Heidi Splete

Laser treatment is effective against nongenital cutaneous warts, based on data from a review of 35 studies comprising 2,149 adult patients.

“No monotherapy has achieved completed remission [of nongenital cutaneous warts] in every case,” wrote Jannett Nguyen, a medical student at the University of California, Irvine, and colleagues (JAMA Dermatol. 2016 April 27. doi: 10.1001/jamadermatol.2016.0826).

The researchers reviewed data on warts treated with one of four types of lasers: Carbon dioxide (CO₂), erbium:yttrium-aluminum-garnet (Er:YAG), pulsed dye laser (PDL), or neodymium-doped yttrium aluminum garnet (Nd:YAG).

The response rates for the different lasers were 50%-100% for CO₂, 72%-100% for Er:YAG, 31%-100% for PDL, and 46%-100% for Nd:YAG. The studies included data on laser treatment of several types of nongenital warts including simple and recalcitrant common warts, periungual and subungual warts, and palmoplantar warts.

In general, side effects from laser treatment of warts were highest with CO₂ lasers, and included scarring, hypopigmentation, postoperative pain, and prolonged wound healing. PDL was associated with the lowest risk of side effects, and was as effective as conventional therapies, including cryotherapy and cantharidin.

In Er:YAG treatments, the laser was used for direct ablation of the epidermis on the wart, repeating through layers until normal skin is revealed. Overall, patients treated with Er:YAG demonstrated a higher response and lower recurrence when treated in combination with podofilox. Nd:YAG treatment was similar to PDL, but with a longer wavelength that allows for deeper penetration.

Treatment is limited by a lack of evidence to guide selection of the most appropriate lasers for different warts and by a lack of recommendations for specific laser settings, the researchers noted. Additional studies are needed to establish treatment protocols by comparing lasers to each other and to nonlaser treatments.

However, laser treatment of warts can be “an additional therapeutic option and the studies reviewed here can provide a starting point in determining settings,” they said.

The researchers had no financial disclosures.

Laser treatment is effective against nongenital cutaneous warts, based on data from a review of 35 studies comprising 2,149 adult patients.

“No monotherapy has achieved completed remission [of nongenital cutaneous warts] in every case,” wrote Jannett Nguyen, a medical student at the University of California, Irvine, and colleagues (JAMA Dermatol. 2016 April 27. doi: 10.1001/jamadermatol.2016.0826).

The researchers reviewed data on warts treated with one of four types of lasers: Carbon dioxide (CO₂), erbium:yttrium-aluminum-garnet (Er:YAG), pulsed dye laser (PDL), or neodymium-doped yttrium aluminum garnet (Nd:YAG).

The response rates for the different lasers were 50%-100% for CO₂, 72%-100% for Er:YAG, 31%-100% for PDL, and 46%-100% for Nd:YAG. The studies included data on laser treatment of several types of nongenital warts including simple and recalcitrant common warts, periungual and subungual warts, and palmoplantar warts.

In general, side effects from laser treatment of warts were highest with CO₂ lasers, and included scarring, hypopigmentation, postoperative pain, and prolonged wound healing. PDL was associated with the lowest risk of side effects, and was as effective as conventional therapies, including cryotherapy and cantharidin.

In Er:YAG treatments, the laser was used for direct ablation of the epidermis on the wart, repeating through layers until normal skin is revealed. Overall, patients treated with Er:YAG demonstrated a higher response and lower recurrence when treated in combination with podofilox. Nd:YAG treatment was similar to PDL, but with a longer wavelength that allows for deeper penetration.

Treatment is limited by a lack of evidence to guide selection of the most appropriate lasers for different warts and by a lack of recommendations for specific laser settings, the researchers noted. Additional studies are needed to establish treatment protocols by comparing lasers to each other and to nonlaser treatments.

However, laser treatment of warts can be “an additional therapeutic option and the studies reviewed here can provide a starting point in determining settings,” they said.

The researchers had no financial disclosures.

Laser treatment is effective against nongenital cutaneous warts, based on data from a review of 35 studies comprising 2,149 adult patients.

“No monotherapy has achieved completed remission [of nongenital cutaneous warts] in every case,” wrote Jannett Nguyen, a medical student at the University of California, Irvine, and colleagues (JAMA Dermatol. 2016 April 27. doi: 10.1001/jamadermatol.2016.0826).

The researchers reviewed data on warts treated with one of four types of lasers: Carbon dioxide (CO₂), erbium:yttrium-aluminum-garnet (Er:YAG), pulsed dye laser (PDL), or neodymium-doped yttrium aluminum garnet (Nd:YAG).

The response rates for the different lasers were 50%-100% for CO₂, 72%-100% for Er:YAG, 31%-100% for PDL, and 46%-100% for Nd:YAG. The studies included data on laser treatment of several types of nongenital warts including simple and recalcitrant common warts, periungual and subungual warts, and palmoplantar warts.

In general, side effects from laser treatment of warts were highest with CO₂ lasers, and included scarring, hypopigmentation, postoperative pain, and prolonged wound healing. PDL was associated with the lowest risk of side effects, and was as effective as conventional therapies, including cryotherapy and cantharidin.

In Er:YAG treatments, the laser was used for direct ablation of the epidermis on the wart, repeating through layers until normal skin is revealed. Overall, patients treated with Er:YAG demonstrated a higher response and lower recurrence when treated in combination with podofilox. Nd:YAG treatment was similar to PDL, but with a longer wavelength that allows for deeper penetration.

