Dear Colleagues,

It doesn’t seem possible, but I have just completed the first quarter of my term as your 79th President and recently returned from chairing my first board meeting – a scary experience to be sure. All in all, it went well. We officially offered Steve Welch the position of Executive Vice President, thereby ushering in one of our own to lead the organization. Steve has successfully served as CHEST’s interim EVP/CEO since May 2016, after 22 years of service with this organization, most recently as Senior Vice President of Publications and Digital Content. I am utterly and completely confident in our choice and want you to know he has the full backing of the board, the Past Presidents, and nearly every doctor he has come in contact with.

Gerard A. Silvestri, MD, MS, FCCP

President

Dear Colleagues,

It doesn’t seem possible, but I have just completed the first quarter of my term as your 79th President and recently returned from chairing my first board meeting – a scary experience to be sure. All in all, it went well. We officially offered Steve Welch the position of Executive Vice President, thereby ushering in one of our own to lead the organization. Steve has successfully served as CHEST’s interim EVP/CEO since May 2016, after 22 years of service with this organization, most recently as Senior Vice President of Publications and Digital Content. I am utterly and completely confident in our choice and want you to know he has the full backing of the board, the Past Presidents, and nearly every doctor he has come in contact with.

Gerard A. Silvestri, MD, MS, FCCP

President

Dear Colleagues,

It doesn’t seem possible, but I have just completed the first quarter of my term as your 79th President and recently returned from chairing my first board meeting – a scary experience to be sure. All in all, it went well. We officially offered Steve Welch the position of Executive Vice President, thereby ushering in one of our own to lead the organization. Steve has successfully served as CHEST’s interim EVP/CEO since May 2016, after 22 years of service with this organization, most recently as Senior Vice President of Publications and Digital Content. I am utterly and completely confident in our choice and want you to know he has the full backing of the board, the Past Presidents, and nearly every doctor he has come in contact with.

Gerard A. Silvestri, MD, MS, FCCP

President

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

The title of the book, “Passion for Patients,” by Lee H. Beecher, MD, DLFAPA, FASAM, with writer Dave Racer, MLitt (St. Paul, Minn., Alethos Press, 2017), clearly represents Dr. Beecher’s approach to his professional life: His focal interest has been his patients ever since he went to medical school and started a very long and successful practice.

Dr. Beecher’s years of practice encompass many of the changes that the practice of medicine has seen in the last 50 years.

He attended medical school when an office was the place where a physician and his patients would get together to exchange thoughts, feelings, ideas, and plans so that they would eventually work together directly and unencumbered on the same concepts that they share and that they considered crucial to their relationship.

Shortly after Dr. Beecher graduated, Medicaid and Medicare came into medical practice, together with progressive limitations, threats, and a great many unwelcome interlopers, whose mission drastically changed the doctor-patient relationship. No matter how one examines the actions of the numerous new participants – be they auditors, insurance companies, employers, or money managers – one of their main missions was to modify, qualify, re-identify, and limit the interaction between the doctor and the patient.

Dr. Muñoz, a former president of the American Psychiatric Association, has written eight books and more than 200 articles about various aspects of psychiatry. He is a professor of psychiatry at the University of California, San Diego, and has a private practice. Dr. Muñoz and Dr. Beecher serve on the Editorial Advisory Board of Clinical Psychiatry News.

The title of the book, “Passion for Patients,” by Lee H. Beecher, MD, DLFAPA, FASAM, with writer Dave Racer, MLitt (St. Paul, Minn., Alethos Press, 2017), clearly represents Dr. Beecher’s approach to his professional life: His focal interest has been his patients ever since he went to medical school and started a very long and successful practice.

Dr. Beecher’s years of practice encompass many of the changes that the practice of medicine has seen in the last 50 years.

He attended medical school when an office was the place where a physician and his patients would get together to exchange thoughts, feelings, ideas, and plans so that they would eventually work together directly and unencumbered on the same concepts that they share and that they considered crucial to their relationship.

Shortly after Dr. Beecher graduated, Medicaid and Medicare came into medical practice, together with progressive limitations, threats, and a great many unwelcome interlopers, whose mission drastically changed the doctor-patient relationship. No matter how one examines the actions of the numerous new participants – be they auditors, insurance companies, employers, or money managers – one of their main missions was to modify, qualify, re-identify, and limit the interaction between the doctor and the patient.

Dr. Muñoz, a former president of the American Psychiatric Association, has written eight books and more than 200 articles about various aspects of psychiatry. He is a professor of psychiatry at the University of California, San Diego, and has a private practice. Dr. Muñoz and Dr. Beecher serve on the Editorial Advisory Board of Clinical Psychiatry News.

The title of the book, “Passion for Patients,” by Lee H. Beecher, MD, DLFAPA, FASAM, with writer Dave Racer, MLitt (St. Paul, Minn., Alethos Press, 2017), clearly represents Dr. Beecher’s approach to his professional life: His focal interest has been his patients ever since he went to medical school and started a very long and successful practice.

Dr. Beecher’s years of practice encompass many of the changes that the practice of medicine has seen in the last 50 years.

He attended medical school when an office was the place where a physician and his patients would get together to exchange thoughts, feelings, ideas, and plans so that they would eventually work together directly and unencumbered on the same concepts that they share and that they considered crucial to their relationship.

Shortly after Dr. Beecher graduated, Medicaid and Medicare came into medical practice, together with progressive limitations, threats, and a great many unwelcome interlopers, whose mission drastically changed the doctor-patient relationship. No matter how one examines the actions of the numerous new participants – be they auditors, insurance companies, employers, or money managers – one of their main missions was to modify, qualify, re-identify, and limit the interaction between the doctor and the patient.

Dr. Muñoz, a former president of the American Psychiatric Association, has written eight books and more than 200 articles about various aspects of psychiatry. He is a professor of psychiatry at the University of California, San Diego, and has a private practice. Dr. Muñoz and Dr. Beecher serve on the Editorial Advisory Board of Clinical Psychiatry News.

ORLANDO – The hair loss encounter – which can be challenging for both physicians and patients – should address the negative psychological effects of hair loss, including ways to camouflage hair loss, advised Adriana N. Schmidt, MD, a dermatologist in Santa Monica, Calif.

Dermatologists may spend so much time on the work-up – reviewing history regarding medication, lab values, and hair care practices – that they do not spend time to simply say to patients, “I want to help you feel better about yourself, and here’s how,” she said in a video interview at the annual meeting of the American Academy of Dermatology.

“What we can do is offer them a way to camouflage the hair loss,” Dr. Schmidt said. She shared tips that include creating a kit to keep in the office filled with lists of reputable hairpiece vendors and tattoo specialists in the community, as well as sample wigs, cosmetic powders, and other items to show to patients during hair loss consultations. She also offers thoughts on working with new hair styles and stylists to help improve the self-esteem of alopecia patients.

Dr. Schmidt had no relevant disclosures.

wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight

ORLANDO – The hair loss encounter – which can be challenging for both physicians and patients – should address the negative psychological effects of hair loss, including ways to camouflage hair loss, advised Adriana N. Schmidt, MD, a dermatologist in Santa Monica, Calif.

Dermatologists may spend so much time on the work-up – reviewing history regarding medication, lab values, and hair care practices – that they do not spend time to simply say to patients, “I want to help you feel better about yourself, and here’s how,” she said in a video interview at the annual meeting of the American Academy of Dermatology.

“What we can do is offer them a way to camouflage the hair loss,” Dr. Schmidt said. She shared tips that include creating a kit to keep in the office filled with lists of reputable hairpiece vendors and tattoo specialists in the community, as well as sample wigs, cosmetic powders, and other items to show to patients during hair loss consultations. She also offers thoughts on working with new hair styles and stylists to help improve the self-esteem of alopecia patients.

Dr. Schmidt had no relevant disclosures.

wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight

ORLANDO – The hair loss encounter – which can be challenging for both physicians and patients – should address the negative psychological effects of hair loss, including ways to camouflage hair loss, advised Adriana N. Schmidt, MD, a dermatologist in Santa Monica, Calif.

Dermatologists may spend so much time on the work-up – reviewing history regarding medication, lab values, and hair care practices – that they do not spend time to simply say to patients, “I want to help you feel better about yourself, and here’s how,” she said in a video interview at the annual meeting of the American Academy of Dermatology.

“What we can do is offer them a way to camouflage the hair loss,” Dr. Schmidt said. She shared tips that include creating a kit to keep in the office filled with lists of reputable hairpiece vendors and tattoo specialists in the community, as well as sample wigs, cosmetic powders, and other items to show to patients during hair loss consultations. She also offers thoughts on working with new hair styles and stylists to help improve the self-esteem of alopecia patients.

Dr. Schmidt had no relevant disclosures.

wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight

In 2012, 1.3 million veterans who were wounded in action had a severe service-connected disability—nearly triple the number in 2001 (482,000).¹ Given the increased number of wounded veterans, the need for caregivers also increased.

The act of caring for an individual with a chronic disability can be a daunting task for the caregiver. However, what is not so commonly recognized is the need for caregiver awareness of the available support resources. Caregivers who do not receive necessary support experience physical and emotional consequences that interfere with their ability to care for veterans with disabilities. Therefore, there is a significant need to provide adequate support for the caregiver to maintain optimum care of the veteran.²

Increased caregiver strain among family caregivers of veterans with long-term disabilities and their lack of knowledge of support resources is a clinical concern. A comprehensive review of the literature provided evidence that access and use of caregiver support resources improved caregiver quality of life.

The purpose of this project was to provide an educational intervention of caregiver resources that were available at the Durham VA Health Care System in North Carolina and in the surrounding community. The desired outcomes included (a) increasing the caregiver’s knowledge of resources available at the VA and within the community to decrease caregiver burden; and (b) assisting the caregiver in determining the best resources for the caregiver and patient. This project was deemed to be a quality improvement project and did not require institutional review board (IRB) approval.

