From the Senior Health Program, Providence Health & Services, Oregon, Portland, OR.

Abstract

Background: Approximately 51 million adults in the United States are 65 years of age or older, yet few geriatric-trained primary care providers (PCP) serve this population. The Age-Friendly Health System framework, consisting of evidence-based 4M care (Mobility, Medication, Mentation, and what Matters), encourages all PCPs to assess mobility in older adults.

Objective: To improve PCP knowledge, confidence, and clinical practice in assessing and managing fall risk.

Methods: A 1-week educational session focusing on mobility (part of a 4-week Geriatric Mini-Fellowship) for 6 selected PCPs from a large health care system was conducted to increase knowledge and ability to address fall risk in older adults. The week included learning and practicing a Fall Risk Management Plan (FRMP) algorithm, including planning for their own practice changes. Pre- and post-test surveys assessed changes in knowledge and confidence. Patient data were compared 12 months before and after training to evaluate PCP adoption of FRMP components.

Results: The training increased provider knowledge and confidence. The trained PCPs were 1.7 times more likely to screen for fall risk; 3.6 times more likely to discuss fall risk; and 5.8 times more likely to assess orthostatic blood pressure in their 65+ patients after the mini-fellowship. In high-risk patients, they were 4.1 times more likely to discuss fall risk and 6.3 times more likely to assess orthostatic blood pressure than their nontrained peers. Changes in physical therapy referral rates were not observed.

Conclusions: In-depth, skills-based geriatric educational sessions improved PCPs’ knowledge and confidence and also improved their fall risk management practices for their older patients.

Keywords: geriatrics; guidelines; Age-Friendly Health System; 4M; workforce training; practice change; fellowship.

The US population is aging rapidly. People aged 85 years and older are the largest-growing segment of the US population, and this segment is expected to increase by 123% by 2040.¹ Caregiving needs increase with age as older adults develop more chronic conditions, such as hypertension, heart disease, arthritis, and dementia. However, even with increasing morbidity and dependence, a majority of older adults still live in the community rather than in institutional settings.² These older adults seek medical care more frequently than younger people, with about 22% of patients 75 years and older having 10 or more health care visits in the previous 12 months. By 2040, nearly a quarter of the US population is expected to be 65 or older, with many of these older adults seeking regular primary care from providers who do not have formal training in the care of a population with multiple complex, chronic health conditions and increased caregiving needs.¹

Despite this growing demand for health care professionals trained in the care of older adults, access to these types of clinicians is limited. In 2018, there were roughly 7000 certified geriatricians, with only 3600 of them practicing full-time.^3,4 Similarly, of 290,000 certified nurse practitioners (NPs), about 9% of them have geriatric certification.⁵ Geriatricians, medical doctors trained in the care of older adults, and geriatric-trained NPs are part of a cadre of a geriatric-trained workforce that provides unique expertise in caring for older adults with chronic and advanced illness. They know how to manage multiple, complex geriatric syndromes like falls, dementia, and polypharmacy; understand and maximize team-based care; and focus on caring for an older person with a goal-centered versus a disease-centered approach.⁶

Broadly, geriatric care includes a spectrum of adults, from those who are aging healthfully to those who are the frailest. Research has suggested that approximately 30% of older adults need care by a geriatric-trained clinician, with the oldest and frailest patients needing more clinician time for assessment and treatment, care coordination, and coaching of caregivers.⁷ With this assumption in mind, it is projected that by 2025, there will be a national shortage of 26,980 geriatricians, with the western United States disproportionately affected by this shortage.⁴Rather than lamenting this shortage, Tinetti recommends a new path forward: “Our mission should not be to train enough geriatricians to provide direct care, but rather to ensure that every clinician caring for older adults is competent in geriatric principles and practices.”⁸ Sometimes called ”geriatricizing,” the idea is to use existing geriatric providers as a small elite training force to infuse geriatric principles and skills across their colleagues in primary care and other disciplines.^8,9 Efforts of the American Geriatrics Society (AGS), with support from the John A. Hartford Foundation (JAHF), have been successful in developing geriatric training across multiple specialties, including surgery, orthopedics, and emergency medicine (www.americangeriatrics.org/programs/geriatrics-specialists-initiative).

The Age-Friendly Health System and 4M Model

To help augment this idea of equipping health care systems and their clinicians with more readily available geriatric knowledge, skills, and tools, the JAHF, along with the Institute for Healthcare Improvement (IHI), created the Age-Friendly Health System (AFHS) paradigm in 2015.¹⁰ Using the 4M model, the AFHS initiative established a set of evidence-based geriatric priorities and interventions meant to improve the care of older adults, reduce harm and duplication, and provide a framework for engaging leadership, clinical teams, and operational systems across inpatient and ambulatory settings.¹¹ Mobility, including fall risk screening and intervention, is 1 of the 4M foundational elements of the Age-Friendly model. In addition to Mobility, the 4M model also includes 3 other key geriatric domains: Mentation (dementia, depression, and delirium), Medication (high-risk medications, polypharmacy, and deprescribing), and What Matters (goals of care conversations and understanding quality of life for older patients).¹¹ The 4M initiative encourages adoption of a geriatric lens that looks across chronic conditions and accounts for the interplay among geriatric syndromes, such as falls, cognitive impairment, and frailty, in order to provide care better tailored to what the patient needs and desires.¹² IHI and JAHF have targeted the adoption of the 4M model by 20% of US health care systems by 2020.¹¹

Mini-Fellowship and Mobility Week

To bolster geriatric skills among community-based primary care providers (PCPs), we initiated a Geriatric Mini-Fellowship, a 4-week condensed curriculum taught over 6 months. Each week focuses on 1 of the age-friendly 4Ms, with the goal of increasing the knowledge, self-efficacy, skills, and competencies of the participating PCPs (called “fellow” hereafter) and at the same time, equipping each to become a champion of geriatric practice. This article focuses on the Mobility week, the second week of the mini-fellowship, and the effect of the week on the fellows’ practice changes.

To construct the Mobility week’s curriculum with a focus on the ambulatory setting, we relied upon national evidence-based work in fall risk management. The Centers for Disease Control and Prevention (CDC) has made fall risk screening and management in primary care a high priority. Using the clinical practice guidelines for managing fall risk developed by the American and British Geriatrics Societies (AGS/BGS), the CDC developed the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) toolkit.¹³ Foundational to the toolkit is the validated 12-item Stay Independent falls screening questionnaire (STEADI questionnaire).¹⁴ Patients who score 4 or higher (out of a total score of 14) on the questionnaire are considered at increased risk of falling. The CDC has developed a clinical algorithm that guides clinical teams through screening and assessment to help identify appropriate interventions to target specific risk factors. Research has clearly established that a multifactorial approach to fall risk intervention can be successful in reducing fall risk by as much as 25%.^15-17

The significant morbidity and mortality caused by falls make training nongeriatrician clinicians on how to better address fall risk imperative. More than 25% of older adults fall each year.¹⁸ These falls contribute to rising rates of fall-related deaths,¹⁹ emergency department (ED) visits,²⁰ and hospital readmissions.²¹ Initiatives like the AFHS focus on mobility and the CDC’s development of supporting clinical materials²² aim to improve primary care adoption of fall risk screening and intervention practices.^23,24 The epidemic of falls must compel all PCPs, not just those practicing geriatrics, to make discussing and addressing fall risk and falls a priority.

Methods

Setting

This project took place as part of a regional primary care effort in Oregon. Providence Health & Services-Oregon is part of a multi-state integrated health care system in the western United States whose PCPs serve more than 80,000 patients aged 65 years and older per year; these patients comprise 38% of the system’s office visits each year. Regionally, there are 47 family and internal medicine clinics employing roughly 290 providers (physicians, NPs, and physician assistants). The organization has only 4 PCPs trained in geriatrics and does not offer any geriatric clinical consultation services. Six PCPs from different clinics, representing both rural and urban settings, are chosen to participate in the geriatric mini-fellowship each year.

This project was conducted as a quality improvement initiative within the organization and did not constitute human subjects research. It was not conducted under the oversight of the Institutional Review Board.

Intervention

The mini-fellowship was taught in 4 1-week blocks between April and October 2018, with a curriculum designed to be interactive and practical. The faculty was intentionally interdisciplinary to teach and model team-based practice. Each week participants were excused from their clinical practice. Approximately 160 hours of continuing medical education credits were awarded for the full mini-fellowship. As part of each weekly session, a performance improvement project (PIP) focused on that week’s topic (1 of the 4Ms) was developed by the fellow and their team members to incorporate the mini-fellowship learnings into their clinic workflows. Fellows also had 2 hours per week of dedicated administration time for a year, outside the fellowship, to work on their PIP and 4M practice changes within their clinic.

Provider Education

The week for mobility training comprised 4 daylong sessions. The first 2 days were spent learning about the epidemiology of falls; risk factors for falling; how to conduct a thorough history and assessment of fall risk; and how to create a prioritized Fall Risk Management Plan (FRMP) to decrease a patient’s individual fall risk through tailored interventions. The FRMP was adapted from the CDC STEADI toolkit.¹³ Core faculty were 2 geriatric-trained providers (NP and physician) and a physical therapist (PT) specializing in fall prevention.

On the third day, fellows took part in a simulated fall risk clinic, in which older adults volunteered to be patient partners, providing an opportunity to apply learnings from days 1 and 2. The clinic included the fellow observing a PT complete a mobility assessment and a pharmacist conduct a high-risk medication review. The fellow synthesized the findings of the mobility assessment and medication review, as well as their own history and assessment, to create a summary of fall risk recommendations to discuss with their volunteer patient partner. The fellows were observed and evaluated in their skills by their patient partner, course faculty, and another fellow. The patient partners, and their assigned fellow, also participated in a 45-minute fall risk presentation, led by a nurse.

On the fourth day, the fellows were joined by select clinic partners, including nurses, pharmacists, and/or medical assistants. The session included discussions among each fellow’s clinical team regarding the current state of fall risk efforts at their clinic, an analysis of barriers, and identification of opportunities to improve workflows and screening rates. Each fellow took with them an action plan tailored to their clinic to improve fall risk management practices, starting with the fellow’s own practice.

Fall Risk Management Plan

The educational sessions introduced the fellows to the FRMP. The FRMP, adapted from the STEADI toolkit, includes a process for fall risk screening (Figure 1) and stratifying a patient’s risk based on their STEADI score in order to promote 3 priority assessments (gait evaluation with PT referral if appropriate; orthostatic blood pressure; and high-risk medication review; Figure 2). Initial actions based on these priority assessments were followed over time, with additional fall risk interventions added as clinically indicated.²⁵ The FRMP is intended to be used during routine office visits, Medicare annual wellness visits, or office visits focused on fall risk or related medical disorders (ie, fall risk visits.)

Providers and their teams were encouraged to spread out fall-related conversations with their patients over multiple visits, since many patients have multiple fall risk factors at play, in addition to other chronic medical issues, and since many interventions often require behavior changes on the part of the patient. Providers also had access to fall-related electronic health record (EHR) templates as well as a comprehensive, internal fall risk management website that included assessment tools, evidence-based resources, and patient handouts.

Assessment and Measurements

We assessed provider knowledge and comfort in their fall risk evaluation and management skills before and after the educational intervention using an 11-item multiple-choice questionnaire and a 4-item confidence questionnaire. The confidence questions used a 7-point Likert scale, with 0 indicating “no confidence” and 7 indicating ”lots of confidence.” The questions were administered via a paper survey. Qualitative comments were derived from evaluations completed at the end of the week.

The fellows’ practice of fall risk screening and management was studied from May 2018, at the completion of Mobility week, to May 2019 for the post-intervention period. A 1-year timeframe before May 2018 was used as the pre-intervention period. Eligible visit types, during which we assumed fall risk was discussed, were any office visits for patients 65+ completed by the patients’ PCPs that used fall risk as a reason for the visit or had a fall-related diagnosis code. Fall risk visits performed by other clinic providers were not counted.

Of those patients who had fall risk screenings completed and were determined to be high risk (STEADI score ≥ 4), data were analyzed to determine whether these patients had any fall-related follow-up visits to their PCP within 60 days of the STEADI screening. For these high-risk patients, data were studied to understand whether orthostatic blood pressure measurements were performed (as documented in a flowsheet) and whether a PT referral was placed. These data were compared with those from providers who practiced in clinics within the same system but who did not participate in the mini-fellowship. Data were obtained from the organization’s EHR. Additional data were measured to evaluate patterns of deprescribing of select high-risk medications, but these data are not included in this analysis.

Analysis

A paired-samples t test was used to measure changes in provider confidence levels. Data were aggregated across fellows, resulting in a mean. A chi-square test of independence was performed to examine the relationship between rates of FRMP adoption by select provider groups. Analysis included a pre- and post-intervention assessment of the fellows’ adoption of FRMP practices, as well as a comparison between the fellows’ practice patterns and those of a control group of PCPs in the organization’s other clinics who did not participate in the mini-fellowship (nontrained control group). Excluded from the control group were providers from the same clinic as the fellows; providers in clinics with a geriatric-trained provider on staff; and clinics outside of the Portland metro and Medford service areas. We used an alpha level of 0.05 for all statistical tests.

Data from 5 providers were included in the analysis of the FRMP adoption. The sixth provider changed practice settings from the clinic to the ED after completing the fellowship; her patient data were not included in the FRMP part of the analysis. EHR data included data on all visits of patients 65+, as well as data for just those 65+ patients who had been identified as being at high risk to fall based on a STEADI score of 4 or higher.

Results

Provider Questionnaire

All 6 providers responded to the pre-intervention and post-intervention tests. For the knowledge questions, fellows, as a composite, correctly answered 57% of the questions before the intervention and 79% after the intervention. Provider confidence level in delivering fall risk care was measured prior to the training (mean, 4.12 [SD, 0.62]) and at the end of the training (mean, 6.47 [SD, 0.45]), demonstrating a significant increase in confidence (t (5) = –10.46, P < 0.001).

Qualitative Comments

Providers also had the opportunity to provide comments on their experience during the Mobility week and at the end of 1 year. In general, the simulated interdisciplinary fall risk clinic was highly rated (“the highlight of the week”) as a practical strategy to embed learning principles. One fellow commented, “Putting the learning into practice helps solidify it in my brain.” Fellows also appreciated the opportunity to learn and meet with their clinic colleagues to begin work on a fall-risk focused PIP and to “have a framework for what to do for people who screen positive [for fall risk].”

FRMP Adoption

A comparison of the care the fellows provided to their patients 65+ in the 12 months pre- and post-training shows the fellows demonstrated significant changes in practice patterns. The fellows were 1.7 times more likely to screen for fall risk; 3.6 times more likely to discuss fall risk; and 5.8 times more likely to check orthostatic blood pressure than prior to the mini-fellowship (Table 1).

The control providers also demonstrated significant increases in fall risk screening and discussion of fall risk between the pre- and post-intervention periods; however, the relative risk (RR) was between 1.10 and 1.13 for this group. For the control group, checking orthostatic blood pressure did not significantly change. In the 12 months after training (Table 2), the fellows were 4.2 times more likely to discuss fall risk and almost 5 times more likely to check orthostatic blood pressure than their nontrained peers for all of their patients 65+, regardless of their risk to fall.

As shown in Table 3, for those patients determined to be at high risk of falling (STEADI score ≥ 4), fellows showed statistically significant increases in fall risk visits (RR, 3.02) and assessment of orthostatic blood pressure (RR, 10.68) before and after the mini-fellowship. The control providers did not show any changes in practice patterns between the pre- and post-period among patients at high risk to fall.

Neither the fellows nor the control group showed changes in patterns of referral to PT. In comparing the 2 groups in the 12 months after training (Table 4), for their patients at risk of falling, the fellows were 4 times more likely to complete fall risk visits and over 6 times more likely to assess orthostatic blood pressure than their nontrained peers. Subgroup analysis of the 75+ population revealed similar trends and significance, but these results are not included here.

Discussion

This study aimed to improve not only providers’ knowledge and confidence in caring for older adults at increased risk to fall, but also their clinical practice in assessing and managing fall risk. In addition to improved knowledge and confidence, we found that the fellows increased their discussion of fall risk (through fall risk visits) and their assessment of orthostatic blood pressure for all of their patients, not just for those identified at increased risk to fall. This improvement held true for the fellows themselves before and after the intervention, but also as compared to their nontrained peers. These practice improvements for all of their 65+ patients, not just those identified as being at high risk to fall, are especially important, since studies indicate that early screening and intervention can help identify people at risk and prevent future falls.¹⁵

We were surprised that there were no significant differences in PT referrals made by the trained fellows, but this finding may have been confounded by the fact that the data included all PT referrals, regardless of diagnosis, not just those referrals that were fall-related. Furthermore, our baseline PT referral rates, at 39% for the intervention group and 42% for the control group, are higher than national data when looking at rehabilitation use by older adults.²⁶

In comparison to a study evaluating the occurrence of fall risk–related clinical practice in primary care before any fall-related educational intervention, orthostatics were checked less frequently in our study (10% versus 30%) and there were fewer PT referrals (42%–44% versus 53%).²⁷ However, the Phelan study took place in patients who had actually had a fall, rather than just having a higher risk for a fall, and was based on detailed chart review. Other studies^23,24 found higher rates of fall risk interventions, but did not break out PT referrals specifically.

In terms of the educational intervention itself, most studies of geriatric education interventions have measured changes in knowledge, confidence, or self-efficacy as they relate to geriatric competence,^28-30 and do not measure practice change as an outcome outside of intent to change or self-reported practice change.^31,32 In general, practice change or longer-term health care–related outcomes have not been studied. Additionally, a range of dosages of educational interventions has been studied, from 1-hour lunchtime presentations^23,32 to half-day²⁹ or several half-day workshops,²⁸ up to 160 hours over 10 months³⁰ or 5 weekends over 6 months.³¹ The duration of our entire intervention at 160 hours over 6 months would be considered on the upper end of dosing relative to these studies, with our Mobility week intervention comprising 32 hours during 1 week. In the Warshaw study, despite 107 1-hour sessions being taught to over 60 physicians in 16 practices over 4 years, only 2 practices ultimately initiated any practice change projects.³² We believe that only curricula that embed practice change skills and opportunities, at a significant enough dose, can actually impact practice change in a sustainable manner.

Knowledge and skill acquisition among individual providers does not take place to a sufficient degree in the current health care arena, which is focused on productivity and short visit times. Consistent with other studies, we included interdisciplinary members of the primary care team for part of the mini-fellowship, although other studies used models that train across disciplines for the entirety of the learning experience.^28-30,33 Our educational model was strengthened by including other professionals to provide some of the education and model the ideal geriatric team, including PT, occupational therapy, and pharmacy, for the week on mobility.

Most studies exploring interventions through geriatric educational initiatives are conducted within academic institutions, with a primary focus on physician faculty and, by extension, their teaching of residents and others.^34,35 We believe our integrated model, which is steeped in community-based primary care practices like Lam’s,³¹ offers the greatest outreach to large community-based care systems and their patients. Training providers to work with their teams to change their own practices first gives skills and expertise that help further establish them as geriatric champions within their practices, laying the groundwork for more widespread practice change at their clinics.

Limitations

In addition to the limitations described above relating to the capture of PT referrals, other limitations included the relatively short time period for follow-up data as well as the small size of the intervention group. However, we found value in the instructional depth that the small group size allowed.

While the nontrained providers did show some improvement during the same period, we believe the relative risk was not clinically significant. We suspect that the larger health system efforts to standardize screening of patients 65+ across all clinics as a core quality metric confounded these results. The data analysis also included only fall-related patient visits that occurred with a provider who was that patient’s PCP, which could have missed visits done by other PCP colleagues, RNs, or pharmacists in the same clinic, thus undercounting the true number of fall-related visits. Furthermore, counting of fall-related interventions relied upon providers documenting consistently in the EHR, which could also lead to under-represention of fall risk clinical efforts.

The data presented, while encouraging, do not reflect clinic-wide practice change patterns and are considered only proximate outcomes rather than more long-term or cost-related outcomes, as would be captured by fall-related utilization measures like emergency room visits and hospitalizations. We expect to evaluate the broader impact and these value-based outcomes in the future. All providers and teams were from the same health care system, which may not allow our results to transfer to other organizations or regions of clinical practice.

Summary

This study demonstrates that an intensive mini-fellowship model of geriatrics training improved both knowledge and confidence in the realm of fall risk assessment and intervention among PCPs who had not been formally trained in geriatrics. More importantly, the training improved the fall-related care of their patients at increased risk to fall, but also of all of their older patients, with improvements in care measured up to a year after the mini-fellowship. Although this article only describes the work done as part of the Mobility aim of the 4M AFHS model, we believe the entire mini-fellowship curriculum offers the opportunity to “geriatricize” clinicians and their teams in learning geriatric principles and skills that they can translate into their practice in a sustainable way, as Tinetti encourages.⁸ Future study to evaluate other process outcomes more precisely, such as PT, as well as cost- and value-based outcomes, and the influence of trained providers on their clinic partners, will further establish the value proposition of targeted, disseminated, intensive geriatrics training of primary care clinicians as a strategy of age-friendly health systems as they work to improve the care of their older adults.

Acknowledgment: We are grateful for the dedication and hard work of the 2018 Geriatric Mini-Fellowship fellows at Providence Health & Services-Oregon who made this article possible. Thanks to Drs. Stephanie Cha, Emily Puukka-Clark, Laurie Dutkiewicz, Cara Ellis, Deb Frost, Jordan Roth, and Subhechchha Shah for promoting the AFHS work within their Providence Medical Group clinics and to PMG leadership and the fellows’ clinical teams for supporting the fellows, the AFHS work, and their older patients.

