PHILADELPHIA – Opening the door to transformational change can be as simple as opening a door.

Gregory Twachtman/MDedge News

At least one physician can attest to this.

Priya Radhakrishnan, MD, chief academic officer at HonorHealth Medical Group, Phoenix, described one of her earliest successes in working on the Transforming Clinical Practice Initiative as her literal and figurative opening of the door between a behavioral health office and a physician health office.

In her example, which she presented in a panel on transformational change at the annual meeting of the American College of Physicians, both the behavioral health office and the physician office coordinated to have the same Medicaid patients. Because of that, when the behavioral health specialist learned of a physical condition, a “warm hand-off” was made simply by walking the patient into the doctor’s office, she said.

Transformational changes in the delivery of health care can come from events and opportunities within your medical practice. And your practice data can be the tools that guide you to make the change happen, noted Dr. Radhakrishnan and her copanelists, during the April 12 session. The panelists focused their presentation on lessons learned from the ongoing Transforming Clinical Practice Initiative, a test project of the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation. The project is providing assistance to physicians and practices looking to transform their organizations into using value-based care delivery models.

“I think most of us don’t realize how much power we hold over the ability to change health care within our neighborhood,” said Thomas Spain, MD, of Vanderbilt University Medical Center, Nashville, Tenn., during his presentation. “[We] have been lulled into this idea that health care will change ... when someone in Washington, D.C., finally makes a change.”

Actually, specific events in a single practice typically drive changes, he said. Most physicians who made these changes “really had very little interest in [practice changes]; then something would happen. It was a patient experience that they had, a family experience, a new program that came along” that made them realize there is an opportunity here for a physician to take the lead and make a change.

And, invariably, those physicians discovered “new satisfaction in their work through the process ... [their] practices looked very different at the end of the project,” Dr. Spain noted.

The other component to the success was looking differently at data to assure continuous data-driven quality improvement, said copanelist M. Carol Greenlee, MD, an endocrinologist and chair and counsel of subspecialty societies at ACP.

Data aren’t just about “being judged [and] not getting penalized,” she said. Data need to be viewed as a tool to really help understand the needs of the patient and the population.

Change makers “had to [ask], ‘For my population, how do I reduce admissions, what are the unnecessary tests my patients are getting, what are the unnecessary procedures?’ ” she said. Through the Transforming Clinical Practice Initiative, “we are teaching [participants] how to use data to show their value to payers ... and to find their voice in sharing their value.”

Some of the aims of the program included building solutions that were scalable, reducing unnecessary hospital admissions, generating $1 billion to $4 billion in savings, and transitioning 75% of practices completing the program to alternative payment models.

Dr. Spain noted that something as simple as moving the “if this is a medical emergency” disclaimer to the end of the outbound message at the physician office could help reduce trips to the emergency department. This could instead bring the patient to the office.

“Start small,” Dr. Radhakrishnan advised. “Value and quality freaks all of us out.”

Target small successes that can be built upon.

“Care delivery is the final mile,” Dr. Greenlee added. “We have all this medical knowledge, all the science and clinical research, and we know what to do with our guidelines, but if we don’t have care delivery, that final mile of [improving] ... the health of our patients, all of this is for naught.”

[email protected]

PHILADELPHIA – Opening the door to transformational change can be as simple as opening a door.

Gregory Twachtman/MDedge News

At least one physician can attest to this.

Priya Radhakrishnan, MD, chief academic officer at HonorHealth Medical Group, Phoenix, described one of her earliest successes in working on the Transforming Clinical Practice Initiative as her literal and figurative opening of the door between a behavioral health office and a physician health office.

In her example, which she presented in a panel on transformational change at the annual meeting of the American College of Physicians, both the behavioral health office and the physician office coordinated to have the same Medicaid patients. Because of that, when the behavioral health specialist learned of a physical condition, a “warm hand-off” was made simply by walking the patient into the doctor’s office, she said.

Transformational changes in the delivery of health care can come from events and opportunities within your medical practice. And your practice data can be the tools that guide you to make the change happen, noted Dr. Radhakrishnan and her copanelists, during the April 12 session. The panelists focused their presentation on lessons learned from the ongoing Transforming Clinical Practice Initiative, a test project of the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation. The project is providing assistance to physicians and practices looking to transform their organizations into using value-based care delivery models.

“I think most of us don’t realize how much power we hold over the ability to change health care within our neighborhood,” said Thomas Spain, MD, of Vanderbilt University Medical Center, Nashville, Tenn., during his presentation. “[We] have been lulled into this idea that health care will change ... when someone in Washington, D.C., finally makes a change.”

Actually, specific events in a single practice typically drive changes, he said. Most physicians who made these changes “really had very little interest in [practice changes]; then something would happen. It was a patient experience that they had, a family experience, a new program that came along” that made them realize there is an opportunity here for a physician to take the lead and make a change.

And, invariably, those physicians discovered “new satisfaction in their work through the process ... [their] practices looked very different at the end of the project,” Dr. Spain noted.

The other component to the success was looking differently at data to assure continuous data-driven quality improvement, said copanelist M. Carol Greenlee, MD, an endocrinologist and chair and counsel of subspecialty societies at ACP.

Data aren’t just about “being judged [and] not getting penalized,” she said. Data need to be viewed as a tool to really help understand the needs of the patient and the population.

Change makers “had to [ask], ‘For my population, how do I reduce admissions, what are the unnecessary tests my patients are getting, what are the unnecessary procedures?’ ” she said. Through the Transforming Clinical Practice Initiative, “we are teaching [participants] how to use data to show their value to payers ... and to find their voice in sharing their value.”

Some of the aims of the program included building solutions that were scalable, reducing unnecessary hospital admissions, generating $1 billion to $4 billion in savings, and transitioning 75% of practices completing the program to alternative payment models.

Dr. Spain noted that something as simple as moving the “if this is a medical emergency” disclaimer to the end of the outbound message at the physician office could help reduce trips to the emergency department. This could instead bring the patient to the office.

“Start small,” Dr. Radhakrishnan advised. “Value and quality freaks all of us out.”

Target small successes that can be built upon.

“Care delivery is the final mile,” Dr. Greenlee added. “We have all this medical knowledge, all the science and clinical research, and we know what to do with our guidelines, but if we don’t have care delivery, that final mile of [improving] ... the health of our patients, all of this is for naught.”

[email protected]

PHILADELPHIA – Opening the door to transformational change can be as simple as opening a door.

Gregory Twachtman/MDedge News

At least one physician can attest to this.

Priya Radhakrishnan, MD, chief academic officer at HonorHealth Medical Group, Phoenix, described one of her earliest successes in working on the Transforming Clinical Practice Initiative as her literal and figurative opening of the door between a behavioral health office and a physician health office.

In her example, which she presented in a panel on transformational change at the annual meeting of the American College of Physicians, both the behavioral health office and the physician office coordinated to have the same Medicaid patients. Because of that, when the behavioral health specialist learned of a physical condition, a “warm hand-off” was made simply by walking the patient into the doctor’s office, she said.

Transformational changes in the delivery of health care can come from events and opportunities within your medical practice. And your practice data can be the tools that guide you to make the change happen, noted Dr. Radhakrishnan and her copanelists, during the April 12 session. The panelists focused their presentation on lessons learned from the ongoing Transforming Clinical Practice Initiative, a test project of the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation. The project is providing assistance to physicians and practices looking to transform their organizations into using value-based care delivery models.

“I think most of us don’t realize how much power we hold over the ability to change health care within our neighborhood,” said Thomas Spain, MD, of Vanderbilt University Medical Center, Nashville, Tenn., during his presentation. “[We] have been lulled into this idea that health care will change ... when someone in Washington, D.C., finally makes a change.”

Actually, specific events in a single practice typically drive changes, he said. Most physicians who made these changes “really had very little interest in [practice changes]; then something would happen. It was a patient experience that they had, a family experience, a new program that came along” that made them realize there is an opportunity here for a physician to take the lead and make a change.

And, invariably, those physicians discovered “new satisfaction in their work through the process ... [their] practices looked very different at the end of the project,” Dr. Spain noted.

The other component to the success was looking differently at data to assure continuous data-driven quality improvement, said copanelist M. Carol Greenlee, MD, an endocrinologist and chair and counsel of subspecialty societies at ACP.