Background

The term strain is used to describe the burden, trouble, or burnout that a caregiver encounters when caring for a person with a long-term illness or disability.³ Caregivers of veterans remain in their role longer and have a heavier burden of care than that of all other caregivers: 65% are in a high-burden caregiving situation compared with 31% nationally.⁴ The consequence of providing care without assistance has all the features of chronic stress.² Moreover, the decline of the caregiver’s health can significantly compromise the ability to provide care.³

Empirical observations of the negative health effects of caregiving noted over the past 2 decades have helped convince policymakers that supporting caregivers is an important public health issue.² To this end, Congress mandated legislation that required the VA to provide a support program for veteran caregivers. In May 2010, President Obama signed the Caregivers and Veterans Omnibus Health Services Act of 2010 into law.¹

Supporting Literature

The VA caregiver resource program offers a variety of support resources.¹ A better understanding of caregiver needs is necessary to provide the right support resources, improve the health and well-being of caregivers, and make decisions regarding individual caregiving situations.⁵ For example, respite care offers temporary or periodic relief from caregiving, allowing caregivers to attend to personal tasks, such as shopping, running errands, relaxing, and socializing. This service can increase the physical and mental well-being of the caregiver.⁶ Studies show that early use of support services is paramount in order for caregivers to receive the greatest positive impact.⁵

Chen and colleaguesconducted a study of 164 caregivers. The study showed that caregivers who received assistance with accessing the correct support resource exhibited considerably higher satisfaction with the services they received.⁷ Determining which support therapy was best for the caregiver and the patient for whom they were caring was seen as the initial step. Providing a tool that supplies all the information caregivers need as well as assisting them with accessing services more efficiently is beneficial.

The National Alliance for Caregiving conducted a study to evaluate the needs of caregivers of veterans of various conflicts.⁴ In the study, caregivers reported that a resource guide would be beneficial. Some of the services they wanted to include in the directory were VA disability benefits, respite care, home health care, hospice services, assisted living, rehabilitation therapies, caregiver support group information, and community resources.

Based on the literature, the author believed that better knowledge of support resources was needed for caregivers. The literature included detailed descriptions of how knowledge of support resources improved caregiver’s well-being by increasing his or her ability to cope with stress related to providing care. However, the literature could have provided a more elaborate discussion on this topic. That was the only weakness identified in each of the studies. Nonetheless, it was clearly noted that resource knowledge yielded a positive effect.

Methods

The project took place at the Durham VA Health Care System and was implemented from August 2015 to October 2015. The participants targeted were caregivers of veterans with disabilities who were considered the veteran’s primary caregiver. Participation was voluntary.

During the veteran’s clinic appointment, the caregiver was given an implied consent letter, pre- and postquestionnaire forms, and a caregiver resource manual. The manual included information on caregiver support resources at the Durham VA Health Care System and in the community (eg, adult day care centers; home-based primary care, hospice care, skilled care, and telehealth; homemaker and home health aide programs; respite care). Other information was provided, such as the Caregiver Support Program application process, contact names, numbers, and helpful websites. Before reading the manual, participants completed the prequestionnaire form and returned it the day of the veteran’s visit. After reading the manual, the caregiver was instructed to complete the postquestionnaire form.

The project coordinator (PC) collaborated with the Veteran Health Education coordinator in developing the caregiver resource manual and questionnaires to ensure that the material met the requirements set forth by the educational program within the Durham VA Health Care System. The PC also collaborated with the Caregiver Support Program subject experts, the chief and acting assistant chief of social work when formulating the contents of the manual and questionnaires. The questionnaires were used to assess the effectiveness of the manual.

The 3 questions on the prequestionnaire and 3 questions on the postquestionnaire were geared to measure the caregiver’s knowledge. There also were 4 questions on the postquestionnaire that were used to address manual revisions.

On the prequestionnaire form, the following questions were asked: (1) If you needed to find caregiver support resources, how much knowledge do you have finding the resources that fit your needs as well as the veteran’s needs? (2) Rate how aware you are with knowing what caregiver support resources are available at the VA and within the community; and (3) Would knowing which caregiver support resources to choose from at the VA and within the community decrease your stress level and give you “peace of mind?”

The same questions were asked postintervention, and the participants were asked to rate their knowledge after reviewing the manual. The participant’s responses on the questionnaires were measured using a 5-point Likert scale.

Participant Demographics

Demographic information was obtained from the cover letter distributed to each participant. The demographic information included age, gender, relationship to the veteran, and number of years to date in the current caregiving role. Participants eligible for inclusion in this project were primary caregivers of veterans with disabilities from all eras of conflict, aged ≥ 18 years.

Fifteen caregivers participated by returning the cover letter containing the implied consent, reading the manual, and completing the pre- and postquestionnaires. There was a wide age range of caregivers who participated, from 29 to 77 years. Of those who responded, there also was a wide range in time in their current caregiving role, ranging from 1 to 41 years. The mean number of years in the current caregiving role was 7 years.

Of the 15 participants, most were female spouses. There were no husbands who participated. The relative’s category included a cousin, a son, and a daughter. The “other” category included a son-in-law and a fiancé.

Data Analysis

Both outcomes were measured using the responses from questions 1 through 3 with the use of running a descriptive statistical analysis. In addition, a t test was used to determine statistical significance, set at α level < .05 of knowledge increase from pre- to postintervention data. Based on the facility, educational benchmarks were set at 80% with the 80% equal to 4 on the Likert scale. Therefore, 80% was the identified benchmark for this project. The goal was that > 70% of the participants would score 80% or better on the postquestionnaire.

Results

Both outcomes were met: (1) increasing the caregiver’s knowledge regarding resources available at the VA and within the community to decrease caregiver burden; and (2) assisting the caregiver in deciding which caregiver resources located in the manual were the right fit for the caregiver and the veteran for whom they were caring. The percentage of participants who scored 80% or better on the prequestionnaire was 54% (n = 8). The postquestionnaire outcomes were considered an improvement based on caregiver’s knowledge of support resources as well as whether the information in the manual decreased their stress level and gave them peace of mind. The intended outcome for the postquestionnaire was that > 70% of the participants would score ≥ 80% after the intervention. This goal was met as final results revealed 73% (n = 11) of the participants scored > 80% on the postquestionnaire.

The postresults supported that caregivers’ knowledge increased, they had peace of mind, and stress levels were decreased with the use of an educational intervention, a comprehensive Caregiver Resource Manual. The postquestionnaire revealed that all of the participants found the Caregiver Resource Manual easy to navigate, and 93% of participants found the Caregiver Resource Manual useful. Out of 15 participants, 8 provided comments. Seven provided positive comments, reporting that the information in the manual was interesting, the manual was simple/easy to read, and the outside resources listed were helpful.

The participant who provided a negative comment was one of the caregivers who did not meet the benchmark of 80% on the pre- or postquestionnaire. The participant was a 33-year-old wife of a veteran with disabilities who had been in the current caregiving role for 9 years. This participant reported that the Caregiver Resource Manual was not geared to younger caregivers, so she would not benefit from using the manual. This caregiver also was the only participant who reported that the Caregiver Resource Manual neither gave her peace of mind nor decreased her stress level.

Comments or suggestions would have been helpful from the other 8 individuals. Because it was not written in the IRB proposal to contact the participants other than to follow-up with telephone calls regarding unreturned questionnaires, no further contact was made with the participants.

Discussion

The preliminary success of this project suggests that there is a significant need for an educational conduit to ensure sufficient caregiver knowledge. Interprofessional collaborative efforts along with using information systems/technology to deliver the Caregiver Resource Manual electronically are important future consideration for improvement of the overall outcomes for a wide range of caregivers, veterans, and health care providers. Health care policy changes on the organizational level, systems level, and national level could further support caregivers of disabled veterans by enabling easy access to caregiver resources as a mandated practice.

Limitations

Limitations centered on the recruitment process. There were a total of 15 caregivers who participated. Although the participation did not meet the PC’s expectation, the final number of participants was adequate in obtaining data regarding evaluating the impact of this project.

Conclusion

The results of this project provided evidence that the Caregiver Resource Manual was effective. Caregivers gained a sense of knowledge and empowerment regarding available resources within the VA and the community. Providing the caregiver with peace of mind and improving the overall health and well-being of the caregiver and veteran were essential.

Moreover, just as the veterans who fought for freedom were equipped with full body armor to help protect them from the potential negative consequences of combat, caregivers who care for these brave soldiers are now equipped with a resource tool and a “full armor of knowledge” to care for their loved ones…our nation’s heroes…our veterans.

In 2012, 1.3 million veterans who were wounded in action had a severe service-connected disability—nearly triple the number in 2001 (482,000).¹ Given the increased number of wounded veterans, the need for caregivers also increased.

The act of caring for an individual with a chronic disability can be a daunting task for the caregiver. However, what is not so commonly recognized is the need for caregiver awareness of the available support resources. Caregivers who do not receive necessary support experience physical and emotional consequences that interfere with their ability to care for veterans with disabilities. Therefore, there is a significant need to provide adequate support for the caregiver to maintain optimum care of the veteran.²

Increased caregiver strain among family caregivers of veterans with long-term disabilities and their lack of knowledge of support resources is a clinical concern. A comprehensive review of the literature provided evidence that access and use of caregiver support resources improved caregiver quality of life.

The purpose of this project was to provide an educational intervention of caregiver resources that were available at the Durham VA Health Care System in North Carolina and in the surrounding community. The desired outcomes included (a) increasing the caregiver’s knowledge of resources available at the VA and within the community to decrease caregiver burden; and (b) assisting the caregiver in determining the best resources for the caregiver and patient. This project was deemed to be a quality improvement project and did not require institutional review board (IRB) approval.

Background

The term strain is used to describe the burden, trouble, or burnout that a caregiver encounters when caring for a person with a long-term illness or disability.³ Caregivers of veterans remain in their role longer and have a heavier burden of care than that of all other caregivers: 65% are in a high-burden caregiving situation compared with 31% nationally.⁴ The consequence of providing care without assistance has all the features of chronic stress.² Moreover, the decline of the caregiver’s health can significantly compromise the ability to provide care.³

Empirical observations of the negative health effects of caregiving noted over the past 2 decades have helped convince policymakers that supporting caregivers is an important public health issue.² To this end, Congress mandated legislation that required the VA to provide a support program for veteran caregivers. In May 2010, President Obama signed the Caregivers and Veterans Omnibus Health Services Act of 2010 into law.¹

Supporting Literature

The VA caregiver resource program offers a variety of support resources.¹ A better understanding of caregiver needs is necessary to provide the right support resources, improve the health and well-being of caregivers, and make decisions regarding individual caregiving situations.⁵ For example, respite care offers temporary or periodic relief from caregiving, allowing caregivers to attend to personal tasks, such as shopping, running errands, relaxing, and socializing. This service can increase the physical and mental well-being of the caregiver.⁶ Studies show that early use of support services is paramount in order for caregivers to receive the greatest positive impact.⁵

Chen and colleaguesconducted a study of 164 caregivers. The study showed that caregivers who received assistance with accessing the correct support resource exhibited considerably higher satisfaction with the services they received.⁷ Determining which support therapy was best for the caregiver and the patient for whom they were caring was seen as the initial step. Providing a tool that supplies all the information caregivers need as well as assisting them with accessing services more efficiently is beneficial.

