in pregnancy. Research incorporating pregnant women with borderline hypertension and comorbidities such as obesity, hyperlipidemia, and diabetes mellitus type 2 (DM) is likely to yield informative results. This is especially beneficial since, for example, chronic hypertension and DM are independent risk factors for adverse maternal and fetal outcomes; therefore, a mother with both these conditions may have additive effects on obstetric outcomes.3
Lastly, I would suggest you include a brief conversation about prepregnancy ways to manage women with chronic hypertension. Because many women who enter pregnancy with chronic hypertension have hypertension of unknown origin, it would be beneficial to optimize antihypertensive regimens before conception.4 Also, it should be further evaluated whether initiation of lifestyle modifications, such as weight reduction and the DASH diet before pregnancy, for women with chronic hypertension improves pregnancy outcomes.
Cassandra Maafoh, MD
Macon, Georgia
References
- Pauli JM. Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes? OBG Manag. 2022;34:14-15.
- Brown CM, Garovic VD. Drug treatment of hypertension in pregnancy. Drugs. 2014;74:283-296. https://doi.org/10.1007/s40265-014-0187-7.
- Yanit KE, Snowden JM, Cheng YW, et al. The impact of chronic hypertension and pregestational diabetes on pregnancy outcomes. Am J Obstet Gynecol. 2012;207. https://doi. org/10.1016/j.ajog.2012.06.066.
- Seely EW, Ecker J. Chronic hypertension in pregnancy. Circulation. 2014;129:1254-1261. https:// doi.org/10.1161/circulationaha.113.003904.
BARBARA LEVY, MD (AUGUST 2022)
Are these new and rare syndromes’ pathophysiological mechanisms related?
I read with great interest Dr. Barbara Levy’s UPDATE in the August 2022 issue on testosterone therapy for women with hypoactive sexual desire disorder (HSDD), as well as her comments on persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) that was recently so coined by the International Society for the Study of Women’s Sexual Health (ISSWSH) as a 2-component syndrome.1 The new syndrome, explains Dr. Levy, presents with “the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient (the PGAD component),” combined with “itching, burning, tingling, or pain” (the GPD component).
Although agreeing with ISSWSH that diagnosis and management require a multidisciplinary biopsychosocial approach, in her practical advice, Dr. Levy mentioned: “neuropathic signaling” with “aberrant sensory processing” as the syndrome’s possible main pathophysiology. Interestingly, there are 2 other rare, chronic, and “poorly recognized source(s) of major distress to a small but significant group of patients.” Persistent idiopathic oro-facial pain (PIFP) disorder2 after dental interventions and burning mouth syndrome (BMS),3 defined by the absence of any local or systemic contributing etiology, also present with continuous local burning and pain (as in GPD). Consequently, PGAD/GPD may indeed have the same pathophysiological explanation—as Dr. Levy suggested—of being a (genital) peripheral chronic neuropathic pain condition.
A potentially promising new therapeutic approach for PGAD/GPD would then be to use the same, or similar, antineuropathic medications (Clonazepam, Nortriptyline, Pregabalin, etc.) in the form of topical vaginal swishing solutions similar to the presently recommended antiepileptic and/or antidepressant oral swishing treatment for PIFP and BMS. As the topical approach works well for oral neuropathic pain, vaginal swishing could potentially be the answer for PGAD/GPD peripheral neuropathic pain. Moreover, such a novel topical approach would significantly increase patient motivation for treatment by avoiding the adverse effects of ingested antiepileptic or antidepressant drugs.
This is the first time that anticonvulsant and/or antidepressant vaginal swishing is proposed as topical therapy for GPD peripheral neuropathic pain, still pending scientific/clinical validation. ●
Zwi Hoch, MD
Newton, Massachusetts
- Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.
- Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: facts and fiction. Cephalgia. 2017;37:670-679.
- Kuten-Shorer M, Treister NS, Stock S, et al. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124: 146-151.
Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes?
JAIMEY M. PAULI, MD (JUNE 2022)
Consider this, when it comes to treating chronic hypertension
I welcome the article by Dr. Jaimey Pauli, which focuses on initiating treatment for mild chronic hypertension in pregnancy to reach a goal blood pressure (BP) of <140/90 mm Hg to prevent adverse maternal and fetal outcomes.1 I would like to offer 3 additional thoughts for your consideration. First, it is known that there is a physiological decrease in BP during the second trimester, which results in a normotensive presentation. Thus, it would be beneficial to see if pregnant women with high-normal BP levels before the third trimester be administered a lower dose of antihypertensives. However, there is also a concern that decreased maternal BP may compromise uteroplacental perfusion and fetal circulation, which also could be evaluated.2
Second, I would like to see how comorbidities affect the initiation of antihypertensives for mild chronic hypertension in pregnancy. Research incorporating pregnant women with borderline hypertension and comorbidities such as obesity, hyperlipidemia, and diabetes mellitus type 2 (DM) is likely to yield informative results. This is especially beneficial since, for example, chronic hypertension and DM are independent risk factors for adverse maternal and fetal outcomes; therefore, a mother with both these conditions may have additive effects on obstetric outcomes.3
Lastly, I would suggest you include a brief conversation about prepregnancy ways to manage women with chronic hypertension. Because many women who enter pregnancy with chronic hypertension have hypertension of unknown origin, it would be beneficial to optimize antihypertensive regimens before conception.4 Also, it should be further evaluated whether initiation of lifestyle modifications, such as weight reduction and the DASH diet before pregnancy, for women with chronic hypertension improves pregnancy outcomes.
Cassandra Maafoh, MD
Macon, Georgia
References
- Pauli JM. Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes? OBG Manag. 2022;34:14-15.
- Brown CM, Garovic VD. Drug treatment of hypertension in pregnancy. Drugs. 2014;74:283-296. https://doi.org/10.1007/s40265-014-0187-7.
- Yanit KE, Snowden JM, Cheng YW, et al. The impact of chronic hypertension and pregestational diabetes on pregnancy outcomes. Am J Obstet Gynecol. 2012;207. https://doi. org/10.1016/j.ajog.2012.06.066.
- Seely EW, Ecker J. Chronic hypertension in pregnancy. Circulation. 2014;129:1254-1261. https:// doi.org/10.1161/circulationaha.113.003904.
BARBARA LEVY, MD (AUGUST 2022)
Are these new and rare syndromes’ pathophysiological mechanisms related?
I read with great interest Dr. Barbara Levy’s UPDATE in the August 2022 issue on testosterone therapy for women with hypoactive sexual desire disorder (HSDD), as well as her comments on persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) that was recently so coined by the International Society for the Study of Women’s Sexual Health (ISSWSH) as a 2-component syndrome.1 The new syndrome, explains Dr. Levy, presents with “the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient (the PGAD component),” combined with “itching, burning, tingling, or pain” (the GPD component).
Although agreeing with ISSWSH that diagnosis and management require a multidisciplinary biopsychosocial approach, in her practical advice, Dr. Levy mentioned: “neuropathic signaling” with “aberrant sensory processing” as the syndrome’s possible main pathophysiology. Interestingly, there are 2 other rare, chronic, and “poorly recognized source(s) of major distress to a small but significant group of patients.” Persistent idiopathic oro-facial pain (PIFP) disorder2 after dental interventions and burning mouth syndrome (BMS),3 defined by the absence of any local or systemic contributing etiology, also present with continuous local burning and pain (as in GPD). Consequently, PGAD/GPD may indeed have the same pathophysiological explanation—as Dr. Levy suggested—of being a (genital) peripheral chronic neuropathic pain condition.
A potentially promising new therapeutic approach for PGAD/GPD would then be to use the same, or similar, antineuropathic medications (Clonazepam, Nortriptyline, Pregabalin, etc.) in the form of topical vaginal swishing solutions similar to the presently recommended antiepileptic and/or antidepressant oral swishing treatment for PIFP and BMS. As the topical approach works well for oral neuropathic pain, vaginal swishing could potentially be the answer for PGAD/GPD peripheral neuropathic pain. Moreover, such a novel topical approach would significantly increase patient motivation for treatment by avoiding the adverse effects of ingested antiepileptic or antidepressant drugs.
This is the first time that anticonvulsant and/or antidepressant vaginal swishing is proposed as topical therapy for GPD peripheral neuropathic pain, still pending scientific/clinical validation. ●
Zwi Hoch, MD
Newton, Massachusetts
- Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.
- Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: facts and fiction. Cephalgia. 2017;37:670-679.
- Kuten-Shorer M, Treister NS, Stock S, et al. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124: 146-151.
Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes?
JAIMEY M. PAULI, MD (JUNE 2022)
Consider this, when it comes to treating chronic hypertension
I welcome the article by Dr. Jaimey Pauli, which focuses on initiating treatment for mild chronic hypertension in pregnancy to reach a goal blood pressure (BP) of <140/90 mm Hg to prevent adverse maternal and fetal outcomes.1 I would like to offer 3 additional thoughts for your consideration. First, it is known that there is a physiological decrease in BP during the second trimester, which results in a normotensive presentation. Thus, it would be beneficial to see if pregnant women with high-normal BP levels before the third trimester be administered a lower dose of antihypertensives. However, there is also a concern that decreased maternal BP may compromise uteroplacental perfusion and fetal circulation, which also could be evaluated.2
Second, I would like to see how comorbidities affect the initiation of antihypertensives for mild chronic hypertension in pregnancy. Research incorporating pregnant women with borderline hypertension and comorbidities such as obesity, hyperlipidemia, and diabetes mellitus type 2 (DM) is likely to yield informative results. This is especially beneficial since, for example, chronic hypertension and DM are independent risk factors for adverse maternal and fetal outcomes; therefore, a mother with both these conditions may have additive effects on obstetric outcomes.3
Lastly, I would suggest you include a brief conversation about prepregnancy ways to manage women with chronic hypertension. Because many women who enter pregnancy with chronic hypertension have hypertension of unknown origin, it would be beneficial to optimize antihypertensive regimens before conception.4 Also, it should be further evaluated whether initiation of lifestyle modifications, such as weight reduction and the DASH diet before pregnancy, for women with chronic hypertension improves pregnancy outcomes.
Cassandra Maafoh, MD
Macon, Georgia
References
- Pauli JM. Should treatment be initiated for mild chronic hypertension in pregnancy to improve outcomes? OBG Manag. 2022;34:14-15.
- Brown CM, Garovic VD. Drug treatment of hypertension in pregnancy. Drugs. 2014;74:283-296. https://doi.org/10.1007/s40265-014-0187-7.
- Yanit KE, Snowden JM, Cheng YW, et al. The impact of chronic hypertension and pregestational diabetes on pregnancy outcomes. Am J Obstet Gynecol. 2012;207. https://doi. org/10.1016/j.ajog.2012.06.066.
- Seely EW, Ecker J. Chronic hypertension in pregnancy. Circulation. 2014;129:1254-1261. https:// doi.org/10.1161/circulationaha.113.003904.
BARBARA LEVY, MD (AUGUST 2022)
Are these new and rare syndromes’ pathophysiological mechanisms related?
I read with great interest Dr. Barbara Levy’s UPDATE in the August 2022 issue on testosterone therapy for women with hypoactive sexual desire disorder (HSDD), as well as her comments on persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) that was recently so coined by the International Society for the Study of Women’s Sexual Health (ISSWSH) as a 2-component syndrome.1 The new syndrome, explains Dr. Levy, presents with “the perception of genital arousal that is involuntary, unrelated to sexual desire, without any identified cause, not relieved with orgasm, and distressing to the patient (the PGAD component),” combined with “itching, burning, tingling, or pain” (the GPD component).
Although agreeing with ISSWSH that diagnosis and management require a multidisciplinary biopsychosocial approach, in her practical advice, Dr. Levy mentioned: “neuropathic signaling” with “aberrant sensory processing” as the syndrome’s possible main pathophysiology. Interestingly, there are 2 other rare, chronic, and “poorly recognized source(s) of major distress to a small but significant group of patients.” Persistent idiopathic oro-facial pain (PIFP) disorder2 after dental interventions and burning mouth syndrome (BMS),3 defined by the absence of any local or systemic contributing etiology, also present with continuous local burning and pain (as in GPD). Consequently, PGAD/GPD may indeed have the same pathophysiological explanation—as Dr. Levy suggested—of being a (genital) peripheral chronic neuropathic pain condition.
A potentially promising new therapeutic approach for PGAD/GPD would then be to use the same, or similar, antineuropathic medications (Clonazepam, Nortriptyline, Pregabalin, etc.) in the form of topical vaginal swishing solutions similar to the presently recommended antiepileptic and/or antidepressant oral swishing treatment for PIFP and BMS. As the topical approach works well for oral neuropathic pain, vaginal swishing could potentially be the answer for PGAD/GPD peripheral neuropathic pain. Moreover, such a novel topical approach would significantly increase patient motivation for treatment by avoiding the adverse effects of ingested antiepileptic or antidepressant drugs.