Treatment is limited by a lack of evidence to guide selection of the most appropriate lasers for different warts and by a lack of recommendations for specific laser settings, the researchers noted. Additional studies are needed to establish treatment protocols by comparing lasers to each other and to nonlaser treatments.

However, laser treatment of warts can be “an additional therapeutic option and the studies reviewed here can provide a starting point in determining settings,” they said.

The researchers had no financial disclosures.

Women with dense breasts may benefit from additional screening at the time of digital mammography, but the messages notifying these women of potential risks and benefits of more screening are often poorly written and understood, according to a pair of studies published online in JAMA on April 26.

Adding tomosynthesis to screening digital mammography significantly increased cancer detection rates in women with dense and nondense breasts, based on data from a retrospective study of 452,320 examinations.

©Thinkstock

Dense breast tissue may be an independent risk factor for breast cancer, but the impact of additional treatment modalities on women with dense breasts has not been well studied, wrote Dr. Elizabeth A. Rafferty of L&M Radiology in West Acton, Mass., and associates. Dr. Rafferty conducted the study with colleagues while affiliated with Massachusetts General Hospital in Boston (JAMA 2016 Apr 26. doi: 10.1001/jama.2016.1708).

The researchers reviewed data from an earlier multicenter study involving 13 U.S. institutions, with data reported for 12 months that included 278,906 digital mammographies and 173,414 digital mammographies plus tomosynthesis. A total of 2,157 cancers were diagnosed. Cancer detection rates increased in both groups with the addition of tomosynthesis: Invasive cancer detection increased from 3.0 to 4.0 per 1,000 screens in nondense breasts and from 2.9 to 4.2 per 1,000 screens in dense breasts.

In addition, recall rates decreased from 90 to 79 per 1,000 screens in nondense breasts and from 127 to 109 per 1,000 screens in dense breasts.

Although the study was limited by its retrospective design, the results suggest that the “combined gains were largest for women with heterogeneously dense breasts, potentially addressing limitations in cancer detection seen with digital mammography alone in this group, but were not significant in women with extremely dense breasts,” the researchers noted.

The researchers had no financial conflicts to disclose, and the study was supported by a research grant from Hologic.

Meanwhile, a separate study published in JAMA found that most messages sent to notify women of breast density are poorly understood.

Nancy R. Kressin, Ph.D., of Veterans Affairs Boston Healthcare System and Boston University and colleagues examined the dense breast notifications sent to women following screening mammography in 23 of the 24 states that required such notifications as of January 2016. They assessed the messages for content, readability, and understandability (JAMA 2016 Apr 26. doi: 10.1001/jama.2016.1712).

Although all the notifications reviewed mentioned masking bias (how dense breasts can mask cancer on mammography), the researchers found considerable variation in other content: 74% of notifications mentioned increased cancer risk and 65% mentioned the option of additional screening. Of the 15 states that require supplemental screening to be mentioned, six state notifications explained that the women might benefit from such screening and four state notifications mentioned specific screening modalities.

Only three states’ notifications were written at grade 8 reading level or below, although approximately 20% of the U.S. population reads at grade 5 level or below, the researchers noted. All states’ notifications scored between 11% and 33% on a measure of readability.

“Many [dense breast notifications] appropriately encourage discussions and shared decision making between patients and physicians,” the researchers noted. However, “efforts should focus on enhancing the understandability of [dense breast notifications] so that all women are clearly and accurately informed about their density status, its effect on their breast cancer risk, and the harms and benefits of supplemental screening,” they wrote.

Dr. Kressin reported receiving a Research Career Scientist award from the Department of Veterans Affairs, and coauthor Dr. Tracy Battaglia is the chair elect of the American Cancer Society of New England.

Women with dense breasts may benefit from additional screening at the time of digital mammography, but the messages notifying these women of potential risks and benefits of more screening are often poorly written and understood, according to a pair of studies published online in JAMA on April 26.

Adding tomosynthesis to screening digital mammography significantly increased cancer detection rates in women with dense and nondense breasts, based on data from a retrospective study of 452,320 examinations.

©Thinkstock

Dense breast tissue may be an independent risk factor for breast cancer, but the impact of additional treatment modalities on women with dense breasts has not been well studied, wrote Dr. Elizabeth A. Rafferty of L&M Radiology in West Acton, Mass., and associates. Dr. Rafferty conducted the study with colleagues while affiliated with Massachusetts General Hospital in Boston (JAMA 2016 Apr 26. doi: 10.1001/jama.2016.1708).

The researchers reviewed data from an earlier multicenter study involving 13 U.S. institutions, with data reported for 12 months that included 278,906 digital mammographies and 173,414 digital mammographies plus tomosynthesis. A total of 2,157 cancers were diagnosed. Cancer detection rates increased in both groups with the addition of tomosynthesis: Invasive cancer detection increased from 3.0 to 4.0 per 1,000 screens in nondense breasts and from 2.9 to 4.2 per 1,000 screens in dense breasts.

In addition, recall rates decreased from 90 to 79 per 1,000 screens in nondense breasts and from 127 to 109 per 1,000 screens in dense breasts.

Although the study was limited by its retrospective design, the results suggest that the “combined gains were largest for women with heterogeneously dense breasts, potentially addressing limitations in cancer detection seen with digital mammography alone in this group, but were not significant in women with extremely dense breasts,” the researchers noted.

The researchers had no financial conflicts to disclose, and the study was supported by a research grant from Hologic.