Data aren’t just about “being judged [and] not getting penalized,” she said. Data need to be viewed as a tool to really help understand the needs of the patient and the population.

Change makers “had to [ask], ‘For my population, how do I reduce admissions, what are the unnecessary tests my patients are getting, what are the unnecessary procedures?’ ” she said. Through the Transforming Clinical Practice Initiative, “we are teaching [participants] how to use data to show their value to payers ... and to find their voice in sharing their value.”

Some of the aims of the program included building solutions that were scalable, reducing unnecessary hospital admissions, generating $1 billion to $4 billion in savings, and transitioning 75% of practices completing the program to alternative payment models.

Dr. Spain noted that something as simple as moving the “if this is a medical emergency” disclaimer to the end of the outbound message at the physician office could help reduce trips to the emergency department. This could instead bring the patient to the office.

“Start small,” Dr. Radhakrishnan advised. “Value and quality freaks all of us out.”

Target small successes that can be built upon.

“Care delivery is the final mile,” Dr. Greenlee added. “We have all this medical knowledge, all the science and clinical research, and we know what to do with our guidelines, but if we don’t have care delivery, that final mile of [improving] ... the health of our patients, all of this is for naught.”

[email protected]

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

NEW ORLEANS – The 2015 American Thyroid Association risk stratification system for patients with differentiated thyroid cancer performed well in a real-world cohort with a high proportion of high-risk patients, according to a study presented at the annual meeting of the Endocrine Society.

“The 2015 ATA Risk Stratification System is an excellent predictor of both persisting disease and survival,” wrote Evert F.S. van Velsen, MD, and his colleagues at Erasmus Medical Center, Rotterdam, the Netherlands, in a poster accompanying the presentation.

Among a group of 236 patients with differentiated thyroid cancer (DTC), Dr. van Velsen and his coauthors looked at how the ATA high-risk criteria influenced patient response to therapy. By the end of the 14-year study period, initial gross extrathyroidal disease extension meant patients were much less likely to have an excellent response (odds ratio, 0.26; P less than .001), and much more likely to have persistent disease (OR, 2.57; P = .001).

Odds of having an excellent response were reduced by having high postoperative thyroglobulin levels (OR, 0.21; P less than .001), and persistent disease was more likely (OR, 2.39; P = .002).

Other high-risk criteria associated with significantly lower odds of excellent response included distant metastases (OR, 0.36), incomplete resection (OR, 0.51), and having follicular thyroid carcinoma (FTC) with extensive vascular invasion (OR, 0.27). All these risk factors also were associated with higher odds of persistent disease.

“Recurrence after no evidence of disease occurred in 14%” of the study population, said Dr. van Velsen and his coauthors, adding, “Clinicians should be aware of the relatively high recurrence risk, even after an excellent response to therapy.”

The study aimed to evaluate the 2015 ATA risk stratification system’s prognostic value in a population that included a relatively large proportion of high-risk DTC patients, to include many FTC patients. This work, they noted, augments previous assessments of the risk stratification system in lower-risk populations.

The authors noted that, in addition to predicting disease recurrence, the risk stratification system also worked as a predictor of disease-specific survival. Patients with structural incomplete response fared the worst, with a survival probability below 0.5 at 200 months on a Kaplan-Meier curve of disease-specific survival. Survival probability remained at 1.0 for patients with excellent response after first therapy and was intermediate for those with indeterminate response and biochemical incomplete response.

Overall mortality was higher in FTC patients. Over the study period, 31 of the 76 FTC patients (41%) died, compared with 39 of the PTC patients (24%; P = .010). In all, 28% of the FTC patients and 18% of the PTC patients died of thyroid cancer, but this difference didn’t reach statistical significance.

The retrospective study included adults with DTC meeting the 2015 ATA high-risk criteria who were diagnosed and/or treated at Erasmus Medical Center over a 13-year span ending in December 2015.

Overall, the investigators found 236 patients meeting inclusion criteria; 160 had papillary thyroid cancer (PTC), and the remaining 76 had FTC. The latter group were significantly older at baseline than PTC patients (64 versus 53 years), and were significantly less likely to undergo neck dissection (22% versus 55%).

In the full cohort, 96 patients (41%) had one high-risk factor, and an additional 74 (31%) had two risk factors. The remaining patients had three or more risk factors.

There was no between-group difference in the likelihood of receiving radioactive iodine treatment, but those with FTC had a lower cumulative radiation dose (195 versus 298 mCi; P less than .001).

More than half of patients (58%) had persistent disease after completing their first therapy. Of these, 51% had structural incomplete response and 7% had biochemical incomplete response. The response was indeterminate for about a quarter of the cohort, and the remaining 17% had an excellent initial response.

By the end of the study period, 55% of patients had persistent disease, and 51% had structural incomplete response (a more likely result for those with FTC than PTC). Just 4% had a biochemical incomplete response, and the response was indeterminate for 16%. Response was judged excellent for 29% of patients.

Dr. van Velsen and his coauthors reported that they had no relevant disclosures.

[email protected]

SOURCE: van Velsen EFS et al. ENDO 2019, Abstract MON-549.

NEW ORLEANS – The 2015 American Thyroid Association risk stratification system for patients with differentiated thyroid cancer performed well in a real-world cohort with a high proportion of high-risk patients, according to a study presented at the annual meeting of the Endocrine Society.

“The 2015 ATA Risk Stratification System is an excellent predictor of both persisting disease and survival,” wrote Evert F.S. van Velsen, MD, and his colleagues at Erasmus Medical Center, Rotterdam, the Netherlands, in a poster accompanying the presentation.

Among a group of 236 patients with differentiated thyroid cancer (DTC), Dr. van Velsen and his coauthors looked at how the ATA high-risk criteria influenced patient response to therapy. By the end of the 14-year study period, initial gross extrathyroidal disease extension meant patients were much less likely to have an excellent response (odds ratio, 0.26; P less than .001), and much more likely to have persistent disease (OR, 2.57; P = .001).

Odds of having an excellent response were reduced by having high postoperative thyroglobulin levels (OR, 0.21; P less than .001), and persistent disease was more likely (OR, 2.39; P = .002).

Other high-risk criteria associated with significantly lower odds of excellent response included distant metastases (OR, 0.36), incomplete resection (OR, 0.51), and having follicular thyroid carcinoma (FTC) with extensive vascular invasion (OR, 0.27). All these risk factors also were associated with higher odds of persistent disease.

“Recurrence after no evidence of disease occurred in 14%” of the study population, said Dr. van Velsen and his coauthors, adding, “Clinicians should be aware of the relatively high recurrence risk, even after an excellent response to therapy.”

The study aimed to evaluate the 2015 ATA risk stratification system’s prognostic value in a population that included a relatively large proportion of high-risk DTC patients, to include many FTC patients. This work, they noted, augments previous assessments of the risk stratification system in lower-risk populations.

The authors noted that, in addition to predicting disease recurrence, the risk stratification system also worked as a predictor of disease-specific survival. Patients with structural incomplete response fared the worst, with a survival probability below 0.5 at 200 months on a Kaplan-Meier curve of disease-specific survival. Survival probability remained at 1.0 for patients with excellent response after first therapy and was intermediate for those with indeterminate response and biochemical incomplete response.

Overall mortality was higher in FTC patients. Over the study period, 31 of the 76 FTC patients (41%) died, compared with 39 of the PTC patients (24%; P = .010). In all, 28% of the FTC patients and 18% of the PTC patients died of thyroid cancer, but this difference didn’t reach statistical significance.

The retrospective study included adults with DTC meeting the 2015 ATA high-risk criteria who were diagnosed and/or treated at Erasmus Medical Center over a 13-year span ending in December 2015.

Overall, the investigators found 236 patients meeting inclusion criteria; 160 had papillary thyroid cancer (PTC), and the remaining 76 had FTC. The latter group were significantly older at baseline than PTC patients (64 versus 53 years), and were significantly less likely to undergo neck dissection (22% versus 55%).

In the full cohort, 96 patients (41%) had one high-risk factor, and an additional 74 (31%) had two risk factors. The remaining patients had three or more risk factors.

There was no between-group difference in the likelihood of receiving radioactive iodine treatment, but those with FTC had a lower cumulative radiation dose (195 versus 298 mCi; P less than .001).

More than half of patients (58%) had persistent disease after completing their first therapy. Of these, 51% had structural incomplete response and 7% had biochemical incomplete response. The response was indeterminate for about a quarter of the cohort, and the remaining 17% had an excellent initial response.

