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Increase in message volume begs the question: ‘Should we be compensated for our time?’
The American Gastroenterological Association and other gastrointestinal-specific organizations have excellent resources available to members that focus on optimizing reimbursement in your clinical and endoscopic practice.
During the COVID-19 pandemic and public health emergency (PHE), many previously noncovered services were now covered under rules of the Centers for Medicare & Medicaid Services. During the pandemic, patient portal messages increased by 157%, meaning more work for health care teams, negatively impacting physician satisfaction, and increasing burnout.1 Medical burnout has been associated with increased time spent on electronic health records, with some subspeciality gastroenterology (GI) groups having a high EHR burden, according to a recently published article in the American Journal of Gastroenterology.2
This topic is a timely discussion as several large health systems have implemented processes to bill for non–face-to-face services (termed “asynchronous care”), some of which have not been well received in the lay media. It is important to note that despite these implementations, studies have shown only 1% of all incoming portal messages would meet criteria to be submitted for reimbursement. This impact might be slightly higher in chronic care management practices.
Providers and practices have several options when considering billing for non–face-to-face encounters, which we outline in Table 1.3
The focus of this article will be to review the more common non–face-to-face evaluation and management services, such as telephone E/M (patient phone call) and e-visits (patient portal messages) as these have recently generated the most interest and discussion amongst health care providers.
Telemedicine after COVID-19 pandemic
During the beginning of the pandemic, a web-based survey study found that almost all providers in GI practices implemented some form of telemedicine to continue to provide care for patients, compared to 32% prior to the pandemic.4,5 The high demand and essential requirement for telehealth evaluation facilitated its reimbursement, eliminating the primary barrier to previous use.6
One of the new covered benefits by CMS was asynchronous telehealth care.7 The PHE ended in May 2023, and since then a qualified health care provider (QHCP) does not have the full flexibility to deliver telemedicine services across state lines. The U.S. Department of Health and Human Services has considered some telehealth policy changes after the COVID-19 PHE and many of those will be extended, at least through 2024.8 As during the pandemic, where the U.S. national payer network (CMS, state Medicaid, and private payers) and state health agencies assisted to ensure patients get the care they need by authorizing providers to be compensated for non–face-to-face services, we believe this service will continue to be part of our clinical practice.
We recommend you stay informed about local and federal laws, regulations, and alternatives for reimbursement as they may be modified at the beginning of a new calendar year. Remember, you can always talk with your revenue cycle team to clarify any query.
Telephone evaluation and management services
The patient requests to speak with you.
Telephone evaluation and management services became more widely used after the pandemic and were recognized by CMS as a covered medical service under PHE. As outlined in Table 1, there are associated codes with this service and it can only apply to an established patient in your practice. The cumulative time spent over a 7-day period without generating an immediate follow-up visit could qualify for this CPT code. However, for a patient with a high-complexity diagnosis and/or decisions being made about care, it might be better to consider a virtual office visit as this would value the complex care at a higher level than the time spent during the telephone E/M encounter.
A common question comes up: Can my nurse or support team bill for telephone care? No, only QHCP can, which means physicians and advanced practice providers can bill for this E/M service, and it does not include time spent by other members of clinical staff in patient care. However, there are CPT codes for chronic care management, which is not covered in this article.
Virtual evaluation and management services
You respond to a patient-initiated portal message.
Patient portal messages increased exponentially during the pandemic with 2.5 more minutes spent per message, resulting in more EHR work by practitioners, compared with prior to the pandemic. One study showed an immediate postpandemic increase in EHR patient-initiated messages with no return to prepandemic baseline.1
Although studies evaluating postpandemic telemedicine services are needed, we believe that this trend will continue, and for this reason, it is important to create sustainable workflows to continue to provide this patient driven avenue of care.9
E-visits are asynchronous patient or guardian portal messages that require a minimum of 5 minutes to provide medical decision-making without prior E/M services in the last 7 days. To obtain reimbursement for this service, it cannot be initiated by the provider, and patient consent must be obtained. Documentation should include this information and the time spent in the encounter. The associated CPT codes with this e-service are outlined in Table 1.
A common question is, “Are there additional codes I should use if a portal message E/M visit lasts more than 30 minutes?” No. If an e-visit lasts more than 30 minutes, the QHCP should bill the CPT code 99423. However, we would advise that, if this care requires more than 30 minutes, then either virtual or face-to-face E/M be considered for the optimal reimbursement for provider time spent. Another common question is around consent for services, and we advise providers to review this requirement with their compliance colleagues as each institution has different policies.
Virtual check-in
Medicare also covers brief communication technology–based services also known as virtual check-ins, where patients can communicate with their provider after having established care. During this brief conversation that can be via telephone, audio/video, secure text messaging, email, or patient portal, providers will determine if an in-person visit is necessary. CMS has designed G codes for these virtual check-ins that are from the Healthcare Common Procedure Coding System (HCPCS). Two codes are available for this E/M service: G2012, which is outlined in Table 1, and G2010, which covers the evaluation of images and/or recorded videos. In order to be reimbursed for a G2010 code, providers need at least a 5-minute response to make a clinical determination or give the patient a medical impression.
Patient satisfaction, physician well-being and quality of care outcomes
Large health care systems like Kaiser Permanente implemented secure message patient-physician communication (the patient portal) even before the pandemic, showing promising results in 2010 with reduction in office visits, improvement in measurable quality outcomes, and high level of patient satisfaction.10 Post pandemic, several large health care centers opted to announce the billing implementation for patient-initiated portal messages.11 A focus was placed on educating their patients about when a message will and will not be billed. Using this type of strategy can help to improve patient awareness about potential billing without affecting patient satisfaction and care outcomes. Studies have shown the EHR has contributed to physician burnout and some physicians reducing their clinical time or leaving medicine; a reduction in messaging might have a positive impact on physician well-being.
The challenge is that medical billing is not routinely included as a curriculum topic in many residency and fellowship programs; however, trainees are part of E/M services and have limited knowledge of billing processes. Unfortunately, at this time, trainees cannot submit for reimbursement for asynchronous care as described above. We hope that this brief article will help junior gastroenterologists optimize their outpatient billing practices.
Dr. Nieto is an internal medicine chief resident with WellStar Cobb Medical Center, Austell, Ga. Dr. Kinnucan is a gastroenterologist with Mayo Clinic, Jacksonville, Fla. The authors have no conflicts of interest to disclose for this article. The authors certify that no financial and grant support has been received for this article.
References
1. Holmgren AJ et al. J Am Med Inform Assoc. 2021 Dec 9. doi: 10.1093/jamia/ocab268.
2. Bali AS et al. Am J Gastroenterol. 2023 Apr 24. doi: 10.14309/ajg.0000000000002254.
3. AAFP. Family Physician. “Coding Scenario: Coding for Virtual-Digital Visits”
4. Keihanian T. et al. Telehealth Utilization in Gastroenterology Clinics Amid the COVID-19 Pandemic: Impact on Clinical Practice and Gastroenterology Training. Gastroenterology. 2020 Jun 20. doi: 10.1053/j.gastro.2020.06.040.
5. Lewin S et al. J Crohns Colitis. 2020 Oct 21. doi: 10.1093/ecco-jcc/jjaa140.
6. Perisetti A and H Goyal. Dig Dis Sci. 2021 Mar 3. doi: 10.1007/s10620-021-06874-x.
7. Telehealth.HHS.gov. Medicaid and Medicare billing for asynchronous telehealth. Updated: 2022 May 4.
8. Telehealth.HHS.gov. Telehealth policy changes after the COVID-19 public health emergency. Last updated: 2023 Jan 23.
9. Fox B and Sizemore JO. Telehealth: Fad or the future. Epic Health Research Network. 2020 Aug 18.
10. Baer D. Patient-physician e-mail communication: the kaiser permanente experience. J Oncol Pract. 2011 Jul. doi: 10.1200/JOP.2011.000323.
11. Myclevelandclinic.org. MyChart Messaging.
12. Sinsky CA et al. J Gen Intern Med. 2022 Aug 29. doi: 10.1007/s11606-022-07766-0.
The American Gastroenterological Association and other gastrointestinal-specific organizations have excellent resources available to members that focus on optimizing reimbursement in your clinical and endoscopic practice.
During the COVID-19 pandemic and public health emergency (PHE), many previously noncovered services were now covered under rules of the Centers for Medicare & Medicaid Services. During the pandemic, patient portal messages increased by 157%, meaning more work for health care teams, negatively impacting physician satisfaction, and increasing burnout.1 Medical burnout has been associated with increased time spent on electronic health records, with some subspeciality gastroenterology (GI) groups having a high EHR burden, according to a recently published article in the American Journal of Gastroenterology.2
This topic is a timely discussion as several large health systems have implemented processes to bill for non–face-to-face services (termed “asynchronous care”), some of which have not been well received in the lay media. It is important to note that despite these implementations, studies have shown only 1% of all incoming portal messages would meet criteria to be submitted for reimbursement. This impact might be slightly higher in chronic care management practices.
Providers and practices have several options when considering billing for non–face-to-face encounters, which we outline in Table 1.3
The focus of this article will be to review the more common non–face-to-face evaluation and management services, such as telephone E/M (patient phone call) and e-visits (patient portal messages) as these have recently generated the most interest and discussion amongst health care providers.
Telemedicine after COVID-19 pandemic
During the beginning of the pandemic, a web-based survey study found that almost all providers in GI practices implemented some form of telemedicine to continue to provide care for patients, compared to 32% prior to the pandemic.4,5 The high demand and essential requirement for telehealth evaluation facilitated its reimbursement, eliminating the primary barrier to previous use.6
One of the new covered benefits by CMS was asynchronous telehealth care.7 The PHE ended in May 2023, and since then a qualified health care provider (QHCP) does not have the full flexibility to deliver telemedicine services across state lines. The U.S. Department of Health and Human Services has considered some telehealth policy changes after the COVID-19 PHE and many of those will be extended, at least through 2024.8 As during the pandemic, where the U.S. national payer network (CMS, state Medicaid, and private payers) and state health agencies assisted to ensure patients get the care they need by authorizing providers to be compensated for non–face-to-face services, we believe this service will continue to be part of our clinical practice.
We recommend you stay informed about local and federal laws, regulations, and alternatives for reimbursement as they may be modified at the beginning of a new calendar year. Remember, you can always talk with your revenue cycle team to clarify any query.
Telephone evaluation and management services
The patient requests to speak with you.
Telephone evaluation and management services became more widely used after the pandemic and were recognized by CMS as a covered medical service under PHE. As outlined in Table 1, there are associated codes with this service and it can only apply to an established patient in your practice. The cumulative time spent over a 7-day period without generating an immediate follow-up visit could qualify for this CPT code. However, for a patient with a high-complexity diagnosis and/or decisions being made about care, it might be better to consider a virtual office visit as this would value the complex care at a higher level than the time spent during the telephone E/M encounter.
A common question comes up: Can my nurse or support team bill for telephone care? No, only QHCP can, which means physicians and advanced practice providers can bill for this E/M service, and it does not include time spent by other members of clinical staff in patient care. However, there are CPT codes for chronic care management, which is not covered in this article.
Virtual evaluation and management services
You respond to a patient-initiated portal message.
Patient portal messages increased exponentially during the pandemic with 2.5 more minutes spent per message, resulting in more EHR work by practitioners, compared with prior to the pandemic. One study showed an immediate postpandemic increase in EHR patient-initiated messages with no return to prepandemic baseline.1
Although studies evaluating postpandemic telemedicine services are needed, we believe that this trend will continue, and for this reason, it is important to create sustainable workflows to continue to provide this patient driven avenue of care.9
E-visits are asynchronous patient or guardian portal messages that require a minimum of 5 minutes to provide medical decision-making without prior E/M services in the last 7 days. To obtain reimbursement for this service, it cannot be initiated by the provider, and patient consent must be obtained. Documentation should include this information and the time spent in the encounter. The associated CPT codes with this e-service are outlined in Table 1.
A common question is, “Are there additional codes I should use if a portal message E/M visit lasts more than 30 minutes?” No. If an e-visit lasts more than 30 minutes, the QHCP should bill the CPT code 99423. However, we would advise that, if this care requires more than 30 minutes, then either virtual or face-to-face E/M be considered for the optimal reimbursement for provider time spent. Another common question is around consent for services, and we advise providers to review this requirement with their compliance colleagues as each institution has different policies.
Virtual check-in
Medicare also covers brief communication technology–based services also known as virtual check-ins, where patients can communicate with their provider after having established care. During this brief conversation that can be via telephone, audio/video, secure text messaging, email, or patient portal, providers will determine if an in-person visit is necessary. CMS has designed G codes for these virtual check-ins that are from the Healthcare Common Procedure Coding System (HCPCS). Two codes are available for this E/M service: G2012, which is outlined in Table 1, and G2010, which covers the evaluation of images and/or recorded videos. In order to be reimbursed for a G2010 code, providers need at least a 5-minute response to make a clinical determination or give the patient a medical impression.
Patient satisfaction, physician well-being and quality of care outcomes
Large health care systems like Kaiser Permanente implemented secure message patient-physician communication (the patient portal) even before the pandemic, showing promising results in 2010 with reduction in office visits, improvement in measurable quality outcomes, and high level of patient satisfaction.10 Post pandemic, several large health care centers opted to announce the billing implementation for patient-initiated portal messages.11 A focus was placed on educating their patients about when a message will and will not be billed. Using this type of strategy can help to improve patient awareness about potential billing without affecting patient satisfaction and care outcomes. Studies have shown the EHR has contributed to physician burnout and some physicians reducing their clinical time or leaving medicine; a reduction in messaging might have a positive impact on physician well-being.
The challenge is that medical billing is not routinely included as a curriculum topic in many residency and fellowship programs; however, trainees are part of E/M services and have limited knowledge of billing processes. Unfortunately, at this time, trainees cannot submit for reimbursement for asynchronous care as described above. We hope that this brief article will help junior gastroenterologists optimize their outpatient billing practices.
Dr. Nieto is an internal medicine chief resident with WellStar Cobb Medical Center, Austell, Ga. Dr. Kinnucan is a gastroenterologist with Mayo Clinic, Jacksonville, Fla. The authors have no conflicts of interest to disclose for this article. The authors certify that no financial and grant support has been received for this article.
References
1. Holmgren AJ et al. J Am Med Inform Assoc. 2021 Dec 9. doi: 10.1093/jamia/ocab268.
2. Bali AS et al. Am J Gastroenterol. 2023 Apr 24. doi: 10.14309/ajg.0000000000002254.
3. AAFP. Family Physician. “Coding Scenario: Coding for Virtual-Digital Visits”
4. Keihanian T. et al. Telehealth Utilization in Gastroenterology Clinics Amid the COVID-19 Pandemic: Impact on Clinical Practice and Gastroenterology Training. Gastroenterology. 2020 Jun 20. doi: 10.1053/j.gastro.2020.06.040.
5. Lewin S et al. J Crohns Colitis. 2020 Oct 21. doi: 10.1093/ecco-jcc/jjaa140.
6. Perisetti A and H Goyal. Dig Dis Sci. 2021 Mar 3. doi: 10.1007/s10620-021-06874-x.
7. Telehealth.HHS.gov. Medicaid and Medicare billing for asynchronous telehealth. Updated: 2022 May 4.
8. Telehealth.HHS.gov. Telehealth policy changes after the COVID-19 public health emergency. Last updated: 2023 Jan 23.
9. Fox B and Sizemore JO. Telehealth: Fad or the future. Epic Health Research Network. 2020 Aug 18.
10. Baer D. Patient-physician e-mail communication: the kaiser permanente experience. J Oncol Pract. 2011 Jul. doi: 10.1200/JOP.2011.000323.
11. Myclevelandclinic.org. MyChart Messaging.
12. Sinsky CA et al. J Gen Intern Med. 2022 Aug 29. doi: 10.1007/s11606-022-07766-0.
The American Gastroenterological Association and other gastrointestinal-specific organizations have excellent resources available to members that focus on optimizing reimbursement in your clinical and endoscopic practice.
During the COVID-19 pandemic and public health emergency (PHE), many previously noncovered services were now covered under rules of the Centers for Medicare & Medicaid Services. During the pandemic, patient portal messages increased by 157%, meaning more work for health care teams, negatively impacting physician satisfaction, and increasing burnout.1 Medical burnout has been associated with increased time spent on electronic health records, with some subspeciality gastroenterology (GI) groups having a high EHR burden, according to a recently published article in the American Journal of Gastroenterology.2
This topic is a timely discussion as several large health systems have implemented processes to bill for non–face-to-face services (termed “asynchronous care”), some of which have not been well received in the lay media. It is important to note that despite these implementations, studies have shown only 1% of all incoming portal messages would meet criteria to be submitted for reimbursement. This impact might be slightly higher in chronic care management practices.
Providers and practices have several options when considering billing for non–face-to-face encounters, which we outline in Table 1.3
The focus of this article will be to review the more common non–face-to-face evaluation and management services, such as telephone E/M (patient phone call) and e-visits (patient portal messages) as these have recently generated the most interest and discussion amongst health care providers.
Telemedicine after COVID-19 pandemic
During the beginning of the pandemic, a web-based survey study found that almost all providers in GI practices implemented some form of telemedicine to continue to provide care for patients, compared to 32% prior to the pandemic.4,5 The high demand and essential requirement for telehealth evaluation facilitated its reimbursement, eliminating the primary barrier to previous use.6
One of the new covered benefits by CMS was asynchronous telehealth care.7 The PHE ended in May 2023, and since then a qualified health care provider (QHCP) does not have the full flexibility to deliver telemedicine services across state lines. The U.S. Department of Health and Human Services has considered some telehealth policy changes after the COVID-19 PHE and many of those will be extended, at least through 2024.8 As during the pandemic, where the U.S. national payer network (CMS, state Medicaid, and private payers) and state health agencies assisted to ensure patients get the care they need by authorizing providers to be compensated for non–face-to-face services, we believe this service will continue to be part of our clinical practice.
We recommend you stay informed about local and federal laws, regulations, and alternatives for reimbursement as they may be modified at the beginning of a new calendar year. Remember, you can always talk with your revenue cycle team to clarify any query.
Telephone evaluation and management services
The patient requests to speak with you.
Telephone evaluation and management services became more widely used after the pandemic and were recognized by CMS as a covered medical service under PHE. As outlined in Table 1, there are associated codes with this service and it can only apply to an established patient in your practice. The cumulative time spent over a 7-day period without generating an immediate follow-up visit could qualify for this CPT code. However, for a patient with a high-complexity diagnosis and/or decisions being made about care, it might be better to consider a virtual office visit as this would value the complex care at a higher level than the time spent during the telephone E/M encounter.
A common question comes up: Can my nurse or support team bill for telephone care? No, only QHCP can, which means physicians and advanced practice providers can bill for this E/M service, and it does not include time spent by other members of clinical staff in patient care. However, there are CPT codes for chronic care management, which is not covered in this article.
Virtual evaluation and management services
You respond to a patient-initiated portal message.
Patient portal messages increased exponentially during the pandemic with 2.5 more minutes spent per message, resulting in more EHR work by practitioners, compared with prior to the pandemic. One study showed an immediate postpandemic increase in EHR patient-initiated messages with no return to prepandemic baseline.1
Although studies evaluating postpandemic telemedicine services are needed, we believe that this trend will continue, and for this reason, it is important to create sustainable workflows to continue to provide this patient driven avenue of care.9
E-visits are asynchronous patient or guardian portal messages that require a minimum of 5 minutes to provide medical decision-making without prior E/M services in the last 7 days. To obtain reimbursement for this service, it cannot be initiated by the provider, and patient consent must be obtained. Documentation should include this information and the time spent in the encounter. The associated CPT codes with this e-service are outlined in Table 1.
A common question is, “Are there additional codes I should use if a portal message E/M visit lasts more than 30 minutes?” No. If an e-visit lasts more than 30 minutes, the QHCP should bill the CPT code 99423. However, we would advise that, if this care requires more than 30 minutes, then either virtual or face-to-face E/M be considered for the optimal reimbursement for provider time spent. Another common question is around consent for services, and we advise providers to review this requirement with their compliance colleagues as each institution has different policies.
Virtual check-in
Medicare also covers brief communication technology–based services also known as virtual check-ins, where patients can communicate with their provider after having established care. During this brief conversation that can be via telephone, audio/video, secure text messaging, email, or patient portal, providers will determine if an in-person visit is necessary. CMS has designed G codes for these virtual check-ins that are from the Healthcare Common Procedure Coding System (HCPCS). Two codes are available for this E/M service: G2012, which is outlined in Table 1, and G2010, which covers the evaluation of images and/or recorded videos. In order to be reimbursed for a G2010 code, providers need at least a 5-minute response to make a clinical determination or give the patient a medical impression.
Patient satisfaction, physician well-being and quality of care outcomes
Large health care systems like Kaiser Permanente implemented secure message patient-physician communication (the patient portal) even before the pandemic, showing promising results in 2010 with reduction in office visits, improvement in measurable quality outcomes, and high level of patient satisfaction.10 Post pandemic, several large health care centers opted to announce the billing implementation for patient-initiated portal messages.11 A focus was placed on educating their patients about when a message will and will not be billed. Using this type of strategy can help to improve patient awareness about potential billing without affecting patient satisfaction and care outcomes. Studies have shown the EHR has contributed to physician burnout and some physicians reducing their clinical time or leaving medicine; a reduction in messaging might have a positive impact on physician well-being.
The challenge is that medical billing is not routinely included as a curriculum topic in many residency and fellowship programs; however, trainees are part of E/M services and have limited knowledge of billing processes. Unfortunately, at this time, trainees cannot submit for reimbursement for asynchronous care as described above. We hope that this brief article will help junior gastroenterologists optimize their outpatient billing practices.
