Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Bone densitometry scans provide useful information that can be used to classify radiographic hip osteoarthritis more objectively than does currently used methods, UK researchers believe.

Based on detecting osteophytes using high-resolution dual energy x-ray absorptiometry (DEXA), the novel grading system they have developed showed an exponential relationship with worsening clinical outcomes such as hip pain, hospital-diagnosed OA, and total hip replacement (THR).

“Given the low radiation doses involved in DEXA, this could open up opportunities for ascertaining OA in larger population-based cohorts than those available for x-rays,” Ben G. Faber, MBBS, BSc, reported at the annual meeting of the British Society for Rheumatology during the best oral abstracts session.

This not only supports further research into OA but also means that it might be possible to use DEXA scans to help screen for hip OA and assess the risk for hip replacement in the future, added Dr. Faber, a Medical Research Council Clinical Research Fellow at the University of Bristol and rheumatology registrar for the North Bristol NHS Trust in England.

Session chair Tonia Vincent, MBBS, PhD, FRCP, a consultant rheumatologist and director of the Centre for Osteoarthritis Pathogenesis at the Kennedy Institute of Rheumatology at the University of Oxford (England), found the relationship between the DEXA findings and Kellgren and Lawrence (KL) grade and clinical outcomes to be “really striking.”

It highlights “a very important structure-symptom relationship, which people in the textbooks say doesn’t exist for osteoarthritis,” Dr. Vincent observed.
 

New scanners, new score

DEXA scans are a mainstay of assessing fracture risk in osteoporosis. Although originally developed for assessing bone mineral density, the newer scanners have such high resolution that they can now show radiographic features such as joint space narrowing (JSN) and the presence of osteophytes.

Both are given equal weighting in existing x-ray grading or scoring systems, which are fairly subjective, Dr. Faber said, but recent research conducted by him and his collaborators has suggested that the presence of osteophytes may be a better indicator of hip pain than JSN.

Using more than 40,000 DEXA scans obtained from the UK Biobank, Dr. Faber and associates developed a semi-automated tool that measured both JSN and osteophytes, giving greater weight to the latter. These patients with DEXA scans in the Biobank had a mean age of 63.7 years. Hip pain was present in 8.1%, hospital-diagnosed OA in 1.3%, and total hip replacement occurred in 0.6%.

The tool the researchers developed automatically calculated the minimum joint space width using a machine-learning-based approach, whereas they manually identified osteophytes at three key locations – the lateral acetabulum, the superior lateral femoral head, and the inferior medial femoral head. However, Dr. Faber said, “we’re now very close to fully automating that part of the process.”

Minimum JSN and osteophyte presence at each location was quantified using a scale of 0 (none) to 3 (greatest) to give a total score out of a possible 12; they then used this score to create five ‘grades’ from 0 (least) to 4 (most).

Applying these new radiographic hip OA grades to the Biobank DEXA scans revealed a strong and increasing association between the presences of osteophytes and the clinical outcomes considered.

For instance, when any osteophytes were detected, the odds ratios (ORs) for having hip pain for more than 3 months, a hospital diagnosis of OA, or THR were a respective 2.05, 4.98, and 6.17.

The presence of inferior or superior femoral osteophytes carried higher ORs for the three outcomes than did acetabular osteophytes, with the greatest ORs seen in patients with osteophytes at all three locations (6.95, 20.53, and 21.79, respectively). By comparison, ORs for JSN were 1.37, 3.48, and 3.91.

There were “strong progressive relationships between each grade of OA and the clinical outcomes,” Dr. Faber said, noting that “the headline figure” was that comparing people with grade 4 with grade 0, the risk for needing THR was 58 times higher. This tallies with what would be expected, Dr. Faber said, since “one would expect to see OA on imaging findings before someone had a total hip replacement.”

What might the future hold?

“One of the strengths of this study is that by using a semi-automated approach, we feel that this is a more objective measure of radiographic hip OA, which hopefully will mean that it’s more reproducible in the future when repeating in other cohorts,” Dr. Faber said.

Asked what he thought the future held, Dr. Faber responded: “A grand vision might be that you’re already doing DEXA scans to look at bone health in individuals, and from those same DEXAs you could get information on radiographic hip OA,” he hypothesized.

“We do this with BMD and we feed that into FRAX [Fracture Risk Assessment Tool] to give someone a fracture risk. Could we do the same for total hip replacement to really identify people are high risk of OA in the future?” he wondered. “Then could we intervene to potentially prevent that ... or increase the duration that they’re healthy before they require the operation? There’s still plenty of work needed to get there.”

Dr. Faber and colleagues work was recently published in Rheumatology.

Dr. Faber had no conflicts of interest to disclose. Dr. Vincent had nothing to declare; her research is funded by Versus Arthritis, the Medical Research Council, the European Research Council, FOREUM (Foundation for Research in Rheumatology), the Dunhill Trust, and the Kennedy Trust for Rheumatology Research.

Bone densitometry scans provide useful information that can be used to classify radiographic hip osteoarthritis more objectively than does currently used methods, UK researchers believe.

Based on detecting osteophytes using high-resolution dual energy x-ray absorptiometry (DEXA), the novel grading system they have developed showed an exponential relationship with worsening clinical outcomes such as hip pain, hospital-diagnosed OA, and total hip replacement (THR).

“Given the low radiation doses involved in DEXA, this could open up opportunities for ascertaining OA in larger population-based cohorts than those available for x-rays,” Ben G. Faber, MBBS, BSc, reported at the annual meeting of the British Society for Rheumatology during the best oral abstracts session.

This not only supports further research into OA but also means that it might be possible to use DEXA scans to help screen for hip OA and assess the risk for hip replacement in the future, added Dr. Faber, a Medical Research Council Clinical Research Fellow at the University of Bristol and rheumatology registrar for the North Bristol NHS Trust in England.

Session chair Tonia Vincent, MBBS, PhD, FRCP, a consultant rheumatologist and director of the Centre for Osteoarthritis Pathogenesis at the Kennedy Institute of Rheumatology at the University of Oxford (England), found the relationship between the DEXA findings and Kellgren and Lawrence (KL) grade and clinical outcomes to be “really striking.”

It highlights “a very important structure-symptom relationship, which people in the textbooks say doesn’t exist for osteoarthritis,” Dr. Vincent observed.
 

New scanners, new score

DEXA scans are a mainstay of assessing fracture risk in osteoporosis. Although originally developed for assessing bone mineral density, the newer scanners have such high resolution that they can now show radiographic features such as joint space narrowing (JSN) and the presence of osteophytes.

Both are given equal weighting in existing x-ray grading or scoring systems, which are fairly subjective, Dr. Faber said, but recent research conducted by him and his collaborators has suggested that the presence of osteophytes may be a better indicator of hip pain than JSN.

Using more than 40,000 DEXA scans obtained from the UK Biobank, Dr. Faber and associates developed a semi-automated tool that measured both JSN and osteophytes, giving greater weight to the latter. These patients with DEXA scans in the Biobank had a mean age of 63.7 years. Hip pain was present in 8.1%, hospital-diagnosed OA in 1.3%, and total hip replacement occurred in 0.6%.

The tool the researchers developed automatically calculated the minimum joint space width using a machine-learning-based approach, whereas they manually identified osteophytes at three key locations – the lateral acetabulum, the superior lateral femoral head, and the inferior medial femoral head. However, Dr. Faber said, “we’re now very close to fully automating that part of the process.”

Minimum JSN and osteophyte presence at each location was quantified using a scale of 0 (none) to 3 (greatest) to give a total score out of a possible 12; they then used this score to create five ‘grades’ from 0 (least) to 4 (most).

Applying these new radiographic hip OA grades to the Biobank DEXA scans revealed a strong and increasing association between the presences of osteophytes and the clinical outcomes considered.

For instance, when any osteophytes were detected, the odds ratios (ORs) for having hip pain for more than 3 months, a hospital diagnosis of OA, or THR were a respective 2.05, 4.98, and 6.17.

The presence of inferior or superior femoral osteophytes carried higher ORs for the three outcomes than did acetabular osteophytes, with the greatest ORs seen in patients with osteophytes at all three locations (6.95, 20.53, and 21.79, respectively). By comparison, ORs for JSN were 1.37, 3.48, and 3.91.

There were “strong progressive relationships between each grade of OA and the clinical outcomes,” Dr. Faber said, noting that “the headline figure” was that comparing people with grade 4 with grade 0, the risk for needing THR was 58 times higher. This tallies with what would be expected, Dr. Faber said, since “one would expect to see OA on imaging findings before someone had a total hip replacement.”

What might the future hold?

“One of the strengths of this study is that by using a semi-automated approach, we feel that this is a more objective measure of radiographic hip OA, which hopefully will mean that it’s more reproducible in the future when repeating in other cohorts,” Dr. Faber said.

Asked what he thought the future held, Dr. Faber responded: “A grand vision might be that you’re already doing DEXA scans to look at bone health in individuals, and from those same DEXAs you could get information on radiographic hip OA,” he hypothesized.

“We do this with BMD and we feed that into FRAX [Fracture Risk Assessment Tool] to give someone a fracture risk. Could we do the same for total hip replacement to really identify people are high risk of OA in the future?” he wondered. “Then could we intervene to potentially prevent that ... or increase the duration that they’re healthy before they require the operation? There’s still plenty of work needed to get there.”

Dr. Faber and colleagues work was recently published in Rheumatology.

Dr. Faber had no conflicts of interest to disclose. Dr. Vincent had nothing to declare; her research is funded by Versus Arthritis, the Medical Research Council, the European Research Council, FOREUM (Foundation for Research in Rheumatology), the Dunhill Trust, and the Kennedy Trust for Rheumatology Research.

Bone densitometry scans provide useful information that can be used to classify radiographic hip osteoarthritis more objectively than does currently used methods, UK researchers believe.

Based on detecting osteophytes using high-resolution dual energy x-ray absorptiometry (DEXA), the novel grading system they have developed showed an exponential relationship with worsening clinical outcomes such as hip pain, hospital-diagnosed OA, and total hip replacement (THR).

“Given the low radiation doses involved in DEXA, this could open up opportunities for ascertaining OA in larger population-based cohorts than those available for x-rays,” Ben G. Faber, MBBS, BSc, reported at the annual meeting of the British Society for Rheumatology during the best oral abstracts session.

This not only supports further research into OA but also means that it might be possible to use DEXA scans to help screen for hip OA and assess the risk for hip replacement in the future, added Dr. Faber, a Medical Research Council Clinical Research Fellow at the University of Bristol and rheumatology registrar for the North Bristol NHS Trust in England.

Session chair Tonia Vincent, MBBS, PhD, FRCP, a consultant rheumatologist and director of the Centre for Osteoarthritis Pathogenesis at the Kennedy Institute of Rheumatology at the University of Oxford (England), found the relationship between the DEXA findings and Kellgren and Lawrence (KL) grade and clinical outcomes to be “really striking.”

It highlights “a very important structure-symptom relationship, which people in the textbooks say doesn’t exist for osteoarthritis,” Dr. Vincent observed.
 

New scanners, new score

DEXA scans are a mainstay of assessing fracture risk in osteoporosis. Although originally developed for assessing bone mineral density, the newer scanners have such high resolution that they can now show radiographic features such as joint space narrowing (JSN) and the presence of osteophytes.

Both are given equal weighting in existing x-ray grading or scoring systems, which are fairly subjective, Dr. Faber said, but recent research conducted by him and his collaborators has suggested that the presence of osteophytes may be a better indicator of hip pain than JSN.

Using more than 40,000 DEXA scans obtained from the UK Biobank, Dr. Faber and associates developed a semi-automated tool that measured both JSN and osteophytes, giving greater weight to the latter. These patients with DEXA scans in the Biobank had a mean age of 63.7 years. Hip pain was present in 8.1%, hospital-diagnosed OA in 1.3%, and total hip replacement occurred in 0.6%.

The tool the researchers developed automatically calculated the minimum joint space width using a machine-learning-based approach, whereas they manually identified osteophytes at three key locations – the lateral acetabulum, the superior lateral femoral head, and the inferior medial femoral head. However, Dr. Faber said, “we’re now very close to fully automating that part of the process.”

Minimum JSN and osteophyte presence at each location was quantified using a scale of 0 (none) to 3 (greatest) to give a total score out of a possible 12; they then used this score to create five ‘grades’ from 0 (least) to 4 (most).

Applying these new radiographic hip OA grades to the Biobank DEXA scans revealed a strong and increasing association between the presences of osteophytes and the clinical outcomes considered.

For instance, when any osteophytes were detected, the odds ratios (ORs) for having hip pain for more than 3 months, a hospital diagnosis of OA, or THR were a respective 2.05, 4.98, and 6.17.

