Patients with relapsing-remitting multiple sclerosis (MS) treated with autologous hematopoietic stem cell transplantation (AHSCT) were 74% more likely than were those taking fingolimod to be relapse free 1 year after treatment, a new study suggests.

The multicenter observational study showed that AHSCT was associated with a better overall annual relapse rate and significantly greater disability improvement versus fingolimod. Stem cell transplantation also offered a slight advantage compared with natalizumab but showed no benefit over ocrelizumab.

“Based on these results, we can conclude that in this observational study AHSCT is substantially superior to fingolimod and marginally superior to natalizumab in reducing the risk of posttreatment relapses,” study investigator Tomas Kalincik, MD, PhD, said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Research gap

Prior studies have suggested that AHSCT is associated with better disability outcomes than other immunotherapies in patients with active secondary progressive MS. Findings from another study on long-term efficacy in relapse prevention are also promising.

“The information that we are still lacking is the head-to-head comparison of the effectiveness of AHSCT in relapsing-remitting disease to concrete, highly effective therapies, which is the aim of this current study,” said Dr. Kalincik, professor of neurology at the University of Melbourne and head of the Multiple Sclerosis and Neuroimmunology Service at the Royal Melbourne Hospital, Australia.

The study included 167 patients with relapsing-remitting MS from six centers in Ottawa, Uppsala, Sheffield, Bergen, Sydney, and Melbourne, combined with 1,675 patients from MSBase. Patients were included if they were treated with AHSCT or fingolimod (n = 769), natalizumab (n = 730) or ocrelizumab (n = 343).

Researchers used propensity matching to ensure the AHSCT and disease-modifying therapy (DMT) groups had similar relapse rates and disability scores at baseline. At 1 year, patients who underwent AHSCT were 74% more likely than were those on fingolimod to be relapse free (hazard ratio [HR], 0.26; P < .0001).

The AHSCT group had a lower overall annualized relapse rate (0.09 vs. 0.19, respectively; P < .0001) and a higher cumulative probability of remaining relapse free at 2 years (90% vs. 68%, respectively) and 5 years (85% vs. 54%, respectively). AHSCT was associated with significantly better confirmed disability improvement at 6 months compared with fingolimod (HR, 2.70; P < .0001).

The researchers found better outcomes with AHSCT compared with natalizumab, but the results weren’t as promising. The annual relapse rate with AHSCT was statistically significant (P = .03) but the clinical benefit was marginal, Dr. Kalincik said. However, the confirmed disability improvement was significantly better with AHSCT (HR, 2.68; P < .0001).

There was no significant difference in outcomes with AHSCT compared to ocrelizumab.

Adverse events were common with stem cell transplantation, a sticking point for at least one conference attendee who raised safety concerns. Among those treated with AHSCT, 23% had febrile neutropenia, 11% had serum sickness, and 36% experienced complications after discharge, mostly infection. There was one AHSCT treatment-related death.

“We’re showing that AHSCT is a highly potent therapy that definitely is competitive vis a vis the most potent standard conventional disease modifying therapies,” said Dr. Kalincik, who noted the high rate of adverse events. Still, treatment-related mortality from AHSCT has improved since the therapy was first used in MS patients, he added.

“I’m hoping the data provides some evidence to convince you that this treatment still has a place in our armamentarium,” Dr. Kalincik said.
 

Questions remain

Eva Kubala Havrdová, MD, PhD, professor of neurology in the Multiple Sclerosis Center at Charles University in Prague, Czech Republic, said the results add to a growing body of data on the efficacy of AHSCT in patients with highly active relapsing-remitting MS, but questions remain.

“It is important to understand that AHSCT provides advantage in terms of effectiveness compared with most of the DMTs,” Dr. Kubala Havrdová said. “However, it is a therapy associated with high risk of adverse events and this needs to be considered when one decides whether other, less invasive options have been exploited.”

Study funding was not reported. Dr. Kalincik disclosed ties with BioCSL, Biogen, BMS, Celgene, Eisai, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Teva, and WebMD Global. Dr. Kubala Havrdová reported no relevant financial relationships.

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

Patients with relapsing-remitting multiple sclerosis (MS) treated with autologous hematopoietic stem cell transplantation (AHSCT) were 74% more likely than were those taking fingolimod to be relapse free 1 year after treatment, a new study suggests.

The multicenter observational study showed that AHSCT was associated with a better overall annual relapse rate and significantly greater disability improvement versus fingolimod. Stem cell transplantation also offered a slight advantage compared with natalizumab but showed no benefit over ocrelizumab.

“Based on these results, we can conclude that in this observational study AHSCT is substantially superior to fingolimod and marginally superior to natalizumab in reducing the risk of posttreatment relapses,” study investigator Tomas Kalincik, MD, PhD, said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Research gap

Prior studies have suggested that AHSCT is associated with better disability outcomes than other immunotherapies in patients with active secondary progressive MS. Findings from another study on long-term efficacy in relapse prevention are also promising.

“The information that we are still lacking is the head-to-head comparison of the effectiveness of AHSCT in relapsing-remitting disease to concrete, highly effective therapies, which is the aim of this current study,” said Dr. Kalincik, professor of neurology at the University of Melbourne and head of the Multiple Sclerosis and Neuroimmunology Service at the Royal Melbourne Hospital, Australia.

The study included 167 patients with relapsing-remitting MS from six centers in Ottawa, Uppsala, Sheffield, Bergen, Sydney, and Melbourne, combined with 1,675 patients from MSBase. Patients were included if they were treated with AHSCT or fingolimod (n = 769), natalizumab (n = 730) or ocrelizumab (n = 343).

Researchers used propensity matching to ensure the AHSCT and disease-modifying therapy (DMT) groups had similar relapse rates and disability scores at baseline. At 1 year, patients who underwent AHSCT were 74% more likely than were those on fingolimod to be relapse free (hazard ratio [HR], 0.26; P < .0001).

The AHSCT group had a lower overall annualized relapse rate (0.09 vs. 0.19, respectively; P < .0001) and a higher cumulative probability of remaining relapse free at 2 years (90% vs. 68%, respectively) and 5 years (85% vs. 54%, respectively). AHSCT was associated with significantly better confirmed disability improvement at 6 months compared with fingolimod (HR, 2.70; P < .0001).

The researchers found better outcomes with AHSCT compared with natalizumab, but the results weren’t as promising. The annual relapse rate with AHSCT was statistically significant (P = .03) but the clinical benefit was marginal, Dr. Kalincik said. However, the confirmed disability improvement was significantly better with AHSCT (HR, 2.68; P < .0001).

There was no significant difference in outcomes with AHSCT compared to ocrelizumab.

Adverse events were common with stem cell transplantation, a sticking point for at least one conference attendee who raised safety concerns. Among those treated with AHSCT, 23% had febrile neutropenia, 11% had serum sickness, and 36% experienced complications after discharge, mostly infection. There was one AHSCT treatment-related death.

“We’re showing that AHSCT is a highly potent therapy that definitely is competitive vis a vis the most potent standard conventional disease modifying therapies,” said Dr. Kalincik, who noted the high rate of adverse events. Still, treatment-related mortality from AHSCT has improved since the therapy was first used in MS patients, he added.

“I’m hoping the data provides some evidence to convince you that this treatment still has a place in our armamentarium,” Dr. Kalincik said.
 

Questions remain

Eva Kubala Havrdová, MD, PhD, professor of neurology in the Multiple Sclerosis Center at Charles University in Prague, Czech Republic, said the results add to a growing body of data on the efficacy of AHSCT in patients with highly active relapsing-remitting MS, but questions remain.

“It is important to understand that AHSCT provides advantage in terms of effectiveness compared with most of the DMTs,” Dr. Kubala Havrdová said. “However, it is a therapy associated with high risk of adverse events and this needs to be considered when one decides whether other, less invasive options have been exploited.”

Study funding was not reported. Dr. Kalincik disclosed ties with BioCSL, Biogen, BMS, Celgene, Eisai, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Teva, and WebMD Global. Dr. Kubala Havrdová reported no relevant financial relationships.

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

Patients with relapsing-remitting multiple sclerosis (MS) treated with autologous hematopoietic stem cell transplantation (AHSCT) were 74% more likely than were those taking fingolimod to be relapse free 1 year after treatment, a new study suggests.

The multicenter observational study showed that AHSCT was associated with a better overall annual relapse rate and significantly greater disability improvement versus fingolimod. Stem cell transplantation also offered a slight advantage compared with natalizumab but showed no benefit over ocrelizumab.

“Based on these results, we can conclude that in this observational study AHSCT is substantially superior to fingolimod and marginally superior to natalizumab in reducing the risk of posttreatment relapses,” study investigator Tomas Kalincik, MD, PhD, said at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Research gap

Prior studies have suggested that AHSCT is associated with better disability outcomes than other immunotherapies in patients with active secondary progressive MS. Findings from another study on long-term efficacy in relapse prevention are also promising.

“The information that we are still lacking is the head-to-head comparison of the effectiveness of AHSCT in relapsing-remitting disease to concrete, highly effective therapies, which is the aim of this current study,” said Dr. Kalincik, professor of neurology at the University of Melbourne and head of the Multiple Sclerosis and Neuroimmunology Service at the Royal Melbourne Hospital, Australia.

The study included 167 patients with relapsing-remitting MS from six centers in Ottawa, Uppsala, Sheffield, Bergen, Sydney, and Melbourne, combined with 1,675 patients from MSBase. Patients were included if they were treated with AHSCT or fingolimod (n = 769), natalizumab (n = 730) or ocrelizumab (n = 343).

Researchers used propensity matching to ensure the AHSCT and disease-modifying therapy (DMT) groups had similar relapse rates and disability scores at baseline. At 1 year, patients who underwent AHSCT were 74% more likely than were those on fingolimod to be relapse free (hazard ratio [HR], 0.26; P < .0001).

The AHSCT group had a lower overall annualized relapse rate (0.09 vs. 0.19, respectively; P < .0001) and a higher cumulative probability of remaining relapse free at 2 years (90% vs. 68%, respectively) and 5 years (85% vs. 54%, respectively). AHSCT was associated with significantly better confirmed disability improvement at 6 months compared with fingolimod (HR, 2.70; P < .0001).

The researchers found better outcomes with AHSCT compared with natalizumab, but the results weren’t as promising. The annual relapse rate with AHSCT was statistically significant (P = .03) but the clinical benefit was marginal, Dr. Kalincik said. However, the confirmed disability improvement was significantly better with AHSCT (HR, 2.68; P < .0001).

There was no significant difference in outcomes with AHSCT compared to ocrelizumab.

Adverse events were common with stem cell transplantation, a sticking point for at least one conference attendee who raised safety concerns. Among those treated with AHSCT, 23% had febrile neutropenia, 11% had serum sickness, and 36% experienced complications after discharge, mostly infection. There was one AHSCT treatment-related death.

“We’re showing that AHSCT is a highly potent therapy that definitely is competitive vis a vis the most potent standard conventional disease modifying therapies,” said Dr. Kalincik, who noted the high rate of adverse events. Still, treatment-related mortality from AHSCT has improved since the therapy was first used in MS patients, he added.

“I’m hoping the data provides some evidence to convince you that this treatment still has a place in our armamentarium,” Dr. Kalincik said.
 

Questions remain

Eva Kubala Havrdová, MD, PhD, professor of neurology in the Multiple Sclerosis Center at Charles University in Prague, Czech Republic, said the results add to a growing body of data on the efficacy of AHSCT in patients with highly active relapsing-remitting MS, but questions remain.

“It is important to understand that AHSCT provides advantage in terms of effectiveness compared with most of the DMTs,” Dr. Kubala Havrdová said. “However, it is a therapy associated with high risk of adverse events and this needs to be considered when one decides whether other, less invasive options have been exploited.”

Study funding was not reported. Dr. Kalincik disclosed ties with BioCSL, Biogen, BMS, Celgene, Eisai, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Teva, and WebMD Global. Dr. Kubala Havrdová reported no relevant financial relationships.

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

DENVER – When Arisa E. Ortiz, MD, meets with patients who seek treatment options for scars, the first thing she explains is that she can’t erase them.

“It’s important to manage expectations,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual meeting of the American Society for Dermatologic Surgery. “I tell them I can improve their scar and make it look less noticeable, but I can’t make it look like normal skin. It’s going to require multiple treatments. It’s not a one-time thing; it’s going to take several months to see the full benefit. And, it’s an investment of time and money.”

Nonablative, ablative, and fractional resurfacing stimulates dermal fibroblasts to replace lost collagen and elastin. Traditional lasers offer impressive clinical results for scars but are associated with significant preprocedural discomfort, prolonged recovery, and a significant risk of side effects, Dr. Ortiz said, while nonablative lasers are more tolerable with shorter recovery times.

Multiple sessions are required, and results are often less clinically impressive. “It’s often difficult for patients to have a lot of downtime with each treatment so often I prefer to use the nonablative laser, especially for acne scarring,” she said.

Mounting evidence suggests that the sooner scars are treated after they are formed, the better. That may not be feasible for patients with a long history of acne scars, but for surgical scars, Dr. Ortiz prefers to start treatment on the day of suture removal. “Whenever I do that, I always get better results,” she said.

Outcomes may also improve by combining different treatment options, but the type of scar drives the type of modality to consider. There are red scars from postinflammatory erythema, hyperpigmented scars, hypopigmented scars, atrophic scars, hypertrophic scars, spread scars, pin cushion scars, and keloid scars, “which are the most difficult to treat,” she said. “When I’m using a combination approach, I start with the redness component of the scar, because you don’t want to exacerbate nonspecific erythema, or it’ll be difficult to see where the redness is. So, I always use vascular laser first, then a pigment-specific laser, followed by resurfacing, and augmentation with filler if needed.”

Red scars generally fade with time, but that can take several months to more than a year. “If you use a laser, that can speed up the recovery,” said Dr. Ortiz, who is the vice president of the American Society for Laser Medicine and Surgery. “A vascular laser will work, such as KTP, or intense pulsed light. Studies favor a low fluence and a short pulse duration. Pulsed dye laser (PDL) penetrates deeper than KTP, so theoretically you get a bit of collagen remodeling because it can increase TGF-beta [transforming growth factor–beta], so theoretically, PDL is a little bit better than KTP for red scars, but both will work.”

In a comparative study, researchers used purpuric and nonpurpuric parameters to treat surgical scars but found no significant differences between the two treatment settings. “I tend to stick to short pulse duration and low fluence settings,” said Dr. Ortiz, who was not affiliated with the study.

A separate, single-blinded, split scar study, which compared the efficacy of KTP to 595 nm PDL in reduction of erythema in surgical scars, found no significant difference between the two approaches. A review of available therapeutic lasers for acne scarring found that the thermal energy delivered by KTP extends only to the papillary dermis, making it useful for postinflammatory erythema without significant effects on collagen remodeling.
 

Hyperpigmentation

Use of concomitant bleaching cream can also help as a preventive strategy for hyperpigmentation. But one study of 100 patients found that pretreatment with a bleaching regimen prior to undergoing CO₂ laser resurfacing made no significant difference in hyperpigmentation compared with those who received no pretreatment regimen.

When Dr. Ortiz is concerned about hyperpigmentation after laser treatment, she prescribes post-treatment tranexamic acid 325 mg twice daily for 6 months or longer. “I don’t do any kind of workup or labs, but I do not prescribe it if a patient has increased risk of clotting,” she said. Those at increased risk include smokers, those on birth control pills, those on hormonal supplementation, those with a current malignancy, and those with a history of a cerebrovascular accident or deep vein thrombosis.

Hypopigmented, atrophic scars

In Dr. Ortiz’s clinical experience, hypopigmented scars respond well to treatment with the 1550 nonablative laser. “The idea is that you’re removing some of the scarred collagen and it allows the melanocytes to migrate in and repigment,” she said. Following laser treatment, consider applying topical bimatoprost 0.03% twice daily for at least 3 months to optimize results, she added.

For atrophic scars, options include subcision, laser treatment, radiofrequency microneedling, fillers, or biostimulators. “I caution against using permanent fillers because there is a higher risk of granuloma formation,” Dr. Ortiz said. “I tend to use hyaluronic acid fillers, which have a low G prime. I inject superficially.”

She shared a technique she learned from Mathew Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. It entails spreading the skin with one’s fingers for a scar, especially an acne scar. “If it improves when you spread the skin, then you know it’s amenable to laser treatment,” Dr. Ortiz said. “But if it doesn’t improve when you spread the skin, it probably needs a little subcision. Insert an 18- or 20-gauge tribeveled hypodermic needle or an 18-gauge Nokor under the scar to sever the fibrous components that anchor the scar. This can take more than one treatment. I’ll often do this immediately before resurfacing.”

For hypertrophic scars, consider laser-assisted drug delivery, which creates vertical channels that assist the delivery of topically applied drugs into the skin. “You never want to use something that isn’t meant to be injected into the skin because you can get a granulomatous reaction,” she warned. “I often use topical triamcinolone acetonide, 5-FU, or poly-l-lactic acid.”

Dr. Ortiz noted that botulinum toxin type A may be helpful for scars, despite the paucity of evidence regarding specific mechanisms of action. “There is some thought that it can modulate TGF-beta,” she said. “It also may modulate collagen deposition. Currently we’re looking into Botox alone for keloid scars. The initial results look just okay.”

Dr. Ortiz disclosed that she has received consulting fees from Alastin, Cutera, and Sciton, and honoraria from BTL and Procter & Gamble. She is also a member of the advisory board for Aerolase, Allergan, Bausch Health, Endo, Galderma, Rodan + Fields, and Sciton, and has received equipment from BTL, Sciton, and SmartGraft.