Dr. Nieto is an internal medicine chief resident with WellStar Cobb Medical Center, Austell, Ga. Dr. Kinnucan is a gastroenterologist with Mayo Clinic, Jacksonville, Fla. The authors have no conflicts of interest to disclose for this article. The authors certify that no financial and grant support has been received for this article.
References
1. Holmgren AJ et al. J Am Med Inform Assoc. 2021 Dec 9. doi: 10.1093/jamia/ocab268.
2. Bali AS et al. Am J Gastroenterol. 2023 Apr 24. doi: 10.14309/ajg.0000000000002254.
3. AAFP. Family Physician. “Coding Scenario: Coding for Virtual-Digital Visits”
4. Keihanian T. et al. Telehealth Utilization in Gastroenterology Clinics Amid the COVID-19 Pandemic: Impact on Clinical Practice and Gastroenterology Training. Gastroenterology. 2020 Jun 20. doi: 10.1053/j.gastro.2020.06.040.
5. Lewin S et al. J Crohns Colitis. 2020 Oct 21. doi: 10.1093/ecco-jcc/jjaa140.
6. Perisetti A and H Goyal. Dig Dis Sci. 2021 Mar 3. doi: 10.1007/s10620-021-06874-x.
7. Telehealth.HHS.gov. Medicaid and Medicare billing for asynchronous telehealth. Updated: 2022 May 4.
8. Telehealth.HHS.gov. Telehealth policy changes after the COVID-19 public health emergency. Last updated: 2023 Jan 23.
9. Fox B and Sizemore JO. Telehealth: Fad or the future. Epic Health Research Network. 2020 Aug 18.
10. Baer D. Patient-physician e-mail communication: the kaiser permanente experience. J Oncol Pract. 2011 Jul. doi: 10.1200/JOP.2011.000323.
11. Myclevelandclinic.org. MyChart Messaging.
12. Sinsky CA et al. J Gen Intern Med. 2022 Aug 29. doi: 10.1007/s11606-022-07766-0.
Applications of ChatGPT and Large Language Models in Medicine and Health Care: Benefits and Pitfalls
The development of [artificial intelligence] is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other.
Bill Gates 1
As the world emerges from the pandemic and the health care system faces new challenges, technology has become an increasingly important tool for health care professionals (HCPs). One such technology is the large language model (LLM), which has the potential to revolutionize the health care industry. ChatGPT, a popular LLM developed by OpenAI, has gained particular attention in the medical community for its ability to pass the United States Medical Licensing Exam.2 This article will explore the benefits and potential pitfalls of using LLMs like ChatGPT in medicine and health care.
Benefits
HCP burnout is a serious issue that can lead to lower productivity, increased medical errors, and decreased patient satisfaction.3 LLMs can alleviate some administrative burdens on HCPs, allowing them to focus on patient care. By assisting with billing, coding, insurance claims, and organizing schedules, LLMs like ChatGPT can free up time for HCPs to focus on what they do best: providing quality patient care.4 ChatGPT also can assist with diagnoses by providing accurate and reliable information based on a vast amount of clinical data. By learning the relationships between different medical conditions, symptoms, and treatment options, ChatGPT can provide an appropriate differential diagnosis (Figure 1).
Imaging medical specialists like radiologists, pathologists, dermatologists, and others can benefit from combining computer vision diagnostics with ChatGPT report creation abilities to streamline the diagnostic workflow and improve diagnostic accuracy (Figure 2).
Although using ChatGPT and other LLMs in mental health care has potential benefits, it is essential to note that they are not a substitute for human interaction and personalized care. While ChatGPT can remember information from previous conversations, it cannot provide the same level of personalized, high-quality care that a professional therapist or HCP can. However, by augmenting the work of HCPs, ChatGPT and other LLMs have the potential to make mental health care more accessible and efficient. In addition to providing effective screening in underserved areas, ChatGPT technology may improve the competence of physician assistants and nurse practitioners in delivering mental health care. With the increased incidence of mental health problems in veterans, the pertinence of a ChatGPT-like feature will only increase with time.9
ChatGPT can also be integrated into health care organizations’ websites and mobile apps, providing patients instant access to medical information, self-care advice, symptom checkers, scheduling appointments, and arranging transportation. These features can reduce the burden on health care staff and help patients stay informed and motivated to take an active role in their health. Additionally, health care organizations can use ChatGPT to engage patients by providing reminders for medication renewals and assistance with self-care.4,6,10,11
The potential of artificial intelligence (AI) in the field of medical education and research is immense. According to a study by Gilson and colleagues, ChatGPT has shown promising results as a medical education tool.12 ChatGPT can simulate clinical scenarios, provide real-time feedback, and improve diagnostic skills. It also offers new interactive and personalized learning opportunities for medical students and HCPs.13 ChatGPT can help researchers by streamlining the process of data analysis. It can also administer surveys or questionnaires, facilitate data collection on preferences and experiences, and help in writing scientific publications.14 Nevertheless, to fully unlock the potential of these AI models, additional models that perform checks for factual accuracy, plagiarism, and copyright infringement must be developed.15,16
AI Bill of Rights
In order to protect the American public, the White House Office of Science and Technology Policy (OSTP) has released a blueprint for an AI Bill of Rights that emphasizes 5 principles to protect the public from the harmful effects of AI models, including safe and effective systems; algorithmic discrimination protection; data privacy; notice and explanation; and human alternatives, considerations, and fallback (Figure 3).17
One of the biggest challenges with LLMs like ChatGPT is the prevalence of inaccurate information or so-called hallucinations.16 These inaccuracies stem from the inability of LLMs to distinguish between real and fake information. To prevent hallucinations, researchers have proposed several methods, including training models on more diverse data, using adversarial training methods, and human-in-the-loop approaches.21 In addition, medicine-specific models like GatorTron, medPaLM, and Almanac were developed, increasing the accuracy of factual results.22-24 Unfortunately, only the GatorTron model is available to the public through the NVIDIA developers’ program.25
Despite these shortcomings, the future of LLMs in health care is promising. Although these models will not replace HCPs, they can help reduce the unnecessary burden on them, prevent burnout, and enable HCPs and patients spend more time together. Establishing an official hospital AI oversight governing body that would promote best practices could ensure the trustworthy implementation of these new technologies.26
Conclusions
The use of ChatGPT and other LLMs in health care has the potential to revolutionize the industry. By assisting HCPs with administrative tasks, improving the accuracy and reliability of diagnoses, and engaging patients, ChatGPT can help health care organizations provide better care to their patients. While LLMs are not a substitute for human interaction and personalized care, they can augment the work of HCPs, making health care more accessible and efficient. As the health care industry continues to evolve, it will be exciting to see how ChatGPT and other LLMs are used to improve patient outcomes and quality of care. In addition, AI technologies like ChatGPT offer enormous potential in medical education and research. To ensure that the benefits outweigh the risks, developing trustworthy AI health care products and establishing oversight governing bodies to ensure their implementation is essential. By doing so, we can help HCPs focus on what matters most, providing high-quality care to patients.
Acknowledgments
This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.
1. Bill Gates. The age of AI has begun. March 21, 2023. Accessed May 10, 2023. https://www.gatesnotes.com/the-age-of-ai-has-begun
2. Kung TH, Cheatham M, Medenilla A, et al. Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models. PLOS Digit Health. 2023;2(2):e0000198. Published 2023 Feb 9. doi:10.1371/journal.pdig.0000198
3. Shanafelt TD, West CP, Sinsky C, et al. Changes in burnout and satisfaction with work-life integration in physicians and the general US working population between 2011 and 2020. Mayo Clin Proc. 2022;97(3):491-506. doi:10.1016/j.mayocp.2021.11.021
4. Goodman RS, Patrinely JR Jr, Osterman T, Wheless L, Johnson DB. On the cusp: considering the impact of artificial intelligence language models in healthcare. Med. 2023;4(3):139-140. doi:10.1016/j.medj.2023.02.008
5. Will ChatGPT transform healthcare? Nat Med. 2023;29(3):505-506. doi:10.1038/s41591-023-02289-5
6. Hopkins AM, Logan JM, Kichenadasse G, Sorich MJ. Artificial intelligence chatbots will revolutionize how cancer patients access information: ChatGPT represents a paradigm-shift. JNCI Cancer Spectr. 2023;7(2):pkad010. doi:10.1093/jncics/pkad010
7. Babar Z, van Laarhoven T, Zanzotto FM, Marchiori E. Evaluating diagnostic content of AI-generated radiology reports of chest X-rays. Artif Intell Med. 2021;116:102075. doi:10.1016/j.artmed.2021.102075
8. Lecler A, Duron L, Soyer P. Revolutionizing radiology with GPT-based models: current applications, future possibilities and limitations of ChatGPT. Diagn Interv Imaging. 2023;S2211-5684(23)00027-X. doi:10.1016/j.diii.2023.02.003
9. Germain JM. Is ChatGPT smart enough to practice mental health therapy? March 23, 2023. Accessed May 11, 2023. https://www.technewsworld.com/story/is-chatgpt-smart-enough-to-practice-mental-health-therapy-178064.html
10. Cascella M, Montomoli J, Bellini V, Bignami E. Evaluating the feasibility of ChatGPT in healthcare: an analysis of multiple clinical and research scenarios. J Med Syst. 2023;47(1):33. Published 2023 Mar 4. doi:10.1007/s10916-023-01925-4
11. Jungwirth D, Haluza D. Artificial intelligence and public health: an exploratory study. Int J Environ Res Public Health. 2023;20(5):4541. Published 2023 Mar 3. doi:10.3390/ijerph20054541
12. Gilson A, Safranek CW, Huang T, et al. How does ChatGPT perform on the United States Medical Licensing Examination? The implications of large language models for medical education and knowledge assessment. JMIR Med Educ. 2023;9:e45312. Published 2023 Feb 8. doi:10.2196/45312
13. Eysenbach G. The role of ChatGPT, generative language models, and artificial intelligence in medical education: a conversation with ChatGPT and a call for papers. JMIR Med Educ. 2023;9:e46885. Published 2023 Mar 6. doi:10.2196/46885
14. Macdonald C, Adeloye D, Sheikh A, Rudan I. Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis. J Glob Health. 2023;13:01003. Published 2023 Feb 17. doi:10.7189/jogh.13.01003
15. Masters K. Ethical use of artificial intelligence in health professions education: AMEE Guide No.158. Med Teach. 2023;1-11. doi:10.1080/0142159X.2023.2186203
16. Smith CS. Hallucinations could blunt ChatGPT’s success. IEEE Spectrum. March 13, 2023. Accessed May 11, 2023. https://spectrum.ieee.org/ai-hallucination
17. Executive Office of the President, Office of Science and Technology Policy. Blueprint for an AI Bill of Rights. Accessed May 11, 2023. https://www.whitehouse.gov/ostp/ai-bill-of-rights
18. Executive office of the President. Executive Order 13960: promoting the use of trustworthy artificial intelligence in the federal government. Fed Regist. 2020;89(236):78939-78943.
19. US Department of Commerce, National institute of Standards and Technology. Artificial Intelligence Risk Management Framework (AI RMF 1.0). Published January 2023. doi:10.6028/NIST.AI.100-1
20. Microsoft. Azure Cognitive Search—Cloud Search Service. Accessed May 11, 2023. https://azure.microsoft.com/en-us/products/search
21. Aiyappa R, An J, Kwak H, Ahn YY. Can we trust the evaluation on ChatGPT? March 22, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.12767v1
22. Yang X, Chen A, Pournejatian N, et al. GatorTron: a large clinical language model to unlock patient information from unstructured electronic health records. Updated December 16, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2203.03540v3
23. Singhal K, Azizi S, Tu T, et al. Large language models encode clinical knowledge. December 26, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2212.13138v1
24. Zakka C, Chaurasia A, Shad R, Hiesinger W. Almanac: knowledge-grounded language models for clinical medicine. March 1, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.01229v1
25. NVIDIA. GatorTron-OG. Accessed May 11, 2023. https://catalog.ngc.nvidia.com/orgs/nvidia/teams/clara/models/gatortron_og
26. Borkowski AA, Jakey CE, Thomas LB, Viswanadhan N, Mastorides SM. Establishing a hospital artificial intelligence committee to improve patient care. Fed Pract. 2022;39(8):334-336. doi:10.12788/fp.0299
The development of [artificial intelligence] is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other.
Bill Gates 1
As the world emerges from the pandemic and the health care system faces new challenges, technology has become an increasingly important tool for health care professionals (HCPs). One such technology is the large language model (LLM), which has the potential to revolutionize the health care industry. ChatGPT, a popular LLM developed by OpenAI, has gained particular attention in the medical community for its ability to pass the United States Medical Licensing Exam.2 This article will explore the benefits and potential pitfalls of using LLMs like ChatGPT in medicine and health care.
Benefits
HCP burnout is a serious issue that can lead to lower productivity, increased medical errors, and decreased patient satisfaction.3 LLMs can alleviate some administrative burdens on HCPs, allowing them to focus on patient care. By assisting with billing, coding, insurance claims, and organizing schedules, LLMs like ChatGPT can free up time for HCPs to focus on what they do best: providing quality patient care.4 ChatGPT also can assist with diagnoses by providing accurate and reliable information based on a vast amount of clinical data. By learning the relationships between different medical conditions, symptoms, and treatment options, ChatGPT can provide an appropriate differential diagnosis (Figure 1).
Imaging medical specialists like radiologists, pathologists, dermatologists, and others can benefit from combining computer vision diagnostics with ChatGPT report creation abilities to streamline the diagnostic workflow and improve diagnostic accuracy (Figure 2).
Although using ChatGPT and other LLMs in mental health care has potential benefits, it is essential to note that they are not a substitute for human interaction and personalized care. While ChatGPT can remember information from previous conversations, it cannot provide the same level of personalized, high-quality care that a professional therapist or HCP can. However, by augmenting the work of HCPs, ChatGPT and other LLMs have the potential to make mental health care more accessible and efficient. In addition to providing effective screening in underserved areas, ChatGPT technology may improve the competence of physician assistants and nurse practitioners in delivering mental health care. With the increased incidence of mental health problems in veterans, the pertinence of a ChatGPT-like feature will only increase with time.9
ChatGPT can also be integrated into health care organizations’ websites and mobile apps, providing patients instant access to medical information, self-care advice, symptom checkers, scheduling appointments, and arranging transportation. These features can reduce the burden on health care staff and help patients stay informed and motivated to take an active role in their health. Additionally, health care organizations can use ChatGPT to engage patients by providing reminders for medication renewals and assistance with self-care.4,6,10,11
The potential of artificial intelligence (AI) in the field of medical education and research is immense. According to a study by Gilson and colleagues, ChatGPT has shown promising results as a medical education tool.12 ChatGPT can simulate clinical scenarios, provide real-time feedback, and improve diagnostic skills. It also offers new interactive and personalized learning opportunities for medical students and HCPs.13 ChatGPT can help researchers by streamlining the process of data analysis. It can also administer surveys or questionnaires, facilitate data collection on preferences and experiences, and help in writing scientific publications.14 Nevertheless, to fully unlock the potential of these AI models, additional models that perform checks for factual accuracy, plagiarism, and copyright infringement must be developed.15,16
AI Bill of Rights
In order to protect the American public, the White House Office of Science and Technology Policy (OSTP) has released a blueprint for an AI Bill of Rights that emphasizes 5 principles to protect the public from the harmful effects of AI models, including safe and effective systems; algorithmic discrimination protection; data privacy; notice and explanation; and human alternatives, considerations, and fallback (Figure 3).17
One of the biggest challenges with LLMs like ChatGPT is the prevalence of inaccurate information or so-called hallucinations.16 These inaccuracies stem from the inability of LLMs to distinguish between real and fake information. To prevent hallucinations, researchers have proposed several methods, including training models on more diverse data, using adversarial training methods, and human-in-the-loop approaches.21 In addition, medicine-specific models like GatorTron, medPaLM, and Almanac were developed, increasing the accuracy of factual results.22-24 Unfortunately, only the GatorTron model is available to the public through the NVIDIA developers’ program.25
Despite these shortcomings, the future of LLMs in health care is promising. Although these models will not replace HCPs, they can help reduce the unnecessary burden on them, prevent burnout, and enable HCPs and patients spend more time together. Establishing an official hospital AI oversight governing body that would promote best practices could ensure the trustworthy implementation of these new technologies.26
Conclusions
The use of ChatGPT and other LLMs in health care has the potential to revolutionize the industry. By assisting HCPs with administrative tasks, improving the accuracy and reliability of diagnoses, and engaging patients, ChatGPT can help health care organizations provide better care to their patients. While LLMs are not a substitute for human interaction and personalized care, they can augment the work of HCPs, making health care more accessible and efficient. As the health care industry continues to evolve, it will be exciting to see how ChatGPT and other LLMs are used to improve patient outcomes and quality of care. In addition, AI technologies like ChatGPT offer enormous potential in medical education and research. To ensure that the benefits outweigh the risks, developing trustworthy AI health care products and establishing oversight governing bodies to ensure their implementation is essential. By doing so, we can help HCPs focus on what matters most, providing high-quality care to patients.
Acknowledgments
This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.
The development of [artificial intelligence] is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other.
Bill Gates 1
As the world emerges from the pandemic and the health care system faces new challenges, technology has become an increasingly important tool for health care professionals (HCPs). One such technology is the large language model (LLM), which has the potential to revolutionize the health care industry. ChatGPT, a popular LLM developed by OpenAI, has gained particular attention in the medical community for its ability to pass the United States Medical Licensing Exam.2 This article will explore the benefits and potential pitfalls of using LLMs like ChatGPT in medicine and health care.
Benefits
HCP burnout is a serious issue that can lead to lower productivity, increased medical errors, and decreased patient satisfaction.3 LLMs can alleviate some administrative burdens on HCPs, allowing them to focus on patient care. By assisting with billing, coding, insurance claims, and organizing schedules, LLMs like ChatGPT can free up time for HCPs to focus on what they do best: providing quality patient care.4 ChatGPT also can assist with diagnoses by providing accurate and reliable information based on a vast amount of clinical data. By learning the relationships between different medical conditions, symptoms, and treatment options, ChatGPT can provide an appropriate differential diagnosis (Figure 1).
Imaging medical specialists like radiologists, pathologists, dermatologists, and others can benefit from combining computer vision diagnostics with ChatGPT report creation abilities to streamline the diagnostic workflow and improve diagnostic accuracy (Figure 2).
Although using ChatGPT and other LLMs in mental health care has potential benefits, it is essential to note that they are not a substitute for human interaction and personalized care. While ChatGPT can remember information from previous conversations, it cannot provide the same level of personalized, high-quality care that a professional therapist or HCP can. However, by augmenting the work of HCPs, ChatGPT and other LLMs have the potential to make mental health care more accessible and efficient. In addition to providing effective screening in underserved areas, ChatGPT technology may improve the competence of physician assistants and nurse practitioners in delivering mental health care. With the increased incidence of mental health problems in veterans, the pertinence of a ChatGPT-like feature will only increase with time.9
ChatGPT can also be integrated into health care organizations’ websites and mobile apps, providing patients instant access to medical information, self-care advice, symptom checkers, scheduling appointments, and arranging transportation. These features can reduce the burden on health care staff and help patients stay informed and motivated to take an active role in their health. Additionally, health care organizations can use ChatGPT to engage patients by providing reminders for medication renewals and assistance with self-care.4,6,10,11
The potential of artificial intelligence (AI) in the field of medical education and research is immense. According to a study by Gilson and colleagues, ChatGPT has shown promising results as a medical education tool.12 ChatGPT can simulate clinical scenarios, provide real-time feedback, and improve diagnostic skills. It also offers new interactive and personalized learning opportunities for medical students and HCPs.13 ChatGPT can help researchers by streamlining the process of data analysis. It can also administer surveys or questionnaires, facilitate data collection on preferences and experiences, and help in writing scientific publications.14 Nevertheless, to fully unlock the potential of these AI models, additional models that perform checks for factual accuracy, plagiarism, and copyright infringement must be developed.15,16
AI Bill of Rights
In order to protect the American public, the White House Office of Science and Technology Policy (OSTP) has released a blueprint for an AI Bill of Rights that emphasizes 5 principles to protect the public from the harmful effects of AI models, including safe and effective systems; algorithmic discrimination protection; data privacy; notice and explanation; and human alternatives, considerations, and fallback (Figure 3).17
One of the biggest challenges with LLMs like ChatGPT is the prevalence of inaccurate information or so-called hallucinations.16 These inaccuracies stem from the inability of LLMs to distinguish between real and fake information. To prevent hallucinations, researchers have proposed several methods, including training models on more diverse data, using adversarial training methods, and human-in-the-loop approaches.21 In addition, medicine-specific models like GatorTron, medPaLM, and Almanac were developed, increasing the accuracy of factual results.22-24 Unfortunately, only the GatorTron model is available to the public through the NVIDIA developers’ program.25
Despite these shortcomings, the future of LLMs in health care is promising. Although these models will not replace HCPs, they can help reduce the unnecessary burden on them, prevent burnout, and enable HCPs and patients spend more time together. Establishing an official hospital AI oversight governing body that would promote best practices could ensure the trustworthy implementation of these new technologies.26
Conclusions
The use of ChatGPT and other LLMs in health care has the potential to revolutionize the industry. By assisting HCPs with administrative tasks, improving the accuracy and reliability of diagnoses, and engaging patients, ChatGPT can help health care organizations provide better care to their patients. While LLMs are not a substitute for human interaction and personalized care, they can augment the work of HCPs, making health care more accessible and efficient. As the health care industry continues to evolve, it will be exciting to see how ChatGPT and other LLMs are used to improve patient outcomes and quality of care. In addition, AI technologies like ChatGPT offer enormous potential in medical education and research. To ensure that the benefits outweigh the risks, developing trustworthy AI health care products and establishing oversight governing bodies to ensure their implementation is essential. By doing so, we can help HCPs focus on what matters most, providing high-quality care to patients.