By the end of the study period, 55% of patients had persistent disease, and 51% had structural incomplete response (a more likely result for those with FTC than PTC). Just 4% had a biochemical incomplete response, and the response was indeterminate for 16%. Response was judged excellent for 29% of patients.

Dr. van Velsen and his coauthors reported that they had no relevant disclosures.

[email protected]

SOURCE: van Velsen EFS et al. ENDO 2019, Abstract MON-549.

NEW ORLEANS – The 2015 American Thyroid Association risk stratification system for patients with differentiated thyroid cancer performed well in a real-world cohort with a high proportion of high-risk patients, according to a study presented at the annual meeting of the Endocrine Society.

“The 2015 ATA Risk Stratification System is an excellent predictor of both persisting disease and survival,” wrote Evert F.S. van Velsen, MD, and his colleagues at Erasmus Medical Center, Rotterdam, the Netherlands, in a poster accompanying the presentation.

Among a group of 236 patients with differentiated thyroid cancer (DTC), Dr. van Velsen and his coauthors looked at how the ATA high-risk criteria influenced patient response to therapy. By the end of the 14-year study period, initial gross extrathyroidal disease extension meant patients were much less likely to have an excellent response (odds ratio, 0.26; P less than .001), and much more likely to have persistent disease (OR, 2.57; P = .001).

Odds of having an excellent response were reduced by having high postoperative thyroglobulin levels (OR, 0.21; P less than .001), and persistent disease was more likely (OR, 2.39; P = .002).

Other high-risk criteria associated with significantly lower odds of excellent response included distant metastases (OR, 0.36), incomplete resection (OR, 0.51), and having follicular thyroid carcinoma (FTC) with extensive vascular invasion (OR, 0.27). All these risk factors also were associated with higher odds of persistent disease.

“Recurrence after no evidence of disease occurred in 14%” of the study population, said Dr. van Velsen and his coauthors, adding, “Clinicians should be aware of the relatively high recurrence risk, even after an excellent response to therapy.”

The study aimed to evaluate the 2015 ATA risk stratification system’s prognostic value in a population that included a relatively large proportion of high-risk DTC patients, to include many FTC patients. This work, they noted, augments previous assessments of the risk stratification system in lower-risk populations.

The authors noted that, in addition to predicting disease recurrence, the risk stratification system also worked as a predictor of disease-specific survival. Patients with structural incomplete response fared the worst, with a survival probability below 0.5 at 200 months on a Kaplan-Meier curve of disease-specific survival. Survival probability remained at 1.0 for patients with excellent response after first therapy and was intermediate for those with indeterminate response and biochemical incomplete response.

Overall mortality was higher in FTC patients. Over the study period, 31 of the 76 FTC patients (41%) died, compared with 39 of the PTC patients (24%; P = .010). In all, 28% of the FTC patients and 18% of the PTC patients died of thyroid cancer, but this difference didn’t reach statistical significance.

The retrospective study included adults with DTC meeting the 2015 ATA high-risk criteria who were diagnosed and/or treated at Erasmus Medical Center over a 13-year span ending in December 2015.

Overall, the investigators found 236 patients meeting inclusion criteria; 160 had papillary thyroid cancer (PTC), and the remaining 76 had FTC. The latter group were significantly older at baseline than PTC patients (64 versus 53 years), and were significantly less likely to undergo neck dissection (22% versus 55%).

In the full cohort, 96 patients (41%) had one high-risk factor, and an additional 74 (31%) had two risk factors. The remaining patients had three or more risk factors.

There was no between-group difference in the likelihood of receiving radioactive iodine treatment, but those with FTC had a lower cumulative radiation dose (195 versus 298 mCi; P less than .001).

More than half of patients (58%) had persistent disease after completing their first therapy. Of these, 51% had structural incomplete response and 7% had biochemical incomplete response. The response was indeterminate for about a quarter of the cohort, and the remaining 17% had an excellent initial response.

By the end of the study period, 55% of patients had persistent disease, and 51% had structural incomplete response (a more likely result for those with FTC than PTC). Just 4% had a biochemical incomplete response, and the response was indeterminate for 16%. Response was judged excellent for 29% of patients.

Dr. van Velsen and his coauthors reported that they had no relevant disclosures.

[email protected]

SOURCE: van Velsen EFS et al. ENDO 2019, Abstract MON-549.

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

SAN FRANCISCO – The announcement of a first-ever multicenter randomized trial of ACE inhibitors for the treatment of cognitive impairment in systemic lupus erythematosus patients generated some of the biggest buzz at LUPUS 2019.

Bruce Jancin/MDedge News

“The time has come to implement clinical trials in lupus to see if we can address what is one of the most distressing aspects of the disease to patients,” Betty Diamond, MD, said in announcing the planned trial at an international congress on systemic lupus erythematosus (SLE).

Neuropsychiatric lupus, characterized most often by cognitive impairment, affects 40%-90% of SLE patients, according to various epidemiologic studies. This confusion and memory loss has been shown to be independent of systemic disease activity.

“Cognitive impairment is a very common problem and a very insidious problem in lupus patients,” emphasized Dr. Diamond, professor and head of the Center for Autoimmune Musculoskeletal and Hematopoietic Diseases at the Feinstein Institute for Medical Research in Manhasset, New York.

Dr. Diamond was the recipient of the 2018 Lupus Insight Prize awarded by the Lupus Research Alliance, which is funding the multicenter randomized trial. For the study, roughly 70 SLE patients with cognitive impairment not associated with a focal brain lesion will be randomized to receive a centrally acting ACE inhibitor – captopril was the one she and her coinvestigators have used in their mouse model and preliminary clinical studies – or to a non–centrally acting ACE inhibitor, such as enalapril.

“The clinical trial compares an ACE inhibitor that crosses the blood-brain barrier with one that doesn’t. They both have the same renal protection and systemic anti-inflammatory effects,” explained Dr. Diamond, who is also professor of molecular medicine and of medicine at the Zucker School of Medicine at Hofstra/Northwell, East Garden City, N.Y.

In a recent publication (J Exp Med. 2018 Oct 1;215[10]:2554-66), Dr. Diamond and her coinvestigators presented much of the background work that underpins the upcoming randomized trial. Sixteen years ago, they discovered two anti-DNA antibodies that cross-react with the N-methyl-D-aspartate receptor (NMDAR) and enhance NMDAR signaling. They showed that while the NMDARs are critical in learning and memory, their prolonged stimulation results in a high degree of calcium influx, causing neuronal death. These anti-DNA/anti-NMDAR antibodies, known as DNRAbs, are present at elevated titers in 30%-40% of SLE patients, and in a higher proportion of those with neuropsychiatric lupus.

“Most importantly, DNRAbs are present in the cerebrospinal fluid of patients who have nonfocal CNS manifestations of lupus,” Dr. Diamond said.

She and her coworkers developed a mouse model of cognitive impairment in lupus and utilized it to identify a two-stage model of the pathogenesis of DNRAb-mediated neuropsychiatric lupus. First, a traumatic event such as an infection causes a temporary opening in the blood-brain barrier, allowing the DNRAbs to reach the brain. This results in acute excitotoxic neuronal death. This is followed by a second stage, which entails activation of microglia – known as the macrophages of the CNS – with resultant loss of neuronal dendritic arborization and complexity. In the mouse model, this causes a selective impairment in spatial memory that corresponds well to the spatial memory deficit the investigators documented in DNRAb-positive SLE patients, compared with healthy controls and DNRAb-negative lupus patients.

A key finding in this project, Dr. Diamond continued, was that activated microglia turn out to be critical for dendritic loss. If the microglia are deactivated, regrowth of the dendritic processes occurs. This raises a possibility that attendees at LUPUS 2019 found thrilling: Perhaps the cognitive impairment of neuropsychiatric SLE can be prevented and even reversed by suppressing microglial activation.

Promising work in the field of Alzheimer’s disease suggests that centrally acting ACE inhibitors can indeed suppress microglial activation and actually improve cognition. Dr. Diamond and her colleagues showed this also was the case in their mouse model. Moreover, in a small clinical study they used PET brain imaging to show that captopril reduced the increased glucose uptake and hippocampal hypermetabolism associated with DNRAb-positive neuropsychiatric lupus, an effect maintained through 18 months of follow-up.

