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Fibroids: Is surgery the only management approach?
Two chronic gynecologic conditions notably affect a woman’s quality of life (QoL), including fertility – one is endometriosis, and the other is a fibroid uterus. For a benign tumor, fibroids have an impressive prevalence found in approximately 50%-60% of women during their reproductive years. By menopause, it is estimated that 70% of woman have a fibroid, yet the true incidence is unknown given that only 25% of women experience symptoms bothersome enough to warrant intervention. This month’s article reviews the burden of fibroids and the latest management options that may potentially avoid surgery.
Background
Fibroids are monoclonal tumors of uterine smooth muscle that originate from the myometrium. Risk factors include family history, being premenopausal, increasing time since last delivery, obesity, and hypertension (ACOG Practice Bulletin no. 228 Jun 2021: Obstet Gynecol. 2021 Jun 1;137[6]:e100-e15) but oral hormonal contraception, depot medroxyprogesterone acetate (MPA), and increased parity reduce the risk of fibroids. Compared with White women, Black women have a 2-3 times higher prevalence of fibroids, develop them at a younger age, and present with larger fibroids.
The FIGO leiomyoma classification is the agreed upon system for identifying fibroid location. Symptoms are all too familiar to gynecologists, with life-threatening hemorrhage with severe anemia being the most feared, particularly for FIGO types 1-5. Transvaginal ultrasound is the simplest imaging tool for evaluation.
Fibroids and fertility
Fibroids can impair fertility in several ways: alteration of local anatomy, including the detrimental effects of abnormal uterine bleeding; functional changes by increasing uterine contractions and impairing endometrium and myometrial blood supply; and changes to the local hormonal environment that could impair egg/sperm transport, or embryo implantation (Hum Reprod Update. 2017;22:665-86).
Prior to consideration of surgery, saline infusion sonogram can determine the degree of impact on the endometrium, which is most applicable to the infertility patient, but can also allow guidance toward the appropriate surgical approach.
Treatment options – medical
Management of fibroids is based on a woman’s age, desire for fertility, symptoms, and location of the fibroid(s). Expectant observation of a woman with fibroids may be a reasonable approach, provided the lack of symptoms impairing QoL and of anemia. Typically, there is no change in fibroid size during the short term, considered less than 1 year. Regarding fertility, studies are heterogeneous so there is no definitive conclusion that fibroids impair natural fertility (Reprod Biomed Online. 2021;43:100-10). Spontaneous regression, defined by a reduction in fibroid volume of greater than 20%, has been noted to occur in 7.0% of fibroids (Curr Obstet Gynecol Rep. 2018;7[3]:117-21).
When fertility is not desired, medical management of fibroids is the initial conservative approach. GnRH agonists have been utilized for temporary relief of menometrorrhagia because of fibroids and to reduce their volume, particularly preoperatively. However, extended treatment can induce bone mineral density loss. Add-back therapy (tibolone, raloxifene, estriol, and ipriflavone) is of value in reducing bone loss while MPA and tibolone may manage vasomotor symptoms. More recently, the use of a GnRH antagonist (elagolix) along with add-back therapy has been approved for up to 24 months by the Food and Drug Administration and has demonstrated a more than 50% amenorrhea rate at 12 months (Obstet Gynecol. 2020;135:1313-26).
Progesterone plays an important role in fibroid growth, but the mechanism is unclear. Although not FDA approved, selective progesterone receptor modulators (SPRM) act directly on fibroid size reduction at the level of the pituitary to induce amenorrhea through inhibition of ovulation. Also, more than one course of SPRMs can provide benefit for bleeding control and volume reduction. The SPRM ulipristal acetate for four courses of 3 months demonstrated 73.5% of patients experienced a fibroid volume reduction of greater than 25% and were amenorrheic (Fertil Steril. 2017;108:416-25). GnRH agonists or SPRMs may benefit women if the fibroid is larger than 3 cm or anemia exists, thereby precluding immediate surgery.
Other medication options include the levonorgestrel IUD, combined hormonal contraceptives, and tranexamic acid – all of which have limited data on effective results of treating abnormal uterine bleeding.
Treatment options – surgical
Fibroids are the most common reason for hysterectomy as they are the contributing indication in approximately one-third of surgeries. When future fertility is desired, current surgical options include hysteroscopic and laparoscopic (including robotic) myomectomy. Hysteroscopy is the standard approach for FIGO type 1 fibroids and can also manage some type 2 fibroids provided they are less than 3 cm and the latter is greater than 5 mm from the serosa. Type 2 fibroids may benefit from a “two-step” removal to allow the myometrium to contract and extrude the fibroid. In light of the risk of fluid overload with nonelectrolyte solutions that enable the use of monopolar cautery, many procedures are now performed with bipolar cautery or morcellators.
Laparoscopy (including robotic) has outcomes similar to those of laparotomy although the risk of uterine rupture with the former requires careful attention to thorough closure of the myometrial defect. Robotic myomectomy has outcomes similar to those of standard laparoscopy with less blood loss, but operating times may be prolonged (Best Pract Res Clin Obstet Gynaecol. 2018;46:113-9).
The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women (Fertil Steril 2017;108;416-25). The rate of recurrence after myomectomy can be as great as 60% when patients are followed up to 5 years. Intramural fibroids greater than 2.85 cm and not distorting the uterine cavity may decrease in vitro fertilization (IVF) success (Fertil Steril 2014;101:716-21).
Noninvasive treatment modalities
Uterine artery embolization (UAE) is the most popular minimally invasive alternative to surgical myomectomy. Risks include postembolization syndrome (pain, fever, nausea, leukocytosis, and occasionally malaise), infection, and damage to fertility. Rarely, loss of ovarian function can occur, particularly in women above age 45. Because of the disruption of uterine blood flow, UAE increases the risk of accelerating ovarian aging and infertility as well as atrophic endometrium. In addition, pregnancy complications are increased including miscarriage, preterm labor, and postpartum hemorrhage. There is debate regarding the need for cesarean section at time of delivery given the potential for weakening of the uterine wall following UAE.
High-intensity focused ultrasound (HIFU) is guided by ultrasound or MRI and involves a high-energy-density ultrasound wave passing through the skin. The wave is absorbed and transformed into heat, causing the tissue protein to coagulate, and to be absorbed by the body. The procedure is scarless, carries a minimal risk of infection, and offers less pain compared with traditional approaches. However, HIFU is time consuming, and skin burns and unintentional tissue injury are a risk. A meta-analysis demonstrated improved symptoms of fibroids at 6 and 12 months (J Min Invasive Gynecol. 2021 in press).
Ultrasound-guided microwave ablation (MWA) uses an ablative electrode that is directly inserted into the target tissue via transcutaneous or transcervical approach via ultrasound guidance using microwave to produce heat for tissue coagulation necrosis. The advantages of MWA compared with HIFU and RFA are a higher tissue temperature, larger ablation volume, shorter operating time, less pain and no adverse major events (J Min Invasive Gynecol. 2021, in press).
Conclusion
The current literature cannot conclude that fibroids reduce the likelihood of achieving pregnancy with or without fertility treatment, based on a specific size, number, or location (not including submucosal or cavity-distorting intramural fibroids). Definitive evidence on the efficacy of myomectomy to improve fertility remains limited. Hysteroscopic myomectomy presumably improves pregnancy rates, but there is uncertainty as to its role in reducing miscarriage. Novel nonsurgical modalities are available and are expected to continue being developed but clarity on fertility outcomes is needed.
Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no conflicts of interests. Please contact him at obnews@mdedge.com.
Two chronic gynecologic conditions notably affect a woman’s quality of life (QoL), including fertility – one is endometriosis, and the other is a fibroid uterus. For a benign tumor, fibroids have an impressive prevalence found in approximately 50%-60% of women during their reproductive years. By menopause, it is estimated that 70% of woman have a fibroid, yet the true incidence is unknown given that only 25% of women experience symptoms bothersome enough to warrant intervention. This month’s article reviews the burden of fibroids and the latest management options that may potentially avoid surgery.
Background
Fibroids are monoclonal tumors of uterine smooth muscle that originate from the myometrium. Risk factors include family history, being premenopausal, increasing time since last delivery, obesity, and hypertension (ACOG Practice Bulletin no. 228 Jun 2021: Obstet Gynecol. 2021 Jun 1;137[6]:e100-e15) but oral hormonal contraception, depot medroxyprogesterone acetate (MPA), and increased parity reduce the risk of fibroids. Compared with White women, Black women have a 2-3 times higher prevalence of fibroids, develop them at a younger age, and present with larger fibroids.
The FIGO leiomyoma classification is the agreed upon system for identifying fibroid location. Symptoms are all too familiar to gynecologists, with life-threatening hemorrhage with severe anemia being the most feared, particularly for FIGO types 1-5. Transvaginal ultrasound is the simplest imaging tool for evaluation.
Fibroids and fertility
Fibroids can impair fertility in several ways: alteration of local anatomy, including the detrimental effects of abnormal uterine bleeding; functional changes by increasing uterine contractions and impairing endometrium and myometrial blood supply; and changes to the local hormonal environment that could impair egg/sperm transport, or embryo implantation (Hum Reprod Update. 2017;22:665-86).
Prior to consideration of surgery, saline infusion sonogram can determine the degree of impact on the endometrium, which is most applicable to the infertility patient, but can also allow guidance toward the appropriate surgical approach.
Treatment options – medical
Management of fibroids is based on a woman’s age, desire for fertility, symptoms, and location of the fibroid(s). Expectant observation of a woman with fibroids may be a reasonable approach, provided the lack of symptoms impairing QoL and of anemia. Typically, there is no change in fibroid size during the short term, considered less than 1 year. Regarding fertility, studies are heterogeneous so there is no definitive conclusion that fibroids impair natural fertility (Reprod Biomed Online. 2021;43:100-10). Spontaneous regression, defined by a reduction in fibroid volume of greater than 20%, has been noted to occur in 7.0% of fibroids (Curr Obstet Gynecol Rep. 2018;7[3]:117-21).
When fertility is not desired, medical management of fibroids is the initial conservative approach. GnRH agonists have been utilized for temporary relief of menometrorrhagia because of fibroids and to reduce their volume, particularly preoperatively. However, extended treatment can induce bone mineral density loss. Add-back therapy (tibolone, raloxifene, estriol, and ipriflavone) is of value in reducing bone loss while MPA and tibolone may manage vasomotor symptoms. More recently, the use of a GnRH antagonist (elagolix) along with add-back therapy has been approved for up to 24 months by the Food and Drug Administration and has demonstrated a more than 50% amenorrhea rate at 12 months (Obstet Gynecol. 2020;135:1313-26).
Progesterone plays an important role in fibroid growth, but the mechanism is unclear. Although not FDA approved, selective progesterone receptor modulators (SPRM) act directly on fibroid size reduction at the level of the pituitary to induce amenorrhea through inhibition of ovulation. Also, more than one course of SPRMs can provide benefit for bleeding control and volume reduction. The SPRM ulipristal acetate for four courses of 3 months demonstrated 73.5% of patients experienced a fibroid volume reduction of greater than 25% and were amenorrheic (Fertil Steril. 2017;108:416-25). GnRH agonists or SPRMs may benefit women if the fibroid is larger than 3 cm or anemia exists, thereby precluding immediate surgery.
Other medication options include the levonorgestrel IUD, combined hormonal contraceptives, and tranexamic acid – all of which have limited data on effective results of treating abnormal uterine bleeding.
Treatment options – surgical
Fibroids are the most common reason for hysterectomy as they are the contributing indication in approximately one-third of surgeries. When future fertility is desired, current surgical options include hysteroscopic and laparoscopic (including robotic) myomectomy. Hysteroscopy is the standard approach for FIGO type 1 fibroids and can also manage some type 2 fibroids provided they are less than 3 cm and the latter is greater than 5 mm from the serosa. Type 2 fibroids may benefit from a “two-step” removal to allow the myometrium to contract and extrude the fibroid. In light of the risk of fluid overload with nonelectrolyte solutions that enable the use of monopolar cautery, many procedures are now performed with bipolar cautery or morcellators.
Laparoscopy (including robotic) has outcomes similar to those of laparotomy although the risk of uterine rupture with the former requires careful attention to thorough closure of the myometrial defect. Robotic myomectomy has outcomes similar to those of standard laparoscopy with less blood loss, but operating times may be prolonged (Best Pract Res Clin Obstet Gynaecol. 2018;46:113-9).
The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women (Fertil Steril 2017;108;416-25). The rate of recurrence after myomectomy can be as great as 60% when patients are followed up to 5 years. Intramural fibroids greater than 2.85 cm and not distorting the uterine cavity may decrease in vitro fertilization (IVF) success (Fertil Steril 2014;101:716-21).
Noninvasive treatment modalities
Uterine artery embolization (UAE) is the most popular minimally invasive alternative to surgical myomectomy. Risks include postembolization syndrome (pain, fever, nausea, leukocytosis, and occasionally malaise), infection, and damage to fertility. Rarely, loss of ovarian function can occur, particularly in women above age 45. Because of the disruption of uterine blood flow, UAE increases the risk of accelerating ovarian aging and infertility as well as atrophic endometrium. In addition, pregnancy complications are increased including miscarriage, preterm labor, and postpartum hemorrhage. There is debate regarding the need for cesarean section at time of delivery given the potential for weakening of the uterine wall following UAE.
High-intensity focused ultrasound (HIFU) is guided by ultrasound or MRI and involves a high-energy-density ultrasound wave passing through the skin. The wave is absorbed and transformed into heat, causing the tissue protein to coagulate, and to be absorbed by the body. The procedure is scarless, carries a minimal risk of infection, and offers less pain compared with traditional approaches. However, HIFU is time consuming, and skin burns and unintentional tissue injury are a risk. A meta-analysis demonstrated improved symptoms of fibroids at 6 and 12 months (J Min Invasive Gynecol. 2021 in press).
Ultrasound-guided microwave ablation (MWA) uses an ablative electrode that is directly inserted into the target tissue via transcutaneous or transcervical approach via ultrasound guidance using microwave to produce heat for tissue coagulation necrosis. The advantages of MWA compared with HIFU and RFA are a higher tissue temperature, larger ablation volume, shorter operating time, less pain and no adverse major events (J Min Invasive Gynecol. 2021, in press).
Conclusion
The current literature cannot conclude that fibroids reduce the likelihood of achieving pregnancy with or without fertility treatment, based on a specific size, number, or location (not including submucosal or cavity-distorting intramural fibroids). Definitive evidence on the efficacy of myomectomy to improve fertility remains limited. Hysteroscopic myomectomy presumably improves pregnancy rates, but there is uncertainty as to its role in reducing miscarriage. Novel nonsurgical modalities are available and are expected to continue being developed but clarity on fertility outcomes is needed.
Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no conflicts of interests. Please contact him at obnews@mdedge.com.
Two chronic gynecologic conditions notably affect a woman’s quality of life (QoL), including fertility – one is endometriosis, and the other is a fibroid uterus. For a benign tumor, fibroids have an impressive prevalence found in approximately 50%-60% of women during their reproductive years. By menopause, it is estimated that 70% of woman have a fibroid, yet the true incidence is unknown given that only 25% of women experience symptoms bothersome enough to warrant intervention. This month’s article reviews the burden of fibroids and the latest management options that may potentially avoid surgery.
Background
Fibroids are monoclonal tumors of uterine smooth muscle that originate from the myometrium. Risk factors include family history, being premenopausal, increasing time since last delivery, obesity, and hypertension (ACOG Practice Bulletin no. 228 Jun 2021: Obstet Gynecol. 2021 Jun 1;137[6]:e100-e15) but oral hormonal contraception, depot medroxyprogesterone acetate (MPA), and increased parity reduce the risk of fibroids. Compared with White women, Black women have a 2-3 times higher prevalence of fibroids, develop them at a younger age, and present with larger fibroids.
The FIGO leiomyoma classification is the agreed upon system for identifying fibroid location. Symptoms are all too familiar to gynecologists, with life-threatening hemorrhage with severe anemia being the most feared, particularly for FIGO types 1-5. Transvaginal ultrasound is the simplest imaging tool for evaluation.
Fibroids and fertility
Fibroids can impair fertility in several ways: alteration of local anatomy, including the detrimental effects of abnormal uterine bleeding; functional changes by increasing uterine contractions and impairing endometrium and myometrial blood supply; and changes to the local hormonal environment that could impair egg/sperm transport, or embryo implantation (Hum Reprod Update. 2017;22:665-86).
Prior to consideration of surgery, saline infusion sonogram can determine the degree of impact on the endometrium, which is most applicable to the infertility patient, but can also allow guidance toward the appropriate surgical approach.
Treatment options – medical
Management of fibroids is based on a woman’s age, desire for fertility, symptoms, and location of the fibroid(s). Expectant observation of a woman with fibroids may be a reasonable approach, provided the lack of symptoms impairing QoL and of anemia. Typically, there is no change in fibroid size during the short term, considered less than 1 year. Regarding fertility, studies are heterogeneous so there is no definitive conclusion that fibroids impair natural fertility (Reprod Biomed Online. 2021;43:100-10). Spontaneous regression, defined by a reduction in fibroid volume of greater than 20%, has been noted to occur in 7.0% of fibroids (Curr Obstet Gynecol Rep. 2018;7[3]:117-21).
When fertility is not desired, medical management of fibroids is the initial conservative approach. GnRH agonists have been utilized for temporary relief of menometrorrhagia because of fibroids and to reduce their volume, particularly preoperatively. However, extended treatment can induce bone mineral density loss. Add-back therapy (tibolone, raloxifene, estriol, and ipriflavone) is of value in reducing bone loss while MPA and tibolone may manage vasomotor symptoms. More recently, the use of a GnRH antagonist (elagolix) along with add-back therapy has been approved for up to 24 months by the Food and Drug Administration and has demonstrated a more than 50% amenorrhea rate at 12 months (Obstet Gynecol. 2020;135:1313-26).
Progesterone plays an important role in fibroid growth, but the mechanism is unclear. Although not FDA approved, selective progesterone receptor modulators (SPRM) act directly on fibroid size reduction at the level of the pituitary to induce amenorrhea through inhibition of ovulation. Also, more than one course of SPRMs can provide benefit for bleeding control and volume reduction. The SPRM ulipristal acetate for four courses of 3 months demonstrated 73.5% of patients experienced a fibroid volume reduction of greater than 25% and were amenorrheic (Fertil Steril. 2017;108:416-25). GnRH agonists or SPRMs may benefit women if the fibroid is larger than 3 cm or anemia exists, thereby precluding immediate surgery.
Other medication options include the levonorgestrel IUD, combined hormonal contraceptives, and tranexamic acid – all of which have limited data on effective results of treating abnormal uterine bleeding.
Treatment options – surgical
Fibroids are the most common reason for hysterectomy as they are the contributing indication in approximately one-third of surgeries. When future fertility is desired, current surgical options include hysteroscopic and laparoscopic (including robotic) myomectomy. Hysteroscopy is the standard approach for FIGO type 1 fibroids and can also manage some type 2 fibroids provided they are less than 3 cm and the latter is greater than 5 mm from the serosa. Type 2 fibroids may benefit from a “two-step” removal to allow the myometrium to contract and extrude the fibroid. In light of the risk of fluid overload with nonelectrolyte solutions that enable the use of monopolar cautery, many procedures are now performed with bipolar cautery or morcellators.
Laparoscopy (including robotic) has outcomes similar to those of laparotomy although the risk of uterine rupture with the former requires careful attention to thorough closure of the myometrial defect. Robotic myomectomy has outcomes similar to those of standard laparoscopy with less blood loss, but operating times may be prolonged (Best Pract Res Clin Obstet Gynaecol. 2018;46:113-9).
The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women (Fertil Steril 2017;108;416-25). The rate of recurrence after myomectomy can be as great as 60% when patients are followed up to 5 years. Intramural fibroids greater than 2.85 cm and not distorting the uterine cavity may decrease in vitro fertilization (IVF) success (Fertil Steril 2014;101:716-21).
Noninvasive treatment modalities
Uterine artery embolization (UAE) is the most popular minimally invasive alternative to surgical myomectomy. Risks include postembolization syndrome (pain, fever, nausea, leukocytosis, and occasionally malaise), infection, and damage to fertility. Rarely, loss of ovarian function can occur, particularly in women above age 45. Because of the disruption of uterine blood flow, UAE increases the risk of accelerating ovarian aging and infertility as well as atrophic endometrium. In addition, pregnancy complications are increased including miscarriage, preterm labor, and postpartum hemorrhage. There is debate regarding the need for cesarean section at time of delivery given the potential for weakening of the uterine wall following UAE.
High-intensity focused ultrasound (HIFU) is guided by ultrasound or MRI and involves a high-energy-density ultrasound wave passing through the skin. The wave is absorbed and transformed into heat, causing the tissue protein to coagulate, and to be absorbed by the body. The procedure is scarless, carries a minimal risk of infection, and offers less pain compared with traditional approaches. However, HIFU is time consuming, and skin burns and unintentional tissue injury are a risk. A meta-analysis demonstrated improved symptoms of fibroids at 6 and 12 months (J Min Invasive Gynecol. 2021 in press).
Ultrasound-guided microwave ablation (MWA) uses an ablative electrode that is directly inserted into the target tissue via transcutaneous or transcervical approach via ultrasound guidance using microwave to produce heat for tissue coagulation necrosis. The advantages of MWA compared with HIFU and RFA are a higher tissue temperature, larger ablation volume, shorter operating time, less pain and no adverse major events (J Min Invasive Gynecol. 2021, in press).
Conclusion
The current literature cannot conclude that fibroids reduce the likelihood of achieving pregnancy with or without fertility treatment, based on a specific size, number, or location (not including submucosal or cavity-distorting intramural fibroids). Definitive evidence on the efficacy of myomectomy to improve fertility remains limited. Hysteroscopic myomectomy presumably improves pregnancy rates, but there is uncertainty as to its role in reducing miscarriage. Novel nonsurgical modalities are available and are expected to continue being developed but clarity on fertility outcomes is needed.
Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no conflicts of interests. Please contact him at obnews@mdedge.com.
Grandmothers, the Friendship Bench, and wisdom
Is this model a blueprint for delivering mental health care?
The 4-year-old boy and his grandmother are out for stroll around the neighborhood, walking hand in hand.
“Let’s sit on the bench and talk,” the boy says.
“Okay,” says the grandmother and they climb up onto the high bench and look out across the quiet road to a small garden beyond.
“What would you like to talk about?” his grandmother asks.
“You first,” he says.
“Okay, let’s see ... the grandmother and the grandson are out for a walk and they see a bench to sit on. They climb up and look around. They see the daffodils and the white clouds in the blue sky. The breeze is blowing gently. It is a happy day. Your turn; what would you like to talk about?”
“Nanna and Papa.”
“Do you miss Papa?”
“Yes.”
“It has been a whole year since he died.”
“A long, long time.”
“He loved you very much.”
“Yes,” the boy replies.
“Nanna must miss him very much. She must be lonely without him.”
The boy nods.
They sit on for a while, watching the occasional car and the occasional bird pass by. The boy and the grandmother are quiet and contemplative.
“Okay, let’s go,” he says and jumps down, ready to continue their walk.
The Friendship Bench
It must have been such an experience that gave Dixon Chibanda, MD, MPH, PhD, a psychiatrist from Zimbabwe, his brilliant idea. He trained grandmothers in evidence-based talk therapy and sat them on a bench in the park with his patients.1,2 He founded the Friendship Bench in 2006 in the Harare township of Mbare with 14 grandmothers. There are more than 300 grandmothers sitting on benches, listening, and providing cognitive-behavioral therapy–informed interventions because he could find no therapists in the community and he found that, with a little training, these grandmothers could provide effective culturally sensitive interventions.
Originally, the sessions were conducted in Shona, the predominant native language in Zimbabwe, but since 2017, the sessions are also in English. By 2017, the Friendship Bench had helped more than 30,000 people. The method has been empirically vetted and expanded to countries beyond, including the United States. Dr. Chibanda’s Friendship Bench serves as a blueprint for any community interested in bringing affordable, accessible, and highly effective mental health services to its residents. Dr. Chibanda said: “Imagine if we could create a global network of grandmothers in every major city in the world.”3 Participants in this study reported that the Friendship Bench had a critical role in helping them accept their HIV status, citing the grandmothers’ empathic attitude, their normalization of the reality of living with HIV, and their encouragement of young people to socialize with peers and be free of guilt. Many recipients also described enhanced health and well-being.
Why grandmothers?
Have you heard of the evolutionary importance of grandmothers? The grandmother hypothesis is an adaptationist explanation for the fact that the human female lifespan extends beyond the period of fertility. A third of the average human female life span is post menopause. Does such a long female postreproductive life span have a reason, inquired Mwenza Blell, PhD.5
Peter B. Medawar, PhD,6 and Kristen Hawkes, PhD,7 suggested that grandparents influence their own fitness by their actions toward their grandchildren. International fieldwork has revealed that the situation is less clear than their hypothesis. In industrialized countries, grandmaternal support is often financial or emotional. Two meta-analyses of largely the same group of studies investigating grandmother effects have come up with differing conclusions. Rebecca Sear, PhD, and Ruth Mace, PhD, conclude that grandmothers are “almost universally” beneficial, while acknowledging some variation in the effects of paternal grandmothers.8 Maternal grandparents appear to invest more in their grandchildren than paternal grandparents. Beverly I. Strassmann, PhD, and Wendy M. Garrard, PhD, concluded that, in patrilineal societies, survival of maternal grandparents is associated with survival of grandchildren and suggest this may represent covert matriliny.9
Examining specific time periods, maternal grandmothers may have greatest effect on survival of grandchildren at the time of weaning, a time when increased pathogenic exposure is a threat to survival. Paternal grandmothers may influence the survival of grandchildren during the early period of life (1-12 months) and to influence the condition of their daughters-in-law during pregnancy. The fact that grandmothers share one X chromosome with their sons’ daughters, none with their sons’ sons, and have a 50% chance of sharing an X chromosome with their daughters’ children is suggested to explain the patterns of survival observed in these studies than a simple maternal/paternal division.
In low- and middle-income countries, grandmothers and older women are seen as owners of traditional knowledge, and influence many decisions about childcare, help with domestic work, and emotional support and advice.10 Studies find a significant positive impact on breastfeeding when grandmothers of the infants had their own breastfeeding experience or were positively inclined toward breastfeeding, although one Chinese study found that highly educated grandmothers were associated with decreased exclusive breastfeeding.11 Despite this, most health programs target individual new mothers, without an understanding of the family and who else influences decisions.
Grandchildren and grandparents benefit from intergenerational activities with improved health and well-being of both generations. When older adults are involved in raising children, there is a significant reduction in the incidence of behavioral problems in childhood and adolescence. Grandparents improve grandchild outcomes, when measured by coresidence, caregiving, financial, and other support. The grandchild outcomes include physical health, socioemotional well-being, and cognitive development.12
Are there ‘grandparent genes?’
Flavio Schwarz, PhD, and colleagues think that variants of APOE and CD33 protect against heart disease and Alzheimer’s disease, allowing older people to live longer with better functioning hearts and brains – thus enabling transfer of wisdom from older to younger generations.13 While this logic may be a bit of a stretch, it does lead to a more interesting question: What has wisdom got to do with it?
When I ask psychiatrists what they think about wisdom, they give a variety of answers. Dilip Jeste, MD, a geriatric psychiatrist who studies successful aging, helped develop a measurable vision of wisdom.14 Wisdom is defined as a “multidimensional human trait that includes good social decision-making and pragmatic knowledge of life, prosocial attitudes and behaviors such as empathy and compassion, emotional homeostasis with a tendency to favor positive emotions, reflection and self-understanding, acknowledgment of and coping effectively with uncertainty, and decisiveness.”15 Others suggest that they include spirituality, openness to new experience, and a sense of humor.16 A scale called the San Diego Wisdom scale (SD-WISE) was created, using 524 community-dwelling adults aged 25-104 years. These subjects comprised a high proportion of White adults and individuals with a higher education, thus lacking diversity. Lack of diversity perpetuates generalizations, and like all sociocultural constructs, truth is specific to the population studied. High scores on the SD-WISE are positively correlated with good mental health, self-ratings of successful aging, mastery, resilience, happiness, and satisfaction with life.
Which brings us back to the grandmothers on the bench: Can someone please give them the SD-WISE scale and confirm several hypotheses? I would like to know whether a pragmatic knowledge of life is a recognized grandmotherly quality, suitable for the bench.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest.
References
1. Chibanda D. Bull World Health Organ. 2018 Jun 196(6):376-7.
2. Cavanaugh R. Lancet Psychiatry. 2017 Nov. doi: 10.1016/S2215-0366(17)30420-0.
3. Nuwer R. “How a bench and a team of grandmothers can tackle depression.” BBC. 2020 May 27.
4. Ouansafi I et al. PLoS One. 2021 Apr 22;16(4):e0250074.
5. Blell M. “Grandmother hypothesis, grandmother effect, and residence patterns.” Int Encyclopedia Anthropol. John Wiley & Sons, 2018.