Acknowledgments
This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.
1. Bill Gates. The age of AI has begun. March 21, 2023. Accessed May 10, 2023. https://www.gatesnotes.com/the-age-of-ai-has-begun
2. Kung TH, Cheatham M, Medenilla A, et al. Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models. PLOS Digit Health. 2023;2(2):e0000198. Published 2023 Feb 9. doi:10.1371/journal.pdig.0000198
3. Shanafelt TD, West CP, Sinsky C, et al. Changes in burnout and satisfaction with work-life integration in physicians and the general US working population between 2011 and 2020. Mayo Clin Proc. 2022;97(3):491-506. doi:10.1016/j.mayocp.2021.11.021
4. Goodman RS, Patrinely JR Jr, Osterman T, Wheless L, Johnson DB. On the cusp: considering the impact of artificial intelligence language models in healthcare. Med. 2023;4(3):139-140. doi:10.1016/j.medj.2023.02.008
5. Will ChatGPT transform healthcare? Nat Med. 2023;29(3):505-506. doi:10.1038/s41591-023-02289-5
6. Hopkins AM, Logan JM, Kichenadasse G, Sorich MJ. Artificial intelligence chatbots will revolutionize how cancer patients access information: ChatGPT represents a paradigm-shift. JNCI Cancer Spectr. 2023;7(2):pkad010. doi:10.1093/jncics/pkad010
7. Babar Z, van Laarhoven T, Zanzotto FM, Marchiori E. Evaluating diagnostic content of AI-generated radiology reports of chest X-rays. Artif Intell Med. 2021;116:102075. doi:10.1016/j.artmed.2021.102075
8. Lecler A, Duron L, Soyer P. Revolutionizing radiology with GPT-based models: current applications, future possibilities and limitations of ChatGPT. Diagn Interv Imaging. 2023;S2211-5684(23)00027-X. doi:10.1016/j.diii.2023.02.003
9. Germain JM. Is ChatGPT smart enough to practice mental health therapy? March 23, 2023. Accessed May 11, 2023. https://www.technewsworld.com/story/is-chatgpt-smart-enough-to-practice-mental-health-therapy-178064.html
10. Cascella M, Montomoli J, Bellini V, Bignami E. Evaluating the feasibility of ChatGPT in healthcare: an analysis of multiple clinical and research scenarios. J Med Syst. 2023;47(1):33. Published 2023 Mar 4. doi:10.1007/s10916-023-01925-4
11. Jungwirth D, Haluza D. Artificial intelligence and public health: an exploratory study. Int J Environ Res Public Health. 2023;20(5):4541. Published 2023 Mar 3. doi:10.3390/ijerph20054541
12. Gilson A, Safranek CW, Huang T, et al. How does ChatGPT perform on the United States Medical Licensing Examination? The implications of large language models for medical education and knowledge assessment. JMIR Med Educ. 2023;9:e45312. Published 2023 Feb 8. doi:10.2196/45312
13. Eysenbach G. The role of ChatGPT, generative language models, and artificial intelligence in medical education: a conversation with ChatGPT and a call for papers. JMIR Med Educ. 2023;9:e46885. Published 2023 Mar 6. doi:10.2196/46885
14. Macdonald C, Adeloye D, Sheikh A, Rudan I. Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis. J Glob Health. 2023;13:01003. Published 2023 Feb 17. doi:10.7189/jogh.13.01003
15. Masters K. Ethical use of artificial intelligence in health professions education: AMEE Guide No.158. Med Teach. 2023;1-11. doi:10.1080/0142159X.2023.2186203
16. Smith CS. Hallucinations could blunt ChatGPT’s success. IEEE Spectrum. March 13, 2023. Accessed May 11, 2023. https://spectrum.ieee.org/ai-hallucination
17. Executive Office of the President, Office of Science and Technology Policy. Blueprint for an AI Bill of Rights. Accessed May 11, 2023. https://www.whitehouse.gov/ostp/ai-bill-of-rights
18. Executive office of the President. Executive Order 13960: promoting the use of trustworthy artificial intelligence in the federal government. Fed Regist. 2020;89(236):78939-78943.
19. US Department of Commerce, National institute of Standards and Technology. Artificial Intelligence Risk Management Framework (AI RMF 1.0). Published January 2023. doi:10.6028/NIST.AI.100-1
20. Microsoft. Azure Cognitive Search—Cloud Search Service. Accessed May 11, 2023. https://azure.microsoft.com/en-us/products/search
21. Aiyappa R, An J, Kwak H, Ahn YY. Can we trust the evaluation on ChatGPT? March 22, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.12767v1
22. Yang X, Chen A, Pournejatian N, et al. GatorTron: a large clinical language model to unlock patient information from unstructured electronic health records. Updated December 16, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2203.03540v3
23. Singhal K, Azizi S, Tu T, et al. Large language models encode clinical knowledge. December 26, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2212.13138v1
24. Zakka C, Chaurasia A, Shad R, Hiesinger W. Almanac: knowledge-grounded language models for clinical medicine. March 1, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.01229v1
25. NVIDIA. GatorTron-OG. Accessed May 11, 2023. https://catalog.ngc.nvidia.com/orgs/nvidia/teams/clara/models/gatortron_og
26. Borkowski AA, Jakey CE, Thomas LB, Viswanadhan N, Mastorides SM. Establishing a hospital artificial intelligence committee to improve patient care. Fed Pract. 2022;39(8):334-336. doi:10.12788/fp.0299
1. Bill Gates. The age of AI has begun. March 21, 2023. Accessed May 10, 2023. https://www.gatesnotes.com/the-age-of-ai-has-begun
2. Kung TH, Cheatham M, Medenilla A, et al. Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models. PLOS Digit Health. 2023;2(2):e0000198. Published 2023 Feb 9. doi:10.1371/journal.pdig.0000198
3. Shanafelt TD, West CP, Sinsky C, et al. Changes in burnout and satisfaction with work-life integration in physicians and the general US working population between 2011 and 2020. Mayo Clin Proc. 2022;97(3):491-506. doi:10.1016/j.mayocp.2021.11.021
4. Goodman RS, Patrinely JR Jr, Osterman T, Wheless L, Johnson DB. On the cusp: considering the impact of artificial intelligence language models in healthcare. Med. 2023;4(3):139-140. doi:10.1016/j.medj.2023.02.008
5. Will ChatGPT transform healthcare? Nat Med. 2023;29(3):505-506. doi:10.1038/s41591-023-02289-5
6. Hopkins AM, Logan JM, Kichenadasse G, Sorich MJ. Artificial intelligence chatbots will revolutionize how cancer patients access information: ChatGPT represents a paradigm-shift. JNCI Cancer Spectr. 2023;7(2):pkad010. doi:10.1093/jncics/pkad010
7. Babar Z, van Laarhoven T, Zanzotto FM, Marchiori E. Evaluating diagnostic content of AI-generated radiology reports of chest X-rays. Artif Intell Med. 2021;116:102075. doi:10.1016/j.artmed.2021.102075
8. Lecler A, Duron L, Soyer P. Revolutionizing radiology with GPT-based models: current applications, future possibilities and limitations of ChatGPT. Diagn Interv Imaging. 2023;S2211-5684(23)00027-X. doi:10.1016/j.diii.2023.02.003
9. Germain JM. Is ChatGPT smart enough to practice mental health therapy? March 23, 2023. Accessed May 11, 2023. https://www.technewsworld.com/story/is-chatgpt-smart-enough-to-practice-mental-health-therapy-178064.html
10. Cascella M, Montomoli J, Bellini V, Bignami E. Evaluating the feasibility of ChatGPT in healthcare: an analysis of multiple clinical and research scenarios. J Med Syst. 2023;47(1):33. Published 2023 Mar 4. doi:10.1007/s10916-023-01925-4
11. Jungwirth D, Haluza D. Artificial intelligence and public health: an exploratory study. Int J Environ Res Public Health. 2023;20(5):4541. Published 2023 Mar 3. doi:10.3390/ijerph20054541
12. Gilson A, Safranek CW, Huang T, et al. How does ChatGPT perform on the United States Medical Licensing Examination? The implications of large language models for medical education and knowledge assessment. JMIR Med Educ. 2023;9:e45312. Published 2023 Feb 8. doi:10.2196/45312
13. Eysenbach G. The role of ChatGPT, generative language models, and artificial intelligence in medical education: a conversation with ChatGPT and a call for papers. JMIR Med Educ. 2023;9:e46885. Published 2023 Mar 6. doi:10.2196/46885
14. Macdonald C, Adeloye D, Sheikh A, Rudan I. Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis. J Glob Health. 2023;13:01003. Published 2023 Feb 17. doi:10.7189/jogh.13.01003
15. Masters K. Ethical use of artificial intelligence in health professions education: AMEE Guide No.158. Med Teach. 2023;1-11. doi:10.1080/0142159X.2023.2186203
16. Smith CS. Hallucinations could blunt ChatGPT’s success. IEEE Spectrum. March 13, 2023. Accessed May 11, 2023. https://spectrum.ieee.org/ai-hallucination
17. Executive Office of the President, Office of Science and Technology Policy. Blueprint for an AI Bill of Rights. Accessed May 11, 2023. https://www.whitehouse.gov/ostp/ai-bill-of-rights
18. Executive office of the President. Executive Order 13960: promoting the use of trustworthy artificial intelligence in the federal government. Fed Regist. 2020;89(236):78939-78943.
19. US Department of Commerce, National institute of Standards and Technology. Artificial Intelligence Risk Management Framework (AI RMF 1.0). Published January 2023. doi:10.6028/NIST.AI.100-1
20. Microsoft. Azure Cognitive Search—Cloud Search Service. Accessed May 11, 2023. https://azure.microsoft.com/en-us/products/search
21. Aiyappa R, An J, Kwak H, Ahn YY. Can we trust the evaluation on ChatGPT? March 22, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.12767v1
22. Yang X, Chen A, Pournejatian N, et al. GatorTron: a large clinical language model to unlock patient information from unstructured electronic health records. Updated December 16, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2203.03540v3
23. Singhal K, Azizi S, Tu T, et al. Large language models encode clinical knowledge. December 26, 2022. Accessed May 11, 2023. https://arxiv.org/abs/2212.13138v1
24. Zakka C, Chaurasia A, Shad R, Hiesinger W. Almanac: knowledge-grounded language models for clinical medicine. March 1, 2023. Accessed May 11, 2023. https://arxiv.org/abs/2303.01229v1
25. NVIDIA. GatorTron-OG. Accessed May 11, 2023. https://catalog.ngc.nvidia.com/orgs/nvidia/teams/clara/models/gatortron_og
26. Borkowski AA, Jakey CE, Thomas LB, Viswanadhan N, Mastorides SM. Establishing a hospital artificial intelligence committee to improve patient care. Fed Pract. 2022;39(8):334-336. doi:10.12788/fp.0299
WHO advises against nonsugar sweeteners for weight control
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
Impact of Pharmacist Interventions at an Outpatient US Coast Guard Clinic
The US Coast Guard (USCG) operates within the US Department of Homeland Security during times of peace and represents a force of > 55,000 active-duty service members (ADSMs), civilians, and reservists. ADSMs account for about 40,000 USCG personnel. The missions of the USCG include activities such as maritime law enforcement (drug interdiction), search and rescue, and defense readiness.1 Akin to other US Department of Defense (DoD) services, USCG ADSMs are required to maintain medical readiness to maximize operational success.
Whereas the DoD centralizes its health care services at military treatment facilities, USCG health care tends to be dispersed to smaller clinics and sickbays across large geographic areas. The USCG operates 42 clinics of varying sizes and medical capabilities, providing outpatient, dentistry, pharmacy, laboratory, radiology, physical therapy, optometry, and other health care services. Many ADSMs are evaluated by a USCG medical officer in these outpatient clinics, and ADSMs may choose to fill prescriptions at the in-house pharmacy if present at that clinic.
The USCG has 14 field pharmacists. In addition to the standard dispensing role at their respective clinics, USCG pharmacists provide regional oversight of pharmaceutical services for USCG units within their area of responsibility (AOR). Therefore, USCG pharmacists clinically, operationally, and logistically support these regional assets within their AOR while serving the traditional pharmacist role. USCG pharmacists have access to ADSM electronic health records (EHRs) when evaluating prescription orders, similar to other ambulatory care settings.
New recruits and accessions into the USCG are first screened for disqualifying health conditions, and ADSMs are required to maintain medical readiness throughout their careers.2 Therefore, this population tends to be younger and overall healthier compared with the general population. Equally important, medication errors or inappropriate prescribing in the ADSM group could negatively affect their duty status and mission readiness of the USCG in addition to exposing the ADSM to medication-related harms.
Duty status is an important and unique consideration in this population. ADSMs are expected to be deployable worldwide and physically and mentally capable of executing all duties associated with their position. Duty status implications and the perceived ability to stand watch are tied to an ADMS’s specialty, training, and unit role. Duty status is based on various frameworks like the USCG Medical Manual, Aeromedical Policy Letters, and other governing documents.3 Duty status determinations are initiated by privileged USCG medical practitioners and may be executed in consultation with relevant commands and other subject matter experts. An inappropriately dosed antibiotic prescription, for example, can extend the duration that an ADSM would be considered unfit for full duty due to prolonged illness. Accordingly, being on a limited duty status may negatively affect USCG total mission readiness as a whole. USCG pharmacists play a vital role in optimizing ADSMs’ medication therapies to ensure safety and efficacy.
Currently no published literature explores the number of medication interventions or the impact of those interventions made by USCG pharmacists. This study aimed to quantify the number, duty status impact, and replicability of medication interventions made by one pharmacist at the USCG Base Alameda clinic over 6 months.
Methods
As part of a USCG quality improvement study, a pharmacist tracked all medication interventions on a spreadsheet at USCG Base Alameda clinic from July 1, 2021, to December 31, 2021. The study defined a medication intervention as a communication with the prescriber with the intention to change the medication, strength, dose, dosage form, quantity, or instructions. Each intervention was subcategorized as either a drug therapy problem (DTP) or a non-DTP intervention. Interventions were divided into 7 categories.
Each DTP intervention was evaluated in a retrospective chart review by a panel of USCG pharmacists to assess for duty status severity and replicability. For duty status severity, the panel reviewed the intervention after considering patient-specific factors and determined whether the original prescribing (had there not been an intervention) could have reasonably resulted in a change of duty status for the ADSM from a fit for full duty (FFFD) status to a different duty status (eg, fit for limited duty [FFLD]). This duty status review factored in potential impacts across multiple positions and billets, including aviators (pilots) and divers. In addition, the panel, whose members all have prior community pharmacy experience, assessed replicability by determining whether the same intervention could have reasonably been made in the absence of access to the patient EHR, as would be common in a community pharmacy setting.
Interventions without an identified DTP were considered non-DTP interventions. These interventions involved recommendations for a more cost-effective medication or a similar in stock therapeutic option to minimize delay of patient care. The spreadsheet also included the date, medication name, medication class, specific intervention made, outcome, and other descriptive comments.
Results
During the 6-month period, 1751 prescriptions were dispensed at USCG Base Alameda pharmacy with 116 interventions (7%).
Among the DTP interventions, 26 (41%) dealt with an inappropriate dose, 13 (20%) were for medication omission, 7 (11%) for inappropriate dosage form, and 6 (9%) for excess medication (Table 2).
Discussion
This study is novel in examining the impact of a pharmacist’s medication interventions in a USCG ambulatory care practice setting. A PubMed literature search of the phrases “Coast Guard AND pharmacy” or “Coast Guard AND pharmacy AND intervention” yielded no results specific to pharmacy interventions in a USCG setting. However, the 2021 implementation of the enterprise-wide MHS GENESIS EHR may support additional tracking and analysis tools in the future.
Pharmacist interventions have been studied in diverse patient populations and practice settings, and most conclude that pharmacists make meaningful interventions at their respective organizations.4-7 Many of these studies were conducted at open-door health care systems, whereas USCG clinics serve ADSMs nearly exclusively. The ADSM population tends to be younger and healthier due to age requirements and medical accession and retention standards.
It is important to recognize the value of a USCG pharmacist in identifying and rectifying potential medication errors, particularly those that may affect the ability to stand duty for ADSMs. An example intervention includes changing the daily starting dose of citalopram from the ordered 30 mg to the intended 10 mg. Inappropriately prescribed medication regimens may increase the incidence of adverse effects or prolong duration to therapeutic efficacy, which impairs the ability to stand duty. There were 3 circumstances where the prescriber had ordered the medication for an incorrect ADSM that were rectified by the pharmacist. If left unchanged, these errors could negatively affect the ADSM’s overall health, well-being, and duty status.
The acceptance rate for interventions in this study was 96%. The literature suggests a highly variable acceptance rate of pharmacist interventions when examined across various practice settings, health systems, and geographic locations.8-10 This study’s comparatively high rate could be due to the pharmacist-prescriber relationships at USCG clinics. By virtue of colocatation and teamwork initiatives, the pharmacist has the opportunity to develop positive rapport with physicians, physician assistants, and other clinic staff.
Having access to EHRs allowed the pharmacist to make 18 of the DTP interventions. Chart access is not unique to the USCG and is common in other ambulatory care settings. Those 18 interventions, such as reconciling a prescription ordered as fluticasone/salmeterol but recorded in the EHR as “will prescribe montelukast,” were deemed possible because of EHR access. Such interventions could potentially be lost if ADSMs solely received their pharmaceutical care elsewhere.
USCG uses independent duty health services technicians (IDHSs) who practice in settings where a medical officer is not present, such as at smaller sickbays or aboard Coast Guard cutters. In this study, an IDHS had mistakenly created a medication order for the medical officer to sign for bupropion SR, when the ADSM had been taking and was intended to continue taking bupropion XL. This order was signed off by the medical officer, but this oversight was identified and corrected by the pharmacist before dispensing. This indicates that there is a vital educational role that the USCG pharmacist fulfills when working with health care team members within the AOR.
Equally important to consider are the non-DTP interventions. In a military setting, minimizations of delay in care are a high priority. There were 34 instances where the pharmacist made an intervention to recommend a similar therapeutic medication that was in stock to ensure that the ADSM had timely access to the medication without the need for prior authorization. In the context of short-notice, mission-critical deployments that may last for multiple months, recognizing medication shortages or other inventory constraints and recommending therapeutic alternatives ensures that the USCG can maintain a ready posture for missions in addition to providing timely and quality patient care.
Saving about $1700 over 6 months is also important. While this was not explicitly evaluated in the study, prescribers may not be acutely aware of medication pricing. There are often significant price differences between different formulations of the same medication (eg, naproxen delayed-release vs tablets). Because USCG pharmacists are responsible for ordering medications and managing their regional budget within the AOR, they are best poised to make cost-savings recommendations. These interventions suggest that USCG pharmacists must continue to remain actively involved in the patient care team alongside physicians, physician assistants, nurses, and corpsmen. Throughout this setting and in so many others, patients’ health outcomes improve when pharmacists are more engaged in the pharmacotherapy care plan.
Limitations
Currently, the USCG does not publish ADSM demographic or health-related data, making it difficult to evaluate these interventions in the context of age, gender, or type of disease. Accordingly, potential directions for future research include how USCG pharmacists’ interventions are stratified by duty station and initial diagnosis. Such studies may support future models where USCG pharmacists are providing targeted education to prescribers based on disease or medication classes.
This analysis may have limited applicability to other practice settings even within USCG. Most USCG clinics have a limited number of medical officers; indeed, many have only one, and clinics with pharmacies typically have 1 to 5 medical officers aboard. USCG medical officers have a multitude of other duties, which may impact prescribing patterns and pharmacist interventions. Statistical analyses were limited by the dearth of baseline data or comparative literature. Finally, the assessment of DTP interventions’ impact did not use an official measurement tool like the US Department of Veterans Affairs’ Safety Assessment Code matrix.11 Instead, the study used the internal USCG pharmacist panel for the fitness for duty consideration as the main stratification of the DTP interventions’ duty status severity, because maintaining medical readiness is the top priority for a USCG clinic.
Conclusions
The multifaceted role of pharmacists in USCG clinics includes collaborating with the patient care team to make pharmacy interventions that have significant impacts on ADSMs’ wellness and the USCG mission. The ADSMs of this nation deserve quality medical care that translates into mission readiness, and the USCG pharmacy force stands ready to support that goal.
Acknowledgments
The authors acknowledge the contributions of CDR Christopher Janik, US Coast Guard Headquarters, and LCDR Darin Schneider, US Coast Guard D11 Regional Practice Manager, in the drafting of the manuscript.
1. US Coast Guard. Missions. Accessed May 4, 2023. https://www.uscg.mil/About/Missions
2. US Coast Guard. Coast Guard Medical Manual. Updated September 13, 2022. Accessed May 4, 2023. https://media.defense.gov/2022/Sep/14/2003076969/-1/-1/0/CIM_6000_1F.PDF
3. US Coast Guard. USCG Aeromedical Policy Letters. Accessed May 5, 2023. https://www.dcms.uscg.mil/Portals/10/CG-1/cg112/cg1121/docs/pdf/USCG_Aeromedical_Policy_Letters.pdf
4. Bedouch P, Sylvoz N, Charpiat B, et al. Trends in pharmacists’ medication order review in French hospitals from 2006 to 2009: analysis of pharmacists’ interventions from the Act-IP website observatory. J Clin Pharm Ther. 2015;40(1):32-40. doi:10.1111/jcpt.12214
5. Ooi PL, Zainal H, Lean QY, Ming LC, Ibrahim B. Pharmacists’ interventions on electronic prescriptions from various specialty wards in a Malaysian public hospital: a cross-sectional study. Pharmacy (Basel). 2021;9(4):161. Published 2021 Oct 1. doi:10.3390/pharmacy9040161
6. Alomi YA, El-Bahnasawi M, Kamran M, Shaweesh T, Alhaj S, Radwan RA. The clinical outcomes of pharmacist interventions at critical care services of private hospital in Riyadh City, Saudi Arabia. PTB Report. 2019;5(1):16-19. doi:10.5530/ptb.2019.5.4
7. Garin N, Sole N, Lucas B, et al. Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions. Sci Rep. 2021;11(1):883. Published 2021 Jan 13. doi:10.1038/s41598-020-80560-2
8. Zaal RJ, den Haak EW, Andrinopoulou ER, van Gelder T, Vulto AG, van den Bemt PMLA. Physicians’ acceptance of pharmacists’ interventions in daily hospital practice. Int J Clin Pharm. 2020;42(1):141-149. doi:10.1007/s11096-020-00970-0
9. Carson GL, Crosby K, Huxall GR, Brahm NC. Acceptance rates for pharmacist-initiated interventions in long-term care facilities. Inov Pharm. 2013;4(4):Article 135.