“We think DNRAbs contribute to cognitive impairment in SLE patients, but we certainly wouldn’t say that antibodies are the only mechanism. Other investigators have shown that interferon can also do this, and that, like the antibodies, interferon acts through microglial activation. We think that this microglial activation is going to be a general paradigm in cognitive impairment in lupus and in other diseases, so microglia are a very good therapeutic target,” Dr. Diamond said.

The primary outcomes in the forthcoming randomized trial involve PET neuronal imaging. They investigators are hoping to see reduced hippocampal hypermetabolism and suppression of activated microglial cells.

“We’ll see if we’re actually hitting our target. We’re doing neuropsychologic testing, too, but we’re really concentrating on imaging outcomes, because those are objective and have many fewer variables to confound them,” according to Dr. Diamond.

Microglial activation is a current topic of intense research interest within the pharmaceutical industry, she added. If the imaging study is positive, she anticipates drug companies will quickly ramp up and conduct large clinical trials powered to show significant results in terms of neuropsychologic test scores and clinical outcomes.

Dr. Diamond reported having no financial conflicts regarding her work, which has been supported largely by the National Institutes of Health.

[email protected]

SAN FRANCISCO – The announcement of a first-ever multicenter randomized trial of ACE inhibitors for the treatment of cognitive impairment in systemic lupus erythematosus patients generated some of the biggest buzz at LUPUS 2019.

Bruce Jancin/MDedge News

“The time has come to implement clinical trials in lupus to see if we can address what is one of the most distressing aspects of the disease to patients,” Betty Diamond, MD, said in announcing the planned trial at an international congress on systemic lupus erythematosus (SLE).

Neuropsychiatric lupus, characterized most often by cognitive impairment, affects 40%-90% of SLE patients, according to various epidemiologic studies. This confusion and memory loss has been shown to be independent of systemic disease activity.

“Cognitive impairment is a very common problem and a very insidious problem in lupus patients,” emphasized Dr. Diamond, professor and head of the Center for Autoimmune Musculoskeletal and Hematopoietic Diseases at the Feinstein Institute for Medical Research in Manhasset, New York.

Dr. Diamond was the recipient of the 2018 Lupus Insight Prize awarded by the Lupus Research Alliance, which is funding the multicenter randomized trial. For the study, roughly 70 SLE patients with cognitive impairment not associated with a focal brain lesion will be randomized to receive a centrally acting ACE inhibitor – captopril was the one she and her coinvestigators have used in their mouse model and preliminary clinical studies – or to a non–centrally acting ACE inhibitor, such as enalapril.

“The clinical trial compares an ACE inhibitor that crosses the blood-brain barrier with one that doesn’t. They both have the same renal protection and systemic anti-inflammatory effects,” explained Dr. Diamond, who is also professor of molecular medicine and of medicine at the Zucker School of Medicine at Hofstra/Northwell, East Garden City, N.Y.

In a recent publication (J Exp Med. 2018 Oct 1;215[10]:2554-66), Dr. Diamond and her coinvestigators presented much of the background work that underpins the upcoming randomized trial. Sixteen years ago, they discovered two anti-DNA antibodies that cross-react with the N-methyl-D-aspartate receptor (NMDAR) and enhance NMDAR signaling. They showed that while the NMDARs are critical in learning and memory, their prolonged stimulation results in a high degree of calcium influx, causing neuronal death. These anti-DNA/anti-NMDAR antibodies, known as DNRAbs, are present at elevated titers in 30%-40% of SLE patients, and in a higher proportion of those with neuropsychiatric lupus.

“Most importantly, DNRAbs are present in the cerebrospinal fluid of patients who have nonfocal CNS manifestations of lupus,” Dr. Diamond said.

She and her coworkers developed a mouse model of cognitive impairment in lupus and utilized it to identify a two-stage model of the pathogenesis of DNRAb-mediated neuropsychiatric lupus. First, a traumatic event such as an infection causes a temporary opening in the blood-brain barrier, allowing the DNRAbs to reach the brain. This results in acute excitotoxic neuronal death. This is followed by a second stage, which entails activation of microglia – known as the macrophages of the CNS – with resultant loss of neuronal dendritic arborization and complexity. In the mouse model, this causes a selective impairment in spatial memory that corresponds well to the spatial memory deficit the investigators documented in DNRAb-positive SLE patients, compared with healthy controls and DNRAb-negative lupus patients.

A key finding in this project, Dr. Diamond continued, was that activated microglia turn out to be critical for dendritic loss. If the microglia are deactivated, regrowth of the dendritic processes occurs. This raises a possibility that attendees at LUPUS 2019 found thrilling: Perhaps the cognitive impairment of neuropsychiatric SLE can be prevented and even reversed by suppressing microglial activation.

Promising work in the field of Alzheimer’s disease suggests that centrally acting ACE inhibitors can indeed suppress microglial activation and actually improve cognition. Dr. Diamond and her colleagues showed this also was the case in their mouse model. Moreover, in a small clinical study they used PET brain imaging to show that captopril reduced the increased glucose uptake and hippocampal hypermetabolism associated with DNRAb-positive neuropsychiatric lupus, an effect maintained through 18 months of follow-up.

“We think DNRAbs contribute to cognitive impairment in SLE patients, but we certainly wouldn’t say that antibodies are the only mechanism. Other investigators have shown that interferon can also do this, and that, like the antibodies, interferon acts through microglial activation. We think that this microglial activation is going to be a general paradigm in cognitive impairment in lupus and in other diseases, so microglia are a very good therapeutic target,” Dr. Diamond said.

The primary outcomes in the forthcoming randomized trial involve PET neuronal imaging. They investigators are hoping to see reduced hippocampal hypermetabolism and suppression of activated microglial cells.

“We’ll see if we’re actually hitting our target. We’re doing neuropsychologic testing, too, but we’re really concentrating on imaging outcomes, because those are objective and have many fewer variables to confound them,” according to Dr. Diamond.

Microglial activation is a current topic of intense research interest within the pharmaceutical industry, she added. If the imaging study is positive, she anticipates drug companies will quickly ramp up and conduct large clinical trials powered to show significant results in terms of neuropsychologic test scores and clinical outcomes.

Dr. Diamond reported having no financial conflicts regarding her work, which has been supported largely by the National Institutes of Health.

[email protected]

SAN FRANCISCO – The announcement of a first-ever multicenter randomized trial of ACE inhibitors for the treatment of cognitive impairment in systemic lupus erythematosus patients generated some of the biggest buzz at LUPUS 2019.

Bruce Jancin/MDedge News

“The time has come to implement clinical trials in lupus to see if we can address what is one of the most distressing aspects of the disease to patients,” Betty Diamond, MD, said in announcing the planned trial at an international congress on systemic lupus erythematosus (SLE).

Neuropsychiatric lupus, characterized most often by cognitive impairment, affects 40%-90% of SLE patients, according to various epidemiologic studies. This confusion and memory loss has been shown to be independent of systemic disease activity.

“Cognitive impairment is a very common problem and a very insidious problem in lupus patients,” emphasized Dr. Diamond, professor and head of the Center for Autoimmune Musculoskeletal and Hematopoietic Diseases at the Feinstein Institute for Medical Research in Manhasset, New York.

Dr. Diamond was the recipient of the 2018 Lupus Insight Prize awarded by the Lupus Research Alliance, which is funding the multicenter randomized trial. For the study, roughly 70 SLE patients with cognitive impairment not associated with a focal brain lesion will be randomized to receive a centrally acting ACE inhibitor – captopril was the one she and her coinvestigators have used in their mouse model and preliminary clinical studies – or to a non–centrally acting ACE inhibitor, such as enalapril.

“The clinical trial compares an ACE inhibitor that crosses the blood-brain barrier with one that doesn’t. They both have the same renal protection and systemic anti-inflammatory effects,” explained Dr. Diamond, who is also professor of molecular medicine and of medicine at the Zucker School of Medicine at Hofstra/Northwell, East Garden City, N.Y.

In a recent publication (J Exp Med. 2018 Oct 1;215[10]:2554-66), Dr. Diamond and her coinvestigators presented much of the background work that underpins the upcoming randomized trial. Sixteen years ago, they discovered two anti-DNA antibodies that cross-react with the N-methyl-D-aspartate receptor (NMDAR) and enhance NMDAR signaling. They showed that while the NMDARs are critical in learning and memory, their prolonged stimulation results in a high degree of calcium influx, causing neuronal death. These anti-DNA/anti-NMDAR antibodies, known as DNRAbs, are present at elevated titers in 30%-40% of SLE patients, and in a higher proportion of those with neuropsychiatric lupus.

