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Clinical Trials Should Be Standard of Care
MINNEAPOLIS -- Clinical trials should be considered standard of care in oncology, the president of the Association of VA Hematology/Oncology (AVAHO) declared, and he urged colleagues to bypass obstacles and embrace them in patient care.
Clinical trials help many people, not just those in the studies, as they are indicators of robust oncology programs. “There’s a significant correlation between clinical trial activity [at sites] and improvement in survival in cancer,” said oncologist Mark Klein, MD, of the Minneapolis VA Health Care System and University of Minnesota, in a presentation at the 2019 annual meeting of AVAHO.
But the numbers suggest that the VA has lagged behind on the clinical trial front, Dr. Klein said. He pointed to internal statistics from 2001 to 2003, reported in 2010, which found clinical trial participation rates among men in the VA were lower (0.37%) than those of the national rates (0.74%).
Specifically, the VA and national participation rates were 1.16% and 0.30%, respectively, for colorectal cancer, 0.67% and 0.30% for lung cancer, 0.70% and 0.47% for prostate cancer, 0.52% and 0.74% for myeloma. According to Dr. Klein, lung and prostate cancer account for about half of all cancer diagnoses in the VA.
But the participation rates were much higher among the VA hospitals that took part in clinical trials, he said, at 2% for colorectal cancer, 1.4% for lung cancer, 2.5% for prostate cancer, 18.2% for myeloma and 2.07% overall. These numbers make it clear, he said, that it’s possible to improve: “We can do better.”
Dr. Klein pointed to other numbers that suggest the VA facilities that do participate in clinical trials typically do not take part in more than 1 or 2. In 2016, he said, an analysis found that open interventional trials were in progress at 82 VA facilities. About 35 facilities had little activity with only 1 trial in progress. “It has changed since then, but not dramatically.”
Meanwhile, he said, 2016 numbers also showed that about two-thirds of open interventional trials in the VA only included a single VA site. “We weren’t playing together, having consortia and working as a team.”
There are obstacles to improvement, he said, and fixes will take time. “It probably takes 5, 10-plus years,” he said.
These barriers include:
- Lack of adequate trial offering. Changing regulations is key here;
- Strict eligibility criteria. Easing the criteria and more effective screening are helpful;
- Long distances to travel to cancer clinics. Telemedicine could make a difference on this front;
- Patient concerns about being a “guinea pig.” Patient education can help;
- Provider concerns such as worry about extra work. The VA can work to ease burdens and provide incentives for trial enrollment; and
- High costs. Study sponsors may pay for trial drugs, helping facilities to lower expenses or even reach cost neutrality.
There are more solutions to boost participation, Dr. Klein said, including education, engagement and partnerships.
On the partnership front, he highlighted NAVIGATE, an interagency consortium of the VA and the National Cancer Institute. This collaboration aims to boost enrollment of VA patients in clinical trials, he said, and there are designated NAVIGATE sites across the country from coast to coast.
A partnership between AVAHO and the National Association of Veterans’ Research and Education Foundations is also boosting clinical trials in VA oncology. Thanks to this partnership, 1 trial has completed accrual, 6 multisite trials are active, and 5 are starting up, according to Dr. Klein.
In the big picture, Dr. Klein said, it’s clear that “we’ve got a lot of barriers in the VA. Anybody who works in the VA knows that. But I’ve seen this meeting grow and grow, and I’ve seen teamwork and partnerships form.”
MINNEAPOLIS -- Clinical trials should be considered standard of care in oncology, the president of the Association of VA Hematology/Oncology (AVAHO) declared, and he urged colleagues to bypass obstacles and embrace them in patient care.
Clinical trials help many people, not just those in the studies, as they are indicators of robust oncology programs. “There’s a significant correlation between clinical trial activity [at sites] and improvement in survival in cancer,” said oncologist Mark Klein, MD, of the Minneapolis VA Health Care System and University of Minnesota, in a presentation at the 2019 annual meeting of AVAHO.
But the numbers suggest that the VA has lagged behind on the clinical trial front, Dr. Klein said. He pointed to internal statistics from 2001 to 2003, reported in 2010, which found clinical trial participation rates among men in the VA were lower (0.37%) than those of the national rates (0.74%).
Specifically, the VA and national participation rates were 1.16% and 0.30%, respectively, for colorectal cancer, 0.67% and 0.30% for lung cancer, 0.70% and 0.47% for prostate cancer, 0.52% and 0.74% for myeloma. According to Dr. Klein, lung and prostate cancer account for about half of all cancer diagnoses in the VA.
But the participation rates were much higher among the VA hospitals that took part in clinical trials, he said, at 2% for colorectal cancer, 1.4% for lung cancer, 2.5% for prostate cancer, 18.2% for myeloma and 2.07% overall. These numbers make it clear, he said, that it’s possible to improve: “We can do better.”
Dr. Klein pointed to other numbers that suggest the VA facilities that do participate in clinical trials typically do not take part in more than 1 or 2. In 2016, he said, an analysis found that open interventional trials were in progress at 82 VA facilities. About 35 facilities had little activity with only 1 trial in progress. “It has changed since then, but not dramatically.”
Meanwhile, he said, 2016 numbers also showed that about two-thirds of open interventional trials in the VA only included a single VA site. “We weren’t playing together, having consortia and working as a team.”
There are obstacles to improvement, he said, and fixes will take time. “It probably takes 5, 10-plus years,” he said.
These barriers include:
- Lack of adequate trial offering. Changing regulations is key here;
- Strict eligibility criteria. Easing the criteria and more effective screening are helpful;
- Long distances to travel to cancer clinics. Telemedicine could make a difference on this front;
- Patient concerns about being a “guinea pig.” Patient education can help;
- Provider concerns such as worry about extra work. The VA can work to ease burdens and provide incentives for trial enrollment; and
- High costs. Study sponsors may pay for trial drugs, helping facilities to lower expenses or even reach cost neutrality.
There are more solutions to boost participation, Dr. Klein said, including education, engagement and partnerships.
On the partnership front, he highlighted NAVIGATE, an interagency consortium of the VA and the National Cancer Institute. This collaboration aims to boost enrollment of VA patients in clinical trials, he said, and there are designated NAVIGATE sites across the country from coast to coast.
A partnership between AVAHO and the National Association of Veterans’ Research and Education Foundations is also boosting clinical trials in VA oncology. Thanks to this partnership, 1 trial has completed accrual, 6 multisite trials are active, and 5 are starting up, according to Dr. Klein.
In the big picture, Dr. Klein said, it’s clear that “we’ve got a lot of barriers in the VA. Anybody who works in the VA knows that. But I’ve seen this meeting grow and grow, and I’ve seen teamwork and partnerships form.”
MINNEAPOLIS -- Clinical trials should be considered standard of care in oncology, the president of the Association of VA Hematology/Oncology (AVAHO) declared, and he urged colleagues to bypass obstacles and embrace them in patient care.
Clinical trials help many people, not just those in the studies, as they are indicators of robust oncology programs. “There’s a significant correlation between clinical trial activity [at sites] and improvement in survival in cancer,” said oncologist Mark Klein, MD, of the Minneapolis VA Health Care System and University of Minnesota, in a presentation at the 2019 annual meeting of AVAHO.
But the numbers suggest that the VA has lagged behind on the clinical trial front, Dr. Klein said. He pointed to internal statistics from 2001 to 2003, reported in 2010, which found clinical trial participation rates among men in the VA were lower (0.37%) than those of the national rates (0.74%).
Specifically, the VA and national participation rates were 1.16% and 0.30%, respectively, for colorectal cancer, 0.67% and 0.30% for lung cancer, 0.70% and 0.47% for prostate cancer, 0.52% and 0.74% for myeloma. According to Dr. Klein, lung and prostate cancer account for about half of all cancer diagnoses in the VA.
But the participation rates were much higher among the VA hospitals that took part in clinical trials, he said, at 2% for colorectal cancer, 1.4% for lung cancer, 2.5% for prostate cancer, 18.2% for myeloma and 2.07% overall. These numbers make it clear, he said, that it’s possible to improve: “We can do better.”
Dr. Klein pointed to other numbers that suggest the VA facilities that do participate in clinical trials typically do not take part in more than 1 or 2. In 2016, he said, an analysis found that open interventional trials were in progress at 82 VA facilities. About 35 facilities had little activity with only 1 trial in progress. “It has changed since then, but not dramatically.”
Meanwhile, he said, 2016 numbers also showed that about two-thirds of open interventional trials in the VA only included a single VA site. “We weren’t playing together, having consortia and working as a team.”
There are obstacles to improvement, he said, and fixes will take time. “It probably takes 5, 10-plus years,” he said.
These barriers include:
- Lack of adequate trial offering. Changing regulations is key here;
- Strict eligibility criteria. Easing the criteria and more effective screening are helpful;
- Long distances to travel to cancer clinics. Telemedicine could make a difference on this front;
- Patient concerns about being a “guinea pig.” Patient education can help;
- Provider concerns such as worry about extra work. The VA can work to ease burdens and provide incentives for trial enrollment; and
- High costs. Study sponsors may pay for trial drugs, helping facilities to lower expenses or even reach cost neutrality.
There are more solutions to boost participation, Dr. Klein said, including education, engagement and partnerships.
On the partnership front, he highlighted NAVIGATE, an interagency consortium of the VA and the National Cancer Institute. This collaboration aims to boost enrollment of VA patients in clinical trials, he said, and there are designated NAVIGATE sites across the country from coast to coast.
A partnership between AVAHO and the National Association of Veterans’ Research and Education Foundations is also boosting clinical trials in VA oncology. Thanks to this partnership, 1 trial has completed accrual, 6 multisite trials are active, and 5 are starting up, according to Dr. Klein.
In the big picture, Dr. Klein said, it’s clear that “we’ve got a lot of barriers in the VA. Anybody who works in the VA knows that. But I’ve seen this meeting grow and grow, and I’ve seen teamwork and partnerships form.”
Financial Education for Health Care Providers
Health care provider (HCP) well-being has become a central topic as health care agencies increasingly recognize that stress leads to turnover and reduced efficacy.1 Financial health of HCPs is one aspect of overall well-being that has received little attention. We all work at the US Department of Veterans Affairs (VA) as psychologists and believe that there is a need to attend to financial literacy within the health care professions, a call that also has been made by physicians.2 For instance, a frequently mentioned aspect of financial literacy involves learning to effectively manage student loan debt. Another less often discussed facet is the need to save money for retirement early in one’s career to reap the benefits of compound interest: This is a particular concern for HCPs who were in graduate/medical school when they would have optimally started saving for retirement. Delaying retirement savings can have significant financial consequences, which can have a negative effect on well-being.
A few years ago, we started teaching advanced psychology trainees about financial well-being and were startled at the students’ lack of knowledge. For example, many students did not understand basic financial concepts, including the difference between a pension and a 401k/403b system of retirement savings—a knowledge gap that the authors speculate persists throughout some professionals’ careers. Research suggests that lack of knowledge in an area feels aversive and may result in procrastination or an inability to move toward a goal.3,4 Yet, postponing saving is problematic as it attenuates the effect of compound interest, thus making it difficult to accrue wealth.5 To address the lack of financial training among psychologists, the authors designed a seminar to provide retirement/financial-planning information to early career psychologists. This information fits the concept of “just in time” education: Disseminating knowledge when it is most likely to be useful, put into practice, and thus retained.6
Methods
In consultation with human resources officials at the VA, a 90-minute seminar was created to educate psychologists about saving for retirement. The seminar was recorded so that psychologists who were not able to attend in-person could view it at a later date. The seminar mainly covered systems of retirement (especially the VAspecific Thrift Savings Plan [TSP]), basic concepts of investing, ways of determining how much to save for retirement, and tax advantages of increased saving. It also provided simple retirement planning rules of thumb, as such heuristics have been shown to lead to greater behavior change than more unsystematic approaches.7 Key points included:
- Psychologists should try to approximately replace their current salary during retirement;
- There is no option to borrow money for retirement; the only sources of income for the retiree are social security, a possible pension, and any money saved;
- Psychologists and many other HCPs were in school during their prime saving years and tend to have lower salaries than that of other professional groups with similar amounts of education, so they should save aggressively earlier in their career;
- Early career psychologists should ensure that money saved for retirement is invested in relatively “aggressive” options, such as stock index funds (vs bond funds); and
- The tax benefits of allocating more income toward retirement savings in a tax-deferred savings plan such as the TSP can make it seem cheaper to invest, which can make it more attractive to immediately increase one’s savings.
As with any other savings plan, there are no guarantees or one-size-fits-all solutions, and finance professionals typically advise diversifying retirement savings (eg, stocks, bonds, real estate), to include both TSP and non-TSP plans in the case of VA employees.
