Abstract: Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes

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Berlowitz, D.R., et al, N Engl J Med 377(8):733, August 24, 2017

BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT) showed that a systolic blood pressure (SBP) target lower than 120 mm Hg (intensive treatment) led to lower rates of cardiovascular morbidity and mortality than a 140 mm Hg target (standard treatment). The impact of intensive treatment on patient-reported outcomes is unknown.

METHODS: This study coordinated at the Bedford (MA) Veterans Affairs Hospital assessed patient perceptions using data from SPRINT, a multicenter (n=102) trial of adults aged 50 or older with hypertension at baseline (SBP 130-180 mm Hg) and increased cardiovascular risk but without a history of diabetes or stroke who were randomized to intensive treatment (n=4678) or standard treatment (n=4683). Study endpoints were the Veterans RAND 12-Item Health Survey (Physical Component Summary score [PCS] and Mental Component Summary score [MCS] of 0-100, with higher scores indicating better health), Patient Health Questionnaire 9-item depression scale (PHQ-9, scored 0-27 with higher scores indicating worse depression), 5-point scale for patient satisfaction (from very satisfied to very dissatisfied), and 8-item scale for treatment adherence (with higher scores indicating better adherence).

RESULTS: SBP was 139.7 mm Hg at baseline, 121.4 mm Hg after intensive treatment, and 136.2 mm Hg after standard treatment. Baseline PCS was 44.6 and 44.8, respectively; MCS was 53.2 and 53.1; and PHQ-9 was 3.1 in both groups. Scores were stable and similar between groups throughout three years of follow-up, regardless of age and physical and cognitive function. Both groups were satisfied or very satisfied with their care (88% each), and adherence was similar (score of 8 in 44% each).

CONCLUSIONS: Patient-reported outcomes were similar with intensive versus standard SBP treatment among patients participating in SPRINT. 34 references ([email protected] for reprints)

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The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Berlowitz, D.R., et al, N Engl J Med 377(8):733, August 24, 2017

BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT) showed that a systolic blood pressure (SBP) target lower than 120 mm Hg (intensive treatment) led to lower rates of cardiovascular morbidity and mortality than a 140 mm Hg target (standard treatment). The impact of intensive treatment on patient-reported outcomes is unknown.

METHODS: This study coordinated at the Bedford (MA) Veterans Affairs Hospital assessed patient perceptions using data from SPRINT, a multicenter (n=102) trial of adults aged 50 or older with hypertension at baseline (SBP 130-180 mm Hg) and increased cardiovascular risk but without a history of diabetes or stroke who were randomized to intensive treatment (n=4678) or standard treatment (n=4683). Study endpoints were the Veterans RAND 12-Item Health Survey (Physical Component Summary score [PCS] and Mental Component Summary score [MCS] of 0-100, with higher scores indicating better health), Patient Health Questionnaire 9-item depression scale (PHQ-9, scored 0-27 with higher scores indicating worse depression), 5-point scale for patient satisfaction (from very satisfied to very dissatisfied), and 8-item scale for treatment adherence (with higher scores indicating better adherence).

RESULTS: SBP was 139.7 mm Hg at baseline, 121.4 mm Hg after intensive treatment, and 136.2 mm Hg after standard treatment. Baseline PCS was 44.6 and 44.8, respectively; MCS was 53.2 and 53.1; and PHQ-9 was 3.1 in both groups. Scores were stable and similar between groups throughout three years of follow-up, regardless of age and physical and cognitive function. Both groups were satisfied or very satisfied with their care (88% each), and adherence was similar (score of 8 in 44% each).

CONCLUSIONS: Patient-reported outcomes were similar with intensive versus standard SBP treatment among patients participating in SPRINT. 34 references ([email protected] for reprints)

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Berlowitz, D.R., et al, N Engl J Med 377(8):733, August 24, 2017

BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT) showed that a systolic blood pressure (SBP) target lower than 120 mm Hg (intensive treatment) led to lower rates of cardiovascular morbidity and mortality than a 140 mm Hg target (standard treatment). The impact of intensive treatment on patient-reported outcomes is unknown.

METHODS: This study coordinated at the Bedford (MA) Veterans Affairs Hospital assessed patient perceptions using data from SPRINT, a multicenter (n=102) trial of adults aged 50 or older with hypertension at baseline (SBP 130-180 mm Hg) and increased cardiovascular risk but without a history of diabetes or stroke who were randomized to intensive treatment (n=4678) or standard treatment (n=4683). Study endpoints were the Veterans RAND 12-Item Health Survey (Physical Component Summary score [PCS] and Mental Component Summary score [MCS] of 0-100, with higher scores indicating better health), Patient Health Questionnaire 9-item depression scale (PHQ-9, scored 0-27 with higher scores indicating worse depression), 5-point scale for patient satisfaction (from very satisfied to very dissatisfied), and 8-item scale for treatment adherence (with higher scores indicating better adherence).

RESULTS: SBP was 139.7 mm Hg at baseline, 121.4 mm Hg after intensive treatment, and 136.2 mm Hg after standard treatment. Baseline PCS was 44.6 and 44.8, respectively; MCS was 53.2 and 53.1; and PHQ-9 was 3.1 in both groups. Scores were stable and similar between groups throughout three years of follow-up, regardless of age and physical and cognitive function. Both groups were satisfied or very satisfied with their care (88% each), and adherence was similar (score of 8 in 44% each).

CONCLUSIONS: Patient-reported outcomes were similar with intensive versus standard SBP treatment among patients participating in SPRINT. 34 references ([email protected] for reprints)

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Sodium bicarbonate and acetylcysteine for prevention of contrast-related morbidity and mortality in CKD patients

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Clinical question: Do either intravenous sodium bicarbonate or oral acetylcysteine prevent renal morbidity and mortality in patients with chronic kidney disease (CKD) undergoing angiography?

Background: Both intravenous sodium bicarbonate and acetylcysteine are commonly used therapies aimed at preventing contrast-induced nephropathy. However, data regarding their efficacy are controversial, and prior studies have largely included patients with normal renal function.

Dr. Amanda Lusa
Study design: Multinational, randomized, controlled, double-blind, clinical trial.

Setting: Medical centers (53) throughout the United States, Australia, New Zealand, and Malaysia.

Synopsis: This study included 4,993 patients with CKD, stage III and IV, who were scheduled for angiography. The study population was predominately male (93.6%) and had diabetes (80.9%). Patients were randomized to receive either sodium bicarbonate or normal saline infusion, and oral acetylcysteine or placebo. The primary outcome was a composite of death, dialysis, or a sustained increase in creatinine by 50% at 90 days, and the secondary outcome was contrast-associated acute kidney injury. There was no interaction between sodium bicarbonate and acetylcysteine. Neither therapy prevented the primary or secondary outcome. The main limitations to this study included a very narrow demographic making the results hard to extrapolate beyond male diabetes patients receiving contrast for angiography. Overall, this study suggests that treatment with sodium bicarbonate or acetylcysteine does not improve the contrast-related morbidity and mortality in patients with CKD III and IV.

Bottom line: Neither intravenous sodium bicarbonate nor acetylcysteine led to improved renal outcomes in predominantly male patients with diabetes and baseline renal dysfunction undergoing angiography.

Citation: Weisbord SD et al. Outcomes after angiography with sodium bicarbonate and acetylcysteine. N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMal1710933.

Dr. Lusa is assistant professor of medicine, division of hospital medicine, University of Virginia.
 

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Clinical question: Do either intravenous sodium bicarbonate or oral acetylcysteine prevent renal morbidity and mortality in patients with chronic kidney disease (CKD) undergoing angiography?

Background: Both intravenous sodium bicarbonate and acetylcysteine are commonly used therapies aimed at preventing contrast-induced nephropathy. However, data regarding their efficacy are controversial, and prior studies have largely included patients with normal renal function.

Dr. Amanda Lusa
Study design: Multinational, randomized, controlled, double-blind, clinical trial.

Setting: Medical centers (53) throughout the United States, Australia, New Zealand, and Malaysia.

Synopsis: This study included 4,993 patients with CKD, stage III and IV, who were scheduled for angiography. The study population was predominately male (93.6%) and had diabetes (80.9%). Patients were randomized to receive either sodium bicarbonate or normal saline infusion, and oral acetylcysteine or placebo. The primary outcome was a composite of death, dialysis, or a sustained increase in creatinine by 50% at 90 days, and the secondary outcome was contrast-associated acute kidney injury. There was no interaction between sodium bicarbonate and acetylcysteine. Neither therapy prevented the primary or secondary outcome. The main limitations to this study included a very narrow demographic making the results hard to extrapolate beyond male diabetes patients receiving contrast for angiography. Overall, this study suggests that treatment with sodium bicarbonate or acetylcysteine does not improve the contrast-related morbidity and mortality in patients with CKD III and IV.

Bottom line: Neither intravenous sodium bicarbonate nor acetylcysteine led to improved renal outcomes in predominantly male patients with diabetes and baseline renal dysfunction undergoing angiography.

Citation: Weisbord SD et al. Outcomes after angiography with sodium bicarbonate and acetylcysteine. N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMal1710933.

Dr. Lusa is assistant professor of medicine, division of hospital medicine, University of Virginia.
 

 

Clinical question: Do either intravenous sodium bicarbonate or oral acetylcysteine prevent renal morbidity and mortality in patients with chronic kidney disease (CKD) undergoing angiography?

Background: Both intravenous sodium bicarbonate and acetylcysteine are commonly used therapies aimed at preventing contrast-induced nephropathy. However, data regarding their efficacy are controversial, and prior studies have largely included patients with normal renal function.

Dr. Amanda Lusa
Study design: Multinational, randomized, controlled, double-blind, clinical trial.

Setting: Medical centers (53) throughout the United States, Australia, New Zealand, and Malaysia.

Synopsis: This study included 4,993 patients with CKD, stage III and IV, who were scheduled for angiography. The study population was predominately male (93.6%) and had diabetes (80.9%). Patients were randomized to receive either sodium bicarbonate or normal saline infusion, and oral acetylcysteine or placebo. The primary outcome was a composite of death, dialysis, or a sustained increase in creatinine by 50% at 90 days, and the secondary outcome was contrast-associated acute kidney injury. There was no interaction between sodium bicarbonate and acetylcysteine. Neither therapy prevented the primary or secondary outcome. The main limitations to this study included a very narrow demographic making the results hard to extrapolate beyond male diabetes patients receiving contrast for angiography. Overall, this study suggests that treatment with sodium bicarbonate or acetylcysteine does not improve the contrast-related morbidity and mortality in patients with CKD III and IV.

Bottom line: Neither intravenous sodium bicarbonate nor acetylcysteine led to improved renal outcomes in predominantly male patients with diabetes and baseline renal dysfunction undergoing angiography.

Citation: Weisbord SD et al. Outcomes after angiography with sodium bicarbonate and acetylcysteine. N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMal1710933.

Dr. Lusa is assistant professor of medicine, division of hospital medicine, University of Virginia.
 

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FDA approves osimertinib for first-line advanced EGFR-mutated NSCLC

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The Food and Drug Administration has approved osimertinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.

The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License
The current approval was based an improved progression-free survival (PFS) in FLAURA, a phase 3 trial of 556 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive, unresectable or metastatic NSCLC who had not received previous systemic treatment for advanced disease. Median PFS was 18.9 months (95% confidence interval, 15.2-21.4) in the osimertinib arm and 10.2 months (95% CI, 9.6-11.1) in the standard-of-care arm of gefitinib or erlotinib (hazard ratio, 0.46; 95% CI, 0.37-0.57; P less than .0001). The confirmed overall response rate was 77% for the osimertinib arm and 69% for the standard-of-care arm, the FDA said in a press statement.

Overall survival was not evaluable at the time of the PFS analysis.

The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).

In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.

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The Food and Drug Administration has approved osimertinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.

The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License
The current approval was based an improved progression-free survival (PFS) in FLAURA, a phase 3 trial of 556 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive, unresectable or metastatic NSCLC who had not received previous systemic treatment for advanced disease. Median PFS was 18.9 months (95% confidence interval, 15.2-21.4) in the osimertinib arm and 10.2 months (95% CI, 9.6-11.1) in the standard-of-care arm of gefitinib or erlotinib (hazard ratio, 0.46; 95% CI, 0.37-0.57; P less than .0001). The confirmed overall response rate was 77% for the osimertinib arm and 69% for the standard-of-care arm, the FDA said in a press statement.