The presence of inferior or superior femoral osteophytes carried higher ORs for the three outcomes than did acetabular osteophytes, with the greatest ORs seen in patients with osteophytes at all three locations (6.95, 20.53, and 21.79, respectively). By comparison, ORs for JSN were 1.37, 3.48, and 3.91.

There were “strong progressive relationships between each grade of OA and the clinical outcomes,” Dr. Faber said, noting that “the headline figure” was that comparing people with grade 4 with grade 0, the risk for needing THR was 58 times higher. This tallies with what would be expected, Dr. Faber said, since “one would expect to see OA on imaging findings before someone had a total hip replacement.”

What might the future hold?

“One of the strengths of this study is that by using a semi-automated approach, we feel that this is a more objective measure of radiographic hip OA, which hopefully will mean that it’s more reproducible in the future when repeating in other cohorts,” Dr. Faber said.

Asked what he thought the future held, Dr. Faber responded: “A grand vision might be that you’re already doing DEXA scans to look at bone health in individuals, and from those same DEXAs you could get information on radiographic hip OA,” he hypothesized.

“We do this with BMD and we feed that into FRAX [Fracture Risk Assessment Tool] to give someone a fracture risk. Could we do the same for total hip replacement to really identify people are high risk of OA in the future?” he wondered. “Then could we intervene to potentially prevent that ... or increase the duration that they’re healthy before they require the operation? There’s still plenty of work needed to get there.”

Dr. Faber and colleagues work was recently published in Rheumatology.

Dr. Faber had no conflicts of interest to disclose. Dr. Vincent had nothing to declare; her research is funded by Versus Arthritis, the Medical Research Council, the European Research Council, FOREUM (Foundation for Research in Rheumatology), the Dunhill Trust, and the Kennedy Trust for Rheumatology Research.

SAN DIEGO – Among nearly 1,200 single-session facial treatments over 6 years that paired injectable hyaluronic acid filler with lasers, none of the documented adverse events that occurred were directly related to spread of filler or laser treatment of the filled area, results from a single-center, retrospective study showed.

“Data on the safety of pairing single-session treatment with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser and fillers are lacking,” Shirin Bajaj, MD, said during a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “Anecdotally, we have found this to be completely safe in our high-volume laser center. We typically do fillers first, followed by laser treatment.”

For the study, Dr. Bajaj, a dermatology fellow at the Laser & Skin Surgery Center of New York, and colleagues retrospectively reviewed the charts of 638 patients who had 1,186 single‐session facial treatments with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser (Fraxel DUAL by Solta) and injectable hyaluronic acid filler from August 2015 to June 2021. Safety over the 6-year period was assessed by the adverse events that occurred within the first 4 weeks. The mean age of patients at the time of treatment was 60 years and 95% were female. Fitzpatrick skin types were type 1 (46.1%), type II (48.1%), type III (5.5%), and type IV (0.3%).

Most patients had 1 single‐session treatment (64.3%); the rest had 2 sessions (17.7%), 3 sessions (8%), or 4-18 sessions (10%). Most (91.2%) were treated with the 1,927-nm thulium laser, while 1.8% were treated with the 1,550-nm erbium laser; the mean total energy delivered was 1.3 kilojoules. A small number of patients (7.0%) received treatment with both lasers.

The most common area treated with filler injections were the cheeks and/or tear troughs (85.6%), followed by the perioral area and/or marionette lines (83.7%), temples (31%), nasolabial folds (25.5%), lips (24%), jawline (23.8%), chin (6.5%), forehead (1.4%), glabella and brows (0.5% each), neck (0.3%), and nose (0.1%). One syringe of filler was used in 58.7% of cases, compared with two syringes in 28.7% of cases, three syringes in 9.9% of cases, and four to six syringes in 2.8% of cases.

Dr. Bajaj reported that of the 1,186 single‐session treatments, no adverse events were recorded that were directly related to spread of filler or laser treatment of the filled area, including product migration, unexpected loss of filler volume, vascular occlusion, acute pain, cutaneous necrosis, blindness, and cutaneous burn. There were no hospital or emergency department transfers or admissions and referrals to ENT specialists or ophthalmologists for additional work‐up.

“This is at a busy cosmetic dermatology and plastic surgery practice,” Dr. Bajaj said. “Additional studies may be needed to further validate our findings.”

The study’s lead author was Jordan V. Wang, MD, who is medical research director at the Laser & Skin Surgery Center of New York.

“At most, this retrospective data confirms what we have known for years to be true: that combination treatments with injectables including fillers are safe,” Catherine M. DiGiorgio, MD, a dermatologist who practices at the Boston Center for Facial Rejuvenation, told this news organization. “This is a small study out of a single office, so that is a limitation. However, many dermatologists have performed Fraxel plus filler treatments in the same session daily for the last 10 years without any issues.”

Dr. DiGiorgio was asked to comment on the results and was not an investigator.

Dr. Bajaj reported having no financial disclosures. Dr. Wang reported that he has received grants and/or research funding from ALASTIN Skincare, Cynosure, Lutronic, Novoxel, Sofwave, Solta Medical, Blossom Innovations, Allergan, Accure Acne Inc., and Soliton. Dr. DiGiorgio reported having no relevant disclosures.

SAN DIEGO – Among nearly 1,200 single-session facial treatments over 6 years that paired injectable hyaluronic acid filler with lasers, none of the documented adverse events that occurred were directly related to spread of filler or laser treatment of the filled area, results from a single-center, retrospective study showed.

“Data on the safety of pairing single-session treatment with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser and fillers are lacking,” Shirin Bajaj, MD, said during a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “Anecdotally, we have found this to be completely safe in our high-volume laser center. We typically do fillers first, followed by laser treatment.”

For the study, Dr. Bajaj, a dermatology fellow at the Laser & Skin Surgery Center of New York, and colleagues retrospectively reviewed the charts of 638 patients who had 1,186 single‐session facial treatments with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser (Fraxel DUAL by Solta) and injectable hyaluronic acid filler from August 2015 to June 2021. Safety over the 6-year period was assessed by the adverse events that occurred within the first 4 weeks. The mean age of patients at the time of treatment was 60 years and 95% were female. Fitzpatrick skin types were type 1 (46.1%), type II (48.1%), type III (5.5%), and type IV (0.3%).

Most patients had 1 single‐session treatment (64.3%); the rest had 2 sessions (17.7%), 3 sessions (8%), or 4-18 sessions (10%). Most (91.2%) were treated with the 1,927-nm thulium laser, while 1.8% were treated with the 1,550-nm erbium laser; the mean total energy delivered was 1.3 kilojoules. A small number of patients (7.0%) received treatment with both lasers.

The most common area treated with filler injections were the cheeks and/or tear troughs (85.6%), followed by the perioral area and/or marionette lines (83.7%), temples (31%), nasolabial folds (25.5%), lips (24%), jawline (23.8%), chin (6.5%), forehead (1.4%), glabella and brows (0.5% each), neck (0.3%), and nose (0.1%). One syringe of filler was used in 58.7% of cases, compared with two syringes in 28.7% of cases, three syringes in 9.9% of cases, and four to six syringes in 2.8% of cases.

Dr. Bajaj reported that of the 1,186 single‐session treatments, no adverse events were recorded that were directly related to spread of filler or laser treatment of the filled area, including product migration, unexpected loss of filler volume, vascular occlusion, acute pain, cutaneous necrosis, blindness, and cutaneous burn. There were no hospital or emergency department transfers or admissions and referrals to ENT specialists or ophthalmologists for additional work‐up.

“This is at a busy cosmetic dermatology and plastic surgery practice,” Dr. Bajaj said. “Additional studies may be needed to further validate our findings.”

The study’s lead author was Jordan V. Wang, MD, who is medical research director at the Laser & Skin Surgery Center of New York.

“At most, this retrospective data confirms what we have known for years to be true: that combination treatments with injectables including fillers are safe,” Catherine M. DiGiorgio, MD, a dermatologist who practices at the Boston Center for Facial Rejuvenation, told this news organization. “This is a small study out of a single office, so that is a limitation. However, many dermatologists have performed Fraxel plus filler treatments in the same session daily for the last 10 years without any issues.”

Dr. DiGiorgio was asked to comment on the results and was not an investigator.

Dr. Bajaj reported having no financial disclosures. Dr. Wang reported that he has received grants and/or research funding from ALASTIN Skincare, Cynosure, Lutronic, Novoxel, Sofwave, Solta Medical, Blossom Innovations, Allergan, Accure Acne Inc., and Soliton. Dr. DiGiorgio reported having no relevant disclosures.

SAN DIEGO – Among nearly 1,200 single-session facial treatments over 6 years that paired injectable hyaluronic acid filler with lasers, none of the documented adverse events that occurred were directly related to spread of filler or laser treatment of the filled area, results from a single-center, retrospective study showed.

“Data on the safety of pairing single-session treatment with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser and fillers are lacking,” Shirin Bajaj, MD, said during a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “Anecdotally, we have found this to be completely safe in our high-volume laser center. We typically do fillers first, followed by laser treatment.”

For the study, Dr. Bajaj, a dermatology fellow at the Laser & Skin Surgery Center of New York, and colleagues retrospectively reviewed the charts of 638 patients who had 1,186 single‐session facial treatments with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser (Fraxel DUAL by Solta) and injectable hyaluronic acid filler from August 2015 to June 2021. Safety over the 6-year period was assessed by the adverse events that occurred within the first 4 weeks. The mean age of patients at the time of treatment was 60 years and 95% were female. Fitzpatrick skin types were type 1 (46.1%), type II (48.1%), type III (5.5%), and type IV (0.3%).

Most patients had 1 single‐session treatment (64.3%); the rest had 2 sessions (17.7%), 3 sessions (8%), or 4-18 sessions (10%). Most (91.2%) were treated with the 1,927-nm thulium laser, while 1.8% were treated with the 1,550-nm erbium laser; the mean total energy delivered was 1.3 kilojoules. A small number of patients (7.0%) received treatment with both lasers.

The most common area treated with filler injections were the cheeks and/or tear troughs (85.6%), followed by the perioral area and/or marionette lines (83.7%), temples (31%), nasolabial folds (25.5%), lips (24%), jawline (23.8%), chin (6.5%), forehead (1.4%), glabella and brows (0.5% each), neck (0.3%), and nose (0.1%). One syringe of filler was used in 58.7% of cases, compared with two syringes in 28.7% of cases, three syringes in 9.9% of cases, and four to six syringes in 2.8% of cases.

Dr. Bajaj reported that of the 1,186 single‐session treatments, no adverse events were recorded that were directly related to spread of filler or laser treatment of the filled area, including product migration, unexpected loss of filler volume, vascular occlusion, acute pain, cutaneous necrosis, blindness, and cutaneous burn. There were no hospital or emergency department transfers or admissions and referrals to ENT specialists or ophthalmologists for additional work‐up.

“This is at a busy cosmetic dermatology and plastic surgery practice,” Dr. Bajaj said. “Additional studies may be needed to further validate our findings.”

The study’s lead author was Jordan V. Wang, MD, who is medical research director at the Laser & Skin Surgery Center of New York.

“At most, this retrospective data confirms what we have known for years to be true: that combination treatments with injectables including fillers are safe,” Catherine M. DiGiorgio, MD, a dermatologist who practices at the Boston Center for Facial Rejuvenation, told this news organization. “This is a small study out of a single office, so that is a limitation. However, many dermatologists have performed Fraxel plus filler treatments in the same session daily for the last 10 years without any issues.”

Dr. DiGiorgio was asked to comment on the results and was not an investigator.

Dr. Bajaj reported having no financial disclosures. Dr. Wang reported that he has received grants and/or research funding from ALASTIN Skincare, Cynosure, Lutronic, Novoxel, Sofwave, Solta Medical, Blossom Innovations, Allergan, Accure Acne Inc., and Soliton. Dr. DiGiorgio reported having no relevant disclosures.

SAN DIEGO – Combining radiofrequency and targeted ultrasound demonstrated significantly better improvements in the quality of wrinkles and skin laxity in the facial region compared with radiofrequency alone at 3 months, results from a multicenter blinded trial showed.

“We’ve done a lot of work with radiofrequency, and we’ve done a lot of work with ultrasound,” Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “The question becomes, is there truly a difference if we’re combining them together?”

To find out, Dr. Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.

In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Dr. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.

Dr. Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)

3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.

“I think this is going to be one more very useful, versatile tool in our toolbox,” Dr. Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. “It’s something that’s effective, painless, and the treatment time is very short – approximately 10 minutes per side. It’s extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain.”

