HMG-CoA reductase inhibitors (statins) have been shown to effectively reduce low-density lipoprotein cholesterol (LDL-C) as well as morbidity and mortality in patients who have either atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD.^1-12 However, research shows that up to 20% of patients are unable to tolerate statin therapy due to muscle-related adverse events (AEs).¹³ This presents a substantial clinical challenge, as current management strategies for patients with statin-associated muscle symptoms, such as intermittent administration of statins and ezetimibe, seldom achieve the > 50% LDL-C reduction recommended by the 2018 American Heart Association/American College of Cardiology Clinical Practice Guidelines.¹⁴ Additionally, statin-intolerant patients who have antihyperlipidemic medication lowered or discontinued are at an increased risk of future cardiovascular events.¹⁵ Observational data also show that about 70% of adult patients (primarily with genetic lipid disorders such as heterozygous familial hypercholesterolemia) do not achieve an LDL-C level < 100 mg/dL despite treatment with maximum doses of statins with or without ezetimibe.^16,17

PCSK9 inhibitors (PCSK9i) have robust efficacy data to support use in patients who do not meet their LDL-C goal despite maximally tolerated lipid therapy.¹⁴ However, long-term safety data for PCSK9i are not as robust as its efficacy data. Specifically, safety data relating to muscle-related AEs, which are the most widely recognized AE associated with statins, have only been reported in a few clinical trials with varying incidence rates, levels of significance, and relatively small study populations. Furthermore, the real-world prevalence of muscle-related PCSK9i AEs is unknown. Clinical guidance for management strategies for muscle-related AEs associated with PCSK9i is largely lacking. For this study, muscle-related AEs were defined as any new or unusual muscle soreness, weakness, cramping, aches, and stiffness that persists, is generally bilateral, and typically affects the large muscles. It is important to note, that muscle-related AEs associated with statins, ezetimibe, and PCSK9i can be attributed to the nocebo effect.

According to the prescribing information for alirocumab and evolocumab, myalgia, muscle spasms, and musculoskeletal pain each occurred in < 5% of the study populations.^18,19 From these data, muscle-related PCSK9i AEs are thought to be relatively rare, based on the ODYSSEY-OUTCOME and FOURIER trials, which did not enroll statin-intolerant patients.^20,21 However, currently available safety data from 3 small, randomized clinical trials specifically in statin-intolerant patients taking a PCSK9i suggest that muscle-related AEs occur at a rate of 12.2% to 32.5% and discontinuation rates varied from 0% to 15.9%.^22-25 As the incidence rates of muscle-related AEs in the prescribing information and clinical trials varied widely, this study will provide quantitative data on the percentage of patients that developed muscle-related PCSK9i AEs in a veteran population to help shed light on a topic that is not well studied.

Methods

This was a single-center, retrospective chart review of patients prescribed a PCSK9i between December 1, 2017, and September 1, 2021, and were managed in a pharmacy-led patient aligned care team (PACT) clinic at the Wilkes-Barre US Department of Veterans Affairs (VA) Medical Center (WBVAMC) in Pennsylvania. This study was approved by the Coatesville VA Medical Center Institutional Review Board, which oversees research conducted at WBVAMC. Veterans aged ≥ 18 years were included in the study. Patients were excluded if they had a history of serious hypersensitivity reaction to a PCSK9i or rhabdomyolysis or did not meet the VA criteria for use.²⁶

The primary outcome was the percentage of patients who developed a muscle-related AE while on a PCSK9i in a PACT clinic. Data were further analyzed based on patients who (1) tolerated a full PCSK9i dose; (2) tolerated alternative PCSK9i following initial intolerance; (3) required a PCSK9i dose reduction, or (4) discontinued PCSK9i. A secondary outcome was the percentage of statin- and/or ezetimibe-intolerant patients in these 4 groups. Another secondary outcome was the management strategies taken for patients who were on a reduced (monthly) dose of PCSK9i who did not reach their LDL-C goal. Management strategies that were assessed included restarting weekly statin, restarting weekly ezetimibe, increasing the dose of the same PCSK9i administered monthly, and switching to an alternative PCSK9i.

Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a secure, locked spreadsheet. Baseline patient demographic characteristics collected included age (at PCSK9i start); sex; race; and PCSK9i name, dose, and frequency. We recorded when a patient switched PCSK9i, whether or not it was due to a muscle-related AE, and the name of the original PCSK9i. Also collected were lipid therapy intolerances prior to PCSK9i initiation (ie, intolerance to statin, ezetimibe, or both).

Patients were considered statin intolerant due to a muscle-related AE in accordance with the VA PCSK9i Criteria for Use, which requires trial of at least 3 statins, one of which was trialed at the lowest dosage approved by the US Food and Drug Administration (FDA) and resulted in intolerable skeletal muscle AEs that worsened during treatment and resolved when the statin was stopped. For our study purposes, patients taking alternative day dosing of statins due to muscle-related AEs (ie, 2- or 3-times weekly dosing) were not considered statin intolerant; however, patients taking once-weekly statin dosing were considered statin intolerant. Patients were considered ezetimibe intolerant due to a muscle-related AE if the intolerance was due to skeletal muscle concerns that worsened during treatment and resolved when ezetimibe was stopped. Patients were considered PCSK9i intolerant due to a muscle-related AE if the intolerance was due to skeletal muscle concerns that worsened during treatment and resolved when the PCSK9i was stopped. Patients with non–muscle-related intolerances to statins, ezetimibe, and PCSK9i were not considered statin, ezetimibe, and PCSK9i intolerant.

Alirocumab was initiated at 75 mg subcutaneous (SQ) once every 2 weeks or evolocumab 140 mg SQ once every 2 weeks in our study. The protocol allowed for a dose reduction of alirocumab 75 mg SQ once monthly if a patient experienced AEs, but this dose reduction strategy was not used for any patients on evolocumab in this study. Of note, alirocumab 75 mg SQ once monthly is not an FDA-approved dosing strategy. However, it is similar in concept to the alternative statin dosing (ie, alternate day dosing, once-weekly dosing) and may avoid the need to discontinue PCSK9i therapy altogether.

A review of the CPRS also documented whether a muscle-related AE occurred while the patient was on a PCSK9i (if yes, the specific AE was recorded), the result of PCSK9i therapy (tolerated full dose, required a dose reduction, switched medication, or discontinued), and management strategies taken for patients who did not meet their LDL-C goal while on a reduced (monthly) PCSK9i dose. Prior lipid therapy intolerances, PCSK9i-related AEs, results of PCSK9i therapy, and management strategies for patients who did not meet LDL-C goal while on a reduced PCSK9i dose were obtained by reviewing the PACT pharmacist’s clinic notes and assessment, along with clinic notes and medication history listed within the CPRS.

Statistical Analysis

Descriptive statistics were used for the demographic characteristics of study patients. The primary outcome was calculated as a binary measure (yes/no) of whether the patient developed a muscle-related AE while on a PCSK9i. The secondary outcome of statin, ezetimibe, or statin and ezetimibe intolerances in subgroups also was calculated as a binary measure.

Results

For the study, 156 charts were reviewed and 137 patients were included (Figure).

For the secondary results, 4 patients (2.9%) tolerated an alternate PCSK9i (evolocumab 140 mg SQ every 2 weeks) after initial intolerance to PCSK9i, 16 (11.7%) required a dose reduction, and 6 (4.4%) discontinued PCSK9i due to a muscle-related AE.

Discussion

This retrospective study found 17.5% of patients experienced muscle-related PCSK9i AEs. These occurred at a higher rate than reported in the prescribing information (< 5%) and were similar to the incidence rates reported in the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE clinical trials (12.0%-32.5%), which is what we hypothesized.^18,19,22-25 It is important to note that the incidence rates of muscle-related AEs reported in the prescribing information for alirocumab and evolocumab were based on trials that did not include statin- and/or ezetimibe-intolerant patients; whereas many patients in our study and patients in the clinical trials were statin and/or ezetimibe intolerant.

Additionally, a new study by Donald and colleagues found an incidence rate of 32% to 36% for muscle-related PCSK9i AEs.²⁷ Collectively, the data from clinical trials and our study indicate that patients with prior intolerances to statin and/or ezetimibe appear to have a higher likelihood of developing a muscle-related PCSK9i intolerance. In our study, 23 of 24 patients who developed a muscle-related PCSK9i AE had a prior history of statin and/or ezetimibe intolerances. This should alert clinicians prescribing PCSK9i in patients with a history of statin and/or ezetimibe intolerance to counsel their patients on the possibility of muscle-related PCSK9i AEs and management strategies. However, it is important to note that there was a substantial number of patients in our study who were statin and/or ezetimibe intolerant due to a prior muscle-related AE who tolerated the full dose of PCSK9i.

To our knowledge, this was the first trial to evaluate muscle-related PCSK9i AEs in a veteran population. Additionally, our study appears to be the first to use 2 PCSK9i dosing strategies that are not FDA approved: Dose reduction for patients who experienced a muscle-related AE on alirocumab 75 mg SQ every 2 weeks and dose escalation for patients who did not meet their LDL-C goal on alirocumab 75 mg SQ monthly following an initial intolerance to 2-week dosing. The dose-reduction strategy allowed patients who experienced a muscle-related AE to alirocumab 75 mg to reduce administration from every 2 weeks to monthly.

This strategy was only performed with alirocumab, the preferred PCSK9i at WBVAMC, but the same dose-reduction strategy can theoretically be used with evolocumab as well. Reduced monthly dosing of alirocumab allowed patients with a prior intolerance to remain on a lower dosage without discontinuation. This is important because as noted by Myers and colleagues, individuals without access to PCSK9i were found to have a significantly higher incidence ratio of cardiovascular events compared with those taking PCSK9i.¹⁵ Also of note, > 30% of patients on the reduced monthly dose of alirocumab still met their LDL-C goal. Therefore, using this dose-reduction strategy (instead of patients discontinuing therapy altogether due to a muscle-related intolerance) can lessen the risk of major adverse cardiovascular events (MACE) as well as mitigate muscle-related AEs that occurred while on 2-week PCSK9i dosing regimens. While we acknowledge that this reduced monthly dose of either alirocumab or evolocumab is not FDA approved, it is similar to alternative statin dosing that also is not FDA approved but may minimize the need to discontinue PCSK9i therapy. It would be beneficial if these dosing strategies were investigated by future research.

The dose-escalation strategy for patients who did not meet their LDL-C goal while on the reduced, monthly dose of alirocumab also was unique. Alirocumab was increased from 75 mg SQ once monthly to 150 mg SQ once monthly. Interestingly, we found that through the end of the chart review period, all patients tolerated the increase well, despite having an initial muscle-related AE to alirocumab 75 mg every 2 weeks, which is the same total monthly dosage. This approach is similar to that of once-weekly statin dosing or a drug holiday and may be explained by the long half-life of PCSK9i. Regardless of the mechanism, this finding suggests that an increased monthly dose of PCSK9i is a potential alternative for patients who cannot tolerate the FDA-approved dose. However, the ability for patients to achieve goal LDL-C on the monthly dosage requires future study.

Limitations

The results of this study should be considered with the following limitations. First, this was a retrospective chart review performed over a prespecified period. Any muscle-related AEs or LDL-C lowering effects from PCSK9i that occurred outside the review period were not captured. Our study was small and only included 137 patients, though it was similar in size to the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE trials.^22-24 Additionally, the study was primarily composed of White men and may not be representative of other populations. Some muscle-related PCSK9i AEs may be attributed to the nocebo. Last, our study did not capture patients on a PCSK9i who were not followed in the PACT clinic.

Conclusions

We found that muscle-related PCSK9i AEs occurred at a similar rate as those reported in previous clinical trials and exceeded the incidence rate reported in the prescribing information for alirocumab and evolocumab. It appears that patients who have a prior muscle-related intolerance to a statin and/or ezetimibe had a higher likelihood of developing a muscle-related PCSK9i AE. In our study, only 1 patient developed a muscle-related PCSK9i AE who did not have a prior history of muscle-related intolerance to either a statin or ezetimibe. However, in our study, a substantial percentage of patients with statin and/or ezetimibe intolerances tolerated the full PCSK9i dose well, proving that PCSK9i are still a reasonable alternative for patients with prior intolerances to statins and/or ezetimibe.

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the US Department of Veterans Affairs Medical Center, Wilkes-Barre, Pennsylvania.

HMG-CoA reductase inhibitors (statins) have been shown to effectively reduce low-density lipoprotein cholesterol (LDL-C) as well as morbidity and mortality in patients who have either atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD.^1-12 However, research shows that up to 20% of patients are unable to tolerate statin therapy due to muscle-related adverse events (AEs).¹³ This presents a substantial clinical challenge, as current management strategies for patients with statin-associated muscle symptoms, such as intermittent administration of statins and ezetimibe, seldom achieve the > 50% LDL-C reduction recommended by the 2018 American Heart Association/American College of Cardiology Clinical Practice Guidelines.¹⁴ Additionally, statin-intolerant patients who have antihyperlipidemic medication lowered or discontinued are at an increased risk of future cardiovascular events.¹⁵ Observational data also show that about 70% of adult patients (primarily with genetic lipid disorders such as heterozygous familial hypercholesterolemia) do not achieve an LDL-C level < 100 mg/dL despite treatment with maximum doses of statins with or without ezetimibe.^16,17

PCSK9 inhibitors (PCSK9i) have robust efficacy data to support use in patients who do not meet their LDL-C goal despite maximally tolerated lipid therapy.¹⁴ However, long-term safety data for PCSK9i are not as robust as its efficacy data. Specifically, safety data relating to muscle-related AEs, which are the most widely recognized AE associated with statins, have only been reported in a few clinical trials with varying incidence rates, levels of significance, and relatively small study populations. Furthermore, the real-world prevalence of muscle-related PCSK9i AEs is unknown. Clinical guidance for management strategies for muscle-related AEs associated with PCSK9i is largely lacking. For this study, muscle-related AEs were defined as any new or unusual muscle soreness, weakness, cramping, aches, and stiffness that persists, is generally bilateral, and typically affects the large muscles. It is important to note, that muscle-related AEs associated with statins, ezetimibe, and PCSK9i can be attributed to the nocebo effect.

According to the prescribing information for alirocumab and evolocumab, myalgia, muscle spasms, and musculoskeletal pain each occurred in < 5% of the study populations.^18,19 From these data, muscle-related PCSK9i AEs are thought to be relatively rare, based on the ODYSSEY-OUTCOME and FOURIER trials, which did not enroll statin-intolerant patients.^20,21 However, currently available safety data from 3 small, randomized clinical trials specifically in statin-intolerant patients taking a PCSK9i suggest that muscle-related AEs occur at a rate of 12.2% to 32.5% and discontinuation rates varied from 0% to 15.9%.^22-25 As the incidence rates of muscle-related AEs in the prescribing information and clinical trials varied widely, this study will provide quantitative data on the percentage of patients that developed muscle-related PCSK9i AEs in a veteran population to help shed light on a topic that is not well studied.

Methods

This was a single-center, retrospective chart review of patients prescribed a PCSK9i between December 1, 2017, and September 1, 2021, and were managed in a pharmacy-led patient aligned care team (PACT) clinic at the Wilkes-Barre US Department of Veterans Affairs (VA) Medical Center (WBVAMC) in Pennsylvania. This study was approved by the Coatesville VA Medical Center Institutional Review Board, which oversees research conducted at WBVAMC. Veterans aged ≥ 18 years were included in the study. Patients were excluded if they had a history of serious hypersensitivity reaction to a PCSK9i or rhabdomyolysis or did not meet the VA criteria for use.²⁶

The primary outcome was the percentage of patients who developed a muscle-related AE while on a PCSK9i in a PACT clinic. Data were further analyzed based on patients who (1) tolerated a full PCSK9i dose; (2) tolerated alternative PCSK9i following initial intolerance; (3) required a PCSK9i dose reduction, or (4) discontinued PCSK9i. A secondary outcome was the percentage of statin- and/or ezetimibe-intolerant patients in these 4 groups. Another secondary outcome was the management strategies taken for patients who were on a reduced (monthly) dose of PCSK9i who did not reach their LDL-C goal. Management strategies that were assessed included restarting weekly statin, restarting weekly ezetimibe, increasing the dose of the same PCSK9i administered monthly, and switching to an alternative PCSK9i.

Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a secure, locked spreadsheet. Baseline patient demographic characteristics collected included age (at PCSK9i start); sex; race; and PCSK9i name, dose, and frequency. We recorded when a patient switched PCSK9i, whether or not it was due to a muscle-related AE, and the name of the original PCSK9i. Also collected were lipid therapy intolerances prior to PCSK9i initiation (ie, intolerance to statin, ezetimibe, or both).

Patients were considered statin intolerant due to a muscle-related AE in accordance with the VA PCSK9i Criteria for Use, which requires trial of at least 3 statins, one of which was trialed at the lowest dosage approved by the US Food and Drug Administration (FDA) and resulted in intolerable skeletal muscle AEs that worsened during treatment and resolved when the statin was stopped. For our study purposes, patients taking alternative day dosing of statins due to muscle-related AEs (ie, 2- or 3-times weekly dosing) were not considered statin intolerant; however, patients taking once-weekly statin dosing were considered statin intolerant. Patients were considered ezetimibe intolerant due to a muscle-related AE if the intolerance was due to skeletal muscle concerns that worsened during treatment and resolved when ezetimibe was stopped. Patients were considered PCSK9i intolerant due to a muscle-related AE if the intolerance was due to skeletal muscle concerns that worsened during treatment and resolved when the PCSK9i was stopped. Patients with non–muscle-related intolerances to statins, ezetimibe, and PCSK9i were not considered statin, ezetimibe, and PCSK9i intolerant.

Alirocumab was initiated at 75 mg subcutaneous (SQ) once every 2 weeks or evolocumab 140 mg SQ once every 2 weeks in our study. The protocol allowed for a dose reduction of alirocumab 75 mg SQ once monthly if a patient experienced AEs, but this dose reduction strategy was not used for any patients on evolocumab in this study. Of note, alirocumab 75 mg SQ once monthly is not an FDA-approved dosing strategy. However, it is similar in concept to the alternative statin dosing (ie, alternate day dosing, once-weekly dosing) and may avoid the need to discontinue PCSK9i therapy altogether.

A review of the CPRS also documented whether a muscle-related AE occurred while the patient was on a PCSK9i (if yes, the specific AE was recorded), the result of PCSK9i therapy (tolerated full dose, required a dose reduction, switched medication, or discontinued), and management strategies taken for patients who did not meet their LDL-C goal while on a reduced (monthly) PCSK9i dose. Prior lipid therapy intolerances, PCSK9i-related AEs, results of PCSK9i therapy, and management strategies for patients who did not meet LDL-C goal while on a reduced PCSK9i dose were obtained by reviewing the PACT pharmacist’s clinic notes and assessment, along with clinic notes and medication history listed within the CPRS.

Statistical Analysis

Descriptive statistics were used for the demographic characteristics of study patients. The primary outcome was calculated as a binary measure (yes/no) of whether the patient developed a muscle-related AE while on a PCSK9i. The secondary outcome of statin, ezetimibe, or statin and ezetimibe intolerances in subgroups also was calculated as a binary measure.

Results

For the study, 156 charts were reviewed and 137 patients were included (Figure).

For the secondary results, 4 patients (2.9%) tolerated an alternate PCSK9i (evolocumab 140 mg SQ every 2 weeks) after initial intolerance to PCSK9i, 16 (11.7%) required a dose reduction, and 6 (4.4%) discontinued PCSK9i due to a muscle-related AE.

Discussion

This retrospective study found 17.5% of patients experienced muscle-related PCSK9i AEs. These occurred at a higher rate than reported in the prescribing information (< 5%) and were similar to the incidence rates reported in the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE clinical trials (12.0%-32.5%), which is what we hypothesized.^18,19,22-25 It is important to note that the incidence rates of muscle-related AEs reported in the prescribing information for alirocumab and evolocumab were based on trials that did not include statin- and/or ezetimibe-intolerant patients; whereas many patients in our study and patients in the clinical trials were statin and/or ezetimibe intolerant.

Additionally, a new study by Donald and colleagues found an incidence rate of 32% to 36% for muscle-related PCSK9i AEs.²⁷ Collectively, the data from clinical trials and our study indicate that patients with prior intolerances to statin and/or ezetimibe appear to have a higher likelihood of developing a muscle-related PCSK9i intolerance. In our study, 23 of 24 patients who developed a muscle-related PCSK9i AE had a prior history of statin and/or ezetimibe intolerances. This should alert clinicians prescribing PCSK9i in patients with a history of statin and/or ezetimibe intolerance to counsel their patients on the possibility of muscle-related PCSK9i AEs and management strategies. However, it is important to note that there was a substantial number of patients in our study who were statin and/or ezetimibe intolerant due to a prior muscle-related AE who tolerated the full dose of PCSK9i.

