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Rozlytrek approved for ROS1-positive metastatic NSCLC, cancers with NTRK gene fusion defects
Rozlytrek (entrectinib) has been approved to treat cancers with neurotrophic tyrosine receptor kinase (NTRK) gene fusion defects in adults and adolescents for whom there are no effective treatments, the Food and Drug Administration announced in a press release.
Entrectinib was also approved for the treatment of adults with metastatic non–small cell lung cancers that are ROS1-positive.
“We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue-agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” FDA Acting Commissioner Ned Sharpless, MD, said in the release.
This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than on the original tumor’s location. The previous tissue-agnostic indications approved by the FDA were pembrolizumab (Keytruda) for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017 and larotrectinib (Vitrakvi) for NTRK gene fusion tumors in 2018.
The approval of entrectinib was granted to Genentech. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a separate press release.
Foundation Medicine will submit Foundation One CDx to the FDA for approval as a companion diagnostic for entrectinib, according to the Genentech release; an FDA-approved companion diagnostic for entrectinib is not available at this time.
“Today’s approval includes an indication for pediatric patients, 12 years of age and older, who have NTRK fusion–positive tumors by relying on efficacy information obtained primarily in adults,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Efficacy in adolescents was derived from adult data and safety was demonstrated in 30 pediatric patients.”
Entrectinib was evaluated in four clinical trials that included 54 adults with NTRK fusion–positive tumors. The overall response rate was 57%, with 7.4% of patients having complete disappearance of the tumor. Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for 9 months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid, and colon/rectum.
Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.
The most serious side effects of entrectinib are heart failure, central nervous system effects, changes in sleep pattern, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation, and vision disorders. Females of reproductive age and males with a female partner of reproductive potential are advised to use effective contraception during treatment; the drug may cause harm to a developing fetus or newborn baby.
Genentech must provide additional clinical trial data to the FDA as a condition of the approval.
Rozlytrek (entrectinib) has been approved to treat cancers with neurotrophic tyrosine receptor kinase (NTRK) gene fusion defects in adults and adolescents for whom there are no effective treatments, the Food and Drug Administration announced in a press release.
Entrectinib was also approved for the treatment of adults with metastatic non–small cell lung cancers that are ROS1-positive.
“We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue-agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” FDA Acting Commissioner Ned Sharpless, MD, said in the release.
This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than on the original tumor’s location. The previous tissue-agnostic indications approved by the FDA were pembrolizumab (Keytruda) for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017 and larotrectinib (Vitrakvi) for NTRK gene fusion tumors in 2018.
The approval of entrectinib was granted to Genentech. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a separate press release.
Foundation Medicine will submit Foundation One CDx to the FDA for approval as a companion diagnostic for entrectinib, according to the Genentech release; an FDA-approved companion diagnostic for entrectinib is not available at this time.
“Today’s approval includes an indication for pediatric patients, 12 years of age and older, who have NTRK fusion–positive tumors by relying on efficacy information obtained primarily in adults,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Efficacy in adolescents was derived from adult data and safety was demonstrated in 30 pediatric patients.”
Entrectinib was evaluated in four clinical trials that included 54 adults with NTRK fusion–positive tumors. The overall response rate was 57%, with 7.4% of patients having complete disappearance of the tumor. Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for 9 months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid, and colon/rectum.
Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.
The most serious side effects of entrectinib are heart failure, central nervous system effects, changes in sleep pattern, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation, and vision disorders. Females of reproductive age and males with a female partner of reproductive potential are advised to use effective contraception during treatment; the drug may cause harm to a developing fetus or newborn baby.
Genentech must provide additional clinical trial data to the FDA as a condition of the approval.
Rozlytrek (entrectinib) has been approved to treat cancers with neurotrophic tyrosine receptor kinase (NTRK) gene fusion defects in adults and adolescents for whom there are no effective treatments, the Food and Drug Administration announced in a press release.
Entrectinib was also approved for the treatment of adults with metastatic non–small cell lung cancers that are ROS1-positive.
“We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue-agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” FDA Acting Commissioner Ned Sharpless, MD, said in the release.
This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than on the original tumor’s location. The previous tissue-agnostic indications approved by the FDA were pembrolizumab (Keytruda) for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017 and larotrectinib (Vitrakvi) for NTRK gene fusion tumors in 2018.
The approval of entrectinib was granted to Genentech. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a separate press release.
Foundation Medicine will submit Foundation One CDx to the FDA for approval as a companion diagnostic for entrectinib, according to the Genentech release; an FDA-approved companion diagnostic for entrectinib is not available at this time.
“Today’s approval includes an indication for pediatric patients, 12 years of age and older, who have NTRK fusion–positive tumors by relying on efficacy information obtained primarily in adults,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Efficacy in adolescents was derived from adult data and safety was demonstrated in 30 pediatric patients.”
Entrectinib was evaluated in four clinical trials that included 54 adults with NTRK fusion–positive tumors. The overall response rate was 57%, with 7.4% of patients having complete disappearance of the tumor. Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for 9 months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid, and colon/rectum.
Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.
The most serious side effects of entrectinib are heart failure, central nervous system effects, changes in sleep pattern, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation, and vision disorders. Females of reproductive age and males with a female partner of reproductive potential are advised to use effective contraception during treatment; the drug may cause harm to a developing fetus or newborn baby.
Genentech must provide additional clinical trial data to the FDA as a condition of the approval.
Consider hormones and mood in adolescent girls
Prior to puberty, the rate of mood disorders in males and females is roughly the same; however in adolescence, depression doubles in (biological) girls. While the association isn’t clear, it is reasonable to consider that hormones may be involved, at least for some. For instance, we know that menstrual cycle–related mood changes have been noted since the time of Hippocrates. In this article, I will discuss premenstrual dysphoric disorder (PMDD), as well as potential mood-related side effects of hormonal contraceptives. Because I am talking about physiology, I will be referring to individuals born as biological females in the absence of any hormonal gender treatments, regardless of identified gender.
Many young women will acknowledge somatic and/or psychological symptoms that occur in the luteal phase of their cycle, most commonly in the week before menses begins. The most common somatic symptom is bloating, and mood symptoms are irritability and mood lability.1 To meet criteria for premenstrual syndrome (PMS), a woman must endorse one symptom that causes impairment in their functioning and reoccurs over consecutive cycles. PMDD is more specific and involves five or more affective symptoms, at least one of which is consistent with depressed mood, irritability, anxiety, or mood lability. The other potential symptoms include impaired concentration, fatigue, insomnia or hypersomnia, anhedonia, and appetite issues, all of which are included as criteria for major depression. The population prevalence has been quoted between 2% and 5% and is relatively stable across cultures.1 It tends to be highly genetic, as well as highly comorbid with other psychiatric disorders.2 Girls and women with higher rates of trauma appear to be more likely to experience symptoms,3 which indicates there are environmental influences that can interact with genetic vulnerability.
Interestingly, studies have not found differences in serum hormone levels between those with PMDD and others, which leads to the hypothesis that the main difference is in a woman’s sensitivity to circulating hormones,4 and there has been some evidence of different concentrations of neurotransmitters between affected and unaffected women. Many hormone-neurotransmitter interactions have been described, but two that have received the most attention include the relationship between progesterone, its main metabolite allopregnanolone, and gamma-aminobutyric acid (GABA) receptors. Allopregnanolone, which interacts with GABA receptors similarly to benzodiazepines, tends to be higher in the luteal phase, rising with progesterone, and the concentration quickly recedes at the onset of menses as progesterone levels drop off. The other highly notable relationship is the positive association between estradiol and the expression of the serotonin transporter (SERT) genes, which can potentially lead to higher levels of circulating serotonin in the follicular phase.
When PMDD is suspected in an adolescent who presents with intermittent mood and anxiety symptoms that lessen or disappear at baseline and appear unrelated to circumstances, it is important to check in regarding monthly patterns. It can be challenging for adolescents to make this connection, and even more so prior to achieving cycle regularity. Observational studies suggest that by age 14 years, about 82% of girls have a regular cycle.5 The best way to help a patient make the connection is to suggest a period tracking app on their smartphone or tablet. There are many available period trackers that track mood as well and are free to download. Sometimes, simply the act of tracking and bringing awareness to the pattern is therapeutic in itself; sometimes, more formal treatment is needed.
Once the diagnosis of PMDD has been established, there are several options for treatment that range from supplements and herbal remedies to SSRIs, as well as psychotherapy. Treatment may begin with calcium supplements (1,200 mg have been effective in reducing symptoms)6 and referral for cognitive-behavioral therapy (CBT). CBT appears to be associated with a shift in the ability to attribute symptoms to hormones,7 which can help decrease hopelessness and reactivity. SSRIs are another effective strategy to treat PMDD, both taken daily and continuously and also taken in a pulsed fashion, starting with the onset of symptoms or 7-10 days before the period starts and stopping on the first day of menses. Low doses of sertraline, fluoxetine, paroxetine, escitalopram and citalopram have been studied.8 There is some low-quality evidence for herbal supplements as well, probably the most consistent finding is for Vitex taken the week prior to menses.9 Finally, certain oral contraceptives have been associated with PMDD symptom reduction, specifically formulations with 3 mg of drospirenone (a fourth generation progesterone) and 20 mcg of ethinyl estradiol.10 Other formulations, including progesterone-only pills, have not been helpful and have been demonstrated to have a negative effect on mood.11
The literature on hormonal contraceptives and mood can be confusing. While oral agents containing drospirenone have been helpful for premenstrual dysphoria, other studies outside of the PMDD literature have found positive associations between oral contraceptives and depression in adolescents.11 Girls taking combined oral contraceptives seem to be at a 1.8-fold risk of depression, while girls taking progesterone-only formulations were at 2.2 times the risk of developing depression, compared with girls who weren’t taking anything. These days, more pediatricians are recommending long acting reversible contraceptives (LARCs), and there is some thought that even these may carry some risk, but this remains to be studied.
In conclusion, As a provider, you are in a special position to help your patients by bringing nonjudgmental awareness to the potential contribution of their own cyclical hormones or that of exogenous hormones associated with contraceptive choices. Whether it means switching contraceptives, adding calcium or starting a low dose SSRI for 1 week a month, there are many ways to approach symptoms. Often, simply helping make the connection between physiology and mood can be empowering.
Dr. Guth is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and the University of Vermont, both in Burlington. Email her at [email protected].
References
1. Am J Psychiatry. 2012 May;169(5):465-75.
2. Arch Womens Ment Health. 2004 Feb;7(1):37-47.
3. Arch Womens Ment Health. 2011 Oct;14(5):383-93.
4. Curr Psychiatry Rep. 2015 Nov;17(11):87.
5. Ital J Pediatr. 2012 Aug 14;38:38.
6. Am J Obstet Gynecol. 1998 Aug;179(2):444-52.
7. J Clin Psychol Med Settings. 2012 Sep;19(3):308-19.
8. Cochrane Database Syst Rev. 2013 Jun 7;(6):CD001396.
9. J Psychosom Obstet Gynaecol. 2011 Mar;32(1):42-51.
10. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006586.
11. PLoS One. 2018 Mar 22;13(3):e0194773.
Prior to puberty, the rate of mood disorders in males and females is roughly the same; however in adolescence, depression doubles in (biological) girls. While the association isn’t clear, it is reasonable to consider that hormones may be involved, at least for some. For instance, we know that menstrual cycle–related mood changes have been noted since the time of Hippocrates. In this article, I will discuss premenstrual dysphoric disorder (PMDD), as well as potential mood-related side effects of hormonal contraceptives. Because I am talking about physiology, I will be referring to individuals born as biological females in the absence of any hormonal gender treatments, regardless of identified gender.
Many young women will acknowledge somatic and/or psychological symptoms that occur in the luteal phase of their cycle, most commonly in the week before menses begins. The most common somatic symptom is bloating, and mood symptoms are irritability and mood lability.1 To meet criteria for premenstrual syndrome (PMS), a woman must endorse one symptom that causes impairment in their functioning and reoccurs over consecutive cycles. PMDD is more specific and involves five or more affective symptoms, at least one of which is consistent with depressed mood, irritability, anxiety, or mood lability. The other potential symptoms include impaired concentration, fatigue, insomnia or hypersomnia, anhedonia, and appetite issues, all of which are included as criteria for major depression. The population prevalence has been quoted between 2% and 5% and is relatively stable across cultures.1 It tends to be highly genetic, as well as highly comorbid with other psychiatric disorders.2 Girls and women with higher rates of trauma appear to be more likely to experience symptoms,3 which indicates there are environmental influences that can interact with genetic vulnerability.