Overall survival was not evaluable at the time of the PFS analysis.

The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).

In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.

 

The Food and Drug Administration has approved osimertinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.

The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License
The current approval was based an improved progression-free survival (PFS) in FLAURA, a phase 3 trial of 556 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive, unresectable or metastatic NSCLC who had not received previous systemic treatment for advanced disease. Median PFS was 18.9 months (95% confidence interval, 15.2-21.4) in the osimertinib arm and 10.2 months (95% CI, 9.6-11.1) in the standard-of-care arm of gefitinib or erlotinib (hazard ratio, 0.46; 95% CI, 0.37-0.57; P less than .0001). The confirmed overall response rate was 77% for the osimertinib arm and 69% for the standard-of-care arm, the FDA said in a press statement.

Overall survival was not evaluable at the time of the PFS analysis.

The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).

In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.

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Nitric oxide–generating dressing holds promise for diabetic foot ulcers

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Physicians and nurses turn to a wide variety of kinds of dressings to treat patients with diabetic foot ulcers (DFU). Now, new data from an industry-funded study suggest that an experimental nitric oxide-generating dressing holds promise as a tool to reduce diabetic foot wound size in certain cases.

Balkonsky/Thinkstock

The treatment is still in the research stage, and it’s not clear whether more studies will be conducted. For now, though, “we have a topical agent which specifically treats infection as well as increases perfusion of the ulcer,” study lead author Michael E. Edmonds, MD, a professor of diabetes and endocrinology at King’s College Hospital in London, said in an interview. “The study also showed that the agent not only improved healing but significantly reduced serious adverse events related to the ulcer, which included hospitalizations and amputations.”
 

The study appeared online April 4 in Wound Repair and Regeneration.

Researchers estimate that DFUs affect as many as 4% of patients with diabetes each year, with about a quarter developing the condition over their lifetimes.

A 2014 U.S. study found that 4%-5% percentage of patients with DFUs underwent lower limb amputations over a 12-month period. The same study also estimated that DFU-related care costs as much as $13 billion a year. (Diabetes Care. 2014 Mar;37[3]:651-8)

Dr. Bill Tettelbach

“There is no straightforward guideline to choose dressing,” said wound care specialist William H. Tettelbach, MD, the medical director of infection prevention, wound care, and antibiotic stewardship at Landmark Hospital in Salt Lake City, in an interview. Instead, he said, there are just some general tenets: Use an absorbing dressing for a wet ulcer, a moist dressing for a dry ulcer, and an antimicrobial dressing for a bacterial ulcer.

The new multi-center, randomized, controlled phase 2/3 study – funded by the biotech company Edixomed – examined the use of a nitric oxide–generating dressing known as EDX110. The dressing consists of a moist mesh and a second layer that keeps the first layer in place.

 

 


“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Edmonds said. “Nitric oxide plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”

Dr. Michael E. Edmonds
Researchers randomly assigned patients with chronic DFUs – including some with infections – to a control group (n = 73) or a treatment group that received the experimental dressing (n = 75). The study protocol was changed partway through to allow patients with DFUs of at least 14 days duration to participate instead of just those with DFUs in place for at least 6 weeks.

The average age of patients in both groups was 59 years, and males made up 82%-87% of the total. Some had more than 1 ulcer.

All patients received standard DFU care for their institution with the exception of members of the treatment group, who were given the EDX110 dressing. Participants were treated for 12 weeks or until their ulcers healed followed by a 12-week follow-up period.
 

 


The institutes used a wide variety of dressings including absorbent pad, alginate, antimicrobial, foam, gauze, and other types. About a third were antimicrobial.

In the intent-to-treat population at 12 weeks, the median percentage area reduction of the ulcers was 89% in the treatment group, compared with 47% in the control group (P = .016).

The researchers reported significantly fewer serious adverse events in the treatment group, and none were reported to be linked to the various dressings used.

According to Dr. Edmonds, pricing information for the treatment is unavailable.

 

 


Dr. Tettelbach cautioned about the limitations of the study. For one, it doesn’t focus on chronic DFUs that can last well beyond a month and “are more problematic to heal and pose a greater relative risk of infection than acute DFUs.”

He added: “Surrogate end points such as 80% reduction in surface area at 12 weeks are difficult to extrapolate to expected closure. An open chronic ulcer is at risk for complicating infection no matter what size,” he said.

Overall, Dr. Tettelbach said, he doesn’t see the study as a “big deal,” but it’s “a welcomed addition to the wound dressing family that works using a novel mechanism of stimulating angiogenesis and antimicrobial properties.”

The biotech company Edixomed funded the study. The study authors report various disclosures or no disclosures; two disclose links to Edixomed.

SOURCE: Edmonds ME et al. Wound Repair Regen. 2018 April 4. doi: 10.1111/wrr.12630.

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Physicians and nurses turn to a wide variety of kinds of dressings to treat patients with diabetic foot ulcers (DFU). Now, new data from an industry-funded study suggest that an experimental nitric oxide-generating dressing holds promise as a tool to reduce diabetic foot wound size in certain cases.

Balkonsky/Thinkstock

The treatment is still in the research stage, and it’s not clear whether more studies will be conducted. For now, though, “we have a topical agent which specifically treats infection as well as increases perfusion of the ulcer,” study lead author Michael E. Edmonds, MD, a professor of diabetes and endocrinology at King’s College Hospital in London, said in an interview. “The study also showed that the agent not only improved healing but significantly reduced serious adverse events related to the ulcer, which included hospitalizations and amputations.”
 

The study appeared online April 4 in Wound Repair and Regeneration.

Researchers estimate that DFUs affect as many as 4% of patients with diabetes each year, with about a quarter developing the condition over their lifetimes.

A 2014 U.S. study found that 4%-5% percentage of patients with DFUs underwent lower limb amputations over a 12-month period. The same study also estimated that DFU-related care costs as much as $13 billion a year. (Diabetes Care. 2014 Mar;37[3]:651-8)

Dr. Bill Tettelbach

“There is no straightforward guideline to choose dressing,” said wound care specialist William H. Tettelbach, MD, the medical director of infection prevention, wound care, and antibiotic stewardship at Landmark Hospital in Salt Lake City, in an interview. Instead, he said, there are just some general tenets: Use an absorbing dressing for a wet ulcer, a moist dressing for a dry ulcer, and an antimicrobial dressing for a bacterial ulcer.

The new multi-center, randomized, controlled phase 2/3 study – funded by the biotech company Edixomed – examined the use of a nitric oxide–generating dressing known as EDX110. The dressing consists of a moist mesh and a second layer that keeps the first layer in place.

 

 


“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Edmonds said. “Nitric oxide plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”

Dr. Michael E. Edmonds
Researchers randomly assigned patients with chronic DFUs – including some with infections – to a control group (n = 73) or a treatment group that received the experimental dressing (n = 75). The study protocol was changed partway through to allow patients with DFUs of at least 14 days duration to participate instead of just those with DFUs in place for at least 6 weeks.

The average age of patients in both groups was 59 years, and males made up 82%-87% of the total. Some had more than 1 ulcer.

All patients received standard DFU care for their institution with the exception of members of the treatment group, who were given the EDX110 dressing. Participants were treated for 12 weeks or until their ulcers healed followed by a 12-week follow-up period.
 

 


The institutes used a wide variety of dressings including absorbent pad, alginate, antimicrobial, foam, gauze, and other types. About a third were antimicrobial.

In the intent-to-treat population at 12 weeks, the median percentage area reduction of the ulcers was 89% in the treatment group, compared with 47% in the control group (P = .016).

The researchers reported significantly fewer serious adverse events in the treatment group, and none were reported to be linked to the various dressings used.

According to Dr. Edmonds, pricing information for the treatment is unavailable.

 

 


Dr. Tettelbach cautioned about the limitations of the study. For one, it doesn’t focus on chronic DFUs that can last well beyond a month and “are more problematic to heal and pose a greater relative risk of infection than acute DFUs.”

He added: “Surrogate end points such as 80% reduction in surface area at 12 weeks are difficult to extrapolate to expected closure. An open chronic ulcer is at risk for complicating infection no matter what size,” he said.

Overall, Dr. Tettelbach said, he doesn’t see the study as a “big deal,” but it’s “a welcomed addition to the wound dressing family that works using a novel mechanism of stimulating angiogenesis and antimicrobial properties.”

The biotech company Edixomed funded the study. The study authors report various disclosures or no disclosures; two disclose links to Edixomed.

SOURCE: Edmonds ME et al. Wound Repair Regen. 2018 April 4. doi: 10.1111/wrr.12630.

 

Physicians and nurses turn to a wide variety of kinds of dressings to treat patients with diabetic foot ulcers (DFU). Now, new data from an industry-funded study suggest that an experimental nitric oxide-generating dressing holds promise as a tool to reduce diabetic foot wound size in certain cases.

Balkonsky/Thinkstock

The treatment is still in the research stage, and it’s not clear whether more studies will be conducted. For now, though, “we have a topical agent which specifically treats infection as well as increases perfusion of the ulcer,” study lead author Michael E. Edmonds, MD, a professor of diabetes and endocrinology at King’s College Hospital in London, said in an interview. “The study also showed that the agent not only improved healing but significantly reduced serious adverse events related to the ulcer, which included hospitalizations and amputations.”
 

The study appeared online April 4 in Wound Repair and Regeneration.

Researchers estimate that DFUs affect as many as 4% of patients with diabetes each year, with about a quarter developing the condition over their lifetimes.

A 2014 U.S. study found that 4%-5% percentage of patients with DFUs underwent lower limb amputations over a 12-month period. The same study also estimated that DFU-related care costs as much as $13 billion a year. (Diabetes Care. 2014 Mar;37[3]:651-8)

Dr. Bill Tettelbach

“There is no straightforward guideline to choose dressing,” said wound care specialist William H. Tettelbach, MD, the medical director of infection prevention, wound care, and antibiotic stewardship at Landmark Hospital in Salt Lake City, in an interview. Instead, he said, there are just some general tenets: Use an absorbing dressing for a wet ulcer, a moist dressing for a dry ulcer, and an antimicrobial dressing for a bacterial ulcer.

The new multi-center, randomized, controlled phase 2/3 study – funded by the biotech company Edixomed – examined the use of a nitric oxide–generating dressing known as EDX110. The dressing consists of a moist mesh and a second layer that keeps the first layer in place.

 

 


“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Edmonds said. “Nitric oxide plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”

Dr. Michael E. Edmonds
Researchers randomly assigned patients with chronic DFUs – including some with infections – to a control group (n = 73) or a treatment group that received the experimental dressing (n = 75). The study protocol was changed partway through to allow patients with DFUs of at least 14 days duration to participate instead of just those with DFUs in place for at least 6 weeks.

The average age of patients in both groups was 59 years, and males made up 82%-87% of the total. Some had more than 1 ulcer.

All patients received standard DFU care for their institution with the exception of members of the treatment group, who were given the EDX110 dressing. Participants were treated for 12 weeks or until their ulcers healed followed by a 12-week follow-up period.
 

 


The institutes used a wide variety of dressings including absorbent pad, alginate, antimicrobial, foam, gauze, and other types. About a third were antimicrobial.

In the intent-to-treat population at 12 weeks, the median percentage area reduction of the ulcers was 89% in the treatment group, compared with 47% in the control group (P = .016).

The researchers reported significantly fewer serious adverse events in the treatment group, and none were reported to be linked to the various dressings used.

According to Dr. Edmonds, pricing information for the treatment is unavailable.

 

 


Dr. Tettelbach cautioned about the limitations of the study. For one, it doesn’t focus on chronic DFUs that can last well beyond a month and “are more problematic to heal and pose a greater relative risk of infection than acute DFUs.”

He added: “Surrogate end points such as 80% reduction in surface area at 12 weeks are difficult to extrapolate to expected closure. An open chronic ulcer is at risk for complicating infection no matter what size,” he said.

Overall, Dr. Tettelbach said, he doesn’t see the study as a “big deal,” but it’s “a welcomed addition to the wound dressing family that works using a novel mechanism of stimulating angiogenesis and antimicrobial properties.”

The biotech company Edixomed funded the study. The study authors report various disclosures or no disclosures; two disclose links to Edixomed.

SOURCE: Edmonds ME et al. Wound Repair Regen. 2018 April 4. doi: 10.1111/wrr.12630.