The National Alliance for Caregiving conducted a study to evaluate the needs of caregivers of veterans of various conflicts.⁴ In the study, caregivers reported that a resource guide would be beneficial. Some of the services they wanted to include in the directory were VA disability benefits, respite care, home health care, hospice services, assisted living, rehabilitation therapies, caregiver support group information, and community resources.

Based on the literature, the author believed that better knowledge of support resources was needed for caregivers. The literature included detailed descriptions of how knowledge of support resources improved caregiver’s well-being by increasing his or her ability to cope with stress related to providing care. However, the literature could have provided a more elaborate discussion on this topic. That was the only weakness identified in each of the studies. Nonetheless, it was clearly noted that resource knowledge yielded a positive effect.

Methods

The project took place at the Durham VA Health Care System and was implemented from August 2015 to October 2015. The participants targeted were caregivers of veterans with disabilities who were considered the veteran’s primary caregiver. Participation was voluntary.

During the veteran’s clinic appointment, the caregiver was given an implied consent letter, pre- and postquestionnaire forms, and a caregiver resource manual. The manual included information on caregiver support resources at the Durham VA Health Care System and in the community (eg, adult day care centers; home-based primary care, hospice care, skilled care, and telehealth; homemaker and home health aide programs; respite care). Other information was provided, such as the Caregiver Support Program application process, contact names, numbers, and helpful websites. Before reading the manual, participants completed the prequestionnaire form and returned it the day of the veteran’s visit. After reading the manual, the caregiver was instructed to complete the postquestionnaire form.

The project coordinator (PC) collaborated with the Veteran Health Education coordinator in developing the caregiver resource manual and questionnaires to ensure that the material met the requirements set forth by the educational program within the Durham VA Health Care System. The PC also collaborated with the Caregiver Support Program subject experts, the chief and acting assistant chief of social work when formulating the contents of the manual and questionnaires. The questionnaires were used to assess the effectiveness of the manual.

The 3 questions on the prequestionnaire and 3 questions on the postquestionnaire were geared to measure the caregiver’s knowledge. There also were 4 questions on the postquestionnaire that were used to address manual revisions.

On the prequestionnaire form, the following questions were asked: (1) If you needed to find caregiver support resources, how much knowledge do you have finding the resources that fit your needs as well as the veteran’s needs? (2) Rate how aware you are with knowing what caregiver support resources are available at the VA and within the community; and (3) Would knowing which caregiver support resources to choose from at the VA and within the community decrease your stress level and give you “peace of mind?”

The same questions were asked postintervention, and the participants were asked to rate their knowledge after reviewing the manual. The participant’s responses on the questionnaires were measured using a 5-point Likert scale.

Participant Demographics

Demographic information was obtained from the cover letter distributed to each participant. The demographic information included age, gender, relationship to the veteran, and number of years to date in the current caregiving role. Participants eligible for inclusion in this project were primary caregivers of veterans with disabilities from all eras of conflict, aged ≥ 18 years.

Fifteen caregivers participated by returning the cover letter containing the implied consent, reading the manual, and completing the pre- and postquestionnaires. There was a wide age range of caregivers who participated, from 29 to 77 years. Of those who responded, there also was a wide range in time in their current caregiving role, ranging from 1 to 41 years. The mean number of years in the current caregiving role was 7 years.

Of the 15 participants, most were female spouses. There were no husbands who participated. The relative’s category included a cousin, a son, and a daughter. The “other” category included a son-in-law and a fiancé.

Data Analysis

Both outcomes were measured using the responses from questions 1 through 3 with the use of running a descriptive statistical analysis. In addition, a t test was used to determine statistical significance, set at α level < .05 of knowledge increase from pre- to postintervention data. Based on the facility, educational benchmarks were set at 80% with the 80% equal to 4 on the Likert scale. Therefore, 80% was the identified benchmark for this project. The goal was that > 70% of the participants would score 80% or better on the postquestionnaire.

Results

Both outcomes were met: (1) increasing the caregiver’s knowledge regarding resources available at the VA and within the community to decrease caregiver burden; and (2) assisting the caregiver in deciding which caregiver resources located in the manual were the right fit for the caregiver and the veteran for whom they were caring. The percentage of participants who scored 80% or better on the prequestionnaire was 54% (n = 8). The postquestionnaire outcomes were considered an improvement based on caregiver’s knowledge of support resources as well as whether the information in the manual decreased their stress level and gave them peace of mind. The intended outcome for the postquestionnaire was that > 70% of the participants would score ≥ 80% after the intervention. This goal was met as final results revealed 73% (n = 11) of the participants scored > 80% on the postquestionnaire.

The postresults supported that caregivers’ knowledge increased, they had peace of mind, and stress levels were decreased with the use of an educational intervention, a comprehensive Caregiver Resource Manual. The postquestionnaire revealed that all of the participants found the Caregiver Resource Manual easy to navigate, and 93% of participants found the Caregiver Resource Manual useful. Out of 15 participants, 8 provided comments. Seven provided positive comments, reporting that the information in the manual was interesting, the manual was simple/easy to read, and the outside resources listed were helpful.

The participant who provided a negative comment was one of the caregivers who did not meet the benchmark of 80% on the pre- or postquestionnaire. The participant was a 33-year-old wife of a veteran with disabilities who had been in the current caregiving role for 9 years. This participant reported that the Caregiver Resource Manual was not geared to younger caregivers, so she would not benefit from using the manual. This caregiver also was the only participant who reported that the Caregiver Resource Manual neither gave her peace of mind nor decreased her stress level.

Comments or suggestions would have been helpful from the other 8 individuals. Because it was not written in the IRB proposal to contact the participants other than to follow-up with telephone calls regarding unreturned questionnaires, no further contact was made with the participants.

Discussion

The preliminary success of this project suggests that there is a significant need for an educational conduit to ensure sufficient caregiver knowledge. Interprofessional collaborative efforts along with using information systems/technology to deliver the Caregiver Resource Manual electronically are important future consideration for improvement of the overall outcomes for a wide range of caregivers, veterans, and health care providers. Health care policy changes on the organizational level, systems level, and national level could further support caregivers of disabled veterans by enabling easy access to caregiver resources as a mandated practice.

Limitations

Limitations centered on the recruitment process. There were a total of 15 caregivers who participated. Although the participation did not meet the PC’s expectation, the final number of participants was adequate in obtaining data regarding evaluating the impact of this project.

Conclusion

The results of this project provided evidence that the Caregiver Resource Manual was effective. Caregivers gained a sense of knowledge and empowerment regarding available resources within the VA and the community. Providing the caregiver with peace of mind and improving the overall health and well-being of the caregiver and veteran were essential.

Moreover, just as the veterans who fought for freedom were equipped with full body armor to help protect them from the potential negative consequences of combat, caregivers who care for these brave soldiers are now equipped with a resource tool and a “full armor of knowledge” to care for their loved ones…our nation’s heroes…our veterans.

In 2012, 1.3 million veterans who were wounded in action had a severe service-connected disability—nearly triple the number in 2001 (482,000).¹ Given the increased number of wounded veterans, the need for caregivers also increased.

The act of caring for an individual with a chronic disability can be a daunting task for the caregiver. However, what is not so commonly recognized is the need for caregiver awareness of the available support resources. Caregivers who do not receive necessary support experience physical and emotional consequences that interfere with their ability to care for veterans with disabilities. Therefore, there is a significant need to provide adequate support for the caregiver to maintain optimum care of the veteran.²

Increased caregiver strain among family caregivers of veterans with long-term disabilities and their lack of knowledge of support resources is a clinical concern. A comprehensive review of the literature provided evidence that access and use of caregiver support resources improved caregiver quality of life.

The purpose of this project was to provide an educational intervention of caregiver resources that were available at the Durham VA Health Care System in North Carolina and in the surrounding community. The desired outcomes included (a) increasing the caregiver’s knowledge of resources available at the VA and within the community to decrease caregiver burden; and (b) assisting the caregiver in determining the best resources for the caregiver and patient. This project was deemed to be a quality improvement project and did not require institutional review board (IRB) approval.

Background

The term strain is used to describe the burden, trouble, or burnout that a caregiver encounters when caring for a person with a long-term illness or disability.³ Caregivers of veterans remain in their role longer and have a heavier burden of care than that of all other caregivers: 65% are in a high-burden caregiving situation compared with 31% nationally.⁴ The consequence of providing care without assistance has all the features of chronic stress.² Moreover, the decline of the caregiver’s health can significantly compromise the ability to provide care.³

Empirical observations of the negative health effects of caregiving noted over the past 2 decades have helped convince policymakers that supporting caregivers is an important public health issue.² To this end, Congress mandated legislation that required the VA to provide a support program for veteran caregivers. In May 2010, President Obama signed the Caregivers and Veterans Omnibus Health Services Act of 2010 into law.¹

Supporting Literature

The VA caregiver resource program offers a variety of support resources.¹ A better understanding of caregiver needs is necessary to provide the right support resources, improve the health and well-being of caregivers, and make decisions regarding individual caregiving situations.⁵ For example, respite care offers temporary or periodic relief from caregiving, allowing caregivers to attend to personal tasks, such as shopping, running errands, relaxing, and socializing. This service can increase the physical and mental well-being of the caregiver.⁶ Studies show that early use of support services is paramount in order for caregivers to receive the greatest positive impact.⁵

Chen and colleaguesconducted a study of 164 caregivers. The study showed that caregivers who received assistance with accessing the correct support resource exhibited considerably higher satisfaction with the services they received.⁷ Determining which support therapy was best for the caregiver and the patient for whom they were caring was seen as the initial step. Providing a tool that supplies all the information caregivers need as well as assisting them with accessing services more efficiently is beneficial.

The National Alliance for Caregiving conducted a study to evaluate the needs of caregivers of veterans of various conflicts.⁴ In the study, caregivers reported that a resource guide would be beneficial. Some of the services they wanted to include in the directory were VA disability benefits, respite care, home health care, hospice services, assisted living, rehabilitation therapies, caregiver support group information, and community resources.

Based on the literature, the author believed that better knowledge of support resources was needed for caregivers. The literature included detailed descriptions of how knowledge of support resources improved caregiver’s well-being by increasing his or her ability to cope with stress related to providing care. However, the literature could have provided a more elaborate discussion on this topic. That was the only weakness identified in each of the studies. Nonetheless, it was clearly noted that resource knowledge yielded a positive effect.