6. Medawar PB. An Unsolved Problem of Biology. Routledge, 1957.
7. Hawkes K et al. Proc Nat Acad Sci. 1998 Feb 395(3):1336-9.
8. Sear R and Mace R. Evol Hum Behav. 2008;29(1):1-18.
9. Strassmann B and Garrard WM. Hum Nat. 2011 Jul;22(1-2):201-22.
10. Aubel J. BMJ Glob Health. 2021;6(2). doi 10.1136/bmjgh-2020-003808.
11. Negin J et al. BMJ Pregnancy Childbirth. 2016 Apr 7. doi: 10.1186/s12884-016-0880-5.
12. Sadruddin AFA. Soc Sci Med. 2019 Aug;239(4):112476.
13. Schwarz F et al. Proc Nat Acad Sci. 2016 Jan 5;113(1):74-9.
14. Jeste DV et al. Psychol Inquiry. 2020 Jun 22;31(2):134-43.
15. Meeks TW and Jeste DV. Arch Gen Psychiatry. 2009 Apr;66(4):355-65.
16. Bangen KJ et al. Am J Geriatr Psychiatry. 2013 Dec;21(12):1254-66.
Is this model a blueprint for delivering mental health care?
Is this model a blueprint for delivering mental health care?
The 4-year-old boy and his grandmother are out for stroll around the neighborhood, walking hand in hand.
“Let’s sit on the bench and talk,” the boy says.
“Okay,” says the grandmother and they climb up onto the high bench and look out across the quiet road to a small garden beyond.
“What would you like to talk about?” his grandmother asks.
“You first,” he says.
“Okay, let’s see ... the grandmother and the grandson are out for a walk and they see a bench to sit on. They climb up and look around. They see the daffodils and the white clouds in the blue sky. The breeze is blowing gently. It is a happy day. Your turn; what would you like to talk about?”
“Nanna and Papa.”
“Do you miss Papa?”
“Yes.”
“It has been a whole year since he died.”
“A long, long time.”
“He loved you very much.”
“Yes,” the boy replies.
“Nanna must miss him very much. She must be lonely without him.”
The boy nods.
They sit on for a while, watching the occasional car and the occasional bird pass by. The boy and the grandmother are quiet and contemplative.
“Okay, let’s go,” he says and jumps down, ready to continue their walk.
The Friendship Bench
It must have been such an experience that gave Dixon Chibanda, MD, MPH, PhD, a psychiatrist from Zimbabwe, his brilliant idea. He trained grandmothers in evidence-based talk therapy and sat them on a bench in the park with his patients.1,2 He founded the Friendship Bench in 2006 in the Harare township of Mbare with 14 grandmothers. There are more than 300 grandmothers sitting on benches, listening, and providing cognitive-behavioral therapy–informed interventions because he could find no therapists in the community and he found that, with a little training, these grandmothers could provide effective culturally sensitive interventions.
Originally, the sessions were conducted in Shona, the predominant native language in Zimbabwe, but since 2017, the sessions are also in English. By 2017, the Friendship Bench had helped more than 30,000 people. The method has been empirically vetted and expanded to countries beyond, including the United States. Dr. Chibanda’s Friendship Bench serves as a blueprint for any community interested in bringing affordable, accessible, and highly effective mental health services to its residents. Dr. Chibanda said: “Imagine if we could create a global network of grandmothers in every major city in the world.”3 Participants in this study reported that the Friendship Bench had a critical role in helping them accept their HIV status, citing the grandmothers’ empathic attitude, their normalization of the reality of living with HIV, and their encouragement of young people to socialize with peers and be free of guilt. Many recipients also described enhanced health and well-being.
Why grandmothers?
Have you heard of the evolutionary importance of grandmothers? The grandmother hypothesis is an adaptationist explanation for the fact that the human female lifespan extends beyond the period of fertility. A third of the average human female life span is post menopause. Does such a long female postreproductive life span have a reason, inquired Mwenza Blell, PhD.5
Peter B. Medawar, PhD,6 and Kristen Hawkes, PhD,7 suggested that grandparents influence their own fitness by their actions toward their grandchildren. International fieldwork has revealed that the situation is less clear than their hypothesis. In industrialized countries, grandmaternal support is often financial or emotional. Two meta-analyses of largely the same group of studies investigating grandmother effects have come up with differing conclusions. Rebecca Sear, PhD, and Ruth Mace, PhD, conclude that grandmothers are “almost universally” beneficial, while acknowledging some variation in the effects of paternal grandmothers.8 Maternal grandparents appear to invest more in their grandchildren than paternal grandparents. Beverly I. Strassmann, PhD, and Wendy M. Garrard, PhD, concluded that, in patrilineal societies, survival of maternal grandparents is associated with survival of grandchildren and suggest this may represent covert matriliny.9
Examining specific time periods, maternal grandmothers may have greatest effect on survival of grandchildren at the time of weaning, a time when increased pathogenic exposure is a threat to survival. Paternal grandmothers may influence the survival of grandchildren during the early period of life (1-12 months) and to influence the condition of their daughters-in-law during pregnancy. The fact that grandmothers share one X chromosome with their sons’ daughters, none with their sons’ sons, and have a 50% chance of sharing an X chromosome with their daughters’ children is suggested to explain the patterns of survival observed in these studies than a simple maternal/paternal division.
In low- and middle-income countries, grandmothers and older women are seen as owners of traditional knowledge, and influence many decisions about childcare, help with domestic work, and emotional support and advice.10 Studies find a significant positive impact on breastfeeding when grandmothers of the infants had their own breastfeeding experience or were positively inclined toward breastfeeding, although one Chinese study found that highly educated grandmothers were associated with decreased exclusive breastfeeding.11 Despite this, most health programs target individual new mothers, without an understanding of the family and who else influences decisions.
Grandchildren and grandparents benefit from intergenerational activities with improved health and well-being of both generations. When older adults are involved in raising children, there is a significant reduction in the incidence of behavioral problems in childhood and adolescence. Grandparents improve grandchild outcomes, when measured by coresidence, caregiving, financial, and other support. The grandchild outcomes include physical health, socioemotional well-being, and cognitive development.12
Are there ‘grandparent genes?’
Flavio Schwarz, PhD, and colleagues think that variants of APOE and CD33 protect against heart disease and Alzheimer’s disease, allowing older people to live longer with better functioning hearts and brains – thus enabling transfer of wisdom from older to younger generations.13 While this logic may be a bit of a stretch, it does lead to a more interesting question: What has wisdom got to do with it?
When I ask psychiatrists what they think about wisdom, they give a variety of answers. Dilip Jeste, MD, a geriatric psychiatrist who studies successful aging, helped develop a measurable vision of wisdom.14 Wisdom is defined as a “multidimensional human trait that includes good social decision-making and pragmatic knowledge of life, prosocial attitudes and behaviors such as empathy and compassion, emotional homeostasis with a tendency to favor positive emotions, reflection and self-understanding, acknowledgment of and coping effectively with uncertainty, and decisiveness.”15 Others suggest that they include spirituality, openness to new experience, and a sense of humor.16 A scale called the San Diego Wisdom scale (SD-WISE) was created, using 524 community-dwelling adults aged 25-104 years. These subjects comprised a high proportion of White adults and individuals with a higher education, thus lacking diversity. Lack of diversity perpetuates generalizations, and like all sociocultural constructs, truth is specific to the population studied. High scores on the SD-WISE are positively correlated with good mental health, self-ratings of successful aging, mastery, resilience, happiness, and satisfaction with life.
Which brings us back to the grandmothers on the bench: Can someone please give them the SD-WISE scale and confirm several hypotheses? I would like to know whether a pragmatic knowledge of life is a recognized grandmotherly quality, suitable for the bench.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest.
References
1. Chibanda D. Bull World Health Organ. 2018 Jun 196(6):376-7.
2. Cavanaugh R. Lancet Psychiatry. 2017 Nov. doi: 10.1016/S2215-0366(17)30420-0.
3. Nuwer R. “How a bench and a team of grandmothers can tackle depression.” BBC. 2020 May 27.
4. Ouansafi I et al. PLoS One. 2021 Apr 22;16(4):e0250074.
5. Blell M. “Grandmother hypothesis, grandmother effect, and residence patterns.” Int Encyclopedia Anthropol. John Wiley & Sons, 2018.
6. Medawar PB. An Unsolved Problem of Biology. Routledge, 1957.
7. Hawkes K et al. Proc Nat Acad Sci. 1998 Feb 395(3):1336-9.
8. Sear R and Mace R. Evol Hum Behav. 2008;29(1):1-18.
9. Strassmann B and Garrard WM. Hum Nat. 2011 Jul;22(1-2):201-22.
10. Aubel J. BMJ Glob Health. 2021;6(2). doi 10.1136/bmjgh-2020-003808.
11. Negin J et al. BMJ Pregnancy Childbirth. 2016 Apr 7. doi: 10.1186/s12884-016-0880-5.
12. Sadruddin AFA. Soc Sci Med. 2019 Aug;239(4):112476.
13. Schwarz F et al. Proc Nat Acad Sci. 2016 Jan 5;113(1):74-9.
14. Jeste DV et al. Psychol Inquiry. 2020 Jun 22;31(2):134-43.
15. Meeks TW and Jeste DV. Arch Gen Psychiatry. 2009 Apr;66(4):355-65.
16. Bangen KJ et al. Am J Geriatr Psychiatry. 2013 Dec;21(12):1254-66.
The 4-year-old boy and his grandmother are out for stroll around the neighborhood, walking hand in hand.
“Let’s sit on the bench and talk,” the boy says.
“Okay,” says the grandmother and they climb up onto the high bench and look out across the quiet road to a small garden beyond.
“What would you like to talk about?” his grandmother asks.
“You first,” he says.
“Okay, let’s see ... the grandmother and the grandson are out for a walk and they see a bench to sit on. They climb up and look around. They see the daffodils and the white clouds in the blue sky. The breeze is blowing gently. It is a happy day. Your turn; what would you like to talk about?”
“Nanna and Papa.”
“Do you miss Papa?”
“Yes.”
“It has been a whole year since he died.”
“A long, long time.”
“He loved you very much.”
“Yes,” the boy replies.
“Nanna must miss him very much. She must be lonely without him.”
The boy nods.
They sit on for a while, watching the occasional car and the occasional bird pass by. The boy and the grandmother are quiet and contemplative.
“Okay, let’s go,” he says and jumps down, ready to continue their walk.
The Friendship Bench
It must have been such an experience that gave Dixon Chibanda, MD, MPH, PhD, a psychiatrist from Zimbabwe, his brilliant idea. He trained grandmothers in evidence-based talk therapy and sat them on a bench in the park with his patients.1,2 He founded the Friendship Bench in 2006 in the Harare township of Mbare with 14 grandmothers. There are more than 300 grandmothers sitting on benches, listening, and providing cognitive-behavioral therapy–informed interventions because he could find no therapists in the community and he found that, with a little training, these grandmothers could provide effective culturally sensitive interventions.
Originally, the sessions were conducted in Shona, the predominant native language in Zimbabwe, but since 2017, the sessions are also in English. By 2017, the Friendship Bench had helped more than 30,000 people. The method has been empirically vetted and expanded to countries beyond, including the United States. Dr. Chibanda’s Friendship Bench serves as a blueprint for any community interested in bringing affordable, accessible, and highly effective mental health services to its residents. Dr. Chibanda said: “Imagine if we could create a global network of grandmothers in every major city in the world.”3 Participants in this study reported that the Friendship Bench had a critical role in helping them accept their HIV status, citing the grandmothers’ empathic attitude, their normalization of the reality of living with HIV, and their encouragement of young people to socialize with peers and be free of guilt. Many recipients also described enhanced health and well-being.
Why grandmothers?
Have you heard of the evolutionary importance of grandmothers? The grandmother hypothesis is an adaptationist explanation for the fact that the human female lifespan extends beyond the period of fertility. A third of the average human female life span is post menopause. Does such a long female postreproductive life span have a reason, inquired Mwenza Blell, PhD.5
Peter B. Medawar, PhD,6 and Kristen Hawkes, PhD,7 suggested that grandparents influence their own fitness by their actions toward their grandchildren. International fieldwork has revealed that the situation is less clear than their hypothesis. In industrialized countries, grandmaternal support is often financial or emotional. Two meta-analyses of largely the same group of studies investigating grandmother effects have come up with differing conclusions. Rebecca Sear, PhD, and Ruth Mace, PhD, conclude that grandmothers are “almost universally” beneficial, while acknowledging some variation in the effects of paternal grandmothers.8 Maternal grandparents appear to invest more in their grandchildren than paternal grandparents. Beverly I. Strassmann, PhD, and Wendy M. Garrard, PhD, concluded that, in patrilineal societies, survival of maternal grandparents is associated with survival of grandchildren and suggest this may represent covert matriliny.9
Examining specific time periods, maternal grandmothers may have greatest effect on survival of grandchildren at the time of weaning, a time when increased pathogenic exposure is a threat to survival. Paternal grandmothers may influence the survival of grandchildren during the early period of life (1-12 months) and to influence the condition of their daughters-in-law during pregnancy. The fact that grandmothers share one X chromosome with their sons’ daughters, none with their sons’ sons, and have a 50% chance of sharing an X chromosome with their daughters’ children is suggested to explain the patterns of survival observed in these studies than a simple maternal/paternal division.
In low- and middle-income countries, grandmothers and older women are seen as owners of traditional knowledge, and influence many decisions about childcare, help with domestic work, and emotional support and advice.10 Studies find a significant positive impact on breastfeeding when grandmothers of the infants had their own breastfeeding experience or were positively inclined toward breastfeeding, although one Chinese study found that highly educated grandmothers were associated with decreased exclusive breastfeeding.11 Despite this, most health programs target individual new mothers, without an understanding of the family and who else influences decisions.
Grandchildren and grandparents benefit from intergenerational activities with improved health and well-being of both generations. When older adults are involved in raising children, there is a significant reduction in the incidence of behavioral problems in childhood and adolescence. Grandparents improve grandchild outcomes, when measured by coresidence, caregiving, financial, and other support. The grandchild outcomes include physical health, socioemotional well-being, and cognitive development.12
Are there ‘grandparent genes?’