To assess the usefulness of this seminar, the authors conducted a process improvement case study. The institutional review board of the Milwaukee VA Medical Center (VAMC) determined the study to be exempt as it was considered process improvement rather than research. Two assessment measures were created: a 5-item, anonymous measure of attendee satisfaction was administered immediately following the seminar, which assessed the extent to which presenters were engaging, material was presented clearly, presenters effectively used examples and illustrations, presenters effectively used slides/visual aids, and objectives were met (5-point Likert scale from “Needs major improvement” to “Excellent”).
Second, an internally developed anonymous pre- and postseminar survey was administered to assess changes in retirement- related knowledge, attitudes, and behaviors (3 months before the seminar [8 questions] and 2 months after [9 questions]). The survey assessed knowledge of retirement benefits (eg, difference between Roth and traditional retirement savings plans), general investment actions (eg, investing in TSP, investing in the TSP G fund, and investing sufficiently to earn the full employer match), and postseminar actions taken (eg, logging on to tsp.gov, increasing TSP contribution). Participants’ responses were anonymous, so the authors compared average behavior before and after the seminar rather than comparing individuals’ pre- and postseminar comments.
Results
About one-third (n = 28) of the Milwaukee VAMC psychologists attended, viewed, or presented/designed the seminar. Of the 12 participants who attended the seminar in person, all rated the presentation as excellent in each domain, with the exception of 1 participant (good). Anecdotally, participants approached presenters immediately after the presentation and up to 2 years later to indicate that the presentation was a useful retirement planning resource. A total of 27 psychologists completed the preseminar survey. Sixteen psychologists completed the postseminar survey and indicated that they attended/viewed the retirement seminar. Participants’ perceived knowledge of retirement benefits was assessed with response options, including nonexistent, vague, good, and sophisticated.
There was a significant change from preto postseminar, such that psychologists at postseminar felt that they had a better understanding of their retirement benefit options (Mann-Whitney U = 65.5, n1 = 27, n2 = 16, P < .01). The modal response preseminar was “vague” (67%) and postseminar was “good” (88%). There also were changes that were meaningful though not statistically significant: The percentage who had moved their money from the default, low-yield fund increased from 70% at preseminar to 88% at postseminar (Fisher exact test, 1-sided, P = .31). Also, fewer people reported on the postseminar survey that they were not sure whether they were invested in a Roth individual retirement account (IRA) or traditional TSP, indicating a trend toward significantly increased knowledge of their investments (Fisher exact test, 1-sided, P = .076).
Most important at follow-up, several behavior changes were reported. Most people (56%) had logged on to the TSP website to check on their account. A substantial number (26%) increased their contribution amount, and 6% moved money from the default fund. Overall, every respondent at follow-up confirmed having taken at least 1 of the actions assessed by the survey.
Conclusion
Based on the authors’ experience and research into financial education among HCPs, it is recommended that psychologists and other disciplines offer opportunities for retirement education at all levels of training. Financial education is likely to be most helpful if it is tailored toward a specific discipline, workplace, and time frame (eg, early career physicians may need more information about loan repayment and may need to invest in more aggressive retirement funds).8 Although many employers provide access to general financial education from outside companies, information provided by informed members of one’s field may be particularly helpful (eg, our seminar was curated for a psychology audience).
We found that the process of creating such a seminar was not burdensome and was educational for presenters as well as attendees. Further, it need not be intimidating to accumulate information to share; especially for those health care providers who have not made financial well-being a priority, learning and deploying a few targeted strategies can lead to increased peace of mind about retirement savings. Overall, we encourage a focus on financial literacy for all health care professions, including physicians who often may graduate with greater debts. Emphasizing early and aggressive financial literacy as an important aspect of provider well-being may help to produce healthier, wealthier, and overall better health care providers.2
Acknowledgments
This manuscript is partially the result of work supported with resources and the use of facilities at the Clement J. Zablocki VAMC, Milwaukee, Wisconsin. We thank Milwaukee VA retirement specialist, Vicki Heckman, for her invaluable advice in the preparation of these materials and the Psychology Advancement Workgroup at the Milwaukee VAMC for providing the impetus and support for this project.
1. Zhang Y, Feng X. The relationship between job satisfaction, burnout, and turnover intention among physicians from urban state-owned medical institutions in Hubei, China: a cross-sectional study. BMC Health Serv Res. 2011;11(1):235.
2. Chandrakantan A. Why is there no financial literacy 101 for doctors? https://opmed.doximity.com/an-open -call-to-residency-training-programs-and-trainees-to -facilitate-financial-literacy-bb762e585ed8. Published August 21, 2017. Accessed August 22, 2019.
3. Iyengar SS, Huberman G, Jiang W. How much choice is too much: determinants of individual contributions in 401K retirement plans. In: Mitchell OS, Utkus S, eds. Pension Design and Structure: New Lessons From Behavioral Finance. Oxford: Oxford University Press; 2004:83-95.
4. Parker AM, de Bruin WB, Yoong J, Willis R. Inappropriate confidence and retirement planning: four studies with a national sample. J Behav Decis Mak. 2012;25(4):382-389.
5. Lusardi A, Mitchell OS. Baby boomer retirement security: the roles of planning, financial literacy, and housing wealth. J Monet Econ. 2007;54(1):205-224.
6. Chub C. It’s time to teach financial literacy to young doctors. https://www.cnbc.com/2016/12/08/teaching -financial-literacy-to-young-doctors.html. Published December 8, 2016. Accessed August 22, 2019.
7. Binswanger J, Carman KG. How real people make longterm decisions: the case of retirement preparation. J Econ Behav Org. 2012;81(1):39-60.
8. Knoll MA. The role of behavioral economics and behavioral decision making in Americans’ retirement savings decisions. Soc Secur Bull. 2010;70(4):1-23.
Health care provider (HCP) well-being has become a central topic as health care agencies increasingly recognize that stress leads to turnover and reduced efficacy.1 Financial health of HCPs is one aspect of overall well-being that has received little attention. We all work at the US Department of Veterans Affairs (VA) as psychologists and believe that there is a need to attend to financial literacy within the health care professions, a call that also has been made by physicians.2 For instance, a frequently mentioned aspect of financial literacy involves learning to effectively manage student loan debt. Another less often discussed facet is the need to save money for retirement early in one’s career to reap the benefits of compound interest: This is a particular concern for HCPs who were in graduate/medical school when they would have optimally started saving for retirement. Delaying retirement savings can have significant financial consequences, which can have a negative effect on well-being.
A few years ago, we started teaching advanced psychology trainees about financial well-being and were startled at the students’ lack of knowledge. For example, many students did not understand basic financial concepts, including the difference between a pension and a 401k/403b system of retirement savings—a knowledge gap that the authors speculate persists throughout some professionals’ careers. Research suggests that lack of knowledge in an area feels aversive and may result in procrastination or an inability to move toward a goal.3,4 Yet, postponing saving is problematic as it attenuates the effect of compound interest, thus making it difficult to accrue wealth.5 To address the lack of financial training among psychologists, the authors designed a seminar to provide retirement/financial-planning information to early career psychologists. This information fits the concept of “just in time” education: Disseminating knowledge when it is most likely to be useful, put into practice, and thus retained.6
Methods
In consultation with human resources officials at the VA, a 90-minute seminar was created to educate psychologists about saving for retirement. The seminar was recorded so that psychologists who were not able to attend in-person could view it at a later date. The seminar mainly covered systems of retirement (especially the VAspecific Thrift Savings Plan [TSP]), basic concepts of investing, ways of determining how much to save for retirement, and tax advantages of increased saving. It also provided simple retirement planning rules of thumb, as such heuristics have been shown to lead to greater behavior change than more unsystematic approaches.7 Key points included:
- Psychologists should try to approximately replace their current salary during retirement;
- There is no option to borrow money for retirement; the only sources of income for the retiree are social security, a possible pension, and any money saved;
- Psychologists and many other HCPs were in school during their prime saving years and tend to have lower salaries than that of other professional groups with similar amounts of education, so they should save aggressively earlier in their career;
- Early career psychologists should ensure that money saved for retirement is invested in relatively “aggressive” options, such as stock index funds (vs bond funds); and
- The tax benefits of allocating more income toward retirement savings in a tax-deferred savings plan such as the TSP can make it seem cheaper to invest, which can make it more attractive to immediately increase one’s savings.
As with any other savings plan, there are no guarantees or one-size-fits-all solutions, and finance professionals typically advise diversifying retirement savings (eg, stocks, bonds, real estate), to include both TSP and non-TSP plans in the case of VA employees.
To assess the usefulness of this seminar, the authors conducted a process improvement case study. The institutional review board of the Milwaukee VA Medical Center (VAMC) determined the study to be exempt as it was considered process improvement rather than research. Two assessment measures were created: a 5-item, anonymous measure of attendee satisfaction was administered immediately following the seminar, which assessed the extent to which presenters were engaging, material was presented clearly, presenters effectively used examples and illustrations, presenters effectively used slides/visual aids, and objectives were met (5-point Likert scale from “Needs major improvement” to “Excellent”).
Second, an internally developed anonymous pre- and postseminar survey was administered to assess changes in retirement- related knowledge, attitudes, and behaviors (3 months before the seminar [8 questions] and 2 months after [9 questions]). The survey assessed knowledge of retirement benefits (eg, difference between Roth and traditional retirement savings plans), general investment actions (eg, investing in TSP, investing in the TSP G fund, and investing sufficiently to earn the full employer match), and postseminar actions taken (eg, logging on to tsp.gov, increasing TSP contribution). Participants’ responses were anonymous, so the authors compared average behavior before and after the seminar rather than comparing individuals’ pre- and postseminar comments.
Results
About one-third (n = 28) of the Milwaukee VAMC psychologists attended, viewed, or presented/designed the seminar. Of the 12 participants who attended the seminar in person, all rated the presentation as excellent in each domain, with the exception of 1 participant (good). Anecdotally, participants approached presenters immediately after the presentation and up to 2 years later to indicate that the presentation was a useful retirement planning resource. A total of 27 psychologists completed the preseminar survey. Sixteen psychologists completed the postseminar survey and indicated that they attended/viewed the retirement seminar. Participants’ perceived knowledge of retirement benefits was assessed with response options, including nonexistent, vague, good, and sophisticated.
There was a significant change from preto postseminar, such that psychologists at postseminar felt that they had a better understanding of their retirement benefit options (Mann-Whitney U = 65.5, n1 = 27, n2 = 16, P < .01). The modal response preseminar was “vague” (67%) and postseminar was “good” (88%). There also were changes that were meaningful though not statistically significant: The percentage who had moved their money from the default, low-yield fund increased from 70% at preseminar to 88% at postseminar (Fisher exact test, 1-sided, P = .31). Also, fewer people reported on the postseminar survey that they were not sure whether they were invested in a Roth individual retirement account (IRA) or traditional TSP, indicating a trend toward significantly increased knowledge of their investments (Fisher exact test, 1-sided, P = .076).
Most important at follow-up, several behavior changes were reported. Most people (56%) had logged on to the TSP website to check on their account. A substantial number (26%) increased their contribution amount, and 6% moved money from the default fund. Overall, every respondent at follow-up confirmed having taken at least 1 of the actions assessed by the survey.
Conclusion
Based on the authors’ experience and research into financial education among HCPs, it is recommended that psychologists and other disciplines offer opportunities for retirement education at all levels of training. Financial education is likely to be most helpful if it is tailored toward a specific discipline, workplace, and time frame (eg, early career physicians may need more information about loan repayment and may need to invest in more aggressive retirement funds).8 Although many employers provide access to general financial education from outside companies, information provided by informed members of one’s field may be particularly helpful (eg, our seminar was curated for a psychology audience).
We found that the process of creating such a seminar was not burdensome and was educational for presenters as well as attendees. Further, it need not be intimidating to accumulate information to share; especially for those health care providers who have not made financial well-being a priority, learning and deploying a few targeted strategies can lead to increased peace of mind about retirement savings. Overall, we encourage a focus on financial literacy for all health care professions, including physicians who often may graduate with greater debts. Emphasizing early and aggressive financial literacy as an important aspect of provider well-being may help to produce healthier, wealthier, and overall better health care providers.2
Acknowledgments
This manuscript is partially the result of work supported with resources and the use of facilities at the Clement J. Zablocki VAMC, Milwaukee, Wisconsin. We thank Milwaukee VA retirement specialist, Vicki Heckman, for her invaluable advice in the preparation of these materials and the Psychology Advancement Workgroup at the Milwaukee VAMC for providing the impetus and support for this project.
Health care provider (HCP) well-being has become a central topic as health care agencies increasingly recognize that stress leads to turnover and reduced efficacy.1 Financial health of HCPs is one aspect of overall well-being that has received little attention. We all work at the US Department of Veterans Affairs (VA) as psychologists and believe that there is a need to attend to financial literacy within the health care professions, a call that also has been made by physicians.2 For instance, a frequently mentioned aspect of financial literacy involves learning to effectively manage student loan debt. Another less often discussed facet is the need to save money for retirement early in one’s career to reap the benefits of compound interest: This is a particular concern for HCPs who were in graduate/medical school when they would have optimally started saving for retirement. Delaying retirement savings can have significant financial consequences, which can have a negative effect on well-being.