Corresponding author: Colleen M. Casey, PhD, ANP-BC, Providence Health & Services, Senior Health Program, 4400 NE Halsey, 5th Floor, Portland, OR 97213; [email protected].

Financial disclosures: None.

From the Senior Health Program, Providence Health & Services, Oregon, Portland, OR.

Abstract

Background: Approximately 51 million adults in the United States are 65 years of age or older, yet few geriatric-trained primary care providers (PCP) serve this population. The Age-Friendly Health System framework, consisting of evidence-based 4M care (Mobility, Medication, Mentation, and what Matters), encourages all PCPs to assess mobility in older adults.

Objective: To improve PCP knowledge, confidence, and clinical practice in assessing and managing fall risk.

Methods: A 1-week educational session focusing on mobility (part of a 4-week Geriatric Mini-Fellowship) for 6 selected PCPs from a large health care system was conducted to increase knowledge and ability to address fall risk in older adults. The week included learning and practicing a Fall Risk Management Plan (FRMP) algorithm, including planning for their own practice changes. Pre- and post-test surveys assessed changes in knowledge and confidence. Patient data were compared 12 months before and after training to evaluate PCP adoption of FRMP components.

Results: The training increased provider knowledge and confidence. The trained PCPs were 1.7 times more likely to screen for fall risk; 3.6 times more likely to discuss fall risk; and 5.8 times more likely to assess orthostatic blood pressure in their 65+ patients after the mini-fellowship. In high-risk patients, they were 4.1 times more likely to discuss fall risk and 6.3 times more likely to assess orthostatic blood pressure than their nontrained peers. Changes in physical therapy referral rates were not observed.

Conclusions: In-depth, skills-based geriatric educational sessions improved PCPs’ knowledge and confidence and also improved their fall risk management practices for their older patients.

Keywords: geriatrics; guidelines; Age-Friendly Health System; 4M; workforce training; practice change; fellowship.

The US population is aging rapidly. People aged 85 years and older are the largest-growing segment of the US population, and this segment is expected to increase by 123% by 2040.¹ Caregiving needs increase with age as older adults develop more chronic conditions, such as hypertension, heart disease, arthritis, and dementia. However, even with increasing morbidity and dependence, a majority of older adults still live in the community rather than in institutional settings.² These older adults seek medical care more frequently than younger people, with about 22% of patients 75 years and older having 10 or more health care visits in the previous 12 months. By 2040, nearly a quarter of the US population is expected to be 65 or older, with many of these older adults seeking regular primary care from providers who do not have formal training in the care of a population with multiple complex, chronic health conditions and increased caregiving needs.¹

Despite this growing demand for health care professionals trained in the care of older adults, access to these types of clinicians is limited. In 2018, there were roughly 7000 certified geriatricians, with only 3600 of them practicing full-time.^3,4 Similarly, of 290,000 certified nurse practitioners (NPs), about 9% of them have geriatric certification.⁵ Geriatricians, medical doctors trained in the care of older adults, and geriatric-trained NPs are part of a cadre of a geriatric-trained workforce that provides unique expertise in caring for older adults with chronic and advanced illness. They know how to manage multiple, complex geriatric syndromes like falls, dementia, and polypharmacy; understand and maximize team-based care; and focus on caring for an older person with a goal-centered versus a disease-centered approach.⁶

Broadly, geriatric care includes a spectrum of adults, from those who are aging healthfully to those who are the frailest. Research has suggested that approximately 30% of older adults need care by a geriatric-trained clinician, with the oldest and frailest patients needing more clinician time for assessment and treatment, care coordination, and coaching of caregivers.⁷ With this assumption in mind, it is projected that by 2025, there will be a national shortage of 26,980 geriatricians, with the western United States disproportionately affected by this shortage.⁴Rather than lamenting this shortage, Tinetti recommends a new path forward: “Our mission should not be to train enough geriatricians to provide direct care, but rather to ensure that every clinician caring for older adults is competent in geriatric principles and practices.”⁸ Sometimes called ”geriatricizing,” the idea is to use existing geriatric providers as a small elite training force to infuse geriatric principles and skills across their colleagues in primary care and other disciplines.^8,9 Efforts of the American Geriatrics Society (AGS), with support from the John A. Hartford Foundation (JAHF), have been successful in developing geriatric training across multiple specialties, including surgery, orthopedics, and emergency medicine (www.americangeriatrics.org/programs/geriatrics-specialists-initiative).

The Age-Friendly Health System and 4M Model

To help augment this idea of equipping health care systems and their clinicians with more readily available geriatric knowledge, skills, and tools, the JAHF, along with the Institute for Healthcare Improvement (IHI), created the Age-Friendly Health System (AFHS) paradigm in 2015.¹⁰ Using the 4M model, the AFHS initiative established a set of evidence-based geriatric priorities and interventions meant to improve the care of older adults, reduce harm and duplication, and provide a framework for engaging leadership, clinical teams, and operational systems across inpatient and ambulatory settings.¹¹ Mobility, including fall risk screening and intervention, is 1 of the 4M foundational elements of the Age-Friendly model. In addition to Mobility, the 4M model also includes 3 other key geriatric domains: Mentation (dementia, depression, and delirium), Medication (high-risk medications, polypharmacy, and deprescribing), and What Matters (goals of care conversations and understanding quality of life for older patients).¹¹ The 4M initiative encourages adoption of a geriatric lens that looks across chronic conditions and accounts for the interplay among geriatric syndromes, such as falls, cognitive impairment, and frailty, in order to provide care better tailored to what the patient needs and desires.¹² IHI and JAHF have targeted the adoption of the 4M model by 20% of US health care systems by 2020.¹¹

Mini-Fellowship and Mobility Week

To bolster geriatric skills among community-based primary care providers (PCPs), we initiated a Geriatric Mini-Fellowship, a 4-week condensed curriculum taught over 6 months. Each week focuses on 1 of the age-friendly 4Ms, with the goal of increasing the knowledge, self-efficacy, skills, and competencies of the participating PCPs (called “fellow” hereafter) and at the same time, equipping each to become a champion of geriatric practice. This article focuses on the Mobility week, the second week of the mini-fellowship, and the effect of the week on the fellows’ practice changes.

To construct the Mobility week’s curriculum with a focus on the ambulatory setting, we relied upon national evidence-based work in fall risk management. The Centers for Disease Control and Prevention (CDC) has made fall risk screening and management in primary care a high priority. Using the clinical practice guidelines for managing fall risk developed by the American and British Geriatrics Societies (AGS/BGS), the CDC developed the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) toolkit.¹³ Foundational to the toolkit is the validated 12-item Stay Independent falls screening questionnaire (STEADI questionnaire).¹⁴ Patients who score 4 or higher (out of a total score of 14) on the questionnaire are considered at increased risk of falling. The CDC has developed a clinical algorithm that guides clinical teams through screening and assessment to help identify appropriate interventions to target specific risk factors. Research has clearly established that a multifactorial approach to fall risk intervention can be successful in reducing fall risk by as much as 25%.^15-17

The significant morbidity and mortality caused by falls make training nongeriatrician clinicians on how to better address fall risk imperative. More than 25% of older adults fall each year.¹⁸ These falls contribute to rising rates of fall-related deaths,¹⁹ emergency department (ED) visits,²⁰ and hospital readmissions.²¹ Initiatives like the AFHS focus on mobility and the CDC’s development of supporting clinical materials²² aim to improve primary care adoption of fall risk screening and intervention practices.^23,24 The epidemic of falls must compel all PCPs, not just those practicing geriatrics, to make discussing and addressing fall risk and falls a priority.

Methods

Setting

This project took place as part of a regional primary care effort in Oregon. Providence Health & Services-Oregon is part of a multi-state integrated health care system in the western United States whose PCPs serve more than 80,000 patients aged 65 years and older per year; these patients comprise 38% of the system’s office visits each year. Regionally, there are 47 family and internal medicine clinics employing roughly 290 providers (physicians, NPs, and physician assistants). The organization has only 4 PCPs trained in geriatrics and does not offer any geriatric clinical consultation services. Six PCPs from different clinics, representing both rural and urban settings, are chosen to participate in the geriatric mini-fellowship each year.

This project was conducted as a quality improvement initiative within the organization and did not constitute human subjects research. It was not conducted under the oversight of the Institutional Review Board.

Intervention

The mini-fellowship was taught in 4 1-week blocks between April and October 2018, with a curriculum designed to be interactive and practical. The faculty was intentionally interdisciplinary to teach and model team-based practice. Each week participants were excused from their clinical practice. Approximately 160 hours of continuing medical education credits were awarded for the full mini-fellowship. As part of each weekly session, a performance improvement project (PIP) focused on that week’s topic (1 of the 4Ms) was developed by the fellow and their team members to incorporate the mini-fellowship learnings into their clinic workflows. Fellows also had 2 hours per week of dedicated administration time for a year, outside the fellowship, to work on their PIP and 4M practice changes within their clinic.

Provider Education

The week for mobility training comprised 4 daylong sessions. The first 2 days were spent learning about the epidemiology of falls; risk factors for falling; how to conduct a thorough history and assessment of fall risk; and how to create a prioritized Fall Risk Management Plan (FRMP) to decrease a patient’s individual fall risk through tailored interventions. The FRMP was adapted from the CDC STEADI toolkit.¹³ Core faculty were 2 geriatric-trained providers (NP and physician) and a physical therapist (PT) specializing in fall prevention.

On the third day, fellows took part in a simulated fall risk clinic, in which older adults volunteered to be patient partners, providing an opportunity to apply learnings from days 1 and 2. The clinic included the fellow observing a PT complete a mobility assessment and a pharmacist conduct a high-risk medication review. The fellow synthesized the findings of the mobility assessment and medication review, as well as their own history and assessment, to create a summary of fall risk recommendations to discuss with their volunteer patient partner. The fellows were observed and evaluated in their skills by their patient partner, course faculty, and another fellow. The patient partners, and their assigned fellow, also participated in a 45-minute fall risk presentation, led by a nurse.

On the fourth day, the fellows were joined by select clinic partners, including nurses, pharmacists, and/or medical assistants. The session included discussions among each fellow’s clinical team regarding the current state of fall risk efforts at their clinic, an analysis of barriers, and identification of opportunities to improve workflows and screening rates. Each fellow took with them an action plan tailored to their clinic to improve fall risk management practices, starting with the fellow’s own practice.

Fall Risk Management Plan

The educational sessions introduced the fellows to the FRMP. The FRMP, adapted from the STEADI toolkit, includes a process for fall risk screening (Figure 1) and stratifying a patient’s risk based on their STEADI score in order to promote 3 priority assessments (gait evaluation with PT referral if appropriate; orthostatic blood pressure; and high-risk medication review; Figure 2). Initial actions based on these priority assessments were followed over time, with additional fall risk interventions added as clinically indicated.²⁵ The FRMP is intended to be used during routine office visits, Medicare annual wellness visits, or office visits focused on fall risk or related medical disorders (ie, fall risk visits.)

Providers and their teams were encouraged to spread out fall-related conversations with their patients over multiple visits, since many patients have multiple fall risk factors at play, in addition to other chronic medical issues, and since many interventions often require behavior changes on the part of the patient. Providers also had access to fall-related electronic health record (EHR) templates as well as a comprehensive, internal fall risk management website that included assessment tools, evidence-based resources, and patient handouts.

Assessment and Measurements

We assessed provider knowledge and comfort in their fall risk evaluation and management skills before and after the educational intervention using an 11-item multiple-choice questionnaire and a 4-item confidence questionnaire. The confidence questions used a 7-point Likert scale, with 0 indicating “no confidence” and 7 indicating ”lots of confidence.” The questions were administered via a paper survey. Qualitative comments were derived from evaluations completed at the end of the week.

The fellows’ practice of fall risk screening and management was studied from May 2018, at the completion of Mobility week, to May 2019 for the post-intervention period. A 1-year timeframe before May 2018 was used as the pre-intervention period. Eligible visit types, during which we assumed fall risk was discussed, were any office visits for patients 65+ completed by the patients’ PCPs that used fall risk as a reason for the visit or had a fall-related diagnosis code. Fall risk visits performed by other clinic providers were not counted.

Of those patients who had fall risk screenings completed and were determined to be high risk (STEADI score ≥ 4), data were analyzed to determine whether these patients had any fall-related follow-up visits to their PCP within 60 days of the STEADI screening. For these high-risk patients, data were studied to understand whether orthostatic blood pressure measurements were performed (as documented in a flowsheet) and whether a PT referral was placed. These data were compared with those from providers who practiced in clinics within the same system but who did not participate in the mini-fellowship. Data were obtained from the organization’s EHR. Additional data were measured to evaluate patterns of deprescribing of select high-risk medications, but these data are not included in this analysis.

Analysis

A paired-samples t test was used to measure changes in provider confidence levels. Data were aggregated across fellows, resulting in a mean. A chi-square test of independence was performed to examine the relationship between rates of FRMP adoption by select provider groups. Analysis included a pre- and post-intervention assessment of the fellows’ adoption of FRMP practices, as well as a comparison between the fellows’ practice patterns and those of a control group of PCPs in the organization’s other clinics who did not participate in the mini-fellowship (nontrained control group). Excluded from the control group were providers from the same clinic as the fellows; providers in clinics with a geriatric-trained provider on staff; and clinics outside of the Portland metro and Medford service areas. We used an alpha level of 0.05 for all statistical tests.

Data from 5 providers were included in the analysis of the FRMP adoption. The sixth provider changed practice settings from the clinic to the ED after completing the fellowship; her patient data were not included in the FRMP part of the analysis. EHR data included data on all visits of patients 65+, as well as data for just those 65+ patients who had been identified as being at high risk to fall based on a STEADI score of 4 or higher.

Results

Provider Questionnaire

All 6 providers responded to the pre-intervention and post-intervention tests. For the knowledge questions, fellows, as a composite, correctly answered 57% of the questions before the intervention and 79% after the intervention. Provider confidence level in delivering fall risk care was measured prior to the training (mean, 4.12 [SD, 0.62]) and at the end of the training (mean, 6.47 [SD, 0.45]), demonstrating a significant increase in confidence (t (5) = –10.46, P < 0.001).

Qualitative Comments

Providers also had the opportunity to provide comments on their experience during the Mobility week and at the end of 1 year. In general, the simulated interdisciplinary fall risk clinic was highly rated (“the highlight of the week”) as a practical strategy to embed learning principles. One fellow commented, “Putting the learning into practice helps solidify it in my brain.” Fellows also appreciated the opportunity to learn and meet with their clinic colleagues to begin work on a fall-risk focused PIP and to “have a framework for what to do for people who screen positive [for fall risk].”

FRMP Adoption

A comparison of the care the fellows provided to their patients 65+ in the 12 months pre- and post-training shows the fellows demonstrated significant changes in practice patterns. The fellows were 1.7 times more likely to screen for fall risk; 3.6 times more likely to discuss fall risk; and 5.8 times more likely to check orthostatic blood pressure than prior to the mini-fellowship (Table 1).

The control providers also demonstrated significant increases in fall risk screening and discussion of fall risk between the pre- and post-intervention periods; however, the relative risk (RR) was between 1.10 and 1.13 for this group. For the control group, checking orthostatic blood pressure did not significantly change. In the 12 months after training (Table 2), the fellows were 4.2 times more likely to discuss fall risk and almost 5 times more likely to check orthostatic blood pressure than their nontrained peers for all of their patients 65+, regardless of their risk to fall.

As shown in Table 3, for those patients determined to be at high risk of falling (STEADI score ≥ 4), fellows showed statistically significant increases in fall risk visits (RR, 3.02) and assessment of orthostatic blood pressure (RR, 10.68) before and after the mini-fellowship. The control providers did not show any changes in practice patterns between the pre- and post-period among patients at high risk to fall.

Neither the fellows nor the control group showed changes in patterns of referral to PT. In comparing the 2 groups in the 12 months after training (Table 4), for their patients at risk of falling, the fellows were 4 times more likely to complete fall risk visits and over 6 times more likely to assess orthostatic blood pressure than their nontrained peers. Subgroup analysis of the 75+ population revealed similar trends and significance, but these results are not included here.

Discussion

This study aimed to improve not only providers’ knowledge and confidence in caring for older adults at increased risk to fall, but also their clinical practice in assessing and managing fall risk. In addition to improved knowledge and confidence, we found that the fellows increased their discussion of fall risk (through fall risk visits) and their assessment of orthostatic blood pressure for all of their patients, not just for those identified at increased risk to fall. This improvement held true for the fellows themselves before and after the intervention, but also as compared to their nontrained peers. These practice improvements for all of their 65+ patients, not just those identified as being at high risk to fall, are especially important, since studies indicate that early screening and intervention can help identify people at risk and prevent future falls.¹⁵

We were surprised that there were no significant differences in PT referrals made by the trained fellows, but this finding may have been confounded by the fact that the data included all PT referrals, regardless of diagnosis, not just those referrals that were fall-related. Furthermore, our baseline PT referral rates, at 39% for the intervention group and 42% for the control group, are higher than national data when looking at rehabilitation use by older adults.²⁶

In comparison to a study evaluating the occurrence of fall risk–related clinical practice in primary care before any fall-related educational intervention, orthostatics were checked less frequently in our study (10% versus 30%) and there were fewer PT referrals (42%–44% versus 53%).²⁷ However, the Phelan study took place in patients who had actually had a fall, rather than just having a higher risk for a fall, and was based on detailed chart review. Other studies^23,24 found higher rates of fall risk interventions, but did not break out PT referrals specifically.

In terms of the educational intervention itself, most studies of geriatric education interventions have measured changes in knowledge, confidence, or self-efficacy as they relate to geriatric competence,^28-30 and do not measure practice change as an outcome outside of intent to change or self-reported practice change.^31,32 In general, practice change or longer-term health care–related outcomes have not been studied. Additionally, a range of dosages of educational interventions has been studied, from 1-hour lunchtime presentations^23,32 to half-day²⁹ or several half-day workshops,²⁸ up to 160 hours over 10 months³⁰ or 5 weekends over 6 months.³¹ The duration of our entire intervention at 160 hours over 6 months would be considered on the upper end of dosing relative to these studies, with our Mobility week intervention comprising 32 hours during 1 week. In the Warshaw study, despite 107 1-hour sessions being taught to over 60 physicians in 16 practices over 4 years, only 2 practices ultimately initiated any practice change projects.³² We believe that only curricula that embed practice change skills and opportunities, at a significant enough dose, can actually impact practice change in a sustainable manner.

Knowledge and skill acquisition among individual providers does not take place to a sufficient degree in the current health care arena, which is focused on productivity and short visit times. Consistent with other studies, we included interdisciplinary members of the primary care team for part of the mini-fellowship, although other studies used models that train across disciplines for the entirety of the learning experience.^28-30,33 Our educational model was strengthened by including other professionals to provide some of the education and model the ideal geriatric team, including PT, occupational therapy, and pharmacy, for the week on mobility.

Most studies exploring interventions through geriatric educational initiatives are conducted within academic institutions, with a primary focus on physician faculty and, by extension, their teaching of residents and others.^34,35 We believe our integrated model, which is steeped in community-based primary care practices like Lam’s,³¹ offers the greatest outreach to large community-based care systems and their patients. Training providers to work with their teams to change their own practices first gives skills and expertise that help further establish them as geriatric champions within their practices, laying the groundwork for more widespread practice change at their clinics.

Limitations

In addition to the limitations described above relating to the capture of PT referrals, other limitations included the relatively short time period for follow-up data as well as the small size of the intervention group. However, we found value in the instructional depth that the small group size allowed.

While the nontrained providers did show some improvement during the same period, we believe the relative risk was not clinically significant. We suspect that the larger health system efforts to standardize screening of patients 65+ across all clinics as a core quality metric confounded these results. The data analysis also included only fall-related patient visits that occurred with a provider who was that patient’s PCP, which could have missed visits done by other PCP colleagues, RNs, or pharmacists in the same clinic, thus undercounting the true number of fall-related visits. Furthermore, counting of fall-related interventions relied upon providers documenting consistently in the EHR, which could also lead to under-represention of fall risk clinical efforts.

The data presented, while encouraging, do not reflect clinic-wide practice change patterns and are considered only proximate outcomes rather than more long-term or cost-related outcomes, as would be captured by fall-related utilization measures like emergency room visits and hospitalizations. We expect to evaluate the broader impact and these value-based outcomes in the future. All providers and teams were from the same health care system, which may not allow our results to transfer to other organizations or regions of clinical practice.

Summary

This study demonstrates that an intensive mini-fellowship model of geriatrics training improved both knowledge and confidence in the realm of fall risk assessment and intervention among PCPs who had not been formally trained in geriatrics. More importantly, the training improved the fall-related care of their patients at increased risk to fall, but also of all of their older patients, with improvements in care measured up to a year after the mini-fellowship. Although this article only describes the work done as part of the Mobility aim of the 4M AFHS model, we believe the entire mini-fellowship curriculum offers the opportunity to “geriatricize” clinicians and their teams in learning geriatric principles and skills that they can translate into their practice in a sustainable way, as Tinetti encourages.⁸ Future study to evaluate other process outcomes more precisely, such as PT, as well as cost- and value-based outcomes, and the influence of trained providers on their clinic partners, will further establish the value proposition of targeted, disseminated, intensive geriatrics training of primary care clinicians as a strategy of age-friendly health systems as they work to improve the care of their older adults.

Acknowledgment: We are grateful for the dedication and hard work of the 2018 Geriatric Mini-Fellowship fellows at Providence Health & Services-Oregon who made this article possible. Thanks to Drs. Stephanie Cha, Emily Puukka-Clark, Laurie Dutkiewicz, Cara Ellis, Deb Frost, Jordan Roth, and Subhechchha Shah for promoting the AFHS work within their Providence Medical Group clinics and to PMG leadership and the fellows’ clinical teams for supporting the fellows, the AFHS work, and their older patients.