This is the first time that anticonvulsant and/or antidepressant vaginal swishing is proposed as topical therapy for GPD peripheral neuropathic pain, still pending scientific/clinical validation. ●
Zwi Hoch, MD
Newton, Massachusetts
- Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women’s Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med. 2021;18:665-697.
- Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: facts and fiction. Cephalgia. 2017;37:670-679.
- Kuten-Shorer M, Treister NS, Stock S, et al. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124: 146-151.
New developments and barriers to palliative care
As we enter into this new year, it is a good time to review the past few years of living through a pandemic and the impact this has had on the field of palliative care.
According to the World Health Organization, “Palliative care is an approach that improves the quality of life of patients and their families who are facing the problems associated with life-threatening illness, by the prevention and relief of suffering through early identification, assessment and treatment of pain and other problems whether physical, psychosocial and spiritual.”1 They identify a global need and recognize palliative care as a “human right to health and as a standard of care particularly for individuals living with a serious illness.1 However, the WHO goes further to recognize palliative care as an essential part of the response team during crises and health emergencies like a pandemic, noting that a response team without palliative care is “medically deficient and ethically indefensible.”2
The need for palliative care in the United States is projected to grow significantly in the next decades.3 However, there has been insufficient staffing to meet these needs, even prior to the pandemic.4 The demand for palliative care reached further unprecedented levels during the pandemic as palliative care teams played an integral role and were well situated to support not only patients and families with COVID-19,5 but to also support the well-being of health care teams caring for COVID-19 patients.6,7
A recent survey that was conducted by the Center to Advance Palliative Care among palliative care leadership captured the experiences of leading their teams through a pandemic. Below are the results of this survey, which highlighted important issues and developments to palliative care during the pandemic.6
Increasing need for palliative care
One of the main findings from the national survey of palliative care leaders corroborated that the demands for palliative care have increased significantly from 2020 through the pandemic.
As with many areas in the health care system, the pandemic has emphasized the strain and short staffing of the palliative care teams. In the survey, 61% of leaders reported that palliative care consults significantly increased from prepandemic levels. But only 26% of these leaders said they had the staffing support to meet these needs.
Value of palliative care
The value of palliative care along with understanding of the role of palliative care has been better recognized during the pandemic and has been evidenced by the increase in palliative care referrals from clinical providers, compared with prepandemic levels. In addition, data collected showed that earlier palliative care consultations reduced length of hospital stay, decreased ICU admissions, and improved patient, family, and provider satisfaction.
Well-being of the workforce
The pandemic has been a tremendously stressful time for the health care workforce that has undoubtedly led to burnout. A nationwide study of physicians,8 found that 61% of physicians experienced burnout. This is a significant increase from prepandemic levels with impacts on mental health (that is, anxiety, depression). This study did not include palliative care specialists, but the CAPC survey indicates a similar feeling of burnout. Because of this, some palliative care specialists have left the field altogether, or are leaving leadership positions because of burnout and exhaustion from the pandemic. This was featured as a concern among palliative care leaders, where 93% reported concern for the emotional well-being of the palliative care team.
Telehealth
A permanent operational change that has been well-utilized and implemented across multiple health care settings has been providing palliative care through telehealth. Prior to the pandemic, the baseline use of telehealth was less than 5% with the use now greater than 75% – a modality that is favored by both patients and clinicians. This has offered a broader scope of practice, reaching individuals who may have no other means, have limitations to accessing palliative care, or were in circumstances where patients required isolation during the pandemic. However, there are limitations to this platform, including in equity of access to devices and ease of use for those with limited exposure to technology.9
Barriers to implementation
Although the important role and value of palliative care has been well recognized, there have been barriers identified in a qualitative study of the integration of palliative care into COVID-19 action plans that are mentioned below.5
- Patients and families were identified as barriers to integration of palliative care if they were not open to palliative care referral, mainly because of misperceptions of palliative care as end-of-life care.
- Palliative care knowledge among providers was identified as another barrier to integration of palliative care. There are still misperceptions among providers that palliative care is end-of-life care and palliative care involvement is stigmatized as hastening death. In addition, some felt that COVID-19 was not a traditional “palliative diagnosis” thus were less likely to integrate palliative care into care plans.
- Lack of availability of a primary provider to conduct primary palliative care and lack of motivation “not to give up” were identified as other barriers. On the other hand, palliative care provider availability and accessibility to care teams affected the integration into COVID-19 care plans.
- COVID-19 itself was identified to be a barrier because of the uncertainty of illness trajectory and outcomes, which made it difficult for doctors to ascertain when to involve palliative care.
- Leadership and institution were important factors to consider in integration of palliative care into long-term care plans, which depended on leadership engagement and institutional culture.
Takeaways
The past few years have taught us a lot, but there is still much to learn. The COVID-19 pandemic has called attention to the challenges and barriers of health care delivery and has magnified the needs of the health care system including its infrastructure, preparedness, and staffing, including the field of palliative care. More work needs to be done, but leaders have taken steps to initiate national and international preparedness plans including the integration of palliative care, which has been identified as a vital role in any humanitarian crises.10,11
Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle, in the division of geriatrics and gerontology. She has no conflicts related to the content of this article.
References
1. Palliative care. World Health Organization. Aug 5, 2020. https://www.who.int/news-room/fact-sheets/detail/palliative-care
2. World Health Organization. Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: A WHO guide. Geneva: World Health Organization, 2018. https://apps.who.int/iris/handle/10665/274565.
3. Hughes MT, Smith TJ. The growth of palliative care in the United States. Annual Review Public Health. 2014;35:459-75.
4. Pastrana T et al. The impact of COVID-19 on palliative care workers across the world: A qualitative analysis of responses to open-ended questions. Palliative and Supportive Care. 2021:1-6.
5. Wentlandt K et al. Identifying barriers and facilitators to palliative care integration in the management of hospitalized patients with COVID-19: A qualitative study. Palliat Med. 2022;36(6):945-54.
6. Rogers M et al. Palliative care leadership during the pandemic: Results from a recent survey. Center to Advance Palliative Care. 2022 Sept 8. https://www.capc.org/blog/palliative-care-leadership-during-the-pandemic-results-from-a-recent-survey
7. Fogelman P. Reflections form a palliative care program leader two years into the pandemic. Center to Advance Palliative Care. 2023 Jan 15. https://www.capc.org/blog/reflections-from-a-palliative-care-program-leader-two-years-into-the-pandemic
8. 2021 survey of America’s physicians Covid-19 impact edition: A year later. The Physicians Foundation. 2021.
9. Caraceni A et al. Telemedicine for outpatient palliative care during Covid-19 pandemics: A longitudinal study. BMJ Supportive & Palliative Care. 2022;0:1-7.
10. Bausewein C et al. National strategy for palliative care of severely ill and dying people and their relatives in pandemics (PallPan) in Germany – study protocol of a mixed-methods project. BMC Palliative Care. 2022;21(10).
11. Powell RA et al. Palliative care in humanitarian crises: Always something to offer. The Lancet. 2017;389(10078):1498-9.
As we enter into this new year, it is a good time to review the past few years of living through a pandemic and the impact this has had on the field of palliative care.
According to the World Health Organization, “Palliative care is an approach that improves the quality of life of patients and their families who are facing the problems associated with life-threatening illness, by the prevention and relief of suffering through early identification, assessment and treatment of pain and other problems whether physical, psychosocial and spiritual.”1 They identify a global need and recognize palliative care as a “human right to health and as a standard of care particularly for individuals living with a serious illness.1 However, the WHO goes further to recognize palliative care as an essential part of the response team during crises and health emergencies like a pandemic, noting that a response team without palliative care is “medically deficient and ethically indefensible.”2
The need for palliative care in the United States is projected to grow significantly in the next decades.3 However, there has been insufficient staffing to meet these needs, even prior to the pandemic.4 The demand for palliative care reached further unprecedented levels during the pandemic as palliative care teams played an integral role and were well situated to support not only patients and families with COVID-19,5 but to also support the well-being of health care teams caring for COVID-19 patients.6,7
A recent survey that was conducted by the Center to Advance Palliative Care among palliative care leadership captured the experiences of leading their teams through a pandemic. Below are the results of this survey, which highlighted important issues and developments to palliative care during the pandemic.6
Increasing need for palliative care
One of the main findings from the national survey of palliative care leaders corroborated that the demands for palliative care have increased significantly from 2020 through the pandemic.
As with many areas in the health care system, the pandemic has emphasized the strain and short staffing of the palliative care teams. In the survey, 61% of leaders reported that palliative care consults significantly increased from prepandemic levels. But only 26% of these leaders said they had the staffing support to meet these needs.
Value of palliative care
The value of palliative care along with understanding of the role of palliative care has been better recognized during the pandemic and has been evidenced by the increase in palliative care referrals from clinical providers, compared with prepandemic levels. In addition, data collected showed that earlier palliative care consultations reduced length of hospital stay, decreased ICU admissions, and improved patient, family, and provider satisfaction.
Well-being of the workforce
The pandemic has been a tremendously stressful time for the health care workforce that has undoubtedly led to burnout. A nationwide study of physicians,8 found that 61% of physicians experienced burnout. This is a significant increase from prepandemic levels with impacts on mental health (that is, anxiety, depression). This study did not include palliative care specialists, but the CAPC survey indicates a similar feeling of burnout. Because of this, some palliative care specialists have left the field altogether, or are leaving leadership positions because of burnout and exhaustion from the pandemic. This was featured as a concern among palliative care leaders, where 93% reported concern for the emotional well-being of the palliative care team.
Telehealth
A permanent operational change that has been well-utilized and implemented across multiple health care settings has been providing palliative care through telehealth. Prior to the pandemic, the baseline use of telehealth was less than 5% with the use now greater than 75% – a modality that is favored by both patients and clinicians. This has offered a broader scope of practice, reaching individuals who may have no other means, have limitations to accessing palliative care, or were in circumstances where patients required isolation during the pandemic. However, there are limitations to this platform, including in equity of access to devices and ease of use for those with limited exposure to technology.9
Barriers to implementation
Although the important role and value of palliative care has been well recognized, there have been barriers identified in a qualitative study of the integration of palliative care into COVID-19 action plans that are mentioned below.5
- Patients and families were identified as barriers to integration of palliative care if they were not open to palliative care referral, mainly because of misperceptions of palliative care as end-of-life care.
- Palliative care knowledge among providers was identified as another barrier to integration of palliative care. There are still misperceptions among providers that palliative care is end-of-life care and palliative care involvement is stigmatized as hastening death. In addition, some felt that COVID-19 was not a traditional “palliative diagnosis” thus were less likely to integrate palliative care into care plans.
- Lack of availability of a primary provider to conduct primary palliative care and lack of motivation “not to give up” were identified as other barriers. On the other hand, palliative care provider availability and accessibility to care teams affected the integration into COVID-19 care plans.
- COVID-19 itself was identified to be a barrier because of the uncertainty of illness trajectory and outcomes, which made it difficult for doctors to ascertain when to involve palliative care.
- Leadership and institution were important factors to consider in integration of palliative care into long-term care plans, which depended on leadership engagement and institutional culture.
Takeaways
The past few years have taught us a lot, but there is still much to learn. The COVID-19 pandemic has called attention to the challenges and barriers of health care delivery and has magnified the needs of the health care system including its infrastructure, preparedness, and staffing, including the field of palliative care. More work needs to be done, but leaders have taken steps to initiate national and international preparedness plans including the integration of palliative care, which has been identified as a vital role in any humanitarian crises.10,11
Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle, in the division of geriatrics and gerontology. She has no conflicts related to the content of this article.
References
1. Palliative care. World Health Organization. Aug 5, 2020. https://www.who.int/news-room/fact-sheets/detail/palliative-care
2. World Health Organization. Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: A WHO guide. Geneva: World Health Organization, 2018. https://apps.who.int/iris/handle/10665/274565.
3. Hughes MT, Smith TJ. The growth of palliative care in the United States. Annual Review Public Health. 2014;35:459-75.
4. Pastrana T et al. The impact of COVID-19 on palliative care workers across the world: A qualitative analysis of responses to open-ended questions. Palliative and Supportive Care. 2021:1-6.
5. Wentlandt K et al. Identifying barriers and facilitators to palliative care integration in the management of hospitalized patients with COVID-19: A qualitative study. Palliat Med. 2022;36(6):945-54.
6. Rogers M et al. Palliative care leadership during the pandemic: Results from a recent survey. Center to Advance Palliative Care. 2022 Sept 8. https://www.capc.org/blog/palliative-care-leadership-during-the-pandemic-results-from-a-recent-survey
7. Fogelman P. Reflections form a palliative care program leader two years into the pandemic. Center to Advance Palliative Care. 2023 Jan 15. https://www.capc.org/blog/reflections-from-a-palliative-care-program-leader-two-years-into-the-pandemic
8. 2021 survey of America’s physicians Covid-19 impact edition: A year later. The Physicians Foundation. 2021.