“Most importantly, DNRAbs are present in the cerebrospinal fluid of patients who have nonfocal CNS manifestations of lupus,” Dr. Diamond said.

She and her coworkers developed a mouse model of cognitive impairment in lupus and utilized it to identify a two-stage model of the pathogenesis of DNRAb-mediated neuropsychiatric lupus. First, a traumatic event such as an infection causes a temporary opening in the blood-brain barrier, allowing the DNRAbs to reach the brain. This results in acute excitotoxic neuronal death. This is followed by a second stage, which entails activation of microglia – known as the macrophages of the CNS – with resultant loss of neuronal dendritic arborization and complexity. In the mouse model, this causes a selective impairment in spatial memory that corresponds well to the spatial memory deficit the investigators documented in DNRAb-positive SLE patients, compared with healthy controls and DNRAb-negative lupus patients.

A key finding in this project, Dr. Diamond continued, was that activated microglia turn out to be critical for dendritic loss. If the microglia are deactivated, regrowth of the dendritic processes occurs. This raises a possibility that attendees at LUPUS 2019 found thrilling: Perhaps the cognitive impairment of neuropsychiatric SLE can be prevented and even reversed by suppressing microglial activation.

Promising work in the field of Alzheimer’s disease suggests that centrally acting ACE inhibitors can indeed suppress microglial activation and actually improve cognition. Dr. Diamond and her colleagues showed this also was the case in their mouse model. Moreover, in a small clinical study they used PET brain imaging to show that captopril reduced the increased glucose uptake and hippocampal hypermetabolism associated with DNRAb-positive neuropsychiatric lupus, an effect maintained through 18 months of follow-up.

“We think DNRAbs contribute to cognitive impairment in SLE patients, but we certainly wouldn’t say that antibodies are the only mechanism. Other investigators have shown that interferon can also do this, and that, like the antibodies, interferon acts through microglial activation. We think that this microglial activation is going to be a general paradigm in cognitive impairment in lupus and in other diseases, so microglia are a very good therapeutic target,” Dr. Diamond said.

The primary outcomes in the forthcoming randomized trial involve PET neuronal imaging. They investigators are hoping to see reduced hippocampal hypermetabolism and suppression of activated microglial cells.

“We’ll see if we’re actually hitting our target. We’re doing neuropsychologic testing, too, but we’re really concentrating on imaging outcomes, because those are objective and have many fewer variables to confound them,” according to Dr. Diamond.

Microglial activation is a current topic of intense research interest within the pharmaceutical industry, she added. If the imaging study is positive, she anticipates drug companies will quickly ramp up and conduct large clinical trials powered to show significant results in terms of neuropsychologic test scores and clinical outcomes.

Dr. Diamond reported having no financial conflicts regarding her work, which has been supported largely by the National Institutes of Health.

[email protected]

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

SAN FRANCISCO – A telemedicine platform that connects patients to registered dietitians is providing a solution for a number of interrelated unmet needs, according to a description at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Although not limited to patients with gastrointestinal diseases, the applications of this platform are illustrative of the value to both patients and the physicians who prescribe diet as part of the management of chronic conditions, according to Jonah Cohen, MD, who is a founder of the digital therapeutics company Nutrimedy, which created the platform for virtual nutritional counseling.

“As gastroenterologists, we are experts in the function of the gastrointestinal tract but not necessarily in nutrition. Most physicians get very little training in this area,” said Dr. Cohen, who is a gastroenterologist affiliated with Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.

Even for those physicians who have expertise and an interest in nutrition, dietary counseling requires a substantial investment of time and continuity to affect behavior change. Helping patients develop an effective diet and implementation strategy to which they are willing to adhere is not a simple task. It requires recognizing and managing nuanced preferences and tastes. For most patients, frequent engagement with an expert is essential to remain on track.

“Nutrimedy’s proprietary matching system connects patients to their ideal dietitian who will help establish a specific nutrition plan for their medical conditions through video visits, unlimited messaging, photo food logs, recipes, and biometric trackers,” Dr. Cohen explained. “The key to the success of these relationships is based on the ease of clinical touch points we’re able to achieve through telenutrition when patients can ask questions, make modifications, and get positive feedback on their own time.”

Launched in 2016, Nutrimedy now has over 1,000 dietitians on its roster and a HIPAA-compliant device-agnostic platform to deliver best-in-class nutritional care remotely.

“The breadth of expertise of our providers enables us to provide medical nutrition therapy across a range of conditions, including irritable bowel syndrome (IBS), celiac disease, acid reflux, fatty liver disease, and gastroparesis to name just several, for patients anytime, anywhere,” according to Dr. Cohen.

In many places within the United States, there are few expert nutritionists with the specific expertise needed to manage a disease condition like IBS through low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, and thus appointments are often hard to get for these providers, according to Dr. Cohen. Moreover, he explained that office visits are not just inconvenient but can be an obstacle to a successfully implemented dietary plan.

Other challenges may include cultural or language barriers. Dr. Cohen gave the example of Sophia, a busy mother of two with IBS, who is vegetarian, eats predominantly Spanish cuisine, lives in rural Massachusetts, and speaks Spanish. She prefers not to take medications and hopes to better manage her condition with a low FODMAP diet.

Nutrimedy draws on its roster of registered dietitians to find a good match for patients like Sophia. “Our vision is that everyone deserves to have an expert literally in their back pocket to help them on their journey to better health through food as medicine,” Dr. Cohen explained. He called Nutrimedy “a turn-key solution for GI practices who want to improve medical nutrition therapy for their patients.”

According to Dr. Cohen, Nutrimedy has already proven effective for its core mission of making effective nutritional counseling easier to obtain, and is now working to extend its reach. For example, Dr. Cohen said that the company has actively engaged with employers to provide corporate wellness solutions, and it is partnering with pharmaceutical and other life sciences companies who offer therapies relevant to nutritional health where Nutrimedy has potential to serve as a digital therapeutic companion.

“In almost every chronic condition, diet plays an important role in disease prevention or management,” said Dr. Cohen who believes his company is participating in the effort to reduce the burden of chronic disease related to poor diet. “I feel that in 2019 we’re at a tipping point where health care entities are finally recognizing that we can transform wellness in America through healthier eating.” He believes that Nutrimedy is poised “to play a part in this revolution.

SAN FRANCISCO – A telemedicine platform that connects patients to registered dietitians is providing a solution for a number of interrelated unmet needs, according to a description at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Although not limited to patients with gastrointestinal diseases, the applications of this platform are illustrative of the value to both patients and the physicians who prescribe diet as part of the management of chronic conditions, according to Jonah Cohen, MD, who is a founder of the digital therapeutics company Nutrimedy, which created the platform for virtual nutritional counseling.

“As gastroenterologists, we are experts in the function of the gastrointestinal tract but not necessarily in nutrition. Most physicians get very little training in this area,” said Dr. Cohen, who is a gastroenterologist affiliated with Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.

Even for those physicians who have expertise and an interest in nutrition, dietary counseling requires a substantial investment of time and continuity to affect behavior change. Helping patients develop an effective diet and implementation strategy to which they are willing to adhere is not a simple task. It requires recognizing and managing nuanced preferences and tastes. For most patients, frequent engagement with an expert is essential to remain on track.

“Nutrimedy’s proprietary matching system connects patients to their ideal dietitian who will help establish a specific nutrition plan for their medical conditions through video visits, unlimited messaging, photo food logs, recipes, and biometric trackers,” Dr. Cohen explained. “The key to the success of these relationships is based on the ease of clinical touch points we’re able to achieve through telenutrition when patients can ask questions, make modifications, and get positive feedback on their own time.”

Launched in 2016, Nutrimedy now has over 1,000 dietitians on its roster and a HIPAA-compliant device-agnostic platform to deliver best-in-class nutritional care remotely.

“The breadth of expertise of our providers enables us to provide medical nutrition therapy across a range of conditions, including irritable bowel syndrome (IBS), celiac disease, acid reflux, fatty liver disease, and gastroparesis to name just several, for patients anytime, anywhere,” according to Dr. Cohen.