Interestingly, studies have not found differences in serum hormone levels between those with PMDD and others, which leads to the hypothesis that the main difference is in a woman’s sensitivity to circulating hormones,4 and there has been some evidence of different concentrations of neurotransmitters between affected and unaffected women. Many hormone-neurotransmitter interactions have been described, but two that have received the most attention include the relationship between progesterone, its main metabolite allopregnanolone, and gamma-aminobutyric acid (GABA) receptors. Allopregnanolone, which interacts with GABA receptors similarly to benzodiazepines, tends to be higher in the luteal phase, rising with progesterone, and the concentration quickly recedes at the onset of menses as progesterone levels drop off. The other highly notable relationship is the positive association between estradiol and the expression of the serotonin transporter (SERT) genes, which can potentially lead to higher levels of circulating serotonin in the follicular phase.
When PMDD is suspected in an adolescent who presents with intermittent mood and anxiety symptoms that lessen or disappear at baseline and appear unrelated to circumstances, it is important to check in regarding monthly patterns. It can be challenging for adolescents to make this connection, and even more so prior to achieving cycle regularity. Observational studies suggest that by age 14 years, about 82% of girls have a regular cycle.5 The best way to help a patient make the connection is to suggest a period tracking app on their smartphone or tablet. There are many available period trackers that track mood as well and are free to download. Sometimes, simply the act of tracking and bringing awareness to the pattern is therapeutic in itself; sometimes, more formal treatment is needed.
Once the diagnosis of PMDD has been established, there are several options for treatment that range from supplements and herbal remedies to SSRIs, as well as psychotherapy. Treatment may begin with calcium supplements (1,200 mg have been effective in reducing symptoms)6 and referral for cognitive-behavioral therapy (CBT). CBT appears to be associated with a shift in the ability to attribute symptoms to hormones,7 which can help decrease hopelessness and reactivity. SSRIs are another effective strategy to treat PMDD, both taken daily and continuously and also taken in a pulsed fashion, starting with the onset of symptoms or 7-10 days before the period starts and stopping on the first day of menses. Low doses of sertraline, fluoxetine, paroxetine, escitalopram and citalopram have been studied.8 There is some low-quality evidence for herbal supplements as well, probably the most consistent finding is for Vitex taken the week prior to menses.9 Finally, certain oral contraceptives have been associated with PMDD symptom reduction, specifically formulations with 3 mg of drospirenone (a fourth generation progesterone) and 20 mcg of ethinyl estradiol.10 Other formulations, including progesterone-only pills, have not been helpful and have been demonstrated to have a negative effect on mood.11
The literature on hormonal contraceptives and mood can be confusing. While oral agents containing drospirenone have been helpful for premenstrual dysphoria, other studies outside of the PMDD literature have found positive associations between oral contraceptives and depression in adolescents.11 Girls taking combined oral contraceptives seem to be at a 1.8-fold risk of depression, while girls taking progesterone-only formulations were at 2.2 times the risk of developing depression, compared with girls who weren’t taking anything. These days, more pediatricians are recommending long acting reversible contraceptives (LARCs), and there is some thought that even these may carry some risk, but this remains to be studied.
In conclusion, As a provider, you are in a special position to help your patients by bringing nonjudgmental awareness to the potential contribution of their own cyclical hormones or that of exogenous hormones associated with contraceptive choices. Whether it means switching contraceptives, adding calcium or starting a low dose SSRI for 1 week a month, there are many ways to approach symptoms. Often, simply helping make the connection between physiology and mood can be empowering.
Dr. Guth is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and the University of Vermont, both in Burlington. Email her at [email protected].
References
1. Am J Psychiatry. 2012 May;169(5):465-75.
2. Arch Womens Ment Health. 2004 Feb;7(1):37-47.
3. Arch Womens Ment Health. 2011 Oct;14(5):383-93.
4. Curr Psychiatry Rep. 2015 Nov;17(11):87.
5. Ital J Pediatr. 2012 Aug 14;38:38.
6. Am J Obstet Gynecol. 1998 Aug;179(2):444-52.
7. J Clin Psychol Med Settings. 2012 Sep;19(3):308-19.
8. Cochrane Database Syst Rev. 2013 Jun 7;(6):CD001396.
9. J Psychosom Obstet Gynaecol. 2011 Mar;32(1):42-51.
10. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006586.
11. PLoS One. 2018 Mar 22;13(3):e0194773.
Prior to puberty, the rate of mood disorders in males and females is roughly the same; however in adolescence, depression doubles in (biological) girls. While the association isn’t clear, it is reasonable to consider that hormones may be involved, at least for some. For instance, we know that menstrual cycle–related mood changes have been noted since the time of Hippocrates. In this article, I will discuss premenstrual dysphoric disorder (PMDD), as well as potential mood-related side effects of hormonal contraceptives. Because I am talking about physiology, I will be referring to individuals born as biological females in the absence of any hormonal gender treatments, regardless of identified gender.
Many young women will acknowledge somatic and/or psychological symptoms that occur in the luteal phase of their cycle, most commonly in the week before menses begins. The most common somatic symptom is bloating, and mood symptoms are irritability and mood lability.1 To meet criteria for premenstrual syndrome (PMS), a woman must endorse one symptom that causes impairment in their functioning and reoccurs over consecutive cycles. PMDD is more specific and involves five or more affective symptoms, at least one of which is consistent with depressed mood, irritability, anxiety, or mood lability. The other potential symptoms include impaired concentration, fatigue, insomnia or hypersomnia, anhedonia, and appetite issues, all of which are included as criteria for major depression. The population prevalence has been quoted between 2% and 5% and is relatively stable across cultures.1 It tends to be highly genetic, as well as highly comorbid with other psychiatric disorders.2 Girls and women with higher rates of trauma appear to be more likely to experience symptoms,3 which indicates there are environmental influences that can interact with genetic vulnerability.
Interestingly, studies have not found differences in serum hormone levels between those with PMDD and others, which leads to the hypothesis that the main difference is in a woman’s sensitivity to circulating hormones,4 and there has been some evidence of different concentrations of neurotransmitters between affected and unaffected women. Many hormone-neurotransmitter interactions have been described, but two that have received the most attention include the relationship between progesterone, its main metabolite allopregnanolone, and gamma-aminobutyric acid (GABA) receptors. Allopregnanolone, which interacts with GABA receptors similarly to benzodiazepines, tends to be higher in the luteal phase, rising with progesterone, and the concentration quickly recedes at the onset of menses as progesterone levels drop off. The other highly notable relationship is the positive association between estradiol and the expression of the serotonin transporter (SERT) genes, which can potentially lead to higher levels of circulating serotonin in the follicular phase.
When PMDD is suspected in an adolescent who presents with intermittent mood and anxiety symptoms that lessen or disappear at baseline and appear unrelated to circumstances, it is important to check in regarding monthly patterns. It can be challenging for adolescents to make this connection, and even more so prior to achieving cycle regularity. Observational studies suggest that by age 14 years, about 82% of girls have a regular cycle.5 The best way to help a patient make the connection is to suggest a period tracking app on their smartphone or tablet. There are many available period trackers that track mood as well and are free to download. Sometimes, simply the act of tracking and bringing awareness to the pattern is therapeutic in itself; sometimes, more formal treatment is needed.
Once the diagnosis of PMDD has been established, there are several options for treatment that range from supplements and herbal remedies to SSRIs, as well as psychotherapy. Treatment may begin with calcium supplements (1,200 mg have been effective in reducing symptoms)6 and referral for cognitive-behavioral therapy (CBT). CBT appears to be associated with a shift in the ability to attribute symptoms to hormones,7 which can help decrease hopelessness and reactivity. SSRIs are another effective strategy to treat PMDD, both taken daily and continuously and also taken in a pulsed fashion, starting with the onset of symptoms or 7-10 days before the period starts and stopping on the first day of menses. Low doses of sertraline, fluoxetine, paroxetine, escitalopram and citalopram have been studied.8 There is some low-quality evidence for herbal supplements as well, probably the most consistent finding is for Vitex taken the week prior to menses.9 Finally, certain oral contraceptives have been associated with PMDD symptom reduction, specifically formulations with 3 mg of drospirenone (a fourth generation progesterone) and 20 mcg of ethinyl estradiol.10 Other formulations, including progesterone-only pills, have not been helpful and have been demonstrated to have a negative effect on mood.11
The literature on hormonal contraceptives and mood can be confusing. While oral agents containing drospirenone have been helpful for premenstrual dysphoria, other studies outside of the PMDD literature have found positive associations between oral contraceptives and depression in adolescents.11 Girls taking combined oral contraceptives seem to be at a 1.8-fold risk of depression, while girls taking progesterone-only formulations were at 2.2 times the risk of developing depression, compared with girls who weren’t taking anything. These days, more pediatricians are recommending long acting reversible contraceptives (LARCs), and there is some thought that even these may carry some risk, but this remains to be studied.
In conclusion, As a provider, you are in a special position to help your patients by bringing nonjudgmental awareness to the potential contribution of their own cyclical hormones or that of exogenous hormones associated with contraceptive choices. Whether it means switching contraceptives, adding calcium or starting a low dose SSRI for 1 week a month, there are many ways to approach symptoms. Often, simply helping make the connection between physiology and mood can be empowering.
Dr. Guth is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and the University of Vermont, both in Burlington. Email her at [email protected].
References
1. Am J Psychiatry. 2012 May;169(5):465-75.
2. Arch Womens Ment Health. 2004 Feb;7(1):37-47.
3. Arch Womens Ment Health. 2011 Oct;14(5):383-93.
4. Curr Psychiatry Rep. 2015 Nov;17(11):87.
5. Ital J Pediatr. 2012 Aug 14;38:38.
6. Am J Obstet Gynecol. 1998 Aug;179(2):444-52.
7. J Clin Psychol Med Settings. 2012 Sep;19(3):308-19.
8. Cochrane Database Syst Rev. 2013 Jun 7;(6):CD001396.
9. J Psychosom Obstet Gynaecol. 2011 Mar;32(1):42-51.
10. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006586.
11. PLoS One. 2018 Mar 22;13(3):e0194773.
ALERT: Grandmother in the room!
One of the things that makes pediatrics challenging and potentially rewarding is that there are often multiple family members in the room for our visits.
With an expansion of our acknowledged role safeguarding and promoting a child’s current and future health to include asking about environmental and caregiving influences comes some tricky dynamics. The parent is in the room with a teen who has a secret love life. A father is in the room with the mother he threatens at home. The mother is in the room with the preschooler she has hit. There is risk but also opportunity for valuable discourse, discovery, and healing.
We now know that about 50% of the future morbidity of the child before us will be determined by the adverse childhood experiences (ACEs) they experience during the exact years (0-18) they are under our health supervision. Many of these risk factors come from home life and may be preventable or at least moderated. When we begin screening for ACEs we are asking the parents about bad things that happened when they were growing up.
The dilemma that came up recently was the grandmother in the room with the daughter she raised who is now caring for her own child. In this situation, you may be in the presence of the person whom the parent feels inflicted – or failed to prevent – the hurts being discussed.
“How are things at home?” you ask dutifully. Mother says “Fine,” but rolls her eyes. Grandma, sitting in the room looking at her phone, says something to the mother in a foreign language. You are in the dark, but sense friction.
Even in modern times, it is respectful to address the grandparent who is present first in a visit, introducing yourself, and finding out the relationship and living situation. Previsit questionnaires can help set visit priorities and alert you to what topics may be better discussed in private, perhaps including ACEs. It is important to ask the parent permission to discuss potentially sensitive topics when the grandparent is present or ask for the grandparent to step out of the room.
Why not just be sure the grandmother stays in the waiting room? If the hurts from the past still are affecting the mother now, moderating an open conversation about those experiences can be very valuable to reducing their impact on present parenting or dysfunctional coping strategies.
Some experts say that any enumeration of ACEs should include asking “Which of these are still bothering you now?” Saying, “Parenting often brings up memories of similar situations from when we were young that can tilt how we act toward our own children,” then asking, “Can we talk about those experiences you had?”
Eliciting the grandparent’s perspective with a question such as “What were those years of parenting like for you?” respects the significance of the grandparent’s role. The grandparents probably were young, stressed, and inexperienced when they were the mother’s primary caregivers. Or the grandparent may have gratefully erased memories of the tough moments but the parent clearly remembers the childhood pain, because hurts sear themselves into our brains more than positive or neutral experiences do. She or he may have been holding resentment against the grandparent and living it out for years and now in her/his parenting.
