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Navigating the complex landscape of IBD therapies
I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week® 2017.
In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).
Ustekinumab is a monoclonal antibody to interleukins 12 and 23, and was approved for moderate to severe CD last year on the basis of the pivotal UNITI-1, UNITI-2, and IM-UNITI trials (N Engl J Med. 2016;375:1946-60). A weight-based intravenous loading dose was shown to be effective at inducing clinical response in both patients who had failed or were intolerant to anti-TNF therapy and those who had not. The responders in both induction trials were randomized to two subcutaneous doses of ustekinumab or placebo, and at the end of the 44-week trial, the drug met multiple efficacy endpoints, including clinical remission, clinical response, steroid-free remission, and sustained clinical remission. In another abstract, the rate of tuberculosis reactivation within the clinical development program of ustekinumab across all indications (6,581 patients, over 12,000 patient-years of follow-up) was significantly lower at 0.02 cases per 100 patient-years compared with the rates seen in the golimumab (0.24 per 100) and infliximab (0.39 per 100) development programs (Gastroenterology 2017;152[5 Suppl 1]:S596), illustrating that the safety profile of ustekinumab may be significantly different from that of anti-TNF agents.
Tofacitinib, which inhibits mainly JAK1 and JAK3 receptors, is an emergent oral small molecule drug for UC. Three phase 3 randomized placebo-controlled trials (OCTAVE-1, OCTAVE-2, and OCTAVE Sustain) of tofacitinib treatment in moderately to severely active UC patients have been recently published (N Engl J Med. 2017;376:1723-36). The rates of clinical remission at week 8 were significantly greater in patients who were treated with 10 mg tofacitinib than placebo in both induction trials, and results were similar regardless of anti-TNF exposure status. Clinical responders in the induction studies were randomized to placebo or two doses of tofacitinib. At week 52, remission rates were significantly higher in the patients treated with 10 mg tofacitinib twice daily and 5 mg tofacitinib twice daily than those receiving placebo. The percentages of tofacitinib-treated patients who achieved mucosal healing were significantly greater than those in the placebo group. Serious infections occurred significantly more frequently in the tofacitinib than placebo group during induction, but not during maintenance. However, rates of herpes zoster were higher with maintenance therapy at 10 mg twice daily (5.1%) than with placebo (0.5%). A recently published phase 2 study of filgotinib, a selective JAK1 inhibitor, reported that the remission rate at week 10 was significantly higher in active CD patients receiving 200 mg of filgotinib daily than in those receiving placebo (Lancet 2017;389:266-75). A phase 2 trial of another selective JAK1 inhibitor, upadacitinib (ABT-494), for induction therapy in CD patients with a history of failure or intolerance to TNF-antagonists, was presented at DDW (Gastroenterology 2017;152[5 Suppl 1]:S1308-9). Higher rates of clinical remission at week 16 were seen in patients on 6 mg upadacitinib twice daily than placebo, and several doses of upadacitinib were significantly better than placebo for inducing endoscopic remission at week 12 or 16. Serious adverse events were seen in 9%-15% of CD patients treated with these two agents (vs. 4%-5% in placebo-treated patients).
Smad7 regulates the signaling of transforming growth factor (TGF)-beta1, an anti-inflammatory cytokine. Mongersen is an orally delivered anti-sense oligonucleotide that inhibits Smad7 and restores TGF-beta1 signaling, and is being developed for CD. The efficacy of induction therapy for active CD patients with limited active disease (terminal ileum or proximal colon) was demonstrated in a phase 2 study (N Engl J Med. 2015;372:1104-13). Interestingly, this study showed significantly higher rates of clinical remission at day 15 with mongersen. However, there were no endoscopic data available in this trial, baseline serum C-reactive protein concentrations were low, and did not decrease significantly. This drug appears to be well tolerated, and serious adverse events were not significantly higher than for placebo. In a phase 1b study, correlations between clinical and endoscopic outcomes were explored, and among 52 CD patients, SES-CD reductions of at least 25% at week 12 were seen in 37% of mongersen-treated patients (Gastroenterology. 2017;152[5 Suppl 1]:S198).
In summary, the future of IBD medical therapy is bright due to the recent introduction of therapies with novel mechanisms of action and favorable safety profiles (e.g., vedolizumab and ustekinumab), potentially lower-cost biosimilars, and multiple compounds in the drug development pipeline.
Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.
I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week® 2017.
In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).
Ustekinumab is a monoclonal antibody to interleukins 12 and 23, and was approved for moderate to severe CD last year on the basis of the pivotal UNITI-1, UNITI-2, and IM-UNITI trials (N Engl J Med. 2016;375:1946-60). A weight-based intravenous loading dose was shown to be effective at inducing clinical response in both patients who had failed or were intolerant to anti-TNF therapy and those who had not. The responders in both induction trials were randomized to two subcutaneous doses of ustekinumab or placebo, and at the end of the 44-week trial, the drug met multiple efficacy endpoints, including clinical remission, clinical response, steroid-free remission, and sustained clinical remission. In another abstract, the rate of tuberculosis reactivation within the clinical development program of ustekinumab across all indications (6,581 patients, over 12,000 patient-years of follow-up) was significantly lower at 0.02 cases per 100 patient-years compared with the rates seen in the golimumab (0.24 per 100) and infliximab (0.39 per 100) development programs (Gastroenterology 2017;152[5 Suppl 1]:S596), illustrating that the safety profile of ustekinumab may be significantly different from that of anti-TNF agents.
Tofacitinib, which inhibits mainly JAK1 and JAK3 receptors, is an emergent oral small molecule drug for UC. Three phase 3 randomized placebo-controlled trials (OCTAVE-1, OCTAVE-2, and OCTAVE Sustain) of tofacitinib treatment in moderately to severely active UC patients have been recently published (N Engl J Med. 2017;376:1723-36). The rates of clinical remission at week 8 were significantly greater in patients who were treated with 10 mg tofacitinib than placebo in both induction trials, and results were similar regardless of anti-TNF exposure status. Clinical responders in the induction studies were randomized to placebo or two doses of tofacitinib. At week 52, remission rates were significantly higher in the patients treated with 10 mg tofacitinib twice daily and 5 mg tofacitinib twice daily than those receiving placebo. The percentages of tofacitinib-treated patients who achieved mucosal healing were significantly greater than those in the placebo group. Serious infections occurred significantly more frequently in the tofacitinib than placebo group during induction, but not during maintenance. However, rates of herpes zoster were higher with maintenance therapy at 10 mg twice daily (5.1%) than with placebo (0.5%). A recently published phase 2 study of filgotinib, a selective JAK1 inhibitor, reported that the remission rate at week 10 was significantly higher in active CD patients receiving 200 mg of filgotinib daily than in those receiving placebo (Lancet 2017;389:266-75). A phase 2 trial of another selective JAK1 inhibitor, upadacitinib (ABT-494), for induction therapy in CD patients with a history of failure or intolerance to TNF-antagonists, was presented at DDW (Gastroenterology 2017;152[5 Suppl 1]:S1308-9). Higher rates of clinical remission at week 16 were seen in patients on 6 mg upadacitinib twice daily than placebo, and several doses of upadacitinib were significantly better than placebo for inducing endoscopic remission at week 12 or 16. Serious adverse events were seen in 9%-15% of CD patients treated with these two agents (vs. 4%-5% in placebo-treated patients).
