The number of new COVID-19 cases in children rose for the third time in the last 4 weeks, reaching the highest point since mid-February, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 73,000 cases were reported during the week of April 2-8, up by 14.6% over the previous week. For the latest week, children represented 18.8% of all COVID-19 cases in the United States – also up from the week before and the second-highest proportion seen during the entire pandemic, based on data in the weekly AAP/CHA report.

The 3.54 million children who have been infected with SARS-CoV-2 make up 13.5% of all cases reported in the United States during the pandemic, a figure that climbed again after 2 weeks at 13.4%. The overall rate of infection was just over 4,700 cases per 100,000 children as of April 8, the AAP and CHA said.

State-level data show that Vermont, Michigan, and Maine have been the COVID-19 hotspots over the past 2 weeks. The total number of cases has jumped by almost 19% in Vermont since the week of March 19-25, by 18% in Michigan, and by 12% in Maine, according to the report.

Cumulative data also indicate that the children of Vermont are bearing a greater share of the COVID-19 burden – 21.5% of all cases – than in any other state. North Dakota, meanwhile, has the highest cumulative rate of infection at 9,057 cases per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The number of COVID-19–related deaths in children increased by 8 during the week of April 2-8 and now stands at 292, just 0.06% of all deaths reported in the 43 states (along with New York City, Puerto Rico, and Guam) that provide age distributions for mortality data, the AAP and CHA said.

[email protected]

The number of new COVID-19 cases in children rose for the third time in the last 4 weeks, reaching the highest point since mid-February, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 73,000 cases were reported during the week of April 2-8, up by 14.6% over the previous week. For the latest week, children represented 18.8% of all COVID-19 cases in the United States – also up from the week before and the second-highest proportion seen during the entire pandemic, based on data in the weekly AAP/CHA report.

The 3.54 million children who have been infected with SARS-CoV-2 make up 13.5% of all cases reported in the United States during the pandemic, a figure that climbed again after 2 weeks at 13.4%. The overall rate of infection was just over 4,700 cases per 100,000 children as of April 8, the AAP and CHA said.

State-level data show that Vermont, Michigan, and Maine have been the COVID-19 hotspots over the past 2 weeks. The total number of cases has jumped by almost 19% in Vermont since the week of March 19-25, by 18% in Michigan, and by 12% in Maine, according to the report.

Cumulative data also indicate that the children of Vermont are bearing a greater share of the COVID-19 burden – 21.5% of all cases – than in any other state. North Dakota, meanwhile, has the highest cumulative rate of infection at 9,057 cases per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The number of COVID-19–related deaths in children increased by 8 during the week of April 2-8 and now stands at 292, just 0.06% of all deaths reported in the 43 states (along with New York City, Puerto Rico, and Guam) that provide age distributions for mortality data, the AAP and CHA said.

[email protected]

The number of new COVID-19 cases in children rose for the third time in the last 4 weeks, reaching the highest point since mid-February, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 73,000 cases were reported during the week of April 2-8, up by 14.6% over the previous week. For the latest week, children represented 18.8% of all COVID-19 cases in the United States – also up from the week before and the second-highest proportion seen during the entire pandemic, based on data in the weekly AAP/CHA report.

The 3.54 million children who have been infected with SARS-CoV-2 make up 13.5% of all cases reported in the United States during the pandemic, a figure that climbed again after 2 weeks at 13.4%. The overall rate of infection was just over 4,700 cases per 100,000 children as of April 8, the AAP and CHA said.

State-level data show that Vermont, Michigan, and Maine have been the COVID-19 hotspots over the past 2 weeks. The total number of cases has jumped by almost 19% in Vermont since the week of March 19-25, by 18% in Michigan, and by 12% in Maine, according to the report.

Cumulative data also indicate that the children of Vermont are bearing a greater share of the COVID-19 burden – 21.5% of all cases – than in any other state. North Dakota, meanwhile, has the highest cumulative rate of infection at 9,057 cases per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The number of COVID-19–related deaths in children increased by 8 during the week of April 2-8 and now stands at 292, just 0.06% of all deaths reported in the 43 states (along with New York City, Puerto Rico, and Guam) that provide age distributions for mortality data, the AAP and CHA said.

[email protected]

A dose-adjusted R-CHOP may be the best treatment for elderly patients with diffuse large beta-cell lymphoma (DLBCL), according to a review of 38 studies that examined this aged population.

Nephron/Wikimedia Commons/CC BY-SA 3.0

In addition, treatment choices based on new tools such as the Comprehensive Geriatric Assessment appeared to provide useful guidance based on the comorbidities and frailty index of this group of patients, according to Alda Tavares, MD, of Hospital Pedro Hispano, Matosinhos (Portugal) Local Health Unit, and Ilídia Moreira, MD, of the Portuguese Institute of Oncology of Porto.
 

Study characteristics

Of the 38 studies assessed, 13 were retrospective and 25 were phase II/III clinical trials. Most of these studies investigated the efficacy of dose-adjusted R-CHOP regimen, according to the review published online in Critical Reviews in Oncology/Hematology.

Alternative therapeutic drugs as well as the use of geriatric assessment were also investigated.

In terms of the elderly populations assessed, 11 out of 38 studies included at least 30 patients over age 80 years, although 11 other studies did not specify the number of patients older than 80 years. Eight of the studies included exclusively patients aged 80 years and over. Three of these studies were phase II trials.

Only six of the clinical trials required a geriatric assessment tool for inclusion criteria or therapeutic regime choice, using the Cumulative Illness Rating Scale–Geriatric (CIRS-G), the performance in activities of daily living (ADL) and/or instrumental activities of daily living (IADL) tools.

Most of the studies investigated the efficacy of R-CHOP regimen at different doses and variations, with 11 studies using alternative anthracycline in place of doxorubicin.
 

MiniCHOP mattered

Elderly patients over 80 years achieved complete response (CR) rates from 37.2% to 66.7% and 2-year overall survival (OS) from 31.9% to 64.7% across the studies reviewed. Overall, for fit patients aged 80 and over, the strongest evidence favored the use of an R-miniCHOP regimen, according to the authors.

In the 25 studies with treatment based on R-CHOP/modified R-CHOP or immunochemotherapy with an alternative anthracycline, the CR rate was below 50% in three studies and over 60% in the majority. Higher CR rates of 71%-88.9% were achieved in eight studies.

For patients over 80 years, the strongest evidence favored rituximab/ofatumumab-miniCHOP, based on two studies. In both studies, patients over 80 years old, without significant comorbidities, received CHOP regime with a dose reduction of about 50% (miniCHOP: cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and 1 mg vincristine on day 1 of each cycle, and prednisone 40 mg/m² on days 1-5) plus an anti–CD-20 antibody (rituximab 375 mg/m² or ofatumumab 1,000 mg). The first of these studies obtained CR rate of 62% and 2-year OS of 59% with low toxicities. The second study achieved slightly better results, according to the reviewers, who suggested the difference was possibly because of a prephase treatment and/or the use of ofatumumab.

One study group developed a simple prognostic model based on multivariate analysis of 108 patients aged 80 years and older treated in their study with R-CHOP at full (48%) or reduced dose (51%). Patients with at least two out of three risk factors (age > 85 years, revised International Prognostic Index score 3-5 and CIRS > 5) had worse survival than did those with 0-1 risk factors, with a median OS of 12 months vs. 45 months, P = .001, respectively).

“All these studies results favor the tailored treatment approach,” the reviewers stated. “More prospective studies are still needed to demonstrate and validate the adequate tools for the selection of patients and their optimal treatment. They would provide the grounds for clinical therapeutic decision, aiming for tailored treatment and fulfilling best individual expectations and outcome,” they concluded.

The authors reported that they received no research funds for the study and that they had no disclosures.
 

[email protected]

A dose-adjusted R-CHOP may be the best treatment for elderly patients with diffuse large beta-cell lymphoma (DLBCL), according to a review of 38 studies that examined this aged population.

Nephron/Wikimedia Commons/CC BY-SA 3.0

In addition, treatment choices based on new tools such as the Comprehensive Geriatric Assessment appeared to provide useful guidance based on the comorbidities and frailty index of this group of patients, according to Alda Tavares, MD, of Hospital Pedro Hispano, Matosinhos (Portugal) Local Health Unit, and Ilídia Moreira, MD, of the Portuguese Institute of Oncology of Porto.
 

Study characteristics

Of the 38 studies assessed, 13 were retrospective and 25 were phase II/III clinical trials. Most of these studies investigated the efficacy of dose-adjusted R-CHOP regimen, according to the review published online in Critical Reviews in Oncology/Hematology.

Alternative therapeutic drugs as well as the use of geriatric assessment were also investigated.

In terms of the elderly populations assessed, 11 out of 38 studies included at least 30 patients over age 80 years, although 11 other studies did not specify the number of patients older than 80 years. Eight of the studies included exclusively patients aged 80 years and over. Three of these studies were phase II trials.

Only six of the clinical trials required a geriatric assessment tool for inclusion criteria or therapeutic regime choice, using the Cumulative Illness Rating Scale–Geriatric (CIRS-G), the performance in activities of daily living (ADL) and/or instrumental activities of daily living (IADL) tools.

Most of the studies investigated the efficacy of R-CHOP regimen at different doses and variations, with 11 studies using alternative anthracycline in place of doxorubicin.
 

MiniCHOP mattered

Elderly patients over 80 years achieved complete response (CR) rates from 37.2% to 66.7% and 2-year overall survival (OS) from 31.9% to 64.7% across the studies reviewed. Overall, for fit patients aged 80 and over, the strongest evidence favored the use of an R-miniCHOP regimen, according to the authors.

In the 25 studies with treatment based on R-CHOP/modified R-CHOP or immunochemotherapy with an alternative anthracycline, the CR rate was below 50% in three studies and over 60% in the majority. Higher CR rates of 71%-88.9% were achieved in eight studies.

For patients over 80 years, the strongest evidence favored rituximab/ofatumumab-miniCHOP, based on two studies. In both studies, patients over 80 years old, without significant comorbidities, received CHOP regime with a dose reduction of about 50% (miniCHOP: cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and 1 mg vincristine on day 1 of each cycle, and prednisone 40 mg/m² on days 1-5) plus an anti–CD-20 antibody (rituximab 375 mg/m² or ofatumumab 1,000 mg). The first of these studies obtained CR rate of 62% and 2-year OS of 59% with low toxicities. The second study achieved slightly better results, according to the reviewers, who suggested the difference was possibly because of a prephase treatment and/or the use of ofatumumab.

One study group developed a simple prognostic model based on multivariate analysis of 108 patients aged 80 years and older treated in their study with R-CHOP at full (48%) or reduced dose (51%). Patients with at least two out of three risk factors (age > 85 years, revised International Prognostic Index score 3-5 and CIRS > 5) had worse survival than did those with 0-1 risk factors, with a median OS of 12 months vs. 45 months, P = .001, respectively).

“All these studies results favor the tailored treatment approach,” the reviewers stated. “More prospective studies are still needed to demonstrate and validate the adequate tools for the selection of patients and their optimal treatment. They would provide the grounds for clinical therapeutic decision, aiming for tailored treatment and fulfilling best individual expectations and outcome,” they concluded.

The authors reported that they received no research funds for the study and that they had no disclosures.
 

[email protected]

A dose-adjusted R-CHOP may be the best treatment for elderly patients with diffuse large beta-cell lymphoma (DLBCL), according to a review of 38 studies that examined this aged population.

Nephron/Wikimedia Commons/CC BY-SA 3.0

In addition, treatment choices based on new tools such as the Comprehensive Geriatric Assessment appeared to provide useful guidance based on the comorbidities and frailty index of this group of patients, according to Alda Tavares, MD, of Hospital Pedro Hispano, Matosinhos (Portugal) Local Health Unit, and Ilídia Moreira, MD, of the Portuguese Institute of Oncology of Porto.
 

Study characteristics

Of the 38 studies assessed, 13 were retrospective and 25 were phase II/III clinical trials. Most of these studies investigated the efficacy of dose-adjusted R-CHOP regimen, according to the review published online in Critical Reviews in Oncology/Hematology.

Alternative therapeutic drugs as well as the use of geriatric assessment were also investigated.

In terms of the elderly populations assessed, 11 out of 38 studies included at least 30 patients over age 80 years, although 11 other studies did not specify the number of patients older than 80 years. Eight of the studies included exclusively patients aged 80 years and over. Three of these studies were phase II trials.

Only six of the clinical trials required a geriatric assessment tool for inclusion criteria or therapeutic regime choice, using the Cumulative Illness Rating Scale–Geriatric (CIRS-G), the performance in activities of daily living (ADL) and/or instrumental activities of daily living (IADL) tools.

Most of the studies investigated the efficacy of R-CHOP regimen at different doses and variations, with 11 studies using alternative anthracycline in place of doxorubicin.
 

MiniCHOP mattered

Elderly patients over 80 years achieved complete response (CR) rates from 37.2% to 66.7% and 2-year overall survival (OS) from 31.9% to 64.7% across the studies reviewed. Overall, for fit patients aged 80 and over, the strongest evidence favored the use of an R-miniCHOP regimen, according to the authors.

In the 25 studies with treatment based on R-CHOP/modified R-CHOP or immunochemotherapy with an alternative anthracycline, the CR rate was below 50% in three studies and over 60% in the majority. Higher CR rates of 71%-88.9% were achieved in eight studies.

For patients over 80 years, the strongest evidence favored rituximab/ofatumumab-miniCHOP, based on two studies. In both studies, patients over 80 years old, without significant comorbidities, received CHOP regime with a dose reduction of about 50% (miniCHOP: cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and 1 mg vincristine on day 1 of each cycle, and prednisone 40 mg/m² on days 1-5) plus an anti–CD-20 antibody (rituximab 375 mg/m² or ofatumumab 1,000 mg). The first of these studies obtained CR rate of 62% and 2-year OS of 59% with low toxicities. The second study achieved slightly better results, according to the reviewers, who suggested the difference was possibly because of a prephase treatment and/or the use of ofatumumab.

One study group developed a simple prognostic model based on multivariate analysis of 108 patients aged 80 years and older treated in their study with R-CHOP at full (48%) or reduced dose (51%). Patients with at least two out of three risk factors (age > 85 years, revised International Prognostic Index score 3-5 and CIRS > 5) had worse survival than did those with 0-1 risk factors, with a median OS of 12 months vs. 45 months, P = .001, respectively).

