Despite its widespread use as a guideline-recommended, first-line agent for the treatment of hypertension, hydrochlorothiazide (HCTZ) may contribute to an increased risk of skin cancer, according to Armand B. Cognetta Jr., MD, and his associates in the division of dermatology, Mohs Micrographic Surgery Unit, Florida State University, Tallahassee.

The common, long-term use of HCTZ for treatment of hypertension, combined with its known photosensitizing effects, makes it a potential candidate for increasing the risk of squamous cell carcinoma (SCC) and other skin cancers.

To further elucidate the association between longterm HCTZ exposure and skin cancer risk, Dr. Cognetta and his associates screened medication lists of 75 patients seen in their Mohs practice over a period of 5 days for lifetime SCCs and HCTZ exposure. For this study, patients with more than 20 lifetime SCCs were considered high risk. They also conducted a literature review of previous studies exploring this relationship, from 1966 to 2015.

Of the 75 patients screened, 4 met the criteria for inclusion in the high risk category. These four patients had a combined lifetime total of 288 SCC and 98 basal cell carcinomas (BCCs), including 10 that were lip SCC. All four patients were non-Hispanic white males and had been taking HCTZ alone or in combination for 3-15 years (Dermatol Surg. 2016 Sep;42[9]:1107-9).

The literature search produced three relevant studies, all of which had large patient populations, published between 2008 and 2012, “demonstrating an increased risk of SCC or lip cancer” associated with HCTZ use, with the highest risk associated with over 5 years of use, the researchers wrote.

“As cutaneous oncologists, it is our duty to look for ‘correctable’ causes of skin cancer,” they noted. “Hydrochlorothiazide, a known photosensitizer, when taken by white non-Hispanic patients with a history of multiple SCC, skin cancers may represent a ‘correctable’ cause.”

In their practice, they screen their high-risk SCC non-Hispanic patients for HCTZ use, “and send a standard letter explaining the association to the primary care provider with a request to change to a different antihypertensive if possible,” they wrote. “Many primary care providers are unaware of the association between HCTZ use and skin cancer,” they observed.

The authors had no disclosures.

Despite its widespread use as a guideline-recommended, first-line agent for the treatment of hypertension, hydrochlorothiazide (HCTZ) may contribute to an increased risk of skin cancer, according to Armand B. Cognetta Jr., MD, and his associates in the division of dermatology, Mohs Micrographic Surgery Unit, Florida State University, Tallahassee.

The common, long-term use of HCTZ for treatment of hypertension, combined with its known photosensitizing effects, makes it a potential candidate for increasing the risk of squamous cell carcinoma (SCC) and other skin cancers.

To further elucidate the association between longterm HCTZ exposure and skin cancer risk, Dr. Cognetta and his associates screened medication lists of 75 patients seen in their Mohs practice over a period of 5 days for lifetime SCCs and HCTZ exposure. For this study, patients with more than 20 lifetime SCCs were considered high risk. They also conducted a literature review of previous studies exploring this relationship, from 1966 to 2015.

Of the 75 patients screened, 4 met the criteria for inclusion in the high risk category. These four patients had a combined lifetime total of 288 SCC and 98 basal cell carcinomas (BCCs), including 10 that were lip SCC. All four patients were non-Hispanic white males and had been taking HCTZ alone or in combination for 3-15 years (Dermatol Surg. 2016 Sep;42[9]:1107-9).

The literature search produced three relevant studies, all of which had large patient populations, published between 2008 and 2012, “demonstrating an increased risk of SCC or lip cancer” associated with HCTZ use, with the highest risk associated with over 5 years of use, the researchers wrote.

“As cutaneous oncologists, it is our duty to look for ‘correctable’ causes of skin cancer,” they noted. “Hydrochlorothiazide, a known photosensitizer, when taken by white non-Hispanic patients with a history of multiple SCC, skin cancers may represent a ‘correctable’ cause.”

In their practice, they screen their high-risk SCC non-Hispanic patients for HCTZ use, “and send a standard letter explaining the association to the primary care provider with a request to change to a different antihypertensive if possible,” they wrote. “Many primary care providers are unaware of the association between HCTZ use and skin cancer,” they observed.

The authors had no disclosures.

Despite its widespread use as a guideline-recommended, first-line agent for the treatment of hypertension, hydrochlorothiazide (HCTZ) may contribute to an increased risk of skin cancer, according to Armand B. Cognetta Jr., MD, and his associates in the division of dermatology, Mohs Micrographic Surgery Unit, Florida State University, Tallahassee.

The common, long-term use of HCTZ for treatment of hypertension, combined with its known photosensitizing effects, makes it a potential candidate for increasing the risk of squamous cell carcinoma (SCC) and other skin cancers.

To further elucidate the association between longterm HCTZ exposure and skin cancer risk, Dr. Cognetta and his associates screened medication lists of 75 patients seen in their Mohs practice over a period of 5 days for lifetime SCCs and HCTZ exposure. For this study, patients with more than 20 lifetime SCCs were considered high risk. They also conducted a literature review of previous studies exploring this relationship, from 1966 to 2015.

Of the 75 patients screened, 4 met the criteria for inclusion in the high risk category. These four patients had a combined lifetime total of 288 SCC and 98 basal cell carcinomas (BCCs), including 10 that were lip SCC. All four patients were non-Hispanic white males and had been taking HCTZ alone or in combination for 3-15 years (Dermatol Surg. 2016 Sep;42[9]:1107-9).

The literature search produced three relevant studies, all of which had large patient populations, published between 2008 and 2012, “demonstrating an increased risk of SCC or lip cancer” associated with HCTZ use, with the highest risk associated with over 5 years of use, the researchers wrote.

“As cutaneous oncologists, it is our duty to look for ‘correctable’ causes of skin cancer,” they noted. “Hydrochlorothiazide, a known photosensitizer, when taken by white non-Hispanic patients with a history of multiple SCC, skin cancers may represent a ‘correctable’ cause.”

In their practice, they screen their high-risk SCC non-Hispanic patients for HCTZ use, “and send a standard letter explaining the association to the primary care provider with a request to change to a different antihypertensive if possible,” they wrote. “Many primary care providers are unaware of the association between HCTZ use and skin cancer,” they observed.

The authors had no disclosures.

Researcher examines

tumor in a test tube

Photo by Rhoda Baer

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.

The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.

The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

Both the HHS rule and the NIH policy will be effective on January 18, 2017.

“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.

