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ENT Multidisciplinary Workgroup
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Multimodal Treatment Approaches for Basaloid Squamous Cell Carcinoma of the Larynx
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
National Tele-Oncology High-Risk Breast Clinic Program
Background
Assess implementation outcomes of the National Tele-Oncology’s first high-risk breast clinic program, part of the Breast and Gynecological System of Excellence (BGSOE). Women Veterans are the fastest-growing demographic in the Veteran population. Breast cancer (BC) is the most prevalent cancer among women. An estimated 15% of women will be considered high risk for BC at some point during their lifetime. For these reasons, the BGSOE high-risk breast clinic offers screening and risk reduction care to women with an increased risk for BC.
Methods
We described the patients seen in the BGSOE high-risk breast clinic since its implementation in 2023. We collected demographic and geographic information, genetic testing status, imaging, and risk-reducing agents (RRA) use. We reported percentages for categorical variables, followed by the total number of patients in parenthesis.
Results
There are a total of 124 patients served since 2023 (123 female, 1 male). The average age was 44.6 years. 61.3% (76) of patients lived in an urban setting, while 38.7% (48) lived in rural areas. Most patients were White at 63.7% (79), followed by African American 20.2%(25), Other 5.6% (7), and Unknown/declined 10.5%(13). Regarding ethnicity, 9% (12) were Hispanic. The most common reasons for referral to the clinic were a family history of breast cancer 89.2% (111), followed by high-risk genetic pathogenic variants 5.6% (7), mammary dysplasia 3.2% (4), inconclusive imaging 0.8% (1) and personal history of radiation 0.8%(1). 2 patients were started on RRAs. 56% (70) of patients had genetic testing discussions. The clinic coordinated 50 mammograms and 10 breast MRIs.
Conclusions
We demonstrated the successful implementation of the BGSOE high-risk breast program. We reached multiple historically underserved populations, including a high percentage of rural and African American patients. We also facilitated breast MRIs. Similar to other studies, there was a low uptake of RRA in our clinic. BGSOE is now working on a clinical pathway to standardize RRA and breast imaging recommendations for high-risk women. There are many more women Veterans at risk for BC and future expansion of the highrisk breast clinic could further raise awareness of lifetime breast cancer risk and risk-reducing and surveillance options in Veterans.
Background
Assess implementation outcomes of the National Tele-Oncology’s first high-risk breast clinic program, part of the Breast and Gynecological System of Excellence (BGSOE). Women Veterans are the fastest-growing demographic in the Veteran population. Breast cancer (BC) is the most prevalent cancer among women. An estimated 15% of women will be considered high risk for BC at some point during their lifetime. For these reasons, the BGSOE high-risk breast clinic offers screening and risk reduction care to women with an increased risk for BC.
Methods
We described the patients seen in the BGSOE high-risk breast clinic since its implementation in 2023. We collected demographic and geographic information, genetic testing status, imaging, and risk-reducing agents (RRA) use. We reported percentages for categorical variables, followed by the total number of patients in parenthesis.
Results
There are a total of 124 patients served since 2023 (123 female, 1 male). The average age was 44.6 years. 61.3% (76) of patients lived in an urban setting, while 38.7% (48) lived in rural areas. Most patients were White at 63.7% (79), followed by African American 20.2%(25), Other 5.6% (7), and Unknown/declined 10.5%(13). Regarding ethnicity, 9% (12) were Hispanic. The most common reasons for referral to the clinic were a family history of breast cancer 89.2% (111), followed by high-risk genetic pathogenic variants 5.6% (7), mammary dysplasia 3.2% (4), inconclusive imaging 0.8% (1) and personal history of radiation 0.8%(1). 2 patients were started on RRAs. 56% (70) of patients had genetic testing discussions. The clinic coordinated 50 mammograms and 10 breast MRIs.
Conclusions
We demonstrated the successful implementation of the BGSOE high-risk breast program. We reached multiple historically underserved populations, including a high percentage of rural and African American patients. We also facilitated breast MRIs. Similar to other studies, there was a low uptake of RRA in our clinic. BGSOE is now working on a clinical pathway to standardize RRA and breast imaging recommendations for high-risk women. There are many more women Veterans at risk for BC and future expansion of the highrisk breast clinic could further raise awareness of lifetime breast cancer risk and risk-reducing and surveillance options in Veterans.
Background
Assess implementation outcomes of the National Tele-Oncology’s first high-risk breast clinic program, part of the Breast and Gynecological System of Excellence (BGSOE). Women Veterans are the fastest-growing demographic in the Veteran population. Breast cancer (BC) is the most prevalent cancer among women. An estimated 15% of women will be considered high risk for BC at some point during their lifetime. For these reasons, the BGSOE high-risk breast clinic offers screening and risk reduction care to women with an increased risk for BC.