To our knowledge, this was the first trial to evaluate muscle-related PCSK9i AEs in a veteran population. Additionally, our study appears to be the first to use 2 PCSK9i dosing strategies that are not FDA approved: Dose reduction for patients who experienced a muscle-related AE on alirocumab 75 mg SQ every 2 weeks and dose escalation for patients who did not meet their LDL-C goal on alirocumab 75 mg SQ monthly following an initial intolerance to 2-week dosing. The dose-reduction strategy allowed patients who experienced a muscle-related AE to alirocumab 75 mg to reduce administration from every 2 weeks to monthly.

This strategy was only performed with alirocumab, the preferred PCSK9i at WBVAMC, but the same dose-reduction strategy can theoretically be used with evolocumab as well. Reduced monthly dosing of alirocumab allowed patients with a prior intolerance to remain on a lower dosage without discontinuation. This is important because as noted by Myers and colleagues, individuals without access to PCSK9i were found to have a significantly higher incidence ratio of cardiovascular events compared with those taking PCSK9i.¹⁵ Also of note, > 30% of patients on the reduced monthly dose of alirocumab still met their LDL-C goal. Therefore, using this dose-reduction strategy (instead of patients discontinuing therapy altogether due to a muscle-related intolerance) can lessen the risk of major adverse cardiovascular events (MACE) as well as mitigate muscle-related AEs that occurred while on 2-week PCSK9i dosing regimens. While we acknowledge that this reduced monthly dose of either alirocumab or evolocumab is not FDA approved, it is similar to alternative statin dosing that also is not FDA approved but may minimize the need to discontinue PCSK9i therapy. It would be beneficial if these dosing strategies were investigated by future research.

The dose-escalation strategy for patients who did not meet their LDL-C goal while on the reduced, monthly dose of alirocumab also was unique. Alirocumab was increased from 75 mg SQ once monthly to 150 mg SQ once monthly. Interestingly, we found that through the end of the chart review period, all patients tolerated the increase well, despite having an initial muscle-related AE to alirocumab 75 mg every 2 weeks, which is the same total monthly dosage. This approach is similar to that of once-weekly statin dosing or a drug holiday and may be explained by the long half-life of PCSK9i. Regardless of the mechanism, this finding suggests that an increased monthly dose of PCSK9i is a potential alternative for patients who cannot tolerate the FDA-approved dose. However, the ability for patients to achieve goal LDL-C on the monthly dosage requires future study.

Limitations

The results of this study should be considered with the following limitations. First, this was a retrospective chart review performed over a prespecified period. Any muscle-related AEs or LDL-C lowering effects from PCSK9i that occurred outside the review period were not captured. Our study was small and only included 137 patients, though it was similar in size to the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE trials.^22-24 Additionally, the study was primarily composed of White men and may not be representative of other populations. Some muscle-related PCSK9i AEs may be attributed to the nocebo. Last, our study did not capture patients on a PCSK9i who were not followed in the PACT clinic.

Conclusions

We found that muscle-related PCSK9i AEs occurred at a similar rate as those reported in previous clinical trials and exceeded the incidence rate reported in the prescribing information for alirocumab and evolocumab. It appears that patients who have a prior muscle-related intolerance to a statin and/or ezetimibe had a higher likelihood of developing a muscle-related PCSK9i AE. In our study, only 1 patient developed a muscle-related PCSK9i AE who did not have a prior history of muscle-related intolerance to either a statin or ezetimibe. However, in our study, a substantial percentage of patients with statin and/or ezetimibe intolerances tolerated the full PCSK9i dose well, proving that PCSK9i are still a reasonable alternative for patients with prior intolerances to statins and/or ezetimibe.

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the US Department of Veterans Affairs Medical Center, Wilkes-Barre, Pennsylvania.

HMG-CoA reductase inhibitors (statins) have been shown to effectively reduce low-density lipoprotein cholesterol (LDL-C) as well as morbidity and mortality in patients who have either atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD.^1-12 However, research shows that up to 20% of patients are unable to tolerate statin therapy due to muscle-related adverse events (AEs).¹³ This presents a substantial clinical challenge, as current management strategies for patients with statin-associated muscle symptoms, such as intermittent administration of statins and ezetimibe, seldom achieve the > 50% LDL-C reduction recommended by the 2018 American Heart Association/American College of Cardiology Clinical Practice Guidelines.¹⁴ Additionally, statin-intolerant patients who have antihyperlipidemic medication lowered or discontinued are at an increased risk of future cardiovascular events.¹⁵ Observational data also show that about 70% of adult patients (primarily with genetic lipid disorders such as heterozygous familial hypercholesterolemia) do not achieve an LDL-C level < 100 mg/dL despite treatment with maximum doses of statins with or without ezetimibe.^16,17

PCSK9 inhibitors (PCSK9i) have robust efficacy data to support use in patients who do not meet their LDL-C goal despite maximally tolerated lipid therapy.¹⁴ However, long-term safety data for PCSK9i are not as robust as its efficacy data. Specifically, safety data relating to muscle-related AEs, which are the most widely recognized AE associated with statins, have only been reported in a few clinical trials with varying incidence rates, levels of significance, and relatively small study populations. Furthermore, the real-world prevalence of muscle-related PCSK9i AEs is unknown. Clinical guidance for management strategies for muscle-related AEs associated with PCSK9i is largely lacking. For this study, muscle-related AEs were defined as any new or unusual muscle soreness, weakness, cramping, aches, and stiffness that persists, is generally bilateral, and typically affects the large muscles. It is important to note, that muscle-related AEs associated with statins, ezetimibe, and PCSK9i can be attributed to the nocebo effect.

According to the prescribing information for alirocumab and evolocumab, myalgia, muscle spasms, and musculoskeletal pain each occurred in < 5% of the study populations.^18,19 From these data, muscle-related PCSK9i AEs are thought to be relatively rare, based on the ODYSSEY-OUTCOME and FOURIER trials, which did not enroll statin-intolerant patients.^20,21 However, currently available safety data from 3 small, randomized clinical trials specifically in statin-intolerant patients taking a PCSK9i suggest that muscle-related AEs occur at a rate of 12.2% to 32.5% and discontinuation rates varied from 0% to 15.9%.^22-25 As the incidence rates of muscle-related AEs in the prescribing information and clinical trials varied widely, this study will provide quantitative data on the percentage of patients that developed muscle-related PCSK9i AEs in a veteran population to help shed light on a topic that is not well studied.

Methods

This was a single-center, retrospective chart review of patients prescribed a PCSK9i between December 1, 2017, and September 1, 2021, and were managed in a pharmacy-led patient aligned care team (PACT) clinic at the Wilkes-Barre US Department of Veterans Affairs (VA) Medical Center (WBVAMC) in Pennsylvania. This study was approved by the Coatesville VA Medical Center Institutional Review Board, which oversees research conducted at WBVAMC. Veterans aged ≥ 18 years were included in the study. Patients were excluded if they had a history of serious hypersensitivity reaction to a PCSK9i or rhabdomyolysis or did not meet the VA criteria for use.²⁶

The primary outcome was the percentage of patients who developed a muscle-related AE while on a PCSK9i in a PACT clinic. Data were further analyzed based on patients who (1) tolerated a full PCSK9i dose; (2) tolerated alternative PCSK9i following initial intolerance; (3) required a PCSK9i dose reduction, or (4) discontinued PCSK9i. A secondary outcome was the percentage of statin- and/or ezetimibe-intolerant patients in these 4 groups. Another secondary outcome was the management strategies taken for patients who were on a reduced (monthly) dose of PCSK9i who did not reach their LDL-C goal. Management strategies that were assessed included restarting weekly statin, restarting weekly ezetimibe, increasing the dose of the same PCSK9i administered monthly, and switching to an alternative PCSK9i.

Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a secure, locked spreadsheet. Baseline patient demographic characteristics collected included age (at PCSK9i start); sex; race; and PCSK9i name, dose, and frequency. We recorded when a patient switched PCSK9i, whether or not it was due to a muscle-related AE, and the name of the original PCSK9i. Also collected were lipid therapy intolerances prior to PCSK9i initiation (ie, intolerance to statin, ezetimibe, or both).

Patients were considered statin intolerant due to a muscle-related AE in accordance with the VA PCSK9i Criteria for Use, which requires trial of at least 3 statins, one of which was trialed at the lowest dosage approved by the US Food and Drug Administration (FDA) and resulted in intolerable skeletal muscle AEs that worsened during treatment and resolved when the statin was stopped. For our study purposes, patients taking alternative day dosing of statins due to muscle-related AEs (ie, 2- or 3-times weekly dosing) were not considered statin intolerant; however, patients taking once-weekly statin dosing were considered statin intolerant. Patients were considered ezetimibe intolerant due to a muscle-related AE if the intolerance was due to skeletal muscle concerns that worsened during treatment and resolved when ezetimibe was stopped. Patients were considered PCSK9i intolerant due to a muscle-related AE if the intolerance was due to skeletal muscle concerns that worsened during treatment and resolved when the PCSK9i was stopped. Patients with non–muscle-related intolerances to statins, ezetimibe, and PCSK9i were not considered statin, ezetimibe, and PCSK9i intolerant.

Alirocumab was initiated at 75 mg subcutaneous (SQ) once every 2 weeks or evolocumab 140 mg SQ once every 2 weeks in our study. The protocol allowed for a dose reduction of alirocumab 75 mg SQ once monthly if a patient experienced AEs, but this dose reduction strategy was not used for any patients on evolocumab in this study. Of note, alirocumab 75 mg SQ once monthly is not an FDA-approved dosing strategy. However, it is similar in concept to the alternative statin dosing (ie, alternate day dosing, once-weekly dosing) and may avoid the need to discontinue PCSK9i therapy altogether.

A review of the CPRS also documented whether a muscle-related AE occurred while the patient was on a PCSK9i (if yes, the specific AE was recorded), the result of PCSK9i therapy (tolerated full dose, required a dose reduction, switched medication, or discontinued), and management strategies taken for patients who did not meet their LDL-C goal while on a reduced (monthly) PCSK9i dose. Prior lipid therapy intolerances, PCSK9i-related AEs, results of PCSK9i therapy, and management strategies for patients who did not meet LDL-C goal while on a reduced PCSK9i dose were obtained by reviewing the PACT pharmacist’s clinic notes and assessment, along with clinic notes and medication history listed within the CPRS.

Statistical Analysis

Descriptive statistics were used for the demographic characteristics of study patients. The primary outcome was calculated as a binary measure (yes/no) of whether the patient developed a muscle-related AE while on a PCSK9i. The secondary outcome of statin, ezetimibe, or statin and ezetimibe intolerances in subgroups also was calculated as a binary measure.

Results

For the study, 156 charts were reviewed and 137 patients were included (Figure).

For the secondary results, 4 patients (2.9%) tolerated an alternate PCSK9i (evolocumab 140 mg SQ every 2 weeks) after initial intolerance to PCSK9i, 16 (11.7%) required a dose reduction, and 6 (4.4%) discontinued PCSK9i due to a muscle-related AE.

Discussion

This retrospective study found 17.5% of patients experienced muscle-related PCSK9i AEs. These occurred at a higher rate than reported in the prescribing information (< 5%) and were similar to the incidence rates reported in the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE clinical trials (12.0%-32.5%), which is what we hypothesized.^18,19,22-25 It is important to note that the incidence rates of muscle-related AEs reported in the prescribing information for alirocumab and evolocumab were based on trials that did not include statin- and/or ezetimibe-intolerant patients; whereas many patients in our study and patients in the clinical trials were statin and/or ezetimibe intolerant.

Additionally, a new study by Donald and colleagues found an incidence rate of 32% to 36% for muscle-related PCSK9i AEs.²⁷ Collectively, the data from clinical trials and our study indicate that patients with prior intolerances to statin and/or ezetimibe appear to have a higher likelihood of developing a muscle-related PCSK9i intolerance. In our study, 23 of 24 patients who developed a muscle-related PCSK9i AE had a prior history of statin and/or ezetimibe intolerances. This should alert clinicians prescribing PCSK9i in patients with a history of statin and/or ezetimibe intolerance to counsel their patients on the possibility of muscle-related PCSK9i AEs and management strategies. However, it is important to note that there was a substantial number of patients in our study who were statin and/or ezetimibe intolerant due to a prior muscle-related AE who tolerated the full dose of PCSK9i.

To our knowledge, this was the first trial to evaluate muscle-related PCSK9i AEs in a veteran population. Additionally, our study appears to be the first to use 2 PCSK9i dosing strategies that are not FDA approved: Dose reduction for patients who experienced a muscle-related AE on alirocumab 75 mg SQ every 2 weeks and dose escalation for patients who did not meet their LDL-C goal on alirocumab 75 mg SQ monthly following an initial intolerance to 2-week dosing. The dose-reduction strategy allowed patients who experienced a muscle-related AE to alirocumab 75 mg to reduce administration from every 2 weeks to monthly.

This strategy was only performed with alirocumab, the preferred PCSK9i at WBVAMC, but the same dose-reduction strategy can theoretically be used with evolocumab as well. Reduced monthly dosing of alirocumab allowed patients with a prior intolerance to remain on a lower dosage without discontinuation. This is important because as noted by Myers and colleagues, individuals without access to PCSK9i were found to have a significantly higher incidence ratio of cardiovascular events compared with those taking PCSK9i.¹⁵ Also of note, > 30% of patients on the reduced monthly dose of alirocumab still met their LDL-C goal. Therefore, using this dose-reduction strategy (instead of patients discontinuing therapy altogether due to a muscle-related intolerance) can lessen the risk of major adverse cardiovascular events (MACE) as well as mitigate muscle-related AEs that occurred while on 2-week PCSK9i dosing regimens. While we acknowledge that this reduced monthly dose of either alirocumab or evolocumab is not FDA approved, it is similar to alternative statin dosing that also is not FDA approved but may minimize the need to discontinue PCSK9i therapy. It would be beneficial if these dosing strategies were investigated by future research.

The dose-escalation strategy for patients who did not meet their LDL-C goal while on the reduced, monthly dose of alirocumab also was unique. Alirocumab was increased from 75 mg SQ once monthly to 150 mg SQ once monthly. Interestingly, we found that through the end of the chart review period, all patients tolerated the increase well, despite having an initial muscle-related AE to alirocumab 75 mg every 2 weeks, which is the same total monthly dosage. This approach is similar to that of once-weekly statin dosing or a drug holiday and may be explained by the long half-life of PCSK9i. Regardless of the mechanism, this finding suggests that an increased monthly dose of PCSK9i is a potential alternative for patients who cannot tolerate the FDA-approved dose. However, the ability for patients to achieve goal LDL-C on the monthly dosage requires future study.

Limitations

The results of this study should be considered with the following limitations. First, this was a retrospective chart review performed over a prespecified period. Any muscle-related AEs or LDL-C lowering effects from PCSK9i that occurred outside the review period were not captured. Our study was small and only included 137 patients, though it was similar in size to the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE trials.^22-24 Additionally, the study was primarily composed of White men and may not be representative of other populations. Some muscle-related PCSK9i AEs may be attributed to the nocebo. Last, our study did not capture patients on a PCSK9i who were not followed in the PACT clinic.

Conclusions

We found that muscle-related PCSK9i AEs occurred at a similar rate as those reported in previous clinical trials and exceeded the incidence rate reported in the prescribing information for alirocumab and evolocumab. It appears that patients who have a prior muscle-related intolerance to a statin and/or ezetimibe had a higher likelihood of developing a muscle-related PCSK9i AE. In our study, only 1 patient developed a muscle-related PCSK9i AE who did not have a prior history of muscle-related intolerance to either a statin or ezetimibe. However, in our study, a substantial percentage of patients with statin and/or ezetimibe intolerances tolerated the full PCSK9i dose well, proving that PCSK9i are still a reasonable alternative for patients with prior intolerances to statins and/or ezetimibe.

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the US Department of Veterans Affairs Medical Center, Wilkes-Barre, Pennsylvania.

Growing up I can remember my father telling stories of service members in the medical battalion he commanded in World War II (WWII) who after the war with his encouragement and their GI Bill educational benefits went to school to become doctors, nurses, and dentists. They were among the 2,300,000 veterans who attended US colleges and universities through the Servicemen’s Readjustment Act passed in 1944. The American Legion navigated the bill through the twists and turns of congressional support, and it was one of their leaders who invented the catchy GI Bill shorthand.²

As with most political legislation, there were mixed motives driving passage of the act, and like many policies in America, the primary impetus was economic. While the war was raging overseas, at home the US Department of Labor predicted that by the war’s end, 16 million service members would be jobless. Apprehensive about the prospect of yet another financial depression, in 1943 a White House agency recommended that the federal government fund education and training for the individuals who had served during the war.²

While troops stormed the beaches of Normandy, wartime President Franklin D. Roosevelt (FDR) signed the bill that delivered not only educational and training opportunities for service members and veterans, but also funded home loans and US Department of Veterans Affairs (VA) hospitals. The bill was practical in that it provided not only tuition, but also books, supplies, a living stipend, and counseling for the students. The bill technically expired in 1956, but a series of extensions and expansions has been true to the original intention to offer those who served their nation in the military a better life as citizens.

Articles describing the impact of the GI Bill use terms like life changing and transformative.^3,4 Our contemporary culture makes it difficult to imagine how out of reach a college education was for the generation that fought WWII. Universities were primarily for the rich and connected, the powerful and privileged. Were it not for the upward social mobility the GI Bill propelled, the American dream would not have become a reality for many farmers, small town merchants, and factory workers. The GI Bill though could not by itself ensure equity. The systemic racism endemic in the United States and among the elected representatives who debated the bill resulted in many Black service members especially in the South being denied entrance to institutions of higher learning.⁵ Despite this invidious discrimination, the bill was a profound effort to help many other service members to successfully reintegrate into the society they had preserved and defended.⁴

“With the signing of this bill, a well-rounded program of special veterans’ benefits is nearly completed,” FDR said, capturing its noble intent: “It gives emphatic notice to the men and women in our armed forces that the American people do not intend to let them down.”⁶

Regrettably, we have not kept FDR’s pledge. Now unscrupulous businesses are preying on the aspirations of military personnel and veterans for an education and thwarting their ability to seek gainful employment. For more than a decade, respected news media have reported that for-profit universities were exploiting service members trying to improve their lives through obtaining a college education via the GI Bill.⁷ The sad irony is that what enabled the exploitation to occur was a major expansion of the benefits under the Post-9/11 GI Bill. This version granted educational funding to any individual who had served on active duty for 90 days or more after September 10, 2001.⁸ Federal law prohibits for-profit educational institutions from receiving more than 90% of their total revenue from federal student aid. A loophole in the law enabled these institutions to categorize GI Bill funding as private not government dollars. Bad old American greed drove these for-profit colleges and universities to aggressively recruit veterans who trusted in the good faith of the academic institutions. Once the GI Bill monies were exhausted, veterans had already invested so much time and energy in a degree or certificate, the schools could persuade them to take out student loans with the promise of job placement assistance that never materialized. They took advantage of the veterans’ hopes to fatten their own bottom line in the face of declining enrolments.⁹ Journalists, government, think tank reports, and even a documentary described the tragic stories of service members left unemployed with immense debt and degrees that to many of them were now worthless.¹⁰

After years of reporters exposing the scam and politically thwarted efforts to stop it, Congress and President Biden closed what was known as the 90/10 loophole. This ended the weaponization of education it had promoted. In October 2022, the US Department of Education announced its final rule to prohibit the widespread educational fraud that had betrayed so many veterans and service members, which Secretary Dennis McDonough described as “abuse.”¹¹Some readers may wonder why I have devoted an editorial to a topic that seems somewhat distant from the health care that is the primary domain of Federal Practitioner. It happens that education is in closer proximity to health for our patients than many of us might have realized. A 2018 Military Medicine study found that veterans who took advantage of the educational opportunities of the GI Bill had better health and reduced smoking, among other benefits.¹² This connection between health and education should serve as a source of pride for all of us in federal practice as we are part of organizations that affirm the holistic concept of health that embraces not just medicine but education, housing, and other services essential for comprehensive well-being.

Growing up I can remember my father telling stories of service members in the medical battalion he commanded in World War II (WWII) who after the war with his encouragement and their GI Bill educational benefits went to school to become doctors, nurses, and dentists. They were among the 2,300,000 veterans who attended US colleges and universities through the Servicemen’s Readjustment Act passed in 1944. The American Legion navigated the bill through the twists and turns of congressional support, and it was one of their leaders who invented the catchy GI Bill shorthand.²

As with most political legislation, there were mixed motives driving passage of the act, and like many policies in America, the primary impetus was economic. While the war was raging overseas, at home the US Department of Labor predicted that by the war’s end, 16 million service members would be jobless. Apprehensive about the prospect of yet another financial depression, in 1943 a White House agency recommended that the federal government fund education and training for the individuals who had served during the war.²

While troops stormed the beaches of Normandy, wartime President Franklin D. Roosevelt (FDR) signed the bill that delivered not only educational and training opportunities for service members and veterans, but also funded home loans and US Department of Veterans Affairs (VA) hospitals. The bill was practical in that it provided not only tuition, but also books, supplies, a living stipend, and counseling for the students. The bill technically expired in 1956, but a series of extensions and expansions has been true to the original intention to offer those who served their nation in the military a better life as citizens.