“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”

About the HHS rule

The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.

Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.

Elements of the rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
• Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance.

About the NIH policy

The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).

The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.

Researcher examines

tumor in a test tube

Photo by Rhoda Baer

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.

The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.

The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

Both the HHS rule and the NIH policy will be effective on January 18, 2017.

“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.

“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”

About the HHS rule

The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.

Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.

Elements of the rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
• Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance.

About the NIH policy

The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).

The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.

Researcher examines

tumor in a test tube

Photo by Rhoda Baer

The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.

The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.

The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

Both the HHS rule and the NIH policy will be effective on January 18, 2017.

“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.

“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”

About the HHS rule

The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.

Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.

Elements of the rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
• Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance.

About the NIH policy

The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).

The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.

WAIKOLOA, HI. – If you openly share your institution’s use of damage control laparotomy, it is possible to safely decrease use of the procedure, according to results from a 2-year, single-center quality improvement project.

“Damage control laparotomy (DCL) is currently overused, both in trauma and general surgery,” John A. Harvin, MD, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “One of the barriers to discussing the overuse is that no one knows what the ‘right’ rate of DCL should be. The vast majority of papers reporting findings regarding DCL fail to provide a denominator, thus actual rates of DCL across the country are not known. It is only by word of mouth that the overuse comes out.”

In a quality improvement (QI) project designed to decrease the rate of DCL at the University of Texas Health Science Center, Houston, Dr. Harvin and his associates prospectively evaluated all emergent laparotomies performed at the institution from November 2013 to October 2015. During year 1 of the QI project, trauma faculty completed report cards immediately following every DCL. During year 2, the researchers collectively reviewed DCLs every other month to determine which patients may have safely undergone definitive laparotomy. They prospectively compared the morbidity and mortality of patients in the quality improvement group with that of a published historical cohort group of patients who underwent emergent laparotomy between January 2011 and October 2013 (Am. J. Surg. 2016;212[1]:34-9).

Dr. Harvin of the division of acute care surgery at the university, reported that the rate of DCL among the historical control group was 39%. Soon after the QI project was implemented the DCL rate fell to 23% (P less than .05), and it declined further following completion of the project, to 18%. “This was accomplished by open discussion among our faculty on who and why DCL was done,” he said. “Over the course of the 2-year QI project, approximately 70 DCLs were avoided without an increase in complications or mortality.”

Many of the findings surprised the researchers, including the fact that the indications for DCL did not differ before and after implementation of the QI project. “So, surgeons did not necessarily abandon certain indications but used all indications more selectively,” Dr. Harvin noted. “That being said, we were able to identify a few indications for DCL that may or may not be necessary. Lastly, despite a significant reduction in the overall use of DCL, we saw no change in rates of complications. This flies in the face of many papers reporting an association between DCL and all kinds of morbidities.”

He acknowledged certain limitations of the study, including the fact that the researchers identified a Hawthorne effect after implementation of the QI intervention. “Despite this, there was a sustained reduction in the rate of DCL that persisted following termination of the project,” Dr. Harvin said. “Additionally, this is not a randomized clinical trial, but a before and after trial which is subject to the usual methodological flaws such as confounding by temporal change and differences in baseline characteristics of the patient populations.” He reported having no financial disclosures.

[email protected]

WAIKOLOA, HI. – If you openly share your institution’s use of damage control laparotomy, it is possible to safely decrease use of the procedure, according to results from a 2-year, single-center quality improvement project.

“Damage control laparotomy (DCL) is currently overused, both in trauma and general surgery,” John A. Harvin, MD, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “One of the barriers to discussing the overuse is that no one knows what the ‘right’ rate of DCL should be. The vast majority of papers reporting findings regarding DCL fail to provide a denominator, thus actual rates of DCL across the country are not known. It is only by word of mouth that the overuse comes out.”

In a quality improvement (QI) project designed to decrease the rate of DCL at the University of Texas Health Science Center, Houston, Dr. Harvin and his associates prospectively evaluated all emergent laparotomies performed at the institution from November 2013 to October 2015. During year 1 of the QI project, trauma faculty completed report cards immediately following every DCL. During year 2, the researchers collectively reviewed DCLs every other month to determine which patients may have safely undergone definitive laparotomy. They prospectively compared the morbidity and mortality of patients in the quality improvement group with that of a published historical cohort group of patients who underwent emergent laparotomy between January 2011 and October 2013 (Am. J. Surg. 2016;212[1]:34-9).

Dr. Harvin of the division of acute care surgery at the university, reported that the rate of DCL among the historical control group was 39%. Soon after the QI project was implemented the DCL rate fell to 23% (P less than .05), and it declined further following completion of the project, to 18%. “This was accomplished by open discussion among our faculty on who and why DCL was done,” he said. “Over the course of the 2-year QI project, approximately 70 DCLs were avoided without an increase in complications or mortality.”

Many of the findings surprised the researchers, including the fact that the indications for DCL did not differ before and after implementation of the QI project. “So, surgeons did not necessarily abandon certain indications but used all indications more selectively,” Dr. Harvin noted. “That being said, we were able to identify a few indications for DCL that may or may not be necessary. Lastly, despite a significant reduction in the overall use of DCL, we saw no change in rates of complications. This flies in the face of many papers reporting an association between DCL and all kinds of morbidities.”

He acknowledged certain limitations of the study, including the fact that the researchers identified a Hawthorne effect after implementation of the QI intervention. “Despite this, there was a sustained reduction in the rate of DCL that persisted following termination of the project,” Dr. Harvin said. “Additionally, this is not a randomized clinical trial, but a before and after trial which is subject to the usual methodological flaws such as confounding by temporal change and differences in baseline characteristics of the patient populations.” He reported having no financial disclosures.

[email protected]

WAIKOLOA, HI. – If you openly share your institution’s use of damage control laparotomy, it is possible to safely decrease use of the procedure, according to results from a 2-year, single-center quality improvement project.

“Damage control laparotomy (DCL) is currently overused, both in trauma and general surgery,” John A. Harvin, MD, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “One of the barriers to discussing the overuse is that no one knows what the ‘right’ rate of DCL should be. The vast majority of papers reporting findings regarding DCL fail to provide a denominator, thus actual rates of DCL across the country are not known. It is only by word of mouth that the overuse comes out.”