9. Caraceni A et al. Telemedicine for outpatient palliative care during Covid-19 pandemics: A longitudinal study. BMJ Supportive & Palliative Care. 2022;0:1-7.
10. Bausewein C et al. National strategy for palliative care of severely ill and dying people and their relatives in pandemics (PallPan) in Germany – study protocol of a mixed-methods project. BMC Palliative Care. 2022;21(10).
11. Powell RA et al. Palliative care in humanitarian crises: Always something to offer. The Lancet. 2017;389(10078):1498-9.
As we enter into this new year, it is a good time to review the past few years of living through a pandemic and the impact this has had on the field of palliative care.
According to the World Health Organization, “Palliative care is an approach that improves the quality of life of patients and their families who are facing the problems associated with life-threatening illness, by the prevention and relief of suffering through early identification, assessment and treatment of pain and other problems whether physical, psychosocial and spiritual.”1 They identify a global need and recognize palliative care as a “human right to health and as a standard of care particularly for individuals living with a serious illness.1 However, the WHO goes further to recognize palliative care as an essential part of the response team during crises and health emergencies like a pandemic, noting that a response team without palliative care is “medically deficient and ethically indefensible.”2
The need for palliative care in the United States is projected to grow significantly in the next decades.3 However, there has been insufficient staffing to meet these needs, even prior to the pandemic.4 The demand for palliative care reached further unprecedented levels during the pandemic as palliative care teams played an integral role and were well situated to support not only patients and families with COVID-19,5 but to also support the well-being of health care teams caring for COVID-19 patients.6,7
A recent survey that was conducted by the Center to Advance Palliative Care among palliative care leadership captured the experiences of leading their teams through a pandemic. Below are the results of this survey, which highlighted important issues and developments to palliative care during the pandemic.6
Increasing need for palliative care
One of the main findings from the national survey of palliative care leaders corroborated that the demands for palliative care have increased significantly from 2020 through the pandemic.
As with many areas in the health care system, the pandemic has emphasized the strain and short staffing of the palliative care teams. In the survey, 61% of leaders reported that palliative care consults significantly increased from prepandemic levels. But only 26% of these leaders said they had the staffing support to meet these needs.
Value of palliative care
The value of palliative care along with understanding of the role of palliative care has been better recognized during the pandemic and has been evidenced by the increase in palliative care referrals from clinical providers, compared with prepandemic levels. In addition, data collected showed that earlier palliative care consultations reduced length of hospital stay, decreased ICU admissions, and improved patient, family, and provider satisfaction.
Well-being of the workforce
The pandemic has been a tremendously stressful time for the health care workforce that has undoubtedly led to burnout. A nationwide study of physicians,8 found that 61% of physicians experienced burnout. This is a significant increase from prepandemic levels with impacts on mental health (that is, anxiety, depression). This study did not include palliative care specialists, but the CAPC survey indicates a similar feeling of burnout. Because of this, some palliative care specialists have left the field altogether, or are leaving leadership positions because of burnout and exhaustion from the pandemic. This was featured as a concern among palliative care leaders, where 93% reported concern for the emotional well-being of the palliative care team.
Telehealth
A permanent operational change that has been well-utilized and implemented across multiple health care settings has been providing palliative care through telehealth. Prior to the pandemic, the baseline use of telehealth was less than 5% with the use now greater than 75% – a modality that is favored by both patients and clinicians. This has offered a broader scope of practice, reaching individuals who may have no other means, have limitations to accessing palliative care, or were in circumstances where patients required isolation during the pandemic. However, there are limitations to this platform, including in equity of access to devices and ease of use for those with limited exposure to technology.9
Barriers to implementation
Although the important role and value of palliative care has been well recognized, there have been barriers identified in a qualitative study of the integration of palliative care into COVID-19 action plans that are mentioned below.5
- Patients and families were identified as barriers to integration of palliative care if they were not open to palliative care referral, mainly because of misperceptions of palliative care as end-of-life care.
- Palliative care knowledge among providers was identified as another barrier to integration of palliative care. There are still misperceptions among providers that palliative care is end-of-life care and palliative care involvement is stigmatized as hastening death. In addition, some felt that COVID-19 was not a traditional “palliative diagnosis” thus were less likely to integrate palliative care into care plans.
- Lack of availability of a primary provider to conduct primary palliative care and lack of motivation “not to give up” were identified as other barriers. On the other hand, palliative care provider availability and accessibility to care teams affected the integration into COVID-19 care plans.
- COVID-19 itself was identified to be a barrier because of the uncertainty of illness trajectory and outcomes, which made it difficult for doctors to ascertain when to involve palliative care.
- Leadership and institution were important factors to consider in integration of palliative care into long-term care plans, which depended on leadership engagement and institutional culture.
Takeaways
The past few years have taught us a lot, but there is still much to learn. The COVID-19 pandemic has called attention to the challenges and barriers of health care delivery and has magnified the needs of the health care system including its infrastructure, preparedness, and staffing, including the field of palliative care. More work needs to be done, but leaders have taken steps to initiate national and international preparedness plans including the integration of palliative care, which has been identified as a vital role in any humanitarian crises.10,11
Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle, in the division of geriatrics and gerontology. She has no conflicts related to the content of this article.
References
1. Palliative care. World Health Organization. Aug 5, 2020. https://www.who.int/news-room/fact-sheets/detail/palliative-care
2. World Health Organization. Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: A WHO guide. Geneva: World Health Organization, 2018. https://apps.who.int/iris/handle/10665/274565.
3. Hughes MT, Smith TJ. The growth of palliative care in the United States. Annual Review Public Health. 2014;35:459-75.
4. Pastrana T et al. The impact of COVID-19 on palliative care workers across the world: A qualitative analysis of responses to open-ended questions. Palliative and Supportive Care. 2021:1-6.
5. Wentlandt K et al. Identifying barriers and facilitators to palliative care integration in the management of hospitalized patients with COVID-19: A qualitative study. Palliat Med. 2022;36(6):945-54.
6. Rogers M et al. Palliative care leadership during the pandemic: Results from a recent survey. Center to Advance Palliative Care. 2022 Sept 8. https://www.capc.org/blog/palliative-care-leadership-during-the-pandemic-results-from-a-recent-survey
7. Fogelman P. Reflections form a palliative care program leader two years into the pandemic. Center to Advance Palliative Care. 2023 Jan 15. https://www.capc.org/blog/reflections-from-a-palliative-care-program-leader-two-years-into-the-pandemic
8. 2021 survey of America’s physicians Covid-19 impact edition: A year later. The Physicians Foundation. 2021.
9. Caraceni A et al. Telemedicine for outpatient palliative care during Covid-19 pandemics: A longitudinal study. BMJ Supportive & Palliative Care. 2022;0:1-7.
10. Bausewein C et al. National strategy for palliative care of severely ill and dying people and their relatives in pandemics (PallPan) in Germany – study protocol of a mixed-methods project. BMC Palliative Care. 2022;21(10).
11. Powell RA et al. Palliative care in humanitarian crises: Always something to offer. The Lancet. 2017;389(10078):1498-9.
‘Exciting’: Post-SCT, antiviral T-cell therapy shows promise
Of 58 adult and pediatric patients with a total of 70 viral infections at the time of enrollment in the open-label trial, 55 (95%) had a treatment response within 6 weeks of infusion with posoleucel, and the amount of circulating virus was reduced by an average of 97%, Thomas Pfeiffer, MD, and colleagues reported.
In 12 patients who had more than one viral infection, 10 (83%) had a response against each of the viruses, researchers noted.
The responses were defined as a reduction of viral load to normal range with complete response, or as a viral load reduction of at least 50 percent or a partial response.
The findings were published online in Clinical Cancer Research.
Specifically, the treatment evoked responses to adenovirus in 83% of 12 affected patients, BK virus in all 27 affected patients, CMV in 96% of 24 affected patients, Epstein-Barr virus in both affected patients, and human herpes virus in 75% of 4 patients. Additionally, one patient with JC virus experienced initial stabilization of viral symptoms, although the symptoms ultimately progressed, and the patient died.
“The key finding is that 95% of patients whose infections had been refractory to conventional therapies responded to posoleucel with corresponding reductions in viral load and with limited rates of GvHD [graft-versus-host disease],” Dr. Pfeiffer, a pediatric cancer specialist at Washington University in St. Louis, explained in a prepared statement. “Overall, posoleucel was found to be very effective and had a favorable safety profile in a highly vulnerable patient population.”
“Another exciting observation from this study was that posoleucel could be administered within 24 hours in some cases, with symptom resolution in a matter of days in some patients,” added senior author Bilal Omer, MD, a pediatric hematologist-oncologist at Texas Children’s Hospital and Baylor College of Medicine, Houston. “It was quite impressive how quickly patients could be treated.”
Dr. Omer explained that currently available treatments for patients who develop viral infections after allo-SCT have numerous limitations, including toxicities such as myelosuppression or kidney injury and limited efficacy.
In this study, 13 patients (22% percent) reported acute GvHD, but only 4 of the cases were considered de novo cases; 9 patients had been diagnosed with GvHD prior to posoleucel treatment. The most common GvHD symptoms were skin flares, which were successfully treated in the majority of cases, Dr. Omer explained.
No patients experienced cytokine release syndrome.
“The ability to target six viruses with a single therapy would be beneficial for patients with multiple viral infections,” he said, adding that posoleucel is the first T-cell therapy in development for BK virus, which can cause severe bladder infections.
Posoleucel utilizes healthy donor T cells rather than the patient’s or transplant donor’s T cells, which circumvents the lengthy development process of more customized therapies and allows for earlier treatment of viral infections, he noted.
The investigators are currently evaluating posoleucel in randomized phase 3 clinical trials to confirm these findings.
This study was supported by the National Heart, Lung, and Blood Institute Production Assistance for Cellular Therapies; Conquer Cancer Foundation/American Society for Clinical Oncology; the Dan L. Duncan Comprehensive Cancer Center; and the National Institutes of Health.
Dr. Omer disclosed pending patent applications for engineered T-cell therapies unrelated to this study, and he has received research funding from AlloVir, which manufactures posoleucel. Dr. Pfeiffer declared no conflicts of interest.
Of 58 adult and pediatric patients with a total of 70 viral infections at the time of enrollment in the open-label trial, 55 (95%) had a treatment response within 6 weeks of infusion with posoleucel, and the amount of circulating virus was reduced by an average of 97%, Thomas Pfeiffer, MD, and colleagues reported.
In 12 patients who had more than one viral infection, 10 (83%) had a response against each of the viruses, researchers noted.
The responses were defined as a reduction of viral load to normal range with complete response, or as a viral load reduction of at least 50 percent or a partial response.
The findings were published online in Clinical Cancer Research.
Specifically, the treatment evoked responses to adenovirus in 83% of 12 affected patients, BK virus in all 27 affected patients, CMV in 96% of 24 affected patients, Epstein-Barr virus in both affected patients, and human herpes virus in 75% of 4 patients. Additionally, one patient with JC virus experienced initial stabilization of viral symptoms, although the symptoms ultimately progressed, and the patient died.
“The key finding is that 95% of patients whose infections had been refractory to conventional therapies responded to posoleucel with corresponding reductions in viral load and with limited rates of GvHD [graft-versus-host disease],” Dr. Pfeiffer, a pediatric cancer specialist at Washington University in St. Louis, explained in a prepared statement. “Overall, posoleucel was found to be very effective and had a favorable safety profile in a highly vulnerable patient population.”
“Another exciting observation from this study was that posoleucel could be administered within 24 hours in some cases, with symptom resolution in a matter of days in some patients,” added senior author Bilal Omer, MD, a pediatric hematologist-oncologist at Texas Children’s Hospital and Baylor College of Medicine, Houston. “It was quite impressive how quickly patients could be treated.”
Dr. Omer explained that currently available treatments for patients who develop viral infections after allo-SCT have numerous limitations, including toxicities such as myelosuppression or kidney injury and limited efficacy.
In this study, 13 patients (22% percent) reported acute GvHD, but only 4 of the cases were considered de novo cases; 9 patients had been diagnosed with GvHD prior to posoleucel treatment. The most common GvHD symptoms were skin flares, which were successfully treated in the majority of cases, Dr. Omer explained.
No patients experienced cytokine release syndrome.
“The ability to target six viruses with a single therapy would be beneficial for patients with multiple viral infections,” he said, adding that posoleucel is the first T-cell therapy in development for BK virus, which can cause severe bladder infections.
Posoleucel utilizes healthy donor T cells rather than the patient’s or transplant donor’s T cells, which circumvents the lengthy development process of more customized therapies and allows for earlier treatment of viral infections, he noted.
The investigators are currently evaluating posoleucel in randomized phase 3 clinical trials to confirm these findings.
