Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

 

 

HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

 

 

Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; ajv18@duke.edu

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

 

 

HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

 

 

Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; ajv18@duke.edu

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

 

 

HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

 

 

Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; ajv18@duke.edu

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

THE COMPARISON

A Acral lentiginous melanoma on the sole of the foot of a 30-year-old Black woman. The depth of the lesion was 2 mm with a positive sentinel lymph node biopsy.

B Nodular melanoma on the shoulder of a 63-year-old Hispanic woman. The depth of the lesion was 5.5 mm with a positive sentinel lymph node biopsy.

Melanoma occurs less frequently in individuals with darker skin types than in those with lighter skin types but is associated with higher rates of morbidity and mortality in this patient population.^1-7 In the cases shown here (A and B), both patients had advanced melanomas with large primary lesions and lymph node metastases.

Epidemiology

A systematic review by Higgins et al⁶ reported the following on the epidemiology of melanomas in patients with skin of color:

• African Americans have deeper tumors at the time of diagnosis, in addition to increased rates of regionally advanced and distant disease. Lesions generally are located on the lower extremities and have an increased propensity for ulceration. Acral lentiginous melanoma is the most common melanoma subtype found in African American patients.⁶
• In Hispanic individuals, superficial spreading melanoma is the most common melanoma subtype. Lower extremity lesions are more common relative to White individuals. Hispanic individuals have the highest rate of oral cavity melanomas across all ethnic groups.⁶
• In Asian individuals, acral and subungual sites are most common. Specifically, Pacific Islanders have the highest proportion of mucosal melanomas across all ethnic groups.⁶

Key clinical features in people with darker skin tones

Melanomas are found more often on the palms, soles, nail units, oral cavity, and mucosae.⁶ The melanomas have the same clinical and dermoscopic features found in individuals with lighter skin tones.

Worth noting

Factors that may contribute to the diagnosis of more advanced melanomas in racial/ethnic minorities in the United States include:

• decreased access to health care based on lack of health insurance and low socioeconomic status,
• less awareness of the risk of melanoma among patients and health care providers because melanoma is less common in persons of color, and
• lesions found in areas less likely to be seen in screening examinations, such as the soles of the feet and the oral and genital mucosae.

Health disparity highlight

• In a large US study of 96,953 patients with a diagnosis of cutaneous melanoma from 1992 to 2009, the proportion of later-stage melanoma—stages II to IV—was greater in Black patients compared to White patients.⁷
• Based on this same data set, White patients had the longest survival time (P <. 05), followed by Hispanic (P < .05), Asian American/Native American/Pacific Islander (P < .05), and Black (P < .05) patients, respectively.⁷
• In Miami-Dade County, one study of 1690 melanoma cases found that 48% of Black patients had regional or distant disease at presentation compared to 22% of White patients (P = .015).⁵ Analysis of multiple factors found that only race was a significant predictor for late-stage melanoma (P < .001). Black patients in this study were 3 times more likely than others to be diagnosed with melanoma at a late stage (P = .07).5
• Black patients in the United States are more likely to have a delayed time from diagnosis to definitive surgery even when researchers controlled for type of health insurance and stage of diagnosis.⁸

Final thoughts

Efforts are needed to overcome these disparities by:

• educating patients with skin of color and their health care providers about the risks of advanced melanoma with the goal of prevention and earlier diagnosis;
• breaking down barriers to care caused by poverty, lack of health insurance, and systemic racism; and
• eliminating factors that lead to delays from diagnosis to definitive surgery.

THE COMPARISON

A Acral lentiginous melanoma on the sole of the foot of a 30-year-old Black woman. The depth of the lesion was 2 mm with a positive sentinel lymph node biopsy.

B Nodular melanoma on the shoulder of a 63-year-old Hispanic woman. The depth of the lesion was 5.5 mm with a positive sentinel lymph node biopsy.

Melanoma occurs less frequently in individuals with darker skin types than in those with lighter skin types but is associated with higher rates of morbidity and mortality in this patient population.^1-7 In the cases shown here (A and B), both patients had advanced melanomas with large primary lesions and lymph node metastases.

Epidemiology

A systematic review by Higgins et al⁶ reported the following on the epidemiology of melanomas in patients with skin of color:

• African Americans have deeper tumors at the time of diagnosis, in addition to increased rates of regionally advanced and distant disease. Lesions generally are located on the lower extremities and have an increased propensity for ulceration. Acral lentiginous melanoma is the most common melanoma subtype found in African American patients.⁶
• In Hispanic individuals, superficial spreading melanoma is the most common melanoma subtype. Lower extremity lesions are more common relative to White individuals. Hispanic individuals have the highest rate of oral cavity melanomas across all ethnic groups.⁶
• In Asian individuals, acral and subungual sites are most common. Specifically, Pacific Islanders have the highest proportion of mucosal melanomas across all ethnic groups.⁶

Key clinical features in people with darker skin tones

Melanomas are found more often on the palms, soles, nail units, oral cavity, and mucosae.⁶ The melanomas have the same clinical and dermoscopic features found in individuals with lighter skin tones.

Worth noting

Factors that may contribute to the diagnosis of more advanced melanomas in racial/ethnic minorities in the United States include:

• decreased access to health care based on lack of health insurance and low socioeconomic status,
• less awareness of the risk of melanoma among patients and health care providers because melanoma is less common in persons of color, and
• lesions found in areas less likely to be seen in screening examinations, such as the soles of the feet and the oral and genital mucosae.

Health disparity highlight

• In a large US study of 96,953 patients with a diagnosis of cutaneous melanoma from 1992 to 2009, the proportion of later-stage melanoma—stages II to IV—was greater in Black patients compared to White patients.⁷
• Based on this same data set, White patients had the longest survival time (P <. 05), followed by Hispanic (P < .05), Asian American/Native American/Pacific Islander (P < .05), and Black (P < .05) patients, respectively.⁷
• In Miami-Dade County, one study of 1690 melanoma cases found that 48% of Black patients had regional or distant disease at presentation compared to 22% of White patients (P = .015).⁵ Analysis of multiple factors found that only race was a significant predictor for late-stage melanoma (P < .001). Black patients in this study were 3 times more likely than others to be diagnosed with melanoma at a late stage (P = .07).5
• Black patients in the United States are more likely to have a delayed time from diagnosis to definitive surgery even when researchers controlled for type of health insurance and stage of diagnosis.⁸

Final thoughts

Efforts are needed to overcome these disparities by:

• educating patients with skin of color and their health care providers about the risks of advanced melanoma with the goal of prevention and earlier diagnosis;
• breaking down barriers to care caused by poverty, lack of health insurance, and systemic racism; and
• eliminating factors that lead to delays from diagnosis to definitive surgery.

THE COMPARISON

A Acral lentiginous melanoma on the sole of the foot of a 30-year-old Black woman. The depth of the lesion was 2 mm with a positive sentinel lymph node biopsy.

B Nodular melanoma on the shoulder of a 63-year-old Hispanic woman. The depth of the lesion was 5.5 mm with a positive sentinel lymph node biopsy.

Melanoma occurs less frequently in individuals with darker skin types than in those with lighter skin types but is associated with higher rates of morbidity and mortality in this patient population.^1-7 In the cases shown here (A and B), both patients had advanced melanomas with large primary lesions and lymph node metastases.

Epidemiology

A systematic review by Higgins et al⁶ reported the following on the epidemiology of melanomas in patients with skin of color:

• African Americans have deeper tumors at the time of diagnosis, in addition to increased rates of regionally advanced and distant disease. Lesions generally are located on the lower extremities and have an increased propensity for ulceration. Acral lentiginous melanoma is the most common melanoma subtype found in African American patients.⁶
• In Hispanic individuals, superficial spreading melanoma is the most common melanoma subtype. Lower extremity lesions are more common relative to White individuals. Hispanic individuals have the highest rate of oral cavity melanomas across all ethnic groups.⁶
• In Asian individuals, acral and subungual sites are most common. Specifically, Pacific Islanders have the highest proportion of mucosal melanomas across all ethnic groups.⁶

Key clinical features in people with darker skin tones

Melanomas are found more often on the palms, soles, nail units, oral cavity, and mucosae.⁶ The melanomas have the same clinical and dermoscopic features found in individuals with lighter skin tones.

Worth noting

Factors that may contribute to the diagnosis of more advanced melanomas in racial/ethnic minorities in the United States include:

• decreased access to health care based on lack of health insurance and low socioeconomic status,
• less awareness of the risk of melanoma among patients and health care providers because melanoma is less common in persons of color, and
• lesions found in areas less likely to be seen in screening examinations, such as the soles of the feet and the oral and genital mucosae.

Health disparity highlight

• In a large US study of 96,953 patients with a diagnosis of cutaneous melanoma from 1992 to 2009, the proportion of later-stage melanoma—stages II to IV—was greater in Black patients compared to White patients.⁷
• Based on this same data set, White patients had the longest survival time (P <. 05), followed by Hispanic (P < .05), Asian American/Native American/Pacific Islander (P < .05), and Black (P < .05) patients, respectively.⁷
• In Miami-Dade County, one study of 1690 melanoma cases found that 48% of Black patients had regional or distant disease at presentation compared to 22% of White patients (P = .015).⁵ Analysis of multiple factors found that only race was a significant predictor for late-stage melanoma (P < .001). Black patients in this study were 3 times more likely than others to be diagnosed with melanoma at a late stage (P = .07).5
• Black patients in the United States are more likely to have a delayed time from diagnosis to definitive surgery even when researchers controlled for type of health insurance and stage of diagnosis.⁸

Final thoughts

Efforts are needed to overcome these disparities by:

• educating patients with skin of color and their health care providers about the risks of advanced melanoma with the goal of prevention and earlier diagnosis;
• breaking down barriers to care caused by poverty, lack of health insurance, and systemic racism; and
• eliminating factors that lead to delays from diagnosis to definitive surgery.