Corresponding author: Colleen M. Casey, PhD, ANP-BC, Providence Health & Services, Senior Health Program, 4400 NE Halsey, 5th Floor, Portland, OR 97213; [email protected].

Financial disclosures: None.

From the Senior Health Program, Providence Health & Services, Oregon, Portland, OR.

Abstract

Background: Approximately 51 million adults in the United States are 65 years of age or older, yet few geriatric-trained primary care providers (PCP) serve this population. The Age-Friendly Health System framework, consisting of evidence-based 4M care (Mobility, Medication, Mentation, and what Matters), encourages all PCPs to assess mobility in older adults.

Objective: To improve PCP knowledge, confidence, and clinical practice in assessing and managing fall risk.

Methods: A 1-week educational session focusing on mobility (part of a 4-week Geriatric Mini-Fellowship) for 6 selected PCPs from a large health care system was conducted to increase knowledge and ability to address fall risk in older adults. The week included learning and practicing a Fall Risk Management Plan (FRMP) algorithm, including planning for their own practice changes. Pre- and post-test surveys assessed changes in knowledge and confidence. Patient data were compared 12 months before and after training to evaluate PCP adoption of FRMP components.

Results: The training increased provider knowledge and confidence. The trained PCPs were 1.7 times more likely to screen for fall risk; 3.6 times more likely to discuss fall risk; and 5.8 times more likely to assess orthostatic blood pressure in their 65+ patients after the mini-fellowship. In high-risk patients, they were 4.1 times more likely to discuss fall risk and 6.3 times more likely to assess orthostatic blood pressure than their nontrained peers. Changes in physical therapy referral rates were not observed.

Conclusions: In-depth, skills-based geriatric educational sessions improved PCPs’ knowledge and confidence and also improved their fall risk management practices for their older patients.

Keywords: geriatrics; guidelines; Age-Friendly Health System; 4M; workforce training; practice change; fellowship.

The US population is aging rapidly. People aged 85 years and older are the largest-growing segment of the US population, and this segment is expected to increase by 123% by 2040.¹ Caregiving needs increase with age as older adults develop more chronic conditions, such as hypertension, heart disease, arthritis, and dementia. However, even with increasing morbidity and dependence, a majority of older adults still live in the community rather than in institutional settings.² These older adults seek medical care more frequently than younger people, with about 22% of patients 75 years and older having 10 or more health care visits in the previous 12 months. By 2040, nearly a quarter of the US population is expected to be 65 or older, with many of these older adults seeking regular primary care from providers who do not have formal training in the care of a population with multiple complex, chronic health conditions and increased caregiving needs.¹

Despite this growing demand for health care professionals trained in the care of older adults, access to these types of clinicians is limited. In 2018, there were roughly 7000 certified geriatricians, with only 3600 of them practicing full-time.^3,4 Similarly, of 290,000 certified nurse practitioners (NPs), about 9% of them have geriatric certification.⁵ Geriatricians, medical doctors trained in the care of older adults, and geriatric-trained NPs are part of a cadre of a geriatric-trained workforce that provides unique expertise in caring for older adults with chronic and advanced illness. They know how to manage multiple, complex geriatric syndromes like falls, dementia, and polypharmacy; understand and maximize team-based care; and focus on caring for an older person with a goal-centered versus a disease-centered approach.⁶

Broadly, geriatric care includes a spectrum of adults, from those who are aging healthfully to those who are the frailest. Research has suggested that approximately 30% of older adults need care by a geriatric-trained clinician, with the oldest and frailest patients needing more clinician time for assessment and treatment, care coordination, and coaching of caregivers.⁷ With this assumption in mind, it is projected that by 2025, there will be a national shortage of 26,980 geriatricians, with the western United States disproportionately affected by this shortage.⁴Rather than lamenting this shortage, Tinetti recommends a new path forward: “Our mission should not be to train enough geriatricians to provide direct care, but rather to ensure that every clinician caring for older adults is competent in geriatric principles and practices.”⁸ Sometimes called ”geriatricizing,” the idea is to use existing geriatric providers as a small elite training force to infuse geriatric principles and skills across their colleagues in primary care and other disciplines.^8,9 Efforts of the American Geriatrics Society (AGS), with support from the John A. Hartford Foundation (JAHF), have been successful in developing geriatric training across multiple specialties, including surgery, orthopedics, and emergency medicine (www.americangeriatrics.org/programs/geriatrics-specialists-initiative).

The Age-Friendly Health System and 4M Model

To help augment this idea of equipping health care systems and their clinicians with more readily available geriatric knowledge, skills, and tools, the JAHF, along with the Institute for Healthcare Improvement (IHI), created the Age-Friendly Health System (AFHS) paradigm in 2015.¹⁰ Using the 4M model, the AFHS initiative established a set of evidence-based geriatric priorities and interventions meant to improve the care of older adults, reduce harm and duplication, and provide a framework for engaging leadership, clinical teams, and operational systems across inpatient and ambulatory settings.¹¹ Mobility, including fall risk screening and intervention, is 1 of the 4M foundational elements of the Age-Friendly model. In addition to Mobility, the 4M model also includes 3 other key geriatric domains: Mentation (dementia, depression, and delirium), Medication (high-risk medications, polypharmacy, and deprescribing), and What Matters (goals of care conversations and understanding quality of life for older patients).¹¹ The 4M initiative encourages adoption of a geriatric lens that looks across chronic conditions and accounts for the interplay among geriatric syndromes, such as falls, cognitive impairment, and frailty, in order to provide care better tailored to what the patient needs and desires.¹² IHI and JAHF have targeted the adoption of the 4M model by 20% of US health care systems by 2020.¹¹

Mini-Fellowship and Mobility Week

To bolster geriatric skills among community-based primary care providers (PCPs), we initiated a Geriatric Mini-Fellowship, a 4-week condensed curriculum taught over 6 months. Each week focuses on 1 of the age-friendly 4Ms, with the goal of increasing the knowledge, self-efficacy, skills, and competencies of the participating PCPs (called “fellow” hereafter) and at the same time, equipping each to become a champion of geriatric practice. This article focuses on the Mobility week, the second week of the mini-fellowship, and the effect of the week on the fellows’ practice changes.

To construct the Mobility week’s curriculum with a focus on the ambulatory setting, we relied upon national evidence-based work in fall risk management. The Centers for Disease Control and Prevention (CDC) has made fall risk screening and management in primary care a high priority. Using the clinical practice guidelines for managing fall risk developed by the American and British Geriatrics Societies (AGS/BGS), the CDC developed the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) toolkit.¹³ Foundational to the toolkit is the validated 12-item Stay Independent falls screening questionnaire (STEADI questionnaire).¹⁴ Patients who score 4 or higher (out of a total score of 14) on the questionnaire are considered at increased risk of falling. The CDC has developed a clinical algorithm that guides clinical teams through screening and assessment to help identify appropriate interventions to target specific risk factors. Research has clearly established that a multifactorial approach to fall risk intervention can be successful in reducing fall risk by as much as 25%.^15-17

The significant morbidity and mortality caused by falls make training nongeriatrician clinicians on how to better address fall risk imperative. More than 25% of older adults fall each year.¹⁸ These falls contribute to rising rates of fall-related deaths,¹⁹ emergency department (ED) visits,²⁰ and hospital readmissions.²¹ Initiatives like the AFHS focus on mobility and the CDC’s development of supporting clinical materials²² aim to improve primary care adoption of fall risk screening and intervention practices.^23,24 The epidemic of falls must compel all PCPs, not just those practicing geriatrics, to make discussing and addressing fall risk and falls a priority.

Methods

Setting

This project took place as part of a regional primary care effort in Oregon. Providence Health & Services-Oregon is part of a multi-state integrated health care system in the western United States whose PCPs serve more than 80,000 patients aged 65 years and older per year; these patients comprise 38% of the system’s office visits each year. Regionally, there are 47 family and internal medicine clinics employing roughly 290 providers (physicians, NPs, and physician assistants). The organization has only 4 PCPs trained in geriatrics and does not offer any geriatric clinical consultation services. Six PCPs from different clinics, representing both rural and urban settings, are chosen to participate in the geriatric mini-fellowship each year.

This project was conducted as a quality improvement initiative within the organization and did not constitute human subjects research. It was not conducted under the oversight of the Institutional Review Board.

Intervention

The mini-fellowship was taught in 4 1-week blocks between April and October 2018, with a curriculum designed to be interactive and practical. The faculty was intentionally interdisciplinary to teach and model team-based practice. Each week participants were excused from their clinical practice. Approximately 160 hours of continuing medical education credits were awarded for the full mini-fellowship. As part of each weekly session, a performance improvement project (PIP) focused on that week’s topic (1 of the 4Ms) was developed by the fellow and their team members to incorporate the mini-fellowship learnings into their clinic workflows. Fellows also had 2 hours per week of dedicated administration time for a year, outside the fellowship, to work on their PIP and 4M practice changes within their clinic.

Provider Education

The week for mobility training comprised 4 daylong sessions. The first 2 days were spent learning about the epidemiology of falls; risk factors for falling; how to conduct a thorough history and assessment of fall risk; and how to create a prioritized Fall Risk Management Plan (FRMP) to decrease a patient’s individual fall risk through tailored interventions. The FRMP was adapted from the CDC STEADI toolkit.¹³ Core faculty were 2 geriatric-trained providers (NP and physician) and a physical therapist (PT) specializing in fall prevention.

On the third day, fellows took part in a simulated fall risk clinic, in which older adults volunteered to be patient partners, providing an opportunity to apply learnings from days 1 and 2. The clinic included the fellow observing a PT complete a mobility assessment and a pharmacist conduct a high-risk medication review. The fellow synthesized the findings of the mobility assessment and medication review, as well as their own history and assessment, to create a summary of fall risk recommendations to discuss with their volunteer patient partner. The fellows were observed and evaluated in their skills by their patient partner, course faculty, and another fellow. The patient partners, and their assigned fellow, also participated in a 45-minute fall risk presentation, led by a nurse.

On the fourth day, the fellows were joined by select clinic partners, including nurses, pharmacists, and/or medical assistants. The session included discussions among each fellow’s clinical team regarding the current state of fall risk efforts at their clinic, an analysis of barriers, and identification of opportunities to improve workflows and screening rates. Each fellow took with them an action plan tailored to their clinic to improve fall risk management practices, starting with the fellow’s own practice.

Fall Risk Management Plan

The educational sessions introduced the fellows to the FRMP. The FRMP, adapted from the STEADI toolkit, includes a process for fall risk screening (Figure 1) and stratifying a patient’s risk based on their STEADI score in order to promote 3 priority assessments (gait evaluation with PT referral if appropriate; orthostatic blood pressure; and high-risk medication review; Figure 2). Initial actions based on these priority assessments were followed over time, with additional fall risk interventions added as clinically indicated.²⁵ The FRMP is intended to be used during routine office visits, Medicare annual wellness visits, or office visits focused on fall risk or related medical disorders (ie, fall risk visits.)

Providers and their teams were encouraged to spread out fall-related conversations with their patients over multiple visits, since many patients have multiple fall risk factors at play, in addition to other chronic medical issues, and since many interventions often require behavior changes on the part of the patient. Providers also had access to fall-related electronic health record (EHR) templates as well as a comprehensive, internal fall risk management website that included assessment tools, evidence-based resources, and patient handouts.

Assessment and Measurements

We assessed provider knowledge and comfort in their fall risk evaluation and management skills before and after the educational intervention using an 11-item multiple-choice questionnaire and a 4-item confidence questionnaire. The confidence questions used a 7-point Likert scale, with 0 indicating “no confidence” and 7 indicating ”lots of confidence.” The questions were administered via a paper survey. Qualitative comments were derived from evaluations completed at the end of the week.

The fellows’ practice of fall risk screening and management was studied from May 2018, at the completion of Mobility week, to May 2019 for the post-intervention period. A 1-year timeframe before May 2018 was used as the pre-intervention period. Eligible visit types, during which we assumed fall risk was discussed, were any office visits for patients 65+ completed by the patients’ PCPs that used fall risk as a reason for the visit or had a fall-related diagnosis code. Fall risk visits performed by other clinic providers were not counted.

Of those patients who had fall risk screenings completed and were determined to be high risk (STEADI score ≥ 4), data were analyzed to determine whether these patients had any fall-related follow-up visits to their PCP within 60 days of the STEADI screening. For these high-risk patients, data were studied to understand whether orthostatic blood pressure measurements were performed (as documented in a flowsheet) and whether a PT referral was placed. These data were compared with those from providers who practiced in clinics within the same system but who did not participate in the mini-fellowship. Data were obtained from the organization’s EHR. Additional data were measured to evaluate patterns of deprescribing of select high-risk medications, but these data are not included in this analysis.

Analysis

A paired-samples t test was used to measure changes in provider confidence levels. Data were aggregated across fellows, resulting in a mean. A chi-square test of independence was performed to examine the relationship between rates of FRMP adoption by select provider groups. Analysis included a pre- and post-intervention assessment of the fellows’ adoption of FRMP practices, as well as a comparison between the fellows’ practice patterns and those of a control group of PCPs in the organization’s other clinics who did not participate in the mini-fellowship (nontrained control group). Excluded from the control group were providers from the same clinic as the fellows; providers in clinics with a geriatric-trained provider on staff; and clinics outside of the Portland metro and Medford service areas. We used an alpha level of 0.05 for all statistical tests.

Data from 5 providers were included in the analysis of the FRMP adoption. The sixth provider changed practice settings from the clinic to the ED after completing the fellowship; her patient data were not included in the FRMP part of the analysis. EHR data included data on all visits of patients 65+, as well as data for just those 65+ patients who had been identified as being at high risk to fall based on a STEADI score of 4 or higher.

Results

Provider Questionnaire

All 6 providers responded to the pre-intervention and post-intervention tests. For the knowledge questions, fellows, as a composite, correctly answered 57% of the questions before the intervention and 79% after the intervention. Provider confidence level in delivering fall risk care was measured prior to the training (mean, 4.12 [SD, 0.62]) and at the end of the training (mean, 6.47 [SD, 0.45]), demonstrating a significant increase in confidence (t (5) = –10.46, P < 0.001).

Qualitative Comments

Providers also had the opportunity to provide comments on their experience during the Mobility week and at the end of 1 year. In general, the simulated interdisciplinary fall risk clinic was highly rated (“the highlight of the week”) as a practical strategy to embed learning principles. One fellow commented, “Putting the learning into practice helps solidify it in my brain.” Fellows also appreciated the opportunity to learn and meet with their clinic colleagues to begin work on a fall-risk focused PIP and to “have a framework for what to do for people who screen positive [for fall risk].”

FRMP Adoption

A comparison of the care the fellows provided to their patients 65+ in the 12 months pre- and post-training shows the fellows demonstrated significant changes in practice patterns. The fellows were 1.7 times more likely to screen for fall risk; 3.6 times more likely to discuss fall risk; and 5.8 times more likely to check orthostatic blood pressure than prior to the mini-fellowship (Table 1).

The control providers also demonstrated significant increases in fall risk screening and discussion of fall risk between the pre- and post-intervention periods; however, the relative risk (RR) was between 1.10 and 1.13 for this group. For the control group, checking orthostatic blood pressure did not significantly change. In the 12 months after training (Table 2), the fellows were 4.2 times more likely to discuss fall risk and almost 5 times more likely to check orthostatic blood pressure than their nontrained peers for all of their patients 65+, regardless of their risk to fall.

As shown in Table 3, for those patients determined to be at high risk of falling (STEADI score ≥ 4), fellows showed statistically significant increases in fall risk visits (RR, 3.02) and assessment of orthostatic blood pressure (RR, 10.68) before and after the mini-fellowship. The control providers did not show any changes in practice patterns between the pre- and post-period among patients at high risk to fall.

Neither the fellows nor the control group showed changes in patterns of referral to PT. In comparing the 2 groups in the 12 months after training (Table 4), for their patients at risk of falling, the fellows were 4 times more likely to complete fall risk visits and over 6 times more likely to assess orthostatic blood pressure than their nontrained peers. Subgroup analysis of the 75+ population revealed similar trends and significance, but these results are not included here.

Discussion

This study aimed to improve not only providers’ knowledge and confidence in caring for older adults at increased risk to fall, but also their clinical practice in assessing and managing fall risk. In addition to improved knowledge and confidence, we found that the fellows increased their discussion of fall risk (through fall risk visits) and their assessment of orthostatic blood pressure for all of their patients, not just for those identified at increased risk to fall. This improvement held true for the fellows themselves before and after the intervention, but also as compared to their nontrained peers. These practice improvements for all of their 65+ patients, not just those identified as being at high risk to fall, are especially important, since studies indicate that early screening and intervention can help identify people at risk and prevent future falls.¹⁵

We were surprised that there were no significant differences in PT referrals made by the trained fellows, but this finding may have been confounded by the fact that the data included all PT referrals, regardless of diagnosis, not just those referrals that were fall-related. Furthermore, our baseline PT referral rates, at 39% for the intervention group and 42% for the control group, are higher than national data when looking at rehabilitation use by older adults.²⁶

In comparison to a study evaluating the occurrence of fall risk–related clinical practice in primary care before any fall-related educational intervention, orthostatics were checked less frequently in our study (10% versus 30%) and there were fewer PT referrals (42%–44% versus 53%).²⁷ However, the Phelan study took place in patients who had actually had a fall, rather than just having a higher risk for a fall, and was based on detailed chart review. Other studies^23,24 found higher rates of fall risk interventions, but did not break out PT referrals specifically.

In terms of the educational intervention itself, most studies of geriatric education interventions have measured changes in knowledge, confidence, or self-efficacy as they relate to geriatric competence,^28-30 and do not measure practice change as an outcome outside of intent to change or self-reported practice change.^31,32 In general, practice change or longer-term health care–related outcomes have not been studied. Additionally, a range of dosages of educational interventions has been studied, from 1-hour lunchtime presentations^23,32 to half-day²⁹ or several half-day workshops,²⁸ up to 160 hours over 10 months³⁰ or 5 weekends over 6 months.³¹ The duration of our entire intervention at 160 hours over 6 months would be considered on the upper end of dosing relative to these studies, with our Mobility week intervention comprising 32 hours during 1 week. In the Warshaw study, despite 107 1-hour sessions being taught to over 60 physicians in 16 practices over 4 years, only 2 practices ultimately initiated any practice change projects.³² We believe that only curricula that embed practice change skills and opportunities, at a significant enough dose, can actually impact practice change in a sustainable manner.

Knowledge and skill acquisition among individual providers does not take place to a sufficient degree in the current health care arena, which is focused on productivity and short visit times. Consistent with other studies, we included interdisciplinary members of the primary care team for part of the mini-fellowship, although other studies used models that train across disciplines for the entirety of the learning experience.^28-30,33 Our educational model was strengthened by including other professionals to provide some of the education and model the ideal geriatric team, including PT, occupational therapy, and pharmacy, for the week on mobility.

Most studies exploring interventions through geriatric educational initiatives are conducted within academic institutions, with a primary focus on physician faculty and, by extension, their teaching of residents and others.^34,35 We believe our integrated model, which is steeped in community-based primary care practices like Lam’s,³¹ offers the greatest outreach to large community-based care systems and their patients. Training providers to work with their teams to change their own practices first gives skills and expertise that help further establish them as geriatric champions within their practices, laying the groundwork for more widespread practice change at their clinics.

Limitations

In addition to the limitations described above relating to the capture of PT referrals, other limitations included the relatively short time period for follow-up data as well as the small size of the intervention group. However, we found value in the instructional depth that the small group size allowed.

While the nontrained providers did show some improvement during the same period, we believe the relative risk was not clinically significant. We suspect that the larger health system efforts to standardize screening of patients 65+ across all clinics as a core quality metric confounded these results. The data analysis also included only fall-related patient visits that occurred with a provider who was that patient’s PCP, which could have missed visits done by other PCP colleagues, RNs, or pharmacists in the same clinic, thus undercounting the true number of fall-related visits. Furthermore, counting of fall-related interventions relied upon providers documenting consistently in the EHR, which could also lead to under-represention of fall risk clinical efforts.

The data presented, while encouraging, do not reflect clinic-wide practice change patterns and are considered only proximate outcomes rather than more long-term or cost-related outcomes, as would be captured by fall-related utilization measures like emergency room visits and hospitalizations. We expect to evaluate the broader impact and these value-based outcomes in the future. All providers and teams were from the same health care system, which may not allow our results to transfer to other organizations or regions of clinical practice.

Summary

This study demonstrates that an intensive mini-fellowship model of geriatrics training improved both knowledge and confidence in the realm of fall risk assessment and intervention among PCPs who had not been formally trained in geriatrics. More importantly, the training improved the fall-related care of their patients at increased risk to fall, but also of all of their older patients, with improvements in care measured up to a year after the mini-fellowship. Although this article only describes the work done as part of the Mobility aim of the 4M AFHS model, we believe the entire mini-fellowship curriculum offers the opportunity to “geriatricize” clinicians and their teams in learning geriatric principles and skills that they can translate into their practice in a sustainable way, as Tinetti encourages.⁸ Future study to evaluate other process outcomes more precisely, such as PT, as well as cost- and value-based outcomes, and the influence of trained providers on their clinic partners, will further establish the value proposition of targeted, disseminated, intensive geriatrics training of primary care clinicians as a strategy of age-friendly health systems as they work to improve the care of their older adults.

Acknowledgment: We are grateful for the dedication and hard work of the 2018 Geriatric Mini-Fellowship fellows at Providence Health & Services-Oregon who made this article possible. Thanks to Drs. Stephanie Cha, Emily Puukka-Clark, Laurie Dutkiewicz, Cara Ellis, Deb Frost, Jordan Roth, and Subhechchha Shah for promoting the AFHS work within their Providence Medical Group clinics and to PMG leadership and the fellows’ clinical teams for supporting the fellows, the AFHS work, and their older patients.