Suddenly, you and the parent may hear the grandparent reveal other factors that would never have been visible to the child then and may never have been brought up because the grandparent was working three jobs because the father was deployed; caring for a sick sibling; suffering from depression; being subject to an abusive alcoholic spouse; having to keep the children inside because of shooting in the neighborhood, etc. You may be able reframe what is said to point out that the grandparents “did the best they could at the time and with the resources and skills they possessed then.”
Mothers who had troubled relationships with their own mothers (e.g. insecure attachment) tend to pass these patterns down in their own parenting unless they have processed the experiences and come to a place of acceptance. People may process their past effectively on their own, some through mental health counseling or religion, but for others a brief “Ah ha!” moment may help settle the waters.
Ask the grandparent as well as the parent, “What are you hoping will go differently than when [parent] was growing up?” Some try to make up for what they see as their own mistakes by advocating coming down harder on their grandchildren than they did on their own. An example among my patients was the grandmother whose daughter had become a heroin user, who was very strict and critical in her determination that her granddaughter would not fall into the wrong crowd. Voicing this for her as a possible reason for her strident posture dramatically shifted her attitude.
Other times parents, maybe grateful for a place to live with the grandparents but also trapped there financially, are simmering with anger at the grandparents’ intrusions into their parenting choices. It can be useful to point out that grandparents, no longer caught up in careers, may feel the need to be useful and have a role by giving advice or bustling around cleaning and buying things for their grandchildren. Hey, any help can be welcome if you don’t take it as meaning you are not doing a good job! Although limits can be set.
Transitioning to regarding one’s grown child as an adult and letting them make their own choices and mistakes, waiting until asked for advice, can take a lot of tongue biting after years of active parenting. One essay I read about an adult’s fond memories of his father included the realization that some of the best parenting he recalled was when his father left things unsaid.
Cultural differences in parenting between grandparent and parent can be another source of stress. Assimilation happens fast in America. The newest generation is often trying very hard NOT to be like the “old country.” The parents’ turning away from the grandparents’ culture or religion can threaten their values and culture for which they may have sacrificed everything. Advising the parent to celebrate at least some traditions may reduce the tension at little cost.
As of 2016, 5% of U.S. children in two-parent families lived with a grandparent and 15% of single parents do. This is much higher in certain ethnic groups where living with your adult children is expected. Even if not living together, their influence may be great. Many parents report more stress than support from grandparents. Negative mother-in-law stories abound! That is why simply asking if the parent “has anyone to help them” as a way of assessing social support can be very misleading. You also may ask “Is that more a help or a problem?”
When grandparents undermine the parents’ rules, of course, a family meeting is in order. But grandparents, with the wisdom of years and reduced life pressure, tend to care for children more generously and less critically than when they were main caregivers, conveying unconditional love that can buffer stresses and be remembered by the beloved child forever.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
One of the things that makes pediatrics challenging and potentially rewarding is that there are often multiple family members in the room for our visits.
With an expansion of our acknowledged role safeguarding and promoting a child’s current and future health to include asking about environmental and caregiving influences comes some tricky dynamics. The parent is in the room with a teen who has a secret love life. A father is in the room with the mother he threatens at home. The mother is in the room with the preschooler she has hit. There is risk but also opportunity for valuable discourse, discovery, and healing.
We now know that about 50% of the future morbidity of the child before us will be determined by the adverse childhood experiences (ACEs) they experience during the exact years (0-18) they are under our health supervision. Many of these risk factors come from home life and may be preventable or at least moderated. When we begin screening for ACEs we are asking the parents about bad things that happened when they were growing up.
The dilemma that came up recently was the grandmother in the room with the daughter she raised who is now caring for her own child. In this situation, you may be in the presence of the person whom the parent feels inflicted – or failed to prevent – the hurts being discussed.
“How are things at home?” you ask dutifully. Mother says “Fine,” but rolls her eyes. Grandma, sitting in the room looking at her phone, says something to the mother in a foreign language. You are in the dark, but sense friction.
Even in modern times, it is respectful to address the grandparent who is present first in a visit, introducing yourself, and finding out the relationship and living situation. Previsit questionnaires can help set visit priorities and alert you to what topics may be better discussed in private, perhaps including ACEs. It is important to ask the parent permission to discuss potentially sensitive topics when the grandparent is present or ask for the grandparent to step out of the room.
Why not just be sure the grandmother stays in the waiting room? If the hurts from the past still are affecting the mother now, moderating an open conversation about those experiences can be very valuable to reducing their impact on present parenting or dysfunctional coping strategies.
Some experts say that any enumeration of ACEs should include asking “Which of these are still bothering you now?” Saying, “Parenting often brings up memories of similar situations from when we were young that can tilt how we act toward our own children,” then asking, “Can we talk about those experiences you had?”
Eliciting the grandparent’s perspective with a question such as “What were those years of parenting like for you?” respects the significance of the grandparent’s role. The grandparents probably were young, stressed, and inexperienced when they were the mother’s primary caregivers. Or the grandparent may have gratefully erased memories of the tough moments but the parent clearly remembers the childhood pain, because hurts sear themselves into our brains more than positive or neutral experiences do. She or he may have been holding resentment against the grandparent and living it out for years and now in her/his parenting.
Suddenly, you and the parent may hear the grandparent reveal other factors that would never have been visible to the child then and may never have been brought up because the grandparent was working three jobs because the father was deployed; caring for a sick sibling; suffering from depression; being subject to an abusive alcoholic spouse; having to keep the children inside because of shooting in the neighborhood, etc. You may be able reframe what is said to point out that the grandparents “did the best they could at the time and with the resources and skills they possessed then.”
Mothers who had troubled relationships with their own mothers (e.g. insecure attachment) tend to pass these patterns down in their own parenting unless they have processed the experiences and come to a place of acceptance. People may process their past effectively on their own, some through mental health counseling or religion, but for others a brief “Ah ha!” moment may help settle the waters.
Ask the grandparent as well as the parent, “What are you hoping will go differently than when [parent] was growing up?” Some try to make up for what they see as their own mistakes by advocating coming down harder on their grandchildren than they did on their own. An example among my patients was the grandmother whose daughter had become a heroin user, who was very strict and critical in her determination that her granddaughter would not fall into the wrong crowd. Voicing this for her as a possible reason for her strident posture dramatically shifted her attitude.
Other times parents, maybe grateful for a place to live with the grandparents but also trapped there financially, are simmering with anger at the grandparents’ intrusions into their parenting choices. It can be useful to point out that grandparents, no longer caught up in careers, may feel the need to be useful and have a role by giving advice or bustling around cleaning and buying things for their grandchildren. Hey, any help can be welcome if you don’t take it as meaning you are not doing a good job! Although limits can be set.
Transitioning to regarding one’s grown child as an adult and letting them make their own choices and mistakes, waiting until asked for advice, can take a lot of tongue biting after years of active parenting. One essay I read about an adult’s fond memories of his father included the realization that some of the best parenting he recalled was when his father left things unsaid.
Cultural differences in parenting between grandparent and parent can be another source of stress. Assimilation happens fast in America. The newest generation is often trying very hard NOT to be like the “old country.” The parents’ turning away from the grandparents’ culture or religion can threaten their values and culture for which they may have sacrificed everything. Advising the parent to celebrate at least some traditions may reduce the tension at little cost.
As of 2016, 5% of U.S. children in two-parent families lived with a grandparent and 15% of single parents do. This is much higher in certain ethnic groups where living with your adult children is expected. Even if not living together, their influence may be great. Many parents report more stress than support from grandparents. Negative mother-in-law stories abound! That is why simply asking if the parent “has anyone to help them” as a way of assessing social support can be very misleading. You also may ask “Is that more a help or a problem?”
When grandparents undermine the parents’ rules, of course, a family meeting is in order. But grandparents, with the wisdom of years and reduced life pressure, tend to care for children more generously and less critically than when they were main caregivers, conveying unconditional love that can buffer stresses and be remembered by the beloved child forever.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
One of the things that makes pediatrics challenging and potentially rewarding is that there are often multiple family members in the room for our visits.
With an expansion of our acknowledged role safeguarding and promoting a child’s current and future health to include asking about environmental and caregiving influences comes some tricky dynamics. The parent is in the room with a teen who has a secret love life. A father is in the room with the mother he threatens at home. The mother is in the room with the preschooler she has hit. There is risk but also opportunity for valuable discourse, discovery, and healing.
We now know that about 50% of the future morbidity of the child before us will be determined by the adverse childhood experiences (ACEs) they experience during the exact years (0-18) they are under our health supervision. Many of these risk factors come from home life and may be preventable or at least moderated. When we begin screening for ACEs we are asking the parents about bad things that happened when they were growing up.
The dilemma that came up recently was the grandmother in the room with the daughter she raised who is now caring for her own child. In this situation, you may be in the presence of the person whom the parent feels inflicted – or failed to prevent – the hurts being discussed.
“How are things at home?” you ask dutifully. Mother says “Fine,” but rolls her eyes. Grandma, sitting in the room looking at her phone, says something to the mother in a foreign language. You are in the dark, but sense friction.
Even in modern times, it is respectful to address the grandparent who is present first in a visit, introducing yourself, and finding out the relationship and living situation. Previsit questionnaires can help set visit priorities and alert you to what topics may be better discussed in private, perhaps including ACEs. It is important to ask the parent permission to discuss potentially sensitive topics when the grandparent is present or ask for the grandparent to step out of the room.
Why not just be sure the grandmother stays in the waiting room? If the hurts from the past still are affecting the mother now, moderating an open conversation about those experiences can be very valuable to reducing their impact on present parenting or dysfunctional coping strategies.
Some experts say that any enumeration of ACEs should include asking “Which of these are still bothering you now?” Saying, “Parenting often brings up memories of similar situations from when we were young that can tilt how we act toward our own children,” then asking, “Can we talk about those experiences you had?”
Eliciting the grandparent’s perspective with a question such as “What were those years of parenting like for you?” respects the significance of the grandparent’s role. The grandparents probably were young, stressed, and inexperienced when they were the mother’s primary caregivers. Or the grandparent may have gratefully erased memories of the tough moments but the parent clearly remembers the childhood pain, because hurts sear themselves into our brains more than positive or neutral experiences do. She or he may have been holding resentment against the grandparent and living it out for years and now in her/his parenting.
Suddenly, you and the parent may hear the grandparent reveal other factors that would never have been visible to the child then and may never have been brought up because the grandparent was working three jobs because the father was deployed; caring for a sick sibling; suffering from depression; being subject to an abusive alcoholic spouse; having to keep the children inside because of shooting in the neighborhood, etc. You may be able reframe what is said to point out that the grandparents “did the best they could at the time and with the resources and skills they possessed then.”
Mothers who had troubled relationships with their own mothers (e.g. insecure attachment) tend to pass these patterns down in their own parenting unless they have processed the experiences and come to a place of acceptance. People may process their past effectively on their own, some through mental health counseling or religion, but for others a brief “Ah ha!” moment may help settle the waters.
Ask the grandparent as well as the parent, “What are you hoping will go differently than when [parent] was growing up?” Some try to make up for what they see as their own mistakes by advocating coming down harder on their grandchildren than they did on their own. An example among my patients was the grandmother whose daughter had become a heroin user, who was very strict and critical in her determination that her granddaughter would not fall into the wrong crowd. Voicing this for her as a possible reason for her strident posture dramatically shifted her attitude.
Other times parents, maybe grateful for a place to live with the grandparents but also trapped there financially, are simmering with anger at the grandparents’ intrusions into their parenting choices. It can be useful to point out that grandparents, no longer caught up in careers, may feel the need to be useful and have a role by giving advice or bustling around cleaning and buying things for their grandchildren. Hey, any help can be welcome if you don’t take it as meaning you are not doing a good job! Although limits can be set.
Transitioning to regarding one’s grown child as an adult and letting them make their own choices and mistakes, waiting until asked for advice, can take a lot of tongue biting after years of active parenting. One essay I read about an adult’s fond memories of his father included the realization that some of the best parenting he recalled was when his father left things unsaid.
Cultural differences in parenting between grandparent and parent can be another source of stress. Assimilation happens fast in America. The newest generation is often trying very hard NOT to be like the “old country.” The parents’ turning away from the grandparents’ culture or religion can threaten their values and culture for which they may have sacrificed everything. Advising the parent to celebrate at least some traditions may reduce the tension at little cost.
As of 2016, 5% of U.S. children in two-parent families lived with a grandparent and 15% of single parents do. This is much higher in certain ethnic groups where living with your adult children is expected. Even if not living together, their influence may be great. Many parents report more stress than support from grandparents. Negative mother-in-law stories abound! That is why simply asking if the parent “has anyone to help them” as a way of assessing social support can be very misleading. You also may ask “Is that more a help or a problem?”