Moreover, he added, many patients in the trial have asked to have further treatments “and are on a waiting list for when the product launches.”

He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as “unexpected and interesting.”

Dr. Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. “If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts,” he explained.

“I can’t say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you’re going to see more change with the fibroblast activity leading to collagenesis and elastogenesis.”

Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. “I’d also be cautious about using it in people with melasma as the device’s mechanism is based on heat,” since current scientific evidence shows that heat can worsen melasma, he added. “For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma.”

“We know that skin tightening is a difficult task for a nonablative, nonsurgical device,” said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.

“The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven’t yet had a home run. As a consequence, there’s a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let’s not overlook the idea of having multiple devices at the same time. The nice thing they’ve shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime.”

BTL Aesthetics, the manufacturer, loaned the device used in the trial. Dr. Chilukuri reported having no other financial conflicts for this study. Dr. Alam reported having no disclosures.

SAN DIEGO – Combining radiofrequency and targeted ultrasound demonstrated significantly better improvements in the quality of wrinkles and skin laxity in the facial region compared with radiofrequency alone at 3 months, results from a multicenter blinded trial showed.

“We’ve done a lot of work with radiofrequency, and we’ve done a lot of work with ultrasound,” Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “The question becomes, is there truly a difference if we’re combining them together?”

To find out, Dr. Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.

In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Dr. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.

Dr. Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)

3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.

“I think this is going to be one more very useful, versatile tool in our toolbox,” Dr. Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. “It’s something that’s effective, painless, and the treatment time is very short – approximately 10 minutes per side. It’s extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain.”

Moreover, he added, many patients in the trial have asked to have further treatments “and are on a waiting list for when the product launches.”

He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as “unexpected and interesting.”

Dr. Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. “If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts,” he explained.

“I can’t say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you’re going to see more change with the fibroblast activity leading to collagenesis and elastogenesis.”

Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. “I’d also be cautious about using it in people with melasma as the device’s mechanism is based on heat,” since current scientific evidence shows that heat can worsen melasma, he added. “For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma.”

“We know that skin tightening is a difficult task for a nonablative, nonsurgical device,” said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.

“The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven’t yet had a home run. As a consequence, there’s a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let’s not overlook the idea of having multiple devices at the same time. The nice thing they’ve shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime.”

BTL Aesthetics, the manufacturer, loaned the device used in the trial. Dr. Chilukuri reported having no other financial conflicts for this study. Dr. Alam reported having no disclosures.

SAN DIEGO – Combining radiofrequency and targeted ultrasound demonstrated significantly better improvements in the quality of wrinkles and skin laxity in the facial region compared with radiofrequency alone at 3 months, results from a multicenter blinded trial showed.

“We’ve done a lot of work with radiofrequency, and we’ve done a lot of work with ultrasound,” Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “The question becomes, is there truly a difference if we’re combining them together?”

To find out, Dr. Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.

In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Dr. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.

Dr. Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)

3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.

“I think this is going to be one more very useful, versatile tool in our toolbox,” Dr. Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. “It’s something that’s effective, painless, and the treatment time is very short – approximately 10 minutes per side. It’s extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain.”

Moreover, he added, many patients in the trial have asked to have further treatments “and are on a waiting list for when the product launches.”

He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as “unexpected and interesting.”

Dr. Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. “If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts,” he explained.

“I can’t say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you’re going to see more change with the fibroblast activity leading to collagenesis and elastogenesis.”

Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. “I’d also be cautious about using it in people with melasma as the device’s mechanism is based on heat,” since current scientific evidence shows that heat can worsen melasma, he added. “For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma.”

“We know that skin tightening is a difficult task for a nonablative, nonsurgical device,” said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.

“The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven’t yet had a home run. As a consequence, there’s a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let’s not overlook the idea of having multiple devices at the same time. The nice thing they’ve shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime.”

BTL Aesthetics, the manufacturer, loaned the device used in the trial. Dr. Chilukuri reported having no other financial conflicts for this study. Dr. Alam reported having no disclosures.

A new type of genetic test known as a polygenic risk score could change the way clinicians detect and treat chronic illnesses. But to be widely used, genomic findings in large populations first need to be translated into valid clinical tests for individual patients. Then physicians need meaningful interpretations of test data to help make clinical decisions about patient care.

In a study published in Nature Medicine, researchers report details of how they set up a genetic assay for six common diseases and developed explanatory reports to help bridge the gap between science and clinical care.

The assay and reports were created for the GenoVA study, a clinical trial that aims to determine whether polygenic risk scores (PRSs), also known as polygenic scores (PGSs), could be used effectively in a primary care setting. The randomized trial will enroll 1,000 patients at the Veterans Affairs Boston Healthcare System and will follow them for 2 years.

The authors report early data from the new laboratory test. For the 227 participants enrolled so far, 11% had a high risk for atrial fibrillation, 7% were at risk for coronary artery disease, 8% for type 2 diabetes, 6% for colorectal cancer, 15% of men had an increased prostate cancer risk, and 13% of women were at increased risk for breast cancer.

Polygenic scores are promising for informing screening and treatment decisions, with the goal of preventing chronic disease. Jason Vassy, MD, of Brigham and Women’s Hospital and VA Boston, says, “It is important to think of PRS as one risk factor for disease, not a diagnostic test or an indication that an individual will certainly develop the disease.”

He continues, “Most diseases have complex, multifactorial etiologies, and a high PRS is just one piece of the puzzle. PRSs do not replace the traditional risk factors we usually think about in clinical medicine, such as diet and exercise to prevent type 2 diabetes and smoking cessation to lower cardiovascular disease risk.”

Currently, clinical genetic testing is typically performed when a patient is suspected of having a specific disease or a family history of a condition, such as sickle cell disease or breast cancer. Tests for these types of conditions are often monogenic, detecting only select mutations.

PRS tests have the potential to inform clinical decisions years before patients become symptomatic. The PRS testing in this study combines large quantities of genetic information to assess a patient’s risk for multiple conditions. The risk for common chronic conditions can involve hundreds to millions of small genetic variations. Alone, these variations have minimal impact on a person’s risk for disease, but together they can lead to an increased risk for specific conditions.

Certain PRS tests are currently available from direct-to-consumer laboratories, in oncology, and through some clinical trials, but they’re not commonly used in general practice.

Dr. Vassy and colleagues developed and validated PRSs for atrial fibrillation, coronary artery disease, type 2 diabetes, breast cancer, colorectal cancer, and prostate cancer at the Mass General Brigham Laboratory for Molecular Medicine.

The team calculated the final PRS on the basis of individual patient genotyping combined with statistical population models.

In the GenoVA study, adults aged 50-70 years who have no previous history of disease provide saliva or blood for PRS testing at the Boston VA. Participants are stratified by risk result and are randomly assigned to receive test results either immediately or after 24 months.

Enrollees are then followed for 2 years to observe how they and their primary care providers use risk score information and whether any preventive measures or other clinical tests are employed. Guidelines are provided to patients and clinicians throughout the study, along with genetic counseling. Ultimately, the study seeks to determine whether PRS implementation improves health outcomes.

Study participants are from diverse backgrounds: 52% of the first 227 patients report non-White, non-Hispanic ethnicity. To adjust for the fact that most genomic research to date has been based on European populations, researchers used statistical methods to calculate scores across racial groups.
 

Is PRS testing the future of chronic disease prevention?

Genome wide association studies (GWASs) from more inclusive datasets are needed to improve the relevance of PRS across ancestry groups, the authors write.

Dr. Vassy points out that “the risk estimates from GWAS are the underpinnings of the polygenic scores, so a score is only as valid as its original.” Fortunately, he adds, “advances are occurring on multiple fronts, and this will be key to promoting the equitable implementation of polygenic scores. Larger, more diverse cohorts are being recruited for GWAS studies, and more sophisticated, trans-ancestry statistical GWAS methods are being developed to analyze these more diverse data.”

In England, researchers are considering the benefits of using polygenic scores in National Health Service checks for cardiovascular disease, a well-studied area of genetic risk. The new article and the English effort draw from the PGS Catalogue, an open database built by Samuel Lambert, of the University of Cambridge Department of Public Health and Primary Care, and his colleagues to provide scores and methods that can be reused and adapted for clinical use.

He says he’d recommend PRS with confidence to his family members – in particular, certain in-depth cancer assays – “provided [the results] would be interpreted in collaboration with a health care professional who understands genetics (for example, a genetic counselor) with carefully vetted information on the validity and actionability of the test result.”

Mr. Lambert feels it’s important to understand that PRS testing isn’t deterministic. “The risk information is inherently probabilistic and relative (for example, you have a four times higher risk than the average person, but if the disease prevalence is 0.5%, this is a small absolute difference),” he says.

“The PRS also explains a fraction of the variability of risk in the population and thus shouldn’t be used alone but in combination with other established risk factors and tools to predict future risk when they exist,” Mr. Lambert says.

“And thirdly, most current PRS are less accurate in those of non-European ancestry due to a lack of ancestral diversity in the cohorts and datasets that have been used to develop these PRS; special attention must be paid to make sure that the PRS results are valid for the individual,” he adds.

Funding for the study was provided by the NIH National Human Genome Research Institute and NIH, the American Heart Association, the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and Massachusetts General Hospital. Dr. Vassy is an employee of the U.S. Department of Veterans Affairs; the views expressed do not represent those of the VA or the U.S. government. Mr. Lambert is an employee of Cambridge-Baker Systems Genomics Initiative, Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care.

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

A new type of genetic test known as a polygenic risk score could change the way clinicians detect and treat chronic illnesses. But to be widely used, genomic findings in large populations first need to be translated into valid clinical tests for individual patients. Then physicians need meaningful interpretations of test data to help make clinical decisions about patient care.

In a study published in Nature Medicine, researchers report details of how they set up a genetic assay for six common diseases and developed explanatory reports to help bridge the gap between science and clinical care.

The assay and reports were created for the GenoVA study, a clinical trial that aims to determine whether polygenic risk scores (PRSs), also known as polygenic scores (PGSs), could be used effectively in a primary care setting. The randomized trial will enroll 1,000 patients at the Veterans Affairs Boston Healthcare System and will follow them for 2 years.

The authors report early data from the new laboratory test. For the 227 participants enrolled so far, 11% had a high risk for atrial fibrillation, 7% were at risk for coronary artery disease, 8% for type 2 diabetes, 6% for colorectal cancer, 15% of men had an increased prostate cancer risk, and 13% of women were at increased risk for breast cancer.

Polygenic scores are promising for informing screening and treatment decisions, with the goal of preventing chronic disease. Jason Vassy, MD, of Brigham and Women’s Hospital and VA Boston, says, “It is important to think of PRS as one risk factor for disease, not a diagnostic test or an indication that an individual will certainly develop the disease.”

He continues, “Most diseases have complex, multifactorial etiologies, and a high PRS is just one piece of the puzzle. PRSs do not replace the traditional risk factors we usually think about in clinical medicine, such as diet and exercise to prevent type 2 diabetes and smoking cessation to lower cardiovascular disease risk.”

Currently, clinical genetic testing is typically performed when a patient is suspected of having a specific disease or a family history of a condition, such as sickle cell disease or breast cancer. Tests for these types of conditions are often monogenic, detecting only select mutations.

PRS tests have the potential to inform clinical decisions years before patients become symptomatic. The PRS testing in this study combines large quantities of genetic information to assess a patient’s risk for multiple conditions. The risk for common chronic conditions can involve hundreds to millions of small genetic variations. Alone, these variations have minimal impact on a person’s risk for disease, but together they can lead to an increased risk for specific conditions.

Certain PRS tests are currently available from direct-to-consumer laboratories, in oncology, and through some clinical trials, but they’re not commonly used in general practice.

Dr. Vassy and colleagues developed and validated PRSs for atrial fibrillation, coronary artery disease, type 2 diabetes, breast cancer, colorectal cancer, and prostate cancer at the Mass General Brigham Laboratory for Molecular Medicine.

The team calculated the final PRS on the basis of individual patient genotyping combined with statistical population models.

In the GenoVA study, adults aged 50-70 years who have no previous history of disease provide saliva or blood for PRS testing at the Boston VA. Participants are stratified by risk result and are randomly assigned to receive test results either immediately or after 24 months.

Enrollees are then followed for 2 years to observe how they and their primary care providers use risk score information and whether any preventive measures or other clinical tests are employed. Guidelines are provided to patients and clinicians throughout the study, along with genetic counseling. Ultimately, the study seeks to determine whether PRS implementation improves health outcomes.

Study participants are from diverse backgrounds: 52% of the first 227 patients report non-White, non-Hispanic ethnicity. To adjust for the fact that most genomic research to date has been based on European populations, researchers used statistical methods to calculate scores across racial groups.
 