A few years ago, we started teaching advanced psychology trainees about financial well-being and were startled at the students’ lack of knowledge. For example, many students did not understand basic financial concepts, including the difference between a pension and a 401k/403b system of retirement savings—a knowledge gap that the authors speculate persists throughout some professionals’ careers. Research suggests that lack of knowledge in an area feels aversive and may result in procrastination or an inability to move toward a goal.3,4 Yet, postponing saving is problematic as it attenuates the effect of compound interest, thus making it difficult to accrue wealth.5 To address the lack of financial training among psychologists, the authors designed a seminar to provide retirement/financial-planning information to early career psychologists. This information fits the concept of “just in time” education: Disseminating knowledge when it is most likely to be useful, put into practice, and thus retained.6
Methods
In consultation with human resources officials at the VA, a 90-minute seminar was created to educate psychologists about saving for retirement. The seminar was recorded so that psychologists who were not able to attend in-person could view it at a later date. The seminar mainly covered systems of retirement (especially the VAspecific Thrift Savings Plan [TSP]), basic concepts of investing, ways of determining how much to save for retirement, and tax advantages of increased saving. It also provided simple retirement planning rules of thumb, as such heuristics have been shown to lead to greater behavior change than more unsystematic approaches.7 Key points included:
- Psychologists should try to approximately replace their current salary during retirement;
- There is no option to borrow money for retirement; the only sources of income for the retiree are social security, a possible pension, and any money saved;
- Psychologists and many other HCPs were in school during their prime saving years and tend to have lower salaries than that of other professional groups with similar amounts of education, so they should save aggressively earlier in their career;
- Early career psychologists should ensure that money saved for retirement is invested in relatively “aggressive” options, such as stock index funds (vs bond funds); and
- The tax benefits of allocating more income toward retirement savings in a tax-deferred savings plan such as the TSP can make it seem cheaper to invest, which can make it more attractive to immediately increase one’s savings.
As with any other savings plan, there are no guarantees or one-size-fits-all solutions, and finance professionals typically advise diversifying retirement savings (eg, stocks, bonds, real estate), to include both TSP and non-TSP plans in the case of VA employees.
To assess the usefulness of this seminar, the authors conducted a process improvement case study. The institutional review board of the Milwaukee VA Medical Center (VAMC) determined the study to be exempt as it was considered process improvement rather than research. Two assessment measures were created: a 5-item, anonymous measure of attendee satisfaction was administered immediately following the seminar, which assessed the extent to which presenters were engaging, material was presented clearly, presenters effectively used examples and illustrations, presenters effectively used slides/visual aids, and objectives were met (5-point Likert scale from “Needs major improvement” to “Excellent”).
Second, an internally developed anonymous pre- and postseminar survey was administered to assess changes in retirement- related knowledge, attitudes, and behaviors (3 months before the seminar [8 questions] and 2 months after [9 questions]). The survey assessed knowledge of retirement benefits (eg, difference between Roth and traditional retirement savings plans), general investment actions (eg, investing in TSP, investing in the TSP G fund, and investing sufficiently to earn the full employer match), and postseminar actions taken (eg, logging on to tsp.gov, increasing TSP contribution). Participants’ responses were anonymous, so the authors compared average behavior before and after the seminar rather than comparing individuals’ pre- and postseminar comments.
Results
About one-third (n = 28) of the Milwaukee VAMC psychologists attended, viewed, or presented/designed the seminar. Of the 12 participants who attended the seminar in person, all rated the presentation as excellent in each domain, with the exception of 1 participant (good). Anecdotally, participants approached presenters immediately after the presentation and up to 2 years later to indicate that the presentation was a useful retirement planning resource. A total of 27 psychologists completed the preseminar survey. Sixteen psychologists completed the postseminar survey and indicated that they attended/viewed the retirement seminar. Participants’ perceived knowledge of retirement benefits was assessed with response options, including nonexistent, vague, good, and sophisticated.
There was a significant change from preto postseminar, such that psychologists at postseminar felt that they had a better understanding of their retirement benefit options (Mann-Whitney U = 65.5, n1 = 27, n2 = 16, P < .01). The modal response preseminar was “vague” (67%) and postseminar was “good” (88%). There also were changes that were meaningful though not statistically significant: The percentage who had moved their money from the default, low-yield fund increased from 70% at preseminar to 88% at postseminar (Fisher exact test, 1-sided, P = .31). Also, fewer people reported on the postseminar survey that they were not sure whether they were invested in a Roth individual retirement account (IRA) or traditional TSP, indicating a trend toward significantly increased knowledge of their investments (Fisher exact test, 1-sided, P = .076).
Most important at follow-up, several behavior changes were reported. Most people (56%) had logged on to the TSP website to check on their account. A substantial number (26%) increased their contribution amount, and 6% moved money from the default fund. Overall, every respondent at follow-up confirmed having taken at least 1 of the actions assessed by the survey.
Conclusion
Based on the authors’ experience and research into financial education among HCPs, it is recommended that psychologists and other disciplines offer opportunities for retirement education at all levels of training. Financial education is likely to be most helpful if it is tailored toward a specific discipline, workplace, and time frame (eg, early career physicians may need more information about loan repayment and may need to invest in more aggressive retirement funds).8 Although many employers provide access to general financial education from outside companies, information provided by informed members of one’s field may be particularly helpful (eg, our seminar was curated for a psychology audience).
We found that the process of creating such a seminar was not burdensome and was educational for presenters as well as attendees. Further, it need not be intimidating to accumulate information to share; especially for those health care providers who have not made financial well-being a priority, learning and deploying a few targeted strategies can lead to increased peace of mind about retirement savings. Overall, we encourage a focus on financial literacy for all health care professions, including physicians who often may graduate with greater debts. Emphasizing early and aggressive financial literacy as an important aspect of provider well-being may help to produce healthier, wealthier, and overall better health care providers.2
Acknowledgments
This manuscript is partially the result of work supported with resources and the use of facilities at the Clement J. Zablocki VAMC, Milwaukee, Wisconsin. We thank Milwaukee VA retirement specialist, Vicki Heckman, for her invaluable advice in the preparation of these materials and the Psychology Advancement Workgroup at the Milwaukee VAMC for providing the impetus and support for this project.
1. Zhang Y, Feng X. The relationship between job satisfaction, burnout, and turnover intention among physicians from urban state-owned medical institutions in Hubei, China: a cross-sectional study. BMC Health Serv Res. 2011;11(1):235.
2. Chandrakantan A. Why is there no financial literacy 101 for doctors? https://opmed.doximity.com/an-open -call-to-residency-training-programs-and-trainees-to -facilitate-financial-literacy-bb762e585ed8. Published August 21, 2017. Accessed August 22, 2019.
3. Iyengar SS, Huberman G, Jiang W. How much choice is too much: determinants of individual contributions in 401K retirement plans. In: Mitchell OS, Utkus S, eds. Pension Design and Structure: New Lessons From Behavioral Finance. Oxford: Oxford University Press; 2004:83-95.
4. Parker AM, de Bruin WB, Yoong J, Willis R. Inappropriate confidence and retirement planning: four studies with a national sample. J Behav Decis Mak. 2012;25(4):382-389.
5. Lusardi A, Mitchell OS. Baby boomer retirement security: the roles of planning, financial literacy, and housing wealth. J Monet Econ. 2007;54(1):205-224.
6. Chub C. It’s time to teach financial literacy to young doctors. https://www.cnbc.com/2016/12/08/teaching -financial-literacy-to-young-doctors.html. Published December 8, 2016. Accessed August 22, 2019.
7. Binswanger J, Carman KG. How real people make longterm decisions: the case of retirement preparation. J Econ Behav Org. 2012;81(1):39-60.
8. Knoll MA. The role of behavioral economics and behavioral decision making in Americans’ retirement savings decisions. Soc Secur Bull. 2010;70(4):1-23.
1. Zhang Y, Feng X. The relationship between job satisfaction, burnout, and turnover intention among physicians from urban state-owned medical institutions in Hubei, China: a cross-sectional study. BMC Health Serv Res. 2011;11(1):235.
2. Chandrakantan A. Why is there no financial literacy 101 for doctors? https://opmed.doximity.com/an-open -call-to-residency-training-programs-and-trainees-to -facilitate-financial-literacy-bb762e585ed8. Published August 21, 2017. Accessed August 22, 2019.
3. Iyengar SS, Huberman G, Jiang W. How much choice is too much: determinants of individual contributions in 401K retirement plans. In: Mitchell OS, Utkus S, eds. Pension Design and Structure: New Lessons From Behavioral Finance. Oxford: Oxford University Press; 2004:83-95.
4. Parker AM, de Bruin WB, Yoong J, Willis R. Inappropriate confidence and retirement planning: four studies with a national sample. J Behav Decis Mak. 2012;25(4):382-389.
5. Lusardi A, Mitchell OS. Baby boomer retirement security: the roles of planning, financial literacy, and housing wealth. J Monet Econ. 2007;54(1):205-224.
6. Chub C. It’s time to teach financial literacy to young doctors. https://www.cnbc.com/2016/12/08/teaching -financial-literacy-to-young-doctors.html. Published December 8, 2016. Accessed August 22, 2019.
7. Binswanger J, Carman KG. How real people make longterm decisions: the case of retirement preparation. J Econ Behav Org. 2012;81(1):39-60.
8. Knoll MA. The role of behavioral economics and behavioral decision making in Americans’ retirement savings decisions. Soc Secur Bull. 2010;70(4):1-23.
Observation versus inpatient status
A dilemma for hospitalists and patients
A federal effort to reduce health care expenditures has left many older Medicare recipients experiencing the sticker shock of “observation status.” Patients who are not sick enough to meet inpatient admission criteria, however, still require hospitalization, and may be placed under Medicare observation care.
Seniors can get frustrated, confused, and anxious as their status can be changed while they are in the hospital, and they may receive large medical bills after they are discharged. The Centers for Medicare & Medicaid Services’ “3-day rule” mandates that Medicare will not pay for skilled nursing facility care unless the patient is admitted as an “inpatient” for at least 3 days. Observation days do not count towards this 3-day hospital stay.
There has been an increase in outpatient services over the years since 2006. The 2018 State of Hospital Medicine Report (SoHM) highlights the percentage of discharges based on hospitalists’ billed Current Procedural Terminology codes. Codes 99217 (observation discharge) and 99238-99239 (inpatient discharge) were used to calculate the percentages. 80.7% of adult medicine hospitalist discharges were coded using inpatient discharge codes, while 19.3% of patients were discharged with observation discharge codes.
In the 2016 SoHM report, the ratio was 76.0% inpatient and 21.1% observation codes and in the 2014 report we saw 80.3% inpatient and 16.1% observation discharges (see table 1). But in both of those surveys, same-day admission/discharge codes were also separately reported, which did not occur in 2018. That makes year-over-year comparison of the data challenging.
Interestingly, the 2017 CMS data on Evaluation and Management Codes by Specialty for the first time included separate data for hospitalists, based on hospitalists who credentialed with Medicare using the new C6 specialty code. Based on that data, when looking only at inpatient (99238-99239) and observation (99217) codes, 83% of the discharges were inpatient and 17% were observation.
Physicians feel the pressure of strained patient-physician relationships as a consequence of patients feeling the brunt of the financing gap related to observation status. Patients often feel they were not warned adequately about the financial ramifications of observation status. Even if Medicare beneficiaries have received the Medicare Outpatient Observation Notice, outlined by the Notice of Observation Treatment and Implication for Care Eligibility Act, they have no rights to appeal.
Currently Medicare beneficiaries admitted as inpatients only incur a Part A deductible; they are not liable for tests, procedures, and nursing care. On the other hand, in observation status all services are billed separately. For Medicare Part B services (which covers observation care) patients must pay 20% of services after the Part B deductible, which could result in a huge financial burden. Costs for skilled nursing facilities, when they are not covered by Medicare Part A, because of the 3-day rule, can easily go up to $20,000 or more. Medicare beneficiaries have no cap on costs for an observation stay. In some cases, hospitals have to apply a condition code 44 and retroactively change the stay to observation status.
I attended the 2019 Society of Hospital Medicine Annual Conference in Washington. Hospitalists from all parts of the country advocated on Capitol Hill against the “observation bill,” and “meet and greets” with congressional representatives increased their opposition to the bill. These efforts may work in favor of protecting patients from surprise medical bills. Hospital medicine physicians are on the front lines for providing health care in the hospital setting; they have demanded a fix to this legislative loophole which brings high out of pocket costs to our nation’s most vulnerable seniors. The observation status “2-midnight rule” utilized by CMS has increased financial barriers and decreased access to postacute care, affecting the provision of high-quality care for patients.