In many places within the United States, there are few expert nutritionists with the specific expertise needed to manage a disease condition like IBS through low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, and thus appointments are often hard to get for these providers, according to Dr. Cohen. Moreover, he explained that office visits are not just inconvenient but can be an obstacle to a successfully implemented dietary plan.

Other challenges may include cultural or language barriers. Dr. Cohen gave the example of Sophia, a busy mother of two with IBS, who is vegetarian, eats predominantly Spanish cuisine, lives in rural Massachusetts, and speaks Spanish. She prefers not to take medications and hopes to better manage her condition with a low FODMAP diet.

Nutrimedy draws on its roster of registered dietitians to find a good match for patients like Sophia. “Our vision is that everyone deserves to have an expert literally in their back pocket to help them on their journey to better health through food as medicine,” Dr. Cohen explained. He called Nutrimedy “a turn-key solution for GI practices who want to improve medical nutrition therapy for their patients.”

According to Dr. Cohen, Nutrimedy has already proven effective for its core mission of making effective nutritional counseling easier to obtain, and is now working to extend its reach. For example, Dr. Cohen said that the company has actively engaged with employers to provide corporate wellness solutions, and it is partnering with pharmaceutical and other life sciences companies who offer therapies relevant to nutritional health where Nutrimedy has potential to serve as a digital therapeutic companion.

“In almost every chronic condition, diet plays an important role in disease prevention or management,” said Dr. Cohen who believes his company is participating in the effort to reduce the burden of chronic disease related to poor diet. “I feel that in 2019 we’re at a tipping point where health care entities are finally recognizing that we can transform wellness in America through healthier eating.” He believes that Nutrimedy is poised “to play a part in this revolution.

SAN FRANCISCO – A telemedicine platform that connects patients to registered dietitians is providing a solution for a number of interrelated unmet needs, according to a description at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Although not limited to patients with gastrointestinal diseases, the applications of this platform are illustrative of the value to both patients and the physicians who prescribe diet as part of the management of chronic conditions, according to Jonah Cohen, MD, who is a founder of the digital therapeutics company Nutrimedy, which created the platform for virtual nutritional counseling.

“As gastroenterologists, we are experts in the function of the gastrointestinal tract but not necessarily in nutrition. Most physicians get very little training in this area,” said Dr. Cohen, who is a gastroenterologist affiliated with Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.

Even for those physicians who have expertise and an interest in nutrition, dietary counseling requires a substantial investment of time and continuity to affect behavior change. Helping patients develop an effective diet and implementation strategy to which they are willing to adhere is not a simple task. It requires recognizing and managing nuanced preferences and tastes. For most patients, frequent engagement with an expert is essential to remain on track.

“Nutrimedy’s proprietary matching system connects patients to their ideal dietitian who will help establish a specific nutrition plan for their medical conditions through video visits, unlimited messaging, photo food logs, recipes, and biometric trackers,” Dr. Cohen explained. “The key to the success of these relationships is based on the ease of clinical touch points we’re able to achieve through telenutrition when patients can ask questions, make modifications, and get positive feedback on their own time.”

Launched in 2016, Nutrimedy now has over 1,000 dietitians on its roster and a HIPAA-compliant device-agnostic platform to deliver best-in-class nutritional care remotely.

“The breadth of expertise of our providers enables us to provide medical nutrition therapy across a range of conditions, including irritable bowel syndrome (IBS), celiac disease, acid reflux, fatty liver disease, and gastroparesis to name just several, for patients anytime, anywhere,” according to Dr. Cohen.

In many places within the United States, there are few expert nutritionists with the specific expertise needed to manage a disease condition like IBS through low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, and thus appointments are often hard to get for these providers, according to Dr. Cohen. Moreover, he explained that office visits are not just inconvenient but can be an obstacle to a successfully implemented dietary plan.

Other challenges may include cultural or language barriers. Dr. Cohen gave the example of Sophia, a busy mother of two with IBS, who is vegetarian, eats predominantly Spanish cuisine, lives in rural Massachusetts, and speaks Spanish. She prefers not to take medications and hopes to better manage her condition with a low FODMAP diet.

Nutrimedy draws on its roster of registered dietitians to find a good match for patients like Sophia. “Our vision is that everyone deserves to have an expert literally in their back pocket to help them on their journey to better health through food as medicine,” Dr. Cohen explained. He called Nutrimedy “a turn-key solution for GI practices who want to improve medical nutrition therapy for their patients.”

According to Dr. Cohen, Nutrimedy has already proven effective for its core mission of making effective nutritional counseling easier to obtain, and is now working to extend its reach. For example, Dr. Cohen said that the company has actively engaged with employers to provide corporate wellness solutions, and it is partnering with pharmaceutical and other life sciences companies who offer therapies relevant to nutritional health where Nutrimedy has potential to serve as a digital therapeutic companion.

“In almost every chronic condition, diet plays an important role in disease prevention or management,” said Dr. Cohen who believes his company is participating in the effort to reduce the burden of chronic disease related to poor diet. “I feel that in 2019 we’re at a tipping point where health care entities are finally recognizing that we can transform wellness in America through healthier eating.” He believes that Nutrimedy is poised “to play a part in this revolution.

SAN FRANCISCO – Patients are being better prepared for medical procedures, such as screening colonoscopy, through a new service based on smartphone texts that remind patients of steps to take prior to their procedure, according to a description at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“The reminders mean fewer no shows and fewer cancellations, but in the case of colonoscopy we are also seeing better rates of adequate bowel prep and lower rates of aborted procedures,” reported Andy Pfau, chief operating officer, RxHealth, New York.

The texts are based on a patient-care pathway integrated with the electronic medical record (EMR) system. In the case of colonoscopy, once a physician creates an appointment in the EMR for a colonoscopy and selects the bowel prep, the system takes over, automatically obtaining access to the patient’s cell phone number in order to send reminder texts at intervals relevant to their appointment.

“The texts provide links to additional information so that patients are not only reminded to begin their bowel prep but can access instructions and supportive educational material,” Mr. Pfau explained.

“The messaging is not just limited to reminders. We can provide driving and parking instructions. We have also partnered with ride sharing companies to make it easier for patients to get to the facility. We can adjust the platform in a variety of ways to help patients show up prepared for the procedure,” he added.

The commercial tool, known as RxUniverse, was a spin off of a program developed at the Icahn School of Medicine at Mount Sinai. The problem of no shows and the importance of bowel prep makes this service particularly attractive in colonoscopy, according to Mr. Pfau, who cited data associating this tool with a 34% improvement in bowel preps and a more than 90% rate of patient satisfaction.

The same approach can and already is being employed in other procedures in GI, such as guiding patients scheduled for an upper endoscopy.

“We see a large role for this tool in comprehensive care plans because it is versatile and could be applied to a variety of care pathways, including forms of telemedicine, where timely communication through smartphone messaging could help patients adhere to goals of treatment,” Mr. Pfau said.

The tool can already be integrated with four EMR systems, including EPIC, but Mr. Pfau said the tool will ultimately be EMR agonistic according to current plans. While the company spun out of Mount Sinai in late 2016, RxHealth began marketing the RxUniverse prescription platform in earnest in 2018.

“In the last eight or so months, growth has been exponential,” Mr. Pfau said. In addition to growth in the U.S., the program is now being marketed overseas. He named several large medical systems that have already adopted the technology, including the Arizona Centers for Digestive Health and Yale New Haven Health. The American Gastroenterological Association, recognizing the value of this innovation for GI, has also partnered with RxHealth to help bring this product to its members.

As the automated pathway is integrated into existing EMR systems, the per-patient cost of the pathway is relatively low, according to Mr. Pfau. In situations in which the service increases the proportion of procedures completed successfully, it is reasonable to expect a highly favorable return on investment.

“There is a lot of interest in the potential of mobile devices to be employed in various ways to communicate and inform patients. This is part of that, and we think it is just the beginning. We are looking at a number of ways in which we can expand the platform and make it even more valuable,” Mr. Pfau said.

SAN FRANCISCO – Patients are being better prepared for medical procedures, such as screening colonoscopy, through a new service based on smartphone texts that remind patients of steps to take prior to their procedure, according to a description at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“The reminders mean fewer no shows and fewer cancellations, but in the case of colonoscopy we are also seeing better rates of adequate bowel prep and lower rates of aborted procedures,” reported Andy Pfau, chief operating officer, RxHealth, New York.