Methods
We described the patients seen in the BGSOE high-risk breast clinic since its implementation in 2023. We collected demographic and geographic information, genetic testing status, imaging, and risk-reducing agents (RRA) use. We reported percentages for categorical variables, followed by the total number of patients in parenthesis.
Results
There are a total of 124 patients served since 2023 (123 female, 1 male). The average age was 44.6 years. 61.3% (76) of patients lived in an urban setting, while 38.7% (48) lived in rural areas. Most patients were White at 63.7% (79), followed by African American 20.2%(25), Other 5.6% (7), and Unknown/declined 10.5%(13). Regarding ethnicity, 9% (12) were Hispanic. The most common reasons for referral to the clinic were a family history of breast cancer 89.2% (111), followed by high-risk genetic pathogenic variants 5.6% (7), mammary dysplasia 3.2% (4), inconclusive imaging 0.8% (1) and personal history of radiation 0.8%(1). 2 patients were started on RRAs. 56% (70) of patients had genetic testing discussions. The clinic coordinated 50 mammograms and 10 breast MRIs.
Conclusions
We demonstrated the successful implementation of the BGSOE high-risk breast program. We reached multiple historically underserved populations, including a high percentage of rural and African American patients. We also facilitated breast MRIs. Similar to other studies, there was a low uptake of RRA in our clinic. BGSOE is now working on a clinical pathway to standardize RRA and breast imaging recommendations for high-risk women. There are many more women Veterans at risk for BC and future expansion of the highrisk breast clinic could further raise awareness of lifetime breast cancer risk and risk-reducing and surveillance options in Veterans.
Creating a Urology Prostate Cancer Note, a National Oncology and Surgery Office Collaboration for Prostate Cancer Clinical Pathway Utilization
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Inhaled Insulin Aids Patients With Fear of Needles
This transcript has been edited for clarity.
Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada.
Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.
One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.
Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles.
Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.
Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin?
James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.
The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.
I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.
I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.
Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.
Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.
Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin.
Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided.
Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.
That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.
What are your thoughts, Dr. Kim, based on this for your practice in primary care?
Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.
I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?
What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.
Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.
If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?
Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.
However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging.
On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.
Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge.
I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada.
Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.
One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.
Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles.
Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.
Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin?
James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.
The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.
I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.
I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.
Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.
Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.
Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin.
Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided.
Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.
That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.
What are your thoughts, Dr. Kim, based on this for your practice in primary care?
Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.
I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?
What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.
Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.
If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?
Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.
However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging.
On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.
Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge.
I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada.
Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.
One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.
Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles.
Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.
Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin?
James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.
The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.
I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.
I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.
Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.
Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.
Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin.
Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided.
Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.
That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.
What are your thoughts, Dr. Kim, based on this for your practice in primary care?
Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.
I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?
What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.
Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.
If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?
Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.
However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging.
On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.
Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge.
I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FROM ADA 2024
Baseline Patient-Reported Care Metrics in a VA Hematology/Oncology Clinic Prior to Implementation of the 4R (Right Information and Right Care for the Right Patient at the Right Time) Oncology Model
Background
The Jesse Brown Veterans Affairs Medical Center (JBVAMC) serves predominantly Black American veterans, many with significant psychosocial needs, who live in Chicago’s South and West sides and Northwest Indiana. The JBVAMC hematology/oncology clinic is adopting the 4R Oncology Model (Right Info/ Care/Patient/Time) for patient-facing care planning and self-management, to enhance supportive and health maintenance care delivery. In order to guide the integration of the 4R model, baseline data were collected regarding patients’ understanding of their disease, social determinants of health, and use of services offered by JBVAMC.
Methods
Patients at JBVAMC were surveyed from February 2023 to September 2023. As a small incentive, these veterans received a $25 gift card for their participation. Analysis was conducted using descriptive statistics.
Results
Survey response rate was 67% (30/45). Median age was 66 (range 38-80). The population was 93% male, 83% black, 57% with highest level of education being high school or less, 59% with annual income less than $30k, and 47% living alone. Less than half (43%) of respondents knew their stage of cancer at diagnosis, and only 63% were aware of their treatment goals. Furthermore, only 17% remember receiving recommendations for support services that may be available through JBVAMC such as transportation assistance and home care. Information regarding “emotional distress or worry support recommendations” was acquired by 24% of veteran respondents. More than half, 57%, of veterans were encouraged to talk to their primary care provider about routine health maintenance during cancer treatment. Just over a quarter, 27%, were referred to a dietician.
Conclusions
This survey uncovered gaps in care planning, supportive services, and health maintenance care. These data will serve as a baseline to assess the effectiveness of the 4R care plan model. The implementation of the 4R Oncology Model is designed to address these gaps by providing a personalized care sequence that establishes a clear roadmap through the patient’s care trajectory, ultimately enhancing patient-centered care. Post-intervention survey results will be shared when available.