DENVER – When Arisa E. Ortiz, MD, meets with patients who seek treatment options for scars, the first thing she explains is that she can’t erase them.

“It’s important to manage expectations,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual meeting of the American Society for Dermatologic Surgery. “I tell them I can improve their scar and make it look less noticeable, but I can’t make it look like normal skin. It’s going to require multiple treatments. It’s not a one-time thing; it’s going to take several months to see the full benefit. And, it’s an investment of time and money.”

Nonablative, ablative, and fractional resurfacing stimulates dermal fibroblasts to replace lost collagen and elastin. Traditional lasers offer impressive clinical results for scars but are associated with significant preprocedural discomfort, prolonged recovery, and a significant risk of side effects, Dr. Ortiz said, while nonablative lasers are more tolerable with shorter recovery times.

Multiple sessions are required, and results are often less clinically impressive. “It’s often difficult for patients to have a lot of downtime with each treatment so often I prefer to use the nonablative laser, especially for acne scarring,” she said.

Mounting evidence suggests that the sooner scars are treated after they are formed, the better. That may not be feasible for patients with a long history of acne scars, but for surgical scars, Dr. Ortiz prefers to start treatment on the day of suture removal. “Whenever I do that, I always get better results,” she said.

Outcomes may also improve by combining different treatment options, but the type of scar drives the type of modality to consider. There are red scars from postinflammatory erythema, hyperpigmented scars, hypopigmented scars, atrophic scars, hypertrophic scars, spread scars, pin cushion scars, and keloid scars, “which are the most difficult to treat,” she said. “When I’m using a combination approach, I start with the redness component of the scar, because you don’t want to exacerbate nonspecific erythema, or it’ll be difficult to see where the redness is. So, I always use vascular laser first, then a pigment-specific laser, followed by resurfacing, and augmentation with filler if needed.”

Red scars generally fade with time, but that can take several months to more than a year. “If you use a laser, that can speed up the recovery,” said Dr. Ortiz, who is the vice president of the American Society for Laser Medicine and Surgery. “A vascular laser will work, such as KTP, or intense pulsed light. Studies favor a low fluence and a short pulse duration. Pulsed dye laser (PDL) penetrates deeper than KTP, so theoretically you get a bit of collagen remodeling because it can increase TGF-beta [transforming growth factor–beta], so theoretically, PDL is a little bit better than KTP for red scars, but both will work.”

In a comparative study, researchers used purpuric and nonpurpuric parameters to treat surgical scars but found no significant differences between the two treatment settings. “I tend to stick to short pulse duration and low fluence settings,” said Dr. Ortiz, who was not affiliated with the study.

A separate, single-blinded, split scar study, which compared the efficacy of KTP to 595 nm PDL in reduction of erythema in surgical scars, found no significant difference between the two approaches. A review of available therapeutic lasers for acne scarring found that the thermal energy delivered by KTP extends only to the papillary dermis, making it useful for postinflammatory erythema without significant effects on collagen remodeling.
 

Hyperpigmentation

Use of concomitant bleaching cream can also help as a preventive strategy for hyperpigmentation. But one study of 100 patients found that pretreatment with a bleaching regimen prior to undergoing CO₂ laser resurfacing made no significant difference in hyperpigmentation compared with those who received no pretreatment regimen.

When Dr. Ortiz is concerned about hyperpigmentation after laser treatment, she prescribes post-treatment tranexamic acid 325 mg twice daily for 6 months or longer. “I don’t do any kind of workup or labs, but I do not prescribe it if a patient has increased risk of clotting,” she said. Those at increased risk include smokers, those on birth control pills, those on hormonal supplementation, those with a current malignancy, and those with a history of a cerebrovascular accident or deep vein thrombosis.

Hypopigmented, atrophic scars

In Dr. Ortiz’s clinical experience, hypopigmented scars respond well to treatment with the 1550 nonablative laser. “The idea is that you’re removing some of the scarred collagen and it allows the melanocytes to migrate in and repigment,” she said. Following laser treatment, consider applying topical bimatoprost 0.03% twice daily for at least 3 months to optimize results, she added.

For atrophic scars, options include subcision, laser treatment, radiofrequency microneedling, fillers, or biostimulators. “I caution against using permanent fillers because there is a higher risk of granuloma formation,” Dr. Ortiz said. “I tend to use hyaluronic acid fillers, which have a low G prime. I inject superficially.”

She shared a technique she learned from Mathew Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. It entails spreading the skin with one’s fingers for a scar, especially an acne scar. “If it improves when you spread the skin, then you know it’s amenable to laser treatment,” Dr. Ortiz said. “But if it doesn’t improve when you spread the skin, it probably needs a little subcision. Insert an 18- or 20-gauge tribeveled hypodermic needle or an 18-gauge Nokor under the scar to sever the fibrous components that anchor the scar. This can take more than one treatment. I’ll often do this immediately before resurfacing.”

For hypertrophic scars, consider laser-assisted drug delivery, which creates vertical channels that assist the delivery of topically applied drugs into the skin. “You never want to use something that isn’t meant to be injected into the skin because you can get a granulomatous reaction,” she warned. “I often use topical triamcinolone acetonide, 5-FU, or poly-l-lactic acid.”

Dr. Ortiz noted that botulinum toxin type A may be helpful for scars, despite the paucity of evidence regarding specific mechanisms of action. “There is some thought that it can modulate TGF-beta,” she said. “It also may modulate collagen deposition. Currently we’re looking into Botox alone for keloid scars. The initial results look just okay.”

Dr. Ortiz disclosed that she has received consulting fees from Alastin, Cutera, and Sciton, and honoraria from BTL and Procter & Gamble. She is also a member of the advisory board for Aerolase, Allergan, Bausch Health, Endo, Galderma, Rodan + Fields, and Sciton, and has received equipment from BTL, Sciton, and SmartGraft.

DENVER – When Arisa E. Ortiz, MD, meets with patients who seek treatment options for scars, the first thing she explains is that she can’t erase them.

“It’s important to manage expectations,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual meeting of the American Society for Dermatologic Surgery. “I tell them I can improve their scar and make it look less noticeable, but I can’t make it look like normal skin. It’s going to require multiple treatments. It’s not a one-time thing; it’s going to take several months to see the full benefit. And, it’s an investment of time and money.”

Nonablative, ablative, and fractional resurfacing stimulates dermal fibroblasts to replace lost collagen and elastin. Traditional lasers offer impressive clinical results for scars but are associated with significant preprocedural discomfort, prolonged recovery, and a significant risk of side effects, Dr. Ortiz said, while nonablative lasers are more tolerable with shorter recovery times.

Multiple sessions are required, and results are often less clinically impressive. “It’s often difficult for patients to have a lot of downtime with each treatment so often I prefer to use the nonablative laser, especially for acne scarring,” she said.

Mounting evidence suggests that the sooner scars are treated after they are formed, the better. That may not be feasible for patients with a long history of acne scars, but for surgical scars, Dr. Ortiz prefers to start treatment on the day of suture removal. “Whenever I do that, I always get better results,” she said.

Outcomes may also improve by combining different treatment options, but the type of scar drives the type of modality to consider. There are red scars from postinflammatory erythema, hyperpigmented scars, hypopigmented scars, atrophic scars, hypertrophic scars, spread scars, pin cushion scars, and keloid scars, “which are the most difficult to treat,” she said. “When I’m using a combination approach, I start with the redness component of the scar, because you don’t want to exacerbate nonspecific erythema, or it’ll be difficult to see where the redness is. So, I always use vascular laser first, then a pigment-specific laser, followed by resurfacing, and augmentation with filler if needed.”

Red scars generally fade with time, but that can take several months to more than a year. “If you use a laser, that can speed up the recovery,” said Dr. Ortiz, who is the vice president of the American Society for Laser Medicine and Surgery. “A vascular laser will work, such as KTP, or intense pulsed light. Studies favor a low fluence and a short pulse duration. Pulsed dye laser (PDL) penetrates deeper than KTP, so theoretically you get a bit of collagen remodeling because it can increase TGF-beta [transforming growth factor–beta], so theoretically, PDL is a little bit better than KTP for red scars, but both will work.”

In a comparative study, researchers used purpuric and nonpurpuric parameters to treat surgical scars but found no significant differences between the two treatment settings. “I tend to stick to short pulse duration and low fluence settings,” said Dr. Ortiz, who was not affiliated with the study.

A separate, single-blinded, split scar study, which compared the efficacy of KTP to 595 nm PDL in reduction of erythema in surgical scars, found no significant difference between the two approaches. A review of available therapeutic lasers for acne scarring found that the thermal energy delivered by KTP extends only to the papillary dermis, making it useful for postinflammatory erythema without significant effects on collagen remodeling.
 

Hyperpigmentation

Use of concomitant bleaching cream can also help as a preventive strategy for hyperpigmentation. But one study of 100 patients found that pretreatment with a bleaching regimen prior to undergoing CO₂ laser resurfacing made no significant difference in hyperpigmentation compared with those who received no pretreatment regimen.

When Dr. Ortiz is concerned about hyperpigmentation after laser treatment, she prescribes post-treatment tranexamic acid 325 mg twice daily for 6 months or longer. “I don’t do any kind of workup or labs, but I do not prescribe it if a patient has increased risk of clotting,” she said. Those at increased risk include smokers, those on birth control pills, those on hormonal supplementation, those with a current malignancy, and those with a history of a cerebrovascular accident or deep vein thrombosis.

Hypopigmented, atrophic scars

In Dr. Ortiz’s clinical experience, hypopigmented scars respond well to treatment with the 1550 nonablative laser. “The idea is that you’re removing some of the scarred collagen and it allows the melanocytes to migrate in and repigment,” she said. Following laser treatment, consider applying topical bimatoprost 0.03% twice daily for at least 3 months to optimize results, she added.

For atrophic scars, options include subcision, laser treatment, radiofrequency microneedling, fillers, or biostimulators. “I caution against using permanent fillers because there is a higher risk of granuloma formation,” Dr. Ortiz said. “I tend to use hyaluronic acid fillers, which have a low G prime. I inject superficially.”

She shared a technique she learned from Mathew Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. It entails spreading the skin with one’s fingers for a scar, especially an acne scar. “If it improves when you spread the skin, then you know it’s amenable to laser treatment,” Dr. Ortiz said. “But if it doesn’t improve when you spread the skin, it probably needs a little subcision. Insert an 18- or 20-gauge tribeveled hypodermic needle or an 18-gauge Nokor under the scar to sever the fibrous components that anchor the scar. This can take more than one treatment. I’ll often do this immediately before resurfacing.”

For hypertrophic scars, consider laser-assisted drug delivery, which creates vertical channels that assist the delivery of topically applied drugs into the skin. “You never want to use something that isn’t meant to be injected into the skin because you can get a granulomatous reaction,” she warned. “I often use topical triamcinolone acetonide, 5-FU, or poly-l-lactic acid.”

Dr. Ortiz noted that botulinum toxin type A may be helpful for scars, despite the paucity of evidence regarding specific mechanisms of action. “There is some thought that it can modulate TGF-beta,” she said. “It also may modulate collagen deposition. Currently we’re looking into Botox alone for keloid scars. The initial results look just okay.”

Dr. Ortiz disclosed that she has received consulting fees from Alastin, Cutera, and Sciton, and honoraria from BTL and Procter & Gamble. She is also a member of the advisory board for Aerolase, Allergan, Bausch Health, Endo, Galderma, Rodan + Fields, and Sciton, and has received equipment from BTL, Sciton, and SmartGraft.

DENVER – Patients who continued to undergo routine minimally invasive cosmetic procedures during the COVID-19 Omicron outbreak in 2021 were happier and more satisfied with life overall compared with the general population, according to a study of 42 individuals. However, these treatments did not improve their baseline happiness or life satisfaction scores at follow-up.

Those are key findings from the study that lead author Rishi Chopra, MD, MS, presented during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“These are interesting and surprising results,” said Dr. Chopra, a dermatologist and laser and cosmetic dermatologic surgery fellow at Harvard Medical School and Massachusetts General Hospital in Boston. “Patients are seeking consultations with us with the hope that the treatments we offer may potentially help them feel happier, but are we really delivering on that?”

In a pivotal 2018 study that examined patient motivations for undergoing cosmetic dermatology procedures, investigators found that 67.2% did so to “feel happier and more confident or improve total quality of life”. Moreover, 38.5% cited the desire to “feel happier, better overall, or improve total quality of life” as the key reason for pursuing cosmetic procedures.

Prior published evidence validates this benefit of procedures, as neuromodulators have repeatedly demonstrated to improve mood and depression, including a 2020 randomized, single-blind crossover study that examined the impact of neuromodulators on mood and appearance during the COVID-19 pandemic. It found that patients who received treatment with neuromodulators prior to the pandemic, stopped during the pandemic, and restarted again, reported increased happiness, self-satisfaction with appearance, and overall treatment satisfaction.

“However, studies evaluating the effect of filler on happiness have failed to demonstrate an impact,” Dr. Chopra said. “Thus, the jury is still out.”

Study evaluated 42 patients

In what he said is the first study of its kind, he and his colleagues evaluated the impact of minimally invasive cosmetic procedures on the happiness of 42 treatment non-naive patients (those who regularly undergo cosmetic procedures) with a mean age of 47 years who were surveyed in November and December of 2021 during the COVID-19 Omicron subvariant outbreak at the cosmetic dermatology practices of Sabrina G. Fabi, MD, in San Diego, and Nicole Kanaris, MBBCh, in Johannesburg, South Africa.

“On average, these patients were undergoing six treatments per year during four visits per year, so these were frequent flyers,” Dr. Chopra said. “We set out to assess: Are patients who seek cosmetic procedures happy at baseline? And, do cosmetic procedures make us happier or more satisfied with life?”

Prior to treatment, patients completed the Subjective Happiness Scale (SHS) and Satisfaction With Life Scale (SWLS). Three weeks later, patients completed the SHS, SWLS, the Global Aesthetic Improvement Scale (GAIS) and a 5-point satisfaction score. The researchers used paired and unpaired t-tests, independent sample t-tests, and Spearman rank correlations to conduct statistical analyses.

The baseline SHS score of study participants was an average of 5.87, which Dr. Chopra said is higher than the worldwide population range between 4.57 and 5.33, and 5.05 in the U.S. population. “The patients in our study were very happy to begin with,” an important point to consider, he said. Following their treatments, respondents felt “improved” or “much improved” on the GAIS (a mean score of 3.64) and “somewhat satisfied” or “very satisfied” based on the SWLS (a mean score of 4.4). “So overall, they viewed their treatments as a success,” Dr. Chopra said.

In terms of happiness, however, the researchers observed no significant differences between pre- and posttreatment scores on the SHS (a mean of 5.87 vs. 6.61, respectively; P = .634) nor on the SWLS (a mean of 29.62 vs. 29.1; P = .709). On stratified analysis, no significant differences in the SHS, SWLS, and the GAIS were observed when the researchers accounted for the aggressiveness of the procedure, the number of treatments, the number of sites treated, the type of treatment, and whether the respondents were happier or sadder at baseline. “Surprisingly, this had no effect whatsoever on happiness,” he said. “Not only that, these factors didn’t improve a patient’s perception of the efficacy or satisfaction with a treatment either.”

“In addition, only two locations were surveyed, so the results could have location bias. I think it would be a great idea to replicate this survey of experienced cosmetic treatment patients with many locations and to include survey responses based on the procedure that was done. That said, it is interesting that overall, investigator satisfaction did not correlate with patient happiness from the treatments.”

Dr. Chopra reported having no financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Patients who continued to undergo routine minimally invasive cosmetic procedures during the COVID-19 Omicron outbreak in 2021 were happier and more satisfied with life overall compared with the general population, according to a study of 42 individuals. However, these treatments did not improve their baseline happiness or life satisfaction scores at follow-up.

Those are key findings from the study that lead author Rishi Chopra, MD, MS, presented during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“These are interesting and surprising results,” said Dr. Chopra, a dermatologist and laser and cosmetic dermatologic surgery fellow at Harvard Medical School and Massachusetts General Hospital in Boston. “Patients are seeking consultations with us with the hope that the treatments we offer may potentially help them feel happier, but are we really delivering on that?”

In a pivotal 2018 study that examined patient motivations for undergoing cosmetic dermatology procedures, investigators found that 67.2% did so to “feel happier and more confident or improve total quality of life”. Moreover, 38.5% cited the desire to “feel happier, better overall, or improve total quality of life” as the key reason for pursuing cosmetic procedures.

Prior published evidence validates this benefit of procedures, as neuromodulators have repeatedly demonstrated to improve mood and depression, including a 2020 randomized, single-blind crossover study that examined the impact of neuromodulators on mood and appearance during the COVID-19 pandemic. It found that patients who received treatment with neuromodulators prior to the pandemic, stopped during the pandemic, and restarted again, reported increased happiness, self-satisfaction with appearance, and overall treatment satisfaction.

“However, studies evaluating the effect of filler on happiness have failed to demonstrate an impact,” Dr. Chopra said. “Thus, the jury is still out.”

Study evaluated 42 patients

In what he said is the first study of its kind, he and his colleagues evaluated the impact of minimally invasive cosmetic procedures on the happiness of 42 treatment non-naive patients (those who regularly undergo cosmetic procedures) with a mean age of 47 years who were surveyed in November and December of 2021 during the COVID-19 Omicron subvariant outbreak at the cosmetic dermatology practices of Sabrina G. Fabi, MD, in San Diego, and Nicole Kanaris, MBBCh, in Johannesburg, South Africa.