“All these studies results favor the tailored treatment approach,” the reviewers stated. “More prospective studies are still needed to demonstrate and validate the adequate tools for the selection of patients and their optimal treatment. They would provide the grounds for clinical therapeutic decision, aiming for tailored treatment and fulfilling best individual expectations and outcome,” they concluded.

The authors reported that they received no research funds for the study and that they had no disclosures.
 

[email protected]

Veterans have a higher prevalence of type 2 diabetes mellitus (T2DM) when compared with their civilian counterparts with an overall prevalence rate of 25%.¹ This higher prevalence is similar to other major chronic health conditions, including heart disease and arthritis, with additional costs for disease self-management.² Psychological and behavioral change strategies are a principal means of limiting the severity and even restoring function once T2DM is diagnosed.³ More broadly, there is mounting evidence that addressing distress and behavior change are important across many conditions, particularly T2DM.⁴ Therefore, the US Department of Veterans Affairs (VA) has established patient education and multidisciplinary interventions to optimize engagement in T2DM self-management and health behavior change.⁵

Traditional T2DM education programs aim to meet the American Diabetes Association (ADA) standards of medical care and include a T2DM educator and other allied health professionals. ADA Standard 1.2 emphasizes “productive interactions between a prepared, proactive care team and an informed, activated patient.”⁶ Thus, to attain ADA accreditation, educational programs require instructors to teach about T2DM while engaging patients to help them set and achieve recommended changes. The requirements emphasize setting specific goals, (ie, eating wisely, being physically active, monitoring blood sugars or taking medications). The care team also helps to identify barriers, and at a required follow-up class, patients evaluate how well they met goals and make modifications if needed. The impact of traditional patient education programs to improve glycemic levels is well established.⁷ Importantly, veterans with comorbid mental health conditions may not experience the same beneficial outcomes if or when they participate in traditional diabetes or self-management programs.^8,9 Veterans with T2DM may be particularly vulnerable to chronic stress and effects of comorbid mental health diagnoses.¹⁰ Furthermore, when individuals experience T2DM-related distress, associations with poor health outcomes, including elevated hemoglobin A_1c (HbA_1c), are observed independent of depression.¹¹

Health psychology services integrate into medical settings and strive to reach veterans who may not engage in traditional mental health clinical offerings.¹² These collaborative interventions focus less on diagnostic or screening procedures and more on a patient’s understanding of illness and ability and willingness to carry out treatment regimens. Given the significant roles of distress and co-occurring conditions, health psychology services further aim to provide psychoeducation about stress management in order to explore and enhance motivation for making a wide range of health behavior changes.

The purpose of this study was to evaluate baseline and follow-up HbA_1c, weight, and psychosocial measures, namely, health-related self-efficacy and T2DM-related distress among a small sample that engaged in integrated health psychology services. The focus of this evidence-based psychotherapy service was to improve T2DM self-care and physical health. The participants were offered cognitive and behavioral strategies for setting and meeting personalized T2DM self-management goals. Importantly, motivational interviewing was used throughout to adapt to the participants’ preferences and needs as well as to maintain engagement.

Methods

Primary care providers referred veterans with T2DM to the Health Psychology service at VA Ann Arbor Healthcare System (VAAAHS). A T2DM diagnosis was verified through electronic health record review. Most common referrals included addressing coping with chronic illness and improving glycemic levels. Veterans were invited to participate in a program evaluation project to monitor health-related changes. All participants provided written informed consent and did not receive incentive or payment for participating. The VAAAHS Institutional Review Board reviewed and approved this study.

Intervention

Veterans met individually with a health psychologist or health psychology trainee to create personalized health and behavioral goals for improving T2DM self-management, overall health, and psychological well-being. This intervention included motivational interviewing, SMART (specific, measurable, action-oriented, realistic, timely) goal setting, behavioral activation, acceptance of T2DM-related physical changes, problem-solving therapy, challenging maladaptive disease-related cognitions, and incorporating values to help find motivation for change. Interventionists took a flexible approach and met in-person in primary or specialty care clinics, over the phone, and through telehealth 1 to 4 times a month, meeting participant preferences, with sessions typically ranging from 45 to 60 minutes. The goal of the study was to disseminate and implement evidence-based behavioral change strategies into a multidisciplinary team format without excluding veterans who would benefit from receiving active treatment. Due to this translational approach, a control group was not included for comparison.

Data Collection

Participants completed study measures at the beginning and end of the T2DM-focused intervention sessions. Demographic variables collected included age, sex, race/ethnicity, highest educational attainment, and whether a veteran was prescribed insulin, service connected for T2DM, concurrent enrollment in other educational programs, and time since T2DM diagnosis. Measures were selected based on their relevance to T2DM psychosocial care and diabetes health outcomes.¹³

Body mass index, low-density lipoprotein cholesterol, blood pressure (BP), HbA_1c within 3 months of the pre- and postmeasures were collected by reviewing medical records. T2DM complications were collected by self-report, and comorbid physical and mental health conditions were collected by review of the most recent primary care note. The Diabetes Empowerment Scale-Short Form (DES-SF) is a well-validated measure that was used to measure T2DM-related psychosocial self-efficacy.¹⁴ Scores ranged from 8 to 40 with higher scores indicating higher diabetes T2DM empowerment. The Patient Health Questionnaire 9-item (PHQ-9) was used to assess the frequency of somatic (fatigue, appetite, psychomotor) and cognitive symptoms (anhedonia, low mood) of depression over the past 2 weeks.¹⁵ The Generalized Anxiety Disorder 7-item (GAD-7) was used to assess the frequency of common anxiety symptoms, including feelings of worry, difficulty controlling worry, and trouble relaxing.¹⁶ Veterans were also asked to rate their general health on a 5-point Likert scale. Self-rated health is a well-established indicator of disability and risk of future T2DM complications in older adults.^17,18 The Diabetes Distress Scale (DDS) was used to measure emotional burden, physician-related distress, regimen-related distress, and T2DM-related interpersonal distress.¹⁹ Scores > 2.0 suggest clinical significant diabetes distress.²⁰ Medication questionnaires were adapted from Wilson and colleagues, 2013.²¹

Statistical Analyses

Descriptive statistics, including mean and standard deviation (SD) or frequency distributions, as appropriate, were used to characterize the sample. For pre- and postintervention within-group comparisons, a paired samples Student t test analysis was used to evaluate baseline and follow-up measures for statistically significant differences between continuous variables; scores also were evaluated for clinically meaningful change.

Results

This sample (N = 13) of older adults was predominately male, white, with HbA_1c > 7.0, and prescribed insulin (Table). On average, participants were at higher risk for future complications due to high BP, hyperlipidemia, and BMI > 30.0. Regarding participation, veterans were seen for an average of 7.8 sessions (range, 4-13) with 46% service connected for T2DM. Of note, 4 veterans received other T2DM-specific self-management support within the same year of their participation with health psychology, such as attending a T2DM education class or T2DM shared medical appointment.²² Reliability in the current sample for the DES-SF was high (Cronbach α = 0.90), PHQ-9 was good (Cronbach α = 0.81), and GAD-7 was very good (Cronbach α = 0.86).

Among the 13 older adults, the most common T2DM-related complications included peripheral neuropathy (n = 7), heart pain or heart attack (n = 5), and retinopathy (n = 4). Recent primary care notes showed a mean (SD) 7 (2.2) comorbid chronic medical conditions with a high prevalence of cardiometabolic illnesses including hypertension, hyperlipidemia, obstructive sleep apnea, and a diagnosis of chronic pain. Eleven veterans were diagnosed with a mental health condition, including bipolar disorder, depression, anxiety, trauma-related disorder, and sleep disorders. Veterans reported high T2DM emotional distress (mean [SD] 3.1 [1.2]), moderate regimen-related distress (mean [SD] 2.9 [1.1]), and moderate total T2DM distress (mean [SD] 2.4 [0.7]). Physician distress (mean [SD] 1.3 [0.55]) and interpersonal T2DM distress (mean [SD] 1.6 [0.9]) subscales indicated little to no distress. The sample reported mild symptoms of depression (PHQ-9 mean [SD] 8.8 [4.6]); mild symptoms of anxiety (GAD-7 mean, 7.1; SD, 4.4), and Diabetes Empowerment (mean, 31.2; SD, 6.0). Participants described missing an average of 2.4 days within the past 30 days of their T2DM oral medications.

Twelve veterans (92.7%) completed the Follow-up questionnaires. The Figure illustrates statistically significant changes in patient-reported outcomes between baseline and follow-up. Clinically meaningful reductions were shown in total T2DM distress (t₁₁ = 5.03, P < .01), T2DM emotional burden (t₁₁ = 4.83, P = .01), and T2DM regimen-related distress (t₁₁ = 5.14, P < .01). There was a significant increase in T2DM self-efficacy (t₁₁ = 0.32, P = .008) as well. A statistically significant reduction was seen in depressive symptoms (t₁₁ = 2.22, P = .048). While HbA_1c fell by .56 percentage points (standard error of the mean [SEM], 31; P = .10), this change was not statistically significant. Follow-up analyses also showed a clinically, though not statistically, significant reduction in weight loss by 6.9 lb. (SEM, 3.8; P = .20), and reductions of generalized anxiety by 1.2 points (SEM, 1.4; P = .42). Pre- and postanalyses did not show differences among self-rated health, physician-related burden, interpersonal-related burden, and indicators of medication taking behavior.

Discussion

This observational study evaluated change among patient-reported T2DM-specific and general distress measures and health outcomes among a small sample of veterans at VAAAHS medical center that engaged in an episode of individual care with health psychology. Statistically significant decreases were observed in T2DM-related distress. Noteworthy, these decreases were observed for the emotional burden and regimen subscales, and each of these was clinically meaningful, falling below a score of 2.0 on the T2DM-specific scale. This is important given that T2DM distress may interfere with the ability to understand and find motivation for engaging in health behavior change. Incorporating stress management interventions into interdisciplinary health programs has been demonstrated to improve not only levels of distress, but also other health outcomes, such as health related quality of life and cardiac events in heart disease.²³ Thus, behavioral health interventions that incorporate cognitive-behavioral strategies to enhance distress-specific coping may prove important to include among individuals with T2DM.

Reductions in T2DM-related distress also converged with increases observed in the T2DM empowerment scale. These significant improvements in perceived ability suggest increased self-efficacy and willingness to follow a daily T2DM regimen. This finding aligns with the social support literature that demonstrates how instrumental and other aspects of autonomous social support mediate improvements in health-related outcomes and reduced T2DM distress.^24,25 Health psychology interventions strive to both provide social support as well as enhance participants’ perceptions and use of existing support as a cognitive-behavioral strategy. Adding in assessments of social support could shed light on such mediating factors.

The ADA standards of care encourage heath care providers to engage patients in conversations in order to better understand the barriers of T2DM self-care.¹³ How to best support patients within a primary care multidisciplinary team remains unclear.²⁶ T2DM distress and negative reactions to T2DM, including symptoms of anxiety and depression, are common and may require specific referral to a mental health provider if repeated attempts at T2DM education do not improve self-management and illness biomarkers.²⁷ Thus, integrating these providers and services within the medical setting aims to reach more veterans and potentially meet these standards of care. With our health psychology integrated services, clinically significant decreases in anxiety and statistically significant decreases in depressive symptoms were observed that approached “mild to no” symptoms. Although this was not measured formally, the veterans were not engaging in mental health specialty care historically or during the year of the health psychology intervention. This suggests that health psychology services helped bridge the gap and address these psychosocial needs within the small sample.

For clinical measures, modest decreases were observed for HbA_1c and weight. The authors recognize that these changes may not be optimal in terms of health status. A review of the specific patient-centered goals may illuminate this finding. For example, 1 participant had a goal to consume fewer sugary beverages and achieved this behavior change. Yet this change alone may not equate to actual weight loss or a lower HbA_1c. Furthermore, in the context of T2DM-related distress, maintaining current weight and/or blood sugar levels may be a more realistic goal. An evaluation of the specific patient-oriented action goals and observed progress may be important outcomes to include in larger studies. Moreover, while not significant, the average HbA_1c decrease of about 1% is comparable with traditional T2DM education and should be considered in light of the sample’s significant mental health comorbidities. While landmark intensive glucose control trials illustrate significant benefits in reductions of hyperglycemia and nonfatal cardiovascular disease, these reductions are associated with an approximate 2-fold risk of hypoglycemia.^28-30 Thus, the focus on improved glycemic control has been criticized as lacking meaning to patients in contrast to preventing T2DM complications and persevering quality of life.³¹

Limitations and Future Directions

Noted limitations include small sample size, the range of time, and a broad number of sessions given that the intervention was tailored to each veteran. Conclusions drawn from a small sample may be influenced by individual outliers. Given co-occurring conditions and moderate levels of distress, all participants may benefit from additional support resources.

In addition to these considerations, having a comparison group could further strengthen the study as part of an observational database. A between-group comparison could help clinicians better understand what the interventions offer as well as some individual factors that relate to participation and success with behavior change. In the future, studies with a priori hypotheses could also consider the trajectories of weight and blood sugar levels for extended periods; for example, 6 months before the intervention and 6 months following.³² Given the complexity of comorbid mental health and chronic medical conditions in this sample, it also may be important to measure the relationships between chronic physical symptoms as an additional barrier for veterans to make health behavior changes.

Conclusions

The authors believe that the health psychology interventions offered important support and motivation for engagement in health behavior change that led to reduced distress in this patient group. It remains a challenge to engage veterans with psychiatric conditions in mental health care, and simultaneously for health care systems that strive to reduce costs and complications associated with chronic illness management.³³ Aligned with these broader health care goals, the ADA aims to reduce complications and cost and improve outcomes for T2DM with guidelines requiring mental and behavioral health interventions. The authors believe that health psychology interventions are a personalized and feasible bridge to address engagement, illness-related distress while improving patient-satisfaction and T2DM self-management.

Acknowledgments

The authors thank the veterans who participated in the observational study. We thank the VA Ann Arbor Healthcare System Institutional Review Board. For instrumental support for health psychology integrated services, we acknowledge Adam Tremblay, MD, Primary Care Chief, and R.J. Schildhouse, MD, Acting Associate Chief of Staff, Ambulatory Care. The work was supported by the Ambulatory Care Service at the VA Ann Arbor Healthcare System and the VA Office of Academic Affiliations.