When grandparents undermine the parents’ rules, of course, a family meeting is in order. But grandparents, with the wisdom of years and reduced life pressure, tend to care for children more generously and less critically than when they were main caregivers, conveying unconditional love that can buffer stresses and be remembered by the beloved child forever.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Doctors concerned about recent immigration changes
New Trump administration regulations will make it more difficult for immigrants to remain in the United States if they receive health care assistance – in sharp contrasts to a recent movement in medicine to address the social determinants of health.
Under longstanding immigration policy, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge.
Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.
The new regulation, published Aug. 14 in the Federal Register, allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program (SNAP), and several housing programs. The final regulation continues to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.
The rule is not only unethical, but it will cause medical care to be unavailable to patients who are hardworking, have families to support, and often are employed in trades that are low-paying, said Alan R. Nelson, MD, an internist-endocrinologist and former special advisor to the CEO of the American College of Physicians.
“The rule not only flies in the face of efforts to confront social determinants of health and thereby reduce disparities in care and outcomes, but will strain emergency and safety net services at the local/county level and burden hospitals and clinics with more uncompensated care,” Dr. Nelson said in an interview. “Everybody loses.”
In a joint statement, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the ACP, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.
“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”
The change comes amid ongoing efforts among physicians and health care professionals to address health care disparities based on cultural differences and social factors. A number of medical schools, such as the University of Pennsylvania’s in Philadelphia, are enhancing their curriculum on social determinants of health to develop more sensitive and culturally competent physicians.
Meanwhile, the American Medical Association in April announced a collaboration with UnitedHealthcare that aims to address social and environmental factors that affect patients’ health by standardizing data collection of social determinants of health. The two groups support the creation of 23 new ICD-10 codes related to social determinants that would capture such factors as access to nutritious food, adequate and safe housing, available transportation, ability to pay for medications, and ability to pay for utilities.
William Golden, MD, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said there appears to be a growing disconnect between government policy and evolving trends in population health.
“There are public policy issues evolving that I think will put the health care profession at odds with some of the economic regulation being put in place,” said Dr. Golden. “I think people are increasingly realizing that to manage population health, you have to go beyond treating lab values and X-rays. Social environment is a big driver in people’s health status. It’s no surprise that people who have lower educational obtainment and who have more challenging financial situations are often in more challenged health status. Add that to people who are now potentially not having access to health coverage, and I think it’s a set up for creating a population that will present to our [emergency rooms] with significant acute care challenges.”
This article was updated 8/22/2019.
New Trump administration regulations will make it more difficult for immigrants to remain in the United States if they receive health care assistance – in sharp contrasts to a recent movement in medicine to address the social determinants of health.
Under longstanding immigration policy, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge.
Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.
The new regulation, published Aug. 14 in the Federal Register, allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program (SNAP), and several housing programs. The final regulation continues to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.
The rule is not only unethical, but it will cause medical care to be unavailable to patients who are hardworking, have families to support, and often are employed in trades that are low-paying, said Alan R. Nelson, MD, an internist-endocrinologist and former special advisor to the CEO of the American College of Physicians.
“The rule not only flies in the face of efforts to confront social determinants of health and thereby reduce disparities in care and outcomes, but will strain emergency and safety net services at the local/county level and burden hospitals and clinics with more uncompensated care,” Dr. Nelson said in an interview. “Everybody loses.”
In a joint statement, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the ACP, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.
“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”
The change comes amid ongoing efforts among physicians and health care professionals to address health care disparities based on cultural differences and social factors. A number of medical schools, such as the University of Pennsylvania’s in Philadelphia, are enhancing their curriculum on social determinants of health to develop more sensitive and culturally competent physicians.
Meanwhile, the American Medical Association in April announced a collaboration with UnitedHealthcare that aims to address social and environmental factors that affect patients’ health by standardizing data collection of social determinants of health. The two groups support the creation of 23 new ICD-10 codes related to social determinants that would capture such factors as access to nutritious food, adequate and safe housing, available transportation, ability to pay for medications, and ability to pay for utilities.
William Golden, MD, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said there appears to be a growing disconnect between government policy and evolving trends in population health.
“There are public policy issues evolving that I think will put the health care profession at odds with some of the economic regulation being put in place,” said Dr. Golden. “I think people are increasingly realizing that to manage population health, you have to go beyond treating lab values and X-rays. Social environment is a big driver in people’s health status. It’s no surprise that people who have lower educational obtainment and who have more challenging financial situations are often in more challenged health status. Add that to people who are now potentially not having access to health coverage, and I think it’s a set up for creating a population that will present to our [emergency rooms] with significant acute care challenges.”
This article was updated 8/22/2019.
New Trump administration regulations will make it more difficult for immigrants to remain in the United States if they receive health care assistance – in sharp contrasts to a recent movement in medicine to address the social determinants of health.
Under longstanding immigration policy, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge.
Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.
The new regulation, published Aug. 14 in the Federal Register, allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program (SNAP), and several housing programs. The final regulation continues to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.
The rule is not only unethical, but it will cause medical care to be unavailable to patients who are hardworking, have families to support, and often are employed in trades that are low-paying, said Alan R. Nelson, MD, an internist-endocrinologist and former special advisor to the CEO of the American College of Physicians.
“The rule not only flies in the face of efforts to confront social determinants of health and thereby reduce disparities in care and outcomes, but will strain emergency and safety net services at the local/county level and burden hospitals and clinics with more uncompensated care,” Dr. Nelson said in an interview. “Everybody loses.”
In a joint statement, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the ACP, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.
“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”
The change comes amid ongoing efforts among physicians and health care professionals to address health care disparities based on cultural differences and social factors. A number of medical schools, such as the University of Pennsylvania’s in Philadelphia, are enhancing their curriculum on social determinants of health to develop more sensitive and culturally competent physicians.
Meanwhile, the American Medical Association in April announced a collaboration with UnitedHealthcare that aims to address social and environmental factors that affect patients’ health by standardizing data collection of social determinants of health. The two groups support the creation of 23 new ICD-10 codes related to social determinants that would capture such factors as access to nutritious food, adequate and safe housing, available transportation, ability to pay for medications, and ability to pay for utilities.
William Golden, MD, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said there appears to be a growing disconnect between government policy and evolving trends in population health.
“There are public policy issues evolving that I think will put the health care profession at odds with some of the economic regulation being put in place,” said Dr. Golden. “I think people are increasingly realizing that to manage population health, you have to go beyond treating lab values and X-rays. Social environment is a big driver in people’s health status. It’s no surprise that people who have lower educational obtainment and who have more challenging financial situations are often in more challenged health status. Add that to people who are now potentially not having access to health coverage, and I think it’s a set up for creating a population that will present to our [emergency rooms] with significant acute care challenges.”
This article was updated 8/22/2019.
Chernobyl vodka, music-enhanced cheese, and bong bacteria
Cheers, comrades
In the eternal words of Dr. Ian Malcolm, “Your scientists were so preoccupied with whether or not they could, they didn’t stop to think if they should.” While he was talking about resurrecting dinosaurs, today we’re applying it to making Chernobyl vodka.
Excuse me? Yes, that’s right – an international team of scientists decided to combine the two most famous elements from the former U.S.S.R. As if taking shots isn’t hard enough, let’s make ’em radioactive.
The (potentially glowing) spirit was produced from rye grown in the exclusion zone, the area immediately surrounding the entombed power plant that was off limits to humans for decades. The (potentially drunk) research team decided to create their nuclear moonshine to show the now-tiny levels of radiation that live in soil and crops near Chernobyl today. After distilling the liquor, they reported there was no Chernobyl-related radioactivity in the bottle.
We want to believe them, but we don’t fancy sprouting a third hand after a night of partying. Perhaps it’s best to keep that one far, far back on the shelf.
Play that funky music, cheddar
It’s the most important experiment of all time: How does music affect cheese?
The vital research was conducted in Switzerland (but, in a surprising twist, not with Swiss cheese) and examined how the flavorful microorganisms in cheese react to sound waves. Nine wheels of Emmental were exposed to five different genres of music, including such hits as Led Zeppelin’s “Stairway to Heaven,” “Jazz (We’ve Got)” by A Tribe Called Quest, and Mozart’s “The Magic Flute.”
After 6 months of music exposure, food technologists then taste-tested the cheese (we’re sending our resumes in immediately for this job) and found that the cheeses that listened to music were overall more mild than the control cheese, which sadly was given no music at all.
A panel of Swiss chefs also conducted a blind taste of the various cheeses, and overwhelmingly agreed that the cheeses that listened to hip-hop music were better than the rest.
Hosting a dinner party soon? Drag that wheel of Brie out of the fridge and play it some Jay-Z. Your guests will thank you.
Dude, where’s my disinfectant?
What’s the dirtiest, most bacteria-covered thing you can think of? Dog’s food bowl? Dumpster? Public toilet seat?
Think again.
Our friends at Moose Labs, maker of the MouthPeace (“Providing excellent germ protection when sharing bongs”) and other fine smoking products, decided to take a break from their extensive product testing and do some science instead.
They used a Hygiena Luminometer in conjunction with adenosine triphosphate swabs to determine the bacterial contamination of cannabis pipes and some other, more mundane surfaces, which produced a measurement in relative light units (RLUs). A pipe was provided to participants at two social consumption cannabis events in California and then swabbed several times through 100 uses.
Additional swabbing took place at a number of real-world locations, and as the company noted, “it was difficult to find a neutral object in daily life that was as contaminated as a cannabis pipe.”
Before we look at the data, here’s an observation: There is one object on the list that people put their mouths on (we hope) and one that dogs put their mouths on.
And now, some average bacterial measurements:
- Dog food bowls: 248.5 RLU.
- ATM keypad buttons: 1,819 RLU.
- Public toilet seats: 2,350 RLU.
- Cannabis pipes: 3,497 RLU.
When reached for comment, a bacterium inhabiting a cannabis pipe had this to say: “It’s like the big book says, dude: Be totally excellent and multiply.”
You may want to skip that morning coffee
It’s no secret that Earth’s climate is changing. The planet is heating up as record amounts of carbon dioxide and other greenhouse gases are pumped into the atmosphere every year. It’s a complex and dire problem with no easy solution.
Well, unless you’re Jair Bolsonaro, president of Brazil. He’s come up with a very simple, very elegant way to save the environment: Poop less.
To be more precise, pooping every other day “will be better for the whole world,” according to Mr. Bolsonaro. His statement, made in response to criticism that clear-cutting of the Brazilian rainforest has accelerated dramatically in the past year (870 square miles in July 2019, a 278% increase from the year before), also included a call to eat less, which is fair enough. As for the poop advice, we run into a slight problem.
According to a 2018 study published in the American Journal of Gastroenterology, healthy adults poop anywhere from three times a day (the Taco Bell enthusiasts, no doubt) to three times a week, and only 40% poop at least once a day. A “poop every other day” law would likely result only in a lot of brown pants and not a lot of healthier environment.
So, back to the drawing board, we’re afraid. Maybe nix that whole clear-cutting the rainforest thing?
Cheers, comrades
In the eternal words of Dr. Ian Malcolm, “Your scientists were so preoccupied with whether or not they could, they didn’t stop to think if they should.” While he was talking about resurrecting dinosaurs, today we’re applying it to making Chernobyl vodka.
Excuse me? Yes, that’s right – an international team of scientists decided to combine the two most famous elements from the former U.S.S.R. As if taking shots isn’t hard enough, let’s make ’em radioactive.
The (potentially glowing) spirit was produced from rye grown in the exclusion zone, the area immediately surrounding the entombed power plant that was off limits to humans for decades. The (potentially drunk) research team decided to create their nuclear moonshine to show the now-tiny levels of radiation that live in soil and crops near Chernobyl today. After distilling the liquor, they reported there was no Chernobyl-related radioactivity in the bottle.
We want to believe them, but we don’t fancy sprouting a third hand after a night of partying. Perhaps it’s best to keep that one far, far back on the shelf.
Play that funky music, cheddar
It’s the most important experiment of all time: How does music affect cheese?
The vital research was conducted in Switzerland (but, in a surprising twist, not with Swiss cheese) and examined how the flavorful microorganisms in cheese react to sound waves. Nine wheels of Emmental were exposed to five different genres of music, including such hits as Led Zeppelin’s “Stairway to Heaven,” “Jazz (We’ve Got)” by A Tribe Called Quest, and Mozart’s “The Magic Flute.”