My hospital has a utilization review committee which reviews all cases to determine the appropriateness of an inpatient versus an observation designation. (An interesting question is whether the financial resources used to support this additional staff could be better assigned to provide high-quality care.) Distribution of these patients is determined on very specific criteria as outlined by Medicare. Observation is basically considered a billing method implemented by payers to decrease dollars paid to acute care hospitals for inpatient care. It pertains to admission status, not to the level of care provided in the hospital. Unfortunately, it is felt that no two payers define observation the same way. A few examples of common observation diagnoses are chest pain, abdominal pain, syncope, and migraine headache; in other words, patients with diagnoses where it is suspected that a less than 24-hour stay in the hospital could be sufficient.
Observation care is increasing and can sometimes contribute to work flow impediments and frustrations in hospitalists; thus, hospitalists are demanding reform. It has been proposed that observation could be eliminated altogether by creating a payment blend of inpatient/outpatient rates. Another option could be to assign lower Diagnosis Related Group coding to lower acuity disease processes, instead of separate observation reimbursement.
Patients and doctors lament that “Once you are in the hospital, you are admitted!” I don’t know the right answer that would solve the observation versus inpatient dilemma, but it is intriguing to consider changes in policy that might focus on the complete elimination of observation status.
Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.
A dilemma for hospitalists and patients
A dilemma for hospitalists and patients
A federal effort to reduce health care expenditures has left many older Medicare recipients experiencing the sticker shock of “observation status.” Patients who are not sick enough to meet inpatient admission criteria, however, still require hospitalization, and may be placed under Medicare observation care.
Seniors can get frustrated, confused, and anxious as their status can be changed while they are in the hospital, and they may receive large medical bills after they are discharged. The Centers for Medicare & Medicaid Services’ “3-day rule” mandates that Medicare will not pay for skilled nursing facility care unless the patient is admitted as an “inpatient” for at least 3 days. Observation days do not count towards this 3-day hospital stay.
There has been an increase in outpatient services over the years since 2006. The 2018 State of Hospital Medicine Report (SoHM) highlights the percentage of discharges based on hospitalists’ billed Current Procedural Terminology codes. Codes 99217 (observation discharge) and 99238-99239 (inpatient discharge) were used to calculate the percentages. 80.7% of adult medicine hospitalist discharges were coded using inpatient discharge codes, while 19.3% of patients were discharged with observation discharge codes.
In the 2016 SoHM report, the ratio was 76.0% inpatient and 21.1% observation codes and in the 2014 report we saw 80.3% inpatient and 16.1% observation discharges (see table 1). But in both of those surveys, same-day admission/discharge codes were also separately reported, which did not occur in 2018. That makes year-over-year comparison of the data challenging.
Interestingly, the 2017 CMS data on Evaluation and Management Codes by Specialty for the first time included separate data for hospitalists, based on hospitalists who credentialed with Medicare using the new C6 specialty code. Based on that data, when looking only at inpatient (99238-99239) and observation (99217) codes, 83% of the discharges were inpatient and 17% were observation.
Physicians feel the pressure of strained patient-physician relationships as a consequence of patients feeling the brunt of the financing gap related to observation status. Patients often feel they were not warned adequately about the financial ramifications of observation status. Even if Medicare beneficiaries have received the Medicare Outpatient Observation Notice, outlined by the Notice of Observation Treatment and Implication for Care Eligibility Act, they have no rights to appeal.
Currently Medicare beneficiaries admitted as inpatients only incur a Part A deductible; they are not liable for tests, procedures, and nursing care. On the other hand, in observation status all services are billed separately. For Medicare Part B services (which covers observation care) patients must pay 20% of services after the Part B deductible, which could result in a huge financial burden. Costs for skilled nursing facilities, when they are not covered by Medicare Part A, because of the 3-day rule, can easily go up to $20,000 or more. Medicare beneficiaries have no cap on costs for an observation stay. In some cases, hospitals have to apply a condition code 44 and retroactively change the stay to observation status.
I attended the 2019 Society of Hospital Medicine Annual Conference in Washington. Hospitalists from all parts of the country advocated on Capitol Hill against the “observation bill,” and “meet and greets” with congressional representatives increased their opposition to the bill. These efforts may work in favor of protecting patients from surprise medical bills. Hospital medicine physicians are on the front lines for providing health care in the hospital setting; they have demanded a fix to this legislative loophole which brings high out of pocket costs to our nation’s most vulnerable seniors. The observation status “2-midnight rule” utilized by CMS has increased financial barriers and decreased access to postacute care, affecting the provision of high-quality care for patients.
My hospital has a utilization review committee which reviews all cases to determine the appropriateness of an inpatient versus an observation designation. (An interesting question is whether the financial resources used to support this additional staff could be better assigned to provide high-quality care.) Distribution of these patients is determined on very specific criteria as outlined by Medicare. Observation is basically considered a billing method implemented by payers to decrease dollars paid to acute care hospitals for inpatient care. It pertains to admission status, not to the level of care provided in the hospital. Unfortunately, it is felt that no two payers define observation the same way. A few examples of common observation diagnoses are chest pain, abdominal pain, syncope, and migraine headache; in other words, patients with diagnoses where it is suspected that a less than 24-hour stay in the hospital could be sufficient.
Observation care is increasing and can sometimes contribute to work flow impediments and frustrations in hospitalists; thus, hospitalists are demanding reform. It has been proposed that observation could be eliminated altogether by creating a payment blend of inpatient/outpatient rates. Another option could be to assign lower Diagnosis Related Group coding to lower acuity disease processes, instead of separate observation reimbursement.
Patients and doctors lament that “Once you are in the hospital, you are admitted!” I don’t know the right answer that would solve the observation versus inpatient dilemma, but it is intriguing to consider changes in policy that might focus on the complete elimination of observation status.
Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.
A federal effort to reduce health care expenditures has left many older Medicare recipients experiencing the sticker shock of “observation status.” Patients who are not sick enough to meet inpatient admission criteria, however, still require hospitalization, and may be placed under Medicare observation care.
Seniors can get frustrated, confused, and anxious as their status can be changed while they are in the hospital, and they may receive large medical bills after they are discharged. The Centers for Medicare & Medicaid Services’ “3-day rule” mandates that Medicare will not pay for skilled nursing facility care unless the patient is admitted as an “inpatient” for at least 3 days. Observation days do not count towards this 3-day hospital stay.
There has been an increase in outpatient services over the years since 2006. The 2018 State of Hospital Medicine Report (SoHM) highlights the percentage of discharges based on hospitalists’ billed Current Procedural Terminology codes. Codes 99217 (observation discharge) and 99238-99239 (inpatient discharge) were used to calculate the percentages. 80.7% of adult medicine hospitalist discharges were coded using inpatient discharge codes, while 19.3% of patients were discharged with observation discharge codes.
In the 2016 SoHM report, the ratio was 76.0% inpatient and 21.1% observation codes and in the 2014 report we saw 80.3% inpatient and 16.1% observation discharges (see table 1). But in both of those surveys, same-day admission/discharge codes were also separately reported, which did not occur in 2018. That makes year-over-year comparison of the data challenging.
Interestingly, the 2017 CMS data on Evaluation and Management Codes by Specialty for the first time included separate data for hospitalists, based on hospitalists who credentialed with Medicare using the new C6 specialty code. Based on that data, when looking only at inpatient (99238-99239) and observation (99217) codes, 83% of the discharges were inpatient and 17% were observation.
Physicians feel the pressure of strained patient-physician relationships as a consequence of patients feeling the brunt of the financing gap related to observation status. Patients often feel they were not warned adequately about the financial ramifications of observation status. Even if Medicare beneficiaries have received the Medicare Outpatient Observation Notice, outlined by the Notice of Observation Treatment and Implication for Care Eligibility Act, they have no rights to appeal.
Currently Medicare beneficiaries admitted as inpatients only incur a Part A deductible; they are not liable for tests, procedures, and nursing care. On the other hand, in observation status all services are billed separately. For Medicare Part B services (which covers observation care) patients must pay 20% of services after the Part B deductible, which could result in a huge financial burden. Costs for skilled nursing facilities, when they are not covered by Medicare Part A, because of the 3-day rule, can easily go up to $20,000 or more. Medicare beneficiaries have no cap on costs for an observation stay. In some cases, hospitals have to apply a condition code 44 and retroactively change the stay to observation status.
I attended the 2019 Society of Hospital Medicine Annual Conference in Washington. Hospitalists from all parts of the country advocated on Capitol Hill against the “observation bill,” and “meet and greets” with congressional representatives increased their opposition to the bill. These efforts may work in favor of protecting patients from surprise medical bills. Hospital medicine physicians are on the front lines for providing health care in the hospital setting; they have demanded a fix to this legislative loophole which brings high out of pocket costs to our nation’s most vulnerable seniors. The observation status “2-midnight rule” utilized by CMS has increased financial barriers and decreased access to postacute care, affecting the provision of high-quality care for patients.
My hospital has a utilization review committee which reviews all cases to determine the appropriateness of an inpatient versus an observation designation. (An interesting question is whether the financial resources used to support this additional staff could be better assigned to provide high-quality care.) Distribution of these patients is determined on very specific criteria as outlined by Medicare. Observation is basically considered a billing method implemented by payers to decrease dollars paid to acute care hospitals for inpatient care. It pertains to admission status, not to the level of care provided in the hospital. Unfortunately, it is felt that no two payers define observation the same way. A few examples of common observation diagnoses are chest pain, abdominal pain, syncope, and migraine headache; in other words, patients with diagnoses where it is suspected that a less than 24-hour stay in the hospital could be sufficient.
Observation care is increasing and can sometimes contribute to work flow impediments and frustrations in hospitalists; thus, hospitalists are demanding reform. It has been proposed that observation could be eliminated altogether by creating a payment blend of inpatient/outpatient rates. Another option could be to assign lower Diagnosis Related Group coding to lower acuity disease processes, instead of separate observation reimbursement.
Patients and doctors lament that “Once you are in the hospital, you are admitted!” I don’t know the right answer that would solve the observation versus inpatient dilemma, but it is intriguing to consider changes in policy that might focus on the complete elimination of observation status.
Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.
Prolonged Antibiotic Treatment in Newborns May Promote Multidrug Resistance
Antibiotics given to preterm infants can set them up for health problems later in life; research has shown, including allergies, psoriasis, diabetes, and inflammatory bowel disease. Researchers who conducted a National Institutes of Health (NIH)-funded study have added to that body of knowledge with their finding that treating preterm infants with long-term antibiotics could have lasting effects by promoting multidrug-resistant gut bacteria.
They used high-speed DNA sequencing and advanced computational analysis to study stool samples from 32 infants born very preterm who received antibiotic treatment for 21 months in the hospital and after discharge, then compared those with results from 9 very preterm infants treated with antibiotics for > 1 week and 17 healthy term and late-term infants who had not received antibiotics.
The infants on long-term antibiotics had less diverse bacterial populations in their gut, and those bacteria contained more antibiotic-resistant genes.
Strikingly, the genomes of the high-antibiotic-use samples contained genes for resistance to antibiotics typically not given to newborns, such as ciprofloxacin and chloramphenicol. The researchers say this may mean that the genes originate in multidrug-resistant bacteria. Using a particular antibiotic may trigger resistance to other antibiotics even if they were not used.
“The collateral damage of early-life antibiotic treatment and hospitalization in preterm infants is long lasting,” the researchers say. They urge development of strategies to protect these highly vulnerable patients.
Antibiotics given to preterm infants can set them up for health problems later in life; research has shown, including allergies, psoriasis, diabetes, and inflammatory bowel disease. Researchers who conducted a National Institutes of Health (NIH)-funded study have added to that body of knowledge with their finding that treating preterm infants with long-term antibiotics could have lasting effects by promoting multidrug-resistant gut bacteria.
They used high-speed DNA sequencing and advanced computational analysis to study stool samples from 32 infants born very preterm who received antibiotic treatment for 21 months in the hospital and after discharge, then compared those with results from 9 very preterm infants treated with antibiotics for > 1 week and 17 healthy term and late-term infants who had not received antibiotics.
The infants on long-term antibiotics had less diverse bacterial populations in their gut, and those bacteria contained more antibiotic-resistant genes.
Strikingly, the genomes of the high-antibiotic-use samples contained genes for resistance to antibiotics typically not given to newborns, such as ciprofloxacin and chloramphenicol. The researchers say this may mean that the genes originate in multidrug-resistant bacteria. Using a particular antibiotic may trigger resistance to other antibiotics even if they were not used.
“The collateral damage of early-life antibiotic treatment and hospitalization in preterm infants is long lasting,” the researchers say. They urge development of strategies to protect these highly vulnerable patients.
Antibiotics given to preterm infants can set them up for health problems later in life; research has shown, including allergies, psoriasis, diabetes, and inflammatory bowel disease. Researchers who conducted a National Institutes of Health (NIH)-funded study have added to that body of knowledge with their finding that treating preterm infants with long-term antibiotics could have lasting effects by promoting multidrug-resistant gut bacteria.