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FDA approves new drug for thrombocytopenia

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Fostamatinib disodium hexahydrate (Tavalisse) is now approved as a second-line treatment for thrombocytopenia in adults with chronic immune thrombocytopenia (ITP).

The Food and Drug Administration approved the oral spleen tyrosine kinase (SYK) inhibitor, which works by impeding platelet destruction, on April 17. Its approval was based on data from FIT clinical program, including two randomized placebo-controlled phase 3 trials.

Courtesy Rigel Pharmaceuticals
Fostamatinib (Tavalisse) was approved in April 2018.
The drug’s prescribing information calls for starting fostamatinib at 100 mg orally twice daily with or without food and increasing to 150 mg twice daily after 4 weeks, if needed, to achieve platelet counts of at least 50 x 109/L. Fostamatinib should be discontinued after 12 weeks if the platelet count does not increase enough to avoid clinically important bleeding.

Physicians are advised to monitor blood pressure and liver function with the drug. Fostamatinib may interact with CYP3A4 inhibitors and inducers. Concomitant use of fostamatinib with CYP3A4 inhibitors increases exposure to R406 – the drug’s major metabolite – and may increase the risk of adverse reactions. Use with strong CYP3A4 inducers is not recommended because it reduces exposure to R406.

Women of reproductive potential should be advised to use appropriate contraception while using fostamatinib and for a month after stopping the drug; pregnant women should be told of potential risk to the fetus. Advise women not to breastfeed during treatment and for at least 1 month after the last dose, according to a press statement.

Rigel Pharmaceuticals plans to release the drug in the United States in late May 2018.
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Fostamatinib disodium hexahydrate (Tavalisse) is now approved as a second-line treatment for thrombocytopenia in adults with chronic immune thrombocytopenia (ITP).

The Food and Drug Administration approved the oral spleen tyrosine kinase (SYK) inhibitor, which works by impeding platelet destruction, on April 17. Its approval was based on data from FIT clinical program, including two randomized placebo-controlled phase 3 trials.

Courtesy Rigel Pharmaceuticals
Fostamatinib (Tavalisse) was approved in April 2018.
The drug’s prescribing information calls for starting fostamatinib at 100 mg orally twice daily with or without food and increasing to 150 mg twice daily after 4 weeks, if needed, to achieve platelet counts of at least 50 x 109/L. Fostamatinib should be discontinued after 12 weeks if the platelet count does not increase enough to avoid clinically important bleeding.

Physicians are advised to monitor blood pressure and liver function with the drug. Fostamatinib may interact with CYP3A4 inhibitors and inducers. Concomitant use of fostamatinib with CYP3A4 inhibitors increases exposure to R406 – the drug’s major metabolite – and may increase the risk of adverse reactions. Use with strong CYP3A4 inducers is not recommended because it reduces exposure to R406.

Women of reproductive potential should be advised to use appropriate contraception while using fostamatinib and for a month after stopping the drug; pregnant women should be told of potential risk to the fetus. Advise women not to breastfeed during treatment and for at least 1 month after the last dose, according to a press statement.

Rigel Pharmaceuticals plans to release the drug in the United States in late May 2018.

 

Fostamatinib disodium hexahydrate (Tavalisse) is now approved as a second-line treatment for thrombocytopenia in adults with chronic immune thrombocytopenia (ITP).

The Food and Drug Administration approved the oral spleen tyrosine kinase (SYK) inhibitor, which works by impeding platelet destruction, on April 17. Its approval was based on data from FIT clinical program, including two randomized placebo-controlled phase 3 trials.

Courtesy Rigel Pharmaceuticals
Fostamatinib (Tavalisse) was approved in April 2018.
The drug’s prescribing information calls for starting fostamatinib at 100 mg orally twice daily with or without food and increasing to 150 mg twice daily after 4 weeks, if needed, to achieve platelet counts of at least 50 x 109/L. Fostamatinib should be discontinued after 12 weeks if the platelet count does not increase enough to avoid clinically important bleeding.

Physicians are advised to monitor blood pressure and liver function with the drug. Fostamatinib may interact with CYP3A4 inhibitors and inducers. Concomitant use of fostamatinib with CYP3A4 inhibitors increases exposure to R406 – the drug’s major metabolite – and may increase the risk of adverse reactions. Use with strong CYP3A4 inducers is not recommended because it reduces exposure to R406.

Women of reproductive potential should be advised to use appropriate contraception while using fostamatinib and for a month after stopping the drug; pregnant women should be told of potential risk to the fetus. Advise women not to breastfeed during treatment and for at least 1 month after the last dose, according to a press statement.

Rigel Pharmaceuticals plans to release the drug in the United States in late May 2018.
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Clinical Guidelines: Testosterone therapy in men with hypogonadism

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Guidelines issued jointly by the Endocrine Society and the European Society for Endocrinology provide clinicians with a clear consensus approach to male hypogonadism, commonly referred to by patients as “low T.” Hypogonadism results from “the failure of the testes to produce physiological concentrations of testosterone and/or a normal number of spermatozoa due to pathology at one or more levels of the hypothalamic-pituitary-testicular axis,” according to the definition that serves as the basis for the guidelines.

Dr. Neil Skolnik (left) and Dr. Michael Hurchick
Primary hypogonadism is caused by abnormalities at the testicular level, and secondary hypogonadism is caused by a defect of the hypothalamic pituitary axis. The two can be distinguished by elevated gonadotropin levels (LH and FSH) in primary hypogonadism, which rise in response to low testosterone levels. In secondary hypogonadism, gonadotropin levels are low or inappropriately normal. Causes of secondary hypogonadism include hyperprolactinemia, severe obesity, iron overload syndromes, opioid use, glucocorticoids, or androgen-deprivation therapy, androgenic-anabolic steroid withdrawal syndrome, idiopathic hypogonadotropic hypogonadism, hypothalamic or pituitary tumors or infiltrative disease, head trauma, and pituitary surgery or irradiation.

The causes of hypogonadism can also be divided into irreversible and reversible disorders. Irreversible disorders include congenital, structural, or destructive disorders that lead to permanent organ dysfunction. Reversible hypogonadism includes causes, such as obesity, opioids, or systemic illness, that can suppress gonadotropin and testosterone concentrations but that may be reversible.
 

Diagnosis

The signs and symptoms of hypogonadism are often nonspecific and include decreased energy, depressed mood, poor concentration and memory, sleep disturbance, mild normocytic normochromic anemia, reduced muscle bulk and strength, increased body fat, reduced libido, decreased erections, gynecomastia, low-trauma fractures, and loss of body hair. The diagnosis of hypogonadism is made when there are signs and symptoms of testosterone deficiency and of unequivocally and consistently low serum total testosterone and/or free testosterone concentrations.

Serum testosterone concentrations have diurnal variations, with values peaking in the morning. In addition, food intake suppresses testosterone concentrations. Therefore, testosterone levels should be measured in the morning after an overnight fast. Low testosterone concentrations need to be confirmed before making the diagnosis of hypogonadism because 30% of men with an initial testosterone concentration in the hypogonadal range have a normal testosterone concentration on repeat measurement. In addition, testosterone concentrations are not accurate in patients recovering from acute illness or taking medications known to suppress testosterone.

Testing of free testosterone and sex hormone–binding globulin (SHBG) may be considered in patients at risk for increased or decreased SHBG, including the obese, men with diabetes, the elderly, those with HIV or liver disease, or those taking estrogens and medications that may affect SHBG.

In individuals with low testosterone levels, a serum FSH and LH should be ordered to differentiate primary from secondary hypogonadism. Middle-aged and older men with secondary hypogonadism have a low prevalence of hypothalamic/pituitary abnormalities.

 

 

Treatment

In patients found to have low testosterone with signs and symptoms of testosterone deficiency, testosterone therapy is recommended to induce and maintain secondary sex characteristics and correct the symptoms of testosterone deficiency. Testosterone-replacement therapy in men with low testosterone levels leads to a small but statistically significant improvement in libido, erectile function, sexual activity or satisfaction, muscle mass, and bone density but does not lead to improvements in energy and mood.

Testosterone replacement should not be done in patient’s planning fertility in the near future, those with prostate or breast cancer, a palpable prostate nodule, a prostate-specific antigen (PSA) level greater than 4 ng/mL, a PSA greater than 3 ng/mL with high risk for prostate cancer, high hematocrit, untreated obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, MI or stroke within the last 6 months, or thrombophilia.

In men undergoing therapy, there is a higher frequency of erythrocytosis (hematocrit greater than 54%; relative risk, 8.14) but no increase in lower urinary tract symptoms. The benefit and risk of regular prostate cancer screening should be discussed prior to starting therapy with men aged 40-69 years with an increased risk of prostate cancer and with all men aged 55-69 years. For those who desire prostate cancer screening, PSA levels should be checked prior to starting therapy, and a digital prostate examination should be done at baseline and at 3-12 months after starting testosterone treatment. After 1 year, prostate cancer screening can be done per standard guidelines.

The decision about therapy in men older than 65 years is challenging because testosterone levels normally decline with age. It is not necessary to prescribe testosterone routinely to men older than 65 years with only low testosterone, and treatment should be reserved for those with symptoms along with low testosterone concentrations.

Men with HIV with low testosterone concentrations and weight loss can be treated with testosterone to induce and maintain body weight and lean muscle mass.
 

 

 

Monitoring

Patients should be evaluated 3-6 months after initiating treatment to see whether symptoms have improved, to see whether there have been adverse reactions, and to check labs.

Serum testosterone should be checked and the dose of testosterone replacement should be adjusted to maintain the serum testosterone level in the mid-normal range for healthy young men. Serum testosterone should be drawn at different times for different formulations – for instance, it should be checked 2-8 hours following a gel application.

Hematocrit should be checked at baseline and 3-6 months into treatment. If hematocrit is greater than 54%, therapy should be held until hematocrit decreases and then restarted at a reduced dose. Screening for prostate cancer should be done if that was decided upon during discussion with the patient. Further urologic evaluation is indicated in men who, during the first year of treatment, develop an increase from baseline PSA greater than 1.4 ng/mL, have a repeat PSA over 4 ng/mL, or have a prostatic abnormality on digital rectal exam.

The bottom line

Hypogonadism is common and presents diagnostic challenges because of nonspecific signs and symptoms. Serum testosterone should be checked on a first-morning fasting specimen. Low testosterone concentrations need to be confirmed before making the diagnosis and should be followed by checking FSH and LH. For those with signs and symptoms of hypogonadism and persistently low testosterone, testosterone replacement therapy can be beneficial, with a goal of maintaining serum testosterone in the mid-range of normal.

Reference

Bhasin S et al. Testosterone therapy in men with hypogonadism: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018 May;103(5):1-30.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Hurchick is a third-year resident in the family medicine residency program at Abington Jefferson Health.

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Guidelines issued jointly by the Endocrine Society and the European Society for Endocrinology provide clinicians with a clear consensus approach to male hypogonadism, commonly referred to by patients as “low T.” Hypogonadism results from “the failure of the testes to produce physiological concentrations of testosterone and/or a normal number of spermatozoa due to pathology at one or more levels of the hypothalamic-pituitary-testicular axis,” according to the definition that serves as the basis for the guidelines.

Dr. Neil Skolnik (left) and Dr. Michael Hurchick
Primary hypogonadism is caused by abnormalities at the testicular level, and secondary hypogonadism is caused by a defect of the hypothalamic pituitary axis. The two can be distinguished by elevated gonadotropin levels (LH and FSH) in primary hypogonadism, which rise in response to low testosterone levels. In secondary hypogonadism, gonadotropin levels are low or inappropriately normal. Causes of secondary hypogonadism include hyperprolactinemia, severe obesity, iron overload syndromes, opioid use, glucocorticoids, or androgen-deprivation therapy, androgenic-anabolic steroid withdrawal syndrome, idiopathic hypogonadotropic hypogonadism, hypothalamic or pituitary tumors or infiltrative disease, head trauma, and pituitary surgery or irradiation.

The causes of hypogonadism can also be divided into irreversible and reversible disorders. Irreversible disorders include congenital, structural, or destructive disorders that lead to permanent organ dysfunction. Reversible hypogonadism includes causes, such as obesity, opioids, or systemic illness, that can suppress gonadotropin and testosterone concentrations but that may be reversible.
 