Is PRS testing the future of chronic disease prevention?

Genome wide association studies (GWASs) from more inclusive datasets are needed to improve the relevance of PRS across ancestry groups, the authors write.

Dr. Vassy points out that “the risk estimates from GWAS are the underpinnings of the polygenic scores, so a score is only as valid as its original.” Fortunately, he adds, “advances are occurring on multiple fronts, and this will be key to promoting the equitable implementation of polygenic scores. Larger, more diverse cohorts are being recruited for GWAS studies, and more sophisticated, trans-ancestry statistical GWAS methods are being developed to analyze these more diverse data.”

In England, researchers are considering the benefits of using polygenic scores in National Health Service checks for cardiovascular disease, a well-studied area of genetic risk. The new article and the English effort draw from the PGS Catalogue, an open database built by Samuel Lambert, of the University of Cambridge Department of Public Health and Primary Care, and his colleagues to provide scores and methods that can be reused and adapted for clinical use.

He says he’d recommend PRS with confidence to his family members – in particular, certain in-depth cancer assays – “provided [the results] would be interpreted in collaboration with a health care professional who understands genetics (for example, a genetic counselor) with carefully vetted information on the validity and actionability of the test result.”

Mr. Lambert feels it’s important to understand that PRS testing isn’t deterministic. “The risk information is inherently probabilistic and relative (for example, you have a four times higher risk than the average person, but if the disease prevalence is 0.5%, this is a small absolute difference),” he says.

“The PRS also explains a fraction of the variability of risk in the population and thus shouldn’t be used alone but in combination with other established risk factors and tools to predict future risk when they exist,” Mr. Lambert says.

“And thirdly, most current PRS are less accurate in those of non-European ancestry due to a lack of ancestral diversity in the cohorts and datasets that have been used to develop these PRS; special attention must be paid to make sure that the PRS results are valid for the individual,” he adds.

Funding for the study was provided by the NIH National Human Genome Research Institute and NIH, the American Heart Association, the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and Massachusetts General Hospital. Dr. Vassy is an employee of the U.S. Department of Veterans Affairs; the views expressed do not represent those of the VA or the U.S. government. Mr. Lambert is an employee of Cambridge-Baker Systems Genomics Initiative, Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care.

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

A new type of genetic test known as a polygenic risk score could change the way clinicians detect and treat chronic illnesses. But to be widely used, genomic findings in large populations first need to be translated into valid clinical tests for individual patients. Then physicians need meaningful interpretations of test data to help make clinical decisions about patient care.

In a study published in Nature Medicine, researchers report details of how they set up a genetic assay for six common diseases and developed explanatory reports to help bridge the gap between science and clinical care.

The assay and reports were created for the GenoVA study, a clinical trial that aims to determine whether polygenic risk scores (PRSs), also known as polygenic scores (PGSs), could be used effectively in a primary care setting. The randomized trial will enroll 1,000 patients at the Veterans Affairs Boston Healthcare System and will follow them for 2 years.

The authors report early data from the new laboratory test. For the 227 participants enrolled so far, 11% had a high risk for atrial fibrillation, 7% were at risk for coronary artery disease, 8% for type 2 diabetes, 6% for colorectal cancer, 15% of men had an increased prostate cancer risk, and 13% of women were at increased risk for breast cancer.

Polygenic scores are promising for informing screening and treatment decisions, with the goal of preventing chronic disease. Jason Vassy, MD, of Brigham and Women’s Hospital and VA Boston, says, “It is important to think of PRS as one risk factor for disease, not a diagnostic test or an indication that an individual will certainly develop the disease.”

He continues, “Most diseases have complex, multifactorial etiologies, and a high PRS is just one piece of the puzzle. PRSs do not replace the traditional risk factors we usually think about in clinical medicine, such as diet and exercise to prevent type 2 diabetes and smoking cessation to lower cardiovascular disease risk.”

Currently, clinical genetic testing is typically performed when a patient is suspected of having a specific disease or a family history of a condition, such as sickle cell disease or breast cancer. Tests for these types of conditions are often monogenic, detecting only select mutations.

PRS tests have the potential to inform clinical decisions years before patients become symptomatic. The PRS testing in this study combines large quantities of genetic information to assess a patient’s risk for multiple conditions. The risk for common chronic conditions can involve hundreds to millions of small genetic variations. Alone, these variations have minimal impact on a person’s risk for disease, but together they can lead to an increased risk for specific conditions.

Certain PRS tests are currently available from direct-to-consumer laboratories, in oncology, and through some clinical trials, but they’re not commonly used in general practice.

Dr. Vassy and colleagues developed and validated PRSs for atrial fibrillation, coronary artery disease, type 2 diabetes, breast cancer, colorectal cancer, and prostate cancer at the Mass General Brigham Laboratory for Molecular Medicine.

The team calculated the final PRS on the basis of individual patient genotyping combined with statistical population models.

In the GenoVA study, adults aged 50-70 years who have no previous history of disease provide saliva or blood for PRS testing at the Boston VA. Participants are stratified by risk result and are randomly assigned to receive test results either immediately or after 24 months.

Enrollees are then followed for 2 years to observe how they and their primary care providers use risk score information and whether any preventive measures or other clinical tests are employed. Guidelines are provided to patients and clinicians throughout the study, along with genetic counseling. Ultimately, the study seeks to determine whether PRS implementation improves health outcomes.

Study participants are from diverse backgrounds: 52% of the first 227 patients report non-White, non-Hispanic ethnicity. To adjust for the fact that most genomic research to date has been based on European populations, researchers used statistical methods to calculate scores across racial groups.
 

Is PRS testing the future of chronic disease prevention?

Genome wide association studies (GWASs) from more inclusive datasets are needed to improve the relevance of PRS across ancestry groups, the authors write.

Dr. Vassy points out that “the risk estimates from GWAS are the underpinnings of the polygenic scores, so a score is only as valid as its original.” Fortunately, he adds, “advances are occurring on multiple fronts, and this will be key to promoting the equitable implementation of polygenic scores. Larger, more diverse cohorts are being recruited for GWAS studies, and more sophisticated, trans-ancestry statistical GWAS methods are being developed to analyze these more diverse data.”

In England, researchers are considering the benefits of using polygenic scores in National Health Service checks for cardiovascular disease, a well-studied area of genetic risk. The new article and the English effort draw from the PGS Catalogue, an open database built by Samuel Lambert, of the University of Cambridge Department of Public Health and Primary Care, and his colleagues to provide scores and methods that can be reused and adapted for clinical use.

He says he’d recommend PRS with confidence to his family members – in particular, certain in-depth cancer assays – “provided [the results] would be interpreted in collaboration with a health care professional who understands genetics (for example, a genetic counselor) with carefully vetted information on the validity and actionability of the test result.”

Mr. Lambert feels it’s important to understand that PRS testing isn’t deterministic. “The risk information is inherently probabilistic and relative (for example, you have a four times higher risk than the average person, but if the disease prevalence is 0.5%, this is a small absolute difference),” he says.

“The PRS also explains a fraction of the variability of risk in the population and thus shouldn’t be used alone but in combination with other established risk factors and tools to predict future risk when they exist,” Mr. Lambert says.

“And thirdly, most current PRS are less accurate in those of non-European ancestry due to a lack of ancestral diversity in the cohorts and datasets that have been used to develop these PRS; special attention must be paid to make sure that the PRS results are valid for the individual,” he adds.

Funding for the study was provided by the NIH National Human Genome Research Institute and NIH, the American Heart Association, the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and Massachusetts General Hospital. Dr. Vassy is an employee of the U.S. Department of Veterans Affairs; the views expressed do not represent those of the VA or the U.S. government. Mr. Lambert is an employee of Cambridge-Baker Systems Genomics Initiative, Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care.

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

Impaired vision in older adults is an underrecognized and modifiable dementia risk factor, new research suggests.

Investigators analyzed estimated population attributable fractions (PAFs) associated with dementia in more than 16,000 older adults. A PAF represents the number of dementia cases that could be prevented if a given risk factor were eliminated.

Results showed the PAF of vision impairment was 1.8%, suggesting that healthy vision had the potential to prevent more than 100,000 cases of dementia in the United States.

“Vision impairment and blindness disproportionately impact older adults, yet vision impairment is often preventable or even correctable,” study investigator Joshua Ehrlich MD, assistant professor of ophthalmology and visual sciences, University of Michigan, Ann Arbor, said in an interview.

Poor vision affects not only how individuals see the world, but also their systemic health and well-being, Dr. Ehrlich said.

“Accordingly, ensuring that older adults receive appropriate eye care is vital to promoting health, independence, and optimal aging,” he added.

The findings were published online in JAMA Neurology.
 

A surprising omission

There is an “urgent need to identify modifiable risk factors for dementia that can be targeted with interventions to slow cognitive decline and prevent dementia,” the investigators wrote.

In 2020, the Lancet Commission report on dementia prevention, intervention, and care proposed a life-course model of 12 potentially modifiable dementia risk factors. This included lower educational level, hearing loss, traumatic brain injury, hypertension, excessive alcohol consumption, obesity, smoking, depression, social isolation, physical inactivity, diabetes, and air pollution.

Together, these factors are associated with about 40% of dementia cases worldwide, the report notes.

Vision impairment was not included in this model, “despite considerable evidence that it is associated with an elevated risk of incident dementia and that it may operate through the same pathways as hearing loss,” the current researchers wrote.

“We have known for some time that vision impairment is a risk factor for dementia [and] we also know that a very large fraction of vision impairment, possibly in excess of 80%, is avoidable or has simply yet to be addressed,” Dr. Ehrlich said.

He and his colleagues found it “surprising that vision impairment had been ignored in key models of modifiable dementia risk factors that are used to shape health policy and resource allocation.” They set out to demonstrate that, “in fact, vision impairment is just as influential as a number of other long accepted modifiable dementia risk factors.”

The investigators assessed data from the Health and Retirement Study (HRS), a panel study that surveys more than 20,000 U.S. adults aged 50 years or older every 2 years.

The investigators applied the same methods used by the Lancet Commission to the HRS dataset and added vision impairment to the Lancet life-course model. Air pollution was excluded in their model “because those data were not readily available in the HRS,” the researchers wrote.

They noted the PAF is “based on the population prevalence and relative risk of dementia for each risk factor” and is “weighted, based on a principal components analysis, to account for communality (clustering of risk factors).”
 

A missed prevention opportunity

The sample included 16,690 participants (54% were women, 51.5% were at least age 65, 80.2% were White, 10.6% were Black, 9.2% were other).

In total, the 12 potentially modifiable risk factors used in the researchers’ model were associated with an estimated 62.4% of dementia cases in the United States, with hypertension as the most prevalent risk factor with the highest weighted PAF.
 

A new focus for prevention

Commenting for this article, Suzann Pershing, MD, associate professor of ophthalmology, Stanford (Calif.) University, called the study “particularly important because, despite growing recognition of its importance in relation to cognition, visual impairment is often an underrecognized risk factor.”

The current research “builds on increasingly robust medical literature linking visual impairment and dementia, applying analogous methods to those used for the life course model recently presented by the Lancet Commission to evaluate potentially modifiable dementia risk factors,” said Dr. Pershing, who was not involved with the study.

The investigators “make a compelling argument for inclusion of visual impairment as one of the potentially modifiable risk factors; practicing clinicians and health care systems may consider screening and targeted therapies to address visual impairment, with a goal of population health and contributing to a reduction in future dementia disease burden,” she added.

In an accompanying editorial), Jennifer Deal, PhD, department of epidemiology and Cochlear Center for Hearing and Public Health, Baltimore, and Julio Rojas, MD, PhD, Memory and Aging Center, department of neurology, Weill Institute for Neurosciences, University of California, San Francisco, call the findings “an important reminder that dementia is a social problem in which potentially treatable risk factors, including visual impairment, are highly prevalent in disadvantaged populations.”

The editorialists noted that 90% of cases of vision impairment are “preventable or have yet to be treated. The two “highly cost-effective interventions” of eyeglasses and/or cataract surgery “remain underused both in the U.S. and globally, especially in disadvantaged communities,” they wrote.

They added that more research is needed to “test the effectiveness of interventions to preserve cognitive health by promoting healthy vision.”

The study was supported by grants from the National Institute on Aging, the National Institutes of Health, and Research to Prevent Blindness. The investigators reported no relevant financial relationships. Dr. Deal reported having received grants from the National Institute on Aging. Dr. Rojas reported serving as site principal investigator on clinical trials for Eli Lilly and Eisai and receiving grants from the National Institute on Aging. Dr. Pershing is a consultant for Acumen, and Verana Health (as DigiSight Technologies).