They used high-speed DNA sequencing and advanced computational analysis to study stool samples from 32 infants born very preterm who received antibiotic treatment for 21 months in the hospital and after discharge, then compared those with results from 9 very preterm infants treated with antibiotics for > 1 week and 17 healthy term and late-term infants who had not received antibiotics.
The infants on long-term antibiotics had less diverse bacterial populations in their gut, and those bacteria contained more antibiotic-resistant genes.
Strikingly, the genomes of the high-antibiotic-use samples contained genes for resistance to antibiotics typically not given to newborns, such as ciprofloxacin and chloramphenicol. The researchers say this may mean that the genes originate in multidrug-resistant bacteria. Using a particular antibiotic may trigger resistance to other antibiotics even if they were not used.
“The collateral damage of early-life antibiotic treatment and hospitalization in preterm infants is long lasting,” the researchers say. They urge development of strategies to protect these highly vulnerable patients.
Milrinone beats dobutamine in extending survival in HF
PHILADELPHIA – Milrinone was associated with a 50% reduction in mortality, compared with dobutamine, in patients with heart failure who were receiving home inotropes as a bridge to advanced therapies, according to results of a large U.S. registry study.
The survival profile for milrinone was more favorable than that for dobutamine across various indications for use, including bridge to transplant, bridge to mechanical support, and palliation.
The findings illustrate an “urgent need” for randomized trials that compare inotropic therapy strategies in patients with end-stage heart failure, said investigator Behram P. Mody, MD, of the division of cardiology at the University of California, San Diego, La Jolla.
“Although [there is] the possibility of selection bias and there are confounding variables, this consistent finding may reflect a true benefit of milrinone,” Dr. Mody said in a presentation at the annual scientific meeting of the Heart Failure Society of America
The evidence to support use of continuous outpatient intravenous inotropic therapy in stage D heart failure is limited and comes mainly from case series, and small, randomized trials demonstrating poor outcomes, Dr. Mody explained.
“Long-term survival associated with home inotropes in the modern era of guideline-directed medical and device therapy is poorly defined,” he said.
The retrospective study Dr. Mody presented at the meeting included 1,149 patients (mean age, 60 years; 29.9% women) who received continuous intravenous outpatient inotropic therapy (milrinone or dobutamine) from 2015 to 2017. This is possibly the largest body of data reported to date of patients receiving home inotropes, he said.
For the overall population, the estimated 1-year survival rate was 71% with milrinone, compared with 46% for dobutamine (P less than .0001), Dr. Mody reported. After adjusting for age, gender, weight, and indication, milrinone use was still significantly associated with lower mortality, compared with dobutamine (hazard ratio, 0.50; 95% confidence interval, 0.39-0.64; P less than .0001).
The survival benefit of milrinone over dobutamine was also significant in subsets of patients receiving home inotropes as bridge to transplant, bridge to mechanical support, or palliation. A similar trend, though not statistically significant, was seen for inotropes used as a bridge to decision, he added.
Mortality was generally higher in patients receiving inotropes as palliation, as opposed to bridge therapy, with 1-year survival of 55.0% and 65.6%, respectively, and median survival of 461 days and 584 days.
These findings suggest home inotropes can be “beneficial” in patients with end-stage heart failure in an era of guideline-directed medical therapy and greater defibrillator use, Dr. Mody said.
“I’m not saying that it should replace left ventricular assist devices as the bridge to transplant,” he added, “but it could be an alternative strategy for our patients.”
No funding source was given. Dr. Mody had no disclosures related to the study.
SOURCE: Mody BP et al. J Card Fail. 2019 Sep 14. doi: 10.1016/j.cardfail.2019.07.021.
PHILADELPHIA – Milrinone was associated with a 50% reduction in mortality, compared with dobutamine, in patients with heart failure who were receiving home inotropes as a bridge to advanced therapies, according to results of a large U.S. registry study.
The survival profile for milrinone was more favorable than that for dobutamine across various indications for use, including bridge to transplant, bridge to mechanical support, and palliation.
The findings illustrate an “urgent need” for randomized trials that compare inotropic therapy strategies in patients with end-stage heart failure, said investigator Behram P. Mody, MD, of the division of cardiology at the University of California, San Diego, La Jolla.
“Although [there is] the possibility of selection bias and there are confounding variables, this consistent finding may reflect a true benefit of milrinone,” Dr. Mody said in a presentation at the annual scientific meeting of the Heart Failure Society of America
The evidence to support use of continuous outpatient intravenous inotropic therapy in stage D heart failure is limited and comes mainly from case series, and small, randomized trials demonstrating poor outcomes, Dr. Mody explained.
“Long-term survival associated with home inotropes in the modern era of guideline-directed medical and device therapy is poorly defined,” he said.
The retrospective study Dr. Mody presented at the meeting included 1,149 patients (mean age, 60 years; 29.9% women) who received continuous intravenous outpatient inotropic therapy (milrinone or dobutamine) from 2015 to 2017. This is possibly the largest body of data reported to date of patients receiving home inotropes, he said.
For the overall population, the estimated 1-year survival rate was 71% with milrinone, compared with 46% for dobutamine (P less than .0001), Dr. Mody reported. After adjusting for age, gender, weight, and indication, milrinone use was still significantly associated with lower mortality, compared with dobutamine (hazard ratio, 0.50; 95% confidence interval, 0.39-0.64; P less than .0001).
The survival benefit of milrinone over dobutamine was also significant in subsets of patients receiving home inotropes as bridge to transplant, bridge to mechanical support, or palliation. A similar trend, though not statistically significant, was seen for inotropes used as a bridge to decision, he added.
Mortality was generally higher in patients receiving inotropes as palliation, as opposed to bridge therapy, with 1-year survival of 55.0% and 65.6%, respectively, and median survival of 461 days and 584 days.
These findings suggest home inotropes can be “beneficial” in patients with end-stage heart failure in an era of guideline-directed medical therapy and greater defibrillator use, Dr. Mody said.
“I’m not saying that it should replace left ventricular assist devices as the bridge to transplant,” he added, “but it could be an alternative strategy for our patients.”
No funding source was given. Dr. Mody had no disclosures related to the study.
SOURCE: Mody BP et al. J Card Fail. 2019 Sep 14. doi: 10.1016/j.cardfail.2019.07.021.
PHILADELPHIA – Milrinone was associated with a 50% reduction in mortality, compared with dobutamine, in patients with heart failure who were receiving home inotropes as a bridge to advanced therapies, according to results of a large U.S. registry study.
The survival profile for milrinone was more favorable than that for dobutamine across various indications for use, including bridge to transplant, bridge to mechanical support, and palliation.
The findings illustrate an “urgent need” for randomized trials that compare inotropic therapy strategies in patients with end-stage heart failure, said investigator Behram P. Mody, MD, of the division of cardiology at the University of California, San Diego, La Jolla.
“Although [there is] the possibility of selection bias and there are confounding variables, this consistent finding may reflect a true benefit of milrinone,” Dr. Mody said in a presentation at the annual scientific meeting of the Heart Failure Society of America
The evidence to support use of continuous outpatient intravenous inotropic therapy in stage D heart failure is limited and comes mainly from case series, and small, randomized trials demonstrating poor outcomes, Dr. Mody explained.
“Long-term survival associated with home inotropes in the modern era of guideline-directed medical and device therapy is poorly defined,” he said.
The retrospective study Dr. Mody presented at the meeting included 1,149 patients (mean age, 60 years; 29.9% women) who received continuous intravenous outpatient inotropic therapy (milrinone or dobutamine) from 2015 to 2017. This is possibly the largest body of data reported to date of patients receiving home inotropes, he said.
For the overall population, the estimated 1-year survival rate was 71% with milrinone, compared with 46% for dobutamine (P less than .0001), Dr. Mody reported. After adjusting for age, gender, weight, and indication, milrinone use was still significantly associated with lower mortality, compared with dobutamine (hazard ratio, 0.50; 95% confidence interval, 0.39-0.64; P less than .0001).
The survival benefit of milrinone over dobutamine was also significant in subsets of patients receiving home inotropes as bridge to transplant, bridge to mechanical support, or palliation. A similar trend, though not statistically significant, was seen for inotropes used as a bridge to decision, he added.
Mortality was generally higher in patients receiving inotropes as palliation, as opposed to bridge therapy, with 1-year survival of 55.0% and 65.6%, respectively, and median survival of 461 days and 584 days.
These findings suggest home inotropes can be “beneficial” in patients with end-stage heart failure in an era of guideline-directed medical therapy and greater defibrillator use, Dr. Mody said.
“I’m not saying that it should replace left ventricular assist devices as the bridge to transplant,” he added, “but it could be an alternative strategy for our patients.”
No funding source was given. Dr. Mody had no disclosures related to the study.
SOURCE: Mody BP et al. J Card Fail. 2019 Sep 14. doi: 10.1016/j.cardfail.2019.07.021.
REPORTING FROM HFSA 2019
Rates of off-label prescribing for children continue to increase
Physicians continue to prescribe off-label drugs for children, with rates increasing over a 10-year period from 2006 to 2015, according to findings from a new study.
The increase occurred despite recent legislation aimed at encouraging pediatric clinical trials, with the intention of improving the “quality of evidence and the number of drugs approved for children,” Divya Hoon of Rutgers University in New Brunswick, N.J., and colleagues wrote in Pediatrics.
“[Our] results can help inform ongoing education, research, and policies around efficacious, effective, and safe use of medications in children,” the researchers said.
To determine trends in, and categories of, drugs prescribed off label, the researchers used data from the National Ambulatory Medical Care Surveys for all pediatric visits and subsequent drug orders from 2006 to 2015. They focused on 141 drugs that are predominantly or exclusively used in systemic formulations and that had been ordered at least 30 times.
At least one off-label systemic drug order occurred at 18.5% of the 1.74 billion estimated ambulatory pediatric visits (95% confidence interval, 17.7%-19.3%), totaling 41.2 million off-label orders per year. The primary reason for a drug being considered off label was that it was for an unapproved condition (74.6%), followed by patient age (17.6%) and weight (0.6%). Absolute and relative rates of off-label ordering increased throughout the study, especially in regard to antihistamines and psychotropic drugs, the investigators said.
In an accompanying editorial, Katelyn Yackey, MD, of the University of Kentucky Children’s Hospital, Lexington, and Rachel Stanley, MD, of Nationwide Children’s Hospital, Columbus, Ohio, stated that “off label is not synonymous with off evidence” and emphasized the need for more clinical trials of medications for children (Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1571).
“Although drugs are often used off label, there may be sufficient preliminary research about a medical condition and particular drugs to support their use,” they wrote. While recognizing that evaluating medications in pediatric patients has been challenging, they added that “children continue to receive medications off label and for unapproved conditions,” so studies that evaluate “safety, efficacy, pharmacokinetics, and optimal dosing in pediatric patients” remain a necessity.
Though the research featured a long study period and large study population, the authors recognized its possible limitations, including the exclusion of less commonly ordered drugs, the inability to determine drug formulation or dosage, and the fact that the survey data captured only ordered medicines and not whether they were actually dispensed or consumed.
The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rutgers Robert Wood Johnson Medical School Summer Research Fellowship. The authors reported no conflicts of interest.
SOURCE: Hoon D et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-0896.
Physicians continue to prescribe off-label drugs for children, with rates increasing over a 10-year period from 2006 to 2015, according to findings from a new study.
The increase occurred despite recent legislation aimed at encouraging pediatric clinical trials, with the intention of improving the “quality of evidence and the number of drugs approved for children,” Divya Hoon of Rutgers University in New Brunswick, N.J., and colleagues wrote in Pediatrics.
“[Our] results can help inform ongoing education, research, and policies around efficacious, effective, and safe use of medications in children,” the researchers said.
To determine trends in, and categories of, drugs prescribed off label, the researchers used data from the National Ambulatory Medical Care Surveys for all pediatric visits and subsequent drug orders from 2006 to 2015. They focused on 141 drugs that are predominantly or exclusively used in systemic formulations and that had been ordered at least 30 times.
At least one off-label systemic drug order occurred at 18.5% of the 1.74 billion estimated ambulatory pediatric visits (95% confidence interval, 17.7%-19.3%), totaling 41.2 million off-label orders per year. The primary reason for a drug being considered off label was that it was for an unapproved condition (74.6%), followed by patient age (17.6%) and weight (0.6%). Absolute and relative rates of off-label ordering increased throughout the study, especially in regard to antihistamines and psychotropic drugs, the investigators said.
In an accompanying editorial, Katelyn Yackey, MD, of the University of Kentucky Children’s Hospital, Lexington, and Rachel Stanley, MD, of Nationwide Children’s Hospital, Columbus, Ohio, stated that “off label is not synonymous with off evidence” and emphasized the need for more clinical trials of medications for children (Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1571).
“Although drugs are often used off label, there may be sufficient preliminary research about a medical condition and particular drugs to support their use,” they wrote. While recognizing that evaluating medications in pediatric patients has been challenging, they added that “children continue to receive medications off label and for unapproved conditions,” so studies that evaluate “safety, efficacy, pharmacokinetics, and optimal dosing in pediatric patients” remain a necessity.