Corresponding author: Colleen M. Casey, PhD, ANP-BC, Providence Health & Services, Senior Health Program, 4400 NE Halsey, 5th Floor, Portland, OR 97213; [email protected].

Financial disclosures: None.

“Defund the police”: It’s a slogan, or perhaps a battle cry, that has emerged from the Black Lives Matter movement as a response to race-related police brutality and concerns that people of color are profiled, targeted, arrested, charged, manhandled, and killed by law enforcement in a disproportionate and unjust manner. It crosses into our realm as psychiatrists as mental health emergency calls are handled by the police and not by mental health professionals. The result is sometimes tragic: As many as half of police shootings involve people with psychiatric disorders, and the hope is that many of the police shootings could be avoided if crises were handed by mental health clinicians instead of, or in cooperation with, the police.

At best, police officers receive a week of specialized, crisis intervention training about how to approach those with psychiatric disorders; most officers receive no training. This leaves psychiatry as the only field where medical crises are routinely handled by the police – it is demeaning and embarrassing for some of our patients and dangerous for others. The reality remains, however, that there are times when psychiatric disorders result in violent behavior, and patients being taken for involuntary treatment often resist transport, so either way there is risk, both to the patient and to anyone who responds to a call for assistance.

Early this month, the office of New York City Mayor Bill de Blasio announced that a major change would be made in how mental health calls to 911 are handled in two “high-need” areas. The mayor’s website states:

“Beginning in February 2021, new Mental Health Teams will use their physical and mental health expertise, and experience in crisis response to de-escalate emergency situations, will help reduce the number of times police will need to respond to 911 mental health calls in these precincts. These teams will have the expertise to respond to a range of behavioral health problems, such as suicide attempts, substance misuse, and serious mental illness, as well as physical health problems, which can be exacerbated by or mask mental health problems. NYC Health + Hospitals will train and provide ongoing technical assistance and support. In selecting team members for this program, FDNY will prioritize professionals with significant experience with mental health crises.”

The press release goes on to say that, in situations where there is a weapon or reason to believe there is a risk of violence, the police will be dispatched along with the new mental health team.

“This is the first time in our history that health professionals will be the default responders to mental health emergencies,” New York City First Lady Chirlane McCray said as she announced the new program. “Treating mental health crises as mental health challenges and not public safety ones is the modern and more appropriate approach.”

New York City is not the first city to employ this model. In the United States, the CAHOOTS (Crisis Assistance Helping Out on the Streets) program in Eugene, Ore., has been run by the White Bird Clinic since 1989 as part of a community policing initiative. Last year, the team responded to 24,000 calls and police backup was required on only 150 of those responses. The CAHOOTS website states:

“The CAHOOTS model has been in the spotlight recently as our nation struggles to reimagine public safety. The program mobilizes two-person teams consisting of a medic (a nurse, paramedic, or EMT) and a crisis worker who has substantial training and experience in the mental health field. The CAHOOTS teams deal with a wide range of mental health-related crises, including conflict resolution, welfare checks, substance abuse, suicide threats, and more, relying on trauma-informed de-escalation and harm reduction techniques. CAHOOTS staff are not law enforcement officers and do not carry weapons; their training and experience are the tools they use to ensure a non-violent resolution of crisis situations. They also handle non-emergent medical issues, avoiding costly ambulance transport and emergency room treatment.”

Other cities in the United States are also looking at implementing programs where mental health teams, and not the police, respond to emergency calls. Last year, Oakland, Calif.’s city council invested $40,000 in research to assess how they could best implement a program like the one in Eugene. They hope to begin the Mobile Assistance Community Responders of Oakland (MACROS) next year. Sigal Samuel writes in a Vox article, “The goal is to launch the pilot next year with funding from the city budget, and although supporters are not yet sure what its size and duration will be, they’re hopeful it’ll make a big difference to Oakland’s overpoliced community of people without homes. They were among those who first called for a non-policing approach.”

The model is not unique to the United States. In 2005, Stockholm started a program with a psychiatric ambulance – equipped with comfortable seating rather than a stretcher – to respond to mental health emergencies. The ambulance responds to 130 calls a month. It is staffed with a driver and two psychiatric nurses, and for half of the calls, the police also come. While the Swedish program was not about removing resources from the police, it has relieved the police of the responsibility for many psychiatric emergencies.

The New York City program will be modeled after the CAHOOTS initiative in Eugene. It differs from the mobile crisis response services in many other cities because CAHOOTS is hooked directly into the 911 emergency services system. Its website notes that the program has saved money:

“The cost savings are considerable. The CAHOOTS program budget is about $2.1 million annually, while the combined annual budgets for the Eugene and Springfield police departments are $90 million. In 2017, the CAHOOTS teams answered 17% of the Eugene Police Department’s overall call volume. The program saves the city of Eugene an estimated $8.5 million in public safety spending annually.”

Some worry there is an unpredictable aspect to calls for psychiatric emergencies, and the potential for mental health professions to be injured or killed. Annette Hanson, MD, a forensic psychiatrist at University of Maryland, Baltimore, voiced her concerns, “While multidisciplinary teams are useful, there have been rare cases of violence against responding mental health providers. People with serious mental illness are rarely violent but their dangerousness is unpredictable and cannot be predicted by case screening.”

Daniel Felts is a mental health crisis counselor who has worked at CAHOOTS for the past 4* years. He has responded to about 8,000 calls, and called for police backup only three times to request an immediate "Code 3 cover" when someone's safety has been in danger. Mr. Felts calls the police about once a month for concerns that do not require an immediate response for safety.* “Over the last 4 years, I am only aware of three instances when a team member’s safety was compromised because of a client’s violent behavior. No employee has been seriously physically harmed. In 30 years, with hundreds of thousands (millions?) of calls responded to, no CAHOOTS worker has ever been killed, shot, or stabbed in the line of duty,” Mr. Felts noted.

Emergency calls are screened. “It is not uncommon for CAHOOTS to be dispatched to ‘stage’ for calls involving active disputes or acutely suicidal individuals where means are present. “Staging” entails us parking roughly a mile away while police make first contact and advise whether it is safe for CAHOOTS to engage.”

Mr. Felts went on to discuss the program’s relationship with the community. “I believe that one of the biggest things that keeps us safe is the community’s knowledge and understanding of our service and how we operate. Having operated in Eugene for 30 years, our service is well understood to be one that does not kill, harm, or violate personal boundaries or liberties.”

Would a program like the ones in Stockholm or in Eugene work in other places? Eugene is a city with a population of 172,000 with a low crime rate. Whether a program implemented in one city can be mimicked in another very different city is not clear.

Paul Appelbaum, MD, a forensic psychiatrist at Columbia University, New York, is optimistic about New York City’s forthcoming program.

“The proposed pilot project in NYC is a real step forward. Work that we’ve done looking at fatal encounters involving the police found that roughly 25% of all deaths at the hands of the police are of people with mental illness. In many of those cases, police were initially called to bring people who were clearly troubled for psychiatric evaluation, but as the situation escalated, the police turned to their weapons to control it, which led to a fatal outcome. Taking police out of the picture whenever possible in favor of trained mental health personnel is clearly a better approach. It will be important for the city to collect good outcome data to enable independent evaluation of the pilot project – not something that political entities are inclined toward, but a critical element in assessing the effectiveness of this approach.”

There are questions that remain about the new program. Mayor de Blasio’s office has not released information about which areas of the city are being chosen for the new program, how much the program will cost, or what the funding source will be. If it can be implemented safely and effectively, it has the potential to provide more sensitive care to patients in crisis, and to save lives.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

*Correction, 11/27/2020: An earlier version of this article misstated the number of years Daniel Felts has worked at CAHOOTS.

“Defund the police”: It’s a slogan, or perhaps a battle cry, that has emerged from the Black Lives Matter movement as a response to race-related police brutality and concerns that people of color are profiled, targeted, arrested, charged, manhandled, and killed by law enforcement in a disproportionate and unjust manner. It crosses into our realm as psychiatrists as mental health emergency calls are handled by the police and not by mental health professionals. The result is sometimes tragic: As many as half of police shootings involve people with psychiatric disorders, and the hope is that many of the police shootings could be avoided if crises were handed by mental health clinicians instead of, or in cooperation with, the police.

At best, police officers receive a week of specialized, crisis intervention training about how to approach those with psychiatric disorders; most officers receive no training. This leaves psychiatry as the only field where medical crises are routinely handled by the police – it is demeaning and embarrassing for some of our patients and dangerous for others. The reality remains, however, that there are times when psychiatric disorders result in violent behavior, and patients being taken for involuntary treatment often resist transport, so either way there is risk, both to the patient and to anyone who responds to a call for assistance.

Early this month, the office of New York City Mayor Bill de Blasio announced that a major change would be made in how mental health calls to 911 are handled in two “high-need” areas. The mayor’s website states:

“Beginning in February 2021, new Mental Health Teams will use their physical and mental health expertise, and experience in crisis response to de-escalate emergency situations, will help reduce the number of times police will need to respond to 911 mental health calls in these precincts. These teams will have the expertise to respond to a range of behavioral health problems, such as suicide attempts, substance misuse, and serious mental illness, as well as physical health problems, which can be exacerbated by or mask mental health problems. NYC Health + Hospitals will train and provide ongoing technical assistance and support. In selecting team members for this program, FDNY will prioritize professionals with significant experience with mental health crises.”

The press release goes on to say that, in situations where there is a weapon or reason to believe there is a risk of violence, the police will be dispatched along with the new mental health team.

“This is the first time in our history that health professionals will be the default responders to mental health emergencies,” New York City First Lady Chirlane McCray said as she announced the new program. “Treating mental health crises as mental health challenges and not public safety ones is the modern and more appropriate approach.”

New York City is not the first city to employ this model. In the United States, the CAHOOTS (Crisis Assistance Helping Out on the Streets) program in Eugene, Ore., has been run by the White Bird Clinic since 1989 as part of a community policing initiative. Last year, the team responded to 24,000 calls and police backup was required on only 150 of those responses. The CAHOOTS website states:

“The CAHOOTS model has been in the spotlight recently as our nation struggles to reimagine public safety. The program mobilizes two-person teams consisting of a medic (a nurse, paramedic, or EMT) and a crisis worker who has substantial training and experience in the mental health field. The CAHOOTS teams deal with a wide range of mental health-related crises, including conflict resolution, welfare checks, substance abuse, suicide threats, and more, relying on trauma-informed de-escalation and harm reduction techniques. CAHOOTS staff are not law enforcement officers and do not carry weapons; their training and experience are the tools they use to ensure a non-violent resolution of crisis situations. They also handle non-emergent medical issues, avoiding costly ambulance transport and emergency room treatment.”

Other cities in the United States are also looking at implementing programs where mental health teams, and not the police, respond to emergency calls. Last year, Oakland, Calif.’s city council invested $40,000 in research to assess how they could best implement a program like the one in Eugene. They hope to begin the Mobile Assistance Community Responders of Oakland (MACROS) next year. Sigal Samuel writes in a Vox article, “The goal is to launch the pilot next year with funding from the city budget, and although supporters are not yet sure what its size and duration will be, they’re hopeful it’ll make a big difference to Oakland’s overpoliced community of people without homes. They were among those who first called for a non-policing approach.”

The model is not unique to the United States. In 2005, Stockholm started a program with a psychiatric ambulance – equipped with comfortable seating rather than a stretcher – to respond to mental health emergencies. The ambulance responds to 130 calls a month. It is staffed with a driver and two psychiatric nurses, and for half of the calls, the police also come. While the Swedish program was not about removing resources from the police, it has relieved the police of the responsibility for many psychiatric emergencies.

The New York City program will be modeled after the CAHOOTS initiative in Eugene. It differs from the mobile crisis response services in many other cities because CAHOOTS is hooked directly into the 911 emergency services system. Its website notes that the program has saved money:

“The cost savings are considerable. The CAHOOTS program budget is about $2.1 million annually, while the combined annual budgets for the Eugene and Springfield police departments are $90 million. In 2017, the CAHOOTS teams answered 17% of the Eugene Police Department’s overall call volume. The program saves the city of Eugene an estimated $8.5 million in public safety spending annually.”

Some worry there is an unpredictable aspect to calls for psychiatric emergencies, and the potential for mental health professions to be injured or killed. Annette Hanson, MD, a forensic psychiatrist at University of Maryland, Baltimore, voiced her concerns, “While multidisciplinary teams are useful, there have been rare cases of violence against responding mental health providers. People with serious mental illness are rarely violent but their dangerousness is unpredictable and cannot be predicted by case screening.”

Daniel Felts is a mental health crisis counselor who has worked at CAHOOTS for the past 4* years. He has responded to about 8,000 calls, and called for police backup only three times to request an immediate "Code 3 cover" when someone's safety has been in danger. Mr. Felts calls the police about once a month for concerns that do not require an immediate response for safety.* “Over the last 4 years, I am only aware of three instances when a team member’s safety was compromised because of a client’s violent behavior. No employee has been seriously physically harmed. In 30 years, with hundreds of thousands (millions?) of calls responded to, no CAHOOTS worker has ever been killed, shot, or stabbed in the line of duty,” Mr. Felts noted.

Emergency calls are screened. “It is not uncommon for CAHOOTS to be dispatched to ‘stage’ for calls involving active disputes or acutely suicidal individuals where means are present. “Staging” entails us parking roughly a mile away while police make first contact and advise whether it is safe for CAHOOTS to engage.”

Mr. Felts went on to discuss the program’s relationship with the community. “I believe that one of the biggest things that keeps us safe is the community’s knowledge and understanding of our service and how we operate. Having operated in Eugene for 30 years, our service is well understood to be one that does not kill, harm, or violate personal boundaries or liberties.”

Would a program like the ones in Stockholm or in Eugene work in other places? Eugene is a city with a population of 172,000 with a low crime rate. Whether a program implemented in one city can be mimicked in another very different city is not clear.

Paul Appelbaum, MD, a forensic psychiatrist at Columbia University, New York, is optimistic about New York City’s forthcoming program.

“The proposed pilot project in NYC is a real step forward. Work that we’ve done looking at fatal encounters involving the police found that roughly 25% of all deaths at the hands of the police are of people with mental illness. In many of those cases, police were initially called to bring people who were clearly troubled for psychiatric evaluation, but as the situation escalated, the police turned to their weapons to control it, which led to a fatal outcome. Taking police out of the picture whenever possible in favor of trained mental health personnel is clearly a better approach. It will be important for the city to collect good outcome data to enable independent evaluation of the pilot project – not something that political entities are inclined toward, but a critical element in assessing the effectiveness of this approach.”

There are questions that remain about the new program. Mayor de Blasio’s office has not released information about which areas of the city are being chosen for the new program, how much the program will cost, or what the funding source will be. If it can be implemented safely and effectively, it has the potential to provide more sensitive care to patients in crisis, and to save lives.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

*Correction, 11/27/2020: An earlier version of this article misstated the number of years Daniel Felts has worked at CAHOOTS.

“Defund the police”: It’s a slogan, or perhaps a battle cry, that has emerged from the Black Lives Matter movement as a response to race-related police brutality and concerns that people of color are profiled, targeted, arrested, charged, manhandled, and killed by law enforcement in a disproportionate and unjust manner. It crosses into our realm as psychiatrists as mental health emergency calls are handled by the police and not by mental health professionals. The result is sometimes tragic: As many as half of police shootings involve people with psychiatric disorders, and the hope is that many of the police shootings could be avoided if crises were handed by mental health clinicians instead of, or in cooperation with, the police.

At best, police officers receive a week of specialized, crisis intervention training about how to approach those with psychiatric disorders; most officers receive no training. This leaves psychiatry as the only field where medical crises are routinely handled by the police – it is demeaning and embarrassing for some of our patients and dangerous for others. The reality remains, however, that there are times when psychiatric disorders result in violent behavior, and patients being taken for involuntary treatment often resist transport, so either way there is risk, both to the patient and to anyone who responds to a call for assistance.

Early this month, the office of New York City Mayor Bill de Blasio announced that a major change would be made in how mental health calls to 911 are handled in two “high-need” areas. The mayor’s website states:

“Beginning in February 2021, new Mental Health Teams will use their physical and mental health expertise, and experience in crisis response to de-escalate emergency situations, will help reduce the number of times police will need to respond to 911 mental health calls in these precincts. These teams will have the expertise to respond to a range of behavioral health problems, such as suicide attempts, substance misuse, and serious mental illness, as well as physical health problems, which can be exacerbated by or mask mental health problems. NYC Health + Hospitals will train and provide ongoing technical assistance and support. In selecting team members for this program, FDNY will prioritize professionals with significant experience with mental health crises.”

The press release goes on to say that, in situations where there is a weapon or reason to believe there is a risk of violence, the police will be dispatched along with the new mental health team.

“This is the first time in our history that health professionals will be the default responders to mental health emergencies,” New York City First Lady Chirlane McCray said as she announced the new program. “Treating mental health crises as mental health challenges and not public safety ones is the modern and more appropriate approach.”

New York City is not the first city to employ this model. In the United States, the CAHOOTS (Crisis Assistance Helping Out on the Streets) program in Eugene, Ore., has been run by the White Bird Clinic since 1989 as part of a community policing initiative. Last year, the team responded to 24,000 calls and police backup was required on only 150 of those responses. The CAHOOTS website states:

“The CAHOOTS model has been in the spotlight recently as our nation struggles to reimagine public safety. The program mobilizes two-person teams consisting of a medic (a nurse, paramedic, or EMT) and a crisis worker who has substantial training and experience in the mental health field. The CAHOOTS teams deal with a wide range of mental health-related crises, including conflict resolution, welfare checks, substance abuse, suicide threats, and more, relying on trauma-informed de-escalation and harm reduction techniques. CAHOOTS staff are not law enforcement officers and do not carry weapons; their training and experience are the tools they use to ensure a non-violent resolution of crisis situations. They also handle non-emergent medical issues, avoiding costly ambulance transport and emergency room treatment.”

Other cities in the United States are also looking at implementing programs where mental health teams, and not the police, respond to emergency calls. Last year, Oakland, Calif.’s city council invested $40,000 in research to assess how they could best implement a program like the one in Eugene. They hope to begin the Mobile Assistance Community Responders of Oakland (MACROS) next year. Sigal Samuel writes in a Vox article, “The goal is to launch the pilot next year with funding from the city budget, and although supporters are not yet sure what its size and duration will be, they’re hopeful it’ll make a big difference to Oakland’s overpoliced community of people without homes. They were among those who first called for a non-policing approach.”

The model is not unique to the United States. In 2005, Stockholm started a program with a psychiatric ambulance – equipped with comfortable seating rather than a stretcher – to respond to mental health emergencies. The ambulance responds to 130 calls a month. It is staffed with a driver and two psychiatric nurses, and for half of the calls, the police also come. While the Swedish program was not about removing resources from the police, it has relieved the police of the responsibility for many psychiatric emergencies.

The New York City program will be modeled after the CAHOOTS initiative in Eugene. It differs from the mobile crisis response services in many other cities because CAHOOTS is hooked directly into the 911 emergency services system. Its website notes that the program has saved money:

“The cost savings are considerable. The CAHOOTS program budget is about $2.1 million annually, while the combined annual budgets for the Eugene and Springfield police departments are $90 million. In 2017, the CAHOOTS teams answered 17% of the Eugene Police Department’s overall call volume. The program saves the city of Eugene an estimated $8.5 million in public safety spending annually.”

Some worry there is an unpredictable aspect to calls for psychiatric emergencies, and the potential for mental health professions to be injured or killed. Annette Hanson, MD, a forensic psychiatrist at University of Maryland, Baltimore, voiced her concerns, “While multidisciplinary teams are useful, there have been rare cases of violence against responding mental health providers. People with serious mental illness are rarely violent but their dangerousness is unpredictable and cannot be predicted by case screening.”

Daniel Felts is a mental health crisis counselor who has worked at CAHOOTS for the past 4* years. He has responded to about 8,000 calls, and called for police backup only three times to request an immediate "Code 3 cover" when someone's safety has been in danger. Mr. Felts calls the police about once a month for concerns that do not require an immediate response for safety.* “Over the last 4 years, I am only aware of three instances when a team member’s safety was compromised because of a client’s violent behavior. No employee has been seriously physically harmed. In 30 years, with hundreds of thousands (millions?) of calls responded to, no CAHOOTS worker has ever been killed, shot, or stabbed in the line of duty,” Mr. Felts noted.

Emergency calls are screened. “It is not uncommon for CAHOOTS to be dispatched to ‘stage’ for calls involving active disputes or acutely suicidal individuals where means are present. “Staging” entails us parking roughly a mile away while police make first contact and advise whether it is safe for CAHOOTS to engage.”

Mr. Felts went on to discuss the program’s relationship with the community. “I believe that one of the biggest things that keeps us safe is the community’s knowledge and understanding of our service and how we operate. Having operated in Eugene for 30 years, our service is well understood to be one that does not kill, harm, or violate personal boundaries or liberties.”

Would a program like the ones in Stockholm or in Eugene work in other places? Eugene is a city with a population of 172,000 with a low crime rate. Whether a program implemented in one city can be mimicked in another very different city is not clear.

Paul Appelbaum, MD, a forensic psychiatrist at Columbia University, New York, is optimistic about New York City’s forthcoming program.