Flavio Schwarz, PhD, and colleagues think that variants of APOE and CD33 protect against heart disease and Alzheimer’s disease, allowing older people to live longer with better functioning hearts and brains – thus enabling transfer of wisdom from older to younger generations.13 While this logic may be a bit of a stretch, it does lead to a more interesting question: What has wisdom got to do with it?
When I ask psychiatrists what they think about wisdom, they give a variety of answers. Dilip Jeste, MD, a geriatric psychiatrist who studies successful aging, helped develop a measurable vision of wisdom.14 Wisdom is defined as a “multidimensional human trait that includes good social decision-making and pragmatic knowledge of life, prosocial attitudes and behaviors such as empathy and compassion, emotional homeostasis with a tendency to favor positive emotions, reflection and self-understanding, acknowledgment of and coping effectively with uncertainty, and decisiveness.”15 Others suggest that they include spirituality, openness to new experience, and a sense of humor.16 A scale called the San Diego Wisdom scale (SD-WISE) was created, using 524 community-dwelling adults aged 25-104 years. These subjects comprised a high proportion of White adults and individuals with a higher education, thus lacking diversity. Lack of diversity perpetuates generalizations, and like all sociocultural constructs, truth is specific to the population studied. High scores on the SD-WISE are positively correlated with good mental health, self-ratings of successful aging, mastery, resilience, happiness, and satisfaction with life.
Which brings us back to the grandmothers on the bench: Can someone please give them the SD-WISE scale and confirm several hypotheses? I would like to know whether a pragmatic knowledge of life is a recognized grandmotherly quality, suitable for the bench.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest.
References
1. Chibanda D. Bull World Health Organ. 2018 Jun 196(6):376-7.
2. Cavanaugh R. Lancet Psychiatry. 2017 Nov. doi: 10.1016/S2215-0366(17)30420-0.
3. Nuwer R. “How a bench and a team of grandmothers can tackle depression.” BBC. 2020 May 27.
4. Ouansafi I et al. PLoS One. 2021 Apr 22;16(4):e0250074.
5. Blell M. “Grandmother hypothesis, grandmother effect, and residence patterns.” Int Encyclopedia Anthropol. John Wiley & Sons, 2018.
6. Medawar PB. An Unsolved Problem of Biology. Routledge, 1957.
7. Hawkes K et al. Proc Nat Acad Sci. 1998 Feb 395(3):1336-9.
8. Sear R and Mace R. Evol Hum Behav. 2008;29(1):1-18.
9. Strassmann B and Garrard WM. Hum Nat. 2011 Jul;22(1-2):201-22.
10. Aubel J. BMJ Glob Health. 2021;6(2). doi 10.1136/bmjgh-2020-003808.
11. Negin J et al. BMJ Pregnancy Childbirth. 2016 Apr 7. doi: 10.1186/s12884-016-0880-5.
12. Sadruddin AFA. Soc Sci Med. 2019 Aug;239(4):112476.
13. Schwarz F et al. Proc Nat Acad Sci. 2016 Jan 5;113(1):74-9.
14. Jeste DV et al. Psychol Inquiry. 2020 Jun 22;31(2):134-43.
15. Meeks TW and Jeste DV. Arch Gen Psychiatry. 2009 Apr;66(4):355-65.
16. Bangen KJ et al. Am J Geriatr Psychiatry. 2013 Dec;21(12):1254-66.
Animal-assisted therapy could boost patients’ mental health
For me, vacation planning brings with it a bit of anxiety and stress – particularly as we navigate the many uncertainties around COVID-19.
Not only must my husband and I think about our own safety, we also have to make sure that our beloved dog, Samson, gets the proper care while we are away.
My husband adopted Samson, an 11-year-old mixed-breed rescue, when he was just a year old. He’s an important part of our family.
So, when booking our hotel room and flights, we also had to find someone we trust to care for Samson in our absence. Family members are not always an option, so we often rely on pet-sitting apps. We looked through profile after profile, contacted sitters, and interrogated them as if we were looking for care for a tiny human.
Eventually, we found a service that allows owners to use a mobile app that provides updates about how their pets are faring. While we were away, the sitter sent daily photos and videos of Samson that put our minds at ease.
As a registered nurse who works in an ICU, my own anxiety about leaving Samson reminded me about my patients’ reservations about leaving their pets during hospitalizations. Many of them share the same kinds of anxieties when they are separated from their beloved pets. Hospital visits are rarely planned. I have cared for patients who expressed concerns about their pets being home alone and needing to coordinate pet care. In some cases – to alleviate those patients’ anxieties – I have helped them contact friends and family members to assist with care.
Pets’ popularity grows in U.S.
According to the 2019-2020 National Pet Owners Survey, about 67% of U.S. households own a pet – which translates to about 84.9 million homes. During the height of COVID, Americans also acquired a greater number of smaller pets.1 In addition, when social restrictions increased, the demand for dog adoptions and the desire to serve as foster owners rose significantly.2 Last Chance Animal Rescue of Waldorf, Md., reportedly saw the adoption of dogs rise from 30%-40% in 2020. Another animal rescue operation, Lucky Dog, of Arlington, Va., in 2020 helped about 3,385 pets find adoption, up from about 1,800 in 2019.3 About two-thirds of all American households and roughly half of elderly individuals own pets.4
I am not surprised by those numbers. In my nursing practice, I face many stress-related factors, such as alternating day and night shifts, 12-hour shifts, strenuous physical work, and the psychological strain of attending to ill and dying patients. Interacting with Samson helps relieve that stress. The motion of petting Samson helps calm my heart rate and decreases my anxiety. In addition, Samson makes me smile – and excites almost all the people I interact with while he’s around. Of course, I’m not objective, but I view Samson’s impact on people as a symbol of the power of animal-assisted therapy (AAT).
AAT, defined as “the positive interaction between an animal and a patient within a therapeutic framework,”has proven to be an effective intervention for adults with intellectual disabilities who experience anxiety in an observational study.5 The intervention also has helped reduce cortisol levels in a study of nurses in physical medicine, internal medicine, and long-term care.6 Since most patient hospital stays are unplanned, there is a need to introduce AAT into hospital care. This would lessen anxiety in patients concerning their pets’ welfare.
We know that long-term hospital stays often cause adverse psychosocial effects on patients. Such stays can result in “hospitalization syndrome,” which is characterized by a gradual loss of cognition and orientation, an unwillingness to maintain contact with others or to engage in group therapy, and a loss of interest in their surroundings.7 The common causes for this syndrome are infection, medication, isolation, response to surgery, and dehydration. A consequence can be a permanent change in cognitive function or psychological impairment. However, my experience of practicing nursing for years has led me to discover that pets as an external stimulus can prevent the syndrome’s onset. This is because a large percentage of hospitalized patients have pets, and contact with a pet reminds them of home and the memories they share at home.
Introducing animal therapy into health care facilities could boost patients’ mental health – and ease their anxiety – by acting as a bridge between their present circumstances and the lives they have outside the establishment.
References
1. American Pet Owners Association. Will the COVID Pet Spike Last? State of the industry presentation. 2021 Mar 24.
2. Morgan L et al. Humanit Soc Sci Comm. 2020 Nov 24;7(144). doi: 10.1057/S41599-020-00649-x.
3. Hedgpeth D. So many pets have been adopted during the pandemic that shelters are running out. Washington Post. 2021 Jan 6.
4. Cherniack EP and Cherniack AR. Curr Gerontol Geriatr Res. 2014. doi: 10.1155/2014/623203.
5. Giuliani F and Jacquemettaz M. Eur J Integ Med. 2017 Sep;14;13-9.
6. Machová K et al. Int J Environ Res and Public Health. 2019 Oct;16(19):3670.
7. Machová K et al. Int J Environ Res Public Health. 2012 Apr;16(8):1362.
Ms. Scott is a registered nurse specializing in critical care and also has experience in nursing leadership. She has 8 years of experience in cardiothoracic ICUs. Ms. Scott received a bachelor of science in nursing degree from Queens University of Charlotte (N.C.), and a master of business administration in health care administration from the University of North Alabama, Florence. She has no conflicts of interest.
For me, vacation planning brings with it a bit of anxiety and stress – particularly as we navigate the many uncertainties around COVID-19.
Not only must my husband and I think about our own safety, we also have to make sure that our beloved dog, Samson, gets the proper care while we are away.
My husband adopted Samson, an 11-year-old mixed-breed rescue, when he was just a year old. He’s an important part of our family.
So, when booking our hotel room and flights, we also had to find someone we trust to care for Samson in our absence. Family members are not always an option, so we often rely on pet-sitting apps. We looked through profile after profile, contacted sitters, and interrogated them as if we were looking for care for a tiny human.
Eventually, we found a service that allows owners to use a mobile app that provides updates about how their pets are faring. While we were away, the sitter sent daily photos and videos of Samson that put our minds at ease.
As a registered nurse who works in an ICU, my own anxiety about leaving Samson reminded me about my patients’ reservations about leaving their pets during hospitalizations. Many of them share the same kinds of anxieties when they are separated from their beloved pets. Hospital visits are rarely planned. I have cared for patients who expressed concerns about their pets being home alone and needing to coordinate pet care. In some cases – to alleviate those patients’ anxieties – I have helped them contact friends and family members to assist with care.
Pets’ popularity grows in U.S.
According to the 2019-2020 National Pet Owners Survey, about 67% of U.S. households own a pet – which translates to about 84.9 million homes. During the height of COVID, Americans also acquired a greater number of smaller pets.1 In addition, when social restrictions increased, the demand for dog adoptions and the desire to serve as foster owners rose significantly.2 Last Chance Animal Rescue of Waldorf, Md., reportedly saw the adoption of dogs rise from 30%-40% in 2020. Another animal rescue operation, Lucky Dog, of Arlington, Va., in 2020 helped about 3,385 pets find adoption, up from about 1,800 in 2019.3 About two-thirds of all American households and roughly half of elderly individuals own pets.4
I am not surprised by those numbers. In my nursing practice, I face many stress-related factors, such as alternating day and night shifts, 12-hour shifts, strenuous physical work, and the psychological strain of attending to ill and dying patients. Interacting with Samson helps relieve that stress. The motion of petting Samson helps calm my heart rate and decreases my anxiety. In addition, Samson makes me smile – and excites almost all the people I interact with while he’s around. Of course, I’m not objective, but I view Samson’s impact on people as a symbol of the power of animal-assisted therapy (AAT).
AAT, defined as “the positive interaction between an animal and a patient within a therapeutic framework,”has proven to be an effective intervention for adults with intellectual disabilities who experience anxiety in an observational study.5 The intervention also has helped reduce cortisol levels in a study of nurses in physical medicine, internal medicine, and long-term care.6 Since most patient hospital stays are unplanned, there is a need to introduce AAT into hospital care. This would lessen anxiety in patients concerning their pets’ welfare.
We know that long-term hospital stays often cause adverse psychosocial effects on patients. Such stays can result in “hospitalization syndrome,” which is characterized by a gradual loss of cognition and orientation, an unwillingness to maintain contact with others or to engage in group therapy, and a loss of interest in their surroundings.7 The common causes for this syndrome are infection, medication, isolation, response to surgery, and dehydration. A consequence can be a permanent change in cognitive function or psychological impairment. However, my experience of practicing nursing for years has led me to discover that pets as an external stimulus can prevent the syndrome’s onset. This is because a large percentage of hospitalized patients have pets, and contact with a pet reminds them of home and the memories they share at home.
Introducing animal therapy into health care facilities could boost patients’ mental health – and ease their anxiety – by acting as a bridge between their present circumstances and the lives they have outside the establishment.
References
1. American Pet Owners Association. Will the COVID Pet Spike Last? State of the industry presentation. 2021 Mar 24.
2. Morgan L et al. Humanit Soc Sci Comm. 2020 Nov 24;7(144). doi: 10.1057/S41599-020-00649-x.
3. Hedgpeth D. So many pets have been adopted during the pandemic that shelters are running out. Washington Post. 2021 Jan 6.
4. Cherniack EP and Cherniack AR. Curr Gerontol Geriatr Res. 2014. doi: 10.1155/2014/623203.
5. Giuliani F and Jacquemettaz M. Eur J Integ Med. 2017 Sep;14;13-9.
6. Machová K et al. Int J Environ Res and Public Health. 2019 Oct;16(19):3670.
7. Machová K et al. Int J Environ Res Public Health. 2012 Apr;16(8):1362.
Ms. Scott is a registered nurse specializing in critical care and also has experience in nursing leadership. She has 8 years of experience in cardiothoracic ICUs. Ms. Scott received a bachelor of science in nursing degree from Queens University of Charlotte (N.C.), and a master of business administration in health care administration from the University of North Alabama, Florence. She has no conflicts of interest.
For me, vacation planning brings with it a bit of anxiety and stress – particularly as we navigate the many uncertainties around COVID-19.
Not only must my husband and I think about our own safety, we also have to make sure that our beloved dog, Samson, gets the proper care while we are away.
My husband adopted Samson, an 11-year-old mixed-breed rescue, when he was just a year old. He’s an important part of our family.
So, when booking our hotel room and flights, we also had to find someone we trust to care for Samson in our absence. Family members are not always an option, so we often rely on pet-sitting apps. We looked through profile after profile, contacted sitters, and interrogated them as if we were looking for care for a tiny human.
Eventually, we found a service that allows owners to use a mobile app that provides updates about how their pets are faring. While we were away, the sitter sent daily photos and videos of Samson that put our minds at ease.
As a registered nurse who works in an ICU, my own anxiety about leaving Samson reminded me about my patients’ reservations about leaving their pets during hospitalizations. Many of them share the same kinds of anxieties when they are separated from their beloved pets. Hospital visits are rarely planned. I have cared for patients who expressed concerns about their pets being home alone and needing to coordinate pet care. In some cases – to alleviate those patients’ anxieties – I have helped them contact friends and family members to assist with care.
Pets’ popularity grows in U.S.
According to the 2019-2020 National Pet Owners Survey, about 67% of U.S. households own a pet – which translates to about 84.9 million homes. During the height of COVID, Americans also acquired a greater number of smaller pets.1 In addition, when social restrictions increased, the demand for dog adoptions and the desire to serve as foster owners rose significantly.2 Last Chance Animal Rescue of Waldorf, Md., reportedly saw the adoption of dogs rise from 30%-40% in 2020. Another animal rescue operation, Lucky Dog, of Arlington, Va., in 2020 helped about 3,385 pets find adoption, up from about 1,800 in 2019.3 About two-thirds of all American households and roughly half of elderly individuals own pets.4
I am not surprised by those numbers. In my nursing practice, I face many stress-related factors, such as alternating day and night shifts, 12-hour shifts, strenuous physical work, and the psychological strain of attending to ill and dying patients. Interacting with Samson helps relieve that stress. The motion of petting Samson helps calm my heart rate and decreases my anxiety. In addition, Samson makes me smile – and excites almost all the people I interact with while he’s around. Of course, I’m not objective, but I view Samson’s impact on people as a symbol of the power of animal-assisted therapy (AAT).