After 6 months of music exposure, food technologists then taste-tested the cheese (we’re sending our resumes in immediately for this job) and found that the cheeses that listened to music were overall more mild than the control cheese, which sadly was given no music at all.
A panel of Swiss chefs also conducted a blind taste of the various cheeses, and overwhelmingly agreed that the cheeses that listened to hip-hop music were better than the rest.
Hosting a dinner party soon? Drag that wheel of Brie out of the fridge and play it some Jay-Z. Your guests will thank you.
Dude, where’s my disinfectant?
What’s the dirtiest, most bacteria-covered thing you can think of? Dog’s food bowl? Dumpster? Public toilet seat?
Think again.
Our friends at Moose Labs, maker of the MouthPeace (“Providing excellent germ protection when sharing bongs”) and other fine smoking products, decided to take a break from their extensive product testing and do some science instead.
They used a Hygiena Luminometer in conjunction with adenosine triphosphate swabs to determine the bacterial contamination of cannabis pipes and some other, more mundane surfaces, which produced a measurement in relative light units (RLUs). A pipe was provided to participants at two social consumption cannabis events in California and then swabbed several times through 100 uses.
Additional swabbing took place at a number of real-world locations, and as the company noted, “it was difficult to find a neutral object in daily life that was as contaminated as a cannabis pipe.”
Before we look at the data, here’s an observation: There is one object on the list that people put their mouths on (we hope) and one that dogs put their mouths on.
And now, some average bacterial measurements:
- Dog food bowls: 248.5 RLU.
- ATM keypad buttons: 1,819 RLU.
- Public toilet seats: 2,350 RLU.
- Cannabis pipes: 3,497 RLU.
When reached for comment, a bacterium inhabiting a cannabis pipe had this to say: “It’s like the big book says, dude: Be totally excellent and multiply.”
You may want to skip that morning coffee
It’s no secret that Earth’s climate is changing. The planet is heating up as record amounts of carbon dioxide and other greenhouse gases are pumped into the atmosphere every year. It’s a complex and dire problem with no easy solution.
Well, unless you’re Jair Bolsonaro, president of Brazil. He’s come up with a very simple, very elegant way to save the environment: Poop less.
To be more precise, pooping every other day “will be better for the whole world,” according to Mr. Bolsonaro. His statement, made in response to criticism that clear-cutting of the Brazilian rainforest has accelerated dramatically in the past year (870 square miles in July 2019, a 278% increase from the year before), also included a call to eat less, which is fair enough. As for the poop advice, we run into a slight problem.
According to a 2018 study published in the American Journal of Gastroenterology, healthy adults poop anywhere from three times a day (the Taco Bell enthusiasts, no doubt) to three times a week, and only 40% poop at least once a day. A “poop every other day” law would likely result only in a lot of brown pants and not a lot of healthier environment.
So, back to the drawing board, we’re afraid. Maybe nix that whole clear-cutting the rainforest thing?
Cheers, comrades
In the eternal words of Dr. Ian Malcolm, “Your scientists were so preoccupied with whether or not they could, they didn’t stop to think if they should.” While he was talking about resurrecting dinosaurs, today we’re applying it to making Chernobyl vodka.
Excuse me? Yes, that’s right – an international team of scientists decided to combine the two most famous elements from the former U.S.S.R. As if taking shots isn’t hard enough, let’s make ’em radioactive.
The (potentially glowing) spirit was produced from rye grown in the exclusion zone, the area immediately surrounding the entombed power plant that was off limits to humans for decades. The (potentially drunk) research team decided to create their nuclear moonshine to show the now-tiny levels of radiation that live in soil and crops near Chernobyl today. After distilling the liquor, they reported there was no Chernobyl-related radioactivity in the bottle.
We want to believe them, but we don’t fancy sprouting a third hand after a night of partying. Perhaps it’s best to keep that one far, far back on the shelf.
Play that funky music, cheddar
It’s the most important experiment of all time: How does music affect cheese?
The vital research was conducted in Switzerland (but, in a surprising twist, not with Swiss cheese) and examined how the flavorful microorganisms in cheese react to sound waves. Nine wheels of Emmental were exposed to five different genres of music, including such hits as Led Zeppelin’s “Stairway to Heaven,” “Jazz (We’ve Got)” by A Tribe Called Quest, and Mozart’s “The Magic Flute.”
After 6 months of music exposure, food technologists then taste-tested the cheese (we’re sending our resumes in immediately for this job) and found that the cheeses that listened to music were overall more mild than the control cheese, which sadly was given no music at all.
A panel of Swiss chefs also conducted a blind taste of the various cheeses, and overwhelmingly agreed that the cheeses that listened to hip-hop music were better than the rest.
Hosting a dinner party soon? Drag that wheel of Brie out of the fridge and play it some Jay-Z. Your guests will thank you.
Dude, where’s my disinfectant?
What’s the dirtiest, most bacteria-covered thing you can think of? Dog’s food bowl? Dumpster? Public toilet seat?
Think again.
Our friends at Moose Labs, maker of the MouthPeace (“Providing excellent germ protection when sharing bongs”) and other fine smoking products, decided to take a break from their extensive product testing and do some science instead.
They used a Hygiena Luminometer in conjunction with adenosine triphosphate swabs to determine the bacterial contamination of cannabis pipes and some other, more mundane surfaces, which produced a measurement in relative light units (RLUs). A pipe was provided to participants at two social consumption cannabis events in California and then swabbed several times through 100 uses.
Additional swabbing took place at a number of real-world locations, and as the company noted, “it was difficult to find a neutral object in daily life that was as contaminated as a cannabis pipe.”
Before we look at the data, here’s an observation: There is one object on the list that people put their mouths on (we hope) and one that dogs put their mouths on.
And now, some average bacterial measurements:
- Dog food bowls: 248.5 RLU.
- ATM keypad buttons: 1,819 RLU.
- Public toilet seats: 2,350 RLU.
- Cannabis pipes: 3,497 RLU.
When reached for comment, a bacterium inhabiting a cannabis pipe had this to say: “It’s like the big book says, dude: Be totally excellent and multiply.”
You may want to skip that morning coffee
It’s no secret that Earth’s climate is changing. The planet is heating up as record amounts of carbon dioxide and other greenhouse gases are pumped into the atmosphere every year. It’s a complex and dire problem with no easy solution.
Well, unless you’re Jair Bolsonaro, president of Brazil. He’s come up with a very simple, very elegant way to save the environment: Poop less.
To be more precise, pooping every other day “will be better for the whole world,” according to Mr. Bolsonaro. His statement, made in response to criticism that clear-cutting of the Brazilian rainforest has accelerated dramatically in the past year (870 square miles in July 2019, a 278% increase from the year before), also included a call to eat less, which is fair enough. As for the poop advice, we run into a slight problem.
According to a 2018 study published in the American Journal of Gastroenterology, healthy adults poop anywhere from three times a day (the Taco Bell enthusiasts, no doubt) to three times a week, and only 40% poop at least once a day. A “poop every other day” law would likely result only in a lot of brown pants and not a lot of healthier environment.
So, back to the drawing board, we’re afraid. Maybe nix that whole clear-cutting the rainforest thing?
CDC updates recommendation for serologic Lyme disease detection
, according to CDC investigators.
At the 1994 Second National Conference on Serologic Diagnosis of Lyme Disease, several groups and organizations convened, recommending a two-test methodology for Lyme disease detection. First, an enzyme immunoassay (EIA) or immunofluorescence assay should be used, followed by a western immunoblot assay for specimens yielding positive or equivocal results. The guideline advised that all future tests should be evaluated against a challenge panel, and that new assays should only move forward if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure.
On July 29, 2019, the Food and Drug Administration approved several Lyme disease serologic assays with new indications for use based on a modified two-test methodology, with a second EIA replacing the western immunoblot assay.
“Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is ‘substantially equivalent to or better than’ a legally marketed predicate test,” the CDC investigators noted (MMWR Morb Mortal Wkly Rep. 2019 Aug 15;68(32):703).
The recommendation advises that FDA-cleared “serologic assays that utilize EIA rather than western immunoblot assay in a two-test format are acceptable alternatives for the laboratory diagnosis of Lyme disease.”
, according to CDC investigators.
At the 1994 Second National Conference on Serologic Diagnosis of Lyme Disease, several groups and organizations convened, recommending a two-test methodology for Lyme disease detection. First, an enzyme immunoassay (EIA) or immunofluorescence assay should be used, followed by a western immunoblot assay for specimens yielding positive or equivocal results. The guideline advised that all future tests should be evaluated against a challenge panel, and that new assays should only move forward if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure.
On July 29, 2019, the Food and Drug Administration approved several Lyme disease serologic assays with new indications for use based on a modified two-test methodology, with a second EIA replacing the western immunoblot assay.
“Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is ‘substantially equivalent to or better than’ a legally marketed predicate test,” the CDC investigators noted (MMWR Morb Mortal Wkly Rep. 2019 Aug 15;68(32):703).
The recommendation advises that FDA-cleared “serologic assays that utilize EIA rather than western immunoblot assay in a two-test format are acceptable alternatives for the laboratory diagnosis of Lyme disease.”
, according to CDC investigators.
At the 1994 Second National Conference on Serologic Diagnosis of Lyme Disease, several groups and organizations convened, recommending a two-test methodology for Lyme disease detection. First, an enzyme immunoassay (EIA) or immunofluorescence assay should be used, followed by a western immunoblot assay for specimens yielding positive or equivocal results. The guideline advised that all future tests should be evaluated against a challenge panel, and that new assays should only move forward if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure.
On July 29, 2019, the Food and Drug Administration approved several Lyme disease serologic assays with new indications for use based on a modified two-test methodology, with a second EIA replacing the western immunoblot assay.
“Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is ‘substantially equivalent to or better than’ a legally marketed predicate test,” the CDC investigators noted (MMWR Morb Mortal Wkly Rep. 2019 Aug 15;68(32):703).
The recommendation advises that FDA-cleared “serologic assays that utilize EIA rather than western immunoblot assay in a two-test format are acceptable alternatives for the laboratory diagnosis of Lyme disease.”
FROM THE MMWR
How to nearly eliminate CLABSIs in children’s hospitals
SEATTLE – Levine Children’s Hospital, in Charlotte, N.C., dropped its central line–associated bloodstream infection rate from 1.13 per 1,000 line days to 0.67 in just a few months, with a mix of common sense steps and public accountability.
Levine Children’s was at about the 50th percentile for CLABSIs, compared with other children’s hospitals, but dropped to the 10th percentile after the changes. There were 21 CLABSIs in 2017, but only 12 in 2018. The hospital went 6 straight months without a CLABSI after the changes were made. The efforts saved about $300,000 and 63 patient days.
“We really had great success,” said Kayla S. Koch, MD, a pediatric hospitalist at Levine Children’s, who presented the findings at Pediatric Hospital Medicine.
Hospital units had been working to reduce CLABSIs, but they were each doing their own thing. “Many of our units were already dabbling, so we just sort of brought them together. We standardized the process and got everyone on the same page,” said copresenter Ketan P. Nadkarni, MD, also a pediatric hospitalist at Levine Children’s.
It wasn’t hard to get buy-in. “I don’t think the units were aware that everyone was doing it differently,” and were on board once the problem was explained. Also, using the same approach throughout the hospital made it easier for nurses and physicians moving between units, he said.
Each morning, the nurse supervisor and patient nurse would partner up at the bedside to check that central venous lines were set up correctly. They examined the alcohol disinfectant caps to make sure they were clean; determined that children were getting chlorhexidine gluconate baths; checked the dressings for bleeding and soiling; noted in the electronic medical record why the patient had a central line; and discussed with hospitalists if it were still needed. Problems were addressed immediately.
These quality processes were all tracked on wall racks placed in plain sight on each unit, including the neonatal and pediatric ICUs. Each central line patient had a card that listed what needed to be done, with a green stripe on one side and a red stripe on the other. If everything was done right, the green side faced out; if even one thing was done wrong, the red side was displayed, for all to see. It brought accountability to the process, the presenters said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The wall rack also had the central line audit schedule, plus diagrams that showed every failed item, the reason for it, and the unit’s compliance rate. Anyone walking by could see at a glance how the unit was doing that day and overall.
The number of dressing options was reduced from 10 to 2, a SorbaView SHIELD and a Tegaderm-like dressing, which made it easier to standardize the efforts. A protocol also was put in place to reinforce oozing dressings, instead of automatically changing them. “We were doing too many changes,” Dr. Koch said.
