Federal Practitioner

A 53-year-old male veteran with a history of heavy tobacco and alcohol use presented with abdominal pain, emesis, and no bowel movements for 2 days. He had no history of surgical procedures, malignancies, diverticulitis, inflammatory bowel disease, traveling abroad, parasitic infections, tuberculosis exposure, or hospital admissions for abdominal pain. He reported experiencing no flushing, diarrhea, or cardiac symptoms. His medical history included hypertension, depression, and osteoarthritis. His vital signs were within normal limits.

A physical examination revealed a distended abdomen with mild tenderness. He had no inguinal or ventral hernias. He also had no abnormal skin lesions. A rectal examination did not reveal any masses or blood. His laboratory values were normal. X-ray and computed tomography (CT) scan revealed dilated loops of proximal small bowel, mild wall thickening in a segment of the midileum, and narrowing of the distal small bowel suggestive of a partial small bowel obstruction (Figure 1). A 1-cm nonspecific omental nodule also was seen on the CT scan, but no enlarged lymph nodes or mesenteric calcifications were seen. There was no thickening of the terminal ileum.

The patient underwent an exploratory laparotomy, which revealed no adhesions. In the midileum there was an area of thickened bowel with some nodularity associated with the thickness, but no discrete mass. In the mesentery there were multiple hard, white, calcified nodules, with the majority clustered near the thickened ileal segment. There also was a 1-cm hard, peritoneal mass on the anterior abdominal wall. The segment of thickened ileum, the adjacent mesentery, and the peritoneal nodule were resected.

Pathologic examination of the resected tissue showed immunohistochemical stains that were positive for CD79a, CD10, and BCL-2 and negative for CD23, CD5, and CD3. Nineteen mesenteric lymph nodes were negative for malignancy. The postoperative staging positron emission tomography (PET) scan did not reveal any fluorodeoxyglucose avid masses anywhere else, and bone marrow biopsy showed no infiltration.

• What is your diagnosis?
• How would you treat this patient?
   

   

Diagnosis

Based on the pathologic examination of the resected tissue and immunohistochemical stains, this patient was diagnosed with malignant non-Hodgkin B-cell lymphoma, follicular type, grade 1. PET scan and bone marrow biopsy revealed no other lesions, making this a primary lymphoma of the small intestine. The resected tissue showed negative margins and negative lymph nodes, indicating the full extent of the patient’s tumor was removed. He then underwent nasogastric tube decompression and IV fluid resuscitation. Two days later, he had a large bowel movement, and his abdominal pain resolved. He was provided the treatment options of observation only, radiation therapy, or rituximab treatment. Based on the high risk of enteritis following radiation therapy, the patient elected for observation only, with a repeat scan in 6 months. He also was counseled on alcohol and tobacco cessation. At the 6-month oncology follow-up, the patient showed no evidence of disease recurrence.

Discussion

Small bowel obstruction accounts for about 350,000 hospitalizations annually in the US.¹ The incidence is equal in men and women and can present at any age.^2,3 Patients typically present nonspecifically, with intermittent, colicky abdominal pain, nausea, vomiting, and constipation.² A physical examination may reveal abdominal distention, rigidity, and hypoactive or absent bowel sounds.¹ The 2 most common etiologies of small bowel obstruction are adhesions from prior abdominal surgery (65%) and incarcerated inguinal hernias (10%).¹ However, in a patient presenting with a small bowel obstruction in a surgically naïve abdomen with no hernias, a more detailed history covering current malignancies, past hospital admissions for abdominal pains, pelvic inflammatory disease, diverticulitis, inflammatory bowel disease, and risks for parasite infection must be taken. The differential should include intraluminal causes, including small bowel malignancy, which accounts for 5% of small bowel obstructions,¹ as well as extraluminal causes, including adhesions from diverticulitis, Meckel diverticulum, Ladd bands, and undiagnosed prior appendicitis.

To provide a tissue diagnosis and definitive treatment, surgical exploration was needed for this patient. Exploratory laparotomy revealed an area of thickened ileum and calcified nodules in its mesentery. Pathologic examination of the resected tissue revealed large lymphoid nodules in a follicular pattern with coarse chromatin (Figure 2). Taken together with the immunohistochemical stains, this was consistent with malignant B-cell non-Hodgkin lymphoma, follicular type, grade 1.

Small bowel malignancy accounts for > 5% of all gastrointestinal tumors.⁴ Of these, small bowel neuroendocrine tumors are the most common, followed by adenocarcinomas, lymphomas, and stromal tumors.⁴ Primary follicular lymphoma (PFL) is a B-cell non-Hodgkin lymphoma, and comprises between 3.8% and 11% of gastrointestinal lymphomas, commonly in the duodenum and terminal ileum.⁵

PFL typically occurs in middle-aged females and can be difficult to diagnose, as most patients are asymptomatic or present with unspecified abdominal pain. Many are diagnosed incidentally when endoscopy biopsies are performed for other reasons.^4,5 Histologically, PFL is composed of a mixed population of small (centrocytes) and large (centroblasts) lymphoid cells, with higher proportions of centroblasts corresponding to a higher grade lymphoma.⁶ The classic immunophenotype of PFL shows coexpression of CD79a (or CD20), CD10, and BCL-2; however, in rare cases, low-grade PFL may stain negative for BCL-2 and have diminished staining for CD10 in interfollicular areas.⁷

PFL generally carries a favorable prognosis. Most patients achieving complete disease regression or stable disease following treatment and a low recurrence rate. Treatment can include surgical resection, radiation, rituximab therapy, chemotherapy, or observation.⁸ Patient also should be counseled in alcohol and tobacco cessation to reduce recurrence risk.

Other small bowel malignancies may present as small bowel obstructions as well. Neuroendocrine tumors and adenocarcinomas are both more common than small bowel lymphomas and can present as small bowel obstruction. However, neuroendocrine tumors are derived from serotonin-expressing enterochromaffin cells of the midgut and often present with classic carcinoid syndrome symptoms, including diarrhea, flushing, and right heart fibrosis, which the patient lacked.⁹ Immunohistology of small bowel adenocarcinoma often shows expression of MUC1 or MUC5AC with tumor markers CEA and CA 19-9.¹⁰

Primary intestinal melanoma, another small bowel malignancy, is extremely rare. More commonly, the etiology of intestinal melanoma is cutaneous melanoma that metastasizes to the gastrointestinal tract.¹¹ This patient had no skin lesions to suggest metastatic melanoma. With intestinal melanoma, immunohistochemical evaluation may show S-100, the most sensitive marker for melanoma, or HMB-45, MART-1/Melan-A, tyrosinase, and MITF.¹²

Conclusion

This case is notable because it highlights the importance of examining the cause of small bowel obstruction in a surgically naïve abdomen, as exploration led to the discovery and curative treatment of a primary intestinal malignancy. It also underscores the nonspecific presentation that PFLs of the small intestine can have and the importance of understanding the different histopathology and immunohistochemical profiles of small bowel malignancies.

A 53-year-old male veteran with a history of heavy tobacco and alcohol use presented with abdominal pain, emesis, and no bowel movements for 2 days. He had no history of surgical procedures, malignancies, diverticulitis, inflammatory bowel disease, traveling abroad, parasitic infections, tuberculosis exposure, or hospital admissions for abdominal pain. He reported experiencing no flushing, diarrhea, or cardiac symptoms. His medical history included hypertension, depression, and osteoarthritis. His vital signs were within normal limits.

A physical examination revealed a distended abdomen with mild tenderness. He had no inguinal or ventral hernias. He also had no abnormal skin lesions. A rectal examination did not reveal any masses or blood. His laboratory values were normal. X-ray and computed tomography (CT) scan revealed dilated loops of proximal small bowel, mild wall thickening in a segment of the midileum, and narrowing of the distal small bowel suggestive of a partial small bowel obstruction (Figure 1). A 1-cm nonspecific omental nodule also was seen on the CT scan, but no enlarged lymph nodes or mesenteric calcifications were seen. There was no thickening of the terminal ileum.

The patient underwent an exploratory laparotomy, which revealed no adhesions. In the midileum there was an area of thickened bowel with some nodularity associated with the thickness, but no discrete mass. In the mesentery there were multiple hard, white, calcified nodules, with the majority clustered near the thickened ileal segment. There also was a 1-cm hard, peritoneal mass on the anterior abdominal wall. The segment of thickened ileum, the adjacent mesentery, and the peritoneal nodule were resected.

Pathologic examination of the resected tissue showed immunohistochemical stains that were positive for CD79a, CD10, and BCL-2 and negative for CD23, CD5, and CD3. Nineteen mesenteric lymph nodes were negative for malignancy. The postoperative staging positron emission tomography (PET) scan did not reveal any fluorodeoxyglucose avid masses anywhere else, and bone marrow biopsy showed no infiltration.

• What is your diagnosis?
• How would you treat this patient?
   

   

Diagnosis

Based on the pathologic examination of the resected tissue and immunohistochemical stains, this patient was diagnosed with malignant non-Hodgkin B-cell lymphoma, follicular type, grade 1. PET scan and bone marrow biopsy revealed no other lesions, making this a primary lymphoma of the small intestine. The resected tissue showed negative margins and negative lymph nodes, indicating the full extent of the patient’s tumor was removed. He then underwent nasogastric tube decompression and IV fluid resuscitation. Two days later, he had a large bowel movement, and his abdominal pain resolved. He was provided the treatment options of observation only, radiation therapy, or rituximab treatment. Based on the high risk of enteritis following radiation therapy, the patient elected for observation only, with a repeat scan in 6 months. He also was counseled on alcohol and tobacco cessation. At the 6-month oncology follow-up, the patient showed no evidence of disease recurrence.

Discussion

Small bowel obstruction accounts for about 350,000 hospitalizations annually in the US.¹ The incidence is equal in men and women and can present at any age.^2,3 Patients typically present nonspecifically, with intermittent, colicky abdominal pain, nausea, vomiting, and constipation.² A physical examination may reveal abdominal distention, rigidity, and hypoactive or absent bowel sounds.¹ The 2 most common etiologies of small bowel obstruction are adhesions from prior abdominal surgery (65%) and incarcerated inguinal hernias (10%).¹ However, in a patient presenting with a small bowel obstruction in a surgically naïve abdomen with no hernias, a more detailed history covering current malignancies, past hospital admissions for abdominal pains, pelvic inflammatory disease, diverticulitis, inflammatory bowel disease, and risks for parasite infection must be taken. The differential should include intraluminal causes, including small bowel malignancy, which accounts for 5% of small bowel obstructions,¹ as well as extraluminal causes, including adhesions from diverticulitis, Meckel diverticulum, Ladd bands, and undiagnosed prior appendicitis.

To provide a tissue diagnosis and definitive treatment, surgical exploration was needed for this patient. Exploratory laparotomy revealed an area of thickened ileum and calcified nodules in its mesentery. Pathologic examination of the resected tissue revealed large lymphoid nodules in a follicular pattern with coarse chromatin (Figure 2). Taken together with the immunohistochemical stains, this was consistent with malignant B-cell non-Hodgkin lymphoma, follicular type, grade 1.

Small bowel malignancy accounts for > 5% of all gastrointestinal tumors.⁴ Of these, small bowel neuroendocrine tumors are the most common, followed by adenocarcinomas, lymphomas, and stromal tumors.⁴ Primary follicular lymphoma (PFL) is a B-cell non-Hodgkin lymphoma, and comprises between 3.8% and 11% of gastrointestinal lymphomas, commonly in the duodenum and terminal ileum.⁵

PFL typically occurs in middle-aged females and can be difficult to diagnose, as most patients are asymptomatic or present with unspecified abdominal pain. Many are diagnosed incidentally when endoscopy biopsies are performed for other reasons.^4,5 Histologically, PFL is composed of a mixed population of small (centrocytes) and large (centroblasts) lymphoid cells, with higher proportions of centroblasts corresponding to a higher grade lymphoma.⁶ The classic immunophenotype of PFL shows coexpression of CD79a (or CD20), CD10, and BCL-2; however, in rare cases, low-grade PFL may stain negative for BCL-2 and have diminished staining for CD10 in interfollicular areas.⁷

PFL generally carries a favorable prognosis. Most patients achieving complete disease regression or stable disease following treatment and a low recurrence rate. Treatment can include surgical resection, radiation, rituximab therapy, chemotherapy, or observation.⁸ Patient also should be counseled in alcohol and tobacco cessation to reduce recurrence risk.

Other small bowel malignancies may present as small bowel obstructions as well. Neuroendocrine tumors and adenocarcinomas are both more common than small bowel lymphomas and can present as small bowel obstruction. However, neuroendocrine tumors are derived from serotonin-expressing enterochromaffin cells of the midgut and often present with classic carcinoid syndrome symptoms, including diarrhea, flushing, and right heart fibrosis, which the patient lacked.⁹ Immunohistology of small bowel adenocarcinoma often shows expression of MUC1 or MUC5AC with tumor markers CEA and CA 19-9.¹⁰

Primary intestinal melanoma, another small bowel malignancy, is extremely rare. More commonly, the etiology of intestinal melanoma is cutaneous melanoma that metastasizes to the gastrointestinal tract.¹¹ This patient had no skin lesions to suggest metastatic melanoma. With intestinal melanoma, immunohistochemical evaluation may show S-100, the most sensitive marker for melanoma, or HMB-45, MART-1/Melan-A, tyrosinase, and MITF.¹²

Conclusion

This case is notable because it highlights the importance of examining the cause of small bowel obstruction in a surgically naïve abdomen, as exploration led to the discovery and curative treatment of a primary intestinal malignancy. It also underscores the nonspecific presentation that PFLs of the small intestine can have and the importance of understanding the different histopathology and immunohistochemical profiles of small bowel malignancies.

A 53-year-old male veteran with a history of heavy tobacco and alcohol use presented with abdominal pain, emesis, and no bowel movements for 2 days. He had no history of surgical procedures, malignancies, diverticulitis, inflammatory bowel disease, traveling abroad, parasitic infections, tuberculosis exposure, or hospital admissions for abdominal pain. He reported experiencing no flushing, diarrhea, or cardiac symptoms. His medical history included hypertension, depression, and osteoarthritis. His vital signs were within normal limits.

A physical examination revealed a distended abdomen with mild tenderness. He had no inguinal or ventral hernias. He also had no abnormal skin lesions. A rectal examination did not reveal any masses or blood. His laboratory values were normal. X-ray and computed tomography (CT) scan revealed dilated loops of proximal small bowel, mild wall thickening in a segment of the midileum, and narrowing of the distal small bowel suggestive of a partial small bowel obstruction (Figure 1). A 1-cm nonspecific omental nodule also was seen on the CT scan, but no enlarged lymph nodes or mesenteric calcifications were seen. There was no thickening of the terminal ileum.

The patient underwent an exploratory laparotomy, which revealed no adhesions. In the midileum there was an area of thickened bowel with some nodularity associated with the thickness, but no discrete mass. In the mesentery there were multiple hard, white, calcified nodules, with the majority clustered near the thickened ileal segment. There also was a 1-cm hard, peritoneal mass on the anterior abdominal wall. The segment of thickened ileum, the adjacent mesentery, and the peritoneal nodule were resected.

Pathologic examination of the resected tissue showed immunohistochemical stains that were positive for CD79a, CD10, and BCL-2 and negative for CD23, CD5, and CD3. Nineteen mesenteric lymph nodes were negative for malignancy. The postoperative staging positron emission tomography (PET) scan did not reveal any fluorodeoxyglucose avid masses anywhere else, and bone marrow biopsy showed no infiltration.

• What is your diagnosis?
• How would you treat this patient?
   

   

Diagnosis

Based on the pathologic examination of the resected tissue and immunohistochemical stains, this patient was diagnosed with malignant non-Hodgkin B-cell lymphoma, follicular type, grade 1. PET scan and bone marrow biopsy revealed no other lesions, making this a primary lymphoma of the small intestine. The resected tissue showed negative margins and negative lymph nodes, indicating the full extent of the patient’s tumor was removed. He then underwent nasogastric tube decompression and IV fluid resuscitation. Two days later, he had a large bowel movement, and his abdominal pain resolved. He was provided the treatment options of observation only, radiation therapy, or rituximab treatment. Based on the high risk of enteritis following radiation therapy, the patient elected for observation only, with a repeat scan in 6 months. He also was counseled on alcohol and tobacco cessation. At the 6-month oncology follow-up, the patient showed no evidence of disease recurrence.

Discussion

Small bowel obstruction accounts for about 350,000 hospitalizations annually in the US.¹ The incidence is equal in men and women and can present at any age.^2,3 Patients typically present nonspecifically, with intermittent, colicky abdominal pain, nausea, vomiting, and constipation.² A physical examination may reveal abdominal distention, rigidity, and hypoactive or absent bowel sounds.¹ The 2 most common etiologies of small bowel obstruction are adhesions from prior abdominal surgery (65%) and incarcerated inguinal hernias (10%).¹ However, in a patient presenting with a small bowel obstruction in a surgically naïve abdomen with no hernias, a more detailed history covering current malignancies, past hospital admissions for abdominal pains, pelvic inflammatory disease, diverticulitis, inflammatory bowel disease, and risks for parasite infection must be taken. The differential should include intraluminal causes, including small bowel malignancy, which accounts for 5% of small bowel obstructions,¹ as well as extraluminal causes, including adhesions from diverticulitis, Meckel diverticulum, Ladd bands, and undiagnosed prior appendicitis.

To provide a tissue diagnosis and definitive treatment, surgical exploration was needed for this patient. Exploratory laparotomy revealed an area of thickened ileum and calcified nodules in its mesentery. Pathologic examination of the resected tissue revealed large lymphoid nodules in a follicular pattern with coarse chromatin (Figure 2). Taken together with the immunohistochemical stains, this was consistent with malignant B-cell non-Hodgkin lymphoma, follicular type, grade 1.

Small bowel malignancy accounts for > 5% of all gastrointestinal tumors.⁴ Of these, small bowel neuroendocrine tumors are the most common, followed by adenocarcinomas, lymphomas, and stromal tumors.⁴ Primary follicular lymphoma (PFL) is a B-cell non-Hodgkin lymphoma, and comprises between 3.8% and 11% of gastrointestinal lymphomas, commonly in the duodenum and terminal ileum.⁵

PFL typically occurs in middle-aged females and can be difficult to diagnose, as most patients are asymptomatic or present with unspecified abdominal pain. Many are diagnosed incidentally when endoscopy biopsies are performed for other reasons.^4,5 Histologically, PFL is composed of a mixed population of small (centrocytes) and large (centroblasts) lymphoid cells, with higher proportions of centroblasts corresponding to a higher grade lymphoma.⁶ The classic immunophenotype of PFL shows coexpression of CD79a (or CD20), CD10, and BCL-2; however, in rare cases, low-grade PFL may stain negative for BCL-2 and have diminished staining for CD10 in interfollicular areas.⁷

PFL generally carries a favorable prognosis. Most patients achieving complete disease regression or stable disease following treatment and a low recurrence rate. Treatment can include surgical resection, radiation, rituximab therapy, chemotherapy, or observation.⁸ Patient also should be counseled in alcohol and tobacco cessation to reduce recurrence risk.