“On average, these patients were undergoing six treatments per year during four visits per year, so these were frequent flyers,” Dr. Chopra said. “We set out to assess: Are patients who seek cosmetic procedures happy at baseline? And, do cosmetic procedures make us happier or more satisfied with life?”

Prior to treatment, patients completed the Subjective Happiness Scale (SHS) and Satisfaction With Life Scale (SWLS). Three weeks later, patients completed the SHS, SWLS, the Global Aesthetic Improvement Scale (GAIS) and a 5-point satisfaction score. The researchers used paired and unpaired t-tests, independent sample t-tests, and Spearman rank correlations to conduct statistical analyses.

The baseline SHS score of study participants was an average of 5.87, which Dr. Chopra said is higher than the worldwide population range between 4.57 and 5.33, and 5.05 in the U.S. population. “The patients in our study were very happy to begin with,” an important point to consider, he said. Following their treatments, respondents felt “improved” or “much improved” on the GAIS (a mean score of 3.64) and “somewhat satisfied” or “very satisfied” based on the SWLS (a mean score of 4.4). “So overall, they viewed their treatments as a success,” Dr. Chopra said.

In terms of happiness, however, the researchers observed no significant differences between pre- and posttreatment scores on the SHS (a mean of 5.87 vs. 6.61, respectively; P = .634) nor on the SWLS (a mean of 29.62 vs. 29.1; P = .709). On stratified analysis, no significant differences in the SHS, SWLS, and the GAIS were observed when the researchers accounted for the aggressiveness of the procedure, the number of treatments, the number of sites treated, the type of treatment, and whether the respondents were happier or sadder at baseline. “Surprisingly, this had no effect whatsoever on happiness,” he said. “Not only that, these factors didn’t improve a patient’s perception of the efficacy or satisfaction with a treatment either.”

“In addition, only two locations were surveyed, so the results could have location bias. I think it would be a great idea to replicate this survey of experienced cosmetic treatment patients with many locations and to include survey responses based on the procedure that was done. That said, it is interesting that overall, investigator satisfaction did not correlate with patient happiness from the treatments.”

Dr. Chopra reported having no financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Patients who continued to undergo routine minimally invasive cosmetic procedures during the COVID-19 Omicron outbreak in 2021 were happier and more satisfied with life overall compared with the general population, according to a study of 42 individuals. However, these treatments did not improve their baseline happiness or life satisfaction scores at follow-up.

Those are key findings from the study that lead author Rishi Chopra, MD, MS, presented during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“These are interesting and surprising results,” said Dr. Chopra, a dermatologist and laser and cosmetic dermatologic surgery fellow at Harvard Medical School and Massachusetts General Hospital in Boston. “Patients are seeking consultations with us with the hope that the treatments we offer may potentially help them feel happier, but are we really delivering on that?”

In a pivotal 2018 study that examined patient motivations for undergoing cosmetic dermatology procedures, investigators found that 67.2% did so to “feel happier and more confident or improve total quality of life”. Moreover, 38.5% cited the desire to “feel happier, better overall, or improve total quality of life” as the key reason for pursuing cosmetic procedures.

Prior published evidence validates this benefit of procedures, as neuromodulators have repeatedly demonstrated to improve mood and depression, including a 2020 randomized, single-blind crossover study that examined the impact of neuromodulators on mood and appearance during the COVID-19 pandemic. It found that patients who received treatment with neuromodulators prior to the pandemic, stopped during the pandemic, and restarted again, reported increased happiness, self-satisfaction with appearance, and overall treatment satisfaction.

“However, studies evaluating the effect of filler on happiness have failed to demonstrate an impact,” Dr. Chopra said. “Thus, the jury is still out.”

Study evaluated 42 patients

In what he said is the first study of its kind, he and his colleagues evaluated the impact of minimally invasive cosmetic procedures on the happiness of 42 treatment non-naive patients (those who regularly undergo cosmetic procedures) with a mean age of 47 years who were surveyed in November and December of 2021 during the COVID-19 Omicron subvariant outbreak at the cosmetic dermatology practices of Sabrina G. Fabi, MD, in San Diego, and Nicole Kanaris, MBBCh, in Johannesburg, South Africa.

“On average, these patients were undergoing six treatments per year during four visits per year, so these were frequent flyers,” Dr. Chopra said. “We set out to assess: Are patients who seek cosmetic procedures happy at baseline? And, do cosmetic procedures make us happier or more satisfied with life?”

Prior to treatment, patients completed the Subjective Happiness Scale (SHS) and Satisfaction With Life Scale (SWLS). Three weeks later, patients completed the SHS, SWLS, the Global Aesthetic Improvement Scale (GAIS) and a 5-point satisfaction score. The researchers used paired and unpaired t-tests, independent sample t-tests, and Spearman rank correlations to conduct statistical analyses.

The baseline SHS score of study participants was an average of 5.87, which Dr. Chopra said is higher than the worldwide population range between 4.57 and 5.33, and 5.05 in the U.S. population. “The patients in our study were very happy to begin with,” an important point to consider, he said. Following their treatments, respondents felt “improved” or “much improved” on the GAIS (a mean score of 3.64) and “somewhat satisfied” or “very satisfied” based on the SWLS (a mean score of 4.4). “So overall, they viewed their treatments as a success,” Dr. Chopra said.

In terms of happiness, however, the researchers observed no significant differences between pre- and posttreatment scores on the SHS (a mean of 5.87 vs. 6.61, respectively; P = .634) nor on the SWLS (a mean of 29.62 vs. 29.1; P = .709). On stratified analysis, no significant differences in the SHS, SWLS, and the GAIS were observed when the researchers accounted for the aggressiveness of the procedure, the number of treatments, the number of sites treated, the type of treatment, and whether the respondents were happier or sadder at baseline. “Surprisingly, this had no effect whatsoever on happiness,” he said. “Not only that, these factors didn’t improve a patient’s perception of the efficacy or satisfaction with a treatment either.”

“In addition, only two locations were surveyed, so the results could have location bias. I think it would be a great idea to replicate this survey of experienced cosmetic treatment patients with many locations and to include survey responses based on the procedure that was done. That said, it is interesting that overall, investigator satisfaction did not correlate with patient happiness from the treatments.”

Dr. Chopra reported having no financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

CHARLOTTE, N.C.– Performing high-quality index colonoscopies may pay off later in your patients’ reduced risk for advanced neoplasia, investigators report.

A study of registry data on more than 2,200 patients who had an index colonoscopy showing no evidence of neoplasia found that, on repeat colonoscopy 10 years later, the absolute risk for advanced neoplasia outcomes was lower for those with a high-quality index exam, compared with those who had a lesser-quality index colonoscopy.

Neil Osterweil/MDedge News

The adjusted odds ratio for patients who underwent high-quality index exams was 0.59%, reported Joseph Anderson, MD, from the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“These data demonstrate that high-quality index colonoscopy provides better protection from interval lesions than low-quality exams with no polyps detected at that index exam,” he said in an oral abstract presentation at the annual meeting of the American College of Gastroenterology.

“These data support the importance of high-quality index exams in the prevention of interval colorectal cancer, and support the 10-year interval for normal exams,” Dr. Anderson added.

He recommended that endoscopists focus on the quality of their exams by using adequate scope withdrawal time – 8-10 minutes – to ensure optimal adenoma detection, and by ensuring the use of optimal bowel preparation in their practices.

Registry study

Dr. Anderson and colleagues studied how the quality of index colonoscopies could affect the risk of advanced outcomes in low-risk patients at the 10-year or later follow-up. They used records from the New Hampshire Colonoscopy Registry, which includes data from 2004 to the present on more than 250,000 exams performed by more than 150 endoscopists in more than 30 Granite State practices.

The investigators also looked at data on patients with less than 5 years of follow-up, and those with follow-up from 5 to less than 10 years.

The study sample included patients with no adenoma or significant serrated polyps on their index exams who had at least one follow-up exam 12 months or more after the index exams. Patients with inflammatory bowel disease or familial colon cancer syndromes were excluded.

They defined a high-quality colonoscopy as an exam complete to cecum, with adequate bowel preparation, and performed by an endoscopist with an adenoma detection rate of 25 or higher.

The adenoma detection rate is calculated as the number of screening colonoscopies with at least one adenoma divided by the total number of screening colonoscopies.

The definition of advanced outcomes included advanced adenomas, colorectal cancer, and/or large serrated polyps (1 cm or greater).

Of the 14,011 patients in the sample, 2,283 had a follow-up exam at 10 years. The absolute risk for advanced outcomes among patients who had a high quality index exam was 4.0% vs. 6.7% for those with lower quality exams.

Among patients with low-quality index exams – but not patients with high quality exams – there was a statistically significant increase in the absolute risk for advanced outcomes at all time periods, from 5.1% in the less than 5-year follow-up group, to 6.7% in the 10-years or more follow-up group.

Patients with initial high-quality exams also had a lower risk for postcolonoscopy colorectal cancer, compared with patients who had low-quality index exams: 0.4% vs. 0.8%. This difference translated into an adjusted hazard ratio for colorectal cancer after a high-quality exam of 0.53.
 

It’s getting better all the time

In an interview, Daniel J. Pambianco, MD, FACG from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that Dr. Anderson and colleagues highlighted the importance of the quality of the bowel prep and the quality of the examination itself.

He noted that the use of devices such as colonoscopy caps can help further improve adenoma detection rates and pointed to up-and-coming developments such as the use of artificial intelligence algorithms to aid human endoscopists.

Dr. Pambianco comoderated the session where the data were presented.

The investigators did not report a study funding source. Dr. Anderson and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C.– Performing high-quality index colonoscopies may pay off later in your patients’ reduced risk for advanced neoplasia, investigators report.

A study of registry data on more than 2,200 patients who had an index colonoscopy showing no evidence of neoplasia found that, on repeat colonoscopy 10 years later, the absolute risk for advanced neoplasia outcomes was lower for those with a high-quality index exam, compared with those who had a lesser-quality index colonoscopy.

Neil Osterweil/MDedge News

The adjusted odds ratio for patients who underwent high-quality index exams was 0.59%, reported Joseph Anderson, MD, from the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“These data demonstrate that high-quality index colonoscopy provides better protection from interval lesions than low-quality exams with no polyps detected at that index exam,” he said in an oral abstract presentation at the annual meeting of the American College of Gastroenterology.

“These data support the importance of high-quality index exams in the prevention of interval colorectal cancer, and support the 10-year interval for normal exams,” Dr. Anderson added.

He recommended that endoscopists focus on the quality of their exams by using adequate scope withdrawal time – 8-10 minutes – to ensure optimal adenoma detection, and by ensuring the use of optimal bowel preparation in their practices.

Registry study

Dr. Anderson and colleagues studied how the quality of index colonoscopies could affect the risk of advanced outcomes in low-risk patients at the 10-year or later follow-up. They used records from the New Hampshire Colonoscopy Registry, which includes data from 2004 to the present on more than 250,000 exams performed by more than 150 endoscopists in more than 30 Granite State practices.

The investigators also looked at data on patients with less than 5 years of follow-up, and those with follow-up from 5 to less than 10 years.

The study sample included patients with no adenoma or significant serrated polyps on their index exams who had at least one follow-up exam 12 months or more after the index exams. Patients with inflammatory bowel disease or familial colon cancer syndromes were excluded.

They defined a high-quality colonoscopy as an exam complete to cecum, with adequate bowel preparation, and performed by an endoscopist with an adenoma detection rate of 25 or higher.

The adenoma detection rate is calculated as the number of screening colonoscopies with at least one adenoma divided by the total number of screening colonoscopies.

The definition of advanced outcomes included advanced adenomas, colorectal cancer, and/or large serrated polyps (1 cm or greater).

Of the 14,011 patients in the sample, 2,283 had a follow-up exam at 10 years. The absolute risk for advanced outcomes among patients who had a high quality index exam was 4.0% vs. 6.7% for those with lower quality exams.

Among patients with low-quality index exams – but not patients with high quality exams – there was a statistically significant increase in the absolute risk for advanced outcomes at all time periods, from 5.1% in the less than 5-year follow-up group, to 6.7% in the 10-years or more follow-up group.

Patients with initial high-quality exams also had a lower risk for postcolonoscopy colorectal cancer, compared with patients who had low-quality index exams: 0.4% vs. 0.8%. This difference translated into an adjusted hazard ratio for colorectal cancer after a high-quality exam of 0.53.
 

It’s getting better all the time

In an interview, Daniel J. Pambianco, MD, FACG from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that Dr. Anderson and colleagues highlighted the importance of the quality of the bowel prep and the quality of the examination itself.

He noted that the use of devices such as colonoscopy caps can help further improve adenoma detection rates and pointed to up-and-coming developments such as the use of artificial intelligence algorithms to aid human endoscopists.

Dr. Pambianco comoderated the session where the data were presented.

The investigators did not report a study funding source. Dr. Anderson and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C.– Performing high-quality index colonoscopies may pay off later in your patients’ reduced risk for advanced neoplasia, investigators report.

A study of registry data on more than 2,200 patients who had an index colonoscopy showing no evidence of neoplasia found that, on repeat colonoscopy 10 years later, the absolute risk for advanced neoplasia outcomes was lower for those with a high-quality index exam, compared with those who had a lesser-quality index colonoscopy.

Neil Osterweil/MDedge News

The adjusted odds ratio for patients who underwent high-quality index exams was 0.59%, reported Joseph Anderson, MD, from the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“These data demonstrate that high-quality index colonoscopy provides better protection from interval lesions than low-quality exams with no polyps detected at that index exam,” he said in an oral abstract presentation at the annual meeting of the American College of Gastroenterology.

“These data support the importance of high-quality index exams in the prevention of interval colorectal cancer, and support the 10-year interval for normal exams,” Dr. Anderson added.

He recommended that endoscopists focus on the quality of their exams by using adequate scope withdrawal time – 8-10 minutes – to ensure optimal adenoma detection, and by ensuring the use of optimal bowel preparation in their practices.

Registry study

Dr. Anderson and colleagues studied how the quality of index colonoscopies could affect the risk of advanced outcomes in low-risk patients at the 10-year or later follow-up. They used records from the New Hampshire Colonoscopy Registry, which includes data from 2004 to the present on more than 250,000 exams performed by more than 150 endoscopists in more than 30 Granite State practices.

The investigators also looked at data on patients with less than 5 years of follow-up, and those with follow-up from 5 to less than 10 years.

The study sample included patients with no adenoma or significant serrated polyps on their index exams who had at least one follow-up exam 12 months or more after the index exams. Patients with inflammatory bowel disease or familial colon cancer syndromes were excluded.

They defined a high-quality colonoscopy as an exam complete to cecum, with adequate bowel preparation, and performed by an endoscopist with an adenoma detection rate of 25 or higher.

The adenoma detection rate is calculated as the number of screening colonoscopies with at least one adenoma divided by the total number of screening colonoscopies.

The definition of advanced outcomes included advanced adenomas, colorectal cancer, and/or large serrated polyps (1 cm or greater).

Of the 14,011 patients in the sample, 2,283 had a follow-up exam at 10 years. The absolute risk for advanced outcomes among patients who had a high quality index exam was 4.0% vs. 6.7% for those with lower quality exams.

Among patients with low-quality index exams – but not patients with high quality exams – there was a statistically significant increase in the absolute risk for advanced outcomes at all time periods, from 5.1% in the less than 5-year follow-up group, to 6.7% in the 10-years or more follow-up group.

Patients with initial high-quality exams also had a lower risk for postcolonoscopy colorectal cancer, compared with patients who had low-quality index exams: 0.4% vs. 0.8%. This difference translated into an adjusted hazard ratio for colorectal cancer after a high-quality exam of 0.53.
 

It’s getting better all the time

In an interview, Daniel J. Pambianco, MD, FACG from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that Dr. Anderson and colleagues highlighted the importance of the quality of the bowel prep and the quality of the examination itself.

He noted that the use of devices such as colonoscopy caps can help further improve adenoma detection rates and pointed to up-and-coming developments such as the use of artificial intelligence algorithms to aid human endoscopists.

Dr. Pambianco comoderated the session where the data were presented.

The investigators did not report a study funding source. Dr. Anderson and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C. – In a real-world setting, a 1-liter polyethylene glycol and ascorbic acid combination produced a high level of adequate or better bowel cleansing for colonoscopy.

Among more than 13,000 patients who used the combination, abbreviated as 1L PEG+ASC (Plenvu), the overall rate of adequate quality bowel prep was 89.3%, reported Cátia Arieira, MD, from the Hospital da Senhora da Oliveira in Guimarães, Portugal.

The rate of adequate prep was significantly higher with a split-dose regimen (evening-morning) than with a same-day regimen, at 94.7% versus 86.7%, respectively.

“Results from this large study confirm the high cleansing effectiveness and good tolerability of 1 liter of polyethylene glycol and ascorbic acid in real-world settings,” she said in an oral abstract session during the annual meeting of the American College of Gastroenterology.

Designed for tolerability

The 1L PEG+ASC regimen is intended to make precolonoscopy bowel prep a little easier both to take, by reducing the volume of liquid patients need to ingest, and to reduce indigestion with two asymmetric doses, with the second dose having a high ascorbate content.

The 1-liter regimen has been shown to be safe and effective both in clinical trials and in smaller practice-based studies, Dr. Arieira said.