“The proposed pilot project in NYC is a real step forward. Work that we’ve done looking at fatal encounters involving the police found that roughly 25% of all deaths at the hands of the police are of people with mental illness. In many of those cases, police were initially called to bring people who were clearly troubled for psychiatric evaluation, but as the situation escalated, the police turned to their weapons to control it, which led to a fatal outcome. Taking police out of the picture whenever possible in favor of trained mental health personnel is clearly a better approach. It will be important for the city to collect good outcome data to enable independent evaluation of the pilot project – not something that political entities are inclined toward, but a critical element in assessing the effectiveness of this approach.”

There are questions that remain about the new program. Mayor de Blasio’s office has not released information about which areas of the city are being chosen for the new program, how much the program will cost, or what the funding source will be. If it can be implemented safely and effectively, it has the potential to provide more sensitive care to patients in crisis, and to save lives.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

*Correction, 11/27/2020: An earlier version of this article misstated the number of years Daniel Felts has worked at CAHOOTS.

The human monoclonal antibody golimumab (Simponi) preserved endogenous insulin secretion in patients with new-onset type 1 diabetes and reduced their exogenous insulin requirements at 1 year, newly published phase 2 data indicate.

Results from the multicenter, double-blind, placebo-controlled trial were first reported as a poster at the virtual American Diabetes Association 80th Scientific Sessions in June. They were published online Nov. 18 in the New England Journal of Medicine.

In the 52-week study of 84 children and adults with new-onset type 1 diabetes, those given golimumab injections every 2 weeks had significantly higher levels of C-peptide, a marker of insulin secretion, and required less injected or infused insulin than did those who received placebo injections. There were no treatment-associated serious adverse events.

Golimumab is a human monoclonal antibody specific for tumor necrosis factor–alpha. It is approved for the treatment of several autoimmune diseases, including rheumatoid arthritis and ulcerative colitis, in the United States, Europe, and elsewhere.
 

An intermediate step toward a cure

Although none of the patients were able to stop taking insulin entirely, the results have important clinical implications, lead author Teresa Quattrin, MD, said in an interview.

“People want a cure, but the fact is, a cure is not available yet. So, this is an intermediate step towards a cure.... There are advantages to being on a small insulin dose,” including lower rates of hypoglycemia and maintenance of intraportal insulin, said Dr. Quattrin, of the State University of New York at Buffalo.

But in an accompanying editorial, Domenico Accili, MD, points to potential risks from immunotherapy and from attempting additional interventions at an “emotionally fraught” time when patients and families are coping with the new diabetes diagnosis.

He said of golimumab, “the effect is actually very small. ... There’s nothing wrong in and of itself with improving those outcomes. I just wouldn’t assign them as game changers.”

If this or a similar immunotherapeutic intervention were approved for this indication, “I would tell patients it exists and let them make the decision whether they want to try it. I wouldn’t say you must try it,” said Dr. Accili, of the Columbia University Diabetes and Endocrinology Research Center, New York.
 

With golimumab, higher C-peptide, lower insulin requirement

Of the 84 patients, who ranged in age from 6 to 21 years, 56 were randomly assigned within 100 days of being diagnosed with type 1 diabetes to receive golimumab, and 28 were assigned to receive placebo injections, given every 2 weeks.

The drug resulted in lower insulin use (0.51U/Kg per day vs. 0.69 U/kg per day), and the increase in insulin use over 52 weeks was less with golimumab than with placebo (0.07 vs. 0.24 U/kg per day; P = .001).

The mean percent decrease of C-peptide production from baseline was 12% with golimumab versus 56% with placebo.

Although the mean number of overall hypoglycemic events was similar, the mean number of level 2 hypoglycemic events (<54 mg/dL) was 36% lower with golimumab (11.5 vs. 17.6). There were no severe cases of hypoglycemia in either group.

No severe or serious infections occurred in either group, although mild to moderate infections were reported in 71% with golimumab versus 61% with placebo. More patients in the golimumab group experienced a decrease in neutrophils (29% vs. 19%).
 

Immunotherapy: Which one, and when should it start?

These findings come on the heels of the 2019 landmark results with another monoclonal antibody, the investigational anti-CD3 teplizumab (PRV-031). Among patients at risk, a diagnosis of type 1 diabetes was delayed by 2 years, and continued benefit was seen at 3 years.

However, Dr. Quattrin said teplizumab is limited by the fact that it must be administered via a 14-day infusion, whereas golimumab can be injected by patients themselves at home.

Moreover, the phase 2 teplizumab study was conducted in people who had antibodies that placed them at high risk for type 1 diabetes, but those patients did not yet have the condition. They were identified because they had close relatives with type 1 diabetes and were enrolled in the federally funded TrialNet screening program.

Dr. Quattrin is now participating in an ongoing phase 3 study of teplizumab that involves patients newly diagnosed with type 1 diabetes.

A Janssen spokesperson said in an interview that the company isn’t planning to further develop golimumab for use in type 1 diabetes.

“Our focus is to apply insights from the phase 2 ... proof-of-concept study to progress what we believe are novel, immunologically targeted pipeline candidates in stage 2 disease or presymptomatic stages of type 1 diabetes, which is consistent with our mission to intercept and prevent type 1 diabetes,” the spokesperson said.

To identify more individuals at risk for type 1 diabetes beyond the close relatives of those who already have it, so as to be able to intervene at a presymptomatic stage, Janssen is organizing a public-private effort to advocate for routine population screening for type 1 diabetes–related autoantibodies.

Dr. Quattrin said: “Preserving some insulin is key. Having somebody with beta cell functioning still is an intermediate step to a cure and will make their life easier, and that’s what people should care about.”

Dr. Accili, who cofounded and leads a company working on a novel approach to type 1 diabetes treatment, writes in his editorial: “We should also be mindful that this treatment debate is first world–centric.

“Current treatments for type 1 diabetes require resources not readily available in most parts of the world, where something as simple as refrigeration of insulin can become a logistic nightmare. While combinations of [approaches] tailored to individual risk and potential benefits are likely to make inroads in clinical practice, the need for a simpler, safer, and equally effective alternative to insulin remains,” he wrote.

Dr. Quattrin is a researcher and consultant for Janssen and conducts clinical trials for Provention Bio, Opko, and Ascendis. Dr. Accili is founder and director of Forkhead Therapeutics.

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

The human monoclonal antibody golimumab (Simponi) preserved endogenous insulin secretion in patients with new-onset type 1 diabetes and reduced their exogenous insulin requirements at 1 year, newly published phase 2 data indicate.

Results from the multicenter, double-blind, placebo-controlled trial were first reported as a poster at the virtual American Diabetes Association 80th Scientific Sessions in June. They were published online Nov. 18 in the New England Journal of Medicine.

In the 52-week study of 84 children and adults with new-onset type 1 diabetes, those given golimumab injections every 2 weeks had significantly higher levels of C-peptide, a marker of insulin secretion, and required less injected or infused insulin than did those who received placebo injections. There were no treatment-associated serious adverse events.

Golimumab is a human monoclonal antibody specific for tumor necrosis factor–alpha. It is approved for the treatment of several autoimmune diseases, including rheumatoid arthritis and ulcerative colitis, in the United States, Europe, and elsewhere.
 

An intermediate step toward a cure

Although none of the patients were able to stop taking insulin entirely, the results have important clinical implications, lead author Teresa Quattrin, MD, said in an interview.

“People want a cure, but the fact is, a cure is not available yet. So, this is an intermediate step towards a cure.... There are advantages to being on a small insulin dose,” including lower rates of hypoglycemia and maintenance of intraportal insulin, said Dr. Quattrin, of the State University of New York at Buffalo.

But in an accompanying editorial, Domenico Accili, MD, points to potential risks from immunotherapy and from attempting additional interventions at an “emotionally fraught” time when patients and families are coping with the new diabetes diagnosis.

He said of golimumab, “the effect is actually very small. ... There’s nothing wrong in and of itself with improving those outcomes. I just wouldn’t assign them as game changers.”

If this or a similar immunotherapeutic intervention were approved for this indication, “I would tell patients it exists and let them make the decision whether they want to try it. I wouldn’t say you must try it,” said Dr. Accili, of the Columbia University Diabetes and Endocrinology Research Center, New York.
 

With golimumab, higher C-peptide, lower insulin requirement

Of the 84 patients, who ranged in age from 6 to 21 years, 56 were randomly assigned within 100 days of being diagnosed with type 1 diabetes to receive golimumab, and 28 were assigned to receive placebo injections, given every 2 weeks.

The drug resulted in lower insulin use (0.51U/Kg per day vs. 0.69 U/kg per day), and the increase in insulin use over 52 weeks was less with golimumab than with placebo (0.07 vs. 0.24 U/kg per day; P = .001).

The mean percent decrease of C-peptide production from baseline was 12% with golimumab versus 56% with placebo.

Although the mean number of overall hypoglycemic events was similar, the mean number of level 2 hypoglycemic events (<54 mg/dL) was 36% lower with golimumab (11.5 vs. 17.6). There were no severe cases of hypoglycemia in either group.

No severe or serious infections occurred in either group, although mild to moderate infections were reported in 71% with golimumab versus 61% with placebo. More patients in the golimumab group experienced a decrease in neutrophils (29% vs. 19%).
 

Immunotherapy: Which one, and when should it start?

These findings come on the heels of the 2019 landmark results with another monoclonal antibody, the investigational anti-CD3 teplizumab (PRV-031). Among patients at risk, a diagnosis of type 1 diabetes was delayed by 2 years, and continued benefit was seen at 3 years.

However, Dr. Quattrin said teplizumab is limited by the fact that it must be administered via a 14-day infusion, whereas golimumab can be injected by patients themselves at home.

Moreover, the phase 2 teplizumab study was conducted in people who had antibodies that placed them at high risk for type 1 diabetes, but those patients did not yet have the condition. They were identified because they had close relatives with type 1 diabetes and were enrolled in the federally funded TrialNet screening program.

Dr. Quattrin is now participating in an ongoing phase 3 study of teplizumab that involves patients newly diagnosed with type 1 diabetes.

A Janssen spokesperson said in an interview that the company isn’t planning to further develop golimumab for use in type 1 diabetes.

“Our focus is to apply insights from the phase 2 ... proof-of-concept study to progress what we believe are novel, immunologically targeted pipeline candidates in stage 2 disease or presymptomatic stages of type 1 diabetes, which is consistent with our mission to intercept and prevent type 1 diabetes,” the spokesperson said.

To identify more individuals at risk for type 1 diabetes beyond the close relatives of those who already have it, so as to be able to intervene at a presymptomatic stage, Janssen is organizing a public-private effort to advocate for routine population screening for type 1 diabetes–related autoantibodies.

Dr. Quattrin said: “Preserving some insulin is key. Having somebody with beta cell functioning still is an intermediate step to a cure and will make their life easier, and that’s what people should care about.”

Dr. Accili, who cofounded and leads a company working on a novel approach to type 1 diabetes treatment, writes in his editorial: “We should also be mindful that this treatment debate is first world–centric.

“Current treatments for type 1 diabetes require resources not readily available in most parts of the world, where something as simple as refrigeration of insulin can become a logistic nightmare. While combinations of [approaches] tailored to individual risk and potential benefits are likely to make inroads in clinical practice, the need for a simpler, safer, and equally effective alternative to insulin remains,” he wrote.

Dr. Quattrin is a researcher and consultant for Janssen and conducts clinical trials for Provention Bio, Opko, and Ascendis. Dr. Accili is founder and director of Forkhead Therapeutics.

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

The human monoclonal antibody golimumab (Simponi) preserved endogenous insulin secretion in patients with new-onset type 1 diabetes and reduced their exogenous insulin requirements at 1 year, newly published phase 2 data indicate.

Results from the multicenter, double-blind, placebo-controlled trial were first reported as a poster at the virtual American Diabetes Association 80th Scientific Sessions in June. They were published online Nov. 18 in the New England Journal of Medicine.

In the 52-week study of 84 children and adults with new-onset type 1 diabetes, those given golimumab injections every 2 weeks had significantly higher levels of C-peptide, a marker of insulin secretion, and required less injected or infused insulin than did those who received placebo injections. There were no treatment-associated serious adverse events.

Golimumab is a human monoclonal antibody specific for tumor necrosis factor–alpha. It is approved for the treatment of several autoimmune diseases, including rheumatoid arthritis and ulcerative colitis, in the United States, Europe, and elsewhere.
 

An intermediate step toward a cure

Although none of the patients were able to stop taking insulin entirely, the results have important clinical implications, lead author Teresa Quattrin, MD, said in an interview.

“People want a cure, but the fact is, a cure is not available yet. So, this is an intermediate step towards a cure.... There are advantages to being on a small insulin dose,” including lower rates of hypoglycemia and maintenance of intraportal insulin, said Dr. Quattrin, of the State University of New York at Buffalo.

But in an accompanying editorial, Domenico Accili, MD, points to potential risks from immunotherapy and from attempting additional interventions at an “emotionally fraught” time when patients and families are coping with the new diabetes diagnosis.

He said of golimumab, “the effect is actually very small. ... There’s nothing wrong in and of itself with improving those outcomes. I just wouldn’t assign them as game changers.”

If this or a similar immunotherapeutic intervention were approved for this indication, “I would tell patients it exists and let them make the decision whether they want to try it. I wouldn’t say you must try it,” said Dr. Accili, of the Columbia University Diabetes and Endocrinology Research Center, New York.
 

With golimumab, higher C-peptide, lower insulin requirement

Of the 84 patients, who ranged in age from 6 to 21 years, 56 were randomly assigned within 100 days of being diagnosed with type 1 diabetes to receive golimumab, and 28 were assigned to receive placebo injections, given every 2 weeks.

The drug resulted in lower insulin use (0.51U/Kg per day vs. 0.69 U/kg per day), and the increase in insulin use over 52 weeks was less with golimumab than with placebo (0.07 vs. 0.24 U/kg per day; P = .001).

The mean percent decrease of C-peptide production from baseline was 12% with golimumab versus 56% with placebo.

Although the mean number of overall hypoglycemic events was similar, the mean number of level 2 hypoglycemic events (<54 mg/dL) was 36% lower with golimumab (11.5 vs. 17.6). There were no severe cases of hypoglycemia in either group.

No severe or serious infections occurred in either group, although mild to moderate infections were reported in 71% with golimumab versus 61% with placebo. More patients in the golimumab group experienced a decrease in neutrophils (29% vs. 19%).
 

Immunotherapy: Which one, and when should it start?

These findings come on the heels of the 2019 landmark results with another monoclonal antibody, the investigational anti-CD3 teplizumab (PRV-031). Among patients at risk, a diagnosis of type 1 diabetes was delayed by 2 years, and continued benefit was seen at 3 years.

However, Dr. Quattrin said teplizumab is limited by the fact that it must be administered via a 14-day infusion, whereas golimumab can be injected by patients themselves at home.

Moreover, the phase 2 teplizumab study was conducted in people who had antibodies that placed them at high risk for type 1 diabetes, but those patients did not yet have the condition. They were identified because they had close relatives with type 1 diabetes and were enrolled in the federally funded TrialNet screening program.

Dr. Quattrin is now participating in an ongoing phase 3 study of teplizumab that involves patients newly diagnosed with type 1 diabetes.

A Janssen spokesperson said in an interview that the company isn’t planning to further develop golimumab for use in type 1 diabetes.

“Our focus is to apply insights from the phase 2 ... proof-of-concept study to progress what we believe are novel, immunologically targeted pipeline candidates in stage 2 disease or presymptomatic stages of type 1 diabetes, which is consistent with our mission to intercept and prevent type 1 diabetes,” the spokesperson said.

To identify more individuals at risk for type 1 diabetes beyond the close relatives of those who already have it, so as to be able to intervene at a presymptomatic stage, Janssen is organizing a public-private effort to advocate for routine population screening for type 1 diabetes–related autoantibodies.

Dr. Quattrin said: “Preserving some insulin is key. Having somebody with beta cell functioning still is an intermediate step to a cure and will make their life easier, and that’s what people should care about.”

Dr. Accili, who cofounded and leads a company working on a novel approach to type 1 diabetes treatment, writes in his editorial: “We should also be mindful that this treatment debate is first world–centric.

“Current treatments for type 1 diabetes require resources not readily available in most parts of the world, where something as simple as refrigeration of insulin can become a logistic nightmare. While combinations of [approaches] tailored to individual risk and potential benefits are likely to make inroads in clinical practice, the need for a simpler, safer, and equally effective alternative to insulin remains,” he wrote.

Dr. Quattrin is a researcher and consultant for Janssen and conducts clinical trials for Provention Bio, Opko, and Ascendis. Dr. Accili is founder and director of Forkhead Therapeutics.

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

Delirium should be included on checklists of the presenting signs and symptoms of COVID-19, particularly in elderly adults, according to a multicenter study of seniors visiting emergency departments.

Overall, 28% of the 817 older adults who presented to the emergency department and were diagnosed with COVID-19 had delirium, according to a study published online November 19 in JAMA Network Open. Moreover, 16% of these patients had delirium that was not accompanied by typical symptoms or signs of SARS-CoV-2 infection.

Among patients with delirium, there was a greater probability of admission to the intensive care unit compared with patients who presented without delirium (adjusted relative risk [aRR], 1.67; 95% CI, 1.30 – 2.15), as well as a greater probability of death (aRR, 1.24; 95% CI, 1.00 – 1.55).

“These findings suggest the clinical importance of including delirium on checklists of presenting signs and symptoms of COVID-19 that guide screening, testing, and evaluation,” write Maura Kennedy, MD, MPH, and colleagues.

“I was absolutely seeing cases of delirium where there were no other symptoms of COVID-19, but we didn’t have lot of data on the frequency of this,” explained Kennedy, an emergency department physician at Massachusetts General Hospital and an assistant professor of emergency medicine at Harvard Medical School, Boston.

“And the rate was somewhat surprising compared with that seen in non-COVID studies of delirium, but then our study population was more at risk, coming from long-term care facilities and having prior stroke or dementia,” she said. The most common form of delirium was hypoactive sleepiness and nonresponsiveness, although hyperactivity and agitation were also seen.

Kennedy thinks the addition of delirium as a common presenting symptom to diagnostic checklists would prevent some cases from being missed and allow earlier identification and management of COVID-19 patients at high risk for poor outcomes. “We certainly don’t want to send them back undiagnosed to a long-term care facility or promote transmission within the hospital,” she told Medscape Medical News.

That step has already been implemented in some US centers. “Delirium is something we’ve been looking at since the early summer,” said geriatrician Angela Catic, MD, an assistant professor at Baylor College of Medicine’s Huffington Center on Aging and the Michael E. DeBakey VA Medical Center, Houston, Texas.

“If we see delirium, we’re looking for COVID-19,” said Catic, who was not involved in the study.

In Catic’s experience, it is “not at all atypical” to see patients whose only symptom of COVID-19 is delirium. As with other infections and diseases, “the aging brain is incredibly vulnerable,” she said.

According to William W. Hung, MD, MPH, an assistant professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai, New York City, delirium is “generally a common sign of something seriously wrong” in older adults. “In the case of COVID-19, low oxygenation caused by the infection may play a role,” he told Medscape Medical News. Although he agreed that delirium should be included in the differential diagnosis of COVID-19, how frequently it is the only symptom at presentation would need to be determined in a considerably larger population, he said.

Joining the company of those observing this COVID-19 manifestation is Christopher R. Carpenter, MD, a professor of emergency medicine at Washington University in St. Louis, St. Louis, Missouri. He was not a participant in the current study.

“I have absolutely seen and documented delirium as the presenting complaint in older adult patients who were ultimately diagnosed with SARS-CoV-2, and since March, I contemplate SARS-CoV-2 each time I identify delirium,” Carpenter told Medscape Medical News. “Honestly, I ― and most of my colleagues ― are considering SARS-CoV-2 for a range of symptoms and complaints these days, because of the odd presentations we’ve all encountered.”
 

Study details

For the study, Kennedy and colleagues enrolled consecutive adults aged 65 years and older who were diagnosed with active COVID-19 and who presented to emergency departments at seven centers in Massachusetts, Maine, Connecticut, Michigan, and North Carolina on or after March 13, 2020. Active infection with SARS-CoV-2 was determined on the basis of results of nasal swab polymerase chain reaction tests (99% of cases) or the appearance and distribution of ground-glass opacities on chest radiography or CT (1%).

Of the 817 patients enrolled, 386 (47%) were men, 493 (62%) were White, 215 (27%) were Black, and 54 (7%) were Hispanic or Latinx. The mean age of patients was 77.7 years (standard deviation, 8.2). Their age placed them at risk for chronic comorbidities and cognitive problems; indeed, 15% had at least four chronic conditions, and 30% had existing cognitive impairment.

The authors note that among the 226 patients (28%) who had delirium at presentation, 60 (27%) had experienced delirium for a duration of 2 to 7 days.

Additionally, of the 226 patients who exhibited delirium as a primary symptom, 84 (37%) showed no typical COVID-19 symptoms or signs, such as cough, fever, or shortness of breath.

The presence of delirium did not correlate with any of the typical COVID-19 symptoms in particular; Kennedy noted that only 56% of patients in the cohort had a fever at presentation.

Delirium at presentation was significantly associated with a median hospital stay of more than 8 days (aRR, 1.14; 95% CI, .97 – 1.35) and a greater risk for discharge to a rehabilitation facility (aRR, 1.55; 95% CI, 1.07 – 2.26). Factors associated with delirium included age older than 75 years, residence in a nursing home or assisted-living facility, previous use of psychoactive medications, vision impairment, hearing impairment, stroke, and Parkinson’s disease.

Kennedy noted that the rate of delirium observed in this study is much higher than that generally reported in emergency department studies conducted before the COVID-19 pandemic. In those studies, the delirium rate ranged from 7% to 20%. The associated risk factors, however, are comparable.

“Mounting evidence supports the high occurrence of delirium and other neuropsychiatric manifestations with COVID-19, with previously reported rates of 22% to 33% among hospitalized patients,” Kennedy and associates write.