This study was supported by the National Heart, Lung, and Blood Institute Production Assistance for Cellular Therapies; Conquer Cancer Foundation/American Society for Clinical Oncology; the Dan L. Duncan Comprehensive Cancer Center; and the National Institutes of Health.
Dr. Omer disclosed pending patent applications for engineered T-cell therapies unrelated to this study, and he has received research funding from AlloVir, which manufactures posoleucel. Dr. Pfeiffer declared no conflicts of interest.
Of 58 adult and pediatric patients with a total of 70 viral infections at the time of enrollment in the open-label trial, 55 (95%) had a treatment response within 6 weeks of infusion with posoleucel, and the amount of circulating virus was reduced by an average of 97%, Thomas Pfeiffer, MD, and colleagues reported.
In 12 patients who had more than one viral infection, 10 (83%) had a response against each of the viruses, researchers noted.
The responses were defined as a reduction of viral load to normal range with complete response, or as a viral load reduction of at least 50 percent or a partial response.
The findings were published online in Clinical Cancer Research.
Specifically, the treatment evoked responses to adenovirus in 83% of 12 affected patients, BK virus in all 27 affected patients, CMV in 96% of 24 affected patients, Epstein-Barr virus in both affected patients, and human herpes virus in 75% of 4 patients. Additionally, one patient with JC virus experienced initial stabilization of viral symptoms, although the symptoms ultimately progressed, and the patient died.
“The key finding is that 95% of patients whose infections had been refractory to conventional therapies responded to posoleucel with corresponding reductions in viral load and with limited rates of GvHD [graft-versus-host disease],” Dr. Pfeiffer, a pediatric cancer specialist at Washington University in St. Louis, explained in a prepared statement. “Overall, posoleucel was found to be very effective and had a favorable safety profile in a highly vulnerable patient population.”
“Another exciting observation from this study was that posoleucel could be administered within 24 hours in some cases, with symptom resolution in a matter of days in some patients,” added senior author Bilal Omer, MD, a pediatric hematologist-oncologist at Texas Children’s Hospital and Baylor College of Medicine, Houston. “It was quite impressive how quickly patients could be treated.”
Dr. Omer explained that currently available treatments for patients who develop viral infections after allo-SCT have numerous limitations, including toxicities such as myelosuppression or kidney injury and limited efficacy.
In this study, 13 patients (22% percent) reported acute GvHD, but only 4 of the cases were considered de novo cases; 9 patients had been diagnosed with GvHD prior to posoleucel treatment. The most common GvHD symptoms were skin flares, which were successfully treated in the majority of cases, Dr. Omer explained.
No patients experienced cytokine release syndrome.
“The ability to target six viruses with a single therapy would be beneficial for patients with multiple viral infections,” he said, adding that posoleucel is the first T-cell therapy in development for BK virus, which can cause severe bladder infections.
Posoleucel utilizes healthy donor T cells rather than the patient’s or transplant donor’s T cells, which circumvents the lengthy development process of more customized therapies and allows for earlier treatment of viral infections, he noted.
The investigators are currently evaluating posoleucel in randomized phase 3 clinical trials to confirm these findings.
This study was supported by the National Heart, Lung, and Blood Institute Production Assistance for Cellular Therapies; Conquer Cancer Foundation/American Society for Clinical Oncology; the Dan L. Duncan Comprehensive Cancer Center; and the National Institutes of Health.
Dr. Omer disclosed pending patent applications for engineered T-cell therapies unrelated to this study, and he has received research funding from AlloVir, which manufactures posoleucel. Dr. Pfeiffer declared no conflicts of interest.
FROM CLINICAL CANCER RESEARCH
Frequent visits to green spaces linked to lower use of some meds
Frequent visits to green spaces such as parks and community gardens are associated with a reduced use of certain prescription medications among city dwellers, a new analysis suggests.
In a cross-sectional cohort study, frequent green space visits were associated with less frequent use of psychotropic, antihypertensive, and asthma medications in urban environments.
Viewing green or so called “blue” spaces (views of lakes, rivers, or other water views) from the home was not associated with reduced medication use.
The growing scientific evidence supporting the health benefits of nature exposure is likely to increase the availability of high-quality green spaces in urban environments and promote the use of these spaces, lead author Anu W. Turunen, PhD, from the Finnish Institute for Health and Welfare, Kuopio, Finland, told this news organization.
This might be one way to improve health and well-being among city dwellers, Dr. Turunen added.
The findings were published online in Occupational and Environmental Medicine.
Nature exposure a timely topic
Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent, Dr. Turunen said.
“The potential health benefits of nature exposure is a very timely topic in environmental epidemiology. Scientific evidence indicates that residential exposure to greenery and water bodies might be beneficial, especially for mental, cardiovascular, and respiratory health, but the findings are partly inconsistent and thus, more detailed information is needed,” she said.
In the current cross-sectional study, the investigators surveyed 16,000 residents of three urban areas in Finland – Helsinki, Espoo, and Vantaa – over the period of 12 months from 2015 to 2016, about their exposure to green and blue spaces.
Of this number, 43% responded, resulting in 7,321 participants.
In the questionnaire, green areas were defined as forests, parks, fields, meadows, boglands, and rocks, as well as any playgrounds or playing fields within those areas, and blue areas were defined as sea, lakes, and rivers.
Residents were asked about their use of anxiolytics, hypnotics, antidepressants, antihypertensives, and asthma medication within the past 7 to 52 weeks.
They were also asked if they had any green and blue views from any of the windows of their home, and if so, how often did they look out of those windows, selecting “seldom” to “often.”
They were also asked about how much time they spent outdoors in green spaces during the months of May and September. If so, did they spend any of that time exercising? Options ranged from never to five or more times a week.
In addition, amounts of residential green and blue spaces located within a 1 km radius of the respondents’ homes were assessed from land use and land cover data.
Covariates included health behaviors, outdoor air pollution and noise, and socioeconomic status, including household income and educational attainment.
Results showed that the presence of green and blue spaces at home, and the amount of time spent viewing them, had no association with the use of the prescribed medicines.
However, greater frequency of green space visits was associated with lower odds of using the medications surveyed.
For psychotropic medications, the odds ratios were 0.67 (95% confidence interval, 0.55-0.82) for 3-4 times per week and 0.78 (95% CI, 0.63-0.96) for 5 or more times per week.
For antihypertensive meds, the ORs were 0.64 (95% CI, 0.52-0.78) for 3-4 times per week and 0.59 (95% CI, 0.48-0.74) for 5 or more times per week.
For asthma medications, the ORs were 0.74 (95% CI, 0.58-0.94) for 3-4 times per week and 0.76 (95% CI, 0.59-0.99) for 5 or more times per week.
The observed associations were attenuated by body mass index.
“We observed that those who reported visiting green spaces often had a slightly lower BMI than those who visited green spaces less often,” Dr. Turunen said. However, no consistent interactions with socioeconomic status indicators were observed.
“We are hoping to see new results from different countries and different settings,” she noted. “Longitudinal studies, especially, are needed. In epidemiology, a large body of consistent evidence is needed to draw strong conclusions and to make recommendations.”
Evidence mounts on the benefits of nature
There is growing evidence that exposure to nature could benefit human health, especially mental and cardiovascular health, says Jochem Klompmaker, PhD, a postdoctoral researcher in the department of environmental health at the Harvard T.H. Chan School of Public Health, Boston.
Dr. Klompmaker has researched the association between exposure to green spaces and health outcomes related to neurological diseases.
In a study recently published in JAMA Network Open, and reported by this news organization, Dr. Klompmaker and his team found that among a large cohort of about 6.7 million fee-for-service Medicare beneficiaries in the United States aged 65 or older, living in areas rich with greenery, parks, and waterways was associated with fewer hospitalizations for certain neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and related dementias.
Commenting on the current study, Dr. Klompmaker noted its strengths.
“A particular strength of this study is that they used data about the amount of green and blue spaces around the residential addresses of the participants, data about green space visit frequency, and data about green and blue views from home. Most other studies only have data about the amount of green and blue spaces in general,” he said.
“The strong protective associations of frequency of green space visits make sense to me and indicate the importance of one’s actual nature exposure,” he added. “Like the results of our study, these results provide clinicians with more evidence of the importance of being close to nature and of encouraging patients to take more walks. If they live near a park, that could be a good place to be more physically active and reduce stress levels.”
The study was supported by the Academy of Finland and the Ministry of the Environment. Dr. Turunen and Dr. Klompmaker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Frequent visits to green spaces such as parks and community gardens are associated with a reduced use of certain prescription medications among city dwellers, a new analysis suggests.
In a cross-sectional cohort study, frequent green space visits were associated with less frequent use of psychotropic, antihypertensive, and asthma medications in urban environments.
Viewing green or so called “blue” spaces (views of lakes, rivers, or other water views) from the home was not associated with reduced medication use.
The growing scientific evidence supporting the health benefits of nature exposure is likely to increase the availability of high-quality green spaces in urban environments and promote the use of these spaces, lead author Anu W. Turunen, PhD, from the Finnish Institute for Health and Welfare, Kuopio, Finland, told this news organization.
This might be one way to improve health and well-being among city dwellers, Dr. Turunen added.
The findings were published online in Occupational and Environmental Medicine.
Nature exposure a timely topic
Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent, Dr. Turunen said.
“The potential health benefits of nature exposure is a very timely topic in environmental epidemiology. Scientific evidence indicates that residential exposure to greenery and water bodies might be beneficial, especially for mental, cardiovascular, and respiratory health, but the findings are partly inconsistent and thus, more detailed information is needed,” she said.
In the current cross-sectional study, the investigators surveyed 16,000 residents of three urban areas in Finland – Helsinki, Espoo, and Vantaa – over the period of 12 months from 2015 to 2016, about their exposure to green and blue spaces.
Of this number, 43% responded, resulting in 7,321 participants.
In the questionnaire, green areas were defined as forests, parks, fields, meadows, boglands, and rocks, as well as any playgrounds or playing fields within those areas, and blue areas were defined as sea, lakes, and rivers.
Residents were asked about their use of anxiolytics, hypnotics, antidepressants, antihypertensives, and asthma medication within the past 7 to 52 weeks.
They were also asked if they had any green and blue views from any of the windows of their home, and if so, how often did they look out of those windows, selecting “seldom” to “often.”
They were also asked about how much time they spent outdoors in green spaces during the months of May and September. If so, did they spend any of that time exercising? Options ranged from never to five or more times a week.
In addition, amounts of residential green and blue spaces located within a 1 km radius of the respondents’ homes were assessed from land use and land cover data.
Covariates included health behaviors, outdoor air pollution and noise, and socioeconomic status, including household income and educational attainment.
Results showed that the presence of green and blue spaces at home, and the amount of time spent viewing them, had no association with the use of the prescribed medicines.
However, greater frequency of green space visits was associated with lower odds of using the medications surveyed.
For psychotropic medications, the odds ratios were 0.67 (95% confidence interval, 0.55-0.82) for 3-4 times per week and 0.78 (95% CI, 0.63-0.96) for 5 or more times per week.
For antihypertensive meds, the ORs were 0.64 (95% CI, 0.52-0.78) for 3-4 times per week and 0.59 (95% CI, 0.48-0.74) for 5 or more times per week.
For asthma medications, the ORs were 0.74 (95% CI, 0.58-0.94) for 3-4 times per week and 0.76 (95% CI, 0.59-0.99) for 5 or more times per week.
The observed associations were attenuated by body mass index.
“We observed that those who reported visiting green spaces often had a slightly lower BMI than those who visited green spaces less often,” Dr. Turunen said. However, no consistent interactions with socioeconomic status indicators were observed.
“We are hoping to see new results from different countries and different settings,” she noted. “Longitudinal studies, especially, are needed. In epidemiology, a large body of consistent evidence is needed to draw strong conclusions and to make recommendations.”
Evidence mounts on the benefits of nature
There is growing evidence that exposure to nature could benefit human health, especially mental and cardiovascular health, says Jochem Klompmaker, PhD, a postdoctoral researcher in the department of environmental health at the Harvard T.H. Chan School of Public Health, Boston.
Dr. Klompmaker has researched the association between exposure to green spaces and health outcomes related to neurological diseases.
In a study recently published in JAMA Network Open, and reported by this news organization, Dr. Klompmaker and his team found that among a large cohort of about 6.7 million fee-for-service Medicare beneficiaries in the United States aged 65 or older, living in areas rich with greenery, parks, and waterways was associated with fewer hospitalizations for certain neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and related dementias.
Commenting on the current study, Dr. Klompmaker noted its strengths.
“A particular strength of this study is that they used data about the amount of green and blue spaces around the residential addresses of the participants, data about green space visit frequency, and data about green and blue views from home. Most other studies only have data about the amount of green and blue spaces in general,” he said.