Articles describing the impact of the GI Bill use terms like life changing and transformative.^3,4 Our contemporary culture makes it difficult to imagine how out of reach a college education was for the generation that fought WWII. Universities were primarily for the rich and connected, the powerful and privileged. Were it not for the upward social mobility the GI Bill propelled, the American dream would not have become a reality for many farmers, small town merchants, and factory workers. The GI Bill though could not by itself ensure equity. The systemic racism endemic in the United States and among the elected representatives who debated the bill resulted in many Black service members especially in the South being denied entrance to institutions of higher learning.⁵ Despite this invidious discrimination, the bill was a profound effort to help many other service members to successfully reintegrate into the society they had preserved and defended.⁴

“With the signing of this bill, a well-rounded program of special veterans’ benefits is nearly completed,” FDR said, capturing its noble intent: “It gives emphatic notice to the men and women in our armed forces that the American people do not intend to let them down.”⁶

Regrettably, we have not kept FDR’s pledge. Now unscrupulous businesses are preying on the aspirations of military personnel and veterans for an education and thwarting their ability to seek gainful employment. For more than a decade, respected news media have reported that for-profit universities were exploiting service members trying to improve their lives through obtaining a college education via the GI Bill.⁷ The sad irony is that what enabled the exploitation to occur was a major expansion of the benefits under the Post-9/11 GI Bill. This version granted educational funding to any individual who had served on active duty for 90 days or more after September 10, 2001.⁸ Federal law prohibits for-profit educational institutions from receiving more than 90% of their total revenue from federal student aid. A loophole in the law enabled these institutions to categorize GI Bill funding as private not government dollars. Bad old American greed drove these for-profit colleges and universities to aggressively recruit veterans who trusted in the good faith of the academic institutions. Once the GI Bill monies were exhausted, veterans had already invested so much time and energy in a degree or certificate, the schools could persuade them to take out student loans with the promise of job placement assistance that never materialized. They took advantage of the veterans’ hopes to fatten their own bottom line in the face of declining enrolments.⁹ Journalists, government, think tank reports, and even a documentary described the tragic stories of service members left unemployed with immense debt and degrees that to many of them were now worthless.¹⁰

After years of reporters exposing the scam and politically thwarted efforts to stop it, Congress and President Biden closed what was known as the 90/10 loophole. This ended the weaponization of education it had promoted. In October 2022, the US Department of Education announced its final rule to prohibit the widespread educational fraud that had betrayed so many veterans and service members, which Secretary Dennis McDonough described as “abuse.”¹¹Some readers may wonder why I have devoted an editorial to a topic that seems somewhat distant from the health care that is the primary domain of Federal Practitioner. It happens that education is in closer proximity to health for our patients than many of us might have realized. A 2018 Military Medicine study found that veterans who took advantage of the educational opportunities of the GI Bill had better health and reduced smoking, among other benefits.¹² This connection between health and education should serve as a source of pride for all of us in federal practice as we are part of organizations that affirm the holistic concept of health that embraces not just medicine but education, housing, and other services essential for comprehensive well-being.

Growing up I can remember my father telling stories of service members in the medical battalion he commanded in World War II (WWII) who after the war with his encouragement and their GI Bill educational benefits went to school to become doctors, nurses, and dentists. They were among the 2,300,000 veterans who attended US colleges and universities through the Servicemen’s Readjustment Act passed in 1944. The American Legion navigated the bill through the twists and turns of congressional support, and it was one of their leaders who invented the catchy GI Bill shorthand.²

As with most political legislation, there were mixed motives driving passage of the act, and like many policies in America, the primary impetus was economic. While the war was raging overseas, at home the US Department of Labor predicted that by the war’s end, 16 million service members would be jobless. Apprehensive about the prospect of yet another financial depression, in 1943 a White House agency recommended that the federal government fund education and training for the individuals who had served during the war.²

While troops stormed the beaches of Normandy, wartime President Franklin D. Roosevelt (FDR) signed the bill that delivered not only educational and training opportunities for service members and veterans, but also funded home loans and US Department of Veterans Affairs (VA) hospitals. The bill was practical in that it provided not only tuition, but also books, supplies, a living stipend, and counseling for the students. The bill technically expired in 1956, but a series of extensions and expansions has been true to the original intention to offer those who served their nation in the military a better life as citizens.

Articles describing the impact of the GI Bill use terms like life changing and transformative.^3,4 Our contemporary culture makes it difficult to imagine how out of reach a college education was for the generation that fought WWII. Universities were primarily for the rich and connected, the powerful and privileged. Were it not for the upward social mobility the GI Bill propelled, the American dream would not have become a reality for many farmers, small town merchants, and factory workers. The GI Bill though could not by itself ensure equity. The systemic racism endemic in the United States and among the elected representatives who debated the bill resulted in many Black service members especially in the South being denied entrance to institutions of higher learning.⁵ Despite this invidious discrimination, the bill was a profound effort to help many other service members to successfully reintegrate into the society they had preserved and defended.⁴

“With the signing of this bill, a well-rounded program of special veterans’ benefits is nearly completed,” FDR said, capturing its noble intent: “It gives emphatic notice to the men and women in our armed forces that the American people do not intend to let them down.”⁶

Regrettably, we have not kept FDR’s pledge. Now unscrupulous businesses are preying on the aspirations of military personnel and veterans for an education and thwarting their ability to seek gainful employment. For more than a decade, respected news media have reported that for-profit universities were exploiting service members trying to improve their lives through obtaining a college education via the GI Bill.⁷ The sad irony is that what enabled the exploitation to occur was a major expansion of the benefits under the Post-9/11 GI Bill. This version granted educational funding to any individual who had served on active duty for 90 days or more after September 10, 2001.⁸ Federal law prohibits for-profit educational institutions from receiving more than 90% of their total revenue from federal student aid. A loophole in the law enabled these institutions to categorize GI Bill funding as private not government dollars. Bad old American greed drove these for-profit colleges and universities to aggressively recruit veterans who trusted in the good faith of the academic institutions. Once the GI Bill monies were exhausted, veterans had already invested so much time and energy in a degree or certificate, the schools could persuade them to take out student loans with the promise of job placement assistance that never materialized. They took advantage of the veterans’ hopes to fatten their own bottom line in the face of declining enrolments.⁹ Journalists, government, think tank reports, and even a documentary described the tragic stories of service members left unemployed with immense debt and degrees that to many of them were now worthless.¹⁰

After years of reporters exposing the scam and politically thwarted efforts to stop it, Congress and President Biden closed what was known as the 90/10 loophole. This ended the weaponization of education it had promoted. In October 2022, the US Department of Education announced its final rule to prohibit the widespread educational fraud that had betrayed so many veterans and service members, which Secretary Dennis McDonough described as “abuse.”¹¹Some readers may wonder why I have devoted an editorial to a topic that seems somewhat distant from the health care that is the primary domain of Federal Practitioner. It happens that education is in closer proximity to health for our patients than many of us might have realized. A 2018 Military Medicine study found that veterans who took advantage of the educational opportunities of the GI Bill had better health and reduced smoking, among other benefits.¹² This connection between health and education should serve as a source of pride for all of us in federal practice as we are part of organizations that affirm the holistic concept of health that embraces not just medicine but education, housing, and other services essential for comprehensive well-being.

Veterans who interact with the criminal justice system (ie, justice-involved veterans) have heightened rates of mental health and psychosocial needs, including posttraumatic stress disorder (PTSD), substance use disorder, depression, suicidal ideation and attempt, and homelessness.^1,2 Alongside these criminogenic risk factors, recidivism is common among justice-involved veterans: About 70% of incarcerated veterans disclosed at least one prior incarceration.³

To address the complex interplay of psychosocial factors, mental health concerns, and justice involvement among veterans, veterans treatment courts (VTCs) emerged as an alternative to incarceration.⁴ VTC participation often consists of integrated treatment and rehabilitative services (eg, vocational training, health care), ongoing monitoring for substance use, graduated responses to address treatment adherence, and ongoing communication with the judge and legal counsel.⁴

A primary aim of these courts is to address psychosocial needs believed to underlie criminal behavior, thus reducing risk of recidivism and promoting successful recovery and community integration for eligible veterans. To do so, VTCs collaborate with community-based and/or US Department of Veterans Affairs services, such as the Veterans Justice Outreach program (VJO). VJO specialists identify and refer justice-involved veterans to Veterans Health Administration (VHA) and community care and serve as a liaison between VTC staff and VHA health care professionals (HCPs).⁵

VTC outcome studies highlight the importance of not only diverting veterans to problem-solving courts, but also ensuring their optimal participation. Successful graduates of VTC programs demonstrate significant improvements in mental health symptoms, life satisfaction, and social support, as well as lower rates of law enforcement interactions.^6,7 However, less is known about supporting those veterans who have difficulty engaging in VTCs and either discontinue participation or require lengthier periods of participation to meet court graduation requirements.⁸ One possibility to improve engagement among these veterans is to enhance court practices to best meet their needs.

In addition to delivering treatment, VHA mental health professionals may serve a critical interdisciplinary role by lending expertise to support VTC practices. For example, equipping court professionals with clinical knowledge and skills related to motivation may strengthen the staff’s interactions with participants, enabling them to address barriers as they arise and to facilitate veterans’ treatment adherence. Additionally, responsiveness to the impact of trauma exposure, which is common among this population, may prove important as related symptoms can affect veterans’ engagement, receptivity, and behavior in court settings. Indeed, prior examinations of justice-involved veterans have found trauma exposure rates ranging from 60% to 90% and PTSD rates ranging from 27% to 40%.^1,2 Notably, involvement with the justice system (eg, incarceration) may itself further increase risk of trauma exposure (eg, experiencing a physical or sexual assault in prison) or exacerbate existing PTSD.⁹ Nonetheless, whereas many drug courts and domestic violence courts have been established, problem-solving courts with a specialized focus on trauma exposure remain rare, suggesting a potential gap in court training.

VHA HCPs have the potential to facilitate justice-involved veterans’ successful court and treatment participation by coordinating with VJO specialists to provide training and consultation to the courts. Supporting efforts to effectively and responsively address criminogenic risk (eg, mental health) in VTC settings may in turn reduce the likelihood of recidivism.¹⁰ Given the elevated rates of trauma exposure among justice-involved veterans and the relative lack of trauma-focused VTCs, we developed a trauma-informed training for VTC professionals that centered on related clinical presentations of justice-involved veterans and frequently occurring challenges in the context of court participation.

Program Development

This educational program aimed to (1) provide psychoeducation on trauma exposure, PTSD, and existing evidence-based treatments; (2) present clinical considerations for justice-involved veterans related to trauma exposure and/or PTSD; and (3) introduce skills to facilitate effective communication and trauma-informed care practices among professionals working with veterans in a treatment court.

Prior to piloting the program, we conducted a needs assessment with VTC professionals and identified relevant theoretical constructs and brief interventions for inclusion in the training. Additionally, given the dearth of prior research on mental health education for VTCs, the team consulted with the developers of PTSD 101, a VHA workshop for veterans’ families that promotes psychoeducation, support, and effective communication.¹¹ Doing so informed approaches to delivering education to nonclinical audiences that interact with veterans with histories of trauma exposure. As this was a program development project, it was determined to be exempt from institutional review board review.

Needs Assessment

In the initial stages of development, local VJO specialists identified regional VTCs and facilitated introductions to these courts. Two of the 3 Rocky Mountain region VTCs that were contacted expressed interest in receiving trauma-informed training. Based on preliminary interest, the facilitators conducted a needs assessment with VJO and VTC staff from these 2 courts to capture requests for specific content and past experiences with other mental health trainings.

Guided by the focus group model, the needs assessments took place during three 1-hour meetings with VJO specialists and a 1-hour meeting with VJO specialists, VTC professionals, and community-based clinical partners.¹² Additionally, attending a VTC graduation and court session allowed for observations of court practices and interactions with veterans. A total of 13 professionals (judges, court coordinators, case managers, peer mentors, VJO specialists, and clinicians who specialize in substance use disorder and intimate partner violence) participated in the needs assessments.

The most critical need identified by court professionals was a focus on how to apply knowledge about trauma and PTSD to interactions with justice-involved veterans. This was reportedly absent from prior training sessions the courts had received. Both Rocky Mountain region VTCs expressed a strong interest in and openness to adapting practices based on research and practice recommendations. Additional requests that emerged included a refresher on psychoeducation related to trauma and how to address the personal impact of working with this population (eg, compassion fatigue).

Training Components

Based on the needs identified by VTC professionals and informed by consultation with the developers of PTSD 101,

Fostering court familiarity with cognitive processing therapy and prolonged exposure may bolster veteran engagement in treatment through regular reinforcement of skills and concepts introduced in therapy. This may prove particularly salient given the limited engagement with mental health treatment and elevated dropout rates from PTSD treatment among the general veteran population.^15,16

Exercises and metaphors were used to illustrate concepts in multiple ways. For example, training attendees engaged in a “stop, drop, and roll” thought exercise in which they were asked to brainstorm behavioral reactions to catching on fire. This exercise illustrated the tendency for individuals to revert to common yet unhelpful attempts at problem solving (eg, running due to panic, which would exacerbate the fire), particularly in crisis and without prior education regarding adaptive ways to respond. Attendee-generated examples, such as running, were used to demonstrate the importance of practicing and reinforcing skill development prior to a crisis, to ensure proficiency and optimal response. Additionally, in prompting consideration of one’s response tendencies, this exercise may engender empathy and understanding for veterans.

Skills training. Efforts to promote veteran engagement in court, facilitate motivation and readiness for change, and address barriers that arise (eg, distress associated with court appearances) may support successful and timely graduation. As such, skills training constituted the largest component of the training and drew from observations of court practices and the VTCs’ identified challenges. Consistent with the project’s aims and reported needs of the court, skills that target common presentations following trauma exposure (eg, avoidance, hypervigilance) were prioritized for this pilot training. Strategies included brief interventions from dialectical behavior therapy, acceptance and commitment therapy, and motivational interviewing to strengthen the support provided by staff to veterans and address their needs (Table 2).

Training attendees also participated in exercises to reiterate skills. For example, attendees completed an ambivalence matrix using an audience-identified common behavior that is difficult to change (eg, heavy alcohol use as a coping mechanism for distress).

Attendees engaged in an exercise that involved identifying unhelpful thoughts and behaviors, targets for validation, and veteran strengths from a hypothetical case vignette. This vignette involved a VTC participant who initially engaged effectively but began to demonstrate difficulty appropriately engaging in court and mental health treatment as well as challenging interactions with VTC staff (eg, raised voice during court sessions, not respecting communication boundaries).

Pilot Test

Based on scheduling parameters communicated by court coordinators, the pilot training was designed as a presentation during times reserved for court staffing meetings. To accommodate court preferences due to the COVID-19 pandemic, one 90-minute training was conducted virtually in March 2022, and the other training was conducted in person in April 2022 for 2 hours. The trainings were facilitated by 2 VHA clinical psychologists and included the judge, court coordinator, VJO specialist, peer mentors, case managers, probation/parole officers, and community-based HCPs who partner with the court (eg, social workers, psychologists). About 12 to 15 professionals attended each training session.

Feedback

Feedback was solicited from attendees via an anonymous online survey. Seven participants completed the survey; the response rate of about 20% was consistent with those observed for other surveys of court professionals.²⁰ Many attendees also provided feedback directly to the facilitators. Feedback highlighted that the skills-based components not only were perceived as most helpful but also notably distinguished this training. “What set this training apart from other training events was the practical applications,” one attendee noted. “It was not just information or education, both instructors did an incredible job of explaining exactly how we could apply the knowledge they were sharing. They did this in such a way that it was easy to understand and apply.”

Specific skills were consistently identified as helpful, including managing intense emotions, addressing ambivalence, and approaching sanctions and rewards. Additionally, employing a less formal approach to the training, with relatable overviews of concepts and immediate responsiveness to requests for expansion on a topic, was perceived as a unique benefit: Another attendee appreciated that “It was beneficial to sit around a table with a less formal presentation and be able to ask questions.” This approach seemed particularly well suited for the program’s cross-disciplinary audience. Attendees reported that they valued the relatively limited focus on DSM-5 criteria. Attendees emphasized that education specific to veterans on evidence-based PTSD treatments, psychoeducation, and avoidance was very helpful. Respondents also recommended that the training be lengthened to a daylong workshop to accommodate greater opportunity to practice skills and consultation.

The consultation portion of the training provided insight into additional areas of importance to incorporate into future iterations. Identified needs included appropriate and realistic boundary setting (eg, addressing disruptions in the courtroom), suggestions for improving and expanding homework assigned by the court, and ways to address concerns about PTSD treatment shared by veterans in court (eg, attributing substance use relapses to the intensiveness of trauma-focused treatment vs lack of familiarity with alternate coping skills). Additionally, the VTC professionals’ desire to support mental health professionals’ work with veterans was clearly evident, highlighting the bidirectional value of interdisciplinary collaboration between VHA mental health professionals and VTC professionals.

Discussion

A trauma-informed training was developed and delivered to 2 VTCs in the Rocky Mountain region with the goal of providing relevant psychoeducation and introducing skills to bolster court practices that address veteran needs. Psychoeducational components of the training that were particularly well received and prompted significant participant engagement included discussions and examples of avoidance, levels of validation, language to facilitate motivation and address barriers, mechanisms underlying treatment, and potential functions underlying limited veteran treatment engagement. Distress tolerance, approaches to sanctions and rewards, and use of ambivalence matrices to guide motivation were identified as particularly helpful skills.

The pilot phase of this trauma-informed training provided valuable insights into developing mental health trainings for VTCs. Specifically, VTCs may benefit from the expertise of VHA HCPs and are particularly interested in learning brief skills to improve their practices. The usefulness of such trainings may be bolstered by efforts to form relationships with the court to identify their perceived needs and employing an iterative process that is responsive to feedback both during and after the training. Last, each stage of this project was strengthened by collaboration with VJO specialists, highlighting the importance of future collaboration between VJO and VHA mental health clinics to further support justice-involved veterans. For example, VJO specialists were instrumental in identifying training needs related to veterans’ clinical presentations in court, facilitating introductions to local VTCs, and helping to address barriers to piloting, like scheduling.

Modifications and Future Directions

The insights gained through the process of training design, delivery, and feedback inform future development of this training. Based on the feedback received, subsequent versions of the training may be expanded into a half- or full-day workshop to allow for adequate time for skills training and feedback, as well as consultation. Doing so will enable facilitators to further foster attendees’ familiarity with and confidence in their ability to use these skills. Furthermore, the consultation portion of this training revealed areas that may benefit from greater attention, including how to address challenging interactions in court (eg, addressing gender dynamics between court professionals and participants) and better support veterans who are having difficulty engaging in mental health treatment (eg, courts’ observation of high rates of dropout around the third or fourth session of evidence-based treatment for PTSD). Last, all attendees who responded to the survey expressed interest in a brief resource guide based on the training, emphasizing the need for ready access to key skills and concepts to support the use of strategies learned.

An additional future aim of this project is to conduct a more thorough evaluation of the needs and outcomes related to this trauma-informed training for VTC professionals. With the rapid growth of VTCs nationwide, relatively little examination of court processes and practices has occurred, and there is a lack of research on the development or effectiveness of mental health trainings provided to VTCs.²¹ Therefore, we intend to conduct larger scale qualitative interviews with court personnel and VJO specialists to obtain a clearer understanding of the needs related to skills-based training and gaps in psychoeducation. These comprehensive needs assessments may also capture common comorbidities that were not incorporated into the pilot training (eg, substance use disorders) but may be important training targets for court professionals. This information will be used to inform subsequent expansion and adaptation of the training into a longer workshop. Program evaluation will be conducted via survey-based feedback on perceived usefulness of the workshop and self-report of confidence in and use of strategies to improve court practices. Furthermore, efforts to obtain veteran outcome data, such as treatment engagement and successful participation in VTC, may be pursued.

Limitations

This training development and pilot project provided valuable foundational information regarding a largely unexamined component of treatment courts—the benefit of skills-based trainings to facilitate court practices related to justice-involved veterans. However, it is worth noting that survey responses were limited; thus, the feedback received may not reflect all attendees’ perceptions. Additionally, because both training sessions were conducted solely with 2 courts in the Rocky Mountain area, feedback may be limited to the needs of this geographic region.

Conclusions

A trauma-informed training was developed for VTCs to facilitate relevant understanding of justice-involved veterans’ needs and presentations in court, introduce skills to address challenges that arise (eg, motivation, emotional dysregulation), and provide interdisciplinary support to court professionals. This training was an important step toward fostering strong collaborations between VHA HCPs and community-based veterans courts, and feedback received during development and following implementation highlighted the perceived need for a skills-based approach to such trainings. Further program development and evaluation can strengthen this training and provide a foundation for dissemination to a broader scope of VTCs, with the goal of reducing recidivism risk among justice-involved veterans by promoting effective engagement in problem-solving court.