Background
The Jesse Brown Veterans Affairs Medical Center (JBVAMC) serves predominantly Black American veterans, many with significant psychosocial needs, who live in Chicago’s South and West sides and Northwest Indiana. The JBVAMC hematology/oncology clinic is adopting the 4R Oncology Model (Right Info/ Care/Patient/Time) for patient-facing care planning and self-management, to enhance supportive and health maintenance care delivery. In order to guide the integration of the 4R model, baseline data were collected regarding patients’ understanding of their disease, social determinants of health, and use of services offered by JBVAMC.
Methods
Patients at JBVAMC were surveyed from February 2023 to September 2023. As a small incentive, these veterans received a $25 gift card for their participation. Analysis was conducted using descriptive statistics.
Results
Survey response rate was 67% (30/45). Median age was 66 (range 38-80). The population was 93% male, 83% black, 57% with highest level of education being high school or less, 59% with annual income less than $30k, and 47% living alone. Less than half (43%) of respondents knew their stage of cancer at diagnosis, and only 63% were aware of their treatment goals. Furthermore, only 17% remember receiving recommendations for support services that may be available through JBVAMC such as transportation assistance and home care. Information regarding “emotional distress or worry support recommendations” was acquired by 24% of veteran respondents. More than half, 57%, of veterans were encouraged to talk to their primary care provider about routine health maintenance during cancer treatment. Just over a quarter, 27%, were referred to a dietician.
Conclusions
This survey uncovered gaps in care planning, supportive services, and health maintenance care. These data will serve as a baseline to assess the effectiveness of the 4R care plan model. The implementation of the 4R Oncology Model is designed to address these gaps by providing a personalized care sequence that establishes a clear roadmap through the patient’s care trajectory, ultimately enhancing patient-centered care. Post-intervention survey results will be shared when available.
Background
The Jesse Brown Veterans Affairs Medical Center (JBVAMC) serves predominantly Black American veterans, many with significant psychosocial needs, who live in Chicago’s South and West sides and Northwest Indiana. The JBVAMC hematology/oncology clinic is adopting the 4R Oncology Model (Right Info/ Care/Patient/Time) for patient-facing care planning and self-management, to enhance supportive and health maintenance care delivery. In order to guide the integration of the 4R model, baseline data were collected regarding patients’ understanding of their disease, social determinants of health, and use of services offered by JBVAMC.
Methods
Patients at JBVAMC were surveyed from February 2023 to September 2023. As a small incentive, these veterans received a $25 gift card for their participation. Analysis was conducted using descriptive statistics.
Results
Survey response rate was 67% (30/45). Median age was 66 (range 38-80). The population was 93% male, 83% black, 57% with highest level of education being high school or less, 59% with annual income less than $30k, and 47% living alone. Less than half (43%) of respondents knew their stage of cancer at diagnosis, and only 63% were aware of their treatment goals. Furthermore, only 17% remember receiving recommendations for support services that may be available through JBVAMC such as transportation assistance and home care. Information regarding “emotional distress or worry support recommendations” was acquired by 24% of veteran respondents. More than half, 57%, of veterans were encouraged to talk to their primary care provider about routine health maintenance during cancer treatment. Just over a quarter, 27%, were referred to a dietician.
Conclusions
This survey uncovered gaps in care planning, supportive services, and health maintenance care. These data will serve as a baseline to assess the effectiveness of the 4R care plan model. The implementation of the 4R Oncology Model is designed to address these gaps by providing a personalized care sequence that establishes a clear roadmap through the patient’s care trajectory, ultimately enhancing patient-centered care. Post-intervention survey results will be shared when available.
Impact of Stewardship Assistance Pilot Program for Veterans on Adherence and Persistence to Oral mCRPC Therapies
Background
Given the poor prognosis of patients with metastatic castration-resistant prostate cancer (mCRPC), interventions aimed at increasing adherence to oral treatments have the potential to improve patient outcomes. This study evaluates the impact of a patient stewardship assistance pilot program (stewardship program) on the adherence and persistence to oral treatments among patients with mCRPC at VA medical centers (VAMCs).
Methods
A non-randomized controlled study design and data from the VA Corporate Data Warehouse were used. The study included patients treated with an oral mCRPC therapy (i.e., abiraterone acetate or enzalutamide) between 08/2018 and 12/2019. Patients participating in the stewardship program formed the intervention arm and patients not participating the controls. Control patients were selected and matched 1:3 based on age, race and index year. The index date was the date of initiation of abiraterone acetate or enzalutamide. Outcomes included persistence (no gap >60 days of supply) and adherence (proportion of days covered [PDC] ≥80%) to oral mCRPC treatment post-index. Persistence and adherence were compared between the two arms using a Cox proportional hazard model and logistic regression model, respectively, adjusted for baseline characteristics.