Smad7 regulates the signaling of transforming growth factor (TGF)-beta1, an anti-inflammatory cytokine. Mongersen is an orally delivered anti-sense oligonucleotide that inhibits Smad7 and restores TGF-beta1 signaling, and is being developed for CD. The efficacy of induction therapy for active CD patients with limited active disease (terminal ileum or proximal colon) was demonstrated in a phase 2 study (N Engl J Med. 2015;372:1104-13). Interestingly, this study showed significantly higher rates of clinical remission at day 15 with mongersen. However, there were no endoscopic data available in this trial, baseline serum C-reactive protein concentrations were low, and did not decrease significantly. This drug appears to be well tolerated, and serious adverse events were not significantly higher than for placebo. In a phase 1b study, correlations between clinical and endoscopic outcomes were explored, and among 52 CD patients, SES-CD reductions of at least 25% at week 12 were seen in 37% of mongersen-treated patients (Gastroenterology. 2017;152[5 Suppl 1]:S198).
In summary, the future of IBD medical therapy is bright due to the recent introduction of therapies with novel mechanisms of action and favorable safety profiles (e.g., vedolizumab and ustekinumab), potentially lower-cost biosimilars, and multiple compounds in the drug development pipeline.
Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.
I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week® 2017.
In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).
Ustekinumab is a monoclonal antibody to interleukins 12 and 23, and was approved for moderate to severe CD last year on the basis of the pivotal UNITI-1, UNITI-2, and IM-UNITI trials (N Engl J Med. 2016;375:1946-60). A weight-based intravenous loading dose was shown to be effective at inducing clinical response in both patients who had failed or were intolerant to anti-TNF therapy and those who had not. The responders in both induction trials were randomized to two subcutaneous doses of ustekinumab or placebo, and at the end of the 44-week trial, the drug met multiple efficacy endpoints, including clinical remission, clinical response, steroid-free remission, and sustained clinical remission. In another abstract, the rate of tuberculosis reactivation within the clinical development program of ustekinumab across all indications (6,581 patients, over 12,000 patient-years of follow-up) was significantly lower at 0.02 cases per 100 patient-years compared with the rates seen in the golimumab (0.24 per 100) and infliximab (0.39 per 100) development programs (Gastroenterology 2017;152[5 Suppl 1]:S596), illustrating that the safety profile of ustekinumab may be significantly different from that of anti-TNF agents.
Tofacitinib, which inhibits mainly JAK1 and JAK3 receptors, is an emergent oral small molecule drug for UC. Three phase 3 randomized placebo-controlled trials (OCTAVE-1, OCTAVE-2, and OCTAVE Sustain) of tofacitinib treatment in moderately to severely active UC patients have been recently published (N Engl J Med. 2017;376:1723-36). The rates of clinical remission at week 8 were significantly greater in patients who were treated with 10 mg tofacitinib than placebo in both induction trials, and results were similar regardless of anti-TNF exposure status. Clinical responders in the induction studies were randomized to placebo or two doses of tofacitinib. At week 52, remission rates were significantly higher in the patients treated with 10 mg tofacitinib twice daily and 5 mg tofacitinib twice daily than those receiving placebo. The percentages of tofacitinib-treated patients who achieved mucosal healing were significantly greater than those in the placebo group. Serious infections occurred significantly more frequently in the tofacitinib than placebo group during induction, but not during maintenance. However, rates of herpes zoster were higher with maintenance therapy at 10 mg twice daily (5.1%) than with placebo (0.5%). A recently published phase 2 study of filgotinib, a selective JAK1 inhibitor, reported that the remission rate at week 10 was significantly higher in active CD patients receiving 200 mg of filgotinib daily than in those receiving placebo (Lancet 2017;389:266-75). A phase 2 trial of another selective JAK1 inhibitor, upadacitinib (ABT-494), for induction therapy in CD patients with a history of failure or intolerance to TNF-antagonists, was presented at DDW (Gastroenterology 2017;152[5 Suppl 1]:S1308-9). Higher rates of clinical remission at week 16 were seen in patients on 6 mg upadacitinib twice daily than placebo, and several doses of upadacitinib were significantly better than placebo for inducing endoscopic remission at week 12 or 16. Serious adverse events were seen in 9%-15% of CD patients treated with these two agents (vs. 4%-5% in placebo-treated patients).
Smad7 regulates the signaling of transforming growth factor (TGF)-beta1, an anti-inflammatory cytokine. Mongersen is an orally delivered anti-sense oligonucleotide that inhibits Smad7 and restores TGF-beta1 signaling, and is being developed for CD. The efficacy of induction therapy for active CD patients with limited active disease (terminal ileum or proximal colon) was demonstrated in a phase 2 study (N Engl J Med. 2015;372:1104-13). Interestingly, this study showed significantly higher rates of clinical remission at day 15 with mongersen. However, there were no endoscopic data available in this trial, baseline serum C-reactive protein concentrations were low, and did not decrease significantly. This drug appears to be well tolerated, and serious adverse events were not significantly higher than for placebo. In a phase 1b study, correlations between clinical and endoscopic outcomes were explored, and among 52 CD patients, SES-CD reductions of at least 25% at week 12 were seen in 37% of mongersen-treated patients (Gastroenterology. 2017;152[5 Suppl 1]:S198).
In summary, the future of IBD medical therapy is bright due to the recent introduction of therapies with novel mechanisms of action and favorable safety profiles (e.g., vedolizumab and ustekinumab), potentially lower-cost biosimilars, and multiple compounds in the drug development pipeline.
Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.
Copper IUDs increase bacterial vaginosis risk
PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.
This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.
The African women in this study were all free of HIV and sexually transmitted infections; on average, they were about 26 years old; and most were married and sexually active. As part of a larger look into the role of vaginal dysbiosis in HIV acquisition, they were given five options for contraception: three kinds of injectables; one implant; and the nonhormonal copper IUD.