Veterans who interact with the criminal justice system (ie, justice-involved veterans) have heightened rates of mental health and psychosocial needs, including posttraumatic stress disorder (PTSD), substance use disorder, depression, suicidal ideation and attempt, and homelessness.^1,2 Alongside these criminogenic risk factors, recidivism is common among justice-involved veterans: About 70% of incarcerated veterans disclosed at least one prior incarceration.³

To address the complex interplay of psychosocial factors, mental health concerns, and justice involvement among veterans, veterans treatment courts (VTCs) emerged as an alternative to incarceration.⁴ VTC participation often consists of integrated treatment and rehabilitative services (eg, vocational training, health care), ongoing monitoring for substance use, graduated responses to address treatment adherence, and ongoing communication with the judge and legal counsel.⁴

A primary aim of these courts is to address psychosocial needs believed to underlie criminal behavior, thus reducing risk of recidivism and promoting successful recovery and community integration for eligible veterans. To do so, VTCs collaborate with community-based and/or US Department of Veterans Affairs services, such as the Veterans Justice Outreach program (VJO). VJO specialists identify and refer justice-involved veterans to Veterans Health Administration (VHA) and community care and serve as a liaison between VTC staff and VHA health care professionals (HCPs).⁵

VTC outcome studies highlight the importance of not only diverting veterans to problem-solving courts, but also ensuring their optimal participation. Successful graduates of VTC programs demonstrate significant improvements in mental health symptoms, life satisfaction, and social support, as well as lower rates of law enforcement interactions.^6,7 However, less is known about supporting those veterans who have difficulty engaging in VTCs and either discontinue participation or require lengthier periods of participation to meet court graduation requirements.⁸ One possibility to improve engagement among these veterans is to enhance court practices to best meet their needs.

In addition to delivering treatment, VHA mental health professionals may serve a critical interdisciplinary role by lending expertise to support VTC practices. For example, equipping court professionals with clinical knowledge and skills related to motivation may strengthen the staff’s interactions with participants, enabling them to address barriers as they arise and to facilitate veterans’ treatment adherence. Additionally, responsiveness to the impact of trauma exposure, which is common among this population, may prove important as related symptoms can affect veterans’ engagement, receptivity, and behavior in court settings. Indeed, prior examinations of justice-involved veterans have found trauma exposure rates ranging from 60% to 90% and PTSD rates ranging from 27% to 40%.^1,2 Notably, involvement with the justice system (eg, incarceration) may itself further increase risk of trauma exposure (eg, experiencing a physical or sexual assault in prison) or exacerbate existing PTSD.⁹ Nonetheless, whereas many drug courts and domestic violence courts have been established, problem-solving courts with a specialized focus on trauma exposure remain rare, suggesting a potential gap in court training.

VHA HCPs have the potential to facilitate justice-involved veterans’ successful court and treatment participation by coordinating with VJO specialists to provide training and consultation to the courts. Supporting efforts to effectively and responsively address criminogenic risk (eg, mental health) in VTC settings may in turn reduce the likelihood of recidivism.¹⁰ Given the elevated rates of trauma exposure among justice-involved veterans and the relative lack of trauma-focused VTCs, we developed a trauma-informed training for VTC professionals that centered on related clinical presentations of justice-involved veterans and frequently occurring challenges in the context of court participation.

Program Development

This educational program aimed to (1) provide psychoeducation on trauma exposure, PTSD, and existing evidence-based treatments; (2) present clinical considerations for justice-involved veterans related to trauma exposure and/or PTSD; and (3) introduce skills to facilitate effective communication and trauma-informed care practices among professionals working with veterans in a treatment court.

Prior to piloting the program, we conducted a needs assessment with VTC professionals and identified relevant theoretical constructs and brief interventions for inclusion in the training. Additionally, given the dearth of prior research on mental health education for VTCs, the team consulted with the developers of PTSD 101, a VHA workshop for veterans’ families that promotes psychoeducation, support, and effective communication.¹¹ Doing so informed approaches to delivering education to nonclinical audiences that interact with veterans with histories of trauma exposure. As this was a program development project, it was determined to be exempt from institutional review board review.

Needs Assessment

In the initial stages of development, local VJO specialists identified regional VTCs and facilitated introductions to these courts. Two of the 3 Rocky Mountain region VTCs that were contacted expressed interest in receiving trauma-informed training. Based on preliminary interest, the facilitators conducted a needs assessment with VJO and VTC staff from these 2 courts to capture requests for specific content and past experiences with other mental health trainings.

Guided by the focus group model, the needs assessments took place during three 1-hour meetings with VJO specialists and a 1-hour meeting with VJO specialists, VTC professionals, and community-based clinical partners.¹² Additionally, attending a VTC graduation and court session allowed for observations of court practices and interactions with veterans. A total of 13 professionals (judges, court coordinators, case managers, peer mentors, VJO specialists, and clinicians who specialize in substance use disorder and intimate partner violence) participated in the needs assessments.

The most critical need identified by court professionals was a focus on how to apply knowledge about trauma and PTSD to interactions with justice-involved veterans. This was reportedly absent from prior training sessions the courts had received. Both Rocky Mountain region VTCs expressed a strong interest in and openness to adapting practices based on research and practice recommendations. Additional requests that emerged included a refresher on psychoeducation related to trauma and how to address the personal impact of working with this population (eg, compassion fatigue).

Training Components

Based on the needs identified by VTC professionals and informed by consultation with the developers of PTSD 101,

Fostering court familiarity with cognitive processing therapy and prolonged exposure may bolster veteran engagement in treatment through regular reinforcement of skills and concepts introduced in therapy. This may prove particularly salient given the limited engagement with mental health treatment and elevated dropout rates from PTSD treatment among the general veteran population.^15,16

Exercises and metaphors were used to illustrate concepts in multiple ways. For example, training attendees engaged in a “stop, drop, and roll” thought exercise in which they were asked to brainstorm behavioral reactions to catching on fire. This exercise illustrated the tendency for individuals to revert to common yet unhelpful attempts at problem solving (eg, running due to panic, which would exacerbate the fire), particularly in crisis and without prior education regarding adaptive ways to respond. Attendee-generated examples, such as running, were used to demonstrate the importance of practicing and reinforcing skill development prior to a crisis, to ensure proficiency and optimal response. Additionally, in prompting consideration of one’s response tendencies, this exercise may engender empathy and understanding for veterans.

Skills training. Efforts to promote veteran engagement in court, facilitate motivation and readiness for change, and address barriers that arise (eg, distress associated with court appearances) may support successful and timely graduation. As such, skills training constituted the largest component of the training and drew from observations of court practices and the VTCs’ identified challenges. Consistent with the project’s aims and reported needs of the court, skills that target common presentations following trauma exposure (eg, avoidance, hypervigilance) were prioritized for this pilot training. Strategies included brief interventions from dialectical behavior therapy, acceptance and commitment therapy, and motivational interviewing to strengthen the support provided by staff to veterans and address their needs (Table 2).

Training attendees also participated in exercises to reiterate skills. For example, attendees completed an ambivalence matrix using an audience-identified common behavior that is difficult to change (eg, heavy alcohol use as a coping mechanism for distress).

Attendees engaged in an exercise that involved identifying unhelpful thoughts and behaviors, targets for validation, and veteran strengths from a hypothetical case vignette. This vignette involved a VTC participant who initially engaged effectively but began to demonstrate difficulty appropriately engaging in court and mental health treatment as well as challenging interactions with VTC staff (eg, raised voice during court sessions, not respecting communication boundaries).

Pilot Test

Based on scheduling parameters communicated by court coordinators, the pilot training was designed as a presentation during times reserved for court staffing meetings. To accommodate court preferences due to the COVID-19 pandemic, one 90-minute training was conducted virtually in March 2022, and the other training was conducted in person in April 2022 for 2 hours. The trainings were facilitated by 2 VHA clinical psychologists and included the judge, court coordinator, VJO specialist, peer mentors, case managers, probation/parole officers, and community-based HCPs who partner with the court (eg, social workers, psychologists). About 12 to 15 professionals attended each training session.

Feedback

Feedback was solicited from attendees via an anonymous online survey. Seven participants completed the survey; the response rate of about 20% was consistent with those observed for other surveys of court professionals.²⁰ Many attendees also provided feedback directly to the facilitators. Feedback highlighted that the skills-based components not only were perceived as most helpful but also notably distinguished this training. “What set this training apart from other training events was the practical applications,” one attendee noted. “It was not just information or education, both instructors did an incredible job of explaining exactly how we could apply the knowledge they were sharing. They did this in such a way that it was easy to understand and apply.”

Specific skills were consistently identified as helpful, including managing intense emotions, addressing ambivalence, and approaching sanctions and rewards. Additionally, employing a less formal approach to the training, with relatable overviews of concepts and immediate responsiveness to requests for expansion on a topic, was perceived as a unique benefit: Another attendee appreciated that “It was beneficial to sit around a table with a less formal presentation and be able to ask questions.” This approach seemed particularly well suited for the program’s cross-disciplinary audience. Attendees reported that they valued the relatively limited focus on DSM-5 criteria. Attendees emphasized that education specific to veterans on evidence-based PTSD treatments, psychoeducation, and avoidance was very helpful. Respondents also recommended that the training be lengthened to a daylong workshop to accommodate greater opportunity to practice skills and consultation.

The consultation portion of the training provided insight into additional areas of importance to incorporate into future iterations. Identified needs included appropriate and realistic boundary setting (eg, addressing disruptions in the courtroom), suggestions for improving and expanding homework assigned by the court, and ways to address concerns about PTSD treatment shared by veterans in court (eg, attributing substance use relapses to the intensiveness of trauma-focused treatment vs lack of familiarity with alternate coping skills). Additionally, the VTC professionals’ desire to support mental health professionals’ work with veterans was clearly evident, highlighting the bidirectional value of interdisciplinary collaboration between VHA mental health professionals and VTC professionals.

Discussion

A trauma-informed training was developed and delivered to 2 VTCs in the Rocky Mountain region with the goal of providing relevant psychoeducation and introducing skills to bolster court practices that address veteran needs. Psychoeducational components of the training that were particularly well received and prompted significant participant engagement included discussions and examples of avoidance, levels of validation, language to facilitate motivation and address barriers, mechanisms underlying treatment, and potential functions underlying limited veteran treatment engagement. Distress tolerance, approaches to sanctions and rewards, and use of ambivalence matrices to guide motivation were identified as particularly helpful skills.

The pilot phase of this trauma-informed training provided valuable insights into developing mental health trainings for VTCs. Specifically, VTCs may benefit from the expertise of VHA HCPs and are particularly interested in learning brief skills to improve their practices. The usefulness of such trainings may be bolstered by efforts to form relationships with the court to identify their perceived needs and employing an iterative process that is responsive to feedback both during and after the training. Last, each stage of this project was strengthened by collaboration with VJO specialists, highlighting the importance of future collaboration between VJO and VHA mental health clinics to further support justice-involved veterans. For example, VJO specialists were instrumental in identifying training needs related to veterans’ clinical presentations in court, facilitating introductions to local VTCs, and helping to address barriers to piloting, like scheduling.

Modifications and Future Directions

The insights gained through the process of training design, delivery, and feedback inform future development of this training. Based on the feedback received, subsequent versions of the training may be expanded into a half- or full-day workshop to allow for adequate time for skills training and feedback, as well as consultation. Doing so will enable facilitators to further foster attendees’ familiarity with and confidence in their ability to use these skills. Furthermore, the consultation portion of this training revealed areas that may benefit from greater attention, including how to address challenging interactions in court (eg, addressing gender dynamics between court professionals and participants) and better support veterans who are having difficulty engaging in mental health treatment (eg, courts’ observation of high rates of dropout around the third or fourth session of evidence-based treatment for PTSD). Last, all attendees who responded to the survey expressed interest in a brief resource guide based on the training, emphasizing the need for ready access to key skills and concepts to support the use of strategies learned.

An additional future aim of this project is to conduct a more thorough evaluation of the needs and outcomes related to this trauma-informed training for VTC professionals. With the rapid growth of VTCs nationwide, relatively little examination of court processes and practices has occurred, and there is a lack of research on the development or effectiveness of mental health trainings provided to VTCs.²¹ Therefore, we intend to conduct larger scale qualitative interviews with court personnel and VJO specialists to obtain a clearer understanding of the needs related to skills-based training and gaps in psychoeducation. These comprehensive needs assessments may also capture common comorbidities that were not incorporated into the pilot training (eg, substance use disorders) but may be important training targets for court professionals. This information will be used to inform subsequent expansion and adaptation of the training into a longer workshop. Program evaluation will be conducted via survey-based feedback on perceived usefulness of the workshop and self-report of confidence in and use of strategies to improve court practices. Furthermore, efforts to obtain veteran outcome data, such as treatment engagement and successful participation in VTC, may be pursued.

Limitations

This training development and pilot project provided valuable foundational information regarding a largely unexamined component of treatment courts—the benefit of skills-based trainings to facilitate court practices related to justice-involved veterans. However, it is worth noting that survey responses were limited; thus, the feedback received may not reflect all attendees’ perceptions. Additionally, because both training sessions were conducted solely with 2 courts in the Rocky Mountain area, feedback may be limited to the needs of this geographic region.

Conclusions

A trauma-informed training was developed for VTCs to facilitate relevant understanding of justice-involved veterans’ needs and presentations in court, introduce skills to address challenges that arise (eg, motivation, emotional dysregulation), and provide interdisciplinary support to court professionals. This training was an important step toward fostering strong collaborations between VHA HCPs and community-based veterans courts, and feedback received during development and following implementation highlighted the perceived need for a skills-based approach to such trainings. Further program development and evaluation can strengthen this training and provide a foundation for dissemination to a broader scope of VTCs, with the goal of reducing recidivism risk among justice-involved veterans by promoting effective engagement in problem-solving court.

Veterans who interact with the criminal justice system (ie, justice-involved veterans) have heightened rates of mental health and psychosocial needs, including posttraumatic stress disorder (PTSD), substance use disorder, depression, suicidal ideation and attempt, and homelessness.^1,2 Alongside these criminogenic risk factors, recidivism is common among justice-involved veterans: About 70% of incarcerated veterans disclosed at least one prior incarceration.³

To address the complex interplay of psychosocial factors, mental health concerns, and justice involvement among veterans, veterans treatment courts (VTCs) emerged as an alternative to incarceration.⁴ VTC participation often consists of integrated treatment and rehabilitative services (eg, vocational training, health care), ongoing monitoring for substance use, graduated responses to address treatment adherence, and ongoing communication with the judge and legal counsel.⁴

A primary aim of these courts is to address psychosocial needs believed to underlie criminal behavior, thus reducing risk of recidivism and promoting successful recovery and community integration for eligible veterans. To do so, VTCs collaborate with community-based and/or US Department of Veterans Affairs services, such as the Veterans Justice Outreach program (VJO). VJO specialists identify and refer justice-involved veterans to Veterans Health Administration (VHA) and community care and serve as a liaison between VTC staff and VHA health care professionals (HCPs).⁵

VTC outcome studies highlight the importance of not only diverting veterans to problem-solving courts, but also ensuring their optimal participation. Successful graduates of VTC programs demonstrate significant improvements in mental health symptoms, life satisfaction, and social support, as well as lower rates of law enforcement interactions.^6,7 However, less is known about supporting those veterans who have difficulty engaging in VTCs and either discontinue participation or require lengthier periods of participation to meet court graduation requirements.⁸ One possibility to improve engagement among these veterans is to enhance court practices to best meet their needs.

In addition to delivering treatment, VHA mental health professionals may serve a critical interdisciplinary role by lending expertise to support VTC practices. For example, equipping court professionals with clinical knowledge and skills related to motivation may strengthen the staff’s interactions with participants, enabling them to address barriers as they arise and to facilitate veterans’ treatment adherence. Additionally, responsiveness to the impact of trauma exposure, which is common among this population, may prove important as related symptoms can affect veterans’ engagement, receptivity, and behavior in court settings. Indeed, prior examinations of justice-involved veterans have found trauma exposure rates ranging from 60% to 90% and PTSD rates ranging from 27% to 40%.^1,2 Notably, involvement with the justice system (eg, incarceration) may itself further increase risk of trauma exposure (eg, experiencing a physical or sexual assault in prison) or exacerbate existing PTSD.⁹ Nonetheless, whereas many drug courts and domestic violence courts have been established, problem-solving courts with a specialized focus on trauma exposure remain rare, suggesting a potential gap in court training.

VHA HCPs have the potential to facilitate justice-involved veterans’ successful court and treatment participation by coordinating with VJO specialists to provide training and consultation to the courts. Supporting efforts to effectively and responsively address criminogenic risk (eg, mental health) in VTC settings may in turn reduce the likelihood of recidivism.¹⁰ Given the elevated rates of trauma exposure among justice-involved veterans and the relative lack of trauma-focused VTCs, we developed a trauma-informed training for VTC professionals that centered on related clinical presentations of justice-involved veterans and frequently occurring challenges in the context of court participation.

Program Development

This educational program aimed to (1) provide psychoeducation on trauma exposure, PTSD, and existing evidence-based treatments; (2) present clinical considerations for justice-involved veterans related to trauma exposure and/or PTSD; and (3) introduce skills to facilitate effective communication and trauma-informed care practices among professionals working with veterans in a treatment court.

Prior to piloting the program, we conducted a needs assessment with VTC professionals and identified relevant theoretical constructs and brief interventions for inclusion in the training. Additionally, given the dearth of prior research on mental health education for VTCs, the team consulted with the developers of PTSD 101, a VHA workshop for veterans’ families that promotes psychoeducation, support, and effective communication.¹¹ Doing so informed approaches to delivering education to nonclinical audiences that interact with veterans with histories of trauma exposure. As this was a program development project, it was determined to be exempt from institutional review board review.

Needs Assessment

In the initial stages of development, local VJO specialists identified regional VTCs and facilitated introductions to these courts. Two of the 3 Rocky Mountain region VTCs that were contacted expressed interest in receiving trauma-informed training. Based on preliminary interest, the facilitators conducted a needs assessment with VJO and VTC staff from these 2 courts to capture requests for specific content and past experiences with other mental health trainings.

Guided by the focus group model, the needs assessments took place during three 1-hour meetings with VJO specialists and a 1-hour meeting with VJO specialists, VTC professionals, and community-based clinical partners.¹² Additionally, attending a VTC graduation and court session allowed for observations of court practices and interactions with veterans. A total of 13 professionals (judges, court coordinators, case managers, peer mentors, VJO specialists, and clinicians who specialize in substance use disorder and intimate partner violence) participated in the needs assessments.

The most critical need identified by court professionals was a focus on how to apply knowledge about trauma and PTSD to interactions with justice-involved veterans. This was reportedly absent from prior training sessions the courts had received. Both Rocky Mountain region VTCs expressed a strong interest in and openness to adapting practices based on research and practice recommendations. Additional requests that emerged included a refresher on psychoeducation related to trauma and how to address the personal impact of working with this population (eg, compassion fatigue).

Training Components

Based on the needs identified by VTC professionals and informed by consultation with the developers of PTSD 101,

Fostering court familiarity with cognitive processing therapy and prolonged exposure may bolster veteran engagement in treatment through regular reinforcement of skills and concepts introduced in therapy. This may prove particularly salient given the limited engagement with mental health treatment and elevated dropout rates from PTSD treatment among the general veteran population.^15,16

Exercises and metaphors were used to illustrate concepts in multiple ways. For example, training attendees engaged in a “stop, drop, and roll” thought exercise in which they were asked to brainstorm behavioral reactions to catching on fire. This exercise illustrated the tendency for individuals to revert to common yet unhelpful attempts at problem solving (eg, running due to panic, which would exacerbate the fire), particularly in crisis and without prior education regarding adaptive ways to respond. Attendee-generated examples, such as running, were used to demonstrate the importance of practicing and reinforcing skill development prior to a crisis, to ensure proficiency and optimal response. Additionally, in prompting consideration of one’s response tendencies, this exercise may engender empathy and understanding for veterans.

Skills training. Efforts to promote veteran engagement in court, facilitate motivation and readiness for change, and address barriers that arise (eg, distress associated with court appearances) may support successful and timely graduation. As such, skills training constituted the largest component of the training and drew from observations of court practices and the VTCs’ identified challenges. Consistent with the project’s aims and reported needs of the court, skills that target common presentations following trauma exposure (eg, avoidance, hypervigilance) were prioritized for this pilot training. Strategies included brief interventions from dialectical behavior therapy, acceptance and commitment therapy, and motivational interviewing to strengthen the support provided by staff to veterans and address their needs (Table 2).

Training attendees also participated in exercises to reiterate skills. For example, attendees completed an ambivalence matrix using an audience-identified common behavior that is difficult to change (eg, heavy alcohol use as a coping mechanism for distress).

Attendees engaged in an exercise that involved identifying unhelpful thoughts and behaviors, targets for validation, and veteran strengths from a hypothetical case vignette. This vignette involved a VTC participant who initially engaged effectively but began to demonstrate difficulty appropriately engaging in court and mental health treatment as well as challenging interactions with VTC staff (eg, raised voice during court sessions, not respecting communication boundaries).