An investigational, novel oral antibiotic with greater selectivity than vancomycin, metronidazole, and even fidaxomicin may offer improved protection of healthy gut bacteria during the treatment of Clostridium difficile infection (CDI), according to ongoing research.

“CDI treatment has historically been dominated by metronidazole and vancomycin,” said Katherine Johnson, DO, from the Western Infectious Disease Consultants, P.C., Denver. However, these broad-spectrum drugs negatively affect healthy bacteria in the gut and increase the risk of CDI recurrence.

This is also a problem for drugs in the CDI antibiotic pipeline: Many candidate drugs have failed because of their broad-spectrum activity, she added during a session at the Peggy Lillis Foundation 2022 National C. diff. Advocacy Summit.

“An ideal CDI therapy would be a very narrow-spectrum antibiotic that has a minimal effect on normal gut bacteria,” she said.

Dr. Johnson is currently working on a phase 2 clinical trial that is evaluating the novel antibiotic, dubbed CRS3123, for the treatment of primary CDI and first-recurrence CDI. The investigational agent targets and inhibits a form of the methionyl tRNA synthetase enzyme, which is strictly required for protein biosynthesis in C. diff. and is therefore an ideal target for treatment of primary and recurrent CDI.

In her session, Dr. Johnson reported that CRS3123 inhibits the damaging toxins produced by C. diff., potentially resulting in more rapid symptom resolution. Additionally, owing to its novel mode of action, no strains are currently resistant to CRS3123.

She presented findings from an animal study that showed that CRS3123 was superior to vancomycin in terms of prolonging survival. She also presented findings from phase 1 clinical trials that showed that most adverse events (AEs) associated with CRS3123 were mild. No serious AEs were reported.
 

A ‘huge infectious burden’

If successful in further research, CRS3123 could offer significant value to patients with C. diff., especially those with recurrent infection, given the sometimes extreme clinical, quality-of-life, and economic burdens associated with CDI.

“CDI is a huge infectious burden to the U.S. health care system and globally has been listed by the Centers for Disease Control and Prevention as an urgent threat,” Byron Vaughn, MD, from the University of Minnesota, told this news organization.

“Despite a number of antibiotic stewardship and infection control and prevention efforts, we haven’t seen much of a change in the incidence of CDI,” he said. He said that the risk of recurrence can be as high as 30%.

While oral vancomycin is effective for treating C. diff., Dr. Vaughn noted that the antibiotic lacks selectivity and destroys healthy gut bacteria, resulting in substantial dysbiosis. “Dysbiosis is really the key to getting recurrent C. diff.,” he explained, “because if you have healthy gut bacteria, you will inherently resist CDI.”

Dr. Vaughn stated that his center is in the startup phase for being a site for a clinical trial of CRS3123. The hope is that CRS3123, because its spectrum is narrower than that of fidaxomicin and vancomycin, doesn’t induce intestinal dysbiosis. “It really just treats the C. diff. and leaves every other bug alone so that your gut bacteria can recover while the C. diff. is being treated,” he said. “And then when you stop CRS3123, you have healthy gut bacteria already present to prevent recurrence.”

If this is confirmed in large-scale trials, there could be a “dramatic decrease” in the rates of recurrent C. diff., said Dr. Vaughn.

Aside from the potential clinical impact, the economic implications of a novel selective antibiotic that preserves healthy gut bacteria could be significant, he added. “Depending on exactly what population you’re looking at, probably about a third of the cost of C. diff. is actually attributable to recurrence. That’s a huge economic burden that could be improved.”

Dr. Johnson is an employee of Crestone, which is developing CRS3123. Dr. Vaughn reports no relevant financial relationships.

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

An investigational, novel oral antibiotic with greater selectivity than vancomycin, metronidazole, and even fidaxomicin may offer improved protection of healthy gut bacteria during the treatment of Clostridium difficile infection (CDI), according to ongoing research.

“CDI treatment has historically been dominated by metronidazole and vancomycin,” said Katherine Johnson, DO, from the Western Infectious Disease Consultants, P.C., Denver. However, these broad-spectrum drugs negatively affect healthy bacteria in the gut and increase the risk of CDI recurrence.

This is also a problem for drugs in the CDI antibiotic pipeline: Many candidate drugs have failed because of their broad-spectrum activity, she added during a session at the Peggy Lillis Foundation 2022 National C. diff. Advocacy Summit.

“An ideal CDI therapy would be a very narrow-spectrum antibiotic that has a minimal effect on normal gut bacteria,” she said.

Dr. Johnson is currently working on a phase 2 clinical trial that is evaluating the novel antibiotic, dubbed CRS3123, for the treatment of primary CDI and first-recurrence CDI. The investigational agent targets and inhibits a form of the methionyl tRNA synthetase enzyme, which is strictly required for protein biosynthesis in C. diff. and is therefore an ideal target for treatment of primary and recurrent CDI.

In her session, Dr. Johnson reported that CRS3123 inhibits the damaging toxins produced by C. diff., potentially resulting in more rapid symptom resolution. Additionally, owing to its novel mode of action, no strains are currently resistant to CRS3123.

She presented findings from an animal study that showed that CRS3123 was superior to vancomycin in terms of prolonging survival. She also presented findings from phase 1 clinical trials that showed that most adverse events (AEs) associated with CRS3123 were mild. No serious AEs were reported.
 

A ‘huge infectious burden’

If successful in further research, CRS3123 could offer significant value to patients with C. diff., especially those with recurrent infection, given the sometimes extreme clinical, quality-of-life, and economic burdens associated with CDI.

“CDI is a huge infectious burden to the U.S. health care system and globally has been listed by the Centers for Disease Control and Prevention as an urgent threat,” Byron Vaughn, MD, from the University of Minnesota, told this news organization.

“Despite a number of antibiotic stewardship and infection control and prevention efforts, we haven’t seen much of a change in the incidence of CDI,” he said. He said that the risk of recurrence can be as high as 30%.

While oral vancomycin is effective for treating C. diff., Dr. Vaughn noted that the antibiotic lacks selectivity and destroys healthy gut bacteria, resulting in substantial dysbiosis. “Dysbiosis is really the key to getting recurrent C. diff.,” he explained, “because if you have healthy gut bacteria, you will inherently resist CDI.”

Dr. Vaughn stated that his center is in the startup phase for being a site for a clinical trial of CRS3123. The hope is that CRS3123, because its spectrum is narrower than that of fidaxomicin and vancomycin, doesn’t induce intestinal dysbiosis. “It really just treats the C. diff. and leaves every other bug alone so that your gut bacteria can recover while the C. diff. is being treated,” he said. “And then when you stop CRS3123, you have healthy gut bacteria already present to prevent recurrence.”

If this is confirmed in large-scale trials, there could be a “dramatic decrease” in the rates of recurrent C. diff., said Dr. Vaughn.

Aside from the potential clinical impact, the economic implications of a novel selective antibiotic that preserves healthy gut bacteria could be significant, he added. “Depending on exactly what population you’re looking at, probably about a third of the cost of C. diff. is actually attributable to recurrence. That’s a huge economic burden that could be improved.”

Dr. Johnson is an employee of Crestone, which is developing CRS3123. Dr. Vaughn reports no relevant financial relationships.

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

An investigational, novel oral antibiotic with greater selectivity than vancomycin, metronidazole, and even fidaxomicin may offer improved protection of healthy gut bacteria during the treatment of Clostridium difficile infection (CDI), according to ongoing research.

“CDI treatment has historically been dominated by metronidazole and vancomycin,” said Katherine Johnson, DO, from the Western Infectious Disease Consultants, P.C., Denver. However, these broad-spectrum drugs negatively affect healthy bacteria in the gut and increase the risk of CDI recurrence.

This is also a problem for drugs in the CDI antibiotic pipeline: Many candidate drugs have failed because of their broad-spectrum activity, she added during a session at the Peggy Lillis Foundation 2022 National C. diff. Advocacy Summit.

“An ideal CDI therapy would be a very narrow-spectrum antibiotic that has a minimal effect on normal gut bacteria,” she said.

Dr. Johnson is currently working on a phase 2 clinical trial that is evaluating the novel antibiotic, dubbed CRS3123, for the treatment of primary CDI and first-recurrence CDI. The investigational agent targets and inhibits a form of the methionyl tRNA synthetase enzyme, which is strictly required for protein biosynthesis in C. diff. and is therefore an ideal target for treatment of primary and recurrent CDI.

In her session, Dr. Johnson reported that CRS3123 inhibits the damaging toxins produced by C. diff., potentially resulting in more rapid symptom resolution. Additionally, owing to its novel mode of action, no strains are currently resistant to CRS3123.

She presented findings from an animal study that showed that CRS3123 was superior to vancomycin in terms of prolonging survival. She also presented findings from phase 1 clinical trials that showed that most adverse events (AEs) associated with CRS3123 were mild. No serious AEs were reported.
 

A ‘huge infectious burden’

If successful in further research, CRS3123 could offer significant value to patients with C. diff., especially those with recurrent infection, given the sometimes extreme clinical, quality-of-life, and economic burdens associated with CDI.

“CDI is a huge infectious burden to the U.S. health care system and globally has been listed by the Centers for Disease Control and Prevention as an urgent threat,” Byron Vaughn, MD, from the University of Minnesota, told this news organization.

“Despite a number of antibiotic stewardship and infection control and prevention efforts, we haven’t seen much of a change in the incidence of CDI,” he said. He said that the risk of recurrence can be as high as 30%.

While oral vancomycin is effective for treating C. diff., Dr. Vaughn noted that the antibiotic lacks selectivity and destroys healthy gut bacteria, resulting in substantial dysbiosis. “Dysbiosis is really the key to getting recurrent C. diff.,” he explained, “because if you have healthy gut bacteria, you will inherently resist CDI.”