The texts are based on a patient-care pathway integrated with the electronic medical record (EMR) system. In the case of colonoscopy, once a physician creates an appointment in the EMR for a colonoscopy and selects the bowel prep, the system takes over, automatically obtaining access to the patient’s cell phone number in order to send reminder texts at intervals relevant to their appointment.

“The texts provide links to additional information so that patients are not only reminded to begin their bowel prep but can access instructions and supportive educational material,” Mr. Pfau explained.

“The messaging is not just limited to reminders. We can provide driving and parking instructions. We have also partnered with ride sharing companies to make it easier for patients to get to the facility. We can adjust the platform in a variety of ways to help patients show up prepared for the procedure,” he added.

The commercial tool, known as RxUniverse, was a spin off of a program developed at the Icahn School of Medicine at Mount Sinai. The problem of no shows and the importance of bowel prep makes this service particularly attractive in colonoscopy, according to Mr. Pfau, who cited data associating this tool with a 34% improvement in bowel preps and a more than 90% rate of patient satisfaction.

The same approach can and already is being employed in other procedures in GI, such as guiding patients scheduled for an upper endoscopy.

“We see a large role for this tool in comprehensive care plans because it is versatile and could be applied to a variety of care pathways, including forms of telemedicine, where timely communication through smartphone messaging could help patients adhere to goals of treatment,” Mr. Pfau said.

The tool can already be integrated with four EMR systems, including EPIC, but Mr. Pfau said the tool will ultimately be EMR agonistic according to current plans. While the company spun out of Mount Sinai in late 2016, RxHealth began marketing the RxUniverse prescription platform in earnest in 2018.

“In the last eight or so months, growth has been exponential,” Mr. Pfau said. In addition to growth in the U.S., the program is now being marketed overseas. He named several large medical systems that have already adopted the technology, including the Arizona Centers for Digestive Health and Yale New Haven Health. The American Gastroenterological Association, recognizing the value of this innovation for GI, has also partnered with RxHealth to help bring this product to its members.

As the automated pathway is integrated into existing EMR systems, the per-patient cost of the pathway is relatively low, according to Mr. Pfau. In situations in which the service increases the proportion of procedures completed successfully, it is reasonable to expect a highly favorable return on investment.

“There is a lot of interest in the potential of mobile devices to be employed in various ways to communicate and inform patients. This is part of that, and we think it is just the beginning. We are looking at a number of ways in which we can expand the platform and make it even more valuable,” Mr. Pfau said.

SAN FRANCISCO – Patients are being better prepared for medical procedures, such as screening colonoscopy, through a new service based on smartphone texts that remind patients of steps to take prior to their procedure, according to a description at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“The reminders mean fewer no shows and fewer cancellations, but in the case of colonoscopy we are also seeing better rates of adequate bowel prep and lower rates of aborted procedures,” reported Andy Pfau, chief operating officer, RxHealth, New York.

The texts are based on a patient-care pathway integrated with the electronic medical record (EMR) system. In the case of colonoscopy, once a physician creates an appointment in the EMR for a colonoscopy and selects the bowel prep, the system takes over, automatically obtaining access to the patient’s cell phone number in order to send reminder texts at intervals relevant to their appointment.

“The texts provide links to additional information so that patients are not only reminded to begin their bowel prep but can access instructions and supportive educational material,” Mr. Pfau explained.

“The messaging is not just limited to reminders. We can provide driving and parking instructions. We have also partnered with ride sharing companies to make it easier for patients to get to the facility. We can adjust the platform in a variety of ways to help patients show up prepared for the procedure,” he added.

The commercial tool, known as RxUniverse, was a spin off of a program developed at the Icahn School of Medicine at Mount Sinai. The problem of no shows and the importance of bowel prep makes this service particularly attractive in colonoscopy, according to Mr. Pfau, who cited data associating this tool with a 34% improvement in bowel preps and a more than 90% rate of patient satisfaction.

The same approach can and already is being employed in other procedures in GI, such as guiding patients scheduled for an upper endoscopy.

“We see a large role for this tool in comprehensive care plans because it is versatile and could be applied to a variety of care pathways, including forms of telemedicine, where timely communication through smartphone messaging could help patients adhere to goals of treatment,” Mr. Pfau said.

The tool can already be integrated with four EMR systems, including EPIC, but Mr. Pfau said the tool will ultimately be EMR agonistic according to current plans. While the company spun out of Mount Sinai in late 2016, RxHealth began marketing the RxUniverse prescription platform in earnest in 2018.

“In the last eight or so months, growth has been exponential,” Mr. Pfau said. In addition to growth in the U.S., the program is now being marketed overseas. He named several large medical systems that have already adopted the technology, including the Arizona Centers for Digestive Health and Yale New Haven Health. The American Gastroenterological Association, recognizing the value of this innovation for GI, has also partnered with RxHealth to help bring this product to its members.

As the automated pathway is integrated into existing EMR systems, the per-patient cost of the pathway is relatively low, according to Mr. Pfau. In situations in which the service increases the proportion of procedures completed successfully, it is reasonable to expect a highly favorable return on investment.

“There is a lot of interest in the potential of mobile devices to be employed in various ways to communicate and inform patients. This is part of that, and we think it is just the beginning. We are looking at a number of ways in which we can expand the platform and make it even more valuable,” Mr. Pfau said.

SAN FRANCISCO – The seasonality of lupus flares is likely the result of variations in atmospheric and climatic conditions, according to investigators from Johns Hopkins University, Baltimore.

The work helps solve a longstanding mystery in systemic lupus erythematosus (SLE): why symptoms seem to come and go with the seasons.
 

Johns Hopkins University research previously has shown that renal flares are more common in the winter; double-stranded DNA antibodies more common in late fall; and rashes more likely in late spring.

However, “the exact reasons of why the seasonality was there remained a big question,” said lead investigator George Stojan, MD, an assistant professor of rheumatology and the codirector of the Hopkins Lupus Center.

To get a handle on the matter, Dr. Stojan and his team reviewed 1,628 patients treated at the university during 1999-2017. Using Environmental Protection Agency data, they examined atmospheric conditions within 350 km of Baltimore in the 10 days leading up to lupus visits for flares; the researchers adjusted for age, sex, income, ethnicity, rural versus urban residence, and how close patients lived to highways and airports.

“We [found] specific, strong associations between atmospheric variables and fine particulate matter concentrations ... and organ-specific lupus flares,” Dr. Stojan said. He explained why that matters in a video interview at an international congress on SLE.

In short, rash was directly associated with concentrations of ozone and inhalable, fine particulate matter less than 2.5 mcm in diameter (PM 2.5). Joint flares were associated with PM 2.5, ozone, resultant wind, and humidity.

Renal flares were inversely associated with temperature, and directly associated with wind and humidity. Pulmonary flares and serositis were associated with PM 2.5, and both hematologic and neurologic flares with wind and temperature.

The analysis was based on a per-unit basis. For example, each mcg/m³ increase in PM 2.5 increased the odds of a pulmonary flare about 4% (odds ratio, 1.042, P = .026). The other findings were mostly of smaller magnitude, but still statistically significant.

The National Institutes of Health funded the research. Dr. Stojan had no disclosures.

[email protected]

SOURCE: Stojan G et al. LUPUS 2019, Abstract M31.

SAN FRANCISCO – The seasonality of lupus flares is likely the result of variations in atmospheric and climatic conditions, according to investigators from Johns Hopkins University, Baltimore.

The work helps solve a longstanding mystery in systemic lupus erythematosus (SLE): why symptoms seem to come and go with the seasons.
 

Johns Hopkins University research previously has shown that renal flares are more common in the winter; double-stranded DNA antibodies more common in late fall; and rashes more likely in late spring.

However, “the exact reasons of why the seasonality was there remained a big question,” said lead investigator George Stojan, MD, an assistant professor of rheumatology and the codirector of the Hopkins Lupus Center.

To get a handle on the matter, Dr. Stojan and his team reviewed 1,628 patients treated at the university during 1999-2017. Using Environmental Protection Agency data, they examined atmospheric conditions within 350 km of Baltimore in the 10 days leading up to lupus visits for flares; the researchers adjusted for age, sex, income, ethnicity, rural versus urban residence, and how close patients lived to highways and airports.