Pilot Test

Based on scheduling parameters communicated by court coordinators, the pilot training was designed as a presentation during times reserved for court staffing meetings. To accommodate court preferences due to the COVID-19 pandemic, one 90-minute training was conducted virtually in March 2022, and the other training was conducted in person in April 2022 for 2 hours. The trainings were facilitated by 2 VHA clinical psychologists and included the judge, court coordinator, VJO specialist, peer mentors, case managers, probation/parole officers, and community-based HCPs who partner with the court (eg, social workers, psychologists). About 12 to 15 professionals attended each training session.

Feedback

Feedback was solicited from attendees via an anonymous online survey. Seven participants completed the survey; the response rate of about 20% was consistent with those observed for other surveys of court professionals.²⁰ Many attendees also provided feedback directly to the facilitators. Feedback highlighted that the skills-based components not only were perceived as most helpful but also notably distinguished this training. “What set this training apart from other training events was the practical applications,” one attendee noted. “It was not just information or education, both instructors did an incredible job of explaining exactly how we could apply the knowledge they were sharing. They did this in such a way that it was easy to understand and apply.”

Specific skills were consistently identified as helpful, including managing intense emotions, addressing ambivalence, and approaching sanctions and rewards. Additionally, employing a less formal approach to the training, with relatable overviews of concepts and immediate responsiveness to requests for expansion on a topic, was perceived as a unique benefit: Another attendee appreciated that “It was beneficial to sit around a table with a less formal presentation and be able to ask questions.” This approach seemed particularly well suited for the program’s cross-disciplinary audience. Attendees reported that they valued the relatively limited focus on DSM-5 criteria. Attendees emphasized that education specific to veterans on evidence-based PTSD treatments, psychoeducation, and avoidance was very helpful. Respondents also recommended that the training be lengthened to a daylong workshop to accommodate greater opportunity to practice skills and consultation.

The consultation portion of the training provided insight into additional areas of importance to incorporate into future iterations. Identified needs included appropriate and realistic boundary setting (eg, addressing disruptions in the courtroom), suggestions for improving and expanding homework assigned by the court, and ways to address concerns about PTSD treatment shared by veterans in court (eg, attributing substance use relapses to the intensiveness of trauma-focused treatment vs lack of familiarity with alternate coping skills). Additionally, the VTC professionals’ desire to support mental health professionals’ work with veterans was clearly evident, highlighting the bidirectional value of interdisciplinary collaboration between VHA mental health professionals and VTC professionals.

Discussion

A trauma-informed training was developed and delivered to 2 VTCs in the Rocky Mountain region with the goal of providing relevant psychoeducation and introducing skills to bolster court practices that address veteran needs. Psychoeducational components of the training that were particularly well received and prompted significant participant engagement included discussions and examples of avoidance, levels of validation, language to facilitate motivation and address barriers, mechanisms underlying treatment, and potential functions underlying limited veteran treatment engagement. Distress tolerance, approaches to sanctions and rewards, and use of ambivalence matrices to guide motivation were identified as particularly helpful skills.

The pilot phase of this trauma-informed training provided valuable insights into developing mental health trainings for VTCs. Specifically, VTCs may benefit from the expertise of VHA HCPs and are particularly interested in learning brief skills to improve their practices. The usefulness of such trainings may be bolstered by efforts to form relationships with the court to identify their perceived needs and employing an iterative process that is responsive to feedback both during and after the training. Last, each stage of this project was strengthened by collaboration with VJO specialists, highlighting the importance of future collaboration between VJO and VHA mental health clinics to further support justice-involved veterans. For example, VJO specialists were instrumental in identifying training needs related to veterans’ clinical presentations in court, facilitating introductions to local VTCs, and helping to address barriers to piloting, like scheduling.

Modifications and Future Directions

The insights gained through the process of training design, delivery, and feedback inform future development of this training. Based on the feedback received, subsequent versions of the training may be expanded into a half- or full-day workshop to allow for adequate time for skills training and feedback, as well as consultation. Doing so will enable facilitators to further foster attendees’ familiarity with and confidence in their ability to use these skills. Furthermore, the consultation portion of this training revealed areas that may benefit from greater attention, including how to address challenging interactions in court (eg, addressing gender dynamics between court professionals and participants) and better support veterans who are having difficulty engaging in mental health treatment (eg, courts’ observation of high rates of dropout around the third or fourth session of evidence-based treatment for PTSD). Last, all attendees who responded to the survey expressed interest in a brief resource guide based on the training, emphasizing the need for ready access to key skills and concepts to support the use of strategies learned.

An additional future aim of this project is to conduct a more thorough evaluation of the needs and outcomes related to this trauma-informed training for VTC professionals. With the rapid growth of VTCs nationwide, relatively little examination of court processes and practices has occurred, and there is a lack of research on the development or effectiveness of mental health trainings provided to VTCs.²¹ Therefore, we intend to conduct larger scale qualitative interviews with court personnel and VJO specialists to obtain a clearer understanding of the needs related to skills-based training and gaps in psychoeducation. These comprehensive needs assessments may also capture common comorbidities that were not incorporated into the pilot training (eg, substance use disorders) but may be important training targets for court professionals. This information will be used to inform subsequent expansion and adaptation of the training into a longer workshop. Program evaluation will be conducted via survey-based feedback on perceived usefulness of the workshop and self-report of confidence in and use of strategies to improve court practices. Furthermore, efforts to obtain veteran outcome data, such as treatment engagement and successful participation in VTC, may be pursued.

Limitations

This training development and pilot project provided valuable foundational information regarding a largely unexamined component of treatment courts—the benefit of skills-based trainings to facilitate court practices related to justice-involved veterans. However, it is worth noting that survey responses were limited; thus, the feedback received may not reflect all attendees’ perceptions. Additionally, because both training sessions were conducted solely with 2 courts in the Rocky Mountain area, feedback may be limited to the needs of this geographic region.

Conclusions

A trauma-informed training was developed for VTCs to facilitate relevant understanding of justice-involved veterans’ needs and presentations in court, introduce skills to address challenges that arise (eg, motivation, emotional dysregulation), and provide interdisciplinary support to court professionals. This training was an important step toward fostering strong collaborations between VHA HCPs and community-based veterans courts, and feedback received during development and following implementation highlighted the perceived need for a skills-based approach to such trainings. Further program development and evaluation can strengthen this training and provide a foundation for dissemination to a broader scope of VTCs, with the goal of reducing recidivism risk among justice-involved veterans by promoting effective engagement in problem-solving court.

Aspirin is an antiplatelet agent that binds irreversibly to COX-1 and COX-2 enzymes, which results in decreased prostaglandin and thromboxane A2 production and inhibition of platelet aggregation. Aspirin often is used for its antipyretic, analgesic, and antiplatelet properties. Its use in cardiovascular disease (CVD) has been studied extensively over the past few decades, and recent data are changing the framework for aspirin use in primary prevention of atherosclerotic cardiovascular disease (ASCVD). Primary prevention refers to efforts to prevent the incidence of cardiovascular events, whereas secondary prevention refers to efforts to prevent a cardiovascular event after one has occurred.¹ This differentiation is important as it guides the course of treatment.

Three trials published in 2018 evaluated aspirin use in primary prevention of ASCVD. The ASCEND trial evaluated aspirin use for primary prevention of ASCVD in patients with diabetes mellitus (DM). This study concluded that although aspirin prevented serious vascular events in patients with DM, the benefit observed was largely counteracted by the bleeding hazard.² The ARRIVE trial evaluated aspirin use for primary prevention in patients with a moderate CVD risk. The study concluded that aspirin use in patients at moderate risk of CVD could not be assessed due to the low incidence rate of CVD; however, the study concluded that aspirin did not reduce the incidence of cardiovascular events for patients at low CVD risk and that aspirin caused more mild gastrointestinal bleeds compared with placebo.³ The ASPREE trial evaluated aspirin use for primary prevention in patients aged > 70 years to determine whether its use prolonged a healthy lifespan. This trial concluded that patients who received daily aspirin were at a higher risk of major hemorrhage and that aspirin did not diminish CVD risk compared with placebo.⁴

These studies led to a paradigm shift in therapy to reevaluate aspirin use for primary prevention. Current indications for aspirin include secondary prevention of ASCVD (ie, myocardial infarction [MI], coronary artery bypass graft, transient ischemic attack [TIA], and stroke), venous thromboembolism prophylaxis in the setting of orthopedic surgery, or valvular disease with replacement and analgesia. It is important to note that certain clinical circumstances may warrant aspirin use for primary prevention of ASCVD on a patient-specific basis, and this decision should be made using a risk/benefit analysis with the patient.

In April 2022, the US Preventive Services Task Force (USPSTF) recommended against using low-dose aspirin for primary prevention of ASCVD in individuals aged ≥ 60 years. The USPSTF noted that for patients who have a ≥ 10%, 10-year CVD risk, the decision to initiate aspirin should be based on a risk/benefit discussion and may be beneficial in certain patient populations.⁵A 2019 National Heart, Lung, and Blood Institute survey found that 29 million Americans used aspirin for primary prevention of ASCVD, and 6.6 million of these Americans used aspirin for primary prevention without the recommendation of a health care professional (HCP). Almost half of these individuals were aged > 70 years and, therefore, at an increased risk for bleeding.⁶ With the recent studies and changes in guidelines highlighting a higher risk rather than benefit with the use of aspirin for primary prevention, the current use of aspirin for primary prevention in the United States needs to be readdressed.

HCPs should assess the appropriateness of aspirin use in their patients to ensure that the risks of aspirin do not outweigh the benefits. Pharmacists can play a vital role in the assessment of aspirin for primary prevention during patient visits and make recommendations to primary care practitioners to deprescribe aspirin when appropriate.

Methods

The objective of this study was to evaluate the appropriateness of aspirin therapy in patient aligned care team (PACT) clinics at the Captain James A. Lovell Federal Health Care Center (FHCC) in North Chicago, Illinois. The PACT clinics are a category of clinics that include all the primary care clinics at FHCC.

The primary outcome of this study was to determine the percentage of patients inappropriately on aspirin therapy. To assess the inappropriate use of aspirin, relevant history of ASCVD was collected. Patients were divided into 3 groups: those with a history of ASCVD, those with no risk factors or history of ASCVD, and those with risk factors and no history of ASCVD. Patients were then categorized for their indication for aspirin use, which included either primary or secondary prevention of ASCVD. Patients were categorized into the primary prevention group if they had no history of ASCVD, whereas patients with a history of ASCVD were placed into the secondary prevention group.

ASCVD was defined as patients with acute coronary syndrome (ACS), history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral artery disease (PAD), including aortic aneurysm (all with an atherosclerotic origin). Possible ASCVD risk was defined as patients with DM with a major risk factor (family history of premature ASCVD, hypertension, dyslipidemia, smoking, chronic kidney disease [CKD]/albuminuria) or patients diagnosed with coronary artery disease without an event. The percentage of patients followed by a PACT pharmacist, the number of pharmacist follow-up visits during the study period, and the date of the first 81-mg aspirin pharmacy order that was filled at FHCC were also collected.

The secondary outcome of this study focused on patients who were using aspirin for primary prevention and assessed potential reasons that may warrant deprescribing aspirin therapy. One reason for deprescribing is that aspirin may not be indicated for some patients, including those with DM without cardiovascular complications, patients aged > 70 years, and/or patients with CKD (defined as estimated glomerular filtration rate < 60 mL/min). Another reason for deprescribing is contraindication, which included patients with coagulopathy, thrombocytopenia (defined as platelet count < 150,000 mL), a history of gastrointestinal bleeding, peptic ulcer disease or other major bleeds, and/or consistent use of medications that increase bleeding risk (such as nonsteroidal anti-inflammatory agents, steroids, or anticoagulants) for > 14 days.

The safety outcome of this study assessed bleeding events while on aspirin therapy. All patients were categorized depending on if they had a major, minor, or no bleeding event while on aspirin therapy. Hemorrhagic stroke, symptomatic intracranial bleeding, bleeds located in other critical sites or organs (intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial), bleeds causing hemodynamic instability requiring vasopressors, bleeds causing a > 2 g/dL hemoglobin drop since initiation of aspirin therapy, severe extracranial bleeding requiring transfusion or hospitalization, fatal bleeding, or bleeds requiring > 2 units of red blood cell transfusion were considered major bleeding events. Minor bleeding events were any events that did not meet the criteria for major bleeding, including bruising, bleeding gums, epistaxis, hemorrhoidal bleeds, and bleeding that did not require intervention or treatment.⁷

Patients were included if they were aged > 18 years, had an active prescription for 81-mg aspirin tablet on September 30, 2021, and were seen in FHCC PACT clinics or at affiliated community-based outpatient centers. Other doses of aspirin were excluded as the 81-mg dose is the standard dose for primary prevention of ASCVD in the United States. US Department of Defense patients, home-based primary care patients, and community living center patients were excluded in this study. Patients with an aspirin prescription from a non–US Department of Veterans Affairs (VA) facility and patients on aspirin for reasons other than cardiovascular protection (such as pain, fever, etc) also were excluded from this study.

Data were collected from the FHCC electronic health record. A list was generated to include all active prescriptions for aspirin filled at FHCC as of September 30, 2021. Data were reviewed before this date to capture primary and secondary outcomes. No information was gathered from the chart after that date. This project was approved by the Edward Hines, Jr. VA Hospital Institutional Review Board. The primary and secondary outcomes were reported using descriptive statistics.

Results

This study reviewed 140 patient records and 105 patients met inclusion criteria.

For the primary endpoint, 53 patients (50%) were on aspirin for secondary prevention and 52 (50%) were on aspirin for primary prevention. Of the 105 patients included in the study, 31 (30%) had a possible ASCVD risk and were taking aspirin for primary prevention, while 21 (20%) had no ASCVD and were taking aspirin for primary prevention. Of the 52 patients on aspirin for primary prevention, 31 patients (60%) had a possible risk for ASCVD. Of the 52 patients in the primary prevention group, 15 (29%) were followed by a pharmacist, and the average number of follow-up appointments was 4.

The secondary endpoint focused on patients taking aspirin for primary prevention and the factors that may warrant deprescribing aspirin. Of the 52 patients on aspirin for primary prevention, 25 patients were aged > 70 years, 15 patients were concurrently taking medications that may increase bleeding risk,

Discussion

The majority of patients in this study were on aspirin appropriately. Indications deemed appropriate for aspirin therapy include secondary prevention and primary prevention with a possible ASCVD risk. About 20% of the total patient population in this study was taking aspirin for primary prevention with no ASCVD risk. For these patients, the risk of bleeding likely outweighs the benefits of aspirin therapy as patients are at low risk for ASCVD; therefore, aspirin therapy is likely inappropriate in this patient population. These patients may be unnecessarily at an increased risk for bleeding and may benefit from deprescribing aspirin. For the safety of patients, HCPs should be continuously assessing the appropriateness of aspirin for primary prevention and deprescribing when necessary.

About one-third of the patients using aspirin for primary prevention were followed by a pharmacist. Pharmacists can play a key role in deprescribing aspirin for primary prevention when aspirin use is deemed inappropriate. About 30% of the total patient population in this study was on aspirin for primary prevention with possible ASCVD risk. This patient population may benefit from aspirin therapy as they are at a higher risk for ASCVD. For these patients, a risk/benefit discussion is necessary to determine the appropriateness of aspirin for primary prevention. This risk/benefit discussion should be a continuous conversation between patients and HCPs as different factors such as age and changes in comorbid conditions and medications may increase bleeding risk.

The secondary endpoint focused on patients taking aspirin for primary prevention and the factors that may warrant deprescribing aspirin. The most common factors seen in this study included patients who were aged > 70 years, patients who were concurrently taking medications that may increase bleeding risk, and patients with CKD. All of these factors increase bleeding risk, making the risks potentially outweigh the benefits of aspirin for primary prevention. These factors should be the primary focus when assessing patients on aspirin for primary prevention to promote deprescribing aspirin if deemed appropriate as they were the most prevalent in this study.

The safety endpoints focused on bleeding events as a whole as well as the bleeding events seen in the primary prevention group. There were 2 major bleeding events and 20 minor bleeding events in the primary prevention group. The number of bleeding events both major and minor further shows the need for a continuous risk/benefit discussion between patients and HCPs on continued aspirin use for primary prevention. The bleeding risk with aspirin is prevalent. HCPs should continue to assess for factors that increase the bleeding risk that may warrant deprescribing aspirin to prevent future bleeding events in this patient population.

Strengths and Limitations

As there have been recent updates to guidelines on the use of aspirin for primary prevention, a strength of this study is that it evaluates a topic that is relevant in health care. Another strength of this study is that it focuses on specific patient factors that HCPs can assess when determining whether aspirin for primary prevention is appropriate in their patients. These specific patient factors can also be used as a guide to help HCPs deprescribe aspirin for primary prevention when appropriate.

One of the limitations of this study is that bleeding events that occurred outside of the FHCC were unable to be assessed unless the HCP specifically commented on the bleeding event in the chart. This could potentially underestimate the bleeding events seen in this study. Another limitation is that the bleeding risk for patients who were not on aspirin was not assessed. There was no comparison group to ascertain whether the bleeding risk was higher in the aspirin group compared with a no aspirin group. However, many of the major clinical trials saw an increased risk of bleeding in the aspirin group compared with placebo.

Conclusions

Aspirin therapy for secondary prevention remains an important part of treatment. Aspirin therapy for primary prevention may be appropriate for patients with a possible ASCVD risk. The therapy may be inappropriate in cases where patients have an increased bleeding risk and low or no ASCVD risk. It is important to continuously assess the need for aspirin therapy for patients in the setting of primary prevention. Common factors seen in this study to warrant deprescribing aspirin for primary prevention include patients aged > 70 years, concurrent use of medications that increase bleeding risk, and patients with CKD. By assessing ASCVD risk as well as bleeding risk and having a risk/benefit discussion between the HCP and patient, aspirin used for primary prevention can be appropriately deprescribed when the risks of bleeding outweigh the benefits.

Acknowledgments

The authors thank the Captain James A. Lovell Federal Health Care Center research committee (Hong-Yen Vi, PharmD, BCPS; Shaiza Khan, PharmD, BCPS; Yinka Alaka, BPharm, PharmD; Jennifer Kwon, PharmD, BCOP) and coinvestigator Aeman Choudhury, PharmD, BCPS, BCACP.

Aspirin is an antiplatelet agent that binds irreversibly to COX-1 and COX-2 enzymes, which results in decreased prostaglandin and thromboxane A2 production and inhibition of platelet aggregation. Aspirin often is used for its antipyretic, analgesic, and antiplatelet properties. Its use in cardiovascular disease (CVD) has been studied extensively over the past few decades, and recent data are changing the framework for aspirin use in primary prevention of atherosclerotic cardiovascular disease (ASCVD). Primary prevention refers to efforts to prevent the incidence of cardiovascular events, whereas secondary prevention refers to efforts to prevent a cardiovascular event after one has occurred.¹ This differentiation is important as it guides the course of treatment.

Three trials published in 2018 evaluated aspirin use in primary prevention of ASCVD. The ASCEND trial evaluated aspirin use for primary prevention of ASCVD in patients with diabetes mellitus (DM). This study concluded that although aspirin prevented serious vascular events in patients with DM, the benefit observed was largely counteracted by the bleeding hazard.² The ARRIVE trial evaluated aspirin use for primary prevention in patients with a moderate CVD risk. The study concluded that aspirin use in patients at moderate risk of CVD could not be assessed due to the low incidence rate of CVD; however, the study concluded that aspirin did not reduce the incidence of cardiovascular events for patients at low CVD risk and that aspirin caused more mild gastrointestinal bleeds compared with placebo.³ The ASPREE trial evaluated aspirin use for primary prevention in patients aged > 70 years to determine whether its use prolonged a healthy lifespan. This trial concluded that patients who received daily aspirin were at a higher risk of major hemorrhage and that aspirin did not diminish CVD risk compared with placebo.⁴

These studies led to a paradigm shift in therapy to reevaluate aspirin use for primary prevention. Current indications for aspirin include secondary prevention of ASCVD (ie, myocardial infarction [MI], coronary artery bypass graft, transient ischemic attack [TIA], and stroke), venous thromboembolism prophylaxis in the setting of orthopedic surgery, or valvular disease with replacement and analgesia. It is important to note that certain clinical circumstances may warrant aspirin use for primary prevention of ASCVD on a patient-specific basis, and this decision should be made using a risk/benefit analysis with the patient.