10. Bondesson A, Holmdahl L, Midlöv P, Höglund P, Andersson E, Eriksson T. Acceptance and importance of clinical pharmacists’ LIMM-based recommendations. Int J Clin Pharm. 2012;34(2):272-276. doi:10.1007/s11096-012-9609-3
11. US Department of Veterans Affairs. Safety assessment code (SAC) matrix. Updated June 3, 2015. Accessed May 4, 2023. https://www.patientsafety.va.gov/professionals/publications/matrix.asp
The US Coast Guard (USCG) operates within the US Department of Homeland Security during times of peace and represents a force of > 55,000 active-duty service members (ADSMs), civilians, and reservists. ADSMs account for about 40,000 USCG personnel. The missions of the USCG include activities such as maritime law enforcement (drug interdiction), search and rescue, and defense readiness.1 Akin to other US Department of Defense (DoD) services, USCG ADSMs are required to maintain medical readiness to maximize operational success.
Whereas the DoD centralizes its health care services at military treatment facilities, USCG health care tends to be dispersed to smaller clinics and sickbays across large geographic areas. The USCG operates 42 clinics of varying sizes and medical capabilities, providing outpatient, dentistry, pharmacy, laboratory, radiology, physical therapy, optometry, and other health care services. Many ADSMs are evaluated by a USCG medical officer in these outpatient clinics, and ADSMs may choose to fill prescriptions at the in-house pharmacy if present at that clinic.
The USCG has 14 field pharmacists. In addition to the standard dispensing role at their respective clinics, USCG pharmacists provide regional oversight of pharmaceutical services for USCG units within their area of responsibility (AOR). Therefore, USCG pharmacists clinically, operationally, and logistically support these regional assets within their AOR while serving the traditional pharmacist role. USCG pharmacists have access to ADSM electronic health records (EHRs) when evaluating prescription orders, similar to other ambulatory care settings.
New recruits and accessions into the USCG are first screened for disqualifying health conditions, and ADSMs are required to maintain medical readiness throughout their careers.2 Therefore, this population tends to be younger and overall healthier compared with the general population. Equally important, medication errors or inappropriate prescribing in the ADSM group could negatively affect their duty status and mission readiness of the USCG in addition to exposing the ADSM to medication-related harms.
Duty status is an important and unique consideration in this population. ADSMs are expected to be deployable worldwide and physically and mentally capable of executing all duties associated with their position. Duty status implications and the perceived ability to stand watch are tied to an ADMS’s specialty, training, and unit role. Duty status is based on various frameworks like the USCG Medical Manual, Aeromedical Policy Letters, and other governing documents.3 Duty status determinations are initiated by privileged USCG medical practitioners and may be executed in consultation with relevant commands and other subject matter experts. An inappropriately dosed antibiotic prescription, for example, can extend the duration that an ADSM would be considered unfit for full duty due to prolonged illness. Accordingly, being on a limited duty status may negatively affect USCG total mission readiness as a whole. USCG pharmacists play a vital role in optimizing ADSMs’ medication therapies to ensure safety and efficacy.
Currently no published literature explores the number of medication interventions or the impact of those interventions made by USCG pharmacists. This study aimed to quantify the number, duty status impact, and replicability of medication interventions made by one pharmacist at the USCG Base Alameda clinic over 6 months.
Methods
As part of a USCG quality improvement study, a pharmacist tracked all medication interventions on a spreadsheet at USCG Base Alameda clinic from July 1, 2021, to December 31, 2021. The study defined a medication intervention as a communication with the prescriber with the intention to change the medication, strength, dose, dosage form, quantity, or instructions. Each intervention was subcategorized as either a drug therapy problem (DTP) or a non-DTP intervention. Interventions were divided into 7 categories.
Each DTP intervention was evaluated in a retrospective chart review by a panel of USCG pharmacists to assess for duty status severity and replicability. For duty status severity, the panel reviewed the intervention after considering patient-specific factors and determined whether the original prescribing (had there not been an intervention) could have reasonably resulted in a change of duty status for the ADSM from a fit for full duty (FFFD) status to a different duty status (eg, fit for limited duty [FFLD]). This duty status review factored in potential impacts across multiple positions and billets, including aviators (pilots) and divers. In addition, the panel, whose members all have prior community pharmacy experience, assessed replicability by determining whether the same intervention could have reasonably been made in the absence of access to the patient EHR, as would be common in a community pharmacy setting.
Interventions without an identified DTP were considered non-DTP interventions. These interventions involved recommendations for a more cost-effective medication or a similar in stock therapeutic option to minimize delay of patient care. The spreadsheet also included the date, medication name, medication class, specific intervention made, outcome, and other descriptive comments.
Results
During the 6-month period, 1751 prescriptions were dispensed at USCG Base Alameda pharmacy with 116 interventions (7%).
Among the DTP interventions, 26 (41%) dealt with an inappropriate dose, 13 (20%) were for medication omission, 7 (11%) for inappropriate dosage form, and 6 (9%) for excess medication (Table 2).
Discussion
This study is novel in examining the impact of a pharmacist’s medication interventions in a USCG ambulatory care practice setting. A PubMed literature search of the phrases “Coast Guard AND pharmacy” or “Coast Guard AND pharmacy AND intervention” yielded no results specific to pharmacy interventions in a USCG setting. However, the 2021 implementation of the enterprise-wide MHS GENESIS EHR may support additional tracking and analysis tools in the future.
Pharmacist interventions have been studied in diverse patient populations and practice settings, and most conclude that pharmacists make meaningful interventions at their respective organizations.4-7 Many of these studies were conducted at open-door health care systems, whereas USCG clinics serve ADSMs nearly exclusively. The ADSM population tends to be younger and healthier due to age requirements and medical accession and retention standards.
It is important to recognize the value of a USCG pharmacist in identifying and rectifying potential medication errors, particularly those that may affect the ability to stand duty for ADSMs. An example intervention includes changing the daily starting dose of citalopram from the ordered 30 mg to the intended 10 mg. Inappropriately prescribed medication regimens may increase the incidence of adverse effects or prolong duration to therapeutic efficacy, which impairs the ability to stand duty. There were 3 circumstances where the prescriber had ordered the medication for an incorrect ADSM that were rectified by the pharmacist. If left unchanged, these errors could negatively affect the ADSM’s overall health, well-being, and duty status.
The acceptance rate for interventions in this study was 96%. The literature suggests a highly variable acceptance rate of pharmacist interventions when examined across various practice settings, health systems, and geographic locations.8-10 This study’s comparatively high rate could be due to the pharmacist-prescriber relationships at USCG clinics. By virtue of colocatation and teamwork initiatives, the pharmacist has the opportunity to develop positive rapport with physicians, physician assistants, and other clinic staff.
Having access to EHRs allowed the pharmacist to make 18 of the DTP interventions. Chart access is not unique to the USCG and is common in other ambulatory care settings. Those 18 interventions, such as reconciling a prescription ordered as fluticasone/salmeterol but recorded in the EHR as “will prescribe montelukast,” were deemed possible because of EHR access. Such interventions could potentially be lost if ADSMs solely received their pharmaceutical care elsewhere.
USCG uses independent duty health services technicians (IDHSs) who practice in settings where a medical officer is not present, such as at smaller sickbays or aboard Coast Guard cutters. In this study, an IDHS had mistakenly created a medication order for the medical officer to sign for bupropion SR, when the ADSM had been taking and was intended to continue taking bupropion XL. This order was signed off by the medical officer, but this oversight was identified and corrected by the pharmacist before dispensing. This indicates that there is a vital educational role that the USCG pharmacist fulfills when working with health care team members within the AOR.
Equally important to consider are the non-DTP interventions. In a military setting, minimizations of delay in care are a high priority. There were 34 instances where the pharmacist made an intervention to recommend a similar therapeutic medication that was in stock to ensure that the ADSM had timely access to the medication without the need for prior authorization. In the context of short-notice, mission-critical deployments that may last for multiple months, recognizing medication shortages or other inventory constraints and recommending therapeutic alternatives ensures that the USCG can maintain a ready posture for missions in addition to providing timely and quality patient care.
Saving about $1700 over 6 months is also important. While this was not explicitly evaluated in the study, prescribers may not be acutely aware of medication pricing. There are often significant price differences between different formulations of the same medication (eg, naproxen delayed-release vs tablets). Because USCG pharmacists are responsible for ordering medications and managing their regional budget within the AOR, they are best poised to make cost-savings recommendations. These interventions suggest that USCG pharmacists must continue to remain actively involved in the patient care team alongside physicians, physician assistants, nurses, and corpsmen. Throughout this setting and in so many others, patients’ health outcomes improve when pharmacists are more engaged in the pharmacotherapy care plan.
Limitations
Currently, the USCG does not publish ADSM demographic or health-related data, making it difficult to evaluate these interventions in the context of age, gender, or type of disease. Accordingly, potential directions for future research include how USCG pharmacists’ interventions are stratified by duty station and initial diagnosis. Such studies may support future models where USCG pharmacists are providing targeted education to prescribers based on disease or medication classes.
This analysis may have limited applicability to other practice settings even within USCG. Most USCG clinics have a limited number of medical officers; indeed, many have only one, and clinics with pharmacies typically have 1 to 5 medical officers aboard. USCG medical officers have a multitude of other duties, which may impact prescribing patterns and pharmacist interventions. Statistical analyses were limited by the dearth of baseline data or comparative literature. Finally, the assessment of DTP interventions’ impact did not use an official measurement tool like the US Department of Veterans Affairs’ Safety Assessment Code matrix.11 Instead, the study used the internal USCG pharmacist panel for the fitness for duty consideration as the main stratification of the DTP interventions’ duty status severity, because maintaining medical readiness is the top priority for a USCG clinic.
Conclusions
The multifaceted role of pharmacists in USCG clinics includes collaborating with the patient care team to make pharmacy interventions that have significant impacts on ADSMs’ wellness and the USCG mission. The ADSMs of this nation deserve quality medical care that translates into mission readiness, and the USCG pharmacy force stands ready to support that goal.
Acknowledgments
The authors acknowledge the contributions of CDR Christopher Janik, US Coast Guard Headquarters, and LCDR Darin Schneider, US Coast Guard D11 Regional Practice Manager, in the drafting of the manuscript.
The US Coast Guard (USCG) operates within the US Department of Homeland Security during times of peace and represents a force of > 55,000 active-duty service members (ADSMs), civilians, and reservists. ADSMs account for about 40,000 USCG personnel. The missions of the USCG include activities such as maritime law enforcement (drug interdiction), search and rescue, and defense readiness.1 Akin to other US Department of Defense (DoD) services, USCG ADSMs are required to maintain medical readiness to maximize operational success.
Whereas the DoD centralizes its health care services at military treatment facilities, USCG health care tends to be dispersed to smaller clinics and sickbays across large geographic areas. The USCG operates 42 clinics of varying sizes and medical capabilities, providing outpatient, dentistry, pharmacy, laboratory, radiology, physical therapy, optometry, and other health care services. Many ADSMs are evaluated by a USCG medical officer in these outpatient clinics, and ADSMs may choose to fill prescriptions at the in-house pharmacy if present at that clinic.
The USCG has 14 field pharmacists. In addition to the standard dispensing role at their respective clinics, USCG pharmacists provide regional oversight of pharmaceutical services for USCG units within their area of responsibility (AOR). Therefore, USCG pharmacists clinically, operationally, and logistically support these regional assets within their AOR while serving the traditional pharmacist role. USCG pharmacists have access to ADSM electronic health records (EHRs) when evaluating prescription orders, similar to other ambulatory care settings.
New recruits and accessions into the USCG are first screened for disqualifying health conditions, and ADSMs are required to maintain medical readiness throughout their careers.2 Therefore, this population tends to be younger and overall healthier compared with the general population. Equally important, medication errors or inappropriate prescribing in the ADSM group could negatively affect their duty status and mission readiness of the USCG in addition to exposing the ADSM to medication-related harms.
Duty status is an important and unique consideration in this population. ADSMs are expected to be deployable worldwide and physically and mentally capable of executing all duties associated with their position. Duty status implications and the perceived ability to stand watch are tied to an ADMS’s specialty, training, and unit role. Duty status is based on various frameworks like the USCG Medical Manual, Aeromedical Policy Letters, and other governing documents.3 Duty status determinations are initiated by privileged USCG medical practitioners and may be executed in consultation with relevant commands and other subject matter experts. An inappropriately dosed antibiotic prescription, for example, can extend the duration that an ADSM would be considered unfit for full duty due to prolonged illness. Accordingly, being on a limited duty status may negatively affect USCG total mission readiness as a whole. USCG pharmacists play a vital role in optimizing ADSMs’ medication therapies to ensure safety and efficacy.
Currently no published literature explores the number of medication interventions or the impact of those interventions made by USCG pharmacists. This study aimed to quantify the number, duty status impact, and replicability of medication interventions made by one pharmacist at the USCG Base Alameda clinic over 6 months.
Methods
As part of a USCG quality improvement study, a pharmacist tracked all medication interventions on a spreadsheet at USCG Base Alameda clinic from July 1, 2021, to December 31, 2021. The study defined a medication intervention as a communication with the prescriber with the intention to change the medication, strength, dose, dosage form, quantity, or instructions. Each intervention was subcategorized as either a drug therapy problem (DTP) or a non-DTP intervention. Interventions were divided into 7 categories.
Each DTP intervention was evaluated in a retrospective chart review by a panel of USCG pharmacists to assess for duty status severity and replicability. For duty status severity, the panel reviewed the intervention after considering patient-specific factors and determined whether the original prescribing (had there not been an intervention) could have reasonably resulted in a change of duty status for the ADSM from a fit for full duty (FFFD) status to a different duty status (eg, fit for limited duty [FFLD]). This duty status review factored in potential impacts across multiple positions and billets, including aviators (pilots) and divers. In addition, the panel, whose members all have prior community pharmacy experience, assessed replicability by determining whether the same intervention could have reasonably been made in the absence of access to the patient EHR, as would be common in a community pharmacy setting.
Interventions without an identified DTP were considered non-DTP interventions. These interventions involved recommendations for a more cost-effective medication or a similar in stock therapeutic option to minimize delay of patient care. The spreadsheet also included the date, medication name, medication class, specific intervention made, outcome, and other descriptive comments.
Results
During the 6-month period, 1751 prescriptions were dispensed at USCG Base Alameda pharmacy with 116 interventions (7%).
Among the DTP interventions, 26 (41%) dealt with an inappropriate dose, 13 (20%) were for medication omission, 7 (11%) for inappropriate dosage form, and 6 (9%) for excess medication (Table 2).
Discussion
This study is novel in examining the impact of a pharmacist’s medication interventions in a USCG ambulatory care practice setting. A PubMed literature search of the phrases “Coast Guard AND pharmacy” or “Coast Guard AND pharmacy AND intervention” yielded no results specific to pharmacy interventions in a USCG setting. However, the 2021 implementation of the enterprise-wide MHS GENESIS EHR may support additional tracking and analysis tools in the future.
Pharmacist interventions have been studied in diverse patient populations and practice settings, and most conclude that pharmacists make meaningful interventions at their respective organizations.4-7 Many of these studies were conducted at open-door health care systems, whereas USCG clinics serve ADSMs nearly exclusively. The ADSM population tends to be younger and healthier due to age requirements and medical accession and retention standards.
It is important to recognize the value of a USCG pharmacist in identifying and rectifying potential medication errors, particularly those that may affect the ability to stand duty for ADSMs. An example intervention includes changing the daily starting dose of citalopram from the ordered 30 mg to the intended 10 mg. Inappropriately prescribed medication regimens may increase the incidence of adverse effects or prolong duration to therapeutic efficacy, which impairs the ability to stand duty. There were 3 circumstances where the prescriber had ordered the medication for an incorrect ADSM that were rectified by the pharmacist. If left unchanged, these errors could negatively affect the ADSM’s overall health, well-being, and duty status.
The acceptance rate for interventions in this study was 96%. The literature suggests a highly variable acceptance rate of pharmacist interventions when examined across various practice settings, health systems, and geographic locations.8-10 This study’s comparatively high rate could be due to the pharmacist-prescriber relationships at USCG clinics. By virtue of colocatation and teamwork initiatives, the pharmacist has the opportunity to develop positive rapport with physicians, physician assistants, and other clinic staff.
Having access to EHRs allowed the pharmacist to make 18 of the DTP interventions. Chart access is not unique to the USCG and is common in other ambulatory care settings. Those 18 interventions, such as reconciling a prescription ordered as fluticasone/salmeterol but recorded in the EHR as “will prescribe montelukast,” were deemed possible because of EHR access. Such interventions could potentially be lost if ADSMs solely received their pharmaceutical care elsewhere.
USCG uses independent duty health services technicians (IDHSs) who practice in settings where a medical officer is not present, such as at smaller sickbays or aboard Coast Guard cutters. In this study, an IDHS had mistakenly created a medication order for the medical officer to sign for bupropion SR, when the ADSM had been taking and was intended to continue taking bupropion XL. This order was signed off by the medical officer, but this oversight was identified and corrected by the pharmacist before dispensing. This indicates that there is a vital educational role that the USCG pharmacist fulfills when working with health care team members within the AOR.
Equally important to consider are the non-DTP interventions. In a military setting, minimizations of delay in care are a high priority. There were 34 instances where the pharmacist made an intervention to recommend a similar therapeutic medication that was in stock to ensure that the ADSM had timely access to the medication without the need for prior authorization. In the context of short-notice, mission-critical deployments that may last for multiple months, recognizing medication shortages or other inventory constraints and recommending therapeutic alternatives ensures that the USCG can maintain a ready posture for missions in addition to providing timely and quality patient care.
Saving about $1700 over 6 months is also important. While this was not explicitly evaluated in the study, prescribers may not be acutely aware of medication pricing. There are often significant price differences between different formulations of the same medication (eg, naproxen delayed-release vs tablets). Because USCG pharmacists are responsible for ordering medications and managing their regional budget within the AOR, they are best poised to make cost-savings recommendations. These interventions suggest that USCG pharmacists must continue to remain actively involved in the patient care team alongside physicians, physician assistants, nurses, and corpsmen. Throughout this setting and in so many others, patients’ health outcomes improve when pharmacists are more engaged in the pharmacotherapy care plan.
Limitations
Currently, the USCG does not publish ADSM demographic or health-related data, making it difficult to evaluate these interventions in the context of age, gender, or type of disease. Accordingly, potential directions for future research include how USCG pharmacists’ interventions are stratified by duty station and initial diagnosis. Such studies may support future models where USCG pharmacists are providing targeted education to prescribers based on disease or medication classes.
This analysis may have limited applicability to other practice settings even within USCG. Most USCG clinics have a limited number of medical officers; indeed, many have only one, and clinics with pharmacies typically have 1 to 5 medical officers aboard. USCG medical officers have a multitude of other duties, which may impact prescribing patterns and pharmacist interventions. Statistical analyses were limited by the dearth of baseline data or comparative literature. Finally, the assessment of DTP interventions’ impact did not use an official measurement tool like the US Department of Veterans Affairs’ Safety Assessment Code matrix.11 Instead, the study used the internal USCG pharmacist panel for the fitness for duty consideration as the main stratification of the DTP interventions’ duty status severity, because maintaining medical readiness is the top priority for a USCG clinic.
Conclusions
The multifaceted role of pharmacists in USCG clinics includes collaborating with the patient care team to make pharmacy interventions that have significant impacts on ADSMs’ wellness and the USCG mission. The ADSMs of this nation deserve quality medical care that translates into mission readiness, and the USCG pharmacy force stands ready to support that goal.
Acknowledgments
The authors acknowledge the contributions of CDR Christopher Janik, US Coast Guard Headquarters, and LCDR Darin Schneider, US Coast Guard D11 Regional Practice Manager, in the drafting of the manuscript.
1. US Coast Guard. Missions. Accessed May 4, 2023. https://www.uscg.mil/About/Missions
2. US Coast Guard. Coast Guard Medical Manual. Updated September 13, 2022. Accessed May 4, 2023. https://media.defense.gov/2022/Sep/14/2003076969/-1/-1/0/CIM_6000_1F.PDF
3. US Coast Guard. USCG Aeromedical Policy Letters. Accessed May 5, 2023. https://www.dcms.uscg.mil/Portals/10/CG-1/cg112/cg1121/docs/pdf/USCG_Aeromedical_Policy_Letters.pdf
4. Bedouch P, Sylvoz N, Charpiat B, et al. Trends in pharmacists’ medication order review in French hospitals from 2006 to 2009: analysis of pharmacists’ interventions from the Act-IP website observatory. J Clin Pharm Ther. 2015;40(1):32-40. doi:10.1111/jcpt.12214
5. Ooi PL, Zainal H, Lean QY, Ming LC, Ibrahim B. Pharmacists’ interventions on electronic prescriptions from various specialty wards in a Malaysian public hospital: a cross-sectional study. Pharmacy (Basel). 2021;9(4):161. Published 2021 Oct 1. doi:10.3390/pharmacy9040161
6. Alomi YA, El-Bahnasawi M, Kamran M, Shaweesh T, Alhaj S, Radwan RA. The clinical outcomes of pharmacist interventions at critical care services of private hospital in Riyadh City, Saudi Arabia. PTB Report. 2019;5(1):16-19. doi:10.5530/ptb.2019.5.4
7. Garin N, Sole N, Lucas B, et al. Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions. Sci Rep. 2021;11(1):883. Published 2021 Jan 13. doi:10.1038/s41598-020-80560-2
8. Zaal RJ, den Haak EW, Andrinopoulou ER, van Gelder T, Vulto AG, van den Bemt PMLA. Physicians’ acceptance of pharmacists’ interventions in daily hospital practice. Int J Clin Pharm. 2020;42(1):141-149. doi:10.1007/s11096-020-00970-0
9. Carson GL, Crosby K, Huxall GR, Brahm NC. Acceptance rates for pharmacist-initiated interventions in long-term care facilities. Inov Pharm. 2013;4(4):Article 135.