In a quality improvement (QI) project designed to decrease the rate of DCL at the University of Texas Health Science Center, Houston, Dr. Harvin and his associates prospectively evaluated all emergent laparotomies performed at the institution from November 2013 to October 2015. During year 1 of the QI project, trauma faculty completed report cards immediately following every DCL. During year 2, the researchers collectively reviewed DCLs every other month to determine which patients may have safely undergone definitive laparotomy. They prospectively compared the morbidity and mortality of patients in the quality improvement group with that of a published historical cohort group of patients who underwent emergent laparotomy between January 2011 and October 2013 (Am. J. Surg. 2016;212[1]:34-9).

Dr. Harvin of the division of acute care surgery at the university, reported that the rate of DCL among the historical control group was 39%. Soon after the QI project was implemented the DCL rate fell to 23% (P less than .05), and it declined further following completion of the project, to 18%. “This was accomplished by open discussion among our faculty on who and why DCL was done,” he said. “Over the course of the 2-year QI project, approximately 70 DCLs were avoided without an increase in complications or mortality.”

Many of the findings surprised the researchers, including the fact that the indications for DCL did not differ before and after implementation of the QI project. “So, surgeons did not necessarily abandon certain indications but used all indications more selectively,” Dr. Harvin noted. “That being said, we were able to identify a few indications for DCL that may or may not be necessary. Lastly, despite a significant reduction in the overall use of DCL, we saw no change in rates of complications. This flies in the face of many papers reporting an association between DCL and all kinds of morbidities.”

He acknowledged certain limitations of the study, including the fact that the researchers identified a Hawthorne effect after implementation of the QI intervention. “Despite this, there was a sustained reduction in the rate of DCL that persisted following termination of the project,” Dr. Harvin said. “Additionally, this is not a randomized clinical trial, but a before and after trial which is subject to the usual methodological flaws such as confounding by temporal change and differences in baseline characteristics of the patient populations.” He reported having no financial disclosures.

[email protected]

MINNEAPOLIS – Missed diagnoses, lack of care coordination, and security concerns were among the gaps in care that appeared when research personnel with simulated skin problems used direct-to-consumer (DTC) sites for telemedicine consults in a recently published study that highlighted potential drawbacks of this technology.

While telemedicine “has potential to expand access, and the medical literature is filled with examples of telehealth systems providing quality care,” the authors of the study concluded, their results “raise doubts about the quality of skin disease diagnosis and treatment being provided by a variety of DTC telemedicine websites and apps” (JAMA Dermatol. 2016;152[7]:768-775).

Karen Edison, MD, a dermatologist and telemedicine pioneer, shared results of the study that addressed the quality of DTC teledermatology, a rapidly growing market, at the annual meeting of the Society for Pediatric Dermatology. The DTC telemedicine care model provides direct patient access to providers through a web portal or app, without referrals from a primary physician or via insurance or managed care.

Dr. Edison, chair of the department of dermatology at the University of Missouri–Columbia, a study coauthor with over 20 years of teledermatology experience, said that she herself has recently begun seeing established patients live via video conferencing, with several successful “e-visit” experiences over the last several months.

In addition, she has about 3 years’ experience in“store-and-forward” teledermatology, where notes and relevant clinical images from an office visit are forwarded to a specialist, who then initiates a clinician-to-clinician consult to provide expertise in difficult cases or when resources are lacking. Live interactive and store-and-forward teledermatology have both been shown to be reliable for diagnosis and management, based on a “large body of evidence,” said Dr. Edison, citing a 2015 American Telemedicine Association statement.

However, the reliability of DTC care has been less well studied, she pointed out.

In an interview, Jack Resneck Jr., MD, the study’s lead author, agreed. “Physicians by our nature are innovators and will embrace new technologies whose quality and value are proven, but DTC telehealth isn’t there yet,” said Dr. Resneck, professor and vice-chair of dermatology, at the University of California, San Francisco.

To simulate a realistic patient experience and assess aspects of quality of care in DTC teledermatology, he, Dr. Edison, and their coinvestigators devised a study that had study personnel pose as patients to seek care for one of six skin conditions. They limited e-visits to websites or apps that offered services to California residents and excluded sites that required an interactive video visit, or that served patients insured by a particular insurance company or by a particular brick-and-mortar health care organization.

The “patients” initially submitted a universal history of present illness for a given condition, and had up to three photos available for submission. They also had supplemental medical history and review of systems information available that they would provide only if prompted by the provider.

A total of 16 telemedicine sites received a total of 62 submissions from the study personnel. Security issues arose almost immediately, Dr. Edison said at the meeting. “No site asked for photo ID or attempted to confirm identity,” and no site attempted to verify the authenticity of the submitted photos.

Twenty-seven of the providers were dermatologists, and an additional eight were internal medicine or family practice physicians. The remainder came from a variety of specialties. Six visits were conducted by seven nonphysician providers (three physician assistants from dermatology settings, and four nondermatology nurse practitioners).

When it came to the actual patient encounter, only one in three clinicians asked for a review of previous symptoms or a pertinent review of systems. “None asked relevant follow-up questions,” Dr. Edison said. Just under half of the providers asked female patients whether they could be pregnant or were lactating. Of the 14 encounters where pregnancy category C or higher drugs were prescribed, six providers (43%) discussed pregnancy risk.

For four of the simulated patient encounters, clinicians diagnosed a skin condition without asking for any photographs. No patients were referred for laboratory testing.

One of the cases was a 28-year-old woman who described a long history of inflammatory acne; the additional information, which no site requested, was that the patient also had hypertrichosis and irregular menses, as well as a mother with diabetes. This history would have led to a polycystic ovarian syndrome (PCOS) diagnosis, had it been elicited.

This was one of many such instances, and, in addition to PCOS, major diagnoses were missed, including secondary syphilis, eczema herpeticum, and gram-negative folliculitis.

Issues of transparency also arose: In two-thirds of the encounters, clinicians were assigned with no opportunity for patient input or choice. Licensure information was provided by about a quarter of providers overall. Of the U.S.-licensed physicians, just under half provided their board certification status. “Patient choice of their treating physician is part of our medical code of ethics, and we were surprised that these websites with multiple clinicians on staff assigned a clinician without patient choice in most encounters,” they added.

Telemedicine services provided the clinician’s geographic location in 61% of the encounters, and the investigators were able to identify the location of the clinician for 57 encounters. Of these, 35 were within the state of California, six were in India, and two were in Sweden; the rest were in other U.S. states. “Despite claims that they were not providing health care services, we believe that two DTC telemedicine websites headquartered in California but using foreign clinicians were engaged in the practice of medicine without a state license, as they clearly provided diagnoses and treatment recommendations,” they pointed out.