Methods

The project took place at the Durham VA Health Care System and was implemented from August 2015 to October 2015. The participants targeted were caregivers of veterans with disabilities who were considered the veteran’s primary caregiver. Participation was voluntary.

During the veteran’s clinic appointment, the caregiver was given an implied consent letter, pre- and postquestionnaire forms, and a caregiver resource manual. The manual included information on caregiver support resources at the Durham VA Health Care System and in the community (eg, adult day care centers; home-based primary care, hospice care, skilled care, and telehealth; homemaker and home health aide programs; respite care). Other information was provided, such as the Caregiver Support Program application process, contact names, numbers, and helpful websites. Before reading the manual, participants completed the prequestionnaire form and returned it the day of the veteran’s visit. After reading the manual, the caregiver was instructed to complete the postquestionnaire form.

The project coordinator (PC) collaborated with the Veteran Health Education coordinator in developing the caregiver resource manual and questionnaires to ensure that the material met the requirements set forth by the educational program within the Durham VA Health Care System. The PC also collaborated with the Caregiver Support Program subject experts, the chief and acting assistant chief of social work when formulating the contents of the manual and questionnaires. The questionnaires were used to assess the effectiveness of the manual.

The 3 questions on the prequestionnaire and 3 questions on the postquestionnaire were geared to measure the caregiver’s knowledge. There also were 4 questions on the postquestionnaire that were used to address manual revisions.

On the prequestionnaire form, the following questions were asked: (1) If you needed to find caregiver support resources, how much knowledge do you have finding the resources that fit your needs as well as the veteran’s needs? (2) Rate how aware you are with knowing what caregiver support resources are available at the VA and within the community; and (3) Would knowing which caregiver support resources to choose from at the VA and within the community decrease your stress level and give you “peace of mind?”

The same questions were asked postintervention, and the participants were asked to rate their knowledge after reviewing the manual. The participant’s responses on the questionnaires were measured using a 5-point Likert scale.

Participant Demographics

Demographic information was obtained from the cover letter distributed to each participant. The demographic information included age, gender, relationship to the veteran, and number of years to date in the current caregiving role. Participants eligible for inclusion in this project were primary caregivers of veterans with disabilities from all eras of conflict, aged ≥ 18 years.

Fifteen caregivers participated by returning the cover letter containing the implied consent, reading the manual, and completing the pre- and postquestionnaires. There was a wide age range of caregivers who participated, from 29 to 77 years. Of those who responded, there also was a wide range in time in their current caregiving role, ranging from 1 to 41 years. The mean number of years in the current caregiving role was 7 years.

Of the 15 participants, most were female spouses. There were no husbands who participated. The relative’s category included a cousin, a son, and a daughter. The “other” category included a son-in-law and a fiancé.

Data Analysis

Both outcomes were measured using the responses from questions 1 through 3 with the use of running a descriptive statistical analysis. In addition, a t test was used to determine statistical significance, set at α level < .05 of knowledge increase from pre- to postintervention data. Based on the facility, educational benchmarks were set at 80% with the 80% equal to 4 on the Likert scale. Therefore, 80% was the identified benchmark for this project. The goal was that > 70% of the participants would score 80% or better on the postquestionnaire.

Results

Both outcomes were met: (1) increasing the caregiver’s knowledge regarding resources available at the VA and within the community to decrease caregiver burden; and (2) assisting the caregiver in deciding which caregiver resources located in the manual were the right fit for the caregiver and the veteran for whom they were caring. The percentage of participants who scored 80% or better on the prequestionnaire was 54% (n = 8). The postquestionnaire outcomes were considered an improvement based on caregiver’s knowledge of support resources as well as whether the information in the manual decreased their stress level and gave them peace of mind. The intended outcome for the postquestionnaire was that > 70% of the participants would score ≥ 80% after the intervention. This goal was met as final results revealed 73% (n = 11) of the participants scored > 80% on the postquestionnaire.

The postresults supported that caregivers’ knowledge increased, they had peace of mind, and stress levels were decreased with the use of an educational intervention, a comprehensive Caregiver Resource Manual. The postquestionnaire revealed that all of the participants found the Caregiver Resource Manual easy to navigate, and 93% of participants found the Caregiver Resource Manual useful. Out of 15 participants, 8 provided comments. Seven provided positive comments, reporting that the information in the manual was interesting, the manual was simple/easy to read, and the outside resources listed were helpful.

The participant who provided a negative comment was one of the caregivers who did not meet the benchmark of 80% on the pre- or postquestionnaire. The participant was a 33-year-old wife of a veteran with disabilities who had been in the current caregiving role for 9 years. This participant reported that the Caregiver Resource Manual was not geared to younger caregivers, so she would not benefit from using the manual. This caregiver also was the only participant who reported that the Caregiver Resource Manual neither gave her peace of mind nor decreased her stress level.

Comments or suggestions would have been helpful from the other 8 individuals. Because it was not written in the IRB proposal to contact the participants other than to follow-up with telephone calls regarding unreturned questionnaires, no further contact was made with the participants.

Discussion

The preliminary success of this project suggests that there is a significant need for an educational conduit to ensure sufficient caregiver knowledge. Interprofessional collaborative efforts along with using information systems/technology to deliver the Caregiver Resource Manual electronically are important future consideration for improvement of the overall outcomes for a wide range of caregivers, veterans, and health care providers. Health care policy changes on the organizational level, systems level, and national level could further support caregivers of disabled veterans by enabling easy access to caregiver resources as a mandated practice.

Limitations

Limitations centered on the recruitment process. There were a total of 15 caregivers who participated. Although the participation did not meet the PC’s expectation, the final number of participants was adequate in obtaining data regarding evaluating the impact of this project.

Conclusion

The results of this project provided evidence that the Caregiver Resource Manual was effective. Caregivers gained a sense of knowledge and empowerment regarding available resources within the VA and the community. Providing the caregiver with peace of mind and improving the overall health and well-being of the caregiver and veteran were essential.

Moreover, just as the veterans who fought for freedom were equipped with full body armor to help protect them from the potential negative consequences of combat, caregivers who care for these brave soldiers are now equipped with a resource tool and a “full armor of knowledge” to care for their loved ones…our nation’s heroes…our veterans.

Hyperhidrosis (HH) is sweating beyond that which is required for thermoregulation.¹ Secondary HH, which is usually caused by an underlying medical condition or drug, may be seen in patients with spinal cord injury (SCI) and can negatively impact psychosocial well-being and quality of life (QOL) if not treated.¹

Information on the current prevalence of HH is lacking. In 2004, one study projected the prevalence of HH in the U.S. to be 2.8%.² A previous study found that about 27% of the 154 patients with SCI reported experiencing HH that was annoying, with 28 (14.6%) of those reporting no contributing somatic causes.³ Somatic causes of HH include autonomic dysreflexia, posttraumatic syringomyelia, or orthostatic hypotension.⁴

Autonomic dysreflexia is a syndrome that describes a dramatic increase in blood pressure (BP) in patients with spinal cord lesion at or above T6 and is characterized by exaggerated autonomic responses to stimuli that are innocuous to individuals without SCI.^5,6 Noxious stimuli that may trigger autonomic dysreflexia include bowel or bladder distension or obstruction, urinary infection, catheter insertion, suprapubic palpation, or skin irritation.⁶ Syringomyelia, another somatic cause of HH, is a cystic lesion on the spinal cord that may develop secondary to congenital anomalies or SCI.^6-8

The following case reports describe 2 patients with SCI with different diagnoses and presentations of HH. Both were treated with oxybutynin for HH.

Case 1 Presentation

Mr. J is a 49-year-old with C6-C7 SCI attributed to a motor vehicle accident 26 years before. He presented to the primary care clinic for a routine visit in a self-propelled wheelchair. His diagnosis included tetraplegia, muscle spasms, osteoporosis, chronic pain syndrome, benign prosthetic hypertrophy, neurogenic bladder, and neurogenic bowel. He was noted to have a bath towel around his neck to wipe sweat from his face and neck. He did not recall when this condition started; however, he reported a prior trial of diazepam 5 mg as needed in 2006 in the mornings and before transfers when sweating was usually worst. He continued to use diazepam because it helped with his muscle spasms but not with sweating. His other medications included oral baclofen, alendronate, ibuprofen, docusate sodium, tamsulosin, calcium/vitamin C supplement, and bisacodyl suppository.

The patient’s surgical history was significant for anterior discectomy with C6-C7 fusion, sphincterotomy, transurethral resection of the prostate, and right urethral stent placement for hydronephrosis in 2004. His cystoscopy and renal sonogram were within normal limits. On physical examination, his vital signs were within normal limits. However, his long-sleeved shirt was wet on the front, and his neck, chest, and arms also were moist from excessive sweating. During his transfer to and from his wheelchair, he was noted to have chattering of his teeth. The remainder of the physical examination was negative for any other acute findings.

Mr. J was prescribed a 30-day trial of oxybutynin 5 mg 1 tablet by mouth per day for HH. During a 3-week follow-up telephone call, Mr. J reported that the oxybutynin was working well; the sweating on his chest had improved and had resolved on his face. Except for mild dryness of mouth, he was tolerating the medication well. There were no changes in his neurogenic bladder, which was managed with an external urinary device.

Six months later, Mr. J reported that oxybutynin continued to work well, and he no longer had to travel with a towel. He was able to go to a football game, social activities were more enjoyable, and he was not embarrassed because of excessive sweating.

Case 2 Presentation

Mr. B is a 48-year-old with T12 paraplegia secondary to a motor vehicle accident in 1994. He called the primary clinic for a visit because he was concerned about cold clammy hands for the past 6 to 7 months when he woke up in the morning and sometimes throughout the day. He was preparing to start his first semester in college. His diagnosis included neurogenic bowel and bladder and muscle spasms. There was no history of posttraumatic syringomyelia, and his medications included baclofen, dantrolene, diazepam, and multivitamins.

Mr. B took tolterodine 4 mg/d for several years, and for unknown reasons, about 6 years previously the prescription was changed to oxybutynin 15-mg extended release for his neurogenic bladder. He continued to have urinary leakage between the every 4-hour intermittent catherization, and oxybutynin was increased to 10-mg tablet twice per day.

About 7 months prior to this appointment, Mr. B independently stopped the oxybutynin as he felt that it was not making a difference in the management of his neurogenic bladder. It was noted that his cold clammy hands started about the same time that he discontinued the oxybutynin. He could not recall whether he had this symptom prior to initiation of any medication. It was mutually decided to restart the oxybutynin at a lower dose, this time not for his bladder but for the HH. He was ordered a 30-day trial of a 5-mg tablet once per day. About 3 weeks later, he sent a secure message to report oxybutynin’s effectiveness and to request a refill.