10. Bondesson A, Holmdahl L, Midlöv P, Höglund P, Andersson E, Eriksson T. Acceptance and importance of clinical pharmacists’ LIMM-based recommendations. Int J Clin Pharm. 2012;34(2):272-276. doi:10.1007/s11096-012-9609-3
11. US Department of Veterans Affairs. Safety assessment code (SAC) matrix. Updated June 3, 2015. Accessed May 4, 2023. https://www.patientsafety.va.gov/professionals/publications/matrix.asp
1. US Coast Guard. Missions. Accessed May 4, 2023. https://www.uscg.mil/About/Missions
2. US Coast Guard. Coast Guard Medical Manual. Updated September 13, 2022. Accessed May 4, 2023. https://media.defense.gov/2022/Sep/14/2003076969/-1/-1/0/CIM_6000_1F.PDF
3. US Coast Guard. USCG Aeromedical Policy Letters. Accessed May 5, 2023. https://www.dcms.uscg.mil/Portals/10/CG-1/cg112/cg1121/docs/pdf/USCG_Aeromedical_Policy_Letters.pdf
4. Bedouch P, Sylvoz N, Charpiat B, et al. Trends in pharmacists’ medication order review in French hospitals from 2006 to 2009: analysis of pharmacists’ interventions from the Act-IP website observatory. J Clin Pharm Ther. 2015;40(1):32-40. doi:10.1111/jcpt.12214
5. Ooi PL, Zainal H, Lean QY, Ming LC, Ibrahim B. Pharmacists’ interventions on electronic prescriptions from various specialty wards in a Malaysian public hospital: a cross-sectional study. Pharmacy (Basel). 2021;9(4):161. Published 2021 Oct 1. doi:10.3390/pharmacy9040161
6. Alomi YA, El-Bahnasawi M, Kamran M, Shaweesh T, Alhaj S, Radwan RA. The clinical outcomes of pharmacist interventions at critical care services of private hospital in Riyadh City, Saudi Arabia. PTB Report. 2019;5(1):16-19. doi:10.5530/ptb.2019.5.4
7. Garin N, Sole N, Lucas B, et al. Drug related problems in clinical practice: a cross-sectional study on their prevalence, risk factors and associated pharmaceutical interventions. Sci Rep. 2021;11(1):883. Published 2021 Jan 13. doi:10.1038/s41598-020-80560-2
8. Zaal RJ, den Haak EW, Andrinopoulou ER, van Gelder T, Vulto AG, van den Bemt PMLA. Physicians’ acceptance of pharmacists’ interventions in daily hospital practice. Int J Clin Pharm. 2020;42(1):141-149. doi:10.1007/s11096-020-00970-0
9. Carson GL, Crosby K, Huxall GR, Brahm NC. Acceptance rates for pharmacist-initiated interventions in long-term care facilities. Inov Pharm. 2013;4(4):Article 135.
10. Bondesson A, Holmdahl L, Midlöv P, Höglund P, Andersson E, Eriksson T. Acceptance and importance of clinical pharmacists’ LIMM-based recommendations. Int J Clin Pharm. 2012;34(2):272-276. doi:10.1007/s11096-012-9609-3
11. US Department of Veterans Affairs. Safety assessment code (SAC) matrix. Updated June 3, 2015. Accessed May 4, 2023. https://www.patientsafety.va.gov/professionals/publications/matrix.asp
Widespread carboplatin, cisplatin shortages: NCCN survey
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
After backlash, publisher to retract article that surveyed parents of children with gender dysphoria, says coauthor
The move is “due to concerns about lack of informed consent,” according to tweets by one of the paper’s authors.
The article, “Rapid Onset Gender Dysphoria: Parent Reports on 1655 Possible Cases,” was published in March in the Archives of Sexual Behavior. It has not been cited in the scientific literature, according to Clarivate’s Web of Science, but Altmetric, which tracks the online attention papers receive, ranks the article in the top 1% of all articles of a similar age.
Rapid Onset Gender Dysphoria (ROGD) is, the article stated, a “controversial theory” that “common cultural beliefs, values, and preoccupations cause some adolescents (especially female adolescents) to attribute their social problems, feelings, and mental health issues to gender dysphoria,” and that “youth with ROGD falsely believe that they are transgender,” in part due to social influences.
Michael Bailey, a psychology professor at Northwestern University in Evanston, Ill., and the paper’s corresponding author, tweeted:
Bailey told Retraction Watch that he would “respond when [he] can” to our request for comment, following “new developments on our end.” Neither Springer Nature nor Kenneth Zucker, editor in chief of Archives of Sexual Behavior, has responded to similar requests.
The paper reported the results of a survey of parents who contacted the website ParentsofROGDKids.com, with which the first author is affiliated. According to the abstract, the authors found:
“Pre-existing mental health issues were common, and youths with these issues were more likely than those without them to have socially and medically transitioned. Parents reported that they had often felt pressured by clinicians to affirm their AYA [adolescent and young adult] child’s new gender and support their transition. According to the parents, AYA children’s mental health deteriorated considerably after social transition.”
Soon after publication, the paper attracted criticism that its method of gathering study participants was biased, and that the authors ignored information that didn’t support the theory of ROGD.
Archives of Sexual Behavior is the official publication of the International Academy of Sex Research, which tweeted on April 19:
The episode prompted a May 5 “Open Letter in Support of Dr. Kenneth Zucker and the Need to Promote Robust Scientific Debate” from the Foundation Against Intolerance and Racism that has now been signed by nearly 2000 people.
On May 10, the following publisher’s note was added to the article:
“readers are alerted that concerns have been raised regarding methodology as described in this article. The publisher is currently investigating this matter and a further response will follow the conclusion of this investigation.
Six days later, the publisher removed the article’s supplementary information “due to a lack of documented consent by study participants.”
The story may feel familiar to readers who recall what happened to another paper in 2018. In that paper, Brown University’s Lisa Littman coined the term ROGD. Following a backlash, Brown took down a press release touting the results, and the paper was eventually republished with corrections.
Bailey has been accused of mistreating transgender research participants, but an investigation by bioethicist Alice Dreger found that of the many accusations, “almost none appear to have been legitimate.”
In a post on UnHerd earlier this month, Bailey responded to the reported concerns about the study lacking approval by an Institutional Review Board (IRB), and that the way the participants were recruited biased the results.
IRB approval was not necessary, Bailey wrote, because Suzanna Diaz, the first author who collected the data, was not affiliated with an institution that required it. “Suzanna Diaz” is a pseudonym for “the mother of a gender dysphoric child she believes has ROGD” who wishes to remain anonymous for the sake of her family, Bailey wrote.
The paper included the following statement about its ethical approval:
“The first author and creator of the survey is not affiliated with any university or hospital. Thus, she did not seek approval from an IRB. After seeing a presentation of preliminary survey results by the first author, the second author suggested the data to be analyzed and submitted as an academic article (he was not involved in collecting the data). The second author consulted with his university’s IRB, who declined to certify the study because data were already collected. However, they advised that publishing the results was likely ethical provided data were deidentified. Editor’s note: After I reviewed the manuscript, I concluded that its publication is ethically appropriate, consistent with Springer policy.”
In his UnHerd post, Bailey quoted from the journal’s submission guidelines:
“If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor’s discretion.”
“Regarding the methodological limitations of the study, these were addressed forthrightly and thoroughly in our article,” Bailey wrote.
Adam Marcus, a cofounder of Retraction Watch, is an editor at this news organization.
A version of this article first appeared on RetractionWatch.com.
The move is “due to concerns about lack of informed consent,” according to tweets by one of the paper’s authors.
The article, “Rapid Onset Gender Dysphoria: Parent Reports on 1655 Possible Cases,” was published in March in the Archives of Sexual Behavior. It has not been cited in the scientific literature, according to Clarivate’s Web of Science, but Altmetric, which tracks the online attention papers receive, ranks the article in the top 1% of all articles of a similar age.
Rapid Onset Gender Dysphoria (ROGD) is, the article stated, a “controversial theory” that “common cultural beliefs, values, and preoccupations cause some adolescents (especially female adolescents) to attribute their social problems, feelings, and mental health issues to gender dysphoria,” and that “youth with ROGD falsely believe that they are transgender,” in part due to social influences.
Michael Bailey, a psychology professor at Northwestern University in Evanston, Ill., and the paper’s corresponding author, tweeted:
Bailey told Retraction Watch that he would “respond when [he] can” to our request for comment, following “new developments on our end.” Neither Springer Nature nor Kenneth Zucker, editor in chief of Archives of Sexual Behavior, has responded to similar requests.
The paper reported the results of a survey of parents who contacted the website ParentsofROGDKids.com, with which the first author is affiliated. According to the abstract, the authors found:
“Pre-existing mental health issues were common, and youths with these issues were more likely than those without them to have socially and medically transitioned. Parents reported that they had often felt pressured by clinicians to affirm their AYA [adolescent and young adult] child’s new gender and support their transition. According to the parents, AYA children’s mental health deteriorated considerably after social transition.”
Soon after publication, the paper attracted criticism that its method of gathering study participants was biased, and that the authors ignored information that didn’t support the theory of ROGD.
Archives of Sexual Behavior is the official publication of the International Academy of Sex Research, which tweeted on April 19:
The episode prompted a May 5 “Open Letter in Support of Dr. Kenneth Zucker and the Need to Promote Robust Scientific Debate” from the Foundation Against Intolerance and Racism that has now been signed by nearly 2000 people.
On May 10, the following publisher’s note was added to the article:
“readers are alerted that concerns have been raised regarding methodology as described in this article. The publisher is currently investigating this matter and a further response will follow the conclusion of this investigation.
Six days later, the publisher removed the article’s supplementary information “due to a lack of documented consent by study participants.”
The story may feel familiar to readers who recall what happened to another paper in 2018. In that paper, Brown University’s Lisa Littman coined the term ROGD. Following a backlash, Brown took down a press release touting the results, and the paper was eventually republished with corrections.
Bailey has been accused of mistreating transgender research participants, but an investigation by bioethicist Alice Dreger found that of the many accusations, “almost none appear to have been legitimate.”
In a post on UnHerd earlier this month, Bailey responded to the reported concerns about the study lacking approval by an Institutional Review Board (IRB), and that the way the participants were recruited biased the results.
IRB approval was not necessary, Bailey wrote, because Suzanna Diaz, the first author who collected the data, was not affiliated with an institution that required it. “Suzanna Diaz” is a pseudonym for “the mother of a gender dysphoric child she believes has ROGD” who wishes to remain anonymous for the sake of her family, Bailey wrote.
The paper included the following statement about its ethical approval:
“The first author and creator of the survey is not affiliated with any university or hospital. Thus, she did not seek approval from an IRB. After seeing a presentation of preliminary survey results by the first author, the second author suggested the data to be analyzed and submitted as an academic article (he was not involved in collecting the data). The second author consulted with his university’s IRB, who declined to certify the study because data were already collected. However, they advised that publishing the results was likely ethical provided data were deidentified. Editor’s note: After I reviewed the manuscript, I concluded that its publication is ethically appropriate, consistent with Springer policy.”
In his UnHerd post, Bailey quoted from the journal’s submission guidelines:
“If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor’s discretion.”
“Regarding the methodological limitations of the study, these were addressed forthrightly and thoroughly in our article,” Bailey wrote.
Adam Marcus, a cofounder of Retraction Watch, is an editor at this news organization.
A version of this article first appeared on RetractionWatch.com.
The move is “due to concerns about lack of informed consent,” according to tweets by one of the paper’s authors.
The article, “Rapid Onset Gender Dysphoria: Parent Reports on 1655 Possible Cases,” was published in March in the Archives of Sexual Behavior. It has not been cited in the scientific literature, according to Clarivate’s Web of Science, but Altmetric, which tracks the online attention papers receive, ranks the article in the top 1% of all articles of a similar age.
Rapid Onset Gender Dysphoria (ROGD) is, the article stated, a “controversial theory” that “common cultural beliefs, values, and preoccupations cause some adolescents (especially female adolescents) to attribute their social problems, feelings, and mental health issues to gender dysphoria,” and that “youth with ROGD falsely believe that they are transgender,” in part due to social influences.
Michael Bailey, a psychology professor at Northwestern University in Evanston, Ill., and the paper’s corresponding author, tweeted:
Bailey told Retraction Watch that he would “respond when [he] can” to our request for comment, following “new developments on our end.” Neither Springer Nature nor Kenneth Zucker, editor in chief of Archives of Sexual Behavior, has responded to similar requests.
The paper reported the results of a survey of parents who contacted the website ParentsofROGDKids.com, with which the first author is affiliated. According to the abstract, the authors found:
“Pre-existing mental health issues were common, and youths with these issues were more likely than those without them to have socially and medically transitioned. Parents reported that they had often felt pressured by clinicians to affirm their AYA [adolescent and young adult] child’s new gender and support their transition. According to the parents, AYA children’s mental health deteriorated considerably after social transition.”
Soon after publication, the paper attracted criticism that its method of gathering study participants was biased, and that the authors ignored information that didn’t support the theory of ROGD.
Archives of Sexual Behavior is the official publication of the International Academy of Sex Research, which tweeted on April 19:
The episode prompted a May 5 “Open Letter in Support of Dr. Kenneth Zucker and the Need to Promote Robust Scientific Debate” from the Foundation Against Intolerance and Racism that has now been signed by nearly 2000 people.
On May 10, the following publisher’s note was added to the article:
“readers are alerted that concerns have been raised regarding methodology as described in this article. The publisher is currently investigating this matter and a further response will follow the conclusion of this investigation.
Six days later, the publisher removed the article’s supplementary information “due to a lack of documented consent by study participants.”
The story may feel familiar to readers who recall what happened to another paper in 2018. In that paper, Brown University’s Lisa Littman coined the term ROGD. Following a backlash, Brown took down a press release touting the results, and the paper was eventually republished with corrections.
Bailey has been accused of mistreating transgender research participants, but an investigation by bioethicist Alice Dreger found that of the many accusations, “almost none appear to have been legitimate.”
In a post on UnHerd earlier this month, Bailey responded to the reported concerns about the study lacking approval by an Institutional Review Board (IRB), and that the way the participants were recruited biased the results.
IRB approval was not necessary, Bailey wrote, because Suzanna Diaz, the first author who collected the data, was not affiliated with an institution that required it. “Suzanna Diaz” is a pseudonym for “the mother of a gender dysphoric child she believes has ROGD” who wishes to remain anonymous for the sake of her family, Bailey wrote.
The paper included the following statement about its ethical approval:
“The first author and creator of the survey is not affiliated with any university or hospital. Thus, she did not seek approval from an IRB. After seeing a presentation of preliminary survey results by the first author, the second author suggested the data to be analyzed and submitted as an academic article (he was not involved in collecting the data). The second author consulted with his university’s IRB, who declined to certify the study because data were already collected. However, they advised that publishing the results was likely ethical provided data were deidentified. Editor’s note: After I reviewed the manuscript, I concluded that its publication is ethically appropriate, consistent with Springer policy.”
In his UnHerd post, Bailey quoted from the journal’s submission guidelines:
“If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor’s discretion.”
“Regarding the methodological limitations of the study, these were addressed forthrightly and thoroughly in our article,” Bailey wrote.
Adam Marcus, a cofounder of Retraction Watch, is an editor at this news organization.
A version of this article first appeared on RetractionWatch.com.
Link between bipolar disorder and CVD mortality explained?
in new findings that may explain the “excessive and premature mortality” related to heart disease in this patient population.
The investigators found that higher reactive hyperemia index (RHI) scores, a measure of endothelial function, were tied to mood severity in patients with higher mania, but not depression scores. These findings persisted even after accounting for medications, obesity, and other cardiovascular risk factors (CVRFs).
“From a clinical perspective, these findings highlight the potential value of integrating vascular health in the assessment and management of youth with BD, and from a scientific perspective, these findings call for additional research focused on shared biological mechanisms linking vascular health and mood symptoms of BD,” senior investigator Benjamin Goldstein, MD, PhD, full professor of psychiatry, pharmacology, and psychological clinical science, University of Toronto, said in an interview.
The study was published online in the Journal of Clinical Psychiatry.
‘Excessively present’
BD is associated with “excessive and premature cardiovascular mortality” and CVD is “excessively present” in BD, exceeding what can be explained by traditional cardiovascular risk factors, psychiatric medications, and substance use, the researchers noted.
“In adults, more severe mood symptoms increase the risk of future CVD. Our focus on endothelial function rose due to the fact that CVD is rare in youth, whereas endothelial dysfunction – considered a precursor of CVD – can be assessed in youth,” said Dr. Goldstein, who holds the RBC Investments Chair in children’s mental health and developmental psychopathology at the Centre for Addiction and Mental Health, Toronto, where he is director of the Centre for Youth Bipolar Disorder.
For this reason, he and his colleagues were “interested in researching whether endothelial dysfunction is associated with mood symptoms in youth with BD.” Ultimately, the motivation was to “inspire new therapeutic opportunities that may improve both cardiovascular and mental health simultaneously.”
To investigate the question, the researchers studied 209 youth aged 13-20 years (n = 114 with BD and 94 healthy controls [HCs]).
In the BD group, there were 34 BD-euthymia, 36 BD-depressed, and 44 BD-hypomanic/mixed; and within the groups who had depression or hypomania/mixed features, 72 were experiencing clinically significant depression.
Participants had to be free of chronic inflammatory illness, use of medications that might be addressing traditional CVRFs, recent infectious diseases, or neurologic conditions.
Participants’ bipolar symptoms, psychosocial functioning, and family history were assessed. In addition, they were asked about treatment, physical and/or sexual abuse, smoking status, and socioeconomic status. Height, weight, waist circumference, blood pressure, and blood tests to assess CVRFs, including C-reactive protein (CRP), were also assessed. RHI was measured via pulse amplitude tonometry, with lower values indicating poorer endothelial function.
Positive affect beneficial?
Compared with HCs, there were fewer White participants in the BD group (78% vs. 55%; P < .001). The BD group also had higher Tanner stage development scores (stage 5: 65% vs. 35%; P = .03; V = 0.21), higher body mass index (BMI, 24.4 ± 4.6 vs. 22.0 ± 4.2; P < .001; d = 0.53), and higher CRP (1.94 ± 3.99 vs. 0.76 ± 0.86; P = .009; d = –0.40).
After controlling for age, sex, and BMI (F3,202 = 4.47; P = .005; np2 = 0.06), the researchers found significant between-group differences in RHI.
Post hoc pairwise comparisons showed RHI to be significantly lower in the BD-depressed versus the HC group (P = .04; d = 0.4). Moreover, the BD-hypomanic/mixed group had significantly higher RHI, compared with the other BD groups and the HC group.
RHI was associated with higher mania scores (beta, 0.26; P = .006), but there was no similar significant association with depression mood scores (beta, 0.01; P = .90).
The mood state differences in RHI and the RHI-mania association remained significant in sensitivity analyses examining the effect of current medication use as well as CVRFs, including lipids, CRP, and blood pressure on RHI.
“We found that youth with BD experiencing a depressive episode had lower endothelial function, whereas youth with BD experiencing a hypomanic/mixed episode had higher endothelial function, as compared to healthy youth,” Dr. Goldstein said.
There are several mechanisms potentially underlying the association between endothelial function and hypomania, the investigators noted. For example, positive affect is associated with increased endothelial function in normative samples, so hypomanic symptoms, including elation, may have similar beneficial associations, although those benefits likely do not extend to mania, which has been associated with cardiovascular risk.
They also point to several limitations in the study. The cross-sectional design “precludes making inferences regarding the temporal relationship between RHI and mood.” Moreover, the study focused only on hypomania, so “we cannot draw conclusions about mania.” In addition, the HC group had a “significantly higher proportion” of White participants, and a lower Tanner stage, so it “may not be a representative control sample.”
Nevertheless, the researchers concluded that the study “adds to the existing evidence for the potential value of integrating cardiovascular-related therapeutic approaches in BD,” noting that further research is needed to elucidate the mechanisms of the association.
Observable changes in youth
In a comment, Jess G Fiedorowicz, MD, PhD, head and chief, department of mental health, Ottawa Hospital Research Institute, noted that individuals with BD “have a much higher risk of CVD, which tends to develop earlier and shortens life expectancy by more than a decade.”
This cardiovascular risk “appears to be acquired over the long-term course of illness and proportionate to the persistence and severity of mood symptoms, which implies that mood syndromes, such as depression and mania, themselves may induce changes in the body relevant to CVD,” said Dr. Fiedorowicz, who is also a professor in the department of psychiatry and senior research chair in adult psychiatry at the Brain and Mind Research Institute, University of Ottawa, and was not involved with the study.
The study “adds to a growing body of evidence that mood syndromes may enact physiological changes that may be relevant to risk of CVD. One important aspect of this study is that this can even be observed in young sample,” he said.