Other small bowel malignancies may present as small bowel obstructions as well. Neuroendocrine tumors and adenocarcinomas are both more common than small bowel lymphomas and can present as small bowel obstruction. However, neuroendocrine tumors are derived from serotonin-expressing enterochromaffin cells of the midgut and often present with classic carcinoid syndrome symptoms, including diarrhea, flushing, and right heart fibrosis, which the patient lacked.⁹ Immunohistology of small bowel adenocarcinoma often shows expression of MUC1 or MUC5AC with tumor markers CEA and CA 19-9.¹⁰

Primary intestinal melanoma, another small bowel malignancy, is extremely rare. More commonly, the etiology of intestinal melanoma is cutaneous melanoma that metastasizes to the gastrointestinal tract.¹¹ This patient had no skin lesions to suggest metastatic melanoma. With intestinal melanoma, immunohistochemical evaluation may show S-100, the most sensitive marker for melanoma, or HMB-45, MART-1/Melan-A, tyrosinase, and MITF.¹²

Conclusion

This case is notable because it highlights the importance of examining the cause of small bowel obstruction in a surgically naïve abdomen, as exploration led to the discovery and curative treatment of a primary intestinal malignancy. It also underscores the nonspecific presentation that PFLs of the small intestine can have and the importance of understanding the different histopathology and immunohistochemical profiles of small bowel malignancies.

Diabetic foot ulcers (DFUs) are devastating, common, and costly. This burden is borne disproportionately by veterans who have high prevalence of type 2 diabetes mellitus (T2DM) and other precipitating risk factors.¹ The mortality of veterans following a DFU is sobering, and ulceration is recognized as a significant marker of disease severity.

A 2017 study by Brennan and colleagues reported a 19% mortality rate within 1 year, and only 29% survive past 5 years.² DFUs are often complicated by peripheral arterial disease (PAD) and diabetic immune dysfunction, contributing to chronic wounds and infection.^3,4 About 60% of all foot ulcers become infected, and > 20% of patients with a diabetic foot infection require amputation.^5,6

A 2010 retrospective study reports that > 3,400 veterans have a diabetes-related lower extremity amputation annually, vastly surpassing the rate of amputation secondary to trauma in the Veterans Health Administration (VHA).^7,8 The inpatient costs for each amputation exceeded $60,000 in fiscal year 2010, and these amputation-related costs represent only 1 component of the total expense to the VHA attributable to diabetic foot complications.⁷ A recent systematic review by Chan and colleagues estimated mean annual costs in the year following a foot ulcer to be $44,200 to the public payer.⁹ This implies that direct expenditures for treatment of DFUs within the VHA exceeds $3 billion annually.

Diabetic Foot Ulcer Prevention

Given the dramatic impact of diabetic foot complications to the veteran and the US health care system, the VHA has long recognized the importance of preventive care for those at risk. In 2017 US Department of Veterans Affairs (VA) and Department of Defense issued a clinical practice guideline for the management of T2DM that recommended prophylactic foot care for early identification of any deformity or skin breakdown.¹⁰ The guidelines note that a “person who has had a foot ulcer is at lifelong risk of further ulceration,” reflecting the high rate of recurrence among all patients, including veterans. Multiple studies suggest that as many as 40% of patients experience recidivism in the first year after healing from a wound.^11-16

The VA is well equipped to deliver quality preventive care because of its innovative and long-standing PAVE (Prevention of Amputations for Veterans Everywhere) program.¹⁷ PAVE provides screening, education, appropriate footwear, and stratified care guidelines for veterans at risk for diabetes-related foot complications (Table 1). The practices encouraged by PAVE are evidence-based and synergistic with the objectives of the VA’s patient aligned care team (PACT) delivery approach.¹⁸ The granular data collected through PAVE are used to guide best practices and provide benchmarks for diabetic foot outcomes.

Unfortunately, despite PAVE guidelines requiring annual specialist foot care for at-risk veterans, a 2013 report by the VA Office of the Inspector General (OIG) found that one-third of all patients had no documentation of this minimal requirement of preventive foot care.¹⁹ Although the VA has worked to address this issue, the data hint at the missed opportunities for prevention of complications and the challenges of ensuring that a large at-risk veteran population has systematic and routine screening with access to specialist foot care.

Given the large proportion of veterans at high risk of chronic wound formation and the challenges of ensuring that this cohort receives good preventive foot care, expanding telemedicine has been suggested. Telemedicine solutions have the potential to reduce the impact of chronic wounds on overburdened clinic resources, schedules, and local and federal budgets.²⁰ Interestingly, the only preventive practice for the diabetic foot that has been proven effective through multiple randomized controlled trials and national and international clinical guidance documents is once-daily foot temperature monitoring.^21-26 Daily monitoring has the potential to reduce the burden of DFUs to veterans, improve veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications. Yet despite a recent national guidance document detailing its appropriate use in PAVE 3 veterans, it remains underutilized.²⁷

The purpose of this review is to: (1) discuss the evidence supporting once-daily remote temperature monitoring (RTM), a telemedicine approach critical to improving both veteran access to care and diabetic foot outcomes; (2) summarize a 2017 study that presented an advanced clinical understanding of RTM use among veterans; (3) provide previously unpublished data from this study comparing high-risk VA and non-VA cohorts, highlighting the opportunity for additional focus on foot ulcer prevention within the VA; and (4) report on recent VA utilization of a RTM technology based on this research, emphasizing lessons learned and best practices.

Remote Temperature Monitoring

The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot neuroarthropathy episodes. The patient and care team then act to resolve the cause of detected inflammation before clinical presentation (prevention) and begin treatment earlier than would otherwise be possible to avoid expensive complications, such as infection (early detection). Preventive therapies are low risk to the patient and inexpensive.

RTM is recommended by multiple clinical practice guidelines, including those of the International Working Group on the Diabetic Foot, the American College of Foot and Ankle Surgeons, and the Wound Healing Society.^24-26 Its use is supported by evidence from 3 National Institutes of Health-funded and well-designed randomized controlled trials, 1 of which was additionally supported by a VA Health Services Research and Development Service Merit Award.^21-23,28 Conducted between 2004 and 2007, these studies demonstrated the potential to reduce foot ulcer incidence by as much as 85% using a dermal thermometer to identify inflammation and prompt decreased ambulation. Investigators established a clinical monitoring protocol comparing the temperatures between 6 matched locations on the left and right feet. Persistent differences in contralateral temperatures exceeding 2.2°C (4.0°F) were used as a marker for elevated risk and to initiate preventive care. Based on the encouraging results from these studies, a 2017 effectiveness review prepared for the Agency for Healthcare Research and Quality concluded that “home monitoring of foot skin temperature is effective for reducing foot ulcer incidence and recurrence.”²⁹

Accuracy of RTM

A 2017 longitudinal study (NCT02647346) has provided novel data to advance understanding of RTM for the prediction and prevention of DFUs.³⁰ This study was the first to systematically analyze the accuracy of RTM over different monitoring thresholds. The results enable practitioners to deliver risk-stratified preventive care. Policy makers can use the data from this study to weigh the cost and benefits of RTM for population health.

The multicenter trials had 129 participants from 4 VA health care systems: VA Long Beach Healthcare System in California, Miami VA Healthcare System in Florida, Phoenix VA Healthcare System in Arizona, and VA West Los Angeles Healthcare System in California. Each participant was followed for 34 weeks under standard preventive foot care and was instructed to step on a telemedicine SmartMat (Podimetrics, Inc) RTM mat for 20 seconds daily. Participants and investigators were blinded to the temperature data so that the accuracy of temperature monitoring could be assessed. All participants had a history of T2DM and healed DFU. Principal exclusion criteria included unhealed plantar wound, history of proximal lower extremity amputation (ie, above ankle), active Charcot foot disease, and comorbidities that could potentially inhibit an inflammatory response, such as end-stage renal disease, active malignancy, and immunosuppressive diseases.

The investigators reported that RTM with the study mat detected 97% of nonacute plantar DFUs using the most commonly studied threshold (sustained 2.2°C temperature difference). The lead time averaged 37 days before clinical identification of the wound under standard care. Although the false-positive rate of 57% was high, corresponding to approximately 3.0 notifications per patient per year on average in the research setting, it is important to note that this study only considered the prediction of plantar DFUs. Thus, detection of foot inflammation secondary to other conditions, such as preulcerative lesion, dorsal wound, Charcot neuroarthropathy, or foot infection, were reported as a false positive per the study’s definitions. Further, Crisologo and Lavery noted in a translational medicine summary of this research, because the intervention is noninvasive and minimally impactful to the patient and the health care system, “the potential to arrest re-ulceration is worth the perceived inconvenience to the patient.”³¹

Secondary outcomes related to adherence and ease of use were encouraging. Eighty-eight percent of participants reported that the mat was “very easy to use,” the highest possible score, and 98% were able to set up the mat for home use without difficulty. At the end of the 34-week study, more than 74% of participants remained engaged in routine use of the mat under a per-protocol assessment of adherence. These results are especially impressive given the documented poor adherence of at-risk patients to routine use of therapeutic footwear, which has been reported to be as low as 15%.³²

New Research

The data collected during this study has led to new research and advancements in RTM. A recent publication by Gordon and colleagues investigated whether RTM is less accurate in cohorts with perceived challenges.³³ They include patients with recently healed wounds and those with a history of partial foot amputation. There was no difference in the accuracy or lead time for either cohort relative to the entire cohort, suggesting that RTM is appropriate for monitoring patients with recently healed DFUs or partial foot amputations.

In another recent study, the data were used to derive a novel approach to monitor a single at-risk foot.³⁴ The practice of RTM has traditionally required comparing temperatures between contralaterally matched plantar locations on the feet, thus limiting its use in patients with a history of major lower extremity amputation and patients being treated for a wound, which may be bandaged or in an off-loading cast or boot. Because the risk factors for DFUs exist in both limbs, these patients are at high risk for developing complications to the contralateral foot and may benefit from preventive once-daily foot temperature monitoring. The investigators empirically derived a novel monitoring approach for patients without a contralateral control. This approach was found to predict 91% of impending plantar DFUs on average 41 days before clinical presentation with a false positive rate of 54%.

Additional Focus on Prevention

Table 2 shows previously unpublished data from a subgroup analysis between veteran and nonveteran participants in the study.²⁵ These descriptive statistics reinforce some widely held assumptions regarding the high-risk veteran population and challenge others. For example, compared with the nonveteran participants, the veteran cohort unsurprisingly had a larger ratio of male participants (P < .01), had a higher rate of cigarette use (P < .01), and was more likely to live alone (although not at a statistically significant level). Veterans in the study had body mass index, rates of alcohol use, frequency of exercise, and glucose control comparable to that of nonveterans.

The potential impact of the PAVE program is clear in several of these comparisons. Although as few as 15% of patients use therapeutic shoes routinely, PAVE ensures that the majority of veterans receive them. Nearly 95% of veterans have therapeutic shoes compared with about 80% of nonveteran participants (P < .05). Veterans also had higher ankle-brachial index results (P < .05), although on average both cohorts were within normal clinical parameters. Veterans had a significantly longer duration since healing from the most recent wound, and fewer veteran participants had a wound that healed in the 3 months prior to the study. Despite this, during the study veterans had annualized DFU incidence equal to that of nonveterans. Furthermore, veterans also had significantly higher rates of amputation prior to participation. That these critical outcomes for veterans are no better than those observed in other care environments despite PAVE suggests that approaches recommended via PAVE alone are insufficient to significantly arrest DFU recurrence, and even more focus on prevention in the VA may be warranted.

From Research to Practice

Since the publication of the 2017 study, the VHA has been at the vanguard of translating the evidence and research underlying RTM into clinical practice. A clinical guidance document governing appropriate use of RTM with the study mat was recently published by the VA Prosthetic and Sensory Aids Service in collaboration with the National Podiatry Program office.²⁷ This guidance document recommends once-daily RTM for at-risk veterans designated PAVE level 3. It defines roles and responsibilities required for the successful implementation of a RTM program with the study device. The document additionally presents various clinical monitoring protocols for veterans, although the protocol and thresholds used are at the discretion of the prescribing clinician and should reflect the risk profile of the veteran in question.

A staged response to inflammation has proven popular, whereby an initial high-sensitivity threshold is chosen for monitoring. The initial response is telephone outreach by a designee supplied by the clinic or device manufacturer, typically a trained registered nurse, to the veteran to collect subjective history and instruct off-loading and reduced ambulation, with a target of 50% baseline reduction in step count. Should the inflammation persist despite off-loading, an examination may be necessary to identify and resolve its cause. For recalcitrant inflammation, more targeted pressure off-loading of the affected area may be accomplished with custom orthotics, accommodative insoles, removable cast walkers, and total contact casting. After 2 to 4 weeks without signs of inflammation, the cause is deemed to have been resolved and lowered the acute risk for developing further diabetic foot complications.

More than 600 veterans have been monitored for > 1,000 patient-years—13 VA medical centers are practicing RTM with the study mat as of this writing. The monitoring program has been integrated into many veteran daily routines as evidenced by > 70% retaining full engagement after having been monitored for > 1 year. The total number of alerts/patient-years across these veterans has been 1.4, significantly lower than the 3.0 alerts/patient-year observed in the study. This is potentially due to successful interventions in response to detected inflammation, resolving inflammation, and avoiding unnecessary alerts occurring in the research setting, which did not employ interventions that resolved inflammation episodes. In the past 6 months, 68% of all inflammation detected resolved via off-loading alone without requiring further clinical intervention. In the cases that required an examination, 76% of patients reported clinically meaningful preventive care (eg, preulcerative callus was debrided, a subungual hemorrhage was treated, a foot ulcer was identified).

Organizational Best Practices

Several best practices have been cultivated related to initiating a RTM program at a new site, for promoting the success of a RTM program, and provisioning excellent preventive care to support the RTM program. Although we advise adhering to the recommendations in the VA guidance document,²⁷ the authors have observed several additional organizational best practices that are not explicitly addressed.

Partnering with PACT. Collaboration between PAVE and PACT has the potential not only to improve outcomes for patients at risk for diabetic foot complications, but also can help identify appropriate high-risk veteran candidates for preventive care with RTM who may not be followed for routine care from a specialty provider, such as a podiatrist, as highlighted by the 2013 OIG report.

Prescreening eligible patients. Several programs have used PAVE data or appointment schedules to identify and target high-risk veterans proactively. This approach has several benefits. It simplifies clinical coordination and streamlines workflow for patient identification and onboarding. It also allows those veterans at highest risk to receive needed and recommended preventive care at their next scheduled appointment. Finally, if PAVE data are used to identify eligible patients, it has the added benefit of ensuring a baseline level of telemedicine preventive foot care for veterans who have become lost to follow-up and have not been seen recently for a routine foot examination.

Implementing foot monitoring during wound treatment. Recent research has expanded the reach of once-daily RTM with the mat to patients being treated for a wound to only 1 foot. This practice has 2 benefits: The patient is able to establish a preventive routine before healing, an important advantage because research strongly suggests that recurrence is most likely in the first months after healing. Second, 48% of patients with a history of DFUs will develop new wounds to the contralateral foot because risk factors, such as neuropathy and peripheral arterial disease, exist in both limbs.³⁵ Furthermore, ongoing treatment for a wound to 1 foot may result in gait deviation and elevated pressure to the sound foot, additionally predisposing the veteran to complications, resulting in a high rate of wounds occurring to the unwounded foot during treatment (0.2 DFU/DFU-year).³⁴ Thus, there is potential benefit in monitoring the sound foot while undergoing treatment for a wound; further, the patient will have immediate access to the device for prevention of recurrence once the wound has resolved.

Utilizing foot monitoring as an extension of telemedicine. Many VA facilities have large geographic catchment areas, making routine follow-up difficult for veterans living in rural areas. RTM serves as an extension of the patient’s daily self-examination and the clinician’s ability to monitor patients with objective information daily. The veterans using the system become more invested and feel as though they are taking an active role in their health care.

Investing in ongoing medical education. Multidisciplinary education sessions reviewing supporting clinical data and resultant clinical practice guidelines raise awareness for those providers and trainees unaware of preventive best practices for the diabetic foot, including those related to foot RTM. These sessions also are helpful for those familiar with foot temperature monitoring or who are responsible for administration of an ongoing program to remain current with contemporary best practices and to discuss improvements for patient care. Familiarity also can help address clinical inertia when benefits and evidence are clearly communicated with health care providers (HCPs).

Clinical Best Practices

Treating preulcerative lesions urgently and aggressively. Callus and other preulcerative lesions often cause progressive tissue damage and poor outcomes. When identified, these lesions should be promptly treated to ensure best outcomes.²⁴

Recognizing the limits of patient self-examinations. Comorbidities such as visual impairment and reduced joint mobility often preclude patients from completing rigorous self-examinations of the foot, which is especially critical while collecting subjective history from the patient during triage of inflammation. A caregiver or spouse can help inspect the foot during outreach and provide additional context.³⁶

Interpreting a benign foot on examination. Because RTM has been demonstrated to detect inflammation preceding a foot ulcer as many as 5 weeks before presentation to the clinic, some veterans may have few signs or symptoms of acute risk during examination. Often, the damage is to subcutaneous tissue resulting from repetitive microtrauma. Research suggests that clinical examination in these cases is often unreliable for identifying the earliest signs of risk, such as palpation to identify subtle temperature changes secondary to inflammation.³⁷ If a patient has refractory inflammation requiring examination and presents with an otherwise unremarkable foot, it is an opportunity to evaluate whether the patient’s shoewear remains appropriate or has worn out, to communicate the veteran’s ongoing elevated risk, and to educate on the importance of diligence in daily foot self-examinations, daily use of the foot temperature monitoring, and continued off-loading until the inflammation resolves.

Communicating the distinction between healing and remission. Although healing is the goal of wound care, patients should be educated that the underlying disease remains after epithelialization. In some cases, tissue deep to the skin has not completed remodeling, and the patient is at acute risk of recurrence. Remission is a powerful metaphor that better describes the patient’s ongoing risk to encourage continued healthy routines and diligent self-care.³⁸Considering the entirety of both feet for recurrence. Critical risk factors for diabetic foot complications, such as peripheral neuropathy and PAD, exist in both limbs, and patients with a history of wounds often develop new complications to different ipsilateral locations, or in as many as 48% of cases, to the contralateral foot.³⁵ For best outcomes, detected inflammation should be treated aggressively independent of whether the location coincides with an area of previous concern.

Encouraging adherence, routine, and empowerment. Advanced diabetes mellitus and neuropathy may impact a patient’s executive function, and multiple studies have reported that patients at risk for inflammatory foot diseases exhibit fatalism toward their foot care and outcomes.^39-41 Consistent education, encouragement, empowerment, and establishment of positive routines are needed to ensure high adherence with all preventive care regimens, including RTM.

Case Presentations

The following case series illustrates many of these clinical best practices and characterizes the potential benefits of RTM to veterans within the VA.

Case 1: Prevention After Healing

A veteran underwent a Chopart amputation and was recommended to use the mat after healing was perceived. Immediately on use of the study mat, the patient was found to have inflammation to the surgical incision (Figure 1). Clinical staff was alerted to the findings, and the patient was instructed to limit further walking and continue off-loading in his removable cast walker, per protocol. The inflammation of the operative foot quickly reduced, and the patient continued healing successfully, potentially avoiding incisional dehiscence and possible postoperative infection.

This case illustrates that patients’ wounds or surgical incisions may not be completely healed on epithelialization. In the immediate phase after closure, HCPs should consider additional protection to avoid complications. This case demonstrates that RTM can provide objective data to help guide care in that critical period.

Case 2: Identifying Preulcerative Lesions

An 88-year-old veteran had a chronic callus under the second metatarsal head. In addition to routine foot care and therapeutic shoes, he was followed with once-daily RTM. Inflammation was noted, and the veteran was seen in the podiatry clinic where debridement of the callus was performed. The difference in temperatures between feet detected by thermography prior to the clinic visits rapidly resolved after callus debridement, indicating that the underlying inflammation had subsided. RTM was used by the clinical staff to determine the appropriate time interval between clinic visits to avoid callus breakdown and subsequent ulceration.

Case 3: Extending the Clinic Into the Home

An 80-year-old veteran with T2DM and neuropathy was deemed a high-risk patient due to recurrent ulcerations to the left great toe. He was issued a RTM mat and was adherent with routine use. After nearly a year without hot-spot development, inflammation was noted (Figure 2).

Unfortunately, the patient had missed several routine foot care visits and likely that was the reason for the noted inflammation. The patient was called and became reengaged in regular visits for routine foot care. On debridement of his callus, a superficial, noninfected ulceration was discovered. Had remote monitoring not detected the inflammation and impending ulceration, the patient likely would not have been seen in the regular clinic and may have developed a wound infection, potentially resulting in a worse and more costly outcome.

Paradigm Shift to Prevention

Given the exceedingly high burden of diabetic foot complications in the VA, a paradigm shift is needed among HCPs from a culture of treatment to one of prevention. Bus and colleagues reported that in Europe, for every euro spent on ulcer prevention, 10 are spent on ulcer healing, and for every randomized clinical trial conducted on prevention, 10 are conducted on treatment.^42-44 Hicks and colleagues showed that the cost of curative care for DFUs is 5 to 30 times greater than the cost of preventive care.⁴⁵ For RTM in high-risk cohorts (ie, PAVE level 3), the number-needed-to-treat for DFU prevention may be as low as 6, assuming that a 70% reduction in incidence is possible, consistent with previous research. In the year following a DFU, costs exceed $44,000.⁹ Thus, it seems natural that future direction in diabetic foot care should emphasize prevention strategies.

Foot ulcers that become infected often lead to hospitalization and result in an increased burden to an already overburdened VA health care system. Research suggests that about two-thirds of all diabetic foot costs are attributable to inpatient management.⁴⁶ The impact of diabetic foot complications on hospital resource utilization is staggering. A 2017 study by Skrepnik analyzed the risk of hospitalization for various diseases.⁴⁷ The investigators found that the inpatient admission odds ratio (OR) for congestive heart failure was 2.6, surpassed only by DFUs (OR, 3.4) and diabetic foot infection (OR, 6.7). A 2019 point-prevalence study found that > 10% of hospital admissions have a foot-related condition as the primary or secondary reason, and the majority of these are due to foot diseases, such as ulcers, infections, and Charcot neuroarthropathy.⁴⁸

It is therefore incumbent on VA HCPs to avert wound recurrence in the interest of avoiding veteran hospitalizations and for administrators to encourage and incentivize best practices for managing the diabetic foot, with an emphasis on prevention therapies. In evaluating the financial impact of prevention with foot RTM, administrators should consider that the cost benefit is likely to be realized across the medical center, with budgets related to inpatient management likely to receive the largest returns.

Prevention has the potential to rein in costs as well as reduce strain on the hospital and clinic by preventing outcomes that require frequent visits for treatment or hospitalization. Wound treatment is very burdensome to the clinic; patients require frequent (in many cases, weekly) examinations, and chronic wounds often require hospitalization, necessitating rounding and additional coordination in care. Thus, preventing wounds or reducing their severity at presentation substantially reduces burden on the clinic, even after accounting for the modest clinical resources needed to administer preventative care. For example, a brief examination may be necessary if the inflammation detected by the study mat is secondary to a callus that must be debrided. However, if the patient was not seen until the callus had progressed to a wound, weekly follow-up and substantial clinical and budgetary resources may be required to heal the wound. Preventive care allows for substantially better patient outcomes, and the minimal time invested prevents the clinical burden of extensive wound treatment.

The success of preventive efforts relies on multidisciplinary management of this high-risk patient cohort. Often, it is the responsibility of the primary care provider to follow diabetic foot clinical reminders and appropriately refer to specialty care. Successful, open communication between PACT, PAVE, and the Podiatry Service has been shown to reduce poor outcomes, including lower extremity amputations. Traditionally, the model of preventive care has included podiatrist-driven interventions, including integrated routine foot care and comprehensive diabetic foot education. Collaboration between routine evaluation and prompt referral of at-risk patients for specialist foot care, therapeutic footwear recommendations, daily self-foot examinations, and in-home temperature monitoring are critically effective when performed consistently.

When trying to translate research science to effective clinical practice for preventing lower extremity complication, there are several important concepts. First, given the frequency of examination for patients being treated for a wound, provision of good preventive care, such as RTM, can reduce overall burden to resource-constrained clinics and improve access for patients needing to be seen. Additionally, preventive efforts extend clinical practice into the home and may reduce the need for in-clinic examinations and routine follow-up visits. Finally, there may be a sense of trust established between the clinician and patient with a positive record of adherence with preventive practices. This may translate into more productive communication and less frequent routine visits to better accommodate urgent visits and ensure podiatric care is accessible to veterans.

Conclusions

There is a significant opportunity to shift diabetic foot care from treatment to prevention, improving veteran outcomes and reducing resource utilization. RTM is an evidence-based and recommended but underused telemedicine solution that can catalyze this needed paradigm shift. The VA has been at the forefront of preventive foot care through the PAVE program and more recently through research and clinical application of RTM for veterans. However, as the data presented suggest, more can be done to improve veteran outcomes. More widespread adoption of evidence-based preventive technologies for the diabetic foot, such as RTM, has the potential to dramatically improve the quality of and access to care and reduce costs and burden on resource-constrained clinics.

Diabetic foot ulcers (DFUs) are devastating, common, and costly. This burden is borne disproportionately by veterans who have high prevalence of type 2 diabetes mellitus (T2DM) and other precipitating risk factors.¹ The mortality of veterans following a DFU is sobering, and ulceration is recognized as a significant marker of disease severity.

A 2017 study by Brennan and colleagues reported a 19% mortality rate within 1 year, and only 29% survive past 5 years.² DFUs are often complicated by peripheral arterial disease (PAD) and diabetic immune dysfunction, contributing to chronic wounds and infection.^3,4 About 60% of all foot ulcers become infected, and > 20% of patients with a diabetic foot infection require amputation.^5,6

A 2010 retrospective study reports that > 3,400 veterans have a diabetes-related lower extremity amputation annually, vastly surpassing the rate of amputation secondary to trauma in the Veterans Health Administration (VHA).^7,8 The inpatient costs for each amputation exceeded $60,000 in fiscal year 2010, and these amputation-related costs represent only 1 component of the total expense to the VHA attributable to diabetic foot complications.⁷ A recent systematic review by Chan and colleagues estimated mean annual costs in the year following a foot ulcer to be $44,200 to the public payer.⁹ This implies that direct expenditures for treatment of DFUs within the VHA exceeds $3 billion annually.

Diabetic Foot Ulcer Prevention

Given the dramatic impact of diabetic foot complications to the veteran and the US health care system, the VHA has long recognized the importance of preventive care for those at risk. In 2017 US Department of Veterans Affairs (VA) and Department of Defense issued a clinical practice guideline for the management of T2DM that recommended prophylactic foot care for early identification of any deformity or skin breakdown.¹⁰ The guidelines note that a “person who has had a foot ulcer is at lifelong risk of further ulceration,” reflecting the high rate of recurrence among all patients, including veterans. Multiple studies suggest that as many as 40% of patients experience recidivism in the first year after healing from a wound.^11-16

The VA is well equipped to deliver quality preventive care because of its innovative and long-standing PAVE (Prevention of Amputations for Veterans Everywhere) program.¹⁷ PAVE provides screening, education, appropriate footwear, and stratified care guidelines for veterans at risk for diabetes-related foot complications (Table 1). The practices encouraged by PAVE are evidence-based and synergistic with the objectives of the VA’s patient aligned care team (PACT) delivery approach.¹⁸ The granular data collected through PAVE are used to guide best practices and provide benchmarks for diabetic foot outcomes.

Unfortunately, despite PAVE guidelines requiring annual specialist foot care for at-risk veterans, a 2013 report by the VA Office of the Inspector General (OIG) found that one-third of all patients had no documentation of this minimal requirement of preventive foot care.¹⁹ Although the VA has worked to address this issue, the data hint at the missed opportunities for prevention of complications and the challenges of ensuring that a large at-risk veteran population has systematic and routine screening with access to specialist foot care.

Given the large proportion of veterans at high risk of chronic wound formation and the challenges of ensuring that this cohort receives good preventive foot care, expanding telemedicine has been suggested. Telemedicine solutions have the potential to reduce the impact of chronic wounds on overburdened clinic resources, schedules, and local and federal budgets.²⁰ Interestingly, the only preventive practice for the diabetic foot that has been proven effective through multiple randomized controlled trials and national and international clinical guidance documents is once-daily foot temperature monitoring.^21-26 Daily monitoring has the potential to reduce the burden of DFUs to veterans, improve veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications. Yet despite a recent national guidance document detailing its appropriate use in PAVE 3 veterans, it remains underutilized.²⁷

The purpose of this review is to: (1) discuss the evidence supporting once-daily remote temperature monitoring (RTM), a telemedicine approach critical to improving both veteran access to care and diabetic foot outcomes; (2) summarize a 2017 study that presented an advanced clinical understanding of RTM use among veterans; (3) provide previously unpublished data from this study comparing high-risk VA and non-VA cohorts, highlighting the opportunity for additional focus on foot ulcer prevention within the VA; and (4) report on recent VA utilization of a RTM technology based on this research, emphasizing lessons learned and best practices.

Remote Temperature Monitoring

The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot neuroarthropathy episodes. The patient and care team then act to resolve the cause of detected inflammation before clinical presentation (prevention) and begin treatment earlier than would otherwise be possible to avoid expensive complications, such as infection (early detection). Preventive therapies are low risk to the patient and inexpensive.

RTM is recommended by multiple clinical practice guidelines, including those of the International Working Group on the Diabetic Foot, the American College of Foot and Ankle Surgeons, and the Wound Healing Society.^24-26 Its use is supported by evidence from 3 National Institutes of Health-funded and well-designed randomized controlled trials, 1 of which was additionally supported by a VA Health Services Research and Development Service Merit Award.^21-23,28 Conducted between 2004 and 2007, these studies demonstrated the potential to reduce foot ulcer incidence by as much as 85% using a dermal thermometer to identify inflammation and prompt decreased ambulation. Investigators established a clinical monitoring protocol comparing the temperatures between 6 matched locations on the left and right feet. Persistent differences in contralateral temperatures exceeding 2.2°C (4.0°F) were used as a marker for elevated risk and to initiate preventive care. Based on the encouraging results from these studies, a 2017 effectiveness review prepared for the Agency for Healthcare Research and Quality concluded that “home monitoring of foot skin temperature is effective for reducing foot ulcer incidence and recurrence.”²⁹

Accuracy of RTM

A 2017 longitudinal study (NCT02647346) has provided novel data to advance understanding of RTM for the prediction and prevention of DFUs.³⁰ This study was the first to systematically analyze the accuracy of RTM over different monitoring thresholds. The results enable practitioners to deliver risk-stratified preventive care. Policy makers can use the data from this study to weigh the cost and benefits of RTM for population health.

The multicenter trials had 129 participants from 4 VA health care systems: VA Long Beach Healthcare System in California, Miami VA Healthcare System in Florida, Phoenix VA Healthcare System in Arizona, and VA West Los Angeles Healthcare System in California. Each participant was followed for 34 weeks under standard preventive foot care and was instructed to step on a telemedicine SmartMat (Podimetrics, Inc) RTM mat for 20 seconds daily. Participants and investigators were blinded to the temperature data so that the accuracy of temperature monitoring could be assessed. All participants had a history of T2DM and healed DFU. Principal exclusion criteria included unhealed plantar wound, history of proximal lower extremity amputation (ie, above ankle), active Charcot foot disease, and comorbidities that could potentially inhibit an inflammatory response, such as end-stage renal disease, active malignancy, and immunosuppressive diseases.

The investigators reported that RTM with the study mat detected 97% of nonacute plantar DFUs using the most commonly studied threshold (sustained 2.2°C temperature difference). The lead time averaged 37 days before clinical identification of the wound under standard care. Although the false-positive rate of 57% was high, corresponding to approximately 3.0 notifications per patient per year on average in the research setting, it is important to note that this study only considered the prediction of plantar DFUs. Thus, detection of foot inflammation secondary to other conditions, such as preulcerative lesion, dorsal wound, Charcot neuroarthropathy, or foot infection, were reported as a false positive per the study’s definitions. Further, Crisologo and Lavery noted in a translational medicine summary of this research, because the intervention is noninvasive and minimally impactful to the patient and the health care system, “the potential to arrest re-ulceration is worth the perceived inconvenience to the patient.”³¹

Secondary outcomes related to adherence and ease of use were encouraging. Eighty-eight percent of participants reported that the mat was “very easy to use,” the highest possible score, and 98% were able to set up the mat for home use without difficulty. At the end of the 34-week study, more than 74% of participants remained engaged in routine use of the mat under a per-protocol assessment of adherence. These results are especially impressive given the documented poor adherence of at-risk patients to routine use of therapeutic footwear, which has been reported to be as low as 15%.³²

New Research

The data collected during this study has led to new research and advancements in RTM. A recent publication by Gordon and colleagues investigated whether RTM is less accurate in cohorts with perceived challenges.³³ They include patients with recently healed wounds and those with a history of partial foot amputation. There was no difference in the accuracy or lead time for either cohort relative to the entire cohort, suggesting that RTM is appropriate for monitoring patients with recently healed DFUs or partial foot amputations.

In another recent study, the data were used to derive a novel approach to monitor a single at-risk foot.³⁴ The practice of RTM has traditionally required comparing temperatures between contralaterally matched plantar locations on the feet, thus limiting its use in patients with a history of major lower extremity amputation and patients being treated for a wound, which may be bandaged or in an off-loading cast or boot. Because the risk factors for DFUs exist in both limbs, these patients are at high risk for developing complications to the contralateral foot and may benefit from preventive once-daily foot temperature monitoring. The investigators empirically derived a novel monitoring approach for patients without a contralateral control. This approach was found to predict 91% of impending plantar DFUs on average 41 days before clinical presentation with a false positive rate of 54%.

Additional Focus on Prevention

Table 2 shows previously unpublished data from a subgroup analysis between veteran and nonveteran participants in the study.²⁵ These descriptive statistics reinforce some widely held assumptions regarding the high-risk veteran population and challenge others. For example, compared with the nonveteran participants, the veteran cohort unsurprisingly had a larger ratio of male participants (P < .01), had a higher rate of cigarette use (P < .01), and was more likely to live alone (although not at a statistically significant level). Veterans in the study had body mass index, rates of alcohol use, frequency of exercise, and glucose control comparable to that of nonveterans.

The potential impact of the PAVE program is clear in several of these comparisons. Although as few as 15% of patients use therapeutic shoes routinely, PAVE ensures that the majority of veterans receive them. Nearly 95% of veterans have therapeutic shoes compared with about 80% of nonveteran participants (P < .05). Veterans also had higher ankle-brachial index results (P < .05), although on average both cohorts were within normal clinical parameters. Veterans had a significantly longer duration since healing from the most recent wound, and fewer veteran participants had a wound that healed in the 3 months prior to the study. Despite this, during the study veterans had annualized DFU incidence equal to that of nonveterans. Furthermore, veterans also had significantly higher rates of amputation prior to participation. That these critical outcomes for veterans are no better than those observed in other care environments despite PAVE suggests that approaches recommended via PAVE alone are insufficient to significantly arrest DFU recurrence, and even more focus on prevention in the VA may be warranted.

From Research to Practice

Since the publication of the 2017 study, the VHA has been at the vanguard of translating the evidence and research underlying RTM into clinical practice. A clinical guidance document governing appropriate use of RTM with the study mat was recently published by the VA Prosthetic and Sensory Aids Service in collaboration with the National Podiatry Program office.²⁷ This guidance document recommends once-daily RTM for at-risk veterans designated PAVE level 3. It defines roles and responsibilities required for the successful implementation of a RTM program with the study device. The document additionally presents various clinical monitoring protocols for veterans, although the protocol and thresholds used are at the discretion of the prescribing clinician and should reflect the risk profile of the veteran in question.

A staged response to inflammation has proven popular, whereby an initial high-sensitivity threshold is chosen for monitoring. The initial response is telephone outreach by a designee supplied by the clinic or device manufacturer, typically a trained registered nurse, to the veteran to collect subjective history and instruct off-loading and reduced ambulation, with a target of 50% baseline reduction in step count. Should the inflammation persist despite off-loading, an examination may be necessary to identify and resolve its cause. For recalcitrant inflammation, more targeted pressure off-loading of the affected area may be accomplished with custom orthotics, accommodative insoles, removable cast walkers, and total contact casting. After 2 to 4 weeks without signs of inflammation, the cause is deemed to have been resolved and lowered the acute risk for developing further diabetic foot complications.

More than 600 veterans have been monitored for > 1,000 patient-years—13 VA medical centers are practicing RTM with the study mat as of this writing. The monitoring program has been integrated into many veteran daily routines as evidenced by > 70% retaining full engagement after having been monitored for > 1 year. The total number of alerts/patient-years across these veterans has been 1.4, significantly lower than the 3.0 alerts/patient-year observed in the study. This is potentially due to successful interventions in response to detected inflammation, resolving inflammation, and avoiding unnecessary alerts occurring in the research setting, which did not employ interventions that resolved inflammation episodes. In the past 6 months, 68% of all inflammation detected resolved via off-loading alone without requiring further clinical intervention. In the cases that required an examination, 76% of patients reported clinically meaningful preventive care (eg, preulcerative callus was debrided, a subungual hemorrhage was treated, a foot ulcer was identified).

Organizational Best Practices

Several best practices have been cultivated related to initiating a RTM program at a new site, for promoting the success of a RTM program, and provisioning excellent preventive care to support the RTM program. Although we advise adhering to the recommendations in the VA guidance document,²⁷ the authors have observed several additional organizational best practices that are not explicitly addressed.

Partnering with PACT. Collaboration between PAVE and PACT has the potential not only to improve outcomes for patients at risk for diabetic foot complications, but also can help identify appropriate high-risk veteran candidates for preventive care with RTM who may not be followed for routine care from a specialty provider, such as a podiatrist, as highlighted by the 2013 OIG report.

Prescreening eligible patients. Several programs have used PAVE data or appointment schedules to identify and target high-risk veterans proactively. This approach has several benefits. It simplifies clinical coordination and streamlines workflow for patient identification and onboarding. It also allows those veterans at highest risk to receive needed and recommended preventive care at their next scheduled appointment. Finally, if PAVE data are used to identify eligible patients, it has the added benefit of ensuring a baseline level of telemedicine preventive foot care for veterans who have become lost to follow-up and have not been seen recently for a routine foot examination.

Implementing foot monitoring during wound treatment. Recent research has expanded the reach of once-daily RTM with the mat to patients being treated for a wound to only 1 foot. This practice has 2 benefits: The patient is able to establish a preventive routine before healing, an important advantage because research strongly suggests that recurrence is most likely in the first months after healing. Second, 48% of patients with a history of DFUs will develop new wounds to the contralateral foot because risk factors, such as neuropathy and peripheral arterial disease, exist in both limbs.³⁵ Furthermore, ongoing treatment for a wound to 1 foot may result in gait deviation and elevated pressure to the sound foot, additionally predisposing the veteran to complications, resulting in a high rate of wounds occurring to the unwounded foot during treatment (0.2 DFU/DFU-year).³⁴ Thus, there is potential benefit in monitoring the sound foot while undergoing treatment for a wound; further, the patient will have immediate access to the device for prevention of recurrence once the wound has resolved.

Utilizing foot monitoring as an extension of telemedicine. Many VA facilities have large geographic catchment areas, making routine follow-up difficult for veterans living in rural areas. RTM serves as an extension of the patient’s daily self-examination and the clinician’s ability to monitor patients with objective information daily. The veterans using the system become more invested and feel as though they are taking an active role in their health care.

Investing in ongoing medical education. Multidisciplinary education sessions reviewing supporting clinical data and resultant clinical practice guidelines raise awareness for those providers and trainees unaware of preventive best practices for the diabetic foot, including those related to foot RTM. These sessions also are helpful for those familiar with foot temperature monitoring or who are responsible for administration of an ongoing program to remain current with contemporary best practices and to discuss improvements for patient care. Familiarity also can help address clinical inertia when benefits and evidence are clearly communicated with health care providers (HCPs).

Clinical Best Practices

Treating preulcerative lesions urgently and aggressively. Callus and other preulcerative lesions often cause progressive tissue damage and poor outcomes. When identified, these lesions should be promptly treated to ensure best outcomes.²⁴

Recognizing the limits of patient self-examinations. Comorbidities such as visual impairment and reduced joint mobility often preclude patients from completing rigorous self-examinations of the foot, which is especially critical while collecting subjective history from the patient during triage of inflammation. A caregiver or spouse can help inspect the foot during outreach and provide additional context.³⁶

Interpreting a benign foot on examination. Because RTM has been demonstrated to detect inflammation preceding a foot ulcer as many as 5 weeks before presentation to the clinic, some veterans may have few signs or symptoms of acute risk during examination. Often, the damage is to subcutaneous tissue resulting from repetitive microtrauma. Research suggests that clinical examination in these cases is often unreliable for identifying the earliest signs of risk, such as palpation to identify subtle temperature changes secondary to inflammation.³⁷ If a patient has refractory inflammation requiring examination and presents with an otherwise unremarkable foot, it is an opportunity to evaluate whether the patient’s shoewear remains appropriate or has worn out, to communicate the veteran’s ongoing elevated risk, and to educate on the importance of diligence in daily foot self-examinations, daily use of the foot temperature monitoring, and continued off-loading until the inflammation resolves.

Communicating the distinction between healing and remission. Although healing is the goal of wound care, patients should be educated that the underlying disease remains after epithelialization. In some cases, tissue deep to the skin has not completed remodeling, and the patient is at acute risk of recurrence. Remission is a powerful metaphor that better describes the patient’s ongoing risk to encourage continued healthy routines and diligent self-care.³⁸Considering the entirety of both feet for recurrence. Critical risk factors for diabetic foot complications, such as peripheral neuropathy and PAD, exist in both limbs, and patients with a history of wounds often develop new complications to different ipsilateral locations, or in as many as 48% of cases, to the contralateral foot.³⁵ For best outcomes, detected inflammation should be treated aggressively independent of whether the location coincides with an area of previous concern.

Encouraging adherence, routine, and empowerment. Advanced diabetes mellitus and neuropathy may impact a patient’s executive function, and multiple studies have reported that patients at risk for inflammatory foot diseases exhibit fatalism toward their foot care and outcomes.^39-41 Consistent education, encouragement, empowerment, and establishment of positive routines are needed to ensure high adherence with all preventive care regimens, including RTM.

Case Presentations

The following case series illustrates many of these clinical best practices and characterizes the potential benefits of RTM to veterans within the VA.

Case 1: Prevention After Healing

A veteran underwent a Chopart amputation and was recommended to use the mat after healing was perceived. Immediately on use of the study mat, the patient was found to have inflammation to the surgical incision (Figure 1). Clinical staff was alerted to the findings, and the patient was instructed to limit further walking and continue off-loading in his removable cast walker, per protocol. The inflammation of the operative foot quickly reduced, and the patient continued healing successfully, potentially avoiding incisional dehiscence and possible postoperative infection.

This case illustrates that patients’ wounds or surgical incisions may not be completely healed on epithelialization. In the immediate phase after closure, HCPs should consider additional protection to avoid complications. This case demonstrates that RTM can provide objective data to help guide care in that critical period.

Case 2: Identifying Preulcerative Lesions

An 88-year-old veteran had a chronic callus under the second metatarsal head. In addition to routine foot care and therapeutic shoes, he was followed with once-daily RTM. Inflammation was noted, and the veteran was seen in the podiatry clinic where debridement of the callus was performed. The difference in temperatures between feet detected by thermography prior to the clinic visits rapidly resolved after callus debridement, indicating that the underlying inflammation had subsided. RTM was used by the clinical staff to determine the appropriate time interval between clinic visits to avoid callus breakdown and subsequent ulceration.

Case 3: Extending the Clinic Into the Home

An 80-year-old veteran with T2DM and neuropathy was deemed a high-risk patient due to recurrent ulcerations to the left great toe. He was issued a RTM mat and was adherent with routine use. After nearly a year without hot-spot development, inflammation was noted (Figure 2).

Unfortunately, the patient had missed several routine foot care visits and likely that was the reason for the noted inflammation. The patient was called and became reengaged in regular visits for routine foot care. On debridement of his callus, a superficial, noninfected ulceration was discovered. Had remote monitoring not detected the inflammation and impending ulceration, the patient likely would not have been seen in the regular clinic and may have developed a wound infection, potentially resulting in a worse and more costly outcome.

Paradigm Shift to Prevention

Given the exceedingly high burden of diabetic foot complications in the VA, a paradigm shift is needed among HCPs from a culture of treatment to one of prevention. Bus and colleagues reported that in Europe, for every euro spent on ulcer prevention, 10 are spent on ulcer healing, and for every randomized clinical trial conducted on prevention, 10 are conducted on treatment.^42-44 Hicks and colleagues showed that the cost of curative care for DFUs is 5 to 30 times greater than the cost of preventive care.⁴⁵ For RTM in high-risk cohorts (ie, PAVE level 3), the number-needed-to-treat for DFU prevention may be as low as 6, assuming that a 70% reduction in incidence is possible, consistent with previous research. In the year following a DFU, costs exceed $44,000.⁹ Thus, it seems natural that future direction in diabetic foot care should emphasize prevention strategies.

Foot ulcers that become infected often lead to hospitalization and result in an increased burden to an already overburdened VA health care system. Research suggests that about two-thirds of all diabetic foot costs are attributable to inpatient management.⁴⁶ The impact of diabetic foot complications on hospital resource utilization is staggering. A 2017 study by Skrepnik analyzed the risk of hospitalization for various diseases.⁴⁷ The investigators found that the inpatient admission odds ratio (OR) for congestive heart failure was 2.6, surpassed only by DFUs (OR, 3.4) and diabetic foot infection (OR, 6.7). A 2019 point-prevalence study found that > 10% of hospital admissions have a foot-related condition as the primary or secondary reason, and the majority of these are due to foot diseases, such as ulcers, infections, and Charcot neuroarthropathy.⁴⁸

It is therefore incumbent on VA HCPs to avert wound recurrence in the interest of avoiding veteran hospitalizations and for administrators to encourage and incentivize best practices for managing the diabetic foot, with an emphasis on prevention therapies. In evaluating the financial impact of prevention with foot RTM, administrators should consider that the cost benefit is likely to be realized across the medical center, with budgets related to inpatient management likely to receive the largest returns.

Prevention has the potential to rein in costs as well as reduce strain on the hospital and clinic by preventing outcomes that require frequent visits for treatment or hospitalization. Wound treatment is very burdensome to the clinic; patients require frequent (in many cases, weekly) examinations, and chronic wounds often require hospitalization, necessitating rounding and additional coordination in care. Thus, preventing wounds or reducing their severity at presentation substantially reduces burden on the clinic, even after accounting for the modest clinical resources needed to administer preventative care. For example, a brief examination may be necessary if the inflammation detected by the study mat is secondary to a callus that must be debrided. However, if the patient was not seen until the callus had progressed to a wound, weekly follow-up and substantial clinical and budgetary resources may be required to heal the wound. Preventive care allows for substantially better patient outcomes, and the minimal time invested prevents the clinical burden of extensive wound treatment.

The success of preventive efforts relies on multidisciplinary management of this high-risk patient cohort. Often, it is the responsibility of the primary care provider to follow diabetic foot clinical reminders and appropriately refer to specialty care. Successful, open communication between PACT, PAVE, and the Podiatry Service has been shown to reduce poor outcomes, including lower extremity amputations. Traditionally, the model of preventive care has included podiatrist-driven interventions, including integrated routine foot care and comprehensive diabetic foot education. Collaboration between routine evaluation and prompt referral of at-risk patients for specialist foot care, therapeutic footwear recommendations, daily self-foot examinations, and in-home temperature monitoring are critically effective when performed consistently.

When trying to translate research science to effective clinical practice for preventing lower extremity complication, there are several important concepts. First, given the frequency of examination for patients being treated for a wound, provision of good preventive care, such as RTM, can reduce overall burden to resource-constrained clinics and improve access for patients needing to be seen. Additionally, preventive efforts extend clinical practice into the home and may reduce the need for in-clinic examinations and routine follow-up visits. Finally, there may be a sense of trust established between the clinician and patient with a positive record of adherence with preventive practices. This may translate into more productive communication and less frequent routine visits to better accommodate urgent visits and ensure podiatric care is accessible to veterans.

Conclusions

There is a significant opportunity to shift diabetic foot care from treatment to prevention, improving veteran outcomes and reducing resource utilization. RTM is an evidence-based and recommended but underused telemedicine solution that can catalyze this needed paradigm shift. The VA has been at the forefront of preventive foot care through the PAVE program and more recently through research and clinical application of RTM for veterans. However, as the data presented suggest, more can be done to improve veteran outcomes. More widespread adoption of evidence-based preventive technologies for the diabetic foot, such as RTM, has the potential to dramatically improve the quality of and access to care and reduce costs and burden on resource-constrained clinics.

Diabetic foot ulcers (DFUs) are devastating, common, and costly. This burden is borne disproportionately by veterans who have high prevalence of type 2 diabetes mellitus (T2DM) and other precipitating risk factors.¹ The mortality of veterans following a DFU is sobering, and ulceration is recognized as a significant marker of disease severity.

A 2017 study by Brennan and colleagues reported a 19% mortality rate within 1 year, and only 29% survive past 5 years.² DFUs are often complicated by peripheral arterial disease (PAD) and diabetic immune dysfunction, contributing to chronic wounds and infection.^3,4 About 60% of all foot ulcers become infected, and > 20% of patients with a diabetic foot infection require amputation.^5,6

A 2010 retrospective study reports that > 3,400 veterans have a diabetes-related lower extremity amputation annually, vastly surpassing the rate of amputation secondary to trauma in the Veterans Health Administration (VHA).^7,8 The inpatient costs for each amputation exceeded $60,000 in fiscal year 2010, and these amputation-related costs represent only 1 component of the total expense to the VHA attributable to diabetic foot complications.⁷ A recent systematic review by Chan and colleagues estimated mean annual costs in the year following a foot ulcer to be $44,200 to the public payer.⁹ This implies that direct expenditures for treatment of DFUs within the VHA exceeds $3 billion annually.

Diabetic Foot Ulcer Prevention

Given the dramatic impact of diabetic foot complications to the veteran and the US health care system, the VHA has long recognized the importance of preventive care for those at risk. In 2017 US Department of Veterans Affairs (VA) and Department of Defense issued a clinical practice guideline for the management of T2DM that recommended prophylactic foot care for early identification of any deformity or skin breakdown.¹⁰ The guidelines note that a “person who has had a foot ulcer is at lifelong risk of further ulceration,” reflecting the high rate of recurrence among all patients, including veterans. Multiple studies suggest that as many as 40% of patients experience recidivism in the first year after healing from a wound.^11-16

The VA is well equipped to deliver quality preventive care because of its innovative and long-standing PAVE (Prevention of Amputations for Veterans Everywhere) program.¹⁷ PAVE provides screening, education, appropriate footwear, and stratified care guidelines for veterans at risk for diabetes-related foot complications (Table 1). The practices encouraged by PAVE are evidence-based and synergistic with the objectives of the VA’s patient aligned care team (PACT) delivery approach.¹⁸ The granular data collected through PAVE are used to guide best practices and provide benchmarks for diabetic foot outcomes.

Unfortunately, despite PAVE guidelines requiring annual specialist foot care for at-risk veterans, a 2013 report by the VA Office of the Inspector General (OIG) found that one-third of all patients had no documentation of this minimal requirement of preventive foot care.¹⁹ Although the VA has worked to address this issue, the data hint at the missed opportunities for prevention of complications and the challenges of ensuring that a large at-risk veteran population has systematic and routine screening with access to specialist foot care.

Given the large proportion of veterans at high risk of chronic wound formation and the challenges of ensuring that this cohort receives good preventive foot care, expanding telemedicine has been suggested. Telemedicine solutions have the potential to reduce the impact of chronic wounds on overburdened clinic resources, schedules, and local and federal budgets.²⁰ Interestingly, the only preventive practice for the diabetic foot that has been proven effective through multiple randomized controlled trials and national and international clinical guidance documents is once-daily foot temperature monitoring.^21-26 Daily monitoring has the potential to reduce the burden of DFUs to veterans, improve veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications. Yet despite a recent national guidance document detailing its appropriate use in PAVE 3 veterans, it remains underutilized.²⁷

The purpose of this review is to: (1) discuss the evidence supporting once-daily remote temperature monitoring (RTM), a telemedicine approach critical to improving both veteran access to care and diabetic foot outcomes; (2) summarize a 2017 study that presented an advanced clinical understanding of RTM use among veterans; (3) provide previously unpublished data from this study comparing high-risk VA and non-VA cohorts, highlighting the opportunity for additional focus on foot ulcer prevention within the VA; and (4) report on recent VA utilization of a RTM technology based on this research, emphasizing lessons learned and best practices.

Remote Temperature Monitoring

The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot neuroarthropathy episodes. The patient and care team then act to resolve the cause of detected inflammation before clinical presentation (prevention) and begin treatment earlier than would otherwise be possible to avoid expensive complications, such as infection (early detection). Preventive therapies are low risk to the patient and inexpensive.

RTM is recommended by multiple clinical practice guidelines, including those of the International Working Group on the Diabetic Foot, the American College of Foot and Ankle Surgeons, and the Wound Healing Society.^24-26 Its use is supported by evidence from 3 National Institutes of Health-funded and well-designed randomized controlled trials, 1 of which was additionally supported by a VA Health Services Research and Development Service Merit Award.^21-23,28 Conducted between 2004 and 2007, these studies demonstrated the potential to reduce foot ulcer incidence by as much as 85% using a dermal thermometer to identify inflammation and prompt decreased ambulation. Investigators established a clinical monitoring protocol comparing the temperatures between 6 matched locations on the left and right feet. Persistent differences in contralateral temperatures exceeding 2.2°C (4.0°F) were used as a marker for elevated risk and to initiate preventive care. Based on the encouraging results from these studies, a 2017 effectiveness review prepared for the Agency for Healthcare Research and Quality concluded that “home monitoring of foot skin temperature is effective for reducing foot ulcer incidence and recurrence.”²⁹

Accuracy of RTM

A 2017 longitudinal study (NCT02647346) has provided novel data to advance understanding of RTM for the prediction and prevention of DFUs.³⁰ This study was the first to systematically analyze the accuracy of RTM over different monitoring thresholds. The results enable practitioners to deliver risk-stratified preventive care. Policy makers can use the data from this study to weigh the cost and benefits of RTM for population health.

The multicenter trials had 129 participants from 4 VA health care systems: VA Long Beach Healthcare System in California, Miami VA Healthcare System in Florida, Phoenix VA Healthcare System in Arizona, and VA West Los Angeles Healthcare System in California. Each participant was followed for 34 weeks under standard preventive foot care and was instructed to step on a telemedicine SmartMat (Podimetrics, Inc) RTM mat for 20 seconds daily. Participants and investigators were blinded to the temperature data so that the accuracy of temperature monitoring could be assessed. All participants had a history of T2DM and healed DFU. Principal exclusion criteria included unhealed plantar wound, history of proximal lower extremity amputation (ie, above ankle), active Charcot foot disease, and comorbidities that could potentially inhibit an inflammatory response, such as end-stage renal disease, active malignancy, and immunosuppressive diseases.

The investigators reported that RTM with the study mat detected 97% of nonacute plantar DFUs using the most commonly studied threshold (sustained 2.2°C temperature difference). The lead time averaged 37 days before clinical identification of the wound under standard care. Although the false-positive rate of 57% was high, corresponding to approximately 3.0 notifications per patient per year on average in the research setting, it is important to note that this study only considered the prediction of plantar DFUs. Thus, detection of foot inflammation secondary to other conditions, such as preulcerative lesion, dorsal wound, Charcot neuroarthropathy, or foot infection, were reported as a false positive per the study’s definitions. Further, Crisologo and Lavery noted in a translational medicine summary of this research, because the intervention is noninvasive and minimally impactful to the patient and the health care system, “the potential to arrest re-ulceration is worth the perceived inconvenience to the patient.”³¹

Secondary outcomes related to adherence and ease of use were encouraging. Eighty-eight percent of participants reported that the mat was “very easy to use,” the highest possible score, and 98% were able to set up the mat for home use without difficulty. At the end of the 34-week study, more than 74% of participants remained engaged in routine use of the mat under a per-protocol assessment of adherence. These results are especially impressive given the documented poor adherence of at-risk patients to routine use of therapeutic footwear, which has been reported to be as low as 15%.³²

New Research

The data collected during this study has led to new research and advancements in RTM. A recent publication by Gordon and colleagues investigated whether RTM is less accurate in cohorts with perceived challenges.³³ They include patients with recently healed wounds and those with a history of partial foot amputation. There was no difference in the accuracy or lead time for either cohort relative to the entire cohort, suggesting that RTM is appropriate for monitoring patients with recently healed DFUs or partial foot amputations.

In another recent study, the data were used to derive a novel approach to monitor a single at-risk foot.³⁴ The practice of RTM has traditionally required comparing temperatures between contralaterally matched plantar locations on the feet, thus limiting its use in patients with a history of major lower extremity amputation and patients being treated for a wound, which may be bandaged or in an off-loading cast or boot. Because the risk factors for DFUs exist in both limbs, these patients are at high risk for developing complications to the contralateral foot and may benefit from preventive once-daily foot temperature monitoring. The investigators empirically derived a novel monitoring approach for patients without a contralateral control. This approach was found to predict 91% of impending plantar DFUs on average 41 days before clinical presentation with a false positive rate of 54%.

Additional Focus on Prevention

Table 2 shows previously unpublished data from a subgroup analysis between veteran and nonveteran participants in the study.²⁵ These descriptive statistics reinforce some widely held assumptions regarding the high-risk veteran population and challenge others. For example, compared with the nonveteran participants, the veteran cohort unsurprisingly had a larger ratio of male participants (P < .01), had a higher rate of cigarette use (P < .01), and was more likely to live alone (although not at a statistically significant level). Veterans in the study had body mass index, rates of alcohol use, frequency of exercise, and glucose control comparable to that of nonveterans.

The potential impact of the PAVE program is clear in several of these comparisons. Although as few as 15% of patients use therapeutic shoes routinely, PAVE ensures that the majority of veterans receive them. Nearly 95% of veterans have therapeutic shoes compared with about 80% of nonveteran participants (P < .05). Veterans also had higher ankle-brachial index results (P < .05), although on average both cohorts were within normal clinical parameters. Veterans had a significantly longer duration since healing from the most recent wound, and fewer veteran participants had a wound that healed in the 3 months prior to the study. Despite this, during the study veterans had annualized DFU incidence equal to that of nonveterans. Furthermore, veterans also had significantly higher rates of amputation prior to participation. That these critical outcomes for veterans are no better than those observed in other care environments despite PAVE suggests that approaches recommended via PAVE alone are insufficient to significantly arrest DFU recurrence, and even more focus on prevention in the VA may be warranted.

From Research to Practice

Since the publication of the 2017 study, the VHA has been at the vanguard of translating the evidence and research underlying RTM into clinical practice. A clinical guidance document governing appropriate use of RTM with the study mat was recently published by the VA Prosthetic and Sensory Aids Service in collaboration with the National Podiatry Program office.²⁷ This guidance document recommends once-daily RTM for at-risk veterans designated PAVE level 3. It defines roles and responsibilities required for the successful implementation of a RTM program with the study device. The document additionally presents various clinical monitoring protocols for veterans, although the protocol and thresholds used are at the discretion of the prescribing clinician and should reflect the risk profile of the veteran in question.

A staged response to inflammation has proven popular, whereby an initial high-sensitivity threshold is chosen for monitoring. The initial response is telephone outreach by a designee supplied by the clinic or device manufacturer, typically a trained registered nurse, to the veteran to collect subjective history and instruct off-loading and reduced ambulation, with a target of 50% baseline reduction in step count. Should the inflammation persist despite off-loading, an examination may be necessary to identify and resolve its cause. For recalcitrant inflammation, more targeted pressure off-loading of the affected area may be accomplished with custom orthotics, accommodative insoles, removable cast walkers, and total contact casting. After 2 to 4 weeks without signs of inflammation, the cause is deemed to have been resolved and lowered the acute risk for developing further diabetic foot complications.

More than 600 veterans have been monitored for > 1,000 patient-years—13 VA medical centers are practicing RTM with the study mat as of this writing. The monitoring program has been integrated into many veteran daily routines as evidenced by > 70% retaining full engagement after having been monitored for > 1 year. The total number of alerts/patient-years across these veterans has been 1.4, significantly lower than the 3.0 alerts/patient-year observed in the study. This is potentially due to successful interventions in response to detected inflammation, resolving inflammation, and avoiding unnecessary alerts occurring in the research setting, which did not employ interventions that resolved inflammation episodes. In the past 6 months, 68% of all inflammation detected resolved via off-loading alone without requiring further clinical intervention. In the cases that required an examination, 76% of patients reported clinically meaningful preventive care (eg, preulcerative callus was debrided, a subungual hemorrhage was treated, a foot ulcer was identified).

Organizational Best Practices

Several best practices have been cultivated related to initiating a RTM program at a new site, for promoting the success of a RTM program, and provisioning excellent preventive care to support the RTM program. Although we advise adhering to the recommendations in the VA guidance document,²⁷ the authors have observed several additional organizational best practices that are not explicitly addressed.

Partnering with PACT. Collaboration between PAVE and PACT has the potential not only to improve outcomes for patients at risk for diabetic foot complications, but also can help identify appropriate high-risk veteran candidates for preventive care with RTM who may not be followed for routine care from a specialty provider, such as a podiatrist, as highlighted by the 2013 OIG report.

Prescreening eligible patients. Several programs have used PAVE data or appointment schedules to identify and target high-risk veterans proactively. This approach has several benefits. It simplifies clinical coordination and streamlines workflow for patient identification and onboarding. It also allows those veterans at highest risk to receive needed and recommended preventive care at their next scheduled appointment. Finally, if PAVE data are used to identify eligible patients, it has the added benefit of ensuring a baseline level of telemedicine preventive foot care for veterans who have become lost to follow-up and have not been seen recently for a routine foot examination.

Implementing foot monitoring during wound treatment. Recent research has expanded the reach of once-daily RTM with the mat to patients being treated for a wound to only 1 foot. This practice has 2 benefits: The patient is able to establish a preventive routine before healing, an important advantage because research strongly suggests that recurrence is most likely in the first months after healing. Second, 48% of patients with a history of DFUs will develop new wounds to the contralateral foot because risk factors, such as neuropathy and peripheral arterial disease, exist in both limbs.³⁵ Furthermore, ongoing treatment for a wound to 1 foot may result in gait deviation and elevated pressure to the sound foot, additionally predisposing the veteran to complications, resulting in a high rate of wounds occurring to the unwounded foot during treatment (0.2 DFU/DFU-year).³⁴ Thus, there is potential benefit in monitoring the sound foot while undergoing treatment for a wound; further, the patient will have immediate access to the device for prevention of recurrence once the wound has resolved.

Utilizing foot monitoring as an extension of telemedicine. Many VA facilities have large geographic catchment areas, making routine follow-up difficult for veterans living in rural areas. RTM serves as an extension of the patient’s daily self-examination and the clinician’s ability to monitor patients with objective information daily. The veterans using the system become more invested and feel as though they are taking an active role in their health care.

Investing in ongoing medical education. Multidisciplinary education sessions reviewing supporting clinical data and resultant clinical practice guidelines raise awareness for those providers and trainees unaware of preventive best practices for the diabetic foot, including those related to foot RTM. These sessions also are helpful for those familiar with foot temperature monitoring or who are responsible for administration of an ongoing program to remain current with contemporary best practices and to discuss improvements for patient care. Familiarity also can help address clinical inertia when benefits and evidence are clearly communicated with health care providers (HCPs).

Clinical Best Practices

Treating preulcerative lesions urgently and aggressively. Callus and other preulcerative lesions often cause progressive tissue damage and poor outcomes. When identified, these lesions should be promptly treated to ensure best outcomes.²⁴

Recognizing the limits of patient self-examinations. Comorbidities such as visual impairment and reduced joint mobility often preclude patients from completing rigorous self-examinations of the foot, which is especially critical while collecting subjective history from the patient during triage of inflammation. A caregiver or spouse can help inspect the foot during outreach and provide additional context.³⁶

Interpreting a benign foot on examination. Because RTM has been demonstrated to detect inflammation preceding a foot ulcer as many as 5 weeks before presentation to the clinic, some veterans may have few signs or symptoms of acute risk during examination. Often, the damage is to subcutaneous tissue resulting from repetitive microtrauma. Research suggests that clinical examination in these cases is often unreliable for identifying the earliest signs of risk, such as palpation to identify subtle temperature changes secondary to inflammation.³⁷ If a patient has refractory inflammation requiring examination and presents with an otherwise unremarkable foot, it is an opportunity to evaluate whether the patient’s shoewear remains appropriate or has worn out, to communicate the veteran’s ongoing elevated risk, and to educate on the importance of diligence in daily foot self-examinations, daily use of the foot temperature monitoring, and continued off-loading until the inflammation resolves.

Communicating the distinction between healing and remission. Although healing is the goal of wound care, patients should be educated that the underlying disease remains after epithelialization. In some cases, tissue deep to the skin has not completed remodeling, and the patient is at acute risk of recurrence. Remission is a powerful metaphor that better describes the patient’s ongoing risk to encourage continued healthy routines and diligent self-care.³⁸Considering the entirety of both feet for recurrence. Critical risk factors for diabetic foot complications, such as peripheral neuropathy and PAD, exist in both limbs, and patients with a history of wounds often develop new complications to different ipsilateral locations, or in as many as 48% of cases, to the contralateral foot.³⁵ For best outcomes, detected inflammation should be treated aggressively independent of whether the location coincides with an area of previous concern.

Encouraging adherence, routine, and empowerment. Advanced diabetes mellitus and neuropathy may impact a patient’s executive function, and multiple studies have reported that patients at risk for inflammatory foot diseases exhibit fatalism toward their foot care and outcomes.^39-41 Consistent education, encouragement, empowerment, and establishment of positive routines are needed to ensure high adherence with all preventive care regimens, including RTM.

Case Presentations

The following case series illustrates many of these clinical best practices and characterizes the potential benefits of RTM to veterans within the VA.

Case 1: Prevention After Healing

A veteran underwent a Chopart amputation and was recommended to use the mat after healing was perceived. Immediately on use of the study mat, the patient was found to have inflammation to the surgical incision (Figure 1). Clinical staff was alerted to the findings, and the patient was instructed to limit further walking and continue off-loading in his removable cast walker, per protocol. The inflammation of the operative foot quickly reduced, and the patient continued healing successfully, potentially avoiding incisional dehiscence and possible postoperative infection.

This case illustrates that patients’ wounds or surgical incisions may not be completely healed on epithelialization. In the immediate phase after closure, HCPs should consider additional protection to avoid complications. This case demonstrates that RTM can provide objective data to help guide care in that critical period.

Case 2: Identifying Preulcerative Lesions

An 88-year-old veteran had a chronic callus under the second metatarsal head. In addition to routine foot care and therapeutic shoes, he was followed with once-daily RTM. Inflammation was noted, and the veteran was seen in the podiatry clinic where debridement of the callus was performed. The difference in temperatures between feet detected by thermography prior to the clinic visits rapidly resolved after callus debridement, indicating that the underlying inflammation had subsided. RTM was used by the clinical staff to determine the appropriate time interval between clinic visits to avoid callus breakdown and subsequent ulceration.

Case 3: Extending the Clinic Into the Home

An 80-year-old veteran with T2DM and neuropathy was deemed a high-risk patient due to recurrent ulcerations to the left great toe. He was issued a RTM mat and was adherent with routine use. After nearly a year without hot-spot development, inflammation was noted (Figure 2).

Unfortunately, the patient had missed several routine foot care visits and likely that was the reason for the noted inflammation. The patient was called and became reengaged in regular visits for routine foot care. On debridement of his callus, a superficial, noninfected ulceration was discovered. Had remote monitoring not detected the inflammation and impending ulceration, the patient likely would not have been seen in the regular clinic and may have developed a wound infection, potentially resulting in a worse and more costly outcome.

Paradigm Shift to Prevention

Given the exceedingly high burden of diabetic foot complications in the VA, a paradigm shift is needed among HCPs from a culture of treatment to one of prevention. Bus and colleagues reported that in Europe, for every euro spent on ulcer prevention, 10 are spent on ulcer healing, and for every randomized clinical trial conducted on prevention, 10 are conducted on treatment.^42-44 Hicks and colleagues showed that the cost of curative care for DFUs is 5 to 30 times greater than the cost of preventive care.⁴⁵ For RTM in high-risk cohorts (ie, PAVE level 3), the number-needed-to-treat for DFU prevention may be as low as 6, assuming that a 70% reduction in incidence is possible, consistent with previous research. In the year following a DFU, costs exceed $44,000.⁹ Thus, it seems natural that future direction in diabetic foot care should emphasize prevention strategies.

Foot ulcers that become infected often lead to hospitalization and result in an increased burden to an already overburdened VA health care system. Research suggests that about two-thirds of all diabetic foot costs are attributable to inpatient management.⁴⁶ The impact of diabetic foot complications on hospital resource utilization is staggering. A 2017 study by Skrepnik analyzed the risk of hospitalization for various diseases.⁴⁷ The investigators found that the inpatient admission odds ratio (OR) for congestive heart failure was 2.6, surpassed only by DFUs (OR, 3.4) and diabetic foot infection (OR, 6.7). A 2019 point-prevalence study found that > 10% of hospital admissions have a foot-related condition as the primary or secondary reason, and the majority of these are due to foot diseases, such as ulcers, infections, and Charcot neuroarthropathy.⁴⁸

It is therefore incumbent on VA HCPs to avert wound recurrence in the interest of avoiding veteran hospitalizations and for administrators to encourage and incentivize best practices for managing the diabetic foot, with an emphasis on prevention therapies. In evaluating the financial impact of prevention with foot RTM, administrators should consider that the cost benefit is likely to be realized across the medical center, with budgets related to inpatient management likely to receive the largest returns.

Prevention has the potential to rein in costs as well as reduce strain on the hospital and clinic by preventing outcomes that require frequent visits for treatment or hospitalization. Wound treatment is very burdensome to the clinic; patients require frequent (in many cases, weekly) examinations, and chronic wounds often require hospitalization, necessitating rounding and additional coordination in care. Thus, preventing wounds or reducing their severity at presentation substantially reduces burden on the clinic, even after accounting for the modest clinical resources needed to administer preventative care. For example, a brief examination may be necessary if the inflammation detected by the study mat is secondary to a callus that must be debrided. However, if the patient was not seen until the callus had progressed to a wound, weekly follow-up and substantial clinical and budgetary resources may be required to heal the wound. Preventive care allows for substantially better patient outcomes, and the minimal time invested prevents the clinical burden of extensive wound treatment.

The success of preventive efforts relies on multidisciplinary management of this high-risk patient cohort. Often, it is the responsibility of the primary care provider to follow diabetic foot clinical reminders and appropriately refer to specialty care. Successful, open communication between PACT, PAVE, and the Podiatry Service has been shown to reduce poor outcomes, including lower extremity amputations. Traditionally, the model of preventive care has included podiatrist-driven interventions, including integrated routine foot care and comprehensive diabetic foot education. Collaboration between routine evaluation and prompt referral of at-risk patients for specialist foot care, therapeutic footwear recommendations, daily self-foot examinations, and in-home temperature monitoring are critically effective when performed consistently.

When trying to translate research science to effective clinical practice for preventing lower extremity complication, there are several important concepts. First, given the frequency of examination for patients being treated for a wound, provision of good preventive care, such as RTM, can reduce overall burden to resource-constrained clinics and improve access for patients needing to be seen. Additionally, preventive efforts extend clinical practice into the home and may reduce the need for in-clinic examinations and routine follow-up visits. Finally, there may be a sense of trust established between the clinician and patient with a positive record of adherence with preventive practices. This may translate into more productive communication and less frequent routine visits to better accommodate urgent visits and ensure podiatric care is accessible to veterans.

Conclusions

There is a significant opportunity to shift diabetic foot care from treatment to prevention, improving veteran outcomes and reducing resource utilization. RTM is an evidence-based and recommended but underused telemedicine solution that can catalyze this needed paradigm shift. The VA has been at the forefront of preventive foot care through the PAVE program and more recently through research and clinical application of RTM for veterans. However, as the data presented suggest, more can be done to improve veteran outcomes. More widespread adoption of evidence-based preventive technologies for the diabetic foot, such as RTM, has the potential to dramatically improve the quality of and access to care and reduce costs and burden on resource-constrained clinics.

The impeachment trial has concluded. By the time you read this editorial, Super Tuesday will be over. Then there will be the political party conventions, and finally the general election. Politics is everywhere and will be for the rest of 2020. As a preventive ethics measure, the legal arms of almost every federal agency will be sending cautionary e-mails to employees to remind us that any political activity undertaken must comply with the Hatch Act. Many of you who have worked in federal health care for some years may have heard a fellow employee say, “be careful you don’t violate the Hatch Act.”

Most readers probably had not heard of the statute before entering federal service. And you may have had an experience similar to mine in my early federal career when through osmosis I absorbed my peers fear and trembling when the Hatch Act was mentioned. This was the situation even though you were not at all sure you understood what the lawyers were warning you not to do. In my decades in federal service, I have heard that the Hatch Act dictates everything from you cannot vote to you can run for political office.

All this makes the timing right to review a piece of legislation that governs the political actions of every federal health and administrative professional. The Hatch Act sets apart federal employees from many, if not most, of our civilian counterparts, who, depending on your perspective, have more freedom to express their political views or are not held to such a high standard of ethical conduct.

In legalese, the Hatch Act is Political Activity Authorized; Prohibitions, 5 USC §7323 (1939). The title of this editorial, “To Prevent Pernicious Political Activities” is the formal title of the Hatch Act enacted at a time when government legislation was written in more ornamental rhetoric than the staid language of the current bureaucratic style. The alliterative title phrase of the act is an apt, if dated, encapsulation of the legislative intention of the act, which in modern parlance:

The law’s purpose is to ensure that federal programs are administered in a nonpartisan fashion, to protect federal employees from political coercion in the workplace, and to ensure that federal employees are advanced based on merit and not based on political affiliation. ²

For all its poetic turn of phrase, the title is historically accurate. The Hatch Act was passed in response to rampant partisan activity in public office. It was a key part of an effort to professionalize civil service, and as an essential aspect of that process, to protect federal employees from widespread political influence. The ethical principle behind the legislation is the one that still stands as the ideal for federal practitioners: to serve the people and act for the good of the public and republic.

The Hatch Act was intended to prevent unscrupulous politicians from intimidating federal employees and usurping the machinery of major government agencies to achieve their political ambitions. Imagine if your supervisor was running for office or supporting a particular candidate and ordered you to put a campaign sign in your yard, attend a political rally, and wear a campaign button on your lapel or you would be fired. All that and far worse happened in the good old USA before the Hatch Act.³

The Office of Special Counsel (OSC) is the authoritative guardian of the Hatch Act providing opinions on whether an activity is permitted under the act; investigating compliance with the provisions of the act; taking disciplinary action against the employee for serious violations; and prosecuting those violations before the Merit Systems Protection Board. Now I understand why the incantation “Hatch Act” casts a chill on our civil service souls. While there have been recent allegations against a high-profile political appointee, federal practitioners are not immune to prosecution.⁴ In 2017, Federal Times reported that the OSC sought disciplinary action against a VA physician for 15 violations of the Hatch Act after he ran for a state Senate seat in 2014.⁵

Fortunately, the OSC has produced a handy list of “Though Shalt Nots” and “You Cans” as a guide to the Hatch Act.⁶ Only the highpoints are mentioned here:

• Thou shalt not be a candidate for nomination or election to a partisan public office;
• Thou shalt not use a position of official public authority to influence or interfere with the result of an election;
• Thou shalt not solicit or host, accept, or receive a donation or contribution to a partisan political party, candidate, or group; and
• Thou shalt not engage in political activity on behalf of a partisan political party, candidate, or group while on duty, in a federal space, wearing a federal uniform, or driving a federal vehicle.

Covered under these daunting prohibitions is ordinary American politicking like hosting fundraisers or inviting your coworkers to a political rally, distributing campaign materials, and wearing a T-shirt with your favorite candidates smiling face at work. The new hotbed of concern for the Hatch Act is, you guessed it, social media—you cannot use your blog, Facebook, Instagram, or e-mail account to comment pro or con for a partisan candidate, party, office, or group.⁶

You may be asking at this point whether you can even watch the political debates? Yes, that is allowed under the Hatch Act along with running for nonpartisan election and participating in nonpartisan campaigns; voting, and registering others to vote; you can contribute money to political campaigns, parties, or partisan groups; attend political rallies, meetings and fundraisers; and even join a political party. Of course these activities must be on your own time and dime, not that of your federal employer. All of these “You Cans” enable a federal employee to engage in the bare minimum of democracy: voting in elections, but opponents argue they bar the civil servant from fully participating in the complex richness of the American political process.⁷

Nonetheless, since its inception the Hatch Act has been a matter of fierce debate among federal employees and other advocates of civil liberties. Those who feel it should be relaxed contend that the modern merit-based system of government service has rendered the provisions of the Hatch Act unnecessary, even obsolete. In addition, unlike in 1939, critics of the act claim there are now formidable whistleblower protections for employees who experience political coercion. Over the years there have been several efforts to weaken the conflict of interest safeguards that the act contains, leading many commentators to think that some of the amendments and reforms have blurred the tight boundaries between the professional and the political. Others such as the government unions and the American Civil Liberties Union (ACLU) believe that the tight line drawn between public and private binds the liberty of civil servants.⁸ Those who defend the Hatch Act believe that the wall it erects between professional and personal in the realm of political activities for federal employees must remain high and strong to protect the integrity of the administrative branch and the public trust.⁹

So, as political advertisements dominate television programming and the texts never stop asking for campaign donations, you can cast your own vote for or against the Hatch Act. As for me and my house, we will follow President Jefferson in preferring to be the property of the people rather than be indebted to the powerful. You need never encounter a true conflict of interest if you have no false conflict of obligation: history teaches us that serving 2 masters usually turns out badly for the slave. Many of you will completely disagree with my stance, holding that your constitutional rights as a citizen are being curtailed, if not outright denied, simply because you choose to serve your country. Our ability to freely hold and express our differences of opinions about the Hatch Act and so much else is what keeps democracy alive.

The impeachment trial has concluded. By the time you read this editorial, Super Tuesday will be over. Then there will be the political party conventions, and finally the general election. Politics is everywhere and will be for the rest of 2020. As a preventive ethics measure, the legal arms of almost every federal agency will be sending cautionary e-mails to employees to remind us that any political activity undertaken must comply with the Hatch Act. Many of you who have worked in federal health care for some years may have heard a fellow employee say, “be careful you don’t violate the Hatch Act.”

Most readers probably had not heard of the statute before entering federal service. And you may have had an experience similar to mine in my early federal career when through osmosis I absorbed my peers fear and trembling when the Hatch Act was mentioned. This was the situation even though you were not at all sure you understood what the lawyers were warning you not to do. In my decades in federal service, I have heard that the Hatch Act dictates everything from you cannot vote to you can run for political office.

All this makes the timing right to review a piece of legislation that governs the political actions of every federal health and administrative professional. The Hatch Act sets apart federal employees from many, if not most, of our civilian counterparts, who, depending on your perspective, have more freedom to express their political views or are not held to such a high standard of ethical conduct.

In legalese, the Hatch Act is Political Activity Authorized; Prohibitions, 5 USC §7323 (1939). The title of this editorial, “To Prevent Pernicious Political Activities” is the formal title of the Hatch Act enacted at a time when government legislation was written in more ornamental rhetoric than the staid language of the current bureaucratic style. The alliterative title phrase of the act is an apt, if dated, encapsulation of the legislative intention of the act, which in modern parlance:

The law’s purpose is to ensure that federal programs are administered in a nonpartisan fashion, to protect federal employees from political coercion in the workplace, and to ensure that federal employees are advanced based on merit and not based on political affiliation. ²

For all its poetic turn of phrase, the title is historically accurate. The Hatch Act was passed in response to rampant partisan activity in public office. It was a key part of an effort to professionalize civil service, and as an essential aspect of that process, to protect federal employees from widespread political influence. The ethical principle behind the legislation is the one that still stands as the ideal for federal practitioners: to serve the people and act for the good of the public and republic.

The Hatch Act was intended to prevent unscrupulous politicians from intimidating federal employees and usurping the machinery of major government agencies to achieve their political ambitions. Imagine if your supervisor was running for office or supporting a particular candidate and ordered you to put a campaign sign in your yard, attend a political rally, and wear a campaign button on your lapel or you would be fired. All that and far worse happened in the good old USA before the Hatch Act.³

The Office of Special Counsel (OSC) is the authoritative guardian of the Hatch Act providing opinions on whether an activity is permitted under the act; investigating compliance with the provisions of the act; taking disciplinary action against the employee for serious violations; and prosecuting those violations before the Merit Systems Protection Board. Now I understand why the incantation “Hatch Act” casts a chill on our civil service souls. While there have been recent allegations against a high-profile political appointee, federal practitioners are not immune to prosecution.⁴ In 2017, Federal Times reported that the OSC sought disciplinary action against a VA physician for 15 violations of the Hatch Act after he ran for a state Senate seat in 2014.⁵

Fortunately, the OSC has produced a handy list of “Though Shalt Nots” and “You Cans” as a guide to the Hatch Act.⁶ Only the highpoints are mentioned here:

• Thou shalt not be a candidate for nomination or election to a partisan public office;
• Thou shalt not use a position of official public authority to influence or interfere with the result of an election;
• Thou shalt not solicit or host, accept, or receive a donation or contribution to a partisan political party, candidate, or group; and
• Thou shalt not engage in political activity on behalf of a partisan political party, candidate, or group while on duty, in a federal space, wearing a federal uniform, or driving a federal vehicle.

Covered under these daunting prohibitions is ordinary American politicking like hosting fundraisers or inviting your coworkers to a political rally, distributing campaign materials, and wearing a T-shirt with your favorite candidates smiling face at work. The new hotbed of concern for the Hatch Act is, you guessed it, social media—you cannot use your blog, Facebook, Instagram, or e-mail account to comment pro or con for a partisan candidate, party, office, or group.⁶

You may be asking at this point whether you can even watch the political debates? Yes, that is allowed under the Hatch Act along with running for nonpartisan election and participating in nonpartisan campaigns; voting, and registering others to vote; you can contribute money to political campaigns, parties, or partisan groups; attend political rallies, meetings and fundraisers; and even join a political party. Of course these activities must be on your own time and dime, not that of your federal employer. All of these “You Cans” enable a federal employee to engage in the bare minimum of democracy: voting in elections, but opponents argue they bar the civil servant from fully participating in the complex richness of the American political process.⁷

Nonetheless, since its inception the Hatch Act has been a matter of fierce debate among federal employees and other advocates of civil liberties. Those who feel it should be relaxed contend that the modern merit-based system of government service has rendered the provisions of the Hatch Act unnecessary, even obsolete. In addition, unlike in 1939, critics of the act claim there are now formidable whistleblower protections for employees who experience political coercion. Over the years there have been several efforts to weaken the conflict of interest safeguards that the act contains, leading many commentators to think that some of the amendments and reforms have blurred the tight boundaries between the professional and the political. Others such as the government unions and the American Civil Liberties Union (ACLU) believe that the tight line drawn between public and private binds the liberty of civil servants.⁸ Those who defend the Hatch Act believe that the wall it erects between professional and personal in the realm of political activities for federal employees must remain high and strong to protect the integrity of the administrative branch and the public trust.⁹

So, as political advertisements dominate television programming and the texts never stop asking for campaign donations, you can cast your own vote for or against the Hatch Act. As for me and my house, we will follow President Jefferson in preferring to be the property of the people rather than be indebted to the powerful. You need never encounter a true conflict of interest if you have no false conflict of obligation: history teaches us that serving 2 masters usually turns out badly for the slave. Many of you will completely disagree with my stance, holding that your constitutional rights as a citizen are being curtailed, if not outright denied, simply because you choose to serve your country. Our ability to freely hold and express our differences of opinions about the Hatch Act and so much else is what keeps democracy alive.

The impeachment trial has concluded. By the time you read this editorial, Super Tuesday will be over. Then there will be the political party conventions, and finally the general election. Politics is everywhere and will be for the rest of 2020. As a preventive ethics measure, the legal arms of almost every federal agency will be sending cautionary e-mails to employees to remind us that any political activity undertaken must comply with the Hatch Act. Many of you who have worked in federal health care for some years may have heard a fellow employee say, “be careful you don’t violate the Hatch Act.”

Most readers probably had not heard of the statute before entering federal service. And you may have had an experience similar to mine in my early federal career when through osmosis I absorbed my peers fear and trembling when the Hatch Act was mentioned. This was the situation even though you were not at all sure you understood what the lawyers were warning you not to do. In my decades in federal service, I have heard that the Hatch Act dictates everything from you cannot vote to you can run for political office.

All this makes the timing right to review a piece of legislation that governs the political actions of every federal health and administrative professional. The Hatch Act sets apart federal employees from many, if not most, of our civilian counterparts, who, depending on your perspective, have more freedom to express their political views or are not held to such a high standard of ethical conduct.

In legalese, the Hatch Act is Political Activity Authorized; Prohibitions, 5 USC §7323 (1939). The title of this editorial, “To Prevent Pernicious Political Activities” is the formal title of the Hatch Act enacted at a time when government legislation was written in more ornamental rhetoric than the staid language of the current bureaucratic style. The alliterative title phrase of the act is an apt, if dated, encapsulation of the legislative intention of the act, which in modern parlance:

The law’s purpose is to ensure that federal programs are administered in a nonpartisan fashion, to protect federal employees from political coercion in the workplace, and to ensure that federal employees are advanced based on merit and not based on political affiliation. ²

For all its poetic turn of phrase, the title is historically accurate. The Hatch Act was passed in response to rampant partisan activity in public office. It was a key part of an effort to professionalize civil service, and as an essential aspect of that process, to protect federal employees from widespread political influence. The ethical principle behind the legislation is the one that still stands as the ideal for federal practitioners: to serve the people and act for the good of the public and republic.

The Hatch Act was intended to prevent unscrupulous politicians from intimidating federal employees and usurping the machinery of major government agencies to achieve their political ambitions. Imagine if your supervisor was running for office or supporting a particular candidate and ordered you to put a campaign sign in your yard, attend a political rally, and wear a campaign button on your lapel or you would be fired. All that and far worse happened in the good old USA before the Hatch Act.³

The Office of Special Counsel (OSC) is the authoritative guardian of the Hatch Act providing opinions on whether an activity is permitted under the act; investigating compliance with the provisions of the act; taking disciplinary action against the employee for serious violations; and prosecuting those violations before the Merit Systems Protection Board. Now I understand why the incantation “Hatch Act” casts a chill on our civil service souls. While there have been recent allegations against a high-profile political appointee, federal practitioners are not immune to prosecution.⁴ In 2017, Federal Times reported that the OSC sought disciplinary action against a VA physician for 15 violations of the Hatch Act after he ran for a state Senate seat in 2014.⁵

Fortunately, the OSC has produced a handy list of “Though Shalt Nots” and “You Cans” as a guide to the Hatch Act.⁶ Only the highpoints are mentioned here:

• Thou shalt not be a candidate for nomination or election to a partisan public office;
• Thou shalt not use a position of official public authority to influence or interfere with the result of an election;
• Thou shalt not solicit or host, accept, or receive a donation or contribution to a partisan political party, candidate, or group; and
• Thou shalt not engage in political activity on behalf of a partisan political party, candidate, or group while on duty, in a federal space, wearing a federal uniform, or driving a federal vehicle.

Covered under these daunting prohibitions is ordinary American politicking like hosting fundraisers or inviting your coworkers to a political rally, distributing campaign materials, and wearing a T-shirt with your favorite candidates smiling face at work. The new hotbed of concern for the Hatch Act is, you guessed it, social media—you cannot use your blog, Facebook, Instagram, or e-mail account to comment pro or con for a partisan candidate, party, office, or group.⁶

You may be asking at this point whether you can even watch the political debates? Yes, that is allowed under the Hatch Act along with running for nonpartisan election and participating in nonpartisan campaigns; voting, and registering others to vote; you can contribute money to political campaigns, parties, or partisan groups; attend political rallies, meetings and fundraisers; and even join a political party. Of course these activities must be on your own time and dime, not that of your federal employer. All of these “You Cans” enable a federal employee to engage in the bare minimum of democracy: voting in elections, but opponents argue they bar the civil servant from fully participating in the complex richness of the American political process.⁷

Nonetheless, since its inception the Hatch Act has been a matter of fierce debate among federal employees and other advocates of civil liberties. Those who feel it should be relaxed contend that the modern merit-based system of government service has rendered the provisions of the Hatch Act unnecessary, even obsolete. In addition, unlike in 1939, critics of the act claim there are now formidable whistleblower protections for employees who experience political coercion. Over the years there have been several efforts to weaken the conflict of interest safeguards that the act contains, leading many commentators to think that some of the amendments and reforms have blurred the tight boundaries between the professional and the political. Others such as the government unions and the American Civil Liberties Union (ACLU) believe that the tight line drawn between public and private binds the liberty of civil servants.⁸ Those who defend the Hatch Act believe that the wall it erects between professional and personal in the realm of political activities for federal employees must remain high and strong to protect the integrity of the administrative branch and the public trust.⁹

So, as political advertisements dominate television programming and the texts never stop asking for campaign donations, you can cast your own vote for or against the Hatch Act. As for me and my house, we will follow President Jefferson in preferring to be the property of the people rather than be indebted to the powerful. You need never encounter a true conflict of interest if you have no false conflict of obligation: history teaches us that serving 2 masters usually turns out badly for the slave. Many of you will completely disagree with my stance, holding that your constitutional rights as a citizen are being curtailed, if not outright denied, simply because you choose to serve your country. Our ability to freely hold and express our differences of opinions about the Hatch Act and so much else is what keeps democracy alive.

ORLANDO – Collecting and storing extra stem cells on the off chance that a patient with multiple myeloma will need a salvage autologous stem cell transplant may not be worth the money or effort, investigators say.

Neil Osterweil/MDedge News

Among patients with multiple myeloma who had adequate collection of mobilized and stored cells, only 3 of 146 eligible patients were given the stored cells in a second autologous stem cell transplant (ASCT), reported Nausheen Ahmed, MD, from the Case Western Reserve Cancer Center and University Hospitals Seidman Cancer Center, both in Cleveland.

“We found overall low utilization of salvage transplants and storage stem cells at our institution, which may not justify the strategy of early collection for all patients fit for transplant,” she said at the Transplantation and Cellular Therapy Meetings.

But Sergio Giralt, MD, a transplant specialist from Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study, warned against changing practice “for the wrong reason, because it’s just a financial reason.”
 

Get them while they’re fresh

The rationale for collecting and storing extra cells is the risk that mobilization will fail in the future following prolonged maintenance with immunomodulatory agents such as lenalidomide (Revlimid), and the risk for genetic or epigenetic damage to cells from high-dose melphalan used in transplant-conditioning regimens, Dr. Ahmed noted at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“However, there are potential issues with early mobilization and storage, including cost, resources, apheresis scheduling, uncertainty of cell viability, and liability. There’s also risk of side effects with filgrastim and plerixafor use [for mobilization],” she said.

Dr. Ahmed and colleagues conducted a study to determine how stored stem cells for second ASCT were used, describe how second ASCTs are used in patients who meet the Mayo Consensus Stratification for Myeloma & Risk-Adapted Therapy (mSMART) criteria, and the costs of mobilizing and storing stem cells for a second ASCT.

They took a retrospective look at all adults aged 18 years and older with a diagnosis of multiple myeloma who received a first ASCT at their institution from 2009 to 2017. They excluded patients who had amyloidosis without myeloma or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) syndrome.

Patients were considered eligible for a second ASCT based on mSMART recommendations if they had a relapse either 18 or more months without maintenance therapy or after at least 36 months on maintenance. The investigators defined an extra day of collection as an additional day of apheresis to obtain 2 million or more CD34 cells/kg for storage only.

They estimated costs from the institution’s charge master as the sum of cell processing, leukapheresis costs, additional plerixafor costs, and storage costs, and calculated the total duration of storage as months from the date of collection until the last follow-up.

The median age of the total study population of 179 patients was 61 years, with a majority of male and white patients. Of this group, 98% had an Eastern Cooperative Oncology Group performance score of 0-1. In all, 63.7% of the patients had standard-risk cytogenetics, 22.4% had high-risk disease, and the remainder had unknown cytogenetic risk.

At a median follow-up of 56.5 months, 95 patients (53.1%) had experienced a relapse after transplant with a median time to progression of 47.5 months. The majority of patients (166; 92.7%) had received a single transplant, 10 (5.6%) had received tandem transplants, and only 3 (1.6%) had a second transplant at relapse.

Looking at the use of second transplant in patients who met the criteria for salvage transplant based on mSMART (excluding patients who had undergone tandem transplant) and whose maintenance status was known, they identified 61 patients on maintenance therapy and 24 with no maintenance. A total of 31 patients (18 in the maintenance group and 13 in the no-maintenance group) met mSMART criteria for salvage ASCT.

Dr. Ahmed and colleagues next looked at the 146 patients who had at least 2 million stored cells/kg, and found that the stored cells were used for only three patients. Of the 146 patients, 66 had 1 extra collection day, 17 had 2 extra days, and 4 had 3 extra days, for an average additional cost per patient of $16,859.
 

‘Woefully underutilized’

Discussing the study, Dr. Giralt asked: “How valid are the SMART criteria of 36 months? And the answer is there is no data to support it, and if we actually go back to our oncology, any patient who has had more than 18 months without exposure to a drug can continue to have sensitivity to that drug, and that’s why if we used the ASBMT criteria of greater than 18 months you’d have a larger population” of patients eligible for salvage transplant.

He stated that, “we know these patients exist, we know they have cells in the freezer, but we’re not using those cells. Second transplant is woefully underutilized in myeloma patients,” and he added that stored cells could also be used to support those patients who develop cytopenias following chimeric antigen receptor (CAR) T-cell therapy.

Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center, Houston, who comoderated the session where the data were presented, agreed with Dr. Giralt that stored stem cells are underutilized in the treatment of patients with multiple myeloma.

“I don’t think that the experience from Case Western, where the percentage of patients who are eligible for salvage transplant and actually got it was less than 10%, can be extrapolated to many other centers. I think that in most centers the actual percentage is higher than that,” he said in an interview.

“There are going to be therapies like CAR T that will compete with salvage transplants, but I think more patients should be considered for this salvage procedure,” he added.

No funding source for the story was disclosed. Dr. Ahmed reported no financial disclosures. Dr. Giralt reported consulting/advisory activities and receiving research funding from multiple companies. Dr. Nieto disclosed research funding from, and consultancy for, several companies.

SOURCE: Ahmed N et al. TCT 2020, Abstract 28.

ORLANDO – Collecting and storing extra stem cells on the off chance that a patient with multiple myeloma will need a salvage autologous stem cell transplant may not be worth the money or effort, investigators say.

Neil Osterweil/MDedge News

Among patients with multiple myeloma who had adequate collection of mobilized and stored cells, only 3 of 146 eligible patients were given the stored cells in a second autologous stem cell transplant (ASCT), reported Nausheen Ahmed, MD, from the Case Western Reserve Cancer Center and University Hospitals Seidman Cancer Center, both in Cleveland.

“We found overall low utilization of salvage transplants and storage stem cells at our institution, which may not justify the strategy of early collection for all patients fit for transplant,” she said at the Transplantation and Cellular Therapy Meetings.

But Sergio Giralt, MD, a transplant specialist from Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study, warned against changing practice “for the wrong reason, because it’s just a financial reason.”
 

Get them while they’re fresh

The rationale for collecting and storing extra cells is the risk that mobilization will fail in the future following prolonged maintenance with immunomodulatory agents such as lenalidomide (Revlimid), and the risk for genetic or epigenetic damage to cells from high-dose melphalan used in transplant-conditioning regimens, Dr. Ahmed noted at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“However, there are potential issues with early mobilization and storage, including cost, resources, apheresis scheduling, uncertainty of cell viability, and liability. There’s also risk of side effects with filgrastim and plerixafor use [for mobilization],” she said.

Dr. Ahmed and colleagues conducted a study to determine how stored stem cells for second ASCT were used, describe how second ASCTs are used in patients who meet the Mayo Consensus Stratification for Myeloma & Risk-Adapted Therapy (mSMART) criteria, and the costs of mobilizing and storing stem cells for a second ASCT.

They took a retrospective look at all adults aged 18 years and older with a diagnosis of multiple myeloma who received a first ASCT at their institution from 2009 to 2017. They excluded patients who had amyloidosis without myeloma or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) syndrome.

Patients were considered eligible for a second ASCT based on mSMART recommendations if they had a relapse either 18 or more months without maintenance therapy or after at least 36 months on maintenance. The investigators defined an extra day of collection as an additional day of apheresis to obtain 2 million or more CD34 cells/kg for storage only.

They estimated costs from the institution’s charge master as the sum of cell processing, leukapheresis costs, additional plerixafor costs, and storage costs, and calculated the total duration of storage as months from the date of collection until the last follow-up.

The median age of the total study population of 179 patients was 61 years, with a majority of male and white patients. Of this group, 98% had an Eastern Cooperative Oncology Group performance score of 0-1. In all, 63.7% of the patients had standard-risk cytogenetics, 22.4% had high-risk disease, and the remainder had unknown cytogenetic risk.

At a median follow-up of 56.5 months, 95 patients (53.1%) had experienced a relapse after transplant with a median time to progression of 47.5 months. The majority of patients (166; 92.7%) had received a single transplant, 10 (5.6%) had received tandem transplants, and only 3 (1.6%) had a second transplant at relapse.

Looking at the use of second transplant in patients who met the criteria for salvage transplant based on mSMART (excluding patients who had undergone tandem transplant) and whose maintenance status was known, they identified 61 patients on maintenance therapy and 24 with no maintenance. A total of 31 patients (18 in the maintenance group and 13 in the no-maintenance group) met mSMART criteria for salvage ASCT.

Dr. Ahmed and colleagues next looked at the 146 patients who had at least 2 million stored cells/kg, and found that the stored cells were used for only three patients. Of the 146 patients, 66 had 1 extra collection day, 17 had 2 extra days, and 4 had 3 extra days, for an average additional cost per patient of $16,859.
 

‘Woefully underutilized’

Discussing the study, Dr. Giralt asked: “How valid are the SMART criteria of 36 months? And the answer is there is no data to support it, and if we actually go back to our oncology, any patient who has had more than 18 months without exposure to a drug can continue to have sensitivity to that drug, and that’s why if we used the ASBMT criteria of greater than 18 months you’d have a larger population” of patients eligible for salvage transplant.

He stated that, “we know these patients exist, we know they have cells in the freezer, but we’re not using those cells. Second transplant is woefully underutilized in myeloma patients,” and he added that stored cells could also be used to support those patients who develop cytopenias following chimeric antigen receptor (CAR) T-cell therapy.

Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center, Houston, who comoderated the session where the data were presented, agreed with Dr. Giralt that stored stem cells are underutilized in the treatment of patients with multiple myeloma.

“I don’t think that the experience from Case Western, where the percentage of patients who are eligible for salvage transplant and actually got it was less than 10%, can be extrapolated to many other centers. I think that in most centers the actual percentage is higher than that,” he said in an interview.

“There are going to be therapies like CAR T that will compete with salvage transplants, but I think more patients should be considered for this salvage procedure,” he added.

No funding source for the story was disclosed. Dr. Ahmed reported no financial disclosures. Dr. Giralt reported consulting/advisory activities and receiving research funding from multiple companies. Dr. Nieto disclosed research funding from, and consultancy for, several companies.

SOURCE: Ahmed N et al. TCT 2020, Abstract 28.

ORLANDO – Collecting and storing extra stem cells on the off chance that a patient with multiple myeloma will need a salvage autologous stem cell transplant may not be worth the money or effort, investigators say.

Neil Osterweil/MDedge News

Among patients with multiple myeloma who had adequate collection of mobilized and stored cells, only 3 of 146 eligible patients were given the stored cells in a second autologous stem cell transplant (ASCT), reported Nausheen Ahmed, MD, from the Case Western Reserve Cancer Center and University Hospitals Seidman Cancer Center, both in Cleveland.

“We found overall low utilization of salvage transplants and storage stem cells at our institution, which may not justify the strategy of early collection for all patients fit for transplant,” she said at the Transplantation and Cellular Therapy Meetings.

But Sergio Giralt, MD, a transplant specialist from Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study, warned against changing practice “for the wrong reason, because it’s just a financial reason.”
 

Get them while they’re fresh

The rationale for collecting and storing extra cells is the risk that mobilization will fail in the future following prolonged maintenance with immunomodulatory agents such as lenalidomide (Revlimid), and the risk for genetic or epigenetic damage to cells from high-dose melphalan used in transplant-conditioning regimens, Dr. Ahmed noted at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

“However, there are potential issues with early mobilization and storage, including cost, resources, apheresis scheduling, uncertainty of cell viability, and liability. There’s also risk of side effects with filgrastim and plerixafor use [for mobilization],” she said.

Dr. Ahmed and colleagues conducted a study to determine how stored stem cells for second ASCT were used, describe how second ASCTs are used in patients who meet the Mayo Consensus Stratification for Myeloma & Risk-Adapted Therapy (mSMART) criteria, and the costs of mobilizing and storing stem cells for a second ASCT.

They took a retrospective look at all adults aged 18 years and older with a diagnosis of multiple myeloma who received a first ASCT at their institution from 2009 to 2017. They excluded patients who had amyloidosis without myeloma or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) syndrome.

Patients were considered eligible for a second ASCT based on mSMART recommendations if they had a relapse either 18 or more months without maintenance therapy or after at least 36 months on maintenance. The investigators defined an extra day of collection as an additional day of apheresis to obtain 2 million or more CD34 cells/kg for storage only.

They estimated costs from the institution’s charge master as the sum of cell processing, leukapheresis costs, additional plerixafor costs, and storage costs, and calculated the total duration of storage as months from the date of collection until the last follow-up.

The median age of the total study population of 179 patients was 61 years, with a majority of male and white patients. Of this group, 98% had an Eastern Cooperative Oncology Group performance score of 0-1. In all, 63.7% of the patients had standard-risk cytogenetics, 22.4% had high-risk disease, and the remainder had unknown cytogenetic risk.

At a median follow-up of 56.5 months, 95 patients (53.1%) had experienced a relapse after transplant with a median time to progression of 47.5 months. The majority of patients (166; 92.7%) had received a single transplant, 10 (5.6%) had received tandem transplants, and only 3 (1.6%) had a second transplant at relapse.

Looking at the use of second transplant in patients who met the criteria for salvage transplant based on mSMART (excluding patients who had undergone tandem transplant) and whose maintenance status was known, they identified 61 patients on maintenance therapy and 24 with no maintenance. A total of 31 patients (18 in the maintenance group and 13 in the no-maintenance group) met mSMART criteria for salvage ASCT.

Dr. Ahmed and colleagues next looked at the 146 patients who had at least 2 million stored cells/kg, and found that the stored cells were used for only three patients. Of the 146 patients, 66 had 1 extra collection day, 17 had 2 extra days, and 4 had 3 extra days, for an average additional cost per patient of $16,859.
 

‘Woefully underutilized’

Discussing the study, Dr. Giralt asked: “How valid are the SMART criteria of 36 months? And the answer is there is no data to support it, and if we actually go back to our oncology, any patient who has had more than 18 months without exposure to a drug can continue to have sensitivity to that drug, and that’s why if we used the ASBMT criteria of greater than 18 months you’d have a larger population” of patients eligible for salvage transplant.

He stated that, “we know these patients exist, we know they have cells in the freezer, but we’re not using those cells. Second transplant is woefully underutilized in myeloma patients,” and he added that stored cells could also be used to support those patients who develop cytopenias following chimeric antigen receptor (CAR) T-cell therapy.

Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center, Houston, who comoderated the session where the data were presented, agreed with Dr. Giralt that stored stem cells are underutilized in the treatment of patients with multiple myeloma.

“I don’t think that the experience from Case Western, where the percentage of patients who are eligible for salvage transplant and actually got it was less than 10%, can be extrapolated to many other centers. I think that in most centers the actual percentage is higher than that,” he said in an interview.

“There are going to be therapies like CAR T that will compete with salvage transplants, but I think more patients should be considered for this salvage procedure,” he added.

No funding source for the story was disclosed. Dr. Ahmed reported no financial disclosures. Dr. Giralt reported consulting/advisory activities and receiving research funding from multiple companies. Dr. Nieto disclosed research funding from, and consultancy for, several companies.

SOURCE: Ahmed N et al. TCT 2020, Abstract 28.

PHOENIX – The level of physical activity people engage in during their golden years doesn’t have to be strenuous in order to be effective, results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.

Courtesy University of California, San Diego

In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.

The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.

“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”

For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.

Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.

She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”

Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”

Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”

In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.

Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.

“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.

According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”

The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.

During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.

“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.

He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”

“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”

Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.

[email protected]

SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.

PHOENIX – The level of physical activity people engage in during their golden years doesn’t have to be strenuous in order to be effective, results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.

Courtesy University of California, San Diego

In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.

The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.

“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”

For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.

Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.

She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”

Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”

Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”

In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.

Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.

“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.

According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”

The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.

During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.

“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.

He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”

“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”

Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.

[email protected]

SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.

PHOENIX – The level of physical activity people engage in during their golden years doesn’t have to be strenuous in order to be effective, results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.

Courtesy University of California, San Diego

In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.

The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.

“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”

For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.

Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.

She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”

Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”

Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”

In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.

Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.

“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.

According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”

The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.

During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.

“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.

He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”

“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”

Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.

[email protected]

SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.

Over the past years, I have had the opportunity to attend countless lectures on burnout provided by colleagues spanning across many fields in mental health and health care in general. The talks generally follow a common narration: 1. Your work is important and meaningful to many. 2. Your work requires significant training, dedication, and passion. 3. While you get personal gratification from your work, it does come with a cost. 4. This cost can be great and can affect you physically and mentally. 5. This cost is called burnout.

Burnout is described as irritability (poor mood), low energy, poor concentration, difficulty appreciating enjoyable things (anhedonia), and poor sleep, among other symptoms, as a result of work stress. At this point in the lectures, I usually ask whomever is sitting next to me: “I came in late, is this a lecture on depression?” to which the answer is typically “No! Of course not, this is about ‘burnout’ not mental illness.” And here lies a concern about burnout: Is burnout a concept describing depression that we have repackaged to protect professionals from the stigmatization of mental illness? Does our tendency not to characterize patients’ struggles as burnout stigmatize them – and imply that their employment is not challenging to cause burnout?

According to the literature, a range of factors affects burnout in professionals: lack of control, unclear job expectations, dysfunctional workplace dynamics, extremes of activity, lack of social support, work-life imbalance. Contrary to depression, burnout is not caused by neurobiological problems. Patients with burnout don’t have chemical imbalances, hyperactive default mode networks, or overactive amygdalas. Burnout is caused by social factors and affects dedicated, caring, and exceptional individuals who have been pushed outside their window of tolerance.

Literature suggests a variety of remedies to treat burnout: Reevaluate your employment, discuss occupational concerns with your supervisor, discuss with colleagues, receive help from your social support system, and seek human resources services. In addition, experts recommend engaging in relaxing activities, improving your sleep hygiene, exercising regularly, and participating in mindfulness to reduce symptoms. Contrary to depression, burnout does not require individuals to fix their maladaptive thoughts or discover inadequate unconscious beliefs that may be affecting their work. Contrary to depression, burnout does not require the rebalancing of neurochemistry using psychotropic medication.

The concept of burnout engenders concerns. I fear that it divides physicians and patients into two different classes and thus further stigmatizes those with mental illness. It implies that we physicians are somehow immune from mental illness and its consequences. We do not suffer from brain abnormalities, we do not require mind-altering medications, we are not “mentally ill.” Contrarily, at times it might be implied that patients’ jobs are not important enough to cause burnout; if they feel sad, anhedonic, have poor energy and poor sleep, it is because they have mental illness. Their brains are inadequate and flawed. But for physicians, our brains are intact, just pushed beyond human capabilities.

I should point out that I do not think that burnout experts believe or desire to promote such concepts. I am not aware of burnout experts championing physician exceptionalism or promoting the stigmatization of patients. I believe that this problem is an unintended consequence, a side effect, of the idea of burnout itself.

Another concern I have is that the concept of burnout may actually hinder physicians from seeking necessary and appropriate professional services to address symptoms. Interestingly, most lectures I have attended on burnout have not discussed the concerning number of physicians who end their lives by suicide. Burnout can give physicians the impression that their problems are social and occupational, thus not requiring a medical solution or intervention. There was a time when I argued against the removal of the grief exclusion in the DSM; I worried that we were pathologizing natural emotional reactions to trauma. However, I have come to realize that, if someone is debilitated by depression, seeking professional help should not be predicated on the trigger. As such, I would recommend the vast number of physicians who state burnout in surveys to seriously consider the possibility that they may, in fact, be suffering from mental illness. We encourage our patients to seek help and speak out against stigmatization; isn’t it time that we as professionals should not be afraid to do the same?

I have concerns about the concept of burnout, but I certainly do not think that we should get rid of the idea. On the contrary, I applaud this attempt at de-pathologizing, and de-medicalizing human suffering. As many have argued with more or less success and controversy of the years, many emotional problems are not best suited to be treated by psychotropic medication or even psychiatry. I think that psychiatry should embrace paradigms that include social and occupational constructs of emotional pain, not rooted in diseases and/or chemical imbalances. Such paradigms should, furthermore, not be limited to certain professions or life circumstances. We are all affected by human suffering. Access and willingness to appropriate care or support should not be granted only to those with a mental illness diagnosis.

Burnout is a promising idea that challenges our conceptualization of mental disorders. Burnout brings a humanity to emotional pain frequently lost in the medicalized diagnoses of the DSM. Psychiatry should seriously consider opening its door to nonmedicalized understanding of psychological suffering. By opening those doors, we begin to create a less medicalized construct for human suffering. We begin to create one based on shared human experience.
 

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Springer, 2019).

Over the past years, I have had the opportunity to attend countless lectures on burnout provided by colleagues spanning across many fields in mental health and health care in general. The talks generally follow a common narration: 1. Your work is important and meaningful to many. 2. Your work requires significant training, dedication, and passion. 3. While you get personal gratification from your work, it does come with a cost. 4. This cost can be great and can affect you physically and mentally. 5. This cost is called burnout.

Burnout is described as irritability (poor mood), low energy, poor concentration, difficulty appreciating enjoyable things (anhedonia), and poor sleep, among other symptoms, as a result of work stress. At this point in the lectures, I usually ask whomever is sitting next to me: “I came in late, is this a lecture on depression?” to which the answer is typically “No! Of course not, this is about ‘burnout’ not mental illness.” And here lies a concern about burnout: Is burnout a concept describing depression that we have repackaged to protect professionals from the stigmatization of mental illness? Does our tendency not to characterize patients’ struggles as burnout stigmatize them – and imply that their employment is not challenging to cause burnout?

According to the literature, a range of factors affects burnout in professionals: lack of control, unclear job expectations, dysfunctional workplace dynamics, extremes of activity, lack of social support, work-life imbalance. Contrary to depression, burnout is not caused by neurobiological problems. Patients with burnout don’t have chemical imbalances, hyperactive default mode networks, or overactive amygdalas. Burnout is caused by social factors and affects dedicated, caring, and exceptional individuals who have been pushed outside their window of tolerance.

Literature suggests a variety of remedies to treat burnout: Reevaluate your employment, discuss occupational concerns with your supervisor, discuss with colleagues, receive help from your social support system, and seek human resources services. In addition, experts recommend engaging in relaxing activities, improving your sleep hygiene, exercising regularly, and participating in mindfulness to reduce symptoms. Contrary to depression, burnout does not require individuals to fix their maladaptive thoughts or discover inadequate unconscious beliefs that may be affecting their work. Contrary to depression, burnout does not require the rebalancing of neurochemistry using psychotropic medication.

The concept of burnout engenders concerns. I fear that it divides physicians and patients into two different classes and thus further stigmatizes those with mental illness. It implies that we physicians are somehow immune from mental illness and its consequences. We do not suffer from brain abnormalities, we do not require mind-altering medications, we are not “mentally ill.” Contrarily, at times it might be implied that patients’ jobs are not important enough to cause burnout; if they feel sad, anhedonic, have poor energy and poor sleep, it is because they have mental illness. Their brains are inadequate and flawed. But for physicians, our brains are intact, just pushed beyond human capabilities.

I should point out that I do not think that burnout experts believe or desire to promote such concepts. I am not aware of burnout experts championing physician exceptionalism or promoting the stigmatization of patients. I believe that this problem is an unintended consequence, a side effect, of the idea of burnout itself.

Another concern I have is that the concept of burnout may actually hinder physicians from seeking necessary and appropriate professional services to address symptoms. Interestingly, most lectures I have attended on burnout have not discussed the concerning number of physicians who end their lives by suicide. Burnout can give physicians the impression that their problems are social and occupational, thus not requiring a medical solution or intervention. There was a time when I argued against the removal of the grief exclusion in the DSM; I worried that we were pathologizing natural emotional reactions to trauma. However, I have come to realize that, if someone is debilitated by depression, seeking professional help should not be predicated on the trigger. As such, I would recommend the vast number of physicians who state burnout in surveys to seriously consider the possibility that they may, in fact, be suffering from mental illness. We encourage our patients to seek help and speak out against stigmatization; isn’t it time that we as professionals should not be afraid to do the same?

I have concerns about the concept of burnout, but I certainly do not think that we should get rid of the idea. On the contrary, I applaud this attempt at de-pathologizing, and de-medicalizing human suffering. As many have argued with more or less success and controversy of the years, many emotional problems are not best suited to be treated by psychotropic medication or even psychiatry. I think that psychiatry should embrace paradigms that include social and occupational constructs of emotional pain, not rooted in diseases and/or chemical imbalances. Such paradigms should, furthermore, not be limited to certain professions or life circumstances. We are all affected by human suffering. Access and willingness to appropriate care or support should not be granted only to those with a mental illness diagnosis.

Burnout is a promising idea that challenges our conceptualization of mental disorders. Burnout brings a humanity to emotional pain frequently lost in the medicalized diagnoses of the DSM. Psychiatry should seriously consider opening its door to nonmedicalized understanding of psychological suffering. By opening those doors, we begin to create a less medicalized construct for human suffering. We begin to create one based on shared human experience.
 

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Springer, 2019).

Over the past years, I have had the opportunity to attend countless lectures on burnout provided by colleagues spanning across many fields in mental health and health care in general. The talks generally follow a common narration: 1. Your work is important and meaningful to many. 2. Your work requires significant training, dedication, and passion. 3. While you get personal gratification from your work, it does come with a cost. 4. This cost can be great and can affect you physically and mentally. 5. This cost is called burnout.

Burnout is described as irritability (poor mood), low energy, poor concentration, difficulty appreciating enjoyable things (anhedonia), and poor sleep, among other symptoms, as a result of work stress. At this point in the lectures, I usually ask whomever is sitting next to me: “I came in late, is this a lecture on depression?” to which the answer is typically “No! Of course not, this is about ‘burnout’ not mental illness.” And here lies a concern about burnout: Is burnout a concept describing depression that we have repackaged to protect professionals from the stigmatization of mental illness? Does our tendency not to characterize patients’ struggles as burnout stigmatize them – and imply that their employment is not challenging to cause burnout?

According to the literature, a range of factors affects burnout in professionals: lack of control, unclear job expectations, dysfunctional workplace dynamics, extremes of activity, lack of social support, work-life imbalance. Contrary to depression, burnout is not caused by neurobiological problems. Patients with burnout don’t have chemical imbalances, hyperactive default mode networks, or overactive amygdalas. Burnout is caused by social factors and affects dedicated, caring, and exceptional individuals who have been pushed outside their window of tolerance.

Literature suggests a variety of remedies to treat burnout: Reevaluate your employment, discuss occupational concerns with your supervisor, discuss with colleagues, receive help from your social support system, and seek human resources services. In addition, experts recommend engaging in relaxing activities, improving your sleep hygiene, exercising regularly, and participating in mindfulness to reduce symptoms. Contrary to depression, burnout does not require individuals to fix their maladaptive thoughts or discover inadequate unconscious beliefs that may be affecting their work. Contrary to depression, burnout does not require the rebalancing of neurochemistry using psychotropic medication.

The concept of burnout engenders concerns. I fear that it divides physicians and patients into two different classes and thus further stigmatizes those with mental illness. It implies that we physicians are somehow immune from mental illness and its consequences. We do not suffer from brain abnormalities, we do not require mind-altering medications, we are not “mentally ill.” Contrarily, at times it might be implied that patients’ jobs are not important enough to cause burnout; if they feel sad, anhedonic, have poor energy and poor sleep, it is because they have mental illness. Their brains are inadequate and flawed. But for physicians, our brains are intact, just pushed beyond human capabilities.

I should point out that I do not think that burnout experts believe or desire to promote such concepts. I am not aware of burnout experts championing physician exceptionalism or promoting the stigmatization of patients. I believe that this problem is an unintended consequence, a side effect, of the idea of burnout itself.

Another concern I have is that the concept of burnout may actually hinder physicians from seeking necessary and appropriate professional services to address symptoms. Interestingly, most lectures I have attended on burnout have not discussed the concerning number of physicians who end their lives by suicide. Burnout can give physicians the impression that their problems are social and occupational, thus not requiring a medical solution or intervention. There was a time when I argued against the removal of the grief exclusion in the DSM; I worried that we were pathologizing natural emotional reactions to trauma. However, I have come to realize that, if someone is debilitated by depression, seeking professional help should not be predicated on the trigger. As such, I would recommend the vast number of physicians who state burnout in surveys to seriously consider the possibility that they may, in fact, be suffering from mental illness. We encourage our patients to seek help and speak out against stigmatization; isn’t it time that we as professionals should not be afraid to do the same?

I have concerns about the concept of burnout, but I certainly do not think that we should get rid of the idea. On the contrary, I applaud this attempt at de-pathologizing, and de-medicalizing human suffering. As many have argued with more or less success and controversy of the years, many emotional problems are not best suited to be treated by psychotropic medication or even psychiatry. I think that psychiatry should embrace paradigms that include social and occupational constructs of emotional pain, not rooted in diseases and/or chemical imbalances. Such paradigms should, furthermore, not be limited to certain professions or life circumstances. We are all affected by human suffering. Access and willingness to appropriate care or support should not be granted only to those with a mental illness diagnosis.

Burnout is a promising idea that challenges our conceptualization of mental disorders. Burnout brings a humanity to emotional pain frequently lost in the medicalized diagnoses of the DSM. Psychiatry should seriously consider opening its door to nonmedicalized understanding of psychological suffering. By opening those doors, we begin to create a less medicalized construct for human suffering. We begin to create one based on shared human experience.
 

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Springer, 2019).

A team of researchers has discovered important commonalities between SARS-CoV-2 and SARS-CoV infection that could lead to a potential targets for antiviral intervention.

Courtesy NIAID-RML

Markus Hoffmann, of the Leibniz Institute for Primate Research, Göttingen, Germany, and a team of investigators also found that antibody responses raised against SARS-S during infection or vaccination might offer some level of protection against SARS-CoV-2 infection. Their findings were published in Cell.

In order for coronaviruses to enter a cell, they must first bind their viral spike (S) proteins to cellular receptors and depend on S protein priming by host cell proteases. The study found that the SARS-CoV-2, causal agent for COVID-19, uses the same SARS-CoV receptor, ACE2, for entry and uses the serine protease TMPRSS2 for S protein priming as the original SARS-CoV-1 (SARS). Importantly, the researchers also found that the cellular serine protease TMPRSS2 primes SARS-CoV-2-S for entry and that a serine protease inhibitor blocks SARS-CoV-2 infection of lung cells, providing opportunities for potential therapeutic intervention.

The researchers performed a sequence analysis that showed SARS-CoV-2 clusters with SARS-CoV–related viruses from bats, of which some – but not all – can use ACE2 for host cell entry. Further analysis of the receptor binding motif known to make contact with ACE2 showed that most amino acid residues essential for ACE2 binding by SARS-S were conserved in SARS-2-S but were absent from S proteins of those SARS-related coronaviruses previously found not to use ACE2.

In addition, the researchers found that SARS-CoV-2–infected BHK-21 cells transfected to express ACE2 with high efficiency, but not the parental BHK-21 cells indicating that SARS-CoV-2-S, like the original SARS virus S protein, uses ACE2 for cellular entry.

Using cultured cells, the researchers found that the protease inhibitor, camostat mesylate, inhibited SARS-S and SARS-2-S entry into primary human lung cells, demonstrating that SARS-CoV-2 can use TMPRSS2 for S protein priming and that camostat mesylate can block SARS-CoV-2 infection of lung cells. Camostat mesylate has been used as a therapy for some forms of cancer and other viral infections.

In addition to their research on the protease inhibitor, the researchers also found that sera from convalescent SARS patients cross-neutralized SARS-2-S–driven entry. They found that four sera obtained from three convalescent SARS patients inhibited SARS-S entry into cell lines in a concentration dependent fashion.

“We demonstrate that SARS-CoV-2 uses the SARS55 CoV receptor, ACE2, for entry and the serine protease TMPRSS2 for S protein priming. A TMPRSS2 inhibitor approved for clinical use blocked entry and might constitute a treatment option. Finally, we show that the sera from convalescent SARS patients cross-neutralized SARS-2-S–driven entry,” the authors concluded.

The study was supported by BMBF (RAPID Consortium) and German Research Foundation (DFG). The authors reported that they had no conflicts.
 

[email protected]

SOURCE: Hoffmann M et al. Cell 2020. doi: 10.1016/j.cell.2020.02.052.

A team of researchers has discovered important commonalities between SARS-CoV-2 and SARS-CoV infection that could lead to a potential targets for antiviral intervention.

Courtesy NIAID-RML

Markus Hoffmann, of the Leibniz Institute for Primate Research, Göttingen, Germany, and a team of investigators also found that antibody responses raised against SARS-S during infection or vaccination might offer some level of protection against SARS-CoV-2 infection. Their findings were published in Cell.

In order for coronaviruses to enter a cell, they must first bind their viral spike (S) proteins to cellular receptors and depend on S protein priming by host cell proteases. The study found that the SARS-CoV-2, causal agent for COVID-19, uses the same SARS-CoV receptor, ACE2, for entry and uses the serine protease TMPRSS2 for S protein priming as the original SARS-CoV-1 (SARS). Importantly, the researchers also found that the cellular serine protease TMPRSS2 primes SARS-CoV-2-S for entry and that a serine protease inhibitor blocks SARS-CoV-2 infection of lung cells, providing opportunities for potential therapeutic intervention.

The researchers performed a sequence analysis that showed SARS-CoV-2 clusters with SARS-CoV–related viruses from bats, of which some – but not all – can use ACE2 for host cell entry. Further analysis of the receptor binding motif known to make contact with ACE2 showed that most amino acid residues essential for ACE2 binding by SARS-S were conserved in SARS-2-S but were absent from S proteins of those SARS-related coronaviruses previously found not to use ACE2.

In addition, the researchers found that SARS-CoV-2–infected BHK-21 cells transfected to express ACE2 with high efficiency, but not the parental BHK-21 cells indicating that SARS-CoV-2-S, like the original SARS virus S protein, uses ACE2 for cellular entry.

Using cultured cells, the researchers found that the protease inhibitor, camostat mesylate, inhibited SARS-S and SARS-2-S entry into primary human lung cells, demonstrating that SARS-CoV-2 can use TMPRSS2 for S protein priming and that camostat mesylate can block SARS-CoV-2 infection of lung cells. Camostat mesylate has been used as a therapy for some forms of cancer and other viral infections.

In addition to their research on the protease inhibitor, the researchers also found that sera from convalescent SARS patients cross-neutralized SARS-2-S–driven entry. They found that four sera obtained from three convalescent SARS patients inhibited SARS-S entry into cell lines in a concentration dependent fashion.

“We demonstrate that SARS-CoV-2 uses the SARS55 CoV receptor, ACE2, for entry and the serine protease TMPRSS2 for S protein priming. A TMPRSS2 inhibitor approved for clinical use blocked entry and might constitute a treatment option. Finally, we show that the sera from convalescent SARS patients cross-neutralized SARS-2-S–driven entry,” the authors concluded.

The study was supported by BMBF (RAPID Consortium) and German Research Foundation (DFG). The authors reported that they had no conflicts.
 

[email protected]

SOURCE: Hoffmann M et al. Cell 2020. doi: 10.1016/j.cell.2020.02.052.

A team of researchers has discovered important commonalities between SARS-CoV-2 and SARS-CoV infection that could lead to a potential targets for antiviral intervention.

Courtesy NIAID-RML

Markus Hoffmann, of the Leibniz Institute for Primate Research, Göttingen, Germany, and a team of investigators also found that antibody responses raised against SARS-S during infection or vaccination might offer some level of protection against SARS-CoV-2 infection. Their findings were published in Cell.

In order for coronaviruses to enter a cell, they must first bind their viral spike (S) proteins to cellular receptors and depend on S protein priming by host cell proteases. The study found that the SARS-CoV-2, causal agent for COVID-19, uses the same SARS-CoV receptor, ACE2, for entry and uses the serine protease TMPRSS2 for S protein priming as the original SARS-CoV-1 (SARS). Importantly, the researchers also found that the cellular serine protease TMPRSS2 primes SARS-CoV-2-S for entry and that a serine protease inhibitor blocks SARS-CoV-2 infection of lung cells, providing opportunities for potential therapeutic intervention.

The researchers performed a sequence analysis that showed SARS-CoV-2 clusters with SARS-CoV–related viruses from bats, of which some – but not all – can use ACE2 for host cell entry. Further analysis of the receptor binding motif known to make contact with ACE2 showed that most amino acid residues essential for ACE2 binding by SARS-S were conserved in SARS-2-S but were absent from S proteins of those SARS-related coronaviruses previously found not to use ACE2.

In addition, the researchers found that SARS-CoV-2–infected BHK-21 cells transfected to express ACE2 with high efficiency, but not the parental BHK-21 cells indicating that SARS-CoV-2-S, like the original SARS virus S protein, uses ACE2 for cellular entry.

Using cultured cells, the researchers found that the protease inhibitor, camostat mesylate, inhibited SARS-S and SARS-2-S entry into primary human lung cells, demonstrating that SARS-CoV-2 can use TMPRSS2 for S protein priming and that camostat mesylate can block SARS-CoV-2 infection of lung cells. Camostat mesylate has been used as a therapy for some forms of cancer and other viral infections.

In addition to their research on the protease inhibitor, the researchers also found that sera from convalescent SARS patients cross-neutralized SARS-2-S–driven entry. They found that four sera obtained from three convalescent SARS patients inhibited SARS-S entry into cell lines in a concentration dependent fashion.

“We demonstrate that SARS-CoV-2 uses the SARS55 CoV receptor, ACE2, for entry and the serine protease TMPRSS2 for S protein priming. A TMPRSS2 inhibitor approved for clinical use blocked entry and might constitute a treatment option. Finally, we show that the sera from convalescent SARS patients cross-neutralized SARS-2-S–driven entry,” the authors concluded.

The study was supported by BMBF (RAPID Consortium) and German Research Foundation (DFG). The authors reported that they had no conflicts.
 

[email protected]

SOURCE: Hoffmann M et al. Cell 2020. doi: 10.1016/j.cell.2020.02.052.