“We [found] specific, strong associations between atmospheric variables and fine particulate matter concentrations ... and organ-specific lupus flares,” Dr. Stojan said. He explained why that matters in a video interview at an international congress on SLE.

In short, rash was directly associated with concentrations of ozone and inhalable, fine particulate matter less than 2.5 mcm in diameter (PM 2.5). Joint flares were associated with PM 2.5, ozone, resultant wind, and humidity.

Renal flares were inversely associated with temperature, and directly associated with wind and humidity. Pulmonary flares and serositis were associated with PM 2.5, and both hematologic and neurologic flares with wind and temperature.

The analysis was based on a per-unit basis. For example, each mcg/m³ increase in PM 2.5 increased the odds of a pulmonary flare about 4% (odds ratio, 1.042, P = .026). The other findings were mostly of smaller magnitude, but still statistically significant.

The National Institutes of Health funded the research. Dr. Stojan had no disclosures.

[email protected]

SOURCE: Stojan G et al. LUPUS 2019, Abstract M31.

SAN FRANCISCO – The seasonality of lupus flares is likely the result of variations in atmospheric and climatic conditions, according to investigators from Johns Hopkins University, Baltimore.

The work helps solve a longstanding mystery in systemic lupus erythematosus (SLE): why symptoms seem to come and go with the seasons.
 

Johns Hopkins University research previously has shown that renal flares are more common in the winter; double-stranded DNA antibodies more common in late fall; and rashes more likely in late spring.

However, “the exact reasons of why the seasonality was there remained a big question,” said lead investigator George Stojan, MD, an assistant professor of rheumatology and the codirector of the Hopkins Lupus Center.

To get a handle on the matter, Dr. Stojan and his team reviewed 1,628 patients treated at the university during 1999-2017. Using Environmental Protection Agency data, they examined atmospheric conditions within 350 km of Baltimore in the 10 days leading up to lupus visits for flares; the researchers adjusted for age, sex, income, ethnicity, rural versus urban residence, and how close patients lived to highways and airports.

“We [found] specific, strong associations between atmospheric variables and fine particulate matter concentrations ... and organ-specific lupus flares,” Dr. Stojan said. He explained why that matters in a video interview at an international congress on SLE.

In short, rash was directly associated with concentrations of ozone and inhalable, fine particulate matter less than 2.5 mcm in diameter (PM 2.5). Joint flares were associated with PM 2.5, ozone, resultant wind, and humidity.

Renal flares were inversely associated with temperature, and directly associated with wind and humidity. Pulmonary flares and serositis were associated with PM 2.5, and both hematologic and neurologic flares with wind and temperature.

The analysis was based on a per-unit basis. For example, each mcg/m³ increase in PM 2.5 increased the odds of a pulmonary flare about 4% (odds ratio, 1.042, P = .026). The other findings were mostly of smaller magnitude, but still statistically significant.

The National Institutes of Health funded the research. Dr. Stojan had no disclosures.

[email protected]

SOURCE: Stojan G et al. LUPUS 2019, Abstract M31.

It happens to all of us: You log onto the Internet one day and discover a scathing review from a disgruntled patient or family member, usually complaining about something totally irrelevant to the excellent care they received.

Urupong/Getty Images

Your first impulse may be to post a response, but wait – it turns out that “protected health information” is more liberally defined than most of us think. If you include any information that could be used to identify the patient, you can be considered in violation of HIPAA. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights; and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

In 2013, a California hospital paid $275,000 to settle claims that it violated HIPAA when it disclosed a patient’s health information in response to a negative review. And the Department of Health & Human Services, which enforces HIPAA, has sent warning letters to a variety of physicians and dentists who divulged patient information while responding to reviews. (An HHS spokesperson couldn’t tell me how many such warnings have been issued, because they “don’t track complaints that way.”)

All of that said, there are legal and ethical ways to deal with negative reviews. Here are three such options:

• Ignore them. This is your best choice 90% of the time. Most negative reviews have minimal impact and simply do not deserve a response, and responding may simply pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site, and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated. If your total number of reviews on that site is too small – for example, there are only 4, and 2 are bad – you have what I call a denominator problem. The solution in those cases is to increase the denominator – that is, increase the total number of reviews. The more you can obtain, the less impact the complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, in your e-mail reminders, or simply leave a stack of requests at your check-out desk and tell your receptionist to hand them out. To be clear, you must encourage all reviews, good or bad, not just favorable ones; if you specify that all reviews must be favorable, you are “filtering,” which can be perceived as false or deceptive advertising.
• Respond generically. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies, or direct readers to positive reviews without referencing any individual cases. You might point out that HIPAA prevents you from disclosing information in response. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. In select situations, this has been very effective for me; in one case, the patient not only removed the negative post, but also became a loyal supporter. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can at least explain that on the site, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely, and I will address that in next month’s column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It happens to all of us: You log onto the Internet one day and discover a scathing review from a disgruntled patient or family member, usually complaining about something totally irrelevant to the excellent care they received.

Urupong/Getty Images

Your first impulse may be to post a response, but wait – it turns out that “protected health information” is more liberally defined than most of us think. If you include any information that could be used to identify the patient, you can be considered in violation of HIPAA. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights; and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

In 2013, a California hospital paid $275,000 to settle claims that it violated HIPAA when it disclosed a patient’s health information in response to a negative review. And the Department of Health & Human Services, which enforces HIPAA, has sent warning letters to a variety of physicians and dentists who divulged patient information while responding to reviews. (An HHS spokesperson couldn’t tell me how many such warnings have been issued, because they “don’t track complaints that way.”)

All of that said, there are legal and ethical ways to deal with negative reviews. Here are three such options:

• Ignore them. This is your best choice 90% of the time. Most negative reviews have minimal impact and simply do not deserve a response, and responding may simply pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site, and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated. If your total number of reviews on that site is too small – for example, there are only 4, and 2 are bad – you have what I call a denominator problem. The solution in those cases is to increase the denominator – that is, increase the total number of reviews. The more you can obtain, the less impact the complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, in your e-mail reminders, or simply leave a stack of requests at your check-out desk and tell your receptionist to hand them out. To be clear, you must encourage all reviews, good or bad, not just favorable ones; if you specify that all reviews must be favorable, you are “filtering,” which can be perceived as false or deceptive advertising.
• Respond generically. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies, or direct readers to positive reviews without referencing any individual cases. You might point out that HIPAA prevents you from disclosing information in response. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. In select situations, this has been very effective for me; in one case, the patient not only removed the negative post, but also became a loyal supporter. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can at least explain that on the site, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely, and I will address that in next month’s column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It happens to all of us: You log onto the Internet one day and discover a scathing review from a disgruntled patient or family member, usually complaining about something totally irrelevant to the excellent care they received.

Urupong/Getty Images

Your first impulse may be to post a response, but wait – it turns out that “protected health information” is more liberally defined than most of us think. If you include any information that could be used to identify the patient, you can be considered in violation of HIPAA. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights; and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

In 2013, a California hospital paid $275,000 to settle claims that it violated HIPAA when it disclosed a patient’s health information in response to a negative review. And the Department of Health & Human Services, which enforces HIPAA, has sent warning letters to a variety of physicians and dentists who divulged patient information while responding to reviews. (An HHS spokesperson couldn’t tell me how many such warnings have been issued, because they “don’t track complaints that way.”)

All of that said, there are legal and ethical ways to deal with negative reviews. Here are three such options:

• Ignore them. This is your best choice 90% of the time. Most negative reviews have minimal impact and simply do not deserve a response, and responding may simply pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site, and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated. If your total number of reviews on that site is too small – for example, there are only 4, and 2 are bad – you have what I call a denominator problem. The solution in those cases is to increase the denominator – that is, increase the total number of reviews. The more you can obtain, the less impact the complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, in your e-mail reminders, or simply leave a stack of requests at your check-out desk and tell your receptionist to hand them out. To be clear, you must encourage all reviews, good or bad, not just favorable ones; if you specify that all reviews must be favorable, you are “filtering,” which can be perceived as false or deceptive advertising.
• Respond generically. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies, or direct readers to positive reviews without referencing any individual cases. You might point out that HIPAA prevents you from disclosing information in response. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. In select situations, this has been very effective for me; in one case, the patient not only removed the negative post, but also became a loyal supporter. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can at least explain that on the site, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely, and I will address that in next month’s column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].