This study was funded by the Canadian Institutes of Health Research and a Miner’s Lamp Innovation Fund from the University of Toronto. Dr. Goldstein and coauthors declare no relevant financial relationships. Dr. Fiedorowicz receives an honorarium from Elsevier for his work as editor-in-chief of the Journal of Psychosomatic Research.
A version of this article first appeared on Medscape.com.
in new findings that may explain the “excessive and premature mortality” related to heart disease in this patient population.
The investigators found that higher reactive hyperemia index (RHI) scores, a measure of endothelial function, were tied to mood severity in patients with higher mania, but not depression scores. These findings persisted even after accounting for medications, obesity, and other cardiovascular risk factors (CVRFs).
“From a clinical perspective, these findings highlight the potential value of integrating vascular health in the assessment and management of youth with BD, and from a scientific perspective, these findings call for additional research focused on shared biological mechanisms linking vascular health and mood symptoms of BD,” senior investigator Benjamin Goldstein, MD, PhD, full professor of psychiatry, pharmacology, and psychological clinical science, University of Toronto, said in an interview.
The study was published online in the Journal of Clinical Psychiatry.
‘Excessively present’
BD is associated with “excessive and premature cardiovascular mortality” and CVD is “excessively present” in BD, exceeding what can be explained by traditional cardiovascular risk factors, psychiatric medications, and substance use, the researchers noted.
“In adults, more severe mood symptoms increase the risk of future CVD. Our focus on endothelial function rose due to the fact that CVD is rare in youth, whereas endothelial dysfunction – considered a precursor of CVD – can be assessed in youth,” said Dr. Goldstein, who holds the RBC Investments Chair in children’s mental health and developmental psychopathology at the Centre for Addiction and Mental Health, Toronto, where he is director of the Centre for Youth Bipolar Disorder.
For this reason, he and his colleagues were “interested in researching whether endothelial dysfunction is associated with mood symptoms in youth with BD.” Ultimately, the motivation was to “inspire new therapeutic opportunities that may improve both cardiovascular and mental health simultaneously.”
To investigate the question, the researchers studied 209 youth aged 13-20 years (n = 114 with BD and 94 healthy controls [HCs]).
In the BD group, there were 34 BD-euthymia, 36 BD-depressed, and 44 BD-hypomanic/mixed; and within the groups who had depression or hypomania/mixed features, 72 were experiencing clinically significant depression.
Participants had to be free of chronic inflammatory illness, use of medications that might be addressing traditional CVRFs, recent infectious diseases, or neurologic conditions.
Participants’ bipolar symptoms, psychosocial functioning, and family history were assessed. In addition, they were asked about treatment, physical and/or sexual abuse, smoking status, and socioeconomic status. Height, weight, waist circumference, blood pressure, and blood tests to assess CVRFs, including C-reactive protein (CRP), were also assessed. RHI was measured via pulse amplitude tonometry, with lower values indicating poorer endothelial function.
Positive affect beneficial?
Compared with HCs, there were fewer White participants in the BD group (78% vs. 55%; P < .001). The BD group also had higher Tanner stage development scores (stage 5: 65% vs. 35%; P = .03; V = 0.21), higher body mass index (BMI, 24.4 ± 4.6 vs. 22.0 ± 4.2; P < .001; d = 0.53), and higher CRP (1.94 ± 3.99 vs. 0.76 ± 0.86; P = .009; d = –0.40).
After controlling for age, sex, and BMI (F3,202 = 4.47; P = .005; np2 = 0.06), the researchers found significant between-group differences in RHI.
Post hoc pairwise comparisons showed RHI to be significantly lower in the BD-depressed versus the HC group (P = .04; d = 0.4). Moreover, the BD-hypomanic/mixed group had significantly higher RHI, compared with the other BD groups and the HC group.
RHI was associated with higher mania scores (beta, 0.26; P = .006), but there was no similar significant association with depression mood scores (beta, 0.01; P = .90).
The mood state differences in RHI and the RHI-mania association remained significant in sensitivity analyses examining the effect of current medication use as well as CVRFs, including lipids, CRP, and blood pressure on RHI.
“We found that youth with BD experiencing a depressive episode had lower endothelial function, whereas youth with BD experiencing a hypomanic/mixed episode had higher endothelial function, as compared to healthy youth,” Dr. Goldstein said.
There are several mechanisms potentially underlying the association between endothelial function and hypomania, the investigators noted. For example, positive affect is associated with increased endothelial function in normative samples, so hypomanic symptoms, including elation, may have similar beneficial associations, although those benefits likely do not extend to mania, which has been associated with cardiovascular risk.
They also point to several limitations in the study. The cross-sectional design “precludes making inferences regarding the temporal relationship between RHI and mood.” Moreover, the study focused only on hypomania, so “we cannot draw conclusions about mania.” In addition, the HC group had a “significantly higher proportion” of White participants, and a lower Tanner stage, so it “may not be a representative control sample.”
Nevertheless, the researchers concluded that the study “adds to the existing evidence for the potential value of integrating cardiovascular-related therapeutic approaches in BD,” noting that further research is needed to elucidate the mechanisms of the association.
Observable changes in youth
In a comment, Jess G Fiedorowicz, MD, PhD, head and chief, department of mental health, Ottawa Hospital Research Institute, noted that individuals with BD “have a much higher risk of CVD, which tends to develop earlier and shortens life expectancy by more than a decade.”
This cardiovascular risk “appears to be acquired over the long-term course of illness and proportionate to the persistence and severity of mood symptoms, which implies that mood syndromes, such as depression and mania, themselves may induce changes in the body relevant to CVD,” said Dr. Fiedorowicz, who is also a professor in the department of psychiatry and senior research chair in adult psychiatry at the Brain and Mind Research Institute, University of Ottawa, and was not involved with the study.
The study “adds to a growing body of evidence that mood syndromes may enact physiological changes that may be relevant to risk of CVD. One important aspect of this study is that this can even be observed in young sample,” he said.
This study was funded by the Canadian Institutes of Health Research and a Miner’s Lamp Innovation Fund from the University of Toronto. Dr. Goldstein and coauthors declare no relevant financial relationships. Dr. Fiedorowicz receives an honorarium from Elsevier for his work as editor-in-chief of the Journal of Psychosomatic Research.
A version of this article first appeared on Medscape.com.
in new findings that may explain the “excessive and premature mortality” related to heart disease in this patient population.
The investigators found that higher reactive hyperemia index (RHI) scores, a measure of endothelial function, were tied to mood severity in patients with higher mania, but not depression scores. These findings persisted even after accounting for medications, obesity, and other cardiovascular risk factors (CVRFs).
“From a clinical perspective, these findings highlight the potential value of integrating vascular health in the assessment and management of youth with BD, and from a scientific perspective, these findings call for additional research focused on shared biological mechanisms linking vascular health and mood symptoms of BD,” senior investigator Benjamin Goldstein, MD, PhD, full professor of psychiatry, pharmacology, and psychological clinical science, University of Toronto, said in an interview.
The study was published online in the Journal of Clinical Psychiatry.
‘Excessively present’
BD is associated with “excessive and premature cardiovascular mortality” and CVD is “excessively present” in BD, exceeding what can be explained by traditional cardiovascular risk factors, psychiatric medications, and substance use, the researchers noted.
“In adults, more severe mood symptoms increase the risk of future CVD. Our focus on endothelial function rose due to the fact that CVD is rare in youth, whereas endothelial dysfunction – considered a precursor of CVD – can be assessed in youth,” said Dr. Goldstein, who holds the RBC Investments Chair in children’s mental health and developmental psychopathology at the Centre for Addiction and Mental Health, Toronto, where he is director of the Centre for Youth Bipolar Disorder.
For this reason, he and his colleagues were “interested in researching whether endothelial dysfunction is associated with mood symptoms in youth with BD.” Ultimately, the motivation was to “inspire new therapeutic opportunities that may improve both cardiovascular and mental health simultaneously.”
To investigate the question, the researchers studied 209 youth aged 13-20 years (n = 114 with BD and 94 healthy controls [HCs]).
In the BD group, there were 34 BD-euthymia, 36 BD-depressed, and 44 BD-hypomanic/mixed; and within the groups who had depression or hypomania/mixed features, 72 were experiencing clinically significant depression.
Participants had to be free of chronic inflammatory illness, use of medications that might be addressing traditional CVRFs, recent infectious diseases, or neurologic conditions.
Participants’ bipolar symptoms, psychosocial functioning, and family history were assessed. In addition, they were asked about treatment, physical and/or sexual abuse, smoking status, and socioeconomic status. Height, weight, waist circumference, blood pressure, and blood tests to assess CVRFs, including C-reactive protein (CRP), were also assessed. RHI was measured via pulse amplitude tonometry, with lower values indicating poorer endothelial function.
Positive affect beneficial?
Compared with HCs, there were fewer White participants in the BD group (78% vs. 55%; P < .001). The BD group also had higher Tanner stage development scores (stage 5: 65% vs. 35%; P = .03; V = 0.21), higher body mass index (BMI, 24.4 ± 4.6 vs. 22.0 ± 4.2; P < .001; d = 0.53), and higher CRP (1.94 ± 3.99 vs. 0.76 ± 0.86; P = .009; d = –0.40).
After controlling for age, sex, and BMI (F3,202 = 4.47; P = .005; np2 = 0.06), the researchers found significant between-group differences in RHI.
Post hoc pairwise comparisons showed RHI to be significantly lower in the BD-depressed versus the HC group (P = .04; d = 0.4). Moreover, the BD-hypomanic/mixed group had significantly higher RHI, compared with the other BD groups and the HC group.
RHI was associated with higher mania scores (beta, 0.26; P = .006), but there was no similar significant association with depression mood scores (beta, 0.01; P = .90).
The mood state differences in RHI and the RHI-mania association remained significant in sensitivity analyses examining the effect of current medication use as well as CVRFs, including lipids, CRP, and blood pressure on RHI.
“We found that youth with BD experiencing a depressive episode had lower endothelial function, whereas youth with BD experiencing a hypomanic/mixed episode had higher endothelial function, as compared to healthy youth,” Dr. Goldstein said.
There are several mechanisms potentially underlying the association between endothelial function and hypomania, the investigators noted. For example, positive affect is associated with increased endothelial function in normative samples, so hypomanic symptoms, including elation, may have similar beneficial associations, although those benefits likely do not extend to mania, which has been associated with cardiovascular risk.
They also point to several limitations in the study. The cross-sectional design “precludes making inferences regarding the temporal relationship between RHI and mood.” Moreover, the study focused only on hypomania, so “we cannot draw conclusions about mania.” In addition, the HC group had a “significantly higher proportion” of White participants, and a lower Tanner stage, so it “may not be a representative control sample.”
Nevertheless, the researchers concluded that the study “adds to the existing evidence for the potential value of integrating cardiovascular-related therapeutic approaches in BD,” noting that further research is needed to elucidate the mechanisms of the association.
Observable changes in youth
In a comment, Jess G Fiedorowicz, MD, PhD, head and chief, department of mental health, Ottawa Hospital Research Institute, noted that individuals with BD “have a much higher risk of CVD, which tends to develop earlier and shortens life expectancy by more than a decade.”
This cardiovascular risk “appears to be acquired over the long-term course of illness and proportionate to the persistence and severity of mood symptoms, which implies that mood syndromes, such as depression and mania, themselves may induce changes in the body relevant to CVD,” said Dr. Fiedorowicz, who is also a professor in the department of psychiatry and senior research chair in adult psychiatry at the Brain and Mind Research Institute, University of Ottawa, and was not involved with the study.
The study “adds to a growing body of evidence that mood syndromes may enact physiological changes that may be relevant to risk of CVD. One important aspect of this study is that this can even be observed in young sample,” he said.
This study was funded by the Canadian Institutes of Health Research and a Miner’s Lamp Innovation Fund from the University of Toronto. Dr. Goldstein and coauthors declare no relevant financial relationships. Dr. Fiedorowicz receives an honorarium from Elsevier for his work as editor-in-chief of the Journal of Psychosomatic Research.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL PSYCHIATRY
Unraveling the mechanisms behind FMT efficacy needed to expand its use
A deeper understanding of the mechanisms underlying the success of fecal microbiota transplantation (FMT) is needed to further improve its effectiveness, according to two recent reviews published in Cell Host and Microbe.
how closely the donor’s microbial composition matches the patient’s existing microbiome, and the presence of nonbacterial gut inhabitants like viruses and fungi – affect FMT success, according to a press release.
FMT is most often used to treat recurrent Clostridioides difficile infections, which don’t always respond to antibiotics. Success rates range from 60% to 90%, depending on the administration route and study design, notes an international research team led by Abbas Yadegar, PhD, a medical bacteriologist at the Shahid Beheshti University of Medical Sciences in Tehran, Iran.
The understanding of how FMT works is incomplete, however, and the reasons some patients fail to benefit is unclear, note Dr. Yadegar and colleagues. Little attention has been paid to the role that other components of the patient’s microbiome, along with outside factors, play in the treatment’s success, they add.
“We wanted other researchers to look beyond changes in stool microbial composition and function, which have been the focus of research in the past few years,” Dr. Yadegar’s team said in a statement provided to this news organization.
Dr. Yadegar and colleagues’ review of more than 130 studies summarizes recent evidence on the mechanisms contributing to FMT success against recurrent C. difficile infection, highlights knowledge gaps, and proposes future research directions in the field.
Factors that influence FMT’s effectiveness and the potential the procedure holds for treatment of other diseases associated with gut dysbiosis are the subject of a review of 149 studies by a team of researchers led by Serena Porcari, MD, a gastroenterologist at the Fondazione Policlinico Universitario Gemelli and Università Cattolica del Sacro Cuore, in Rome.
“Our main goal was not only to unravel the different mechanisms of FMT efficacy but also to introduce some mindset shifts that are needed to bring FMT forward, mainly covering the gap that exists between basic scientists and clinicians,” Gianluca Ianiro, MD, PhD, a senior researcher in digestive diseases who works with Dr. Porcari and is the review’s lead author, told this news organization.
Engraftment may influence success
Engraftment of donor microbial strains in recipients appears to be key to the therapeutic success of FMT, both reviews note.
Three factors influence engraftment: the donor’s bacteria fitness relative to the recipient, the bacteria already present in the recipient, and whether antibiotics are used prior to FMT to open a niche for the incoming donor microbes, according to Dr. Yadegar and colleagues.
How to calculate strain engraftment has not yet been standardized in the field, and the number of strains detected in the recipient’s fecal sample is dependent on the depth of sequencing techniques, Dr. Porcari and colleagues note.
The use of whole-genome sequencing has enabled more precise evaluation of engraftment, they add.
“With this approach, microbial engraftment has been associated with clinical success, regardless of the disease, in a large metagenomic metanalysis of 24 FMT trials and almost 1,400 fecal samples,” Dr. Porcari and colleagues write. However, these results have not been replicated, likely because of differences between the studies.
More study on the topic is needed, both articles note.
“Because the recent metagenomics studies compared pre- and post-FMT only in cases with successful treatment outcomes, it is not possible to link engraftment to clinical outcomes,” Dr. Yadegar and colleagues write in their statement to this news organization.
A closer look at donor-recipient pairings
Clinicians usually enlist healthy, carefully screened individuals as FMT donors.
However, both research groups conclude that fine-scale taxonomic and metabolic analyses of donor and recipient microbiomes would better inform clinical decisions, especially when treating diseases other than C. difficile.
This may call for a more personalized approach to choosing donor-recipient pairings. Investigators should assess the patient’s diet and genetic background and how closely the donor’s microbiome matches that of the patient.
“Most studies focused on profiling stool samples before and after FMT without also including functional analyses; therefore, there are still a lot of aspects of host microbial interactions that remain unknown,” write Dr. Yadegar and colleagues in their statement.
Ecologic factors, including diet and host genetics, are often not included in clinical studies of C. difficile, but they “may potentially be the missing links” to treatment failure in the small portion of patients whose condition doesn’t respond to FMT, they write.
Pairing donor-recipient combinations on the basis of dietary patterns and preferences could improve FMT efficacy because the donor microbiota would be preadapted to the recipient’s diet, Dr. Yadegar and colleagues write. The team is examining how donor and recipient diet may affect outcomes.
Dr. Porcari and colleagues add that while some studies support the existence of shared characteristics that make up super-donors, others found that the optimal donor is more patient specific. They call for personalized selection strategies that employ microbiome sequencing tools rather than a “one stool fits all” approach.
Currently, many clinicians aren’t familiar with microbiome sequencing and analysis, but they’ll need to be in the near future, note Dr. Porcari and colleagues.
“Identifying microbiome characteristics that maximize strain engraftment in the FMT will allow clinicians to select the best donor for each single patient,” they write.
The possible role of viruses and fungi
In FMT research, investigators tend to focus on the bacteria in the human microbiome. However, viruses and fungi also appear to play a role, both articles note.
“Other microbial kingdoms that inhabit the intestine should be taken into account when considering predictors of post-FMT microbial transfer,” write Dr. Porcari and colleagues.
Although few studies have examined the gut virome’s impact on FMT effectiveness against C. difficile, the existing research, although limited, indicates that bacteriophage viruses could play a role, Dr. Yadegar and colleagues note. For example, high levels of donor-derived Caudoviralesbacteriophages in recipients were associated with FMT efficacy in one preliminary study, they write.
In a small human study, fecal filtrate from healthy donors who had bacteriophages but no live bacteria successfully treated five patients with recurrent C. difficile infection, Dr. Yadegar and colleagues write.
“Therefore, the idea that viruses may play a role is very provocative,” write Dr. Yadegar’s team in their statement.
It’s important to note that these studies are associative, which means they can’t definitively answer the question of how or whether viruses play a role, Dr. Yadegar’s team added.
Researchers “know even less about how fungi may or may not play a role,” write Dr. Yadegar and colleagues. However, in early research that involved patients who had successfully undergone FMT for C. difficile, there was higher relative abundance of Saccharomyces and Aspergillus, whereas Candida, if prominent, may impede response, they write in their article.
Additionally, to explore whether live bacteria are necessary for FMT to work, Dr. Yadegar and colleagues informed this news organization that they are conducting a study “comparing traditional FMT to a fecal filtrate that contains no live bacteria, but has all other components, to see if we can achieve similar success rates in recurrent C. difficile infection.”
Repeat treatment for sustained response
Dr. Yadegar’s team offered another important takeaway: A single FMT treatment will not sustain a positive response, especially when treating chronic noncommunicable conditions in which intestinal dysbiosis may play a role. Repeat treatment will be needed, as with other chronic conditions. This has been shown even in C. difficile infection.
“Recent studies have documented a significant advantage of repeated FMT over single FMT on the cure rates of recurrent C. difficile,” especially for patients with inflammatory bowel disorder, Dr. Yadegar’s team told this news organization.
“What we don’t know is which patient is likely to respond to microbial-based therapy, or what the dose or frequency should be, or which bacteria are responsible for the effects,” Dr. Yadegar and team said.
Dr. Porcari and colleagues are examining whether FMT could be refined to improve its success against other diseases. This may involve selecting specific donors, monitoring the gut microbiome of both donors and recipients, or using a specific means of delivery, such as lyophilized capsules, Dr. Ianiro said.
A response to FMT for chronic, noncommunicable disorders typically is not sustained long term, note Dr. Porcari and colleagues. However, they add that “sequential transplants have been applied in this setting with promising results, suggesting that chronic modulation of the patient microbiome may be beneficial in noncommunicable chronic disorders.” Dr. Porcari and colleagues point to the success of repeated, long-term FMT in studies of patients with ulcerative colitis and irritable bowel syndrome.
The use of cutting-edge technologies for microbiome assessment and a change in the view of FMT as only an acute, single-use therapy could improve FMT protocols and outcomes for noncommunicable conditions, they write.
Expanding FMT beyond C. difficile
Dr. Yadegar and colleagues’ article “really breaks down what is known about the mechanisms of FMT in C. difficile infection, which is important as other live biotherapeutic products are developed,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, R.I., who was not involved with the reviews, said in an interview.
Dr. Yadegar and colleagues concur. They note in a press release that as the mechanisms behind FMT success are understood, that information should be used to design new standardized therapies.
“Although highly effective, there are substantial drawbacks with [FMT], including infectious risks and sparse long-term safety data,” they write. “Better treatment options for recurrent C. difficile infections that are targeted, safe, and donor-independent are thus desired.”
In December 2022, the U.S. Food and Drug Administration approved the first fecal microbiota product, Rebyota, to prevent recurrence of C. difficile. More recently, in April 2023, the FDA approved Vowst, a pill for treating recurrent C. difficile infections.
Dr. Kelly also noted that the article by Dr. Yadegar and colleagues “may help us understand why a small percentage of patients fail to achieve cure after FMT.”
Regarding Dr. Porcari and colleagues’ article, Dr. Kelly said, “There is a lot of hope that FMT or other gut microbiome therapies will be beneficial for conditions outside of C. difficile.
“They do a good job reviewing the state of the science of FMT and highlight the many unknowns around the use of FMT in conditions outside of C. difficile,” added Dr. Kelly, who has been using FMT to treat C. difficile for more than 15 years.
Data supporting FMT for conditions such as ulcerative colitis and autism are compelling, Dr. Kelly acknowledged. But in her view, FMT isn’t ready for “prime time” outside of C. difficile – at least not yet.
“Academic investigators and those in industry are actively conducting research in many non–C. difficile indications, and I predict we will see the emergence of gut microbiome–based therapies for other indications within the next 5-10 years,” Dr. Kelly said.
Dr. Yadegar reports no relevant financial relationships. One coauthor of the Yadegar study has served on the adjudication board for Finch Therapeutics and has received consulting fees and a speaking honorarium from Rebiotix/Ferring Pharmaceuticals. Dr. Ianiro reports no relevant financial relationships. Dr. Kelly has consulted for Sebela Pharmaceuticals and is one of the principal investigators for the FMT National Patient Registry funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
A version of this article originally appeared on Medscape.com.