To see how well 1L PEG+ASC performs on a larger scale, the investigators conducted a retrospective observational study of patients underwent a colonoscopy from June 2019 to September 2021 at 12 centers in Spain and Portugal.

The sample included patients who had either a screening, diagnostic, or surveillance colonoscopy and used 1L PEG+ASC in either a split or same-day dose.

The investigators used the Boston Bowel Preparation Scale (BBPS) to evaluate the quality of cleansing. They defined an adequate cleansing as a total BBPS score of 6 or greater, with all segmental scores 2 or greater, and a high-quality cleansing as segmental scores of 3.

They enrolled a total of 13,169 patients, 6,406 men and 6,763 women. The same-day regimen was used by two-thirds of patients, and the split-dose regimen by one-third.

In all, 41.9% of procedures were for screening, 29.4% for diagnosis, 26.2% for surveillance, and 2.6% for other, unspecified reasons.

Results

As noted, the overall rate of adequate prep was 89.3%, with rates of 94.7% and 86.7% for the split and same-day doses, respectively.

A breakdown of cleansing by bowel segment showed that, for each segment, the split-dose regimen was numerically superior to the same-day regimen, with rates of 95.6% versus 89.5% for the right colon, 97.1% versus 91.9% for the left colon, and 97.8% versus 93.1% for the transverse colon, respectively.

Mean BBPS scores were significantly better with split dosing, at 8.02 versus 6.96. Higher scores were seen with split-dosing for each colon segment.

The incidence of adverse events was low, at 2.3% overall, 1.4% for same-day dosing, and 3.9% for split dosing, with nausea the most common.

Tolerability is key

Renee L. Williams, MD, MHPE, FACG, from New York University, who moderated the session but was not involved in the study, commented that the more convenient 1L PEG+ASC regimen may be helpful with improving compliance with bowel prep in underserved populations.

“My population of patients is very different from the one in this study,” she said in an interview. “Normally, if you’re looking at people who are not prepped, at least in the United States, people who have a lot of comorbidities, who are underserved, or have insurance uncertainty tend to have a lower level of bowel prep. So I’d be curious to see whether this would work in that population.”

Dr. Williams noted that she prefers split dosing for bowel prep because it offers better tolerability for patients, adding that when her center introduced split-dose prep, the percentage of adequate prep rose from around 60% to more than 90%.

Comoderator John R. Saltzman, MD, FACG, from Harvard Medical School and Brigham & Women’s Hospital, both in Boston, said that while he’s not familiar with this specific bowel prep formulation, “I’m looking for whatever is most palatable to patients and most effective in practice. Still, most of our patients tolerate these 2-liter overnight preps very well.”

The 1L-PEG+ASC regimen may be a suitable option for patients whose colonoscopies are scheduled for later in the day, Dr. Saltzman added.

The study was supported by Norgine and Xolomon Tree. Dr. Arieira, Dr. Williams, and Dr. Saltzman reported no relevant conflicts of interest.

CHARLOTTE, N.C. – In a real-world setting, a 1-liter polyethylene glycol and ascorbic acid combination produced a high level of adequate or better bowel cleansing for colonoscopy.

Among more than 13,000 patients who used the combination, abbreviated as 1L PEG+ASC (Plenvu), the overall rate of adequate quality bowel prep was 89.3%, reported Cátia Arieira, MD, from the Hospital da Senhora da Oliveira in Guimarães, Portugal.

The rate of adequate prep was significantly higher with a split-dose regimen (evening-morning) than with a same-day regimen, at 94.7% versus 86.7%, respectively.

“Results from this large study confirm the high cleansing effectiveness and good tolerability of 1 liter of polyethylene glycol and ascorbic acid in real-world settings,” she said in an oral abstract session during the annual meeting of the American College of Gastroenterology.

Designed for tolerability

The 1L PEG+ASC regimen is intended to make precolonoscopy bowel prep a little easier both to take, by reducing the volume of liquid patients need to ingest, and to reduce indigestion with two asymmetric doses, with the second dose having a high ascorbate content.

The 1-liter regimen has been shown to be safe and effective both in clinical trials and in smaller practice-based studies, Dr. Arieira said.

To see how well 1L PEG+ASC performs on a larger scale, the investigators conducted a retrospective observational study of patients underwent a colonoscopy from June 2019 to September 2021 at 12 centers in Spain and Portugal.

The sample included patients who had either a screening, diagnostic, or surveillance colonoscopy and used 1L PEG+ASC in either a split or same-day dose.

The investigators used the Boston Bowel Preparation Scale (BBPS) to evaluate the quality of cleansing. They defined an adequate cleansing as a total BBPS score of 6 or greater, with all segmental scores 2 or greater, and a high-quality cleansing as segmental scores of 3.

They enrolled a total of 13,169 patients, 6,406 men and 6,763 women. The same-day regimen was used by two-thirds of patients, and the split-dose regimen by one-third.

In all, 41.9% of procedures were for screening, 29.4% for diagnosis, 26.2% for surveillance, and 2.6% for other, unspecified reasons.

Results

As noted, the overall rate of adequate prep was 89.3%, with rates of 94.7% and 86.7% for the split and same-day doses, respectively.

A breakdown of cleansing by bowel segment showed that, for each segment, the split-dose regimen was numerically superior to the same-day regimen, with rates of 95.6% versus 89.5% for the right colon, 97.1% versus 91.9% for the left colon, and 97.8% versus 93.1% for the transverse colon, respectively.

Mean BBPS scores were significantly better with split dosing, at 8.02 versus 6.96. Higher scores were seen with split-dosing for each colon segment.

The incidence of adverse events was low, at 2.3% overall, 1.4% for same-day dosing, and 3.9% for split dosing, with nausea the most common.

Tolerability is key

Renee L. Williams, MD, MHPE, FACG, from New York University, who moderated the session but was not involved in the study, commented that the more convenient 1L PEG+ASC regimen may be helpful with improving compliance with bowel prep in underserved populations.

“My population of patients is very different from the one in this study,” she said in an interview. “Normally, if you’re looking at people who are not prepped, at least in the United States, people who have a lot of comorbidities, who are underserved, or have insurance uncertainty tend to have a lower level of bowel prep. So I’d be curious to see whether this would work in that population.”

Dr. Williams noted that she prefers split dosing for bowel prep because it offers better tolerability for patients, adding that when her center introduced split-dose prep, the percentage of adequate prep rose from around 60% to more than 90%.

Comoderator John R. Saltzman, MD, FACG, from Harvard Medical School and Brigham & Women’s Hospital, both in Boston, said that while he’s not familiar with this specific bowel prep formulation, “I’m looking for whatever is most palatable to patients and most effective in practice. Still, most of our patients tolerate these 2-liter overnight preps very well.”

The 1L-PEG+ASC regimen may be a suitable option for patients whose colonoscopies are scheduled for later in the day, Dr. Saltzman added.

The study was supported by Norgine and Xolomon Tree. Dr. Arieira, Dr. Williams, and Dr. Saltzman reported no relevant conflicts of interest.

CHARLOTTE, N.C. – In a real-world setting, a 1-liter polyethylene glycol and ascorbic acid combination produced a high level of adequate or better bowel cleansing for colonoscopy.

Among more than 13,000 patients who used the combination, abbreviated as 1L PEG+ASC (Plenvu), the overall rate of adequate quality bowel prep was 89.3%, reported Cátia Arieira, MD, from the Hospital da Senhora da Oliveira in Guimarães, Portugal.

The rate of adequate prep was significantly higher with a split-dose regimen (evening-morning) than with a same-day regimen, at 94.7% versus 86.7%, respectively.

“Results from this large study confirm the high cleansing effectiveness and good tolerability of 1 liter of polyethylene glycol and ascorbic acid in real-world settings,” she said in an oral abstract session during the annual meeting of the American College of Gastroenterology.

Designed for tolerability

The 1L PEG+ASC regimen is intended to make precolonoscopy bowel prep a little easier both to take, by reducing the volume of liquid patients need to ingest, and to reduce indigestion with two asymmetric doses, with the second dose having a high ascorbate content.

The 1-liter regimen has been shown to be safe and effective both in clinical trials and in smaller practice-based studies, Dr. Arieira said.

To see how well 1L PEG+ASC performs on a larger scale, the investigators conducted a retrospective observational study of patients underwent a colonoscopy from June 2019 to September 2021 at 12 centers in Spain and Portugal.

The sample included patients who had either a screening, diagnostic, or surveillance colonoscopy and used 1L PEG+ASC in either a split or same-day dose.

The investigators used the Boston Bowel Preparation Scale (BBPS) to evaluate the quality of cleansing. They defined an adequate cleansing as a total BBPS score of 6 or greater, with all segmental scores 2 or greater, and a high-quality cleansing as segmental scores of 3.

They enrolled a total of 13,169 patients, 6,406 men and 6,763 women. The same-day regimen was used by two-thirds of patients, and the split-dose regimen by one-third.

In all, 41.9% of procedures were for screening, 29.4% for diagnosis, 26.2% for surveillance, and 2.6% for other, unspecified reasons.

Results

As noted, the overall rate of adequate prep was 89.3%, with rates of 94.7% and 86.7% for the split and same-day doses, respectively.

A breakdown of cleansing by bowel segment showed that, for each segment, the split-dose regimen was numerically superior to the same-day regimen, with rates of 95.6% versus 89.5% for the right colon, 97.1% versus 91.9% for the left colon, and 97.8% versus 93.1% for the transverse colon, respectively.

Mean BBPS scores were significantly better with split dosing, at 8.02 versus 6.96. Higher scores were seen with split-dosing for each colon segment.

The incidence of adverse events was low, at 2.3% overall, 1.4% for same-day dosing, and 3.9% for split dosing, with nausea the most common.

Tolerability is key

Renee L. Williams, MD, MHPE, FACG, from New York University, who moderated the session but was not involved in the study, commented that the more convenient 1L PEG+ASC regimen may be helpful with improving compliance with bowel prep in underserved populations.

“My population of patients is very different from the one in this study,” she said in an interview. “Normally, if you’re looking at people who are not prepped, at least in the United States, people who have a lot of comorbidities, who are underserved, or have insurance uncertainty tend to have a lower level of bowel prep. So I’d be curious to see whether this would work in that population.”

Dr. Williams noted that she prefers split dosing for bowel prep because it offers better tolerability for patients, adding that when her center introduced split-dose prep, the percentage of adequate prep rose from around 60% to more than 90%.

Comoderator John R. Saltzman, MD, FACG, from Harvard Medical School and Brigham & Women’s Hospital, both in Boston, said that while he’s not familiar with this specific bowel prep formulation, “I’m looking for whatever is most palatable to patients and most effective in practice. Still, most of our patients tolerate these 2-liter overnight preps very well.”

The 1L-PEG+ASC regimen may be a suitable option for patients whose colonoscopies are scheduled for later in the day, Dr. Saltzman added.

The study was supported by Norgine and Xolomon Tree. Dr. Arieira, Dr. Williams, and Dr. Saltzman reported no relevant conflicts of interest.

There’s some good overall news in a large analysis that looked at whether a mother’s COVID-19 infection or birth during the pandemic could affect a baby’s brain development.

Researchers studied 21,419 infants who had neurodevelopmental screening during the pandemic (from January 2020 to January 2021) and compared them with babies born before the pandemic (2015-2019).

They found in an analysis of eight studies that, generally, brain development in infants ages 6-12 months old was not changed by COVID-19.
 

Communication skill scores lower than prepandemic

However, one area did see a significant difference when they looked at answers to the Ages and Stages Questionnaire, 3rd edition (ASQ-3): Scores were lower in communication skills.

Compared with the prepandemic babies, the pandemic group of babies was more likely to have communication impairment (odds were 1.7 times higher).

Additionally, mothers’ SARS-CoV-2 infection was not associated with significant differences in any neurodevelopment sector in offspring, with one exception: Odds were 3.5 times higher for fine motor impairment in the pandemic baby group.

The babies in this study were either exposed in the womb to the SARS-CoV-2 infection or screened during the pandemic regardless of whether they were exposed to the virus.

The study, led by Kamran Hessami, MD, with the Maternal Fetal Care Center at Boston Children’s Hospital and Harvard Medical School in Boston, was published in JAMA Network Open.
 

Potential reasons for lower communication skills

The study points to some factors of the pandemic that may be tied to impaired communication skills.

“Higher levels of COVID-19–related stress were reported for both mothers and fathers of infants aged 0-6 months and were associated with insensitive parenting practices, including decreased emotional responsiveness in only mothers, which could lessen the reciprocal exchanges that support language development in early childhood,” they write. “Additionally, opportunities to promote language and social development through new experiences outside the home, including visits with extended family and friends or attendance at a child care center, were lessened for many during the pandemic.”

Viviana M. Fajardo Martinez, MD, with neonatal/perinatal medicine at University of California, Los Angeles, Health, told this publication her team is also studying child development before and after the pandemic over a 3-year period, and delayed communication skills is something she is seeing in clinic there.

She says some parents have been concerned, saying their babies aren’t talking enough or are behind in vocabulary.
 

Babies can catch up after 12 months

One thing she tells parents is that babies who are a bit delayed at 12 months can catch up.

Up to 18 months, they can catch up, she said, adding that they can be reevaluated then for improvement. If, at that point, the baby is not catching up, “that’s when we refer for early intervention,” she said.

Dr. Martinez also tells parents concerned about their infant’s communication skills that it’s important to talk, read, and sing to their child. She said amid pandemic stress, corners may have been cut in asking children to use language skills.

For instance, if a child points to an apple, a stressed parent may just give the child the apple instead of asking the child to request it by name and repeat the word several times.

She also said a limitation of this study is the use of the ASQ-3 questionnaire, which is filled out by parents. Answers are subjective, she notes, and sometimes differ between one child’s two parents. The questionnaire was commonly used during the pandemic because a more objective, professional evaluation has been more difficult.

However, a measure like the Bayley Scales of Infant and Toddler Development Screening Test adds objectivity and will likely give a better picture as research progresses, Dr. Martinez said. 
 

Some information missing

Andréane Lavallée, PhD, and Dani Dumitriu, MD, PhD, both with the department of pediatrics at Columbia University, New York, write in an invited commentary that the overall positive message of the study “should not make researchers complacent” and results should be viewed with caution.

They point out that the precise effects of this novel virus are still unclear and the age group and variables studied may not tell the whole story.

“It should be noted that this systematic review did not consider timing of exposure during pregnancy, maternal infection severity, or exposure to various SARS-CoV-2 variants – all factors that could eventually be proven to contribute to subtle adverse neurodevelopmental outcomes,” they write.

Additionally, past pandemics “such as the 1918 Spanish flu, 1964 rubella, and 2009 H1N1” have taught researchers to watch for increases in diagnoses such as autism spectrum disorder (ASD) and schizophrenia in subsequent years.

“ASD is generally diagnosed at age 3-5 years (and often not until early teens), while schizophrenia is generally diagnosed in mid-to-late 20s,” the editorialists point out. The authors agree and emphasize the need for long-term studies.

Authors report no relevant financial relationships. Editorialist Dr. Dumitriu reports grants from National Institute of Mental Health, the U.S. Centers for Disease Control and Prevention, and the W. K. Kellogg Foundation; and has received gift funds from Einhorn Collaborative during the conduct of the study to the Nurture Science Program, for which Dr Dumitriu serves as director. Dr. Dumitriu received personal fees from Medela outside the submitted work; and is the corresponding author for one of the studies (Shuffrey et al., 2022) included in the systematic review conducted by Dr. Hessami et al. Dr. Lavallée reports grants from the Canadian Institutes of Health Research. Dr. Martinez reports no relevant financial relationships.
 

There’s some good overall news in a large analysis that looked at whether a mother’s COVID-19 infection or birth during the pandemic could affect a baby’s brain development.

Researchers studied 21,419 infants who had neurodevelopmental screening during the pandemic (from January 2020 to January 2021) and compared them with babies born before the pandemic (2015-2019).

They found in an analysis of eight studies that, generally, brain development in infants ages 6-12 months old was not changed by COVID-19.
 

Communication skill scores lower than prepandemic

However, one area did see a significant difference when they looked at answers to the Ages and Stages Questionnaire, 3rd edition (ASQ-3): Scores were lower in communication skills.

Compared with the prepandemic babies, the pandemic group of babies was more likely to have communication impairment (odds were 1.7 times higher).

Additionally, mothers’ SARS-CoV-2 infection was not associated with significant differences in any neurodevelopment sector in offspring, with one exception: Odds were 3.5 times higher for fine motor impairment in the pandemic baby group.

The babies in this study were either exposed in the womb to the SARS-CoV-2 infection or screened during the pandemic regardless of whether they were exposed to the virus.

The study, led by Kamran Hessami, MD, with the Maternal Fetal Care Center at Boston Children’s Hospital and Harvard Medical School in Boston, was published in JAMA Network Open.
 

Potential reasons for lower communication skills

The study points to some factors of the pandemic that may be tied to impaired communication skills.

“Higher levels of COVID-19–related stress were reported for both mothers and fathers of infants aged 0-6 months and were associated with insensitive parenting practices, including decreased emotional responsiveness in only mothers, which could lessen the reciprocal exchanges that support language development in early childhood,” they write. “Additionally, opportunities to promote language and social development through new experiences outside the home, including visits with extended family and friends or attendance at a child care center, were lessened for many during the pandemic.”

Viviana M. Fajardo Martinez, MD, with neonatal/perinatal medicine at University of California, Los Angeles, Health, told this publication her team is also studying child development before and after the pandemic over a 3-year period, and delayed communication skills is something she is seeing in clinic there.