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

Impaired vision in older adults is an underrecognized and modifiable dementia risk factor, new research suggests.

Investigators analyzed estimated population attributable fractions (PAFs) associated with dementia in more than 16,000 older adults. A PAF represents the number of dementia cases that could be prevented if a given risk factor were eliminated.

Results showed the PAF of vision impairment was 1.8%, suggesting that healthy vision had the potential to prevent more than 100,000 cases of dementia in the United States.

“Vision impairment and blindness disproportionately impact older adults, yet vision impairment is often preventable or even correctable,” study investigator Joshua Ehrlich MD, assistant professor of ophthalmology and visual sciences, University of Michigan, Ann Arbor, said in an interview.

Poor vision affects not only how individuals see the world, but also their systemic health and well-being, Dr. Ehrlich said.

“Accordingly, ensuring that older adults receive appropriate eye care is vital to promoting health, independence, and optimal aging,” he added.

The findings were published online in JAMA Neurology.
 

A surprising omission

There is an “urgent need to identify modifiable risk factors for dementia that can be targeted with interventions to slow cognitive decline and prevent dementia,” the investigators wrote.

In 2020, the Lancet Commission report on dementia prevention, intervention, and care proposed a life-course model of 12 potentially modifiable dementia risk factors. This included lower educational level, hearing loss, traumatic brain injury, hypertension, excessive alcohol consumption, obesity, smoking, depression, social isolation, physical inactivity, diabetes, and air pollution.

Together, these factors are associated with about 40% of dementia cases worldwide, the report notes.

Vision impairment was not included in this model, “despite considerable evidence that it is associated with an elevated risk of incident dementia and that it may operate through the same pathways as hearing loss,” the current researchers wrote.

“We have known for some time that vision impairment is a risk factor for dementia [and] we also know that a very large fraction of vision impairment, possibly in excess of 80%, is avoidable or has simply yet to be addressed,” Dr. Ehrlich said.

He and his colleagues found it “surprising that vision impairment had been ignored in key models of modifiable dementia risk factors that are used to shape health policy and resource allocation.” They set out to demonstrate that, “in fact, vision impairment is just as influential as a number of other long accepted modifiable dementia risk factors.”

The investigators assessed data from the Health and Retirement Study (HRS), a panel study that surveys more than 20,000 U.S. adults aged 50 years or older every 2 years.

The investigators applied the same methods used by the Lancet Commission to the HRS dataset and added vision impairment to the Lancet life-course model. Air pollution was excluded in their model “because those data were not readily available in the HRS,” the researchers wrote.

They noted the PAF is “based on the population prevalence and relative risk of dementia for each risk factor” and is “weighted, based on a principal components analysis, to account for communality (clustering of risk factors).”
 

A missed prevention opportunity

The sample included 16,690 participants (54% were women, 51.5% were at least age 65, 80.2% were White, 10.6% were Black, 9.2% were other).

In total, the 12 potentially modifiable risk factors used in the researchers’ model were associated with an estimated 62.4% of dementia cases in the United States, with hypertension as the most prevalent risk factor with the highest weighted PAF.
 

A new focus for prevention

Commenting for this article, Suzann Pershing, MD, associate professor of ophthalmology, Stanford (Calif.) University, called the study “particularly important because, despite growing recognition of its importance in relation to cognition, visual impairment is often an underrecognized risk factor.”

The current research “builds on increasingly robust medical literature linking visual impairment and dementia, applying analogous methods to those used for the life course model recently presented by the Lancet Commission to evaluate potentially modifiable dementia risk factors,” said Dr. Pershing, who was not involved with the study.

The investigators “make a compelling argument for inclusion of visual impairment as one of the potentially modifiable risk factors; practicing clinicians and health care systems may consider screening and targeted therapies to address visual impairment, with a goal of population health and contributing to a reduction in future dementia disease burden,” she added.

In an accompanying editorial), Jennifer Deal, PhD, department of epidemiology and Cochlear Center for Hearing and Public Health, Baltimore, and Julio Rojas, MD, PhD, Memory and Aging Center, department of neurology, Weill Institute for Neurosciences, University of California, San Francisco, call the findings “an important reminder that dementia is a social problem in which potentially treatable risk factors, including visual impairment, are highly prevalent in disadvantaged populations.”

The editorialists noted that 90% of cases of vision impairment are “preventable or have yet to be treated. The two “highly cost-effective interventions” of eyeglasses and/or cataract surgery “remain underused both in the U.S. and globally, especially in disadvantaged communities,” they wrote.

They added that more research is needed to “test the effectiveness of interventions to preserve cognitive health by promoting healthy vision.”

The study was supported by grants from the National Institute on Aging, the National Institutes of Health, and Research to Prevent Blindness. The investigators reported no relevant financial relationships. Dr. Deal reported having received grants from the National Institute on Aging. Dr. Rojas reported serving as site principal investigator on clinical trials for Eli Lilly and Eisai and receiving grants from the National Institute on Aging. Dr. Pershing is a consultant for Acumen, and Verana Health (as DigiSight Technologies).

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

Impaired vision in older adults is an underrecognized and modifiable dementia risk factor, new research suggests.

Investigators analyzed estimated population attributable fractions (PAFs) associated with dementia in more than 16,000 older adults. A PAF represents the number of dementia cases that could be prevented if a given risk factor were eliminated.

Results showed the PAF of vision impairment was 1.8%, suggesting that healthy vision had the potential to prevent more than 100,000 cases of dementia in the United States.

“Vision impairment and blindness disproportionately impact older adults, yet vision impairment is often preventable or even correctable,” study investigator Joshua Ehrlich MD, assistant professor of ophthalmology and visual sciences, University of Michigan, Ann Arbor, said in an interview.

Poor vision affects not only how individuals see the world, but also their systemic health and well-being, Dr. Ehrlich said.

“Accordingly, ensuring that older adults receive appropriate eye care is vital to promoting health, independence, and optimal aging,” he added.

The findings were published online in JAMA Neurology.
 

A surprising omission

There is an “urgent need to identify modifiable risk factors for dementia that can be targeted with interventions to slow cognitive decline and prevent dementia,” the investigators wrote.

In 2020, the Lancet Commission report on dementia prevention, intervention, and care proposed a life-course model of 12 potentially modifiable dementia risk factors. This included lower educational level, hearing loss, traumatic brain injury, hypertension, excessive alcohol consumption, obesity, smoking, depression, social isolation, physical inactivity, diabetes, and air pollution.

Together, these factors are associated with about 40% of dementia cases worldwide, the report notes.

Vision impairment was not included in this model, “despite considerable evidence that it is associated with an elevated risk of incident dementia and that it may operate through the same pathways as hearing loss,” the current researchers wrote.

“We have known for some time that vision impairment is a risk factor for dementia [and] we also know that a very large fraction of vision impairment, possibly in excess of 80%, is avoidable or has simply yet to be addressed,” Dr. Ehrlich said.

He and his colleagues found it “surprising that vision impairment had been ignored in key models of modifiable dementia risk factors that are used to shape health policy and resource allocation.” They set out to demonstrate that, “in fact, vision impairment is just as influential as a number of other long accepted modifiable dementia risk factors.”

The investigators assessed data from the Health and Retirement Study (HRS), a panel study that surveys more than 20,000 U.S. adults aged 50 years or older every 2 years.

The investigators applied the same methods used by the Lancet Commission to the HRS dataset and added vision impairment to the Lancet life-course model. Air pollution was excluded in their model “because those data were not readily available in the HRS,” the researchers wrote.

They noted the PAF is “based on the population prevalence and relative risk of dementia for each risk factor” and is “weighted, based on a principal components analysis, to account for communality (clustering of risk factors).”
 

A missed prevention opportunity

The sample included 16,690 participants (54% were women, 51.5% were at least age 65, 80.2% were White, 10.6% were Black, 9.2% were other).

In total, the 12 potentially modifiable risk factors used in the researchers’ model were associated with an estimated 62.4% of dementia cases in the United States, with hypertension as the most prevalent risk factor with the highest weighted PAF.
 

A new focus for prevention

Commenting for this article, Suzann Pershing, MD, associate professor of ophthalmology, Stanford (Calif.) University, called the study “particularly important because, despite growing recognition of its importance in relation to cognition, visual impairment is often an underrecognized risk factor.”

The current research “builds on increasingly robust medical literature linking visual impairment and dementia, applying analogous methods to those used for the life course model recently presented by the Lancet Commission to evaluate potentially modifiable dementia risk factors,” said Dr. Pershing, who was not involved with the study.

The investigators “make a compelling argument for inclusion of visual impairment as one of the potentially modifiable risk factors; practicing clinicians and health care systems may consider screening and targeted therapies to address visual impairment, with a goal of population health and contributing to a reduction in future dementia disease burden,” she added.

In an accompanying editorial), Jennifer Deal, PhD, department of epidemiology and Cochlear Center for Hearing and Public Health, Baltimore, and Julio Rojas, MD, PhD, Memory and Aging Center, department of neurology, Weill Institute for Neurosciences, University of California, San Francisco, call the findings “an important reminder that dementia is a social problem in which potentially treatable risk factors, including visual impairment, are highly prevalent in disadvantaged populations.”

The editorialists noted that 90% of cases of vision impairment are “preventable or have yet to be treated. The two “highly cost-effective interventions” of eyeglasses and/or cataract surgery “remain underused both in the U.S. and globally, especially in disadvantaged communities,” they wrote.

They added that more research is needed to “test the effectiveness of interventions to preserve cognitive health by promoting healthy vision.”

The study was supported by grants from the National Institute on Aging, the National Institutes of Health, and Research to Prevent Blindness. The investigators reported no relevant financial relationships. Dr. Deal reported having received grants from the National Institute on Aging. Dr. Rojas reported serving as site principal investigator on clinical trials for Eli Lilly and Eisai and receiving grants from the National Institute on Aging. Dr. Pershing is a consultant for Acumen, and Verana Health (as DigiSight Technologies).

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

Moderate to severe anxiety, depression, and shortness of breath indicate increased risk for nonfatal self-injury (NFSI) among patients newly diagnosed with cancer, according to a Canadian study.

In a population-based, case-control study, each of these symptoms was associated with an increase of at least 60% in the risk for NFSI in the following 180 days, the investigators report.

“Clinicians should know that self-injury is a real problem after a cancer diagnosis,” lead investigator Julie Hallet, MD, an associate scientist at Sunnybrook Health Sciences Centre in Toronto, told this news organization.

Self-injury “does not necessarily represent an attempted suicide,” she added. “While our data do not allow us to know what the intent was, we know from other work that the repercussions of distress in patients with cancer are much broader than suicide. Self-injury can be a means to cope with psychological difficulties for some patients, without intent for suicide.”

The study was published online in JAMA Oncology.
 

Nine common symptoms

The study included adults who were diagnosed with cancer between Jan. 1, 2007, and March 31, 2019, and had completed the Edmonton Symptom Assessment System (ESAS) evaluation within 36 months of their index cancer diagnosis. ESAS evaluates nine common cancer-associated symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath, on a patient-reported scale of 0 (absence of symptom) to 10 (worst possible symptom).

The analysis included 406 patients who had visited an emergency department for an NFSI within 180 days of their ESAS evaluation, as well as 1,624 matched control patients with cancer who did not have an NFSI. Case patients and control patients were matched according to age at cancer diagnosis, sex, prior self-injury within 5 years of being diagnosed with cancer, and cancer type. Nonmatched covariates included psychiatric illness and therapy received before NFSI, comorbidity burden, material deprivation, and cancer stage.
 

Toward tailored intervention

A higher proportion of case patients than control patients reported moderate to severe scores for all nine ESAS symptoms. In an adjusted analysis, moderate to severe anxiety (odds ratio, 1.61), depression (OR, 1.66), and shortness of breath (OR, 1.65) were independently associated with higher odds of subsequent NFSI. Each 10-point increase in total ESAS score also was associated with increased risk (OR, 1.51).

“These findings are important to enhance the use of screening ESAS scores to better support patients,” say the authors. “Scores from ESAS assessments can be used to identify patients at higher risk of NFSI, indicating higher level of distress, and help direct tailored assessment and intervention.”

In prior work, Dr. Hallet’s group showed that NFSI occurs in 3 of every 1,000 patients with cancer. NFSI is more frequent among younger patients and those with a history of prior mental illness. “Identifying patients at risk in clinical practice requires you to inquire about a patient’s prior history, identify high symptom scores and ask about them, and trigger intervention pathways when risk is identified,” said Dr. Hallet.