The geographic spread between patient and provider may have contributed to the lack of care coordination seen in the study, Dr. Resneck said in the interview, noting that most DTC providers “didn’t offer to send records to a patient’s existing local doctors.” When complications or follow-up care are needed, he added, “those distant clinicians often don’t have local contacts and are unable to facilitate needed appointments.”

In the study, the authors acknowledged a significant limitation of the study, their inability to “assess whether clinicians seeing these patients in traditional in-person encounters would have performed better on diagnostic accuracy.” However, they felt that their experience showed that the additional data that would have led to a correct diagnosis “typically emerge in the give-and-take of obtaining a history in the office setting.”

Telemedicine in all its forms can be expected to grow. At the meeting, Dr. Edison said that recently, the Stage 2 Meaningful Use requirement that at least 5% of a practice’s patients send a secure electronic message to their provider has been an impetus for increased adoption of teledermatology. And that can be a good thing. “Early access to our expertise saves patients from suffering, saves lives, and saves money,” she commented.

For Dr. Resneck, the early access should be part of the patient’s existing network of care, when possible, and he’s frustrated by the lack of continuity his study highlighted. “Many insurers are currently contracting with the fragmented DTC services we studied for their enrollees, while refusing to cover follow-up telehealth visits with a patient’s existing doctors, and that’s a problem,” he said.

Quality can’t be sacrificed for easy access, Dr. Edison agreed. “The same standard of care applies in teledermatology as in in-person health care,” she said.

Dr. Edison said that study personnel did not falsify their identities, and no prescriptions were actually filled. The visits were paid for by prepaid debit cards funded by the American Academy of Dermatology (study personnel claimed to be uninsured). Dr. Resneck serves on the board of the American Medical Association, and both Dr. Resneck and Dr. Edison serve on the AAD’s Telemedicine Task Force.

[email protected]

On Twitter @karioakes

MINNEAPOLIS – Missed diagnoses, lack of care coordination, and security concerns were among the gaps in care that appeared when research personnel with simulated skin problems used direct-to-consumer (DTC) sites for telemedicine consults in a recently published study that highlighted potential drawbacks of this technology.

While telemedicine “has potential to expand access, and the medical literature is filled with examples of telehealth systems providing quality care,” the authors of the study concluded, their results “raise doubts about the quality of skin disease diagnosis and treatment being provided by a variety of DTC telemedicine websites and apps” (JAMA Dermatol. 2016;152[7]:768-775).

Karen Edison, MD, a dermatologist and telemedicine pioneer, shared results of the study that addressed the quality of DTC teledermatology, a rapidly growing market, at the annual meeting of the Society for Pediatric Dermatology. The DTC telemedicine care model provides direct patient access to providers through a web portal or app, without referrals from a primary physician or via insurance or managed care.

Dr. Edison, chair of the department of dermatology at the University of Missouri–Columbia, a study coauthor with over 20 years of teledermatology experience, said that she herself has recently begun seeing established patients live via video conferencing, with several successful “e-visit” experiences over the last several months.

In addition, she has about 3 years’ experience in“store-and-forward” teledermatology, where notes and relevant clinical images from an office visit are forwarded to a specialist, who then initiates a clinician-to-clinician consult to provide expertise in difficult cases or when resources are lacking. Live interactive and store-and-forward teledermatology have both been shown to be reliable for diagnosis and management, based on a “large body of evidence,” said Dr. Edison, citing a 2015 American Telemedicine Association statement.

However, the reliability of DTC care has been less well studied, she pointed out.

In an interview, Jack Resneck Jr., MD, the study’s lead author, agreed. “Physicians by our nature are innovators and will embrace new technologies whose quality and value are proven, but DTC telehealth isn’t there yet,” said Dr. Resneck, professor and vice-chair of dermatology, at the University of California, San Francisco.

To simulate a realistic patient experience and assess aspects of quality of care in DTC teledermatology, he, Dr. Edison, and their coinvestigators devised a study that had study personnel pose as patients to seek care for one of six skin conditions. They limited e-visits to websites or apps that offered services to California residents and excluded sites that required an interactive video visit, or that served patients insured by a particular insurance company or by a particular brick-and-mortar health care organization.

The “patients” initially submitted a universal history of present illness for a given condition, and had up to three photos available for submission. They also had supplemental medical history and review of systems information available that they would provide only if prompted by the provider.

A total of 16 telemedicine sites received a total of 62 submissions from the study personnel. Security issues arose almost immediately, Dr. Edison said at the meeting. “No site asked for photo ID or attempted to confirm identity,” and no site attempted to verify the authenticity of the submitted photos.

Twenty-seven of the providers were dermatologists, and an additional eight were internal medicine or family practice physicians. The remainder came from a variety of specialties. Six visits were conducted by seven nonphysician providers (three physician assistants from dermatology settings, and four nondermatology nurse practitioners).

When it came to the actual patient encounter, only one in three clinicians asked for a review of previous symptoms or a pertinent review of systems. “None asked relevant follow-up questions,” Dr. Edison said. Just under half of the providers asked female patients whether they could be pregnant or were lactating. Of the 14 encounters where pregnancy category C or higher drugs were prescribed, six providers (43%) discussed pregnancy risk.

For four of the simulated patient encounters, clinicians diagnosed a skin condition without asking for any photographs. No patients were referred for laboratory testing.

One of the cases was a 28-year-old woman who described a long history of inflammatory acne; the additional information, which no site requested, was that the patient also had hypertrichosis and irregular menses, as well as a mother with diabetes. This history would have led to a polycystic ovarian syndrome (PCOS) diagnosis, had it been elicited.

This was one of many such instances, and, in addition to PCOS, major diagnoses were missed, including secondary syphilis, eczema herpeticum, and gram-negative folliculitis.

Issues of transparency also arose: In two-thirds of the encounters, clinicians were assigned with no opportunity for patient input or choice. Licensure information was provided by about a quarter of providers overall. Of the U.S.-licensed physicians, just under half provided their board certification status. “Patient choice of their treating physician is part of our medical code of ethics, and we were surprised that these websites with multiple clinicians on staff assigned a clinician without patient choice in most encounters,” they added.