AAT, defined as “the positive interaction between an animal and a patient within a therapeutic framework,”has proven to be an effective intervention for adults with intellectual disabilities who experience anxiety in an observational study.5 The intervention also has helped reduce cortisol levels in a study of nurses in physical medicine, internal medicine, and long-term care.6 Since most patient hospital stays are unplanned, there is a need to introduce AAT into hospital care. This would lessen anxiety in patients concerning their pets’ welfare.
We know that long-term hospital stays often cause adverse psychosocial effects on patients. Such stays can result in “hospitalization syndrome,” which is characterized by a gradual loss of cognition and orientation, an unwillingness to maintain contact with others or to engage in group therapy, and a loss of interest in their surroundings.7 The common causes for this syndrome are infection, medication, isolation, response to surgery, and dehydration. A consequence can be a permanent change in cognitive function or psychological impairment. However, my experience of practicing nursing for years has led me to discover that pets as an external stimulus can prevent the syndrome’s onset. This is because a large percentage of hospitalized patients have pets, and contact with a pet reminds them of home and the memories they share at home.
Introducing animal therapy into health care facilities could boost patients’ mental health – and ease their anxiety – by acting as a bridge between their present circumstances and the lives they have outside the establishment.
References
1. American Pet Owners Association. Will the COVID Pet Spike Last? State of the industry presentation. 2021 Mar 24.
2. Morgan L et al. Humanit Soc Sci Comm. 2020 Nov 24;7(144). doi: 10.1057/S41599-020-00649-x.
3. Hedgpeth D. So many pets have been adopted during the pandemic that shelters are running out. Washington Post. 2021 Jan 6.
4. Cherniack EP and Cherniack AR. Curr Gerontol Geriatr Res. 2014. doi: 10.1155/2014/623203.
5. Giuliani F and Jacquemettaz M. Eur J Integ Med. 2017 Sep;14;13-9.
6. Machová K et al. Int J Environ Res and Public Health. 2019 Oct;16(19):3670.
7. Machová K et al. Int J Environ Res Public Health. 2012 Apr;16(8):1362.
Ms. Scott is a registered nurse specializing in critical care and also has experience in nursing leadership. She has 8 years of experience in cardiothoracic ICUs. Ms. Scott received a bachelor of science in nursing degree from Queens University of Charlotte (N.C.), and a master of business administration in health care administration from the University of North Alabama, Florence. She has no conflicts of interest.
Artificial intelligence wish list
Dear big-tech AI company,
I do understand, the benefits of artificial intelligence today are already profound and protean. Thanks to AI, I can translate Italian to English in real time in the same voice as an Italian speaker. I can be driven home autonomously by our Tesla. AI helps keep me safe by predicting crimes, on time by predicting traffic, and healthy by designing plant proteins that taste just like beef. I can even use AI to build a sprinkler to keep people off my new lawn.
In medicine, the AI news is so good that a frisson of excitement spreads vertically and horizontally across all health care. AI can detect pulmonary nodules, identify melanomas, develop new drugs – speed vaccine discovery! – and detect malignant cells on a biopsy slide. It can help predict who is going to crash in the ICU and recognize when someone is about to fall out of bed in the surgical unit. Even just this sampling of benefits proves how significant and impactful AI is in improving quality of life for patients and populations.
However, much of what I do every day in medicine cannot be solved with a neat quantitative analysis. The vast majority of my patients do not have a melanoma to be diagnosed or diabetic retinopathy to be scanned. What they want and need is time spent with me, their doctor. Although the schedule says I have 15 minutes (insufficient to begin with), patients are running late and are double booked, and I’ve loads of notes to type, medications to review, and messages to answer. Most days, I have only a fraction of 15 minutes to spend face to face with each patient.
Can AI please help us? How about reviewing the reams of data from my patient’s chart and presenting it to me succinctly? Rather than my tediously clicking through pathology reports, just summarize what skin cancers my patient has had and when. Rather than learning that my patient already failed Protopic a year ago, let me know that before I sign the order and promise: “Now, this ointment will work.” Even better, suggest alternative treatments that I might not be thinking of and which might do just the trick. Oh, and given my EMR has all the data required to determine billing codes, can you just drop that in for me when I’m done? Lastly, if the patient’s insurance is going to reject this claim or that medication, can AI please complete the authorization/paperwork/signed notary document/letter from U.S. senator that will be needed for it to be accepted?
I know this is possible. If we can blast a 70-year-old businessman into space on a private jet, surely you can invent an AI that gives us more time to spend with patients. Proposals postmarked by Dec. 31, 2021, please.
I’m sincerely yours,
Jeff Benabio, MD, MBA
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Dear big-tech AI company,
I do understand, the benefits of artificial intelligence today are already profound and protean. Thanks to AI, I can translate Italian to English in real time in the same voice as an Italian speaker. I can be driven home autonomously by our Tesla. AI helps keep me safe by predicting crimes, on time by predicting traffic, and healthy by designing plant proteins that taste just like beef. I can even use AI to build a sprinkler to keep people off my new lawn.
In medicine, the AI news is so good that a frisson of excitement spreads vertically and horizontally across all health care. AI can detect pulmonary nodules, identify melanomas, develop new drugs – speed vaccine discovery! – and detect malignant cells on a biopsy slide. It can help predict who is going to crash in the ICU and recognize when someone is about to fall out of bed in the surgical unit. Even just this sampling of benefits proves how significant and impactful AI is in improving quality of life for patients and populations.
However, much of what I do every day in medicine cannot be solved with a neat quantitative analysis. The vast majority of my patients do not have a melanoma to be diagnosed or diabetic retinopathy to be scanned. What they want and need is time spent with me, their doctor. Although the schedule says I have 15 minutes (insufficient to begin with), patients are running late and are double booked, and I’ve loads of notes to type, medications to review, and messages to answer. Most days, I have only a fraction of 15 minutes to spend face to face with each patient.
Can AI please help us? How about reviewing the reams of data from my patient’s chart and presenting it to me succinctly? Rather than my tediously clicking through pathology reports, just summarize what skin cancers my patient has had and when. Rather than learning that my patient already failed Protopic a year ago, let me know that before I sign the order and promise: “Now, this ointment will work.” Even better, suggest alternative treatments that I might not be thinking of and which might do just the trick. Oh, and given my EMR has all the data required to determine billing codes, can you just drop that in for me when I’m done? Lastly, if the patient’s insurance is going to reject this claim or that medication, can AI please complete the authorization/paperwork/signed notary document/letter from U.S. senator that will be needed for it to be accepted?
I know this is possible. If we can blast a 70-year-old businessman into space on a private jet, surely you can invent an AI that gives us more time to spend with patients. Proposals postmarked by Dec. 31, 2021, please.
I’m sincerely yours,
Jeff Benabio, MD, MBA
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Dear big-tech AI company,
I do understand, the benefits of artificial intelligence today are already profound and protean. Thanks to AI, I can translate Italian to English in real time in the same voice as an Italian speaker. I can be driven home autonomously by our Tesla. AI helps keep me safe by predicting crimes, on time by predicting traffic, and healthy by designing plant proteins that taste just like beef. I can even use AI to build a sprinkler to keep people off my new lawn.
In medicine, the AI news is so good that a frisson of excitement spreads vertically and horizontally across all health care. AI can detect pulmonary nodules, identify melanomas, develop new drugs – speed vaccine discovery! – and detect malignant cells on a biopsy slide. It can help predict who is going to crash in the ICU and recognize when someone is about to fall out of bed in the surgical unit. Even just this sampling of benefits proves how significant and impactful AI is in improving quality of life for patients and populations.
However, much of what I do every day in medicine cannot be solved with a neat quantitative analysis. The vast majority of my patients do not have a melanoma to be diagnosed or diabetic retinopathy to be scanned. What they want and need is time spent with me, their doctor. Although the schedule says I have 15 minutes (insufficient to begin with), patients are running late and are double booked, and I’ve loads of notes to type, medications to review, and messages to answer. Most days, I have only a fraction of 15 minutes to spend face to face with each patient.
Can AI please help us? How about reviewing the reams of data from my patient’s chart and presenting it to me succinctly? Rather than my tediously clicking through pathology reports, just summarize what skin cancers my patient has had and when. Rather than learning that my patient already failed Protopic a year ago, let me know that before I sign the order and promise: “Now, this ointment will work.” Even better, suggest alternative treatments that I might not be thinking of and which might do just the trick. Oh, and given my EMR has all the data required to determine billing codes, can you just drop that in for me when I’m done? Lastly, if the patient’s insurance is going to reject this claim or that medication, can AI please complete the authorization/paperwork/signed notary document/letter from U.S. senator that will be needed for it to be accepted?
I know this is possible. If we can blast a 70-year-old businessman into space on a private jet, surely you can invent an AI that gives us more time to spend with patients. Proposals postmarked by Dec. 31, 2021, please.
I’m sincerely yours,
Jeff Benabio, MD, MBA
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
The febrile infant: New AAP guidance for the first 2 months of life
Sixteen years in the making, the American Academy of Pediatrics just released a new clinical practice guideline (CPG), “Evaluation and Management of Well-Appearing Febrile Infants 8-60 Days Old”. The recommendations were derived from interpretations of sequential studies in young, febrile, but well-appearing infants that covered invasive bacterial infection (IBI) incidence, diagnostic modalities, and treatment during the first 2 months of life, further refining approaches to evaluation and empirical treatment.
Pediatricians have long had solid information to help assess the risk for IBI among febrile infants aged 0-3 months, but there has been an ongoing desire to further refine the suggested evaluation of these very young infants. A study of febrile infants from the Pediatric Research in Office Settings network along with subsequent evidence has identified the first 3 weeks of life as the period of highest risk for IBI, with risk declining in a graded fashion aged between 22 and 56 days.
Critical caveats
First, some caveats. Infants 0-7 days are not addressed in the CPG, and all should be treated as high risk and receive full IBI evaluation according to newborn protocols. Second, the recommendations apply only to “well-appearing” infants. Any ill-appearing infant should be treated as high risk and receive full IBI evaluation and begun on empirical antimicrobials. Third, even though the CPG deals with infants as young as 8-21 days old, the recommendations are to treat all infants in this age group as high risk, even if well-appearing, and complete full IBI evaluation and empirical therapy while awaiting results. Fourth, these guidelines apply only to infants born at 37 weeks’ gestation or more. Finally, the new CPG action statements are meant to be recommendations rather than a standard of medical care, leaving some leeway for clinician interpretation of individual patient scenarios. Where appropriate, parents’ values and preferences should be incorporated as part of shared decision-making.
The CPG divides young, febrile infants into three cohorts based on age:
- 8-21 days old
- 22-28 days old
- 29-60 days old
Age 8-21 days
For well-appearing febrile infants 8-21 days old, the CPG recommends a complete IBI evaluation that includes urine, blood, and cerebrospinal fluid (CSF) for culture, approaching all infants in this cohort as high risk. Inflammatory markers may be obtained, but the evidence is not comprehensive enough to evaluate their role in decision-making for this age group. A two-step urine evaluation method (urine analysis followed by culture if the urine analysis looks concerning) is not recommended for infants aged 8-21 days. Urine samples for culture from these young infants should be obtained by catheterization or suprapubic aspiration.
The CPG recommends drawing blood cultures and CSF by lumbar puncture from this cohort. These infants should be admitted to the hospital, treated empirically with antimicrobials, and actively monitored. However, if the cultures are negative at 24-36 hours, the clinician should discontinue antimicrobials and discharge the infant if there is no other reason for continued hospitalization.
Age 22-28 days
Well-appearing, febrile infants 22-28 days old are in an intermediate-risk zone. The recommendation for infants in this cohort is to obtain a urine specimen by catheterization or suprapubic aspiration for both urine analysis and culture. Clinicians may consider obtaining urine samples for analysis noninvasively (e.g., urine bag) in this cohort, but this is not the preferred method.
Blood culture should be obtained from all infants in this group. Inflammatory markers can help clinicians identify infants at greater risk for IBI, including meningitis. Previous data suggested that inflammatory markers such as serum white blood cell counts greater than 11,000/mcL, a serum absolute neutrophil count of greater than 4,000/mcL, and elevated C-reactive protein and procalcitonin levels could help providers identify febrile infants with true IBI. A 2008 study demonstrated that procalcitonin had the best receiver operating characteristic curve in regard to predicting IBI in young febrile infants. Other research backed up that finding and identified cutoff values for procalcitonin levels greater than 1.0 ng/mL. The CPG recommends considering a procalcitonin value of 0.5 ng/mL or higher as positive, indicating that the infant is at greater risk for IBI and potentially should undergo an expanded IBI workup. Therefore, in infants aged 22-28 days, inflammatory markers can play a role in deciding whether to perform a lumbar puncture.
Many more nuanced recommendations for whether to and how to empirically treat with antimicrobials in this cohort can be found in the CPG, including whether to manage in the hospital or at home. Treatment recommendations vary greatly for this cohort on the basis of the tests obtained and whether tests were positive or negative at the initial evaluation.
Age 29-60 days
The CPG will be most helpful when clinicians are faced with well-appearing, febrile infants in the 29- to 60-day age group. As with the other groups, a urine evaluation is recommended; however, the CPG suggests that the two-step approach – obtaining a urine analysis by a noninvasive method and only obtaining culture if the urine analysis is positive – is reasonable. This means that a bag or free-flowing urine specimen would be appropriate for urinalysis, followed by catheterization/suprapubic aspiration if a culture is necessary. This would save approximately 90% of infants from invasive urine collection. Regardless, only catheter or suprapubic specimens are appropriate for urine culture.
The CPG also recommends that clinicians obtain blood culture on all of these infants. Inflammatory markers should be assessed in this cohort because avoiding lumbar puncture for CSF culture would be appropriate in this cohort if the inflammatory markers are negative. If CSF is obtained in this age cohort, enterovirus testing should be added to the testing regimen. Again, for any infant considered at higher risk for IBI on the basis of screening tests, the CPG recommends a 24- to 36-hour rule-out period with empirical antimicrobial treatment and active monitoring in the hospital.