Results
The study included 108 intervention patients (mean age: 74.6, 19.4% Black or African American, 44.4% from South, mean Quan-CCI: 6.7) and 324 control patients (mean age: 74.6, 19.4% Black or African American, 31.5% from South, mean Quan-CCI: 6.2). There was no statistically significant difference in persistence between the intervention and control arms (hazard ratio [95% confidence interval]: 0.84 [0.66-1.10], p-value: 0.211), with respective median times to discontinuation of 18 and 19 months. Over the first 12 months post-index, the proportion of adherent patients was not significantly different between the intervention arm and the control arm (50.6% vs. 50.9%; odds ratio [95% confidence interval]: 1.05 [0.80-1.38], p-value: 0.729).
Conclusions
In this racially diverse study of patients treated at VAMCs, high levels of persistence and adherence to oral mCRPC therapy were observed. The absence of any significant difference in adherence and persistence from the study intervention suggests that a stewardship assistance program aimed at improving adherence and persistence of patients with mCRPC may not be required at VAMCs.
Background
Given the poor prognosis of patients with metastatic castration-resistant prostate cancer (mCRPC), interventions aimed at increasing adherence to oral treatments have the potential to improve patient outcomes. This study evaluates the impact of a patient stewardship assistance pilot program (stewardship program) on the adherence and persistence to oral treatments among patients with mCRPC at VA medical centers (VAMCs).
Methods
A non-randomized controlled study design and data from the VA Corporate Data Warehouse were used. The study included patients treated with an oral mCRPC therapy (i.e., abiraterone acetate or enzalutamide) between 08/2018 and 12/2019. Patients participating in the stewardship program formed the intervention arm and patients not participating the controls. Control patients were selected and matched 1:3 based on age, race and index year. The index date was the date of initiation of abiraterone acetate or enzalutamide. Outcomes included persistence (no gap >60 days of supply) and adherence (proportion of days covered [PDC] ≥80%) to oral mCRPC treatment post-index. Persistence and adherence were compared between the two arms using a Cox proportional hazard model and logistic regression model, respectively, adjusted for baseline characteristics.
Results
The study included 108 intervention patients (mean age: 74.6, 19.4% Black or African American, 44.4% from South, mean Quan-CCI: 6.7) and 324 control patients (mean age: 74.6, 19.4% Black or African American, 31.5% from South, mean Quan-CCI: 6.2). There was no statistically significant difference in persistence between the intervention and control arms (hazard ratio [95% confidence interval]: 0.84 [0.66-1.10], p-value: 0.211), with respective median times to discontinuation of 18 and 19 months. Over the first 12 months post-index, the proportion of adherent patients was not significantly different between the intervention arm and the control arm (50.6% vs. 50.9%; odds ratio [95% confidence interval]: 1.05 [0.80-1.38], p-value: 0.729).
Conclusions
In this racially diverse study of patients treated at VAMCs, high levels of persistence and adherence to oral mCRPC therapy were observed. The absence of any significant difference in adherence and persistence from the study intervention suggests that a stewardship assistance program aimed at improving adherence and persistence of patients with mCRPC may not be required at VAMCs.
Background
Given the poor prognosis of patients with metastatic castration-resistant prostate cancer (mCRPC), interventions aimed at increasing adherence to oral treatments have the potential to improve patient outcomes. This study evaluates the impact of a patient stewardship assistance pilot program (stewardship program) on the adherence and persistence to oral treatments among patients with mCRPC at VA medical centers (VAMCs).
Methods
A non-randomized controlled study design and data from the VA Corporate Data Warehouse were used. The study included patients treated with an oral mCRPC therapy (i.e., abiraterone acetate or enzalutamide) between 08/2018 and 12/2019. Patients participating in the stewardship program formed the intervention arm and patients not participating the controls. Control patients were selected and matched 1:3 based on age, race and index year. The index date was the date of initiation of abiraterone acetate or enzalutamide. Outcomes included persistence (no gap >60 days of supply) and adherence (proportion of days covered [PDC] ≥80%) to oral mCRPC treatment post-index. Persistence and adherence were compared between the two arms using a Cox proportional hazard model and logistic regression model, respectively, adjusted for baseline characteristics.
Results
The study included 108 intervention patients (mean age: 74.6, 19.4% Black or African American, 44.4% from South, mean Quan-CCI: 6.7) and 324 control patients (mean age: 74.6, 19.4% Black or African American, 31.5% from South, mean Quan-CCI: 6.2). There was no statistically significant difference in persistence between the intervention and control arms (hazard ratio [95% confidence interval]: 0.84 [0.66-1.10], p-value: 0.211), with respective median times to discontinuation of 18 and 19 months. Over the first 12 months post-index, the proportion of adherent patients was not significantly different between the intervention arm and the control arm (50.6% vs. 50.9%; odds ratio [95% confidence interval]: 1.05 [0.80-1.38], p-value: 0.729).
