Federal Practitioner

Nick Burwick, MD, summarizes a series of topics to be addressed at the AVAHO 2022 annual meeting, including provider well-being, patient experience, multidisciplinary reflective care, and precision oncology.

In addition to the exciting presentations and sessions, Dr Burwick invokes the more informal aspects of AVAHO 2022, such as meeting colleagues and friends and taking the time to appreciate the host city of San Diego. Above all, Dr Burwick underscores this year’s theme of self-care and resilience in the cancer care setting.

Nick Burwick, MD, summarizes a series of topics to be addressed at the AVAHO 2022 annual meeting, including provider well-being, patient experience, multidisciplinary reflective care, and precision oncology.

In addition to the exciting presentations and sessions, Dr Burwick invokes the more informal aspects of AVAHO 2022, such as meeting colleagues and friends and taking the time to appreciate the host city of San Diego. Above all, Dr Burwick underscores this year’s theme of self-care and resilience in the cancer care setting.

Nick Burwick, MD, summarizes a series of topics to be addressed at the AVAHO 2022 annual meeting, including provider well-being, patient experience, multidisciplinary reflective care, and precision oncology.

In addition to the exciting presentations and sessions, Dr Burwick invokes the more informal aspects of AVAHO 2022, such as meeting colleagues and friends and taking the time to appreciate the host city of San Diego. Above all, Dr Burwick underscores this year’s theme of self-care and resilience in the cancer care setting.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

The unfortunate death of Lori McClintock, wife of northern California congressman Tom McClintock, shortly after consuming the herbal remedy white mulberry leaf on Dec. 15, 2021, gives us the opportunity to discuss how to better protect the American public from nutritional supplements with claims to aid health. Mulberry leaf has been purported to lower blood glucose levels, cholesterol, and inflammation as well as promote weight loss.

Many people desire to improve their health with concoctions purported to be “natural” or “from nature” instead of seeing a doctor and taking a medication or other therapy that is evidenced-based and backed by approval from the Food and Drug Administration. With the burgeoning prevalence of obesity and type 2 diabetes in this country (and worldwide) and the lack of a magic bullet that can stop the progression of these life-threatening diseases, many Americans turn to herbal and nutritional supplements that claim to promote weight loss and improve health.

Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) has allowed manufacturers of herbal and nutritional supplements to be “off the radar” of government regulators, unless their products have been shown to do harm – which is the government’s burden to prove.

A dietary supplement is defined as a product containing one or more vitamin, mineral, herb, or other botanical; amino acid; or other substance that would increase the total dietary intake of that product.

DSHEA exempted dietary supplements from the rigorous safety and efficacy testing that medications must undergo for various disease states, which is regulated by the FDA.
 

People with obesity may fall prey to dietary supplements’ claims

Persons suffering from obesity and its metabolic sequelae may be susceptible to the claims of dietary supplements because:

• The stigma associated with obesity, including the lack of understanding that obesity is a disease not under a person’s control, may make those with the disease wish to remedy it on their own out of shame and peer pressure.
• Clinicians and doctors traditionally have not been trained in obesity medicine so they aren’t comfortable treating obesity.
• It’s only fairly recently that obesity was recognized as a disease, so many insurance companies still don’t reimburse for obesity treatments, including the agents that can suppress appetite and result in weight loss.

For all of these reasons and more, only 2% or less of the millions of Americans suffering from obesity are treated with an antiobesity agent each year.

This has paved the way for the dietary supplement industry to prey on a desperate population, in much the same way that fad diets continue to attract multitudes of Americans. These supplements, however, carry much more risk than fad diets.

The solution, of course, is better regulation of the supplement industry, but it’s also improvement of how obesity is treated by the medical community.
 

How can clinicians and the community help?