Dr. Vaughn stated that his center is in the startup phase for being a site for a clinical trial of CRS3123. The hope is that CRS3123, because its spectrum is narrower than that of fidaxomicin and vancomycin, doesn’t induce intestinal dysbiosis. “It really just treats the C. diff. and leaves every other bug alone so that your gut bacteria can recover while the C. diff. is being treated,” he said. “And then when you stop CRS3123, you have healthy gut bacteria already present to prevent recurrence.”

If this is confirmed in large-scale trials, there could be a “dramatic decrease” in the rates of recurrent C. diff., said Dr. Vaughn.

Aside from the potential clinical impact, the economic implications of a novel selective antibiotic that preserves healthy gut bacteria could be significant, he added. “Depending on exactly what population you’re looking at, probably about a third of the cost of C. diff. is actually attributable to recurrence. That’s a huge economic burden that could be improved.”

Dr. Johnson is an employee of Crestone, which is developing CRS3123. Dr. Vaughn reports no relevant financial relationships.

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

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

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

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

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

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

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

Screening for chronic obstructive pulmonary disease (COPD) in asymptomatic adults has no net benefit, according to a U.S. Preventive Services Task Force (USPSTF) reassessment of its 2016 screening recommendations. The new recommendation is in line with the previous one and is made with moderate certainty (grade D evidence).

The USPSTF recommendation applies to adults who do not recognize or report respiratory symptoms. It does not apply to people with symptoms such as chronic cough, sputum production, difficulty breathing, or wheezing, or those known to be at very high risk for COPD. These latter include people with alpha-1 antitrypsin deficiency or workers exposed to certain toxins at their jobs, according to the report published in JAMA.

“Considering that the outcomes of several other chronic conditions, including cardiovascular disease and cancer, have been improved over the years with early detection and intervention, it is logical to ask whether screening to achieve early detection of COPD might also lead to better outcomes,” Surya P. Bhatt, MD, of the University of Alabama at Birmingham, and George T. O’Connor, MD, of the Boston University, explained in an editorial.
 

Task force assessment

The task force examined relevant publications after the 2016 deliberations and found no new studies that directly assessed the effects of screening for COPD in asymptomatic adults on morbidity, mortality, or health-related quality of life.

Although, as in their previous review, serious harms from treatment trials were not consistently reported, more recent large observational studies in screen-relevant populations suggested possible harms from the initiation of long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and the use of inhaled corticosteroids.

“In addition to potential treatment harms, there are opportunity costs to screening that may include time spent on counseling and providing services and patient referrals for diagnostic testing,” the task force stated.

Because cigarette smoking is the leading cause of COPD, the USPSTF has reiterated its recommendations for physicians to address tobacco smoking cessation in adults, including pregnant persons, as well as tobacco use in children and adolescents.
 

Not the whole story?

“Truly asymptomatic individuals with airflow obstruction do not meet criteria for COPD therapy, but sensitive questionnaires may detect symptoms not previously reported by the patient. It may be more effective to redirect the focus from screening for asymptomatic COPD to case finding using sensitive and cost-effective tools,” Dr. Bhatt and Dr. O’Connor suggested in their editorial.

“Even though available data may not support screening asymptomatic adults for COPD, there is substantial rationale for further investigation of strategies to enhance earlier detection of this condition,” they concluded.
 

More research needed

Despite the recommendation, the USPSTF indicated that further studies are needed to fill in research gaps, including:

• The effectiveness of screening asymptomatic adults for COPD to reduce morbidity or mortality or improve health-related quality of life, with long-term follow-up.
• The effectiveness of early treatment for asymptomatic, minimally symptomatic, or screen-detected populations to slow disease progression and improve health outcomes, with long-term follow-up.
• The harms of screening in and treatment of persons with asymptomatic or minimally symptomatic COPD.

The USPSTF is an independent, voluntary body, and potential conflicts of interest of the members are on file with the organization. Dr. Bhatt reported serving on an advisory board for Boehringer Ingelheim and receiving consulting fees from Sanofi/Regeneron; and Dr. O’Connor reported receiving consulting fees from Grupo Menarini and Dicerna Pharmaceuticals.

Screening for chronic obstructive pulmonary disease (COPD) in asymptomatic adults has no net benefit, according to a U.S. Preventive Services Task Force (USPSTF) reassessment of its 2016 screening recommendations. The new recommendation is in line with the previous one and is made with moderate certainty (grade D evidence).

The USPSTF recommendation applies to adults who do not recognize or report respiratory symptoms. It does not apply to people with symptoms such as chronic cough, sputum production, difficulty breathing, or wheezing, or those known to be at very high risk for COPD. These latter include people with alpha-1 antitrypsin deficiency or workers exposed to certain toxins at their jobs, according to the report published in JAMA.

“Considering that the outcomes of several other chronic conditions, including cardiovascular disease and cancer, have been improved over the years with early detection and intervention, it is logical to ask whether screening to achieve early detection of COPD might also lead to better outcomes,” Surya P. Bhatt, MD, of the University of Alabama at Birmingham, and George T. O’Connor, MD, of the Boston University, explained in an editorial.
 

Task force assessment

The task force examined relevant publications after the 2016 deliberations and found no new studies that directly assessed the effects of screening for COPD in asymptomatic adults on morbidity, mortality, or health-related quality of life.

Although, as in their previous review, serious harms from treatment trials were not consistently reported, more recent large observational studies in screen-relevant populations suggested possible harms from the initiation of long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and the use of inhaled corticosteroids.

“In addition to potential treatment harms, there are opportunity costs to screening that may include time spent on counseling and providing services and patient referrals for diagnostic testing,” the task force stated.

Because cigarette smoking is the leading cause of COPD, the USPSTF has reiterated its recommendations for physicians to address tobacco smoking cessation in adults, including pregnant persons, as well as tobacco use in children and adolescents.
 

Not the whole story?

“Truly asymptomatic individuals with airflow obstruction do not meet criteria for COPD therapy, but sensitive questionnaires may detect symptoms not previously reported by the patient. It may be more effective to redirect the focus from screening for asymptomatic COPD to case finding using sensitive and cost-effective tools,” Dr. Bhatt and Dr. O’Connor suggested in their editorial.

“Even though available data may not support screening asymptomatic adults for COPD, there is substantial rationale for further investigation of strategies to enhance earlier detection of this condition,” they concluded.
 

More research needed

Despite the recommendation, the USPSTF indicated that further studies are needed to fill in research gaps, including:

• The effectiveness of screening asymptomatic adults for COPD to reduce morbidity or mortality or improve health-related quality of life, with long-term follow-up.
• The effectiveness of early treatment for asymptomatic, minimally symptomatic, or screen-detected populations to slow disease progression and improve health outcomes, with long-term follow-up.
• The harms of screening in and treatment of persons with asymptomatic or minimally symptomatic COPD.

The USPSTF is an independent, voluntary body, and potential conflicts of interest of the members are on file with the organization. Dr. Bhatt reported serving on an advisory board for Boehringer Ingelheim and receiving consulting fees from Sanofi/Regeneron; and Dr. O’Connor reported receiving consulting fees from Grupo Menarini and Dicerna Pharmaceuticals.

Screening for chronic obstructive pulmonary disease (COPD) in asymptomatic adults has no net benefit, according to a U.S. Preventive Services Task Force (USPSTF) reassessment of its 2016 screening recommendations. The new recommendation is in line with the previous one and is made with moderate certainty (grade D evidence).

The USPSTF recommendation applies to adults who do not recognize or report respiratory symptoms. It does not apply to people with symptoms such as chronic cough, sputum production, difficulty breathing, or wheezing, or those known to be at very high risk for COPD. These latter include people with alpha-1 antitrypsin deficiency or workers exposed to certain toxins at their jobs, according to the report published in JAMA.

“Considering that the outcomes of several other chronic conditions, including cardiovascular disease and cancer, have been improved over the years with early detection and intervention, it is logical to ask whether screening to achieve early detection of COPD might also lead to better outcomes,” Surya P. Bhatt, MD, of the University of Alabama at Birmingham, and George T. O’Connor, MD, of the Boston University, explained in an editorial.
 

Task force assessment

The task force examined relevant publications after the 2016 deliberations and found no new studies that directly assessed the effects of screening for COPD in asymptomatic adults on morbidity, mortality, or health-related quality of life.

Although, as in their previous review, serious harms from treatment trials were not consistently reported, more recent large observational studies in screen-relevant populations suggested possible harms from the initiation of long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and the use of inhaled corticosteroids.

“In addition to potential treatment harms, there are opportunity costs to screening that may include time spent on counseling and providing services and patient referrals for diagnostic testing,” the task force stated.

Because cigarette smoking is the leading cause of COPD, the USPSTF has reiterated its recommendations for physicians to address tobacco smoking cessation in adults, including pregnant persons, as well as tobacco use in children and adolescents.
 

Not the whole story?

“Truly asymptomatic individuals with airflow obstruction do not meet criteria for COPD therapy, but sensitive questionnaires may detect symptoms not previously reported by the patient. It may be more effective to redirect the focus from screening for asymptomatic COPD to case finding using sensitive and cost-effective tools,” Dr. Bhatt and Dr. O’Connor suggested in their editorial.

“Even though available data may not support screening asymptomatic adults for COPD, there is substantial rationale for further investigation of strategies to enhance earlier detection of this condition,” they concluded.
 

More research needed

Despite the recommendation, the USPSTF indicated that further studies are needed to fill in research gaps, including:

• The effectiveness of screening asymptomatic adults for COPD to reduce morbidity or mortality or improve health-related quality of life, with long-term follow-up.
• The effectiveness of early treatment for asymptomatic, minimally symptomatic, or screen-detected populations to slow disease progression and improve health outcomes, with long-term follow-up.
• The harms of screening in and treatment of persons with asymptomatic or minimally symptomatic COPD.

The USPSTF is an independent, voluntary body, and potential conflicts of interest of the members are on file with the organization. Dr. Bhatt reported serving on an advisory board for Boehringer Ingelheim and receiving consulting fees from Sanofi/Regeneron; and Dr. O’Connor reported receiving consulting fees from Grupo Menarini and Dicerna Pharmaceuticals.