In Carpenter’s opinion, the development of incident delirium while receiving care in the emergency department, as opposed to delirium at the time of presentation, has been exacerbated by the no-visitor policies mandated by the pandemic, which have prevented visits even from personal caregivers of patients with moderate to severe dementia. “Although healthcare systems need to be cognizant of the risk of spread to uninfected caregivers, there’s a risk-benefit balance that must be found, because having one caregiver at the bedside can prevent delirium in cognitively impaired patients,” said Carpenter, who was not involved in the current study.

Among the barriers to improving the situation, Carpenter cited the lack of routine delirium screening and the absence of high-quality evidence to support emergency department interventions to mitigate delirium.

“Layer those challenges on top of COVID-19’s rapidly evolving diagnostic landscape, frequent atypical presentations, and asymptomatic carriers across all age groups and the negative impact of delirium is magnified,” Carpenter said.

Once elderly patients are hospitalized, Kennedy recommends the nonpharmacologic guidelines of the Hospital Elder Life Program for reducing delirium risk. Recommendations include the providing of adequate sleep, hydration, and nutrition, as well as function restoration, precipitant avoidance, and reorientation.

The study was supported in part by the National Institute on Aging and the Massachusetts Medical School. The authors, Carpenter, Hung, and Catic have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delirium should be included on checklists of the presenting signs and symptoms of COVID-19, particularly in elderly adults, according to a multicenter study of seniors visiting emergency departments.

Overall, 28% of the 817 older adults who presented to the emergency department and were diagnosed with COVID-19 had delirium, according to a study published online November 19 in JAMA Network Open. Moreover, 16% of these patients had delirium that was not accompanied by typical symptoms or signs of SARS-CoV-2 infection.

Among patients with delirium, there was a greater probability of admission to the intensive care unit compared with patients who presented without delirium (adjusted relative risk [aRR], 1.67; 95% CI, 1.30 – 2.15), as well as a greater probability of death (aRR, 1.24; 95% CI, 1.00 – 1.55).

“These findings suggest the clinical importance of including delirium on checklists of presenting signs and symptoms of COVID-19 that guide screening, testing, and evaluation,” write Maura Kennedy, MD, MPH, and colleagues.

“I was absolutely seeing cases of delirium where there were no other symptoms of COVID-19, but we didn’t have lot of data on the frequency of this,” explained Kennedy, an emergency department physician at Massachusetts General Hospital and an assistant professor of emergency medicine at Harvard Medical School, Boston.

“And the rate was somewhat surprising compared with that seen in non-COVID studies of delirium, but then our study population was more at risk, coming from long-term care facilities and having prior stroke or dementia,” she said. The most common form of delirium was hypoactive sleepiness and nonresponsiveness, although hyperactivity and agitation were also seen.

Kennedy thinks the addition of delirium as a common presenting symptom to diagnostic checklists would prevent some cases from being missed and allow earlier identification and management of COVID-19 patients at high risk for poor outcomes. “We certainly don’t want to send them back undiagnosed to a long-term care facility or promote transmission within the hospital,” she told Medscape Medical News.

That step has already been implemented in some US centers. “Delirium is something we’ve been looking at since the early summer,” said geriatrician Angela Catic, MD, an assistant professor at Baylor College of Medicine’s Huffington Center on Aging and the Michael E. DeBakey VA Medical Center, Houston, Texas.

“If we see delirium, we’re looking for COVID-19,” said Catic, who was not involved in the study.

In Catic’s experience, it is “not at all atypical” to see patients whose only symptom of COVID-19 is delirium. As with other infections and diseases, “the aging brain is incredibly vulnerable,” she said.

According to William W. Hung, MD, MPH, an assistant professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai, New York City, delirium is “generally a common sign of something seriously wrong” in older adults. “In the case of COVID-19, low oxygenation caused by the infection may play a role,” he told Medscape Medical News. Although he agreed that delirium should be included in the differential diagnosis of COVID-19, how frequently it is the only symptom at presentation would need to be determined in a considerably larger population, he said.

Joining the company of those observing this COVID-19 manifestation is Christopher R. Carpenter, MD, a professor of emergency medicine at Washington University in St. Louis, St. Louis, Missouri. He was not a participant in the current study.

“I have absolutely seen and documented delirium as the presenting complaint in older adult patients who were ultimately diagnosed with SARS-CoV-2, and since March, I contemplate SARS-CoV-2 each time I identify delirium,” Carpenter told Medscape Medical News. “Honestly, I ― and most of my colleagues ― are considering SARS-CoV-2 for a range of symptoms and complaints these days, because of the odd presentations we’ve all encountered.”
 

Study details

For the study, Kennedy and colleagues enrolled consecutive adults aged 65 years and older who were diagnosed with active COVID-19 and who presented to emergency departments at seven centers in Massachusetts, Maine, Connecticut, Michigan, and North Carolina on or after March 13, 2020. Active infection with SARS-CoV-2 was determined on the basis of results of nasal swab polymerase chain reaction tests (99% of cases) or the appearance and distribution of ground-glass opacities on chest radiography or CT (1%).

Of the 817 patients enrolled, 386 (47%) were men, 493 (62%) were White, 215 (27%) were Black, and 54 (7%) were Hispanic or Latinx. The mean age of patients was 77.7 years (standard deviation, 8.2). Their age placed them at risk for chronic comorbidities and cognitive problems; indeed, 15% had at least four chronic conditions, and 30% had existing cognitive impairment.

The authors note that among the 226 patients (28%) who had delirium at presentation, 60 (27%) had experienced delirium for a duration of 2 to 7 days.

Additionally, of the 226 patients who exhibited delirium as a primary symptom, 84 (37%) showed no typical COVID-19 symptoms or signs, such as cough, fever, or shortness of breath.

The presence of delirium did not correlate with any of the typical COVID-19 symptoms in particular; Kennedy noted that only 56% of patients in the cohort had a fever at presentation.

Delirium at presentation was significantly associated with a median hospital stay of more than 8 days (aRR, 1.14; 95% CI, .97 – 1.35) and a greater risk for discharge to a rehabilitation facility (aRR, 1.55; 95% CI, 1.07 – 2.26). Factors associated with delirium included age older than 75 years, residence in a nursing home or assisted-living facility, previous use of psychoactive medications, vision impairment, hearing impairment, stroke, and Parkinson’s disease.

Kennedy noted that the rate of delirium observed in this study is much higher than that generally reported in emergency department studies conducted before the COVID-19 pandemic. In those studies, the delirium rate ranged from 7% to 20%. The associated risk factors, however, are comparable.

“Mounting evidence supports the high occurrence of delirium and other neuropsychiatric manifestations with COVID-19, with previously reported rates of 22% to 33% among hospitalized patients,” Kennedy and associates write.

In Carpenter’s opinion, the development of incident delirium while receiving care in the emergency department, as opposed to delirium at the time of presentation, has been exacerbated by the no-visitor policies mandated by the pandemic, which have prevented visits even from personal caregivers of patients with moderate to severe dementia. “Although healthcare systems need to be cognizant of the risk of spread to uninfected caregivers, there’s a risk-benefit balance that must be found, because having one caregiver at the bedside can prevent delirium in cognitively impaired patients,” said Carpenter, who was not involved in the current study.

Among the barriers to improving the situation, Carpenter cited the lack of routine delirium screening and the absence of high-quality evidence to support emergency department interventions to mitigate delirium.

“Layer those challenges on top of COVID-19’s rapidly evolving diagnostic landscape, frequent atypical presentations, and asymptomatic carriers across all age groups and the negative impact of delirium is magnified,” Carpenter said.

Once elderly patients are hospitalized, Kennedy recommends the nonpharmacologic guidelines of the Hospital Elder Life Program for reducing delirium risk. Recommendations include the providing of adequate sleep, hydration, and nutrition, as well as function restoration, precipitant avoidance, and reorientation.

The study was supported in part by the National Institute on Aging and the Massachusetts Medical School. The authors, Carpenter, Hung, and Catic have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delirium should be included on checklists of the presenting signs and symptoms of COVID-19, particularly in elderly adults, according to a multicenter study of seniors visiting emergency departments.

Overall, 28% of the 817 older adults who presented to the emergency department and were diagnosed with COVID-19 had delirium, according to a study published online November 19 in JAMA Network Open. Moreover, 16% of these patients had delirium that was not accompanied by typical symptoms or signs of SARS-CoV-2 infection.

Among patients with delirium, there was a greater probability of admission to the intensive care unit compared with patients who presented without delirium (adjusted relative risk [aRR], 1.67; 95% CI, 1.30 – 2.15), as well as a greater probability of death (aRR, 1.24; 95% CI, 1.00 – 1.55).

“These findings suggest the clinical importance of including delirium on checklists of presenting signs and symptoms of COVID-19 that guide screening, testing, and evaluation,” write Maura Kennedy, MD, MPH, and colleagues.

“I was absolutely seeing cases of delirium where there were no other symptoms of COVID-19, but we didn’t have lot of data on the frequency of this,” explained Kennedy, an emergency department physician at Massachusetts General Hospital and an assistant professor of emergency medicine at Harvard Medical School, Boston.

“And the rate was somewhat surprising compared with that seen in non-COVID studies of delirium, but then our study population was more at risk, coming from long-term care facilities and having prior stroke or dementia,” she said. The most common form of delirium was hypoactive sleepiness and nonresponsiveness, although hyperactivity and agitation were also seen.

Kennedy thinks the addition of delirium as a common presenting symptom to diagnostic checklists would prevent some cases from being missed and allow earlier identification and management of COVID-19 patients at high risk for poor outcomes. “We certainly don’t want to send them back undiagnosed to a long-term care facility or promote transmission within the hospital,” she told Medscape Medical News.

That step has already been implemented in some US centers. “Delirium is something we’ve been looking at since the early summer,” said geriatrician Angela Catic, MD, an assistant professor at Baylor College of Medicine’s Huffington Center on Aging and the Michael E. DeBakey VA Medical Center, Houston, Texas.

“If we see delirium, we’re looking for COVID-19,” said Catic, who was not involved in the study.

In Catic’s experience, it is “not at all atypical” to see patients whose only symptom of COVID-19 is delirium. As with other infections and diseases, “the aging brain is incredibly vulnerable,” she said.

According to William W. Hung, MD, MPH, an assistant professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai, New York City, delirium is “generally a common sign of something seriously wrong” in older adults. “In the case of COVID-19, low oxygenation caused by the infection may play a role,” he told Medscape Medical News. Although he agreed that delirium should be included in the differential diagnosis of COVID-19, how frequently it is the only symptom at presentation would need to be determined in a considerably larger population, he said.

Joining the company of those observing this COVID-19 manifestation is Christopher R. Carpenter, MD, a professor of emergency medicine at Washington University in St. Louis, St. Louis, Missouri. He was not a participant in the current study.

“I have absolutely seen and documented delirium as the presenting complaint in older adult patients who were ultimately diagnosed with SARS-CoV-2, and since March, I contemplate SARS-CoV-2 each time I identify delirium,” Carpenter told Medscape Medical News. “Honestly, I ― and most of my colleagues ― are considering SARS-CoV-2 for a range of symptoms and complaints these days, because of the odd presentations we’ve all encountered.”
 

Study details

For the study, Kennedy and colleagues enrolled consecutive adults aged 65 years and older who were diagnosed with active COVID-19 and who presented to emergency departments at seven centers in Massachusetts, Maine, Connecticut, Michigan, and North Carolina on or after March 13, 2020. Active infection with SARS-CoV-2 was determined on the basis of results of nasal swab polymerase chain reaction tests (99% of cases) or the appearance and distribution of ground-glass opacities on chest radiography or CT (1%).

Of the 817 patients enrolled, 386 (47%) were men, 493 (62%) were White, 215 (27%) were Black, and 54 (7%) were Hispanic or Latinx. The mean age of patients was 77.7 years (standard deviation, 8.2). Their age placed them at risk for chronic comorbidities and cognitive problems; indeed, 15% had at least four chronic conditions, and 30% had existing cognitive impairment.

The authors note that among the 226 patients (28%) who had delirium at presentation, 60 (27%) had experienced delirium for a duration of 2 to 7 days.

Additionally, of the 226 patients who exhibited delirium as a primary symptom, 84 (37%) showed no typical COVID-19 symptoms or signs, such as cough, fever, or shortness of breath.

The presence of delirium did not correlate with any of the typical COVID-19 symptoms in particular; Kennedy noted that only 56% of patients in the cohort had a fever at presentation.

Delirium at presentation was significantly associated with a median hospital stay of more than 8 days (aRR, 1.14; 95% CI, .97 – 1.35) and a greater risk for discharge to a rehabilitation facility (aRR, 1.55; 95% CI, 1.07 – 2.26). Factors associated with delirium included age older than 75 years, residence in a nursing home or assisted-living facility, previous use of psychoactive medications, vision impairment, hearing impairment, stroke, and Parkinson’s disease.

Kennedy noted that the rate of delirium observed in this study is much higher than that generally reported in emergency department studies conducted before the COVID-19 pandemic. In those studies, the delirium rate ranged from 7% to 20%. The associated risk factors, however, are comparable.

“Mounting evidence supports the high occurrence of delirium and other neuropsychiatric manifestations with COVID-19, with previously reported rates of 22% to 33% among hospitalized patients,” Kennedy and associates write.

In Carpenter’s opinion, the development of incident delirium while receiving care in the emergency department, as opposed to delirium at the time of presentation, has been exacerbated by the no-visitor policies mandated by the pandemic, which have prevented visits even from personal caregivers of patients with moderate to severe dementia. “Although healthcare systems need to be cognizant of the risk of spread to uninfected caregivers, there’s a risk-benefit balance that must be found, because having one caregiver at the bedside can prevent delirium in cognitively impaired patients,” said Carpenter, who was not involved in the current study.

Among the barriers to improving the situation, Carpenter cited the lack of routine delirium screening and the absence of high-quality evidence to support emergency department interventions to mitigate delirium.

“Layer those challenges on top of COVID-19’s rapidly evolving diagnostic landscape, frequent atypical presentations, and asymptomatic carriers across all age groups and the negative impact of delirium is magnified,” Carpenter said.

Once elderly patients are hospitalized, Kennedy recommends the nonpharmacologic guidelines of the Hospital Elder Life Program for reducing delirium risk. Recommendations include the providing of adequate sleep, hydration, and nutrition, as well as function restoration, precipitant avoidance, and reorientation.

The study was supported in part by the National Institute on Aging and the Massachusetts Medical School. The authors, Carpenter, Hung, and Catic have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Lowering blood pressure for patients with intracerebral hemorrhage (ICH) does not improve functional recovery, a systematic review and meta-analysis shows, although it does reduce hematoma growth in these patients.

Despite the negative finding, the investigators observed broad variation in treatment effect among the studies they reviewed. They also found that target-based blood pressure treatment tended to improve function more than fixed-dose treatment.

“These data provide a strong message that early blood pressure–lowering treatment can control bleeding. This was not clear beforehand,” Craig Anderson, PhD, professor of neurology and epidemiology at the University of New South Wales, Sydney, said in an interview.

“But these data also indicate that the management of blood pressure in ICH is complex,” he added. Timing, type of drug, and type of patient must be considered, he said. “We need more data to allow better individualizing of such therapy.”

The results were presented at the European Stroke Organisation–World Stroke Organisation (ESO-WSO) Conference 2020.

Controversy about the efficacy of blood pressure reduction for patients with ICH continues, despite studies that have examined this question. In this analysis, Dr. Anderson and colleagues sought to examine the evidence from randomized controlled trials in this area and identify potentially overlooked heterogeneity among trials.

The investigators conducted a systematic review and meta-analysis of studies in the Cochrane Central Register of Controlled Trials, EMBASE, and MEDLINE databases. They searched for randomized controlled trials of blood pressure management for adults with acute ICH, focusing on studies in which patients were enrolled within 7 days of ICH onset. These studies compared intensive blood pressure management with guideline-based management.

Investigators chose function, defined as Modified Rankin Scale (mRS) score at 90 days, as their primary outcome. Radiologic outcomes included absolute (>6 mL) and proportional (>33%) hematoma growth at 24 hours. They used the intention to treat dataset from each trial in their statistical analyses and created generalized linear mixed models with prespecified covariables using a one-stage approach.
 

Variation by drug

A total of 7,094 studies were identified, of which 50 were eligible for inclusion. Their analysis encompassed 16 studies for which the respective investigators were willing to share patient-level data. The analysis included data on 6,221 patients. The mean age of the patients was 64.2 years, 36.4% were women, and the median time from symptom onset to randomization was 3.8 hours.

Mean National Institutes of Health Stroke Scale score was approximately 11. Mean systolic blood pressure at baseline was 177 mm Hg, and mean hematoma volume was approximately 10.6 mL.

The difference in blood pressure between the intensive and guideline groups was approximately 8 mm Hg at 1 hour and 12 mm Hg at 24 hours.

Intensive blood pressure management did not affect function at 90 days. The adjusted odds ratio for unfavorable shift in mRS scores was 0.97 (95% CI, 0.88-1.06; P = .503). Intensive blood pressure management did, however, reduce hematoma growth (absolute aOR, 0.75; 95% CI, 0.60-0.92; P = .007; relative aOR, 0.82; 95% CI, 0.68-0.99; P = .034).

In prespecified subgroup analyses, they found a trend toward adverse outcomes among patients who received renin-angiotensin blockers and a trend toward benefit for patients who received alpha- or beta-receptor antagonists or calcium channel blockers. They did not observe a clear association between time of treatment and outcome.

In addition to hematoma growth, other factors influence prognosis after ICH, such as the patient’s status before ICH (for example, cardiovascular risk factors, age, and hypertensive effects on the brain, kidneys, and heart), the location of ICH and its effects on surrounding structures, and complications of care in hospitals, such as infection and bleeding, said Dr. Anderson.

They are conducting two ongoing clinical trials in patients with ICH. One, INTERACT3, is evaluating a “care bundle” quality control package that includes early intensive blood pressure lowering for patients with large ICH who undergo surgery.

The other, INTERACT4, is evaluating early blood pressure control in the ambulance for patients with suspected acute stroke. At least one-fifth of those patients will have ICH, said Dr. Anderson.
 

Prevention is essential

Among patients with ICH, much of the bleeding occurs before presentation at the hospital, Louis R. Caplan, MD, a neurologist at Beth Israel Deaconess Medical Center, Boston, said in an interview. Furthermore, the bleeding mainly occurs in the deep part of the brain where most of the important motor tracts are. “If those tracts are already hit, a little extra blood isn’t going to change things,” said Dr. Caplan, who was not involved in the research.

In addition, blood is pushed from inside the brain to the periphery until the pressure outside the brain is equal to the pressure inside it. “You can decrease the amount of bleeding significantly, but it probably doesn’t affect the outcome,” said Dr. Caplan.

One factor in patients’ apparent lack of functional improvement is that the mRS is not sensitive to minor changes in disability, he said. “You have to show a pretty important change for it to make a difference,” said Dr. Caplan.

In addition, recovery from a hemorrhage takes much longer than recovery from an infarct. Examining the population at 6 months would have been preferable to examining them at 90 days, but the investigators might not have 6-month data, said Dr. Caplan.

“The main thing is really prevention,” he concluded.

The study was conducted with funding from Takeda. Dr. Anderson reported receiving funding from the National Health and Medical Research Council of Australia and speaker fees from Takeda. Dr. Caplan has disclosed no relevant financial relationships.

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

Lowering blood pressure for patients with intracerebral hemorrhage (ICH) does not improve functional recovery, a systematic review and meta-analysis shows, although it does reduce hematoma growth in these patients.

Despite the negative finding, the investigators observed broad variation in treatment effect among the studies they reviewed. They also found that target-based blood pressure treatment tended to improve function more than fixed-dose treatment.

“These data provide a strong message that early blood pressure–lowering treatment can control bleeding. This was not clear beforehand,” Craig Anderson, PhD, professor of neurology and epidemiology at the University of New South Wales, Sydney, said in an interview.

“But these data also indicate that the management of blood pressure in ICH is complex,” he added. Timing, type of drug, and type of patient must be considered, he said. “We need more data to allow better individualizing of such therapy.”

The results were presented at the European Stroke Organisation–World Stroke Organisation (ESO-WSO) Conference 2020.

Controversy about the efficacy of blood pressure reduction for patients with ICH continues, despite studies that have examined this question. In this analysis, Dr. Anderson and colleagues sought to examine the evidence from randomized controlled trials in this area and identify potentially overlooked heterogeneity among trials.

The investigators conducted a systematic review and meta-analysis of studies in the Cochrane Central Register of Controlled Trials, EMBASE, and MEDLINE databases. They searched for randomized controlled trials of blood pressure management for adults with acute ICH, focusing on studies in which patients were enrolled within 7 days of ICH onset. These studies compared intensive blood pressure management with guideline-based management.

Investigators chose function, defined as Modified Rankin Scale (mRS) score at 90 days, as their primary outcome. Radiologic outcomes included absolute (>6 mL) and proportional (>33%) hematoma growth at 24 hours. They used the intention to treat dataset from each trial in their statistical analyses and created generalized linear mixed models with prespecified covariables using a one-stage approach.
 

Variation by drug

A total of 7,094 studies were identified, of which 50 were eligible for inclusion. Their analysis encompassed 16 studies for which the respective investigators were willing to share patient-level data. The analysis included data on 6,221 patients. The mean age of the patients was 64.2 years, 36.4% were women, and the median time from symptom onset to randomization was 3.8 hours.

Mean National Institutes of Health Stroke Scale score was approximately 11. Mean systolic blood pressure at baseline was 177 mm Hg, and mean hematoma volume was approximately 10.6 mL.