Diagnosis

The signs and symptoms of hypogonadism are often nonspecific and include decreased energy, depressed mood, poor concentration and memory, sleep disturbance, mild normocytic normochromic anemia, reduced muscle bulk and strength, increased body fat, reduced libido, decreased erections, gynecomastia, low-trauma fractures, and loss of body hair. The diagnosis of hypogonadism is made when there are signs and symptoms of testosterone deficiency and of unequivocally and consistently low serum total testosterone and/or free testosterone concentrations.

Serum testosterone concentrations have diurnal variations, with values peaking in the morning. In addition, food intake suppresses testosterone concentrations. Therefore, testosterone levels should be measured in the morning after an overnight fast. Low testosterone concentrations need to be confirmed before making the diagnosis of hypogonadism because 30% of men with an initial testosterone concentration in the hypogonadal range have a normal testosterone concentration on repeat measurement. In addition, testosterone concentrations are not accurate in patients recovering from acute illness or taking medications known to suppress testosterone.

Testing of free testosterone and sex hormone–binding globulin (SHBG) may be considered in patients at risk for increased or decreased SHBG, including the obese, men with diabetes, the elderly, those with HIV or liver disease, or those taking estrogens and medications that may affect SHBG.

In individuals with low testosterone levels, a serum FSH and LH should be ordered to differentiate primary from secondary hypogonadism. Middle-aged and older men with secondary hypogonadism have a low prevalence of hypothalamic/pituitary abnormalities.

 

 

Treatment

In patients found to have low testosterone with signs and symptoms of testosterone deficiency, testosterone therapy is recommended to induce and maintain secondary sex characteristics and correct the symptoms of testosterone deficiency. Testosterone-replacement therapy in men with low testosterone levels leads to a small but statistically significant improvement in libido, erectile function, sexual activity or satisfaction, muscle mass, and bone density but does not lead to improvements in energy and mood.

Testosterone replacement should not be done in patient’s planning fertility in the near future, those with prostate or breast cancer, a palpable prostate nodule, a prostate-specific antigen (PSA) level greater than 4 ng/mL, a PSA greater than 3 ng/mL with high risk for prostate cancer, high hematocrit, untreated obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, MI or stroke within the last 6 months, or thrombophilia.

In men undergoing therapy, there is a higher frequency of erythrocytosis (hematocrit greater than 54%; relative risk, 8.14) but no increase in lower urinary tract symptoms. The benefit and risk of regular prostate cancer screening should be discussed prior to starting therapy with men aged 40-69 years with an increased risk of prostate cancer and with all men aged 55-69 years. For those who desire prostate cancer screening, PSA levels should be checked prior to starting therapy, and a digital prostate examination should be done at baseline and at 3-12 months after starting testosterone treatment. After 1 year, prostate cancer screening can be done per standard guidelines.

The decision about therapy in men older than 65 years is challenging because testosterone levels normally decline with age. It is not necessary to prescribe testosterone routinely to men older than 65 years with only low testosterone, and treatment should be reserved for those with symptoms along with low testosterone concentrations.

Men with HIV with low testosterone concentrations and weight loss can be treated with testosterone to induce and maintain body weight and lean muscle mass.
 

 

 

Monitoring

Patients should be evaluated 3-6 months after initiating treatment to see whether symptoms have improved, to see whether there have been adverse reactions, and to check labs.

Serum testosterone should be checked and the dose of testosterone replacement should be adjusted to maintain the serum testosterone level in the mid-normal range for healthy young men. Serum testosterone should be drawn at different times for different formulations – for instance, it should be checked 2-8 hours following a gel application.

Hematocrit should be checked at baseline and 3-6 months into treatment. If hematocrit is greater than 54%, therapy should be held until hematocrit decreases and then restarted at a reduced dose. Screening for prostate cancer should be done if that was decided upon during discussion with the patient. Further urologic evaluation is indicated in men who, during the first year of treatment, develop an increase from baseline PSA greater than 1.4 ng/mL, have a repeat PSA over 4 ng/mL, or have a prostatic abnormality on digital rectal exam.

The bottom line

Hypogonadism is common and presents diagnostic challenges because of nonspecific signs and symptoms. Serum testosterone should be checked on a first-morning fasting specimen. Low testosterone concentrations need to be confirmed before making the diagnosis and should be followed by checking FSH and LH. For those with signs and symptoms of hypogonadism and persistently low testosterone, testosterone replacement therapy can be beneficial, with a goal of maintaining serum testosterone in the mid-range of normal.

Reference

Bhasin S et al. Testosterone therapy in men with hypogonadism: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018 May;103(5):1-30.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Hurchick is a third-year resident in the family medicine residency program at Abington Jefferson Health.

 

Guidelines issued jointly by the Endocrine Society and the European Society for Endocrinology provide clinicians with a clear consensus approach to male hypogonadism, commonly referred to by patients as “low T.” Hypogonadism results from “the failure of the testes to produce physiological concentrations of testosterone and/or a normal number of spermatozoa due to pathology at one or more levels of the hypothalamic-pituitary-testicular axis,” according to the definition that serves as the basis for the guidelines.

Dr. Neil Skolnik (left) and Dr. Michael Hurchick
Primary hypogonadism is caused by abnormalities at the testicular level, and secondary hypogonadism is caused by a defect of the hypothalamic pituitary axis. The two can be distinguished by elevated gonadotropin levels (LH and FSH) in primary hypogonadism, which rise in response to low testosterone levels. In secondary hypogonadism, gonadotropin levels are low or inappropriately normal. Causes of secondary hypogonadism include hyperprolactinemia, severe obesity, iron overload syndromes, opioid use, glucocorticoids, or androgen-deprivation therapy, androgenic-anabolic steroid withdrawal syndrome, idiopathic hypogonadotropic hypogonadism, hypothalamic or pituitary tumors or infiltrative disease, head trauma, and pituitary surgery or irradiation.

The causes of hypogonadism can also be divided into irreversible and reversible disorders. Irreversible disorders include congenital, structural, or destructive disorders that lead to permanent organ dysfunction. Reversible hypogonadism includes causes, such as obesity, opioids, or systemic illness, that can suppress gonadotropin and testosterone concentrations but that may be reversible.
 

Diagnosis

The signs and symptoms of hypogonadism are often nonspecific and include decreased energy, depressed mood, poor concentration and memory, sleep disturbance, mild normocytic normochromic anemia, reduced muscle bulk and strength, increased body fat, reduced libido, decreased erections, gynecomastia, low-trauma fractures, and loss of body hair. The diagnosis of hypogonadism is made when there are signs and symptoms of testosterone deficiency and of unequivocally and consistently low serum total testosterone and/or free testosterone concentrations.

Serum testosterone concentrations have diurnal variations, with values peaking in the morning. In addition, food intake suppresses testosterone concentrations. Therefore, testosterone levels should be measured in the morning after an overnight fast. Low testosterone concentrations need to be confirmed before making the diagnosis of hypogonadism because 30% of men with an initial testosterone concentration in the hypogonadal range have a normal testosterone concentration on repeat measurement. In addition, testosterone concentrations are not accurate in patients recovering from acute illness or taking medications known to suppress testosterone.

Testing of free testosterone and sex hormone–binding globulin (SHBG) may be considered in patients at risk for increased or decreased SHBG, including the obese, men with diabetes, the elderly, those with HIV or liver disease, or those taking estrogens and medications that may affect SHBG.

In individuals with low testosterone levels, a serum FSH and LH should be ordered to differentiate primary from secondary hypogonadism. Middle-aged and older men with secondary hypogonadism have a low prevalence of hypothalamic/pituitary abnormalities.

 

 

Treatment

In patients found to have low testosterone with signs and symptoms of testosterone deficiency, testosterone therapy is recommended to induce and maintain secondary sex characteristics and correct the symptoms of testosterone deficiency. Testosterone-replacement therapy in men with low testosterone levels leads to a small but statistically significant improvement in libido, erectile function, sexual activity or satisfaction, muscle mass, and bone density but does not lead to improvements in energy and mood.

Testosterone replacement should not be done in patient’s planning fertility in the near future, those with prostate or breast cancer, a palpable prostate nodule, a prostate-specific antigen (PSA) level greater than 4 ng/mL, a PSA greater than 3 ng/mL with high risk for prostate cancer, high hematocrit, untreated obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, MI or stroke within the last 6 months, or thrombophilia.

In men undergoing therapy, there is a higher frequency of erythrocytosis (hematocrit greater than 54%; relative risk, 8.14) but no increase in lower urinary tract symptoms. The benefit and risk of regular prostate cancer screening should be discussed prior to starting therapy with men aged 40-69 years with an increased risk of prostate cancer and with all men aged 55-69 years. For those who desire prostate cancer screening, PSA levels should be checked prior to starting therapy, and a digital prostate examination should be done at baseline and at 3-12 months after starting testosterone treatment. After 1 year, prostate cancer screening can be done per standard guidelines.

The decision about therapy in men older than 65 years is challenging because testosterone levels normally decline with age. It is not necessary to prescribe testosterone routinely to men older than 65 years with only low testosterone, and treatment should be reserved for those with symptoms along with low testosterone concentrations.

Men with HIV with low testosterone concentrations and weight loss can be treated with testosterone to induce and maintain body weight and lean muscle mass.
 

 

 

Monitoring

Patients should be evaluated 3-6 months after initiating treatment to see whether symptoms have improved, to see whether there have been adverse reactions, and to check labs.

Serum testosterone should be checked and the dose of testosterone replacement should be adjusted to maintain the serum testosterone level in the mid-normal range for healthy young men. Serum testosterone should be drawn at different times for different formulations – for instance, it should be checked 2-8 hours following a gel application.

Hematocrit should be checked at baseline and 3-6 months into treatment. If hematocrit is greater than 54%, therapy should be held until hematocrit decreases and then restarted at a reduced dose. Screening for prostate cancer should be done if that was decided upon during discussion with the patient. Further urologic evaluation is indicated in men who, during the first year of treatment, develop an increase from baseline PSA greater than 1.4 ng/mL, have a repeat PSA over 4 ng/mL, or have a prostatic abnormality on digital rectal exam.

The bottom line

Hypogonadism is common and presents diagnostic challenges because of nonspecific signs and symptoms. Serum testosterone should be checked on a first-morning fasting specimen. Low testosterone concentrations need to be confirmed before making the diagnosis and should be followed by checking FSH and LH. For those with signs and symptoms of hypogonadism and persistently low testosterone, testosterone replacement therapy can be beneficial, with a goal of maintaining serum testosterone in the mid-range of normal.

Reference

Bhasin S et al. Testosterone therapy in men with hypogonadism: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018 May;103(5):1-30.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Hurchick is a third-year resident in the family medicine residency program at Abington Jefferson Health.

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What does burnout cost?

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How are you feeling today? Simple words but a bit of introspection can go a long way. Physician burnout is characterized by a state of mental exhaustion, depersonalization, and a decreased sense of accomplishment. It affects a physician’s well-being, effectiveness, productivity, and the ability to provide quality care. It also carries personal consequences for physicians including broken relationships, substance abuse, suicide, and depression.

Burnout may affect at least one-third of gastroenterologists. At greater risk are younger physicians, physicians performing high-risk procedures, and physicians experiencing work-life conflicts.

While the root cause of physician burnout varies from provider to provider, an overarching theme is work stress. Work stress may develop for a number of reasons, including issues at the level of the health care system (shifts in reimbursement or payment models, increasing clerical burden of the electronic medical record), organizational issues (e.g., dysfunctional administration, system-wide communication issues), and personal issues.

The key to preventing burnout is to first recognize that it can happen. Because initial symptoms build up internally, it can be easy to overlook. These seven steps can help you prevent burnout:

  •  Be self-aware and stay vigilant.
  •  Take care of yourself first.
  •  Stay connected to family, friends, and coworkers.
  •  Exercise.
  •  Ensure adequate sleep.
  •  Use your vacation time and ensure you disconnect yourself from work.
  •  Learn to say no.

A case study published in Clinical Gastroenterology and Hepatology delves deeper into how burnout develops, why it matters, and provides pathways to successfully combat it.
 

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How are you feeling today? Simple words but a bit of introspection can go a long way. Physician burnout is characterized by a state of mental exhaustion, depersonalization, and a decreased sense of accomplishment. It affects a physician’s well-being, effectiveness, productivity, and the ability to provide quality care. It also carries personal consequences for physicians including broken relationships, substance abuse, suicide, and depression.

Burnout may affect at least one-third of gastroenterologists. At greater risk are younger physicians, physicians performing high-risk procedures, and physicians experiencing work-life conflicts.