New York City (NYC) was the early epicenter of the COVID-19 pandemic in the United States. By late March 2020, NYC hospitals were overwhelmed, leading to the development of a 452-bed field hospital that became the Javits New York Medical Station (JNYMS).^1,2 More than 600 uniformed and other federal personnel, including medical personnel from US Army, Navy, and Public Health Service Commissioned Corps, mobilized to provide medical support to the JNYMS in late March 2020, leading to the treatment of more than 1000 patients with COVID-19 within a 30-day period.¹

Literature from the SARS, Ebola, and HIV epidemics indicate that adverse mental health consequences, including burnout, depression, and posttraumatic stress disorder symptoms are common in frontline medical workers.^3,4 Emerging data shows a similar trend occurring during the COVID-19 pandemic.⁵ A recent publication detailed the role of a federal force health protection program created to enhance resiliency of deployed officers during the COVID-19 pandemic, but this focused primarily on providing remote services to frontline workers.⁶ Another report addressed mental health interventions for health care workers in an academic health care system in NYC during COVID-19.⁷ However, there has been little published on real-time mental health support for deployed personnel during the pandemic.

Prior publications have described the patient flow, infection control measures, and development of a Consultation-Liaison Psychiatry Service in the JNYMS.^2,8,9 Here, we detail the establishment of preventative and responsive mental health services for frontline workers at the JNYMS and explore lessons learned through the outpatient and general support experiences.

Development of Outpatient Mental Health Support Services

At the end of March 2020, the Jacob K. Javits Convention Center was repurposed into the 452-bed JNYMS field hospital, where exposition rooms were transformed into a medical unit and intensive care unit.² While the majority of personnel providing direct clinical care were specialists, the station also was staffed with uniformed and other federal mental health clinicians, including 5 licensed clinical social workers (LCSWs), 3 psychiatrists, 1 dual-trained internal medicine–psychiatry physician, 1 psychiatric nurse, and 2 behavioral health technicians. To standardize processes early in the deployment, standard operating procedures for behavioral health support of personnel were developed and disseminated within the first few days of the deployment.

The initial mission of the behavioral health team was to establish comprehensive mental health services, as the rapidly shifting mission and unfamiliar environment increased the risk of new-onset stress responses and exacerbating pre-existing stressors in personnel. Behavioral health leadership established operations in conference rooms within the convention center, focusing on identifying, prioritizing, and staffing high-traffic areas. A resiliency center was also established adjacent to the changing room, where all staff would enter and leave the units, and to the dining facility, further increasing traffic. This center was staffed 24 hours a day by at least 1 LCSW and a behavioral health technician with 2 shifts: one from 0630 to 1830 and another from 1830 to 0630. Psychiatrists were available during the day for psychiatry intervention and evaluations, and an on-call schedule was developed for off-hours to provide time-sensitive responses.

The resiliency center was developed to provide a welcoming atmosphere to meet basic needs, including nourishment, healthy social interaction, and a calm environment. Water and food were made available free to personnel, bolstering morale for staff working 12-hour shifts in a pandemic treatment floor where personal protective equipment prevented intake of food or water. Mental health staff were also available to counsel and provide social support to personnel. If personnel wished to discuss stressors or appeared to be in distress, a mental health clinician would provide a real-time intervention or schedule an appointment with the behavioral health team. Resources were made available, including brochures and other reading materials on resilience, stress management, and other mental health topics. Uniformed services and state and federal JNYMS leadership were encouraged to visit the resiliency center to normalize interactions and encourage participation in a behavioral health environment. Signage was placed throughout JNYMS to direct personnel to behavioral health services.

The behavioral health interventions and influence spread from the resiliency center nexus. Initially, therapeutic interventions occurred where and when necessary. One psychiatrist provided crisis intervention to a bereaved soldier in the stairwell within 2 hours of arrival to the JNYMS. Leadership and the behavioral health team recognized that the need for privacy was essential for timely therapeutic interventions, leading to the development of a private individual counseling room. As the area became generally accepted as the central hub of behavioral health activity, space was provided to establish a quiet space and a meditation room. The quiet area provided a cool dark space for personnel to sit quietly in solitude; many were grateful for this reprieve after an overstimulating medical shift. The meditation room supplied sterilized yoga mats for personal mindfulness interventions. The behavioral health team also liaised with military chaplains, who established a spiritual service room near the resiliency center. The chaplains held regular religious services and were available 24 hours a day for timely spiritual interventions.

Rapid notification and movement of uniformed personnel to JNYMS resulted in limited ability for personnel to schedule medical appointments and refill medications. Psychiatrists also had limited access to relevant electronic health record systems. This led to a delay in nonurgent care to evaluate personnel records and confirm prescriptions, especially controlled medications. Local pharmacies filled prescriptions, psychiatrists placed electronic health profiles, and command teams were notified in accordance with US Army and federal regulations.

Medical Unit Support Services

Although a robust outpatient behavioral health service was laid out in the JNYMS, the behavioral health team recognized the need to provide mental health interventions within the main patient care areas as well. The intention was to maximize availability and support while minimizing interference to patient care. As previously described, a psychiatric consultation-liaison (CL) team was organized and operated 24 hours a day by early April 2020.⁹ Indeed, CL psychiatrists have played a valuable role in supporting the unique patient and staff needs in other COVID-19 treatment environments.¹⁰ The CL team at JNYMS observed that medical staff were exposed to multiple stressors, including fear of acquiring COVID-19, treating patients with significant medical comorbidities, practicing outside of clinical specialty, working with unfamiliar and limited equipment, and adjusting to frequently shifting changes in personnel and work schedules. Moreover, psychological stress was compounded by long shifts, jetlag, and continuous wear of extensive personal protective equipment, as has been documented in other COVID-19 treatment centers.¹¹

The team of psychiatrists conducted informal rounds to nursing stations to evaluate the morale and develop relationships with the medical team, including nurses, physicians, medics, and other personnel. Areas of high stress and increased interpersonal conflict were identified for more frequent check-ins by mental health clinicians. The psychiatrists and LCSWs were available for informal walk-in therapy when requested by personnel. When the acuity increased, personnel could be accompanied to the individual counseling room for rapid therapeutic interventions. The CL psychiatrists developed professional relationships with the command and medical leadership teams. Through these relationships and sensitive awareness of morale in the medical work environment, psychiatrists were able to advocate for alterations in the nursing work schedule. Leadership was receptive and resultant changes decreased the hours per shift and number of shifts for most nurses. Morale quickly improved, likely resulting in improved quality of patient care and prevention of burnout.

Mental Health Care Beyond JNYMS

Uniformed services and other federal personnel further supplemented health care operations beyond JYNMS. In April 2020, Urban Augmentation Medical Task Forces were organized and distributed throughout regions where COVID-19–related hospitalizations had significantly overwhelmed the local health care force. Urban Augmentation Medical Task Forces often included a psychiatrist, psychologist, and behavioral health technician with the mission to provide mental health support and interventions to patients and medical staff. Combat Operational Stress Control units from US Army medical brigades operated in NYC and the greater northeast region, providing mental health support and resiliency training to military personnel working in civilian hospitals, medical centers, and other health care or support environments. In addition, a LCSW and behavioral health technician worked with New York Army Reserve personnel assigned to mortuary affairs, providing point-of-care interventions at or near the worksite.

A collaborative federal, uniformed services, and state operation led to the development of the HERO-NY: Healing, Education, Resilience, and Opportunity for New York’s Frontline Workforce “Train the Trainer” Series.¹² The series was intended to use uniformed services expertise to address mental health challenges related to the COVID-19 epidemic. Psychiatrists and mental health clinicians from JNYMS modeled small group trainings for future medical trainers. In lieu of traditional unidirectional lecturing, which yields limited retention and learning, the panelists demonstrated how to lead interactive small group training with resiliency topics, including goal setting, communication, anger management, and sleep hygiene.

Transition

After the last patient was discharged from JNYMS in May 2020, personnel were quickly redeployed to their duty stations. At the time of mission completion, the JNYMS behavioral health team had been supplemented with psychiatrists, social workers, behavioral health technicians, psychiatric nurse practitioners, psychiatric nurses, and psychologists representing US Public Health Service Commissioned Corps, Army, Air Force, and Navy, and provided comprehensive support to the nearly 1100 patients with COVID-19 and 600 deployed federal and state medical and support personnel.

Lessons Learned and Future Considerations

Behavioral health care provided at JNYMS offers insight into support of frontline workers in pandemic settings, as literature is limited in this area.¹³ TheJNYMS behavioral health team used strategies similar to military medical interventions in limited and unpredictable environments, such as rapid formalization of team structure and establishment of standard operating procedures to facilitate uniformity across interventions. Physical space was necessary to create an environment conducive to productive mental health interventions, including therapy rooms and quiet and spiritual spaces. Placing behavioral resources in high-traffic areas normalized mental health and maximized accessibility to interventions. Mental health personnel also addressed issues in the work environment, such as providing informal support and crisis interventions to frontline workers. Finally, Urban Augmentation Medical Task Forces mental health personnel and Combat Operational Stress Control units provided therapeutic interventions and resiliency training for military and civilian personnel throughout burdened medical systems beyond JNYMS.

Future operations should consider what equipment and logistic access are necessary to provide psychiatric and psychological care to mobilized federal and uniformed personnel, such as access to frontline worker electronic health records. Given that prior work has found that provision of resources alone is inadequate, frontline medical workers must be aware of where resources are available (eg, signage) and have easy access to material (eg, brochures) focusing on resiliency and psychological health.¹⁴ The spaces can be used for formal psychiatric and psychological interventions, such as assessment, therapy, and medication management. Equally important, these spaces serve as a safe place for healthy social interaction and fulfillment of basic needs (eg, nourishment) and a peaceful environment free of stimulation.