“The strong protective associations of frequency of green space visits make sense to me and indicate the importance of one’s actual nature exposure,” he added. “Like the results of our study, these results provide clinicians with more evidence of the importance of being close to nature and of encouraging patients to take more walks. If they live near a park, that could be a good place to be more physically active and reduce stress levels.”
The study was supported by the Academy of Finland and the Ministry of the Environment. Dr. Turunen and Dr. Klompmaker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Frequent visits to green spaces such as parks and community gardens are associated with a reduced use of certain prescription medications among city dwellers, a new analysis suggests.
In a cross-sectional cohort study, frequent green space visits were associated with less frequent use of psychotropic, antihypertensive, and asthma medications in urban environments.
Viewing green or so called “blue” spaces (views of lakes, rivers, or other water views) from the home was not associated with reduced medication use.
The growing scientific evidence supporting the health benefits of nature exposure is likely to increase the availability of high-quality green spaces in urban environments and promote the use of these spaces, lead author Anu W. Turunen, PhD, from the Finnish Institute for Health and Welfare, Kuopio, Finland, told this news organization.
This might be one way to improve health and well-being among city dwellers, Dr. Turunen added.
The findings were published online in Occupational and Environmental Medicine.
Nature exposure a timely topic
Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent, Dr. Turunen said.
“The potential health benefits of nature exposure is a very timely topic in environmental epidemiology. Scientific evidence indicates that residential exposure to greenery and water bodies might be beneficial, especially for mental, cardiovascular, and respiratory health, but the findings are partly inconsistent and thus, more detailed information is needed,” she said.
In the current cross-sectional study, the investigators surveyed 16,000 residents of three urban areas in Finland – Helsinki, Espoo, and Vantaa – over the period of 12 months from 2015 to 2016, about their exposure to green and blue spaces.
Of this number, 43% responded, resulting in 7,321 participants.
In the questionnaire, green areas were defined as forests, parks, fields, meadows, boglands, and rocks, as well as any playgrounds or playing fields within those areas, and blue areas were defined as sea, lakes, and rivers.
Residents were asked about their use of anxiolytics, hypnotics, antidepressants, antihypertensives, and asthma medication within the past 7 to 52 weeks.
They were also asked if they had any green and blue views from any of the windows of their home, and if so, how often did they look out of those windows, selecting “seldom” to “often.”
They were also asked about how much time they spent outdoors in green spaces during the months of May and September. If so, did they spend any of that time exercising? Options ranged from never to five or more times a week.
In addition, amounts of residential green and blue spaces located within a 1 km radius of the respondents’ homes were assessed from land use and land cover data.
Covariates included health behaviors, outdoor air pollution and noise, and socioeconomic status, including household income and educational attainment.
Results showed that the presence of green and blue spaces at home, and the amount of time spent viewing them, had no association with the use of the prescribed medicines.
However, greater frequency of green space visits was associated with lower odds of using the medications surveyed.
For psychotropic medications, the odds ratios were 0.67 (95% confidence interval, 0.55-0.82) for 3-4 times per week and 0.78 (95% CI, 0.63-0.96) for 5 or more times per week.
For antihypertensive meds, the ORs were 0.64 (95% CI, 0.52-0.78) for 3-4 times per week and 0.59 (95% CI, 0.48-0.74) for 5 or more times per week.
For asthma medications, the ORs were 0.74 (95% CI, 0.58-0.94) for 3-4 times per week and 0.76 (95% CI, 0.59-0.99) for 5 or more times per week.
The observed associations were attenuated by body mass index.
“We observed that those who reported visiting green spaces often had a slightly lower BMI than those who visited green spaces less often,” Dr. Turunen said. However, no consistent interactions with socioeconomic status indicators were observed.
“We are hoping to see new results from different countries and different settings,” she noted. “Longitudinal studies, especially, are needed. In epidemiology, a large body of consistent evidence is needed to draw strong conclusions and to make recommendations.”
Evidence mounts on the benefits of nature
There is growing evidence that exposure to nature could benefit human health, especially mental and cardiovascular health, says Jochem Klompmaker, PhD, a postdoctoral researcher in the department of environmental health at the Harvard T.H. Chan School of Public Health, Boston.
Dr. Klompmaker has researched the association between exposure to green spaces and health outcomes related to neurological diseases.
In a study recently published in JAMA Network Open, and reported by this news organization, Dr. Klompmaker and his team found that among a large cohort of about 6.7 million fee-for-service Medicare beneficiaries in the United States aged 65 or older, living in areas rich with greenery, parks, and waterways was associated with fewer hospitalizations for certain neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and related dementias.
Commenting on the current study, Dr. Klompmaker noted its strengths.
“A particular strength of this study is that they used data about the amount of green and blue spaces around the residential addresses of the participants, data about green space visit frequency, and data about green and blue views from home. Most other studies only have data about the amount of green and blue spaces in general,” he said.
“The strong protective associations of frequency of green space visits make sense to me and indicate the importance of one’s actual nature exposure,” he added. “Like the results of our study, these results provide clinicians with more evidence of the importance of being close to nature and of encouraging patients to take more walks. If they live near a park, that could be a good place to be more physically active and reduce stress levels.”
The study was supported by the Academy of Finland and the Ministry of the Environment. Dr. Turunen and Dr. Klompmaker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Legacy ICDs exposed to MRI still shock, pace as needed
Functions like sensing and pacing in implantable cardioverter defibrillators (ICDs) tend to resist interference from the energy fields generated by MRI, as long as device programming is properly adjusted before the scan.
That applies even to patients with older “legacy” devices implanted before the 2015 advent of MRI-conditional ICDs despite, in practice, prevalent but misguided resistance to obtaining MRI scans in such cases.
Less is known whether such non–MRI-conditional devices, once exposed to MRI, will then reliably deliver antiarrhythmic shocks or antitachycardia pacing (ATP) when needed.
A new cohort study has tried to fill in some of that knowledge gap. It showed no evidence of an excess risk for death or ICD failure to deliver therapy within about 2 years of clinically indicated MRI scans in 629 patients with non–MRI-conditional devices.
The findings, published online in the Annals of Internal Medicine, come with caveats. For example, they’re based on the experience of one, albeit major, center and on MRIs that were for varied indications using 1.5-tesla equipment only.
Despite such safety evidence for appropriately adjusted non–MRI-conditional ICDs, many patients with the devices don›t receive clinically indicated MRI scans due to “perceived risk” that the ICDs won’t then reliably deliver appropriate therapy, observe the authors, led by Joshua Ra, MD, University of California, San Francisco.
Any such risks are “largely theoretical,” but may still explain “why some institutions are shying away from offering MRI exams” to patients with non–MRI-conditional ICDs, Dr. Ra told this news organization.
Many such hospitals refer such patients to more experienced centers, creating “significant logistical barriers in terms of patient access to these MRIs,” he said. “That seems to still be prevalent, unfortunately.”
The current findings “provide another layer of reassurance” that MRI scans in patients with non–MRI-conditional ICDs don’t impair a device’s ability to deliver shocks or ATP, Dr. Ra said.
The cohort consisted of 629 patients with non–MRI-conditional ICDs who underwent 813 clinically indicated MRI exams from 2003 to early 2015 at Johns Hopkins University, Baltimore.
Scans performed within 4 weeks of device implantation were excluded because, the report notes, that’s when spontaneous lead dislodgements or changes to device parameters are most likely to occur. Also excluded were patients with permanent epicardial leads, abandoned leads, or subcutaneous ICD lead systems, the report states.
Still, Dr. Ra said, the cohort is fairly representative of “the modern patient population” of non–MRI-conditional ICD recipients.
A total of 4,177 arrhythmia episodes were documented during a median 2.2 years between scans and last device interrogation prior to pulse-generator change-out or lead exchange.
Of note, Dr. Ra observed, the arrhythmias were confirmed in only 85% of the cohort. Most of the remainder were referral patients who were lost to follow-up whose devices were unavailable for interrogation.
Device therapy terminated “nearly all” documented spontaneous arrhythmias in that 85% of patients, the report states. They included 757 episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), including 130 that were shocked and the remainder that were managed with ATP. There were also 105 supraventricular tachycardias, all successfully terminated with shocks.
There were no cases of VT or VF detection delay from undersensing or instances of syncope because of “abnormalities” in device detection of arrhythmias, the report states.
Of the 210 known deaths, which occurred a median 1.7 years after the scan, about half were noncardiac and more than a third were cardiac but nonarrhythmic.
Ten patients died from arrhythmia-related cardiac causes, representing 5% of deaths; but 7% of deaths were of undetermined cause.
“No direct relationship of deaths attributable to prior MRI exposure was found or reported,” the report states.
The researchers informally compared outcomes between older and more recently implanted non–MRI-conditional ICDs, the latter presumably with more modern design features. Their data, based on device interrogations, Dr. Ra said, “seem to suggest there were no differences.”
The study was supported by Johns Hopkins University and the National Institutes of Health. Author disclosures are available at apconline.org.
A version of this article first appeared on Medscape.com.
Functions like sensing and pacing in implantable cardioverter defibrillators (ICDs) tend to resist interference from the energy fields generated by MRI, as long as device programming is properly adjusted before the scan.
That applies even to patients with older “legacy” devices implanted before the 2015 advent of MRI-conditional ICDs despite, in practice, prevalent but misguided resistance to obtaining MRI scans in such cases.
Less is known whether such non–MRI-conditional devices, once exposed to MRI, will then reliably deliver antiarrhythmic shocks or antitachycardia pacing (ATP) when needed.
A new cohort study has tried to fill in some of that knowledge gap. It showed no evidence of an excess risk for death or ICD failure to deliver therapy within about 2 years of clinically indicated MRI scans in 629 patients with non–MRI-conditional devices.
The findings, published online in the Annals of Internal Medicine, come with caveats. For example, they’re based on the experience of one, albeit major, center and on MRIs that were for varied indications using 1.5-tesla equipment only.
Despite such safety evidence for appropriately adjusted non–MRI-conditional ICDs, many patients with the devices don›t receive clinically indicated MRI scans due to “perceived risk” that the ICDs won’t then reliably deliver appropriate therapy, observe the authors, led by Joshua Ra, MD, University of California, San Francisco.
Any such risks are “largely theoretical,” but may still explain “why some institutions are shying away from offering MRI exams” to patients with non–MRI-conditional ICDs, Dr. Ra told this news organization.
Many such hospitals refer such patients to more experienced centers, creating “significant logistical barriers in terms of patient access to these MRIs,” he said. “That seems to still be prevalent, unfortunately.”
The current findings “provide another layer of reassurance” that MRI scans in patients with non–MRI-conditional ICDs don’t impair a device’s ability to deliver shocks or ATP, Dr. Ra said.
The cohort consisted of 629 patients with non–MRI-conditional ICDs who underwent 813 clinically indicated MRI exams from 2003 to early 2015 at Johns Hopkins University, Baltimore.
Scans performed within 4 weeks of device implantation were excluded because, the report notes, that’s when spontaneous lead dislodgements or changes to device parameters are most likely to occur. Also excluded were patients with permanent epicardial leads, abandoned leads, or subcutaneous ICD lead systems, the report states.
Still, Dr. Ra said, the cohort is fairly representative of “the modern patient population” of non–MRI-conditional ICD recipients.
A total of 4,177 arrhythmia episodes were documented during a median 2.2 years between scans and last device interrogation prior to pulse-generator change-out or lead exchange.
Of note, Dr. Ra observed, the arrhythmias were confirmed in only 85% of the cohort. Most of the remainder were referral patients who were lost to follow-up whose devices were unavailable for interrogation.
Device therapy terminated “nearly all” documented spontaneous arrhythmias in that 85% of patients, the report states. They included 757 episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), including 130 that were shocked and the remainder that were managed with ATP. There were also 105 supraventricular tachycardias, all successfully terminated with shocks.
There were no cases of VT or VF detection delay from undersensing or instances of syncope because of “abnormalities” in device detection of arrhythmias, the report states.
Of the 210 known deaths, which occurred a median 1.7 years after the scan, about half were noncardiac and more than a third were cardiac but nonarrhythmic.
Ten patients died from arrhythmia-related cardiac causes, representing 5% of deaths; but 7% of deaths were of undetermined cause.
“No direct relationship of deaths attributable to prior MRI exposure was found or reported,” the report states.
The researchers informally compared outcomes between older and more recently implanted non–MRI-conditional ICDs, the latter presumably with more modern design features. Their data, based on device interrogations, Dr. Ra said, “seem to suggest there were no differences.”
The study was supported by Johns Hopkins University and the National Institutes of Health. Author disclosures are available at apconline.org.
A version of this article first appeared on Medscape.com.
Functions like sensing and pacing in implantable cardioverter defibrillators (ICDs) tend to resist interference from the energy fields generated by MRI, as long as device programming is properly adjusted before the scan.