Summary
The recommended approach for febrile infants 8-21 days old is relatively aggressive, with urine, blood, and CSF evaluation for IBI. Clinicians gain some leeway for infants age 22-28 days, but the guidelines recommend a more flexible approach to evaluating well-appearing, febrile infants age 29-60 days, when a two-step urine evaluation and inflammatory marker assessment can help clinicians and parents have a better discussion about the risk-benefit trade-offs of more aggressive testing and empirical treatment.
The author would like to thank Ken Roberts, MD, for his review and helpful comments on this summary of the CPG highlights. Summary points of the CPG were presented by the writing group at the 2021 Pediatric Academic Societies meeting.
William T. Basco, Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.
A version of this article first appeared on Medscape.com.
Sixteen years in the making, the American Academy of Pediatrics just released a new clinical practice guideline (CPG), “Evaluation and Management of Well-Appearing Febrile Infants 8-60 Days Old”. The recommendations were derived from interpretations of sequential studies in young, febrile, but well-appearing infants that covered invasive bacterial infection (IBI) incidence, diagnostic modalities, and treatment during the first 2 months of life, further refining approaches to evaluation and empirical treatment.
Pediatricians have long had solid information to help assess the risk for IBI among febrile infants aged 0-3 months, but there has been an ongoing desire to further refine the suggested evaluation of these very young infants. A study of febrile infants from the Pediatric Research in Office Settings network along with subsequent evidence has identified the first 3 weeks of life as the period of highest risk for IBI, with risk declining in a graded fashion aged between 22 and 56 days.
Critical caveats
First, some caveats. Infants 0-7 days are not addressed in the CPG, and all should be treated as high risk and receive full IBI evaluation according to newborn protocols. Second, the recommendations apply only to “well-appearing” infants. Any ill-appearing infant should be treated as high risk and receive full IBI evaluation and begun on empirical antimicrobials. Third, even though the CPG deals with infants as young as 8-21 days old, the recommendations are to treat all infants in this age group as high risk, even if well-appearing, and complete full IBI evaluation and empirical therapy while awaiting results. Fourth, these guidelines apply only to infants born at 37 weeks’ gestation or more. Finally, the new CPG action statements are meant to be recommendations rather than a standard of medical care, leaving some leeway for clinician interpretation of individual patient scenarios. Where appropriate, parents’ values and preferences should be incorporated as part of shared decision-making.
The CPG divides young, febrile infants into three cohorts based on age:
- 8-21 days old
- 22-28 days old
- 29-60 days old
Age 8-21 days
For well-appearing febrile infants 8-21 days old, the CPG recommends a complete IBI evaluation that includes urine, blood, and cerebrospinal fluid (CSF) for culture, approaching all infants in this cohort as high risk. Inflammatory markers may be obtained, but the evidence is not comprehensive enough to evaluate their role in decision-making for this age group. A two-step urine evaluation method (urine analysis followed by culture if the urine analysis looks concerning) is not recommended for infants aged 8-21 days. Urine samples for culture from these young infants should be obtained by catheterization or suprapubic aspiration.
The CPG recommends drawing blood cultures and CSF by lumbar puncture from this cohort. These infants should be admitted to the hospital, treated empirically with antimicrobials, and actively monitored. However, if the cultures are negative at 24-36 hours, the clinician should discontinue antimicrobials and discharge the infant if there is no other reason for continued hospitalization.
Age 22-28 days
Well-appearing, febrile infants 22-28 days old are in an intermediate-risk zone. The recommendation for infants in this cohort is to obtain a urine specimen by catheterization or suprapubic aspiration for both urine analysis and culture. Clinicians may consider obtaining urine samples for analysis noninvasively (e.g., urine bag) in this cohort, but this is not the preferred method.
Blood culture should be obtained from all infants in this group. Inflammatory markers can help clinicians identify infants at greater risk for IBI, including meningitis. Previous data suggested that inflammatory markers such as serum white blood cell counts greater than 11,000/mcL, a serum absolute neutrophil count of greater than 4,000/mcL, and elevated C-reactive protein and procalcitonin levels could help providers identify febrile infants with true IBI. A 2008 study demonstrated that procalcitonin had the best receiver operating characteristic curve in regard to predicting IBI in young febrile infants. Other research backed up that finding and identified cutoff values for procalcitonin levels greater than 1.0 ng/mL. The CPG recommends considering a procalcitonin value of 0.5 ng/mL or higher as positive, indicating that the infant is at greater risk for IBI and potentially should undergo an expanded IBI workup. Therefore, in infants aged 22-28 days, inflammatory markers can play a role in deciding whether to perform a lumbar puncture.
Many more nuanced recommendations for whether to and how to empirically treat with antimicrobials in this cohort can be found in the CPG, including whether to manage in the hospital or at home. Treatment recommendations vary greatly for this cohort on the basis of the tests obtained and whether tests were positive or negative at the initial evaluation.
Age 29-60 days
The CPG will be most helpful when clinicians are faced with well-appearing, febrile infants in the 29- to 60-day age group. As with the other groups, a urine evaluation is recommended; however, the CPG suggests that the two-step approach – obtaining a urine analysis by a noninvasive method and only obtaining culture if the urine analysis is positive – is reasonable. This means that a bag or free-flowing urine specimen would be appropriate for urinalysis, followed by catheterization/suprapubic aspiration if a culture is necessary. This would save approximately 90% of infants from invasive urine collection. Regardless, only catheter or suprapubic specimens are appropriate for urine culture.
The CPG also recommends that clinicians obtain blood culture on all of these infants. Inflammatory markers should be assessed in this cohort because avoiding lumbar puncture for CSF culture would be appropriate in this cohort if the inflammatory markers are negative. If CSF is obtained in this age cohort, enterovirus testing should be added to the testing regimen. Again, for any infant considered at higher risk for IBI on the basis of screening tests, the CPG recommends a 24- to 36-hour rule-out period with empirical antimicrobial treatment and active monitoring in the hospital.
Summary
The recommended approach for febrile infants 8-21 days old is relatively aggressive, with urine, blood, and CSF evaluation for IBI. Clinicians gain some leeway for infants age 22-28 days, but the guidelines recommend a more flexible approach to evaluating well-appearing, febrile infants age 29-60 days, when a two-step urine evaluation and inflammatory marker assessment can help clinicians and parents have a better discussion about the risk-benefit trade-offs of more aggressive testing and empirical treatment.
The author would like to thank Ken Roberts, MD, for his review and helpful comments on this summary of the CPG highlights. Summary points of the CPG were presented by the writing group at the 2021 Pediatric Academic Societies meeting.
William T. Basco, Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.
A version of this article first appeared on Medscape.com.
Sixteen years in the making, the American Academy of Pediatrics just released a new clinical practice guideline (CPG), “Evaluation and Management of Well-Appearing Febrile Infants 8-60 Days Old”. The recommendations were derived from interpretations of sequential studies in young, febrile, but well-appearing infants that covered invasive bacterial infection (IBI) incidence, diagnostic modalities, and treatment during the first 2 months of life, further refining approaches to evaluation and empirical treatment.
Pediatricians have long had solid information to help assess the risk for IBI among febrile infants aged 0-3 months, but there has been an ongoing desire to further refine the suggested evaluation of these very young infants. A study of febrile infants from the Pediatric Research in Office Settings network along with subsequent evidence has identified the first 3 weeks of life as the period of highest risk for IBI, with risk declining in a graded fashion aged between 22 and 56 days.
Critical caveats
First, some caveats. Infants 0-7 days are not addressed in the CPG, and all should be treated as high risk and receive full IBI evaluation according to newborn protocols. Second, the recommendations apply only to “well-appearing” infants. Any ill-appearing infant should be treated as high risk and receive full IBI evaluation and begun on empirical antimicrobials. Third, even though the CPG deals with infants as young as 8-21 days old, the recommendations are to treat all infants in this age group as high risk, even if well-appearing, and complete full IBI evaluation and empirical therapy while awaiting results. Fourth, these guidelines apply only to infants born at 37 weeks’ gestation or more. Finally, the new CPG action statements are meant to be recommendations rather than a standard of medical care, leaving some leeway for clinician interpretation of individual patient scenarios. Where appropriate, parents’ values and preferences should be incorporated as part of shared decision-making.
The CPG divides young, febrile infants into three cohorts based on age:
- 8-21 days old
- 22-28 days old
- 29-60 days old
Age 8-21 days
For well-appearing febrile infants 8-21 days old, the CPG recommends a complete IBI evaluation that includes urine, blood, and cerebrospinal fluid (CSF) for culture, approaching all infants in this cohort as high risk. Inflammatory markers may be obtained, but the evidence is not comprehensive enough to evaluate their role in decision-making for this age group. A two-step urine evaluation method (urine analysis followed by culture if the urine analysis looks concerning) is not recommended for infants aged 8-21 days. Urine samples for culture from these young infants should be obtained by catheterization or suprapubic aspiration.
The CPG recommends drawing blood cultures and CSF by lumbar puncture from this cohort. These infants should be admitted to the hospital, treated empirically with antimicrobials, and actively monitored. However, if the cultures are negative at 24-36 hours, the clinician should discontinue antimicrobials and discharge the infant if there is no other reason for continued hospitalization.
Age 22-28 days
Well-appearing, febrile infants 22-28 days old are in an intermediate-risk zone. The recommendation for infants in this cohort is to obtain a urine specimen by catheterization or suprapubic aspiration for both urine analysis and culture. Clinicians may consider obtaining urine samples for analysis noninvasively (e.g., urine bag) in this cohort, but this is not the preferred method.
Blood culture should be obtained from all infants in this group. Inflammatory markers can help clinicians identify infants at greater risk for IBI, including meningitis. Previous data suggested that inflammatory markers such as serum white blood cell counts greater than 11,000/mcL, a serum absolute neutrophil count of greater than 4,000/mcL, and elevated C-reactive protein and procalcitonin levels could help providers identify febrile infants with true IBI. A 2008 study demonstrated that procalcitonin had the best receiver operating characteristic curve in regard to predicting IBI in young febrile infants. Other research backed up that finding and identified cutoff values for procalcitonin levels greater than 1.0 ng/mL. The CPG recommends considering a procalcitonin value of 0.5 ng/mL or higher as positive, indicating that the infant is at greater risk for IBI and potentially should undergo an expanded IBI workup. Therefore, in infants aged 22-28 days, inflammatory markers can play a role in deciding whether to perform a lumbar puncture.
Many more nuanced recommendations for whether to and how to empirically treat with antimicrobials in this cohort can be found in the CPG, including whether to manage in the hospital or at home. Treatment recommendations vary greatly for this cohort on the basis of the tests obtained and whether tests were positive or negative at the initial evaluation.
Age 29-60 days
The CPG will be most helpful when clinicians are faced with well-appearing, febrile infants in the 29- to 60-day age group. As with the other groups, a urine evaluation is recommended; however, the CPG suggests that the two-step approach – obtaining a urine analysis by a noninvasive method and only obtaining culture if the urine analysis is positive – is reasonable. This means that a bag or free-flowing urine specimen would be appropriate for urinalysis, followed by catheterization/suprapubic aspiration if a culture is necessary. This would save approximately 90% of infants from invasive urine collection. Regardless, only catheter or suprapubic specimens are appropriate for urine culture.
The CPG also recommends that clinicians obtain blood culture on all of these infants. Inflammatory markers should be assessed in this cohort because avoiding lumbar puncture for CSF culture would be appropriate in this cohort if the inflammatory markers are negative. If CSF is obtained in this age cohort, enterovirus testing should be added to the testing regimen. Again, for any infant considered at higher risk for IBI on the basis of screening tests, the CPG recommends a 24- to 36-hour rule-out period with empirical antimicrobial treatment and active monitoring in the hospital.
Summary
The recommended approach for febrile infants 8-21 days old is relatively aggressive, with urine, blood, and CSF evaluation for IBI. Clinicians gain some leeway for infants age 22-28 days, but the guidelines recommend a more flexible approach to evaluating well-appearing, febrile infants age 29-60 days, when a two-step urine evaluation and inflammatory marker assessment can help clinicians and parents have a better discussion about the risk-benefit trade-offs of more aggressive testing and empirical treatment.
The author would like to thank Ken Roberts, MD, for his review and helpful comments on this summary of the CPG highlights. Summary points of the CPG were presented by the writing group at the 2021 Pediatric Academic Societies meeting.
William T. Basco, Jr, MD, MS, is a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He is an active health services researcher and has published more than 60 manuscripts in the peer-reviewed literature.
A version of this article first appeared on Medscape.com.
The ADA and hearing-impaired patients
A recent claim against a New Jersey physician attracted considerable attention in both the medical and legal communities, not only because it resulted in a substantial jury award, but because that award was not covered by malpractice insurance.
It is a good reminder for the rest of us: This case involved a charge of discrimination against a hearing-impaired patient – which meant the physician not only had to fund his own defense, but was personally responsible for the $400,000 award against him.
The Americans with Disabilities Act (ADA) was designed to protect individuals with various disabilities against discrimination in various public situations – including, specifically, “the professional office of a health care professional.”
When the disability is impaired hearing, the law requires physicians to provide any “auxiliary aids and services” that might be necessary to insure clear communication between doctor and patient. In the vast majority of such situations, a pad and pencil will satisfy that requirement. But occasionally it does not, particularly when complex medical concepts are involved; and in such cases, as the New Jersey trial demonstrated, failure to make the necessary extra effort can be very expensive.
The claim involved a hearing-impaired patient with lupus erythematosus under treatment by a rheumatologist. For almost 2 years the patient’s partner and her daughter provided translation; but that arrangement was inadequate, she testified, because her partner and daughter were unfamiliar with medical terminology and she was “unable to understand and participate in her care,” which left her “unaware of risks and available alternatives.”
She repeatedly requested that the rheumatologist provide an American Sign Language interpreter for her office visits. He refused on grounds that the cost of an interpreter would exceed the payment he would receive for the visits, which made it an “undue financial burden,” and therefore exempt from ADA requirements.
But the undue-burden exemption is not automatic; it must be demonstrated in court. And the jury decided the rheumatologist’s annual income of $425,000 rendered the cost of an interpreter quite affordable.
The lessons are clear: Physicians must take antidiscrimination laws seriously, particularly when uninsurable issues are involved; and we must be constantly aware of the needs of disabled patients, to be sure their care is not substantially different from that of any other patient.
In the case of hearing-impaired or deaf patients, it is important to remember that forms of communication that are quite adequate for most are not appropriate for some. Lip reading, written notes, and the use of family members as interpreters may be perfectly acceptable to one patient and unsuitable for another.