She says some parents have been concerned, saying their babies aren’t talking enough or are behind in vocabulary.
 

Babies can catch up after 12 months

One thing she tells parents is that babies who are a bit delayed at 12 months can catch up.

Up to 18 months, they can catch up, she said, adding that they can be reevaluated then for improvement. If, at that point, the baby is not catching up, “that’s when we refer for early intervention,” she said.

Dr. Martinez also tells parents concerned about their infant’s communication skills that it’s important to talk, read, and sing to their child. She said amid pandemic stress, corners may have been cut in asking children to use language skills.

For instance, if a child points to an apple, a stressed parent may just give the child the apple instead of asking the child to request it by name and repeat the word several times.

She also said a limitation of this study is the use of the ASQ-3 questionnaire, which is filled out by parents. Answers are subjective, she notes, and sometimes differ between one child’s two parents. The questionnaire was commonly used during the pandemic because a more objective, professional evaluation has been more difficult.

However, a measure like the Bayley Scales of Infant and Toddler Development Screening Test adds objectivity and will likely give a better picture as research progresses, Dr. Martinez said. 
 

Some information missing

Andréane Lavallée, PhD, and Dani Dumitriu, MD, PhD, both with the department of pediatrics at Columbia University, New York, write in an invited commentary that the overall positive message of the study “should not make researchers complacent” and results should be viewed with caution.

They point out that the precise effects of this novel virus are still unclear and the age group and variables studied may not tell the whole story.

“It should be noted that this systematic review did not consider timing of exposure during pregnancy, maternal infection severity, or exposure to various SARS-CoV-2 variants – all factors that could eventually be proven to contribute to subtle adverse neurodevelopmental outcomes,” they write.

Additionally, past pandemics “such as the 1918 Spanish flu, 1964 rubella, and 2009 H1N1” have taught researchers to watch for increases in diagnoses such as autism spectrum disorder (ASD) and schizophrenia in subsequent years.

“ASD is generally diagnosed at age 3-5 years (and often not until early teens), while schizophrenia is generally diagnosed in mid-to-late 20s,” the editorialists point out. The authors agree and emphasize the need for long-term studies.

Authors report no relevant financial relationships. Editorialist Dr. Dumitriu reports grants from National Institute of Mental Health, the U.S. Centers for Disease Control and Prevention, and the W. K. Kellogg Foundation; and has received gift funds from Einhorn Collaborative during the conduct of the study to the Nurture Science Program, for which Dr Dumitriu serves as director. Dr. Dumitriu received personal fees from Medela outside the submitted work; and is the corresponding author for one of the studies (Shuffrey et al., 2022) included in the systematic review conducted by Dr. Hessami et al. Dr. Lavallée reports grants from the Canadian Institutes of Health Research. Dr. Martinez reports no relevant financial relationships.
 

There’s some good overall news in a large analysis that looked at whether a mother’s COVID-19 infection or birth during the pandemic could affect a baby’s brain development.

Researchers studied 21,419 infants who had neurodevelopmental screening during the pandemic (from January 2020 to January 2021) and compared them with babies born before the pandemic (2015-2019).

They found in an analysis of eight studies that, generally, brain development in infants ages 6-12 months old was not changed by COVID-19.
 

Communication skill scores lower than prepandemic

However, one area did see a significant difference when they looked at answers to the Ages and Stages Questionnaire, 3rd edition (ASQ-3): Scores were lower in communication skills.

Compared with the prepandemic babies, the pandemic group of babies was more likely to have communication impairment (odds were 1.7 times higher).

Additionally, mothers’ SARS-CoV-2 infection was not associated with significant differences in any neurodevelopment sector in offspring, with one exception: Odds were 3.5 times higher for fine motor impairment in the pandemic baby group.

The babies in this study were either exposed in the womb to the SARS-CoV-2 infection or screened during the pandemic regardless of whether they were exposed to the virus.

The study, led by Kamran Hessami, MD, with the Maternal Fetal Care Center at Boston Children’s Hospital and Harvard Medical School in Boston, was published in JAMA Network Open.
 

Potential reasons for lower communication skills

The study points to some factors of the pandemic that may be tied to impaired communication skills.

“Higher levels of COVID-19–related stress were reported for both mothers and fathers of infants aged 0-6 months and were associated with insensitive parenting practices, including decreased emotional responsiveness in only mothers, which could lessen the reciprocal exchanges that support language development in early childhood,” they write. “Additionally, opportunities to promote language and social development through new experiences outside the home, including visits with extended family and friends or attendance at a child care center, were lessened for many during the pandemic.”

Viviana M. Fajardo Martinez, MD, with neonatal/perinatal medicine at University of California, Los Angeles, Health, told this publication her team is also studying child development before and after the pandemic over a 3-year period, and delayed communication skills is something she is seeing in clinic there.

She says some parents have been concerned, saying their babies aren’t talking enough or are behind in vocabulary.
 

Babies can catch up after 12 months

One thing she tells parents is that babies who are a bit delayed at 12 months can catch up.

Up to 18 months, they can catch up, she said, adding that they can be reevaluated then for improvement. If, at that point, the baby is not catching up, “that’s when we refer for early intervention,” she said.

Dr. Martinez also tells parents concerned about their infant’s communication skills that it’s important to talk, read, and sing to their child. She said amid pandemic stress, corners may have been cut in asking children to use language skills.

For instance, if a child points to an apple, a stressed parent may just give the child the apple instead of asking the child to request it by name and repeat the word several times.

She also said a limitation of this study is the use of the ASQ-3 questionnaire, which is filled out by parents. Answers are subjective, she notes, and sometimes differ between one child’s two parents. The questionnaire was commonly used during the pandemic because a more objective, professional evaluation has been more difficult.

However, a measure like the Bayley Scales of Infant and Toddler Development Screening Test adds objectivity and will likely give a better picture as research progresses, Dr. Martinez said. 
 

Some information missing

Andréane Lavallée, PhD, and Dani Dumitriu, MD, PhD, both with the department of pediatrics at Columbia University, New York, write in an invited commentary that the overall positive message of the study “should not make researchers complacent” and results should be viewed with caution.

They point out that the precise effects of this novel virus are still unclear and the age group and variables studied may not tell the whole story.

“It should be noted that this systematic review did not consider timing of exposure during pregnancy, maternal infection severity, or exposure to various SARS-CoV-2 variants – all factors that could eventually be proven to contribute to subtle adverse neurodevelopmental outcomes,” they write.

Additionally, past pandemics “such as the 1918 Spanish flu, 1964 rubella, and 2009 H1N1” have taught researchers to watch for increases in diagnoses such as autism spectrum disorder (ASD) and schizophrenia in subsequent years.

“ASD is generally diagnosed at age 3-5 years (and often not until early teens), while schizophrenia is generally diagnosed in mid-to-late 20s,” the editorialists point out. The authors agree and emphasize the need for long-term studies.

Authors report no relevant financial relationships. Editorialist Dr. Dumitriu reports grants from National Institute of Mental Health, the U.S. Centers for Disease Control and Prevention, and the W. K. Kellogg Foundation; and has received gift funds from Einhorn Collaborative during the conduct of the study to the Nurture Science Program, for which Dr Dumitriu serves as director. Dr. Dumitriu received personal fees from Medela outside the submitted work; and is the corresponding author for one of the studies (Shuffrey et al., 2022) included in the systematic review conducted by Dr. Hessami et al. Dr. Lavallée reports grants from the Canadian Institutes of Health Research. Dr. Martinez reports no relevant financial relationships.
 

Cardiorespiratory fitness protects against declines in gait quality in patients with multiple sclerosis (MS), new research shows. Investigators found that over time, lower cardiorespiratory fitness predicts increased variability in stride time and could represent a biomarker for subtle neuromuscular decline in patients with MS.

Cardiorespiratory fitness “may exert neuroprotective effects on the central nervous system,” study investigator Syamala Buragadda, neurophysical therapist and PhD candidate, Memorial University, St. John’s, Nfld..

She reported her research at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Gait changes

Gait is a complicated process involving coordination of multiple systems, but steps are almost always consistent and symmetric, said Ms. Buragadda. Patients with MS can experience subtle declines in gait quality even without relapses. Considering the neuroprotective properties of exercise, having higher fitness levels could prevent brain atrophy and protect against subtle gait changes.

Calculating stride time variability is a sensitive method to map changes in gait quality.

Ms. Buragadda, with co-investigator Michelle Ploughman, PhD, also with Memorial University, evaluated stride time variability over time in people with MS and explored whether cardiorespiratory fitness predicts stride time variability.

They recruited 49 adults with relapsing-remitting MS (63% women) and mild disability (Expanded Disability Status Scale [EDSS] score < 4; median, 2.0) from MS clinics in Canada. None required walking aids, and none had experienced relapses in the prior 3 months.

Gait quality was assessed on an instrumented walkway, and variability was measured as the coefficient of variation of stride time. Cardiorespiratory fitness was measured as maximal oxygen uptake (VO₂max) during a graded exercise test using recumbent stepper. Tests were conducted 2 years apart.

There were no significant changes in EDSS scores over the study period. However, stride time variability increased from 7.3% at baseline to 8.3% at 2 years.

Cardiorespiratory fitness at baseline significantly correlated with stride time variability 2 years later (P = .016) and was a significant predictor of stride time variability at 2 years, accounting for 10% of its variance, Ms. Buragadda reported.

Stride time variability, measured on an instrumented walkway, could be a biomarker for subtle changes to walking and balance, she said.

Limitations of the study include a convenience sample that may not represent the diversity of MS. Also, assessments were made at only two time points, and more time points would likely yield better predictive power. In addition, the lack of MRI images limits correlating structural changes with clinical observations of gait changes.
 

A buffer against disability?

In a comment, Valerie Block, physical therapist and adjunct instructor, department of physical therapy and rehabilitation science, University of California, San Francisco, and UCSF Weill Institute for Neuroscience, said the findings in this study are not surprising and align with what she has observed, subjectively, in her work.

“In the general population, cardiovascular fitness has a wide array of benefits. Depending on what means the person uses to maintain or improve cardiovascular fitness (that is, running, walking, swimming, etc.), this would have the potential for neuroplastic effects on gait – even in MS and other neurological disorders,” Ms. Block said.

Also offering perspective, Brain Sandroff, PhD, senior research scientist, Kessler Foundation, West Orange, N.J., said the study provides “more evidence on the multisystemic benefits of exercise training and having better physical fitness in persons with MS. The evidence seems to be converging more and more on this, as research groups across countries and continents are reporting on similar themes,” said Dr. Sandroff.

He noted that the findings from this study coincide with some other data that showed that premorbid physical activity is associated with reduced mobility decline over time in persons with MS.

“Collectively, the data suggest that perhaps engaging in exercise training early in the disease (or having better cardiorespiratory fitness at diagnosis) provides a buffer against disability progression over time,” Dr. Sandroff said.

He said it would be interesting to see whether “physical fitness/premorbid physical activity provides such a buffer in those who already demonstrate mobility problems.”

The study had no specific funding. Ms. Buragadda, Dr. Ploughman, Ms. Block, and Dr. Sandroff have disclosed no relevant financial relationships.

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

Cardiorespiratory fitness protects against declines in gait quality in patients with multiple sclerosis (MS), new research shows. Investigators found that over time, lower cardiorespiratory fitness predicts increased variability in stride time and could represent a biomarker for subtle neuromuscular decline in patients with MS.

Cardiorespiratory fitness “may exert neuroprotective effects on the central nervous system,” study investigator Syamala Buragadda, neurophysical therapist and PhD candidate, Memorial University, St. John’s, Nfld..

She reported her research at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Gait changes

Gait is a complicated process involving coordination of multiple systems, but steps are almost always consistent and symmetric, said Ms. Buragadda. Patients with MS can experience subtle declines in gait quality even without relapses. Considering the neuroprotective properties of exercise, having higher fitness levels could prevent brain atrophy and protect against subtle gait changes.

Calculating stride time variability is a sensitive method to map changes in gait quality.

Ms. Buragadda, with co-investigator Michelle Ploughman, PhD, also with Memorial University, evaluated stride time variability over time in people with MS and explored whether cardiorespiratory fitness predicts stride time variability.

They recruited 49 adults with relapsing-remitting MS (63% women) and mild disability (Expanded Disability Status Scale [EDSS] score < 4; median, 2.0) from MS clinics in Canada. None required walking aids, and none had experienced relapses in the prior 3 months.

Gait quality was assessed on an instrumented walkway, and variability was measured as the coefficient of variation of stride time. Cardiorespiratory fitness was measured as maximal oxygen uptake (VO₂max) during a graded exercise test using recumbent stepper. Tests were conducted 2 years apart.

There were no significant changes in EDSS scores over the study period. However, stride time variability increased from 7.3% at baseline to 8.3% at 2 years.

Cardiorespiratory fitness at baseline significantly correlated with stride time variability 2 years later (P = .016) and was a significant predictor of stride time variability at 2 years, accounting for 10% of its variance, Ms. Buragadda reported.

Stride time variability, measured on an instrumented walkway, could be a biomarker for subtle changes to walking and balance, she said.

Limitations of the study include a convenience sample that may not represent the diversity of MS. Also, assessments were made at only two time points, and more time points would likely yield better predictive power. In addition, the lack of MRI images limits correlating structural changes with clinical observations of gait changes.
 

A buffer against disability?

In a comment, Valerie Block, physical therapist and adjunct instructor, department of physical therapy and rehabilitation science, University of California, San Francisco, and UCSF Weill Institute for Neuroscience, said the findings in this study are not surprising and align with what she has observed, subjectively, in her work.

“In the general population, cardiovascular fitness has a wide array of benefits. Depending on what means the person uses to maintain or improve cardiovascular fitness (that is, running, walking, swimming, etc.), this would have the potential for neuroplastic effects on gait – even in MS and other neurological disorders,” Ms. Block said.

Also offering perspective, Brain Sandroff, PhD, senior research scientist, Kessler Foundation, West Orange, N.J., said the study provides “more evidence on the multisystemic benefits of exercise training and having better physical fitness in persons with MS. The evidence seems to be converging more and more on this, as research groups across countries and continents are reporting on similar themes,” said Dr. Sandroff.

He noted that the findings from this study coincide with some other data that showed that premorbid physical activity is associated with reduced mobility decline over time in persons with MS.

“Collectively, the data suggest that perhaps engaging in exercise training early in the disease (or having better cardiorespiratory fitness at diagnosis) provides a buffer against disability progression over time,” Dr. Sandroff said.

He said it would be interesting to see whether “physical fitness/premorbid physical activity provides such a buffer in those who already demonstrate mobility problems.”

The study had no specific funding. Ms. Buragadda, Dr. Ploughman, Ms. Block, and Dr. Sandroff have disclosed no relevant financial relationships.

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

Cardiorespiratory fitness protects against declines in gait quality in patients with multiple sclerosis (MS), new research shows. Investigators found that over time, lower cardiorespiratory fitness predicts increased variability in stride time and could represent a biomarker for subtle neuromuscular decline in patients with MS.

Cardiorespiratory fitness “may exert neuroprotective effects on the central nervous system,” study investigator Syamala Buragadda, neurophysical therapist and PhD candidate, Memorial University, St. John’s, Nfld..

She reported her research at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Gait changes

Gait is a complicated process involving coordination of multiple systems, but steps are almost always consistent and symmetric, said Ms. Buragadda. Patients with MS can experience subtle declines in gait quality even without relapses. Considering the neuroprotective properties of exercise, having higher fitness levels could prevent brain atrophy and protect against subtle gait changes.

Calculating stride time variability is a sensitive method to map changes in gait quality.

Ms. Buragadda, with co-investigator Michelle Ploughman, PhD, also with Memorial University, evaluated stride time variability over time in people with MS and explored whether cardiorespiratory fitness predicts stride time variability.

They recruited 49 adults with relapsing-remitting MS (63% women) and mild disability (Expanded Disability Status Scale [EDSS] score < 4; median, 2.0) from MS clinics in Canada. None required walking aids, and none had experienced relapses in the prior 3 months.

Gait quality was assessed on an instrumented walkway, and variability was measured as the coefficient of variation of stride time. Cardiorespiratory fitness was measured as maximal oxygen uptake (VO₂max) during a graded exercise test using recumbent stepper. Tests were conducted 2 years apart.

There were no significant changes in EDSS scores over the study period. However, stride time variability increased from 7.3% at baseline to 8.3% at 2 years.

Cardiorespiratory fitness at baseline significantly correlated with stride time variability 2 years later (P = .016) and was a significant predictor of stride time variability at 2 years, accounting for 10% of its variance, Ms. Buragadda reported.

Stride time variability, measured on an instrumented walkway, could be a biomarker for subtle changes to walking and balance, she said.

Limitations of the study include a convenience sample that may not represent the diversity of MS. Also, assessments were made at only two time points, and more time points would likely yield better predictive power. In addition, the lack of MRI images limits correlating structural changes with clinical observations of gait changes.
 

A buffer against disability?

In a comment, Valerie Block, physical therapist and adjunct instructor, department of physical therapy and rehabilitation science, University of California, San Francisco, and UCSF Weill Institute for Neuroscience, said the findings in this study are not surprising and align with what she has observed, subjectively, in her work.

“In the general population, cardiovascular fitness has a wide array of benefits. Depending on what means the person uses to maintain or improve cardiovascular fitness (that is, running, walking, swimming, etc.), this would have the potential for neuroplastic effects on gait – even in MS and other neurological disorders,” Ms. Block said.