That applies even to patients with older “legacy” devices implanted before the 2015 advent of MRI-conditional ICDs despite, in practice, prevalent but misguided resistance to obtaining MRI scans in such cases.
Less is known whether such non–MRI-conditional devices, once exposed to MRI, will then reliably deliver antiarrhythmic shocks or antitachycardia pacing (ATP) when needed.
A new cohort study has tried to fill in some of that knowledge gap. It showed no evidence of an excess risk for death or ICD failure to deliver therapy within about 2 years of clinically indicated MRI scans in 629 patients with non–MRI-conditional devices.
The findings, published online in the Annals of Internal Medicine, come with caveats. For example, they’re based on the experience of one, albeit major, center and on MRIs that were for varied indications using 1.5-tesla equipment only.
Despite such safety evidence for appropriately adjusted non–MRI-conditional ICDs, many patients with the devices don›t receive clinically indicated MRI scans due to “perceived risk” that the ICDs won’t then reliably deliver appropriate therapy, observe the authors, led by Joshua Ra, MD, University of California, San Francisco.
Any such risks are “largely theoretical,” but may still explain “why some institutions are shying away from offering MRI exams” to patients with non–MRI-conditional ICDs, Dr. Ra told this news organization.
Many such hospitals refer such patients to more experienced centers, creating “significant logistical barriers in terms of patient access to these MRIs,” he said. “That seems to still be prevalent, unfortunately.”
The current findings “provide another layer of reassurance” that MRI scans in patients with non–MRI-conditional ICDs don’t impair a device’s ability to deliver shocks or ATP, Dr. Ra said.
The cohort consisted of 629 patients with non–MRI-conditional ICDs who underwent 813 clinically indicated MRI exams from 2003 to early 2015 at Johns Hopkins University, Baltimore.
Scans performed within 4 weeks of device implantation were excluded because, the report notes, that’s when spontaneous lead dislodgements or changes to device parameters are most likely to occur. Also excluded were patients with permanent epicardial leads, abandoned leads, or subcutaneous ICD lead systems, the report states.
Still, Dr. Ra said, the cohort is fairly representative of “the modern patient population” of non–MRI-conditional ICD recipients.
A total of 4,177 arrhythmia episodes were documented during a median 2.2 years between scans and last device interrogation prior to pulse-generator change-out or lead exchange.
Of note, Dr. Ra observed, the arrhythmias were confirmed in only 85% of the cohort. Most of the remainder were referral patients who were lost to follow-up whose devices were unavailable for interrogation.
Device therapy terminated “nearly all” documented spontaneous arrhythmias in that 85% of patients, the report states. They included 757 episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), including 130 that were shocked and the remainder that were managed with ATP. There were also 105 supraventricular tachycardias, all successfully terminated with shocks.
There were no cases of VT or VF detection delay from undersensing or instances of syncope because of “abnormalities” in device detection of arrhythmias, the report states.
Of the 210 known deaths, which occurred a median 1.7 years after the scan, about half were noncardiac and more than a third were cardiac but nonarrhythmic.
Ten patients died from arrhythmia-related cardiac causes, representing 5% of deaths; but 7% of deaths were of undetermined cause.
“No direct relationship of deaths attributable to prior MRI exposure was found or reported,” the report states.
The researchers informally compared outcomes between older and more recently implanted non–MRI-conditional ICDs, the latter presumably with more modern design features. Their data, based on device interrogations, Dr. Ra said, “seem to suggest there were no differences.”
The study was supported by Johns Hopkins University and the National Institutes of Health. Author disclosures are available at apconline.org.
A version of this article first appeared on Medscape.com.
AGA’s GI Opportunity Fund invests in EndoSound®
EndoSound is an Oregon-based medical device innovator developing technology that enhances access, reduces costs, and increases the safety of endoscopic ultrasound (EUS) procedures.
The EndoSound Vision System® (EVS®) is a disruptive EUS platform. Its attachable transducer and supportive components transform a conventional upper endoscope into a fully functional endoscopic ultrasound device. The cost of existing EUS systems has limited the availability of this crucial modality in the United States and around the world.
By reducing this cost, the EVS will provide physicians with a technological option that can enable care for their patients in a greater number of locations and settings. This brings the potential for enormous benefits to patients, payers, and providers by reducing costs in the healthcare system.
EndoSound is an Oregon-based medical device innovator developing technology that enhances access, reduces costs, and increases the safety of endoscopic ultrasound (EUS) procedures.
The EndoSound Vision System® (EVS®) is a disruptive EUS platform. Its attachable transducer and supportive components transform a conventional upper endoscope into a fully functional endoscopic ultrasound device. The cost of existing EUS systems has limited the availability of this crucial modality in the United States and around the world.
By reducing this cost, the EVS will provide physicians with a technological option that can enable care for their patients in a greater number of locations and settings. This brings the potential for enormous benefits to patients, payers, and providers by reducing costs in the healthcare system.
EndoSound is an Oregon-based medical device innovator developing technology that enhances access, reduces costs, and increases the safety of endoscopic ultrasound (EUS) procedures.
The EndoSound Vision System® (EVS®) is a disruptive EUS platform. Its attachable transducer and supportive components transform a conventional upper endoscope into a fully functional endoscopic ultrasound device. The cost of existing EUS systems has limited the availability of this crucial modality in the United States and around the world.
By reducing this cost, the EVS will provide physicians with a technological option that can enable care for their patients in a greater number of locations and settings. This brings the potential for enormous benefits to patients, payers, and providers by reducing costs in the healthcare system.
The new blood pressure target in primary care
This transcript has been edited for clarity.
I’m Dr. Neil Skolnik. There are very few things that we treat more often than hypertension, so you’d think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 (Eighth Joint National Committee) recommended target blood pressure for individuals under 60 to be less than 140/90, and for those older than 60, less than 150/90.
Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association’s hypertension guidelines lowered the target BP to less than 130/80 for most individuals. It’s a little more nuanced than that, but most of us don’t remember the nuance. I’ve written about my reservations with that statement in the AHA’s journal, Circulation.
Now the American Academy of Family Physicians has updated its recommendations, and they recommend a BP less than 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I’m going share with you some details from the new guideline, and then I’m going share my opinion about it.
The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.
The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn’t reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3%, compared with the standard target group (specifically 9.8% vs. 6.8%), with a number needed to harm of 33 over 3.7 years.
Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate because of adverse events in the lower-target BP groups.
The AAFP guidelines said that, in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction – a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.
So that’s the background. Let me now go over the specifics of the AAFP recommendations.
AAFP gives a strong recommendation for a standard BP target of less than 140/90. They go on to say – and grade this next statement as a weak recommendation – that, while treating to a lower BP target does not provide additional mortality benefit, a target BP of less than 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.
The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies – American Heart Association and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which included only high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.
In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.
Interestingly, the International Society of Hypertension recommends an “essential” BP target of less than 140/90 for most individuals, and for those under 65, they provide the option of an “optimal” BP of less than 130/80. Remember that for certain comorbidities there are also other guidelines out there. The American Diabetes Association this year revised its target BP to less than 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP less than 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of less than 130/80 for those with established atherosclerotic cardiovascular disease.
To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP less than 140/90.
Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.
A version of this article first appeared on Medscape.com.
*This article was updated on 2/7/2023.
This transcript has been edited for clarity.
I’m Dr. Neil Skolnik. There are very few things that we treat more often than hypertension, so you’d think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 (Eighth Joint National Committee) recommended target blood pressure for individuals under 60 to be less than 140/90, and for those older than 60, less than 150/90.
Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association’s hypertension guidelines lowered the target BP to less than 130/80 for most individuals. It’s a little more nuanced than that, but most of us don’t remember the nuance. I’ve written about my reservations with that statement in the AHA’s journal, Circulation.
Now the American Academy of Family Physicians has updated its recommendations, and they recommend a BP less than 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I’m going share with you some details from the new guideline, and then I’m going share my opinion about it.
The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.
The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn’t reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3%, compared with the standard target group (specifically 9.8% vs. 6.8%), with a number needed to harm of 33 over 3.7 years.
Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate because of adverse events in the lower-target BP groups.
The AAFP guidelines said that, in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction – a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.
So that’s the background. Let me now go over the specifics of the AAFP recommendations.
AAFP gives a strong recommendation for a standard BP target of less than 140/90. They go on to say – and grade this next statement as a weak recommendation – that, while treating to a lower BP target does not provide additional mortality benefit, a target BP of less than 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.
The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies – American Heart Association and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which included only high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.
In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.
Interestingly, the International Society of Hypertension recommends an “essential” BP target of less than 140/90 for most individuals, and for those under 65, they provide the option of an “optimal” BP of less than 130/80. Remember that for certain comorbidities there are also other guidelines out there. The American Diabetes Association this year revised its target BP to less than 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP less than 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of less than 130/80 for those with established atherosclerotic cardiovascular disease.
To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP less than 140/90.
Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.
A version of this article first appeared on Medscape.com.
*This article was updated on 2/7/2023.
This transcript has been edited for clarity.
I’m Dr. Neil Skolnik. There are very few things that we treat more often than hypertension, so you’d think the guidelines would have been clear a long time ago. Less than 10 years ago, in 2014, JNC 8 (Eighth Joint National Committee) recommended target blood pressure for individuals under 60 to be less than 140/90, and for those older than 60, less than 150/90.
Then, based primarily on the SPRINT trial (which included only people with or at significantly elevated risk for atherosclerotic cardiovascular disease), in 2017 the American Heart Association’s hypertension guidelines lowered the target BP to less than 130/80 for most individuals. It’s a little more nuanced than that, but most of us don’t remember the nuance. I’ve written about my reservations with that statement in the AHA’s journal, Circulation.
Now the American Academy of Family Physicians has updated its recommendations, and they recommend a BP less than 140/90. This is not a small change, as it often takes additional medication to achieve lower BP targets, and additional medicines lead to additional adverse effects. I’m going share with you some details from the new guideline, and then I’m going share my opinion about it.
The AAFP guideline applies to adults with hypertension, with or without cardiovascular disease. In the comprehensive literature review, the trials ran for an average of 3.7 years, and about 75% of the patients in the trials did not have preexisting cardiovascular disease.
The key to their recommendations is that target BPs lower than 140/90 did not show a statistically significant decrease in total mortality. In regard to serious adverse events, though, lower targets led to a nominal increase that didn’t reach statistical significance. Serious adverse events were defined as death or events that required hospitalization or resulted in significant disability. In regard to all other adverse events, including syncope and hypotension, there was a significant increase, with a relative risk of 1.44 (a 44% increase in adverse events). This reflected an absolute risk increase of 3%, compared with the standard target group (specifically 9.8% vs. 6.8%), with a number needed to harm of 33 over 3.7 years.
Another potential harm of low BP targets was the need for an average of one additional medicine to reach lower BP targets. One systematic review cited an eightfold higher withdrawal rate because of adverse events in the lower-target BP groups.
The AAFP guidelines said that, in the comprehensive review of the literature, while there was no difference in mortality or stroke with lower BP targets, a small additional benefit was observed in myocardial infarction – a 16% lower incidence, with a number needed to treat of 137 over 3.7 years.
So that’s the background. Let me now go over the specifics of the AAFP recommendations.
AAFP gives a strong recommendation for a standard BP target of less than 140/90. They go on to say – and grade this next statement as a weak recommendation – that, while treating to a lower BP target does not provide additional mortality benefit, a target BP of less than 135/85 can be considered to lower the risk for MI, noting that lower BP may increase harms. They state that the lower BP target could be considered based on patient preferences and values.
The AAFP guideline is incredibly helpful. The difference in the recommendations of two large societies – American Heart Association and AAFP — stems from two things. I believe that AHA focused on the composite endpoints in trials such as SPRINT, which included only high-risk patients, and the AAFP uses mortality as the driving endpoint in a broader group of patients that included both high- and lower-risk patients.
In addition, it appears that the two organizations weigh adverse events differently in coming to their conclusions. Clearly, we see more adverse events when aiming for a lower BP level, and in my experience, patients care a lot about adverse events.
Interestingly, the International Society of Hypertension recommends an “essential” BP target of less than 140/90 for most individuals, and for those under 65, they provide the option of an “optimal” BP of less than 130/80. Remember that for certain comorbidities there are also other guidelines out there. The American Diabetes Association this year revised its target BP to less than 130/80 for people with diabetes; for prevention of recurrent stroke, guidelines from the AHA/American Stroke Association in 2021 recommend BP less than 130/80, and the International Society for Hypertension as well as the AHA recommends a BP of less than 130/80 for those with established atherosclerotic cardiovascular disease.
To repeat, though, the main topic for today is that as a general target, the AAFP guidelines recommend a BP less than 140/90.
Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed conflicts of interest with AstraZeneca, Teva, Eli Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GlaxoSmithKline, Merck, and Bayer.
A version of this article first appeared on Medscape.com.