Since mental health personnel provide varied services ranging from basic human interaction to complex crisis interventions, mental health personnel should supplement pandemic medical operations. Evidence supports the notion that effective communication and cohesion throughout the entire leadership and health care team structure can improve resilience and implementation of mental health interventions.¹⁵ Incorporating mental health personnel into leadership planning meetings would allow for timely recommendations to improve medical logistics and planning of deployment of behavioral health resources. As a general rule, providing behavioral health experts with a seat at the table enhances advocacy and command awareness of the morale and mental health of frontline personnel.

Conclusions

We present the experience of developing mental health support services for deployed personnel during the COVID-19 pandemic and address the real-time mental health treatment and support of deployed uniformed services and federal personnel in the COVID-19 response environment. Timely and effective interventions included securing safe therapeutic space in high-traffic areas, developing relationships with leadership and frontline workers in their own work environments, and disseminating such services throughout the civilian medical system.

Mental health supplementation during the medical response mission strengthened morale in frontline workers in a disaster scenario. We hope that this report and others like it will provide information to improve mental health responses, reinforce mental health support, and encourage research in evidence-based interventions in challenging pandemic and disaster settings.

Acknowledgments

We would like to acknowledge and thank those serving on the frontlines of the COVID-19 pandemic.

New York City (NYC) was the early epicenter of the COVID-19 pandemic in the United States. By late March 2020, NYC hospitals were overwhelmed, leading to the development of a 452-bed field hospital that became the Javits New York Medical Station (JNYMS).^1,2 More than 600 uniformed and other federal personnel, including medical personnel from US Army, Navy, and Public Health Service Commissioned Corps, mobilized to provide medical support to the JNYMS in late March 2020, leading to the treatment of more than 1000 patients with COVID-19 within a 30-day period.¹

Literature from the SARS, Ebola, and HIV epidemics indicate that adverse mental health consequences, including burnout, depression, and posttraumatic stress disorder symptoms are common in frontline medical workers.^3,4 Emerging data shows a similar trend occurring during the COVID-19 pandemic.⁵ A recent publication detailed the role of a federal force health protection program created to enhance resiliency of deployed officers during the COVID-19 pandemic, but this focused primarily on providing remote services to frontline workers.⁶ Another report addressed mental health interventions for health care workers in an academic health care system in NYC during COVID-19.⁷ However, there has been little published on real-time mental health support for deployed personnel during the pandemic.

Prior publications have described the patient flow, infection control measures, and development of a Consultation-Liaison Psychiatry Service in the JNYMS.^2,8,9 Here, we detail the establishment of preventative and responsive mental health services for frontline workers at the JNYMS and explore lessons learned through the outpatient and general support experiences.

Development of Outpatient Mental Health Support Services

At the end of March 2020, the Jacob K. Javits Convention Center was repurposed into the 452-bed JNYMS field hospital, where exposition rooms were transformed into a medical unit and intensive care unit.² While the majority of personnel providing direct clinical care were specialists, the station also was staffed with uniformed and other federal mental health clinicians, including 5 licensed clinical social workers (LCSWs), 3 psychiatrists, 1 dual-trained internal medicine–psychiatry physician, 1 psychiatric nurse, and 2 behavioral health technicians. To standardize processes early in the deployment, standard operating procedures for behavioral health support of personnel were developed and disseminated within the first few days of the deployment.

The initial mission of the behavioral health team was to establish comprehensive mental health services, as the rapidly shifting mission and unfamiliar environment increased the risk of new-onset stress responses and exacerbating pre-existing stressors in personnel. Behavioral health leadership established operations in conference rooms within the convention center, focusing on identifying, prioritizing, and staffing high-traffic areas. A resiliency center was also established adjacent to the changing room, where all staff would enter and leave the units, and to the dining facility, further increasing traffic. This center was staffed 24 hours a day by at least 1 LCSW and a behavioral health technician with 2 shifts: one from 0630 to 1830 and another from 1830 to 0630. Psychiatrists were available during the day for psychiatry intervention and evaluations, and an on-call schedule was developed for off-hours to provide time-sensitive responses.

The resiliency center was developed to provide a welcoming atmosphere to meet basic needs, including nourishment, healthy social interaction, and a calm environment. Water and food were made available free to personnel, bolstering morale for staff working 12-hour shifts in a pandemic treatment floor where personal protective equipment prevented intake of food or water. Mental health staff were also available to counsel and provide social support to personnel. If personnel wished to discuss stressors or appeared to be in distress, a mental health clinician would provide a real-time intervention or schedule an appointment with the behavioral health team. Resources were made available, including brochures and other reading materials on resilience, stress management, and other mental health topics. Uniformed services and state and federal JNYMS leadership were encouraged to visit the resiliency center to normalize interactions and encourage participation in a behavioral health environment. Signage was placed throughout JNYMS to direct personnel to behavioral health services.

The behavioral health interventions and influence spread from the resiliency center nexus. Initially, therapeutic interventions occurred where and when necessary. One psychiatrist provided crisis intervention to a bereaved soldier in the stairwell within 2 hours of arrival to the JNYMS. Leadership and the behavioral health team recognized that the need for privacy was essential for timely therapeutic interventions, leading to the development of a private individual counseling room. As the area became generally accepted as the central hub of behavioral health activity, space was provided to establish a quiet space and a meditation room. The quiet area provided a cool dark space for personnel to sit quietly in solitude; many were grateful for this reprieve after an overstimulating medical shift. The meditation room supplied sterilized yoga mats for personal mindfulness interventions. The behavioral health team also liaised with military chaplains, who established a spiritual service room near the resiliency center. The chaplains held regular religious services and were available 24 hours a day for timely spiritual interventions.

Rapid notification and movement of uniformed personnel to JNYMS resulted in limited ability for personnel to schedule medical appointments and refill medications. Psychiatrists also had limited access to relevant electronic health record systems. This led to a delay in nonurgent care to evaluate personnel records and confirm prescriptions, especially controlled medications. Local pharmacies filled prescriptions, psychiatrists placed electronic health profiles, and command teams were notified in accordance with US Army and federal regulations.

Medical Unit Support Services

Although a robust outpatient behavioral health service was laid out in the JNYMS, the behavioral health team recognized the need to provide mental health interventions within the main patient care areas as well. The intention was to maximize availability and support while minimizing interference to patient care. As previously described, a psychiatric consultation-liaison (CL) team was organized and operated 24 hours a day by early April 2020.⁹ Indeed, CL psychiatrists have played a valuable role in supporting the unique patient and staff needs in other COVID-19 treatment environments.¹⁰ The CL team at JNYMS observed that medical staff were exposed to multiple stressors, including fear of acquiring COVID-19, treating patients with significant medical comorbidities, practicing outside of clinical specialty, working with unfamiliar and limited equipment, and adjusting to frequently shifting changes in personnel and work schedules. Moreover, psychological stress was compounded by long shifts, jetlag, and continuous wear of extensive personal protective equipment, as has been documented in other COVID-19 treatment centers.¹¹

The team of psychiatrists conducted informal rounds to nursing stations to evaluate the morale and develop relationships with the medical team, including nurses, physicians, medics, and other personnel. Areas of high stress and increased interpersonal conflict were identified for more frequent check-ins by mental health clinicians. The psychiatrists and LCSWs were available for informal walk-in therapy when requested by personnel. When the acuity increased, personnel could be accompanied to the individual counseling room for rapid therapeutic interventions. The CL psychiatrists developed professional relationships with the command and medical leadership teams. Through these relationships and sensitive awareness of morale in the medical work environment, psychiatrists were able to advocate for alterations in the nursing work schedule. Leadership was receptive and resultant changes decreased the hours per shift and number of shifts for most nurses. Morale quickly improved, likely resulting in improved quality of patient care and prevention of burnout.

Mental Health Care Beyond JNYMS

Uniformed services and other federal personnel further supplemented health care operations beyond JYNMS. In April 2020, Urban Augmentation Medical Task Forces were organized and distributed throughout regions where COVID-19–related hospitalizations had significantly overwhelmed the local health care force. Urban Augmentation Medical Task Forces often included a psychiatrist, psychologist, and behavioral health technician with the mission to provide mental health support and interventions to patients and medical staff. Combat Operational Stress Control units from US Army medical brigades operated in NYC and the greater northeast region, providing mental health support and resiliency training to military personnel working in civilian hospitals, medical centers, and other health care or support environments. In addition, a LCSW and behavioral health technician worked with New York Army Reserve personnel assigned to mortuary affairs, providing point-of-care interventions at or near the worksite.

A collaborative federal, uniformed services, and state operation led to the development of the HERO-NY: Healing, Education, Resilience, and Opportunity for New York’s Frontline Workforce “Train the Trainer” Series.¹² The series was intended to use uniformed services expertise to address mental health challenges related to the COVID-19 epidemic. Psychiatrists and mental health clinicians from JNYMS modeled small group trainings for future medical trainers. In lieu of traditional unidirectional lecturing, which yields limited retention and learning, the panelists demonstrated how to lead interactive small group training with resiliency topics, including goal setting, communication, anger management, and sleep hygiene.

Transition

After the last patient was discharged from JNYMS in May 2020, personnel were quickly redeployed to their duty stations. At the time of mission completion, the JNYMS behavioral health team had been supplemented with psychiatrists, social workers, behavioral health technicians, psychiatric nurse practitioners, psychiatric nurses, and psychologists representing US Public Health Service Commissioned Corps, Army, Air Force, and Navy, and provided comprehensive support to the nearly 1100 patients with COVID-19 and 600 deployed federal and state medical and support personnel.

Lessons Learned and Future Considerations

Behavioral health care provided at JNYMS offers insight into support of frontline workers in pandemic settings, as literature is limited in this area.¹³ TheJNYMS behavioral health team used strategies similar to military medical interventions in limited and unpredictable environments, such as rapid formalization of team structure and establishment of standard operating procedures to facilitate uniformity across interventions. Physical space was necessary to create an environment conducive to productive mental health interventions, including therapy rooms and quiet and spiritual spaces. Placing behavioral resources in high-traffic areas normalized mental health and maximized accessibility to interventions. Mental health personnel also addressed issues in the work environment, such as providing informal support and crisis interventions to frontline workers. Finally, Urban Augmentation Medical Task Forces mental health personnel and Combat Operational Stress Control units provided therapeutic interventions and resiliency training for military and civilian personnel throughout burdened medical systems beyond JNYMS.

Future operations should consider what equipment and logistic access are necessary to provide psychiatric and psychological care to mobilized federal and uniformed personnel, such as access to frontline worker electronic health records. Given that prior work has found that provision of resources alone is inadequate, frontline medical workers must be aware of where resources are available (eg, signage) and have easy access to material (eg, brochures) focusing on resiliency and psychological health.¹⁴ The spaces can be used for formal psychiatric and psychological interventions, such as assessment, therapy, and medication management. Equally important, these spaces serve as a safe place for healthy social interaction and fulfillment of basic needs (eg, nourishment) and a peaceful environment free of stimulation.

Since mental health personnel provide varied services ranging from basic human interaction to complex crisis interventions, mental health personnel should supplement pandemic medical operations. Evidence supports the notion that effective communication and cohesion throughout the entire leadership and health care team structure can improve resilience and implementation of mental health interventions.¹⁵ Incorporating mental health personnel into leadership planning meetings would allow for timely recommendations to improve medical logistics and planning of deployment of behavioral health resources. As a general rule, providing behavioral health experts with a seat at the table enhances advocacy and command awareness of the morale and mental health of frontline personnel.

Conclusions

We present the experience of developing mental health support services for deployed personnel during the COVID-19 pandemic and address the real-time mental health treatment and support of deployed uniformed services and federal personnel in the COVID-19 response environment. Timely and effective interventions included securing safe therapeutic space in high-traffic areas, developing relationships with leadership and frontline workers in their own work environments, and disseminating such services throughout the civilian medical system.

Mental health supplementation during the medical response mission strengthened morale in frontline workers in a disaster scenario. We hope that this report and others like it will provide information to improve mental health responses, reinforce mental health support, and encourage research in evidence-based interventions in challenging pandemic and disaster settings.

Acknowledgments

We would like to acknowledge and thank those serving on the frontlines of the COVID-19 pandemic.

New York City (NYC) was the early epicenter of the COVID-19 pandemic in the United States. By late March 2020, NYC hospitals were overwhelmed, leading to the development of a 452-bed field hospital that became the Javits New York Medical Station (JNYMS).^1,2 More than 600 uniformed and other federal personnel, including medical personnel from US Army, Navy, and Public Health Service Commissioned Corps, mobilized to provide medical support to the JNYMS in late March 2020, leading to the treatment of more than 1000 patients with COVID-19 within a 30-day period.¹

Literature from the SARS, Ebola, and HIV epidemics indicate that adverse mental health consequences, including burnout, depression, and posttraumatic stress disorder symptoms are common in frontline medical workers.^3,4 Emerging data shows a similar trend occurring during the COVID-19 pandemic.⁵ A recent publication detailed the role of a federal force health protection program created to enhance resiliency of deployed officers during the COVID-19 pandemic, but this focused primarily on providing remote services to frontline workers.⁶ Another report addressed mental health interventions for health care workers in an academic health care system in NYC during COVID-19.⁷ However, there has been little published on real-time mental health support for deployed personnel during the pandemic.

Prior publications have described the patient flow, infection control measures, and development of a Consultation-Liaison Psychiatry Service in the JNYMS.^2,8,9 Here, we detail the establishment of preventative and responsive mental health services for frontline workers at the JNYMS and explore lessons learned through the outpatient and general support experiences.

Development of Outpatient Mental Health Support Services

At the end of March 2020, the Jacob K. Javits Convention Center was repurposed into the 452-bed JNYMS field hospital, where exposition rooms were transformed into a medical unit and intensive care unit.² While the majority of personnel providing direct clinical care were specialists, the station also was staffed with uniformed and other federal mental health clinicians, including 5 licensed clinical social workers (LCSWs), 3 psychiatrists, 1 dual-trained internal medicine–psychiatry physician, 1 psychiatric nurse, and 2 behavioral health technicians. To standardize processes early in the deployment, standard operating procedures for behavioral health support of personnel were developed and disseminated within the first few days of the deployment.

The initial mission of the behavioral health team was to establish comprehensive mental health services, as the rapidly shifting mission and unfamiliar environment increased the risk of new-onset stress responses and exacerbating pre-existing stressors in personnel. Behavioral health leadership established operations in conference rooms within the convention center, focusing on identifying, prioritizing, and staffing high-traffic areas. A resiliency center was also established adjacent to the changing room, where all staff would enter and leave the units, and to the dining facility, further increasing traffic. This center was staffed 24 hours a day by at least 1 LCSW and a behavioral health technician with 2 shifts: one from 0630 to 1830 and another from 1830 to 0630. Psychiatrists were available during the day for psychiatry intervention and evaluations, and an on-call schedule was developed for off-hours to provide time-sensitive responses.

The resiliency center was developed to provide a welcoming atmosphere to meet basic needs, including nourishment, healthy social interaction, and a calm environment. Water and food were made available free to personnel, bolstering morale for staff working 12-hour shifts in a pandemic treatment floor where personal protective equipment prevented intake of food or water. Mental health staff were also available to counsel and provide social support to personnel. If personnel wished to discuss stressors or appeared to be in distress, a mental health clinician would provide a real-time intervention or schedule an appointment with the behavioral health team. Resources were made available, including brochures and other reading materials on resilience, stress management, and other mental health topics. Uniformed services and state and federal JNYMS leadership were encouraged to visit the resiliency center to normalize interactions and encourage participation in a behavioral health environment. Signage was placed throughout JNYMS to direct personnel to behavioral health services.

The behavioral health interventions and influence spread from the resiliency center nexus. Initially, therapeutic interventions occurred where and when necessary. One psychiatrist provided crisis intervention to a bereaved soldier in the stairwell within 2 hours of arrival to the JNYMS. Leadership and the behavioral health team recognized that the need for privacy was essential for timely therapeutic interventions, leading to the development of a private individual counseling room. As the area became generally accepted as the central hub of behavioral health activity, space was provided to establish a quiet space and a meditation room. The quiet area provided a cool dark space for personnel to sit quietly in solitude; many were grateful for this reprieve after an overstimulating medical shift. The meditation room supplied sterilized yoga mats for personal mindfulness interventions. The behavioral health team also liaised with military chaplains, who established a spiritual service room near the resiliency center. The chaplains held regular religious services and were available 24 hours a day for timely spiritual interventions.

Rapid notification and movement of uniformed personnel to JNYMS resulted in limited ability for personnel to schedule medical appointments and refill medications. Psychiatrists also had limited access to relevant electronic health record systems. This led to a delay in nonurgent care to evaluate personnel records and confirm prescriptions, especially controlled medications. Local pharmacies filled prescriptions, psychiatrists placed electronic health profiles, and command teams were notified in accordance with US Army and federal regulations.

Medical Unit Support Services

Although a robust outpatient behavioral health service was laid out in the JNYMS, the behavioral health team recognized the need to provide mental health interventions within the main patient care areas as well. The intention was to maximize availability and support while minimizing interference to patient care. As previously described, a psychiatric consultation-liaison (CL) team was organized and operated 24 hours a day by early April 2020.⁹ Indeed, CL psychiatrists have played a valuable role in supporting the unique patient and staff needs in other COVID-19 treatment environments.¹⁰ The CL team at JNYMS observed that medical staff were exposed to multiple stressors, including fear of acquiring COVID-19, treating patients with significant medical comorbidities, practicing outside of clinical specialty, working with unfamiliar and limited equipment, and adjusting to frequently shifting changes in personnel and work schedules. Moreover, psychological stress was compounded by long shifts, jetlag, and continuous wear of extensive personal protective equipment, as has been documented in other COVID-19 treatment centers.¹¹

The team of psychiatrists conducted informal rounds to nursing stations to evaluate the morale and develop relationships with the medical team, including nurses, physicians, medics, and other personnel. Areas of high stress and increased interpersonal conflict were identified for more frequent check-ins by mental health clinicians. The psychiatrists and LCSWs were available for informal walk-in therapy when requested by personnel. When the acuity increased, personnel could be accompanied to the individual counseling room for rapid therapeutic interventions. The CL psychiatrists developed professional relationships with the command and medical leadership teams. Through these relationships and sensitive awareness of morale in the medical work environment, psychiatrists were able to advocate for alterations in the nursing work schedule. Leadership was receptive and resultant changes decreased the hours per shift and number of shifts for most nurses. Morale quickly improved, likely resulting in improved quality of patient care and prevention of burnout.

Mental Health Care Beyond JNYMS

Uniformed services and other federal personnel further supplemented health care operations beyond JYNMS. In April 2020, Urban Augmentation Medical Task Forces were organized and distributed throughout regions where COVID-19–related hospitalizations had significantly overwhelmed the local health care force. Urban Augmentation Medical Task Forces often included a psychiatrist, psychologist, and behavioral health technician with the mission to provide mental health support and interventions to patients and medical staff. Combat Operational Stress Control units from US Army medical brigades operated in NYC and the greater northeast region, providing mental health support and resiliency training to military personnel working in civilian hospitals, medical centers, and other health care or support environments. In addition, a LCSW and behavioral health technician worked with New York Army Reserve personnel assigned to mortuary affairs, providing point-of-care interventions at or near the worksite.

A collaborative federal, uniformed services, and state operation led to the development of the HERO-NY: Healing, Education, Resilience, and Opportunity for New York’s Frontline Workforce “Train the Trainer” Series.¹² The series was intended to use uniformed services expertise to address mental health challenges related to the COVID-19 epidemic. Psychiatrists and mental health clinicians from JNYMS modeled small group trainings for future medical trainers. In lieu of traditional unidirectional lecturing, which yields limited retention and learning, the panelists demonstrated how to lead interactive small group training with resiliency topics, including goal setting, communication, anger management, and sleep hygiene.

Transition

After the last patient was discharged from JNYMS in May 2020, personnel were quickly redeployed to their duty stations. At the time of mission completion, the JNYMS behavioral health team had been supplemented with psychiatrists, social workers, behavioral health technicians, psychiatric nurse practitioners, psychiatric nurses, and psychologists representing US Public Health Service Commissioned Corps, Army, Air Force, and Navy, and provided comprehensive support to the nearly 1100 patients with COVID-19 and 600 deployed federal and state medical and support personnel.

Lessons Learned and Future Considerations

Behavioral health care provided at JNYMS offers insight into support of frontline workers in pandemic settings, as literature is limited in this area.¹³ TheJNYMS behavioral health team used strategies similar to military medical interventions in limited and unpredictable environments, such as rapid formalization of team structure and establishment of standard operating procedures to facilitate uniformity across interventions. Physical space was necessary to create an environment conducive to productive mental health interventions, including therapy rooms and quiet and spiritual spaces. Placing behavioral resources in high-traffic areas normalized mental health and maximized accessibility to interventions. Mental health personnel also addressed issues in the work environment, such as providing informal support and crisis interventions to frontline workers. Finally, Urban Augmentation Medical Task Forces mental health personnel and Combat Operational Stress Control units provided therapeutic interventions and resiliency training for military and civilian personnel throughout burdened medical systems beyond JNYMS.

Future operations should consider what equipment and logistic access are necessary to provide psychiatric and psychological care to mobilized federal and uniformed personnel, such as access to frontline worker electronic health records. Given that prior work has found that provision of resources alone is inadequate, frontline medical workers must be aware of where resources are available (eg, signage) and have easy access to material (eg, brochures) focusing on resiliency and psychological health.¹⁴ The spaces can be used for formal psychiatric and psychological interventions, such as assessment, therapy, and medication management. Equally important, these spaces serve as a safe place for healthy social interaction and fulfillment of basic needs (eg, nourishment) and a peaceful environment free of stimulation.

Since mental health personnel provide varied services ranging from basic human interaction to complex crisis interventions, mental health personnel should supplement pandemic medical operations. Evidence supports the notion that effective communication and cohesion throughout the entire leadership and health care team structure can improve resilience and implementation of mental health interventions.¹⁵ Incorporating mental health personnel into leadership planning meetings would allow for timely recommendations to improve medical logistics and planning of deployment of behavioral health resources. As a general rule, providing behavioral health experts with a seat at the table enhances advocacy and command awareness of the morale and mental health of frontline personnel.

Conclusions

We present the experience of developing mental health support services for deployed personnel during the COVID-19 pandemic and address the real-time mental health treatment and support of deployed uniformed services and federal personnel in the COVID-19 response environment. Timely and effective interventions included securing safe therapeutic space in high-traffic areas, developing relationships with leadership and frontline workers in their own work environments, and disseminating such services throughout the civilian medical system.

Mental health supplementation during the medical response mission strengthened morale in frontline workers in a disaster scenario. We hope that this report and others like it will provide information to improve mental health responses, reinforce mental health support, and encourage research in evidence-based interventions in challenging pandemic and disaster settings.

Acknowledgments

We would like to acknowledge and thank those serving on the frontlines of the COVID-19 pandemic.

Higher industriousness was associated with a 25% reduced risk of concurrent motoric cognitive risk syndrome (MCR), based on data from approximately 6,000 individuals.

Previous research supports an association between conscientiousness and a lower risk of MCR, a form of predementia that involves slow gait speed and cognitive complaints, wrote Yannick Stephan, PhD, of the University of Montpellier (France), and colleagues. However, the specific facets of conscientiousness that impact MCR have not been examined.

In a study published in the Journal of Psychiatric Research, the authors reviewed data from 6,001 dementia-free adults aged 65-99 years who were enrolled in the Health and Retirement Study, a nationally representative longitudinal study of adults aged 50 years and older in the United States.

Baseline data were collected between 2008 and 2010, and participants were assessed for MCR at follow-up points during 2012-2014 and 2016-2018. Six facets of conscientiousness were assessed using a 24-item scale that has been used in previous studies. The six facets were industriousness, self-control, order, traditionalism, virtue, and responsibility. The researchers controlled for variables including demographic factors, cognition, physical activity, disease burden, depressive symptoms, and body mass index.

Overall, increased industriousness was significantly associated with a lower likelihood of concurrent MCR (odds ratio, 0.75) and a reduced risk of incident MCR (hazard ratio, 0.63,; P < .001 for both).

The conscientiousness facets of order, self-control, and responsibility also were associated with a lower likelihood of both concurrent and incident MCR, with ORs ranging from 0.82-0.88 for concurrent and HRs ranging from 0.72-0.82 for incident.

Traditionalism and virtue were significantly associated with a lower risk of incident MCR, but not concurrent MCR (HR, 0.84; P < .01 for both).

The mechanism of action for the association may be explained by several cognitive, health-related, behavioral, and psychological pathways, the researchers wrote. With regard to industriousness, the relationship could be partly explained by cognition, physical activity, disease burden, BMI, and depressive symptoms. However, industriousness also has been associated with a reduced risk of systemic inflammation, which may in turn reduce MCR risk. Also, data suggest that industriousness and MCR share a common genetic cause.

The study findings were limited by several factors including the observational design and the positive selection effect from patients with complete follow-up data, as these patients likely have higher levels of order, industriousness, and responsibility, the researchers noted. However, the results support those from previous studies and were strengthened by the large sample and examination of six facets of conscientiousness.

“This study thus provides a more detailed understanding of the specific components of conscientiousness that are associated with risk of MCR among older adults,” and the facets could be targeted in interventions to reduce both MCR and dementia, they concluded.

The Health and Retirement Study is supported by the National Institute on Aging and conducted by the University of Michigan. The current study was supported in part by the National Institutes of Health. The researchers had no financial conflicts to disclose.

Higher industriousness was associated with a 25% reduced risk of concurrent motoric cognitive risk syndrome (MCR), based on data from approximately 6,000 individuals.

Previous research supports an association between conscientiousness and a lower risk of MCR, a form of predementia that involves slow gait speed and cognitive complaints, wrote Yannick Stephan, PhD, of the University of Montpellier (France), and colleagues. However, the specific facets of conscientiousness that impact MCR have not been examined.

In a study published in the Journal of Psychiatric Research, the authors reviewed data from 6,001 dementia-free adults aged 65-99 years who were enrolled in the Health and Retirement Study, a nationally representative longitudinal study of adults aged 50 years and older in the United States.

Baseline data were collected between 2008 and 2010, and participants were assessed for MCR at follow-up points during 2012-2014 and 2016-2018. Six facets of conscientiousness were assessed using a 24-item scale that has been used in previous studies. The six facets were industriousness, self-control, order, traditionalism, virtue, and responsibility. The researchers controlled for variables including demographic factors, cognition, physical activity, disease burden, depressive symptoms, and body mass index.

Overall, increased industriousness was significantly associated with a lower likelihood of concurrent MCR (odds ratio, 0.75) and a reduced risk of incident MCR (hazard ratio, 0.63,; P < .001 for both).

The conscientiousness facets of order, self-control, and responsibility also were associated with a lower likelihood of both concurrent and incident MCR, with ORs ranging from 0.82-0.88 for concurrent and HRs ranging from 0.72-0.82 for incident.

Traditionalism and virtue were significantly associated with a lower risk of incident MCR, but not concurrent MCR (HR, 0.84; P < .01 for both).

The mechanism of action for the association may be explained by several cognitive, health-related, behavioral, and psychological pathways, the researchers wrote. With regard to industriousness, the relationship could be partly explained by cognition, physical activity, disease burden, BMI, and depressive symptoms. However, industriousness also has been associated with a reduced risk of systemic inflammation, which may in turn reduce MCR risk. Also, data suggest that industriousness and MCR share a common genetic cause.

The study findings were limited by several factors including the observational design and the positive selection effect from patients with complete follow-up data, as these patients likely have higher levels of order, industriousness, and responsibility, the researchers noted. However, the results support those from previous studies and were strengthened by the large sample and examination of six facets of conscientiousness.

“This study thus provides a more detailed understanding of the specific components of conscientiousness that are associated with risk of MCR among older adults,” and the facets could be targeted in interventions to reduce both MCR and dementia, they concluded.

The Health and Retirement Study is supported by the National Institute on Aging and conducted by the University of Michigan. The current study was supported in part by the National Institutes of Health. The researchers had no financial conflicts to disclose.

Higher industriousness was associated with a 25% reduced risk of concurrent motoric cognitive risk syndrome (MCR), based on data from approximately 6,000 individuals.

Previous research supports an association between conscientiousness and a lower risk of MCR, a form of predementia that involves slow gait speed and cognitive complaints, wrote Yannick Stephan, PhD, of the University of Montpellier (France), and colleagues. However, the specific facets of conscientiousness that impact MCR have not been examined.

In a study published in the Journal of Psychiatric Research, the authors reviewed data from 6,001 dementia-free adults aged 65-99 years who were enrolled in the Health and Retirement Study, a nationally representative longitudinal study of adults aged 50 years and older in the United States.

Baseline data were collected between 2008 and 2010, and participants were assessed for MCR at follow-up points during 2012-2014 and 2016-2018. Six facets of conscientiousness were assessed using a 24-item scale that has been used in previous studies. The six facets were industriousness, self-control, order, traditionalism, virtue, and responsibility. The researchers controlled for variables including demographic factors, cognition, physical activity, disease burden, depressive symptoms, and body mass index.

Overall, increased industriousness was significantly associated with a lower likelihood of concurrent MCR (odds ratio, 0.75) and a reduced risk of incident MCR (hazard ratio, 0.63,; P < .001 for both).