The difference in blood pressure between the intensive and guideline groups was approximately 8 mm Hg at 1 hour and 12 mm Hg at 24 hours.

Intensive blood pressure management did not affect function at 90 days. The adjusted odds ratio for unfavorable shift in mRS scores was 0.97 (95% CI, 0.88-1.06; P = .503). Intensive blood pressure management did, however, reduce hematoma growth (absolute aOR, 0.75; 95% CI, 0.60-0.92; P = .007; relative aOR, 0.82; 95% CI, 0.68-0.99; P = .034).

In prespecified subgroup analyses, they found a trend toward adverse outcomes among patients who received renin-angiotensin blockers and a trend toward benefit for patients who received alpha- or beta-receptor antagonists or calcium channel blockers. They did not observe a clear association between time of treatment and outcome.

In addition to hematoma growth, other factors influence prognosis after ICH, such as the patient’s status before ICH (for example, cardiovascular risk factors, age, and hypertensive effects on the brain, kidneys, and heart), the location of ICH and its effects on surrounding structures, and complications of care in hospitals, such as infection and bleeding, said Dr. Anderson.

They are conducting two ongoing clinical trials in patients with ICH. One, INTERACT3, is evaluating a “care bundle” quality control package that includes early intensive blood pressure lowering for patients with large ICH who undergo surgery.

The other, INTERACT4, is evaluating early blood pressure control in the ambulance for patients with suspected acute stroke. At least one-fifth of those patients will have ICH, said Dr. Anderson.
 

Prevention is essential

Among patients with ICH, much of the bleeding occurs before presentation at the hospital, Louis R. Caplan, MD, a neurologist at Beth Israel Deaconess Medical Center, Boston, said in an interview. Furthermore, the bleeding mainly occurs in the deep part of the brain where most of the important motor tracts are. “If those tracts are already hit, a little extra blood isn’t going to change things,” said Dr. Caplan, who was not involved in the research.

In addition, blood is pushed from inside the brain to the periphery until the pressure outside the brain is equal to the pressure inside it. “You can decrease the amount of bleeding significantly, but it probably doesn’t affect the outcome,” said Dr. Caplan.

One factor in patients’ apparent lack of functional improvement is that the mRS is not sensitive to minor changes in disability, he said. “You have to show a pretty important change for it to make a difference,” said Dr. Caplan.

In addition, recovery from a hemorrhage takes much longer than recovery from an infarct. Examining the population at 6 months would have been preferable to examining them at 90 days, but the investigators might not have 6-month data, said Dr. Caplan.

“The main thing is really prevention,” he concluded.

The study was conducted with funding from Takeda. Dr. Anderson reported receiving funding from the National Health and Medical Research Council of Australia and speaker fees from Takeda. Dr. Caplan has disclosed no relevant financial relationships.

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

Lowering blood pressure for patients with intracerebral hemorrhage (ICH) does not improve functional recovery, a systematic review and meta-analysis shows, although it does reduce hematoma growth in these patients.

Despite the negative finding, the investigators observed broad variation in treatment effect among the studies they reviewed. They also found that target-based blood pressure treatment tended to improve function more than fixed-dose treatment.

“These data provide a strong message that early blood pressure–lowering treatment can control bleeding. This was not clear beforehand,” Craig Anderson, PhD, professor of neurology and epidemiology at the University of New South Wales, Sydney, said in an interview.

“But these data also indicate that the management of blood pressure in ICH is complex,” he added. Timing, type of drug, and type of patient must be considered, he said. “We need more data to allow better individualizing of such therapy.”

The results were presented at the European Stroke Organisation–World Stroke Organisation (ESO-WSO) Conference 2020.

Controversy about the efficacy of blood pressure reduction for patients with ICH continues, despite studies that have examined this question. In this analysis, Dr. Anderson and colleagues sought to examine the evidence from randomized controlled trials in this area and identify potentially overlooked heterogeneity among trials.

The investigators conducted a systematic review and meta-analysis of studies in the Cochrane Central Register of Controlled Trials, EMBASE, and MEDLINE databases. They searched for randomized controlled trials of blood pressure management for adults with acute ICH, focusing on studies in which patients were enrolled within 7 days of ICH onset. These studies compared intensive blood pressure management with guideline-based management.

Investigators chose function, defined as Modified Rankin Scale (mRS) score at 90 days, as their primary outcome. Radiologic outcomes included absolute (>6 mL) and proportional (>33%) hematoma growth at 24 hours. They used the intention to treat dataset from each trial in their statistical analyses and created generalized linear mixed models with prespecified covariables using a one-stage approach.
 

Variation by drug

A total of 7,094 studies were identified, of which 50 were eligible for inclusion. Their analysis encompassed 16 studies for which the respective investigators were willing to share patient-level data. The analysis included data on 6,221 patients. The mean age of the patients was 64.2 years, 36.4% were women, and the median time from symptom onset to randomization was 3.8 hours.

Mean National Institutes of Health Stroke Scale score was approximately 11. Mean systolic blood pressure at baseline was 177 mm Hg, and mean hematoma volume was approximately 10.6 mL.

The difference in blood pressure between the intensive and guideline groups was approximately 8 mm Hg at 1 hour and 12 mm Hg at 24 hours.

Intensive blood pressure management did not affect function at 90 days. The adjusted odds ratio for unfavorable shift in mRS scores was 0.97 (95% CI, 0.88-1.06; P = .503). Intensive blood pressure management did, however, reduce hematoma growth (absolute aOR, 0.75; 95% CI, 0.60-0.92; P = .007; relative aOR, 0.82; 95% CI, 0.68-0.99; P = .034).

In prespecified subgroup analyses, they found a trend toward adverse outcomes among patients who received renin-angiotensin blockers and a trend toward benefit for patients who received alpha- or beta-receptor antagonists or calcium channel blockers. They did not observe a clear association between time of treatment and outcome.

In addition to hematoma growth, other factors influence prognosis after ICH, such as the patient’s status before ICH (for example, cardiovascular risk factors, age, and hypertensive effects on the brain, kidneys, and heart), the location of ICH and its effects on surrounding structures, and complications of care in hospitals, such as infection and bleeding, said Dr. Anderson.

They are conducting two ongoing clinical trials in patients with ICH. One, INTERACT3, is evaluating a “care bundle” quality control package that includes early intensive blood pressure lowering for patients with large ICH who undergo surgery.

The other, INTERACT4, is evaluating early blood pressure control in the ambulance for patients with suspected acute stroke. At least one-fifth of those patients will have ICH, said Dr. Anderson.
 

Prevention is essential

Among patients with ICH, much of the bleeding occurs before presentation at the hospital, Louis R. Caplan, MD, a neurologist at Beth Israel Deaconess Medical Center, Boston, said in an interview. Furthermore, the bleeding mainly occurs in the deep part of the brain where most of the important motor tracts are. “If those tracts are already hit, a little extra blood isn’t going to change things,” said Dr. Caplan, who was not involved in the research.

In addition, blood is pushed from inside the brain to the periphery until the pressure outside the brain is equal to the pressure inside it. “You can decrease the amount of bleeding significantly, but it probably doesn’t affect the outcome,” said Dr. Caplan.

One factor in patients’ apparent lack of functional improvement is that the mRS is not sensitive to minor changes in disability, he said. “You have to show a pretty important change for it to make a difference,” said Dr. Caplan.

In addition, recovery from a hemorrhage takes much longer than recovery from an infarct. Examining the population at 6 months would have been preferable to examining them at 90 days, but the investigators might not have 6-month data, said Dr. Caplan.

“The main thing is really prevention,” he concluded.

The study was conducted with funding from Takeda. Dr. Anderson reported receiving funding from the National Health and Medical Research Council of Australia and speaker fees from Takeda. Dr. Caplan has disclosed no relevant financial relationships.

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

Contrary to historical evidence, among older people, elevated LDL cholesterol levels increase risk for heart attack and cardiovascular disease, and older patients benefit as much, if not more, from statins and other cholesterol-lowering drugs than do younger people, two new studies show.

“By contrast with previous historical studies, our data show that LDL cholesterol is an important risk factor for myocardial infarction and atherosclerotic cardiovascular disease in a contemporary primary prevention cohort of individuals aged 70 to 100 years,” Borge Nordestgaard, MD, of the University of Copenhagen, and colleagues noted in the first of the two studies, published this week in the Lancet.

“By lowering LDL cholesterol in healthy individuals aged 70-100 years, the potential for preventing myocardial infarctions and atherosclerotic cardiovascular disease is huge, and at a substantially lower number needed to treat when compared with those aged 20-69 years,” they added.

“These findings support the concept of the cumulative burden of LDL cholesterol over one’s lifetime and the progressive increase in risk for atherosclerotic cardiovascular disease, including myocardial infarction, with age,” added Frederick J. Raal, PhD, and Farzahna Mohamed, MB BCh, of the University of the Witwatersrand, Johannesburg, South Africa, in an editorial published with both new studies in the Lancet (2020 Nov 10. doi: 10.1016/S0140-6736[20]32333-3).

The studies underscore the need for clinicians to consider continued risks associated with elevated LDL cholesterol in older age, they stressed, adding that statins are also beneficial for younger persons at risk to prevent conditions from worsening.

“The average age of patients in all the trials analyzed was older than 60 years, an age when atherosclerotic cardiovascular disease is already well established,” the editorialists wrote.

“Lipid-lowering therapy should be initiated at a younger age, preferably before age 40 years, in those at risk to delay the onset of atherosclerosis, rather than try to manage the condition once fully established or advanced,” they stressed.
 

No RCTs have included patients older than 70

For persons aged 40-75 years, elevated LDL cholesterol levels are a known risk factor for MI and atherosclerotic cardiovascular disease, and there is consensus in guidelines regarding treatment with statins.

However, the risk for people older than 70 is controversial. Some studies show little or no association between elevated LDL cholesterol levels and an increased risk for MI.

Contributing to the uncertainty is that few of the randomized, controlled trials that have investigated the question have included patients aged older than 70 years.

As a consequence, many practice guidelines have noted that the level of evidence in older patients is low, and some organizations have lowered the strength of recommendations regarding the treatment for older patients in comparison with younger patients.
 

Primary prevention: CV events increase with elevated LDL cholesterol in older age

Dr. Nordestgaard and colleagues studied data on 91,131 people living in Copenhagen who did not have atherosclerotic cardiovascular disease or diabetes at baseline and were not taking statins.

Of the participants, 10,592 were aged 70-79 years, and 3,188 participants were aged 80-100 years.

Over an average follow-up period of 7.7 years, 1,515 participants had a first MI, and 3,389 developed atherosclerotic cardiovascular disease.

In the primary-prevention cohort, after multivariate adjustment, the risk of having a heart attack per 1.0 mmol/L increase in LDL cholesterol was increased in the group overall (hazard ratio, 1.34). The increased risk was observed for all age groups, including those aged 80-100 years (HR, 1.28), 70-79 (HR, 1.25), 60-69 (HR, 1.29), 50-59 (HR, 1.28), and 20-49 (HR, 1.68).

Risk for atherosclerotic cardiovascular disease was also raised per 1.0 mmol/L increase in LDL cholesterol overall (HR, 1.16) and in all age groups, particularly those aged 70-100 years.

Greater elevations in LDL cholesterol (5.0 mmol/L or higher, indicative of possible familial hypercholesterolemia) were associated with a notably higher risk for heart attack after multivariate adjustment in people aged 80-100 (HR, 2.99). Risk was also higher among those aged 70-79 (HR, 1.82).

The highest incidence was in those older than 70. The rate was 8.5 heart attacks per 1,000 people per year among those aged 80-100 and 5.2 heart attacks per 1,000 in those aged 70-79. The rates were 2.5 per 1,000 among those 60-69, 1.8 for those aged 50-59, and 0.8 for those aged 20-49.

“The absolute risk [of cardiovascular events] is of course much higher in the elderly than those under the age of 75, but what was a surprise was how clear our results were on a relative risk scale, that the risk associated with elevated LDL [cholesterol] was as high in people aged 80-100 as the younger patients,” Dr. Nordestgaard said in an interview.

With regard to the benefits of cholesterol-lowering drugs, the study showed that the number needed to prevent one heart attack over 5 years was 80 among those aged 80-100; the number was 439 for people aged 50-59.

With regard to stronger statins, when moderate-intensity statins were used, the number needed to treat to prevent one cardiovascular disease event of any type dropped to 42 for patients aged 80-100. It was 88 for those aged 70-79, 164 for those aged 60-69, 345 for those aged 50-59, and 769 for those aged 20-49.

“The clinical significance of this is that it appears those in older age groups indeed benefit from cholesterol-lowering therapy,” Dr. Nordestgaard said. “I think many people have this idea that LDL [cholesterol] is not important over the age of about 70-75, but that’s not the case.”

“These robust findings are novel,” he and his colleagues stressed.

Despite these observational findings, the South African editorialists noted that “whether lipid-lowering therapy should be initiated for primary prevention in people aged 75 years or older is unclear,” owing to the host of risks and benefits that need to be balanced.

The findings of an ongoing randomized, placebo-controlled trial (STAREE) may answer this question, they wrote. It is investigating primary prevention in 18,000 older patients (≥70 years) who are being randomly assigned to receive atorvastatin 40 mg/d or placebo. The study is seeking to determine whether statin treatment extends the length of a disability-free life, which will be assessed on the basis of survival outside permanent residential care. Results are expected in 2022-2023.
 

Unequivocal reductions in events in elderly, comparable with younger patients

In the second study (Lancet. 2020 Nov 10. doi: 10.1016/S0140-6736[20]32332-1), Baris Gencer, MD, of Brigham and Women’s Hospital, Boston, =and colleagues evaluated the effects of statins and other cholesterol-lowering drugs, including ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors, in older versus younger patients.

The systematic review and meta-analysis of 29 randomized controlled trials, also published in the Lancet, were presented virtually as a poster as part of the 2020 American Heart Association scientific session. It included data on 244,090 patients, including 21,492 aged 75 years and older.

The meta-analysis included studies of cardiovascular outcomes of a guideline-recommended LDL cholesterol–lowering drug, with a median follow-up of at least 2 years and inclusion of data on patients aged 75 years and older.

The results showed that over a median follow-up of 2.2 to 6 years, statin use by older patients was associated with a relative risk reduction of major vascular events of 26% per 1 mmol/L reduction in LDL cholesterol (P = .0019), which was comparable with a risk reduction of 15% per 1 mmol/L reduction in LDL cholesterol for patients younger than 75 years (P = .37, compared with older patients).

Treatment of older patients with LDL cholesterol–lowering drugs was also associated with significantly improved outcomes in cardiovascular death (risk ratio, 0.85), MI (RR, 0.80), stroke (RR, 0.73), and coronary revascularization (RR, 0.80).

“We found an unequivocal reduction in the risk of major vascular events with both statin and nonstatin LDL cholesterol-lowering treatments, which was similar to that seen in younger patients,” the authors wrote.

“Cholesterol-lowering medications are affordable drugs that have reduced risk of heart disease for millions of people worldwide, but until now, their benefits for older people have remained less certain,” said lead author Marc Sabatine, MD, also of Brigham and Women’s Hospital, in a Lancet press release.

“Our analysis indicates that these therapies are as effective in reducing cardiovascular events and deaths in people aged 75 years and over as they are in younger people. We found no offsetting safety concerns, and together, these results should strengthen guideline recommendations for the use of cholesterol-lowering medications, including statin and nonstatin therapy, in elderly people.”

The editorialists agreed: “More than 80% of fatal cardiovascular events occur in individuals older than 65 years, and the incidence of cardiovascular events is increasing in those older than 80 years; therefore, the findings of Gencer and colleagues’ study should encourage the use of lipid-lowering therapy in older patients.”

The authors of the two studies have disclosed no relevant financial relationships. Dr. Raal has received research grants, honoraria, or consulting fees for advisory board membership, professional input, and lectures on lipid-lowering drug therapy from Amgen, Regeneron, Sanofi, Novartis, and the Medicines Company.

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

Contrary to historical evidence, among older people, elevated LDL cholesterol levels increase risk for heart attack and cardiovascular disease, and older patients benefit as much, if not more, from statins and other cholesterol-lowering drugs than do younger people, two new studies show.

“By contrast with previous historical studies, our data show that LDL cholesterol is an important risk factor for myocardial infarction and atherosclerotic cardiovascular disease in a contemporary primary prevention cohort of individuals aged 70 to 100 years,” Borge Nordestgaard, MD, of the University of Copenhagen, and colleagues noted in the first of the two studies, published this week in the Lancet.

“By lowering LDL cholesterol in healthy individuals aged 70-100 years, the potential for preventing myocardial infarctions and atherosclerotic cardiovascular disease is huge, and at a substantially lower number needed to treat when compared with those aged 20-69 years,” they added.

“These findings support the concept of the cumulative burden of LDL cholesterol over one’s lifetime and the progressive increase in risk for atherosclerotic cardiovascular disease, including myocardial infarction, with age,” added Frederick J. Raal, PhD, and Farzahna Mohamed, MB BCh, of the University of the Witwatersrand, Johannesburg, South Africa, in an editorial published with both new studies in the Lancet (2020 Nov 10. doi: 10.1016/S0140-6736[20]32333-3).

The studies underscore the need for clinicians to consider continued risks associated with elevated LDL cholesterol in older age, they stressed, adding that statins are also beneficial for younger persons at risk to prevent conditions from worsening.

“The average age of patients in all the trials analyzed was older than 60 years, an age when atherosclerotic cardiovascular disease is already well established,” the editorialists wrote.

“Lipid-lowering therapy should be initiated at a younger age, preferably before age 40 years, in those at risk to delay the onset of atherosclerosis, rather than try to manage the condition once fully established or advanced,” they stressed.
 

No RCTs have included patients older than 70

For persons aged 40-75 years, elevated LDL cholesterol levels are a known risk factor for MI and atherosclerotic cardiovascular disease, and there is consensus in guidelines regarding treatment with statins.

However, the risk for people older than 70 is controversial. Some studies show little or no association between elevated LDL cholesterol levels and an increased risk for MI.

Contributing to the uncertainty is that few of the randomized, controlled trials that have investigated the question have included patients aged older than 70 years.

As a consequence, many practice guidelines have noted that the level of evidence in older patients is low, and some organizations have lowered the strength of recommendations regarding the treatment for older patients in comparison with younger patients.
 

Primary prevention: CV events increase with elevated LDL cholesterol in older age

Dr. Nordestgaard and colleagues studied data on 91,131 people living in Copenhagen who did not have atherosclerotic cardiovascular disease or diabetes at baseline and were not taking statins.

Of the participants, 10,592 were aged 70-79 years, and 3,188 participants were aged 80-100 years.

Over an average follow-up period of 7.7 years, 1,515 participants had a first MI, and 3,389 developed atherosclerotic cardiovascular disease.

In the primary-prevention cohort, after multivariate adjustment, the risk of having a heart attack per 1.0 mmol/L increase in LDL cholesterol was increased in the group overall (hazard ratio, 1.34). The increased risk was observed for all age groups, including those aged 80-100 years (HR, 1.28), 70-79 (HR, 1.25), 60-69 (HR, 1.29), 50-59 (HR, 1.28), and 20-49 (HR, 1.68).

Risk for atherosclerotic cardiovascular disease was also raised per 1.0 mmol/L increase in LDL cholesterol overall (HR, 1.16) and in all age groups, particularly those aged 70-100 years.

Greater elevations in LDL cholesterol (5.0 mmol/L or higher, indicative of possible familial hypercholesterolemia) were associated with a notably higher risk for heart attack after multivariate adjustment in people aged 80-100 (HR, 2.99). Risk was also higher among those aged 70-79 (HR, 1.82).

The highest incidence was in those older than 70. The rate was 8.5 heart attacks per 1,000 people per year among those aged 80-100 and 5.2 heart attacks per 1,000 in those aged 70-79. The rates were 2.5 per 1,000 among those 60-69, 1.8 for those aged 50-59, and 0.8 for those aged 20-49.

“The absolute risk [of cardiovascular events] is of course much higher in the elderly than those under the age of 75, but what was a surprise was how clear our results were on a relative risk scale, that the risk associated with elevated LDL [cholesterol] was as high in people aged 80-100 as the younger patients,” Dr. Nordestgaard said in an interview.

With regard to the benefits of cholesterol-lowering drugs, the study showed that the number needed to prevent one heart attack over 5 years was 80 among those aged 80-100; the number was 439 for people aged 50-59.

With regard to stronger statins, when moderate-intensity statins were used, the number needed to treat to prevent one cardiovascular disease event of any type dropped to 42 for patients aged 80-100. It was 88 for those aged 70-79, 164 for those aged 60-69, 345 for those aged 50-59, and 769 for those aged 20-49.

“The clinical significance of this is that it appears those in older age groups indeed benefit from cholesterol-lowering therapy,” Dr. Nordestgaard said. “I think many people have this idea that LDL [cholesterol] is not important over the age of about 70-75, but that’s not the case.”

“These robust findings are novel,” he and his colleagues stressed.

Despite these observational findings, the South African editorialists noted that “whether lipid-lowering therapy should be initiated for primary prevention in people aged 75 years or older is unclear,” owing to the host of risks and benefits that need to be balanced.

The findings of an ongoing randomized, placebo-controlled trial (STAREE) may answer this question, they wrote. It is investigating primary prevention in 18,000 older patients (≥70 years) who are being randomly assigned to receive atorvastatin 40 mg/d or placebo. The study is seeking to determine whether statin treatment extends the length of a disability-free life, which will be assessed on the basis of survival outside permanent residential care. Results are expected in 2022-2023.
 

Unequivocal reductions in events in elderly, comparable with younger patients

In the second study (Lancet. 2020 Nov 10. doi: 10.1016/S0140-6736[20]32332-1), Baris Gencer, MD, of Brigham and Women’s Hospital, Boston, =and colleagues evaluated the effects of statins and other cholesterol-lowering drugs, including ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors, in older versus younger patients.