*This article was updated on 2/7/2023.
More data back Guillain-Barré risk with Janssen COVID shot
Over 14 months, GBS reporting rates within 21 and 42 days of administration of Janssen’s replication-incompetent adenoviral vector vaccine were approximately 9 to 12 times higher than after administration of the Pfizer-BioNTech (BNT162b2) or the Moderna (mRNA-1273) mRNA COVID vaccines.
Additionally, observed GBS cases after the Janssen shot were 2 to 3 times greater than expected, based on background rates within 21 and 42 days of vaccination.
Conversely, and confirming prior data, there was no increased risk for GBS with the Pfizer or Moderna vaccines and no significant difference between observed and expected numbers of GBS cases after either mRNA COVID-19 vaccine.
The findings were published online in JAMA Network Open.
More precise risk estimates
Winston Abara, MD, with the U.S. Centers for Disease Control and Prevention, and colleagues analyzed GBS reports submitted to the VAERS between December 2020 and January 2022.
Among 487.6 million COVID-19 vaccine doses administered, 3.7% were Janssen’s Ad26.COV2.S vaccine, 54.7% were Pfizer’s BNT162b2 vaccine, and 41.6% were Moderna’s mRNA-1273 vaccine.
There were 295 verified reports of GBS identified after COVID-19 vaccination. Of these, 209 occurred within 21 days of vaccination and 253 within 42 days.
Within 21 days of vaccination, GBS reporting rates per 1 million doses were 3.29 for the Janssen vaccine versus 0.29 and 0.35 for the Pfizer and Moderna vaccines, respectively. Within 42 days of vaccination, reporting rates per 1 million doses were 4.07, 0.34, and 0.44, respectively.
Also within 21 days of vaccination, GBS reporting rates were significantly higher with the Janssen vaccine than the Pfizer vaccine (reporting rate ratio, 11.40) and the Moderna vaccine (RRR, 9.26). Similar findings were observed within 42 days after vaccination.
The observed-to-expected ratios were 3.79 for 21-day and 2.34 for 42-day intervals after receipt of the Janssen vaccine, and less than 1 (not significant) after the Pfizer or Moderna vaccine within both post-vaccination periods.
“Unlike prior studies, our analysis included all U.S. reports of verified GBS cases that met the Brighton Collaboration GBS case definition criteria (Brighton Levels 1, 2, and 3) submitted over a 14-month surveillance period to the to the Vaccine Adverse Event Reporting System,” Dr. Abara said in an interview. “Because we used all U.S. reports, the sample of verified GBS cases in this analysis is larger than other studies. Therefore, it may provide a more precise estimate of the GBS risk within 21 and 42 days after mRNA and Ad26.COV2.S vaccination,” he said.
‘Remarkably low’ use
Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, Calif., noted that this is a “nice confirmatory analysis that supports and further expands what’s been observed before.”
Last year, as reported by this news organization, Dr. Klein and colleagues reported data from the Vaccine Safety Datalink confirming a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Janssen COVID-19 vaccine but not the Pfizer or Moderna vaccines.
Unlike VAERS, the Vaccine Safety Datalink is not a reporting system. It’s an active surveillance of medical records in the Kaiser Permanente system. The VAERS is a passive system, so it requires individuals to report GBS cases to the VAERS team, Dr. Klein explained.
So although the two studies are slightly different, overall, the VAERS data is “consistent with what we found,” she said.
Also weighing in, C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and professor of pediatrics at the Vanderbilt University School of Medicine, Nashville, Tenn., said it is “important to realize that GBS had been observed after adenovirus-vectored vaccines earlier in the pandemic, both for the AstraZeneca vaccine and the Janssen vaccine.”
The Advisory Committee on Immunization Practices (ACIP) preferentially recommends that people age 18 years and older receive an mRNA COVID-19 vaccine rather than the Janssen adenoviral vector vaccine when both types of COVID-19 vaccine are available.
“Thus, the use of the Janssen vaccine is remarkably low in the U.S. right now,” Dr. Creech said.
“Nevertheless, we have a firm commitment, both scientifically and ethically, to track potential side effects after vaccination and to make sure that the vaccines in use for COVID, and other important infectious diseases, are safe and effective,” he added.
The study had no commercial funding. Dr. Abara and Dr. Creech have reported no relevant financial relationships. Dr. Klein reported having received grants from Pfizer research support for a COVID vaccine clinical trial, as well as grants from Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur).
A version of this article first appeared on Medscape.com.
Over 14 months, GBS reporting rates within 21 and 42 days of administration of Janssen’s replication-incompetent adenoviral vector vaccine were approximately 9 to 12 times higher than after administration of the Pfizer-BioNTech (BNT162b2) or the Moderna (mRNA-1273) mRNA COVID vaccines.
Additionally, observed GBS cases after the Janssen shot were 2 to 3 times greater than expected, based on background rates within 21 and 42 days of vaccination.
Conversely, and confirming prior data, there was no increased risk for GBS with the Pfizer or Moderna vaccines and no significant difference between observed and expected numbers of GBS cases after either mRNA COVID-19 vaccine.
The findings were published online in JAMA Network Open.
More precise risk estimates
Winston Abara, MD, with the U.S. Centers for Disease Control and Prevention, and colleagues analyzed GBS reports submitted to the VAERS between December 2020 and January 2022.
Among 487.6 million COVID-19 vaccine doses administered, 3.7% were Janssen’s Ad26.COV2.S vaccine, 54.7% were Pfizer’s BNT162b2 vaccine, and 41.6% were Moderna’s mRNA-1273 vaccine.
There were 295 verified reports of GBS identified after COVID-19 vaccination. Of these, 209 occurred within 21 days of vaccination and 253 within 42 days.
Within 21 days of vaccination, GBS reporting rates per 1 million doses were 3.29 for the Janssen vaccine versus 0.29 and 0.35 for the Pfizer and Moderna vaccines, respectively. Within 42 days of vaccination, reporting rates per 1 million doses were 4.07, 0.34, and 0.44, respectively.
Also within 21 days of vaccination, GBS reporting rates were significantly higher with the Janssen vaccine than the Pfizer vaccine (reporting rate ratio, 11.40) and the Moderna vaccine (RRR, 9.26). Similar findings were observed within 42 days after vaccination.
The observed-to-expected ratios were 3.79 for 21-day and 2.34 for 42-day intervals after receipt of the Janssen vaccine, and less than 1 (not significant) after the Pfizer or Moderna vaccine within both post-vaccination periods.
“Unlike prior studies, our analysis included all U.S. reports of verified GBS cases that met the Brighton Collaboration GBS case definition criteria (Brighton Levels 1, 2, and 3) submitted over a 14-month surveillance period to the to the Vaccine Adverse Event Reporting System,” Dr. Abara said in an interview. “Because we used all U.S. reports, the sample of verified GBS cases in this analysis is larger than other studies. Therefore, it may provide a more precise estimate of the GBS risk within 21 and 42 days after mRNA and Ad26.COV2.S vaccination,” he said.
‘Remarkably low’ use
Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, Calif., noted that this is a “nice confirmatory analysis that supports and further expands what’s been observed before.”
Last year, as reported by this news organization, Dr. Klein and colleagues reported data from the Vaccine Safety Datalink confirming a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Janssen COVID-19 vaccine but not the Pfizer or Moderna vaccines.
Unlike VAERS, the Vaccine Safety Datalink is not a reporting system. It’s an active surveillance of medical records in the Kaiser Permanente system. The VAERS is a passive system, so it requires individuals to report GBS cases to the VAERS team, Dr. Klein explained.
So although the two studies are slightly different, overall, the VAERS data is “consistent with what we found,” she said.
Also weighing in, C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and professor of pediatrics at the Vanderbilt University School of Medicine, Nashville, Tenn., said it is “important to realize that GBS had been observed after adenovirus-vectored vaccines earlier in the pandemic, both for the AstraZeneca vaccine and the Janssen vaccine.”
The Advisory Committee on Immunization Practices (ACIP) preferentially recommends that people age 18 years and older receive an mRNA COVID-19 vaccine rather than the Janssen adenoviral vector vaccine when both types of COVID-19 vaccine are available.
“Thus, the use of the Janssen vaccine is remarkably low in the U.S. right now,” Dr. Creech said.
“Nevertheless, we have a firm commitment, both scientifically and ethically, to track potential side effects after vaccination and to make sure that the vaccines in use for COVID, and other important infectious diseases, are safe and effective,” he added.
The study had no commercial funding. Dr. Abara and Dr. Creech have reported no relevant financial relationships. Dr. Klein reported having received grants from Pfizer research support for a COVID vaccine clinical trial, as well as grants from Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur).
A version of this article first appeared on Medscape.com.
Over 14 months, GBS reporting rates within 21 and 42 days of administration of Janssen’s replication-incompetent adenoviral vector vaccine were approximately 9 to 12 times higher than after administration of the Pfizer-BioNTech (BNT162b2) or the Moderna (mRNA-1273) mRNA COVID vaccines.
Additionally, observed GBS cases after the Janssen shot were 2 to 3 times greater than expected, based on background rates within 21 and 42 days of vaccination.
Conversely, and confirming prior data, there was no increased risk for GBS with the Pfizer or Moderna vaccines and no significant difference between observed and expected numbers of GBS cases after either mRNA COVID-19 vaccine.
The findings were published online in JAMA Network Open.
More precise risk estimates
Winston Abara, MD, with the U.S. Centers for Disease Control and Prevention, and colleagues analyzed GBS reports submitted to the VAERS between December 2020 and January 2022.
Among 487.6 million COVID-19 vaccine doses administered, 3.7% were Janssen’s Ad26.COV2.S vaccine, 54.7% were Pfizer’s BNT162b2 vaccine, and 41.6% were Moderna’s mRNA-1273 vaccine.
There were 295 verified reports of GBS identified after COVID-19 vaccination. Of these, 209 occurred within 21 days of vaccination and 253 within 42 days.
Within 21 days of vaccination, GBS reporting rates per 1 million doses were 3.29 for the Janssen vaccine versus 0.29 and 0.35 for the Pfizer and Moderna vaccines, respectively. Within 42 days of vaccination, reporting rates per 1 million doses were 4.07, 0.34, and 0.44, respectively.
Also within 21 days of vaccination, GBS reporting rates were significantly higher with the Janssen vaccine than the Pfizer vaccine (reporting rate ratio, 11.40) and the Moderna vaccine (RRR, 9.26). Similar findings were observed within 42 days after vaccination.
The observed-to-expected ratios were 3.79 for 21-day and 2.34 for 42-day intervals after receipt of the Janssen vaccine, and less than 1 (not significant) after the Pfizer or Moderna vaccine within both post-vaccination periods.
“Unlike prior studies, our analysis included all U.S. reports of verified GBS cases that met the Brighton Collaboration GBS case definition criteria (Brighton Levels 1, 2, and 3) submitted over a 14-month surveillance period to the to the Vaccine Adverse Event Reporting System,” Dr. Abara said in an interview. “Because we used all U.S. reports, the sample of verified GBS cases in this analysis is larger than other studies. Therefore, it may provide a more precise estimate of the GBS risk within 21 and 42 days after mRNA and Ad26.COV2.S vaccination,” he said.
‘Remarkably low’ use
Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, Calif., noted that this is a “nice confirmatory analysis that supports and further expands what’s been observed before.”
Last year, as reported by this news organization, Dr. Klein and colleagues reported data from the Vaccine Safety Datalink confirming a small but statistically significant increased risk for GBS in the 3 weeks after receipt of the Janssen COVID-19 vaccine but not the Pfizer or Moderna vaccines.
Unlike VAERS, the Vaccine Safety Datalink is not a reporting system. It’s an active surveillance of medical records in the Kaiser Permanente system. The VAERS is a passive system, so it requires individuals to report GBS cases to the VAERS team, Dr. Klein explained.
So although the two studies are slightly different, overall, the VAERS data is “consistent with what we found,” she said.
Also weighing in, C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and professor of pediatrics at the Vanderbilt University School of Medicine, Nashville, Tenn., said it is “important to realize that GBS had been observed after adenovirus-vectored vaccines earlier in the pandemic, both for the AstraZeneca vaccine and the Janssen vaccine.”
The Advisory Committee on Immunization Practices (ACIP) preferentially recommends that people age 18 years and older receive an mRNA COVID-19 vaccine rather than the Janssen adenoviral vector vaccine when both types of COVID-19 vaccine are available.
“Thus, the use of the Janssen vaccine is remarkably low in the U.S. right now,” Dr. Creech said.
“Nevertheless, we have a firm commitment, both scientifically and ethically, to track potential side effects after vaccination and to make sure that the vaccines in use for COVID, and other important infectious diseases, are safe and effective,” he added.
The study had no commercial funding. Dr. Abara and Dr. Creech have reported no relevant financial relationships. Dr. Klein reported having received grants from Pfizer research support for a COVID vaccine clinical trial, as well as grants from Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur).