A deeper understanding of the mechanisms underlying the success of fecal microbiota transplantation (FMT) is needed to further improve its effectiveness, according to two recent reviews published in Cell Host and Microbe.
how closely the donor’s microbial composition matches the patient’s existing microbiome, and the presence of nonbacterial gut inhabitants like viruses and fungi – affect FMT success, according to a press release.
FMT is most often used to treat recurrent Clostridioides difficile infections, which don’t always respond to antibiotics. Success rates range from 60% to 90%, depending on the administration route and study design, notes an international research team led by Abbas Yadegar, PhD, a medical bacteriologist at the Shahid Beheshti University of Medical Sciences in Tehran, Iran.
The understanding of how FMT works is incomplete, however, and the reasons some patients fail to benefit is unclear, note Dr. Yadegar and colleagues. Little attention has been paid to the role that other components of the patient’s microbiome, along with outside factors, play in the treatment’s success, they add.
“We wanted other researchers to look beyond changes in stool microbial composition and function, which have been the focus of research in the past few years,” Dr. Yadegar’s team said in a statement provided to this news organization.
Dr. Yadegar and colleagues’ review of more than 130 studies summarizes recent evidence on the mechanisms contributing to FMT success against recurrent C. difficile infection, highlights knowledge gaps, and proposes future research directions in the field.
Factors that influence FMT’s effectiveness and the potential the procedure holds for treatment of other diseases associated with gut dysbiosis are the subject of a review of 149 studies by a team of researchers led by Serena Porcari, MD, a gastroenterologist at the Fondazione Policlinico Universitario Gemelli and Università Cattolica del Sacro Cuore, in Rome.
“Our main goal was not only to unravel the different mechanisms of FMT efficacy but also to introduce some mindset shifts that are needed to bring FMT forward, mainly covering the gap that exists between basic scientists and clinicians,” Gianluca Ianiro, MD, PhD, a senior researcher in digestive diseases who works with Dr. Porcari and is the review’s lead author, told this news organization.
Engraftment may influence success
Engraftment of donor microbial strains in recipients appears to be key to the therapeutic success of FMT, both reviews note.
Three factors influence engraftment: the donor’s bacteria fitness relative to the recipient, the bacteria already present in the recipient, and whether antibiotics are used prior to FMT to open a niche for the incoming donor microbes, according to Dr. Yadegar and colleagues.
How to calculate strain engraftment has not yet been standardized in the field, and the number of strains detected in the recipient’s fecal sample is dependent on the depth of sequencing techniques, Dr. Porcari and colleagues note.
The use of whole-genome sequencing has enabled more precise evaluation of engraftment, they add.
“With this approach, microbial engraftment has been associated with clinical success, regardless of the disease, in a large metagenomic metanalysis of 24 FMT trials and almost 1,400 fecal samples,” Dr. Porcari and colleagues write. However, these results have not been replicated, likely because of differences between the studies.
More study on the topic is needed, both articles note.
“Because the recent metagenomics studies compared pre- and post-FMT only in cases with successful treatment outcomes, it is not possible to link engraftment to clinical outcomes,” Dr. Yadegar and colleagues write in their statement to this news organization.
A closer look at donor-recipient pairings
Clinicians usually enlist healthy, carefully screened individuals as FMT donors.
However, both research groups conclude that fine-scale taxonomic and metabolic analyses of donor and recipient microbiomes would better inform clinical decisions, especially when treating diseases other than C. difficile.
This may call for a more personalized approach to choosing donor-recipient pairings. Investigators should assess the patient’s diet and genetic background and how closely the donor’s microbiome matches that of the patient.
“Most studies focused on profiling stool samples before and after FMT without also including functional analyses; therefore, there are still a lot of aspects of host microbial interactions that remain unknown,” write Dr. Yadegar and colleagues in their statement.
Ecologic factors, including diet and host genetics, are often not included in clinical studies of C. difficile, but they “may potentially be the missing links” to treatment failure in the small portion of patients whose condition doesn’t respond to FMT, they write.
Pairing donor-recipient combinations on the basis of dietary patterns and preferences could improve FMT efficacy because the donor microbiota would be preadapted to the recipient’s diet, Dr. Yadegar and colleagues write. The team is examining how donor and recipient diet may affect outcomes.
Dr. Porcari and colleagues add that while some studies support the existence of shared characteristics that make up super-donors, others found that the optimal donor is more patient specific. They call for personalized selection strategies that employ microbiome sequencing tools rather than a “one stool fits all” approach.
Currently, many clinicians aren’t familiar with microbiome sequencing and analysis, but they’ll need to be in the near future, note Dr. Porcari and colleagues.
“Identifying microbiome characteristics that maximize strain engraftment in the FMT will allow clinicians to select the best donor for each single patient,” they write.
The possible role of viruses and fungi
In FMT research, investigators tend to focus on the bacteria in the human microbiome. However, viruses and fungi also appear to play a role, both articles note.
“Other microbial kingdoms that inhabit the intestine should be taken into account when considering predictors of post-FMT microbial transfer,” write Dr. Porcari and colleagues.
Although few studies have examined the gut virome’s impact on FMT effectiveness against C. difficile, the existing research, although limited, indicates that bacteriophage viruses could play a role, Dr. Yadegar and colleagues note. For example, high levels of donor-derived Caudoviralesbacteriophages in recipients were associated with FMT efficacy in one preliminary study, they write.
In a small human study, fecal filtrate from healthy donors who had bacteriophages but no live bacteria successfully treated five patients with recurrent C. difficile infection, Dr. Yadegar and colleagues write.
“Therefore, the idea that viruses may play a role is very provocative,” write Dr. Yadegar’s team in their statement.
It’s important to note that these studies are associative, which means they can’t definitively answer the question of how or whether viruses play a role, Dr. Yadegar’s team added.
Researchers “know even less about how fungi may or may not play a role,” write Dr. Yadegar and colleagues. However, in early research that involved patients who had successfully undergone FMT for C. difficile, there was higher relative abundance of Saccharomyces and Aspergillus, whereas Candida, if prominent, may impede response, they write in their article.
Additionally, to explore whether live bacteria are necessary for FMT to work, Dr. Yadegar and colleagues informed this news organization that they are conducting a study “comparing traditional FMT to a fecal filtrate that contains no live bacteria, but has all other components, to see if we can achieve similar success rates in recurrent C. difficile infection.”
Repeat treatment for sustained response
Dr. Yadegar’s team offered another important takeaway: A single FMT treatment will not sustain a positive response, especially when treating chronic noncommunicable conditions in which intestinal dysbiosis may play a role. Repeat treatment will be needed, as with other chronic conditions. This has been shown even in C. difficile infection.
“Recent studies have documented a significant advantage of repeated FMT over single FMT on the cure rates of recurrent C. difficile,” especially for patients with inflammatory bowel disorder, Dr. Yadegar’s team told this news organization.
“What we don’t know is which patient is likely to respond to microbial-based therapy, or what the dose or frequency should be, or which bacteria are responsible for the effects,” Dr. Yadegar and team said.
Dr. Porcari and colleagues are examining whether FMT could be refined to improve its success against other diseases. This may involve selecting specific donors, monitoring the gut microbiome of both donors and recipients, or using a specific means of delivery, such as lyophilized capsules, Dr. Ianiro said.
A response to FMT for chronic, noncommunicable disorders typically is not sustained long term, note Dr. Porcari and colleagues. However, they add that “sequential transplants have been applied in this setting with promising results, suggesting that chronic modulation of the patient microbiome may be beneficial in noncommunicable chronic disorders.” Dr. Porcari and colleagues point to the success of repeated, long-term FMT in studies of patients with ulcerative colitis and irritable bowel syndrome.
The use of cutting-edge technologies for microbiome assessment and a change in the view of FMT as only an acute, single-use therapy could improve FMT protocols and outcomes for noncommunicable conditions, they write.
Expanding FMT beyond C. difficile
Dr. Yadegar and colleagues’ article “really breaks down what is known about the mechanisms of FMT in C. difficile infection, which is important as other live biotherapeutic products are developed,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, R.I., who was not involved with the reviews, said in an interview.
Dr. Yadegar and colleagues concur. They note in a press release that as the mechanisms behind FMT success are understood, that information should be used to design new standardized therapies.
“Although highly effective, there are substantial drawbacks with [FMT], including infectious risks and sparse long-term safety data,” they write. “Better treatment options for recurrent C. difficile infections that are targeted, safe, and donor-independent are thus desired.”
In December 2022, the U.S. Food and Drug Administration approved the first fecal microbiota product, Rebyota, to prevent recurrence of C. difficile. More recently, in April 2023, the FDA approved Vowst, a pill for treating recurrent C. difficile infections.
Dr. Kelly also noted that the article by Dr. Yadegar and colleagues “may help us understand why a small percentage of patients fail to achieve cure after FMT.”
Regarding Dr. Porcari and colleagues’ article, Dr. Kelly said, “There is a lot of hope that FMT or other gut microbiome therapies will be beneficial for conditions outside of C. difficile.
“They do a good job reviewing the state of the science of FMT and highlight the many unknowns around the use of FMT in conditions outside of C. difficile,” added Dr. Kelly, who has been using FMT to treat C. difficile for more than 15 years.
Data supporting FMT for conditions such as ulcerative colitis and autism are compelling, Dr. Kelly acknowledged. But in her view, FMT isn’t ready for “prime time” outside of C. difficile – at least not yet.
“Academic investigators and those in industry are actively conducting research in many non–C. difficile indications, and I predict we will see the emergence of gut microbiome–based therapies for other indications within the next 5-10 years,” Dr. Kelly said.
Dr. Yadegar reports no relevant financial relationships. One coauthor of the Yadegar study has served on the adjudication board for Finch Therapeutics and has received consulting fees and a speaking honorarium from Rebiotix/Ferring Pharmaceuticals. Dr. Ianiro reports no relevant financial relationships. Dr. Kelly has consulted for Sebela Pharmaceuticals and is one of the principal investigators for the FMT National Patient Registry funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
A version of this article originally appeared on Medscape.com.
A deeper understanding of the mechanisms underlying the success of fecal microbiota transplantation (FMT) is needed to further improve its effectiveness, according to two recent reviews published in Cell Host and Microbe.
how closely the donor’s microbial composition matches the patient’s existing microbiome, and the presence of nonbacterial gut inhabitants like viruses and fungi – affect FMT success, according to a press release.
FMT is most often used to treat recurrent Clostridioides difficile infections, which don’t always respond to antibiotics. Success rates range from 60% to 90%, depending on the administration route and study design, notes an international research team led by Abbas Yadegar, PhD, a medical bacteriologist at the Shahid Beheshti University of Medical Sciences in Tehran, Iran.
The understanding of how FMT works is incomplete, however, and the reasons some patients fail to benefit is unclear, note Dr. Yadegar and colleagues. Little attention has been paid to the role that other components of the patient’s microbiome, along with outside factors, play in the treatment’s success, they add.
“We wanted other researchers to look beyond changes in stool microbial composition and function, which have been the focus of research in the past few years,” Dr. Yadegar’s team said in a statement provided to this news organization.
Dr. Yadegar and colleagues’ review of more than 130 studies summarizes recent evidence on the mechanisms contributing to FMT success against recurrent C. difficile infection, highlights knowledge gaps, and proposes future research directions in the field.
Factors that influence FMT’s effectiveness and the potential the procedure holds for treatment of other diseases associated with gut dysbiosis are the subject of a review of 149 studies by a team of researchers led by Serena Porcari, MD, a gastroenterologist at the Fondazione Policlinico Universitario Gemelli and Università Cattolica del Sacro Cuore, in Rome.
“Our main goal was not only to unravel the different mechanisms of FMT efficacy but also to introduce some mindset shifts that are needed to bring FMT forward, mainly covering the gap that exists between basic scientists and clinicians,” Gianluca Ianiro, MD, PhD, a senior researcher in digestive diseases who works with Dr. Porcari and is the review’s lead author, told this news organization.
Engraftment may influence success
Engraftment of donor microbial strains in recipients appears to be key to the therapeutic success of FMT, both reviews note.
Three factors influence engraftment: the donor’s bacteria fitness relative to the recipient, the bacteria already present in the recipient, and whether antibiotics are used prior to FMT to open a niche for the incoming donor microbes, according to Dr. Yadegar and colleagues.
How to calculate strain engraftment has not yet been standardized in the field, and the number of strains detected in the recipient’s fecal sample is dependent on the depth of sequencing techniques, Dr. Porcari and colleagues note.
The use of whole-genome sequencing has enabled more precise evaluation of engraftment, they add.
“With this approach, microbial engraftment has been associated with clinical success, regardless of the disease, in a large metagenomic metanalysis of 24 FMT trials and almost 1,400 fecal samples,” Dr. Porcari and colleagues write. However, these results have not been replicated, likely because of differences between the studies.
More study on the topic is needed, both articles note.
“Because the recent metagenomics studies compared pre- and post-FMT only in cases with successful treatment outcomes, it is not possible to link engraftment to clinical outcomes,” Dr. Yadegar and colleagues write in their statement to this news organization.
A closer look at donor-recipient pairings
Clinicians usually enlist healthy, carefully screened individuals as FMT donors.
However, both research groups conclude that fine-scale taxonomic and metabolic analyses of donor and recipient microbiomes would better inform clinical decisions, especially when treating diseases other than C. difficile.
This may call for a more personalized approach to choosing donor-recipient pairings. Investigators should assess the patient’s diet and genetic background and how closely the donor’s microbiome matches that of the patient.
“Most studies focused on profiling stool samples before and after FMT without also including functional analyses; therefore, there are still a lot of aspects of host microbial interactions that remain unknown,” write Dr. Yadegar and colleagues in their statement.
Ecologic factors, including diet and host genetics, are often not included in clinical studies of C. difficile, but they “may potentially be the missing links” to treatment failure in the small portion of patients whose condition doesn’t respond to FMT, they write.
Pairing donor-recipient combinations on the basis of dietary patterns and preferences could improve FMT efficacy because the donor microbiota would be preadapted to the recipient’s diet, Dr. Yadegar and colleagues write. The team is examining how donor and recipient diet may affect outcomes.
Dr. Porcari and colleagues add that while some studies support the existence of shared characteristics that make up super-donors, others found that the optimal donor is more patient specific. They call for personalized selection strategies that employ microbiome sequencing tools rather than a “one stool fits all” approach.
Currently, many clinicians aren’t familiar with microbiome sequencing and analysis, but they’ll need to be in the near future, note Dr. Porcari and colleagues.
“Identifying microbiome characteristics that maximize strain engraftment in the FMT will allow clinicians to select the best donor for each single patient,” they write.
The possible role of viruses and fungi
In FMT research, investigators tend to focus on the bacteria in the human microbiome. However, viruses and fungi also appear to play a role, both articles note.
“Other microbial kingdoms that inhabit the intestine should be taken into account when considering predictors of post-FMT microbial transfer,” write Dr. Porcari and colleagues.
Although few studies have examined the gut virome’s impact on FMT effectiveness against C. difficile, the existing research, although limited, indicates that bacteriophage viruses could play a role, Dr. Yadegar and colleagues note. For example, high levels of donor-derived Caudoviralesbacteriophages in recipients were associated with FMT efficacy in one preliminary study, they write.
In a small human study, fecal filtrate from healthy donors who had bacteriophages but no live bacteria successfully treated five patients with recurrent C. difficile infection, Dr. Yadegar and colleagues write.
“Therefore, the idea that viruses may play a role is very provocative,” write Dr. Yadegar’s team in their statement.
It’s important to note that these studies are associative, which means they can’t definitively answer the question of how or whether viruses play a role, Dr. Yadegar’s team added.
Researchers “know even less about how fungi may or may not play a role,” write Dr. Yadegar and colleagues. However, in early research that involved patients who had successfully undergone FMT for C. difficile, there was higher relative abundance of Saccharomyces and Aspergillus, whereas Candida, if prominent, may impede response, they write in their article.
Additionally, to explore whether live bacteria are necessary for FMT to work, Dr. Yadegar and colleagues informed this news organization that they are conducting a study “comparing traditional FMT to a fecal filtrate that contains no live bacteria, but has all other components, to see if we can achieve similar success rates in recurrent C. difficile infection.”
Repeat treatment for sustained response
Dr. Yadegar’s team offered another important takeaway: A single FMT treatment will not sustain a positive response, especially when treating chronic noncommunicable conditions in which intestinal dysbiosis may play a role. Repeat treatment will be needed, as with other chronic conditions. This has been shown even in C. difficile infection.
“Recent studies have documented a significant advantage of repeated FMT over single FMT on the cure rates of recurrent C. difficile,” especially for patients with inflammatory bowel disorder, Dr. Yadegar’s team told this news organization.
“What we don’t know is which patient is likely to respond to microbial-based therapy, or what the dose or frequency should be, or which bacteria are responsible for the effects,” Dr. Yadegar and team said.
Dr. Porcari and colleagues are examining whether FMT could be refined to improve its success against other diseases. This may involve selecting specific donors, monitoring the gut microbiome of both donors and recipients, or using a specific means of delivery, such as lyophilized capsules, Dr. Ianiro said.
A response to FMT for chronic, noncommunicable disorders typically is not sustained long term, note Dr. Porcari and colleagues. However, they add that “sequential transplants have been applied in this setting with promising results, suggesting that chronic modulation of the patient microbiome may be beneficial in noncommunicable chronic disorders.” Dr. Porcari and colleagues point to the success of repeated, long-term FMT in studies of patients with ulcerative colitis and irritable bowel syndrome.
The use of cutting-edge technologies for microbiome assessment and a change in the view of FMT as only an acute, single-use therapy could improve FMT protocols and outcomes for noncommunicable conditions, they write.
Expanding FMT beyond C. difficile
Dr. Yadegar and colleagues’ article “really breaks down what is known about the mechanisms of FMT in C. difficile infection, which is important as other live biotherapeutic products are developed,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, R.I., who was not involved with the reviews, said in an interview.
Dr. Yadegar and colleagues concur. They note in a press release that as the mechanisms behind FMT success are understood, that information should be used to design new standardized therapies.
“Although highly effective, there are substantial drawbacks with [FMT], including infectious risks and sparse long-term safety data,” they write. “Better treatment options for recurrent C. difficile infections that are targeted, safe, and donor-independent are thus desired.”
In December 2022, the U.S. Food and Drug Administration approved the first fecal microbiota product, Rebyota, to prevent recurrence of C. difficile. More recently, in April 2023, the FDA approved Vowst, a pill for treating recurrent C. difficile infections.
Dr. Kelly also noted that the article by Dr. Yadegar and colleagues “may help us understand why a small percentage of patients fail to achieve cure after FMT.”
Regarding Dr. Porcari and colleagues’ article, Dr. Kelly said, “There is a lot of hope that FMT or other gut microbiome therapies will be beneficial for conditions outside of C. difficile.
“They do a good job reviewing the state of the science of FMT and highlight the many unknowns around the use of FMT in conditions outside of C. difficile,” added Dr. Kelly, who has been using FMT to treat C. difficile for more than 15 years.
Data supporting FMT for conditions such as ulcerative colitis and autism are compelling, Dr. Kelly acknowledged. But in her view, FMT isn’t ready for “prime time” outside of C. difficile – at least not yet.
“Academic investigators and those in industry are actively conducting research in many non–C. difficile indications, and I predict we will see the emergence of gut microbiome–based therapies for other indications within the next 5-10 years,” Dr. Kelly said.
Dr. Yadegar reports no relevant financial relationships. One coauthor of the Yadegar study has served on the adjudication board for Finch Therapeutics and has received consulting fees and a speaking honorarium from Rebiotix/Ferring Pharmaceuticals. Dr. Ianiro reports no relevant financial relationships. Dr. Kelly has consulted for Sebela Pharmaceuticals and is one of the principal investigators for the FMT National Patient Registry funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
A version of this article originally appeared on Medscape.com.
Should antibiotic treatment be used toward the end of life?
Diagnosing an infection is complex because of the presence of symptoms that are often nonspecific and that are common in patients in decline toward the end of life. Use of antibiotic therapy in this patient population is still controversial, because the clinical benefits are not clear and the risk of pointless overmedicalization is very high.
Etiology
For patients who are receiving palliative care, the following factors predispose to an infection:
- Increasing fragility.
- Bedbound status and anorexia/cachexia syndrome.
- Weakened immune defenses owing to disease or treatments.
- Changes to skin integrity, related to venous access sites and/or bladder catheterization.
Four-week cutoff
For patients who are expected to live for fewer than 4 weeks, evidence from the literature shows that antimicrobial therapy does not resolve a potential infection or improve the prognosis. Antibiotics should therefore be used only for improving symptom management.
In practice, the most common infections in patients receiving end-of-life care are in the urinary and respiratory tracts. Antibiotics are beneficial in the short term in managing symptoms associated with urinary tract infections (effective in 60%-92% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death.
Antibiotics are also beneficial in managing symptoms associated with respiratory tract infections (effective in up to 53% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death. However, the risk of futility is high. As an alternative, opioids and antitussives could provide greater benefit for patients with dyspnea and cough.
No benefit has been observed with the use of antibiotics to treat symptoms associated with sepsis, abscesses, and deep and complicated infections. Antibiotics are therefore deemed futile in these cases.
In unclear cases, the “2-day rule” is useful. This involves waiting for 2 days, and if the patient remains clinically stable, prescribing antibiotics. If the patient’s condition deteriorates rapidly and progressively, antibiotics should not be prescribed.
Alternatively, one can prescribe antibiotics immediately. If no clinical improvement is observed after 2 days, the antibiotics should be stopped, especially if deterioration of the patient’s condition is rapid and progressive.
Increased body temperature is somewhat common in the last days and hours of life and is not generally associated with symptoms. Fever in these cases is not an indication for the use of antimicrobial therapy.