Conclusions
In this racially diverse study of patients treated at VAMCs, high levels of persistence and adherence to oral mCRPC therapy were observed. The absence of any significant difference in adherence and persistence from the study intervention suggests that a stewardship assistance program aimed at improving adherence and persistence of patients with mCRPC may not be required at VAMCs.
Unexpected Findings: A Rare Case of Signet Ring Cell Adenocarcinoma in the Small Intestine
Introduction
Signet ring cell carcinoma (SRCC) of the small intestine is very rare. It is characterized by the presence of malignant cells that contain mucin that push nuclei to the periphery. It is more aggressive compared to other adenocarcinomas due to early metastasis and poorer prognosis.
Case Presentation
A 59-year-old male with a history of HIV/AIDS, presented with complaints of anorexia, vomiting and weight loss. Initial abdominal CT showed a retroperitoneal mass causing gastric outlet obstruction. The patient elected to go home after supportive treatment and follow up as an outpatient, however, he presented 10 days later with worsening symptoms. Evaluation with CT abdomen and pelvis showed enlarging soft tissue density in the retrocrural space extending into the retroperitoneum around the aorta, as well as a 1.5 cm intraluminal cystic lesion in the duodenum. Endoscopic ultrasound revealed lymphadenopathy of celiac and porta hepatis regions, along with duodenal stenosis, stent placement for decompression was not feasible and biopsies were inconclusive. The decision was made to proceed with laparotomy for decompression and additional biopsies from the retroperitoneal mass and omental lymph nodes, which confirmed poorly differentiated adenocarcinoma with signet ring cells. The presence of a mass in the duodenum strongly suggested adenocarcinoma of small intestine origin. As the patient’s symptoms worsened, imaging revealed progression with lung metastases. The patient continued to deteriorate rapidly requiring dialysis and gangrenous cholecystitis. Given his complex medical history, patient decided to transition to comfort care.
Discussion
SRCC can present with any GI symptoms. Most important step in diagnosing SRCC is biopsy. Current treatment options for small intestinal malignancies include wide resection that includes the mesentery and corresponding lymph nodes. The use of adjuvant chemotherapy has been described only in small retrospective studies. Due to its scarcity, there isn’t sufficient data for optimal treatment strategies compared to gastric SRCC.
Conclusions
This case report highlights the importance of how rare and aggressive signet ring cell adenocarcinoma of the small intestine. There are only a few cases documented in the literature, which is why we lack data on how to manage the disease.
Introduction
Signet ring cell carcinoma (SRCC) of the small intestine is very rare. It is characterized by the presence of malignant cells that contain mucin that push nuclei to the periphery. It is more aggressive compared to other adenocarcinomas due to early metastasis and poorer prognosis.
Case Presentation
A 59-year-old male with a history of HIV/AIDS, presented with complaints of anorexia, vomiting and weight loss. Initial abdominal CT showed a retroperitoneal mass causing gastric outlet obstruction. The patient elected to go home after supportive treatment and follow up as an outpatient, however, he presented 10 days later with worsening symptoms. Evaluation with CT abdomen and pelvis showed enlarging soft tissue density in the retrocrural space extending into the retroperitoneum around the aorta, as well as a 1.5 cm intraluminal cystic lesion in the duodenum. Endoscopic ultrasound revealed lymphadenopathy of celiac and porta hepatis regions, along with duodenal stenosis, stent placement for decompression was not feasible and biopsies were inconclusive. The decision was made to proceed with laparotomy for decompression and additional biopsies from the retroperitoneal mass and omental lymph nodes, which confirmed poorly differentiated adenocarcinoma with signet ring cells. The presence of a mass in the duodenum strongly suggested adenocarcinoma of small intestine origin. As the patient’s symptoms worsened, imaging revealed progression with lung metastases. The patient continued to deteriorate rapidly requiring dialysis and gangrenous cholecystitis. Given his complex medical history, patient decided to transition to comfort care.
Discussion
SRCC can present with any GI symptoms. Most important step in diagnosing SRCC is biopsy. Current treatment options for small intestinal malignancies include wide resection that includes the mesentery and corresponding lymph nodes. The use of adjuvant chemotherapy has been described only in small retrospective studies. Due to its scarcity, there isn’t sufficient data for optimal treatment strategies compared to gastric SRCC.
Conclusions
This case report highlights the importance of how rare and aggressive signet ring cell adenocarcinoma of the small intestine. There are only a few cases documented in the literature, which is why we lack data on how to manage the disease.
Introduction
Signet ring cell carcinoma (SRCC) of the small intestine is very rare. It is characterized by the presence of malignant cells that contain mucin that push nuclei to the periphery. It is more aggressive compared to other adenocarcinomas due to early metastasis and poorer prognosis.