While the root cause of physician burnout varies from provider to provider, an overarching theme is work stress. Work stress may develop for a number of reasons, including issues at the level of the health care system (shifts in reimbursement or payment models, increasing clerical burden of the electronic medical record), organizational issues (e.g., dysfunctional administration, system-wide communication issues), and personal issues.

The key to preventing burnout is to first recognize that it can happen. Because initial symptoms build up internally, it can be easy to overlook. These seven steps can help you prevent burnout:

  •  Be self-aware and stay vigilant.
  •  Take care of yourself first.
  •  Stay connected to family, friends, and coworkers.
  •  Exercise.
  •  Ensure adequate sleep.
  •  Use your vacation time and ensure you disconnect yourself from work.
  •  Learn to say no.

A case study published in Clinical Gastroenterology and Hepatology delves deeper into how burnout develops, why it matters, and provides pathways to successfully combat it.
 

 

How are you feeling today? Simple words but a bit of introspection can go a long way. Physician burnout is characterized by a state of mental exhaustion, depersonalization, and a decreased sense of accomplishment. It affects a physician’s well-being, effectiveness, productivity, and the ability to provide quality care. It also carries personal consequences for physicians including broken relationships, substance abuse, suicide, and depression.

Burnout may affect at least one-third of gastroenterologists. At greater risk are younger physicians, physicians performing high-risk procedures, and physicians experiencing work-life conflicts.

While the root cause of physician burnout varies from provider to provider, an overarching theme is work stress. Work stress may develop for a number of reasons, including issues at the level of the health care system (shifts in reimbursement or payment models, increasing clerical burden of the electronic medical record), organizational issues (e.g., dysfunctional administration, system-wide communication issues), and personal issues.

The key to preventing burnout is to first recognize that it can happen. Because initial symptoms build up internally, it can be easy to overlook. These seven steps can help you prevent burnout:

  •  Be self-aware and stay vigilant.
  •  Take care of yourself first.
  •  Stay connected to family, friends, and coworkers.
  •  Exercise.
  •  Ensure adequate sleep.
  •  Use your vacation time and ensure you disconnect yourself from work.
  •  Learn to say no.

A case study published in Clinical Gastroenterology and Hepatology delves deeper into how burnout develops, why it matters, and provides pathways to successfully combat it.
 

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Sessions at DDW® 2018 designed for trainees and early career GIs

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AGA has developed special sessions at Digestive Disease Week® (DDW) 2018 to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.

With the exception of the AGA Postgraduate Course, all of the sessions are free, but you must register for DDW to attend. Registration is open and is complimentary for AGA member trainees, students, medical residents, and postdoctoral fellows until April 18. Visit the AGA website for additional details about these sessions.

Saturday, June 2, and Sunday, June 3

  •  Difficult Conversations: Navigating People, Negotiations, Promotions, and Complications

Sunday, June 3, 4-5:30 p.m.

  •  Advancing Clinical Practice: GI Fellow-Directed Quality Improvement Projects

Monday, June 4, 4-5:30 p.m.

  •  Board Review Course

Tuesday, June 5, 1:30-5:30 p.m.
 

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AGA has developed special sessions at Digestive Disease Week® (DDW) 2018 to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.

With the exception of the AGA Postgraduate Course, all of the sessions are free, but you must register for DDW to attend. Registration is open and is complimentary for AGA member trainees, students, medical residents, and postdoctoral fellows until April 18. Visit the AGA website for additional details about these sessions.

Saturday, June 2, and Sunday, June 3

  •  Difficult Conversations: Navigating People, Negotiations, Promotions, and Complications

Sunday, June 3, 4-5:30 p.m.

  •  Advancing Clinical Practice: GI Fellow-Directed Quality Improvement Projects

Monday, June 4, 4-5:30 p.m.

  •  Board Review Course

Tuesday, June 5, 1:30-5:30 p.m.
 

AGA has developed special sessions at Digestive Disease Week® (DDW) 2018 to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.

With the exception of the AGA Postgraduate Course, all of the sessions are free, but you must register for DDW to attend. Registration is open and is complimentary for AGA member trainees, students, medical residents, and postdoctoral fellows until April 18. Visit the AGA website for additional details about these sessions.

Saturday, June 2, and Sunday, June 3

  •  Difficult Conversations: Navigating People, Negotiations, Promotions, and Complications

Sunday, June 3, 4-5:30 p.m.

  •  Advancing Clinical Practice: GI Fellow-Directed Quality Improvement Projects

Monday, June 4, 4-5:30 p.m.

  •  Board Review Course

Tuesday, June 5, 1:30-5:30 p.m.
 

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Making the most of your DDW experience

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It’s that time of the year again: Digestive Disease Week (DDW®)! This event evolved out of the AGA annual meetings and was first advertised as DDW in the January 1969 issue of Gastroenterology.1 Since that time, it has grown into a truly international event with over 14,000 attendees, 41% of whom attend from abroad.2

DDW is a collaborative event that is jointly sponsored by four professional GI/hepatology-related societies – the AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract. The conference topics cover the gamut of GI and hepatology conditions and participants represent all types of professional settings, including private practice (37%), hospitals (33%), and academic medical centers (28%).2 Whether you’re a first-time attendee or a seasoned participant, DDW offers something for everyone. Below are some tips on how to maximize the benefits of your attendance:
 

Plan ahead

Is there a new treatment or condition you’ve wanted to learn more about? Are you interested in testing the latest endoscopic devices or learning a new procedural technique? Experts from around the world come to DDW to showcase the latest developments in GI. However, with over 5,000 abstracts and lectures and almost 300 exhibition booths, it’s easy to feel overwhelmed by all the offerings. To make the most of your experience, plan ahead.

In the months prior to the conference, visit the DDW website to download the Preliminary Program. Pick out your can’t-miss lectures and events, and put them on your calendar right away. As DDW approaches, invitations from colleagues, societies, and industry grow, so preplanning is a necessity.

Approximately 1 month before DDW, the DDW Mobile App will become available for free download in the Apple and Google Play stores. You can highlight events of interest and place them on a personalized calendar. Allow for push notifications to get the latest updates and schedule changes throughout the event. In addition, the in-app maps of the venue are a fantastic way to locate where scheduled events will take place. Try to attend talks that are located close to one another. The conference center is expansive and you may miss your intended presentations by trying to catch overlapping sessions situated far from each other. If you prefer planning on a desktop or laptop, use the DDW Online Planner (available mid-April) to create your schedule. The information can then be synced to your mobile device through the app.

Upon arrival, be sure to pick up your attendee conference bag. Before recycling the contents, look for any product theaters, satellite symposia, exhibitor booths, or other advertised activities you may want to add to your schedule.

 

 

Practical tips

a) Register ahead of time and pick up your conference bag during off-hours to avoid long lines.

b) Book your hotel early. Most have generous cancellation policies. Registration is required before booking housing.

c) Pack comfortable shoes and dress in layers to accommodate both unpredictable weather and indoor climate control.

Make new connections and nurture old ones

Is your professional hero giving a talk? Are you looking to land your first job or make a move? Do you need some face time with a mentor outside your institution? DDW is a wonderful opportunity to connect with advisers and possible employers as well as potential and established collaborators. Schedules fill up quickly though, so try your best to email requests for meetings well ahead of time. The app also has a messaging feature you can use to communicate with other attendees.

At the meeting, be an active participant and ask questions. One of the greatest benefits of attending the conference is the opportunity to interact with others. For trainees and early career attendees, DDW is your debutante ball! Introduce yourself and your work to the broader GI community. Bring your business cards as well as a notebook to write down questions and comments about your study. Look engaging when standing by your poster and offer to walk visitors through your research. There will also be an opportunity to have free headshots taken in the Early Career area this year.

Also take advantage of DDW’s big draw to reconnect with old friends and colleagues from around the U.S. and the world. Schedule a time to catch up and swap stories. Learn from each other’s successes and mistakes. It’s good for the soul and your career.
 

Post-DDW

Attending DDW is only the start! The most important part of the conference is what happens afterward. Send an email to individuals you met to establish a line of communication and thank them for their advice or insight. Did someone offer to share a protocol, start a collaboration, or introduce you to a colleague? Take them up on the offer! Notes that were taken in the app can also be emailed. In addition, registration includes 2 years of access to DDW On Demand, an online library of sessions. If there were any nonticketed presentations that you missed, you can watch them upon your return. Similarly, access missed posters at the DDW ePosters archive, where you can read poster abstracts and view ePosters, if submitted. Abstracts will still be viewable through the app and online planner as well. Reach out to colleagues if you have questions about their work!

Also, don’t forget to take what you learned back to your community. Share your new knowledge with your colleagues and trainees, and consider if there are any new concepts or approaches that should be implemented in your practice.

 

 

Practical tip

Before it falls off your radar, submit for CME credits for the sessions you attended. To claim CME, you may flag sessions for CME using the DDW Mobile App, visit a CME kiosk on site or access the DDW CME Claim Site after the meeting. Visit the DDW website for more information on claiming CME.

Dr. Lea Ann Chen

Refine, refocus, and recharge

DDW is the most comprehensive GI event in the world. Take advantage of the learning opportunities to improve your own work. Note how the landscape of GI is evolving and use it to reevaluate your own career development strategy and how you want to contribute to the field. Most importantly, get inspired. After exploring the most up-to-date advances and connecting with colleagues and thought leaders at DDW, you will hopefully return to your home institution feeling reinvigorated, refreshed, and ready to apply your newfound insights to your patient care or to your research.

See you at DDW!
 

References

1. Notices. Gastroenterology. 1969;569(1):188-9. http://www.gastrojournal.org/article/S0016-5085(69)80085-5/pdf.

2. Exhibitor Prospectus | Digestive Disease Week® 2018. https://higherlogicdownload.s3.amazonaws.com/GASTRO/44b1f1fd-aaed-44c8-954f-b0eaea6b0462/UploadedFiles/B4KUryNTNS5lEaFk6jBQ_DDW%202018%20Exhibitor%20Prospectus_Staffchanges.pdf

Dr. Chen is assistant professor of medicine, New York University School of Medicine.

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It’s that time of the year again: Digestive Disease Week (DDW®)! This event evolved out of the AGA annual meetings and was first advertised as DDW in the January 1969 issue of Gastroenterology.1 Since that time, it has grown into a truly international event with over 14,000 attendees, 41% of whom attend from abroad.2

DDW is a collaborative event that is jointly sponsored by four professional GI/hepatology-related societies – the AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract. The conference topics cover the gamut of GI and hepatology conditions and participants represent all types of professional settings, including private practice (37%), hospitals (33%), and academic medical centers (28%).2 Whether you’re a first-time attendee or a seasoned participant, DDW offers something for everyone. Below are some tips on how to maximize the benefits of your attendance:
 

Plan ahead

Is there a new treatment or condition you’ve wanted to learn more about? Are you interested in testing the latest endoscopic devices or learning a new procedural technique? Experts from around the world come to DDW to showcase the latest developments in GI. However, with over 5,000 abstracts and lectures and almost 300 exhibition booths, it’s easy to feel overwhelmed by all the offerings. To make the most of your experience, plan ahead.

In the months prior to the conference, visit the DDW website to download the Preliminary Program. Pick out your can’t-miss lectures and events, and put them on your calendar right away. As DDW approaches, invitations from colleagues, societies, and industry grow, so preplanning is a necessity.

Approximately 1 month before DDW, the DDW Mobile App will become available for free download in the Apple and Google Play stores. You can highlight events of interest and place them on a personalized calendar. Allow for push notifications to get the latest updates and schedule changes throughout the event. In addition, the in-app maps of the venue are a fantastic way to locate where scheduled events will take place. Try to attend talks that are located close to one another. The conference center is expansive and you may miss your intended presentations by trying to catch overlapping sessions situated far from each other. If you prefer planning on a desktop or laptop, use the DDW Online Planner (available mid-April) to create your schedule. The information can then be synced to your mobile device through the app.

Upon arrival, be sure to pick up your attendee conference bag. Before recycling the contents, look for any product theaters, satellite symposia, exhibitor booths, or other advertised activities you may want to add to your schedule.

 

 

Practical tips

a) Register ahead of time and pick up your conference bag during off-hours to avoid long lines.

b) Book your hotel early. Most have generous cancellation policies. Registration is required before booking housing.

c) Pack comfortable shoes and dress in layers to accommodate both unpredictable weather and indoor climate control.

Make new connections and nurture old ones

Is your professional hero giving a talk? Are you looking to land your first job or make a move? Do you need some face time with a mentor outside your institution? DDW is a wonderful opportunity to connect with advisers and possible employers as well as potential and established collaborators. Schedules fill up quickly though, so try your best to email requests for meetings well ahead of time. The app also has a messaging feature you can use to communicate with other attendees.

At the meeting, be an active participant and ask questions. One of the greatest benefits of attending the conference is the opportunity to interact with others. For trainees and early career attendees, DDW is your debutante ball! Introduce yourself and your work to the broader GI community. Bring your business cards as well as a notebook to write down questions and comments about your study. Look engaging when standing by your poster and offer to walk visitors through your research. There will also be an opportunity to have free headshots taken in the Early Career area this year.

Also take advantage of DDW’s big draw to reconnect with old friends and colleagues from around the U.S. and the world. Schedule a time to catch up and swap stories. Learn from each other’s successes and mistakes. It’s good for the soul and your career.
 

Post-DDW

Attending DDW is only the start! The most important part of the conference is what happens afterward. Send an email to individuals you met to establish a line of communication and thank them for their advice or insight. Did someone offer to share a protocol, start a collaboration, or introduce you to a colleague? Take them up on the offer! Notes that were taken in the app can also be emailed. In addition, registration includes 2 years of access to DDW On Demand, an online library of sessions. If there were any nonticketed presentations that you missed, you can watch them upon your return. Similarly, access missed posters at the DDW ePosters archive, where you can read poster abstracts and view ePosters, if submitted. Abstracts will still be viewable through the app and online planner as well. Reach out to colleagues if you have questions about their work!

Also, don’t forget to take what you learned back to your community. Share your new knowledge with your colleagues and trainees, and consider if there are any new concepts or approaches that should be implemented in your practice.

 

 

Practical tip

Before it falls off your radar, submit for CME credits for the sessions you attended. To claim CME, you may flag sessions for CME using the DDW Mobile App, visit a CME kiosk on site or access the DDW CME Claim Site after the meeting. Visit the DDW website for more information on claiming CME.

Dr. Lea Ann Chen

Refine, refocus, and recharge

DDW is the most comprehensive GI event in the world. Take advantage of the learning opportunities to improve your own work. Note how the landscape of GI is evolving and use it to reevaluate your own career development strategy and how you want to contribute to the field. Most importantly, get inspired. After exploring the most up-to-date advances and connecting with colleagues and thought leaders at DDW, you will hopefully return to your home institution feeling reinvigorated, refreshed, and ready to apply your newfound insights to your patient care or to your research.

See you at DDW!
 

References

1. Notices. Gastroenterology. 1969;569(1):188-9. http://www.gastrojournal.org/article/S0016-5085(69)80085-5/pdf.

2. Exhibitor Prospectus | Digestive Disease Week® 2018. https://higherlogicdownload.s3.amazonaws.com/GASTRO/44b1f1fd-aaed-44c8-954f-b0eaea6b0462/UploadedFiles/B4KUryNTNS5lEaFk6jBQ_DDW%202018%20Exhibitor%20Prospectus_Staffchanges.pdf

Dr. Chen is assistant professor of medicine, New York University School of Medicine.

It’s that time of the year again: Digestive Disease Week (DDW®)! This event evolved out of the AGA annual meetings and was first advertised as DDW in the January 1969 issue of Gastroenterology.1 Since that time, it has grown into a truly international event with over 14,000 attendees, 41% of whom attend from abroad.2

DDW is a collaborative event that is jointly sponsored by four professional GI/hepatology-related societies – the AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract. The conference topics cover the gamut of GI and hepatology conditions and participants represent all types of professional settings, including private practice (37%), hospitals (33%), and academic medical centers (28%).2 Whether you’re a first-time attendee or a seasoned participant, DDW offers something for everyone. Below are some tips on how to maximize the benefits of your attendance:
 

Plan ahead

Is there a new treatment or condition you’ve wanted to learn more about? Are you interested in testing the latest endoscopic devices or learning a new procedural technique? Experts from around the world come to DDW to showcase the latest developments in GI. However, with over 5,000 abstracts and lectures and almost 300 exhibition booths, it’s easy to feel overwhelmed by all the offerings. To make the most of your experience, plan ahead.

In the months prior to the conference, visit the DDW website to download the Preliminary Program. Pick out your can’t-miss lectures and events, and put them on your calendar right away. As DDW approaches, invitations from colleagues, societies, and industry grow, so preplanning is a necessity.

Approximately 1 month before DDW, the DDW Mobile App will become available for free download in the Apple and Google Play stores. You can highlight events of interest and place them on a personalized calendar. Allow for push notifications to get the latest updates and schedule changes throughout the event. In addition, the in-app maps of the venue are a fantastic way to locate where scheduled events will take place. Try to attend talks that are located close to one another. The conference center is expansive and you may miss your intended presentations by trying to catch overlapping sessions situated far from each other. If you prefer planning on a desktop or laptop, use the DDW Online Planner (available mid-April) to create your schedule. The information can then be synced to your mobile device through the app.

Upon arrival, be sure to pick up your attendee conference bag. Before recycling the contents, look for any product theaters, satellite symposia, exhibitor booths, or other advertised activities you may want to add to your schedule.

 

 

Practical tips

a) Register ahead of time and pick up your conference bag during off-hours to avoid long lines.

b) Book your hotel early. Most have generous cancellation policies. Registration is required before booking housing.

c) Pack comfortable shoes and dress in layers to accommodate both unpredictable weather and indoor climate control.

Make new connections and nurture old ones

Is your professional hero giving a talk? Are you looking to land your first job or make a move? Do you need some face time with a mentor outside your institution? DDW is a wonderful opportunity to connect with advisers and possible employers as well as potential and established collaborators. Schedules fill up quickly though, so try your best to email requests for meetings well ahead of time. The app also has a messaging feature you can use to communicate with other attendees.

At the meeting, be an active participant and ask questions. One of the greatest benefits of attending the conference is the opportunity to interact with others. For trainees and early career attendees, DDW is your debutante ball! Introduce yourself and your work to the broader GI community. Bring your business cards as well as a notebook to write down questions and comments about your study. Look engaging when standing by your poster and offer to walk visitors through your research. There will also be an opportunity to have free headshots taken in the Early Career area this year.

Also take advantage of DDW’s big draw to reconnect with old friends and colleagues from around the U.S. and the world. Schedule a time to catch up and swap stories. Learn from each other’s successes and mistakes. It’s good for the soul and your career.
 

Post-DDW

Attending DDW is only the start! The most important part of the conference is what happens afterward. Send an email to individuals you met to establish a line of communication and thank them for their advice or insight. Did someone offer to share a protocol, start a collaboration, or introduce you to a colleague? Take them up on the offer! Notes that were taken in the app can also be emailed. In addition, registration includes 2 years of access to DDW On Demand, an online library of sessions. If there were any nonticketed presentations that you missed, you can watch them upon your return. Similarly, access missed posters at the DDW ePosters archive, where you can read poster abstracts and view ePosters, if submitted. Abstracts will still be viewable through the app and online planner as well. Reach out to colleagues if you have questions about their work!

Also, don’t forget to take what you learned back to your community. Share your new knowledge with your colleagues and trainees, and consider if there are any new concepts or approaches that should be implemented in your practice.

 

 

Practical tip

Before it falls off your radar, submit for CME credits for the sessions you attended. To claim CME, you may flag sessions for CME using the DDW Mobile App, visit a CME kiosk on site or access the DDW CME Claim Site after the meeting. Visit the DDW website for more information on claiming CME.

Dr. Lea Ann Chen

Refine, refocus, and recharge

DDW is the most comprehensive GI event in the world. Take advantage of the learning opportunities to improve your own work. Note how the landscape of GI is evolving and use it to reevaluate your own career development strategy and how you want to contribute to the field. Most importantly, get inspired. After exploring the most up-to-date advances and connecting with colleagues and thought leaders at DDW, you will hopefully return to your home institution feeling reinvigorated, refreshed, and ready to apply your newfound insights to your patient care or to your research.

See you at DDW!
 

References

1. Notices. Gastroenterology. 1969;569(1):188-9. http://www.gastrojournal.org/article/S0016-5085(69)80085-5/pdf.

2. Exhibitor Prospectus | Digestive Disease Week® 2018. https://higherlogicdownload.s3.amazonaws.com/GASTRO/44b1f1fd-aaed-44c8-954f-b0eaea6b0462/UploadedFiles/B4KUryNTNS5lEaFk6jBQ_DDW%202018%20Exhibitor%20Prospectus_Staffchanges.pdf

Dr. Chen is assistant professor of medicine, New York University School of Medicine.

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Adopting new evidence into practice – a guide for the new gastroenterologist

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The transition from gastroenterology fellowship to independent practice can be daunting. There may be concerns about procedural competency and increased levels of responsibility. Recent trainees have to manage their newly busy clinical schedules while trying to integrate evidence from a rapidly evolving landscape of medical literature into daily practice. Many recent graduates also are expected to participate in financial decisions or contribute to assessments about resource allocation regarding new technologies. These are challenges faced by those in both community and academic positions but may be more keenly felt in the first years of practice regardless of setting.

Dr. David A. Leiman

Without the benefit of experience, incorporating pertinent evidence from both within and outside of the field of gastroenterology as well as identifying disruptive technologies can be particularly difficult. There is scant guidance in this area, either during fellowship or from the existing literature1. Yet these are skills that, when properly developed, can be lifelong assets and, as a result, an evaluation of this process is warranted. Herein, we identify recent developments relevant to gastroenterologists to illustrate a conceptual framework for judging novel information.

A practical concern for the new gastroenterologist is learning to efficiently evaluate the merits of the latest research and then implement this knowledge in the clinic. Maintaining active society membership often includes access to scholarly journals. For example, AGA members receive Gastroenterology, Clinical Gastroenterology and Hepatology, and Cellular and Molecular Gastroenterology and Hepatology as part of their member benefits and have the opportunity to receive alerts when new content is published. Social media outlets such as Twitter and Facebook also simplify the process for readers to identify high-impact studies2 (see social media urls at the end of the story). In addition to reading, however, a critical review of these studies can prevent premature enthusiasm for modifying practice. The evolving evidence base for understanding proton pump inhibitor (PPI) risks is illustrative. Several studies attracted widespread media attention describing serious associated side effects, ranging from MI3 to dementia4 and stroke5. These studies were provocative but a decision to withhold PPIs from patients based on these concerns alone could lead to unintended consequences with poor outcomes. Ultimately, subsequent studies published only months later challenged these associations.6-8 Instead, thoughtful disclosure to patients of known risks and appropriate indications for PPI therapy based on resources such as the AGA Best Practice Advice9 is prudent. Reading more may be necessary but is insufficient; finding a forum to discuss novel research topics, such as in a monthly journal club10 or group practice meeting, can lead to stimulating discussion about how to apply pertinent research to change practice. The AGA Community is an excellent venue for this kind of interaction.

In many situations, keeping informed of updates about the risks and safety of medications prescribed by nongastroenterologists, particularly as they relate to GI conditions, can be even more difficult. A prime example of this is the rapidly expanding literature on indications and risks of direct oral anticoagulants. Rotating on the inpatient consultation service, with the chance to interact with multiple non-GI providers, affords an excellent opportunity to stay up to date. With the increased prevalence of atrial fibrillation as well as the potential expanded indications for direct oral anticoagulants based on recent randomized, controlled trials11,12, practicing gastroenterologists will be comanaging increasing numbers of patients hospitalized with gastrointestinal bleeding (GIB). Our understanding of the availability and indication for targeted reversal agents, such as idarucizumab, as well as nonspecific reversal agents, such as prothrombin complex concentrates, for those with life-threatening GIB is critical to optimal management of these patients. Multidisciplinary collaborations, such as with cardiogastroenterology clinics13, can be leveraged for optimal management of direct oral anticoagulants in the periendoscopy period.

Traditional outpatient consultative approaches are sometimes necessary but frequent reference to consensus societal guidelines on endoscopy in patients on antithrombotics14 should be made, particularly if they are printed and readily available in the ambulatory clinic and endoscopy suites. When information may be too new or sparse to utilize a national guideline, employing local data or experience to create a hospital-specific algorithm can ensure the delivery of high-quality, collaborative patient care.

Dr. Neil Sengupta

Much like reviewing the literature, evaluating new technologies poses its own challenges. Changes in clinical practice may be slow, as in the adoption of noninvasive methods for Barrett’s esophagus screening.15 But in an age when news of advances and updates in management spreads at tremendous speed through the use of social media, the ability to pivot or assimilate new discoveries and techniques will become increasingly relevant and important. A professional society’s endorsement can provide a framework for a decision, but other principles at play include sensible, critical analyses of the outcomes and costs as well as a balance of organizational and societal perspectives.16 The use of impedance planimetry is one such example. This is a relatively new technology, but it has received increasing interest recently.17 The first questions when considering adopting this type of device likely will be about its supporting evidence and the risk for causing harm. The pace of publications regarding its use for measuring esophageal distensibility has accelerated18. But good data does not necessarily translate into extensive uptake. Other important factors also are practical, e.g., whether a technology committee’s approval is needed and what is the learning curve, available technical support, need for capital purchases, reimbursement, etc. Functional luminal imaging probe (FLIP®) technology was developed to assess compliance in primary esophageal disorders and now has been applied to several other areas including anorectal disease, bariatric surgery, and therapeutic endoscopy19,20. Although seemingly a niche market, there is potential widespread application and an opportunity for collaborations that might not have been evident at first blush. Ultimately, any evaluation of new technology is to a certain extent speculation. Is the technology mature or novel? If it is the latter, this may provide a marketing advantage and facilitate a relationship that could lead to academic partnerships.

Embracing new devices and modifications to existing practice paradigms happens on a spectrum21. We are reminded of the maxim, “never be the first or last to adopt change.” One must be on the lookout for revolutionary or game-changing advances but be cautious to avoid irresponsible enthusiasm. Whether it is incorporating evidence from a recent study into everyday practice or judging the potential of new equipment, a balance must be achieved between detailed evaluation of the literature and understanding the practical consequences and feasibility of implementing change. Although these may be competing interests, achieving this is a pivotal step in success for the new gastroenterologist.

 

 

AGA journals' social media accounts



http://twitter.com/aga_gastro

http://twitter.com/aga_cgh

http://twitter.com/aga_cmgh

https://www.facebook.com/gastrojournal/

https://www.facebook.com/cghjournal/

https://www.facebook.com/cmghjournal/

 

References

1. Arora V et al. Closing the gap between internal medicine training and practice: Recommendations from recent graduates. Am J Med. 2005 Jun;118(6):685-7.

2. Gray DM et al. Making social media work for your practice. Clin Gastroenterol Hepatol. 2017 Nov;15:1651-4.

3. Shah NH et al. Proton pump inhibitor usage and the risk of myocardial infarction in the general population. PLoS One. 2015 Jun 10;10:e0124653.

4. Gomm W et al. Association of proton pump inhibitors with risk of dementia: A pharmacoepidemiological claims data analysis. JAMA Neurol. 2016 Apr;73(4):410-6.

5. Wang YF et al. Proton-pump inhibitor use and the risk of first-time ischemic stroke in the general population: A nationwide population-based study. Am J Gastroenterol. 2017 Jul;112:1084-93.

6. Nguyen LH et al. No significant association between proton pump inhibitor use and risk of stroke after adjustment for lifestyle factors and indication. Gastroenterology. 2018 Apr; 154(5):1290-7.

7. Lochhead P et al. Association between proton pump inhibitor use and cognitive function in women. Gastroenterology. 2017 Oct;153(4):971-9.

8. Landi SN et al. No increase in risk of acute myocardial infarction in privately insured adults prescribed proton pump inhibitors vs histamine-2 receptor antagonists (2002-2014). Gastroenterology 2018 Mar;154(4):861-73.

9. Freedberg DE et al. The risks and benefits of long-term use of proton pump inhibitors: Expert review and best practice advise from the American Gastroenterological Association. Gastroenterology. 2017 Mar;152:706-15.

10. Judd S et al. Approach to presenting a clinical journal club. Gastroenterology. 2014 Jun;146(7):1591-3.

11. Weitz JI et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017 Mar 30;376:1211-22.

12. Eikelboom JW et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017 Oct. 5;377:1319-30.

13. Abraham NS. Novel oral anticoagulants and gastrointestinal bleeding: a case for cardiogastroenterology. Clin Gastroenterol Hepatol. 2013;11(4):324-8.

14. Acosta RD et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016;83:3-16.

15. Sami SS et al. Screening for Barrett’s esophagus and esophageal adenocarcinoma: rationale, recent progress, challenges and future directions. Clin Gastroenterol Hepatol. 2015 Apr;13:623-34.

16. Laupacis A et al. How attractive does a new technology need to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ. 1992 Feb 15;146:473-81.

17. Hirano I et al. Functional lumen imaging probe for the management of esophageal disorders: Expert review from the clinical practice updates committee of the AGA Institute. Clin Gastroenterol Hepatol. 2017 Mar;15:325-34.

18. Kwiatek MA et al. Esophagogastric junction distensibility assessed with an endoscopic functional luminal imaging probe (EndoFLIP). Gastrointest Endosc. 2010 Aug;72:272-82.

19. Leroi AM et al. The diagnostic value of the functional lumen imaging probe versus high-resolution anorectal manometry in patients with fecal incontinence. Neurogastroenterol Motil. 2018 Jan 18; doi: 10.1111/nmo.13291.

20. Reynolds JL et al. Intraoperative assessment of the effects of laparoscopic sleeve gastrectomy on the distensibility of the lower esophageal sphincter using impedance planimetry. Surg Endosc. 2016 Nov;30:4904-9.

21. Aisenberg J. Optical biopsy for colorectal polyps: moving along the S-shaped curve. Gastrointest Endosc. 2014 Mar;79:399-401.

Dr. Leiman, assistant professor of medicine, division of gastroenterology, Duke University, Durham, N.C.; Dr. Sengupta, assistant professor of medicine, section of gastroenterology, hepatology, and nutrition, University of Chicago Medical Center.

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The transition from gastroenterology fellowship to independent practice can be daunting. There may be concerns about procedural competency and increased levels of responsibility. Recent trainees have to manage their newly busy clinical schedules while trying to integrate evidence from a rapidly evolving landscape of medical literature into daily practice. Many recent graduates also are expected to participate in financial decisions or contribute to assessments about resource allocation regarding new technologies. These are challenges faced by those in both community and academic positions but may be more keenly felt in the first years of practice regardless of setting.

Dr. David A. Leiman

Without the benefit of experience, incorporating pertinent evidence from both within and outside of the field of gastroenterology as well as identifying disruptive technologies can be particularly difficult. There is scant guidance in this area, either during fellowship or from the existing literature1. Yet these are skills that, when properly developed, can be lifelong assets and, as a result, an evaluation of this process is warranted. Herein, we identify recent developments relevant to gastroenterologists to illustrate a conceptual framework for judging novel information.

A practical concern for the new gastroenterologist is learning to efficiently evaluate the merits of the latest research and then implement this knowledge in the clinic. Maintaining active society membership often includes access to scholarly journals. For example, AGA members receive Gastroenterology, Clinical Gastroenterology and Hepatology, and Cellular and Molecular Gastroenterology and Hepatology as part of their member benefits and have the opportunity to receive alerts when new content is published. Social media outlets such as Twitter and Facebook also simplify the process for readers to identify high-impact studies2 (see social media urls at the end of the story). In addition to reading, however, a critical review of these studies can prevent premature enthusiasm for modifying practice. The evolving evidence base for understanding proton pump inhibitor (PPI) risks is illustrative. Several studies attracted widespread media attention describing serious associated side effects, ranging from MI3 to dementia4 and stroke5. These studies were provocative but a decision to withhold PPIs from patients based on these concerns alone could lead to unintended consequences with poor outcomes. Ultimately, subsequent studies published only months later challenged these associations.6-8 Instead, thoughtful disclosure to patients of known risks and appropriate indications for PPI therapy based on resources such as the AGA Best Practice Advice9 is prudent. Reading more may be necessary but is insufficient; finding a forum to discuss novel research topics, such as in a monthly journal club10 or group practice meeting, can lead to stimulating discussion about how to apply pertinent research to change practice. The AGA Community is an excellent venue for this kind of interaction.

In many situations, keeping informed of updates about the risks and safety of medications prescribed by nongastroenterologists, particularly as they relate to GI conditions, can be even more difficult. A prime example of this is the rapidly expanding literature on indications and risks of direct oral anticoagulants. Rotating on the inpatient consultation service, with the chance to interact with multiple non-GI providers, affords an excellent opportunity to stay up to date. With the increased prevalence of atrial fibrillation as well as the potential expanded indications for direct oral anticoagulants based on recent randomized, controlled trials11,12, practicing gastroenterologists will be comanaging increasing numbers of patients hospitalized with gastrointestinal bleeding (GIB). Our understanding of the availability and indication for targeted reversal agents, such as idarucizumab, as well as nonspecific reversal agents, such as prothrombin complex concentrates, for those with life-threatening GIB is critical to optimal management of these patients. Multidisciplinary collaborations, such as with cardiogastroenterology clinics13, can be leveraged for optimal management of direct oral anticoagulants in the periendoscopy period.

Traditional outpatient consultative approaches are sometimes necessary but frequent reference to consensus societal guidelines on endoscopy in patients on antithrombotics14 should be made, particularly if they are printed and readily available in the ambulatory clinic and endoscopy suites. When information may be too new or sparse to utilize a national guideline, employing local data or experience to create a hospital-specific algorithm can ensure the delivery of high-quality, collaborative patient care.

Dr. Neil Sengupta

Much like reviewing the literature, evaluating new technologies poses its own challenges. Changes in clinical practice may be slow, as in the adoption of noninvasive methods for Barrett’s esophagus screening.15 But in an age when news of advances and updates in management spreads at tremendous speed through the use of social media, the ability to pivot or assimilate new discoveries and techniques will become increasingly relevant and important. A professional society’s endorsement can provide a framework for a decision, but other principles at play include sensible, critical analyses of the outcomes and costs as well as a balance of organizational and societal perspectives.16 The use of impedance planimetry is one such example. This is a relatively new technology, but it has received increasing interest recently.17 The first questions when considering adopting this type of device likely will be about its supporting evidence and the risk for causing harm. The pace of publications regarding its use for measuring esophageal distensibility has accelerated18. But good data does not necessarily translate into extensive uptake. Other important factors also are practical, e.g., whether a technology committee’s approval is needed and what is the learning curve, available technical support, need for capital purchases, reimbursement, etc. Functional luminal imaging probe (FLIP®) technology was developed to assess compliance in primary esophageal disorders and now has been applied to several other areas including anorectal disease, bariatric surgery, and therapeutic endoscopy19,20. Although seemingly a niche market, there is potential widespread application and an opportunity for collaborations that might not have been evident at first blush. Ultimately, any evaluation of new technology is to a certain extent speculation. Is the technology mature or novel? If it is the latter, this may provide a marketing advantage and facilitate a relationship that could lead to academic partnerships.

Embracing new devices and modifications to existing practice paradigms happens on a spectrum21. We are reminded of the maxim, “never be the first or last to adopt change.” One must be on the lookout for revolutionary or game-changing advances but be cautious to avoid irresponsible enthusiasm. Whether it is incorporating evidence from a recent study into everyday practice or judging the potential of new equipment, a balance must be achieved between detailed evaluation of the literature and understanding the practical consequences and feasibility of implementing change. Although these may be competing interests, achieving this is a pivotal step in success for the new gastroenterologist.

 

 

AGA journals' social media accounts



http://twitter.com/aga_gastro

http://twitter.com/aga_cgh

http://twitter.com/aga_cmgh

https://www.facebook.com/gastrojournal/

https://www.facebook.com/cghjournal/

https://www.facebook.com/cmghjournal/

 

References

1. Arora V et al. Closing the gap between internal medicine training and practice: Recommendations from recent graduates. Am J Med. 2005 Jun;118(6):685-7.

2. Gray DM et al. Making social media work for your practice. Clin Gastroenterol Hepatol. 2017 Nov;15:1651-4.

3. Shah NH et al. Proton pump inhibitor usage and the risk of myocardial infarction in the general population. PLoS One. 2015 Jun 10;10:e0124653.

4. Gomm W et al. Association of proton pump inhibitors with risk of dementia: A pharmacoepidemiological claims data analysis. JAMA Neurol. 2016 Apr;73(4):410-6.

5. Wang YF et al. Proton-pump inhibitor use and the risk of first-time ischemic stroke in the general population: A nationwide population-based study. Am J Gastroenterol. 2017 Jul;112:1084-93.