Veterans have a higher prevalence of type 2 diabetes mellitus (T2DM) when compared with their civilian counterparts with an overall prevalence rate of 25%.¹ This higher prevalence is similar to other major chronic health conditions, including heart disease and arthritis, with additional costs for disease self-management.² Psychological and behavioral change strategies are a principal means of limiting the severity and even restoring function once T2DM is diagnosed.³ More broadly, there is mounting evidence that addressing distress and behavior change are important across many conditions, particularly T2DM.⁴ Therefore, the US Department of Veterans Affairs (VA) has established patient education and multidisciplinary interventions to optimize engagement in T2DM self-management and health behavior change.⁵

Traditional T2DM education programs aim to meet the American Diabetes Association (ADA) standards of medical care and include a T2DM educator and other allied health professionals. ADA Standard 1.2 emphasizes “productive interactions between a prepared, proactive care team and an informed, activated patient.”⁶ Thus, to attain ADA accreditation, educational programs require instructors to teach about T2DM while engaging patients to help them set and achieve recommended changes. The requirements emphasize setting specific goals, (ie, eating wisely, being physically active, monitoring blood sugars or taking medications). The care team also helps to identify barriers, and at a required follow-up class, patients evaluate how well they met goals and make modifications if needed. The impact of traditional patient education programs to improve glycemic levels is well established.⁷ Importantly, veterans with comorbid mental health conditions may not experience the same beneficial outcomes if or when they participate in traditional diabetes or self-management programs.^8,9 Veterans with T2DM may be particularly vulnerable to chronic stress and effects of comorbid mental health diagnoses.¹⁰ Furthermore, when individuals experience T2DM-related distress, associations with poor health outcomes, including elevated hemoglobin A_1c (HbA_1c), are observed independent of depression.¹¹

Health psychology services integrate into medical settings and strive to reach veterans who may not engage in traditional mental health clinical offerings.¹² These collaborative interventions focus less on diagnostic or screening procedures and more on a patient’s understanding of illness and ability and willingness to carry out treatment regimens. Given the significant roles of distress and co-occurring conditions, health psychology services further aim to provide psychoeducation about stress management in order to explore and enhance motivation for making a wide range of health behavior changes.

The purpose of this study was to evaluate baseline and follow-up HbA_1c, weight, and psychosocial measures, namely, health-related self-efficacy and T2DM-related distress among a small sample that engaged in integrated health psychology services. The focus of this evidence-based psychotherapy service was to improve T2DM self-care and physical health. The participants were offered cognitive and behavioral strategies for setting and meeting personalized T2DM self-management goals. Importantly, motivational interviewing was used throughout to adapt to the participants’ preferences and needs as well as to maintain engagement.

Methods

Primary care providers referred veterans with T2DM to the Health Psychology service at VA Ann Arbor Healthcare System (VAAAHS). A T2DM diagnosis was verified through electronic health record review. Most common referrals included addressing coping with chronic illness and improving glycemic levels. Veterans were invited to participate in a program evaluation project to monitor health-related changes. All participants provided written informed consent and did not receive incentive or payment for participating. The VAAAHS Institutional Review Board reviewed and approved this study.

Intervention

Veterans met individually with a health psychologist or health psychology trainee to create personalized health and behavioral goals for improving T2DM self-management, overall health, and psychological well-being. This intervention included motivational interviewing, SMART (specific, measurable, action-oriented, realistic, timely) goal setting, behavioral activation, acceptance of T2DM-related physical changes, problem-solving therapy, challenging maladaptive disease-related cognitions, and incorporating values to help find motivation for change. Interventionists took a flexible approach and met in-person in primary or specialty care clinics, over the phone, and through telehealth 1 to 4 times a month, meeting participant preferences, with sessions typically ranging from 45 to 60 minutes. The goal of the study was to disseminate and implement evidence-based behavioral change strategies into a multidisciplinary team format without excluding veterans who would benefit from receiving active treatment. Due to this translational approach, a control group was not included for comparison.

Data Collection

Participants completed study measures at the beginning and end of the T2DM-focused intervention sessions. Demographic variables collected included age, sex, race/ethnicity, highest educational attainment, and whether a veteran was prescribed insulin, service connected for T2DM, concurrent enrollment in other educational programs, and time since T2DM diagnosis. Measures were selected based on their relevance to T2DM psychosocial care and diabetes health outcomes.¹³

Body mass index, low-density lipoprotein cholesterol, blood pressure (BP), HbA_1c within 3 months of the pre- and postmeasures were collected by reviewing medical records. T2DM complications were collected by self-report, and comorbid physical and mental health conditions were collected by review of the most recent primary care note. The Diabetes Empowerment Scale-Short Form (DES-SF) is a well-validated measure that was used to measure T2DM-related psychosocial self-efficacy.¹⁴ Scores ranged from 8 to 40 with higher scores indicating higher diabetes T2DM empowerment. The Patient Health Questionnaire 9-item (PHQ-9) was used to assess the frequency of somatic (fatigue, appetite, psychomotor) and cognitive symptoms (anhedonia, low mood) of depression over the past 2 weeks.¹⁵ The Generalized Anxiety Disorder 7-item (GAD-7) was used to assess the frequency of common anxiety symptoms, including feelings of worry, difficulty controlling worry, and trouble relaxing.¹⁶ Veterans were also asked to rate their general health on a 5-point Likert scale. Self-rated health is a well-established indicator of disability and risk of future T2DM complications in older adults.^17,18 The Diabetes Distress Scale (DDS) was used to measure emotional burden, physician-related distress, regimen-related distress, and T2DM-related interpersonal distress.¹⁹ Scores > 2.0 suggest clinical significant diabetes distress.²⁰ Medication questionnaires were adapted from Wilson and colleagues, 2013.²¹

Statistical Analyses

Descriptive statistics, including mean and standard deviation (SD) or frequency distributions, as appropriate, were used to characterize the sample. For pre- and postintervention within-group comparisons, a paired samples Student t test analysis was used to evaluate baseline and follow-up measures for statistically significant differences between continuous variables; scores also were evaluated for clinically meaningful change.

Results

This sample (N = 13) of older adults was predominately male, white, with HbA_1c > 7.0, and prescribed insulin (Table). On average, participants were at higher risk for future complications due to high BP, hyperlipidemia, and BMI > 30.0. Regarding participation, veterans were seen for an average of 7.8 sessions (range, 4-13) with 46% service connected for T2DM. Of note, 4 veterans received other T2DM-specific self-management support within the same year of their participation with health psychology, such as attending a T2DM education class or T2DM shared medical appointment.²² Reliability in the current sample for the DES-SF was high (Cronbach α = 0.90), PHQ-9 was good (Cronbach α = 0.81), and GAD-7 was very good (Cronbach α = 0.86).

Among the 13 older adults, the most common T2DM-related complications included peripheral neuropathy (n = 7), heart pain or heart attack (n = 5), and retinopathy (n = 4). Recent primary care notes showed a mean (SD) 7 (2.2) comorbid chronic medical conditions with a high prevalence of cardiometabolic illnesses including hypertension, hyperlipidemia, obstructive sleep apnea, and a diagnosis of chronic pain. Eleven veterans were diagnosed with a mental health condition, including bipolar disorder, depression, anxiety, trauma-related disorder, and sleep disorders. Veterans reported high T2DM emotional distress (mean [SD] 3.1 [1.2]), moderate regimen-related distress (mean [SD] 2.9 [1.1]), and moderate total T2DM distress (mean [SD] 2.4 [0.7]). Physician distress (mean [SD] 1.3 [0.55]) and interpersonal T2DM distress (mean [SD] 1.6 [0.9]) subscales indicated little to no distress. The sample reported mild symptoms of depression (PHQ-9 mean [SD] 8.8 [4.6]); mild symptoms of anxiety (GAD-7 mean, 7.1; SD, 4.4), and Diabetes Empowerment (mean, 31.2; SD, 6.0). Participants described missing an average of 2.4 days within the past 30 days of their T2DM oral medications.

Twelve veterans (92.7%) completed the Follow-up questionnaires. The Figure illustrates statistically significant changes in patient-reported outcomes between baseline and follow-up. Clinically meaningful reductions were shown in total T2DM distress (t₁₁ = 5.03, P < .01), T2DM emotional burden (t₁₁ = 4.83, P = .01), and T2DM regimen-related distress (t₁₁ = 5.14, P < .01). There was a significant increase in T2DM self-efficacy (t₁₁ = 0.32, P = .008) as well. A statistically significant reduction was seen in depressive symptoms (t₁₁ = 2.22, P = .048). While HbA_1c fell by .56 percentage points (standard error of the mean [SEM], 31; P = .10), this change was not statistically significant. Follow-up analyses also showed a clinically, though not statistically, significant reduction in weight loss by 6.9 lb. (SEM, 3.8; P = .20), and reductions of generalized anxiety by 1.2 points (SEM, 1.4; P = .42). Pre- and postanalyses did not show differences among self-rated health, physician-related burden, interpersonal-related burden, and indicators of medication taking behavior.

Discussion

This observational study evaluated change among patient-reported T2DM-specific and general distress measures and health outcomes among a small sample of veterans at VAAAHS medical center that engaged in an episode of individual care with health psychology. Statistically significant decreases were observed in T2DM-related distress. Noteworthy, these decreases were observed for the emotional burden and regimen subscales, and each of these was clinically meaningful, falling below a score of 2.0 on the T2DM-specific scale. This is important given that T2DM distress may interfere with the ability to understand and find motivation for engaging in health behavior change. Incorporating stress management interventions into interdisciplinary health programs has been demonstrated to improve not only levels of distress, but also other health outcomes, such as health related quality of life and cardiac events in heart disease.²³ Thus, behavioral health interventions that incorporate cognitive-behavioral strategies to enhance distress-specific coping may prove important to include among individuals with T2DM.

Reductions in T2DM-related distress also converged with increases observed in the T2DM empowerment scale. These significant improvements in perceived ability suggest increased self-efficacy and willingness to follow a daily T2DM regimen. This finding aligns with the social support literature that demonstrates how instrumental and other aspects of autonomous social support mediate improvements in health-related outcomes and reduced T2DM distress.^24,25 Health psychology interventions strive to both provide social support as well as enhance participants’ perceptions and use of existing support as a cognitive-behavioral strategy. Adding in assessments of social support could shed light on such mediating factors.

The ADA standards of care encourage heath care providers to engage patients in conversations in order to better understand the barriers of T2DM self-care.¹³ How to best support patients within a primary care multidisciplinary team remains unclear.²⁶ T2DM distress and negative reactions to T2DM, including symptoms of anxiety and depression, are common and may require specific referral to a mental health provider if repeated attempts at T2DM education do not improve self-management and illness biomarkers.²⁷ Thus, integrating these providers and services within the medical setting aims to reach more veterans and potentially meet these standards of care. With our health psychology integrated services, clinically significant decreases in anxiety and statistically significant decreases in depressive symptoms were observed that approached “mild to no” symptoms. Although this was not measured formally, the veterans were not engaging in mental health specialty care historically or during the year of the health psychology intervention. This suggests that health psychology services helped bridge the gap and address these psychosocial needs within the small sample.

For clinical measures, modest decreases were observed for HbA_1c and weight. The authors recognize that these changes may not be optimal in terms of health status. A review of the specific patient-centered goals may illuminate this finding. For example, 1 participant had a goal to consume fewer sugary beverages and achieved this behavior change. Yet this change alone may not equate to actual weight loss or a lower HbA_1c. Furthermore, in the context of T2DM-related distress, maintaining current weight and/or blood sugar levels may be a more realistic goal. An evaluation of the specific patient-oriented action goals and observed progress may be important outcomes to include in larger studies. Moreover, while not significant, the average HbA_1c decrease of about 1% is comparable with traditional T2DM education and should be considered in light of the sample’s significant mental health comorbidities. While landmark intensive glucose control trials illustrate significant benefits in reductions of hyperglycemia and nonfatal cardiovascular disease, these reductions are associated with an approximate 2-fold risk of hypoglycemia.^28-30 Thus, the focus on improved glycemic control has been criticized as lacking meaning to patients in contrast to preventing T2DM complications and persevering quality of life.³¹

Limitations and Future Directions

Noted limitations include small sample size, the range of time, and a broad number of sessions given that the intervention was tailored to each veteran. Conclusions drawn from a small sample may be influenced by individual outliers. Given co-occurring conditions and moderate levels of distress, all participants may benefit from additional support resources.

In addition to these considerations, having a comparison group could further strengthen the study as part of an observational database. A between-group comparison could help clinicians better understand what the interventions offer as well as some individual factors that relate to participation and success with behavior change. In the future, studies with a priori hypotheses could also consider the trajectories of weight and blood sugar levels for extended periods; for example, 6 months before the intervention and 6 months following.³² Given the complexity of comorbid mental health and chronic medical conditions in this sample, it also may be important to measure the relationships between chronic physical symptoms as an additional barrier for veterans to make health behavior changes.

Conclusions

The authors believe that the health psychology interventions offered important support and motivation for engagement in health behavior change that led to reduced distress in this patient group. It remains a challenge to engage veterans with psychiatric conditions in mental health care, and simultaneously for health care systems that strive to reduce costs and complications associated with chronic illness management.³³ Aligned with these broader health care goals, the ADA aims to reduce complications and cost and improve outcomes for T2DM with guidelines requiring mental and behavioral health interventions. The authors believe that health psychology interventions are a personalized and feasible bridge to address engagement, illness-related distress while improving patient-satisfaction and T2DM self-management.

Acknowledgments

The authors thank the veterans who participated in the observational study. We thank the VA Ann Arbor Healthcare System Institutional Review Board. For instrumental support for health psychology integrated services, we acknowledge Adam Tremblay, MD, Primary Care Chief, and R.J. Schildhouse, MD, Acting Associate Chief of Staff, Ambulatory Care. The work was supported by the Ambulatory Care Service at the VA Ann Arbor Healthcare System and the VA Office of Academic Affiliations.