Meanwhile, a separate study published in JAMA found that most messages sent to notify women of breast density are poorly understood.

Nancy R. Kressin, Ph.D., of Veterans Affairs Boston Healthcare System and Boston University and colleagues examined the dense breast notifications sent to women following screening mammography in 23 of the 24 states that required such notifications as of January 2016. They assessed the messages for content, readability, and understandability (JAMA 2016 Apr 26. doi: 10.1001/jama.2016.1712).

Although all the notifications reviewed mentioned masking bias (how dense breasts can mask cancer on mammography), the researchers found considerable variation in other content: 74% of notifications mentioned increased cancer risk and 65% mentioned the option of additional screening. Of the 15 states that require supplemental screening to be mentioned, six state notifications explained that the women might benefit from such screening and four state notifications mentioned specific screening modalities.

Only three states’ notifications were written at grade 8 reading level or below, although approximately 20% of the U.S. population reads at grade 5 level or below, the researchers noted. All states’ notifications scored between 11% and 33% on a measure of readability.

“Many [dense breast notifications] appropriately encourage discussions and shared decision making between patients and physicians,” the researchers noted. However, “efforts should focus on enhancing the understandability of [dense breast notifications] so that all women are clearly and accurately informed about their density status, its effect on their breast cancer risk, and the harms and benefits of supplemental screening,” they wrote.

Dr. Kressin reported receiving a Research Career Scientist award from the Department of Veterans Affairs, and coauthor Dr. Tracy Battaglia is the chair elect of the American Cancer Society of New England.

Women with dense breasts may benefit from additional screening at the time of digital mammography, but the messages notifying these women of potential risks and benefits of more screening are often poorly written and understood, according to a pair of studies published online in JAMA on April 26.

Adding tomosynthesis to screening digital mammography significantly increased cancer detection rates in women with dense and nondense breasts, based on data from a retrospective study of 452,320 examinations.

©Thinkstock

Dense breast tissue may be an independent risk factor for breast cancer, but the impact of additional treatment modalities on women with dense breasts has not been well studied, wrote Dr. Elizabeth A. Rafferty of L&M Radiology in West Acton, Mass., and associates. Dr. Rafferty conducted the study with colleagues while affiliated with Massachusetts General Hospital in Boston (JAMA 2016 Apr 26. doi: 10.1001/jama.2016.1708).

The researchers reviewed data from an earlier multicenter study involving 13 U.S. institutions, with data reported for 12 months that included 278,906 digital mammographies and 173,414 digital mammographies plus tomosynthesis. A total of 2,157 cancers were diagnosed. Cancer detection rates increased in both groups with the addition of tomosynthesis: Invasive cancer detection increased from 3.0 to 4.0 per 1,000 screens in nondense breasts and from 2.9 to 4.2 per 1,000 screens in dense breasts.

In addition, recall rates decreased from 90 to 79 per 1,000 screens in nondense breasts and from 127 to 109 per 1,000 screens in dense breasts.

Although the study was limited by its retrospective design, the results suggest that the “combined gains were largest for women with heterogeneously dense breasts, potentially addressing limitations in cancer detection seen with digital mammography alone in this group, but were not significant in women with extremely dense breasts,” the researchers noted.

The researchers had no financial conflicts to disclose, and the study was supported by a research grant from Hologic.

Meanwhile, a separate study published in JAMA found that most messages sent to notify women of breast density are poorly understood.

Nancy R. Kressin, Ph.D., of Veterans Affairs Boston Healthcare System and Boston University and colleagues examined the dense breast notifications sent to women following screening mammography in 23 of the 24 states that required such notifications as of January 2016. They assessed the messages for content, readability, and understandability (JAMA 2016 Apr 26. doi: 10.1001/jama.2016.1712).

Although all the notifications reviewed mentioned masking bias (how dense breasts can mask cancer on mammography), the researchers found considerable variation in other content: 74% of notifications mentioned increased cancer risk and 65% mentioned the option of additional screening. Of the 15 states that require supplemental screening to be mentioned, six state notifications explained that the women might benefit from such screening and four state notifications mentioned specific screening modalities.

Only three states’ notifications were written at grade 8 reading level or below, although approximately 20% of the U.S. population reads at grade 5 level or below, the researchers noted. All states’ notifications scored between 11% and 33% on a measure of readability.

“Many [dense breast notifications] appropriately encourage discussions and shared decision making between patients and physicians,” the researchers noted. However, “efforts should focus on enhancing the understandability of [dense breast notifications] so that all women are clearly and accurately informed about their density status, its effect on their breast cancer risk, and the harms and benefits of supplemental screening,” they wrote.

Dr. Kressin reported receiving a Research Career Scientist award from the Department of Veterans Affairs, and coauthor Dr. Tracy Battaglia is the chair elect of the American Cancer Society of New England.

Ustekinumab induced a clinical response and remission in adults with moderate to severe Crohn’s disease who had failed or failed to tolerate other anti–tumor necrosis factor therapies in a phase III induction study of 741 patients (UNITI-1).

The findings were presented at the European Crohn’s and Colitis Organization (ECCO) conference in Amsterdam.

“There is great need for improved therapy for Crohn’s disease, since many patients are failing conventional therapies and also TNF [tumor necrosis factor] antagonists,” lead author Dr. Paul Rutgeerts said in an interview. “Blockade of IL-12/23 is a new mode of action in IBD [inflammatory bowel disease], although this therapy has already been proven effective in the treatment of psoriasis and psoriatic arthropathy,” he said. Data from prior large-scale studies show that ustekinumab is effective in patients with refractory Crohn’s disease, noted Dr. Rutgeerts of University Hospital Gasthuisberg, in Leuven, the Netherlands.