In April 2022, the US Preventive Services Task Force (USPSTF) recommended against using low-dose aspirin for primary prevention of ASCVD in individuals aged ≥ 60 years. The USPSTF noted that for patients who have a ≥ 10%, 10-year CVD risk, the decision to initiate aspirin should be based on a risk/benefit discussion and may be beneficial in certain patient populations.⁵A 2019 National Heart, Lung, and Blood Institute survey found that 29 million Americans used aspirin for primary prevention of ASCVD, and 6.6 million of these Americans used aspirin for primary prevention without the recommendation of a health care professional (HCP). Almost half of these individuals were aged > 70 years and, therefore, at an increased risk for bleeding.⁶ With the recent studies and changes in guidelines highlighting a higher risk rather than benefit with the use of aspirin for primary prevention, the current use of aspirin for primary prevention in the United States needs to be readdressed.

HCPs should assess the appropriateness of aspirin use in their patients to ensure that the risks of aspirin do not outweigh the benefits. Pharmacists can play a vital role in the assessment of aspirin for primary prevention during patient visits and make recommendations to primary care practitioners to deprescribe aspirin when appropriate.

Methods

The objective of this study was to evaluate the appropriateness of aspirin therapy in patient aligned care team (PACT) clinics at the Captain James A. Lovell Federal Health Care Center (FHCC) in North Chicago, Illinois. The PACT clinics are a category of clinics that include all the primary care clinics at FHCC.

The primary outcome of this study was to determine the percentage of patients inappropriately on aspirin therapy. To assess the inappropriate use of aspirin, relevant history of ASCVD was collected. Patients were divided into 3 groups: those with a history of ASCVD, those with no risk factors or history of ASCVD, and those with risk factors and no history of ASCVD. Patients were then categorized for their indication for aspirin use, which included either primary or secondary prevention of ASCVD. Patients were categorized into the primary prevention group if they had no history of ASCVD, whereas patients with a history of ASCVD were placed into the secondary prevention group.

ASCVD was defined as patients with acute coronary syndrome (ACS), history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral artery disease (PAD), including aortic aneurysm (all with an atherosclerotic origin). Possible ASCVD risk was defined as patients with DM with a major risk factor (family history of premature ASCVD, hypertension, dyslipidemia, smoking, chronic kidney disease [CKD]/albuminuria) or patients diagnosed with coronary artery disease without an event. The percentage of patients followed by a PACT pharmacist, the number of pharmacist follow-up visits during the study period, and the date of the first 81-mg aspirin pharmacy order that was filled at FHCC were also collected.

The secondary outcome of this study focused on patients who were using aspirin for primary prevention and assessed potential reasons that may warrant deprescribing aspirin therapy. One reason for deprescribing is that aspirin may not be indicated for some patients, including those with DM without cardiovascular complications, patients aged > 70 years, and/or patients with CKD (defined as estimated glomerular filtration rate < 60 mL/min). Another reason for deprescribing is contraindication, which included patients with coagulopathy, thrombocytopenia (defined as platelet count < 150,000 mL), a history of gastrointestinal bleeding, peptic ulcer disease or other major bleeds, and/or consistent use of medications that increase bleeding risk (such as nonsteroidal anti-inflammatory agents, steroids, or anticoagulants) for > 14 days.

The safety outcome of this study assessed bleeding events while on aspirin therapy. All patients were categorized depending on if they had a major, minor, or no bleeding event while on aspirin therapy. Hemorrhagic stroke, symptomatic intracranial bleeding, bleeds located in other critical sites or organs (intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial), bleeds causing hemodynamic instability requiring vasopressors, bleeds causing a > 2 g/dL hemoglobin drop since initiation of aspirin therapy, severe extracranial bleeding requiring transfusion or hospitalization, fatal bleeding, or bleeds requiring > 2 units of red blood cell transfusion were considered major bleeding events. Minor bleeding events were any events that did not meet the criteria for major bleeding, including bruising, bleeding gums, epistaxis, hemorrhoidal bleeds, and bleeding that did not require intervention or treatment.⁷

Patients were included if they were aged > 18 years, had an active prescription for 81-mg aspirin tablet on September 30, 2021, and were seen in FHCC PACT clinics or at affiliated community-based outpatient centers. Other doses of aspirin were excluded as the 81-mg dose is the standard dose for primary prevention of ASCVD in the United States. US Department of Defense patients, home-based primary care patients, and community living center patients were excluded in this study. Patients with an aspirin prescription from a non–US Department of Veterans Affairs (VA) facility and patients on aspirin for reasons other than cardiovascular protection (such as pain, fever, etc) also were excluded from this study.

Data were collected from the FHCC electronic health record. A list was generated to include all active prescriptions for aspirin filled at FHCC as of September 30, 2021. Data were reviewed before this date to capture primary and secondary outcomes. No information was gathered from the chart after that date. This project was approved by the Edward Hines, Jr. VA Hospital Institutional Review Board. The primary and secondary outcomes were reported using descriptive statistics.

Results

This study reviewed 140 patient records and 105 patients met inclusion criteria.

For the primary endpoint, 53 patients (50%) were on aspirin for secondary prevention and 52 (50%) were on aspirin for primary prevention. Of the 105 patients included in the study, 31 (30%) had a possible ASCVD risk and were taking aspirin for primary prevention, while 21 (20%) had no ASCVD and were taking aspirin for primary prevention. Of the 52 patients on aspirin for primary prevention, 31 patients (60%) had a possible risk for ASCVD. Of the 52 patients in the primary prevention group, 15 (29%) were followed by a pharmacist, and the average number of follow-up appointments was 4.

The secondary endpoint focused on patients taking aspirin for primary prevention and the factors that may warrant deprescribing aspirin. Of the 52 patients on aspirin for primary prevention, 25 patients were aged > 70 years, 15 patients were concurrently taking medications that may increase bleeding risk,

Discussion

The majority of patients in this study were on aspirin appropriately. Indications deemed appropriate for aspirin therapy include secondary prevention and primary prevention with a possible ASCVD risk. About 20% of the total patient population in this study was taking aspirin for primary prevention with no ASCVD risk. For these patients, the risk of bleeding likely outweighs the benefits of aspirin therapy as patients are at low risk for ASCVD; therefore, aspirin therapy is likely inappropriate in this patient population. These patients may be unnecessarily at an increased risk for bleeding and may benefit from deprescribing aspirin. For the safety of patients, HCPs should be continuously assessing the appropriateness of aspirin for primary prevention and deprescribing when necessary.

About one-third of the patients using aspirin for primary prevention were followed by a pharmacist. Pharmacists can play a key role in deprescribing aspirin for primary prevention when aspirin use is deemed inappropriate. About 30% of the total patient population in this study was on aspirin for primary prevention with possible ASCVD risk. This patient population may benefit from aspirin therapy as they are at a higher risk for ASCVD. For these patients, a risk/benefit discussion is necessary to determine the appropriateness of aspirin for primary prevention. This risk/benefit discussion should be a continuous conversation between patients and HCPs as different factors such as age and changes in comorbid conditions and medications may increase bleeding risk.

The secondary endpoint focused on patients taking aspirin for primary prevention and the factors that may warrant deprescribing aspirin. The most common factors seen in this study included patients who were aged > 70 years, patients who were concurrently taking medications that may increase bleeding risk, and patients with CKD. All of these factors increase bleeding risk, making the risks potentially outweigh the benefits of aspirin for primary prevention. These factors should be the primary focus when assessing patients on aspirin for primary prevention to promote deprescribing aspirin if deemed appropriate as they were the most prevalent in this study.

The safety endpoints focused on bleeding events as a whole as well as the bleeding events seen in the primary prevention group. There were 2 major bleeding events and 20 minor bleeding events in the primary prevention group. The number of bleeding events both major and minor further shows the need for a continuous risk/benefit discussion between patients and HCPs on continued aspirin use for primary prevention. The bleeding risk with aspirin is prevalent. HCPs should continue to assess for factors that increase the bleeding risk that may warrant deprescribing aspirin to prevent future bleeding events in this patient population.

Strengths and Limitations

As there have been recent updates to guidelines on the use of aspirin for primary prevention, a strength of this study is that it evaluates a topic that is relevant in health care. Another strength of this study is that it focuses on specific patient factors that HCPs can assess when determining whether aspirin for primary prevention is appropriate in their patients. These specific patient factors can also be used as a guide to help HCPs deprescribe aspirin for primary prevention when appropriate.

One of the limitations of this study is that bleeding events that occurred outside of the FHCC were unable to be assessed unless the HCP specifically commented on the bleeding event in the chart. This could potentially underestimate the bleeding events seen in this study. Another limitation is that the bleeding risk for patients who were not on aspirin was not assessed. There was no comparison group to ascertain whether the bleeding risk was higher in the aspirin group compared with a no aspirin group. However, many of the major clinical trials saw an increased risk of bleeding in the aspirin group compared with placebo.

Conclusions

Aspirin therapy for secondary prevention remains an important part of treatment. Aspirin therapy for primary prevention may be appropriate for patients with a possible ASCVD risk. The therapy may be inappropriate in cases where patients have an increased bleeding risk and low or no ASCVD risk. It is important to continuously assess the need for aspirin therapy for patients in the setting of primary prevention. Common factors seen in this study to warrant deprescribing aspirin for primary prevention include patients aged > 70 years, concurrent use of medications that increase bleeding risk, and patients with CKD. By assessing ASCVD risk as well as bleeding risk and having a risk/benefit discussion between the HCP and patient, aspirin used for primary prevention can be appropriately deprescribed when the risks of bleeding outweigh the benefits.

Acknowledgments

The authors thank the Captain James A. Lovell Federal Health Care Center research committee (Hong-Yen Vi, PharmD, BCPS; Shaiza Khan, PharmD, BCPS; Yinka Alaka, BPharm, PharmD; Jennifer Kwon, PharmD, BCOP) and coinvestigator Aeman Choudhury, PharmD, BCPS, BCACP.

Aspirin is an antiplatelet agent that binds irreversibly to COX-1 and COX-2 enzymes, which results in decreased prostaglandin and thromboxane A2 production and inhibition of platelet aggregation. Aspirin often is used for its antipyretic, analgesic, and antiplatelet properties. Its use in cardiovascular disease (CVD) has been studied extensively over the past few decades, and recent data are changing the framework for aspirin use in primary prevention of atherosclerotic cardiovascular disease (ASCVD). Primary prevention refers to efforts to prevent the incidence of cardiovascular events, whereas secondary prevention refers to efforts to prevent a cardiovascular event after one has occurred.¹ This differentiation is important as it guides the course of treatment.

Three trials published in 2018 evaluated aspirin use in primary prevention of ASCVD. The ASCEND trial evaluated aspirin use for primary prevention of ASCVD in patients with diabetes mellitus (DM). This study concluded that although aspirin prevented serious vascular events in patients with DM, the benefit observed was largely counteracted by the bleeding hazard.² The ARRIVE trial evaluated aspirin use for primary prevention in patients with a moderate CVD risk. The study concluded that aspirin use in patients at moderate risk of CVD could not be assessed due to the low incidence rate of CVD; however, the study concluded that aspirin did not reduce the incidence of cardiovascular events for patients at low CVD risk and that aspirin caused more mild gastrointestinal bleeds compared with placebo.³ The ASPREE trial evaluated aspirin use for primary prevention in patients aged > 70 years to determine whether its use prolonged a healthy lifespan. This trial concluded that patients who received daily aspirin were at a higher risk of major hemorrhage and that aspirin did not diminish CVD risk compared with placebo.⁴

These studies led to a paradigm shift in therapy to reevaluate aspirin use for primary prevention. Current indications for aspirin include secondary prevention of ASCVD (ie, myocardial infarction [MI], coronary artery bypass graft, transient ischemic attack [TIA], and stroke), venous thromboembolism prophylaxis in the setting of orthopedic surgery, or valvular disease with replacement and analgesia. It is important to note that certain clinical circumstances may warrant aspirin use for primary prevention of ASCVD on a patient-specific basis, and this decision should be made using a risk/benefit analysis with the patient.

In April 2022, the US Preventive Services Task Force (USPSTF) recommended against using low-dose aspirin for primary prevention of ASCVD in individuals aged ≥ 60 years. The USPSTF noted that for patients who have a ≥ 10%, 10-year CVD risk, the decision to initiate aspirin should be based on a risk/benefit discussion and may be beneficial in certain patient populations.⁵A 2019 National Heart, Lung, and Blood Institute survey found that 29 million Americans used aspirin for primary prevention of ASCVD, and 6.6 million of these Americans used aspirin for primary prevention without the recommendation of a health care professional (HCP). Almost half of these individuals were aged > 70 years and, therefore, at an increased risk for bleeding.⁶ With the recent studies and changes in guidelines highlighting a higher risk rather than benefit with the use of aspirin for primary prevention, the current use of aspirin for primary prevention in the United States needs to be readdressed.

HCPs should assess the appropriateness of aspirin use in their patients to ensure that the risks of aspirin do not outweigh the benefits. Pharmacists can play a vital role in the assessment of aspirin for primary prevention during patient visits and make recommendations to primary care practitioners to deprescribe aspirin when appropriate.

Methods

The objective of this study was to evaluate the appropriateness of aspirin therapy in patient aligned care team (PACT) clinics at the Captain James A. Lovell Federal Health Care Center (FHCC) in North Chicago, Illinois. The PACT clinics are a category of clinics that include all the primary care clinics at FHCC.

The primary outcome of this study was to determine the percentage of patients inappropriately on aspirin therapy. To assess the inappropriate use of aspirin, relevant history of ASCVD was collected. Patients were divided into 3 groups: those with a history of ASCVD, those with no risk factors or history of ASCVD, and those with risk factors and no history of ASCVD. Patients were then categorized for their indication for aspirin use, which included either primary or secondary prevention of ASCVD. Patients were categorized into the primary prevention group if they had no history of ASCVD, whereas patients with a history of ASCVD were placed into the secondary prevention group.

ASCVD was defined as patients with acute coronary syndrome (ACS), history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral artery disease (PAD), including aortic aneurysm (all with an atherosclerotic origin). Possible ASCVD risk was defined as patients with DM with a major risk factor (family history of premature ASCVD, hypertension, dyslipidemia, smoking, chronic kidney disease [CKD]/albuminuria) or patients diagnosed with coronary artery disease without an event. The percentage of patients followed by a PACT pharmacist, the number of pharmacist follow-up visits during the study period, and the date of the first 81-mg aspirin pharmacy order that was filled at FHCC were also collected.

The secondary outcome of this study focused on patients who were using aspirin for primary prevention and assessed potential reasons that may warrant deprescribing aspirin therapy. One reason for deprescribing is that aspirin may not be indicated for some patients, including those with DM without cardiovascular complications, patients aged > 70 years, and/or patients with CKD (defined as estimated glomerular filtration rate < 60 mL/min). Another reason for deprescribing is contraindication, which included patients with coagulopathy, thrombocytopenia (defined as platelet count < 150,000 mL), a history of gastrointestinal bleeding, peptic ulcer disease or other major bleeds, and/or consistent use of medications that increase bleeding risk (such as nonsteroidal anti-inflammatory agents, steroids, or anticoagulants) for > 14 days.

The safety outcome of this study assessed bleeding events while on aspirin therapy. All patients were categorized depending on if they had a major, minor, or no bleeding event while on aspirin therapy. Hemorrhagic stroke, symptomatic intracranial bleeding, bleeds located in other critical sites or organs (intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial), bleeds causing hemodynamic instability requiring vasopressors, bleeds causing a > 2 g/dL hemoglobin drop since initiation of aspirin therapy, severe extracranial bleeding requiring transfusion or hospitalization, fatal bleeding, or bleeds requiring > 2 units of red blood cell transfusion were considered major bleeding events. Minor bleeding events were any events that did not meet the criteria for major bleeding, including bruising, bleeding gums, epistaxis, hemorrhoidal bleeds, and bleeding that did not require intervention or treatment.⁷

Patients were included if they were aged > 18 years, had an active prescription for 81-mg aspirin tablet on September 30, 2021, and were seen in FHCC PACT clinics or at affiliated community-based outpatient centers. Other doses of aspirin were excluded as the 81-mg dose is the standard dose for primary prevention of ASCVD in the United States. US Department of Defense patients, home-based primary care patients, and community living center patients were excluded in this study. Patients with an aspirin prescription from a non–US Department of Veterans Affairs (VA) facility and patients on aspirin for reasons other than cardiovascular protection (such as pain, fever, etc) also were excluded from this study.

Data were collected from the FHCC electronic health record. A list was generated to include all active prescriptions for aspirin filled at FHCC as of September 30, 2021. Data were reviewed before this date to capture primary and secondary outcomes. No information was gathered from the chart after that date. This project was approved by the Edward Hines, Jr. VA Hospital Institutional Review Board. The primary and secondary outcomes were reported using descriptive statistics.

Results

This study reviewed 140 patient records and 105 patients met inclusion criteria.

For the primary endpoint, 53 patients (50%) were on aspirin for secondary prevention and 52 (50%) were on aspirin for primary prevention. Of the 105 patients included in the study, 31 (30%) had a possible ASCVD risk and were taking aspirin for primary prevention, while 21 (20%) had no ASCVD and were taking aspirin for primary prevention. Of the 52 patients on aspirin for primary prevention, 31 patients (60%) had a possible risk for ASCVD. Of the 52 patients in the primary prevention group, 15 (29%) were followed by a pharmacist, and the average number of follow-up appointments was 4.

The secondary endpoint focused on patients taking aspirin for primary prevention and the factors that may warrant deprescribing aspirin. Of the 52 patients on aspirin for primary prevention, 25 patients were aged > 70 years, 15 patients were concurrently taking medications that may increase bleeding risk,

Discussion

The majority of patients in this study were on aspirin appropriately. Indications deemed appropriate for aspirin therapy include secondary prevention and primary prevention with a possible ASCVD risk. About 20% of the total patient population in this study was taking aspirin for primary prevention with no ASCVD risk. For these patients, the risk of bleeding likely outweighs the benefits of aspirin therapy as patients are at low risk for ASCVD; therefore, aspirin therapy is likely inappropriate in this patient population. These patients may be unnecessarily at an increased risk for bleeding and may benefit from deprescribing aspirin. For the safety of patients, HCPs should be continuously assessing the appropriateness of aspirin for primary prevention and deprescribing when necessary.

About one-third of the patients using aspirin for primary prevention were followed by a pharmacist. Pharmacists can play a key role in deprescribing aspirin for primary prevention when aspirin use is deemed inappropriate. About 30% of the total patient population in this study was on aspirin for primary prevention with possible ASCVD risk. This patient population may benefit from aspirin therapy as they are at a higher risk for ASCVD. For these patients, a risk/benefit discussion is necessary to determine the appropriateness of aspirin for primary prevention. This risk/benefit discussion should be a continuous conversation between patients and HCPs as different factors such as age and changes in comorbid conditions and medications may increase bleeding risk.

The secondary endpoint focused on patients taking aspirin for primary prevention and the factors that may warrant deprescribing aspirin. The most common factors seen in this study included patients who were aged > 70 years, patients who were concurrently taking medications that may increase bleeding risk, and patients with CKD. All of these factors increase bleeding risk, making the risks potentially outweigh the benefits of aspirin for primary prevention. These factors should be the primary focus when assessing patients on aspirin for primary prevention to promote deprescribing aspirin if deemed appropriate as they were the most prevalent in this study.

The safety endpoints focused on bleeding events as a whole as well as the bleeding events seen in the primary prevention group. There were 2 major bleeding events and 20 minor bleeding events in the primary prevention group. The number of bleeding events both major and minor further shows the need for a continuous risk/benefit discussion between patients and HCPs on continued aspirin use for primary prevention. The bleeding risk with aspirin is prevalent. HCPs should continue to assess for factors that increase the bleeding risk that may warrant deprescribing aspirin to prevent future bleeding events in this patient population.

Strengths and Limitations

As there have been recent updates to guidelines on the use of aspirin for primary prevention, a strength of this study is that it evaluates a topic that is relevant in health care. Another strength of this study is that it focuses on specific patient factors that HCPs can assess when determining whether aspirin for primary prevention is appropriate in their patients. These specific patient factors can also be used as a guide to help HCPs deprescribe aspirin for primary prevention when appropriate.

One of the limitations of this study is that bleeding events that occurred outside of the FHCC were unable to be assessed unless the HCP specifically commented on the bleeding event in the chart. This could potentially underestimate the bleeding events seen in this study. Another limitation is that the bleeding risk for patients who were not on aspirin was not assessed. There was no comparison group to ascertain whether the bleeding risk was higher in the aspirin group compared with a no aspirin group. However, many of the major clinical trials saw an increased risk of bleeding in the aspirin group compared with placebo.

Conclusions

Aspirin therapy for secondary prevention remains an important part of treatment. Aspirin therapy for primary prevention may be appropriate for patients with a possible ASCVD risk. The therapy may be inappropriate in cases where patients have an increased bleeding risk and low or no ASCVD risk. It is important to continuously assess the need for aspirin therapy for patients in the setting of primary prevention. Common factors seen in this study to warrant deprescribing aspirin for primary prevention include patients aged > 70 years, concurrent use of medications that increase bleeding risk, and patients with CKD. By assessing ASCVD risk as well as bleeding risk and having a risk/benefit discussion between the HCP and patient, aspirin used for primary prevention can be appropriately deprescribed when the risks of bleeding outweigh the benefits.