“For example, a young patient with head and neck cancer and a prior history of mental illness who reports high scores for anxiety and drowsiness would be at high risk of self-injury,” she added. Such a patient should be referred to psycho-oncology, psychiatry, or social work. “To facilitate this, we are working on prognostic scores that can be integrated in clinical practice, such as an electronic medical record, to flag patients at risk,” said Dr. Hallet. “Future work will also need to identify the optimal care pathways for at-risk patients.”
 

Self-injury vs. suicidality

Commenting on the study for this news organization, Madeline Li, MD, PhD, a psychiatrist and clinician-scientist at Toronto’s Princess Margaret Cancer Centre, said that the findings are “underwhelming” because they tell us what is already known – that “NFSI is associated with distress, and cancer is a stressor.” It would have been more interesting to ask how to distinguish patients at risk for suicide from those at risk for self-harm without suicide, she added.

“The way these authors formulated NFSI included both self-harm intent and suicidal intent,” she explained. The researchers compared patients who were at risk for these two types of events with patients without NFSI. “When we see self-harm without suicidal intent in the emergency room, it’s mostly people making cries for help,” said Dr. Li. “These are people who cut their wrists or take small overdoses on purpose without the intent to die. It would have been more interesting to see if there are different risk factors for people who are just going to self-harm vs. those who are actually going to attempt suicide.”

The study’s identification of risk factors for NSFI is important because “it does tell us that when there’s anxiety, depression, and shortness of breath, we should pay attention to these patients and do something about it,” said Dr. Li. Still, research in cancer psychiatry needs to shift its focus from identifying and addressing existing risk factors to preventing them from developing, she added.

“We need to move earlier and provide emotional and mental health support to cancer patients to prevent them from becoming suicidal, rather than intervening when somebody already is,” Dr. Li concluded.

The study was funded by the Hanna Research Award from the division of surgical oncology at the Odette Cancer Centre–Sunnybrook Health Sciences Centre and by a Sunnybrook Health Sciences Centre Alternate Funding Plan Innovation grant. It was also supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Dr. Hallet has received personal fees from Ipsen Biopharmaceuticals Canada and AAA outside the submitted work. Dr. Li reported no relevant financial relationships.

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

Moderate to severe anxiety, depression, and shortness of breath indicate increased risk for nonfatal self-injury (NFSI) among patients newly diagnosed with cancer, according to a Canadian study.

In a population-based, case-control study, each of these symptoms was associated with an increase of at least 60% in the risk for NFSI in the following 180 days, the investigators report.

“Clinicians should know that self-injury is a real problem after a cancer diagnosis,” lead investigator Julie Hallet, MD, an associate scientist at Sunnybrook Health Sciences Centre in Toronto, told this news organization.

Self-injury “does not necessarily represent an attempted suicide,” she added. “While our data do not allow us to know what the intent was, we know from other work that the repercussions of distress in patients with cancer are much broader than suicide. Self-injury can be a means to cope with psychological difficulties for some patients, without intent for suicide.”

The study was published online in JAMA Oncology.
 

Nine common symptoms

The study included adults who were diagnosed with cancer between Jan. 1, 2007, and March 31, 2019, and had completed the Edmonton Symptom Assessment System (ESAS) evaluation within 36 months of their index cancer diagnosis. ESAS evaluates nine common cancer-associated symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath, on a patient-reported scale of 0 (absence of symptom) to 10 (worst possible symptom).

The analysis included 406 patients who had visited an emergency department for an NFSI within 180 days of their ESAS evaluation, as well as 1,624 matched control patients with cancer who did not have an NFSI. Case patients and control patients were matched according to age at cancer diagnosis, sex, prior self-injury within 5 years of being diagnosed with cancer, and cancer type. Nonmatched covariates included psychiatric illness and therapy received before NFSI, comorbidity burden, material deprivation, and cancer stage.
 

Toward tailored intervention

A higher proportion of case patients than control patients reported moderate to severe scores for all nine ESAS symptoms. In an adjusted analysis, moderate to severe anxiety (odds ratio, 1.61), depression (OR, 1.66), and shortness of breath (OR, 1.65) were independently associated with higher odds of subsequent NFSI. Each 10-point increase in total ESAS score also was associated with increased risk (OR, 1.51).

“These findings are important to enhance the use of screening ESAS scores to better support patients,” say the authors. “Scores from ESAS assessments can be used to identify patients at higher risk of NFSI, indicating higher level of distress, and help direct tailored assessment and intervention.”

In prior work, Dr. Hallet’s group showed that NFSI occurs in 3 of every 1,000 patients with cancer. NFSI is more frequent among younger patients and those with a history of prior mental illness. “Identifying patients at risk in clinical practice requires you to inquire about a patient’s prior history, identify high symptom scores and ask about them, and trigger intervention pathways when risk is identified,” said Dr. Hallet.

“For example, a young patient with head and neck cancer and a prior history of mental illness who reports high scores for anxiety and drowsiness would be at high risk of self-injury,” she added. Such a patient should be referred to psycho-oncology, psychiatry, or social work. “To facilitate this, we are working on prognostic scores that can be integrated in clinical practice, such as an electronic medical record, to flag patients at risk,” said Dr. Hallet. “Future work will also need to identify the optimal care pathways for at-risk patients.”
 

Self-injury vs. suicidality

Commenting on the study for this news organization, Madeline Li, MD, PhD, a psychiatrist and clinician-scientist at Toronto’s Princess Margaret Cancer Centre, said that the findings are “underwhelming” because they tell us what is already known – that “NFSI is associated with distress, and cancer is a stressor.” It would have been more interesting to ask how to distinguish patients at risk for suicide from those at risk for self-harm without suicide, she added.

“The way these authors formulated NFSI included both self-harm intent and suicidal intent,” she explained. The researchers compared patients who were at risk for these two types of events with patients without NFSI. “When we see self-harm without suicidal intent in the emergency room, it’s mostly people making cries for help,” said Dr. Li. “These are people who cut their wrists or take small overdoses on purpose without the intent to die. It would have been more interesting to see if there are different risk factors for people who are just going to self-harm vs. those who are actually going to attempt suicide.”

The study’s identification of risk factors for NSFI is important because “it does tell us that when there’s anxiety, depression, and shortness of breath, we should pay attention to these patients and do something about it,” said Dr. Li. Still, research in cancer psychiatry needs to shift its focus from identifying and addressing existing risk factors to preventing them from developing, she added.

“We need to move earlier and provide emotional and mental health support to cancer patients to prevent them from becoming suicidal, rather than intervening when somebody already is,” Dr. Li concluded.

The study was funded by the Hanna Research Award from the division of surgical oncology at the Odette Cancer Centre–Sunnybrook Health Sciences Centre and by a Sunnybrook Health Sciences Centre Alternate Funding Plan Innovation grant. It was also supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Dr. Hallet has received personal fees from Ipsen Biopharmaceuticals Canada and AAA outside the submitted work. Dr. Li reported no relevant financial relationships.

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

Moderate to severe anxiety, depression, and shortness of breath indicate increased risk for nonfatal self-injury (NFSI) among patients newly diagnosed with cancer, according to a Canadian study.

In a population-based, case-control study, each of these symptoms was associated with an increase of at least 60% in the risk for NFSI in the following 180 days, the investigators report.

“Clinicians should know that self-injury is a real problem after a cancer diagnosis,” lead investigator Julie Hallet, MD, an associate scientist at Sunnybrook Health Sciences Centre in Toronto, told this news organization.

Self-injury “does not necessarily represent an attempted suicide,” she added. “While our data do not allow us to know what the intent was, we know from other work that the repercussions of distress in patients with cancer are much broader than suicide. Self-injury can be a means to cope with psychological difficulties for some patients, without intent for suicide.”

The study was published online in JAMA Oncology.
 

Nine common symptoms

The study included adults who were diagnosed with cancer between Jan. 1, 2007, and March 31, 2019, and had completed the Edmonton Symptom Assessment System (ESAS) evaluation within 36 months of their index cancer diagnosis. ESAS evaluates nine common cancer-associated symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath, on a patient-reported scale of 0 (absence of symptom) to 10 (worst possible symptom).

The analysis included 406 patients who had visited an emergency department for an NFSI within 180 days of their ESAS evaluation, as well as 1,624 matched control patients with cancer who did not have an NFSI. Case patients and control patients were matched according to age at cancer diagnosis, sex, prior self-injury within 5 years of being diagnosed with cancer, and cancer type. Nonmatched covariates included psychiatric illness and therapy received before NFSI, comorbidity burden, material deprivation, and cancer stage.
 

Toward tailored intervention

A higher proportion of case patients than control patients reported moderate to severe scores for all nine ESAS symptoms. In an adjusted analysis, moderate to severe anxiety (odds ratio, 1.61), depression (OR, 1.66), and shortness of breath (OR, 1.65) were independently associated with higher odds of subsequent NFSI. Each 10-point increase in total ESAS score also was associated with increased risk (OR, 1.51).

“These findings are important to enhance the use of screening ESAS scores to better support patients,” say the authors. “Scores from ESAS assessments can be used to identify patients at higher risk of NFSI, indicating higher level of distress, and help direct tailored assessment and intervention.”

In prior work, Dr. Hallet’s group showed that NFSI occurs in 3 of every 1,000 patients with cancer. NFSI is more frequent among younger patients and those with a history of prior mental illness. “Identifying patients at risk in clinical practice requires you to inquire about a patient’s prior history, identify high symptom scores and ask about them, and trigger intervention pathways when risk is identified,” said Dr. Hallet.

“For example, a young patient with head and neck cancer and a prior history of mental illness who reports high scores for anxiety and drowsiness would be at high risk of self-injury,” she added. Such a patient should be referred to psycho-oncology, psychiatry, or social work. “To facilitate this, we are working on prognostic scores that can be integrated in clinical practice, such as an electronic medical record, to flag patients at risk,” said Dr. Hallet. “Future work will also need to identify the optimal care pathways for at-risk patients.”
 

Self-injury vs. suicidality

Commenting on the study for this news organization, Madeline Li, MD, PhD, a psychiatrist and clinician-scientist at Toronto’s Princess Margaret Cancer Centre, said that the findings are “underwhelming” because they tell us what is already known – that “NFSI is associated with distress, and cancer is a stressor.” It would have been more interesting to ask how to distinguish patients at risk for suicide from those at risk for self-harm without suicide, she added.

“The way these authors formulated NFSI included both self-harm intent and suicidal intent,” she explained. The researchers compared patients who were at risk for these two types of events with patients without NFSI. “When we see self-harm without suicidal intent in the emergency room, it’s mostly people making cries for help,” said Dr. Li. “These are people who cut their wrists or take small overdoses on purpose without the intent to die. It would have been more interesting to see if there are different risk factors for people who are just going to self-harm vs. those who are actually going to attempt suicide.”

The study’s identification of risk factors for NSFI is important because “it does tell us that when there’s anxiety, depression, and shortness of breath, we should pay attention to these patients and do something about it,” said Dr. Li. Still, research in cancer psychiatry needs to shift its focus from identifying and addressing existing risk factors to preventing them from developing, she added.

“We need to move earlier and provide emotional and mental health support to cancer patients to prevent them from becoming suicidal, rather than intervening when somebody already is,” Dr. Li concluded.

The study was funded by the Hanna Research Award from the division of surgical oncology at the Odette Cancer Centre–Sunnybrook Health Sciences Centre and by a Sunnybrook Health Sciences Centre Alternate Funding Plan Innovation grant. It was also supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Dr. Hallet has received personal fees from Ipsen Biopharmaceuticals Canada and AAA outside the submitted work. Dr. Li reported no relevant financial relationships.

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

Fat shaming doesn’t work. If it did, obesity as we know it wouldn’t exist because if the one thing society ensures isn’t lacking for people with obesity, it’s shame. We know that fat shaming doesn’t lead to weight loss and that it’s actually correlated with weight gain: More shame leads to more gain (Puhl and Suh; Sutin and Terracciano; Tomiyama et al).

Shaming and weight stigma have far more concerning associations than weight gain. People who report experiencing more weight stigma have an increased risk for depression, anxiety, low self-esteem, poor body image, substance abuse, suicidality, unhealthy eating behaviors, disordered eating, increased caloric intake, exercise avoidance, decreased exercise motivation potentially due to heightened cortisol reactivity, elevated C-reactive protein, and elevated blood pressure.

Meanwhile, people with obesity – likely in part owing to negative weight-biased experiences in health care – are reluctant to discuss weight with their health care providers and are less likely to seek care at all for any conditions. When care is sought, people with obesity are more likely to receive substandard treatment, including receiving fewer preventive health screenings, decreased health education, and decreased time spent in appointments.
 