Telemedicine services provided the clinician’s geographic location in 61% of the encounters, and the investigators were able to identify the location of the clinician for 57 encounters. Of these, 35 were within the state of California, six were in India, and two were in Sweden; the rest were in other U.S. states. “Despite claims that they were not providing health care services, we believe that two DTC telemedicine websites headquartered in California but using foreign clinicians were engaged in the practice of medicine without a state license, as they clearly provided diagnoses and treatment recommendations,” they pointed out.

The geographic spread between patient and provider may have contributed to the lack of care coordination seen in the study, Dr. Resneck said in the interview, noting that most DTC providers “didn’t offer to send records to a patient’s existing local doctors.” When complications or follow-up care are needed, he added, “those distant clinicians often don’t have local contacts and are unable to facilitate needed appointments.”

In the study, the authors acknowledged a significant limitation of the study, their inability to “assess whether clinicians seeing these patients in traditional in-person encounters would have performed better on diagnostic accuracy.” However, they felt that their experience showed that the additional data that would have led to a correct diagnosis “typically emerge in the give-and-take of obtaining a history in the office setting.”

Telemedicine in all its forms can be expected to grow. At the meeting, Dr. Edison said that recently, the Stage 2 Meaningful Use requirement that at least 5% of a practice’s patients send a secure electronic message to their provider has been an impetus for increased adoption of teledermatology. And that can be a good thing. “Early access to our expertise saves patients from suffering, saves lives, and saves money,” she commented.

For Dr. Resneck, the early access should be part of the patient’s existing network of care, when possible, and he’s frustrated by the lack of continuity his study highlighted. “Many insurers are currently contracting with the fragmented DTC services we studied for their enrollees, while refusing to cover follow-up telehealth visits with a patient’s existing doctors, and that’s a problem,” he said.

Quality can’t be sacrificed for easy access, Dr. Edison agreed. “The same standard of care applies in teledermatology as in in-person health care,” she said.

Dr. Edison said that study personnel did not falsify their identities, and no prescriptions were actually filled. The visits were paid for by prepaid debit cards funded by the American Academy of Dermatology (study personnel claimed to be uninsured). Dr. Resneck serves on the board of the American Medical Association, and both Dr. Resneck and Dr. Edison serve on the AAD’s Telemedicine Task Force.

[email protected]

On Twitter @karioakes

MINNEAPOLIS – Missed diagnoses, lack of care coordination, and security concerns were among the gaps in care that appeared when research personnel with simulated skin problems used direct-to-consumer (DTC) sites for telemedicine consults in a recently published study that highlighted potential drawbacks of this technology.

While telemedicine “has potential to expand access, and the medical literature is filled with examples of telehealth systems providing quality care,” the authors of the study concluded, their results “raise doubts about the quality of skin disease diagnosis and treatment being provided by a variety of DTC telemedicine websites and apps” (JAMA Dermatol. 2016;152[7]:768-775).

Karen Edison, MD, a dermatologist and telemedicine pioneer, shared results of the study that addressed the quality of DTC teledermatology, a rapidly growing market, at the annual meeting of the Society for Pediatric Dermatology. The DTC telemedicine care model provides direct patient access to providers through a web portal or app, without referrals from a primary physician or via insurance or managed care.

Dr. Edison, chair of the department of dermatology at the University of Missouri–Columbia, a study coauthor with over 20 years of teledermatology experience, said that she herself has recently begun seeing established patients live via video conferencing, with several successful “e-visit” experiences over the last several months.

In addition, she has about 3 years’ experience in“store-and-forward” teledermatology, where notes and relevant clinical images from an office visit are forwarded to a specialist, who then initiates a clinician-to-clinician consult to provide expertise in difficult cases or when resources are lacking. Live interactive and store-and-forward teledermatology have both been shown to be reliable for diagnosis and management, based on a “large body of evidence,” said Dr. Edison, citing a 2015 American Telemedicine Association statement.

However, the reliability of DTC care has been less well studied, she pointed out.

In an interview, Jack Resneck Jr., MD, the study’s lead author, agreed. “Physicians by our nature are innovators and will embrace new technologies whose quality and value are proven, but DTC telehealth isn’t there yet,” said Dr. Resneck, professor and vice-chair of dermatology, at the University of California, San Francisco.

To simulate a realistic patient experience and assess aspects of quality of care in DTC teledermatology, he, Dr. Edison, and their coinvestigators devised a study that had study personnel pose as patients to seek care for one of six skin conditions. They limited e-visits to websites or apps that offered services to California residents and excluded sites that required an interactive video visit, or that served patients insured by a particular insurance company or by a particular brick-and-mortar health care organization.

The “patients” initially submitted a universal history of present illness for a given condition, and had up to three photos available for submission. They also had supplemental medical history and review of systems information available that they would provide only if prompted by the provider.

A total of 16 telemedicine sites received a total of 62 submissions from the study personnel. Security issues arose almost immediately, Dr. Edison said at the meeting. “No site asked for photo ID or attempted to confirm identity,” and no site attempted to verify the authenticity of the submitted photos.

Twenty-seven of the providers were dermatologists, and an additional eight were internal medicine or family practice physicians. The remainder came from a variety of specialties. Six visits were conducted by seven nonphysician providers (three physician assistants from dermatology settings, and four nondermatology nurse practitioners).

When it came to the actual patient encounter, only one in three clinicians asked for a review of previous symptoms or a pertinent review of systems. “None asked relevant follow-up questions,” Dr. Edison said. Just under half of the providers asked female patients whether they could be pregnant or were lactating. Of the 14 encounters where pregnancy category C or higher drugs were prescribed, six providers (43%) discussed pregnancy risk.

For four of the simulated patient encounters, clinicians diagnosed a skin condition without asking for any photographs. No patients were referred for laboratory testing.

One of the cases was a 28-year-old woman who described a long history of inflammatory acne; the additional information, which no site requested, was that the patient also had hypertrichosis and irregular menses, as well as a mother with diabetes. This history would have led to a polycystic ovarian syndrome (PCOS) diagnosis, had it been elicited.

This was one of many such instances, and, in addition to PCOS, major diagnoses were missed, including secondary syphilis, eczema herpeticum, and gram-negative folliculitis.

Issues of transparency also arose: In two-thirds of the encounters, clinicians were assigned with no opportunity for patient input or choice. Licensure information was provided by about a quarter of providers overall. Of the U.S.-licensed physicians, just under half provided their board certification status. “Patient choice of their treating physician is part of our medical code of ethics, and we were surprised that these websites with multiple clinicians on staff assigned a clinician without patient choice in most encounters,” they added.