Case Presentation
A 59-year-old male with a history of HIV/AIDS, presented with complaints of anorexia, vomiting and weight loss. Initial abdominal CT showed a retroperitoneal mass causing gastric outlet obstruction. The patient elected to go home after supportive treatment and follow up as an outpatient, however, he presented 10 days later with worsening symptoms. Evaluation with CT abdomen and pelvis showed enlarging soft tissue density in the retrocrural space extending into the retroperitoneum around the aorta, as well as a 1.5 cm intraluminal cystic lesion in the duodenum. Endoscopic ultrasound revealed lymphadenopathy of celiac and porta hepatis regions, along with duodenal stenosis, stent placement for decompression was not feasible and biopsies were inconclusive. The decision was made to proceed with laparotomy for decompression and additional biopsies from the retroperitoneal mass and omental lymph nodes, which confirmed poorly differentiated adenocarcinoma with signet ring cells. The presence of a mass in the duodenum strongly suggested adenocarcinoma of small intestine origin. As the patient’s symptoms worsened, imaging revealed progression with lung metastases. The patient continued to deteriorate rapidly requiring dialysis and gangrenous cholecystitis. Given his complex medical history, patient decided to transition to comfort care.
Discussion
SRCC can present with any GI symptoms. Most important step in diagnosing SRCC is biopsy. Current treatment options for small intestinal malignancies include wide resection that includes the mesentery and corresponding lymph nodes. The use of adjuvant chemotherapy has been described only in small retrospective studies. Due to its scarcity, there isn’t sufficient data for optimal treatment strategies compared to gastric SRCC.
Conclusions
This case report highlights the importance of how rare and aggressive signet ring cell adenocarcinoma of the small intestine. There are only a few cases documented in the literature, which is why we lack data on how to manage the disease.
Registered Dietitian Staffing and Nutrition Practices in High-Risk Cancer Patients Across the Veterans Health Administration
Background
Nutrition disorders, such as sarcopenia, malnutrition, and cachexia are prevalent in cancer patients and correlated with negative outcomes, increased costs, and reduced quality of life (QOL). Registered dietitians (RDs) effectively diagnose and treat nutrition disorders. RD staffing guidelines in outpatient cancer centers are non-specific and unvalidated. This study explored RD staffing ratios to determine trends which may indicate best practices.
Methods
Facility-level measures including full time equivalents (FTE), referral practices, RD participation interdisciplinary round participation, and nutrition referral practices were obtained from survey data of RDs working in oncology clinics and from cancer registries across VHA between 2016-2017. A proactive score was calculated based on interdisciplinary meeting attendances, use of validated screening tools, and standardized protocols for nutrition referrals. Chart review was conducted for 681 Veterans from 13 VHA cancer centers and 207 oncology providers (OPs) to determine weight change, malnutrition, oral nutrition supplement (ONS) use, time to RD referral, and survival. Logistic regression was used for statistical analysis.
Results
Mean and median RD FTE assigned to oncology clinics was 0.5. The total RD:OP ratio ranged from 1:4 to 1:850 with an average of 1 RD to 48.5 OP. An increase in RD:OP ratio from 0:1 to 1:1 was associated with a 16-fold increased odds of weight maintenance during cancer treatment (95% CI: 2.01, 127.53). A 10% increase in the RD:OP ratio increased probability of weight maintenance by 32%. Being seen by an RD was associated with 2.87 times odds of being diagnosed with malnutrition (95% CI: 1.62, 5.08). Each unit increase in a facility’s proactive score was associated with 38% increased odds of a patient being seen by an RD (95% CI: 1.08, 1.76), and 21% reduced odds of being prescribed an ONS (95% CI: 0.63, 0.98).
Conclusions
Few cancer centers employ dedicated fulltime RDs and nutrition practices vary across cancer centers. Improved RD:OP ratios may contribute to improved nutrition outcomes for this population. When RDs are active in interdisciplinary cancer teams, nutrition treatment improves. These efforts support patient complexity, facility funding, and QOL. These data may be used to support cancer care guidelines across VHA.
Background
Nutrition disorders, such as sarcopenia, malnutrition, and cachexia are prevalent in cancer patients and correlated with negative outcomes, increased costs, and reduced quality of life (QOL). Registered dietitians (RDs) effectively diagnose and treat nutrition disorders. RD staffing guidelines in outpatient cancer centers are non-specific and unvalidated. This study explored RD staffing ratios to determine trends which may indicate best practices.