Remember that obesity is not a conscious choice

A fact that is conveniently forgotten by those who are most prone to fat shaming is that obesity, like every chronic noncommunicable disease, isn’t a choice that is consciously made by patients.

And yes, though there are lifestyle means that might affect weight, there are lifestyle means that might affect all chronic diseases – yet obesity is the only one we seem to moralize about. It’s also worth noting that other chronic diseases’ lifestyle levers tend not to be governed by thousands of genes and dozens of hormones; those trying to “lifestyle” their way out of obesity are swimming against strong physiologic currents that influence our most seminally important survival drive: eating.

But forgetting about physiologic currents, there is also staggering privilege associated with intentional perpetual behavior change around food and fitness in the name of health.

Whereas medicine and the world are right and quick to embrace the fights against racism, sexism, and homophobia, the push to confront weight bias is far rarer, despite the fact that it’s been shown to be rampant among health care professionals.
 

Protecting the rights of people with obesity

Perhaps though, times are changing. Movements are popping up to protect the rights of people with obesity while combating hate.

Of note, Brazil seems to have embraced a campaign to fight gordofobia — the Portuguese term used to describe weight-based discrimination. For instance, laws are being passed to ensure appropriate seating is supplied in schools for children with obesity, an annual day was formalized to promote the rights of people with obesity, preferential seating is provided on subways for people with obesity, and fines have been levied against at least one comedian for making fat jokes on the grounds of the state’s duty to protect minorities.

We need to take this fight to medicine. Given the incredibly depressing prevalence of weight bias among trainees, medical schools and residency programs should ensure countering weight bias is not only part of the curriculum but that it’s explicitly examined. National medical licensing examinations should include weight bias as well.

Though we’re closer than ever before to widely effective treatment options for obesity, it’s likely to still be decades before pharmaceutical options to treat obesity are as effective, accepted, and encouraged as medications to treat hypertension, dyslipidemia, diabetes, and more are today.

If you’re curious about your own implicit weight biases, consider taking Harvard’s Implicit Association Test for Weight. You might also want to take a few moments and review the Strategies to Overcome and Prevent Obesity Alliances’ Weight Can’t Wait guide for advice on the management of obesity in primary care.

Treat patients with obesity the same as you would those with any chronic condition.

Also, consider your physical office space. Do you have chairs suitable for patients with obesity (wide base and with arms to help patients rise)? A scale that measures up to high weights that’s in a private location? Appropriately sized blood pressure cuffs?

If not, do you know who is deserving of shame?

Doctors who fat shame or who treat patients with obesity differently than they would any other patient with a chronic medical condition.

Examples include the family doctor who hadn’t checked my patient’s blood pressure in over a decade because he couldn’t be bothered buying an appropriately sized blood pressure cuff. Or the fertility doctor who told one of my patients that perhaps her weight reflected God’s will that she does not have children.

Finally, if reading this article about treating people with obesity the same as you would patients with other chronic, noncommunicable, lifestyle responsive diseases made you angry, there’s a great chance that you’re part of the problem.
 

Dr. Freedhoff, is associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work. He has disclosed the following: He served as a director, officer, partner, employee, adviser, consultant, or trustee for Bariatric Medical Institute and Constant Health; has received research grant from Novo Nordisk, and has publicly shared opinions via Weighty Matters and social media. A version of this article first appeared on Medscape.com.

Fat shaming doesn’t work. If it did, obesity as we know it wouldn’t exist because if the one thing society ensures isn’t lacking for people with obesity, it’s shame. We know that fat shaming doesn’t lead to weight loss and that it’s actually correlated with weight gain: More shame leads to more gain (Puhl and Suh; Sutin and Terracciano; Tomiyama et al).

Shaming and weight stigma have far more concerning associations than weight gain. People who report experiencing more weight stigma have an increased risk for depression, anxiety, low self-esteem, poor body image, substance abuse, suicidality, unhealthy eating behaviors, disordered eating, increased caloric intake, exercise avoidance, decreased exercise motivation potentially due to heightened cortisol reactivity, elevated C-reactive protein, and elevated blood pressure.

Meanwhile, people with obesity – likely in part owing to negative weight-biased experiences in health care – are reluctant to discuss weight with their health care providers and are less likely to seek care at all for any conditions. When care is sought, people with obesity are more likely to receive substandard treatment, including receiving fewer preventive health screenings, decreased health education, and decreased time spent in appointments.
 

Remember that obesity is not a conscious choice

A fact that is conveniently forgotten by those who are most prone to fat shaming is that obesity, like every chronic noncommunicable disease, isn’t a choice that is consciously made by patients.

And yes, though there are lifestyle means that might affect weight, there are lifestyle means that might affect all chronic diseases – yet obesity is the only one we seem to moralize about. It’s also worth noting that other chronic diseases’ lifestyle levers tend not to be governed by thousands of genes and dozens of hormones; those trying to “lifestyle” their way out of obesity are swimming against strong physiologic currents that influence our most seminally important survival drive: eating.

But forgetting about physiologic currents, there is also staggering privilege associated with intentional perpetual behavior change around food and fitness in the name of health.

Whereas medicine and the world are right and quick to embrace the fights against racism, sexism, and homophobia, the push to confront weight bias is far rarer, despite the fact that it’s been shown to be rampant among health care professionals.
 

Protecting the rights of people with obesity

Perhaps though, times are changing. Movements are popping up to protect the rights of people with obesity while combating hate.

Of note, Brazil seems to have embraced a campaign to fight gordofobia — the Portuguese term used to describe weight-based discrimination. For instance, laws are being passed to ensure appropriate seating is supplied in schools for children with obesity, an annual day was formalized to promote the rights of people with obesity, preferential seating is provided on subways for people with obesity, and fines have been levied against at least one comedian for making fat jokes on the grounds of the state’s duty to protect minorities.

We need to take this fight to medicine. Given the incredibly depressing prevalence of weight bias among trainees, medical schools and residency programs should ensure countering weight bias is not only part of the curriculum but that it’s explicitly examined. National medical licensing examinations should include weight bias as well.

Though we’re closer than ever before to widely effective treatment options for obesity, it’s likely to still be decades before pharmaceutical options to treat obesity are as effective, accepted, and encouraged as medications to treat hypertension, dyslipidemia, diabetes, and more are today.

If you’re curious about your own implicit weight biases, consider taking Harvard’s Implicit Association Test for Weight. You might also want to take a few moments and review the Strategies to Overcome and Prevent Obesity Alliances’ Weight Can’t Wait guide for advice on the management of obesity in primary care.

Treat patients with obesity the same as you would those with any chronic condition.

Also, consider your physical office space. Do you have chairs suitable for patients with obesity (wide base and with arms to help patients rise)? A scale that measures up to high weights that’s in a private location? Appropriately sized blood pressure cuffs?

If not, do you know who is deserving of shame?

Doctors who fat shame or who treat patients with obesity differently than they would any other patient with a chronic medical condition.

Examples include the family doctor who hadn’t checked my patient’s blood pressure in over a decade because he couldn’t be bothered buying an appropriately sized blood pressure cuff. Or the fertility doctor who told one of my patients that perhaps her weight reflected God’s will that she does not have children.

Finally, if reading this article about treating people with obesity the same as you would patients with other chronic, noncommunicable, lifestyle responsive diseases made you angry, there’s a great chance that you’re part of the problem.
 

Dr. Freedhoff, is associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work. He has disclosed the following: He served as a director, officer, partner, employee, adviser, consultant, or trustee for Bariatric Medical Institute and Constant Health; has received research grant from Novo Nordisk, and has publicly shared opinions via Weighty Matters and social media. A version of this article first appeared on Medscape.com.

Fat shaming doesn’t work. If it did, obesity as we know it wouldn’t exist because if the one thing society ensures isn’t lacking for people with obesity, it’s shame. We know that fat shaming doesn’t lead to weight loss and that it’s actually correlated with weight gain: More shame leads to more gain (Puhl and Suh; Sutin and Terracciano; Tomiyama et al).

Shaming and weight stigma have far more concerning associations than weight gain. People who report experiencing more weight stigma have an increased risk for depression, anxiety, low self-esteem, poor body image, substance abuse, suicidality, unhealthy eating behaviors, disordered eating, increased caloric intake, exercise avoidance, decreased exercise motivation potentially due to heightened cortisol reactivity, elevated C-reactive protein, and elevated blood pressure.

Meanwhile, people with obesity – likely in part owing to negative weight-biased experiences in health care – are reluctant to discuss weight with their health care providers and are less likely to seek care at all for any conditions. When care is sought, people with obesity are more likely to receive substandard treatment, including receiving fewer preventive health screenings, decreased health education, and decreased time spent in appointments.
 

Remember that obesity is not a conscious choice

A fact that is conveniently forgotten by those who are most prone to fat shaming is that obesity, like every chronic noncommunicable disease, isn’t a choice that is consciously made by patients.

And yes, though there are lifestyle means that might affect weight, there are lifestyle means that might affect all chronic diseases – yet obesity is the only one we seem to moralize about. It’s also worth noting that other chronic diseases’ lifestyle levers tend not to be governed by thousands of genes and dozens of hormones; those trying to “lifestyle” their way out of obesity are swimming against strong physiologic currents that influence our most seminally important survival drive: eating.

But forgetting about physiologic currents, there is also staggering privilege associated with intentional perpetual behavior change around food and fitness in the name of health.

Whereas medicine and the world are right and quick to embrace the fights against racism, sexism, and homophobia, the push to confront weight bias is far rarer, despite the fact that it’s been shown to be rampant among health care professionals.
 

Protecting the rights of people with obesity

Perhaps though, times are changing. Movements are popping up to protect the rights of people with obesity while combating hate.

Of note, Brazil seems to have embraced a campaign to fight gordofobia — the Portuguese term used to describe weight-based discrimination. For instance, laws are being passed to ensure appropriate seating is supplied in schools for children with obesity, an annual day was formalized to promote the rights of people with obesity, preferential seating is provided on subways for people with obesity, and fines have been levied against at least one comedian for making fat jokes on the grounds of the state’s duty to protect minorities.

We need to take this fight to medicine. Given the incredibly depressing prevalence of weight bias among trainees, medical schools and residency programs should ensure countering weight bias is not only part of the curriculum but that it’s explicitly examined. National medical licensing examinations should include weight bias as well.

Though we’re closer than ever before to widely effective treatment options for obesity, it’s likely to still be decades before pharmaceutical options to treat obesity are as effective, accepted, and encouraged as medications to treat hypertension, dyslipidemia, diabetes, and more are today.

If you’re curious about your own implicit weight biases, consider taking Harvard’s Implicit Association Test for Weight. You might also want to take a few moments and review the Strategies to Overcome and Prevent Obesity Alliances’ Weight Can’t Wait guide for advice on the management of obesity in primary care.

Treat patients with obesity the same as you would those with any chronic condition.

Also, consider your physical office space. Do you have chairs suitable for patients with obesity (wide base and with arms to help patients rise)? A scale that measures up to high weights that’s in a private location? Appropriately sized blood pressure cuffs?

If not, do you know who is deserving of shame?

Doctors who fat shame or who treat patients with obesity differently than they would any other patient with a chronic medical condition.

Examples include the family doctor who hadn’t checked my patient’s blood pressure in over a decade because he couldn’t be bothered buying an appropriately sized blood pressure cuff. Or the fertility doctor who told one of my patients that perhaps her weight reflected God’s will that she does not have children.

Finally, if reading this article about treating people with obesity the same as you would patients with other chronic, noncommunicable, lifestyle responsive diseases made you angry, there’s a great chance that you’re part of the problem.
 

Dr. Freedhoff, is associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute, a nonsurgical weight management center. He is one of Canada’s most outspoken obesity experts and the author of The Diet Fix: Why Diets Fail and How to Make Yours Work. He has disclosed the following: He served as a director, officer, partner, employee, adviser, consultant, or trustee for Bariatric Medical Institute and Constant Health; has received research grant from Novo Nordisk, and has publicly shared opinions via Weighty Matters and social media. A version of this article first appeared on Medscape.com.

An estimated 15% of Americans over age 65 years who aren’t living in institutions are considered frail – a complex geriatric syndrome that raises the odds of disability, hospitalization, the need for nursing care, and death.

But while the word frailty may conjure images of wizened and weakened men and women, the clinical picture is far less clear.

“We’ve made a lot of progress in some ways, but still a lot of work to be done in others,” George A. Kuchel, MD, CM, the chair in geriatrics and gerontology and director of the UConn Center on Aging in Farmington, Conn., said at the annual meeting of the American College of Physicians.