Ustekinumab is approved for treating moderate to severe plaque psoriasis and psoriatic arthritis, and was tested in a phase IIb study for Crohn’s disease in which intravenous ustekinumab induction was followed by surveillance colonoscopy maintenance. This study reviewed the safety and efficacy of intravenous ustekinumab in the same patient population.

The patients were randomized to a 130-mg dose of ustekinumab, weight-based dosing of ustekinumab at 6 mg/kg, or an intravenous placebo. The patients had an average disease duration of 10 years, a baseline median Crohn’s Disease Activity Index (CDAI) score of 317, and a baseline C-reactive protein level of 9.9 mg/L.

After 6 weeks, 34% of patients treated with 6 mg/kg or 130 mg of ustekinumab showed a clinical response, vs. 22% of placebo patients. Clinical response was defined as a reduction from baseline of the CDAI score of at least 100 points. At 8 weeks, patients entered an ongoing maintenance study or were followed up to 20 weeks. Clinical remission (defined as a CDAI score of less than 150 points) at 8 weeks was significantly higher in the 6-mg/kg group (21%) and 130-mg group (16%), compared with the placebo group (7%).

In addition, patients in both ustekinumab groups showed significant improvements in C-reactive protein (CRP), fecal lactoferrin, and calprotectin, and in scores on the Inflammatory Bowel Disease Questionnaire, compared with placebo patients.

The incidence of adverse events, serious adverse events, and infections was not significantly different among the treatment and placebo groups, and no deaths, malignancies, or major adverse events were reported among ustekinumab patients through the 20-week follow-up period.

“The clinical and biologic efficacy of the drug is robust both in patients who have failed conventional drugs and patients who have already failed one, two, or three anti-TNF biologicals,” Dr. Rutgeerts noted. “The approval of Stelara for Crohn’s disease would represent a new treatment option for the more than 5 million people worldwide, including nearly 700,000 Americans, who are living with an inflammatory bowel disease,” he said.

Data from the ongoing IM-UNITI study will demonstrate the long-term efficacy of ustekinumab for Crohn’s patients, but another key step for research would be a head-to-head comparison between ustekinumab and an anti-TNF antibody, Dr. Rutgeerts added.

Dr. Rutgeerts disclosed receiving personal fees from multiple companies including Johnson & Johnson, Amgen, AstraZeneca, Medimmune, Merck, and UCB. The study was supported in part by Janssen.

Ustekinumab induced a clinical response and remission in adults with moderate to severe Crohn’s disease who had failed or failed to tolerate other anti–tumor necrosis factor therapies in a phase III induction study of 741 patients (UNITI-1).

The findings were presented at the European Crohn’s and Colitis Organization (ECCO) conference in Amsterdam.

“There is great need for improved therapy for Crohn’s disease, since many patients are failing conventional therapies and also TNF [tumor necrosis factor] antagonists,” lead author Dr. Paul Rutgeerts said in an interview. “Blockade of IL-12/23 is a new mode of action in IBD [inflammatory bowel disease], although this therapy has already been proven effective in the treatment of psoriasis and psoriatic arthropathy,” he said. Data from prior large-scale studies show that ustekinumab is effective in patients with refractory Crohn’s disease, noted Dr. Rutgeerts of University Hospital Gasthuisberg, in Leuven, the Netherlands.

Ustekinumab is approved for treating moderate to severe plaque psoriasis and psoriatic arthritis, and was tested in a phase IIb study for Crohn’s disease in which intravenous ustekinumab induction was followed by surveillance colonoscopy maintenance. This study reviewed the safety and efficacy of intravenous ustekinumab in the same patient population.

The patients were randomized to a 130-mg dose of ustekinumab, weight-based dosing of ustekinumab at 6 mg/kg, or an intravenous placebo. The patients had an average disease duration of 10 years, a baseline median Crohn’s Disease Activity Index (CDAI) score of 317, and a baseline C-reactive protein level of 9.9 mg/L.

After 6 weeks, 34% of patients treated with 6 mg/kg or 130 mg of ustekinumab showed a clinical response, vs. 22% of placebo patients. Clinical response was defined as a reduction from baseline of the CDAI score of at least 100 points. At 8 weeks, patients entered an ongoing maintenance study or were followed up to 20 weeks. Clinical remission (defined as a CDAI score of less than 150 points) at 8 weeks was significantly higher in the 6-mg/kg group (21%) and 130-mg group (16%), compared with the placebo group (7%).

In addition, patients in both ustekinumab groups showed significant improvements in C-reactive protein (CRP), fecal lactoferrin, and calprotectin, and in scores on the Inflammatory Bowel Disease Questionnaire, compared with placebo patients.

The incidence of adverse events, serious adverse events, and infections was not significantly different among the treatment and placebo groups, and no deaths, malignancies, or major adverse events were reported among ustekinumab patients through the 20-week follow-up period.

“The clinical and biologic efficacy of the drug is robust both in patients who have failed conventional drugs and patients who have already failed one, two, or three anti-TNF biologicals,” Dr. Rutgeerts noted. “The approval of Stelara for Crohn’s disease would represent a new treatment option for the more than 5 million people worldwide, including nearly 700,000 Americans, who are living with an inflammatory bowel disease,” he said.

Data from the ongoing IM-UNITI study will demonstrate the long-term efficacy of ustekinumab for Crohn’s patients, but another key step for research would be a head-to-head comparison between ustekinumab and an anti-TNF antibody, Dr. Rutgeerts added.

Dr. Rutgeerts disclosed receiving personal fees from multiple companies including Johnson & Johnson, Amgen, AstraZeneca, Medimmune, Merck, and UCB. The study was supported in part by Janssen.

Ustekinumab induced a clinical response and remission in adults with moderate to severe Crohn’s disease who had failed or failed to tolerate other anti–tumor necrosis factor therapies in a phase III induction study of 741 patients (UNITI-1).

The findings were presented at the European Crohn’s and Colitis Organization (ECCO) conference in Amsterdam.

“There is great need for improved therapy for Crohn’s disease, since many patients are failing conventional therapies and also TNF [tumor necrosis factor] antagonists,” lead author Dr. Paul Rutgeerts said in an interview. “Blockade of IL-12/23 is a new mode of action in IBD [inflammatory bowel disease], although this therapy has already been proven effective in the treatment of psoriasis and psoriatic arthropathy,” he said. Data from prior large-scale studies show that ustekinumab is effective in patients with refractory Crohn’s disease, noted Dr. Rutgeerts of University Hospital Gasthuisberg, in Leuven, the Netherlands.

Ustekinumab is approved for treating moderate to severe plaque psoriasis and psoriatic arthritis, and was tested in a phase IIb study for Crohn’s disease in which intravenous ustekinumab induction was followed by surveillance colonoscopy maintenance. This study reviewed the safety and efficacy of intravenous ustekinumab in the same patient population.

The patients were randomized to a 130-mg dose of ustekinumab, weight-based dosing of ustekinumab at 6 mg/kg, or an intravenous placebo. The patients had an average disease duration of 10 years, a baseline median Crohn’s Disease Activity Index (CDAI) score of 317, and a baseline C-reactive protein level of 9.9 mg/L.

After 6 weeks, 34% of patients treated with 6 mg/kg or 130 mg of ustekinumab showed a clinical response, vs. 22% of placebo patients. Clinical response was defined as a reduction from baseline of the CDAI score of at least 100 points. At 8 weeks, patients entered an ongoing maintenance study or were followed up to 20 weeks. Clinical remission (defined as a CDAI score of less than 150 points) at 8 weeks was significantly higher in the 6-mg/kg group (21%) and 130-mg group (16%), compared with the placebo group (7%).

In addition, patients in both ustekinumab groups showed significant improvements in C-reactive protein (CRP), fecal lactoferrin, and calprotectin, and in scores on the Inflammatory Bowel Disease Questionnaire, compared with placebo patients.

The incidence of adverse events, serious adverse events, and infections was not significantly different among the treatment and placebo groups, and no deaths, malignancies, or major adverse events were reported among ustekinumab patients through the 20-week follow-up period.

“The clinical and biologic efficacy of the drug is robust both in patients who have failed conventional drugs and patients who have already failed one, two, or three anti-TNF biologicals,” Dr. Rutgeerts noted. “The approval of Stelara for Crohn’s disease would represent a new treatment option for the more than 5 million people worldwide, including nearly 700,000 Americans, who are living with an inflammatory bowel disease,” he said.

Data from the ongoing IM-UNITI study will demonstrate the long-term efficacy of ustekinumab for Crohn’s patients, but another key step for research would be a head-to-head comparison between ustekinumab and an anti-TNF antibody, Dr. Rutgeerts added.

Dr. Rutgeerts disclosed receiving personal fees from multiple companies including Johnson & Johnson, Amgen, AstraZeneca, Medimmune, Merck, and UCB. The study was supported in part by Janssen.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

BOSTON – Many developers of innovative medical technologies don’t realize that insurers are going to want to see evidence that a new technology improves health outcomes before they will consider paying for it, according to Dr. Louis Jacques, senior vice president and chief clinical officer for ADVI, a health care advisory services firm in Washington.

The Centers for Medicare & Medicaid Services generally seeks “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population” when determining Medicare coverage, Dr. Jacques said in a presentation at the 2016 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Medicare is less likely to pay if there is something controversial about the available evidence, he said in an interview. “The controversy is usually about inadequate evidence or lack of applicability to the affected Medicare beneficiary population,” Dr. Jacques said, noting that the typical Medicare patient, a 74-year-old woman with comorbid conditions taking multiple medications, often is not the type of person included in clinical trials that would generate such evidence.

Medicare is looking for “adequate evidence that a treatment strategy using the new therapeutic technology, compared to alternatives, leads to improved clinically meaningful health outcomes in Medicare beneficiaries,” he said.

Similarly, new diagnostic technologies should provide the physician with additional information that can alter treatment recommendations, resulting in therapeutic changes that improve outcomes.

Dr. Jacques noted that over the next several years, the health care system will move away from fee for service and begin more and more to pay for value, with physicians becoming more accountable for outcomes and cost.

He advised those developing a new device or treatment to think about how they would justify a particular treatment approach to their colleagues. They need to ask themselves: “What is the value proposition that supports what they are recommending? Are they choosing it because it has better outcomes, is less likely to have an adverse event, is more efficiently provided, or is it something that is less expensive?” he said.

Two major health reform laws will change how insurers pay for new medical devices, though the impact of these changes remains to be seen. According to Harry Glorikian, a health care consultant based in Lexington, Mass., the Affordable Care Act and the Medicaid and CHIP Reauthorization Act (MACRA) put many items into play, most notably fundamental changes in Medicare/Medicaid and the shift from fee-for-service to value-based payment.

“It’s a crazy time because of the need for virtually all hospital-based organizations to operate under both fee-for-service and non–fee-for-service payment arrangements right now,” he said in an interview.

Along with those two reform laws, the Health & Human Services department has set a schedule for transitioning to paying for the value – rather than the volume – of care. The initial goal – 30% of Medicare payments based on value by the end of 2016 – was reached in early March.

“HHS also set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018 through programs such as the Hospital Value-Based Purchasing and the Hospital Readmissions Reduction programs. This will be huge, and its impact will be tremendous,” he added.

One tool physicians can leverage to show value in this new payment landscape is the AGA Digestive Health Recognition Program, a quality improvement program and clinical data registry that allows clinicians to demonstrate quality of care for several disease states (colorectal cancer, hepatitis C virus, and irritable bowel disease) (www.gastro.org/DHRP).

Over the next 5-10 years, watch for changes in value-based payment models and a long-term move to a single-payer system, said Mr. Glorikian. In addition, expect changes in the workforce in terms of who delivers care and how.

Finally, physicians will need to use big data to manage patients, prescribe therapy, and integrate all aspects of medical practice, he said.

Dr. Jacques disclosed that he has financial relationships with Exact Sciences and Medtronic.

Here are 4 articles in the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Later Menopause Lowers Risk for Later Depression
To take the posttest, go to: http://bit.ly/1U7I7f3
Expires January 6, 2017

VITALS
Key clinical point: Later menopause, with its longer estrogen exposure, appears tied to a lower risk of postmenopausal depression.
Major finding: The risk of depression decreased by 2% for each 2 premenopausal years after age 40.
Data source: The meta-analysis comprised 14 studies with more than 67,700 women.
Disclosures: Neither Dr. Georgakis nor any of the coauthors declared any financial conflicts.

2. Preschool ASD Prevalence Estimates Lower Than Grade School Estimates
To take the posttest, go to: http://bit.ly/24Mec0X
Expires January 5, 2017

VITALS
Key clinical point: The prevalence of autism spectrum disorders among 4-year-olds is about 30% lower than among 8-year-olds.
Major finding: Prevalence of ASD among 4-year-olds was 13/1,000 children across five U.S. states.
Data source: A comparison of health and medical records for nationally representative cohorts involving 58,467 4-year-olds and 56,727 8-year-olds in five U.S. states in 2010.
Disclosures: The Centers for Disease Control and Prevention funded the research. Dr. Christensen and her associates reported no disclosures.

3. Long-term PPI Use Linked to Increased Risk for Dementia
To take the posttest, go to: http://bit.ly/1nrCdsb
Expires February 24, 2017

VITALS
Key clinical point: Proton pump inhibitors may add to the risk of dementia in older adults. 
Major finding: The risk of incident dementia was 44% higher in adults who used PPIs long term, compared with those who did not. 
Data source: The prospective cohort study included 73,679 adults aged 75 years and older.
Disclosures: The researchers had no financial conflicts to disclose.

4. Elevated Cardiovascular Risks Linked to Hidradenitis Suppurativa
To take the posttest, go to: http://bit.ly/1nrEFz3
Expires February 17, 2017

VITALS
Key clinical point: Hidradenitis suppurativa is associated with a significantly increased risk of adverse cardiovascular events and all-cause mortality.
Major finding: Individuals with hidradenitis suppurativa had a 57% greater risk of myocardial infarction and 33% greater risk of ischemic stroke, compared with the general population. 
Data source: A population-based cohort study in 5,964 patients with hidradenitis suppurativa.
Disclosures: No conflicts of interest were declared.

Here are 4 articles in the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Later Menopause Lowers Risk for Later Depression
To take the posttest, go to: http://bit.ly/1U7I7f3
Expires January 6, 2017

VITALS
Key clinical point: Later menopause, with its longer estrogen exposure, appears tied to a lower risk of postmenopausal depression.
Major finding: The risk of depression decreased by 2% for each 2 premenopausal years after age 40.
Data source: The meta-analysis comprised 14 studies with more than 67,700 women.
Disclosures: Neither Dr. Georgakis nor any of the coauthors declared any financial conflicts.

2. Preschool ASD Prevalence Estimates Lower Than Grade School Estimates
To take the posttest, go to: http://bit.ly/24Mec0X
Expires January 5, 2017

VITALS
Key clinical point: The prevalence of autism spectrum disorders among 4-year-olds is about 30% lower than among 8-year-olds.
Major finding: Prevalence of ASD among 4-year-olds was 13/1,000 children across five U.S. states.
Data source: A comparison of health and medical records for nationally representative cohorts involving 58,467 4-year-olds and 56,727 8-year-olds in five U.S. states in 2010.
Disclosures: The Centers for Disease Control and Prevention funded the research. Dr. Christensen and her associates reported no disclosures.

3. Long-term PPI Use Linked to Increased Risk for Dementia
To take the posttest, go to: http://bit.ly/1nrCdsb
Expires February 24, 2017

VITALS
Key clinical point: Proton pump inhibitors may add to the risk of dementia in older adults. 
Major finding: The risk of incident dementia was 44% higher in adults who used PPIs long term, compared with those who did not. 
Data source: The prospective cohort study included 73,679 adults aged 75 years and older.
Disclosures: The researchers had no financial conflicts to disclose.

4. Elevated Cardiovascular Risks Linked to Hidradenitis Suppurativa
To take the posttest, go to: http://bit.ly/1nrEFz3
Expires February 17, 2017

VITALS
Key clinical point: Hidradenitis suppurativa is associated with a significantly increased risk of adverse cardiovascular events and all-cause mortality.
Major finding: Individuals with hidradenitis suppurativa had a 57% greater risk of myocardial infarction and 33% greater risk of ischemic stroke, compared with the general population. 
Data source: A population-based cohort study in 5,964 patients with hidradenitis suppurativa.
Disclosures: No conflicts of interest were declared.

Here are 4 articles in the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Later Menopause Lowers Risk for Later Depression
To take the posttest, go to: http://bit.ly/1U7I7f3
Expires January 6, 2017

VITALS
Key clinical point: Later menopause, with its longer estrogen exposure, appears tied to a lower risk of postmenopausal depression.
Major finding: The risk of depression decreased by 2% for each 2 premenopausal years after age 40.
Data source: The meta-analysis comprised 14 studies with more than 67,700 women.
Disclosures: Neither Dr. Georgakis nor any of the coauthors declared any financial conflicts.

2. Preschool ASD Prevalence Estimates Lower Than Grade School Estimates
To take the posttest, go to: http://bit.ly/24Mec0X
Expires January 5, 2017

VITALS
Key clinical point: The prevalence of autism spectrum disorders among 4-year-olds is about 30% lower than among 8-year-olds.
Major finding: Prevalence of ASD among 4-year-olds was 13/1,000 children across five U.S. states.
Data source: A comparison of health and medical records for nationally representative cohorts involving 58,467 4-year-olds and 56,727 8-year-olds in five U.S. states in 2010.
Disclosures: The Centers for Disease Control and Prevention funded the research. Dr. Christensen and her associates reported no disclosures.

3. Long-term PPI Use Linked to Increased Risk for Dementia
To take the posttest, go to: http://bit.ly/1nrCdsb
Expires February 24, 2017

VITALS
Key clinical point: Proton pump inhibitors may add to the risk of dementia in older adults. 
Major finding: The risk of incident dementia was 44% higher in adults who used PPIs long term, compared with those who did not. 
Data source: The prospective cohort study included 73,679 adults aged 75 years and older.
Disclosures: The researchers had no financial conflicts to disclose.

4. Elevated Cardiovascular Risks Linked to Hidradenitis Suppurativa
To take the posttest, go to: http://bit.ly/1nrEFz3
Expires February 17, 2017

VITALS
Key clinical point: Hidradenitis suppurativa is associated with a significantly increased risk of adverse cardiovascular events and all-cause mortality.
Major finding: Individuals with hidradenitis suppurativa had a 57% greater risk of myocardial infarction and 33% greater risk of ischemic stroke, compared with the general population. 
Data source: A population-based cohort study in 5,964 patients with hidradenitis suppurativa.
Disclosures: No conflicts of interest were declared.

Individuals with rosacea were nearly twice as likely to develop Parkinson’s disease as those without rosacea, based on an analysis of results of a nationwide cohort study of 5.4 million people conducted in Denmark. The findings were published online March 21 in JAMA Neurology.

Data from previous studies suggest a link between rosacea and Parkinson’s disease (PD), as both may stem from elevated activity of matrix metalloproteinases, wrote Dr. Alexander Egeberg of the University of Copenhagen, and his associates.

M. Sand, et al/Head & face medicine/ISSN 1746-160X/CC BY 2.0

To explore the possible link between rosacea and Parkinson’s disease, the researchers reviewed data on about 5.4 million adults in a Danish database of all citizens aged 18 and older, over a 15-year period from January 1, 1997, to December 31, 2011. A total of 22,387 individuals were diagnosed with Parkinson’s disease and 68,053 were diagnosed with rosacea (JAMA Neurol. 2016 Mar 21. doi: 10.1001/jamaneurol.2016.0022).

The incidence of Parkinson’s disease was 7.62 per 10,000 person-years among rosacea patients vs. 3.54 per 10,000 person-years in the general population, the researchers noted.

Overall, the Parkinson’s disease risk was significantly higher among rosacea patients, with an adjusted incidence rate ratio (IRR) of 1.71 for rosacea patients compared with the general population. The IRR was even higher in patients with ocular rosacea (adjusted IRR, 2.03).

However, treatment with tetracycline appeared to reduce the Parkinson’s risk in the rosacea patients: After controlling for multiple variables, having filled a prescription for tetracycline was associated with a 2% drop in the risk of PD (adjusted IRR, 0.98).

A sensitivity analysis showed no dose-dependent relationship with disease severity; the IRRs for Parkinson’s disease in patients with mild rosacea and moderate to severe rosacea were 1.82 and 1.84, respectively. However, moderate to severe rosacea was defined as cases where tetracyclines were used, and the neuroprotective effect of tetracyclines might impact the relationship between rosacea and Parkinson’s disease, the researchers noted.

“It is tempting to speculate that, in patients with coexistent rosacea, Parkinson’s disease may display other phenotypic characteristics, and it is possible that rosacea-associated features, such as facial flushing, may contribute to support a Parkinson’s disease diagnosis at an early phase of the disease,” the researchers noted.

Limitations of the study include its observational design, which does not allow the establishment of causation, the researchers noted, and additional research is needed to confirm the observations and clinical consequences.