Also offering perspective, Brain Sandroff, PhD, senior research scientist, Kessler Foundation, West Orange, N.J., said the study provides “more evidence on the multisystemic benefits of exercise training and having better physical fitness in persons with MS. The evidence seems to be converging more and more on this, as research groups across countries and continents are reporting on similar themes,” said Dr. Sandroff.

He noted that the findings from this study coincide with some other data that showed that premorbid physical activity is associated with reduced mobility decline over time in persons with MS.

“Collectively, the data suggest that perhaps engaging in exercise training early in the disease (or having better cardiorespiratory fitness at diagnosis) provides a buffer against disability progression over time,” Dr. Sandroff said.

He said it would be interesting to see whether “physical fitness/premorbid physical activity provides such a buffer in those who already demonstrate mobility problems.”

The study had no specific funding. Ms. Buragadda, Dr. Ploughman, Ms. Block, and Dr. Sandroff have disclosed no relevant financial relationships.

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

Arguably, no topic during an infertility consultation generates more of an emotional reaction than discussing body mass index (BMI), particularly when it is high. Patients have become increasingly sensitive to weight discussions with their physicians because of concerns about body shaming. Among patients with an elevated BMI, criticism on social media of health care professionals’ counseling and a preemptive presentation of “Don’t Weigh Me” cards have become popular responses. Despite the medical evidence on impaired reproduction with an abnormal BMI, patients are choosing to forgo the topic. Research has demonstrated “extensive evidence [of] strong weight bias” in a wide range of health staff.¹ A “viral” TikTok study revealed that medical “gaslighting” founded in weight stigma and bias is harmful, as reported on KevinMD.com.² This month, we review the effect of abnormal BMI, both high and low, on reproduction and pregnancy.

A method to assess relative weight was first described in 1832 as its ratio in kilograms divided by the square of the height in meters, or the Quetelet Index. The search for a functional assessment of relative body weight began after World War II when reports by actuaries noted the increased mortality of overweight policyholders. The relationship between weight and cardiovascular disease was further revealed in epidemiologic studies. The Quetelet Index became the BMI in 1972.³

Weight measurement is a mainstay in the assessment of a patient’s vital signs along with blood pressure, pulse rate, respiration rate, and temperature. Weight is vital to the calculation of medication dosage – for instance, administration of conscious sedative drugs, methotrexate, and gonadotropins. Some state boards of medicine, such as Florida, have a limitation on patient BMI at office-based surgery centers (40 kg/m²).
 

Obesity is a disease

As reported by the World Health Organization in 2022, the disease of obesity is an epidemic afflicting more than 1 billion people worldwide, or 1 in 8 individuals globally.⁴ The health implications of an elevated BMI include increased mortality, diabetes, heart disease, and stroke, physical limitations to activities of daily living, and complications affecting reproduction.

Female obesity is related to poorer outcomes in natural and assisted conception, including an increased risk of miscarriage. Compared with normal-weight women, those with obesity are three times more likely to have ovulatory dysfunction,⁵ infertility,⁶ a lower chance for conception,⁷ higher rate of miscarriage, and low birth weight.^8,9During pregnancy, women with obesity have three to four times higher rates of gestational diabetes and preeclampsia,¹⁰ as well as likelihood of delivering preterm,¹¹ having a fetus with macrosomia and birth defects, and a 1.3- to 2.1-times higher risk of stillbirth.¹²

Obesity is present in 40%-80% of women with polycystic ovary syndrome,¹³ the most common cause of ovulatory dysfunction from dysregulation of the hypothalamic-pituitary-ovarian axis. While PCOS is associated with reproductive and metabolic consequences, even in regularly ovulating women, increasing obesity appears to be associated with decreasing spontaneous pregnancy rates and increased time to pregnancy.¹⁴

Obesity and IVF

Women with obesity have reduced success with assisted reproductive technology, an increased number of canceled cycles, and poorer quality oocytes retrieved. A prospective cohort study of nearly 2,000 women reported that every 5 kg of body weight increase (from the patient’s baseline weight at age 18) was associated with a 5% increase in the mean duration of time required for conception (95% confidence interval, 3%-7%).¹⁵ Given that approximately 90% of these women had regular menstrual cycles, ovulatory dysfunction was not the suspected pathophysiology.

A meta-analysis of 21 cohort studies reported a lower likelihood of live birth following in vitro fertilization for women with obesity, compared with normal-weight women (risk ratio, 0.85; 95% CI, 0.82-0.87).¹⁶ A further subgroup analysis that evaluated only women with PCOS showed a reduction in the live birth rate following IVF for individuals with obesity, compared with normal-weight individuals (RR, 0.78; 95% CI, 0.74-0.82).

In a retrospective study of almost 500,000 fresh autologous IVF cycles, women with obesity had a 6% reduction in pregnancy rates and a 13% reduction in live birth rates, compared with normal-weight women. Both high and low BMI were associated with an increased risk of low birth weight and preterm delivery.¹⁷ The live birth rates per transfer for normal-weight and higher-weight women were 38% and 33%, respectively.

Contrarily, a randomized controlled trial showed that an intensive weight-reduction program resulted in a large weight loss but did not substantially affect live birth rates in women with obesity scheduled for IVF.¹⁸

Low BMI

A noteworthy cause of low BMI is functional hypothalamic amenorrhea (FHA), a disorder with low energy availability either from decreased caloric intake and/or excessive energy expenditure associated with eating disorders, excessive exercise, and stress. Consequently, a reduced GnRH drive results in a decreased pulse frequency and amplitude leading to low levels of follicle-stimulating hormone and luteinizing hormone, resulting in anovulation. Correction of lifestyle behaviors related to FHA can restore menstrual cycles. After normal weight is achieved, it appears unlikely that fertility is affected.¹⁹ In 47% of adolescent patients with anorexia, menses spontaneously returned within the first 12 months after admission, with an improved prognosis in secondary over primary amenorrhea.^20,21 Interestingly, mildly and significantly underweight infertile women have pregnancy and live birth rates similar to normal-weight patients after IVF treatment.²²

Pregnancy is complicated in underweight women, resulting in an increased risk of anemia, fetal growth retardation, and low birth weight, as well as preterm birth.²¹

Take-home message

The extremes of BMI both impair natural reproduction. Elevated BMI reduces success with IVF but rapid weight loss prior to IVF does not improve outcomes. A normal BMI is the goal for optimal reproductive and pregnancy health.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
 

References

1. Talumaa B et al. Obesity Rev. 2022;23:e13494.

2. https://bit.ly/3rHCivE.

3. Eknoyan G. Nephrol Dial Transplant. 2008;23:47-51.

4. Wells JCK. Dis Models Mech. 2012;5:595-607.

5. Brewer CJ and Balen AH. Reproduction. 2010;140:347-64.

6. Silvestris E et al. Reprod Biol Endocrinol. 2018;16:22.

7. Wise LA et al. Hum Reprod. 2010;25:253-64.

8. Bellver J. Curr Opin Obstet Gynecol. 2022;34:114-21.

9. Dickey RP et al. Am J Obstet Gynecol. 2013;209:349.e1.

10. Alwash SM et al. Obes Res Clin Pract. 2021;15:425-30.

11. Cnattingius S et al. JAMA. 2013;309:2362-70.

12. Aune D et al. JAMA. 2014;311:1536-46.

13. Sam S. Obes Manag. 2007;3:69-73.

14. van der Steeg JW et al. Hum Reprod. 2008;23:324-8.

15. Gaskins AJ et al. Obstet Gynecol. 2015;126:850-8.

16. Sermondade N et al. Hum Reprod Update. 2019;25:439-519.

17. Kawwass JF et al. Fertil Steril. 2016;106[7]:1742-50.

18. Einarsson S et al. Hum Reprod. 2017;32:1621-30.

19. Chaer R et al. Diseases. 2020;8:46.

20. Dempfle A et al. Psychiatry. 2013;13:308.

21. Verma A and Shrimali L. J Clin Diagn Res. 2012;6:1531-3.

22. Romanski PA et al. Reprod Biomed Online. 2020;42:366-74.

Arguably, no topic during an infertility consultation generates more of an emotional reaction than discussing body mass index (BMI), particularly when it is high. Patients have become increasingly sensitive to weight discussions with their physicians because of concerns about body shaming. Among patients with an elevated BMI, criticism on social media of health care professionals’ counseling and a preemptive presentation of “Don’t Weigh Me” cards have become popular responses. Despite the medical evidence on impaired reproduction with an abnormal BMI, patients are choosing to forgo the topic. Research has demonstrated “extensive evidence [of] strong weight bias” in a wide range of health staff.¹ A “viral” TikTok study revealed that medical “gaslighting” founded in weight stigma and bias is harmful, as reported on KevinMD.com.² This month, we review the effect of abnormal BMI, both high and low, on reproduction and pregnancy.

A method to assess relative weight was first described in 1832 as its ratio in kilograms divided by the square of the height in meters, or the Quetelet Index. The search for a functional assessment of relative body weight began after World War II when reports by actuaries noted the increased mortality of overweight policyholders. The relationship between weight and cardiovascular disease was further revealed in epidemiologic studies. The Quetelet Index became the BMI in 1972.³

Weight measurement is a mainstay in the assessment of a patient’s vital signs along with blood pressure, pulse rate, respiration rate, and temperature. Weight is vital to the calculation of medication dosage – for instance, administration of conscious sedative drugs, methotrexate, and gonadotropins. Some state boards of medicine, such as Florida, have a limitation on patient BMI at office-based surgery centers (40 kg/m²).
 

Obesity is a disease

As reported by the World Health Organization in 2022, the disease of obesity is an epidemic afflicting more than 1 billion people worldwide, or 1 in 8 individuals globally.⁴ The health implications of an elevated BMI include increased mortality, diabetes, heart disease, and stroke, physical limitations to activities of daily living, and complications affecting reproduction.

Female obesity is related to poorer outcomes in natural and assisted conception, including an increased risk of miscarriage. Compared with normal-weight women, those with obesity are three times more likely to have ovulatory dysfunction,⁵ infertility,⁶ a lower chance for conception,⁷ higher rate of miscarriage, and low birth weight.^8,9During pregnancy, women with obesity have three to four times higher rates of gestational diabetes and preeclampsia,¹⁰ as well as likelihood of delivering preterm,¹¹ having a fetus with macrosomia and birth defects, and a 1.3- to 2.1-times higher risk of stillbirth.¹²

Obesity is present in 40%-80% of women with polycystic ovary syndrome,¹³ the most common cause of ovulatory dysfunction from dysregulation of the hypothalamic-pituitary-ovarian axis. While PCOS is associated with reproductive and metabolic consequences, even in regularly ovulating women, increasing obesity appears to be associated with decreasing spontaneous pregnancy rates and increased time to pregnancy.¹⁴

Obesity and IVF

Women with obesity have reduced success with assisted reproductive technology, an increased number of canceled cycles, and poorer quality oocytes retrieved. A prospective cohort study of nearly 2,000 women reported that every 5 kg of body weight increase (from the patient’s baseline weight at age 18) was associated with a 5% increase in the mean duration of time required for conception (95% confidence interval, 3%-7%).¹⁵ Given that approximately 90% of these women had regular menstrual cycles, ovulatory dysfunction was not the suspected pathophysiology.

A meta-analysis of 21 cohort studies reported a lower likelihood of live birth following in vitro fertilization for women with obesity, compared with normal-weight women (risk ratio, 0.85; 95% CI, 0.82-0.87).¹⁶ A further subgroup analysis that evaluated only women with PCOS showed a reduction in the live birth rate following IVF for individuals with obesity, compared with normal-weight individuals (RR, 0.78; 95% CI, 0.74-0.82).

In a retrospective study of almost 500,000 fresh autologous IVF cycles, women with obesity had a 6% reduction in pregnancy rates and a 13% reduction in live birth rates, compared with normal-weight women. Both high and low BMI were associated with an increased risk of low birth weight and preterm delivery.¹⁷ The live birth rates per transfer for normal-weight and higher-weight women were 38% and 33%, respectively.

Contrarily, a randomized controlled trial showed that an intensive weight-reduction program resulted in a large weight loss but did not substantially affect live birth rates in women with obesity scheduled for IVF.¹⁸

Low BMI

A noteworthy cause of low BMI is functional hypothalamic amenorrhea (FHA), a disorder with low energy availability either from decreased caloric intake and/or excessive energy expenditure associated with eating disorders, excessive exercise, and stress. Consequently, a reduced GnRH drive results in a decreased pulse frequency and amplitude leading to low levels of follicle-stimulating hormone and luteinizing hormone, resulting in anovulation. Correction of lifestyle behaviors related to FHA can restore menstrual cycles. After normal weight is achieved, it appears unlikely that fertility is affected.¹⁹ In 47% of adolescent patients with anorexia, menses spontaneously returned within the first 12 months after admission, with an improved prognosis in secondary over primary amenorrhea.^20,21 Interestingly, mildly and significantly underweight infertile women have pregnancy and live birth rates similar to normal-weight patients after IVF treatment.²²

Pregnancy is complicated in underweight women, resulting in an increased risk of anemia, fetal growth retardation, and low birth weight, as well as preterm birth.²¹

Take-home message

The extremes of BMI both impair natural reproduction. Elevated BMI reduces success with IVF but rapid weight loss prior to IVF does not improve outcomes. A normal BMI is the goal for optimal reproductive and pregnancy health.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
 

References

1. Talumaa B et al. Obesity Rev. 2022;23:e13494.

2. https://bit.ly/3rHCivE.

3. Eknoyan G. Nephrol Dial Transplant. 2008;23:47-51.

4. Wells JCK. Dis Models Mech. 2012;5:595-607.

5. Brewer CJ and Balen AH. Reproduction. 2010;140:347-64.

6. Silvestris E et al. Reprod Biol Endocrinol. 2018;16:22.

7. Wise LA et al. Hum Reprod. 2010;25:253-64.

8. Bellver J. Curr Opin Obstet Gynecol. 2022;34:114-21.

9. Dickey RP et al. Am J Obstet Gynecol. 2013;209:349.e1.

10. Alwash SM et al. Obes Res Clin Pract. 2021;15:425-30.

11. Cnattingius S et al. JAMA. 2013;309:2362-70.

12. Aune D et al. JAMA. 2014;311:1536-46.

13. Sam S. Obes Manag. 2007;3:69-73.

14. van der Steeg JW et al. Hum Reprod. 2008;23:324-8.

15. Gaskins AJ et al. Obstet Gynecol. 2015;126:850-8.

16. Sermondade N et al. Hum Reprod Update. 2019;25:439-519.

17. Kawwass JF et al. Fertil Steril. 2016;106[7]:1742-50.

18. Einarsson S et al. Hum Reprod. 2017;32:1621-30.

19. Chaer R et al. Diseases. 2020;8:46.

20. Dempfle A et al. Psychiatry. 2013;13:308.

21. Verma A and Shrimali L. J Clin Diagn Res. 2012;6:1531-3.

22. Romanski PA et al. Reprod Biomed Online. 2020;42:366-74.

Arguably, no topic during an infertility consultation generates more of an emotional reaction than discussing body mass index (BMI), particularly when it is high. Patients have become increasingly sensitive to weight discussions with their physicians because of concerns about body shaming. Among patients with an elevated BMI, criticism on social media of health care professionals’ counseling and a preemptive presentation of “Don’t Weigh Me” cards have become popular responses. Despite the medical evidence on impaired reproduction with an abnormal BMI, patients are choosing to forgo the topic. Research has demonstrated “extensive evidence [of] strong weight bias” in a wide range of health staff.¹ A “viral” TikTok study revealed that medical “gaslighting” founded in weight stigma and bias is harmful, as reported on KevinMD.com.² This month, we review the effect of abnormal BMI, both high and low, on reproduction and pregnancy.

A method to assess relative weight was first described in 1832 as its ratio in kilograms divided by the square of the height in meters, or the Quetelet Index. The search for a functional assessment of relative body weight began after World War II when reports by actuaries noted the increased mortality of overweight policyholders. The relationship between weight and cardiovascular disease was further revealed in epidemiologic studies. The Quetelet Index became the BMI in 1972.³

Weight measurement is a mainstay in the assessment of a patient’s vital signs along with blood pressure, pulse rate, respiration rate, and temperature. Weight is vital to the calculation of medication dosage – for instance, administration of conscious sedative drugs, methotrexate, and gonadotropins. Some state boards of medicine, such as Florida, have a limitation on patient BMI at office-based surgery centers (40 kg/m²).
 

Obesity is a disease

As reported by the World Health Organization in 2022, the disease of obesity is an epidemic afflicting more than 1 billion people worldwide, or 1 in 8 individuals globally.⁴ The health implications of an elevated BMI include increased mortality, diabetes, heart disease, and stroke, physical limitations to activities of daily living, and complications affecting reproduction.

Female obesity is related to poorer outcomes in natural and assisted conception, including an increased risk of miscarriage. Compared with normal-weight women, those with obesity are three times more likely to have ovulatory dysfunction,⁵ infertility,⁶ a lower chance for conception,⁷ higher rate of miscarriage, and low birth weight.^8,9During pregnancy, women with obesity have three to four times higher rates of gestational diabetes and preeclampsia,¹⁰ as well as likelihood of delivering preterm,¹¹ having a fetus with macrosomia and birth defects, and a 1.3- to 2.1-times higher risk of stillbirth.¹²

Obesity is present in 40%-80% of women with polycystic ovary syndrome,¹³ the most common cause of ovulatory dysfunction from dysregulation of the hypothalamic-pituitary-ovarian axis. While PCOS is associated with reproductive and metabolic consequences, even in regularly ovulating women, increasing obesity appears to be associated with decreasing spontaneous pregnancy rates and increased time to pregnancy.¹⁴

Obesity and IVF

Women with obesity have reduced success with assisted reproductive technology, an increased number of canceled cycles, and poorer quality oocytes retrieved. A prospective cohort study of nearly 2,000 women reported that every 5 kg of body weight increase (from the patient’s baseline weight at age 18) was associated with a 5% increase in the mean duration of time required for conception (95% confidence interval, 3%-7%).¹⁵ Given that approximately 90% of these women had regular menstrual cycles, ovulatory dysfunction was not the suspected pathophysiology.