The women were divided almost evenly among the five options. The researchers followed them for 6 months with routine vaginal swabs and polymerase chain reaction testing during the follicular phase of menses. Women who opted for the copper IUD were slightly less likely to report being married and sexually active.
Almost a third of the women had BV at baseline, a little higher than the prevalence in American women.
Women who opted for hormonal contraceptives had no change in BV prevalence or vaginal microbiota.
However, BV prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days. There was an increase in concentrations of Gardnerella vaginalis and Atopobium vaginae that was not seen in the hormonal contraception groups. Overall, copper IUDs showed a twofold increase in the relative risk of BV.
“I don’t think there’s anything here that’s particularly alarming. This would not dissuade me from recommending a copper IUD. It’s a very effective and safe nonhormonal way of having long-acting reversible contraception, but if a woman gets a copper IUD and she has recurrent BV, you need to understand that the IUD may be playing a role,” Dr. Hillier said in an interview at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.
The increased risk is probably because IUDs cause heavier and longer menstrual bleeding, which is known to disturb the vaginal microbiome. Work is underway to see if removing the IUD reverses the effects, Dr. Hillier said.
Most of the women in the study opted to keep their IUDs in place after 6 months.
The Gates Foundation supported the work. Dr. Hillier is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.
This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.
The African women in this study were all free of HIV and sexually transmitted infections; on average, they were about 26 years old; and most were married and sexually active. As part of a larger look into the role of vaginal dysbiosis in HIV acquisition, they were given five options for contraception: three kinds of injectables; one implant; and the nonhormonal copper IUD.
The women were divided almost evenly among the five options. The researchers followed them for 6 months with routine vaginal swabs and polymerase chain reaction testing during the follicular phase of menses. Women who opted for the copper IUD were slightly less likely to report being married and sexually active.
Almost a third of the women had BV at baseline, a little higher than the prevalence in American women.
Women who opted for hormonal contraceptives had no change in BV prevalence or vaginal microbiota.
However, BV prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days. There was an increase in concentrations of Gardnerella vaginalis and Atopobium vaginae that was not seen in the hormonal contraception groups. Overall, copper IUDs showed a twofold increase in the relative risk of BV.
“I don’t think there’s anything here that’s particularly alarming. This would not dissuade me from recommending a copper IUD. It’s a very effective and safe nonhormonal way of having long-acting reversible contraception, but if a woman gets a copper IUD and she has recurrent BV, you need to understand that the IUD may be playing a role,” Dr. Hillier said in an interview at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.
The increased risk is probably because IUDs cause heavier and longer menstrual bleeding, which is known to disturb the vaginal microbiome. Work is underway to see if removing the IUD reverses the effects, Dr. Hillier said.
Most of the women in the study opted to keep their IUDs in place after 6 months.
The Gates Foundation supported the work. Dr. Hillier is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.
This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.
The African women in this study were all free of HIV and sexually transmitted infections; on average, they were about 26 years old; and most were married and sexually active. As part of a larger look into the role of vaginal dysbiosis in HIV acquisition, they were given five options for contraception: three kinds of injectables; one implant; and the nonhormonal copper IUD.
The women were divided almost evenly among the five options. The researchers followed them for 6 months with routine vaginal swabs and polymerase chain reaction testing during the follicular phase of menses. Women who opted for the copper IUD were slightly less likely to report being married and sexually active.
Almost a third of the women had BV at baseline, a little higher than the prevalence in American women.
Women who opted for hormonal contraceptives had no change in BV prevalence or vaginal microbiota.
However, BV prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days. There was an increase in concentrations of Gardnerella vaginalis and Atopobium vaginae that was not seen in the hormonal contraception groups. Overall, copper IUDs showed a twofold increase in the relative risk of BV.
“I don’t think there’s anything here that’s particularly alarming. This would not dissuade me from recommending a copper IUD. It’s a very effective and safe nonhormonal way of having long-acting reversible contraception, but if a woman gets a copper IUD and she has recurrent BV, you need to understand that the IUD may be playing a role,” Dr. Hillier said in an interview at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.
The increased risk is probably because IUDs cause heavier and longer menstrual bleeding, which is known to disturb the vaginal microbiome. Work is underway to see if removing the IUD reverses the effects, Dr. Hillier said.
Most of the women in the study opted to keep their IUDs in place after 6 months.
The Gates Foundation supported the work. Dr. Hillier is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
AT IDSOG
Key clinical point:
Major finding: Baterial vaginosis prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days.
Data source: A longitudinal cohort study of 234 women.
Disclosures: The Gates Foundation supported the work. The senior investigator is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
Transitioning From Pediatric to Adult Health Care: A Journey With Lennox-Gastaut Syndrome
25 Years of groundbreaking gastric cancer research
In 1992, the AGA Research Foundation issued the first AGA-R. Robert and Sally D. Funderburg Research Award in Gastric Cancer to support research into this previously underfunded area. There have been 26 recipients of the AGA-Funderburg award to date, comprising an honor role of distinguished national leaders in gastroenterology. Each recipient has addressed different aspects of the disease, providing a dramatic improvement in the understanding and treatment of gastric cancer.
The AGA Research Foundation is thankful for the continuous funding from the Funderburg family, which has provided the opportunity for gastric cancer research discoveries that otherwise would not have been funded. Learn more about the Funderburgs and the impact of this award in AGA Perspectives, http://agaperspectives.gastro.org/reflecting-25-years-groundbreaking-gastric-cancer-research.
In 1992, the AGA Research Foundation issued the first AGA-R. Robert and Sally D. Funderburg Research Award in Gastric Cancer to support research into this previously underfunded area. There have been 26 recipients of the AGA-Funderburg award to date, comprising an honor role of distinguished national leaders in gastroenterology. Each recipient has addressed different aspects of the disease, providing a dramatic improvement in the understanding and treatment of gastric cancer.
The AGA Research Foundation is thankful for the continuous funding from the Funderburg family, which has provided the opportunity for gastric cancer research discoveries that otherwise would not have been funded. Learn more about the Funderburgs and the impact of this award in AGA Perspectives, http://agaperspectives.gastro.org/reflecting-25-years-groundbreaking-gastric-cancer-research.
In 1992, the AGA Research Foundation issued the first AGA-R. Robert and Sally D. Funderburg Research Award in Gastric Cancer to support research into this previously underfunded area. There have been 26 recipients of the AGA-Funderburg award to date, comprising an honor role of distinguished national leaders in gastroenterology. Each recipient has addressed different aspects of the disease, providing a dramatic improvement in the understanding and treatment of gastric cancer.