The systematic review and meta-analysis of 29 randomized controlled trials, also published in the Lancet, were presented virtually as a poster as part of the 2020 American Heart Association scientific session. It included data on 244,090 patients, including 21,492 aged 75 years and older.

The meta-analysis included studies of cardiovascular outcomes of a guideline-recommended LDL cholesterol–lowering drug, with a median follow-up of at least 2 years and inclusion of data on patients aged 75 years and older.

The results showed that over a median follow-up of 2.2 to 6 years, statin use by older patients was associated with a relative risk reduction of major vascular events of 26% per 1 mmol/L reduction in LDL cholesterol (P = .0019), which was comparable with a risk reduction of 15% per 1 mmol/L reduction in LDL cholesterol for patients younger than 75 years (P = .37, compared with older patients).

Treatment of older patients with LDL cholesterol–lowering drugs was also associated with significantly improved outcomes in cardiovascular death (risk ratio, 0.85), MI (RR, 0.80), stroke (RR, 0.73), and coronary revascularization (RR, 0.80).

“We found an unequivocal reduction in the risk of major vascular events with both statin and nonstatin LDL cholesterol-lowering treatments, which was similar to that seen in younger patients,” the authors wrote.

“Cholesterol-lowering medications are affordable drugs that have reduced risk of heart disease for millions of people worldwide, but until now, their benefits for older people have remained less certain,” said lead author Marc Sabatine, MD, also of Brigham and Women’s Hospital, in a Lancet press release.

“Our analysis indicates that these therapies are as effective in reducing cardiovascular events and deaths in people aged 75 years and over as they are in younger people. We found no offsetting safety concerns, and together, these results should strengthen guideline recommendations for the use of cholesterol-lowering medications, including statin and nonstatin therapy, in elderly people.”

The editorialists agreed: “More than 80% of fatal cardiovascular events occur in individuals older than 65 years, and the incidence of cardiovascular events is increasing in those older than 80 years; therefore, the findings of Gencer and colleagues’ study should encourage the use of lipid-lowering therapy in older patients.”

The authors of the two studies have disclosed no relevant financial relationships. Dr. Raal has received research grants, honoraria, or consulting fees for advisory board membership, professional input, and lectures on lipid-lowering drug therapy from Amgen, Regeneron, Sanofi, Novartis, and the Medicines Company.

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

Contrary to historical evidence, among older people, elevated LDL cholesterol levels increase risk for heart attack and cardiovascular disease, and older patients benefit as much, if not more, from statins and other cholesterol-lowering drugs than do younger people, two new studies show.

“By contrast with previous historical studies, our data show that LDL cholesterol is an important risk factor for myocardial infarction and atherosclerotic cardiovascular disease in a contemporary primary prevention cohort of individuals aged 70 to 100 years,” Borge Nordestgaard, MD, of the University of Copenhagen, and colleagues noted in the first of the two studies, published this week in the Lancet.

“By lowering LDL cholesterol in healthy individuals aged 70-100 years, the potential for preventing myocardial infarctions and atherosclerotic cardiovascular disease is huge, and at a substantially lower number needed to treat when compared with those aged 20-69 years,” they added.

“These findings support the concept of the cumulative burden of LDL cholesterol over one’s lifetime and the progressive increase in risk for atherosclerotic cardiovascular disease, including myocardial infarction, with age,” added Frederick J. Raal, PhD, and Farzahna Mohamed, MB BCh, of the University of the Witwatersrand, Johannesburg, South Africa, in an editorial published with both new studies in the Lancet (2020 Nov 10. doi: 10.1016/S0140-6736[20]32333-3).

The studies underscore the need for clinicians to consider continued risks associated with elevated LDL cholesterol in older age, they stressed, adding that statins are also beneficial for younger persons at risk to prevent conditions from worsening.

“The average age of patients in all the trials analyzed was older than 60 years, an age when atherosclerotic cardiovascular disease is already well established,” the editorialists wrote.

“Lipid-lowering therapy should be initiated at a younger age, preferably before age 40 years, in those at risk to delay the onset of atherosclerosis, rather than try to manage the condition once fully established or advanced,” they stressed.
 

No RCTs have included patients older than 70

For persons aged 40-75 years, elevated LDL cholesterol levels are a known risk factor for MI and atherosclerotic cardiovascular disease, and there is consensus in guidelines regarding treatment with statins.

However, the risk for people older than 70 is controversial. Some studies show little or no association between elevated LDL cholesterol levels and an increased risk for MI.

Contributing to the uncertainty is that few of the randomized, controlled trials that have investigated the question have included patients aged older than 70 years.

As a consequence, many practice guidelines have noted that the level of evidence in older patients is low, and some organizations have lowered the strength of recommendations regarding the treatment for older patients in comparison with younger patients.
 

Primary prevention: CV events increase with elevated LDL cholesterol in older age

Dr. Nordestgaard and colleagues studied data on 91,131 people living in Copenhagen who did not have atherosclerotic cardiovascular disease or diabetes at baseline and were not taking statins.

Of the participants, 10,592 were aged 70-79 years, and 3,188 participants were aged 80-100 years.

Over an average follow-up period of 7.7 years, 1,515 participants had a first MI, and 3,389 developed atherosclerotic cardiovascular disease.

In the primary-prevention cohort, after multivariate adjustment, the risk of having a heart attack per 1.0 mmol/L increase in LDL cholesterol was increased in the group overall (hazard ratio, 1.34). The increased risk was observed for all age groups, including those aged 80-100 years (HR, 1.28), 70-79 (HR, 1.25), 60-69 (HR, 1.29), 50-59 (HR, 1.28), and 20-49 (HR, 1.68).

Risk for atherosclerotic cardiovascular disease was also raised per 1.0 mmol/L increase in LDL cholesterol overall (HR, 1.16) and in all age groups, particularly those aged 70-100 years.

Greater elevations in LDL cholesterol (5.0 mmol/L or higher, indicative of possible familial hypercholesterolemia) were associated with a notably higher risk for heart attack after multivariate adjustment in people aged 80-100 (HR, 2.99). Risk was also higher among those aged 70-79 (HR, 1.82).

The highest incidence was in those older than 70. The rate was 8.5 heart attacks per 1,000 people per year among those aged 80-100 and 5.2 heart attacks per 1,000 in those aged 70-79. The rates were 2.5 per 1,000 among those 60-69, 1.8 for those aged 50-59, and 0.8 for those aged 20-49.

“The absolute risk [of cardiovascular events] is of course much higher in the elderly than those under the age of 75, but what was a surprise was how clear our results were on a relative risk scale, that the risk associated with elevated LDL [cholesterol] was as high in people aged 80-100 as the younger patients,” Dr. Nordestgaard said in an interview.

With regard to the benefits of cholesterol-lowering drugs, the study showed that the number needed to prevent one heart attack over 5 years was 80 among those aged 80-100; the number was 439 for people aged 50-59.

With regard to stronger statins, when moderate-intensity statins were used, the number needed to treat to prevent one cardiovascular disease event of any type dropped to 42 for patients aged 80-100. It was 88 for those aged 70-79, 164 for those aged 60-69, 345 for those aged 50-59, and 769 for those aged 20-49.

“The clinical significance of this is that it appears those in older age groups indeed benefit from cholesterol-lowering therapy,” Dr. Nordestgaard said. “I think many people have this idea that LDL [cholesterol] is not important over the age of about 70-75, but that’s not the case.”

“These robust findings are novel,” he and his colleagues stressed.

Despite these observational findings, the South African editorialists noted that “whether lipid-lowering therapy should be initiated for primary prevention in people aged 75 years or older is unclear,” owing to the host of risks and benefits that need to be balanced.

The findings of an ongoing randomized, placebo-controlled trial (STAREE) may answer this question, they wrote. It is investigating primary prevention in 18,000 older patients (≥70 years) who are being randomly assigned to receive atorvastatin 40 mg/d or placebo. The study is seeking to determine whether statin treatment extends the length of a disability-free life, which will be assessed on the basis of survival outside permanent residential care. Results are expected in 2022-2023.
 

Unequivocal reductions in events in elderly, comparable with younger patients

In the second study (Lancet. 2020 Nov 10. doi: 10.1016/S0140-6736[20]32332-1), Baris Gencer, MD, of Brigham and Women’s Hospital, Boston, =and colleagues evaluated the effects of statins and other cholesterol-lowering drugs, including ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors, in older versus younger patients.

The systematic review and meta-analysis of 29 randomized controlled trials, also published in the Lancet, were presented virtually as a poster as part of the 2020 American Heart Association scientific session. It included data on 244,090 patients, including 21,492 aged 75 years and older.

The meta-analysis included studies of cardiovascular outcomes of a guideline-recommended LDL cholesterol–lowering drug, with a median follow-up of at least 2 years and inclusion of data on patients aged 75 years and older.

The results showed that over a median follow-up of 2.2 to 6 years, statin use by older patients was associated with a relative risk reduction of major vascular events of 26% per 1 mmol/L reduction in LDL cholesterol (P = .0019), which was comparable with a risk reduction of 15% per 1 mmol/L reduction in LDL cholesterol for patients younger than 75 years (P = .37, compared with older patients).

Treatment of older patients with LDL cholesterol–lowering drugs was also associated with significantly improved outcomes in cardiovascular death (risk ratio, 0.85), MI (RR, 0.80), stroke (RR, 0.73), and coronary revascularization (RR, 0.80).

“We found an unequivocal reduction in the risk of major vascular events with both statin and nonstatin LDL cholesterol-lowering treatments, which was similar to that seen in younger patients,” the authors wrote.

“Cholesterol-lowering medications are affordable drugs that have reduced risk of heart disease for millions of people worldwide, but until now, their benefits for older people have remained less certain,” said lead author Marc Sabatine, MD, also of Brigham and Women’s Hospital, in a Lancet press release.

“Our analysis indicates that these therapies are as effective in reducing cardiovascular events and deaths in people aged 75 years and over as they are in younger people. We found no offsetting safety concerns, and together, these results should strengthen guideline recommendations for the use of cholesterol-lowering medications, including statin and nonstatin therapy, in elderly people.”

The editorialists agreed: “More than 80% of fatal cardiovascular events occur in individuals older than 65 years, and the incidence of cardiovascular events is increasing in those older than 80 years; therefore, the findings of Gencer and colleagues’ study should encourage the use of lipid-lowering therapy in older patients.”

The authors of the two studies have disclosed no relevant financial relationships. Dr. Raal has received research grants, honoraria, or consulting fees for advisory board membership, professional input, and lectures on lipid-lowering drug therapy from Amgen, Regeneron, Sanofi, Novartis, and the Medicines Company.

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

• Survey reveals special impact of COVID-19 on persons with rare disorders
• Topical treatment tackles oral ulcers in Behçet’s syndrome
• Managing the risk of congenital heart block in anti-Ro/SSA-positive women
• Newly described lung disorder strikes children with systemic juvenile idiopathic arthritis

Read the report here.

• Survey reveals special impact of COVID-19 on persons with rare disorders
• Topical treatment tackles oral ulcers in Behçet’s syndrome
• Managing the risk of congenital heart block in anti-Ro/SSA-positive women
• Newly described lung disorder strikes children with systemic juvenile idiopathic arthritis

Read the report here.

• Survey reveals special impact of COVID-19 on persons with rare disorders
• Topical treatment tackles oral ulcers in Behçet’s syndrome
• Managing the risk of congenital heart block in anti-Ro/SSA-positive women
• Newly described lung disorder strikes children with systemic juvenile idiopathic arthritis

Read the report here.

As far as the pandemic is concerned, it seems like a pretty small thing. A difference of just 0.3%. Children now represent 11.8% of all COVID-19 cases that have occurred since the beginning of the pandemic, compared with 11.5% 1 week ago, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Hiding behind that 0.3%, however, is a much larger number: 144,145. That is the number of new child cases that occurred during the week that ended Nov. 19, and it’s the highest weekly figure yet, eclipsing the previous high of 111,946 from the week of Nov. 12, the AAP and the CHA said in their latest COVID-19 report. For the week ending Nov. 19, children represented 14.1% of all new cases, up from 14.0% the week before.

In the United States, more than 1.18 million children have been infected by the coronavirus since the beginning of the pandemic, with the total among all ages topping 10 million in 49 states (New York is not providing age distribution), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP/CHA data show. That works out to 11.8% of all cases.

The overall rate of child COVID-19 cases is now up to 1,573 per 100,000 children nationally, with considerable variation seen among the states. The lowest rates can be found in Vermont (344 per 100,000), Maine (452), and Hawaii (675), and the highest in North Dakota (5,589), South Dakota (3,993), and Wisconsin (3,727), the AAP and CHA said in the report.

Comparisons between states are somewhat problematic, though, because “each state makes different decisions about how to report the age distribution of COVID-19 cases, and as a result the age range for reported cases varies by state. … It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states at this time,” the two organizations noted.

Five more COVID-19–related deaths in children were reported during the week of Nov. 19, bringing the count to 138 and holding at just 0.06% of the total for all ages, based on data from 43 states and New York City. Children’s share of hospitalizations increased slightly in the last week, rising from 1.7% to 1.8% in the 24 states (and NYC) that are reporting such data. The total number of child hospitalizations in those jurisdictions is just over 6,700, the AAP and CHA said.

[email protected]

As far as the pandemic is concerned, it seems like a pretty small thing. A difference of just 0.3%. Children now represent 11.8% of all COVID-19 cases that have occurred since the beginning of the pandemic, compared with 11.5% 1 week ago, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Hiding behind that 0.3%, however, is a much larger number: 144,145. That is the number of new child cases that occurred during the week that ended Nov. 19, and it’s the highest weekly figure yet, eclipsing the previous high of 111,946 from the week of Nov. 12, the AAP and the CHA said in their latest COVID-19 report. For the week ending Nov. 19, children represented 14.1% of all new cases, up from 14.0% the week before.

In the United States, more than 1.18 million children have been infected by the coronavirus since the beginning of the pandemic, with the total among all ages topping 10 million in 49 states (New York is not providing age distribution), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP/CHA data show. That works out to 11.8% of all cases.

The overall rate of child COVID-19 cases is now up to 1,573 per 100,000 children nationally, with considerable variation seen among the states. The lowest rates can be found in Vermont (344 per 100,000), Maine (452), and Hawaii (675), and the highest in North Dakota (5,589), South Dakota (3,993), and Wisconsin (3,727), the AAP and CHA said in the report.

Comparisons between states are somewhat problematic, though, because “each state makes different decisions about how to report the age distribution of COVID-19 cases, and as a result the age range for reported cases varies by state. … It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states at this time,” the two organizations noted.

Five more COVID-19–related deaths in children were reported during the week of Nov. 19, bringing the count to 138 and holding at just 0.06% of the total for all ages, based on data from 43 states and New York City. Children’s share of hospitalizations increased slightly in the last week, rising from 1.7% to 1.8% in the 24 states (and NYC) that are reporting such data. The total number of child hospitalizations in those jurisdictions is just over 6,700, the AAP and CHA said.

[email protected]

As far as the pandemic is concerned, it seems like a pretty small thing. A difference of just 0.3%. Children now represent 11.8% of all COVID-19 cases that have occurred since the beginning of the pandemic, compared with 11.5% 1 week ago, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Hiding behind that 0.3%, however, is a much larger number: 144,145. That is the number of new child cases that occurred during the week that ended Nov. 19, and it’s the highest weekly figure yet, eclipsing the previous high of 111,946 from the week of Nov. 12, the AAP and the CHA said in their latest COVID-19 report. For the week ending Nov. 19, children represented 14.1% of all new cases, up from 14.0% the week before.

In the United States, more than 1.18 million children have been infected by the coronavirus since the beginning of the pandemic, with the total among all ages topping 10 million in 49 states (New York is not providing age distribution), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP/CHA data show. That works out to 11.8% of all cases.

The overall rate of child COVID-19 cases is now up to 1,573 per 100,000 children nationally, with considerable variation seen among the states. The lowest rates can be found in Vermont (344 per 100,000), Maine (452), and Hawaii (675), and the highest in North Dakota (5,589), South Dakota (3,993), and Wisconsin (3,727), the AAP and CHA said in the report.

Comparisons between states are somewhat problematic, though, because “each state makes different decisions about how to report the age distribution of COVID-19 cases, and as a result the age range for reported cases varies by state. … It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states at this time,” the two organizations noted.

Five more COVID-19–related deaths in children were reported during the week of Nov. 19, bringing the count to 138 and holding at just 0.06% of the total for all ages, based on data from 43 states and New York City. Children’s share of hospitalizations increased slightly in the last week, rising from 1.7% to 1.8% in the 24 states (and NYC) that are reporting such data. The total number of child hospitalizations in those jurisdictions is just over 6,700, the AAP and CHA said.

[email protected]

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

To the Editor:

Cutaneous reactions to implantable devices, such as dental implants, intracoronary stents, prosthetic valves, endovascular prostheses, gynecologic devices, and spinal cord stimulator devices, occur with varying frequency and include infectious, hypersensitivity, allergic, and foreign-body reactions. Manifestations have included contact dermatitis; urticarial, vasculitic, and bullous eruptions; extrusion; and granuloma formation.^1,2 Immune complex reactions around implants causing pain, inflammation, and loosening of hardwarealso have been reported.^3,4 Most reported cutaneous reactions typically occur within the first weeks or months after implantation; a reaction rarely presents several years after implantation. We report a cutaneous reaction to an orthopedic appliance almost 10 years after implantation.

A 67-year-old man presented with 2 painful nodules on the right clavicle that were present for several months. The patient denied fever, chills, weight loss, enlarged lymph nodes, or night sweats. Approximately 10 years prior to the appearance of the nodules, the patient fractured the right clavicle and underwent placement of a metal plate. His medical history included resection of the right tonsil and soft-palate carcinoma with radical neck dissection and postoperative radiation, which was completed approximately 4 years prior to placement of the metal plate. The patient recently completed 4 to 6 weeks of fluorouracil for shave biopsy–proven actinic keratosis overlying the entire irradiated area.

Physical examination revealed 2 pink friable nodules measuring 1.5 to 2.5 cm in diameter and leaking serous fluid within the irradiated area (Figure 1). The differential diagnosis included pyogenic granuloma, cutaneous recurrent metastasis, and atypical basal cell carcinoma. A skin biopsy specimen showed hemorrhagic ulcerated skin with acute and chronic inflammation and abscess.

To the Editor:

Cutaneous reactions to implantable devices, such as dental implants, intracoronary stents, prosthetic valves, endovascular prostheses, gynecologic devices, and spinal cord stimulator devices, occur with varying frequency and include infectious, hypersensitivity, allergic, and foreign-body reactions. Manifestations have included contact dermatitis; urticarial, vasculitic, and bullous eruptions; extrusion; and granuloma formation.^1,2 Immune complex reactions around implants causing pain, inflammation, and loosening of hardwarealso have been reported.^3,4 Most reported cutaneous reactions typically occur within the first weeks or months after implantation; a reaction rarely presents several years after implantation. We report a cutaneous reaction to an orthopedic appliance almost 10 years after implantation.

A 67-year-old man presented with 2 painful nodules on the right clavicle that were present for several months. The patient denied fever, chills, weight loss, enlarged lymph nodes, or night sweats. Approximately 10 years prior to the appearance of the nodules, the patient fractured the right clavicle and underwent placement of a metal plate. His medical history included resection of the right tonsil and soft-palate carcinoma with radical neck dissection and postoperative radiation, which was completed approximately 4 years prior to placement of the metal plate. The patient recently completed 4 to 6 weeks of fluorouracil for shave biopsy–proven actinic keratosis overlying the entire irradiated area.

Physical examination revealed 2 pink friable nodules measuring 1.5 to 2.5 cm in diameter and leaking serous fluid within the irradiated area (Figure 1). The differential diagnosis included pyogenic granuloma, cutaneous recurrent metastasis, and atypical basal cell carcinoma. A skin biopsy specimen showed hemorrhagic ulcerated skin with acute and chronic inflammation and abscess.

To the Editor:

Cutaneous reactions to implantable devices, such as dental implants, intracoronary stents, prosthetic valves, endovascular prostheses, gynecologic devices, and spinal cord stimulator devices, occur with varying frequency and include infectious, hypersensitivity, allergic, and foreign-body reactions. Manifestations have included contact dermatitis; urticarial, vasculitic, and bullous eruptions; extrusion; and granuloma formation.^1,2 Immune complex reactions around implants causing pain, inflammation, and loosening of hardwarealso have been reported.^3,4 Most reported cutaneous reactions typically occur within the first weeks or months after implantation; a reaction rarely presents several years after implantation. We report a cutaneous reaction to an orthopedic appliance almost 10 years after implantation.

A 67-year-old man presented with 2 painful nodules on the right clavicle that were present for several months. The patient denied fever, chills, weight loss, enlarged lymph nodes, or night sweats. Approximately 10 years prior to the appearance of the nodules, the patient fractured the right clavicle and underwent placement of a metal plate. His medical history included resection of the right tonsil and soft-palate carcinoma with radical neck dissection and postoperative radiation, which was completed approximately 4 years prior to placement of the metal plate. The patient recently completed 4 to 6 weeks of fluorouracil for shave biopsy–proven actinic keratosis overlying the entire irradiated area.

Physical examination revealed 2 pink friable nodules measuring 1.5 to 2.5 cm in diameter and leaking serous fluid within the irradiated area (Figure 1). The differential diagnosis included pyogenic granuloma, cutaneous recurrent metastasis, and atypical basal cell carcinoma. A skin biopsy specimen showed hemorrhagic ulcerated skin with acute and chronic inflammation and abscess.