A meta-analysis of 21 cohort studies reported a lower likelihood of live birth following in vitro fertilization for women with obesity, compared with normal-weight women (risk ratio, 0.85; 95% CI, 0.82-0.87).¹⁶ A further subgroup analysis that evaluated only women with PCOS showed a reduction in the live birth rate following IVF for individuals with obesity, compared with normal-weight individuals (RR, 0.78; 95% CI, 0.74-0.82).

In a retrospective study of almost 500,000 fresh autologous IVF cycles, women with obesity had a 6% reduction in pregnancy rates and a 13% reduction in live birth rates, compared with normal-weight women. Both high and low BMI were associated with an increased risk of low birth weight and preterm delivery.¹⁷ The live birth rates per transfer for normal-weight and higher-weight women were 38% and 33%, respectively.

Contrarily, a randomized controlled trial showed that an intensive weight-reduction program resulted in a large weight loss but did not substantially affect live birth rates in women with obesity scheduled for IVF.¹⁸

Low BMI

A noteworthy cause of low BMI is functional hypothalamic amenorrhea (FHA), a disorder with low energy availability either from decreased caloric intake and/or excessive energy expenditure associated with eating disorders, excessive exercise, and stress. Consequently, a reduced GnRH drive results in a decreased pulse frequency and amplitude leading to low levels of follicle-stimulating hormone and luteinizing hormone, resulting in anovulation. Correction of lifestyle behaviors related to FHA can restore menstrual cycles. After normal weight is achieved, it appears unlikely that fertility is affected.¹⁹ In 47% of adolescent patients with anorexia, menses spontaneously returned within the first 12 months after admission, with an improved prognosis in secondary over primary amenorrhea.^20,21 Interestingly, mildly and significantly underweight infertile women have pregnancy and live birth rates similar to normal-weight patients after IVF treatment.²²

Pregnancy is complicated in underweight women, resulting in an increased risk of anemia, fetal growth retardation, and low birth weight, as well as preterm birth.²¹

Take-home message

The extremes of BMI both impair natural reproduction. Elevated BMI reduces success with IVF but rapid weight loss prior to IVF does not improve outcomes. A normal BMI is the goal for optimal reproductive and pregnancy health.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
 

References

1. Talumaa B et al. Obesity Rev. 2022;23:e13494.

2. https://bit.ly/3rHCivE.

3. Eknoyan G. Nephrol Dial Transplant. 2008;23:47-51.

4. Wells JCK. Dis Models Mech. 2012;5:595-607.

5. Brewer CJ and Balen AH. Reproduction. 2010;140:347-64.

6. Silvestris E et al. Reprod Biol Endocrinol. 2018;16:22.

7. Wise LA et al. Hum Reprod. 2010;25:253-64.

8. Bellver J. Curr Opin Obstet Gynecol. 2022;34:114-21.

9. Dickey RP et al. Am J Obstet Gynecol. 2013;209:349.e1.

10. Alwash SM et al. Obes Res Clin Pract. 2021;15:425-30.

11. Cnattingius S et al. JAMA. 2013;309:2362-70.

12. Aune D et al. JAMA. 2014;311:1536-46.

13. Sam S. Obes Manag. 2007;3:69-73.

14. van der Steeg JW et al. Hum Reprod. 2008;23:324-8.

15. Gaskins AJ et al. Obstet Gynecol. 2015;126:850-8.

16. Sermondade N et al. Hum Reprod Update. 2019;25:439-519.

17. Kawwass JF et al. Fertil Steril. 2016;106[7]:1742-50.

18. Einarsson S et al. Hum Reprod. 2017;32:1621-30.

19. Chaer R et al. Diseases. 2020;8:46.

20. Dempfle A et al. Psychiatry. 2013;13:308.

21. Verma A and Shrimali L. J Clin Diagn Res. 2012;6:1531-3.

22. Romanski PA et al. Reprod Biomed Online. 2020;42:366-74.

When a consumer uses a health plan provider directory to look up a physician, there’s a high probability that the entry for that doctor is incomplete or inaccurate. The Centers for Medicare & Medicaid Services would like to change that by creating a National Directory of Healthcare Providers and Services, which the agency believes would be more valuable to consumers.

In asking for public comments on whether and how it should establish the directory, CMS argues that this data repository would help patients locate physicians and could help with care coordination, health information exchange, and public health data reporting.

However, it’s not clear that such a directory would be any better than current insurance company listings or that people would use it. But a national directory could benefit physician practices by reducing their administrative work, according to observers.

In requesting public comment on the proposed national directory, CMS explains that provider organizations face “redundant and burdensome reporting requirements to multiple databases.” The directory could greatly reduce this challenge by requiring health care organizations to report provider information to a single database. Currently, physician practices have to submit these data to an average of 20 payers each, according to CMS.

“Right now, [physicians are] inundated with requests, and it takes a lot of time to update this stuff,” said David Zetter, a practice management consultant in Mechanicsburg, Pa.. “If there were one national repository of this information, that would be a good move.”

CMS envisions the National Directory as a central hub from which payers could obtain the latest provider data, which would be updated through a standardized application programming interface (API). Consequently, the insurers would no longer need to have providers submit this information to them separately.

CMS is soliciting input on what should be included in the directory. It notes that in addition to contact information, insurer directories also include a physicians’ specialties, health plan affiliations, and whether they accept new patients.

CMS’ 60-day public comment period ends Dec. 6. After that, the agency will decide what steps to take if it is decided that CMS has the legal authority to create the directory.
 

Terrible track record

In its annual reviews of health plan directories, CMS found that, from 2017 to 2022, only 47% of provider entries were complete. Only 73% of the providers could be matched to published directories. And only 28% of the provider names, addresses, and specialties in the directories matched those in the National Provider Identifier (NPI) registry.

Many of the mistakes in provider directories stem from errors made by practice staff, who have many other duties besides updating directory data. Yet an astonishing amount of time and effort is devoted to this task. A 2019 survey found that physician practices spend $2.76 billion annually on directory maintenance, or nearly $1000 per month per practice, on average.

The Council for Affordable Quality Healthcare, which conducted the survey, estimated that placing all directory data collection on a single platform could save the average practice $4,746 per year. For all practices in the United States, that works out to about $1.1 billion annually, CAQH said.
 

Pros and cons of national directory

For all the money spent on maintaining provider directories, consumers don’t use them very much. According to a 2021 Press Ganey survey, fewer than 5% of consumers seeking a primary care doctor get their information from an insurer or a benefits manager. About half search the internet first, and 24% seek a referral from a physician.

A national provider directory would be useful only if it were done right, Mr. Zetter said. Citing the inaccuracy and incompleteness of health plan directories, he said it was likely that a national directory would have similar problems. Data entered by practice staff would have to be automatically validated, perhaps through use of some kind of AI algorithm.
 

Effect on coordination of care

Mr. Zetter doubts the directory could improve care coordination, because primary care doctors usually refer patients to specialists they already know.

But Julia Adler-Milstein, PhD, professor of medicine and director of the Center for Clinical Informatics at the University of California, San Francisco, said that a national directory could improve communications among providers when patients select specialists outside of their primary care physician’s referral network.

“Especially if it’s not an established referral relationship, that’s where a national directory would be helpful, not only to locate the physicians but also to understand their preferences in how they’d like to receive information,” she said in an interview.

Dr. Adler-Milstein worries less than Mr. Zetter does about the challenge of ensuring the accuracy of data in the directory. She pointed out that the National Plan and Provider Enumeration System, which includes the NPI registry, has done a good job of validating provider name, address, and specialty information.

Dr. Adler-Milstein is more concerned about whether the proposed directory would address physician preferences as to how they wish to receive information. For example, while some physicians may prefer to be contacted directly, others may prefer or are required to communicate through their practices or health systems.
 

Efficiency in data exchange

The API used by the proposed directory would be based on the Fast Health Interoperability Resources standard that all electronic health record vendors must now include in their products. That raises the question of whether communications using contact information from the directory would be sent through a secure email system or through integrated EHR systems, Dr. Adler-Milstein said.

“I’m not sure whether the directory could support that [integration],” she said. “If it focuses on the concept of secure email exchange, that’s a relatively inefficient way of doing it,” because providers want clinical messages to pop up in their EHR workflow rather than their inboxes.

Nevertheless, Dr. Milstein-Adler added, the directory “would clearly take a lot of today’s manual work out of the system. I think organizations like UCSF would be very motivated to support the directory, knowing that people were going to a single source to find the updated information, including preferences in how we’d like people to communicate with us. There would be a lot of efficiency reasons for organizations to use this national directory.”

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

When a consumer uses a health plan provider directory to look up a physician, there’s a high probability that the entry for that doctor is incomplete or inaccurate. The Centers for Medicare & Medicaid Services would like to change that by creating a National Directory of Healthcare Providers and Services, which the agency believes would be more valuable to consumers.

In asking for public comments on whether and how it should establish the directory, CMS argues that this data repository would help patients locate physicians and could help with care coordination, health information exchange, and public health data reporting.

However, it’s not clear that such a directory would be any better than current insurance company listings or that people would use it. But a national directory could benefit physician practices by reducing their administrative work, according to observers.

In requesting public comment on the proposed national directory, CMS explains that provider organizations face “redundant and burdensome reporting requirements to multiple databases.” The directory could greatly reduce this challenge by requiring health care organizations to report provider information to a single database. Currently, physician practices have to submit these data to an average of 20 payers each, according to CMS.

“Right now, [physicians are] inundated with requests, and it takes a lot of time to update this stuff,” said David Zetter, a practice management consultant in Mechanicsburg, Pa.. “If there were one national repository of this information, that would be a good move.”

CMS envisions the National Directory as a central hub from which payers could obtain the latest provider data, which would be updated through a standardized application programming interface (API). Consequently, the insurers would no longer need to have providers submit this information to them separately.

CMS is soliciting input on what should be included in the directory. It notes that in addition to contact information, insurer directories also include a physicians’ specialties, health plan affiliations, and whether they accept new patients.

CMS’ 60-day public comment period ends Dec. 6. After that, the agency will decide what steps to take if it is decided that CMS has the legal authority to create the directory.
 

Terrible track record

In its annual reviews of health plan directories, CMS found that, from 2017 to 2022, only 47% of provider entries were complete. Only 73% of the providers could be matched to published directories. And only 28% of the provider names, addresses, and specialties in the directories matched those in the National Provider Identifier (NPI) registry.

Many of the mistakes in provider directories stem from errors made by practice staff, who have many other duties besides updating directory data. Yet an astonishing amount of time and effort is devoted to this task. A 2019 survey found that physician practices spend $2.76 billion annually on directory maintenance, or nearly $1000 per month per practice, on average.

The Council for Affordable Quality Healthcare, which conducted the survey, estimated that placing all directory data collection on a single platform could save the average practice $4,746 per year. For all practices in the United States, that works out to about $1.1 billion annually, CAQH said.
 

Pros and cons of national directory

For all the money spent on maintaining provider directories, consumers don’t use them very much. According to a 2021 Press Ganey survey, fewer than 5% of consumers seeking a primary care doctor get their information from an insurer or a benefits manager. About half search the internet first, and 24% seek a referral from a physician.

A national provider directory would be useful only if it were done right, Mr. Zetter said. Citing the inaccuracy and incompleteness of health plan directories, he said it was likely that a national directory would have similar problems. Data entered by practice staff would have to be automatically validated, perhaps through use of some kind of AI algorithm.
 

Effect on coordination of care

Mr. Zetter doubts the directory could improve care coordination, because primary care doctors usually refer patients to specialists they already know.

But Julia Adler-Milstein, PhD, professor of medicine and director of the Center for Clinical Informatics at the University of California, San Francisco, said that a national directory could improve communications among providers when patients select specialists outside of their primary care physician’s referral network.

“Especially if it’s not an established referral relationship, that’s where a national directory would be helpful, not only to locate the physicians but also to understand their preferences in how they’d like to receive information,” she said in an interview.

Dr. Adler-Milstein worries less than Mr. Zetter does about the challenge of ensuring the accuracy of data in the directory. She pointed out that the National Plan and Provider Enumeration System, which includes the NPI registry, has done a good job of validating provider name, address, and specialty information.

Dr. Adler-Milstein is more concerned about whether the proposed directory would address physician preferences as to how they wish to receive information. For example, while some physicians may prefer to be contacted directly, others may prefer or are required to communicate through their practices or health systems.
 

Efficiency in data exchange

The API used by the proposed directory would be based on the Fast Health Interoperability Resources standard that all electronic health record vendors must now include in their products. That raises the question of whether communications using contact information from the directory would be sent through a secure email system or through integrated EHR systems, Dr. Adler-Milstein said.

“I’m not sure whether the directory could support that [integration],” she said. “If it focuses on the concept of secure email exchange, that’s a relatively inefficient way of doing it,” because providers want clinical messages to pop up in their EHR workflow rather than their inboxes.

Nevertheless, Dr. Milstein-Adler added, the directory “would clearly take a lot of today’s manual work out of the system. I think organizations like UCSF would be very motivated to support the directory, knowing that people were going to a single source to find the updated information, including preferences in how we’d like people to communicate with us. There would be a lot of efficiency reasons for organizations to use this national directory.”

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

When a consumer uses a health plan provider directory to look up a physician, there’s a high probability that the entry for that doctor is incomplete or inaccurate. The Centers for Medicare & Medicaid Services would like to change that by creating a National Directory of Healthcare Providers and Services, which the agency believes would be more valuable to consumers.

In asking for public comments on whether and how it should establish the directory, CMS argues that this data repository would help patients locate physicians and could help with care coordination, health information exchange, and public health data reporting.

However, it’s not clear that such a directory would be any better than current insurance company listings or that people would use it. But a national directory could benefit physician practices by reducing their administrative work, according to observers.

In requesting public comment on the proposed national directory, CMS explains that provider organizations face “redundant and burdensome reporting requirements to multiple databases.” The directory could greatly reduce this challenge by requiring health care organizations to report provider information to a single database. Currently, physician practices have to submit these data to an average of 20 payers each, according to CMS.

“Right now, [physicians are] inundated with requests, and it takes a lot of time to update this stuff,” said David Zetter, a practice management consultant in Mechanicsburg, Pa.. “If there were one national repository of this information, that would be a good move.”

CMS envisions the National Directory as a central hub from which payers could obtain the latest provider data, which would be updated through a standardized application programming interface (API). Consequently, the insurers would no longer need to have providers submit this information to them separately.

CMS is soliciting input on what should be included in the directory. It notes that in addition to contact information, insurer directories also include a physicians’ specialties, health plan affiliations, and whether they accept new patients.

CMS’ 60-day public comment period ends Dec. 6. After that, the agency will decide what steps to take if it is decided that CMS has the legal authority to create the directory.
 

Terrible track record

In its annual reviews of health plan directories, CMS found that, from 2017 to 2022, only 47% of provider entries were complete. Only 73% of the providers could be matched to published directories. And only 28% of the provider names, addresses, and specialties in the directories matched those in the National Provider Identifier (NPI) registry.

Many of the mistakes in provider directories stem from errors made by practice staff, who have many other duties besides updating directory data. Yet an astonishing amount of time and effort is devoted to this task. A 2019 survey found that physician practices spend $2.76 billion annually on directory maintenance, or nearly $1000 per month per practice, on average.

The Council for Affordable Quality Healthcare, which conducted the survey, estimated that placing all directory data collection on a single platform could save the average practice $4,746 per year. For all practices in the United States, that works out to about $1.1 billion annually, CAQH said.
 

Pros and cons of national directory

For all the money spent on maintaining provider directories, consumers don’t use them very much. According to a 2021 Press Ganey survey, fewer than 5% of consumers seeking a primary care doctor get their information from an insurer or a benefits manager. About half search the internet first, and 24% seek a referral from a physician.

A national provider directory would be useful only if it were done right, Mr. Zetter said. Citing the inaccuracy and incompleteness of health plan directories, he said it was likely that a national directory would have similar problems. Data entered by practice staff would have to be automatically validated, perhaps through use of some kind of AI algorithm.
 

Effect on coordination of care

Mr. Zetter doubts the directory could improve care coordination, because primary care doctors usually refer patients to specialists they already know.

But Julia Adler-Milstein, PhD, professor of medicine and director of the Center for Clinical Informatics at the University of California, San Francisco, said that a national directory could improve communications among providers when patients select specialists outside of their primary care physician’s referral network.

“Especially if it’s not an established referral relationship, that’s where a national directory would be helpful, not only to locate the physicians but also to understand their preferences in how they’d like to receive information,” she said in an interview.

Dr. Adler-Milstein worries less than Mr. Zetter does about the challenge of ensuring the accuracy of data in the directory. She pointed out that the National Plan and Provider Enumeration System, which includes the NPI registry, has done a good job of validating provider name, address, and specialty information.