The AGA Research Foundation is thankful for the continuous funding from the Funderburg family, which has provided the opportunity for gastric cancer research discoveries that otherwise would not have been funded. Learn more about the Funderburgs and the impact of this award in AGA Perspectives, http://agaperspectives.gastro.org/reflecting-25-years-groundbreaking-gastric-cancer-research.
What are the complications of proton pump inhibitor therapy?
Talking to your patients about PPIs
AGA has developed talking points about research released associating PPIs with dementia, chronic kidney disease, and the latest research associating PPI use with all-cause mortality. These resources can help you educate your patients on the data and on the risks and benefits of using PPIs in their care.
- • PPIs and dementia: http://www.gastro.org/news_items/2017/07/20/how-to-talk-with-your-patients-about-ppis-and-dementia.
- • PPIs and chronic kidney disease: http://www.gastro.org/news_items/how-to-talk-with-patients-about-ppis-and-chronic-kidney-disease.
- • PPIs and all-cause mortality: http://www.gastro.org/news_items/a-guide-to-conversations-about-the-latest-ppi-research-results.
Talking to your colleagues about PPIs
AGA members have been discussing this new data linking PPIs to death. Weigh in by visiting the AGA Community, www.community.gastro.org.
Talking to your patients about PPIs
AGA has developed talking points about research released associating PPIs with dementia, chronic kidney disease, and the latest research associating PPI use with all-cause mortality. These resources can help you educate your patients on the data and on the risks and benefits of using PPIs in their care.
- • PPIs and dementia: http://www.gastro.org/news_items/2017/07/20/how-to-talk-with-your-patients-about-ppis-and-dementia.
- • PPIs and chronic kidney disease: http://www.gastro.org/news_items/how-to-talk-with-patients-about-ppis-and-chronic-kidney-disease.
- • PPIs and all-cause mortality: http://www.gastro.org/news_items/a-guide-to-conversations-about-the-latest-ppi-research-results.
Talking to your colleagues about PPIs
AGA members have been discussing this new data linking PPIs to death. Weigh in by visiting the AGA Community, www.community.gastro.org.
Talking to your patients about PPIs
AGA has developed talking points about research released associating PPIs with dementia, chronic kidney disease, and the latest research associating PPI use with all-cause mortality. These resources can help you educate your patients on the data and on the risks and benefits of using PPIs in their care.
- • PPIs and dementia: http://www.gastro.org/news_items/2017/07/20/how-to-talk-with-your-patients-about-ppis-and-dementia.
- • PPIs and chronic kidney disease: http://www.gastro.org/news_items/how-to-talk-with-patients-about-ppis-and-chronic-kidney-disease.
- • PPIs and all-cause mortality: http://www.gastro.org/news_items/a-guide-to-conversations-about-the-latest-ppi-research-results.
Talking to your colleagues about PPIs
AGA members have been discussing this new data linking PPIs to death. Weigh in by visiting the AGA Community, www.community.gastro.org.
Use the AGA Clinical Guidelines app to participate in MACRA
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
AGA Future Leaders Program receives national recognition
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
Pediatric News welcomes Dr. Lenore Jarvis
Pediatric News welcomes Lenore Jarvis MD, MEd, to its editorial advisory board.
Dr. Jarvis is a pediatric emergency medicine physician at Children’s National Health System, and assistant professor of pediatrics at George Washington University, both in Washington.
Pediatric News welcomes Lenore Jarvis MD, MEd, to its editorial advisory board.
Dr. Jarvis is a pediatric emergency medicine physician at Children’s National Health System, and assistant professor of pediatrics at George Washington University, both in Washington.
Pediatric News welcomes Lenore Jarvis MD, MEd, to its editorial advisory board.
Dr. Jarvis is a pediatric emergency medicine physician at Children’s National Health System, and assistant professor of pediatrics at George Washington University, both in Washington.
MBSAQIP data helped target problem areas to cut readmissions
NEW YORK – Targeted interventions aimed at reducing patient readmission after bariatric surgery at a high-volume academic medical center led to a 61% overall decrease year over year. The center also saw a substantial reduction in readmissions linked to the top three factors of readmission identified by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, as well as a precipitous drop in the revisional surgery readmission rate.
“Our center, like so many others, has quarterly meetings in accordance with the MBSAQIP to look at our data. And this led to recognition of some common reasons for readmission,” said Chetan V. Aher, MD, a general surgeon at the department of surgery at Vanderbilt University Medical Center in Nashville, Tenn. Oral (PO) intolerance, dehydration, and nonemergent abdominal pain were the top reasons flagged by the MBSAQIP registry data at the medical center. Dr. Aher and his colleagues moved to focus on postoperative diet, administration of medications, management of patients who return to the hospital after surgery, and optimal staffing.
“Notably, the readmission rate for revisional procedures decreased by a whopping 90%,” Dr. Aher said. “I think a lot of these targeted interventions just really helped these patients who were at a higher risk to begin with to be readmitted.”
New dietary dos and don’ts
“We changed our postoperative diet,” Dr. Aher said. Instead of a soft food diet a couple of days after surgery, the full liquid diet was extended to 3 weeks post surgery.
The clinicians also implemented what they called a ‘no MEALS’ policy, which stands for no Meat, Eggs And Leftovers. “We were having problems with meat, although tender fish was okay, and some other things that went down easily,” Dr. Aher said at the American College of Surgeons Quality and Safety Conference. “We had some complaints about no eggs after surgery. A lot of patients love eggs,” he added. But they recommended avoiding eggs for 1 month after bariatric surgery to avoid nausea.
“Avoiding leftovers was also a big deal for patients,” Dr. Aher said. But patients who microwaved leftovers would “then come into the hospital with problems.”
Medication modifications
Another frequent cause of nausea was a “terrible and off-putting” taste when crushed tablets or medication capsules were added to the patient’s diet. Changing how patients took their medication “was a big help.” At the same time, there was a large institutional effort at Vanderbilt to start providing discharge medications in the hospital to increase postoperative compliance. “Bariatric surgery was one of the pilot programs for this,” Dr. Aher said. Discharge medications were filled by the pharmacy at Vanderbilt and delivered to the patient’s room, and a pharmacist or pharmacy intern explained how to use them. Compliance on medications increased, which may in turn have had an impact on readmissions.
Changes to patient management
Dr. Aher and his colleagues also changed where they treated patients who returned with problems. “Previously, when patients called in, the clinic diverted them to the emergency room. We stopped doing that, and increased our capacity to see these patients in the clinic instead.” This led to an increase in use of IV hydration in the clinic.