Discussion

Sweating is a physiological process that involves the active secretion of water by specialized sweat glands in the skin.^9-11 There are 2 types of sweat glands in the skin; apocrine and eccrine.⁹ Collectively the 3 million eccrine sweat glands of the average person approximately equal the mass of a kidney and exceed the secretory rate of exocrine glands.⁹ They function in evaporative cooling in response to thermal or physiologic stimuli and are widely distributed over the body, especially on the forehead, back, palms, and soles.¹⁰

Sympathetic cholinergic nerves are mainly responsible for sweat secretion by the release of acetylcholine to activate muscarinic receptors on the gland.¹¹ Postganglionic fibers from sympathetic nerve cells innervate sweat glands that release cholinergics.⁶ Postganglionic cholinergic receptors that are activated by muscarinic drugs are termed muscarinic receptors and are readily accessible to antimuscarinic drugs.^6,12 Anticholinergic/antimuscarinic agents antagonize muscarinic receptors and suppress premature detrusor contractions to enhance bladder storage.¹³ They include oxybutynin, tolterodine, trospium, solifenacin, darifenacin, and fesoterodine.¹³ Oxybutynin was used in both cases because it is on VA formulary. It was effective in treating HH, although the etiology is unclear and the presentations were different.

One retrospective study that analyzed 20 patients who received oxybutynin for primary HH at uncommon sites, such as the back and groin, found that QOL improved in 85% of the subjects after 6 weeks.¹⁴ Randomized placebo-controlled trials also have found oxybutynin effective for treatment of palmar and axillary HH and generalized HH.^15,16

Syringomyelia was ruled out in both cases based on history and radiologic studies, specifically magnetic resonance imaging. Autonomic dysreflexia was ruled out as the HH was not an acute finding and BP was within normal limits. Orthostatic hypotension is a common finding in SCI, mainly in tetraplegic patients, and could be suspected in both cases. Sweating was usually worse in the mornings in both cases and during transfers, as noted in the first case.¹⁷ However, chronic autoregulation allows for chronic adaption to tissue hypoperfusion over time.¹⁶

Hyperhidrosis or other disorders of eccrine sweating can occur for various reasons, including changes in the spinal sympathetic preganglionic, ganglionic, or postganglionic neurons; dysfunction of the thermoregulatory centers in the brain’s central autonomic network; or changes in the muscarinic cholinergic synapse on sweat glands.¹⁸

Conclusion

Patients with SCI may have an acute or chronic presentation of HH. Removal of the inciting cause in the case of autonomic dysreflexia and/or the administration of a pharmaceutical agent is the usual treatment.

Regardless of the etiology of HH that persists, effective treatment should be a goal, especially in those patients whose QOL is affected by this condition. The outcome of treatment with oxybutynin in these case reports is consistent with the findings of the limited retrospective study and randomized placebo-controlled studies that show oxybutynin is effective for treating bothersome HH.^14-16

The results of these case reports are not generalizable to patients with SCI and HH, nor are the results of the limited retrospective study and randomized placebo-controlled studies, as their sample sizes were small.^14,16,17 However, information on the use of oxybutynin for the effective treatment of HH in the SCI population is promising. Research studies on the prevalence of HH and randomized placebo-controlled trials with a larger SCI population are considerations for future studies.

Hyperhidrosis (HH) is sweating beyond that which is required for thermoregulation.¹ Secondary HH, which is usually caused by an underlying medical condition or drug, may be seen in patients with spinal cord injury (SCI) and can negatively impact psychosocial well-being and quality of life (QOL) if not treated.¹

Information on the current prevalence of HH is lacking. In 2004, one study projected the prevalence of HH in the U.S. to be 2.8%.² A previous study found that about 27% of the 154 patients with SCI reported experiencing HH that was annoying, with 28 (14.6%) of those reporting no contributing somatic causes.³ Somatic causes of HH include autonomic dysreflexia, posttraumatic syringomyelia, or orthostatic hypotension.⁴

Autonomic dysreflexia is a syndrome that describes a dramatic increase in blood pressure (BP) in patients with spinal cord lesion at or above T6 and is characterized by exaggerated autonomic responses to stimuli that are innocuous to individuals without SCI.^5,6 Noxious stimuli that may trigger autonomic dysreflexia include bowel or bladder distension or obstruction, urinary infection, catheter insertion, suprapubic palpation, or skin irritation.⁶ Syringomyelia, another somatic cause of HH, is a cystic lesion on the spinal cord that may develop secondary to congenital anomalies or SCI.^6-8

The following case reports describe 2 patients with SCI with different diagnoses and presentations of HH. Both were treated with oxybutynin for HH.

Case 1 Presentation

Mr. J is a 49-year-old with C6-C7 SCI attributed to a motor vehicle accident 26 years before. He presented to the primary care clinic for a routine visit in a self-propelled wheelchair. His diagnosis included tetraplegia, muscle spasms, osteoporosis, chronic pain syndrome, benign prosthetic hypertrophy, neurogenic bladder, and neurogenic bowel. He was noted to have a bath towel around his neck to wipe sweat from his face and neck. He did not recall when this condition started; however, he reported a prior trial of diazepam 5 mg as needed in 2006 in the mornings and before transfers when sweating was usually worst. He continued to use diazepam because it helped with his muscle spasms but not with sweating. His other medications included oral baclofen, alendronate, ibuprofen, docusate sodium, tamsulosin, calcium/vitamin C supplement, and bisacodyl suppository.

The patient’s surgical history was significant for anterior discectomy with C6-C7 fusion, sphincterotomy, transurethral resection of the prostate, and right urethral stent placement for hydronephrosis in 2004. His cystoscopy and renal sonogram were within normal limits. On physical examination, his vital signs were within normal limits. However, his long-sleeved shirt was wet on the front, and his neck, chest, and arms also were moist from excessive sweating. During his transfer to and from his wheelchair, he was noted to have chattering of his teeth. The remainder of the physical examination was negative for any other acute findings.

Mr. J was prescribed a 30-day trial of oxybutynin 5 mg 1 tablet by mouth per day for HH. During a 3-week follow-up telephone call, Mr. J reported that the oxybutynin was working well; the sweating on his chest had improved and had resolved on his face. Except for mild dryness of mouth, he was tolerating the medication well. There were no changes in his neurogenic bladder, which was managed with an external urinary device.

Six months later, Mr. J reported that oxybutynin continued to work well, and he no longer had to travel with a towel. He was able to go to a football game, social activities were more enjoyable, and he was not embarrassed because of excessive sweating.

Case 2 Presentation

Mr. B is a 48-year-old with T12 paraplegia secondary to a motor vehicle accident in 1994. He called the primary clinic for a visit because he was concerned about cold clammy hands for the past 6 to 7 months when he woke up in the morning and sometimes throughout the day. He was preparing to start his first semester in college. His diagnosis included neurogenic bowel and bladder and muscle spasms. There was no history of posttraumatic syringomyelia, and his medications included baclofen, dantrolene, diazepam, and multivitamins.

Mr. B took tolterodine 4 mg/d for several years, and for unknown reasons, about 6 years previously the prescription was changed to oxybutynin 15-mg extended release for his neurogenic bladder. He continued to have urinary leakage between the every 4-hour intermittent catherization, and oxybutynin was increased to 10-mg tablet twice per day.

About 7 months prior to this appointment, Mr. B independently stopped the oxybutynin as he felt that it was not making a difference in the management of his neurogenic bladder. It was noted that his cold clammy hands started about the same time that he discontinued the oxybutynin. He could not recall whether he had this symptom prior to initiation of any medication. It was mutually decided to restart the oxybutynin at a lower dose, this time not for his bladder but for the HH. He was ordered a 30-day trial of a 5-mg tablet once per day. About 3 weeks later, he sent a secure message to report oxybutynin’s effectiveness and to request a refill.

Discussion

Sweating is a physiological process that involves the active secretion of water by specialized sweat glands in the skin.^9-11 There are 2 types of sweat glands in the skin; apocrine and eccrine.⁹ Collectively the 3 million eccrine sweat glands of the average person approximately equal the mass of a kidney and exceed the secretory rate of exocrine glands.⁹ They function in evaporative cooling in response to thermal or physiologic stimuli and are widely distributed over the body, especially on the forehead, back, palms, and soles.¹⁰

Sympathetic cholinergic nerves are mainly responsible for sweat secretion by the release of acetylcholine to activate muscarinic receptors on the gland.¹¹ Postganglionic fibers from sympathetic nerve cells innervate sweat glands that release cholinergics.⁶ Postganglionic cholinergic receptors that are activated by muscarinic drugs are termed muscarinic receptors and are readily accessible to antimuscarinic drugs.^6,12 Anticholinergic/antimuscarinic agents antagonize muscarinic receptors and suppress premature detrusor contractions to enhance bladder storage.¹³ They include oxybutynin, tolterodine, trospium, solifenacin, darifenacin, and fesoterodine.¹³ Oxybutynin was used in both cases because it is on VA formulary. It was effective in treating HH, although the etiology is unclear and the presentations were different.

One retrospective study that analyzed 20 patients who received oxybutynin for primary HH at uncommon sites, such as the back and groin, found that QOL improved in 85% of the subjects after 6 weeks.¹⁴ Randomized placebo-controlled trials also have found oxybutynin effective for treatment of palmar and axillary HH and generalized HH.^15,16

Syringomyelia was ruled out in both cases based on history and radiologic studies, specifically magnetic resonance imaging. Autonomic dysreflexia was ruled out as the HH was not an acute finding and BP was within normal limits. Orthostatic hypotension is a common finding in SCI, mainly in tetraplegic patients, and could be suspected in both cases. Sweating was usually worse in the mornings in both cases and during transfers, as noted in the first case.¹⁷ However, chronic autoregulation allows for chronic adaption to tissue hypoperfusion over time.¹⁶

Hyperhidrosis or other disorders of eccrine sweating can occur for various reasons, including changes in the spinal sympathetic preganglionic, ganglionic, or postganglionic neurons; dysfunction of the thermoregulatory centers in the brain’s central autonomic network; or changes in the muscarinic cholinergic synapse on sweat glands.¹⁸

Conclusion

Patients with SCI may have an acute or chronic presentation of HH. Removal of the inciting cause in the case of autonomic dysreflexia and/or the administration of a pharmaceutical agent is the usual treatment.

Regardless of the etiology of HH that persists, effective treatment should be a goal, especially in those patients whose QOL is affected by this condition. The outcome of treatment with oxybutynin in these case reports is consistent with the findings of the limited retrospective study and randomized placebo-controlled studies that show oxybutynin is effective for treating bothersome HH.^14-16

The results of these case reports are not generalizable to patients with SCI and HH, nor are the results of the limited retrospective study and randomized placebo-controlled studies, as their sample sizes were small.^14,16,17 However, information on the use of oxybutynin for the effective treatment of HH in the SCI population is promising. Research studies on the prevalence of HH and randomized placebo-controlled trials with a larger SCI population are considerations for future studies.

Hyperhidrosis (HH) is sweating beyond that which is required for thermoregulation.¹ Secondary HH, which is usually caused by an underlying medical condition or drug, may be seen in patients with spinal cord injury (SCI) and can negatively impact psychosocial well-being and quality of life (QOL) if not treated.¹

Information on the current prevalence of HH is lacking. In 2004, one study projected the prevalence of HH in the U.S. to be 2.8%.² A previous study found that about 27% of the 154 patients with SCI reported experiencing HH that was annoying, with 28 (14.6%) of those reporting no contributing somatic causes.³ Somatic causes of HH include autonomic dysreflexia, posttraumatic syringomyelia, or orthostatic hypotension.⁴

Autonomic dysreflexia is a syndrome that describes a dramatic increase in blood pressure (BP) in patients with spinal cord lesion at or above T6 and is characterized by exaggerated autonomic responses to stimuli that are innocuous to individuals without SCI.^5,6 Noxious stimuli that may trigger autonomic dysreflexia include bowel or bladder distension or obstruction, urinary infection, catheter insertion, suprapubic palpation, or skin irritation.⁶ Syringomyelia, another somatic cause of HH, is a cystic lesion on the spinal cord that may develop secondary to congenital anomalies or SCI.^6-8

The following case reports describe 2 patients with SCI with different diagnoses and presentations of HH. Both were treated with oxybutynin for HH.

Case 1 Presentation

Mr. J is a 49-year-old with C6-C7 SCI attributed to a motor vehicle accident 26 years before. He presented to the primary care clinic for a routine visit in a self-propelled wheelchair. His diagnosis included tetraplegia, muscle spasms, osteoporosis, chronic pain syndrome, benign prosthetic hypertrophy, neurogenic bladder, and neurogenic bowel. He was noted to have a bath towel around his neck to wipe sweat from his face and neck. He did not recall when this condition started; however, he reported a prior trial of diazepam 5 mg as needed in 2006 in the mornings and before transfers when sweating was usually worst. He continued to use diazepam because it helped with his muscle spasms but not with sweating. His other medications included oral baclofen, alendronate, ibuprofen, docusate sodium, tamsulosin, calcium/vitamin C supplement, and bisacodyl suppository.

The patient’s surgical history was significant for anterior discectomy with C6-C7 fusion, sphincterotomy, transurethral resection of the prostate, and right urethral stent placement for hydronephrosis in 2004. His cystoscopy and renal sonogram were within normal limits. On physical examination, his vital signs were within normal limits. However, his long-sleeved shirt was wet on the front, and his neck, chest, and arms also were moist from excessive sweating. During his transfer to and from his wheelchair, he was noted to have chattering of his teeth. The remainder of the physical examination was negative for any other acute findings.

Mr. J was prescribed a 30-day trial of oxybutynin 5 mg 1 tablet by mouth per day for HH. During a 3-week follow-up telephone call, Mr. J reported that the oxybutynin was working well; the sweating on his chest had improved and had resolved on his face. Except for mild dryness of mouth, he was tolerating the medication well. There were no changes in his neurogenic bladder, which was managed with an external urinary device.

Six months later, Mr. J reported that oxybutynin continued to work well, and he no longer had to travel with a towel. He was able to go to a football game, social activities were more enjoyable, and he was not embarrassed because of excessive sweating.

Case 2 Presentation

Mr. B is a 48-year-old with T12 paraplegia secondary to a motor vehicle accident in 1994. He called the primary clinic for a visit because he was concerned about cold clammy hands for the past 6 to 7 months when he woke up in the morning and sometimes throughout the day. He was preparing to start his first semester in college. His diagnosis included neurogenic bowel and bladder and muscle spasms. There was no history of posttraumatic syringomyelia, and his medications included baclofen, dantrolene, diazepam, and multivitamins.

Mr. B took tolterodine 4 mg/d for several years, and for unknown reasons, about 6 years previously the prescription was changed to oxybutynin 15-mg extended release for his neurogenic bladder. He continued to have urinary leakage between the every 4-hour intermittent catherization, and oxybutynin was increased to 10-mg tablet twice per day.

About 7 months prior to this appointment, Mr. B independently stopped the oxybutynin as he felt that it was not making a difference in the management of his neurogenic bladder. It was noted that his cold clammy hands started about the same time that he discontinued the oxybutynin. He could not recall whether he had this symptom prior to initiation of any medication. It was mutually decided to restart the oxybutynin at a lower dose, this time not for his bladder but for the HH. He was ordered a 30-day trial of a 5-mg tablet once per day. About 3 weeks later, he sent a secure message to report oxybutynin’s effectiveness and to request a refill.

Discussion

Sweating is a physiological process that involves the active secretion of water by specialized sweat glands in the skin.^9-11 There are 2 types of sweat glands in the skin; apocrine and eccrine.⁹ Collectively the 3 million eccrine sweat glands of the average person approximately equal the mass of a kidney and exceed the secretory rate of exocrine glands.⁹ They function in evaporative cooling in response to thermal or physiologic stimuli and are widely distributed over the body, especially on the forehead, back, palms, and soles.¹⁰

Sympathetic cholinergic nerves are mainly responsible for sweat secretion by the release of acetylcholine to activate muscarinic receptors on the gland.¹¹ Postganglionic fibers from sympathetic nerve cells innervate sweat glands that release cholinergics.⁶ Postganglionic cholinergic receptors that are activated by muscarinic drugs are termed muscarinic receptors and are readily accessible to antimuscarinic drugs.^6,12 Anticholinergic/antimuscarinic agents antagonize muscarinic receptors and suppress premature detrusor contractions to enhance bladder storage.¹³ They include oxybutynin, tolterodine, trospium, solifenacin, darifenacin, and fesoterodine.¹³ Oxybutynin was used in both cases because it is on VA formulary. It was effective in treating HH, although the etiology is unclear and the presentations were different.

One retrospective study that analyzed 20 patients who received oxybutynin for primary HH at uncommon sites, such as the back and groin, found that QOL improved in 85% of the subjects after 6 weeks.¹⁴ Randomized placebo-controlled trials also have found oxybutynin effective for treatment of palmar and axillary HH and generalized HH.^15,16

Syringomyelia was ruled out in both cases based on history and radiologic studies, specifically magnetic resonance imaging. Autonomic dysreflexia was ruled out as the HH was not an acute finding and BP was within normal limits. Orthostatic hypotension is a common finding in SCI, mainly in tetraplegic patients, and could be suspected in both cases. Sweating was usually worse in the mornings in both cases and during transfers, as noted in the first case.¹⁷ However, chronic autoregulation allows for chronic adaption to tissue hypoperfusion over time.¹⁶

Hyperhidrosis or other disorders of eccrine sweating can occur for various reasons, including changes in the spinal sympathetic preganglionic, ganglionic, or postganglionic neurons; dysfunction of the thermoregulatory centers in the brain’s central autonomic network; or changes in the muscarinic cholinergic synapse on sweat glands.¹⁸

Conclusion

Patients with SCI may have an acute or chronic presentation of HH. Removal of the inciting cause in the case of autonomic dysreflexia and/or the administration of a pharmaceutical agent is the usual treatment.

Regardless of the etiology of HH that persists, effective treatment should be a goal, especially in those patients whose QOL is affected by this condition. The outcome of treatment with oxybutynin in these case reports is consistent with the findings of the limited retrospective study and randomized placebo-controlled studies that show oxybutynin is effective for treating bothersome HH.^14-16

The results of these case reports are not generalizable to patients with SCI and HH, nor are the results of the limited retrospective study and randomized placebo-controlled studies, as their sample sizes were small.^14,16,17 However, information on the use of oxybutynin for the effective treatment of HH in the SCI population is promising. Research studies on the prevalence of HH and randomized placebo-controlled trials with a larger SCI population are considerations for future studies.

Photo by Patrick Pelletier

Long-term follow-up of patients treated with imatinib suggests the drug can remain effective beyond 10 years and does not confer “unacceptable” cumulative toxicity, according to researchers.

The group evaluated data on patients who had newly diagnosed, chronic-phase chronic myeloid leukemia (CML) when they began treatment with imatinib.

The median treatment duration was 8.9 years, and the estimated 10-year survival rate ranged from 64.4% to 84.4%.

The researchers said serious adverse events (AEs) thought to be related to imatinib were uncommon and typically occurred early, within the first year of treatment.

These results were reported in NEJM. The research was funded by Novartis Pharmaceuticals, which markets imatinib as Gleevec.

“The long-term success of this treatment confirms the remarkable success we’ve seen since the very first Gleevec trials,” said study author Brian Druker, MD, a physician-scientist at Oregon Health & Science University in Portland, Oregon, who led the original clinical development of Gleevec.

“This study reinforces the notion that we can create effective and non-toxic therapies.”

The study enrolled 1106 newly diagnosed, chronic-phase CML patients at 177 cancer centers in more than 16 countries. Half were assigned to treatment with imatinib (n=533) and the other half to interferon alfa plus cytarabine.

This study allowed for cross-over between the treatment arms, and 65.6% of patients in the cytarabine/interferon alfa arm ultimately crossed over to the imatinib arm.

However, when assessing the effects of imatinib, the researchers focused only on the patients who were first randomized to receive imatinib.

The median follow-up was 10.9 years (range, 0 to 11.7, which included follow-up after patients discontinued study treatment).

Of the patients randomized to imatinib, 48.3% (n=267) completed treatment with the drug. The median duration of first-line imatinib was 8.9 years (range, <0.1 to 11.7).

For patients who did not complete imatinib treatment, reasons for discontinuation included a lack of efficacy (15.9%), withdrawn consent (10.3%), AEs (6.9%), because they proceeded to transplant (3.8%), death (3.4%), protocol violation (3.1%), loss to follow-up (2.7%), cross over to the interferon arm (2.5%), administrative problems (2.2%), abnormal laboratory values (0.5%), or abnormal procedure (0.4%).

Safety

The incidence of serious AEs considered related to imatinib was 9.3% (51/551).

Drug-related serious AEs occurring in at least 2 patients included abdominal pain (n=4), anemia (n=3), congestive cardiac failure (n=3), gastrointestinal hemorrhage (n=3), vomiting (n=3), alanine aminotransferase increase (n=2), cardiac arrest (n=2), conjunctival hemorrhage (n=2), and melana (n=2).

Six patients had a second neoplasm (benign, malignant, or unspecified).

Response

The cumulative rate of complete cytogenetic response (CCR) at the end of the trial was 82.8%.

In the intent-to-treat population, the rate of CCR went from 52.8% in the first year to 22.2% at year 10.

Among evaluable patients, the rate of CCR went from 70.9% (292/412) in the first year to 91.8% (123/134) in year 10.

In the intent-to-treat population, the rate of major molecular response went from 27.7% in the first year to 34.4% at year 10.

Among evaluable patients, the rate of major molecular response went from 50.2% (153/305) in the first year to 93.1% (190/204) in year 10.

Progression and survival

The rate of progression was 6.9% (38/553) in the intent-to-treat population. Most of these patients (n=34) progressed during the first 4 years.

There were 260 patients who were still alive and receiving imatinib at 10 years and 96 patients who were alive but not receiving imatinib.

The researchers did not know the survival status of 111 patients, and there were 86 known deaths at 10 years (89 by the end of the study).

The estimated 10-year survival rate ranged from 64.4% (assuming all 111 patients with unknown status had died) to 84.4% (assuming all 111 were alive).

The cause of death was CML in 50 patients, a secondary malignant condition in 11, a cardiac disorder/cardiovascular disease in 7, infectious disease in 5, and “other” causes in 16 patients.

Photo by Patrick Pelletier

Long-term follow-up of patients treated with imatinib suggests the drug can remain effective beyond 10 years and does not confer “unacceptable” cumulative toxicity, according to researchers.

The group evaluated data on patients who had newly diagnosed, chronic-phase chronic myeloid leukemia (CML) when they began treatment with imatinib.

The median treatment duration was 8.9 years, and the estimated 10-year survival rate ranged from 64.4% to 84.4%.

The researchers said serious adverse events (AEs) thought to be related to imatinib were uncommon and typically occurred early, within the first year of treatment.

These results were reported in NEJM. The research was funded by Novartis Pharmaceuticals, which markets imatinib as Gleevec.

“The long-term success of this treatment confirms the remarkable success we’ve seen since the very first Gleevec trials,” said study author Brian Druker, MD, a physician-scientist at Oregon Health & Science University in Portland, Oregon, who led the original clinical development of Gleevec.

“This study reinforces the notion that we can create effective and non-toxic therapies.”

The study enrolled 1106 newly diagnosed, chronic-phase CML patients at 177 cancer centers in more than 16 countries. Half were assigned to treatment with imatinib (n=533) and the other half to interferon alfa plus cytarabine.

This study allowed for cross-over between the treatment arms, and 65.6% of patients in the cytarabine/interferon alfa arm ultimately crossed over to the imatinib arm.

However, when assessing the effects of imatinib, the researchers focused only on the patients who were first randomized to receive imatinib.

The median follow-up was 10.9 years (range, 0 to 11.7, which included follow-up after patients discontinued study treatment).

Of the patients randomized to imatinib, 48.3% (n=267) completed treatment with the drug. The median duration of first-line imatinib was 8.9 years (range, <0.1 to 11.7).

For patients who did not complete imatinib treatment, reasons for discontinuation included a lack of efficacy (15.9%), withdrawn consent (10.3%), AEs (6.9%), because they proceeded to transplant (3.8%), death (3.4%), protocol violation (3.1%), loss to follow-up (2.7%), cross over to the interferon arm (2.5%), administrative problems (2.2%), abnormal laboratory values (0.5%), or abnormal procedure (0.4%).

Safety

The incidence of serious AEs considered related to imatinib was 9.3% (51/551).

Drug-related serious AEs occurring in at least 2 patients included abdominal pain (n=4), anemia (n=3), congestive cardiac failure (n=3), gastrointestinal hemorrhage (n=3), vomiting (n=3), alanine aminotransferase increase (n=2), cardiac arrest (n=2), conjunctival hemorrhage (n=2), and melana (n=2).

Six patients had a second neoplasm (benign, malignant, or unspecified).

Response

The cumulative rate of complete cytogenetic response (CCR) at the end of the trial was 82.8%.

In the intent-to-treat population, the rate of CCR went from 52.8% in the first year to 22.2% at year 10.

Among evaluable patients, the rate of CCR went from 70.9% (292/412) in the first year to 91.8% (123/134) in year 10.

In the intent-to-treat population, the rate of major molecular response went from 27.7% in the first year to 34.4% at year 10.

Among evaluable patients, the rate of major molecular response went from 50.2% (153/305) in the first year to 93.1% (190/204) in year 10.

Progression and survival

The rate of progression was 6.9% (38/553) in the intent-to-treat population. Most of these patients (n=34) progressed during the first 4 years.

There were 260 patients who were still alive and receiving imatinib at 10 years and 96 patients who were alive but not receiving imatinib.

The researchers did not know the survival status of 111 patients, and there were 86 known deaths at 10 years (89 by the end of the study).

The estimated 10-year survival rate ranged from 64.4% (assuming all 111 patients with unknown status had died) to 84.4% (assuming all 111 were alive).

The cause of death was CML in 50 patients, a secondary malignant condition in 11, a cardiac disorder/cardiovascular disease in 7, infectious disease in 5, and “other” causes in 16 patients.

Photo by Patrick Pelletier

Long-term follow-up of patients treated with imatinib suggests the drug can remain effective beyond 10 years and does not confer “unacceptable” cumulative toxicity, according to researchers.

The group evaluated data on patients who had newly diagnosed, chronic-phase chronic myeloid leukemia (CML) when they began treatment with imatinib.

The median treatment duration was 8.9 years, and the estimated 10-year survival rate ranged from 64.4% to 84.4%.

The researchers said serious adverse events (AEs) thought to be related to imatinib were uncommon and typically occurred early, within the first year of treatment.

These results were reported in NEJM. The research was funded by Novartis Pharmaceuticals, which markets imatinib as Gleevec.

“The long-term success of this treatment confirms the remarkable success we’ve seen since the very first Gleevec trials,” said study author Brian Druker, MD, a physician-scientist at Oregon Health & Science University in Portland, Oregon, who led the original clinical development of Gleevec.

“This study reinforces the notion that we can create effective and non-toxic therapies.”

The study enrolled 1106 newly diagnosed, chronic-phase CML patients at 177 cancer centers in more than 16 countries. Half were assigned to treatment with imatinib (n=533) and the other half to interferon alfa plus cytarabine.

This study allowed for cross-over between the treatment arms, and 65.6% of patients in the cytarabine/interferon alfa arm ultimately crossed over to the imatinib arm.

However, when assessing the effects of imatinib, the researchers focused only on the patients who were first randomized to receive imatinib.

The median follow-up was 10.9 years (range, 0 to 11.7, which included follow-up after patients discontinued study treatment).

Of the patients randomized to imatinib, 48.3% (n=267) completed treatment with the drug. The median duration of first-line imatinib was 8.9 years (range, <0.1 to 11.7).

For patients who did not complete imatinib treatment, reasons for discontinuation included a lack of efficacy (15.9%), withdrawn consent (10.3%), AEs (6.9%), because they proceeded to transplant (3.8%), death (3.4%), protocol violation (3.1%), loss to follow-up (2.7%), cross over to the interferon arm (2.5%), administrative problems (2.2%), abnormal laboratory values (0.5%), or abnormal procedure (0.4%).

Safety

The incidence of serious AEs considered related to imatinib was 9.3% (51/551).

Drug-related serious AEs occurring in at least 2 patients included abdominal pain (n=4), anemia (n=3), congestive cardiac failure (n=3), gastrointestinal hemorrhage (n=3), vomiting (n=3), alanine aminotransferase increase (n=2), cardiac arrest (n=2), conjunctival hemorrhage (n=2), and melana (n=2).

Six patients had a second neoplasm (benign, malignant, or unspecified).

Response

The cumulative rate of complete cytogenetic response (CCR) at the end of the trial was 82.8%.

In the intent-to-treat population, the rate of CCR went from 52.8% in the first year to 22.2% at year 10.

Among evaluable patients, the rate of CCR went from 70.9% (292/412) in the first year to 91.8% (123/134) in year 10.

In the intent-to-treat population, the rate of major molecular response went from 27.7% in the first year to 34.4% at year 10.

Among evaluable patients, the rate of major molecular response went from 50.2% (153/305) in the first year to 93.1% (190/204) in year 10.

Progression and survival

The rate of progression was 6.9% (38/553) in the intent-to-treat population. Most of these patients (n=34) progressed during the first 4 years.

There were 260 patients who were still alive and receiving imatinib at 10 years and 96 patients who were alive but not receiving imatinib.

The researchers did not know the survival status of 111 patients, and there were 86 known deaths at 10 years (89 by the end of the study).

The estimated 10-year survival rate ranged from 64.4% (assuming all 111 patients with unknown status had died) to 84.4% (assuming all 111 were alive).

The cause of death was CML in 50 patients, a secondary malignant condition in 11, a cardiac disorder/cardiovascular disease in 7, infectious disease in 5, and “other” causes in 16 patients.

Lab mouse

An experimental drug called LCL161 stimulates the immune system to fight multiple myeloma (MM), according to research published in Nature Medicine.

Investigators said LCL161 exhibited “robust” activity in a transgenic myeloma mouse model and in patients with relapsed/refractory MM.

Single-agent LCL161 did not produce responses in MM patients, but patients did respond to treatment with LCL161 and cyclophosphamide.

The investigators also found that single-agent LCL161 provided “long-term anti-tumor protection” in mice, and combining LCL161 with an antibody against PD-1 could cure mice of MM.

“The drug, LCL161, was initially developed to promote tumor death,” said study author Marta Chesi, PhD, of Mayo Clinic Arizona in Scottsdale.

“However, we found that the drug does not kill tumor cells directly. Rather, it makes them more visible to the immune system that recognizes them as foreign invaders and eliminates them.”

Dr Chesi and her colleagues explained that the cellular inhibitors of apoptosis (cIAP) 1 and 2 have been identified as potential therapeutic targets in some cancers.

And LCL161 is a small-molecule IAP antagonist that induces tumor necrosis factor-mediated apoptosis in cancer cells. However, the investigators found that LCL161 was not directly cytotoxic to MM cells.

Instead, the drug upregulated tumor-cell-autonomous type I interferon signaling and induced an acute inflammatory response. This led to the activation of macrophages and dendritic cells, which prompted phagocytosis in MM cells.

Results in mice

The investigators first tested LCL161 alone (at a dose previously shown to be well-tolerated) in Vk*MYC transgenic mice with established MM.

The team said they observed a reduction in tumor burden that was comparable to that observed in response to drugs currently used to treat MM—carfilzomib, bortezomib, melphalan, cyclophosphamide, panobinostat, dexamethasone, and pomalidomide.

The investigators then tested the combination of LCL161 and a PD1 antibody in Vk12598-tumor-bearing mice.

The team said the combination was curative in all mice that completed 2 weeks of treatment. In fact, it was more effective than combination treatment with LCL161 and cyclophosphamide.

Results in patients

Dr Chesi and her colleagues conducted a phase 2 trial of LCL161 in 25 patients with relapsed/refractory MM. Patients could receive cyclophosphamide if they failed to respond or progressed after 8 weeks of treatment with LCL161 alone.

The patients’ median age was 68 (range, 47-90), and they had a median of 3 prior therapies (range, 1-6). Forty-four percent of patients had high-risk features, 28% had relapsed disease, and 72% had relapsed and refractory disease.

Four patients experienced grade 2 cytokine release syndrome when they received LCL161 at a dose of 1800 mg weekly, so the dose was lowered to 1200 mg.

None of the patients responded to single-agent LCL161. So 23 of the patients received 500 mg of weekly cyclophosphamide as well.

There was 1 complete response to the combination therapy, 1 very good partial response, 2 partial responses, and 1 minimal response. The median progression-free survival in these patients was 10 months.

Grade 3 adverse events included decrease in neutrophil count (28%), decrease in lymphocyte count (28%), anemia (24%), fatigue (16%), hyperglycemia (12%), syncope (12%), decrease in white blood cell count (12%), decrease in platelet count (8%), increase in lymphocyte count (8%), nausea (4%), vomiting (4%), diarrhea (4%), maculo-papular rash (4%), hypotension (4%), lung infection (4%), pain in extremity (4%), and urticaria (4%).

Grade 4 events included decrease in lymphocyte count (24%), decrease in neutrophil count (8%), decrease in white blood cell count (8%), hyperuricemia (4%), decrease in platelet count (4%), and sepsis (4%).

Based on these results, the investigators said the combination of LCL161 and cyclophosphamide is “an attractive platform for future trials,” and the same is true for LCL161 in combination with anti-PD1 therapy.

The phase 2 trial was sponsored by Mayo Clinic and the National Cancer Institute. Novartis provided LCL161 for this research and supported the trial. 

Lab mouse

An experimental drug called LCL161 stimulates the immune system to fight multiple myeloma (MM), according to research published in Nature Medicine.

Investigators said LCL161 exhibited “robust” activity in a transgenic myeloma mouse model and in patients with relapsed/refractory MM.

Single-agent LCL161 did not produce responses in MM patients, but patients did respond to treatment with LCL161 and cyclophosphamide.

The investigators also found that single-agent LCL161 provided “long-term anti-tumor protection” in mice, and combining LCL161 with an antibody against PD-1 could cure mice of MM.

“The drug, LCL161, was initially developed to promote tumor death,” said study author Marta Chesi, PhD, of Mayo Clinic Arizona in Scottsdale.

“However, we found that the drug does not kill tumor cells directly. Rather, it makes them more visible to the immune system that recognizes them as foreign invaders and eliminates them.”

Dr Chesi and her colleagues explained that the cellular inhibitors of apoptosis (cIAP) 1 and 2 have been identified as potential therapeutic targets in some cancers.

And LCL161 is a small-molecule IAP antagonist that induces tumor necrosis factor-mediated apoptosis in cancer cells. However, the investigators found that LCL161 was not directly cytotoxic to MM cells.

Instead, the drug upregulated tumor-cell-autonomous type I interferon signaling and induced an acute inflammatory response. This led to the activation of macrophages and dendritic cells, which prompted phagocytosis in MM cells.

Results in mice

The investigators first tested LCL161 alone (at a dose previously shown to be well-tolerated) in Vk*MYC transgenic mice with established MM.

The team said they observed a reduction in tumor burden that was comparable to that observed in response to drugs currently used to treat MM—carfilzomib, bortezomib, melphalan, cyclophosphamide, panobinostat, dexamethasone, and pomalidomide.

The investigators then tested the combination of LCL161 and a PD1 antibody in Vk12598-tumor-bearing mice.

The team said the combination was curative in all mice that completed 2 weeks of treatment. In fact, it was more effective than combination treatment with LCL161 and cyclophosphamide.

Results in patients

Dr Chesi and her colleagues conducted a phase 2 trial of LCL161 in 25 patients with relapsed/refractory MM. Patients could receive cyclophosphamide if they failed to respond or progressed after 8 weeks of treatment with LCL161 alone.

The patients’ median age was 68 (range, 47-90), and they had a median of 3 prior therapies (range, 1-6). Forty-four percent of patients had high-risk features, 28% had relapsed disease, and 72% had relapsed and refractory disease.

Four patients experienced grade 2 cytokine release syndrome when they received LCL161 at a dose of 1800 mg weekly, so the dose was lowered to 1200 mg.

None of the patients responded to single-agent LCL161. So 23 of the patients received 500 mg of weekly cyclophosphamide as well.

There was 1 complete response to the combination therapy, 1 very good partial response, 2 partial responses, and 1 minimal response. The median progression-free survival in these patients was 10 months.

Grade 3 adverse events included decrease in neutrophil count (28%), decrease in lymphocyte count (28%), anemia (24%), fatigue (16%), hyperglycemia (12%), syncope (12%), decrease in white blood cell count (12%), decrease in platelet count (8%), increase in lymphocyte count (8%), nausea (4%), vomiting (4%), diarrhea (4%), maculo-papular rash (4%), hypotension (4%), lung infection (4%), pain in extremity (4%), and urticaria (4%).

Grade 4 events included decrease in lymphocyte count (24%), decrease in neutrophil count (8%), decrease in white blood cell count (8%), hyperuricemia (4%), decrease in platelet count (4%), and sepsis (4%).

Based on these results, the investigators said the combination of LCL161 and cyclophosphamide is “an attractive platform for future trials,” and the same is true for LCL161 in combination with anti-PD1 therapy.

The phase 2 trial was sponsored by Mayo Clinic and the National Cancer Institute. Novartis provided LCL161 for this research and supported the trial. 

Lab mouse

An experimental drug called LCL161 stimulates the immune system to fight multiple myeloma (MM), according to research published in Nature Medicine.

Investigators said LCL161 exhibited “robust” activity in a transgenic myeloma mouse model and in patients with relapsed/refractory MM.

Single-agent LCL161 did not produce responses in MM patients, but patients did respond to treatment with LCL161 and cyclophosphamide.

The investigators also found that single-agent LCL161 provided “long-term anti-tumor protection” in mice, and combining LCL161 with an antibody against PD-1 could cure mice of MM.

“The drug, LCL161, was initially developed to promote tumor death,” said study author Marta Chesi, PhD, of Mayo Clinic Arizona in Scottsdale.

“However, we found that the drug does not kill tumor cells directly. Rather, it makes them more visible to the immune system that recognizes them as foreign invaders and eliminates them.”

Dr Chesi and her colleagues explained that the cellular inhibitors of apoptosis (cIAP) 1 and 2 have been identified as potential therapeutic targets in some cancers.

And LCL161 is a small-molecule IAP antagonist that induces tumor necrosis factor-mediated apoptosis in cancer cells. However, the investigators found that LCL161 was not directly cytotoxic to MM cells.

Instead, the drug upregulated tumor-cell-autonomous type I interferon signaling and induced an acute inflammatory response. This led to the activation of macrophages and dendritic cells, which prompted phagocytosis in MM cells.

Results in mice

The investigators first tested LCL161 alone (at a dose previously shown to be well-tolerated) in Vk*MYC transgenic mice with established MM.

The team said they observed a reduction in tumor burden that was comparable to that observed in response to drugs currently used to treat MM—carfilzomib, bortezomib, melphalan, cyclophosphamide, panobinostat, dexamethasone, and pomalidomide.

The investigators then tested the combination of LCL161 and a PD1 antibody in Vk12598-tumor-bearing mice.

The team said the combination was curative in all mice that completed 2 weeks of treatment. In fact, it was more effective than combination treatment with LCL161 and cyclophosphamide.

Results in patients

Dr Chesi and her colleagues conducted a phase 2 trial of LCL161 in 25 patients with relapsed/refractory MM. Patients could receive cyclophosphamide if they failed to respond or progressed after 8 weeks of treatment with LCL161 alone.

The patients’ median age was 68 (range, 47-90), and they had a median of 3 prior therapies (range, 1-6). Forty-four percent of patients had high-risk features, 28% had relapsed disease, and 72% had relapsed and refractory disease.

Four patients experienced grade 2 cytokine release syndrome when they received LCL161 at a dose of 1800 mg weekly, so the dose was lowered to 1200 mg.

None of the patients responded to single-agent LCL161. So 23 of the patients received 500 mg of weekly cyclophosphamide as well.

There was 1 complete response to the combination therapy, 1 very good partial response, 2 partial responses, and 1 minimal response. The median progression-free survival in these patients was 10 months.

Grade 3 adverse events included decrease in neutrophil count (28%), decrease in lymphocyte count (28%), anemia (24%), fatigue (16%), hyperglycemia (12%), syncope (12%), decrease in white blood cell count (12%), decrease in platelet count (8%), increase in lymphocyte count (8%), nausea (4%), vomiting (4%), diarrhea (4%), maculo-papular rash (4%), hypotension (4%), lung infection (4%), pain in extremity (4%), and urticaria (4%).

Grade 4 events included decrease in lymphocyte count (24%), decrease in neutrophil count (8%), decrease in white blood cell count (8%), hyperuricemia (4%), decrease in platelet count (4%), and sepsis (4%).

Based on these results, the investigators said the combination of LCL161 and cyclophosphamide is “an attractive platform for future trials,” and the same is true for LCL161 in combination with anti-PD1 therapy.

The phase 2 trial was sponsored by Mayo Clinic and the National Cancer Institute. Novartis provided LCL161 for this research and supported the trial.