Dr. Adler-Milstein is more concerned about whether the proposed directory would address physician preferences as to how they wish to receive information. For example, while some physicians may prefer to be contacted directly, others may prefer or are required to communicate through their practices or health systems.
 

Efficiency in data exchange

The API used by the proposed directory would be based on the Fast Health Interoperability Resources standard that all electronic health record vendors must now include in their products. That raises the question of whether communications using contact information from the directory would be sent through a secure email system or through integrated EHR systems, Dr. Adler-Milstein said.

“I’m not sure whether the directory could support that [integration],” she said. “If it focuses on the concept of secure email exchange, that’s a relatively inefficient way of doing it,” because providers want clinical messages to pop up in their EHR workflow rather than their inboxes.

Nevertheless, Dr. Milstein-Adler added, the directory “would clearly take a lot of today’s manual work out of the system. I think organizations like UCSF would be very motivated to support the directory, knowing that people were going to a single source to find the updated information, including preferences in how we’d like people to communicate with us. There would be a lot of efficiency reasons for organizations to use this national directory.”

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

Expanding eligibility for active surveillance in low-risk papillary thyroid cancer appears to be safe, a new prospective trial indicates.

Researchers found that doubling the limits for tumor size to 2 cm and nearly doubling the limits for tumor growth in low-risk papillary thyroid cancer showed no increased risk of adverse outcomes or mortality for patients undergoing active surveillance versus surgery.

“The results of this nonrandomized controlled trial suggest the basis of a more permissive strategy for thyroid cancer management, strengthening the evidence for active surveillance and broadening potential candidacy to most diagnosed thyroid cancers,” the authors conclude. “By extending [tumor] size/growth limits, these study results potentially broaden the potential candidacy for active surveillance and reduce the likelihood of surgery by lengthening the window of observation.”

However, “the expanded parameters are quite controversial,” first author Allen S. Ho, MD, of Cedars-Sinai Medical Center, Los Angeles, told this news organization. Prior studies have only examined tumor size limits up to 1 cm and “clinicians rarely recommend active surveillance up to 2 cm,” Dr. Ho noted. “As far as we know, Cedars-Sinai is the only place that will consider it.”

In addition, the ultimate decision surrounding active surveillance versus surgery may depend on the patient’s level of anxiety, researchers found.

The research was published in JAMA Oncology.

The potential to expand criteria for thyroid cancer active surveillance comes amid ongoing concerns surrounding overtreatment. Advances in technology have led to increased detection of small, often indolent thyroid cancers that can likely be monitored safely through active surveillance but may present decision-making challenges for clinicians about whether to treat or watch and wait.

Similar challenges in prostate cancer have been addressed with tiered risk stratification, but such guidelines have not been as firmly established in thyroid cancer.

Guidelines from the American Thyroid Association in 2015 suggest active surveillance as an alternative for very low-risk tumors; however, studies in general have recommended the approach for initial tumor sizes of only up to 1 cm and with growth of less than 3 mm. And overall, active surveillance has not been broadly adopted as an option in thyroid cancer, the authors explained.

To determine if criteria for active surveillance can be safely expanded to tumors up to 2 cm and for those with growth up to 5 mm, Dr. Ho and colleagues compared outcomes among 222 patients with Bethesda 5 or 6 nodules of 2 cm or smaller who received either active surveillance or immediate surgery.

The patients were recruited from Cedars-Sinai Medical Center between 2014 and 2021. Patients were a median 46.8 years old; 76% were female.

The median size of tumors was 11 mm, with about 60% representing larger tumors (10.1 to 20 mm) and 20.6% measuring 15.1 to 20 mm.

About half of patients (n = 112) chose active surveillance. The median size of tumors in this group was smaller than those in the surgery group (10.1 mm vs. 12 mm). Tumor growth exceeded 5 mm in 3.6% of cases, and tumor volume increases of more than 100% occurred in 7% of cases.

With a mean follow-up of 37 months, 90% (101) of those on active surveillance continued with that approach. Notably, 41% of these patients demonstrated a decrease in tumor size, and no cases of metastatic lymph nodes or distant metastases emerged.

Of the 110 patients who elected to undergo immediate surgery, 19% (21) had equivocal-risk or undetermined features on final pathology, but the disease severity for these patients remained classified as stage I thyroid cancer.

The disease-specific survival and overall survival rates were the same in both groups, at 100%.

Although a general concern is that larger tumors may be more likely to grow, it’s important to note that “papillary thyroid cancer exists in a spectrum,” Dr. Ho explained. What that means is “some smaller cancers grow quickly, while some larger cancers are stable for decades.”

“We believe that a 1 cm cutoff is arbitrary,” Dr. Ho said, adding that 2 cm cancers that grow will still be within the therapeutic window for safe surgery.

However, a key factor in treatment decisions is patient fear. The authors also looked at the anxiety levels in both groups, using the 18-item Thyroid Cancer Modified Anxiety Scale.

Among the 59 patients who participated, those who chose immediate surgery had significantly higher baseline anxiety levels, compared with those who opted for active surveillance. Notably, these higher rates of anxiety endured over time, including after the intervention.

“It is unsurprising that patients choosing surgery possess a higher baseline level of worry,” Dr. Ho said. “However, we were astonished to find that such patients retained high levels of worry, even after surgery and presumed cure of their cancer.”

The role of the anxiety, however, underscores the need for clinicians to be mindful of the often profound psychological impacts of cancer, even low-risk disease.

“We always encourage clinicians to educate patients on active surveillance, especially as it gets highlighted more in official guidelines,” Dr. Ho noted. “However, we certainly acknowledge that cancer is a life-changing diagnosis, and the term can carry enormous psychological weight.”

The authors also acknowledged several study limitations, including the single-center, nonrandomized design and small sample size, and urge follow-up analyses to “independently verify our findings.”

In an accompanying editorial, Andrea L. Merrill, MD, from Boston Medical Center, and Priya H. Dedhia, MD, PhD, with Ohio State University Wexner Medical Center, said the findings have important clinical implications.

“This provocative study not only lays the groundwork for expanding active surveillance criteria for low-risk papillary thyroid cancer but may also improve use of current American Thyroid Association guidelines for active surveillance by demonstrating that use of active surveillance for Bethesda 5 or 6 nodules 20 mm or smaller was not associated with an increase in staging or disease-specific mortality,” they write.

The study is also notable for being among the first to assess the role of patient anxiety in the selection of immediate surgery versus active surveillance, Dr. Merrill and Dr. Dedhia added.

“These findings imply that patient anxiety should be an essential component of shared decision-making and selection of strategies for low-risk papillary thyroid cancer,” they say.

The study authors and editorial authors report no relevant financial relationships.

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

Expanding eligibility for active surveillance in low-risk papillary thyroid cancer appears to be safe, a new prospective trial indicates.

Researchers found that doubling the limits for tumor size to 2 cm and nearly doubling the limits for tumor growth in low-risk papillary thyroid cancer showed no increased risk of adverse outcomes or mortality for patients undergoing active surveillance versus surgery.

“The results of this nonrandomized controlled trial suggest the basis of a more permissive strategy for thyroid cancer management, strengthening the evidence for active surveillance and broadening potential candidacy to most diagnosed thyroid cancers,” the authors conclude. “By extending [tumor] size/growth limits, these study results potentially broaden the potential candidacy for active surveillance and reduce the likelihood of surgery by lengthening the window of observation.”

However, “the expanded parameters are quite controversial,” first author Allen S. Ho, MD, of Cedars-Sinai Medical Center, Los Angeles, told this news organization. Prior studies have only examined tumor size limits up to 1 cm and “clinicians rarely recommend active surveillance up to 2 cm,” Dr. Ho noted. “As far as we know, Cedars-Sinai is the only place that will consider it.”

In addition, the ultimate decision surrounding active surveillance versus surgery may depend on the patient’s level of anxiety, researchers found.

The research was published in JAMA Oncology.

The potential to expand criteria for thyroid cancer active surveillance comes amid ongoing concerns surrounding overtreatment. Advances in technology have led to increased detection of small, often indolent thyroid cancers that can likely be monitored safely through active surveillance but may present decision-making challenges for clinicians about whether to treat or watch and wait.

Similar challenges in prostate cancer have been addressed with tiered risk stratification, but such guidelines have not been as firmly established in thyroid cancer.

Guidelines from the American Thyroid Association in 2015 suggest active surveillance as an alternative for very low-risk tumors; however, studies in general have recommended the approach for initial tumor sizes of only up to 1 cm and with growth of less than 3 mm. And overall, active surveillance has not been broadly adopted as an option in thyroid cancer, the authors explained.

To determine if criteria for active surveillance can be safely expanded to tumors up to 2 cm and for those with growth up to 5 mm, Dr. Ho and colleagues compared outcomes among 222 patients with Bethesda 5 or 6 nodules of 2 cm or smaller who received either active surveillance or immediate surgery.

The patients were recruited from Cedars-Sinai Medical Center between 2014 and 2021. Patients were a median 46.8 years old; 76% were female.

The median size of tumors was 11 mm, with about 60% representing larger tumors (10.1 to 20 mm) and 20.6% measuring 15.1 to 20 mm.

About half of patients (n = 112) chose active surveillance. The median size of tumors in this group was smaller than those in the surgery group (10.1 mm vs. 12 mm). Tumor growth exceeded 5 mm in 3.6% of cases, and tumor volume increases of more than 100% occurred in 7% of cases.

With a mean follow-up of 37 months, 90% (101) of those on active surveillance continued with that approach. Notably, 41% of these patients demonstrated a decrease in tumor size, and no cases of metastatic lymph nodes or distant metastases emerged.

Of the 110 patients who elected to undergo immediate surgery, 19% (21) had equivocal-risk or undetermined features on final pathology, but the disease severity for these patients remained classified as stage I thyroid cancer.

The disease-specific survival and overall survival rates were the same in both groups, at 100%.

Although a general concern is that larger tumors may be more likely to grow, it’s important to note that “papillary thyroid cancer exists in a spectrum,” Dr. Ho explained. What that means is “some smaller cancers grow quickly, while some larger cancers are stable for decades.”

“We believe that a 1 cm cutoff is arbitrary,” Dr. Ho said, adding that 2 cm cancers that grow will still be within the therapeutic window for safe surgery.

However, a key factor in treatment decisions is patient fear. The authors also looked at the anxiety levels in both groups, using the 18-item Thyroid Cancer Modified Anxiety Scale.

Among the 59 patients who participated, those who chose immediate surgery had significantly higher baseline anxiety levels, compared with those who opted for active surveillance. Notably, these higher rates of anxiety endured over time, including after the intervention.

“It is unsurprising that patients choosing surgery possess a higher baseline level of worry,” Dr. Ho said. “However, we were astonished to find that such patients retained high levels of worry, even after surgery and presumed cure of their cancer.”

The role of the anxiety, however, underscores the need for clinicians to be mindful of the often profound psychological impacts of cancer, even low-risk disease.

“We always encourage clinicians to educate patients on active surveillance, especially as it gets highlighted more in official guidelines,” Dr. Ho noted. “However, we certainly acknowledge that cancer is a life-changing diagnosis, and the term can carry enormous psychological weight.”

The authors also acknowledged several study limitations, including the single-center, nonrandomized design and small sample size, and urge follow-up analyses to “independently verify our findings.”

In an accompanying editorial, Andrea L. Merrill, MD, from Boston Medical Center, and Priya H. Dedhia, MD, PhD, with Ohio State University Wexner Medical Center, said the findings have important clinical implications.

“This provocative study not only lays the groundwork for expanding active surveillance criteria for low-risk papillary thyroid cancer but may also improve use of current American Thyroid Association guidelines for active surveillance by demonstrating that use of active surveillance for Bethesda 5 or 6 nodules 20 mm or smaller was not associated with an increase in staging or disease-specific mortality,” they write.

The study is also notable for being among the first to assess the role of patient anxiety in the selection of immediate surgery versus active surveillance, Dr. Merrill and Dr. Dedhia added.

“These findings imply that patient anxiety should be an essential component of shared decision-making and selection of strategies for low-risk papillary thyroid cancer,” they say.

The study authors and editorial authors report no relevant financial relationships.

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

Expanding eligibility for active surveillance in low-risk papillary thyroid cancer appears to be safe, a new prospective trial indicates.

Researchers found that doubling the limits for tumor size to 2 cm and nearly doubling the limits for tumor growth in low-risk papillary thyroid cancer showed no increased risk of adverse outcomes or mortality for patients undergoing active surveillance versus surgery.

“The results of this nonrandomized controlled trial suggest the basis of a more permissive strategy for thyroid cancer management, strengthening the evidence for active surveillance and broadening potential candidacy to most diagnosed thyroid cancers,” the authors conclude. “By extending [tumor] size/growth limits, these study results potentially broaden the potential candidacy for active surveillance and reduce the likelihood of surgery by lengthening the window of observation.”

However, “the expanded parameters are quite controversial,” first author Allen S. Ho, MD, of Cedars-Sinai Medical Center, Los Angeles, told this news organization. Prior studies have only examined tumor size limits up to 1 cm and “clinicians rarely recommend active surveillance up to 2 cm,” Dr. Ho noted. “As far as we know, Cedars-Sinai is the only place that will consider it.”

In addition, the ultimate decision surrounding active surveillance versus surgery may depend on the patient’s level of anxiety, researchers found.

The research was published in JAMA Oncology.

The potential to expand criteria for thyroid cancer active surveillance comes amid ongoing concerns surrounding overtreatment. Advances in technology have led to increased detection of small, often indolent thyroid cancers that can likely be monitored safely through active surveillance but may present decision-making challenges for clinicians about whether to treat or watch and wait.

Similar challenges in prostate cancer have been addressed with tiered risk stratification, but such guidelines have not been as firmly established in thyroid cancer.

Guidelines from the American Thyroid Association in 2015 suggest active surveillance as an alternative for very low-risk tumors; however, studies in general have recommended the approach for initial tumor sizes of only up to 1 cm and with growth of less than 3 mm. And overall, active surveillance has not been broadly adopted as an option in thyroid cancer, the authors explained.

To determine if criteria for active surveillance can be safely expanded to tumors up to 2 cm and for those with growth up to 5 mm, Dr. Ho and colleagues compared outcomes among 222 patients with Bethesda 5 or 6 nodules of 2 cm or smaller who received either active surveillance or immediate surgery.

The patients were recruited from Cedars-Sinai Medical Center between 2014 and 2021. Patients were a median 46.8 years old; 76% were female.

The median size of tumors was 11 mm, with about 60% representing larger tumors (10.1 to 20 mm) and 20.6% measuring 15.1 to 20 mm.

About half of patients (n = 112) chose active surveillance. The median size of tumors in this group was smaller than those in the surgery group (10.1 mm vs. 12 mm). Tumor growth exceeded 5 mm in 3.6% of cases, and tumor volume increases of more than 100% occurred in 7% of cases.

With a mean follow-up of 37 months, 90% (101) of those on active surveillance continued with that approach. Notably, 41% of these patients demonstrated a decrease in tumor size, and no cases of metastatic lymph nodes or distant metastases emerged.

Of the 110 patients who elected to undergo immediate surgery, 19% (21) had equivocal-risk or undetermined features on final pathology, but the disease severity for these patients remained classified as stage I thyroid cancer.

The disease-specific survival and overall survival rates were the same in both groups, at 100%.

Although a general concern is that larger tumors may be more likely to grow, it’s important to note that “papillary thyroid cancer exists in a spectrum,” Dr. Ho explained. What that means is “some smaller cancers grow quickly, while some larger cancers are stable for decades.”

“We believe that a 1 cm cutoff is arbitrary,” Dr. Ho said, adding that 2 cm cancers that grow will still be within the therapeutic window for safe surgery.

However, a key factor in treatment decisions is patient fear. The authors also looked at the anxiety levels in both groups, using the 18-item Thyroid Cancer Modified Anxiety Scale.

Among the 59 patients who participated, those who chose immediate surgery had significantly higher baseline anxiety levels, compared with those who opted for active surveillance. Notably, these higher rates of anxiety endured over time, including after the intervention.

“It is unsurprising that patients choosing surgery possess a higher baseline level of worry,” Dr. Ho said. “However, we were astonished to find that such patients retained high levels of worry, even after surgery and presumed cure of their cancer.”

The role of the anxiety, however, underscores the need for clinicians to be mindful of the often profound psychological impacts of cancer, even low-risk disease.

“We always encourage clinicians to educate patients on active surveillance, especially as it gets highlighted more in official guidelines,” Dr. Ho noted. “However, we certainly acknowledge that cancer is a life-changing diagnosis, and the term can carry enormous psychological weight.”

The authors also acknowledged several study limitations, including the single-center, nonrandomized design and small sample size, and urge follow-up analyses to “independently verify our findings.”

In an accompanying editorial, Andrea L. Merrill, MD, from Boston Medical Center, and Priya H. Dedhia, MD, PhD, with Ohio State University Wexner Medical Center, said the findings have important clinical implications.

“This provocative study not only lays the groundwork for expanding active surveillance criteria for low-risk papillary thyroid cancer but may also improve use of current American Thyroid Association guidelines for active surveillance by demonstrating that use of active surveillance for Bethesda 5 or 6 nodules 20 mm or smaller was not associated with an increase in staging or disease-specific mortality,” they write.

The study is also notable for being among the first to assess the role of patient anxiety in the selection of immediate surgery versus active surveillance, Dr. Merrill and Dr. Dedhia added.

“These findings imply that patient anxiety should be an essential component of shared decision-making and selection of strategies for low-risk papillary thyroid cancer,” they say.

The study authors and editorial authors report no relevant financial relationships.

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