A meeting attendee asked if providing this service led to any problems with clinic capacity.
“Sometimes,” Dr. Aher said. “We don’t have a huge number of patients coming in for IV hydration, but when we had two come in on the same day, it did take up a couple of exam rooms.” To address this, the clinicians found other space in the clinic that would offer privacy for patients while not tying up exam rooms.
In addition, the clinic expanded nurse practitioner availability to 5 days a week to make the discharge process more consistent. “Of course, as we rolled all these things out, we made sure our educational material was updated accordingly,” Dr. Aher said.
The study demonstrates that a collaborative team effort and targeted interventions can result in a significant reduction in readmissions, Dr. Aher said. “Regular quality focused meetings are really important to facilitate recognition of various areas for improvement, especially in a high-volume center. Introducing an MBSAQIP registry serves as an excellent tool to effect these changes,” he said.
Dr. Aher had no relevant financial disclosures.
NEW YORK – Targeted interventions aimed at reducing patient readmission after bariatric surgery at a high-volume academic medical center led to a 61% overall decrease year over year. The center also saw a substantial reduction in readmissions linked to the top three factors of readmission identified by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, as well as a precipitous drop in the revisional surgery readmission rate.
“Our center, like so many others, has quarterly meetings in accordance with the MBSAQIP to look at our data. And this led to recognition of some common reasons for readmission,” said Chetan V. Aher, MD, a general surgeon at the department of surgery at Vanderbilt University Medical Center in Nashville, Tenn. Oral (PO) intolerance, dehydration, and nonemergent abdominal pain were the top reasons flagged by the MBSAQIP registry data at the medical center. Dr. Aher and his colleagues moved to focus on postoperative diet, administration of medications, management of patients who return to the hospital after surgery, and optimal staffing.
“Notably, the readmission rate for revisional procedures decreased by a whopping 90%,” Dr. Aher said. “I think a lot of these targeted interventions just really helped these patients who were at a higher risk to begin with to be readmitted.”
New dietary dos and don’ts
“We changed our postoperative diet,” Dr. Aher said. Instead of a soft food diet a couple of days after surgery, the full liquid diet was extended to 3 weeks post surgery.
The clinicians also implemented what they called a ‘no MEALS’ policy, which stands for no Meat, Eggs And Leftovers. “We were having problems with meat, although tender fish was okay, and some other things that went down easily,” Dr. Aher said at the American College of Surgeons Quality and Safety Conference. “We had some complaints about no eggs after surgery. A lot of patients love eggs,” he added. But they recommended avoiding eggs for 1 month after bariatric surgery to avoid nausea.
“Avoiding leftovers was also a big deal for patients,” Dr. Aher said. But patients who microwaved leftovers would “then come into the hospital with problems.”
Medication modifications
Another frequent cause of nausea was a “terrible and off-putting” taste when crushed tablets or medication capsules were added to the patient’s diet. Changing how patients took their medication “was a big help.” At the same time, there was a large institutional effort at Vanderbilt to start providing discharge medications in the hospital to increase postoperative compliance. “Bariatric surgery was one of the pilot programs for this,” Dr. Aher said. Discharge medications were filled by the pharmacy at Vanderbilt and delivered to the patient’s room, and a pharmacist or pharmacy intern explained how to use them. Compliance on medications increased, which may in turn have had an impact on readmissions.
Changes to patient management
Dr. Aher and his colleagues also changed where they treated patients who returned with problems. “Previously, when patients called in, the clinic diverted them to the emergency room. We stopped doing that, and increased our capacity to see these patients in the clinic instead.” This led to an increase in use of IV hydration in the clinic.
A meeting attendee asked if providing this service led to any problems with clinic capacity.
“Sometimes,” Dr. Aher said. “We don’t have a huge number of patients coming in for IV hydration, but when we had two come in on the same day, it did take up a couple of exam rooms.” To address this, the clinicians found other space in the clinic that would offer privacy for patients while not tying up exam rooms.
In addition, the clinic expanded nurse practitioner availability to 5 days a week to make the discharge process more consistent. “Of course, as we rolled all these things out, we made sure our educational material was updated accordingly,” Dr. Aher said.
The study demonstrates that a collaborative team effort and targeted interventions can result in a significant reduction in readmissions, Dr. Aher said. “Regular quality focused meetings are really important to facilitate recognition of various areas for improvement, especially in a high-volume center. Introducing an MBSAQIP registry serves as an excellent tool to effect these changes,” he said.
Dr. Aher had no relevant financial disclosures.
NEW YORK – Targeted interventions aimed at reducing patient readmission after bariatric surgery at a high-volume academic medical center led to a 61% overall decrease year over year. The center also saw a substantial reduction in readmissions linked to the top three factors of readmission identified by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, as well as a precipitous drop in the revisional surgery readmission rate.
“Our center, like so many others, has quarterly meetings in accordance with the MBSAQIP to look at our data. And this led to recognition of some common reasons for readmission,” said Chetan V. Aher, MD, a general surgeon at the department of surgery at Vanderbilt University Medical Center in Nashville, Tenn. Oral (PO) intolerance, dehydration, and nonemergent abdominal pain were the top reasons flagged by the MBSAQIP registry data at the medical center. Dr. Aher and his colleagues moved to focus on postoperative diet, administration of medications, management of patients who return to the hospital after surgery, and optimal staffing.
“Notably, the readmission rate for revisional procedures decreased by a whopping 90%,” Dr. Aher said. “I think a lot of these targeted interventions just really helped these patients who were at a higher risk to begin with to be readmitted.”
New dietary dos and don’ts
“We changed our postoperative diet,” Dr. Aher said. Instead of a soft food diet a couple of days after surgery, the full liquid diet was extended to 3 weeks post surgery.
The clinicians also implemented what they called a ‘no MEALS’ policy, which stands for no Meat, Eggs And Leftovers. “We were having problems with meat, although tender fish was okay, and some other things that went down easily,” Dr. Aher said at the American College of Surgeons Quality and Safety Conference. “We had some complaints about no eggs after surgery. A lot of patients love eggs,” he added. But they recommended avoiding eggs for 1 month after bariatric surgery to avoid nausea.
“Avoiding leftovers was also a big deal for patients,” Dr. Aher said. But patients who microwaved leftovers would “then come into the hospital with problems.”