Acknowledgments

The authors thank the Captain James A. Lovell Federal Health Care Center research committee (Hong-Yen Vi, PharmD, BCPS; Shaiza Khan, PharmD, BCPS; Yinka Alaka, BPharm, PharmD; Jennifer Kwon, PharmD, BCOP) and coinvestigator Aeman Choudhury, PharmD, BCPS, BCACP.

The Society for Cardiovascular Angiography and Interventions has issued an updated expert consensus statement to provide clearer guidance on what percutaneous coronary angioplasty cases can be done in outpatient settings such as ambulatory surgery centers (ASCs) and office-based laboratories and which are best left to more traditional settings, such as hospitals with full cardiac support.

PCI has evolved quickly since SCAI issued its last update almost 9 years ago. The updated statement, published online in the Journal of the Society for Cardiovascular Angiography and Interventions, notes that the proportion of same-day PCI discharges has increased from 4.5% in 2009 to 28.6% in 2017.

The statement also notes that the Medicare facility fee for outpatient PCI in an ASC is about 40% less than the hospital fee: $6,111 versus $10,258 for the facility fee for 2022. The Centers for Medicare & Medicaid Services in 2020 extended coverage for PCIs in ASCs.
 

Rationale for update

Writing group chair Cindy Grines, MD, explained the rationale for updating the statement now. “The 2014 SCAI statement was very conservative, recommending only the simplest of cases be done without surgical backup,” Dr. Grines, chief scientific officer at Northside Hospital Cardiovascular Institute in Atlanta, said in an interview.

The statement drew on 12 global studies from 2015 to 2022 that evaluated more than 8 million PCIs at facilities with and without surgery on site. Dr. Grines noted those studies reported complication rates as low as 0.1% in PCI procedures in centers without surgical backup.

She also noted that the writing committee also received input that “by restricting the use of certain devices such as atherectomy, some patients who needed it as a bailout could be harmed.”

Another factor in prompting the statement update, Dr. Grines said: “Many hospitals have consolidated into heath systems, and these systems consolidated bypass surgery into one center. Therefore, centers with high volume, experienced operators, and excellent outcomes were now left with no surgery on site. It didn’t make sense to withdraw complex PCI from these centers who haven’t sent a patient for emergency bypass in several years.”
 

Statement guidance

The centerpiece of the update is an algorithm that covers the range of settings for PCI, from having a surgeon on site to ACS or office-based lab.

For example, indications for on-site surgical capability are PCI of the last remaining patent vessel or retrograde approach to epicardial chronic total occlusion (CTO), and when the patient is a candidate for surgery.

Indications for PCI in a hospital without on-site surgery but with percutaneous ventricular assist device or extracorporeal membrane oxygenation, calcium modification devices and high PCI volume are patients with decreased left ventricular ejection fraction, unprotected left main artery, CTO, or degenerated vein grafts.

For patients at high risk for transfusion, acute kidney injury or vascular complications, or who have high baseline respiratory risk, a hospital without on-site surgery but with respiratory care, blood bank, and vascular surgery services is indicated.

And for patients with none of the aforementioned characteristics or risks, ASC, office-based lab, or any hospital facility is acceptable.

The statement also provides guidance for operator experience. Those with less than 3 years’ experience, considered to have limited exposure to atherectomy devices and limited ST-segmented elevation MI (STEMI)/shock experience, should avoid doing PCIs in an ASC and performing atherectomy cases on their own, and have a colleague review case selection and assist in higher-risk cases. Experienced (3-10 years’ experience) and very experienced (more than 10 years’) should be able to perform in any setting and be competent with, if not highly experienced with, atherectomy and STEMI/shock.

Dr. Grines acknowledged the writing group didn’t want to set a specific operator volume requirement. “However, we recognize that lifetime operator experience is particularly important in more complex cases such as CTO, atherectomy, bifurcation stenoses, etc.,” she said. “In addition, performing these cases at a larger institution that has other operators that may assist in the event of a complication is very important. Specifically, we did not believe that recent fellow graduates with less than 3 years in practice or low-volume operators should attempt higher-risk cases in a no-SOS [surgeon-on-site] setting or perform cases in ASC or office-based labs where no colleagues are there to assist in case of a complication.”

In an interview, Gregory J. Dehmer, MD, professor of medicine at Virginia Tech University, Roanoke, reprised the theme of his accompanying editorial. “Things are evolving again, as Bob Dylan would say, ‘The Times They Are A-Changin’, so it’s very timely that the society in collaboration with other professional societies updated what are guidelines and rules of road if you’re going to do PCI in ASCs or office based laboratories,” said Dr. Dehmer, who chaired the writing committees of the 2007 and 2014 SCAI expert statements on PCI.

Having this statement is important for centers that don’t have on-site surgical backup, he said. “You couldn’t sustain a PCI operation at a rural hospital on just acute MIs alone. The key thing is that all of this built upon numerous studies both in the U.S. and abroad that showed the safety of doing elective cases – not only STEMIs, but elective PCI – at facilities without on-site surgery.”

CMS pushed the envelope when it decided to reimburse PCIs done in ASCs, Dr. Dehmer said. “That was not based on a lot of data. It was kind of a leap of faith. It’s logical that this should work, but in order for it to work and be safe for pats you have to follow the rules. That’s where SCAI stepped in at this point and said this is a whole new environment and we need to set some ground rules for physicians of who and who should not be having these procures in an office-based lab or an ambulatory surgery center.”

Dr. Grines and Dr. Dehmer have no relevant disclosures.
 

The Society for Cardiovascular Angiography and Interventions has issued an updated expert consensus statement to provide clearer guidance on what percutaneous coronary angioplasty cases can be done in outpatient settings such as ambulatory surgery centers (ASCs) and office-based laboratories and which are best left to more traditional settings, such as hospitals with full cardiac support.

PCI has evolved quickly since SCAI issued its last update almost 9 years ago. The updated statement, published online in the Journal of the Society for Cardiovascular Angiography and Interventions, notes that the proportion of same-day PCI discharges has increased from 4.5% in 2009 to 28.6% in 2017.

The statement also notes that the Medicare facility fee for outpatient PCI in an ASC is about 40% less than the hospital fee: $6,111 versus $10,258 for the facility fee for 2022. The Centers for Medicare & Medicaid Services in 2020 extended coverage for PCIs in ASCs.
 

Rationale for update

Writing group chair Cindy Grines, MD, explained the rationale for updating the statement now. “The 2014 SCAI statement was very conservative, recommending only the simplest of cases be done without surgical backup,” Dr. Grines, chief scientific officer at Northside Hospital Cardiovascular Institute in Atlanta, said in an interview.

The statement drew on 12 global studies from 2015 to 2022 that evaluated more than 8 million PCIs at facilities with and without surgery on site. Dr. Grines noted those studies reported complication rates as low as 0.1% in PCI procedures in centers without surgical backup.

She also noted that the writing committee also received input that “by restricting the use of certain devices such as atherectomy, some patients who needed it as a bailout could be harmed.”

Another factor in prompting the statement update, Dr. Grines said: “Many hospitals have consolidated into heath systems, and these systems consolidated bypass surgery into one center. Therefore, centers with high volume, experienced operators, and excellent outcomes were now left with no surgery on site. It didn’t make sense to withdraw complex PCI from these centers who haven’t sent a patient for emergency bypass in several years.”
 

Statement guidance

The centerpiece of the update is an algorithm that covers the range of settings for PCI, from having a surgeon on site to ACS or office-based lab.

For example, indications for on-site surgical capability are PCI of the last remaining patent vessel or retrograde approach to epicardial chronic total occlusion (CTO), and when the patient is a candidate for surgery.

Indications for PCI in a hospital without on-site surgery but with percutaneous ventricular assist device or extracorporeal membrane oxygenation, calcium modification devices and high PCI volume are patients with decreased left ventricular ejection fraction, unprotected left main artery, CTO, or degenerated vein grafts.

For patients at high risk for transfusion, acute kidney injury or vascular complications, or who have high baseline respiratory risk, a hospital without on-site surgery but with respiratory care, blood bank, and vascular surgery services is indicated.

And for patients with none of the aforementioned characteristics or risks, ASC, office-based lab, or any hospital facility is acceptable.

The statement also provides guidance for operator experience. Those with less than 3 years’ experience, considered to have limited exposure to atherectomy devices and limited ST-segmented elevation MI (STEMI)/shock experience, should avoid doing PCIs in an ASC and performing atherectomy cases on their own, and have a colleague review case selection and assist in higher-risk cases. Experienced (3-10 years’ experience) and very experienced (more than 10 years’) should be able to perform in any setting and be competent with, if not highly experienced with, atherectomy and STEMI/shock.

Dr. Grines acknowledged the writing group didn’t want to set a specific operator volume requirement. “However, we recognize that lifetime operator experience is particularly important in more complex cases such as CTO, atherectomy, bifurcation stenoses, etc.,” she said. “In addition, performing these cases at a larger institution that has other operators that may assist in the event of a complication is very important. Specifically, we did not believe that recent fellow graduates with less than 3 years in practice or low-volume operators should attempt higher-risk cases in a no-SOS [surgeon-on-site] setting or perform cases in ASC or office-based labs where no colleagues are there to assist in case of a complication.”

In an interview, Gregory J. Dehmer, MD, professor of medicine at Virginia Tech University, Roanoke, reprised the theme of his accompanying editorial. “Things are evolving again, as Bob Dylan would say, ‘The Times They Are A-Changin’, so it’s very timely that the society in collaboration with other professional societies updated what are guidelines and rules of road if you’re going to do PCI in ASCs or office based laboratories,” said Dr. Dehmer, who chaired the writing committees of the 2007 and 2014 SCAI expert statements on PCI.

Having this statement is important for centers that don’t have on-site surgical backup, he said. “You couldn’t sustain a PCI operation at a rural hospital on just acute MIs alone. The key thing is that all of this built upon numerous studies both in the U.S. and abroad that showed the safety of doing elective cases – not only STEMIs, but elective PCI – at facilities without on-site surgery.”

CMS pushed the envelope when it decided to reimburse PCIs done in ASCs, Dr. Dehmer said. “That was not based on a lot of data. It was kind of a leap of faith. It’s logical that this should work, but in order for it to work and be safe for pats you have to follow the rules. That’s where SCAI stepped in at this point and said this is a whole new environment and we need to set some ground rules for physicians of who and who should not be having these procures in an office-based lab or an ambulatory surgery center.”

Dr. Grines and Dr. Dehmer have no relevant disclosures.
 

The Society for Cardiovascular Angiography and Interventions has issued an updated expert consensus statement to provide clearer guidance on what percutaneous coronary angioplasty cases can be done in outpatient settings such as ambulatory surgery centers (ASCs) and office-based laboratories and which are best left to more traditional settings, such as hospitals with full cardiac support.

PCI has evolved quickly since SCAI issued its last update almost 9 years ago. The updated statement, published online in the Journal of the Society for Cardiovascular Angiography and Interventions, notes that the proportion of same-day PCI discharges has increased from 4.5% in 2009 to 28.6% in 2017.

The statement also notes that the Medicare facility fee for outpatient PCI in an ASC is about 40% less than the hospital fee: $6,111 versus $10,258 for the facility fee for 2022. The Centers for Medicare & Medicaid Services in 2020 extended coverage for PCIs in ASCs.
 

Rationale for update

Writing group chair Cindy Grines, MD, explained the rationale for updating the statement now. “The 2014 SCAI statement was very conservative, recommending only the simplest of cases be done without surgical backup,” Dr. Grines, chief scientific officer at Northside Hospital Cardiovascular Institute in Atlanta, said in an interview.

The statement drew on 12 global studies from 2015 to 2022 that evaluated more than 8 million PCIs at facilities with and without surgery on site. Dr. Grines noted those studies reported complication rates as low as 0.1% in PCI procedures in centers without surgical backup.

She also noted that the writing committee also received input that “by restricting the use of certain devices such as atherectomy, some patients who needed it as a bailout could be harmed.”

Another factor in prompting the statement update, Dr. Grines said: “Many hospitals have consolidated into heath systems, and these systems consolidated bypass surgery into one center. Therefore, centers with high volume, experienced operators, and excellent outcomes were now left with no surgery on site. It didn’t make sense to withdraw complex PCI from these centers who haven’t sent a patient for emergency bypass in several years.”
 

Statement guidance

The centerpiece of the update is an algorithm that covers the range of settings for PCI, from having a surgeon on site to ACS or office-based lab.

For example, indications for on-site surgical capability are PCI of the last remaining patent vessel or retrograde approach to epicardial chronic total occlusion (CTO), and when the patient is a candidate for surgery.

Indications for PCI in a hospital without on-site surgery but with percutaneous ventricular assist device or extracorporeal membrane oxygenation, calcium modification devices and high PCI volume are patients with decreased left ventricular ejection fraction, unprotected left main artery, CTO, or degenerated vein grafts.

For patients at high risk for transfusion, acute kidney injury or vascular complications, or who have high baseline respiratory risk, a hospital without on-site surgery but with respiratory care, blood bank, and vascular surgery services is indicated.

And for patients with none of the aforementioned characteristics or risks, ASC, office-based lab, or any hospital facility is acceptable.

The statement also provides guidance for operator experience. Those with less than 3 years’ experience, considered to have limited exposure to atherectomy devices and limited ST-segmented elevation MI (STEMI)/shock experience, should avoid doing PCIs in an ASC and performing atherectomy cases on their own, and have a colleague review case selection and assist in higher-risk cases. Experienced (3-10 years’ experience) and very experienced (more than 10 years’) should be able to perform in any setting and be competent with, if not highly experienced with, atherectomy and STEMI/shock.

Dr. Grines acknowledged the writing group didn’t want to set a specific operator volume requirement. “However, we recognize that lifetime operator experience is particularly important in more complex cases such as CTO, atherectomy, bifurcation stenoses, etc.,” she said. “In addition, performing these cases at a larger institution that has other operators that may assist in the event of a complication is very important. Specifically, we did not believe that recent fellow graduates with less than 3 years in practice or low-volume operators should attempt higher-risk cases in a no-SOS [surgeon-on-site] setting or perform cases in ASC or office-based labs where no colleagues are there to assist in case of a complication.”

In an interview, Gregory J. Dehmer, MD, professor of medicine at Virginia Tech University, Roanoke, reprised the theme of his accompanying editorial. “Things are evolving again, as Bob Dylan would say, ‘The Times They Are A-Changin’, so it’s very timely that the society in collaboration with other professional societies updated what are guidelines and rules of road if you’re going to do PCI in ASCs or office based laboratories,” said Dr. Dehmer, who chaired the writing committees of the 2007 and 2014 SCAI expert statements on PCI.

Having this statement is important for centers that don’t have on-site surgical backup, he said. “You couldn’t sustain a PCI operation at a rural hospital on just acute MIs alone. The key thing is that all of this built upon numerous studies both in the U.S. and abroad that showed the safety of doing elective cases – not only STEMIs, but elective PCI – at facilities without on-site surgery.”

CMS pushed the envelope when it decided to reimburse PCIs done in ASCs, Dr. Dehmer said. “That was not based on a lot of data. It was kind of a leap of faith. It’s logical that this should work, but in order for it to work and be safe for pats you have to follow the rules. That’s where SCAI stepped in at this point and said this is a whole new environment and we need to set some ground rules for physicians of who and who should not be having these procures in an office-based lab or an ambulatory surgery center.”

Dr. Grines and Dr. Dehmer have no relevant disclosures.
 

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape series telling these stories.

I was coming off a 48-hour shift plus a day of doing outpatient sedation at Sparrow Hospital in Lansing. It was December and Michigan-cold. The roads were fine – no snow – but I noticed an unusual amount of traffic on the freeway. Then I saw smoke coming from an overpass up ahead.

I drove on the side of the road where I wasn’t really supposed to and got closer. An SUV had crashed into one of the big concrete structures under the bridge. I saw people running around but wasn’t able to spot EMS or any health care workers. From where I was, I could identify four kids who had already been extricated and one adult still in the driver’s seat. I estimated the kids’ ages were around 7, 5, 3, and an infant who was a few months old. I left my car and went to help.

I was able to peg the ages correctly because I’m a pediatric critical care physician. As a specialty, we’re not commonly known. We oversee patient care in intensive care units, except the patients are children. Part of the job is that we’re experts at triaging. We recognize what’s life-threatening and less so.

The kids were with some adults who kept them warm with blankets. I examined each of them. The infant was asleep but arousable and acting like a normal baby. The 3-year-old boy was vomiting and appeared very fatigued. The 5-year-old boy had a forehead laceration and was in and out of consciousness. The 7-year-old girl was screaming because of different injuries.

While all of the children were concerning to me, I identified one in particular: the 5-year-old boy. It was obvious he needed serious medical attention and fast. So, I kept that little guy in mind. The others had sustained significant injuries, but my best guess was they could get to a hospital and be stabilized.

That said, I’m a trauma instructor, and one of the things I always tell trainees is: Trauma is a black box. On the outside, it may seem like a patient doesn’t have a lot of injuries. But underneath, there might be something worse, like a brain injury. Or the chest might have taken a blunt impact affecting the heart. There may be internal bleeding somewhere in the belly. It’s really hard to tease out what exactly is going on without equipment and testing.

I didn’t even have a pulse oximeter or heart rate monitor. I pretty much just went by the appearance of the child: pulse, heart rate, awareness, things like that.

After the kids, I moved to look at the man in the car. The front end had already caught fire. I could see the driver – the kids’ father, I guessed – unconscious and hunched over. I was wondering, Why hasn’t this guy been extricated?

I approached the car on the front passenger side. And then I just had this feeling. I knew I needed to step back. Immediately.

I did. And a few seconds later, the whole car exploded in flames.

I believe God is in control of everything. I tried to get to that man. But the scene was unsafe. Later I learned that several people, including a young nurse at the scene, had tried to get to him as well.

When EMS came, I identified myself. Obviously, these people do very, very important work. But they may be more used to the 60-year-old heart attack, the 25-year-old gunshot wound, the occasional ill child. I thought that four kids – each with possible critical poly-traumatic injuries – posed a challenge to anyone.

I told them, “This is what I do on a daily basis, and this is the kid I’m worried about the most. The other kids are definitely worrisome, but I would prioritize getting this kid to the hospital first. Can I ride with you?” They agreed.

We got that boy and his older sister into the first ambulance (she was in a lot of pain, the result of a femur fracture). The two other kids rode in the second ambulance. The hospital where I had just left was 10 minutes away. I called the other pediatric critical care doctor there, my partner. He thought I was calling for a routine issue – no such luck. I said, “I’m with four kids who are level-1 traumas in two ambulances and I’m heading to the hospital right now, ETA 10 minutes.”

En route, I thought the little boy might lose consciousness at any moment. He needed a breathing tube, and I debated whether it should be done in the ambulance vs. waiting until we got to the emergency room. Based on my judgment and his vital signs, I elected to wait to have it done it in a more controlled environment. Had I felt like he was in immediate need of an airway, I would’ve attempted it. But those are the tough calls that you must make.

My partner had alerted the trauma and emergency medicine teams at the hospital. By the time we arrived, my partner was down in the ER with the trauma team and ER staff. Everyone was ready. Then it was like divide and conquer. He attended to one of the kids. The ER team and I were with the little guy I was really worried about. We had his breathing tube in within minutes. The trauma team attended to the other two.

All the kids were stabilized and then admitted to the pediatric intensive care unit. I’m happy to say that all of them did well in the end. Even the little guy I was worried about the most.

I must say this incident gave me perspective on what EMS goes through. The field medicine we do in the United States is still in its infancy in a lot of ways. One of the things I would love to see in the future is a mobile ICU. After a critical illness hits, sometimes you only have seconds, minutes, maybe hours if you’re lucky. The earlier you can get patients the treatment they need, the better the outcomes.

I like taking care of critically ill children and their families. It fits my personality. And it’s a wonderful cause. But you have to be ready for tragic cases like this one. Yes, the children came out alive, but the accident claimed a life in a horrible way. And there was nothing I could do about it.

Critical care takes an emotional, psychological, and physical toll. It’s a roller coaster: Some kids do well; some kids don’t do well. All I can do is hold myself accountable. I keep my emotions in check, whether the outcome is positive or negative. And I do my best.
 

Mohamed Hani Farhat, MD, is a pediatric critical care physician at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor and Sparrow Hospital in Lansing, Mich. Are you a physician with a dramatic medical story outside the clinic? Medscape would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary of your story to [email protected] . A version of this article appeared on Medscape.com.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape series telling these stories.

I was coming off a 48-hour shift plus a day of doing outpatient sedation at Sparrow Hospital in Lansing. It was December and Michigan-cold. The roads were fine – no snow – but I noticed an unusual amount of traffic on the freeway. Then I saw smoke coming from an overpass up ahead.

I drove on the side of the road where I wasn’t really supposed to and got closer. An SUV had crashed into one of the big concrete structures under the bridge. I saw people running around but wasn’t able to spot EMS or any health care workers. From where I was, I could identify four kids who had already been extricated and one adult still in the driver’s seat. I estimated the kids’ ages were around 7, 5, 3, and an infant who was a few months old. I left my car and went to help.