Though the research featured a long study period and large study population, the authors recognized its possible limitations, including the exclusion of less commonly ordered drugs, the inability to determine drug formulation or dosage, and the fact that the survey data captured only ordered medicines and not whether they were actually dispensed or consumed.
The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rutgers Robert Wood Johnson Medical School Summer Research Fellowship. The authors reported no conflicts of interest.
SOURCE: Hoon D et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-0896.
Physicians continue to prescribe off-label drugs for children, with rates increasing over a 10-year period from 2006 to 2015, according to findings from a new study.
The increase occurred despite recent legislation aimed at encouraging pediatric clinical trials, with the intention of improving the “quality of evidence and the number of drugs approved for children,” Divya Hoon of Rutgers University in New Brunswick, N.J., and colleagues wrote in Pediatrics.
“[Our] results can help inform ongoing education, research, and policies around efficacious, effective, and safe use of medications in children,” the researchers said.
To determine trends in, and categories of, drugs prescribed off label, the researchers used data from the National Ambulatory Medical Care Surveys for all pediatric visits and subsequent drug orders from 2006 to 2015. They focused on 141 drugs that are predominantly or exclusively used in systemic formulations and that had been ordered at least 30 times.
At least one off-label systemic drug order occurred at 18.5% of the 1.74 billion estimated ambulatory pediatric visits (95% confidence interval, 17.7%-19.3%), totaling 41.2 million off-label orders per year. The primary reason for a drug being considered off label was that it was for an unapproved condition (74.6%), followed by patient age (17.6%) and weight (0.6%). Absolute and relative rates of off-label ordering increased throughout the study, especially in regard to antihistamines and psychotropic drugs, the investigators said.
In an accompanying editorial, Katelyn Yackey, MD, of the University of Kentucky Children’s Hospital, Lexington, and Rachel Stanley, MD, of Nationwide Children’s Hospital, Columbus, Ohio, stated that “off label is not synonymous with off evidence” and emphasized the need for more clinical trials of medications for children (Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1571).
“Although drugs are often used off label, there may be sufficient preliminary research about a medical condition and particular drugs to support their use,” they wrote. While recognizing that evaluating medications in pediatric patients has been challenging, they added that “children continue to receive medications off label and for unapproved conditions,” so studies that evaluate “safety, efficacy, pharmacokinetics, and optimal dosing in pediatric patients” remain a necessity.
Though the research featured a long study period and large study population, the authors recognized its possible limitations, including the exclusion of less commonly ordered drugs, the inability to determine drug formulation or dosage, and the fact that the survey data captured only ordered medicines and not whether they were actually dispensed or consumed.
The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rutgers Robert Wood Johnson Medical School Summer Research Fellowship. The authors reported no conflicts of interest.
SOURCE: Hoon D et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-0896.
FROM PEDIATRICS
Key clinical point:
Major finding: At least one off-label systemic drug order occurred at 18.5% of the 1.74 billion estimated ambulatory pediatric visits (95% CI, 17.7%-19.3%).
Study details: A retrospective study of serial, cross-sectional data from the National Ambulatory Medical Care Surveys (2006-2015).
Disclosures: The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rutgers Robert Wood Johnson Medical School Summer Research Fellowship. The authors reported no conflicts of interest.
Source: Hoon D et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-0896.
Severe Pretibial Myxedema Refractory to Systemic Immunosuppressants
To the Editor:
A 55-year-old man with a history of Graves disease treated with radioactive iodine and Graves ophthalmopathy was referred to our dermatology clinic by his endocrinologist with a 2-year history of severe pretibial myxedema (PM) that had failed treatment with systemic immunosuppressants after diagnosis by an outside dermatologist in the United Kingdom approximately 2 years prior. In addition to burning pain and difficulty walking associated with progressive “enlarging” of the lower legs and feet (Figure, A and B), the patient reported that he consistently had to find larger shoes (size 13 at the current presentation). His medications included gabapentin for foot pain and levothyroxine for hypothyroidism.
Physical examination revealed diffuse, waxy, indurated, flesh-colored and erythematous plaques and nodules with a peau d’orange appearance on the dorsal feet, ankles, and lower legs. Laboratory evaluation revealed a thyroid stimulating immunoglobulin level of 617% (reference range, <140%) and mild anemia. His thyroid stimulating hormone and free T4 levels, a comprehensive metabolic panel, and lipid panel were all within reference range.
Treatment with oral, intravenous, and intralesional steroids; cyclosporine; and azathioprine were tried prior to presentation to our clinic with no improvement. The patient was started on pentoxifylline (400 mg 3 times daily), intralesional triamcinolone acetonide (5 mg/mL every 3–4 weeks), clobetasol propionate ointment 0.05% under occlusion twice daily, short-stretch bandages, and compression stockings (20–30 mm Hg). The baseline circumference of the extremities also were measured (right ankle, 12 in; left ankle, 11.5 in; right and left mid-plantar feet, 12 in).
At 3-week follow-up, the lesions had flattened with softening of the skin. The patient reported his legs were smaller and he had bought a new pair of shoes at size 8.5 (Figure, C). He noted less pain and difficulty with walking. The circumference of the extremities was measured again (right ankle, 10.2 in; left ankle, 10 in; right and left mid-plantar feet, 10.5 in). The patient continued treatment and was followed for 3 months. At each visit, clinical improvement was noted as well as report of decreased pain while walking (Figure, D).
Pretibial myxedema is a known manifestation of Graves disease that almost always occurs in the presence of Graves ophthalmopathy. Pretibial myxedema occurs in 0.5% to 4.3% of patients with Graves disease and variably manifests as diffuse nonpitting edema or localized, waxy, indurated plaques or nodules.1,2
The proposed pathogenesis of PM is that autoantibodies directed against the thyroid receptors cross-react with the fibroblasts of the skin,2,3 which stimulates the fibroblasts to produce high amounts of glycosaminoglycans, especially hyaluronic acid, in the dermis and subcutis of the pretibial area. It is not known why there is a predilection for the anterior shins, but mechanical factors and dependent position (ie, leg position is lower than the level of the heart) may be involved.4
The mainstay of treatment for PM is topical and intralesional corticosteroids, which may have a benefit in mild to moderate disease; however, in cases of severe disease that is refractory to intralesional and topical corticosteroids under occlusion, more aggressive treatment is required. Systemic immunosuppressants such as cyclosporine, azathioprine, and corticosteroids have proven useful in some but not all cases.5,6
Our patient did not respond to treatment with systemic and intralesional corticosteroids, cyclosporine, or azathioprine before he presented to our clinic; however, the lesions were dramatically improved after 3 weeks of treatment with pentoxifylline, intralesional and topical corticosteroids under occlusion, short-stretch bandages, and compression stockings.
Pentoxifylline inhibits the proliferation and glycosaminoglycan synthesis of cultured fibroblasts derived from patients with Graves ophthalmology and PM.7 It has been shown to reduce thickness of skin lesions when used in combination with topical or intralesional steroids.3,8 Corticosteroids are thought to block fibroblast-mediated glycosaminoglycan production.3,9 The deposition of mucin, which is comprised of glycosaminoglycans, expands the dermal tissue and causes fluid to accumulate; it also causes compression of dermal lymphatics, worsening the dermal edema. Because fluid accumulates, the use of short-stretch bandages and compression stockings may provide additional benefit, as was seen in our patient, whose shoe size decreased from a 13 to an 8.5 within 3 weeks of treatment.
In conclusion, the combination of pentoxifylline, intralesional and topical corticosteroids under occlusion, short-stretch bandages, and compression garments can cause substantial improvement in severe PM refractory to systemic immunosuppressants.
- Susser WS, Heermans AG, Chapman MS, et al. Elephantiasic pretibial myxedema: a novel treatment for an uncommon disorder. J Am Acad Dermatol. 2002;46:723-726.
- Kriss J. Pathogenesis and treatment of pretibial myxedema. Endocrinol Metab Clin North Am. 1987;16:409-415.
- Pineda AM, Tianco EA, Tan JB, et al. Oral pentoxifylline and topical clobetasol propionate ointment in the treatment of pretibial myxoedema, with concomitant improvement of Graves’ ophthalmopathy. J Eur Acad Dermatol Venereol. 2007; 21:1441-1443.
- Fatourechi V. Pretibial myxedema. Am J Clin Dermatol. 2005;6:295-309.
- Benoit FL, Greenspan FS. Corticoid therapy for pretibial myxedema: observations on the long-acting thyroid stimulator. Ann Intern Med. 1967;66:711-720.
- Hanke CW, Bergfeld WF, Guirguis MN, et al. Pretibial myxedema (elephantiasis form): treatment with cytotoxic therapy. Cleve Clin Q. 1983;50:183-188.
- Chang CC, Chang TC, Kao SC, et al. Pentoxifylline inhibits the proliferation and glycosaminoglycan synthesis of cultured fibroblasts derived from patients with Graves’ ophthalmopathy and pretibial myxoedema. Acta Endocrinol (Copenh). 1993;129:322-327.
- Engin B, Gümüs¸el M, Ozdemir M, et al. Successful combined pentoxifylline and intralesional triamcinolone acetonide treatment of severe pretibial myxedema. Dermatol Online J. 2007;13:16.
- Lang PG, Sisson JC, Lynch PJ. Intralesional triamcinolone therapy for pretibial myxedema. Arch Dermatol. 1975;111:197-202.
To the Editor:
A 55-year-old man with a history of Graves disease treated with radioactive iodine and Graves ophthalmopathy was referred to our dermatology clinic by his endocrinologist with a 2-year history of severe pretibial myxedema (PM) that had failed treatment with systemic immunosuppressants after diagnosis by an outside dermatologist in the United Kingdom approximately 2 years prior. In addition to burning pain and difficulty walking associated with progressive “enlarging” of the lower legs and feet (Figure, A and B), the patient reported that he consistently had to find larger shoes (size 13 at the current presentation). His medications included gabapentin for foot pain and levothyroxine for hypothyroidism.
Physical examination revealed diffuse, waxy, indurated, flesh-colored and erythematous plaques and nodules with a peau d’orange appearance on the dorsal feet, ankles, and lower legs. Laboratory evaluation revealed a thyroid stimulating immunoglobulin level of 617% (reference range, <140%) and mild anemia. His thyroid stimulating hormone and free T4 levels, a comprehensive metabolic panel, and lipid panel were all within reference range.
Treatment with oral, intravenous, and intralesional steroids; cyclosporine; and azathioprine were tried prior to presentation to our clinic with no improvement. The patient was started on pentoxifylline (400 mg 3 times daily), intralesional triamcinolone acetonide (5 mg/mL every 3–4 weeks), clobetasol propionate ointment 0.05% under occlusion twice daily, short-stretch bandages, and compression stockings (20–30 mm Hg). The baseline circumference of the extremities also were measured (right ankle, 12 in; left ankle, 11.5 in; right and left mid-plantar feet, 12 in).
At 3-week follow-up, the lesions had flattened with softening of the skin. The patient reported his legs were smaller and he had bought a new pair of shoes at size 8.5 (Figure, C). He noted less pain and difficulty with walking. The circumference of the extremities was measured again (right ankle, 10.2 in; left ankle, 10 in; right and left mid-plantar feet, 10.5 in). The patient continued treatment and was followed for 3 months. At each visit, clinical improvement was noted as well as report of decreased pain while walking (Figure, D).
Pretibial myxedema is a known manifestation of Graves disease that almost always occurs in the presence of Graves ophthalmopathy. Pretibial myxedema occurs in 0.5% to 4.3% of patients with Graves disease and variably manifests as diffuse nonpitting edema or localized, waxy, indurated plaques or nodules.1,2
The proposed pathogenesis of PM is that autoantibodies directed against the thyroid receptors cross-react with the fibroblasts of the skin,2,3 which stimulates the fibroblasts to produce high amounts of glycosaminoglycans, especially hyaluronic acid, in the dermis and subcutis of the pretibial area. It is not known why there is a predilection for the anterior shins, but mechanical factors and dependent position (ie, leg position is lower than the level of the heart) may be involved.4
The mainstay of treatment for PM is topical and intralesional corticosteroids, which may have a benefit in mild to moderate disease; however, in cases of severe disease that is refractory to intralesional and topical corticosteroids under occlusion, more aggressive treatment is required. Systemic immunosuppressants such as cyclosporine, azathioprine, and corticosteroids have proven useful in some but not all cases.5,6
Our patient did not respond to treatment with systemic and intralesional corticosteroids, cyclosporine, or azathioprine before he presented to our clinic; however, the lesions were dramatically improved after 3 weeks of treatment with pentoxifylline, intralesional and topical corticosteroids under occlusion, short-stretch bandages, and compression stockings.