A version of this article first appeared on Medscape.com.
Genetic testing in the PICU prompts meaningful changes in care
according to a new study presented at the Society of Critical Care Medicine’s 2023 Critical Care Congress.
“We have had a lot of success using genome sequencing to help not only with diagnosis, but also changes in management,” lead author Katherine Rodriguez, MD, a pediatric critical care fellow physician at Rady Children’s Hospital, San Diego, told this news organization.
However, data on the use of rapid whole genome sequencing (rWGS) in the pediatric intensive care unit (PICU) are limited, and data from multiple institutions are lacking, Dr. Rodriguez said. In the current study, data from multiple hospitals allowed the researchers to examine differences in management across institutions, she said.
Dr. Rodriguez, with principal investigator Nicole Coufal, MD, also of Rady Children’s, and colleagues conducted the study at three children’s hospitals from March 2019 to July 2022. The study population included 80 children whose origin of illness was uncertain. The patients underwent rWGS testing in the PICU or cardiac ICU setting. The patients ranged in age from 0 to 17 years; 64% were younger than 1 year, (mean age, 2.8 years); 56% were male, and 59% were White.
After rWGS testing, 65% of the children were positive for a genetic variant. The data prompted changes to care for 42% of these patients; 38% of the changes occurred during the patient’s PICU stay, including medication changes and procedures that were either avoided or completed.
The remaining 62% of the changes were subacute and affected management for the remainder of the child’s hospitalization and after discharge, Dr. Rodriguez explained in her presentation.
The average turnaround time for the testing was 10 days, which is important to an intensivist, who may have been hesitant to order tests because of the time involved, Dr. Rodriguez said. The current study shows that “we can get test results in a reasonable time to make meaningful changes in care,” she told this news organization.
Choosing which patients to test can be a challenge for clinicians, Dr. Rodriguez acknowledged. “We have gotten a sense of which patients are likely to have diagnostic or not diagnostic genomes, but it is also a gut feeling,” she said.
“If this child is your patient and you are concerned, if they seem sicker than expected, or have a concerning family history, then send the test,” she said. “It is becoming more affordable, and can come back quickly enough to guide treatment while the patient is still in the ICU.”
In the current study, the greatest diagnostic utility appeared in patients with cardiac symptoms, such as congenital heart disease, sudden cardiac arrest, or suspected channelopathy, Dr. Rodriguez said in her presentation.
Patients with suspected neurological disease had a 50% rate of molecular diagnosis. “Interestingly, 74% of patients with respiratory disease where an underlying genetic etiology was suspected received a molecular diagnosis,” although rWGS was not applied to general populations with RSV or other respiratory illnesses, she said.
In her presentation, Dr. Rodriguez shared examples of how genetic testing had a dramatic impact on patient survival. In one case, a 14-year-old girl presented in cardiac arrest and was found to have new-onset dilated cardiomyopathy. Whether the etiology was acquired or infectious and possibly reversible or genetic was unclear, she said.
“A diagnostic genome result within 48 hours indicated a genetic etiology,” she said. The patient was listed for heart transplant despite the incomplete infectious workup, and received a successful heart transplant 1 week after admission, Dr. Rodriguez said.
Guidelines for which PICU patients should undergo genetic testing do not yet exist, Dr. Rodriguez told this news organization. “We are trying to find some more meaningful parameters where we can say that a patient has a high pretest possibility of a genetic condition,” she said.
“Increasing availability of rWGS can significantly impact patient care and assist families in making difficult decisions during times of critical illness,” she said.
Insurance coverage and testing access are improving, said Dr. Rodriguez. Medicaid policies exist for neonates/infants in the ICU in several states, including Oregon, California, Michigan, Maryland, and Louisiana, she said. In some areas, hospitals may pay for testing for these children if insurance will not, she added.
Dr. Rodriguez and colleagues are continuing to enroll patients in a prospective study of the impact of rWGS, with the addition of a fourth study site and inclusion of family surveys. “We also will be looking at a secondary analysis of cost savings and benefits,” she said.
Ultimately, the current study should be empowering to physicians, “especially if they don’t have good access to geneticists,” Dr. Rodriguez said in an interview.
The study received no outside funding. Dr. Rodriguez reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study presented at the Society of Critical Care Medicine’s 2023 Critical Care Congress.
“We have had a lot of success using genome sequencing to help not only with diagnosis, but also changes in management,” lead author Katherine Rodriguez, MD, a pediatric critical care fellow physician at Rady Children’s Hospital, San Diego, told this news organization.
However, data on the use of rapid whole genome sequencing (rWGS) in the pediatric intensive care unit (PICU) are limited, and data from multiple institutions are lacking, Dr. Rodriguez said. In the current study, data from multiple hospitals allowed the researchers to examine differences in management across institutions, she said.
Dr. Rodriguez, with principal investigator Nicole Coufal, MD, also of Rady Children’s, and colleagues conducted the study at three children’s hospitals from March 2019 to July 2022. The study population included 80 children whose origin of illness was uncertain. The patients underwent rWGS testing in the PICU or cardiac ICU setting. The patients ranged in age from 0 to 17 years; 64% were younger than 1 year, (mean age, 2.8 years); 56% were male, and 59% were White.
After rWGS testing, 65% of the children were positive for a genetic variant. The data prompted changes to care for 42% of these patients; 38% of the changes occurred during the patient’s PICU stay, including medication changes and procedures that were either avoided or completed.
The remaining 62% of the changes were subacute and affected management for the remainder of the child’s hospitalization and after discharge, Dr. Rodriguez explained in her presentation.
The average turnaround time for the testing was 10 days, which is important to an intensivist, who may have been hesitant to order tests because of the time involved, Dr. Rodriguez said. The current study shows that “we can get test results in a reasonable time to make meaningful changes in care,” she told this news organization.
Choosing which patients to test can be a challenge for clinicians, Dr. Rodriguez acknowledged. “We have gotten a sense of which patients are likely to have diagnostic or not diagnostic genomes, but it is also a gut feeling,” she said.
“If this child is your patient and you are concerned, if they seem sicker than expected, or have a concerning family history, then send the test,” she said. “It is becoming more affordable, and can come back quickly enough to guide treatment while the patient is still in the ICU.”
In the current study, the greatest diagnostic utility appeared in patients with cardiac symptoms, such as congenital heart disease, sudden cardiac arrest, or suspected channelopathy, Dr. Rodriguez said in her presentation.
Patients with suspected neurological disease had a 50% rate of molecular diagnosis. “Interestingly, 74% of patients with respiratory disease where an underlying genetic etiology was suspected received a molecular diagnosis,” although rWGS was not applied to general populations with RSV or other respiratory illnesses, she said.
In her presentation, Dr. Rodriguez shared examples of how genetic testing had a dramatic impact on patient survival. In one case, a 14-year-old girl presented in cardiac arrest and was found to have new-onset dilated cardiomyopathy. Whether the etiology was acquired or infectious and possibly reversible or genetic was unclear, she said.
“A diagnostic genome result within 48 hours indicated a genetic etiology,” she said. The patient was listed for heart transplant despite the incomplete infectious workup, and received a successful heart transplant 1 week after admission, Dr. Rodriguez said.
Guidelines for which PICU patients should undergo genetic testing do not yet exist, Dr. Rodriguez told this news organization. “We are trying to find some more meaningful parameters where we can say that a patient has a high pretest possibility of a genetic condition,” she said.
“Increasing availability of rWGS can significantly impact patient care and assist families in making difficult decisions during times of critical illness,” she said.
Insurance coverage and testing access are improving, said Dr. Rodriguez. Medicaid policies exist for neonates/infants in the ICU in several states, including Oregon, California, Michigan, Maryland, and Louisiana, she said. In some areas, hospitals may pay for testing for these children if insurance will not, she added.
Dr. Rodriguez and colleagues are continuing to enroll patients in a prospective study of the impact of rWGS, with the addition of a fourth study site and inclusion of family surveys. “We also will be looking at a secondary analysis of cost savings and benefits,” she said.
Ultimately, the current study should be empowering to physicians, “especially if they don’t have good access to geneticists,” Dr. Rodriguez said in an interview.
The study received no outside funding. Dr. Rodriguez reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study presented at the Society of Critical Care Medicine’s 2023 Critical Care Congress.
“We have had a lot of success using genome sequencing to help not only with diagnosis, but also changes in management,” lead author Katherine Rodriguez, MD, a pediatric critical care fellow physician at Rady Children’s Hospital, San Diego, told this news organization.
However, data on the use of rapid whole genome sequencing (rWGS) in the pediatric intensive care unit (PICU) are limited, and data from multiple institutions are lacking, Dr. Rodriguez said. In the current study, data from multiple hospitals allowed the researchers to examine differences in management across institutions, she said.
Dr. Rodriguez, with principal investigator Nicole Coufal, MD, also of Rady Children’s, and colleagues conducted the study at three children’s hospitals from March 2019 to July 2022. The study population included 80 children whose origin of illness was uncertain. The patients underwent rWGS testing in the PICU or cardiac ICU setting. The patients ranged in age from 0 to 17 years; 64% were younger than 1 year, (mean age, 2.8 years); 56% were male, and 59% were White.
After rWGS testing, 65% of the children were positive for a genetic variant. The data prompted changes to care for 42% of these patients; 38% of the changes occurred during the patient’s PICU stay, including medication changes and procedures that were either avoided or completed.
The remaining 62% of the changes were subacute and affected management for the remainder of the child’s hospitalization and after discharge, Dr. Rodriguez explained in her presentation.
The average turnaround time for the testing was 10 days, which is important to an intensivist, who may have been hesitant to order tests because of the time involved, Dr. Rodriguez said. The current study shows that “we can get test results in a reasonable time to make meaningful changes in care,” she told this news organization.
Choosing which patients to test can be a challenge for clinicians, Dr. Rodriguez acknowledged. “We have gotten a sense of which patients are likely to have diagnostic or not diagnostic genomes, but it is also a gut feeling,” she said.
“If this child is your patient and you are concerned, if they seem sicker than expected, or have a concerning family history, then send the test,” she said. “It is becoming more affordable, and can come back quickly enough to guide treatment while the patient is still in the ICU.”
In the current study, the greatest diagnostic utility appeared in patients with cardiac symptoms, such as congenital heart disease, sudden cardiac arrest, or suspected channelopathy, Dr. Rodriguez said in her presentation.
Patients with suspected neurological disease had a 50% rate of molecular diagnosis. “Interestingly, 74% of patients with respiratory disease where an underlying genetic etiology was suspected received a molecular diagnosis,” although rWGS was not applied to general populations with RSV or other respiratory illnesses, she said.
In her presentation, Dr. Rodriguez shared examples of how genetic testing had a dramatic impact on patient survival. In one case, a 14-year-old girl presented in cardiac arrest and was found to have new-onset dilated cardiomyopathy. Whether the etiology was acquired or infectious and possibly reversible or genetic was unclear, she said.
“A diagnostic genome result within 48 hours indicated a genetic etiology,” she said. The patient was listed for heart transplant despite the incomplete infectious workup, and received a successful heart transplant 1 week after admission, Dr. Rodriguez said.
Guidelines for which PICU patients should undergo genetic testing do not yet exist, Dr. Rodriguez told this news organization. “We are trying to find some more meaningful parameters where we can say that a patient has a high pretest possibility of a genetic condition,” she said.
“Increasing availability of rWGS can significantly impact patient care and assist families in making difficult decisions during times of critical illness,” she said.
Insurance coverage and testing access are improving, said Dr. Rodriguez. Medicaid policies exist for neonates/infants in the ICU in several states, including Oregon, California, Michigan, Maryland, and Louisiana, she said. In some areas, hospitals may pay for testing for these children if insurance will not, she added.
Dr. Rodriguez and colleagues are continuing to enroll patients in a prospective study of the impact of rWGS, with the addition of a fourth study site and inclusion of family surveys. “We also will be looking at a secondary analysis of cost savings and benefits,” she said.
Ultimately, the current study should be empowering to physicians, “especially if they don’t have good access to geneticists,” Dr. Rodriguez said in an interview.
The study received no outside funding. Dr. Rodriguez reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM SCCM 2023
Quality of life predicts chemo tolerance in early breast cancer
a new analysis found.
Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”
The findings were published online in the journal Cancer.
Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.
To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.
The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.
Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.
Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.
After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.
In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.
The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.
“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.
This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
A version of this article first appeared on Medscape.com.
a new analysis found.
Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”
The findings were published online in the journal Cancer.
Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.
To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.
The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.
Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.
Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.
After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.
In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.
The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.
“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.
This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
A version of this article first appeared on Medscape.com.
a new analysis found.
Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”
The findings were published online in the journal Cancer.
Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.
To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.
The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.
Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.
Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.
After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.
In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.
The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.
“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.
This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER