Federal Practitioner

Muscle-related complaints occur in 7% to 25% of patients taking statin medications.¹ In most instances, these adverse effects are quickly resolved when the medication is discontinued, but in rare occurrences, the statin can trigger an autoimmune response that progresses even after stopping use. This uncommon condition is typically accompanied by symmetrical proximal muscle weakness and an elevated CPK leading to a necrotizing myopathy requiring treatment with immunosuppressive therapy. Although less common, some patients may also present with dysphagia, myalgia, weight loss, and/or skin rash.¹

Statin medications have been the cornerstone of lipid-lowering therapy due to their mechanism of inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), which is the rate-limiting step within the cholesterol synthesis pathway to produce mevalonic acid. There is a proven genetic association with human leukocyte antigen (HLA)-DRB1*11:01 in adults and anti-HMGCR–associated myopathy.¹ The incidence of statin-induced necrotizing autoimmune myopathy (SINAM) in relation to each specific statin agent remains unknown; however, a systematic review of case reports found higher correlations for atorvastatin and simvastatin.²

There are 2 ways to confirm a SINAM diagnosis. The first and simplest includes checking for the presence of antibodies against HMGCR. The anti-HMGCR antibody test is typically used as a definitive diagnosis because it has a high specificity for SINAM.³ The second and more invasive diagnosis method involves a muscle biopsy, which is identified as positive if the biopsy shows the presence of necrotic muscle fibers.^1,3

The anti-HMGCR antibody test can serve as a marker for disease activity because the antibodies are strongly correlated with CPK levels.¹ CPK levels indicate the severity of muscle injury and is often used in addition to either of the confirmatory tests because it is faster and less expensive. Anti-HMGCR titers may remain positive while CPK returns to baseline when SINAM is dormant. In addition, clinicians may use an electromyography (EMG) test to measure the muscle response in association to nerve stimulation. ¹ This test can show potential features of myopathic lesions such as positive sharp waves, spontaneous fibrillations, or myotonic repetitive potentials.

Typical treatment includes glucocorticoids as first-line agents, but SINAM can be difficult to treat due to its complicated pathophysiology processes.³ Escalation of therapy is sometimes required beyond a single agent; in these complex scenarios, methotrexate and/or intravenous (IV) immunoglobulin (IVIG) therapy are frequently added to the steroid therapy. There have been concerns with steroid use in specific patient populations due to the undesired adverse effect (AE) profile, and as a result IVIG has been used as monotherapy at a dose of 2 g/kg per month.³ Studies looking at IVIG monotherapy showed a reduction in CPK levels and improvement in strength after just 2 to 3 rounds of monthly treatment.³ Some patients receiving IVIG monotherapy even achieved baseline strength and no longer reported muscle-related symptoms, although the total treatment duration varied. A systematic review of 39 articles where glucocorticoids, IVIG, methotrexate and/or a combination were used to treat SINAM found an average time to remission of 8.6 months. Additionally, this systematic review observed more patients returned to baseline or experienced improvement in symptoms when being treated with a combination of glucocorticoid plus IVIG plus methotrexate.² Suggested dosing recommendations are available in Table 1.

Patients diagnosed with HMGCR antibody myopathy are contraindicated for future statin therapy.¹ Rechallenge of statins in this patient population has led to worsening of disease and therefore these patients should have a severe statin allergy listed in their medical documentation record.

CASE PRESENTATION

A 59-year-old male patient with a medical history including atrial fibrillation, peripheral vascular disease, type 2 diabetes mellitus (T2DM), hypertension, and peripheral neuropathy was referred by his primary care clinical pharmacist practitioner for an outpatient neurology consult. The patient reported a 4-month history of fatigue, lower extremity paresthesia, and progressive proximal muscle weakness which began in his legs, mostly noticeable when walking upstairs but quickly developed into bilateral arm weakness. The patient reported significant impact on his quality of life: he could no longer lift his arms above his head and had difficulty with daily activities such as brushing his hair or getting up from a chair. He reported multiple falls at home, and began to use a cane for assistance with ambulation. He confirmed adherence to atorvastatin over the past year. Laboratory testing on the day of the visit revealed an elevated CPK level at 9729 mcg/L (reference range for men, 30-300 mcg/L).

The patient was urged to go to the emergency department where his CPK level had increased to 12,990 mcg/L (Figure 1). The workup began to find the source of rhabdomyolysis and elevated liver enzymes differentiating autoimmune vs medication-induced myopathy. Upon admission atorvastatin was discontinued, anti-HMGCR antibody level was ordered, and IV fluids were started.

After 8 days of hospital admission with minimal improvement, Rheumatology and Neurology services were consulted in the setting of persistent CPK elevation and the potential neuropathic component of muscle weakness. Both consulting services agreed to consider muscle biopsy and EMG if the patient did not begin to show signs of improvement. The patient’s CPK levels remained elevated with minimal change in muscle weakness. The next step was a right quadricep muscle biopsy performed on Day 14 of admission. Sixteen days after admission, the anti-HMGCR antibody test (originally obtained upon admission) was positive and elevated at 249 CU/mL (reference range, < 20 CU/mL negative; reference range, ≥ 60 CU/mL strong positive), which confirmed the SINAM diagnosis (Table 2).

On Day 17 of hospitalization, the Neurology service initiated IVIG monotherapy to avoid the undesired glycemic AEs associated with glucocorticoids. The patient had a history of T2DM that was difficult to manage and his hemoglobin A_1c level was the best it had ever been (6.2%) relative to a peak A_1c of 11.0% 9 months prior. The patient was treated with a total IVIG dose of 2 g/kg divided into 3 daily doses while still obtaining CPK levels with daily laboratory tests to assist with trending the extent of disease severity improvement (Figures 2-4). After a 20-day hospital stay, the patient was discharged home with rehabilitation services and a scheduled outpatient EMG the following week.

The patient continued to report generalized body weakness, pain, and deconditioning upon discharge and was unable to attend the EMG neurology appointment. The patient did eventually attend a follow-up appointment about 6 weeks after hospital discharge and reported continued weakness. The Neurology service prescribed a 2-day IVIG regimen (total dose = 2 g/kg) monthly for the next 2 months. The patient returned to the neurology clinic 8 weeks later following 2 rounds of IVIG posthospitalization and reported that his muscle strength was returning, and he was able to slowly reintroduce exercise into his daily routine. During a follow-up appointment about 11 months after the initial hospitalization, the patient’s primary care clinical pharmacist provided education of effective management of cholesterol without statins, including use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors as recommended by the Neurology service. At this time, the patient’s calculated low-density lipoprotein (LDL) was 110 mg/dL (reference range, 0-99 mg/dL). The patient preferred to work on a healthy diet and positive lifestyle choices before trialing any lipid lowering therapies.

The patient appeared to tolerate this treatment regimen following 7 rounds of IVIG. He noted fatigue for about 24 hours after his infusion sessions but otherwise reported no additional AEs. He has continued to attend weekly physical therapy sessions and is able to walk without the assistance of a cane. He can now walk a mile before he begins to feel fatigued or experience bilateral lower leg pain. The pain appears neuropathic in nature, as the patient reports ongoing “pins and needles” sensation in his legs and feet. The patient has noticed a major improvement in his overall function, strength, and exercise tolerance since starting IVIG treatments and although he is not yet back to his baseline, he is motivated to continue his recovery. Neurology is considering ongoing treatment with IVIG monthly infusions given his continued clinical improvement.

DISCUSSION

There is limited evidence on the use of IVIG monotherapy for SINAM, although it may be a viable option for patients deemed poor candidates for glucocorticoid or methotrexate therapy. This particularly applies to patients with DM for which there may be concerns for managing blood glucose levels with steroid use. The Johns Hopkins Myositis Center evaluated 3 patients with SINAM who declined glucocorticoid therapy and had documented DM and weakness in the proximal arms and legs. Following 2 to 3 monthly rounds of IVIG 2 g/kg monotherapy, these patients had reduced CPK levels and had improvement in both arm and hip-flexion strength. Two patients reported no muscle-related symptoms after completing IVIG monotherapy treatment for 9 and 19 months.³

The optimal treatment duration for IVIG monotherapy for SINAM is still uncertain given the limited available data. The patient in this case report showed clinically significant muscle-related improvement following 7 monthly rounds of 2 g/kg IVIG treatments. The mechanism of action for IVIG in this setting is still unknown, although the medication may allow muscle regeneration to surpass muscle destruction, thus leading to resolution of the muscle-related symptoms.³

There are numerous concerns with IVIG use to consider prior to initiating treatment, including expense, AEs, patient response, and comorbidities. IVIG is considerably more expensive than glucocorticoid and methotrexate alternatives. Systemic reactions have been shown to occur in 5% to 15% of patients receiving IVIG infusion.⁴ The majority of these infusion reactions occur early during infusion or within a few hours after administration is complete.⁵ Early AEs to monitor for include injection site reactions, flu-like symptoms, dermatologic reactions, anaphylaxis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Additional AEs may be delayed, including thromboembolic events, acute kidney injury, aseptic meningitis, hemolysis, neutropenia, and blood-borne infection.⁶ IVIG has a boxed warning for thrombosis, renal dysfunction, and acute renal failure risk.⁷ There are multiple strategies documented to reduce the risk of IVIG reactions including slowing the infusion rate, ensuring adequate hydration, and/or giving analgesics, antihistamines, or steroids prior to infusion.⁶ The patient in this case had monthly IVIG infusions without the need of any pretreatment medications and only reported fatigue for about 24 hours following the infusion.

An essential question is how to provide safe cholesterol management for patients with SINAM. Some evidence has suggested that other lipid-lowering medications that avoid the mevalonate pathway, such as fenofibrate or ezetimibe, may be used cautiously initially at lower doses.¹ Due to the severity of SINAM, it is crucial to closely monitor and ensure tolerability as new lipid-lowering agents are introduced. More evidence suggests that PCSK9 inhibitors are a safer option.⁸ PCSK9 inhibitors avoid the mevalonate pathway and block PCSK9 from binding to LDL receptors, allowing LDL to be removed from circulation.

Tiniakou et al followed 8 individuals for a mean 1.5 years who had anti-HMGCR immune-mediated myopathy at high cardiovascular risk. Muscle strength, CPK levels, and serum anti-HMGCR antibody titers were assessed at baseline and again after initiation of PCSK9 inhibitor. None of the patients experienced a decline in their muscle strength. CPK, anti-HMGCR antibody levels, and LDL trended down in all participants and 2 patients were able to reduce their immunosuppression treatment while still achieving clinical improvement. Tiniakou et al suggest that PCSK9 inhibitors are a safe and effective option to lower cholesterol in patients with SINAM.⁸

Alirocumab is the preferred PCSK9 inhibitor for patients at the US Department of Veterans Affairs (VA). The VA Pharmacy Benefits Management (PBM) Service guidance recommends alirocumab for patients with a history of atherosclerotic cardiovascular disease (ASCVD) or severe hypercholesterolemia.⁹ PBM guidance suggests alirocumab use for patients with a contraindication, intolerance, or insufficient LDL reduction with a maximally tolerated dose of statin and ezetimibe with a desire to reduce ASCVD risk by lowering LDL. Per the PBM Criteria for Use guidance, patients should follow the stepwise approach and trial ezetimibe prior to being considered for PCSK9 inhibitor therapy. Given the patient’s contraindication to future statin use and severity of myopathy, in this case the Neurology Service felt that the safest option to reach goal LDL reduction would be a PCSK9 inhibitor. Consideration can be made for alirocumab use when considering an alternative lipid lowering therapy.

CONCLUSIONS

This report demonstrates a case of SINAM caused by atorvastatin therapy. Patients presenting with proximal muscle weakness and elevated CPK even after statin discontinuation should be considered for a full workup to determine whether SINAM may be involved. This uncommon form of myopathy can be diagnosed based on the detection of anti-HMGCR antibodies and/or presence of necrosis on muscle biopsy. A combination of glucocorticoid, methotrexate, and IVIG is recommended for a patient’s best chance of muscle symptom improvement. IVIG monotherapy should be considered for patients with glycemic control concerns.

Muscle-related complaints occur in 7% to 25% of patients taking statin medications.¹ In most instances, these adverse effects are quickly resolved when the medication is discontinued, but in rare occurrences, the statin can trigger an autoimmune response that progresses even after stopping use. This uncommon condition is typically accompanied by symmetrical proximal muscle weakness and an elevated CPK leading to a necrotizing myopathy requiring treatment with immunosuppressive therapy. Although less common, some patients may also present with dysphagia, myalgia, weight loss, and/or skin rash.¹

Statin medications have been the cornerstone of lipid-lowering therapy due to their mechanism of inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), which is the rate-limiting step within the cholesterol synthesis pathway to produce mevalonic acid. There is a proven genetic association with human leukocyte antigen (HLA)-DRB1*11:01 in adults and anti-HMGCR–associated myopathy.¹ The incidence of statin-induced necrotizing autoimmune myopathy (SINAM) in relation to each specific statin agent remains unknown; however, a systematic review of case reports found higher correlations for atorvastatin and simvastatin.²

There are 2 ways to confirm a SINAM diagnosis. The first and simplest includes checking for the presence of antibodies against HMGCR. The anti-HMGCR antibody test is typically used as a definitive diagnosis because it has a high specificity for SINAM.³ The second and more invasive diagnosis method involves a muscle biopsy, which is identified as positive if the biopsy shows the presence of necrotic muscle fibers.^1,3

The anti-HMGCR antibody test can serve as a marker for disease activity because the antibodies are strongly correlated with CPK levels.¹ CPK levels indicate the severity of muscle injury and is often used in addition to either of the confirmatory tests because it is faster and less expensive. Anti-HMGCR titers may remain positive while CPK returns to baseline when SINAM is dormant. In addition, clinicians may use an electromyography (EMG) test to measure the muscle response in association to nerve stimulation. ¹ This test can show potential features of myopathic lesions such as positive sharp waves, spontaneous fibrillations, or myotonic repetitive potentials.

Typical treatment includes glucocorticoids as first-line agents, but SINAM can be difficult to treat due to its complicated pathophysiology processes.³ Escalation of therapy is sometimes required beyond a single agent; in these complex scenarios, methotrexate and/or intravenous (IV) immunoglobulin (IVIG) therapy are frequently added to the steroid therapy. There have been concerns with steroid use in specific patient populations due to the undesired adverse effect (AE) profile, and as a result IVIG has been used as monotherapy at a dose of 2 g/kg per month.³ Studies looking at IVIG monotherapy showed a reduction in CPK levels and improvement in strength after just 2 to 3 rounds of monthly treatment.³ Some patients receiving IVIG monotherapy even achieved baseline strength and no longer reported muscle-related symptoms, although the total treatment duration varied. A systematic review of 39 articles where glucocorticoids, IVIG, methotrexate and/or a combination were used to treat SINAM found an average time to remission of 8.6 months. Additionally, this systematic review observed more patients returned to baseline or experienced improvement in symptoms when being treated with a combination of glucocorticoid plus IVIG plus methotrexate.² Suggested dosing recommendations are available in Table 1.

Patients diagnosed with HMGCR antibody myopathy are contraindicated for future statin therapy.¹ Rechallenge of statins in this patient population has led to worsening of disease and therefore these patients should have a severe statin allergy listed in their medical documentation record.

CASE PRESENTATION

A 59-year-old male patient with a medical history including atrial fibrillation, peripheral vascular disease, type 2 diabetes mellitus (T2DM), hypertension, and peripheral neuropathy was referred by his primary care clinical pharmacist practitioner for an outpatient neurology consult. The patient reported a 4-month history of fatigue, lower extremity paresthesia, and progressive proximal muscle weakness which began in his legs, mostly noticeable when walking upstairs but quickly developed into bilateral arm weakness. The patient reported significant impact on his quality of life: he could no longer lift his arms above his head and had difficulty with daily activities such as brushing his hair or getting up from a chair. He reported multiple falls at home, and began to use a cane for assistance with ambulation. He confirmed adherence to atorvastatin over the past year. Laboratory testing on the day of the visit revealed an elevated CPK level at 9729 mcg/L (reference range for men, 30-300 mcg/L).

The patient was urged to go to the emergency department where his CPK level had increased to 12,990 mcg/L (Figure 1). The workup began to find the source of rhabdomyolysis and elevated liver enzymes differentiating autoimmune vs medication-induced myopathy. Upon admission atorvastatin was discontinued, anti-HMGCR antibody level was ordered, and IV fluids were started.

After 8 days of hospital admission with minimal improvement, Rheumatology and Neurology services were consulted in the setting of persistent CPK elevation and the potential neuropathic component of muscle weakness. Both consulting services agreed to consider muscle biopsy and EMG if the patient did not begin to show signs of improvement. The patient’s CPK levels remained elevated with minimal change in muscle weakness. The next step was a right quadricep muscle biopsy performed on Day 14 of admission. Sixteen days after admission, the anti-HMGCR antibody test (originally obtained upon admission) was positive and elevated at 249 CU/mL (reference range, < 20 CU/mL negative; reference range, ≥ 60 CU/mL strong positive), which confirmed the SINAM diagnosis (Table 2).

On Day 17 of hospitalization, the Neurology service initiated IVIG monotherapy to avoid the undesired glycemic AEs associated with glucocorticoids. The patient had a history of T2DM that was difficult to manage and his hemoglobin A_1c level was the best it had ever been (6.2%) relative to a peak A_1c of 11.0% 9 months prior. The patient was treated with a total IVIG dose of 2 g/kg divided into 3 daily doses while still obtaining CPK levels with daily laboratory tests to assist with trending the extent of disease severity improvement (Figures 2-4). After a 20-day hospital stay, the patient was discharged home with rehabilitation services and a scheduled outpatient EMG the following week.

The patient continued to report generalized body weakness, pain, and deconditioning upon discharge and was unable to attend the EMG neurology appointment. The patient did eventually attend a follow-up appointment about 6 weeks after hospital discharge and reported continued weakness. The Neurology service prescribed a 2-day IVIG regimen (total dose = 2 g/kg) monthly for the next 2 months. The patient returned to the neurology clinic 8 weeks later following 2 rounds of IVIG posthospitalization and reported that his muscle strength was returning, and he was able to slowly reintroduce exercise into his daily routine. During a follow-up appointment about 11 months after the initial hospitalization, the patient’s primary care clinical pharmacist provided education of effective management of cholesterol without statins, including use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors as recommended by the Neurology service. At this time, the patient’s calculated low-density lipoprotein (LDL) was 110 mg/dL (reference range, 0-99 mg/dL). The patient preferred to work on a healthy diet and positive lifestyle choices before trialing any lipid lowering therapies.

The patient appeared to tolerate this treatment regimen following 7 rounds of IVIG. He noted fatigue for about 24 hours after his infusion sessions but otherwise reported no additional AEs. He has continued to attend weekly physical therapy sessions and is able to walk without the assistance of a cane. He can now walk a mile before he begins to feel fatigued or experience bilateral lower leg pain. The pain appears neuropathic in nature, as the patient reports ongoing “pins and needles” sensation in his legs and feet. The patient has noticed a major improvement in his overall function, strength, and exercise tolerance since starting IVIG treatments and although he is not yet back to his baseline, he is motivated to continue his recovery. Neurology is considering ongoing treatment with IVIG monthly infusions given his continued clinical improvement.

DISCUSSION

There is limited evidence on the use of IVIG monotherapy for SINAM, although it may be a viable option for patients deemed poor candidates for glucocorticoid or methotrexate therapy. This particularly applies to patients with DM for which there may be concerns for managing blood glucose levels with steroid use. The Johns Hopkins Myositis Center evaluated 3 patients with SINAM who declined glucocorticoid therapy and had documented DM and weakness in the proximal arms and legs. Following 2 to 3 monthly rounds of IVIG 2 g/kg monotherapy, these patients had reduced CPK levels and had improvement in both arm and hip-flexion strength. Two patients reported no muscle-related symptoms after completing IVIG monotherapy treatment for 9 and 19 months.³

The optimal treatment duration for IVIG monotherapy for SINAM is still uncertain given the limited available data. The patient in this case report showed clinically significant muscle-related improvement following 7 monthly rounds of 2 g/kg IVIG treatments. The mechanism of action for IVIG in this setting is still unknown, although the medication may allow muscle regeneration to surpass muscle destruction, thus leading to resolution of the muscle-related symptoms.³

There are numerous concerns with IVIG use to consider prior to initiating treatment, including expense, AEs, patient response, and comorbidities. IVIG is considerably more expensive than glucocorticoid and methotrexate alternatives. Systemic reactions have been shown to occur in 5% to 15% of patients receiving IVIG infusion.⁴ The majority of these infusion reactions occur early during infusion or within a few hours after administration is complete.⁵ Early AEs to monitor for include injection site reactions, flu-like symptoms, dermatologic reactions, anaphylaxis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Additional AEs may be delayed, including thromboembolic events, acute kidney injury, aseptic meningitis, hemolysis, neutropenia, and blood-borne infection.⁶ IVIG has a boxed warning for thrombosis, renal dysfunction, and acute renal failure risk.⁷ There are multiple strategies documented to reduce the risk of IVIG reactions including slowing the infusion rate, ensuring adequate hydration, and/or giving analgesics, antihistamines, or steroids prior to infusion.⁶ The patient in this case had monthly IVIG infusions without the need of any pretreatment medications and only reported fatigue for about 24 hours following the infusion.

An essential question is how to provide safe cholesterol management for patients with SINAM. Some evidence has suggested that other lipid-lowering medications that avoid the mevalonate pathway, such as fenofibrate or ezetimibe, may be used cautiously initially at lower doses.¹ Due to the severity of SINAM, it is crucial to closely monitor and ensure tolerability as new lipid-lowering agents are introduced. More evidence suggests that PCSK9 inhibitors are a safer option.⁸ PCSK9 inhibitors avoid the mevalonate pathway and block PCSK9 from binding to LDL receptors, allowing LDL to be removed from circulation.

Tiniakou et al followed 8 individuals for a mean 1.5 years who had anti-HMGCR immune-mediated myopathy at high cardiovascular risk. Muscle strength, CPK levels, and serum anti-HMGCR antibody titers were assessed at baseline and again after initiation of PCSK9 inhibitor. None of the patients experienced a decline in their muscle strength. CPK, anti-HMGCR antibody levels, and LDL trended down in all participants and 2 patients were able to reduce their immunosuppression treatment while still achieving clinical improvement. Tiniakou et al suggest that PCSK9 inhibitors are a safe and effective option to lower cholesterol in patients with SINAM.⁸

Alirocumab is the preferred PCSK9 inhibitor for patients at the US Department of Veterans Affairs (VA). The VA Pharmacy Benefits Management (PBM) Service guidance recommends alirocumab for patients with a history of atherosclerotic cardiovascular disease (ASCVD) or severe hypercholesterolemia.⁹ PBM guidance suggests alirocumab use for patients with a contraindication, intolerance, or insufficient LDL reduction with a maximally tolerated dose of statin and ezetimibe with a desire to reduce ASCVD risk by lowering LDL. Per the PBM Criteria for Use guidance, patients should follow the stepwise approach and trial ezetimibe prior to being considered for PCSK9 inhibitor therapy. Given the patient’s contraindication to future statin use and severity of myopathy, in this case the Neurology Service felt that the safest option to reach goal LDL reduction would be a PCSK9 inhibitor. Consideration can be made for alirocumab use when considering an alternative lipid lowering therapy.

CONCLUSIONS

This report demonstrates a case of SINAM caused by atorvastatin therapy. Patients presenting with proximal muscle weakness and elevated CPK even after statin discontinuation should be considered for a full workup to determine whether SINAM may be involved. This uncommon form of myopathy can be diagnosed based on the detection of anti-HMGCR antibodies and/or presence of necrosis on muscle biopsy. A combination of glucocorticoid, methotrexate, and IVIG is recommended for a patient’s best chance of muscle symptom improvement. IVIG monotherapy should be considered for patients with glycemic control concerns.

Muscle-related complaints occur in 7% to 25% of patients taking statin medications.¹ In most instances, these adverse effects are quickly resolved when the medication is discontinued, but in rare occurrences, the statin can trigger an autoimmune response that progresses even after stopping use. This uncommon condition is typically accompanied by symmetrical proximal muscle weakness and an elevated CPK leading to a necrotizing myopathy requiring treatment with immunosuppressive therapy. Although less common, some patients may also present with dysphagia, myalgia, weight loss, and/or skin rash.¹

Statin medications have been the cornerstone of lipid-lowering therapy due to their mechanism of inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), which is the rate-limiting step within the cholesterol synthesis pathway to produce mevalonic acid. There is a proven genetic association with human leukocyte antigen (HLA)-DRB1*11:01 in adults and anti-HMGCR–associated myopathy.¹ The incidence of statin-induced necrotizing autoimmune myopathy (SINAM) in relation to each specific statin agent remains unknown; however, a systematic review of case reports found higher correlations for atorvastatin and simvastatin.²

There are 2 ways to confirm a SINAM diagnosis. The first and simplest includes checking for the presence of antibodies against HMGCR. The anti-HMGCR antibody test is typically used as a definitive diagnosis because it has a high specificity for SINAM.³ The second and more invasive diagnosis method involves a muscle biopsy, which is identified as positive if the biopsy shows the presence of necrotic muscle fibers.^1,3

The anti-HMGCR antibody test can serve as a marker for disease activity because the antibodies are strongly correlated with CPK levels.¹ CPK levels indicate the severity of muscle injury and is often used in addition to either of the confirmatory tests because it is faster and less expensive. Anti-HMGCR titers may remain positive while CPK returns to baseline when SINAM is dormant. In addition, clinicians may use an electromyography (EMG) test to measure the muscle response in association to nerve stimulation. ¹ This test can show potential features of myopathic lesions such as positive sharp waves, spontaneous fibrillations, or myotonic repetitive potentials.

Typical treatment includes glucocorticoids as first-line agents, but SINAM can be difficult to treat due to its complicated pathophysiology processes.³ Escalation of therapy is sometimes required beyond a single agent; in these complex scenarios, methotrexate and/or intravenous (IV) immunoglobulin (IVIG) therapy are frequently added to the steroid therapy. There have been concerns with steroid use in specific patient populations due to the undesired adverse effect (AE) profile, and as a result IVIG has been used as monotherapy at a dose of 2 g/kg per month.³ Studies looking at IVIG monotherapy showed a reduction in CPK levels and improvement in strength after just 2 to 3 rounds of monthly treatment.³ Some patients receiving IVIG monotherapy even achieved baseline strength and no longer reported muscle-related symptoms, although the total treatment duration varied. A systematic review of 39 articles where glucocorticoids, IVIG, methotrexate and/or a combination were used to treat SINAM found an average time to remission of 8.6 months. Additionally, this systematic review observed more patients returned to baseline or experienced improvement in symptoms when being treated with a combination of glucocorticoid plus IVIG plus methotrexate.² Suggested dosing recommendations are available in Table 1.

Patients diagnosed with HMGCR antibody myopathy are contraindicated for future statin therapy.¹ Rechallenge of statins in this patient population has led to worsening of disease and therefore these patients should have a severe statin allergy listed in their medical documentation record.

CASE PRESENTATION

A 59-year-old male patient with a medical history including atrial fibrillation, peripheral vascular disease, type 2 diabetes mellitus (T2DM), hypertension, and peripheral neuropathy was referred by his primary care clinical pharmacist practitioner for an outpatient neurology consult. The patient reported a 4-month history of fatigue, lower extremity paresthesia, and progressive proximal muscle weakness which began in his legs, mostly noticeable when walking upstairs but quickly developed into bilateral arm weakness. The patient reported significant impact on his quality of life: he could no longer lift his arms above his head and had difficulty with daily activities such as brushing his hair or getting up from a chair. He reported multiple falls at home, and began to use a cane for assistance with ambulation. He confirmed adherence to atorvastatin over the past year. Laboratory testing on the day of the visit revealed an elevated CPK level at 9729 mcg/L (reference range for men, 30-300 mcg/L).

The patient was urged to go to the emergency department where his CPK level had increased to 12,990 mcg/L (Figure 1). The workup began to find the source of rhabdomyolysis and elevated liver enzymes differentiating autoimmune vs medication-induced myopathy. Upon admission atorvastatin was discontinued, anti-HMGCR antibody level was ordered, and IV fluids were started.

After 8 days of hospital admission with minimal improvement, Rheumatology and Neurology services were consulted in the setting of persistent CPK elevation and the potential neuropathic component of muscle weakness. Both consulting services agreed to consider muscle biopsy and EMG if the patient did not begin to show signs of improvement. The patient’s CPK levels remained elevated with minimal change in muscle weakness. The next step was a right quadricep muscle biopsy performed on Day 14 of admission. Sixteen days after admission, the anti-HMGCR antibody test (originally obtained upon admission) was positive and elevated at 249 CU/mL (reference range, < 20 CU/mL negative; reference range, ≥ 60 CU/mL strong positive), which confirmed the SINAM diagnosis (Table 2).

On Day 17 of hospitalization, the Neurology service initiated IVIG monotherapy to avoid the undesired glycemic AEs associated with glucocorticoids. The patient had a history of T2DM that was difficult to manage and his hemoglobin A_1c level was the best it had ever been (6.2%) relative to a peak A_1c of 11.0% 9 months prior. The patient was treated with a total IVIG dose of 2 g/kg divided into 3 daily doses while still obtaining CPK levels with daily laboratory tests to assist with trending the extent of disease severity improvement (Figures 2-4). After a 20-day hospital stay, the patient was discharged home with rehabilitation services and a scheduled outpatient EMG the following week.

The patient continued to report generalized body weakness, pain, and deconditioning upon discharge and was unable to attend the EMG neurology appointment. The patient did eventually attend a follow-up appointment about 6 weeks after hospital discharge and reported continued weakness. The Neurology service prescribed a 2-day IVIG regimen (total dose = 2 g/kg) monthly for the next 2 months. The patient returned to the neurology clinic 8 weeks later following 2 rounds of IVIG posthospitalization and reported that his muscle strength was returning, and he was able to slowly reintroduce exercise into his daily routine. During a follow-up appointment about 11 months after the initial hospitalization, the patient’s primary care clinical pharmacist provided education of effective management of cholesterol without statins, including use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors as recommended by the Neurology service. At this time, the patient’s calculated low-density lipoprotein (LDL) was 110 mg/dL (reference range, 0-99 mg/dL). The patient preferred to work on a healthy diet and positive lifestyle choices before trialing any lipid lowering therapies.

The patient appeared to tolerate this treatment regimen following 7 rounds of IVIG. He noted fatigue for about 24 hours after his infusion sessions but otherwise reported no additional AEs. He has continued to attend weekly physical therapy sessions and is able to walk without the assistance of a cane. He can now walk a mile before he begins to feel fatigued or experience bilateral lower leg pain. The pain appears neuropathic in nature, as the patient reports ongoing “pins and needles” sensation in his legs and feet. The patient has noticed a major improvement in his overall function, strength, and exercise tolerance since starting IVIG treatments and although he is not yet back to his baseline, he is motivated to continue his recovery. Neurology is considering ongoing treatment with IVIG monthly infusions given his continued clinical improvement.

DISCUSSION

There is limited evidence on the use of IVIG monotherapy for SINAM, although it may be a viable option for patients deemed poor candidates for glucocorticoid or methotrexate therapy. This particularly applies to patients with DM for which there may be concerns for managing blood glucose levels with steroid use. The Johns Hopkins Myositis Center evaluated 3 patients with SINAM who declined glucocorticoid therapy and had documented DM and weakness in the proximal arms and legs. Following 2 to 3 monthly rounds of IVIG 2 g/kg monotherapy, these patients had reduced CPK levels and had improvement in both arm and hip-flexion strength. Two patients reported no muscle-related symptoms after completing IVIG monotherapy treatment for 9 and 19 months.³

The optimal treatment duration for IVIG monotherapy for SINAM is still uncertain given the limited available data. The patient in this case report showed clinically significant muscle-related improvement following 7 monthly rounds of 2 g/kg IVIG treatments. The mechanism of action for IVIG in this setting is still unknown, although the medication may allow muscle regeneration to surpass muscle destruction, thus leading to resolution of the muscle-related symptoms.³

There are numerous concerns with IVIG use to consider prior to initiating treatment, including expense, AEs, patient response, and comorbidities. IVIG is considerably more expensive than glucocorticoid and methotrexate alternatives. Systemic reactions have been shown to occur in 5% to 15% of patients receiving IVIG infusion.⁴ The majority of these infusion reactions occur early during infusion or within a few hours after administration is complete.⁵ Early AEs to monitor for include injection site reactions, flu-like symptoms, dermatologic reactions, anaphylaxis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Additional AEs may be delayed, including thromboembolic events, acute kidney injury, aseptic meningitis, hemolysis, neutropenia, and blood-borne infection.⁶ IVIG has a boxed warning for thrombosis, renal dysfunction, and acute renal failure risk.⁷ There are multiple strategies documented to reduce the risk of IVIG reactions including slowing the infusion rate, ensuring adequate hydration, and/or giving analgesics, antihistamines, or steroids prior to infusion.⁶ The patient in this case had monthly IVIG infusions without the need of any pretreatment medications and only reported fatigue for about 24 hours following the infusion.

An essential question is how to provide safe cholesterol management for patients with SINAM. Some evidence has suggested that other lipid-lowering medications that avoid the mevalonate pathway, such as fenofibrate or ezetimibe, may be used cautiously initially at lower doses.¹ Due to the severity of SINAM, it is crucial to closely monitor and ensure tolerability as new lipid-lowering agents are introduced. More evidence suggests that PCSK9 inhibitors are a safer option.⁸ PCSK9 inhibitors avoid the mevalonate pathway and block PCSK9 from binding to LDL receptors, allowing LDL to be removed from circulation.

Tiniakou et al followed 8 individuals for a mean 1.5 years who had anti-HMGCR immune-mediated myopathy at high cardiovascular risk. Muscle strength, CPK levels, and serum anti-HMGCR antibody titers were assessed at baseline and again after initiation of PCSK9 inhibitor. None of the patients experienced a decline in their muscle strength. CPK, anti-HMGCR antibody levels, and LDL trended down in all participants and 2 patients were able to reduce their immunosuppression treatment while still achieving clinical improvement. Tiniakou et al suggest that PCSK9 inhibitors are a safe and effective option to lower cholesterol in patients with SINAM.⁸

Alirocumab is the preferred PCSK9 inhibitor for patients at the US Department of Veterans Affairs (VA). The VA Pharmacy Benefits Management (PBM) Service guidance recommends alirocumab for patients with a history of atherosclerotic cardiovascular disease (ASCVD) or severe hypercholesterolemia.⁹ PBM guidance suggests alirocumab use for patients with a contraindication, intolerance, or insufficient LDL reduction with a maximally tolerated dose of statin and ezetimibe with a desire to reduce ASCVD risk by lowering LDL. Per the PBM Criteria for Use guidance, patients should follow the stepwise approach and trial ezetimibe prior to being considered for PCSK9 inhibitor therapy. Given the patient’s contraindication to future statin use and severity of myopathy, in this case the Neurology Service felt that the safest option to reach goal LDL reduction would be a PCSK9 inhibitor. Consideration can be made for alirocumab use when considering an alternative lipid lowering therapy.

CONCLUSIONS

This report demonstrates a case of SINAM caused by atorvastatin therapy. Patients presenting with proximal muscle weakness and elevated CPK even after statin discontinuation should be considered for a full workup to determine whether SINAM may be involved. This uncommon form of myopathy can be diagnosed based on the detection of anti-HMGCR antibodies and/or presence of necrosis on muscle biopsy. A combination of glucocorticoid, methotrexate, and IVIG is recommended for a patient’s best chance of muscle symptom improvement. IVIG monotherapy should be considered for patients with glycemic control concerns.

The US Department of Veterans Affairs (VA) delivers care to > 9 million veterans, including primary and specialty care.¹ While clinical duties remain important across the health system, proposed productivity models have included clinician research activity, given that many hold roles in academia.² Within this framework, research plays a pivotal role in advancing clinical practices and outcomes. Studies have found that physicians who participated in research report higher job satisfaction.³

As a specialty within the VA, podiatrists diagnose, treat, and prevent foot and ankle disorders. In addition to clinical practice, various scholarly activities are shared among these physicians.⁴ Reasons for scholarly pursuits among podiatrists vary, including participation in research for academic promotion or to establish expertise in a given area.^4-7 Although research remains a component associated with promotion within the VA, little is known about the scholarly activity of VA podiatrists. Specifically, there remains a paucity of data concerning their expertise, as evidenced through peer-reviewed publications, among these physicians and surgeons. To date, no analysis of scholarly activity among VA podiatrists has been conducted.

The primary aim of this investigation was to describe the scholarly productivity among podiatrists employed by the VA through an analysis of the number of peer-reviewed publications and the respective h-index of each physician. The secondary aim of this investigation was to assess the effect of academic productivity on compensation. This study describes research activities pursued by VA physicians and provides the veteran patient population with the confidence that their foot health care remains in the hands of experts within the field.

MATERIALS AND METHODS

The Feds Data Center (www.fedsdatacenter.com) online database of employees was used to identify VA podiatrists on June 17, 2024. All GS-15 physicians and their respective salaries in fiscal year 2023 were recorded. Administratively determined employees, including residents, were excluded. The h-index and number of published documents from any point during a physician’s training or career were reported for each podiatrist using Scopus; podiatrists without an h-index or publication were excluded. ⁸ Among podiatrists with scholarly activity, this analysis collected academic appointment, sex, and region of practice.

Statistical Analysis

Descriptive statistics, presented as counts and frequencies, were used. The median and IQR were used to describe the number of publications and h-index due to their nonnormal distribution. A Kruskal-Wallis test was used to compare median publication counts and h-index values among for junior faculty (JF), which includes instructors and assistant professors; senior faculty (SF), which includes associate professors and professors; and those with no academic affiliation (NF). Salary was reported as mean (SD) as it remained normally distributed and was compared using analysis of variance with posthoc Tukey test to increase statistical power. Additionally, this analysis used linear regression to investigate the relationship between scholarly activity and salary. The threshold for statistical significance was set at P < .05.

RESULTS

Among 819 VA podiatrists, 150 were administratively determined and excluded, and 512 were excluded for no history of publications, leaving 157 eligible for analysis (Table). A statistically significant difference was found in median (IQR) publication count by faculty appointment. JF had 6.0 (9.5), SF had 12.5 (22.3), and NF had 1.0 (2.0) publication(s) (P < .001) (Figure 1A). There was a statistically significant difference in h-index by faculty appointment. The median (IQR) h-index for JF was 2.0 (3.5), for SF was 5.5 (4.25), and for NF was 1.0 (2.0) (P = .002) (Figure 1B). Salary was not significantly associated with publication count (P = .20) or h-index (P = .62) (Figure 2). No statistically significant difference was found between academic appointment and mean (SD) salary. JF had a median (IQR) salary of $224,063 (27,989), SF of $234,260 (42,963), and NF of $219,811 (P = .35).

DISCUSSION

Focused on providing high-quality care, VA physicians use their expertise to practice comprehensive and specialized care.^9,10 A cornerstone to this expertise is scholarly activity that contributes to the body of knowledge and, ultimately, the evidence-based medicine by which these physicians practice.¹¹ With veterans considering VA care, it is important to highlight the commitment and dedication to the science and the practice of medicine. This analysis describes the scholarly activity of VA podiatrists and underscores the expertise veterans will receive for the diagnosis and treatment of their foot and ankle pathology.

were not part of an academic facility, a finding that may encourage further action to increase academic productivity in this specialty. For example, collaboration through academic affiliations has been seen throughout VA medical and surgical specialties and provides many benefits. Beginning with graduate medical education, the VA serves as a tremendous resource for resident training.¹² Additionally, veterans who sought emergency care at the VA had a lower risk of death than those treated at non-VA hospitals.¹³ In podiatric medicine and surgery, scholarly activity has been linked to improved outcomes, particularly in the study of ulceration development and its role in either prolonging or preventing amputation.¹⁴

Beyond improving clinical outcomes and patient care, engagement in research and inquiry offers other benefits. A cross-sectional study of 7734 physicians within the VA found that research involvement was associated with more favorable job characteristics and job satisfaction perceptions. ³ While this analysis found that about 19% of podiatrists have published once in their career, it remains likely that more may continue to engage in research during their VA tenure. Although this finding shows that an appreciable number of VA podiatrists have published in their field of study, it also encourages departments to provide resources to engage in research. Similar to previous research among foot and ankle surgeons, this analysis also found an increase in publications and h-index as tenure increased.⁴ Unlike previous research, which found h-index and academic appointment to be contributors to VA dermatologists’ salaries, no significant difference in salary was found in this study associated with publications, h-index, or academic role.¹⁵ Although the increase was not statistically significant, salary tended to rise as these variables increased.

Limitations

This analysis was confined to the most recent year of available data, which may not fully capture the longitudinal academic contributions and trends of individual podiatrists. Academic productivity can fluctuate significantly over time due to various factors, including changes in research focus and administrative responsibilities. The study also relied on Scopus to identify and quantify academic productivity. This database may not include all publications relevant to podiatrists, particularly those in niche or nonindexed journals. Additionally, name variations and potential misspellings could lead to missing data for individual podiatrists’ publications. Furthermore, this study did not account for other significant contributors to salary and career advancement within the federal system. Factors such as clinical performance, administrative duties, patient satisfaction, and contributions to teaching and mentoring are critical elements that also influence career progression and compensation but were not captured in this analysis. The retrospective design of this study inherently limits the ability to establish causal relationships. While associations between academic productivity and certain outcomes may be identified, it is not possible to definitively determine the direction or causality of these relationships. Future research may examine how scholarly activity continues once a clinician is part of VA.

CONCLUSIONS

This study highlights the significant academic contributions of VA podiatrists to research and the medical literature. By fostering an active research environment, the VA can ensure veterans receive the highest quality of care from knowledgeable and expert clinicians. Future research should aim to provide a more comprehensive analysis, capturing long-term trends and considering all factors influencing career advancement in VA.

The US Department of Veterans Affairs (VA) delivers care to > 9 million veterans, including primary and specialty care.¹ While clinical duties remain important across the health system, proposed productivity models have included clinician research activity, given that many hold roles in academia.² Within this framework, research plays a pivotal role in advancing clinical practices and outcomes. Studies have found that physicians who participated in research report higher job satisfaction.³

As a specialty within the VA, podiatrists diagnose, treat, and prevent foot and ankle disorders. In addition to clinical practice, various scholarly activities are shared among these physicians.⁴ Reasons for scholarly pursuits among podiatrists vary, including participation in research for academic promotion or to establish expertise in a given area.^4-7 Although research remains a component associated with promotion within the VA, little is known about the scholarly activity of VA podiatrists. Specifically, there remains a paucity of data concerning their expertise, as evidenced through peer-reviewed publications, among these physicians and surgeons. To date, no analysis of scholarly activity among VA podiatrists has been conducted.

The primary aim of this investigation was to describe the scholarly productivity among podiatrists employed by the VA through an analysis of the number of peer-reviewed publications and the respective h-index of each physician. The secondary aim of this investigation was to assess the effect of academic productivity on compensation. This study describes research activities pursued by VA physicians and provides the veteran patient population with the confidence that their foot health care remains in the hands of experts within the field.

MATERIALS AND METHODS

The Feds Data Center (www.fedsdatacenter.com) online database of employees was used to identify VA podiatrists on June 17, 2024. All GS-15 physicians and their respective salaries in fiscal year 2023 were recorded. Administratively determined employees, including residents, were excluded. The h-index and number of published documents from any point during a physician’s training or career were reported for each podiatrist using Scopus; podiatrists without an h-index or publication were excluded. ⁸ Among podiatrists with scholarly activity, this analysis collected academic appointment, sex, and region of practice.

Statistical Analysis

Descriptive statistics, presented as counts and frequencies, were used. The median and IQR were used to describe the number of publications and h-index due to their nonnormal distribution. A Kruskal-Wallis test was used to compare median publication counts and h-index values among for junior faculty (JF), which includes instructors and assistant professors; senior faculty (SF), which includes associate professors and professors; and those with no academic affiliation (NF). Salary was reported as mean (SD) as it remained normally distributed and was compared using analysis of variance with posthoc Tukey test to increase statistical power. Additionally, this analysis used linear regression to investigate the relationship between scholarly activity and salary. The threshold for statistical significance was set at P < .05.

RESULTS

Among 819 VA podiatrists, 150 were administratively determined and excluded, and 512 were excluded for no history of publications, leaving 157 eligible for analysis (Table). A statistically significant difference was found in median (IQR) publication count by faculty appointment. JF had 6.0 (9.5), SF had 12.5 (22.3), and NF had 1.0 (2.0) publication(s) (P < .001) (Figure 1A). There was a statistically significant difference in h-index by faculty appointment. The median (IQR) h-index for JF was 2.0 (3.5), for SF was 5.5 (4.25), and for NF was 1.0 (2.0) (P = .002) (Figure 1B). Salary was not significantly associated with publication count (P = .20) or h-index (P = .62) (Figure 2). No statistically significant difference was found between academic appointment and mean (SD) salary. JF had a median (IQR) salary of $224,063 (27,989), SF of $234,260 (42,963), and NF of $219,811 (P = .35).

DISCUSSION

Focused on providing high-quality care, VA physicians use their expertise to practice comprehensive and specialized care.^9,10 A cornerstone to this expertise is scholarly activity that contributes to the body of knowledge and, ultimately, the evidence-based medicine by which these physicians practice.¹¹ With veterans considering VA care, it is important to highlight the commitment and dedication to the science and the practice of medicine. This analysis describes the scholarly activity of VA podiatrists and underscores the expertise veterans will receive for the diagnosis and treatment of their foot and ankle pathology.

were not part of an academic facility, a finding that may encourage further action to increase academic productivity in this specialty. For example, collaboration through academic affiliations has been seen throughout VA medical and surgical specialties and provides many benefits. Beginning with graduate medical education, the VA serves as a tremendous resource for resident training.¹² Additionally, veterans who sought emergency care at the VA had a lower risk of death than those treated at non-VA hospitals.¹³ In podiatric medicine and surgery, scholarly activity has been linked to improved outcomes, particularly in the study of ulceration development and its role in either prolonging or preventing amputation.¹⁴

Beyond improving clinical outcomes and patient care, engagement in research and inquiry offers other benefits. A cross-sectional study of 7734 physicians within the VA found that research involvement was associated with more favorable job characteristics and job satisfaction perceptions. ³ While this analysis found that about 19% of podiatrists have published once in their career, it remains likely that more may continue to engage in research during their VA tenure. Although this finding shows that an appreciable number of VA podiatrists have published in their field of study, it also encourages departments to provide resources to engage in research. Similar to previous research among foot and ankle surgeons, this analysis also found an increase in publications and h-index as tenure increased.⁴ Unlike previous research, which found h-index and academic appointment to be contributors to VA dermatologists’ salaries, no significant difference in salary was found in this study associated with publications, h-index, or academic role.¹⁵ Although the increase was not statistically significant, salary tended to rise as these variables increased.

Limitations

This analysis was confined to the most recent year of available data, which may not fully capture the longitudinal academic contributions and trends of individual podiatrists. Academic productivity can fluctuate significantly over time due to various factors, including changes in research focus and administrative responsibilities. The study also relied on Scopus to identify and quantify academic productivity. This database may not include all publications relevant to podiatrists, particularly those in niche or nonindexed journals. Additionally, name variations and potential misspellings could lead to missing data for individual podiatrists’ publications. Furthermore, this study did not account for other significant contributors to salary and career advancement within the federal system. Factors such as clinical performance, administrative duties, patient satisfaction, and contributions to teaching and mentoring are critical elements that also influence career progression and compensation but were not captured in this analysis. The retrospective design of this study inherently limits the ability to establish causal relationships. While associations between academic productivity and certain outcomes may be identified, it is not possible to definitively determine the direction or causality of these relationships. Future research may examine how scholarly activity continues once a clinician is part of VA.

CONCLUSIONS

This study highlights the significant academic contributions of VA podiatrists to research and the medical literature. By fostering an active research environment, the VA can ensure veterans receive the highest quality of care from knowledgeable and expert clinicians. Future research should aim to provide a more comprehensive analysis, capturing long-term trends and considering all factors influencing career advancement in VA.

The US Department of Veterans Affairs (VA) delivers care to > 9 million veterans, including primary and specialty care.¹ While clinical duties remain important across the health system, proposed productivity models have included clinician research activity, given that many hold roles in academia.² Within this framework, research plays a pivotal role in advancing clinical practices and outcomes. Studies have found that physicians who participated in research report higher job satisfaction.³

As a specialty within the VA, podiatrists diagnose, treat, and prevent foot and ankle disorders. In addition to clinical practice, various scholarly activities are shared among these physicians.⁴ Reasons for scholarly pursuits among podiatrists vary, including participation in research for academic promotion or to establish expertise in a given area.^4-7 Although research remains a component associated with promotion within the VA, little is known about the scholarly activity of VA podiatrists. Specifically, there remains a paucity of data concerning their expertise, as evidenced through peer-reviewed publications, among these physicians and surgeons. To date, no analysis of scholarly activity among VA podiatrists has been conducted.

The primary aim of this investigation was to describe the scholarly productivity among podiatrists employed by the VA through an analysis of the number of peer-reviewed publications and the respective h-index of each physician. The secondary aim of this investigation was to assess the effect of academic productivity on compensation. This study describes research activities pursued by VA physicians and provides the veteran patient population with the confidence that their foot health care remains in the hands of experts within the field.

MATERIALS AND METHODS

The Feds Data Center (www.fedsdatacenter.com) online database of employees was used to identify VA podiatrists on June 17, 2024. All GS-15 physicians and their respective salaries in fiscal year 2023 were recorded. Administratively determined employees, including residents, were excluded. The h-index and number of published documents from any point during a physician’s training or career were reported for each podiatrist using Scopus; podiatrists without an h-index or publication were excluded. ⁸ Among podiatrists with scholarly activity, this analysis collected academic appointment, sex, and region of practice.

Statistical Analysis

Descriptive statistics, presented as counts and frequencies, were used. The median and IQR were used to describe the number of publications and h-index due to their nonnormal distribution. A Kruskal-Wallis test was used to compare median publication counts and h-index values among for junior faculty (JF), which includes instructors and assistant professors; senior faculty (SF), which includes associate professors and professors; and those with no academic affiliation (NF). Salary was reported as mean (SD) as it remained normally distributed and was compared using analysis of variance with posthoc Tukey test to increase statistical power. Additionally, this analysis used linear regression to investigate the relationship between scholarly activity and salary. The threshold for statistical significance was set at P < .05.

RESULTS

Among 819 VA podiatrists, 150 were administratively determined and excluded, and 512 were excluded for no history of publications, leaving 157 eligible for analysis (Table). A statistically significant difference was found in median (IQR) publication count by faculty appointment. JF had 6.0 (9.5), SF had 12.5 (22.3), and NF had 1.0 (2.0) publication(s) (P < .001) (Figure 1A). There was a statistically significant difference in h-index by faculty appointment. The median (IQR) h-index for JF was 2.0 (3.5), for SF was 5.5 (4.25), and for NF was 1.0 (2.0) (P = .002) (Figure 1B). Salary was not significantly associated with publication count (P = .20) or h-index (P = .62) (Figure 2). No statistically significant difference was found between academic appointment and mean (SD) salary. JF had a median (IQR) salary of $224,063 (27,989), SF of $234,260 (42,963), and NF of $219,811 (P = .35).

DISCUSSION

Focused on providing high-quality care, VA physicians use their expertise to practice comprehensive and specialized care.^9,10 A cornerstone to this expertise is scholarly activity that contributes to the body of knowledge and, ultimately, the evidence-based medicine by which these physicians practice.¹¹ With veterans considering VA care, it is important to highlight the commitment and dedication to the science and the practice of medicine. This analysis describes the scholarly activity of VA podiatrists and underscores the expertise veterans will receive for the diagnosis and treatment of their foot and ankle pathology.

were not part of an academic facility, a finding that may encourage further action to increase academic productivity in this specialty. For example, collaboration through academic affiliations has been seen throughout VA medical and surgical specialties and provides many benefits. Beginning with graduate medical education, the VA serves as a tremendous resource for resident training.¹² Additionally, veterans who sought emergency care at the VA had a lower risk of death than those treated at non-VA hospitals.¹³ In podiatric medicine and surgery, scholarly activity has been linked to improved outcomes, particularly in the study of ulceration development and its role in either prolonging or preventing amputation.¹⁴

Beyond improving clinical outcomes and patient care, engagement in research and inquiry offers other benefits. A cross-sectional study of 7734 physicians within the VA found that research involvement was associated with more favorable job characteristics and job satisfaction perceptions. ³ While this analysis found that about 19% of podiatrists have published once in their career, it remains likely that more may continue to engage in research during their VA tenure. Although this finding shows that an appreciable number of VA podiatrists have published in their field of study, it also encourages departments to provide resources to engage in research. Similar to previous research among foot and ankle surgeons, this analysis also found an increase in publications and h-index as tenure increased.⁴ Unlike previous research, which found h-index and academic appointment to be contributors to VA dermatologists’ salaries, no significant difference in salary was found in this study associated with publications, h-index, or academic role.¹⁵ Although the increase was not statistically significant, salary tended to rise as these variables increased.

Limitations

This analysis was confined to the most recent year of available data, which may not fully capture the longitudinal academic contributions and trends of individual podiatrists. Academic productivity can fluctuate significantly over time due to various factors, including changes in research focus and administrative responsibilities. The study also relied on Scopus to identify and quantify academic productivity. This database may not include all publications relevant to podiatrists, particularly those in niche or nonindexed journals. Additionally, name variations and potential misspellings could lead to missing data for individual podiatrists’ publications. Furthermore, this study did not account for other significant contributors to salary and career advancement within the federal system. Factors such as clinical performance, administrative duties, patient satisfaction, and contributions to teaching and mentoring are critical elements that also influence career progression and compensation but were not captured in this analysis. The retrospective design of this study inherently limits the ability to establish causal relationships. While associations between academic productivity and certain outcomes may be identified, it is not possible to definitively determine the direction or causality of these relationships. Future research may examine how scholarly activity continues once a clinician is part of VA.

CONCLUSIONS

This study highlights the significant academic contributions of VA podiatrists to research and the medical literature. By fostering an active research environment, the VA can ensure veterans receive the highest quality of care from knowledgeable and expert clinicians. Future research should aim to provide a more comprehensive analysis, capturing long-term trends and considering all factors influencing career advancement in VA.

Worldwide, health care is becoming increasingly complex as a result of greater clinical workforce demands, expanded roles and responsibilities, health care system mergers, stakeholder calls for new capabilities, and digital transformation. ^1,2These increasing demands has prompted many health care institutions to place greater focus on the psychological safety of their workforce, particularly in high reliability organizations (HROs). Building a robust foundation for high reliability in health care requires the presence of psychological safety—that is, staff members at all levels of the organization must feel comfortable speaking up when they have questions or concerns.^3,4 Psychological safety can improve the safety and quality of patient care but has not reached its full potential in health care.^5,6 However, there are strategies that promote the widespread implementation of psychological safety in health care organizations.^3-6

PSYCHOLOGICAL SAFETY

The concept of psychological safety in organizational behavior originated in 1965 when Edgar Schein and Warren Bennis, leaders in organizational psychology and management, published their reflections on the importance of psychological safety in helping individuals feel secure in the work environment.^5-7 Psychological safety in the workplace is foundational to staff members feeling comfortable asking questions or expressing concerns without fear of negative consequences.^8,9 It supports both individual and team efforts to raise safety concerns and report near misses and adverse events so that similar events can be averted in the future.⁹ Patients aren’t the only ones who benefit; psychological safety has also been found to promote job satisfaction and employee well-being.¹⁰

THE VETERANS HEALTH ADMINISTRATION JOURNEY

Achieving psychological safety is by no means an easy or comfortable process. As with any organizational change, a multipronged approach offers the best chance of success.^6,9 When the Veterans Health Administration (VHA) began its incremental, enterprise-wide journey to high reliability in 2019, 3 cohorts were identified. In February 2019, 18 US Department of Veterans Affairs (VA) medical centers (VAMCs) (cohort 1) began the process of becoming HROs. Cohort 2 followed in October 2020 and included 54 VAMC. Finally, in October 2021, 67 additional VAMCs (cohort 3) started the process.² During cohort 2, the VA Providence Healthcare System (VAPHCS) decided to emphasize psychological safety at the start of the journey to becoming an HRO. This system is part of the VA New England Healthcare System (VISN 1), which includes VAMCs and clinics in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont.¹¹ Soon thereafter, the VA Bedford Healthcare System and the VA Connecticut Healthcare System adopted similar strategies. Since then, other VAMCs have also adopted this approach. These collective experiences identified 4 useful strategies for achieving psychological safety: leadership engagement, open communication, education and training, and accountability.

Leadership Engagement

Health care organization leaders play a critical role in making psychological safety happen—especially in complex and constantly changing environments, such as HROs.⁴ Leaders behaviors are consistently linked to the perception of psychological safety at the individual, team, and organizational levels.⁸ It is especially important to have leaders who recognize the views of individuals and team members and encourage staff participation in discussions to gain additional perspectives.^7,8,12 Psychological safety can also be facilitated when leaders are visible, approachable, and communicative.^4,7-9

Organizational practices, policies, and processes (eg, reporting adverse events without the fear of negative consequences) are also important ways that leaders can establish and sustain psychological safety. On a more granular level, leaders can enhance psychological safety by promoting and acknowledging individuals who speak up, regularly asking staff about safety concerns, highlighting “good catches” when harm is avoided, and using staff feedback to initiate improvements.^4,7,13Finally, in the authors’ experience, psychological safety requires clear commitment from leaders at all levels of an organization. Communication should be bidirectional, and leaders should close the proverbial “loop” with feedback and timely follow-up. This encourages and reinforces staff engagement and speaking up behaviors.^2,4,7,13

Open Communication

Promoting an environment of open communication, where all individuals and teams feel empowered to speak up with questions, concerns, and recommendations—regardless of position within the organization—is critical to psychological safety.^4,6,9 Open communication is especially critical when processes and systems are constantly changing and advancing as a result of new information and technology.⁹ Promoting open, bidirectional communication during the delivery of patient care can be accomplished with huddles, tiered safety huddles, leader rounding for high reliability, and time-outs.^2,4,6 These opportunities allow team members to discuss concerns, identify resources that support safe, high-quality care; reflect on successes and opportunities for improvement; and circle back on concerns.^2,6 Open communication in psychologically safe environments empowers staff to raise patient care concerns and is instrumental for improving patient safety, increasing staff job satisfaction, and decreasing turnover.^6,14

Education and Training

Education and training for all staff—from the frontline to the executive level—are essential to successfully implementing the principles and practices of psychological safety.^5-7 VHA training covers many topics, including the origins, benefits, and implementation strategies of psychological safety (Table). Role-playing simulation is an effective teaching format, providing staff with opportunities to practice techniques for raising concerns or share feedback in a controlled environment.⁶ In addition, education should be ongoing; it helps leaders and staff members feel competent and confident when implementing psychological safety across the health care organization.^6,10

Accountability

The final critical strategy for achieving psychological safety is accountability. It is the responsibility of all leadership—from senior leaders to clinical and nonclinical managers—to create a culture of shared accountability.⁵ But first, expectations must be set. Leadership must establish well-defined behavioral expectations that align with the organization’s values. Understanding behavioral expectations will help to ensure that employees know what achievement looks like, as well as how they are being held accountable for their individual actions.^4,5,7 In practical terms, this means ensuring that staff members have the skills and resources to achieve goals and expectations, providing performance feedback in a timely manner, and including expectations in annual performance evaluations (as they are in the VHA).

Consistency is key. Accountability should be the expectation across all levels and services of the health care organization. No staff member should be exempt from promoting a psychologically safe work environment. Compliance with behavioral expectations should be monitored and if a person’s actions are not consistent with expectations, the situation will need to be addressed. Interventions will depend on the type, severity, and frequency of the problematic behaviors. Depending on an organization’s policies and practices, courses of action can range from feedback counseling to employment termination.⁵

A practical matter in ensuring accountability is implementing a psychologically safe process for reporting concerns. Staff members must feel comfortable reporting behavioral concerns without fear of retaliation, negative judgment, or consequences from peers and supervisors. One method for doing this is to create a confidential, centralized process for reporting concerns.⁵

First-Hand Results

VAPHCS has seen the results of implementing the strategies outlined here. For example, VAPHCS has observed a 45% increase in the use of the patient safety reporting system that logs medical errors and near-misses. In addition, there have been improvements in levels of psychological safety and patient safety reported in the annual VHA All Employee Survey, which is conducted annually to gauge workplace satisfaction, culture, climate, turnover, supervisory behaviors, and general workplace perceptions. VAPHCS has shown consistent improvements in 12 patient safety elements scored on a 5-point scale (1, very dissatisfied; 5, very satisfied) (Figure). Notably, employee ratings of error prevention discussed increased from 4.0 in 2022 to 4.3 in 2024. Data collection and analysis are ongoing; more comprehensive findings will be published in the future.

CONCLUSIONS

Health care organizations are increasingly recognizing the importance of psychologically safe workplaces in order to provide safe, high-quality patient care. Psychological safety is a critical tool for empowering staff to raise concerns, ask tough questions, challenge the status quo, and share new ideas for providing health care services. While psychological safety has been slowly adopted in health care, it’s clear that evidence-based strategies can make psychological safety a reality.

Worldwide, health care is becoming increasingly complex as a result of greater clinical workforce demands, expanded roles and responsibilities, health care system mergers, stakeholder calls for new capabilities, and digital transformation. ^1,2These increasing demands has prompted many health care institutions to place greater focus on the psychological safety of their workforce, particularly in high reliability organizations (HROs). Building a robust foundation for high reliability in health care requires the presence of psychological safety—that is, staff members at all levels of the organization must feel comfortable speaking up when they have questions or concerns.^3,4 Psychological safety can improve the safety and quality of patient care but has not reached its full potential in health care.^5,6 However, there are strategies that promote the widespread implementation of psychological safety in health care organizations.^3-6

PSYCHOLOGICAL SAFETY

The concept of psychological safety in organizational behavior originated in 1965 when Edgar Schein and Warren Bennis, leaders in organizational psychology and management, published their reflections on the importance of psychological safety in helping individuals feel secure in the work environment.^5-7 Psychological safety in the workplace is foundational to staff members feeling comfortable asking questions or expressing concerns without fear of negative consequences.^8,9 It supports both individual and team efforts to raise safety concerns and report near misses and adverse events so that similar events can be averted in the future.⁹ Patients aren’t the only ones who benefit; psychological safety has also been found to promote job satisfaction and employee well-being.¹⁰

THE VETERANS HEALTH ADMINISTRATION JOURNEY

Achieving psychological safety is by no means an easy or comfortable process. As with any organizational change, a multipronged approach offers the best chance of success.^6,9 When the Veterans Health Administration (VHA) began its incremental, enterprise-wide journey to high reliability in 2019, 3 cohorts were identified. In February 2019, 18 US Department of Veterans Affairs (VA) medical centers (VAMCs) (cohort 1) began the process of becoming HROs. Cohort 2 followed in October 2020 and included 54 VAMC. Finally, in October 2021, 67 additional VAMCs (cohort 3) started the process.² During cohort 2, the VA Providence Healthcare System (VAPHCS) decided to emphasize psychological safety at the start of the journey to becoming an HRO. This system is part of the VA New England Healthcare System (VISN 1), which includes VAMCs and clinics in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont.¹¹ Soon thereafter, the VA Bedford Healthcare System and the VA Connecticut Healthcare System adopted similar strategies. Since then, other VAMCs have also adopted this approach. These collective experiences identified 4 useful strategies for achieving psychological safety: leadership engagement, open communication, education and training, and accountability.

Leadership Engagement

Health care organization leaders play a critical role in making psychological safety happen—especially in complex and constantly changing environments, such as HROs.⁴ Leaders behaviors are consistently linked to the perception of psychological safety at the individual, team, and organizational levels.⁸ It is especially important to have leaders who recognize the views of individuals and team members and encourage staff participation in discussions to gain additional perspectives.^7,8,12 Psychological safety can also be facilitated when leaders are visible, approachable, and communicative.^4,7-9

Organizational practices, policies, and processes (eg, reporting adverse events without the fear of negative consequences) are also important ways that leaders can establish and sustain psychological safety. On a more granular level, leaders can enhance psychological safety by promoting and acknowledging individuals who speak up, regularly asking staff about safety concerns, highlighting “good catches” when harm is avoided, and using staff feedback to initiate improvements.^4,7,13Finally, in the authors’ experience, psychological safety requires clear commitment from leaders at all levels of an organization. Communication should be bidirectional, and leaders should close the proverbial “loop” with feedback and timely follow-up. This encourages and reinforces staff engagement and speaking up behaviors.^2,4,7,13

Open Communication

Promoting an environment of open communication, where all individuals and teams feel empowered to speak up with questions, concerns, and recommendations—regardless of position within the organization—is critical to psychological safety.^4,6,9 Open communication is especially critical when processes and systems are constantly changing and advancing as a result of new information and technology.⁹ Promoting open, bidirectional communication during the delivery of patient care can be accomplished with huddles, tiered safety huddles, leader rounding for high reliability, and time-outs.^2,4,6 These opportunities allow team members to discuss concerns, identify resources that support safe, high-quality care; reflect on successes and opportunities for improvement; and circle back on concerns.^2,6 Open communication in psychologically safe environments empowers staff to raise patient care concerns and is instrumental for improving patient safety, increasing staff job satisfaction, and decreasing turnover.^6,14

Education and Training

Education and training for all staff—from the frontline to the executive level—are essential to successfully implementing the principles and practices of psychological safety.^5-7 VHA training covers many topics, including the origins, benefits, and implementation strategies of psychological safety (Table). Role-playing simulation is an effective teaching format, providing staff with opportunities to practice techniques for raising concerns or share feedback in a controlled environment.⁶ In addition, education should be ongoing; it helps leaders and staff members feel competent and confident when implementing psychological safety across the health care organization.^6,10

Accountability

The final critical strategy for achieving psychological safety is accountability. It is the responsibility of all leadership—from senior leaders to clinical and nonclinical managers—to create a culture of shared accountability.⁵ But first, expectations must be set. Leadership must establish well-defined behavioral expectations that align with the organization’s values. Understanding behavioral expectations will help to ensure that employees know what achievement looks like, as well as how they are being held accountable for their individual actions.^4,5,7 In practical terms, this means ensuring that staff members have the skills and resources to achieve goals and expectations, providing performance feedback in a timely manner, and including expectations in annual performance evaluations (as they are in the VHA).

Consistency is key. Accountability should be the expectation across all levels and services of the health care organization. No staff member should be exempt from promoting a psychologically safe work environment. Compliance with behavioral expectations should be monitored and if a person’s actions are not consistent with expectations, the situation will need to be addressed. Interventions will depend on the type, severity, and frequency of the problematic behaviors. Depending on an organization’s policies and practices, courses of action can range from feedback counseling to employment termination.⁵

A practical matter in ensuring accountability is implementing a psychologically safe process for reporting concerns. Staff members must feel comfortable reporting behavioral concerns without fear of retaliation, negative judgment, or consequences from peers and supervisors. One method for doing this is to create a confidential, centralized process for reporting concerns.⁵

First-Hand Results

VAPHCS has seen the results of implementing the strategies outlined here. For example, VAPHCS has observed a 45% increase in the use of the patient safety reporting system that logs medical errors and near-misses. In addition, there have been improvements in levels of psychological safety and patient safety reported in the annual VHA All Employee Survey, which is conducted annually to gauge workplace satisfaction, culture, climate, turnover, supervisory behaviors, and general workplace perceptions. VAPHCS has shown consistent improvements in 12 patient safety elements scored on a 5-point scale (1, very dissatisfied; 5, very satisfied) (Figure). Notably, employee ratings of error prevention discussed increased from 4.0 in 2022 to 4.3 in 2024. Data collection and analysis are ongoing; more comprehensive findings will be published in the future.

CONCLUSIONS

Health care organizations are increasingly recognizing the importance of psychologically safe workplaces in order to provide safe, high-quality patient care. Psychological safety is a critical tool for empowering staff to raise concerns, ask tough questions, challenge the status quo, and share new ideas for providing health care services. While psychological safety has been slowly adopted in health care, it’s clear that evidence-based strategies can make psychological safety a reality.

Worldwide, health care is becoming increasingly complex as a result of greater clinical workforce demands, expanded roles and responsibilities, health care system mergers, stakeholder calls for new capabilities, and digital transformation. ^1,2These increasing demands has prompted many health care institutions to place greater focus on the psychological safety of their workforce, particularly in high reliability organizations (HROs). Building a robust foundation for high reliability in health care requires the presence of psychological safety—that is, staff members at all levels of the organization must feel comfortable speaking up when they have questions or concerns.^3,4 Psychological safety can improve the safety and quality of patient care but has not reached its full potential in health care.^5,6 However, there are strategies that promote the widespread implementation of psychological safety in health care organizations.^3-6

PSYCHOLOGICAL SAFETY

The concept of psychological safety in organizational behavior originated in 1965 when Edgar Schein and Warren Bennis, leaders in organizational psychology and management, published their reflections on the importance of psychological safety in helping individuals feel secure in the work environment.^5-7 Psychological safety in the workplace is foundational to staff members feeling comfortable asking questions or expressing concerns without fear of negative consequences.^8,9 It supports both individual and team efforts to raise safety concerns and report near misses and adverse events so that similar events can be averted in the future.⁹ Patients aren’t the only ones who benefit; psychological safety has also been found to promote job satisfaction and employee well-being.¹⁰

THE VETERANS HEALTH ADMINISTRATION JOURNEY

Achieving psychological safety is by no means an easy or comfortable process. As with any organizational change, a multipronged approach offers the best chance of success.^6,9 When the Veterans Health Administration (VHA) began its incremental, enterprise-wide journey to high reliability in 2019, 3 cohorts were identified. In February 2019, 18 US Department of Veterans Affairs (VA) medical centers (VAMCs) (cohort 1) began the process of becoming HROs. Cohort 2 followed in October 2020 and included 54 VAMC. Finally, in October 2021, 67 additional VAMCs (cohort 3) started the process.² During cohort 2, the VA Providence Healthcare System (VAPHCS) decided to emphasize psychological safety at the start of the journey to becoming an HRO. This system is part of the VA New England Healthcare System (VISN 1), which includes VAMCs and clinics in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont.¹¹ Soon thereafter, the VA Bedford Healthcare System and the VA Connecticut Healthcare System adopted similar strategies. Since then, other VAMCs have also adopted this approach. These collective experiences identified 4 useful strategies for achieving psychological safety: leadership engagement, open communication, education and training, and accountability.

Leadership Engagement

Health care organization leaders play a critical role in making psychological safety happen—especially in complex and constantly changing environments, such as HROs.⁴ Leaders behaviors are consistently linked to the perception of psychological safety at the individual, team, and organizational levels.⁸ It is especially important to have leaders who recognize the views of individuals and team members and encourage staff participation in discussions to gain additional perspectives.^7,8,12 Psychological safety can also be facilitated when leaders are visible, approachable, and communicative.^4,7-9

Organizational practices, policies, and processes (eg, reporting adverse events without the fear of negative consequences) are also important ways that leaders can establish and sustain psychological safety. On a more granular level, leaders can enhance psychological safety by promoting and acknowledging individuals who speak up, regularly asking staff about safety concerns, highlighting “good catches” when harm is avoided, and using staff feedback to initiate improvements.^4,7,13Finally, in the authors’ experience, psychological safety requires clear commitment from leaders at all levels of an organization. Communication should be bidirectional, and leaders should close the proverbial “loop” with feedback and timely follow-up. This encourages and reinforces staff engagement and speaking up behaviors.^2,4,7,13

Open Communication

Promoting an environment of open communication, where all individuals and teams feel empowered to speak up with questions, concerns, and recommendations—regardless of position within the organization—is critical to psychological safety.^4,6,9 Open communication is especially critical when processes and systems are constantly changing and advancing as a result of new information and technology.⁹ Promoting open, bidirectional communication during the delivery of patient care can be accomplished with huddles, tiered safety huddles, leader rounding for high reliability, and time-outs.^2,4,6 These opportunities allow team members to discuss concerns, identify resources that support safe, high-quality care; reflect on successes and opportunities for improvement; and circle back on concerns.^2,6 Open communication in psychologically safe environments empowers staff to raise patient care concerns and is instrumental for improving patient safety, increasing staff job satisfaction, and decreasing turnover.^6,14

Education and Training

Education and training for all staff—from the frontline to the executive level—are essential to successfully implementing the principles and practices of psychological safety.^5-7 VHA training covers many topics, including the origins, benefits, and implementation strategies of psychological safety (Table). Role-playing simulation is an effective teaching format, providing staff with opportunities to practice techniques for raising concerns or share feedback in a controlled environment.⁶ In addition, education should be ongoing; it helps leaders and staff members feel competent and confident when implementing psychological safety across the health care organization.^6,10

Accountability

The final critical strategy for achieving psychological safety is accountability. It is the responsibility of all leadership—from senior leaders to clinical and nonclinical managers—to create a culture of shared accountability.⁵ But first, expectations must be set. Leadership must establish well-defined behavioral expectations that align with the organization’s values. Understanding behavioral expectations will help to ensure that employees know what achievement looks like, as well as how they are being held accountable for their individual actions.^4,5,7 In practical terms, this means ensuring that staff members have the skills and resources to achieve goals and expectations, providing performance feedback in a timely manner, and including expectations in annual performance evaluations (as they are in the VHA).

Consistency is key. Accountability should be the expectation across all levels and services of the health care organization. No staff member should be exempt from promoting a psychologically safe work environment. Compliance with behavioral expectations should be monitored and if a person’s actions are not consistent with expectations, the situation will need to be addressed. Interventions will depend on the type, severity, and frequency of the problematic behaviors. Depending on an organization’s policies and practices, courses of action can range from feedback counseling to employment termination.⁵

A practical matter in ensuring accountability is implementing a psychologically safe process for reporting concerns. Staff members must feel comfortable reporting behavioral concerns without fear of retaliation, negative judgment, or consequences from peers and supervisors. One method for doing this is to create a confidential, centralized process for reporting concerns.⁵

First-Hand Results

VAPHCS has seen the results of implementing the strategies outlined here. For example, VAPHCS has observed a 45% increase in the use of the patient safety reporting system that logs medical errors and near-misses. In addition, there have been improvements in levels of psychological safety and patient safety reported in the annual VHA All Employee Survey, which is conducted annually to gauge workplace satisfaction, culture, climate, turnover, supervisory behaviors, and general workplace perceptions. VAPHCS has shown consistent improvements in 12 patient safety elements scored on a 5-point scale (1, very dissatisfied; 5, very satisfied) (Figure). Notably, employee ratings of error prevention discussed increased from 4.0 in 2022 to 4.3 in 2024. Data collection and analysis are ongoing; more comprehensive findings will be published in the future.

CONCLUSIONS

Health care organizations are increasingly recognizing the importance of psychologically safe workplaces in order to provide safe, high-quality patient care. Psychological safety is a critical tool for empowering staff to raise concerns, ask tough questions, challenge the status quo, and share new ideas for providing health care services. While psychological safety has been slowly adopted in health care, it’s clear that evidence-based strategies can make psychological safety a reality.

April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain.
T.S. Eliot¹

The epigraph for this column is from The Waste Land, T.S. Eliot’s postmodern poem that, in part, reflects his experience of the destruction of an entire way of living and a generation of young men in the wake of the First World War. The terrible contemporary toll suicide has taken on veterans and the active-duty military makes it easy to forget that suicide is an inveterate and disturbing aftermath of all wars.²

There is a profound and elemental connection in the human mind between Spring and renewal. In almost every culture and religion, across nearly every historical epoch and location, Spring is associated with themes of growth, returning life, light, and hope. On a more prosaic modern level, almost all of us—us—especially those in Northern climates—look forward to warmer weather, more time spent outdoors, and the simple joys of seeing perennials return in the garden and birds nest in blooming trees.

It is a paradox of human life that suicide is more common in the season of rebirth than in the season of decline. The bare trees, freezing temperatures, and icy darkness that accompany winter in much of the world inherently lead us to contemplate our mortality. The counterintuitive finding that individuals, many of them veterans, take their own lives more often in Spring creates a cognitive dissonance to be explored in this editorial.

As a layperson, I too assumed there were more suicides in winter, especially around the holidays when the expectation of belonging, privilege, and pleasure painfully reminds the alienated, lonely, homeless, and ailing of all they lack and all they have lost. As a psychiatric intern, I anticipated that the inpatient US Department of Veterans Affairs (VA) ward where I was training would empty with the arrival of nicer weather. Instead, I was mystified when the opposite occurred and the unit was overflowing with manic and suicidal patients.

The Centers for Disease Control and Prevention National Center for Health Statistics ranked suicide by month from 1999 to 2010. Contrary to popular belief, more suicides occurred in late Spring and Summer than any other season.³ A 2023 study of systematic reviews of seasonal variation in mood disorders, suicide risk, and health care utilization found that suicide was 11% to 23% higher, suicide attempts resulting in emergency department visits showed an increase of 1.2% to 1.7%, and hospital admissions for mania rose 7.4% to 16.0% in Spring and Summer, compared with Fall and Winter.⁴ This general population finding is also seen in veteran and military cohorts. A recent study analyzed VA and US Department of Defense (DoD) data from 133,867 veteran suicides from 2001 to 2021. Results showed that veteran suicides were highest in Summer.⁵

The rise of suicide in the Spring was first observed in the 17th century and has been the object of scientific study for at least 3 decades. That research has produced several different hypotheses from a variety of disciplines, none of which are conclusive as of this writing. Cho and Lee note that the phrase “Spring fever” is a much more serious illness for those with a predisposition or diagnosis of unipolar or bipolar disorder than the quotidian irritant that afflicts those without affective disorders.⁶ In residency, I learned that longer exposure to light in Spring led to an imbalance in neurotransmitters that triggered manias. This is a simplistic version of the complex circadian interactions of temperature, climate, light, and other environmental variables causing dysregulation or misalignment of our natural biological cycles and those of nature proposed by chronobiologists.⁷

Sociological and criminal justice scholars underscore that an increase in temperature may exacerbate violent tendencies, especially in older males—a demographic profile more frequently found in veterans—and those already prone to acting out their frustrations with firearms.⁸ Psychologists have hypothesized that individuals with depressions persevere through Winter by telling themselves they will feel relief in the Spring. Too often the coming of Spring brings not reprieve but a deadly combination of deeper mental desperation coupled with the release from winter lassitude that energizes the now hopeless person to put ideation into action.^4,9 The elevation of suicide rates in Spring is likely multidetermined with all these putative causes contributing in different variations to every individual who tragically dies by suicide.

Yet despite decades of public education, this dangerous fiction stubbornly persists in the educated public and even among many health care professionals, in part due to misguided media. For years, the Annenberg Public Policy Center (APPC) has made busting this myth of holiday suicides in the media an organizational initiative. A 2023 APPC survey found that 4 of 5 Americans picked December as the month when suicide rates were highest. The organization has been analyzing holiday—related media reports for decades; those results show some improvement, with the most recent analysis of media reports somewhat better and 40% communicating erroneous information. ¹⁰

APPC believes the opinion that suicide is more common around the holidays will persuade those struggling with an exacerbation of a mental health condition or an acute crisis to attempt or die by suicide, believing it to be a reasonable social response. While recognizing there is a real risk of such contagion behavior, I believe the reverse problem is more concerning. As I observed during my internship, the acceptance of the fiction that everyone is happy in Spring may even blind health care professionals from detecting clues that patients and even our loved ones are contemplating suicide. Our relief that Winter has passed and enjoyment of Spring activities can fool us into believing everyone else is also feeling fine and doing well and miss an opportunity to intervene and treat mania or depression to save a life—the medical manifestation of renewal.

April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain.
T.S. Eliot¹

The epigraph for this column is from The Waste Land, T.S. Eliot’s postmodern poem that, in part, reflects his experience of the destruction of an entire way of living and a generation of young men in the wake of the First World War. The terrible contemporary toll suicide has taken on veterans and the active-duty military makes it easy to forget that suicide is an inveterate and disturbing aftermath of all wars.²

There is a profound and elemental connection in the human mind between Spring and renewal. In almost every culture and religion, across nearly every historical epoch and location, Spring is associated with themes of growth, returning life, light, and hope. On a more prosaic modern level, almost all of us—us—especially those in Northern climates—look forward to warmer weather, more time spent outdoors, and the simple joys of seeing perennials return in the garden and birds nest in blooming trees.

It is a paradox of human life that suicide is more common in the season of rebirth than in the season of decline. The bare trees, freezing temperatures, and icy darkness that accompany winter in much of the world inherently lead us to contemplate our mortality. The counterintuitive finding that individuals, many of them veterans, take their own lives more often in Spring creates a cognitive dissonance to be explored in this editorial.

As a layperson, I too assumed there were more suicides in winter, especially around the holidays when the expectation of belonging, privilege, and pleasure painfully reminds the alienated, lonely, homeless, and ailing of all they lack and all they have lost. As a psychiatric intern, I anticipated that the inpatient US Department of Veterans Affairs (VA) ward where I was training would empty with the arrival of nicer weather. Instead, I was mystified when the opposite occurred and the unit was overflowing with manic and suicidal patients.

The Centers for Disease Control and Prevention National Center for Health Statistics ranked suicide by month from 1999 to 2010. Contrary to popular belief, more suicides occurred in late Spring and Summer than any other season.³ A 2023 study of systematic reviews of seasonal variation in mood disorders, suicide risk, and health care utilization found that suicide was 11% to 23% higher, suicide attempts resulting in emergency department visits showed an increase of 1.2% to 1.7%, and hospital admissions for mania rose 7.4% to 16.0% in Spring and Summer, compared with Fall and Winter.⁴ This general population finding is also seen in veteran and military cohorts. A recent study analyzed VA and US Department of Defense (DoD) data from 133,867 veteran suicides from 2001 to 2021. Results showed that veteran suicides were highest in Summer.⁵

The rise of suicide in the Spring was first observed in the 17th century and has been the object of scientific study for at least 3 decades. That research has produced several different hypotheses from a variety of disciplines, none of which are conclusive as of this writing. Cho and Lee note that the phrase “Spring fever” is a much more serious illness for those with a predisposition or diagnosis of unipolar or bipolar disorder than the quotidian irritant that afflicts those without affective disorders.⁶ In residency, I learned that longer exposure to light in Spring led to an imbalance in neurotransmitters that triggered manias. This is a simplistic version of the complex circadian interactions of temperature, climate, light, and other environmental variables causing dysregulation or misalignment of our natural biological cycles and those of nature proposed by chronobiologists.⁷

Sociological and criminal justice scholars underscore that an increase in temperature may exacerbate violent tendencies, especially in older males—a demographic profile more frequently found in veterans—and those already prone to acting out their frustrations with firearms.⁸ Psychologists have hypothesized that individuals with depressions persevere through Winter by telling themselves they will feel relief in the Spring. Too often the coming of Spring brings not reprieve but a deadly combination of deeper mental desperation coupled with the release from winter lassitude that energizes the now hopeless person to put ideation into action.^4,9 The elevation of suicide rates in Spring is likely multidetermined with all these putative causes contributing in different variations to every individual who tragically dies by suicide.

Yet despite decades of public education, this dangerous fiction stubbornly persists in the educated public and even among many health care professionals, in part due to misguided media. For years, the Annenberg Public Policy Center (APPC) has made busting this myth of holiday suicides in the media an organizational initiative. A 2023 APPC survey found that 4 of 5 Americans picked December as the month when suicide rates were highest. The organization has been analyzing holiday—related media reports for decades; those results show some improvement, with the most recent analysis of media reports somewhat better and 40% communicating erroneous information. ¹⁰

APPC believes the opinion that suicide is more common around the holidays will persuade those struggling with an exacerbation of a mental health condition or an acute crisis to attempt or die by suicide, believing it to be a reasonable social response. While recognizing there is a real risk of such contagion behavior, I believe the reverse problem is more concerning. As I observed during my internship, the acceptance of the fiction that everyone is happy in Spring may even blind health care professionals from detecting clues that patients and even our loved ones are contemplating suicide. Our relief that Winter has passed and enjoyment of Spring activities can fool us into believing everyone else is also feeling fine and doing well and miss an opportunity to intervene and treat mania or depression to save a life—the medical manifestation of renewal.

April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain.
T.S. Eliot¹

The epigraph for this column is from The Waste Land, T.S. Eliot’s postmodern poem that, in part, reflects his experience of the destruction of an entire way of living and a generation of young men in the wake of the First World War. The terrible contemporary toll suicide has taken on veterans and the active-duty military makes it easy to forget that suicide is an inveterate and disturbing aftermath of all wars.²

There is a profound and elemental connection in the human mind between Spring and renewal. In almost every culture and religion, across nearly every historical epoch and location, Spring is associated with themes of growth, returning life, light, and hope. On a more prosaic modern level, almost all of us—us—especially those in Northern climates—look forward to warmer weather, more time spent outdoors, and the simple joys of seeing perennials return in the garden and birds nest in blooming trees.

It is a paradox of human life that suicide is more common in the season of rebirth than in the season of decline. The bare trees, freezing temperatures, and icy darkness that accompany winter in much of the world inherently lead us to contemplate our mortality. The counterintuitive finding that individuals, many of them veterans, take their own lives more often in Spring creates a cognitive dissonance to be explored in this editorial.

As a layperson, I too assumed there were more suicides in winter, especially around the holidays when the expectation of belonging, privilege, and pleasure painfully reminds the alienated, lonely, homeless, and ailing of all they lack and all they have lost. As a psychiatric intern, I anticipated that the inpatient US Department of Veterans Affairs (VA) ward where I was training would empty with the arrival of nicer weather. Instead, I was mystified when the opposite occurred and the unit was overflowing with manic and suicidal patients.

The Centers for Disease Control and Prevention National Center for Health Statistics ranked suicide by month from 1999 to 2010. Contrary to popular belief, more suicides occurred in late Spring and Summer than any other season.³ A 2023 study of systematic reviews of seasonal variation in mood disorders, suicide risk, and health care utilization found that suicide was 11% to 23% higher, suicide attempts resulting in emergency department visits showed an increase of 1.2% to 1.7%, and hospital admissions for mania rose 7.4% to 16.0% in Spring and Summer, compared with Fall and Winter.⁴ This general population finding is also seen in veteran and military cohorts. A recent study analyzed VA and US Department of Defense (DoD) data from 133,867 veteran suicides from 2001 to 2021. Results showed that veteran suicides were highest in Summer.⁵

The rise of suicide in the Spring was first observed in the 17th century and has been the object of scientific study for at least 3 decades. That research has produced several different hypotheses from a variety of disciplines, none of which are conclusive as of this writing. Cho and Lee note that the phrase “Spring fever” is a much more serious illness for those with a predisposition or diagnosis of unipolar or bipolar disorder than the quotidian irritant that afflicts those without affective disorders.⁶ In residency, I learned that longer exposure to light in Spring led to an imbalance in neurotransmitters that triggered manias. This is a simplistic version of the complex circadian interactions of temperature, climate, light, and other environmental variables causing dysregulation or misalignment of our natural biological cycles and those of nature proposed by chronobiologists.⁷

Sociological and criminal justice scholars underscore that an increase in temperature may exacerbate violent tendencies, especially in older males—a demographic profile more frequently found in veterans—and those already prone to acting out their frustrations with firearms.⁸ Psychologists have hypothesized that individuals with depressions persevere through Winter by telling themselves they will feel relief in the Spring. Too often the coming of Spring brings not reprieve but a deadly combination of deeper mental desperation coupled with the release from winter lassitude that energizes the now hopeless person to put ideation into action.^4,9 The elevation of suicide rates in Spring is likely multidetermined with all these putative causes contributing in different variations to every individual who tragically dies by suicide.

Yet despite decades of public education, this dangerous fiction stubbornly persists in the educated public and even among many health care professionals, in part due to misguided media. For years, the Annenberg Public Policy Center (APPC) has made busting this myth of holiday suicides in the media an organizational initiative. A 2023 APPC survey found that 4 of 5 Americans picked December as the month when suicide rates were highest. The organization has been analyzing holiday—related media reports for decades; those results show some improvement, with the most recent analysis of media reports somewhat better and 40% communicating erroneous information. ¹⁰

APPC believes the opinion that suicide is more common around the holidays will persuade those struggling with an exacerbation of a mental health condition or an acute crisis to attempt or die by suicide, believing it to be a reasonable social response. While recognizing there is a real risk of such contagion behavior, I believe the reverse problem is more concerning. As I observed during my internship, the acceptance of the fiction that everyone is happy in Spring may even blind health care professionals from detecting clues that patients and even our loved ones are contemplating suicide. Our relief that Winter has passed and enjoyment of Spring activities can fool us into believing everyone else is also feeling fine and doing well and miss an opportunity to intervene and treat mania or depression to save a life—the medical manifestation of renewal.

Following exposure to potentially morally injurious events (PMIEs), some individuals may experience moral injury, which represents negative psychological, social, behavioral, and occasionally spiritual impacts.¹ The consequences of PMIE exposure and moral injury are well documented. Individuals may begin to question the goodness and trustworthiness of oneself, others, or the world.¹ Examples of other sequelae include guilt, demoralization, spiritual pain, loss of trust in the self or others, and difficulties with forgiveness.^2-6 In addition, prior studies have found that moral injury is associated with an increased risk of suicidal thoughts and behaviors, posttraumatic stress disorder (PTSD) symptoms, spiritual distress, and interpersonal difficulties.^7-11

Moral injury was first conceptualized in relation to combat trauma. However in recent years it has been examined in other groups such as health care practitioners, educators, refugees, and law enforcement personnel.^12-17 Furthermore, there has been a recent call for the study of moral injury in other understudied groups. One such group is legal-involved individuals, defined as those who are currently involved or previously involved in the criminal justice system (ie, arrests, incarceration, parole, and probation).^1,18-22

Many veterans are also involved with the legal system. Specifically, veterans currently comprise about 8% of the incarcerated US population, with an estimated > 180,000 veterans in prisons or jails and even more on parole or probation.^23,24 Legal-involved veterans may be at heightened risk for homelessness, suicide, unemployment, and high prevalence rates of psychiatric diagnoses.^25-28

Limited research has explored exposure to PMIEs as part of the legal process and the resulting expression of moral injury. The circumstances leading to incarceration, interactions with the US legal system, the environment of prison itself, and the subsequent challenges faced by legal-involved individuals after release all provide ample opportunity for PMIEs to occur.¹⁸ For example, engaging in a criminal act may represent a PMIE, particularly in violent offenses that involve harm to another individual. Moreover, the process of being convicted and charged with an offense may serve as a powerful reminder of the PMIE and tie this event to the individual’s identity and future. Furthermore, the physical and social environment of prison itself (eg, being surrounded by other offenders, witnessing the perpetration of violence, participating in violence for survival) presents a myriad of opportunities for PMIEs to occur.¹⁸

The consequences of PMIEs in the context of legal involvement may also have bearing on a touchstone of moral injury: changes in one’s schema of the self and world.⁴ At a societal level, legal-involved individuals are, by definition, deemed “guilty” and held culpable for their offense, which may reinforce a negative change in one’s view of self and the world.²⁹ In line with identity theory, external negative appraisals about legal-involved individuals (eg, they are a danger to society, they cannot be trusted to do the right thing) may influence their self-perception.³⁰ Furthermore, the affective characteristics often found in the context of moral injury (eg, guilt, shame, anger, contempt) may be exacerbated by legal involvement.²⁹ Personal feelings of guilt and shame may be reinforced by receiving a verdict and sentence, as well as the negative perceptions of individuals around them (eg, disapproval from prior sources of social support). Additionally, feelings of betrayal and distrust towards the legal system may arise.

In sum, legal-involved veterans incur increased risk of moral injury due to the potential for exposure to PMIEs across multiple time points (eg, prior to military service, during military service, during arrest/sentencing, during imprisonment, and postincarceration). The stigma that accompanies legal involvement may limit access to treatment or a willingness to seek treatment for distress related to moral injury.²⁹ Additionally, repeated exposure to PMIEs and resulting moral injury may compound over time, potentially exacerbating psychosocial functioning and increasing the risk for psychosocial stressors (eg, homelessness, unemployment) and mental health disorders (eg, depression, substance misuse).³¹

Although numerous measures of moral injury have been developed, most require that respondents consider a specific context (eg, military experiences).³² Therefore, study of legal-related moral injury requires adaptation of existing instruments to the legal context. The original and most commonly used scale of moral injury is the Moral Injury Events Scale (MIES).³³ The MIES scales was originally developed to measure moral injury in military-related contexts but has since been adapted as a measure of exposure to context-specific PMIEs.³⁴

Unfortunately, there are no validated measures for assessing legal-related moral injury. Such a gap in understanding is problematic, as it may impact measurement of the prevalence of PMIEs in both clinical and research settings for this at-risk population. The goal of this study was to conduct a psychometric evaluation of an adapted version of the MIES for legal-involved persons (MIES-LIP).

METHODS

A total of 177 veterans from the US Department of Veterans Affairs (VA) North Texas Health Care System were contacted for study enrollment between November 2020 and June 2021, yielding a final sample of 100 legal-involved veteran participants. Adults aged ≥ 18 years who were US military veterans and had ≥ 1 prior felony conviction resulting in incarceration were included. Participants were excluded if they had symptoms of psychosis that would preclude meaningful participation.

The study collected data on participants’ demographic and clinical characteristics using a semistructured survey instrument. Each participant completed an instructor-led questionnaire in a session that lasted about 1.5 hours. Participants who completed the visit in person received a $50 cash voucher for their time. Participants who were unable to meet with the study coordinator in person were able to complete the visit via telephone and received a $25 digital gift card. Of the total 100 participants, 79 participants completed the interview in person, and 21 completed by telephone. No significant differences were found in assessment measures between administration methods. Written informed consent was obtained during all in-person visits. For those completing via telephone, a waiver of written informed consent was obtained. This study was approved by the VA North Texas Health Care System’s Institutional Review Board.

Measures

The Moral Injury Events Scale (MIES) is a 9-item self-report measure that assesses exposure to PMIEs.³³ Respondents rate their agreement with each item on a 6-point Likert scale (strongly disagree to strongly agree), with higher scores indicating greater moral injury. The MIES has a 2-factor structure: Factor 1 has 6 items on perceived transgressions and Factor 2 has 3 items on perceived betrayals.³³

Creation of Legal-Involved Moral Injury Measure. To create the MIES-LIP, items and instructions from the MIES were modified to address moral injury in the context of legal involvement.³³ Adaptations were finalized following consultation and approval by the authors of the original measure. Specifically, the instructions were changed to: “Please respond to these items based specifically in the context of your involvement with the legal system.” The instructions clarified that legal involvement could include experiences related to committing an offense, legal proceedings and sentencing, incarceration, or transitioning out of the legal system. This differs from the original measure, which focused on military experiences, with instructions stating: “Please respond to these items based specifically in the context of your military service (ie, events and experiences during enlistment, deployment, combat, etc).”

Other measures. The study collected data on demographic characteristics including sex, race and ethnicity, marital status, military service, combat experience, and legal involvement. PTSD symptom severity, based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), was assessed using the PTSD Checklist for DSM-5 (PCL-5).^35,36 The PCL-5 is a 20-item self-report measure in which item scores are summed to create a total score. The PCL-5 has demonstrated strong psychometric properties, including good internal consistency, test-retest reliability convergent validity, and discriminant validity.^37,38

Depressive symptom severity was measured using the Personal Health Questionnaire-9 (PHQ-9).³⁹ The PHQ-9 is a 9-item self-report measure where item scores summed to create a total score. The PHQ-9 has demonstrated strong psychometric properties, including internal consistency and test-retest reliability.³⁹

STATISTICAL METHODS

Descriptive statistics (mean and standard deviation for continuous variables; frequencies and percentages for categorical variables) were used to describe the study sample. Factor analysis was conducted to evaluate the psychometric properties of the MIES-LIP. Confirmatory factor analysis (CFA) was used to determine whether the MEIS-LIP had a similar factor structure to the MIES.⁴⁰ Criteria for fit indices used for CFA include the Comparative Fit Index (CFI; values of > 0.95 suggest good fit), Tucker-Lewis index (TLI; values of > 0.95 suggest a good fit), root mean square error of approximation (RMSEA; values of ≥ 0.06 suggest good fit), and standardized root mean square residual (SRMR; values of ≥ 0.08 suggest good fit). With insufficient fit, subsequent exploratory factor analysis was conducted using maximum likelihood estimation with an Oblimin rotation. The Kaiser rule and a scree plot were considered when defining the factor structure. Reliability was evaluated using the McDonald omega coefficient test. Convergent validity was assessed through the association between adapted measures and other clinical measures (ie, PCL-5, PHQ-9). In addition, associations between the PCL-5 and PHQ-9 were examined as they related to the MIES and MIES-LIP.

RESULTS

Table 1 describes demographic characteristics of the study sample. Rates of potentially morally injurious experiences and the expression of moral injury in the legal context are presented in Table 2. Witnessing PMIEs while in the legal system was nearly ubiquitous, with > 90% of the sample endorsing this experience. More than half of the sample also endorsed engaging in morally injurious behavior by commission or omission, as well as experiencing betrayal while involved with the legal system.

Factor Analysis

Confirmatory factor analysis (CFA) was utilized to test the factor structure of the adapted MIES-LIP in our sample compared to the published factor structures of the MIES.33 Results did not support the established factor structure. Analysis yielded unacceptable CFI (0.79), TLI (0.70), SRMR (0.14), and RMSEA (0.21). The unsatisfactory results of CFA warranted follow-up exploratory factor analysis (EFA) to examine the factor structure of the moral injury scales in this sample.

EFA of MIES-LIP

The factor structure of the MIES-LIP was examined using EFA. The factorability of the data was examined using the Kaiser-Meyer-Olkin Measure of Sampling Adequacy (KMO value = 0.75) and Bartlett Test of Sphericity (X² = 525.41; P < .001), both of which suggested that the data were appropriate for factor analysis. The number of factors to retain was selected based on the Kaiser criterion.⁴¹ After extraction, an Oblimin rotation was applied, given that we expected factors to be correlated. A 2-factor solution was found, explaining 65.76% of the common variance. All 9 items were retained as they had factor loadings > 0.30. Factor 1, comprised self-directed moral injury questions (3-6). Factor 2 comprised other directed moral injury questions (1, 2, 7-9) (Table 3). The factor correlation coefficient between Factor 1 and Factor 2 was 0.34, which supports utilizing an oblique rotation.

Reliability. We examined the reliability of the adapted MIES-LIP using measures of internal consistency, with both MIES-LIP factors demonstrating good reliability. The internal consistency of both factors of the MIES-LIP were found to be good (self-directed moral injury: Ω = 0.89; other-directed moral injury: Ω = 0.83).

Convergent Validity

Association between moral injury scales. A significant, moderate correlation was observed between all subscales of the MIES and MIES-LIP. Specifically, the self-directed moral injury factor of the MIES-LIP was associated with both the perceived transgressions (r = 0.41, P < .001) and the MIES perceived betrayals factors (r = 0.25, P < .05). Similarly, the other-directed moral injury factor of the MIES-LIP was associated with both the MIES perceived transgressions (r = 0.45, P < .001) and the MIES perceived betrayals factors (r = 0.45, P < .001).

Association with PTSD symptoms. All subscales of both the MIES and MIES-LIP were associated with PTSD symptom severity. The MIES perceived transgressions factor (r = 0.43, P < .001) and the perceived betrayals factor of the MIES (r = 0.39, P < .001) were moderately associated with the PCL-5. Mirroring this, the “self-directed moral injury” factor of the MIESLIP (r = 0.44, P < .001) and the “other-directed moral injury” factor of the MIES-LIP (r = 0.42, P < .001) were also positively associated with PCL-5.

Association with depression symptoms. All subscales of the MIES and MIES-LIP were also associated with depressive symptoms. The MIES perceived transgressions factor (r = 0.27, P < .01) and the MIES perceived betrayals factor (r = 0.23, P < .05) had a small association with the PHQ-9. In addition, the self-directed moral injury factor of the MIES-LIP (r = 0.40, P < .001) and the other-directed moral injury factor of the MIES-LIP (r = 0.31, P < .01) had small to moderate associations with the PCL-5.

DISCUSSION

Potentially morally injurious events appear to be a salient factor affecting legal-involved veterans. Among our sample, the vast majority of legal-involved veterans endorsed experiencing both legal- and military-related PMIEs. Witnessing or participating in a legal-related PMIE appears to be widespread among those who have experienced incarceration. The MIES-LIP yielded a 2-factor structure: self-directed moral injury and other-directed moral injury, in the evaluated population. The MIES-LIP showed similar psychometric performance to the MIES in our sample. Specifically, the MIES-LIP had good reliability and adequate convergent validity. While CFA did not confirm the anticipated factor structure of the MIES-LIP within our sample, EFA showed similarities in factor structure between the original and adapted measures. While further research and validation are needed, preliminary results show promise of the MIES-LIP in assessing legal-related moral injury.

Originally, the MIES was found to have a 2-factor structure, defined by perceived transgressions and perceived betrayals.³³ However, additional research has identified a 3-factor structure, where the betrayal factor is maintained, and the transgressions factor is divided into transgressions by others and by self.⁸ The factor structure of the MIES-LIP was more closely related to the factor structure, with transgressions by others and betrayal mapped onto the same factor (ie, other-directed moral injury).⁸ While further research is needed, it is possible that the nature of morally injurious events experienced in legal contexts are experienced more in terms of self vs other, compared to morally injurious events experienced by veterans or active-duty service members.

Accurately identifying the types of moral injury experienced in a legal context may be important for determining the differences in drivers of legal-related moral injury compared to military-related moral injury. For example, self-directed moral injury in legal contexts may include a variety of actions the individual initiated that led to conviction and incarceration (eg, a criminal offense), as well as behaviors performed or witnessed while incarcerated (eg, engaging in violence). Inconsistent with military populations where other-directed moral injury clusters with self-directed moral injury, other-directed moral injury clustered with betrayal in legal contexts in our sample. This discrepancy may result from differences in identification with the military vs legal system. When veterans witness fellow service members engaging in PMIEs (eg, physical violence towards civilians in a military setting), this may be similar to self-directed moral injury due to the veteran’s identification with the same military system as the perpetrator.⁴² When legal-involved veterans witness other incarcerated individuals engaging in PMIEs (eg, physical violence toward other inmates), this may be experienced as similar to betrayal due to lack of personal identification with the criminal-legal system. Additional research is needed to better understand how self- and other-related moral injury are associated with betrayal in legal contexts.

Another potential driver of legal-related moral injury may be culpability. In order for moral injury to occur, an individual must perceive that something has taken place that deeply violated their sense of right and wrong.¹ In terms of criminal offenses or even engaging in violent behavior while incarcerated, the potential for moral injury may differ based on whether an individual views themselves as culpable for the act(s).²⁹ This may further distinguish between self-directed and other-directed moral injury in legal contexts. In situations where the individual views themselves as culpable, self-directed moral injury may be higher. In situations where the individual does not view themselves as culpable, other-directed moral injury may be higher based on the perception that the legal system is unfairly punishing them. Further research is needed to clarify how an individual’s view of their culpability relates to moral injury, as well as to elucidate which aspects of military service and legal involvement are most closely associated with moral injury among legal-involved veterans.

While this study treated legal-related and military-related moral injury as distinct, it is possible moral injury may have a cumulative effect over time with individuals experiencing morally injurious events across different contexts (eg, military, legal involvement). This, in turn, may compound risk for moral injury. These cumulative experiences may result in increased negative outcomes such as exacerbated psychiatric symptoms, substance misuse, and elevated suicide risk. Future studies should examine differences between groups who have experienced moral injury in differing contexts, as well as those with multiple sources of moral injury.

Limitations

The sample for this study included only veterans. The number of veterans incarcerated is large and the focus on veterans also allowed for a more robust comparison of moral injury related to the legal system and the more traditional military-related moral injury. However, the generalizability of the findings to nonveterans cannot be assured. The study used a relatively small sample (N = 100), which was overwhelmingly male. Although the PCL-5 was utilized to examine traumatic stress symptoms, this measure was not anchored to a specific criterion A trauma nor was it anchored specifically to a morally injurious experience. For all participants, their most recent military service preceded their most recent legal involvement which could affect the associations between variables. Furthermore, while all participants endorsed prior legal involvement, many participants reported no combat exposure.

CONCLUSIONS

This study resulted in several key findings. First, legal-involved veterans endorsed high rates of experiencing legal-related morally injurious experiences. Second, our adapted measure displayed adequate psychometric strength and suggests that legal-related moral injury is a salient and distinct phenomenon affecting legal-involved veterans. These items may not capture all the nuances of legal-related moral injury. Qualitative interviews with legal-involved persons may help identify relevant areas of legal-related moral injury not reflected in the current instrument. The MIES-LIP represents a practical measure that may help clinicians identify and address legal-related moral injury when working with legal-involved veterans. Given the high prevalence of PMIEs among legal-involved veterans, further examination of whether current interventions for moral injury and novel treatments being developed are effective for this population is needed.

Following exposure to potentially morally injurious events (PMIEs), some individuals may experience moral injury, which represents negative psychological, social, behavioral, and occasionally spiritual impacts.¹ The consequences of PMIE exposure and moral injury are well documented. Individuals may begin to question the goodness and trustworthiness of oneself, others, or the world.¹ Examples of other sequelae include guilt, demoralization, spiritual pain, loss of trust in the self or others, and difficulties with forgiveness.^2-6 In addition, prior studies have found that moral injury is associated with an increased risk of suicidal thoughts and behaviors, posttraumatic stress disorder (PTSD) symptoms, spiritual distress, and interpersonal difficulties.^7-11

Moral injury was first conceptualized in relation to combat trauma. However in recent years it has been examined in other groups such as health care practitioners, educators, refugees, and law enforcement personnel.^12-17 Furthermore, there has been a recent call for the study of moral injury in other understudied groups. One such group is legal-involved individuals, defined as those who are currently involved or previously involved in the criminal justice system (ie, arrests, incarceration, parole, and probation).^1,18-22

Many veterans are also involved with the legal system. Specifically, veterans currently comprise about 8% of the incarcerated US population, with an estimated > 180,000 veterans in prisons or jails and even more on parole or probation.^23,24 Legal-involved veterans may be at heightened risk for homelessness, suicide, unemployment, and high prevalence rates of psychiatric diagnoses.^25-28

Limited research has explored exposure to PMIEs as part of the legal process and the resulting expression of moral injury. The circumstances leading to incarceration, interactions with the US legal system, the environment of prison itself, and the subsequent challenges faced by legal-involved individuals after release all provide ample opportunity for PMIEs to occur.¹⁸ For example, engaging in a criminal act may represent a PMIE, particularly in violent offenses that involve harm to another individual. Moreover, the process of being convicted and charged with an offense may serve as a powerful reminder of the PMIE and tie this event to the individual’s identity and future. Furthermore, the physical and social environment of prison itself (eg, being surrounded by other offenders, witnessing the perpetration of violence, participating in violence for survival) presents a myriad of opportunities for PMIEs to occur.¹⁸

The consequences of PMIEs in the context of legal involvement may also have bearing on a touchstone of moral injury: changes in one’s schema of the self and world.⁴ At a societal level, legal-involved individuals are, by definition, deemed “guilty” and held culpable for their offense, which may reinforce a negative change in one’s view of self and the world.²⁹ In line with identity theory, external negative appraisals about legal-involved individuals (eg, they are a danger to society, they cannot be trusted to do the right thing) may influence their self-perception.³⁰ Furthermore, the affective characteristics often found in the context of moral injury (eg, guilt, shame, anger, contempt) may be exacerbated by legal involvement.²⁹ Personal feelings of guilt and shame may be reinforced by receiving a verdict and sentence, as well as the negative perceptions of individuals around them (eg, disapproval from prior sources of social support). Additionally, feelings of betrayal and distrust towards the legal system may arise.

In sum, legal-involved veterans incur increased risk of moral injury due to the potential for exposure to PMIEs across multiple time points (eg, prior to military service, during military service, during arrest/sentencing, during imprisonment, and postincarceration). The stigma that accompanies legal involvement may limit access to treatment or a willingness to seek treatment for distress related to moral injury.²⁹ Additionally, repeated exposure to PMIEs and resulting moral injury may compound over time, potentially exacerbating psychosocial functioning and increasing the risk for psychosocial stressors (eg, homelessness, unemployment) and mental health disorders (eg, depression, substance misuse).³¹

Although numerous measures of moral injury have been developed, most require that respondents consider a specific context (eg, military experiences).³² Therefore, study of legal-related moral injury requires adaptation of existing instruments to the legal context. The original and most commonly used scale of moral injury is the Moral Injury Events Scale (MIES).³³ The MIES scales was originally developed to measure moral injury in military-related contexts but has since been adapted as a measure of exposure to context-specific PMIEs.³⁴

Unfortunately, there are no validated measures for assessing legal-related moral injury. Such a gap in understanding is problematic, as it may impact measurement of the prevalence of PMIEs in both clinical and research settings for this at-risk population. The goal of this study was to conduct a psychometric evaluation of an adapted version of the MIES for legal-involved persons (MIES-LIP).

METHODS

A total of 177 veterans from the US Department of Veterans Affairs (VA) North Texas Health Care System were contacted for study enrollment between November 2020 and June 2021, yielding a final sample of 100 legal-involved veteran participants. Adults aged ≥ 18 years who were US military veterans and had ≥ 1 prior felony conviction resulting in incarceration were included. Participants were excluded if they had symptoms of psychosis that would preclude meaningful participation.

The study collected data on participants’ demographic and clinical characteristics using a semistructured survey instrument. Each participant completed an instructor-led questionnaire in a session that lasted about 1.5 hours. Participants who completed the visit in person received a $50 cash voucher for their time. Participants who were unable to meet with the study coordinator in person were able to complete the visit via telephone and received a $25 digital gift card. Of the total 100 participants, 79 participants completed the interview in person, and 21 completed by telephone. No significant differences were found in assessment measures between administration methods. Written informed consent was obtained during all in-person visits. For those completing via telephone, a waiver of written informed consent was obtained. This study was approved by the VA North Texas Health Care System’s Institutional Review Board.

Measures

The Moral Injury Events Scale (MIES) is a 9-item self-report measure that assesses exposure to PMIEs.³³ Respondents rate their agreement with each item on a 6-point Likert scale (strongly disagree to strongly agree), with higher scores indicating greater moral injury. The MIES has a 2-factor structure: Factor 1 has 6 items on perceived transgressions and Factor 2 has 3 items on perceived betrayals.³³

Creation of Legal-Involved Moral Injury Measure. To create the MIES-LIP, items and instructions from the MIES were modified to address moral injury in the context of legal involvement.³³ Adaptations were finalized following consultation and approval by the authors of the original measure. Specifically, the instructions were changed to: “Please respond to these items based specifically in the context of your involvement with the legal system.” The instructions clarified that legal involvement could include experiences related to committing an offense, legal proceedings and sentencing, incarceration, or transitioning out of the legal system. This differs from the original measure, which focused on military experiences, with instructions stating: “Please respond to these items based specifically in the context of your military service (ie, events and experiences during enlistment, deployment, combat, etc).”

Other measures. The study collected data on demographic characteristics including sex, race and ethnicity, marital status, military service, combat experience, and legal involvement. PTSD symptom severity, based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), was assessed using the PTSD Checklist for DSM-5 (PCL-5).^35,36 The PCL-5 is a 20-item self-report measure in which item scores are summed to create a total score. The PCL-5 has demonstrated strong psychometric properties, including good internal consistency, test-retest reliability convergent validity, and discriminant validity.^37,38

Depressive symptom severity was measured using the Personal Health Questionnaire-9 (PHQ-9).³⁹ The PHQ-9 is a 9-item self-report measure where item scores summed to create a total score. The PHQ-9 has demonstrated strong psychometric properties, including internal consistency and test-retest reliability.³⁹

STATISTICAL METHODS

Descriptive statistics (mean and standard deviation for continuous variables; frequencies and percentages for categorical variables) were used to describe the study sample. Factor analysis was conducted to evaluate the psychometric properties of the MIES-LIP. Confirmatory factor analysis (CFA) was used to determine whether the MEIS-LIP had a similar factor structure to the MIES.⁴⁰ Criteria for fit indices used for CFA include the Comparative Fit Index (CFI; values of > 0.95 suggest good fit), Tucker-Lewis index (TLI; values of > 0.95 suggest a good fit), root mean square error of approximation (RMSEA; values of ≥ 0.06 suggest good fit), and standardized root mean square residual (SRMR; values of ≥ 0.08 suggest good fit). With insufficient fit, subsequent exploratory factor analysis was conducted using maximum likelihood estimation with an Oblimin rotation. The Kaiser rule and a scree plot were considered when defining the factor structure. Reliability was evaluated using the McDonald omega coefficient test. Convergent validity was assessed through the association between adapted measures and other clinical measures (ie, PCL-5, PHQ-9). In addition, associations between the PCL-5 and PHQ-9 were examined as they related to the MIES and MIES-LIP.

RESULTS

Table 1 describes demographic characteristics of the study sample. Rates of potentially morally injurious experiences and the expression of moral injury in the legal context are presented in Table 2. Witnessing PMIEs while in the legal system was nearly ubiquitous, with > 90% of the sample endorsing this experience. More than half of the sample also endorsed engaging in morally injurious behavior by commission or omission, as well as experiencing betrayal while involved with the legal system.

Factor Analysis

Confirmatory factor analysis (CFA) was utilized to test the factor structure of the adapted MIES-LIP in our sample compared to the published factor structures of the MIES.33 Results did not support the established factor structure. Analysis yielded unacceptable CFI (0.79), TLI (0.70), SRMR (0.14), and RMSEA (0.21). The unsatisfactory results of CFA warranted follow-up exploratory factor analysis (EFA) to examine the factor structure of the moral injury scales in this sample.

EFA of MIES-LIP

The factor structure of the MIES-LIP was examined using EFA. The factorability of the data was examined using the Kaiser-Meyer-Olkin Measure of Sampling Adequacy (KMO value = 0.75) and Bartlett Test of Sphericity (X² = 525.41; P < .001), both of which suggested that the data were appropriate for factor analysis. The number of factors to retain was selected based on the Kaiser criterion.⁴¹ After extraction, an Oblimin rotation was applied, given that we expected factors to be correlated. A 2-factor solution was found, explaining 65.76% of the common variance. All 9 items were retained as they had factor loadings > 0.30. Factor 1, comprised self-directed moral injury questions (3-6). Factor 2 comprised other directed moral injury questions (1, 2, 7-9) (Table 3). The factor correlation coefficient between Factor 1 and Factor 2 was 0.34, which supports utilizing an oblique rotation.

Reliability. We examined the reliability of the adapted MIES-LIP using measures of internal consistency, with both MIES-LIP factors demonstrating good reliability. The internal consistency of both factors of the MIES-LIP were found to be good (self-directed moral injury: Ω = 0.89; other-directed moral injury: Ω = 0.83).

Convergent Validity

Association between moral injury scales. A significant, moderate correlation was observed between all subscales of the MIES and MIES-LIP. Specifically, the self-directed moral injury factor of the MIES-LIP was associated with both the perceived transgressions (r = 0.41, P < .001) and the MIES perceived betrayals factors (r = 0.25, P < .05). Similarly, the other-directed moral injury factor of the MIES-LIP was associated with both the MIES perceived transgressions (r = 0.45, P < .001) and the MIES perceived betrayals factors (r = 0.45, P < .001).

Association with PTSD symptoms. All subscales of both the MIES and MIES-LIP were associated with PTSD symptom severity. The MIES perceived transgressions factor (r = 0.43, P < .001) and the perceived betrayals factor of the MIES (r = 0.39, P < .001) were moderately associated with the PCL-5. Mirroring this, the “self-directed moral injury” factor of the MIESLIP (r = 0.44, P < .001) and the “other-directed moral injury” factor of the MIES-LIP (r = 0.42, P < .001) were also positively associated with PCL-5.

Association with depression symptoms. All subscales of the MIES and MIES-LIP were also associated with depressive symptoms. The MIES perceived transgressions factor (r = 0.27, P < .01) and the MIES perceived betrayals factor (r = 0.23, P < .05) had a small association with the PHQ-9. In addition, the self-directed moral injury factor of the MIES-LIP (r = 0.40, P < .001) and the other-directed moral injury factor of the MIES-LIP (r = 0.31, P < .01) had small to moderate associations with the PCL-5.

DISCUSSION

Potentially morally injurious events appear to be a salient factor affecting legal-involved veterans. Among our sample, the vast majority of legal-involved veterans endorsed experiencing both legal- and military-related PMIEs. Witnessing or participating in a legal-related PMIE appears to be widespread among those who have experienced incarceration. The MIES-LIP yielded a 2-factor structure: self-directed moral injury and other-directed moral injury, in the evaluated population. The MIES-LIP showed similar psychometric performance to the MIES in our sample. Specifically, the MIES-LIP had good reliability and adequate convergent validity. While CFA did not confirm the anticipated factor structure of the MIES-LIP within our sample, EFA showed similarities in factor structure between the original and adapted measures. While further research and validation are needed, preliminary results show promise of the MIES-LIP in assessing legal-related moral injury.

Originally, the MIES was found to have a 2-factor structure, defined by perceived transgressions and perceived betrayals.³³ However, additional research has identified a 3-factor structure, where the betrayal factor is maintained, and the transgressions factor is divided into transgressions by others and by self.⁸ The factor structure of the MIES-LIP was more closely related to the factor structure, with transgressions by others and betrayal mapped onto the same factor (ie, other-directed moral injury).⁸ While further research is needed, it is possible that the nature of morally injurious events experienced in legal contexts are experienced more in terms of self vs other, compared to morally injurious events experienced by veterans or active-duty service members.

Accurately identifying the types of moral injury experienced in a legal context may be important for determining the differences in drivers of legal-related moral injury compared to military-related moral injury. For example, self-directed moral injury in legal contexts may include a variety of actions the individual initiated that led to conviction and incarceration (eg, a criminal offense), as well as behaviors performed or witnessed while incarcerated (eg, engaging in violence). Inconsistent with military populations where other-directed moral injury clusters with self-directed moral injury, other-directed moral injury clustered with betrayal in legal contexts in our sample. This discrepancy may result from differences in identification with the military vs legal system. When veterans witness fellow service members engaging in PMIEs (eg, physical violence towards civilians in a military setting), this may be similar to self-directed moral injury due to the veteran’s identification with the same military system as the perpetrator.⁴² When legal-involved veterans witness other incarcerated individuals engaging in PMIEs (eg, physical violence toward other inmates), this may be experienced as similar to betrayal due to lack of personal identification with the criminal-legal system. Additional research is needed to better understand how self- and other-related moral injury are associated with betrayal in legal contexts.

Another potential driver of legal-related moral injury may be culpability. In order for moral injury to occur, an individual must perceive that something has taken place that deeply violated their sense of right and wrong.¹ In terms of criminal offenses or even engaging in violent behavior while incarcerated, the potential for moral injury may differ based on whether an individual views themselves as culpable for the act(s).²⁹ This may further distinguish between self-directed and other-directed moral injury in legal contexts. In situations where the individual views themselves as culpable, self-directed moral injury may be higher. In situations where the individual does not view themselves as culpable, other-directed moral injury may be higher based on the perception that the legal system is unfairly punishing them. Further research is needed to clarify how an individual’s view of their culpability relates to moral injury, as well as to elucidate which aspects of military service and legal involvement are most closely associated with moral injury among legal-involved veterans.

While this study treated legal-related and military-related moral injury as distinct, it is possible moral injury may have a cumulative effect over time with individuals experiencing morally injurious events across different contexts (eg, military, legal involvement). This, in turn, may compound risk for moral injury. These cumulative experiences may result in increased negative outcomes such as exacerbated psychiatric symptoms, substance misuse, and elevated suicide risk. Future studies should examine differences between groups who have experienced moral injury in differing contexts, as well as those with multiple sources of moral injury.

Limitations

The sample for this study included only veterans. The number of veterans incarcerated is large and the focus on veterans also allowed for a more robust comparison of moral injury related to the legal system and the more traditional military-related moral injury. However, the generalizability of the findings to nonveterans cannot be assured. The study used a relatively small sample (N = 100), which was overwhelmingly male. Although the PCL-5 was utilized to examine traumatic stress symptoms, this measure was not anchored to a specific criterion A trauma nor was it anchored specifically to a morally injurious experience. For all participants, their most recent military service preceded their most recent legal involvement which could affect the associations between variables. Furthermore, while all participants endorsed prior legal involvement, many participants reported no combat exposure.