Government, academic, community, clinical, and lay persons are more frequently recognizing obesity as a disease. Stigma will slowly come to a halt, as it has for other diseases such as depression and addiction to alcohol and drugs. Medications that have undergone rigorous testing for safety and efficacy eventually will be prescribed more and covered by healthcare insurance. Clinicians, and specifically physicians, are the most trusted persons in terms of giving medical advice. We need to ask patients whether they are taking supplements and be vocal about their lack of protection against harm, as allowed by DSHEA.

It would not be overkill to add prompts to the medical record to ask patients not only about smoking, alcohol, and drug use but also about supplements of all kinds. Some medical records do use these prompts but they are not as ubiquitous as those for smoking, alcohol, and drug use.

The supplement industry is powerful, but so is the medical industry when it comes to lobbying for change. It is ironic that Lori McClintock was the wife of a congressman. Perhaps the silver lining is future work toward legislation advocating for an end to these tragic deaths from poorly regulated supplements. Alignment with government in pushing for stricter regulations could save lives in the future.

Dr. Apovian is a faculty member, department of medicine, division of endocrinology, diabetes, and hypertension; and codirector, Center for Weight Management and Wellness, Boston. She disclosed ties with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.



A version of this article first appeared on Medscape.com.

The unfortunate death of Lori McClintock, wife of northern California congressman Tom McClintock, shortly after consuming the herbal remedy white mulberry leaf on Dec. 15, 2021, gives us the opportunity to discuss how to better protect the American public from nutritional supplements with claims to aid health. Mulberry leaf has been purported to lower blood glucose levels, cholesterol, and inflammation as well as promote weight loss.

Many people desire to improve their health with concoctions purported to be “natural” or “from nature” instead of seeing a doctor and taking a medication or other therapy that is evidenced-based and backed by approval from the Food and Drug Administration. With the burgeoning prevalence of obesity and type 2 diabetes in this country (and worldwide) and the lack of a magic bullet that can stop the progression of these life-threatening diseases, many Americans turn to herbal and nutritional supplements that claim to promote weight loss and improve health.

Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) has allowed manufacturers of herbal and nutritional supplements to be “off the radar” of government regulators, unless their products have been shown to do harm – which is the government’s burden to prove.

A dietary supplement is defined as a product containing one or more vitamin, mineral, herb, or other botanical; amino acid; or other substance that would increase the total dietary intake of that product.

DSHEA exempted dietary supplements from the rigorous safety and efficacy testing that medications must undergo for various disease states, which is regulated by the FDA.
 

People with obesity may fall prey to dietary supplements’ claims

Persons suffering from obesity and its metabolic sequelae may be susceptible to the claims of dietary supplements because:

• The stigma associated with obesity, including the lack of understanding that obesity is a disease not under a person’s control, may make those with the disease wish to remedy it on their own out of shame and peer pressure.
• Clinicians and doctors traditionally have not been trained in obesity medicine so they aren’t comfortable treating obesity.
• It’s only fairly recently that obesity was recognized as a disease, so many insurance companies still don’t reimburse for obesity treatments, including the agents that can suppress appetite and result in weight loss.

For all of these reasons and more, only 2% or less of the millions of Americans suffering from obesity are treated with an antiobesity agent each year.

This has paved the way for the dietary supplement industry to prey on a desperate population, in much the same way that fad diets continue to attract multitudes of Americans. These supplements, however, carry much more risk than fad diets.

The solution, of course, is better regulation of the supplement industry, but it’s also improvement of how obesity is treated by the medical community.
 

How can clinicians and the community help?

Government, academic, community, clinical, and lay persons are more frequently recognizing obesity as a disease. Stigma will slowly come to a halt, as it has for other diseases such as depression and addiction to alcohol and drugs. Medications that have undergone rigorous testing for safety and efficacy eventually will be prescribed more and covered by healthcare insurance. Clinicians, and specifically physicians, are the most trusted persons in terms of giving medical advice. We need to ask patients whether they are taking supplements and be vocal about their lack of protection against harm, as allowed by DSHEA.

It would not be overkill to add prompts to the medical record to ask patients not only about smoking, alcohol, and drug use but also about supplements of all kinds. Some medical records do use these prompts but they are not as ubiquitous as those for smoking, alcohol, and drug use.

The supplement industry is powerful, but so is the medical industry when it comes to lobbying for change. It is ironic that Lori McClintock was the wife of a congressman. Perhaps the silver lining is future work toward legislation advocating for an end to these tragic deaths from poorly regulated supplements. Alignment with government in pushing for stricter regulations could save lives in the future.

Dr. Apovian is a faculty member, department of medicine, division of endocrinology, diabetes, and hypertension; and codirector, Center for Weight Management and Wellness, Boston. She disclosed ties with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.



A version of this article first appeared on Medscape.com.

The unfortunate death of Lori McClintock, wife of northern California congressman Tom McClintock, shortly after consuming the herbal remedy white mulberry leaf on Dec. 15, 2021, gives us the opportunity to discuss how to better protect the American public from nutritional supplements with claims to aid health. Mulberry leaf has been purported to lower blood glucose levels, cholesterol, and inflammation as well as promote weight loss.

Many people desire to improve their health with concoctions purported to be “natural” or “from nature” instead of seeing a doctor and taking a medication or other therapy that is evidenced-based and backed by approval from the Food and Drug Administration. With the burgeoning prevalence of obesity and type 2 diabetes in this country (and worldwide) and the lack of a magic bullet that can stop the progression of these life-threatening diseases, many Americans turn to herbal and nutritional supplements that claim to promote weight loss and improve health.

Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) has allowed manufacturers of herbal and nutritional supplements to be “off the radar” of government regulators, unless their products have been shown to do harm – which is the government’s burden to prove.

A dietary supplement is defined as a product containing one or more vitamin, mineral, herb, or other botanical; amino acid; or other substance that would increase the total dietary intake of that product.

DSHEA exempted dietary supplements from the rigorous safety and efficacy testing that medications must undergo for various disease states, which is regulated by the FDA.
 

People with obesity may fall prey to dietary supplements’ claims

Persons suffering from obesity and its metabolic sequelae may be susceptible to the claims of dietary supplements because:

• The stigma associated with obesity, including the lack of understanding that obesity is a disease not under a person’s control, may make those with the disease wish to remedy it on their own out of shame and peer pressure.
• Clinicians and doctors traditionally have not been trained in obesity medicine so they aren’t comfortable treating obesity.
• It’s only fairly recently that obesity was recognized as a disease, so many insurance companies still don’t reimburse for obesity treatments, including the agents that can suppress appetite and result in weight loss.

For all of these reasons and more, only 2% or less of the millions of Americans suffering from obesity are treated with an antiobesity agent each year.

This has paved the way for the dietary supplement industry to prey on a desperate population, in much the same way that fad diets continue to attract multitudes of Americans. These supplements, however, carry much more risk than fad diets.

The solution, of course, is better regulation of the supplement industry, but it’s also improvement of how obesity is treated by the medical community.
 

How can clinicians and the community help?

Government, academic, community, clinical, and lay persons are more frequently recognizing obesity as a disease. Stigma will slowly come to a halt, as it has for other diseases such as depression and addiction to alcohol and drugs. Medications that have undergone rigorous testing for safety and efficacy eventually will be prescribed more and covered by healthcare insurance. Clinicians, and specifically physicians, are the most trusted persons in terms of giving medical advice. We need to ask patients whether they are taking supplements and be vocal about their lack of protection against harm, as allowed by DSHEA.

It would not be overkill to add prompts to the medical record to ask patients not only about smoking, alcohol, and drug use but also about supplements of all kinds. Some medical records do use these prompts but they are not as ubiquitous as those for smoking, alcohol, and drug use.

The supplement industry is powerful, but so is the medical industry when it comes to lobbying for change. It is ironic that Lori McClintock was the wife of a congressman. Perhaps the silver lining is future work toward legislation advocating for an end to these tragic deaths from poorly regulated supplements. Alignment with government in pushing for stricter regulations could save lives in the future.

Dr. Apovian is a faculty member, department of medicine, division of endocrinology, diabetes, and hypertension; and codirector, Center for Weight Management and Wellness, Boston. She disclosed ties with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.



A version of this article first appeared on Medscape.com.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Both yoga and cognitive-behavioral therapy (CBT) provide meaningful improvements in worry, anxiety, and insomnia in older adults that last even 6 months after discontinuing treatment, new research suggests.

The study is the first to compare the long-term effects from the two interventions; and the results offer clinicians and patients two effective choices for reducing worry and anxiety, researchers noted.

“Anxiety can be a really big problem for older adults,” lead investigator Suzanne Danhauer, PhD, professor of social sciences and health policy at Wake Forest University, Winston-Salem, N.C., said in an interview.

“So to find something they can do that lasts ... and has some enduring impact on their quality of life and their mental health, and they’re both nonpharmacologic treatments, I think for a lot of older people that’s really attractive,” Dr. Danhauer said.

The findings are published in the September issue of the American Journal of Geriatric Psychiatry.
 

Long-term benefits

The two-stage randomized preference trial included 500 community-dwelling individuals over age 60 who scored 26 or above on the Penn State Worry Questionnaire–Abbreviated (PSWQ-A), indicating heightened anxiety and worry.

Half the group took part in a randomized, controlled trial comparing CBT (n = 125) with yoga (n = 125). The other half participated in a preference trial where they were allowed to choose between CBT (n = 120) and yoga (n = 130).

Participants completed 20 yoga sessions over 10 weeks or 10 weekly CBT calls between May 2017 and November 2018.

Measures used included the PSWQ-A, the Insomnia Severity Index (ISI), the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 – Anxiety 8a, and the PROMIS-29 to assess depression, fatigue, physical function, social participation, and pain.

In 2020, the researchers published results at 11 weeks showing improvements from baseline in all areas. The scores for anxiety and worry were similar between the CBT and yoga groups, but CBT yielded significantly higher improvement in insomnia.

At 37 weeks, about 6 months after the interventions had ended, the investigators found even greater improvements from baseline in all areas measured – except physical function.

However, at that point, there were no significant differences between the two interventions in either the randomized controlled trial or the preference trial. There were also no differences in the results between the two trial designs.

“There were some little differences, but by and large we found both interventions to be efficacious,” Dr. Danhauer said. “This gives clinicians [the] choice to be able to say, ‘you can try either one of these and they’re probably going to help.’ ”
 

Beyond statistically significant

The researchers also found the improvements were not just statistically significant, but were also clinically meaningful for worry, anxiety, and insomnia.

Meaningful changes were defined as a decrease of at least 5.5 points on the PSWQ-A for worry, a decrease of at least 3 points on the PROMIS Anxiety scale for anxiety, and a decrease of at least 6 points in the ISI for insomnia.

At long-term follow-up, the majority of participants in both the CBT and yoga arms of the randomized, controlled trial demonstrated meaningful change in worry (85.7% and 77.6%, respectively), anxiety (82.1% and 80.8%), and insomnia (52.8% and 44.3%).

The majority of participants also reported meaningful improvements in generalized anxiety symptoms, depressive symptoms, and fatigue, but not for physical function, pain interference, or pain intensity.

“That’s the part to me that’s particularly notable. The improvements weren’t just statistically significant, they were clinically meaningful as well,” Dr. Danhauer said.

“When it comes right down to people’s lives, they want differences they can feel and see and not just what a P value looks like,” she added.
 

Real-world impact

In an accompanying editorial, Carmen Andreescu, MD, associate professor of psychiatry at the University of Pittsburgh, agreed that the results have “real-world impact.”

“Clinicians can direct their patients toward interventions that may be beneficial, consolidate the results over time and avoid fueling the well-trained worry cognitive loop with concerns related to potential side effects,” Dr. Andreescu wrote.

She adds that interventions such as these “may increase accessibility and provide relief for the immediate suffering of our patients.”

The study was funded by the Patient-Centered Outcomes Research Institute Program. Dr. Danhauer and Dr. Andreescu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Both yoga and cognitive-behavioral therapy (CBT) provide meaningful improvements in worry, anxiety, and insomnia in older adults that last even 6 months after discontinuing treatment, new research suggests.

The study is the first to compare the long-term effects from the two interventions; and the results offer clinicians and patients two effective choices for reducing worry and anxiety, researchers noted.

“Anxiety can be a really big problem for older adults,” lead investigator Suzanne Danhauer, PhD, professor of social sciences and health policy at Wake Forest University, Winston-Salem, N.C., said in an interview.

“So to find something they can do that lasts ... and has some enduring impact on their quality of life and their mental health, and they’re both nonpharmacologic treatments, I think for a lot of older people that’s really attractive,” Dr. Danhauer said.

The findings are published in the September issue of the American Journal of Geriatric Psychiatry.
 

Long-term benefits

The two-stage randomized preference trial included 500 community-dwelling individuals over age 60 who scored 26 or above on the Penn State Worry Questionnaire–Abbreviated (PSWQ-A), indicating heightened anxiety and worry.

Half the group took part in a randomized, controlled trial comparing CBT (n = 125) with yoga (n = 125). The other half participated in a preference trial where they were allowed to choose between CBT (n = 120) and yoga (n = 130).

Participants completed 20 yoga sessions over 10 weeks or 10 weekly CBT calls between May 2017 and November 2018.

Measures used included the PSWQ-A, the Insomnia Severity Index (ISI), the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 – Anxiety 8a, and the PROMIS-29 to assess depression, fatigue, physical function, social participation, and pain.

In 2020, the researchers published results at 11 weeks showing improvements from baseline in all areas. The scores for anxiety and worry were similar between the CBT and yoga groups, but CBT yielded significantly higher improvement in insomnia.

At 37 weeks, about 6 months after the interventions had ended, the investigators found even greater improvements from baseline in all areas measured – except physical function.

However, at that point, there were no significant differences between the two interventions in either the randomized controlled trial or the preference trial. There were also no differences in the results between the two trial designs.

“There were some little differences, but by and large we found both interventions to be efficacious,” Dr. Danhauer said. “This gives clinicians [the] choice to be able to say, ‘you can try either one of these and they’re probably going to help.’ ”
 

Beyond statistically significant

The researchers also found the improvements were not just statistically significant, but were also clinically meaningful for worry, anxiety, and insomnia.

Meaningful changes were defined as a decrease of at least 5.5 points on the PSWQ-A for worry, a decrease of at least 3 points on the PROMIS Anxiety scale for anxiety, and a decrease of at least 6 points in the ISI for insomnia.

At long-term follow-up, the majority of participants in both the CBT and yoga arms of the randomized, controlled trial demonstrated meaningful change in worry (85.7% and 77.6%, respectively), anxiety (82.1% and 80.8%), and insomnia (52.8% and 44.3%).

The majority of participants also reported meaningful improvements in generalized anxiety symptoms, depressive symptoms, and fatigue, but not for physical function, pain interference, or pain intensity.

“That’s the part to me that’s particularly notable. The improvements weren’t just statistically significant, they were clinically meaningful as well,” Dr. Danhauer said.

“When it comes right down to people’s lives, they want differences they can feel and see and not just what a P value looks like,” she added.
 

Real-world impact

In an accompanying editorial, Carmen Andreescu, MD, associate professor of psychiatry at the University of Pittsburgh, agreed that the results have “real-world impact.”

“Clinicians can direct their patients toward interventions that may be beneficial, consolidate the results over time and avoid fueling the well-trained worry cognitive loop with concerns related to potential side effects,” Dr. Andreescu wrote.

She adds that interventions such as these “may increase accessibility and provide relief for the immediate suffering of our patients.”