The most common laboratory markers of infection (C-reactive protein level, erythrocyte sedimentation rate, leukocyte level) are not particularly useful in this patient population, because they are affected by the baseline condition as well as by any treatments given and the state of systemic inflammation, which is associated with the decline in overall health in the last few weeks of life.
The choice should be individualized and shared with patients and family members so that the clinical appropriateness of the therapeutic strategy is evident and that decisions regarding antibiotic treatment are not regarded as a failure to treat the patient.
The longer term
In deciding to start antibiotic therapy, consideration must be given to the patient’s overall health, the treatment objectives, the possibility that the antibiotic will resolve the infection or improve the patient’s symptoms, and the estimated prognosis, which must be sufficiently long to allow the antibiotic time to take effect.
This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.
Diagnosing an infection is complex because of the presence of symptoms that are often nonspecific and that are common in patients in decline toward the end of life. Use of antibiotic therapy in this patient population is still controversial, because the clinical benefits are not clear and the risk of pointless overmedicalization is very high.
Etiology
For patients who are receiving palliative care, the following factors predispose to an infection:
- Increasing fragility.
- Bedbound status and anorexia/cachexia syndrome.
- Weakened immune defenses owing to disease or treatments.
- Changes to skin integrity, related to venous access sites and/or bladder catheterization.
Four-week cutoff
For patients who are expected to live for fewer than 4 weeks, evidence from the literature shows that antimicrobial therapy does not resolve a potential infection or improve the prognosis. Antibiotics should therefore be used only for improving symptom management.
In practice, the most common infections in patients receiving end-of-life care are in the urinary and respiratory tracts. Antibiotics are beneficial in the short term in managing symptoms associated with urinary tract infections (effective in 60%-92% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death.
Antibiotics are also beneficial in managing symptoms associated with respiratory tract infections (effective in up to 53% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death. However, the risk of futility is high. As an alternative, opioids and antitussives could provide greater benefit for patients with dyspnea and cough.
No benefit has been observed with the use of antibiotics to treat symptoms associated with sepsis, abscesses, and deep and complicated infections. Antibiotics are therefore deemed futile in these cases.
In unclear cases, the “2-day rule” is useful. This involves waiting for 2 days, and if the patient remains clinically stable, prescribing antibiotics. If the patient’s condition deteriorates rapidly and progressively, antibiotics should not be prescribed.
Alternatively, one can prescribe antibiotics immediately. If no clinical improvement is observed after 2 days, the antibiotics should be stopped, especially if deterioration of the patient’s condition is rapid and progressive.
Increased body temperature is somewhat common in the last days and hours of life and is not generally associated with symptoms. Fever in these cases is not an indication for the use of antimicrobial therapy.
The most common laboratory markers of infection (C-reactive protein level, erythrocyte sedimentation rate, leukocyte level) are not particularly useful in this patient population, because they are affected by the baseline condition as well as by any treatments given and the state of systemic inflammation, which is associated with the decline in overall health in the last few weeks of life.
The choice should be individualized and shared with patients and family members so that the clinical appropriateness of the therapeutic strategy is evident and that decisions regarding antibiotic treatment are not regarded as a failure to treat the patient.
The longer term
In deciding to start antibiotic therapy, consideration must be given to the patient’s overall health, the treatment objectives, the possibility that the antibiotic will resolve the infection or improve the patient’s symptoms, and the estimated prognosis, which must be sufficiently long to allow the antibiotic time to take effect.
This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.
Diagnosing an infection is complex because of the presence of symptoms that are often nonspecific and that are common in patients in decline toward the end of life. Use of antibiotic therapy in this patient population is still controversial, because the clinical benefits are not clear and the risk of pointless overmedicalization is very high.
Etiology
For patients who are receiving palliative care, the following factors predispose to an infection:
- Increasing fragility.
- Bedbound status and anorexia/cachexia syndrome.
- Weakened immune defenses owing to disease or treatments.
- Changes to skin integrity, related to venous access sites and/or bladder catheterization.
Four-week cutoff
For patients who are expected to live for fewer than 4 weeks, evidence from the literature shows that antimicrobial therapy does not resolve a potential infection or improve the prognosis. Antibiotics should therefore be used only for improving symptom management.
In practice, the most common infections in patients receiving end-of-life care are in the urinary and respiratory tracts. Antibiotics are beneficial in the short term in managing symptoms associated with urinary tract infections (effective in 60%-92% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death.
Antibiotics are also beneficial in managing symptoms associated with respiratory tract infections (effective in up to 53% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death. However, the risk of futility is high. As an alternative, opioids and antitussives could provide greater benefit for patients with dyspnea and cough.
No benefit has been observed with the use of antibiotics to treat symptoms associated with sepsis, abscesses, and deep and complicated infections. Antibiotics are therefore deemed futile in these cases.
In unclear cases, the “2-day rule” is useful. This involves waiting for 2 days, and if the patient remains clinically stable, prescribing antibiotics. If the patient’s condition deteriorates rapidly and progressively, antibiotics should not be prescribed.
Alternatively, one can prescribe antibiotics immediately. If no clinical improvement is observed after 2 days, the antibiotics should be stopped, especially if deterioration of the patient’s condition is rapid and progressive.
Increased body temperature is somewhat common in the last days and hours of life and is not generally associated with symptoms. Fever in these cases is not an indication for the use of antimicrobial therapy.
The most common laboratory markers of infection (C-reactive protein level, erythrocyte sedimentation rate, leukocyte level) are not particularly useful in this patient population, because they are affected by the baseline condition as well as by any treatments given and the state of systemic inflammation, which is associated with the decline in overall health in the last few weeks of life.
The choice should be individualized and shared with patients and family members so that the clinical appropriateness of the therapeutic strategy is evident and that decisions regarding antibiotic treatment are not regarded as a failure to treat the patient.
The longer term
In deciding to start antibiotic therapy, consideration must be given to the patient’s overall health, the treatment objectives, the possibility that the antibiotic will resolve the infection or improve the patient’s symptoms, and the estimated prognosis, which must be sufficiently long to allow the antibiotic time to take effect.
This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.
The enemy of carcinogenic fumes is my friendly begonia
Sowing the seeds of cancer prevention
Are you looking to add to your quality of life, even though pets are not your speed? Might we suggest something with lower maintenance? Something a little greener?
Indoor plants can purify the air that comes from outside. Researchers at the University of Technology Sydney, in partnership with the plantscaping company Ambius, showed that a “green wall” made up of mixed indoor plants was able to suck up 97% of “the most toxic compounds” from the air in just 8 hours. We’re talking about lung-irritating, headache-inducing, cancer risk–boosting compounds from gasoline fumes, including benzene.
Public health initiatives often strive to reduce cardiovascular and obesity risks, but breathing seems pretty important too. According to the World Health Organization, household air pollution is responsible for about 2.5 million global premature deaths each year. And since 2020 we’ve become accustomed to spending more time inside and at home.
“This new research proves that plants should not just be seen as ‘nice to have,’ but rather a crucial part of every workplace wellness plan,” Ambius General Manager Johan Hodgson said in statement released by the university.
So don’t spend hundreds of dollars on a fancy air filtration system when a wall of plants can do that for next to nothing. Find what works for you and your space and become a plant parent today! Your lungs will thank you.
But officer, I had to swerve to miss the duodenal ampulla
Tiny video capsule endoscopes have been around for many years, but they have one big weakness: The ingestible cameras’ journey through the GI tract is passively driven by gravity and the natural movement of the body, so they often miss potential problem areas.
Not anymore. That flaw has been addressed by medical technology company AnX Robotica, which has taken endoscopy to the next level by adding that wondrous directional control device of the modern electronic age, a joystick.
The new system “uses an external magnet and hand-held video game style joysticks to move the capsule in three dimensions,” which allows physicians to “remotely drive a miniature video capsule to all regions of the stomach to visualize and photograph potential problem areas,” according to Andrew C. Meltzer, MD, of George Washington University and associates, who conducted a pilot study funded by AnX Robotica.
The video capsule provided a 95% rate of visualization in the stomachs of 40 patients who were examined at a medical office building by an emergency medicine physician who had no previous specialty training in endoscopy. “Capsules were driven by the ER physician and then the study reports were reviewed by an attending gastroenterologist who was physically off site,” the investigators said in a written statement.
The capsule operator did receive some additional training, and development of artificial intelligence to self-drive the capsule is in the works, but for now, we’re talking about a device controlled by a human using a joystick. And we all know that 50-year-olds are not especially known for their joystick skills. For that we need real experts. Yup, we need to put those joystick-controlled capsule endoscopes in the hands of teenage gamers. Who wants to go first?
Maybe AI isn’t ready for the big time after all
“How long before some intrepid stockholder says: ‘Hey, instead of paying doctors, why don’t we just use the free robot instead?’ ” Those words appeared on LOTME but a month ago. After all, the AI is supposed to be smarter and more empathetic than a doctor. And did we mention it’s free? Or at least extremely cheap. Cheaper than, say, a group of recently unionized health care workers.
In early May, the paid employees manning the National Eating Disorders Association emergency hotline voted to unionize, as they felt overwhelmed and underpaid. Apparently, paying six people an extra few thousand a year was too much for NEDA’s leadership, as they decided a few weeks later to fire those workers, fully closing down the hotline. Instead of talking to a real person, people “calling in” for support would be met with Tessa, a wellness chatbot that would hopefully guide them through their crisis. Key word, hopefully.
In perhaps the least surprising twist of the year, NEDA was forced to walk back its decision about a week after its initial announcement. It all started with a viral Instagram post from a woman who called in and received the following advice from Tessa: Lose 1-2 pounds a week, count calories and work for a 500- to 1,000-calorie deficit, weigh herself weekly, and restrict her diet. Unfortunately, all of these suggestions were things that led to the development of the woman’s eating disorder.
Naturally, NEDA responded in good grace, accusing the woman of lying. A NEDA vice president even left some nasty comments on the post, but hastily deleted them a day later when NEDA announced it was shutting down Tessa “until further notice for a complete investigation.” NEDA’s CEO insisted they hadn’t seen that behavior from Tessa before, calling it a “bug” and insisting the bot would only be down temporarily until the triggers causing the bug were fixed.
In the aftermath, several doctors and psychologists chimed in, terming the rush to automate human roles dangerous and risky. After all, much of what makes these hotlines effective is the volunteers speaking from their own experience. An unsupervised bot doesn’t seem to have what it takes to deal with a mental health crisis, but we’re betting that Tessa will be back. As a wise cephalopod once said: Nobody gives a care about the fate of labor as long as they can get their instant gratification.
You can’t spell existential without s-t-e-n-t
This week, we’re including a special “bonus” item that, to be honest, has nothing to do with stents. That’s why our editor is making us call this a “bonus” (and making us use quote marks, too): It doesn’t really have anything to do with stents or health care or those who practice health care. Actually, his exact words were, “You can’t just give the readers someone else’s ****ing list and expect to get paid for it.” Did we mention that he looks like Jack Nicklaus but acts like BoJack Horseman?
Anywaaay, we’re pretty sure that the list in question – “America’s Top 10 Most Googled Existential Questions” – says something about the human condition, just not about stents:
1. Why is the sky blue?
2. What do dreams mean?
3. What is the meaning of life?
4. Why am I so tired?
5. Who am I?
6. What is love?
7. Is a hot dog a sandwich?
8. What came first, the chicken or the egg?
9. What should I do?
10. Do animals have souls?
Sowing the seeds of cancer prevention
Are you looking to add to your quality of life, even though pets are not your speed? Might we suggest something with lower maintenance? Something a little greener?
Indoor plants can purify the air that comes from outside. Researchers at the University of Technology Sydney, in partnership with the plantscaping company Ambius, showed that a “green wall” made up of mixed indoor plants was able to suck up 97% of “the most toxic compounds” from the air in just 8 hours. We’re talking about lung-irritating, headache-inducing, cancer risk–boosting compounds from gasoline fumes, including benzene.
Public health initiatives often strive to reduce cardiovascular and obesity risks, but breathing seems pretty important too. According to the World Health Organization, household air pollution is responsible for about 2.5 million global premature deaths each year. And since 2020 we’ve become accustomed to spending more time inside and at home.
“This new research proves that plants should not just be seen as ‘nice to have,’ but rather a crucial part of every workplace wellness plan,” Ambius General Manager Johan Hodgson said in statement released by the university.
So don’t spend hundreds of dollars on a fancy air filtration system when a wall of plants can do that for next to nothing. Find what works for you and your space and become a plant parent today! Your lungs will thank you.
But officer, I had to swerve to miss the duodenal ampulla
Tiny video capsule endoscopes have been around for many years, but they have one big weakness: The ingestible cameras’ journey through the GI tract is passively driven by gravity and the natural movement of the body, so they often miss potential problem areas.
Not anymore. That flaw has been addressed by medical technology company AnX Robotica, which has taken endoscopy to the next level by adding that wondrous directional control device of the modern electronic age, a joystick.
The new system “uses an external magnet and hand-held video game style joysticks to move the capsule in three dimensions,” which allows physicians to “remotely drive a miniature video capsule to all regions of the stomach to visualize and photograph potential problem areas,” according to Andrew C. Meltzer, MD, of George Washington University and associates, who conducted a pilot study funded by AnX Robotica.
The video capsule provided a 95% rate of visualization in the stomachs of 40 patients who were examined at a medical office building by an emergency medicine physician who had no previous specialty training in endoscopy. “Capsules were driven by the ER physician and then the study reports were reviewed by an attending gastroenterologist who was physically off site,” the investigators said in a written statement.
The capsule operator did receive some additional training, and development of artificial intelligence to self-drive the capsule is in the works, but for now, we’re talking about a device controlled by a human using a joystick. And we all know that 50-year-olds are not especially known for their joystick skills. For that we need real experts. Yup, we need to put those joystick-controlled capsule endoscopes in the hands of teenage gamers. Who wants to go first?
Maybe AI isn’t ready for the big time after all
“How long before some intrepid stockholder says: ‘Hey, instead of paying doctors, why don’t we just use the free robot instead?’ ” Those words appeared on LOTME but a month ago. After all, the AI is supposed to be smarter and more empathetic than a doctor. And did we mention it’s free? Or at least extremely cheap. Cheaper than, say, a group of recently unionized health care workers.
In early May, the paid employees manning the National Eating Disorders Association emergency hotline voted to unionize, as they felt overwhelmed and underpaid. Apparently, paying six people an extra few thousand a year was too much for NEDA’s leadership, as they decided a few weeks later to fire those workers, fully closing down the hotline. Instead of talking to a real person, people “calling in” for support would be met with Tessa, a wellness chatbot that would hopefully guide them through their crisis. Key word, hopefully.
In perhaps the least surprising twist of the year, NEDA was forced to walk back its decision about a week after its initial announcement. It all started with a viral Instagram post from a woman who called in and received the following advice from Tessa: Lose 1-2 pounds a week, count calories and work for a 500- to 1,000-calorie deficit, weigh herself weekly, and restrict her diet. Unfortunately, all of these suggestions were things that led to the development of the woman’s eating disorder.
Naturally, NEDA responded in good grace, accusing the woman of lying. A NEDA vice president even left some nasty comments on the post, but hastily deleted them a day later when NEDA announced it was shutting down Tessa “until further notice for a complete investigation.” NEDA’s CEO insisted they hadn’t seen that behavior from Tessa before, calling it a “bug” and insisting the bot would only be down temporarily until the triggers causing the bug were fixed.
In the aftermath, several doctors and psychologists chimed in, terming the rush to automate human roles dangerous and risky. After all, much of what makes these hotlines effective is the volunteers speaking from their own experience. An unsupervised bot doesn’t seem to have what it takes to deal with a mental health crisis, but we’re betting that Tessa will be back. As a wise cephalopod once said: Nobody gives a care about the fate of labor as long as they can get their instant gratification.
You can’t spell existential without s-t-e-n-t
This week, we’re including a special “bonus” item that, to be honest, has nothing to do with stents. That’s why our editor is making us call this a “bonus” (and making us use quote marks, too): It doesn’t really have anything to do with stents or health care or those who practice health care. Actually, his exact words were, “You can’t just give the readers someone else’s ****ing list and expect to get paid for it.” Did we mention that he looks like Jack Nicklaus but acts like BoJack Horseman?
Anywaaay, we’re pretty sure that the list in question – “America’s Top 10 Most Googled Existential Questions” – says something about the human condition, just not about stents:
1. Why is the sky blue?
2. What do dreams mean?
3. What is the meaning of life?
4. Why am I so tired?
5. Who am I?
6. What is love?
7. Is a hot dog a sandwich?
8. What came first, the chicken or the egg?
9. What should I do?
10. Do animals have souls?
Sowing the seeds of cancer prevention
Are you looking to add to your quality of life, even though pets are not your speed? Might we suggest something with lower maintenance? Something a little greener?
Indoor plants can purify the air that comes from outside. Researchers at the University of Technology Sydney, in partnership with the plantscaping company Ambius, showed that a “green wall” made up of mixed indoor plants was able to suck up 97% of “the most toxic compounds” from the air in just 8 hours. We’re talking about lung-irritating, headache-inducing, cancer risk–boosting compounds from gasoline fumes, including benzene.
Public health initiatives often strive to reduce cardiovascular and obesity risks, but breathing seems pretty important too. According to the World Health Organization, household air pollution is responsible for about 2.5 million global premature deaths each year. And since 2020 we’ve become accustomed to spending more time inside and at home.
“This new research proves that plants should not just be seen as ‘nice to have,’ but rather a crucial part of every workplace wellness plan,” Ambius General Manager Johan Hodgson said in statement released by the university.
So don’t spend hundreds of dollars on a fancy air filtration system when a wall of plants can do that for next to nothing. Find what works for you and your space and become a plant parent today! Your lungs will thank you.
But officer, I had to swerve to miss the duodenal ampulla
Tiny video capsule endoscopes have been around for many years, but they have one big weakness: The ingestible cameras’ journey through the GI tract is passively driven by gravity and the natural movement of the body, so they often miss potential problem areas.
Not anymore. That flaw has been addressed by medical technology company AnX Robotica, which has taken endoscopy to the next level by adding that wondrous directional control device of the modern electronic age, a joystick.
The new system “uses an external magnet and hand-held video game style joysticks to move the capsule in three dimensions,” which allows physicians to “remotely drive a miniature video capsule to all regions of the stomach to visualize and photograph potential problem areas,” according to Andrew C. Meltzer, MD, of George Washington University and associates, who conducted a pilot study funded by AnX Robotica.
The video capsule provided a 95% rate of visualization in the stomachs of 40 patients who were examined at a medical office building by an emergency medicine physician who had no previous specialty training in endoscopy. “Capsules were driven by the ER physician and then the study reports were reviewed by an attending gastroenterologist who was physically off site,” the investigators said in a written statement.
The capsule operator did receive some additional training, and development of artificial intelligence to self-drive the capsule is in the works, but for now, we’re talking about a device controlled by a human using a joystick. And we all know that 50-year-olds are not especially known for their joystick skills. For that we need real experts. Yup, we need to put those joystick-controlled capsule endoscopes in the hands of teenage gamers. Who wants to go first?
Maybe AI isn’t ready for the big time after all
“How long before some intrepid stockholder says: ‘Hey, instead of paying doctors, why don’t we just use the free robot instead?’ ” Those words appeared on LOTME but a month ago. After all, the AI is supposed to be smarter and more empathetic than a doctor. And did we mention it’s free? Or at least extremely cheap. Cheaper than, say, a group of recently unionized health care workers.
In early May, the paid employees manning the National Eating Disorders Association emergency hotline voted to unionize, as they felt overwhelmed and underpaid. Apparently, paying six people an extra few thousand a year was too much for NEDA’s leadership, as they decided a few weeks later to fire those workers, fully closing down the hotline. Instead of talking to a real person, people “calling in” for support would be met with Tessa, a wellness chatbot that would hopefully guide them through their crisis. Key word, hopefully.
In perhaps the least surprising twist of the year, NEDA was forced to walk back its decision about a week after its initial announcement. It all started with a viral Instagram post from a woman who called in and received the following advice from Tessa: Lose 1-2 pounds a week, count calories and work for a 500- to 1,000-calorie deficit, weigh herself weekly, and restrict her diet. Unfortunately, all of these suggestions were things that led to the development of the woman’s eating disorder.
Naturally, NEDA responded in good grace, accusing the woman of lying. A NEDA vice president even left some nasty comments on the post, but hastily deleted them a day later when NEDA announced it was shutting down Tessa “until further notice for a complete investigation.” NEDA’s CEO insisted they hadn’t seen that behavior from Tessa before, calling it a “bug” and insisting the bot would only be down temporarily until the triggers causing the bug were fixed.
In the aftermath, several doctors and psychologists chimed in, terming the rush to automate human roles dangerous and risky. After all, much of what makes these hotlines effective is the volunteers speaking from their own experience. An unsupervised bot doesn’t seem to have what it takes to deal with a mental health crisis, but we’re betting that Tessa will be back. As a wise cephalopod once said: Nobody gives a care about the fate of labor as long as they can get their instant gratification.
You can’t spell existential without s-t-e-n-t
This week, we’re including a special “bonus” item that, to be honest, has nothing to do with stents. That’s why our editor is making us call this a “bonus” (and making us use quote marks, too): It doesn’t really have anything to do with stents or health care or those who practice health care. Actually, his exact words were, “You can’t just give the readers someone else’s ****ing list and expect to get paid for it.” Did we mention that he looks like Jack Nicklaus but acts like BoJack Horseman?
Anywaaay, we’re pretty sure that the list in question – “America’s Top 10 Most Googled Existential Questions” – says something about the human condition, just not about stents:
1. Why is the sky blue?
2. What do dreams mean?
3. What is the meaning of life?
4. Why am I so tired?
5. Who am I?
6. What is love?
7. Is a hot dog a sandwich?
8. What came first, the chicken or the egg?
9. What should I do?
10. Do animals have souls?