Pentoxifylline inhibits the proliferation and glycosaminoglycan synthesis of cultured fibroblasts derived from patients with Graves ophthalmology and PM.7 It has been shown to reduce thickness of skin lesions when used in combination with topical or intralesional steroids.3,8 Corticosteroids are thought to block fibroblast-mediated glycosaminoglycan production.3,9 The deposition of mucin, which is comprised of glycosaminoglycans, expands the dermal tissue and causes fluid to accumulate; it also causes compression of dermal lymphatics, worsening the dermal edema. Because fluid accumulates, the use of short-stretch bandages and compression stockings may provide additional benefit, as was seen in our patient, whose shoe size decreased from a 13 to an 8.5 within 3 weeks of treatment.
In conclusion, the combination of pentoxifylline, intralesional and topical corticosteroids under occlusion, short-stretch bandages, and compression garments can cause substantial improvement in severe PM refractory to systemic immunosuppressants.
To the Editor:
A 55-year-old man with a history of Graves disease treated with radioactive iodine and Graves ophthalmopathy was referred to our dermatology clinic by his endocrinologist with a 2-year history of severe pretibial myxedema (PM) that had failed treatment with systemic immunosuppressants after diagnosis by an outside dermatologist in the United Kingdom approximately 2 years prior. In addition to burning pain and difficulty walking associated with progressive “enlarging” of the lower legs and feet (Figure, A and B), the patient reported that he consistently had to find larger shoes (size 13 at the current presentation). His medications included gabapentin for foot pain and levothyroxine for hypothyroidism.
Physical examination revealed diffuse, waxy, indurated, flesh-colored and erythematous plaques and nodules with a peau d’orange appearance on the dorsal feet, ankles, and lower legs. Laboratory evaluation revealed a thyroid stimulating immunoglobulin level of 617% (reference range, <140%) and mild anemia. His thyroid stimulating hormone and free T4 levels, a comprehensive metabolic panel, and lipid panel were all within reference range.
Treatment with oral, intravenous, and intralesional steroids; cyclosporine; and azathioprine were tried prior to presentation to our clinic with no improvement. The patient was started on pentoxifylline (400 mg 3 times daily), intralesional triamcinolone acetonide (5 mg/mL every 3–4 weeks), clobetasol propionate ointment 0.05% under occlusion twice daily, short-stretch bandages, and compression stockings (20–30 mm Hg). The baseline circumference of the extremities also were measured (right ankle, 12 in; left ankle, 11.5 in; right and left mid-plantar feet, 12 in).
At 3-week follow-up, the lesions had flattened with softening of the skin. The patient reported his legs were smaller and he had bought a new pair of shoes at size 8.5 (Figure, C). He noted less pain and difficulty with walking. The circumference of the extremities was measured again (right ankle, 10.2 in; left ankle, 10 in; right and left mid-plantar feet, 10.5 in). The patient continued treatment and was followed for 3 months. At each visit, clinical improvement was noted as well as report of decreased pain while walking (Figure, D).
Pretibial myxedema is a known manifestation of Graves disease that almost always occurs in the presence of Graves ophthalmopathy. Pretibial myxedema occurs in 0.5% to 4.3% of patients with Graves disease and variably manifests as diffuse nonpitting edema or localized, waxy, indurated plaques or nodules.1,2
The proposed pathogenesis of PM is that autoantibodies directed against the thyroid receptors cross-react with the fibroblasts of the skin,2,3 which stimulates the fibroblasts to produce high amounts of glycosaminoglycans, especially hyaluronic acid, in the dermis and subcutis of the pretibial area. It is not known why there is a predilection for the anterior shins, but mechanical factors and dependent position (ie, leg position is lower than the level of the heart) may be involved.4
The mainstay of treatment for PM is topical and intralesional corticosteroids, which may have a benefit in mild to moderate disease; however, in cases of severe disease that is refractory to intralesional and topical corticosteroids under occlusion, more aggressive treatment is required. Systemic immunosuppressants such as cyclosporine, azathioprine, and corticosteroids have proven useful in some but not all cases.5,6
Our patient did not respond to treatment with systemic and intralesional corticosteroids, cyclosporine, or azathioprine before he presented to our clinic; however, the lesions were dramatically improved after 3 weeks of treatment with pentoxifylline, intralesional and topical corticosteroids under occlusion, short-stretch bandages, and compression stockings.
Pentoxifylline inhibits the proliferation and glycosaminoglycan synthesis of cultured fibroblasts derived from patients with Graves ophthalmology and PM.7 It has been shown to reduce thickness of skin lesions when used in combination with topical or intralesional steroids.3,8 Corticosteroids are thought to block fibroblast-mediated glycosaminoglycan production.3,9 The deposition of mucin, which is comprised of glycosaminoglycans, expands the dermal tissue and causes fluid to accumulate; it also causes compression of dermal lymphatics, worsening the dermal edema. Because fluid accumulates, the use of short-stretch bandages and compression stockings may provide additional benefit, as was seen in our patient, whose shoe size decreased from a 13 to an 8.5 within 3 weeks of treatment.
In conclusion, the combination of pentoxifylline, intralesional and topical corticosteroids under occlusion, short-stretch bandages, and compression garments can cause substantial improvement in severe PM refractory to systemic immunosuppressants.
- Susser WS, Heermans AG, Chapman MS, et al. Elephantiasic pretibial myxedema: a novel treatment for an uncommon disorder. J Am Acad Dermatol. 2002;46:723-726.
- Kriss J. Pathogenesis and treatment of pretibial myxedema. Endocrinol Metab Clin North Am. 1987;16:409-415.
- Pineda AM, Tianco EA, Tan JB, et al. Oral pentoxifylline and topical clobetasol propionate ointment in the treatment of pretibial myxoedema, with concomitant improvement of Graves’ ophthalmopathy. J Eur Acad Dermatol Venereol. 2007; 21:1441-1443.
- Fatourechi V. Pretibial myxedema. Am J Clin Dermatol. 2005;6:295-309.
- Benoit FL, Greenspan FS. Corticoid therapy for pretibial myxedema: observations on the long-acting thyroid stimulator. Ann Intern Med. 1967;66:711-720.
- Hanke CW, Bergfeld WF, Guirguis MN, et al. Pretibial myxedema (elephantiasis form): treatment with cytotoxic therapy. Cleve Clin Q. 1983;50:183-188.
- Chang CC, Chang TC, Kao SC, et al. Pentoxifylline inhibits the proliferation and glycosaminoglycan synthesis of cultured fibroblasts derived from patients with Graves’ ophthalmopathy and pretibial myxoedema. Acta Endocrinol (Copenh). 1993;129:322-327.
- Engin B, Gümüs¸el M, Ozdemir M, et al. Successful combined pentoxifylline and intralesional triamcinolone acetonide treatment of severe pretibial myxedema. Dermatol Online J. 2007;13:16.
- Lang PG, Sisson JC, Lynch PJ. Intralesional triamcinolone therapy for pretibial myxedema. Arch Dermatol. 1975;111:197-202.
- Susser WS, Heermans AG, Chapman MS, et al. Elephantiasic pretibial myxedema: a novel treatment for an uncommon disorder. J Am Acad Dermatol. 2002;46:723-726.
- Kriss J. Pathogenesis and treatment of pretibial myxedema. Endocrinol Metab Clin North Am. 1987;16:409-415.
- Pineda AM, Tianco EA, Tan JB, et al. Oral pentoxifylline and topical clobetasol propionate ointment in the treatment of pretibial myxoedema, with concomitant improvement of Graves’ ophthalmopathy. J Eur Acad Dermatol Venereol. 2007; 21:1441-1443.
- Fatourechi V. Pretibial myxedema. Am J Clin Dermatol. 2005;6:295-309.
- Benoit FL, Greenspan FS. Corticoid therapy for pretibial myxedema: observations on the long-acting thyroid stimulator. Ann Intern Med. 1967;66:711-720.
- Hanke CW, Bergfeld WF, Guirguis MN, et al. Pretibial myxedema (elephantiasis form): treatment with cytotoxic therapy. Cleve Clin Q. 1983;50:183-188.
- Chang CC, Chang TC, Kao SC, et al. Pentoxifylline inhibits the proliferation and glycosaminoglycan synthesis of cultured fibroblasts derived from patients with Graves’ ophthalmopathy and pretibial myxoedema. Acta Endocrinol (Copenh). 1993;129:322-327.
- Engin B, Gümüs¸el M, Ozdemir M, et al. Successful combined pentoxifylline and intralesional triamcinolone acetonide treatment of severe pretibial myxedema. Dermatol Online J. 2007;13:16.
- Lang PG, Sisson JC, Lynch PJ. Intralesional triamcinolone therapy for pretibial myxedema. Arch Dermatol. 1975;111:197-202.
Practice Points
- Pretibial myxedema (PM) is a known manifestation of Graves disease that almost always occurs in the presence of Graves ophthalmopathy.
- The proposed pathogenesis of PM is cross-reaction of autoantibodies directed against the thyroid receptors with the fibroblasts of the skin. It is not known why there is a predilection for the anterior shins, but mechanical factors and dependent position may be involved.
- The mainstay of treatment for PM is topical and intralesional corticosteroids, which may have a benefit in mild to moderate disease; however, in cases of severe disease that is refractory to intralesional and topical corticosteroids under occlusion, more aggressive treatment is required.
Cancer Care Coordination Perspectives of Veteran Patients with Cancer
Background: Coordinating cancer care can prove especially challenging because of the complexity of both the disease and its treatment. Typically, the care of cancer patients involves multiple types of therapies and providers (surgery, radiation therapy, chemotherapy) and ongoing treatment of cancer and other health conditions. Cancer care coordination depends upon effective, regular communication among physicians, support staff, and the patient. The objective of this study is to explore veteran patients’ experiences of cancer care coordination in order to develop a deeper understanding of the issues veterans consider important and actionable.
Methods: Semi-structured interviews were conducted among patients diagnosed with cancer types and stages that commonly receive inter-disciplinary care (eg, colorectal [stage II and up], prostate [high risk], head and neck [all stages], and lung [all stages] cancer) were eligible to participate in the study. The constant comparison technique was used to identify emerging themes.
Results: Twenty-five veteran cancer patients participated in this study. Our analysis identified four general categories representing different parts of the trajectory of the patient cancer care experience in need of coordination. Each phase had a distinct set of needs and challenges. Diagnosis: After receiving a diagnosis of cancer, Veterans reported initial feelings of shock and fear. Pre-Treatment: This phase was characterized as busy and chaotic, consisting of many appointments in different locations, and ultimately left many veterans feeling a lack of control. Onset of Treatment: Uncertainty about what to expect when receiving advanced treatments, like radiation and chemotherapy, was often exacerbated by poor provider-provider communication issues. Ongoing Treatment: As treatment progressed, many veterans experienced a growing familiarity with their routine, and simultaneously, began to regain a sense of control. Care Team: Nurse navigators were considered vital to cancer care coordination. Veterans valued honesty and transparency from their providers which built a sense of trust.
Conclusion: Veterans expressed a need to have care coordination needs and steps more explicitly addressed early, as well as active mechanisms to meet those needs. The patient experience of coordination gradually improved over the course of the care trajectory, often facilitated by relationships fostered with members of the healthcare team.
Background: Coordinating cancer care can prove especially challenging because of the complexity of both the disease and its treatment. Typically, the care of cancer patients involves multiple types of therapies and providers (surgery, radiation therapy, chemotherapy) and ongoing treatment of cancer and other health conditions. Cancer care coordination depends upon effective, regular communication among physicians, support staff, and the patient. The objective of this study is to explore veteran patients’ experiences of cancer care coordination in order to develop a deeper understanding of the issues veterans consider important and actionable.
Methods: Semi-structured interviews were conducted among patients diagnosed with cancer types and stages that commonly receive inter-disciplinary care (eg, colorectal [stage II and up], prostate [high risk], head and neck [all stages], and lung [all stages] cancer) were eligible to participate in the study. The constant comparison technique was used to identify emerging themes.
Results: Twenty-five veteran cancer patients participated in this study. Our analysis identified four general categories representing different parts of the trajectory of the patient cancer care experience in need of coordination. Each phase had a distinct set of needs and challenges. Diagnosis: After receiving a diagnosis of cancer, Veterans reported initial feelings of shock and fear. Pre-Treatment: This phase was characterized as busy and chaotic, consisting of many appointments in different locations, and ultimately left many veterans feeling a lack of control. Onset of Treatment: Uncertainty about what to expect when receiving advanced treatments, like radiation and chemotherapy, was often exacerbated by poor provider-provider communication issues. Ongoing Treatment: As treatment progressed, many veterans experienced a growing familiarity with their routine, and simultaneously, began to regain a sense of control. Care Team: Nurse navigators were considered vital to cancer care coordination. Veterans valued honesty and transparency from their providers which built a sense of trust.
Conclusion: Veterans expressed a need to have care coordination needs and steps more explicitly addressed early, as well as active mechanisms to meet those needs. The patient experience of coordination gradually improved over the course of the care trajectory, often facilitated by relationships fostered with members of the healthcare team.
Background: Coordinating cancer care can prove especially challenging because of the complexity of both the disease and its treatment. Typically, the care of cancer patients involves multiple types of therapies and providers (surgery, radiation therapy, chemotherapy) and ongoing treatment of cancer and other health conditions. Cancer care coordination depends upon effective, regular communication among physicians, support staff, and the patient. The objective of this study is to explore veteran patients’ experiences of cancer care coordination in order to develop a deeper understanding of the issues veterans consider important and actionable.
Methods: Semi-structured interviews were conducted among patients diagnosed with cancer types and stages that commonly receive inter-disciplinary care (eg, colorectal [stage II and up], prostate [high risk], head and neck [all stages], and lung [all stages] cancer) were eligible to participate in the study. The constant comparison technique was used to identify emerging themes.
Results: Twenty-five veteran cancer patients participated in this study. Our analysis identified four general categories representing different parts of the trajectory of the patient cancer care experience in need of coordination. Each phase had a distinct set of needs and challenges. Diagnosis: After receiving a diagnosis of cancer, Veterans reported initial feelings of shock and fear. Pre-Treatment: This phase was characterized as busy and chaotic, consisting of many appointments in different locations, and ultimately left many veterans feeling a lack of control. Onset of Treatment: Uncertainty about what to expect when receiving advanced treatments, like radiation and chemotherapy, was often exacerbated by poor provider-provider communication issues. Ongoing Treatment: As treatment progressed, many veterans experienced a growing familiarity with their routine, and simultaneously, began to regain a sense of control. Care Team: Nurse navigators were considered vital to cancer care coordination. Veterans valued honesty and transparency from their providers which built a sense of trust.
Conclusion: Veterans expressed a need to have care coordination needs and steps more explicitly addressed early, as well as active mechanisms to meet those needs. The patient experience of coordination gradually improved over the course of the care trajectory, often facilitated by relationships fostered with members of the healthcare team.
Decreasing Chemotherapy Administration Wait Time for Veterans with Cancer: A Minneapolis VA Medical Center Quality Improvement Project
Background: Cancer diagnosis is a devastating and painful process for patients and their families, resulting in significant stress and uncertainty. Chemotherapy treatments may provide a cure, control or palliate symptoms caused by cancer. However, delivery of chemotherapy in outpatient clinics is challenging and timeconsuming. Long wait is a common patient complaint, affects work-flow and chair time usage, increases costs, and compromises safety. We sought to review our system and implement changes that may result in decrease wait time.
Methods: Utilizing the Institute for Healthcare Improvement (IHI) model, the plan-do-study-act (PDSA) method to test and implement changes, we established a preintervention Ishikawa diagram over a 4 weeks period to study the process and determine cause of delay. Changes were implemented in a stepwise fashion, assess for improvement and revised our process over another 4 week period. We collect and analyze data for a total of 2 months. The objective of the study was to decrease wait-time to initiate chemotherapy treatment from the end of clinic visit to start of chemotherapy infusion by 20-30 minutes for 50% of patients in the oncology clinic over a three-month period.
Results: Pre-intervention data was collected on 245 patients. 55% (n=136) of these patients waited an average of 90 minutes and 45% (n=110) waited an average of 42 minutes from check-in to infusion clinic to start of chemotherapy. Identified barriers causing delayed chemotherapy administration included no consent, no prior authorization, unwritten/unsigned orders, pharmacy release delay, incomplete required labs, delay drug delivery from pharmacy, and difficulty with IV access. After the first cycle of PDSA, post-intervention data reveal a small improvement. 52% (n=199) patients waited an average of 87 minutes and 48% (n=183) average wait was 41 minutes.
Conclusions: By utilizing the PDSA cycle to test the modification of the revised workflow system and eliminate barriers to release of chemotherapy we could potentially reduce wait times for patient receiving chemotherapy at the Minneapolis VA. Updated data will be presented at the AVAHO Annual Meeting.
Background: Cancer diagnosis is a devastating and painful process for patients and their families, resulting in significant stress and uncertainty. Chemotherapy treatments may provide a cure, control or palliate symptoms caused by cancer. However, delivery of chemotherapy in outpatient clinics is challenging and timeconsuming. Long wait is a common patient complaint, affects work-flow and chair time usage, increases costs, and compromises safety. We sought to review our system and implement changes that may result in decrease wait time.
Methods: Utilizing the Institute for Healthcare Improvement (IHI) model, the plan-do-study-act (PDSA) method to test and implement changes, we established a preintervention Ishikawa diagram over a 4 weeks period to study the process and determine cause of delay. Changes were implemented in a stepwise fashion, assess for improvement and revised our process over another 4 week period. We collect and analyze data for a total of 2 months. The objective of the study was to decrease wait-time to initiate chemotherapy treatment from the end of clinic visit to start of chemotherapy infusion by 20-30 minutes for 50% of patients in the oncology clinic over a three-month period.
Results: Pre-intervention data was collected on 245 patients. 55% (n=136) of these patients waited an average of 90 minutes and 45% (n=110) waited an average of 42 minutes from check-in to infusion clinic to start of chemotherapy. Identified barriers causing delayed chemotherapy administration included no consent, no prior authorization, unwritten/unsigned orders, pharmacy release delay, incomplete required labs, delay drug delivery from pharmacy, and difficulty with IV access. After the first cycle of PDSA, post-intervention data reveal a small improvement. 52% (n=199) patients waited an average of 87 minutes and 48% (n=183) average wait was 41 minutes.
Conclusions: By utilizing the PDSA cycle to test the modification of the revised workflow system and eliminate barriers to release of chemotherapy we could potentially reduce wait times for patient receiving chemotherapy at the Minneapolis VA. Updated data will be presented at the AVAHO Annual Meeting.
Background: Cancer diagnosis is a devastating and painful process for patients and their families, resulting in significant stress and uncertainty. Chemotherapy treatments may provide a cure, control or palliate symptoms caused by cancer. However, delivery of chemotherapy in outpatient clinics is challenging and timeconsuming. Long wait is a common patient complaint, affects work-flow and chair time usage, increases costs, and compromises safety. We sought to review our system and implement changes that may result in decrease wait time.
Methods: Utilizing the Institute for Healthcare Improvement (IHI) model, the plan-do-study-act (PDSA) method to test and implement changes, we established a preintervention Ishikawa diagram over a 4 weeks period to study the process and determine cause of delay. Changes were implemented in a stepwise fashion, assess for improvement and revised our process over another 4 week period. We collect and analyze data for a total of 2 months. The objective of the study was to decrease wait-time to initiate chemotherapy treatment from the end of clinic visit to start of chemotherapy infusion by 20-30 minutes for 50% of patients in the oncology clinic over a three-month period.
Results: Pre-intervention data was collected on 245 patients. 55% (n=136) of these patients waited an average of 90 minutes and 45% (n=110) waited an average of 42 minutes from check-in to infusion clinic to start of chemotherapy. Identified barriers causing delayed chemotherapy administration included no consent, no prior authorization, unwritten/unsigned orders, pharmacy release delay, incomplete required labs, delay drug delivery from pharmacy, and difficulty with IV access. After the first cycle of PDSA, post-intervention data reveal a small improvement. 52% (n=199) patients waited an average of 87 minutes and 48% (n=183) average wait was 41 minutes.
Conclusions: By utilizing the PDSA cycle to test the modification of the revised workflow system and eliminate barriers to release of chemotherapy we could potentially reduce wait times for patient receiving chemotherapy at the Minneapolis VA. Updated data will be presented at the AVAHO Annual Meeting.
The Impact of Using Ideal Body Weight for Dosing of Intravenous Immune Globulin on Potential Grams Averted
Purpose: The primary objective of this study was to evaluate the total potential grams of intravenous immune globulin (IVIG) averted using ideal body weight (IBW) versus actual body weight (ABW) for dosing calculations. The secondary objectives assessed the indication for use of IVIG, change in serum immunoglobulin G (IgG) levels, and potential cost savings of using IBW to dose IVIG as an alternative to ABW.
Background: Dosing of IVIG in clinical studies is based on ABW. Increasing evidence suggests it is more appropriate to dose IVIG using IBW in all patients, given it primarily distributes throughout intravascular and extravascular fluid compartments. Recent studies have demonstrated benefit for the use of IBW for IVIG dosing in regard to outcomes such as grams of drug averted, guideline compliance, and changes in serum IgG levels. This study aimed to add to the body of literature supporting use of IBW for dosing of IVIG.
Methods: A retrospective chart review was conducted for patients administered IVIG therapy between May 1, 2018 and November 30, 2018. IBW was calculated per patient using the Devine equation.
Data Anaysis: Descriptive statistics were used to assess all primary and secondary objectives. This included examining medians and interquartile ranges for the primary objective as well as potential cost savings per dose.
Results: In regard to the primary objective, the total potential grams of IVIG averted was 965 grams. In terms per dose, a median of 45 grams of IVIG per patient could have been averted, with a range from 0 to 75 grams. In regard to secondary objectives, the total potential cost savings was $41,038.57. In terms per dose, a median of $252.43 per patient could have been avoided, with a range from 0 to $634.51. IVIG was most commonly being prescribed for primary humoral immunodeficiency states and chronic lymphocytic leukemia.
Implications: This data may help guide the decision to transition to utilization of IBW for IVIG dosing. In addition, it may give further insight regarding the need to create a pharmacy-to-dose protocol for IVIG.
Purpose: The primary objective of this study was to evaluate the total potential grams of intravenous immune globulin (IVIG) averted using ideal body weight (IBW) versus actual body weight (ABW) for dosing calculations. The secondary objectives assessed the indication for use of IVIG, change in serum immunoglobulin G (IgG) levels, and potential cost savings of using IBW to dose IVIG as an alternative to ABW.
Background: Dosing of IVIG in clinical studies is based on ABW. Increasing evidence suggests it is more appropriate to dose IVIG using IBW in all patients, given it primarily distributes throughout intravascular and extravascular fluid compartments. Recent studies have demonstrated benefit for the use of IBW for IVIG dosing in regard to outcomes such as grams of drug averted, guideline compliance, and changes in serum IgG levels. This study aimed to add to the body of literature supporting use of IBW for dosing of IVIG.
Methods: A retrospective chart review was conducted for patients administered IVIG therapy between May 1, 2018 and November 30, 2018. IBW was calculated per patient using the Devine equation.
Data Anaysis: Descriptive statistics were used to assess all primary and secondary objectives. This included examining medians and interquartile ranges for the primary objective as well as potential cost savings per dose.
Results: In regard to the primary objective, the total potential grams of IVIG averted was 965 grams. In terms per dose, a median of 45 grams of IVIG per patient could have been averted, with a range from 0 to 75 grams. In regard to secondary objectives, the total potential cost savings was $41,038.57. In terms per dose, a median of $252.43 per patient could have been avoided, with a range from 0 to $634.51. IVIG was most commonly being prescribed for primary humoral immunodeficiency states and chronic lymphocytic leukemia.
Implications: This data may help guide the decision to transition to utilization of IBW for IVIG dosing. In addition, it may give further insight regarding the need to create a pharmacy-to-dose protocol for IVIG.
Purpose: The primary objective of this study was to evaluate the total potential grams of intravenous immune globulin (IVIG) averted using ideal body weight (IBW) versus actual body weight (ABW) for dosing calculations. The secondary objectives assessed the indication for use of IVIG, change in serum immunoglobulin G (IgG) levels, and potential cost savings of using IBW to dose IVIG as an alternative to ABW.
Background: Dosing of IVIG in clinical studies is based on ABW. Increasing evidence suggests it is more appropriate to dose IVIG using IBW in all patients, given it primarily distributes throughout intravascular and extravascular fluid compartments. Recent studies have demonstrated benefit for the use of IBW for IVIG dosing in regard to outcomes such as grams of drug averted, guideline compliance, and changes in serum IgG levels. This study aimed to add to the body of literature supporting use of IBW for dosing of IVIG.
Methods: A retrospective chart review was conducted for patients administered IVIG therapy between May 1, 2018 and November 30, 2018. IBW was calculated per patient using the Devine equation.
Data Anaysis: Descriptive statistics were used to assess all primary and secondary objectives. This included examining medians and interquartile ranges for the primary objective as well as potential cost savings per dose.
Results: In regard to the primary objective, the total potential grams of IVIG averted was 965 grams. In terms per dose, a median of 45 grams of IVIG per patient could have been averted, with a range from 0 to 75 grams. In regard to secondary objectives, the total potential cost savings was $41,038.57. In terms per dose, a median of $252.43 per patient could have been avoided, with a range from 0 to $634.51. IVIG was most commonly being prescribed for primary humoral immunodeficiency states and chronic lymphocytic leukemia.
Implications: This data may help guide the decision to transition to utilization of IBW for IVIG dosing. In addition, it may give further insight regarding the need to create a pharmacy-to-dose protocol for IVIG.