If the patient agrees to written notes and lip reading, as most do, you need to remember to speak slowly, and to write down critical information to avoid any miscommunications. And as always, it is crucial to document all communication, as well as the methods used for that communication – specifically including the fact that the patient agreed to those forms of communication. Documentation, as I’ve often said, is like garlic: There is no such thing as too much of it.
Should a patient not agree that written notes are sufficient, other alternatives can be offered: computer transcription, assistive listening devices, videotext displays (often available in hospitals), and telecommunication devices such as TTY and TDD. But if the patient rejects all of those options and continues to insist on a professional interpreter, the precedent set by the New Jersey case suggests that you need to acquiesce, even if the interpreter’s fee exceeds the visit reimbursement – and the ADA prohibits you from passing your cost along to the patient. But any such cost will be far less than a noninsured judgment against you.
If you must go that route, make sure the interpreter you hire is familiar with medical terminology, and is not acquainted or related to the patient (for HIPAA reasons). Your state may have an online registry of available interpreters, or your hospital may have a sign language interpreter on its staff that they might allow you to “borrow.”
The good news is several states have responded to this issue by introducing legislation that would require health insurance carriers to pay for the cost of interpreters, although none, as of this writing, have yet become law.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
A recent claim against a New Jersey physician attracted considerable attention in both the medical and legal communities, not only because it resulted in a substantial jury award, but because that award was not covered by malpractice insurance.
It is a good reminder for the rest of us: This case involved a charge of discrimination against a hearing-impaired patient – which meant the physician not only had to fund his own defense, but was personally responsible for the $400,000 award against him.
The Americans with Disabilities Act (ADA) was designed to protect individuals with various disabilities against discrimination in various public situations – including, specifically, “the professional office of a health care professional.”
When the disability is impaired hearing, the law requires physicians to provide any “auxiliary aids and services” that might be necessary to insure clear communication between doctor and patient. In the vast majority of such situations, a pad and pencil will satisfy that requirement. But occasionally it does not, particularly when complex medical concepts are involved; and in such cases, as the New Jersey trial demonstrated, failure to make the necessary extra effort can be very expensive.
The claim involved a hearing-impaired patient with lupus erythematosus under treatment by a rheumatologist. For almost 2 years the patient’s partner and her daughter provided translation; but that arrangement was inadequate, she testified, because her partner and daughter were unfamiliar with medical terminology and she was “unable to understand and participate in her care,” which left her “unaware of risks and available alternatives.”
She repeatedly requested that the rheumatologist provide an American Sign Language interpreter for her office visits. He refused on grounds that the cost of an interpreter would exceed the payment he would receive for the visits, which made it an “undue financial burden,” and therefore exempt from ADA requirements.
But the undue-burden exemption is not automatic; it must be demonstrated in court. And the jury decided the rheumatologist’s annual income of $425,000 rendered the cost of an interpreter quite affordable.
The lessons are clear: Physicians must take antidiscrimination laws seriously, particularly when uninsurable issues are involved; and we must be constantly aware of the needs of disabled patients, to be sure their care is not substantially different from that of any other patient.
In the case of hearing-impaired or deaf patients, it is important to remember that forms of communication that are quite adequate for most are not appropriate for some. Lip reading, written notes, and the use of family members as interpreters may be perfectly acceptable to one patient and unsuitable for another.
If the patient agrees to written notes and lip reading, as most do, you need to remember to speak slowly, and to write down critical information to avoid any miscommunications. And as always, it is crucial to document all communication, as well as the methods used for that communication – specifically including the fact that the patient agreed to those forms of communication. Documentation, as I’ve often said, is like garlic: There is no such thing as too much of it.
Should a patient not agree that written notes are sufficient, other alternatives can be offered: computer transcription, assistive listening devices, videotext displays (often available in hospitals), and telecommunication devices such as TTY and TDD. But if the patient rejects all of those options and continues to insist on a professional interpreter, the precedent set by the New Jersey case suggests that you need to acquiesce, even if the interpreter’s fee exceeds the visit reimbursement – and the ADA prohibits you from passing your cost along to the patient. But any such cost will be far less than a noninsured judgment against you.
If you must go that route, make sure the interpreter you hire is familiar with medical terminology, and is not acquainted or related to the patient (for HIPAA reasons). Your state may have an online registry of available interpreters, or your hospital may have a sign language interpreter on its staff that they might allow you to “borrow.”
The good news is several states have responded to this issue by introducing legislation that would require health insurance carriers to pay for the cost of interpreters, although none, as of this writing, have yet become law.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
A recent claim against a New Jersey physician attracted considerable attention in both the medical and legal communities, not only because it resulted in a substantial jury award, but because that award was not covered by malpractice insurance.
It is a good reminder for the rest of us: This case involved a charge of discrimination against a hearing-impaired patient – which meant the physician not only had to fund his own defense, but was personally responsible for the $400,000 award against him.
The Americans with Disabilities Act (ADA) was designed to protect individuals with various disabilities against discrimination in various public situations – including, specifically, “the professional office of a health care professional.”
When the disability is impaired hearing, the law requires physicians to provide any “auxiliary aids and services” that might be necessary to insure clear communication between doctor and patient. In the vast majority of such situations, a pad and pencil will satisfy that requirement. But occasionally it does not, particularly when complex medical concepts are involved; and in such cases, as the New Jersey trial demonstrated, failure to make the necessary extra effort can be very expensive.
The claim involved a hearing-impaired patient with lupus erythematosus under treatment by a rheumatologist. For almost 2 years the patient’s partner and her daughter provided translation; but that arrangement was inadequate, she testified, because her partner and daughter were unfamiliar with medical terminology and she was “unable to understand and participate in her care,” which left her “unaware of risks and available alternatives.”
She repeatedly requested that the rheumatologist provide an American Sign Language interpreter for her office visits. He refused on grounds that the cost of an interpreter would exceed the payment he would receive for the visits, which made it an “undue financial burden,” and therefore exempt from ADA requirements.
But the undue-burden exemption is not automatic; it must be demonstrated in court. And the jury decided the rheumatologist’s annual income of $425,000 rendered the cost of an interpreter quite affordable.
The lessons are clear: Physicians must take antidiscrimination laws seriously, particularly when uninsurable issues are involved; and we must be constantly aware of the needs of disabled patients, to be sure their care is not substantially different from that of any other patient.
In the case of hearing-impaired or deaf patients, it is important to remember that forms of communication that are quite adequate for most are not appropriate for some. Lip reading, written notes, and the use of family members as interpreters may be perfectly acceptable to one patient and unsuitable for another.
If the patient agrees to written notes and lip reading, as most do, you need to remember to speak slowly, and to write down critical information to avoid any miscommunications. And as always, it is crucial to document all communication, as well as the methods used for that communication – specifically including the fact that the patient agreed to those forms of communication. Documentation, as I’ve often said, is like garlic: There is no such thing as too much of it.
Should a patient not agree that written notes are sufficient, other alternatives can be offered: computer transcription, assistive listening devices, videotext displays (often available in hospitals), and telecommunication devices such as TTY and TDD. But if the patient rejects all of those options and continues to insist on a professional interpreter, the precedent set by the New Jersey case suggests that you need to acquiesce, even if the interpreter’s fee exceeds the visit reimbursement – and the ADA prohibits you from passing your cost along to the patient. But any such cost will be far less than a noninsured judgment against you.
If you must go that route, make sure the interpreter you hire is familiar with medical terminology, and is not acquainted or related to the patient (for HIPAA reasons). Your state may have an online registry of available interpreters, or your hospital may have a sign language interpreter on its staff that they might allow you to “borrow.”
The good news is several states have responded to this issue by introducing legislation that would require health insurance carriers to pay for the cost of interpreters, although none, as of this writing, have yet become law.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
When patients demand vaccinated health care providers
Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:
- Must health care employers ensure that their employees are vaccinated?
- Can health care employers require that their employees be vaccinated?
- Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
- Can a health care employer terminate an employee who refuses vaccination?
- Does a patient have a legal right to a vaccinated health care provider?
At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.
State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.
So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.
The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.
And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:
- U.S. Food and Drug Administration regulation on approval of vaccines
- The Americans With Disabilities Act (ADA)
- The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
- Civil rights laws
- Patients’ rights
FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.
ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.
HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.
Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.
Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.
Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
Employer options
So, what can health care employers do? They have three options:
- Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
- Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
- Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.
Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.
Health care employers should discuss the options with their legal counsel before deciding which option to adopt.
A version of this article first appeared on Medscape.com.
Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:
- Must health care employers ensure that their employees are vaccinated?
- Can health care employers require that their employees be vaccinated?
- Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
- Can a health care employer terminate an employee who refuses vaccination?
- Does a patient have a legal right to a vaccinated health care provider?
At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.
State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.
So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.
The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.
And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:
- U.S. Food and Drug Administration regulation on approval of vaccines
- The Americans With Disabilities Act (ADA)
- The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
- Civil rights laws
- Patients’ rights
FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.
ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.
HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.
Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.
Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.
Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
Employer options
So, what can health care employers do? They have three options:
- Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
- Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
- Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.
Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.
Health care employers should discuss the options with their legal counsel before deciding which option to adopt.
A version of this article first appeared on Medscape.com.
Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:
- Must health care employers ensure that their employees are vaccinated?
- Can health care employers require that their employees be vaccinated?
- Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
- Can a health care employer terminate an employee who refuses vaccination?
- Does a patient have a legal right to a vaccinated health care provider?
At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.
State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.
So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.
The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.
And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:
- U.S. Food and Drug Administration regulation on approval of vaccines
- The Americans With Disabilities Act (ADA)
- The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
- Civil rights laws
- Patients’ rights
FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.
ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.
HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.
Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.
Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.
Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
Employer options
So, what can health care employers do? They have three options:
- Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
- Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
- Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.
Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.
Health care employers should discuss the options with their legal counsel before deciding which option to adopt.
A version of this article first appeared on Medscape.com.
Legislative wins set groundwork for future success
I receive updates and stories every day from rheumatologists and their offices regarding the egregious behavior of various health care entities that profit off patients and harm them in the process. If you know me, you know I’m willing to tell and retell horror stories of pharmacy benefit managers (PBMs), especially of how they construct formularies for the most profit, again, harming patients in the process. It’s critical to serve as a voice to counter the PBM trade group, the Pharmaceutical Care Management Association, which continues to extol how PBMs are essentially saving our country billions ... one restrictive formulary at a time.
It does seem that we are constantly fighting against something:
- Patients arbitrarily being switched to completely different medications to “save” money. These “savings” are pocketed by the middlemen, not the patients or the employers paying for the coverage.
- Copay cards for medications that have no lower-cost alternative. These fill the coffers of the health plans without patients getting credit toward their deductible.
- Mandating that patients move from receiving their infusions under the watchful eye of their rheumatologist’s office to home infusion. This has been shown to be more dangerous for our patients.
- Wasting hours on prior authorization paperwork for needed medication. We know that these are nearly always approved, and thereby delay treatment unnecessarily.
By now you might wonder: “Where is the good news?” In spite of the daily barrage of battles that come our way, rheumatologists continue to do good and improve the lives of our patients. I would go as far as to say that we are prospering in spite of the challenges. Why? Because every day there are wins. Seeing that smile for the first time on the face of a patient who finally has answers and a treatment plan for their newly diagnosed RA. Walking out of the exam room and having patients and their parents give you a hug. Helping a dad be able to walk his daughter down the aisle with ease. On the clinical front, I don’t have to tell you: We score wins every single day.
There is good news on the advocacy side, too. In my own state of Louisiana, this legislative session, we passed a number of bills that are beneficial to our patients, including a bill to stop the aforementioned attacks on copay assistance by state regulated payers. We even blocked one that the Rheumatology Alliance of Louisiana felt would be harmful to our patients. The wins this session follow wins during the previous session, including passage of new and updated laws to put more prescribing power back in the hands of physicians when medication access is unnecessarily restricted by step therapy. While there has been some doubt as to whether these state laws actually work, I can attest that the new Louisiana step therapy law has allowed stable patients to remain on their medication in a number of specialties, including rheumatology and ophthalmology.
My own state of Louisiana is not the only one where the rheumatology community has seen legislative successes, and that speaks to the strength of the network that rheumatologists have built within their states and across the country, as well as our passion for our patients. Just 3 years after the emergence of accumulator programs, 11 states have already seen fit to curtail their use (Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, and West Virginia), and over 20 states considered adopting similar legislation this year. Reforms to the use of step therapy continue their drumbeat across the country, with three more states (Arkansas, Nebraska, and Oregon) having bills signed into law this year. West Virginia took a bold step to reduce patient out-of-pocket costs at the point of sale by an amount commensurate with 100% of rebates received by a PBM. These material policy wins demonstrate how we continue to successfully chip away at the opacity of PBMs and the rebate system, which is truly at the root of so many of the issues affecting our patients’ care.
At the federal level, rheumatologists engage both with Congress and the administration to ensure that our patients’ voices are represented against very well funded and organized forces like insurers and PBMs. Rheumatologists weighed in on issues ranging from Medicaid payment policy, to copay accumulators in the exchanges, to creating transparency and fixing misaligned incentives in the pharmaceutical supply chain. We drive coalition engagement on issues of shared interest with other specialty and provider groups, such as extending a moratorium on Medicare sequestration. We also engage on narrow issues as they arise: For example, I personally testified before Congress that any proposed limitations on pharmaceutical samples must consider the fact that these samples can provide a critical bridge for patients waiting for their insurers to approve their needed medication. And, perhaps most importantly, we have defeated misguided and potentially devastating Part B payment reform models from the Innovation Center three separate times.
There is more work to be done. And to make it easier to find “Rheum for Action” in your daily work, the Coalition of State Rheumatology Organizations has tools on our website that summarize legislation and facilitate engagement with policy makers, including thank you messages to those who supported our priorities to celebrate the good news this year.
So yes, there is good news now, and more to come! I am optimistic that we will continue to see these advocacy wins, which will help to ensure that those hugs we share with our patients will continue long into the future.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.
I receive updates and stories every day from rheumatologists and their offices regarding the egregious behavior of various health care entities that profit off patients and harm them in the process. If you know me, you know I’m willing to tell and retell horror stories of pharmacy benefit managers (PBMs), especially of how they construct formularies for the most profit, again, harming patients in the process. It’s critical to serve as a voice to counter the PBM trade group, the Pharmaceutical Care Management Association, which continues to extol how PBMs are essentially saving our country billions ... one restrictive formulary at a time.
It does seem that we are constantly fighting against something:
- Patients arbitrarily being switched to completely different medications to “save” money. These “savings” are pocketed by the middlemen, not the patients or the employers paying for the coverage.
- Copay cards for medications that have no lower-cost alternative. These fill the coffers of the health plans without patients getting credit toward their deductible.