Telemedicine services provided the clinician’s geographic location in 61% of the encounters, and the investigators were able to identify the location of the clinician for 57 encounters. Of these, 35 were within the state of California, six were in India, and two were in Sweden; the rest were in other U.S. states. “Despite claims that they were not providing health care services, we believe that two DTC telemedicine websites headquartered in California but using foreign clinicians were engaged in the practice of medicine without a state license, as they clearly provided diagnoses and treatment recommendations,” they pointed out.

The geographic spread between patient and provider may have contributed to the lack of care coordination seen in the study, Dr. Resneck said in the interview, noting that most DTC providers “didn’t offer to send records to a patient’s existing local doctors.” When complications or follow-up care are needed, he added, “those distant clinicians often don’t have local contacts and are unable to facilitate needed appointments.”

In the study, the authors acknowledged a significant limitation of the study, their inability to “assess whether clinicians seeing these patients in traditional in-person encounters would have performed better on diagnostic accuracy.” However, they felt that their experience showed that the additional data that would have led to a correct diagnosis “typically emerge in the give-and-take of obtaining a history in the office setting.”

Telemedicine in all its forms can be expected to grow. At the meeting, Dr. Edison said that recently, the Stage 2 Meaningful Use requirement that at least 5% of a practice’s patients send a secure electronic message to their provider has been an impetus for increased adoption of teledermatology. And that can be a good thing. “Early access to our expertise saves patients from suffering, saves lives, and saves money,” she commented.

For Dr. Resneck, the early access should be part of the patient’s existing network of care, when possible, and he’s frustrated by the lack of continuity his study highlighted. “Many insurers are currently contracting with the fragmented DTC services we studied for their enrollees, while refusing to cover follow-up telehealth visits with a patient’s existing doctors, and that’s a problem,” he said.

Quality can’t be sacrificed for easy access, Dr. Edison agreed. “The same standard of care applies in teledermatology as in in-person health care,” she said.

Dr. Edison said that study personnel did not falsify their identities, and no prescriptions were actually filled. The visits were paid for by prepaid debit cards funded by the American Academy of Dermatology (study personnel claimed to be uninsured). Dr. Resneck serves on the board of the American Medical Association, and both Dr. Resneck and Dr. Edison serve on the AAD’s Telemedicine Task Force.

[email protected]

On Twitter @karioakes

Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).

Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.

Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.

How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.

For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.

You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.

How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.

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].

Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).

Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.

Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.

How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.

For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.

You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.

How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.

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].

Given the bewildering array of new bureaucracies that private practices have been forced to contend with in recent years, it’s easy to forget about the older ones – especially OSHA (Occupational Safety and Health Administration).

Now would be a good time – before the new year begins, and you’re forced to take on the MACRA meshugas, which I’ll discuss next month – to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

I’m always amazed at how many offices lack an official OSHA poster, enumerating employee rights and explaining how to file complaints; it’s the first thing an OSHA inspector looks for. You can download one from OSHA’s website, or order it at no charge by calling 800-321-OSHA.

Next, check out your building’s exits. Everyone must be able to evacuate your office quickly in case of fire or other emergencies. At minimum, you (or the owner of the building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Now, review your list of hazardous chemicals, which all employees have a right to know about. Keep in mind that OSHA’s list contains many substances – alcohol, disinfectants, even hydrogen peroxide – that you might not consider particularly dangerous but must nevertheless be on your written list of hazardous chemicals. For each of these, your employees must also have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific substance and for handling and containing it in a spill or other emergency.

How old is your written exposure control plan for blood-borne pathogens? It should document your use of such protective equipment as gloves, face and eye protection, and gowns, and your implementation of universal precautions – and it’s supposed to be updated annually, to reflect changes in technology. You need not adopt every new safety device as it comes on the market, but you should document which ones you are using, and why.

For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at your decision and what you plan to use instead.

You must provide all at-risk employees with hepatitis B vaccine, at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

Other components of the rule include proper containment of regulated medical waste, identification of regulated waste containers, sharps disposal boxes, and periodic employee training regarding all of those things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have such a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars.

How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you want to do that? Because in return for agreeing to have your office inspected, OSHA will agree not to cite you for any violations they find, as long as you fix them.

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].

The novel glucagonlike peptide 1 (GLP-1) receptor agonist semaglutide may reduce the risk of cardiovascular events in patients with type 2 diabetes who are at elevated cardiovascular risk, according to data presented Sept. 16 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published online in the New England Journal of Medicine.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Steven P. Marso, MD, and his coinvestigators.

SUSTAIN-6 was a randomized, placebo-controlled, noninferiority trial in which 3,297 patients with type 2 diabetes, 85% of whom had established cardiovascular disease, were assigned to take either once-weekly semaglutide (0.5 mg or 1 mg) or placebo.

At the end of the 2-year study period, patients on semaglutide had a statistically significant, 26% lower risk of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, the study’s primary composite outcome, compared with those on placebo (P less than .001), Dr. Marso and his associates wrote. This outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group and in 146 of 1,649 patients (8.9%) in the placebo group.

Specifically, the study showed a 26% reduction in the risk of nonfatal MI (P = .12) and 39% reduction in nonfatal stroke (P = .04) with semaglutide, while the rates of cardiovascular death and heart failure hospitalizations were similar between the two arms of the study.

Overall, 60.5% of the patients in the study had a history of cardiovascular disease, and nearly one-third had a history of MI (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMoa1607141).

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Dr. Marso of the Research Medical Center in Kansas City, Mo., and coauthors. “The beneficial effect of semaglutide on cardiovascular outcomes may relate to modification of the progression of atherosclerosis.”

Semaglutide has a longer duration of action than the approved GLP-1 receptor agonists – liraglutide, exenatide, albiglutide, dulaglutide, and lixisenatide – allowing for once-weekly subcutaneous injection.

Patients enrolled in the study were all on a standard care regimen, but those taking semaglutide showed significant and sustained reductions in hemoglobin A_1c levels, compared with placebo, as well as a higher incidence of clinically meaningful and sustained weight loss, and reductions in systolic blood pressure.

The reductions in HbA_1c, body weight, and systolic blood pressure may all have contributed to the observed reduction in cardiovascular risk with semaglutide,” the authors noted.

The study did observe significantly higher rates of diabetic retinopathy complications in patients taking semaglutide. The overall incidence of these complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) of the placebo patients, yielding a hazard ratio of 1.76 (P = .02). More patients in the semaglutide group required retinal photocoagulation or the use of an intravitreal agent, had a vitreous hemorrhage, or had developed diabetes-related blindness.