Veterans have a higher prevalence of type 2 diabetes mellitus (T2DM) when compared with their civilian counterparts with an overall prevalence rate of 25%.¹ This higher prevalence is similar to other major chronic health conditions, including heart disease and arthritis, with additional costs for disease self-management.² Psychological and behavioral change strategies are a principal means of limiting the severity and even restoring function once T2DM is diagnosed.³ More broadly, there is mounting evidence that addressing distress and behavior change are important across many conditions, particularly T2DM.⁴ Therefore, the US Department of Veterans Affairs (VA) has established patient education and multidisciplinary interventions to optimize engagement in T2DM self-management and health behavior change.⁵

Traditional T2DM education programs aim to meet the American Diabetes Association (ADA) standards of medical care and include a T2DM educator and other allied health professionals. ADA Standard 1.2 emphasizes “productive interactions between a prepared, proactive care team and an informed, activated patient.”⁶ Thus, to attain ADA accreditation, educational programs require instructors to teach about T2DM while engaging patients to help them set and achieve recommended changes. The requirements emphasize setting specific goals, (ie, eating wisely, being physically active, monitoring blood sugars or taking medications). The care team also helps to identify barriers, and at a required follow-up class, patients evaluate how well they met goals and make modifications if needed. The impact of traditional patient education programs to improve glycemic levels is well established.⁷ Importantly, veterans with comorbid mental health conditions may not experience the same beneficial outcomes if or when they participate in traditional diabetes or self-management programs.^8,9 Veterans with T2DM may be particularly vulnerable to chronic stress and effects of comorbid mental health diagnoses.¹⁰ Furthermore, when individuals experience T2DM-related distress, associations with poor health outcomes, including elevated hemoglobin A_1c (HbA_1c), are observed independent of depression.¹¹

Health psychology services integrate into medical settings and strive to reach veterans who may not engage in traditional mental health clinical offerings.¹² These collaborative interventions focus less on diagnostic or screening procedures and more on a patient’s understanding of illness and ability and willingness to carry out treatment regimens. Given the significant roles of distress and co-occurring conditions, health psychology services further aim to provide psychoeducation about stress management in order to explore and enhance motivation for making a wide range of health behavior changes.

The purpose of this study was to evaluate baseline and follow-up HbA_1c, weight, and psychosocial measures, namely, health-related self-efficacy and T2DM-related distress among a small sample that engaged in integrated health psychology services. The focus of this evidence-based psychotherapy service was to improve T2DM self-care and physical health. The participants were offered cognitive and behavioral strategies for setting and meeting personalized T2DM self-management goals. Importantly, motivational interviewing was used throughout to adapt to the participants’ preferences and needs as well as to maintain engagement.

Methods

Primary care providers referred veterans with T2DM to the Health Psychology service at VA Ann Arbor Healthcare System (VAAAHS). A T2DM diagnosis was verified through electronic health record review. Most common referrals included addressing coping with chronic illness and improving glycemic levels. Veterans were invited to participate in a program evaluation project to monitor health-related changes. All participants provided written informed consent and did not receive incentive or payment for participating. The VAAAHS Institutional Review Board reviewed and approved this study.

Intervention

Veterans met individually with a health psychologist or health psychology trainee to create personalized health and behavioral goals for improving T2DM self-management, overall health, and psychological well-being. This intervention included motivational interviewing, SMART (specific, measurable, action-oriented, realistic, timely) goal setting, behavioral activation, acceptance of T2DM-related physical changes, problem-solving therapy, challenging maladaptive disease-related cognitions, and incorporating values to help find motivation for change. Interventionists took a flexible approach and met in-person in primary or specialty care clinics, over the phone, and through telehealth 1 to 4 times a month, meeting participant preferences, with sessions typically ranging from 45 to 60 minutes. The goal of the study was to disseminate and implement evidence-based behavioral change strategies into a multidisciplinary team format without excluding veterans who would benefit from receiving active treatment. Due to this translational approach, a control group was not included for comparison.

Data Collection

Participants completed study measures at the beginning and end of the T2DM-focused intervention sessions. Demographic variables collected included age, sex, race/ethnicity, highest educational attainment, and whether a veteran was prescribed insulin, service connected for T2DM, concurrent enrollment in other educational programs, and time since T2DM diagnosis. Measures were selected based on their relevance to T2DM psychosocial care and diabetes health outcomes.¹³

Body mass index, low-density lipoprotein cholesterol, blood pressure (BP), HbA_1c within 3 months of the pre- and postmeasures were collected by reviewing medical records. T2DM complications were collected by self-report, and comorbid physical and mental health conditions were collected by review of the most recent primary care note. The Diabetes Empowerment Scale-Short Form (DES-SF) is a well-validated measure that was used to measure T2DM-related psychosocial self-efficacy.¹⁴ Scores ranged from 8 to 40 with higher scores indicating higher diabetes T2DM empowerment. The Patient Health Questionnaire 9-item (PHQ-9) was used to assess the frequency of somatic (fatigue, appetite, psychomotor) and cognitive symptoms (anhedonia, low mood) of depression over the past 2 weeks.¹⁵ The Generalized Anxiety Disorder 7-item (GAD-7) was used to assess the frequency of common anxiety symptoms, including feelings of worry, difficulty controlling worry, and trouble relaxing.¹⁶ Veterans were also asked to rate their general health on a 5-point Likert scale. Self-rated health is a well-established indicator of disability and risk of future T2DM complications in older adults.^17,18 The Diabetes Distress Scale (DDS) was used to measure emotional burden, physician-related distress, regimen-related distress, and T2DM-related interpersonal distress.¹⁹ Scores > 2.0 suggest clinical significant diabetes distress.²⁰ Medication questionnaires were adapted from Wilson and colleagues, 2013.²¹

Statistical Analyses

Descriptive statistics, including mean and standard deviation (SD) or frequency distributions, as appropriate, were used to characterize the sample. For pre- and postintervention within-group comparisons, a paired samples Student t test analysis was used to evaluate baseline and follow-up measures for statistically significant differences between continuous variables; scores also were evaluated for clinically meaningful change.

Results

This sample (N = 13) of older adults was predominately male, white, with HbA_1c > 7.0, and prescribed insulin (Table). On average, participants were at higher risk for future complications due to high BP, hyperlipidemia, and BMI > 30.0. Regarding participation, veterans were seen for an average of 7.8 sessions (range, 4-13) with 46% service connected for T2DM. Of note, 4 veterans received other T2DM-specific self-management support within the same year of their participation with health psychology, such as attending a T2DM education class or T2DM shared medical appointment.²² Reliability in the current sample for the DES-SF was high (Cronbach α = 0.90), PHQ-9 was good (Cronbach α = 0.81), and GAD-7 was very good (Cronbach α = 0.86).

Among the 13 older adults, the most common T2DM-related complications included peripheral neuropathy (n = 7), heart pain or heart attack (n = 5), and retinopathy (n = 4). Recent primary care notes showed a mean (SD) 7 (2.2) comorbid chronic medical conditions with a high prevalence of cardiometabolic illnesses including hypertension, hyperlipidemia, obstructive sleep apnea, and a diagnosis of chronic pain. Eleven veterans were diagnosed with a mental health condition, including bipolar disorder, depression, anxiety, trauma-related disorder, and sleep disorders. Veterans reported high T2DM emotional distress (mean [SD] 3.1 [1.2]), moderate regimen-related distress (mean [SD] 2.9 [1.1]), and moderate total T2DM distress (mean [SD] 2.4 [0.7]). Physician distress (mean [SD] 1.3 [0.55]) and interpersonal T2DM distress (mean [SD] 1.6 [0.9]) subscales indicated little to no distress. The sample reported mild symptoms of depression (PHQ-9 mean [SD] 8.8 [4.6]); mild symptoms of anxiety (GAD-7 mean, 7.1; SD, 4.4), and Diabetes Empowerment (mean, 31.2; SD, 6.0). Participants described missing an average of 2.4 days within the past 30 days of their T2DM oral medications.

Twelve veterans (92.7%) completed the Follow-up questionnaires. The Figure illustrates statistically significant changes in patient-reported outcomes between baseline and follow-up. Clinically meaningful reductions were shown in total T2DM distress (t₁₁ = 5.03, P < .01), T2DM emotional burden (t₁₁ = 4.83, P = .01), and T2DM regimen-related distress (t₁₁ = 5.14, P < .01). There was a significant increase in T2DM self-efficacy (t₁₁ = 0.32, P = .008) as well. A statistically significant reduction was seen in depressive symptoms (t₁₁ = 2.22, P = .048). While HbA_1c fell by .56 percentage points (standard error of the mean [SEM], 31; P = .10), this change was not statistically significant. Follow-up analyses also showed a clinically, though not statistically, significant reduction in weight loss by 6.9 lb. (SEM, 3.8; P = .20), and reductions of generalized anxiety by 1.2 points (SEM, 1.4; P = .42). Pre- and postanalyses did not show differences among self-rated health, physician-related burden, interpersonal-related burden, and indicators of medication taking behavior.

Discussion

This observational study evaluated change among patient-reported T2DM-specific and general distress measures and health outcomes among a small sample of veterans at VAAAHS medical center that engaged in an episode of individual care with health psychology. Statistically significant decreases were observed in T2DM-related distress. Noteworthy, these decreases were observed for the emotional burden and regimen subscales, and each of these was clinically meaningful, falling below a score of 2.0 on the T2DM-specific scale. This is important given that T2DM distress may interfere with the ability to understand and find motivation for engaging in health behavior change. Incorporating stress management interventions into interdisciplinary health programs has been demonstrated to improve not only levels of distress, but also other health outcomes, such as health related quality of life and cardiac events in heart disease.²³ Thus, behavioral health interventions that incorporate cognitive-behavioral strategies to enhance distress-specific coping may prove important to include among individuals with T2DM.

Reductions in T2DM-related distress also converged with increases observed in the T2DM empowerment scale. These significant improvements in perceived ability suggest increased self-efficacy and willingness to follow a daily T2DM regimen. This finding aligns with the social support literature that demonstrates how instrumental and other aspects of autonomous social support mediate improvements in health-related outcomes and reduced T2DM distress.^24,25 Health psychology interventions strive to both provide social support as well as enhance participants’ perceptions and use of existing support as a cognitive-behavioral strategy. Adding in assessments of social support could shed light on such mediating factors.

The ADA standards of care encourage heath care providers to engage patients in conversations in order to better understand the barriers of T2DM self-care.¹³ How to best support patients within a primary care multidisciplinary team remains unclear.²⁶ T2DM distress and negative reactions to T2DM, including symptoms of anxiety and depression, are common and may require specific referral to a mental health provider if repeated attempts at T2DM education do not improve self-management and illness biomarkers.²⁷ Thus, integrating these providers and services within the medical setting aims to reach more veterans and potentially meet these standards of care. With our health psychology integrated services, clinically significant decreases in anxiety and statistically significant decreases in depressive symptoms were observed that approached “mild to no” symptoms. Although this was not measured formally, the veterans were not engaging in mental health specialty care historically or during the year of the health psychology intervention. This suggests that health psychology services helped bridge the gap and address these psychosocial needs within the small sample.

For clinical measures, modest decreases were observed for HbA_1c and weight. The authors recognize that these changes may not be optimal in terms of health status. A review of the specific patient-centered goals may illuminate this finding. For example, 1 participant had a goal to consume fewer sugary beverages and achieved this behavior change. Yet this change alone may not equate to actual weight loss or a lower HbA_1c. Furthermore, in the context of T2DM-related distress, maintaining current weight and/or blood sugar levels may be a more realistic goal. An evaluation of the specific patient-oriented action goals and observed progress may be important outcomes to include in larger studies. Moreover, while not significant, the average HbA_1c decrease of about 1% is comparable with traditional T2DM education and should be considered in light of the sample’s significant mental health comorbidities. While landmark intensive glucose control trials illustrate significant benefits in reductions of hyperglycemia and nonfatal cardiovascular disease, these reductions are associated with an approximate 2-fold risk of hypoglycemia.^28-30 Thus, the focus on improved glycemic control has been criticized as lacking meaning to patients in contrast to preventing T2DM complications and persevering quality of life.³¹

Limitations and Future Directions

Noted limitations include small sample size, the range of time, and a broad number of sessions given that the intervention was tailored to each veteran. Conclusions drawn from a small sample may be influenced by individual outliers. Given co-occurring conditions and moderate levels of distress, all participants may benefit from additional support resources.

In addition to these considerations, having a comparison group could further strengthen the study as part of an observational database. A between-group comparison could help clinicians better understand what the interventions offer as well as some individual factors that relate to participation and success with behavior change. In the future, studies with a priori hypotheses could also consider the trajectories of weight and blood sugar levels for extended periods; for example, 6 months before the intervention and 6 months following.³² Given the complexity of comorbid mental health and chronic medical conditions in this sample, it also may be important to measure the relationships between chronic physical symptoms as an additional barrier for veterans to make health behavior changes.

Conclusions

The authors believe that the health psychology interventions offered important support and motivation for engagement in health behavior change that led to reduced distress in this patient group. It remains a challenge to engage veterans with psychiatric conditions in mental health care, and simultaneously for health care systems that strive to reduce costs and complications associated with chronic illness management.³³ Aligned with these broader health care goals, the ADA aims to reduce complications and cost and improve outcomes for T2DM with guidelines requiring mental and behavioral health interventions. The authors believe that health psychology interventions are a personalized and feasible bridge to address engagement, illness-related distress while improving patient-satisfaction and T2DM self-management.

Acknowledgments

The authors thank the veterans who participated in the observational study. We thank the VA Ann Arbor Healthcare System Institutional Review Board. For instrumental support for health psychology integrated services, we acknowledge Adam Tremblay, MD, Primary Care Chief, and R.J. Schildhouse, MD, Acting Associate Chief of Staff, Ambulatory Care. The work was supported by the Ambulatory Care Service at the VA Ann Arbor Healthcare System and the VA Office of Academic Affiliations.

Early use of tocilizumab (Actemra) does not reduce myocardial infarct size but modestly increases myocardial salvage in patients with acute ST-segment elevation MI (STEMI), results of the ASSAIL-MI trial suggest.

“We’re among the first to show that you can actually affect the reperfusion injury through anti-inflammatory treatment – it’s sort of a new attack point for treatments in STEMI,” lead author Kaspar Broch, MD, PhD, Oslo University Hospital Rikshospitalet, said in an interview. “What we do now is reperfuse as soon as we can and then add drugs in order to prevent new events, but we don’t really attack the reperfusion injury that occurs when you perform PCI [percutaneous coronary intervention], which has been shown to actually account for some 50% of the final injury.”

The phase 2, proof-of-concept study was prompted by the team’s earlier work in non-STEMI patients, in which a single dose of the interleukin-6 receptor antagonist cut C-reactive protein (CRP) levels by more than 50% during hospitalization and reduced troponin T release after PCI.