Medication modifications
Another frequent cause of nausea was a “terrible and off-putting” taste when crushed tablets or medication capsules were added to the patient’s diet. Changing how patients took their medication “was a big help.” At the same time, there was a large institutional effort at Vanderbilt to start providing discharge medications in the hospital to increase postoperative compliance. “Bariatric surgery was one of the pilot programs for this,” Dr. Aher said. Discharge medications were filled by the pharmacy at Vanderbilt and delivered to the patient’s room, and a pharmacist or pharmacy intern explained how to use them. Compliance on medications increased, which may in turn have had an impact on readmissions.
Changes to patient management
Dr. Aher and his colleagues also changed where they treated patients who returned with problems. “Previously, when patients called in, the clinic diverted them to the emergency room. We stopped doing that, and increased our capacity to see these patients in the clinic instead.” This led to an increase in use of IV hydration in the clinic.
A meeting attendee asked if providing this service led to any problems with clinic capacity.
“Sometimes,” Dr. Aher said. “We don’t have a huge number of patients coming in for IV hydration, but when we had two come in on the same day, it did take up a couple of exam rooms.” To address this, the clinicians found other space in the clinic that would offer privacy for patients while not tying up exam rooms.
In addition, the clinic expanded nurse practitioner availability to 5 days a week to make the discharge process more consistent. “Of course, as we rolled all these things out, we made sure our educational material was updated accordingly,” Dr. Aher said.
The study demonstrates that a collaborative team effort and targeted interventions can result in a significant reduction in readmissions, Dr. Aher said. “Regular quality focused meetings are really important to facilitate recognition of various areas for improvement, especially in a high-volume center. Introducing an MBSAQIP registry serves as an excellent tool to effect these changes,” he said.
Dr. Aher had no relevant financial disclosures.
AT THE ACS QUALITY & SAFETY CONFERENCE
Key clinical point: A collaborative effort and target interventions can successfully reduce bariatric surgery readmissions.
Major finding: The overall bariatric surgery readmission rate dropped 61% in the year after intervention compared to the previous year.
Data source: Comparison of 471 bariatric procedures in 2015 to 539 others in 2016 at Vanderbilt University Medical Center.
Disclosures: Dr. Aher had no relevant financial disclosures.
Managing hospital- and ventilator-associated pneumonia
Background
Hospital-acquired pneumonia (HAP) is defined as pneumonia that develops 48 hours or more after admission that was not present on admission; and ventilator-associated pneumonia (VAP) is pneumonia that develops 48 hours or more after endotracheal intubation.
HAP and VAP are common afflictions in hospitalized patients, accounting for nearly one-quarter of all hospital-acquired infections. They confer mortality rates of 24%-50%, increasing to nearly 75% if caused by resistant organisms.1,2 Given the high prevalence and significant mortality associated with these types of pneumonia, diagnosis and treatment are essential. Treatment must be balanced against potential unintended consequences of antibiotic use including Clostridium difficile infections and the promotion of resistant bacteria caused by poor antibiotic stewardship.
Given the frequency with which HAP and VAP occur, and the need for equipoise with antibiotic use, it is essential that all practicing clinicians have an evidence-based construct for the diagnosis and treatment of HAP and VAP.
Guideline updates
In 2016, the Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS) reconvened after 11 years to update their recommendations for the treatment of HAP and VAP.2 The decision to update their recommendations was based on the availability of new evidence regarding the diagnosis and treatment of these conditions.
Included in this review are guideline updates on methods for diagnosis, initial antibiotic choice, pathogen-specific therapy, and duration of therapy. The guidelines also have recommendations for the role of inhaled antibiotics and pharmacokinetic optimization of antibiotic dosing, which will not be reviewed here.
Methods for Diagnosis: The use of semi-quantitative, noninvasive sampling of respiratory cultures is preferred for HAP and VAP, rather than empiric treatment or quantitative cultures (i.e., bronchoalveolar lavage, protected-specimen brush and blind bronchial sampling).
Initial antibiotic choice: For HAP and VAP, clinicians should include therapy targeting S. aureus, Pseudomonas aeruginosa, and other gram-negative bacilli. Therapy for methicillin-resistant S. aureus should be included if patients are at high risk for death (i.e., septic shock or ventilated patients) or if local drug-resistant prevalence is greater than 10%-20%. Similarly, two antipseudomonal antibiotics should be used only with empiric therapy if the patient is at high risk for mortality or local drug-resistant prevalence is greater than 10%.
Duration of therapy: HAP and VAP should be treated for 7 days with regimens that are tailored to culture data when available, assuming there has been appropriate clinical response. Procalcitonin may be paired with clinical judgment when considering antibiotic discontinuation.
Guideline analysis
There are several notable differences between the 2016 IDSA/ATS guidelines and the 2005 guidelines.3 The earlier guidelines recommended strong consideration of invasive respiratory cultures such as bronchoalveolar lavage or protected-specimen brush sampling for HAP/VAP. It is now recommended that only noninvasive cultures be performed in most clinical scenarios.
Last, the updated guidelines recommend dual therapy for potential or documented Pseudomonas infection only for patients at high risk for mortality or in hospitals with a high prevalence of antibiotic resistance; previously, dual antipseudomonal therapy was recommended for all cases of HAP and VAP, based upon the risk of developing resistant strains with monotherapy.3
Since 2005, several organizations have released guidelines addressing the management of HAP and VAP.1,4,5,6 These are largely in keeping with the current version released by the IDSA/ATS. Across all guidelines, there is a focus on the importance of local antibiograms for appropriate and effective treatment, and the use of noninvasive culture data to guide therapy. Also, all groups recommend a short-course (7-8 days) of antibiotics for both HAP and VAP, assuming there has been an appropriate clinical response. The recent Canadian guidelines have one unique recommendation, which is to avoid the use of ceftazidime for suspected Pseudomonas pneumonia, based upon inferior outcomes when compared to alternative regimens.5
Takeaways
When considering the diagnosis of HAP and VAP, clinicians should be aware that the category of HCAP has been removed from current guidelines, and methods for microbiological diagnosis have been simplified.7 In addition, initial antibiotic selection should rely on institution-specific antibiograms and local resistance patterns when available. Recommended duration of therapy has been shortened, and should not include aminoglycosides.
Finally, antibiotic stewardship is the responsibility of each clinician and de-escalation of therapy for HAP and VAP should be guided by available respiratory cultures.
Dr. Hippensteel is a pulmonologist in Aurora, Colo. Dr. Sippel is visiting associate professor of clinical practice, medicine-pulmonary sciences & critical care at the University of Colorado School of Medicine.