Methods
Facility-level measures including full time equivalents (FTE), referral practices, RD participation interdisciplinary round participation, and nutrition referral practices were obtained from survey data of RDs working in oncology clinics and from cancer registries across VHA between 2016-2017. A proactive score was calculated based on interdisciplinary meeting attendances, use of validated screening tools, and standardized protocols for nutrition referrals. Chart review was conducted for 681 Veterans from 13 VHA cancer centers and 207 oncology providers (OPs) to determine weight change, malnutrition, oral nutrition supplement (ONS) use, time to RD referral, and survival. Logistic regression was used for statistical analysis.
Results
Mean and median RD FTE assigned to oncology clinics was 0.5. The total RD:OP ratio ranged from 1:4 to 1:850 with an average of 1 RD to 48.5 OP. An increase in RD:OP ratio from 0:1 to 1:1 was associated with a 16-fold increased odds of weight maintenance during cancer treatment (95% CI: 2.01, 127.53). A 10% increase in the RD:OP ratio increased probability of weight maintenance by 32%. Being seen by an RD was associated with 2.87 times odds of being diagnosed with malnutrition (95% CI: 1.62, 5.08). Each unit increase in a facility’s proactive score was associated with 38% increased odds of a patient being seen by an RD (95% CI: 1.08, 1.76), and 21% reduced odds of being prescribed an ONS (95% CI: 0.63, 0.98).
Conclusions
Few cancer centers employ dedicated fulltime RDs and nutrition practices vary across cancer centers. Improved RD:OP ratios may contribute to improved nutrition outcomes for this population. When RDs are active in interdisciplinary cancer teams, nutrition treatment improves. These efforts support patient complexity, facility funding, and QOL. These data may be used to support cancer care guidelines across VHA.
Background
Nutrition disorders, such as sarcopenia, malnutrition, and cachexia are prevalent in cancer patients and correlated with negative outcomes, increased costs, and reduced quality of life (QOL). Registered dietitians (RDs) effectively diagnose and treat nutrition disorders. RD staffing guidelines in outpatient cancer centers are non-specific and unvalidated. This study explored RD staffing ratios to determine trends which may indicate best practices.
Methods
Facility-level measures including full time equivalents (FTE), referral practices, RD participation interdisciplinary round participation, and nutrition referral practices were obtained from survey data of RDs working in oncology clinics and from cancer registries across VHA between 2016-2017. A proactive score was calculated based on interdisciplinary meeting attendances, use of validated screening tools, and standardized protocols for nutrition referrals. Chart review was conducted for 681 Veterans from 13 VHA cancer centers and 207 oncology providers (OPs) to determine weight change, malnutrition, oral nutrition supplement (ONS) use, time to RD referral, and survival. Logistic regression was used for statistical analysis.
Results
Mean and median RD FTE assigned to oncology clinics was 0.5. The total RD:OP ratio ranged from 1:4 to 1:850 with an average of 1 RD to 48.5 OP. An increase in RD:OP ratio from 0:1 to 1:1 was associated with a 16-fold increased odds of weight maintenance during cancer treatment (95% CI: 2.01, 127.53). A 10% increase in the RD:OP ratio increased probability of weight maintenance by 32%. Being seen by an RD was associated with 2.87 times odds of being diagnosed with malnutrition (95% CI: 1.62, 5.08). Each unit increase in a facility’s proactive score was associated with 38% increased odds of a patient being seen by an RD (95% CI: 1.08, 1.76), and 21% reduced odds of being prescribed an ONS (95% CI: 0.63, 0.98).
Conclusions
Few cancer centers employ dedicated fulltime RDs and nutrition practices vary across cancer centers. Improved RD:OP ratios may contribute to improved nutrition outcomes for this population. When RDs are active in interdisciplinary cancer teams, nutrition treatment improves. These efforts support patient complexity, facility funding, and QOL. These data may be used to support cancer care guidelines across VHA.
Telehealth Research and Innovation for Veterans With Cancer (THRIVE): Understanding Experiences of National TeleOncology Service Providers
Background
Currently within the Veterans Health Administration, nearly 38% of VA users reside in rural areas. Approximately 70% of rural areas do not have an oncologist, resulting in a high proportion of Veterans who lack access to specialized cancer services. The National TeleOncology Service (NTO) was designed to increase access to specialty and subspecialty cancer care for Veterans regardless of geographical location, and for those who may experience additional barriers to in-person care due to medical complexity or other social determinants of health. Purpose: THRIVE focuses on health equity for telehealth-delivered cancer care. We are specifically interested in the intersection of poverty, rurality, and race. As part of this inquiry, we examined provider experiences of the NTO to better understand the benefits, drawbacks, facilitators and barriers to implementing NTO care.
Methods
We conducted two focus groups with NTO providers. We developed guides using the Consolidated Framework for Implementation Research (CFIR 2.0) and utilized rapid qualitative analysis. We arrayed data in matrices based on CFIR 2.0-based guide for analysis.