Lead author Dr. Egeberg was employed by Pfizer at the time of the study; one of the coauthors was supported by an unrestricted research scholarship from the Novo Nordisk Foundation.

Individuals with rosacea were nearly twice as likely to develop Parkinson’s disease as those without rosacea, based on an analysis of results of a nationwide cohort study of 5.4 million people conducted in Denmark. The findings were published online March 21 in JAMA Neurology.

Data from previous studies suggest a link between rosacea and Parkinson’s disease (PD), as both may stem from elevated activity of matrix metalloproteinases, wrote Dr. Alexander Egeberg of the University of Copenhagen, and his associates.

M. Sand, et al/Head & face medicine/ISSN 1746-160X/CC BY 2.0

To explore the possible link between rosacea and Parkinson’s disease, the researchers reviewed data on about 5.4 million adults in a Danish database of all citizens aged 18 and older, over a 15-year period from January 1, 1997, to December 31, 2011. A total of 22,387 individuals were diagnosed with Parkinson’s disease and 68,053 were diagnosed with rosacea (JAMA Neurol. 2016 Mar 21. doi: 10.1001/jamaneurol.2016.0022).

The incidence of Parkinson’s disease was 7.62 per 10,000 person-years among rosacea patients vs. 3.54 per 10,000 person-years in the general population, the researchers noted.

Overall, the Parkinson’s disease risk was significantly higher among rosacea patients, with an adjusted incidence rate ratio (IRR) of 1.71 for rosacea patients compared with the general population. The IRR was even higher in patients with ocular rosacea (adjusted IRR, 2.03).

However, treatment with tetracycline appeared to reduce the Parkinson’s risk in the rosacea patients: After controlling for multiple variables, having filled a prescription for tetracycline was associated with a 2% drop in the risk of PD (adjusted IRR, 0.98).

A sensitivity analysis showed no dose-dependent relationship with disease severity; the IRRs for Parkinson’s disease in patients with mild rosacea and moderate to severe rosacea were 1.82 and 1.84, respectively. However, moderate to severe rosacea was defined as cases where tetracyclines were used, and the neuroprotective effect of tetracyclines might impact the relationship between rosacea and Parkinson’s disease, the researchers noted.

“It is tempting to speculate that, in patients with coexistent rosacea, Parkinson’s disease may display other phenotypic characteristics, and it is possible that rosacea-associated features, such as facial flushing, may contribute to support a Parkinson’s disease diagnosis at an early phase of the disease,” the researchers noted.

Limitations of the study include its observational design, which does not allow the establishment of causation, the researchers noted, and additional research is needed to confirm the observations and clinical consequences.

Lead author Dr. Egeberg was employed by Pfizer at the time of the study; one of the coauthors was supported by an unrestricted research scholarship from the Novo Nordisk Foundation.

Individuals with rosacea were nearly twice as likely to develop Parkinson’s disease as those without rosacea, based on an analysis of results of a nationwide cohort study of 5.4 million people conducted in Denmark. The findings were published online March 21 in JAMA Neurology.

Data from previous studies suggest a link between rosacea and Parkinson’s disease (PD), as both may stem from elevated activity of matrix metalloproteinases, wrote Dr. Alexander Egeberg of the University of Copenhagen, and his associates.

M. Sand, et al/Head & face medicine/ISSN 1746-160X/CC BY 2.0

To explore the possible link between rosacea and Parkinson’s disease, the researchers reviewed data on about 5.4 million adults in a Danish database of all citizens aged 18 and older, over a 15-year period from January 1, 1997, to December 31, 2011. A total of 22,387 individuals were diagnosed with Parkinson’s disease and 68,053 were diagnosed with rosacea (JAMA Neurol. 2016 Mar 21. doi: 10.1001/jamaneurol.2016.0022).

The incidence of Parkinson’s disease was 7.62 per 10,000 person-years among rosacea patients vs. 3.54 per 10,000 person-years in the general population, the researchers noted.

Overall, the Parkinson’s disease risk was significantly higher among rosacea patients, with an adjusted incidence rate ratio (IRR) of 1.71 for rosacea patients compared with the general population. The IRR was even higher in patients with ocular rosacea (adjusted IRR, 2.03).

However, treatment with tetracycline appeared to reduce the Parkinson’s risk in the rosacea patients: After controlling for multiple variables, having filled a prescription for tetracycline was associated with a 2% drop in the risk of PD (adjusted IRR, 0.98).

A sensitivity analysis showed no dose-dependent relationship with disease severity; the IRRs for Parkinson’s disease in patients with mild rosacea and moderate to severe rosacea were 1.82 and 1.84, respectively. However, moderate to severe rosacea was defined as cases where tetracyclines were used, and the neuroprotective effect of tetracyclines might impact the relationship between rosacea and Parkinson’s disease, the researchers noted.

“It is tempting to speculate that, in patients with coexistent rosacea, Parkinson’s disease may display other phenotypic characteristics, and it is possible that rosacea-associated features, such as facial flushing, may contribute to support a Parkinson’s disease diagnosis at an early phase of the disease,” the researchers noted.

Limitations of the study include its observational design, which does not allow the establishment of causation, the researchers noted, and additional research is needed to confirm the observations and clinical consequences.

Lead author Dr. Egeberg was employed by Pfizer at the time of the study; one of the coauthors was supported by an unrestricted research scholarship from the Novo Nordisk Foundation.