References
1. Masterton R, Galloway A, French G, Street M, Armstrong J, Brown E, Cleverley J, Dilworth P, Fry C, Gascoigne A. Guidelines for the management of hospital-acquired pneumonia in the UK: report of the working party on hospital-acquired pneumonia of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother. 2008;62(1):5-34.
2. Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O’grady NP, Bartlett JG, Carratalà J. Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016:ciw353.
3. Society AT, America IDSo. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005;171(4):388-416.
4. Dalhoff K, Abele-Horn M, Andreas S, Bauer T, von Baum H, Deja M, Ewig S, Gastmeier P, Gatermann S, Gerlach H. Epidemiology, diagnosis, and treatment of adult patients with nosocomial pneumonia. S-3 Guideline of the German Society for Anaesthesiology and Intensive Care Medicine, the German Society for Infectious Diseases, the German Society for Hygiene and Microbiology, the German Respiratory Society and the Paul-Ehrlich-Society for Chemotherapy. Pneumologie (Stuttgart, Germany). 2012;66(12):707-65.
5. Rotstein C, Evans G, Born A, Grossman R, Light RB, Magder S, McTaggart B, Weiss K, Zhanel GG. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases and Medical Microbiology. 2008;19(1):19-53.
6. Coffin SE, Klompas M, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Dubberke ER, Fraser V. Strategies to prevent ventilator-associated pneumonia in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(S1):S31-S40.
7. Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R. Guidelines for preventing healthcare-associated pneumonia, 2003. MMWR. 2004;53(RR-3):1-36.
Background
Hospital-acquired pneumonia (HAP) is defined as pneumonia that develops 48 hours or more after admission that was not present on admission; and ventilator-associated pneumonia (VAP) is pneumonia that develops 48 hours or more after endotracheal intubation.
HAP and VAP are common afflictions in hospitalized patients, accounting for nearly one-quarter of all hospital-acquired infections. They confer mortality rates of 24%-50%, increasing to nearly 75% if caused by resistant organisms.1,2 Given the high prevalence and significant mortality associated with these types of pneumonia, diagnosis and treatment are essential. Treatment must be balanced against potential unintended consequences of antibiotic use including Clostridium difficile infections and the promotion of resistant bacteria caused by poor antibiotic stewardship.
Given the frequency with which HAP and VAP occur, and the need for equipoise with antibiotic use, it is essential that all practicing clinicians have an evidence-based construct for the diagnosis and treatment of HAP and VAP.
Guideline updates
In 2016, the Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS) reconvened after 11 years to update their recommendations for the treatment of HAP and VAP.2 The decision to update their recommendations was based on the availability of new evidence regarding the diagnosis and treatment of these conditions.
Included in this review are guideline updates on methods for diagnosis, initial antibiotic choice, pathogen-specific therapy, and duration of therapy. The guidelines also have recommendations for the role of inhaled antibiotics and pharmacokinetic optimization of antibiotic dosing, which will not be reviewed here.
Methods for Diagnosis: The use of semi-quantitative, noninvasive sampling of respiratory cultures is preferred for HAP and VAP, rather than empiric treatment or quantitative cultures (i.e., bronchoalveolar lavage, protected-specimen brush and blind bronchial sampling).
Initial antibiotic choice: For HAP and VAP, clinicians should include therapy targeting S. aureus, Pseudomonas aeruginosa, and other gram-negative bacilli. Therapy for methicillin-resistant S. aureus should be included if patients are at high risk for death (i.e., septic shock or ventilated patients) or if local drug-resistant prevalence is greater than 10%-20%. Similarly, two antipseudomonal antibiotics should be used only with empiric therapy if the patient is at high risk for mortality or local drug-resistant prevalence is greater than 10%.
Duration of therapy: HAP and VAP should be treated for 7 days with regimens that are tailored to culture data when available, assuming there has been appropriate clinical response. Procalcitonin may be paired with clinical judgment when considering antibiotic discontinuation.
Guideline analysis
There are several notable differences between the 2016 IDSA/ATS guidelines and the 2005 guidelines.3 The earlier guidelines recommended strong consideration of invasive respiratory cultures such as bronchoalveolar lavage or protected-specimen brush sampling for HAP/VAP. It is now recommended that only noninvasive cultures be performed in most clinical scenarios.
Last, the updated guidelines recommend dual therapy for potential or documented Pseudomonas infection only for patients at high risk for mortality or in hospitals with a high prevalence of antibiotic resistance; previously, dual antipseudomonal therapy was recommended for all cases of HAP and VAP, based upon the risk of developing resistant strains with monotherapy.3
Since 2005, several organizations have released guidelines addressing the management of HAP and VAP.1,4,5,6 These are largely in keeping with the current version released by the IDSA/ATS. Across all guidelines, there is a focus on the importance of local antibiograms for appropriate and effective treatment, and the use of noninvasive culture data to guide therapy. Also, all groups recommend a short-course (7-8 days) of antibiotics for both HAP and VAP, assuming there has been an appropriate clinical response. The recent Canadian guidelines have one unique recommendation, which is to avoid the use of ceftazidime for suspected Pseudomonas pneumonia, based upon inferior outcomes when compared to alternative regimens.5
Takeaways
When considering the diagnosis of HAP and VAP, clinicians should be aware that the category of HCAP has been removed from current guidelines, and methods for microbiological diagnosis have been simplified.7 In addition, initial antibiotic selection should rely on institution-specific antibiograms and local resistance patterns when available. Recommended duration of therapy has been shortened, and should not include aminoglycosides.
Finally, antibiotic stewardship is the responsibility of each clinician and de-escalation of therapy for HAP and VAP should be guided by available respiratory cultures.
Dr. Hippensteel is a pulmonologist in Aurora, Colo. Dr. Sippel is visiting associate professor of clinical practice, medicine-pulmonary sciences & critical care at the University of Colorado School of Medicine.
References
1. Masterton R, Galloway A, French G, Street M, Armstrong J, Brown E, Cleverley J, Dilworth P, Fry C, Gascoigne A. Guidelines for the management of hospital-acquired pneumonia in the UK: report of the working party on hospital-acquired pneumonia of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother. 2008;62(1):5-34.
2. Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O’grady NP, Bartlett JG, Carratalà J. Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016:ciw353.
3. Society AT, America IDSo. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005;171(4):388-416.
4. Dalhoff K, Abele-Horn M, Andreas S, Bauer T, von Baum H, Deja M, Ewig S, Gastmeier P, Gatermann S, Gerlach H. Epidemiology, diagnosis, and treatment of adult patients with nosocomial pneumonia. S-3 Guideline of the German Society for Anaesthesiology and Intensive Care Medicine, the German Society for Infectious Diseases, the German Society for Hygiene and Microbiology, the German Respiratory Society and the Paul-Ehrlich-Society for Chemotherapy. Pneumologie (Stuttgart, Germany). 2012;66(12):707-65.