Results
The focus groups included NTO physicians (n=4) and non-physicians (n=19). Providers agreed that NTO provides valuable cancer care to Veterans facing in-person access issues. The technology is easy to use for many patients, but those in rural areas experiencing poverty struggle most. NTO’s technical support resources reduce technical skill and equipment barriers and facilitate connection for both patients and providers. Providers enjoyed the team-based approach of NTO and believed it increases care quality through access to multiple providers and resources within the clinical encounter. The NTO’s work could be strengthened by standardizing technology to facilitate records transfer and enable sharing of documentation and education between NTO and patients. Implications: This study examined providers’ perceived acceptability, feasibility, barriers, and facilitators of NTO-delivered cancer care within VA, demonstrating that NTO service is well-liked and a valuable emerging resource of VA care.
Conclusions
In an era when CMMS shifts away from reimbursing telehealth, VA has committed to continue such care providing a variety of patient-centered approaches. NTO may serve as a model for expanding telehealth-delivered care for other serious and chronic diseases and conditions.
Background
Currently within the Veterans Health Administration, nearly 38% of VA users reside in rural areas. Approximately 70% of rural areas do not have an oncologist, resulting in a high proportion of Veterans who lack access to specialized cancer services. The National TeleOncology Service (NTO) was designed to increase access to specialty and subspecialty cancer care for Veterans regardless of geographical location, and for those who may experience additional barriers to in-person care due to medical complexity or other social determinants of health. Purpose: THRIVE focuses on health equity for telehealth-delivered cancer care. We are specifically interested in the intersection of poverty, rurality, and race. As part of this inquiry, we examined provider experiences of the NTO to better understand the benefits, drawbacks, facilitators and barriers to implementing NTO care.
Methods
We conducted two focus groups with NTO providers. We developed guides using the Consolidated Framework for Implementation Research (CFIR 2.0) and utilized rapid qualitative analysis. We arrayed data in matrices based on CFIR 2.0-based guide for analysis.
Results
The focus groups included NTO physicians (n=4) and non-physicians (n=19). Providers agreed that NTO provides valuable cancer care to Veterans facing in-person access issues. The technology is easy to use for many patients, but those in rural areas experiencing poverty struggle most. NTO’s technical support resources reduce technical skill and equipment barriers and facilitate connection for both patients and providers. Providers enjoyed the team-based approach of NTO and believed it increases care quality through access to multiple providers and resources within the clinical encounter. The NTO’s work could be strengthened by standardizing technology to facilitate records transfer and enable sharing of documentation and education between NTO and patients. Implications: This study examined providers’ perceived acceptability, feasibility, barriers, and facilitators of NTO-delivered cancer care within VA, demonstrating that NTO service is well-liked and a valuable emerging resource of VA care.
Conclusions
In an era when CMMS shifts away from reimbursing telehealth, VA has committed to continue such care providing a variety of patient-centered approaches. NTO may serve as a model for expanding telehealth-delivered care for other serious and chronic diseases and conditions.
Background
Currently within the Veterans Health Administration, nearly 38% of VA users reside in rural areas. Approximately 70% of rural areas do not have an oncologist, resulting in a high proportion of Veterans who lack access to specialized cancer services. The National TeleOncology Service (NTO) was designed to increase access to specialty and subspecialty cancer care for Veterans regardless of geographical location, and for those who may experience additional barriers to in-person care due to medical complexity or other social determinants of health. Purpose: THRIVE focuses on health equity for telehealth-delivered cancer care. We are specifically interested in the intersection of poverty, rurality, and race. As part of this inquiry, we examined provider experiences of the NTO to better understand the benefits, drawbacks, facilitators and barriers to implementing NTO care.
Methods
We conducted two focus groups with NTO providers. We developed guides using the Consolidated Framework for Implementation Research (CFIR 2.0) and utilized rapid qualitative analysis. We arrayed data in matrices based on CFIR 2.0-based guide for analysis.
Results
The focus groups included NTO physicians (n=4) and non-physicians (n=19). Providers agreed that NTO provides valuable cancer care to Veterans facing in-person access issues. The technology is easy to use for many patients, but those in rural areas experiencing poverty struggle most. NTO’s technical support resources reduce technical skill and equipment barriers and facilitate connection for both patients and providers. Providers enjoyed the team-based approach of NTO and believed it increases care quality through access to multiple providers and resources within the clinical encounter. The NTO’s work could be strengthened by standardizing technology to facilitate records transfer and enable sharing of documentation and education between NTO and patients. Implications: This study examined providers’ perceived acceptability, feasibility, barriers, and facilitators of NTO-delivered cancer care within VA, demonstrating that NTO service is well-liked and a valuable emerging resource of VA care.
Conclusions
In an era when CMMS shifts away from reimbursing telehealth, VA has committed to continue such care providing a variety of patient-centered approaches. NTO may serve as a model for expanding telehealth-delivered care for other serious and chronic diseases and conditions.