However, patients taking semaglutide also had a 36% lower incidence of new or worsening nephropathy (P = .005), and the frequency of serious adverse events was also lower in the semaglutide group than in the placebo patients.

“With the exception of complications of retinopathy, semaglutide had a safety profile similar to that of other GLP-1 receptor agonists,” the authors reported. The rates of malignant neoplasms were similar in both arms of the study, and the rate of pancreatic cancer, which is known to be an event of interest for this class of drugs, was lower in the semaglutide arm, compared with placebo.

Semaglutide is in development and not yet approved for the treatment of type 2 diabetes.

Starting in 2008, all new drug applications to the Food and Drug Administration for antihyperglycemic agents must include evidence that therapy will not increase the risk of cardiovascular events; SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects with Type 2 Diabetes) was designed to fill that need for semaglutide, and is being developed by Novo Nordisk.

The study was supported by Novo Nordisk. Thirteen authors declared consultancies, grants, fees, and other support from pharmaceutical companies, including Novo Nordisk, and three authors were employees of Novo Nordisk.

The novel glucagonlike peptide 1 (GLP-1) receptor agonist semaglutide may reduce the risk of cardiovascular events in patients with type 2 diabetes who are at elevated cardiovascular risk, according to data presented Sept. 16 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published online in the New England Journal of Medicine.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Steven P. Marso, MD, and his coinvestigators.

SUSTAIN-6 was a randomized, placebo-controlled, noninferiority trial in which 3,297 patients with type 2 diabetes, 85% of whom had established cardiovascular disease, were assigned to take either once-weekly semaglutide (0.5 mg or 1 mg) or placebo.

At the end of the 2-year study period, patients on semaglutide had a statistically significant, 26% lower risk of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, the study’s primary composite outcome, compared with those on placebo (P less than .001), Dr. Marso and his associates wrote. This outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group and in 146 of 1,649 patients (8.9%) in the placebo group.

Specifically, the study showed a 26% reduction in the risk of nonfatal MI (P = .12) and 39% reduction in nonfatal stroke (P = .04) with semaglutide, while the rates of cardiovascular death and heart failure hospitalizations were similar between the two arms of the study.

Overall, 60.5% of the patients in the study had a history of cardiovascular disease, and nearly one-third had a history of MI (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMoa1607141).

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Dr. Marso of the Research Medical Center in Kansas City, Mo., and coauthors. “The beneficial effect of semaglutide on cardiovascular outcomes may relate to modification of the progression of atherosclerosis.”

Semaglutide has a longer duration of action than the approved GLP-1 receptor agonists – liraglutide, exenatide, albiglutide, dulaglutide, and lixisenatide – allowing for once-weekly subcutaneous injection.

Patients enrolled in the study were all on a standard care regimen, but those taking semaglutide showed significant and sustained reductions in hemoglobin A_1c levels, compared with placebo, as well as a higher incidence of clinically meaningful and sustained weight loss, and reductions in systolic blood pressure.

The reductions in HbA_1c, body weight, and systolic blood pressure may all have contributed to the observed reduction in cardiovascular risk with semaglutide,” the authors noted.

The study did observe significantly higher rates of diabetic retinopathy complications in patients taking semaglutide. The overall incidence of these complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) of the placebo patients, yielding a hazard ratio of 1.76 (P = .02). More patients in the semaglutide group required retinal photocoagulation or the use of an intravitreal agent, had a vitreous hemorrhage, or had developed diabetes-related blindness.

However, patients taking semaglutide also had a 36% lower incidence of new or worsening nephropathy (P = .005), and the frequency of serious adverse events was also lower in the semaglutide group than in the placebo patients.

“With the exception of complications of retinopathy, semaglutide had a safety profile similar to that of other GLP-1 receptor agonists,” the authors reported. The rates of malignant neoplasms were similar in both arms of the study, and the rate of pancreatic cancer, which is known to be an event of interest for this class of drugs, was lower in the semaglutide arm, compared with placebo.

Semaglutide is in development and not yet approved for the treatment of type 2 diabetes.

Starting in 2008, all new drug applications to the Food and Drug Administration for antihyperglycemic agents must include evidence that therapy will not increase the risk of cardiovascular events; SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects with Type 2 Diabetes) was designed to fill that need for semaglutide, and is being developed by Novo Nordisk.

The study was supported by Novo Nordisk. Thirteen authors declared consultancies, grants, fees, and other support from pharmaceutical companies, including Novo Nordisk, and three authors were employees of Novo Nordisk.

The novel glucagonlike peptide 1 (GLP-1) receptor agonist semaglutide may reduce the risk of cardiovascular events in patients with type 2 diabetes who are at elevated cardiovascular risk, according to data presented Sept. 16 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published online in the New England Journal of Medicine.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Steven P. Marso, MD, and his coinvestigators.

SUSTAIN-6 was a randomized, placebo-controlled, noninferiority trial in which 3,297 patients with type 2 diabetes, 85% of whom had established cardiovascular disease, were assigned to take either once-weekly semaglutide (0.5 mg or 1 mg) or placebo.

At the end of the 2-year study period, patients on semaglutide had a statistically significant, 26% lower risk of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, the study’s primary composite outcome, compared with those on placebo (P less than .001), Dr. Marso and his associates wrote. This outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group and in 146 of 1,649 patients (8.9%) in the placebo group.

Specifically, the study showed a 26% reduction in the risk of nonfatal MI (P = .12) and 39% reduction in nonfatal stroke (P = .04) with semaglutide, while the rates of cardiovascular death and heart failure hospitalizations were similar between the two arms of the study.

Overall, 60.5% of the patients in the study had a history of cardiovascular disease, and nearly one-third had a history of MI (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMoa1607141).

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide,” wrote Dr. Marso of the Research Medical Center in Kansas City, Mo., and coauthors. “The beneficial effect of semaglutide on cardiovascular outcomes may relate to modification of the progression of atherosclerosis.”

Semaglutide has a longer duration of action than the approved GLP-1 receptor agonists – liraglutide, exenatide, albiglutide, dulaglutide, and lixisenatide – allowing for once-weekly subcutaneous injection.

Patients enrolled in the study were all on a standard care regimen, but those taking semaglutide showed significant and sustained reductions in hemoglobin A_1c levels, compared with placebo, as well as a higher incidence of clinically meaningful and sustained weight loss, and reductions in systolic blood pressure.

The reductions in HbA_1c, body weight, and systolic blood pressure may all have contributed to the observed reduction in cardiovascular risk with semaglutide,” the authors noted.

The study did observe significantly higher rates of diabetic retinopathy complications in patients taking semaglutide. The overall incidence of these complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) of the placebo patients, yielding a hazard ratio of 1.76 (P = .02). More patients in the semaglutide group required retinal photocoagulation or the use of an intravitreal agent, had a vitreous hemorrhage, or had developed diabetes-related blindness.

However, patients taking semaglutide also had a 36% lower incidence of new or worsening nephropathy (P = .005), and the frequency of serious adverse events was also lower in the semaglutide group than in the placebo patients.

“With the exception of complications of retinopathy, semaglutide had a safety profile similar to that of other GLP-1 receptor agonists,” the authors reported. The rates of malignant neoplasms were similar in both arms of the study, and the rate of pancreatic cancer, which is known to be an event of interest for this class of drugs, was lower in the semaglutide arm, compared with placebo.

Semaglutide is in development and not yet approved for the treatment of type 2 diabetes.

Starting in 2008, all new drug applications to the Food and Drug Administration for antihyperglycemic agents must include evidence that therapy will not increase the risk of cardiovascular events; SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects with Type 2 Diabetes) was designed to fill that need for semaglutide, and is being developed by Novo Nordisk.

The study was supported by Novo Nordisk. Thirteen authors declared consultancies, grants, fees, and other support from pharmaceutical companies, including Novo Nordisk, and three authors were employees of Novo Nordisk.

An analysis of 27 studies involving over 3000 patients with drug resistant temporal lobe epilepsy has shed light on the value of various type of neuroimaging. Seven studies suggest that clinical outcomes are more favorable when patients have MRI-identified hippocampal atrophy and mesial temporal sclerosis. On the other hand, 5 studies concluded that outcomes were less favorable when patients had unremarkable MIR findings. The value of PET imaging seems less clear. Study findings were inconsistent on the prognostic value of PET-identified focal hypometabolism, for instance.    

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016;73(4):464-470.

An analysis of 27 studies involving over 3000 patients with drug resistant temporal lobe epilepsy has shed light on the value of various type of neuroimaging. Seven studies suggest that clinical outcomes are more favorable when patients have MRI-identified hippocampal atrophy and mesial temporal sclerosis. On the other hand, 5 studies concluded that outcomes were less favorable when patients had unremarkable MIR findings. The value of PET imaging seems less clear. Study findings were inconsistent on the prognostic value of PET-identified focal hypometabolism, for instance.    

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016;73(4):464-470.

An analysis of 27 studies involving over 3000 patients with drug resistant temporal lobe epilepsy has shed light on the value of various type of neuroimaging. Seven studies suggest that clinical outcomes are more favorable when patients have MRI-identified hippocampal atrophy and mesial temporal sclerosis. On the other hand, 5 studies concluded that outcomes were less favorable when patients had unremarkable MIR findings. The value of PET imaging seems less clear. Study findings were inconsistent on the prognostic value of PET-identified focal hypometabolism, for instance.    

Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016;73(4):464-470.

In an effort to detect links between seizure clusters and as yet unknown clinical factors among patients with drug-resistant focal epilepsy, researchers performed a retrospective analysis of 764 patients. They found clustering in 23.6% of patients with temporal lobe epilepsy (TLE) and 16.9% of patients with extratemporal seizures. Unfortunately, they failed to detect any clinical factors associated with the clustering. However, they did notice that TLE patients fared better after surgery if they had a history of seizure clusters.

Asadi-Pooya AA, Nei M, Sharan A, Sperling MR. Seizure clusters in drug-resistant focal epilepsy. Epilepsia. 2016;57(9):e187-e190.

In an effort to detect links between seizure clusters and as yet unknown clinical factors among patients with drug-resistant focal epilepsy, researchers performed a retrospective analysis of 764 patients. They found clustering in 23.6% of patients with temporal lobe epilepsy (TLE) and 16.9% of patients with extratemporal seizures. Unfortunately, they failed to detect any clinical factors associated with the clustering. However, they did notice that TLE patients fared better after surgery if they had a history of seizure clusters.

Asadi-Pooya AA, Nei M, Sharan A, Sperling MR. Seizure clusters in drug-resistant focal epilepsy. Epilepsia. 2016;57(9):e187-e190.

In an effort to detect links between seizure clusters and as yet unknown clinical factors among patients with drug-resistant focal epilepsy, researchers performed a retrospective analysis of 764 patients. They found clustering in 23.6% of patients with temporal lobe epilepsy (TLE) and 16.9% of patients with extratemporal seizures. Unfortunately, they failed to detect any clinical factors associated with the clustering. However, they did notice that TLE patients fared better after surgery if they had a history of seizure clusters.

Asadi-Pooya AA, Nei M, Sharan A, Sperling MR. Seizure clusters in drug-resistant focal epilepsy. Epilepsia. 2016;57(9):e187-e190.

Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.

Balter S, Lin G, Leyden KM, Paul BM, McDonald CR. Neuroimaging correlates of language network impairment and reorganization in temporal lobe epilepsy. Brain Lang. 2016:pii S0093-934X(15)30127-9.

Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.

Balter S, Lin G, Leyden KM, Paul BM, McDonald CR. Neuroimaging correlates of language network impairment and reorganization in temporal lobe epilepsy. Brain Lang. 2016:pii S0093-934X(15)30127-9.

Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.Functional magnetic resonance imaging (fMRI), volumetric MRI, and diffusion tensor imaging are providing new insights into the epileptic brain, according to a recent review of the research literature from Balter et al. fMRI, for instance, is improving clinicians’ understanding of how patients with epilepsy organize and reorganize the complexities of language before and after surgery. Volumetric MRI and diffusion tensor imaging are giving investigators insights into how patients with various epilepsy syndromes cope with language dysfunction by allowing the researchers to visualize structural and microsctructural changes associated with these syndromes. The literature review also discusses the value of new analytic techniques like graph theory to better understand abnormal brain connectivity in this patient population.

Balter S, Lin G, Leyden KM, Paul BM, McDonald CR. Neuroimaging correlates of language network impairment and reorganization in temporal lobe epilepsy. Brain Lang. 2016:pii S0093-934X(15)30127-9.