“You have to be very careful about generalizations,” Dr. Kuchel said. “This is very important when you are thinking about managing it.”

One of the key take-home messages, Dr. Kuchel said, “and one of the first things I learned as a geriatrics fellow, is that when you have seen one older person, all you have seen is one older person.”

What this means is that while all people age, there is tremendous variance in how they age. “Some become quite frail and disabled and need to be in a nursing home, while some age gracefully and are living well,” he said. “Most fall somewhere in between.”

The second major take-home is that frailty is multifactorial – a critical consideration when it comes to managing elderly patients.

“Unlike other conditions, there is no single medication, there is no one single thing you can do – it is really multifactorial,” he said. “What it means is to match the components to target unique needs, and that is something that we are calling ‘precision gerontology,’ as opposed to precision medicine.”

The definitions of frailty vary but can involve increased vulnerability; enhanced risk of declining function, disability, and death; and a decline in functioning across multiple physiologic systems, accompanied by an increased vulnerability to stressors.

Key features that clinicians should emphasize include multifactorial etiology with each risk factor contributing only modestly:

• Multidimensional nature, with physical and psychosocial factors playing a part.
• Frailty represents an extreme consequence of the normal aging process.
• The process is dynamic, and individuals can fluctuate between frailty states.

Diagnosing frailty

Diagnosing frailty in the average clinical setting can be a challenge. Unlike other disorders, no single test or assessment tool exists for the condition. Most settings or patients, for example, do not even have the device to measure hand grip strength, Dr. Kuchel said. Other obstacles include a lack of time and reimbursement.

However, clinicians can quickly and easily assess patients for several warning signs, including the presence of multimorbidity (>5 diseases), slow walking speed (<1 m/sec), inability to climb a flight of stairs, and/or walk a block or rise from chair five times with arms folded.

“These are simple questions that can be asked by a medical assistant or even over the phone ahead of time,” he said.

Frailty and sarcopenia are closely linked but are not equivalent. As a result, dual-energy x-ray absorptiometry (DXA), which can measure both bone mineral density and muscle mass, is not a good assessment of frailty because muscle mass by itself is not necessarily tied to weakness. Instead, Dr. Kuchel said, measuring muscle function and quality is much more effective at identifying frail patients.  

“Gait velocity is potentially the greatest single measure, and if there is one thing you should do with your patient, it is to check gait velocity,” Dr. Kuchel said. Researchers at his facility are working on radio technology identification-based device that allows for measuring gait when a patient walks down the hallway.

“Measuring gait should be the sixth vital sign, and you need to have that information in front of you when working with older patients,” he said. “We are working on integrating it into our system.”
 

Managing frailty

Although no single intervention for frailty exists, physical activity has been shown to delay its onset. Still, Dr. Kuchel said, clinicians can try a range of approaches, both biologic and social, to address the condition.

Assessing for and treating depression, for example, may help reduce frailty fatigue, as can stopping medications – including benzodiazepines, and corticosteroids – that might be worsening the condition. Another step is to check for low vitamin D levels and hypothyroidism, he said.

Some patients have unexplained anemia that could be corrected, as well as correcting basal and orthostatic hypotension, which can arise from overtreatment, Dr. Kuchel added.

People with HIV can experience accelerated aging, as can adults who were treated with chemotherapy and radiation as children. “We are also beginning to see some of this with long COVID, so there seems to be some overlap,” he said.

Finally, socioeconomic considerations include the possibility of elder neglect and/or abuse, and the effects of poverty on nutrition and the ability to pay for needed medications.

The bottom line, Dr. Kuchel said, is that managing frailty is possible, but doing so effectively may require stops and starts.

“Correct what is correctable, such as nutrition, vitamin D, depression, and stopping offending meds,” he said. “Match multicomponent interventions with deficits and interventions targeting health care systems will include better care coordination. A comprehensive geriatric assessment is important in the care of this geriatric syndrome.

Dr. Kuchel has disclosed no relevant financial relationships.

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

An estimated 15% of Americans over age 65 years who aren’t living in institutions are considered frail – a complex geriatric syndrome that raises the odds of disability, hospitalization, the need for nursing care, and death.

But while the word frailty may conjure images of wizened and weakened men and women, the clinical picture is far less clear.

“We’ve made a lot of progress in some ways, but still a lot of work to be done in others,” George A. Kuchel, MD, CM, the chair in geriatrics and gerontology and director of the UConn Center on Aging in Farmington, Conn., said at the annual meeting of the American College of Physicians.

“You have to be very careful about generalizations,” Dr. Kuchel said. “This is very important when you are thinking about managing it.”

One of the key take-home messages, Dr. Kuchel said, “and one of the first things I learned as a geriatrics fellow, is that when you have seen one older person, all you have seen is one older person.”

What this means is that while all people age, there is tremendous variance in how they age. “Some become quite frail and disabled and need to be in a nursing home, while some age gracefully and are living well,” he said. “Most fall somewhere in between.”

The second major take-home is that frailty is multifactorial – a critical consideration when it comes to managing elderly patients.

“Unlike other conditions, there is no single medication, there is no one single thing you can do – it is really multifactorial,” he said. “What it means is to match the components to target unique needs, and that is something that we are calling ‘precision gerontology,’ as opposed to precision medicine.”

The definitions of frailty vary but can involve increased vulnerability; enhanced risk of declining function, disability, and death; and a decline in functioning across multiple physiologic systems, accompanied by an increased vulnerability to stressors.

Key features that clinicians should emphasize include multifactorial etiology with each risk factor contributing only modestly:

• Multidimensional nature, with physical and psychosocial factors playing a part.
• Frailty represents an extreme consequence of the normal aging process.
• The process is dynamic, and individuals can fluctuate between frailty states.

Diagnosing frailty

Diagnosing frailty in the average clinical setting can be a challenge. Unlike other disorders, no single test or assessment tool exists for the condition. Most settings or patients, for example, do not even have the device to measure hand grip strength, Dr. Kuchel said. Other obstacles include a lack of time and reimbursement.

However, clinicians can quickly and easily assess patients for several warning signs, including the presence of multimorbidity (>5 diseases), slow walking speed (<1 m/sec), inability to climb a flight of stairs, and/or walk a block or rise from chair five times with arms folded.

“These are simple questions that can be asked by a medical assistant or even over the phone ahead of time,” he said.

Frailty and sarcopenia are closely linked but are not equivalent. As a result, dual-energy x-ray absorptiometry (DXA), which can measure both bone mineral density and muscle mass, is not a good assessment of frailty because muscle mass by itself is not necessarily tied to weakness. Instead, Dr. Kuchel said, measuring muscle function and quality is much more effective at identifying frail patients.  

“Gait velocity is potentially the greatest single measure, and if there is one thing you should do with your patient, it is to check gait velocity,” Dr. Kuchel said. Researchers at his facility are working on radio technology identification-based device that allows for measuring gait when a patient walks down the hallway.

“Measuring gait should be the sixth vital sign, and you need to have that information in front of you when working with older patients,” he said. “We are working on integrating it into our system.”
 

Managing frailty

Although no single intervention for frailty exists, physical activity has been shown to delay its onset. Still, Dr. Kuchel said, clinicians can try a range of approaches, both biologic and social, to address the condition.

Assessing for and treating depression, for example, may help reduce frailty fatigue, as can stopping medications – including benzodiazepines, and corticosteroids – that might be worsening the condition. Another step is to check for low vitamin D levels and hypothyroidism, he said.

Some patients have unexplained anemia that could be corrected, as well as correcting basal and orthostatic hypotension, which can arise from overtreatment, Dr. Kuchel added.

People with HIV can experience accelerated aging, as can adults who were treated with chemotherapy and radiation as children. “We are also beginning to see some of this with long COVID, so there seems to be some overlap,” he said.

Finally, socioeconomic considerations include the possibility of elder neglect and/or abuse, and the effects of poverty on nutrition and the ability to pay for needed medications.

The bottom line, Dr. Kuchel said, is that managing frailty is possible, but doing so effectively may require stops and starts.

“Correct what is correctable, such as nutrition, vitamin D, depression, and stopping offending meds,” he said. “Match multicomponent interventions with deficits and interventions targeting health care systems will include better care coordination. A comprehensive geriatric assessment is important in the care of this geriatric syndrome.

Dr. Kuchel has disclosed no relevant financial relationships.

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

An estimated 15% of Americans over age 65 years who aren’t living in institutions are considered frail – a complex geriatric syndrome that raises the odds of disability, hospitalization, the need for nursing care, and death.

But while the word frailty may conjure images of wizened and weakened men and women, the clinical picture is far less clear.

“We’ve made a lot of progress in some ways, but still a lot of work to be done in others,” George A. Kuchel, MD, CM, the chair in geriatrics and gerontology and director of the UConn Center on Aging in Farmington, Conn., said at the annual meeting of the American College of Physicians.

“You have to be very careful about generalizations,” Dr. Kuchel said. “This is very important when you are thinking about managing it.”

One of the key take-home messages, Dr. Kuchel said, “and one of the first things I learned as a geriatrics fellow, is that when you have seen one older person, all you have seen is one older person.”

What this means is that while all people age, there is tremendous variance in how they age. “Some become quite frail and disabled and need to be in a nursing home, while some age gracefully and are living well,” he said. “Most fall somewhere in between.”

The second major take-home is that frailty is multifactorial – a critical consideration when it comes to managing elderly patients.

“Unlike other conditions, there is no single medication, there is no one single thing you can do – it is really multifactorial,” he said. “What it means is to match the components to target unique needs, and that is something that we are calling ‘precision gerontology,’ as opposed to precision medicine.”

The definitions of frailty vary but can involve increased vulnerability; enhanced risk of declining function, disability, and death; and a decline in functioning across multiple physiologic systems, accompanied by an increased vulnerability to stressors.

Key features that clinicians should emphasize include multifactorial etiology with each risk factor contributing only modestly:

• Multidimensional nature, with physical and psychosocial factors playing a part.
• Frailty represents an extreme consequence of the normal aging process.
• The process is dynamic, and individuals can fluctuate between frailty states.

Diagnosing frailty

Diagnosing frailty in the average clinical setting can be a challenge. Unlike other disorders, no single test or assessment tool exists for the condition. Most settings or patients, for example, do not even have the device to measure hand grip strength, Dr. Kuchel said. Other obstacles include a lack of time and reimbursement.

However, clinicians can quickly and easily assess patients for several warning signs, including the presence of multimorbidity (>5 diseases), slow walking speed (<1 m/sec), inability to climb a flight of stairs, and/or walk a block or rise from chair five times with arms folded.

“These are simple questions that can be asked by a medical assistant or even over the phone ahead of time,” he said.

Frailty and sarcopenia are closely linked but are not equivalent. As a result, dual-energy x-ray absorptiometry (DXA), which can measure both bone mineral density and muscle mass, is not a good assessment of frailty because muscle mass by itself is not necessarily tied to weakness. Instead, Dr. Kuchel said, measuring muscle function and quality is much more effective at identifying frail patients.  

“Gait velocity is potentially the greatest single measure, and if there is one thing you should do with your patient, it is to check gait velocity,” Dr. Kuchel said. Researchers at his facility are working on radio technology identification-based device that allows for measuring gait when a patient walks down the hallway.

“Measuring gait should be the sixth vital sign, and you need to have that information in front of you when working with older patients,” he said. “We are working on integrating it into our system.”
 

Managing frailty

Although no single intervention for frailty exists, physical activity has been shown to delay its onset. Still, Dr. Kuchel said, clinicians can try a range of approaches, both biologic and social, to address the condition.

Assessing for and treating depression, for example, may help reduce frailty fatigue, as can stopping medications – including benzodiazepines, and corticosteroids – that might be worsening the condition. Another step is to check for low vitamin D levels and hypothyroidism, he said.

Some patients have unexplained anemia that could be corrected, as well as correcting basal and orthostatic hypotension, which can arise from overtreatment, Dr. Kuchel added.

People with HIV can experience accelerated aging, as can adults who were treated with chemotherapy and radiation as children. “We are also beginning to see some of this with long COVID, so there seems to be some overlap,” he said.

Finally, socioeconomic considerations include the possibility of elder neglect and/or abuse, and the effects of poverty on nutrition and the ability to pay for needed medications.

The bottom line, Dr. Kuchel said, is that managing frailty is possible, but doing so effectively may require stops and starts.

“Correct what is correctable, such as nutrition, vitamin D, depression, and stopping offending meds,” he said. “Match multicomponent interventions with deficits and interventions targeting health care systems will include better care coordination. A comprehensive geriatric assessment is important in the care of this geriatric syndrome.

Dr. Kuchel has disclosed no relevant financial relationships.

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