I was able to peg the ages correctly because I’m a pediatric critical care physician. As a specialty, we’re not commonly known. We oversee patient care in intensive care units, except the patients are children. Part of the job is that we’re experts at triaging. We recognize what’s life-threatening and less so.

The kids were with some adults who kept them warm with blankets. I examined each of them. The infant was asleep but arousable and acting like a normal baby. The 3-year-old boy was vomiting and appeared very fatigued. The 5-year-old boy had a forehead laceration and was in and out of consciousness. The 7-year-old girl was screaming because of different injuries.

While all of the children were concerning to me, I identified one in particular: the 5-year-old boy. It was obvious he needed serious medical attention and fast. So, I kept that little guy in mind. The others had sustained significant injuries, but my best guess was they could get to a hospital and be stabilized.

That said, I’m a trauma instructor, and one of the things I always tell trainees is: Trauma is a black box. On the outside, it may seem like a patient doesn’t have a lot of injuries. But underneath, there might be something worse, like a brain injury. Or the chest might have taken a blunt impact affecting the heart. There may be internal bleeding somewhere in the belly. It’s really hard to tease out what exactly is going on without equipment and testing.

I didn’t even have a pulse oximeter or heart rate monitor. I pretty much just went by the appearance of the child: pulse, heart rate, awareness, things like that.

After the kids, I moved to look at the man in the car. The front end had already caught fire. I could see the driver – the kids’ father, I guessed – unconscious and hunched over. I was wondering, Why hasn’t this guy been extricated?

I approached the car on the front passenger side. And then I just had this feeling. I knew I needed to step back. Immediately.

I did. And a few seconds later, the whole car exploded in flames.

I believe God is in control of everything. I tried to get to that man. But the scene was unsafe. Later I learned that several people, including a young nurse at the scene, had tried to get to him as well.

When EMS came, I identified myself. Obviously, these people do very, very important work. But they may be more used to the 60-year-old heart attack, the 25-year-old gunshot wound, the occasional ill child. I thought that four kids – each with possible critical poly-traumatic injuries – posed a challenge to anyone.

I told them, “This is what I do on a daily basis, and this is the kid I’m worried about the most. The other kids are definitely worrisome, but I would prioritize getting this kid to the hospital first. Can I ride with you?” They agreed.

We got that boy and his older sister into the first ambulance (she was in a lot of pain, the result of a femur fracture). The two other kids rode in the second ambulance. The hospital where I had just left was 10 minutes away. I called the other pediatric critical care doctor there, my partner. He thought I was calling for a routine issue – no such luck. I said, “I’m with four kids who are level-1 traumas in two ambulances and I’m heading to the hospital right now, ETA 10 minutes.”

En route, I thought the little boy might lose consciousness at any moment. He needed a breathing tube, and I debated whether it should be done in the ambulance vs. waiting until we got to the emergency room. Based on my judgment and his vital signs, I elected to wait to have it done it in a more controlled environment. Had I felt like he was in immediate need of an airway, I would’ve attempted it. But those are the tough calls that you must make.

My partner had alerted the trauma and emergency medicine teams at the hospital. By the time we arrived, my partner was down in the ER with the trauma team and ER staff. Everyone was ready. Then it was like divide and conquer. He attended to one of the kids. The ER team and I were with the little guy I was really worried about. We had his breathing tube in within minutes. The trauma team attended to the other two.

All the kids were stabilized and then admitted to the pediatric intensive care unit. I’m happy to say that all of them did well in the end. Even the little guy I was worried about the most.

I must say this incident gave me perspective on what EMS goes through. The field medicine we do in the United States is still in its infancy in a lot of ways. One of the things I would love to see in the future is a mobile ICU. After a critical illness hits, sometimes you only have seconds, minutes, maybe hours if you’re lucky. The earlier you can get patients the treatment they need, the better the outcomes.

I like taking care of critically ill children and their families. It fits my personality. And it’s a wonderful cause. But you have to be ready for tragic cases like this one. Yes, the children came out alive, but the accident claimed a life in a horrible way. And there was nothing I could do about it.

Critical care takes an emotional, psychological, and physical toll. It’s a roller coaster: Some kids do well; some kids don’t do well. All I can do is hold myself accountable. I keep my emotions in check, whether the outcome is positive or negative. And I do my best.
 

Mohamed Hani Farhat, MD, is a pediatric critical care physician at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor and Sparrow Hospital in Lansing, Mich. Are you a physician with a dramatic medical story outside the clinic? Medscape would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary of your story to [email protected] . A version of this article appeared on Medscape.com.

Emergencies happen anywhere, anytime, and sometimes physicians find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape series telling these stories.

I was coming off a 48-hour shift plus a day of doing outpatient sedation at Sparrow Hospital in Lansing. It was December and Michigan-cold. The roads were fine – no snow – but I noticed an unusual amount of traffic on the freeway. Then I saw smoke coming from an overpass up ahead.

I drove on the side of the road where I wasn’t really supposed to and got closer. An SUV had crashed into one of the big concrete structures under the bridge. I saw people running around but wasn’t able to spot EMS or any health care workers. From where I was, I could identify four kids who had already been extricated and one adult still in the driver’s seat. I estimated the kids’ ages were around 7, 5, 3, and an infant who was a few months old. I left my car and went to help.

I was able to peg the ages correctly because I’m a pediatric critical care physician. As a specialty, we’re not commonly known. We oversee patient care in intensive care units, except the patients are children. Part of the job is that we’re experts at triaging. We recognize what’s life-threatening and less so.

The kids were with some adults who kept them warm with blankets. I examined each of them. The infant was asleep but arousable and acting like a normal baby. The 3-year-old boy was vomiting and appeared very fatigued. The 5-year-old boy had a forehead laceration and was in and out of consciousness. The 7-year-old girl was screaming because of different injuries.

While all of the children were concerning to me, I identified one in particular: the 5-year-old boy. It was obvious he needed serious medical attention and fast. So, I kept that little guy in mind. The others had sustained significant injuries, but my best guess was they could get to a hospital and be stabilized.

That said, I’m a trauma instructor, and one of the things I always tell trainees is: Trauma is a black box. On the outside, it may seem like a patient doesn’t have a lot of injuries. But underneath, there might be something worse, like a brain injury. Or the chest might have taken a blunt impact affecting the heart. There may be internal bleeding somewhere in the belly. It’s really hard to tease out what exactly is going on without equipment and testing.

I didn’t even have a pulse oximeter or heart rate monitor. I pretty much just went by the appearance of the child: pulse, heart rate, awareness, things like that.

After the kids, I moved to look at the man in the car. The front end had already caught fire. I could see the driver – the kids’ father, I guessed – unconscious and hunched over. I was wondering, Why hasn’t this guy been extricated?

I approached the car on the front passenger side. And then I just had this feeling. I knew I needed to step back. Immediately.

I did. And a few seconds later, the whole car exploded in flames.

I believe God is in control of everything. I tried to get to that man. But the scene was unsafe. Later I learned that several people, including a young nurse at the scene, had tried to get to him as well.

When EMS came, I identified myself. Obviously, these people do very, very important work. But they may be more used to the 60-year-old heart attack, the 25-year-old gunshot wound, the occasional ill child. I thought that four kids – each with possible critical poly-traumatic injuries – posed a challenge to anyone.

I told them, “This is what I do on a daily basis, and this is the kid I’m worried about the most. The other kids are definitely worrisome, but I would prioritize getting this kid to the hospital first. Can I ride with you?” They agreed.

We got that boy and his older sister into the first ambulance (she was in a lot of pain, the result of a femur fracture). The two other kids rode in the second ambulance. The hospital where I had just left was 10 minutes away. I called the other pediatric critical care doctor there, my partner. He thought I was calling for a routine issue – no such luck. I said, “I’m with four kids who are level-1 traumas in two ambulances and I’m heading to the hospital right now, ETA 10 minutes.”

En route, I thought the little boy might lose consciousness at any moment. He needed a breathing tube, and I debated whether it should be done in the ambulance vs. waiting until we got to the emergency room. Based on my judgment and his vital signs, I elected to wait to have it done it in a more controlled environment. Had I felt like he was in immediate need of an airway, I would’ve attempted it. But those are the tough calls that you must make.

My partner had alerted the trauma and emergency medicine teams at the hospital. By the time we arrived, my partner was down in the ER with the trauma team and ER staff. Everyone was ready. Then it was like divide and conquer. He attended to one of the kids. The ER team and I were with the little guy I was really worried about. We had his breathing tube in within minutes. The trauma team attended to the other two.

All the kids were stabilized and then admitted to the pediatric intensive care unit. I’m happy to say that all of them did well in the end. Even the little guy I was worried about the most.

I must say this incident gave me perspective on what EMS goes through. The field medicine we do in the United States is still in its infancy in a lot of ways. One of the things I would love to see in the future is a mobile ICU. After a critical illness hits, sometimes you only have seconds, minutes, maybe hours if you’re lucky. The earlier you can get patients the treatment they need, the better the outcomes.

I like taking care of critically ill children and their families. It fits my personality. And it’s a wonderful cause. But you have to be ready for tragic cases like this one. Yes, the children came out alive, but the accident claimed a life in a horrible way. And there was nothing I could do about it.

Critical care takes an emotional, psychological, and physical toll. It’s a roller coaster: Some kids do well; some kids don’t do well. All I can do is hold myself accountable. I keep my emotions in check, whether the outcome is positive or negative. And I do my best.
 

Mohamed Hani Farhat, MD, is a pediatric critical care physician at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor and Sparrow Hospital in Lansing, Mich. Are you a physician with a dramatic medical story outside the clinic? Medscape would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary of your story to [email protected] . A version of this article appeared on Medscape.com.

About half a million children between the ages of 1 and 3 years old have ear tube surgery in the United States every year at an annual cost exceeding $2 billion. It is the most common childhood surgery performed with anesthesia. It is a surgery commonly performed on children in most other high- and middle-income countries.

My group recently published a paper on the timing and necessity of tympanostomy tubes for recurrent otitis media in young children. The primary objective was to quantitatively examine recurrent acute otitis media (AOM) incidence with respect to age of occurrence, the influence of daycare attendance, and other risk factors in individual children. We introduced the concept of a “window of susceptibility” to AOM as new terminology referring to a child who has two or more closely spaced AOM occurrences during a window of time. We sought to know what to expect and how to advise the parent when a child presents with closely spaced AOMs.

A secondary objective was to develop models to predict the risk and timing of AOM recurrences based on the natural history of disease in young children who do not get tympanostomy tubes. Prediction models were developed to assist clinicians in understanding and explaining to parents the benefit of tympanostomy tubes based on the child’s age and number of AOMs.

The children were all from a primary care pediatric practice in Rochester, N.Y., which comprised a typical mixed demographic of largely middle-class, health care–insured families that was broadly representative of the racial/ethnic diversity in the community. The sample included both wealthy families and those living below the poverty line. The diagnosis of AOM was made based on the American Academy of Pediatrics guidance in which a presumed middle ear effusion and a full or bulging tympanic membrane were required. Almost all episodes (> 85%) of clinically diagnosed AOM cases were confirmed by culture of middle ear fluid collected by tympanocentesis to ensure diagnostic accuracy.

286 children who had ear infections were studied. We found that 80% of ear infections occurred during a very narrow window of susceptibility – age 6-21 months. About 72% of children had a window of susceptibility to ear infections that lasted 5 months or less; 97% of children had a window of susceptibility that lasted 10 months or less.

From this result, we observed that about 90% of children have a window of time lasting about 10 months when they get repeated ear infections. By the time a child gets three ear infections in 6 months (a period of time recommended by the AAP and American Academy of Otolaryngology–Head and Neck Surgery when ear tubes might be considered) and then a referral for ear tubes is made and the child gets an appointment with the ear, nose, and throat doctor, and surgery is scheduled, the ear infections were going to stop anyway.

In other words, millions of children worldwide have been getting ear tubes and physicians and parents saw that the ear infections stopped. So they concluded the ear tubes stopped the infections. We found the infections were going to stop anyway even if the child did not receive ear tubes because their susceptibility to ear infections is over by the time the surgery is performed. The child outgrew ear infections.

An exception was children in daycare at an early age. Our study found that children in daycare who are around 6 months old and start getting ear infections at that age are likely destined to have three or more ear infections in the first year of life. If children are going to be in daycare, perhaps those who need them should receive ear tubes early. Analysis of other demographic and risk factor covariates – sex, race/ethnicity, breastfeeding, siblings in the home, smoking in the home, atopy, and family history of otitis media – were not significantly associated with the number of AOMs in the child population we studied.

We developed a prediction model for doctors, so they could input a child’s age, number of ear infections, and daycare attendance and receive back an estimate of the number of likely future ear infections for that child. With that knowledge, physicians and parents can make more informed decisions.

Our message to clinicians and parents is to reconsider the necessity and timing of ear tube surgery for children with recurrent ear infections because the future is not predicted by the past. Children having several ear infections in a short time does not predict that they will have a similar number of ear infections in the future.

The study was supported by the National Institutes of Health awarded to Rochester Regional Health. Dr. Pichichero was principal investigator for the award.

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

About half a million children between the ages of 1 and 3 years old have ear tube surgery in the United States every year at an annual cost exceeding $2 billion. It is the most common childhood surgery performed with anesthesia. It is a surgery commonly performed on children in most other high- and middle-income countries.

My group recently published a paper on the timing and necessity of tympanostomy tubes for recurrent otitis media in young children. The primary objective was to quantitatively examine recurrent acute otitis media (AOM) incidence with respect to age of occurrence, the influence of daycare attendance, and other risk factors in individual children. We introduced the concept of a “window of susceptibility” to AOM as new terminology referring to a child who has two or more closely spaced AOM occurrences during a window of time. We sought to know what to expect and how to advise the parent when a child presents with closely spaced AOMs.

A secondary objective was to develop models to predict the risk and timing of AOM recurrences based on the natural history of disease in young children who do not get tympanostomy tubes. Prediction models were developed to assist clinicians in understanding and explaining to parents the benefit of tympanostomy tubes based on the child’s age and number of AOMs.

The children were all from a primary care pediatric practice in Rochester, N.Y., which comprised a typical mixed demographic of largely middle-class, health care–insured families that was broadly representative of the racial/ethnic diversity in the community. The sample included both wealthy families and those living below the poverty line. The diagnosis of AOM was made based on the American Academy of Pediatrics guidance in which a presumed middle ear effusion and a full or bulging tympanic membrane were required. Almost all episodes (> 85%) of clinically diagnosed AOM cases were confirmed by culture of middle ear fluid collected by tympanocentesis to ensure diagnostic accuracy.

286 children who had ear infections were studied. We found that 80% of ear infections occurred during a very narrow window of susceptibility – age 6-21 months. About 72% of children had a window of susceptibility to ear infections that lasted 5 months or less; 97% of children had a window of susceptibility that lasted 10 months or less.

From this result, we observed that about 90% of children have a window of time lasting about 10 months when they get repeated ear infections. By the time a child gets three ear infections in 6 months (a period of time recommended by the AAP and American Academy of Otolaryngology–Head and Neck Surgery when ear tubes might be considered) and then a referral for ear tubes is made and the child gets an appointment with the ear, nose, and throat doctor, and surgery is scheduled, the ear infections were going to stop anyway.

In other words, millions of children worldwide have been getting ear tubes and physicians and parents saw that the ear infections stopped. So they concluded the ear tubes stopped the infections. We found the infections were going to stop anyway even if the child did not receive ear tubes because their susceptibility to ear infections is over by the time the surgery is performed. The child outgrew ear infections.

An exception was children in daycare at an early age. Our study found that children in daycare who are around 6 months old and start getting ear infections at that age are likely destined to have three or more ear infections in the first year of life. If children are going to be in daycare, perhaps those who need them should receive ear tubes early. Analysis of other demographic and risk factor covariates – sex, race/ethnicity, breastfeeding, siblings in the home, smoking in the home, atopy, and family history of otitis media – were not significantly associated with the number of AOMs in the child population we studied.

We developed a prediction model for doctors, so they could input a child’s age, number of ear infections, and daycare attendance and receive back an estimate of the number of likely future ear infections for that child. With that knowledge, physicians and parents can make more informed decisions.

Our message to clinicians and parents is to reconsider the necessity and timing of ear tube surgery for children with recurrent ear infections because the future is not predicted by the past. Children having several ear infections in a short time does not predict that they will have a similar number of ear infections in the future.

The study was supported by the National Institutes of Health awarded to Rochester Regional Health. Dr. Pichichero was principal investigator for the award.

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

About half a million children between the ages of 1 and 3 years old have ear tube surgery in the United States every year at an annual cost exceeding $2 billion. It is the most common childhood surgery performed with anesthesia. It is a surgery commonly performed on children in most other high- and middle-income countries.

My group recently published a paper on the timing and necessity of tympanostomy tubes for recurrent otitis media in young children. The primary objective was to quantitatively examine recurrent acute otitis media (AOM) incidence with respect to age of occurrence, the influence of daycare attendance, and other risk factors in individual children. We introduced the concept of a “window of susceptibility” to AOM as new terminology referring to a child who has two or more closely spaced AOM occurrences during a window of time. We sought to know what to expect and how to advise the parent when a child presents with closely spaced AOMs.

A secondary objective was to develop models to predict the risk and timing of AOM recurrences based on the natural history of disease in young children who do not get tympanostomy tubes. Prediction models were developed to assist clinicians in understanding and explaining to parents the benefit of tympanostomy tubes based on the child’s age and number of AOMs.

The children were all from a primary care pediatric practice in Rochester, N.Y., which comprised a typical mixed demographic of largely middle-class, health care–insured families that was broadly representative of the racial/ethnic diversity in the community. The sample included both wealthy families and those living below the poverty line. The diagnosis of AOM was made based on the American Academy of Pediatrics guidance in which a presumed middle ear effusion and a full or bulging tympanic membrane were required. Almost all episodes (> 85%) of clinically diagnosed AOM cases were confirmed by culture of middle ear fluid collected by tympanocentesis to ensure diagnostic accuracy.

286 children who had ear infections were studied. We found that 80% of ear infections occurred during a very narrow window of susceptibility – age 6-21 months. About 72% of children had a window of susceptibility to ear infections that lasted 5 months or less; 97% of children had a window of susceptibility that lasted 10 months or less.

From this result, we observed that about 90% of children have a window of time lasting about 10 months when they get repeated ear infections. By the time a child gets three ear infections in 6 months (a period of time recommended by the AAP and American Academy of Otolaryngology–Head and Neck Surgery when ear tubes might be considered) and then a referral for ear tubes is made and the child gets an appointment with the ear, nose, and throat doctor, and surgery is scheduled, the ear infections were going to stop anyway.

In other words, millions of children worldwide have been getting ear tubes and physicians and parents saw that the ear infections stopped. So they concluded the ear tubes stopped the infections. We found the infections were going to stop anyway even if the child did not receive ear tubes because their susceptibility to ear infections is over by the time the surgery is performed. The child outgrew ear infections.

An exception was children in daycare at an early age. Our study found that children in daycare who are around 6 months old and start getting ear infections at that age are likely destined to have three or more ear infections in the first year of life. If children are going to be in daycare, perhaps those who need them should receive ear tubes early. Analysis of other demographic and risk factor covariates – sex, race/ethnicity, breastfeeding, siblings in the home, smoking in the home, atopy, and family history of otitis media – were not significantly associated with the number of AOMs in the child population we studied.

We developed a prediction model for doctors, so they could input a child’s age, number of ear infections, and daycare attendance and receive back an estimate of the number of likely future ear infections for that child. With that knowledge, physicians and parents can make more informed decisions.

Our message to clinicians and parents is to reconsider the necessity and timing of ear tube surgery for children with recurrent ear infections because the future is not predicted by the past. Children having several ear infections in a short time does not predict that they will have a similar number of ear infections in the future.

The study was supported by the National Institutes of Health awarded to Rochester Regional Health. Dr. Pichichero was principal investigator for the award.

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.

All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.

“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.

In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.

“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.

The draft recommendation statement was published online .
 

Screening recommendation

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.

The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.

After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”

The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.

Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.

In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.

Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.

Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.

“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
 

Additional considerations

The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.

Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.

Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.

The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.

“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”

The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.

No relevant financial relationships have been disclosed.

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

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.

All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.

“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.

In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.

“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.

The draft recommendation statement was published online .
 

Screening recommendation

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.

The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.

After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”

The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.

Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.

In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.

Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.

Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.

“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
 

Additional considerations

The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.

Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.

Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.

The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.

“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”

The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.

No relevant financial relationships have been disclosed.

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

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.

All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.

“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.

In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.

“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.

The draft recommendation statement was published online .
 

Screening recommendation

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.

The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.

After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”

The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.

Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.

In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.

Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.

Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.

“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
 

Additional considerations

The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.

Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.

Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.

The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.

“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”

The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.

No relevant financial relationships have been disclosed.

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