The conscientiousness facets of order, self-control, and responsibility also were associated with a lower likelihood of both concurrent and incident MCR, with ORs ranging from 0.82-0.88 for concurrent and HRs ranging from 0.72-0.82 for incident.

Traditionalism and virtue were significantly associated with a lower risk of incident MCR, but not concurrent MCR (HR, 0.84; P < .01 for both).

The mechanism of action for the association may be explained by several cognitive, health-related, behavioral, and psychological pathways, the researchers wrote. With regard to industriousness, the relationship could be partly explained by cognition, physical activity, disease burden, BMI, and depressive symptoms. However, industriousness also has been associated with a reduced risk of systemic inflammation, which may in turn reduce MCR risk. Also, data suggest that industriousness and MCR share a common genetic cause.

The study findings were limited by several factors including the observational design and the positive selection effect from patients with complete follow-up data, as these patients likely have higher levels of order, industriousness, and responsibility, the researchers noted. However, the results support those from previous studies and were strengthened by the large sample and examination of six facets of conscientiousness.

“This study thus provides a more detailed understanding of the specific components of conscientiousness that are associated with risk of MCR among older adults,” and the facets could be targeted in interventions to reduce both MCR and dementia, they concluded.

The Health and Retirement Study is supported by the National Institute on Aging and conducted by the University of Michigan. The current study was supported in part by the National Institutes of Health. The researchers had no financial conflicts to disclose.

The benefit of endovascular therapy in the treatment of stroke caused by an occlusion of the basilar artery has finally been confirmed in the ATTENTION randomized trial.

The study, conducted in China, showed that endovascular therapy for basilar artery occlusion is associated with higher rates of favorable and independent outcomes, as well as lower overall disability and lower mortality at 90 days, than best medical management alone.

The results were presented by Raul Nogueira, MD, professor of neurology at the University of Pittsburgh School of Medicine, at the European Stroke Organisation Conference (ESOC) 2022, where they were greeted with applause from the audience.

The number needed to treat was just four.

“There were no surprises with secondary endpoints; everything was highly statistically significant,” Dr. Nogueira said.

Specifically, there was a lower rate of overall disability in the shift analysis, with a common odds ratio of 2.8 favoring the intervention.  

Safety results showed an increased risk for symptomatic ICH in the endovascular group (5.3% vs. 0.0%) but, despite that, 90-day mortality was significantly lower in the endovascular group (36.7% vs. 55.3%).

Dr. Nogueira noted a limitation of the study was that it was conducted in China.

“This was a Chinese study and, as Asians are known to have higher rates of intracranial atherosclerotic disease, the overall degree of generalizability of our findings to Western countries needs to be considered,” he commented.

However, subgroup analysis showed no treatment effect modification based on the presence of intracranial atherosclerotic disease, he noted.

Also, the proportion of comorbidities in the ATTENTION trial was similar to that in the BASICS trial, with the same degree of diabetes and atrial fibrillation.

Dr. Nogueira concluded that, in contrast to previous randomized trials of endovascular treatment for basilar artery occlusion, the ATTENTION trial was able to reinforce consecutive enrollment, resulting in a fast recruitment while minimizing crossovers. 

Furthermore, he pointed out that the overall results are consistent with modern era observational studies, large registries, and meta-analysis.

Commenting on the study, Joanna Wardlaw, MD, professor of applied neuroimaging at the University of Edinburgh (Scotland), and chair of the ESOC Planning Group, said: “This is a very important result, since it provides confirmation beyond doubt the benefit of thrombectomy versus medical therapy for basilar artery occlusion stroke up to 12 hours after onset.”

Dr. Wardlaw added: “The trial was large enough to provide clear results and to enable subgroup analyses; no subgroup did not benefit from thrombectomy.”

In a discussion after the presentation, Urs Fischer, MD, chair of the department of neurology at the University Hospital Basel, Switzerland, said he was not surprised by the results of the ATTENTION trial.

“We have been doing thrombectomy in patients with basilar artery occlusion now for 20 years, although trials are extremely important to answer these questions, so now we have some clear evidence,” Dr. Fischer said. “Nevertheless, there are some caveats, as this is an Asian population, but this is a proof of concept, and it is going in the right direction.”

The ATTENTION trial was sponsored by the First Affiliated Hospital of University of Science and Technology of China.

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

The benefit of endovascular therapy in the treatment of stroke caused by an occlusion of the basilar artery has finally been confirmed in the ATTENTION randomized trial.

The study, conducted in China, showed that endovascular therapy for basilar artery occlusion is associated with higher rates of favorable and independent outcomes, as well as lower overall disability and lower mortality at 90 days, than best medical management alone.

The results were presented by Raul Nogueira, MD, professor of neurology at the University of Pittsburgh School of Medicine, at the European Stroke Organisation Conference (ESOC) 2022, where they were greeted with applause from the audience.

The number needed to treat was just four.

“There were no surprises with secondary endpoints; everything was highly statistically significant,” Dr. Nogueira said.

Specifically, there was a lower rate of overall disability in the shift analysis, with a common odds ratio of 2.8 favoring the intervention.  

Safety results showed an increased risk for symptomatic ICH in the endovascular group (5.3% vs. 0.0%) but, despite that, 90-day mortality was significantly lower in the endovascular group (36.7% vs. 55.3%).

Dr. Nogueira noted a limitation of the study was that it was conducted in China.

“This was a Chinese study and, as Asians are known to have higher rates of intracranial atherosclerotic disease, the overall degree of generalizability of our findings to Western countries needs to be considered,” he commented.

However, subgroup analysis showed no treatment effect modification based on the presence of intracranial atherosclerotic disease, he noted.

Also, the proportion of comorbidities in the ATTENTION trial was similar to that in the BASICS trial, with the same degree of diabetes and atrial fibrillation.

Dr. Nogueira concluded that, in contrast to previous randomized trials of endovascular treatment for basilar artery occlusion, the ATTENTION trial was able to reinforce consecutive enrollment, resulting in a fast recruitment while minimizing crossovers. 

Furthermore, he pointed out that the overall results are consistent with modern era observational studies, large registries, and meta-analysis.

Commenting on the study, Joanna Wardlaw, MD, professor of applied neuroimaging at the University of Edinburgh (Scotland), and chair of the ESOC Planning Group, said: “This is a very important result, since it provides confirmation beyond doubt the benefit of thrombectomy versus medical therapy for basilar artery occlusion stroke up to 12 hours after onset.”

Dr. Wardlaw added: “The trial was large enough to provide clear results and to enable subgroup analyses; no subgroup did not benefit from thrombectomy.”

In a discussion after the presentation, Urs Fischer, MD, chair of the department of neurology at the University Hospital Basel, Switzerland, said he was not surprised by the results of the ATTENTION trial.

“We have been doing thrombectomy in patients with basilar artery occlusion now for 20 years, although trials are extremely important to answer these questions, so now we have some clear evidence,” Dr. Fischer said. “Nevertheless, there are some caveats, as this is an Asian population, but this is a proof of concept, and it is going in the right direction.”

The ATTENTION trial was sponsored by the First Affiliated Hospital of University of Science and Technology of China.

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

The benefit of endovascular therapy in the treatment of stroke caused by an occlusion of the basilar artery has finally been confirmed in the ATTENTION randomized trial.

The study, conducted in China, showed that endovascular therapy for basilar artery occlusion is associated with higher rates of favorable and independent outcomes, as well as lower overall disability and lower mortality at 90 days, than best medical management alone.

The results were presented by Raul Nogueira, MD, professor of neurology at the University of Pittsburgh School of Medicine, at the European Stroke Organisation Conference (ESOC) 2022, where they were greeted with applause from the audience.

The number needed to treat was just four.

“There were no surprises with secondary endpoints; everything was highly statistically significant,” Dr. Nogueira said.

Specifically, there was a lower rate of overall disability in the shift analysis, with a common odds ratio of 2.8 favoring the intervention.  

Safety results showed an increased risk for symptomatic ICH in the endovascular group (5.3% vs. 0.0%) but, despite that, 90-day mortality was significantly lower in the endovascular group (36.7% vs. 55.3%).

Dr. Nogueira noted a limitation of the study was that it was conducted in China.

“This was a Chinese study and, as Asians are known to have higher rates of intracranial atherosclerotic disease, the overall degree of generalizability of our findings to Western countries needs to be considered,” he commented.

However, subgroup analysis showed no treatment effect modification based on the presence of intracranial atherosclerotic disease, he noted.

Also, the proportion of comorbidities in the ATTENTION trial was similar to that in the BASICS trial, with the same degree of diabetes and atrial fibrillation.

Dr. Nogueira concluded that, in contrast to previous randomized trials of endovascular treatment for basilar artery occlusion, the ATTENTION trial was able to reinforce consecutive enrollment, resulting in a fast recruitment while minimizing crossovers. 

Furthermore, he pointed out that the overall results are consistent with modern era observational studies, large registries, and meta-analysis.

Commenting on the study, Joanna Wardlaw, MD, professor of applied neuroimaging at the University of Edinburgh (Scotland), and chair of the ESOC Planning Group, said: “This is a very important result, since it provides confirmation beyond doubt the benefit of thrombectomy versus medical therapy for basilar artery occlusion stroke up to 12 hours after onset.”

Dr. Wardlaw added: “The trial was large enough to provide clear results and to enable subgroup analyses; no subgroup did not benefit from thrombectomy.”

In a discussion after the presentation, Urs Fischer, MD, chair of the department of neurology at the University Hospital Basel, Switzerland, said he was not surprised by the results of the ATTENTION trial.

“We have been doing thrombectomy in patients with basilar artery occlusion now for 20 years, although trials are extremely important to answer these questions, so now we have some clear evidence,” Dr. Fischer said. “Nevertheless, there are some caveats, as this is an Asian population, but this is a proof of concept, and it is going in the right direction.”

The ATTENTION trial was sponsored by the First Affiliated Hospital of University of Science and Technology of China.

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