- Mandating that patients move from receiving their infusions under the watchful eye of their rheumatologist’s office to home infusion. This has been shown to be more dangerous for our patients.
- Wasting hours on prior authorization paperwork for needed medication. We know that these are nearly always approved, and thereby delay treatment unnecessarily.
By now you might wonder: “Where is the good news?” In spite of the daily barrage of battles that come our way, rheumatologists continue to do good and improve the lives of our patients. I would go as far as to say that we are prospering in spite of the challenges. Why? Because every day there are wins. Seeing that smile for the first time on the face of a patient who finally has answers and a treatment plan for their newly diagnosed RA. Walking out of the exam room and having patients and their parents give you a hug. Helping a dad be able to walk his daughter down the aisle with ease. On the clinical front, I don’t have to tell you: We score wins every single day.
There is good news on the advocacy side, too. In my own state of Louisiana, this legislative session, we passed a number of bills that are beneficial to our patients, including a bill to stop the aforementioned attacks on copay assistance by state regulated payers. We even blocked one that the Rheumatology Alliance of Louisiana felt would be harmful to our patients. The wins this session follow wins during the previous session, including passage of new and updated laws to put more prescribing power back in the hands of physicians when medication access is unnecessarily restricted by step therapy. While there has been some doubt as to whether these state laws actually work, I can attest that the new Louisiana step therapy law has allowed stable patients to remain on their medication in a number of specialties, including rheumatology and ophthalmology.
My own state of Louisiana is not the only one where the rheumatology community has seen legislative successes, and that speaks to the strength of the network that rheumatologists have built within their states and across the country, as well as our passion for our patients. Just 3 years after the emergence of accumulator programs, 11 states have already seen fit to curtail their use (Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, and West Virginia), and over 20 states considered adopting similar legislation this year. Reforms to the use of step therapy continue their drumbeat across the country, with three more states (Arkansas, Nebraska, and Oregon) having bills signed into law this year. West Virginia took a bold step to reduce patient out-of-pocket costs at the point of sale by an amount commensurate with 100% of rebates received by a PBM. These material policy wins demonstrate how we continue to successfully chip away at the opacity of PBMs and the rebate system, which is truly at the root of so many of the issues affecting our patients’ care.
At the federal level, rheumatologists engage both with Congress and the administration to ensure that our patients’ voices are represented against very well funded and organized forces like insurers and PBMs. Rheumatologists weighed in on issues ranging from Medicaid payment policy, to copay accumulators in the exchanges, to creating transparency and fixing misaligned incentives in the pharmaceutical supply chain. We drive coalition engagement on issues of shared interest with other specialty and provider groups, such as extending a moratorium on Medicare sequestration. We also engage on narrow issues as they arise: For example, I personally testified before Congress that any proposed limitations on pharmaceutical samples must consider the fact that these samples can provide a critical bridge for patients waiting for their insurers to approve their needed medication. And, perhaps most importantly, we have defeated misguided and potentially devastating Part B payment reform models from the Innovation Center three separate times.
There is more work to be done. And to make it easier to find “Rheum for Action” in your daily work, the Coalition of State Rheumatology Organizations has tools on our website that summarize legislation and facilitate engagement with policy makers, including thank you messages to those who supported our priorities to celebrate the good news this year.
So yes, there is good news now, and more to come! I am optimistic that we will continue to see these advocacy wins, which will help to ensure that those hugs we share with our patients will continue long into the future.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.
I receive updates and stories every day from rheumatologists and their offices regarding the egregious behavior of various health care entities that profit off patients and harm them in the process. If you know me, you know I’m willing to tell and retell horror stories of pharmacy benefit managers (PBMs), especially of how they construct formularies for the most profit, again, harming patients in the process. It’s critical to serve as a voice to counter the PBM trade group, the Pharmaceutical Care Management Association, which continues to extol how PBMs are essentially saving our country billions ... one restrictive formulary at a time.
It does seem that we are constantly fighting against something:
- Patients arbitrarily being switched to completely different medications to “save” money. These “savings” are pocketed by the middlemen, not the patients or the employers paying for the coverage.
- Copay cards for medications that have no lower-cost alternative. These fill the coffers of the health plans without patients getting credit toward their deductible.
- Mandating that patients move from receiving their infusions under the watchful eye of their rheumatologist’s office to home infusion. This has been shown to be more dangerous for our patients.
- Wasting hours on prior authorization paperwork for needed medication. We know that these are nearly always approved, and thereby delay treatment unnecessarily.
By now you might wonder: “Where is the good news?” In spite of the daily barrage of battles that come our way, rheumatologists continue to do good and improve the lives of our patients. I would go as far as to say that we are prospering in spite of the challenges. Why? Because every day there are wins. Seeing that smile for the first time on the face of a patient who finally has answers and a treatment plan for their newly diagnosed RA. Walking out of the exam room and having patients and their parents give you a hug. Helping a dad be able to walk his daughter down the aisle with ease. On the clinical front, I don’t have to tell you: We score wins every single day.
There is good news on the advocacy side, too. In my own state of Louisiana, this legislative session, we passed a number of bills that are beneficial to our patients, including a bill to stop the aforementioned attacks on copay assistance by state regulated payers. We even blocked one that the Rheumatology Alliance of Louisiana felt would be harmful to our patients. The wins this session follow wins during the previous session, including passage of new and updated laws to put more prescribing power back in the hands of physicians when medication access is unnecessarily restricted by step therapy. While there has been some doubt as to whether these state laws actually work, I can attest that the new Louisiana step therapy law has allowed stable patients to remain on their medication in a number of specialties, including rheumatology and ophthalmology.
My own state of Louisiana is not the only one where the rheumatology community has seen legislative successes, and that speaks to the strength of the network that rheumatologists have built within their states and across the country, as well as our passion for our patients. Just 3 years after the emergence of accumulator programs, 11 states have already seen fit to curtail their use (Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, and West Virginia), and over 20 states considered adopting similar legislation this year. Reforms to the use of step therapy continue their drumbeat across the country, with three more states (Arkansas, Nebraska, and Oregon) having bills signed into law this year. West Virginia took a bold step to reduce patient out-of-pocket costs at the point of sale by an amount commensurate with 100% of rebates received by a PBM. These material policy wins demonstrate how we continue to successfully chip away at the opacity of PBMs and the rebate system, which is truly at the root of so many of the issues affecting our patients’ care.
At the federal level, rheumatologists engage both with Congress and the administration to ensure that our patients’ voices are represented against very well funded and organized forces like insurers and PBMs. Rheumatologists weighed in on issues ranging from Medicaid payment policy, to copay accumulators in the exchanges, to creating transparency and fixing misaligned incentives in the pharmaceutical supply chain. We drive coalition engagement on issues of shared interest with other specialty and provider groups, such as extending a moratorium on Medicare sequestration. We also engage on narrow issues as they arise: For example, I personally testified before Congress that any proposed limitations on pharmaceutical samples must consider the fact that these samples can provide a critical bridge for patients waiting for their insurers to approve their needed medication. And, perhaps most importantly, we have defeated misguided and potentially devastating Part B payment reform models from the Innovation Center three separate times.
There is more work to be done. And to make it easier to find “Rheum for Action” in your daily work, the Coalition of State Rheumatology Organizations has tools on our website that summarize legislation and facilitate engagement with policy makers, including thank you messages to those who supported our priorities to celebrate the good news this year.
So yes, there is good news now, and more to come! I am optimistic that we will continue to see these advocacy wins, which will help to ensure that those hugs we share with our patients will continue long into the future.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.
A healthy family who had been living in Brazil presented with crusted plaques on their extremities
Trypanosomatidae
Leishmaniasis is caused by protozoa of the family Trypanosomatidae, called Leishmania. The vector is a sandfly infected with the protozoa.1
The three main forms of leishmaniasis – cutaneous, mucocutaneous, or visceral – varies with the species of organism involved, the geographic distribution, and the immune response of the patient. A majority of the cases seen in the United States are from patients who contracted the disease elsewhere, particularly from Peru and Brazil.2
Lesions can vary from asymptomatic to severe. The initial lesion typically develops within weeks or months, and presents as an erythematous papule that is seen at the bite site.3 The papule evolves into a nodule or plaque that may ulcerate and crust.3 The ulcer can be distinguished by a raised and distinct border. In older stages, atrophic scarring may be seen. In some cases, the lesions may present years after exposure, because of immunosuppression or trauma.
Histology of CL reveals tuberculoid granulomas with parasitized histiocytes present. Amastigotes with distinct nuclei and kinetoplasts characterize Leishmania.2 In addition to histology, the biopsy may be sent for the press-imprint-smear method (PIS). In a study of 75 patients, the PIS method showed a higher sensitivity, as well as being a less costly and more rapid option for diagnosis.5
The treatment depends on the severity of the lesion and the species of the Leishmania genus. Mild lesions may resolve spontaneously. Topical imiquimod, cryotherapy, photodynamic therapy, and heat therapy may aid in the healing process.5 Systemic azole antifungal medications, miltefosine, and amphotericin B, and pentamidine may be used for more persistent lesions. In very severe cases, pentavalent antimonials (sodium stibogluconate, Pentostam) may be administered intravenously, although there is a high occurrence of recorded side effects.2
This case and the photos were submitted by Sabrina Liao, BS, University of California, San Diego; and Brooke Resh Sateesh, MD, San Diego Family Dermatology The case was edited by Donna Bilu Martin, MD.
References
1. Leishmaniasis – Resources for Health Professionals. Centers for Disease Control and Prevention. 2021 Jun 3.
2. Stark CG. Leishmaniasis. Medscape. 2020 Feb 18.
3. Markle WH and Makhoul K. Am Fam Physician. 2004 Mar 15;69(6):1455-604.
4. Ngan V. Leishmaniasis. DermNet NZ. 2017 Jan. 7.
5. Sousa AQ et al. Am J Trop Med Hyg. 2014 Nov;91(5):905-7.
Trypanosomatidae
Leishmaniasis is caused by protozoa of the family Trypanosomatidae, called Leishmania. The vector is a sandfly infected with the protozoa.1
The three main forms of leishmaniasis – cutaneous, mucocutaneous, or visceral – varies with the species of organism involved, the geographic distribution, and the immune response of the patient. A majority of the cases seen in the United States are from patients who contracted the disease elsewhere, particularly from Peru and Brazil.2
Lesions can vary from asymptomatic to severe. The initial lesion typically develops within weeks or months, and presents as an erythematous papule that is seen at the bite site.3 The papule evolves into a nodule or plaque that may ulcerate and crust.3 The ulcer can be distinguished by a raised and distinct border. In older stages, atrophic scarring may be seen. In some cases, the lesions may present years after exposure, because of immunosuppression or trauma.
Histology of CL reveals tuberculoid granulomas with parasitized histiocytes present. Amastigotes with distinct nuclei and kinetoplasts characterize Leishmania.2 In addition to histology, the biopsy may be sent for the press-imprint-smear method (PIS). In a study of 75 patients, the PIS method showed a higher sensitivity, as well as being a less costly and more rapid option for diagnosis.5
The treatment depends on the severity of the lesion and the species of the Leishmania genus. Mild lesions may resolve spontaneously. Topical imiquimod, cryotherapy, photodynamic therapy, and heat therapy may aid in the healing process.5 Systemic azole antifungal medications, miltefosine, and amphotericin B, and pentamidine may be used for more persistent lesions. In very severe cases, pentavalent antimonials (sodium stibogluconate, Pentostam) may be administered intravenously, although there is a high occurrence of recorded side effects.2
This case and the photos were submitted by Sabrina Liao, BS, University of California, San Diego; and Brooke Resh Sateesh, MD, San Diego Family Dermatology The case was edited by Donna Bilu Martin, MD.
References
1. Leishmaniasis – Resources for Health Professionals. Centers for Disease Control and Prevention. 2021 Jun 3.
2. Stark CG. Leishmaniasis. Medscape. 2020 Feb 18.
3. Markle WH and Makhoul K. Am Fam Physician. 2004 Mar 15;69(6):1455-604.
4. Ngan V. Leishmaniasis. DermNet NZ. 2017 Jan. 7.
5. Sousa AQ et al. Am J Trop Med Hyg. 2014 Nov;91(5):905-7.
Trypanosomatidae
Leishmaniasis is caused by protozoa of the family Trypanosomatidae, called Leishmania. The vector is a sandfly infected with the protozoa.1
The three main forms of leishmaniasis – cutaneous, mucocutaneous, or visceral – varies with the species of organism involved, the geographic distribution, and the immune response of the patient. A majority of the cases seen in the United States are from patients who contracted the disease elsewhere, particularly from Peru and Brazil.2
Lesions can vary from asymptomatic to severe. The initial lesion typically develops within weeks or months, and presents as an erythematous papule that is seen at the bite site.3 The papule evolves into a nodule or plaque that may ulcerate and crust.3 The ulcer can be distinguished by a raised and distinct border. In older stages, atrophic scarring may be seen. In some cases, the lesions may present years after exposure, because of immunosuppression or trauma.
Histology of CL reveals tuberculoid granulomas with parasitized histiocytes present. Amastigotes with distinct nuclei and kinetoplasts characterize Leishmania.2 In addition to histology, the biopsy may be sent for the press-imprint-smear method (PIS). In a study of 75 patients, the PIS method showed a higher sensitivity, as well as being a less costly and more rapid option for diagnosis.5
The treatment depends on the severity of the lesion and the species of the Leishmania genus. Mild lesions may resolve spontaneously. Topical imiquimod, cryotherapy, photodynamic therapy, and heat therapy may aid in the healing process.5 Systemic azole antifungal medications, miltefosine, and amphotericin B, and pentamidine may be used for more persistent lesions. In very severe cases, pentavalent antimonials (sodium stibogluconate, Pentostam) may be administered intravenously, although there is a high occurrence of recorded side effects.2
This case and the photos were submitted by Sabrina Liao, BS, University of California, San Diego; and Brooke Resh Sateesh, MD, San Diego Family Dermatology The case was edited by Donna Bilu Martin, MD.
References
1. Leishmaniasis – Resources for Health Professionals. Centers for Disease Control and Prevention. 2021 Jun 3.
2. Stark CG. Leishmaniasis. Medscape. 2020 Feb 18.
3. Markle WH and Makhoul K. Am Fam Physician. 2004 Mar 15;69(6):1455-604.
4. Ngan V. Leishmaniasis. DermNet NZ. 2017 Jan. 7.
5. Sousa AQ et al. Am J Trop Med Hyg. 2014 Nov;91(5):905-7.