5. Rotstein C, Evans G, Born A, Grossman R, Light RB, Magder S, McTaggart B, Weiss K, Zhanel GG. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases and Medical Microbiology. 2008;19(1):19-53.
6. Coffin SE, Klompas M, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Dubberke ER, Fraser V. Strategies to prevent ventilator-associated pneumonia in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(S1):S31-S40.
7. Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R. Guidelines for preventing healthcare-associated pneumonia, 2003. MMWR. 2004;53(RR-3):1-36.
Background
Hospital-acquired pneumonia (HAP) is defined as pneumonia that develops 48 hours or more after admission that was not present on admission; and ventilator-associated pneumonia (VAP) is pneumonia that develops 48 hours or more after endotracheal intubation.
HAP and VAP are common afflictions in hospitalized patients, accounting for nearly one-quarter of all hospital-acquired infections. They confer mortality rates of 24%-50%, increasing to nearly 75% if caused by resistant organisms.1,2 Given the high prevalence and significant mortality associated with these types of pneumonia, diagnosis and treatment are essential. Treatment must be balanced against potential unintended consequences of antibiotic use including Clostridium difficile infections and the promotion of resistant bacteria caused by poor antibiotic stewardship.
Given the frequency with which HAP and VAP occur, and the need for equipoise with antibiotic use, it is essential that all practicing clinicians have an evidence-based construct for the diagnosis and treatment of HAP and VAP.
Guideline updates
In 2016, the Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS) reconvened after 11 years to update their recommendations for the treatment of HAP and VAP.2 The decision to update their recommendations was based on the availability of new evidence regarding the diagnosis and treatment of these conditions.
Included in this review are guideline updates on methods for diagnosis, initial antibiotic choice, pathogen-specific therapy, and duration of therapy. The guidelines also have recommendations for the role of inhaled antibiotics and pharmacokinetic optimization of antibiotic dosing, which will not be reviewed here.
Methods for Diagnosis: The use of semi-quantitative, noninvasive sampling of respiratory cultures is preferred for HAP and VAP, rather than empiric treatment or quantitative cultures (i.e., bronchoalveolar lavage, protected-specimen brush and blind bronchial sampling).
Initial antibiotic choice: For HAP and VAP, clinicians should include therapy targeting S. aureus, Pseudomonas aeruginosa, and other gram-negative bacilli. Therapy for methicillin-resistant S. aureus should be included if patients are at high risk for death (i.e., septic shock or ventilated patients) or if local drug-resistant prevalence is greater than 10%-20%. Similarly, two antipseudomonal antibiotics should be used only with empiric therapy if the patient is at high risk for mortality or local drug-resistant prevalence is greater than 10%.
Duration of therapy: HAP and VAP should be treated for 7 days with regimens that are tailored to culture data when available, assuming there has been appropriate clinical response. Procalcitonin may be paired with clinical judgment when considering antibiotic discontinuation.
Guideline analysis
There are several notable differences between the 2016 IDSA/ATS guidelines and the 2005 guidelines.3 The earlier guidelines recommended strong consideration of invasive respiratory cultures such as bronchoalveolar lavage or protected-specimen brush sampling for HAP/VAP. It is now recommended that only noninvasive cultures be performed in most clinical scenarios.
Last, the updated guidelines recommend dual therapy for potential or documented Pseudomonas infection only for patients at high risk for mortality or in hospitals with a high prevalence of antibiotic resistance; previously, dual antipseudomonal therapy was recommended for all cases of HAP and VAP, based upon the risk of developing resistant strains with monotherapy.3
Since 2005, several organizations have released guidelines addressing the management of HAP and VAP.1,4,5,6 These are largely in keeping with the current version released by the IDSA/ATS. Across all guidelines, there is a focus on the importance of local antibiograms for appropriate and effective treatment, and the use of noninvasive culture data to guide therapy. Also, all groups recommend a short-course (7-8 days) of antibiotics for both HAP and VAP, assuming there has been an appropriate clinical response. The recent Canadian guidelines have one unique recommendation, which is to avoid the use of ceftazidime for suspected Pseudomonas pneumonia, based upon inferior outcomes when compared to alternative regimens.5
Takeaways
When considering the diagnosis of HAP and VAP, clinicians should be aware that the category of HCAP has been removed from current guidelines, and methods for microbiological diagnosis have been simplified.7 In addition, initial antibiotic selection should rely on institution-specific antibiograms and local resistance patterns when available. Recommended duration of therapy has been shortened, and should not include aminoglycosides.
Finally, antibiotic stewardship is the responsibility of each clinician and de-escalation of therapy for HAP and VAP should be guided by available respiratory cultures.
Dr. Hippensteel is a pulmonologist in Aurora, Colo. Dr. Sippel is visiting associate professor of clinical practice, medicine-pulmonary sciences & critical care at the University of Colorado School of Medicine.
References
1. Masterton R, Galloway A, French G, Street M, Armstrong J, Brown E, Cleverley J, Dilworth P, Fry C, Gascoigne A. Guidelines for the management of hospital-acquired pneumonia in the UK: report of the working party on hospital-acquired pneumonia of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother. 2008;62(1):5-34.
2. Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O’grady NP, Bartlett JG, Carratalà J. Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016:ciw353.
3. Society AT, America IDSo. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005;171(4):388-416.
4. Dalhoff K, Abele-Horn M, Andreas S, Bauer T, von Baum H, Deja M, Ewig S, Gastmeier P, Gatermann S, Gerlach H. Epidemiology, diagnosis, and treatment of adult patients with nosocomial pneumonia. S-3 Guideline of the German Society for Anaesthesiology and Intensive Care Medicine, the German Society for Infectious Diseases, the German Society for Hygiene and Microbiology, the German Respiratory Society and the Paul-Ehrlich-Society for Chemotherapy. Pneumologie (Stuttgart, Germany). 2012;66(12):707-65.
5. Rotstein C, Evans G, Born A, Grossman R, Light RB, Magder S, McTaggart B, Weiss K, Zhanel GG. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases and Medical Microbiology. 2008;19(1):19-53.
6. Coffin SE, Klompas M, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Dubberke ER, Fraser V. Strategies to prevent ventilator-associated pneumonia in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(S1):S31-S40.
7. Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R. Guidelines for preventing healthcare-associated pneumonia, 2003. MMWR. 2004;53(RR-3):1-36.