For ASSAIL-MI, Dr. Broch and colleagues randomly assigned 199 patients presenting with acute STEMI within 6 hours of symptom onset to a single intravenous injection of 280 mg tocilizumab or placebo during PCI. Patients, study personnel, and caretakers were blinded to treatment. Data were available for 195 patients for the primary endpoint of myocardial salvage index.

As reported in the Journal of the American College of Cardiology, tocilizumab was associated with a higher adjusted myocardial salvage index on cardiac MRI 3-7 days after PCI than placebo (69.3% vs. 63.6%; P = .04).

The extent of microvascular obstruction was less with tocilizumab (0% vs. 4%; P = .03), as was the area under the curve of CRP during hospitalization (1.9 vs. 8.6 mg/L per hour; P < .001).

The final infarct size at 6 months was 21% lower in the tocilizumab group but the difference did not reach statistical significance (7.2% vs. 9.1% of left ventricular mass; P = .08).

There were no between-group differences in troponin T area under the curve during hospitalization (1,614 vs. 2,357 ng/L per hour; P = .13), N-terminal of the prohormone brain natriuretic peptide concentrations at 6 months (79 vs. 63 ng/L; P = .25), or baseline-adjusted left ventricular end-diastolic volume at 6 months (157 vs. 160 mL; P = .54).

Subgroup analyses suggested the positive effect of tocilizumab on myocardial salvage index is limited to patients presenting at least 3 hours after symptom onset versus 3 hours or less (P = .034), with a trend for greater benefit among men versus women (P = .053).

Dr. Broch noted that the absolute effect of tocilizumab on myocardial necrosis was smaller than anticipated when the trial was designed, which may explain the lack of significant reduction in infarct size.

“We were aiming for patients with larger infarctions than we actually ended up with, which is partly due to the strict inclusion criteria and the fact that, with modern treatments, patients don’t end up with large myocardial infarctions,” he said. “But if they had been larger, I think that 20% absolute reduction would have meant a lot in terms of clinical events.”

The study also used a very modest dose of tocilizumab, compared with that used for inflammatory diseases, to minimize a potential negative effect on myocardial healing, for instance, myocardial ruptures, Dr. Broch said. “I’m not sure whether you gain anything by giving a larger dose.”

Serious adverse events were similar in the tocilizumab and placebo groups (19 vs. 15; P = .57). There were no myocardial ruptures, and no patient died or developed heart failure. LDL cholesterol, triglycerides, and liver enzymes increased in the tocilizumab group but were similar at 3 and 6 months.

Frontline Medical News

“IL-6 is a central cytokine involved in all stages of plaque growth, progression, and rupture,” Paul Ridker, MD, MPH, of the Brigham and Women’s Hospital in Boston, and a long-standing investigator in inflammation and atherothrombosis, said in an interview. “These preliminary data in STEMI, like the authors’ prior data in non-STEMI, are consistent with the idea that inhibiting IL-6 could have clinical benefit, a concept that will be taken into a major cardiovascular outcomes trial later this year.”

The cardiovascular outcomes trial, known as ZEUS, will test the novel IL-6 inhibitor ziltivekimab among more than 6,000 very-high-risk atherosclerosis patients who have moderate to severe chronic kidney disease and high sensitivity CRP greater than 2 mg/L, he noted.

Moving beyond IL-1b blockade as done in CANTOS to direct downstream inhibition of IL-6 represents a “logical next scientific step” in the development of anti-inflammatory therapies for acute ischemia and chronic atherosclerosis, Dr. Ridker, who led the CANTOS trial, noted in an accompanying editorial.

“Preventive cardiologists, however, need not wait until outcome trials are complete to use this evolving biological knowledge to their patient’s advantage,” he wrote. “As recently confirmed in the pages of the Journal, exercise, smoking cessation, and a healthy diet reduce both C-reactive protein and IL-6, and clearly have lifelong benefits. Our immediate task is thus to incorporate inflammation inhibition through lifestyle management into our daily practice.”

The study was supported by the South-Eastern Norway Regional Health Authority, Central Norway Regional Health Authority, and Roche, which provided the medicinal products and an unrestricted grant. Dr. Broch has disclosed no relevant financial relationships. Dr. Ridker has received investigator-initiated research grant support from Kowa, Novartis, Amarin, Pfizer, and the National Heart, Lung, and Blood Institute; and has served as a consultant to Novartis, Janssen, Agepha, Flame, Civi Biopharma, Inflazome, Corvidia, Novo Nordisk, SOCAR, IQVIA, and AstraZeneca.

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

Early use of tocilizumab (Actemra) does not reduce myocardial infarct size but modestly increases myocardial salvage in patients with acute ST-segment elevation MI (STEMI), results of the ASSAIL-MI trial suggest.

“We’re among the first to show that you can actually affect the reperfusion injury through anti-inflammatory treatment – it’s sort of a new attack point for treatments in STEMI,” lead author Kaspar Broch, MD, PhD, Oslo University Hospital Rikshospitalet, said in an interview. “What we do now is reperfuse as soon as we can and then add drugs in order to prevent new events, but we don’t really attack the reperfusion injury that occurs when you perform PCI [percutaneous coronary intervention], which has been shown to actually account for some 50% of the final injury.”

The phase 2, proof-of-concept study was prompted by the team’s earlier work in non-STEMI patients, in which a single dose of the interleukin-6 receptor antagonist cut C-reactive protein (CRP) levels by more than 50% during hospitalization and reduced troponin T release after PCI.

For ASSAIL-MI, Dr. Broch and colleagues randomly assigned 199 patients presenting with acute STEMI within 6 hours of symptom onset to a single intravenous injection of 280 mg tocilizumab or placebo during PCI. Patients, study personnel, and caretakers were blinded to treatment. Data were available for 195 patients for the primary endpoint of myocardial salvage index.

As reported in the Journal of the American College of Cardiology, tocilizumab was associated with a higher adjusted myocardial salvage index on cardiac MRI 3-7 days after PCI than placebo (69.3% vs. 63.6%; P = .04).

The extent of microvascular obstruction was less with tocilizumab (0% vs. 4%; P = .03), as was the area under the curve of CRP during hospitalization (1.9 vs. 8.6 mg/L per hour; P < .001).

The final infarct size at 6 months was 21% lower in the tocilizumab group but the difference did not reach statistical significance (7.2% vs. 9.1% of left ventricular mass; P = .08).

There were no between-group differences in troponin T area under the curve during hospitalization (1,614 vs. 2,357 ng/L per hour; P = .13), N-terminal of the prohormone brain natriuretic peptide concentrations at 6 months (79 vs. 63 ng/L; P = .25), or baseline-adjusted left ventricular end-diastolic volume at 6 months (157 vs. 160 mL; P = .54).

Subgroup analyses suggested the positive effect of tocilizumab on myocardial salvage index is limited to patients presenting at least 3 hours after symptom onset versus 3 hours or less (P = .034), with a trend for greater benefit among men versus women (P = .053).

Dr. Broch noted that the absolute effect of tocilizumab on myocardial necrosis was smaller than anticipated when the trial was designed, which may explain the lack of significant reduction in infarct size.

“We were aiming for patients with larger infarctions than we actually ended up with, which is partly due to the strict inclusion criteria and the fact that, with modern treatments, patients don’t end up with large myocardial infarctions,” he said. “But if they had been larger, I think that 20% absolute reduction would have meant a lot in terms of clinical events.”

The study also used a very modest dose of tocilizumab, compared with that used for inflammatory diseases, to minimize a potential negative effect on myocardial healing, for instance, myocardial ruptures, Dr. Broch said. “I’m not sure whether you gain anything by giving a larger dose.”

Serious adverse events were similar in the tocilizumab and placebo groups (19 vs. 15; P = .57). There were no myocardial ruptures, and no patient died or developed heart failure. LDL cholesterol, triglycerides, and liver enzymes increased in the tocilizumab group but were similar at 3 and 6 months.

Frontline Medical News

“IL-6 is a central cytokine involved in all stages of plaque growth, progression, and rupture,” Paul Ridker, MD, MPH, of the Brigham and Women’s Hospital in Boston, and a long-standing investigator in inflammation and atherothrombosis, said in an interview. “These preliminary data in STEMI, like the authors’ prior data in non-STEMI, are consistent with the idea that inhibiting IL-6 could have clinical benefit, a concept that will be taken into a major cardiovascular outcomes trial later this year.”

The cardiovascular outcomes trial, known as ZEUS, will test the novel IL-6 inhibitor ziltivekimab among more than 6,000 very-high-risk atherosclerosis patients who have moderate to severe chronic kidney disease and high sensitivity CRP greater than 2 mg/L, he noted.

Moving beyond IL-1b blockade as done in CANTOS to direct downstream inhibition of IL-6 represents a “logical next scientific step” in the development of anti-inflammatory therapies for acute ischemia and chronic atherosclerosis, Dr. Ridker, who led the CANTOS trial, noted in an accompanying editorial.

“Preventive cardiologists, however, need not wait until outcome trials are complete to use this evolving biological knowledge to their patient’s advantage,” he wrote. “As recently confirmed in the pages of the Journal, exercise, smoking cessation, and a healthy diet reduce both C-reactive protein and IL-6, and clearly have lifelong benefits. Our immediate task is thus to incorporate inflammation inhibition through lifestyle management into our daily practice.”

The study was supported by the South-Eastern Norway Regional Health Authority, Central Norway Regional Health Authority, and Roche, which provided the medicinal products and an unrestricted grant. Dr. Broch has disclosed no relevant financial relationships. Dr. Ridker has received investigator-initiated research grant support from Kowa, Novartis, Amarin, Pfizer, and the National Heart, Lung, and Blood Institute; and has served as a consultant to Novartis, Janssen, Agepha, Flame, Civi Biopharma, Inflazome, Corvidia, Novo Nordisk, SOCAR, IQVIA, and AstraZeneca.

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

Early use of tocilizumab (Actemra) does not reduce myocardial infarct size but modestly increases myocardial salvage in patients with acute ST-segment elevation MI (STEMI), results of the ASSAIL-MI trial suggest.

“We’re among the first to show that you can actually affect the reperfusion injury through anti-inflammatory treatment – it’s sort of a new attack point for treatments in STEMI,” lead author Kaspar Broch, MD, PhD, Oslo University Hospital Rikshospitalet, said in an interview. “What we do now is reperfuse as soon as we can and then add drugs in order to prevent new events, but we don’t really attack the reperfusion injury that occurs when you perform PCI [percutaneous coronary intervention], which has been shown to actually account for some 50% of the final injury.”

The phase 2, proof-of-concept study was prompted by the team’s earlier work in non-STEMI patients, in which a single dose of the interleukin-6 receptor antagonist cut C-reactive protein (CRP) levels by more than 50% during hospitalization and reduced troponin T release after PCI.

For ASSAIL-MI, Dr. Broch and colleagues randomly assigned 199 patients presenting with acute STEMI within 6 hours of symptom onset to a single intravenous injection of 280 mg tocilizumab or placebo during PCI. Patients, study personnel, and caretakers were blinded to treatment. Data were available for 195 patients for the primary endpoint of myocardial salvage index.

As reported in the Journal of the American College of Cardiology, tocilizumab was associated with a higher adjusted myocardial salvage index on cardiac MRI 3-7 days after PCI than placebo (69.3% vs. 63.6%; P = .04).

The extent of microvascular obstruction was less with tocilizumab (0% vs. 4%; P = .03), as was the area under the curve of CRP during hospitalization (1.9 vs. 8.6 mg/L per hour; P < .001).

The final infarct size at 6 months was 21% lower in the tocilizumab group but the difference did not reach statistical significance (7.2% vs. 9.1% of left ventricular mass; P = .08).

There were no between-group differences in troponin T area under the curve during hospitalization (1,614 vs. 2,357 ng/L per hour; P = .13), N-terminal of the prohormone brain natriuretic peptide concentrations at 6 months (79 vs. 63 ng/L; P = .25), or baseline-adjusted left ventricular end-diastolic volume at 6 months (157 vs. 160 mL; P = .54).

Subgroup analyses suggested the positive effect of tocilizumab on myocardial salvage index is limited to patients presenting at least 3 hours after symptom onset versus 3 hours or less (P = .034), with a trend for greater benefit among men versus women (P = .053).

Dr. Broch noted that the absolute effect of tocilizumab on myocardial necrosis was smaller than anticipated when the trial was designed, which may explain the lack of significant reduction in infarct size.

“We were aiming for patients with larger infarctions than we actually ended up with, which is partly due to the strict inclusion criteria and the fact that, with modern treatments, patients don’t end up with large myocardial infarctions,” he said. “But if they had been larger, I think that 20% absolute reduction would have meant a lot in terms of clinical events.”

The study also used a very modest dose of tocilizumab, compared with that used for inflammatory diseases, to minimize a potential negative effect on myocardial healing, for instance, myocardial ruptures, Dr. Broch said. “I’m not sure whether you gain anything by giving a larger dose.”

Serious adverse events were similar in the tocilizumab and placebo groups (19 vs. 15; P = .57). There were no myocardial ruptures, and no patient died or developed heart failure. LDL cholesterol, triglycerides, and liver enzymes increased in the tocilizumab group but were similar at 3 and 6 months.

Frontline Medical News

“IL-6 is a central cytokine involved in all stages of plaque growth, progression, and rupture,” Paul Ridker, MD, MPH, of the Brigham and Women’s Hospital in Boston, and a long-standing investigator in inflammation and atherothrombosis, said in an interview. “These preliminary data in STEMI, like the authors’ prior data in non-STEMI, are consistent with the idea that inhibiting IL-6 could have clinical benefit, a concept that will be taken into a major cardiovascular outcomes trial later this year.”

The cardiovascular outcomes trial, known as ZEUS, will test the novel IL-6 inhibitor ziltivekimab among more than 6,000 very-high-risk atherosclerosis patients who have moderate to severe chronic kidney disease and high sensitivity CRP greater than 2 mg/L, he noted.

Moving beyond IL-1b blockade as done in CANTOS to direct downstream inhibition of IL-6 represents a “logical next scientific step” in the development of anti-inflammatory therapies for acute ischemia and chronic atherosclerosis, Dr. Ridker, who led the CANTOS trial, noted in an accompanying editorial.

“Preventive cardiologists, however, need not wait until outcome trials are complete to use this evolving biological knowledge to their patient’s advantage,” he wrote. “As recently confirmed in the pages of the Journal, exercise, smoking cessation, and a healthy diet reduce both C-reactive protein and IL-6, and clearly have lifelong benefits. Our immediate task is thus to incorporate inflammation inhibition through lifestyle management into our daily practice.”

The study was supported by the South-Eastern Norway Regional Health Authority, Central Norway Regional Health Authority, and Roche, which provided the medicinal products and an unrestricted grant. Dr. Broch has disclosed no relevant financial relationships. Dr. Ridker has received investigator-initiated research grant support from Kowa, Novartis, Amarin, Pfizer, and the National Heart, Lung, and Blood Institute; and has served as a consultant to Novartis, Janssen, Agepha, Flame, Civi Biopharma, Inflazome, Corvidia, Novo Nordisk, SOCAR, IQVIA, and AstraZeneca.

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

Clinicians in pediatrics have noticed a troubling pattern emerge during the pandemic, something that is darkly referred to as “the COVID 19,” or the 19 or more pounds that many of our patients have gained in the past year. This phenomenon has underscored many maxims in pediatric weight management: Mainly that frequent snacking, decreased physical activity, and less parental supervision lead to increased weight gain. But could we be missing another lesson this trend is teaching us? What about the relationship between catastrophe and childhood obesity?

Beyond the increased weight gain with lockdowns, I have observed other evidence in my own practice that childhood trauma or adverse experiences increase obesity. Our electronic medical record system gives an alert when a chart with sensitive information is accessed. One example might be if the patient had been seen at a clinic for children who have been abused. I am heartbroken at how often this happens. Academically, I understand the dire statistics about the incidence of child abuse, but the frequency at which I see this pattern is jarring.

Over the years, one striking correlation became clear among my patient population: Children with obesity were more likely to have been seen in the child abuse clinic than normal-weight peers.

I am far from the only one to have observed this relationship. Television shows focusing on severe obesity, such as “My 600-Pound Life,” often show trauma as both a cause and effect of severe obesity. This theme also became apparent on the show “The Biggest Loser,” which highlighted the difficulty of achieving and maintaining substantial weight loss. If even Hollywood has noticed this association, shouldn’t we be much farther ahead?
 

Pathways to obesity

Adverse childhood experiences (ACE) encompass various causes of child trauma, including abuse or neglect; poverty; household or neighborhood violence; and death, illness, or incarceration of a parent. A pivotal report in 1998 formalized the suspicion that many of us could plainly see: People who suffered ACE have higher incidence of heart disease, COPD, liver disease, incarceration, and drug abuse. For those with six or more ACE, life expectancy averaged 20 years less than those who had none. More recently, a meta-analysis found an odds ratio of 1.46 for adult obesity with known history of childhood trauma.

As a pediatric endocrinologist living in the poorest state of the country, I have clearly observed the correlation between childhood obesity and poverty. While prior generations may have associated child poverty with malnutrition and starvation, we are seeing in modern times that obesity has become a disease of lack. Calorie-dense and processed foods tend to be less expensive, more shelf-stable, and more accessible to people living in both urban and rural food deserts.

I am also a foster mother and have received extensive training in parenting children who have lived through trauma and neglect. For children who have endured food scarcity and deprivation, hoarding food and overeating are expected responses.

But the pathways to abnormal weight gain are myriad and expand beyond binge eating or numbing with food. ACE are particularly troubling because they affect developing brains and the neuroendocrine system; they alter epigenetics and cause heritable changes. Structural brain differences have been evident in the frontopolar cortex, which is linked to centers in the hypothalamus that control appetite. And increased stress raises cortisol release, increases insulin resistance, and alters satiety.
 

Shifting our approach to treatment

The significant cost of ACE is enormous and affects us all. Health professionals in pediatrics must understand these connections to effectively counsel children and their families dealing with obesity. Handing someone a diet plan and lecturing them about weight loss is never effective, but this common tactic is especially cruel if we do not assess for and address underlying pain. Obviously, blame and shame are ineffective motivators for lifestyle change in any circumstance, but these tactics may be especially harmful in the light of childhood trauma.

Screening for ACE is important in every aspect of pediatric care. The presence of obesity, however, should remind us to be more sensitive to the possibility of causative trauma. Clinicians for adults are not off the hook either. Fully 60% of adults suffered ACE and are dealing with the aftermath.

To improve health outcomes across the board, we must screen for trauma and become educated on trauma-informed care. Perhaps the most important first referral for a child suffering ACE and obesity is to a trained counselor or a social worker. Shepherding children through trauma will be more effective for attaining healthy weight than any remedy I can prescribe as an endocrinologist. Furthermore, this is our necessary role as healers. More than ever, we need to approach chronic diseases, including obesity, with the utmost compassion.

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

Clinicians in pediatrics have noticed a troubling pattern emerge during the pandemic, something that is darkly referred to as “the COVID 19,” or the 19 or more pounds that many of our patients have gained in the past year. This phenomenon has underscored many maxims in pediatric weight management: Mainly that frequent snacking, decreased physical activity, and less parental supervision lead to increased weight gain. But could we be missing another lesson this trend is teaching us? What about the relationship between catastrophe and childhood obesity?

Beyond the increased weight gain with lockdowns, I have observed other evidence in my own practice that childhood trauma or adverse experiences increase obesity. Our electronic medical record system gives an alert when a chart with sensitive information is accessed. One example might be if the patient had been seen at a clinic for children who have been abused. I am heartbroken at how often this happens. Academically, I understand the dire statistics about the incidence of child abuse, but the frequency at which I see this pattern is jarring.

Over the years, one striking correlation became clear among my patient population: Children with obesity were more likely to have been seen in the child abuse clinic than normal-weight peers.

I am far from the only one to have observed this relationship. Television shows focusing on severe obesity, such as “My 600-Pound Life,” often show trauma as both a cause and effect of severe obesity. This theme also became apparent on the show “The Biggest Loser,” which highlighted the difficulty of achieving and maintaining substantial weight loss. If even Hollywood has noticed this association, shouldn’t we be much farther ahead?
 

Pathways to obesity

Adverse childhood experiences (ACE) encompass various causes of child trauma, including abuse or neglect; poverty; household or neighborhood violence; and death, illness, or incarceration of a parent. A pivotal report in 1998 formalized the suspicion that many of us could plainly see: People who suffered ACE have higher incidence of heart disease, COPD, liver disease, incarceration, and drug abuse. For those with six or more ACE, life expectancy averaged 20 years less than those who had none. More recently, a meta-analysis found an odds ratio of 1.46 for adult obesity with known history of childhood trauma.

As a pediatric endocrinologist living in the poorest state of the country, I have clearly observed the correlation between childhood obesity and poverty. While prior generations may have associated child poverty with malnutrition and starvation, we are seeing in modern times that obesity has become a disease of lack. Calorie-dense and processed foods tend to be less expensive, more shelf-stable, and more accessible to people living in both urban and rural food deserts.

I am also a foster mother and have received extensive training in parenting children who have lived through trauma and neglect. For children who have endured food scarcity and deprivation, hoarding food and overeating are expected responses.

But the pathways to abnormal weight gain are myriad and expand beyond binge eating or numbing with food. ACE are particularly troubling because they affect developing brains and the neuroendocrine system; they alter epigenetics and cause heritable changes. Structural brain differences have been evident in the frontopolar cortex, which is linked to centers in the hypothalamus that control appetite. And increased stress raises cortisol release, increases insulin resistance, and alters satiety.
 

Shifting our approach to treatment

The significant cost of ACE is enormous and affects us all. Health professionals in pediatrics must understand these connections to effectively counsel children and their families dealing with obesity. Handing someone a diet plan and lecturing them about weight loss is never effective, but this common tactic is especially cruel if we do not assess for and address underlying pain. Obviously, blame and shame are ineffective motivators for lifestyle change in any circumstance, but these tactics may be especially harmful in the light of childhood trauma.

Screening for ACE is important in every aspect of pediatric care. The presence of obesity, however, should remind us to be more sensitive to the possibility of causative trauma. Clinicians for adults are not off the hook either. Fully 60% of adults suffered ACE and are dealing with the aftermath.

To improve health outcomes across the board, we must screen for trauma and become educated on trauma-informed care. Perhaps the most important first referral for a child suffering ACE and obesity is to a trained counselor or a social worker. Shepherding children through trauma will be more effective for attaining healthy weight than any remedy I can prescribe as an endocrinologist. Furthermore, this is our necessary role as healers. More than ever, we need to approach chronic diseases, including obesity, with the utmost compassion.

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

Clinicians in pediatrics have noticed a troubling pattern emerge during the pandemic, something that is darkly referred to as “the COVID 19,” or the 19 or more pounds that many of our patients have gained in the past year. This phenomenon has underscored many maxims in pediatric weight management: Mainly that frequent snacking, decreased physical activity, and less parental supervision lead to increased weight gain. But could we be missing another lesson this trend is teaching us? What about the relationship between catastrophe and childhood obesity?

Beyond the increased weight gain with lockdowns, I have observed other evidence in my own practice that childhood trauma or adverse experiences increase obesity. Our electronic medical record system gives an alert when a chart with sensitive information is accessed. One example might be if the patient had been seen at a clinic for children who have been abused. I am heartbroken at how often this happens. Academically, I understand the dire statistics about the incidence of child abuse, but the frequency at which I see this pattern is jarring.

Over the years, one striking correlation became clear among my patient population: Children with obesity were more likely to have been seen in the child abuse clinic than normal-weight peers.

I am far from the only one to have observed this relationship. Television shows focusing on severe obesity, such as “My 600-Pound Life,” often show trauma as both a cause and effect of severe obesity. This theme also became apparent on the show “The Biggest Loser,” which highlighted the difficulty of achieving and maintaining substantial weight loss. If even Hollywood has noticed this association, shouldn’t we be much farther ahead?
 

Pathways to obesity

Adverse childhood experiences (ACE) encompass various causes of child trauma, including abuse or neglect; poverty; household or neighborhood violence; and death, illness, or incarceration of a parent. A pivotal report in 1998 formalized the suspicion that many of us could plainly see: People who suffered ACE have higher incidence of heart disease, COPD, liver disease, incarceration, and drug abuse. For those with six or more ACE, life expectancy averaged 20 years less than those who had none. More recently, a meta-analysis found an odds ratio of 1.46 for adult obesity with known history of childhood trauma.

As a pediatric endocrinologist living in the poorest state of the country, I have clearly observed the correlation between childhood obesity and poverty. While prior generations may have associated child poverty with malnutrition and starvation, we are seeing in modern times that obesity has become a disease of lack. Calorie-dense and processed foods tend to be less expensive, more shelf-stable, and more accessible to people living in both urban and rural food deserts.

I am also a foster mother and have received extensive training in parenting children who have lived through trauma and neglect. For children who have endured food scarcity and deprivation, hoarding food and overeating are expected responses.

But the pathways to abnormal weight gain are myriad and expand beyond binge eating or numbing with food. ACE are particularly troubling because they affect developing brains and the neuroendocrine system; they alter epigenetics and cause heritable changes. Structural brain differences have been evident in the frontopolar cortex, which is linked to centers in the hypothalamus that control appetite. And increased stress raises cortisol release, increases insulin resistance, and alters satiety.
 

Shifting our approach to treatment

The significant cost of ACE is enormous and affects us all. Health professionals in pediatrics must understand these connections to effectively counsel children and their families dealing with obesity. Handing someone a diet plan and lecturing them about weight loss is never effective, but this common tactic is especially cruel if we do not assess for and address underlying pain. Obviously, blame and shame are ineffective motivators for lifestyle change in any circumstance, but these tactics may be especially harmful in the light of childhood trauma.

Screening for ACE is important in every aspect of pediatric care. The presence of obesity, however, should remind us to be more sensitive to the possibility of causative trauma. Clinicians for adults are not off the hook either. Fully 60% of adults suffered ACE and are dealing with the aftermath.

To improve health outcomes across the board, we must screen for trauma and become educated on trauma-informed care. Perhaps the most important first referral for a child suffering ACE and obesity is to a trained counselor or a social worker. Shepherding children through trauma will be more effective for attaining healthy weight than any remedy I can prescribe as an endocrinologist. Furthermore, this is our necessary role as healers. More than ever, we need to approach chronic diseases, including obesity, with the utmost compassion.

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

Asian Americans with melanoma presented at a younger age but with higher rates of invasive disease and at later stages of disease, compared with non-Hispanic Whites, according to a secondary analysis of data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.

The findings are consistent with previous studies indicating delayed detection of melanoma in Asians, compared with non-Hispanic Whites, and provide a window into Asian American communities specifically, Erica M. Lin, a medical student at Brown University, Providence, R.I., said at the annual Skin of Color Society Symposium. The majority of studies on melanoma in Asians have originated in Asia, noted Ms. Lin, whose coauthor was Eunyoung Cho, ScD, an associate professor in the department of dermatology and director of the clinical and translational research program at Brown University. Their analysis covered registries from 10 geographic areas representing 54% of the U.S. Asian American population over a 25-year period, from 1990 to 2014.

Asian Americans with melanoma were more likely to present at an invasive stage than non-Hispanic Whites (82.9% vs. 72.2%, P < .001), and they were significantly more likely to present when the disease had progressed to a distant stage (9.39% vs. 2.51%, P < .001), even though they were of younger ages at the time of those diagnoses, Ms. Lin reported at the meeting. (The numbers do not account for unknown or unstaged melanoma cases.)

Significantly fewer Asian Americans presented at the “in situ” stage, compared with non-Hispanic Whites (17.11% vs. 27.78%). The lower extremities were the most common site in Asian Americans, compared with the trunk in Non-Hispanic Whites.

The SEER registries covered the eight largest Asian American groups: Asian Indians/Pakistanis, Chinese, Filipinos, Japanese, Kampucheans (Cambodians), Koreans, Laotians, and Vietnamese. Melanoma was more common in females across the groups (53% of females vs. 47% of males), with the exception of Asian Indians/Pakistanis.

While melanoma increased significantly over time among non-Hispanic Whites – a mean 24% increase per 5-year period – there was “no significant change in melanoma rates in Asians,” Ms. Lin said.

The lack of increase in Asian American communities combined with the other findings is “potentially concerning” and suggests “that there may be cases that are not being identified,” she said in an interview after the meeting. In their abstract, she and Dr. Cho noted that their findings underscore the need for further prevention, screening, and surveillance measures.

The NCI’s SEER program is a coordinated system of cancer registries across the United States that collects data on every case of cancer reported in 19 geographic areas.

Asian Americans with melanoma presented at a younger age but with higher rates of invasive disease and at later stages of disease, compared with non-Hispanic Whites, according to a secondary analysis of data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.

The findings are consistent with previous studies indicating delayed detection of melanoma in Asians, compared with non-Hispanic Whites, and provide a window into Asian American communities specifically, Erica M. Lin, a medical student at Brown University, Providence, R.I., said at the annual Skin of Color Society Symposium. The majority of studies on melanoma in Asians have originated in Asia, noted Ms. Lin, whose coauthor was Eunyoung Cho, ScD, an associate professor in the department of dermatology and director of the clinical and translational research program at Brown University. Their analysis covered registries from 10 geographic areas representing 54% of the U.S. Asian American population over a 25-year period, from 1990 to 2014.

Asian Americans with melanoma were more likely to present at an invasive stage than non-Hispanic Whites (82.9% vs. 72.2%, P < .001), and they were significantly more likely to present when the disease had progressed to a distant stage (9.39% vs. 2.51%, P < .001), even though they were of younger ages at the time of those diagnoses, Ms. Lin reported at the meeting. (The numbers do not account for unknown or unstaged melanoma cases.)

Significantly fewer Asian Americans presented at the “in situ” stage, compared with non-Hispanic Whites (17.11% vs. 27.78%). The lower extremities were the most common site in Asian Americans, compared with the trunk in Non-Hispanic Whites.

The SEER registries covered the eight largest Asian American groups: Asian Indians/Pakistanis, Chinese, Filipinos, Japanese, Kampucheans (Cambodians), Koreans, Laotians, and Vietnamese. Melanoma was more common in females across the groups (53% of females vs. 47% of males), with the exception of Asian Indians/Pakistanis.

While melanoma increased significantly over time among non-Hispanic Whites – a mean 24% increase per 5-year period – there was “no significant change in melanoma rates in Asians,” Ms. Lin said.

The lack of increase in Asian American communities combined with the other findings is “potentially concerning” and suggests “that there may be cases that are not being identified,” she said in an interview after the meeting. In their abstract, she and Dr. Cho noted that their findings underscore the need for further prevention, screening, and surveillance measures.

The NCI’s SEER program is a coordinated system of cancer registries across the United States that collects data on every case of cancer reported in 19 geographic areas.

Asian Americans with melanoma presented at a younger age but with higher rates of invasive disease and at later stages of disease, compared with non-Hispanic Whites, according to a secondary analysis of data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.

The findings are consistent with previous studies indicating delayed detection of melanoma in Asians, compared with non-Hispanic Whites, and provide a window into Asian American communities specifically, Erica M. Lin, a medical student at Brown University, Providence, R.I., said at the annual Skin of Color Society Symposium. The majority of studies on melanoma in Asians have originated in Asia, noted Ms. Lin, whose coauthor was Eunyoung Cho, ScD, an associate professor in the department of dermatology and director of the clinical and translational research program at Brown University. Their analysis covered registries from 10 geographic areas representing 54% of the U.S. Asian American population over a 25-year period, from 1990 to 2014.

Asian Americans with melanoma were more likely to present at an invasive stage than non-Hispanic Whites (82.9% vs. 72.2%, P < .001), and they were significantly more likely to present when the disease had progressed to a distant stage (9.39% vs. 2.51%, P < .001), even though they were of younger ages at the time of those diagnoses, Ms. Lin reported at the meeting. (The numbers do not account for unknown or unstaged melanoma cases.)

Significantly fewer Asian Americans presented at the “in situ” stage, compared with non-Hispanic Whites (17.11% vs. 27.78%). The lower extremities were the most common site in Asian Americans, compared with the trunk in Non-Hispanic Whites.

The SEER registries covered the eight largest Asian American groups: Asian Indians/Pakistanis, Chinese, Filipinos, Japanese, Kampucheans (Cambodians), Koreans, Laotians, and Vietnamese. Melanoma was more common in females across the groups (53% of females vs. 47% of males), with the exception of Asian Indians/Pakistanis.

While melanoma increased significantly over time among non-Hispanic Whites – a mean 24% increase per 5-year period – there was “no significant change in melanoma rates in Asians,” Ms. Lin said.

The lack of increase in Asian American communities combined with the other findings is “potentially concerning” and suggests “that there may be cases that are not being identified,” she said in an interview after the meeting. In their abstract, she and Dr. Cho noted that their findings underscore the need for further prevention, screening, and surveillance measures.

The NCI’s SEER program is a coordinated system of cancer registries across the United States that collects data on every case of cancer reported in 19 geographic areas.

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

It’s been more than a year since we came face to face with an unprecedented, unrelenting pandemic. Determined to overcome, determined to forge ahead, we worked tirelessly.

Drazen Zigic/Getty Images

Hours upon hours, days upon days, months upon months. Hoping for recovery while facing the devastation of death. We were praised, and lauded as heroes as we pleaded for essential protective gear and urged our communities to think critically, act responsibly, and distance safely. From the cities to small towns, we answered the call. Leaving long-practiced specialties, reassigned from our practices and training, we worked together uncertain of the future, but committed to safeguarding our present. Through sacrifice we toiled, leaving our families to protect against contagion, wading through halls of the sick and fighting against the threat of death.

Beginning at the beginning

Addressing these issues starts with training. As a new cohort of eager students enters medical/osteopathic school, the focus should lie not only on foundations of medicine and brute memorization of copious information but also on self-care, wellness checks, and group morale. The same emphasis placed upon patient care and advocacy must also be extended toward ensuring that the next generation of physicians will understand the importance of caring for themselves as much as they care for others.

In the same manner, past stereotypes of ruthless, cut-throat, competition must also evolve. Although the spirit of hard work and perseverance is essential, the manner it propagates is just as important. Aggressive questioning, myriad testing, rigid hierarchies, blind obedience, and ego inflation may separate the pack, but it also reinforces individualism and isolation. Students may shield their internal turmoil behind a mask. The mask of the Super Doctor.

However, as the pandemic has shown, even the most durable of masks will eventually fail. So how do we recognize and accept that help is needed? How do we access support? First, it is vital to acknowledge that there is no shame in asking for help. It is both surprising and reassuring that many of us have been there, an unspoken band of brothers and sisters. Second, remember the acronym for depressive symptoms SIGECAPS (sleep, interest, guilt, energy, concentration, appetite, psychomotor, suicide). Remember that these symptoms may develop gradually or feel sudden and overwhelming. Know that mood lability, tearfulness, and isolation may also be present but confused and disregarded as normal consequences of school, residency, or life as a physician. Third, recognize common behavioral changes associated with anxiety, such as irritability, avoidance, and physical symptoms, including headache, muscle aches, joint pain, GI discomfort, palpitations, and insomnia. Last, reach out to colleagues who have suddenly or gradually withdrawn. Schedule frequent check-ins for one another and do not be afraid to admit that you are human. There is no shame in vulnerability but there is bravery and strength.

If you are in school or residency training, reach out to health centers, training directors, supervisors, family and/or friends. Whether you are an early career physician or amid a decades-long career, connect with your peers, reach out to junior members, offer and accept support. Anonymous hotlines, listservs, email groups, virtual meetings, texts, and phone calls also provide opportunities for wellness checks, pep talks, or venting sessions. All are important. In the case where more specialized help is needed, contact your primary care physician, reach out to colleagues in mental health, contact the Suicide Prevention Lifeline at 1-800 273-8255. Know there is help; you are not alone.

In these unprecedented and uncertain times, remember the African proverb “It takes a village.” To ask for help reveals strength and fortitude. The more we advocate for ourselves and one another, the more we will prevail and shed the myth of infallibility.

Dr. Thomas is a board-certified adult psychiatrist with an interest in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. She has no conflicts of interest.

It’s been more than a year since we came face to face with an unprecedented, unrelenting pandemic. Determined to overcome, determined to forge ahead, we worked tirelessly.

Drazen Zigic/Getty Images

Hours upon hours, days upon days, months upon months. Hoping for recovery while facing the devastation of death. We were praised, and lauded as heroes as we pleaded for essential protective gear and urged our communities to think critically, act responsibly, and distance safely. From the cities to small towns, we answered the call. Leaving long-practiced specialties, reassigned from our practices and training, we worked together uncertain of the future, but committed to safeguarding our present. Through sacrifice we toiled, leaving our families to protect against contagion, wading through halls of the sick and fighting against the threat of death.

Beginning at the beginning

Addressing these issues starts with training. As a new cohort of eager students enters medical/osteopathic school, the focus should lie not only on foundations of medicine and brute memorization of copious information but also on self-care, wellness checks, and group morale. The same emphasis placed upon patient care and advocacy must also be extended toward ensuring that the next generation of physicians will understand the importance of caring for themselves as much as they care for others.

In the same manner, past stereotypes of ruthless, cut-throat, competition must also evolve. Although the spirit of hard work and perseverance is essential, the manner it propagates is just as important. Aggressive questioning, myriad testing, rigid hierarchies, blind obedience, and ego inflation may separate the pack, but it also reinforces individualism and isolation. Students may shield their internal turmoil behind a mask. The mask of the Super Doctor.

However, as the pandemic has shown, even the most durable of masks will eventually fail. So how do we recognize and accept that help is needed? How do we access support? First, it is vital to acknowledge that there is no shame in asking for help. It is both surprising and reassuring that many of us have been there, an unspoken band of brothers and sisters. Second, remember the acronym for depressive symptoms SIGECAPS (sleep, interest, guilt, energy, concentration, appetite, psychomotor, suicide). Remember that these symptoms may develop gradually or feel sudden and overwhelming. Know that mood lability, tearfulness, and isolation may also be present but confused and disregarded as normal consequences of school, residency, or life as a physician. Third, recognize common behavioral changes associated with anxiety, such as irritability, avoidance, and physical symptoms, including headache, muscle aches, joint pain, GI discomfort, palpitations, and insomnia. Last, reach out to colleagues who have suddenly or gradually withdrawn. Schedule frequent check-ins for one another and do not be afraid to admit that you are human. There is no shame in vulnerability but there is bravery and strength.

If you are in school or residency training, reach out to health centers, training directors, supervisors, family and/or friends. Whether you are an early career physician or amid a decades-long career, connect with your peers, reach out to junior members, offer and accept support. Anonymous hotlines, listservs, email groups, virtual meetings, texts, and phone calls also provide opportunities for wellness checks, pep talks, or venting sessions. All are important. In the case where more specialized help is needed, contact your primary care physician, reach out to colleagues in mental health, contact the Suicide Prevention Lifeline at 1-800 273-8255. Know there is help; you are not alone.

In these unprecedented and uncertain times, remember the African proverb “It takes a village.” To ask for help reveals strength and fortitude. The more we advocate for ourselves and one another, the more we will prevail and shed the myth of infallibility.

Dr. Thomas is a board-certified adult psychiatrist with an interest in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. She has no conflicts of interest.

It’s been more than a year since we came face to face with an unprecedented, unrelenting pandemic. Determined to overcome, determined to forge ahead, we worked tirelessly.

Drazen Zigic/Getty Images

Hours upon hours, days upon days, months upon months. Hoping for recovery while facing the devastation of death. We were praised, and lauded as heroes as we pleaded for essential protective gear and urged our communities to think critically, act responsibly, and distance safely. From the cities to small towns, we answered the call. Leaving long-practiced specialties, reassigned from our practices and training, we worked together uncertain of the future, but committed to safeguarding our present. Through sacrifice we toiled, leaving our families to protect against contagion, wading through halls of the sick and fighting against the threat of death.

Beginning at the beginning

Addressing these issues starts with training. As a new cohort of eager students enters medical/osteopathic school, the focus should lie not only on foundations of medicine and brute memorization of copious information but also on self-care, wellness checks, and group morale. The same emphasis placed upon patient care and advocacy must also be extended toward ensuring that the next generation of physicians will understand the importance of caring for themselves as much as they care for others.

In the same manner, past stereotypes of ruthless, cut-throat, competition must also evolve. Although the spirit of hard work and perseverance is essential, the manner it propagates is just as important. Aggressive questioning, myriad testing, rigid hierarchies, blind obedience, and ego inflation may separate the pack, but it also reinforces individualism and isolation. Students may shield their internal turmoil behind a mask. The mask of the Super Doctor.

However, as the pandemic has shown, even the most durable of masks will eventually fail. So how do we recognize and accept that help is needed? How do we access support? First, it is vital to acknowledge that there is no shame in asking for help. It is both surprising and reassuring that many of us have been there, an unspoken band of brothers and sisters. Second, remember the acronym for depressive symptoms SIGECAPS (sleep, interest, guilt, energy, concentration, appetite, psychomotor, suicide). Remember that these symptoms may develop gradually or feel sudden and overwhelming. Know that mood lability, tearfulness, and isolation may also be present but confused and disregarded as normal consequences of school, residency, or life as a physician. Third, recognize common behavioral changes associated with anxiety, such as irritability, avoidance, and physical symptoms, including headache, muscle aches, joint pain, GI discomfort, palpitations, and insomnia. Last, reach out to colleagues who have suddenly or gradually withdrawn. Schedule frequent check-ins for one another and do not be afraid to admit that you are human. There is no shame in vulnerability but there is bravery and strength.

If you are in school or residency training, reach out to health centers, training directors, supervisors, family and/or friends. Whether you are an early career physician or amid a decades-long career, connect with your peers, reach out to junior members, offer and accept support. Anonymous hotlines, listservs, email groups, virtual meetings, texts, and phone calls also provide opportunities for wellness checks, pep talks, or venting sessions. All are important. In the case where more specialized help is needed, contact your primary care physician, reach out to colleagues in mental health, contact the Suicide Prevention Lifeline at 1-800 273-8255. Know there is help; you are not alone.

In these unprecedented and uncertain times, remember the African proverb “It takes a village.” To ask for help reveals strength and fortitude. The more we advocate for ourselves and one another, the more we will prevail and shed the myth of infallibility.

Dr. Thomas is a board-certified adult psychiatrist with an interest in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. She has no conflicts of interest.

The Food and Drug Administration has declared Medtronic’s recall of seven models of defibrillating cardiac rhythm devices, caused by a risk for premature battery depletion, as class I, which implies a potential risk for serious injury or death. A total of 444 complaints, but no deaths, have been reported in association with the 239,171 affected devices, the agency said in a statement on April 12, 2021.

Physicians were notified of the company’s recall in early February. It covered implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy–defibrillator (CRT-D) models Evera, Viva, Brava, Claria, Amplia, Compia, and Visia distributed from Aug. 31, 2012 to May 9, 2018.

The devices could be subject to “an unexpected and rapid decrease in battery life” because of a possible short circuit that could lead to a device-replacement alert “earlier than expected.” Some devices may experience full battery depletion “within as little as 1 day” after such an alert.

“If the user does not respond to the first warning, the device may stop functioning. The likelihood that this issue will occur is constant after approximately 3 years after device use,” the announcement said.

Medtronic recommends device replacement no more than 1 week after such an early warning for patients who are not pacing dependent or who have them for primary prevention, but right away for pacing-dependent patients.

A version of this article first appeared on Medscape.com

The Food and Drug Administration has declared Medtronic’s recall of seven models of defibrillating cardiac rhythm devices, caused by a risk for premature battery depletion, as class I, which implies a potential risk for serious injury or death. A total of 444 complaints, but no deaths, have been reported in association with the 239,171 affected devices, the agency said in a statement on April 12, 2021.

Physicians were notified of the company’s recall in early February. It covered implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy–defibrillator (CRT-D) models Evera, Viva, Brava, Claria, Amplia, Compia, and Visia distributed from Aug. 31, 2012 to May 9, 2018.

The devices could be subject to “an unexpected and rapid decrease in battery life” because of a possible short circuit that could lead to a device-replacement alert “earlier than expected.” Some devices may experience full battery depletion “within as little as 1 day” after such an alert.

“If the user does not respond to the first warning, the device may stop functioning. The likelihood that this issue will occur is constant after approximately 3 years after device use,” the announcement said.

Medtronic recommends device replacement no more than 1 week after such an early warning for patients who are not pacing dependent or who have them for primary prevention, but right away for pacing-dependent patients.

A version of this article first appeared on Medscape.com

The Food and Drug Administration has declared Medtronic’s recall of seven models of defibrillating cardiac rhythm devices, caused by a risk for premature battery depletion, as class I, which implies a potential risk for serious injury or death. A total of 444 complaints, but no deaths, have been reported in association with the 239,171 affected devices, the agency said in a statement on April 12, 2021.

Physicians were notified of the company’s recall in early February. It covered implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy–defibrillator (CRT-D) models Evera, Viva, Brava, Claria, Amplia, Compia, and Visia distributed from Aug. 31, 2012 to May 9, 2018.

The devices could be subject to “an unexpected and rapid decrease in battery life” because of a possible short circuit that could lead to a device-replacement alert “earlier than expected.” Some devices may experience full battery depletion “within as little as 1 day” after such an alert.

“If the user does not respond to the first warning, the device may stop functioning. The likelihood that this issue will occur is constant after approximately 3 years after device use,” the announcement said.

Medtronic recommends device replacement no more than 1 week after such an early warning for patients who are not pacing dependent or who have them for primary prevention, but right away for pacing-dependent patients.

A version of this article first appeared on Medscape.com

“Mom, Dad: I’m gay.” Saying these words can be difficult for anyone but especially for adolescents and young adults. The process of coming out is one filled with anticipation, angst, and hopefully relief. However, this process is not a one-time event but rather something that LGBTQ adolescents and young adults have to face every time they meet someone new or are placed in a new situation. They have to decide if that new person can be trusted with their very personal information.

Coming out is a process that begins months to years before the adolescent or young adult utters the words above. The first step in the coming out process is accepting one’s sexual orientation and/or gender identity. This period of time can be somewhat tumultuous, filled with a mix of emotions ranging from fear to excitement. The adolescent or young adult may need support in coming to terms with who they are as their authentic self. This can take the role of a therapist, a trusted friend, or a trusted family member. There may even be times that the adolescent or young adult’s physician is the only person that they are out to besides their friends. Therefore, you can play a very important role in helping your adolescent and young adult patients as they navigate the journey of coming out.

One of the most important ways that physicians can help adolescents and young adults is to spend time alone with them at as many visits as you can. This gives the patient the time to discuss confidential matters with you, including their sexual orientation and/or gender identity. It is possible that the chronic abdominal pain that your adolescent patient is experiencing may not represent an organic abdominal problem but could represent a manifestation of anxiety because that patient is afraid of his/her parent(s) finding out that he/she identifies as LGBTQ. If one of your patients comes out to you, it is important that you validate for your patient that they are normal as who they are. In addition, you can thank your patient for trusting you with that information and let them know that you are there to support them in whatever way they feel appropriate. Just as important is that you work with the adolescent on a plan for their other concerns that respects their right to privacy in regard to their gender identity and/or sexual orientation.

The adolescent or young adult should always be in control of who knows about their gender identity and/or sexual orientation. Ideally, they should also always be the one who shares that information with others. Many times, parents may react positively to finding out that their child identifies as LGBTQ and want to share that information with their friends or family members. Alternatively, the parent could use the patient’s sexual orientation or gender identity negatively against them to their family and/or friends. As the physician, you can help counsel the family that it should always be their child who gets to share that information and when it is shared.

So how can you support your LGBTQ patients as they navigate the coming out process? First, when you find out from your patient that they identify as LGBTQ, ensure that you ask them who knows about their identity. This prevents inadvertent disclosures to the parent/guardian when the patient is not ready for them to know. Second, discuss with the patient if he/she needs any resources related to their sexual orientation and/or gender identity. This includes things such as the names of local LGBTQ youth organizations or the phone number for the Trevor Project suicide hotline, for example. Third, ensure that your office and staff are a welcoming and affirmative environment for your patients. A 2017 survey by the Human Rights Campaign found that only 8% of transgender or gender-diverse adolescents and young adults were out to all of their physicians and only 5% of LGB adolescents and young adults were out to all of their physicians.¹ This is likely because of past negative experiences these patients have had with previous physicians. A 2017 study from the Center for American Progress found that 8% of LGB patients and 29% of transgender or gender-diverse patients said that a doctor or health care provider had refused to see them because of their actual or perceived identity.² Lastly, you could offer to help facilitate a discussion between the patient and his/her parents in relation to his/her sexual orientation and/or gender identity.

In summary, pediatricians can play an important role in the coming out process of their LGBTQ patients. Your office is an important source of support for the physical and mental health of these patients as they navigate this journey. You can also be a strong advocate for these patients to their parents and families. I think that we all can agree that our patients deserve better than only feeling comfortable to be out to 5%-8% of their physicians.

Dr. Cooper is assistant professor of pediatrics at the University of Texas, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Contact him at [email protected].
 

References

1. Human Rights Campaign 2018 LGBTQ Youth Report.

2. Mirza SA and Rooney C. “Discrimination prevents LGBTQ people from accessing health care.” Center for American Progress. 2018 Jan 18.

“Mom, Dad: I’m gay.” Saying these words can be difficult for anyone but especially for adolescents and young adults. The process of coming out is one filled with anticipation, angst, and hopefully relief. However, this process is not a one-time event but rather something that LGBTQ adolescents and young adults have to face every time they meet someone new or are placed in a new situation. They have to decide if that new person can be trusted with their very personal information.

Coming out is a process that begins months to years before the adolescent or young adult utters the words above. The first step in the coming out process is accepting one’s sexual orientation and/or gender identity. This period of time can be somewhat tumultuous, filled with a mix of emotions ranging from fear to excitement. The adolescent or young adult may need support in coming to terms with who they are as their authentic self. This can take the role of a therapist, a trusted friend, or a trusted family member. There may even be times that the adolescent or young adult’s physician is the only person that they are out to besides their friends. Therefore, you can play a very important role in helping your adolescent and young adult patients as they navigate the journey of coming out.

One of the most important ways that physicians can help adolescents and young adults is to spend time alone with them at as many visits as you can. This gives the patient the time to discuss confidential matters with you, including their sexual orientation and/or gender identity. It is possible that the chronic abdominal pain that your adolescent patient is experiencing may not represent an organic abdominal problem but could represent a manifestation of anxiety because that patient is afraid of his/her parent(s) finding out that he/she identifies as LGBTQ. If one of your patients comes out to you, it is important that you validate for your patient that they are normal as who they are. In addition, you can thank your patient for trusting you with that information and let them know that you are there to support them in whatever way they feel appropriate. Just as important is that you work with the adolescent on a plan for their other concerns that respects their right to privacy in regard to their gender identity and/or sexual orientation.

The adolescent or young adult should always be in control of who knows about their gender identity and/or sexual orientation. Ideally, they should also always be the one who shares that information with others. Many times, parents may react positively to finding out that their child identifies as LGBTQ and want to share that information with their friends or family members. Alternatively, the parent could use the patient’s sexual orientation or gender identity negatively against them to their family and/or friends. As the physician, you can help counsel the family that it should always be their child who gets to share that information and when it is shared.

So how can you support your LGBTQ patients as they navigate the coming out process? First, when you find out from your patient that they identify as LGBTQ, ensure that you ask them who knows about their identity. This prevents inadvertent disclosures to the parent/guardian when the patient is not ready for them to know. Second, discuss with the patient if he/she needs any resources related to their sexual orientation and/or gender identity. This includes things such as the names of local LGBTQ youth organizations or the phone number for the Trevor Project suicide hotline, for example. Third, ensure that your office and staff are a welcoming and affirmative environment for your patients. A 2017 survey by the Human Rights Campaign found that only 8% of transgender or gender-diverse adolescents and young adults were out to all of their physicians and only 5% of LGB adolescents and young adults were out to all of their physicians.¹ This is likely because of past negative experiences these patients have had with previous physicians. A 2017 study from the Center for American Progress found that 8% of LGB patients and 29% of transgender or gender-diverse patients said that a doctor or health care provider had refused to see them because of their actual or perceived identity.² Lastly, you could offer to help facilitate a discussion between the patient and his/her parents in relation to his/her sexual orientation and/or gender identity.

In summary, pediatricians can play an important role in the coming out process of their LGBTQ patients. Your office is an important source of support for the physical and mental health of these patients as they navigate this journey. You can also be a strong advocate for these patients to their parents and families. I think that we all can agree that our patients deserve better than only feeling comfortable to be out to 5%-8% of their physicians.

Dr. Cooper is assistant professor of pediatrics at the University of Texas, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Contact him at [email protected].
 

References

1. Human Rights Campaign 2018 LGBTQ Youth Report.

2. Mirza SA and Rooney C. “Discrimination prevents LGBTQ people from accessing health care.” Center for American Progress. 2018 Jan 18.

“Mom, Dad: I’m gay.” Saying these words can be difficult for anyone but especially for adolescents and young adults. The process of coming out is one filled with anticipation, angst, and hopefully relief. However, this process is not a one-time event but rather something that LGBTQ adolescents and young adults have to face every time they meet someone new or are placed in a new situation. They have to decide if that new person can be trusted with their very personal information.

Coming out is a process that begins months to years before the adolescent or young adult utters the words above. The first step in the coming out process is accepting one’s sexual orientation and/or gender identity. This period of time can be somewhat tumultuous, filled with a mix of emotions ranging from fear to excitement. The adolescent or young adult may need support in coming to terms with who they are as their authentic self. This can take the role of a therapist, a trusted friend, or a trusted family member. There may even be times that the adolescent or young adult’s physician is the only person that they are out to besides their friends. Therefore, you can play a very important role in helping your adolescent and young adult patients as they navigate the journey of coming out.

One of the most important ways that physicians can help adolescents and young adults is to spend time alone with them at as many visits as you can. This gives the patient the time to discuss confidential matters with you, including their sexual orientation and/or gender identity. It is possible that the chronic abdominal pain that your adolescent patient is experiencing may not represent an organic abdominal problem but could represent a manifestation of anxiety because that patient is afraid of his/her parent(s) finding out that he/she identifies as LGBTQ. If one of your patients comes out to you, it is important that you validate for your patient that they are normal as who they are. In addition, you can thank your patient for trusting you with that information and let them know that you are there to support them in whatever way they feel appropriate. Just as important is that you work with the adolescent on a plan for their other concerns that respects their right to privacy in regard to their gender identity and/or sexual orientation.

The adolescent or young adult should always be in control of who knows about their gender identity and/or sexual orientation. Ideally, they should also always be the one who shares that information with others. Many times, parents may react positively to finding out that their child identifies as LGBTQ and want to share that information with their friends or family members. Alternatively, the parent could use the patient’s sexual orientation or gender identity negatively against them to their family and/or friends. As the physician, you can help counsel the family that it should always be their child who gets to share that information and when it is shared.

So how can you support your LGBTQ patients as they navigate the coming out process? First, when you find out from your patient that they identify as LGBTQ, ensure that you ask them who knows about their identity. This prevents inadvertent disclosures to the parent/guardian when the patient is not ready for them to know. Second, discuss with the patient if he/she needs any resources related to their sexual orientation and/or gender identity. This includes things such as the names of local LGBTQ youth organizations or the phone number for the Trevor Project suicide hotline, for example. Third, ensure that your office and staff are a welcoming and affirmative environment for your patients. A 2017 survey by the Human Rights Campaign found that only 8% of transgender or gender-diverse adolescents and young adults were out to all of their physicians and only 5% of LGB adolescents and young adults were out to all of their physicians.¹ This is likely because of past negative experiences these patients have had with previous physicians. A 2017 study from the Center for American Progress found that 8% of LGB patients and 29% of transgender or gender-diverse patients said that a doctor or health care provider had refused to see them because of their actual or perceived identity.² Lastly, you could offer to help facilitate a discussion between the patient and his/her parents in relation to his/her sexual orientation and/or gender identity.

In summary, pediatricians can play an important role in the coming out process of their LGBTQ patients. Your office is an important source of support for the physical and mental health of these patients as they navigate this journey. You can also be a strong advocate for these patients to their parents and families. I think that we all can agree that our patients deserve better than only feeling comfortable to be out to 5%-8% of their physicians.

Dr. Cooper is assistant professor of pediatrics at the University of Texas, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. Contact him at [email protected].
 

References

1. Human Rights Campaign 2018 LGBTQ Youth Report.

2. Mirza SA and Rooney C. “Discrimination prevents LGBTQ people from accessing health care.” Center for American Progress. 2018 Jan 18.