Compliance with the bundle was almost 90%. Staff “really got into it, and it was great to see,” she said.
The “initial success was almost unexpected, and so dramatic.” The goal now is to sustain the improvements, and roll them out to radiology and other places were central lines are placed, Dr. Nadkarni said.
There was no external funding, and the investigators had no disclosures.
SEATTLE – Levine Children’s Hospital, in Charlotte, N.C., dropped its central line–associated bloodstream infection rate from 1.13 per 1,000 line days to 0.67 in just a few months, with a mix of common sense steps and public accountability.
Levine Children’s was at about the 50th percentile for CLABSIs, compared with other children’s hospitals, but dropped to the 10th percentile after the changes. There were 21 CLABSIs in 2017, but only 12 in 2018. The hospital went 6 straight months without a CLABSI after the changes were made. The efforts saved about $300,000 and 63 patient days.
“We really had great success,” said Kayla S. Koch, MD, a pediatric hospitalist at Levine Children’s, who presented the findings at Pediatric Hospital Medicine.
Hospital units had been working to reduce CLABSIs, but they were each doing their own thing. “Many of our units were already dabbling, so we just sort of brought them together. We standardized the process and got everyone on the same page,” said copresenter Ketan P. Nadkarni, MD, also a pediatric hospitalist at Levine Children’s.
It wasn’t hard to get buy-in. “I don’t think the units were aware that everyone was doing it differently,” and were on board once the problem was explained. Also, using the same approach throughout the hospital made it easier for nurses and physicians moving between units, he said.
Each morning, the nurse supervisor and patient nurse would partner up at the bedside to check that central venous lines were set up correctly. They examined the alcohol disinfectant caps to make sure they were clean; determined that children were getting chlorhexidine gluconate baths; checked the dressings for bleeding and soiling; noted in the electronic medical record why the patient had a central line; and discussed with hospitalists if it were still needed. Problems were addressed immediately.
These quality processes were all tracked on wall racks placed in plain sight on each unit, including the neonatal and pediatric ICUs. Each central line patient had a card that listed what needed to be done, with a green stripe on one side and a red stripe on the other. If everything was done right, the green side faced out; if even one thing was done wrong, the red side was displayed, for all to see. It brought accountability to the process, the presenters said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The wall rack also had the central line audit schedule, plus diagrams that showed every failed item, the reason for it, and the unit’s compliance rate. Anyone walking by could see at a glance how the unit was doing that day and overall.
The number of dressing options was reduced from 10 to 2, a SorbaView SHIELD and a Tegaderm-like dressing, which made it easier to standardize the efforts. A protocol also was put in place to reinforce oozing dressings, instead of automatically changing them. “We were doing too many changes,” Dr. Koch said.
Compliance with the bundle was almost 90%. Staff “really got into it, and it was great to see,” she said.
The “initial success was almost unexpected, and so dramatic.” The goal now is to sustain the improvements, and roll them out to radiology and other places were central lines are placed, Dr. Nadkarni said.
There was no external funding, and the investigators had no disclosures.
SEATTLE – Levine Children’s Hospital, in Charlotte, N.C., dropped its central line–associated bloodstream infection rate from 1.13 per 1,000 line days to 0.67 in just a few months, with a mix of common sense steps and public accountability.
Levine Children’s was at about the 50th percentile for CLABSIs, compared with other children’s hospitals, but dropped to the 10th percentile after the changes. There were 21 CLABSIs in 2017, but only 12 in 2018. The hospital went 6 straight months without a CLABSI after the changes were made. The efforts saved about $300,000 and 63 patient days.
“We really had great success,” said Kayla S. Koch, MD, a pediatric hospitalist at Levine Children’s, who presented the findings at Pediatric Hospital Medicine.
Hospital units had been working to reduce CLABSIs, but they were each doing their own thing. “Many of our units were already dabbling, so we just sort of brought them together. We standardized the process and got everyone on the same page,” said copresenter Ketan P. Nadkarni, MD, also a pediatric hospitalist at Levine Children’s.
It wasn’t hard to get buy-in. “I don’t think the units were aware that everyone was doing it differently,” and were on board once the problem was explained. Also, using the same approach throughout the hospital made it easier for nurses and physicians moving between units, he said.
Each morning, the nurse supervisor and patient nurse would partner up at the bedside to check that central venous lines were set up correctly. They examined the alcohol disinfectant caps to make sure they were clean; determined that children were getting chlorhexidine gluconate baths; checked the dressings for bleeding and soiling; noted in the electronic medical record why the patient had a central line; and discussed with hospitalists if it were still needed. Problems were addressed immediately.
These quality processes were all tracked on wall racks placed in plain sight on each unit, including the neonatal and pediatric ICUs. Each central line patient had a card that listed what needed to be done, with a green stripe on one side and a red stripe on the other. If everything was done right, the green side faced out; if even one thing was done wrong, the red side was displayed, for all to see. It brought accountability to the process, the presenters said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The wall rack also had the central line audit schedule, plus diagrams that showed every failed item, the reason for it, and the unit’s compliance rate. Anyone walking by could see at a glance how the unit was doing that day and overall.
The number of dressing options was reduced from 10 to 2, a SorbaView SHIELD and a Tegaderm-like dressing, which made it easier to standardize the efforts. A protocol also was put in place to reinforce oozing dressings, instead of automatically changing them. “We were doing too many changes,” Dr. Koch said.
Compliance with the bundle was almost 90%. Staff “really got into it, and it was great to see,” she said.
The “initial success was almost unexpected, and so dramatic.” The goal now is to sustain the improvements, and roll them out to radiology and other places were central lines are placed, Dr. Nadkarni said.
There was no external funding, and the investigators had no disclosures.
REPORTING FROM PHM 2019
Recalling a medical education
As I look back, there have been many changes during my 25 years of clinical practice. I always assumed there would be advancements in medical research during my career. I expected those advancements to produce progress rather than a random walk.
One area of positive change has been the recommendations for safe sleep practices for young infants. The Back to Sleep program of the mid 1990s reversed prior advice. It recommended that babies should sleep on their backs to avoid accidental suffocation. Prior advice had been that they should sleep on their stomachs to avoid aspiration. The new advice cut infant deaths by 50%.
Over the years, treatment of gastroesophageal reflux has significantly changed. Polysomnograms are ordered much less frequently. Medications to reduce stomach acid have been associated with side effects and now are discouraged. Raising the head of the crib was common advice in 2000s that was contradicted in the 2010s. For 2 decades I wrote orders in the hospital to elevate the head of the crib. More frequently, the nurses did it without my orders whenever they found a spitty baby.
In May 2019, there was a product recall of inclined infant sleepers. The Fisher-Price Rock ‘n Play was one product recalled; 4.7 million of these were sold in the United States in the past 10 years. Because they are used only by infants, and because there are about 4 million births per year in the United States, there are enough of these items stored in basements and garages for every infant to have one.
Investigative reporting by the Washington Post yielded an article highly critical of the product and the way it was originally created and designed. There is outrage in the author’s description of events. Because I have degrees in both engineering and pediatric medicine, I reviewed his assertions and tried to compare his ideal of the medical research world with my reality.
There are 3,600 infant deaths per year in the United States attributed to SUID/SIDS (sudden unexplained infant death/sudden infant death syndrome). From that perspective, I don’t know what 30 deaths in a decade associated with the sleeper really means. There is a high potential for recall bias and confirmation bias. It doesn’t surprise me that there was a delay in assigning blame to an ubiquitous consumer product. The article assumes that medical opinion is monolithic and synchronized rather than undergoing a diffusion of innovation, as described by Everett M. Rogers. Sorting out who knew what and when they knew it will take the courts many years.
Some of my columns earlier this year have appraised medical information in social media, and particularly on Facebook, as being harmfully unreliable.
An example of the unreliability of modern medical research was documented in an article in Hospital Pediatrics in July 2019.
The authors were performing a meta-analysis to determine whether the use of respiratory viral (RV) detection tests are helpful in reducing length of stay or reducing unnecessary antibiotic use. To me, that is a much simpler issue, scientifically, than safe sleep practices. The authors found 23 relevant studies that met their criteria for inclusion. Their overall conclusion was that the quality of the studies, the heterogeneity of the studies, and the statistically significant but contradictory results between the studies made it impossible to prove RV testing is beneficial. However, as I read the article, they cannot – for a litany of reasons – rule out such a benefit. Twenty three published articles in total yielded no reliable medical knowledge.
RV testing already has been widely adopted, particularly in emergency rooms. It is expensive. Clinical guidelines discourage RV testing but those guidelines are based on RV testing in the 2003-2006 time frame, which is obsolete technology. The author of the article on the infant sleepers expressed shock at what he considered to be inadequate medical research supporting the development of the inclined infant sleeper. RV testing is a product in widespread use, with lots of research, and has no better proof of efficacy or safety.
I expected, when I first started practice, that when I was older and grayer I would look back and recall many advances. I anticipated my recall would be of fond memories and of many patients helped. What I didn’t expect was so much of the advice that I provided to be wrong. Perhaps my medical education and parts of the academic research system should be subject to a product recall.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
As I look back, there have been many changes during my 25 years of clinical practice. I always assumed there would be advancements in medical research during my career. I expected those advancements to produce progress rather than a random walk.
One area of positive change has been the recommendations for safe sleep practices for young infants. The Back to Sleep program of the mid 1990s reversed prior advice. It recommended that babies should sleep on their backs to avoid accidental suffocation. Prior advice had been that they should sleep on their stomachs to avoid aspiration. The new advice cut infant deaths by 50%.
Over the years, treatment of gastroesophageal reflux has significantly changed. Polysomnograms are ordered much less frequently. Medications to reduce stomach acid have been associated with side effects and now are discouraged. Raising the head of the crib was common advice in 2000s that was contradicted in the 2010s. For 2 decades I wrote orders in the hospital to elevate the head of the crib. More frequently, the nurses did it without my orders whenever they found a spitty baby.
In May 2019, there was a product recall of inclined infant sleepers. The Fisher-Price Rock ‘n Play was one product recalled; 4.7 million of these were sold in the United States in the past 10 years. Because they are used only by infants, and because there are about 4 million births per year in the United States, there are enough of these items stored in basements and garages for every infant to have one.
Investigative reporting by the Washington Post yielded an article highly critical of the product and the way it was originally created and designed. There is outrage in the author’s description of events. Because I have degrees in both engineering and pediatric medicine, I reviewed his assertions and tried to compare his ideal of the medical research world with my reality.
There are 3,600 infant deaths per year in the United States attributed to SUID/SIDS (sudden unexplained infant death/sudden infant death syndrome). From that perspective, I don’t know what 30 deaths in a decade associated with the sleeper really means. There is a high potential for recall bias and confirmation bias. It doesn’t surprise me that there was a delay in assigning blame to an ubiquitous consumer product. The article assumes that medical opinion is monolithic and synchronized rather than undergoing a diffusion of innovation, as described by Everett M. Rogers. Sorting out who knew what and when they knew it will take the courts many years.
Some of my columns earlier this year have appraised medical information in social media, and particularly on Facebook, as being harmfully unreliable.
An example of the unreliability of modern medical research was documented in an article in Hospital Pediatrics in July 2019.
The authors were performing a meta-analysis to determine whether the use of respiratory viral (RV) detection tests are helpful in reducing length of stay or reducing unnecessary antibiotic use. To me, that is a much simpler issue, scientifically, than safe sleep practices. The authors found 23 relevant studies that met their criteria for inclusion. Their overall conclusion was that the quality of the studies, the heterogeneity of the studies, and the statistically significant but contradictory results between the studies made it impossible to prove RV testing is beneficial. However, as I read the article, they cannot – for a litany of reasons – rule out such a benefit. Twenty three published articles in total yielded no reliable medical knowledge.
RV testing already has been widely adopted, particularly in emergency rooms. It is expensive. Clinical guidelines discourage RV testing but those guidelines are based on RV testing in the 2003-2006 time frame, which is obsolete technology. The author of the article on the infant sleepers expressed shock at what he considered to be inadequate medical research supporting the development of the inclined infant sleeper. RV testing is a product in widespread use, with lots of research, and has no better proof of efficacy or safety.
I expected, when I first started practice, that when I was older and grayer I would look back and recall many advances. I anticipated my recall would be of fond memories and of many patients helped. What I didn’t expect was so much of the advice that I provided to be wrong. Perhaps my medical education and parts of the academic research system should be subject to a product recall.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
As I look back, there have been many changes during my 25 years of clinical practice. I always assumed there would be advancements in medical research during my career. I expected those advancements to produce progress rather than a random walk.