The study was funded by the Patient-Centered Outcomes Research Institute Program. Dr. Danhauer and Dr. Andreescu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Both yoga and cognitive-behavioral therapy (CBT) provide meaningful improvements in worry, anxiety, and insomnia in older adults that last even 6 months after discontinuing treatment, new research suggests.

The study is the first to compare the long-term effects from the two interventions; and the results offer clinicians and patients two effective choices for reducing worry and anxiety, researchers noted.

“Anxiety can be a really big problem for older adults,” lead investigator Suzanne Danhauer, PhD, professor of social sciences and health policy at Wake Forest University, Winston-Salem, N.C., said in an interview.

“So to find something they can do that lasts ... and has some enduring impact on their quality of life and their mental health, and they’re both nonpharmacologic treatments, I think for a lot of older people that’s really attractive,” Dr. Danhauer said.

The findings are published in the September issue of the American Journal of Geriatric Psychiatry.
 

Long-term benefits

The two-stage randomized preference trial included 500 community-dwelling individuals over age 60 who scored 26 or above on the Penn State Worry Questionnaire–Abbreviated (PSWQ-A), indicating heightened anxiety and worry.

Half the group took part in a randomized, controlled trial comparing CBT (n = 125) with yoga (n = 125). The other half participated in a preference trial where they were allowed to choose between CBT (n = 120) and yoga (n = 130).

Participants completed 20 yoga sessions over 10 weeks or 10 weekly CBT calls between May 2017 and November 2018.

Measures used included the PSWQ-A, the Insomnia Severity Index (ISI), the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 – Anxiety 8a, and the PROMIS-29 to assess depression, fatigue, physical function, social participation, and pain.

In 2020, the researchers published results at 11 weeks showing improvements from baseline in all areas. The scores for anxiety and worry were similar between the CBT and yoga groups, but CBT yielded significantly higher improvement in insomnia.

At 37 weeks, about 6 months after the interventions had ended, the investigators found even greater improvements from baseline in all areas measured – except physical function.

However, at that point, there were no significant differences between the two interventions in either the randomized controlled trial or the preference trial. There were also no differences in the results between the two trial designs.

“There were some little differences, but by and large we found both interventions to be efficacious,” Dr. Danhauer said. “This gives clinicians [the] choice to be able to say, ‘you can try either one of these and they’re probably going to help.’ ”
 

Beyond statistically significant

The researchers also found the improvements were not just statistically significant, but were also clinically meaningful for worry, anxiety, and insomnia.

Meaningful changes were defined as a decrease of at least 5.5 points on the PSWQ-A for worry, a decrease of at least 3 points on the PROMIS Anxiety scale for anxiety, and a decrease of at least 6 points in the ISI for insomnia.

At long-term follow-up, the majority of participants in both the CBT and yoga arms of the randomized, controlled trial demonstrated meaningful change in worry (85.7% and 77.6%, respectively), anxiety (82.1% and 80.8%), and insomnia (52.8% and 44.3%).

The majority of participants also reported meaningful improvements in generalized anxiety symptoms, depressive symptoms, and fatigue, but not for physical function, pain interference, or pain intensity.

“That’s the part to me that’s particularly notable. The improvements weren’t just statistically significant, they were clinically meaningful as well,” Dr. Danhauer said.

“When it comes right down to people’s lives, they want differences they can feel and see and not just what a P value looks like,” she added.
 

Real-world impact

In an accompanying editorial, Carmen Andreescu, MD, associate professor of psychiatry at the University of Pittsburgh, agreed that the results have “real-world impact.”

“Clinicians can direct their patients toward interventions that may be beneficial, consolidate the results over time and avoid fueling the well-trained worry cognitive loop with concerns related to potential side effects,” Dr. Andreescu wrote.

She adds that interventions such as these “may increase accessibility and provide relief for the immediate suffering of our patients.”

The study was funded by the Patient-Centered Outcomes Research Institute Program. Dr. Danhauer and Dr. Andreescu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.