6. Nguyen LH et al. No significant association between proton pump inhibitor use and risk of stroke after adjustment for lifestyle factors and indication. Gastroenterology. 2018 Apr; 154(5):1290-7.

7. Lochhead P et al. Association between proton pump inhibitor use and cognitive function in women. Gastroenterology. 2017 Oct;153(4):971-9.

8. Landi SN et al. No increase in risk of acute myocardial infarction in privately insured adults prescribed proton pump inhibitors vs histamine-2 receptor antagonists (2002-2014). Gastroenterology 2018 Mar;154(4):861-73.

9. Freedberg DE et al. The risks and benefits of long-term use of proton pump inhibitors: Expert review and best practice advise from the American Gastroenterological Association. Gastroenterology. 2017 Mar;152:706-15.

10. Judd S et al. Approach to presenting a clinical journal club. Gastroenterology. 2014 Jun;146(7):1591-3.

11. Weitz JI et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017 Mar 30;376:1211-22.

12. Eikelboom JW et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017 Oct. 5;377:1319-30.

13. Abraham NS. Novel oral anticoagulants and gastrointestinal bleeding: a case for cardiogastroenterology. Clin Gastroenterol Hepatol. 2013;11(4):324-8.

14. Acosta RD et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016;83:3-16.

15. Sami SS et al. Screening for Barrett’s esophagus and esophageal adenocarcinoma: rationale, recent progress, challenges and future directions. Clin Gastroenterol Hepatol. 2015 Apr;13:623-34.

16. Laupacis A et al. How attractive does a new technology need to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ. 1992 Feb 15;146:473-81.

17. Hirano I et al. Functional lumen imaging probe for the management of esophageal disorders: Expert review from the clinical practice updates committee of the AGA Institute. Clin Gastroenterol Hepatol. 2017 Mar;15:325-34.

18. Kwiatek MA et al. Esophagogastric junction distensibility assessed with an endoscopic functional luminal imaging probe (EndoFLIP). Gastrointest Endosc. 2010 Aug;72:272-82.

19. Leroi AM et al. The diagnostic value of the functional lumen imaging probe versus high-resolution anorectal manometry in patients with fecal incontinence. Neurogastroenterol Motil. 2018 Jan 18; doi: 10.1111/nmo.13291.

20. Reynolds JL et al. Intraoperative assessment of the effects of laparoscopic sleeve gastrectomy on the distensibility of the lower esophageal sphincter using impedance planimetry. Surg Endosc. 2016 Nov;30:4904-9.

21. Aisenberg J. Optical biopsy for colorectal polyps: moving along the S-shaped curve. Gastrointest Endosc. 2014 Mar;79:399-401.

Dr. Leiman, assistant professor of medicine, division of gastroenterology, Duke University, Durham, N.C.; Dr. Sengupta, assistant professor of medicine, section of gastroenterology, hepatology, and nutrition, University of Chicago Medical Center.

The transition from gastroenterology fellowship to independent practice can be daunting. There may be concerns about procedural competency and increased levels of responsibility. Recent trainees have to manage their newly busy clinical schedules while trying to integrate evidence from a rapidly evolving landscape of medical literature into daily practice. Many recent graduates also are expected to participate in financial decisions or contribute to assessments about resource allocation regarding new technologies. These are challenges faced by those in both community and academic positions but may be more keenly felt in the first years of practice regardless of setting.

Dr. David A. Leiman

Without the benefit of experience, incorporating pertinent evidence from both within and outside of the field of gastroenterology as well as identifying disruptive technologies can be particularly difficult. There is scant guidance in this area, either during fellowship or from the existing literature1. Yet these are skills that, when properly developed, can be lifelong assets and, as a result, an evaluation of this process is warranted. Herein, we identify recent developments relevant to gastroenterologists to illustrate a conceptual framework for judging novel information.

A practical concern for the new gastroenterologist is learning to efficiently evaluate the merits of the latest research and then implement this knowledge in the clinic. Maintaining active society membership often includes access to scholarly journals. For example, AGA members receive Gastroenterology, Clinical Gastroenterology and Hepatology, and Cellular and Molecular Gastroenterology and Hepatology as part of their member benefits and have the opportunity to receive alerts when new content is published. Social media outlets such as Twitter and Facebook also simplify the process for readers to identify high-impact studies2 (see social media urls at the end of the story). In addition to reading, however, a critical review of these studies can prevent premature enthusiasm for modifying practice. The evolving evidence base for understanding proton pump inhibitor (PPI) risks is illustrative. Several studies attracted widespread media attention describing serious associated side effects, ranging from MI3 to dementia4 and stroke5. These studies were provocative but a decision to withhold PPIs from patients based on these concerns alone could lead to unintended consequences with poor outcomes. Ultimately, subsequent studies published only months later challenged these associations.6-8 Instead, thoughtful disclosure to patients of known risks and appropriate indications for PPI therapy based on resources such as the AGA Best Practice Advice9 is prudent. Reading more may be necessary but is insufficient; finding a forum to discuss novel research topics, such as in a monthly journal club10 or group practice meeting, can lead to stimulating discussion about how to apply pertinent research to change practice. The AGA Community is an excellent venue for this kind of interaction.

In many situations, keeping informed of updates about the risks and safety of medications prescribed by nongastroenterologists, particularly as they relate to GI conditions, can be even more difficult. A prime example of this is the rapidly expanding literature on indications and risks of direct oral anticoagulants. Rotating on the inpatient consultation service, with the chance to interact with multiple non-GI providers, affords an excellent opportunity to stay up to date. With the increased prevalence of atrial fibrillation as well as the potential expanded indications for direct oral anticoagulants based on recent randomized, controlled trials11,12, practicing gastroenterologists will be comanaging increasing numbers of patients hospitalized with gastrointestinal bleeding (GIB). Our understanding of the availability and indication for targeted reversal agents, such as idarucizumab, as well as nonspecific reversal agents, such as prothrombin complex concentrates, for those with life-threatening GIB is critical to optimal management of these patients. Multidisciplinary collaborations, such as with cardiogastroenterology clinics13, can be leveraged for optimal management of direct oral anticoagulants in the periendoscopy period.

Traditional outpatient consultative approaches are sometimes necessary but frequent reference to consensus societal guidelines on endoscopy in patients on antithrombotics14 should be made, particularly if they are printed and readily available in the ambulatory clinic and endoscopy suites. When information may be too new or sparse to utilize a national guideline, employing local data or experience to create a hospital-specific algorithm can ensure the delivery of high-quality, collaborative patient care.

Dr. Neil Sengupta

Much like reviewing the literature, evaluating new technologies poses its own challenges. Changes in clinical practice may be slow, as in the adoption of noninvasive methods for Barrett’s esophagus screening.15 But in an age when news of advances and updates in management spreads at tremendous speed through the use of social media, the ability to pivot or assimilate new discoveries and techniques will become increasingly relevant and important. A professional society’s endorsement can provide a framework for a decision, but other principles at play include sensible, critical analyses of the outcomes and costs as well as a balance of organizational and societal perspectives.16 The use of impedance planimetry is one such example. This is a relatively new technology, but it has received increasing interest recently.17 The first questions when considering adopting this type of device likely will be about its supporting evidence and the risk for causing harm. The pace of publications regarding its use for measuring esophageal distensibility has accelerated18. But good data does not necessarily translate into extensive uptake. Other important factors also are practical, e.g., whether a technology committee’s approval is needed and what is the learning curve, available technical support, need for capital purchases, reimbursement, etc. Functional luminal imaging probe (FLIP®) technology was developed to assess compliance in primary esophageal disorders and now has been applied to several other areas including anorectal disease, bariatric surgery, and therapeutic endoscopy19,20. Although seemingly a niche market, there is potential widespread application and an opportunity for collaborations that might not have been evident at first blush. Ultimately, any evaluation of new technology is to a certain extent speculation. Is the technology mature or novel? If it is the latter, this may provide a marketing advantage and facilitate a relationship that could lead to academic partnerships.

Embracing new devices and modifications to existing practice paradigms happens on a spectrum21. We are reminded of the maxim, “never be the first or last to adopt change.” One must be on the lookout for revolutionary or game-changing advances but be cautious to avoid irresponsible enthusiasm. Whether it is incorporating evidence from a recent study into everyday practice or judging the potential of new equipment, a balance must be achieved between detailed evaluation of the literature and understanding the practical consequences and feasibility of implementing change. Although these may be competing interests, achieving this is a pivotal step in success for the new gastroenterologist.

 

 

AGA journals' social media accounts



http://twitter.com/aga_gastro

http://twitter.com/aga_cgh

http://twitter.com/aga_cmgh

https://www.facebook.com/gastrojournal/

https://www.facebook.com/cghjournal/

https://www.facebook.com/cmghjournal/

 

References

1. Arora V et al. Closing the gap between internal medicine training and practice: Recommendations from recent graduates. Am J Med. 2005 Jun;118(6):685-7.

2. Gray DM et al. Making social media work for your practice. Clin Gastroenterol Hepatol. 2017 Nov;15:1651-4.

3. Shah NH et al. Proton pump inhibitor usage and the risk of myocardial infarction in the general population. PLoS One. 2015 Jun 10;10:e0124653.

4. Gomm W et al. Association of proton pump inhibitors with risk of dementia: A pharmacoepidemiological claims data analysis. JAMA Neurol. 2016 Apr;73(4):410-6.

5. Wang YF et al. Proton-pump inhibitor use and the risk of first-time ischemic stroke in the general population: A nationwide population-based study. Am J Gastroenterol. 2017 Jul;112:1084-93.

6. Nguyen LH et al. No significant association between proton pump inhibitor use and risk of stroke after adjustment for lifestyle factors and indication. Gastroenterology. 2018 Apr; 154(5):1290-7.

7. Lochhead P et al. Association between proton pump inhibitor use and cognitive function in women. Gastroenterology. 2017 Oct;153(4):971-9.

8. Landi SN et al. No increase in risk of acute myocardial infarction in privately insured adults prescribed proton pump inhibitors vs histamine-2 receptor antagonists (2002-2014). Gastroenterology 2018 Mar;154(4):861-73.

9. Freedberg DE et al. The risks and benefits of long-term use of proton pump inhibitors: Expert review and best practice advise from the American Gastroenterological Association. Gastroenterology. 2017 Mar;152:706-15.

10. Judd S et al. Approach to presenting a clinical journal club. Gastroenterology. 2014 Jun;146(7):1591-3.

11. Weitz JI et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017 Mar 30;376:1211-22.

12. Eikelboom JW et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017 Oct. 5;377:1319-30.

13. Abraham NS. Novel oral anticoagulants and gastrointestinal bleeding: a case for cardiogastroenterology. Clin Gastroenterol Hepatol. 2013;11(4):324-8.

14. Acosta RD et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016;83:3-16.

15. Sami SS et al. Screening for Barrett’s esophagus and esophageal adenocarcinoma: rationale, recent progress, challenges and future directions. Clin Gastroenterol Hepatol. 2015 Apr;13:623-34.

16. Laupacis A et al. How attractive does a new technology need to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ. 1992 Feb 15;146:473-81.

17. Hirano I et al. Functional lumen imaging probe for the management of esophageal disorders: Expert review from the clinical practice updates committee of the AGA Institute. Clin Gastroenterol Hepatol. 2017 Mar;15:325-34.

18. Kwiatek MA et al. Esophagogastric junction distensibility assessed with an endoscopic functional luminal imaging probe (EndoFLIP). Gastrointest Endosc. 2010 Aug;72:272-82.

19. Leroi AM et al. The diagnostic value of the functional lumen imaging probe versus high-resolution anorectal manometry in patients with fecal incontinence. Neurogastroenterol Motil. 2018 Jan 18; doi: 10.1111/nmo.13291.

20. Reynolds JL et al. Intraoperative assessment of the effects of laparoscopic sleeve gastrectomy on the distensibility of the lower esophageal sphincter using impedance planimetry. Surg Endosc. 2016 Nov;30:4904-9.

21. Aisenberg J. Optical biopsy for colorectal polyps: moving along the S-shaped curve. Gastrointest Endosc. 2014 Mar;79:399-401.

Dr. Leiman, assistant professor of medicine, division of gastroenterology, Duke University, Durham, N.C.; Dr. Sengupta, assistant professor of medicine, section of gastroenterology, hepatology, and nutrition, University of Chicago Medical Center.

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