CONCLUSIONS

This study resulted in several key findings. First, legal-involved veterans endorsed high rates of experiencing legal-related morally injurious experiences. Second, our adapted measure displayed adequate psychometric strength and suggests that legal-related moral injury is a salient and distinct phenomenon affecting legal-involved veterans. These items may not capture all the nuances of legal-related moral injury. Qualitative interviews with legal-involved persons may help identify relevant areas of legal-related moral injury not reflected in the current instrument. The MIES-LIP represents a practical measure that may help clinicians identify and address legal-related moral injury when working with legal-involved veterans. Given the high prevalence of PMIEs among legal-involved veterans, further examination of whether current interventions for moral injury and novel treatments being developed are effective for this population is needed.

Following exposure to potentially morally injurious events (PMIEs), some individuals may experience moral injury, which represents negative psychological, social, behavioral, and occasionally spiritual impacts.¹ The consequences of PMIE exposure and moral injury are well documented. Individuals may begin to question the goodness and trustworthiness of oneself, others, or the world.¹ Examples of other sequelae include guilt, demoralization, spiritual pain, loss of trust in the self or others, and difficulties with forgiveness.^2-6 In addition, prior studies have found that moral injury is associated with an increased risk of suicidal thoughts and behaviors, posttraumatic stress disorder (PTSD) symptoms, spiritual distress, and interpersonal difficulties.^7-11

Moral injury was first conceptualized in relation to combat trauma. However in recent years it has been examined in other groups such as health care practitioners, educators, refugees, and law enforcement personnel.^12-17 Furthermore, there has been a recent call for the study of moral injury in other understudied groups. One such group is legal-involved individuals, defined as those who are currently involved or previously involved in the criminal justice system (ie, arrests, incarceration, parole, and probation).^1,18-22

Many veterans are also involved with the legal system. Specifically, veterans currently comprise about 8% of the incarcerated US population, with an estimated > 180,000 veterans in prisons or jails and even more on parole or probation.^23,24 Legal-involved veterans may be at heightened risk for homelessness, suicide, unemployment, and high prevalence rates of psychiatric diagnoses.^25-28

Limited research has explored exposure to PMIEs as part of the legal process and the resulting expression of moral injury. The circumstances leading to incarceration, interactions with the US legal system, the environment of prison itself, and the subsequent challenges faced by legal-involved individuals after release all provide ample opportunity for PMIEs to occur.¹⁸ For example, engaging in a criminal act may represent a PMIE, particularly in violent offenses that involve harm to another individual. Moreover, the process of being convicted and charged with an offense may serve as a powerful reminder of the PMIE and tie this event to the individual’s identity and future. Furthermore, the physical and social environment of prison itself (eg, being surrounded by other offenders, witnessing the perpetration of violence, participating in violence for survival) presents a myriad of opportunities for PMIEs to occur.¹⁸

The consequences of PMIEs in the context of legal involvement may also have bearing on a touchstone of moral injury: changes in one’s schema of the self and world.⁴ At a societal level, legal-involved individuals are, by definition, deemed “guilty” and held culpable for their offense, which may reinforce a negative change in one’s view of self and the world.²⁹ In line with identity theory, external negative appraisals about legal-involved individuals (eg, they are a danger to society, they cannot be trusted to do the right thing) may influence their self-perception.³⁰ Furthermore, the affective characteristics often found in the context of moral injury (eg, guilt, shame, anger, contempt) may be exacerbated by legal involvement.²⁹ Personal feelings of guilt and shame may be reinforced by receiving a verdict and sentence, as well as the negative perceptions of individuals around them (eg, disapproval from prior sources of social support). Additionally, feelings of betrayal and distrust towards the legal system may arise.

In sum, legal-involved veterans incur increased risk of moral injury due to the potential for exposure to PMIEs across multiple time points (eg, prior to military service, during military service, during arrest/sentencing, during imprisonment, and postincarceration). The stigma that accompanies legal involvement may limit access to treatment or a willingness to seek treatment for distress related to moral injury.²⁹ Additionally, repeated exposure to PMIEs and resulting moral injury may compound over time, potentially exacerbating psychosocial functioning and increasing the risk for psychosocial stressors (eg, homelessness, unemployment) and mental health disorders (eg, depression, substance misuse).³¹

Although numerous measures of moral injury have been developed, most require that respondents consider a specific context (eg, military experiences).³² Therefore, study of legal-related moral injury requires adaptation of existing instruments to the legal context. The original and most commonly used scale of moral injury is the Moral Injury Events Scale (MIES).³³ The MIES scales was originally developed to measure moral injury in military-related contexts but has since been adapted as a measure of exposure to context-specific PMIEs.³⁴

Unfortunately, there are no validated measures for assessing legal-related moral injury. Such a gap in understanding is problematic, as it may impact measurement of the prevalence of PMIEs in both clinical and research settings for this at-risk population. The goal of this study was to conduct a psychometric evaluation of an adapted version of the MIES for legal-involved persons (MIES-LIP).

METHODS

A total of 177 veterans from the US Department of Veterans Affairs (VA) North Texas Health Care System were contacted for study enrollment between November 2020 and June 2021, yielding a final sample of 100 legal-involved veteran participants. Adults aged ≥ 18 years who were US military veterans and had ≥ 1 prior felony conviction resulting in incarceration were included. Participants were excluded if they had symptoms of psychosis that would preclude meaningful participation.

The study collected data on participants’ demographic and clinical characteristics using a semistructured survey instrument. Each participant completed an instructor-led questionnaire in a session that lasted about 1.5 hours. Participants who completed the visit in person received a $50 cash voucher for their time. Participants who were unable to meet with the study coordinator in person were able to complete the visit via telephone and received a $25 digital gift card. Of the total 100 participants, 79 participants completed the interview in person, and 21 completed by telephone. No significant differences were found in assessment measures between administration methods. Written informed consent was obtained during all in-person visits. For those completing via telephone, a waiver of written informed consent was obtained. This study was approved by the VA North Texas Health Care System’s Institutional Review Board.

Measures

The Moral Injury Events Scale (MIES) is a 9-item self-report measure that assesses exposure to PMIEs.³³ Respondents rate their agreement with each item on a 6-point Likert scale (strongly disagree to strongly agree), with higher scores indicating greater moral injury. The MIES has a 2-factor structure: Factor 1 has 6 items on perceived transgressions and Factor 2 has 3 items on perceived betrayals.³³

Creation of Legal-Involved Moral Injury Measure. To create the MIES-LIP, items and instructions from the MIES were modified to address moral injury in the context of legal involvement.³³ Adaptations were finalized following consultation and approval by the authors of the original measure. Specifically, the instructions were changed to: “Please respond to these items based specifically in the context of your involvement with the legal system.” The instructions clarified that legal involvement could include experiences related to committing an offense, legal proceedings and sentencing, incarceration, or transitioning out of the legal system. This differs from the original measure, which focused on military experiences, with instructions stating: “Please respond to these items based specifically in the context of your military service (ie, events and experiences during enlistment, deployment, combat, etc).”

Other measures. The study collected data on demographic characteristics including sex, race and ethnicity, marital status, military service, combat experience, and legal involvement. PTSD symptom severity, based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), was assessed using the PTSD Checklist for DSM-5 (PCL-5).^35,36 The PCL-5 is a 20-item self-report measure in which item scores are summed to create a total score. The PCL-5 has demonstrated strong psychometric properties, including good internal consistency, test-retest reliability convergent validity, and discriminant validity.^37,38

Depressive symptom severity was measured using the Personal Health Questionnaire-9 (PHQ-9).³⁹ The PHQ-9 is a 9-item self-report measure where item scores summed to create a total score. The PHQ-9 has demonstrated strong psychometric properties, including internal consistency and test-retest reliability.³⁹

STATISTICAL METHODS

Descriptive statistics (mean and standard deviation for continuous variables; frequencies and percentages for categorical variables) were used to describe the study sample. Factor analysis was conducted to evaluate the psychometric properties of the MIES-LIP. Confirmatory factor analysis (CFA) was used to determine whether the MEIS-LIP had a similar factor structure to the MIES.⁴⁰ Criteria for fit indices used for CFA include the Comparative Fit Index (CFI; values of > 0.95 suggest good fit), Tucker-Lewis index (TLI; values of > 0.95 suggest a good fit), root mean square error of approximation (RMSEA; values of ≥ 0.06 suggest good fit), and standardized root mean square residual (SRMR; values of ≥ 0.08 suggest good fit). With insufficient fit, subsequent exploratory factor analysis was conducted using maximum likelihood estimation with an Oblimin rotation. The Kaiser rule and a scree plot were considered when defining the factor structure. Reliability was evaluated using the McDonald omega coefficient test. Convergent validity was assessed through the association between adapted measures and other clinical measures (ie, PCL-5, PHQ-9). In addition, associations between the PCL-5 and PHQ-9 were examined as they related to the MIES and MIES-LIP.

RESULTS

Table 1 describes demographic characteristics of the study sample. Rates of potentially morally injurious experiences and the expression of moral injury in the legal context are presented in Table 2. Witnessing PMIEs while in the legal system was nearly ubiquitous, with > 90% of the sample endorsing this experience. More than half of the sample also endorsed engaging in morally injurious behavior by commission or omission, as well as experiencing betrayal while involved with the legal system.

Factor Analysis

Confirmatory factor analysis (CFA) was utilized to test the factor structure of the adapted MIES-LIP in our sample compared to the published factor structures of the MIES.33 Results did not support the established factor structure. Analysis yielded unacceptable CFI (0.79), TLI (0.70), SRMR (0.14), and RMSEA (0.21). The unsatisfactory results of CFA warranted follow-up exploratory factor analysis (EFA) to examine the factor structure of the moral injury scales in this sample.

EFA of MIES-LIP

The factor structure of the MIES-LIP was examined using EFA. The factorability of the data was examined using the Kaiser-Meyer-Olkin Measure of Sampling Adequacy (KMO value = 0.75) and Bartlett Test of Sphericity (X² = 525.41; P < .001), both of which suggested that the data were appropriate for factor analysis. The number of factors to retain was selected based on the Kaiser criterion.⁴¹ After extraction, an Oblimin rotation was applied, given that we expected factors to be correlated. A 2-factor solution was found, explaining 65.76% of the common variance. All 9 items were retained as they had factor loadings > 0.30. Factor 1, comprised self-directed moral injury questions (3-6). Factor 2 comprised other directed moral injury questions (1, 2, 7-9) (Table 3). The factor correlation coefficient between Factor 1 and Factor 2 was 0.34, which supports utilizing an oblique rotation.

Reliability. We examined the reliability of the adapted MIES-LIP using measures of internal consistency, with both MIES-LIP factors demonstrating good reliability. The internal consistency of both factors of the MIES-LIP were found to be good (self-directed moral injury: Ω = 0.89; other-directed moral injury: Ω = 0.83).

Convergent Validity

Association between moral injury scales. A significant, moderate correlation was observed between all subscales of the MIES and MIES-LIP. Specifically, the self-directed moral injury factor of the MIES-LIP was associated with both the perceived transgressions (r = 0.41, P < .001) and the MIES perceived betrayals factors (r = 0.25, P < .05). Similarly, the other-directed moral injury factor of the MIES-LIP was associated with both the MIES perceived transgressions (r = 0.45, P < .001) and the MIES perceived betrayals factors (r = 0.45, P < .001).

Association with PTSD symptoms. All subscales of both the MIES and MIES-LIP were associated with PTSD symptom severity. The MIES perceived transgressions factor (r = 0.43, P < .001) and the perceived betrayals factor of the MIES (r = 0.39, P < .001) were moderately associated with the PCL-5. Mirroring this, the “self-directed moral injury” factor of the MIESLIP (r = 0.44, P < .001) and the “other-directed moral injury” factor of the MIES-LIP (r = 0.42, P < .001) were also positively associated with PCL-5.

Association with depression symptoms. All subscales of the MIES and MIES-LIP were also associated with depressive symptoms. The MIES perceived transgressions factor (r = 0.27, P < .01) and the MIES perceived betrayals factor (r = 0.23, P < .05) had a small association with the PHQ-9. In addition, the self-directed moral injury factor of the MIES-LIP (r = 0.40, P < .001) and the other-directed moral injury factor of the MIES-LIP (r = 0.31, P < .01) had small to moderate associations with the PCL-5.

DISCUSSION

Potentially morally injurious events appear to be a salient factor affecting legal-involved veterans. Among our sample, the vast majority of legal-involved veterans endorsed experiencing both legal- and military-related PMIEs. Witnessing or participating in a legal-related PMIE appears to be widespread among those who have experienced incarceration. The MIES-LIP yielded a 2-factor structure: self-directed moral injury and other-directed moral injury, in the evaluated population. The MIES-LIP showed similar psychometric performance to the MIES in our sample. Specifically, the MIES-LIP had good reliability and adequate convergent validity. While CFA did not confirm the anticipated factor structure of the MIES-LIP within our sample, EFA showed similarities in factor structure between the original and adapted measures. While further research and validation are needed, preliminary results show promise of the MIES-LIP in assessing legal-related moral injury.

Originally, the MIES was found to have a 2-factor structure, defined by perceived transgressions and perceived betrayals.³³ However, additional research has identified a 3-factor structure, where the betrayal factor is maintained, and the transgressions factor is divided into transgressions by others and by self.⁸ The factor structure of the MIES-LIP was more closely related to the factor structure, with transgressions by others and betrayal mapped onto the same factor (ie, other-directed moral injury).⁸ While further research is needed, it is possible that the nature of morally injurious events experienced in legal contexts are experienced more in terms of self vs other, compared to morally injurious events experienced by veterans or active-duty service members.

Accurately identifying the types of moral injury experienced in a legal context may be important for determining the differences in drivers of legal-related moral injury compared to military-related moral injury. For example, self-directed moral injury in legal contexts may include a variety of actions the individual initiated that led to conviction and incarceration (eg, a criminal offense), as well as behaviors performed or witnessed while incarcerated (eg, engaging in violence). Inconsistent with military populations where other-directed moral injury clusters with self-directed moral injury, other-directed moral injury clustered with betrayal in legal contexts in our sample. This discrepancy may result from differences in identification with the military vs legal system. When veterans witness fellow service members engaging in PMIEs (eg, physical violence towards civilians in a military setting), this may be similar to self-directed moral injury due to the veteran’s identification with the same military system as the perpetrator.⁴² When legal-involved veterans witness other incarcerated individuals engaging in PMIEs (eg, physical violence toward other inmates), this may be experienced as similar to betrayal due to lack of personal identification with the criminal-legal system. Additional research is needed to better understand how self- and other-related moral injury are associated with betrayal in legal contexts.

Another potential driver of legal-related moral injury may be culpability. In order for moral injury to occur, an individual must perceive that something has taken place that deeply violated their sense of right and wrong.¹ In terms of criminal offenses or even engaging in violent behavior while incarcerated, the potential for moral injury may differ based on whether an individual views themselves as culpable for the act(s).²⁹ This may further distinguish between self-directed and other-directed moral injury in legal contexts. In situations where the individual views themselves as culpable, self-directed moral injury may be higher. In situations where the individual does not view themselves as culpable, other-directed moral injury may be higher based on the perception that the legal system is unfairly punishing them. Further research is needed to clarify how an individual’s view of their culpability relates to moral injury, as well as to elucidate which aspects of military service and legal involvement are most closely associated with moral injury among legal-involved veterans.

While this study treated legal-related and military-related moral injury as distinct, it is possible moral injury may have a cumulative effect over time with individuals experiencing morally injurious events across different contexts (eg, military, legal involvement). This, in turn, may compound risk for moral injury. These cumulative experiences may result in increased negative outcomes such as exacerbated psychiatric symptoms, substance misuse, and elevated suicide risk. Future studies should examine differences between groups who have experienced moral injury in differing contexts, as well as those with multiple sources of moral injury.

Limitations

The sample for this study included only veterans. The number of veterans incarcerated is large and the focus on veterans also allowed for a more robust comparison of moral injury related to the legal system and the more traditional military-related moral injury. However, the generalizability of the findings to nonveterans cannot be assured. The study used a relatively small sample (N = 100), which was overwhelmingly male. Although the PCL-5 was utilized to examine traumatic stress symptoms, this measure was not anchored to a specific criterion A trauma nor was it anchored specifically to a morally injurious experience. For all participants, their most recent military service preceded their most recent legal involvement which could affect the associations between variables. Furthermore, while all participants endorsed prior legal involvement, many participants reported no combat exposure.

CONCLUSIONS

This study resulted in several key findings. First, legal-involved veterans endorsed high rates of experiencing legal-related morally injurious experiences. Second, our adapted measure displayed adequate psychometric strength and suggests that legal-related moral injury is a salient and distinct phenomenon affecting legal-involved veterans. These items may not capture all the nuances of legal-related moral injury. Qualitative interviews with legal-involved persons may help identify relevant areas of legal-related moral injury not reflected in the current instrument. The MIES-LIP represents a practical measure that may help clinicians identify and address legal-related moral injury when working with legal-involved veterans. Given the high prevalence of PMIEs among legal-involved veterans, further examination of whether current interventions for moral injury and novel treatments being developed are effective for this population is needed.