One area of positive change has been the recommendations for safe sleep practices for young infants. The Back to Sleep program of the mid 1990s reversed prior advice. It recommended that babies should sleep on their backs to avoid accidental suffocation. Prior advice had been that they should sleep on their stomachs to avoid aspiration. The new advice cut infant deaths by 50%.
Over the years, treatment of gastroesophageal reflux has significantly changed. Polysomnograms are ordered much less frequently. Medications to reduce stomach acid have been associated with side effects and now are discouraged. Raising the head of the crib was common advice in 2000s that was contradicted in the 2010s. For 2 decades I wrote orders in the hospital to elevate the head of the crib. More frequently, the nurses did it without my orders whenever they found a spitty baby.
In May 2019, there was a product recall of inclined infant sleepers. The Fisher-Price Rock ‘n Play was one product recalled; 4.7 million of these were sold in the United States in the past 10 years. Because they are used only by infants, and because there are about 4 million births per year in the United States, there are enough of these items stored in basements and garages for every infant to have one.
Investigative reporting by the Washington Post yielded an article highly critical of the product and the way it was originally created and designed. There is outrage in the author’s description of events. Because I have degrees in both engineering and pediatric medicine, I reviewed his assertions and tried to compare his ideal of the medical research world with my reality.
There are 3,600 infant deaths per year in the United States attributed to SUID/SIDS (sudden unexplained infant death/sudden infant death syndrome). From that perspective, I don’t know what 30 deaths in a decade associated with the sleeper really means. There is a high potential for recall bias and confirmation bias. It doesn’t surprise me that there was a delay in assigning blame to an ubiquitous consumer product. The article assumes that medical opinion is monolithic and synchronized rather than undergoing a diffusion of innovation, as described by Everett M. Rogers. Sorting out who knew what and when they knew it will take the courts many years.
Some of my columns earlier this year have appraised medical information in social media, and particularly on Facebook, as being harmfully unreliable.
An example of the unreliability of modern medical research was documented in an article in Hospital Pediatrics in July 2019.
The authors were performing a meta-analysis to determine whether the use of respiratory viral (RV) detection tests are helpful in reducing length of stay or reducing unnecessary antibiotic use. To me, that is a much simpler issue, scientifically, than safe sleep practices. The authors found 23 relevant studies that met their criteria for inclusion. Their overall conclusion was that the quality of the studies, the heterogeneity of the studies, and the statistically significant but contradictory results between the studies made it impossible to prove RV testing is beneficial. However, as I read the article, they cannot – for a litany of reasons – rule out such a benefit. Twenty three published articles in total yielded no reliable medical knowledge.
RV testing already has been widely adopted, particularly in emergency rooms. It is expensive. Clinical guidelines discourage RV testing but those guidelines are based on RV testing in the 2003-2006 time frame, which is obsolete technology. The author of the article on the infant sleepers expressed shock at what he considered to be inadequate medical research supporting the development of the inclined infant sleeper. RV testing is a product in widespread use, with lots of research, and has no better proof of efficacy or safety.
I expected, when I first started practice, that when I was older and grayer I would look back and recall many advances. I anticipated my recall would be of fond memories and of many patients helped. What I didn’t expect was so much of the advice that I provided to be wrong. Perhaps my medical education and parts of the academic research system should be subject to a product recall.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Regulations and the death of common sense
I jumped in the cab and told the driver to take me straight to hell. “Oh,” he said. “You mean LaGuardia?” He was correct, of course.
It takes me just as long to get to LaGuardia from a hotel in midtown Manhattan as it does for me to fly from Cincinnati to New York. And once you are at the airport, it’s a hot mess. I hear that the terminal update at LaGuardia will be finished in 4 years. This is going to cost $8 billion, plus another $2 billion for an elevated train that connects to the railroad and subway.
Cincinnati built itself a streetcar to nowhere after the city council made a field trip to Portlandia. It was fueled by $45 million in federal “stimulus” grants, disrupted downtown for 9 years instead of 3, and cost $145 million instead of $110.
No one rides the streetcar. It is regularly delayed by people parking on the tracks, and collisions with cars happen regularly. In fact, checking to see if anyone buys a ticket was determined to not be cost effective. The city government cannot close the streetcar for 20 years because the city would otherwise have to give back the $45 million grant used to build it.
How do such boondoggles happen? It was all explained in a book given to me by a new friend in New York. “The Death of Common Sense,” by Philip K. Howard, spells it out.
If you want to fix a problem in any city you must run a gauntlet of meetings and meet regulations, many of which have nothing to do with engineering, quality, or safety. Expect action or approval to take years.
The “you can’t be too careful” movement has assumed a life of its own.
Of course, the same process is true in medicine, only more so! Human lives are at stake, so absolutely no chances can be taken. Medicine is not engineering. And the science of medicine is often so inexact that no one knows when they are taking a chance, or what is the right or wrong thing to do. The paperwork and rules become enormous. The regulations proliferate.
The resulting health care administration costs account for about 25% of health care dollars.
In one recent “you can’t be too careful” moment, I had a Joint Commission inspector tell me he was concerned about patients falling off our power tables when we perform procedures under local anesthesia. Now this has never happened in the last 30 years, but you can’t be too careful! I jokingly suggested we consider giant Velcro straps for the tables, and added that they would be particularly useful for the front office staff chairs. The inspector got excited. He thought giant Velcro straps were a great idea. I am now searching online for giant Velcro straps.
Several years ago, I had a clinical lab improvement inspection and everything was perfect. The inspectors could not find anything wrong, but they had allocated a half day for the inspection. They cast about, and finally insisted I buy a red stamper to indicate on the Mohs maps that the case was clear. I pointed out that a straight line though the map indicated the same thing, and even showed them the colored key codes on the back. No, we must have a red stamp! Now we stamp all the maps, sometimes several times! You can’t be too careful! To head off our next “what can we find” moment, we make sure we leave an expired bottle of stain or tissue dye in the back of the cabinet for the inspectors to find.
Pathologists are expected to report melanomas to the state, but we found out that they were behind in their reporting. So we thought we might help them out with the reporting. What were we thinking!? Upon investigation we obtained an online form that is almost incomprehensible and takes at least an hour to fill out. The form must be submitted online and completed in its entirety. There is a 4-hour webinar to help teach you how to fill it out. I called the state health department to ask for help, I was directed to the webinar, and was told in no uncertain terms that it is serious crime not to report melanoma. Thanks! I will be sure to tell the pathologist.
So avoid LaGuardia Airport for at least 4 more years, come ride the Cincinnati streetcar where you really don’t need a ticket, always leave something small for the inspector to find (mum’s the word), and let me know if you find any giant Velcro straps for sale online!
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].
I jumped in the cab and told the driver to take me straight to hell. “Oh,” he said. “You mean LaGuardia?” He was correct, of course.
It takes me just as long to get to LaGuardia from a hotel in midtown Manhattan as it does for me to fly from Cincinnati to New York. And once you are at the airport, it’s a hot mess. I hear that the terminal update at LaGuardia will be finished in 4 years. This is going to cost $8 billion, plus another $2 billion for an elevated train that connects to the railroad and subway.
Cincinnati built itself a streetcar to nowhere after the city council made a field trip to Portlandia. It was fueled by $45 million in federal “stimulus” grants, disrupted downtown for 9 years instead of 3, and cost $145 million instead of $110.
No one rides the streetcar. It is regularly delayed by people parking on the tracks, and collisions with cars happen regularly. In fact, checking to see if anyone buys a ticket was determined to not be cost effective. The city government cannot close the streetcar for 20 years because the city would otherwise have to give back the $45 million grant used to build it.
How do such boondoggles happen? It was all explained in a book given to me by a new friend in New York. “The Death of Common Sense,” by Philip K. Howard, spells it out.
If you want to fix a problem in any city you must run a gauntlet of meetings and meet regulations, many of which have nothing to do with engineering, quality, or safety. Expect action or approval to take years.
The “you can’t be too careful” movement has assumed a life of its own.
Of course, the same process is true in medicine, only more so! Human lives are at stake, so absolutely no chances can be taken. Medicine is not engineering. And the science of medicine is often so inexact that no one knows when they are taking a chance, or what is the right or wrong thing to do. The paperwork and rules become enormous. The regulations proliferate.
The resulting health care administration costs account for about 25% of health care dollars.
In one recent “you can’t be too careful” moment, I had a Joint Commission inspector tell me he was concerned about patients falling off our power tables when we perform procedures under local anesthesia. Now this has never happened in the last 30 years, but you can’t be too careful! I jokingly suggested we consider giant Velcro straps for the tables, and added that they would be particularly useful for the front office staff chairs. The inspector got excited. He thought giant Velcro straps were a great idea. I am now searching online for giant Velcro straps.
Several years ago, I had a clinical lab improvement inspection and everything was perfect. The inspectors could not find anything wrong, but they had allocated a half day for the inspection. They cast about, and finally insisted I buy a red stamper to indicate on the Mohs maps that the case was clear. I pointed out that a straight line though the map indicated the same thing, and even showed them the colored key codes on the back. No, we must have a red stamp! Now we stamp all the maps, sometimes several times! You can’t be too careful! To head off our next “what can we find” moment, we make sure we leave an expired bottle of stain or tissue dye in the back of the cabinet for the inspectors to find.
Pathologists are expected to report melanomas to the state, but we found out that they were behind in their reporting. So we thought we might help them out with the reporting. What were we thinking!? Upon investigation we obtained an online form that is almost incomprehensible and takes at least an hour to fill out. The form must be submitted online and completed in its entirety. There is a 4-hour webinar to help teach you how to fill it out. I called the state health department to ask for help, I was directed to the webinar, and was told in no uncertain terms that it is serious crime not to report melanoma. Thanks! I will be sure to tell the pathologist.
So avoid LaGuardia Airport for at least 4 more years, come ride the Cincinnati streetcar where you really don’t need a ticket, always leave something small for the inspector to find (mum’s the word), and let me know if you find any giant Velcro straps for sale online!
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].
I jumped in the cab and told the driver to take me straight to hell. “Oh,” he said. “You mean LaGuardia?” He was correct, of course.
It takes me just as long to get to LaGuardia from a hotel in midtown Manhattan as it does for me to fly from Cincinnati to New York. And once you are at the airport, it’s a hot mess. I hear that the terminal update at LaGuardia will be finished in 4 years. This is going to cost $8 billion, plus another $2 billion for an elevated train that connects to the railroad and subway.
Cincinnati built itself a streetcar to nowhere after the city council made a field trip to Portlandia. It was fueled by $45 million in federal “stimulus” grants, disrupted downtown for 9 years instead of 3, and cost $145 million instead of $110.
No one rides the streetcar. It is regularly delayed by people parking on the tracks, and collisions with cars happen regularly. In fact, checking to see if anyone buys a ticket was determined to not be cost effective. The city government cannot close the streetcar for 20 years because the city would otherwise have to give back the $45 million grant used to build it.
How do such boondoggles happen? It was all explained in a book given to me by a new friend in New York. “The Death of Common Sense,” by Philip K. Howard, spells it out.
If you want to fix a problem in any city you must run a gauntlet of meetings and meet regulations, many of which have nothing to do with engineering, quality, or safety. Expect action or approval to take years.
The “you can’t be too careful” movement has assumed a life of its own.
Of course, the same process is true in medicine, only more so! Human lives are at stake, so absolutely no chances can be taken. Medicine is not engineering. And the science of medicine is often so inexact that no one knows when they are taking a chance, or what is the right or wrong thing to do. The paperwork and rules become enormous. The regulations proliferate.
The resulting health care administration costs account for about 25% of health care dollars.
In one recent “you can’t be too careful” moment, I had a Joint Commission inspector tell me he was concerned about patients falling off our power tables when we perform procedures under local anesthesia. Now this has never happened in the last 30 years, but you can’t be too careful! I jokingly suggested we consider giant Velcro straps for the tables, and added that they would be particularly useful for the front office staff chairs. The inspector got excited. He thought giant Velcro straps were a great idea. I am now searching online for giant Velcro straps.
Several years ago, I had a clinical lab improvement inspection and everything was perfect. The inspectors could not find anything wrong, but they had allocated a half day for the inspection. They cast about, and finally insisted I buy a red stamper to indicate on the Mohs maps that the case was clear. I pointed out that a straight line though the map indicated the same thing, and even showed them the colored key codes on the back. No, we must have a red stamp! Now we stamp all the maps, sometimes several times! You can’t be too careful! To head off our next “what can we find” moment, we make sure we leave an expired bottle of stain or tissue dye in the back of the cabinet for the inspectors to find.
Pathologists are expected to report melanomas to the state, but we found out that they were behind in their reporting. So we thought we might help them out with the reporting. What were we thinking!? Upon investigation we obtained an online form that is almost incomprehensible and takes at least an hour to fill out. The form must be submitted online and completed in its entirety. There is a 4-hour webinar to help teach you how to fill it out. I called the state health department to ask for help, I was directed to the webinar, and was told in no uncertain terms that it is serious crime not to report melanoma. Thanks! I will be sure to tell the pathologist.
So avoid LaGuardia Airport for at least 4 more years, come ride the Cincinnati streetcar where you really don’t need a ticket, always leave something small for the inspector to find (mum’s the word), and let me know if you find any giant Velcro straps for sale online!
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].
Diabetic neuropathy: Often silent, often dangerous
SAN DIEGO – Neuropathy can blur the seriousness of injuries, especially in patients with diabetes, and that can lead to severe consequences such as falls, foot ulcers, gangrene, and amputations, said Lucia M. Novak, MSN, ANP-BC, BC-ADM, CDTC, in a presentation on assessing and treating neuropathies at the Metabolic & Endocrine Disease Summit, sponsored by Global Academy for Medical Education.
As many as half of the cases of diabetic neuropathy may have no symptoms, and more than two-thirds of cases of diabetic neuropathy, even some with obvious symptoms, are ignored or missed by clinicians, said Ms. Novak, director of the Riverside Diabetes Center and adjunct assistant professor at the Uniformed Services University of the Health Sciences, both in Bethesda, Md.
At the same time, she said, diabetic neuropathy is very common. It affects an estimated 10%-15% of newly diagnosed patients with type 2 diabetes, 50% of patients with type 2 disease after 10 years, and as many as 30% of patients with prediabetes.
The condition is less common in type 1 diabetes, affecting an estimated 20% of patients after 20 years, she said.
“All we can do in our patients with type 2 diabetes and diabetic neuropathy, is to slow down the progression, although improving glycemic control can prevent it in type 1,” she said, citing findings suggesting that
A 2012 report analyzed research into the effect of glycemic control on neuropathy in diabetes and found a pair of studies that reported a 60%-70% reduction of risk in patients with type 1 diabetes who received regular insulin dosing. However, the evidence for type 2 diabetes was not as definitive, and analysis of findings from eight randomized, controlled trials in patients with type 2 diabetes supported a relatively small reduction in the development of neuropathy in patients with type 2 diabetes who were receiving enhanced glycemic control (Lancet Neurol. 2012;11[6]:521-34).
Ms. Novak focused mainly on peripheral neuropathy, which is believed to account for 50%-75% of all neuropathy in patients with diabetes. She emphasized the importance of screening because it is crucial for preventing foot ulcers, which affect more than a third of patients with diabetes over their lifetimes.
She recommended following the American Diabetes Association’s 2017 position statement on diabetic neuropathy (Diabetes Care. 2017;40[1]:136-54), beginning with performing a visual examination of the feet at every visit.
Comprehensive screening
In patients with type 1 diabetes, there should be an annual comprehensive screening beginning within 5 years of diagnosis. Patients with type 2 disease should be screened at diagnosis and then annually, as outlined in the ADA statement.
The comprehensive exam involves using tools, such as tuning forks and monofilaments, to test sensation. Different tools are required to test both small and large fibers in the foot, Ms. Novak said, and doing both kinds of testing greatly increases the likelihood of detecting neuropathy.
Check for pulse, bone deformities, dry skin
In addition, “you’ll be feeling for their pulses, looking for bony deformities, and looking at anything is going on between the toes [to make sure] the skin is intact,” she said.
Patients with diabetic neuropathy often have dry skin, she said, so make sure they’re moisturizing. “Look at the condition of their shoes,” she added, “which will tell you how they walk.”
Ill-fitting shoes are a common cause of foot ulcers, said Ms. Novak, who noted that some patients refuse to wear unattractive diabetic shoes and prefer to wear more fashionable – and dangerous – tight-fitting shoes.
Treatment options
Glycemic control makes a difference, especially for patients with type 1, as does control of risk factors, such as obesity. But diabetic neuropathy cannot be reversed.
Pain can be managed with a range of medications. “We can’t cure the neuropathy, we can at least help patients with the symptoms so that they can have a good night’s sleep,” she said.
Ms. Novak also suggested passing on the following snippets of advice to patients:
- Do not walk barefoot.
- Check your feet every day.
- Moisturize your skin, and always dry thoroughly between your toes.
- Seek medical attention if your nails cut into your skin or you develop a callus or areas of redness/warmth.
Global Academy and this news organization are owned by the same parent company. Ms. Novak reported relationships with Nova Nordisk, Sanofi, Janssen, and AstraZeneca.
SAN DIEGO – Neuropathy can blur the seriousness of injuries, especially in patients with diabetes, and that can lead to severe consequences such as falls, foot ulcers, gangrene, and amputations, said Lucia M. Novak, MSN, ANP-BC, BC-ADM, CDTC, in a presentation on assessing and treating neuropathies at the Metabolic & Endocrine Disease Summit, sponsored by Global Academy for Medical Education.
As many as half of the cases of diabetic neuropathy may have no symptoms, and more than two-thirds of cases of diabetic neuropathy, even some with obvious symptoms, are ignored or missed by clinicians, said Ms. Novak, director of the Riverside Diabetes Center and adjunct assistant professor at the Uniformed Services University of the Health Sciences, both in Bethesda, Md.
At the same time, she said, diabetic neuropathy is very common. It affects an estimated 10%-15% of newly diagnosed patients with type 2 diabetes, 50% of patients with type 2 disease after 10 years, and as many as 30% of patients with prediabetes.
The condition is less common in type 1 diabetes, affecting an estimated 20% of patients after 20 years, she said.
“All we can do in our patients with type 2 diabetes and diabetic neuropathy, is to slow down the progression, although improving glycemic control can prevent it in type 1,” she said, citing findings suggesting that
A 2012 report analyzed research into the effect of glycemic control on neuropathy in diabetes and found a pair of studies that reported a 60%-70% reduction of risk in patients with type 1 diabetes who received regular insulin dosing. However, the evidence for type 2 diabetes was not as definitive, and analysis of findings from eight randomized, controlled trials in patients with type 2 diabetes supported a relatively small reduction in the development of neuropathy in patients with type 2 diabetes who were receiving enhanced glycemic control (Lancet Neurol. 2012;11[6]:521-34).
Ms. Novak focused mainly on peripheral neuropathy, which is believed to account for 50%-75% of all neuropathy in patients with diabetes. She emphasized the importance of screening because it is crucial for preventing foot ulcers, which affect more than a third of patients with diabetes over their lifetimes.
She recommended following the American Diabetes Association’s 2017 position statement on diabetic neuropathy (Diabetes Care. 2017;40[1]:136-54), beginning with performing a visual examination of the feet at every visit.
Comprehensive screening
In patients with type 1 diabetes, there should be an annual comprehensive screening beginning within 5 years of diagnosis. Patients with type 2 disease should be screened at diagnosis and then annually, as outlined in the ADA statement.
The comprehensive exam involves using tools, such as tuning forks and monofilaments, to test sensation. Different tools are required to test both small and large fibers in the foot, Ms. Novak said, and doing both kinds of testing greatly increases the likelihood of detecting neuropathy.
Check for pulse, bone deformities, dry skin
In addition, “you’ll be feeling for their pulses, looking for bony deformities, and looking at anything is going on between the toes [to make sure] the skin is intact,” she said.
Patients with diabetic neuropathy often have dry skin, she said, so make sure they’re moisturizing. “Look at the condition of their shoes,” she added, “which will tell you how they walk.”
Ill-fitting shoes are a common cause of foot ulcers, said Ms. Novak, who noted that some patients refuse to wear unattractive diabetic shoes and prefer to wear more fashionable – and dangerous – tight-fitting shoes.
Treatment options
Glycemic control makes a difference, especially for patients with type 1, as does control of risk factors, such as obesity. But diabetic neuropathy cannot be reversed.
Pain can be managed with a range of medications. “We can’t cure the neuropathy, we can at least help patients with the symptoms so that they can have a good night’s sleep,” she said.
Ms. Novak also suggested passing on the following snippets of advice to patients:
- Do not walk barefoot.
- Check your feet every day.
- Moisturize your skin, and always dry thoroughly between your toes.
- Seek medical attention if your nails cut into your skin or you develop a callus or areas of redness/warmth.
Global Academy and this news organization are owned by the same parent company. Ms. Novak reported relationships with Nova Nordisk, Sanofi, Janssen, and AstraZeneca.
SAN DIEGO – Neuropathy can blur the seriousness of injuries, especially in patients with diabetes, and that can lead to severe consequences such as falls, foot ulcers, gangrene, and amputations, said Lucia M. Novak, MSN, ANP-BC, BC-ADM, CDTC, in a presentation on assessing and treating neuropathies at the Metabolic & Endocrine Disease Summit, sponsored by Global Academy for Medical Education.
As many as half of the cases of diabetic neuropathy may have no symptoms, and more than two-thirds of cases of diabetic neuropathy, even some with obvious symptoms, are ignored or missed by clinicians, said Ms. Novak, director of the Riverside Diabetes Center and adjunct assistant professor at the Uniformed Services University of the Health Sciences, both in Bethesda, Md.
At the same time, she said, diabetic neuropathy is very common. It affects an estimated 10%-15% of newly diagnosed patients with type 2 diabetes, 50% of patients with type 2 disease after 10 years, and as many as 30% of patients with prediabetes.
The condition is less common in type 1 diabetes, affecting an estimated 20% of patients after 20 years, she said.
“All we can do in our patients with type 2 diabetes and diabetic neuropathy, is to slow down the progression, although improving glycemic control can prevent it in type 1,” she said, citing findings suggesting that
A 2012 report analyzed research into the effect of glycemic control on neuropathy in diabetes and found a pair of studies that reported a 60%-70% reduction of risk in patients with type 1 diabetes who received regular insulin dosing. However, the evidence for type 2 diabetes was not as definitive, and analysis of findings from eight randomized, controlled trials in patients with type 2 diabetes supported a relatively small reduction in the development of neuropathy in patients with type 2 diabetes who were receiving enhanced glycemic control (Lancet Neurol. 2012;11[6]:521-34).
Ms. Novak focused mainly on peripheral neuropathy, which is believed to account for 50%-75% of all neuropathy in patients with diabetes. She emphasized the importance of screening because it is crucial for preventing foot ulcers, which affect more than a third of patients with diabetes over their lifetimes.
She recommended following the American Diabetes Association’s 2017 position statement on diabetic neuropathy (Diabetes Care. 2017;40[1]:136-54), beginning with performing a visual examination of the feet at every visit.
Comprehensive screening
In patients with type 1 diabetes, there should be an annual comprehensive screening beginning within 5 years of diagnosis. Patients with type 2 disease should be screened at diagnosis and then annually, as outlined in the ADA statement.
The comprehensive exam involves using tools, such as tuning forks and monofilaments, to test sensation. Different tools are required to test both small and large fibers in the foot, Ms. Novak said, and doing both kinds of testing greatly increases the likelihood of detecting neuropathy.
Check for pulse, bone deformities, dry skin
In addition, “you’ll be feeling for their pulses, looking for bony deformities, and looking at anything is going on between the toes [to make sure] the skin is intact,” she said.
Patients with diabetic neuropathy often have dry skin, she said, so make sure they’re moisturizing. “Look at the condition of their shoes,” she added, “which will tell you how they walk.”
Ill-fitting shoes are a common cause of foot ulcers, said Ms. Novak, who noted that some patients refuse to wear unattractive diabetic shoes and prefer to wear more fashionable – and dangerous – tight-fitting shoes.
Treatment options
Glycemic control makes a difference, especially for patients with type 1, as does control of risk factors, such as obesity. But diabetic neuropathy cannot be reversed.
Pain can be managed with a range of medications. “We can’t cure the neuropathy, we can at least help patients with the symptoms so that they can have a good night’s sleep,” she said.
Ms. Novak also suggested passing on the following snippets of advice to patients:
- Do not walk barefoot.
- Check your feet every day.
- Moisturize your skin, and always dry thoroughly between your toes.
- Seek medical attention if your nails cut into your skin or you develop a callus or areas of redness/warmth.
Global Academy and this news organization are owned by the same parent company. Ms. Novak reported relationships with Nova Nordisk, Sanofi, Janssen, and AstraZeneca.
EXPERT ANALYSIS FROM MEDS 2019